- 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 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 - Clearcorrect Operating, LLC v. Align Technology Inc.No claims unpatentablePTAB · Sep 29, 2026 · IPR2025-00817 · APJ Kevin F Turner · IPR · Final written decision
Claims 1–20 were not shown unpatentable because the cited combinations did not teach or suggest partial insertion of new scan data into an existing 3D model.
RulingsFinal written decision- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“that Boerjes alone teaches or suggests limitation 1(h) by a preponderance of the evidence. Although the Petition is persuasive that Boerjes allows a user to “identify areas that need replacing, such as ‘a margin line’ to be removed, ‘areas of poor margin preparation,’ and ‘holes or areas of incomplete scan[s],’” and that the user can identify regions of a prepared tooth surface requiring additional preparations and “supplemental scanning” (Pet. 32 (citing Ex. 1004 ¶¶ 189, 193, 196)), Boerjes is silent with respect to replacing at least a portion of the removed surface portion of the model using the received second scan data of the patient’s teeth, per claim 1. Boerjes certainly contemplates the re-scanning of the dentition, but does not assert partial insertion of new data into an existing 3D model. We acknowledge that Petitioner has argued (Pet. 43–44) that Boerjes’ Figure 4 and paragraph 144 of Boerjes teach partial replacement, but we are persuaded that those disclosures suggest total replacement and not partial replacement. The reference to “supplemented or replaced with new scan data” (Ex. 1004 ¶ 199) does not necessarily teach or suggest partial scanning, as Petitioner has argued. Additionally, Petitioner has argued (Pet. “combining historical three-dimensional data” (quoting Ex. 1004 ¶¶ 139, 144, 163), would have suggested to ordinarily skilled artisans that “Boerjes would be used to replace at least a portion of the model with the new scan data. Id. at 45 (citing Ex. 1003 ¶ 112). These disclosures are, however, applicable to scans that create complete replacement as well as partial replacement. We remain persuaded that Boerjes does not teach partial scans used to obtain partial replacement. Even under the “comprising” language of claim 1, for example, the complete replacement of a 3D model cannot teach or suggest “replacing at least a portion of the removed surface portion” without repudiating the language of the claim by making a portion be the entire model. Even if, as Petitioner asserts, “removing portions of a virtual model has been a well-known and routine technique in 3D modeling,” and the “process of replacing a user-identified portion would have been well within the skills of a POSITA” (Pet. 35), the disclosure of Boerjes does not teach or suggest such processes. Although Boerjes allows for the possibility that portions of a model can be identified as needing replacement or supplementation, it does not disclose the partial replacement required by the instant, independent claims. Boerjes’s actual disclosure details that supplemental scanning is used to compensate for an inadequate scan, but such supplemental scanning is not disclosed to be used to stitch together before-and-after models that have undergone an intervening physical change.” slip op. at 15
Patent outcomesUS 10,791,936 not shown unpatentable§ 103 obviousnesscites KSRPatents in suitUS 10,791,936 - 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 - Intel Corporation v. Advanced Cluster Systems, Inc.All claims unpatentablePTAB · Sep 1, 2026 · IPR2025-00914 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over Menon, Trefethen, RS6000, and POEref.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and We adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the ’679 patent, the prior art of record, and the testimony of both experts.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The Petition relies on the ordinary and customary meaning of the claim terms consistent with the Phillips standard. Pet. 12–13 (citing 37 C.F.R. § 42.100(b)). The Petition also addresses the construction of “peer-to-peer architecture” recited in independent claim 1 of the ’679 patent, a limitation we need not construe to resolve the parties’ dispute in this proceeding. Id. at 13; see, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Owner relies on the ordinary and customary meaning of the claim terms consistent with the Phillips standard without further analysis. Resp. 7.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“RS6000 with Menon, namely because RS6000 provides an overview of the IBM SP2 multiprocessor and Menon teaches the use of “IBM SP2, a modern high performance distributed memory multiprocessor” used in the MultiMATLAB system. Id. at 24–25 (citing Ex. 1003 ¶¶ 142–145; Ex. 1005, 5–6, 14; Ex. 1007, 1, 11). The Petition also explains why POEref pertains to the field of cluster computing in a parallel operating environment. Id. at 26 (citing Ex.1008, 11 (“PE Software is designed to run on an … RS/6000 network cluster”)); (further citing Ex. 1001, 1:14–15; Ex. 1003 ¶¶ 146–149). The Petition contends that a POSITA would have been motivated to combine the teachings of POEref with Menon “because Menon suggests the combination by teaching that MultiMATLAB uses ‘POE, IBM's Parallel Operating Environment.’” Id. at 26–27 (citing Ex. 1005, 6); (further citing Ex. 1003 ¶¶ 150–153; Ex. 1005, 14; Ex. 1008, 11, 46). We agree with Petitioner’s analysis. We find the Petition’s argument and evidence of a motivation to combine the asserted prior art references in the manner claimed to be compelling, persuasive, consistent with the disclosures in the references, which include internal cross-references to each other, and supported by the expert testimony of Dr. Bajaj.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Patent Owner argues that Menon teaches away from a combination with Trefethen because “Menon expressly states that Trefethen’s first-generation architecture is inadequate for the objectives that motivated the newer design.” Resp. 35–37. The evidence does not support Patent Owner’s position. First, Patent Owner’s teaching away argument is inconsistent with the strong evidence of a motivation to combine Menon and Trefethen discussed above. Second, Patent Owner’s teaching away argument is contrary to the evidence of record for the reasons given in Petitioner’s Reply. Reply 13–15 (e.g., “Menon explicitly cites Trefethen and explains that Menon builds on the teachings of Trefethen.”) (citing Pet. 22; Ex. 1003 ¶ 70; Ex. 1005, 1–3; Ex. 1163 ¶¶ 47–53). We are further persuaded by Dr. Bajaj’s reply testimony: the “MultiMATLAB teachings in Trefethen. In fact, Menon describes enhancing the system of Trefethen. For example, Menon describes a list of “goals” already achieved by MultiMATLAB and then states that the architecture has been “redesigned to achieve two further goals.” One of these two “further goals” is “extensibility,” which Menon achieves by its description of adding “MEX routines” to the system of Trefethen. Far from showing an “incompatibility” between Menon and Trefethen as the POR argues, Menon’s addition of the “MEX routines” to MultiMATLAB shows that such a modification was within the capabilities of a POSITA, because the authors of the Menon paper actually implemented the modification. Ex. 1163 ¶ 49 (citing Ex. 1005, 1–3). Dr. Bajaj’s testimony is unrebutted, credible, and supported by the record. We agree with Dr. Bajaj’s reasoning, which is based on direct quotes in Menon. We further agree with Dr. Bajaj’s conclusion that Menon does not teach away from the combination with Trefethen. Id. ¶¶ 50–52. Menon’s description of building on and enhancing the teachings of Trefethen—the earlier work of the same research group at Cornell—by adding MEX routines to achieve high-performance parallel computing and extensibility for MATLAB, demonstrates a classic motivation for a POSITA to combine the teachings of Menon and Trefethen. RS6000 and POEref are specifically referenced in Menon-Trefethen and add operational details of the parallel operating platform that teach a POSITA how to implement the MultiMATLAB system with a reasonable expectation of success. Such facts are inconsistent with Patent Owner’s teaching away and lack of motivation arguments.” slip op. at 24
Patent outcomesUS 12,021,679 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 12,021,679 - 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 - Intel Corporation v. Advanced Cluster Systems, Inc.All claims unpatentablePTAB · Aug 26, 2026 · IPR2025-00913 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–30 are unpatentable: claims 1–25, 27–28, and 30 as obvious over Menon, Trefethen, RS6000, and POEref; claims 26 and 29 over those references plus MPIref.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and experience of a POSITA. We adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the ’034 patent, the prior art of record, and the testimony of both experts.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“processor,” “multi-core” processor, or “singular ‘hardware processor’ that ‘comprises’ (or ‘with’) multiple ‘processing cores’” as Patent Owner contends. Resp. 11–12, 21; see also Ex. 1163 ¶ 22 (“The claim does not recite ‘single chip,’ ‘single package,’ ‘single die,’ or ‘single multi-core microprocessor.’”). Nor do the claims recite a plurality of processing cores “within” a single-chip package or read as “multi-core within a processor” as argued by Patent Owner. Resp. 12–14; Sur-Reply 2; see Reply 6 (citing Ex. 1163 ¶ 23 (“Thus, the phrase ‘with a plurality of processing cores’ identifies the required processing resources associated with the hardware processor; it does not import a packaging limitation.”)). The claims do recite a hardware processor “with” a plurality of processing cores; a critical distinction even Patent Owner reads as open-ended, i.e., as a hardware processor that “comprises” a plurality of processing cores. See Resp. 11 (“the claims require a singular ‘hardware processor’ that ‘comprises’ (or ‘with’) multiple ‘processing cores’”). Consequently, the claim language does not support Patent Owner’s proposed construction of “a . . . hardware processor with a plurality of processing cores” as a single multi-core processor. cores it contains” in reliance on a parsed description in the ’034 patent specification: The specification explains: “Each processor can contain one or more processor cores that are capable of single-threaded execution. Processor cores are generally independent microprocessors, but more than one can be included in a single-chip package.” Id. at 1212 (partially quoting Ex. 1001, 5:11–16); Sur-Reply 2. The quoted description does not support Patent Owner’s contention that the claimed “a . . . hardware processor with a plurality of processing cores” must be limited to a “single multi-core processor” that “locates multiple cores within a ‘single-chip package,’” i.e. limited to a single multi-core microprocessor such as “a Core 2 Duo is one processor package with two cores.” Resp. 12– 13, 21 (citing Ex. 1001, 7:15–25). The description quoted above from column 5, moreover, describes a “processor” that “can contain one or more processor cores” each of which can be an independent microprocessor. Reply 2–3 (citing Ex. 1001, 5:11–16; Ex. 1163 ¶¶ 10–14). As Petitioner emphasizes, the specification distinguishes a “processor” from a “microprocessor” and describes a “processor” that “can be one or more general purpose single-core or multi-core microprocessors,” rather than limiting a “processor” to a single multi-core microprocessor. Reply 3–5 (citing Ex. 1001, 7:14–36, Fig. 1; Ex. 1163 ¶¶ 15–18).” slip op. at 13
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“art because they pertain to the same “field of cluster computing” as the ’034 patent and “are reasonably pertinent to the problem of the ’034 patent, namely, executing a single program on multiple nodes.” Pet. 22 (citing Ex. 1001, 1:14–15; Ex. 1003, ¶¶ 65–69; Ex. 1005, 2; Ex. 1006, Abstract). The Petition emphasizes that Menon expressly cites and builds on the MultiMATLAB system taught by Trefethen. Id. (citing Ex. 1003 ¶ 71; Ex. 1005, 1–2). The Petition contends that: combination of prior art elements according to known methods (executing MATLAB code on a multiprocessor system) to yield the predictable result discussed in both papers: the MultiMATLAB system executing MATLAB in parallel to perform mathematical calculations. Id. at 22–23 (citing Ex. 1003 ¶ 70; Ex. 1005, Abstract; Ex. 1006, 2–7). The Petition further contends that a POSITA would have found it predictable to combine Trefethen with Menon with a reasonable expectation of success “because researchers had a strong desire to parallelize MATLAB.” Id. at 23–24 (citing Ex. 1003 ¶ 73; Ex. 1005, 2; Ex. 1006, 11–12.)” slip op. at 27
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“A POSITA would have had an especially strong reason to read these references together because they address the same project, the same MATLAB-based parallel-computing problem, and the same MultiMATLAB command environment. Menon expressly identifies Trefethen’s MultiMATLAB work and then describes a redesigned architecture that preserves the same user-level objective––parallel MATLAB computations—while improving implementation details and extensibility. A POSITA therefore would not view the references as mutually exclusive alternatives. Rather, a POSITA would understand Trefethen as teaching specific MultiMATLAB commands and examples, including Eval, Send, Recv, and the architecture was implemented and improved in a later version. Ex. 1163 ¶¶ 71–72 (emphases added). We find the above reasoning persuasive and adopt it as our own. Petitioner and Dr. Bajaj demonstrate a sound technical motivation for a POSITA—someone having a bachelor’s degree in computer science, computer engineering, or electrical engineering and two years of experience working in the field of cluster computing or parallel processing—to combine Menon and Trefethen: to improve MATLAB’s operational performance and extensibility in a parallel operating environment. Menon builds on Trefethen to improve and extend the parallel processing capabilities of MultiMATLAB: “This system will enable users to access high-performance parallel routines from within the MATLAB environment, to extend the environment with new parallel routines, and to use these routines to develop parallel applications with the MATLAB language.” Ex. 1005 Abstract. Menon is intended to be read in conjunction with Trefethen, as would be expected from two references generated by the same research group at the same university addressed to the same technical subject matter about a year apart. Ex. 1005, 1; Ex. 1006, Ex. 1086 ¶¶ 65, 101, 102. The very first citation in Menon is to Trefethen. Ex. 1005, 2, 16.” slip op. at 30
Patent outcomesUS 11,570,034 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,570,034 - Apple Inc. v. Ferid AllaniAll claims unpatentablePTAB · Aug 25, 2026 · IPR2025-00857 · APJ Jeffrey S Smith · IPR · Final written decision
Claims 1–27 are unpatentable: claims 24 and 26 over Rossmann and Himmel; claims 1–2, 4–6, 10–23, 25, and 27 over Rossmann, Himmel, King, and Adar; claims 3 and 7–9 over those references and Boyle.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“meaning of “icon” as claimed, including the dependent claims, the specification, the prosecution history, and the extrinsic evidence including expert testimony and dictionary definitions, we determine that the plain meaning of “icon” is readily apparent from the claims themselves. See Phillips, 415 F.3d at 1314 (“In some cases, the ordinary meaning of claim language as understood by a person of ordinary skill in the art may be readily apparent even to lay judges.”). We find that the plain meaning of “icon” as claimed encompasses at least “textual elements” because claim 20 recites “the icons comprise textual elements.” See id. (“Other claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment as to the meaning of a claim term.”). We highlight that the additional intrinsic evidence cited by the parties is consistent with the plain meaning. For example, Figures 1 and 2 of the specification show icons comprising textual elements. As another example, during prosecution of the ’058 patent, the Examiner found that the claimed icons were taught by textual hyperlinks. Ex. 1002, 586, 592. In order to overcome the Examiner’s rejection and obtain an allowance (id. at 641–50), applicant subsequently amended the claims to recite “specifically designed,” thus implicitly conceding to the Examiner’s interpretation of icon as encompassing textual hyperlinks. Id. at 625–640; see PO Resp. 43–44 (citing Ex. 1002, 626–27, 645–46) (acknowledging that the Examiner allowed the claims because applicant amended the claims to recite “specifically designed for containing a set of icons.”).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed petitioner constructionDecided for petitioner
“Requiring an element to be "specifically designed" for another element narrows the claim because it requires more than the first element being merely capable of being used with the second element. The term "configured to" is generally construed narrowly to mean "made to" and "designed to" rather than broadly to require merely "capable of". See In re Giannelli, 739 F. 3d 1375, 1379-80 (Fed. Cir. 2014) (the phrase "configured to" requires more than "mere capability." Rather, that term is synonymous with "made to" and "designed to."). However, rather than use "configured to", in order to avoid any confusion as to the narrower scope of the claims as amended, Applicant herein directly and explicitly requires "designed to." In re Giannelli at 1379-80 (Fed. Cir. 2014) (reversing an obviousness rejection because (1) the claims were properly construed narrowly to mean "designed to" and not broadly to encompass merely "capable of", and (2) the USPTO had not explained the motivation for modifying the prior art to meet the "design to" requirement) See also MPEP 2111.04, citing to In re Giannelli, for the proposition that a claim can be narrowed to require that it be "designed and constructed to be used" in a specific manner (as a rowing machine in the case of In re Giannelli). Logan has not been specifically designed and constructed in the required manner, so it does not cure all deficiencies of the primary reference Iki (which lacks any tree menu structure). Logan describes only "remote web" pages 90, 95 that are merely pages retrieved from Web browsing and stored in a web computer 25. Iki as modified by Logan would result on in a tree menu structure wherein not all levels of the tree included the required selection pages specifically designed for containing the claimed set of icons. Ex. 1002, 626–27 (emphasis omitted).” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Petitioner contends that a person of ordinary skill in the art would have modified Rossmann to include several advantages expressly taught by Himmel: Himmel’s consumer hot list bookmark set for the benefits of providing a user with a consistent user interface when accessing a website; to simplify navigation for the user by providing an additional navigation aid; to provide more immediate access to commonly used web actions; to reduce the network traffic required to navigate through webpages to arrive at a particular web function; and to reduce usage charges and data usage. Pet. 22–23 (citing Ex. 1003 ¶¶ 94–99; Ex. 1004, 2:38–56, 12:24–34, 14:35–44; Ex. 1005, 18:63–65, 20:11–16). Petitioner contends that modifying Rossmann’s Figures 4A through 4G to include Himmel’s consumer hot list bookmark set yields each selection page including both selection icons for navigating to other local pages along with direct access icons such as on sale today to directly navigate to a predetermined web site to perform a common web action. Id. at 23–25 (citing Ex. 1003 ¶¶ 96–100; Ex. 1004, Figs. 4D–F). Petitioner contends that the selection page of Rossmann as modified by the bookmark set of Himmel teaches a first locally stored page specifically designed to include a direct access icon because the selection page is “used to include” a direct access icon, such as on sale today, and that during use, this selection page is programmed to display the set of direct access icons for selection by the user. Pet. 25 (citing Ex. 1003 ¶¶ 96–100); see id. at 21–24. Petitioner contends that a person of ordinary skill in the art would have had a reasonable expectation of success because technology for bookmarking websites and web actions was known at the time of invention, modifying Rossmann to utilize known bookmark manager software would have been straight forward, Rossmann already includes hardware and programming instructions to access a web server, and Himmel teaches that known prior art methods utilized both selection and direct access icons on a single page. Id. at 25–26 (citing Ex. 1003 ¶¶ 101–103; Ex. 1004, 2:38–41, 14:21–44; Ex. 1005, Fig. 6A, 21:27–34).” slip op. at 19
Patent outcomesUS 10,943,058 unpatentableClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,943,058
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.