- 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 · PGR2025-00033 · 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 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Stingray Group Inc. / Stingray Music USA, Inc. v. Edwin A. Hernandez-MondragonSome claims unpatentablePTAB · Jun 10, 2026 · IPR2025-00350 · APJ Jason M Repko · IPR · Final written decision
Claims 7–12 were held unpatentable over Wannamaker alone or with Avellan; claims 1–6 and 13 were not shown unpatentable because Avellan did not teach the claimed screen-capture sequence and assembly.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Patent Owner submits a similar definition and does not take issue with the Petition’s characterization of the level of ordinary skill in the art. PO Resp. 17. We determine that no express finding is necessary and that the level of ordinary skill in the art is reflected by the prior art of record. Any perceived difference in how each party characterizes a POSITA’s education, knowledge, and work experience does not change our analysis or conclusions.” slip op. at 5
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party has offered any claim construction arguments, relying on ordinary and customary meaning. Pet. 19–20; PO Resp. 18. We determine that construction of claim terms is not necessary to resolve the disputes raised by the parties in this proceeding.” slip op. at 5
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Yet paragraph 122 of Mr. Lipoff’s declaration merely repeats the Petition’s argument almost verbatim. Compare Ex. 1007 ¶ 122, with Pet. 28. Mr. Lipoff does not add any citation to Avellan or any other source that supports his testimony. See Ex. 1007 ¶ 122. Nor does Mr. Lipoff offer any additional technical reasoning than what is stated in the Petition. Testimony may be entitled to little weight if it merely restates the petition’s unsupported, conclusory assertions without adding supporting evidence or technical reasoning. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). That is the case here.” slip op. at 8
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We are persuaded by Patent Owner’s argument that claim 1 is not obvious over Avellan because it does not assemble a media stream of multimedia items using the recited screen captures. See PO Resp. 21–23. We agree with Patent Owner that the plain language of the claim requires more than transmitting individual media items. PO Sur-reply 20. To the extent that Avellan captures images, those images do not meet the claimed requirements for a “temporal sequence of screen captures” in the independent claims, which must (1) be of the web page rendered by a browser, (2) “define all the content of the web page at a given time,” (3) “illustrate a dynamic change of at least a portion of the content over time” when two of them are compared, and (4) used to assemble “the at least one media stream.” Rather, the record better supports Patent Owner’s argument that Avellan transmits the multimedia items separate from any media stream assembled from screen captures. PO Resp. 21–23; PO Sur-reply 20.” slip op. at 7
Patent outcomesUS 10,524,002 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 10,524,002 - Stingray Group Inc. / Stingray Music USA, Inc. v. Edwin A. Hernandez-MondragonNo claims unpatentablePTAB · May 29, 2026 · IPR2025-00349 · APJ Jason M Repko · IPR · Final written decision
Claims 1–21 were not shown unpatentable because Avellan did not disclose the claimed sequence of screen captures used to assemble a media stream.
RulingsFinal written decision- Skill levelOther
“Patent Owner submits a similar definition and does not dispute the Petition’s characterization of the level of ordinary skill in the art. PO Resp. 22. No express finding is necessary. The level of ordinary skill in the art is reflected by the prior art of record. Any perceived difference in how each party characterizes a POSITA does not change our analysis or conclusions.” slip op. at 5
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“on ordinary and customary meaning. Pet. 14–15; PO Resp. 22. We determine that construction of claim terms is not necessary to resolve the disputes raised by the parties in this proceeding.” slip op. at 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“c. Analysis “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987). We are persuaded by Patent Owner’s argument that Avellan does not anticipate claim 1 because it does not assemble a media stream of multimedia items using the recited screen captures. See PO Resp. 26–29. We agree with Patent Owner that the plain language of the claim requires more than transmitting individual media items. Sur-reply 21. To the extent that Avellan captures images, those images do not meet the claimed requirements for a “temporal sequence of screen captures” in the independent claims, which must (1) be of the web page rendered by a browser, (2) “define all the content of the web page at a given time,” (3) “illustrate a dynamic change of at least a portion of the content over time” when two of them are compared, and (4) used to assemble “the at least one media stream.” Rather, the record better supports Patent Owner’s argument that Avellan transmits the multimedia items separate from any media stream assembled from screen captures. PO Resp. 26–29; Sur-reply 21.” slip op. at 8
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“All other challenged claims require the “generating” and “assembling” operations because they depend from claims 1, 12, or 17. Petitioner does not allege that the additional references—Durante, Ma, Suzuki, Wanamaker, Heikens, Matthews, or Wilsher—teach or suggest the “temporal sequence of screen captures” recited in claim 1. Rather, Petitioner’s reasoning in the challenges to the dependent claims pertaining to the screen captures mirror the rationale presented in the independent claim. See, e.g., Pet. 25 (arguing that Avellan’s screen captures correspond to the video content in the challenge to claim 2), 26–27 (arguing that Avellan obtains screen captures from a playback of a video on the webpage in the challenge to claim 4). Petitioner’s argument that Avellan teaches or suggests these operations in the grounds based on obviousness under 35 U.S.C. § 103 depend on the reasoning and insufficiently supported characterizations of Avellan in the challenges based on 35 U.S.C. § 102, as discussed above. See Pet. 40–60. grounds based on anticipation under 35 U.S.C. § 102 or teaches or suggests these operations in the grounds based on obviousness under 35 U.S.C. § 103, Petitioner has not met its burden to show that any challenged claim is unpatentable as anticipated by Avellan or obvious over any of the combinations of Avellan and the other cited references.” slip op. at 15
Patent outcomesUS 10,123,074 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,123,074 - Stingray Group Inc. / Stingray Music USA, Inc. v. Edwin A. Hernandez-MondragonSome claims unpatentablePTAB · May 28, 2026 · IPR2025-00351 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–9 are unpatentable as obvious over the stated combinations; claims 10–26 were not shown unpatentable because Avellan does not teach limitations [10d]–[10f].
RulingsFinal written decision- Skill levelOther
“would have a bachelor’s or equivalent degree in computer science or a related field and at least 2 years of experience in multimedia processing or delivery using internet protocols.” Pet. 10 (citing Ex. 1002 ¶¶ 67–68). The Petition further states that “a person with less formal education but more experience, or more formal education but less experience, could have also met the relevant standard for a POSITA.” Id. Patent Owner submits a similar definition and does not take issue with the Petition’s characterization of the level of ordinary skill in the art of delivering multimedia content. Resp. 18. We determine that no express finding is necessary and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Any perceived difference in how each party characterizes a POSITA’s education, knowledge, and work experience does not change our analysis or conclusions. slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Neither party has offered any claim construction arguments, relying on ordinary and customary meaning. Pet. 11; Resp. 18–19; Reply 5. We determine that construction of claim terms is not necessary to resolve the disputes raised by the parties in this proceeding. 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., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentableNot shown unpatentable
“To establish inherency, the extrinsic evidence “must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991). “‘Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.’” Id. at 1269 (quoting In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981)). Reasonable inferences of a POSITA may suffice to establish inherent disclosure in a prior art reference such as Farber. See Eli Lilly v. Los Angeles Biomedical Research Institute, 849 F.3d 1073, 1074–1075 (Fed. Cir. 2017) (“[T]he dispositive question regarding anticipation is whether one skilled in the art would reasonably understand or infer from a prior art reference that every claim element is disclosed in that reference.”). Here, however, we find the Petition’s argument and evidence insufficient to establish by a preponderance of the evidence that Farber inherently discloses limitation [1b].” slip op. at 16
Patent outcomesUS 11,140,441 mixedClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 11,140,441 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · May 12, 2026 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1–4 and 8–21 are unpatentable for lack of written description and enablement; obviousness over the ’429 patent and Chao was not shown.
RulingsFinal written decision- Skill levelSkill level board ownOther
“VII. 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 petitioner constructionDecided for petitioner
“term “modified PH20 polypeptide” in the ’600 patent supports the understanding that some type of activity is required for a polypeptide to be a “modified PH20 polypeptide”, and that the enzymatic activity of hyaluronidase is the most frequently identified activity recited in the definitions section of the ’600 patent. Id. at 48:38–53, 50:9‒17, 51:15‒18, 52:41–47, 55:9–23, 63:37–44, 64:14–19. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in a non-definitional section of the ’600 patent. Id. at 75:56–58, 72:60–62. Accordingly, it does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–53.” slip op. at 19
- 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) 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. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–12 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’600 patent.” slip op. at 51
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“8. Conclusion We find that the balance of evidence supports a finding of undue” slip op. at 101
Patent outcomesUS 11,952,600 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,952,600 - Illumina, Inc. v. Molecular Loop Biosciences, Inc.No claims unpatentablePTAB · Apr 15, 2026 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–9 were not shown unpatentable because the asserted references failed to disclose the claimed correcting step, and Chee was not prior art to claims 1–3 and 9.
RulingsFinal written decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“We have considered both parties’ arguments and evidence and determine that Patent Owner has presented sufficient evidence of reasonable the invention to practice every day during the critical period in order to demonstrate reasonable diligence. See Perfect Surgical Techniques, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1009 (Fed. Cir. 2016). “[D]iligence need not be perfectly continuous—only reasonably continuous.” Arctic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1331 (2019). The key question is whether, “in light of the evidence as a whole, the invention was not abandoned or unreasonably delayed.” Id. (internal quotations omitted). Applying this standard, we determine that Patent Owner sufficiently demonstrates reasonably continuous diligence throughout the critical period.” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“introduced during said workflow by collapsing target:differentiator tag combinations observed more than once into a single count.” Ex. 1001, 131:46–48 (emphasis added). The “determining step” of claim 2 recites “determining a consensus base call for the target nucleic acid molecule sequences,” but performs “collapsing all sequence reads comprising a same differentiator tag into a single read,” before the “determining step.” Id. at 131:49–53. Patent Owner proposes an interpretation of these “collapsing” and “determining” steps recited in claims 1 and 2 and asserts that they should be construed as distinct steps performed in a particular order in which the “collapsing step” is performed before the “determining step.” PO Resp. 42–45. We agree. First, Patent Owner asserts a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from, and must occur before, the “determining step” of claim 2 based on the plain language of claims 1 and 2. PO Resp. 42–43. Patent Owner argues that the “collapsing step” and the “determining step” are distinct steps because claims 1 and 2 use different terms to describe these distinct steps that are performed sequentially according to the claim language. Id. (citing Ex. 1001, 131:47–54; Ex. 2023 ¶ 133; Ex. 2024, 57:11–58:22). More specifically, Patent Owner explains that claim 1 recites a “collapsing step,” followed by claim 2, which depends from claim 1 and refers to “collapsing” before “determining a consensus base call” such that “claim 2 describes determining a consensus base call from collapsed reads, not performing ‘collapsing’ by determining a consensus base call.” Id. at 42 (citing Ex. 1001, 131:47–54). collapsing corrects for skewing, an issue related to over- or under-amplification, which is a separate and distinct problem from the sequence errors that a consensus base call is designed to address.” Id. at 43 (citing Ex. 1001, 27:47–50, 32:29–34). Patent Owner contends further that “‘[c]ollapsing’ is a different step, performed separately from determining any consensus base call, to provide even greater accuracy when subsequently determining a consensus base call” such that “if one were to collapse by determining the consensus base call, errors from amplification bias could still be represented in the consensus base call generated.” Id. at 43–44 (emphasis omitted, citing Ex. 2023 ¶¶ 134–37). Second, Patent Owner argues a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from the “determining step” based on the specification of the ’730 patent. PO Resp. 43–45. For example, Patent Owner explains that the specification states that “[f]or any target:differentiator tag combination observed more than once, all such reads are ‘collapsed’ into a single read before consensus basecalls are determined. This will cancel the effect of bias on consensus basecall accuracy.” Id. at 43 (emphasis omitted) (quoting Ex. 1001, 72:63– 73:5) (citing Ex. 2023 ¶¶ 133, 138–142).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We have considered both parties’ arguments and evidence and agree with Patent Owner’s position. As discussed above, we agree with Patent Owner that the “collapsing step” recited in claim 1 and the “determining step” recited in claim 2 are two different steps required by the challenged claims such that “collapsing” does not mean determining a consensus base call or sequence, and must occur before any determining step. As a result, we determine Chee’s step of determining a consensus sequence does not disclose the “collapsing step” recited in claim 1 that requires collapsing “target:differentiator tag combinations.” We are also unpersuaded by Petitioner’s reliance on Chee’s process of correcting for amplification bias as disclosing the claimed collapsing step. As recognized by Patent Owner, the claim language of the “collapsing step” requires “collapsing target:differentiator tag combinations,” rather than collapsing only differentiator tags. In view of this requirement, Chee does not disclose the “collapsing step” because Chee teaches quantifying the starting nucleic acid molecules using their unique identifiers, rather than target:differentiator tag combinations. As Petitioner admits, “Chee’s technique for correcting amplification bias corrects quantitative errors without correcting sequencing errors” (Reply 15), whereas claim 1’s “collapsing step” corrects both quantitative errors and sequencing errors by using target:differentiator tag combinations. See Ex. 1001, 131:47–49 target:differentiator tag combinations).” slip op. at 41
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Given this claim interpretation requiring collapsing target:differentiator tag combinations, it is undisputed that McCloskey, who uses unique barcodes alone, does not teach this limitation. Petitioner does not rely on Bignell as teaching this collapsing step. Accordingly, we conclude Petitioner has not shown that the combination of Bignell and McCloskey teaches the “collapsing step” recited in claim 1. Because claims 4 through 6 depend from claim 1, they also require the “collapsing step” of claim 1 that is not taught by the combination of Bignell and McCloskey.” slip op. at 54
Patent outcomesUS 11,840,730 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,840,730 - Samsung Display Co., Ltd. v. Pictiva Displays International Ltd.No claims unpatentablePTAB · Mar 4, 2026 · IPR2024-01223 · APJ Garth D Baer · IPR · Final written decision
Claims 34–37 and 40–46 were not shown unpatentable because Suzuki’s organic barrier layer was not shown to meet the agreed construction of “planarization layer.”
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for patent owner
“layer of material that planarizes such that the propagation of defects from one layer to another layer can be interrupted and the topography of the underlying layer and/or structure is not reproduced.” PO Resp. 10. According to Patent Owner, we should adopt this construction because the parties agreed to it in a related district court proceeding and it is supported by the intrinsic evidence. Id. at 10–14. Petitioner does not dispute this 1 Japanese Published Application No. H09-245964, Pub. Sep. 19, 1997 (Ex. 1010, “Kijima”) (English translation). 2 US 6,198,217, Pub. Mar. 6, 2001 (Ex. 1012, “Suzuki”). 3 US 6,087,196, Pub. July 11, 2000 (Ex. 1013, “Sturm”). 4 WO 2001/08242, Pub. Feb. 1, 2001 (Ex. 1016, “Duthaler”). 5 Japanese Published Application No. H10-41069, Pub. Feb. 13, 1998 (Ex. 1014, “Fujimori”) (English translation). construction. Paper 33, 6:17–8:1; see Pet. Reply 5. We adopt the parties’ agreed-to construction.” slip op. at 4
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Petitioner argues Suzuki’s organic barrier layer does not reproduce the underlying layer’s/structure’s topography because “Suzuki’s organic barrier layer 20 ‘makes a smooth surface on the relatively irregular surface of the cathode 18.’” Pet. Reply 7 (quoting Ex. 1012, 5:59–67). We disagree. Instead, we agree with Patent Owner that Suzuki’s irregular-surface smoothing describes covering defects, not suppressing the underlying cathode’s topography. PO Sur-reply 5. The smooth-surface passage that Petitioner highlights comes immediately after two sentences describing inevitable “defects,” “pinholes,” and “foreign matter” on the cathode surface and before a sentence describing “ensuring the formation of the layer 22, which is substantially defect-free.” Ex. 1012, 5:52–67. Suzuki’s organic barrier 20 “makes a smooth surface” by covering defects because the defects are the only source of the “irregularity” that Suzuki refers to here. Id. We note Mr. Humphrey’s testimony, which we credit in this regard, that the “defects are created incidentally on the surface of the underlying layer and are generally not considered to be part of the underlying layer’s topography, which is a macroscopic property by design” and that the organic layer is not a planarization layer because it would reproduce the topography of the underlying layer. Ex. 2018 ¶¶ 47–48. Because the parties’ agreed-to construction of “planarization layer” “requires ‘a layer of material that planarizes’ for two distinct functions,” Petitioner’s showing of just one of those functions is insufficient. PO Sur-reply 2.” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“G. Level of Skill in the Art Petitioner argues a person of ordinary skill in the art “would have had a bachelor’s degree in Electrical Engineering, Materials Science, or a related field, and at least one year of experience in display technologies” and that “[a]dditional education might compensate for a deficiency in experience, and vice-versa.” Pet. 14–15. Patent Owner does not dispute the level of ordinary skill in the art. We agree with and adopt Petitioner’s proposal as reasonable and consistent with the level of skill reflected in both the prior art and the ’389 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 6
- Expert testimonyPatent owner expert creditedDecided for patent owner
“which is substantially defect-free.” Ex. 1012, 5:52–67. Suzuki’s organic barrier 20 “makes a smooth surface” by covering defects because the defects are the only source of the “irregularity” that Suzuki refers to here. Id. We note Mr. Humphrey’s testimony, which we credit in this regard, that the “defects are created incidentally on the surface of the underlying layer and are generally not considered to be part of the underlying layer’s topography, which is a macroscopic property by design” and that the organic layer is not a planarization layer because it would reproduce the topography of the underlying layer. Ex. 2018 ¶¶ 47–48. Because the parties’ agreed-to construction of “planarization layer” “requires ‘a layer of material that planarizes’ for two distinct functions,” Petitioner’s showing of just one of those functions is insufficient. PO Sur-reply 2.” slip op. at 9
Patent outcomesUS 6,949,389 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 6,949,389
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.