• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Oct 15, 2026 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1, 2, and 6–30 are unpatentable under §112(a) for lack of written description and lack of enablement; the §103 ground was not reached.

  RulingsFinal written decision

  • Additional discoveryAdditional discovery, deniedDenied

    “Patent Owner filed a Motion for Additional Discovery (Paper 42), Petitioner opposed the motion (Paper 44), and the Board denied the motion (Paper 47).” slip op. at 3

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

    “of the ’758 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’758 patent. Indeed, both the definitions of “PH20” and “modified PH20 polypeptide” require hyaluronidase activity. See Ex. 1001, 45:54–55, 50:39–41 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 48:43–46 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 63:39–46. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’758 patent. Id. at 72:63–65, 75:60–62. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–46.” slip op. at 21

  • Skill levelOther

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–251 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’758 patent.” slip op. at 56

  Patent outcomesUS 12,054,758 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,054,758
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Oct 15, 2026 · PGR2025-00024 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1, 2, 6–15, and 17–30 are unpatentable under §112(a) for lack of written description and enablement; the §103 ground was not reached.

  RulingsFinal written decision

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

    “this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–250 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’590 patent.” slip op. at 56

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

    “6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 75

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “4. Analysis Based on the evidence of record, we agree with Patent Owner that Petitioner has not provided any persuasive reason to particularly target the leucine at position 307 of a PH20 polypeptide for modification as recited in claim 1 of the ’590 patent. It is undisputed that neither of the cited prior art references, the ’429 patent or Chao, specifically identifies or discusses position 307 of the PH20 polypeptide. See, e.g., Pet. 88‒109; PO Resp. 86‒ 93. We are not persuaded by Petitioner’s argument that multiple sequence alignments identify amino acids that are tolerated at particular positions (see Pet. 99‒109), because tolerance is not a positive reason to make a substitution. “It is not enough, even after KSR, to support a determination of obviousness that a reference includes a broad generic disclosure and a common utility to that in the claims and other prior art references—there must be some reason to select a species from the genus.” Knauf Insulation, Inc. v. Rockwool Int’l A/S, 788 F. App’x 728, 733 (Fed. Cir. 2019). Dr. Park identified 379 positions in PH20 (i.e., ~85% of the protein) with evolutionary variation, that is, where “homologous proteins have tolerated different amino acids at those positions.” Ex. 1004 ¶ 31. Dr. Park distributes the twenty standard amino acids into four categories depending on their roles in forming secondary structure such as alpha helices or beta sheets, with each category having a minimum of six members. See id. ¶ 70. Nothing in the prior art or Dr. Park’s analysis directs the ordinary artisan to position 307 itself. Although Dr. Hecht asserts that the ’429 patent suggests conservative mutations generally, Petitioner did not point us to any specific teaching or” slip op. at 126

  • Additional discoveryAdditional discovery, deniedDenied

    “Patent Owner filed a Motion for Additional Discovery (Paper 41), Petitioner opposed the motion (Paper 43), and the Board denied the motion (Paper 46).” slip op. at 3

  Patent outcomesUS 12,060,590 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,060,590
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

  Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9

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

    “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

  • BurdenNot shown unpatentable

    “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

    “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

  Patent outcomesUS 11,959,109 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,959,109
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision

  Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13

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

    “C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21

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

    “Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38

  Patent outcomesUS 11,236,318 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,236,318
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Jun 24, 2026 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1, 2, 6–14, and 16–29 are unpatentable based on written description, enablement, and obviousness grounds.

  RulingsFinal written decision

  • Director reviewDirector review, deniedDenied

    “Following institution, Patent Owner filed a Director Review Request (Paper 33), and Petitioner filed an Authorized Response (Paper 37), and the then-Acting Director issued a denial of the Director Review Request. Paper 40.” slip op. at 3

  • Additional discoveryAdditional discovery, deniedDenied

    “(Paper 46, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response (Paper 71, “Pet. Reply”), and Patent Owner filed a Sur-reply (Paper 84, “PO Sur-reply”). Patent Owner filed a motion for additional discovery (Paper 62), Petitioner opposed the Motion for Discovery (Paper 63), and the Board denied the Motion for Discovery (Paper 77).” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

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

    “description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’035 patent.” slip op. at 53

  Patent outcomesUS 12,123,035 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,123,035
• Tesla, Inc. v. Intellectual Ventures II LLCNo claims unpatentable
  PTAB · Jun 23, 2026 · IPR2025-00219 · APJ Frederick C Laney · IPR · Final written decision

  Claims 11–22 were not shown unpatentable under any § 103 ground because the prior art did not teach or suggest receiving the claimed resource allocation and multi-level TPC command on one physical channel.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). Moreover, a petitioner should 1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat. 284 (2011), amended 35 U.S.C. § 103, effective March 16, 2013. Because the application from which the ’153 patent issued claims priority to an application filed before this date, the pre-AIA version of § 103 applies. not “place the burden on [the Board] to sift through information presented by the Petitioners, determine where each element [of the challenged claims] is found in [the cited references], and identify any differences between the claimed subject matter and the teachings of [the cited references.]” Google Inc. v. EveryMD.com LLC, IPR2014-00347, Paper 9 at 25 (PTAB May 22, 2014).” slip op. at 5

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “The second and third asserted benefits—reduced complexity and reduced latency—rest on the declaration of Dr. Kotzin (Ex. 1003 ¶ 64) rather than on any disclosure of Andersson or Khan. We accord that testimony little weight on this point because it asserts the benefits in conclusory terms without explaining why they would result from inserting a scheduling grant into Andersson’s undefined “other bits,” as distinct from Khan’s separate-slot design.” slip op. at 20

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A. Level of Ordinary Skill in the Art Petitioner asserts that ordinarily skilled artisans “would have a bachelor’s degree in electrical engineering, computer engineering, computer science, or equivalent training, and approximately two years of experience working in the field of wireless communication systems or design of similar communication systems.” Pet. 14. Petitioner’s proposed definition, which Patent Owner does not dispute, appears reasonable and consistent with the asserted prior art and the ’500 Patent. Therefore, we adopt it as the ordinary level of skill of an artisan in the field of the patented technology for our analysis below.” slip op. at 7

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

    “Patent Owner offers a proposed construction for the recited “single physical channel” found in limitation 11.2 and “an accumulation of TPC commands” found in independent claims 12 and 18. PO Resp. 9–17. Petitioner likewise addresses the scope of an accumulation of TPC commands, but Petitioner does not contest directly Patent Owner’s proposed construction for “single physical channel.” Pet. Reply 2–7. We determine, however, that no express construction of any claim term is necessary to resolve the dispute between the parties. 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

  Patent outcomesUS 9,706,500 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,706,500
• Avanos Medical, Inc. v. Stratus Medical, LLCAll claims unpatentable
  PTAB · Mar 5, 2026 · IPR2024-01212 · APJ Arthur M Peslak · IPR · Final written decision

  Claims 1–29 are unpatentable because Petitioner showed by a preponderance of the evidence that the asserted prior-art combinations rendered them obvious under §103.

  RulingsFinal written decision

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

    “improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. In this case, we must determine whether one of ordinary skill in the art would recognize that applying the teachings of Fitz and Lee of deploying multiple filaments to increase and control the ablation volume to Racz’s distal tip would improve Racz’s device in the same way. For us to resolve this question in Petitioner’s favor, Petitioner must provide “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Id. at 418 (citing In re Kahn, 441 F.3d at 988). However, bodily incorporation, i.e., “an actual physical substitution of” Lee’s filaments into Racz is not required. See In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.”); In re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”).” slip op. at 30

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “11. Balancing the Graham Factors After weighing all the evidence submitted by the parties in light of the Graham factors, we determine Petitioner has demonstrated by a preponderance of the evidence that the claims 1, 3–10, 18–26, 28, and 29 would have been obvious over Racz, Fitz, and Lee. As discussed above, Petitioner’s evidence establishes that the combination of Racz, Fitz, and Lee teaches every limitation of claims 1, 3–10, 18–26, 28, and 29 and that an ordinarily skilled artisan would have been motivated to combine Racz, Fitz, and Lee with a reasonable expectation of success. Further, as discussed above, Patent Owner’s evidence of secondary considerations is entitled to little, if any, weight because Patent Owner fails to establish nexus. Consequently, after considering all the evidence in the record both for and against patentability, we determine that Petitioner has shown by a preponderance of the evidence that claims 1, 3–10, 18–26, 28, and 29 would have been obvious over Racz, Fitz, and Lee. E. Ground B: Obviousness in view of Racz, Fitz, Lee and Young ’965 Petitioner contends that claims 1–10, 18–26, and 28–29 are also obvious over Racz, Fitz, Lee, and Young ’965. Pet. 62–67. Patent Owner argues that Young ’965 does not cure the alleged deficiencies in Ground 1, is directed to tumor ablation not neurotomy, would require a substantial redesign of Racz’s modified device, and there is no motivation to combine. PO Resp. 59–60. We start with a brief overview of Young ’965 and address the parties’” slip op. at 78

  • ExcludeMotion to exclude, deniedDenied

    “Accordingly, both Motions are dismissed as moot.” slip op. at 94

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the type of” slip op. at 12

  Patent outcomesUS 10,925,664 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,925,664
• Alamar Biosciences, Inc. v. Olink Proteomics ABNo claims unpatentable
  PTAB · Mar 4, 2026 · IPR2024-01353 · APJ Tawen Chang · IPR · Final written decision

  Claims 1–20 were not shown unpatentable: the asserted obviousness grounds failed, including because Kanan and Neri did not teach selecting the claimed cis-reactive cells.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Accordingly, for purposes of this decision we adopt Petitioner’s proposal of a person of ordinary skill in the art, with the following changes noted in italics below: A person with “an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to small molecules and proteins and would have been familiar with nucleic acid chemistry and conventional hybridization techniques; and (b) access to one or more team members having an advanced degree, such as a Ph.D., in organic chemistry, molecular biology, biochemistry, or a related field; and about two years of experience in industry and/or laboratory experience relating to high throughput screening techniques such as nucleic acid sequencing. A person could also have qualified as a POSA with less formal education and more technical or professional experience.11 We emphasize, however, that our decision would not change if we instead used Patent Owner’s proposed definition of a POSA.” slip op. at 13

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

    “Because the parties have placed the limitation “selecting all cis- reactive cells exhibiting the detectable trace” into controversy, we construe the term below, but only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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)). For the reasons discussed below, we agree with Patent Owner that the plain and ordinary meaning of this phrase, in light of the language of the claims, the Specification, and the prosecution history of record, requires “selecting all of the [molecular complexes or structures] meeting the defined criteria for [cis-reactive cells (CRCs)] and exhibiting the detectable trace.” Sur-reply 8 (citing Ex. 2008 ¶¶ 94, 98–119). We further agree that cis-reactive cells should be construed to mean “an association of at least two interactor moieties, joined by an associated oligonucleotide.” (PO Resp. 9 (quoting Ex. 1001, 9:35-37)). Accordingly, we determine that, properly construed, the claims require that what is “selected” at step 1(d) — what is differentiated or set apart from other molecular complexes or structures in the reaction mixture at the conclusion of step 1(d) — to be “an association of at least two interactor moieties joined by an associated oligonucleotide” that exhibits the detectable trace.” slip op. at 16

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

    “We agree that Petitioner has not shown that the combination of Kanan and Neri teaches “selecting all cis-reactive cells exhibiting the detectable trace,” as we have construed that phrase above. In particular, we determine that, properly construed, the limitation requires the selection of “all associations of at least two interactor moieties joined by an associated oligonucleotide and exhibiting the detectable trace.” Instead, as described in Kanan, what is “selected” is the molecules of interest joined by bond formation, with only one of the molecules of interest coupled to a nucleic acid moiety. Thus, the selected molecular complex or structure does not comprise two interactors (i.e., two molecules of interest coupled to NAMs). Moreover, to the extent there are two interactors, they are joined by the bond between the molecules of interest rather than an associated oligonucleotide.” slip op. at 35

  • ExcludeMotion to exclude, deniedDenied

    “III. PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE Patent Owner moved to exclude Exhibit 1008, on the ground that it contains settlement statements and that Rule 408 of the Federal Rule of Evidence prohibits Petitioner from using the statements to impeach or contradict Patent Owner. Mot. 5. Because we do not rely in our analysis on this exhibit, we dismiss the Motion to Exclude as moot.” slip op. at 43

  Patent outcomesUS 7,883,848 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,883,848
• Apple Inc. v. Theta IP, LLCSome claims unpatentable
  PTAB · Nov 25, 2025 · IPR2024-00819 · APJ Russell E Cass · IPR · Final written decision

  Claims 1–19 are unpatentable as obvious over Behbahani, Leete, and Tan; claim 20 was not shown unpatentable because the references did not teach its required comparison of desired and interferer signal strengths.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Petitioner thus proposes a Master’s degree with two years of experience, while Patent Owner proposes a Bachelor’s degree with five years of experience. At the institution stage, we did not see a material difference in the proposals given that both parties also indicate that more education could substitute for less experience and vice versa, and thus adopted Patent Owner’s proposal. Inst. Dec. 9. We requested that the parties address during trial if either believed that the choice of one proposal over the other would make a difference in the patentability analysis. Id. Neither party has done so. Accordingly, because nothing in the record persuades us that our preliminary finding in the Institution Decision was incorrect, and because neither party has challenged our finding, we maintain our adoption of Patent Owner’s proposed level of ordinary skill in the art.” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “Here, as in the Director’s example, Petitioner advanced a narrower construction of the dynamic limitations before the district court, which the district court declined to adopt. Pet. 9; Ex. 2015; Ex. 2025, 31–47. Instead, the district court adopted a “plain-and-ordinary meaning” construction, which Patent Owner proposed. PO Resp. 38; PO Sur-reply 10 n.2; Ex. 2015; Ex. 2025, 31–47. In the Petition, Petitioner proposed applying the plain and ordinary meaning construction that had already been preliminarily adopted by the district court. Compare Pet. (filed May 1, 2024) with Ex. 2015 (preliminarily adopting plain and ordinary meaning construction on March 25, 2024). Applying Revvo, we find that Petitioner had a sufficient reason for advancing the broader, court-adopted construction in this IPR. Thus, we give the dynamic limitation its plain-and-ordinary meaning, which is “adjusting during operation based—at least in part—on information gained during operation.”” slip op. at 13

  • Prior constructionPrior construction adoptedDecided for patent owner

    “In our Institution Decision, we stated that we “will give the term ‘signal path’ its ‘plain and ordinary meaning’ and not limit it only to analog components, as the district court found and the parties agree.” Inst. Dec. 11. Given that the parties continue to agree on this point, we see no need to depart from the construction we adopted in our Institution Decision. Moreover, applying Revvo, we find that Petitioner had a sufficient reason for advancing the broader, court-adopted construction in this IPR for the same reasons as discussed above. In this proceeding, the dispute between the parties concerns the application of this and the surrounding claim language (i.e., “in the receiver signal path,” “in the signal path”) to the disclosures in Behbahani. See PO Resp. 43–45. Therefore, we will provide further discussion in the context of the parties’ arguments regarding Behbahani below. However, we agree with Patent Owner’s plain reading of the claim language to the extent it requires adjusting an impedance and/or bias current of a circuit while it is in the signal path. See Id. at 50–51.” slip op. at 14

  • Expert testimonyPatent owner expert discountedOther

    “Patent Owner’s arguments generally fail to address why Behbahani’s Variable Bandpass Filter Block does not teach the recited “plurality of circuits [comprising/including] . . . a filter,” and instead focus on why the low-pass and high-pass filter circuits do not teach the limitation, which is not Petitioner’s position. As stated above, we agree with Patent Owner’s plain reading of the claim language – i.e., that it “requires adjusting the bias, in or of a circuit.” See PO Resp. 49. However, Patent Owner’s reading of the claim does not persuasively address why the Variable Bandpass Filter Block does not teach the recited “circuit.” We have reviewed Dr. Larson’s cited testimony and disagree with Patent Owner that he provided “a well-supported opinion . . . as to why a [person of ordinary skill in the art] would not understand the entire bandpass box to be a single ‘circuit,’ or to reflect variation in ‘an impedance’ or ‘a bias’ in the claims.” Sur-reply 4 (citing Ex. 2020 ¶¶ 46–48, 71, 74–83). Dr. Larson testifies that the ’330 patent (which has the same specification as the ’164 patent) “teach[es] these adjustments [that dynamically change operating parameters] as changes effected in a single circuit block.” Ex. 2020 ¶ 46 (citing, e.g., Ex. 1001, Figs. 8A, 9A, 8:20–25, 8:36–39, 9:36–59, 10:1–18 (emphasis added)). Dr. Larson does not provide further explanation as to what he means by a “single circuit block,” but relies on Figures 8A and 9A, which show a “function block,” and other disclosures referring to a “function block.” See id. There is no dispute that the recited “circuit” in the receiver signal path is referring to these “function blocks.” See Tr. 22:20–23:4. The ’164 patent states that Figure 8A, which includes function block 820, is “an embodiment of the present invention” 8:28–30. Similarly, Figure 9A, which includes function block 920, “illustrate[s] one of the possible power saving techniques.” Id. at 3:41–42. The ’164 patent describes that “[f]unctional block 820 . . . may be a filter, mixer, amplifier, or other circuit or circuits in a wireless transceiver or other electronic circuits or system.” Id. at 8:30–33 (emphasis added). Based on these disclosures, we are not convinced that Function Block 820 or 920 cannot include multiple filters in a Variable Bandpass Filter Block, or that Behbahani’s Variable Bandpass Filter Block does not teach the recited “circuit.” Dr. Larson also relies on Figure 6 of the ’164 patent to conclude that” slip op. at 45

  Patent outcomesUS 11,564,164 mixed
  Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 11,564,164
• Apple Inc. v. Theta IP, LLCAll claims unpatentable
  PTAB · Nov 24, 2025 · IPR2024-00816 · APJ Russell E Cass · IPR · Final written decision

  Claims 1–7, 9–13, 16, 23, 25–27, and 29 are unpatentable as obvious over Behbahani, Leete, and Tan.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Petitioner thus proposes a Master’s degree with two years of experience, while Patent Owner proposes a Bachelor’s degree with five years of experience. At the institution stage, we did not see a material difference in the proposals given that both parties also indicate that more education could substitute for less experience and vice versa, and thus adopted Patent Owner’s proposal. Inst. Dec. 11. We requested that the parties address during trial if either believed that the choice of one proposal over the other would make a difference in the patentability analysis. Id. Neither party has done so. Accordingly, because nothing in the record persuades us that our preliminary finding in the Institution Decision was incorrect, and because neither party has challenged our finding, we maintain our adoption of Patent Owner’s proposed level of ordinary skill in the art.” slip op. at 10

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

    “Here, as in the Director’s example, Petitioner advanced a narrower construction of the dynamic limitations before the district court, which the district court declined to adopt. Pet. 10; Ex. 2015; Ex. 2025, 31–47. Instead, the district court adopted a “plain-and-ordinary meaning” construction, which Patent Owner proposed. PO Resp. 36–38; PO Sur-reply 10 n.2; Ex. 2015; Ex. 2025, 31–47. In the Petition, Petitioner proposed applying the plain and ordinary meaning construction that had already been preliminarily adopted by the district court. Compare Pet. (filed May 1, 2024) with Ex. 2015 (preliminarily adopting plain and ordinary meaning construction on March 25, 2024). Applying Revvo, we find that Petitioner had a sufficient reason for advancing the broader, court-adopted construction in this IPR. Thus, we give the dynamic limitation its plain-and-ordinary meaning, which is “adjusting during operation based—at least in part—on information gained during operation.”” slip op. at 14

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “Variable Bandpass Filter Block does not teach the recited “component” or “impedance” that is dynamically adjusted, and instead focus on why the low-pass and high-pass filter circuits do not teach the limitation, which is not Petitioner’s position. As stated above, we agree with Patent Owner’s plain reading of the claim language – i.e., that it “requires adjusting a variable impedance of a circuit or component thereof, while it is in the signal path.” See PO Resp. 49. However, Patent Owner’s reading of the claim does not persuasively address why the Variable Bandpass Filter Block does not teach the recited “circuit” or “component.” We have reviewed Dr. Larson’s cited testimony and disagree with Patent Owner that he provided “a well-supported opinion . . . as to why a [person of ordinary skill in the art] would not understand the entire bandpass box to be “a component,” “a circuit,” or “an impedance” in the claims.” Sur-reply 4 (citing Ex. 2020 ¶¶ 46–48, 71, 74–83). Dr. Larson testifies that the ’330 patent “teach[es] these adjustments [that dynamically change operating parameters] as changes effected in a single circuit block.” Ex. 2020 ¶ 46 (citing, e.g., Ex. 1001, Figs. 8A, 9A, 8:20–25, 8:36–39, 9:36–59, 10:1–18 (emphasis added)). Dr. Larson does not provide further explanation as to what he means by a “single circuit block,” but relies on Figures 8A and 9A, which show a “function block,” and other disclosures referring to a “function block.” Id. There is no dispute that the recited “circuit” or “component” in the receiver signal path is referring to these “function blocks.” See Tr. 22:20–23:4. The ’330 patent states that Figure 8A, which includes function block 820, is “an embodiment of the present invention” that describes a “possible power saving technique[].” Ex. 1001, 3:30–33, 8:20–25. Similarly, Figure 9A, which includes function block 920, “illustrate[s] one of the possible power saving techniques.” Id. at 3:33–34. The ’330 patent describes that “[f]unctional block 820 . . . may be a filter, mixer, amplifier, or other circuit or circuits in a wireless transceiver or other electronic circuits or system.” Ex. 1001, 8:22–25 (emphasis added). Based on these disclosures, we are not convinced that Function Block 820 or 920 cannot include multiple filters in a Variable Bandpass Filter Block, or that Behbahani’s Variable Bandpass Filter Block does not teach the recited “circuit,” “component,” or “impedance.”” slip op. at 42

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “The absence of meaningful disclosure of the implementation details of the circuit in the ’330 patent suggests that the circuit implementation details Patent Owner argues about now would have been within the understanding of a person of ordinary skill in the art. That is, Patent Owner did not provide in its own specification “the type of detail [it] now argues is necessary in prior art references,” which permits a “finding that one skilled in the art would have known how to implement the features of the references and would have concluded that the reference disclosures would have been enabling.” In re Epstein, 32 F.3d 1559, 1568 (Fed. Cir. 1994). When a patent specification does not “specifically describe[]” any “equipment or techniques to be used,” it may be deduced “that all of the equipment and technical knowledge required to perform the claimed method” is known to one of ordinary skill in the art. In re Fox, 471 F.2d 1405, 1407 (CCPA 1973); see also Southwire Co. v. Cerro Wire LLC, 870 F.3d 1306, 1312 (Fed. Cir. 2017) (without proof to the contrary, when there is no focus on a disputed claim limitation in the specification, the limitation is merely “an observed result of an old process”). To that end, Petitioner provides persuasive testimony from Dr. Abidi that signal strength measurement circuits were known in the art, and that a person of ordinary skill in the art would have understood how to implement a known technique for measuring signal strength, which is not disputed by Patent Owner. Ex. 1003 ¶¶ 180– 181; Ex. 1042 ¶¶ 12–16; see Pet. Reply 24–26; Pet. 60–62. Accordingly, we agree with Petitioner that Behbahani’s disclosure at least suggests circuitry for performing such a determination of signal strength. See Pet. Reply 24 (citing Pet. 60–61; Ex. 1003 ¶¶ 92–98, 179–181). Petitioner further argues that Tan “provides an example of circuitry used to detect signals at various points in the low-pass filter signal path as a means of implementing a prefilter automatic gain control.” Pet. 60–61 (citing Ex. 1006, 481); Ex. 1003 ¶ 180. The example in Tan is a peak detector circuit. Pet. 61; Ex. 1003 ¶ 180; Ex. 1006, Fig. 8. Dr. Abidi testifies that a person of ordinary skill in the art would have been motivated to use Tan’s signal strength measurement circuitry to measure nodes AI and AO. Ex. 1003 ¶ 180. In response to Patent Owner’s argument that Petitioner does not sufficiently explain how to use Tan’s peak detector in Behbahani (PO Resp. 70), Dr. Abidi provides testimony explaining how Tan’s peak detector circuit provides a measure of the signal strength, which we find persuasive, and is unrebutted by Patent Owner. Ex. 1042 ¶ 15.” slip op. at 30

  Patent outcomesUS 7,010,330 unpatentable
  Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 7,010,330

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.