- PTAB · Jan 29, 2025 · PGR2024-00043 · APJ John G New · PGR · Institution
The Board instituted PGR on all challenged claims, finding a sufficient likelihood that claims are anticipated or obvious under Grounds 1–10; it found Ground 11’s enablement challenge insufficient.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to 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.” For the reasons we explain below, we institute post-grant review of the ’943 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“asserted reference qualifies as prior art is public accessibility. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “[A]t the institution stage, the petition must 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, 13 (PTAB Dec. 20, 2019) (precedential).” slip op. at 15
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner
“priority benefit of the ’720 provisional application (at top center). See Ex. 1001, code (60) (listing “provisional application No. 5,995,873, filed on Oct. 2, 2006”). However, simply to claim the priority benefit of an earlier application is not necessarily to receive it. See In re NTP, Inc., 654 F.3d 1268, 1276 (Fed. Cir. 2011) (holding that “a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority.… Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120.”). As the diagram shows (and as we have verified), the ’529 application was a continuation-in-part of the preceding ’329 application. See Ex. 1001, code (63). However, the ’529 application was abandoned on February 10, 2016 (See Ex. 1052), and the succeeding application, U.S. Patent Application Ser. No. 15,474,875 (the “’875 application”) which is listed in the ’943 patent as being a continuation-in-part of the ’529 application, was not filed until March 30, 2017. See Ex. 1001, code (63) (stating that “said application No. 15/474,875 is a continuation-in-part of application No. 12/508,529”). Put simply, the ’875 application was not filed until over a year after the ’529 application was abandoned. As 35 U.S.C. § 120 states, in relevant part: An application for patent for an invention disclosed in the manner provided by section 112(a) (other than the requirement to disclose the best mode) in an application previously filed in the United States, or as provided by section 363 or 385, which names an inventor or joint inventor in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application. (emphasis added). In other words, if there is a “break in the chain” of priority caused by the abandonment or termination of an application claiming priority prior to filing of a subsequent application, the subsequent application loses the priority benefit of the abandoned or terminated application, as well as the priority benefit of all applications that antedate that abandoned or terminated application. Such is the case presently before us. Based on the current record, we are persuaded that the abandonment of the ’529 application prior to filing of the continuation-in-part ’875 application broke the priority chain leading to the ’720 provisional application, and the ’943 patent cannot, therefore, claim the priority benefit of the ’720 provisional application’s October 2, 2006 filing date. Consequently, the earliest date of which the ’943 patent could possibly claim the priority benefit is that of U.S. Patent Provisional Application Ser. No. 61/403,680 (the “’680 provisional application”) (located at the top of the left branch of the “family tree” depicted above), which has a filing date of September 20, 2010. See Ex. 1001, code (60). Burnett (i.e., the ’329 application) was filed on October 2, 2007 and thus antedates the ’680 provisional application. Consequently, Patent Owner’s argument fails based on the current record, and Burnett is prior art to the ’943 patent.” slip op. at 55
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Patent Owner’s request that we exercise our discretion under § 325(d) is not tenable. In deciding whether to exercise our discretion under § 325(d) in situations where only some of the challenges fall within its scope, we evaluate the challenges and determine whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting on all challenges. If so, the panel will evaluate whether the entire petition should be denied.” See USPTO, SAS Q&As (June 5, 2018) at D1, available at: https://www.uspto.gov/sites/default/files/ documents/ sas_qas_20180605.pdf; see also Kansas State Univ. Res. Found., PGR2022- 00021, Paper 11 at 7–8 & n.3 (Vidal Feb. 24, 2023) (holding that “the Board will further evaluate … whether § 325(d) is sufficiently implicated that its statutory purpose would be undermined by instituting review on all challenges presented in the Petition”). We having instituted post grant review based at least upon claim 1 of Ground 1 of the Petition. Even if the panel agreed with Patent Owner that Grounds 5–8 present “the same or substantially the same prior art or arguments” previously presented to the Office, § 325(d) would not be “sufficiently implicated” due to the 7 other asserted grounds. We therefore do not proceed with the § 325(d) analysis established in Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) and decline to exercise our discretion to deny the petition on that basis.” slip op. at 41
Claim construction§ 102 anticipation§ 112 disclosureDiscretionary denialcites Phillips · KSRPatents in suitUS 11,844,943 - 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 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 - Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Oct 17, 2024 · IPR2023-00875 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1 and 2 are unpatentable because the ’696 patent anticipates each claim.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“The parties’ proposed definitions of the level of ordinary skill, although different facially, are similar substantively. For example, both parties argue that a POSA would have high levels of skill, with advanced degrees and/or extensive work experience in organic chemistry.3 See Pet. 16; PO Resp. 21. In addition, Petitioner contends that a POSA would have had experience in the development of oligonucleotide building blocks. Pet. 16. Similarly, Patent Owner asserts that a POSA would have had education” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for patent owner
“have significant background in P(III) chemistry. Id. at 19; Sur-reply 12–13. According to Patent Owner, Dr. Baran published only about a dozen papers that relate to oligonucleotide synthesis, and the focus of those papers appears to be on P(V) chemistry, which is fundamentally different from P(III) chemistry. PO Resp. 19–20; Sur-reply 12–13. Although it does not challenge Dr. Baran’s qualification to provide opinion in this proceeding, Patent Owner asserts that “Dr. Baran’s lack of experience in P(III) synthesis[] should be strongly considered” in our evaluation of the weight of Dr. Baran’s testimony. Sur-reply 13. Patent Owner’s argument that Dr. Baran is principally experienced in P(V) chemistry presupposes that experience indicates an ignorance of P(III) chemistry. We do not find this position consistent with the breadth of Dr. Baran’s experience as indicated by his Curriculum Vitae. See Ex. 1003, 50–105. We weigh the testimonies of both Dr. Baran and Dr. Hrdlicka, against the cumulative weight of the evidence of record in assessing their credibility and probative value.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be disclosed in a single piece of prior art. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). For a claim directed to a genus, if a prior art reference discloses a species falling within the claimed genus, the species anticipates the genus. In re Slayter, 276 F.2d 408, 411 (CCPA 1960); see also Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298 (Fed. Cir. 2009) (stating that when a claim 2 US Patent No. 5,869,696, issued Feb. 9, 1999 (Ex. 1014, “the ’696 patent”). element is written in Markush form, “the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art”).” slip op. at 6
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“Resp.”) and a Motion to Amend Claims (Paper 11, “MTA”). In the MTA, Patent Owner proposed to replace claims 1 and 2 with substitute claims 4 and 5. MTA 1–2. Petitioner filed an Opposition to Patent Owner’s MTA (Paper 13) and a Reply to Patent Owner’s Response (Paper 14, “Reply”). After we entered Preliminary Guidance on Patent Owner’s Motion to Amend (Paper 15), Patent Owner requested authorization to withdraw its MTA (Ex. 3003). We granted that request. Paper 17. Thereafter, Patent Owner filed a Sur-reply to Petitioner’s Reply (Paper 20, “Sur-reply”).1” slip op. at 2
Patent outcomesUS 8,309,707 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 8,309,707 - Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Oct 17, 2024 · IPR2023-00862 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1 and 2 are unpatentable because Aerschot anticipates them.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“Patent Owner’s argument that Dr. Baran is principally experienced in P(V) chemistry presupposes that experience indicates an ignorance of P(III) chemistry. We do not find this position consistent with the breadth of Dr. Baran’s experience as indicated by his Curriculum Vitae. See Ex. 1003, 47–102. We weigh the testimonies of both Dr. Baran and Dr. Hrdlicka, against the cumulative weight of the evidence of record in assessing their credibility and probative value.” slip op. at 8
- Skill levelSkill level board ownOther
“The parties’ proposed definitions of the level of ordinary skill, although different facially, are similar substantively. For example, both parties argue that a POSA would have high levels of skill, with advanced degrees and/or extensive work experience in organic chemistry.3 See Pet. 12; PO Resp. 20–21. In addition, Petitioner contends that a POSA would have had experience in the development of oligonucleotide building blocks. Pet. 16. Similarly, Patent Owner asserts that a POSA would have had education and/or experience in “the development and syntheses of nucleosides, nucleotides, and nucleic acids.” PO Resp. 20–21. After considering the parties’ arguments and the prior art, we determine that a POSA would have had a Ph.D. (or equivalent degree) in organic chemistry or medicinal chemistry, with at least two to three years of post-graduate work experience in the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis. In addition, an individual with a Bachelor’s or Master’s degree and at least five years of work experience in these fields also would qualify as a POSA.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be disclosed in a single piece of prior art. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). For a claim directed to a genus, if a prior art reference discloses a species falling within the claimed genus, the species anticipates the genus. In re Slayter, 276 F.2d 408, 411 (CCPA 1960); see also Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298 (Fed. Cir. 2009) (stating that when a claim element is written in Markush form, “the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art”).” slip op. at 5
Patent outcomesUS 8,541,569 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 8,541,569 - Dexcom, Inc. v. Abbott Diabetes Care Inc.Institution deniedPTAB · Aug 8, 2024 · IPR2024-00520 · APJ John G New · IPR · Institution
The Board denied institution because Dexcom did not show a reasonable likelihood that claims 5–7 were unpatentable under either Stafford–Raymond ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Burden of Proof “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016 (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity … the evidence that supports the grounds for the challenge to each claim”)). Therefore, in an inter partes review, the burden of proof is on the Petitioner to show that the challenged claims are unpatentable; that burden never shifts to the patentee. See 35 U.S.C. § 316(e); In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (citing Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)). At the institution stage, Petitioner must show a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“We do not find these arguments persuasive. It may be so that Turner teaches that its recesses 77 receive rotation-restricting protrusions 71, which “extend[] into each recess 77 such that the recess side walls interfere with the protrusions to prevent rotation of the insertion device relative to body 20.” Ex. 1011 ¶ 69. And, it may also be so that Turner teaches this assembly as an advantage in that it prevents rotation of body 20. Id. However, Petitioner did not present this “design choice” theory of obviousness in the Petition. Petitioner first raises its “obvious design choice” argument with respect to Turner and Ground 2 in its Reply Brief; it is not to be found in its Petition.12 Petitioner cannot raise an argument in its” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In each of the ’335 Specification, Stafford, Raymond, and Turner, the OBU is universally depicted as having a circular perimeter oriented around a longitudinal axis, and possessing either a cylindrical shape (’335 patent, Stafford, Raymond) or a roughly domed shape, with a circular, circumferential collar. See, e.g., Ex. 1001, Figs. 8, 17, 52, 54; Ex. 1009, Figs 3A–C, 4A; Ex. 1010, Figs. 14–16, Ex. 1011, Figs. 2A–B, 5G, 7A-B, 9, 11, 13A–B, 14, 15, 19, 20, 21, 25, 29, 30, 37, 38. Moreover, in each description of the location of recesses 3766 in the ’335 Specification, the recesses are described as being located “on the side walls” of the OBU. See Ex. 1001, col. 44, ll. 8–12; col. 45, ll. 61–64. Given the circular perimeter of all of these embodiments of the disclosures of the ’335 Specification, the teachings of Petitioner’s cited references, the dictionary definition of “periphery” as being “the perimeter of a circle or other closed curve,” and the ordinary meaning that the terms would have had to a skilled artisan at the time of the invention, in view of the ’335 Specification and file history” (Phillips, 415 F.3d at 1312–13), we conclude that a person of ordinary skill in the art would understand that the “plurality of recesses disposed on a periphery of the on body electronics unit housing” would be located “on the circumference of the on-body housing,” as we concluded in the ’01396 IPR Decision. See Dec. 48; see also Ex. 1001, col. 44, ll. 9–14 (stating that “gripping arms 3762 [of medical device carrier 3730] are provided with engagement boss 3764 which are configured to engage with corresponding recesses 3766 provided on the side walls of the on body housing 322”).” slip op. at 38
- Strike new argumentNew argument disregardedDecided for patent owner
“However, Petitioner did not present this “design choice” theory of obviousness in the Petition. Petitioner first raises its “obvious design choice” argument with respect to Turner and Ground 2 in its Reply Brief; it is not to be found in its Petition.12 Petitioner cannot raise an argument in its 12 The Petition makes a design choice argument with respect to the teachings of Raymond on Ground 1, contending that “it would have been an obvious design choice to implement two spaced-apart plural recesses on the housing—one to engage the protrusions on each of the two arms taught by Raymond.” Pet. 38. However, Petitioner adduced no prior art teaching or evidence of record of “spaced-apart plural recesses on the housing” that Reply Brief if that argument could first have been raised in its Petition. 37 C.F.R. § 42.23(b); see also L’Oréal USA, Inc. v. Univ. of Massachusetts, 2018 WL 4278992, *5 n.4 (PTAB Sept. 7, 2018); Matterport, Inc. v. Appliance Comp. III, Inc., 2021 WL 6340164, *9–10 (PTAB Nov. 19, 2021).” slip op. at 32
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,266,335 - Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Jul 18, 2024 · IPR2023-00490 · APJ John G New · IPR · Final written decision
Claims 1–5 are unpatentable: claim 1 is anticipated by Reddy; claims 2–4 are obvious over the stated combinations; claim 5 is anticipated by Gaur.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“However, we prefer Patent Owner’s definition of the required 2–3 years of experience in “the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis (‘SPOS’)” to Petitioner’s more generalized requirement of having experience in “medicinal chemistry, synthetic organic chemistry, and nucleic acid chemistry, including the development of oligonucleotide therapeutics, diagnostics, or building blocks.” Both parties acknowledge that the level of skill in the art is very high. See, e.g., Resp. 17; Reply 2. We find that, to achieve a level of ordinary skill in the art, a person with the requisite educational background would require 2–3 years of experience for one possessing a doctorate in the relevant field, or 3–5 years for one with a lesser degree (to compensate for the additional educational experience gained by achieving a doctorate) in the specific techniques recited by Patent Owner. We reject the terminal clause “pursuant to P(III) chemistry” proposed by Patent Owner as redundant in that a person engaged for a number of years in “the development and syntheses of nucleosides, nucleotides, and nucleic acids” including SPOS, would likely have an operant knowledge of P(III) chemistry. Consequently we adopt the following definition of a person of ordinary skill in the art: “A person of ordinary skill in the art having a Ph.D. (or equivalent degree) in organic or medicinal chemistry, and 2 to 3 years of post-graduate work experience in the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis (‘SPOS’)” and, alternatively, “a person of ordinary skill in the art would have a Bachelor’s or Master’s degree in organic or medicinal chemistry who had at least 5 years of extensive work experience in these fields.”” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“As for Dr. Baran, we are not persuaded by Patent Owner’s argument that Dr. Baran is not sufficiently experienced or qualified to opine with respect to the claimed subject matter. A review of Dr. Baran’s extensive curriculum vitae (Ex. 1003, 79–137), indicates that he is deeply experienced and extensively published in the field of oligonucleotide synthesis. Patent Owner’s argument that Dr. Baran is principally experienced in P(V) techniques presupposes that experience in that technique indicates an ignorance of P(III) methodologies. We do not find this position consistent with the breadth of Dr. Baran’s C.V. We will weigh Dr. Baran’s testimony, and that of Dr. Hrdlicka, against the cumulative weight of the evidence of record in this inter partes review in assessing the credibility and probative value of their respective testimonies.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“Both parties agree that the terms of the challenged claims should be given the ordinary and customary meaning of such terms as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. Pet. 17; PO Resp. 15 (both citing 37 C.F.R. § 42.100). Accordingly we see no need for explicitly construing any of the terms of the challenged claims beyond that standard.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Furthermore, both Petitioner and Patent Owner agree that clear errors exist in the wording of challenged claims 3–5. Both parties agree that a person of ordinary skill in the art would have recognized that the limitation reciting “where M is selected from the group consisting of succinyl, oxalyl, and hydroquinolynyl” should properly read “where M is selected from the group consisting of ethyl, oxalyl, and hydroquinolynyl.” Pet. 18–20; PO Resp. 15. Both parties further agree that the language of claim 5 mistakenly omits the italicized portions of the limitation reciting “NH is capable of being attached to a solid support with a spacer selected from the group consisting of C1–C20 alkyl, ethyloxyglycol, and a combination of alkyl and ethyleneglycoxy,” as is expressly recited in claims 3 and 4. Pet. 21–22 (citing Ex. 1003 ¶ 158); PO Resp. 15. We agree with both parties’ reasoning with respect to these errors, and we construe the claims as reciting the corrected language, such that claims 3–5 read, in relevant part “where M is selected from the group consisting of ethyl, oxalyl, and hydroquinolynyl” and claim 5 additionally reads “NH is capable of being attached to a solid support with a spacer selected from the group consisting of C1–C20 alkyl, ethyloxyglycol, and a combination of alkyl and ethyleneglycoxy.” See Fitbit, Inc. v. Valencell, Inc., 964 F.3d 1112, 1119–20 (Fed. Cir. 2020) (holding that the Board erred in not correcting a “conspicuous” and undisputed error in claim).” slip op. at 8
Patent outcomesUS 9,884,885 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,884,885 - Cala Health, Inc. v. Emkinetics Inc.All claims unpatentablePTAB · Jul 1, 2024 · IPR2023-00511 · APJ Jason W Melvin · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–3 and 6 based on Govier anticipation and Govier-Williams obviousness; claims 4, 5, 7, and 8 based on obviousness over Govier-Mumford and Govier-Williams-Mumford.
RulingsFinal written decision- BurdenFwd all claims unpatentableUnpatentable
“We conclude that Petitioner has proven by a preponderance of the evidence that the challenged claims are unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends that a person of ordinary skill in the art “would have had an undergraduate degree in the field of biomedical engineering, or a related discipline, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could serve as a substitute for a formal degree and vice versa.” Pet. 10 (citing Ex. 1002 ¶ 23). Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, and we adopt it here.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“B. CLAIM CONSTRUCTION Petitioner argues that “no claim terms require express construction to resolve the challenges in this Petition.” Pet. 10. We agree and do not expressly construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe 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))).” slip op. at 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Govier describes a study in which patients with overactive bladders were given “percutaneous electrical stimulations via a 34 gauge needle placed near the tibial nerve 3 finger breadths above the ankle.” Ex. 1005, 1193. Specifically, “[a] 34 gauge, solid stainless steel needle was advanced through the skin” and “the needle was advanced approximately 3 to 4 cm. posterior to the tibia and, if advanced further, would traverse anterior to the fibula.” Id. at 1194. Govier further explains that “[a]n electrocardiogram ground pad was placed over the medial aspect of the calcaneus” and “[a] stimulator was then connected to the needle and the ipsilateral ground pad.” Id. This arrangement is depicted in Govier’s Figure 3, which is reproduced below.” slip op. at 6
Patent outcomesUS 9,387,338 unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,387,338 - Cala Health, Inc. v. Emkinetics Inc.All claims unpatentablePTAB · Jul 1, 2024 · IPR2023-00508 · APJ Jason W Melvin · IPR · Final written decision
Claims 1–8 are unpatentable as anticipated by Govier and obvious over Govier and Williams; the Board did not reach the additional grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends that a person of ordinary skill in the art “would have had an undergraduate degree in the field of biomedical engineering, or a related engineering discipline, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could serve as a substitute for an engineering degree.” Pet. 9–10 (citing Ex. 1002 ¶ 23). Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, and we adopt it here.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“B. CLAIM CONSTRUCTION Petitioner argues that “no claim terms require express construction to resolve the challenges in this Petition.” Pet. 10. We agree and do not expressly construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe 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))).” slip op. at 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We have reviewed Petitioner’s contentions and evidence and conclude that they prove anticipation of the challenged claims by Govier for the reasons given by Petitioner. Pet. 19–55.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable
“For claim 1, Petitioner asserts that, if Govier does not disclose applying an electrode patch to the outer surface of the skin, skilled artisans would have had reason to substitute Williams’s known electrode patch for Govier’s ground pad as a simple substitution of one known structure for another performing the same function—“creating a current path along the tibial nerve”—and yielding the same results—“ability to stimulate the tibial nerve to treat overactive bladder.” Id. at 21–24. Petitioner contends also that, if Govier does not disclose a controller including a pulse generator, skilled artisans would have had reason “to substitute Williams’s pulse generator for Govier’s stimulator.” Id. at 27–29. Petitioner reasons that skilled artisans would have found it obvious to try Williams’s pulse generator because of its similarities with Govier’s stimulator—“each create current pulses between 1–10 mA.” Id. at 28. Petitioner reasons further that using Williams’s pulse generator would have been a simple substitution. Id.” slip op. at 9
Patent outcomesUS 9,757,584 unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,757,584
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.