• Inari Agriculture, Inc. v. Corteva Agriscience LLCNo claims unpatentable
  PTAB · Nov 18, 2025 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Final written decision

  Petitioner did not show claims 1–8 unpatentable because they are entitled to the 2004 priority date, making Barbour unavailable as prior art.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Entitled to earlier dateDecided for patent owner

    “For a claim to a biological material, the enablement requirement of § 112, first paragraph, does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of access (to the microorganism culture by the public upon issuance of a patent on the application) prior to or during the pendency of the application, so that, upon issuance of a U. S. patent on the application, the public will, in fact, receive something in return for the patent grant. Feldman, 517 F.2d at 1355. Patent Owner has persuaded us that such exception not only applies to a deposit, but also extends to a biological material known and readily available. See 52 Fed. Reg. 34080, 34081. In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art.” slip op. at 15

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

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

    “would understand that the term “‘flanked by’ permits overlap between the expression cassette and the DNA sequence it is flanked by.” Pet. 24–26. Patent Owner does not propose any claim construction. PO Resp. 6–7. On this record and for purposes of this Decision, we see no need to expressly construe any claim term.” slip op. at 9

  Patent outcomesUS 8,901,378 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
  Patents in suitUS 8,901,378
• Duration Media LLC v. Rich Media Club LLCNo claims unpatentable
  PTAB · Aug 19, 2024 · IPR2023-00953 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1–10 were not proven unpatentable under either §103 ground because the evidence did not show the claimed viewability determination.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We find Patent Owner’s argument persuasive. Indeed, it is unclear how Petitioner’s proposal accounts for the types of problems encountered in the art or prior art solutions to those problems. See Daiichi Sankyo, 501 F.3d at 1256 (identifying these factors, among others, as “a guide to determining the level of ordinary skill in the art”). Nor does Petitioner, in its Reply, address, let alone rebut, Patent Owner’s arguments that a person of ordinary skill in the art would have had some experience and/or knowledge in internet advertising. See generally Pet. Reply. Patent Owner proposes that a “person of ordinary skill in the art would have a bachelor’s degree in computer science or a similar major involving computer programming (or at least four years of practical computer programming experience) and at least two years of experience (in or out of college) in the field of internet advertising.” PO Resp. 12 (citing Ex. 2045 ¶54). We agree that a person of ordinary skill in the art would have some experience in internet advertising, although we fail to see why one year would not be enough to familiarize sufficiently a computer scientist and/or programmer with the types of problems encountered in the art or prior art solutions to those problems. Based on the competing proposals, arguments, and evidence before us, we adopt and apply the following level of skill in assessing Petitioner’s challenges to the patentability of the claims of the ’329 patent: a person that would have had a bachelor’s degree in computer science, computer engineering, or electrical (or similar) engineering with about three years of experience being in the field of internet advertising.” slip op. at 10

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

    “Petitioner’s resurrected argument is based on a fundamental misunderstanding of § 311(b). Section 311(b) provides: “A petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed cancel the claims of the ’329 patent on the basis of Badros, Harkins, and Krassner. Pet. 11. Petitioner did not base its request, in whole or in part, on the Krassner publication. Id. Krassner clearly is a patent. It issued on August 13, 2019, far too late to be § 102(b) prior art. Even if we assume Krassner is also a “printed publication” withing the meaning of § 311(b), the same date would apply: August 13, 2019. Petitioner has not presented any evidence that the document that is Krassner was published prior to when it issued on August 13, 2019. That another document (the Krassner publication), which published much earlier, may contain the same or similar disclosure is not relevant to when Krassner was patented or published. In sum, Krassner is not prior art under 35 U.S.C. § 102(b). b) Whether Krassner is Prior Art Under 35 U.S.C. § 102(e) Although Krassner is not prior under 35 U.S.C.§ 102(b), we” slip op. at 13

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “Petitioner responds that, contrary to Patent Owner’s argument, “Harkins teaches that its invention can be used in web pages.” Pet. Reply 18 (citing Ex. 1004 ¶30). Although Petitioner’s citation is off by one paragraph, Petitioner’s response about what Harkins teaches is correct. See Ex. 1004 ¶29 (“The present invention may be implemented for provision of virtually any type of advertising (e.g., print, radio, television, Internet, billboard, etc.) via any type of advertising medium (e.g., newspaper, magazine, radio broadcast, Web pages, billboards, etc.) without departing from the scope of the present invention.”). We find that Harkins is from the same field based on its express statement that it is applicable to “virtually any type of advertising” and “any type of advertising medium,” including “Web pages.” Ex. 1004 ¶29. Further, even if this were insufficient to place Harkins in the same field as the ’329 patent, we find that Harkins is reasonably pertinent to the particular problems with which the ’329 patent inventors were involved. In sum, we find that Harkins is analogous art to the ’329 patent.” slip op. at 19

  • Strike new argumentNew argument disregardedGranted

    “Paper 60 (“PO Mot. To Exclude”), 9–10.6 Patent Owner is correct in this regard and, thus, we grant Patent Owner’s Motion to Exclude with respect to the testimony in the second Smedley Declaration and the Madansky Declaration opining that Badros teaches the determination limitation. Paper 60, 9–12. Petitioner, in its Opposition to the Motion to Exclude, argues that Patent Owner’s arguments about the “viewability test” were “surprising.” Paper 62, 8. We are not persuaded by Petitioner’s argument. The “viewability test” is a claim limitation. Petitioner should have anticipated that Patent Owner would argue that limitation. See In re Gardner, 449 F. App’x 914, 916 (Fed. Cir. 2011) (“This court has held that when evaluating claims for obviousness under 35 U.S.C. § 103, all the limitations of the claims must be considered and given weight.” (citing Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530 (Fed. Cir. 1983)); Univ. of Strathclyde v. 6 Patent Owner’s Motion to Exclude seeks to exclude, in part or in whole, Exhibits 1020–1022, 1025–1030, and 1034–1040, which were submitted with Petitioner’s Reply, of which Exhibits 1026 and 1027 are the declaration by Dr. Madansky and the second declaration by Dr. Smedley, respectively. Mot. To Exclude. The Motion to Exclude also seeks to exclude “Exhibits” 1017 and 1018, which are not filed or of record in this case but which are referenced in the Reply. Id. For example, Exhibit 1017 is the Krassner publication, which Petitioner unsuccessfully moved to add to the record as supplemental information. See Paper 21, 3 n.1 (expunging the Krassner publication and stating that it “need not -- and indeed may not -- be re-filed under a new exhibit number”). Apart from the portions of Dr. Smedley’s second declaration and Dr. Madansky’s declaration opining that Badros teaches the “determination” limitation, we dismiss the Motion to Exclude as moot. obviousness determination generally requires a finding that “all claimed limitations are disclosed in the prior art’.” (citing PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1194 (Fed. Cir. 2014)). Petitioner argues that “[v]iewability tests were well known for well over a decade prior to the ’329 patent’s priority date.” Reply 9. If that were the case, then Petitioner should have made its argument in the Petition. Section 312(a) of Title 35 is titled “Requirements of Petition,” and it specifies that a petition must identify, among other things, “the evidence that supports the grounds for the challenge to each claim, including . . . (B) affidavits or declarations of supporting evidence and opinions, if the petitioner relies on expert opinions.” 35 U.S.C. § 312(a)(3); see also 37 C.F.R. § 42.104(b)(4)–(5) (“The petition must specify where each element of the claim is found in the prior art patents or printed publications relied upon; and . . . the supporting evidence relied upon to support the challenge.”). Thus, “Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Board’s Consolidated Trial Practice Guide, 73 (Nov. 21, 2019).7 Dr. Smedley’s testimony in his second declaration, that “Badros discloses Patent Owner’s ‘viewability test’” (Ex. 1027 ¶11), is clearly evidence to make out a prima facie case of unpatentability. The same is true of Dr. Madansky’s testimony that she agrees with Dr. Smedley in this regard. Ex. 1026 ¶4.” slip op. at 25

  Patent outcomesUS 11,443,329 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites Graham
  Patents in suitUS 11,443,329
• Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentable
  PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

  The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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))).” slip op. at 7

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

    “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 5

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner

    “d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32

  Patent outcomesUS 11,110,087 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,110,087
• Guardant Health, Inc. v. University Of WashingtonNo claims unpatentable
  PTAB · Oct 10, 2023 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–30 were not proven unpatentable because Petitioner failed to establish a reason to combine the Travers references with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that a person of ordinary skill in the art by March 20, 2012 would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields. Pet. 11 (citing Ex. 1002 ¶¶ 46–47). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 5 (citing Ex. 2014 ¶¶ 28–30). After reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languagePlain and ordinary meaningDecided for petitioner

    “Patent Owner argues that, in a few instances, the ’127 patent discloses “sequence reads” as corresponding to “multiple and distinct sequencing reactions.” Id. (citing Ex. 1001, 4:12–18, 4:45–49, 9:5–9, 9:11–12). Those disclosures, however, relate to “only one method for making the invention and do[] not automatically lead to finding a clear disavowal of claim scope.” Cont’l Cirs. LLC v. Intel Corp., 915 F.3d 788, 797 (Fed. Cir. 2019). Patent Owner does not point to, and we cannot find, any intrinsic evidence that would limit “sequence reads” as Patent Owner contends. Patent Owner also relies on Travers as extrinsic evidence that supports its argument. PO Resp. 9. Specifically, Patent Owner contends that Travers “refers to the sense and antisense target DNA sequences as subreads, which are distinct from the ‘raw read sequence’ or ‘raw read’ that comprises all of the subreads physically linked together.” Id. (citing Ex. 1021, 2). Patent Owner, however, ignores that Travers ’075 refers to the sequence of a sense or antisense strand as a “sequence read,” and not a subread. See Ex. 1018 ¶ 61. As a result, we find insufficient evidence to support Patent Owner’s proposed construction of “sequence read” as requiring “multiple and distinct sequencing reactions.”7 Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). Based on the complete record, we see no need to expressly address any other claim term.” slip op. at 11

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

    “We are not persuaded by Petitioner’s arguments. First, the prior art references Petitioner relies on relate to sequencing SMRTbell templates; specifically, they teach two polymerase binding sites in the two hairpin adapters per SMRTbell molecule, one on each end of the target molecule. See Ex. 1021, Fig. 1. They do not speak to concatemers with multiple polymerase binding sites interspersed along the molecule. Second, as explained above, a two-round RCR already generates three polymerase binding sites. See Ex. 2014 ¶ 178. Thus, even if we were to agree with Petitioner that the optimal stoichiometric ratio for SMRTbell templates applies to RCR produced concatemers, the polymerase to concatemer template ratio is at least three, i.e., 50% higher than the number Petitioner points to.11 See Reply 16 (citing Ex. 1035, 34). 11 The product of one round of RCR replication has only two polymerase binding sites. But, with only one copy of A and A each, it would not satisfy Third, and most importantly, the prior art does not support Petitioner’s arguments. The SMRT sequencing “approach is based on eavesdropping on a single DNA polymerase molecule working in a continuous, processive manner.” Ex. 2021, 1 (“Within each [ZMW] chamber, a single DNA polymerase molecule is attached to the bottom surface.”). Indeed, in SMRT sequencing, polymerase molecules are randomly distributed among the ZMWs, leading to a Poisson distribution of occupancy. At optimal loading, the distribution is 36.8% empty ZMWs, 36.8% with just one polymerase, and 26.4% with two or more. In this experiment, ~35% of the ZMWs produced traces indicative of single DNA polymerase occupancy, of which 82% produced full-length reads.” slip op. at 33

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “3. Summary In sum, Petitioner has not met its burden to show that an ordinarily skilled artisan would have had a reason to sequence RCR replicated concatemers on PacBio’s sequencing platform with a reasonable expectation of success. Thus, Petitioner has not shown the Travers references render the claims 1–10, 12, and 15–28 obvious.12 F. Other Grounds Claim 11 depends from claim 1. Petitioner asserts that claim 11 would have been obvious over the combination of Travers ’075, Travers 2010, and NEB Expressions. Pet. 58–60. 12 The parties dispute whether there are objective indicia to support a conclusion of nonobviousness. PO Resp. 68–74; Reply 23–27; Sur-reply 27–29. We do not address this issue because we determine Petitioner has not met its burden in showing the reason to combine/modify the Travers references or the reasonable expectation of success.” slip op. at 45

  Patent outcomesUS 10,760,127 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,760,127
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCNo claims unpatentable
  PTAB · Aug 25, 2023 · IPR2022-00556 · APJ John G New · IPR · Final written decision

  Claims 1–4 were not shown unpatentable because the asserted references did not teach or suggest the limitation requiring no outer graft covering between the fibers and outer frame.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “As the plain language of the claim term suggests, an “outer graft covering” must cover some, or all, of the metallic outer frame of the prosthetic heart valve. Consequently, and according to the plain and ordinary meaning, we understand an “outer graft covering” to be a structure, 29 such as a cloth, fabric or other material, that covers all, or part of, the metallic outer frame. Importantly, because an outer graft covering must cover the external surface of the outer frame, and specifically “between the first portion of fibers and the outer frame,” we understand this claim term to mean that the cover must extend over (i.e., “cover”) not only the struts and members of the metallic outer frame, but must also cover the open spaces, or interstices, in the spaces between those struts and members. Consequently, the ordinary and customary meaning of the limitation “free of an outer graft covering between the fibers and the outer frame” is that there can be no such outer graft covering present anywhere between the outwardly extending fibers and the metallic outer frame.” slip op. at 29

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “As an initial matter, there is little disagreement between the parties and their experts that PET can be a graft covering. However, the disputed limitation requires something more. Specifically, it requires that “the outer seal is free of an outer graft covering between the fibers and the outer frame.” We are not persuaded that Petitioner has demonstrated, by a preponderance of the evidence of record, that Levi, Spenser II, or Walther, upon which Petitioner relies, teaches or suggests the incorporated limitation of claim 1 reciting “wherein the valve assembly is free of an outer graft covering between the first portion of fibers and the outer frame.” In our analysis, we must first determine what is meant by the claim term “outer graft covering.”” slip op. at 29

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

    “Furthermore, our understanding of an outer graft covering as a material or structure that covers at least a portion of the outer surface of the prosthetic heart valve, such that both the struts and members of the metallic outer frame, as well as the interstices between those struts and members, is covered by the outer graft covering, reinforces our prior conclusion that the outer skirt of Levi constitutes an outer graft covering that is prohibited by challenged claim 1. We consequently conclude that Petitioner has not met 35 its burden with respect to demonstrating, by a preponderance of the evidence, that Levi teaches or suggests the limitation reciting “wherein the outer seal is free of an outer graft covering between the fibers and the outer frame.”” slip op. at 35

  Patent outcomesUS 10,987,236 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,987,236
• Restem, LLC. v. Jadi Cell, LLCNo claims unpatentable
  PTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52

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

    “21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31

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

    “[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38

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

    “Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64

  Patent outcomesUS 9,803,176 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,803,176
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations, LLCNo claims unpatentable
  PTAB · Mar 24, 2023 · IPR2022-00034 · APJ John G New · IPR · Final written decision

  Petitioner failed to show claim 6 unpatentable because none of the seven asserted grounds established the required absence of an outer graft covering between the fibers and outer frame.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “November 2012 would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “We determine that, as the plain language of the claim term suggests, an “outer graft covering” must circumferentially cover some, or all, of the metallic outer frame of the prosthetic heart valve. See Merriam-Webster, Cover, available at: https://www.merriam-webster.com/dictionary/cover (last visited March 2, 2023) (defining “cover,” relevantly, as “something that is placed over or about another thing”). See Ex. 3004. Consequently, we understand an “outer graft covering” to be a structure, such as a cloth or fabric or other material, that circumferentially covers all or part of, the metallic outer frame. Importantly, because an outer graft covering must cover the external surface of the outer frame, we understand this claim term to mean that the cover must extend over (i.e., “cover”) not only the struts and members of the metallic outer frame, but must also cover the open spaces, or interstices, in the intervals between those struts and members. Consequently, we construe the limitation reciting “free of an outer graft covering between the fibers and the outer frame” to mean that there can be no such outer graft covering present anywhere between the outwardly extending fibers and the metallic outer frame.” slip op. at 40

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

    “Reply to Patent Owner’s Response, or otherwise provide any additional argument or evidence to demonstrate that the outer skirt of Levi does not constitute the outer graft covering prohibited by claim 6. Consequently, our initial determinations stand. Furthermore, our definition of outer graft covering herein as “a material or structure that circumferentially covers at least a portion of the outer surface of the prosthetic heart valve, such that both the struts and members of the metallic outer frame, as well as the 45 interstices between those struts and members, is covered by the outer graft covering” reinforces our prior conclusion that the outer skirt of Levi constitutes an outer graft covering that is prohibited by claim 6. We consequently conclude that Petitioner has not met its burden with respect to demonstrating, by a preponderance of the evidence, that Levi teaches or suggests the limitation reciting “wherein the outer seal is free of an outer graft covering between the fibers and the outer frame.”” slip op. at 45

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Both the descriptions and Figure 22 of Spenser II show a cloth covering the proximal outer surface of the metallic outer frame of the prosthetic heart valve, including the spaces between the struts and members of the frame. Furthermore, the reference discloses that any fibers extending outwardly from the cloth arise from the surface of the cloth, and are not attached directly to the frame, as depicted in Figure 11 of the ’846 Specification. Thus, even were such fibers made of the same material as the cloth, which is not clear from the reference’s disclosure, the cloth would be between the surface-residing fibers and the metallic outer frame. We conclude that a person of ordinary skill in the art would have recognized that the sleeve-like cloth or fabric of Spenser II corresponds to an outer graft covering between its fibers and its outer frame, and such a covering would be between Spencer II’s surface fibers and its metallic outer frame. Such an outer graft cover is expressly prohibited by the language of claim 6, even if it and associated extending fibers are of the same material.” slip op. at 48

  Patent outcomesUS 10,966,846 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,966,846
• Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Cardiovalve Ltd.No claims unpatentable
  PTAB · Dec 6, 2022 · IPR2021-01051 · APJ John G New · IPR · Final written decision

  The Board granted the non-contingent motion to amend, canceling claims 1–10 and replacing them with claims 11–20, which Petitioner failed to prove unpatentable over Goldfarb ’267.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

    “We conclude that Petitioner’s arguments are insufficient to meet its burden of showing, by a preponderance of the evidence, that Goldfarb ’267 anticipates, or renders obvious, the limitation of proposed substitute claim 11 reciting “advancing the end of the first-clip arm and the end of the second-clip arm out of the delivery tube before advancing the support portion out of the delivery tube” merely requires advancing the ends of the clip arms out of the delivery tube “before advancing the support portion out of the delivery tube.” Moreover, Petitioner’s arguments are not persuasive with respect to proposed substitute dependent claims 12–20 due to their dependence from, and incorporation of, the limitations of proposed substitute claim 11. See Supp. Mot. Amend. 1, Reply Supp. Mot. Amend. 1. We therefore conclude that these proposed substitute claims are similarly neither anticipated by, nor obvious over, Goldfarb ’267. III. CONCLUSION We GRANT Patent Owner’s non-contingent Motion to Amend and Supplemental Motion to Amend, canceling original claims 1–10 and replacing them with substitute claims 11–20. Additionally, for the foregoing reasons, and after having analyzed the entirety of the record and assigning appropriate weight to the cited supporting evidence, we determine that Petitioner has failed to establish, by a preponderance of the evidence, that proposed substitute claims 11–20 are unpatentable.” slip op. at 57

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Having weighed the evidence and Petitioner’s argument, we adopt Petitioner’s definition of a person of ordinary skill in the art as: (1) a mechanical or biomedical engineer with at least three years of experience in designing or developing medical devices who would, where necessary or desired, work or consult with others including a physician to develop such a medical device; or (2) an interventional cardiologist or cardiac surgeon with at least three years of experience developing and/or using medical devices in the heart, and who would, where necessary, work or consult with others including an engineer to develop such a medical device. See Pet. 15–16.” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Vesely. Ex. 1003. We have reviewed the credentials of Dr. Vesely and consider him qualified to provide the opinions for which his testimony has 4 Goldfarb et al. (US 7,563,267 B2, July 21, 2009) (“Goldfarb ’267”) (Ex. 1005). 5 Petitioner refers to Goldfarb’s ’267 disclosure of a further alternative at Ex. 1005 col. 27 ll. 57–60 as Embodiment A. See Pet. 19. We understand the asserted Embodiment A to encompass the description that extends to Ex. 1005 col. 28, l. 9. See Pet. 24–48. 6 Goldfarb et al. (US 7,635,329 B2, December 22, 2009) (“Goldfarb ’329”) Ex. 1006. 7 Ex. 1005 cols. 17–23, ll. 66–29, Figs. 9–16; see Pet. 21–22. been submitted. See id. ¶¶ 1–9; see also Ex. 1004 (Dr. Vesely’s curriculum vitae).” slip op. at 10

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

    “is described in Goldfarb ’267 as plainly a single, unitary structure and, as such, each portion argued as separate elements by Petitioner (i.e., male element (yellow), female element (green), coupling member 19 (blue) and flexible arms 19A and 19B (dark blue)) together form a solid, single component. Thus, all of the “elements” described by Petitioner as being “separate” are in fact a single unit that: (1) bears the weight of the fixation device during delivery; (2) absorbs and transfer the axial and rotational forces imposed by the shaft 12; and (3) holds the device in the correct orientation. Petitioner points to no disclosure of Goldfarb ’267 that suggests these elements act independently or separately to perform the functions of the unitary component, nor can we discern any such disclosure. We therefore find that Petitioner’s argument that only the “male element” portion of coupling member 19 constitutes the “support portion” recited in proposed substitute claim 11 is an arbitrary and unduly restrictive interpretation of the reference’s disclosure. This is particularly true given that Petitioner points to no portion of the male element of coupling member 19 performing a supporting function that is not shared by the other elements of coupling member 19. We conclude that the better understanding of the reference is that the entirety of coupling member 19 (including flexible arms 10A and 19B11) constitutes an analogous support portion, as recited by substitute claim 11, because it provides a unitary structure that performs the supporting functions enumerated by Petitioner.” slip op. at 41

  Patent outcomesUS 10,702,385 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 10,702,385
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

  The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further 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)).” slip op. at 11

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

    “C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659
• Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLCNo claims unpatentable
  PTAB · Feb 15, 2022 · IPR2020-01438 · APJ Ulrike W Jenks · IPR · Final written decision

  Claims 4 and 5 were not shown unpatentable because the evidence, including unexpected results, did not establish obviousness over the asserted prior art.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “to the earliest effective filing date of June 6, 2015, the filing date of the ’063 provisional application, Allgenesis PCT thereby does not qualify as prior art against the ’820 patent. See above II.D. Accordingly, Petitioner has not met the burden of establishing that the claims are unpatentable as obvious over Allgenesis PCT. F.” slip op. at 59

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

    “the reasoning to combine the references, and the evidence of secondary considerations in the form of surprising unexpected results, we determine that Petitioner has not shown that claims 4 and 5 of the ’820 patent are unpatentable. III. CONCLUSION For the foregoing reasons, we conclude that Petitioner has not established by a preponderance of the evidence that claims 4 and 5 of the ’820 patent are unpatentable.” slip op. at 78

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

    “equivalent for another. See In re Omeprazole Patent Litig., 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”). “Conclusive proof of efficacy is not necessary to show obviousness. All that is required is a reasonable expectation of success.” Hoffman-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014).” slip op. at 69

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsObjective indicia with nexusObjective indicia outweighedDecided for patent owner

    “Ex. 1001, 11. Table 2 shows three observation days comparing 0.05% sunitinib TID with 0.05% nintedanib. On all three days, 0.05% nintedanib TID shows significant improvements over 0.05% sunitinib TID. For example, on day 12, the 0.05% nintedanib TID group had a negative value (indicating a reduction in neovascular area), while the 0.05% sunitinib TID group had a positive number (indicating a growth in neovascular area) and the difference between the two is also statistically significant with a P value of 0.016. The comparative data of measuring the reduction in neovascularization in an established animal model as shown the ’820 patent provides a sufficient nexus to the claimed method of reducing hyperemia. The data presented in Table 2 (shown above) shows that nintedanib functions unexpectedly better than sunitinib. The ’820 patent further explains that nintedanib inhibits three kinase targets, FGFR4, Lyn and Src, that are not inhibited by sunitinib, pazopanib, or other common kinases inhibitors. Ex. 1001, 12:14–17; see also id. at 11 (Table 1). In addition, “nintedanib’s potencies on FGFRl-3 are substantially higher than that of sunitinib that may also contribute to the superior efficacy of nintedanib in the cornea suture rabbit model.” Id. 12:17–20. Given these surprising and unexpected results that nintedanib has improved efficacy and a better safety profile compared to sunitinib as reported in the ’820 patent specification convinces us that on balance the weight of the evidence supports a finding that claims 4 and 5 have not been shown to be unpatentable.” slip op. at 77

  Patent outcomesUS 10,149,820 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 10,149,820

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.