- PTAB · Nov 3, 2025 · IPR2025-00827 · APJ Barry L Grossman · IPR · Institution
The Board instituted IPR on claims 1–5, 7–14, 16–19, 22–26, and 28–32, finding a reasonable likelihood that Renisch anticipates at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have considered Patent Owner’s arguments, but, on this record, are not persuaded. We recognize that Dr. Sonka provides a different opinion than Petitioner and Dr. Rosen. Dr. Sonka testifies that in his opinion “the distinctions between Renisch and claim 1 go beyond terminology.” Ex. 2014 ¶ 79. At this stage, in the absence of a full record, we need not record, it appears that Renisch discloses the elements of limitation [1(c)] at paragraphs 26–31, where it discloses obtaining a scanned 3D image of a fuller anatomy, i.e., a segmentation map, and then using a segmentation unit (76) to define the boundaries of anatomical structures of interest within that fuller anatomy, i.e., creating a plurality of segmentation masks, using a library, models, clustering, edge detection, region growing, neural networks, and/or an atlas of normal anatomical structures, and then identifying hot spots of interest within those anatomical structures of interest, and identifying organs with lesions and those without. Ex. 1005 ¶¶ 26–31. Based on the record before us and the specific disclosures in Renisch, as discussed in this Decision, we determine that Petitioner has met the “reasonable likelihood” standard necessary to institute an inter partes review proceeding. Although we address only Ground A and claims 1 and 10 herein for the purposes of institution, as noted above, we will address all asserted grounds and challenged claims in any final decision.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We do not perceive a need to construe any claim limitation at this time. This, however, does not preclude the parties from arguing proposed constructions of the claims during trial. Indeed, the parties are hereby given notice that any disputed claim construction, in general, should be addressed at trial and, if so, should be addressed clearly in a designated section of briefing rather than relegated to arguments on the merits of patentability. Claim construction, if necessary, will be determined at the close of the evidentiary record and after any hearing. slip op. at 15
- BurdenDecided for petitioner
“Compliance with the Particularity Requirements of 35 U.S.C. § 312(a)(3) Patent Owner asserts that the Petition fails to meet the particularity requirements of 35 U.S.C. § 312(a)(3). Prelim. Resp. 18–26. According to Patent Owner, “Petitioner’s excessive internal cross-referencing impermissibly forces the Board and Patent Owner to piece together scattered portions of the Petition (and exhibits).” Id. at 26. Patent Owner concludes that “the Petition fails to adequately map the references to the claim elements with particularity.” Id. We disagree. Using claims 1 and 10 as an example, Petitioner asserts: Claim 10 recites a “system for automatically processing 3D images” that is substantively identical to the “method for automatically processing 3D images” recited in claim 1, addressed above. Whereas claim 1 (the method claim) recites a series of steps, each performed “by a processor,” claim 10 (the system claim) recites a “processor” with stored instructions that perform the same steps recited in claim 1. Similarly, dependent claims 11–14, 16, and 26 are substantively identical to dependent claims 2–5, 7, and 19. Pet. 41–42. Claims 1 and 10 contain similar elements and limitations. Petitioner’s reference, for example, in the Petition’s analysis of claim 10, back to the analysis of claim 1 concerning nearly identical elements and limitations (id. at 42) is a matter of efficiency and is sufficiently clear for us to determine the basis for Petitioner’s challenges. We determine that the Petition does not violate the statutory requirement for particularity.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We have considered Patent Owner’s arguments, but, on this record, are not persuaded. We recognize that Dr. Sonka provides a different opinion than Petitioner and Dr. Rosen. Dr. Sonka testifies that in his opinion “the distinctions between Renisch and claim 1 go beyond terminology.” Ex. 2014 ¶ 79. At this stage, in the absence of a full record, we need not record, it appears that Renisch discloses the elements of limitation [1(c)] at paragraphs 26–31, where it discloses obtaining a scanned 3D image of a fuller anatomy, i.e., a segmentation map, and then using a segmentation unit (76) to define the boundaries of anatomical structures of interest within that fuller anatomy, i.e., creating a plurality of segmentation masks, using a library, models, clustering, edge detection, region growing, neural networks, and/or an atlas of normal anatomical structures, and then identifying hot spots of interest within those anatomical structures of interest, and identifying organs with lesions and those without. Ex. 1005 ¶¶ 26–31. Based on the record before us and the specific disclosures in Renisch, as discussed in this Decision, we determine that Petitioner has met the “reasonable likelihood” standard necessary to institute an inter partes review proceeding. Although we address only Ground A and claims 1 and 10 herein for the purposes of institution, as noted above, we will address all asserted grounds and challenged claims in any final decision.” slip op. at 20
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 11,941,817 - 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 - Shenzhen Root Technology Co., Ltd. v. Willow Blossom Holdco Limited And Willow Innovations, Inc.InstitutedPTAB · Oct 14, 2025 · IPR2025-00554 · APJ Barry L Grossman · IPR · Institution
The Board instituted review of claims 17–19 and 21–33 on every asserted ground, finding a reasonable likelihood that claim 17 is unpatentable over Furrer alone and Furrer with Alvarez.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“After considering the Petition and the evidence of record, based on the analysis in this Decision, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of the challenged claims is unpatentable. Accordingly, we institute an inter partes review of all challenged claims and on all grounds asserted in the Petition. PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (stating that a decision to institute is “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art would have had “bachelor’s degree in mechanical engineering or a similar field and at least two years of experience designing human breast pump equipment. More education could substitute for experience and vice versa.” Pet. 3–4 (citing Ex. 1003 ¶¶ 30–33). Mr. Bauer’s Declaration testimony states he considered some of the factors listed above. Ex. 1003 ¶ 32. Mr. Bauer testifies that based on his background and experience, in his opinion, the level of ordinary skill is as stated by Petitioner. Id. at 33. For purposes of this Decision, based on the prior art, the sophistication of the disclosed technology in the ’381 patent, and Mr. Bauer’s undisputed testimony, we adopt Petitioner’s definition of the level of ordinary skill.6” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that “[a]ll claim terms should be construed according to the Phillips standard,” and that “no formal claim constructions are necessary for purposes of resolving controversies in this proceeding. Pet. 3. We agree. Given the lack of dispute on this record, we do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Mr. Bauer further testifies: For electric-powered breast pumps, the only two options for providing electricity to the pump was either via a wire plugged into an outlet or via a battery, as would have been well-known to a POSITA. It would have been obvious for a POSITA to utilize a battery as the power source for Furrer’s pump as it was one of the two available options and would have provided known benefits. Ex. 1003 ¶ 93. As to why this a person of ordinary skill would have chosen the option of a battery powered breast pump, Mr. Bauer testifies that: Selection of battery power for Furrer’s pump would have beneficially provided a portable system that was usable during travel. Additionally, such a configuration would have allowed the user to move freely about a room, or be positioned in a location within a room without being tethered to a wall plug, allowing the user to, for example, sit or lay in the most convenient location while using the system without having to worry about being close to an outlet. Such mobility provided by selecting battery power for Furrer’s pump would have particularly aligned with Furrer’s suggestion for a ‘hands-free’ and discrete solution. Id. (internal citations omitted); see also Ex. 1003 ¶¶ 138, 143, 145 (further discussing the motivation to combine Furrer and Alvarez in the context of Ground 1B). Based on the record before us, without any evidence or argument to the contrary, we determine that Petitioner shows sufficiently for purposes of trial institution that Furrer, alone or in combination with Alvarez, discloses the claimed control unit comprising a battery, and a pump.” slip op. at 23
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,806,454 - PTAB · Oct 8, 2025 · IPR2025-00629 · APJ Scott C Moore · IPR · Institution
The Board instituted IPR of claims 1–20 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Beard and Laufer.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We may institute an inter partes review when “the information presented in the petition . . . 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). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of one or more claims of the ’711 Patent. We, therefore, institute inter partes review of claims 1–20 on the grounds identified in the Petition. B.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that one of ordinary skill in the art would have had the following qualifications: [E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace or avionics fields, or (2) at least four years of experience in any of the above industries. 1 The Leahy-Smith America Invents Act (“AIA”) included revisions to 35 U.S.C. §§ 102 and 103 that became effective on March 16, 2013. Because the applications from which the ’711 Patent claims priority were all filed after this date, the post-AIA version of §103 applies. See Ex. 1001, codes (60), (63). 2 U.S. Patent No. 9,769,387 B1, iss. Sept. 19, 2017 (Ex. 1009). 3 U.S. Patent App. Pub. No. 2017/0059692 A1, pub. Mar. 2, 2017 (Ex. 1010). 4 U.S. Patent App. Pub. No. 2012/0106800 A1, pub. May 3, 2012 (Ex. 1021). 5 U.S. Patent App. Pub. No. 2017/0161911 A1, pub. June 8, 2017 (Ex. 1007). 6 U.S. Patent App. Pub. No. 2013/0301905 A1, pub. Nov. 14, 2013 (Ex. 1024). 7 U.S. Patent App. Pub. No. 2012/0004844 A1, pub. Jan. 5, 2012 (Ex. 1025). 8 PCT App. Pub. No. WO 2017/123477 A1, pub. July 20, 2017 (Ex. 1022). 9 U.S. Patent App. Pub. No. 2017/0160751 A1, pub. June 8, 2017 (Ex. 1005). Pet. 8 (citing Ex. 1003 ¶¶ 50–54). Patent Owner does not presently dispute Petitioner’s proposed formulation. See generally Prelim. Resp. For purposes of this Decision, we adopt and apply Petitioner’s formulation regarding the level of ordinary skill in the art because it is (1) consistent with the ’711 Patent and the asserted prior art; and (2) it is supported by the testimony of Dr. Singhose. B.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“But the Detecting Limitations of claims 1, 19, and 20, merely require that a target be “detected.” The Detecting Limitations do not require that target detection be performed “aboard the reference UAV,” and claim 19 does not recite or require “machine learning.” Moreover, the Specification makes clear that the claims should not be limited to aspects of the disclosed embodiments, as Patent Owner proposes to do here. See, e.g., Ex. 1001, 2:56–59 (“The invention is described in connection with such embodiments, but the invention is not limited to any embodiment. The scope of the invention is limited only by the claims . . . .”) Patent Owner additionally fails to cite any lexicographic definition or clear and unambiguous disclaimer of claim scope sufficient to limit the claims in the manner it proposes. We, thus, are not persuaded that the Detecting Limitations require “applying aboard the reference UAV a machine learning model to the capture image for: (i) identifying a target in the captured image.”” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Priority Date of the Challenged Claims Petitioner contends that claims 1–20 of the ’711 Patent “should not have priority to the October 9, 2016 filing date of U.S. provisional [patent] application 62/405,972 due to a lack of written description support.” Pet. 3. Petitioner thus “assumes” a priority date of October 1, 2017 (the filing date of U.S. Provisional Patent Application No. 62/556,449) for purposes of this proceeding. Id. at n.2; see also Ex. 1003, code (60). Patent Owner does not presently dispute Petitioner’s contention that the ’711 Patent is not entitled to a priority date earlier than October 1, 2017. See generally Prelim. Resp. For purposes of this decision, we accept Petitioner’s undisputed contention that the ’711 Patent is not entitled to a priority date prior to 10 Any determination, no matter how designated in this Institution Decision (except our ultimate decision to institute), is preliminary and non-binding. Our Final Written Decision, based on a fully developed record of arguments and evidence, will state our binding determinations, findings, and conclusions. If a party disagrees with this preliminary construction, or any other determination set forth in this Institution Decision, that party should present its arguments at trial. The parties are reminded that any arguments not made during trial will be considered waived. Patent Owner is further reminded that arguments in the Preliminary Response are not preserved and will be considered waived at trial unless those arguments are re-raised in the Patent Owner Response. The parties are additionally reminded that arguments raised in subsequent briefing must be set forth in full in the briefs themselves, and may not be incorporated by reference from prior filings such as the Preliminary Response. See 37 C.F.R. § 42.6(a)(3). October 1, 2017.11 Accordingly, Petitioner has made a sufficient showing that all of the cited references qualify as prior art. See Pet. 4–6. D.” slip op. at 11
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,514,711 - PTAB · Oct 8, 2025 · IPR2025-00530 · APJ Scott C Moore · IPR · Institution
Instituted review of claims 1–9 on all petition grounds after finding a reasonable likelihood that claim 1 is obvious over Whitmarsh.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the petition . . . 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). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of at least one of the challenged claims. We, therefore, institute inter partes review of claims 1–9 on the grounds asserted in the Petition. B.” slip op. at 2
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner
“permission module,” as used in claim 1, has “a well understood structural meaning in the computer technology field.” 792 F.3d at 1350. Rather, the limitation in question is “drafted in the same format as a traditional means-plus-function limitation, and merely replaces the term ‘means’ with ‘nonce’ word ‘module,’ thereby connoting a generic ‘black box’ for performing the recited computer-implemented functions.” Id. And, while claim 1 recites the “outputs” of the permission module (i.e., a determination regarding the permissions of an aerial system), “the claim does not describe how the [permission module] interacts with other components in the [discrimination system] in a way that might inform the structural character of the limitation- in-question or otherwise impart structure to the [permission module] as recited in the claim.” Id. at 1351. We also reviewed the Specification, and we agree with Petitioner that the Specification identifies the following structure as corresponding to the claimed permission module: “storage on-board the disruption module 105, storage on-board the identification receiver 102, a remote computing system connected to the disruption module…, or [] any other suitable computing system.” See Pet. 12; Ex. 1001, 9:64–10:4. slip op. at 7
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableInstituted
“from nearby UAVs wireless communications that include information or signatures unique to the UAVs, such as a MAC [media access control] address of the UAV, that is used to identify the transmitting UAV.” Pet. 16– 18 (citing Ex. 1005 ¶¶ 20, 27; Ex. 1006 ¶¶ 8, 10, 13, 15–17; Ex. 1003 ¶¶ 117–118). For example, Petitioner cites Whitmarsh’s teachings that “[a]ll drones have a unique identifier, such as a media access control (MAC) address, that can be determined or read by the DDS [drone defense system] and can be used to identify the drone.” Id. at 16 (quoting Ex. 1006 ¶ 13). Based on these teachings, Petitioner submits that the signal received from the UAVs includes an aerial system identifier signal unique to the aerial system. Id. at 17–18 (citing Ex. 1005 ¶ 27; Ex. 1006 ¶ 13).” slip op. at 10
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,249,199 - PTAB · Oct 8, 2025 · IPR2025-00525 · APJ Scott C Moore · IPR · Institution
The Board instituted review of claim 21 on all asserted grounds after finding a reasonable likelihood it is obvious over Beard.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the petition . . . 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). If we institute an inter partes review, the trial must encompass all claims and grounds identified in the Petition. 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”). For the reasons set forth below, we conclude that there is a reasonable likelihood that Petitioner will prevail in establishing the unpatentability of claim 21, the sole challenged claim. We, therefore, institute inter partes review of claim 21 on the grounds asserted in the Petition. B.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“[E]ither (1) a Bachelor of Science in Mechanical Engineering, Electrical Engineering, Aerospace engineering, or an equivalent field, as well as at least 2 years of academic or industry experience in the aerospace, avionics, telecommunications, or electronic device manufacturing industry, or (2) at least four years of industry experience in any of the above industries. Pet. 21 (citing Ex. 1003 ¶ 47). Patent Owner does not presently dispute Petitioner’s proposed formulation. See generally Prelim. Resp. For 3 U.S. Patent App. Pub. No. US 2016/0253907 A1, published Sept. 1, 2016 (Ex. 1010). 4 PCT Pub. No. WO 2016/078093 A1, published May 26, 2016 (Ex. 1011). 5 PCT Pub. No. WO 2016/154949 A1, published Oct. 6, 2016 (Ex. 1012). 6 U.S. Pat. App. Pub. No. US 2016/0127890 A1, published May 5, 2016 (Ex. 1013). 7 PCT Pub. No. WO 2015/043123 A1, published Apr. 2, 2015 (Ex. 1014). purposes of this Decision, we adopt and apply Petitioner’s formulation regarding the level of ordinary skill in the art because it is (1) consistent with the ’959 Patent and the asserted prior art; and (2) it is supported by the testimony of Dr. Chowdhary. B.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“But before describing the embodiments cited by Patent Owner, the Specification plainly states: “Any terms not expressly defined herein have their conventional meaning as commonly understood by those having skill in the relevant art(s).” Ex. 1001, 4:64–67. Thus, the Specification itself cautions against construing the claim terms such as “secure identifier” as limited to the scope of the disclosed embodiments. Here, Patent Owner has not cited any express definition of “secure identifier,” or identified any explicit disclaimer of claim scope that might justify narrowing the scope of this claim term to specific embodiments disclosed in the Specification. In the absence of such a definition or disclaimer, we are not persuaded that the scope of the claim term “secure identifier” should be limited to specific aspects of the preferred embodiments cited by Patent Owner. See Prelim. Resp. 7–14. On this record, and at this stage of the proceeding, we decline to adopt Patent Owner’s proposed construction and preliminarily construe “secure identifier” as “a credential that can be used to securely verify the identity of a device, such as an airborne object or ground-based transmitter.”8” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“’071 Application lack adequate written description support for the “secure identifier” claim limitation. For a patent claim to be entitled to the priority date of an earlier-filed application, the earlier application must provide complete written description support for the claim as required by 35 U.S.C. § 112(a). L.A. Biomedical Rsch. Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“L.A. Biomed”). To satisfy this requirement, the written description must “reasonably convey” to a person of ordinary skill in the art that the inventor had possession on the claimed priority date of each limitation of the later-claimed subject matter. L.A. Biomed, 849 F.3d at 1057. It is not enough that an earlier application’s disclosure “renders the later-claimed invention obvious;” as “the disclosure must describe the claimed invention with all its limitations.” L.A. Biomed, 849 F.3d at 1057. On this record, we agree with Petitioner that the ’153 Provisional and ’071 Application lack adequate written description support for the “secure identifier” limitation of claim 21. We have preliminarily construed “secure identifier” as “a credential that can be used to securely verify the identity of a device, such as an airborne object or ground-based transmitter.” See supra § II.B. As discussed above, the Specification of the ’959 Patent does not use the term “secure identifier,” but the Specification contains extensive discussion of the need for an identification credential that is secure (e.g., difficult for a bad actor to clone or impersonate). See, e.g., Ex. 1001, 1:56– 65 (discussing the need for a system that is difficult to “clone”), 10:20–49 (discussing the need “trust” between a drone and ground-based equipment, and the need for a way to verifying the drone’s credentials), 11:5–12:62 (disclosing the use of encryption and a rotating SSID to generate a secure identifier for a drone). None of the portions of the Specification cited above is present in the ’153 Provisional or the ’071 Application. See generally Ex. 1006, 1007. The ’153 Provisional and ’071 Application discuss the need for identifiers for low-altitude aircraft (see, e.g., Ex. 1006, 2; Ex. 1007, 9), but there is no discussion of any need for an identification credential to be secure or resistant to cloning or impersonation. See generally Ex. 1006, 1007. The ’153 Provisional and ’071 Application do not disclose the use of encryption, SSIDs (much less rotating SSIDs), or any other technologies for the purpose of verifying the authenticity of an identification credential. See generally id. Based on our review of the ’153 Provisional and ’071 Application, we preliminarily conclude that neither of these applications would have reasonably conveyed to a person of ordinary skill in the art that the inventor then had possession of the concept of the “secure identifier” that was later claimed in the ’959 Patent.” slip op. at 12
Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · GrahamPatents in suitUS 10,713,959 - Anthony Inc. v. Controltec, LLCInstitutedPTAB · Sep 30, 2025 · IPR2025-00636 · APJ Barry L Grossman · IPR · Institution
The Board instituted IPR on claims 1–20 and all asserted grounds, finding a reasonable likelihood of success on claim 8 over Carter.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“partes review may not be instituted “unless . . . 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). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“On July 16, 2025, the Acting Director issued her decision, which denied Patent Owner’s request for discretionary denial and referred this case to the Board. Paper 9, 3. The Decision stated “Petitioner provides persuasive reasoning, supported by evidence, that the Office erred in a manner material to the patentability of the challenged patents during patent examination, and, accordingly, discretionary denial under 35 U.S.C. § 325(d) is not appropriate.” Id. The Decision also stated “it is an appropriate use of Office resources to review the potential error.” Id. As stated in the Acting Director’s decision, “the Petitions [in IPR2025-00559; 00636] are referred to the Board to handle the cases in the normal course, including by issuing a decision on institution addressing the merits and other nondiscretionary considerations, as appropriate.” Id. (emphasis added). Thus, the scope of our delegated authority only extends to “the merits and other nondiscretionary considerations.” Accordingly, we do not address the discretionary denial issue raised in the Petition and in the Patent Owner’s Preliminary Response.” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, based on the prior art, the sophistication of the disclosed technology in the ’847 patent, and Dr. Henze’s undisputed testimony, we adopt Petitioner’s definition of the level of ordinary skill.8” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We do not perceive the need to construe any claim limitation at this time. Our conclusion concerning instituting an inter partes review would be unaffected by a determination that the preambles of the claims are limiting. Accordingly, for this initial Decision to institute an inter partes review, the words “display” or “frame,” and the term “display case” will be given their ordinary and customary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 7,421,847 - 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 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 23, 2025 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–36 are unpatentable: claims 1–2, 4–8, 11–12, 14–18, and 21–36 as anticipated, and claims 3, 9, 10, 13, 19, and 20 as obvious.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided 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 colorectal cancer to determine that the patient’s colorectal 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 colorectal 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 petitioner adoptedDecided for petitioner
“The ’287 patent claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. See Ex. 1001, 24:42–52; Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Dec. 7– 8. 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 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). We credit Dr. Neugut’s and Dr. Oberstein’s testimony about what one of ordinary skill in the art would have understood after reviewing the MSR. slip op. at 34
Patent outcomesUS 11,649,287 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,649,287 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 19, 2025 · IPR2024-00650 · APJ Deborah Katz · IPR · Final written decision
Claims 1–38 are unpatentable: claims 1, 2, 4–7, 11–17, 19–22, and 26–38 are anticipated by the MSR; the remaining claims are obvious over the MSR and cited references.
RulingsFinal written decision- 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 be 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. (See 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. (See PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 91–99).) Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’491 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 discloses testing pembrolizumab to treat human patients. (See Ex. 1001, 25:36–52, 26:24–41, Ex. 1005; see Decision 8–9.) Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. 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 ’491 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. C. Claim Construction” slip op. at 8
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Dr. Lonberg, Patent Owner’s witness, does not dispute any of Dr. Neugut’s or Dr. Oberstein’s testimony, but asserts only that Dr. Neugut’s testimony relies only on what was generally done, not on what is expressly disclosed in the MSR. (See Ex. 2072 ¶¶ 105–107.) On cross-examination, Dr. Lonberg agreed with Dr. Oberstein that patients who had received prior cancer therapy were not excluded from the study described in the MSR. (See Ex. 1245, 57:5–58:2, 40:5–14, 49:2–12.) Thus, after considering the evidence cited by each party, we find Dr. Neugut’s and Dr. Oberstein’s testimony to be the most directly relevant and persuasive about what one of ordinary skill in the art would have understood from the MSR itself. We are also persuaded by the lack of a specific contradiction regarding the understanding of one of ordinarily skill in the art by Dr. Lonberg. Even if some patients who had been previously treated with specific drugs were excluded from the study described in the MSR, we are persuaded that one of ordinary skill in the art would have understood the MSR as including other patients who have been treated with a prior cancer therapy drug. We are persuaded that Petitioner has met its burden of proving whether a skilled artisan would reasonably understand or infer that the limitations of claims 13, 28, 32, and 36 were disclosed in the MSR. Petitioner demonstrates what one of ordinary skill in the art would have understood from the MSR, not what it inherently discloses. (Contra PO Resp. 19–22.)” slip op. at 38
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Patent Owner argues that the “in response to” limitation of claim 1 describes administering the claimed treatment only to patients determined to have an MSI-H tumor. (See PO Resp. 6.) But neither claim 1 nor claim 16 includes a limitation excluding the treatment of any patient, such as specifically excluding treatment of any patient who has a tumor that is not MSI-H or dMMR. Neither claim 1 nor claim 16 recites any language differentiating between patients or identifying a patient population to be excluded from treatment. Instead, claims 1 and 16 provide that if the colorectal cancer patient is tested and the cancer is determined to be MSI-H or dMMR, the patient is treated with a therapeutically effective amount of pembrolizumab. We note that the methods of claims 1 and 16 use the open-ended transitional phrase “comprising” that is generally interpreted to not exclude additional, unrecited elements. See Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language that means that the named elements are essential, but that other elements may be added and still form a construct within the scope of the claim.”). The use of the open-ended transitional phrase “comprising” in claims 1 and 16 further suggests to us that any additional steps taken in conjunction with expressly recited method steps, such as the treatment of patients who are not MSI-H or dMMR, are not excluded from the scope of the claim.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“discloses species that fall within the scope of claim 1. (See Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 67; 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. d) Element [1.3]: “thereby determining that the patient’s cancer is” slip op. at 26
Patent outcomesUS 11,634,491 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.