• 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 1, 2026 · PGR2025-00052 · APJ Cynthia M Hardman · PGR · Final written decision

  Claims 1–17 are unpatentable for lack of written description, lack of enablement, and indefiniteness; the Board did not find them unpatentable as obvious.

  RulingsFinal written decision

  • 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 7

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

    “Specification of the ’345 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 ’345 patent. Indeed, the definitions of “PH20” and “modified PH20 polypeptide” both require hyaluronidase activity. See Ex. 1001, 44:20–21, 49:4–7 (“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”); 47:8–11 (“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 61:60–67. 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 ’345 patent. Id. at 71:16-18, 74:11–13. 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 47:3–11.” slip op. at 20

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

    “description (see Capon, 418 F.3d at 1357–58), Patent Owner is trying to extend that to include that which is at most obvious from the prior art, as opposed to what is actually described. That is, it may have been obvious to a POSA to align PH20 sequences with other known hyaluronidase enzymes and to use the crystal structure of a different hyaluronidase (Hyal-1) in SWISS-MODEL to generate a three-dimensional structure, but none of that is described in the common disclosure itself. “[A] description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352. While a POSA might be able to embark on their own research program to try to find suitable multiply-modified PH20 polypeptides, the four corners of the written description do not demonstrate possession of such. See id. at 1356‒57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent[s] a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 66

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

    “instances of epistasis are “rare” and an inactive PH20 polypeptide “will stay inactive . . . absent intentional ‘rescue’ mutations.” See Sur-reply 12–14. But the claims encompass far more than combinations of just two substitutions, and even Dr. Petsko concedes there are “billions” of sequences within the recited sequence space that will not properly fold. See Ex. 2070 ¶ 347; see also Ex. 1133 ¶ 237 (“While some [residues critical to protein structure] can be predicted (e.g., highly conserved positions), many others cannot without experimentation.”). Accordingly, we find Petitioner’s position more persuasive than Patent Owner’s competing position and evidence.” slip op. at 108

  Patent outcomesUS 12,264,345 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 12,264,345
• Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Sep 25, 2026 · PGR2025-00039 · APJ Michael A Valek · PGR · Final written decision

  Claims 1–4 and 7–11 are unpatentable because the challenged claims lack written-description support and are not enabled.

  RulingsFinal written decision

  • Adverse judgmentAdverse judgmentOther

    “1 Although the Petition was directed to claims 1–11 of the ’185 patent, Patent Owner filed a statutory disclaimer of claims 5 and 6 prior to institution, leaving just claims 1–4 and 7–11 at issue. See Ex. 2003.” slip op. at 2

  • 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

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “B. Claim Construction In a post-grant review, we interpret a claim “using the same claim” slip op. at 11

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

    “For these reasons, we find that a preponderance of the evidence” slip op. at 59

  Patent outcomesUS 12,104,185 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,104,185
• Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Sep 25, 2026 · PGR2025-00033 · APJ Michael A Valek · PGR · Final written decision

  Claims 1, 2, and 6–29 are unpatentable for lack of written description and enablement; the Board did not find them obvious over the ’429 patent and Chao.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “structural connections and three-dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 126–212, 297–342; Ex. 2068 ¶¶ 123–125, 245, 294–313, 318) 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 ¶¶ 111–230 (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 ’652 patent.” slip op. at 58

  • 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 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Decided for petitioner

    “exclude the use of modified PH20 polypeptides as contraceptives—the only other possible utility described in the ’652 patent—is unavailing. Resp. 39. First, “[t]he fact that a patent asserts that an invention achieves several objectives does not require that each of the claims be construed as limited to structures that are capable of achieving all of the objectives.” Phillips, 415 F.3d at 1327 (citing Liebel–Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 908 (Fed. Cir. 2004)). Second, unlike the definitions of “PH20” and “modified PH20 polypeptide” in the “Definitions” section of the Specification, the passages describing possible contraceptive use do not contain any characteristics suggesting they are definitional in nature. See Alnylam, 138 F.4th at 133 (enumerating “characteristics” such as the fact that the text appears in the “Definitions” section, sets the term off in quotation marks, and uses phrases like “refer to” that indicate that specification language is definitional in nature). Accordingly, the statement that “[a]lso provided are modified PH20 polypeptides that are inactive, and that can be used, for example, as antigens in contraception vaccines” (Ex. 1001, 75:56–58), does not redefine the term, nor otherwise void the definitional language in the Specification stating that a “modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Id. at 48:47–49 (emphasis added).” slip op. at 26

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

    “1352. While a POSA might be able to embark on their own research program to try to find the genus of multiply-modified PH20 polypeptides recited in the challenged claims, the four corners of the written description here do not demonstrate the inventors were in possession of such. See id. at 1356–57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 68

  Patent outcomesUS 12,049,652 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,049,652
• Microsoft Corporation v. Sterling Computers CorporationAll claims unpatentable
  PTAB · Sep 14, 2026 · IPR2025-00270 · APJ Bach V Hoang · IPR · Final written decision

  Claims 1–13, 15, 18, 20, 21, and 27 are unpatentable as obvious over Rohall and Schiavone, with Gomes added for claims 9 and 27.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Our Institution Decision adopted Petitioner’s definition of a person of ordinary skill in the art. Inst. Dec. 9–10. In its Response, Patent Owner adopts Petitioner’s proposed level of ordinary skill. See PO Resp. 16 (“Patent Owner and its expert adopt the Board’s definition for purposes of this Response.”). Having considered the record, we continue to adopt Petitioner’s proposed level of skill, as articulated above. We are satisfied that Petitioner’s proposal comports with the level of skill necessary to understand and implement the teachings of the ’911 Patent. Accord Inst. Dec. 9–10.” slip op. at 9

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

    “We agree with Petitioner and determine that the construction of “relational references” does not require the use of a relational model and, further, includes pointers that point to related messages exchanged among users. The intrinsic evidence leads us to this construction. First, the relevant language of claim 1 recites “a message container containing relational references pointing to a plurality of sent submessages stored externally to the message container in the message database.” Ex. 1001, 15:56–59. A relational model is not recited in that language or anywhere else in the claim. See id. at 15:51–16:14. Therefore, the claim does not expressly require a relational model. Furthermore, the claim language supports Petitioner’s interpretation that “relational references” include pointers that point to related messages because the claim states that the “relational references” perform the task of “pointing to a plurality of sent submessages.” Pet. Reply 7. Accordingly, the language of the claim supports a construction that does not require a relational model and at least suggests relational references include pointers.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “No other claim terms need construction for our decision here and we decline unnecessarily doing so. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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 15

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

    “We agree with Petitioner that the ordinarily skilled artisan would have been motivated to combine Rohall and Schiavone because Schiavone provides reasons to apply its techniques to email systems such as Rohall’s. Schiavone describes a need for “ensuring compliance of e-mail messages with applicable standards and/or laws and/or otherwise determining appropriateness of a message for an intended recipient,” especially because there is “a patchwork of local, federal and international laws.” Ex. 1006 ¶ 6. Schiavone also states that filtering emails, e.g., to remove spam, is beneficial. Id. ¶¶ 1–2. As Schiavone describes problems in email systems, which its rules-based email processing technique addresses, we determine that the ordinarily skilled artisan would have been motivated to combine Rohall and Schiavone. See KSR, 550 U.S. at 401 (a reference which teaches, suggests, or motivates its combination may “identify a reason that would have prompted a person of ordinary skill in the art to combine the elements”).” slip op. at 19

  Patent outcomesUS 8,073,911 unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 8,073,911
• 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
• X Corp. v. Sterling Computers CorporationAll claims unpatentable
  PTAB · Jun 9, 2026 · IPR2025-00299 · APJ Bach V Hoang · IPR · Final written decision

  Claims 1–22 are unpatentable as obvious over the stated Dumais-based and Kircher/Krug grounds; Patent Owner’s and Petitioner’s motions to exclude are dismissed as moot.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Our Institution Decision adopted Petitioner’s definition of a person of ordinary skill in the art. Inst. Dec. 8–9. In its response, Patent Owner adopts Petitioner’s proposed level of ordinary skill. See PO Resp. 14–15 (“Patent Owner and its expert adopt the Board’s definition for purposes of this Response”). Having considered the record, we continue to adopt Petitioner’s proposed level of skill, as articulated above. We are satisfied that Petitioner’s proposal comports with the level of skill necessary to understand and implement the teachings of the ’217 Patent. Accord Inst. Dec. 8–9.” slip op. at 9

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)No construction neededNot reached

    “1. “computer program modules” The parties dispute whether four “computer program modules comprising” (1) “a monitoring module,” (2) “a first relevance measurement module,” (3) “a second relevance measurement module,” and (4) “a relevance analysis module” (collectively, “module limitations”) invoke 35 U.S.C. § 112 ¶ 6 and should be treated as means-plus-function limitations. See Pet. 8–18; PO Resp. 15–18; Pet. Reply 3–5; PO Sur-reply 4–7. However, the parties do not argue that the construction of these terms affects the analysis of Petitioner’s challenges. See PO Resp.; Pet. Reply; PO Sur-reply. Moreover, our analysis does not rely on any particular construction of these terms and, so, we need not resolve this dispute.” slip op. at 10

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

    “2. “one or more measures derived from the group consistent of” Petitioner asserts limitations 1[g] and 1[g][i]–1[g][iv] recite an open Markush group listing alternatively useable members. Pet. 20–21 (citing Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1372 (Fed. Cir. 2005); Abbot Lab’ys v. Baxter Pharm. Prod., Inc., 334 F.3d 1274, 1281 (Fed. Cir. 2003) (explaining that the listing of specified alternatives within a claim is referred to as a Markush group or Markush grouping)); See Ex. 1001, 47:47–58. Patent Owner does not dispute Petitioner’s construction. See PO Resp; PO Sur-reply. As these terms are not in controversy, we need not opine on this construction.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITANo construction neededNot reached

    “Petitioner’s and Patent Owner’s respective constructions overlap in their requirement that “cognate” users share similar past user actions and assessments or are defined by similar direct input by the user. See Pet. 18; PO Resp. 20–21; PO Sur-reply 10. Petitioner argues that Patent Owner’s construction “exclude[s] ‘groups’ from the claims” and further limits the scope of to users who share actions (Pet. Reply 8–9), but Patent Owner states that its proposed construction does not so limit the claims (PO Sur-reply 10). As such, there is no disagreement that “cognate” users share similar past user actions and assessments or are defined by similar direct input by the user. As there is no controversy, we need not, and do not, construe the meaning of “cognate.” However, Patent Owner’s requirement that “at least one other of the plurality of users” is specifically cognate to “the user” who was sent the content is plainly recited in the claim language itself. The claim recites a “relevance score of a piece of electronic content sent from a sender to a user” in the preamble and similarly again in limitation 1[g]. See Ex. 1001, 47:25–28 (emphasis added), 45:62–64. The limitation in question directly references the claimed “user” when reciting the cognate relationship: “identify at least one other of the plurality of users . . . that is cognate to the user.” Ex. 1001, 47:43–45 (emphasis added). As such, the claim language plainly supports Patent Owner’s requirement and Petitioner does not contest that requirement. See Pet. Reply 8. least one other of the plurality of users . . . that is cognate to the user” as requiring that the identified other user is cognate specifically to the user whose relevance score is being determined.” slip op. at 12

  Patent outcomesUS 7,716,217 unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 7,716,217
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Jun 8, 2026 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1–4, 7–19, and 22 are unpatentable under § 112(a) for lack of written description and enablement, and under § 103 as obvious.

  RulingsFinal written decision

  • 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

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “1. Petitioner’s Position Petitioner asserts that the “terms used in the claims are either” slip op. at 12

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

    “7. Analysis We find the preponderance of the evidence supports a finding that the” slip op. at 59

  • 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 70

  Patent outcomesUS 12,018,298 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,018,298
• Assa Abloy AB / Assa Abloy Inc. et al. v. CPC Patent Technologies Pty, LtdNo claims unpatentable
  PTAB · May 27, 2026 · IPR2022-01093 · APJ Scott A Daniels · IPR · Remand

  Claims 13 and 14 were not shown unpatentable because the evidence did not establish that the received card information defines the memory location for the biometric signature.

  RulingsRemand decision

  • RemandOther

    “On appeal, the U.S. Court of Appeals for the Federal Circuit reversed our Original Decision and remanded the case for further proceedings. CPC Pat. Techs. Pty Ltd. v. ASSA Abloy AB, No. 2024-1492, 2025 WL 3134960, at *1 (Fed. Cir. Nov. 10, 2025), Paper 43. The Federal Circuit also noted that in light of the affirmance of our decision in another proceeding, IPR2022- 00600, challenging the same patent, the “errors the Board made in this appeal only extends to claims 3–18, which were not at issue in the other appeal.” Id. at *3 n 1. Therefore, in this proceeding, only challenged claims 13 and 14 remain. At the request of the parties, we permitted additional briefing addressing the issues on remand from the Federal Circuit. Paper 44. Petitioner filed an opening brief (Paper 51 (“Pet. Remand Br.”)), and Patent Owner filed an opening brief (Paper 52 (“PO Remand Br.”)). Both parties also filed responsive briefs. Paper 54 (“Pet. Responsive Br.”); Paper 55 (“PO Responsive Br.”). This is a Final Written Decision on Remand addressing the patentability of the remaining challenged claims 13 and 14. To prevail, Petitioner must prove unpatentability by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision on Remand is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.” slip op. at 3

  • BurdenNot shown unpatentable

    “offers nothing to suggest that its card information ‘tells you’ where to store the fingerprint data.” ASSA ABLOY AB, 2025 WL 3134960 at *3. Reversing our determinations as to Hsu, the Court found that the testimony of Petitioner’s declarant, Mr. Lipoff, “merely confirms the associative link between the card information and the biometric data. Still missing is any non-conclusory testimony that Hsu’s card information determines the memory location of the biometric data.” Id. at 8. Therefore, on remand, a central question is whether Petitioner has shown sufficiently that Tsukamura cures this deficiency. Petitioner has not done so. In the Petition, Petitioner relies on Tsukamura for teaching a specific location for storing fingerprint data. See Pet. 75 (stating that “Tsukamura’s index number specifies the physical memory location in the memory”). Petitioner argues that “[t]hus, Tsukamura discloses defining, dependent upon the “index number N index,” a memory location for storing a biometric signature (e.g., a fingerprint template), i.e., ‘a memory location is specified by the card information.’” Id. at 75–76 (citing Ex. 1006 ¶ 215). In support, Petitioner’s declarant, Mr. Lipoff, testifies that “[i]f the Tsukamura implementation were used for Sanford-Hsu database, each user/account number would specify a different entry (index number) in the database.” Ex. 1006 ¶ 394. Tsukamura’s index number N index does not teach or suggest much more than Hsu’s using “an account number or employee number, to access a stored there during an enrollment procedure.” Compare Ex. 1004, code (57), with Ex. 1005, 4:7–11. That is, both references arguably teach defining, i.e., setting or establishing, a certain location in a database for biometric data. For example, as described above, Tsukamura’s fingerprint template Temp is stored in flash ROM 35 at a defined index number N index in the database. Id. 4:7–11, 50–54. However, neither Petitioner, nor Mr. Lipoff, persuasively explain how or why Tsukamura’s fingerprint template Temp, stored at index number N index, is commensurate with “means for defining, dependent upon the received card information, a memory location in a local memory external to the card” as recited in claim limitation 13[C]. Ex. 1001, 14:3–5 (emphasis added).” slip op. at 22

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

    “Tsukamura’s index number N index does not teach or suggest much more than Hsu’s using “an account number or employee number, to access a stored there during an enrollment procedure.” Compare Ex. 1004, code (57), with Ex. 1005, 4:7–11. That is, both references arguably teach defining, i.e., setting or establishing, a certain location in a database for biometric data. For example, as described above, Tsukamura’s fingerprint template Temp is stored in flash ROM 35 at a defined index number N index in the database. Id. 4:7–11, 50–54. However, neither Petitioner, nor Mr. Lipoff, persuasively explain how or why Tsukamura’s fingerprint template Temp, stored at index number N index, is commensurate with “means for defining, dependent upon the received card information, a memory location in a local memory external to the card” as recited in claim limitation 13[C]. Ex. 1001, 14:3–5 (emphasis added).” slip op. at 22

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Tsukamura’s index number specifies the physical memory location in the memory. Thus, Tsukamura discloses defining, dependent upon the “index number N index,” a memory location for storing a biometric signature (e.g., a fingerprint template), i.e., the memory location is specified by the index number, under the Second Construction. In my opinion, if the Tsukamura implementation were used for Sanford-Hsu database, each user/account number would specify a different entry (index number) in the database. Ex. 1006 ¶ 394. This is consistent with our understanding of Tsukamura, and we can agree that Tsukamura teaches defining—that is, setting or establishing—a location for storing the biometric signature at “index number N index.” See Ex. 1005, 4:7–11. However, considering the Federal Circuit’s decision, we determine such an associative link does not sufficiently explain how one of ordinary skill in the art would have understood Tsukamura’s IC” slip op. at 23

  Patent outcomesUS 8,620,039 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,620,039

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