- 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 29, 2025 · IPR2024-01174 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR on claims 1–8 and 10–23, finding a reasonable likelihood that claims 1, 3, 4, and 8 are unpatentable, including over Lesniak-based grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We determine that the first part of the Advanced Bionics framework is satisfied. Although the Examiner did not specifically apply Lesniak, Phinney, or Sturgis to the grounds of rejection for ’706 patent application, the Examiner considered these references as evidenced on the face of the ’706 patent indicating these were cited references, as well as by the Information Disclosure Statement that listed these three references. See Ex. 1001, code (56); Ex. 2001, 287, 297, 304. Various combinations of these references are asserted in six of the nine grounds before us in this proceeding. Therefore, we determine that same or substantially the same art previously was presented to the Office.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“summarized above, we determine that the information presented in the Petition establishes that Petitioner has shown sufficiently a reasonable likelihood of succeeding with respect to at least claims 1, 3, 4, and 8 challenged in Grounds I through IV.2 We are persuaded, based on the current record, that persons of ordinary skill in the art would have been motivated to make the different combinations of Lesniak, Phinney, Lamb, Bianchi ’518, Bianchi ’254 and Anconi for Grounds I through IV to arrive at the deodorant stick of at least claims 1, 3, 4, and 8 with a reasonable expectation of success. Below, we discuss how Petitioner has shown a reasonable likelihood of success that the teachings of Lesniak for claim 1 and the various combinations of Grounds II through IV would render obvious claims 3, 4, and 8, representative claims for these grounds.” slip op. at 30
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“rational motivation to combine, supported by Dr. Michniak-Kohn’s testimony, stating that Lesniak and Phinney are in the same field of endeavor as the ’706 patent—personal care compositions, including deodorant and/or antiperspirant sticks, that contain known antimicrobials and focus on the use of natural ingredients. Pet. 25 (citing Ex. 1001, Abstract, 1:26–44, 14:32– 60; 17:58–12, 18:65–26:36; Ex. 1003, Abstract, Title, 1:16–35, 3:39, 4:22, 4:61–67; 5:5–31, 8:43–46, 9:45, 10:27–33; Ex. 1004, Abstract, Title, 1:5–9, 5:52–60, 6:1–34, 8:40–44; Ex. 1002 ¶ 80). Petitioner points to Phinney’s teaching that that “’a mixture of the hydroxides of zinc and magnesium could provide long lasting protection against odour due to perspiration,’” versus using zinc oxide alone, which was less effective “due to insolubility and low hydrolysis rate to a hydroxide form that could show some activity.” Pet. 25–26 (citing Ex. 1004, 1:12–22, 2:33–37; 5:64–66, 5:48–49; Ex. 1002 ¶ 82); see Ex. 1002 ¶ 77.” slip op. at 32
- Expert testimonyPetitioner expert creditedOther
“Dr. Michniak-Kohn testifies that “a POSA would have been motivated to incorporate magnesium hydroxide into Lesniak’s composition following Phinney’s guidance, as this combination would improve odor protection while maintaining the ‘natural’ composition intended by Lesniak.” Ex. 1002 ¶ 77. Dr. Michniak-Kohn also testifies that “a POSA would have appreciated that deodorant compositions could be formed through various combinations of known ingredients, such as antimicrobials, as simple design choices.” Id. ¶ 79. We credit Dr. Michniak-Kohn’s testimony here as supported by the record before us at this stage of the proceeding. On the record before us, we determine that Petitioner has shown sufficiently a reason to combine the teachings of Lesniak and Phinney to arrive at claim 3.” slip op. at 33
§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 11,497,706 - PTAB · Jan 29, 2025 · IPR2024-01173 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR on claims 1–7 and 9–19 because Petitioner showed a reasonable likelihood that claims 1–3 and 14–17 are unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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 1–7 and 9–19 of the ’647 patent is unpatentable.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“this record, articulate a rational motivation to combine supported by Dr. Michniak-Kohn’s testimony, stating that both Lesniak and Bianchi are in the same field as the ’647 patent, which all relate to personal care compositions like deodorant and/or antiperspirant sticks and all discuss hardness as a relevant and measurable parameter for stick compositions. Pet. 33 (citing Ex. 1001, Abst., 15:6–44, 18:64–26:36; Ex. 1003, Abst., 3:39, 4:22, 8:43–46, 9:45, 9:60–62, 10:17–27, 15:41–42; Ex. 1006, Abst., 1:8–35, 2:56–58, 6:23–29); Ex. 1002 ¶ 81. As Petitioner points out, Lesniak discloses formulating deodorant sticks that have a desirable “skin feel,” prompting a POSA to review a publication like Bianchi ’518 to determine consumer-acceptable hardness ranges in formulating a stick composition. Pet. 31–32 (citing Ex. 1003, 1:16–35; Ex. 1002 ¶¶ 77–79). As Dr. Michniak-Kohn testifies, testimony which we credit based on the record before us, “by the time of the filing of the ’647 Patent, a POSA would have known that hardness was an ‘important physical parameter affecting consumer acceptance,’ and would have looked to achieve hardness levels that were taught in the field to achieve consumer acceptance,” such as Bianchi ’518. Ex. 1002 ¶ 77. Although Bianchi ’518 describes typical hardness levels of suspensoid antiperspirant sticks as they relate to “the invention,” there is nothing in Bianchi ’518 that would limit the application of preferred hardness levels only to the formulations of Bianchi ’518. See Ex. 1006, 6:23–29; see generally Ex. 1006. Contrary to Patent Owner’s assertions about a dearth of explanation by Petitioner as to how Lesniak would be modified to achieve the hardness disclosed in Bianchi ’518, Petitioner explains how the hardness of Lesniak’s deodorant stick could be adjusted to achieve the hardness Petitioner sufficiently explains on this record how this would be done: A POSA would have readily understood how to adjust the hardness of the stick, using Lesniak’s ingredients, inasmuch as a POSA would have known that adjusting the amount of structurant (using less if the deodorant was too hard, and vice-versa) could achieve the target hardness. For instance, Lesniak describes formulating a deodorant stick with 8% to 19% of a primary structurant, such as beeswax, and also optionally including 3% to 15% of a secondary structurant, such as sunflower seed wax and/or hydrogenated castor oil. A POSA would have understood that the hardness could be adjusted by altering the amount of the primary structurant and/or by incorporating secondary structurants.” slip op. at 30
- Expert testimonyPetitioner expert creditedOther
“sticks that have a desirable “skin feel,” prompting a POSA to review a publication like Bianchi ’518 to determine consumer-acceptable hardness ranges in formulating a stick composition. Pet. 31–32 (citing Ex. 1003, 1:16–35; Ex. 1002 ¶¶ 77–79). As Dr. Michniak-Kohn testifies, testimony which we credit based on the record before us, “by the time of the filing of the ’647 Patent, a POSA would have known that hardness was an ‘important physical parameter affecting consumer acceptance,’ and would have looked to achieve hardness levels that were taught in the field to achieve consumer acceptance,” such as Bianchi ’518. Ex. 1002 ¶ 77. Although Bianchi ’518 describes typical hardness levels of suspensoid antiperspirant sticks as they relate to “the invention,” there is nothing in Bianchi ’518 that would limit the application of preferred hardness levels only to the formulations of Bianchi ’518. See Ex. 1006, 6:23–29; see generally Ex. 1006. Contrary to Patent Owner’s assertions about a dearth of explanation by Petitioner as to how Lesniak would be modified to achieve the hardness disclosed in Bianchi ’518, Petitioner explains how the hardness of Lesniak’s deodorant stick could be adjusted to achieve the hardness Petitioner sufficiently explains on this record how this would be done: A POSA would have readily understood how to adjust the hardness of the stick, using Lesniak’s ingredients, inasmuch as a POSA would have known that adjusting the amount of structurant (using less if the deodorant was too hard, and vice-versa) could achieve the target hardness. For instance, Lesniak describes formulating a deodorant stick with 8% to 19% of a primary structurant, such as beeswax, and also optionally including 3% to 15% of a secondary structurant, such as sunflower seed wax and/or hydrogenated castor oil. A POSA would have understood that the hardness could be adjusted by altering the amount of the primary structurant and/or by incorporating secondary structurants.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 10,905,647 - PTAB · Jan 27, 2025 · IPR2024-01105 · APJ Sheridan K Snedden · IPR · Institution
Instituted review of claims 1–15 based on all six asserted grounds after finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We determine that the first part of the Advanced Bionics framework is satisfied. While the Examiner did not specifically apply Lesniak to the grounds of rejection for the ’542 application, the Examiner was aware of Lesniak during its prosecution as evidenced by the fact that Lesniak appears on an IDS signed by the Examiner, which is not disputed by Petitioner. Prelim. Resp. 11–15; Ex. 2001, 79; Pet. 21. We turn to whether Petitioner demonstrates that the Office erred in a manner material to the patentability of the challenged claims when it considered Lesniak. 2. Whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims Under the second part of the Advanced Bionics framework, we consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, Paper 6, 8. “An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id. at 8 n.9. We evaluate Becton, Dickinson factors (c), (e), and (f) to determine whether Petitioner has demonstrated material error. Id. at 10. Those factors are:” slip op. at 10
- 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 1–15 of the ’915 patent is unpatentable.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“35 U.S.C. § 103 as obvious over the combination of Lesniak and Phinney. Claims 2 and 10 depend from claim 1 and further require that the antimicrobial to be selected from, among other things, magnesium carbonate and magnesium hydroxide. Ex. 1001, 15:44–46, 16:1–14, 16:29–30. Petitioner concedes that Lesniak does not expressly teach the use of magnesium hydroxide. Pet. 34. However, Petitioner asserts that, in view of Phinney, a POSA would have found it obvious to add magnesium hydroxide to the composition of Lesniak. Id. Phinney states that metal oxides, such as zinc oxide, are not particularly efficacious antimicrobials in deodorants when used alone and describes using magnesium hydroxide as an antimicrobial in a deodorant stick in combination with zinc oxide. Id., 35. adequately articulate a reason why a POSA would combine Lesniak and Phinney. Prelim. Resp. 16–18. Having considered the parties’ positions and evidence of record, we determine that Petitioner has shown a reasonable likelihood that claims 2 and 10 of the ’915 patent are unpatentable as obvious over the combination of Lesniak and Phinney. At this stage in the proceedings, we disagree with Patent Owner that Petitioner has not articulated an adequate motivation to combine Lesniak and Phinney. Petitioner has articulated a clear motivation to combine these two references. Pet. 35. Specifically, Petitioner asserts that “[b]oth Lesniak and Phinney are directed to deodorants with ‘natural ingredients”’ and “[b]oth describe using known antimicrobials” and “[b]ecause Lesniak teaches using zinc oxide (a known antimicrobial) and Phinney teaches that using magnesium hydroxide in combination with zinc oxide improves antimicrobial properties, a POSA would have had a reason to follow Phinney’s teaching and add magnesium hydroxide to Lesniak’s composition.” Pet. 35.” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 27 (citing Ex. 1002 ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. Prelim. Resp. 7. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7
§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,966,915 - PTAB · Jan 23, 2025 · IPR2024-01104 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–18 based on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, Paper 6, 8. “An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.” Id., 8 n.9. We evaluate Becton, Dickinson factors (c), (e), and (f) to determine whether Petitioner has demonstrated material error. Id., 10. Those factors are: (c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; . . . (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 the prior art or arguments. Becton, Dickinson, Paper 8 at 17–18.” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“summarized above, we are persuaded, based on the current record, that persons of ordinary skill in the art would have been motivated to combine Lesniak, Phinney, and Bianchi ’518 to arrive at the deodorant stick of at least claim 1 with a reasonable expectation of success for the reasons stated in the Petition. Pet. 24–37. In particular, we are persuaded by Petitioner that Lesniak teaches natural anhydrous personal care compositions, including a deodorant stick in the form of an antiperspirant stick. Pet. 24 (citing Ex. 1003, 1:16–35, 4:22, 5:5–32, 10: 27, 10:32–33). Lesniak explains that such compositions include at least one antimicrobial (i.e., zinc oxide) and a where the compositions are free of an aluminum salt. Id., 24–25. While Petitioner concedes that Lesniak does not expressly teach that its compositions include magnesium hydroxide, for that element, Petitioner combines Phinney disclosure for using magnesium hydroxide as an antimicrobial in a deodorant stick. Id., 25–26 (citing Ex. 1004, 2:33–37). And Petitioner provides a reason to combine Lesniak and Phinney, noting that “[b]oth Lesniak and Phinney are directed to deodorants with ‘natural ingredients’ and both describe the use of known antimicrobials”. Id., 26–27 (citing to Ex. 1003, 4:61–5:31, 9:45, 10:27, 10:31–33, 3:39–4:21, 8:31–9:59; Ex. 1004, 1:5–9, 1:15–19, 5:52–67, 6:31–34, 8:40–44). Petitioner concludes that “a POSA would have been motivated to incorporate magnesium hydroxide into Lesniak’s composition following Phinney’s guidance, as this combination would improve odor protection while maintaining the ‘natural’ composition intended by Lesniak.” Pet. 27; Ex. 1002 ¶ 62 (same). Petitioner also concedes that Lesniak also does not expressly teach hardness as measured by penetration within an ASTM-D 1321 needle test, but that Bianchi ’518 discloses a hardness range by needle penetration. Id at 26–28. By combining these references of record in the manner proposed by the Petitioner, we are persuaded on the record before us that those of ordinary skill in the art would combine the teachings of Lesniak, Phinney, and Bianci ’518 to meet each limitation of claim 1 for the reasons set forth in the Petition. See e.g. id., 27 (“a POSA would have known that hardness was an ‘important physical parameter affecting consumer acceptance,’ and would have looked to achieve hardness levels that were taught in the field to achieve consumer acceptance”); see also Ex. 1002 ¶¶ 63–64 (same). Patent” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“summarized above, we are persuaded, based on the current record, that persons of ordinary skill in the art would have been motivated to combine Lesniak, Phinney, and Bianchi ’518 to arrive at the deodorant stick of at least claim 1 with a reasonable expectation of success for the reasons stated in the Petition. Pet. 24–37. In particular, we are persuaded by Petitioner that Lesniak teaches natural anhydrous personal care compositions, including a deodorant stick in the form of an antiperspirant stick. Pet. 24 (citing Ex. 1003, 1:16–35, 4:22, 5:5–32, 10: 27, 10:32–33). Lesniak explains that such compositions include at least one antimicrobial (i.e., zinc oxide) and a where the compositions are free of an aluminum salt. Id., 24–25. While Petitioner concedes that Lesniak does not expressly teach that its compositions include magnesium hydroxide, for that element, Petitioner combines Phinney disclosure for using magnesium hydroxide as an antimicrobial in a deodorant stick. Id., 25–26 (citing Ex. 1004, 2:33–37). And Petitioner provides a reason to combine Lesniak and Phinney, noting that “[b]oth Lesniak and Phinney are directed to deodorants with ‘natural ingredients’ and both describe the use of known antimicrobials”. Id., 26–27 (citing to Ex. 1003, 4:61–5:31, 9:45, 10:27, 10:31–33, 3:39–4:21, 8:31–9:59; Ex. 1004, 1:5–9, 1:15–19, 5:52–67, 6:31–34, 8:40–44). Petitioner concludes that “a POSA would have been motivated to incorporate magnesium hydroxide into Lesniak’s composition following Phinney’s guidance, as this combination would improve odor protection while maintaining the ‘natural’ composition intended by Lesniak.” Pet. 27; Ex. 1002 ¶ 62 (same). Petitioner also concedes that Lesniak also does not expressly teach hardness as measured by penetration within an ASTM-D 1321 needle test, but that Bianchi ’518 discloses a hardness range by needle penetration. Id at 26–28. By combining these references of record in the manner proposed by the Petitioner, we are persuaded on the record before us that those of ordinary skill in the art would combine the teachings of Lesniak, Phinney, and Bianci ’518 to meet each limitation of claim 1 for the reasons set forth in the Petition. See e.g. id., 27 (“a POSA would have known that hardness was an ‘important physical parameter affecting consumer acceptance,’ and would have looked to achieve hardness levels that were taught in the field to achieve consumer acceptance”); see also Ex. 1002 ¶¶ 63–64 (same). Patent” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention “would have (1) at least a B.S. or equivalent degree; and (2) at least two years of experience in cosmetics formulations.” Pet. 24 (citing Ex. 1002, ¶¶ 26–28). Patent Owner does not dispute Petitioner’s proposal about the POSA’s qualifications. Prelim. Resp. 8. For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,540,999 - Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc.All claims unpatentablePTAB · Nov 26, 2024 · PGR2021-00088 · APJ John G New · PGR · Final written decision
Claims 1–25 are unpatentable because the ’908 patent lacks written description support under § 112(a); the Board did not reach Grounds 1–3 or 5.
RulingsFinal written decision- ExcludeMotion to exclude, deniedMixed
“To the extent that Dr. Dobs has admitted that she is “not comfortable with chemical terminology”; “could not answer questions regarding the chemical structures in the prior art articles”; “did not know whether CRF1 receptor antagonists contained the structural features she deemed ‘essential’ in her Declaration”; and “agreed that tildacerfont has structurally unique features” (see Ex. 1038, 52–53, 125–126, 126–128, 128–130), we will weigh her testimony regarding those matters accordingly. However, for the reasons explained above, Petitioner’s Motion to Exclude Dr. Dobs’ written description opinions in paragraphs 19 and 80–91 of Exhibit 2014 is denied.” slip op. at 10
- Strike new argumentOther
“Analysis Patent Owner’s Exhibits 2020–2026 play no part in our reasoning and were not relied upon by the Board in reaching our Decision. Petitioner’s Motion to strike Exhibits 2020–2026 is therefore dismissed as moot.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Response. Because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004, 2005), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we adopt Petitioner’s definition.” slip op. at 26
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“For these reasons, we do not find persuasive the testimony of Patent Owner’s expert, Dr. Dobs, that: By describing adjustments of dosing protocols to achieve at least a 10% reduction from baseline, and describing this use of tildacerfont as just one embodiment of the claimed use of the entire well-known, well-characterized, and discrete class, the specification reasonably conveyed to a POSA that the invention extended to the particularly claimed use of the entire recited class. Ex. 2014 ¶ 87. On the contrary, far from being a “well-known, well-characterized, and discrete class” the prior art teaches a heterogeneous assembly of different classes of small molecule CRF1 receptor antagonists (Type I, Type II, and “atypical”) displaying a very considerable variety of structures, both in terms of the core pharmacophore (e.g., monocyclic, bicyclic, tricyclic, phenolic, cyclohexyl amide, etc.) as well as in the various side groups. Moreover, the challenged claims recite only “a CRF1 receptor antagonist or a pharmaceutically acceptable salt thereof,” the scope of which also encompasses the much larger (and, according to Williams) much more effective large-molecule (peptide) CRF1 receptor antagonists, about which the Specification is entirely silent. See Ex. 1029, Abstr., 1065.” slip op. at 56
Patent outcomesUS 10,849,908 unpatentable§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908 - Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Rehearing deniedPTAB · Oct 1, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Rehearing
The Board denied rehearing and maintained its denial of PGR because Petitioner did not show that Perkins and RCSB PDB made claims 1–30 more likely than not unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. LEGAL STANDARD Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists where a “decision [i]s based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). A rehearing request is not an opportunity for the requesting party to reargue its case or merely to express disagreement with the underlying decision. Nor is it an opportunity for the moving party to present new arguments that were not in its original submissions.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Owner’s argument persuasive because Perkins discloses embodiments with “mutations at I182 among a group of 20 other possible locations for modifications,” 13 of which are mutations of specific amino acids that “can be changed to any of the 19 other natural amino acids.” Id. Perkins discloses further that modifications at each of those 20 possible sites can be combined such that “one, two, or more” of the mutations can be made together in other embodiments (Ex. 1006, 17–18), or in other words, “each species [is] combinable to create a vast number of species.” Dec. 35. In addition to the locations of modifications expressly listed in Perkins, Perkins adds yet another option in which “the mutated VSV-G envelope protein is as described in Nikolic et al.” (Ex. 1006, 18), which “describes the crystal structures of VSV G bound to its native LDL-R receptor” that RCSB PDB depicts in entries 5OY9 and 5OYL (Dec. 18). We also considered Dr. Rose’s testimony about the crystal structures depicted in RCSB PDB, namely that a person of ordinary skill in the art would have been motivated to modify Perkins based on the VSV-G crystal structures in the RCSB PDB. Perkins taught that mutations to VSV-G “inhibit binding of VSV-G to the low-density lipoprotein receptor (‘LDL-R’), while preserving the VSV-G protein’s fusogenic function,” and expressly disclosed making a mutation at I182. (See, e.g., Ex. 1005 at 19:29-20:2, 20:29-21:14, 21:16-27; Ex. 1006 at 16.) The VSV-G crystal structures in the RCSB PDB taught that I182 is nearby negatively charged amino acids on the LDL-R. Thus, a person of ordinary skill in the art would have been motivated to incorporate a mutation which negated an interaction with the negatively charged residues in the LDL-R. (Ex. 1005 at 19:29–20:2; Ex. 1006 at 16.) Dec. 37. discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 7
§ 103 obviousnessPatents in suitUS 11,767,366 - PTAB · Sep 23, 2024 · IPR2024-00625 · APJ Deborah Katz · IPR · Institution
The Board instituted IPR of claims 1–8 on all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable and declining discretionary denial under §§ 314(a) and 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner
“invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundDecided for petitioner
“invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner argues that Pernot teaches treating colorectal cancer and that, therefore, because the MSI-H Study Record is directed to a clinical study treating colorectal cancer in a patient whose cancers are MSI-H with pembrolizumab, which is an anti-PD-1 antibody, one of ordinary skill in the art knowing the teachings of the MSI-H Study Record would have considered the teachings of Pernot. (See Pet. 36.) Petitioner argues that Pernot teaches that colorectal cancer patients that are MSI-H are “good candidates for immunotherapy,” such as PD-1 inhibitors. (See Pet. 36 (quoting Ex. 1006, 3741 (“[Colorectal cancer] associated with MSI could lead to a more intense immune response, but also to specific immunoregulatory phenomena, making [patients with colorectal cancer] good candidates for immunotherapy.”)).) Petitioner cites further to Dr. Neugut’s testimony to argue that one of ordinary skill in the art would have been motivated to combine the disclosure of Pernot with the methods taught in the MSI-H Study Record in order to obtain the results of the MSI-H Study Record’s study. (See Pet. 36 (citing Ex. 1003 ¶ 93).)” slip op. at 17
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 11,339,219 - PTAB · Sep 5, 2024 · IPR2023-01300 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–13 and all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a). A decision to institute is “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons set forth below, we determine that Petitioner has demonstrated that there is a reasonable likelihood that at least one of the challenged claims is unpatentable. Accordingly, we institute an inter partes review of the challenged claims in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have possessed a strong understanding in the use and development of genetics and genomics approaches for detecting or monitoring human diseases, such as spatial detection of a target analyte (e.g., mRNA or DNA) in a tissue, and would typically have a Ph.D. in a relevant field (e.g., molecular biology, genetics, and bioinformatics) with two years of experience. Pet. 21–22 (citing Ex. 1044 ¶¶ 24–36). For the purposes of its Preliminary Response, Patent Owner does not provide its own proposed level of skill. Prelim. Resp. 7. For purposes of this Decision, we apply Petitioner’s unchallenged definition as it is consistent with the cited prior art and disclosure of the ’142 patent.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Thus, according to claim 1, to synthesize a first/second plurality of DNA products by performing a synthesis reaction, the “DNA products” must 1) use the oligonucleotides collected in steps (a) and (b) as templates from which the DNA is synthesized, and 2) incorporate a source location-identifying nucleic acid sequence.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner
“(2) Analysis Neither party has offered a construction for “collecting oligonucleotides under conditions that release them” in claim 1. We note that, in the related litigation, the district court determined that “under conditions that release” should have its plain and ordinary meaning. Ex. 1052, 38. For purposes of institution, we also apply the plain and ordinary meaning of this claim phrase and do not need to expressly construe the claim phrase for purposes of institution. On this record, for the reasons explained by Petitioner and as supported by its declarant testimony, we conclude Petitioner has sufficiently shown that So-456 discloses the “collecting oligonucleotides under conditions that release them” limitation recited in claim 1.” slip op. at 42
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,473,142 - PTAB · Aug 22, 2024 · IPR2024-00580 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted review of claims 1, 3–6, and 8 on all asserted grounds, finding a reasonable likelihood that at least claim 1 would be shown obvious over the ’772 Publication and Snowdy.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Beginning with independent claim 1, we determine that Petitioner has met its burden for institution. Based on the current record, Petitioner has shown a reasonable likelihood of succeeding in establishing that the combination of the ’772 Publication and Snowdy renders at least claim 1 obvious.” slip op. at 18
- Skill levelSkill level petitioner adoptedOther
“Pet. 12 (citing Ex. 1005 ¶¶ 111–115). Patent Owner states that it does not dispute this definition for purposes of the Preliminary Response. Prelim. Resp. 16. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’462 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)); Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., 200 F.3d at 803)).” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundOther
“We agree with Patent Owner on the record before us that Petitioner does not appear to offer sufficient evidence and reasoning as to why a POSA would have modified AAVrh.10 at position 665 as described as opposed to other modifications based solely on the disclosure of the ’772 Publication. We do agree with Petitioner, however, that on the record before us, Snowdy provides such sufficient evidence and reasoning. See Pet. 47–52.” slip op. at 26
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,680,274
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.