- Ascentcare Dental Product, Inc. v. Solmetex, LLCInstitution deniedPTAB · Dec 12, 2025 · IPR2025-01175 · APJ James A Tartal · IPR · Institution
The Board denied institution because Petitioner did not sufficiently show the patent was eligible for IPR when it filed the petition less than two months after issuance.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“We determine that Petitioner cannot credibly certify that the ’418 patent is available for inter partes review, based on a claim of priority on the face of the ’418 patent to the ’939 provisional application filed prior to the effective date of the AIA, where, as here, Petitioner contradictorily contends in the Petition that the ’939 provisional application “does not support all claim limitations” of the ’418 patent.4 Id. If Petitioner’s allegation that claims of the ’418 patent are not supported by the ’939 provisional application is correct, then the ’418 patent would be a post- AIA patent for which a petition may not be filed earlier than 9 months after the ’418 patent issued. See 35 U.S.C. § 311(c). Thus, based on the arguments and evidence presented by Petitioner, Petitioner fails to show that the ’418 patent is eligible for inter partes review when Petitioner filed the Petition less than two months after the ’418 patent issued. 35 U.S.C. § 311(c), 37 C.F.R. § 42.102(a)(1). We, therefore, deny the Petition. IV. CONCLUSION For the foregoing reasons, we find that Petitioner has not shown sufficiently that the Petition complies with 35 U.S.C. § 311(c) and, therefore, deny the Petition.” slip op. at 10
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportNot reached
“review when the Petition was filed “because the ’418 Patent claims priority to December 7, 2012 and is therefore,” not a post-AIA patent. Pet. 17 (emphasis added). Contrary to Petitioner’s assertion, the ’418 patent is a post-AIA patent if any claim of the ’418 patent does not have priority to the ’939 provisional application, regardless of whether, on its face, the ’418 patent “claims priority” to an application filed prior to the effective date of the AIA. See In re NTP, Inc., 654 F.3d 1268, 1276–77 (Fed. Cir. 2011) (“[A] patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority.”).” slip op. at 9
§ 102 anticipationPatents in suitUS 12,290,418 - Azurity Pharmaceuticals, Inc. v. Exelixis Inc.Institution deniedPTAB · Jun 4, 2025 · IPR2025-00210 · APJ Jeffrey N Fredman · IPR · Institution
The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving claims 1–3 unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that the combination of Brown, Kubo, and Remington would inherently result in less than 200 ppm impurity and Petitioner has not shown that it has a reasonable likelihood that it would prevail on the obviousness ground.” slip op. at 29
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“Here, there is no dispute that the ’349 patent and Wilson, which issued from a patent application from which priority was claimed for the ’349 patent, share the identical disclosure of a pharmaceutical composition comprising Compound IA or IB; one or more fillers; one or more disintegrants; one or more glidants; and one or more lubricants. In this embodiment, the filler comprises microcrystalline cellulose. In this embodiment, the disintegrant comprises croscarmellose sodium. In this embodiment, the disintegrant comprises croscarmellose sodium and sodium starch glycolate. In this embodiment, the glidant comprises fumed silica. In this embodiment, the lubricant comprises stearic acid. Ex. 1001, 21:1–12; Ex. 1002, 20:51–62. There is express ipsis verbis disclosure of the elements recited in claim 1 of the ’349 patent.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“1. Reason to reduce contaminant levels We agree with Patent Owner that Petitioner identifies no teaching in the prior art providing any reason to reduce levels of 6,7-dimethoxy-quinoline-4-ol specifically. And while Brown does teach a desire to form “substantially pure” compounds, Brown focuses on “at least about 90 wt.%” of the compound, then lists specifically “about 90, about 91, about 92, about 93, about 94, about 95, about 96, about 97, about 98, about 99 and about 100% wt. %.” Ex. 1003 ¶ 97. This permits a range of concentration for contaminants from about 0 to 10%.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“to modify Brown’s process with Kubo to eliminate the added step. See, e.g., Id. ¶ 73. But even with that combination, Dr. Dichtel states only that a “POSA would have expected there to be a decrease in the amount of 6,7- dimethoxy-quinoline-4-ol at the end of cabozantinib (L)-malate’s synthesis that was attributable to hydrolytic degradation of the 4- (nitrophenoxy)quinoline intermediate by avoiding its use in the synthesis.” Id. ¶ 78. That is not, however, the standard for inherency. It must be the necessary result, not a possible expected result. The Federal Circuit in Par explained that: Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” slip op. at 28
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,349 - Aardevo North America, LLC v. Agventure B.V.Institution deniedPTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution
Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable
“Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,140,841 - Imperative Care, Inc. v. Inari Medical, Inc.Institution deniedPTAB · Feb 7, 2025 · IPR2024-01257 · APJ Timothy G Majors · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving any challenged claim unpatentable, chiefly because Garrison did not disclose the claimed negative-pressure arrangement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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. Based on the record here and for the reasons discussed below, we find that Petitioner has not demonstrated a reasonable likelihood that it will prevail in establishing that any of the challenged claims are unpatentable. We, therefore, do not institute inter partes review.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need only construe the claims to the extent needed to resolve the controversy before us. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). Patent Owner neither disputes Petitioner’s proffered construction nor disputes Petitioner’s contention that Hartley teaches a “filament” as claimed. See, e.g., Pet. 41–43; Prelim. Resp. 17. We need not expressly construe the term “filament” or any other term for this Decision.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner proposes that the person of ordinary skill in the art (“POSA”) in August 2018 “would have had an undergraduate degree in mechanical engineering or a related engineering discipline and 2–4 years of catheter design experience.” Pet. 20 (citing Ex. 1003 ¶¶ 35–36). Patent Owner contends that Petitioner’s proposal is “insufficient,” yet Patent Owner provides no alternative definition of the POSA’s qualifications and, instead, applies Petitioner’s proposed definition. Prelim. Resp. 17. We apply Petitioner’s proposed POSA level for the purposes of this Decision, which level does not appear to be inconsistent with the prior art of record.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableInstitution denied
“On this record, we agree with Patent Owner that Petitioner has not shown sufficiently that Garrison describes the subject matter of claim 1’s system with the subject matter being arranged as recited in the claim. Prelim. Resp. 44–62. Patent Owner argues, for example, that Petitioner “fails to identify any embodiment of Garrison that discloses . . . an aspiration system including an aspiration pump in which negative pressure is generated in a first chamber and a second chamber when a valve is closed.” Id. at 45. Patent Owner cites, inter alia, Petitioner’s identification of “an aspiration pump that is positioned upstream of a receptacle such that the pump delivers fluid (e.g., blood) to the receptacle via positive pressure and thus cannot generate negative pressure in the receptacle”—the alleged “first chamber” identified by Petitioner. Id. at 45–46 (emphasis added). Patent Owner persuasively supports its counterarguments with the teachings of Garrison and the testimony of Mr. Brown. See, e.g., Ex. 1006, Figs. 32–36; Ex. 2001 ¶¶ 64–76. We discuss in further detail below. whenever Garrison discloses a pump in the embodiments identified by Petitioner—whether a peristaltic pump as shown in Figures 32–34, a centrifugal pump, or the pump device 3250 shown in Figure 36—the pump is positioned to draw fluid through an inlet and expel the fluid out of an outlet via positive pressure to a downstream delivery location such as a receptacle or blood return line. Such a pump would not and could not generate negative pressure in the downstream delivery location (the receptacle the Petition alleges is the first chamber) for multiple reasons—and therefore would not generate negative pressure in any “first chamber” identified by Petitioner. Prelim. Resp. 46. We agree with Patent Owner.” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,744,691 - Vectair Systems Inc. v. Fresh Products, Inc.Institution deniedPTAB · Nov 12, 2024 · IPR2024-00824 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution on all challenged claims because the Petition did not establish that the listings were prior art or provide sufficient evidence and motivation for the obviousness combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, Preliminary Response, and information presented by the parties, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we decline to institute inter partes review.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“of claims under 35 U.S.C. § 102 or § 103 “only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). At the institution stage, the “burden is on the petitioner to identify with particularity evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent, and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 21 (PTAB Dec. 20, 2019) (precedential). This differs from the standard in a final written decision, at which point “the petitioner bears the burden of establishing by a preponderance of the evidence that a particular document is a printed publication.” Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1375 (Fed. Cir. 2018) (citing Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018)).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“c. Discussion Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner fails to establish a reasonable likelihood that the Amazon Listings were publicly accessible before the priority date of the ’098 patent, and therefore fails to establish a reasonable likelihood that the Amazon Listings qualify as printed publications. As explained in a previous Board decision, “[t]he date that a product was listed as first available on a website . . . is not sufficient evidence that the content of the listing, including the photographs depicted therein, were published at that time.” Next Step Grp., Inc. v. Deckers Outdoor Corp., No. IPR2024-00525, 2024 WL 3678413, at *5 (P.T.A.B. Aug. 6, 2024) (citing Ex parte Basulto, Appeal 2020-00129, 2021 WL 1264902, at *2 (PTAB Apr. 2, 2021) (stating “the date [a] product was listed on Amazon.com is not compelling evidence that the content of [the] listing itself as shown in the document, and the photographs relied on within it were published at that time”). That is because product listings may be updated and photographs of the products may change over time and, therefore, a statement on a commercial website as to when a product was “first available” is insufficient evidence without additional corroborating evidence that the listing itself, or any photograph depicted therein, has not changed over time. See id. (citing Ex parte Zhang, Appeal 2021-000087, 2021 WL 633718 at *3 (PTAB Feb. 16, 2021) (stating “while the [webpage] date indicates that the product information was last updated on [date], there is no additional evidence to corroborate that the picture was publicly accessible on that date”)). In this case, Petitioner does not provide sufficient corroborating evidence that any of the information or images depicted in the Amazon Listings were available and remained unchanged on the website prior to the critical date. In contrast, Patent Owner provides evidence in the form of testimony of Mr. Smith, which we find credible, that the Amazon Listings offering the Wave 3D Urinal Screen for sale could not have existed prior to November 2014, the priority date of the ’098 patent. d. Conclusion In view of the above, we determine that, on this record, Petitioner has not established a reasonable likelihood of prevailing in demonstrating the unpatentability of claims 1, 19, and 38 with respect to Ground 1.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“b. Legal Standard “To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Moreover, “[a] party seeking to invalidate a patent on the basis of obviousness must demonstrate by clear and convincing evidence 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 Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012) (quotation marks omitted); see also In re Nuvasive, Inc., 842 F.3d 1376, 1383 (Fed. Cir. 2016) (explaining that “conclusory statements” are “insufficient articulations of motivation to combine” prior art references). When an assertion of obviousness “fails to identify any actual reason why a skilled artisan would have combined the elements in the manner claimed,” the assertion of obviousness “is inadequate.” See In re Van Os, 844 F.3d 1359, 1361 (Fed. Cir. 2017). Furthermore, unsupported statements that a combination of elements would have been merely a design choice is insufficient to establish obviousness. See Stryker Corp. v. Karl Storz Endoscopy–America, Inc., IPR2015–00677, Paper 15 at 37 (P.T.A.B. Sept. 2, 2015) (“[t]he mere recitation of the words ‘common sense’ or ‘design choice,’ however, without any evidentiary support, adds nothing to the obviousness equation.” (citing Mintz v. Dietz & Watson, Inc., 679 F. 3d 1372, 1377 (Fed. Cir. 2012)).” slip op. at 17
§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,145,098 - Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Institution deniedPTAB · May 17, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that any challenged claim was unpatentable over Perkins or the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has not shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Accordingly, we deny institution of post-grant review.” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for patent owner
“Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that Perkins is prior art to the ’366 patent only to the extent that the subject matter disclosed in Perkins is likewise described in the Perkins Provisional. Accordingly, we do not consider Petitioner’s arguments that rely on subject matter unsupported by the Perkins Provisional. For example, support for Petitioner’s argument that Perkins discloses “mutant VSV-G envelope protein containing only four mutations at N180, I182, T352, and E353” is not found in the Perkins Provisional and is therefore not considered. Pet. 73 (quoted with Petitioner’s emphasis). Thus, insofar as Petitioner is suggesting that Perkins describes a list of mutations that is narrowed to four positions including a mutation at I182, rather than a listing of thirteen potential positions for mutations (and various combinations thereof with hypothetical mutations at a variety positions), we find no such narrower listing in the Perkins Provisional. Compare Ex. 1005, 22:2–5, with Ex. 1006, 17–18.” slip op. at 19
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“genus even if the species are not themselves recited.” Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001); see also, Atofina, 441 F.3d at 999 (“[A] very small genus can be a disclosure of each species within the genus.” (citing In re Petering, 301 F.2d at 682)). In Petering, for example, the prior art disclosed a small genus of only 20 compounds that included the claimed species. In re Petering, 301 F.2d at 682. In its discussion concluding that a small genus may anticipate a species of that genus, the Court of Customs and Patent Appeals explained that “it is not the mere number of compounds in this limited class which is significant here, but rather, the total circumstances involved, including such factors as the limited number of variations for R, only two alternatives for Y and Z, no alternatives for the other ring positions, and a large unchanging parent structural nucleus.” Id. at 681–682. Having considered the parties’ positions and evidence of record, summarized above, we do not find that Perkins discloses a limited class as exemplified in Petering. To begin, while it is undisputed that Perkins discloses a class of mutant VSV-G envelope proteins that encompasses the recited I182E or I182D mutations, it is also undisputed that Perkins does not disclose the I182E or I182D mutations. Prelim. Resp. 22. Furthermore, and by contrast to the limited class of compounds at issue in Petering, Perkins discloses a class of mutant VSV-G envelope proteins defined as proteins containing one or more of 20 possible mutations or alterations, a class that includes at least 254 proteins. Ex. 1006, 17–18; Prelim. Resp. 26–27. Furthermore, as Patent Owner correctly points out, “[t]he Perkins Provisional does not include any disclosure of the specific mutations to be made at any of these locations. That is, the Perkins Provisional does not indicate the other amino acid(s) to be substituted at the listed locations.” Prelim. Resp. 26. Thus, Perkins fails to provide a POSA with a “‘pattern of preferences’ that serves to narrow the genus.” See, e.g., Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1377 (Fed. Cir. 2006) (“there is no such clear ‘pattern of preferences’ [as found in Petering] that serves to narrow the genus in claim 2 to a narrow class that includes clopidogrel bisulfate”).” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Obviousness is a question of law based on underlying findings of fact.” In re Kubin, 561 F.3d 1351, 1355 (Fed. Cir. 2009). A conclusion of obviousness is appropriate where the prior art “contain[s] detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” In re O’Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988); see also, In re Kubin, 561 F.3d at 1359 (KSR “actually resurrects [the Federal Circuit]’s own wisdom in In re O’Farrell”). However, to render a claim obvious, prior art cannot be “vague” and must collectively, although not explicitly, guide an artisan of ordinary skill towards a particular solution. Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341, 1347 (Fed. Cir. 2009). That is, when a field is “unreduced by direction of the prior art,” and when prior art gives “no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful,” an invention is not obvious. Bayer Schering, 575 F.3d at 1347 (citing In re O’Farrell, 853 F.2d at 903). Having considered the parties’ positions and evidence of record, summarized above, we are not persuaded that Perkins discloses a finite set or limited class of 19 mutations. Pet. 66. Rather, we agree with Patent Owner that Perkins discloses a large genus of mutant VSV-G polypeptides containing at least 254 species—“Perkins Provisional discloses mutations at I182 among a group of 20 other possible locations for modifications[,] . . . [13] of these 20 positions are specific amino acids that . . . can be changed to any of the 19 other natural amino acids” —each species combinable to create a vast number of species. Prelim. Resp. 32. Perkins does not indicate any preference among the 13 disclosed mutations, does not indicate any preference among the 19 other amino acids, and does not indicate any preference as to which mutations should be combined to successful effect. Ex. 1006, 17–18. Thus, while Perkins discloses that one or more mutations “inhibit the envelope protein’s ability to bind its native target, while preserving the envelope protein’s fusogenic properties,” beyond that, a POSA would have no direction for selecting the route to create the I182E or I182D mutations specified by the challenged claims among the various unpredictable alternatives suggested by Perkins. Ex. 1006 at 16; Ex. 1002 ¶ 193. We do not find this to be the easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness. KSR, 550 U.S. at 402. slip op. at 34
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 11,767,366 - PTAB · Nov 21, 2023 · PGR2023-00026 · APJ Susan L C Mitchell · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that claims 1–19 were unpatentable, including because the proposed prior-art combination lacked a sufficient reason to select Ruminococcus for skin …
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”1 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“7 Patent Owner requested that we exercise our discretion to deny institution under 35 U.S.C. § 325(d). See Prelim. Resp. 11–49. Because we determine on the merits that no post-grant review should be instituted, we will not address Patent Owner’s arguments concerning Section 325(d).” slip op. at 44
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner counters that Petitioner has set the level of skill of a person of ordinary skill in the art too low. Prelim. Resp. 9–11; Ex. 2001 ¶ 25. Patent Owner asserts that a POSA would have a more advanced degree than a bachelor of science and would have more specific work experience. Id. For instance, Patent Owner asserts: A POSA for the ’838 Patent typically would have an advanced degree, such as an M.D. or a Ph.D., with experience and training in oncology, have several years of experience with administering oncology treatments to subjects and evaluating results of such treatments, and have experience or knowledge in microbiome science and its modulation, inclusive of studies that involve stool microbiome profiling, as well as experience in, or knowledge of, related research and development of bacterial-based cancer treatments. A POSA may also have worked as part of a multi-disciplinary team and drawn upon not only his or her own skills, but also taken advantage of certain specialized skills of others in the team, to solve a given problem. For example, such a team may include a clinician, an immunologist, microbiologist, bioinformatician, molecular biologist, manufacturing specialist, and/or pharmaceutical formulator. Prelim. Resp. 9–10 (citing Ex. 2001 ¶¶ 26–27). Patent Owner concludes that by applying the inappropriately low level of skill of a POSA, “Petitioner overstates the amount of guidance needed in the specification to describe and enable the claimed methods.” Prelim. Resp. 11. Patent Owner confirms, however, that all arguments on all grounds presented in the Preliminary Response “apply regardless of which party’s POSA definition is used.” Prelim. Resp. 11 n.2. We disagree with Patent Owner that a POSA is required to have a” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“Patent Owner acted as its own lexicographer and expressly defined “isolated” and “purified” as follows. The term “isolated” encompasses a bacterium or other entity or substance that has been (1) separated from at least some of the components with which it was associated when initially produced (whether in nature or in an experimental 6 Available at https://www.uspto.gov/sites/default/files/documents/IndefinitenessMemo.pd f?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email& utm_name=&utm_source=govdelivery&utm_term=. setting), and/or (2) produced, prepared, purified, and/or manufactured by the hand of man. Isolated bacteria may be separated from at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or more of the other components with which they were initially associated. In some embodiments, isolated bacteria are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. As used herein, a substance is “pure” if it is substantially free of other components. The term “purify,” “purifying” and “purified” refer to a bacterium or other material that has been separated from at least some of the components with which it was associated either when initially produced or generated (e.g., whether in nature or in an experimental setting), or during any time after its initial production. A bacterium or a bacterial population may be considered purified if it is isolated at or after production, such as from a material or environment containing the bacterium or bacteria population, and a purified bacterium or bacterial population may contain other materials up to about 10%, about 20%, about 30%, about 40%, about 50%, about 60% about, 70%, about 80%, about 90% or above about 90% and still be considered “isolated.” In some embodiments, purified bacteria and bacterial populations are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. In the instance of bacterial compositions provided herein, the one or more bacterial types present in the composition can be independently purified from one or more other bacteria produced and/or present in the material or environment containing the bacterial type. Bacterial compositions and the bacterial components thereof are generally purified from residual habitat products. Ex. 1001, 28:40–29:11. In reviewing the express definitions of “isolated” and “purified,” it is not surprising that the two similar terms, “isolated” and “purified,” may have overlapping definitions. We agree with Patent Owner that such overlap does not mean the definitions lack “reasonable clarity, deliberateness, and precision” that would inform a POSA with reasonable certainty about the scope of claim 1. We also agree with Patent Owner that a POSA would understand the two parts of the definition of “isolated” set forth above.” slip op. at 30
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · NautilusPatents in suitUS 11,395,838 - Novartis Gene Therapies, Inc. / Novartis Pharmaceuticals Corporation v. Genzyme CorporationInstitution deniedPTAB · Aug 30, 2023 · IPR2023-00609 · APJ James A Tartal · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 5 or 6 were unpatentable over either asserted obviousness combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2021). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (stating that the decision whether to institute inter partes review requires “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“show a reasonable likelihood of prevailing in its assertion that the aggregate limitations were inherently taught by the asserted art. Pet. 38–43; Prelim. Resp. 34–36. To prove inherency in the context of obviousness, a party must “meet a high standard” and establish that “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195–96 (Fed. Cir. 2014).” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Fourth, we find insufficient and not persuasive Petitioner’s conclusory assertions that “only routine optimization” with a reasonable expectation of success in light of the asserted art would have been required to obtain a optimization would be required to obtain an average AAV Rh <20nm using the obvious variants of Liu’s Example 17 composition”) (citing Ex.1025 ¶¶ 320–322), 43 (“only routine optimization would be required to improve AAV recovery following filtration of Liu’s modified Example 17 composition through a 0.22μm filter”) (citing Ex. 1025 ¶¶ 326–329). Petitioner offers scant evidence or explanation of what “optimization” was necessary, or why it would have been obvious to do so at the time of the invention. See Pet. 40 (“To the extent modifications to Lin’s composition” would have been “required to achieve the features of claim 5,” a person of ordinary skill in the art “would have been motivated to make such changes”) (emphasis added). Petitioner then suggests “such changes” are merely “optimization of known stabilization factors.” Id. Neither the Petition nor Dr. Amiji on behalf of Petitioner adequately explains what such optimization would have entailed or whether it would have been within the ability of a person of ordinary skill in the art at the time of the invention. See Ex. 1025 ¶ 319 (referring to “known aggregation reduction tools” without citation to any supporting prior art and asserting Liu taught “reducing potential aggregation by addition of surfactants”). In regard to the alleged expectation of success, we also find persuasive the testimony of Dr. Davies who notes that a person of ordinary skill in the art would have understood that “rAAV undergoes concentration-dependent aggregation,” and that the “nature of the interparticle interactions that result in aggregation has not been well characterized.” Ex. 2004 ¶¶ 97, 100 (quoting Ex. 1007, 17, 176).” slip op. at 22
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“show a reasonable likelihood of prevailing in its assertion that the aggregate limitations were inherently taught by the asserted art. Pet. 38–43; Prelim. Resp. 34–36. To prove inherency in the context of obviousness, a party must “meet a high standard” and establish that “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195–96 (Fed. Cir. 2014).” slip op. at 21
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,051,542 - Ideavillage Products Corp. v. Koninklijke Philips N.VInstitution deniedPTAB · Oct 25, 2022 · IPR2022-00904 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution on the sole claim, finding the obviousness challenges inadequate and exercising discretion to deny the marginal anticipation challenge.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“An obviousness analysis involves two steps; first, “one must find a single reference, a something in existence, the design characteristics of which are basically the same as the claimed design”; second, “once this primary reference is found, other references may be used to modify it to create a design that has the same overall visual appearance as the claimed design.” High Point Design, 730 F.3d at 1311 (internal quotation and citations omitted). Even when secondary references are not used, however, the analysis still requires an explanation as to how and why the primary reference (something having design characteristics basically the same as the claimed design) would have been modified to arrive at a design that has the same overall visual appearance as the claimed design. See, e.g., In re Nalbandian, 661 F.2d at 1217 (involving single-reference obviousness rejection and addressing the differences between the reference and the claimed design); In re Lamb, 286 F.2d 610, 611 (CCPA 1961) (affirming the Board in a case involving a single-reference obviousness rejection where “the board observed that it is conventional to use relatively slimmer handles with slim blades and that therefore, ‘it would be expected that a designer skilled in the cutlery art would use a somewhat narrower or slimmer handle with a slim blade’”). None of the 42 obviousness challenges advanced in the Petition is supported by an adequate analysis of those two steps. See id. at 64–88. In particular, none sufficiently discusses both the differences between the been modified (alone or in view of any other reference) to have the same visual appearance as the claimed design. Id.” slip op. at 12
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“An obviousness analysis involves two steps; first, “one must find a single reference, a something in existence, the design characteristics of which are basically the same as the claimed design”; second, “once this primary reference is found, other references may be used to modify it to create a design that has the same overall visual appearance as the claimed design.” High Point Design, 730 F.3d at 1311 (internal quotation and citations omitted). Even when secondary references are not used, however, the analysis still requires an explanation as to how and why the primary reference (something having design characteristics basically the same as the claimed design) would have been modified to arrive at a design that has the same overall visual appearance as the claimed design. See, e.g., In re Nalbandian, 661 F.2d at 1217 (involving single-reference obviousness rejection and addressing the differences between the reference and the claimed design); In re Lamb, 286 F.2d 610, 611 (CCPA 1961) (affirming the Board in a case involving a single-reference obviousness rejection where “the board observed that it is conventional to use relatively slimmer handles with slim blades and that therefore, ‘it would be expected that a designer skilled in the cutlery art would use a somewhat narrower or slimmer handle with a slim blade’”). None of the 42 obviousness challenges advanced in the Petition is supported by an adequate analysis of those two steps. See id. at 64–88. In particular, none sufficiently discusses both the differences between the been modified (alone or in view of any other reference) to have the same visual appearance as the claimed design. Id.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)
“Specifically, on that crucial issue, Mr. Peyser testifies “that the multiple perspective views are informative enough to prov[id]e me an understanding of what the front and rear views of the shaver head would look like.” Ex. 1003 ¶ 60 (emphasis added). Mr. Peyser neither explains why the perspective views are sufficient to disclose the missing front and rear views of the Philips OneBlade shaver head, nor keys his testimony, with sufficient clarity, to the understanding of an ordinary observer. Ex. 1003 ¶ 60 (referring to “me,” not the ordinary observer). When Mr. Peyser does turn to the relevant inquiry, therefore, focusing on the ordinary observer, his opinions are not tethered adequately to supporting facts. Ex. 1003 ¶ 61. Stated somewhat differently, his ultimate opinion is conclusory. See id.; see also In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (a petitioner’s burden of proving obviousness cannot be satisfied by employing “mere conclusory statements”).” slip op. at 15
- Expert testimonyPetitioner expert discountedOther
“Specifically, on that crucial issue, Mr. Peyser testifies “that the multiple perspective views are informative enough to prov[id]e me an understanding of what the front and rear views of the shaver head would look like.” Ex. 1003 ¶ 60 (emphasis added). Mr. Peyser neither explains why the perspective views are sufficient to disclose the missing front and rear views of the Philips OneBlade shaver head, nor keys his testimony, with sufficient clarity, to the understanding of an ordinary observer. Ex. 1003 ¶ 60 (referring to “me,” not the ordinary observer). When Mr. Peyser does turn to the relevant inquiry, therefore, focusing on the ordinary observer, his opinions are not tethered adequately to supporting facts. Ex. 1003 ¶ 61. Stated somewhat differently, his ultimate opinion is conclusory. See id.; see also In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016) (a petitioner’s burden of proving obviousness cannot be satisfied by employing “mere conclusory statements”).” slip op. at 15
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips - Gilead Sciences, Inc. v. The United States Of America, Represented By The Secretary Of The Department Of Health & Human ServicesInstitution deniedPTAB · Feb 20, 2020 · IPR2019-01453 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–11 and 13 unpatentable over Szekeres, Smith, or their combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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 that Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“Neither Szekeres nor Smith was cited during examination of the ’509 patent. Pet. 87–88. Instead, they “were considered during examination of a subsequently filed application.” Id. at 88; see also Prelim. Resp. 20 (Patent Owner conceding that “the Examiner considered Petitioner’s asserted references in the ’191 patent after the ’509 patent issued”). Under such circumstances, and because, as explained below, we deny institution based on substantive analysis of the Petition, we decline to decide whether institution should be denied on a discretionary basis under § 325(d).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“facts unique to each patent. See, e.g., Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370, 1373–76 (Fed. Cir. 2019) (affirming construction that result or efficacy language appearing in a wherein clause was limiting in light of the intrinsic evidence as a whole). Indeed, determining whether allegedly non-limiting language in a preamble or otherwise “involves examination of the entire patent record to determine what invention the patentee intended to define and protect.” Rowe v. Dror, 112 F.3d 473, 478–80 (Fed. Cir. 1997); Allergan, 935 F.3d at 1374 (holding the court “must read the claims in view of the entire specification” and prosecution history) (internal quotation marks and citations omitted). Based on the entire intrinsic record, we find “protection” is at the heart of the ’509 patent’s invention. In the body of claim 1, step (a) recites “selecting a primate host not infected with the immunodeficiency retrovirus.” Ex. 1001, 12:41–42 (emphases added). The “immunodeficiency retrovirus” in step (a), therefore, requires the preamble language for antecedent basis. Also, the preamble provides meaning about the nature of the infection recited in the body of the claim: “a self-replicating infection by an immunodeficiency retrovirus.”4 Id. at 12:38–39.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Moreover, the brief, high-level mention in Szekeres of Truvada’s FDA-approval does not sufficiently describe Truvada’s use in a PrEP treatment that satisfies step (b) of the claims. When anticipation is the issue, close is not enough. Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Indeed, “[a] prior art disclosure that ‘almost’” discloses all the elements arranged exactly as in the claim, “may render the claim invalid under § 103, [but] it does not 18 ‘anticipate.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983); see also Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (“[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.”). Here, Petitioner’s theory pieces together a host of disclosures, such as a potential for resistance with certain agents, and then filters and combines those disclosures based on what an ordinarily skilled person allegedly would have “understood” to ultimately conclude that Szekeres unambiguously describes PrEP combination therapy with Truvada.5 Pet. 38–42. But Szekeres simply does not describe in any adequate detail actual or prophetic use of Truvada in a PrEP regimen. In sum, Szekeres does not disclose step (b).” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,044,509
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.