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  • 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
  • PTAB · Feb 17, 2026 · IPR2024-01132 · APJ Kevin W Cherry · IPR · Final written decision

    Claims 1–7 are unpatentable: claims 1–3 and 5 are anticipated by Anzai, claim 4 is obvious over Anzai and Yamazaki, and claims 1–7 are obvious over Yamazaki and Anzai.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner describes a person of ordinary skill in the art (“POSITA” or “ordinarily skilled artisan”) at the time of the invention as having “a Bachelors’ degree in electrical engineering or a comparable field of study, plus approximately two to three years of professional experience with electronic and optoelectronic device design” and notes that “[a]dditional graduate education could substitute for professional experience, and significant experience in the field could substitute for formal education.” Pet. 5–6 (citing Ex. 1002, Neikirk Decl., ¶ 23). Patent Owner’s expert, Dr. Bretschneider testifies that In my opinion, the field of “electronic and optoelectronic device design” is too broad. A POSITA of the ’121, had at least a Bachelors’ degree in a field of engineering or physics and at least two to three years of professional experience related to the design and manufacture of the relevant aspects of flat panel displays. Additional relevant graduate education related [sic] could reduce but not eliminate the time requirement for professional experience. While Dr. Neikirk proposes a different definition of a POSITA, the differences do not have material effect on my opinions rendered below. Regardless of which definition of a POSITA were used, my conclusions would remain the same Ex. 2005, Bretschneider Decl., ¶ 39. We agree with and will apply Petitioner’s statement of the level of ordinary skill in the art. This level of ordinary skill is reflective of the education and experience that would have been required to understand the problems and solutions identified in the ’121 patent and the prior art. Okajima v. Bourdeau, 261 F.3d 1350 (Fed. Cir. 2001). We note that our conclusions would be the same even if we applied Patent Owner’s slightly narrower definition of a POSITA.” slip op. at 11

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

      “We find these definitions to be of some help in construing this term. We find that the common thread is that a “passivation layer” is an insulating layer that provides protection from the environment to the layers below it. See Ex. 1012, 140; Ex. 1013, 542, Ex. 1014, 798; Ex. 2010, 3; Ex. 2013, 1. We find this construction to be most consistent with the broad claim language and the disclosure in the Specification. Although “tying up dangling bonds,” may be a mechanism by which some materials provide such protection, nothing in the Specification or the extrinsic evidence provided appears to require that. Also, while chemical protection may be one kind of protection none of the evidence suggests that is the only protection that is provided. Moreover, nothing in the Specification supports reading a chemical protection requirement into the construction. Thus, we decline to adopt that portion of Patent Owner’s construction. Instead, we construe passivation layer as “an insulating layer that provides protection from the environment to the layers below it.” We need not construe the term any further to resolve the parties’ dispute over this claim language. See Realtime, 912 F.3d at 1375.” slip op. at 19

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

      “constructions for “passivation layer” and “capping layer.” We find that Petitioner has presented sufficient evidence to show that Anzai discloses both a “passivation layer” and a “capping layer.” As we explained above, we have construed “passivation layer” to mean “an insulating layer that provides protection from the environment to the layers below it.” Petitioner has shown that “first planarization film 17” is an insulating layer. See Ex. 1002 ¶¶ 62–65. We further find that Petitioner has shown sufficiently that “first planarization film 17” is “formed over the entire surface for flattening, which will protect the semiconductor surface from the surrounding environment.” Id. ¶ 63. We have rejected Patent Owner’s contentions that the film must tie up “dangling bonds,” and instead determined that protecting the surface from the environment is sufficient. Thus, we find that Petitioner has shown by a preponderance of the evidence that Anzai discloses the “passivation layer” of claim 3. As we explained above, we have construed “capping layer” to be “an insulation layer covering (i.e., capping) an underlying layer or structure.” Here, Petitioner has shown that Anzai’s planarization film 19 meets the claimed “capping layer.” See Pet. 20. We find that Petitioner has shown that it is more likely than not that “planarization film 19” is made of insulating material. As Dr. Neikirk persuasively testifies, Anzai discloses that planarization layer 17 may be made of an organic resin for flattening the surface. EX1003, 4:20-24. While Anzai does not disclose the material for planarization layer 19, it must be made of an insulation material because in the embodiment of Fig. 3A, it is the sole layer between electrode layer 71 and cathode layer 65 forming the second capacitor. Id., 6:3–8; Fig. 3A. Moreover, Anzai discloses that the first planarization film 17 and the second planarization film 19 for the first embodiment “function as the capacitance insulating film for this configuration.” Id., 5:62–67. Ex. 1002, Neikirk Decl., ¶ 62. We find this testimony well-reasoned and entitled to substantial weight. We further agree with Dr. Neikirk that a “POSITA would further understand that the second planarization film 19 is then further disposed on the first planarization film 17 (capping the passivation layer).” Id. ¶ 63 (citing Ex. 1003, 5:3–13; Figs. 2A–B, 3A–B). Thus, we find that Petitioner has shown by a preponderance of the evidence that Anzai discloses the claimed “capping layer.” Accordingly, we find that Petitioner has shown by a preponderance of” slip op. at 32

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

      “motivation to combine Anzai and Yamazaki. See Pet. 25–27; Ex. 1002, Neikirk Decl., ¶¶ 78–79. First, Patent Owner argues that essentially silicon nitride is an inferior material to use for Anzai’s planarization layer 17 compared with organic resin. PO Resp. 13–15. However, “[i]t’s not necessary to show that a combination is the best option, only that it be a suitable option.” Intel Corp. v. Qualcomm Inc., 21 F.4th 797, 800 (Fed. Cir. 2021) (emphasis in original). Patent Owner does not argue that silicon nitride would not work, but rather that it would be more difficult and more expensive to use. See PO Resp. 14. But “the fact that the two disclosed apparatus[es] would not be combined by businessmen for economic reasons is not the same as saying that it could not be done because skilled persons in the art felt that there was some technological incompatibility that prevented their combination. Only the latter is telling on the issue of nonobviousness.” Grit Energy Solutions LLC v. Oren Techs., LLC, 957 F.3d 1309, 1323 (Fed. Cir. 2020) (quoting Orthopedic Equip. Co., Inc. v. United States, 702 F.2d 1005, 1013 (Fed. Cir. 1983)). “Likewise, a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Here, Petitioner explains that “a POSITA would have known that organic materials usually have lower dielectric constants than inorganic materials, such as SiN, and a higher dielectric constant is desirable for the insulator in a capacitor since that leads to higher capacitance per unit area.” Pet. 26 (citing Ex. 1002, Neikirk Decl., ¶ 78). Petitioner further explains that this “then allows a reduced area storage capacitance element, one of the objectives of Anzai.” Id. (citing Ex. 1003, code (57)). Patent Owner’s focus mainly on planarization (PO Sur-reply 16–17) ignores that the Anzai’s planarization layers 17 and 19 also “function as the capacitance insulating film.” Ex. 1003, 5:65–67. Thus, although there are tradeoffs, Petitioner has shown sufficiently that a POSITA would have been motivated to incorporate the teachings of Yamazaki regarding potential materials for planarization layers 17 and 19. Second, Patent Owner argues that a Petitioner has failed to provide an adequate reason to select silicon nitride from Yamazaki’s list of potential materials. We disagree. Petitioner has explained the benefits of selecting a high dielectric inorganic material. Pet. 26. Yamazaki provides only three potential options—silicon oxide, silicon nitride, and silicon oxynitride. See Ex. 1004, 11:45–50. Moreover, Dr. Neikirk testified, supported by multiple references, that using silicon nitride was well known in the prior art at the time of the invention. See Ex. 1002, Neikirk Decl., ¶ 75 (citing Ex. 1007; Ex. 1008; Ex. 1009). “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.” KSR, 550 U.S. at 421. Indeed, “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. This is the case here. Petitioner has shown that a person of ordinary skill seeking to improve the capacitance of Anzai’s planarization layers 17 and 19, without increasing the size of the capacitor, would have looked at the inorganic materials identified in Yamazaki as suitable for the purpose, and it would have been would obvious to choose silicon nitride, a well-known, and predictable material for the application. Thus, we disagree with Patent Owner that Petitioner has failed to show a sufficient reason for selecting silicon nitride from Yamazaki’s list of suitable materials. Third, Patent Owner argues that Petitioner’s contentions only support” slip op. at 37

    Patent outcomesUS 7,586,121 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,586,121
  • PTAB · Jan 26, 2026 · IPR2024-01133 · APJ Thu A Dang · IPR · Final written decision

    Claims 1–13 are unpatentable: claims 1–5, 9, and 12–13 as anticipated by Weaver, and claims 6–8 and 10–11 as obvious over the stated combinations.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001) (holding that absent evidence to the contrary, “the prior art itself [may] reflect[] an appropriate level” of ordinary skill in the art). In general, we agree with the areas of agreement in the parties’ proposals. In particular, Patent Owner proposes “at least a Bachelors’ degree in a field of engineering or physics,” which includes “electrical engineering or a comparable field of study” as Petitioner proposes. Pet. 4 (emphasis added); PO Resp. 10. We agree with Petitioner that by defining the engineering field as “electrical” or “comparable,” we can exclude engineering fields “having nothing to do with displays, such as biomedical, civil, chemical or environmental engineering.” Pet. Reply 1. Petitioner also proposes approximately “one or more years of professional experience” which includes Patent Owner’s “at least two years of professional experience.” Pet. 4; PO Resp. 10. Furthermore, both parties agree that “[a]dditional graduate education could [reduce . . . the time requirement] for professional experience.” Id. Thus, we adopt both parties’ proposed POSITA of having a Bachelors’ degree in electrical engineering or a comparable field of study, plus at least two years of professional experience, wherein additional graduate education could reduce the time requirement for professional experience. Id. Such proposal comports with the level of ordinary skill in the art reflected in the prior art of record.” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

      “The plain language in claim 1 of “auxiliary electrode” does not preclude that the “electrode” may be a power line, bus line, or resistor. Ex. 1001, 8:47–52. Nothing in the Specification clearly precludes “auxiliary electrode” from being a “bus line” or “power line,” as Patent Owner proposes. PO Resp. 25–27. We are unpersuaded by Patent Owner’s contention that the Specification discloses that “the power line ‘PL’ is shown in Figure 1, but the power line PL is not an electrode that is shown in Figure 2.” Id. at 26–27. Here, Patent Owner points to no portions in the Specification that provide the requisite “reasonable clarity, deliberateness, and precision” to warrant interpreting the claim language at issue as supporting Patent Owner’s contention that an auxiliary electrode cannot be a power line, bus line, or resistor. Id.; In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1984). That is, although Patent Owner points to Figures 1 and 2 of the Specification for support of its contention, Figures 1 and 2 of the Specification merely show various examples of power line and an auxiliary electrode. PO Resp. 26–27. Thus, although the referenced portions of the Specification discuss various examples wherein an auxiliary electrode may be implemented, nothing in these referenced portions of the Specification clearly precludes the “auxiliary electrode” from being a power line or any electrode that is “the road to get to an end point,” as Patent Owner contends. Id. Patent Owner points to no special definition, implicit or explicit, for “auxiliary electrode” that is set forth in the Specification which supports Patent Owner’s construction with reasonable clarity, deliberateness, and precision. Paulsen, 30 F.3d at 1480.” slip op. at 15

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

      “We find Patent Owner’s arguments unavailing. In particular, we find unavailing Patent Owner’s contention that “‘bus line 430’ is not an ‘auxiliary electrode’” (PO Resp. 28–33), because Patent Owner is relying on a claim construction of “auxiliary electrode” as precluding “essential” elements and requiring “more than the end structure of a conductor” (id.), that is not adopted by our construction discussed above. Here, we are persuaded by Petitioner’s reliance on Weaver’s bus line 430 for providing the claimed “electrode,” that is “supplemental to other electrodes in the structure.” Pet. 18; see also Ex. 1004 ¶ 26, Fig. 4; Ex. 1003 ¶ 92. We find availing Petitioner’s contention, supported by Dr. Baker’s testimony, that a POSITA would have understood that “anode 406 and bus line 430 are connected in parallel,” which means that “bus line 430 is a supplemental electrode that reduces the total resistance of the pixel structure.” Pet. 19; Ex. 1003 ¶ 94. Thus, we find availing Petitioner’s contention, supported by Dr. Baker’s testimony, that Weaver’s bus line 430 is an electrode supplemental to other electrodes in the structure that is electrically insulated from transistor 410 by passivation layer 409, wherein OLED 400, which includes cathode 422, organic layer 424, and anode 406, is disposed above bus line 430, and wherein anode 406 of OLED 400 is electrically connected to bus line 430 by via 428. Pet. 16–19; Ex. 1003 ¶¶ 89–94. That is, we find availing Petitioner’s contention that, like the ’509 patent’s auxiliary electrode 120, bus line 430 is electrically insulated from transistor 410, wherein OLED 400 is disposed above bus line 430 and anode 406 electrically connected with bus line 430. Compare Pet. 2–3 (annotated” slip op. at 26

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

      “We also find unavailing Patent Owner’s contention that the proposed modifications to Weaver would involve changing the process. PO Resp. 33– 34. We agree with Petitioner, whose contentions are supported by Dr. Baker’s testimony, that “to provide additional components from the same layer is a layout change that a POSITA would have been able to perform without changing the process.” Pet. Reply 17–18 (citing Ex 1003 ¶ 157; Ex. 1020 ¶ 45). Further, contrary to Patent Owner’s contention that POSITA would not have combined Weaver with Lee ’053, Song, Lee ’149, or Bae without the use of hindsight (PO Resp. 33–45), as Petitioner points out, Lee ’149, for example, “explicitly teaches that ‘the electrode pattern 45 serves to lower the resistance of the first electrode 41.” Pet. Reply 58 (citing Ex. 1011 ¶ 38). Similarly, Bae “explicitly teaches that the “auxiliary electrodes 139 contact the first electrode 132 to commonly apply a voltage to the sub-pixels” and “reduces the resistance of the first electrode.” Id. at 66 (citing Ex. 1012 ¶¶ 37, 59). As such, Petitioner’s proposed combinations are supported by at least by Lee ’149’s and Bae’s teachings of applying a second electrode to lower the resistance and voltage drop between anode 406 and the VDD line of Weaver. See, e.g., Ex. 1011 ¶ 38; Ex. 1012 ¶¶ 37, 59. We are persuaded by Dr. Baker’s testimony that a POSITA would have understood that higher resistance between the power or ground line to the light emitting device would consume more power and require higher operating voltages, and thus, would have been motivated to implement the solutions of Lee ’053, Song, Lee ’149, or Bae to lower the resistance between anode 406 and voltage source VDD in Weaver. Ex. 1003 ¶¶ 145, 158, 184, 203. We agree with Petitioner, supported by Dr. Baker’s testimony, that a POSITA would have had a reasonable expectation of success the combining the references as suggested, wherein such modification “involves modifications of only routine skill in the art,” which “involve known method,” and “would have yielded predictable results. Pet. 42, 48–49, 59, 67–68; Ex. 1003 ¶¶ 145, 158, 184, 203. That is, we determine that Petitioner has set forth reasoning with rational underpinning explaining why it would have been obvious to combine the teachings with a reasonable expectation of success. Based on the complete record presented, we determine Petitioner has shown by a preponderance of the evidence that claims 6–8 would have been obvious over the combination of Weaver and Lee ’053 or alternatively over the combination of Weaver and Song, and that claims 10 and 11 would have been obvious over the combination of Weaver and Lee ’149 or alternatively over the combination of Weaver and Bae.” slip op. at 33

    Patent outcomesUS 9,263,509 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,263,509
  • PTAB · Jan 14, 2026 · IPR2025-01191 · APJ Kara L Szpondowski · IPR · Institution

    The Board instituted IPR on claims 1–24 and all asserted grounds because the petition showed a reasonable likelihood of prevailing on at least one claim.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “Institution of an inter partes review is authorized when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Based on the current record, and for the reasons explained below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one challenged claim, and we institute an inter partes review.” slip op. at 2

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “IV. PATENT OWNER’S 35 U.S.C. § 325(D) ARGUMENTS Patent Owner presents arguments directed to discretionary considerations under 35 U.S.C. § 325(d) and requests the Petition be denied based on these arguments. Prelim. Resp. 2–16. However, Patent Owner’s § 325(d) arguments are untimely under the “Interim Director Discretionary Process,”6 and, as such, will not be considered by the Board. See Section I.C. (“The . . . patent owner should not present discretionary considerations in the . . . Patent Owner Preliminary Response (POPR)”); Section I.E. (“[A] Board panel will issue a decision on institution addressing the merits and other non-discretionary considerations.”). 5 Available at https://www.uspto.gov/patents/ptab/trial-practice-guide#step1 6 https://www.uspto.gov/patents/ptab/interim-director-discretionary-process.” slip op. at 38

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

      “Petitioner bears the burden of establishing that Wang is a printed publication. Medtronic, 891 F.3d at 1380. The determination of whether a document is a “printed publication” “involves a case-by-case inquiry into the facts and circumstances surrounding the reference's disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). “[A]t the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, IPR2018-01039, Paper 29 at 13.” slip op. at 19

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

      “A claim is unpatentable as anticipated under 35 U.S.C. § 102 “if each and every limitation is found either expressly or inherently in a single prior art reference.” WhitServe, LLC v. Computer Packages, Inc., 694 F.3d 10, 21 (Fed. Cir. 2012) (quoting Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998)). An anticipatory reference must also “disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)).” slip op. at 11

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,822,165
  • 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
  • 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
  • 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
  • PTAB · Nov 3, 2025 · IPR2022-00431 · APJ Eric C Jeschke · IPR · Remand

    On remand, claims 1–3 and 8–12 are unpatentable over the instituted grounds; claim 4 was not shown unpatentable.

    RulingsRemand decision
    • RemandOther

      “Federal Circuit (Paper 33), which vacated the original Final Written Decision and remanded the proceeding to the Board. See ReCor Med., Inc. v. Medtronic Ir. Mfg. Unlimited Co., No. 2023-2251, 2025 WL 944511 (Fed. Cir. Mar. 27, 2025) (“the Appeal Decision” or “Appeal Dec.”); see also Paper 41 (copy of the Appeal Decision). The Federal Circuit’s mandate issued on May 5, 2025. See Paper 40. We have jurisdiction under 35 U.S.C. § 6, and we issue this Final Written Decision on Remand under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons below, on the complete record, we conclude that Petitioner has proven, by a preponderance of the evidence, the unpatentability of claims 1–3 and 8–12 of the challenged patent, and we conclude that Petitioner has not proven, by a preponderance of the evidence, the unpatentability of claim 4.” slip op. at 2

    • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentable

      “and Petitioner’s rebuttal evidence. Objective evidence of nonobviousness, when present, must be considered as part of an obviousness inquiry. Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Notwithstanding what the teachings of the prior art would have suggested to one of ordinary skill in the art, the totality of the evidence submitted, including objective evidence of nonobviousness, may lead to a conclusion that one or more of the challenged claims would not have been obvious to one of ordinary skill in the art. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984).” slip op. at 50

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

      “1. Claims 1–3 and 8–11 Because the obviousness ground based on Levin and Acker is dispositive as to challenged claims 1–3 and 8–11, we need not reach this additional ground as to those claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 371 (2018) (holding that a petitioner “is entitled to a final written decision addressing all of the claims it has challenged”); Boston Sci. Scimed, analysis in the appeal to the Federal Circuit. See Appeal Dec. *1–*2 (summarizing grounds at issue on appeal and not discussing anticipation based on Acker). Inc. v. Cook Grp. Inc., 809 F. App’x 984, 990 (Fed. Cir. 2020) (nonprecedential) (stating that the “Board need not address issues that are not necessary to the resolution of the proceeding,” such as “alternative arguments with respect to claims [the Board] found unpatentable on other grounds”); SK Hynix Inc. v. Netlist, Inc., IPR2017-00692, Paper 25 at 40 (PTAB July 5, 2018) (determining all challenged claims to be unpatentable and not addressing additional grounds). 2. Dependent Claim 4 As to dependent claim 4, in the context of this ground, Petitioner relies on Acker as to the additional limitations in claim 4 in the same manner as relied on in the context of the ground based on Levin and Acker. See Pet. 73 (“The combination teaches this element for the same reasons described in [the obviousness ground based on Levin and Acker], claim 4, with the exception that [one of ordinary skill in the art] would have been motivated based on his or her knowledge of prior renal denervation work, as noted above.”). Thus, for the same reasons discussed above (see § II.C.3.c), we determine, based on the complete record, that Petitioner has not demonstrated by a preponderance of the evidence that claim 4 would have been obvious based on Acker and the knowledge of one of ordinary skill in the art. G. Asserted Obviousness of Claim 12 Based on Acker, the Knowledge of a Person of Ordinary Skill in the Art, and Yock Petitioner asserts that claim 12, which depends from independent claim 1, would have been obvious based on Acker, the knowledge of one of ordinary skill in the art, and Yock. Pet. 12, 75; Pet. Reply 35–36. Patent Owner provides arguments addressing this ground. PO Resp. 57–60; PO” slip op. at 75

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

      “1. Independent Claim 1 Petitioner contends that Acker discloses each limitation of claim 1. Pet. 61–63; Pet. Reply 35. In the “Overview of the Ground” section, Petitioner references its proposed construction of the phrase “configured to” and states that “it is proper to consider whether the prior art is ‘capable of’ performing the recited functions, as opposed to requiring that a designer of a prior art device have actually conceived of the recited functional language.” Pet. 61. Petitioner continues: “If the PTAB agrees that this is the proper approach to claim construction, then Acker also anticipates the claims challenged in this ground.” Id. For the reasons below, we determine, based on the complete record, that Petitioner has not demonstrated by a preponderance of the evidence that claim 1 is anticipated by Acker. As to element 1d, which includes the phrase “configured to,”16 Petitioner states that Acker is capable of being used to target renal neural fibers outside of the blood vessel to thermally induce modulation of target neural fibers while protecting non-target tissue in the blood vessel wall from thermal injury for the reasons discussed under claim 1, limitation [1d] and in the section entitled “Reasonable Expectation of Success”, beginning on page 37 [of the Petition]. Pet. 62–63 (citing Daft Pet. Decl. ¶ 179) (first bracketed text added by Petitioner). Patent Owner argues that, in the context of this asserted ground based” slip op. at 71

    Patent outcomesUS 8,845,629 mixed
    § 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 8,845,629
  • PTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision

    Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.

    RulingsFinal written decision
    • BurdenUnpatentable

      “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full 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 ’356 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” slip op. at 22

    • Skill levelSkill level board ownDecided for petitioner

      “Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (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. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. 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 ’356 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

    • 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. 10–11; 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 claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable

      “(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full 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 ’356 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” slip op. at 22

    Patent outcomesUS 10,934,356 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,934,356
  • PTAB · Oct 1, 2025 · IPR2024-00703 · APJ Meredith C Petravick · IPR · Final written decision

    Claims 1–58 were not shown unpatentable: the Edwards, Ingle, and Mosher combination fails to establish key limitations, and Ollivier was not shown to be a prior art printed publication.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “We apply Patent Owner’s proposed definition, as it appears consistent with the field of the ’511 patent and the prior art and is consistent with testimony of Dr. Poulos and the cross-examination testimony of Dr. Berenholz. See Okajima v. Bourdeau, 261 F.3d 1350, 1355, (Fed. Cir. 2001) (the level of ordinary skill in the art may be reflected in the prior art itself); Ex. 2001 ¶¶ 35–39; Ex. 2005, 55:5–17, 57:17–58:19. In our view, however, Petitioner’s proposed definition is not so different that our decision would change if we were to apply Petitioner’s proposed definition.” slip op. at 9

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

      “Patent Owner’s argument are persuasive. We agree with Patent Owner that a plain reading of the wherein clause requires the treating to begin at the introitus and extend at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. This construction is consistent with the ’511 patent’s Specification, which states: In typical embodiments, the length of the energy delivery element is about 1 to about 3 cm in length, in other embodiments it may be as long as about 4 cm. This is a length well adapted to treating the lower aspects of the vagina, wherein treatment by the method comprises contacting the vaginal epithelium in a region that extends from the introitus inward to a position about 3 to 4 cm inward from the introitus. In some embodiments of the invention, the method can b[e] practiced with a single row of parallel contract sites immediately inside the introitus. In other embodiments, the method may include deeper rows, or rows that overlap an initial row, while keeping the contact sites within the lower portion of the vagina. Ex. 1001, 3:28–40 (emphasis added); see also id. at 14:47–57. The ’511 patent Specification also states: “the portion of the vagina to be treated is a region between the introitus and a position located no further than about 3 to about 4 cm inward from the introitus.” Id. at 11:48–51 (emphasis added). Given the plain language of claim 1, consistent with the ’511 patent’s Specification, we construe “heating a portion of the vagina extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus” to require heating a portion of the vagina beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus.” slip op. at 12

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

      “Patent Owner’s arguments is persuasive. The cited portion of Mosher does not explicitly state the location of the treatment area. Ex. 1006 ¶ 74. In it Reply, Petitioner additionally points to paragraph 54 of Mosher, which states: “Preferably, the location of the treatment volume of endopelvic fascia will be disposed along a length of the urethra between the bladder neck and the external meatus so as to avoid injuring nerves.” Pet. Reply 14 (quoting Ex. 1006 ¶ 54). Petitioner argues that “[t]reating the vaginal wall adjacent to the mid-urethral region is within the claimed region of ‘from 1 cm to 3.5 cm in from the introitus.’” Pet. Reply 14–16. This, however, does not teach the claimed area beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. The Petition fails to show that either Edwards or Mosher discloses heating a portion of the vagina beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. In its Reply, Petitioner argues that it would have been obvious to modify Edwards to treat the area beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. See, e.g., Pet. Reply 2–4, 16–17 (citing Pet. 35). The Petition’s argument is unpersuasive because it is conclusory and does not adequately address Edwards’s use of a speculum. Pet. 35. The Petition includes no” slip op. at 26

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

      “In its Reply, Petitioner argues that it would have been obvious to modify Edwards to treat the area beginning at the introitus and extending at least the first centimeter into the vagina and up to 3.5 cm in from the introitus. See, e.g., Pet. Reply 2–4, 16–17 (citing Pet. 35). The Petition’s argument is unpersuasive because it is conclusory and does not adequately address Edwards’s use of a speculum. Pet. 35. The Petition includes no persuasive explanation as to why it would have been obvious to modify Edwards to use the treatment blade without the speculum. See Pet. 22–24, 35–36. We determine that Petitioner fails to meet its burden to show by a preponderance of the evidence that claim 1 is unpatentable over Edwards, Ingle, and Mosher.” slip op. at 26

    Patent outcomesUS 8,961,511 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 8,961,511
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