• Strafford #1Strafford will be offering a webinar entitled "Patent Eligibility and Engineered Natural Products — Overcoming 101 Challenges, Leveraging Options to Obtain IP Protection" on January 15, 2019 from 1:00 to 2:30 pm (EST).  Virginia L. Carron, Jessica L.A. Marks, and Erin M. Sommers of Finnegan Henderson Farabow Garrett & Dunner will guide patent counsel on patent eligibility issues with engineered natural products, examine the key considerations in determining patentability and review recent case law, and also address alternatives for getting IP protection for engineered natural products.  The webinar will review the following issues:

    • What are the hurdles for patent counsel to demonstrate an engineered natural product is patentable?
    • How can patent counsel meet the requirements under § 101 in patent applications for engineered natural products?
    • What steps should patent counsel take to minimize the likelihood of § 101 rejections?

    The registration fee for the webcast is $347.  Those interested in registering for the webinar, can do so here.

  • Foley & LardnerFoley & Lardner will be offering a webinar entitled "PTAB — A Year in Review" on January 10, 2019 from 1:00 to 2:00 pm (ET).  George Beck, Chase Brill, and George Quillin of Foley & Lardner LLP will discuss the year's major developments and how they may impact practice before the PTAB going forward, and address specific topics:

    • 2018 Trends and Statistics
    • SCOTUS on IPRs – Implications of SAS Institute, Inc. v. Iancu and Oil States Energy Services, LLC v. Greene’s Energy Group, LLC
    • Revisions to Standard Operating Procedures
    • Effects of Aqua Products on Amendment Practice
    • Proposal to Facilitate Amendments in AIA Challenges
    • Changes in the Claim Construction Standard Used in PTAB Proceedings
    • Sovereign Immunity: Federal Circuit Affirms PTAB Ruling that Tribal Immunity Does Not Apply to IPRs
    • Updates to the Trial Practice Guide

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

  • PLI #1Practising Law Institute (PLI) will be offering a one-hour webcast on "Patent Application Preparation in View of Recent Court Decisions: Updates and Strategies" on January 17, 2019 beginning at 3:00 pm (Eastern).  Jeffrey G. Sheldon of Cislo & Thomas LLP will provide an update on patent preparation strategies based on new developments in the law, including a discussion of the following topics:

    • Best strategies in writing applications in view of possible abstract idea and product of nature rejections
    • How to make provisional applications prior art as to third parties
    • Functional language versus product by process language – what is it?
    • Broad claims and the enablement challenge
    • Should the background portion of a patent application be skinny?
    • The potential trap of multiple embodiments in a design application
    • How many drawings in a design patent application?
    • Challenging inventorship
    • Using "and" and "or"
    • Priority claims

    The registration fee for this webcast is $299.  Those interested in registering for the webcast, can do so here.

  • By Donald Zuhn –-

    FireworksAfter reflecting upon the events of the past twelve months, Patent Docs presents its 12th annual list of top patent stories.  For 2018, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  Yesterday, we counted down stories #15 to #11, and today we count down stories #10 to #6 as we work our way towards the top five stories of 2018.  As with our other lists (2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2018" on January 16, 2019 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.

    10.  Does Unsettled § 101 Jurisprudence Preclude Attorneys' Fees

    In December, in SAP America, Inc. v. InvestPic, LLC, the Northern District of Texas awarded $679,420.46 in attorneys' fees to SAP America after the Federal Circuit affirmed an earlier decision of the District Court finding InvestPic's '291 patent invalid under 35 U.S.C. § 101.  SAP America was successful in its attempt to obtain attorney's fees based on a supposedly weak litigating position under § 101.  However, since Alice v. CLS Bank, just about any patent involving software or a business method can have its validity challenged under § 101.  Moreover, not even the federal courts have been able to crack the § 101 egg.  It is well-known that multiple federal judges have commented on the record that Alice was hard to apply in practice.  In addition, Judge Wu of the Central District of California criticized Alice for setting forth an "I know it when I see it" test.  Judge Pfaelzer, a colleague of Judge Wu, wrote that the Supreme Court's patent-eligibility cases "often confuse more than they clarify [and] appear to contradict each other on important issues."  In July, in Interval Licensing LLC v. AOL, Inc., the Federal Circuit's Judge Plager wrote that the post-Alice § 101 inquiry "renders it near impossible to know with any certainty whether the invention is or is not patent eligible."  And these are just a few examples of judicial confusion.  There are more.  For example, in September, in Gust, Inc. v. AlphaCap Ventures, LLC, the Federal Circuit ruled 2-1 that § 101 jurisprudence was too murky to be used as the basis of an attorney's fees award.  Writing in a concurring-in-part and dissenting-in-part opinion, Judge Plager concluded:

    This emperor clearly has no clothes; we need not wait for our children to tell us this.  The legitimate expectations of the innovation community, as well as basic notions of fairness and due process, compel us to address this § 101 conundrum.

    For information regarding this and other related topics, please see:

    • "SAP America, Inc. v. InvestPic, LLC (N.D. Tex. 2018)," December 10, 2018
    • "Gust, Inc. v. AlphaCap Ventures, LLC (Fed. Cir. 2018)," September 30, 2018
    • "Interval Licensing LLC v. AOL, Inc. (Fed. Cir. 2018)," July 24, 2018
    • "Cellspin Soft, Inc. v. Fitbit, Inc. (N.D. Cal. 2018)," July 12, 2018
    • "SAP America, Inc. v. InvestPic, LLC (Fed. Cir. 2018)," May 20, 2018


    9.  En Banc
    Federal Circuit: USPTO Not Entitled to Attorneys' Fees in § 145 Appeals

    In July, the Federal Circuit handed down an en banc decision in NantKwest, Inc. v. Iancu, regarding the question of whether under 35 U.S.C. § 145 an applicant must pay the U.S. Patent and Trademark Office's attorneys' fees as part of the "expenses" the statute mandates, regardless of whether the applicant won or lost the case.  The District Court had rejected the Office's argument that it was entitled to recover attorneys' fees (and other expenses), and a divided panel of the Federal Circuit reversed the District Court's decision and ordered payment of the Office's fees.  The Federal Circuit chose to review the panel's decision sua sponte, and the en banc Federal Circuit affirmed the District Court's decision, over a spirited dissent, holding that the Office was not entitled to its attorneys' fees in appeals under § 145.

    For information regarding this and other related topics, please see:

    • "NantKwest, Inc. v. Iancu (Fed. Cir. 2018) (en banc)," July 29, 2018


    8.  Supreme Court to Decide Whether Government Can File Petitions for Post-Grant Review

    In October, 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 (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 '548 patent, which claims methods, computer programs, and systems for processing undeliverable or returned mail, to the Postal Service.  Instead of licensing the '548 patent, however, 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.  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.  Both the PTAB and a majority of the Federal Circuit panel hearing the appeal found that the Postal Service satisfied the requirement that it be a "person."  The Supreme Court granted certiorari on the issue of 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.

    For information regarding this and other related topics, please see:

    • "Supreme Court to Decide if Government Can Bring AIA Proceedings," October 29, 2018


    7.  Supreme Court: PTAB Must Render Final Written Decision on All Challenged Claims

    In April, the Supreme Court reversed the judgment of the Federal Circuit in SAS Institute Inc. v. Iancu, with Justice Gorsuch (joined by the Chief Justice and Justices Kennedy, Thomas, and Alito) providing a textual explication of the inter partes review (IPR) statute in deciding that the U.S. Patent and Trademark Office was compelled to render a Final Written Decision (FWD) on all claims challenged by a petitioner in its IPR petition.  This decision overruled the Patent Office's practice that the Director (through the Patent Trial and Appeal Board) could institute an IPR on less than all challenged claims and then limit the FWD to only the instituted claims.  Just two days after the Supreme Court's decision, the U.S. Patent and Trademark Office issued Guidance regarding how the PTAB will apply the Court's mandate in SAS Institute.  In particular, the Office noted that for all pending and future-filed petitions, the Board will institute on all challenged claims so long as the petitioner has shown a reasonable likelihood of invalidating at least one of the claims, and for cases where the Board has engaged the parties in partial institution proceedings, the Board "may" issue an order "supplementing the institution decision to institute on all challenges raised in the petition."

    For information regarding this and other related topics, please see:

    • "USPTO Issues Guidance on Supreme Court Ruling in SAS v. Iancu," April 26, 2018
    • "SAS Institute Inc. v. Iancu (2018)," April 24, 2018


    6.  Supreme Court to Decide Whether AIA Changed Application of On-sale Bar

    In June, the Supreme Court granted certiorari on Helsinn Healthcare's petition to overturn the Federal Circuit's decision in Helsinn Healthcare v. Teva Pharmaceuticals that its patents were invalid by application of the on-sale bar under 35 U.S.C. 102(b).  The Question Presented in the petition was as follows:

    Whether, under the Leahy-Smith America Invents Act, an inventor's sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.

    The issue is specifically related to the question of whether the AIA changed the application of the on-sale bar.  In December, the Supreme Court heard oral argument in this case.  The Supreme Court's decision will likely land this case on our Top Stories list again next year.

    For information regarding this and other related topics, please see:

    • "Supreme Court Hears Oral Argument in Helsinn v. Teva," December 6, 2018
    • "Supreme Court Grants Certiorari in Helsinn Healthcare v. Teva Pharmaceuticals," June 26, 2018

  • By Donald Zuhn –-

    FireworksAfter reflecting upon the events of the past twelve months, Patent Docs presents its 12th annual list of top patent stories.  For 2018, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  Today, we count down stories #15 to #11, and in the coming week, we will work our way towards the top stories of 2018.  As with our other lists (2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2018" on January 16, 2019 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a handful of the most important stories on this year's list, can be found here.

    15.  USPTO Implements New Authentication System

    In October, the U.S. Patent and Trademark Office announced the implementation of a new authentication method for signing into the EFS-Web and Private PAIR, which will replace the use of PKI certificates, and which constitutes a major change in the way stakeholders interact with the USPTO's Patent Electronic Business Center (EBC).  The Office has indicated that the new method will provide users with access to the EFS-Web and Private PAIR until the full release of Patent Center, which is scheduled to replace the EFS-Web and Private PAIR, in 2020.  When announcing the new authentication system, the Office cautioned practitioners that migration to link USPTO.gov accounts to PKI certificates should be completed by the end of October (using the Office's migration tool), sponsorship of support staff should be completed by the end of November (using the Office's sponsorship tool), and that PKI certificates would be phased out on December 31, 2018.  While implementation of the new authentication system has been a fairly straightforward process for many stakeholders, many others were happy to receive an early holiday gift from the USPTO on December 21, when the Office announced that it was delaying the date on which PKI certificates would be retired.  The Office's latest word on PKI certificate retirement is that "EFS-Web and Private PAIR users will no longer be able to authenticate using PKI certificates as of February 15."

    For information regarding this and other related topics, please see:

    • "USPTO Delays PKI Certificate Termination Date," December 23, 2018
    • "USPTO Director Issues Notice on New Authentication System for EFS-Web and Private PAIR," December 3, 2018
    • "USPTO News Briefs," October 25, 2018
    • "USPTO Moving to New Authentication System for EFS-Web and Private PAIR," October 4, 2018


    14.  Federal Circuit Affirms PTAB Decision Finding No Interference in CRISPR Dispute

    CRISPR (an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats), which is part of a system for altering chromosomal sequences in situ in a cell in combination with a bacterially derived protein called Cas9, was hailed as a "Breakthrough of the Year" for 2015.  CRISPR provides a mechanism for inserting or deleting specific DNA sequences using CRISPR-associate targeting RNAs and the Cas9 RNA-guided DNA endonuclease enzyme.  Given the commercial potential of this method, patenting was an obvious concern and, as it turned out, more than one group of inventors filed patent applications on the reagents, methods, and cells produced or used to produce CRISPR modifications.  Because these applications were filed prior to March 16, 2013, the dispute regarding who was the first to invent had to be resolved via an interference.  In 2016, the USPTO declared Interference No. 106,048, naming Feng Zhang and his colleagues, the named inventor of the Broad Institute/MIT's patents, as the Junior Party, and Jennifer Doudna and her colleagues at UC/Berkeley as Senior Party.  In February of 2017, the Patent Trial and Appeal Board handed down its decision, finding no interference-in-fact between several patents and patent applications owned by The Broad Institute and applications owned by the Regents of the University of California, Berkeley.  The decision ended the interference and allowed both parties to license (and assert) their patents to (or against) any third party.  The basis for the decision was that UC's claims would not anticipate Broad's claims-in-interference because all of Broad's claims contained the affirmative limitation that the CRISPR technology be operative in eukaryotic cells, and the UC's claims were devoid of any limitation regarding the context in which CRISPR was applied.  In September, the Federal Circuit affirmed the PTAB's decision that there is no interference-in-fact between the Broad's twelve patents and one application-in-interference and the University of California/Berkeley's pending application, thereby concluding the interference between the parties.  This marks the third consecutive appearance – and perhaps the last — on our Top Stories list for the CRISPR dispute (the dispute was #19 in 2017 and #18 in 2016).

    For information regarding this and other related topics, please see:

    • "Whither CRISPR? University of California/Berkeley Granted Another CRISPR Patent," October 30, 2018
    • "Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018)," September 10, 2018
    • "The CRISPR Chronicles — Broad Institute Wins One and Loses One," January 24, 2018


    13.  Federal Circuit Defines Contours of Obviousness-type Double Patenting Doctrine

    Four years after issuing decisions in AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust and Gilead Sciences, Inc. v. Natco Pharma Ltd., the Federal Circuit again handed down opinions concerning the proper application of the judicially created doctrine of obviousness-type double patenting (OTDP).  In January, in In re Janssen Biotech, Inc., the Federal Circuit affirmed a rejection by the Patent Trial and Appeal Board of certain claims of U.S. Patent No. 6,284,471 for OTDP.  The co-assignees of the '471 patent argued on appeal that OTDP was not applicable because the safe-harbor provision of 35 U.S.C. § 121 protected the '471 patent claims.  The Federal Circuit determined, however, that the '471 patent was not entitled to safe-harbor protections because the '471 patent had issued from a CIP application (even though the co-assignees sought to re-designate the application as a divisional during a reexamination twelve years after the '471 patent issued).  In December, the Federal Circuit issued two more decisions that help define the contours of the OTDP doctrine.  In Novartis AG v. Ezra Ventures LLC, the Court addressed a narrow but important question regarding its OTDP jurisprudence:  whether a first patent filed earlier than a second patent, but that issued later, could be used to invalidate the second patent on OTDP grounds if the reason the later-expiring patent was later expiring was due to Patent Term Extension (PTE) awarded under 35 U.S.C. § 156.  The Federal Circuit affirmed the District Court's determination that OTDP does not invalidate an otherwise validly obtained PTE under § 156.  In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., the Federal Circuit was provided with an opportunity to decide whether the operation of the OTDP doctrine was the same for (a) two patents granted after the Uruguay Round Agreements Act of 1994 (URAA) changed the term of U.S. patents from 17 years from the grant date to 20 years from the earliest claimed priority date, and (b) circumstances in which one patent is subject to the pre-URAA term and the other to the post-URAA term.  In reversing the District Court, the Federal Circuit determined that its decision in Gilead Sciences, Inc. v. Natco Pharma Ltd. did not control in this instance, because the difference between how the patents were related to one another with respect to their expiration dates made a difference in how the doctrine of OTDP should be applied.  The Court noted that "because a change in patent term law should not truncate the term statutorily assigned to the pre-URAA '772 patent," the '990 patent "cannot properly be used as an OTDP reference."

    For information regarding this and other related topics, please see:

    • "Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc. (Fed. Cir. 2018)," December 11, 2018
    • "Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018)," December 9, 2018
    • "In re Janssen Biotech, Inc. (Fed. Cir. 2018)," January 29, 2018


    12.  Federal Circuit Finds Method of Treatment Claims Patent Eligible

    Although there were several interesting decisions issued in 2018 that addressed the issue of subject matter eligibility in the context of life sciences inventions (see list below), the most interesting of these decisions to most life sciences practitioners and applicants is likely one issued by the Federal Circuit in April.  In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, the Federal Circuit affirmed a District Court decision finding, inter alia, that the claims of U.S. Patent No. 8,586,610, which are directed to methods of treating a patient suffering from schizophrenia with iloperidone, were not invalid under 35 U.S.C. § 101.  Two months after that decision, the U.S. Patent and Trademark Office distributed a memorandum to the patent examining corps that addressed the impact of the Vanda decision.  The memorandum explains that in Vanda, the Federal Circuit determined that the claims at issue are "patent eligible under 35 U.S.C. § 101 because they are not 'directed to' a judicial exception" (emphasis in memorandum).  The memorandum also states that (with emphasis in memorandum):

    The USPTO's current subject matter eligibility guidance and training examples are consistent with the Federal Circuit's decision in Vanda, with the understanding that: (1) "method of treatment" claims that practically apply natural relationships should be considered patent eligible under Step 2A of the USPTO's subject matter eligibility guidance; and (2) it is not necessary for "method of treatment" claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under 35 U.S .C. § 101.  For example, claims 5 and 6 of USPTO Example 29 (Diagnosing and Treating Julitis) should be considered patent eligible under Step 2A of the USPTO's subject matter eligibility guidance in light of the Federal Circuit decision in Vanda.

    Last week, Hikma Pharmaceuticals and West-Ward Pharmaceuticals filed a Petition for a Writ of Certiorari for Supreme Court review of the Federal Circuit's decision.

    For information regarding this and other related topics, please see:

    • "Illumina, Inc. v. Ariosa Diagnostics, Inc. (N.D. Cal. 2018)," December 27, 2018
    • "A Glimmer of an Idea on an Experimental Use Exemption," November 7, 2018
    • "Roche Molecular Systems, Inc. v. Cepheid (Fed. Cir. 2018)," October 10, 2018
    • "Ex parte Galloway (PTAB 2018)," July 26, 2018
    • "Illumina, Inc. v. Natera, Inc. (N.D. Cal. 2018)," July 11, 2018
    • "USPTO Issues Memorandum on Vanda Pharmaceuticals v. West-Ward Pharmaceuticals," July 9, 2018
    • "Supreme Court Denies Certiorari Again in Patent Eligibility and Safe Harbor Cases," June 20, 2018
    • "Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd. (D. Del. 2018)," June 12, 2018
    • "Genetic Veterinary Sciences, Inc. v. LABOklin GmbH (E.D. Va. 2018)," May 22, 2018
    • "Exergen Corp. v. Kaz USA, Inc. (Fed. Cir. 2018)," March 11, 2018
    • "Ex parte Kotanko (PTAB 2018)," February 12, 2018


    11.  Supreme Court: Patentees Can Recover Lost Foreign Profits

    In June, in WesternGeco LLC v. ION Geophysical Corp., the Supreme Court determined that, based on the "focus" of 35 U.S.C. § 284 of the Patent Act (the general damages provision) when read in light of domestic infringement under 35 U.S.C. § 271(f)(2) (barring exportation of components specifically adapted for a patented invention), a patent owner could recover lost foreign profits.  The decision overruled the Federal Circuit's general practice of interpreting damages under § 271(f)(2) in the same fashion as § 271(a) (the general infringement provision, which does not allow patent owners to recover lost foreign profits).  Justice Thomas, joined by Chief Justice Roberts and Justices Kennedy, Ginsburg, Alito, Sotomayor, and Kagan, determined that despite the "presumption against extraterritoriality" in the enforcement of federal statutes, foreign lost profits due to domestic acts of infringement under § 271(f)(2) should not be categorically barred.  The majority reiterated the facts presented and that "the focus of § 284, in a case involving infringement under § 271(f)(2), is on the act of exporting components from the United States."  In this context, because the infringing act happens domestically, any lost profits (foreign or otherwise) based on that domestic infringement were merely a domestic application of § 284.  The dissent (Justices Gorsuch and Breyer) takes issue with the majority's decision permitting a patentee to be sued for damages for the use abroad of a patented article infringed under the provisions of 35 U.S.C. § 271(f)(2), arguing that "[p]ermitting damages of this sort would effectively allow U. S. patent owners to use American courts to extend their monopolies to foreign markets," and that this "would invite other countries to use their own patent laws and courts to assert control over our economy."

    For information regarding this and other related topics, please see:

    • "WesternGeco LLC v. ION Geophysical Corp. (2018)," June 24, 2018

  • By Michael Borella

    Federal Circuit SealOne final 35 U.S.C. § 101 case inched across the finish line at the end of 2018.  And while this one is not particularly remarkable substantively, its concurrence from an opinionated judge may give it an unwelcome shelf life.

    Background

    Applicant Marco Guldenaar Holding B.V. filed U.S. Patent Application No. 13/078,196.  During prosecution, the Examiner rejected a number of its claims under § 101 as allegedly being directed to patent-ineligible subject matter (the claims were also rejected as being obvious under § 103).  Guldenaar appealed to the Patent Trial and Appeal Board, but the Board affirmed the Examiner.  Guldenaar then appealed to the Federal Circuit.

    The claimed invention is related to "dice games intended to be played in gambling casinos, in which a participant attempts to achieve a particular winning combination of subsets of the dice."  Representative claim 1 recites:

    1.  A method of playing a dice game comprising:
        providing a set of dice, the set of dice comprising a first die, a second die, and a third die, wherein only a single face of the first die has a first die marking, wherein only two faces of the second die have an identical second die marking, and wherein only three faces of the third die have an identical third die marking;
        placing at least one wager on at least one of the following: that the first die marking on the first die will appear face up, that the second die marking on the second die will appear face up, that the third die marking on the third die will appear face up, or any combination thereof;
        rolling the set of dice; and
        paying a payout amount if the at least one wager occurs.

    In Alice Corp. v. CLS Bank Int'l, the Supreme Court set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under § 101.  One must first decide whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion.  But elements that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle.

    The Majority Opinion

    In its analysis, the Court leaned heavily on its holding from 2016's In re Smith.  In that case, the Court found that claims directed to a method of playing a card game failed to meet the § 101 requirements.  The Court's rationale for this decision was that the claimed invention was a method of conducting a wagering game, and thus tantamount to the methods of exchanging financial obligations found ineligible in Alice and Bilski v. Kappos.

    Guldenaar argued that the Board improperly categorized the invention as an abstract idea under an overly-broad label:  "methods of organizing human activities."  The Court sympathized with Guldenaar, even noting that "this phrase can be confusing and potentially misused, since, after all, a defined set of steps for combining particular ingredients to create a drug formulation could be categorized as a method of organizing human activity."  But the Court also observed that the Board further categorized the invention as being "rules for playing games" — a more specific type of abstract idea.

    Importantly, the Court did not hold that game rules are per se patent-ineligible.  Quoting Smith, the Court wrote that "[a]bstract ideas, including a set of rules for a game, may be patent-eligible if [the claims] contain an 'inventive concept' sufficient to 'transform' the claimed abstract idea into a patent-eligible application."  But this acknowledgment did not help Guldenaar as the Court also stated that "[t]he claims here recite the steps of placing a wager, rolling the dice, and paying a payout amount if at least one wagered outcome occurs—none of which Appellant on appeal disputes is conventional, either alone or in combination."  Thus, under the second step of Alice, "the claimed activities here are purely conventional and are insufficient to recite an inventive concept."

    Guldenaar made a further argument, that "the specifically-claimed dice that have markings on one, two, or three die faces are not conventional and their recitation in the claims amounts to significantly more than the abstract idea."  Applying printed matter doctrine, the Court rejected this notion, stating that "the printed indicia on each die are not functionally related to the substrate of the dice."

    In his final substantive argument, Guldenaar contended that "playing a dice game cannot be an abstract idea because it recites a physical game with physical steps."  The Court disagreed, noting that "the abstract idea exception does not turn solely on whether the claimed invention comprises physical versus mental steps" and that the ineligible inventions of Alice and Bilski both required actions in the physical world.  Still, the Court reiterated that "inventions in the gaming arts are not necessarily foreclosed from patent protection under § 101" while ultimately finding the claims unpatentable under § 101.

    Guldenaar also made a procedural argument, that the Board improperly treated claim 1 as representative of all claims.  The Court, however, remarked that "Appellant's appeal brief to the Board included two claim group headings under its § 101 argument:  one under which all rejected claims were discussed generally, and another under which Appellant merely quoted claim elements in dependent claims 10, 18, 24, and 26."  Invoking Rule 41.37(c)(1)(iv), the Court explained that "for an applicant to receive separate consideration by the Board for each of its appealed claims, an applicant's appeal brief must contain substantive argument beyond a mere recitation of the claim elements."  Thus, the Court found that the Board reasonably grouped all claims together with claim 1 being representative.

    Judge Mayer's Concurrence

    Judge Mayer is no stranger to the incendiary § 101 concurrence — look no further than Intellectual Ventures I v. Symantec Corp. or Ultramercial v. Hulu.  Here, once again, he pushed back against holdings of the Federal Circuit (i.e., the law) with his personal opinions about the patent-eligibility (or the lack thereof) of software.

    His opening volley set the stage:

    First, subject matter eligibility under 35 U.S.C. § 101 is a pure question of law, one that can, and should, be resolved at the earliest stages of litigation.  Second, claims directed to dice, card, and board games can never meet the section 101 threshold because they endeavor to influence human behavior rather than effect technological change.

    There are three assertions masked as two in his statement, so let's take them apart.

    Is subject matter eligibility a pure question of law?  As of today, the answer is a clear and resolute "no!"  And this is not just the opinion of a commentator, but that of the Federal Circuit in Berkheimer v. HP and a number of following decisions.  At this point, a majority of the Court's judges accept that, in practice, many § 101 inquiries require at least some baseline factual analysis.  The reason why the Court concluded so was to address the conundrum of having to determine whether elements of a claim were well-understood, routine, and conventional as a matter of law.  Making this determination almost always involves some amount of comparison of claim language to what would ordinarily be called "prior art."

    Judge Mayer quoted a number of decisions for the premise that "[e]ligibility questions mostly involve general historical observations, the sort of findings routinely made by courts deciding legal questions."  And yet, the Berkheimer case itself involved a factual dispute that was far more than a matter of historical observation — whether the claimed invention recites a combination of elements that improved the performance of a computer.  Even the Supreme Court's Bilski opinion referenced textbooks in order to establish that the claimed hedging procedure was a well-known economic practice.  It is without dispute that not all § 101 questions can be resolved by referring to mere historical facts worthy of judicial notice.  A deeper analysis is often necessary especially in the realm of complex software inventions.

    Should subject matter eligibility issues be resolved at the earliest stages of litigation?  This is a more nuanced question, and the ultimate answer is "only in some cases."  Nevertheless, Judge Mayer reiterated his concurrence in Ultramercial, stating that "[r]esolving subject matter eligibility challenges early conserves scarce judicial resources, provides a bulwark against vexatious infringement suits, and protects the public by expeditiously removing the barriers to innovation created by vague and overbroad patents."  Ignoring the unsupported assertions in the second half of this claim, the notion that being able to easily invalidate issued patents (which are presumed to be valid) during the pleadings stage and before the claims are fully construed is problematic at best.

    To make an admittedly hyperbolic analogy, if there were no Fourth Amendment right for the government to establish reasonable cause prior to arresting and charging individuals with crimes, more criminals would end up in prison.  But so would more innocent people, which is already a significant problem.  Analogously, the sharp knife of a reinvigorated § 101 has been able to eliminate, early in litigation, a number of patents that probably should not have been granted by the USPTO.  But the good patents are also taken down with the bad, and the value of many software patents has dropped due to the lingering unpredictability of the Alice test.  Given the importance of software innovation to the U.S. economy, being able to invalidate such patents based on a less than thorough application of a vague judge-made rule is a questionable practice.

    Should gaming inventions be patentable?  Like the issue of facts in the § 101 analysis, the Federal Circuit has answered this question in the positive, albeit for certain types of gaming inventions that are claimed properly.  Judge Mayer, however, opined that:

    The fault line for patent eligibility generally runs along the divide between man and machine.  Simply put, while new machines and mechanized processes can potentially be patent eligible, ideas about how to improve or influence human thought and behavior fail to pass section 101 muster.  This is why claims telling people how to mitigate settlement risk, how to hedge against risk in consumer transactions, or how to play a game of cards, are directed to non-statutory subject matter.

    This is not the law, and for good reason.  Trying to divide an invention into the technological and human parts is often an exercise in futility.  The patent-eligible invention of DDR Holdings v. Hotels.com was a hybrid web site meant to attract visitors with a familiar look and feel.  Is that a technological or business-oriented invention?  Depending how you look at it, either answer is possible.  The same could be said for self-driving car software that attempts to predict or influence the behavior of human drivers, as well as a neural-network-based machine learning system that makes photographs more pleasing to the human eye.

    Trying to answer Judge Mayer's machine versus human inquiry is, in practice, as difficult as defining the term "abstract idea" and just as unworkable.  Under his rubric, inventions that require significant technical advances can be viewed as directed to "organizing human behavior," and therefore deemed ineligible just because the invention came about with the goal of changing such behavior.  In a more rational worldview, whether the goal or the outcome of an invention involves a human element should be completely irrelevant — instead the question to ask is whether the invention involves a focused and significant advance over the state of the art.

    In sum, Judge Mayer doesn't like software patents.  But his broad, sweeping language should not be mistaken for the current state of § 101 affairs, nor should it be used to influence our thought or behavior regarding such affairs.

    In re Marco Guldenaar Holding B.V. (Fed. Cir. 2018)
    Panel: Circuit Judges Chen, Mayer, and Bryson
    Opinion by Circuit Judge Chen; concurring opinion by Circuit Judge Mayer

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "International Post Grant Practice: Strategic Considerations Before the USPTO, EPO and CNIPA" on January 3, 2019 from 12:00 to 1:00 pm (ET).  Stephen Bauer of Medtronic, James Denness of Abel & Imray, and Toby Mak of Tee & Howe Intellectual Property Attorneys will highlight the differences and similarities in post-grant practice in front of three leading patent authorities, as well as strategies that can lead to global settlement in licensing negotiations, and also review effective defensive strategies for patent owners, both in patent drafting and in litigation.  The panel will discuss:

    • Considerations in deciding where to bring an overseas challenge ‒ and in what order proceedings should be brought
    • Monitoring competitors’ patent issuance, internal product launch considerations, and the desire for freedom to operate
    • The potential ramifications of translation errors in Chinese patents
    • The impact of shrinking patent pendency at the EPO
    • Specific techniques for strengthening patents against post-grant challenges in each jurisdiction

    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.

  • By Kevin E. Noonan

    District Court for the Northern District of CaliforniaU.S. District Court Judge Susan Illston stuck again on Christmas Eve, giving the biotech patent community a rhetorical lump of coal in their stocking by invalidating on summary judgment claims directed to methods for isolating cell-free fetal DNA from maternal DNA on the grounds that they are not patent-eligible under 35 U.S.C. § 101.  The author of the Ariosa v. Sequenom decision a few years ago, Judge Illston has rarely seen a patent she likes (or is not willing to invalidate), and the Supreme Court and Federal Circuit's recent § 101 jurisprudence has given district court judges the judicial discretion to invalidate patents based on their subjective determination of their eligibility.

    The patents at issue, U.S. Patent Nos. 9,580,751 and 9,738,931, recite the following representative independent claims:

    The '751 patent:

    1.  A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:
        (a) extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;
        (b) producing a fraction of the DNA extracted in (a) by:
            (i) size discrimination of extracellular circulatory DNA fragments, and
            (ii) selectively removing the DNA fragments greater than approximately 500 base pairs,
            wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and
        (c) analyzing a genetic locus in the fraction of DNA produced in (b).

    The '931 patent:

    1.  A method, comprising:
        (a) extracting DNA comprising maternal and fetal DNA fragments from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female;
        (b) producing a fraction of the DNA extracted in (a) by:
            (i) size discrimination of extracellular circulatory fetal and maternal DNA fragments, and
            (ii) selectively removing the DNA fragments greater than approximately 300 base pairs,
            wherein the DNA fraction after (b) comprises extracellular circulatory fetal and maternal DNA fragments of approximately 300 base pairs and less and a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA fragments; and
        (c) analyzing DNA fragments in the fraction of DNA produced in (b).

    Both patents were subjected to rejection under § 101 and allowed upon application of U.S. Patent and Trademark Office Guidance for applying Supreme Court and Federal Circuit law to the question of subject matter eligibility relating to natural phenomena and laws of nature.

    The Court, as has become district courts' wont, rendered summary judgment without a Markman hearing construing the claims, and in its opinion characterized the claimed methods for both patents as being directed to prenatal detection, fairly based on steps (c) in each patent's claims.

    After setting forth the legal standards the District Court addressed the two prongs of the Alice/Mayo analysis for patent eligibility:  whether the claims were "directed to" ineligible subject matter and whether they recite an inventive concept.  Regarding the first, "directed to" prong, the opinion says that these claims are analogous to the claims invalidated under Federal Circuit precedent in Genetic Techs Ltd. v. Merial and, of course, Ariosa v. Sequenom.  The opinion recites without contradiction Ariosa's contention that "the claimed method begins with a sample of cell-free DNA and ends with an analysis of it," which is not exactly true; in these claims the claim starts with a sample of cell-free maternal blood plasma containing cell-free fetal DNA and ends with an isolate of cell-free fetal DNA.  The opinion cites a declaration, and prosecution history challenging changes in purity with change in structure.  "Changing the ratio of two natural products in a mixture and analyzing one of those products does not impact whether an invention is directed towards a natural phenomenon," according to the Court's opinion.  Further, the opinion states that "[b]oth patents claim results from a test of naturally occurring fetal DNA and do not transform the naturally occurring product into something new."  Finally with regard to this prong, the Court rejected Illumina's assertion of the Federal Circuit's Rapid Litigation Management Ltd. v. Cellzdirect, Inc. decision, based on the distinction that frozen liver cells, the subject matter of the claims in Cellzdirect, do not occur in nature.

    Regarding inventive concept, the Court relied on the recent Federal Circuit decision in Roche Molecular Systems v. Cepheid to distinguish the Cellzdirect precedent.  The Court found the claims not inventive, because the method steps (extraction, size production, selective removal), taken in the abstract, are routine, conventional, and well understood.  In doing so, the Court rejected the argument that applying these methods to previously unknown cell-free fetal DNA in maternal blood is not "routine, conventional, and well-understood," with some no doubt unintended irony relying on the statement from Diamond v. Diehr that "[t]he novelty of any element or steps in a process, or even the process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter."  Of course, that statement is not entirely apposite to the situation before the Court, and was made before Justice Breyer and a unanimous Court endorsed mixing novelty and obviousness considerations into the subject matter eligibility calculus in Mayo.

    There was a time when patent practitioners could take some solace that the Federal Circuit would apprehend the threats to innovation that decisions such as this one pose and would act to limit their scope if not apply appropriate correction.  That time, of course, is long past and it can only be hoped that recent chinks in the Federal Circuit's subject matter eligibility façade suggest members of the Court are receptive to reconsidering how Supreme Court subject matter eligibility decisions have been interpreted.  This remains, of course, a hot potato issue, and whether whatever panel of the Court hears the case hews to either the Court's Cellzdirect or its Cepheid precedent is frankly a matter of chance.  That biotech patenting has reached this point, particularly in view of the importance of innovation for the U.S. economy and its citizens' well-being, is disheartening.  As the kids would say on social media, SMH.

    Illumina, Inc. v. Ariosa Diagnostics, Inc. (N.D. Cal. 2018)
    Order Granting Defendants' Motion for Summary Judgment by District Judge Illston

  • By Donald Zuhn

    S.D. TexEarlier this month, in Gensetix, Inc. v. Baylor College of Medicine, District Judge Andrew S. Hanen of the U.S. District Court for the Southern District of Texas issued an Order granting a Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(1) filed by Involuntary Plaintiff The Board of Regents of the University of Texas ("UT"), as well as related portions of a Supplemental Reply in Support of a Motion to Dismiss Gensetix's First Amended Complaint filed by Defendant Baylor College of Medicine ("BCM") and a Motion to Dismiss Gensetix's First Amended Complaint filed by Defendant Diakonos Research, Ltd. ("Diakonos").  The District Court also declined to exercise supplemental jurisdiction over Gensetix's state law claims and therefore dismissed the case.

    The dispute between the parties arose when Plaintiff Gensetix, Inc. filed suit against Defendants BCM, Diakonos, and Dr. William K. Decker, asserting that Defendants infringed U.S. Patent Nos. 8,728,806 and 9,333,248, which Gensetix exclusively licensed from UT.  The '806 and '248 patents are directed to methods of modifying a patient's immune system to kill cancer cells.  Dr. Decker developed the claimed methods during his tenure at The University of Texas MD Anderson Cancer Center.  In its complaint, Gensetix asserted that although Dr. Decker retained no rights in the asserted patents, he continued to practice the claimed methods after moving to BCM.  In its complaint, Gensetix named UT as an involuntary plaintiff.  UT responded by filing a Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(1), asserting immunity from suit under the Eleventh Amendment as an arm of the State of Texas, and contending that such immunity deprived the District Court of subject matter jurisdiction.  Gensetix countered that Eleventh Amendment sovereign immunity did not apply in this case because no claims were asserted against UT.

    In deciding whether the Eleventh Amendment deprived the District Court of subject matter jurisdiction, the Court noted that the issue in the case was more accurately whether the Eleventh Amendment prevented UT from being joined as an involuntary plaintiff in a patent suit.  Gensetix argued that the Eleventh Amendment did not bar this type of joinder, citing Independent Wireless Telegraph Co. v. Radio Corporation of America, 269 U.S. 459 (1926), for the proposition that "if there is no other way of securing justice to the exclusive licensee," the licensee may join the licensor "as a coplaintiff without his consent."  Gensetix also cited Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), for the proposition that "the Eleventh Amendment applies to suits 'against' a state, not suits by a state," arguing that where a suit does not involve any actual claims against the state, the state is not in the position of a defendant.  The District Court, however, indicated that "Independent Wireless and Regents are readily distinguishable from the case at hand," noting that "[t]he Court in Independent Wireless did not contemplate the coercive joinder of a sovereign" because the patent owner was a private company and could not assert the Eleventh Amendment, and pointing out that in Regents, "UC had agreed to participate in the suit in the first place."  Thus, the District Court concluded that "Independent Wireless and Regents are not as instructive as Plaintiff contends."  Instead, the Court agreed with UT and the Defendants that sovereign immunity was applicable to the coercive joinder analysis in this case, and found that joinder of UT as an involuntary plaintiff was barred by the Eleventh Amendment.  The Court noted that "[a]lthough there are currently no claims against UT, requiring joinder would, in effect, force UT to pursue claims against its will," and because "UT did not waive its immunity, initiate this suit, or agree to participate in this litigation . . . the Eleventh Amendment prohibits involuntary joinder."

    Finding that the Eleventh Amendment prevented UT's joinder, the District Court next considered whether Gensetix independently had standing to pursue the infringement claims.  With respect to this issue, the Court noted that when a patent owner transfers all "substantial rights" in the patents-in-suit to an assignee or licensee, the transfer is "tantamount to an assignment of those patents to the exclusive licensee, conferring standing to sue solely on the licensee," citing Alfred E. Mann Found.for Sci. Research v. Cochlear Corp., 604 F.3d 1354, 1358-59 (citing Vaupel Textilmaschinen KG v. Meccanica Euro Italia SPA, 944 F.2d 870, 873-74 (Fed. Cir. 1991)).  Although Gensetix argued that it held all substantial rights to the patents, the Court noted that in the license agreement between Gensetix and UT, UT retained a broad right to sue and control litigation.  The Court therefore concluded that the license agreement failed to confer standing to Gensetix.  The Court also noted that:

    UT retained the right to publish general findings, use licensed subject matter for research, teaching, or other academic purposes, and transfer rights to other research institutions for non-commercial research use.  UT may practice and license the patent for non-commercial use; accordingly, while there are some limits on UT's right to license the patent, it still retains the right to do so.  Thus, Gensetix's right to license the patent is not truly "exclusive."

    After weighing all the factors, the District Court concluded that:

    While Gensetix has the right to practice, it does not have the unfettered right to exclude others.  The right to practice is not substantial enough to allow Gensetix to bring suit in its name alone.  Accordingly, Gensetix does not have standing to sue for infringement of the '806 and '248 patents without joining UT as a party [citations omitted].

    The District Court also determined that joinder of UT was necessary under Fed. R. Civ. P. 19(a)(1), finding that patent owners who grant exclusive licenses and retain substantial rights in the patent are necessary parties to infringement actions brought by their licensees.  The Court noted that "[w]ithout UT, Defendants in this case could be subject to multiple suits," pointing out that "were this case to proceed without UT, UT would risk losing the '806 and '248 patents without the opportunity to defend its rights."  However, in this case, UT did not waive its sovereign immunity.  The Court therefore concluded that "where UT retains substantial rights in the patents-in-suit, refuses to join voluntarily, but retains sovereign immunity, UT may not be joined as an involuntary plaintiff."  The Court also noted that:

    [W]here the substantial rights holder—here, UT—refuses to sue to protect its own patent, it is not proper for the Court to step in and effectuate a rescue.  While the result may be harsh, it is an inherent risk for anyone who chooses to contract with a sovereign entity.

    The District Court concluded by declining to exercise supplemental jurisdiction over Gensetix's state law claims, finding that that "judicial economy, convenience and fairness to litigants" would not be served by keeping the remaining causes of action in federal court.  The Court therefore determined that the Eleventh Amendment barred UT's joinder as an involuntary plaintiff; granted UT's Motion to Dismiss, the related portion of BCM's Supplemental Reply in Support of its Motion to Dismiss, and the related portion of Diakonos' Motion to Dismiss; and dismissed the case.

    Gensetix, Inc. v. Baylor College of Medicine (S.D. Tex. 2018)
    Memorandum and Order by District Judge Hanen