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  • Broad Reply No. 2 to CVC’s Opposition No. 2 to Broad’s Motion No 2 to Substitute the Count

    By Kevin E. Noonan —

    Broad InstituteOn March 23rd Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") filed its Reply to Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") Motion No. 2 in Opposition to Broad's Substantive Motion No. 2 to Substitute the Count.

    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 Broad made was 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 in the latter versions, the "targeter-RNA" and "activator-RNA" as recited in the proposed Count are not covalently linked).  Broad argued that its Proposed Count 2 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 argued 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 Broad contended current Court 1 (in either alternative) does not.

    Broad's argument in support of its motion was that Count 1 is too narrow for encompassing just a subset of the parties' involved claims.  In particular, the brief asserted that most of Broad's involved clams encompass "non-limited" RNA systems and methods.  Similarly, the brief argued 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.  Broad asserted that Count 1 does not permit Broad to rely on its earliest and best proofs of invention, which the brief stated is "plainly unfair."  This unfairness would preclude Broad from establishing what the brief termed "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 declared 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."

    CVC in its Opposition argued that Proposed Count 2 "goes far beyond converting Count 1 into a generic-guide count."  Instead, according to CVC, "it transforms Count 1 into a method so broad that it no longer requires formation of the DNA-targeting complex that includes crRNA, tracrRNA, and Cas9."  In addition, according to CVC, Proposed Count 2 does not require that the CRISPR-Cas9 complex even have an effect on the target DNA; rather, it recites that "'a product of the DNA' is altered in some unspecified way" (emphasis in brief), which could include (according to CVC) "alterations to RNA or protein caused by processes that are unrelated to the activity of CRISPR-Cas9" including contamination.  And the changes the Broad has effected in Proposed Count 2 "have nothing to do with whether the RNA limitation is single-molecule or generic, Broad's only purported reason for needing a new count" according to CVC.

    CVC further argued that the Broad's motion is contrary to the provisions of precedential Board decision, Louis v. Okada, 59 U.S.P.Q.2d 1073 (B.P.A.I. 2001).  Under Louis, a party must satisfy a three-prong test:  "'(1) should make a proffer of the party's best proofs, (2) show that such best proofs indeed lie outside of the scope of the current count, and (3) further show that the proposed new count is not excessively broad with respect to what the party needs for its best proofs.'"  CVC's position (explicated in the brief) is that the Broad failed to provide what Louis required for the "significant alterations" made to Count 1 resulting in Count 2.

    The brief summarizes these unnecessary changes as:

    • "first, Broad has inexplicably eliminated structural and functional limitations that specify the formation of the three-component DNA-targeting complex that includes crRNA, tracrRNA, and Cas9."

    • "Second, Broad has inexplicably eliminated the requirement that this complex have activity with effects at the DNA level (e.g., cleaving or editing or modulating transcription of DNA).  Rather, Proposed Count 2 encompasses merely altering a "productof the DNA molecule" in unspecified ways. Problematically, this breadth includes alterations to downstream products of DNA, such as RNA and protein, that have nothing to do with the activity of the CRISPR-Cas9 system."

    • "Third, Broad has inexplicably converted Count 1 from a 'cell' or 'system' to a 'method.'"

    • "Fourth, Broad has inexplicably eliminated the alternative language in CVC's part of Count 1 reciting 'ora nucleic acid comprising a nucleotide sequence comprising . . . .'"

    CVC further asserts that the Broad has not shown that Proposed Count 2 is patentable over the prior art.

    In its Reply, Broad asserts that CVC did not dispute that the "major advance" at issue is which party invented successful CRISPR in eukaryotic cells, and that this "breakthrough" was not limited to single RNA embodiments of the technology.  The brief asserts that current Count 1 "precludes reliance on dual-molecule proofs" (unfairly to Broad) but at the same time this Count "puts at risk all of Broad's claims," which might be considered paradoxical until it is realized that Broad submitted other Motions asking that many if not most of Broad's claims would not correspond to Proposed Count 2.

    The brief characterizes CVC's arguments as "nitpick[ing]" and alleges that in CVC's interpretation CRISPR as recited in Count 1 is "so broad it no longer requires a targeting complex that includes crRNA, tracrRNA, and Cas9" (an interpretation that CVC's expert allegedly does not share, which would be curious at least).  But even though Broad characterizes these nitpicks as "immaterial" it states that "addressing them would require only small adjustments that could easily be adopted sua sponte by the PTAB."  With regard to CVC's purported attempt to limit the scope of the interference to single-molecule embodiments, Broad also asserts that CVC argued that Broad's 2011 experiments were limited to such embodiments, again arguing that CVC's expert testified to the contrary and characterizing CVC's assertions as being "only attorney argument."  The basis for CVC's incorrect arguments in this regard Broad asserts to be an incorrect interpretation of the term "guide RNA" as being limited to single-molecule RNA species.

    Broad's synopsis of its reasons for its Motion No. 2 should be granted is:

    Broad requests the PTAB to adopt Proposed Count 2 to ensure that, should this interference go forward, claims directed to the broad invention of use of CRISPR-Cas9 in eukaryotic cells, as at issue here, are awarded to the party that first invented use of CRISPR-Cas9 in eukaryotic cells.  CVC seeks an interference where claims to use of CRISPR-Cas9 in eukaryotic cells (regardless of type of RNA used) are awarded not to the first inventor of that subject matter, but rather to the party that first created one specific embodiment for which CVC believes it has the best proofs (a single-molecule RNA embodiment).  Failing to substitute a generic count for Count 1 would be unjust to Broad and antithetical to the purpose of the Interference, to determine "which of the competing parties was the first to invent the duplicative subject matter."  Eli Lilly & Co. v. Bd. of 15 Regents of Univ. of Wash., 334 F. 3d 1264, 1267 (Fed. Cir. 2003) [all emphasis in brief].

    Turning to specific arguments against particular features of CVC's brief with which Broad takes issue, the brief (as it must) cites these particular arguments chapter and verse (or more accurately, page and line).  The first is that all Broad's claims are directed towards single-molecule embodiments, supported according to Broad solely by attorney argument.  Broad argues that both parties have involved claim "indisputably directed to generic RNA guides" (i.e., both single- and dual-molecule guide RNA embodiments).  Broad asserts that CVC's misinterpretation of "guide RNA" ignores the plain meaning and "misreads the intrinsic evidence," despite (according to Broad) the use of the term in the Jinik 2012 reference (which Broad states was "perhaps the most important CRISPR publication up to that point and widely read by skilled artisans") as referring to the naturally occurring guide RNA.  Broad also asserts that CVC misinterpreted disclosure in its involved patent, which disclosure "does not rise to an 'expression of manifest exclusion or restriction, representing a clear disavowal of claim scope,'" citing Thorner v. Sony Computer Entertainment America LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012).

    The brief also broadly characterizes CVC's criticisms of Proposed Count 2 as "baseless" regarding the four "alleged" differences that "have nothing to do with the single-molecule format of the RNA."  Broad says in response that its Proposed Count 2 is "materially the same" as current Count 1 with regard to these four aspects, enumerating the its differences with CVC's interpretation for each:

    • First, that Proposed Count 2 requires contacting a DNA target with all three components of the CRISPR system (Cas9, crRNA, and tracrRNA) (citing "specific language" of Proposed Count 2 in support);

    • Second, that Proposed Count 2 requires the occurrence of effects at the target DNA ("cleaving or editing or modulating transcription of DNA") (again relying heavily on CVC's expert's testimony purportedly contrary to CVC's arguments);

    • Third, that the change from "cell" or "system" in Count 1 to "method" is "immaterial":

    • Fourth, that eliminating language in Count 1 from Proposed Count 2, recited in the alternative, "a nucleic acid comprising a nucleotide sequence" does not narrow the Count.

    Broad also argues that CVC's allegation that Proposed Count 2 is broader than the claims in interference is "based on its erroneous interpretation" of the Proposed Count, which is that the Count does not require tracr RNA (which Broad asserts it does).

    With regard to Broad's burden in being granted the relief requested by the PTAB, Broad argues that CVC's challenge regarding Broad's "best proofs" corresponding better to Proposed Count 2 than the current Count are "legally and factually incorrect."  Broad supports this allegation by returning to its earlier argument that CVC was wrong in asserting that Broad's earliest eukaryotic application of CRISPR technology was performed with single-molecule guide RNA (calling it "meritless").  The brief sets forth a portion of Inventor Zhang's declaration to illustrate the point:

    2020-04-21 Image
    As Broad argues, this diagram shows three components of CRISPR:  Cas9, and separate tracr and crRNAs.

    The brief also challenges CVC's argument that Broad had not shown its best proofs are outside the scope of Count 1 (as it is required to do to obtain the requested relief) and that CVC is wrong to assert that Broad was obligated to prove its dual-molecule guide RNA experiments were performed before its single-molecule guide RNA experiments.

    The brief specifically addresses CVC's citation of Louis v. Okada, 59 U.S.P.Q.2d 1073 (B.P.A.I. 2001), by asserting that Louis explicitly was not adopted as part of the Board Rules despite a proposal to do so and even if CVC was correct Broad's proffer was sufficient under the rules the PTAB actually adopted.

    Finally, Broad argues that CVC did not establish that Broad had failed to show Proposed Count 2 to be patentable; that CVC had not even contested that Broad is not entitled to the benefit of the Zhang B1 reference (its earliest provisional application); and that contrary to CVC's argument a single-molecule Count would not be patentably distinct from a non-limited count.

  • Thryv, Inc. v. Click-to-Call Technologies, LP (2020)

    By Kevin E. Noonan —

    Supreme Court Building #2Today, in Thryv, Inc. v. Click-to-Call Technologies, LP, the Supreme Court ruled that the provisions of 35 U.S.C. § 315(b), which preclude a petitioner from filing an inter partes review petition more than one year after being served with a complaint alleging infringement, are barred from judicial review under 35 U.S.C. § 314(d).  The Court's decision reversed an en banc Federal Circuit opinion that the time bar was reviewable, Wi-Fi One, LLC v. Broadcom Corp., as well as the panel decision in the case at issue below.

    The case arose after a complicated history, involving U.S. Patent No. 5,818,836, directed to methods for anonymizing telephone calls.  The patent had been involved in litigation in 2001 involving a predecessor in interest to parties here, but that case had been dismissed without prejudice.  When Thryv filed its petition for inter partes review in 2013, Click-to-Call argued that this earlier suit precluded the Patent Trial and Appeal Board from instituting the IPR under the provisions of 35 U.S.C. § 315(b), which provides in relevant part:

    §315(b) Patent Owner's Action.— An inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.

    The Board disagreed, instituted the IPR, and invalidated thirteen of the '836 patent claims under §§ 102 or 103.  Click-to-Call appealed, and the Federal Circuit dismissed the appeal for lack of jurisdiction under § 314(d):

    §314(d) No Appeal.— The determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.

    Click-to-Call petitioned for certiorari but in the interim the Supreme Court had decided Cuozzo Speed Technologies, LLC v. Lee and accordingly granted the petition, vacated the Federal Circuit's judgment and remanded for consideration in view of Cuozzo.

    Meanwhile, the Federal Circuit decided en banc in Wi-Fi One that the § 315(b) time bar was not "closely related" to the institution decision falling within the scope of § 314(a) and thus that the Board's determination of whether an IPR was reviewable was subject to the Court's review.  Accordingly, the Court granted a panel rehearing that decided that the 2001 infringement action started the one-year clock and the IPR was time-barred under § 315(b).  Today's majority opinion cited the Federal Circuit dissent in Wi-Fi One by Judges Hughes, Lourie, Bryson, and Dyk, that "§314(d) conveys Congress' 'clear and unmistakable' 'intent to prohibit judicial review of the Board's [inter partes review] institution decision.'"  The Court's opinion also notes in a footnote that the Federal Circuit in its now overruled en banc WiFi One opinion held that the time bar could be triggered by a compliant that was voluntarily dismissed without prejudice, but that the Court's opinion today does not reach this issue.

    The Supreme Court granted certiorari to consider the issue of whether § 314(d) precluded appellate review of the time bar determination by the PTAB under § 315(b).  In an opinion by Justice Ginsberg, joined by the remainder of the Court except for Justice Gorsuch who wrote a dissent in which Justice Sotomayor joined, the Court found that § 314(d) precluded appellate review of the § 315(b) time bar.

    Justice Ginsberg's opinion was succinct:

    The agency's application of § 315(b)'s time limit, we hold, is closely related to its decision whether to institute inter partes review and is therefore rendered nonappealable by § 314(d).

    The Court's basis for this decision was the statutory language, that § 314(d) renders "final and nonappealable" the Director's decision whether to institute an inter partes review, a holding the Court attests is consistent with Cuozzo:

    [O]ur interpretation applies where the grounds for attacking the decision to institute inter partes review consist of questions that are closely tied to the application and interpretation of statutes related to the Patent Office's decision to initiate inter partes review.

    According to the majority, the time bar question is "closely tied" to the statutory provisions precluding judicial review because § 315(b) sets forth a circumstance in which "[a]n inter partes review may not be instituted."  The opinion finds that "[w]e need not venture beyond Cuozzo's holding that §314(d) bars review at least of matters 'closely tied to the application and interpretation of statutes related to' the institution decision, for a §315(b) challenge easily meets that measurement."  The opinion calls the time bar "integral to, indeed a condition on, institution" in support of its holding that § 314(d) bars review of PTAB decisions under § 315(b).

    The majority voiced policy concerns that if a patent owner was allowed to appeal Board determinations under § 315(b), such appeals would "tug against that objective [providing an efficient mechanism for weeding out "bad patents," a term that is usually a signal on the philosophical leanings of the Court], wasting the resources spent resolving patentability and leaving bad patents enforceable."  The Court foresaw that a patent owner would appeal on § 315(b) untimeliness grounds "only if she could not prevail on patentability, [and consequently] §315(b) appeals would operate to save bad patent claims."  The Court also noted that its decision was consistent with the statutory scheme, which "so consistently elevat[es] resolution of patentability above a petitioner's compliance with §315(b)" because the Board's adjudication on the merits is thereby preserved.

    The opinion further notes that, if Congress had wished to limit the extent of § 314(d) as patent owner and the dissent contend, it could have easily drafted the legislation to recite that the appellate review bar of § 314(d) be limited to Board determinations under § 314(a).

    The opinion is also consistent with earlier decisions by the Court interpreting the statutory regime of inter partes review, including Cuozzo and SAS Institute Inc. v. Iancu.  These decisions taken together strongly suggest that if Congress wants an administrative agency to have authority that cannot be challenged by a reviewing Court it needs to expressly grant that unreviewability status to the agency by statute.  As a consequence of these decisions, the only challenge that may be available to a frank disregard of the § 315(b) time limit by the Board would be to raise such a challenge on due process grounds, an option that the Court left open explicitly in Oil States Energy Serv. LLC v. Greene's Energy Group LLC.

    The dissent by Justice Gorsuch provides a different interpretation of the statute and would limit the scope of the § 314(d) reviewability bar to the institution decision and not bar any other provisions of the statute relating to inter partes review.  In the views of the dissenting Justices:

    Today the Court takes a flawed premise—that the Constitution permits a politically guided agency to revoke an inventor's property right in an issued patent—and bends it further, allowing the agency's decision to stand immune from judicial review.  Worse, the Court closes the courthouse not in a case where the patent owner is merely unhappy with the merits of the agency's decision but where the owner claims the agency's proceedings were unlawful from the start.  Most remarkably, the Court denies judicial review even though the government now concedes that the patent owner is right and this entire exercise in property-taking-by-bureaucracy was forbidden by law.

    The dissent expresses a worry the majority's decision puts patentees as property holders at bureaucratic mercy without recourse to courts.  "No matter how wrong or even purposefully evasive, the Director's assessment of a petition's timeliness is always immune from review" is the consequence of the majority decision, according to the dissent, and even without any ill intention ("[t]he Board can err") such errors are beyond the scope of judicial review (at least with regard to any issue involving institution decisions).

    The dissent finds in the statutory language little textual support for the majority's construction, for example, there being nothing in § 315(b) regarding a determination by the Director such as is found in § 314.  "To pretend otherwise would invite a linguistic nonsense" and "practical nonsense as well" according to Justice Gorsuch.

    The dissent also reminds the majority (and us) that there is a presumption of judicial review that serves an important purpose under our law.  Relying on The Federalist No. 48, the dissent reminds us what the Founders considered to be important about separation of powers and checks and balances between the three branches and the particular importance of the judiciary in giving citizens a remedy when aggrieved by decisions from the other branches.  The Justices opine that it would be surprising "to think Congress might have imposed an express limit on an executive bureaucracy's authority to decide the rights of individuals, and then entrusted that agency with the sole power to enforce the limits of its own authority."  The Justices are less concerned about (or convinced that) Congress's intent in establishing inter partes review proceedings to be an efficient way of ferreting out "bad patents."  In their view, there is ample evidence that "Congress also included provisions to preserve the value of patents and protect the rights of patent owners."

    Justice Gorsuch writes alone in the final section of the dissent, where he reiterates his view that the majority's decision "takes us further down the road of handing over judicial powers involving the disposition of individual rights to executive agency officials" which he believes began with the Court's decision in Oil States (a decision from which he also dissented).  The Justice analogizes the consequences of that decision, (where the Court determined the patent right to be a public franchise and not a property right) to land grants.  For those rights, "[n]o one thinks we would allow a bureaucracy in Washington to 'cancel' a citizen's right to his farm," and plainly the Justice doesn't think the bureaucracy that is the Patent Office should be doing so for patents, citing Hovey v. Henry, 12 F. Cas. 603, 604 (No. 6,742) (CC Mass. 1846), in support of patent rights being property rights akin to land grants.  And the Justice is also concerned that:

    The abdication of our judicial duty comes with a price.  The Director of the Patent and Trademark Office is a political appointee.  The AIA vests him with unreviewable authority to institute (or not) inter partes review.  Nothing would prevent him, it seems, from insulating his favorite firms and industries from this process entirely.  Those who are not so fortunate proceed to an administrative "trial" before a panel of agency employees that the Director also has the means to control.  The AIA gives the Director the power to select which employees, and how many of them, will hear any particular inter partes challenge.  It also gives him the power to decide how much they are paid. And if a panel reaches a result he doesn't like, the Director claims he may order rehearing before a new panel, of any size, and including even himself.

    And moreover:

    No one can doubt that this regime favors those with political clout, the powerful and the popular. But what about those who lack the resources or means to influence and maybe even capture a politically guided agency?  Consider Mr. DuVal, who 25 years ago, came up with something the Patent Office agreed was novel and useful.  His patent survived not only that initial review but a subsequent administrative ex parte review, a lawsuit, and the initiation of another.  Yet, now, after the patent has expired, it is challenged in still another administrative proceeding and retroactively expunged by an agency that has, by its own admission, acted unlawfully.  That is what happens when power is not balanced against power and executive action goes unchecked by judicial review. Rather than securing incentives to invent, the regime creates incentives to curry favor with officials in Washington.

    And perhaps foreshadowing the issues the Court will grapple with in future, the Justice notes that Article III courts have abdicated their authority to the PTAB as an Article I court in cases like XY, LLC v. Trans Ova Genetics, L.C. and Fresenius USA, Inc. v. Baxter Int'l, Inc.

    The dissent concludes:

    Two years ago, this Court sanctioned a departure from the constitutional plan, one in which the Executive Branch assumed responsibilities long reserved to the Judiciary.  In so doing, we denied inventors the right to have their claims tried before independent judges and juries.  Today we compound that error, not only requiring patent owners to try their disputes before employees of a political branch, but limiting their ability to obtain judicial review when those same employees fail or refuse to comply with the law.  Nothing in the statue commands this result, and nothing in the Constitution permits it.

    The concerns expressed in the dissent are consistent with Justice Gorsuch's dissent in Oil States; what may be more interesting is Justice Sotomayor joining in expressing these concerns (although the Justice did not join the part of the dissenting opinion where these concerns were most strongly raised).

    Thryv, Inc. v. Click-to-Call Technologies, LP (2020)
    Opinion by Justice Ginsberg, joined by Chief Justice Roberts and Justices Breyer, Kagan, and Kavanaugh, joined by Justices Thomas and Alito except for Part III–C; dissenting opinion by Justice Gorsuch, joined by Justice Sotomayor as to parts I, II, III, and IV

  • Cardionet, LLC v. Infobionic, Inc. (Fed. Cir. 2020)

    By Kevin E. Noonan —

    Federal Circuit SealThere are (at least) two ways of looking at the course of the Federal Circuit's evolving interpretation of the Supreme Court's subject matter eligibility jurisprudence under Mayo Collaborative Services v. Prometheus Labs., Inc. and Alice Corp. v. CLS Bank Int'l.  One way is to consider the Court to be adrift, unable to come to a consensus on how the law should be interpreted and thus calling into question the wisdom of Congress's decision to establish a court with purportedly specialized expertise in patent law (see, e.g., "In Defense of the Federal Circuit").  Alternatively, the exercise can be analogized to sausage-making (more usually an analogy used for how legislation is crafted), in recognition that the Supreme Court's Mayo/Alice jurisprudence, while enunciated as a two-part test has been, in the practice, much less straightforward in application.  The understanding and interpretation of either analysis is influenced anew with every Federal Circuit decision, and the Court's recent decision in Cardionet, LLC v. Infobionic, Inc. illustrates anew the internal divisions, where one judge (Judge Dyk) agreed with the outcome but felt compelled to write in partial dissent on one aspect of the majority's reasoning.

    The case arose in litigation between the parties over cardiac monitoring technology protected under U.S. Patent No. 7,941,207.  The Court considered claims 1, 2, 3, 7, 10-12, and 22 to be relevant:

    1.  A device, comprising:
        a beat detector to identify a beat-to-beat timing of cardiac activity;
        a ventricular beat detector to identify ventricular beats in the cardiac activity;
        variability determination logic to determine a variability in the beat-to-beat timing of a collection of beats;
        relevance determination logic to identify a relevance of the variability in the beat-to-beat timing to at least one of atrial fibrillation and atrial flutter; and
        an event generator to generate an event when the variability in the beat-to-beat timing is identified as relevant to the at least one of atrial fibrillation
        and atrial flutter in light of the variability in the beat-to-beat timing caused by ventricular beats identified by the ventricular beat detector.

    2.  The device of claim 1, wherein the relevance determination logic is to accommodate variability in the beat-to-beat timing caused by ventricular beats by weighting ventricular beats as being negatively indicative of the one of atrial fibrillation and atrial flutter.

    3.  The device of claim 1, wherein the variability determination logic is to compare times between R-waves in three successive QRS complexes to determine the variability in the beat-to-beat timing.

    7.  The device of claim 1, wherein the event generator is to generate an event by performing operations comprising: collecting data associated with the collection of beats; and transmitting the data associated with the collection of beats to a remote receiver.

    10.  The device of claim 1, wherein the relevance determination logic comprises logic to identify the relevance of the variability using a non-linear function of a beat-to-beat interval.

    11.  The device of claim 1, wherein the beat detector comprises a QRS detector.

    12.  The device of claim 1, further comprising a sensor that includes two or more body surface electrodes subject to one or more potential differences related to cardiac activity.

    22.  An article comprising one or more machine-readable media storing instructions operable to cause one or more machines to perform operations, the operations comprising: determining a beat-to-beat variability in cardiac electrical activity; determining a relevance of the variability over a collection of beats to one of atrial fibrillation and atrial flutter using a non-linear function of a beat-to-beat interval; and identifying one of an atrial fibrillation event and an atrial flutter event based on the determined relevance, the event being a period in time when the information content of the cardiac electrical activity is of increased relevance to the one of atrial fibrillation and atrial flutter [wherein] determining the relevance comprises: identifying a beat of the collection as a ventricular beat, and weighting the beat as being negatively indicative of the one of atrial fibrillation and atrial flutter.

    (where the claim language in italics is recited in independent claim 20 from which claim 22 depends).  The opinion also illustrated the invention with a reproduction of Figure 10*:

    ImageAs the opinion sets forth, the invention permits a clinician to distinguish atrial fibrillation and atrial flutter from other forms of cardiac arrhythmias with regard to "beat-to-beat variability in heart rate over a series of successive heartbeats."  Importantly, the invention achieves its objectives "by analyzing the beat-to-beat timing for atrial fibrillation or atrial flutter while also taking into account the variability in the beat-to-beat timing caused by premature ventricular beats."  As a consequence, "the device can more accurately distinguish atrial fibrillation and atrial flutter from other types of arrythmias and has 'improved positive predictability of atrial fibrillation and atrial flutter," resulting (as set forth in the specification) in "a sensitivity to [these two arrhythmias] in excess of 90% and a positive predictivity in excess of 96%."

    CardioNet asserted claims 1, 2, 3, 7, 10-12, and 22 against Infobionic.  The District Court dismissed CardioNet's complaint under Fed. R. Civ. Proc. 12(b)(6), on the ground that the claims were ineligible for patenting under 35 U.S.C. § 101 as interpreted under the Supreme Court's Mayo/Alice test. The District Court determined that, under step 1 of the test the claims were directed to an abstract idea, that these arrhythmias "can be distinguished by focusing on the variability of the irregular heartbeat."  And under step 2 of the test, the District Court held that "CardioNet 'd[id] not identify improvements to any particular computerized technology'" related to detecting electrical signals relevant to cardiac function.  This appeal followed.

    The Federal Circuit reversed and remanded, in an opinion by Judge Stoll joined in full by Judge Plager and in part by Judge Dyk, who dissented over the terminal portion of the opinion as set forth in further detail below.  The opinion does not start promisingly, citing Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 749 (Fed. Cir. 2019), for the standard of review (de novo, with factual issues construed in favor of the non-moving party).  After setting forth the details of the Mayo/Alice test, as well as citing Federal Circuit precedent on how that jurisprudence has been applied, the opinion turned to its assessment of how this jurisprudence should be applied to the claims before it.

    The panel renders its decision on step 1, holding that the claims are not merely directed to an abstract idea.  According to the opinion (which is unanimous on this point), the claims are directed to an improvement in cardiac monitoring technology.  The opinion states:

    [T]he language of claim 1 indicates that it is directed to a device that detects beat-to-beat timing of cardiac activity, detects premature ventricular beats, and determines the relevance of the beat-to-beat timing to atrial fibrillation or atrial flutter, taking into account the variability in the beat-to-beat timing caused by premature ventricular beats identified by the device's ventricular beat detector.

    In the Court's view, the claims "focus" on specific methods for improving this technology, and are not directed to an abstract idea itself or ones that "merely invoke generic processes and machinery."  These conclusions, the opinion maintains, are supported by the written description, the opinion citing portions of the specification directed to "multiple technological improvements" (citations to the specification omitted):

    First and foremost, the device more accurately detects the occurrence of atrial fibrillation and atrial flutter—as distinct from [ventricular tachycardia] V-TACH and other arrhythmias—and allows for more reliable and immediate treatment of these two medical conditions.  . . .  Indeed, the written description reports that when analyzing real-world arrhythmia data, the device demonstrated both high "positive predictivity" of, and high "sensitivity" to, atrial fibrillation and atrial flutter, meaning that it effectively avoids false positives and false negatives, respectively, in detecting these two conditions.  In addition, the device is able to identify sustained episodes of atrial fibrillation and atrial flutter that have "increased clinical significance."

    (The opinion recites additional aspects of the invention in support of its conclusion recited in dependent claims.)

    The opinion cites Federal Circuit precedent consistent with its opinion here, including Visual Memory LLC v. NVIDIA Corp. for the proposition that improvements to computer processing (in Visual Memory, computer memory) could be patent-eligible.  The opinion notes that it was "important to our determination" in favor of patent eligibility in Visual Memory that the specification set forth "advantages offered by" the claimed invention (supplying a seemingly bright-line practice tip to patent prosecutors, at least for now).  The panel found the same type of "advantages" recited in the '207 specification, with the same result regarding patent-eligibility.  The Court found similar support, based on similar analogies, in McRO, Inc. v. Bandai Namco Games Am. Inc. and support for the principle that "patent's written description[ can] inform[] our understanding of the claims" in Chamberlain Grp., Inc. v. Techtronic Indus. Co.

    The panel found the District Court's error in "the incorrect assumption that the claims are directed to automating known techniques" (as InfoBionic argued below and maintained in its arguments to the Federal Circuit).  But "nothing in the record" supports this view nor the fact-finding by the District Court, according to the opinion.  The lower court also erred, in the Federal Circuit's view, in its consideration of the disclosure in the '207 patent specification, where it disregarded CardioNet's attempts to point out the relevant differences between the invention and the prior art.  Part of this error was also procedural, because in considering a motion to dismiss, the District Court was obliged to "construe all facts and draw all reasonable inferences in favor of CardioNet, the non-moving party," which the District Court did not do here.  Finally, the Federal Circuit disagreed that the facts and issues before the court were comparable to the facts and legal determinations in Berkheimer v. HP Inc. and FairWarning IP, LLC v. Iatric Systems, Inc., relied upon by the District Court.

    The opinion then turns to a discussion of the question of whether the Court can decide patent eligibility or must remand to the District Court for factual assessments as to the state of the art and whether the claims are directed merely to automating practices long used by physicians (it is here that Judge Dyk parts company with his brethren).  The panel majority held that step 1 of the Mayo/Alice test is directed to the question of "whether the claims as a whole are 'directed to' an abstract idea, regardless of whether the prior art demonstrates that the idea or other aspects of the claim are known, unknown, conventional, unconventional, routine, or not routine," citing Diamond v. Diehr, 450 U.S. 175, 188–89 (1981) (a holding that puts Diehr and Mayo in direct opposition should the Supreme Court deign to decide the distinctions between the panel majority and Judge Dyk).  The majority opinion then distinguishes the purpose of Section 101 with the other provisions of the patent statute, sub silentio restoring the analysis to the state of the law pre-Mayo.  While acknowledging Judge Dyk's appreciation of statements in both Mayo and Bilski v. Kappos suggesting that the state of the prior art may be relevant, the majority notes that "in neither Bilski nor Alice did the Court rely on an examination of the prior art as part of its step one inquiry."  Instead, the majority cites the intrinsic evidence as the proper source of information for a court to arrive at the answer to step 1 of the Mayo/Alice test for determining patent eligibility.  For the majority, "[t]his court's decision in Enfish, LLC v. Microsoft Corp. . . . confirms this point":  "the Alice step one inquiry in Enfish and our other decisions began, and ended, with the patent itself," according to the majority.  To the extent that there is evidence that the claims recite "longstanding practice where there is no evidence of such practice in the intrinsic record," the majority believes a district court can take judicial notice thereof in appropriate circumstances.  For the majority the question, and its answer, is clear:

    Thus, we simply clarify that step one of the Alice frame-work does not require an evaluation of the prior art or facts outside of the intrinsic record regarding the state of the art at the time of the invention.  Neither Bilski, Alice, nor this court's precedent endorses such an analysis.  [O]ur analysis at Alice step one involves examining the patent claims in view of the plain claim language, statements in the written description, and the prosecution history, if relevant.  . . .  The analysis does not require a review of the prior art or facts outside of the intrinsic record regarding the state of the art at the time of the invention.

    Judge Dyk disagreed.  The Judge rejects the majority's contention that its decision is consistent with Supreme Court and Federal Circuit precedent, and disparages it as mere dicta, not being a basis for the Court's holding here (the dissent cites to the defendant's admission that there were no factual disputes to be resolved on remand).  For this Circuit Judge, the majority's error is "limiting the use of extrinsic evidence to establish that a practice is longstanding," a position that the dissent notes was not taken by either party.  Judge Dyk cites Bilski and Alice specifically for the principle that the Court considered extrinsic evidence concerning the conventionality of claimed methods in determining that claims in these cases were ineligible for being directed to an abstract idea.  The Judge also cites Federal Circuit precedent, including Intellectual Ventures I LLC v. Erie Indem. Co., Affinity Labs of Texas, LLC v. DIRECTV, LLC, 838 F.3d 1253 (Fed. Cir. 2016), Content Extraction & Transmission LLC v. Wells Fargo Bank, Berkheimer, and cases cited by the majority (BASCOM, FairWarning) in support of this position.  In Judge Dyk's view, the Federal Circuit "[has] persistently looked outside the intrinsic evidence" in deciding issues under step 1 of the Mayo/Alice test.  And the Judge finds no authority to support its conclusion that a district court is limited to intrinsic evidence in deciding the question of whether a claim is directed to an abstract ides under step 1 of the Supreme Court's Mayo/Alice test.

    Cardionet, LLC v. Infobionic, Inc. (Fed. Cir. 2020)
    Panel: Circuit Judges Dyk, Plager, and Stoll
    Opinion by Circuit Judge Stoll; opinion dissenting in part and concurring in the result by Circuit Judge Dyk

    * The opinion also contains an explication of some of the technical terms used in the claims; readers are directed to those explanations, which are outside the scope of this post.

  • Conference & CLE Calendar

    CalendarApril 21, 2020 – "Dosage Patents in the UK, Europe and Beyond" (J A Kemp) – 15:30 to 16:30 pm GMT

    April 21, 2020 – "International Patent Cooperation Initiatives" (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

    April 23, 2020 – "Inequitable Conduct: A Refresher and Update" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    April 23, 2020 – "Patent Management: Uncovering Cost-Savings in your Portfolio" (LexisNexis® and IPWatchdog) – 12:00 pm (EDT)

    April 23, 2020 – "Recent PTAB Developments" (Federal Circuit Bar Association) – 3:00 pm to 4:00 pm (EST)

    April 23, 2020 – "Linking an Invention to the Evidence: Strategic Considerations from Prosecution to Litigation" (Fitch Even) – 12:00 pm to 1:00 pm (ET)

    April 28, 2020 – "Gender Diversity in Innovation Toolkit — Virtual Roadshow" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

  • IPO Webinar on Gender Diversity in Innovation Toolkit

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Gender Diversity in Innovation Toolkit — Virtual Roadshow" on April 28, 2020, from 2:00 to 3:00 pm (ET).  Sandra Nowak of 3M Company; Molly Kocialski, Director of the Rocky Mountain Regional Office, U.S. Patent and Trademark Office; Karen Maples of FutureForward; and Andrew Toole, Chief Economist, U.S. Patent and Trademark Office will discuss the USPTO's Progress and Potential Report and gender diversity statistics, the USPTO's new diversity in innovation toolkit, the IPO's Gender Diversity in Innovation Toolkit, and the AUTM University and Tech Transfer Toolkit.  The panel will also examine these various perspectives and discuss how you can use these tools to positively impact the diversity in innovation culture within your organization.

    There is no registration fee for this webinar, and pre-registration is not required.  Those interested in attending the webinar, should click here.

  • USPTO Patent Quality Chat Webinar Series

    USPTO SealThe U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series from 12:00 to 1:00 pm (ET) on April 21, 2020.  The latest webinar, entitled "International Patent Cooperation Initiatives," will address how the USPTO is engaged in a variety of worksharing programs and initiatives that bring multiple-office examination efforts together to improve patent examination quality and timeliness while reducing stakeholder costs, including the new Parallel Patent Grant (PPG) program with Mexico, the Collaborative Search Pilot Program (CSP), and Global Dossier.

    Additional information regarding this webinar, including instructions for viewing the webinar via Livestream, can be found here.

  • IPO Webinar on Inequitable Conduct

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Inequitable Conduct: A Refresher and Update" on April 23, 2020, from 2:00 to 3:00 pm (ET).  William Covey, Deputy General Counsel and Director of the Office of Enrollment and Discipline for the U.S. patent and Trademark Office; David Hricik, Mercer University School of Law; and Warren Woessner of Schwegman Lundberg & Woessner will review the USPTO rules regarding inequitable conduct; discuss important decisions regarding inequitable conduct since Therasense, Inc. v. Becton, Dickinson & Co., including Regeneron, Gilead and GS CleanTech; and address the conflicting pressures patent prosecutors face from the USPTO and clients.

    The registration fee for the webinar is $135 (IPO member) or $150 (non-member) (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • Webinar on Patent Management Portfolio

    LexisNexisLexisNexis® and IPWatchdog will be offering a webinar on "Patent Management: Uncovering Cost-Savings in your Portfolio" on April 23, 2020 at 12:00 pm (EDT).  Gene Quinn of IPWatchdog.com and Williams Mansfield of LexisNexis® will discuss how to:

    • calculate the overall annuity fees for your patent portfolio,
    • quickly analyze your's or your competitors’ renewal fees,
    • view annuity fees per year and/or per country,
    • combine annuity fees with other PatentSight indicators, e.g., the Patent Asset Index™, to improve your decision on pruning candidates by analyzing the costs for low quality patents, and
    • forecast budget requirements for each year to maintain annuity fees for all patents.

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

  • FCBA Webcast on Recent PTAB Developments

    Federal Circuit Bar Association_2The Federal Circuit Bar Association (FCBA) will be offering a webcast entitled "Recent PTAB Developments" on April 23, 2020 from 3:00 pm to 4:00 pm (EST).  Christopher Geyer of Appian Corporation will moderate a panel consisting of David Cavanaugh of WilmerHale, Sharonmoyee Goswami of Cravath, Swaine & Moore LLP, and Jonathan Stroud of Unified Patents, Inc.  The panel will address the following topics:

    • Arthrex and what we have learned regarding remands
    • Pointers for remote oral arguments at the PTAB
    • Hulu and its impact

    The webinar is complimentary for FCBA members and students, $50 for government, academic, or retired practitioners, or $175 for private practitioners.  Those interested in registering for the webcast, can do so here.

  • Webinar on Strategic Considerations from Prosecution to Litigation

    Fitch EvenFitch Even will be offering a webinar entitled "Linking an Invention to the Evidence: Strategic Considerations from Prosecution to Litigation" on April 23, 2020 from 12:00 pm to 1:00 pm (ET).  Mark A. Borsos and Evan Kline-Wedeen of Fitch Even will discuss the following:

    • Establishing a nexus between evidence of commercial success of real-world products and the patented invention
    • Demonstrating a connection between patented features and lost profits
    • Proving there is a causal nexus between irreparable harm and the patented invention that justifies an injunction
    • Drafting claims with forethought to future evidentiary requirements

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