• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Oct 15, 2026 · PGR2025-00030 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1, 2, and 6–30 are unpatentable under §112(a) for lack of written description and lack of enablement; the §103 ground was not reached.

  RulingsFinal written decision

  • Additional discoveryAdditional discovery, deniedDenied

    “Patent Owner filed a Motion for Additional Discovery (Paper 42), Petitioner opposed the motion (Paper 44), and the Board denied the motion (Paper 47).” slip op. at 3

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “of the ’758 patent supports an understanding that some activity is required for a polypeptide to be a “modified PH20 polypeptide,” and it is the enzymatic activity of hyaluronidase specifically that is the most frequently identified activity recited in the Definitions section of the ’758 patent. Indeed, both the definitions of “PH20” and “modified PH20 polypeptide” require hyaluronidase activity. See Ex. 1001, 45:54–55, 50:39–41 (“PH20 refers to a type of hyaluronidase that . . . is neutral-active” and “neutral active refers to the ability . . . to enzymatically catalyze the cleavage of hyaluronic acid at neutral pH”); 48:43–46 (“A modified PH20 polypeptide can have up to 150 amino acid replacements so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.”). Similar language is used later in the definition of a “conjugate” to explain that even when the modified PH20 polypeptide is linked to another polypeptide or chemical moiety it “retains hyaluronidase activity.” Id. at 63:39–46. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in non-definitional sections of the ’758 patent. Id. at 72:63–65, 75:60–62. Accordingly, we find that this disclosure does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–46.” slip op. at 21

  • Skill levelOther

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–251 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’758 patent.” slip op. at 56

  Patent outcomesUS 12,054,758 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,054,758
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Oct 15, 2026 · PGR2025-00024 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1, 2, 6–15, and 17–30 are unpatentable under §112(a) for lack of written description and enablement; the §103 ground was not reached.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”16) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–250 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’590 patent.” slip op. at 56

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 75

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “4. Analysis Based on the evidence of record, we agree with Patent Owner that Petitioner has not provided any persuasive reason to particularly target the leucine at position 307 of a PH20 polypeptide for modification as recited in claim 1 of the ’590 patent. It is undisputed that neither of the cited prior art references, the ’429 patent or Chao, specifically identifies or discusses position 307 of the PH20 polypeptide. See, e.g., Pet. 88‒109; PO Resp. 86‒ 93. We are not persuaded by Petitioner’s argument that multiple sequence alignments identify amino acids that are tolerated at particular positions (see Pet. 99‒109), because tolerance is not a positive reason to make a substitution. “It is not enough, even after KSR, to support a determination of obviousness that a reference includes a broad generic disclosure and a common utility to that in the claims and other prior art references—there must be some reason to select a species from the genus.” Knauf Insulation, Inc. v. Rockwool Int’l A/S, 788 F. App’x 728, 733 (Fed. Cir. 2019). Dr. Park identified 379 positions in PH20 (i.e., ~85% of the protein) with evolutionary variation, that is, where “homologous proteins have tolerated different amino acids at those positions.” Ex. 1004 ¶ 31. Dr. Park distributes the twenty standard amino acids into four categories depending on their roles in forming secondary structure such as alpha helices or beta sheets, with each category having a minimum of six members. See id. ¶ 70. Nothing in the prior art or Dr. Park’s analysis directs the ordinary artisan to position 307 itself. Although Dr. Hecht asserts that the ’429 patent suggests conservative mutations generally, Petitioner did not point us to any specific teaching or” slip op. at 126

  • Additional discoveryAdditional discovery, deniedDenied

    “Patent Owner filed a Motion for Additional Discovery (Paper 41), Petitioner opposed the motion (Paper 43), and the Board denied the motion (Paper 46).” slip op. at 3

  Patent outcomesUS 12,060,590 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,060,590
• Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,104,185
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

  Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9

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

    “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

  • BurdenNot shown unpatentable

    “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

    “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

  Patent outcomesUS 11,959,109 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 11,959,109
• Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentable
  PTAB · Sep 8, 2026 · IPR2025-00440 · APJ Tawen Chang · IPR · Final written decision

  Claim 21 is unpatentable as obvious over Mizumura with either the ’498 PCT or McClymont; the Revised Contingent Motion to Amend proposing claim 22 is denied.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “overlap to a significant degree, i.e., a person with a Ph.D. in a discipline related to biological sciences and having had at least two years of work experience. However, the parties’ proposals differ slightly in the specific subjects in which a POSA would have had a doctoral degree, and whether the person’s work experience must have been directly related to horseshoe crab Factor C. As an initial matter, we find that a rigid requirement as to the subject of a POSA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 19; Ex. 1065, 99:14–100:3. with respect to the claims of the ’318 patent would have had a Ph.D. in molecular biology, biochemistry, or a related discipline, and about two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 13

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

    “C. Claim Construction The parties agree that “the terms in claim 21 can be afforded their plain and ordinary meaning for purposes of this proceeding” without further construction. Pet. 19–20; PO Resp. 11. Because express claim construction is not needed to resolve the issues in this case, we need not, and do not, construe expressly any claim term for purposes of this Decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “Carrying Out the Invention section, that “[t]he Factor C of the present invention is a Factor C derived from a horseshoe crab,” and states later in the same section that “[e]xamples of the horseshoe crab include . . . Limulus polyphemus.” Ex. 1006, 40. However, none of the remaining portions of ’767 application cited by Patent Owner relate directly to L. polyphemus; instead, the remaining portions of ’767 application cited by Patent Owner are directed to other species, in particular the Japanese horseshoe crab T. tridentatus. Further, Patent Owner’s witness, Dr. Schaefer, conceded that the ’767 application does not contain Factor C sequence information for L. polyphemus. See, e.g., Ex. 1067, 44:25–45:23. Although “[n]o length requirement exists for a disclosure to adequately describe an invention,” Falko-Gunter, 448 F.3d at 1365–1366, we are persuaded that a POSA would not, based on the totality of the above disclosures, reasonably understand that the inventors were in possession of the claimed HEK-293 recombinant L. polyphemus Factor C protein, in view of the state of the art as of December 10, 2013. In this regard, we note that adequate written description of a biological molecule, such as a HEK293 recombinant L. polyphemus Factor C protein, requires “more than a mere statement that it is part of the invention and reference to a potential method for isolating it”; instead, what is required is “‘a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” The Regents of the” slip op. at 21

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

    “Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Neither do we see Petitioner’s arguments regarding the December 10, 2013 priority date to be “mutually opposed” as Dr. Schaefer testified. Ex. 1067, 216:4– 24. Instead, we credit evidence of record, including Dr. Jain’s testimony and the February 22, 2018 Mizumura Declaration, that existence of the full sequence would permit a more complete analysis and that such an analysis would provide a POSA with a reasonable expectation that the claimed L. polyphemus recombinant protein would have a residual activity within the claimed range. See, e.g., Ex. 1029, 2–5; Ex. 1010, 48; Ex. 1065, 117:14– 130:24 (explaining that comparison of partial sequences in the Tokunaga 1991 publication showed “difference around the cleavage site” between T. tridentatus and L. polyphemus but comparison of the full sequence revealed that “the catalytic triad of histidine, serine, aspartate . . . to be more similar between Tachypleus and Limulus”). Patent Owner asserts that “Petitioner’s reliance on a statement made by Dr. Mizumura in a declaration submitted during prosecution of the ’767 Application fails to fill the gap in the analysis” regarding reasonable expectation of success, because the declaration “offers no evidence of the percentage of conserved amino acid substitutions that exist to support the conclusion that a POSA would have expected residual activity to be maintained between Tachypleus tridentatus and Limulus polyphemus” PO Resp. 47. However, as noted above, Dr. Mizumura provides an alignment of Factor C proteins from the two different species of horseshoe crab, determines that the similarity between the amino acid sequence is 99.5%, states that the amino acid residues that can undergo N-type sugar chain that L. polyphemus, like T. tridentatus, would also be less susceptible to inhibition by ions. Ex. 1029, 4–5. For the reasons discussed above, we also disagree with Patent Owner’s assertion that Petitioner’s reasonable expectation of success argument is “nothing more than conclusory assertions with no support.” PO Resp. 46. Rather, we find Petitioner has shown, by a preponderance of the evidence, that a POSA would have had reason to combine the teachings of Mizumura and the ’498 PCT, with a reasonable expectation of success in arriving at the Factor C protein recited in claim 21.” slip op. at 38

  Patent outcomesUS 11,236,318 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 11,236,318
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · 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 · Graham
  Patents in suitUS 12,110,520
• Google LLC v. Brodti Inc.All claims unpatentable
  PTAB · Jun 30, 2026 · IPR2025-00472 · APJ Stephen E Belisle · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious under § 103 over Nicholas, Laidlaw, Mayadas, and Error, with Yasnovsky added for claims 7, 8, 16, 17, and 20.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Petitioner’s and Patent Owner’s definitions for the level of ordinary skill in the art are substantially similar. In light of the record before us, we adopt Patent Owner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’898 patent and the prior art of record, we determine that the definition offered by Patent Owner comports with the qualifications a person would have needed to understand and implement the teachings of the ’898 patent and the prior art, particularly experience pertaining to Internet/web interfaces and web-based media. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Neither party argues, nor do we determine, that the outcome of our Decision depends on which party’s definition is selected.” slip op. at 11

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

    “includ[e] a server and one or more webpages that may be provided by the server for display in a web browser.” Pet. Reply 5 (citing Ex. 1026 ¶¶ 13–15). Petitioner argues, and we agree, that the Specification strongly supports this construction (requiring a server and webpage(s)) by describing a “website” as synonymous with a server computer system: “The WWW [(World Wide Web)] service allows a server computer system (i.e., Web server or Web site) to send graphical Web pages or screens of information such as the advertising materials to a remote client computer system 10.” Ex. 1001, 3:66–4:2 (emphases added); see id. at Fig. 1 (depicting a service engine and webpages as a web server, i.e., website), 3:15–18 (describing Figure 1 as showing “a server of the website” (emphasis added)); Pet. Reply 5; see Ex. 1026 ¶ 13. Petitioner also submits a supporting (and persuasive) contemporaneous technical dictionary definition of “website,” which highlights the distinction between a lay person’s understanding of the term versus that of the relevant artisan. Pet. Reply 5–6. This definition explains that the “common but technically inaccurate” usage of “website” is to mean “Web page,” but the technically correct usage of “website” is to mean “one or more computers that are associated with a fully qualified domain name and make content available on the Web.” Id. (citing Ex. 1028, 402). Petitioner’s expert, Dr. Crovella, likewise testifies that “[a] website cannot exist without the server or computer that provides its webpages.” Ex. 1026 ¶ 15; see Ex. 1027, 36:8–20 (Patent Owner’s expert, Dr. Myler, agreeing that “it has to be some machine somewhere that’s providing the webpages for the website.”). The limitations of claim 1 also support Petitioner’s position that “website” includes a server and webpage(s). Reply 5. For example, claim 1 recites advertising material for “populat[ing] on one or more websites,” and selected “advertising buy options comprise at least one website of the respective websites.” Ex. 1001, 10:29–51 (emphases added). We find these limitations make the most technical sense where “website” implicates an Internet domain or domain name, such as brodti.com, which itself is a computer system (server) and associated webpage(s) reached via that domain name. This interpretation aligns with testimony of Patent Owner’s expert, Dr. Myler, in which he states that a “website” describes “a group of webpages at a particular domain (e.g., www.espn.com, www.espn.com/nba, www.espn.com/nfl, www.espn.com/nhl).” Ex. 2009 ¶ 68 (emphasis in italics added). In other words, brodti.com and espn.com are two different websites, with each website having one or more webpages (e.g., www.espn.com/nba, www.espn.com/nfl), and such websites include a server giving life to such webpage(s). slip op. at 15

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

    “Patent Owner proffers that placing advertising material “within” web property content means “inserting” an advertisement into particular content. PO Resp. 12. Petitioner responds that “placing . . . within” means what it says, and notes that “[t]he words ‘insert’ or ‘inserting’ appear nowhere in the [Specification].” Pet. Reply 7–8; see id. at 8 (Petitioner arguing that Patent Owner’s expert “admitted that the claim does not specify details regarding how advertising material needs to be placed within web property content.” (citing Ex. 1027, 29:18–24)). Patent Owner replies that the relevant artisan allegedly “would have understood ‘placing . . . within’ to mean ‘inserting into,’” but then submits that whether “placing . . . within” versus “inserting into” is used does not matter because Petitioner allegedly has not demonstrated the obviousness of either. PO Sur-reply 17. As Petitioner observes, “[i]t is unclear if Patent Owner intended any difference in meaning between these two terms.” Pet. Reply 8. Accordingly, based on the complete record before us, we determine that no further construction of this limitation is needed, and “placing A within B” means what it says—“placing A within B.”” slip op. at 20

  • Expert testimonyPetitioner expert creditedOther

    “determining” of impression validity feature of limitation 1[h] by disclosing “a ‘single-pixel’ image technique for determining that an impression is valid,” e.g., by using “cookies.” Pet. 42–45. Petitioner’s expert, Dr. Crovella, testifies that this “single-pixel” impression tracking technique would have been a “well-known” technique to the relevant artisan, and as described by Error, operates as follows: [A] URL link for a single pixel (or transparent) image file is embedded onto a webpage that is delivered to a web browser. The image is not meant to be viewed and will likely not be visible to the user. After the user’s browser receives the webpage, it uses the embedded URL link to request the single-pixel image from a server. The receipt of that request by the server provides an indication that the user’s web browser actually received and presented the web page to the user. Ex. 1002 ¶ 133 (citing Ex. 1007, 1:36–54, 2:6–21); see id. at ¶¶ 132–139. slip op. at 43

  Patent outcomesUS 11,416,898 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,416,898
• Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · Jun 24, 2026 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Final written decision

  Claims 1, 2, 6–14, and 16–29 are unpatentable based on written description, enablement, and obviousness grounds.

  RulingsFinal written decision

  • Director reviewDirector review, deniedDenied

    “Following institution, Patent Owner filed a Director Review Request (Paper 33), and Petitioner filed an Authorized Response (Paper 37), and the then-Acting Director issued a denial of the Director Review Request. Paper 40.” slip op. at 3

  • Additional discoveryAdditional discovery, deniedDenied

    “(Paper 46, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response (Paper 71, “Pet. Reply”), and Patent Owner filed a Sur-reply (Paper 84, “PO Sur-reply”). Patent Owner filed a motion for additional discovery (Paper 62), Petitioner opposed the Motion for Discovery (Paper 63), and the Board denied the Motion for Discovery (Paper 77).” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’035 patent.” slip op. at 53

  Patent outcomesUS 12,123,035 unpatentable
  § 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,123,035
• Palo Alto Networks, Inc. / Cisco Systems, Inc. et al. v. Centripetal Networks, Inc.All claims unpatentable
  PTAB · Jun 11, 2026 · IPR2022-01199 · APJ Kevin F Turner · IPR · Remand

  On remand, the Board held claims 1, 24, and 25 unpatentable as obvious over Buruganahalli; the copying evidence did not outweigh the strong obviousness showing.

  RulingsRemand decision

  • RemandOther

    “Scope on Remand On remand, the panel here will not address issues outside the scope of the Federal Circuit’s mandate. See Hayward Indus., Inc. v. Pentair Water Pool & Spa, Inc., 814 F. App’x 592, 597 (Fed. Cir. 2020) (“The Board is bound by the terms of a mandate issued by an appellate court. Aydin Corp. v. Widnall, 121 F.3d 726, 1997 WL 413329, at *3 (Fed. Cir. 1997). ‘Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.’ Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999).”). The sole issue on remand is whether “the evidence of copying” is sufficient to overcome the obviousness ground of unpatentability over Buruganahalli. Centripetal Networks, 19–20. We restate portions of the former Final Written Decision, as an aid to the reader, but substantially incorporate the analysis of the prior Decision below. C.” slip op. at 4

  • Director reviewDirector review, deniedDenied

    “not object to a new panel of APJs hearing this case if remanded.” Id. at 20. As such, Patent Owner requested Director Review (Paper 74), asking that the Director “de-institute,” based on an abuse of discretion. The Director (Paper 75) denied the request and directed the Board to assign a new panel on remand (see Papers 76, 77). B.” slip op. at 3

  • Skill levelOther

    “Level of Ordinary Skill in The Art We adopt the level of ordinary skill in the art adopted in the prior Decision. See Decision 25. F.” slip op. at 13

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “This argument is unpersuasive because Buruganahalli uses rules/policies to filter encrypted packets by correlating them with handshaking packets that have unencrypted data, in the same way that is done in the ‘856 Patent. The only “filtering step” in the patent that “use[s] rules to filter encrypted packets without decryption” (PO Resp. 20) is the hello message approach used, for example, at steps 19 and 23 (see id.), which is clearly disclosed in Buruganahalli.7 As explained above, the ‘856 Patent does not describe applying rules to encrypted packets. Instead, it describes (a) filtering encrypted packets by correlating them with unencrypted data in other packets and (b) by decrypting the packets and applying the rules that are recited in the claims to unencrypted data. As also explained above, the amendment added the rules of step 22, which are applied to decrypted data, to a claim that was drafted to cover filtering of encrypted packets. However, among the criteria used in the filtering performed at step 22 is a “uniform resource identifier (URI),” which, we conclude, covers Buruganahalli’s “domain name.” Thus, despite the error made during prosecution, the claims that issued cover Buruganahalli’s method of determining that a session should be filtered based on a domain name in unencrypted handshake data.” slip op. at 28

  Patent outcomesUS 9,917,856 unpatentable
  § 103 obviousness
  Patents in suitUS 9,917,856
• Palo Alto Networks, Inc. / Cisco Systems, Inc. et al. v. Centripetal Networks, Inc.All claims unpatentable
  PTAB · Jun 11, 2026 · IPR2022-00182 · APJ Kevin F Turner · IPR · Remand

  On remand, claims 1, 24, and 25 are unpatentable under § 103 over Buruganahalli; the evidence of copying does not outweigh the strong obviousness showing.

  RulingsRemand decision

  • RemandOther

    “Scope on Remand On remand, the panel here will not address issues outside the scope of the Federal Circuit’s mandate. See Hayward Indus., Inc. v. Pentair Water Pool & Spa, Inc., 814 F. App’x 592, 597 (Fed. Cir. 2020) (“The Board is bound by the terms of a mandate issued by an appellate court. Aydin Corp. v. Widnall, 121 F.3d 726, 1997 WL 413329, at *3 (Fed. Cir. 1997). ‘Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.’ Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999).”). The sole issue on remand is whether “the evidence of copying” is sufficient to overcome the obviousness ground of unpatentability over Buruganahalli. Centripetal Networks, 19–20. We restate portions of the former Final Written Decision, as an aid to the reader, but substantially incorporate the analysis of the prior Decision below. C.” slip op. at 4

  • Obviousness (§103) › Objective indicia / secondary considerations › CopyingObjective indicia outweighedNot shown unpatentable

    “given to the Eastern District of Virginia court’s opinion because it was later vacated. The district court considered all of the Read factors (applying Read Corp. v. Portec, Inc., 970 F.2d 816, 826-827 (Fed. Cir. 1992)), of which only the first factor is directed to deliberate copying, although factors 2 and 9 bear indirectly on the issue of copying. The district court determined that “[t]he fact that Cisco released products with Centripetal’s functionality within a year of these meetings goes beyond mere coincidence. Therefore, the fact that Cisco’s system mirrors the functionality of the Centripetal patents is compelling evidence that damages should be enhanced for copying.” Ex. 1027, 157. Without more, it is difficult to evaluate the processes that the district court employed to reach its determination. As the Federal Circuit instructed, we need “not [] go searching throughout the entire litigation record to find the evidence of copying, but [we have] an obligation to consider the specific evidence that was put before” us. Centripetal Networks, 19. We continue to determine that the vacated finding of the district court should be provided little weight, especially in view of the strong case of obviousness discussed above. Examination of Aaron Striegel We also do not find the Aaron Striegel’s testimony to be particularly persuasive. The testimony provides statements such as “I found evidence that it could be plausible,” “[s]o we can see the timeline is very plausible,” and “I found it very plausible that indeed that this technology could have made its way into these respective accused products.” Ex. 1029, 31:12–32:3. This testimony suggests the possibility of copying but does not demonstrate actual evidence of copying. At most, this testimony indicates that further consideration of the underlying evidence is warranted, but does little to support an ultimate finding of copying. Again, even taking this testimony as evidence of copying, it still must stand up against the strong case of obviousness discussed above.” slip op. at 40

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “The District Court did not provide an element-by-element analysis of how the claims of the ‘856 Patent cover this description. See Ex. 1027, 41. However, from the description, we understand the Court to have concluded that the system receives rules, identifies a set of packets as part of a flow using the NetFlow logs, “determines” that encrypted packets in the flow match known malicious signatures based on unencrypted data in other packets (e.g., data in the SNI), and then filters the flow based in a URI (e.g., that from the SNI), routing it to the null interface. The Court does not describe how the system “determines” that encrypted packets match known malicious signatures based on information in unencrypted packets, but we assume that is done as in the ‘856 Patent, by correlation, i.e., an encrypted packet is “determined” to match a threat indicator if it is in the same flow as a packet with unencrypted information that matches the threat indicator.10 With that understanding, we conclude that the allegedly infringing system operates, as least at the level described in the court’s decision, in the same way Buruganahalli’s system operates, filtering encrypted packets due to their presence in a flow that includes packets with unencrypted data, such as in a handshaking packet. It follows that Patent Owner is unable to establish a nexus, because “[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.” Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1330” slip op. at 38

  • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersDecided for petitioner

    “need and industry recognition for the technology claimed in the ‘856 Patent because it describes the problem of detecting threats in encrypted traffic as ‘unsolvable.’” PO Resp. 68 (citing Ex. 1027, 64). Given that this is a press release by a company announcing that company’s new commercial product, however, we 8 The concurrence reevaluates Patent Owner’s evidence of industry praise and nexus, but we deem such considerations outside the remit of the Federal Circuit’s remand. are reluctant to give the “unsolvable” characterization much weight, as it may amount to puffery. But beyond that, it appears that the problem identified as “unsolvable” in the press release––“detect[ing] known attack signatures even in encrypted traffic”––had, in fact, already been solved in Buruganahalli, using the very same hello message, flow correlation, and man-in-the-middle techniques described in the ‘856 Patent. We thus cannot say that the press release identifies a long-felt need that was actually unsolved. See ZUP, 896 F.3d at 1374 (explaining that “[w]here the differences between the prior art and the claimed invention are . . . minimal . . . it cannot be said that any long-felt need was unsolved”) (quoting Geo. M. Martin Co. v. All. Mach. Sys. Int’l LLC, 618 F.3d 1294, 1304–05 (Fed. Cir. 2010) (first alteration in original)).” slip op. at 35

  Patent outcomesUS 9,917,856 unpatentable
  § 103 obviousness
  Patents in suitUS 9,917,856

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.