- Amgen, Inc. v. Bristol-Myers Squibb CompanyAdverse judgmentPTAB · Oct 1, 2025 · IPR2025-00603 · APJ Grace Karaffa Obermann · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner based on its statutory disclaimer of claims 1–18, then terminated the proceeding.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“In other words, the Smith & Nephew decision makes plain that entry of adverse judgment (as opposed to a denial without adverse judgment) is appropriate in situations where a patentee seeks to regain, through continued prosecution, subject matter that is patentably indistinct from previously surrendered subject matter. Id. That is precisely the situation at hand. Claim 43, pending in the ’822 continuation application, is of the same or broader scope than disclaimed claim 1 of the ’529 patent, as shown in Petitioner’s claim chart:” slip op. at 4
NonePatents in suitUS 11,332,529 - 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 - Seaspine Holdings Corporation v. Roger P. Jackson, M.D.Institution deniedPTAB · Aug 7, 2025 · IPR2025-00773 · APJ Mary C Hoffman · IPR · Institution
The Board denied institution because Patent Owner disclaimed claims 1–19, and declined to enter adverse judgment.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“challenged in the Petition and paid the requisite fee. See Ex. 2001; 37 C.F.R. § 1.321 (setting forth requirements for statutory disclaimer). Accordingly, we deny institution of the requested review. 37 C.F.R. § 42.107(e) (“No inter partes review will be instituted based on disclaimed claims.”); General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (denying institution based on pre-institution disclaimer of all challenged claims) (“General Electric”).” slip op. at 2
- Adverse judgmentAdverse judgmentDecided for patent owner
“interpreted Rule 42.73(b) as permitting the Board to enter adverse judgment when a patent owner disclaims all challenged claims prior to institution. See Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 1350 (Fed. Cir. 2018). But neither Arthrex nor Rule 42.73(b) require the entry of adverse judgment. Instead, under these circumstances, the Board has discretion to decide whether or not to enter adverse judgement. See, e.g., Bestway (USA), Inc. v. Intex Mktg., Ltd., PGR2024-00036, Paper 9, 6 (PTAB Oct. 28, 2024) (“Bestway”). Based on the facts of this case, we believe that efficient administration weighs against entry of adverse judgment. Thus, consistent with Rule 42.107(e) and General Electric, denial of institution is sufficient to dispose of this matter. See, e.g., Bestway at 8; Samsung Electronics Co., Ltd. v. Oura Health OY, IPR2024-00929, Paper 8, 3 (PTAB Dec. 9, 2024); Takeda Vaccines, Inc., v. Valneva Austria Gmbh, IPR2023-00354, Paper 7, 4 (PTAB June 9, 2023); Microsoft Corp. v. Litl, LLC, IPR2021-01011, Paper 11, 3 (PTAB Apr. 5, 2022); Cisco Sys., Inc. v. SecurityProfiling, LLC, IPR2021-01428, Paper 13, 7 (PTAB Mar. 14, 2021).” slip op. at 3
NonePatents in suitUS 11,399,873 - PTAB · Jul 30, 2025 · IPR2025-00247 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted review of claims 1–19 on all six asserted obviousness grounds, finding a reasonable likelihood that ResMed would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“(citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the briefing of record shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time the invention was made.10 See Graham, 383 U.S. at 17–18. Petitioner proposes that a person of ordinary skill in the art (sometimes referred to herein as “POSITA”) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Pet. 3–4 (citing Ex. 1003 (Kirkness Decl.) ¶ 44). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because the proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 10 For purposes of this Decision, we apply a priority date of November 4, 2005. See supra n.3. 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Beginning with the language of the claims themselves, Patent Owner does not point to anything that suggests this narrowing construction, and indeed we see nothing there that describes or requires a “quantitative determination[] or estimation[]” or requires use of “one or more algorithms.” See generally Ex. 1001, 23:6–26:59. Patent Owner provides only a single citation to the Specification, which discusses a “quantitative method for estimating or determining the severity of the subject’s sleeping disorder or symptoms” and states that “[v]arious algorithms known to those skilled in the art . . . quantify the level of severity of the subject’s sleeping disorder or symptoms.” See Ex. 1001, 19:61–20:23, cited at Prelim. Resp. 19. The cited portion of the Specification does not purport to expressly define the claim term “data of a severity of the symptoms of the subject.” See, e.g., Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (internal quotations omitted) (“To act as its own lexicographer, a patentee must clearly set forth a definition of the disputed claim term other than its plain and ordinary meaning.”). Patent Owner also does not presently demonstrate that we should read into the claim term “data of a severity of the symptoms of the subject” a requirement of a “quantitative determination[] or estimation[]” or use of an “algorithm[].” Prelim. Resp. 19. To be sure, the ’029 patent discloses embodiments that use known algorithms to “quantify the level of severity of the subject’s sleeping disorder or symptoms.” See, e.g., Ex. 1001, 20:11–19. But the Specification also appears to indicate that quantification is merely “preferable” (i.e., not required), and is merely one embodiment. See, e.g., id. at 19:8–12 (“The signals from the one or more sensors used in various embodiments of the present invention are preferably analyzed using a processor and software that can quantitatively estimate or determine the severity of the subject’s sleeping disorder or symptoms.”) (emphasis added), 4:51–59 (“Finally, in still another embodiment, the present invention includes a sleeping disorder treatment system comprising a device for diagnosing and creating a quantitative output of a level of severity of a subject’s sleeping disorder or symptoms . . . .”) (emphasis added). Elsewhere, the Specification more generally states that signals from sensors are “analyzed to determine the level of severity of the symptoms,” without specifying that such analysis must be “quantitative” or performed by an algorithm. See id. at 3:41–44. In view of such disclosures, Patent Owner does not persuade us on this record to adopt its narrowing claim construction. Indeed, our reviewing court has “repeatedly warned against confining the claims” to specific embodiments disclosed in the Specification. Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (en banc).” slip op. at 28
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Regarding Patent Owner’s argument that “a POSITA reading Kumar and Truitt would not be motivated to add that functionality to Truitt’s PAP device,” we find that this argument does not respond to Petitioner’s contentions. As discussed, Petitioner argues that Truitt’s PAP device already calculates severity or index data (see Pet. 17–21), and thus we do not presently understand Petitioner to be arguing that a person of ordinary skill in the art would have added this functionality to Truitt’s PAP device. Thus, Patent Owner’s argument that “a POSITA reading Kumar and Truitt would not be motivated to add that functionality to Truitt’s PAP device” is inapposite in view of Petitioner’s contentions. Even if the proposed combination requires adding an ability to calculate severity or index data, we are not persuaded by Patent Owner’s argument that a skilled artisan would have added it to Kumar, not Truitt, given that “Kumar’s computing device already has the necessary computational resources” to “receive multiple streams of data from the patient’s device and analyze the data before sending it to a remote site.” Prelim. Resp. 18, 17. This argument takes too narrow a view of Kumar. Kumar’s system “allows for the real-time streaming” of not only “raw” physiological data, but also of data that has already been “interpreted” or “processed.” Ex. 1008 (Kumar) ¶ 10. Accordingly, for purposes of institution, we find that Petitioner adequately demonstrates that “a POSITA would have been motivated to combine teachings of Truitt and Kumar such that the PAP device would wirelessly transmit to a patient’s cell phone data associated the patient’s treatment, including . . . the data of a severity of the sleep disorder symptoms of the subject.” Pet. 29–30 (emphasis added).” slip op. at 31
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,872,029 - PTAB · Jul 30, 2025 · IPR2025-00246 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on all asserted grounds against claims 15–29, finding a reasonable likelihood of success on the Toge–Kumar and Toge–Kumar–Norman obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the briefing of record shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 7
- Skill levelSkill level board ownDecided for petitioner
“understanding of a person of ordinary skill in the art at the time the invention was made.9 See Graham, 383 U.S. at 17–18. At this stage, the parties agree that a person of ordinary skill in the art (sometimes referred to herein as “POSITA”) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“We find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we 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))). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis below. Any final claim constructions will be based on the full trial record.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Motivation foundReasonable expectation foundInstituted
“At this stage, Petitioner has the better argument. Toge teaches that control unit 250 analyzes collected data (e.g., the flow rate) and calculates tidal volume. Ex. 1044 (Toge) ¶¶ 34–38. On this record, we agree with Petitioner that the calculated tidal volume is “a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy” because it represents, e.g., the “level of airway obstruction the patient experiences during the sleep apnea treatment using the PAP device.” Pet. 15. On this record, Patent Owner’s assertion that the tidal volume is a “breathing metric” instead of “a quantified level of severity data” is unavailing in view of Toge’s teaching that control unit 250 calculates the tidal volume, and its teaching that the tidal volume is used to assess the patient’s condition and determine whether system adjustments are needed. See id. at 15–16; Ex. 1044 (Toge) ¶ 39; Ex. 1003 (Kirkness Decl.) ¶ 157. In other words, on this record, the calculated tidal volume indicates severity because it is used to adjust the PAP system, e.g., in the case of decreasing tidal volume, a medical professional can change the airflow settings “to counter/treat the more severe level of airway obstruction observed from the decreasing tidal volume.” Ex. 1003 (Kirkness Decl.) ¶ 158.” slip op. at 20
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,857,333 - PTAB · Jul 25, 2025 · IPR2025-00237 · APJ Annette R Reimers · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 2, 5, 6, 11, 12, 17, 21, 23, 27, 28, or 30 were unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2024). An inter partes review may not be instituted “unless . . . 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). Upon consideration of the Petition and the evidence of record, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’879 patent is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“Patent Owner does not contest the level of ordinary skill in the art set forth in the Petition. Prelim. Resp. 19. Because Petitioner’s unopposed definition is consistent with the ’879 patent and the prior art of record, we adopt that definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“In particular, we agree with Patent Owner that Cantor does not teach or suggest contacting a ‘tissue section’ with its beads, let alone that its beads could be contacted with a tissue section to identify spatial location. Prelim. Resp. 36–48. In this case, we are persuaded by the testimony of Dr. Cantor, sole inventor of Cantor (Ex. 2002 ¶ 29), that Cantor’s nucleic acid samples are made in bulk from the extraction of nucleic acids from a biological sample and mixed together “to create the sample nucleic acid prior to mixing that with the solid phase nucleic acids to capture molecule(s) from the sample nucleic acid.” Id. at ¶ 36 (citing EX.1031 1:5–6). More specifically, according to Dr. Cantor, “[f]or bulk-analysis methods, nucleic acids are extracted from the different types of cells within a tissue sample without preserving their spatial distribution.” Id. at ¶ 19. Dr. Cantor further explains that in bulk-analysis methods, the mixture is analyzed to determine if a particular nucleic acid was present in the tissue sample or not. They cannot, however, determine where the molecule was in the tissue sample. As such, bulk-analysis techniques provide no information about spatial location of biological molecules in tissue samples. This is in contrast to spatial analysis methods such as those claimed in the ’879 patent which can determine both if a biological molecule was present in a tissue sample and where the molecule was in the tissue sample. Id. at ¶¶ 16–17. Although we recognize that Cantor discloses “providing the beads according to an (X,Y) array” (Pet. 24, 30–31 (citing to Dr. Puglisi, Ex. 1102 ¶¶ 133, 155, respectively), this disclosure makes no mention of using this array to map where the nucleic acids of Cantor came from relative to the original sample, let alone when that original sample is a tissue. See e.g. Ex. 1031, 17. The only mention of “tissue” made in Cantor is in reference to where the sample may be obtained, for example, “[t]he biological sample can be in any form, including without limitation a solid material such as a tissue.” Id. at 6. Cantor provides no teaching, however, regarding how to use a tissue sample with the probes and methods described in Cantor to identify where the target nucleic acids of Cantor were spatially located within the tissue section itself. See Ex. 2002 ¶¶ 142, 143 (Dr. Cantor testifying that (1) “a POSA would only be able to determine where on the array a target nucleic acid was captured, but not where in the original tissue section the nucleic acid came from,” because “all information about the spatial location of a target nucleic acid in a tissue sample is lost when the nucleic acid sample is prepared as Cantor teaches”; and (2) “Cantor [] does not teach or suggest contacting its solid supports (e.g. beads) with a tissue section and certainly not with its beads at known locations to obtain spatial information.”).” slip op. at 23
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“3. Discussion Petitioner challenges whether certain elements of independent claim 1 are supported by the’124 provisional and/or whether the ’879 patent’s priority chain is intact. Pet. 57–66. Having considered the parties’ positions and evidence of record, however, we agree with Patent Owner’s written description analysis, summarized above, and find that (1) the’124 provisional provides adequate written description support for each of the challenged claim elements; (2) the ’879 patent’s priority chain is intact; and (3) the ’879 patent is therefore entitled to the priority date of April 5, 2010. Consequently, Frisen is not prior art to the challenged claims. Because Frisen is not prior art, we do not specifically comment on its teachings, nor the factual assertions regarding its teachings provided by Petitioner or Patent Owner. 4. Conclusion For the foregoing reasons, we determine that Petitioner has not established a reasonable likelihood of showing that Frisen anticipates any of claims 1, 2, 5, 6, 11, 12, 17, 21, 23, 27, 28, and 30.” slip op. at 32
§ 102 anticipation§ 103 obviousnessPatents in suitUS 11,001,879 - PTAB · Jul 25, 2025 · IPR2025-00236 · APJ Annette R Reimers · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 2, 6, 7, 12, 13, 18, 20, 21, 23, 25, 26, or 30 were unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2024). An inter partes review may not be instituted “unless . . . 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). Upon consideration of the Petition and the evidence of record, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’468 patent is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had a doctorate degree (or equivalent) in bioengineering, genetics, genomics, chemistry, biochemistry, biophysics, molecular imaging or a related discipline with at least 2-4 years of academic, research, or industry experience in genomic technology. In the course of their training and experience, the POSA would have acquired a working knowledge of nucleic acid arrays, combinatorial chemistry techniques for making and using such arrays, nucleic acid sequencing and sample preparation techniques, such as barcoding, imaging methods for signal detection, as well as histopathology techniques for cell permeabilization and tissue handling. Pet. 13–14 (citing Ex. 1102 ¶¶ 30–32). Patent Owner does not contest the level of ordinary skill in the art set forth in the Petition. Prelim. Resp. 19. Because Petitioner’s unopposed definition is consistent with the ’468 patent and the prior art of record, we adopt that definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1354–55 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579–80 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 10
- Expert testimonyPatent owner expert creditedDecided for patent owner
“In particular, we agree with Patent Owner that Cantor does not teach or suggest contacting a ‘tissue section’ with its beads, let alone that its beads could be contacted with a tissue section to identify spatial location. Prelim. Resp. 37–44. In this case, we are persuaded by the testimony of Dr. Cantor, sole inventor of Cantor (Ex. 2002 ¶ 29), that Cantor’s nucleic acid samples are made in bulk from the extraction of nucleic acids from a biological sample and mixed together “to create the sample nucleic acid prior to mixing that with the solid phase nucleic acids to capture molecule(s) from the sample nucleic acid.” Id. at ¶ 36 (citing EX.1031 1:5–6). More specifically, according to Dr. Cantor, “[f]or bulk-analysis methods, nucleic acids are extracted from the different types of cells within a tissue sample without preserving their spatial distribution.” Id. at ¶ 19. Dr. Cantor further explains that in bulk-analysis methods, the mixture is analyzed to determine if a particular nucleic acid was present in the tissue sample or not. They cannot, however, determine where the molecule was in the tissue sample. As such, bulk-analysis techniques provide no information about spatial location of biological molecules in tissue samples. This is in contrast to spatial analysis methods such as those claimed in the ’468 patent which can determine both if a biological molecule was present in a tissue sample and where the molecule was in the tissue sample. Id. at ¶¶ 16–17. Although we recognize that Cantor discloses “providing the beads according to an (X,Y) array” (Pet. 25–26, 32–33 (citing to Dr. Puglisi, Ex. 1102 ¶¶ 133, 135, respectively), this disclosure makes no mention of using this array to map where the nucleic acids of Cantor came from relative to the original sample, let alone when that original sample is a tissue. See e.g. Ex. 1031, 17. The only mention of “tissue” made in Cantor is in reference to where the sample may be obtained, for example, “[t]he biological sample can be in any form, including without limitation a solid material such as a tissue.” Id. at 6. Cantor provides no teaching, however, regarding how to use a tissue sample with the probes and methods described in Cantor to identify where the target nucleic acids of Cantor were spatially located within the tissue section itself. See Ex. 2002 ¶¶ 142, 143 (Dr. Cantor testifying that (1) “a POSA would only be able to determine where on the array a target nucleic acid was captured, but not where in the original tissue section the nucleic acid came from,” because “all information about the spatial location of a target nucleic acid in a tissue sample is lost when the nucleic acid sample is prepared as Cantor teaches”; and (2) “Cantor [] does not teach or suggest contacting its solid supports (e.g. beads) with a tissue section and certainly not with its beads at known locations to obtain spatial information.”).” slip op. at 23
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentable
“In particular, we agree with Patent Owner that Cantor does not teach or suggest contacting a ‘tissue section’ with its beads, let alone that its beads could be contacted with a tissue section to identify spatial location. Prelim. Resp. 37–44. In this case, we are persuaded by the testimony of Dr. Cantor, sole inventor of Cantor (Ex. 2002 ¶ 29), that Cantor’s nucleic acid samples are made in bulk from the extraction of nucleic acids from a biological sample and mixed together “to create the sample nucleic acid prior to mixing that with the solid phase nucleic acids to capture molecule(s) from the sample nucleic acid.” Id. at ¶ 36 (citing EX.1031 1:5–6). More specifically, according to Dr. Cantor, “[f]or bulk-analysis methods, nucleic acids are extracted from the different types of cells within a tissue sample without preserving their spatial distribution.” Id. at ¶ 19. Dr. Cantor further explains that in bulk-analysis methods, the mixture is analyzed to determine if a particular nucleic acid was present in the tissue sample or not. They cannot, however, determine where the molecule was in the tissue sample. As such, bulk-analysis techniques provide no information about spatial location of biological molecules in tissue samples. This is in contrast to spatial analysis methods such as those claimed in the ’468 patent which can determine both if a biological molecule was present in a tissue sample and where the molecule was in the tissue sample. Id. at ¶¶ 16–17. Although we recognize that Cantor discloses “providing the beads according to an (X,Y) array” (Pet. 25–26, 32–33 (citing to Dr. Puglisi, Ex. 1102 ¶¶ 133, 135, respectively), this disclosure makes no mention of using this array to map where the nucleic acids of Cantor came from relative to the original sample, let alone when that original sample is a tissue. See e.g. Ex. 1031, 17. The only mention of “tissue” made in Cantor is in reference to where the sample may be obtained, for example, “[t]he biological sample can be in any form, including without limitation a solid material such as a tissue.” Id. at 6. Cantor provides no teaching, however, regarding how to use a tissue sample with the probes and methods described in Cantor to identify where the target nucleic acids of Cantor were spatially located within the tissue section itself. See Ex. 2002 ¶¶ 142, 143 (Dr. Cantor testifying that (1) “a POSA would only be able to determine where on the array a target nucleic acid was captured, but not where in the original tissue section the nucleic acid came from,” because “all information about the spatial location of a target nucleic acid in a tissue sample is lost when the nucleic acid sample is prepared as Cantor teaches”; and (2) “Cantor [] does not teach or suggest contacting its solid supports (e.g. beads) with a tissue section and certainly not with its beads at known locations to obtain spatial information.”).” slip op. at 23
§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,662,468 - Neurent Medical Inc. / Neurent Medical Ltd. v. The Foundry, LLCAll claims unpatentablePTAB · Jul 21, 2025 · IPR2024-00669 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–8 and 11 are unpatentable as obvious over Makower, Fang, and Edwards, with claim 4 also obvious over those references and Stern; the Board did not reach Grounds 1–4.
RulingsFinal written decision- Skill levelSkill level board ownOther
“Based on the record before us, including the types of problems and solutions described in the ’077 patent and the cited prior art, we find a POSA would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in biomedical engineering or a related discipline, (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices that deliver energy to tissue, and 3) knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. Less work experience may be compensated by a higher level of education, and vice versa. 11 Patent Owner suggests a POSA’s ability to “learn about” the nasal anatomy invokes the wrong standard because a POSA “must have the necessary background at the time of the invention.” PO Sur-reply 27. We agree in part with Patent Owner; the hypothetical POSA is presumed to possess the requisite skill at the time of the invention. Nevertheless, as it concerns an engineer with extensive experience designing and developing RF ablation devices (like Dr. Martin), we see no basis to conclude that such person may not become familiar with the features of the nose through review of the literature and/or consultation with clinicians. Ex. 1098 ¶ 44 (testifying a person with device design experience could learn about the relevant nasal anatomy and apply their skill to problems or solutions for that area by reviewing the relevant literature). Moreover, that Dr. Martin may not have had personal experience designing devices for the nose prior to 2006 does not mean that he cannot testify from a POSA’s perspective. Osseo Imaging, LLC v. Planmeca USA, Inc., 116 F.4th 1335, 1341 (Fed. Cir. 2024) (“An expert need not have acquired the skill level prior to the time of the invention to be able to testify from the vantage point of a person of ordinary skill in the art” because “an expert can acquire the necessary skill level later and develop an understanding of what a [POSA] knew at the time of the invention”) (emphasis omitted). Petitioner that the ’077 patent discloses delivering neurotoxins to any target, and not just the nose, the claims of the ’077 patent are directed to methods of treating a nasal condition by delivering energy to the nasal cavity. Pet. Reply 32. Thus, to fill a gap between Petitioner’s POSA definition and the scope of the challenged claims, we add to Petitioner’s definition the requirement for knowledge and experience in treating nasal conditions, or access to a person with that knowledge and experience. We additionally add that a POSA’s educational background may include a bachelor of science degree in biomedical engineering or related discipline to reflect the nature of the field of invention. Nonetheless, we also note that our analysis and conclusions herein would not change even under Petitioner’s proposed skill level for a POSA. We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’077 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. We also disagree that Dr. Martin’s testimony should be discounted for a lack of first-hand experience designing RF ablation devices specific for the nose (which experience Patent Owner’s engineer expert also lacks). Id. As Dr. Martin’s testimony concerns certain issues in dispute (i.e., use of bipolar electrodes), we find Dr. Martin is qualified and his testimony helpful in resolving those disputes. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (explaining And, even if there may be gaps in Dr. Martin’s experience or knowledge about the nasal anatomy, such gaps are filled by Dr. Bu-Saba’s extensive clinical expertise and testimony of record. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba or Dr. Martin; we give their testimony appropriate weight in reaching our conclusions here.” slip op. at 15
- Expert testimonyPetitioner expert creditedOther
“We do not agree with Patent Owner that prior experience designing or developing nasal medical devices is required for a POSA. PO Resp. 19–20. A definition inclusive of the clinical use, design, development, and/or testing of nasal medical devices that deliver energy to tissue is consistent with the skill level reflected in the disclosures of the ’077 patent and prior art. Consequently, we disagree with Patent Owner that Dr. Bu-Saba fails to qualify as a POSA because he lacks experience specific to designing medical devices. PO Resp. 19 n.4. We also disagree that Dr. Martin’s testimony should be discounted for a lack of first-hand experience designing RF ablation devices specific for the nose (which experience Patent Owner’s engineer expert also lacks). Id. As Dr. Martin’s testimony concerns certain issues in dispute (i.e., use of bipolar electrodes), we find Dr. Martin is qualified and his testimony helpful in resolving those disputes. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (explaining And, even if there may be gaps in Dr. Martin’s experience or knowledge about the nasal anatomy, such gaps are filled by Dr. Bu-Saba’s extensive clinical expertise and testimony of record. Accordingly, we do not agree with Patent Owner that we should discount the testimony of Dr. Bu-Saba or Dr. Martin; we give their testimony appropriate weight in reaching our conclusions here.” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims’ language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only to the extent needed to resolve the dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019); U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (holding claim construction is for “resolution of disputed meanings”). Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner responds that “the Board need not construe any terms to determine Petitioners have failed to carry their burden in this proceeding.” PO Resp. 20. On the record before us, we conclude that the claims need not be expressly construed to resolve the dispute before us. Insofar as the parties dispute the mapping of the prior art to dependent claims 4 and 7, we address that dispute below including, to the extent necessary, any implicit disagreement about the subject matter encompassed by those claims.” slip op. at 17
- BurdenFwd all claims unpatentableUnpatentable
“For all the reasons above, we determine that the evidence supports Petitioner’s contention that a POSA would have reasonably expected success in combining the prior art to arrive at the subject matter of claim 1.” slip op. at 44
Patent outcomesUS 11,679,077 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,679,077
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.