• 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
• Yealink (USA) Network Technology Co., Ltd. / Yealink Network Technology Co., Ltd. v. Barco NVNo claims unpatentable
  PTAB · Oct 5, 2026 · IPR2025-00598 · APJ David C Mckone · IPR · Final written decision

  Claims 1–31 were not shown unpatentable under either § 103 ground because the asserted combinations did not teach required claim limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “admissions by Patent Owner in litigation, contends that a person of ordinary skill in the art would have had “a Master of Science (M.S.) degree in electrical engineering or computer science, and five years of work experience in a related field” and that “[a]dditional educational experience could substitute for some of the work experience.” Pet. 5 (citing Ex. 1002 ¶¶ 36–37). “Patent Owner does not dispute Petitioner’s proposed level of skill in the art (Petition, 5) at this time.” PO Resp. 6. On the complete record, we adopt Petitioner’s description of the level of ordinary skill in the art, as it is uncontested and is consistent with the technology described in the ’347 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “In the Preliminary Response, “Patent Owner accept[ed] the Petition’s claim construction.” Prelim. Resp. 6. However, in the Patent Owner Response, Patent Owner argues that “the claims of the ’347 Patent require no construction as they are valid under their plain and ordinary meaning.” PO Resp. 6. Based on the complete record, we do not find it necessary to provide express claim constructions of any claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe 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 9

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Beel actually discloses the following: [0321] On the peripheral device 32 the video packets are received at the corresponding plug and play port, e.g. the USB port 11, read by the Human Interface Driver (HID) interface handler 13, unpacked to remove HID protocol headers in an unpacker 20 and then transmitted to the communications network by a transmitter 21. The network can be wireless for example WiFi or LiFi network. [0322] Having been routed over a communications network to the base unit 33, the incoming stream is read from the communications interface such as a WiFi access point 22, unpacked in an unpacker 25, decoded in a decoder 26 and then inserted into a suitable composition such as an OpenGL based composition in the compositor 29 for display on a central display device. Ex. 1005 ¶¶ 321–322 (emphasis added to portions quoted by Petitioner). Patent Owner notes that “[t]he Petition mistakenly cites to ¶ 322 of Beel but quotes ¶ 321.” PO Resp. 20 n.3. However, it appears that Petitioner has grafted together a portion of paragraph 321 that introduces peripheral device 32 with a portion of paragraph 322, which discusses features of base unit 33. However, this grafting has been done in such a way as to convey (incorrectly) that peripheral device 32, not base unit 33, includes unpacker 25, decoder 26, and compositor 29 that process the first processed video data received by the first peripheral device to generate second video data. Dr. Almeroth’s testimony, which copies Petitioner’s incorrectly altered quotation to paragraph 322 of Beel, is unreliable as to this claim limitation and is entitled to no weight.4 Thus, Petitioner has no expert testimony on which to rely for this claim limitation.” slip op. at 19

  • Strike new argumentNew argument disregardedDecided for patent owner

    “5 At the oral argument, when challenged on its reliance on paragraph 322, Petitioner argued that paragraph 321 of Beel teaches this limitation. Tr. 22:26–23:24. Petitioner did not make this argument in the Petition and, instead, raised it for the first time during oral argument; thus, it will not be considered. See Dell Inc. v. Acceleron, LLC, 884 F.3d 1364, 1369 (Fed. Cir. 2018) (“Unless it chose to exercise its waiver authority under 37 C.F.R. § 42.5(b), the Board was obligated to dismiss Dell’s untimely argument given that the untimely argument in this case was raised for the first time during oral argument.”). Even if we were to consider this new argument, it would not be persuasive. As Patent Owner observes (PO Resp. 20), any processing performed by peripheral device 32 in paragraph 321 is on data received from the processing device and destined for the base station via the network, rather than data flowing in the direction of the first processed video data of claim 1.” slip op. at 22

  Patent outcomesUS 11,966,347 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,966,347
• 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
• Yealink (USA) Network Technology Co. Ltd. / Yealink Network Technology Co., Ltd. v. Barco N.V.All claims unpatentable
  PTAB · Jul 28, 2026 · IPR2025-00491 · APJ Frederick C Laney · IPR · Final written decision

  Claims 1–18 are unpatentable as obvious over Beel and Dinka, with or without Christison; the Kaplan, Van de Laar, and Christison ground fails for lack of motivation to combine.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 9–10 (citing Ex. 1002 ¶¶ 36–37). “Patent Owner does not dispute Petitioner’s proposed level of skill in the art.” PO Resp. 6. On the complete record, we adopt Petitioner’s proposed definition of a person of ordinary skill in the pertinent art, as it is consistent with the ’972 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededPlain and ordinary meaningDecided for patent owner

    “Rather than addressing Petitioner’s proposals, Patent Owner states “the claims of the ’972 Patent require no construction as they are valid under their plain and ordinary meaning.” PO Resp. 6. Our decision in this matter does not turn on resolving any particular differences between the parties’ constructions. Therefore, because only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy, we determine that no claim term requires express construction in this proceeding and that the ordinary and customary meaning of the claim terms apply. See Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019).” slip op. at 11

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “device. The ’972 patent expressly defines endpoints broadly “as data sources or sinks.” Ex. 1001, 7:64–67. And the ’972 patent admits that Beel’s Figure 11 discloses the same endpoints depicted in the ’972 patent’s own Figure 4. Id. at 4:28–33, 16:44–67. Beel’s Figure 11 and accompanying description disclose a “[m]ass storage device 12,” a “USB audio device 14,” and a “USB HID device 13” on the peripheral device. Ex. 1005, Fig. 11, ¶¶ 320–323. Patent Owner’s own declarant conceded that a mass storage device is “a type of endpoint” (Ex. 1034, 43:19–21), and that “audio devices are endpoints” (id. at 57:5–61:4). We give reduced weight to Patent Owner’s contrary position to the extent it rests on the premise that a reference cannot disclose an endpoint unless it uses the word “endpoint” (Ex. 2030 ¶ 94; Ex. 1034, 43:19–44:16, 72:18–73:12); a premise that is inconsistent with the ’972 patent’s own broad definition and with the ’972 patent’s admission regarding Beel’s Figure 11. As additional support not separately emphasized by the parties in this connection, we note Dr. Almeroth’s technical explanation that, for data to pass from a functional device to a peripheral device, “both the functional device and the peripheral device must have ‘endpoints’”—a data source and a data sink—reasoning consistent with the ’972 patent’s definition. Ex. 1002 ¶ 125.” slip op. at 27

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

    “First, we agree with Patent Owner that, under the ordinary meaning of the claim language, the endpoint is an endpoint of the peripheral device, and that it must be “a data source or a data sink which is able to store or emit data, of the functional device exposed or made available on the first peripheral device.” Ex. 1001, 23:11–17. The limitation thus identifies a structure—an endpoint, residing on the peripheral device, that is a source or sink and that corresponds to (is “of”) the functional device—through which the communication recited in subsequent element (g) is carried out. By its terms, it imposes no requirement as to the direction in which data flows; it requires only that the endpoint be a data “source” or a data “sink” that is able to “store or emit” data. The operative transmit-and-receive communication “from the functional device to the processing device via the . . . endpoint” is recited in subsequent element (g), which we take up separately below. The disputed question under this limitation is therefore the structural one: whether Beel discloses, on the peripheral device, an endpoint that is “of the functional device.” Because the inquiry is structural and non-directional, we are not persuaded that the audio-out orientation of Beel’s described embodiment, on which Patent Owner relies, is dispositive of this limitation. device. The ’972 patent expressly defines endpoints broadly “as data sources or sinks.” Ex. 1001, 7:64–67. And the ’972 patent admits that Beel’s Figure 11 discloses the same endpoints depicted in the ’972 patent’s own Figure 4. Id. at 4:28–33, 16:44–67. Beel’s Figure 11 and accompanying description disclose a “[m]ass storage device 12,” a “USB audio device 14,” and a “USB HID device 13” on the peripheral device. Ex. 1005, Fig. 11, ¶¶ 320–323. Patent Owner’s own declarant conceded that a mass storage device is “a type of endpoint” (Ex. 1034, 43:19–21), and that “audio devices are endpoints” (id. at 57:5–61:4). We give reduced weight to Patent Owner’s contrary position to the extent it rests on the premise that a reference cannot disclose an endpoint unless it uses the word “endpoint” (Ex. 2030 ¶ 94; Ex. 1034, 43:19–44:16, 72:18–73:12); a premise that is inconsistent with the ’972 patent’s own broad definition and with the ’972 patent’s admission regarding Beel’s Figure 11. As additional support not separately emphasized by the parties in this connection, we note Dr. Almeroth’s technical explanation that, for data to pass from a functional device to a peripheral device, “both the functional device and the peripheral device must have ‘endpoints’”—a data source and a data sink—reasoning consistent with the ’972 patent’s definition. Ex. 1002 ¶ 125. Third, we find that the endpoint Beel discloses is a data source or a data sink that is “able to store or emit data, of the functional device.” We begin with the words of the limitation. The endpoint need only be “able to store or emit data”—language of capability, not a requirement that particular data actually traverse the endpoint in operation, and still less in a particular direction. And the endpoint is defined by the character of the data it handles: it is “a data source or a data sink,” which the ’972 patent instructs An audio endpoint, so understood, is characterized as an audio source or sink; its structure is not tied to any single instance of an audio device. On that understanding, Beel’s disclosure establishes the required capability directly. Beel discloses that “audio data is captured through a virtual sound card interface added as a logical device over the physical interface provided in the peripheral device,” Ex. 1005 ¶ 43, that the peripheral device “acts as a composite device comprising for instance a (virtual) audio speaker device,” id. ¶ 317, and that “audio data is captured at this interface . . . internally in the peripheral device 32” and streamed over the communications network, id. ¶ 319. Beel thus shows the endpoint on the peripheral device actually storing and emitting audio—and, correspondingly, video—data, which is the very type of data produced and consumed by the audio/visual functional devices connected to the base unit, including the microphones, cameras, speakers, and displays. Id. ¶ 120. An endpoint shown to store or emit audio and video data is necessarily one that is “able to store or emit” such data; the capability the limitation requires is thus established by Beel’s disclosure.” slip op. at 26

  Patent outcomesUS 10,684,972 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,684,972

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