- Axon Enterprise, Inc. / Dedrone Holdings, Inc. et al. v. Airspace Defense, Inc.Some claims unpatentablePTAB · 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 mixedClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · Graham · NautilusPatents in suitUS 10,514,711 - 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 NautilusPatents in suitUS 10,249,199 - 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 · NautilusPatents in suitUS 10,713,959 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Oct 2, 2026 · PGR2025-00046 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1, 2, 5, and 7–33 are unpatentable because the Petitioner proved lack of written description and lack of enablement; the Board did not find the claims obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”15) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 54
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the Specification allegedly” slip op. at 74
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“E. Ground III - Obviousness 1. Principles of Law The Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398” slip op. at 117
Patent outcomesUS 12,091,692 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,091,692 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Sep 1, 2026 · PGR2025-00017 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1, 2, 6–15, and 17–30 are unpatentable because the challenged claims lack written-description support and are not enabled.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 9
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 53
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶¶ 123–125) do not appear in the written description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. See Ex. 1133 ¶¶ 111–230 (identifying problems with the approaches proposed by Patent Owner’s experts). For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple” slip op. at 53
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“an enzyme has folded,” Dr. Naismith states, “there would need to be additional evidence to justify a conclusion that the folded enzyme is sufficiently stable to retain its folded state” and “a POSA would not believe an enzyme had ‘properly folded’ if it did not maintain activity over a meaningful period or if it formed aggregates within a short period.” Id. ¶ 59.” slip op. at 78
Patent outcomesUS 12,110,520 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,110,520 - Ajinomoto Co., Inc. v. Abtis Co., Ltd.No claims unpatentablePTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision
The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27
Patent outcomesUS 11,896,675 not shown unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 11,896,675 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Jun 24, 2026 · PGR2025-00009 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1, 2, 6–14, and 16–29 are unpatentable based on written description, enablement, and obviousness grounds.
RulingsFinal written decision- Director reviewDirector review, deniedDenied
“Following institution, Patent Owner filed a Director Review Request (Paper 33), and Petitioner filed an Authorized Response (Paper 37), and the then-Acting Director issued a denial of the Director Review Request. Paper 40.” slip op. at 3
- Additional discoveryAdditional discovery, deniedDenied
“(Paper 46, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response (Paper 71, “Pet. Reply”), and Patent Owner filed a Sur-reply (Paper 84, “PO Sur-reply”). Patent Owner filed a motion for additional discovery (Paper 62), Petitioner opposed the Motion for Discovery (Paper 63), and the Board denied the Motion for Discovery (Paper 77).” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“description itself. To the extent the experts disagree on this point, we credit the testimony of Petitioner’s experts over that of Patent Owner’s. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–2012 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’035 patent.” slip op. at 53
Patent outcomesUS 12,123,035 unpatentable§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,123,035 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · Jun 8, 2026 · PGR2025-00004 · APJ Susan L C Mitchell · PGR · Final written decision
Claims 1–4, 7–19, and 22 are unpatentable under § 112(a) for lack of written description and enablement, and under § 103 as obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“1. Petitioner’s Position Petitioner asserts that the “terms used in the claims are either” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“7. Analysis We find the preponderance of the evidence supports a finding that the” slip op. at 59
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the specification allegedly” slip op. at 70
Patent outcomesUS 12,018,298 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,018,298 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · May 18, 2026 · PGR2025-00006 · APJ Cynthia M Hardman · PGR · Final written decision
Claims 1–4 and 8–13 are unpatentable under §112(a) for lack of written description and enablement, and under §103 as obvious over the ’429 patent and Chao.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the understanding of a person of ordinary skill in the art (sometimes referred to 3 US 7,767,429 B2, issued Aug. 3, 2010 (the “’429 patent”) (Ex. 1005). 4 Chao et al., Structure of Human Hyaluronidase-1, a Hyaluronan Hydrolyzing Enzyme Involved in Tumor Growth and Angiogenesis, 46 BIOCHEMISTRY 6911–20 (2007) (Ex. 1006). 5 Patent Owner withdrew the Declaration of Dr. Triggs-Raine. PO Resp. 10 n.6. herein as “POSA”) as of the effective filing date of the challenged claims. Petitioner contends that one of ordinary skill in the art would have had an undergraduate degree, a Ph.D., and post-doctoral experience in scientific fields relevant to study of protein structure and function (e.g., chemistry, biochemistry, biology, biophysics). From training and experience, the person would have been familiar with factors influencing protein structure, folding and activity, production of modified proteins using recombinant DNA techniques, and use of biological assays to characterize protein function, as well with techniques used to analyze protein structure (i.e., sequence searching and alignments, protein modeling software, etc.). Pet. 16.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“5. Evidence and Analysis “The construction of claims is simply a way of elaborating the normally terse claim language in order to understand and explain, but not to change, the scope of the claims.” Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000). We first turn to the intrinsic evidence because “the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). “[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Id. at 1316. [T]he definition in the patent documents controls the claim interpretation. . . . Any other rule would be unfair to competitors who must be able to rely on the patent documents themselves, without consideration of expert opinion that then does not even exist, in ascertaining the scope of a patentee’s right to exclude. Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1578 (Fed. Cir. 1995). a) Intrinsic evidence Our analysis begins with the claims and Specification of the ’262 patent. Claim 1 recites a “modified PH20 polypeptide” that also requires the polypeptide sequence is 95% identical to one of the 35 recited SEQ ID NOs and with at least one of seven amino acids at position 317 of the reference sequence. The ’262 patent states “PH20 refers to a type of hyaluronidase that occurs in sperm and is neutral-active.”7 Ex. 1001, 45:45– 46; cf. id. at 68:33–37. The ’262 patent further explains that “[r]eference to PH20 includes precursor PH20 polypeptides and mature PH20 polypeptides (such as those in which a signal sequence has been removed), truncated forms thereof that have activity, and includes allelic variants and species variants, variants encoded by splice variants, and other variants.” Id. at 45:62–67. The ’262 patent states that “PH20 polypeptides also include those that contain chemical or posttranslational modifications and those that do not contain chemical or posttranslational modifications.” Id. at 46:4–7.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“four species tested, and particularly in a primate model that is physiologically more similar to humans, shows that a POSA would not have understood even unmodified PH20 polypeptides to provide a contraceptive effect in humans and most other species. The data Patent Owner relies upon at most shows an immunocontraceptive effect for unmodified PH20 polypeptides limited to guinea pigs. It does not evidence that a POSA would have understood that the recited modified polypeptides would provide such an effect or otherwise be useful in a contraceptive vaccine. Accordingly, even if the term “modified PH20 polypeptides” were interpreted to include inactive polypeptides that can serve as antigens to provide a contraceptive effect, the preponderance of the evidence does not show that a POSA would have understood the inventors to be in possession of the full scope of the recited polypeptides capable of such use. 7. Analysis We find the preponderance of the evidence supports a finding that the claims fail to comply with the written description requirement. “Every patent must describe an invention. It is part of the quid pro quo of a patent.” Ariad, 598 F.3d at 1345. In determining compliance with the written description requirement for nucleic acid genus claims, the Federal Circuit has identified two extremes. In Capon, claims relying on known nucleotide sequences with known functions were found to satisfy the written description requirement. Capon v. Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005). At the other end, Juno found that for broad claims to a nucleic acid encoding a chimeric T cell receptor with a functional requirement to bind a target, “the written description ‘must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’” Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337 (Fed. Cir. 2021) (quoting Ariad, 598 F.3d at 1349). As explained above, claim 1 requires modified PH20 polypeptides with some hyaluronidase activity. See supra Section II.B. Based on this claim interpretation, we find the evidence in this case closer to Juno than Capon, and that the ’262 patent does not disclose sufficient structural features in the PH20 sequences associated with hyaluronidase or” slip op. at 57
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“6. Analysis Petitioner has the burden to identify how the specification allegedly fails to enable the claims. We address the Wands factors and the parties’ respective arguments and evidence. a) Breadth of Claims and Nature of the Invention Dr. Park states, regarding the breadth of claim 1, that he “calculated the number of distinct polypeptides that exist that meet the specified criteria.” Ex. 1004 ¶ 173. Dr. Park’s table is reproduced below: Dr. Park’s table shows that the “number of distinct peptides is extremely large by all accounts, ranging from 1049 to 1066.” Id. Dr. Hecht agrees, stating the “sequence identity language causes the claims to encompass an immense number of distinct PH20 polypeptides.” Ex. 1003 ¶ 120. To illustrate how large a number like 1066 is, Dr. Hecht states that an “aggregate weight of the smallest set containing one molecule of each of the PH20 mutants would be . . . = 1.37 x 1027 kg. The weight of the Earth is ‘only’ ~ 5.97 x 1024 kg.” Id. ¶ 123. That is, Dr. Hecht states that a complete set of one single molecule of protein that comprises all possible mutations in PH20 as recited in claim 1 would weigh about one thousand times more than the entire mass of planet Earth. See id. In deposition, Dr. Hecht stated “my sense was that the ’262 patent lists a minuscule and highly biased sample of what would be within that fence, in the sense that it only lists single amino acid substitutions while at the same time it’s attempting to claim things that have 20 or more substitutions.” Ex. 2076, 203:6‒12. When asked if a sequence “gives you enough information to tell whether that amino acid sequence is 95 percent identical to SEQ ID NO. 3”, Dr. Hecht answered “Yes, but that’s all it tells you. It doesn’t tell you anything about active, precipitated, aggregated, folded. It doesn’t tell you anything.” Id. at 204:11‒19.” slip op. at 70
Patent outcomesUS 12,152,262 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 12,152,262 - Merck Sharp & Dohme LLC v. Halozyme, Inc.All claims unpatentablePTAB · May 12, 2026 · PGR2025-00003 · APJ Jeffrey N Fredman · PGR · Final written decision
Claims 1–4 and 8–21 are unpatentable for lack of written description and enablement; obviousness over the ’429 patent and Chao was not shown.
RulingsFinal written decision- Skill levelSkill level board ownOther
“VII. LEVEL OF ORDINARY SKILL IN THE ART We consider the grounds of unpatentability in view of the” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“term “modified PH20 polypeptide” in the ’600 patent supports the understanding that some type of activity is required for a polypeptide to be a “modified PH20 polypeptide”, and that the enzymatic activity of hyaluronidase is the most frequently identified activity recited in the definitions section of the ’600 patent. Id. at 48:38–53, 50:9‒17, 51:15‒18, 52:41–47, 55:9–23, 63:37–44, 64:14–19. In contrast, the discussion regarding the potential use of “modified PH20 polypeptides that are inactive” as antigens in contraception vaccines appears only in a non-definitional section of the ’600 patent. Id. at 75:56–58, 72:60–62. Accordingly, it does not modify the definition’s explicit requirement that the claimed “modified PH20 polypeptide” exhibit hyaluronidase activity. Id. at 48:38–53.” slip op. at 19
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“been able to use the data in the Specification to make reasonable predictions about the effect of multiple modifications on hyaluronidase activity, we view this testimony to at most describe a research plan (i.e., a “tool to engage in further modification”14) for finding the recited polypeptides rather than demonstrating the inventors were in possession of the full scope claimed. This is particularly so given the limits of the then-available analytical tools noted above and the fact that the structural connections and three dimensional modeling Patent Owner’s experts attempt to make (see, e.g., Ex. 2070 ¶¶ 129–213; Ex. 2068 ¶ 123) 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. For these reasons, we find that a preponderance of the evidence of record better supports a finding that in the 2011–12 timeframe, it would have been unpredictable to identify which multiple mutants retained hyaluronidase activity, even with the single substitution data provided by the ’600 patent.” slip op. at 51
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“8. Conclusion We find that the balance of evidence supports a finding of undue” slip op. at 101
Patent outcomesUS 11,952,600 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,952,600
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.