- Cambridge Industries USA, Inc. / Accelight Technologies, Inc. v. Applied Optoelectronics, Inc.No claims unpatentablePTAB · Jul 27, 2026 · IPR2025-01570 · APJ Monica S Ullagaddi · IPR · Final written decision
The majority held claims 1–19 not shown unpatentable: Wang did not anticipate claims 1–10, and Wang with Xiong did not render claims 11–19 obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedOther
“field of the ’690 Patent would have had at least (1) an undergraduate degree in electrical engineering, computer engineering, computer science, or a comparable field of study and (2) at least two years of experience with optical data communications or a comparable field of work.” Pet. 14 (citing Ex. 1003 ¶ 22). Petitioner also states that “[i]ndividuals having different educational backgrounds and supplemental experience might still be of ordinary skill in the art if such experience compensates for any deficiencies in education relative to the criteria stated above” and “[i]n some cases, additional education might be an acceptable substitute for some experience, or vice versa.” Id. Patent Owner does not dispute Petitioner’s characterization of the level of skill in the art. See e.g., PO Resp. 9. We adopt Petitioner’s unopposed definition of the level of ordinary skill in the art as it appears consistent with the disclosures of the ’690 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Patent is self-explanatory and would have been recognized by a [person of ordinary skill in the art] as having plain and ordinary meanings.” Pet. 10. “Petitioner submits that no special constructions are required” because “the claim terms appear understandable in the context of the disclosure provided by the specification of the ’690 Patent.” Id. (citing Ex. 1003 ¶ 58). Patent Owner “agrees that the claim terms should be given their plain and ordinary meaning as understood by a [person of ordinary skill in the art].” PO Resp. 10. After reviewing the arguments and evidence before us, we determine that we do not need to expressly construe any claim term to resolve any controversy in the proceeding. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8
- BurdenNot shown unpatentable
“Also relevant to our analysis is that this is an anticipation ground and Petitioner is required to show that the reference discloses not only the elements of the claimed invention, but also discloses those elements as arranged in the claim. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Although our Institution Decision concluded that Petitioner had demonstrated a reasonable likelihood of prevailing with respect to its anticipation challenge to independent claim 1 applying Wang (Inst. Dec. 6), at this stage of the proceeding we are required to evaluate Petitioner’s challenges under a higher standard, the preponderance of evidence standard. For the foregoing reasons, we are not persuaded that Petitioner sufficiently establishes that claim 1 is unpatentable under 35 U.S.C. § 102 as anticipated by Wang by a preponderance of the evidence.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Wang discloses that “the isolator 100 is bonded to the substrate by means of an adhesive” in which “[t]he adhesive is not only used to fix the isolator 100 to the substrate, but also fills a gap between the isolator 100 and the substrate to improve the installation accuracy of the isolator 100.” Ex. 1006 ¶ 41 (emphasis added). Petitioner does not explain how filling in a gap between the isolator 100 and a substrate necessarily results in “each of the plurality of optical isolators [being] disposed substantially in parallel relative to each other,” as recited in claim 1. The cited portion in paragraph 43 references Figures 5 and 6, which depict Embodiment 1 of Wang and are reproduced below. Figures 5 and 6 of Wang depict isolators 100, base 311, and baffles 312. Although paragraph 44 of Wang states that “[t]he substrate includes a base 311, and baffles 312 and isolators 100 sequentially disposed on the base 311,” Petitioner does not sufficiently persuade us how Wang’s disclosure “sequentially disposed” isolators necessarily discloses that the isolators are “disposed substantially in parallel relative to each other” as recited in independent claim 1. Ex. 1006 ¶ 44. Although the cited portion in Figure 6 of Wang apparently shows a possibly parallel arrangement of Petitioner cites to Dr. Kirk’s Declaration, but Dr. Kirk does not opine on why cited portions of Wang necessarily disclose or depict the claimed “disposed substantially in parallel relative to each other” requirement. Ex. 1003 ¶¶ 73, 74; Ex. 1006 ¶¶ 41, 43, Figs. 6, 8, 10. At best, Dr. Kirk testifies that “a POSITA would have understood that Wang anticipates Claim 1.” Ex. 1003 ¶ 75. Also relevant to our analysis is that this is an anticipation ground and Petitioner is required to show that the reference discloses not only the elements of the claimed invention, but also discloses those elements as arranged in the claim. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Although our Institution Decision concluded that Petitioner had demonstrated a reasonable likelihood of prevailing with respect to its anticipation challenge to independent claim 1 applying Wang (Inst. Dec. 6), at this stage of the proceeding we are required to evaluate Petitioner’s challenges under a higher standard, the preponderance of evidence standard.” slip op. at 12
Patent outcomesUS 10,788,690 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,788,690 - Cambridge Industries USA, Inc. / Accelight Technologies, Inc. v. Applied Optoelectronics, Inc.No claims unpatentablePTAB · Jul 27, 2026 · IPR2025-00437 · APJ Monica S Ullagaddi · IPR · Final written decision
The majority held claims 1–19 not unpatentable: Wang did not establish anticipation of claims 1–10, and Wang with Xiong did not establish obviousness of claims 11–19.
RulingsFinal written decision- BurdenNot shown unpatentable
“Wang discloses that “the isolator 100 is bonded to the substrate by means of an adhesive” in which “[t]he adhesive is not only used to fix the isolator 100 to the substrate, but also fills a gap between the isolator 100 and the substrate to improve the installation accuracy of the isolator 100.” Ex. 1006 ¶ 41 (emphasis added). Petitioner does not explain how filling in a gap between the isolator 100 and a substrate necessarily results in “each of the plurality of optical isolators [being] disposed substantially in parallel relative to each other,” as recited in claim 1. The cited portion in paragraph 43 references Figures 5 and 6, which depict Embodiment 1 of Wang and are reproduced below. Figures 5 and 6 of Wang depict isolators 100, base 311, and baffles 312. Although paragraph 44 of Wang states that “[t]he substrate includes a base 311, and baffles 312 and isolators 100 sequentially disposed on the base 311,” Petitioner does not sufficiently persuade us how Wang’s disclosure “sequentially disposed” isolators necessarily discloses that the isolators are “disposed substantially in parallel relative to each other” as recited in independent claim 1. Ex. 1006 ¶ 44. Although the cited portion in Figure 6 of Wang apparently shows a possibly parallel arrangement of Petitioner cites to Dr. Kirk’s Declaration, but Dr. Kirk does not opine on why cited portions of Wang necessarily disclose or depict the claimed “disposed substantially in parallel relative to each other” requirement. Ex. 1003 ¶¶ 73, 74; Ex. 1006 ¶¶ 41, 43, Figs. 6, 8, 10. At best, Dr. Kirk testifies that “a POSITA would have understood that Wang anticipates Claim 1.” Ex. 1003 ¶ 75. Also relevant to our analysis is that this is an anticipation ground and Petitioner is required to show that the reference discloses not only the elements of the claimed invention, but also discloses those elements as arranged in the claim. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Although our Institution Decision concluded that Petitioner had demonstrated a reasonable likelihood of prevailing with respect to its anticipation challenge to independent claim 1 applying Wang (Inst. Dec. 6), at this stage of the proceeding we are required to evaluate Petitioner’s challenges under a higher standard, the preponderance of evidence standard.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Wang discloses that “the isolator 100 is bonded to the substrate by means of an adhesive” in which “[t]he adhesive is not only used to fix the isolator 100 to the substrate, but also fills a gap between the isolator 100 and the substrate to improve the installation accuracy of the isolator 100.” Ex. 1006 ¶ 41 (emphasis added). Petitioner does not explain how filling in a gap between the isolator 100 and a substrate necessarily results in “each of the plurality of optical isolators [being] disposed substantially in parallel relative to each other,” as recited in claim 1. The cited portion in paragraph 43 references Figures 5 and 6, which depict Embodiment 1 of Wang and are reproduced below. Figures 5 and 6 of Wang depict isolators 100, base 311, and baffles 312. Although paragraph 44 of Wang states that “[t]he substrate includes a base 311, and baffles 312 and isolators 100 sequentially disposed on the base 311,” Petitioner does not sufficiently persuade us how Wang’s disclosure “sequentially disposed” isolators necessarily discloses that the isolators are “disposed substantially in parallel relative to each other” as recited in independent claim 1. Ex. 1006 ¶ 44. Although the cited portion in Figure 6 of Wang apparently shows a possibly parallel arrangement of Petitioner cites to Dr. Kirk’s Declaration, but Dr. Kirk does not opine on why cited portions of Wang necessarily disclose or depict the claimed “disposed substantially in parallel relative to each other” requirement. Ex. 1003 ¶¶ 73, 74; Ex. 1006 ¶¶ 41, 43, Figs. 6, 8, 10. At best, Dr. Kirk testifies that “a POSITA would have understood that Wang anticipates Claim 1.” Ex. 1003 ¶ 75. Also relevant to our analysis is that this is an anticipation ground and Petitioner is required to show that the reference discloses not only the elements of the claimed invention, but also discloses those elements as arranged in the claim. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Although our Institution Decision concluded that Petitioner had demonstrated a reasonable likelihood of prevailing with respect to its anticipation challenge to independent claim 1 applying Wang (Inst. Dec. 6), at this stage of the proceeding we are required to evaluate Petitioner’s challenges under a higher standard, the preponderance of evidence standard. For the foregoing reasons, we are not persuaded that Petitioner” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“challenge set forth in the Petition by citing the background of the ’690 patent and Dr. Willner’s deposition testimony and characterizing the same as “admissions” of Patent Owner in Petitioner’s Reply, such “evidence” did not form the basis of Appellant’s original position set forth in the Petition.6 Petitioner’s arguments that all of the components recited in claim 11 “were known in the prior art” or that Dr. Willner admitted the same are unpersuasive at least because the Petition did not set forth this position. Contrary to Petitioner’s arguments during the oral hearing, the Petition does not present challenges based on “Applicant Admitted Prior Art.” See generally Pet.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“field of the ’690 Patent would have had at least (1) an undergraduate degree in electrical engineering, computer engineering, computer science, or a comparable field of study and (2) at least two years of experience with optical data communications or a comparable field of work.” Pet. 14 (citing Ex. 1003 ¶ 22). Petitioner also states that “[i]ndividuals having different educational backgrounds and supplemental experience might still be of ordinary skill in the art if such experience compensates for any deficiencies in education relative to the criteria stated above” and “[i]n some cases, additional education might be an acceptable substitute for some experience, or vice versa.” Id. Patent Owner does not dispute Petitioner’s characterization of the level of skill in the art. See e.g., PO Resp. 9. We adopt Petitioner’s unopposed definition of the level of ordinary skill in the art as it appears consistent with the disclosures of the ’690 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
Patent outcomesUS 10,788,690 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,788,690 - Boe Technology Group Co., Ltd. v. Optronic Sciences LLCAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,586,121 - Lenovo (United States), Inc. v. University Of RochesterSome claims unpatentablePTAB · Feb 2, 2026 · IPR2024-01225 · APJ Thu A Dang · IPR · Final written decision
Claims 1 and 3–7 are unpatentable as obvious; claims 8–12 were not shown unpatentable because the asserted grounds did not establish asynchronous operation between domains.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner
“specification is the ‘single best guide to the meaning of a disputed term,’ . . . and ‘is, thus, the primary basis for construing the claims.’” Trs. of Columbia Univ. in City of New York v. Symantec Corp., 811 F.3d 1359, 1362 (Fed. Cir. 2016) (citations omitted). Although Patent Owner contends that the Specification disparages systems that impose significant restrictions on the possible choices of frequencies (PO Resp. 21), we find availing Petitioner’s contention that “[s]upport for Patent Owner’s construction is absent from the specification.” Pet. Reply 10. As Petitioner points out, Patent Owner’s claim construction “appears to be based on a single paragraph of the ’443 patent referring to preexisting ‘synchronization schemes [that] restrict the phase relationship and relative frequencies of the clocks.” Id. That is, the only reference by Patent Owner to the Specification is that the Specification states that “Some synchronization schemes restrict the . . . relative frequencies of the clocks, thereby eliminating the need for hardware arbitration [27]. Unfortunately, these schemes impose significant restrictions on the possible choices of frequences.” PO Resp. 26 (citing Ex. 1001, 6:32–36). We agree with Petitioner that such disclosure in the Specification “does not describe how these synchronization schemes ‘restrict the phase relationship and relative frequencies’ with any specificity.’” Pet. the Specification that some schemes impose restrictions on the possible choices of frequency is not a disparagement of any system that has limited choices of frequency or would preclude the claims from covering such prior art techniques. Instead, as Petitioner points out, the Specification of the ’443 patent states “[t]he preferred embodiment uses four domains […] so that domains may vary somewhat in size and still be covered by a single clock.” Id. (citing Ex. 1001, 5:57–59). As Dr. Baker testified in support of Petitioner’s contention, “the preferred embodiment of the ’443 patent relies on a single external master clock that distributes a signal to the local PLL of each domain.” See Ex. 1032 ¶ 9. Thus, although Patent Owner contends that clock signals generated based on a master clock cannot be interpreted to be generated independently of the clock signals generated for others of the plurality of domains (PO Resp. 49), we agree with Petitioner that such claim construction would “exclude[] the preferred embodiment of the ’443 patent,” which is disfavored. Pet. Reply 11. For the reasons discussed above, we conclude that “changeable independently” of the other domains does not require that the separate clocks in the plurality of domains be globally-asynchronous.” slip op. at 12
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner
“As both parties recognize, (PO Resp. 5; Pet. Reply 12), “[actual] [r]eduction to practice in the United States requires that the invention be embodied in tangible form.” Scott v. Koyama, 281 F.3d 1243, 1247 (Fed. Cir. 2002). In particular, actual reduction to practice requires a showing of the invention in a physical or tangible form that shows every element. not sufficient. See Kimberly-Clark v. Johnson & Johnson, 745 F.2d 1437, 1445 (Fed. Cir. 1984). Here, Patent Owner does not provide any evidence showing every element of the claims in physical or tangible form, as required, but rather contends that the Specification refers to the Paper, wherein the Paper stated that simulation using a software, SimpleScalar, was performed. PO Resp. 16. We are persuaded by Petitioner’s contention that the SimpleScalar simulation was not an actual reduction to practice of the claimed invention. Pet. Reply 12. As Petitioner points out, claim 1, for example, is directed to a “microprocessor,” wherein “Patent Owner has presented no evidence and has not alleged that any physical microprocessor was ever produced or operated.” Id. at 13; see PO Resp. 15–17. And as Petitioner points out, “Patent Owner has produced no evidence of any physical prototype of the claimed microprocessor that could have validated the simulation.” Pet. Reply 13–14. We agree with Petitioner that, at most, such simulation “demonstrated feasibility for prototyping of a microprocessor,” but not a tangible form of the microprocessor itself as required for an actual reduction to practice. Id. at 14; see also Standard Mfg. Co. v. United States, 25 Cl. Ct. 1, 67 (1991) (“The feasibility of the optical alignment system may have been proven by the optical mock-up, but the optical mock-up was not a reduction to practice of the proposed MHU–145/M trailer.”).” slip op. at 36
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“Here, we find that Petitioner has not met its burden to prove that one of ordinary skill in the art would have recognized that “the functional units of Georgiou operate asynchronously since they have different clocks.” Pet. 74 (citing Ex. 1002 ¶¶ 53–56, 211–219). Specifically, although Petitioner relies on Georgiou for teaching different clocks, Petitioner’s conclusory statement that such application would operate asynchronously requires gapfilling. Id. As Patent Owner points out, Georgiou discloses a clocking architecture in which “all domain clocks are derived from a shared master clock through predetermined rational dividers.” PO Resp. 49. Petitioner concedes during the oral hearing that, in systems such as Georgiou, each domain clock is set a fraction of a master clock, and thus, the various domain clocks are “possibly” synchronous with each other. Tr. 59:4–14 (JUDGE DANG: . . . would being fractions of the master, wouldn’t they be synchronized with each other? MR UHR: They may be, . . . the answer is possibly.”) Thus, we find Petitioner’s contention that a POSITA would have recognized that the functional units of Georgiou operate “asynchronously” lacks sufficient support in the record. We find the testimony of Dr. Baker insufficient to support Petitioner’s position. Ex. 1002 ¶¶ 53–56, 213, 215–219. In his declaration, Dr. Baker testified that he “provided several references . . . that explain operating domains asynchronous to one another while the domains operate synchronously.” Id. ¶¶ 215–219. However, although such references explain “globally asynchronous, local synchronous (GALS) systems” (id. ¶ 216), Dr. Baker does not explain why a POSITA “would have known that a functional unit of Georgiou also operates asynchronous with respect to at different frequencies.” Id. ¶ 217. Without evidentiary support, we are left with speculation and impermissible hindsight. See in Re Wagner, 379 F.2d 1011, 1017 (CCPA 1967). We decline to engage in speculation. See, e.g., In re Vaidyanathan, 381 F. App’x 985, 993 (Fed. Cir. 2010); In re Wallen, 565 F. App’x 867, 869 (Fed. Cir. 2014), both citing In re Zurko, 258 F.3d 1379, 1386 (Fed. Circ. 2001) ([T]he Board must point to some concrete evidence in the record in support of these findings.”). In sum, based on our review of the record, we find Petitioner’s showing is insufficient. Thus, based on the complete record presented, we determine that Petitioner has not persuasively shown that Georgiou teaches “operating the microprocessor such that each domain operates synchronously, while the domains operate asynchronously relative to one another,” as recited in claim 8.” slip op. at 28
- BurdenMixed
“of ordinary skill in the art would have recognized that “the functional units of Georgiou operate asynchronously since they have different clocks.” Pet. 74 (citing Ex. 1002 ¶¶ 53–56, 211–219). Specifically, although Petitioner relies on Georgiou for teaching different clocks, Petitioner’s conclusory statement that such application would operate asynchronously requires gapfilling. Id. As Patent Owner points out, Georgiou discloses a clocking architecture in which “all domain clocks are derived from a shared master clock through predetermined rational dividers.” PO Resp. 49. Petitioner concedes during the oral hearing that, in systems such as Georgiou, each domain clock is set a fraction of a master clock, and thus, the various domain clocks are “possibly” synchronous with each other. Tr. 59:4–14 (JUDGE DANG: . . . would being fractions of the master, wouldn’t they be synchronized with each other? MR UHR: They may be, . . . the answer is possibly.”) Thus, we find Petitioner’s contention that a POSITA would have recognized that the functional units of Georgiou operate “asynchronously” lacks sufficient support in the record. We find the testimony of Dr. Baker insufficient to support Petitioner’s position. Ex. 1002 ¶¶ 53–56, 213, 215–219. In his declaration, Dr. Baker testified that he “provided several references . . . that explain operating domains asynchronous to one another while the domains operate synchronously.” Id. ¶¶ 215–219. However, although such references explain “globally asynchronous, local synchronous (GALS) systems” (id. ¶ 216), Dr. Baker does not explain why a POSITA “would have known that a functional unit of Georgiou also operates asynchronous with respect to at different frequencies.” Id. ¶ 217. Without evidentiary support, we are left with speculation and impermissible hindsight. See in Re Wagner, 379 F.2d 1011, 1017 (CCPA 1967). We decline to engage in speculation. See, e.g., In re Vaidyanathan, 381 F. App’x 985, 993 (Fed. Cir. 2010); In re Wallen, 565 F. App’x 867, 869 (Fed. Cir. 2014), both citing In re Zurko, 258 F.3d 1379, 1386 (Fed. Circ. 2001) ([T]he Board must point to some concrete evidence in the record in support of these findings.”). In sum, based on our review of the record, we find Petitioner’s showing is insufficient. Thus, based on the complete record presented, we determine that Petitioner has not persuasively shown that Georgiou teaches “operating the microprocessor such that each domain operates synchronously, while the domains operate asynchronously relative to one another,” as recited in claim 8.” slip op. at 28
Patent outcomesUS 7,089,443 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,089,443 - Boe Technology Group Co., Ltd. v. Optronic Sciences, LLCAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,263,509 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 · GrahamPatents in suitUS 11,325,974 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,975 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,934,356 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 23, 2025 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–28 are unpatentable: claims 1, 2, 4–7, 9–12, 14–17, and 19–28 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious.
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 9
- Skill levelSkill level board ownOther
“In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Inst. Dec. 7. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also 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 cancers and the associated conditions and immunotherapy.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“holding is limited to anticipation of a claimed genus through disclosure of individual species, whereas the facts of this case involve the disclosure of a genus. PO Resp. 14. Because the facts before us, including the testimony of Patent Owner’s witness, indicate that one of ordinary skill in the art would have immediately understood that the third arm of the study described in the MSR includes patients with cancers recited in claim 1, including endometrial, gastric, and small-bowel cancers, we are persuaded that one of ordinary skill in the art would have understood that the MSR discloses species that fall within the scope of claim 1. Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 63; Ex. 1005, 4. We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1.6” slip op. at 29
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Regarding the dependent claims that Petitioner challenges only on obviousness grounds (claims 3, 8, 13, 18), Patent Owner must show a nexus between the claimed methods and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner does not direct us to evidence of a nexus to limitations recited in the dependent claims, for example to claims 3 and 13, which recite testing a biological sample that is a bodily fluid, claims 8 and 18, which recite testing that comprises assessing one or more markers selected from the group consisting of BAT-25, BAT-26, MONO-27, NR-21 and NR-24. Even if there is a nexus to the Patent Owner’s evidence of secondary considerations, the evidence addresses the methods of independent claims 1 and 11, not the limitations of the claims Petitioner challenges as being obvious. PO Resp. 55–83. Patent Owner directs us only to evidence regarding treating patients determined to have certain MSI-H cancers with pembrolizumab, which we determine to be anticipated by the MSR. Id. at 58. When evidence of a “secondary consideration is exclusively related to a single feature that is in the prior art,” our reviewing court has held the evidence is of no relevance to the obviousness inquiry. See Yita LLC v. MacNeil IP LLC, 69 F.4th 1356, 1363–65 (Fed. Cir. 2023), cert. denied, 144 S. Ct. 499 (2023) (distinguishing WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330–31 (Fed. Cir. 2016)); see also Ethicon Endo-Surgery, Inc. v. Covidien LP, 812 F.3d 1023, 1034 (Fed. Cir. 2016) (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”). In Yita, the prior art taught close-conformance of a floor tray with the walls of a vehicle foot well, which one of ordinary skill in the art would have had reason to use in combination with other prior-art teachings to arrive at the claimed invention. See Yita, 69 F.4th at 1359–61. The court held that because the asserted evidence of secondary consideration related exclusively to close-conformity, the evidence was not persuasive of non-obviousness, even though the claimed floor tray was coextensive with the product that produced the evidence. See id. at 1364–65 (“The coextensiveness inquiry bears only on the presumption of nexus; it does not decide the overall nexus question.”). Because Patent Owner directs us only to evidence that the methods recited in claims 1 and 11 produced evidence of secondary considerations, we are not persuaded that this evidence is persuasive of the non-obviousness of the specific methods recited in the dependent claims. For example, Patent Owner fails to direct us to evidence that a method of treating MSI-H colorectal cancer in a patient “wherein the biological sample is a body fluid from the patient,” as recited in claim 3, or “wherein the at least one marker comprises BAT-25, BAT-26, MONO-27, NR-21 or NR-24,” as recited in claim 8, demonstrated unexpected results or commercial success. Accordingly, having considered the evidence of record as a whole, we determine that Petitioner has demonstrated by a preponderance of the evidence that the methods of claims 3, 8, 13, and 18 would have been obvious. We are not persuaded to the contrary by Patent Owner’s arguments or evidence of second secondary considerations.” slip op. at 47
Patent outcomesUS 11,629,187 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,629,187
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