• CSPC Megalith Biopharmaceutical Co., Ltd. v. Lepu Biopharma Co. Ltd.All claims unpatentable
  PTAB · Oct 8, 2026 · IPR2025-00685 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–23 are unpatentable as obvious over Wei and Liu, and over Leanna, Wei, and Liu.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, as at institution, we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art.”) (emphasis added, footnotes omitted); but see Indivior Inc. v. Dr. Reddy’s Labys., S.A., 930 F.3d 1325, 1343 (Fed. Cir. 2019) (no clear error in determination that “a person of ordinary skill . . . ‘would be on a team with an engineer or scientist . . . .’”). Consequently, we find the person of ordinary skill in the art was a person who had a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and had at least five years of experience with antibodies and antibody engineering.” slip op. at 11

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

    “Petitioner submits that no term of the Challenged Claims requires construction to resolve the challenges in this Petition.” Pet. 32. We did not construe any terms in our Institution Decision. See DI 6–7. Patent Owner presents no express positions on claim construction. See generally Resp. For the purposes of this Decision, no terms of the challenged claims require construction. Phillips, 415 F.3d at 1312–13. D. slip op. at 12

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “2 G. Wei et al., US 2015/0071923 Al, pub. March 12, 2015. Ex. 1005 (“Wei”). 3 J. Liu, CN 103772504 A, pub. May 7, 2014. Ex. 1007. The Liu reference is published in Simplified Chinese and Petitioner filed a certified English translation, to which we refer herein. See Ex. 1008 (“Liu”). Patent Owner does not contest the accuracy of the translation. See generally Resp. 4 M.R. Leanna & C.L. Becker, WO 2014/152199 A1, pub. Sept. 25, 2014. Ex. 1006 (“Leanna”). 5 Based on our review of each deposition transcript in view of the record as a whole, although each witness appears competent, we are left with the impression that Dr. Bournazos’s testimony is somewhat more credible than Dr. Atanackovic’s. This conclusion is based, inter alia, on each witness’s ability to recall the relevant record and respond to questions on evidentiary and technical issues.” slip op. at 8

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

    “We find that combining Liu’s BA03 antibody with Wei’s ADC platform would have been desirable, predictable, and routine for the ordinarily skilled artisan based on the facts that: (1) cetuximab was a wellknown and well-studied, U.S. regulatory approved, anti-EGFR antibody that would have served as a starting point for new cancer therapies; (2) humanization of therapeutic antibodies is generally desired (and “[e]very antibody can be humanized” and it is advantageous according to Patent Owner’s counsel); (3) BA03 was a well-known humanized version of cetuximab that had several known advantages over cetuximab in addition to lower immunogenicity from humanization; and (4) Wei taught a similar cetuximab-derived antibody, and a humanized cetuximab-derived antibody, each provided in an ADC with a well-known and validated off-the-shelf linker-drug platform, i.e., vc-MMAE, that exhibited a strong anti-tumor response. See, e.g., Ex. 1001, 1:57–2:32, 2:50–3:1, 5:6–53, 18:3–33, 19:26– 29; Ex. 1002 ¶¶ 14, 38, 42–43, 45–53, 56–73, 84–92, 109–117, 178–189, 202–271; Ex. 1005 ¶¶ 9–10, 229–232, 434, 437, 476, 491–506, 664–675, 685, 688, 715, 732, 1103, 1092–1141; Ex. 1008 ¶¶ 3–6, 60, 74, 141–160; Ex. 2027 ¶¶ 7–8, 38, 50, 57 (confirming our understandings regarding the claimed antibody and linker-drug payload); Ex. 2023, 173, 300; see also Resp. 1, 5–6, 23 (Patent Owner made the “choice” to use the prior-art-known BA03 antibody, and known-candidate cytotoxic payload MMAE); Hr’g Tr. 34:20–23, 36:6–38:20, 47:16–50:16 (Patent Owner’s counsel’s argument). When Liu’s BA03 antibody is provided in an ADC with a vc- MMAE or a Mc-vcPAB-MMAE platform (and used as cancer therapy as the references instruct) the invention of the challenged claims is achieved.” slip op. at 52

  Patent outcomesUS 10,792,370 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,792,370
• Axon Enterprise, Inc. / Dedrone Holdings, Inc. et al. v. Airspace Defense, Inc.Some claims unpatentable
  PTAB · Oct 6, 2026 · IPR2025-00629 · APJ Scott C Moore · IPR · Final written decision

  Original claim 12 is not unpatentable; substitute claim 37 is added, while substitute claims 21–28 and 30–36 are denied as obvious.

  RulingsFinal written decision

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

    “F.3d at 1279–80, we begin our analysis with the Specification of the ’711 Patent. The Specification indicates when a UAV (such as the recited “reference aerial vehicle”) navigates autonomously, it flies without manual control, and can, for example, track and fly to a target using information captured onboard the vehicle itself. See Ex. 1001, 3:24–28 (“[I]t may not be desirable to manually control the interceptor aerial vehicle to follow the target UAV. In some embodiments, the interceptor aerial vehicle is able to autonomously track and fly to the target UAV using machine vision based on images captured by a camera of the interceptor aerial vehicle.”). The Specification also indicates that “autonomous” means more than just “automatic flight,” and clarifies that autonomous navigation occurs when a UAV that previously received a target location from an external source subsequently turns and flies itself towards the received location. See, e.g., id. at 4:15–17 (disclosing that the detected location of a target may be provided to an interceptor “to allow it to automatically and autonomously fly toward the direction of the detected location”); 15:64–16:3 (automatic and autonomous navigation occurs when an interceptor’s navigation component and/or flight controller receive the location of a target, and adjust the interceptor “to turn and fly towards the received location . . . based on the received location”); 16:49–60 (“For example, a flight direction and/or speed of an interceptor aerial vehicle are automatically and autonomously adjusted based on a location and size of the target within the captured image. . . . This allows the flight path of the interceptor aerial vehicle to be dynamically adjusted to track and follow a moving target.”).” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “have had reason to combine Beard and Laufer in the manner proposed by Petitioner, the combination would not satisfy the Autonomous Navigation limitation required by claim 12 because Laufer’s autopilot commands are generated by and transmitted from a remote command center (i.e., Laufer’s central controller 115). PO Resp. 15–16. In its Reply, Petitioner does not dispute that Laufer’s autopilot commands are generated by Laufer’s central controller 115, which is remote from the aircraft being controlled. See Reply 13–17. Petitioner asserts, however, that the combination still satisfies the Autonomous Navigation limitation because these autopilot commands are generated without human input. See id. Based on the complete trial record, Patent Owner’s arguments are persuasive. See PO Resp. 15–16; PO Sur-reply 42, 1–6; Ex. 2025 ¶¶ 84–87. The flight of Beard’s UAV 100 under the control of Laufer’s autopilot commands does not satisfy the Autonomous Navigation limitation of claim 12, as we have construed that limitation, because Laufer’s autopilot commands are generated at a location that is remote from UAV 100 (Laufer’s central controller 115.) See, e.g., Ex. 1010 ¶ 40 (“Central controller 115 uses autopilot command module 440 to generate autopilot aircraft commands”), ¶¶ 26, 30 (clarifying that central controller 115 and the controlled interceptor aircraft are separate devices that may communicate through a “wireless connection”), Fig. 4 (depicting “aircraft control commands 475” being generated externally from the depicted “Interceptor Aircraft”); see also Ex. 2025 ¶¶ 95–95. Petitioner never disputes that, in the proposed combination, Laufer’s central controller 115 would remain external to Beard’s UAV 100. See Reply 13–17. Instead, Petitioner relies on its proposed construction of the Autonomous Navigation limitation, which would have encompassed such an arrangement. See id. Our construction of the Autonomous Navigation limitation, which did not adopt Petitioner’s claim construction position, is dispositive of Petitioner’s argument. We thus determine that Petitioner has not shown by a preponderance of the evidence that claim 12 would have been obvious over Beard and Laufer.” slip op. at 15

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

    “the legal requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4, 7–8. For the reasons that follow, we determine that Patent Owner has satisfied this burden. 1. Proposal of a Reasonable Number of Substitute Claims A motion to amend must “propose a reasonable number of substitute claims.” 35 U.S.C. § 316(d)(1)(B); see also 37 C.F.R. § 42.121(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, IPR2018-01129, Paper 15 at 4; see also 37 C.F.R. § 42.121(a)(3). Patent Owner has shown it proposes a reasonable number of substitute claims by proposing a single substitute claim for each of challenged claims 1–4, 8–11, and 13–20. MTA 1–2, Claims App. Petitioner does not argue otherwise. See generally MTA Opp. We determine that Patent Owner meets this requirement. 2. Amendments Respond to a Ground of Unpatentability “A motion to amend may be denied where … [t]he amendment does not respond to a ground of unpatentability involved in the trial.” 37 C.F.R. § 42.121(a)(2)(i). Patent Owner has responded to the grounds of unpatentability involved in this proceeding by amending the claims in response to the Petition’s asserted prior art. See MTA 2, 25, Claims App. Petitioner does not argue otherwise. See generally MTA Opp. We determine that Patent Owner meets this requirement. 3. No Enlargement of the Scope of the Claims An amendment may not seek to enlarge the scope of the claims of the patent. 35 U.S.C. § 316(d)(3); 37 C.F.R. §§ 42.121(b)(1)–(b)(2). Patent Owner asserts that the amendments in the Motion do not enlarge the scope of the claims of the patent because each proposed substitute claim “retains all of the limitations of the corresponding challenged claim, and each proposed independent substitute claim adds further limitations.” See MTA 2, Claims App. Petitioner does not argue otherwise. See generally MTA Opp. We determine that Patent Owner meets this requirement. 4. No Introduction of New Matter An amendment may not introduce new matter. 35 U.S.C. § 316(d)(3);” slip op. at 22

  • 112 supportDecided for patent owner

    “Having considered the evidence and argument cited by both parties, we determine there is sufficient written description support for the disputed portions of limitations [37.e1], [37.e3,] and [37.e4]. The ’452 application discloses selecting between groups of processing schemes (e.g., algorithms) depending on a confidence level, where the groups are, for example: high cost, high robustness algorithms; medium cost, medium robustness algorithms; and low cost, low robustness algorithms. See Ex. 2019 ¶¶ 146–147. These schemes or algorithms may be neural networks. See, e.g., id. ¶ 50 (including neural network as a type of algorithm); see also id. ¶¶ 109–110); see generally MTA Opp 1 (not disputing that schemes may be neural networks). Specifically, the ’452 application describes “algorithms that process video frames of one or more video data streams,” and “produce a prediction of objects within the video f[r]ame, as well as a confidence number that is a measure of quality for that prediction.” Id. ¶ 141. The ’452 application also discloses the concept of switching between neural networks based on confidence levels. In particular, the ’452 application discloses that a “process cycles through the processing schemes to produce a detection of an object,” for example, where “if the confidence number is higher than an activation number, an action is performed to stop or change a running group (i) and select or switch to group (ii).” Id. ¶ 146. More particularly, “a processing scheme from the group of (i) High cost (low refresh rate), high robustness algorithm[s] can select a cheaper processing scheme from the group of (ii) Medium cost, medium robustness algorithms.” Id. The ’452 application additionally discloses that schemes or algorithms (e.g., neural networks) are applied to individual video frames, and that the confidence levels that determine which neural network will be applied in the future are also derived from individual video frames. For example, as discussed above, the ’452 application describes that “[t]he processing schemes produce a prediction of objects within the video f[r]ame, as well as a confidence number that is a measure of quality for that prediction.” Ex. 2019 ¶ 141 (emphases added). The ’452 application also describes selecting and applying an individual neural network, rather than only selecting and applying a group of processing schemes. For example, as highlighted above, the ’452 application describes that “a processing scheme from the” “High” group “can select a cheaper processing scheme from the” “Medium” group. Id. ¶ 146 (emphases added). In our view, these disclosures, read together, would reasonably convey to one skilled in the art that the inventor had possession of the disputed subject matter described above. See Ariad, 598 F.3d at 1351.” slip op. at 24

  Patent outcomesUS 10,514,711 mixed
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · Graham · Nautilus
  Patents in suitUS 10,514,711
• Axon Enterprise, Inc. / Dedrone Holdings, Inc. v. Airspace Defense, Inc.Other
  PTAB · Oct 6, 2026 · IPR2025-00530 · APJ Scott C Moore · IPR · Final written decision

  Original claims 1–9 were canceled; the non-contingent motion to add substitute claims 10–18 was denied for lack of written-description support, and claim 18 was also indefinite.

  RulingsFinal written decision

  • 112 supportMotion to amend, deniedDenied

    “that either the ’303 application or the ’838 provisional contain adequate written description support for the disputed feature of limitation [10.d]. Though the disclosures cited by Patent Owner indicate that a secondary identifier can be used to aid in verification of a UAV, these disclosures also make clear that both first and second identifiers are transmitted by and received from the UAV. See, e.g., Ex. 2002, 4:15–17, 30:24–31:6; Ex. 2003 ¶¶ 14, 66. Patent Owner’s reliance on disclosure characterized as transmitting an identifier from a remote computing system “through the UAV” (Reply 2) is not persuasive. The cited disclosures from the ’303 application and ’838 provisional generally disclose that the identifiers transmitted by a UAV can be “generated remotely,” such as by a “remote computing system.” Ex. 2002, 14:23–15:2; Ex. 2003 ¶ 45. But Patent Owner has not identified disclosure indicating that a remote computing system may transmit an identifier to the identification receiver. In the ’303 application and ’838 provisional, only the UAV (which is part of the discrimination system, and thus not “remote”) actually transmits identifiers to the identification receiver. Patent Owner is correct in its assertion that an “aerial system identifier can be generated on-board the aerial system” or “generated remotely . . . at a remote computing system.” Mot. 7 (citing Ex. 2002, 14:23–15:2; Ex. 2003 ¶ 45). But even if a UAV’s identifier was at some time in the past generated by a remote computing system, the subsequent transmission of that identifier from the UAV to the identification receiver would not satisfy the plain language of limitation [10.d]. The claim language “receive … a second identifier from a computing system that is remote to the discrimination system” requires the receipt of a transmission of the second identifier from a remote computing system. This claim language limits the source of the received transmission (i.e., where the particular transmission is “receive[d] … from”). Thus, the relevant issue is from where was the recited second identifier received. The relevant is not where the second identifier was originally generated.” slip op. at 12

  • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteIndefiniteMixed

    “We determine that the disputed language in limitation [10.d] is not indefinite. There is no recitation in proposed substitute claim 10 that the second identifier is transmitted solely from the identifier transmission system. Thus, the alleged irreconcilable contradiction cited by Petitioner is not recited in the claims. Petitioner’s position appears to rest on the fact that the ’303 application and ’838 provisional do not disclose receiving the second identifier from a remote computing system. See Sur-reply 6 (“To manufacture written description support, [Patent Owner] argues the claim encompasses identifiers routed ‘through the UAV.’”). Though we agree that limitation [10.d] lacks adequate written description support, this defect does not render the claim indefinite because the scope of limitation [10.d] is otherwise reasonably certain based on its plain language. See supra § III.C.4.” slip op. at 18

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artPriority date, deniedDecided for patent owner

    “In contrast, the ’393 provisional never discloses that the described drone defense system may use the identity of a detected drone to develop a particular countermeasure. The disclosed RTSS certainly uses identity information to determine whether a drone is a threat. And if a threat is identified, the RTSS immediately starts “a series of processes … to determine what rule of engagement will be applied on the intruding drone.” Ex. 1006 ¶ 10. The ’393 provisional discloses that the system may select a particular countermeasure based on (i) the particular zone within a protected area within which a drone is located, (ii) “the behavior of the hostile drone,” or (iii) “other instructions.” Id. ¶¶ 9, 10. But the ’393 provisional never discloses that these “other instructions” may include the identity of the drone. The system disclosed in the ’393 provisional uses the identity of a drone to determine whether to activate the countermeasure system. See id. ¶¶ 16–18. But there is no disclosure in the ’393 provisional that the countermeasure system, once activated, uses the identity of the drone to develop the particular countermeasure to be employed. See generally Ex. 1006. Thus, though the Whitmarsh reference itself contains ample written description support for limitation [19e], the earlier-filed ’393 provisional does not. On this record, and having reviewed the ’393 provisional in its entirety, we determine that the ’393 provisional does not “reasonably convey[] to those skilled in the art that the inventor had possession of” the subject matter of limitation [19e] of Whitmarsh’s claim 19 “as of the filing date” of the ’393 provisional. See Ariad, 598 F.3d at 1351.” slip op. at 27

  § 102 anticipation§ 112 disclosurecites Nautilus
  Patents in suitUS 10,249,199
• Axon Enterprise, Inc. / Dedrone Holdings, Inc. v. Airspace Defense, Inc.Other
  PTAB · Oct 6, 2026 · IPR2025-00525 · APJ Scott C Moore · IPR · Final written decision

  Original claim 21 was canceled; the Board denied substitute claim 22 for new matter and held it obvious under §103 based on six combinations.

  RulingsFinal written decision

  • 112 supportMotion to amend, deniedDenied

    “First, Patent Owner has not shown possession of the disputed feature of a “radio communication module [that] is configured to utilize a secure identifier, the secure identifier comprising a specified excitation.” In the ’406 application, the term “excitation” is used exclusively to refer to a light beam signal. See Ex. 2015, 7:8–13, 9:8–10, 23:9.2 The ’406 application discloses that an identification box on an aircraft may include both an RF module and a separate light sensor. See Ex. 2015, 7:3–11. But nowhere does the ’406 application describe receiving a light beam (e.g., an excitation) with the RF module of the identification box (as opposed to the light sensor), so as to provide support for proposed substitute claim 22’s recitation of a “radio communication module” configured to utilize “a secure identifier . . . comprising a specified excitation.” We disagree with Patent Owner that it suffices that one of ordinary skill in the art “would recognize that these disclosures are equally applicable to the RF-only embodiments” (Reply 5). “It is not sufficient for purposes of the written description requirement . . . that the disclosure, when combined with the knowledge in the art, would lead one to speculate as to modifications that the inventor might have envisioned, but failed to disclose.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). On this record, and having reviewed the ’959 Patent, the ’153 provisional, and the ’406 application, we find no evidence in those documents that the named inventor was in possession of the concept of a radio communications module “configured to utilize a secure identifier” where “the secure identifier compris[es] a specified excitation.” Second, setting aside the “radio communication module” in proposed substitute claim 22, Patent Owner also has not shown that the named inventor was in possession of the feature of a “secure identifier comprising a specified excitation.” Patent Owner’s argument that the ’406 application describes a light beam directed to a particular aircraft (see Reply 4–5) is 2 The same is true of the ’153 provisional. See Ex. 2016 ¶¶ 29, 34. unavailing. The fact that the properties of a particular light beam indicate that the light beam is intended for a particular aircraft does not demonstrate that the light beam is a “secure identifier,” as we have construed that term. Patent Owner has not identified any disclosure in the ’406 application of a “secure identifier” comprising a light beam, let alone that such light beam can be utilized by a “radio communication module.” The only references to “secure” identifiers in the ’406 application describe radio frequency signals. See Ex. 2015, 2:4–6, 15:21–17:12.3 Having reviewed the ’959 Patent, the ’153 provisional, and the ’406 application, we find no evidence in those documents that the named inventor was in possession of the concept of a “secure identifier comprising a specified excitation.”” slip op. at 15

  • ScopeDecided for patent owner

    “not impermissibly broaden the scope of the claims of the ’959 Patent. As Patent Owner suggests, there were no limitations in original claim 21 on the type of radio signal the radio communication module could receive, and so it follows that proposed substitute claim 22 does not now encompass receiving a broader set of radio signals. We see no basis for Petitioner’s argument that the past tense verb “received” limited original claim 21 to “signals of a compatible ‘type’ and ‘range.’” Opp. 7. Moreover, the claim language (with the proposed deletion shown double brackets) provides that “the radio communication module is configured to receive a [[received]] radio signal.” Any radio signal that the radio communications module receives would necessarily be a “received” radio signal. Thus, deleting the redundant word “received” does not enlarge the scope of this claim limitation. We also are not persuaded by Petitioner’s suggestion that removing the term “received” broadens original claim 21 by deleting a requirement that the radio signal have already been previously received by the claimed device. See Sur-reply 9. Original claim 21 simply recited, using redundant language, that “the radio communication module is configured to receive a received radio signal.” Ex. 1001, 18:5–7. The most natural reading of this language is that the phrase “received radio signal” is just a description of a radio signal that is received by the recited radio communications module. Petitioner has cited no persuasive evidence that one of ordinary skill in the art would have counterintuitively interpreted this language to impose an additional requirement that the “received radio signal” must have been received twice—a first time by some other component of the device, and a second time by the recited radio communication module. Accordingly, we determine that the proposed amendment does not improperly broaden claim scope.” slip op. at 10

  • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteNot shown unpatentable

    “572 U.S. 898 (2014). See Memorandum: Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021).4 Under Nautilus, a claim is indefinite if fails to “inform those skilled in the art about the scope of the invention with reasonable certainty.” 572 U.S. at 910. We agree with Patent Owner that neither of the identified terms are indefinite. Regarding the term “low-altitude aircraft,” we determine the Specification provides a sufficient basis for understanding the scope and meaning of this term with reasonable certainty. The U.S. Court of Appeals for Federal Circuit has explained that, when a term of degree is recited in a claim, it is necessary “to determine whether the patent’s specification provides some standard for measuring that degree.” See Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984); see also Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350 (Fed. Cir. 2005) (“Some objective standard must be provided in order to allow the public to determine the scope of the claimed invention.”). Here, the Specification describes the related art as including “small UASs (e.g., aircrafts up to 25 pounds flying up to 500 ft of the low altitude airspace).” Ex. 1001, 1:50–52. One of ordinary skill in the art would understand from the Specification that the cited disclosure provides an objective standard for determining the scope of a low-altitude aircraft as one that is designed to fly up to a maximum altitude of about 500 feet.” slip op. at 20

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In our Institution Decision, we adopted Petitioner’s proposal that one of ordinary skill in the art would have had the following qualifications: [E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace, avionics, telecommunications, or electronic device manufacturing industry, or (2) at least four years of industry experience in any of the above industries. Paper 13, 5 (citing Pet. 21). Patent Owner has not disputed this formulation; thus, we adopt it for purposes of this Decision. See Paper 13, 10–11 n. 8.” slip op. at 23

  § 103 obviousness§ 112 disclosurecites Graham · Nautilus
  Patents in suitUS 10,713,959
• Gettattle, Inc. v. Afterwords, Inc.All claims unpatentable
  PTAB · Oct 5, 2026 · IPR2025-00677 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–7, 10, 13, 16, 18, and 19 are unpatentable as anticipated by Douglas and Ganesh; the revised contingent motion to amend is denied.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “record before us, we conclude that Petitioner proves by a preponderance of the evidence that each challenged claim of the ’811 patent is anticipated by Douglas and by Ganesh. Accordingly, we find that claims 1–7, 10, 13, 16, 18, and 19 of the ’811 patent are unpatentable. Moreover, we find that Patent Owner’s Revised Contingent Motion to Amend adds new matter in every proposed substitute claim, and, therefore, the motion is denied.” slip op. at 80

  • 112 supportMotion to amend, deniedDenied

    “Because the RMTA does not meet the foundational statutory and regulatory requirements, we decline to reach Petitioner’s arguments as to the asserted unpatentability of the proposed substitute claims. C. CONCLUSION ON REVISED MOTION TO AMEND Because the RMTA does not meet foundational statutory and regulatory requirements for a motion to amend, it is denied.” slip op. at 80

  Patent outcomesUS 10,430,811 unpatentable
  § 102 anticipationcites Phillips
  Patents in suitUS 10,430,811
• Anthony Inc. v. Controltec, LLCAll claims unpatentable
  PTAB · Sep 30, 2026 · IPR2025-00636 · APJ Barry L Grossman · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious: claims 8–12 over Carter; claims 1–20 over Carter and Bunch; claims 3, 9, 10, and 19 over Carter, Bunch, and King; and claims 2, 11–13, and 17 over Carter, …

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “testimony that we limit the level of ordinary skill to “refrigerated display cases.” Limiting the level of skill to an engineer with experience “working with refrigerated display cases” does not relate to the technology disclosed, and the invention claimed, in the ’847 patent, which is controlling condensation and conserving energy. E.g., Ex. 1001, 2:23–27 (“The invention is proactive in preventing condensation from forming by activating frame/door heaters before the dew point temperature at frame and door surfaces is reached. Power is then cycled off at a set point above dew point to save energy.” (emphases added)). An electrical engineer with a bachelor’s degree and 2 years of experience focused on lighting systems for refrigerated display cases would have “experience working with refrigerated display cases,” and thus meet Patent Owner’s proposed level of skill. Such a person, however, would not be experienced in controlling condensation, dew point sensor positioning, and condensation algorithm design, which is the focus of the disclosed and claimed invention, and which Mr. Pollock states “materially affect performance, energy use, and reliability” in controlling condensation in a refrigerated display case. Ex. 2037 ¶ 10. We also note that Mr. Pollock’s qualifications include a “B.S. in Mechanical Engineering, . . . with focus on thermal and mechanical systems, thermodynamics, and HVAC&R (Heating, Ventilation, Air Conditioning & Refrigeration).” Ex. 2037 ¶ 3. His academic focus is consistent with our determination of the level of ordinary skill. Accordingly, based on the prior art, the sophistication of the disclosed technology in the ’847 patent, finding Mr. Pollock’s testimony on this issue too general, and crediting Dr. Henze’s testimony with substantial probative weight, we adopt Petitioner’s definition of the level of ordinary skill. We” slip op. at 19

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Accordingly, based on the prior art, the sophistication of the disclosed technology in the ’847 patent, finding Mr. Pollock’s testimony on this issue too general, and crediting Dr. Henze’s testimony with substantial probative weight, we adopt Petitioner’s definition of the level of ordinary skill. We more experience will offset less academic training, as did Dr. Henze (Ex. 1003 ¶ 31). Thus, in this proceeding a person of ordinary skill would have a bachelor’s degree in mechanical engineering, electrical engineering, or a comparable field and at least three to five years of professional experience working with heating, ventilating, air conditioning, and refrigeration (HVAC&R) systems, and that more academic training will offset less experience, and more experience will offset less academic training. 2. Dr. Henze Is a Person of Ordinary Skill Patent Owner asserts that Dr. Henze is not a person of ordinary skill and thus is not qualified to provide expert testimony in this proceeding. PO Resp. 18–21 (citing Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F.4th 1369, 1377 (Fed. Cir. 2022). Patent Owner’s argument requires a level of ordinary skill based on “working with refrigerated display cases,” which we have not adopted. PO Resp. 27. Based on the level of skill adopted in the previous section, we determine that Dr. Henze is qualified to provide expert testimony in this proceeding C. Claim Construction We construe each claim “using the same claim construction standard” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notNot reached

    “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Whether the preamble is or is not limiting is not necessary to resolve this controversy because it would not affect the outcome of this case. We also note that it is beyond reasonable dispute that Bunch, applied with Carter against all the challenged claims, discloses display cases with glass doors. Ex. 1006, 1:14–16. Bunch also discloses that, in the display cases, “[t]o combat condensation and frost, heaters are installed in refrigerator doors and frames, which raise the temperature of the door or frame sufficiently to eliminate condensation.” Id. at 1:24–26. slip op. at 22

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “A reference qualifies as prior art for an obviousness determination only when it is analogous to the claimed invention. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (“References within the statutory terms of 35 U.S.C. § 102 qualify as prior art for an obviousness determination only when analogous to the claimed invention.” (citing In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992))). The Federal Circuit has laid out two separate tests to determine whether a reference is analogous art to the claimed invention, i.e., whether reference. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). These two tests are: “(1) whether the art is from the same field of [the inventor’s] endeavor” and “(2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id.; see also Netflix, Inc. v. DivX, LLC, 80 F.4th 1352, 1359 (Fed. Cir. 2023) (“Importantly, ‘the scope of any field of endeavor will vary with the factual description of each invention.’ Unlike the reasonable-pertinence test, the field-of-endeavor test does not look to the problem that the patent purports to address. It is enough that the prior art reference falls within the relevant field of endeavor of the patent-in-suit.”) (citations omitted); Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001 (Fed. Cir. 2016) (“To determine if art is analogous, we look to ‘the purposes of both the invention and the prior art.’ If a reference disclosure and the claimed invention have a same purpose, the reference relates to the same problem, which supports an obviousness rejection.” (citations omitted)); see also Nielsen Co. (US), LLC v. TVision Insights, Inc., 186 F.4th 1363, 1369–1370 (Fed. Cir. 2026) (providing a comprehensive summary and analysis of the applicable law concerning analogous art)” slip op. at 37

  Patent outcomesUS 7,421,847 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,421,847
• Evenflo Company, Inc. v. Baby Jogger II, LLCAll claims unpatentable
  PTAB · Sep 29, 2026 · IPR2025-01122 · APJ Carl M Defranco · IPR · Final written decision

  Claims 1–16 are unpatentable as obvious over Liao or Liao and Cheng; Rolicki is not prior art, and the challenge over Offord ’341 and Offord ’797 fails.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A. Level of Ordinary Skill in the Art Baby Jogger does not dispute Evenflo’s definition of the level of ordinary skill in the art, which is that a person of ordinary skill in the art (hereinafter, “one skilled in the art”) would have had “a bachelor’s degree in a relevant field (e.g., mechanical engineering or industrial design) and at least two years of product design experience and/or industry experience with juvenile products” and that “[m]ore education can replace product design experience, and vice versa.” Pet 8 (citing Ex. 1001 ¶¶ 31–33); PO Resp. generally. We apply that definition here, as it accords with the problems addressed in the prior art and the specification of the ’682 patent.” slip op. at 7

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

    “At the outset, we note that the claim language requires only that “the first seat and the second seat” be arranged in an inline descending configuration, not that the seat’s mounting points or other physical connections be so arranged. Ex. 1010, 17:31–33. Baby Jogger improperly reads “seats” out of the claim and substitutes the seat’s “mounting points” on the frame. A proper reading of the claim language focuses on what happens when both seats are connected to the frame, not where they are so connected. In other words, “when connected to the frame” simply emphasizes that both seats must be connected to the frame to form the inline descending configuration, as opposed to the single stroller embodiment of Figure 1, where there cannot be an inline descending configuration because only one seat is connected to the frame and the other seat is removed, i.e., not connected to the frame. That reading is supported by the specification of the ’682 patent,” slip op. at 9

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “We find that testimony persuasive, for it shows what one skilled in the art would have recognized the 2008 Provisional as necessarily disclosing. The relevant inquiry is whether the disclosure of the prior application “convey[s] with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention.” PowerOasis, 522 F.3d at 1306 (emphasis in original; citation omitted). “While a prior application need not contain precisely the same words as are found in the asserted claims, . . . the prior application must indicate to a person skilled in the art that the inventor was ‘in possession’ of the invention as later claimed.” Id. In other words, “to satisfy the written description requirement, ‘the missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.’”7 Id. (quoting Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998) (emphasis added). “This requires that the written description actually or inherently disclose the claim element.” Id. at 1306–07. Moreover, a drawing may supply written description for the arrangement it depicts even though the text describes that arrangement in different terms. See Cooper Cameron Corp. v. Kvaerner Oilfield Prods., Inc., 291 F.3d 1317, 1319–23 (Fed. Cir. 2002).” slip op. at 16

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Instead, Evenflo’s argument rests on isolating the statement—“A similar sub-frame arrangement is disclosed in [Offord ’797]”—from the remainder of the passage in which that statement appears in order to arrive at a reason to incorporate the reversibility teaching of Offord ’797. However, when that statement is read in the context of the full passage in which it appears, nowhere does that passage suggest reversibility as the reason for referencing Offord ’797. More accurately, it suggests a different reason that relates to a curved lug 108 by which sub-frame 100 rests on the stroller’s main frame 4 to carry the weight of the stroller’s two occupants— When the interface components 100 are attached to the frame assembly 4 they form a sub-frame of the frame assembly 4, and when the child-carrying units are mounted thereon, one behind the other, they are in a compact echelon formation, one of the connector sockets 106 of each component 100 being at a higher level in relation to the ground than the other connector sockets 106. The higher connector socket 106 and further connecting leg 102 are both connected to the respective opposite ends of an upper mounting piece 107. In addition, on the inner side of the lower connector sockets 106 there is a downwardly curved lug 108 which serves to rest upon a part of the basket frame 44, such that the weight of two infants is fully supported by the frame assembly 4. A similar sub-frame arrangement is disclosed in [Offord ’797]. Ex. 1051, 9:23–36 (emphasis added). That passage shows that, rather than reversibility of the sub-frame, the reference to Offord ’797 is more aptly directing the reader to the arrangement and details of a similarly curved lug structure in the stroller sub-frame of Offord ’797. Indeed, Figures 5 and 6 of Offord ’797, reproduced below, disclose just such a curved lug in the context of “corner pieces 20” having “channel 21.” Ex. 1054, 4:10–23.” slip op. at 53

  Patent outcomesUS 11,731,682 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 11,731,682
• Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco Limited And Willow Innovations, Inc.All claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,806,454
• 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

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.