• Genus PLC v. Inguran, LLCInstituted
  PTAB · Dec 14, 2021 · IPR2021-01027 · APJ Ulrike W Jenks · IPR · Institution

  The Board instituted IPR of claims 1–5 on all three grounds, finding a reasonable likelihood that at least one challenged claim would be anticipated or obvious.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “determine whether to institute an inter partes review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a)(2020). Inter partes review may not be instituted unless “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Supreme Court held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art would have had at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine” and “would have been well-acquainted with methods of commercial breeding of lines and breeds within a genetic nucleus for the purpose of promoting genetic progress, the use of sex-selected semen in breeding schemes, including those within the genetic nucleus, genetic evaluation of livestock for desirable and undesirable traits, and the use of genetic markers, e.g., SNPs, and various other genotype data, to guide selection strategies to 1 The relevant sections of the Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125 Stat. 284 (Sept. 16, 2011), took effect on March 16, 2013. Because the priority application from which the ’734 patent issued was filed before that date, our citations to Title 35 are to its pre-AIA version. 2 Petitioner contends that claims 1–5 are anticipated by Dekkers, as evidenced by either Maxwell, Garner, or Kim. Pet. 26–41. Alternatively, Petitioner contends that claims 1–5 are obvious over Dekkers and either Maxwell, Garner, or Kim. Pet. 41–45. 3 In the table identifying ground III, Petitioner does not list Kim. Pet. 4. However, in the arguments provided for this ground in regard to claim 5, Petitioner includes Kim. Pet. 48. improve desirable traits and/or minimize undesirable traits.” Pet. 13 (citing Ex. 1002 ¶ 22). Patent Owner states, “[s]olely for purposes of this Preliminary Response, Patent Owner and its expert apply this portion of Petitioner’s proposal, while reserving the right to dispute it later.” Prelim. Resp. 17. On this record, we adopt Petitioner’s definition of the level of ordinary skill in the art as Patent Owner also does. We also note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). B. Principles of Law” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “would not find the additional language in Petitioner’s proposed definition accurate in describing a genetic nucleus. Prelim Resp. 21 (citing Ex. 2001 ¶ 21). Patent Owner contends “that the plain and ordinary meaning of ‘genetic nucleus’ is ‘an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy of herds in a commercial herd breeding structure.’” Id. (citing Ex. 2001 ¶ 24 (“The ’734 Patent does not specify this additional requirement as part of the meaning of ‘genetic nucleus,’ nor would the additional language be accurate in describing every genetic nucleus.”). On the present record, Petitioner has the better argument. The ’734 specification describes pig breeding as pyramid with the “nucleus herd” at the top of the pyramid and commercial farms at the bottom. Ex. 1001, 9:43– 44. “A nucleus herd is typically comprised of 12 to 15 lines, although any number of lines may be represented, with each line comprising a number of desirable traits. . . . Only the offspring with the highest measured selection index are retained in the nucleus herd.” Id. at 9:47–49. The retention of offspring with the most desirable features in the nucleus herd reasonably implies that these individuals are selected to propagate the desirable trait in the nucleus heard. Accordingly, at this stage of the proceeding, we construe “genetic nucleus” as “an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy of herds in a commercial herd breeding structure, wherein certain offspring of the herd are used for breeding within the herd.”” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “the context of artificial insemination for the purpose of directing piglet production toward creating predominantly male or female offspring. Petitioner’s expert explains that the state of the art at the time the invention was made required at least an 80% or better sex sorted semen in order to be able to use the sorted semen in to skew the piglet production in a littler to be either predominantly female or male offspring. See Ex. 1002 ¶ 113. Specifically, Petitioner’s expert avers that one of ordinary skill in the art would have understood that “[f]rom a commercial pig production perspective, using semen with less than 80% sex skew (i.e., purity for X or Y chromosomes) would not be efficient or economical, and consumers (e.g., pig producers) would not purchase such poorly enriched samples.” Ex. 1002 ¶ 113. Petitioner’s expert testimony is supported by the teachings of Maxwell (Ex. 1005) and Garner (Ex. 1006), both of which are expressly cited in Dekkers as evidencing “sperm sexing technology . . . for the production of either male or female offspring for sire or dam lines.” See Ex. 1004, 396, 420, 422. In particular, Maxwell teaches that “[i]n combination with the orientating nozzle and changes in the design of the sorter electronics, this allowed significant increases in sorting rates (15 million spermatozoa per hour) to be achieved while maintaining more than 85% purity.” Ex. 1005, 81. In addition, Gardner teaches that “acceptable sperm sexing efficiency, usually at 90% accuracy.” Ex. 1006, Abstract. Based on the current record, Petitioner’s expert testimony reasonably supports the position that Dekkers application of sex sorting technology at the level of the nucleus or multiplication tiers would require at least an 80% sex sorting efficiency. Patent Owner contends that Petitioner is improperly relying on Maxwell and Garner in order to support its anticipation argument over Dekkers. Prelim. Resp. 26 (citing Callaway Golf Col. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed. Cir. 2009)). On the record at the stage of the proceeding, Petitioner has made an adequate showing to supports its anticipation argument. In particular, Dekkers disclosure of using sex sorted semen to allow for the production of either male or female offspring for sire or dam lines, reasonably suggests that the sorted sperm is at a sufficient purity level to achieve the stated result. Ex. 1004, 396. Petitioner relies on the testimony of its expert to establish that at the time the invention was made one of ordinary skill in the art would have understood that 80% or better sex sorted semen is a necessary level in order to skew the sex of the litter. See Ex. 1002 ¶ 113. Here, Petitioner’s expert testimony is supported by the teachings of either Maxwell (Ex. 1005) or Garner (Ex. 1006) to establish the knowledge of one of ordinary skill in the art at the time of Dekkers publication. Accordingly, we are not persuaded by Patent Owner’s contention that Petitioner is improperly relying on Maxwell and Garner. Accordingly, having considered the arguments and evidence presented by the parties at this stage, Petitioner has made a sufficient showing that Dekkers discloses the claim limitations of element 1c.” slip op. at 25

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,542,734
• Neurocrine Biosciences, Inc. v. Spruce Bosciences, Inc.Institution denied
  PTAB · Dec 10, 2021 · PGR2021-00088 · APJ John G New · PGR · Institution

  The Board denied institution on all five grounds, finding the petition did not show any challenged claim was likely unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon consideration of the Petition, the Preliminary Response, and the evidence presently before us, we determine that Petitioner has failed to demonstrate that it is more likely than not that it would prevail in establishing the unpatentability of at least one challenged claim of the ’908 patent. We consequently deny institution of post-grant review.” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001 col. 42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 8

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “likely than not that independent claims 1 and 11 are anticipated by Grigoriadis. “For a claim to be anticipated, each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed, either expressly or inherently, in that same prior art reference.” Therasense, Inc. v. Becton, Dickinson and Co., 593 F.3d 1325, 1332–33 (Fed. Cir. 2010). The single clinical trial taught by Example 6 of Grigoriadis does not establish a baseline value for patients against which to compare the data obtained from patients receiving 300 mg or 600 mg of the test drug, NBI- 77860 (verucerfont). See Ex. 1006 ¶¶ 90–94. Specifically, Example 6 does not establish a baseline “which include[s] an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose,” as disclosed by the ’908 patent. See Ex. 1001, col. 42, ll. 12–16. We therefore conclude that Grigoriadis fails to disclose expressly the limitations of claims 1 and 11 severally reciting “wherein [the] … hormone … level in the human is reduced by at least 10 % from baseline.”” slip op. at 16

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

    “A reference may anticipate if a claim limitation that is not expressly disclosed is inherently disclosed because it “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010); see also Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (holding that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question”).” slip op. at 17

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,849,908
• Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd.All claims unpatentable
  PTAB · Dec 7, 2021 · IPR2020-01053 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–75 are unpatentable as obvious over Saji; the Board did not reach the Latuda Information anticipation and Latuda Information–Loebel obviousness grounds.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Indeed, as Patent Owner acknowledges, the parties’ proposed definitions of the ordinary skill level do “not differ significantly.” Id. at 25. Nevertheless, for purposes of this Decision, we adopt Patent Owner’s definition of the skill level, as it is consistent with the ’827 patent disclosures and the prior art of record, and more inclusively describes the suitable experience for one of ordinary skill in the art.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “On this record, we find Petitioner’s proposed constructions are supported by intrinsic and extrinsic evidence. See Pet. 18–23. We agree with Petitioner here that “a patient” or “the patient” should have its ordinary and customary meaning of “one or more patients,” as opposed to a “patient population” as Patent Owner has previously argued in a district court litigation involving another party. See id. at 19–20. Indeed, Patent Owner agrees. See Reply 19 (“There is no dispute that ‘a patient,’ as recited in the ’827 claims, refers to ‘one or more patients.’”).” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “On this record and for purposes of this Decision, we see no need to construe any other term expressly. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “Based on Saji’s preferred dose range of 5 to 100 mg/day, which overlaps with the “from 20 to 120 mg/day” range required by each challenged independent claim, Petitioner argues that an ordinarily skilled artisan would have been “motivated to conduct dose ranging studies and would find the claimed dosing regimens.” Pet. 62; see also id. at 55 (contending that “dose ranging was a routine part of drug development” (citing Ex. 1030)). Dr. Stahl’s testimony supports Petitioner’s argument. Indeed, Dr. Stahl testifies that, although with some drugs, it can be difficult to find a safe and effective dose, or to get an effective dose into the patient, neither is the case with lurasidone. Ex. 1054, 141:3–14; see also id. at 142:2–6 (“Q. [A]re you aware of any particular difficulties with lurasidone hydrochloride and finding a safe and effective dose for schizophrenia and manic depressive psychosis? A. No.”); 135:18–25 19 (Dr. Stahl testifying that he is “not aware of anything unusual about [lurasidone’s] dose range”). Thus, we agree with Petitioner that an ordinarily skilled artisan, starting from Saji’s preferred dosing range, would have conducted routine dose ranging studies and identified the claimed dosing regimens.” slip op. at 19

  Patent outcomesUS 9,815,827 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,815,827
• Collegium Pharmaceutical, Inc. v. Purdue Pharma L.P., Purdue Pharmaceuticals L.P., And The P.F. Laboratories Inc.All claims unpatentable
  PTAB · Nov 19, 2021 · PGR2018-00048 · APJ Devon Zastrow Newman · PGR · Final written decision

  Claims 1–17 are unpatentable for lack of written description and anticipation by the ’943 Publication; indefiniteness and lack of enablement were not shown.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “We are not persuaded that exclusion of the cited portions of Dr. Chambliss’ testimony or Exhibits 1073, 1074, 1075, 1082, 1083, 1084, 1085, 1086, 1088, and 1090 is warranted. While the parties disagree on the merits of Dr. Chambliss’ testimony as to whether PGGs were known to be gelling agents by persons of ordinary skill in the art at the time of the Priority Applications, Patent Owner does not persuade us that Dr. Chambliss fails to support his testimony with any reasonable logical or scientific basis. The exhibits that Patent Owner seeks to exclude, which include a patent, technical references, and a journal article, are relevant to the inquiry Dr. Chambliss performed in forming his opinion. We therefore do not see a basis for exclusion under FRE 702/703 or 37 C.F.R. § 42.64(c). Moreover, we find this evidence both admissible and relevant as it concerns a fundamental issue for our patentability analysis. Thus, we decline to exclude the evidence under FRE 401 or 402.” slip op. at 12

  • Skill levelSkill level petitioner adoptedOther

    “would have possessed “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, and/or pharmacology and a number of years of industry training or experience in one or more of those fields.” Pet. 21 (citing Ex. 1002 ¶ 82). Petitioner further proposes that “[i]f the degree is a Ph.D[.], then the required industry experience need not be significant, e.g., two years or more, but if the technical degree is a B.S. or M.S., then the industry experience would be more significant, e.g., five years or more.” Id. We preliminarily adopted Petitioner’s definition of a POSA’s skill level in our Institution Decision as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Neither Patent Owner nor Petitioner addresses the level of ordinary skill in the art in the post-institution briefing. We continue to adopt Petitioner’s proposed skill level for a POSA herein and have also taken into account the level of skill reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Applying this level of skill, we find that Dr. Chambliss and Dr. Constantinides are qualified to provide opinions as to the perspective and knowledge of a POSA. See Ex. 1002 ¶¶ 81–83; Ex. 2030 ¶¶ 58–63.” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We agree with Patent Owner that the challenged claims recite methods of making formulations using recited features and ingredients. In addition, as we stated in our Decision on Institution, “[t]he claims define abuse deterrence in terms of when the dosage form is ‘subjected to t[a]mpering comprising heating at a temperature greater than about 45° C.’” Inst. Dec. 19 (quoting Ex. 1001, 41:50–52). Additionally, the claims and specification identify specific ingredients that can purportedly help achieve this abuse deterrence functionality. Id. Given these conclusions, further construction of “abuse deterrent,” which both parties generally agree relates to methods of making the drug dosage form less likely to be abused, is not necessary to resolve the issues before us.” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “Notwithstanding these individual teachings, we find that the specification fails to demonstrate that the inventors of the ’961 patent possessed a dosage form comprising a combination of the recited components that also satisfied the recited functionality. We are persuaded that the specification fails to provide sufficient guidance that would have led the POSA to create the recited dosage form. See Fujikawan 93 F.3d at 1571; In re Ruschig, 379 F.2d 990, 995 (CCPA 1967). Rather, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” Ruschig, 379 F.2d at 995.” slip op. at 34

  Patent outcomesUS 9,693,961 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites Nautilus
  Patents in suitUS 9,693,961
• Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.Instituted
  PTAB · Nov 10, 2021 · IPR2021-00880 · APJ John G New · IPR · Institution

  The Board instituted inter partes review on all challenged claims and grounds, finding a reasonable likelihood that claims 1 and 9–12 are anticipated by Dixon or Heier 2009.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “Becton-Dickinson factors (a), (b), and (d) have been satisfied. The evidence of record shows that the Dixon reference before the Examiner consisted of merely the first page of Dixon. See Ex. 1087. The single page of Dixon that 8 Thomas Reuters Integrity, VEGF Trap-Eye Final Phase II Results in Age-Related Macular Degeneration Presented at 2008 Retina Society Meeting, (Sep. 28, 2008). Ex. 2007. was before the Examiner provides no disclosure of the claimed dosing regimen. It would consequently have been impossible for the Examiner to analyze the limitations of the challenged claims in view of the complete teachings of Dixon under these circumstances. We consequently find that the disclosure of Dixon that form the basis of Petitioner’s Grounds I and IV (of which Dixon is the sole reference) were not before the Examiner as prior art during examination (because the relevant disclosures were missing or omitted), and that there could therefore be no overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art.” slip op. at 12

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “c. Analysis We conclude that Petitioner has established a reasonable likelihood of success in prevailing at trial on Grounds 1 and 2, and that Patent Owner’s arguments are insufficient, based upon the current record, to overcome that likelihood of success. Petitioner’s claim chart maps out the correspondence between the limitations of claim 1 and the disclosures of Dixon and Heier 2009 in a manner that persuasively demonstrates that the disclosures of both references disclose all of the limitations. Patent Owner does not dispute Petitioner’s showing that the references anticipate, with three exceptions. We address each of those arguments in turn.” slip op. at 30

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted

    “Ex. 1006, 4 (emphasis added). Dixon thus expressly discloses that patients were treated on a “p.r.n. basis” (i.e., an “as needed basis”) for additional doses, and details the criteria by which the physical symptoms were assessed to determine whether another dose was warranted. It is true that Dixon does not expressly state that it is a physician who performs this assessment of the patient in question. But we find that a person of ordinary skill in the art, as defined by Petitioner, would understand that the preforming of diagnostic procedures and analysis, and the prescription of the appropriate medication, would necessarily need to be performed by a physician or other qualified medical professional licensed by 12 Patent Owner also argues that, contra Petitioner’s assertion, this limitation is a positive limitation of the claim that should be afforded patentable weight. See Prelim. Resp. 20–24. For the purposes of this Decision, we accept Patent Owner’s contention that the limitation reciting “assessed by a physician or other qualified medical professional” is entitled to patentable weight. As we explain, however, Patent Owner’s argument that this limitation is not disclosed by the cited prior art is unpersuasive. the state. That is, almost by definition, the practice of medicine, and is certainly well known in this art. See In re Graves, 69 F.3d 1147, 1152 (Fed. Cir. 1995) (holding that the teachings of a reference may be taken in combination with knowledge of the skilled artisan to put the artisan in possession of the claimed invention within 35 U.S.C. § 102 even though the patent does not specifically disclose certain features); see also Continental Can, 948 F.2d at 1269 (holding that anticipation requirement that every element of a claim appears in a single reference accommodates situations where the common knowledge of “technologists” is not recorded in a reference, i.e., where technical facts are known to those in the field of the invention). We therefore find that a person of ordinary skill in the art, as defined by Petitioner, would understand that only a licensed physician could competently perform the procedures disclosed by Dixon in the quoted passage.” slip op. at 31

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (1) developing treatments for angiogenic eye disorders (such as AMD), including through the use of VEGF antagonists, or (2) treating of angiogenic eye disorders (such as age-related macular degeneration (“AMD”)), including through the use of VEGF antagonists. Pet. 25 (citing Ex.1002 ¶¶ 26–28). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Preliminary Response, although Patent Owner contends that such a skilled artisan could not necessarily perform the limitation of claim 1 reciting “based on visual and/or anatomical outcomes as assessed by a physician or other qualified medical professional.” See, e.g., Prelim. Resp. 28. We address Patent Owner’s contentions with respect to this limitation in our analysis below. For the purposes of this decision, because we find Petitioner’s definition to be consistent with the level of skill in the art (see, e.g., Exs. 1006, 1020), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we consequently adopt Petitioner’s definition.” slip op. at 8

  § 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips
  Patents in suitUS 9,669,069
• Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.Instituted
  PTAB · Nov 10, 2021 · IPR2021-00881 · APJ Erica A Franklin · IPR · Institution

  The Board instituted IPR on claims 1, 3–11, 13, 14, 16–24, and 26 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

    “during the prosecution of the ’338 patent, the Examiner was presented with the information disclosed in the 2008 Press Release for “VEGF Trap-Eye final phase II results in age-related macular degeneration presented at 2008 Retina Society Meeting.” Applicant included the Thomson Reuters description of the press release on the IDS, Ex. 1017, 60–61, along with the submission of the Thomson Reuters publication, Ex. 2007, referenced therein. The Thomson Reuters publication expressly identified the press release by name and date as the “Reference” for the information described in the publication, as well as by the title of the press release. Ex. 2007. Importantly, the Thomson Reuters publication also provided a summary description of the contents of the press release, in a form that resembles an abstract. The contents of the Thomson Reuters publication provides the regimen for VEGF Trap-Eye as each of the cited references relied upon by Petitioner for its anticipation and obviousness challenges.” slip op. at 13

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “review. 35 U.S.C. § 314 (2018). Upon considering the parties’ arguments and evidence, we determine that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1, 3–11, 13, 14, 16–24, and 26 of the ’338 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art at the time of the invention would have had (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field, including the publications discussed herein. Typically, such a person would have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders (such as AMD), including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists.” slip op. at 15

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “the current record, that the preamble reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioner that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” the Federal Circuit has recently articulated that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Indeed, the Federal Circuit reiterated that “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we determine whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)). With that said, the Court explained that “while there is no bright-line rule, it is instructive that this court has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Id. at 1342. a VEGF antagonist for the specific purpose of treating an angiogenic eye disorder in a patient. The Specification repeatedly characterizes the method as one that is useful for treating angiogenic eye disorders in patients. See Ex. 1001, 1: 18–20, 63–66, 2:23–27; 3:19–20; 5:11–13. Apart from the preamble, the independent claims do not elsewhere recite or indicate the usefulness of the method steps. Thus, we agree with Patent Owner that the preamble sets forth the essence of the invention. Prelim. Resp. 32. In Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339 (Fed. Cir. 2003), the Federal Circuit explained that “preamble language will limit the claim if it recites not merely a context in which the invention may be used, but the essence of the invention without which performance of the recited steps is nothing but an academic exercise,” and that this principle frequently holds true for method claims. Id. at 1345 (citing Griffin v. Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002)). We also agree with Patent Owner that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claims, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Prelim. Resp. 34–35. As Patent Owner asserts, without the preamble, it would be unclear to whom the doses of VEGF are administered. See id. at 35. Thus, in view of Federal Circuit case law regarding statements of intended purpose in claims directed to method of using compositions, and in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we preliminarily find that the preambles of claims 1 and 14 are limiting.” slip op. at 18

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 9,254,338
• Eis GmbH v. Novoluto GmbHNo claims unpatentable
  PTAB · Sep 23, 2021 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–3, 5, 7, 8, 11, 14, 15, and 17–26 were not shown unpatentable under the Taylor anticipation or Taylor-based obviousness grounds.

  RulingsFinal written decision

  • Expert testimonyPatent owner expert creditedDenied

    “disclosure of a suction cup “sealingly” receiving the vulva occurs when the vacuum is applied, not before. See Ex. 2034 ¶ 121. We disagree with Petitioner’s conclusion that “Taylor discloses that arm 26 ‘compresses . . . and then expands bellows 160’ after member 156 ‘sealingly’ engages the vulva.” Reply 9. The single statement in Taylor on which Petitioner relies states, with reference to Figure 3 set forth above in Section II.D.1, “[t]he first stimulator 154 includes a suction cup member 156 that conformingly and sealingly receives the upper portion of the vulva.” Ex. 1004, 5:29–31. We agree with Dr. Jensen that this does not support Petitioner’s conclusion that a seal is achieved before the vacuum is applied, and credit Dr. Jensen’s testimony that reads as follows as consistent with Taylor’s disclosure.” slip op. at 35

  • ExcludeMotion to exclude, deniedDenied

    “5. Conclusion For the reasons set forth above, we deny the portion of Petitioner’s” slip op. at 73

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “7 Petitioner presents argument that the term “pressure field generator” should be construed as a means-plus-function term limited to the following structure: at least one first chamber, at least one second chamber, and at least one connection element. Reply 25–26. As we find that it is not necessary to construe this term to resolve the issues before us, we do not address these arguments presented by Petitioner.” slip op. at 17

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “disclosure of a suction cup “sealingly” receiving the vulva occurs when the vacuum is applied, not before. See Ex. 2034 ¶ 121. We disagree with Petitioner’s conclusion that “Taylor discloses that arm 26 ‘compresses . . . and then expands bellows 160’ after member 156 ‘sealingly’ engages the vulva.” Reply 9. The single statement in Taylor on which Petitioner relies states, with reference to Figure 3 set forth above in Section II.D.1, “[t]he first stimulator 154 includes a suction cup member 156 that conformingly and sealingly receives the upper portion of the vulva.” Ex. 1004, 5:29–31. We agree with Dr. Jensen that this does not support Petitioner’s conclusion that a seal is achieved before the vacuum is applied, and credit Dr. Jensen’s testimony that reads as follows as consistent with Taylor’s disclosure.” slip op. at 35

  Patent outcomesUS 9,849,061 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,849,061
• Triplet Therapeutics, Inc. v. Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical CollegeInstitution denied
  PTAB · Sep 8, 2021 · PGR2021-00059 · APJ Devon Zastrow Newman · PGR · Institution

  The Board denied institution on claims 1–15: grounds 2–5 lacked a supported reason to combine, and ground 1 repeated arguments considered by the Office.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “We have the authority and discretion to determine whether to institute a post grant review. 35 U.S.C. § 324; 37 C.F.R. § 42.4(a) (2021). We may not institute a post-grant review unless “the information presented in the petition . . . , if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). After considering the briefing and the evidence of record, we conclude that Petitioner has failed to establish a reasonable likelihood of prevailing in demonstrating that the challenged claims are unpatentable over the cited prior art in asserted grounds 2–5. With regard to ground 1, Petitioner’s written description ground, we determine that Petitioner’s arguments are substantially the same as those previously presented to and considered by the Office, and we exercise our discretion under 35 U.S.C. § 325(d) and decline to institute post-grant review of the ’542 patent on that ground alone.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “We agree with Patent Owner that Petitioner’s arguments regarding whether the ’542 patent provides § 112 written description support for the challenged claims are substantially the same as those considered by the Examiner during the prosecution of the ’542 patent. As set forth above, the Examiner repeatedly rejected the pending claims because (1) the claims were overly broad in light of the guidance provided in the specification that was limited to the working examples specific to exon 7 of a gene encoding a MLH3 subunit (Ex. 1006, 623–24); (2) the claims did not enable the oligonucleotides to “hybridize[] to a complementary target nucleic acid sequence of a gene or gene product to modulate the expression of a component of a mismatch repair (MMR) complex” based on the disclosure of the specification, which was limited to the working examples (id.); and (3) the claims did not enable a pharmaceutical composition of the recited nucleotide base length range for the entire scope of the claims based on the disclosure of the specification, which was limited to the working examples (id. at 1183–84). The rejections were based on a broad reading of the claims as interpreted by the ordinarily skilled artisan, and required analysis of whether there is sufficient support in the specification for the entire scope of the claims. Applicant overcame these issues by narrowing the claims until the Examiner agreed that the support present was sufficient.” slip op. at 36

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not found

    “We agree with Patent Owner that Petitioner’s allegations regarding the skilled artisan’s reasons to combine are conclusory and insufficiently supported by evidence. Petitioner cites Dr. Wood’s testimony to explain why the skilled artisan would have understood that Fuselier’s suggestion to “switch[] isoforms of MLH3” could be accomplished by manipulating pre-mRNA splicing to delete exon 7. Petitioner’s discussion on pages 59–60 quotes phrases from Dr. Wood’s referenced testimony, see Ex. 1002, ¶¶ 213–216, but the rationale appearing in the Petition merely comprises repetitive generalized statements akin to “Morcos is a powerful tool that can accomplish what Fuselier suggested.” See Pet. 59–60. Dr. Wood’s underlying testimony lacks key explanation as to the understanding of the ordinary artisan at the time of the invention. What Petitioner has not provided, as Patent Owner argues, are the reasons 1) why Fuselier’s suggestion to “switch[] isoforms” would have led the artisan to pursue deletion of exon 7; and 2) why the artisan would have selected Morcos’ time. See Prelim. Resp. 55–56.” slip op. at 19

  • Skill levelSkill level petitioner adoptedOther

    “invention in the field of antisense technology “would have had knowledge of the scientific literature and have skills relating to approaches for utilizing synthetic oligonucleotides to manipulate gene expression” and “have been well-experienced in laboratory techniques and strategies for designing and making SSOs, conducting in vitro and in vivo testing, and application of SSOs in research.” Pet. 18 (citing Ex. 1002 ¶¶ 30, 31). Petitioner adds that the artisan “would have had knowledge of laboratory techniques and strategies in creating nuclease-resistant SSOs, and using such SSOs to manipulate gene expression to force expression of selected isoforms of a M.D. or a Ph.D. in physiological science, biochemistry, molecular biology, chemistry, or a related discipline, with at least five years of experience in SSOs design and manipulation” and may have “worked as part of a multidisciplinary team” to permit input by others on the team with specialized skills to assist in solving problems. Id. Patent Owner does not contest the skill level provided by Petitioner for the purpose of deciding institution (Prelim. Resp. 4), and we adopt it as reasonably consistent with the level of skill represented by the ’542 patent and the art of record.” slip op. at 8

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 10,669,542
• Syngenta Crop Protection AG v. FMC CorporationSome claims unpatentable
  PTAB · Aug 31, 2021 · PGR2020-00028 · APJ Cynthia M Hardman · PGR · Final written decision

  Claims 1–3, 9–13, and 21–30 are unpatentable for lack of enablement; claims 9–13 also lack written description. Petitioner did not prove anticipation or obviousness of claims 1–7 and 22–31.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of skill in the art, we consider factors including the type of problems encountered in the art, prior art solutions to those problems, and the sophistication of the technology. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Because Petitioner’s proposed definition is consistent with the prior art of record and the sophistication of the technology demonstrated by the record, we apply it here.5” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Based on the complete record developed at trial, we determine that to resolve the disputes herein, we do not need to expressly construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that construction is needed only for disputed terms, and only as necessary to resolve the controversy).” slip op. at 11

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We find that Dr. Dayan’s testimony on these points lacks sufficient supporting analysis. In opining that the tested substituents are representative of the steric and electrostatic properties across the claimed substituents, Dr. Dayan merely compares the properties of the tested substituents to each other. See, e.g., id. ¶¶ 52–56. He does not expressly compare them to the properties of the many remaining, untested substituents within the scope of the claims. See id.; see also Reply 14 (“At best, [Dr.] Dayan testified that the positive activity . . . at each substituent” suggests that the position is involved in herbicidal activity, “not that the tested compounds were sufficient to provide any reasonable expectation of success as to the billions of structurally diverse compounds covered” by the claims.). And although Dr. Dayan acknowledges that several tested compounds showed no herbicidal activity, he does not expressly explain how he took these compounds into account in nevertheless concluding that an ordinarily skilled artisan would expect at least some activity across all claimed substituents. See, e.g., Ex. 2011 ¶¶ 54–56 (noting exceptions to herbicidal activity). As one example, Dr. Dayan acknowledges the lack of activity shown in the data for substituents larger than hydrogen at the R6 position, but does not explain the impact of that data on the remaining claimed substituents. See id. ¶ 54 (Dr. Dayan noting that activity is “not as favored by larger alkyl groups” at R6, but nevertheless concluding that “one would expect at least some herbicidal activity” across all claimed R6 substituents). In contrast, Dr. Hunt compares the size and properties of the R6 substituents that showed no activity with the size and properties of other claimed but untested R6 substituents. Ex. 1003 ¶¶ 163, 166–68; Ex. 1029 ¶¶ 37, 38. This comparison indicates that the majority of R6 substituents are larger than the tested substituents, such that the vast majority of the claimed compounds (i.e., those with compounds having R6 substituents larger than those tested), could have no herbicidal activity. Ex. 1003 ¶ 167; Ex. 1029 ¶¶ 12, 37, 38. Thus, we find that the data in the Specification regarding at least position R6 gives a person of ordinary skill in the art reason to doubt that substantially all compounds within the full scope of claim 1 of the ’202 patent would exhibit herbicidal activity. Ex. 1003 ¶ 163; Ex. 1029 ¶¶ 11, 12, 38; In re Surrey, 370 F.2d 349, 355 (CCPA 1966) (“[W]here the applicant seeks to obtain a monopoly in exchange for his disclosure of a group of compounds there should be a disclosure which gives a reasonable assurance that all, or substantially all of them are useful.”).” slip op. at 29

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “We find that the need for iterative QSAR modeling, together with the sheer number of candidate compositions that must be synthesized (each of which would take at least a week to make) for both the modeling and herbicide testing, weighs against enablement, especially in light of the limited guidance in the Specification and the general unpredictability in the art. 3. Conclusion In sum, it is undisputed that claim 1 covers at least a billion compounds. The art is unpredictable, and the Specification indicates that not all of the compounds falling within claim 1 are effective herbicides. See, e.g., Pet. 22 (listing compounds that showed no herbicidal activity). Although the level of ordinary skill in the art is relatively high and the field is mature, Petitioner establishes by a preponderance of the evidence that the ’202 patent does not provide sufficient meaningful guidance or working examples across the full scope of claim 1 to allow a person of ordinary skill in the art to determine which other compounds across the full scope of the claim have herbicidal activity without undue experimentation.” slip op. at 45

  Patent outcomesUS 10,294,202 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 10,294,202
• Fresenius Kabi USA, LLC / Fresenius Kabi Swissbiosim GmbH v. Coherus Biosciences, Inc.Rehearing denied
  PTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing

  The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable

    “These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7

  Claim construction§ 112 disclosure
  Patents in suitUS 10,155,039

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.