- Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,054,758 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 · GrahamPatents in suitUS 12,060,590 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 2, 2026 · PGR2025-00046 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1, 2, 5, and 7–33 are unpatentable because the Petitioner proved lack of written description and lack of enablement; the Board did not find the claims 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
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”15) 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 ¶¶ 111–230 (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” slip op. at 54
- 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 74
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“E. Ground III - Obviousness 1. Principles of Law The Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398” slip op. at 117
Patent outcomesUS 12,091,692 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,091,692 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 12,264,345 - Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,104,185 - Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,049,652 - Clearwater Paper Corporation v. Graphic Packaging International LLCAll claims unpatentablePTAB · Sep 23, 2026 · IPR2025-00878 · APJ Carl M Defranco · IPR · Final written decision
Claims 1–3 and 11 are unpatentable as anticipated by Cleveland and obvious over Nakagawa and over Nakagawa combined with Tanner.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have at least a bachelor’s degree in mechanical or chemical engineering, materials science, polymer science, or equivalent coursework, at least a year of experience developing paper-based laminates involving the application of polymer coatings to a substrate, and the appropriate industry familiarity with biodegradability standards and degradability techniques [and] . . . [l]ess work experience may be compensated by a higher level of education, such as a master’s degree, and vice versa. Pet. 16 (citing Ex. 1003 ¶ 50). Clearwater’s definition is uncontested, and we apply that definition here, as it accords with the level of skill reflected in the asserted prior art and the problems addressed in the specification of the ’126 patent. C. Claim Construction” slip op. at 6
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We have reviewed the cited testimony of Clearwater’s expert, including their calculations for arriving at a coat weight in Nakagawa that falls within the claimed range. See Ex. 1003 ¶¶ 132–33. We find that testimony, which is unrebutted, both credible and supported by the evidence of record. Thus, in light of Clearwater’s contentions, the cited portions of Nakagawa, and the unrebutted testimony of Clearwater’s expert, we are persuaded that Nakagawa discloses or otherwise suggests each and every element of claim 1. See Pet. 45–54, 60–64. Clearwater also persuades us that Cleveland discloses the additional subject matter of dependent claims 2, 3, and 11. See Pet. 64–66. Thus, we determine that Clearwater demonstrates that claims 1–3 and 11 are unpatentable as obvious over Nakagawa. F. Ground 3—Obviousness Over Nakagawa and Tanner” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“qualifies as prior art under 35 U.S.C. § 102(e)(1) “based on both its provisional and non-provisional filing dates.” Inst. Dec. 4 n.5. We were persuaded by Clearwater’s proof that Cleveland’s provisional (Ex. 1006) is “virtually identical” to Cleveland itself (Ex. 1005) and that the provisional provides written description support for at least claim 1 of Cleveland. See Pet. 18–21 (citing Ex. 1006, 2–6, 9). We were also persuaded by Clearwater’s showing that the provisional provides written support for the subject matter relied upon in Cleveland. Id. at 21–40 (citing Ex. 1006, 1–9). We are still persuaded by Clearwater’s showing. Thus, we see no reason to disturb our earlier finding that Cleveland is prior art to the ’126 patent.” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“protectant layers has “a coat weight of from 5 to 30 lbs/3000 ft2.” As noted by Clearwater, Cleveland discloses a total coat weight for layers 14 and 16 as falling within the claimed range. Pet. 32–34 (citing Ex. 1005 ¶ 32). In particular, Cleveland discloses that “the coextruded layer of copolyester (irrespective of which side of the substrate the layer is disposed) is of a total coat weight of between about 10 and about 40 lb/3000 ft2 in any combination of between about 80/20 to 20/80 parts by weight of Ecoflex to Biomax,” of which “a total coat weight of 25 lb/3000 ft2 is preferred.” Ex. 1005 ¶ 32. As disclosed, Cleveland’s total coat weight range of 10–40 lb/3000 ft2 falls almost entirely within the claimed range, and the preferred total coat weight of 25 lb/3000 ft2 falls squarely within the claimed range. Thus, Cleveland satisfies claim elements [1.3.2] and [1.5.2]. See Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985) (“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is anticipated if one of them is in the prior art.”) (citation omitted). As such, we find that Clearwater adequately demonstrates that Cleveland discloses all the elements of claim 1. 4. Dependent Claims” slip op. at 12
Patent outcomesUS 8,637,126 unpatentable§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 8,637,126 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Sep 1, 2026 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1, 2, 6–15, and 17–30 are unpatentable because the challenged claims lack written-description support and are not enabled.
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 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) 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 ¶¶ 111–230 (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” slip op. at 53
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) 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 ¶¶ 111–230 (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” slip op. at 53
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“an enzyme has folded,” Dr. Naismith states, “there would need to be additional evidence to justify a conclusion that the folded enzyme is sufficiently stable to retain its folded state” and “a POSA would not believe an enzyme had ‘properly folded’ if it did not maintain activity over a meaningful period or if it formed aggregates within a short period.” Id. ¶ 59.” slip op. at 78
Patent outcomesUS 12,110,520 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,110,520 - Innoscience America, Inc. v. Infineon Technologies Americas Corp.No claims unpatentablePTAB · Jun 30, 2026 · IPR2025-00175 · APJ Jo-Anne M Kokoski · IPR · Final written decision
Claims 1–17 were not shown unpatentable because Petitioner failed to establish that Usui’s interconnect structure or Yu’s metal gate stacks satisfy the construed “electrode stack” limitation.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“(“POSITA” or “POSA”) would have had “at least a four-year degree in electrical engineering or a closely related field, and at least two years of experience in semiconductor device design,” and “[a]dditional education could substitute for professional experience and vice versa.” Pet. 6 (citing Ex. 1002 ¶¶ 80–82). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 1–76. Neither party explains why the outcome of this case would be affected by the adoption of the proffered definition of a person of ordinary skill in the art. In the Institution Decision, we adopted the assessment offered by Petitioner. Dec. 6–7. Because Petitioner’s definition of the level of skill in the art is consistent with the ’562 patent and the asserted prior art, we maintain Petitioner’s definition for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir 2001).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“comprises the recited metals and has the recited thickness, which forms an electrical contact for use on a semiconductor device generally or a group III- V semiconductor in particular. This is consistent with our determination that “electrode stack” is a conductor that provides a path for current entering or leaving a medium such as a semiconductor device We disagree with Patent Owner that “electrode stack” as used in the challenged claims should be limited to the specific electrodes shown in the embodiments described in the Specification. See PO Resp. 4–9. Although the Specification describes embodiments using source, drain, and Schottky gate electrodes as electrical contacts, we see no reason to construe the term “electrode stack” itself to be limited to these components as Patent Owner proposes. Claims 1 and 13 expressly recite that electrode stacks comprise the claimed “electrical contact,” without expressly including or precluding any specific type of electrode. Ex. 1001, 5:54–63, 6:37–47. The Federal Circuit advises that the Specification “is not a substitute for, nor can it be used to rewrite, the chosen claim language. ‘Specifications teach. Claims claim.’” SuperGuide, 358 F.3d at 875 (quoting SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 n.14 (Fed. Cir. 1985) (en banc)). The Specification does teach electrical contacts that include source, drain, and Schottky gate electrodes, but claims 1 and 13 are directed to electrical contacts that are not expressly so limited. Patent Owner’s proposed construction would effectively rewrite the claim by adding limitations, which we decline to do under the guise of claim construction. See id. (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.”). In view of the foregoing, we construe the claim term “electrode stack” to mean “a conductor that provides a path for current entering or leaving a medium such as a semiconductor device.”” slip op. at 17
- Expert testimonyPetitioner expert discountedDecided for patent owner
“that the identified layers in Usui’s interconnect metallurgy structure form an “electrode stack including a plurality of metal layers and a capping layer formed over said plurality of metal layers” as recited in claim 1. See Pet. 11–12 (citing Ex. 1002 ¶¶ 89–91). Neither Petitioner nor Dr. Zhao, however, provide adequate explanation or evidence as to why Usui’s interconnect metallurgy structure forms an “electrode stack,” i.e., a conductor that provides a path for current entering or leaving a medium such as a semiconductor device. Dr. Zhao’s testimony merely repeats the disclosures in Usui and concludes, without further technical detail, explanation, or reference to objective evidence, that Usui’s Figure 8 discloses an electrode stack. Ex. 1002 ¶¶ 89–91. Dr. Zhao’s testimony sets forth Petitioner’s conclusory assertions as though they are facts, rather than setting forth facts and evidence in support of those assertions. Compare id. with Pet. 11–12. Absent underlying facts or evidence to support Dr. Zhao’s opinion, the cited testimony “adds little to the conclusory assertion for which it is offered to support, and is entitled to little weight.” Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). In contrast, Patent Owner’s declarant Dr. Piner testifies, with evidentiary support, that interconnects (such as Usui’s interconnect metallurgy structure) and electrical contacts (such as that claimed in the ’562 patent) are not the same thing. See Ex. 2024 ¶¶ 63–70. For example, Dr. Piner explains: In other words, not all metals in a semiconductor device have the same purpose and could not be said to be interchangeable. By August 2009 it was well known to a POSA how to discern if a metal component in a transistor is an interconnect or serves as an electrical contact such as a gate contact or ohmic contact, based on the structure and functionality of the metal component. For example, interconnects are made up of metal strips and are deposited on insulators. EX-1011 (Mishra) at 216. Interconnects are low resistance conductors that can carry very high current densities. Id., 216, 217. Unlike Schottky contacts and ohmic contacts, interconnects do not provide non-linear IV response like Schottky contacts nor inject electrons and holes into semiconductors like ohmic contacts. Id., 218. As many of the references cited by Dr. Zhao illustrate, electrical contacts had their own highly complex design challenges. EX-1008 (Pearton), 41-59 (Pages 53-71 of 383) (discussing electrical contacts); EX-1017 (Kramer), 11-126 (Pages 18-130 of 151) (same). And while Dr. Zhao cites these as supporting a POSA’s knowledge of an electrical contact, none of these references describe electrical contacts as interconnects. Id. ¶ 71. Dr. Piner further testifies that Usui’s interconnect metallurgy structure is an interconnect, and not an electrical contact, because “Usui states that ‘[t]he structures fabricated by the process of the present invention are especially useful for forming electrical connections or wiring such as between active and/or passive devices of an integrated circuit structure.’” Id. ¶ 148 (citing Ex. 1004, 1:11–14) (alteration in original); see also id. ¶¶ 150– 151 (Dr. Piner testifying that Usui’s interconnect metallization structure is not an “electrode stack” under a broad definition of electrode). Dr. Piner’s testimony in this regard rebuts Petitioner’s and Dr. Zhao’s conclusory assertions to the contrary.” slip op. at 21
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“conductor that provides a path for current entering or leaving a medium such as a semiconductor device.” Thus, Petitioner must show that Usui’s layers 13–15, 18, and 19 provide a path for current entering or leaving a medium such as a semiconductor device. After reviewing the complete trial record, we are not persuaded that Petitioner has done so. Petitioner relies on the testimony of Dr. Zhao to support its contention that the identified layers in Usui’s interconnect metallurgy structure form an “electrode stack including a plurality of metal layers and a capping layer formed over said plurality of metal layers” as recited in claim 1. See Pet. 11–12 (citing Ex. 1002 ¶¶ 89–91). Neither Petitioner nor Dr. Zhao, however, provide adequate explanation or evidence as to why Usui’s interconnect metallurgy structure forms an “electrode stack,” i.e., a conductor that provides a path for current entering or leaving a medium such as a semiconductor device. Dr. Zhao’s testimony merely repeats the disclosures in Usui and concludes, without further technical detail, explanation, or reference to objective evidence, that Usui’s Figure 8 discloses an electrode stack. Ex. 1002 ¶¶ 89–91. Dr. Zhao’s testimony sets forth Petitioner’s conclusory assertions as though they are facts, rather than setting forth facts and evidence in support of those assertions. Compare id. with Pet. 11–12. Absent underlying facts or evidence to support Dr. Zhao’s opinion, the cited testimony “adds little to the conclusory assertion for which it is offered to support, and is entitled to little weight.” Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential).” slip op. at 21
Patent outcomesUS 8,686,562 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,686,562
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.