- Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 12,104,185 - Merck Sharp And Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Sep 25, 2026 · PGR2025-00033 · APJ Michael A Valek · PGR · Final written decision
Claims 1, 2, and 6–29 are unpatentable for lack of written description and enablement; the Board did not find them obvious over the ’429 patent and Chao.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“structural connections and three-dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 126–212, 297–342; Ex. 2068 ¶¶ 123–125, 245, 294–313, 318) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’652 patent.” slip op. at 58
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Decided for petitioner
“exclude the use of modified PH20 polypeptides as contraceptives—the only other possible utility described in the ’652 patent—is unavailing. Resp. 39. First, “[t]he fact that a patent asserts that an invention achieves several objectives does not require that each of the claims be construed as limited to structures that are capable of achieving all of the objectives.” Phillips, 415 F.3d at 1327 (citing Liebel–Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 908 (Fed. Cir. 2004)). Second, unlike the definitions of “PH20” and “modified PH20 polypeptide” in the “Definitions” section of the Specification, the passages describing possible contraceptive use do not contain any characteristics suggesting they are definitional in nature. See Alnylam, 138 F.4th at 133 (enumerating “characteristics” such as the fact that the text appears in the “Definitions” section, sets the term off in quotation marks, and uses phrases like “refer to” that indicate that specification language is definitional in nature). Accordingly, the statement that “[a]lso provided are modified PH20 polypeptides that are inactive, and that can be used, for example, as antigens in contraception vaccines” (Ex. 1001, 75:56–58), does not redefine the term, nor otherwise void the definitional language in the Specification stating that a “modified PH20 polypeptide can have up to 150 amino acid replacements, so long as the resulting modified PH20 polypeptide exhibits hyaluronidase activity.” Id. at 48:47–49 (emphasis added).” slip op. at 26
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“1352. While a POSA might be able to embark on their own research program to try to find the genus of multiply-modified PH20 polypeptides recited in the challenged claims, the four corners of the written description here do not demonstrate the inventors were in possession of such. See id. at 1356–57 (recognizing that “[p]erhaps one of ordinary skill could discover this information, but this does not alter our conclusion that the description . . . just represent a wish or arguably a plan for future research”) (internal quotation omitted).” slip op. at 68
Patent outcomesUS 12,049,652 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,049,652 - Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco Limited And Willow Innovations, Inc.All claims unpatentablePTAB · Sep 25, 2026 · IPR2025-00554 · APJ Barry L Grossman · IPR · Final written decision
Claims 17–19 and 21–33 are unpatentable as obvious under each asserted § 103 ground.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Factors pertinent to a determination of the level of ordinary skill in the art include: (1) educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of workers active in the field. Env’t Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case. Id. Moreover, these factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art. Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). In determining a level of ordinary skill, we also may look to the prior art, which may reflect an appropriate skill level. Okajima, 261 F.3d at 1355.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“according to the Phillips standard,” and that “no formal claim constructions are necessary for purposes of resolving controversies in this proceeding. Pet. 3. We agree. Given the lack of dispute on this record, we do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 18
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We find Mr. Bauer’s testimonial evidence persuasive and undisputed as to why a person of ordinary skill, a degreed engineer with two years of experience designing human breast pump equipment, would modify Furrer to use a battery as a power source, and have a reasonable degree of confidence that it would work successfully.” slip op. at 26
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We find Mr. Bauer’s testimonial evidence persuasive and undisputed as to why a person of ordinary skill, a degreed engineer with two years of experience designing human breast pump equipment, would modify Furrer to use a battery as a power source, and have a reasonable degree of confidence that it would work successfully. Concerning the proposed combination of Furrer and Alvarez, Mr. Bauer testifies why a person of ordinary skill would combine Furrer and Alvarez, explaining that: a POSITA6 would have turned to the teachings of Alvarez to implement Furrer’s vacuum pump using a conventional pump controller having a portable, battery-powered pump to not only increase portability and to allow the user to move about when using the device but also to provide improved control for the system. Ex. 1003 ¶ 138. Mr. Bauer also testifies: a POSITA would have recognized that Alvarez advantageously provides details for such a conventional vacuum pump suitable for safely and controllably delivering negative pressure using a “[c]ontroller 115 [that] “houses the power source and drive mechanism for pumping device 100, and also contains hardware for various functions, such as controlling pumping device 100, milk production quantification, and communication with other devices. 6 “POSITA” is a patent law acronym for a “person of ordinary skill in the art.” Id. ¶ 139 (citing Ex. 1005 ¶ 69). Mr. Bauer further explains that Alvarez discloses that a “pump unit2100 [disclosed in Alvarez] preferably include[es] a controller and processor 2104 as well as a motor 2102 for actuating the device.” Id. (citing Ex. 1005 ¶ 115); see also id. ¶¶ 140–142 (providing “second,” “third,” and “fourth” reasons why a person of ordinary skill would have been motivated to combine Furrer and Alvarez). Mr. Bauer concludes from his analysis that “a person skilled in the art” slip op. at 26
Patent outcomesUS 11,806,454 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,806,454 - Netflix, Inc. v. Divx, LLCAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,225,588 - Apple Inc. v. Proxense, LLCAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,049,188 - Microsoft Corporation v. Sterling Computers CorporationAll claims unpatentablePTAB · Sep 14, 2026 · IPR2025-00270 · APJ Bach V Hoang · IPR · Final written decision
Claims 1–13, 15, 18, 20, 21, and 27 are unpatentable as obvious over Rohall and Schiavone, with Gomes added for claims 9 and 27.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Our Institution Decision adopted Petitioner’s definition of a person of ordinary skill in the art. Inst. Dec. 9–10. In its Response, Patent Owner adopts Petitioner’s proposed level of ordinary skill. See PO Resp. 16 (“Patent Owner and its expert adopt the Board’s definition for purposes of this Response.”). Having considered the record, we continue to adopt Petitioner’s proposed level of skill, as articulated above. We are satisfied that Petitioner’s proposal comports with the level of skill necessary to understand and implement the teachings of the ’911 Patent. Accord Inst. Dec. 9–10.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We agree with Petitioner and determine that the construction of “relational references” does not require the use of a relational model and, further, includes pointers that point to related messages exchanged among users. The intrinsic evidence leads us to this construction. First, the relevant language of claim 1 recites “a message container containing relational references pointing to a plurality of sent submessages stored externally to the message container in the message database.” Ex. 1001, 15:56–59. A relational model is not recited in that language or anywhere else in the claim. See id. at 15:51–16:14. Therefore, the claim does not expressly require a relational model. Furthermore, the claim language supports Petitioner’s interpretation that “relational references” include pointers that point to related messages because the claim states that the “relational references” perform the task of “pointing to a plurality of sent submessages.” Pet. Reply 7. Accordingly, the language of the claim supports a construction that does not require a relational model and at least suggests relational references include pointers.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“No other claim terms need construction for our decision here and we decline unnecessarily doing so. 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 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentableDecided for petitioner
“We agree with Petitioner that the ordinarily skilled artisan would have been motivated to combine Rohall and Schiavone because Schiavone provides reasons to apply its techniques to email systems such as Rohall’s. Schiavone describes a need for “ensuring compliance of e-mail messages with applicable standards and/or laws and/or otherwise determining appropriateness of a message for an intended recipient,” especially because there is “a patchwork of local, federal and international laws.” Ex. 1006 ¶ 6. Schiavone also states that filtering emails, e.g., to remove spam, is beneficial. Id. ¶¶ 1–2. As Schiavone describes problems in email systems, which its rules-based email processing technique addresses, we determine that the ordinarily skilled artisan would have been motivated to combine Rohall and Schiavone. See KSR, 550 U.S. at 401 (a reference which teaches, suggests, or motivates its combination may “identify a reason that would have prompted a person of ordinary skill in the art to combine the elements”).” slip op. at 19
Patent outcomesUS 8,073,911 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 8,073,911 - ARM Ltd v. Daedalus Prime LLCAll claims unpatentablePTAB · Sep 9, 2026 · IPR2025-00207 · APJ Gregg I Anderson · IPR · Final written decision
Claims 1–7, 11–14, and 16–19 are unpatentable as obvious over the asserted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have (1) at least a bachelor’s degree in electrical engineering, computer engineering, physics, or a similar field, and (2) approximately two years of industry or academic experience in a field related to microelectronic architecture design, including experience with cache management in multicore systems-on-a-chip (SoCs). (Ex-1003 ¶¶50-51.) More related education would compensate for fewer years of work experience (and vice versa). (Ex-1003 ¶¶50-51.) Pet. 4–5. This definition was adopted in the Institution Decision. Inst. Dec. 13. Patent Owner does not dispute the finding. PO Resp. 5–6. For the purpose of our Decision, we maintain the finding made in the Institution Decision.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“1. “a single caching agent” (claim 1) We note a construction issue from the ’1344 IPR where we construed a “single caching agent,” which is recited in claim 1 here. ’1344 IPR Final Decision, 16–18. We concluded that a “‘single caching agent’ means ‘one caching agent for the processor, which may be formed from distributed portions.’” Id. at 18. We adopted that construction in our Institution Decision in this case. Inst. Dec. 15.” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“2. Remaining claim terms Independent claims 11 and 16 include different language as to “caching agent.” Claim 11 recites “a caching agent.” Ex. 1001, 8:18. Claim 16 similarly recites “a first caching agent.” Id. at 8:47–48. Neither claims 11 or 16 includes claim 1’s recitation of “distributed portions. The “caching agent” limitations of claims 11 and 16, are not at issue. Accordingly, no construction is necessary.” slip op. at 18
- PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner
“(1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) plaintiff had a full and fair opportunity to litigate the issue in the first action. Pet. Br. 2. Further, Petitioner alleges the ’1344 Final Decision was not appealed by Patent Owner and is therefore a basis for issue preclusion. Id. (citing Power Integrations, Inc. v. Semiconductor Components Indus., LLC, 926 F.3d 1306, 1311–12 (Fed. Cir. 2019)).” slip op. at 19
Patent outcomesUS 8,984,228 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,984,228 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision
Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10
- BurdenNot shown unpatentable
“In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23
Patent outcomesUS 11,959,109 unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,959,109 - Charles River Laboratories, Inc. v. Seikagaku CorporationAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,236,318 - Amazon.Com, Inc. / Amazon.Com Services LLC et al. v. Soundclear Technologies LLCAll claims unpatentablePTAB · Sep 3, 2026 · IPR2025-00673 · APJ Michael R Zecher · IPR · Final written decision
Claims 1–7 are unpatentable as obvious over the combined teachings of the asserted references, including Shin and Aoyama and Shimomura and Iwase.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“1 SoundClear also filed a Contingent Motion to Amend that proposed to replace originally challenged claim 5 of the ’675 patent with proposed substitute claim 8. Paper 21. We, however, granted SoundClear’s request to withdraw its Contingent Motion to Amend and, as a result, the Contingent Motion to Amend will no longer be considered in this proceeding. Paper 30.” slip op. at 2
- Skill levelOther
“2. Level of Skill in the Art In determining whether an invention would have been obvious, we” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMotivation not foundMixed
“combination because (1) configuring Shin’s processor 120 accordingly “would have been trivial, involving straightforward changes to enhance the processor’s approach to simplifying and abbreviating its output”; and (2) this approach was well-known as evidenced by Ha’s disclosure of replacing “team meeting” and “date” with “schedules” based on the user’s environment.6 Id. at 27–28 (first quoting Ex. 1011 ¶ 97, then quoting Ex. 1011 ¶ 98) (citing Ex. 1002 ¶ 102; Ex. 1011, Fig. 7).” slip op. at 33
- Expert testimonyPetitioner expert creditedDecided for petitioner
“4. Dr. Stern’s Testimony is Reliable In its Patent Owner Response, SoundClear contends that “Dr. Stern’s” slip op. at 125
Patent outcomesUS 11,244,675 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,244,675
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.