• 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
• Posco Co., Ltd. v. ArcelormittalAll claims unpatentable
  PTAB · Jul 16, 2026 · IPR2025-00371 · APJ Brian D Range · IPR · Final written decision

  Claims 1–25 are unpatentable as obvious under § 103 over the asserted combinations of Takagi, Cornette, Suehiro, GMW14400, Laurent, and Vaissiere.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art (POSITA) “would have had an undergraduate degree in materials science, manufacturing engineering, mechanical engineering, or equivalent knowledge, training, or experience, with two years of experience working in metallurgy.” Pet. 6 (citing Ex. 1003 ¶ 15). Patent Owner does not challenge Petitioner’s definition of a POSITA for this proceeding. PO Resp. 8. Because the parties agree and because Petitioner’s proposal is reasonable and consistent with the ’227 patent specification and the prior art, we adopt Petitioner’s proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “1. superficial layer The only independent claim at issue, claim 1, recites a “Superficial layer.” Ex. 1001, 15:6. Patent Owner argues that, based on plain and ordinary meaning, the term “superficial layer” refers to a “surface layer” or “top layer.” PO Resp. 8–9. Petitioner does not dispute this construction. See Pet. Reply 21–22 (arguing that the relevant layer of the Suehiro reference is a superficial layer because it is outermost and present at the surface). Because the parties are in agreement and because that agreement is consistent with plain language, claim language, and the ’227 specification, we construe “superficial layer” as referring to a surface layer or top layer.” slip op. at 10

  • Claim Construction › Extrinsic evidence (dictionaries, experts)Term construed petitioner constructionDecided for petitioner

    “defined stoichiometry” (Ex. 2037, 527) but the word may also be a “generic term for phases . . . which may have a narrow or extended compositional stability range” (id.). The first glossary meaning is consistent with Patent Owner’s position. The second, broader, glossary meaning is consistent with Petitioner’s position. Some of the extrinsic sources before us support the broad definition, and some support the narrow definition. See PO Sur-Reply 3–4 (arguing that Dr. Miles admitted that various treatises distinguish intermetallic compounds from alloys and solid solutions). Thus, neither Dr. Miles or Dr. Raabe is “wrong scientifically” in how they use the term “intermetallic” in this proceeding. Id. at 2 (noting that Dr. Miles agreed that Dr. Raabe’s construction is not wrong scientifically). As explained below, however, only one of these meanings is appropriate here. To decide which possible meaning applies to the ’227 patent, we focus on the patent claims and specification. Claim 1 indicates that the intermetallic layer has a “mean composition” (emphasis added). Ex. 1001, 15:1–10. This indicates, albeit weakly, that iron composition across the layer may vary rather than having ordered stoichiometry—consistent with Petitioner’s position. The specification also indicates that “intermetallic alloying” is a possibility—again, consistent with Petitioner’s position. Ex. 1001, 2:47–50. Meanwhile, nothing in the ’227 specification explicitly (or implicitly) suggests that “intermetallic layer” must be limited to elements atomically joined with defined stoichiometry in an ordered crystal structure. We also find that Dr. Miles’s testimony regarding the meaning of “intermetallic” is more credible than Dr. Rabbe’s testimony. Dr. Rabbe, in deposition, stated that Figure 2 of the challenged patent “does not show a layer that meets [his] construction of intermetallic.” Ex. 1078, 129:21–24. The ’227 patent, however, states that Figure 2 includes an “Al-rich Intermetallic layer.” Ex. 1001, Fig. 2, 3:60–64 (“FIG 2. Illustrates a coating … which does not correspond to the invention. This succession of layers (interdiffusion layer and intermetallic layer) yields inferior results in resistance spot welding.”). Also, Dr. Raabe previously referred to a layer of Takagi as having “intermetallic phase layering and structure.” Pet. Reply 4 (citing Ex. 1076 ¶ 166; Ex ¶ 1075, 17) (emphasis omitted). Thus, Dr. Raabe’s construction of “intermetallic” for this proceeding does not fully account for the ’227 patent usage of the word “intermetallic” and does not fully account for Dr. Raabe’s prior usage of the word “intermetallic.” Patent Owner argues that Petitioner’s construction “erases the meaningful distinction” between the claimed layers. PO Resp. 11. Patent Owner further argues that Petitioner’s construction renders the word “intermetallic” superfluous because allowing the intermetallic layer to be “merely a multi-element alloy erases the meaningful distinction among these layers.” Id. We disagree. The word intermetallic serves to require that the layer be composed of two or more metals or a metal and a metalloid. The word intermetallic also serves as a label to differentiate each of the four claimed layers. For example, in claim 1, the word “intermetallic” is used much like the words “interdiffusion” and “intermediate” to give each of the four layers (each having differently mean compositions) different labels.” slip op. at 16

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “Because IHS was a company that created an online database with the purpose of providing (selling) standards including General Motors standards to the public, we determine that a person of ordinary skill in the art would have known to look to this database and would have been able to find GMW14400. Patent Owner presents no evidence to the contrary. Because a preponderance of the evidence supports Petitioner, we determine Petitioner establishes GMW14400 is qualifies as prior art.” slip op. at 21

  Patent outcomesUS 11,326,227 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,326,227
• Posco Co., Ltd. v. ArcelormittalAll claims unpatentable
  PTAB · Jul 16, 2026 · IPR2025-00370 · APJ Brian D Range · IPR · Final written decision

  Claims 1–30 are unpatentable as obvious under § 103 over the asserted combinations of prior art.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art (POSITA) “would have had an undergraduate degree in materials science, manufacturing engineering, mechanical engineering, or equivalent knowledge, training, or experience, with two years of experience working in metallurgy.” Pet. 6 (citing Ex. 1003 ¶¶ 13–16). Patent Owner does not challenge Petitioner’s definition of a POSITA for this proceeding. PO Resp. 8. Because the parties agree and because Petitioner’s proposal is reasonable and consistent with the ’602 patent specification and the prior art, we adopt Petitioner’s proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8

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

    “1. superficial layer All independent claims at issue, claims 1, 21, and 24, recite a “superficial layer.” Ex. 1001, 15:11, 16:60, 17:21. Patent Owner argues that, based on plain and ordinary meaning, the term “superficial layer” refers to a “surface layer” or “top layer.” PO Resp. 8–9. Petitioner does not dispute this construction. See Pet. Reply 21–22 (arguing that the relevant layer of the Suehiro reference is a superficial layer because it is outermost and present at the surface). Because the parties are in agreement and because that agreement is consistent with plain language, claim language, and the ’602 specification, we construe “superficial layer” as referring to a surface layer or top layer.” slip op. at 10

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

    “defined stoichiometry” (Ex. 2037, 527) but the word may also be a “generic term for phases . . . which may have a narrow or extended compositional stability range” (id.). The first glossary meaning is consistent with Patent Owner’s position. The second, broader, glossary meaning is consistent with Petitioner’s position. Some of the sources before us support the broad definition, and some support the narrow definition. See PO Sur-Reply 3–4 (arguing that Dr. Miles admitted that various treatises distinguish intermetallic compounds from alloys and solid solutions) Thus, neither Dr. Miles or Dr. Raabe is “wrong scientifically” in how they use the term “intermetallic” in this proceeding. Id. at 2 (noting that Dr. Miles agreed that Dr. Raabe’s construction is not wrong scientifically). As explained below, however, only one of these meanings is appropriate here. To decide which possible meaning applies to the ’602 patent, we focus on the patent claims and specification. The claims indicate that the intermetallic layer has a “mean iron composition” (emphasis added). Ex. 1001, 15:6–10. This indicates, albeit weakly, that the iron composition across the layer may vary rather than having ordered stoichiometry— consistent with Petitioner’s position. The specification also indicates that “intermetallic alloying” is a possibility—again, consistent with Petitioner’s position. Id. at 2:50–54. Meanwhile, nothing in the ’602 specification explicitly (or implicitly) suggests that “intermetallic layer” must be limited to elements atomically joined with defined stoichiometry in an ordered crystal structure. We also find that Dr. Miles’s testimony regarding the meaning of “intermetallic” is more credible than Dr. Raabe’s testimony. Dr. Raabe, in deposition, stated that Figure 2 of the challenged patent “does not show a layer that meets [his] construction of intermetallic.” Ex. 1078, 129:21–24. The ’602 patent, however, states that Figure 2 includes an “Al-rich Intermetallic layer.” Ex. 1001, Fig. 2, 3:57–61 (“FIG 2. Illustrates a coating . . . which does not correspond to the invention. This succession of layers (interdiffusion layer and intermetallic layer) yields inferior results in resistance spot welding.”). Also, Dr. Raabe previously referred to a layer of Takagi as having “intermetallic phase layering and structure.” Pet. Reply 4 (citing Ex. 1076, 166; Ex. 1075, 17) (emphasis omitted). Thus, Dr. Raabe’s definition of “intermetallic” does not fully account for the ’602 patent usage of the word “intermetallic” and does not fully account for Dr. Raabe’s prior usage of the word “intermetallic.” Patent Owner argues that Petitioner’s construction “erases the meaningful distinction” between the claimed layers. PO Resp. 11. Patent Owner further argues that Petitioner’s construction renders the word “intermetallic” superfluous because allowing the intermetallic layer to be “merely a multi-element alloy erases the meaningful distinction among these layers.” Id. We disagree. The word intermetallic serves to require that the layer be composed of two or more metals or a metal and a metalloid. The word intermetallic also serves as a label to differentiate each of the four claimed layers. For example, in claim 1, the word “intermetallic” is used much like the words “interdiffusion” and “intermediate” to give each of the four layers (each having differently defined mean iron compositions) different labels.” slip op. at 16

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

    “have had reason to combine teachings of Takagi and Cornette with a reasonable expectation of success. Pet. 11–20 (citing, e.g., Ex. 1003 ¶¶ 28– 42; Ex. 1016 ¶ 35; Ex. 1014, 9; Ex. 1025, 5:17–20; Ex. 1026, 7; Ex. 1034 ¶ 13). In particular, Petitioner argues that Takagi discloses a pre-coating thickness of 10–20 µm but does not explicitly disclose a post hot-stamping coating thickness corresponding to the pre-coating thickness. Pet. 11. Cornette teaches that the hot-stamping thickness causes coating expansion from 25 µm to about 40 µm, an increase of 60%. Id. (citations omitted). Petitioner and Dr. Miles reason that, when hot stamping Takagi’s product, the thickness would be 32 µm. Id. (citing Ex. 1003 ¶ 32); see also Pet. Reply 20–21. Thus, Patent Owner argues that Cornette evidences Takagi’s finally coating thickness without requiring modification of Takagi. Petitioner further argues that Takagi and Cornette teach that post hot- stamping thickness could be varied and optimized as a result effective variable. Id. at 12–13; see also Pet. Reply 17–18. Cornette teaches, for example, that “[t]he average [pre-coating] layer thickness showing the best compromise between corrosion protection and weldability is 25 µm” and links this pre-coating thickness to a final thickness of “about 40 µm at the steel surface.” Ex. 1014, 9. Petitioner also argues that it would have been obvious to fill in other details of Takagi including, for example, selecting USIBOR 1500 steel, based on the teachings of Cornette. Pet. 14. Patent Owner argues that there is no reason to combine Takagi with the teachings of Cornette. PO Resp. 26. Patent Owner makes seven related arguments. Patent Owner first argues that the Petitioner’s position is speculative and lacks basis. Id. at 26–27. We disagree. Cornette evidences a final coating thickness for Takagi, and the references also suggest that final coating thickness is result effective. Second, Patent Owner argues that there would have been no incentive to seek a motivation to seek a thicker coating post-hot stamping. Id. at 28– 35. This argument does not undermine Petitioner’s position that Takagi, by itself, would have reached a thicker coating after stamping as evidenced by Cornette. Pet. 11–12. Petitioner takes the position, with evidence, that practice of Takagi alone would reach the recited thickness. No motivation to modify Takagi is required under this position.” slip op. at 25

  Patent outcomesUS 10,961,602 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,961,602
• Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentable
  PTAB · Mar 16, 2026 · IPR2024-01378 · APJ John G New · IPR · Final written decision

  Claims 1–10 are unpatentable as anticipated by Svihra or obvious over the asserted combinations; the cited non-patent references qualify as printed publications.

  RulingsFinal written decision

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

    “Legal Standards Anticipation A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). However, a reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). The “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009).” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “(citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). Of particular relevance to the case presently before us is the VidStream court’s holding that “[w]hen there is an established publisher there is a presumption of public accessibility as of the publication date.” VidStream, 981 F.3d at 1065. Hulu addressed, inter alia, whether certain asserted references were shown to be publicly available and could be considered as prior art. IPR2018-01039, Paper 29 at 8. In Hulu, the Board held that, although testimonial evidence is one way to prove public accessibility, there are also various indicia of publication and other evidence that may be considered as a totality of the evidence to determine if an asserted reference was publicly accessible and prior art. Id. at 18. Facts to be considered in analyzing the issue, other than testimonial evidence, include, for example, whether there is an established publisher, a copyright date/notice, other publication-related dates (impression, printing, etc.), an ISBN number, citations to the reference before (and to a lesser degree, after) the priority date at issue corroborating its availability and/or that the publisher was established. Id. at 19–20 (see Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021)). Here, we find the totality of evidence supports the conclusion that Petitioner has made a sufficient showing that Svihra and Amarenco (as well as the other identified non-patent references) were printed publications, and publicly accessible, prior to the ’477 patent’s priority date. We note at the outset that Patent Owner does not allege that any contested reference is fabricated, or a counterfeit document, but only that Petitioner has not set forth sufficient facts establishing that such references were published and available. Resp. 4. Svihra bears sufficient indicia of publication to conclude it was a printed publication and publicly accessible as of 2002. Ex. 1004. First, it appears on its face to be a legitimate scientific journal article; it indicates it was included at pages 480–83 in volume 103 (No. 12) of Bratisl Lek Listy, the Bratislava Medical Journal, which was established in 1921. The article identifies that it was received for publication on May 30, 2002, and accepted for publication on December 9, 2002; and multiple means of contact for the author and publisher are provided. Id. at 480, 483. Each of these indicia supports the contention that Svihra was published and publicly available in 2002. There is no direct evidence that Svihra was publicly accessed as of this date, but the article is cited as a reference in each of Exhibits 1085–1087, which further supports that Svihra was, generally, publicly available to interested individuals of ordinary skill in the art, which further corroborates that it was a published and publicly accessible publication. Having an established publisher also creates a presumption of publication for Svihra, which has not been rebutted by Patent Owner. VidStream, 981 F.3d at 1065.” slip op. at 22

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

    “Petitioner also explains why a person of ordinary skill would have been motivated to combine the cited references, again citing specific disclosures from the references, and the supporting testimony of Dr. Wingeier. See Pet. at 27–28. Based on our review of Petitioner’s arguments and the evidence of record, we determine that Petitioner has established, by a preponderance of the evidence, that the cited references teach or suggest all of the limitations of challenged claim 1, and that Petitioner has established why a person of ordinary skill would have been motivated to combine the references, as proposed, with a reasonable expectation of success, for the reasons advocated by Petitioner with respect to Ground 2.” slip op. at 14

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 14 (citing Ex. 1003 ¶ 21). Patent Owner does not dispute Petitioner’s proposal. See generally Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and the level of skill in the prior art, we adopt Petitioner’s proposed definition and additionally use the term “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 10

  Patent outcomesUS 9,002,477 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 9,002,477
• Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentable
  PTAB · Mar 16, 2026 · IPR2024-01375 · APJ John G New · IPR · Final written decision

  Claims 1–13 are unpatentable as obvious under § 103 over Svihra, Mann, and Ponsford, and independently over Amarenco, Mann, and Ponsford.

  RulingsFinal written decision

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

    “Ex. 1001, claim 1. In other words, to effectuate “direct” stimulation of the PTN nerve branch, a practitioner of the ’742 patent must: (1) non-invasively position an electrical stimulator relative to a portion of a patient’s body, such that a branch of a posterior tibial nerve within the first portion of the body is directly targeted by the electrical stimulator; (2) passing a current through the electrical stimulator; and (3) delivering an electrical stimulus from the electrical stimulator to the branch of the posterior tibial nerve such that the branch directly receives the electrical stimulation. Merely “placing electrodes over branches of the PTN” cannot be said, in and of itself, to “directly” target and stimulate the branches, as Petitioner argues.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “of filing “would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 21 (citing Ex. 1003 ¶¶ 20–21). Patent Owner does not dispute Petitioner’s proposal. See generally Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, we adopt this definition, and also use the term “skilled artisan” to refer to persons with such skill at the time the invention was filed.” slip op. at 13

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

    “the evidence of record, that a person of ordinary skill in the art would have found it obvious to modify the teachings of Svihra by non-invasively stimulating a nerve branch of the PTN, e.g., the medial or lateral plantar nerves, as taught by Ponsford, to treat OAB/urinary incontinence. A skilled artisan would have understood that the fibers of a given branch of the PTN necessarily constitute a subset of the PTN fibers, stimulation of which is known to be effective in the treatment of OAB/urinary incontinence. See Ex. 1004, 480–481. Just as it was known in the art that stimulation of the much larger sacral nerve, of which the fibers of the PTN form a part, could have beneficial effects in the treatment of incontinence, and that stimulation of the PTN itself could have a similar effect (see Ex. 1084, col. 12, ll. 33–52), so, a skilled artisan could reason, might electrical stimulation of a branch of the PTN exert a similar effect. We also agree that a person of ordinary skill in the art would have been motivated to stimulate a smaller nerve branch of the PTN, rather than the entire PTN itself, so as to minimize undesirable side effects of stimulating the entire PTN, i.e., the recruitment of downstream muscular contraction, as taught by Mann. With respect as to whether a person of ordinary skill in the art would have had a reasonable expectation of success in the treatment of OAB/incontinence via stimulation of a branch of the PTN, rather than the entire PTN itself, we agree with Petitioner that a person of ordinary skill in the art, would understand from Mann that electrical stimulation of the larger, more central sacral nerve could be employed to treat OAB/urinary incontinence, and that a subset of those PTN fibers could be electrically stimulated to achieve a similar effect. See Ex. 1084, col. 12, ll. 33–52. Such a skilled artisan could similarly reason that a subset of those PTN fibers, i.e., a branch of the PTN, particularly major branches such as the plantar nerves, could also be similarly electrically stimulated to treat OAB/urinary incontinence. Although success in such an experiment would not be guaranteed, “only a reasonable expectation of success, not absolute predictability, is necessary for a conclusion of obviousness.” In re Longi, 759 F.2d 887, 897 (Fed. Cir. 1985).” slip op. at 46

  Patent outcomesUS 11,224,742 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,224,742
• Nxtgen Toys, LLC v. Zipstring, LLCAll claims unpatentable
  PTAB · Feb 20, 2026 · IPR2024-01213 · APJ Richard H Marschall · IPR · Final written decision

  Claims 1–4, 12, and 15–17 are unpatentable; substitute claim 27 is allowed, while substitute claims 21–26 and 28 are denied as obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person having ordinary skill in the art at the time of the invention “was typically a person with a bachelor’s degree in mechanical engineering, aerospace engineering, physics, or other science or 6 Patent Owner does not rely on any objective indicia of nonobviousness in this proceeding. engineering based degree that [was] familiar with general principles of mechanics and aerodynamics with at least two years of experience in product design and development in the field of toys or other amusement type devices.” Pet. 32 (citing Ex. 1002 ¶¶ 2–6, 22–26). Patent Owner states that it submitted the following proposal for a POSITA in the related district court litigation: “[a POSITA] would have had at least a B.S. degree in Mechanical Engineering, Electrical Engineering, Aerospace Engineering, Industrial Design, Product Design, or similar field, with at least two years industry experience in one of these fields, and such POSITA would have been familiar with general principles of mechanics, fluid mechanics and aerodynamics.” PO Resp. 4–5. We note that the parties’ proposals overlap considerably, and neither party argues the inadequacy of the other party’s proposal or that any patentability issue in this case turns on the resolution of this issue. We find Petitioner’s definition consistent with the problems and solutions disclosed in the ’774 patent and prior art of record, and adopt it as our own. See, e.g., GPAC, 57 F.3d at 1579 (approving the determination of the level of ordinary skill in the art by appeal to the references of record). We would arrive at the same findings and conclusions in this Decision if we adopted Patent Owner’s proposal.” slip op. at 7

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

    “Id. at 1312–13. Only terms in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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)). Petitioner contends that no “term requires construction to resolve the invalidity grounds presented in this Petition since the prior art renders claims 1–4, 12, and 15–17 unpatentable under any reasonable interpretation of the claims.” Pet. 7. Patent Owner argues that it “does not believe express claim constructions are necessary during this proceeding because the claims can readily be given their ordinary and customary meaning in the context of the patent at the time it was filed.” PO Resp. 5. Based on the parties’ positions and our view of the record, we need not expressly construe any claim limitations to resolve the issues in this Decision. To the extent that any implicit claim construction issues relate to the issues raised by the parties, we address them in the context of the parties’ patentability arguments below.” slip op. at 9

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

    “string, and that adding Scorch’s slot removes this arguably inconvenient process by allowing insertion and removal of a string without removing and reinstalling any aspects of the housing. See Pet 85–86 (citing Ex. 1002 ¶¶ 174–175; Ex. 1007, 3:30–3:53, 6:03; Ex. 1008, 3:46–4:45); Pet. Reply 18–20 (citing in part Ex. 2002 ¶ 187 (Dr. Janét’s testimony that Wagner’s removal and reinstallation of a cover “may be viewed as an inconvenient process”)). Making insertion and removal of the string easier and quicker provides a notable advantage over Wagner’s existing device. See id. Scorch itself supports this argument and the related expert testimony because it discusses insertion and removal of strings and stated that the slot allows a user to “swap them out really quick.” Ex. 1007, 3:30–53. Petitioner also persuasively argues that a POSITA would know how to add the slot while maintaining the proper operation of the device, such as allowing insertion and removal of the string and avoiding inadvertent exiting of the string from the device. See Pet. 86–87 (citing Ex. 1002 ¶¶ 175–176; Ex. 1007, 4:00–30, Ex. 1008, 2:49–52); Pet. Reply 19, 21 (citing Ex. 1002 ¶¶ 174–176). We find Petitioner’s arguments and reasoning in support of adding Scorch’s slot to Wagner’s housing straightforward and persuasive. Patent Owner’s arguments against the combination do not directly refute Petitioner’s reasoning or cast doubt on Scorch’s statement that its slot enables “quick” insertion and removal of a string—quicker than Wagner’s method that requires removal and replacement of a cover on its housing. See PO Resp. 16–22; PO Sur-reply 14–20; Ex. 2002 ¶ 187 (acknowledging inconvenience of Wagner’s existing process for insertion and removal of a string). Patent Owner suggests that Petitioner’s proposed combination fails to take into consideration certain drawbacks such as the risk of inadvertent string exit from the housing or slot, but Petitioner expressly addresses such concerns in the Petition. See PO Resp. 18 (stating that Scorch’s slotted funnel may allow the string to “shoot out the slot” and that Scorch addresses this by adding “a bent wire” to “prevent the string from coming out the side”); PO Sur-reply 16–17; Pet. 86–87 (arguing that Wagner’s flanges would help to trap the string in place, but if not, Scorch’s additional structures could be used to restring the string and “to further reduce the risk of a string inadvertently exiting” the device). We agree with Petitioner that a POSITA would understand how to incorporate Scorch’s slot without causing inadvertent removal of the string—using structures already present in Wagner and Scorch—and the need to add such unclaimed structurers does not teach away from the combination as Patent Owner suggests. See Pet. 86–87; PO Resp. 22. We also agree with Petitioner that a POSITA would understand how to make minor modifications, if necessary, to allow insertion and removal of the string around Wagner’s flanges. See Pet. Reply 21 (citing Ex. 1002 ¶¶ 174–176).” slip op. at 26

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “refute Petitioner’s reasoning or cast doubt on Scorch’s statement that its slot enables “quick” insertion and removal of a string—quicker than Wagner’s method that requires removal and replacement of a cover on its housing. See PO Resp. 16–22; PO Sur-reply 14–20; Ex. 2002 ¶ 187 (acknowledging inconvenience of Wagner’s existing process for insertion and removal of a string). Patent Owner suggests that Petitioner’s proposed combination fails to take into consideration certain drawbacks such as the risk of inadvertent string exit from the housing or slot, but Petitioner expressly addresses such concerns in the Petition. See PO Resp. 18 (stating that Scorch’s slotted funnel may allow the string to “shoot out the slot” and that Scorch addresses this by adding “a bent wire” to “prevent the string from coming out the side”); PO Sur-reply 16–17; Pet. 86–87 (arguing that Wagner’s flanges would help to trap the string in place, but if not, Scorch’s additional structures could be used to restring the string and “to further reduce the risk of a string inadvertently exiting” the device). We agree with Petitioner that a POSITA would understand how to incorporate Scorch’s slot without causing inadvertent removal of the string—using structures already present in Wagner and Scorch—and the need to add such unclaimed structurers does not teach away from the combination as Patent Owner suggests. See Pet. 86–87; PO Resp. 22. We also agree with Petitioner that a POSITA would understand how to make minor modifications, if necessary, to allow insertion and removal of the string around Wagner’s flanges. See Pet. Reply 21 (citing Ex. 1002 ¶¶ 174–176). At best, Patent Owner’s arguments on this issue establish potential drawbacks in Petitioner’s proposed combination, but drawbacks alone do not defeat Petitioner’s obviousness rationale that includes readily apparent benefits. See Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit . . . should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another.”); Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine “). In addition, even if Patent Owner were correct that Wagner’s existing design works as well as Petitioner’s proposed combination, given all of the tradeoffs involved, that would not fatally undermine Petitioner’s showing. In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (obviousness does not require that the proposed combination “is the preferred, or most desirable, combination”). On this record, Petitioner’s (and Scorch’s) stated advantages that are achieved when adding Scorch’s slot to Wagner’s housing adequately support Petitioner’s motivation to combine rationale.” slip op. at 26

  Patent outcomesUS 11,674,774 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Nautilus
  Patents in suitUS 11,674,774
• Avation Medical, Inc. v. Emkinetics, Inc.All claims unpatentable
  PTAB · Jan 7, 2026 · PGR2024-00043 · APJ Ryan H Flax · PGR · Final written decision

  Claims 1–39 are unpatentable under Grounds 1–10; Petitioner did not prove lack of enablement under Ground 11, and Patent Owner’s motion to exclude was denied.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “REAL PARTIES-IN-INTEREST Petitioner identifies Avation Medical, Inc. as the real party-in-interest. Pet. x. Patent Owner identifies EMKinetics, Inc. as the real party-in-interest. Paper 5, 1; Paper 6, 1. Neither party contests the other’s assertions on this. C.” slip op. at 3

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A POSA at the time of the claimed invention would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices. Additional work experience could substitute for a formal degree and vice versa. Ex.1003, ¶21. Pet. 20 (citing Ex. 1003). Patent Owner does not contest this proposed definition or offer an alternative. See generally Resp. We accept and use Petitioner’s uncontested definition of the ordinarily skilled artisan, which appears to comport with the level of skill in the art reflected in the prior art of record and the ’943 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may]” slip op. at 19

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

    “same claim construction standard that is used to construe patent claims in a civil action in federal district court. 37 C.F.R. § 42.200(b). In construing claims, district courts and the Board here, by default, give claim terms their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner states that, “no terms require construction for purposes of this Petition.” Pet. 21. Patent Owner presents no express position on claim construction. See generally Resp. We do not expressly construe any claim terms. E.” slip op. at 20

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

    “question, based on factual findings. VidStream, 981 F.3d at 1063–64. Moreover, public accessibility is the touchstone in determining whether a reference is a printed publication and such depends on whether the reference was available to interested, ordinarily skilled persons exercising reasonable diligence, which is determined on a case-by-case basis. Id. at 1065. Particularly pertinent here is that “[w]hen there is an established publisher there is a presumption of public accessibility as of the publication date.” Id. Hulu (which cites VidStream on this issue) concerned, inter alia, whether certain asserted references were shown to be publicly available and could be considered as prior art. Hulu, 2021 WL 487622. Hulu holds that, although testimonial evidence is one way to prove public accessibility, there are also a variety of hallmarks of publication and other evidence that may be considered as a totality of the evidence to determine if an asserted reference was publicly accessible and prior art. Id. at *10–13, 21. Facts to be considered in analyzing the issue, other than testimonial evidence, include, for example, whether there is an established publisher, a copyright date/notice, other publication-related dates (impression, printing, etc.), an ISBN number, citations to the reference before (and to a lesser degree, after) the priority date at issue corroborating its availability and/or that the publisher was established, and whether the reference’s “purpose of publishing . . . was ‘dialogue with an intended audience.’” Id. at *10–21 (citing Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1374 (Fed. Cir. 2021)).” slip op. at 30

  Patent outcomesUS 11,844,943 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · Graham
  Patents in suitUS 11,844,943
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 17, 2025 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–30 are unpatentable: claims 1–2, 4–7, 9–12, 14–17, and 19–30 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious over the cited combinations.

  RulingsFinal written decision

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

    “We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 10

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artDecided for petitioner

    “Patent Owner does not direct us to evidence that it attempted to file any patent application before the publication date of the MSI-H clinical study and was denied an earlier filing date. Contrary to Patent Owner’s argument that it could not file a patent application without results from the MSI-H clinical study, we note that the inventors filed a provisional patent application on November 13, 2014, which, although also filed more than a year after the publication of the MSI-H clinical study, disclosed no clinical results or data. Ex. 1001, cover; Ex. 1030, 1. After considering the parties’ arguments, we are not persuaded by Patent Owner’s assertion that the inventors could not have filed an earlier application to at least attempt to secure a priority date before the MSI-H clinical study was publicly available. an earlier filing date. Instead, we are persuaded by Petitioner’s argument that because the MSI-H clinical study was published before the inventors filed an application to protect their patent rights the MSI-H clinical study is prior art for the information it discloses. Accordingly, we proceed to analyze Petitioner’s contentions in Ground 1.” slip op. at 24

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

    “the genus disclosed in the MSI Study Record and does not argue or provide evidence to show that one of ordinary skill in the art could have envisaged each species within that genus. PO Resp. 11–14. We are not persuaded that either the size of the genus in the MSI Study Record or whether one of ordinary skill in the art would have been able to envisage every species within it is dispositive of whether the MSI Study Record anticipates claim 1, where one of ordinary skill in the art would have known that specific cancers recited in claim 1 would be included in the MSI Study Record. As Petitioner argues, claim 1 requires that “a patient…selected from the group consisting of [the listed cancers]” be tested and treated. Pet. Reply 10 (emphasis original). Claim 1 does not require that the patient have each and every one of the sixteen listed cancers to anticipate the claim. Rather, claim 1 requires testing a sample from “a patient” with one of the recited types of cancer and treating the patient. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”).” slip op. at 31

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “In contrast, the testimony of Patent Owner’s witness, Dr. Goldberg, supports Petitioner’s argument of the knowledge in the art at the time, wherein Dr. Goldberg testifies that “[w]hile many clinical oncologists were aware that patients with Lynch Syndrome had a defect in DNA mismatch repair, they associated MSI testing with young onset colorectal and endometrial cancer and patients with a family history of colorectal and/or endometrial cancer.” Ex. 2090 ¶ 79. Similarly, during his deposition, Dr. Goldberg also agreed that endometrial, gastric, and small-bowel cancers would come to mind when he saw a reference to MSI-high non-colorectal cancer. See Ex. 1243, 115:5–116:22 (Q. And so does endometrial cancer come to mind when you see reference to MSI-high non-colorectal cancers? . . . A. Yes. Q. As . . . a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does gastric cancer come to mind? . . . A. comes to mind. So the answer is yes. Q. As a person of skill in the field, when you see reference to MSI-high non-colorectal cancers, does small bowel cancer come to mind? . . . A. Yes.”). Patent Owner does not direct us to other evidence contradicting Petitioner’s argument that MSI-H was known to occur in endometrial, small bowel, and gastric cancer. Pet. 18.” slip op. at 30

  Patent outcomesUS 11,643,462 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,643,462
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 6, 2025 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–7 are unpatentable: claims 1–3 and 5–7 are anticipated by the MSI-H Study Record, and claim 4 is obvious over the MSI-H Study Record and other cited references.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “On balance, we find Petitioner’s evidence more persuasive of what one of ordinary skill in the art would have understood from the MSI-H Study Record. We find Dr. Neugut’s and Dr. Oberstein’s testimony, and Dr. Lonberg’s lack of clear testimony to the contrary, persuasive as to this issue. In addition, we are not persuaded by the case law cited by Patent Owner regarding inherent anticipation. See PO Resp. 6–7. Rather, we agree with Petitioner that the correct inquiry is whether the skilled artisan would have understood that all limitations are disclosed in the prior art. See Pet. 34–35; Pet. Reply 12–13. In light of the cited testimony, we are persuaded that Petitioner has met its burden of proving that a skilled artisan would reasonably have understood or inferred that the limitation for a patient having received a prior cancer therapy drug to treat the tumor was disclosed in the MSI-Study Record. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSI-H Study Record, not what it inherently discloses. Contra PO Resp. 6–9.” slip op. at 22

  • Skill levelSkill level board ownDecided for petitioner

    “In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’974 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

  Patent outcomesUS 11,325,974 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,974
• Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentable
  PTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8

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

    “The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7

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

    “record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24

  Patent outcomesUS 11,325,975 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,325,975

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.