• Fitch EvenFitch Even will be offering a webinar entitled "Latest Developments in the Patentability of AI- and Software-Based Inventions" on September 24, 2020 from 12:00 pm to 1:00 pm (ET).  Thomas F. Lebens and Zachary Van Engen of Fitch Even will provide an update on the latest legal developments in computer software patentability along with guidance on best practices for protecting software-related innovations, covering the following topics:

    • Ramifications of recent post-AliceFederal Circuit cases
    • Updated USPTO guidelines
    • Tips for patent application drafting
    • Tips for responding to office actions

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

  • By Donald Zuhn

    USPTO SealIn a notice published in the Federal Register (85 Fed. Reg. 58038) earlier today, the U.S. Patent and Trademark Office announced that it was implementing a deferred-fee provisional patent application pilot program in order to promote the expedited exchange of information about inventions designed to combat COVID–19.  In the notice, the Office states that it recognizes that its charge to issue high-quality patents to inventors goes hand-in-hand with the dissemination of important technical information, and that the free-flow of such information is now more important than ever in view of the urgent challenges posed by COVID–19.

    Applicants who participate in the pilot program will be allowed to defer payment of the provisional application filing fee (which is currently $280 for large entities) until the filing of a nonprovisional application claiming the benefit of the provisional application in exchange for permitting the Office to make the technical subject matter disclosed in the provisional application available to the public via a searchable collaboration database maintained on the Office's website.  In order to qualify for participation in the pilot program, the subject matter disclosed in the provisional application must concern a product or process related to COVID–19, and such product or process must be subject to approval by the U.S. Food and Drug Administration (FDA) for COVID-19 use.  According to the notice, a provisional application qualifies for participation in the pilot program if such FDA approval "has been obtained, is pending, or will be sought prior to marketing the subject matter for COVID–19."  The notice indicates that such approvals include an Investigational New Drug (IND) application, an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologics License Application (BLA), a Premarket Approval (PMA), or an Emergency Use Authorization (EUA).  The notice also indicates that the subject requirement for participation in the deferred-fee provisional patent application pilot program is the same as that for participation in the COVID–19 prioritized examination pilot program, which was announced in May (see "USPTO Announces COVID-19 Prioritized Examination Pilot Program").

    The requirements to participate in the pilot program are as follows:

    1.  Applicants must submit a certification and request for participation in the program using form PTO/SB/452.

    2.  The submission must be in the English language.

    3.  The submission must include a provisional application cover sheet pursuant to 37 C.F.R. § 1.51(c)(1) (or an Application Data Sheet, which may serve as the provisional application cover sheet).

    4.  The submission (i.e., provisional application specification, including any drawings, claims, and/or abstract, provisional application cover sheet (or ADS), and form PTO/SB/452) must be filed electronically via the Office's Patent Center, and the specification must be filed in DOCX format to facilitate making the text searchable.

    5.  The submission must meet the requirements for a provisional application under 35 U.S.C. § 111(b)(1) and 37 C.F.R. § 1.53(c), except for the payment of the basic filing fee, which would be deferred under the pilot program.

    The notice indicates that a submission that does not include a legible specification in DOCX format will be handled as a provisional application and not a pilot program submission.  However, if a submission does not include a provisional application cover sheet or application size fee (if the latter is required), the Office will give Applicants an extendable two-month time period to submit the missing items.

    The technical subject matter of provisional applications accepted to the pilot program will be uploaded by the Office into a searchable public collaborative database, and the submission will be processed as a provisional application.  The notice states that the database will also publish the name of the inventor or the first named joint inventor, the provisional application filing date, and the date the submission was placed in the database, but will not publish the provisional application cover sheet.

    The notice explains that while a provisional application filing fee is a statutory requirement under 35 U.S.C. § 111(b)(3), the Director is authorized under that same section to allow Applicants to pay that fee after the filing date of the application.  However, the notice also explains that the basic filing fee under 37 C.F.R. § 1.16(d) must be paid by the Applicant in order to rely on the provisional application in a later-filed nonprovisional application.  Participants in the pilot program will receive a reminder from the Office 10 months after the provisional application filing date indicating that the basic filing fee must be paid not later than 12 months after the provisional application filing date in order to claim the benefit of the filing date of the provisional application in a nonprovisional application.

    In a section of the notice entitled "Prior Art Considerations," the Office states that "[a]n inventor's technical disclosure published in the collaboration database cannot be used against the inventor's own corresponding later-filed nonprovisional application in the United States, provided that the later-filed application is filed within one year of the public disclosure."  However, the notice also states that:

    Special care should be taken where foreign patent protection is desired.  Many foreign jurisdictions treat an inventor's public disclosure made within one year of filing as prior art against the inventor's own application unless that earlier disclosure is the subject of a proper priority claim in that jurisdiction.  For this reason, applicants should be aware of the prior art implications of their submissions.

    Making a submission under the program will result in a public disclosure of the technical subject matter via the Office's searchable collaboration database.  Thus, such a public disclosure may be citable as prior art under 35 U.S.C. 102(a)(1) as of the date it publishes.  In addition, the complete provisional patent application submitted under the program may become prior art under 35 U.S.C. 102(a)(2) as of the filing date, but only if there has been a proper benefit claim under 35 U.S.C. 119(e) in a later-filed nonprovisional application or international application and the later-filed application has been published or deemed published under 35 U.S.C. 122(b) or has issued as a U.S. patent.

    The notice also explains that "[t]here is no provision for withdrawal from the program," and that "[o]nce the technical subject matter of a program submission is made available to the public in the searchable collaboration database on the USPTO's website, that public availability cannot be revoked."

    The Office began accepting certifications and requests for participation in the pilot program today and will accept requests for the next 12 months, at which time the program may be extended or terminated by the Office.  The notice also indicates that depending on feedback and interest in the pilot program, the technological scope may be expanded beyond COVID–19 to other areas that are the focus of pioneering or rapid innovation.  Provisional applications filed prior to September 17, 2020 are not eligible for participation in the pilot program.

    The Office will accept public comments regarding the pilot program, but such comments must be received by November 16, 2020 to be considered by the Office.  Comments should be sent by e-mail and addressed to Covid19ProvisionalApplication@uspto.gov.

  • By Kevin E. Noonan

    Anopheles_albimanus_mosquitoThere are an estimated 219 million cases of malaria per year, leading to more than 400,000 deaths annually according to the World Health Organization.  Hemocytes (insect white blood cells) comprise the mosquito immune system and are the basis for immunity to malaria.  There are three known hemocyte types:  granulocytes (highly phagocytic cells of about 10 to 20 μm in diameter); oenocytoids (8- to 12-μm round cells that produce melanin involved in pathogen encapsulation); and prohemocytes (round cells (4 to 6 μm) with a high nuclear-to-cytoplasmic ratio and are thought to be precursors of the other two cell types).  These can be circulating in the hemolymph or resident in tissues like the gut epithelium (where the ookinete stage of the Plasmodium migrates).  Upon infection, hemocytes activate and kill Plasmodium parasite by complement activation.  Repeated infection is prevented by immunological memory termed "priming" in mosquitos; subsequent infections stimulate release of hemocyte differentiation factor into the hemolymph, which causes granulocyte induction.  This priming is effectuated by release of hemocyte differentiation factor (HDF), a combination of lipoxin 4 and evokin, which is a lipocalin carrier.

    Against this backdrop of basic mosquito biology, an international team* of researchers reported their results of an in-depth study of mosquito immune system in a paper published in Science entitled "Mosquito cellular immunity at single cell resolution."  Using single cell RNA sequencing techniques on individual hemocytes, these researchers analyzed transcriptomes from 5,383 Anopheles gambiae specimens, comparing transcriptomes of circulating hemocytes from mature adult female mosquitos fed either a sugar meal or with a blood meal from Plasmodium-infected or healthy mice.  Their results showed the following major cell clusters:  two from adipose tissue, one from muscle tissue, and six hemocyte clusters.  One adipose-tissue derived cluster expressed several immune-modulatory genes such as CAP-Gly domain containing linker proteins (CLIPs, including CLIPA1, -7, -8, -9, and -14), homeobox transcription factors LRIM1, -4A, -8A, -8B, -9, and -17, lectins (CTL4 and MA2), and Serpin 2 (SRPN2).  The other adipose-tissue derived cluster expressed high levels of vitellogenin, a canonical fat-body marker.  The six hemocyte clusters had diverse characteristics:

    • HC1 showed high mRNAs levels of prophenoloxidases, including PPO4 and PPO9, characteristic of oenocytoids, and contained low levels of leucine-repeat protein 8 (LRR8) mRNA.

    • HC2 showed low or absent PPO4 and high LLR8 levels; had a morphology typical of prohemocytes and granulocytes; expressed SPARC, cathepsin-L, and LRR8; had 73% fewer unique molecular identifiers (UMIs) (mean UMI of 413) than cells of the HC3 cluster; and were less differentiated and were thought to constitute prohemocytes.

    • HC3 showed low or absent PPO4 and high LLR8 levels; had a morphology typical of prohemocytes and granulocytes; expressed SPARC, cathepsin-L, and LRR8; had a greater number of UMI than cells of the HC2 (mean of 1516); and typical granulocyte morphology, with prominent pseudopodia and abundant granules.

    • HC4 showed low or absent PPO4 and high LLR8 levels; had a morphology typical of prohemocytes and granulocytes; shared markers with cells of the HC3 cluster; expressed cyclin B, aurora kinase, and other mitotic markers, which suggests that they are proliferating hemocytes — consistent with this hypothesis, cells in this cluster expressed mitotic markers consistent with proliferation in response to a blood meal which was also consistent with blood-feeding induced DNA synthesis; and a correlation analysis shows these cells to be granulocytes.

    • HC5 showed low levels of LLR8 and expressed no PPO4; expressed high levels of an uncharacterized transmembrane protein AGAP007318 (TM7318) and lipopolysaccharide-induced tumor necrosis factor–α transcription factor 3 (LL3); and showed two different morphologies, wherein TM7318-positive cells were present in low abundance (0.5% of granulocytes) that represented a novel, separate giant cell type (25 to 40 μm) they termed "megacytes".

    • HC6 showed low levels of LLR8 and no PPO4, were negative to HC4 and HC5 markers but expressed antimicrobial peptides such as defensin 1, cecropins 1, and C-type lysozyme; and also exhibited differential morphologies, whereas cells negative for TM7318 represented small granulocytes that expressed antimicrobial genes (AM Gran) (16.4% of granulocytes).

    The transcriptomes were further analyzed and these researchers found that granulocytes formed three major subclusters, one representing the basal state (Gran1) and the others represented by cells activated by blood meal (Gran2) and Plasmodium infection (Gran3).  Prohemocytes, on the other hand, clustered into two population subclusters (PHem1 and PHem2), wherein PHem2 seems to be an intermediate between PHem1 and Gran1.  The Gran1 cluster was linked to Gran2 and Gran3, with Gran3 being linked to dividing granulocytes.  Gran2 also linked to megacytes, and Gran1 linked to antimicrobial granulocytes, as shown in the accompanying figure:

    Fig 2DThe status of immunological cells in An. gambiae was compared with another insect vector species, Aedes aegypti, known to transmit dengue fever, yellow fever, chikungunya, and Zika virus.  When compared with transcriptomes of An. gambiae, cross-species correlation analysis revealed four different cell states, including a proliferating S-phase granulocyte cluster (AaHC6) without a clear An. gambiae equivalent. These researchers appreciated two clusters (AaHC1 and AaHC2) with conserved transcriptome signatures for oenocytoids (99 and 77% correlation, respectively, with AgHC1) and different granulocyte types, including antimicrobial peptide–expressing cells (94% with AgHC6) and proliferating granulocytes (87% with AgHC4).  Granulocytes expressed laminins, leucine-rich repeat proteins, scavenger receptors, Toll-like receptor 5, and the transcription factor Rel2.  However, megacytes (AgHC5) detected in An. gambiae lacked an obvious counterpart in Aedes, and their characteristic marker (TM7318) was present only in anophelines of the Cellia subgenus (unlike Aedes, these mosquitos are malaria vectors in Africa and Asia).

    The researchers summarized their results by saying:

    Together, these analyses suggest the existence of a proliferative, oligopotent cell population that can replenish the pool of granulocytes and differentiate into more specialized hemocytes, such as megacytes and antimicrobial granulocytes.

    And further:

    The conservation of diverse and molecularly well-defined hemocyte types between distantly related mosquito genera and the apparent absence of megacytes in our Ae. aegypti mosquito dataset raise questions as to how the immune systems of these mosquito species have evolved to limit their capacity to transmit parasites and arboviruses to humans.  This knowledge will ultimately underpin immunological strategies aimed at interrupting disease transmission by rendering mosquitoes resistant to such pathogens.

    * Wellcome Sanger Institute, Cambridge; Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health USA; Zoology Department, Stockholm University; Departamento de Biología del Neurodesarrollo, Instituto de Investigaciones Biológicas Clemente Estable, Montevideo; Institute and Department of Physics, University of Cambridge; Molecular Infection Medicine Sweden, Molecular Biology Department, Umeå University

  • By Circuit Judge Paul R. Michel (Ret.) and John T. Battaglia —

    The esteemed authors of Patent Docs have written of the need to reconsider the Federal Circuit's approach to section 101 eligibility, given the court's latest expansion and en-banc vote on subject-matter eligibility in AAM v. Neapco (Fed. Cir. July 31, 2020).  Is It Time for Federal Circuit to Rethink Its Subject Matter Eligibility Jurisprudence? by Kevin E. Noonan, Ph.D., Patent Docs (Aug. 24, 2020).  Among other points, we agree that such a need exists and suggest that the first step should lie with correcting the Federal Circuit's decisions in Enfish and Affinity Labs—the precedents that set forth the Federal Circuit's interpretation of "directed to" in the Mayo-Alice "framework" for testing a patent claim's ineligibility.  See Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1334-35 (Fed. Cir. May 12, 2016); Affinity Labs of Texas, LLC v. DirecTV, LLC, 838 F.3d 1253, 1257-58 (Fed. Cir. Sept. 23, 2016); 35 U.S.C. §101.

    To be sure, Enfish was (and largely remains) one of the rare Federal Circuit precedents that upheld the claims' eligibility.  But we are not concerned with particular outcomes; only legal reasoning and an even-handed rule of law.  And Enfish's analysis and resulting rule of law on §101 does not track even the Supreme Court's Mayo-Alice §101 framework, itself fraught with controversy.  More specifically, Mayo-Alice established the two-step "framework" to assess patent-eligibility:  step one asks whether the claim-at-issue "is directed to" an ineligible topic, such as an abstract idea or natural law; and if so, step two asks whether the claim's elements nevertheless add "something more" and demonstrate an "inventive concept" over what was "routine, conventional, or well-understood" at the time.  Alice Corp. Pty Ltd. v. CLS Bank Int'l, 134 S.Ct. 2347, 2355 (2014); Mayo Collaborative Servs v. Prometheus Labs, Inc., 132 S.Ct. 1289, 1298 (2012) (all emphases added unless otherwise noted).

    Enfish in particular interpreted Alice's "directed to" language, as used in step one.  With that backdrop, we analyze Enfish's transformation of what was once a one-step eligibility test into a framework that, at both steps of Mayo-Alice, delves into the claim's patentability or "patentable advances."

    I.  The Enfish Focus: What Does "Directed to" in Alice Step One Mean?

    In Enfish, the Federal Circuit applied the Mayo-Alice ineligibility framework to a patent claiming an improved "self-referential database" design for computers.  822 F.3d at 1333.  Microsoft had successfully challenged these claims as "abstract," persuading the district court to grant summary judgment of ineligibility.  Id. at 1330.  The Federal Circuit panel agreed these claims were sufficiently similar to claims deemed "abstract" in other precedents.  Id. at 1334-35.  But then it turned to the issue that resulted in the Federal Circuit's unique §101 rule:  Namely, the issue of interpreting Alice's step one "directed to" language.

        A.  Enfish Misinterprets "Directed to."

    Enfish started well enough.  It rejected the notion that "directed to" meant "involved," since such a broad interpretation would sweep in and put at risk myriad patent claims.  822 F.3d at 1335 ("That formulation plainly contemplates that the first step of the inquiry is a meaningful one, i.e., that a substantial class of claims are not directed to a patent-ineligible concept.  The 'directed to' inquiry, therefore, cannot simply ask whether the claims involve a patent-ineligible concept, because essentially every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon") (citation omitted) (emphasis in original).

    But then Enfish ceased any effort to deconstruct "directed to."  It didn't consider, for example, its own case law, the decisions for which have been using "directed to" for decades before Alice issued.  Nor did it consider how the Supreme Court's pre-Mayo-Alice precedents had applied the eligibility exceptions for §101.  If Enfish had, it would've fairly discerned that "directed to" and variations thereof meant the claim-at-issue was "in practical effect on" or "essentially" on an ineligible topic "itself"—such as the "formula itself" for computing an "updated alarm limit," Parker v. Flook, 437 U.S. 584, 587 (1978), or an "algorithm itself," Gottschalk v. Benson, 409 U.S. 63, 67-72 (1972); accord Diamond v. Diehr, 450 U.S. 175, 182 (1981).  The Supreme Court specifically re-affirmed these precedents in its 2012 Mayo opinion.  132 S.Ct. at 1298, 1302.

        B.  Enfish Relies on Dicta in Alice Step Two to Define the Different Test in Step One.

    Enfish took a different approach when interpreting step-one's "directed to" formulation.  Primarily, it latched onto a sentence of dicta at the tail-end of Alice.  In Enfish's reading, this Alice dicta "suggested that claims 'purport[ing] to improve the functioning of the computer itself,' or 'improv[ing] an existing technological process' might not succumb" to the abstract idea exception in step one.  822 F.3d at 1335 (citing "see" Alice, 134 S.Ct. at 2358-59).  Enfish admitted, however, that it was taking this "improved computer" dicta from the Alice Court's discussion on step two (the "inventive-concept" step) in order to define step one (the "directed to" ineligibility step).  Id.  But Enfish had a reason: "While it is true that the Court discussed improvements to computer-related technology in the second step of its analysis in Alice, …, that was because the Court did not need to discuss the first step of its analysis at any considerable length, …."  Id.

        C.  The Bottom Line: How Enfish Changed Alice Step One into a Test That Examines the Claim's     "Patentable Advance" Over the Prior Art.

    In sum, the Federal Circuit in Enfish took the following to answer what "directed to" means in Alice's step-one eligibility framework:  (1) a sentence of Alice dicta; (2) on a specific technology ("improvements in computer technology"); and (3) that Alice addressed only when discussing step two's "inventive-concept" test.  Based on those points, Enfish effectively extended Alice to conclude that this step-two dictum was now (1) binding; (2) on all technologies subject to a §101-ineligibility challenge; and (3) applicable to Alice's step-one "directed-to" test.  In doing all this, Enfish transformed Alice step one from a test that asked "whether the claims at issue are directed to" a patent-ineligible concept to the "inquiry [that] … look[s] at the 'focus of the claimed advance over the prior art' to determine if the claim's 'character as a whole' is directed to excluded subject matter."  Affinity Labs, 838 F.3d at 1257-58; accord Enfish, 822 F.3d at 1327, 1335; American Axle & Manufacturing LLC v. Neapco Holdings, –F.3d–, No. 18-1763, at *9 (Fed. Cir. July 31, 2020) (applying Enfish-Affinity Labs' "patentable advance" inquiry to claimed process for manufacturing auto-parts).

    II.  Enfish Couldn't Justify Its Step-One "Directed-to" Interpretation By Relying on Alice "Computer" Dicta in Step-Two's "Inventive Concept" Test.

    In our view, Enfish cannot reasonably rely on Alice step-two dicta—dicta focused on a specific technology, no less—to fashion what has become the Federal Circuit's across-the-board step-one test.  Dicta is of course non-binding.  And the terse Alice sentence on "computer" technology hardly seems like a sufficient foundation on which to substantially transform the Federal Circuit's step-one inquiry, applicable in all circumstances.

    These factors alone should've counseled against Enfish's approach.  Arguably as well, so too should have the differences between Alice's two steps, with one step focused on "ineligibility," the other on an "inventive-concept" test "analogous" to patentability.  Contrast, e.g., SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 1167 (Fed. Cir. 2018) (addressing ineligibility of claimed calculation under Alice and explaining that, no matter how "new" or even ingenious that claimed mathematical calculation might be, it was "still an [ineligible] abstract idea") (emphasis in original) with Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1346-48 (Fed. Cir. 2015) (explaining how step two's "inventive-concept" search requires an analysis "analogous to those of § 102 [anticipation] and §103 [obviousness]" and comparing claims to "the prior art").

    Moreover, the lone justification Enfish offered for such cross-step borrowing—its belief that Alice simply "didn't need to discuss the first step of its analysis at any considerable length"—seems to rest on speculation.  As we read it, the proper deduction is that Alice didn't discuss this "patentable advance" test (or anything similar) in its step-one eligibility analysis precisely because the Supreme Court doesn't consider such a "patentable advance" relevant to step one.  If anything, "claimed" or "patentable advances" are the stuff of Alice step two, and certainly for the Patent Act's substantive patentability requirements, 35 U.S.C. §§102-103.  But not for Alice step one.

    III.  Affinity Labs Solidifies the "Patentable Advance" Inquiry as Part of Step One—Without Discussion or Debate.

    Given Enfish's various pressure points, as described above, one would've thought subsequent cases would've tried to limit or distinguish Enfish, whether because it was technology-focused, predicated on dicta in a different step (step two), or otherwise so unique as to be limited to its facts.  See, e.g., Miller v. U.S. Steel Corp., 902 F.2d 573, 575 (7th Cir. 1990) (the "polite formula for overruling").  Not so.  Four months later, in Affinity Labs, the court effectively sealed Enfish's transformation of step one.  838 F.3d at 1257-58.

    Conclusion

    Whether in Enfish or another imminent case, the Federal Circuit was right to interpret "directed to," as used in Alice step one.  The problem is that Enfish and its subsequent cases (such as Affinity Labs) proceeded to make its "patentable advance" interpretation not just inconsistent with Alice's "directed to" step; but nearly unrecognizable in view of it.  And it is wholly unclear that Enfish did much to stem the ineligibility tide.  After all, a recent study documenting §101 outcomes at the Federal Circuit (in published post-Alice cases) concluded that, regardless of technology or other such distinctions, some 82.1% of claims before the Federal Circuit "succumb" (in Enfish's words) to Mayo-Alice step one.  See Lessons From a Quantitative Analysis of the Federal Circuit's Section 101 Decisions Since Alice, by C. Graham Gerst & Paul Choi, IP Watchdog (Sept. 2, 2020).  Accordingly, as to the Federal Circuit's "patentable-advance" interpretation and the reasoning and process that produced it, patent lawyers should ask the court to revisit and correct this misinterpretation.

  • By Kevin E. Noonan

    USPTO SealHaving heard oral argument at a hearing held on Monday, May 18th, the Patent Trial and Appeal Board today entered its decision on these motions in Interference No 106,115 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC").

    The Broad had four substantive motions to be decided by the Board:  Broad's Substantive Motion No. 1, requesting the Board to find (as it had in the earlier, 105,048 interference between these parties) that there was no interference-in-fact; Substantive Motion No. 2 to Substitute the Count; Broad's Substantive Motion No. 3 to de-designate claims as not corresponding to Count 1; and Broad's Substantive Motion No. 4 for priority to U.S. Provisional Application No. 61/736,527.

    CVC for its part filed only two motions to be decided by the Board:  CVC's Motion No. 1 was to be accorded the benefit of priority to three earlier-filed provisional applications for Count 1 of the Interference as declared; and CVC's Responsive Contingent Motion No. 2 was to be accorded the benefit of priority to three earlier-filed provisional applications contingent on the PTAB granting the Broad's Motion No. 2 to Substitute the Count of the interference.

    CVC also filed Miscellaneous Motion No. 2 to Exclude Evidence on April 2nd to exclude four references proffered by the Broad on the grounds that four prior art references should not be considered by the Board because they were not cited in any of Broad's papers; declarations from several individuals, including some of Broad's inventors, are inadmissible as hearsay because these individuals had not been made available for deposition; and certain expert testimony fails the Supreme Court's Daubert test for expert testimony admissibility.

    In its decision today, the PTAB denied Broad's Motion No. 1 that the interference be dissolved because CVC was estopped by the decision in the earlier interference between the parties (No. 105,048).  This decision is the most significant of the decisions handed down on the parties' motions, because the interference will now proceed to the priority phase.  The Board also denied the Broad's Mo No. 2 to substitute the Count, and its Motion No. 3 to designate claims corresponding and not corresponding to the changed Count.  Finally, with regard to the Broad’s claims, the Board granted Motion No. 4 to be accorded priority benefit to U.S. Provisional Application No. 61/736,527, having a filing date of December 12, 2012.

    As for CVC's motions, the Board granted-in-part CVC's Motion No. 1, according priority benefit to USSN 61/757,640, filed January 28, 2013; because this application has a later filing date than the Broad's '527 application CVC remains the Junior Party.  The Board dismissed CVC's Motion No. 2, which was contingent on the Board granting Broad's motion to substitute the Count, and granted-in-part CVC's motion to exclude evidence as to Exhibits that were not relied upon by the parties or the Board.

    The consequences of these decisions are that the interference will proceed to the priority phase, and Broad's status as Senior Party is unchanged; accordingly, CVC has the burden of showing earlier conception of the subject matter defined in the Count as declared.  The Board redeclared the interference to reflect the benefit of priority decided in these motions.  It also issued an order establishing times for the parties to file priority motions, oppositions, replies, and other motions:

    TIME PERIOD 11 — 23 October 2020 — JUNIOR PARTY ONLY file priority motion

    TIME PERIOD 12 — 4 December 2020 — SENIOR PARTY ONLY file priority motion

    TIME PERIOD 13 — 29 January 2021 — File oppositions to all motions

    TIME PERIOD 14 — 26 February 2021 — File all replies

    TIME PERIOD 15 — 2 April 2021 — File request for oral argument, File list of issues to be considered, File motions to exclude File observations

    TIME PERIOD 16 — 23 April 2021 — File oppositions to motions to exclude, File response to observations

    TIME PERIOD 17 — 7 May 2021 — File replies to oppositions to motions to exclude

    ORAL ARGUMENT DATE (if ordered) — TBD

    More in depth analysis and discussion of these decisions and their consequences will be provided in future posts.

  •     By Donald Zuhn

    Federal Circuit SealEarlier today, the Federal Circuit vacated the final written decision by the U.S. Patent and Trademark Office Patent Trial and Appeal Board in an inter partes review involving Appellant Snyders Heart Valve LLC and Appellee St. Jude Medical, LLC, and remanded for proceedings consistent with the Court's decision in Arthrex, Inc. v. Smith & Nephew, Inc., 941 F.3d 1320 (Fed. Cir. 2019).  Snyders argued that the final written decision at issue on appeal violated the Constitution's Appointments Clause because it was rendered by an unconstitutionally appointed panel of Administrative Patent Judges.  Snyders also argued that the remedy in Arthrex is insufficient because it does not allow for review of the Board's decisions by a superior officer and is inconsistent with Congress' intent that Administrative Patent Judges act independently.  Snyders further argued that due to the unique circumstances of its case, it was entitled to greater relief than afforded under Arthrex.

    With respect to Snyders' first argument, the Court indicated that the issue had been decided in Arthrex, and that Snyders was entitled to vacatur and remand for a hearing before a properly appointed Board.  The Court did not address Snyders second argument, noting that it was bound by Arthrex.

    With respect to Snyders' third argument, Snyders explained that USPTO Director Andre Iancu had served as counsel for St. Jude Medical LLC in a parallel proceeding prior to his appointment as Director.  Although Director Iancu had recused himself from the instant case, Snyders argued that the Director's conflict should be imputed to all USPTO employees and that his recusal should impact the remedy available to Snyders.  The Court, however, found Snyders' argument to be without merit, noting that the Deputy Director has the authority, under 35 U.S.C. § 3(b)(1), "to act in the capacity of the Director in the event of the absence or incapacity of the Director," and that a conflict requiring recusal qualifies as an "incapacity" within the meaning of the statute.

    St. Jude's argued on appeal that because Snyders expressly waived its Arthrex-based challenge in a companion appeal, the Court should deem the argument to have been waived in the instant appeal.  The Court, however, explained that "Snyders was not obligated to press every argument available to it in a different appeal to maintain its rights in this one," noting that the companion appeal addressed inter partes reviews of a different patent than the one at issue in the instant appeal, and therefore determined that Snyders had not waived its Arthrex-based challenge in the instant appeal.

    The Court concluded that "Snyders is entitled to the same relief given to the Arthrex appellant and no more," and therefore vacated and remanded the Board's final written decision.

    Snyders Heart Valve LLC v. St. Jude Medical, LLC (Fed. Cir. 2020)
    Nonprecedential disposition
    Panel: Circuit Judges Newman, O'Malley, and Taranto
    Per curiam opinion

  • By Donald Zuhn

    USPTO Extends Cancer Immunotherapy Pilot Program

    USPTO SealIn a notice published earlier this summer in the Federal Register (85 Fed. Reg. 41570), the U.S. Patent and Trademark Office announced that it was extending the Cancer Immunotherapy Pilot Program.  According to the Office's notice, the Cancer Immunotherapy Pilot Program has been extended to June 30, 2022, and all parameters will remain the same as in the original pilot program.

    The Cancer Immunotherapy Pilot Program was initiated on June 29, 2016 (see "USPTO Implements Pilot Program to Support President's National Cancer Moonshot") to provide for earlier review of patent applications pertaining to cancer immunotherapy in support of the "National Cancer Moonshot," an initiative of the Obama Administration to achieve ten years' worth of cancer research from 2016 to 2021 (see "FACT SHEET: Investing in the National Cancer Moonshot").  Under the Cancer Immunotherapy Pilot Program, applications containing at least one claim reciting a method of treating a cancer using immunotherapy are advanced out of turn for examination if the applicant files a grantable petition to make special, with the goal of completing examination of the application within twelve months of special status being granted.  In order to participate in the Cancer Immunotherapy Pilot Program, an applicant must satisfy the following requirements:

    (1) File a petition to make special under 37 C.F.R. § 1.102(d) in a non-reissue, nonprovisional utility application filed under 35 U.S.C. § 111(a), or an international application that has entered national stage under 35 U.S.C. § 371.  The petition must be filed at least one day prior to the date that notice of a first Office action (which may be an Office action containing only a restriction requirement) appears on PAIR, or with a Request for Continued Examination (RCE).  For applications in which the claimed cancer immunotherapy is the subject of an active Investigational New Drug (IND) application, a petition to make special may be accepted any time prior to appeal or final rejection.  The Office recommends that applicants use form PTO/SB/443 for filing the petition, as the form contains check boxes that will allow the applicant to comply with several certification requirements under the pilot program.

    (2) The application cannot contain more than three independent claims, more than twenty total claims, or any multiple dependent claims.  For applications not meeting this requirement, an applicant must file a preliminary amendment to cancel the excess claims or multiple dependent claims at the time the petition to make special is filed.

    (3) The application must include at least one claim to a method of treating a cancer using immunotherapy, and such claim must "encompass[] a method of ameliorating, treating, or preventing a malignancy in a human subject wherein the steps of the method assist or boost the immune system in eradicating cancerous cells."  Examples of acceptable claims include those directed to "the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells," "the co-administration of biological adjuvants (e.g., interleukins, cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in combination with conventional therapies for treating cancer such as chemotherapy, radiation, or surgery," "administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth," or "in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines."

    (4) If restriction is required, the applicant must agree to make an election without traverse in a telephonic interview, and elect an invention directed to a method of treating a cancer using immunotherapy.  The applicant will be given two working days to respond to an examiner's request for an election, and in the event that the applicant fails to respond within that period, the examiner will treat the first group of claims directed to a method of treating a cancer using immunotherapy as being constructively elected without traverse.

    (5) The application cannot have been previously granted special status.

    (6) The petition to make special must be filed electronically via the EFS-Web, and the document description "Petition for Cancer Immunotherapy Pilot" must be selected for the petition.

    (7) If the application has not been published, the applicant must file a request for early publication in compliance with 37 C.F.R § 1.219 with the petition to make special (or a rescission of a nonpublication request if one was filed).

    For the purposes of the pilot program, the fee for a petition to make special under 37 C.F.R. § 1.102(d) has been waived by the Office.

    In its notice extending the Cancer Immunotherapy Pilot Program, the Office noted that as of the date of the notice, more than 500 petitions requesting participation in the pilot program have been filed, and 167 patents have been granted under the pilot program.


    USPTO and IMPI Extend PPH Pilot Program

    Mexican Patent Office - Instituto Mexicano de la Propiedad IndustrialIn a notice published earlier this summer in the Official Gazette (1476 OG 56), the U.S. Patent and Trademark Office announced that the USPTO and Mexican Institute of Industrial Property (IMPI) have agreed to extend the Patent Prosecution Highway (PPH) Pilot Program between the two offices until June 30, 2022.  As a result of the extension, the USPTO will treat as timely any PPH request, based on IMPI work, filed with the USPTO on or before June 30, 2022.


    INAPI Transitioning to Global PPH Pilot Program

    INAPIIn a notice issued by the U.S. Patent and Trademark Office earlier this summer, the USPTO announced that it had been informed by the National Institute of Industrial Property of Chile (INAPI) that INAPI would be participating in the Global PPH pilot program effective July 6, 2020.  In November of 2018, the USPTO had commenced a Patent Prosecution Highway (PPH) pilot program in which an applicant whose claims were determined allowable/patentable in an application filed with INAPI could have the corresponding application filed with the USPTO advanced out of turn for examination.  In January of 2014, the USPTO began participating in the Global PPH pilot program, which consolidated and replaced numerous prior PPH programs, streamlining and simplifying the PPH process for both applicants and Global PPH participating offices.  INAPI's participation in the Global PPH pilot program will supersede the bilateral PPH pilot program that previously existed between the USPTO and INAPI.


    USPTO Releases Revised MPEP

    MPEP CoverThe U.S. Patent and Trademark Office announced via a Patent Alert e-mail distributed earlier this summer and a notice in the Federal Register (85 Fed. Reg. 41571) that it has released the latest version of the Manual of Patent Examining Procedure (MPEP).  The new version of the MPEP — the Ninth Edition, June 2020 Revision — incorporates updated information on patent examination policy and procedure related to a number of issues, including subject matter eligibility and examination of computer-implemented functional claim limitations.  In particular, chapters 100-1000, 1200-1500, and 1700-2800 of the MPEP have been revised.  The Office notes that updated sections are indicated by a revision indicator of [R-10.2019], which means these sections have been updated to reflect USPTO patent practice and relevant case law as of October 31, 2019.  The new version of the MPEP can be accessed here.  Suggestions for improving the form and content of the MPEP can be submitted via e-mail to mpepfeedback@uspto.gov, via the IdeaScale® tool at https://uspto-mpep.ideascale.com/a/index, or by regular mail addressed to the Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of the Editor, Manual of Patent Examining Procedure.

  • CalendarSeptember 8, 2020 – "Compulife: Datascraping and Trade Secret Law" (Intellectual Property Owners Association) – 12:00 pm to 1:00 pm (ET)

    September 8, 2020 – IPWatchdog Virtual CON2020 – The Current State of Patent Eligibility Caselaw – 12:30 pm (ET)

    September 8, 2020 – IPWatchdog Virtual CON2020 – A Bridge of Tears for Life Sciences – 12:45 pm (ET)

    September 8, 2020 – IPWatchdog Virtual CON2020 – Hatch-Waxman and IPR Strategy – 2:15 pm (ET)

    September 9, 2020 – IPWatchdog Virtual CON2020 – Keynote: Tricia Thompkins, EVP, General Counsel and Secretary, Perry Ellis International, Inc. – 12:30 pm (ET)

    September 9, 2020 – IPWatchdog Virtual CON2020 – Leveraging Intellectual Property to Raise Structured Capital in Life Sciences – 12:30 pm (ET)

    September 9, 2020 – IPWatchdog Virtual CON2020 – IP as an Asset Class: Valuing Assets in Support of Monetization Strategy – 12:45 pm (ET)

    September 9, 2020 – IPWatchdog Virtual CON2020 – Litigation Finance: Funding Patent Infringement Litigation – 2:15 pm (ET)

    September 10, 2020 – "Myths of Litigated Patents" (LexisNexis IP and IPWatchdog) – 12:00 pm (ET).

    September 10, 2020 – "Is Alice Pulling Manufacturing Patents Down the Rabbit Hole?" (Intellectual Property Owners Association) – 12:45 pm to 1:45 pm (ET)

    September 11, 2020 – IP, Technology & Social Justice in the Age of Coronavirus (Center for Intellectual Property, Information & Privacy Law at UIC John Marshall Law School and Institute for Intellectual Property & Social Justice) – 7:40 am to 3:00 pm (CT)

    September 14, 2020 – IPWatchdog Virtual CON2020 – Enforcing & Licensing 5G SEPs: An Innovator’s Perspective – 12:45 pm (ET)

    September 14, 2020 – IPWatchdog Virtual CON2020 – High-Tech Patent Litigation Trends: 101 and the Return of Competitor Lawsuits – 2:15 pm (ET)

    September 14, 2020 – IPWatchdog Virtual CON2020 – Preparing and Prosecuting Patents that Hold up to Challenge – 3:45 pm (ET)

    September 15, 2020 – "Traps for the Unwary Prosecutor: What Practitioners Should Know About US and European Patent Practice" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    September 15, 2020 – IPWatchdog Virtual CON2020 – Keynote: Rochelle Blaustein, Associate General Counsel, Technology Transfer & Intellectual Property, United States Department of Energy – 12:05 pm (ET)

    September 15, 2020 – IPWatchdog Virtual CON2020 – The Growing Importance of Trade Secret Protection – 12:30 pm (ET)

    September 15, 2020 – IPWatchdog Virtual CON2020 – Identifying, Valuing and Protecting Trade Secrets in the 21st Century – 12:45 pm (ET)

    September 15, 2020 – IPWatchdog Virtual CON2020 – The Gender Gap: Addressing STEM Education, Funding & Inventorship – 2:15 pm (ET)

    September 16, 2020 – IPWatchdog Virtual CON2020 – Ethics for IP Attorneys – 1:50 pm (ET)

    September 17, 2020 – IPWatchdog Virtual CON2020 – Keynote: Alden Abbott, General Counsel, FTC – 12:05 pm (ET)

    September 17, 2020 – IPWatchdog Virtual CON2020 – Efficiency in Draftsman Communications – 12:30 pm (ET)

    September 17, 2020 – IPWatchdog Virtual CON2020 – Enhancing Value Throughout the Patent Life Cycle – 2:00 pm (ET)

    September 17, 2020 – IPWatchdog Virtual CON2020 – Establishing a Patent Strategy for the Innovation Lifecycle – 2:15 pm (ET)

    September 23-24, 2020 – Summit on Biosimilars: Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilars Marketplace (American Conference Institute) – virtual conference

    September 23-24, 2020 – FDA Boot Camp (American Conference Institute) – virtual conference

    September 29, 2020 – IPWatchdog Virtual CON2020 – The Future of Monetization – 12:45 pm (ET)

    September 29, 2020 – IPWatchdog Virtual CON2020 – What Can Armor on WWII Planes & Honeybees Tell Us about Innovation Strategy? – 2:00 pm (ET)

    September 29, 2020 – IPWatchdog Virtual CON2020 – Everyone Wants to Be a Unicorn – But What About Patents? – 2:15 pm (ET)

    September 30, 2020 – IPWatchdog Virtual CON2020 – Keynote: Louis Foreman, CEO, Enventys Partners, founder of Edison Nation – 12:05 pm (ET)

    September 30, 2020 – IPWatchdog Virtual CON2020 – How China is Changing the Global Patent System – 12:45 pm (ET)

    September 30, 2020 – IPWatchdog Virtual CON2020 – Solutions for the U.S. Patent System – 2:15 pm (ET)

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Is Alice Pulling Manufacturing Patents Down the Rabbit Hole?" on September 10, 2020 from 12:45 pm to 1:45 pm (ET).  John Cheek of DRiV Inc. and Timothy McAnulty and Jeffrey Totten of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will discuss how recent decisions from the Federal Circuit in American Axle have put manufacturing, mechanical, and electrical patents at risk, and how the Alice/Mayo test for patent eligibility is not being applied to method of manufacturing patents.  The panel will discuss the following issues:

    • Do these cases push the Alice/Mayotest too far?
    • Do they further conflate patent eligibility with obviousness or enablement?
    • Do they put manufacturing, mechanical, and electrical patents more at risk for eligibility challenges (and cancellation)?

    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.

  • LexisNexisLexisNexis IP and IPWatchdog and will be offering a webinar entitled "Myths of Litigated Patents" on September 10, 2020 at 12:00 pm (ET).  Dr. Sean Tu, Professor, WVU College of Law; Megan McLoughlin of LexisNexis® IP; and Gene Quinn of IPWatchdog will discuss whether patent examiners who issue litigated patents have common characteristics?  While intuition would argue that those examiners who issue the most patents (approximately one patent every three business days) would exhibit a higher litigation rate, surprisingly, two studies by Professor Sean Tu suggest that this is wrong.  The panel will address the following issues:

    • Which types of examiners tend to issue patents that later undergo litigation
    • Whether examiners who are "rubber stamping" patents issue litigated patents at a disproportionately higher rate
    • Whether examiners with less experience are issuing more litigated patents
    • The issues at stake during prosecution for different types of examiners
    • How this knowledge can impact your prosecution practice

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