- Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Oct 17, 2024 · IPR2023-00862 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1 and 2 are unpatentable because Aerschot anticipates them.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“Patent Owner’s argument that Dr. Baran is principally experienced in P(V) chemistry presupposes that experience indicates an ignorance of P(III) chemistry. We do not find this position consistent with the breadth of Dr. Baran’s experience as indicated by his Curriculum Vitae. See Ex. 1003, 47–102. We weigh the testimonies of both Dr. Baran and Dr. Hrdlicka, against the cumulative weight of the evidence of record in assessing their credibility and probative value.” slip op. at 8
- Skill levelSkill level board ownOther
“The parties’ proposed definitions of the level of ordinary skill, although different facially, are similar substantively. For example, both parties argue that a POSA would have high levels of skill, with advanced degrees and/or extensive work experience in organic chemistry.3 See Pet. 12; PO Resp. 20–21. In addition, Petitioner contends that a POSA would have had experience in the development of oligonucleotide building blocks. Pet. 16. Similarly, Patent Owner asserts that a POSA would have had education and/or experience in “the development and syntheses of nucleosides, nucleotides, and nucleic acids.” PO Resp. 20–21. After considering the parties’ arguments and the prior art, we determine that a POSA would have had a Ph.D. (or equivalent degree) in organic chemistry or medicinal chemistry, with at least two to three years of post-graduate work experience in the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis. In addition, an individual with a Bachelor’s or Master’s degree and at least five years of work experience in these fields also would qualify as a POSA.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“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 address the construction of any claim term.” slip op. at 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be disclosed in a single piece of prior art. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). For a claim directed to a genus, if a prior art reference discloses a species falling within the claimed genus, the species anticipates the genus. In re Slayter, 276 F.2d 408, 411 (CCPA 1960); see also Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298 (Fed. Cir. 2009) (stating that when a claim element is written in Markush form, “the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art”).” slip op. at 5
Patent outcomesUS 8,541,569 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 8,541,569 - 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 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 · Aug 23, 2024 · IPR2024-00526 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR of claims 36–70 on all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on the challenged claims.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314(a), which provides that an 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.” For the reasons discussed below, we determine Petitioner has demonstrated a reasonable likelihood that the challenged claims of the ’554 patent are unpatentable. Accordingly, we institute an inter partes review of all challenged claims on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 3
- BurdenDecided for petitioner
“We are not persuaded by Patent Owner’s arguments. Even if Chen does not explicitly determine three-dimensional positional information of nucleic acid molecules in its paper, Petitioner has provided sufficient evidence, for purposes of institution, that the combination of asserted prior art would have given a skilled artisan reason to use MERFISH to “determin[e] three-dimensional positional information of . . . nucleic acid molecules,” as recited in claim 36, with a reasonable expectation of success.29 Petitioner does not rely on the bare disclosure of optical sectioning and/or z-scanning to argue that the combination of asserted art suggests the limitation at issue. Rather, Dr. Cyzmmek testifies that, because Chen “had the goal of identifying ‘distinct spatial distribution pattern of RNAs,” a skilled artisan “would have been motivated to use the MERFISH 29 In this regard, we also make clear that claim 36, a system claim, does not require a step of determining three-dimensional positional information of nucleic acid molecules. Rather, it only requires program instructions that are executable by a processor to cause the processor to perform the step. 39 method for 3D investigation.” Ex. 1002 ¶ 207. Citing to Larsson30 and Parillo,31 Dr. Cyzmmek further testifies that “[t]hree-dimensional FISH was routine and well-known long before the 2015 priority date.” Id. ¶ 208. Dr. Cyzmmek opines that, because “MERFISH was an extension of existing FISH technologies,” a skilled artisan would have reasonably expected it to also be capable of similar three-dimensional imaging.” slip op. at 39
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“36 Petitioner also asserts that the Board should not exercise our discretion to deny institution under 35 U.S.C. § 325(d). Pet. 66–68. Patent Owner did not address issues relating to 35 U.S.C. § 325(d) in the Preliminary Response. Under these circumstances, we decline to exercise our discretion to deny institution under 35 U.S.C. § 325(d).” slip op. at 48
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“At this point, it appears, based on the parties’ submissions that, as of the institution decision date, fact discovery will still be ongoing, expert discovery will not have begun, and the deadline for filing dispositive motions will still be some time away. Furthermore, we note that, although the Court has issued a claim construction order, none of the construed terms were of the ’554 patent claims. See generally Ex. 2020.” slip op. at 54
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,542,554 - 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.