• 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 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 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
  Patents in suitUS 12,264,345
• 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
• Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 12,049,652
• Netflix, Inc. v. Divx, LLCAll claims unpatentable
  PTAB · Sep 21, 2026 · IPR2020-00558 · APJ Kevin F Turner · IPR · Remand

  Claims 1–24 are unpatentable as obvious over Chen, Lindahl, and Hurst because the combination teaches the claim limitations and has motivation to combine and a reasonable expectation of success.

  RulingsRemand decision

  • RemandOther

    “On February 13, 2026, the Federal Circuit issued a decision in the appeal vacating the Second Final Decision as to all challenged claims and remanding for further proceedings. Netflix II, 7. The Federal Circuit reversed the Board’s claim construction, vacated the Board’s decision, and remanded for further proceedings consistent with the claim construction the 6 The First Final Decision also addressed Petitioner’s Motion to Exclude (Paper 42), where we granted-in-part, denied-in-part, and dismissed-in-part that Motion. See 1st Final Dec. 28–37. Our determinations on that Motion were a part of Petitioner’s appeal to the Federal Circuit. See Paper 52. As the Federal Circuit did not address this aspect of the First Final Written Decision, we determine our conclusions with respect to that Motion remain undisturbed. Federal Circuit adopted. Id. The Federal Circuit issued its mandate on March 23, 2026.” slip op. at 4

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “person of ordinary skill in the art at the time of the invention (“POSITA”) would have had “a bachelor’s degree in mechanical engineering, electrical engineering, computer science, or a similar field with at least two years of experience in video streaming and media security or . . . a master’s degree in mechanical engineering, electrical engineering, computer science, or a similar field with a specialization in video streaming and media security.” Pet. 14–15 (citing Ex. 1003 ¶¶ 65–67). Patent Owner does not refute Petitioner’s assessment and appears to apply such a level of skill in its arguments against combining Chen, Lindahl, and Hurst to teach or suggest the elements of the challenged claims. See generally PO Resp. As such, we continue to adopt and apply Petitioner’s unopposed position as to the level of ordinary skill in the art for purposes of this decision. See Inst. Dec. 6; 1st Final Dec. 6; 2nd Final Dec. 10.” slip op. at 7

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

    “In response, we conclude that the most natural reading of limitation [l] results from examination of the entire limitation: “locating encryption information that identifies encrypted portions of frames of video within the requested portions of the selected stream of protected video.” Ex. 1001, 27:54–57. The “within” most naturally connotes where the encrypted portions of frames of video occur, as opposed to determining where the encryption information may be located. Patent Owner’s interpretation is not wrong, i.e., the limitation could be read as Patent Owner suggests, leading to a narrower construction, but we are not persuaded that the construction of limitation [l] must be so limited, on the basis of the words themselves. We continue to reject Patent Owner’s interpretation that limitation [l] requires locating encryption information within the requested portions of the selected stream of protected video. See Inst. Dec. 27–30; 1st Final Dec. 8. Although it is apparent that encryption information can be found within the requested portions, we are not persuaded that the claim language or ’588 Patent implicitly or explicitly requires such a relationship. Likewise, although embodiments disclosed in the Specification of the ’588 Patent are consistent with Patent Owner’s more restrictive construction, the Specification also is consistent with the more grammatically correct construction as well. Thus, we construe limitation [l] as requiring that the encrypted portions of frames of video be within the requested portions of the selected stream of protected video, but we do not construe limitation [l] as requiring that the encryption information be within the requested portions of the selected stream of protected video.” slip op. at 15

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

    “We are persuaded that the Petition demonstrates that one of ordinary skill in the art would have had a motivation to combine Chen, Lindahl, and Hurst, as asserted by Petitioner. As the Federal Circuit found, the Petition pointed to and relied upon the portions in Chen describing pre-Chen art, without scalability or FEC features that were part of what Chen describes as aspects of its own inventive system. Netflix I, slip op. at 9–10 (citing Pet. 17–19, 69–70). We agree with Petitioner that “Chen-924 teaches several embodiments that adaptively stream alternative representations of a video using partially encrypted container files.” Pet. 20 (citing Ex. 1010, 14:41–15:60). We determine that Chen-924 provides support for the rationale provided in the Petition, and that one of ordinary skill in the art would have been motivated to combine Chen and Lindahl in view of the disclosure of Chen-924. As discussed above, the Petition does not rely solely on privacy concerns and improvements to efficiency as its motivation to combine the references. See Pet. 18–19 (specifying piracy concerns, improvements to the efficiency of adaptive streaming, optimization of the balance between bitrate and bandwidth, and improvements to the end-user experience with fast startup and seek). With respect to whether one of ordinary skill in the art would have” slip op. at 30

  Patent outcomesUS 10,225,588 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,225,588
• Apple Inc. v. Proxense, LLCAll claims unpatentable
  PTAB · Sep 17, 2026 · IPR2025-00562 · APJ Thu A Dang · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Giobbi ’157, Giobbi ’139, and Dua; the Board also finds the claims unpatentable under the Broadcom grounds.

  RulingsFinal written decision

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) does not applyDecided for petitioner

    “IPR2024-00783, Ex. 1001, 22:36–49. As the Federal Circuit stated, when a disputed claim limitation does not employ “means for” language, the presumption is that each of the terms conveys sufficiently definite structure or act and, thus, is not subject to § 112 ¶ 6. See Dyfan, 28 F.4th at 1367. Based on the record before us, this presumption that each of the terms is not subject to § 112 ¶ 6 is not overcome.” slip op. at 17

  • Skill levelOther

    “differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, “would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of non-obviousness. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).” slip op. at 25

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We find persuasive Dr. Wolfe’s supporting testimony that a POSITA would have understood the terms “PDK” and “RDC” to have “definite structure.” Ex. 1013 ¶¶ 35–56. In particular, we find persuasive Dr. Wolfe’s testimony that the term “PDK,” for example, “encompasses at least ‘a collection of circuit components that includes an antenna, a transceiver, and a controller and memory for storing information particular to a user.’” Id. ¶ 35. Dr. Wolfe’s testimony is consistent with the Specification of the ’188 patent. See Ex. 1001, 5:42–6:7, 3:48–62. In particular, the Specification of the ’188 patent describes a microchip that stores information in memory and responds through an antenna when probed, which is consistent with Dr. Wolfe’s testimony. Id.; Ex. 1001, 1:30–62.” slip op. at 19

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

    “differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, “would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of non-obviousness. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).” slip op. at 25

  Patent outcomesUS 9,049,188 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,049,188
• 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
• Palo Alto Networks, Inc. / Cisco Systems, Inc. et al. v. Centripetal Networks, Inc.All claims unpatentable
  PTAB · Jun 11, 2026 · IPR2022-01151 · 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

  • Obviousness (§103) › Objective indicia / secondary considerations › CopyingObjective indicia outweighedDecided for petitioner

    “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.” slip op. at 40

  • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia outweighedDecided 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

  • 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 10 See Ex. 1001, 9:3–10 (explaining that, at step 17, rule gate 120 may “determine . . . that the packets comprise data corresponding to the network-threat indicators, for example, by correlating the packets with one or more packets previously determined . . . to comprise data corresponding to the network-threat indicators based on data stored in [the] logs”).” slip op. at 38

  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 · IPR2022-01199 · 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

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.