• CalendarMay 1, 2018 – "Patent Inventorship: Best Practices for Determination and Correction — Distinguishing Between Inventor and Contributor; Navigating Joint Inventorship, Disclosure of Ownership, Real Party in Interest" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 2, 2018 – "Recent Developments in Double Patenting: ODP Challenges and Considerations" (The Knowledge Group) – 12:00 to 1:30 pm (ET)

    May 2, 2018 – "The Supreme Court Decided Oil States & SAS Institute: Now What?" (Federal Circuit Bar Association) – 3:00 pm to 4:00 pm (EST)

    May 3, 2018 – "Patent Ownership Rights: Structuring Assignment and Employment Contracts — Key Provisions, Implications for Litigation, Recent Court Treatment" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 3, 2017 – "The Very Essence of Romance is Uncertainty" (Intellectual Property Owners Association European Practice Committee) – Amsterdam, Netherlands

    May 3, 2018 – "The Evolving State of Sovereign Immunity Before the Patent Trial and Appeal Board" (Technology Transfer Tactics) – 1:00 to 2:00 pm (ET)

    May 8, 2018 – Symposium on Intellectual Property (George Washington University Law School, Pillsbury, NERA Economic Consulting, and Mayer Brown) – Washington, DC

    May 8, 2018 – "Intellectual Property Valuation and Damages: Nuts and Bolts in 2018" (The Knowledge Group) – 12:00 to 1:30 pm (ET)

    May 9, 2018 – "Supplemental Examination Requests: Benefits and Limitations, Strategic Use — Assessing Enforceability of Patent Portfolios, Evaluating the High Burden" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 8-10, 2018 – Patent Fundamentals Bootcamp 2018: An Introduction to Patent Drafting, Prosecution, and Litigation (Practising Law Institute) – Chicago, IL

    May 10, 2018 – "Will the Supreme Court Step in Again in Helsinn v. Teva? Does a Sale of Confidential Materials Trigger the On-Sale Bar?" (Federal Circuit Bar Association) – 3:00 pm to 4:00 pm (EST)

    May 10, 2018 – European Patent Strategies (Intellectual Property Law Association of Chicago Corporate Committee and Weickmann & Weickmann) – 5:00 pm to 6:05 pm (CT), Chicago, IL

    June 13-15, 2018 – Patent Fundamentals Bootcamp 2018: An Introduction to Patent Drafting, Prosecution, and Litigation (Practising Law Institute) – New York, NY

    June 25-27, 2018 – Summit on Biosimilars (American Conference Institute) – New York, NY

    July 18-20, 2018 – Patent Fundamentals Bootcamp 2018: An Introduction to Patent Drafting, Prosecution, and Litigation (Practising Law Institute) – San Francisco, CA

  • Federal Circuit Bar AssociationThe Federal Circuit Bar Association (FCBA) will be offering a webcast entitled "The Supreme Court Decided Oil States & SAS Institute: Now What?" on May 2, 2018 from 3:00 pm to 4:00 pm (EST).  Emily Johnson of Amgen, Inc. will moderate a panel consisting of Allyson Ho of Morgan Lewis & Bockius LLP, Christopher Suarez of Williams & Connolly LLP, Gregory Castanias of Jones Day, and Russell Cass of Clark Hill PLC.  The panel will discuss the Supreme Court's decisions in Oil States and SAS Institute, including their holdings and the issues left for another day, potential implications for patent owners and petitioners involved in IPR proceedings, anticipated changes to PTAB adjudication of IPR challenges, likely impact on district court litigations and appeals to the Federal Circuit, the next expected constitutional challenges to IPR proceedings, and potential consequences of labeling patent grants as "public rights" and "public franchises."

    The webinar is complimentary for FCBA members and $50 (government/academic/retired) or $125 (private practitioner) for non-members.  Those interested in registering for the webcast, can do so here.

  • Federal Circuit Bar AssociationThe Federal Circuit Bar Association (FCBA) will be offering a webcast entitled "Will the Supreme Court Step in Again in Helsinn v. Teva? Does a Sale of Confidential Materials Trigger the On-Sale Bar?" on May 10, 2018 from 3:00 pm to 4:00 pm (EST).  Mark Freeman, Appellate Staff, Civil Division, U.S. Department of Justice will moderate a panel consisting of Joe Matal of the U.S. Patent & Trademark Office, Amy Saharia of Williams & Connolly LLP, and Dmitry Karshtedt of the George Washington University School of Law.  The panel will discuss the prospects for Supreme Court review in Helsinn v. Teva, in which the Federal Circuit construed the amended on-sale bar of the Leahy-Smith America Invents Act, determining that Congress did not alter the scope of the bar, and the ramifications of each possible outcome for future users of the first-to-file patent system.

    The webinar is complimentary for FCBA members and $50 (government/academic/retired) or $125 (private practitioner) for non-members.  Those interested in registering for the webcast, can do so here.

  • IPLACThe Intellectual Property Law Association of Chicago (IPLAC) Corporate Committee and Weickmann & Weickmann will be offering a panel discussion on European Patent Strategies by Alfred Keyack, EPO Attaché to the United States, and Dr. Frank Feller, European Patent Attorney on May 10, 2018 from 5:00 pm to 6:05 pm (CT) at SRAM, LLC in Chicago, IL.  George Jonas, Downstream Managing Counsel, Global Patents and Technology, BP America, Inc. will moderate the discussion.

    There is no registration fee for event, but attendees must register in advance.  Those interested in registering for event can do so here.

  • By Kevin E. Noonan

    USPTO SealWell, that didn't take long.  The U.S. Patent and Trademark Office issued Guidance today, just two days after the Supreme Court decision in SAS Institute Inc. v. Iancu came down, regarding how the Patent Trial and Appeal Board (PTAB) will apply the Court's mandate in that inter partes review (IPR) decisions are all or nothing with respect to challenged claims ("Guidance on the Impact of SAS on AIA Trial Proceedings").

    The Guidance is simple:  going forward (i.e., 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.  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."  In such cases the Board also has discretion to take action "permitting additional time, briefing, discovery, and/or oral argument."  Examples included in the Guidance include granting additional time for the Patent Owner Response or, if the statutory twelve-month time is close to expiry, taking advantage of the additional six months provided by the statute for extraordinary cases.  The Guidance stresses however that such decisions will be made on a case-by-case basis.

    The Petitioner and Patent Owner responses to such a supplementation order are specified to include a "meet-and-confer" discussion between the parties on whether additional briefing, time, etc. is needed; the Guidance notes that while the Board may (i.e., has the discretion to) act sua sponte, there may be no accommodation of the parties unless they request it.  And of course the parties can affirmatively waive any changes to the briefing schedule or timing, the Guidance suggests.  The result of such a meet-and-confer will be a conference with the Board, which will resolve any failure to agree between the parties.  The Final Written Decision arising from such cases will contain a decision on all challenged claims, both as originally instituted and added through amendment of the institution decision.

    The Guidance directs parties to contact the panel (only for case-specific questions) or to submit written questions to the Trials@uspto.gov mailbox.

    The Guidance closes by reminding the public that the Office fortuitously scheduled a "Chat with the Chief" webinar on Monday, April 30 at noon EDT, where Chief Patent Judge David Ruschke will discuss the Guidance.

  • By Kevin E. Noonan

    CockroachesPerhaps somewhat ironically, a group of Chinese researchers* recently published a report on the genome of the American cockroach (Periplaneta americana), entitled "The genomic and functional landscapes of developmental plasticity in the American cockroach" in Nature Communications.  These researchers,** applying a variety of modern genomic analysis techniques, elucidated aspects of the animal's genomic DNA having implications for its range, behavior, and ecology.

    The report details genetic assessment of the P. americana genome, comprising 3.38Gb; this is the second largest genome to locusts (Locusta migratoria) among insect species.  P. americana was introduced into Americas from Africa in 16th century and is related to other cockroach species as well as two termite species.  Using a consensus gene set, the researcher found expansion of genes associated with environmental adaptation, including chemoreception and detoxification.  "Multiple pathways" that regulate metamorphic development well-conserved, and 20-hydroxyecdysone, juvenile hormone, insulin, and decapentaplegic signals are involved in regulating developmental and behavioral plasticity.

    The report details the results produced from more than 1 terrabasepairs from 3 individuals, assembled de novo to 295-fold coverage; for comparison, samples from the Australian cockroach (P. australasiae) and the smoky brown cockroach (P. fuliginosa) were sequenced to forty-fold coverage.  About 60% of genomic sequences comprise repetitive elements, but otherwise the genomic DNA composition found for this species is typical for species in Order Blattodea (which comprises more than 4,000 species of cockroaches and more than 3,000 species of termites).  The American cockroach genome comprises 21,336 protein-coding genes, 95% of which were detected to be expressed; 90% of these genes are inherited in common with other species in this Order, with 84% found in related cockroach species and 82% in the dampwood termite.  13,555 of these are genes are termed "multicopy universal" genes.  Median intron length (3 kp) found in the cockroach genes is half the average size in locust genes but larger than in other insect species.  A total of 17.5 Gb transcriptome sequencing data were generated from three independent libraries, with inserts of 1–2 Kb, 2–3 Kb, and 3–6 Kb, for the messenger RNA pool of all stages of cockroach development.

    Using this data the researchers compared 12 insect species for "gene repertories" and found 479 orthologs specific for species in Order Blattodea in ~1,000 cockroach genes; the American and German cockroaches (B. germanica) encode largest gene sets, but showed fewer species-specific genes than other insect species.  In more detail analyses, 2,000 single copy universal genes were identified, 538 chosen to establish phylogenetic relationships between the 12 insect species.  Comparisons with other cockroach species showed that P. americana, P. fuliginosa and P. australasiae, shared about 88% amino acid identity between orthologous proteins.  P. americana shares only 75% sequence identity with B. germanica, which was a lesser degree of relatedness than was found between P. americana and two termite species:  Z. nevadensis (which shares 79% sequence identity) and M. natalensis (which shares 80% sequence).  Among 7,640 common orthologs between these species, approximately two-thirds of the American cockroach genes are more closely related to the termite genes in sequence identity, while only one-third being more closely related to the German cockroach.

    The genes shared between the American cockroach and termite species were "significantly over-represented in 29 pathways, including a number of classic functional components in insects, such as development, nutrition, and immunity."  In contrast, genes shared between the American cockroach and the German cockroach were "significantly enriched" in only 6 such pathways, two of which are related to signal transduction.

    With regard to the genes analyzed to identify those genes important to evolution of the cockroach, the researchers started from the presumption that "[a]daptation to host and environment is mainly mediated by chemical communication and subsequent abilities to tolerate chemical and biological factors, such as toxins or pathogens."  These were genes from families involved in chemoreception, detoxification, and immunity.  For chemoreception genes, a total of 154 olfactory receptor genes (ORs) were found in the Pamericana genome, while other Blattodean species were found with only half as many ORs.  The PAmericana genome comprises 522 gustatory receptor genes (GRs), which represents the greatest expansion of GRs in the insect species reported to date.  Interestingly, 329 of these GRs formed a specific clade in the phylogeny and were annotated as potential bitter receptors.  The ionotropic glutamate receptor (IR) gene family also has experienced a substantial expansion in the P. americana genome, in which were found a total of 640 candidate IRs (Fig. 2c), much more than that in the termite genome (148 in Z. nevadensis; Fig. 2a) (see Figure 2).

    Other genes arising from this analysis include odorant binding protein (OBP) genes, the number of OBPs in Blattodean species (with the most in P. americana) being dramatically reduced compared to Drosophila and other insects (Fig. 2a), suggesting to these researchers that the transport of odorant molecules may be functionally conserved in cockroaches.

    With regard to genes involved with detoxification, 178 cytochrome P450s, 90 carboxyl/choline esterases, 39 glutathione transferases, and 115 ATP-binding cassette transporters were detect in the P. Americana genome.  The P450 genes showed the greatest expansion in the American cockroach, compared with other Blattodean species.  Phylogenetic analysis of P450s across Blattodean species could be collected into four major clans, the CYP2, the CYP3, the CYP4, and the mitochondrial clade (Fig. 2d).  Most P450 genes in P. americana clustered with CYP3 (79/178 genes) and CYP4 (62/178 genes) lineages (Fig. 2d).  The researchers speculated that specific expansion of these P450 genes improved insecticide resistance in the American cockroach, which clearly has implications for improved survival.

    Genes involved in immunity comprise "innate" immunity genes in the Imd, Toll, and Janus kinase-signal transducer and activator of transcription (JAK-STAT) gene pathways.  Compared with other insects, many of these genes, particularly in the Toll pathway, were found to have been extensively expanded.  In addition, Gram-negative binding proteins (GNBPs), pattern recognition proteins responsible for the detection of pathogens and activation of the Toll pathway, were found to be expanded, there being 12 GNBP1-like and 2 GNBP3-like genes in the American cockroach genome, which is more than in any of those insect species examined (for example, there are a maximum of 6 GNBPs in Z. nevadensis).  Similarly, Toll protein genes were expanded in American cockroach DNA (14 Toll protein genes) compared, for example, with the Drosophila genome (which encodes 9 Toll protein genes).  Eleven antimicrobial protein (AMP) genes were detected in the P. americana genome, including defensins, termicins, attacin, drosomycin, Pro-rich peptide (Paprp-1), and anti-fungus peptide (AFP).  In functional testing, these researchers found strong antimicrobial activity after injection with Escherichia coli (Gram-negative bacterium), moderate antimicrobial activity with Staphylococcus aureus (Gram-positive bacterium), and weak antimicrobial activity with Candida albicans (fungi), consistent with the cockroach habitat including decaying animal matter and other offal.

    What the researchers termed "crucial biosynthesis and signaling pathways for regulating insect development" were "substantially expanded" in the American cockroach genome, including insulin-like peptide and genes involved in juvenile hormone biosynthesis and metabolism, and the cuticle protein family also appeared to be one of the most expanded gene families in P. americana.  These results are consistent with the increased size of the American cockroach, which has the largest size (up to 53 mm in body length, the frequency of molting (6-14 times), and the longest life cycle (700 days).  The researchers also report that signaling pathways thought to be involved in wound healing and tissue repair in insects (Drosophila) and vertebrates, were expanded in certain pathways (including the Grainy head (GRH), Wingless (Wg), and Notch pathways), which may also contribute to the hardiness of these insects.

    In addition to the intrinsic interest of these results for understanding insect relatedness, ecology, and behavior, the results reported in this paper elucidate for the first time specific genetic correlates to traits that have permitted the American cockroach to thrive in disadvantageous environments.  To the extent that the common perception of this insect, that it can (and will) outlive the human species and even a nuclear holocaust, has any validity, this capacity relies at least in part on the genetic characteristics set forth in this paper.  There is something to be learned, about evolution, survival, and life on this planet, from these beasts.

    *Sheng Li, Shiming Zhu, Qiangqiang Jia, Dongwei Yuan, Chonghua Ren, Kang Li, Suning Liu, Yingying Cui, Haigang Zhao, Yanghui Cao, Gangqi Fang, Daqi Li, Xiaoming Zhao, Jianzhen Zhang, Qiaoyun Yue, Yongliang Fan, Xiaoqiang Yu, Qili Feng & Shuai Zhan

    **From Guangzhou Key Laboratory of Insect Development Regulation and Application Research, Institute of Insect Science and Technology & School of Life Sciences, South China Normal University, Guangzhou; CAS Key Laboratory of Insect Developmental and Evolutionary Biology, CAS Center for Excellence in Molecular Plant Sciences, Institute of Plant Physiology and Ecology, Chinese Academy of Sciences, Shanghai; the University of Chinese Academy of Sciences, Beijing; the Research Institute of Applied Biology, Shanxi University, Taiyuan; Zhongshan Entry-Exit Inspection and Quarantine Bureau Technology Center, Zhongshan; and State Key Laboratory of Crop Stress Biology for Arid Areas and Key Laboratory of Integrated Pest Management on the Loess Plateau of Ministry of Agriculture, Northwest A&F University, Yangling

  • By Andrew Williams

    Supreme Court Building #2Earlier today, the Supreme Court held in Oil States Energy Services, LLC v. Greene's Energy Group, LLC that inter partes review proceedings do not violate Article III or the Seventh Amendment of the Constitution.  Justice Thomas, writing for the 7-2 majority, explained that a grant of a patent is a matter involving a public right.  Moreover, because IPR proceedings involve the same basic matter as the grant of a patent, they also fall within the public rights doctrine.  As a result, the Constitution does not prohibit the Patent Office from resolving issues of validity post issuance outside of an Article III Court.  Important to the analysis was the lack of distinction between IPR proceedings and the initial grant of the patent because "[p]atent claims are granted subject to the qualifications that the PTO has 'the authority to reexamine – and perhaps cancel – a patent claim' in an inter partes review."  Justice Breyer wrote a concurrence that was joined by Justices Ginsberg and Sotomayor.  Even though he joined the Court's opinion in full, he wanted to stress that the decision should not be read as stating that matters involving private rights could never be adjudicated outside of Article III courts.  Justice Gorsuch dissented, and was joined by the Chief Justice.  In his dissent, Justice Gorsuch explained that the history of the patent system and the prior case law required the finding that patents are private rights, and therefore must be adjudicated in Article III courts.

    We have previously explained the background of the Oil States case.  Interestingly, this case was appealed from a Federal Circuit Rule 36 affirmance.  Nevertheless, the Federal Circuit had previously considered the issue of the constitutionality of IPRs in MCM Portfolio LLC v. Hewlett-Packard Co.  In that case, a three-judge panel concluded that because patents are public rights and "the grant of a patent is primarily a public concern," Congress was able to create administrative procedures for assessing their validity.  This case was consistent with the Federal Circuit's decision in Patlex Corp. v. Mossinghoff, in which the Court had determined that ex parte reexaminations did not violate Article III of the constitution.  Nevertheless, not all Federal Circuit judges appeared to agree with this conclusion.  In a dissent to the denial of a petition for en banc hearing in Cascades Projection LLC v. Epson America, Inc., Judge Reyna explained that Supreme Court precedent was clear that only Article III courts had the authority to set aside or annul a patent right.

    One of the cases that Judge Reyna cited, McCormick Harvesting Machine v. Aultman, was discussed at length in today's Supreme Court decision by both the majority and the dissent.  And as we predicted, both sides pointed to McCormick Harvesting as either supporting their opinion (or at least not being in conflict with it).  Justice Gorsuch pointed to the broad sweeping language from that case that stated "[t]he only authority competent to set a patent aside, or to annul it, or to correct it for any reason whatever, is vested in the courts of the United States, and not in the department which issued the patent."  However, the majority correctly pointed out that this is "best read as a description of the statutory scheme that existed at that time," and did not address whether Congress had authority to establish an entirely different scheme.  In fact, before the 1870 change to the patent statute discussed in that case, Congress did provide examiners with absolute discretion to cancel any reintroduced original claim in a reissue proceeding.  It was the fact that Congress withdrew this grant of authority before McCormick Harvesting that made the Patent Office's cancellation of original claims in reissue proceedings a violation of due process and an invasion on the then-exclusive jurisdiction of the judicial branch by the executive.

    The Court did stress, however, that its holding was limited to the question of the constitutionality of IPRs only.  For example, the Court pointed out that "Oil States [did] not challenge the retroactive application of inter partes review, even though that procedure was not in place when its patent issued."  This will almost certainly lead to continued constitutional challenges for patents that issued prior to the enactment of the AIA.  In addition, the Court noted that it was not determining whether IPR proceedings raise due process concerns, which is interesting in view of the questioning about expanded panels during oral argument.  Finally, the Court stressed that the holding should not be misconstrued to suggest that other constitutional challenges could not be made, for example challenges related to the Due Process Clause or the Takings Clause.  These limitations to the holding virtually ensure that there will be continued challenges to particular IPR practices adopted by the PTAB.

    A potential silver lining for Patent Owners is that the patent system appears to have a new friend in Justice Gorsuch.  His dissent did an admirable job in pointing out the policy reasons that supported his conclusion.  He stressed the time and cost of not only inventing something truly novel, but the additional resources necessary to apply for and obtain a patent.  And this fails to capture any investment made to commercialize the patent in reliance of the patent rights.  But as Justice Gorsuch put it, "what happens if someone later emerges from the woodwork, arguing that it was all a mistake and your patent should be canceled?"  Of course, if true, the patent holder would not have been deserving of the patent in the first place.  However, should "a political appointee and his administrative agents, instead of an independent judge, resolve the dispute?"  This was the crux of his problem with the Court's decision.  As Justice Gorsuch pointed out, the Director of the Patent Office serves at the pleasure of the President, and he supervises and pays the Board.  The Director can select the APJs that will hear a case, determine how many will be on a particular panel, and even add more members to the panel if the decision is not to his liking.  This problem can be solved by allowing Article III courts to be the only venue to resolve validity disputes of issued patents.  As Justice Gorsuch put it, "when an independent Judiciary gives ground to bureaucrats in the adjudication of cases, the losers will often prove the unpopular and vulnerable."  Instead of the judicial independence, we are at the risk of "armies of lobbyists and lawyers [that will] influence (and even capture) politically accountable bureaucracies."  We can only hope that this doomsday scenario does not come to pass (and hope that the Federal Circuit will be a reliable backstop for any true abuse of power).  But it will be interesting to see if Justice Gorsuch will continue to champion the patent system in future case (or whether it was just his distrust of the administrative state that brought him to the defense of patents in this case).

    Oil States Energy Services, LLC. v. Greene's Energy Group, LLC (2018)
    Opinion of the Court by Justice Thomas, joined by Justices Kennedy, Ginsburg, Breyer, Alito, Sotomayor, and Kagan; concurring opinion by Justice Breyer, joined by Justices Ginsburg and Sotomayor; dissenting opinion by Justice Gorsuch, joined by Chief Justice Roberts

  • By Kevin E. Noonan

    Supreme Court Building #3The Supreme Court reversed the judgment of the Federal Circuit today in SAS Institute Inc. v. Iancu.  In a rare close decision in patent cases, Justice Gorsuch (joined by the Chief Justice and Justices Kennedy, Thomas, and Alito) provided 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 (by rule; 37 C.F.R. § 41.108(a)) 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.

    According to the majority, the decision to institute is binary (either the PTAB decides to institute or not), but once instituted, the Board must render a decision on all challenged claims.  Justice Gorsuch in his opinion set forth the relevant statutory language he believed supported the Court's opinion and the various procedures (one "inquisitorial" in nature, like ex parte reexamination, in contrast to the more adjudicatory IPR procedure).  IPRs "look[] a great deal like civil litigation," in his opinion and are governed by express provisions in the statute regarding the standards for instituting an IPR (§§ 311-314), conducting the IPR proceeding (§ 316), settlement (§ 317) and coming to a final decision on patentability (§ 318).

    Justice Gorsuch's explication of the language of the statute is based on earlier instances of statutory interpretation by the Court as well as with reference to dictionaries and legal scholarship.  Important terms in the statute include the use of the word "any" in 35 U.S.C. § 318(a) (that the Office "shall issue a final written decision with respect to the patentability of any patent claim challenged by the petitioner") to mean "every," stating that "[t]he agency [here, the USPTO] cannot curate the claims at issue but must decide [the validity] of them all."  This interpretation is further supported by the use of the word "shall," which the opinion notes "generally imposes a nondiscretionary duty."  This language provides a "ready answer" to the question presented, the opinion stating that the language of § 318(a) is "both mandatory and comprehensive" with regard to the statutory requirement that the Board render a Final Written Decision on all claims challenged in an IPR petition.

    While stating that this analysis "would seem to make this an easy case," the opinion reviews (and rejects) the Director's arguments to the contrary.  The majority finds no basis in the statute for the Director to have discretion regarding "partial institution."  Indeed, the opinion notes that, unlike in ex parte reexamination, the IPR provisions of the statute do not permit the Director to initiate an IPR sua sponte.  "From the outset, we see that Congress chose to structure a process in which it's the petitioner, not the Director, who gets to define the contours of the proceeding," says the majority.

    The Court majority also sees interpretive meaning in further distinctions between IPR proceedings and ex parte reexamination.  In the latter proceedings, Congress chose "an inquisitorial approach" (analogous to ex parte examination in the first instance) and thus Congress "knew exactly how to" expressly give the Director the discretion he argues he has under the IPR provisions of the America Invents Act.  "Congress's choice to depart from the model of a closely related statute is a choice neither we nor the agency can disregard," according to the opinion, citing University of Tex. Southwestern Med. Center v. Nassar, 570 U.S. 333, 353 (2013).

    Further, the Court's opinion cites the language of § 314, where that language appears to provide either that the IPR proceedings be instituted or that they are not, based on the provision that the Director must decide "whether to institute an inter partes review . . . pursuant to the petition."  Both the terms "whether" and "pursuant to the petition" have meaning to the Court majority.  "Whether" to institute an IPR implies a "yes or no" option, and "pursuant to the petition" supports the earlier-stated view that what is instituted is an IPR on the claims challenged by the petitioner.  As stated in the opinion, "[n]othing suggests the Director enjoys a license to depart from the petition and institute a different inter partes review of his own design" (emphasis in opinion).

    The majority also held that this portion of the statute, which the Director relied upon to imply discretion based on the language that the Director should institute if there is a "reasonable likelihood" that "at least 1 of the claimed challenged by the petition" is invalid, implies exactly the opposite.  For the Court majority, "[o]nce that single claim threshold is satisfied, it doesn't matter whether the petitioner is likely to prevail on additional claims"; the Director should institute the IPR on all challenged claims (emphasis in opinion).  The opinion again references the ex parte reexamination statute to show that if Congress had intended to give the Director the discretion he claims there was language available to do so.

    The opinion summarily rejects the Director's reliance on his discretion under § 314 to institute an IPR to support his discretion to institute partially, once again characterizing the decision as binary.  This conclusion is supported, according to the opinion, by the language of the other provisions in the statute which reference "the petition" rather than challenged claims, the majority interpreting Congress not to have intended the Director to have discretion other than whether or not to institute an IPR against the claims the petitioner challenged.

    With regard to the ambiguity purported to be in the statute due to slight differences in the language of § 314 and § 318 (which forms the basis for the dissent's position), the majority assert that they "just don't see it," characterizing it as a "slight linguistic discrepancy."  Any differences between the claims challenged in the petition and the claims available for Final Written Decision can be explained by the patentee's ability to cancel or amend claims, according to the opinion (terming it a "winnowing mechanism").  The opinion states that "[w]e need not and will not invent an atextual explanation for Congress's drafting choices when the statute's own terms supply an answer," citing U.S. v. Ron Pair Enterprises Inc., 489 U.S. 235, 240-241 (1989).

    Neither are the Director's policy arguments persuasive (in contrast to the effects of these arguments on the dissenting Justices).  Even though "[e]ach side offers plausible reasons why its approach might make for the more efficient policy[,] who should win that debate isn't our call to make," because "[p]olicy arguments are properly addressed to Congress, not this Court."  And "[w]hatever its virtues or vices, Congress's prescribed policy here is clear: the petitioner in an inter partes review is entitled to a decision on all the claims it has challenged" says the Court, nicely closing the door on the basis for the dissenting Justices' contrary opinion.

    Because the majority saw no ambiguity in the statutory language, deference to the agency's implementation decisions under Chevron v. Natural Resources Defense Council did not apply.  In an interesting side note (with regard to Justice Gorsuch's acknowledged antipathy to Chevron), the majority deigns to leave the continued vitality of the agency deference doctrine "for another day," merely holding that "we owe an agency's interpretation of the law no deference" if there is (as here, for these Justices) no ambiguity in the statute's mandate.

    And not surprisingly, the Court rejects the Director's final argument that the question before it is one regarding the institution decision, which Congress under § 314(d) put beyond judicial review, citing Cuozzo Speed Technologies LLC v Lee (2016).  The majority reminds the Director that Cuozzo recognized a "strong presumption" of judicial review of agency decisions, and that judicial review was necessary to preclude agency "shenanigans" that would "exceed its "statutory bounds."

    Justice Breyer dissented, joined by Justices Ginsberg, Sotomayor, and Kagan.  These Justices did perceive an ambiguity in the differences in language (albeit slight) between § 314 and § 318 sufficient to support both the Director's application of the statute and entitlement to Chevron deference.  To the dissenters, the statutory language is far from being as clear as the majority believes; to them, the statute is "technical, unclear and constitutes a minor procedural part of a larger administrative scheme."  The dissent expressly relies upon Chevron, characterizing it as "an interpretative technique that judges often use in such cases" where the statute contains an ambiguity (and perhaps setting the terms of a future dispute between the Justices on the question of Chevron deference).  Using this technique, the dissent finds such an ambiguity and further that the Director's interpretation of the ambiguous statutory language is reasonable (and thus the dissenting Justices would affirm).  Helpful in considering the dissenting Justices' thinking in this regard, Justice Breyer sets forth a hypothetical (as is his wont) in which a petitioner challenges sixteen claims and the Board institutes an IPR on one of them, and the uses this hypothetical as a practical guidepost for its explication of the statutory language.

    The dissenting opinion performs its own brand of statutory exegesis and, unsurprisingly, finds ambiguity between reference to claims challenged in the petition and claims surviving to Final Written Decision.  These Justices perceive that the majority relies on its own statutory language that actually does not exist in the statute (specifically "'any patent claim challenged by the petitioner' in the petitioner's original petition") and for them, "[w]hich reading we give the statute [theirs or the majority's] makes a difference."  Without expressly making the point, the dissent illustrates that, if these Justices cannot agree on the meaning of the statutory language, such language is prima facie ambiguous and thus Chevron deference should attach to the Director's interpretation.

    In addition, these Justices agreed with the Director's argument that interpreting the statute as the majority did would impose tremendous inefficiencies on the PTAB, requiring them to provide a FWD on claims that the petitioner had not shown had a reasonable likelihood of being invalid.  This point was emphasized in a one-paragraph, separate dissent penned by Justice Ginsberg (joined by the other dissenting Justices), who saw "no cause to believe Congress wanted the Board to spend its time so uselessly."

    One practical consequence of this decision (that Justice Breyer in his dissent fully appreciates) is that it provides a route for a petitioner, unhappy that the Board refused to institute IPR on any particular claim, to appeal the FWD and thus overcome the prohibition in the statute that the institution decision is at the Director's discretion and not appealable.  This is clearly contrary to the legislative scheme (and Justice Sotomayor, one of the dissenting Justices here, at oral argument quizzed counsel aggressively on whether the entire exercise was a way to get around the Court's Cuozzo decision).  This decision also raises the possibility that the Board, rather than issue an appealable FWD on claims that do not rise to the "reasonable likelihood" standard will instead refuse to institute using language in the decision providing a roadmap for further petitions of more limited scope that it will institute.  No matter how the Board adapts its practices to avoid the outcome mandated by this decision, the majority's clear holding provides the basis for the Office and the public to petition Congress to intercede to change the statutory language to give the Director the discretion the Court majority could not find in the statute Congress enacted.

    SAS Institute Inc. v. Iancu (2018)
    Opinion of the Court by Justice Gorsuch, joined by Chief Justice Roberts and Justices Kennedy, Thomas, and Alito; dissenting opinion by Justice Ginsburg, joined by Justices Breyer, Sotomayor, and Kagan; dissenting opinion by Justice Breyer, joined by Justices Ginsburg and Sotomayor, and joined except as to Part III-A by Justice Kagan

  • By Michael Borella

    USPTO SealThe second part of the patent-eligibility test of Alice Corp. v. CLS Bank Int'l involves an inquiry into whether certain elements of a claim directed to an unpatentable judicial exception are "well-understood, routine, and conventional."  If this is the case, the claim fails to meet the requirements of 35 U.S.C. § 101.  If not, the claim clears the § 101 hurdle.  Since Alice, this determination has been largely treated as a matter of law.

    But recently, in Berkheimer vs. HP Inc., the Federal Circuit stated:

    The question of whether a claim element or combination of elements is well-understood, routine and conventional to a skilled artisan in the relevant field is a question of fact.  Any fact . . . that is pertinent to the invalidity conclusion must be proven by clear and convincing evidence.  Like indefiniteness, enablement, or obviousness, whether a claim recites patent eligible subject matter is a question of law which may contain underlying facts

    (Emphasis added.)

    The Court noted that some § 101 disputes may be resolved as a matter of law when there is no material issue of fact regarding whether one or more claim elements, or combination thereof, are well-understood, routine, or conventional to a person of ordinary skill in the art.  Based on this reasoning, HP's summary judgment motion for ineligibility was reversed and remanded to the District Court for further proceedings.  The Court reiterated this position a few days later in Aatrix Software Inc. v. Green Shades Software, Inc. and three times since then in non-precedential decisions.

    On April 19, the U.S. Patent and Trademark Office (USPTO) published a memorandum providing updated § 101 examination guidance that takes the Berkheimer rule into account.  This memo was widely anticipated given that Berkheimer is viewed as one of the more significant § 101 decisions in recent history, and also because at least some Patent Trial and Appeal Board (PTAB) panels have stated that the case's holding does not apply to their review of patent-eligibility rejections from examiners (see, e.g., Decision on Request for Rehearing in Ex parte Daniel R. Swanson Sr.). 

    In the memo, the Office begins by reviewing the Berkheimer case and acknowledging its importance.  The Office writes:  "[w]hile the Berkheimer decision does not change the basic subject matter eligibility framework as set forth in MPEP § 2106, it does provide clarification as to the inquiry into whether an additional element (or combination of additional elements) represents well-understood, routine, conventional activity."

    The Office goes on to specify how the case impacts examination procedure.  Notably, when applying the second part of the Alice test, an examiner should not find that an additional element is well-understood, routine or conventional unless the examiner can expressly support (in writing) one of the following four rationales.

    1. "A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s)."  But, an element is not well-understood, routine, or conventional if "the specification is silent with respect to describing such element."

    2. "A citation to one or more [court decisions] noting the well-understood, routine, conventional nature of the additional element(s)."

    3. "A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s)."  This does not include all publications that could qualify as prior art under § 102, however.  Particularly, "the description of the additional elements in the publication would need to demonstrate that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a)."

    4. "A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s)."  An examiner should only take this option "when the examiner is certain, based upon his or her personal knowledge, that . . . the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a)."  Of course, the applicant can challenge the official notice following the procedures of MPEP § 2144.03, which should result in the examiner having to rely on one of the first three rationales.

    This guidance certain is welcome.  Conclusory reasoning is not uncommon in § 101 rejections and examiners who follow this guidance will be less likely to rely upon such a technique.  But there are reasons why we might not expect this guidance to result in a substantive change in examination.

    The second rationale requires a citation to case law indicating that a claimed element is similar to something found to be well-understood, routine, or conventional by the Supreme Court or Federal Circuit.  There are many such decisions, numerous ones of which involve conclusory reasoning themselves regarding additional elements.  Also, there is little discussion in the memo as to how examiner as supposed to consider whether a combination of additional elements constitutes significantly more.  Thus, use of this rationale might not, in truth, avoid the problem that the USPTO is trying to solve.

    Additionally, the USPTO's new emphasis on the second part of Alice may incentivize examiners to lump more elements under the first part, leaving a small number of simple additional elements that can be quickly dismissed as well-understood, routine, or conventional under the second part (i.e., using the second rationale above).  For instance, consider this claim from the USPTO's Example 34:

    1.  A content filtering system for filtering content retrieved from an Internet computer network by individual controlled access network accounts, said filtering system comprising:
        a local client computer generating network access requests for said individual controlled access network accounts; at least one filtering scheme;
        a plurality of sets of logical filtering elements; and
        a remote ISP server coupled to said client computer and said Internet computer network, said ISP server associating each said network account to at least one filtering scheme and at least one set of filtering elements, said ISP server further receiving said network access requests from said client computer and executing said associated filtering scheme utilizing said associated set of logical filtering elements.

    The USPTO stated that this claim is eligible.  Nonetheless, an examiner may still review the claim elements piecemeal.  For example, the examiner might contend that the claim is directed to the abstract idea of content filtering, and that the additional elements of a local client computer, remote ISP server, and computer network are well-understood, routine, and conventional.  By grouping as many elements as possible under the looser rubric of part one, it is easier to justify, even under the new guidance, that a claim is ineligible.

    In short, the memo gives applicants a few more tools for rebutting examiners, but the scourge of § 101 rejections with little or no supportive reasoning is far from over.

  • By Antony Craggs* —

    EPOThe therapeutic methods exclusion is often problematic to navigate.  In T 0699/12, the Technical Board of Appeal (TBA) of the European Patent Office (EPO) has provided some useful guidance on its application.  In an opposition before the Opposition Division, the division held that the patent in suit (which was for a method for performing in vivo dosimetry) was invalid pursuant to Art 53(c) of the European Patent Convention (EPC).

    Art. 53(c) of the EPC states:  "European patents shall not be granted in respect of:  . . . methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body . . . ."

    On appeal the Technical Board of Appeal, considering the effect of this provision, referred to decision G 01/04 and explained that it ". . . clarified that a method claim falls under the prohibition of patenting methods for treatment by therapy or surgery under Art. 53(c) EPC if it comprises or encompasses at least one feature defining a physical activity of action that constitutes a method step for treatment of a human or animal body by surgery or therapy . . . ."

    It concluded that Art 53(c), therefore, did not exclude methods from patent protection that are used during a therapeutic or surgical treatment of a human or animal body, but methods that are therapeutic or surgical treatments of a human or animal body.

    Applying this to claim 1 of the patentee's main request, this read as follows:

    1. Method for enabling quantification of dose delivery in radiotherapy treatment, characterized in that it comprises the steps of:
        - irradiation of a phantom following a treatment
    plan of a patient,
        - measurement of the irradiation in said phantom,
        - collecting information regarding the irradiation by information means arranged between the phantom and the radiation source, wherein said measurements are divided in time-intervals, and
        - analysing the measurements for obtaining information regarding the relationship between the measurements in the phantom and measurements in the information means between the phantom and the treatment source at each time-interval,
        - using said relationship information during verification of the treatment of the patient.

    The patent specification further explained that the "invention is thereby a method to calibrate the detectors to be used in vivo (during treatment) in a time-efficient and accurate way to achieve high quality, reliable dose measurements during treatment".

    The Technical Board of Appeal concluded that the wording of claim 1 did not include any step that could be considered as being of surgical or therapeutic nature, since no actual irradiating step was claimed.  It reasoned that the "verification" (namely, 'quantification of the dose delivery' of the treatment) had no therapeutic or surgical effects as such.  Rather, it only determined (verified) the radiation dose during a treatment.

    Expressed another way, the claimed method only concerned the technical operation of a device (the radiation/ treatment source and the information means/detectors) without any functional link to the effects of the device on the body.

    * Mr. Craggs is a patent attorney with D Young & Co

    This article was reprinted with permission from D Young & Co.