• Avation Medical, Inc. v. Emkinetics, Inc.Instituted
  PTAB · Jan 29, 2025 · PGR2024-00043 · APJ John G New · PGR · Institution

  The Board instituted PGR on all challenged claims, finding a sufficient likelihood that claims are anticipated or obvious under Grounds 1–10; it found Ground 11’s enablement challenge insufficient.

  RulingsInstitution decision

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

    “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.” For the reasons we explain below, we institute post-grant review of the ’943 patent.” slip op. at 2

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “asserted reference qualifies as prior art is public accessibility. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 15

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner

    “priority benefit of the ’720 provisional application (at top center). See Ex. 1001, code (60) (listing “provisional application No. 5,995,873, filed on Oct. 2, 2006”). However, simply to claim the priority benefit of an earlier application is not necessarily to receive it. See In re NTP, Inc., 654 F.3d 1268, 1276 (Fed. Cir. 2011) (holding that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority.… Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120.”). As the diagram shows (and as we have verified), the ’529 application was a continuation-in-part of the preceding ’329 application. See Ex. 1001, code (63). However, the ’529 application was abandoned on February 10, 2016 (See Ex. 1052), and the succeeding application, U.S. Patent Application Ser. No. 15,474,875 (the “’875 application”) which is listed in the ’943 patent as being a continuation-in-part of the ’529 application, was not filed until March 30, 2017. See Ex. 1001, code (63) (stating that “said application No. 15/474,875 is a continuation-in-part of application No. 12/508,529”). Put simply, the ’875 application was not filed until over a year after the ’529 application was abandoned. As 35 U.S.C. § 120 states, in relevant part: An application for patent for an invention disclosed in the manner provided by section 112(a) (other than the requirement to disclose the best mode) in an application previously filed in the United States, or as provided by section 363 or 385, which names an inventor or joint inventor in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application. (emphasis added). In other words, if there is a “break in the chain” of priority caused by the abandonment or termination of an application claiming priority prior to filing of a subsequent application, the subsequent application loses the priority benefit of the abandoned or terminated application, as well as the priority benefit of all applications that antedate that abandoned or terminated application. Such is the case presently before us. Based on the current record, we are persuaded that the abandonment of the ’529 application prior to filing of the continuation-in-part ’875 application broke the priority chain leading to the ’720 provisional application, and the ’943 patent cannot, therefore, claim the priority benefit of the ’720 provisional application’s October 2, 2006 filing date. Consequently, the earliest date of which the ’943 patent could possibly claim the priority benefit is that of U.S. Patent Provisional Application Ser. No. 61/403,680 (the “’680 provisional application”) (located at the top of the left branch of the “family tree” depicted above), which has a filing date of September 20, 2010. See Ex. 1001, code (60). Burnett (i.e., the ’329 application) was filed on October 2, 2007 and thus antedates the ’680 provisional application. Consequently, Patent Owner’s argument fails based on the current record, and Burnett is prior art to the ’943 patent.” slip op. at 55

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

    “Patent Owner’s request that we exercise our discretion under § 325(d) is not tenable. In deciding whether to exercise our discretion under § 325(d) in situations where only some of the challenges fall within its scope, we evaluate the challenges and determine whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting on all challenges. If so, the panel will evaluate whether the entire petition should be denied.” See USPTO, SAS Q&As (June 5, 2018) at D1, available at: https://www.uspto.gov/sites/default/files/ documents/ sas_qas_20180605.pdf; see also Kansas State Univ. Res. Found., PGR2022- 00021, Paper 11 at 7–8 & n.3 (Vidal Feb. 24, 2023) (holding that “the Board will further evaluate … whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting review on all challenges presented in the Petition”). We having instituted post grant review based at least upon claim 1 of Ground 1 of the Petition. Even if the panel agreed with Patent Owner that Grounds 5–8 present “the same or substantially the same prior art or arguments” previously presented to the Office, § 325(d) would not be “sufficiently implicated” due to the 7 other asserted grounds. We therefore do not proceed with the § 325(d) analysis established in Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) and decline to exercise our discretion to deny the petition on that basis.” slip op. at 41

  Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips · KSR
  Patents in suitUS 11,844,943
• Catalyst Orthoscience Inc. v. Shoulder Innovations, Inc.Institution denied
  PTAB · Dec 19, 2024 · PGR2024-00042 · APJ Lisa L Tsang · PGR · Institution

  The Board denied institution of PGR challenging claims 1–16, finding the first five Fintiv factors favored denial and the petition did not present compelling merits.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

    “during the conference and in the Minute Entry, and in the court’s subsequent Order Regarding Schedule. We also note that the evidence shows the district court may intend to reschedule the trial to a date substantially earlier than March 9, 2026. See Ex. 2010, 5; Ex. 1029, 10−11. However, given that the Order does not unambiguously set a trial date for December 1, 2025, or even sometime in December 2025 or January 2026 (see Ex. 1028), we decline to speculate as to what date the court may ultimately select for trial. Moreover, the record shows that Petitioner has consistently opposed moving the trial to a date earlier than March 9, 2026. See Ex. 2010, 5; Ex. 1026, 2−4; Ex. 1029, 11. We view Petitioner’s opposition as creating yet more ambiguity as to the trial date in the co-pending litigation. Therefore, we find that factor 2 is neutral because the exact trial date in district court is uncertain.” slip op. at 14

  • BurdenNot reached

    “if unrebutted in trial, would plainly lead to a conclusion that one or more claims are unpatentable by a preponderance of the evidence.” Guidance Memo 4. This standard is only met “if it is highly likely that the petitioner would prevail with respect to at least one challenged claim.” OpenSky Indus., LLC v. VLSI Tech. LLC, IPR2021-01064, Paper 102 at 49 (Vidal Oct. 4, 2022) (precedential) (citing Guidance Memo 4). We have reviewed Petitioner’s challenges and Patent Owner’s arguments. For the reasons explained below, we determine that Petitioner’s challenges have not risen to the threshold of compelling merits. Before addressing the parties’ arguments regarding the asserted grounds, we address: (a) the level of ordinary skill in the art, (b) claim construction, and (c) relevant principles of law; and we provide (d) overviews of the asserted art.” slip op. at 18

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We agree with Patent Owner that its proffered additional level of ordinary skill in the art appears consistent with the experience Petitioner describes. See Pet. 16. For purposes of this Decision, we adopt the level of ordinary skill in the art articulated by Petitioner and supplemented by Patent Owner, because, based on the current record, it is consistent with our review and understanding of the technology and descriptions in the ’561 patent and prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). We note, however, that the open-ended language “at least” expands the range of education and experience indefinitely with no upper bound. Therefore, we do not adopt this aspect of Petitioner’s formulation.” slip op. at 19

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “In this regard, Mr. Fallin testifies that I have decades of experience working directly with joint replacement systems, including hip joint replacement systems, knee replacement systems, and facet joint replacement systems. My work on these joint replacement systems included my direct engagement or supervision of and professionals in the inventing, designing, fabricating, testing, obtaining regulatory approvals, ensuring regulatory compliance, commercializing, and patenting of these systems. Ex. 1002 ¶ 10. Mr. Fallin also testifies that his experience “includes working directly with supervising professionals whose responsibilities included designing, developing, and commercializing joint replacement systems and similar device[s].” Id. ¶ 67 As such, Mr. Fallin identifies “decades” of experience with joint replacement systems. Ex. 1002 ¶ 10. Moreover, Patent Owner does not persuasively explain why Mr. Fallin’s “direct engagement” and “working directly with,” as well as “supervision” of, other individuals designing joint replacement systems, does not at least imply personal design experience. See Prelim. Resp. 10–11. Therefore, we determine that the current record reflects that Mr. Fallin is qualified to testify as to the knowledge of a person of ordinary skill in the art.” slip op. at 20

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 11,771,561
• MPL Brands NV, Inc. v. Buzzballz, LLCInstituted
  PTAB · Dec 18, 2024 · PGR2024-00035 · APJ Cynthia M Hardman · PGR · Institution

  The Board instituted PGR on all asserted grounds after finding the patent eligible for PGR and each challenged claim more likely than not unpatentable under at least one obviousness ground.

  RulingsInstitution decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level). However, we find some ambiguity in the last sentence of Petitioner’s proposal (“A POSITA could substitute additional education for industry experience and vice versa.”) because the reference to “additional education” is not tethered to relevant education. Accordingly, we modify the last sentence of Petitioner’s proposal to clarify that the additional education must be relevant. Thus, we restate that for purposes of this Decision, a person of ordinary skill in the art of the ’441 patent would have had: (i) an associate’s or bachelor’s degree in mechanical, industrial or manufacturing engineering and (ii) at least two to three years of practical experience with designing or manufacturing mechanical products such as food or beverage packaging. A POSITA could substitute additional relevant education for practical experience and vice versa. B. Post-Grant Review Eligibility As a threshold matter, we must determine whether Petitioner has” slip op. at 11

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner

    “In view of the evidence discussed above, we agree with Patent Owner that there is adequate written description support for a transparent container body such that a depression in the container base is “visible through at least a portion of the container body,” as recited in claims 9, 10, 15, and 16. Prelim. Resp. 9. Regarding Petitioner’s assertion that the ’441 patent does not disclose “a transparent/translucent liquid” (Pet. 7), we again disagree. As Patent Owner points out, “the ’441 Patent mentions beverages, such as ‘beer and soda,’ as liquids for which the claimed container would be suitable.” Prelim. Resp. 10 (quoting Ex. 1001, 1:25–27). Patent Owner demonstrates that a person of ordinary skill in the art “would have recognized that beer is typically see-through, or translucent.” Id. (citing Ex. 2012 (Till) ¶ 24 (discussing an inspection apparatus for bottles that “are filled with a transparent liquid (e.g. beer, table water, mineral water, wine etc.)”); Ex. 2013 (Schnuckle) ¶ 8 (noting “translucent to transparent liquids such as water, soda, juice, or the like”)). We agree with Patent Owner that the ’441 patent’s identification of “beer and soda as beverages the described and claimed container was intended to hold” provides adequate written description support “for having transparent or translucent liquids within the container.”12 Prelim. Resp. 10. For the reasons discussed above, on this record Petitioner has not demonstrated that claims 9, 10, 15, and 16 include subject matter having a November 10, 2023, priority date. Thus, Petitioner has not demonstrated that the ’441 patent is eligible for post-grant review under AIA § 3(n)(1)(A).” slip op. at 15

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “Patent Owner’s arguments are unavailing. As an initial matter, Mr. Kirkpatrick is opining about a design patent application, and Patent Owner has not established that Mr. Kirkpatrick possesses the education and experience of a designer of ordinary skill in the art of ornamental aspects of containers for storing liquids or solids. See Ex. 2001 ¶ 5 (implying that Mr. Kirkpatrick is a generalist whose experience with design patents is in preparing formal drawings of designs invented by others).17 For this reason alone, on this record we accord Mr. Kirkpatrick’s declaration little weight on the question of whether the ’195 parent application provides adequate written description support for originally-filed Figure 2 of the ’813 design application. See, e.g., Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case . . . a witness must at least have ordinary skill in the art. Without that skill, the witness’ opinions are neither relevant nor reliable.”). Even if Mr. Kirkpatrick’s opinions were relevant, they would not change our conclusion regarding lack of adequate written description. Mr. Kirkpatrick attributes the differences between the drawings to “choices in drafting strategy of the respective illustrators,” such as how to use “contour lines to illustrate sloped surfaces” and how much detail to include for well-known features like pop-tops. See Ex. 2001 (Kirkpatrick Decl.) ¶¶ 19, 23–24, 28–32.18 These arguments are unavailing. First, there is no evidence of record indicating that the figures in the ’195 parent application and ’813 design application were created by different illustrators. Second, 17 Patent Owner also has not established that Mr. Kirkpatrick possesses the education and experience of a person of ordinary skill in the art of the ’441 patent, as we have defined it here. Supra Section II.A. 18 Mr. Kirkpatrick’s analysis of a photograph of a can submitted by the applicant during prosecution (see Ex. 2001 (Kirkpatrick Decl.) ¶¶ 25–32) is additionally unavailing because there is no evidence of record indicating that the patent illustrator(s) used this particular photograph or the depicted can to create the patent illustrations. we agree with Petitioner that even if different illustrators employ different drafting strategies, this “does not absolve Patent Owner’s responsibility not to add new matter.” Prelim. Reply 6.” slip op. at 28

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

    “Because the ’441 patent is eligible for post-grant review, we turn to an analysis of whether the Petition demonstrates “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). C. Petitioner’s Grounds of Alleged Unpatentability As noted above in Section I.E, Petitioner asserts four different obviousness grounds. At this stage of the proceeding, Patent Owner does not address the merits of Petitioner’s obviousness grounds. See generally Prelim. Resp. For the reasons discussed below, we determine that Petitioner has demonstrated that it is more likely than not that the challenged claims are unpatentable based on the asserted grounds.” slip op. at 34

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham
  Patents in suitUS 11,932,441
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.Instituted
  PTAB · Dec 12, 2024 · PGR2024-00039 · APJ Elizabeth M Roesel · PGR · Institution

  The Board instituted PGR on claims 1–17, finding the Schröder obviousness challenge to claim 1 met the institution threshold; it did not reach the remaining challenges.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “2. Discussion Part I of the Advanced Bionics framework asks whether the same or substantially the same art was previously presented to the Office or whether the same or substantially the same arguments were previously presented to the Office. Advanced Bionics, Paper 6 at 8.” slip op. at 13

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

    “After considering the parties’ arguments and evidence, we determine that Petitioner’s showing for the printed circuit board of claim element 1[c], as summarized above, is sufficient for purposes of granting institution of a post-grant review. For purposes of institution, Petitioner’s contentions are adequately supported by Schröder, which describes inlay 12 as a “flexible carrier material, e.g. PET, Kapton, etc.” and a “carrier” for the antenna, chip module, and “at least one further electronic component,” as well as Schröder’s Figures 7 and 8, which depict inlay 12 between ring halves 16 and 18. Ex. 1007, 12:28–42, 12:48–52, 12:61–65, 13:23–25. We have considered Patent Owner’s argument that Schröder’s inlay 12 “is merely a substance for holding the coil in place, not a printed circuit board,” as well as Patent Owner’s argument contrasting Schröder’s description of inlay 12 with the express disclosure of “a circuit on a circuit board” elsewhere in the reference. Prelim. Resp. 29–30 (emphasis omitted; citing Ex. 1007, 8:57–59, 22:48–50; Ex. 20119). These arguments raise a serious issue about whether a POSITA would have understood Schröder’s inlay 12 as teaching a printed circuit board. This issue would benefit from further development at trial.” slip op. at 23

  • Skill levelSkill level petitioner adoptedOther

    “E. Level of Ordinary Skill in the Art At this stage of the proceeding, there is no dispute about the level of ordinary skill in the art. Based on the testimony of Petitioner’s declarant, we determine that a person of ordinary skill in the art (“POSITA”) would have had a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, and two years of experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. A POSITA would have been familiar with sensor system design and signal processing. A higher level of education or skill can substitute for less experience, and vice versa. Ex. 1002 ¶ 29. We find that the level of ordinary skill in the art, as articulated above, is consistent with the level of technical understanding and competence reflected in the ’702 Patent Specification and the asserted prior art references.” slip op. at 16

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

    “as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.200(b). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012). “The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We agree with the parties that it is not necessary for us to provide an express construction for any claim term for purposes of determining whether to institute a post-grant review. Pet. 7; Prelim. Resp. 21.” slip op. at 17

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,874,702
• Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentable
  PTAB · Nov 27, 2024 · PGR2022-00025 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1–19 are unpatentable because the ’201 patent lacks written description support for the claimed genus of CRF1 receptor antagonists under § 112(a).

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “[A] sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1350 (citing Regents, 119 F.3d at 1568–69). Moreover, “an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.” Id. (citing Regents, 119 F.3d at 1568 (quoting Fiers, 984 F.2d at 1171)). Furthermore, “functional claim language can meet the written description requirement when the art has established a correlation between structure and function.” Id. (citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001))). “[M]erely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id.” slip op. at 42

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the relevant art (“POSA”) “would have a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders . . . [and] would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders.” Pet. 26–27 (citing Ex. 1005 ¶ 34 (Dr. Carey Declaration)). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’201 patent itself, see, e.g., Exs. 1024, 1025, 2003, 2004, 2005, we apply Petitioner’s proposed level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art). C.” slip op. at 22

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve an A4 reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 82. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065. Furthermore, despite Dr. Dobs’ testimony that “[t]he [prior art] references explain the typical CRF1 antagonist consists of a core nitrogen heterocycle with an aryl substituent adjacent to the core nitrogen atom and a branched alkyl group attached at the opposite end of the core,” Dr. Dobs also acknowledged that the “atypical CRF1 receptors depicted in Figures 11 and 12 of Williams had different structures, and lacked the nitrogen heterocyclic core.” Ex. 1042, 127:9–14, 130:13–131:16; see also Ex. 2014 ¶ 83. Additionally, Petitioner’s expert, Dr. Cutler, testified, by way of example, in his Reply Declaration that two of the ‘“first-generation CRF1 antagonists’ identified in Figure 1 of the Williams article do not fall within the Figure 2 structure Dr. Dobs relies upon.” Ex. 1047 ¶ 93. Indeed, with respect to the alleged core pharmacophore that Dr. Dobs” slip op. at 54

  • ExcludeMotion to exclude, deniedMixed

    “with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1042, 52–53, 125–126, 126–128, 128–130) goes to the weight that we assign to such testimony, but we do not find that such testimony, in light of Dr. Dobs’ extensive qualifications as an endocrinologist set forth above, deems Dr. Dobs unqualified to testify concerning the written description issue in this proceeding. For these reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 20 and 75–87 of Exhibit 2014 is denied.” slip op. at 11

  Patent outcomesUS 11,007,201 unpatentable
  § 112 disclosurecites Phillips
  Patents in suitUS 11,007,201
• Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc.Institution denied
  PTAB · Nov 1, 2024 · PGR2024-00025 · APJ Jeffrey W Abraham · PGR · Institution

  The Board denied institution because Petitioner did not show that claims 1–20 were more likely than not unpatentable over either obviousness ground, for lack of utility, or as indefinite.

  RulingsInstitution decision

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

    “Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates 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). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’033 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist along with genetics specialists) and field-side personnel.” Pet. 15 (citing Ex. 1003 ¶¶ 19–22, 44–45). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 15. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 25. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’033 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level”” slip op. at 6

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

    “Petitioner does not offer a specific construction for any claim terms. Pet. 19–20. Rather, Petitioner contends that “the outer boundary of the Challenged Claims lacks reasonable certainty,” and, therefore, “the Challenged Claims are unpatentable as indefinite under §112(b).” Pet. 20. Petitioner further contends that the challenged claims are unpatentable as obvious “regardless of the outer boundary of the claims.” Pet. 21. Patent Owner disagrees with Petitioner’s arguments regarding indefiniteness, and does not construe any claim terms. See generally Prelim. Resp. As explained in detail below, based on the record before us, we are not persuaded by Petitioner’s indefiniteness arguments, and determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable

    “Patent Owner is correct that Petitioner focuses its obviousness challenge on 1PNZQ23’s phenotype, and does not address its genotype. Prelim. Resp. 41–42; see Pet. 26–32 (comparing 1PNZQ23’s phenotype with the phenotypes of the asserted prior art). Petitioner does not direct us to, nor do we discern, any information in the Petition or Reply regarding 1PNZQ23’s genotype that supports Petitioner’s arguments regarding obviousness. Furthermore, Patent Owner offers information suggesting that “the breeding of 1PNZQ23 was unpredictable even with both parents being known in the art.” Prelim. Resp. 47. Dr. Schnable addresses unpredictability in the breeding process, stating: distinct even when the F1 plant itself results from a cross of two inbreds. A [person of ordinary skill in the art] would not expect that a cross of the same parents will produce F2 or D1 progeny identical to 1PNZQ23. . . . [T]he genome of a progeny plant is the result of genetic segregation and recombination in the F1 plant of the two parental genomes and the chance of the exact same child resulting from that initial biparental cross is infinitesimally small. Ex. 2004 ¶ 123. This information undermines Petitioner’s arguments regarding an expectation of success in achieving the claimed invention.” slip op. at 13

  Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
  Patents in suitUS 11,707,033
• Bestway (USA), Inc. v. Intex Marketing, Ltd.Institution denied
  PTAB · Oct 28, 2024 · PGR2024-00036 · APJ Arthur M Peslak · PGR · Institution

  The Board denied institution because claims 1–24 had been statutorily disclaimed, and declined to enter adverse judgment against Patent Owner.

  RulingsInstitution decision

  • Adverse judgmentAdverse judgmentDenied

    “In this case, where Patent Owner disclaims all claims subject to review, we have discretion to decide whether or not to enter adverse judgment. Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 1350 (Fed. Cir. 2018) (“37 C.F.R. § 42.73(b) permits the Board to enter adverse judgment when a patent owner cancels all claims at issue after an IPR petition has been filed, but before an institution decision.”); see Prel. Reply 2 (Petitioner agreeing that, “[w]hen a patent owner disclaims all claims subject to post-grant review, the Board has discretion to enter adverse judgment.”).” slip op. at 6

  None
  Patents in suitUS 11,959,512
• Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Rehearing denied
  PTAB · Oct 1, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Rehearing

  The Board denied rehearing and maintained its denial of PGR because Petitioner did not show that Perkins and RCSB PDB made claims 1–30 more likely than not unpatentable.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. LEGAL STANDARD Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists where a “decision [i]s based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). A rehearing request is not an opportunity for the requesting party to reargue its case or merely to express disagreement with the underlying decision. Nor is it an opportunity for the moving party to present new arguments that were not in its original submissions.” slip op. at 3

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

    “Owner’s argument persuasive because Perkins discloses embodiments with “mutations at I182 among a group of 20 other possible locations for modifications,” 13 of which are mutations of specific amino acids that “can be changed to any of the 19 other natural amino acids.” Id. Perkins discloses further that modifications at each of those 20 possible sites can be combined such that “one, two, or more” of the mutations can be made together in other embodiments (Ex. 1006, 17–18), or in other words, “each species [is] combinable to create a vast number of species.” Dec. 35. In addition to the locations of modifications expressly listed in Perkins, Perkins adds yet another option in which “the mutated VSV-G envelope protein is as described in Nikolic et al.” (Ex. 1006, 18), which “describes the crystal structures of VSV G bound to its native LDL-R receptor” that RCSB PDB depicts in entries 5OY9 and 5OYL (Dec. 18). We also considered Dr. Rose’s testimony about the crystal structures depicted in RCSB PDB, namely that a person of ordinary skill in the art would have been motivated to modify Perkins based on the VSV-G crystal structures in the RCSB PDB. Perkins taught that mutations to VSV-G “inhibit binding of VSV-G to the low-density lipoprotein receptor (‘LDL-R’), while preserving the VSV-G protein’s fusogenic function,” and expressly disclosed making a mutation at I182. (See, e.g., Ex. 1005 at 19:29-20:2, 20:29-21:14, 21:16-27; Ex. 1006 at 16.) The VSV-G crystal structures in the RCSB PDB taught that I182 is nearby negatively charged amino acids on the LDL-R. Thus, a person of ordinary skill in the art would have been motivated to incorporate a mutation which negated an interaction with the negatively charged residues in the LDL-R. (Ex. 1005 at 19:29–20:2; Ex. 1006 at 16.) Dec. 37. discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 6

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

    “discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 7

  § 103 obviousness
  Patents in suitUS 11,767,366
• Nexus Pharmaceuticals, LLC v. Exela Pharma Sciences, LLCInstitution denied
  PTAB · Aug 8, 2024 · PGR2024-00016 · APJ Ulrike W Jenks · PGR · Institution

  The Board denied institution of PGR on claims 1–30 under § 325(d), finding substantially the same art or arguments had been presented to the Office and no material error was shown.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied

    “Under 35 U.S.C. § 324(a), a post-grant review may be instituted only if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we exercise discretion to deny institution under § 325(d). Accordingly, we do not institute a post-grant review of the challenged claims of the ’370 patent.” slip op. at 2

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

    “review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.”3 Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). We consider several non-exclusive factors as set forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (Dec. 15, 2017) (precedential as to § III.C.5, first paragraph) (“Becton, Dickinson”), which “provide useful insight into how to apply the 3 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a). framework” under § 325(d). Advanced Bionics, 9. These non-exclusive factors include: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the 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; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the prior art or arguments. Becton, Dickinson, 17–18 (formatting added). “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office.” Advanced Bionics, 10.” slip op. at 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art: would have had an advanced degree like a Ph.D. or equivalent in chemistry, biochemistry, pharmaceutics, pharmacy, or a related pharmaceutical field, with at least two years of experience in pharmaceutical formulation development, analysis, optimization and manufacturing, including experiences with processes and techniques for minimizing impurities in, and improving the stability of, pharmaceutical drug products during manufacture and storage. Pet. 27 (citing Ex. 1003 ¶ 24). Petitioner also states that one of ordinary skill in the art “may also have lesser levels of education but more years of experience” and “[a] multi-disciplinary team consisting of individuals with different skills and experience could also suffice.” Id. Patent Owner argues that: A person of ordinary skill in the art has attained a Pharm. D., or M.S. or Ph.D. in chemistry, chemical engineering, or a related field; has three or more years of experience in developing aqueous drug formulations; and has access to other scientists to collaborate and consult with on, for example, characterizing the drug formulation, manufacture of the drug formulation, and clinical use and effect of the drug formulation.” slip op. at 7

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

    “Because this Decision declining to institute trial does not necessitate the application of any express claim construction, we need not construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8

  Claim constructionDiscretionary denial
  Patents in suitUS 11,642,370
• Microchip Technology Inc. v. Aptiv Technologies AGInstituted
  PTAB · Jul 15, 2024 · PGR2024-00011 · APJ Jean R Homere · PGR · Institution

  The Board instituted PGR on claims 1–15 and all asserted grounds, finding a reasonable likelihood that at least claim 1 is obvious over Chang, Chang II, and POSITA knowledge.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 324(a) (2018); 37 C.F.R. § 42.4(a) (2023) (“The Board institutes the trial on behalf of the Director.”). Section 324(a) provides that a post-grant review may not 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 considering the evidence and arguments in the Petition (including its supporting testimonial evidence) and the evidence and arguments in the Preliminary Response (including its supporting testimonial evidence), we determine that the information presented shows that it is more likely than not that Petitioner would prevail with respect to at least one of the challenged claims. Accordingly, we institute post-grant review on all” slip op. at 2

  • Other 314aDenied

    “Petitioner hereby stipulates that, if the PTAB institutes this post-grant review, Petitioner will not pursue invalidity of the Challenged Claims in a parallel district court proceeding on the same grounds or any grounds that could have reasonably been raised before the PTAB in this Petition. Pet. 106. Petitioner cites the Director’s Memorandum, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation, issued June 21, 2022 (“Guidance Memo”)3 in support of its contentions. Pet. 106.” slip op. at 11

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “§ 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). In applying the two-part framework, we consider several non-exclusive factors, including: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; (d) the extent of the 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; (e) whether petitioner has pointed out sufficiently how the examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5, first paragraph) (“Becton, Dickinson”). Becton, Dickinson factors (a), (b), and (d) relate to whether the art or arguments presented in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, Paper 6 at 10. Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in its prior consideration of that art or arguments. Id. Only if the same or substantially the same art or arguments were previously presented to the Office do we consider whether the petitioner has demonstrated a material error by the Office. Id. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 14

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “At the time of the invention, a POSITA would have had a bachelor’s degree in computer science, electrical engineering, or an equivalent, and two years of professional experience working with computer network protocols such as USB. Lack of work experience can be remedied by additional education, and vice versa. Id. (citations omitted). At this stage, we find Patent Owner’s proposed level of a POSITA to be consistent with the problems and solutions disclosed in the ’643 patent and prior art of record, and adopt it as our own for purposes of this Decision. See, e.g., In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (approving the determination of the level of ordinary skill in the art by appeal to the references of record). We nonetheless invite the parties to further address this issue, if they deem it necessary and appropriate. The parties should also specifically explain how different definitions for one of ordinary skill in the art relate to specific arguments and issues of unpatentability or claim construction, to the extent that a dispute remains as to who constitutes a POSITA.” slip op. at 20

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · Graham · Nautilus
  Patents in suitUS 11,681,643

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.