- PTAB · Sep 23, 2024 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1, 6–11, 13–20, 22–24, and 26–28 on all petitioned grounds, finding a reasonable likelihood of success and declining discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 11
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Petitioner contends that the MSI-H Study Record is prior art under 35 U.S.C. § 102(a) and is not covered by an exception under 35 U.S.C. § 102(b). Pet. 8. The parties agree that the MSI-H Study Record was publicly available by June 12, 2013. Id. at 7; Prelim. Resp. 19 (“JHU submitted the MSI-H Study Record on June 10, 2013, and it was posted on clinicaltrials.gov on approximately June 12, 2013”).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“summarized above, we determine that the information presented in the Petition establishes that Petitioner has a reasonable likelihood of prevailing in showing that claim 1 would have been obvious in view of the MSI-H Study Record. We are persuaded that the MSI-H Study Record discloses the limitations of claim 1. Pet. 16–24. We are further persuaded that a person of ordinary skill in the art would have been motivated to modify the MSI-H Study Record with Pernot and Benson to benefit from the improved outcomes in treating MSI-H colorectal patients with the drug therapeutic. Id. at 41–44. We are also persuaded that a person of ordinary skill would have been motivated to test patients to determine their MSI-H status as such testing was routine in the art. Id. at 44–45. We are also persuaded that a person of ordinary skill would have been motivated to combine the teachings of the MSI-H Study Record and Benson to treat patients with metastatic and advanced disease. Id. at 46–47.” slip op. at 27
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,934,356 - PTAB · Sep 5, 2024 · IPR2023-01300 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–13 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
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). A decision to institute is “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons set forth below, 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 the challenged claims in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have possessed a strong understanding in the use and development of genetics and genomics approaches for detecting or monitoring human diseases, such as spatial detection of a target analyte (e.g., mRNA or DNA) in a tissue, and would typically have a Ph.D. in a relevant field (e.g., molecular biology, genetics, and bioinformatics) with two years of experience. Pet. 21–22 (citing Ex. 1044 ¶¶ 24–36). For the purposes of its Preliminary Response, Patent Owner does not provide its own proposed level of skill. Prelim. Resp. 7. For purposes of this Decision, we apply Petitioner’s unchallenged definition as it is consistent with the cited prior art and disclosure of the ’142 patent.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Thus, according to claim 1, to synthesize a first/second plurality of DNA products by performing a synthesis reaction, the “DNA products” must 1) use the oligonucleotides collected in steps (a) and (b) as templates from which the DNA is synthesized, and 2) incorporate a source location-identifying nucleic acid sequence.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner
“(2) Analysis Neither party has offered a construction for “collecting oligonucleotides under conditions that release them” in claim 1. We note that, in the related litigation, the district court determined that “under conditions that release” should have its plain and ordinary meaning. Ex. 1052, 38. For purposes of institution, we also apply the plain and ordinary meaning of this claim phrase and do not need to expressly construe the claim phrase for purposes of institution. On this record, for the reasons explained by Petitioner and as supported by its declarant testimony, we conclude Petitioner has sufficiently shown that So-456 discloses the “collecting oligonucleotides under conditions that release them” limitation recited in claim 1.” slip op. at 42
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,473,142 - PTAB · Aug 30, 2024 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Remand
On remand, the Board instituted inter partes review of claims 1–17, 20–21, 24–26, and 29–34 on all grounds stated in the Petition.
RulingsRemand decision- Director reviewOther
“Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17 (“Inst. Dec.”). Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel. Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Director Review Panel (“DRP”) vacated our decision and remanded the case to this panel with a revised construction for claim 1. Paper 23 (“DRP Dec.”).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect (2018). Upon reconsideration of the briefing and the evidence of record in light of the DRP’s claim construction, we conclude that Petitioner has established a reasonable likelihood of prevailing on its assertion that at least one of the challenged claims is unpatentable. Accordingly, we grant institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We find that Petitioner has demonstrated a material error by the Office in the prior consideration of Morales-Sanfrutos, Straus, Singh, and Lees. For instance, under the second prong of Advanced Bionics, we consider “(c) the extent to which the asserted art was evaluated during “(e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art.” Becton, Dickinson, 17–18. We agree with Petitioner that the Office overlooked Morales- Sanfrutos’ and Singh’s teachings during examination and reexamination. Pet. 79. Although Morales-Sanfrutos, Straus, and Singh were listed on an IDS, they were not the subject of a rejection during examination or reexamination. Moreover, for the reasons discussed below at this stage with regard to Petitioner’s grounds over Morales-Sanfrutos, as evidenced by Straus, and over Singh, Petitioner sufficiently demonstrates that the Office materially erred in overlooking Morales-Sanfrutos’s and Singh’s teachings regarding their linker structures. Id. Further, to the extent the Lees’ teachings were considered during examination and reexamination, Lees’ disclosure of a homobifunctional sulfone linker was overlooked. Lees’ homobifunctional linker, which Patent Owner argues is substantially similar to Harris’ homobifunctional linker, which Petitioner chiefly relies upon in Grounds 2–5, was not the subject of a rejection during examination. Pet. Resp. Brief 1; Prelim. Resp. 25–26. We agree with Petitioner that only Lees’ heterobifunctional linker was applied in a rejection during examination. Pet. Resp. Brief 1; Ex. 1018, 42–43, 62. 4. Conclusion For the foregoing reasons, we decline to exercise discretion to deny institution under § 325(d).” slip op. at 27
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the (prior art itself can reflect the appropriate level of ordinary skill in the art). To the extent a more precise definition is required, we apply Petitioner’s unopposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - PTAB · Jul 22, 2024 · IPR2024-00276 · APJ Michael J Fitzpatrick · IPR · Institution
Instituted review of claims 1–3, 6, 12, 14, 16, 18, and 19 based on a reasonable likelihood of success on the asserted anticipation and obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review requires that “the information presented in the petition filed under section 311 and any response filed under section 313 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). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that there is a reasonable likelihood that Petitioner would prevail with respect to at least one claim. Accordingly, we grant the Petition.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“contacting mucosal tissue of the upper airway with the treatment delivery portion, without piercing the mucosal tissue,” as recited in claim 1. Prelim. Resp. 8; see Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631 (Fed. Cir. 1987) (“A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.”). As will become apparent from Patent Owner’s arguments, central to the dispute between the parties is Petitioner’s mapping of Baker to limitation [b] and, in particular, to the recited “treatment delivery portion” of the device. In Petitioner’s view, Baker’s inflatable chamber 28 constitutes part of the recited “treatment delivery portion.” See Pet. 28 (“An energy delivery member including an inflatable chamber 28 is located at the distal tip of insertion wand 24.” (citing Ex. 1013, 16:19–26, 17:22–32, 20:35–39, Fig. 5; Ex. 1002 ¶75)). Petitioner further points out, with supporting evidence, that the inflatable chamber contacts mucosal tissue without piercing it. Id. at 34 (citing Ex. 1013, 17:22–36, Fig. 5; Ex. 1002 ¶84). slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“underlying the mucosal tissue, and wherein delivering the energy comprises ablating the nerve tissue.” Ex. 1001, 29:64–67. In challenging claim 6 as obvious, Petitioner relies on Chen for teaching targeting of nerve tissue with radiofrequency energy and on Edwards-535 for teaching targeting of underlying tissue (including nerves) without harming the mucosal surface. Pet. 80–81 (citing 1017, 239–240; 1010, 4:60–67, 6:10–37; Ex. 1002 ¶171). Petitioner explains why a person of ordinary skill in the art would have combined the teachings of Baker, Edards-535, and Chen and had a reasonable expatiation of success in doing so. Id. at 61–68. Patent Owner does not dispute Petitioner’s reliance on Edwards-535 and Chen to reach the additional subject matter recited in claim 6. Nor does Patent Owner dispute Petitioner’s reasons for combining Edwards-535 and Chen with Baker or that a person of ordinary skill in the art would have had a reasonable expectation of success in such an endeavor. Prelim. Resp. 15– 535, and Chen fails to satisfy limitation [b] of claim 1, from which claim 6 ultimately depends. Prelim. Resp. 15. However, as discussed above, we have already determined there is a reasonable likelihood that Baker alone discloses limitation [b] of claim 1. There is a reasonable likelihood of Petitioner prevailing on Ground 3 as to both claim 1 and claim 6. We decline, at this time, to address the other claims challenged in Ground 3. SAS, 138 S. Ct. at 1356.” slip op. at 17
§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,415,194 - PTAB · Jul 22, 2024 · IPR2024-00275 · APJ Michael J Fitzpatrick · IPR · Institution
The Board instituted review of claims 9, 14, 16, 18, 20, 22–24, 44, and 46 based on a reasonable likelihood of prevailing on the asserted anticipation and obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Institution of an inter partes review requires that “the information presented in the petition filed under section 311 and any response filed under section 313 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). Determining whether to institute has been delegated to the Board. See 37 C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the Petition and the Preliminary Response, and for the reasons explained below, we determine that there is a reasonable likelihood that Petitioner would prevail with respect to at least one claim. Accordingly, we grant the Petition.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“argues that we “should exercise . . . discretion to deny institution of Ground 1 under 35 U.S.C. § 325(d).” Prelim. Resp. 8 (emphasis added). However, we do not institute on a ground-by-ground basis. See 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.”); see also SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018) (holding that the Director’s prior “partial institution practice” was contrary to 35 U.S.C. § 314(a)). Even assuming Patent Owner requests that we exercise discretion to deny the entire Petition, its discretionary denial arguments could not support such a request because those arguments are limited to Ground 1. Patent Owner does not argue or present any basis for exercising our discretion under 35 U.S.C. § 325(d) as to any of the additional grounds. And, as discussed below, there is a reasonable likelihood that the Petitioner will prevail with respect to at least 1 of the claims challenged in at least one of those additional grounds. For this reason alone, discretionary denial under 35 U.S.C. § 325(d) is not warranted.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“step [b], i.e., “contacting a treatment element of the treatment device with mucosal tissue in the patient’s nasal airway,” as recited in claim 9. Prelim. Resp. 17; see Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631 (Fed. Cir. 1987) (“A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.”). As will become apparent from Patent Owner’s arguments, central to the dispute between the parties is Petitioner’s mapping of Gertner to limitation [b] and, in particular, to the recited “treatment element.” In Petitioner’s view, Gertner’s distal end 216 and expandable component 218 together form the recited “treatment element.” As Petitioner explains it, Gertner discloses that “the distal end 216 emits light from ‘within’ the expandable component 218, such that the light emitter and expandable component 218 (which together constitute distal end 216) act as a treatment element.” Pet. 30 (citing Ex. 1013 ¶¶103, 106, 107; Ex. 1002 ¶64). Petitioner further points out, with supporting evidence, that the expandable component contacts mucosal tissue. Id. (citing Ex. 1013 ¶¶37, 103).” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Edwards-535. Pet. 61–64. Claim 16 recites: “A method as in claim 9, wherein adjusting the shape comprises forming at least one bend in a shaft of the treatment device.” For this additional subject matter, Petitioner points us to the bend in the structure that is designated with reference numeral 124 in Edwards-535, as illustrated in Figure 3B. Pet. 61–62. Petitioner also argues, with supporting evidence, that, even absent this disclosure, it would have been obvious to form a bend, as it is well known in the art to provide bendable catheters to facilitate insertion of a medical device. Id. at 62–64 (citing Ex. 1002 ¶¶130–132). Patent Owner’s sole argument is Edwards-535 fails to disclose limitation [b] of claim 9, from which claim 16 depends. Prelim. Resp 31– 32. That argument is not persuasive for reasons already discussed. Although we have already held that the single-claim threshold of § 314(a) has been met with respect to independent claim 9, we nonetheless further determine that there is a reasonable likelihood of Petitioner prevailing in showing that dependent claim 16 would have been obvious over Edwards-535.” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 9,072,597 - PTAB · Jul 22, 2024 · IPR2024-00282 · APJ Zhenyu Yang · IPR · Institution
The Board instituted review of claims 1–4 and 7–9 on all asserted grounds after finding a reasonable likelihood that claims 1–3 and 7–9 are obvious over Edwards-’535 and Stern.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter 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). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on all grounds raised in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS Level of Ordinary Skill in the Art Petitioner argues that an ordinarily skilled artisan at the relevant time would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in engineering or a related discipline and (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices, including medical devices that deliver energy to tissue. Pet. 17 (citing Ex. 1002 ¶¶ 24–28). Patent Owner does not address the skill level in its Preliminary Response. At this stage, we find Petitioner’s definition of the level of ordinary skill in the art sufficiently supported by the record and apply it for purposes of this Decision.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner argues that the preamble of claim 1 “to treat rhinitis” is not limiting. Pet. 18. According to Petitioner, the body of claim 1 recites a structurally complete apparatus, and the preamble only states an intended use for the device without limiting the claimed structure. Id. at 18–19. Patent Owner does not propose any claim construction. On this record, we find Petitioner’s argument persuasive and determine that the preamble of claim 1 “to treat rhinitis” is not limiting. On this record and for purposes of this Decision, we see no need to expressly construe any other claim term.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). We still “must further consider the factual questions of whether a person of ordinary skill in the art would be motivated to combine those references, and whether in making that combination, a person of ordinary skill would have had a reasonable expectation of success.” Dome Patent L.P. v. Lee, 799 F.3d 1372, 1380 (Fed. Cir. 2015). Based on the current record, and for purposes of this Decision, we find Petitioner has shown sufficiently that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” See In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (citations omitted). slip op. at 13
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 11,766,286 - PTAB · Jul 22, 2024 · IPR2024-00278 · APJ Michael A Valek · IPR · Institution
The Board instituted inter partes review of claims 1, 4–6, 9, 10, 12, 13, and 15–17 on all grounds presented in the Petition.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Considering the arguments and evidence of record, we determine that the Petition demonstrates “a reasonable likelihood that [P]etitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends a person of ordinary skill in the art (“POSITA”) would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in engineering or a related discipline and (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices, including medical devices that deliver energy to tissue. Pet. 19–20 (citing Ex. 1002 ¶¶ 24–28). Patent Owner does not respond to Petitioner’s description of a POSITA in its Preliminary Response. At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficiently supported by the record and apply it for purposes of this decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends “the Board need not construe any terms because the Challenged Claims are invalid under any reasonable interpretation.” Pet. 20. At this stage, Patent Owner does not respond to this contention, nor propose any express claim construction of its own. For this decision, and given that neither party seeks any express claim construction, we determine that no express claim construction is necessary. To the extent our consideration of Petitioner’s grounds touches on any implicit issues of claim construction, those are addressed in our analysis below.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“several reasons. First, Petitioner’s reasoning for combining Edwards-535 and Stern is supported by testimony from Dr. Martin who identifies multiple, specific reasons for the combination. Ex. 1002 ¶¶ 103–122, 129–148. This testimony is not conclusory and is supported with numerous citations to other evidence of record. Id. Patent Owner does not offer any countervailing testimony with its Preliminary Response, electing instead to rely on attorney argument at this stage. Second, Patent Owner’s assertions that Petitioner’s reasoning is insufficient because Stern describes treating the endometrium and ablating different tissue, i.e., surface versus underlying tissue, are undermined by Edwards-535’s citation to Baker. As Petitioner points out, “Edwards-’535 points a POSITA” to, and incorporates teachings from, Baker. Pet. 47. This is true even though Baker, like Stern, is largely focused on treating the uterus and describes preferred embodiments for delivering RF energy to the endometrium. See, e.g., Ex. 1011, Abstr., 3:5–9, 5:50–65. Moreover, Petitioner offers evidence to show that Baker and Stern depict similar devices, including the figure from Dr. Martin’s declaration reproduced below. See Ex. 1002 ¶¶ 117–119, 144–147. Dr. Martin’s figure above is a side-by-side comparison of Figure 8 of Baker and Figure 4a of Stern, depicting devices that, at least on their face, appear to share a similar shape and configuration. See id. ¶¶ 119, 146 (testifying that the comparison above shows “Baker and Stern both depict very similar devices”). At this stage, Patent Owner does not dispute that Petitioner’s comparison is apt, nor otherwise address Petitioner’s reliance on Baker as evidence of a motivation to combine Stern. Thus, on the current record, we agree with Petitioner that Edwards-535’s express citation to Baker suggests that a POSITA would have been motivated to combine the similar teachings Petitioner identifies in Stern. Third, Stern also contradicts Patent Owner’s assertion that a POSITA would have considered its teachings to be inapplicable to treating the nasal concha as taught in Edwards-535. While Stern is primarily concerned with endometrial ablation applications, that does not mean its teachings are limited to such. Indeed, Stern explains that its “electrode partitioning structure” may be used to treat “other body organs or tissues either externally or internally” and that its “principles with respect to the delivery of controlled RF energy” can be applied “not only for controlled destruction of tissue but also for controlled heat treatment of tissue.” Id. Such teachings further support the testimony of Dr. Martin that “[a] POSITA would have known that technology from ablation devices for one part of the body would be applicable to devices used in other areas of the body.” Pet. 41 (citing Ex. 1002 ¶ 117–121; Ex. 1033, 18:27–40). We also disagree with Patent Owner’s argument that “Edwards-535 and Stern are so in conflict with one another that they rise to the level of teaching away.” Prelim. Resp. 21. A teaching away requires that the reference “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). But Patent Owner has not shown that any of the references cited here discourage the articulated combination of Stern’s electrode configuration, i.e., multiple pairs of bipolar electrodes connected to separate radiofrequency output channels, with Edwards-535’s device. To the contrary, Stern expressly states that its “electrode partitioning structure” can be used for other applications (see Ex. 1033, 18:27–40), which on the current record would seem to include Edwards-535’s device for ablating nasal tissue.” slip op. at 22
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,033,318 - PTAB · Jul 22, 2024 · IPR2024-00277 · APJ Michael A Valek · IPR · Institution
Instituted IPR of claims 1–4, 6–12, and 16 on all asserted grounds; the Board found a reasonable likelihood of prevailing on the Edwards-535, Kong, and Stern obviousness challenge.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Considering the arguments and evidence of record, we determine that the Petition demonstrates “a reasonable likelihood that [P]etitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had (1) a Doctor of Medicine (M.D.) or at least a bachelor of science degree in engineering or a related discipline and (2) at least three years of experience in the clinical use, design, development, and/or testing of medical devices, including medical devices that deliver energy to tissue. Pet. 20–21 (citing Ex. 1002 ¶¶ 27–29; Ex. 1004 ¶¶ 24–28). Patent Owner does not respond to Petitioner’s description of a POSITA in its Preliminary Response. At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficiently supported by the record and apply it for purposes of this decision.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends “the Board need not construe any terms because the Challenged Claims are invalid under any reasonable interpretation.” Pet. 21. At this stage, Patent Owner does not respond to this contention, nor propose any express claim construction of its own. For this decision, and given that neither party seeks any express claim construction, we determine that no express claim construction is necessary. To the extent our consideration of Petitioner’s grounds touches on any implicit issues of claim construction, those are addressed in our analysis below.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“On the current record, Patent Owner’s arguments are unavailing for several reasons. First, Petitioner’s reasoning for combining Edwards-535 and Stern is supported by testimony from its declarants who identify multiple, specific reasons for the combination. Ex. 1002 ¶¶ 93–94; Ex. 1004 ¶¶ 75–97. This testimony is not conclusory and is supported with numerous citations to other evidence of record. Id. Patent Owner does not offer any countervailing testimony with its Preliminary Response, electing instead to rely on attorney argument at this stage. Second, Patent Owner’s assertions that Petitioner’s reasoning is insufficient because Stern describes treating the endometrium and ablating a different tissue, i.e., surface versus underlying tissue, are undermined by Edwards-535’s citation to Baker. As Petitioner points out, “Edwards-’535 instructs a POSITA to look to Baker for how to dispose electrodes on the surface of a membrane.” Pet. 47. This is true even though Baker, like Stern, is largely focused on treating the uterus and describes preferred embodiments for delivering RF energy to the endometrium. See, e.g., Ex. 1011, Abstr., 3:5–9, 5:50–65. Moreover, Petitioner offers evidence, including the figure reproduced below, to show that “Baker and Stern depict similar devices for ablating tissue.” Pet. 46. Petitioner’s figure above is a side-by-side comparison of Figure 8 of Baker and Figure 4a of Stern, depicting devices that, at least on their face, appear to share a similar shape and configuration. Petitioner offers a similar figure showing that both Baker and Stern teach the arrangement of “electrodes in rows.” See id. at 47 (showing side-by-side comparison of Figure 8 of Baker to Figure 19 of Stern). At this stage, Patent Owner does not dispute that Petitioner’s comparisons are apt, nor otherwise address Petitioner’s reliance on Baker as evidence of a motivation to combine Stern. Thus, on the current record, we agree with Petitioner that Edwards-535’s express citation to Baker suggests that a POSITA would have been motivated to combine the similar teachings Petitioner identifies in Stern.” slip op. at 21
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,241,271 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 13, 2024 · IPR2022-01600 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–20 are unpatentable as obvious: claims 1–7 and 9–20 over Olmos and Varela ’774, and claim 8 over Olmos, Varela ’774, and Oglaza.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“invention. Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”): would have had a bachelor’s degree in mechanical engineering or biomedical engineering and two or more years of experience in biomechanical engineering, biomedical engineering, and/or spinal implant devices. A person could also have qualified as a POSITA with some combination of more formal education (e.g., an M.D.) and less technical experience or less formal education and more technical or professional experience in the foregoing fields, and would have had further appreciation of various technical concepts in this field. Pet. 18 (citing Ex. 1002 ¶¶ 32–35). Patent Owner does not dispute Petitioner’s proposal. See Response 8. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 13
- Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed
“We credit Mr. Drewry’s testimony that it would have been well within the ordinary skill of a POSITA to make the proposed modifications. See Ex. 1002 (Drewry Decl.) ¶¶ 34, 56–71 (discussing the qualifications of a POSITA and the types of engineering concepts the POSITA would have understood); Ex. 1030 (Drewry Reply Decl.) ¶¶ 37, 48–56, 59–66. To the extent Mr. Culbert testifies otherwise, we do not find such testimony persuasive. Indeed, Olmos itself further supports Mr. Drewry’s testimony that a POSITA would have known how to modify dimensions to fit specific needs and make changes necessary to adapt features from one embodiment to fit another. See Ex. 1006 (Olmos) ¶¶ 153, 188 (providing a range of implant sizes and noting that “specific dimensions” of any disclosed 9 Patent Owner’s citation to Mr. Drewry’s deposition transcript at 87:13– 88:9 appears to be incorrect. We understand that the intended citation is 69:34–70:7. embodiment can be varied as is apparent to a POSITA and “all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein to form various combinations and sub-combinations”). Given the POSITA’s ability to make the proposed modifications, we do not find that Patent Owner’s evidence regarding the number of modifications required undermines Petitioner’s articulated reasoning for the combination.” slip op. at 35
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that “no terms require constructions differing from their plain and ordinary meaning.” Pet. 19. Patent Owner states that it “takes no position on Petitioner’s assertion because the Board need not construe any claim term to find that the Challenged Claims are not unpatentable.” Response 8. We find that for purposes of this Decision, we need not construe any claim term. See 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))).” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
Patent outcomesUS 10,973,649 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,973,649 - PTAB · Jun 13, 2024 · IPR2024-00240 · APJ Deborah Katz · IPR · Institution
The Board instituted inter partes review of claims 1–42 on all asserted grounds, finding a reasonable likelihood of success and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Director may not authorize an inter partes review “unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 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). We determine whether to institute a post grant review on behalf of the Director. See 37 C.F.R. § 42.4(a). The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Upon considering the Petition, the Preliminary Response, and the evidence of record, we determine that Petitioner has demonstrated there is a reasonable likelihood that the petition would prevail in showing that at least one challenged is unpatentable. Accordingly, we institute inter partes review of all challenged claims on all asserted grounds. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“patient is MSI-H after enrollment in a study in which pembrolizumab is to be administered is not within the scope of the claim step “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab.” At this point in the proceeding, though, we do not interpret the claim step as meaning anything other than the treatment of colorectal cancer patients after they have been determined to be microsatellite instability high or DNA mismatch repair deficient. Although the term “in response to” in claim 1 requires that treatment of the patient occur after the determination that the colorectal cancer is MSI-H, we do not interpret the term to mean that other patients are not treated or that the recruitment and enrollment of patients for a clinical trial has any bearing on the steps recited in claim 1. We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Patent Owner has not directed us to evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition excludes treatment of other patients without the condition, although it does require that treatment of the patient occur after the determination that the colorectal cancer is MSI-H. The language of claim 1 refers only to patients that are determined to have microsatellite instability high or DNA mismatch repair deficient colorectal cancer, not to other patients. (See Ex. 1001, 25:40–50.) At this point in the proceeding, the record does not indicate that the treatment of patients determined not to be MSI-H is be factored into whether the teaching of treating patients determined to be MSI-H anticipates the method of claim 1. At this point in the proceeding, we construe the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. (See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); see Neugut Decl., Ex. 1003, ¶¶ 58–62.) At this point in the proceeding, Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Furthermore, to the extent the MSI-H Study Record does not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating the patient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. (See Ex. 1006, 3741.) Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with prembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD- 1 inhibitor (see Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (see Ex. 1032, e27817-5). (See Pet. 44.) Thus, based on the entire record before us, Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,591,393
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.