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  • FCBA Remote Program on PTAB

    Federal Circuit Bar Association_2The Federal Circuit Bar Association (FCBA) PTAB/TTAB Committee will be offering a remote program entitled "PTAB Review: Effects of Arthrex and Potential Future Reforms" on December 3, 2021 from 12:00 pm to 1:00 pm (ET).  Robert Bauer of Bauer Law Offices will moderate a panel consisting of Lora Green of Wilson Sonsini Goodrich & Rosati (former Administrative Patent Judge, U.S. Patent and Trademark Office); James Toupin, Adjunct Professor, American University, Washington College of Law (former General Counsel, U.S. Patent and Trademark Office); John Wheelan, Associate Dean for Intellectual Property Law, George Washington University Law School (former Deputy General Counsel for IP Law and Solicitor, U.S. Patent and Trademark Office); and Molly Silfen, Counsel Detailee, United States Senate (on detail from Office of the Solicitor, U.S. Patent and Trademark Office).  The webinar will address recent and prospective developments in PTAB proceedings, including practice alter the recent Supreme Court decision in Arthrex, and focus on new legislative developments and other reform proposals relating to the management and administration of PTAB proceedings.

    The webinar is complimentary for FCBA and students, $50 for government/academic/retired non-members, and $175 for private practitioner non-members.  Those interested in registering for the program, can do so here.

  • CVC Files Motion to Exclude Evidence, ToolGen Opposes, and CVC Replies in Interference No. 106,126

    By Kevin E. Noonan —

    University of California-BerkleyOn September 17th, Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") filed its Motion to Exclude certain evidence presented by Senior Party ToolGen Inc. in Interference No. 106,126.  ToolGen filed its Opposition to CVC's motion on October 8th, and CVC filed its Reply on October 15th.

    CVC objected to but two ToolGen exhibits, as set forth in this Table:

    Table
    In its brief, CVC noted that it had preserved its objections under 37 C.F.R. § 41.155(b)(1) by timely filing 7 days after ToolGen served these exhibits.  On the merits, CVC supported its objection to Ex. 1283 being that the YouTube video of Dr. Dana Carroll was "juxtaposed with untitled graphics and drawings in a different window."  ToolGen, CVC asserted, failed to authenticate the video, i.e., provided no substantiating testimony through a witness subject to cross-examination.  Nor, according to CVC, did ToolGen provide any "evidence regarding who posted this video and when, whether it was edited, and whether it accurately portrays Dr. Carroll's opinions or understandings, especially with respect to the purposes for which ToolGen cites it."  And nor, argued CVC, did ToolGen provide any "explanation as to who extracted the video from the internet and provides no metadata to establish its origins" and ToolGen did not question Dr. Carroll about the video during his deposition.

    CVC's basis for its objection to Ex. 1593 was that ToolGen provided the interview "for the truth of the matter asserted," i.e., "CVC inventors' timing, difficulty, challenges, and knowledge relating to their invention of CRISPR-Cas9 in eukaryotes."  This constitutes "double hearsay" according to CVC and should be inadmissible because "it is a third-party's out of court statement recounting a party's out of court statement."  Moreover, CVC argued that "[t]he cited publication is an edited excerpt of a longer interview, as evidenced by bracketed text within Dr. Doudna's responses and other expository remarks."  These revisions were not made to "present a historical account of facts for the purposes of resolving intellectual property rights" CVC asserts but rather "were formulated to 'capture the interest' of the intended audience."  That these are the inventor's out-of-court statements does not rescue them from a hearsay objection according to CVC, citing Horta v. Sullivan, 4 F.3d 2, 8 (1st Cir. 1993) and New England Mut. Life Ins. Co. v. Anderson, 888 F.2d 646, 650 (10th Cir. 1989).  Neither does their status as "hearsay within hearsay" make them admissible under the party admission against interest under Fed. R. Evid. 805 according to CVC because "[o]ut-of-court statements that have been curated by a third-party for other purposes are not admissible to prove the sequences of events, the motivations, intentions, and expectations of the inventors," citing SO ¶ 152.2.1.

    In its Opposition filed October 8th, ToolGen began its argument my reminding the Board that these are CVC's fact witnesses who are contradicting current positions taken in the interference.  As for the YouTube video (Ex. 1283), ToolGen asserts that CVC objected to only 15 seconds of a 53-minute video, but that in these 15 seconds "Dr. Carroll admits that ToolGen inventor Dr. Jin-Soo Kim discovered what was not obvious to skilled artisans at the time—that adding two guanines to the 5' end of guide RNA improves its specificity."  With regard to CVC's authenticity arguments, ToolGen noted that "the video shows that it was posted by the Innovative Genomics Institute, a company founded by CVC's own Dr. Doudna" (stating later in the Opposition that "CVC is thus challenging the authenticity of a video of its own witness, posted by its inventor's organization").  ToolGen argued further that there were "multiple indicia of authenticity supporting that the video reliably depicts Dr. Carroll and his views."  ToolGen contends that under FRE 901(b)(4), "the appearance, contents, and distinctive characteristics of the video support a finding that the video is what ToolGen claims it is: a lecture by Dr. Dana Carroll," citing Zen Design Grp., Ltd. v. Scholastic, Inc., No. 16-12936, 2019 WL 2996190, at *2 (E.D. Mich. July 9, 2019).  According to ToolGen, "[t]he Innovative Genomics Institute, Dr. Doudna, and Dr. Carroll also have had years to remove this video from YouTube if there were any inaccuracies depicted.  They have not done so."  ToolGen draws the conclusion that:

    CVC moves to exclude this evidence only because the video clip directly contradicts CVC's litigation position with respect to obviousness.  Given the totality of the circumstances, the video is authentic and accurately depicts Dr. Carroll admitting that ToolGen was the first to discover that two guanines on the 5' end of the guide RNA improves specificity.

    Regarding the Doudna interview, ToolGen argued that even CVC's own exhibits contained articles where Dr. Doudna expresses the same sentiments regarding adapting CRISPR to eukaryotic cells, citing "Ex. 2279 ("We weren't sure if CRISPR/Cas9 would work in eukaryotes[.]"); Ex. 2032 ("Doudna experienced 'many frustrations' getting CRISPR to work in human cells."); Ex. 2033 ("[I]t was not known whether [a CRISPR-Cas9] system would function in eukaryotic cells.")."  These are "multiple indicia of trustworthiness" ToolGen contended; moreover, ToolGen argued that "Dr. Doudna's contemporaneous thoughts are far more probative than Dr. Doudna's testimony prepared for (sic) litigation."  ToolGen contended that Dr. Doudna's own statements were not hearsay under FRE 801(d)(2) because she is a party opponent, citing Nuance Communs., Inc. v. Abbyy Software House, 626 F.3d 1222, 1230 n.1 (Fed. Cir. 2010).  ToolGen also asserted that this interview satisfied FRE 807 as "the residual exception to hearsay" which provides the evidence is not excluded if:

    (1) the statement is supported by sufficient guarantees of trustworthiness—after considering the totality of circumstances under which it was made and evidence, if any, corroborating the statement; and (2) it is more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.

    (all of which factual predicates are satisfied here, ToolGen argued).  ToolGen asserted three bases for establishing the interview's trustworthiness:  Dr. Doudna herself confirmed the article was written after she was interviewed; the sentiments contained in the interview were ones she had voiced in several other instances; and Dr. Doudna has never corrected or retracted she made in the interview, even in her deposition when given an opportunity to do so.

    ToolGen also asserted that this evidence should not be excluded because it is "highly probative of Dr. Doudna's contemporaneous thoughts regarding the doubts she had that CRISPR-Cas9 could be adapted for use in eukaryotic cells," citing United States v. U.S. Gypsum Co., 333 U.S. 364, 395–96 (1948), and the Board's own preference for contemporaneous statements on this very issue in Interference No. 105,048 and in the Decisions on Motions in Interference No. 106,115.

    In its October 15th reply, CVC directed its counterargument to ToolGen's "belated" attempt (in its view) to authenticate Dr. Carroll's YouTube video with reference to ToolGen Exhibit Nos. 1614 (the Innovative Genomics Institute website, Innovative Genomics Institute) and 1615 (Opening Screen of Ex. 1283 (Dana Carroll, Issues in CRISPR-Cas Editing, YOUTUBE, 32:42–32:57 (Nov. 4, 2017)).  The time to authenticate was August 5, 2021 (in response to CVC's timely objection) and the Board should not permit ToolGen to supplement its evidence with these attempts to corroborate, CVC argued.  CVC also rebutted ToolGen's argument that only 15 seconds of the Carroll lecture were to be excluded, saying that CVC had move to exclude the video "in its entirety" (emphasis in brief).  Rather, ToolGen submits a video "excerpt" unauthenticated as to "who excerpted it, and whether it still accurately portrays the original subject matter in its excerpted form" (emphasis in brief).

    As to the Doudna interview, CVC argued in its Reply that ToolGen's distinction in its Opposition that CVC's Motion did not cite "patent cases" is irrelevant because the rules regarding hearsay do not depend on the subject matter ("Hearsay is hearsay").  And as for ToolGen's invocation of FRE 807, CVC argued that:

    Courts have specifically found that mainstream media interviews edited for publication to a lay audience lack the traditional indicia of reliability that Rule 807 requires, because quotes in such publications are cherry-picked to give a sense of drama and "capture the interest of . . . readers, who might otherwise have little interest," rather than to present an accurate or fulsome account of events.

    citing New England Mut. Life Ins. Co. v. Anderson, 888 F.2d 646, 650 (10th Cir. 1989), and Ohio v. Roberts, 448 U.S. 56, 65 (1980); Horta v. Sullivan, 4 F.3d 2, 8 (1st Cir. 1993).  Moreover, CVC's quotations from Dr. Doudna direct the Board's attention to the number of times that Dr. Doudna did not validate the statements attributed to her, saying frequently "I don't know that to be true" or variants thereof.  Finally, to the extent that ToolGen relied on statements from other sources similar to the ones the interview had Dr. Doudna making CVC argues that those sources may be equally unreliable and cited Gehin v. Wisconsin Group Ins. Bd., 692 N.W.2d 572, ¶ 92 (Wis. 2005), for the principle that "bootstrap[ping] uncorroborated hearsay with uncorroborated hearsay would eviscerate the requirement that there be corroboration of hearsay in order for the hearsay evidence to form the basis of an agency's finding of fact").

    The Board will render its decision prior to Final Hearing in this Interference.

  • Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)

    By Kevin E. Noonan —

    Federal Circuit SealJoint inventorship has been called "one of the muddiest concepts in the muddy metaphysics of patent law" because the "exact parameters of what constitutes joint inventorship are quite difficult to define."  Mueller Brass Co. v. Reading Indus., 352 F. Supp. 1357, 1372 (E.D. Pa. 1972), aff'd, 487 F.3d 1395 (3d Cir. 1983).  The consequences of an improper (or improvident) determination of inventorship (and the sometime difficulties that can arise when a change of inventorship is delayed until a patent is being asserted at trial) is illustrated in the Federal Circuit's recent non-precedential decision in Horizon Medicines LLC v. Alkem Laboratories Ltd.

    The matter arose in ANDA litigation over Horizon's DUEXIS® product, an NSAID formulation used for administration to rheumatoid arthritis and osteoarthritis patients.  According to the opinion, the prior art recognized that chronic use of NSAIDs at dosages useful for pain relief and inflammation (such as ibuprofen, a "non-selective" NSAID) produced stomach ulcers.  (In a footnote the opinion sets forth a distinction between non-selective NSAIDs, which inhibit both known forms of cyclooxygenase (COX), and "selective" NSAIDs, which only recognize the COX species that are not present in the mucus lining of the stomach and thus are not associated with stomach ulcers.)  However, selective NSAIDs were found to be disadvantageous due to cardiovascular complications associated with their use.  Horizon's claimed non-selective NSAID formulations avoided the ulcer-producing effects of non-selective NSAID administration by co-formulation with famotidine.  In ANDA litigation Horizon asserted U.S. Patent Nos. 8,067,033 and 8,067,451; claim 1 of each patent was set forth in the opinion as being representative:

    '033 patent:

    1.  A pharmaceutical composition comprising
        a first portion that comprises 800 mg ibuprofen and a second portion that comprises 26.6 mg famotidine,
        wherein the surface area of direct physical contact between ibuprofen and famotidine does not exceed 130 mm2,
        wherein no more than about 1% sulfamide is present when the composition is stored at 40°C and 75% relative humidity for a period of one month,
        wherein the composition is formulated so that release of both the ibuprofen and the famotidine occurs rapidly at about the same time,
        wherein none of the composition, the famotidine, and the ibuprofen is enterically coated or formulated for sustained or delayed release, and
        wherein the composition is for use according to a TID (three times per day) administration schedule for reducing the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for an ibuprofen-responsive condition.

    '451 patent:

    1.  An oral dosage in tablet form comprising
        a first portion that comprises 800 mg ibuprofen and a second portion that comprises 26.6 mg famotidine,
        wherein a barrier layer comprising hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide surrounds the second portion completely separating it from the first portion . . .

    Relevant to the District Court's determinations, use of the combination of a non-selective NSAID and famotidine was known in the art to reduce stomach ulceration upon prolonged use.  The opinion explains that this advantageous combination was also known to degrade due to chemical incompatibility between these two compounds.  The claimed formulations achieved their greater stability by minimizing the surface area of direct physical contact between the incompatible ingredients; as set forth in the opinion the product contained "a famotidine core, an ibuprofen shell, and an Opadry® White barrier layer in between."

    The District Court found the asserted claims (claims 1, 8, 11, and 14) of the '033 patent to be invalid for obviousness and the asserted claims (claims 1–3 and 8–10) of the '451 patent not to be infringed.  Horizon appealed.

    The Federal Circuit affirmed the District Court's invalidity and non-infringement determinations in an opinion by Judge Dyk joined by Judges O'Malley and Hughes.  The District Court's obviousness determination was based on U.S. Patent Application Pub. No. 2007/0043096 A1, which Horizon argued was not properly prior art and thus the District Court had committed legal error in considering it to be so.  Because the patents-in-suit and the cited prior art patent application were filed prior to enactment of the Leahy-Smith America Invents Act, the District Court and Federal Circuit applied the novelty provisions of the 1952 Patent Act in finding the '096 application to be prior art.  The '033 patent names Inventor Tidmarsh while the '096 application names Tidmarsh and a second inventor, Golombik.  (In a footnote the Federal Circuit explains there were additional inventors named in each but that their status did not need to be resolved because resolution of the Tidmarsh/Golombik inventorship status was outcome determinative.)  At trial Horizon moved under 35 U.S.C. § 256 to add Golombik as an inventor on the '033 patent, a motion the district court denied.  Horizon's argument on appeal was that if Tidmarsh and Golombik had invented formulations comprising 800 mg ibuprofen and 26.6 mg famotidine (as set forth in the '096 application) then both inventors perforce were also inventors of the invention described and claimed in the '033 patent (which recites formulations comprising 800 mg ibuprofen and 26.6 mg famotidine).  The Federal Circuit rejected this argument.  The opinion notes that generally "the inventors named in an issued patent are presumed to be correct" and this presumption can be overcome only in the face of clear and convincing evidence, citing Caterpillar Inc. v. Sturman Indus., Inc., 387 F.3d 1358, 1377 (Fed. Cir. 2004).  Mere inventor testimony is not enough to overcome this presumption, according to the Court, and "some form of corroboration must be shown"; see EmeraChem Holdings, LLC v. Volkswagen Grp. of Am., Inc., 859 F.3d 1341, 1346 (Fed. Cir. 2017) (similar considerations provide the rationale for like requirements in interferences; see, Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1171 (Fed. Cir. 2006)).  Moreover, the opinion states that "[o]ur cases are clear that inventing something in an earlier patent or patent application does not automatically make one an inventor of patents that incorporate the earlier invention," citing Eli Lilly and Co. v. Aradigm Corp., 376 F.3d 1352, 1358, 1362 (Fed. Cir. 2004).  The Court was unpersuaded by Horizon's reliance on Pannu v. Iolab Corp., 155 F.3d 1344 (Fed. Cir. 1998), to the effect that Tidmarsh and Golombik were engaged in a "collaborative enterprise," on the grounds that unlike in Pannu "[t]he only support for Golombik's contribution to the '033 patent is testimony by Tidmarsh and Golombik."  The Federal Circuit found no clear error by the District Court based on the totality of the evidence, including putative inventor testimony (which the District Court had characterized as "non-specific," "convenient, uncorroborated, and not very credible").

    The Federal Circuit also rejected Horizon's non-obviousness arguments taking the '096 application as proper prior art.  These arguments were grounded on whether the skilled worker would have had a reasonable expectation of success in achieving formulations having the stability of the claimed formulations.  This expectation arose, according to the District Court as affirmed by the Federal Circuit, from another prior art reference that disclosed using the same "tablet-in-tablet" formulation claimed in the '033 patent to achieve increased stability for combinations of drugs "similar to ibuprofen and famotidine" (as supported by expert witness testimony).  The Federal Circuit found no clear error in these District Court determinations either.

    And the Federal Circuit dismissed consideration of Horizon's arguments regarding non-infringement of the '033 patent as moot in view of their affirmance of the invalidity of the '033 patent's asserted claims.

    Regarding the '451 patent, Horizon argued that the District Court erred in construing the term "comprising" as recited in the claim with regard to the barrier layer limitation to mean "consisting essentially of."  The Federal Circuit rejected this argument, first, because the panel held that Horizon had not established harmful error in its briefing, and second, "the prosecution history of the '451 patent supports the district court's construction."  Specifically, the opinion points to "multiple exchanges with the Examiner" where Horizon made amendments to overcome rejections over the prior art that purportedly "focus[ed] on an embodiment of the invention that uses Opadry® White (YS-1-7003) as a barrier layer."  In view of this history the panel found no clear error in the District Court's construction nor the factual basis for its finding of non-infringement.

    Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)
    Nonprecedential disposition
    Panel: Circuit Judges Dyk, O'Malley, and Hughes
    Opinion by Circuit Judge Dyk

  • CardioNet, LLC v. InfoBionic, Inc. (Fed. Cir. 2021)

    By Kevin E. Noonan —

    Federal Circuit SealThe Federal Circuit continued its stringent (if misguided) application of the scope of subject matter eligibility by invalidating claims asserted in CardioNet, LLC v. InfoBionic, Inc.

    The case arose over InfoBionic's alleged infringement of CardioNet's U.S. Patent No. 7,099,715; claims 1, 11, and 20 are illustrative:

    1.  A machine-implemented method comprising:
        identifying heart beats in a sensed cardiac signal;
        activating a frequency domain T wave filter, used in said identifying heart beats, in response to a message from a monitoring station generated at least in part based upon discovery of a predetermined characteristic in the sensed cardiac signal; and
        outputting information corresponding to the identified heart beats to a communications channel of a distributed cardiac activity monitoring system.

    11.  A distributed cardiac activity monitoring system comprising:
        a monitoring apparatus including a communications interface, a real-time QRS detector, a frequency domain T wave filter, and a selector that activates the T wave filter with respect to the real-time QRS detector in response to a message, wherein the activated frequency domain T wave filter preprocesses a cardiac signal provided to the realtime QRS detector; and
        a monitoring station that communicatively couples with the monitoring apparatus via the communications interface and transmits the message to the monitoring apparatus to activate the frequency do-main T wave filter based at least in part upon a predetermined criteria.

    20.  A cardiac monitoring apparatus comprising:
        a communications interface;
        a real-time heart beat detector;
        a frequency domain T wave filter; and
        a selector that activates the frequency domain T wave filter with respect to the real-time heart beat detector in response to a message, wherein the activated frequency domain T wave filter preprocesses a cardiac signal provided to the real-time heart beat detector.

    The District Court granted summary judgment of non-infringement but held the claims not to be invalid under 35 U.S.C. § 101 for failure to recite eligible subject matter.  Both parties appealed.  

    The Federal Circuit vacated the District Court's non-infringement judgment and remanded for entry of judgment that the '715 patent claims were invalid on subject matter eligibility grounds, in an opinion by Judge Lourie, joined by Judges Dyk and O'Malley.  The Court applied the Supreme Court's Mayo/Alice test (as it has grown under the Federal Circuit; see Alice Corp. v. CLS Bank Int'l, 573 U.S. 208, 217 (2014), and Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 70–73 (2012)) in reaching its invalidity conclusion.  The opinion sets forth the District Court's reasoning that, while in Step 1 of the Mayo/Alice test claim 20 is "directed to" an abstract idea ("filtering raw cardiogram data to optimize its output"), under Step 2 the claim recites "an inventive concept sufficient to transform the abstract idea into patent-eligible subject matter."  The basis for this conclusion is that the claim is "tied to a machine" and thus satisfies the "machine or transformation" test under Bilski v. Kappos.  The Court agrees with regard to Step 1 reciting an abstract idea, which the Court characterizes as "the abstract idea of filtering patient heartbeat signals to increase accuracy."  This, "at bottom" according to the Court "requires only basic mathematical calculations, such as 'de-compos[ing] a T wave into its constituent frequencies and multipl[ying] them by a filter frequency response.'"  In this analysis the Court goes beyond what is claimed (an apparatus) and focuses on how the apparatus achieves its aims (thus avoiding the question of whether this is how the mathematical formula is applied (which was sufficient under Diamond v. Diehr to render a method claim patent-eligible), reminiscent of the Court's troubling type of reasoning in American Axle & Mfg. v. Neapco Holdings LLC.  The opinion, applying precedent across disciplines denigrates the inventiveness of the improvement in the art by cherry-picking Justice Thomas's statement in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013), that "such calculations, even if '[g]roundbreaking,' are still directed to an abstract idea."

    The opinion illustrates how the Court has gone astray in addressing CardioNet's additional arguments.  For example, to the argument that the apparatus uses the mathematical formula to achieve an improvement in an ECG that does not mistake T waves for R waves the opinion asserts "[t]o qualify as 'a patent-eligible improvement,' the invention must be directed to a specific improvement in the computer's functionality, not simply to use of the computer 'as a tool' to implement an abstract idea."  Of course, what is a computer except a tool; if the computer was just used to produce mathematical solutions the Court's rationale may have made some sense.  But the Court's reasoning ignores that the mathematical formula is used to produce an improved ECG, which certainly seems like a desirable, inventive, patent-eligible technical achievement (not to mention a benefit for patients whose physicians can rely on more accurate ECGs).

    The Court is on firmer ground (albeit one more properly sounding in indefiniteness rather than ineligibility) when it critiques the claim for not reciting when and how the T wave filter is activated (which apparently is the result of determination by an operator, e.g., in claim 1: "activating a frequency domain T wave filter, used in said identifying heart beats, in response to a message from a monitoring station generated at least in part based upon discovery of a predetermined characteristic in the sensed cardiac signal").

    The true colors of the determination of ineligibility are revealed in the opinion's discussion distinguishing claims here from the claims held patent eligible in CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020).  The distinction, sounding in novelty rather than ineligibility, is that "[i]n that case . . . there was no intrinsic evidence that the claimed technique had ever been used" whereas here "InfoBionic points to evidence that the use of a filter to perform mathematical functions was not a new activity."

    Turning to Alice Step 2, the Court dismissed CardioNet's argument that the T wave filter was "innovative" (i.e., a frank novelty argument) based on disclosure in the '715 specification seemingly to the contrary (but nonetheless engrafting the eligibility argument into another species of novelty arguments without the need for a proper novelty analysis).  The speciousness of the Court's rationale is illustrated by the conclusion that "'[a] claim for a new abstract idea,' here, a mathematical calculation, 'is still an abstract idea'" citing Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151 (Fed. Cir. 2016) (not a case involving similar subject matter).  Once again patentee's arguments were thwarted by statements in their own specification, wherein "the specification explains that the other claimed components are conventional" (such statements being fatal under the Court's analysis that eschews considering claims as a whole, in contravention to  Diamond v Diehr).  And while the Supreme Court validated the machine or transformation test (while insisting it was not the exclusive test), by now the Federal Circuit appears content to ignore that precedent as well, in favor of their determinations that "not all 'transformations or machine implementations infuse an otherwise ineligible claim with an "inventive concept,"'" citing Solutran, Inc. v. Elavon, Inc., 931 F.3d 1161, 1169 (Fed. Cir. 2019) (citing DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014) and relying on the Supreme Court's holding that the test is not dispositive.  The opinion further states that:

    Here, although claim 20 is technically tied to a machine (a cardiac apparatus) its ultimate focus is to "preprocess[] a cardiac signal" using a "T wave filter," which, as explained above, is an abstract idea.

    Under standards like "ultimate focus" and "inventive concept," claims to almost anything are capable of being invalidated on subject matter eligibility grounds (and indeed are being invalidated; see Yu v. Apple).

    There was a time, when the expectations of the Federal Circuit were higher with regard to the Court's mandate from Congress concerning patent law and the Court's purported expertise, that a decision like this one would have produced confusion, chagrin, or outrage with how the Court applied dubious Supreme Court decisions on subject matter eligibility in invalidating the asserted claims.  Nowadays, after almost a decade (the lost decade?) of the Court's fractured subject matter eligibility jurisprudence that has spread like a stain to encompass almost every class of subject matter possible, the only emotions that arise are sadness; perhaps with the passage of time this will evolve into Elvis Costello's aphorism "I used to be disgusted/Now I try to stay amused."  But not yet.

    CardioNet, LLC v. InfoBionic, Inc. (Fed. Cir. 2021)
    Nonprecedential disposition
    Panel: Circuit Judges Lourie, Dyk, and O'Malley
    Opinion by Circuit Judge Lourie

  • U.S. Trade Representative Responds to Letters from Senators Regarding TRIPS Waiver

    By Donald Zuhn —

    U.S. Trade RepresentativeLast week, United States Trade Representative Katherine C. Tai responded to a series of letters sent by a group of Senators regarding a proposal by India and South Africa to waive certain provisions of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in relation to prevention, containment, or treatment of COVID-19.  The most recent letter to Ambassador Tai was sent on October 7, 2021 by Sen. Thom Tillis (R-NC), the Ranking Member of the Subcommittee on Intellectual Property of the Senate Committee of the Judiciary.  Sen. Tillis' letter included as Annexes three prior letters sent to Ambassador Tai:  a May 19, 2021 letter sent by a group of sixteen Senators, a July 14, 2021 letter sent by Sen. Tillis and Sen. Tom Cotton (R-AR), and an April 16, 2021 letter sent by Sen. Tillis (all three letters were also addressed to the Secretary of the Department of Commerce, Gina M. Raimondo).

    In their May 19 letter, a group of sixteen Senators* called the Biden Administration's decision to support the waiver of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement in relation to the prevention, containment, or treatment of COVID-19 "disastrous," and declared that:

    The waiver, which is not limited to vaccines, will do nothing to end this global pandemic.  Instead, it will undermine the extraordinary global response that has achieved historically remarkable results in record time and our nation's global leadership in the technologies, medicines, and treatments of the future.

    The Senators also stated that:

    It is not surprising that China, India, and South Africa want to steal our intellectual property and medical technology.  What is surprising is that an American president, especially one who claims to be a "jobs" president, would force American companies to give their medical technology and manufacturing processes to foreign adversaries like China [emphasis in original].

    In the letter, the Senators posed ten questions intended "to help us better understand this decision to support intellectual property theft and forced technological transfer," and they requested a response to those questions "by no later than June 19, 2021."

    In the July 14 letter from Sen. Cotton and Sen. Tillis, the two Senators noted that they had not yet received a formal response to their May 19 letter with answers to their questions, but instead had "received a cursory, perfunctory, and dismissive response from your offices," which the Senators noted "was totally inadequate and failed to respond to congressional oversight."  They asked for a formal reply "by no later than July 31, 2021," and warned that "[f]ailure to give specific answers to our questions . . . will result in us taking appropriate action to ensure congressional oversight of this important matter."

    In responding to the Senators' letters, Ambassador Tai indicated in her November 8, 2021 letter that "[t]he Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports a waiver of those protections for COVID-19 vaccines."  She added, however, that "the Biden-Harris Administration is exploring every avenue to coordinate with the global community and is evaluating the efficacy of proposals in multilateral fora, including the WTO, by their true potential to save lives, end this pandemic, and respond to the next one."  Ambassador Tai stated that "[t]he Administration believes strongly in intellectual property (IP) protections, biopharmaceutical innovation, and the importance of safeguarding American innovation from illicit acquisition," but noted that "[t]he decision to support a waiver of IP protections for COVID-19 vaccines reflects the extraordinary circumstances of this pandemic."  Ambassador Tai also contended that "[t]he need for increased vaccine production does not adversely affect American pharmaceutical workers."  The Ambassador's letter closes by acknowledging that although the Administration is committed to continuing to work with WTO members given the extraordinary circumstances of the pandemic, it "will be clear-eyed about potential risks as we enter text-based negotiations."

    * Senators Cotton, Tillis, Charles E. Grassley (R-IA), Mike Crapo (R-ID), James Lankford (R-OK), Mike Lee (R-UT), Joni K. Ernst (R-IA), Ben Sasse (R-NE), Dan Sullivan (R-AK), Kevin Cramer (R-ND), Todd Young (R-IN), Richard Burr (R-NC), Roger F. Wicker (R-MS), Marsha Blackburn (R-TN), M. Michael Rounds (R-SD), and Steve Daines (R-MT).

    For additional information regarding this topic, please see:

    • "U.S. Chamber of Commerce Urges Administration to 'Double Down' on Global Vaccine Distribution," November 3, 2021
    • "Is This the WTO Waiver End Game?" July 25, 2021
    • "BIO Declaration on Global Access to COVID-19 Vaccines and Treatments and Role of IP," June 24, 2021
    • "GOP Legislators Write in Opposition to Proposed TRIPS Waiver," May 16, 2021
    • "Population of Patents at Risk from Proposed WTO Patent Waiver," May 12, 2021
    • "Sen. Daines Urges Biden Administration to Withdraw Support for COVID-19 IP Waiver," May 12, 2021
    • "Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver," May 10, 2021
    • "If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?" May 9, 2021
    • "The Road to Hell Is Paved with What Everybody Knows," May 6, 2021
    • "BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver," May 6, 2021
    • "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines," May 5, 2021
    • "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)," April 26, 2021
    • "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal," April 21, 2021
    • "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021
    • "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
    • "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021
    • "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021

  • Conference & CLE Calendar

    CalendarNovember 16, 2021 – "Drug Patent Linkage & Drug Patent Term Extension — Current Situation Around the World" (Intellectual Property Owners Association) – 9:00 am to 10:00 am (ET)

    November 16, 2021 – "Recent IP Major Issues in South Korea" (Lee & Ko IP) – 11:00 am to 12:00 pm (EST)

    November 16, 2021 – "International Exchange: Promoting the Inclusion of Women in Intellectual Property" (U.S. Patent and Trademark Office) – 4:00 pm to 6:00 pm (ET)

    November 17, 2021 – "Examiner Procrastination at the USPTO: How End-Loading Impacts Your Organization" (Juristat) – 1:00 to 2:00 pm (ET)

    November 18, 2021 – "International Innovation and Patents: TRIPS and Vaccine Waivers" (Federal Circuit Bar Association) – 11:00 am to 12:00 pm (ET)

    November 18, 2021 – "Recent IP Major Issues in South Korea" (Lee & Ko IP) – 11:00 am to 12:00 pm (EST)

    November 18, 2021 – "Leveraging Separate IPR Counsel to Maximize Litigation Success" (Fitch Even) – 12:00 pm to 1:00 pm (ET)

    November 18, 2021 – "Making Better Lawyers by Fostering Diversity and Inclusion in the Legal Profession: A Conversation Between IPO and the Minority Corporate Counsel Association" (Intellectual Property Owners Association Diversity and Inclusion Committee) – 3:00 pm to 4:00 pm (ET)

  • Webinar on Examiner Procrastination at USPTO

    JuristatJuristat will offer a one-hour webinar entitled "Examiner Procrastination at the USPTO: How End-Loading Impacts Your Organization" on November 17, 2021 from 1:00 to 2:00 pm (ET).  The webinar will address the following topics:

    • How Juristat calculates end-loading rates and related metrics
    • The impact end-loading has on OA volume and prosecution strategy
    • Which examiners procrastinate the most and get more difficult at the end of the quarter
    • And which assignees are most impacted by end-loading

    Those interested in registering for the webinar can do so here.

  • FCBA Remote Program on TRIPS and Vaccine Waivers

    Federal Circuit Bar Association_2The Federal Circuit Bar Association (FCBA) will be offering a remote program entitled "International Innovation and Patents: TRIPS and Vaccine Waivers" on November 18, 2021 from 11:00 am to 12:00 pm (ET).  Robert Stoll of Faegre Drinker Biddle & Reath LLP will moderate a panel consisting of Rt Hon. Sir Robin Jacob, Sir Hugh Laddie Chair of Intellectual Property Law, University College London; Ansgar Ohly, Professor, Ludwig Maximilian University of Munich; Roberto Rodrigues of Licks Attorneys; and Corey Salsberg of Novartis International AG.

    The webinar is complimentary for FCBA and EPLAW members and $75 for non-members.  Those interested in registering for the program, can do so here.

  • Webinar on Engaging Litigation or Separate Counsel in IPR Proceedings

    Fitch EvenFitch Even will be offering a webinar entitled "Leveraging Separate IPR Counsel to Maximize Litigation Success" on November 18, 2021 from 12:00 pm to 1:00 pm (ET).  Timothy P. Maloney and Paul B. Henkelmann of Fitch Even will discuss the following topics:

    • Pros and cons of engaging litigation counsel or separate counsel for IPR proceedings
    • Critical issues common to both litigation and IPR proceedings that require close coordination
    • Practical guidance when working with separate litigation or IPR counsel
    • Strategies for improving cooperation between litigation and IPR counsel

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

  • IPO Webinar on Drug Patent Linkage & Drug Patent Term Extension Around the World

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Drug Patent Linkage & Drug Patent Term Extension — Current Situation Around the World" on November 16, 2021 from 9:00 am to 10:00 am (ET).  Jaeyoung Im of Voronoi Inc., Toby Mak of Tee & Howe Intellectual Property Attorneys, and Corey Salsberg of Novartis will introduce the details of the new Chinese drug patent linkage system arising as part of China's implementation of IP reforms required by the U.S.—China Phase I Trade Agreement.  The panel will describe how the system works, share views on whether it is likely to be effective, and provide updates on the latest developments in actions that have been brought under it, and also discuss the drug patent linkage system of South Korea and provide a comparison with U.S. patent linkage measures.

    The registration fee for the webinar is $150 for non-members or free for IPO members (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.