Patent Docs

iNO Therapeutics LLC v. Praxair Distribution Inc. (Fed. Cir. 2019)

By Kevin E. Noonan --

Albert Einstein once famously (albeit perhaps apocryphally) said that "[c]ompound interest is the most powerful force in the universe."  Not to contradict the creator of 20th Century physics, but it is just as likely that the most powerful force in the universe is the power of unintended consequences.  The Federal Circuit illustrated this power in its recent decision in iNo Therapeutics LLC v. Praxair Distribution Inc. with regard to Justice Breyer's exhortation, in his Mayo Collaborative Serv. Inc. v. Prometheus Laboratories opinion, regarding the need to beware of "interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art' without reference to the 'principles un­derlying the prohibition against patents for [natural laws],'" citing Flook v. Parker.

Plaintiffs iNO Therapeutics, LLC, Mallinckrodt Hospital Products Inc., and Mallinckrodt Hospital Products IP Inc. asserted U.S. Patent Nos. 8,282,966; 8,293,284; 8,795,741; 8,431,163; and 8,846,112, which the opinion "collectively [termed the] 'heart failure patents' or 'HF patents'" against Praxair Distribution Inc. and Praxair Inc.  Plaintiffs also asserted U.S. Patent Nos. 8,573,209; 8,776,794; 8,776,795; 9,265,911; and 9,295,802 which the opinion "collectively [termed the] 'delivery system infrared patents' or 'DSIR patents'" and which were directed to devices for administering nitric oxide gas.  As explained in the opinion, inhaled nitric oxide (iNO) gas had been "used to treat infants experiencing hypoxic respiratory failure" since at least the early 1990's.  However, in certain cases this treatment results in increased pulmonary edema for infants having a congenital defect, left ventricular hypertrophy.  The patents-in-suit were directed to methods and a gas delivery device to ameliorate this side-effect, as exemplified by the following claims:

The '741 patent:

1.  A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure (PCWP) leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, the method comprising:
    (a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment;
    (b) determining that a first patient of the plurality does not have left ventricular dysfunction;
    (c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide;
    (d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and
    (e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.

The '794 patent:

1.  A gas delivery device comprising:
    a gas source to provide therapy gas comprising nitric oxide;
    a valve attachable to the gas source, the valve including an inlet and an outlet in fluid communication and a valve actuator to open or close the valve to allow the gas through the valve to a control module that delivers the therapy gas comprising nitric oxide in an amount effective to treat or prevent hypoxic respiratory failure; and
    a circuit including:
    a memory to store gas data comprising one or more of gas identification, gas expiration date and gas concentration; and
    a processor and a transceiver in communication with the memory to send and receive signals to communicate the gas data to the control module that controls gas delivery to a subject and to verify one or more of the gas identification, the gas concentration and that the gas is not expired.

(where the italicized limitations are relevant to the Court's decision).  The opinion also notes that the Court had earlier affirmed the PTAB's invalidation of the '112 patent in inter partes review (see "Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd. (Fed. Cir. 2018)").

The District Court held the claims of the HF patents to be directed to patent-ineligible subject matter under 35 U.S.C. § 101, and that Praxair did not infringe the claims of the DSIR patents.  Mallinckrodt appealed.

The Federal Circuit affirmed-in-part, vacated-in-part, and remanded, in an opinion by Chief Judge Prost joined by Judge Dyk; Judge Newman concurred in part and dissented in part (but the thrust of her opinion dissented from the majority's routine and now conventional, but not capable of being well-understood, affirmance that the claims were not eligible for patenting under § 101).  The Court applied its now well-worn (and unnecessarily expansive) interpretation of the Supreme Court's Mayo/Alice test in affirming the District Court.  Dissecting the claims in furtherance of its patent-invalidating efforts, the panel majority first states that:

It is undisputed that treatment of infants experiencing hypoxic respiratory failure with iNO gas has existed for decades.  The inventors observed an adverse event that iNO gas causes for certain patients.  The patent claim does no more than add an instruction to withhold iNO treatment from the identified patients; it does not recite giving any affirmative treatment for the iNO-excluded group, and so it covers a method in which, for the iNO-excluded patients, the body's natural processes are simply allowed to take place.  Consequently, the claim here is directed to the natural phenomenon.  The claim, apart from the natural phenomenon itself, involves only well-understood, routine, and conventional steps.  For the reasons below, claim 1 of the '741 patent fails to recite eligible subject matter.

What follows is the majority's justification for this conclusion.  The natural phenomenon is "undisputed" (because the majority defines it as such), the majority saying "[a] neonate patient's body will react to iNO gas in a certain way depending on whether or not the patient has a congenital heart condition called LVD," followed by a recitation of the consequences thereof.  The panel majority then parsed the claim language to find that the claims are "directed to" an observation of the natural phenomenon they have defined, because the exclusion (from treatment) step "merely restates the natural law" (nature it seems providing a caregiver who can give the gas as well as knowing without benefit of the invention when to refrain from giving it).  According to the majority:

Properly understood, this added step [characterized by Mallinckrodt as an "exclusion" step] is simply an instruction not to act.  In effect, the claim is directed to detecting the presence of LVD in a patient and then doing nothing but leaving the natural processes taking place in the body alone for the group of LVD patients.  Accordingly, the claim is directed to the natural phenomenon.

And to avoid any correspondence with Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the majority asserted:

Indeed, Mallinckrodt cannot dispute that the patented method does not propose a new way of treating LVD patients that leverages this discovery (e.g., by titrating the iNO dose).  Instead, the claim simply requires that the patient not be treated with iNO.  This is significant because a claim not to treat—i.e., not to disturb these naturally-occurring physiological processes within the LVD patient's body—risks monopolizing the natural processes themselves.

And returning to the opinion's theme:

A closer look at the claim language as a whole confirms that the focus of the invention is not on a new way of actually treating the underlying condition of hypoxic respiratory failure.  Nor does it recite a way of reducing the risk of pulmonary edema while providing some level of treatment to those patients.  Rather, the focus of the invention is screening for a particular adverse condition that, once identified, requires iNO treatment be withheld.  A treatment step of administering a prior art dosage is also present.  But that step is plainly not the focus of the claimed invention.  Mallinckrodt concedes this step is not innovative.  Mallinckrodt does not point to "any innovation other than its [purported] discovery of the natural law," citing Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 750 (Fed. Cir. 2019).

The opinion also cites Nat. Alternatives Int'l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019), and Endo Pharm. Inc. v. Teva Pharm. USA, Inc., 919 F.3d 1347 (Fed. Cir. 2019), in support of the majority's distinction between these claims and what it considers "method of treatment" claims.  The panel further distinguished these claims from the patent-eligible claims in Rapid Litigation Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016) (a decision also written by the Chief), again on the grounds of "a careful reading of the claim language" in those claims and these.

With regard to the second step of the Mayo/Alice test, the panel majority rejected Mallinckrodt's argument that the claims possess an "inventive concept."  Following their wont, the majority found nothing sufficiently novel to warrant satisfaction of the second step inquiry.  It is a tribute to the essential blurring of statutory lines engendered by Justice Breyer's Mayo decision (but much less understandable or forgivable when the nation's "patent court" does so) that the discussion revolves expressly on lack of novelty in performing the eligibility analysis ("This would be quite a different case if the inventors had invented a new way of titrating the dose" and, citing the District Court (which doesn't take a putatively specialized appellate court to do), "Plaintiffs cannot seriously contend that it is a new practice to exclude certain patients from treatment with a drug when those patients are at an increased risk of experiencing negative side effects from the drug").  Understandably, the majority took frank recourse to what they perceive to be the parallels between these claims and the claims in Mayo to support their decision.  And the majority characterized as a "red herring" Mallinckrodt's contentions that their claims do not entirely preempt the putative natural phenomenon, surprising in view of the role preemption plays in justifying the Supreme Court's eligibility requirements in the first place.

The majority's consideration of infringement of the DSIR patents is more legally conventional, involving Mallinckrodt's disagreement with the District Court's construction of the term "verify" in the phrase "verify one or more of the gas identification, the gas concentration and that the gas is not expired."  The majority correctly noted that the District Court didn't formally construe the word, giving it its plain and ordinary meaning.  The opinion characterizes this argument as Mallinckrodt "attempt[ing] to undo its loss on infringement by redrawing the metes and bounds of the claim" and finds this effort "unavailing."

Providing one basis for Judge Newman to agree with her colleagues, the opinion reversed a "technical error" by the District Court and remanded for correction of the Court's "clerical error" (specifically, issuing a "blanket" judgment on all the claims of the asserted patents rather than limiting it to the asserted claims).

Judge Newman's dissent is directed to the eligibility portion of the decision.  In her view, the inventors observed a natural phenomenon and then developed a treatment method that took advantage of that observation to avoid adverse events.  "The method that is described and claimed does not exist in nature; it was designed by and is administered by humans" in her view.  Procedurally, Judge Newman faults her colleagues because:

The majority improperly separates the claims into old and new steps, describes some claim steps as a "natural phenomenon" and some steps as "well-understood, routine, and conventional steps," and avoids the requirement that a claimed invention is considered as a whole.

And "[t]oday's change of law adds to the inconsistency and unpredictability of this area of patent-supported innovation."  In Judge Newman's view "the majority's ruling conflicts with extensive precedent" (which she extensively cites) as well as "the national interest":

The majority [states that] "we emphasize the narrowness of our holding today, which is limited to the particular claims at issue and is driven by the particular circumstances here."  This disclaimer appears at the end of a lengthy exposition, whose wide-ranging pronouncements of law and policy are not tied to narrow circumstances or claims.  The persistent theme of the majority's analysis is that if a claim contains limitations that concern human physiology, ineligibility arises under section 101, whether or not the claimed method of medical treatment meets the requirement of patentability.

The majority's broad pronouncement of ineligibility of medical treatment that relates to human physiology not only contravenes precedent, but contravenes the national interest in achieving new methods of medical treatment with the assistance of the patent incentive.

Reaching back more than two centuries, Judge Newman reminds her colleagues that patents do not function to "impede scientific and technologic advance," citing Whittemore v. Cutter, 29 F. Cas. 1120, 1121 (C.C.D. Mass. 1813), based on common law and statutory research exemptions, citing her dissent in Integra Lifesciences I, Ltd. v. Merck KGaA, 331 F.3d 860, 875 (Fed. Cir. 2003), and Giles Sutherland Rich in Principles of Patentability, 28 Geo. Wash. L. Rev. 393, 400 (1960) ("It should never be forgotten that patented inventions are published and become a part of the technical literature.  This publication itself promotes progress in the useful arts and it is the prospect of patent rights which induces disclosure and the issuance of the patent which makes it available.")

Returning to the majority's blessedly non-precedential opinion, it will bring cold comfort to patent-divested patentees, as well as being somewhat ironic that the upshot of the opinion leads patent prosecutors to the inevitable conclusion that the Federal Circuit is counseling exactly what Justice Breyer cautioned against in Mayo, that we should beware of the clever draftsman who attempts (or worse, succeeds) in obtaining claims that are enforceable and pass the patent eligibility test that the Federal Circuit has crafted, based predominantly on such claim-drafting cleverness.  This is not the first time that this has been the outcome of the Federal Circuit's patent eligibility jurisprudence.  For example, in In re Roslyn, Judge Dyk's opinion held patent-ineligible claims to Dolly the sheep which was, after all, just a sheep (notwithstanding being a sheep unlike any sheep that had ever lived).  But a careful review of that opinion leads ineluctably to the conclusion that, had the draftsman been clever enough (or prescient enough to realize before the fact the quantum and quality of cleverness required) to have claimed a flock of genetically identical sheep, the Court's objections to patent ineligibility would have perforce fallen, because it would be undeniable that flocks of genetically identical sheep do not occur in nature.  This state of affairs is frankly Byzantine and antithetical to Congress's purpose (uniformity and predictability in U.S. patent law) for creating the Federal Circuit, as well as being contrary to the principles of clarity and the creation of "bright line rules" that arguably prompted the Supreme Court to begin its heightened scrutiny of the Court and its opinions (if not philosophy).  The Federal Circuit's current path is contrary to the idea that patent claims should be readily understandable to well-intended business people and frank (or in current parlance, "efficient") infringers alike and also contrary to the Founders' attitudes regarding patenting as a way to encourage disclosure of new inventions for the public good.  Having such a path will give little relief to those who have lost patent rights under the current regime, but at least it provides a way for inventors to obtain patent-eligible claims no matter what other branches of government do in addressing this issue.  Innovation, especially in the diagnostic and life sciences arts, requires no more and is entitled to no less.

iNO Therapeutics LLC v. Praxair Distribution Inc. (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Newman and Dyk
Opinion by Chief Judge Prost; opinion concurring in part and dissenting in part by Circuit Judge Newman

Federal Circuit Invalidates A. G. Bell's Telegraphy Patent

By Michael Borella --

June 23, 1880

WASHINGTON D.C.  In a unanimous panel ruling, the Federal Circuit invalidated a patent owned by Salem, Massachusetts inventor A. G. Bell.  On February 14, 1876, Mr. Bell was granted Letters Patent No. 174,465 to an "Improvement in Telegraphy."  This patent was challenged in various proceedings by Mr. Elisha Gray of Highland Park, Illinois as allegedly entailing subject matter ineligible for patenting.  In a long-awaited ruling, the Federal Circuit held that Mr. Bell's claims were directed to an abstract idea without significantly more and therefore invalid.

The claims of the '465 patent recite:

1.  A system of telegraphy in which the receiver is set in vibration by the employment undulatory currents of electricity, substantially as set forth.

2.  The combination, substantially as set forth, of a permanent magnet or other body capable of inductive action, with a closed circuit, so that the vibration of the one shall occasion electrical undulations in the other, or in itself, and this I claim, whether the permanent magnet beset in vibration in the neighborhood of the conducting-wire form simultaneously be set in vibration in each others neighborhood.

3.  The method of producing undulations in a continuous voltaic current by the vibration or motion of bodies capable of inductive action, or by the vibration or motion of the conducting-wire itself, in the neighborhood of such bodies, as set forth.

4.  The method of producing undulations in a continuous voltaic circuit by gradually increasing and diminishing the resistance of the circuit, or by gradually increasing and diminishing the power of the battery, as set forth.

5.  The method of, and apparatus for, transmitting vocal or other sounds telegraphically, as herein described, by causing electrical undulations, similar in form to the vibrations of the air accompanying the said vocal or other sound, substantially as set forth.

The Court began its analysis by inferring the scope of the claimed invention.  To do so, it considered the specification of the '465 patent, writing "[o]ur cases have found the specification helpful in illuminating whether a claim is truly focused on an ineligible abstract idea or significantly more than just that."  To that point, the Court observed that:

The eligibility inquiry may involve looking to the specification to understand the problem facing the inventor and, ultimately, what the patent describes as the invention.  The problem identified by Mr. Bell, as stated in the specification, is that intermittent electrical currents sent along a telegraphic wire become effectively continuous when subjected to numerous transmissions of different rates of vibration, making this technique unsuitable for accurately transmitting sounds.  Mr. Bell's solution is to represent sounds by transmitting undulatory currents instead, which are physical phenomenon mathematically similar to sinusoidal motions of air caused by these sounds.

The Court then found that "looking at the problem identified, as well as the way the inventor describes the invention, the specification suggests that the invention is nothing more than the abstract idea of communicating sounds over a wire."  The Court noted that humans have communicated audibly since time immemorial -- that such vocalization was a fundamental aspect of and long prevalent in the human experience.  Further, the use of various types of audible and non-audible waveforms for communication over a distance -- such as those involved in or generated by drumming, shouting, signal fires, mirrors, semaphores, and so-called optical telegraphs -- have been used for centuries, if not millennia.

Notably, the Court made an analogy between Mr. Bell's claims and those found invalid by the Supreme Court in O'Reilly v. Morse.  Mr. Morse's invention was directed to using electromagnetism to telegraphically transmit intelligible signals, and was found to be an abstraction -- an "idea" rather than a practical application thereof.  In that case, the Justices expressed concern that Mr. Morse's broad claims would cover any possible application of communicating at a distance via electromagnetism.  Similar to those of Morse, Mr. Bell's claims are sufficiently broad enough to be directed to a principle ("all solutions for attaining a desired result") rather than a specific implementation of that principle ("a specific embodiment that produces the desired result in a particular fashion").

While the Court acknowledged that Mr. Bell described such communication in the context of telegraphy using undulatory currents, "[t]he prohibition against patenting abstract ideas cannot be circumvented by attempting to limit the use of the idea to a particular technological environment."  Again, the language of the claims supported the Court's determination, as they were "recited at such a high level of generality that the claimed scope encompasses representing sounds of all types with electrical undulations."  In support of this determination, the Court pointed to the specification where Mr. Bell wrote "I desire here to remark that there are many other uses to which these instruments may be put, such as the simultaneous transmission of musical notes, differing in loudness as well as in pitch, and the telegraphic transmission of noises or sounds of any kind."

Thus, the Court concluded that "the claims clearly involve an abstract idea -- namely, the abstract idea of transmitting representations of sounds over a telegraphic wire."

Moving on to the next step of the patent eligibility inquiry, the Court sought to determine whether the additional elements of the claims included an "inventive concept" that would limit their coverage to be significantly more than the abstraction therein.  The Court explained this step as involving "consideration of the additional elements of the claim both individually and as an ordered combination to determine whether these elements transform the nature of the claim into a patent-eligible application."  Such additional elements cannot be "well-understood, routine, or conventional articles previously known in the relevant art."  Thus, "transformation into a patent-eligible application requires more than simply stating the abstract idea while adding the words 'apply it.'"

The Court determined that the additional claim elements above and beyond those reciting the abstract idea were "a receiver, a telegraphic line, and various mechanisms for generating electrical undulations in said line."  But each of these elements fell under the "well-understood, routine, or conventional" rubric.  The Court quickly observed that receivers and telegraphic lines have been used in communication systems for decades, and included those of Mr. Morse.

Moreover, the Court noted that not all of the claims explicitly recited mechanisms for generating electrical undulations, and that Mr. Bell had made admissions in the specification that any such mechanisms were already known.  For example, Mr. Bell disclosed that it was well-understood that a permanent magnet could be used for this purpose:

It has long been known that when a permanent magnet is caused to approach the pole of an electro-magnet a current of electricity is induced in the coils of the latter, and that when it is made to recede a current of opposite polarity to the first appears upon the wire.  When, therefore, a permanent magnet is caused to vibrate in front of the pole of an electromagnet an undulatory current of electricity is induced in the coils of the electro-magnet.

Mr. Bell went on to state that:

There are many ways of producing undulatory currents of electricity, dependent for effect upon the vibrations or motions of bodies capable of inductive action.  A few of the methods that may be employed I shall here specify.  When a wire, through which a continuous current of electricity is passing, is caused to vibrate in the neighborhood of another wire, an undulatory current of electricity is induced in the latter.  When a cylinder, upon which are arranged bar magnets, is made to rotate in front of the pole of an electromagnet, an undulatory current of electricity is induced in the coils of the electro-magnet.

In the Court's view, these additional elements were, by Mr. Bell's own admission, pre-existing articles.  Further, they were merely being used "for their intended purpose with no improvement made thereto."  Indeed, "Mr. Bell did not invent electro-magnets, wires, or cylinders of bar magnets, nor was he the first to observe that these items can induce undulatory currents."  Particularly, "electromagnetic induction had been discovered by the Englishman Michael Faraday nearly half a century ago, and was a well-understood phenomenon at the time of the patent's filing."

Therefore, the Court found that "[t]hese conventional components, all recited functionally at a high level and in a generic way, are no better equipped to save the claims from abstractness."  Furthermore, "when considered as an ordered combination, these elements add nothing that is not already present when looking at the elements taken individually . . . [t]here is no indication that the combination of elements improves the functioning of a receiver, the wires, or any magnets used in various claims."

Consequently, the Federal Circuit concluded that the '465 patent was invalid due to being directed to patent-ineligible subject matter, and Mr. Bell has lost exclusive rights to his invention.

Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH (Fed. Cir. 2019)

By Donald Zuhn --

Earlier this month, in Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia granting a motion for judgment as a matter of law filed by Appellee Genetic Veterinary Sciences, Inc., d/b/a Paw Prints Genetics ("PPG"), and as a result, found that the asserted claims of U.S. Patent Nos. 9,157,114 were patent ineligible under 35 U.S.C. § 101.  The Federal Circuit also affirmed the District Court's denial of a motion to dismiss PPG's complaint for lack of subject-matter jurisdiction and lack of personal jurisdiction filed by Appellants LABOKLIN GmbH & Co. KG ("LABOKLIN") and the University of Bern ("the University").

The '114 patent, which is owned by the University, relates to in vitro methods for genotyping Labrador Retrievers, in order to discover whether a dog might be a genetic carrier of Hereditary Nasal Parakeratosis ("HNPK"), a disease that causes crusts and fissures to appear on a dog's nose.  A professor at the University discovered that the presence of HNPK in Labrador Retrievers resulted from a point mutation in the gene SUV39H2.  Claims 1-3 of the '114 patent recite:

1.  An in vitro method for genotyping a Labrador Retriever comprising:
a) obtaining a biological sample from the Labrador Retriever;
b) genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1 and
c) detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2.

2.  The method according to claim 1, wherein the genotyping is achieved by PCR, real-time PCR, melting point analysis of double-stranded DNA, mass spectroscopy, direct DNA sequencing, restriction fragment length polymorphism (RFLP), single strand conformation polymorphism (SSCP), high performance liquid chromatography (HPLC), or single base primer extension.

3.  The method of claim 1, wherein the genotyping utilizes a primer pair comprising a first primer and a second primer, each comprising a contiguous span of at least 14 nucleotides of the sequence SEQ ID NO: 2 or a sequence complementary thereto, wherein:
a) said first primer hybridizes to a first DNA strand of the SUV39H2 gene;
b) said second primer hybridizes to the strand complementary to said first DNA strand of the SUV39H2 gene; and
c) the 3' ends of said first and second primers are located on regions flanking the position 972 of SEQ ID NO: 2, or of nucleotide positions complementary thereto.

The University, which is an instrumentality of the Swiss Confederation having a place of business in Bern, Switzerland, granted an exclusive license for the '114 patent to LABOKLIN, which is a German company with its principal place of business Bad Kissingen, Germany.  LABOKLIN entered into two sublicenses of the '114 patent in the United States.  PPG offers laboratory services for testing for genetic variations and mutations known to cause certain diseases in dogs, including a test for detecting the presence of a mutation in the SUV39H2 gene.

In January 2017, after obtaining the consent of the University, LABOKLIN sent a cease-and-desist letter to PPG asserting that PPG had infringed the '114 patent.  PPG responded by filing suit against LABOKLIN and the University and seeking a declaratory judgment that the asserted claims of the '114 patent are patent ineligible under § 101.  LABOKLIN and the University moved to dismiss PPG's complaint for lack of subject-matter jurisdiction and lack of personal jurisdiction.  The District Court, however, issued an Order finding jurisdiction established over both LABOKLIN and the University.  The dispute proceeded to trial on PPG's invalidity defense, and following the close of both parties' evidence, but before the case was submitted to the jury, the District Court granted PPG's motion for judgment as a matter of law and found the asserted claims patent-ineligible under § 101.

On appeal, LABOKLIN and the University argued that the District Court lacked personal jurisdiction over LABOKLIN because LABOKLIN lacked sufficient contacts with the forum, and lacked personal and subject-matter jurisdiction over the University because the University enjoyed sovereign immunity.  With respect to Appellants' argument that the District Court lacked personal jurisdiction over LABOKLIN, the Federal Circuit disagreed with Appellants' assertion that a cease-and-desist letter along with licensing activity in the forum was not enough to confer jurisdiction.  The Federal Circuit stated that "[a]s the District Court aptly pointed out, here, 'LABO[KLIN] is not merely a remote patentee assisting a U.S. company with enforcement, but instead, it is the U.S. enforcer.'"  The Federal Circuit therefore determined that the facts of the case established that LABOKLIN's activities satisfy the minimum contacts requirement without offense to due process, and thus, personal jurisdiction over LABOKLIN in the District Court was reasonable and fair.

Turning to Appellants' argument that the District Court lacked personal and subject-matter jurisdiction over the University because the University enjoyed sovereign immunity, the Federal Circuit began by noting that under the Foreign Sovereign Immunities Act ("FSIA"), "a foreign state is presumptively immune from the jurisdiction of United States courts; unless a specified exception applies, a federal court lacks subject-matter jurisdiction over a claim against a foreign state," and that under 28 U.S.C. § 1605(a)(2), if a foreign state engages in "commercial activity . . . in the United States," an exception to sovereign immunity applies.  Citing Intel Corp. v. Commonwealth Sci. & Indus. Research Org., 455 F.3d 1364, 1370 (Fed. Cir. 2006), the Court further noted that a defendant's "acts of (1) obtaining a United States patent and then (2) enforcing its patent so it could reap the profits thereof—whether by threatening litigation or by proffering licenses to putative infringers—certainly" are commercial activity.

In response to Appellants' argument that the University was presumptively immune from the jurisdiction of U.S. courts under the FSIA because the District Court erred in finding that the commercial activity exception under the FSIA applied to the University's immunity, the Federal Circuit explained that "[t]he University cannot claim immunity in the District Court because it obtained a U.S. patent and then participated in licensing and enforcing the '114 patent, which constitutes 'commercial activity' under the FSIA."  The Court also explained that "it matters not to [the Court's] analysis that it was LABOKLIN that physically wrote and sent the cease-and-desist letter to PPG, because the University conceded that it still retained substantial rights in the patent, such that the University, as the sole 'patentee,' ultimately controlled enforcement of the '114 patent."  The Federal Circuit therefore determined that the commercial activity exception to sovereign immunity applied such that the District Court properly exercised subject-matter jurisdiction over the University pursuant to § 1605(a).

On the issue of patent eligibility, LABOKLIN and the University argued on appeal that the asserted claims are directed to a patent-eligible application of the discovery of the underlying natural phenomenon because the asserted claims claim a man-made laboratory procedure.  The Federal Circuit, however, disagreed with Appellants' argument.

The Federal Circuit began its patent eligibility analysis by briefly reviewing four of its previous decisions:  Ariosa Diagnostics, Inc. v. Sequenom, Inc.; In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation; Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals International Ltd.; and Natural Alternatives International, Inc. v. Creative Compounds, LLC.  The Court then declared that "[h]ere, the Asserted Claims are not directed to a new and useful method for discovery because they begin and end with the point discovery of the HNPK mutation in the SUV39H2 gene," adding that:

[C]laim 1 simply states that the search for the mutation involves the laboratory examination of Labrador Retriever DNA, which resulted in the revelation of the mutation.  The mutation location itself and the fact that it is inherited through male and female dog carriers mating are both natural phenomena.

Noting that "the plain language of claim 1 demonstrates that it is directed to nothing more than 'observing or identifying' the natural phenomenon of a mutation in the SUV39H2 gene," the Court determined that "the Asserted Claims are directed to natural phenomenon at Alice step one."

The Federal Circuit also disagreed with Appellants' argument that the claimed methods apply a new discovery of the SUV39H2 gene and develop novel genotyping methods for Labrador Retrievers, finding instead that "[n]othing in claim 1's language suggests the invention of a new method for genotyping."  In affirming the District Court's finding of patent ineligibility, the Federal Circuit determined that "the Asserted Claims provide no tangible result save the observation and detection of a mutation in a dog's DNA."  So, while such discovery constituted "a positive and valuable contribution," the Federal Circuit found that "these claims fall short of statutory patentable subject matter."

Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH (Fed. Cir. 2019)
Panel: Circuit Judges Wallach, Hughes, and Stoll
Opinion by Circuit Judge Wallach

Ubisoft Entertainment, S.A. v. Yousician Oy (E.D.N.C.)

By James Korenchan --

In August 2018, Plaintiffs Ubisoft Entertainment, S.A. and Ubisoft, Inc. (collectively, "Ubisoft") sued Defendant Yousician Oy ("Yousician"), alleging that Yousician's software products infringed Ubisoft's U.S. Patent No. 9,839,852 (the '852 patent).  In November 2018, Yousician moved to dismiss on grounds that the claims of the patent are directed to patent-ineligible subject matter under 35 U.S.C. § 101.  On August 9, 2019, Judge Louise W. Flanagan of the U.S. District Court for the Eastern District of North Carolina granted the motion and dismissed Ubisoft's complaint.

The '852 patent is generally related to Ubisoft's music video game, Rocksmith®, which is an interactive game designed to help users learn how to play guitar, such as by allowing users to play guitar along with visual learning aids displayed on a screen and providing users with useful feedback and statistics based on their performance.  More particularly, the claims of the '852 patent relate to a computer program that receives signals from a guitar device while a user is playing a song, assesses the user's performance  of the song, and determines a portion of the song where the user can improve the performance.  Once the program determines where the user can improve, the program changes a difficulty level of the fingering notations for the determined portion of the song (e.g., changing a frequency or speed at which the notations are presented) and generates a "mini-game" targeted to improving the user's performance of the determined portion.  As an example, the mini-game might prompt the user to play the determined portion (or the entire song) without missing a note or without the aid of the displayed fingering notations.

Claim 1 is provided as follows as a representative example:

1.  A non-transitory computer readable storage medium with a computer program stored thereon, wherein the computer program is operable to present an interactive game for playing a song on a guitar, wherein the computer program instructs one or more processors to perform the steps of:
    presenting, on a display device, a plurality of fingering notations corresponding to the song to be played by a user;
    receiving, from a guitar input device, an analog or digital audio signal when the guitar is played by the user, wherein the received signal corresponds to the song played by the user;
    assessing a performance of the song as played by the user, based on the assessed performance, determining a portion of the performance that should be improved;
    based on the assessed performance and the determined portion of the performance that should be improved, selectively changing a difficulty level of at least a portion of the presented plurality of fingering notations corresponding to the song; and
    generating at least one mini-game different from the game for the song being played targeted to improving the user's skills associated with the performance of the determined portion.

The '852 patent criticizes conventional techniques (e.g., CDs, video tapes, music teachers/books) for learning how to play musical instruments as limited in their quality of instruction and the manners in which they present information.  As such, the '852 patent purports to improve on existing techniques with an "interactive method and system" that provides an integrated learning approach as well as audio and visual feedback.  Specifically, Ubisoft alleges that the claimed invention improves over the prior art by assessing a user's performance for improvement, selectively changing the difficulty level of the song based on the assessment, and generating a different game target to improve the user's skills based on the assessment.

Abstract Idea

Regarding step one of the Alice test, the Court asserted that the '852 patent is directed toward the abstract idea of teaching guitar by evaluating a user's performance and generating appropriate exercises to improve that performance.  According to the Court, a "typical music teacher" performs the steps of claim 1 when teaching a musical instrument.

In reaching its abstract idea conclusion, the Court found the Federal Circuit's 2016 decision in Apple Inc. v. Ameranth, Inc. to be instructive.  The patents in Ameranth were related to a computerized menu for ordering food.  The Federal Circuit struck down the claims of those patents as patent ineligible, asserting that the claims did not involve a way of programming or designing the software to create menus, but instead "merely claim[ed] the resulting systems" for a practice that has historically been done verbally.

Here, the Court asserted that the '852 patent merely claims the resulting systems for evaluating a user's performance and generating appropriate exercises.  More particularly, the Court asserted that the '852 patent merely adds a computer to well-established, real world activities that have been historically performed by music teachers and does not claim or describe details as to how the video game software assesses the user's performance, targets a particular portion of the performance, and generates a mini-game targeted towards improving the user's skill with regard to that portion.  Without such details, the Court found the claims to be more akin to those in Electric Power Group -- namely, those directed to "collecting information, analyzing it, and displaying certain results of the collection and analysis" without a claimed technological improvement.  And, to explain why no technological improvement was present, the Court cited to the '852 patent's specification:

[T]he '852 patent's specification does not describe an improvement regarding operating computers and states instead "[t]he invention may be applied as a standalone game engine system or as a component of an integrated software solution," and that "the processes presented herein are not inherently related to any particular computer, processing device, article or other apparatus."

The Court thus concluded that the claims are directed toward an abstract idea.

Inventive Concept

Turning to step two of the Alice test, the Court found no additional element or combination of elements in the claims that elevated the claim beyond, in its view, wholly generic computer implementation of established teaching methods.  The Court highlighted what it believed to be the "only arguable inventive concept" in the claims:  the limitation of changing the difficulty level of a song responsive to the assessment of the user's performance, such as in real time while the song is being played.  Indeed, Ubisoft had argued that a human music teacher cannot selectively change a difficulty level of the same song that the user was playing in the manner recited by the claims.  But after further examination, the Court ultimately found the concept to be "vague and lacking innovation" in the sense that the claims and specification did not explain how the difficulty level feature (and, likewise, the targeted mini-game generation feature) would be accomplished in a level of detail beyond what a music teacher would normally do (e.g., changing a frequency or speed of the presented fingering notations, breaking the song into sections having different difficulties).

Ubisoft also argued that the dependent claims of the '852 patent further emphasize the improvements that the claimed invention provides to existing approaches, but the Court dismissed the claims as substituting a generic computer for a human teacher, instead distinguishing them from the types of improvements to computer technology identified by the Federal Circuit over the past three years in Ancora Techs., Inc. v. HTC Am., Inc.; Enfish, LLC v. Microsoft Corp.; Data Engine Techs LLC v. Google LLC; and others.  Ubisoft also found no help in the prosecution history of the '852 patent, as the Court paid no heed to the Examiner's previous decision of patent eligibility and noted that the mini-game generation feature -- the one feature the Examiner hadn't found in the prior art -- was not a technological improvement or an advance in computer function.

Lastly, the Court dismissed Ubisoft's arguments that Yousician failed to prove that the recited steps in the claims are well-understood, routine, and conventional.

Thus, the Court concluded that the claims were patent-ineligible and granted Yousician's motion to dismiss.

Ubisoft Entertainment, S.A. v. Yousician Oy (E.D.N.C.)
Order by District Judge Louise W. Flanagan

ChargePoint, Inc. v. SemaConnect, Inc. (Fed. Cir. 2019)

By Michael Borella --

On July 23, 2019, the Federal Circuit denied ChargePoint's request for panel rehearing and en banc review of its March 28, 2019 decision rendering four ChargePoint patents invalid under 35 U.S.C. § 101.  Since we did not review this case when the panel decision came down, and because the case subsequently garnered attention as being one of the more problematic § 101 decisions of late, today we provide a review and some perspective of the substantive issues at hand.

ChargePoint sued SemaConnect in the District of Maryland, asserting infringement of U.S. Patent Nos. 8,138,715, 8,432,131, 8,450,967, and 7,956,570.  All four patents share the same specification.  SemaConnect moved for dismissal under Rule 12(b)(6) on the grounds that the patents failed to meet the eligibility requirements of § 101.  The District Court sided with SemaConnect.  ChargePoint appealed.

2014's Alice Corp. vs. CLS Bank Int'l Supreme Court case set forth a two-part test to determine whether claims are eligible for patenting under § 101.  One must first decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion.  But elements or combinations of elements that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle.  While this inquiry is generally carried out as a matter of law, factual issues can come into play when determining whether something is well-understood, routine, and conventional.

As described by the Court, the focus of the claimed inventions is "charging stations for electric vehicles."  Traditionally, charging was a long, slow, one-way process that required parking overnight or for a long period of time.  ChargePoint's technology purported to solve two semi-related problems with this charging.  First, allowing restaurants, shopping centers, or apartment complexes to control access to vehicle chargers on their premises.  Second, allowing electric vehicles to transfer power to the electrical grid in times of high demand on the grid.  In the words of the Court:

ChargePoint contends that its inventors created improved charging stations that address the various needs inherent in electric vehicle charging.  This was accomplished by creating networked charging stations.  According to ChargePoint, this network connectivity allows the stations to be managed from a central location, allows drivers to locate charging stations in advance, and allows all users to interact intelligently with the electricity grid.

Claims 1 and 2 of the '715 patent recite:

1.  An apparatus, comprising:
    a control device to turn electric supply on and off to enable and disable charge transfer for electric vehicles;
    a transceiver to communicate requests for charge transfer with a remote server and receive communications from the remote server via a data control unit that is connected to the remote server through a wide area network; and
    a controller, coupled with the control device and the transceiver, to cause the control device to turn the electric supply on based on communication from the remote server.

2.  The apparatus of claim 1, further comprising an electrical coupler to make a connection with an electric vehicle, wherein the control device is to turn electric supply on and off by switching the electric coupler on and off.

In addressing procedural aspects of the § 101 inquiry, the Court noted that "we have found the specification helpful in illuminating what a claim is 'directed to.'"  On the other hand, "while the specification may help illuminate the true focus of a claim, when analyzing patent eligibility, reliance on the specification must always yield to the claim language in identifying that focus."

With that in mind, the Court rapidly concluded that "[i]t is clear from the language of claim 1 that the claim involves an abstract idea—namely, the abstract idea of communicating requests to a remote server and receiving communications from that server, i.e., communication over a network."  But this was insufficient to determine whether the focus of the claim was an abstract idea.  So the Court continued by looking to the specification to understand the problem being solved by the inventors.

Reviewing its own precedent, the Court observed that statements made by the inventors in the specification can be used to determine this focus.  But hardware components described only at a high level of detail or functionally are generally outside of this focus.

The problem facing the inventors, according to the Court, was "the lack of a communication network that would allow drivers, businesses, and utility companies to interact efficiently with the charging stations."  "From these statements," the Court concluded, "it is clear that the problem perceived by the patentee was a lack of a communication network for these charging stations, which limited the ability to efficiently operate them from a business perspective."  To further justify its interpretation, the Court observed that "the specification never suggests that the charging station itself is improved from a technical perspective, or that it would operate differently than it otherwise could . . . [n]or does the specification suggest that the invention involved overcoming some sort of technical difficulty in adding networking capability to the charging stations."  Thus, "the specification suggests that the invention of the patent is nothing more than the abstract idea of communication over a network for interacting with a device, applied to the context of electric vehicle charging stations."

After establishing the problem to be solved, the Court turned to the language of the claims and found that it would "preempt the use of any networked charging stations."  The Court indicated that the breadth of the claims dictated such an expansive preemption, as the claims would effectively cover all solutions for achieving a desired result.

To sum up the analysis of claim 1:

In short, the inventors here had the good idea to add networking capabilities to existing charging stations to facilitate various business interactions.  But that is where they stopped, and that is all they patented.  We therefore hold that claim 1 is "directed to" an abstract idea.

The Court shot down claim 2 on similar grounds, finding that the limitation of an "electrical coupler to make a connection with an electric vehicle" does not change the nature of the invention being claimed.  Thus, both claims are directed to an abstract idea.

The Court applied a similar analysis to the claims of the other patents and came to the same outcome.  Indeed, the Court made the dangerously sweeping statement that "[c]ommunication over a network for [the purpose of device interaction] has been and continues to be a building block of the modern economy" -- an abstract idea.  Undoubtedly, these words will be quoted over and over in future district court and Federal Circuit litigation in attempts to establish that any invention involving networked communication is per se ineligible under § 101.  Patent professionals are sadly shaking their heads at this all-too-likely and probably unintended consequence.

In any event, the Court moved on to part two of the Alice test.  ChargePoint contended that it has presented factual allegations that, under Berkheimer v. HP, would preclude a Rule 12(b)(6) dismissal.  These included purported unconventional approaches involving "(a) the ability to turn electric supply on based on communications from a remote server; (b) a network-controlled charging system; and (c) a charging station that receives communication from a remote server, including communications made to implement a demand response policy."

The Court's response -- unfortunately predictable at this point -- was that these innovations were directed to network control, which is the abstract idea itself.  To that end, the Court noted that "a claimed invention's use of the ineligible concept to which it is directed cannot supply the inventive concept that renders the invention 'significantly more' than that ineligible concept."

The Court wrapped up:

ChargePoint, of course, disagrees with this characterization, arguing that its patents claim "charging stations enabled to use networks, not the network connectivity itself."  But the specification gives no indication that the patented invention involved how to add network connectivity to these charging stations in an unconventional way.  From the claims and the specification, it is clear that network communication is the only possible inventive concept.  Because this is the abstract idea itself, this cannot supply the inventive concept at step two.

Thus, the claims were ruled ineligible under § 101 and invalidated accordingly.

Yes, the claims were broad.  Yes, they were vague, and the specification probably didn't describe the invention as well as it should have.  But for the 5,000th time, we have more well-founded and objective tests for these issues in §§ 102, 103, and 112.  Lumping obviousness and written description into § 101 results in the skewed analysis that you see here and in other eligibility decisions.

And the outcome herein is indicative of the hazard associated with applying a variation of the "technical solution to a technical problem" test.  Sure, such a test has been used in Europe and other jurisdictions for quite some time.  But it is being used differently here (i.e., the problem and state of the art are based on statements in the specification rather than prior art, and the test is separate from the obviousness analysis).  As a result, the Federal Circuit is shooting more holes in the long-standing principle that the invention is defined by the claims.  Instead, the invention is now defined by a subjective evaluation of what a judge believes to be the problem being solved, and then this identified problem is used to color the interpretation of the claims under § 101.  If the problem is viewed as non-technical, then the claims can easily be found abstract, as was the case with ChargePoint.  The fact that the Federal Circuit has previously found claims that solve business problems to be eligible under § 101 (e.g., DDR Holdings v. Hotels.com) seems to be beside the point.

The ensuing cognitive dissonance -- ChargePoint's device-oriented claims being viewed as abstract -- illustrates the judicial-exception-creep that has been occurring since Alice.  Since the § 101 inquiry can be applied in an outcome oriented fashion, more and more non-abstract devices, systems, structures, and components are now being lumped into the abstract idea classification or ignored as "conventional" in part two of the Alice test.  The abstract idea exception is a legal fiction that has been expanded to the point of meaninglessness -- thinking about network communication is truly abstract, but actual network communication or the facilitation thereof is not.

Indeed, the language of the claims matter little when one can try to infer from the specification what the claims "really mean" and then analyze that ascribed meaning rather than what the claims actually recite.  The door is left open for bad actors to try to convince the judiciary that virtually everything involving a computer, software, or a network is abstract.  At what point do we realize that, as just one example, the little computers we carry around in our pockets use software in a tangible fashion to communicate and have a concrete impact on themselves and other devices?  At what point does the legal fiction of the abstract idea swallow all of patent law?  Hint: this case.

ChargePoint Inc. v. SemaConnect Inc. (Fed. Cir. 2019)
Per Curiam

The PTAB Goes to Europe: Four Recent Section 101 Decisions Designated as Informative

By Michael Borella --

On July 1, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) designated four of its recent 35 U.S.C. § 101 decisions as informative.  Each of these decisions came down after and applied the USPTO's 2019 Revised Patent Subject Matter Eligibility Guidance.  Two resulted in claims being found eligible, and two had the opposite outcome.  While not binding on other PTAB panels or examiners, these cases are helpful in understanding how the PTAB is applying the Guidance.  In particular, the PTAB appears to be utilizing the Guidance in a fashion that is similar to how the subject matter eligibility inquiry is employed in the European Patent Office and certain other jurisdictions -- as consideration of whether the claimed invention is a technical solution to a technical problem.

The background of these decisions -- not to mention the Guidance itself -- is 2014's Alice Corp. vs. CLS Bank Int'l Supreme Court holding.  Therein, the Court set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101.  One must first decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion.  But elements or combinations of elements that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle.  While this inquiry is generally carried out as a matter of law, factual issues can come into play when determining whether something is well-understood, routine, and conventional.

Notably, the Guidance breaks the first part of the Alice test into two sub-steps.  In the former, one determines whether the claim recites a judicial exception, such as an abstract idea.  In the latter, one determines further "whether the recited judicial exception is integrated into a practical application of that exception."  To focus the analysis, the Guidance indicates that all abstract ideas should fall into one of three categories:  mathematical concepts, certain methods of organizing human activity, and mental processes.  Think of these as the "Three M's" – math, money, and mental steps.

And now, on to the cases.

Ex Parte Fautz (U.S. Patent App. No. 14/326,661)

The claimed invention "generally relates to magnetic resonance (MR) tomography."  An MR device "use[s] reception coils to receive signals generated while scanning a subject," and the "invention optimizes the signal-to-noise ratio (SNR) from the reception coils."  The PTAB focused its review on representative claim 8:

The Examiner rejected the claim under § 101, finding it "similar to abstract ideas relating to mathematical formulas and collecting information, analyzing it, and displaying certain results of the collection and analysis."  The Examiner further found that "the MR tomography apparatus is an additional element that is well-understood, routine, and conventional in the art," while the "data collection and display are insignificant extra-solution activity."

The PTAB disagreed.  Applying the Guidance, the PTAB quickly concluded that under the first part of Alice, the claim recites an abstract idea -- notably three distinct mathematical formulas.  Continuing the inquiry, the PTAB then determined that the claim nonetheless integrates this abstract idea into a practical application thereof. 

The PTAB found the claim to be similar in nature to that of Thales Visionix, Inc. v. United States, where mathematical concepts were used to solve a technical problem and that the recited device "is neither a token addition nor an abstract concept."  To come to this conclusion, the PTAB looked to the application's specification which pointed out drawbacks to existing surface coils in MR systems -- these coils can result in poor image quality.  But, as described in the specification, the claimed invention improves the sensitivity of the coils, and thereby also improves image quality.

Accordingly, the PTAB concluded that the claim is not directed to an abstract idea, is eligible, and that the second part of the Alice test need not be considered.

Ex Parte Olson (U.S. Patent App. No. 11/715,923)

This second case involves a "locally deformable registration of a catheter navigation system to an external model or external image data such that the invention operates to transform the coordinate system of a catheter navigation system to the coordinate system of an external model or external image data."  Representative claim 7 recites:

The Examiner found the claim abstract because it "relies upon collecting and comparing known information, comparing new and stored information and using rules to identify options, organizing information through mathematical correlations, which are considered an abstract idea."  The Examiner further found that the claimed algorithm, the computer on which it runs, and the catheter navigation system, to all be generic.  The Examiner also stated that "Appellants do not claim any new and novel structures for the catheter and catheter navigation system."  Turning to part two of the Alice test, the Examiner found all of the additional elements to be well-known and conventional.

On appeal, the PTAB quickly determined that, through its explicit use of equations, the claim recites an abstract idea -- particularly, a mathematical concept.  But like Ex Parte Fautz, this abstract idea is integrated into a practical application.

To that point, the PTAB observed that the claim focuses on "addressing problems arising in the context of registering a catheter navigation system to a three-dimensional image in connection with cardiac procedures."  Further, the limitations therein "apply the recited mathematical calculations to improve registration of a catheter navigation system to a three-dimensional image of a heart by accounting for non-linearities and inhomogeneities in the catheter navigation system and reduce errors in the localization field."  Looking again to the specification, the PTAB noted that the invention provides a technical improvement of "avoid[ing] errors introduced in the prior art, such as those introduced when an affine transformation is used."  The PTAB also found the claims to be analogous to those of Thales and Diamond v. Diehr, and that the mathematical concepts were applied to a particular machine -- the catheter navigation system.

Thus, the PTAB concluded that the claim is not directed to an abstract idea, is eligible, and again declined to apply the second part of the Alice test.

Ex Parte Kimizuka (U.S. Patent App. No. 13/871,055)

The claimed invention involves software for selecting a golf club with a suitable lift angle for a player based on data from hit balls.  According to this application's specification, "[a] club's loft angle relates to the orientation of its face and influences a hit ball's flight distance."  Claim 7, which was deemed representative, recites:

A fitting method of a golf club, comprising the following steps of:
    creating a hit ball result database based on ball initial velocity prediction data, launch angle prediction data, and back spin prediction data, the ball initial velocity prediction data being data capable of predicting a ball initial velocity based on the dynamic loft and the blow angle, the launch angle prediction data being data capable of predicting a launch angle based on the dynamic loft and the blow angle, and the backspin prediction data being data capable of predicting a backspin based on the dynamic loft and the blow angle, wherein the hit ball result database is obtained by actual measurement and/or a simulation;
    measuring a subject's head speed, dynamic loft, and blow angle using a reference club;
    determining, by a processor, a suitable dynamic loft based on only the measured head speed, the measured dynamic loft, and the measured blow angle, the suitable dynamic loft being defined as a dynamic loft achieving a predetermined hit ball result, wherein the hit ball result database is used for determining the suitable dynamic loft, the hit ball result database includes correlation data between the dynamic loft and the blow angle which are created for each head speed, and the hit ball results in the dynamic lofts in the measured blow angle are compared using the hit ball result database;
    determining a dynamic loft difference from the suitable dynamic loft and the measured dynamic loft; and
    determining a recommended loft angle based on a loft angle of the reference club and the dynamic loft difference, wherein the hit ball result includes a flight distance.

The Examiner rapidly disposed of this claim, finding it directed to an abstract mental process, with all additional elements being well-understood, routine, and conventional.  The PTAB generally agreed.

The PTAB began by stating that, under broadest reasonable interpretation, the claimed steps could be performed in the mind (the Guidance allows one to ignore general hardware -- such as the claimed processor -- when making this determination).  Thus, the PTAB concluded that the claim recites an abstract idea.

Turning to the next step in the Alice part one inquiry, the PTAB considered whether the claim involves an improvement to a technology or technical field.  The PTAB found that the golf club selection was a non-technical problem.  Notably, the claim did not "improve how the measurements are taken or improve how the golf club is manufactured."  The PTAB then reviewed the additional elements individually, finding that each is either a token element, is used for its intended purpose (and therefore is not improved), or embodies insignificant data collection.  Therefore, the claim was found to be directed to an abstract idea under part one of the Alice test.

Applying part two (which is effectively quite similar to the second half of part one), the PTAB sought to determine whether the additional elements were just well-understood, routine, and conventional in the field.  Indeed, the processor, database, and measurements (alone and in combination) were considered to fit this bill based on reasoning similar to why they failed to integrate the claimed abstract idea into a practical implementation.

Consequently the claim was deemed ineligible and the Examiner was affirmed.

Ex Parte Savescu (U.S. Patent App. No. 12/468,616)

Here, the claimed invention relates to software for creating "a life-cycle workflow for a project."  Representative claim 1 recites:

A method for creating a life cycle workflow for a project comprising:
    creating one or more identifiable workflow stages for the project on a server computer, each of the one or more workflow stages corresponding to a specific sequence of workflow activities, wherein the creating further comprises using a workflow stage identifier as a property of the specific sequence of workflow activities for each of the one or more workflow stages;
    creating one or more identifiable workflow phases for the project on the server computer, each workflow phase includes one or more corresponding workflow stages;
    creating one or more project detail pages on the server computer, each project detail page being a web page that is made visible during a corresponding workflow stage;
    when a workflow stage is created, associating a workflow phase with the workflow stage, the workflow phase being selected from the one or more workflow phases on the server computer; and
    when the workflow stage is created, associating one or more project detail pages for the workflow stage.

The Examiner rejected the claim as being directed to an abstract idea without any additional elements that amount to significantly more than that idea.  The PTAB affirmed the Examiner's rejections.

Applying the Guidance, the PTAB pointed to the business nature of the claim ("determining a project name, describing the project's purpose, defining a project's scope, among other things") as indicative of "a concept related to managing relationships or transactions between people."  As such, the PTAB concluded that the claim recited certain methods of organizing human activity, one of the three categories of abstract ideas set forth in the Guidance.

Moving on the next phase of the first part of the Alice test, the PTAB identified the claimed server and the step of "creating one or more project detail pages on the server computer, each project detail page being a web page that is made visible during a corresponding workflow stage" as the additional elements.  The PTAB found that the server was a generic computer, while the creation of project detail pages did not involve a technical improvement to how those pages were created.  The PTAB also found that, at best, the claim automated a process that could have been carried out manually.  All of this added up to a failure of the claim to integrate the abstract idea into a practical application.

Turning to part two of the Alice test, the PTAB looked to the additional elements again and found them to be well-understood, routine, and conventional features.  Therefore, the claim did not provide an inventive concept, and was determined to be ineligible.

Analysis

There are a few lines of reasoning running through these four cases that are worth pointing out.  For the two that were found meet the requirements of § 101, the claims therein are narrowly focused and provide a technical solution to a technical problem.  For each, the technical problem and technical solution were described in the specification, and explicitly reflected in the claim language.  On the other hand, for the two cases that failed the Alice test, the PTAB specifically stated that the claims were not addressing technical problems, and were broadly drafted.

This suggests that the PTAB may be following a variant of the European view that eligible subject matter must be directed to a technical solution to a technical problem.  If so, that is problematic because there is no requirement in U.S. patent law that § 101 be applied so rigidly.  In fact, the Federal Circuit found the claims in DDR Holdings v. Hotels.com to be eligible despite their being focused on a technical solution to a business (non-technical) problem.

Furthermore, a post-hoc evaluation of whether a claim is addressing a "technical" problem can be subjective.  For example, an invention that provides real-time updating of graphical user interfaces that display data about service-level agreement compliance can be viewed as addressing a technical problem (real-time updating of the interfaces) or a non-technical problem (evaluating contractual conformity).

In any event, these four cases may help applicants determine whether a § 101 appeal to the PTAB makes sense.  If your claims fall into the technical solution to a technical problem camp, then an appeal may be viable.  Otherwise, you might be best off working a bit longer with the examiner.

The Proper Role of the Federal Circuit

By Kevin E. Noonan --

There has been much commentary, some of it incendiary, regarding whether the Court of Appeals for the Federal Circuit is fulfilling its responsibilities under its enabling statute or failing to provide the proper pro-patent perspective in its response and implantation of the Supreme Court's jurisprudence regarding subject matter eligibility under 35 U.S.C. § 101.  The problem is illustrated by the comments provided by two members of the Court, Judges Lourie and O'Malley, in their concurrence and dissent, respectively, with the Court's per curiam denial of en banc review in Athena Diagnostics Inc. v. Mayo Collaborative Services, LLC.

Judge Lourie voices the view, first enunciated by Judge Linn in Ariosa Diagnostics, Inc. v. Sequenom, Inc., that as an inferior appellate court, its hands are tied by the Supreme Court's decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Alice Corp. Pty. Ltd. v. CLS Bank Int'l, and Association for Molecular Pathology v. Myriad Genetics, Inc.:

If I could write on a clean slate, I would write as an exception to patent eligibility, as respects natural laws, only claims directed to the natural law itself, e.g., E=mc2, F=ma, Boyle's Law, Maxwell's Equations, etc.  I would not exclude uses or detection of natural laws.  The laws of anticipation, obviousness, indefiniteness, and written description provide other filters to determine what is patentable.  . . .  But we do not write here on a clean slate; we are bound by Supreme Court precedent.

This view is apparently shared by seven of the Court's twelve members.  Judge O'Malley enunciates the countervailing view regarding what the Court should do to change this state of affairs, stating her opinion that the Court has gone astray in slavishly and too stringently applying the Supreme Court's precedent to unnecessarily restrict the scope of what is eligible (particularly with regard to diagnostic method claims, including the ones at issue before the Court in Athena):

I agree with all my dissenting colleagues that our precedent applies the Supreme Court's holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) too broadly.  I write separately, however, because I believe that confusion and disagreements over patent eligibility have been engendered by the fact that the Supreme Court has ignored Congress's direction to the courts to apply 35 U.S.C. sections 101, et seq ("Patent Act") as written.  Specifically, the Supreme Court has instructed federal courts to read into Section 101 an "inventive concept" requirement—a baffling standard that Congress removed when it amended the Patent Act in 1952.  I encourage Congress to amend the Patent Act once more to clarify that it meant what it said in 1952.

It is clear that Congress is the ultimate (or perhaps only) solution.  But if Judge O'Malley identifies the Federal Circuit's complicity in engendering the current situation, Judge Newman in dissent enumerates the Court's application of Supreme Court precedent to diagnostic method claims, all of these decisions invalidated the patents at issue:

1. In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014).  The claimed invention is a method for screening for genes linked to inherited breast and ovarian cancer, by analyzing for certain mutations in the DNA.  The court held the claims ineligible under section 101 as directed to a law of nature, and also held that identifying genetic mutations is an ineligible abstract idea.

2. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).  The claimed invention is a method for detecting paternally-inherited fetal abnormalities by analyzing the blood or serum of a pregnant female.  The court held the claims ineligible under section 101, while recognizing that "detecting cffDNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science."  Id. at 1380.

3. Genetic Technologies Ltd. v. Merial L.L.C., 818 F.3d 1369 (Fed. Cir. 2016).  The claimed invention is a method for detecting a coding region of DNA based on its relationship to non-coding regions, by amplifying genomic DNA with a primer spanning a non-coding sequence in genetic linkage to an allele to be detected.  The court stated that "the patent claim focuses on a newly discovered fact about human biology," id. at 1376, and that this is a law of nature and is ineligible subject matter under section 101.

4. Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017).  The claimed invention is a method for diagnosing risk of cardiovascular disease by analyzing for the enzyme myeloperoxidase ("MPO").  The court held that even though prior methods for detecting MPO were inferior, the discovery of how to directly analyze for MPO, and discovery of the relation to the risk of cardiovascular disease, although "groundbreaking, 'even such valuable contributions can fall short of statutory patentable subject matter.'"  Id. at 1363 (quoting Ariosa, 788 F.3d at 1380).

5. Roche Molecular Systems, Inc. v. CEPHEID, 905 F.3d 1363 (Fed. Cir. 2018).  The claimed invention is a method for detecting the pathogenic bacterium Mycobacterium tuberculosis ("MTB"), based on nucleotide content and a novel method of analysis.  The court stated that the method is new, unobvious, and "both faster and more accurate than the traditional MTB detection methods," id. at 1366, but held that the method is ineligible under section 101.

6. Cleveland Clinic Foundation v. True Health Diagnostics LLC, 760 F. App'x 1013 (Fed. Cir. 2019).  The claimed invention is the novel immunoassay to detect the correlation between blood MPO levels and cardiovascular disease.  The court held that the claims are for a law of nature and ineligible under section 101.

(Including Athena there are seven such cases.) (Conversely, as Judge Newman notes in her dissent, the Federal Circuit has repeatedly affirmed eligibility of "method of treatment" claims, in Rapid Litigation Management Ltd. v. CellzDirect, Inc.; Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd.; Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC; and Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.)

Both Judge Moore (writing in dissent) and Judge Chen (concurring) also recognize the problematic nature of the Court's jurisprudence on patent eligibility.  And each agree with Judge O'Malley that Congress alone can address the issue, Judge Moore stating that:

In the wake of Mayo, we have painted with a broad brush, suggesting that improved diagnostic techniques are not patent eligible.  Mayo did not go so far, and given the import of diagnostic techniques, we should reconsider this case and clarify our precedent.  Because my colleagues have declined to do so, there are no more options at this court for diagnostic patents.  My colleagues' refusal deflates the Amici's hopeful suggestion that our precedent leaves the eligibility of a diagnostic claim in front of the Federal Circuit "uncertain."  It is no longer uncertain.  Since Mayo, every diagnostic claim to come before this court has been held ineligible.  While we believe that such claims should be eligible for patent protection, the majority of this court has definitively concluded that the Supreme Court prevents us from so holding. No need to waste resources with additional en banc requests.

For those keeping score, it appears that all (or almost all) of the members of the Court believe that their patent eligibility cases have been wrongly decided.  Chief Judge Prost, joined by Judges Lourie, Dyk, Reyna, Hughes, Taranto, and Chen believe the Court's hands are tied by Supreme Court precedent, while Judges Newman, Moore, O'Malley, Wallach, and Stoll believe the Federal Circuit has the basis to distinguish Supreme precedent and hold these claims (or at least claims 7-9 of Athena's claims at issue) are patent eligible.

Judge O'Malley provides an additional avenue for Congressional intervention, related to the Supreme Court's resurrection of the "inventive concept" trope many believed was relegated to the dustbin of history by Section 103 in Giles Sutherland Rich's revision resulting in the 1952 Patent Act.  She provides an alternative to Senator Tillis' and Coons' proposed statutory abrogation of the judicial exceptions (which raises its own issues on Congressional authority and the Supreme Court's oversight on ultra vires legislative actions).  Judge O'Malley's suggestion is direct:

Had the Supreme Court not disregarded Congress's wishes for a second time [by introducing "inventive concept" into its Section 101 calculus], perhaps the outcome in this case would be different.  . . .  Indeed, claims directed to uses of natural laws rather than the natural laws themselves would be eligible under § 101 as written.  Because the Supreme Court judicially revived the invention requirement and continues to apply it despite express abrogation, I dissent to encourage Congress to clarify that there should be no such requirement read into § 101; to clarify that concepts of novelty and "invention" are to be assessed via application of other provisions of the Patent Act Congress designed for that purpose.

The issue for the Federal Circuit is not just that their views are so fractured, but that the dissension between the Judges regarding whether they should simply apply Supreme Court precedent (even incorrectly) until such time as the Supreme Court deign to address the issue, or whether their "special expertise" and Congressional mandate creates a responsibility to distinguish the Supreme Court's precedent when it does not properly apply, at least to provide incentive to the Supreme Court to provide (in its view) the correct interpretation of what is and what is not patent eligible.  In at least the view of five of the judges (and many in the patent bar) the Federal Circuit has failed in exercising it responsibility, to the extent that many openly speculate whether we need the Federal Circuit at all.

Yu v. Apple Inc. (N.D. Cal. 2019)

Patent Claims for Digital Camera Are Not Patent Eligible

By Joseph Herndon --

In two related actions in the U.S. District Court for the Northern District of California brought by Yanbin Yu and Zhongxuan Zhang (patentee), Apple Inc. and Samsung Electronics Co., Ltd. were sued for infringement of U.S. Patent No. 6,611,289, entitled "Digital Cameras Using Multiple Sensors with Multiple Lenses".  The dispute is over use of dual-lens cameras in cell phones.  Yu alleged that the dual-lens cameras in Apple and Samsung cell phones infringe the '289 patent.

Apple moved to dismiss for patent ineligibility under 35 U.S.C. § 101, and Samsung joined the motion.  In Defendants' view, the asserted claims cannot be patented because they "are directed to the abstract idea of creating an image by using one image to enhance another image," without any saving inventive concept.  The Court agreed and dismissed the complaints.

The '289 Patent

The '289 patent issued August 26, 2003, and is directed to improving digital photos that were said to lack resolution and dynamic color range of traditional film images.  The patent claims an invention of a digital camera capable of producing high resolution images with better colors and details in a greater range through an arrangement of multiple image sensors, lenses, and a processor to produce high quality and film-like true color digital images.

Claim 1 is representative and recites:

1.  An improved digital camera comprising:
    a first and second image sensor closely positioned with respect to a common plane, said second image sensor sensitive to a full region of visible color spectrum;
    two lenses, each being mounted in front of one of said two image sensors;
    said first image sensor producing a first image and said second image sensor producing a second image;
    an analog-to-digital converting circuitry coupled to said first and said second image sensor and digitizing said first and said second intensity images to produce correspondingly a first digital image and a second digital image;
    an image memory, coupled to said analog-to-digital converting circuitry, for storing said first digital image and said second digital image; and
    a digital image processor, coupled to said image memory and receiving said first digital image and said second digital image, producing a resultant digital image from said first digital image enhanced with said second digital image.

Patent Ineligibility under Section 101

For the merits of the Section 101 issue, the scope of patentable subject matter includes "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof."  35 U.S.C. § 101.  But, of course, abstract ideas are specific exceptions to § 101's broad patent-eligibility principles.  According to Alice, Courts must distinguish between patents that claim the building blocks' of human ingenuity and those that integrate the building blocks into something more, because overbroad patent protection would risk disproportionately tying up the use of the underlying ideas.

Applying the two-step analysis of Alice, the District Court first determined whether the claims at issue are directed to a patent-ineligible concept such as an abstract idea.

Claim 1 recites a digital camera, comprising "[1] a first and a second image sensor closely positioned with respect to a common plane . . . [2] two lenses . . . [3] said first image sensor producing a first image and said second image sensor producing a second image . . . [4] an analog-to-digital converting circuitry coupled to said first and said second image sensor . . . [5] an image memory . . . and [6] a digital image processor . . . producing a resultant digital image from said first digital image enhanced with said second digital image."

The Court concluded that this plain language makes clear that claim 1 is drawn to the abstract idea of taking two pictures and using those pictures to enhance each other in some way.  The Court stated that since the earliest years of the photographic medium, those having skill in the art have used multiple exposures, or the combining of multiple images, to enhance images.

From a patent attorney's viewpoint, however, if the issue is that it has been known for some time to use multiple exposures, surely that issue would be better addressed under 35 U.S.C. § 102 or 35 U.S.C. § 103 as a prior art issue, and not as a patent eligibility issue.  But I digress.

Next, the Court noted that the claims here are defined only in terms of their functions.  For support of this statement, the Court noted that the '289 patent does not require special hardware or software, but instead, describes that "there is a great need for a generic solution that makes digital cameras capable of producing high resolution images without enormously incurring the cost of photosensitive chips with multimillion photocells."

This is an odd statement by the Court, however, since the claim explicitly recites structure of the camera (e.g., a first and second image sensor closely positioned with respect to a common plane, . . . two lenses, each being mounted in front of one of said two image sensors), so the claim in fact is not "only" defined in terms of function.

The patentee attempted to equate Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017), to the present case.  Thales upheld a patent that dealt with an arrangement of sensors, and Yu contends the result should be the same here because the '289 patent similarly instructs a "particular configuration" of sensors.  The Court, however, found that Thales is distinguishable because its patent-in-suit stated why and how the "particular configuration" of sensors contributed to an advancement over the prior art.  In contrast, the only configuration to which "benefits and advantages" are attributed in the specification in the '289 patent is the mere use of multiple lenses and sensors.

The Court noted that the '289 patent expressly eschews any special hardware or software in favor of a "generic solution," and other components in the claim are described at a high level and lack detail (the analog-to-digital circuitry is described simply as "digitiz[ing] the output signals"; the image processor is described functionally as "[u]sing a set of digital image processes embedded in a digital signal processing chip, images . . . are processed . . . and subsequently produce high quality and film-like true color digital images.").

Thus, it would appear that the Court found the claim directed to an abstract idea due to lack of a detailed description having a technical effect.  This is generally a European requirement or standard, and is not a requirement in the U.S.  The claim clearly recites structure or a configuration of tangible components, and it would seem that the claim should have been found to have satisfied step 1.

Since the Court found the patent to be directed to a patent-ineligible concept under step 1, the Court turned to the second step in Alice to look for an "'inventive concept'—i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself."

The Court found that there were no allegations that the asserted combination and arrangement of "well-understood, routine and conventional" digital camera components goes beyond the abstract idea of using multiple images to enhance one image.  The Court stated that once the abstract idea is removed from the claim, all that is left here is the "conventional technology" of a digital camera, such as image sensors, lenses, circuitry, memory, and a processor being used in conventional ways.

Thus, the Court found that because the '289 patent is directed to an abstract idea and does not add an inventive concept, the patent was directed to ineligible patent subject matter and the complaints were dismissed.  Since the motion was decided at this early stage, the Court dismissed the complaints with leave to file amended complaints with more detail.

Yu v. Apple Inc. (N.D. Cal. 2019)
Order Re Motion to Dismiss by District Judge Donato

Athena Diagnostics v. Mayo Collaborative Services -- The Dissents

By Donald Zuhn --

On July 3, the Federal Circuit issued a per curiam Order in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, denying a petition for rehearing en banc filed by Plaintiffs-Appellants Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V.  The Court also denied Plaintiffs-Appellants a panel rehearing.

The four page per curiam Order was accompanied by eight opinions, four concurring in the denial of the petition and four dissenting in the denial of the petition, adding an additional 82 pages to the Order.  The four concurring opinions were authored by Circuit Judges Lourie, Hughes, Dyk, and Chen, with Chief Judge Prost and Circuit Judges Reyna, Taranto, and Hughes joining in one of the concurrences and Circuit Judge Chen joining in one concurrence and several parts of another.  The four dissenting opinions were authored by Circuit Judges Moore, Newman, Stoll, and O'Malley, with Circuit Judges O'Malley and Stoll joining in one of the dissents and Circuit Judge Wallach joining in three of the dissents.  Thus, a total of seven members of the Court (Chief Judge Prost and Circuit Judges Lourie, Dyk, Reyna, Taranto, Chen, and Hughes) authored or joined opinions concurring in the denial, and a total of five members (Circuit Judges Newman, Moore, O'Malley, Wallach, and Stoll) authored or joined opinions dissenting in the denial.

Last week, we reviewed the procedural history of the case and provided a brief summary of the eight concurring and dissenting opinions (see "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)").  On Sunday, we reviewed the four opinions concurring in the Order's denial of the petition for rehearing en banc (see "Athena Diagnostics v. Mayo Collaborative Services -- The Concurrences").  In this post, we focus more closely on the four opinions dissenting in the Order's denial of the petition for rehearing en banc.  As we noted last week, several of the dissenting authors disagreed with the concurring authors that Mayo compelled a finding of patent ineligibility in this case.

In the first dissent (which at just over twenty-two pages is the longest of the four dissents), Judge Moore, joined by Judges O'Malley, Wallach, and Stoll, disagrees with the majority of her colleagues that "believe that our hands are tied and that Mayo requires this outcome," indicating instead that "[t]he claims in this case should be held eligible, and they are distinguishable from Mayo."  Judge Moore contends that the Court "should reconsider this case and clarify our precedent."

Judge Moore begins her opinion by noting that:

This is not a case in which the judges of this court disagree over whether diagnostic claims, like those at issue in Athena, should be eligible for patent protection.  They should.  None of my colleagues defend the conclusion that claims to diagnostic kits and diagnostic techniques, like those at issue, should be ineligible.  The only difference among us is whether the Supreme Court's Mayo decision requires this outcome.  The majority of my colleagues believe that our hands are tied and that Mayo requires this outcome.  I believe Mayo does not.

Citing Cleveland Clinic Found. v. True Health Diagnostics LLC (Fed. Cir. 2019) ("Cleveland Clinic II"); Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC (Fed. Cir. 2019); Roche Molecular Sys., Inc. v. CEPHEID (Fed. Cir. 2018); Cleveland Clinic Found. v. True Health Diagnostics LLC (Fed. Cir. 2017) ("Cleveland Clinic I"); Genetic Techs. Ltd. v. Merial L.L.C. (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015); In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litig. (Fed. Cir. 2014); and PerkinElmer, Inc. v. Intema Ltd. (Fed. Cir. 2012), Judge Moore notes that "[s]ince Mayo, we have held every single diagnostic claim in every case before us ineligible," concluding that "[w]e have turned Mayo into a per se rule that diagnostic kits and techniques are ineligible."  According to Judge Moore, the per se rule is a result of the Federal Circuit's "fervor for clarity and consistency."  However, she does not fault her colleagues, "who under protest have concluded that they have no choice but to hold the claims in Athena ineligible because of Mayo," explaining that:

There is surely some broad language in Mayo which could lead to this conclusion.  I, however, think we have extended Mayo too far.  Reading the entirety of Mayo and the subsequent Myriad decision, the Supreme Court did not intend Mayo to be the "sweeping" decision my colleagues have concluded it is.

Nevertheless, her opinion calls of the members of the Court "to rethink our interpretation of Mayo."

In the second part of her opinion, Judge Moore asserts that "diagnostic techniques and kits when narrowly claimed are precisely the type of innovation the patent system exists to promote," pointing out that "[t]he importance of diagnostics and their cost-reducing effects on patient treatment cannot reasonably be questioned."  She contends that "when there are specific advances, discoveries, or inventions in the diagnostics industry, they must be eligible for patent protection," explaining that:

Unless one opposes the notion of patent protection entirely, it cannot be reasonably disputed that claims to diagnostic kits and techniques, like pharmaceuticals, which require enormous initial investments in terms of both time and money, are the reason we suffer the promise of a monopoly.  As many have explained, without patent protection, there will be little incentive for companies to invest the monumental amount of time and money necessary to develop diagnostic kits, tools and techniques.

Judge Moore concludes the second part of her opinion by stating that:

The math is simple, you need not be an economist to get it:  Without patent protection to recoup the enormous R&D cost, investment in diagnostic medicine will decline.  To put it simply, this is bad.  It is bad for the health of the American people and the health of the American economy.  And it is avoidable depending on our interpretation of the Supreme Court’s holding in Mayo.

Turning to Athena's claims in the third part of her opinion, Judge Moore declares that "[i]t is my view that § 101 and Mayo, when read together and in their entireties, compel the holding that the claims in Athena are eligible."  Looking at Mayo, Judge Moore explains that:

The breadth and generality of the Mayo claims led to their demise, as they recited nothing more than the natural law.  We have since ignored these considerations, treating every claim that includes a law of nature as directed to that law, even if the claim as a whole recites a specific way of applying that law of nature to a new and useful end.

And she concludes that "[t]he Athena claims differ significantly from the Mayo claims."  In particular, she finds that "[t]he [Athena] claims are not directed to a natural law or phenomenon."  More specifically, Judge Moore explains that:

Athena discovered that 20% of people suffering from MG [Myasthenia gravis] generate autoantibodies that bind to a MuSK protein.  Its claims recite concrete steps to detect the presence of autoantibodies to MuSK to diagnose MG.  These antibody/MuSK complexes had never been used by prior art MG diagnostic tests.  In contrast, the claims in Mayo recited a generic "determining" step, with no laboratory test at all specified by the claims, and the specification itself stated that the methods were "well-understood, routine, and conventional activity already engaged in by the scientific community."

Judge Moore concludes her opinion by stating that she did "not believe that the Supreme Court intended Mayo to be the sweeping decision it has become," adding that:

I do not understand Mayo to render ineligible a claim which covers a specific, concrete application of a natural law simply because such a claim is diagnostic as opposed to therapeutic.  Both should be eligible.  The last word on this from the Supreme Court came in Myriad where the Court made clear "patents on new applications of knowledge about BRCA1 and BRCA2 genes" could be eligible.  569 U.S. at 596.  To the extent that this Court has read Mayo so broadly that it precludes exactly that sort of patent, we have erred.  Doing so leaves Mayo at odds with the patent statutes and the later Myriad decision.

As for diagnostic method claims, Judge Moore finds that their eligibility "is no longer uncertain," reiterating that "[s]ince Mayo, every diagnostic claim to come before this court has been held ineligible," and suggesting that there was no need for patentees "to waste resources with additional en banc requests," as "[y]our only hope lies with the Supreme Court or Congress."

In the second dissent (which a numbers just over thirteen pages), Judge Newman, who dissented in the panel decision, asserts in her opinion dissenting in the denial of the petition for rehearing en banc (which was joined by Judge Wallach) that:

The majority's position is a flawed interpretation of the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).  The Court did not hold that methods of diagnosis are subject to unique patent-eligibility rules.  We have mistakenly enlarged the Court's holding, in substance and in application.

Judge Newman begins her opinion by noting that with respect to Athena's claims, "[t]he reaction between the specified antibodies and the MuSK protein was not previously known, and the specified claim steps had not previously been performed, separately or in combination."  She then reminds that in Diamond v. Diehr, 450 U.S. 175, 188 (1981), the Supreme Court stressed that "[i]t is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis."  Judge Newman states that "[t]his established rule does not evaporate when the subject matter is a diagnostic method," adding that "[t]he Mayo Court did not effect such a change."

According to Judge Newman, the Mayo Court also did not create a § 101 distinction between diagnostic methods and therapeutic methods.  Nevertheless, she points to the Federal Circuit's "inconsistent rulings between diagnosis and treatment of disease," citing In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014); Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015); Genetic Technologies Ltd. v. Merial L.L.C. (Fed. Cir. 2016); Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017); Roche Molecular Systems, Inc. v. CEPHEID (Fed. Cir. 2018); and Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2019), as examples of cases in which "the claims were held ineligible under section 101, whether or not the method of diagnosis was new and unobvious, and independent of patentability under sections 102, 103, and 112"; and citing Rapid Litigation Management Ltd. v. CellzDirect, Inc. (Fed. Cir. 2016); Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int'l Ltd. (Fed. Cir. 2018); Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC (Fed. Cir. 2019); and Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2019), as examples of cases in which method of treatment claims were held to be patent eligible.

As for the instant case, Judge Newman concludes by stating that:

This case presents an opportunity for judicial review and judicial remedy.  Although diagnostic methods are not the only area in which section 101 jurisprudence warrants attention, Federal Circuit precedent is ripe for reconsideration specific to diagnostic methods, to correct our application of the Mayo decision and to restore the necessary economic incentive.

In the third dissent (which at three pages is the shortest of the four dissents), Judge Stoll, joined by Judge Wallach, contends that the Federal Circuit had, "[i]n a series of cases since the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), . . . established a bright-line rule of ineligibility for all diagnostic claims."  While conceding that "[t]his rule as applied to the facts of this case dictated that the majority panel find the claimed invention ineligible," she asserts that "this court's bright-line rule is based on an over-reaching and flawed test for eligibility, a test that undermines the constitutional rationale for having a patent system—promoting the progress of science and useful arts," and therefore she concluds that the Federal Circuit "should take this opportunity to correct its erroneous rule."

Despite indicating that she "stand[s] by the panel decision in this case," Judge Stoll explains that her dissent is warranted "because the question of the eligibility of diagnostic inventions is exactly the type of exceptionally important issue that warrants full consideration by this court."  She also states that:

En banc rehearing would not only permit us to have a more extensive view of the various considerations underlying Mayo, but it would also allow us to create judicial doctrine geared toward the practical application of Mayo's principles.  At the very least, en banc review would help the court develop an articulable standard for its § 101 jurisprudence moving forward.

Judge Stoll concludes by declaring that "[i]n my view, by consistently bypassing en banc review of a critical issue that goes to the heart of this court's jurisdiction, we are abdicating our responsibility."

In the fourth and final dissent (which numbers five pages), Judge O'Malley agrees with her dissenting colleagues that the Federal Circuit's precedent "applies the Supreme Court's holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) too broadly."  However, she also opines that:

[C]onfusion and disagreements over patent eligibility have been engendered by the fact that the Supreme Court has ignored Congress's direction to the courts to apply 35 U.S.C. sections 101, et seq ("Patent Act") as written.  Specifically, the Supreme Court has instructed federal courts to read into Section 101 an "inventive concept" requirement—a baffling standard that Congress removed when it amended the Patent Act in 1952.  I encourage Congress to amend the Patent Act once more to clarify that it meant what it said in 1952.

Judge O'Malley begins her opinion by providing some "historical perspective" on "the 'invention requirement'—itself 'invented' by the Supreme Court rather than Congress or the Constitution," noting that "[i]f the invention requirement and its criticisms sound familiar, that is because they are."  And Judge O'Malley suggests that even though, in 1952, "Congress attempted to address these criticisms by amending the Patent Act to replace the ill-defined and judicially-created invention requirement with the more workable anticipation and obviousness tests codified in Sections 102 and 103," "the search for an inventive concept—now enshrined in the § 101 inquiry via Mayo—calls back to the invention requirement that Congress quite deliberately abrogated through the Patent Act of 1952."

Judge O'Malley wonders whether the outcome in Athena would be different "[h]ad the Supreme Court not disregarded Congress's wishes for a second time."  She concludes by stating that:

Because the Supreme Court judicially revived the invention requirement and continues to apply it despite express abrogation, I dissent to encourage Congress to clarify that there should be no such requirement read into § 101; to clarify that concepts of novelty and "invention" are to be assessed via application of other provisions of the Patent Act Congress designed for that purpose.

Athena Diagnostics v. Mayo Collaborative Services -- The Concurrences

By Donald Zuhn --

On July 3, the Federal Circuit issued a per curiam Order in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, denying a petition for rehearing en banc filed by Plaintiffs-Appellants Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V.  The Court also denied Plaintiffs-Appellants a panel rehearing.

The four page per curiam Order was accompanied by eight opinions, four concurring in the denial of the petition and four dissenting in the denial of the petition, adding an additional 82 pages to the Order.  The four concurring opinions were authored by Circuit Judges Lourie, Hughes, Dyk, and Chen, with Chief Judge Prost and Circuit Judges Reyna, Taranto, and Hughes joining in one of the concurrences and Circuit Judge Chen joining in one concurrence and several parts of another.  The four dissenting opinions were authored by Circuit Judges Moore, Newman, Stoll, and O'Malley, with Circuit Judges O'Malley and Stoll joining in one of the dissents and Circuit Judge Wallach joining in three of the dissents.  Thus, a total of seven members of the Court (Chief Judge Prost and Circuit Judges Lourie, Dyk, Reyna, Taranto, Chen, and Hughes) authored or joined opinions concurring in the denial, and a total of five members (Circuit Judges Newman, Moore, O'Malley, Wallach, and Stoll) authored or joined opinions dissenting in the denial.

Last week, we reviewed the procedural history of the case and provided a brief summary of the eight concurring and dissenting opinions (see "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)").  In this post, we focus more closely on the four opinions concurring in the Order's denial of the petition for rehearing en banc.  As we noted last week, the general theme of the concurrences is that the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. left the members of the Court with no choice other than to deny the petition.

In the first concurrence, Judge Lourie, joined by Judges Reyna and Chen, declares in a 4-page opinion that the Court "can accomplish little in [rehearing the case en banc], as we are bound by the Supreme Court's decision in Mayo," adding that:

If I could write on a clean slate, I would write as an exception to patent eligibility, as respects natural laws, only claims directed to the natural law itself, e.g., E=mc2, F=ma, Boyle's Law, Maxwell's Equations, etc.  I would not exclude uses or detection of natural laws.  The laws of anticipation, obviousness, indefiniteness, and written description provide other filters to determine what is patentable.

"But," as Judge Lourie states, "we do not write here on a clean slate; we are bound by Supreme Court precedent."

Judge Lourie notes that the Federal Circuit has "held claims focused on detecting new and useful natural laws with conventional steps to be ineligible," citing Cleveland Clinic Found. v. True Health Diagnostics LLC and Ariosa Diagnostics, Inc. v. Sequenom, Inc. in support (without mentioning that both examples concern claims to diagnostic methods), but that "[i]n contrast, new method of treatment patents do not fall prey to Mayo's prohibition," citing Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd.  Judge Lourie also notes that "unconventional arrangements of known laboratory techniques, even if directed to a natural law" have also been found by the Federal Circuit to be patent eligible, citing Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc.  However, the instant case, as he points out, "involves neither scenario."

While explaining that "[t]he only unconventional aspect is the inventors' discovery of what the Supreme Court would call the natural law—the correlation between MuSK autoantibodies and the neurological disorder myasthenia gravis," Judge Lourie concedes that the Court "cannot premise eligibility solely on the natural law's novelty."  Judge Lourie also opines that:

Under Supreme Court precedent, I do not believe that specific yet purely conventional detection steps impart eligibility to a claim that otherwise only sets forth what the Court has held is a natural law.  That is the situation presented in Ariosa, Cleveland Clinic, and now Athena.  Accordingly, as long as the Court's precedent stands, the only possible solution lies in the pens of claim drafters or legislators.  We are neither.

And to those in the patent community (including amici) who have complained that the Federal Circuit's eligibility precedent is "confused," Judge Lourie responds that "our cases are consistent," explaining that the Court has "distinguished between new method of treatment claims and unconventional laboratory techniques, on the one hand, and, on the other hand, diagnostic methods that consist of routine steps to observe the operation of a natural law," which he finds to be "a clear line."  He concludes his opinion by stating that beyond this distinction, he does "not see a way clear to distinguish Mayo in a useful, principled, fashion," and therefore is left to concur with the denial of the petition "because I do not believe we can convincingly distinguish Mayo in this case."

In the second concurrence (which at a little over a page is the shortest of the concurring opinions), Judge Hughes, joined by Chief Judge Prost and Judge Taranto, notes that "[t]he multiple concurring and dissenting opinions regarding the denial of en banc rehearing in this case are illustrative of how fraught the issue of § 101 eligibility, especially as applied to medical diagnostics patents, is."  However, he also notes that while "the bottom line for diagnostics patents is problematic . . . this is not a problem that we can solve," adding that "[a]s an inferior appellate court, we are bound by the Supreme Court."

Judge Hughes concludes by stating that:

I, for one, would welcome further explication of eligibility standards in the area of diagnostics patents.  Such standards could permit patenting of essential life saving inventions based on natural laws while providing a reasonable and measured way to differentiate between overly broad patents claiming natural laws and truly worthy specific applications.  Such an explication might come from the Supreme Court.  Or it might come from Congress, with its distinctive role in making the factual and policy determinations relevant to setting the proper balance of innovation incentives under patent law.

In the third concurrence (which numbers more than thirteen pages), Judge Dyk, joined by Judges Hughes and Chen (with Judge Chen only joining the last three parts of the concurrence), points out (to begin Part IV of his opinion) that:

[T]here is tension between Mayo and the Supreme Court's later decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and that the holding of Mayo may be overbroad.  The language of § 101 does cover "discover[ies]," 35 U.S.C. § 101, and there is no doubt that determining the relationship between specific genetic abnormalities and specific diseases constitutes an important discovery with proven utility.  There is much to be said for the patentability of claims to such discoveries, if not drafted overbroadly.

Of the authors of the four concurring opinions, Judge Dyk stands apart in finding something beneficial in the Supreme Court's precedent on subject matter eligibility.  In Part I of his opinion, Judge Dyk explains that:

In the realm of abstract ideas, the Mayo/Alice framework has successfully screened out claims that few would contend should be patent eligible, for example, those that merely apply well-known business methods and other processes using computers or the Internet.  The Mayo/Alice framework has thus proven to be both valuable and effective at invalidating overly broad, non-inventive claims that would effectively "grant a monopoly over an abstract idea."

In support of his position, he cites Trading Techs. Int'l, Inc. v. IBG LLC (Fed. Cir. 2019); SAP Am., Inc., v. Investpic, LLC (Fed. Cir. 2018); Credit Acceptance Corp. v. Westlake Servs. (Fed. Cir. 2017); Elec. Power Grp., LLC v. Alstom S.A. (Fed. Cir. 2016); Intellectual Ventures I LLC v. Capital One Bank (Fed. Cir. 2015); Ultramercial, Inc. v. Hulu, LLC (Fed. Cir. 2014); and buySAFE, Inc. v. Google, Inc. (Fed. Cir. 2014).  However, Judge Dyk also notes that the Federal Circuit's subject matter eligibility precedent "has allowed room for claims that do more than recite conventional applications of abstract concepts," citing Ancora Techs., Inc. v. HTC Am., Inc. (Fed. Cir. 2018); Finjan, Inc. v. Blue Coat Sys., Inc. (Fed. Cir. 2018); and Enfish, LLC v. Microsoft Corp. (Fed. Cir. 2016) in support.

In Part II of his opinion, Judge Dyk defends the need for Alice/Mayo framework, contending that "[d]espite assertions to the contrary, the doctrines of novelty under § 102, obviousness under § 103, and enablement and written description under § 112 cannot adequately guard against the dangers of overclaiming."  Judge Dyk also notes that these provisions do not "typically allow early stage resolution of the 'threshold' issue of patent eligibility . . . necessary to avoid the costs of lengthy litigation," and therefore concludes that the patent eligibility analysis of "§ 101 serves an important purpose not served by these other provisions in the Patent Act."  Offering an example of the alleged inadequacy of the other provisions to guard against overclaiming, Judge Dyk suggests that "[i]f the first person to identify the relationship between a genetic abnormality and a disease had sought a broad patent on a method of searching for genetic abnormalities and determining their relationship to disease, the claims would have been neither anticipated nor obvious."

For Judge Dyk, "[t]he problem with § 101 arises not in implementing the abstract idea approach of Alice, but rather in implementing the natural law approach of Mayo," explaining in Part III of his opinion that "[a]lthough Mayo's framework is sound overall, I share the concerns expressed by my dissenting colleagues that the Mayo test for patent eligibility should leave room for sufficiently specific diagnostic patents."  However, as Judge Hughes indicated in his concurrence, Judge Dyk states that "it is the Supreme Court, not this court, that must reconsider the breadth of Mayo."

In Part IV of his concurrence, Judge Dyk elaborates on the tension between the Supreme Court's decisions in Mayo and Myriad, stating that:

Myriad thus recognized that an inventive concept can sometimes come from the discovery of an unknown natural phenomenon and its application for a diagnostic purpose.  This appears to be in tension with Mayo.  Under Mayo, a natural phenomenon itself, no matter how narrow and specific, cannot supply the requisite "inventive concept."

Judge Dyk suggests that "it would be desirable for the Supreme Court to refine the Mayo framework to allow for sufficiently specific diagnostic patent claims with proven utility," contending that "[t]he inventive concepts in this area may lie primarily in the application of a natural law."

According to Judge Dyk, however, the refinements to the Mayo framework that are needed are "limited."  In particular, Judge Dyk explains in Part V of his opinion that "if the claim is sufficiently tied to a specific and useful application of a natural law at Mayo step one, that application itself should serve as the necessary inventive concept at Mayo step two."  However, "the application must be more than determining the precise correlation of a known relationship using prior art processes, as was the case in Mayo itself."

With respect to the claims at issue in Athena, Judge Dyk suggests in Part VI of his concurrence that "this case may involve claims that could be patent eligible under []his suggested approach."  He points out that "claims 7–9 do not claim the natural law itself—the relationship between MuSK autoantibodies and MG, a rare neurological disorder—but rather claim specific methods of diagnosing neurological disorders like MG by detecting MuSK autoantibodies."  Thus, according to Judge Dyk, Athena, unlike Mayo, "involves a 'discovery' of the relationship, not mere determination of the precise correlations of a known natural law using prior art processes."  Judge Dyk concludes his opinion by suggesting that "this case could provide the Supreme Court with the opportunity to refine the Mayo framework as to diagnostic patents."

In the fourth and final concurrence (which at more than sixteen pages is the longest of the concurring opinions), Judge Chen states that "[w]hile I believe our court would benefit from the Supreme Court's guidance as to whether it intended to override central tenets of [Diamond v.] Diehr [450 U.S. 175 (1981)], Mayo's reasoning is clear and we are bound by it," adding that the analysis in Mayo "requires the affirmance of the district court’s decision to invalidate Athena's claims."  Judge Chen notes, however, that "[e]ven though Athena's claims likely would be found patent-eligible under Diehr's framework, it is not an inferior court's role to dodge the clear, recent direction of the Supreme Court."

Judge Chen begins his concurrence by noting that the Supreme Court in Diehr "adopted a relatively narrow and more administrable version of the judicial exceptions to the statutory text of 35 U.S.C. § 101 compared to what the Court articulated three years earlier in Parker v. Flook, 437 U.S. 584 (1978)."  He also suggests that "[u]nder Diehr's 'claim as a whole' principle, which does not divide the claim into new versus old elements, Athena's claims, particularly claims 7 and 9, likely would have been found to be directed to a patent-eligible process."  However, he acknowledges that in Mayo, the Supreme Court "set forth an inventive concept/point of novelty framework, which is a more far-reaching, aggressive version of the judicial exceptions to the statute and is largely incompatible with Diehr's core rationale," even though "nothing in Mayo suggests that it sought to repudiate Diehr's analysis."

Judge Chen provides a detailed analysis of Diehr, Flook, Mayo, and Alice, before turning to Athena's claims.  With respect to Diehr and Flook, Judge Chen contends that "[g]iven Diehr's evident disagreement with Flook's analysis, Diehr, as the later opinion, was widely understood to be the guiding, settled precedent on § 101 for three decades," with Diehr "reject[ing] the point of novelty/inventive concept approach to patent eligibility."  According to Judge Chen, "Mayo provided a framework for the judicial exceptions that strongly tracked the reasoning of Flook and the Diehr dissent."  Thus, Judge Chen argues that "Mayo is in considerable tension with Diehr's instruction to consider claims 'as a whole' and Diehr's disapproval of dissecting claims into elements and ignoring non-novel elements in the § 101 analysis."  And, as Judge Chen explains:

When it comes to applying the judicial exceptions, it bears noting that the Mayo analytical approach is considerably harder to apply consistently than the Diehr framework, and more aggressive in its reach.  Consider the claim in Mayo.  If that claim had recited just the single step of administering a synthetic drug to a patient, that single-step claim would be patent-eligible, but lack novelty under § 102.  And if that claim added a second step for determining the subsequent level of a non-naturally occurring metabolite in a patient, that claim also would pass muster under § 101, but lack novelty.  But when the claim further recites a relationship between a metabolite level and its efficacy in a patient, that claim suddenly would be invalid under § 101 for violating the law of nature exception.  In other words, steps 1 and 2 now get pushed aside and declared insignificant, and the last step is designated as the "focus" of the claim, i.e., the heart of the invention.  The notion that adding claim language can convert an otherwise patent-eligible claim into a patent-ineligible claim is counterintuitive and a very difficult thing to explain to 8,000 patent examiners.  Moreover, the process of determining what the claim is "really about" when the claim is viewed in pieces, rather than as a whole, can be highly subjective and impressionistic.

According to Judge Chen, "there is a serious question today in patent law as to what extent Diehr remains good law in light of Mayo," and he indicates that this is a question for the Supreme Court to resolve.

In the last part of his opinion, Judge Chen examines the claims at issue in Athena.  While conceding that "the Supreme Court has made clear that detecting a law of nature (without more than conventional steps for accessing the law of nature) does not qualify as a patent-eligible application of a law of nature," Judge Chen notes that "given that the dual 'invention or discovery' structure consistently has been part of every Patent Act since 1790, this statutory provision suggests that at least some discoveries, including Athena's 'discovery' of how to diagnose myasthenia gravis, have always been contemplated as patentable subject matter."  Thus, while Judge Chen "do[es] not think the claims here can withstand Mayo's scrutiny," he argues that "perhaps when read 'as a whole' under Diehr, claims such as claims 7 and 9 in this case could be viewed as methods of testing for a specific medical condition, employing a sequence of steps that physically transform materials," adding that "this sounds like a contribution to the 'useful arts' stated in Article I, Section 8, Clause 8 of the U.S. Constitution."

Judge Chen concludes his opinion by suggesting that:

New methods for diagnosing medical conditions, as a general matter, intuitively seem to be the kind of subject matter the patent system is designed for:  to encourage the risky, expensive, unpredictable technical research and development that people would not otherwise pursue in the hope that if they discover something of great medical value, then they will be protected and rewarded for that successful effort with a patent.

Nevertheless, Judge Chen declares that he is bound by "the clear, recent direction of the Supreme Court" to concur with the denial of Athena's petition for rehearing en banc.

In a subsequent post, we will focus more closely on the dissenting opinions.

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)

By Donald Zuhn --

Last week, the Federal Circuit issued a per curiam Order in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, denying a petition for rehearing en banc filed by Plaintiffs-Appellants Athena Diagnostics, Inc., Oxford University Innovation Ltd., and the Max-Planck-Gesellschaft zur Forderung der Wissenschaften E.V.  The Court also denied Plaintiffs-Appellants a panel rehearing.

The four-page per curiam Order was accompanied by eight opinions, four concurring in the denial of the petition and four dissenting in the denial of the petition, adding an additional 82 pages to the Order.  The four concurring opinions were authored by Circuit Judges Lourie, Hughes, Dyk, and Chen, with Chief Judge Prost and Circuit Judges Reyna, Taranto, and Hughes joining in one of the concurrences and Circuit Judge Chen joining in one concurrence and several parts of another.  The four dissenting opinions were authored by Circuit Judges Moore, Newman, Stoll, and O'Malley, with Circuit Judges O'Malley and Stoll joining in one of the dissents and Circuit Judge Wallach joining in three of the dissents.  Thus, a total of seven members of the Court (Chief Judge Prost and Circuit Judges Lourie, Dyk, Reyna, Taranto, Chen, and Hughes) authored or joined opinions concurring in the denial, and a total of five members (Circuit Judges Newman, Moore, O'Malley, Wallach, and Stoll) authored or joined opinions dissenting in the denial.

Before turning to the eight opinions concurring or dissenting in the Order's denial of the petition for rehearing en banc, it may be helpful to review the procedural history of this case.  In February, a divided panel affirmed a decision by the District Court for the District of Massachusetts, holding claims 6-9 of U.S. Patent No. 7,267,820 invalid under 35 U.S.C. § 101, and dismissing under Fed. R. Civ. P. 12(b)(6) a complaint filed by Plaintiffs-Appellants for infringement of the '820 patent.

Athena Diagnostics is the exclusive licensee of the '820 patent, which is directed to methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK).  Athena markets a test called FMUSK that functions by evaluating those antibodies.  After Mayo developed two competing tests, Athena filed suit against Mayo for infringement of the '820 patent, and Mayo moved to dismiss under Rule 12(b)(6), arguing that the asserted claims of the '820 patent were invalid under § 101 for claiming patent ineligible subject matter.  The District Court granted Mayo's motion, and Athena appealed for a determination of whether claims 6-9 are patent eligible under § 101.

The '820 patent notes that about 80% of patients with Myasthenia gravis (MG) produce acetylcholine receptor autoantibodies, and that the remaining 20% do not.  The named inventors of the '820 patent discovered that many of the 20% of MG patients without acetylcholine receptor autoantibodies instead generate autoantibodies to MuSK.  The '820 patent discloses and claims methods of diagnosing neurological disorders such as MG by detecting autoantibodies that bind to a MuSK epitope.  The '820 patent contains only one independent claim, which, while not at issue in the case, recites:

1.  A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK).

Claims 6-9, which were at issue in the case, recite:

6.  A method according to claim 3 whereby the intensity of the signal from the anti-human IgG antibody is indicative of the relative amount of the anti-MuSK autoantibody in the bodily fluid when compared to a positive and negative control reading.

7.  A method according to claim 1, comprising contacting MuSK or an epitope or antigenic determinant thereof having a suitable label thereon, with said bodily fluid, immunoprecipitating any antibody/MuSK complex or antibody/MuSK epitope or antigenic determinant complex from said bodily fluid and monitoring for said label on any of said antibody/MuSK complex or antibody/MuSK epitope or antigen determinant complex, wherein the presence of said label is indicative of said mammal is suffering from said neurotransmission or developmental disorder related to muscle specific tyrosine kinase (MuSK).

8.  A method according to claim 7 wherein said label is a radioactive label.

9.  A method according to claim 8 wherein said label is 125I.

In the panel opinion, authored by Judge Lourie and joined by Judge Stoll (with Judge Newman dissenting), the Court affirmed the District Court's determination that claims 6-9 are invalid under § 101.  The panel majority "ultimately agree[d] with Mayo that, under Mayo [Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 70 (2012)], the claims are directed to a natural law," and that in the instant case, the natural law "is the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like MG."  The panel majority also agreed with Mayo that "the steps of the claims not drawn to ineligible subject matter, whether viewed individually or as an ordered combination, only require standard techniques to be applied in a standard way."  In a lengthy footnote, the panel majority responded to Judge Newman's dissent by explaining that:

The dissent states much that one can agree with from the standpoint of policy, and history, including that "the public interest is poorly served by adding disincentive to the development of new diagnostic methods."  We would add further that, in our view, providing patent protection to novel and non-obvious diagnostic methods would promote the progress of science and useful arts.  But, whether or not we as individual judges might agree or not that these claims only recite a natural law, . . . the Supreme Court has effectively told us in Mayo that correlations between the presence of a biological material and a disease are laws of nature, and "[p]urely 'conventional or obvious' '[pre]-solution activity' is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law," . . . .  Our precedent leaves no room for a different outcome here [citations omitted].

In her dissent, Judge Newman declared that "[t]he court again departs from the cautious restraints in the Supreme Court's Mayo/Alice application of laws of nature and abstract ideas," adding that "[t]his court's decisions on the patent-ineligibility of diagnostic methods are not consistent, and my colleagues today enlarge the inconsistencies and exacerbate the judge-made disincentives to development of new diagnostic methods, with no public benefit."  She contended that "[t]he '820 inventors did not patent their scientific discovery of MuSK autoantibodies," but rather "applied this discovery to create a new method of diagnosis, for a previously undiagnosable neurological condition."

Turning to the eight opinions concurring or dissenting in the Order's denial of the petition for rehearing en banc, the general theme of the concurrences is that the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. left the members of the Court with no choice other than to deny the petition:

• Judge Lourie, joined by Judges Reyna and Chen, declared that the Court "can accomplish little in [rehearing the case en banc], as we are bound by the Supreme Court's decision in Mayo," adding that:

If I could write on a clean slate, I would write as an exception to patent eligibility, as respects natural laws, only claims directed to the natural law itself, e.g., E=mc2, F=ma, Boyle's Law, Maxwell's Equations, etc.  I would not exclude uses or detection of natural laws.  The laws of anticipation, obviousness, indefiniteness, and written description provide other filters to determine what is patentable.

"But," as Judge Lourie stated, "we do not write here on a clean slate; we are bound by Supreme Court precedent."

• Judge Hughes, joined by Chief Judge Prost and Judge Taranto, noted that "[t]he multiple concurring and dissenting opinions regarding the denial of en banc rehearing in this case are illustrative of how fraught the issue of § 101 eligibility, especially as applied to medical diagnostics patents, is."  However, he also noted that while "the bottom line for diagnostics patents is problematic . . . this is not a problem that we can solve," adding that "[a]s an inferior appellate court, we are bound by the Supreme Court."

• Judge Dyk, joined by Judges Hughes and Chen (with Judge Chen only joining the last three parts of the concurrence), pointed out (to begin Part IV of his opinion) that:

[T]here is tension between Mayo and the Supreme Court's later decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and that the holding of Mayo may be overbroad.  The language of § 101 does cover "discover[ies]," 35 U.S.C. § 101, and there is no doubt that determining the relationship between specific genetic abnormalities and specific diseases constitutes an important discovery with proven utility.  There is much to be said for the patentability of claims to such discoveries, if not drafted overbroadly.

• Judge Chen stated that "[w]hile I believe our court would benefit from the Supreme Court's guidance as to whether it intended to override central tenets of [Diamond v.] Diehr [450 U.S. 175 (1981)], Mayo's reasoning is clear and we are bound by it," adding that the analysis in Mayo "requires the affirmance of the district court’s decision to invalidate Athena's claims." Judge Chen concluded his opinion by noting that "[e]ven though Athena's claims likely would be found patent-eligible under Diehr's framework, it is not an inferior court's role to dodge the clear, recent direction of the Supreme Court."

Several of the dissenting authors disagreed with the concurring authors that Mayo compelled a finding of patent ineligibility in this case:

• Judge Moore, joined by Judges O'Malley, Wallach, and Stoll, disagreed with "[t]he majority of my colleagues [that] believe that our hands are tied and that Mayo requires this outcome," indicating instead that "[t]he claims in this case should be held eligible, and they are distinguishable from Mayo."  Judge Moore contended that the Court "should reconsider this case and clarify our precedent."

• Judge Newman, who dissented in the panel decision, asserted in her dissenting opinion (which was joined by Judge Wallach) that:

The majority's position is a flawed interpretation of the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).  The Court did not hold that methods of diagnosis are subject to unique patent-eligibility rules.  We have mistakenly enlarged the Court's holding, in substance and in application.

• Judge Stoll, joined by Judge Wallach, contended that the Federal Circuit had, "[i]n a series of cases since the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), . . . established a bright-line rule of ineligibility for all diagnostic claims."  While conceding that "[t]his rule as applied to the facts of this case dictated that the majority panel find the claimed invention ineligible," she asserted that "this court's bright-line rule is based on an over-reaching and flawed test for eligibility, a test that undermines the constitutional rationale for having a patent system—promoting the progress of science and useful arts," and therefore she concluded that the Federal Circuit "should take this opportunity to correct its erroneous rule."

• While Judge O'Malley agreed with her dissenting colleagues that Federal Circuit precedent "applies the Supreme Court's holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) too broadly," she also opined that:

[C]onfusion and disagreements over patent eligibility have been engendered by the fact that the Supreme Court has ignored Congress's direction to the courts to apply 35 U.S.C. sections 101, et seq ("Patent Act") as written.  Specifically, the Supreme Court has instructed federal courts to read into Section 101 an "inventive concept" requirement—a baffling standard that Congress removed when it amended the Patent Act in 1952.  I encourage Congress to amend the Patent Act once more to clarify that it meant what it said in 1952.

In subsequent posts, we will focus more closely on the concurring and dissenting opinions.

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)
Per curiam
Circuit Judge Lourie concurring in the denial of the petition for rehearing en banc, joined by Circuit Judges Reyna and Chen;
Circuit Judge Hughes concurring in the denial of the petition for rehearing en banc, joined by Chief Judge Prost and Circuit Judge Taranto;
Circuit Judge Dyk concurring in the denial of the petition for rehearing en banc, joined by Circuit Judge Hughes and joined as to Parts IV, V, and VI by Circuit Judge Chen;
Circuit Judge Chen concurring in the denial of the petition for rehearing en banc;
Circuit Judge Moore dissenting from the denial of the petition for rehearing en banc, joined by Circuit Judges O'Malley, Wallach, and Stoll;
Circuit Judge Newman dissenting from the denial of the petition for rehearing en banc, joined by Circuit Judge Wallach;
Circuit Judge Stoll dissenting from the denial of the petition for rehearing en banc, joined by Circuit Judge Wallach;
Circuit Judge O'Malley dissenting from the denial of the petition for rehearing en banc.

Cellspin Soft, Inc. v. Fitbit, Inc. (Fed. Cir. 2019)

By Michael Borella --

Background

Cellspin Soft Inc. (Cellspin) filed an infringement suit against Fitbit Inc. (Fitbit) and ten other defendants in the Northern District of California, asserting U.S. Patent Nos. 8,738,794, 8,892,752, 9,258,698, and 9,749,847.  These patents have a common specification and their claims are directed to a data capture device being connected to a mobile device so that captured data can be published to a web site.  The defendants moved the District Court to dismiss all counts under Rule 12(b)(6) or 12(c), alleging that the patents did not meet the eligibility requirements of 35 U.S.C.§ 101.  Ultimately, the District Court not only granted this motion, but also awarded the defendants attorney fees under § 285.  Cellspin appealed.

In Alice Corp. v. CLS Bank Int'l, the Supreme Court set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101.  One must first decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion.  But elements or combinations of elements that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle.  While this inquiry is generally carried out as a matter of law, factual issues can come into play when determining whether something is well-understood, routine, and conventional.

The Claimed Inventions

As a representative example of the claimed inventions, the '794 patent "teaches a way to transfer and upload data automatically or with minimal user intervention using a data capture device and a mobile device."  Notably, a client application on the mobile device wirelessly receives data from the data capture device and then publishes this data to one or more websites.  Such a procedure takes place "automatically or with minimal user intervention."

Claim 1 of this patent recites:

A method for acquiring and transferring data from a Bluetooth enabled data capture device to one or more web services via a Bluetooth enabled mobile device, the method comprising:
    providing a software module on the Bluetooth enabled data capture device;
    providing a software module on the Bluetooth enabled mobile device;
    establishing a paired connection between the Bluetooth enabled data capture device and the Bluetooth enabled mobile device;
    acquiring new data in the Bluetooth enabled data capture device, wherein new data is data acquired after the paired connection is established;
    detecting and signaling the new data for transfer to the Bluetooth enabled mobile device, wherein detecting and signaling the new data for transfer comprises:
        determining the existence of new data for transfer, by the software module on the Bluetooth enabled data capture device; and
        sending a data signal to the Bluetooth enabled mobile device, corresponding to existence of new data, by the software module on the Bluetooth enabled data capture device automatically, over the established paired Bluetooth connection, wherein the software module on the Bluetooth enabled mobile device listens for the data signal sent from the Bluetooth enabled data capture device, wherein if permitted by the software module on the Bluetooth enabled data capture device, the data signal sent to the Bluetooth enabled mobile device comprises a data signal and one or more portions of the new data;
        transferring the new data from the Bluetooth enabled data capture device to the Bluetooth enabled mobile device automatically over the paired Bluetooth connection by the software module on the Bluetooth enabled data capture device;
        receiving, at the Bluetooth enabled mobile device, the new data from the Bluetooth enabled data capture device;
        applying, using the software module on the Bluetooth enabled mobile device, a user identifier to the new data for each destination web service, wherein each user identifier uniquely identifies a particular user of the web service;
        transferring the new data received by the Bluetooth enabled mobile device along with a user identifier to the one or more web services, using the software module on the Blue-tooth enabled mobile device;
        receiving, at the one or more web services, the new data and user identifier from the Bluetooth enabled mobile device, wherein the one or more web services receive the transferred new data corresponding to a user identifier; and
        making available, at the one or more web services, the new data received from the Bluetooth enabled mobile device for public or private consumption over the internet, wherein one or more portions of the new data correspond to a particular user identifier.

The other asserted claims are substantially similar, though they recite further variations including: (1) a polling mechanism through which the mobile device checks for and then pulls data from the data capture device, (2) establishing a connection between the mobile device and the data capture device using encryption, (3) the mobile device using the hypertext transfer protocol (HTTP) to transfer the captured data to the web sites, and (4) broader embodiments that do not use Bluetooth.

District Court Proceedings

One month after the defendants filed the motion to dismiss, Cellspin filed a notice of supplemental authority.  The notice cited the recently-decided Aatrix Software, Inc. v. Green Shades Software, Inc. and Berkheimer v. HP Inc., two cases that established the contours of the factual analysis in the Alice test's second part.  Cellspin also amended its complaints to allege that the combination of elements recited by the claims was unconventional at the time the patents were filed.

Applying part one of the Alice test, the District Court found that the claims were directed to the abstract idea of "acquiring, transferring, and publishing data and multimedia content on one or more websites."  The District Court noted that "Cellspin failed to show that the data acquisition, transfer, and publication described in the '794 patent represents something more than a simple automation of a conventional (manual) process."

Moving on the part two, the District Court "concluded that the various claim elements, e.g., the data capture device and Bluetooth enabled mobile device, represent generic computer components performing as expected according to their ordinary use."  The District Court acknowledged that there was a factual dispute between the parties regarding whether the combination of these elements was well-understood, routine, and conventional.  But the District Court declined to take this factual dispute into account because, in the District Court's view, Berkheimer only applied to the summary judgment stage, and also because Cellspin did not identify where the specification described the unconventional aspects of the claimed inventions as alleged in the amended complaint.  Thus, all claims were found invalid under § 101.

A number of the defendants moved the District Court for attorney fees.  The District Court found that the case met the definition of "exceptional" under § 285 because the "claims were manifestly directed to an abstract idea" and "exceptionally meritless."  Further, the District Court determined that Cellspin litigated aggressively, noting that Cellspin amended "its complaint only three days prior to the hearing on the motions to dismiss."

The District Court further admonished Cellspin for "a refusal to analyze its patents critically before filing suit," noting that "Cellspin could have litigated a test case but instead chose to file and pursue aggressively fourteen lawsuits simultaneously."  The District Court recommended this approach because "Cellspin's patents are not presumed eligible under Section 101."

Based on these factors, the District Court awarded attorney fees to the defendants.

Appeal to the Federal Circuit

On appeal, the Federal Circuit re-applied the Alice test and also considered the attorney fees award.

Particularly, the Court found that, under part one of Alice, the claims were indeed directed to an abstract idea.  The Court determined that this outcome was required given the similarities between Cellspin's claims and those held abstract in In re TLI Communications LLC Patent Litigation ("claims reciting recording . . . transmitting . . . and storing digital images were directed to an abstract idea") and Elec. Power Grp., LLC v. Alstom S.A. ("claims reciting collecting information, analyzing it, and displaying certain results" are typically abstract in nature).

Moving on to part two of Alice, the Court looked to Cellspin's amended complaint for allegations that its claims are unconventional.  There, it found Cellspin's argument that "prior art devices included a capture device with built in mobile wireless Internet," and that "at the time of the patent priority date . . . the combined apparatus was bulky, expensive in terms of hardware, and expensive in terms of requiring a user to purchase an extra and/or separate cellular service for the data capture device."  Cellspin further argued that "it was unconventional to separate the steps of capturing and publishing data so that each step would be performed by a different device linked via a wireless, paired connection" and that doing so "allows data capture devices to be smaller and cheaper to build."  Additionally, Cellspin asserted that the ordering of the claimed elements was also unconventional, as prior art devices "forwarded data to a mobile device as captured," whereas the claims involve "establishing a paired connection between the mobile device and the data capture device before data is transmitted."  According to Cellspin, this has the advantage of data only being transmitted "if the mobile device is capable of receiving it."

As noted above, the District Court faulted Cellspin for not citing to support in the specification for these allegations.  But the Federal Circuit disagreed that this was required, noting that under Aatrix, "allegations in the complaint [are sufficient] to conclude that the disputed claims were potentially inventive."  The Court went on:

While we do not read Aatrix to say that any allegation about inventiveness, wholly divorced from the claims or the specification, defeats a motion to dismiss, plausible and specific factual allegations that aspects of the claims are inventive are sufficient.  As long as what makes the claims inventive is recited by the claims, the specification need not expressly list all the reasons why this claimed structure is unconventional.  In this case, Cellspin made specific, plausible factual allegations about why aspects of its claimed inventions were not conventional, e.g., its two-step, two-device structure requiring a connection before data is transmitted.  The district court erred by not accepting those allegations as true.

The Court also made it clear that Aatrix "expressly stated that patentees who adequately allege their claims contain inventive concepts survive a § 101 eligibility analysis under Rule 12(b)(6)."  Thus, the District Court's reliance on Berkheimer to discount Cellspin's allegations was misplaced.

Putting this all together, the Court stated "accepting the allegations stated above as true, we cannot conclude that the asserted claims lack an inventive concept . . . we have no basis, at the pleadings stage, to say that these claimed techniques, among others, were well-known or conventional as a matter of law."  A major factor that led the Court toward this conclusion was that "Cellspin did more than simply label [the claimed] techniques as inventive . . . [i]t pointed to evidence suggesting that these techniques had not been implemented in a similar way."  Thus, based on the allegations, the claims "recite a specific, plausibly inventive way of arranging devices and using protocols rather than the general idea of capturing, transferring, and publishing data," and cannot be found ineligible at this point in the case.

As the District Court's opinion was vacated, the attorney fees award was necessarily vacated as well.  To that point, the Federal Circuit clarified the principle that an issued patent has a presumption of validity:

This presumption reflects the fact that the Patent and Trademark Office has already examined whether the patent satisfies the prerequisites for issuance of a patent, including § 101.  While an alleged infringer may attempt to prove that the patent never should have issued in the first place, i.e., challenge its validity, the alleged infringer must prove that the patent does not satisfy these prerequisites before the patent loses its presumption of validity.  To the extent the district court departed from this principle by concluding that issued patents are presumed valid but not presumed patent eligible, it was wrong to do so.

The Court also found that the District Court erred when admonishing Cellspin for amending its complaints so close to the hearing thereon.  Looking to the record, the Court observed that "Cellspin's amendment was timely based on a scheduling order entered by the district court just three days before Cellspin's amendment," and that "Cellspin's decision to amend was also justified in light of Berkheimer and Aatrix, decided just a few weeks earlier."

Thus, both issues of patent eligibility and attorney fees were remanded to the District Court for further review.

Cellspin Soft, Inc. v. Fitbit, Inc. (Fed. Cir. 2019)
Panel: Circuit Judges Loruie, O'Malley, and Taranto
Opinion by Circuit Judge O'Malley

Biotech Prospects for Patent Reform

By Kevin E. Noonan --

With great fanfare (and a seeming exercise of appropriate diligence), Senators Thom Tillis (R-NC) and Chris Coons (D-DE), chair and ranking member of the Intellectual Property Subcommittee of the Senate Judiciary committee, over the past few weeks have held a series of public hearings on the subject of legislative intervention to reform patent eligibility law rendered somewhat askew by several recent Supreme Court decisions (and, to be fair, how those decisions have been expansively, if not slavishly, implemented by the U.S. Patent and Trademark Office and the inferior courts, including the Federal Circuit).

On Monday, the Senators posted a synopsis of their recent efforts, entitled "What We Learned at Patent Reform Hearings."  This synopsis is generally informative but particularly with regard to the Senators' understanding and commitment (at least for now) to solving the problems caused to the life sciences industry by the Court's decisions in Mayo v. Prometheus (as interpreted by CLS Bank v. Alice) and AMP v. Myriad Genetics.

Their missive begins with the almost requisite encomiums to innovation and entrepreneurship, and the contributions of the patent system to U.S. success in these endeavors.  The Senators certainly "get it" with regard to the problem, saying that "[o]ver time, courts have clouded the [patent eligibility] line to exclude critical medical advances like life-saving precision medicine and diagnostics.  Recent decisions have also made it difficult to predict whether exciting and important technologies like artificial intelligence make the cut."  And they are careful (in these fraught days) to be sure to mention that their efforts have been "thorough, thoughtful, bipartisan and bicameral legislating."  But the need is clear:  "the U.S. patent system with regard to patent eligibility is broken and desperately needs to be repaired" because "[t]he U.S. Supreme Court has confused and narrowed Section 101 of the Patent Act to the point that investors are reluctant to pursue the innovations that propel our country forward."  A more succinct and damning indictment by one branch of government of another is (fortunately) rare and even more significant because (in large part) it is true (although again, to be fair, the Supreme Court undoubtedly did not intend the consequences of its rather Delphic pronouncements on patent subject matter eligibility).  These Senators' position that Congress needs to step in is further justified, according to their statement, in that there have been "over 40 [actually, 42]" denials of petitions for certiorari on patent eligibility issues, indicating the Supreme Court's refusal to address the issue and as a result the lower courts and USPTO are and have been unable to ignore this precedent (but, until recently, it is at least arguable whether they have tried particularly hard to do so).

And what of the concerns of the life sciences industry?  It is gratifying for those laboring in these particularly patent-infertile fields that the Senators understand how the life sciences have been specifically hard-hit by the current climate.  The statement cites the Ariosa v. Sequenom case, not only because of the groundbreaking nature of the technology (and its beneficial effects on women no longer needing to be subjected to invasive procedures to obtain important diagnostic information about their babies), but because those individuals charged with stewarding U.S. patent law, embodied in Judge Richard Linn's "concurring" opinion in Ariosa, have said that there is discernably "no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible."

The Senators attest that they have considered the testimony of the naysayers, who are concerned that the current system "provides a mechanism to terminate baseless patent infringement lawsuits quickly and efficiently," but while acknowledging them (and the need for taking steps to mitigate these problems), the Senators understand that courts cannot be permitted to "destabilize" the patent system in an effort to correct issues like "deterring nuisance litigation."  They are also careful to rebut the allegation that their proposal would "permit patenting of scientific research per se, mere abstract ideas and nontechnical methods of doing business," specifying that "our patent system was never intended to protect artistic creations, methods of investing, or items found in nature" (although the latter category would do with a bit of clarification and limitation as to its scope).

The Senators are also careful to state that by abrogating the "judicial exceptions" in prior case law they do not intend to reverse the individual outcomes of these cases; some, they say, were decided correctly while others excluded inventions that should have been deemed eligible for patenting.  But they recognize that the issue is one of proper application of patent law to questions of prosecution, validity, and infringement, and that the Supreme Court's calculus has "collapsed" in error the more nuanced (yet well-defined) requirements for patentability into Section 101.  In view of the propensity for many of the "naysayers" to be representatives of the electrical, mechanical, and "high technology" arts, the Senators wisely cite as an example of the errors occasioned by recent precedent invalidation of claims to a "network charging station for electric vehicles," subject matter having much less emotional impact than, for example, gene patenting.  And Senators Tillis and Coons characterize as "admissions" concessions from high-tech representatives and legal academics that the law was being improperly applied to life sciences inventions.

Turning to the ACLU and their fellow travellers, the Senators address their concerns (which are to preserve their signal, albeit Pyrrhic, victory over gene patents):

Other witnesses, including the American Civil Liberties Union, expressed concerns about the patenting of human genes.  As we stated at the hearing, it is not our intent to allow such patents, and several witnesses, including the Association of American Universities and the Intellectual Property Owners Association, disagreed that our proposal would enable that result.

Testimony at the hearings further clarified that — because the entire human genome has been mapped for many years — these concerns are misplaced.  That said, we want to be very clear on this point, and we welcome proposals to clarify our proposed legislation.

So what do the Senators see as the aim of their legislation with regard to life sciences inventions?  It includes at least this:

We do want to incentivize research and development into the exciting prospects of individualized diagnostics and precision medicine, which is tied to genetics.  We are working hard to ensure the protections that will enable our innovators to bring these products to market while safeguarding research into the next generation of medical advances.

For example, we are considering a provision that would exempt research and experimentation from infringement liability.  This type of exception is common around the world.  It would allow basic research to continue unimpeded by patents, which are designed to control commercialization, not stifle research.  We will be reviewing any additional suggestions we receive that would promote research without discouraging product development.

The latter idea is one that has been suggested before, and has the advantage of taking some of the force from the argument (always more as a possibility than reality; see "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate") that basic research would be negatively impacted by permitting life sciences inventions to be patented.

Finally in the "lessons we have learned" section, the Senators mention that the alternative to fixing the patent subject matter eligibility pickle recent events have conspired to create will be to cloud inventions important to human health and diagnostics in trade secrecy -- a real risk with real consequences.

The Senators then set out the next steps:  clarifying in statutory language exclusion of human genes, and identifying the meaning of the "field of technology" requirement, so that "critical advances like artificial intelligence and medical diagnostics qualify, but not economic transactions or social interactions."

How these efforts go forward are important to track, because the Senators state that "[w]e will also consider ideas for reinforcing Section 112 of the Patent Act, which should operate to prevent inventors from claiming all possible solutions to a problem while also serving to protect inventors against those seeking to profit on trivial modifications."  There is much possible mischief in that statement, but these Senators are due the benefit of the doubt (and time) to fully flesh out how they intend to use Section 112 to address issues that have arisen (and have been imperfectly addressed) under Section 101.

Senators Tillis and Coons Release Statement on Recent Patent Reform Hearings

By Michael Borella --

As we have previously covered, the Senate Subcommittee on Intellectual Property recently held hearings on proposed revisions to 35 U.S.C. § 101 and related sections of the patent statute.  Chairman Thom Tillis (a Republican from North Carolina) and Ranking Member Chris Coons (a Democrat from Delaware) heard testimony from 45 individuals earlier this month.  These witnesses, including industry executives and groups, inventors, a former Federal Circuit judge, former USPTO officials, and law professors, discussed the pros and cons of the senators' proposal.  The purpose of the revisions and the hearings was to address the series of Supreme Court decisions in the last decade (most recently Alice Corp. v. CLS Bank Int'l) that has made it more difficult to obtain patents on certain types of inventions, most notably those related to software, business methods, and life sciences.

The Senators introduced a draft bill that eliminates the current two-part Supreme Court § 101 test, removes judicial exceptions to eligibility, draws a strict line between the inquiries of §§ 101, 102, 103, and 112, and would result in virtually any invention that "provides specific and practical utility in any field of technology through human intervention" being eligible.  The draft bill also changes § 112(f) in a fashion that narrows the interpretation of functional claim language.

On June 24, Senators Tillis and Coons released a statement regarding their takeaway from the hearings.  If anything, it reflects an understanding that the law needs to change, the Senators are committed to doing so, and that they are still working out some of the details.

The statement unequivocally acknowledges that there is a problem:

The hearings reinforced what we've been hearing for years — the U.S. patent system with regard to patent eligibility is broken and desperately needs to be repaired.  The U.S. Supreme Court has confused and narrowed Section 101 of the Patent Act to the point that investors are reluctant to pursue the innovations that propel our country forward.  We heard about studies showing that investors familiar with the current lack of clarity invest less in critical research and development in areas like medical diagnostics and artificial intelligence, at least in the United States.

The current director of the USPTO recently noted that inventors and judges alike struggle on a daily basis to determine "what is in and what is out" and wondered whether even Thomas Edison's famous phonograph patent would survive the courts' recent tests for eligible subject matter.

Likewise, two former USPTO directors testified to this disturbing lack of clarity, and the former chief judge of the U.S. Court of Appeals for the Federal Circuit characterized patent eligibility as "the number one problem in our patent system today."  He noted that, despite having personally drafted over 800 patent opinions, he struggled to predict the results in any given case.  His view is shared by current Federal Circuit judges, one of whom recently wrote that the lack of clarity in the law made it "near impossible to know with any certainty whether the invention is or is not patent eligible."

Given that, the Senators note that the Supreme Court has had ample opportunity to clarify the law, but has denied over 40 petitions for certiorari regarding § 101 since the Alice decision came down.  Thus, Senators Tillis and Coons have concluded that the ball is in Congress's court.

But reform will not be easy.  The Senators acknowledge that some witnesses like the state of § 101 as it is and the draft bill could open up areas of patenting that some suggest should be verboten.  But they are adamant that this will not derail their efforts:

Not everyone agrees that reform is needed.  Some witnesses cautioned that the status quo provides a mechanism to terminate baseless patent infringement lawsuits quickly and efficiently.  We hear these concerns, and we invite suggestions to mitigate them.  We cannot permit the courts, however, to destabilize our patent system for the sake of deterring nuisance litigation.  We can consider legislative provisions directly targeting the behavior of bad actors, and we welcome additional feedback on this point.

Several witnesses urged us not to permit patenting of scientific research per se, mere abstract ideas and nontechnical methods of doing business.  It is not our intent to do so.  To be clear, our patent system was never intended to protect artistic creations, methods of investing, or items found in nature.  Our framework attempts to provide a positive definition of eligibility to focus courts on subject matter that is eligible while eliminating the confusing and unreliable judicially created tests that dissect patent claims looking for "abstract ideas" and "inventive concepts."

Notably, the Senators signal that they are looking for ways to address nuisance litigation that does not involve the throwing-out-the-baby-with-the-bathwater approach of Alice, where legitimate technical and scientific advances are as easily invalidated as broad, vague claims with questionable novelty.  Furthermore, Senators Tillis and Coons write "we proposed amendments to other portions of the Patent Act to guard against the types of overly broad, functional patent claims frequently cited by those concerned about abuse."  This is a reference to the proposed changes to §§ 100 and 112(f), both of which promise to simplify the § 101 inquiry by taking on some of its baggage.  But the danger in doing so is that it may be difficult to limit functional claiming without enabling "those seeking to profit on trivial modifications" to a claimed invention.

The Senators also cast the need for § 101 reform as a matter of American competitiveness and national security.  Senators Tillis and Coons echo several witnesses when they decry "the uncertainty surrounding patent eligibility is affecting the development of technologies like 5G, quantum computing and artificial intelligence — innovations that not only promise to make life better for Americans, but also to protect our national security."  Implicitly referencing studies that some emerging technologies are much easier to patent in other countries, the Senators state that "inventions like these are receiving patents in Europe and China, but not in the United States."

The trick here is where to draw the line on patentability.  The dichotomy between inventions directed to "business" or "abstract" concepts and those that are "technical" is often false.  If the Senators propose a ban on business methods in the next iteration of the bill, does that include packet processing accelerators for financial transactions or innovative user interfaces for traders?  While both of these hypothetical inventions might have a business-oriented goal, they also rely on technological advances for their very existence and may involve groundbreaking ways of solving respective problems.  And what about artificial intelligence?  Looking from one angle, it is a pile of complex, abstract mathematics.  But from another angle, human ingenuity has recognized how to use these inherent mathematical properties in clever combinations to obtain results not otherwise attainable by humans or computers.

Building a wall between what is too abstract / business-oriented and what is patentable will be challenging, and may need to be taken on a case-by-case basis.  But the Alice test's attempt to do so resulted in an inquiry so vague and subjective that straight-faced arguments could be made for both the eligibility and the ineligibility of virtually any invention in which software takes a leading role.

Furthermore, any categorical exclusion to patentability needs to be tempered with the understanding that we do not know where the next great scientific and technical advances are coming from or what they will look like.  By definition, one cannot put a fence around innovation because inventiveness requires drawing outside the lines.

Clearly, Senators Tillis and Coons have some work to do, and codifying a softer variation of Alice may send reform efforts down a rat-hole.

Thus, while reaffirming the subcommittee's interest in § 101 reform, the statement in and of itself does not move the ball forward in a substantive fashion.  We will need to wait for the next version of the bill, which the Senators have previously indicated that they hope to have ready by the end of summer.  In the meantime, the statement asks repeatedly for feedback on the current draft and suggestions for its successor.  Serious proposals for addressing abusive litigation outside the ambit of § 101, a balanced approach to software patents, and how to define the scope of functional claims will almost certainly be welcome.