• By Andrew Williams

    USPTO SealOn January 12, 2018, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board announced that it had updated its Motion to Amend Study to include all AIA trials through the end of Fiscal Year 2017 (which ended on September 30, 2017).  The original study included data through April 30, 2016.  At that time, only two motions to amend had been granted outright, with another four granted-in-part.  This study was updated last year with data through May 31, 2017.  At that time, two additional motions to amend had been granted outright, with an additional four granted-in-part.  The current study includes no new motions to amend granted outright, but there are two more that have been granted-in-part.  In total, fourteen motions to amend had been granted at least in part as of September 30, 2017 (out of a total of 275 completed trials in which a motion to amend was filed).  Of course, the cut off for this study misses any impact of the October 4, 2017 Aqua Products, Inc. v. Matal decision.  We, however, believe that no additional motions to amend have been granted so far this fiscal year.

    Chart 1
    This updated Motion to Amend Study includes several charts that present data that was obtained.  The first such chart reproduced above highlights just how few trials actually include a motion to amend.  The Purple and Yellow slices represent trials that are still pending, either with or without a filed motion to amend, respectively.  They were otherwise not included in the calculations that followed.  For completed trials, only 275 out of 2,766 trials (or 8%) included a motion to amend.  The Board counted a trial as "completed" when it was terminated due to settlement, when there was a request for adverse judgement, when it was dismissed, or when there was a final written decision.  Moreover, joined or consolidated trials were only counted once in the statistics.  The second chart provided by the Board (not reproduced here) explains the outcome of the motions to amend, whether it was decided in the Final Written Decision, whether it was rendered moot because the claims were patentable, whether it was withdrawn, whether the case settled, whether adverse judgement was requested, whether the case was dismissed, or whether the motion was solely to cancel the claims.  Out of the 275 trials, only 170 motions to amend with substitute claims were decided.

    Chart 2Tellingly, the third chart shows the outcome of the 170 decided motions to amend in which substitute claims were proposed.  In 156 of these cases, or 92%, the Board denied the motion.  The four motions to amend that were granted outright represent 2% of all motions to amend with substitute claims that were decided, and represent a much smaller percentage of all motions to amend.  The ten motions to amend that were granted-in-part represented 6% of the total decided.  The Study included a separate spreadsheet that contained the data from the 275 trials.  This spreadsheet explains in which post-issuance proceedings that motions to amend were granted.  The following tables were compiled from this data:

    Table 1 Table 2
    IPR2014-00090 was interesting because the Board originally denied the motion to amend on April 23, 2015.  However, the Federal Circuit vacated the case in part because it found that the Board had erred on its sole ground for denying the motion.  As a result, on remand, the Board granted the motion-in-part.

    Looking forward to the first few months of fiscal year 2018, we do not believe that the Board has yet granted any motions to amend other than the one in Taiwan Semiconductor Manufacturing Co. v. Godo Kaisha IP Bridge (IPR2016-01249) (reported here). This is interesting because the Aqua Products case came out just as the fiscal year was starting.  At that time, approximately 38 motions to amend were pending.  It is possible that no such motions were granted because practitioners were essentially stuck with the briefing that had already occurred.  The Board has been willing in most cases to allow additional briefing, but it has not been a blanket rule in all case.  As an example, we need look no further than the first PTAB paper after the Aqua Products case, Minerva Surgical, Inc. v. Hologic, Inc., IPR2016-00868, Paper 57.  In that case, the Chief Judge "determined that good cause exists to extend the one-year period for issuing a Final Written Decision" pursuant to 37 C.F.R. § 42.100(c).  This order was most likely entered on October 5, 2017 because the one-year deadline was set to expire on October 6, 2017.  Nevertheless, when the Final Written Decision issued on December 15, 2017, the Board held that "considering the entirety of the record before us, we determine that the preponderance of the evidence shows that the proposed substitute claims are not patentable over the prior art of record."  Cynically, one could speculate that the Board had already come to this conclusion and merely used the language of Aqua Products to insulate its decision.  Nevertheless, the Board in that case did allow the parties additional briefing, so it is probable that the Patent Owner was able to put forth its best argument.  It remains to be seen what will happen in the more recent cases that have only just been instituted, because the Patent Owners in these cases will be able to take full advantage of the knowledge of the Aqua Products case.  Of course, we will probably need to wait about a year for those cases to work through the system.  Nevertheless, they should be captured in some future update of the PTAB's Motion to Amend Study.    

  • By John Cravero

    USPTO SealAbout the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents.

    Acclarent, Inc. v. Ford Albritton, IV

    PTAB Petition:  IPR2018-00268; filed December 1, 2017.

    Patent at Issue:  U.S. Patent No. 9,011,412 ("Apparatus, system and method for manipulating a surgical catheter and working device with a single hand," issued April 21, 2015) claims a system, comprising: a guide catheter insertable through an external body passage of a subject, said guide catheter having a substantially rigid shaft, a proximal opening, a distal opening and a lumen extending between the proximal opening and the distal opening; a handle coupled to the guide catheter, the handle having a handle opening, a handle coupling and a structure, wherein the structure is configured to allow a position of the guide catheter to be controlled by some or all of three fingers of one hand of an operator of the handle, and wherein the handle coupling is configured to couple a source of suction to the lumen; and a working device adapted to be insertable through the handle opening into the lumen of the guide catheter, wherein the structure of the handle is adapted to permit the operator to position a thumb and index finger of the hand to manipulate the working device via a portion of the working device immediately adjacent to the handle opening and to control, by one of the thumb or index finger, an amount of suction coupled to the distal opening of the lumen.

    Petitioner Acclarent, Inc. is challenging the '412 patent on two grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '412 patent is involved in the following litigation:  Dr. Ford Albritton IV v. Acclarent, Inc., Civil Action No. 3:16-cv-03340-D (N.D. Tex.).


    Trans Ova Genetics, LC v. XY, LLC

    PTAB Petition:  IPR2018-00250; filed December 1, 2017.

    Patent at Issue:  U.S. Patent No. 8,652,769 ("Methods for separating frozen-thawed spermatozoa into X-chromosome bearing and Y-chromosome bearing populations," issued February 18, 2014) claims a method of producing a frozen-thawed sorted artificial insemination sample.

    Petitioners Intrexon Corp. and Trans Ova Genetics, LC are challenging the '769 patent on five grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.

    Related Matters:  According to the petition, the '769 patent is the subject of the following litigation:  XY, LLC et al. v. Trans Ova Genetics, LC, No. 1:17-cv-00944 (D. Colo.).  Petitioners have also filed inter partes review petitions on U.S. Patent No. 7,723,116 (IPR2018-00247 and IPR2018-00248; filed 11/30/2017; pending).


    Pfizer, Inc. v. Chugai Pharmaceutical Co.

    PTAB Petition:  IPR2017-01357; filed May 19, 2017.

    Institution of Inter Partes Review; entered December 1, 2017.

    Patent at Issue:  U.S. Patent No. 7,332,289 ("Method of purifying protein," issued February 19, 2008) claims a method for removing contaminant DNA in an antibody-containing sample.

    Petitioner Pfizer, Inc. is challenging the '289 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2).  View the petition here.  Administrative Patent Judges Grace Karaffa Obermann, Rama G. Elluru, and Jacqueline T. Harlow (author) issued a decision instituting inter partes review of whether claims 1-8 and 13 are anticipated under 35 U.S.C. § 102(b) by Shadle; and whether claims 1-8 and 13 are unpatentable under 35 U.S.C. § 103(a) over Shadle.

    Related Matters:  According to the petition, Petitioner has filed a petition for inter partes review of related U.S. Patent No. 7,927,815 (IPR2017-01358; filed 05/19/2017; Instituted 12/01/2017; pending).


    Pfizer, Inc. v. Chugai Pharmaceutical Co.

    PTAB Petition:  IPR2017-01358; filed May 19, 2017.

    Institution of Inter Partes Review; entered December 1, 2017.

    Patent at Issue:  U.S. Patent No. 7,927,815 ("Protein purification method," issued April 19, 2011) claims a method for removing contaminant DNA in a sample containing a physiologically active protein.

    Petitioner Pfizer, Inc. is challenging the '815 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2).  View the petition here.  Administrative Patent Judges Grace Karaffa Obermann, Rama G. Elluru, and Jacqueline T. Harlow (author) issued a decision instituting inter partes review of whether claims 1-7 and 12 are anticipated under 35 U.S.C. § 102(b) by Shadle; and whether claims 1-7 and 12 are unpatentable under 35 U.S.C. § 103(a) over Shadle.

    Related Matters:  According to the petition, Petitioner has filed a petition for inter partes review of related U.S. Patent No. 7,332,289 (IPR2017-01358; filed 05/19/2017; Instituted 12/01/2017; pending).


    Celltrion Inc. v. Genentech, Inc.

    PTAB Petition:  IPR2017-01373; filed May 9, 2017.

    Institution of Inter Partes Review; entered December 1, 2017.

    Patent at Issue:  U.S. Patent No. 6,407,213 ("Method for making humanized antibodies," issued June 18, 2002) claims a humanized antibody variable domain comprising non-human Complementarity Determining Region (CDR) amino acid residues which bind an antigen incorporated into a human antibody variable domain, and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of: 4L, 38L, 43L, 44L, 58L, 62L, 65L, 66L, 67L, 68L, 69L, 73L, 85L, 98L, 2H, 4H, 36H, 39H, 43H, 45H, 69H, 70H, 74H, and 92H, utilizing the numbering system set forth in Kabat.

    Petitioner Pfizer, Inc. is challenging the '213 patent on seven grounds as being obvious under 35 U.S.C. § 103(a).  View the petition here.  Administrative Patent Judges Sheridan K. Snedden, Zhenyu Yang (author), and Robert A. Pollock issued a decision instituting inter partes review of whether claims 1-7 and 12 are anticipated under 35 U.S.C. § 102(b) by Shadle; and whether claims 1-7 and 12 are unpatentable under 35 U.S.C. § 103(a) over Shadle.

    Related Matters:  According to the petition, Petitioner has filed a petition for inter partes review of the same claims of the '213 patent based on different art references.  The '213 patent is also the subject of inter partes reviews IPR2016-01693 (Mylan Pharmaceuticals Inc.; filed 08/30/2016; terminated by settlement before institution 03/10/2017); IPR2016-01694 (Mylan Pharmaceuticals Inc.; filed 08/30/2016; terminated by settlement before institution 03/10/2017).  According to the Institution of Inter Partes Review, the '213 patent is the subject of inter partes reviews IPR2017-01488 (Pfizer, Inc.; filed 05/25/2017; pending); IPR2017-01489 (Pfizer, Inc.; filed 05/25/2017); IPR2017-02031 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 08/31/2017); IPR2017-02032 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 08/31/2017); IPR2017-02139 (Samsung Bioepis Co., Ltd.; filed 09/29/2017; pending); and IPR2017-02139 (Samsung Bioepis Co., Ltd.; filed 09/29/2017; pending).


    Trans Ova Genetics, LC v. XY, LLC

    PTAB Petition:  IPR2018-00249; filed December 4, 2017.

    Patent at Issue:  U.S. Patent No. 6,372,422 ("Multiple sexed embryo production system for mammals," issued April 16, 2002) claims a method of producing multiple, sexed embryos from a non-human female mammal.

    Petitioners Intrexon Corp. and Trans Ova Genetics, LC are challenging the '422 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2-5).  View the petition here.

    Related Matters:  According to the petition, the '422 patent is the subject of the following litigation:  XY, LLC et al. v. Trans Ova Genetics, LC, No. 1:17-cv-00944 (D. Colo.).  Petitioners have filed separate inter partes review petitions on U.S. Patent No. 7,723,116 (IPR2018-00247 and IPR2018-00248; filed 11/30/2017; pending) and U.S. Patent No. 8,652,769 (IPR2018-00250; filed 12/01/2017; pending).


    KVK-Tech, Inc. v. Shire PLC

    PTAB Petition:  IPR2018-00290; filed December 11, 2017.

    Patent at Issue:  U.S. Patent No. 8,846,100 ("Controlled dose drug delivery system," issued September 30, 2014) claims a pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt; wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

    Petitioners KVK-Tech, Inc. and Abhai LLC are challenging the '938 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed an inter partes review petition on related U.S. Patent No. 9,173,857 (IPR2018-00293; filed 12/11/2017; pending).


    KVK-Tech, Inc. v. Shire PLC

    PTAB Petition:  IPR2018-00293; filed December 11, 2017.

    Patent at Issue:  U.S. Patent No. 9,173,857 ("Controlled dose drug delivery system," issued November 3, 2015) claims a method for treating attention deficit hyperactivity disorder (ADHD) which comprises: administering to a patient in need thereof, a pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt; wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

    Petitioners KVK-Tech, Inc. and Abhai LLC are challenging the '938 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3).  View the petition here.

    Related Matters:  According to the petition, Petitioners concurrently filed an inter partes review petition on related U.S. Patent No. 8,846,100 (IPR2018-00290; filed 12/11/2017; pending).

  • By Donald Zuhn –-

    JanssenLast week, the Federal Circuit affirmed the rejection by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board of claims 1-7 of U.S. Patent No. 6,284,471 as being unpatentable under the doctrine of obviousness-type double patenting.  Janssen Biotech, Inc. and New York University ("Janssen"), co-assignees of the '471 patent, argued on appeal that obviousness-type double patenting was not applicable because the safe-harbor provision of 35 U.S.C. § 121 protected the '471 patent claims.  In affirming the Board's decision, however, the Federal Circuit determined that the '471 patent was not entitled to safe-harbor protections.

    The '471 patent issued from U.S. Application No. 08/192,093, which was filed as a continuation-in-part application of U.S. Application Nos. 08/013,413 and 08/010,406.  On the same day that the '093 application was filed, Janssen also filed U.S. Application No. 08/192,102, which was also filed as a continuation-in-part application of the '413 and '406 applications, and which later issued as U.S. Patent No. 5,656,272.  Janssen subsequently filed U.S. Application No. 08/324,799, which was filed as a continuation-in-part of the '093 and '102 applications, and which later issued as U.S. Patent No. 5,698,185.  The relationships of the above applications and patents is shown in the chart below, which is reproduced from the Federal Circuit's opinion.

    Chart
    During prosecution of the '413 application, which relates to antibodies specific to human tumor necrosis factor alpha and included claims directed to a chimeric antibody and methods of treatment, a restriction requirement was issued in which Group I was directed to antibodies, pharmaceutical compositions, and assay methods, and Group IV was directed to methods for treating an animal by administering a pharmaceutical composition containing an antibody. Instead of replying to the restriction requirement, Janssen expressly abandoned the '413 application and filed the '093 and '102 applications as continuation-in-part applications of the '413 and '406 applications.

    The '093 application disclosed and claimed subject matter from both the '413 and '406 applications (the '406 application relates to immunoreceptor molecules that are specific for TNF alpha or beta).  After the '093 application was filed, Janssen allowed the '406 application to go abandoned.  Janssen then filed a preliminary amendment in the '093 application, cancelling method claims designated as the invention of Group IV in the restriction requirement issued in the '413 application.  However, Janssen did not limit the claimed subject matter to only that claimed and disclosed in the '413 application, as the '093 application still included claims directed to chimeric antibodies (based on the '413 application) and immunoreceptor molecules (based on the '406 application), and also retained language regarding binding to the TNF genus generally as opposed to the species of TNF alpha.  In an Office action issued during prosecution of the '093 application, the claims were provisionally rejected on obviousness-type double patenting grounds over the '799 application.  Janssen responded by amending the claims, including limiting claim 1 to TNF alpha.  Janssen also filed preliminary amendments in both the '799 and '102 applications, replacing the pending claims of the '799 application with claims directed to methods of treating rheumatoid arthritis, and the pending claims of the '102 application with claims directed to methods of treating Crohn's disease.

    Following the issuance of another Office action in the '093 application, in which the double patenting rejection was maintained, Janssen responded by arguing for withdrawal of the rejection in view of the amendment of the claims of the '799 application to recite methods of treating rheumatoid arthritis and by pointing to the restriction requirement issued in the '413 application, which Janssen argued precluded an obviousness-type double patenting rejection in the '093 application.  The Examiner withdrew the double patenting rejection, and the '093 application eventually issued as the '471 patent, with claims directed to a chimeric antibody specific for TNF alpha (claims 1, 3, and 5–6), immunoassay methods for detecting human TNF (claims 2 and 4), and polypeptides of particular amino acid sequences that bind to human TNF alpha (claims 8 and 9).

    Twelve years after the '471 patent issued, the USPTO instituted a reexamination of the patent (in response to a third-party request) on double patenting grounds over three patents including the '272 and '195 patents.  During the reexamination, Janssen cancelled claims 8 and 9; requested that the benefit claim to the '406 application be deleted; sought amendment of the specification, abstract, and drawings to delete portions that were not in the '413 application; and requested that the application be designated as a divisional of the '413 application.  The Examiner, however, maintained the double patenting rejections on the basis that the safe harbor did not apply, noting that more than thirty-two issued patents "reached through the '471 patent for benefit of a prior filing date" and that the "patentability of those claims . . . cannot be determined without reopening examination of those patents in view of the deletion of the subject matter in the '471 patent."  The Examiner also determined that the one-way test for double patenting applied because the PTO was not "solely responsible" for the '471 patent's later issuance, and that the claims of the '471 patent were unpatentable under that test.  The Board subsequently affirmed the Examiner's determination, and Janssen appealed the Board's decision to the Federal Circuit.

    In an opinion authored by Chief Judge Prost, and joined by Circuit Judges Reyna and Wallach, the Federal Circuit noted that "[t]he main issue on appeal is whether the safe-harbor provision of 35 U.S.C. § 121 applies to the '471 patent and protects it from invalidation based on the '272 and '195 reference patents."  The opinion also noted that "[t]he § 121 safe harbor, 'by its literal terms, protects only divisional applications (or the original application) and patents issued on such applications,'" quoting Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1360 (Fed. Cir. 2008), and explained that:

    [P]atents issued on CIP applications are not within the scope of § 121.  [Pfizer, 518 F.3d] at 1362.  Nor are patents issued on continuation applications.  [Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1354 (Fed. Cir. 2009)].  Our precedent is clear: aside from the original application and the original patent, the protection afforded by § 121 is limited to divisional applications and patents issued on divisional applications.  Pfizer, 518 F.3d at 1362.

    The panel noted that in G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349 (Fed. Cir. 2015), the question of whether a patent owner can retroactively bring a challenged patent, issued from a CIP application, within the scope of the § 121 safe harbor by amending the CIP application after issuance to redesignate the application as a divisional application was answered by the Federal Circuit in the reissue context, where the Court determined that the patent owner could not take advantage of the safe-harbor provision simply by designating the CIP as a divisional application.  Applying Searle to the instant case, the panel indicated that it was "persuaded by the reasoning in Searle that a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding," stating that "once the '471 patent issued on the '093 application—which, like the application in Searle, at the time of issuance included new matter not disclosed in the original application and so was a properly designated CIP—the '471 patent was barred from safe-harbor protections."

    The panel pointed out that "[t]he '471 patent cannot retroactively become, for the purposes of § 121, a 'patent issued on' a divisional application after it already issued on a CIP application; not even if that CIP application is effectively redesignated as a divisional application during reexamination," and noted that "[f]or a challenged patent to receive safe-harbor protections, the application must be properly designated as a divisional application, at the very latest, by the time the challenged patent issues on that application."  In response to Janssen's argument that it had not enjoyed a benefit from having filed the '093 application as a CIP of the '413 and '406 applications because no issued claims in the '471 patent relied upon the new matter in the '093 application, the panel disagreed, explaining that "the examiner found that Janssen had benefitted because more than thirty patents issued to Janssen claiming priority to the '471 patent and/or the '093 application as a CIP of both the '406 and '413 applications."

    The opinion notes that given the panel's determination that once the '471 patent had issued on a CIP application, it was not entitled to safe-harbor protections of § 121, the panel did not need to consider the USPTO's alternative argument that § 121 does not apply because the '471 patent and the reference patents did not maintain consonance with the restriction requirement made in the '413 application.  In addition, in response to Janssen's argument that the Federal Circuit's holding "creates a rigid 'divisional as filed' test," and ignores longstanding USPTO rules and practices that permit applicants to amend the disclosure and claims of an application after it is filed and to change an application's relationship to a prior-filed application, the panel noted that "[t]hese practices, whether or not they are widely practiced or even permitted under PTO rules, have no relevance here because Janssen did not follow them."  The panel also explained that:

    [W]e do not decide whether such filing practices or amendments made prior to issuance—wherein an application is designated as a divisional application by the time the challenged patent issues on that application—would be sufficient to bring the challenged patent within the scope of the safe-harbor protections.

    The opinion concludes with the panel finding to be unpersuasive Janssen's argument that the Board erred by failing to apply a two-way test for double patenting.  Instead, the panel concluded that Janssen failed to establish that the PTO is "solely responsible" for any alleged delay associated with the issuance of the '471 patent.  Finding that the '471 patent was not entitled to safe-harbor protections, and that the Board did not err in applying the one-way test for double patenting, the Federal Circuit affirmed the Board's rejection of claims 1–7 of the '471 patent as being unpatentable under the doctrine of obviousness-type double patenting.

    In re Janssen Biotech, Inc. (Fed. Cir. 2018)
    Panel: Chief Judge Prost and Circuit Judges Reyna and Wallach
    Opinion by Chief Judge Prost

  • By Kevin E. Noonan –

    USPTO SealIn what everyone (including the Patent Trial and Appeal Board) considers an unprecedented administrative action, the PTAB late last year set out an order (Patent Trial and Appeal Board's Order, 2017 WL 5067421, P.T.A.B. Nov. 3, 2017) inviting amicus briefing on the question of whether the transfer of patent rights from Allergan to the St. Regis Mohawk Nation should lead the Board to dismiss several consolidated inter partes review actions (Nos. IPR2016-01127, IPR2016-01128, IPR2016-01129, IPR2016-01130, IPR2016-01131, and IPR2016-01132, instituted against U.S. Patent Nos. 8,685,930, 8,629,111, 8,642,556, 8,633,162, 8,648,048, and 9,248,191, respectively) on the grounds of sovereign immunity (see "Mohawk Nation Exercises Sovereign Immunity in Inter Partes Review").  The Board has ruled previously that state universities, as "arms of the state," could so assert the immunity and have such IPRs dismissed (see Covidien LP v. Univ. of Fla. Research Found., Inc., Case IPR2016-01274 (PTAB Jan. 25, 2017); NeoChord, Inc. v. Univ. of Md., Balt., Case IPR2016-00208 (PTAB May 23, 2017); and Reactive Surfaces Ltd., LLP v. Toyota Motor Corp., Case IPR2016-01914 (PTAB July 13, 2017)).  The question is not as clear for the Native American tribes, because their sovereign immunity is more proscribed and subject to abrogation by Congress (albeit requiring express and unequivocal government action; see, Santa Clara Pueblo v. Martinez and Ransom v. St. Regis Mohawk Educ. and Cmty. Fund, Inc., 86 N.Y.2d 553, 560 (1995)).  Even assertion of sovereign immunity by the several States is controversial (see "The Wall Street Journal's Problem with the U.S. Constitution"); indeed, the Board denied a motion to dismiss recently based on assertion of the patent in parallel district court litigation (see "PTAB Decides Patent Infringement Lawsuit Waives Eleventh Amendment Sovereign Immunity to Inter Partes Review").

    Despite its unconventionality, fifteen amicus briefs were filed, almost evenly split between those believing that the Tribe could properly assert sovereign immunity and the Board should dismiss the IPRs and those distinguishing this case from the grants of dismissal to state universities on both legal and policy grounds.  (As set forth below, one brief breaks the tie in favor of denying the motion, under a unique contract law theory.)  The briefs were filed by the following parties:

    In favor of granting the motion to dismiss

    Amicus Curiae Brief of the Oglala Sioux Tribe
    Amicus Curiae Brief of The National Congress of American Indians et al.
    Amicus Curiae Brief of Luis Ortiz and Kermit Lopez
    Amicus Curiae Brief of Scholars
    Amicus Curiae Brief of the Seneca Nation
    Amicus Curiae Brief of the NAIPEC
    Amicus Curiae Brief of U.S. Inventor, LLC

    In favor of denying the motion

    Amicus Curiae Brief of the SIIA
    Amicus Curiae Brief of The Association for Accessible Medicines
    Amicus Curiae Brief of The BSA | The Software Alliance
    Amicus Curiae Brief of the Public Knowledge and the Electronic Frontier Foundation
    Amicus Curiae Brief of Askeladden LLC
    Amicus Curiae Brief of Deva Holding A.S.
    Amicus Curiae Brief of the High Tech Inventors Alliance
    Amicus Curiae Brief of James R. Major

    One of these briefs, by practitioners Luis Ortiz and Kermit Lopez challenged the Board's authority to solicit amicus briefs on this question:

    [T]he APA only allows an agency to engage in rulemaking through the notice and comment procedure set forth in 5 U.S.C. § 553, unless the agency is creating rules that "are required by statute to be made on the record after opportunity for an agency hearing."

    And:

    Allowing amici briefs in this IPR by parties aligned with the petitioners does nothing more than allow various commercial interests to complain in the wrong forum.  Only Congress, whose elected members have the authority and duty to make the political decision whether to abrogate sovereign immunity, and who must face voters after such decisions, can choose to eliminate sovereign immunity for Indian tribes in IPRs [emphasis in brief].

    A similar sentiment was echoed in the brief in favor of denying the Tribe's motion, filed by the Public Knowledge and Electronic Frontier Foundation (as amicus collegii), which argued that public notice and comment under the APA are the proper route to permit public comment — "[t]hat procedure would enable participation by members of the public with key knowledge or interests, would guarantee consistency across Board decisions, and would work to avoid conflicts with other policy decisions and positions of the Office."  Certifying the question to the Director would have the advantages that 1) "a notice and comment proceeding would enable all interested parties to participate and provide useful information to the Office and the Board, and to do so without expensive and onerous requirements of retaining registered counsel"; 2) "certification to the Director will avoid inconsistent policy across panels of the Board"; and 3) the Director is best positioned to assess any consequences for the Office as a whole."

    Otherwise, as might be expected, the briefs recite common themes.  Briefs in favor of granting the motion and dismissing the IPRs focus on it being the exclusive provenance of Congress to make any determinations on the scope of sovereign immunity for the Tribes, and that even the Supreme Court has been circumspect in encroaching on Congressional purview in this regard.  These briefs also advocate the policy goals of tribal self-sufficiency; for example, the Oglala Sioux tribe's brief with regard to public policy of encouraging tribes for commercial activity and self-sufficiency, cities White Mountain Apache Tribe v. Bracker to the effect that these efforts can't just be "casinos alone."  Several of these briefs take solace in Justice Sotomayor's concurring opinion in Michigan v. Bay Mills Indian Community, 134 S.Ct. 2024(2014).  In that case, the Justice stated that:

    "Tribes face a number of barriers to raising revenue in traditional ways," and, thus, "[i]f Tribes are ever to become more self-sufficient, and fund a more substantial portion of their own governmental functions, commercial enterprises will likely be a central means of achieving that goal."  134 S.Ct. at 2041 (Sotomayor, J., concurring) (emphasis added).

    The Ortiz and Lopez brief argues that "[t]he PTO has no expertise in determining the scope of sovereign immunity in any context" and addressed the policy arguments by saying "[t]he Board cannot interpret the statutes it administers to meet a policy goal contrary to clearly stated Congressional will, nor can the Board manipulate the statutes it interprets in a way not commensurate with Congressional intent," citing Utility Air Regulatory Grp. v. EPA, 134 S.Ct. 2427, 2445 (2014).  And, using the types of assessments the Supreme Court has been known to employ, their brief argues that the Leahy-Smith America Invents Act was enacted in light of current precedent regarding tribal sovereign immunity, including Kiowa Tribe of Okla. v. Manuf'g Techs., Inc., 523 U.S. 751 (1998), Okla. Tax Comm'n v. Citizen Band Potawatomi Indian Tribe of Okla., 498 U.S. 505 (1991) ("Potawatomi I"), and Santa Clara Pueblo v. Martinez, 436 U.S. 49 (1978) — Potawanomi being particularly relevant because it involved sovereign immunity regarding a tribe's commercial activity — ("not a close call") under Michigan v. Bay Mills Indian Community, 134 S.Ct. 2024, 2037 (2014), that it is up to Congress to limit tribal sovereign immunity.  Finally, this brief uniquely cites Executive Order 13175 in support of "tribal sovereignty and self-determination" and that "[a]gencies shall respect Indian tribal self-government and sovereignty."

    The brief from the National Congress of American Indians raised the pending Supreme Court decision in Oil States and Congressional action (including the STRONGER Patents Act) as reasons for the Board to delay making a decision, counsel that may be less persuasive in view of the statutory 12-month time limit on rendering a decision (albeit tempered by the additional 6-month extension available under extraordinary circumstances, a standard the current situation should easily satisfy).  This brief also finds support for sovereign immunity outside the Constitution (which could be restricted to the States), finding the basis for the immunity in English common law, ALEXANDER HAMILTON, THE FEDERALIST NO. 81, 548-49 (Jacob E. Cooke ed., 1961).  Insofar as the immunity derives from common law it should be "applicable to all sovereigns: federal, state, tribal, and foreign."

    The common themes that 1) abrogation of sovereign immunity is limited to Act of Congress, and 2) the PTAB would be outside of its Constitutional scope as an Article I court is found in briefs from the Seneca Nation and U.S. Invent, an inventor group, the latter brief arguing:

    [I]t would be inconceivable that an Article I administrative agency has the authority to make binding decisions concerning the applicability of Native American tribal sovereign immunity when the U.S. Supreme Court — which has plenary judicial oversight of that same administrative agency — has declared that absent Congressional legislation, the Court does not have the power to qualify or limit the assertion of Native American sovereign immunity.

    This point is also the focus of a brief from a group of Constitutional scholars, including Lawrence Tribe, William Eskridge Jr., Erwin Chemerinsky, Joseph Singer, David Orozco, and Jonathan Massey.  This brief (as well as the Seneca Nation brief) cites Republic of Philippines v. Pimentel, 553 U.S. 851, 864 (2008), which states that "once a tribunal recognizes that an assertion of sovereign immunity is 'not frivolous,' it is 'error' for the tribunal to proceed further to address the merits."  The brief also asserts that the question of tribal sovereign immunity is beyond the Board's "statutory purview and institutional expertise":

    The Supreme Court has established that administrative agencies should not decide questions — especially complex and sensitive questions, such as those arising from Petitioners' arguments against tribal sovereign immunity — beyond their statutory purview and institutional competence.  In such situations, agencies lack the expertise to resolve broader policy issues and risk interference with Congress's legislative prerogatives.  Further, an agency acting beyond its purview lacks legitimacy and accountability.  Controversial measures such as Petitioners' proposed restrictions on tribal sovereign immunity require a broader national democratic debate than an agency like the Board can provide [citing Hampton v. Mow Sun Wong, 426 U.S. 88, 116 (1976), Greene v. McElroy, 360 U.S. 474 (1959), and King v. Burwell, 135 S. Ct. 2480, 2489 (2015)].

    This institutional incompetence is exacerbated by the allegations that:

    [T]he Allergan/Mohawk contract is a 'sham agreement'[,] a 'sham assignment'[,] a 'scheme[] to buy tribal immunity for dubious activities'[,] and even an example of 'rent-a-tribe' schemes" [internal quotation marks and citation omitted] because "[n]ot only are these arguments highly disrespectful to the sovereign Tribe, but adjudicating them will embroil the Board in an intrusive and politically charged inquiry into tribal motivations and the policy wisdom of tribal economic freedom.  These are issues for Congress, not the courts, and not an agency.

    Allegations that the underlying agreement is a sham are also addressed in an amicus brief from the Native American Intellectual Property Enterprise Council.

    In like manner, briefs from amici arguing that the PTAB should deny the Tribe's petition make many of the same arguments, the most prominent of which is that IPRs are proceedings in rem ("one against the world") and not in personem, and that sovereign immunity does not bar these proceedings, analogous to bankruptcies.  The brief from the BSA/The Software Alliance argues that the IPR provisions of the AIA are "statutes of general applicability" (an argument also made in the brief from Askeladden LLC) subject to what they call the Tuscarora rule, from Fed. Power Comm'n v. Tuscarora Indian Nation, 362 U.S. 99, 116 (1960), that such statutes apply unless the application is related to or would abrogate some aspect of tribal autonomy or self-governance.  This brief, as well as most of the other briefs on this side of the question, take the language of the Supreme Court's Cuozzo opinion (see "Cuozzo Speed Technologies LLC v. Lee (2016)") that IPRs are not "mini-trials" or in the form of a lawsuit but rather specialized agency proceedings (despite the rhetoric from supporters of these proceedings that they are indeed intended to be in the form of an adversarial proceeding as a substitute for litigation).

    The policy argument in this brief, as well as others in favor of denial, is that "the IPR process serves to advance the important public policy—rooted in the Constitution's Patent and Copyright Clause—of ensuring that the American public and economy are not burdened by unwarranted monopolies."  The brief also analogizes the IPR proceedings to other agency actions, including NLRA (NLRB v. Little River Band of Ottawa Indians Tribal Gov't, 788 F.3d 537, 555–56 (6th Cir. 2015)), OSHA (Menominee Tribal Enters. v. Solis, 601 F.3d 669, 674 (7th Cir. 2010); Reich v. Mashantucket Sand & Gravel, 95 F.3d 174, 177–82 (2d Cir. 1996)), ERISA (Smart v. State Farm Ins. Co., 868 F.2d 929, 932–36 (7th Cir. 1989)), and EEOC (EEOC v. Fond du Lac Heavy Equip. & Constr. Co., 986 F.2d 246, 249 (8th Cir. 1993).

    The brief from the Association for Accessible Medicines makes similar arguments, characterizing their "significant interest in ensuring that brand-name drug manufacturers are not allowed to abuse the U.S. patent system by attempting to invoke rented Native American tribal immunity to frustrate the Board's authority to review erroneously issued patents."  This brief emphasizes the purported "sham" nature of the assignments and echoing the in rem arguments made by other amici.  This brief also analogizes to other cases involving private property and inapplicability of sovereign immunity, all under state law (Anderson & Middleton Lumber Co. v. Quinault Indian Nation, 929 P.2d 379, 381 (Wash. 1996); Smale v. Noretep, 208 P.3d 1180, 1180 (Wash. Ct. App. 2009); Cass Cnty. Joint Water Res. Dist. v. 1.43 Acres of Land, 643 N.W.2d 685, 688 (N.D. 2002)).  Their contribution to the policy argument is to assert that:

    [A]llowing a drug company patent owner to force an IPR to halt on the eve of an IPR hearing, by paying tens of millions of dollars to rent tribal immunity, would reward bad-faith behavior.  It would also provide other holders of weak but extremely profitable patents with a roadmap for shielding their patents from review while wasting the valuable resources of their competitors and the Board.

    And:

    Prior Board decisions involving sovereign state entities are of limited relevance here because none of those cases involved last-minute bad-faith transfers specifically intended to divest the Board of its authority to take a second look at an issued patent—actions that cannot be squared with equity or good conscience.

    The brief from the Software and Information Industry Association characterizes IPRs as a compromise intended to improve patent quality and "restore confidence in the presumption of validity afforded patents issued by the Patent and Trademark Office."  The brief (as is also argued in the brief from Askeladden LLC) relies heavily on Judge Bryson's decision granting the Tribe's motion to join ANDA litigation involving some of these same patents:

    The essence of the matter is this: Allergan purports to have sold the patents to the tribe, but in reality it has paid the Tribe to allow Allergan to purchase—or perhaps more precisely, to rent—the Tribe's sovereign immunity in order to defeat the pending IPR proceedings in the PTO . . . .  If that ploy succeeds, any patentee facing IRO proceedings would presumably be able to employ the same artifice.  In short, Allergan's tactic, if successful, could spell the end of the PTO's IPR program, which was a central component of the America Invents Act of 2011.

    According to this brief, if the Board does not deny this motion, tribal immunity will be asserted in most if not all IPRs (a fear not without some justification; see "More Instances of Tribal Sovereign Immunity Shielding Patents from PTAB Invalidation").

    A brief from the High Tech Inventors Alliance, Computer & Communications Industry Association, and Internet Association repeats the argument that patent laws are law of general applicability from which sovereign immunity provides no protection, basing this characterization in part because "[private petitioners] cannot compel the Patent Office to conduct a review and their ongoing participation is unnecessary to complete one" (another argument also made in the brief from Askeladden LLC).  According to this brief, "[i]nter partes review is thus 'less like a judicial proceeding and more like a specialized agency proceeding' in which third parties that petition for review 'need not have a concrete stake in the outcome; indeed, they may lack constitutional standing,'" citing Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2143-44 (2016).  According to this brief (in an argument made nowhere else), "tribes that own patents must, like all other patentees, pay the fees to maintain the patent, or else the patent will expire.  See 35 U.S.C. § 41(b).  The condition that the Patent Office may reexamine or review the patent is no different."

    At least one of the amici arguing for denial of the Tribe's motion has a specific interest in the decision:  Deva Holding A.S. is a Turkish company, in an "early stage" lawsuit against Allergan.  This amicus argues that substitution is unnecessary (and thus tribal sovereign immunity does not prevent IPRs to proceed) because the Tribe and Allergan have identical interests based on litigation conduct, and so Allergan can represent the Tribe's interests — "actions speak louder than words."  In this argument, the purported inconsistency of positions before the Board and the Court, citing a specific September 8, 2017 letter to the Court, mandate this conclusion and provide sufficient basis to deny the Tribe's motion.

    In addition to its recommendation that the Board would be better to certify the question to the PTO Director, the amicus collegii brief from the Public Knowledge and Electronic Frontier Foundation cites Hazel-Atlas Glass Co. v. Hartford-Empire Co. and Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co. (inequitable conduct) for the "patents in the public interest" concept, saying that the PTAB is an "agency of public justice" and draws analogies to Supreme Court decisions precluding limitations on challenging validity, including Laboratories v. University of Illinois Foundation, Medimmune v. Genentech, Cardinal Chem. Co. v. Morton Int'l, Inc., and Lear v Atkins.

    The brief from James R. Major, D. Phil., opposes the tribe's motion on contractual grounds, arguing that Tribe's patent rights outside the grantback to Allergan are illusory and thus the assignment nugatory, and that the Tribe has no independent interests to assert.  These rights include "research, scholarly use, teaching, education, patient care incidental to the foregoing, sponsored research for itself and in collaborations with Non-Commercial Organizations . . . ."  Dr. Major's point is that the Tribe already had these rights because they were immune from patent infringement liability due to the exercise of sovereign immunity:

    In sum, any infringement suit that the Tribe has the first right to bring would fail.  Therefore, the right of the Tribe to enforce the Licensed Patents in infringement suits unrelated to a Generic Equivalent is nugatory.

    In Dr. Major's view, "the Agreement has stripped the Tribe of any meaningful rights in the Licensed Patents."

    The time for filing amicus briefs in this matter has passed, and the Board is scheduled to render its decision by spring.

  • By Michael Borella

    Federal Circuit SealAs patent-eligibility stands in 2018, it can be difficult to determine whether a graphical user interface (GUI) with an innovative layout and/or functionality meets the requirements of 35 U.S.C. § 101.  On one hand, a GUI is almost by definition fundamentally tied to computer operation, and arguably has no non-computer analog.  On the other hand, a GUI that merely displays data in a non-specific layout is likely going to be viewed as a generic technical environment or just extra-solution activity.  In the Federal Circuit, recent cases addressing the eligibility of GUIs have found those claimed at a high level to be ineligible (e.g., Intellectual Ventures I LLC v. Erie Indemnity Co., Intellectual Ventures I LLC v. Capital One Bank (USA), Internet Patents Corp. v. Active Network, Inc.), while a much more detailed claim was found to be eligible, albeit in a non-precedential opinion (Trading Technologies Int'l v. CQG Inc.).

    So the question remains — what level of detail should be recited in a GUI claim to clear the § 101 hurdle?  While we don't have a clear answer, this case provides another data point.

    Core Wireless brought an action against LG in the Eastern District of Texas alleging infringement of U.S. Patent Nos. 8,713,476 and 8,434,020.  LG moved for summary judgment, asserting that the claims were ineligible under § 101, but the District Court denied the motion.  LG appealed.

    As an example, claim 1 of the '020 patent recites (formatted for clarity):

    1.  A computing device comprising a display screen,
        the computing device being configured to display on the screen a menu listing one or more applications,
        and additionally being configured to display on the screen an application summary that can be reached directly from the menu,
        wherein the application summary displays a limited list of data offered within the one or more applications, each of the data in the list being selectable to launch the respective application and enable the selected data to be seen within the respective application, and
        wherein the application summary is displayed while the one or more applications are in an un-launched state.

    The Supreme Court's Alice Corp. v. CLS Bank Int'l case 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 generic computer implementation of an otherwise abstract process does not qualify as "significantly more."  On the other hand, a claimed improvement to a computer or technological process is typically patent-eligible.

    The Federal Circuit began its analysis by determining that the claimed invention was an improved user interface, rather than the abstract idea of an index, as proposed by LG.  The Court noted that the claims "are directed to a particular manner of summarizing and presenting information in electronic devices."  For instance, claim 1 requires "an application summary that can be reached directly from the menu," and specifies a particular manner by which the summary window must be accessed.  The Court additionally stated:

    The claim further requires the application summary window list a limited set of data, "each of the data in the list being selectable to launch the respective application and enable the selected data to be seen within the respective application."  This claim limitation restrains the type of data that can be displayed in the summary window.  Finally, the claim recites that the summary window "is displayed while the one or more applications are in an un-launched state," a requirement that the device applications exist in a particular state.  These limitations disclose a specific manner of displaying a limited set of information to the user, rather than using conventional user interface methods to display a generic index on a computer.

    The Court made analogies between this invention and those found patent-eligible in Enfish, LLC v. Microsoft Corp., Thales Visionix Inc. v. U.S., Visual Memory LLC v. NVIDIA Corp., and Finjan, Inc. v. Blue Coat Systems, Inc.  The claims in these previous cases were found to improve a computer or technological system, and were thus not abstract.

    To back up its position, the Court looked the patents' specifications, observing that they teach of the problems associated with prior art interfaces, especially with respect to displaying information on devices with small screens.  Particularly, users had to "drill down through many layers to get to desired data or functionality [which] could seem slow, complex and difficult to learn, particularly to novice users."  In contrast, the claimed invention involves "[d]isplaying selected data or functions of interest in the summary window allows the user to see the most relevant data or functions without actually opening the application up."  Doing so "saves the user from navigating to the required application, opening it up, and then navigating within that application to enable the data of interest to be seen or a function of interest to be activated."

    Based on this understanding, the Court concluded that the claim was not abstract, and that part two of the Alice test need not be carried out because the invention was eligible.

    A recent trend in § 101 jurisprudence is the increasing importance of process over substance.  If a Federal Circuit panel reviews claims after they were construed by the district court, refuses to summarize the claimed invention at a high level in part one of the Alice inquiry, and considers the teachings of improvements set forth in the specification in parts one or two of this inquiry, it is much more likely that the Court will find the claims in question to be eligible.  Conversely, if the Court reviews claims that were not construed, summarizes these claims as a simple concept, and puts little emphasis on the specification, the opposite outcome is almost certain.

    As we have seen different panels of Federal Circuit judges adopt both of these approaches, it is no wonder that patentees and attorneys have been shaking their heads when new § 101 cases come down, and that the USPTO has applied the law as inconsistently as the courts.  While the outcome in this particular case is reasonable and well-grounded in logic, it may be only a matter of time before the Federal Circuit realizes that it is suffering from an intra-circuit split and decides to hear a § 101 case en banc.

    • Judge Moore wrote this opinion and was joined by Judge O'Malley.  Judge Wallach dissented in part with respect to a claim construction issue, but agreed with the majority on the patent-eligibility dispute.

    Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc. (Fed. Cir. 2018)
    Panel: Circuit Judges Moore, O'Malley, and Wallach
    Opinion by Circuit Judge Moore; opinion concurring-in-part and dissenting-in-part by Circuit Judge Wallach

  • By Kevin E. Noonan –

    The interference between the Broad Institute and the University of California/Berkeley has been in the spotlight over the past year (see "PTAB Decides CRISPR Interference — No interference-in-fact"; "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning"; "University of California/Berkeley Appeals Adverse CRISPR Decision by PTAB"; and "Berkeley Files Opening Brief in CRISPR Appeal").  But there have been other skirmishes between the parties, each of which has recently been (for now) resolved.

    Broad InstituteThe more significant one is the decision on January 17 by the Opposition Division (OD) of the European Patent Office to revoke in its entirety Proprietors The Broad Institute, MIT, and Harvard College's European Patent No. EP 2771468, which had been opposed by Novozymes A/S, CRISPR Therapeutics GG, and several strawmen).  Representative claims revoked by the OD are as follows:

    1.  A non-naturally occurring or engineered composition comprising:
        a Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system chimeric RNA (chiRNA) polynucleotide sequence, wherein the polynucleotide sequence comprises
            (a) a guide sequence of between 10 – 30 nucleotides in length, capable of hybridizing to a target sequence in a eukaryotic cell,
            (b) a tracr mate sequence, an
            (c) a tracrRNA sequence
            wherein (a), (b) and (c) are arranged in a 5' to 3' orientation,
        wherein when transcribed, the tracr mate sequence hybridizes to the tracrRNA sequence and the guide sequence directs sequence-specific binding of a CRISPR complex to the target sequence,
        wherein the CRISPR complex comprises a Type II Cas9 protein complexed with (1) the guide sequence that is hybridized to the target sequence, and (2) the tracr mate sequence that is hybridized to the tracrRNA sequence,
        wherein the tracrRNA sequence is 50 or more nucleotides in length.

    2.  A Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) vector system comprising one or more vectors comprising
        I. a first regulatory element operably linked to a nucleotide sequence encoding a CRISPR-Cas system chimeric RNA (chiRNA) polynucleotide sequence as defined in claim 1, and
        II. a second regulatory element operably linked to a nucleotide sequence encoding a Type II Cas9 protein comprising one or more nuclear localization sequences, of sufficient strength to drive accumulation of said Cas9 protein in a detectable amount in the nucleus of a eukaryotic cell;
        wherein components I and II are located on the same or different vectors of the system.

    12.  Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon for genome engineering, provided that said use is not a method for treatment of the human or animal body by surgery or therapy, and provided that said use is not a process for modifying the germline genetic identity of human beings.

    17.  Use of the composition of claim 1, or the vector system of claim 2 or any claim dependent thereon, in the production of a non-human transgenic animal or transgenic plant.

    The OD has not yet issued its formal opinion (which can be expected in the next month or so), but last year it did issue a preliminary opinion prior to summoning Proprietor Broad Institute and the opponents to oral hearing earlier this month.  In that opinion the OD "preliminarily and non-bindingly" set forth its opinions, on novelty, inventive step, sufficiency of disclosure, and entitlement to priority; the latter ground for opposition apparently formed the basis for the OD's decision to revoke.

    The preliminary opinion found claims 1 and 2 did not satisfy Article 123(2) EPC, because the claim limitation "one or more of the guide, tracr and tracr mate sequences are modified in order to preserve stability" went beyond the disclosure of the application as filed.  Similar deficiencies of disclosure were found for claims 14 and 15 but not for claim 16.  In view of the OD's preliminary priority determination (see below), claims 1-6 and 9-17 were invalid on novelty grounds and claims 7 and 8 invalid on inventive step grounds.

    The priority issue was raised based on the earliest two provisional applications (U.S. Provisional Application Nos. 61/736,527 and 61/748,427), as well as U.S. Provisional Application Nos. 61/791,409 and U.S. 61/835,931, which named Luciano Marraffini as an inventor, and which were owned by Rockefeller University.  The priority documents and their named inventors are as follows:

    • U.S. 61/736,527 named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini as inventors
    • U.S. 61/748,427 named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini as inventors
    • U.S. 61/758,468 named Zhang, Cong, Hsu, and Ran as inventors
    • U.S. 61/769,046 named Zhang, Cong, Hsu, and Ran as inventors
    • U.S. 61/791,409 named Zhang, Cong, Hsu, Ran, Habib, Cox, Lin and Maraffini, Bikard and Jian as inventors
    • U.S. 61/802,174 named Zhang, Cong, Hsu, Ran, and Platt as inventors
    • U.S. 61/806,375 named Zhang, Cong, Hsu, Ran, and Platt as inventors
    • U.S. 61/814,263 named Zhang, Cong, Hsu, Ran, and Platt as inventors
    • U.S. 61/819,803 named Zhang, Cong, Hsu, Ran, and Platt as inventors
    • U.S. 61/828,130 named Zhang, Cong, Hsu, Ran, and Platt as inventors
    • U.S. 61/835,931 named Zhang, Cong, Hsu, Ran, Cox, Lin, Maraffini, Platt, Santjana, Bikard and Jian as inventors
    • U.S. 61/836,127 named Zhang, Cong, Hsu, and Ran as inventors

    In Europe, under Article 87 EPC and Paragraph IV of the Paris Convention, priority to an earlier-filed application can be validly claimed by the prior applicant or by her successor in interest.  In either case, the applicant must be someone having the right to claim priority.  In the U.S., these provisional applications were filed in the name of the inventor and the EPO requires that there be an assignment of the invention on or before a European or PCT application is filed.  (Of course, a PCT can always be filed naming the inventors as applicants.)  In this case, proper application of the applicable rules required both the named applicants (The Broad Institute, MIT and Harvard College) and the Rockefeller to have been named as applicants when the application was filed.  Rockefeller was not named as an applicant.  Accordingly, the OD determined that the named Proprietors could only validly claim priority to the third provisional application, and by the filing date of that application there had published prior art that invalidated the granted claims.  In this regard, the preliminary opinion may provide guidance on the OD's thinking, where that opinion states that "In both the EPC and the Paris convention systems the decisive fact for a valid claim of priority is the status of applicant, rather than the substantial requirement [] to the subject matter of the first application" (emphasis in opinion).  The OD determined (preliminarily) that "neither the requirement of the applicant's identity nor the proof of a valid success in title [had] been fulfilled" for the claimed invention, and stresses that these were requirements to promote legal certainty that would protect third parties' interests, and that these requirements were not subject to the national law of the priority document.  Nor, according to the preliminary opinion could the granted European patent properly claim priority to U.S. 61/758,468 because that document failed to disclose the length of the guide sequence as claimed.

    The Broad argued that this was a misapplication of Article 87 and the Paris Convention, and that priority should be determined based on the national law of the priority document.  Here, the earlier provisional applications (in the Broad's view) disclosed more than one invention, and the invention pursued in the granted European patent was invented by the Harvard, MIT, and Broad inventors, and not by Dr. Marraffini.  Accordingly, those inventors through their assignees properly claimed the priority right to what was disclosed in those provisional applications and contained in the granted European patent.

    The Broad filed a notice of appeal and in a press release evinced an intention to make some of these arguments before the Technical Boards of Appeal (although many believe that the decision is consistent with how the EPO has administered their law of priority and that the Broad faces a difficult task in seeking to overturn the OD's decision).

    Paradoxically, just two days before the OD's decision, the Broad won its arbitration against the Rockefeller and Dr. Maraffini, wherein U.S. patents claiming priority to some of the same provisional applications were determined to properly exclude Dr. Maraffini as an inventor and to quiet title to these patents with the Broad et al. and not the Rockefeller.  This occurrence was not considered by the OD (who deemed its submission two days prior to oral proceedings to be untimely) and may not be particularly relevant to the Broad's appeal, insofar as it is another example of the differences between U.S. law and the EPC regarding a priority determination.

  • By Kevin E. Noonan –

    One of Donald J. Trump's signature campaign promises was to reject the Trans-Pacific Partnership negotiated by the Obama administration, and true to his word he did just that almost immediately upon being sworn into office (see "Why President Trump Is Wrong about Trans-Pacific Partnership Agreement").  This action raised questions about the fate of the agreement, which had as a trigger for coming into force that the signatories make up 34% of global GDP.  Last July, representatives of the "TPP-11" (all of the TPP member states other than the United States, i.e., Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam) met to discuss implementation of the TPP without U.S. involvement.  They indicated then that they would continue to meet and negotiate, and expressed hope that they would be able to finalize a trade agreement by the end of the year having only minimal differences from the original text of the TPP agreement.

    1104px-TPP_members.svg
    Today, the Financial Times reported that the TPP-11 have indeed come to an agreement and plan on ratifying the TPP in March, sourcing the information from the Japanese government.  The process has resulted in a name change:  the agreement is now called the Comprehensive and Progressive Agreement for Trans-Pacific Partnership or CPTPP and, according to FT, "lays down a marker to China by setting high legal standards for trade and opens up the possibility of other Asian countries joining the pact."

    As a reminder of opportunities lost, and provided there have been no wholesale changes in the treaty during current negotiations, the IP provisions of the treaty have broad scope, encompassing copyrights, trademarks, patents, and trade secrets.  These provisions are aimed at establishing a minimum level of protection among the member states, and to harmonize such protections where possible.  The patent provisions define eligible subject matter broadly, for "any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step and is capable of industrial application."  Market exclusivity provisions regarding agricultural products are granted for at least 10 years, and regulated pharmaceutical products are entitled to at least five years of market exclusivity.  Signatories will provide a legal framework for the pharmaceutical license holder to challenge approval and marketing of any generic version of a patented drug. Biologic drugs are afforded at least eight years of market exclusivity, or at least five years combined with other regulations in a signatory country that would result in at least eight years of exclusivity.  All these provisions are subject to further review by the signatories after 10 years, to provide the ability to adapt the exclusivity term based on experience.  These exclusivity terms—which are shorter than those available to biologic drug innovators in the United States (12 years) or Europe (10 years)—are longer than the terms (i.e., no exclusivity term) available in many of the signatory states.  These provisions provided in signatory countries the prospect that patent protection would be supported by regulatory regimes that encourage investment in creating distribution and professional networks to bring patented pharmaceuticals to these populations that might otherwise be unattractive for such investment.  Paradoxically in view of those that believed the treaty would preclude access to lifesaving medicines in developing countries, having this framework might actually have increased the likelihood that such drugs become more generally available in those countries.

    The agreement also contains enforcement provisions for protecting IP rights, aimed at "permit[ting] effective action against any act of infringement of intellectual property rights covered by this Chapter, including expeditious remedies to prevent infringements and remedies that constitute a deterrent to future infringements," available in equal measure for patent, copyright, or trademark infringement.  In addition to damages and the possibility of an injunction against future infringement, the agreement empowers signatories to destroy infringing articles, particularly counterfeit goods, and there are particular provisions relating to counterfeit articles identified at a signatory's borders.  The TPP further provides, for the first time in an international trade agreement, criminal penalties for trade secret theft, as well as criminal enforcement provisions for willful trademark or copyright infringement including counterfeiting, intercepting or transmitting without authorization an encrypted program-carrying cable signal, and provisions relating to Internet service providers with regard to preventing unauthorized use of copyrighted materials.

    The good news for U.S. biologic drug companies is that there are now opportunities for the benefits of the pact to accrue to them, provided that they partner with indigenous companies in member countries or resource their biologic drug production to an affiliate in a TPP country in order to reap the 8-year market exclusivity benefits under the treaty.  Potential bad news includes the loss of U.S. leadership and cultivation of and protections for U.S. interests amongst the signatories.  Potentially worse news is the potential for China to enter the vacuum of leadership created by U.S. withdrawal.  China's participation is evidently contemplated by the TPP-11 (or perhaps more accurately, CPTPP-11), and such entry could further exacerbate trade imbalances that paradoxically were a prime motivation for the current administrations "America First" policy proclivities.  While such sloganeering may create cheering when broadcast to the American electorate, global realities may be much less accommodating to the outcome desired by this Administration's supporters.  One thing is clear:  the CPTPP is unlikely to suffer the fate of other American initiatives abandoned by succeeding administrations (like the League of Nations), and we will likely not be happy when we are on the outside looking in.

    Image of Membership of the Trans-Pacific Partnership by JayCoop, from the Wikimedia Commons under the Creative Commons Attribution-Share Alike 4.0 International license.

  • Claims Directed to Television Survive Abstract Idea Challenge

    By Joseph Herndon

    District Court for the Northern District of CaliforniaIn a recent decision from the U.S. District Court Northern District of California, involving Free Stream Media Corp. v. Alphonso Inc., claims of a television system patent survived a motion to dismiss under 35 U.S.C. § 101.

    The Plaintiff in this action is Free Stream Media Corp., which does business as Samba TV (Samba).  Samba charged Alphonso with infringement of U.S. Patent No. 9,386,356, entitled "Targeting with Television Audience Across Multiple Screens."

    As the patent title reflects, the claimed invention involves the concept of targeting content—including advertising—to television viewers.  A stated goal of the invention reflected in the '356 patent is to take advantage of a missed "revenue opportunity," specifically, the chance to profit by targeting ads to a person's smartphone based on information collected about the person, such as what the person has watched on television.

    The '356 patent describes that a networked device (e.g., a television, a set-top box, a computer, a multimedia display, an audio device, a weather measurement device, a geolocation device) may have access to information associated with a user.  For example, the information may comprise an identification of a movie viewed by the user, weather information, a geolocation information, and/or a behavioral characteristic of the user when the user interacts with the networked device.  Furthermore, the networked device may present to the user information that is irrelevant to the user.  As a result, the user may get tired, annoyed, and/or bored with the networked device.  Additionally, the user may waste a significant amount of time processing the information that is irrelevant to the user.  Therefore, a revenue opportunity may be missed, because an interested party (e.g., a content creator, a retailer, a manufacturer, an advertiser) may be unable to access an interested audience.

    To address this missed "revenue opportunity," the '356 patent proposes using a "relevancy matching server" that is connected to the person's networked device (e.g., television) and mobile device (e.g., a phone or tablet).  The user's TV viewing information is gathered as "primary data," defined as "data that may be associated with a user and matched with targeted data."

    The television may provide the primary data directly (e.g., by identifying the show title or specific commercial being broadcast), or it may capture snippets of audio or video "fingerprint data" from which the current broadcast can be identified.  The invention's "relevancy matching server" then searches a database to find matching "targeted data" (e.g., an advertisement) that relates to what is on the television, and displays the selected targeted ad on the person's mobile device.

    Claim 1 serves as an example of the claims, and is reproduced below:

    1.  A system comprising:
        a television to generate a fingerprint data;
        a relevancy-matching server to:
            match primary data generated from the fingerprint data with targeted data, based on a relevancy factor, and
            search a storage for the targeted data;
        wherein the primary data is any one of a content identification data and a content identification history;
        a mobile device capable of being associated with the television to:
            process an embedded object,
            constrain an executable environment in a security sandbox, and
            execute a sandboxed application in the executable environment; and
        a content identification server to:
            process the fingerprint data from the television, and
            communicate the primary data from the fingerprint data to any of a number of devices with an access to an identification data of at least one of the television and an automatic content identification service of the television.

    Alphonso insisted that the '356 patent "claims nothing more than the abstract idea of selecting and sending targeted data to a person's mobile phone or tablet, based on information gathered about the person, such as what the person has watched on TV."

    Reviewing Alphonso's motion to dismiss, the District Court applied the Alice two-step framework for determining patent eligibility of the claims.

    Samba relied heavily on Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016), which supports the notion that a dividing line can be drawn between patents which merely describe using a computer and/or the internet to carry out pre-existing and well-known tasks and techniques, and those that relate to the functioning of computers themselves (e.g., specific asserted improvement in computer capabilities).  The former will virtually always fail under Alice unless some "inventive concept" can be found in the second step of the analysis; the latter are substantially less easily characterized as merely abstract ideas.

    But Alphonso insisted that the '356 patent likewise claims nothing more than the same basic abstract idea—it teaches targeting advertising (or other data) to a consumer based on using data gathered about what the consumer is watching on TV, i.e., "know your audience."

    Here, the District Court sided with Samba.  The District Court found that the '356 patent is not directed at merely the abstract idea of targeting advertising.  Rather, it describes systems and methods for addressing barriers to certain types of information exchange between various technological devices, e.g., a television and a smartphone or tablet being used in the same place at the same time.

    To be sure, the end goal of the invention is to improve the delivery of relevant information—i.e., targeting advertising (or other content)—but that does not mean that it does nothing more than direct a person of ordinary skill in the art to use a computer system to implement a conventional and known process.

    The District Court found that the claims are directed at specific techniques for connecting the content on a television and a mobile device through purported technological improvements.  As such, the claims pass step 1 of the Alice test and the analysis need go no further.

    Because the District Court found that the '356 patent purports to overcome particular technological barriers to such targeting, Alphonso's characterization of it as claiming only an abstract idea failed, and the motion to dismiss was denied.

    Notably, the District Court distinguished OpenTV, Inc. v. Netflix, Inc., 76 F. Supp. 3d 886 (N.D. Cal. 2014), a case that Alphonso urged is instructive here.  In OpenTV, one of the patents described "[a] method for providing targeted programming to a user outside of the user's home."  The OpenTV court concluded that the patent did not pass Alice muster because:  "The concept of gathering information about one's intended market and attempting to customize the information then provided is as old as the saying, 'know your audience.'  Like the concepts in Bilski and Alice, the mere fact that generic computer processors, databases, and internet technology, can now be used to implement the basic idea, with certain perceived greater advantages, does not give rise to a patentable method."

    Alphonso argued that OpenTV showed that such concepts included in the '356 patent are abstract, and further argued that on their face the claims do not expressly refer to, or obviously address, technological barriers, or how such barriers are being overcome through the invention.  But the District Court found that because the claims plainly describe methods and systems that call for the very kinds of communications between devices that are not possible through conventional devices operating in standard fashion, this distinguishes the OpenTV decision.

    The District Court further noted that to the extent Alphonso argued that the patent does not adequately explain how the barriers are overcome when the described system and methods are employed, such issues do not support a finding of patent ineligibility under Section 101, but rather, are addressed under 35 U.S.C. § 112.

    I agree with the District Court's decision, but it just seems that it should have been arrived at much more quickly.  The claim explicitly recites "a television," "a relevancy-matching server," "a mobile device," and "a content identification server," each of which processes data and communicates various data amongst each other.  How we have come to a place in the law where "a television" is an abstract idea is a bit puzzling for sure.

    Order Denying Motion to Dismiss by District Judge Richard Seeborg

  • By Donald Zuhn –-

    Washington - Capitol #5The failure of Congress to pass appropriations legislation funding government operations on Friday resulted in a shutdown of the Federal government at midnight Eastern Standard Time on Saturday, January 20, 2018.  Prior to Saturday's shutdown, the most recent government shutdown had occurred on October 1-16, 2013.  Interestingly, the current shutdown, which is eighth time federal employees have been furloughed as a result of a gap in budget funding, began on the one-year anniversary of President Trump's inauguration.

    While the shutdown involves the furlough of non-essential personnel and curtailment of agency activities and services, the U.S. Patent and Trademark Office issued a notice that the Office remains operational despite the shutdown.  The Office notes that it can "continue normal operations for a few weeks" because the Office has access to prior year fee collections.  However, the Office also notes that should it exhaust those funds before the shutdown comes to an end, the Office itself would have to shut down at that time, "although a very small staff would continue to work to accept new applications and maintain IT infrastructure, among other functions."

    The failure of the Senate to come to an agreement to end the shutdown late Sunday evening means that the government shutdown will remain in effect until at least noon Eastern Time on Monday, when the Senate is expected to vote to end the shutdown (at least for now) with a short-term spending bill that would last three weeks.  If the shutdown persists until January 30, it could impact the President's second State of the Union address.  As reported by The Hill, Office of Management and Budget Director Mick Mulvaney has suggested that the shutdown could last more than a week; the OMB Director, however, also conceded that there was a chance the shutdown could end on Monday.

    Patent Docs will continue to monitor and report on the impact of the government shutdown on USPTO operations.

  • CalendarJanuary 23, 2018 – "Drafting Software Patents to Survive Section 101 and AIA Challenges — Anticipating and Minimizing the Risk of 101, 103 Rejections, Recent Court Guidance" (Strafford) – 1:00 to 2:30 pm (EST)

    January 25, 2018 – "IP Year in Review And Look Ahead" — Patent Prosecution (LexisNexis) – 2:00 pm (ET)

    January 29, 2018 – "IP Year in Review And Look Ahead" — Patent Drafting (LexisNexis) – 2:00 pm (ET)

    January 31, 2018 – "Paragraph IV Litigation: Best Practices and Practical Tips in 2018" (The Knowledge Group) – 3:00 to 4:00 pm (ET)

    January 31, 2018 – "Obviousness of Biologics Inventions: Strategies for Biologics Claims in the U.S., Europe and China" (Strafford) – 1:00 to 2:30 pm (EST)

    February 2, 2018 – "Classes without Quizzes – Invention, Imagination & Patent Incentives" (John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – 4:00 to 5:30 pm (CST), Chicago, IL

    February 13, 2018 – "Patent Drafting for Machine Learning: Structural Claim Limitations, Avoiding §101 or §112 Rejections" (Strafford) – 1:00 to 2:30 pm (EST)

    February 14, 2018 – "Sect. 112 Indefiniteness in Chemical and Biotech Patent Claims — Drafting and Prosecuting Patent Claims That Will Hold Up Under Any Definiteness Standard" (Strafford) – 1:00 to 2:30 pm (EST)

    February 21-22, 2018 – Advanced Summit on Life Sciences Patents (American Conference Institute) – New York, NY

    March 5-6, 2018 – Advanced Patent Law Seminar (Chisum Patent Academy) – Houston, TX

    March 8-9, 2018 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH