Patent Docs

IPO Webinar on Inter Partes Review

March 7, 2014

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Inter Partes Review: Nuts & Bolts" on March 13, 2014 beginning at 2:00 pm (ET). A panel consisting of R. Danny Huntington of Rothwell, Figg, Ernst & Manbeck, P.C.; Lori Gordon of Sterne, Kessler, Goldstein & Fox P.L.L.C.; and Judge Michael Tierney of the U.S. Patent and Trademark Office will discuss the PTAB's published guidance and suggested practice regarding:

• Patent owner motions to amend claims
• Motions to exclude the other side’s evidence
• Effective use of declarations and experts
• Deposition etiquette
• The one-year bar
• Joinder practice

The registration fee for the webinar is $130 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Webcast on Patent Law Treaty

March 7, 2014

West LegalEdcenter will be offering a live webcast entitled "Understanding the New USPTO Final and Proposed Rules on PLT and the Hague Agreement" on March 13, 2014 from 12:00 to 1:00 pm (EDT). Miku H. Mehta and Michael C. Jones of Procopio, Cory, Hargreaves & Savitch LLP will discuss the changes and the law and the proposed and actual rules, as well as how these rules impact prosecution generally with regard to the PLT provisions, and with respect to Hague, will consider the impact on design patent prosecution. The panel will also take a practical view and offer strategy tips.

The registration fee for the webcast is $195. Those interested in registering for the webinar, can do so here.
European Biotech Patent Law Webinar

March 7, 2014

D Young & Co will be offering its next European biotech patent law update on April 23, 2014. The 45-minute webinar will be offered at three times: 4:00 am, 7:00 am, and 12:00 pm (ET). D Young & Co European Patent Attorneys Robert Dempster and Simon O'Brien will provide an essential update and live Q&A on EPO biotechnology case law.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here.
Webinar on Data Privacy and Impact on U.S. Litigation

March 7, 2014

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Big Data Litigation in an Era of Big Data Privacy Concerns: Recent Developments in International Data Privacy Law and Their Impact on U.S. Litigation" on March 25, 2014 from 10:00 am to 11:15 am (CT). MBHB attorney S. Richard Carden will review recent developments in data privacy law worldwide (focusing primarily on the Asia-Pacific and Latin American regions), and discuss the impacts of those developments on U.S. litigation.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.
Amicus Briefs Urging Reversal Filed in Ariosa Inc v. Sequenom, Inc.

March 6, 2014

By Kevin E. Noonan —

The San Diego Intellectual Property Law Association (SDIPLA) is one of two groups that have filed an amicus curiae brief urging reversal of the District Court's summary judgment decision in Ariosa Inc v. Sequenom, Inc. (The brief from the other amicus, the Biotechnology Industry Organization, BIO, will be the subject of a future post.) The SDIPLA's position in its brief is not surprising (particularly in view of the violence with which the District Court treated established principles of patent law); what is surprising is that only two amici have shared their views with the Federal Circuit.

(In an unusual procedural aside, certain of the appellees refused to consent to these amicus filings, ostensibly because addressing the issues in the brief would require a 60-day extension of time for filing their responsive brief. The tactic worked, with the Federal Circuit granting the amici's motions for leave to file their briefs and appellees' motion for extension of time. Their responsive brief is now due May 5, 2014.)

Turning to the substance, the SDIPLA's brief poses three questions the Federal Circuit should address in the appeal:

1. Does a claim to a diagnostic use of a known process or known composition of matter that is statutorily patent eligible under 35 U.S.C. §101 become nonstatutory when the use is a new use of the known process or known composition of matter for the limited purpose of detection of a product of nature or natural phenomenon?

2. Is it relevant to the question of statutory patent eligibility of the claim of question 1 that the claimed process satisfies the machine-or-transformation test for statutory patent eligibility of a process?

3. Can a claim to a new diagnostic use of a known process or known composition of matter that is statutory patent eligible under 35 U.S.C. §101 be deemed preemptive of a product of nature or natural phenomenon when the new use of the known process or known composition of matter is limited to the detection of the product of nature or natural phenomenon?

In proposing answers to these questions, the amicus brief recites claim 1 of U.S. Patent No. 6,258,540 as being representative of the claims at issue:

A method for detecting a paternally inherited nucleic acid of fetal origin performed on a serum of plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

The brief argues that 35 U.S.C. § 100(b) expressly specifies that the term "process" used in § 101 encompasses "a new use of a known process, machine, manufacture, composition of matter, or material" (emphasis in brief). The claims at issue fall within the scope of this definition, being either a new use of a known process (amplification and detection of cffDNA) or a new use of an old composition of matter (naturally occurring cffDNA) (or both). The brief asserts that amplification and detection of DNA is patent eligible (assuming it could satisfy the other requirements of the statute); the brief cites the numerous patents granted to various aspects of in vitro amplification including, inter alia, U.S. Patent No. 4,683,195. The brief also argues (with less force) that plasma or serum would also be patent eligible; in a footnote the amicus notes that plasma and serum must be separated "by the intervention of man" and that plasma and serum have properties that differ from blood, thus satisfying the requirements of Diamond v. Chakrabarty not disturbed by either Mayo v. Prometheus or AMP v. Myriad. However, the brief makes the more interesting argument that, following the District Court's reasoning, claims to amplifying and detecting DNA that are patent eligible become less patent eligible when narrowed to a specific application of the technology (here, detecting cffDNA). Established patent law would be "eviscerated if a diagnostic process which, when broadly claimed, would be patent eligible if the requirements of novelty and unobviousness were satisfied becomes ineligible for patenting when narrowed if that narrowing involves applying the process to the new use of detecting a hitherto unknown product of nature or natural phenomenon, in this case the presence of cffDNA of paternal origin in maternal blood."

Amicus also argues that the claims of the '540 patent satisfy the "machine or transformation" test, which the brief argues is "a useful and important clue . . . for determining whether some claimed inventions are processes under §101," citing Bilski v. Kappos. The "substantial manipulation" required in the practice of the invention likewise provide "yet further clues to the patentability of the claims" and "justify[] recognition of the patent eligibility of the '540 patent claims."

The tension between the Supreme Court's Mayo decision and its earlier Diamond v. Diehr precedent is recited by the brief with regard to "the rigid application of the language of [Parker v.] Flook and Mayo which'"stands in stark contrast to the observation in Diamond v. Diehr [] that '[it] is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be patentable.'"

The brief then walks through earlier Supreme Court precedent related to the patent eligibility of process claims. These include Cochrane v. Deener (which the brief cites as the first decision recognizing that a new process can be patent eligible even if "not limited to any special arrangement of machinery"); Funk Bros. Seed Co. v. Kalo Inoculant Co. (which the brief distinguishes from the claims at issue because the '540 patentees "did not seek to patent this phenomenon but instead patented a process which, as the record in this case clearly reflects and the District Court acknowledges, takes advantage of the knowledge of that natural phenomenon by applying it to a new and very useful end, the detection of a cffDNA of paternal origin in the maternal blood" and noted that even the Funk Bros. Court recognized that claims to applications of natural phenomena were patent eligible); and Diehr. In particular, the brief cites the portion of the Myriad decision where Justice Thomas noted with approval the patent eligibility of applications of the patentees' knowledge of the BRCA genes and the relationship of mutations in those genes to an increase propensity for developing cancer. And the brief distinguishes the claims at issue from the claims invalidated by the Supreme Court in Mayo, on the grounds that nothing in the claims at issue in Mayo other than the natural law was inventive and in fact was well known and extensively practiced in the prior art.

These arguments lead this amicus to propose a rule, that "a process claim which is directed to a new diagnostic use of a known process and/or known composition of matter that are otherwise eligible for patenting under §101 be itself considered patent eligible in the circumstance where the diagnosis is specifically directed to the detection of a previously unknown natural product or natural phenomenon of diagnostic significance." The predicted consequence is that "[a]doption of such a standard of patent eligibility will also do much to further and incentivize innovation to discover and exploit new diagnostic tools without restricting other applications of the product of nature or natural phenomenon such innovation reveals, all of which is to the substantial benefit of the public."
Senate Legislation Update — The Commerce Committee Gets in the Act

March 5, 2014

By Andrew Williams —

\ Last Thursday, Sen. McCaskill, along with Sen. Rockefeller, introduced the "Transparency in Assertion of Patents Act" (S. 2049). Of course, several other bills are currently pending in the Senate that have been introduced by such politicians as Sen. Leahy (S. 1720), Sen. Hatch (S. 1612), Sen. Cornyn (S. 1013), and Sen. Schumer (S. 866). What sets the current bill apart is that it was referred to the Committee of Commerce, Science, and Transportation instead of the Judiciary committee. This may be due, in part, to the fact that the McCaskill bill is directed exclusively to abusive demand letters, with enforcement provisions directed to the Federal Trade Commission ("FTC"). However, the Leahy bill also contains a demand-letter provision, and also provides the FTC with enforcement power. It will therefore be interesting to monitor this newly introduced bill to see how it will be reconciled, if at all, with the other pending Senate bills. The McCaskill bill was scheduled for mark-up today, March 5, 2014, but that was postponed, likely until next week.

Of course, the difficulty with any bill aimed at the sending of demand letters is that the First Amendment rights of patent holders need to be taken into account. Congress cannot simply make the practice of sending such letters, without more, a judicial cause of action. More importantly, the sending of such demand letters is an essential part of our patent system, allowing patent holders to put alleged infringers on notice and, ideally, facilitating licensing activity between the parties. Care must be taken, therefore, to ensure that legitimate, non-abusive demand letters are not negatively impacted by any legislation.

On the other hand, curbing abusive demand letters is one of the only new legislative proposals that would impact pre-litigation activity. Such controls are essential, the anti-troll activists advocate, because many so-called "trolls" never end up in a courtroom. Instead, the argument goes, their main objective is to "shake-down" as many companies and individuals as possible, obtaining quick settlements because accused infringers are motivated to avoid costly litigation. If true, then some legislation impacting demand letters should be necessary if the "patent troll" problem is truly going to be addressed.

The Innovation Act, passed by the House last December, struck an appropriate balance. It was first made clear that the "Sense of Congress" was that the sending of purposely evasive demand letters was an abuse of the patent system. Importantly, the redress was narrowly tailored to the perceived problem. If a patent holder is found to have omitted certain essential facts from a demand letter, including the asserted patent and accused instrumentality, that same party could not rely on the demand letter as evidence in a willful infringement charge. In other words, if the letter does not put the accused infringer on notice, it cannot be relied upon to establish that they had actual knowledge of the patent or that they might be infringing the patent.

The Patent Transparency and Improvements Act (S. 1720), introduced by Sen. Leahy et al., takes a different tack, providing that "[i]t shall be an unfair or deceptive act or practice within the meaning of section 5(a)(1) of the Federal Trade Commission Act (15 U.S.C. 45(a)(1))" to engage in the abusive dissemination of demand letters. Specifically, it will be considered abusive if the patent holder (1) falsely threatens administrative or judicial relief, (2) the assertions lack a reasonable basis in fact or law, or (3) the content is likely to materially mislead a reasonable recipient. However, just what constitutes a threat remains unclear. It appears that Sen. Leahy had identified a particular "troll-like" behavior that he wanted to curb, but his proposed solution could end up impacting the legitimate assertion of patent rights.

Sen. McCaskill's bill is very similar to the provision in S. 1720. First, the bill would require the FTC to "promulgate rules to prohibit unfair or deceptive acts and practices" in the abusive sending of demand letters. The actions that would constitute unfair or deceptive assertion are the same as in the Leahy bill. However, the McCaskill bill outlines just what information a demand letter should contain: (1) each patent and asserted claim; (2) a detailed description of the accused instrumentality; (3) a detailed description of the alleged activity; (4) notice that the recipient has the right to have the manufacturer defend against the alleged infringement; (5) information about any party with a direct financial interest related to the assertion of the patent; (6) any licensing commitments; (7) any methodology used to calculate compensation; (8) any activity of the patent at the Patent Office or in court; and (9) anything else the FTC deems necessary. McCaskill's bill, much like the Leahy bill, would provide enforcement power to the FTC. However, her bill goes beyond the Leahy equivalent in providing for enforcement power by the states' attorneys general on behalf of their residents, should it be determined that the citizens of that state are falling victim to such abusive activity. The bill would provide for a civil penalty not to exceed $16,000 (adjusted for inflation) per violation of this rule. The FTC would be able to intervene, and a state could not bring such an action if the FTC has already instituted a civil action. The acknowledgement of the state attorneys general by the McCaskill bill is interesting, especially in view of their recent activity in states such as Vermont and Nebraska.

We will continue to monitor the situation in the Senate. Sen. Leahy recently reported that he would like to schedule the mark-up for next month, but it will likely not occur until May. It will be interesting to see how these two bills are rectified, or to see to what extent the two committees cooperate on passage of demand letter reform.
USPTO Issues Guidance for Analyzing Subject Matter Eligibility of Claims Reciting Laws of Nature/Natural Principles, Natural Phenomena or Natural Products

March 4, 2014

By Donald Zuhn —

Earlier today, in a memorandum issued to the Patent Examining Corps by Deputy Commissioner for Patent Examination Policy Andrew Hirshfeld, the U.S. Patent and Trademark Office implemented a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012). The guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance" as the file is named), indicates that "all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products should be examined using the Guidance" (emphasis in memo), and that the Myriad-Mayo Guidance is effective as of today and supersedes the Office's preliminary guidance on the Myriad decision that was issued on June 13, 2013 (see "USPTO Issues Memo on AMP v. Myriad to Examining Corps"). The memo does not specifically indicate whether the new procedure outlined in the Myriad-Mayo Guidance also supersedes the "2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature" (see "USPTO Issues Interim Guidance Regarding Mayo v. Prometheus"). The memo does note, however, that the new procedure outlined in the Myriad-Mayo Guidance does not impact the examination of claims reciting an abstract idea, which will continue to be analyzed using the guidance set forth in MPEP § 2106(II).

Before outlining the new procedure for assessing subject matter eligibility, the memo explains that the guidance addresses the impact of the Myriad decision on the Supreme Court's long-standing "rule against patents on naturally occurring things," as expressed in the Court's decisions in Diamond v. Chakrabarty and Mayo. The Myriad-Mayo Guidance notes that:

Myriad relied on Chakrabarty as "central" to the eligibility inquiry, and re-affirmed the Office's reliance on Chakrabarty's criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products). [Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107,] 2116-17. Myriad also clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., "isolated") in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not "depend simply on the draftsman's art"). Thus, while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.

(emphasis in original).

The new procedure described in the Myriad-Mayo Guidance involves a three-step analysis in which examiners are to ask the following questions:

1. Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?

2. Does the claim recite or involve one or more judicial exceptions?

3. Does the claim as a whole recite something significantly different than the judicial exception(s)?

This analysis is depicted in the memo using the following flowchart (click on flowchart to enlarge):

With regard to whether an examiner should proceed from the second question to the third question, the Myriad-Mayo Guidance states that:

Judicial exceptions include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products. In particular, claimed subject matter that must be analyzed under Question 3 to determine whether it is a natural product includes, but is not limited to: chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature.

If there is any doubt as to whether the claim recites a judicial exception (e.g., the claim recites something similar to a natural product), the claim requires further analysis under Question 3.

(emphasis in original).

The second part of the memo concerns the analysis of whether the claim recites something significantly different than a judicial exception. The Myriad-Mayo Guidance indicates that:

A significant difference can be shown in multiple ways, such as: (1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature (and thus not a judicial exception).

The memo then lists a dozen factors: six that weigh toward eligibility (i.e., the claim recites something that is significantly different from a judicial exception) and six that weigh against eligibility (i.e., the claim recites something that is not significantly different from a judicial exception). Noting that two of the factors "concern the question of whether something that initially appears to be a natural product is in fact non-naturally occurring and markedly different from what exists in nature, i.e., from naturally occurring products," the memo explains that:

This question can be resolved by first identifying the differences between the recited product and naturally occurring products, and then evaluating whether the identified differences together rise to the level of a marked difference in structure. Not all differences rise to the level of marked differences, e.g., merely isolating a nucleic acid changes its structure (by breaking bonds) but that change does not create a marked difference in structure between the isolated nucleic acid and its naturally occurring counterpart.

(emphasis in original; citation omitted).

The Myriad-Mayo Guidance further explains that "[t]he fact that a marked difference came about as a result of routine activity or via human manipulation of natural processes does not prevent the marked difference from weighing in favor of patent eligibility," citing Myriad for the proposition that "cDNA having a nucleotide sequence that is markedly different from naturally occurring DNA is eligible subject matter, even though the process of making cDNA is routine in the biotechnology art."

In the third part of the Myriad-Mayo Guidance, which covers almost thirteen of the memo's nineteen pages, the Office applies the memo's new analytic framework to eight examples:

A. Composition/Manufacture Claim Reciting A Natural Product
B. Composition vs. Method Claims, Each Reciting A Natural Product
C. Manufacture Claim Reciting Natural Products
D. Composition Claim Reciting Multiple Natural Products
E. Composition vs. Method Claims, Each Reciting Two Natural Products
F. Process Claim Involving A Natural Principle And Reciting Natural Products
G. Process Claims Involving A Natural Principle
H. Process Claim Reciting An Abstract Idea And A Natural Product

While practitioners are encouraged to thoroughly review the examples, the exemplary claims, subject matter eligibility determinations, and a brief summary of the rationales provided in the memo are listed below.

Example A:

Claim 1: A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.

Claim 2: A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

The memo finds claim 1 to be drawn to ineligible subject matter and claim 2 to be drawn to eligible subject matter, explaining that "although the plasmids themselves are natural products, in claim 2 the recited 'something that initially appears to be a natural product' . . . is the bacterium containing the plasmids, and not the bacterium alone or the plasmids alone." The memo notes that the bacterium of claim 2 was held to be patent-eligible subject matter in Chakrabarty.

Example B:

Claim 1: Purified amazonic acid.

Claim 2: Purified 5-methyl amazonic acid.

Claim 3: A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

The memo finds claim 1 to be drawn to ineligible subject matter and claims 2 and 3 to be drawn to eligible subject matter. With respect to claim 2, the memo states that "[t]he 5-methyl amazonic acid is structurally different than naturally occurring amazonic acid (because of the addition of the 5-methyl group), and this structural difference has resulted in a functional difference (5-methyl amazonic acid stimulates the growth of hair in addition to treating cancer)." More importantly, however, the memo indicates that "a functional difference is not necessary in order to find a marked difference," but suggests that "the presence of a functional difference resulting from the structural difference makes a stronger case that the structural difference is a marked difference." As for claim 3, the memo explains that "[t]he step of administering a particular dosage of amazonic acid (0.75 to 1.25 teaspoons per day) for a particular length of time (10-20 days) to a particular patient (patient with colon cancer), meaningfully limits the scope of the claim to a particular application of amazonic acid," and therefore "others are not substantially foreclosed from using amazonic acid in other ways, e.g., to treat colon cancer at other dosages or for other lengths of time, to treat other cancers, etc."

Example C:

Claim 1: A fountain-style firework comprising: (a) a sparking composition, (b) calcium chloride, (c) gunpowder, (d) a cardboard body having a first compartment containing the sparking composition and the calcium chloride and a second compartment containing the gunpowder, and (e) a plastic ignition fuse having one end extending into the second compartment and the other end extending out of the cardboard body.

The memo finds the claim to be drawn to eligible subject matter, explaining that "the claimed elements in addition to the calcium chloride and gunpowder narrow the scope of the claim so that others are not foreclosed from using the natural products in other ways, e.g., others can still use calcium chloride in products such as concrete, foods, fire extinguishers, etc., and can still use gunpowder in other products such as rifle cartridges."

Example D:

Claim 1: An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.

The memo finds the claim to be drawn to ineligible subject matter, explaining that "[t]he specification describes that applicant has not changed the bacteria in any way, but instead has simply combined various strains of naturally occurring bacteria together." The memo notes that the inoculant of this claim was held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948).

Example E:

Claim 1: A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2.

Claim 2: A method of amplifying a target DNA sequence comprising:
    providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of claim 1 wherein the first primer is complementary to a sequence on the first strand of the target DNA and the second primer is complementary to a sequence on the second strand of the target DNA, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine;
    heating the reaction mixture to a first predetermined temperature for a first predetermined time to separate the strands of the target DNA from each other;
    cooling the reaction mixture to a second predetermined temperature for a second predetermined time under conditions to allow the first and second primers to hybridize with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers; and
    repeating steps (b) and (c) at least 20 times.

The memo finds claim 1 to be drawn to ineligible subject matter and claim 2 to be drawn to eligible subject matter. With regard to claim 1, the memo notes that "neither of the natural products recited in the claim is markedly different," adding that "the first and second primers have the same function as their natural counterpart DNA, i.e., to hybridize to their complementary nucleotide sequences," and that "[t]he minor structural differences taken together with the lack of any functional difference between the primers and the natural DNA fail to demonstrate that the recited products are markedly different from what exists in nature." With respect to claim 2, the memo explains that "the heating and cooling steps contain a number of limitations that narrow the scope of the claim," and that "others can still apply and use the natural products in other methods, such as a method of treatment or even an amplification method that does not involve Taq polymerase or thermal cycling."

Example F:

Claim 1: A method for determining whether a human patient has degenerative disease X, comprising: obtaining a blood sample from a human patient; determining whether misfolded protein ABC is present in the blood sample, wherein said determining is
    performed by contacting the blood sample with antibody XYZ and detecting whether binding occurs between misfolded protein ABC and antibody XYZ using flow cytometry, wherein antibody XYZ binds to an epitope that is present on misfolded protein ABC but not on normal protein ABC; and
    diagnosing the patient as having degenerative disease X if misfolded protein ABC was determined to be present in the blood sample.

The memo finds claim 1 to be drawn to eligible subject matter, noting that "[a] review of the specification indicates that antibody XYZ does not exist in nature, and is not purely conventional or routine in the art (it was newly created by the inventors)," and explaining that "others can still apply and use the natural principle in other methods, such as a method of treatment or a method of assessing whether a particular treatment regimen has resulted in a decrease in the amount of misfolded protein ABC in a patient's blood."

Example G:

Claim 1: A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to sunlight, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

Claim 2: A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to a synthetic source of white light, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

Claim 3: A method for treating a mood disorder in a human patient, the mood disorder associated with
    neuronal activity in the patient’s brain, comprising: providing a light source that emits white light; filtering the ultra-violet (UV) rays from the white light; and positioning the patient adjacent to the light source at a distance between 30-60 cm for a
    predetermined period ranging from 30-60 minutes to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

The memo finds claims 1 and 2 to be drawn to ineligible subject matter and claim 3 to be drawn to eligible subject matter. With respect to claim 1, the memo explains that "the only step in addition to the judicial exceptions is the step of exposing a patient to sunlight, and this step is not a meaningful limit on the claim scope, in that it substantially forecloses others from using or applying sunlight (a natural phenomenon) alone or in connection with the natural principle." According to the memo, claim 2 is directed to patent ineligible subject matter, in part because "the step of exposing a patient to synthetic white light for the purpose of affecting a mood disorder is just an attempt to limit the use of the natural principle to a particular technological environment (use of artificial light as opposed to sunlight)." Finally, with respect to claim 3, the memo notes that "the filtering and positioning steps meaningfully limit the claim to a particular application of the natural principle," and that "[o]thers are not substantially foreclosed from using or applying the natural principle in other ways, e.g., by exposing a patient to sunlight, by positioning the patient for a different length of time or at a different distance, etc."

Example H:

Claim 1: A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

The memo indicates that "[b]ecause the claim recites an abstract idea, Question 3 should be analyzed using only the existing guidance in MPEP § 2106(II)." The memo also notes that claim 1 was found to be directed to ineligible subject matter in Association for Molecular Pathology v. Myriad Genetics, Inc., 689 F.3d 1303, 1333-35 (Fed. Cir. 2012), aff’d in part and rev’d in part on other grounds, 569 U.S. __, 133 S. Ct. 2107, 2116 (2013).
Cyberfone Systems, LLC v. CNN Interactive Group, Inc. (Fed. Cir. 2014)

March 3, 2014

By Michael Borella —

In 2011, Cyberfone sued CNN and 80 other defendants in the U.S. District Court for the District of Delaware for infringement of U.S. Patent No. 8,019,060. On the defendants' motion for summary judgment, the District Court held the claims of the '060 patent invalid under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter. In a non-precedential ruling, the Federal Circuit panel of Judges Lourie, Dyk, and Wallach affirmed.

Claim 1 of the '060 patent recites:

A method, comprising:
    obtaining data transaction information entered on a telephone from a single transmission from said telephone;
    forming a plurality of different exploded data transactions for the single transmission, said plurality of different exploded data transactions indicative of a single data transaction, each of said exploded data transactions having different data that is intended for a different destination that is included as part of the exploded data transactions, and each of said exploded data transactions formed based on said data transaction information from said single transmission, so that different data from the single data transmission is separated and sent to different destinations; and
    sending said different exploded data transactions over a channel to said different destinations, all based on said data transaction information entered in said single transmission.

After dispensing with the usual overview of § 101 case law, Judge Dyk, writing for the panel, applied the two-step analysis of Mayo v. Prometheus. First, he concluded that claim 1 involves an abstract idea. He characterized this abstract idea as "collecting information in classified form, then separating and transmitting that information according to its classification." Next, he examined the remaining limitations of claim 1 to determine whether "additional substantive limitations . . . narrow, confine, or otherwise tie down the claim so that, in practical terms, it does not cover the full abstract idea itself."

In its defense, Cyberfone asserted that claim 1 meets both prongs of the machine or transformation test of Bilski v. Kappos, and therefore meets the requirements of § 101 for this reason. Particularly, Cyberfone took the position that claim 1 requires a telephone, contending that it is a specific machine integral to the claimed method. However, in line with reasoning of several Federal Circuit judges, Judge Dyk warned that "[f]or a machine to impose a meaningful limit . . . it must play a significant part in permitting the claimed method to be performed [and] simply implementing an abstract concept on a computer, without meaningful limitations to that concept, does not transform a patent-ineligible claim into a patent-eligible one."

To determine whether the claimed telephone is indeed significant to the claim, Judge Dyk looked to the specification of the '060 patent. He focused on text that states that the invention relates to "a transaction entry device which can selectively operate in a telephone mode and a transaction entry mode." While in the telephone mode, "the transaction entry device operates as a conventional telephone," but in the transaction entry mode, "menus are used to navigate the user to forms which facilitate the entry of data." From this distinction, Judge Dyk concluded that "the telephone does not obtain data when it is functioning as a telephone, only when in an unclaimed mode of operation."

In contrast to Judge Dyk's conclusion, the '060 patent does not state that the telephone and transaction entry modes are mutually exclusive. Rather, at col. 6, line 53 through col. 7, line 14, the '060 patent describes how these modes can be used together. Particularly, the telephone mode requires use of a telephone line for telephony calling, while the transaction entry mode would also use such a telephone line for modem-based data transaction. However, the specification notes that "[i]n telephone mode, one or more lines may be connected so as to allow simultaneous use of the transaction entry device without interfering with the modem connection." Therefore, the '060 explicitly permits the telephone to obtain data when it is functioning as a telephone.

Furthermore, Judge Dyk stated that the obtaining of data is "an unclaimed mode of operation." Perplexingly, the first element of claim recites "obtaining data transaction information entered on a telephone."   Claim 1 goes on to recite how this data is processed and used. Therefore, it is unclear how Judge Dyk attained this interpretation of the claim, especially since the claim itself makes no mention of the device being in either mode. Does Judge Dyk's reasoning, taken to its logical extreme, mean that my cell phone is no longer a cell phone when I use the keypad to enter a number, but suddenly becomes one again when I press "send" to call that number?

Regardless, Judge Dyk went on to state that "the recited telephone can be a range of different machines: a conventional telephone, a portable telephone, [or] a battery operated portable device which is a cross between a laptop computer and a cellular telephone." (Citations omitted.) Based on these broad definitions of the term "telephone," Judge Dyk concluded that "[t]he telephone recited in claim 1 is not a specific machine, and adds nothing of significance to the claimed abstract idea." Cyberfone argued further that the claimed step of "sending said different exploded data transactions over a channel to said different destinations" required a specific machine, but Judge Dyk found this point unconvincing, asserting that "Cyberfone provides no guidance as to what particular machine is required to perform the function of the recited channel."

Finally, Cyberfone attempted to invoke the transformation prong of the machine or transformation test, in that the "exploded data transactions involve such a transformation." Judge Dyk, however, was skeptical, and stated that "the exploding step effects no meaningful transformation because it merely makes the originally-gathered information accessible to different destinations without changing the content or its classification. Nor does the particular configuration of steps — obtaining, separating, and then sending information — confer patentability."

For the second time in two months, the Federal Circuit has come down with a non-precedential opinion that serves to further illustrate the Court's position on § 101 and computer-implemented technologies (see Smartgene, Inc. v. Advanced Biological Laboratories, SA). In this case, the plain text of the specification appears to contradict the panel's reasoning. Perhaps the panel used uncited information in the record to reach its conclusion?

One factor that may have worked against Cyberfone is the structure of the claim. Claim 1 requires "obtaining data transaction information . . . from [a] telephone," and "sending . . . exploded data transactions over a channel to said different destinations." However, it is not clear which of these devices (the telephone or the destinations) performs the steps of the claim. In other words, claim 1 could be viewed as a disembodied method, perhaps one that could be performed by a human. In that light, the § 101 rejection of the claim has a stronger basis in precedent.

Regardless, patent drafters might find Judge Dyk's conclusion of the telephone not being a specific device troublesome. It is very common for the specification of a computing-related patent to define a "computing device" or a "communication device" to include embodiments such as a personal computer, tablet computer, cell phone, or any other type of computer with networking capabilities. This is done in order to provide a basis for arguing (e.g., in a Markman brief) that the term should be construed broadly. Will the Federal Circuit adopt the reasoning of this non-precedential opinion to hold such language against the applicant in § 101 analyses?

Cyberfone Systems, LLC v. CNN Interactive Group, Inc. (Fed. Cir. 2014)
Panel: Circuit Judges Lourie, Dyk, and Wallace
Opinion by Circuit Judge Dyk
Patent Profile: VM Institute of Research Receives Patent for Method of Treating Triple Negative Breast Cancer

March 2, 2014

By Josh Bosman —

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,642,270, which is entitled "Prognostic biomarkers to predict overall survival and metastatic disease in patients with triple negative breast cancer." The '270 patent, which is assigned to the VM Institute of Research (Montreal, Canada), contains claims to a method of treating breast cancer in a subject having triple negative breast cancer.

For some time doctors and scientists hypothesized that the diversity observed among breast tumors might be accompanied by diversity in gene expression patterns. Over ten years ago, Perou and colleagues published their work on the "Molecular portraits of human breast tumours" (Perou et al., 2000 Nature 406: 747-52) classifying human breast tumors based their gene expression profiles. This work was soon followed up with studies that linked the gene expression profiles of each breast cancer subtype with patient overall survival and disease free survival. One of the subtypes identified was the basal-like subtype. The basal-like subtype is also described as triple-negative breast cancer because it generally does not express estrogen receptor (ER), progesterone receptor (PR), and expresses only normal, but not amplified, levels of the human epidermal growth factor receptor 2 (HER2). Given the nature of the triple-negative breast tumors, this subtype does not respond to cancer drugs that target ER, PR or HER2 (i.e., Taxol® or Herceptin®), and has poorer overall survival and disease-free survival than other breast cancer subtypes. The triple negative paradox (Carey et al., 2007 Clin Cancer Res. 13(8): 2329-34) is that these tumors often respond well to the initial chemotherapy treatments, and yet patients have significantly poorer overall survival. The work by the inventors of the `270 patent helps to develop effective methods to determine whether a triple negative breast cancer patient is likely to have a recurrence or progress to the aggressive, metastatic disease in order to aid clinicians in deciding the appropriate course of treatment.

The '270 patent provides a method of treating breast cancer in a subject having a triple negative breast cancer. The inventors were able to identify a 12 gene set that correlates with overall survival of the triple negative breast tumors. More specifically, the inventors determined that the expression of STK3, KLF6, CD24 and KRAS, could be indicative of a recurrent triple negative breast tumor.

The '270 patent has one independent claim which recites:

1. A method of treating breast cancer in a subject having a triple negative (TN) breast cancer, the method consisting of the steps:
    (a) quantifying mRNA expression level of biomarkers STK3 and KLF6, and at least one biomarker selected from CD24 and KRAS in a test sample from a subject using a biological assay;
    (b) comparing said mRNA expression level of said biomarkers selected from STK3, KLF6, and at least one of CD24 and KRAS quantified in step (a) to the expression level of said biomarkers quantified using the biological assay in a standard sample indicative of a recurrent TN breast cancer; and
    (c) administering an aggressive cancer treatment regimen to the subject based on an increase in the expression level of the biomarkers between the standard sample and the test sample.

A review of the file history of the '270 patent indicates that a rejection under 35 U.S.C. § 101 rejection was issued in the first Office Action. The Action stated that the claimed invention is directed to non-statutory subject matter because it is not a patent-eligible practical application of a law of nature and because the claimed method does not result in a physical transformation of matter. Specifically, the Action asserted that the claims do not recite additional elements or steps such that the method is sufficient to ensure that the claim amounts to significantly more than the natural principle itself or merely more than mental tasks.

The original claim 1 as filed recited:

1. A method of predicting the overall survival (OS) potential of a triple negative (TN) breast cancer in a subject, the method comprising the step:
    (a) comparing expression level of at least one biomarker determined in a test sample from a subject to the expression level of the at least one biomarker in a standard sample indicative of a recurrent TN breast cancer, wherein the at least one biomarker is chosen from ANK3, CD24, EIF1, KLF6, KRAS, KRT1, MAP2K4, SDC4, SLC2A3, STK3, TFAP2C, and WRN; and wherein a difference in the expression level of the at least one biomarker between the standard sample and the test sample is used to predict the OS potential of the TN breast cancer in the subject.

In response, the Applicant amended claim 1 to introduce an additional step of modifying a treatment regimen of the subject based on the results of step (a). The Applicant asserted that with the new step, the method as amounted to "significantly more than the application of a natural principle."

Claim 1 as amended recited:

1. (Currently Amended) A method of predicting the overall survival (OS) potential of a triple negative (TN) breast cancer in a subject, the method comprising the step:
    (a) comparing a mRNA expression level of at least threeone biomarkers chosen from STK3, KLF6, and one of CD24 or KRAS determinedquantified using a biological assay in a test sample from a subject to the expression level of the at least threeone biomarkers quantified using the biological assay in a standard sample indicative of a recurrent TN breast cancer, wherein the at least one biomarker is chosen from ANK3, CD24, EIF1, KLF6, KRAS, KRT1, MAP2K4, SDC4, SLC2A3, STK3, TFAP2C, and WRN; and
    (b) modifying a treatment regimen of the subject based on the results of step (a) wherein a difference in the expression level of the at least one biomarkers between the standard sample and the test sample is used to predict the OS potential of the TN breast cancer in the subject.

In the next and final Office Action mailed July 30, 2013, the Office maintained the rejection of the claims under 35 U.S.C. § 101 because the invention was not a patent-eligible practical application of a law of nature. The Action noted that the claims recited methods steps for detecting or determining and comparing marker levels from samples, but asserted that these steps are routine or conventional, and do not add anything substantial to the claim that amounts to significantly more than observing the natural principle itself. Regarding the step of "modifying a treatment regimen," the Action stated that such a step can be "accomplished mentally by thinking or designing a new treatment plan, and does not set forth any physical steps."

Furthermore, in the final Office Action, the Examiner suggested "amending the claims to recite an active step of administering a specified treatment regimen based on specific results (specific results such as increased or decreased mRNA levels of STK3, KLF6, and CD24 or KRAS relative to specific controls) to a patient population identified by such specific results." Additionally, the Action stated that "prediction of survival rates as correlated to naturally occurring mRNA levels are considered an observation of a naturally occurring principle and an active step must be added to the claimed method that amounts to significantly more than the observation of the natural principle."

On September 17, 2013, in the response to the final Office Action, the Applicant stated "without conceding the correctness of the Examiner's position and for the purpose of expediting prosecution, Claim 1 has been amended to introduce an additional step (c), as suggested by the Examiner." Claim 1 was amended claim 1 as shown below:

1. (Currently Amended) A method of predicting the overall survival (OS) potential of a triple negative (TN) treating breast cancer in a subject having a triple negative (TN) breast cancer, the method comprisingconsisting of the steps:
    (a) quantifying mRNA expression levels of biomarkers STK3 and KLF6, and at least one biomarker selected from CD24 and KRAS in a test sample from a subject using a biological assay;
    (b) comparing [[a]]said mRNA expression level of at least three said biomarkers chosen selected from STK3, KLF6, and at least one of CD24 andor KRAS quantified in step (a) using a biological assay in a test sample from a subject to the expression level of said the at least three biomarkers quantified using the biological assay in a standard sample indicative of a recurrent TN breast cancer; and
    (c[[b]]) modifyingadministering an aggressive cancer treatment regimen ofto the subject based on the results of step (b[[a]]) wherein a difference an increase in the expression level of the biomarkers between the standard sample and the test sample is used to predict the OS potential of the TN breast cancer in the subject.

A notice of allowance was mailed on October 1, 2013.
Court Report

March 2, 2014

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Takeda Pharmaceuticals USA Inc. v. Watson Laboratories Inc. et al.
1:14-cv-00268; filed February 27, 2014 in the District Court of Delaware

• Plaintiff: Takeda Pharmaceuticals USA Inc.
• Defendants: Watson Laboratories Inc.; Actavis Inc.

Infringement of U.S Patent Nos. 7,619,004 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued November 17, 2009), 7,601,758 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics in the Treatment of Gout Flares," issued October 13, 2009), 7,820,681 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued October 26, 2010), 7,915,269 (same title, issued March 29, 2011), 7,964,647 ("Colchicine Compositions and Methods," issued June 21, 2011), 7,964,648 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued June 21, 2011), 7,981,938 ("Colchicine Compositions and Methods," issued July 19, 2011), 8,093,296 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued January 10, 2012), 8,093,297 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued January 10, 2012), 8,097,655 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued January 17, 2012), 8,415,395 ("Colchicine Compositions and Methods," issued April 9, 2013), 8,415,396 (same title, issued April 9, 2013), 8,440,721 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued May 14, 2013), and 8,440,722 (same title, issued May 14, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Takeda's Colcrys® (single-ingredient colchicine product, used to prevent and treat gout flares). View the complaint here.

Lyne Laboratories, Inc. et al. v. Roxane Laboratories, Inc.
1:14-cv-10460; filed February 27, 2014 in the District Court of Massachusetts

• Plaintiffs: Lyne Laboratories, Inc.; Fresenius USA Manufacturing, Inc.; Fresenius Medical Care Holdings, Inc.
• Defendant: Roxane Laboratories, Inc.

Infringement of U.S. Patent Nos. 8,591,938 ("Liquid Compositions of Calcium Acetate," issued November 26, 2013) and 8,592,480 (same title, issued November 26, 2013) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Fesenius' Phoslyra® (calcium acetate oral solution, used as a phosphate binder for the reduction of serum phosphorus in patients with end stage renal disease). View the complaint here.

Sanofi et al. v. Glenmark Generics Inc. USA et al.
1:14-cv-00264; filed February 26, 2014 in the District Court of Delaware

• Plaintiffs: Sanofi; Sanofi-Aventis U.S. LLC
• Defendants: Glenmark Generics Inc. USA; Glenmark Generics Ltd.

Sanofi et al. v. Watson Laboratories Inc. et al.
1:14-cv-00265; filed February 26, 2014 in the District Court of Delaware

• Plaintiffs: Sanofi; Sanofi-Aventis U.S. LLC
• Defendants: Watson Laboratories Inc.; Watson Pharma Inc.; Actavis Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,318,800 ("Solid Pharmaceutical Compositions Containing Benzofuran Derivatives," issued November 27, 2012), 8,410,167 ("Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or of Mortality," issued April 2, 2013), and 8,602,215 ("Methods for Reducing the Risk of an Adverse Dronedarone/Beta-Blockers Interaction in a Patient Suffering from Atrial Fibrillation," issued December 10, 2013 following a Paragraph IV certification as part of defendats' filing of an ANDA to manufacture a generic version of Sanofi's Multaq® (dronedarone, used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation). View the Glenmark complaint here.

Meda Pharmaceuticals Inc. v. Perrigo Israel Pharmaceutical Ltd. et al.
3:14-cv-01241; filed February 25, 2014 in the District Court of New Jersey

• Plaintiff: Meda Pharmaceuticals Inc.
• Defendants: Perrigo Israel Pharmaceutical Ltd.; Perrigo Company; L. Perrigo Co.; Impax Laboratories, Inc.

Infringement of U.S. Patent No. 8,518,919 ("Compositions Comprising Azelastine and Methods of Use Thereof," issued August 27, 2013) following a Paragraph IV certification as part of defendats' filing of an ANDA to manufacture a generic version of Meda's Astepro® (azelastine hydrochloride nasal spray, used to treat hay fever and allergy symptoms). View the complaint here.

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