- PTAB · Sep 27, 2024 · IPR2024-00650 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR of claims 1–38 on 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
“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 an inter partes review on behalf of the Director. See 37 C.F.R. § 42.4(a).” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“determined to be microsatellite instability high or DNA mismatch repair deficient were placed into a study arm and then treated with pembrolizumab. (See Ex. 1005, Ex. 1003 ¶¶ 60–73.) Because treatment of the patients was performed only after MSI-H status was determined, the MSI-H Study Record teaches treating the patients “in response to” determining their MSI- H status.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“have been expected, Petitioner cites to Brown as teaching that PD-1 inhibitors are inherently more effective when treating tumors comprised of cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1034, 747).) Petitioner argues further that Duval teaches that MSI-H cancers have cells that are easy for immune cells to recognize. (See Pet. 41 (citing Ex. 1087, 5002).) Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. (See Ex. 1003 ¶¶ 124, 130, 132; see Pet. 41.) Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. (See Pet. 41 (citing Ex. 1003 ¶ 130).) Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were successfully treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. (See Pet. 42 (citing Ex. 1003 ¶¶ 131, 132).)” slip op. at 18
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that one of ordinary skill in the art relevant to the ’219 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. (See Pet. 11 (citing Neugut Decl., Ex. 1003 ¶19).) Petitioner argues further that the ordinarily skilled artisan would have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. (See id.) Dr. Neugut’s testimony supports Petitioner’s arguments regarding the level of skill that an ordinarily skilled artisan in the relevant field would have. (See Ex. 1003 ¶ 19.) Accordingly, in the analysis below, and in the absence of argument by Patent Owner to the contrary, we apply the level of skill set forth by Petitioner and refer to Dr. Neugut’s testimony of what one of ordinary skill in the art would have understood at the time the application that became the ’491 patent was filed, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,634,491 - Apotex Inc. v. Novo Nordisk A/SInstitutedPTAB · Sep 11, 2024 · IPR2024-00631 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1–10 on all petitioned grounds, finding a reasonable likelihood of unpatentability, and granted Apotex’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016); see also 35 U.S.C. § 314(a). In Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential), the Board set forth six non-exclusive factors for determining “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Id. at 6. These factors are as follows: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Id. at 5–6. In evaluating these factors, we take a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review. Id. at 6. The Director has also issued interim guidance to the Board on applying the factors. See Katherine K. Vidal, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition shows “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).” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Under 37 C.F.R. § 42.5(b), we “may waive or suspend a requirement of [part 42 of the Board’s rules] and may place conditions on the waiver or suspension.” Here, we agree with Petitioner that it has shown sufficient reason for us to waive the one-month from institution joinder motion deadline. See 37 C.F.R. § 42.122(b). Petitioner waited until it had a sufficient business reason to file this Petition, and subsequently promptly filed its Petition and Motion for Joinder. Most critically, Petitioner raises no new unpatentability grounds, the trial schedule for the Mylan IPR need not be adjusted, and Petitioner agrees to serve in a silent understudy role. We determine that joinder with the Mylan IPR is appropriate under the circumstances. Accordingly, we grant Petitioner’s Motion for Joinder.” slip op. at 13
Discretionary denialPatents in suitUS 10,335,462 - PTAB · Sep 10, 2024 · IPR2024-00563 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1, 12, and 28 because Petitioner showed a reasonable likelihood of prevailing on obviousness over Gil, Norden, Dean, Alphagan, and Federal Register.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“partes review, “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. Med-El Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). “If a condition in the first part of the framework is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review.” Id. at 8–9. “At bottom, this framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9.” slip op. at 17
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“the District of New Jersey is more than three years, argues that “a trial may not be held until 2026—well after a FWD would be expected in this proceeding.” Pet. 15 (citing Ex. 1027, 2); Reply 8. Based on this evidence of the median time to trial in the district, we find factor 2 weighs in favor of institution. See Fintiv Memo 3 (“[W]hen considering the proximity of the district court’s trial date to the date when the PTAB final written decision will be due, the PTAB will consider the median time from filing to disposition of the civil trial for the district in which the parallel litigation resides.”)” slip op. at 22
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther
“guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“In claim construction, “the claims themselves provide substantial guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d 1314. Claim 1 is directed to “[a] method for reducing eye redness in a human subject having ocular hyperemia.” The preamble is limiting because (1) it provides the antecedent bases for “said human” and “said reduction of eye redness” recited in the body of the claim; and (2) “it is a statement of the intentional purpose for which the method must be performed.” See Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1341–43 (Fed. Cir. 2021). The preamble, however, does not require that eye redness is actually reduced. Id. Nor does the body of the claim recite any efficacy requirement.” slip op. at 24
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,596,600 - PTAB · Aug 22, 2024 · IPR2024-00580 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1, 3–6, and 8 on all asserted grounds, finding a reasonable likelihood that at least claim 1 would be shown obvious over the ’772 Publication and Snowdy.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Beginning with independent claim 1, we determine that Petitioner has met its burden for institution. Based on the current record, Petitioner has shown a reasonable likelihood of succeeding in establishing that the combination of the ’772 Publication and Snowdy renders at least claim 1 obvious.” slip op. at 18
- Skill levelSkill level petitioner adoptedOther
“Pet. 12 (citing Ex. 1005 ¶¶ 111–115). Patent Owner states that it does not dispute this definition for purposes of the Preliminary Response. Prelim. Resp. 16. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’462 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 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., 200 F.3d at 803)).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundOther
“We agree with Patent Owner on the record before us that Petitioner does not appear to offer sufficient evidence and reasoning as to why a POSA would have modified AAVrh.10 at position 665 as described as opposed to other modifications based solely on the disclosure of the ’772 Publication. We do agree with Petitioner, however, that on the record before us, Snowdy provides such sufficient evidence and reasoning. See Pet. 47–52.” slip op. at 26
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,680,274 - PTAB · Aug 13, 2024 · IPR2024-00467 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on all challenged claims based on the asserted obviousness ground over Gil, Norden, Dean, Alphagan, and Federal Register.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Advanced Bionics, 8. As explained above, during prosecution of the ’245 patent, the examiner issued a nonstatutory double patenting rejection because the claims were “not patentably distinct from” the ’742 patent claims.13 See supra Section I.H (citing Ex. 1010, 96). Petitioner argues that “[i]t was material error for the Examiner to both acknowledge that the ’245 claims were patentably indistinct from the ’742 claims and yet ignore the FWD and allow the claims despite the Board’s prior findings.” We find Petitioner’s argument persuasive. To determine whether Petitioner has sufficiently shown material error, we look at, for example, “the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection.” Advanced Bionics, 9 (citing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 10–11 (Dec. 15, 2017)). Petitioner asserts Gil, Norden, Dean, Alphagan, and Federal Register in this” slip op. at 18
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“previously denied its motion to stay. Ex. 2029. Thus, factor 1 weighs in favor of denying institution.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to expressly construe any claim term. Patent Owner appears to suggest, although it does not explicitly argue, that the claims require “a single drop of [0].025% brimonidine.” See Prelim. Resp. 6; see also id. at 27 (arguing Gil is “with multi-dosed 0.03% brimonidine”); id. at 28 (arguing Dean is with “multi-dosed concentrations”). To the extent our understanding is correct, Patent Owner should expressly discuss at trial any construction that would so limit the claim. Such discussion should be set forth in a separate section of a response, if filed, designated for claim construction; claim construction positions should not be merely included in arguments over the merits on patentability.” slip op. at 24
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art Petitioner asserts that: A person of ordinary skill in the art (“POSA”) would have been a composite person (or team) that included a medical doctor and pharmaceutical formulator. EX-1014, ¶¶60-61; EX-1013, ¶¶16, 22-24. The medical doctor would be an ophthalmologist with at least three to four years of experience in clinical trials and FDA regulation of eye products and would have experience in the use of topical brimonidine and apraclonidine and topical vasoconstrictors such as naphazoline and tetrahydrozoline. EX-1014, ¶60. The pharmaceutical formulator would have a doctorate in pharmaceutics or a related degree and at least three to five years of experience developing eye drop formulations for clinical trial and regulatory approval. EX-1013, ¶16. Pet. 16–17. Patent Owner does not, at this point, dispute this proposed definition of the ordinarily skilled artisan. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s definition of the person of ordinary skill in the art as it appears consistent with the skill level reflected in the prior art of record and the disclosure of the ’245 patent.” slip op. at 24
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 11,833,245 - 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
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.