• 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

  • 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

  • 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)

  • 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.

  • 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.

  • 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 #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.

  • Lee & KoLee & Ko IP will be offering a series of webinars on "Recent IP Major Issues in South Korea" on November 16 and 18, 2021.  Four sessions are being offered in the series:

    November 16:
    • 11:00 am to 11:30 am (EST) — Major Court Precedents and Recent Trends in KIPO regarding Patent Term Extension of Drug Patent
    • 11:30 am to 12:00 pm (EST) — Practice on Al and Software Patents

    November 18:
    • 11:00 am to 11:30 am (EST) — New Developments in Trademark and Design Practice
    • 11:30 am to 12:00 pm (EST) — Description Requirements for Parameter Invention

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • USPTO SealThe U.S. Patent and Trademark Office will offer a webinar entitled "International Exchange: Promoting the Inclusion of Women in Intellectual Property" on November 16, 2021 from 4:00 pm to 6:00 pm (ET).  Representatives from the USPTO, IP Australia, the Canadian IP Office, the IP Office of the Philippines, the Mexican Institute of Industrial Property, the IP Office of New Zealand, the Industrial Property Protection Directorate of Jordan, and other national offices will discuss the underrepresentation of women inventors in the patent system worldwide and explain how some countries have succeeded in increasing the participation rate of women in their IP systems.  Topics to be discussed will include:

    • Strategies for increasing the participation of women in the IP system
    • How to recruit, retain, and promote women in IP fields

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

  • IPO #2The Intellectual Property Owners Association (IPO) Diversity and Inclusion Committee will offer a one-hour webinar entitled "Making Better Lawyers by Fostering Diversity and Inclusion in the Legal Profession: A Conversation Between IPO and the Minority Corporate Counsel Association" on November 18, 2021 from 3:00 pm to 4:00 pm (ET).  Serena Farquharson-Torres of Bristol-Myers Squibb Co.; Sophia Piliouras of Minority Corporate Counsel Association; Elaine Spector of Harrity & Harrity, LLP; and Christopher Suarez of Steptoe & Johnson LLP will provide practical insights and tips to lawyers who seek to improve their practices by becoming better stewards of diversity and inclusion in the profession.

    There is no registration fee for the webinar.  However, those interested in attending the webinar should register here.