- 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 - Pgr2026-00039Institution deniedPTAB · Aug 6, 2026 · PGR2026-00039 · APJ John A Squires · PGR · Director review
The Director denied institution of PGR2026-00039 after discretionary review; the opinion explaining the denial is forthcoming.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“Before JOHN A. SQUIRES, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 12,168,036 - Pgr2026-00023Institution deniedPTAB · Aug 6, 2026 · PGR2026-00023 · APJ John A Squires · PGR · Director review
The Director denied institution of PGR2026-00023 after discretionary review; the accompanying notice states that opinions for the listed discretionary denials are forthcoming.
RulingsDirector review decision- Other 314aInstitution denied discretionary otherDenied
“NOTICE Pursuant to 35 U.S.C. § 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00295 IPR2026-00297 PGR2026-00023* IPR2026-00296 PGR2026-00039* IPR2026-00330 Pursuant to 35 U.S.C. §§ 314(a), after review of discretionary” slip op. at 1
Discretionary denialPatents in suitUS 12,370,716 - Apple Inc. v. Memoryweb, LLCAll claims unpatentablePTAB · Jul 8, 2026 · PGR2022-00006 · APJ Jason M Repko · PGR · Remand
On remand, the Board held claims 1–59 unpatentable: claims 1–6, 8–37, 40–44, and 49–59 over A3UM under §103, and claims 6, 7, 38, and 39 for lack of written description under §112.
RulingsRemand decision- RemandOther
“On remand, the Board is to determine “[w]hether the alleged inconsistency in [Petitioner’s] treatment of map images compared to other first/second versions of claim elements supports rejecting [Petitioner’s] theory on claim-construction or other merits grounds is a matter for the Board to consider in the first instance on remand, constrained by any relevantly similar now-final findings of fact and conclusions of law in the ’020 PGR and related proceedings” (CAFC Dec. 16). Thus, the two issues on remand are (1) the construction of the second map image and (2) whether A3UM teaches or suggests the claimed “second map image” under that construction.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A person of ordinary skill in the art in 2011 would have had (1) at least a bachelor’s degree in computer science, computer engineering, or electrical engineering, and (2) at least one year of experience designing graphical user interfaces for applications such as photo management systems. Pet. 12 (citing Ex. 1003 ¶¶ 44–46). In the Institution Decision and Final Written Decision, we applied Petitioner’s proposed definition. Inst. Dec. 12; FWD 30–31. Patent Owner does not dispute Petitioner’s proposed level of ordinary skill in the art. PO Resp. 7. We continue to find that the skill level identified by Petitioner (Pet. 12) is consistent with the record. Thus, we use the same definition here that we used in the Institution Decision and Final Written Decision.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“c. Analysis We agree with Petitioner that the “second map image” should be construed as the map image in the second person view. Reply 5. Under Petitioner’s proposed construction, the terms “first” and “second” identify which person view that the map image is within. Id. The map image’s connection to the person view is important to how the user interacts with the interface because selecting the map image in one view does something different than selecting the map image in another, as recited in claims 14 and 46.” slip op. at 12
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“Here, we disagree with Patent Owner’s argument because it is based on the premise that the second map image is different from the first in a way that is not reflected in the claims. See Section II.C.3 supra. Even if “the claims consistently use the terms ‘first’ and ‘second’ to refer to separate and distinct elements,” A3UM’s first and second map images are separate and distinct elements for at least the reason they are included in separate and distinct views in the interface. See Pet. 63; Reply 5. As discussed in Section II.C.3, the second map image is the map image in the second person view. Here, Petitioner sufficiently shows that A3UM provides the same functionality for each person, including displaying the person in the Faces view with their name within A3UM’s overall user interface. See Pet. 62 (citing Ex. 1003, ¶215; Ex. 1005, 418–420). Patent Owner does not dispute this. See PO Resp.; Sur-reply. For the same reasons why A3UM teaches the “first map image” with respect to a first person view recited in claims 1 and 31, Petitioner has shown that A3UM also teaches the “second map image” in the second person view. See FWD 53–56. In sum, Patent Owner’s arguments are unpersuasive because they are based on an incorrect claim construction, and Petitioner has shown that claims 13 and 45 are unpatentable. 5. Claims 14–16 and 46–48 Apart from the arguments analyzed above, Patent Owner does not present separate arguments directed to the subject matter of claims 14–16 burden to show that the challenged claims are unpatentable. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). We have reviewed Petitioner’s arguments and evidence submitted in connection with the remaining limitations and find them persuasive as they are consistent with and supported by the evidence of record. See Pet. 63–64. Thus, Petitioner has shown that claims 14–16 and 46–48 are unpatentable over A3UM.” slip op. at 14
Patent outcomesUS 11,017,020 unpatentableClaim construction§ 103 obviousness§ 112 disclosurePatents in suitUS 11,017,020 - Kubota North America Corporation v. Vermeer Manufacturing CompanyAll claims unpatentablePTAB · Jun 30, 2026 · PGR2025-00016 · APJ Eric C Jeschke · PGR · Final written decision
Claims 4–14 are unpatentable: claims 4 and 7–12 as anticipated by KR996, claims 5–6 as obvious over KR996 and JP705, and claims 13–14 as obvious over KR996 and Bares.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“2. The Reasons to Combine KR996 and JP705 Petitioner provides reasons to combine KR996 with JP705. See” slip op. at 73
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusObjective indicia outweighedDecided for petitioner
“probative and cogent evidence in the record” and “may often establish that an invention appearing to have been obvious in light of the prior art was not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Thus, notwithstanding what the teachings of the prior art would have suggested to one skilled in the art, secondary considerations (objective evidence of non-obviousness) may lead to a conclusion that the challenged claims would not have been obvious. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). Our obviousness analysis includes consideration and weighing of Patent Owner’s objective indicia of non-obviousness.” slip op. at 53
- ExcludeMotion to exclude, grantedGranted in part
“For these reasons, we are persuaded by Petitioner to exclude, as” slip op. at 27
Patent outcomesUS 12,098,063 unpatentable§ 103 obviousnesscites PhillipsPatents in suitUS 12,098,063 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 · GrahamPatents in suitUS 12,123,035 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Jun 8, 2026 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1–4, 7–19, and 22 are unpatentable under § 112(a) for lack of written description and enablement, and under § 103 as obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“1. Petitioner’s Position Petitioner asserts that the “terms used in the claims are either” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“7. Analysis We find the preponderance of the evidence supports a finding that the” slip op. at 59
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the specification allegedly” slip op. at 70
Patent outcomesUS 12,018,298 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,018,298 - Pgr2026-00021Institution deniedPTAB · May 19, 2026 · PGR2026-00021 · APJ John A Squires · PGR · Director review
The Director denied institution in PGR2026-00021 after discretionary review; the notice does not identify challenged claims or a specific discretionary ground.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“Before JOHN A. SQUIRES, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. NOTICE Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of inter partes review and post-grant review is denied in the following proceedings: IPR2026-00200 IPR2026-00202 IPR2026-00223 IPR2026-00201 IPR2026-00221 PGR2026-000211 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1
Discretionary denialPatents in suitUS 12,280,146 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · May 18, 2026 · PGR2025-00006 · APJ Cynthia M Hardman · PGR · Final written decision
Claims 1–4 and 8–13 are unpatentable under §112(a) for lack of written description and enablement, and under §103 as obvious over the ’429 patent and Chao.
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 understanding of a person of ordinary skill in the art (sometimes referred to 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”) (Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 BIOCHEMISTRY 6911–20 (2007) (Ex. 1006). 5 Patent Owner withdrew the Declaration of Dr. Triggs-Raine. PO Resp. 10 n.6. herein as “POSA”) as of the effective filing date of the challenged claims. Petitioner contends that one of ordinary skill in the art would have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to study of protein structure and function (e.g., chemistry, biochemistry, biology, biophysics). From training and experience, the person would have been familiar with factors influencing protein structure, folding and activity, production of modified proteins using recombinant DNA techniques, and use of biological assays to characterize protein function, as well with techniques used to analyze protein structure (i.e., sequence searching and alignments, protein modeling software, etc.). Pet. 16.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“5. Evidence and Analysis “The construction of claims is simply a way of elaborating the normally terse claim language in order to understand and explain, but not to change, the scope of the claims.” Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000). We first turn to the intrinsic evidence because “the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). “[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Id. at 1316. [T]he definition in the patent documents controls the claim interpretation. . . . Any other rule would be unfair to competitors who must be able to rely on the patent documents themselves, without consideration of expert opinion that then does not even exist, in ascertaining the scope of a patentee’s right to exclude. Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1578 (Fed. Cir. 1995). a) Intrinsic evidence Our analysis begins with the claims and Specification of the ’262 patent. Claim 1 recites a “modified PH20 polypeptide” that also requires the polypeptide sequence is 95% identical to one of the 35 recited SEQ ID NOs and with at least one of seven amino acids at position 317 of the reference sequence. The ’262 patent states “PH20 refers to a type of hyaluronidase that occurs in sperm and is neutral-active.”7 Ex. 1001, 45:45– 46; cf. id. at 68:33–37. The ’262 patent further explains that “[r]eference to PH20 includes precursor PH20 polypeptides and mature PH20 polypeptides (such as those in which a signal sequence has been removed), truncated forms thereof that have activity, and includes allelic variants and species variants, variants encoded by splice variants, and other variants.” Id. at 45:62–67. The ’262 patent states that “PH20 polypeptides also include those that contain chemical or posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 46:4–7.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“four species tested, and particularly in a primate model that is physiologically more similar to humans, shows that a POSA would not have understood even unmodified PH20 polypeptides to provide a contraceptive effect in humans and most other species. The data Patent Owner relies upon at most shows an immunocontraceptive effect for unmodified PH20 polypeptides limited to guinea pigs. It does not evidence that a POSA would have understood that the recited modified polypeptides would provide such an effect or otherwise be useful in a contraceptive vaccine. Accordingly, even if the term “modified PH20 polypeptides” were interpreted to include inactive polypeptides that can serve as antigens to provide a contraceptive effect, the preponderance of the evidence does not show that a POSA would have understood the inventors to be in possession of the full scope of the recited polypeptides capable of such use. 7. Analysis We find the preponderance of the evidence supports a finding that the claims fail to comply with the written description requirement. “Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. In determining compliance with the written description requirement for nucleic acid genus claims, the Federal Circuit has identified two extremes. In Capon, claims relying on known nucleotide sequences with known functions were found to satisfy the written description requirement. Capon v. Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005). At the other end, Juno found that for broad claims to a nucleic acid encoding a chimeric T cell receptor with a functional requirement to bind a target, “the written description ‘must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’” Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337 (Fed. Cir. 2021) (quoting Ariad, 598 F.3d at 1349). As explained above, claim 1 requires modified PH20 polypeptides with some hyaluronidase activity. See supra Section II.B. Based on this claim interpretation, we find the evidence in this case closer to Juno than Capon, and that the ’262 patent does not disclose sufficient structural features in the PH20 sequences associated with hyaluronidase or” slip op. at 57
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the specification allegedly fails to enable the claims. We address the Wands factors and the parties’ respective arguments and evidence. a) Breadth of Claims and Nature of the Invention Dr. Park states, regarding the breadth of claim 1, that he “calculated the number of distinct polypeptides that exist that meet the specified criteria.” Ex. 1004 ¶ 173. Dr. Park’s table is reproduced below: Dr. Park’s table shows that the “number of distinct peptides is extremely large by all accounts, ranging from 1049 to 1066.” Id. Dr. Hecht agrees, stating the “sequence identity language causes the claims to encompass an immense number of distinct PH20 polypeptides.” Ex. 1003 ¶ 120. To illustrate how large a number like 1066 is, Dr. Hecht states that an “aggregate weight of the smallest set containing one molecule of each of the PH20 mutants would be . . . = 1.37 x 1027 kg. The weight of the Earth is ‘only’ ~ 5.97 x 1024 kg.” Id. ¶ 123. That is, Dr. Hecht states that a complete set of one single molecule of protein that comprises all possible mutations in PH20 as recited in claim 1 would weigh about one thousand times more than the entire mass of planet Earth. See id. In deposition, Dr. Hecht stated “my sense was that the ’262 patent lists a minuscule and highly biased sample of what would be within that fence, in the sense that it only lists single amino acid substitutions while at the same time it’s attempting to claim things that have 20 or more substitutions.” Ex. 2076, 203:6‒12. When asked if a sequence “gives you enough information to tell whether that amino acid sequence is 95 percent identical to SEQ ID NO. 3”, Dr. Hecht answered “Yes, but that’s all it tells you. It doesn’t tell you anything about active, precipitated, aggregated, folded. It doesn’t tell you anything.” Id. at 204:11‒19.” slip op. at 70
Patent outcomesUS 12,152,262 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,152,262 - Pgr2025-00087Institution deniedPTAB · May 15, 2026 · PGR2025-00087 · APJ John A Squires · PGR · Director review
The Director denied institution of post-grant review in PGR2025-00087 after reviewing discretionary and non-merits considerations.
RulingsDirector review decision- Director reviewDirector review, deniedDenied
“NOTICE Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of discretionary and non-merits considerations, institution of post-grant review is denied in the following proceedings: PGR2025-00087 Pursuant to 35 U.S.C. §§ 314(a) and 324(a), after review of” slip op. at 1
Discretionary denialPatents in suitUS 12,371,685
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.