- PTAB · Apr 21, 2025 · IPR2024-01506 · APJ Georgianna W Braden · IPR · Institution
The Board instituted IPR of claims 1–16 on all asserted challenges, finding a reasonable likelihood that Kivioja anticipates at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“framework set forth under Advanced Bionics, LLC v. Med-El Electromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 7 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics” or “AB”). Under the first prong of that framework, we must determine whether the same or substantially the same art or arguments previously were presented to the Office. If so, we turn to the second prong which focuses on whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of the challenged claims. Id. at 8. a. Advanced Bionics Prong One: whether “the same or substantially the same art or arguments previously were presented to the Office” In evaluating whether the same or substantially the same prior art or arguments were previously presented to the Office, the Board has identified several non-exclusive factors for consideration. Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (Paper 8) (precedential § III.C.5, first para.) (“the Becton Dickinson factors”). Specifically, we must weigh the following non-exclusive factors: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination, the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; (e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of the asserted prior art; and (f) the extent to which additional evidence and facts presented in the Petition warrant reconsideration of prior art or arguments. Becton Dickinson, at 17–18. Thus, the Becton Dickinson factors are framed as comparing the art or arguments in a petition against what was before an examiner during prosecution.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Construction is needed only for those terms “that are in controversy, and only to the extent necessary to resolve the controversy.” See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Although Petitioner provides us with constructions for “appended,” “identifier site” and “indexing site,” the meaning of these terms are not in controversy at this stage of the proceeding and their constructions will not aid in our analysis. We acknowledge, the ’241 patent. See Ex. 1005, 4:37–40, 4:45, 4:51–53.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningOther
“2. “identifying sequence reads with identical identifier and target sequences as duplicates” The parties do not request construction of the limitation, “identifying sequence reads with identical identifier and target sequences as duplicates.” Nonetheless, we invite the parties to address the construction of this limitation after institution. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (claims are construed only to the extent necessary to resolve a dispute). Specifically, the parties may wish to address whether the “same identifier and nucleic acid fragment” means that the sequences actually are identical. The ’241 patent states: “A duplicate sequencing read can be a sequencing read with the same identifier site and target sequence as another sequencing read in the population of sequencing reads.” Ex. 1003, 4:10–13. Yet, the claim does not use the exact wording used in the Specification.4 The ’241 patent goes on to disclose “apparent duplicates” and “true” slip op. at 14
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We do not see a material difference in the parties’ proposed levels of education and work experience. Indeed, although Petitioner asserts that a POSA “would have a PhD or equivalent training,” it allows more work experience to compensate for less education. Pet. 20 (stating that a POSA could have “commensurately less education and more work experience”). We, nevertheless, adopt Patent Owner’s proposal in this aspect because it specifies the years of experience needed. Patent Owner further disputes Petitioner’s proposal that a POSA would have had experience with “implementing and designing library preparation methods for Illumina, the leading NGS platforms in 2013.” Prelim. Resp. 7–8 (quoting Pet. 20, emphasis added by Patent Owner removed). According to Patent Owner, “[t]his level of skill inappropriately requires the POSA to be an inventor of library preparation methods.” Id. at 8. We agree with Patent Owner that “experience with implementing and designing library preparation methods for Illumina” is above ordinary skill. have had experience with DNA sequencing methods and a working knowledge of how these sequencing methods functioned.” Id. As Patent Owner recognizes, the challenged claims relate to obtaining amplicons with an amplified nucleic acid fragment and an appended adaptor and then sequencing the amplicon to generate sequence reads. See Ex. 1005, 25:33– 43. Accordingly, for purposes of this Decision, we find a person of ordinary skill in the art at the critical time would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. Alternatively, a person of ordinary skill in the art would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. The person of ordinary skill in the art would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a person of ordinary skill in the art is consistent with the skill level reflected in the disclosures of the ’241 patent and prior art. We further note that neither aspect of the dispute over the skill level affects our decision to institute review.” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,725,241 - PTAB · Mar 7, 2025 · IPR2024-01353 · APJ Tawen Chang · IPR · Institution
Instituted IPR of claims 1–20 on all asserted grounds; the Board found a reasonable likelihood of unpatentability over Kanan and Neri, with Famulok for claim 16.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314(a).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“On the current record, for purposes of this Decision, we apply 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 ’848 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)). We note, 8 “POSA” refers to “person of ordinary skill in the art.” Pet., cover page. experience indefinitely with no upper bound. Therefore, we do not apply this aspect of Petitioner’s definition. C. Claim Construction” slip op. at 10
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“As an initial matter, two criteria determine whether prior art is analogous: “(1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). We find that, at this stage of the proceeding, Petitioner has sufficiently shown that Kanan and Neri are and/or are reasonably pertinent to the problem which the inventor is involved, in particular “encoding individual members of a library of chemicals with unique nucleotide sequences that can later be detected and analyzed to determine the identification of the members involved in the interaction.” Pet. 17.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“argument does not undermine Petitioner’s challenge at this stage. In particular, Petitioner has explained that the modification of Kanan with Neri’s self-assembly sequence would “reduce the time to synthesize a library where all members can interact.” Pet. 18 (citing Ex. 1005 ¶¶ 97–101). Similarly, Petitioner has explained the reason for including a “coding region” for each library member, i.e., to “provide a unique nucleic acid identification sequence for each conjugate that can be identified downstream,” as for instance taught by Neri. Id. at 30 (citing Ex. 1005 ¶ 97). Finally, Petitioner has explained “a POSA . . . would . . . add the d-spacer taught in Neri, as this prevents the identification sequence element of pool B members from interacting with the identification sequence element of supports Petitioner’s contentions and that testimony is, at present, substantively unrebutted. On the record before us, and at this preliminary stage of the proceeding, we do not find Petitioner’s asserted motivations to be improperly disparate or based on hindsight. In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (explaining that reconstruction of prior art is not improper “so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure”). To the extent Patent Owner is also arguing that Petitioner’s assertions regarding reasonable expectation of success are unsupported, Prelim. Resp. 24, the argument is similarly unavailing. Petitioner has pointed to teachings in Neri and the knowledge of an ordinarily skilled artisan to support its assertions. Pet. 21–23 (citing, e.g., Ex. 1005 ¶¶ 104–105, 149, 171, 183 and Ex. 1011 ¶¶ 10, 82 to explain why an ordinarily skilled artisan would have reasonably expected success in applying, to Kanan’s small molecules, Neri’s “method of preparing organic molecules, peptides, and oligomeric proteins linked to an oligonucleotide that results in stable self-assembled associated oligonucleotides”). In this regard, we note that “the expectation of success need only be reasonable, not absolute.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007).” slip op. at 25
§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,883,848 - PTAB · Jan 23, 2025 · IPR2024-01157 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–9 across all petition grounds, finding a reasonable likelihood of success on at least one claim, including anticipation of claim 1 by Schaffer.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’011 patent’s challenged claims. We institute inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“We need not at this time expressly construe the term “filament” in the manner urged by Petitioner. We agree with Petitioner that a filament as claimed encompasses one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes. The ’011 patent lists those structures explicitly, but suggests those are only examples and, thus, the term “filament” may be broader than those structures. Ex. 1001, 9:18–20 (“In some embodiments, the filament 150 can comprise one or several threads, lines cords, rope, ribbon, flat wire, sheet, or tape.”) (emphasis added). As noted above, Patent Owner also does not disagree that the claimed “filament” encompasses the listed structures. We need only construe terms to the extent necessary to resolve the controversy. Realtime Data, 912 F.3d at 1375.” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching that every claim element was disclosed in that single reference.” Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991)) (emphasis omitted). “Because the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements arranged as in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (internal quotation marks omitted). slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“have been motivated to combine Schaffer and Hartley with a reasonable expectation of success. Pet. 35–40. For example, according to Petitioner, a POSA would have regarded a substitution of Schaffer’s U-shaped members for Hartley’s string as little more than a substitution of known hemostasis-valve features with known (and similar) functions to yield a predictable result. Pet. 35–36. Petitioner’s position is supported by Mr. Thornton’s testimony (unrebutted at present) that, in the field of fluid stasis valves, “[t]here were a finite number of ways to compress the resilient material in a stasis valve to create a seal in September 2017” and “Hartley and Schaffer disclose two such methods” that operate in similar and predictable ways to constrict the central lumen to form a seal. Ex. 1003 ¶¶ 82–83. We agree at this time that the proposed technique for coupling Hartley’s string to Schaffer’s actuator buttons would have been a “simple modification” within the ordinary capabilities of the skilled artisan. Id. ¶ 84 (noting a “simple” knotting attachment); see also Ex. 1007, 14:37–54 (suggesting skilled flexible wire to an actuator or housing of a fluid stasis valve). We also agree with Petitioner at this time that the POSA would have considered a more flexible filament (e.g., Hartley’s string or Eller’s wire) as providing expected benefits insofar as such a filament may more precisely and uniformly constrict the lumen against inserted tools of different sizes and shapes. Ex. 1006 ¶ 37 (Hartley’s string can “close over a range of diameters of devices passed through the valve or can close completely down and be self sealing”); Ex. 1003 ¶¶ 80–81.” slip op. at 36
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,697,011 - PTAB · Dec 16, 2024 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Institution
The Board instituted inter partes review of claims 1–8 on all asserted grounds, finding a reasonable likelihood that Barbour would render the challenged claims unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Anticipation by or Obviousness over Barbour Petitioner asserts that Barbour anticipates and/or renders obvious all challenged claims. Pet. 6, 41–67. Patent Owner does not dispute these assertions. Barbour is the published 2004 application and shares the same disclosure as the ’378 patent. Based on this record, we find Petitioner’s arguments on anticipation and/or obviousness persuasive. Thus, we determine Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of the challenged claims. We institute inter partes review of all challenged claims on all of the grounds in the Petition.” slip op. at 21
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledDecided for petitioner
“4. Summary In sum, based on the current record, and for purposes of this Decision, Petitioner has shown sufficiently that the disclosure of the 2004 application, by itself, fails to enable POSAs to practice the challenged claims without undue experimentation. In addition, Patent Owner has not shown that TC1507 was “known and readily available to the public” as of the filing date of the 2004 application. Therefore, the 2004 application does not enable the challenged claims, and the challenged claims are not entitled to the 2004 priority date. The earliest possible priority date for the challenged claims is, thus, July 6, 2007, which is the filing date of the 2007 application.” slip op. at 18
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“4. Summary In sum, based on the current record, and for purposes of this Decision, Petitioner has shown sufficiently that the disclosure of the 2004 application, by itself, fails to enable POSAs to practice the challenged claims without undue experimentation. In addition, Patent Owner has not shown that TC1507 was “known and readily available to the public” as of the filing date of the 2004 application. Therefore, the 2004 application does not enable the challenged claims, and the challenged claims are not entitled to the 2004 priority date. The earliest possible priority date for the challenged claims is, thus, July 6, 2007, which is the filing date of the 2007 application.” slip op. at 18
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artPrinted publication establishedDecided for petitioner
“Thus, the critical issue is not, as Patent Owner asserts, whether “the same application can be simultaneously enabling and not enabling.” Id. at 32. It is whether TC1507 was “known and readily available” to the public at the relevant time. As explained above, for the priority determination, the relevant time is April 30, 2004, the filing date of the 2004 application. Patent Owner has not produced or pointed to any evidence to show TC1507 corn “readily available” to the public without restrictions as of the filing date of the 2004 application. On the other hand, for prior-art status determination, the relevant time is February 16, 2006, the publication date of Barbour. Petitioner has presented sufficient evidence, which Patent Owner does not challenge, to show that, by 2006, corn harvested from TC1507 plants was “commercially available following the 2003, 2004, and 2005 growing seasons” and “[s]uch corn was sold as a commodity—without any contractual restrictions” Pet. 52 (citing Ex. 1007 ¶ 134). As a result, based on the current record, we find Petitioner has established sufficiently that, as of its publication date in February 2006, Barbour is prior art that would have enabled practice of the subject matter encompassed by the challenged claims.” slip op. at 20
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 8,901,378 - PTAB · Nov 8, 2024 · IPR2024-00834 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood of unpatentability and declining discretionary denial under §§ 325(d) and 314.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“anticipated by Sonti. Pet. 3. To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). The prior art need not, however, use the same words as the claims to find anticipation. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). In evaluating anticipation, it is permissible to take into account not only the literal teachings of the prior art reference, but also the inferences the skilled artisan would draw from it. Eli Lilly and Co. v. Los Angeles Biomedical Res. Inst. At Harbor-UCLA Med. Ctr., 849 F.3d 1073, 1074–75 (Fed. Cir. 2017) (holding that the “dispositive question regarding anticipation is whether one skilled in the art would reasonably understand or infer from a prior art reference that every claim element is disclosed in that reference”). As such, “a reference can anticipate a claim even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (internal quotation and alteration marks omitted).” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“b. Reasonable Expectation of Success Petitioner asserts that an ordinarily skilled artisan would have been motivated, with a reasonable expectation of success, to topically administer 1% tapinarof composition once a day to treat mild to severe plaque psoriasis in view of Sonti’s teaching to apply its compositions (including 1% tapinarof compositions) in various application frequencies (including once daily) to treat moderate to severe plaque psoriasis. Pet. 29–30 (citing, e.g., Ex. 1003 ¶¶ 182–184, 187–188; Ex. 1005 Abstract, ¶¶ 55, 196, 288, 387).” slip op. at 32
- Obviousness (§103) › Objective indicia / secondary considerationsInstituted
“d. Objective Indicia of Non-obviousness Patent Owner asserts that, although the “Petition notes the patent’s ‘surprising[] and unexpected[]’ finding that once daily application of 1% tapinarof cream was just effective as twice daily application, . . . the Petition does not analyze, as the law requires, this surprising, unexpected finding in its obviousness arguments.” Prelim. Resp. 52. We are not persuaded by this argument. Immediately after the Petition’s acknowledgement that “[t]he specification [of the ’088 patent] contends that it was ‘surprisingly’ found that once daily application was just as effective as twice daily,” the Petition notes that, “[h]owever, during prosecution the examiner cited a set of prior art by Chen et al. disclosing treating plaque psoriasis by topically applying a composition containing 1% tapinarof once a day.” Pet. 1 (footnote omitted). Indeed, Patent Owner acknowledges that Petitioner counters “Applicant’s surprising and unexpected findings” by referring to the Chen references cited during prosecution, but asserts that “Chen . . . does not undermine Applicant’s surprising and unexpected findings” because “Chen discloses applying a composition containing 1% mixture of cis and trans 3,5-dihydroxy-4-isopropylstilbene, and not one containing 1% tapinarof (3,5-dihydroxy-4-isopropyl-trans-stilbene).” Prelim. Resp. 52–53.16 As 16 Patent Owner refers to its earlier discussion on this issue. Prelim. Resp. 53 (“As already discussed . . .”). That earlier discussion is with respect to the Chen references cited in Sonti (i.e., Exs. 1012 & 1013), not the Chen 40” slip op. at 40
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,590,088 - PTAB · Jul 23, 2024 · IPR2024-00669 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–8 and 11, finding a reasonable likelihood of success on at least one claim under the Saadat grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. For reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’077 patent’s challenged claims. Also, we decline to deny the Petition on a discretionary basis. Therefore, we institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“As discussed below (Section IV.D), we determine at this stage that Saadat is prior art. There is no argument from Patent Owner that Saadat was presented previously to the Office. Pet. 96 (Petitioner’s unrebutted argument that Saadat was not previously considered by the Examiner). And, beyond the unsuccessful attempt to antedate and, thus, disqualify Saadat as prior art, at this stage of the proceeding Patent Owner offers no argument or evidence to rebut Petitioner’s contention that Saadat anticipates and renders obvious the ’077 patent’s claims under Grounds 1–3. See generally Prelim. Resp. 8–26 (Patent Owner’s priority date arguments). For the above reasons, we find that Patent Owner has not shown that substantially the same prior art or arguments (i.e., Saadat and arguments based thereon) were previously presented to the Office and, thus, Patent Owner has not satisfied step one of Advanced Bionics’ two-step framework. Advanced Bionics, Paper 6 at 8. On this record, even if we accept Patent Owner’s contentions about the Office’s prior consideration of Makower or Fang (art asserted under Grounds 5 and 6), we do not find that § 325(d) is sufficiently implicated based on our determination on the priority issue and Petitioner’s otherwise uncontested argument that the challenged claims are unpatentable over Saadat—issues we discuss in more detail below.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not propose an alternate definition of the POSA’s qualifications or contest Petitioner’s definition. See generally Prelim. Resp. We apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that, “[f]or purposes of this IPR, the Board need not construe any terms.” Pet. 18. Patent Owner similarly does not propose any express claim construction for any of the challenged claims at this time. See generally Prelim. Resp. and based on our review of the record, we determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Realtime Data, 912 F.3d at 1375.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,679,077 - PTAB · Jul 23, 2024 · IPR2024-00280 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1, 2, 5, 8–10, 12, and 14 on all petitioned grounds after finding a reasonable likelihood of success on at least one challenged claim.
RulingsInstitution decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“On the record before us, however, we do not discern how the specification of the ’011 patent provides written description support for the challenged claims. The challenged claims are purportedly directed to an apparatus for treatment of a nasal condition by altering nasopharyngeal cells in the target tissue such that nasal congestion is reduced. Ex. 1001, claim 1. As noted by Petitioner, the ’011 patent specification does not describe the use to energy to treat a nasal condition in the manner recited in the claims. Pet. 26–27. Rather, the ’011 patent specification discloses the use of neurotoxins to treat nasal conditions, and, more specifically, that neurotoxins are used to disrupt neural signals in the targeted tissue and, therein, disable mucus secretion by such tissues. Ex. 1001, 3:9–18, 8:6–13, 8:40–62, 21:43– 53.4 In the ’011 patent specification, energy is applied only to achieve cell membrane permeabilization or poration and effectuate the delivery of 4 The Specification describes, for instance, using botulinum toxin to block acetylcholine release from cells in the nasal membranes that are responsible for mucus hypersecretion even without energy-mediated delivery, but describing that use of energy to permeabilize the cells allows for more targeted delivery of the toxin. Ex. 1001, 21:43–53; 2:9–18 (explaining, as background, that acetylcholine is a neurotransmitter, the release of which is blocked by botulinum toxin); see also id. at 8:20–37 (disclosing that the “nasopharynx comprises a cluster of goblet cells which are responsible for mucus secretion and which are susceptible to the disabling mechanism of the botulinum toxin and other neurotoxins” and, further, by controlling the delivery area of the energy and toxin, “only those cells in the nasal membrane that are exposed to both the toxin and the applied energy will preferentially be permeabilized or porated to receive the toxin within the cytoplasm of the cell”). note that the challenged claims do not recite administering neurotoxins, but instead only require supplying energy “to alter nasopharyngeal cells in the target tissue such that nasal congestion is reduced.” Id. at claim 1.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“anticipated by Saadat. Pet. 32. In support of its assertion that Saadat anticipates the challenged claims, Petitioner provides a detailed discussion explaining how each claim limitation of claims 1, 2, 5, 8–10, 12, and 14 is disclosed by Saadat “arranged as in the claims.” Id. at 32–50 (citing Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1341 (Fed. Cir. 2016)). Petitioner’s contentions are supported by the declaration of Dr. Bu-Saba. Ex. 1002 ¶¶ 88–139. In particular, Petitioner contends that Saadat discloses an RF ablation probe in a nasopharyngeal passage of a patient for the ablation of a posterior nasal nerve. Id. at 33–46 (citing Ex. 1002 ¶¶ 88–124). Petitioner also contends that “Saadat explains its RF ablation alters nasopharyngeal cells to reduce or eliminate rhinitis symptoms, including congestion.” Id. at 43–44 (citing Ex. 1003, 3:6–14 (“Ablating [posterior nasal] nerves leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea in patients with chronic rhinitis (allergic or vasomotor).”), 16:44–51; Ex. 1002 ¶¶ 117–118). Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing, which we find sufficient for institution purposes. See generally Prelim. Resp. Rather, Patent Owner contends Saadat is not prior art because the ’011 patent is entitled to rely upon the July 21, 2006, filing date of the ’090 application. Id. at 24. For the reasons effective filing date no earlier than October 22, 2019. Saadat is a U.S. patent that issued June 4, 2019, from a nonprovisional application filed May 17, 2018. Thus, under 35 U.S.C. § 102(a)(1), Saadat qualifies as prior art to the challenged claims. In view of the foregoing, we determine that Petitioner has established a reasonable likelihood of showing that Saadat anticipates at least one of the challenged claims of the ’011 patent. Accordingly, we institute an inter partes review of claims 1, 2, 5, 8–10, 12, and 14 of the ’011 patent.” slip op. at 36
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Whether a skilled artisan would have been motivated to combine the art’s teachings with a reasonable expectation of success in arriving at the claimed subject matter is a fact-intensive inquiry. Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”); Par Pharm., Inc. v. TWi Pharma., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014) (“The presence or absence of a reasonable expectation of success is also a question of fact.”). Petitioner supports its challenge with evidence-backed reasoning, including the testimony of Dr. Bu-Saba, and Patent Owner’s responsive attorney argument is unavailing at this stage. See, e.g., Ex. 1002 ¶¶ 169–170 (testifying, inter alia, that Makower and Fang both teach applying RF energy to the nasopharyngeal passage to disrupt nerves and treat rhinitis, with Makower detailing an electrosurgical device and uses thereof and Fang elaborating on a therapeutic result that would be expected from use of such a device, thus suggesting the skilled artisan’s consideration of the art’s combined teachings). We will revisit Petitioner’s asserted reasons for combining Makower and Fang as appropriate on a fully-developed record. At this stage, however, Petitioner has put forth sufficient evidence and reasoning to meet its institution burden and proceed to trial, especially as we have already” slip op. at 40
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Patent Owner argues that we should exercise our discretion under 35 U.S.C. § 325(d) to deny institution because the same or substantially the same prior art or arguments previously were presented to the Office. Prelim. Resp. 27–35. On this record, even if we agreed with Patent Owner’s contentions about the Office’s prior consideration of Makower, Fang, or Edwards (the Ground 4 art), we do not find that § 325(d) is sufficiently implicated based on our determination on the priority issue as explained above and Petitioner’s otherwise uncontested argument that the challenged claims are unpatentable over Saadat. Discretionary denial of the entire petition is, thus, unjustified.” slip op. at 39
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,894,011 - PTAB · Jul 23, 2024 · IPR2024-00279 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claims 1–3, 7, 9, 10, and 17–25 on all petitioned grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–3, 7, 9, 10, and 17–25 of the ’675 patent are unpatentable.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Specification of the ’675 patent provides written description support for the challenged claims. The challenged claims are purportedly directed to treating a nasal condition comprising “delivering energy to the target tissue” to reduce mucus secretion or congestion. Ex. 1001, claims 1 and 17. As noted by Petitioner, the ’675 patent Specification does not describe the use to energy to treat a nasal condition in the manner recited in the claims. Pet. 24–25. Rather, the ’675 patent Specification discloses the use of neurotoxins to treat nasal conditions, and, more specifically, that neurotoxins are used to disrupt neural signals in the targeted tissue and, therein, disable mucus secretion by such tissues. Ex. 1001, 3:25–34, 8:18–21, 8:38–60, achieve cell membrane permeabilization or poration and effectuate the delivery of neurotoxin into to target cells. See, e.g., id. at 4:49–51, 8:4–21. Here, we note that the challenged claims do not recite administering neurotoxins, but instead only require the delivery of energy to the target tissue to administer therapy.” slip op. at 16
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“probe in a nasopharyngeal passage of a patient for the ablation of a posterior nasal nerve. Id. at 30 (citing Ex. 1002 ¶¶ 85–99). Petitioner also contends that “Saadat explains that RF ablation disrupts neural activity to reduce or eliminate rhinitis symptoms, including mucus secretion and congestion.” Id. at 36 (citing Ex. 1003, 3:6–14 (“Ablating [posterior nasal] nerves leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea in patients with chronic rhinitis (allergic or vasomotor).”), 16:44–51; Ex. 1002 ¶ 103). Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing, which we find sufficient for institution purposes. See generally Prelim. Resp. Rather, Patent Owner contends Saadat is not prior art because the ’675 patent is entitled to rely upon the July 21, 2006, filing date of the ’090 application. Id. at 24. For the reasons discussed above, we determine that the Specification of the ’675 patent fails to provide adequate written description support for the challenged claims, and thus, the challenged claims are entitled to an effective filing date no earlier than October 22, 2019. Saadat is a U.S. patent that issued June 4,” slip op. at 33
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,610,675 - PTAB · May 28, 2024 · IPR2024-00170 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR of claims 1–13 on all five 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
“In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“According to Patent Owner, Petitioner’s proposed definition “attempts to imbue the POSA with an array of different skills and competencies that do not accurately reflect the state of the field at the time of the October 2014 priority date.” Prelim. Resp. 10. Patent Owner does not offer a competing definition in the Preliminary Response, but notes that we adopted the above definition in the 00224, 00317, 00545, and 00546 IPRs. Insofar as the prior art of record appears to support Petitioner’s definition, we apply our earlier definition here as Petitioner urges. 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)). Patent Owner is, nevertheless, welcome to provide argument and evidence for an alternative definition at trial.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). On its face, the preamble of claim 1 includes a “wherein” clause requiring that the biological sample be obtained “from a non-fetal source.” Because Petitioner does not explain how this limitation is either understood from the body of the claim, or severable from the remainder of the preamble, we do not find Petitioner’s argument persuasive. See Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1355 (Fed. Cir. 2020) (“A conclusion that some preamble language is limiting does not imply that other preamble language, or the entire preamble, is limiting.”). Absent further argument and evidence, and solely for the purpose of this Decision, we construe the preamble as limiting. slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Specification provides little guidance regarding how much of the genome must be sequenced under Patent Owner’s construction. See generally 00224 IPR, Paper 11 at 19–23. As discussed in detail on pages 15–16 of the Preliminary Response, however, the instant Specification does make a clear distinction between “untargeted sequencing (e.g., whole genome sequencing)” as compared to targeted sequencing approaches such as “whole exome sequencing,” or “deep sequencing over a fraction of the genome.” See e.g., Ex. 1001, 17:36–49, 25:64–34, 27:16–19, 43–46; cf. 00224 IPR, Paper 11 at 22 (“tak[ing] particular note of the [’394] Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35– 58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42)”). As we read the Specification, the phrase “sequencing all or almost all of a genome,” speaks more tot the untargeted nature of the process rather than to an end result of the sequencing effort. In this respect, the instant Specification’s references to “high coverage whole genome sequencing,” “low coverage whole genome sequencing,” and “low” and “zero mean coverage regions from WGS,” indicate that whole genome sequencing does not mean that all or almost all of the nucleotide bases in a genome must be determined, but that “all or almost all” of the genome is available for sequencing.12 See e.g., id. at 25:64–67, 26:6–14, 27:16–19, 28:57–60; 32:37–45; see also 00224 IPR, Paper 11 at 19–23 (preliminarily determining that Leary disclosed whole genome sequencing despite evidence that the authors sequenced only about half of the genome). With the above explanation, we provisionally construe “whole genome sequencing as “a non-targeted approach to sequencing all or almost all of a genome.” We leave for later, and to the extent necessary, any 12 Consistent with Owner’s argument that “WGS has taken on many different flavors of meaning,” we presently understand the Specification’s recognition of “high” and “low” coverage whole genome sequencing as species of the generic term. See Prelim Resp. 12–13 (citing Ex. 2018, 155:15–20, 161:21–162:1, 156:20–157:22). determination of the lower limit (if any) one of ordinary skill would attach to the number sequencing reads, extent of genomic coverage, or nucleotide bases that must be determined to qualify as whole genome sequencing, and whether any particular experimental approach would have been understood to comprise whole genome sequencing.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,584,968 - PTAB · May 14, 2024 · IPR2024-00193 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–6 and 9 on all petitioned grounds, finding a reasonable likelihood of prevailing on the obviousness challenges and declining discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’868 patent’s challenged claims. We decline to deny the Petition on a discretionary basis. We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“pending lawsuit involving the challenged patent, the Board considers six non-exclusive factors set forth in Fintiv. Fintiv, Paper 11 at 6. The Director of the USPTO has, however, clarified the Board’s application of the Fintiv factors according to an “Interim Procedure” established June 21, 2022. Interim Procedure For Discretionary Denials In AIA Post-Grant Proceedings With Parallel District Court Litigation, issued June 21, 2022 (“Interim Procedure”).6 The Interim Procedure explains that, “[c]onsistent with Sotera Wireless, Inc., the PTAB will not discretionarily deny institution in view of parallel district court litigation where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB.” Interim Procedure 2– 3 (internal footnote omitted) (citing Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A) (“Sotera”)). The Interim Procedure also indicates that a Sotera-type stipulation “mitigates concerns of potentially conflicting decisions and duplicative efforts between the district court and the PTAB . . . [and] allows the PTAB to review grounds that the parallel district court litigation will not resolve.” Id. at 7–8.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“encountered in the art, the art’s solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims’ language in accordance with its ordinary and customary meaning as understood by the POSA, in view of the patent’s specification and considering the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only to the extent needed to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019); U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (holding claim construction is for “resolution of disputed meanings”).” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,143,868
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.