• 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
• Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthSome claims unpatentable
  PTAB · Aug 4, 2026 · IPR2025-00249 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1 and 4–8 are unpatentable: claims 1 and 4–6 as obvious over Huang2 and Kuo, and claims 7–8 as anticipated by Huang2; claims 2–3 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “(“POSITA”) “would be a Ph.D. student with a minimum of two years of experience in their faculty advisor’s laboratory” and would have an understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 20– 21 (citing Ex. 1003 § II.C7). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:28–29. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”). Importantly, the Specification does not treat the existence of minor peaks as prerequisites for the existence of major peaks. Indeed, the Specification does not discuss “minor peaks” at all. See generally Ex. 1001. Likewise, none of the claims of the ’227 patent, whether challenged or unchallenged, recites “minor peaks” or any additional peaks beyond the disputed “major peaks.” Id. at 23:30–24:42. Nor does the Specification include an example of FFT analysis results in which the average of the peaks therein is calculated and those higher than the average are identified as major peaks.8” slip op. at 9

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

    “Petitioner has the better position. Huang2 teaches crosslinking and provides a reason for doing so (stability). In particular, Huang2 states: “To better mimic skin ECM, electrospun collagen fibers have been fabricated, however, the rapid degradation and poor mechanical properties determine that either crosslinking or combination with other materials is necessary to obtain a stable scaffold.” Ex. 1005, 1791 (emphasis added). It is true that, in describing work actually carried out, Huang2 states that blending with PCL was performed and does not mention crosslinking. See id. at 1792 (“Nanofibrous matrices of PCL and Collagen at a weight ratio of 3:1 were fabricated using electrospinning as previously described.”). However, the prior art – here, Huang2 – is not limited to that which it describes having created. See In re Mills, 470 F.2d 649, 651 (C.C.P.A. 1972) (“a reference is not limited to the disclosure of specific working examples”); see also In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”); In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (“It is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art.”). Huang2 teaches two stabilization methods when using collagen in scaffolds. Huang2 states that one or the other “is necessary to obtain a stable scaffold” (when using collagen), but it does not preclude or teach away from using Patent Owner-cited testimony of Dr. Mikos is not as definitive as Patent Owner suggests; Dr. Mikos’s testimony is that a person of ordinary skill in the art “typically would not have done both.” Ex. 2015 ¶64 (emphasis added). The bottom line is that Huang2 teaches the person of ordinary skill in the art two ways to stabilize scaffolds/matrices comprised of collagen, provides a reason for doing so (stability), and does not teach away from using both. We are persuaded that a “scaffold comprising crosslinked fibers comprising collagen” would have been obvious in view of the cited teachings of Huang2.” slip op. at 33

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

    “We are not persuaded by Appellant’s citations to either reference. As discussed above, Petitioner’s Ground 1 is premised on a person of ordinary skill in the art altering the native flat sheet structure of Huang2 by rolling it into a jelly-roll structure as taught by Kuo. See Pet. 41 (Beginning its claim 2 arguments with the following: “Claim 1 is obvious for the reasons expressed above in § X.A., supra, which are incorporated herein.”); see also Pet. Reply 17 (“[B]ased on the explicit teaching of Kuo, a POSA would have been motivated to take the electrospun flat scaffold made by the techniques of Huang2, seed it with the desired cells, and roll it to treat a tendon and ligament.” (emphasis added)). Indeed, the paragraphs of Kuo that Petitioner cites for disclosing “scaffold sheets,” explicitly describe rolling them into jelly-roll like structures. See Ex. 1018 ¶7 (stating that “the sheet is spirally contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct”), ¶22 (describing a method comprising “forming a tissue construct by contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct” and implanting it in a patient). Petitioner fails to argue that that “one or more elongated sheets” recited in claim 2 would encompass the rolled structure of its proposed modification. Nor does Petitioner articulate a claim construction argument that could support such an argument. Petitioner has failed to prove, by a preponderance of the evidence, that claim 2 would have been obvious over Huang2 and Kuo.” slip op. at 42

  Patent outcomesUS 11,318,227 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSR
  Patents in suitUS 11,318,227
• Embody, Inc. / Zimmer Biomet Holdings, Inc. v. Lifenet HealthAll claims unpatentable
  PTAB · Aug 4, 2026 · IPR2025-00248 · APJ Michael J Fitzpatrick · IPR · Final written decision

  Claims 1–3 and 5–12 are unpatentable as anticipated by Huang2; claim 4 is unpatentable as obvious over Huang2 and Kumbar. Lee grounds failed.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 18– 19 (citing Ex. 1003 § II.C5). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 5–6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “A patentee “may choose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (citing Hoechst Celanese Corp. v. BP Chemicals Ltd., 78 F.3d 1575, 1578 (Fed. Cir. 1996)); see Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en banc) (“[A]ny special definition given to a word must be clearly defined in the specification.”), aff'd, 517 U.S. 370 (1996); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). “[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.” Bell Atlantic Network Services, Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001). Among the criteria to consider in whether the patentee acted as a lexicographer to define a claim term include (a) whether the patent specification included the statement in question under a section for marks, (c) whether the sentence uses the term “refer to,” which generally “conveys an intent for [that sentence] to be definitional,” and (d) whether there are other non-limiting terms (e.g., “for example,” or “include”) that contradict a definitional intent. Alnylam Pharms., Inc. v. Moderna, Inc., 138 F.4th 1326, 1333 (Fed. Cir. 2025) (alteration in original). At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:6–7. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at issue sets out “major peaks” in quotation marks, and then uses the term “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”).” slip op. at 8

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

    “As discussed above, we agree with Patent Owner that the sentence it cites from the Specification of the ’223 patent bears sufficient hallmarks of lexicography. However, the Specification nonetheless lacks any indication that so-called “minor peaks” are a necessary component of the claimed invention. “Although it is firmly settled that an applicant may act as a 9 Figure 8B does not contain “major peaks” despite clearly depicting two “peaks higher than the average of the [three or possibly four] peaks in the result” because none of the peaks is a reflection of fiber alignment. 10 After presenting claim construction arguments based on Ayres 2008, Patent Owner confusingly states: “Finally, whether Ayres-2008 supports [Patent Owner’s] construction is irrelevant.” PO Sur-Reply 5 (emphasis added). definition that is contrary to the ordinary meaning of a claim term unless it communicates a deliberate and clear preference for this alternative definition.” Kumar v. Ovonic Battery Co., 351 F.3d 1364, 1368 (Fed. Cir. 2003). There is no indication that the patentee sought to require “minor peaks” within the scope of the claimed invention. Nor are we persuaded that a person of ordinary skill in the art would readily understand the scope of the term “major peaks” to require non-major peaks. We interpret the Specification’s statement that “‘major peaks’ herein refer to peaks higher than the average of the peaks in the result” (Ex. 1001, 13:6–7) to be teaching a person of ordinary skill in the art how to identify or discern “major peaks,” which indicate a principal axis of alignment, from any non-major peaks, which would be caused by something else. We conclude that a person of ordinary skill in the art would consider “major peaks” as used in the ’223 patent as referring to peaks that reflect the sole axis or primary axis of fiber alignment. See, e.g., id. at code (54) (“ALIGNED FIBER AND METHOD OF USE THEREOF”), code (57) (“A scaffold comprising an aligned fiber.”), 1:6–7 (“The invention relates to an aligned fiber and method of use thereof.”), 1:11–12 (“The invention relates to a scaffold comprising an aligned fiber.”), 13:16–17 (“Alignment of the fibers in the scaffold may be measured by a fast Fourier transform (FFT) analysis.”). This would certainly include peaks materially higher than the average of the peaks in the result, but it would not be limited to situations involving peaks of different heights or require so-called minor peaks. Based on the totality of the evidence before us, we do not construe the claims to require non-major peaks.” slip op. at 16

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “Petitioner argues that, for the aligned sample, a major peak occurs at about 90° as identified by Petitioner’s annotation (red arrow). Pet. 30–31. As support, Petitioner directs us to Huang2’s explicit description of what the peak indicates, namely that “[t]he narrow peak of the normalized intensity values in anisotropic [aligned] matrices (Figure 1C) indicated that PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 31 (alterations in original) (quoting Ex. 1005, 1794). Patent Owner disputes that the illustrated peak is a major peak solely based on the lack of any lesser peaks. See PO Resp. 13 (“[T]he height of the sole peak is identical to—not higher than—the average height of the peaks in the result.”). As discussed above, however, we do not construe “major peaks” as requiring the existence of non-major peaks. We find that the illustrated peak in the Aniso plot of the FFT analysis results (Figure 1C) is a major peak within the meaning of the claim. The evidence in support of this finding is overwhelming. First, the term “Aniso” as used in Huang2 refers to fibers “with alignment.” Ex. 1005, 1792. Huang2 describes fabricating such matrices of aligned fibers with electrospinning, the same method used to impart alignment in the ’223 patent. Id. at 1791–92. Huang2 visually confirms that the fibers in fact are aligned via scanning electron microscopy. Id. at Fig. 1B. Further, Huang2 explicitly states that the peak illustrated in the Aniso plot of the FFT analysis results (Figure 1C) is caused by the fact that the “PCL/Coll nanofibers aligned along a single axis (Fig. 1B).” Id. at 1794. This is precisely what electrospinning may yield aligned fibers and images of aligned fibers will yield FFT results with major peaks. Ex. 1001, 2:18–19, 4:46–60, 13:16–26. Additionally, Huang2 itself considers the peak illustrated in the Aniso plot of the FFT analysis to be significant, stating: “In contrast [to the Aniso plot], the lack of a significant peak for the fibers collected on a stationary surface [(i.e., without electrospinning)] demonstrated no preferred fiber orientation in the isotropic matrices” (i.e., the Iso plot). Ex. 1005, 1794. Indeed, the asserted major peak in the Aniso plot shown in Huang2’s Figure 1C is higher than any other data point on the plot. For these reasons, we find the peak to be a major peak.15 Petitioner acknowledges that Figure 1C only reports its results” slip op. at 32

  Patent outcomesUS 10,137,223 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman
  Patents in suitUS 10,137,223
• 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
• 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
• Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.Instituted
  PTAB · Nov 19, 2025 · IPR2025-00947 · APJ Christopher G Paulraj · IPR · Institution

  The Board instituted review of all challenged claims and grounds, finding a reasonable likelihood that claim 1 would have been obvious over Herrstedt and Bös.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denialDenied

    “II. DISCUSSION A. Discretionary Denial Patent Owner filed a request for discretionary denial of institution. Paper 8. Petitioner opposed. Paper 9. The Acting Director denied the discretionary denial request. Paper 12 (September 19, 2025). Accordingly, we proceed with our analysis of the merits of Petitioner’s patentability” slip op. at 8

  • Skill levelOther

    “At this stage, we need not resolve the parties’ dispute with regard to the requisite level of skill in the art, as our analysis would be the same under either party’s definition of a POSA. We note, however, that Petitioner’s definition seems to be overly broad insofar as it would only require the POSA to be skilled in one of several broad fields, including “statistics” and “medical policy and decision making,” that do not directly relate to the claimed subject matter. At the same time, we do not agree with Patent Owner that the POSA needs specific clinical experience in the field of oncology. The claimed subject matter relates to the treatment of a side-effect associated with cancer therapy (CINV), and not the cancer itself. We also recognize that the prior art and the ’357 patent itself reflect the level of skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error where the prior art itself reflects an appropriate level and a need for testimony is not shown.”).” slip op. at 10

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

    “would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we construe claims “in accordance with the ordinary and customary meaning of such claim[s] as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Petitioner contends no terms need to be construed to find the claims unpatentable in view of the prior art. Pet. 9. Patent Owner also contends that no claim construction is necessary to resolve the parties’ disputes. Prelim Resp. 14. At this stage, we do not perceive a need to construe expressly any claim terms of the ’357 patent for purposes of determining whether to institute trial.” slip op. at 11

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

    “Herrstedt taught the use of aprepitant as an NK1 receptor antagonist that could be combined with dexamethasone and palonosetron to treat emesis. Nonetheless, based on Bös’s identification of netupitant (compound Ib) as a “potent and selective” NK1 antagonist with “valuable therapeutic properties,” the present record supports Petitioner’s argument that the POSA would have been motivated to replace aprepitant with netupitant in the combination therapy. Ex, 1014, 14:31–34. Bös indicates that the compounds disclosed therein have utility in the treatment of emesis, and that neutpitant in particular “is a potent antagonist of NK1 induced behaviors in Gerbil and blocks emesis in Ferrets and suncus murinus with similar potency.” Id. at 19:26–30. Bös further indicates that netupitant has a high affinity for the NK1 receptor and a prolonged half-life. Id. at 18:44–48, 19:31–38. In view of these properties, we find a POSA would have had good reason to consider netupitant as a potential replacement for aprepitant in the treatment of CINV.” slip op. at 28

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 9,186,357

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.