• MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Navigating USPTO Pilot Programs" on March 11, 2020 from 10:00 am to 11:15 am (CT).  In this presentation, MBHB attorneys Lawrence Aaronson and Brett Scott will present a survey of various USPTO pilot programs, some less known than others, but all useful in the right circumstances, and discuss the ins and outs of each program and present some practical prosecution tips and insights.  Pilot programs that will be covered in the webinar include:

    • First Action Interview Pilot Program
    • After Final Consider Pilot Program 2.0
    • Pre-Appeal Brief Request and Conference Pilot Program
    • Expedited Patent Appeal Pilot Program
    • Quick Path IDS Pilot Program
    • Ombudsman Pilot Program
    • Motions to Amend Pilot Program (AIA)
    • Trademark Post-Registration Audit Pilot Program

    The webinar will also briefly touch on other USPTO pilot programs, including some more rare programs and some discontinued programs.

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

  • Federal Circuit Bar Association_2The Federal Circuit Bar Association (FCBA) will be offering a CLE program on "Enhancing Diversity & Inclusion in IP Law and Beyond" on March 5, 2020 from 3:00 pm to 5:30 pm (ET) at The Army and Navy Club in Washington, DC.  The program will include two panels:  a Pipeline Panel will explore how a focus on inclusion can develop the next generation of legal leaders, and a Partnership Panel will delve into how legal departments and law firms can partner to enhance diversity in the profession.

    The registration fee for the program is $100 (BPLA members), $300 (non-members), or free (judges).  Additional information regarding the program, including an agenda and list of panelists, can be found here.

  • 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 February 19, 2020.  The latest webinar, entitled "Application readiness: Assessing incoming applications," will address how the USPTO is studying the shared responsibility of patent examination quality in the area of incoming applications.

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

  • IPO #2The Intellectual Property Owners Association (IPO) will offer two one-hour webinars on February 20 and 26, 2020.  In the first webinar, entitled "Blocking Patents in Litigation after Acorda: What's Acorda's Impact Inside and Outside of Pharma?" which will be held on February 20, 2020 from 2:00 to 3:00 pm (ET), Elaine Blais of Goodwin Procter, David Manspeizer of Squire Patton Boggs, and Frank Nuzzi of Siemens will analyze whether the Federal Circuit's decision in Acorda v. Roxane is a game changer in Hatch-Waxman litigation; whether the lesser role of secondary considerations will relegate Acorda to the sidelines in high tech patent litigation; and how the fact-specific inquiry required by Acorda will likely play out with discovery, expert testimony, and questions about the burden of proof.  In the second webinar, entitled "Blocking Patents in Prosecution Strategy and Corporate IP Strategy after Acorda," which will be held on February 26, 2020 from 2:00 to 3:00 pm (ET), Adriana Burgy of Finnegan, Stephen Durant of Schwegman Lundberg & Woessner, and Jeffrey Hohenshell of Medtronic will discuss what prosecution strategies will best protect such inventions if they are now more vulnerable, and whether such considerations should now impact corporate IP strategy and budgets.

    The registration fee for each webinar is $135 (government and academic rates are available upon request).  Those interested in registering for either webinar can do so here and here.

  • Claims Directed to Capture and Output of Digital Content Held Patent Ineligible

    By James Korenchan

    District Court for the District of DelawareA few weeks ago, the U.S. District Court for the District of Delaware granted Defendants' Rule 12 motions in three different cases, each naming Pebble Tide LLC (hereinafter, "Pebble") as Plaintiff.  The Defendants in the three cases were Arlo Technologies, Inc., Uniden America Corp., and Petcube, Inc.  In granting the Rule 12 motions, the Court found the claims of two asserted patents — U.S. Patent Nos. 10,261,739 (the '739 patent) and 10,303,411 (the '411 patent) — to be invalid as being patent ineligible under 35 U.S.C. § 101.

    The asserted patents were in the same family and generally related to client-server interactions for capturing and outputting digital content, most notably in the context of printing.  The invention includes a system having an "information apparatus" (e.g., a smartphone having a digital camera, or another computing device that can capture digital content), a server, and a client device (e.g., a computing device for accessing digital content).  The patents state that the invention addresses a need in the art for users to be able to easily output information from information apparatuses to printers or other devices that output content, without having to depend on synchronizing with "stationary" computers such as desktop computers.  The invention also aims to output information to such devices without having to find and install device-dependent or other specific types of drivers, and without losing the original quality of captured content.  More particularly, the patents specifically note that, with the invention, "[u]nlike conventional output or printing, a user does not have to manually pre-install a device driver (e.g., printer driver) from a CD, floppy disk, or download the driver somewhere from a network," which "is well-suited for providing output capability to small and lower-cost mobile devices with limited memory space, power supply and processing capability to still be able to output or print to an output device."  The patents also note that with the invention, "hardware and software installation for static or permanent network connectivity may not be necessary for the output device."

    The parties agreed that claim 1 of the '739 patent is representative of the two patents.  It recites:

    1.  A system for outputting output data, comprising:
        an information apparatus that includes a digital capturing device for capturing digital content, at least one wireless communication module for wireless communication, and at least one processor, the at least one processor directs the at least one wireless communication module to:
            establish a wireless communication connection with one or more servers over a network that includes the Internet, the one or more servers being distinct devices from the information apparatus;
            transmit, over the wireless communication connection, a device object that includes device information related to the information apparatus, from the information apparatus to the one or more servers; and
            provide, over the wireless communication connection, the digital content captured by the digital capturing device of the information apparatus, from the information apparatus to the one or more servers;
        server software executable at the one or more servers, the one or more servers include at least a network communication interface for network communication, and the one or more servers include memory for storing at least part of the digital content received from the information apparatus;
        client software executable at a client device, the client device is a distinct device from the information apparatus and from the one or more servers, wherein the client device includes:
            one or more wireless communication units for wireless communication,
            an output device for outputting output data; and
            one or more processors for executing at least part of the client software, wherein the client software provides, via the one or more wireless communication units of the client device, one or more job objects to the one or more servers over the network, the one or more job objects including at least one of security information or identification information for accessing the one or more servers, and the one or more job objects further include subscription information for accessing the one or more servers;
        wherein the server software further:
            receives, via the at least one network communication interface, the digital content from the information apparatus;
            stores, in the memory of the one or more servers, at least part of the received digital content;
            generates, at the one or more servers, output data for output at the client device, the output data is related to at least part of the digital content received by the one or more servers from the information apparatus, and the generating of the output data is related, at least partly, to at least a portion of the device object received by the one or more servers from the information apparatus; and
            provides, via the at least one network communication interface of the one or more servers, at least part of the output data, from the one or more servers to the client device, for outputting at least part of the digital content received from the information apparatus, the providing of at least part of the output data is subsequent to the one or more servers having received the one or more job objects from the client software at the client device; and
        wherein the client software further:
            receives, via the one or more wireless communication units of the client device, at least part of the output data from the one or more servers, and the receiving of the at least part of the output data is subsequent to the client device having provided the one or more job objects to the one or more servers over the network; and
            outputs at least part of the output data, received at the client device, at the output device associated with the client device.

    If you read this claim and found it to be a long-winded way of describing the storage, generation, and transmission of data, you aren't alone.

    In Alice Corp. v. CLS Bank Int'l, the Supreme Court set forth a two-part test for determining whether a claim is directed to patent-eligible subject matter under § 101.  First, it must be determined whether the claim involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, it must be determined whether the claim recites an inventive concept — that is, an element or combination of elements that is sufficient to ensure that the claim is significantly more than the judicial exclusion.  But generic computer implementation of an otherwise abstract process does not qualify as significantly more, nor does an element or combination of elements that is well-understood, routine, and conventional.

    In applying the first part of the Alice test, the Court deemed claim 1 to be directed to an abstract idea of "wirelessly outputting data from one device to another," citing Cellspin Soft, Inc. v. Fitbit, Inc. ("we have consistently held that similar claims reciting the collection, transfer and publishing of data are directed to an abstract idea") in support of this conclusion.  The Court also reached this conclusion based on the similarities between this claim and those held by the Federal Circuit to be abstract in ChargePoint, Inc. v. SemaConnect, Inc. ("abstract claims directed to transmitting data from one device to another").  The Court also found the claim to be lacking technical details, stating that both the claims and the patents' specification merely describe the recited components in functional terms.

    Turning to second part of the Alice test, the Court shot down a variety of seemingly scattered attempts at Pebble arguing that the claims recite an inventive concept, even after considering some constructions that Pebble more-recently proposed.  For instance, the Court briefly dismissed Pebble's notions that the "information apparatus" (which the specification states "generally refer[s] to computing devices") or the interplay of the job object process and the device object process is inventive.

    The main focus of the Court's discussion on part two was on whether the ordered combination of the conventional computer components and processes is an inventive concept.  Pebble unsuccessfully tried to analogize the combination of elements recited in claim 1 to the claims in Cellspin, which involved steps for acquiring and transferring data from a data capture device to a mobile device.  In response, the Court noted that:

    [T]he claims use merely functional language and that nothing in the claims or the specification details how this purported combination achieved the touted results of solving the problem of widespread incompatibility between wireless devices and corresponding output devices.

    Pebble was also unsuccessful in trying to analogize claim 1 to BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC.  In BASCOM, the Federal Circuit found the plaintiff's ordered combination of claim elements to be inventive after the plaintiff had demonstrated that its claims recited a specific, discrete implementation of an abstract idea and that the patent itself describes how the claimed arrangement of elements is a technical improvement over the prior art.  By contrast, the Court here believed Pebble was not able to make such a demonstration:

    When I asked Pebble Tide's counsel to identify where the asserted patents or complaints concretely describe a specific method that was unconventional, he was unable to do so….  In my view, this case is closer to the Two-Way Media decision of the Federal Circuit in 2017 where that Court held or found that a particular ordered combination of asserted limitations did not reveal an inventive concept because unlike in BASCOM, there, the claim used a conventional ordering of steps with conventional technology to achieve its desired results.

    Thus, the Court found the claims of the asserted patents to be patent ineligible under § 101.  This case exemplifies patent-eligibly battles over lengthy claims that, despite their length, are supported by meager technical details and descriptions of improvements to computer technology.

    Pebble Tide LLC v. Arlo Technologies, Inc. (D. Del. 2020)
    Memorandum Order by District Judge Stark

  • By Kevin E. Noonan

    District Court for the District of DelawareEver since the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories was handed down in 2012, diagnostic method claims have been routinely invalidated by the district courts and those decisions upheld by the Federal Circuit.  Indeed, in her recent dissent of the Court's denial of patentee's petition for rehearing en banc in Athena Diagnostics v. Mayo Collaborative Services, Judge Newman enumerated the six (now, seven including Athena) Federal Circuit decisions holding diagnostic method claims to be patent ineligible under Section 101.  In her dissent in Athena, Judge O'Malley noted that:

    Since Mayo, every diagnostic claim to come before this court has been held ineligible.  While we believe that such claims should be eligible for patent protection, the majority of this court has definitively concluded that the Supreme Court prevents us from so holding.  No need to waste resources with additional en banc requests.  Your only hope lies with the Supreme Court or Congress.  I hope that they recognize the importance of these technologies, the benefits to society, and the market incentives for American business.  And, oh yes, that the statute clearly permits the eligibility of such inventions and that no judicially-created exception should have such a vast embrace.  It is neither a good idea, nor warranted by the statute.  I dissent.

    A bleak prospect, to say the least.

    But as Justice Breyer mentioned in Mayo, the Supreme Court's eligibility precedent has cautioned "against interpreting patent statutes in ways that make patent eligibility "depend simply on the draftsman's art" without reference to the "principles un­derlying the prohibition against patents for [natural laws]" citing Parker v. Flook, 437 U. S. 584, 593 (1978).  And yet, experience has shown time and again that adapting to the Court's shifting precedents requires competent draftsmen to use their experience and skill as draftsmen to capture for inventors claims to provide protection against expropriation by infringers.  See, e.g., Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals.

    The latest example of creative drafting (including how the invention was described in the specification) is a recent decision (Report and Recommendation [to the District Court judge]), by Magistrate Judge Christopher J. Burke in the District of Delaware, who denied defendant's Rule 12(b)(6) motion (of ineligibility) in CareDX, Inc. v. Natera, Inc.  The case arose over the claims in U.S. Patent Application Nos. 8,703,652 and 9,845,497, directed to "methods to help predict the status or outcomes of transplant recipients through sequencing of cell-free nucleic acids ("cfDNA") found in the bodily fluids of a recipient." The rationale behind the invention is rejection of a transplanted organ in a recipient is accompanied by cell death, which releases donor-specific DNA into the recipient's bodily fluids.  Claim 1 of the '652 patent and claim 1 of the '497 patents are representative:

    The '652 patent claim 1:

    1.  A method for detecting transplant rejection, graft dysfunction, or organ failure, the method comprising:
        (a) providing a sample comprising cell-free nucleic acids from a subject who has received a transplant from a donor;
        (b) obtaining a genotype of donor-specific polymorphisms or a genotype of subject-specific polymorphisms, or obtaining both a genotype of donor-specific polymorphisms and subject-specific polymorphisms, to establish a polymorphism profile for detecting donor cell-free nucleic acids, wherein at least one single nucleotide polymorphism (SNP) is homozygous for the subject if the genotype comprises subject-specific polymorphisms comprising SNPs;
        (c) multiplex sequencing of the cell-free nucleic acids in the sample followed by analysis of the sequencing results using the polymorphism profile to detect donor cell-free nucleic acids and subject cell-free nucleic acids; and
        (d) diagnosing, predicting, or monitoring a transplant status or outcome of the subject who has received the transplant by determining a quantity of the donor cell-free nucleic acids based on the detection of the donor cell-free nucleic acids and subject cell-free nucleic acids by the multiplexed sequencing,
        wherein an increase in the quantity of the donor cell-free nucleic acids over time is indicative of transplant rejection, graft dysfunction or organ failure, and wherein sensitivity of the method is greater than 56% compared to sensitivity of current surveillance methods for cardiac allograft vasculopathy (CAV).

    The '497 patent claim 1:

    1.  A method of detecting donor-specific circulating cell-free nucleic acids in a solid organ transplant recipient, the method comprising:
        (a) genotyping a solid organ transplant donor to obtain a single nucleotide polymorphism (SNP) profile of the solid organ transplant donor;
        (b) genotyping a solid organ transplant recipient to obtain a SNP profile of the solid organ transplant recipient, wherein the solid organ transplant recipient is selected from the group consisting of: a kidney transplant, a heart transplant, a liver transplant, a pancreas transplant, a lung transplant, a skin transplant, and any combination thereof;
        (c) obtaining a biological sample from the solid organ transplant recipient after the solid organ transplant recipient has received the solid organ transplant from the solid organ transplant donor, wherein the biological sample is selected from the group consisting of blood, serum and plasma, and wherein the biological sample comprises circulating cell-free nucleic acids from the solid organ transplant; and
        (d) determining an amount of donor-specific circulating cell-free nucleic acids from the solid organ transplant in the biological sample by detecting a homozygous or a heterozygous SNP within the donor-specific circulating cell-free nucleic acids from the solid organ transplant in at least one assay,
        wherein the at least one assay comprises high-throughput sequencing or digital polymerase chain reaction (dPCR), and
        wherein the at least one assay detects the donor-specific circulating cell-free nucleic acids from the solid organ transplant when the donor-specific circulating cell-free nucleic acids make up at least 0.03% of the total circulating cell-free nucleic acids in the biological sample.

    The Magistrate Judge resolved the issue of whether these claims were ineligible for patenting under 35 U.S.C. § 101 under the first step of the Supreme Court's test enunciated in Mayo and Alice Corp. v. CLS Bank Int'lDefendants argued (as they must) that the claims in the patents-in-suit were directed to one of the judicial exceptions (a natural phenomenon, specifically "the correlation between transplant rejection and the presence of naturally occurring [cfDNA] in the bodily fluids of transplant recipients").  The Magistrate, relying on Federal Circuit precedent permitting a court to consider the patent specification in determining "what a patent claim is really directed to at step one [of the Mayo/Alice test]" (Enfish LLC v. Microsoft Corp.) found that:

    "[T]he patents' [related] specification repeatedly and consistently states that this basic 'correlation' between the presence of increased levels of donor-specific cfDNA and transplant rejection . . . – i.e., the thing that, according to Defendants, the asserted claims were purportedly 'directed to' – had already been well-known in the art for quite a long time.

    The Magistrate's findings further explicated disclosure in the specification related to prior art efforts to use distinguishing markers from donor DNA (Y chromosome sequences from male donors in female recipient, or HLA antigens that differed between donors and recipients) and how those efforts had failed.

    The Magistrate then raised this rhetorical question:  "How could it be the case that the 'basic thrust or 'character as a whole' or 'focus' of the purportedly representative claims of the patents is to a naturally-occurring correlation, when the patentee repeatedly states that this very correlation was already well-known in the art?  To ask the question is to answer it," according to the Magistrate, further stating "[i]t does not, in fact, make a lot of sense to think that the claims are directed to something the patent repeatedly says the claims are not directed to."  Relying further on the specification, the Magistrate credits the patentee for "tell[ing] us that what it thinks was really invented here . . . is something other than the correlation itself":

    [T]he invention provides a universal approach to noninvasive detection of graft rejection in transplant patients which circumvents the potential problems of microchimerism from DNA from other foreign sources and is general for all organ recipients without consideration of gender.  In some embodiments, a genetic fingerprint is generated for the donor organ.  This approach allows for a reliable identification of sequences arising solely from the organ transplantation that can be made in a manner that is independent of the genders of donor and recipient.

    The Magistrate concludes from his analysis that "what the inventors were focused on here was how to develop a new, more accurate and useful analytic method of determining whether significant amounts of cfDNA were present in a transplant recipient's body(so that one could then make use of the known correlation between that fact and indication of transplant rejection)" (emphasis in Report).

    The Magistrate does not rely solely on these distinctions, however.  The Report goes on to identify the language in the claims reciting detection methods that are not "routine, conventional, and well-understood":  specifically, digital PC/high-throughout sequencing/ multiplex sequencing methods.  (In footnote 8, the Magistrate states that "the key point here for purposes of Alice's step one is that the claims appear to be 'directed to' these particular methods for detecting – and not to the fact or existence of the natural phenomenon itself" (emphasis in Report)).

    Accordingly, the Magistrate concludes that Defendants failed to meet their burden and recommends that the District Court judge deny the motion; tellingly, the Magistrate cites the Federal Circuit's Rapid Litig. Mgmt. Ltd. v CellzDirect Inc. decision in supporting the distinctions he relied upon here in making his Recommendation.

    As refreshing as this opinion is, the reality is that it is a Report and Recommendation and thus one that the District Court judge may not follow (and Defendants are sure to make a case that the Judge should not follow it).  The Magistrate Judge's description of how the draftsman disclosed the invention is reminiscent of the philosophy employed by judo practitioners, who use an opponent's mass and momentum to gain an advantage.  By acknowledging the conventionality of the natural phenomenon underlying the invention, the issue of what the claims were "directed to" under the Mayo/Alice analytical framework could be decided in their favor.  This is important, because the test is to be applied sequentially:  if a defendant cannot satisfy the first, "directed to" prong, a court should not have the occasion to address the second prong relating to whether the recited detection method(s) were "routine, conventional, and well-understood."  This approach also has the benefit of "grasping the nettle" of the tendency to blend other, prior art-related sections of the patent statute, thereby vitiating their effectiveness of blurring the statutory distinctions into a rhetorical mess.  It cannot be said that this approach is a universal one, but it illustrates the wisdom of never acquiescing to the current state of patent eligibility jurisprudence so long as artful drafting (specification and claims) can permit a patentee to prevail.

    CareDX, Inc. v. Natera, Inc. (D. Del. 2020)
    Report and Recommendation by Magistrate Judge Burke

  • By Kevin E. Noonan

    University of California-BerkleyOn January 9th, Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") filed a Motion in Opposition to Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") Substantive Motion No. 3 in support of the Patent Trial and Appeal Board ("Board") de-designating certain claims as not corresponding to Count 1 in Interference No. 106,155 as declared.

    To recap, in its Motion No. 3, the Broad reiterated the arguments made in Motion No. 2, that there are two embodiments of CRISPR, one involving single-molecule RNA guide RNA that corresponds to Count 1 (which the Broad argues here is not recited in the claims it wants the Board to designate as not corresponding to the Count) and further that certain of the Broad's claims directed to "SaCas9" systems that require two or more nuclear localization signals (NLSs) do not correspond to the Count.  The Broad parsed the Broad's claims into three categories of claims that do not correspond to the Count, depending on how the Board rules on Substantive Motions Nos. 1 and 2:

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

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

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

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

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

    The Broad argued with regard to the first category of these claims (comprising the majority of the claims the Broad wants to have de-designated) that the Count of the interference as declared is directed to "single-molecule guide RNA molecule" embodiments of CRISPR that do not encompass these single-molecule guide RNA embodiments and thus do not corresponding to the Count.  The brief sets forth the Broad's understanding that, should the Board deny the Broad's Substantive Motions Nos. 1 and 2, then the interference will involve priority to such single-molecule guide RNA embodiments as a separate, patentable invention over claims that encompass both single-molecule and dual molecule embodiments (termed "generic guide" embodiments in the brief).  The Broad argues that its claims limited to dual-molecule embodiments do not correspond to the Count and the Board should so designate.

    The Broad asserts as reasons/justifications for de-designating certain (most) of its claims:

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

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

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

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

    CVC's argument centers on proper application of Rule 207(b)(2):

    A claim corresponds to a count if the subject matter of the count, treated as prior art to the claim, would have anticipated or rendered obvious the subject matter of the claim.  37 C.F.R. §41.207(b)(2).

    This is the standard, and CVC argues first that on this basis the Board should deny the Broad's motion, and moreover that the Broad had not satisfied its burden that it is entitled to the relief requested under 37 C.F.R. §§ 41.121(b) and 41.208(b).  And the Broad will not be able to meet this burden, CVC argues, because a claim to a species (single-molecule guide RNA CRISPR embodiments) anticipates a claim to a genus (generic-guide RNA CRISPR embodiments), citing In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989).

    CVC further parses the language of the Rule to distinguish that this section does not set forth a (rebuttable) presumption despite the title of this rule being "Presumptions."  CVC draws a parallel with Rule 207(a), wherein subsection (1) sets forth the presumptions and subsection (2) sets forth the standard (for priority in subsection (a) and for claim correspondence in subsection (b)); the brief recited several citations to case law to support this interpretation, including Yorkey v. Diab, 601 F.3d 1279, 1286-87 (Fed. Cir. 2010), citing Bosies v. Benedict, 27 F.3d 539, 541 (Fed. Cir. 1994); and Brown v. Barbacid, 276 F.3d 1327, 1333 (Fed. Cir. 2002).  In addition, the brief asserts that a plain text reading of Rule 207(b)(2) is enough and controlling with regard to the Board's decision, citing Octane Fitness LLC v. ICOM Health & Fitness, Inc., 572 U.S. 545, 553 (2014), and the Standing Order Para. 208.3.2.  The brief also counters the Broad's arguments regarding comments made during rulemaking, that such comments cannot override the text of the rule, citing two Executive Orders from the Trump Administration (E.O. 13891, Promoting the Rule of Law through Improved Agency Guidance Documents, 84 Fed. Ref. 55235 (Oct. 15, 2019) and 13892, Promoting the Rule of Law through Transparency and Fairness in Civil Administrative Enforcement and Adjudication, 84 Fed. Reg. 55239 (Oct. 15, 2019)).

    CVC counters the Broad's arguments that the Board should grant its Motion No. 3 because Count 1 does not correspond to its "best proofs" because, inter alia, the Broad hasn't offered any evidence that it has better proofs that it would be able to offer under Count 1.  CVC also asserts that the Broad assumes, without proving or even arguing, that the generic-guide claims are patentably distinct over single-molecule guide embodiments of CRISPR.  In addition, CVC argues that the Broad's assertion of this argument is inconsistent with the Broad's argument in its Substantive Motion No. 2 that claims to single-molecule guide embodiments of CRISPR are not patentably distinct over generic-guide embodiments.  "Broad cannot have it both ways," says CVC with regards to these allegedly inconsistent arguments.  Further, with regard to the Broad's "best proofs" argument, CVC contends that it is fair to have all the Broad's claims stand or fall in this interference because the Broad has not established its "best proofs" argument and it has the burden to do so to be entitled to the relief of de-designating the claims.

    Turning to the Broad's expert testimony, CVC asserts that the Board cannot, and should not rely on the Broad's experts because these experts did not review documentary evidence supporting the Broad's assertions that the Broad inventors practiced generic-guide RNA CRISPR in 2011 (prior to CVC's earliest priority date), as the Broad alleges in its motion.  There are also contradictions, according to CVC, between what the expert testified is disclosed in an NIH grant proposal in this interference and what the Broad declared before the USPTO during ex parte prosecution of USSN 14/704,551 regarding this document.  The declarations submitted during prosecution were the basis for the Examiner to determine that the Broad could antedate CVC's earlier single-molecule guide RNA disclosures and thus were patentable over them.  And CVC contends that the Board should consider these declarations in ex parte prosecutions to be admissions.  The brief also argues that judicial estoppel precludes the Broad from relying on the purportedly contradictory expert testimony, citing Zedner v. U.S. and setting forth how circumstances in this interference satisfy the Supreme Court's Zedner test.  Specifically, estoppel should lie when a party's legal position is "clearly inconsistent with" a prior position; the party prevailed based on its prior position; and the opposing party (here, CVC) would be clearly disadvantaged, imposing an unfair detriment against them, by permitting a party to take a position in this proceeding contrary to its position in the earlier proceeding.  All those factors align in CVC's favor, according to their brief, under circumstances regarding the position the Broad has taken with regard to this brief in this interference and the contrary position taken by Senior Party during ex parte prosecution.

    These circumstances also seem to put the Broad's experts in a bad position because they were not given access to information that might have reduced or eliminated their ability to make the representations they did in their testimony in this interference, including ones showing that Broad inventors had not been able to practice CRISPR in eukaryotic cells in the June 2012 timeframe.

    CVC notes (in a "sauce for the goose" manner) that should the Board determine that the Broad's generic-guide claims be de-designated, then CVC's generic guide claims should be de-designated as well, requiring the Board to provide another interference count or declare another interference.  However, the presumption is that the PTAB properly designated the claims corresponding to the count and the burden is on a party requesting de-designation relief to establish they are entitled to such relief.  Much of these issues depend on claim construction, and according to CVC the term "guide RNA" did not have a plain and ordinary meaning but was dependent on definitions in the Broad's specification(s) that don't support Broad's construction.  Furthermore, the Broad's arguments in this regard should fail, according to CVC's brief, because all the claims recite "chimeric" RNA which comprise single-molecule embodiments, citing definitions in the specifications of the Broad's patents and applications in interference.

    With regard to the Broad's arguments concerning S. aureus Cas9 claims and claims reciting multiple nuclear localization signal (NLS), that the Broad argues should be de-designated as not corresponding to Count 1, CVC makes its case that these proteins were known in the art and their smaller size and capacity to be introduced using adeno-associated virus (AAV) vectors would have motivated a person of ordinary skill in the art (POSA) to use them for eukaryotic CRISPR and further that there would be a reasonable expectation of success in doing so.  CVC also makes a detailed case with regard to why the Sa Cas9 species are not patentably distinct, and makes similar arguments regarding CRISPR embodiments comprising multiple NLS species.

    Finally, throughout the brief CVC reiterates the theme that the Broad's motions are all attempts to avoid having the Board determine priority of eukaryotic cell embodiments of CRISPR.

  • By Kevin E. Noonan

    Federal Circuit SealExpert witness testimony is a frequent (almost ubiquitous) feature of patent litigation, if only because questions of the state of the art or the understanding of one having ordinary skill in the art are almost always at issue for claim construction, infringement, and invalidity issues.  In HVLPO2, LLC v. Oxygen Frog, LLC, the Federal Circuit addressed whether opinion testimony from a witness not qualified as an expert is admissible, deciding that it is not.

    The case arose in patent infringement litigation over U.S. Patent Nos. 8,876,941 and 9,372,488, directed to "methods and devices for controlling an oxygen-generating system, which is used to sustain and manage airflow for torch glass artists who use surface mix glass torches."  Claim 1 of the '488 patent is representative:

    1.  An apparatus for managing an oxygen generating system, the oxygen generating system configured for supplying a sustained flow of a gaseous mixture comprising mostly oxygen, the apparatus comprising: a controller device configured to: receive a first pressure signal associated with a first pressure; determine the first pressure to be less than or equal to a startup threshold pressure, said first pressure associated with a gaseous pressure of an oil-less tank; send a signal to switch a first circuit on, said first circuit for providing electrical power to a bank of at least two oxygen generators; send a signal to switch a second circuit on, said second circuit for providing electrical power to an oil-less air compressor; receive a second pressure signal associated with a second pressure; determine the second pressure to be greater than or equal to a shutoff threshold pressure, said second pressure associated with a gaseous pressure of the oil-less tank; send a signal to switch the first circuit off; and send a signal to switch the second circuit off.

    The District Court granted summary judgment to HVLPO2 on infringement and had a jury trial on Oxygen Frog's assertions that the claims were obvious.  The jury considered testimony from a lay witness, who was deposed as a fact witness and was not qualified as an expert, who testified that the invention would have been obvious to him based on the prior art (which consisted in part of an on-line video that the witness posted himself).  HVLPO2 objected to this testimony as expert witness testimony by a lay witness, but the District Court permitted the jury to consider the evidence over the objection, giving instead a limiting instruction ("a witness such as [the witness] certainly can offer his observations and explain to you how a system works and what he thinks would occur to him from his perspective would or would not be obvious").  The jury found the claims to be obvious, the District Court denied HVLPO2's motion for a new trial, and this appeal followed.

    The Federal Circuit reversed, in an opinion by Judge Moore, joined by Judges Newman and Chen.  The panel held that the District Court's denial of HVLPO2's motion for a new trial was an abuse of discretion (under 11th Circuit law), on the grounds that it was error to permit the jury to hear the lay witness's testimony and rely on that testimony to find the claims in suit obvious.  "Under the circumstances here," according to the opinion, "that determination was plainly wrong; the district court's limiting instruction was insufficient to cure the substantial prejudice caused by [the lay witness's] testimony."

    The opinion cites Federal Rule of Evidence 702 in support of its decision, regarding the qualifications required to establish a witness as an expert, finding that this standard "precisely describes testimony which would pertain to an obviousness invalidity challenge in a patent trial."  An expert's role is to assist the fact finder "to understand the evidence  or to determine a fact at issue," citing Sundance, Inc. v. DeMonte Fabricating Ltd, 550 F.3d 1356, 1361-62 (Fed. Cir. 2008) (which considered the prohibition against expert testimony in an obviousness determination).

    The opinion also cites Federal Rule of Civil Procedure 26, which requires that a party disclose an expert witness to an opposing party and provide a written expert report containing "all opinions of the expert, the reasons and bases for those opinions, and all facts relied upon in the formation of the opinion."  Fed. R. Civ. P. 26(a)(2).  Here, Oxygen Frog did not comply with these requirements, but argued on appeal that the requirements did not apply because its witness was not proffered as an expert.  The Federal Circuit disagreed, saying that this testimony "was directed to the central legal HVO's asserted patent claims were invalid for obviousness."

    The panel rejected Oxygen Frog's argument that permitting the jury to consider the lay witness's testimony was mere harmless error.  The panel held that this was an error that caused "substantial prejudice" because it was the basis for the jury returning a verdict that the claims at issue were obvious.  And the panel considered this prejudice in context:

    There is no way to know whether [the lay witness's] improper testimony provided some or all of the basis for the jury's decision.  Not only did the district court's admission of [the lay witness's] improper testimony deprive HVO of its right to have the question of obviousness decided based on admissible, qualified expert testimony, it prejudiced HVO by not affording it the appropriate procedures for testing such testimony.

    In addition, the panel notes that expert testimony is subject to challenge under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).  And the opinion notes HVLPO2 was not afforded the procedural protections of the Federal Rules by the District Court's admission of expert testimony by a lay witness, which worked "significant[] prejudice" to HVLPO2.

    Finally, while acknowledging that in some circumstances a district court can cure improper admission of  inadmissible testimony, in this case the panel found that the instruction was no cure because it "improperly permit the jury to consider [the lay witness's] testimony as evidence of obviousness" and was "no different than an instruction for how a jury should consider expert testimony" (emphasis in opinion).

    HVLPO2, LLC v. Oxygen Frog, LLC (Fed. Cir. 2020)
    Panel: Circuit Judges Newman, Moore, and Chen
    Opinion by Circuit Judge Moore

  • CalendarFebruary 12, 2020 – "Global Patent Trends in Biologics Innovation" (Derwent) – 11:00 am (EST)

    February 13, 2020 – "Litigating Civil and Criminal Trade Secret Cases: Trends, Best Practices, and Lessons Learned" (Practising Law Institute) – 1:00 to 2:00 pm (EST)

    February 18, 2020 – "Patent Eligibility and Section 101 Update" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

  • DerwentDerwent will be offering a webinar on "Global Patent Trends in Biologics Innovation" on February 12, 2020 starting at 11:00 am (EST).  Rose Hughes of AstraZeneca and Caroline Peel of Clarivate Analytics will discuss the trends shaping the biosequence technology landscape and also give attendees a preview into what these trends mean for the industry at large.  The panel discussion will include an analysis of global patent activity as a predictor for biologics growth, a breakdown of the top organizations leading biotechnology and biopharma innovation, and other topics, including the following:

    • Leading technology areas in biosequence patents
    • Acquiring Innovation: building versus buying
    • Biotechnology hot spots around the globe

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