Patent Docs

Happy Thanksgiving from Patent Docs

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 30th.

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 30th.

The authors and contributors of Patent Docs wish their readers and families a Happy Thanksgiving.  Publication of Patent Docs will resume on November 30th.

Pharma Tech Solutions, Inc. v. Lifescan, Inc. (Fed. Cir. 2019)

By Kevin E. Noonan --

"Everything you say can be held against you" is a trope in crime shows from the U.S., Australia, New Zealand, the UK, and Ireland (stated in various ways), and a recent decision by the Federal Circuit regarding preclusion of infringement under the doctrine of equivalents by prosecution history estoppel is an excellent example of the same principle in patent law.

The lawsuit that gave rise to the Court's decision in Pharma Tech Solutions, Inc. v. Lifescan, Inc. involved Pharma Tech's assertion of U.S. Patent Nos. 6,153,069 and 6,413,411, which were directed to blood glucose monitoring systems.  As explained in the opinion:

To test blood glucose, an individual typically draws blood by pricking a finger, placing the blood on the end of a test strip, and placing the test strip into a meter.  The test strip contains a pair of electrodes, including a working electrode and a second electrode.  The working electrode is coated with an enzyme that oxidizes glucose in the blood sample.  Following an incubation period, the meter (1) applies a known electric potential across the electrodes, creating a diffusion limiting electric current (referred to as the "Cottrell current") through the sample; and (2) measures Cottrell current.  A proportional relationship exists between the measured current and blood glucose concentration.  Based on this proportional relationship, a microprocessor in the meter converts the measured electric current to a blood glucose level and then reports the blood glucose level to the user.

The distinction from prior art monitoring systems embodied in the claims is illustrated by the italicized portion of claim 1 of the '069 patent:

1.  An apparatus for measuring compounds in a sample fluid, comprising:
    a) a housing having an access opening therethrough;
    b) a sample cell receivable into said access opening of said housing, said sample cell being composed of;
        (i) a first electrode which acts as a working electrode;
        (ii) a second electrode which acts to fix the system potential and provide opposing current flow with respect to said first electrode, said second electrode being made of the same electrically conducting material as said first electrode, and being operatively associated with said first electrode, the ratio of the surface area of said second electrode to the surface area of said first electrode being 1:1 or less;
        (iii) at least one non-conducting layer member having an opening therethrough, said at least one non-conducting layer member being disposed in contact with at least one of said first and second electrodes and being sealed against at least one of said first and second electrodes to form a known electrode area within said opening such that said opening forms a well to receive the sample fluid and to allow a user of said apparatus to place the sample fluid in said known electrode area in contact with said first electrode and said second electrode;
    c) means for applying an electrical potential to both said first electrode and said second electrode;
    d) means for creating an electrical circuit between said first electrode and said second electrode through the sample fluid;
    e) means for measuring a first Cottrell current reading through the sample fluid at a first predetermined time after the electrical potential is applied and for obtaining at least one additional Cottrell current reading through the sample fluid, the at least one additional Cottrell current reading occurring at a second predetermined time following the first predetermined time;
    f) microprocessor means for converting the first Cottrell current reading into a first analyte concentration measurement using a calibration slope and an intercept specific for the first Cottrell current measurement, for converting the at least one additional Cottrell current reading into an additional analyte concentration using a calibration slope and an intercept specific for the at least one additional Cottrell current measurement, and for comparing the first analyte concentration measurement with the at least one additional concentration measurement to confirm that they are within a prescribed percentage of each other; and
    g) means for visually displaying the results of said analyte concentration measurements.

Thus, rather than measuring the induced Cottrell current readings and comparing them, the microprocessor converts these current readings to glucose concentrations and compares them.

Lifescan's accursed infringing article, sold as the OneTouch® Ultra® system, operates by measuring current produced in the presence of blood on the test strip in two working electrodes during a five-second "countdown period," and then conducts a "Current Difference Test" (as a control that the values are within proscribed limits), followed by calculating total final current (that is then correlated with blood glucose concentration).  As stated in the opinion:

It is undisputed that Lifescan's meters neither convert multiple Cottrell current readings to analyte concentration measurements nor compare multiple analyte concentration measurements.  Pharma Tech agrees that the accused products therefore do not literally infringe the claim.  But Pharma Tech asserts that "an analyte measurement can be expressed as a current at a given time or as a concentration" and, thus, the accused device infringes under the doctrine of equivalents.

The opinion sets forth certain aspects of the prosecution history, wherein the italicized portion of the claim set forth above was added by amendment in response to rejection over certain prior art references (specifically U.S. Patent No. 5,385,846 (Kuhn), U.S. Patent No. 5,288,636 (Pollmann), and U.S. Patent No. 5,108,564 (Szuminsky)).  These amendments were accompanied by argument, wherein the applicant relied on the feature of converting the Cottrell current readings to analyte (i.e., blood glucose) concentrations which were then compared with one another.  These amendments were not completely availing for patentability, because the Examiner asserted two additional prior art references (U.S. Patent No. 5,508,171 (Walling) and U.S. Patent No. 5,243,516 (White)) for obviousness, which the applicant distinguished based on the "converting" and "comparing" language introduced into the claims in the previously presented amendment.  After somewhat protracted argument along these lines, the applicant was finally able to have the '069 patent grant; the '411 patent granted shortly thereafter.

The District Court granted Life Scan summary judgment that prosecution history estoppel prevented Pharma Tech from showing infringement under the doctrine of equivalents (Pharma Tech dismissed its literal infringement claims).  In doing so, the Court held that both amendment-based and argument-based estoppel arose by Pharma Tech's amendments and arguments, and rejected plaintiff's argument that estoppel did not arise because the amendments and arguments were only tangentially related to patentability, pursuant to Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1369 (Fed. Cir. 2003). This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Stoll, joined by Judges Moore and Reyna.  The opinion sets forth the parameters of "amendment-based" estoppel (that the amendment was narrowing for purposes of establishing patentability over the prior art) and "argument-based" estoppel (surrender of claim scope by arguments made to the Patent Office), finding both species of estoppel on the record before it.  Under Festo, a presumption arises when an applicant submits a narrowing amendment to overcome a rejection for unpatentability.  That presumption can be overcome one of three ways, according to the Court:  "(1) the equivalent was "unforeseeable at the time of the application"; (2) "the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question"; or (3) "there may be some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question," citing Festo at 740-1.  Here, Pharma Tech argued tangentiality, unsuccessfully.

With regard to argument-based estoppel, "the prosecution history must evince a clear and unmistakable surrender of subject matter" according to the opinion, citing Conoco, Inc. v. Energy & Envtl. Int'l, L.C., 460 F.3d 1349, 1364 (Fed. Cir. 2006) (quoting Deering Precision Instruments, L.L.C. v. Vector Distribution Sys., Inc., 347 F.3d 1314, 1326 (Fed. Cir. 2003)).  The Court set forth the policy bases for this estoppel, stating that "[c]lear assertions made during prosecution in support of patentability, whether or not actually required to secure allowance of the claim, may also create an estoppel . . . because [t]he relevant inquiry is whether a competitor would reasonably believe that the applicant had surrendered the relevant subject matter," citing PODS, Inc. v. Porta Stor, Inc., 484 F.3d 1359, 1368 (Fed. Cir. 2007).

The Federal Circuit held that both types of estoppel precluded Pharma Tech from a finding of infringement under the doctrine of equivalents.  Regarding amendment-based estoppel, the opinion states that, prior to amendment Pharma Tech's claim "was broad enough to cover any bioelectrical blood glucose monitoring system" and afterwards, the claim was limited to systems that converted Cottrell current readings to analyte concentrations that were compared to one another.  Accordingly, "[t]he applicants thus presumptively surrendered any bioelectrical blood glucose monitoring systems that do not convert a plurality of current readings into analyte concentration measurements and compare the resulting analyte concentration measurements."  The "equivalent" asserted by Pharma Tech to ensnare Lifescan's accused infringing article -- "the functionality of a system that (a) measures current at two different times, (b) compares the current[s] to ensure they are within a prescribed percentage and (c) converts the current readings into a glucose concentration" -- "falls squarely within the territory between the original claim and the amended claim" in the panel's view.  In order for Pharma Tech to overcome the presumption that the amendments estopped them from (successfully) asserting this equivalent, its burden was to show that the amendment was only tangentially related to patentability.  Pharma Tech failed to make this showing, according to the opinion, because "the inventors clearly and unambiguously distinguished their invention over the prior art based on the converting and comparing limitations added by [their] amendment."  The opinion cites the "consistent[] assert[ions]" (expressly cited in the opinion) by the patent applicant that their amendment overcame the asserted prior art in support for their conclusion regarding amendment-based estoppel.  And to Pharma Tech's argument that their amendment (under the Court's reading) surrendered more claim scope than necessary to establish patentability, the opinion states that this doesn't establish tangentiality, citing Int'l Rectifier Corp. v. IXYS Corp., 515 F.3d 1353, 1359 (Fed. Cir. 2008) (quoting Schwarz Pharma, Inc. v. Paddock Labs., Inc., 504 F.3d 1371, 1377 (Fed. Cir. 2007)) that "'[t]he fact that the inventors may have thought after the fact that they could have relied on other distinctions in order to defend their claims is irrelevant' to discerning the objective reason for their amendment."

As for argument-based estoppel, the opinion states that Pharma Tech failed to show that the facts before the panel were sufficiently analogous to cases where the estoppel was not found to absolve these claims from this species of estoppel.  Specifically, the opinion rejects Pharma Tech's attempted reliance on Insituform Technologies, Inc. v. CAT Contracting, Inc., 385 F.3d 1360 (Fed. Cir. 2004).  In that case, the Federal Circuit was able to find that there was "no indication in the prosecution history of any relationship between the narrowing amendment" and the asserted equivalent.  Here, in contrast, the Court found ample evidence that the amendments and arguments had more than a tangential relationship to patentability.  Similarly, the panel distinguished these facts from the situations arising in recent Federal Circuit decisions regarding the scope of estoppel, including Eli Lilly & Co. v. Hospira, Inc., 933 F.3d 1320, 1332 (Fed. Cir. 2019) and Ajinomoto Co. v. Int'l Trade Comm'n, 932 F.3d 1342, 1355 (Fed. Cir. 2019).

The outcome here illustrates the difficulty (if not impossibility) of predicting future design-around efforts by others, and how prudent prosecution practices include maintaining pending applications to give a patentee the flexibility to pursue claims that will be literally infringed by even the most clever competitors.

Pharma Tech Solutions, Inc. v. Lifescan, Inc. (Fed. Cir. 2019)
Panel: Circuit Judges Moore, Reyna, and Stoll
Opinion by Circuit Judge Stoll

Merck Sharp & Dohme Corp. v. Wyeth LLC (Fed. Cir. 2019)

By Donald Zuhn --

Today, in Merck Sharp & Dohme Corp. v. Wyeth LLC, the Federal Circuit vacated and remanded two final written decisions by the U.S. Patent and Trademark Office Patent Trial and Appeal Board finding claim 18 of U.S. Patent No. 8,562,999 to be nonobvious.  The '999 patent, which is directed to formulations for stabilizing polysaccharide-protein conjugate vaccines, is assigned to Wyeth LLC.

Polysaccharide-protein conjugate vaccines are derived from capsular polysaccharides present on the surface of certain disease-causing bacteria.  These capsular polysaccharides can be used by the human immune system to detect different serotypes (or strains) of a bacterial species.  Polysaccharide vaccines can be monovalent (comprising a single serotype) or multivalent (comprising multiple serotypes).  Because such capsular polysaccharides may have low immunogenicity, it is desirable to enhance the effectiveness of vaccines comprising such polysaccharides by conjugating the polysaccharides to a carrier protein with high immunogenicity.  As the '999 patent explains, however, polysaccharide-protein conjugate vaccines aggregate when exposed to silicone oil, which is commonly used as a lubricant in vaccine storage containers.  The '999 patent describes a formulation that inhibits silicone-induced aggregation by suspending the polysaccharide-protein conjugate in a mixture of a pH-buffered saline solution and an aluminum salt.  Claim 1 of the '999 patent (the sole independent claim) recites:

1.  A formulation comprising (i) a pH buffered saline solution, wherein the buffer has a pKa of about 3.5 to about 7.5, (ii) an aluminum salt and (iii) one or more polysaccharide-protein conjugates, wherein the formulation is comprised in a siliconized container means and inhibits aggregation induced by the siliconized container means.

Claim 18 of the '999 patent recites:

18.  The formulation of claim 1, wherein the one or more polysaccharide-protein conjugate comprises an S. pneumoniae serotype 4 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 6B polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 9V polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 14 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 18C polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 19F polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 23F polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 1 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 3 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 5 polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 6A polysaccharide conjugated to a CRM197 polypeptide, an S. pneumoniae serotype 7F polysaccharide conjugated to a CRM197 polypeptide and an S. pneumoniae serotype 19A polysaccharide conjugated to a CRM197 polypeptide.

Thus, claim 18 is directed to a formulation comprising thirteen different S. pneumoniae serotype polysaccharides conjugated to a CRM197 polypeptide.

Merck Sharp & Dohme Corp. petitioned for inter partes review of claims 1–6, 10, 11, 14, and 17–20 of the '999 patent.  The Board instituted review of all challenged claims in two parallel proceedings:  IPR2017-00378, in which claim 1 was challenged as obvious in view of International Publication No. WO 03/009869 ("Chiron"); Smith, Siliconization of Parenteral Drug Packaging Components (1988) ("Smith"); and International Publication No. WO 2004/071439 ("Elan"), and IPR2017-00380, in which claim 1 was challenged as obvious in view of Chiron and Annex I of the European Medicines Agency's European Public Assessment Report for Prevenar ("Prevenar").  In each proceeding, Merck challenged claim 18 as obvious in view of the above references in combination with Peña et al., 24 Pediatrika 47 (2004) ("Peña"), which discloses a study involving a 13-valent conjugate, but does not disclose conjugating the polysaccharides with the CRM197 protein as recited in claim 18.  In both proceedings, the Board found all of the challenged claims except claim 18 to be unpatentable as obvious.

Merck appealed the Board's decisions as to claim 18, arguing that the Board failed to provide a reasoned basis for upholding claim 18.  As discussed in the Federal Circuit's opinion, "[t]he Board's decision rests on its finding that the study discussed in Peña did not show that 'a formulation comprising each of the thirteen known serotypes conjugated to a CRM197 [protein] . . . was even considered, tried and successful.'"  However, the Court notes that:

Standing alone, this finding is insufficient to support a lack of motivation or a reasonable expectation of success.  Obviousness, unlike anticipation, does not require a prior art successful formulation.  See Par Pharm., 773 F.3d at 1198.  Here, there was conflicting evidence as to motivation and reasonable expectation of success—evidence not discussed by the Board.

That conflicting evidence included the testimony of Merck's expert, who testified that a skilled artisan would have found it obvious to select the thirteen conjugates recited in Peña, each conjugated to CRM197, for a polysaccharide-protein conjugate vaccine, and Wyeth's expert, who testified that Peña would not have lead a skilled artisan to conclude that the 7-valent conjugate vaccine of Prevenar could be expanded to the 13-valent pneumococcal polysaccharide single-carrier CRM197 conjugate vaccine of claim 18 with a reasonable expectation of success.  According to the panel, the parties' differences concerned whether a skilled artisan would have been dissuaded from using a single carrier protein, such as CRM197, for a 13-valent pneumococcal polysaccharide conjugate vaccine due to "immune interference," a phenomenon that may result in decreased immunogenicity in multivalent vaccines with a sole carrier protein.

Although Merck argued that the immune interference issue is irrelevant, the Court disagreed, stating that "this issue is relevant to whether a skilled artisan would have been motivated to conjugate the 13 serotypes with CRM197 as a sole carrier protein."  In vacating and remanding the Board's decisions, the panel indicated that "the Board simply did not address the evidence as to whether someone skilled in the art would have been motivated to combine the 13 serotypes into a CRM197 conjugate or whether the potential loss of immunogenicity would have dissuaded someone skilled in the art from making such a combination," and concluded that "the Board’s decision is too cryptic to survive judicial review."  The Federal Circuit therefore vacated the Board's obviousness findings with respect to claim 18, and remanded for further consideration of the parties' arguments and evidence as to the motivation to combine, reasonable expectation of success, and other issues such as secondary considerations.

Merck Sharp & Dohme Corp. v. Wyeth LLC (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Dyk and Wallach
Opinion by Circuit Judge Dyk

CRISPR Housekeeping

By Kevin E. Noonan --

Part of every interference are a variety of housekeeping matters which, while not dispositive, are important to recognize for their effects (or potential effects) on the proceedings.  Some are simple matters:  for example, on October 28th, the Board granted the Broad's request for authorization to file a Reply to CVC's (the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier) opposition to the Broad's Substantive Motion No. 1 (which the Broad filed on November 4th), and CVC filed its revised protective order on November 7th, pursuant to the Board's earlier authorization.

More recently, the Board issued an Order denying CVC relief requested on two grounds.  First, CVC requested authorization to file a sur-reply to Broad's reply to CVC's opposition to Broad's Motion No. 1.  The Board denied this motion for now, saying that it could reconsider after it had had the opportunity to review the Broad's motion, CVC's Opposition, and the Broad's Reply.  This result logically followed from the grounds CVC asserted in support of its sur-reply request, including that the Broad in its reply had mischaracterized CVC's arguments in its Opposition.

The Board also denied CVC's request for a conference call to compel Broad to produce a witness for cross-examination.  The Order referred to the opportunity for CVC to file a Motion to Exclude Evidence at Time Period 5, which would dispose of the matter.  In noting this opportunity, the Board certainly sent a message to the Broad that the testimony of this witness could be put in jeopardy should it continue to resist.

Also on the issue of depositions, the Board on November 22nd issued an Order mediating a dispute between the parties on the amount of time each party will get for deposition.  The witnesses for each party are as follows:

Broad witnesses, relied upon for Motion Nos. 2, 3, and 4:

• Seeger        161 pg declaration (Exhibit 3401)
• Beaker        48 pg declaration (Ex. 3403)

CVC witness, relied upon for Motions 1 and 2:

• Peterson        first declaration 169 pg (Ex. 4036)
                        second declaration 153 pg (Ex. 4189)

The parties agreed that the Broad will make each witness available for seven hours of deposition, for a total of fourteen hours.  The Broad wanted twelve hours to depose CVC's witness and CVC objected, requesting the Board grant the Broad seven hours equal to the time each of the Broad's witnesses would sit for deposition.  The Board ordered that each party would have the same amount of time for deposition without regard to the number of witnesses.  The Board's reasoning was that the Broad was not responsible for CVC's choice to put forth one witness and, for seemingly practical reasons, the number of pages for CVC's lone declarant exceeded by about 100 pages the combined declarations of the Broad's two witnesses.

Finally, for now, on November 20th CVC provided an updated Notice of Related Proceedings, informing the Board and the Broad of the following newly granted patents (as well as additional pending applications), none of which are involved in this interference:

10,301,651 (USSN 14/685,504); 10,227,611 (USSN 14/042,782); 10,407,697 (USSN 15/435,233);  allowance of USSN 15/803,424; 10,385,360 (USSN 15/925,544); 10,421,980 (USSN 16/033,002); 10,415,061 (USSN 16/033,005); 10,308,961 (USSN 16/033,016); 10,358,658 (USSN 16/201,836); 10,337,029 (USSN 16/201,848); 10,351,878 (USSN 16/201,855); 10,400,253 (USSN 16/276,343); 10,428,352 (USSN 16/276,348); 10,443,076 (USSN 16/276,356); 10,487,341 (USSN 16/277,090); allowance of USSN 16/380,758;  allowance of USSN 16/380,781; AND allowance of USSN 16/382,093.

CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 4

By Kevin E. Noonan --

On October 14th, Senior Party the Broad Institute (joined by Harvard University and MIT) filed several authorized motions in Interference No. 106,115, including Substantive Motion No. 2 and No. 3, against Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC."  In its Motion No. 4, the Broad asks the U.S. Patent and Trademark Office Patent Trial and Appeal Board for priority to U.S. Provisional Application No. 61/736,527 to Zhang (termed "Zhang B1" in the motion), pursuant to 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) and Standing Order ¶ 208.4.1.

The brief begins by setting forth the standard for obtaining the relief requested:  "a party need only show a constructive reduction to practice—an enabled written description—of a single species within the count," citing Hunt v. Treppschuh, 523 F.2d 1386, 1389 (CCPA 1975); Weil v. Fritz, 572 F.2d 856, 865 n.16 (CCPA 1978); and Falkner v. Inglis, 448 F.3d 1357, 1362 (Fed. Cir. 2006).  For completeness, the brief sets forth the standard for constructive reduction to practice under 37 C.F.R. § 41.201.  According to the Broad, Zhang B1 "provides working examples and embodiments that meet each and every limitation of both halves of Count 1" and thus evinces to the skilled worker possession of an embodiment within the scope of the Count.

The brief includes a schematic of the relationship between Zhang B1 and the multiple patents and applications claiming priority thereto:

These priority relationships are claimed in each link in the priority chain, according to the Broad, with reference to more than a dozen facts set forth in the Appendix of material facts.  While admitting that the priority claim is set forth in each in "boilerplate language" (perhaps anticipating CVC's objection), the brief asserts that "[t]he PTAB has held that such 'boilerplate language' . . . broadly stating without further qualification that the earlier-filed patents are 'incorporated by reference,' is sufficient in view of Federal Circuit precedent to incorporate the disclosure of at least the [earlier filed] patent into each later-filed patent," citing Symantec Corp. v Finjan, Inc., 2016 WL 1081973 (IPR2015-01897 (PTAB February 26, 2016)) (citing Harari v Lee, 656 F. 3d 1331, 1335 (Fed. Cir. 2011).  Further support is asserted by the Broad because Example 1 from Zhang B1 is explicitly disclosed in Broad's involved U.S. Patent Nos. 8,771,945; 8,795,965; 8,871,445; 8,889,356; 8,932,814; 8,945,839; 8,906,616 and 9,840,713, as well as the Broad's involved U.S. Patent Application No. 14/704,551.  Other patents in the priority chain incorporate Zhang B1 by reference.  The brief then asserts that the priority claim in each case complied with the requirements of 35 U.S.C. § 120.

Turning to Example 1 of Zhang B1, the brief sets forth the argument for Zhang B1 satisfying the requirements for constructive reduction to practice, including the level of one of ordinary skill in the art and how Example 1 would be understood by such a person (in detail).  According to the Broad, "Zhang B1 sufficiently teaches, describes and enables each embodiment such that [a person having ordinary skill in the art would be able to use each embodiment successfully, without undue experimentation, and hence provides systems, cells, and methods falling within the scope of Count 1."  The brief characterizes as "the Broad half of the Count" the alternative recited in the Broad patent used as the exemplar of the Count and recites with reference to the specification the disclosure in Zhang B1 disclosing these elements.  The brief supports these explications of the Zhang B1 disclosure with expert affidavit testimony.  The brief then sets forth disclosure in Zhang B1 of the elements defined by the "CVC half of the Count," the alternative recited in the CVC application used as the exemplar of the Count.

The brief then turns to enablement, focused on the "working examples" of CRISPR-Cas9 set forth in Zhang B1, including disclosure of utility in eukaryotic cells for the disclosed technology.

Accordingly, the brief asks the Board to grant priority to Zhang B1, giving the Broad a presumptive priority date of December 12, 2012.

Conference & CLE Calendar

December 2, 2019 - "Cross-Border Trends, Tactics and Strategic Insights: What European and U.S. Lawyers Should Each Know About Litigating Abroad" (Practising Law Institute) - London

December 5, 2019 - Intellectual Property Law Educational Program (Clyde & Co and McDonnell Boehnen Hulbert & Berghoff LLP) - 6:15 pm to 7:00 pm, London

Clyde & Co and MBHB Intellectual Property Law Educational Program

Clyde & Co and McDonnell Boehnen Hulbert & Berghoff LLP will be hosting an onsite program from 6:15 pm to 7:00 pm on December 5, 2019 at Central Working (4th floor) in London (80 Wood Lane, White City, London W12 0BZ).  The program, which will take place in conjunction with I-HUB at Imperial College London, will offer presentations on the following topics:

• Patenting In the USA: Is There Anything Patent Eligible? -- Paul Tully and Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP
• Outstanding Benefit & Inventor Compensation -- Ralph Cox

A welcome reception will precede the program and a cocktail reception will follow the program.

There is no registration fee for the program.  However, those interested in attending the program must register by contacting Susan Hall at [email protected].  By registering for this event, attendees agree to Clyde & Co and MBHB processing their personal data for the purposes of facilitating the event.  Additional information about the event can be found here.

CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 3

By Kevin E. Noonan --

On October 14th, Senior Party the Broad Institute (joined by Harvard University and MIT) filed several authorized motions, including Substantive Motion No. 3 (to designate claims as not corresponding to the count), against Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC."  In its Motion No. 3, the Broad asks the Patent Trial and Appeal Board to designate some of its claims as not corresponding to the Count in Interference No. 106,115 as declared.

It should be appreciated that this Motion No. 3 is part and parcel of the Broad's motions to remake the contours of the interference, along with Motion No. 2 (to substitute the Count) and Motion No. 4 (to be awarded benefit of priority to USSN 61/736,527).  In this Motion No. 3, the Broad reiterates the arguments made in Motion No. 2, that there are two embodiments of CRISPR, one involving single-molecule RNA guide RNA (which the Broad argues here is not recited in the claims it wants the Board to designate as not corresponding to the Count) and further that certain of the Broad's claims directed to "SaCas9" systems that require two or more NLSs do not correspond to the Count.

The brief parsed the Broad's claims into three categories of claims that do not correspond to the Count, depending on how the Board rules on Substantive Motions Nos. 1 and 2:

• USP 8,865,406 – Claims 1-30 (all); 8,871,445 – Claims 1-30 (all); USP 8,889,356 – Claims 1-30 (all); USP 8,932,814 – Claims 1-30 (all); USP 8,945,839 – Claims 1-28 (all); USP 8,993,233 – Claims 1-43 (all); USP 8,999,641 – Claims 1-28 (all); USP 8,697,359 – Claims 1-3, 5-10, 12-17, and 19-20; USP 8,771,945 – Claims 1-4 and 6-29; USP 8,895,308 – Claims 1-9 and 11-28; USP 8,906,616 – Claims 1, 3-4, 6-30; USP 9,840,713 – Claims 1-7, 10-15, 17-26, and 28-41; and U.S. Patent Application No. 14/704,551: in the event that the Board denies both Motions No. 1 and 2

• USP 8,865,406 – Claims 1-30 (all) and USP 8,895,308 – Claims 1-30 (all): in any event, claims reciting Ca9 from Staphylococcus aureus

• USP 8,871,445 – Claims 1-30 (all); USP 8,932,814 – Claims 1-30 (all); USP 8,993,233 – Claim 7; USSN 14/704,551 – Claims 9-11: clams reciting two or mote nuclear localization signal

And what would remain, should the Board grant this motion:

• U.S. Patent No. 8,697,359, claims 4, 11, and 18; U.S. Patent No. 8,795,965, claims 1-30 (all); U.S. Patent No. 8,771,945, claim 5; U.S. Patent No. 8,906,616, claims 2 and 5; and U.S. Patent No. 9,840,713, claims 8-9, 16, and 27

Regarding the first set of claims the Broad asserts do not correspond to Count No. 1 (which the Broad admits "includes the vast majority of [its] Involved Claims"), the Broad argues that the Count of the interference as declared is directed to "single-molecule guide RNA molecule"-comprising embodiments and the claims it has asked the Board to designate as not corresponding to the Count do not encompass these embodiments.  The brief sets forth the Broad's understanding that, should the Board deny the Broad's Substantive Motions Nos. 1 and 2, then the interference will involve priority to such single-molecule guide RNA embodiments as a separate, patentable invention over claims that encompass both single-molecule and dual molecule embodiments.  Thus, the Broad argues that its claims limited to dual-molecule embodiments do not correspond to the Count and the Board should so designate.

The brief cites for support for its motion CVC's statements (erroneously termed "Remarks provoking this Interference"; the interference was declared sua sponte by the Board not provoked by CVC) that CVC's generic claims "should not be included in an interference involving [its single-guide RNA claims], because those other claims are generic with respect to the guide RNA and are thus directed to a separately patentable invention."  Under PTAB Rule 207(b), the Board provides relief to an inventor of a generic claim facing a specific count to move, as the Broad has done here, for their generic claims to be designated as not corresponding to the Count.  The Broad asserts as reasons/justifications for de-designating certain (most) of its claims:

• Count 1 is limited to the single-molecule invention, and would not be determining priority to generic, non-limited RNA embodiments of CRISPR, "violating" the "'primary purpose of an interference'" to make a priority determination of "each of the common [patentably distinct] inventions claimed by the parties,'" citing Godtfredsen v. Banner, 598 F. 2d 589, 592 (C.C.P.A. 1979).  The brief takes the opportunity to reiterate the unfairness of this outcome in view of the nature of their invention, e.g., a "breakthrough invention that revolutionized gene editing was the successful engineering of CRISPR-Cas9 systems for use in eukaryotic cells."

• There can be no interfering subject matter between the single-molecule RNA "invention" and generic, non-limited RNA CRISPR embodiments.  Under these circumstances, the brief argues a two-count interference should be declared with each invention to reiterate its allegation that CVC had made a strategic decision not to present claims to eukaryotic embodiments of CRISPR in the earlier, '048 interference.

• It would be unfair to put all the Broad's claims at risk under these circumstances because it would "t[ie] its hand to its best generic RNA proofs," which the brief characterizes as being "particularly egregious given that Broad could have relied on its best proofs during the 048 Interference, when the Count properly reflected the scope of the parties' claims."

Next, the Broad argues that its claims to SaCas9 embodiments and to claims requiring two or more nuclear localization sequences (NLS's) do not correspond to Count 1.  The Broad argues that these embodiments were not disclosed in the prior art and "provides a surprising combination of benefits not taught or suggested by the art" for both types of embodiments.

The brief then sets forth the Broad's characterization of the person of ordinary skill in the art, the properties and characterization of single- and dual-molecule RNA embodiments of CRISPR, a hagiography regarding the Broad's "pioneering eukaryotic CRISPR-Css9 work in 2011-2012" directed to dual-molecule RNA embodiments thereof, setting forth figures from contemporaneous grant proposals

and scientific papers, and the "Zhang B1" provisional USSN 61/736,527

illustrating its reduction to practice of these embodiments of the invention.

The brief then reiterates the history of the '048 Interference, the PTAB's decision, and the Federal Circuit's affirmance of there being no interference-in-fact between the claims in that interference.  Those claims were limited to eukaryotic cell embodiments for the Broad and unlimited with regard to target cell for CVC's claims; the brief notes that CVC provoked the claim to single-molecule CRISPR embodiments.  Following these events, CVC pursued claims to "generic/non-limited, single-molecule, and dual-molecule RNA" CRISPR embodiments.  This is followed by the Broad's continued inaccuracy in characterizing the interference as being "provoked" by CVC (in fact, the PTAB declared the interference sua sponte).  The brief accurately cites CVC's arguments to the PTAB that single-molecule RNA CRISPR was patentably distinct from dual-molecule RNA embodiments.

Section V of the brief sets forth its arguments based on these facts, that certain of its claims should not correspond to Count 1.  Citing 37 C.F.R. § 41.207 et seq., the brief asserts that the proper way to address the presumption regarding patentability must be addressed (as here) by filing a motion to designate claims as not corresponding to the count.  And:

In the situation with a two-count interference – with a generic count and a separate species count – such a motion would be often be deferred until the priority phase and dismissed "unless there were a split award on priority, in which case proof that the generic invention antedates the priority proofs for the lost species count would likely justify relief."

But here the PTAB has not declared a two-count interference, and according to the brief, the first interference satisfied the question of priority to the "generic" invention (and once again CVC should not be heard to complain about the consequences of their strategic choices in the Broad's view).

The brief argues that the PTAB's failure to grant the motion "would conflict with the primary purpose of interferences" (awarding priority to the first to invent a patentable invention, wherein defining that patentable invention is the question before the Board as set forth in the Broad's motions in this interference).  While the Count is directed to single-molecule RNA embodiments of CRISPR technology, the Broad's claims-in-interference encompass dual-molecule RNA embodiments as well (which the brief includes in its definition of the "generic, non-limited RNA invention").  The brief cites Godtfredsen (in which the court rejected a priority award to multiple species comprising a Markush group count in an instance where there were three patentably distinct inventions, because "the party who proved the earliest date of invention as to any one of the members of the group would be awarded priority as to the entire count") and Theeuwes v. Bogentoft, 2 U.S.P.Q.2d 1378 (B.P.A.I. 1986) (where there were two patentable inventions and the Board found it anomalous that party could be awarded priority a count covering species A and B while proving priority to species B alone) in support of its argument, and cites Ex Parte Hardman, 142 U.S.P.Q. (BNA) ¶ 329 (July 28, 1964), as an instance where the Board held a genus claim unpatentable over a species disclaimed in an earlier interference (finding it inequitable to find otherwise).  The brief ties this precedent to the claims in this interference it had moved to dedesignate, on the grounds that "Dr. Zhang succeeded with both dual and single molecule RNA systems" and "[t]hus, it would be entirely inappropriate to award priority to the broad invention of eukaryotic CRISPR systems to a party who made a species invention long after the break."  The remainder of the Broad's argument in this regard expound on the purported unfairness in determining priority to the claims it had moved to dedesignate based on Count 1.

The brief then supplements with greater specificity the distinctions between "generic, non-limited RNA" embodiments of CRISPR claimed in the claims the Broad moves to dedesignate and the single-molecule RNA embodiments encompassed in the Count, particularly with regard to definitions for "guide RNA," tracr RNA," and other species comprising various permutations of CRISPR technology, in contrast to CVC's interpretation of these terms in the claims.

Finally, the brief reiterates the Broad's arguments regarding claims reciting SaCas9 and species comprising more than 2 NLS's as not corresponding to the Count.  For the former species, the brief asserts that:

As of 2012, there were more than 600 bacterial Cas9 orthologs.  MF 29; Ex. 3226, Ran et al., In vivo genome editing using Staphylococcus aureus Cas9, 520 Nature 186-191 (2015), 1; Ex. 3401, Seeger ¶¶ 6.5, 6.13.  Broad is unaware of any prior art suggesting the use of, or providing reasons for the selection of, SaCas9 in a CRISPR system adapted for use in eukaryotes.  Indeed, CVC, in its Opposition to a similar motion in the 048 Interference, did not point to any such prior art either.  Ex. 3115, Paper 689 (Opp. to 048 Mot. 5).  Where, as here, the prior art choices are vast, the prior art must provide some reason to make the selection in order to find obviousness.  Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F. 3d 1358, 1364 (Fed. Cir. 2008).  Here, the prior art fails to provide, or even suggest, a reason to select SaCas9.

The brief similarly argues that the art did not suggest embodiments comprising more than two NLSs in CRISPR systems, and that its claims directed to such embodiments should be found not to correspond to the Count on that basis:

The prior art lacked disclosure of advantages for two or more NLS(s) demonstrates that the use of two or more NLSs and there is no teaching, suggestion, motivation or reason in the prior art that would have caused a POSA to use two or more NLSs.  . . .  Therefore, claims including a limitation requiring two or more NLSs should be designated as not corresponding to Count 1.

Koninklijke KPN N.V. v. Gemalto M2M GmbH (Fed. Cir. 2019)

By Michael Borella --

Koninklijke KPN N.V. (KPN) sued Gemalto M2M GmbH (Gemalto) and several other parties in the District of Delaware for infringement of its U.S. Patent No. 6,212,662.  The defendants moved for dismissal under Rule 12(c), contending that the asserted claims lacked subject matter eligibility.  The District Court judge granted the motion.  KPN appealed.

The Invention

The '662 patent involves checksums, which are calculations performed over blocks of data that result in a short (e.g., 16, 32, or 64 bit) code.  These calculations may be a simple exclusive or operation, a more complicated cyclic redundancy check, or a hash function.  Virtually all data transmitted on a network, wired or wireless, is accompanied by a checksum.  In most cases, the transmitter calculates the checksum, appends the code to the blocks of data to be sent, and then sends the block and code.  The receiver calculates its own version of the checksum over the blocks of data.  If this matches the transmitted code, then the receiver can be reasonably assured that the blocks of data were not corrupted (e.g., due to random noise) during the transmission.  But checksums are not perfect, and occasionally a corrupt block can produce the same code as if it were error free.

The inventors of the '662 patent observed that checksums often fail in the presence of certain types of systematic errors -- non-random errors that repeat from block to block.  For instance, "[i]f a fixed [checksum] generating function produced defective check data for a transmission that was corrupted with a given systematic error (e.g., first and fourth bit is erroneous in every data transmission), that fixed generating function would likely continue to produce the same defective check data every time that systematic error appeared."  In these cases, the systematic error will not be detected by the checksum.

The '662 patent involves "var[ying] the way check data is generated from time to time so that the same defective check data does not continue to be produced for the same type of persistent systematic error."  This variability dramatically decreases the probability that a receiver will not detect repetitive errors after validating the checksum.  One of the ways that the generation of check data can be varied is "through permutation, which interchanges the bit position in a data block."

The Claims

Of the claims invalidated, only 2, 3, and 4 were under appeal.  Claim 2 depends from claim 1, and claims 3 and 4 depend from 2, so all are shown below.

1.  A device for producing error checking based on original data provided in blocks with each block having plural bits in a particular ordered sequence, comprising:
    a generating device configured to generate check data; and
    a varying device configured to vary original data prior to supplying said original data to the generating device as varied data;
    wherein said varying device includes a per-mutating device configured to perform a permutation of bit position relative to said particular ordered sequence for at least some of the bits in each of said blocks making up said original data without reordering any blocks of original data.

2.  The device according to claim 1, wherein the varying device is further configured to modify the permutation in time.

3.  The device according to claim 2, wherein the varying is further configured to modify the per-mutation based on the original data.

4.  The device according to claim 3, wherein the permutating device includes a table in which subsequent permutations are stored.

The Patent-Eligibility Test

The two-part test from Alice Corp. v. CLS Bank Int'l is used to determine whether claims are eligible for patenting under 35 U.S.C. § 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 District Court Proceedings

The District Court found the claims to be directed to an abstract idea at step one of Alice because "they do not say how data is re-ordered, how to use reordered data, how to generate additional data, how to use additional data, or even that any data is transmitted," and for the dependent claims, "they do not say how the permutations are modified in time or modified based on the data."  The claims failed at step two of Alice, according to the District Court, because the "purported inventive concept was not captured in the claims."

The Federal Circuit Decision

On review, the Federal Circuit reversed the District Court.  Explaining the Alice framework, the Court wrote that "[i]n cases involving software innovations, [the step one] inquiry often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool."  The Court further noted that "[s]ince Alice, we have found software inventions to be patent-eligible where they have made non-abstract improvements to existing technological processes and computer technology."  Moreover, these improvements must be specific -- "[a]n improved result, without more stated in the claim, is not enough to confer eligibility to an otherwise abstract idea . . . [t]o be patent-eligible, the claims must recite a specific means or method that solves a problem in an existing technological process."

With respect to claims 2-4, the Court found them patent-eligible "because they are directed to a non-abstract improvement in an existing technological process . . . [b]y requiring that the permutation applied to original data be modified in time, claim 2 . . . recites a specific implementation of varying the way check data is generated that improves the ability of prior art error detection systems to detect systematic errors."  This results in "a new way of generating check data that enables the detection of persistent systematic errors in data transmissions that prior art systems were previously not equipped to detect."

The defendants argued that the claims were abstract because they "fail to recite a last application step that uses the generated check data to actually perform error detection," and thus lacked a concrete application.  The Court took a different view, stating that "[a] claim that is directed to improving the functionality of one tool (e.g., error checking device) that is part of an existing system (e.g., data transmission error detection system) does not necessarily need to recite how that tool is applied in the overall system (e.g., perform error detection) in order to constitute a technological improvement that is patent-eligible."  Further, "the more relevant inquiry is whether the claims in this patent focus on a specific means or method that improves the relevant technology or are instead directed to a result or effect that itself is the abstract idea and merely invoke processes and machinery."  Notably, the claimed modification of the permutation in time was a "specific solution for accomplishing [the] goal—i.e., by varying the way check data is generated by modifying the permutation applied to different data blocks."

The Court went on to distinguish the present claims over those found ineligible in Digitech Image Technologies, LLC v. Electronics for Imaging, Inc., RecogniCorp, LLC v. Nintendo Co., Two-Way Media Ltd. v. Comcast Cable Communications, LLC, and Intellectual Ventures I LLC v. Capital One Financial Corp.  The critical point for the Court was that "[w]hile the patents in these cases may have claimed an improved result in a technical field, the claims failed to recite a specific enough solution to make the asserted technological improvement concrete."  In contrast, claims 2-4 "specifically recite how this permutation is used (i.e., modifying the permutation applied to different data blocks), and this specific implementation is a key insight to enabling prior art error detection systems to catch previously undetectable systematic errors."

As a consequence, the claims are not abstract under step one of Alice, step two was not considered, and the Federal Circuit reversed the District Court.  The moral of this story is that a claim specifically reciting a particular technical improvement over the prior art, where the improvement is described as such in the specification, is better equipped to survive a § 101 challenge than a claim lacking either of these qualities.  Of course, the amount detail in the claimed technical improvement required to reach this level of specificity remains an open question.

Koninklijke KPN N.V. v. Gemalto M2M GmbH (Fed. Cir. 2019)
Panel: Circuit Judges Dyk, Chen, and Stoll
Opinion by Circuit Judge Chen

CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 2

By Kevin E. Noonan --

October 14th was a busy day at the Patent Trial and Appeal Board (PTAB) for the current interference over CRISPR technology (No. 106,115).  The Junior Party (the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC") filed its Substantive Motion No. 1 for priority benefit to its application No. 61/652,086, and its Opposition to the Senior Party's (the Broad Institute, Harvard University and MIT) Substantive Motion No. 1.  The Broad for its part filed three additional substantive motions (Contingent Motion No. 2 to substitute the count; No. 3 to designate claims as not corresponding to the count; and No. 4, for priority benefit to the Broad's application No. 61/736,528).  This post will discuss The Broad's Substantive Motion No. 2; future posts will review the remaining Broad motions and CVC's Substantive Motion No. 1.

This motion seeks to substitute the Count; Count 1 of the interference as declared is:

An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising a Cas9 protein and at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell, wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and the Cas9 protein cleaves the DNA molecules, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together, wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.

or

A eukaryotic cell comprising a target DNA molecule and an engineered and/or non-naturally occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-— CRISPR associated (Cas) (CRISPR-Cas) system comprising
    a) a Cas9 protein, or a nucleic acid comprising a nucleotide sequence encoding said Cas9 protein; and
    b) a single molecule DNA-targeting RNA, or a nucleic acid comprising a nucleotide sequence encoding said single molecule DNA-targeting RNA; wherein the single molecule DNA-targeting RNA comprises:
        i) a targeter-RNA that is capable of hybridizing with a target sequence in the target DNA molecule, and
        ii) an activator-RNA that is capable of hybridizing with the targeter-RNA to form a double-stranded RNA duplex of a protein- binding segment,
    wherein the activator-RNA and the targeter-RNA are covalently linked to one another with intervening nucleotides; and
    wherein the single molecule DNA-targeting RNA is capable of forming a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule, whereby said system is capable of cleaving or editing the target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule.

The Broad's proposed Count 2 is:

A method, in a eukaryotic cell, of cleaving or editing a target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule, the method comprising:
    contacting, in a eukaryotic cell, a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered Regularly lnterspaced Short Palindromic Repeats (CRISPR)-CRISPR associated Cas) (CRISPR-Cas) system comprising:
        a) a Cas9 protein, and
        b) RNA comprising
            i) a targeter-RNA that is capable of hybridizing with the target sequence of the DNA molecule or a first RNA comprising (A) a first sequence capable of hybridizing with the target sequence of the DNA molecule and (B) a second sequence; and
            ii) an activator-RNA that is capable of hybridizing to the targeter-RNA to form an RNA duplex in the eukaryotic cell or a second RNA comprising a tracr sequence that is capable of hybridizing to the second sequence to form an RNA duplex in the eukaryotic cell,
    wherein, in the eukaryotic cell, the targeter-RNA or the first sequence directs the Cas9 protein to the target sequence and the DNA molecule is cleaved or edited or at least one product of the DNA molecule is altered.

The distinction the Broad makes is between embodiments of CRISPR methods that are limited to "single-molecule guide RNA" (aka "fused" or "covalently linked" species), versus embodiments that encompass single-molecule and "dual molecule" species (wherein the in the latter versions the "targeter-RNA" and "activator-RNA" as recited in the proposed Count are not covalently linked).  The Broad argues that this Count should be adopted by the Board because it "properly describes the full scope of the interfering subject matter between the parties because both parties have involved claims that are generic, non-limited RNA claims."  The brief also argues that proposed Count 2 "sets the correct scope of admissible proofs [i.e., their own] for the breakthrough invention described by the generic claims at issue in these proceedings—the successful adaption of CRISPR-Cas9 systems for use in eukaryotic environments," which The Broad contends current Court 1 (in either alternative) does not.

The brief also requests that the Broad be accorded benefit to its provisional application U.S. Serial No. 61/736,527, and that CVC not be accorded benefit to any of its earlier applications (which just maintains the status quo requiring CVC to move to be accorded benefit), because CVC's applications-in-interference were not accorded benefit when this interference was declared.

The Broad's argument in support of its motion is that Count 1 is too narrow for encompassing just a subset of the parties' involved claims.  In particular, the brief asserts that most of the Broad's involved clams encompass "non-limited" RNA systems and methods.  Similarly, the brief argues that CVC itself has many claims directed to non-limited RNA systems and methods and has entire applications that do not recite claims to non-limited RNA systems and methods.  The Broad asserts that Count 1 does not permit the Broad to rely on its earliest and best proofs of invention, which the brief states is "plainly unfair."  This unfairness would preclude the Broad from establishing what the brief terms "the fundamental breakthrough - the invention of use of CRISPR in eukaryotic cells" (emphasis in brief).  Failing to substitute the Count would instead improperly focus the priority question on who invented the single molecule modification.  Colorfully, the brief declares that "[a]llowing the interference to proceed with Count 1 would permit the (single molecule RNA) tail to wag the (breakthrough use of CRISPR in eukaryotic cells) dog."

The claims include such generic species that encompass both single-molecule and dual molecule embodiments, according to the brief, but the breakthrough invention was adapting CRISPR-Cas9 to be used in eukaryotic cells, an argument the Broad has used consistently here and in the earlier '048 interference to distinguish its claims from CVC's.  The brief notes that the first disclosure of this use was in a scientific journal article by some of the Broad's named inventors that "has become by far the most frequently cited CRISPR publication" as evidence of the groundbreaking nature of the invention.  Also cited (as a reminder to the Board of its earlier decision, the basis thereof and the Federal Circuit's affirmance of it) is the Board's earlier decision that there was no reasonable expectation of adapting CRISPR for use in eukaryotic cells as further evidence of the breakthrough nature of (as asserted herein) the Broad's invention.

It is then the Broad's turn to allege that its opponent is attempting to avoid this interference, "on fair terms," the question of which party invented use CRISPR in eukaryotic cells.  The Broad sets out its allegations against CVC, first for "tr[ying] to engineer" the '48 interference on "environment-free" proofs, and now for "trying to engineer a single-molecule RNA eukaryotic CRISPR interference" that would prevent the Broad from relying on its best (i.e., early dual molecule RNA) proofs.  Whereas, according to the Broad, CVC is attempting to rely on reduction to practice of single-molecule RNA systems that "occur[ed] over a year after Broad's alleged earliest reductions to practice" (emphasis in brief).  The consequence of using Count 1 would raise "'the anomalous possibility' that CVC could win priority as to the full scope of the commonly claimed invention (and Broad could lose all of its designated claims, including non-limited RNA claims) merely by CVC proving priority based on a later reduction to practice on a limited count, even though Broad made the broad invention of the designated claims first."

Further, echoing arguments made in its Substantive Motion No. 1, using such an "artificially narrow count" would permit CVC to avoid the estoppel effects of the decision in the '048 interference, according to the Broad.  The brief cites a CVC press release touting the risk this interference provokes that "jeopardizes all of the Broad's CRISPR patents as (somehow) being evidence that CVC is unfairly trying to obtain an undeserved windfall in its interference strategy (ignoring the fact that it was the PTO that declared the interference and determined the Count).

The Broad then provides the Board with, in the alternative, either proceeding with this interference under Count 1 but finding that non-limited RNA claims do not correspond to the Count, or proceeding with a two Count interference, with one Count directed to using CRISPR in eukaryotic cells and the other directed to single-molecule RNA species.

The brief then sets forth the differences between non-limited and single-molecule RNA versions of CRISPR, and its history of the development of its eukaryotic cell embodiments of CRISPR technology, making distinction between single-molecule RNA and dual molecule RNA embodiments, and liberally illustrating the brief with diagrams from its own NIH grant applications and scientific references.  The brief then synopsizes the decision in the earlier '048 interference based on there being no reasonable expectation of success in achieving eukaryotic cell applications of CRISPR based on earlier applications of CRISPR in prokaryotic cells.  This was followed by the Broad's description of the CVC's further prosecution of the applications in this interference.

Section V of the brief adopts the format of motions in interference practice of setting forth the basis for the PTAB to grant the motion.  For motions such as this one, the standard is that the current Count does not encompass the full scope of the interfering subject matter and excludes the Broad's best proofs.  See, Grose v. Plank, 15 U.S.P.Q.2d 1338, *4-6 (B.P.A.I. 1990); Kondo v. Martel, 220 U.S.P.Q. 49, *2-3 (B.P.A.I. 1983); Nelson v. Drabek, 212 U.S.P.Q. 98 *2-3 (Comm'r 1979).  The interfering subject matter, according to the Broad, is claims to non-limited RNA (i.e., single molecule and double molecule species of RNA) for use in eukaryotic cells; the grounds for this allegation is that each party has involved claims to this subject matter.  The crux of this argument (echoed throughout) is that "the Count should be set to resolve the parties' dispute as to who made the breakthrough necessary to make CRISPR Cas9 systems and methods work in a eukaryotic environment first, not just which party first disclosed 'fused' or 'covalently-linked' guide RNA," citing In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).  Doing otherwise (i.e., maintaining Count 1) would result (according to the Broad) in the Board awarding priority "not to the party that invented [use of CRISPR in eukaryotic cells] first, but rather to whomever can show they made the single molecule modification to that invention first."

The Broad contends that Count 1 puts all their claims at risk (a complaint contrary to arguments that the Board should settle the interference (in their favor) once an for all.  And the brief reiterates the allegation that this is fundamentally unfair because CVC made a "its deliberate decision to not include eukaryotic CRISPR claims in the 048 Interference, in which Broad could have used proofs commensurate in scope with the scope of its claims."

Next the Broad sets forth its arguments why the PTAB should grant the motion and substitute this Count 2.  First, according to the brief, Count 2 is consistent with the scope of the parties' claims and properly describe the scope of the interfering subject matter.  Because the Broad has proofs relating to using dual molecule RNA in CRISPR prior to CVC's claims-in-interference, and limiting their proofs to single molecule embodiments (which cannot antedate CVC's claims in interference) would limit the extent to which the Broad could counter CVC's priority proofs.  And as they have argued elsewhere, CVC's own public statements are used to imply that Berkeley and its colleagues are pursuing the broader scope because it puts essentially all the Broad's patents at risk (ignoring for the purpose of its argument that CVC did not provoke this interference or suggestion this Count No. 1, both of which are sua sponte creatures of the PTAB itself).

With regard to its "best proofs" argument, the Broad cites caselaw (Univ. of S. California v. DePuy Spine, Inc., 473 F. App'x 893, 23 895 (Fed. Cir. 2012)) the Board's regulations (37 C.F.R. § 41.121, § 41.201, and § 41.208(a)(2)); and the MPEP (MPEP § 2304.02(b)) in support of its position.  The brief supplements these citations with what CVC is "likely" to argue, i.e., "that Broad is barred from relying on some of its best proofs supporting priority as to its non-limited claims, which are the vast majority of its involved claims."  Those "best proofs" are duel-molecule guide RNA embodiments used in eukaryotic cells that the Broad contends are entitled to a filing date in 2012 earlier than any possible CVC priority date, based inter alia on affidavit testimony submitted with its brief in addition to declarations and laboratory evidence submitted during ex parte prosecution.  And of course the Broad reminds the Board that the consequence could be awarding priority to a later inventor, contrary to the purpose of interferences.

In the alternative, the Broad argues that should the PTAB determine that the estoppel the Broad argued in Substantive Morton No. 1 does not apply, and that the interference will proceed under Count 1, the PTAB should designate the Broad's claims directed to dual-molecule RNA embodiments as not corresponding to Count 1, or sua sponte declare a two Count interference.

The brief next turns to the benefit of priority to which they are entitled under Count 2, specifically the Zhang B1 reference and any intervening patents or applications claiming priority to USSN 61/736,527 (Zhang B1), illustrated by this diagram and supported by evidence set forth in Appendix 3:

The brief then sets forth, in detail, element-by-element, support in Zhang B1 for the recited elements of the Count.  Also recited is the asserted basis for priority in each of the related, later-filed applications set forth in the diagram, as well as the '945, '965, '445, '356, '814, '839, '616 and '713 Patents and '551 application, thus reaffirming that these patents-in-interference were entitled to the priority claim.

In contrast, the Broad argues that CVC is not entitled to any priority, based in part because there was no benefit of priority was accorded by the Board when this interference was declared.

Section V.F. then argues that Count No. 2 recites subject matter that is patentable over the prior art, when considered in light of the Broad being entitled to the December 12, 2012 filing date of the Zhang B1 reference, first by analogy to the subject matter of the Count in the '048 Interference (and, extensively, the PTAB's decision in that interference and the Federal Circuit' affirmance thereof) and also because the Broad's claims corresponding to Count No. 2 had been allowed over the prior art of record.

Finally, the Broad's brief argues which of its claims correspond to Count No. 2:

USP 8,697,359 – Claims 1-20 (all); USP 8,771,945 – Claims 1-29 (all); USP 8,795,965 – Claims 1-30 (all); USP 8,889,356 – Claims 1-30 (all); USP 8,906,616 – Claims 1-30 (all); USP 8,945,839 – Claims 1-28 (all); USP 8,993,233 – Claims 1-6 and 8-43; USP 8,999,641 – Claims 1-28 (all); USP 9,840,713 – Claims 1-41 (all); and UPS 14/704,551 – Claims 2, 4-8, and 12-18

And which do not (and arguments in support of its designations).  The brief also sets out which of CVC's claims so correspond (all of them).

USPTO Subject Matter Eligibility October Update: Example 46

By Michael Borella --

Last month the U.S. Patent and Trademark Office published an update ("October Update") to its subject matter eligibility guidance.  As we noted at that time, the October Update is more evolutionary than revolutionary, and primarily serves to provide clarifications to the more substantive January Guidance.  Nonetheless, the USPTO did provide four additional examples applying its revised test for subject matter eligibility under 35 U.S.C. § 101 to hypothetical claims.  Here, we discuss Example 46.

The background, of course, 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.  These parts are denoted by the USPTO as steps 2A and 2B, respectively (step 1 is to determine whether the claimed invention is one of the four statutory categories of subject matter set forth in § 101, and is rarely at issue in practice).

Under step 2A, one must decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then under step 2B one further decides 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.  Elements or combinations thereof 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 January Guidance breaks the first part of the Alice test into two sub-steps (let's call them 2A(i) and 2A(ii) for purposes of clarity).  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 January Guidance indicates that, under step 2A(i), 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.

If the analysis moves on to sub-step 2A(ii), then one determines "whether the claim as a whole integrates the recited judicial exception into a practical application of the exception."  Such a claim "will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception."

Example 46 applies this test to four claims directed to an invention for obtaining and analyzing identification and behavioral data of livestock animals, such as dairy cattle.  In some of these claims, cattle with aberrant behavior are identified, while in others cattle so identified are separated from the herd by a gating system or treated with a modified diet intended to address the disease of which the aberrant behavior is a symptom.

Claim 1

Claim 1 recites:

A system for monitoring health and activity in dairy livestock animals comprising:
    a memory;
    a display; and
    a processor coupled to the memory programmed with executable instructions, the instructions including
        a livestock interface for obtaining animal-specific information, wherein the animal-specific information comprises animal identification data and at least one of body position data, body temperature data, feeding behavior data, and movement pattern data; and
        a monitoring component for
            (a) comparing the obtained animal-specific information with animal information from a herd database to verify an animal's identity, and
            (b) analyzing the obtained animal-specific information to identify whether the animal is exhibiting an aberrant behavioral pattern as compared to past behavior of the animal, and
            (c) displaying the analysis results for the animal on the display.

The USPTO begins its substantive analysis by applying step 2A(i).  Under the October Update, a claim recites a judicial exception when such an exception is explicitly set forth or implicitly described in the claim.  Based on this interpretation, the USPTO finds that limitations (a) and (b) are an observation and an evaluation, respectively.  Thus, they are "acts that can be practically performed in the human mind," and fall within the mental processes category of abstract ideas.  Further, "[t]he recitation of a processor in this claim does not negate the mental nature of these limitations because the claim here merely uses the processor as a tool to perform the otherwise mental processes."

Moving on to step 2A(ii), the USPTO identifies the additional elements as "the memory, the display, the processor, the livestock interface, and limitation (c)."  The first three of these elements are rapidly dismissed as being non-substantive for purposes of the § 101 analysis, because "they represent no more than mere instructions to apply the judicial exception on a computer [and] nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer."  Additionally, the USPTO finds that the livestock interface is just "insignificant extra-solution activity" because it is used for data gathering and is recited at a high level of generality.  Limitation (c), on the other hand, only "performs the necessary software tasks so that the result of the abstract mental process is displayed."  Thus, the additional elements, when considered in isolation, do not integrate the abstract idea into a practical application.

The step 2A(ii) analysis also requires considering the additional elements in combination with one another and the rest of the claim.  The USPTO states that the claim as a whole does no more than "automate the mental processes that the farmer used to perform (e.g., the mental inspection and evaluation of the livestock animals' behavior), using the computer components as a tool."  Notably, "[w]hile this type of automation improves the daily life of farmers (by minimizing or eliminating the need for mentally evaluating the behavior of livestock animals), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology."  Therefore, the claim fails to integrate the abstract idea.

Step 2B proceeds similarly as that of step 2A(ii).  The memory, display, and processor are "at best the equivalent of merely adding the words "apply it" to the judicial exception."  The livestock interface and limitation (c) are still extra-solution activity.  The USPTO then states, in a rather conclusory fashion, "[e]ven when considered in combination, these additional elements represent mere instructions to apply an exception and insignificant extra-solution activity, which cannot provide an inventive concept."

As a consequence, claim 1 is ineligible.

Claim 2

Claim 2 depends from claim 1, and recites:

The system of claim 1, wherein the system further comprises
    a feed dispenser that is connected to a feed and supplement supply and is operable to dispense individualized amounts of feed and optional supplements, and
    wherein the monitoring component is further configured for
        (d) automatically sending a control signal to the feed dispenser to dispense a therapeutically effective amount of supplemental salt and minerals mixed with feed when the analysis results for the animal indicate that the animal is exhibiting an aberrant behavioral pattern indicative of grass tetany.

Since claim 2 incorporates all elements of claim 1 and two of those incorporated elements have already been found to recite an abstract idea, claim 2 also recites an abstract idea under step 2A(i).

Regarding step 2A(ii), the USPTO writes that "limitation (d) does not merely link the judicial exceptions to a technical field, but instead adds a meaningful limitation in that it can employ the information provided by the judicial exception . . . to operate the feed dispenser."  Moreover, "[l]imitation (d) in combination with the feed dispenser enables the control of appropriate farm equipment based on the automatic detection of grass tetany, which goes beyond merely automating the abstract idea."

The main difference between ineligible claim 1 and eligible claim 2 is the addition of feed dispenser and how it is triggered to the latter.  This adds a non-computer physical element to the claim which changes state in response to the "mental" calculations performed by the computer.  This appears to be enough to transform the claimed invention into one that meets the requirements of § 101.

Another way of differentiating between claims 1 and 2 is to make an analogy to Supreme Court and Federal Circuit case law regarding the law of nature and natural phenomena exceptions.  Particular, since Mayo v. Prometheus and its progeny, diagnostic method claims are almost certainly going to be found ineligible, whereas method of treatment claims can be eligible.  Claim 1 reads like a diagnostic method claim (e.g., gathering patient data and determining whether there is presence or likelihood of a disease), while claim 2 reads like a method of treatment claim (e.g., administering a medicine or nutritional supplement to a patient who has been diagnosed with a disease).  In that light, the USPTO is at least being consistent with the precedent, even if the correctness of that precedent has been called into question.

Claim 3

Claim 3 focuses on separating cattle identified as possibly suffering from an illness from those that do not.  It recites (edited to fix apparent typographical errors in the enumeration of steps):

A method for monitoring health and activity in dairy livestock animals comprising:
    (a) causing a herd of livestock animals to enter a sorting gate that is automatically operable, wherein each animal in the herd is equipped with an animal sensor having a radio frequency transponder,
    (b) for a particular animal in the herd, obtaining, by a radio frequency reader mounted on or near the sorting gate, animal-specific information from the animal sensor when the animal sensor is within proximity to the radio frequency reader, the animal-specific information comprising animal identification data and at least one of body position data, body temperature data, feeding behavior data, and movement pattern data,
    (c) analyzing, by a processor, the obtained animal-specific information from step (b) with respect to animal information stored in a herd database to identify the animal and to determine whether the animal is exhibiting an aberrant behavioral pattern as compared to the past behavior of the animal,
    (d) automatically operating the sorting gate, by the processor sending a control signal to the sorting gate to route the animal into a holding pen when the analysis results from step (c) for the animal indicate that the animal is exhibiting an aberrant behavioral pattern, and by the processor sending a control signal to the sorting gate to permit the animal to freely pass through the sorting gate when the analysis results for the animal indicate that the animal is not exhibiting an aberrant behavioral pattern, and
    (e) repeating steps (b) through (d) for each animal in the herd.

Analyzing the claim, the USPTO observes that step (a) "does not impose any limits on how the livestock animals are caused to enter the sorting gate" while steps (b) and (c) "[do] not impose any limits on how the radio frequency reader obtains the animal-specific information, or on how the analysis of the information is accomplished."  Similarly, step (d) "does not impose any limits on how the sorting gate is operated."  The USPTO also notes that the conditional dependencies between the steps results in three embodiments being covered under broadest reasonable interpretation:

[A] first embodiment in which only the first condition and first action occur (all animals exhibit aberrant behavioral patterns and are thus routed to the holding pen); a second embodiment in which only the second condition and second action occur (all animals exhibit normal behavioral patterns and are thus permitted to freely pass through the sorting gate); and a third embodiment in which both conditions and both actions occur (some animals exhibit aberrant behavioral patterns and are thus routed to the holding pen, and other animals exhibit normal behavioral patterns and are thus permitted to freely pass through the sorting gate).

Applying step 2A(i), the USPTO finds that step (c) of the claim recites the abstract idea of performing an evaluation.  This evaluation of "whether the animal is exhibiting an aberrant behavioral pattern as compared to the past behavior of the animal" could practically be performed in the human mind by observing the animal.

Turning to step 2A(ii), the USPTO quickly dismisses steps (a) and (e) of the claim as "nothing more than an attempt to generally link the use of the judicial exception to the particular field of livestock management," while step (b) "represents mere data gathering."  The USPTO also takes issue that "steps (b) and (c) are also recited at a high level of generality and represent no more than mere instructions to apply the judicial exception using generic computer components."

On the other hand, the USPTO's view of step (d) of the claim is that, under all three embodiments, it "does not merely link the judicial exception to a technical field, but instead adds a meaningful limitation in that it employs the information provided by the judicial exception . . . to operate the gate control mechanism and route the animals."  As a result, "step (d) goes beyond merely automating the abstract ideas and instead actually uses the information obtained via the judicial exception to take corrective action by operating the gate and routing the animals in a particular way."  This is an integration of "the judicial exception into the overall livestock management scheme and accordingly practically applies the exception, such that the claim is not directed to the judicial exception."

Therefore, claim 3 is eligible.

Claim 4

Claim 4 uses similar language as that of claim 1, but takes the invention in a different direction.  It recites:

A system for monitoring health and activity in a herd of dairy livestock animals comprising:
    a memory;
    a processor coupled to the memory programmed with executable instructions, the instructions including a livestock interface for obtaining animal-specific information for a plurality of animals in the herd, wherein the animal-specific information comprises animal identification data and at least one of body position data, body temperature data, feeding behavior data, and movement pattern data; and
    a herd monitor including (a) a radio frequency reader for collecting the animal-specific information from a plurality of animal sensors attached to the animals in the herd when the animal sensors are within proximity to the radio frequency reader, each animal sensor having a radio frequency transponder, and (b) a transmitter for transmitting the collected animal-specific information to the livestock interface.

Notably, the difference between claims 1 and 4 is that the former comprises the aforementioned comparing, analyzing and displaying steps that were found to be abstract, while the latter includes the herd monitor with its radio frequency reader and transmitter.

Under step 2A(i), the USPTO rapidly concludes that there is no judicial exception recited in the claim.  Particularly, "[t]he claim does not recite any abstract ideas, such as a mathematical concept, mental process, or a method of organizing human activity such as a fundamental economic concept or managing interactions between people."  Further, "[t]he system's operation, like all computers, is based on mathematical theory, but that underlying operation does not trigger an eligibility analysis because it is not set forth or described in the claim."  Therefore, the claim is eligible.

Analysis

We have found the USPTO eligibility examples helpful from time to time.  But some, like this one, raise new questions as it provides a few answers.  First, as noted above in the discussions of claims 1 and 2, is the USPTO taking the position that improvements using generic physical components that save people time are less likely to be eligible than improvements to specific devices that have the same outcome?  If so, that requires an evaluation of whether a claimed invention improves a person's performance or a machine's performance, which is difficult in practice with many software-based inventions.  For example, a new algorithm that recommends a course of action for a human to take might result in both human and computer performance being enhanced.

Second, the differences in the eligibility outcome of claims 1 and 4 require some rather thin bacon slicing, and involve nuances that many examiners, PTAB judges, and attorneys might not appreciate as relevant.  Further, what if we added the comparing, analyzing and displaying steps from claim 1 into claim 4?  Under the October Update, claim 4 would now recite an abstract idea, but would the herd monitor result in an integration into a practical application?  In a broader sense, can adding limitations to an eligible claim render it ineligible?  As the slogan for an infamous tabloid publication goes, inquiring minds want to know.

Conference & CLE Calendar

November 21, 2019 - "Alphabet Soup: A Review and Summary of Post-Grant Practice at the USPTO" (Fitch Even) - 12:00 to 1:00 pm (EST)

December 2, 2019 - "Cross-Border Trends, Tactics and Strategic Insights: What European and U.S. Lawyers Should Each Know About Litigating Abroad" (Practising Law Institute) - London

Webinar on Post-Grant Practice

Fitch Even will be offering a webinar entitled "Alphabet Soup: A Review and Summary of Post-Grant Practice at the USPTO" on November 21, 2019 from 12:00 to 1:00 pm (EST).  David A. Gosse of Fitch Even will provide a summary of post-grant procedures and an introduction to when, why, and how each procedure is useful (or not) to patent owners and third parties, and will also discuss the following:

• Review of post-grant procedures at the USPTO including inter partes review (IPR), post-grant review (PGR), covered business method review (CBM), supplemental examination, ex parte reexamination, and reissue applications
• Strategic purposes of the various post-grant procedures
• Tactics for petitioners and patent owners in USPTO trial proceedings

While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.

PLI Program on Litigating Abroad

Practising Law Institute (PLI) will be offering a program entitled "Cross-Border Trends, Tactics and Strategic Insights: What European and U.S. Lawyers Should Each Know About Litigating Abroad" on December 2, 2019 in London.  The half-day program, which will be webcast, will cover specialized issues that impact litigators in Europe and the U.S., and explore timely international litigation issues.  The program will allow attendees to:

• Master cross-border tactics and litigation strategies
• Compare European group claims and U.S. class action cases
• Describe Brexit's impact on cross-border disputes between the U.S. and UK

The registration fee for the program or webcast is $895.  Those interested in registering, can do so here.