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  • Whither CRISPR? University of California/Berkeley Granted Another CRISPR Patent

    By Kevin E. Noonan —

    University of California-BerkleyThe U.S. Patent and Trademark Office granted U.S. Patent No. 10,113,167 today to the University of California/Berkeley, directed to an aspect of its CRISPR technology (where CRISPR is an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats).  The interference between the Broad Institute and the University of California/Berkeley over patents directed to CRISPR technology has been in the spotlight over the past few years (see "CRISPR Interference Declared"; "PTAB Decides CRISPR Interference — No interference-in-fact"; "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning"; "University of California/Berkeley Appeals Adverse CRISPR Decision by PTAB"; and "Berkeley Files Opening Brief in CRISPR Appeal").  And while the Broad was successful in getting the Federal Circuit to affirm the PTAB's decision that there was no interference-in-fact between the parties' claims (see "Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018): Federal Circuit Affirms PTAB in Appeal of CRISPR Interference") and there have been reports of the outcomes of other skirmishes between the parties in the meantime (see "The CRISPR Chronicles — Broad Institute Wins One and Loses One"), questions remain about how the rights to this technology will be apportioned between the parties and useful, reliable patent licenses will be granted to permit robust development and fulfillment of the many promises of CRISPR in a wide variety of genetic contexts.

    The Broad's extensive patent portfolio survived the interference, particularly these patents directly at issue:

    • U.S. Patent No. 8,697,359 — claims 1-20
    • U.S. Patent No. 8,771,945 — claims 1-29
    • U.S. Patent No. 8,795,965 — claims 1-30
    • U.S. Patent No. 8,865,406 — claims 1-30
    • U.S. Patent No. 8,871,445 — claims 1-30
    • U.S. Patent No. 8,889,356 — claims 1-30
    • U.S. Patent No. 8,895,308 — claims 1-30
    • U.S. Patent No. 8,906,616 — claims 1-30
    • U.S. Patent No. 8,932,814 — claims 1-30
    • U.S. Patent No. 8,945,839 — claims 1-28
    • U.S. Patent No. 8,993,233 — claims 1-43
    • U.S. Patent No. 8,999,641 — claims 1-28

    The Berkeley application-in-interference, U.S. Application No. 13/842,859, published as U.S. Patent Application Publication No. US 2014/0068797, remains in Patent Office limbo during the pendency of court proceedings; these claims include the following:

    165.  A method of cleaving a nucleic acid comprising contacting a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system comprising
        a) a Cas9 protein; and
        b) a single molecule DNA-targeting RNA comprising
            i) a targeter-RNA that hybridizes with the target sequence, and
            ii) an activator-RNA that hybridizes with the targeter-RNA to form a double-stranded RNA duplex of a protein-binding segment,
        wherein the activator-RNA and the targeter-RNA are covalently linked to one another with intervening nucleotides,
        wherein the single molecule DNA-targeting RNA forms a complex with the Cas9protein,
        whereby the single molecule DNA-targeting RNA targets the target sequence, and the Cas9 protein cleaves the target DNA molecule.

    203.  An engineered and/or non-naturally occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system comprising
        a) a Cas9 protein, or a nucleic acid comprising a nucleotide sequence encoding said Cas9 protein; and
        b) a single molecule DNA-targeting RNA, or a nucleic acid comprising a nucleotide sequence encoding said single molecule DNA-targeting RNA;
        wherein the single molecule DNA-targeting RNA comprises:
            i) a targeter-RNA that is capable of hybridizing with a target sequence in a target DNA molecule, and
            ii) an activator-RNA that is capable of hybridizing with the targeter-RNA to form a double-stranded RNA duplex of a protein-binding segment,
        wherein the activator-RNA and the targeter-RNA are covalently linked to one another with intervening nucleotides; and
        wherein the single molecule DNA-targeting RNA is capable of forming a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule,
    whereby said system is capable of cleaving or editing the target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule.

    224.  A Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system comprising:
        a Cas9 protein; and
        a single molecule DNA-targeting RNA, or a nucleic acid comprising a nucleotide sequence encoding said single molecule DNA-targeting RNA,
        wherein the single molecule DNA-targeting RNA comprises:
            i) a targeter-RNA that is capable of hybridizing with a target sequence in a target DNA molecule, and
            ii) an activator-RNA that is capable of hybridizing with the targeter-RNA to form a double-stranded duplex of a protein-binding segment,
        wherein i) and ii) are arranged in a 5' to 3' orientation and are covalently linked to one another with intervening nucleotides;
        wherein the single molecule DNA-targeting RNA is capable of forming a complex with the Cas9 protein and hybridization of the targeter-RNA to the target sequence is capable of targeting the Cas9 protein to the target DNA molecule, and
        wherein the single molecule DNA-targeting RNA comprises one or more sequence modifications compared to a sequence of a corresponding wild type tracrRNA and/or crRNA.

    The '167 patent granted today, includes the following claims:

    1.  A non-naturally occurring DNA-targeting RNA, or a nucleic acid encoding the non-naturally occurring DNA-targeting RNA, wherein the non-naturally occurring DNA-targeting RNA comprises: (a) a targeter-RNA comprising: (i) a first nucleotide sequence that is complementary to a target sequence of a target DNA molecule, and (ii) a second nucleotide sequence that hybridizes with an activator-RNA, wherein the first and second nucleotide sequences are heterologous to one another; and (b) the activator-RNA, which hybridizes with the second nucleotide sequence of the targeter-RNA to form a double-stranded RNA (dsRNA) duplex of a protein-binding segment, wherein the activator-RNA hybridizes with the targeter-RNA to form a total of 8 to 15 base pairs, wherein the non-naturally occurring DNA-targeting RNA is capable of forming a complex with a Cas9 polypeptide and targeting the complex to the target sequence of the target DNA molecule.

    12.  A non-naturally occurring DNA-targeting RNA that comprises: (a) a targeter-RNA comprising a nucleotide sequence that is complementary to a target sequence of a target DNA molecule, and (b) an activator-RNA that hybridizes with the targeter-RNA to form a double-stranded RNA (dsRNA) duplex of a protein-binding segment, wherein the activator-RNA hybridizes with the targeter-RNA to form a total of 8 to 15 base pairs, wherein the non-naturally occurring DNA-targeting RNA comprises one or more of: a non-natural internucleoside linkage, a nucleic acid mimetic, a modified sugar moiety, and a modified nucleobase, and wherein the non-naturally occurring DNA-targeting RNA is capable of forming a complex with a Cas9 polypeptide and targeting the complex to the target sequence of the target DNA molecule.

    19.  One or more nucleic acids encoding a non-naturally occurring DNA-targeting RNA that comprises: (a) a targeter-RNA comprising a nucleotide sequence that is complementary to a target sequence of a target DNA molecule, and (b) an activator-RNA that hybridizes with the targeter-RNA to form a double-stranded RNA (dsRNA) duplex of a protein-binding segment, wherein the activator-RNA hybridizes with the targeter-RNA to form a total of 8 to 15 base pairs, wherein the non-naturally occurring DNA-targeting RNA is capable of forming a complex with a Cas9 polypeptide and targeting the complex to the target sequence of the target DNA molecule, and wherein the one or more nucleic acids comprises a first nucleotide sequence encoding the targeter-RNA and a second nucleotide sequence encoding the activator-RNA; wherein the first nucleotide sequence, the second nucleotide sequence, or both, is operably linked to a heterologous transcriptional control sequence and/or a heterologous translational control sequence.

    36.  A composition comprising: (1) a non-naturally occurring DNA-targeting RNA, or a nucleic acid encoding the non-naturally occurring DNA-targeting RNA, wherein the non-naturally occurring DNA-targeting RNA comprises: (a) a targeter-RNA comprising a nucleotide sequence that is complementary to a target sequence of a target DNA molecule, and (b) an activator-RNA that hybridizes with the targeter-RNA to form a double-stranded RNA (dsRNA) duplex of a protein-binding segment, wherein the activator-RNA hybridizes with the targeter-RNA to form a total of 8 to 15 base pairs, wherein the non-naturally occurring DNA-targeting RNA is capable of forming a complex with a Cas9 polypeptide and targeting the complex to the target sequence of the target DNA molecule; and (2) one or more of: a nuclease inhibitor, a buffering agent, a detergent, a polyamine, an adjuvant, a wetting agent, a stabilizing agent, an antioxidant, and a complexing agent.

    54.  A composition comprising: (1) a Cas9 polypeptide, or a nucleic acid encoding the Cas9 polypeptide; and (2) a non-naturally occurring DNA-targeting RNA, or a nucleic acid encoding the non-naturally occurring DNA-targeting RNA, wherein the non-naturally occurring DNA-targeting RNA comprises: (a) a targeter-RNA comprising: (i) a first nucleotide sequence that is complementary to a target sequence of a target DNA molecule, and (ii) a second nucleotide sequence that hybridizes with an activator-RNA, wherein the first and second nucleotide sequences are heterologous to one another; and (b) the activator-RNA, which hybridizes with the second nucleotide sequence of the targeter-RNA to form a double-stranded RNA (dsRNA) duplex of a protein-binding segment, wherein the activator-RNA hybridizes with the targeter-RNA to form a total of 8 to 15 base pairs, wherein the non-naturally occurring DNA-targeting RNA is capable of forming a complex with the Cas9 polypeptide and targeting the complex to the target sequence of the target DNA molecule.

    While the Broad was quicker off the mark in applying for and having granted patents on its flavor(s) of CRISPR, UC/Berkeley has a number of pending applications, including U.S. Serial No. 14/942,782, as well as the following eight other applications:

    • U.S. Application No. 15/435,233, filed on 2-16-2017, which claims the benefit of U.S. Application No. 15/138,604;
    • U.S. Application No. 15/925,544, filed on 3-19-2018, which claims the benefit of U.S. Application No. 15/138,604;
    • U.S. Application No. 15/947,700, filed on 4-6-2018, which claims the benefit of U.S. Application No. 15/138,604;
    • U.S. Application No. 15/947,718, filed on 4-6-2018, which claims the benefit of U.S. Application No. 15/138,604;
    • U.S. Application No. 15/981,808, filed on 5-16-2018, which claims the benefit of U.S. Application No. 15/138,604;
    • U.S. Application No. 15/981,809, filed on 5-16-2018, which claims the benefit of U.S. Application No. 15/138,604;
    • U.S. Application No. 16/136,159, filed on 9-19-2018, which claims the benefit of U.S. Application No. 15/138,604; and
    • U.S. Application No. 16/136,165, filed on 9-19-2018, which claims the benefit of U.S. Application No. 15/138,604.

    Today's granted patent joins previously granted U.S. Patent No. 10,000,772, which contains claims directed to these embodiments of the invention:

    1.  A method of modifying a target DNA molecule, the method comprising: contacting a target DNA molecule having a target sequence with a complex comprising: (a) a Cas9 protein; and (b) a DNA-targeting RNA comprising: (i) a targeter-RNA that hybridizes with the target sequence, and (ii) an activator-RNA that hybridizes with the targeter-RNA to form a double-stranded RNA (dsRNA) duplex of a protein-binding segment, wherein the activator-RNA hybridizes with the targeter-RNA to form a total of 10 to 15 base pairs, wherein said contacting takes place outside of a bacterial cell and outside of an archaeal cell, thereby resulting in modification of the target DNA molecule.

    This patent has eight pending related applications:

    • U.S. Application No. 15/138,604, filed on 4-26-2016, which claims the benefit of U.S. Application No. 14/685,502;
    • U.S. Application No. 15/435,233, filed on 2-16-2017, which claims the benefit of U.S. Application No. 14/685,502;
    • U.S. Application No. 15/947,700, filed on 4-6-2018, which claims the benefit of U.S. Application No. 14/685,502;
    • U.S. Application No. 16/136,159, filed on 9-19-2018, which claims the benefit of U.S. Application No. 14/685,502;
    • U.S. Application No. 15/925,544, filed on 3-19-2018, which claims the benefit of U.S. Application No. 14/685,502;
    • U.S. Application No. 15/947,718, filed on 4-6-2018, which claims the benefit of U.S. Application No. 14/685,502;
    • U.S. Application No. 15/981,808, filed on 5-16-2018, which claims the benefit of U.S. Application No. 14/685,502;
    • U.S. Application No. 15/981,809, filed on 5-16-2018, which claims the benefit of U.S. Application No. 14/685,502;
    • U.S. Application No. 16/136,165, filed on 9-19-2018, which claims the benefit of U.S. Application No. 14/685,502; and
    • U.S. Application No. 15/343,156, filed on 11-3-2016, which claims the benefit of U.S. Application No. 14/685,502.

    With regard to today's issued claims, they are not limited to the type of cell in which the CRISPR reaction occurs (nor, indeed, are limited to any cell at all).  The subject matter eligibility of the claimed RNA molecules is presumably supported by limitations to "non-naturally occurring" (reminiscent of limiting transgenic animals to "non-human" embodiments) as well as specific embodiments of non-naturally occurring nucleic acid forms (comprising a "non-natural internucleoside linkage, a nucleic acid mimetic, a modified sugar moiety, and a modified nucleobase"); indeed, the prosecution file history shows applicants overcame subject matter eligibility rejections under 35 U.S.C. § 101.  While there are dependent claims directed to more specific embodiments of the claimed RNAs, the breadth of scope, necessarily limited extent of disclosure of specific embodiments, and functional characterization of the claimed RNAs (e.g., "the activator-RNA, which hybridizes with the second nucleotide sequence of the targeter-RNA to form a double-stranded RNA (dsRNA) duplex of a protein-binding segment") raise legitimate questions regarding whether these claims will stand up to inevitable challenge on 35 U.S.C. § 112 grounds.

    All this is to say that the patent situation remains somewhat murky, at least with regard to which entity, or both, or another, will ultimately have sufficiently strong or comprehensive patent protection to give licensees confidence in their rights to develop CRISPR technology to fulfill its great promise.

  • Supreme Court to Decide if Government Can Bring AIA Proceedings

    By Josh Rich —

    Supreme Court Building #1On Friday, October 26, 2018, the Supreme Court granted certiorari in Return Mail, Inc. v. U.S. Postal Service, in order to answer the question whether the government can bring post-grant review proceedings under the Leahy-Smith America Invents Act, or AIA.  Specifically, the Supreme Court agreed to review whether the government is a "person" under the AIA, as is required to file a petition seeking the institution of AIA review proceedings.

    The case began with Return Mail seeking to license its patent to the Postal Service as early as 2006.  Return Mail is the assignee of U.S. Patent No. 6,826,548, which claims methods, computer programs, and systems for processing undeliverable or returned mail.  Claim 1 covers using encoded data (essentially, a bar code) that is added to the item before mailing to identify the intended recipient and notify the sender with new recipient information to allow the sender to update its records.  Instead of licensing the '548 patent, the Postal Service filed a petition for ex parte reexamination with the U.S. Patent and Trademark Office.  The USPTO instituted the reexamination proceeding, but eventually confirmed the validity of the patent.  Return Mail then filed a complaint against the Postal Service in the Court of Federal Claims.

    Return Mail's complaint against the Postal Service was based on the government's unlicensed use of the invention covered by the '548 patent, but it technically was not a patent infringement suit.  Rather, claims against the government seeking compensation are brought under 28 U.S.C. § 1498(a), an eminent domain statute.  While that action was pending, the Postal Service filed a petition seeking the institution of covered business method ("CBM") review of the '548 patent.

    Return Mail opposed the institution of the CBM review​ on both substantive and procedural grounds, including that the Postal Service lacked standing to file a CBM petition.  Standing in administrative proceedings, like the USPTO's AIA proceedings, is different from the requirement for standing in a court.  Rather than requiring a case or controversy, it requires meeting statutory requirements.[1]  Under § 18(a)(1)(B) of the AIA, for CBM proceedings, "[a] person may not file a petition for a transitional proceeding with respect to a covered business method patent unless the person or the person's real party-in-interest or privy has been sued for infringement of the patent or has been charged with infringement under that patent."  Return Mail challenged the Postal Service's standing on two points:  first, that the government is not a "person" under the AIA; and, second, that the Postal Service had been (or could be) "sued for infringement of the patent" or "charged with infringement of that patent."

    Return Service's challenge of the government's personalty under the AIA arose out of the interplay between the standing and estoppel provisions of the statute.  The estoppel provision, AIA § 18(a)(1)(D), states:

    The petitioner in a transitional proceeding that results in a final written decision under Section 328(a) of title 35, United States Code, with respect to a claim in a covered business method patent, or the petitioner's real party in interest, may not assert, either in a civil action arising in whole or in part under section 1338 of title 28, United States Code, or in a proceeding before the International Trade Commission under section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337), that the claim is invalid on any ground that the petitioner raised during that transitional proceeding.

    The estoppel was viewed as a cornerstone of the CBM process (and other AIA proceedings) and was intended to prevent CBM petitioners from getting more than one bite at the same apple in litigation.  But by its own language, this estoppel does not apply to a proceeding under § 1498 in the Court of Claims.

    Both the PTAB and the majority of the Federal Circuit panel found that the Postal Service satisfied both the requirement that it be a "person" and that it be "sued for infringement of the patent" or "charged with infringement of that patent."  With regard to requirement that the petitioner be a "person," even the Postal Service noted the oddity of it not being subject to estoppel.  However, the panel majority believed that it would be better to assume that the Postal Service was a "person" and allow Congress to fix the estoppel problem, if it so desired.  The majority addressed two further points.  First, it noted that the parties had not discussed the issue in any detail, which would have constituted a waiver if the issue was waivable.  Second, assuming the issue was unwaivable, the majority found that the AIA as a whole suggested that the term should include the government because otherwise the government would not benefit from intervening rights with regard to patents amended during IPRs.

    Judge Newman dissented on the issue of government personalty.  First, she asserted that standing — as an aspect of subject matter jurisdiction — cannot be waived.  She then noted that it was the Court's obligation to ascertain and confirm jurisdiction, which required it to look at the definitions in the statute.  In doing so, she relied on the longstanding rule that, absent an indication otherwise, the presumption has been that the government does not fall within the definition of a "person."  That applies both when the government would benefit from being a "person" and when it would be harmed by fitting in the definition.  And here, where the Federal government (albeit not the Postal Service) argued strongly for the estoppel provision to apply as the AIA was being considered by Congress, the statutory history suggests applying the presumption against government personalty rather than abandoning it.

    In its petition for certiorari, Return Mail challenged both the finding that the Postal Service was a "person" and that it had been sued for patent infringement when Return Mail brought its § 1498 action in the Court of Claims.[2]  With regard to the definition of "person," Return Mail argued that the Federal Circuit's chosen meaning, based on the lack of express Congressional guidance, conflicted with Supreme Court precedent presuming that statutes presumptively exclude the government from the scope of this term.  That is especially true when the construction would be awkward, as Return Mail asserted it was in light of the conflict between the Federal Circuit's construction and the overall intent of the statutory scheme.  In addition, Return Mail asserted that the statutory scheme indicated an intent to exclude the government from the definition of "person."  Finally, Return Mail pointed out that the Federal government already had a role in CBM review, specifically the PTO sitting in judgment over the review.

    The Federal government responded by arguing, first, that Return Mail had not raised the issue below and therefore the dispute had not been fully fleshed out.  Second, even though it acknowledged that the general rule is that the government is not a "person," the government argued that the context of the AIA and the CBM review provision reinforced that the government should be considered a "person" in these circumstances.  The government's argument relied on the fact that the Patent Statute permits the government to obtain patents, yet other sections (such as § 102) limit when "a person shall be entitled to a patent."  Third, the government argued that allowing it to bring CBM petitions was consistent with the statutory intent to allow streamlined review of suspect patents.  Finally, the government argued that this case was a poor vehicle for deciding this issue because the Postal Service was fundamentally different from other Federal agencies because it is more like a business than other agencies.

    In its reply, Return Mail pointed out that this situation is important to patent owners, and has been a recurring issue.  The issue of whether the government is "person" extends to all AIA proceedings, and several have been brought by the Federal government.  In addition, Return Mail pointed out (as had one of the amici that filed a brief in support of Return Mail's petition) that the government was seeking to act as both a sovereign power and a private party in the same proceeding.

    The Supreme Court granted certiorari only on the first issue identified by Return Mail, whether the government is a "person" in the context of the AIA's CBM proceeding.  Thus, by the middle of next year, we should know whether government agencies are "persons," permitted to bring AIA proceedings.

    [1] Here, however, in the context of a CBM review, administrative standing incorporates the Article III courts' requirements for standing:

     A petitioner may not file with the Office a petition to institute a covered business method patent review of the patent unless the petitioner, the petitioner's real party-in-interest, or a privy of the petitioner has been sued for infringement of the patent or has been charged with infringement under that patent.  Charged with infringement means a real and substantial controversy regarding infringement of a covered business method patent exists such that the petitioner would have standing to bring a declaratory judgment action in Federal court.

    37 C.F.R. § 42.302.

    [2] The Federal Circuit found that a § 1498 action was similar enough to a patent infringement action to give rise to standing, even though it clearly is not a patent infringement action and does not permit certain remedies (such as injunctive relief, treble damages, and attorneys' fees for an exception case).  In doing so, the unanimous panel found that "infringement" did not necessarily mean an action brought solely on the basis of the Patent Act.

  • Conference & CLE Calendar

    CalendarOctober 30, 2018 – "Obviousness Standard: Leveraging Latest PTO and Court Guidance — Overcoming Challenges of Obviousness and Attacks on Patent Validity" (Strafford) – 1:00 to 2:30 pm (EDT)

    October 30, 2018 – European biotech patent law update (D Young & Co) – 5:00 am, 8:00 am, and 1:00 pm (EDT)

    October 30, 2018 – "University Technology Transfer and Licensing Agreements — Determining Type of Transfer Agreement to Use, Structuring Key Provisions, Overcoming Unique Challenges" (Strafford) – 1:00 to 2:30 pm (EDT)

    October 31, 2018 – "AIA Estoppel: A New Flavor of Collateral Estoppel and/or Res Judicata?" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    November 1, 2018 – "When Patents Go Wrong . . . And What To Do About It" (J A Kemp) – 3:30 to 4:30 pm (Greenwich Mean Time)

    November 7, 2018 – "Antibody Patenting After Amgen v. Sanofi: U.S. and European Perspectives — Meeting Written Description and Obviousness Requirements" (Strafford) – 1:00 to 2:30 pm (EST)

    November 8, 2018 – "Deciphering the PTAB's Standard Operating Procedure Changes: A Game Changer for Post-Grant Proceedings" (Technology Transfer Tactics) – 1:00 pm to 2:00 pm (ET)

  • IPO Webinar on AIA Estoppel

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "AIA Estoppel: A New Flavor of Collateral Estoppel and/or Res Judicata?" on October 31, 2018 from 2:00 to 3:00 pm (ET).  Herbert Hart of McAndrews of Held & Malloy, Ltd. will moderate a panel consisting of Emily Johnson of Amgen Inc.; Barbara McCurdy of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; and the Hon. James Peterson, Chief District Judge, U.S. District Court for the Western District of Wisconsin.  The panel will explore the potential impact of statutory and rule-based estoppel resulting from Final Written Decisions of the Patent Trial and Appeal Board, including:

    • What is the likely impact of AIA estoppel at the PTAB and in the district courts?
        – Is Shaw still alive after SAS?
        – What's the likely impact of SAS on the scope of estoppel?
        – How does the Maxlinear decision change the potential scope of estoppel?
    • How should the terms "skilled searcher," "diligent search," and "reasonably could have been expected to discover" be interpreted for estoppel purposes?
    • How should non-documentary prior art be handled in a district court, even if it relates to publications used in an IPR?
    • When and how should the estoppel defense be raised at the PTAB? In a district court?

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

  • Webinar on Changes to PTAB’s Standard Operating Procedures

    Technology Transfer Tactics will be offering a webinar entitled "Deciphering the PTAB's Standard Operating Procedure Changes: A Game Changer for Post-Grant Proceedings" on November 8, 2018 from 1:00 pm to 2:00 pm (ET).  Tyson Benson of Harness, Dickey & Pierce, PLC will address revisions to the PTAB's Standard Operating Procedures ("SOPs") relating to paneling of matters before the PTAB and precedential and informative decisions.  The presentation will also cover the following topics:

    • Understanding the revisions to SOP1 that explains the revised procedures for panel assignment;
    • The process for designating panels with more than three judges;
    • Revisions to SOP2 that creates a Precedential Opinion Panel (POP);
    • Understanding the functionality of the POP;
    • Potential impact on licensing and patent value;
    • Best practices for TTOs and attorneys when:
        – Preparing initial patent claims
        – Preparing for:
            inter partes reviews
            post-grant reviews
            covered business method patent reviews
            derivation proceedings

    The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics

  • Webinar on Patent “Restoration” Situations

    J A KempJ A Kemp will be offering a webinar entitled "When Patents Go Wrong . . . And What To Do About It" on November 1, 2018 from 3:30 to 4:30 pm (Greenwich Mean Time).  Andy Bentham of J A Kemp will look at grace periods worldwide in relation to inventor disclosures, restoration of priority, late national phase entry and other "restoration" situations relating to missed renewal fee payments and other deadlines, and also consider how to adapt your filing strategy to account for different scenarios that may arise as a result of missed deadlines.

    Those wishing to register can do so here.

  • Webinar on Antibody Patenting After Amgen v. Sanofi

    Strafford #1Strafford will be offering a webinar entitled "Antibody Patenting After Amgen v. Sanofi: U.S. and European Perspectives — Meeting Written Description and Obviousness Requirements" on November 7, 2018 from 1:00 to 2:30 pm (EST).  Hazel Ford of Mathys & Squire, and Jeffrey M. Jacobstein and Amanda K. Murphy of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel on the patentability requirements in the USPTO and EPO for claiming a broad genus of antibodies, recent case law that could impact those claims, and how to best protect antibody inventions in light of the recent developments.  The webinar will review the following issues:

    • How broadly can the applicant claim? How much support is needed on a filing?
    • What are the differences between U.S. requirements and EPO requirements?
    • What is a sufficient description of a genus? Can functional language be included?
    * When can post-filing data be used?

    The registration fee for the webcast is $297.  Those interested in registering for the webinar, can do so here.

  • USPTO News Briefs

    By Donald Zuhn –-

    USPTO Introduces New Homepage

    USPTO HomepageIn a USPTO Alert e-mail distributed today, the U.S. Patent and Trademark Office announced the release of a new homepage, which the Office indicated was "part of a larger effort to improve the public's online experience with our agency."  The Office noted that the new homepage includes features that had been requested by stakeholders and incorporates input from the Patent and Trademark Public Advisory Committees and the independent inventor community.  Two features of the new homepage highlighted by the Office are "Find It Fast" menus and a mobile-friendly version.


    USPTO Announces Start of Phase 1 of Access to Relevant Prior Art Initiative

    In a Patent Alert e-mail distributed today, the U.S. Patent and Trademark Office announced that Phase 1 of the Office's Access to Relevant Prior Art Initiative will begin on November 1.  The Access to Relevant Prior Art (RPA) Initiative is an effort by the Office to increase patent examination quality and efficiency through the development of an automated tool for USPTO examiners, which will import relevant prior art and other pertinent information from sources such as related U.S. applications, counterpart foreign applications, and International (PCT) applications into pending U.S. patent applications as early as possible in prosecution.  The Office envisions the RPA initiative as a way "to potentially reduce the burden on applicants with complying with the duty of disclosure."

    2018 Access to Relevant Prior ArtIn Phase 1 of the RPA initiative, information in the form of citations on PTO/SB/08 and PTO-892 forms from the immediate parent application will be imported into the continuing application for consideration by the Examiner.  The Office noted that Phase 1 would be limited to select art units — in particular, Art Unit 2131 in Technology Center 2100, with a wider release to Art Units 1616, 1731, 2431, 2675, 2879, 2922, 3635, and 3753 on January 1, 2019.  Applicants will receive a Notice of Imported Citations from the Office informing the applicant that an application has been included in the Initiative and listing the citations from the immediate parent application that have been imported into the application.

    Additional information regarding the RPA initiative can be found at the Office's Access to Relevant Prior Art Initiative webpage.


    USPTO Reminds Users of New Authentication System for EFS-Web and Private PAIR

    EFS-WebIn a Patent Alert e-mail distributed last week, the U.S. Patent and Trademark Office reminded users that the Office has moved to a "new, safer, and simpler" login for EFS-Web and Private PAIR.  The Office also reminded users that a new sponsorship tool will be available for registered practitioners to sponsor their support staff, who work on their behalf, in November.  The Office noted that it would "no longer support the existing public key infrastructure (PKI) certificates for two-factor authentication because the PKI authentication software vendor will no longer support the product after 2018."

    For users having problems migrating to the new authentication system, we recommend specifically following all eight steps listed under the "Migrate your PKI Certificate" tab at the Office's authentication change webpage to link a USPTO.gov account to a user's PKI certificate.  Those steps are reproduced below:

    1.  Opt-in for two-step authentication for your USPTO.gov account.
    2.  Clear your browser cache.
    3.  Close all browsers.
    4.  Go to the Migration Tool.
    5.  Sign in using your PKI digital certificate and review the Account Linking information.
    6.  Sign in using your USPTO.gov account, and confirm that both the PKI digital certificate and USPTO.gov account are verified.
    7.  Review account linking information for accuracy and provide your signature. Click on "Link accounts" to complete migration and link your PKI digital certificate to your USPTO.gov account.
    8.  Please wait 1-2 business days for your account migration to be processed by USPTO before using your USPTO.gov account to sign into EFS-Web and Private PAIR. Please note that you will need to update your bookmarks to the new EFS-Web and Private PAIR URLs for signing in with your USPTO.gov account.

    We also recommend referring to the Office's Guide for Migration (which contains some helpful screenshots) while completing the migration process.


    USPTO Extends After-Final Consideration Pilot 2.0 Program

    USPTO SealIn a Patent Alert e-mail distributed earlier this month, the U.S. Patent and Trademark Office announced that the After-Final Consideration Pilot 2.0 (AFCP 2.0) program has been extended to September 30, 2019.

    The AFCP, which was implemented in April 2012 (see "USPTO to Assess After Final Consideration Pilot Program"), modified in May 2013 (see "USPTO News Briefs"), and extended since then provides examiners with a limited amount of non-production time — three hours for utility and reissue applications — to consider responses filed following a final rejection.  The requirements for participating in the AFCP 2.0 are as follows:

    (1) a transmittal form that requests consideration under AFCP 2.0 (the Office suggests that applicants use form PTO/SB/434);
    (2) a response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect;
    (3) a statement that the applicant is willing and available to participate in any interview initiated by the examiner concerning the accompanying response (according to the Office, "willing and available" means that the applicant is able to schedule the interview within ten (10) calendar days from the date the examiner first contacts the applicant);
    (4) any necessary fees (e.g., a request filed more than three months after the mailing of a final rejection must include the appropriate fee for an extension of time under 37 C.F.R. § 1.136(a)); and
    (5) the required papers must be filed via the EFS-Web.

    Additional information regarding the AFCP 2.0 program can be found on the Office's AFCP 2.0 webpage.

  • Nobel Biocare Services AG v. Instradent USA, Inc. (Fed. Cir. 2018)

    By Joseph Herndon —

    Federal Circuit SealNobel Biocare Services AG appealed from the decision of the U.S. Patent and Trademark Office's Patent Trial and Appeal Board in an inter partes review (IPR) holding claims 1–5 and 19 of U.S. Patent No. 8,714,977 invalid based on an ABT Catalog.  Many issues were presented, and here, we review the opinion with respect to whether the ABT Catalog qualifies as a prior art printed publication under pre-AIA 35 U.S.C. § 102(b).

    This case started on October 27, 2014, by Nobel filing a complaint with the U.S. International Trade Commission (ITC) for investigation of Instradent USA, Inc.'s Drive CM dental implants as allegedly violating 19 U.S.C. § 1337 by reason of importation of an implant product that infringes the '977 patent and U.S. Patent No. 8,764,443.  The ITC found claims of the '977 patent anticipated by an ABT "Product Catalog" with the date "March 2003" on the cover.  However, later, the ITC issued a Commission Opinion which determined that Instradent had failed to show by clear and convincing evidence that the ABT Catalog is prior art under § 102(b).

    In the interim, on August 20, 2015, Instradent petitioned for IPR of claims 1–7, 9, and 13–20 of the '977 patent with invalidity challenges based on the ABT Catalog.  The Board determined that a preponderance of the evidence establishes that the ABT Catalog qualifies as a prior art printed publication under pre-AIA 35 U.S.C. § 102(b), and ultimately found the claims invalid.

    Thus, the appeal largely turns on whether the ABT Catalog is prior art under § 102(b).

    The ABT Catalog

    In or about the early 1990s, named inventor Fromovich founded Alpha-Bio Tech Ltd. ("ABT"), which sold dental implants and related goods.  He also served as ABT's CEO.  In his capacity at ABT, Fromovich conducted dentist trainings and attended industry trade shows and conferences, including the International Dental Show (IDS) Conference held in Cologne, Germany.  At the IDS Conference, dental manufacturers would showcase their products and distribute written materials describing their products.  Nobel acquired ABT and its intellectual property rights in 2008.

    The ABT Catalog included a data of March 2003 on its cover and discloses dental implant screws and other details of implants as claimed in the '977 patent.  The ABT Catalog was produced by Instradent and alleged to be prior art to the '977 patent.

    Fromovich testified about the ABT Catalog during the ITC proceedings.  When asked why the catalog says "March 2003" on the cover, Fromovich indicated that he "estimated" it was because it was created in the end of March 2003 for the IDS in Cologne, Germany.  Fromovich testified that ABT had a small booth and he attended the March 2003 IDS Conference.  According to Fromovich, the IDS Conference is "one of the biggest for distribution in Europe" with possibly a thousand attendees.  He further testified that he did not recall if he brought the ABT Catalog to the conference, but that it was "unlikely."  He explained that if he brought the ABT Catalog, it would have been a "small amount" of catalogs because it would have been a first version of a 62-page document, and ABT did not send a shipment so it would have had to fit in his luggage.

    Fromovich also testified that the ABT Catalog was used in connection with training courses and provided to attendees without requiring them to sign a confidentiality agreement.

    The parties dispute whether the ABT Catalog qualifies as a "printed publication" under pre-AIA § 102(b).  Whether a reference qualifies as a "printed publication" is a legal conclusion based on underlying factual findings, and the underlying factual findings include whether a reference was publicly accessible.  The case law indicates that a reference will be considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it.

    In addressing public accessibility of the ABT Catalog, the Board considered evidence that had been presented to the ITC, including Fromovich's testimony, and new evidence not considered by the ITC, including the declarations and deposition testimony of Yechiam Hantman and Zvi Chakir.  In March 2003, Hantman and Chakir coowned Chakir Implants, Ltd., a dental supply distributor located in Israel.  Hantman was unable to attend the conference, and he requested that Chakir collect catalogs from competitors at the 2003 IDS Conference and give them to him upon his return.  Hantman's declaration stated:  "Based upon my review of the attached materials and my specific recollections of conversations with customer [sic] in later 2002 and early 2003, and examination of the 2003 [ABT] Catalog after receiving it after the IDS trade show, I am certain that the 2003 [ABT] Catalog was publically accessible to the dental industry, including competitors, in March 2003, after the IDS show that year."

    Chakir's declaration stated that he collected catalogs and other materials from competitors, including ABT at the 2003 IDS Conference and gave the materials relating to dental implants to Mr. Hantman.

    The Federal Circuit found that substantial evidence supported the Board's finding that the ABT Catalog was publicly accessible prior to the critical date.  The Federal Circuit credited Chakir and Hantman's testimony that Chakir obtained a copy of the ABT Catalog at the March 2003 IDS Conference and that Hantman retained that copy in his records thereafter.  Hantman's declaration included excerpts of his copy of the ABT Catalog taken from his files.  The Board found that Hantman's copy of the ABT Catalog and the copy offered as prior art by Instradent in the IPR had identical pages except for some handwriting on the cover of Hantman's copy.  Nobel did not dispute this finding.

    Additionally, the ABT Catalog has the date "March 2003" on its cover.  Although the ABT Catalog's date is not dispositive of the date of public accessibility, its date is relevant evidence that supports the Board's finding of public accessibility at the March 2003 IDS Conference.

    Moreover, the Board found, and Nobel did not dispute on appeal, that the ABT Catalog is the type of document normally intended for public dissemination.  It is undisputed on appeal that the ABT Catalog is the type of document intended for public dissemination, and it bears no designations, such as "draft" or "confidential," that might suggest that it was not intended for public distribution.

    The Federal Circuit gave much weight to Chakir's testimony regarding his habitual practice in obtaining product literature, including brochures, at the IDS Conference.  Nobel's suggestion that Chakir could have obtained the ABT Catalog confidentially or under other circumstances that would not legally constitute public accessibility lacked any evidentiary basis.

    Additionally, Nobel pointed to no evidence that ABT ever distributed the ABT Catalog with an expectation that it would be kept confidential or not disseminated.

    The Federal Circuit addressed the sufficiency of the corroboration of the testimony and found the testimony of Messrs. Hantman and Chakir not only to be corroborated by each other, but also by a) the actual copy of the ABT Catalog, dated March 2003, submitted as evidence and b) Dr. Fromovich's testimony that ABT operated a booth at the March 2003 IDS conference.

    The fact that Hantman had a copy of the ABT Catalog in his files further corroborates his testimony that he obtained a copy of the same document asserted to be prior art in the IPR.

    Thus, although much of the evidence relied upon was based on testimony of biased witnesses regarding events that took place over 10-15 years ago, the Federal Circuit found no reason that the testimony was problematic.  As a result, the ABT Catalog was found to be prior art.

    Nobel Biocare Services AG v. Instradent USA, Inc. (Fed. Cir. 2018)
    Panel: Chief Judge Prost and Circuit Judges Lourie and Chen
    Opinion by Circuit Judge Lourie

  • EPO Releases Patentability Guidance for AI-based Applications

    EPO Becomes First Authority to Release Guidance Specific to Eligibility of AI/ML

    By Aaron Gin –

    EPOArtificial intelligence (AI) and machine learning (ML) are specifically addressed in new draft Guidelines for Examination (Guidance) released earlier this month from the European Patent Office (EPO).  The Guidance includes two new patentability-related subsections directed to 1) AI/ML; and 2) simulation, design or modeling.

    The Guidance first defines AI and ML as being "computational models and algorithms for classification, clustering, regression, and dimensionality reduction, [and which may include] neural networks, genetic algorithms, support vector machines, k-means, kernel regression, and discriminant analysis."  Additionally, the Guidance states that such computation models and algorithms relating to AI and ML are "per se of an abstract mathematical nature," indicating that the EPO will likely treat such algorithms as unpatentable by default.  This is further reinforced by the organizational structure of the new subsection, which appears as G(II)3.3.1 (AI and ML), falling under the mathematical methods exclusion G(II)3.3.

    Generally, under examination by the EPO, applications involving mathematical methods are excluded from patentability unless they are determined to have technical character under Art. 52(1).  In assessing whether a mathematical method possesses such technical character, a determination is made whether the invention produces a technical effect that serves a technical purpose.  A generic purpose such as "controlling a technical system" is not sufficient to confer technical character to the mathematical method.

    The Guidance specifically notes that "artificial intelligence and machine learning find applications in various fields of technology," and highlights examples of a "neural network in a heart-monitoring apparatus" and "classification of digital images, videos, audio or speech signals based on low-level features" as both possessing technical character.

    In contrast, the EPO identified the classification of text documents solely based on their textual content and classification of abstract data records without any indication of a particular technical use as not having technical purpose.  Furthermore, the EPO treats expressions such as "support vector machine", reasoning engine", or "neural network" as merely referring to abstract models that are "devoid of technical character."  Furthermore, the Guidance states that "even if [a] classification algorithm may be considered to have valuable mathematical properties," that alone is not per se a technical purpose.

    The new EPO Guidelines for Examination will go into effect on November 1, 2018, and are believed to represent the first official patent examination guidance to specifically address the eligibility of subject matter relating to AI and ML.  Going forward, it appears that such applications filed in the EPO should specifically highlight how a specific field of technology is improved by the AI-ML-related mathematical methods in order to best demonstrate technical character.