- PTAB · Jun 3, 2025 · IPR2025-00056 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1–30 and all three grounds, finding a reasonable likelihood that at least one claim would have been obvious over Perrett.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In determining whether to deny institution under § 325(d), we use 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. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted if the information presented by a petitioner in the petition, in view of the patent owner’s preliminary response and the preliminary record, shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314.” slip op. at 19
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A person of ordinary skill in the art (“POSA”) related to the ’061 patent would have a Ph.D., another advanced degree, or its equivalent, in areas related to pharmaceutics, chemistry, biology, medicine, or a related discipline, and 2-3 years of experience in formulation development. Alternatively, a POSA would have a lesser degree in those fields, with at least five or more years of experience in formulation development. The 8 See infra Section II.C. 9 At this stage of the proceeding, there is no evidence of objective indicia of obviousness or non-obviousness. POSA would also have had access to a medical doctor with a specialty in gastroenterology, and other individuals with expertise related to the above subjects. EX1070 ¶30. Pet. 5. At this stage of the proceeding, Patent Owner neither contests Petitioner’s proposed definition of the ordinarily skilled artisan nor provides an alternative definition. See generally Prelim. Resp. For the purposes of this Decision, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the high level of skill in the art reflected in the prior art of record and the ’061 patent, itself. 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)). D.” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownNo construction neededOther
“When the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.” Multiform Dessicants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). The Specification expressly states that “[t]he terms ‘orally disintegrating tablet’, ‘orally dispersing tablet’, or ‘ODT’ refer to a solid dosage form of the present invention, which disintegrates rapidly in the oral cavity of a patient after administration, without chewing.” Ex. 1001, 5:12–15. At this stage of the proceeding, we interpret the language “orally disintegrating tablet” / “orally dispersing tablet” / “ODT” to have the meaning as expressly set forth in the Specification, as noted above. slip op. at 23
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 11,260,061 - PTAB · Mar 18, 2025 · IPR2024-01375 · APJ Jason W Melvin · IPR · Institution
The Board instituted IPR of claims 1–13 based on both §103 grounds, finding a reasonable likelihood that the asserted combinations render at least one challenged claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“35 U.S.C. § 325(d) because Amarenco and Mann previously were presented to the Office during prosecution of the ’742 patent. See Prelim. Resp. 17–18. According to Patent Owner, Petitioner has identified additional references that “supposedly teach[] only some of what was missing—stimulation of a branch of the posterior tibial nerve but not to treat overactive bladder or incontinence.” Id. at 18. Patent Owner’s argument is flawed for two reasons. First, neither Svihra nor Ponsford were previously presented to the Office. Because Patent Owner does not argue that we should deny institution of Petitioner’s Svihra-based ground under § 325(d), and because that ground relies on a combination of art not previously presented, Patent Owner’s § 325(d) argument is unpersuasive. In that regard, we determine that even if we were to conclude the Amarenco-based ground warranted discretionary denial, the Svihra-based ground would not be subject to such denial and may alone justify institution. See USPTO, SAS Q&As (June 5, 2018) at D1.11 Additionally, for the Amarenco-based ground, Petitioner relies on a combination including prior art that was not previously presented, and Patent Owner does not show that additional prior art is cumulative to art presented during prosecution. We determine that Petitioner’s Amarenco-based ground 11 Available at: https://www.uspto.gov/sites/default/files/documents/ sas_qas_20180605.pdf is not substantially the same as one previously presented to the Office. Thus, we decline to discretionarily deny institution under § 325(d).” slip op. at 8
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of filing “would have had an undergraduate degree in the field of biomedical engineering or a related discipline, such as electrical engineering, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could substitute for a formal degree and vice versa.” Pet. 21 (citing Ex. 1003 ¶¶ 20–21). Patent Owner does not dispute Petitioner’s proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, we adopt it, and use “skilled artisans” to refer to people with such skill at the time the invention was filed.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner argues that “no terms require construction for purposes of this Petition.” Pet. 22. Patent Owner does not contest Petitioner’s position. See generally Prelim. Resp. We agree and do not expressly construe any terms at this stage. 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 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“It has long been recognized that the touchstone as to whether an 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 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,224,742 - 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 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 - PTAB · Apr 15, 2024 · IPR2023-01409 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted IPR on claims 1–30 and all eight asserted obviousness grounds, finding a reasonable likelihood that Stafford and Cote render at least one challenged claim obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“that if “the record of the Office’s previous consideration of the art is not well developed or silent, then a petitioner may show the Office erred by overlooking something persuasive.” Advanced Bionics, IPR2019-01469, Paper 6 at 10. Although Petitioner did not specifically state that the Examiner erred in not rejecting the claims over the prior art asserted here, under the second part of the Advanced Bionics framework, based on our analysis of the current record as a whole, we find that Petitioner has “ma[d]e a showing of material error,” in fact, the Petition is premised on it. Advanced Bionics, IPR2019-01469, Paper 6 at 8–9. In particular, Petitioner shows that the Office erred by overlooking something persuasive, namely, the teachings of at least Stafford and Cote, as highlighted in Petitioner’s unpatentability grounds. See Pet. 5 (arguing that each of Cote and Brenneman “provides express teachings on inserters for on-body units that were not considered by the Examiner”), 20–84 (Ground 1). In the Reasons for Allowance, the Examiner stated that “[w]hile Brister (US 2006/0016700) teaches the bulk of the claimed limitations, it fails to teach a housing . . . and an inserter with a sharp” that extends through the housing as claimed. Ex. 1002, 977. Petitioner, however, sufficiently demonstrates for purposes of institution that Stafford and Cote disclose these limitations. See Pet. 33–84 (explaining why Stafford and Cote teach or suggest the limitations of the challenged claims); see also infra Section III.E (determining that, on the current record, Petitioner establishes a reasonable likelihood that the claims challenged in Ground 1 are unpatentable as obvious over Stafford and Cote). Based on the circumstances elucidated by the current record, we find that Petitioner adequately shows that the Examiner “misapprehend[ed] or overlook[ed] specific teachings” of at least Stafford and Cote that “impact patentability of the challenged claims.” Advanced Bionics, IPR2019-01469, Paper 6 at 8 n.9. That is, Petitioner shows that the Examiner materially erred by not applying at least Stafford and Cote in the manner Petitioner argues and as supported by Dr. Fletcher.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“After considering the arguments and cited evidence of record, we find that for purposes of institution, Petitioner has demonstrated a reasonable likelihood that Stafford and Cote would have rendered claim 1 obvious. We have reviewed the arguments and evidence of record for claims 2–6, 9–14, 16–24, 27, 29, and 30 in Ground 1, and similarly find that for purposes of institution, Petitioner has demonstrated a reasonable likelihood that Stafford and Cote would have rendered these claims obvious. See Pet. 20–84; Ex. 1003 (Fletcher Decl.) ¶¶ 44–155. On this basis, we institute inter partes review of all challenged claims on all grounds in the Petition. See SAS Institute Inc., 138 S. Ct. at 1358; 37 C.F.R. § 42.108(a).” slip op. at 30
- Skill levelSkill level petitioner adoptedOther
“understanding of a person of ordinary skill in the art at the time the invention was made.11 See Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art would have had: a bachelor’s degree in bioengineering, mechanical engineering, electrical engineering, or a related subject, and one or more years of experience researching, developing, and/or designing insertable medical devices, including, e.g., systems for implanting wearable medical devices such as cannulas, infusion sets, and analyte sensors, or equivalent experience. Less work experience may be compensated by a higher level of education, such as a master’s degree, and vice versa. Pet. 10–11 (citing Ex. 1003 (Fletcher Decl.) ¶ 28). Patent Owner does not presently dispute Petitioner’s proposal or offer an alternative definition. See generally Prelim. Resp. 10 The record does not presently include any objective indicia of obviousness or nonobviousness. See generally Pet.; Prelim. Resp. 11 For purposes of this Decision, we apply a priority date of February 3, 2009. See supra 8 n.2. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party proposes that any claim term requires an express construction. See Pet. 19; see generally Prelim. Resp. We find it unnecessary to construe any claim term to decide whether Petitioner satisfies the “reasonable likelihood” standard for instituting trial. 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))). Any final written decision entered in this case may include express claim constructions, or may include discussion of claim scope that differs from that provided in our analysis below. Any final claim constructions will be based on the full trial record.” slip op. at 18
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,202,591 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution deniedPTAB · Feb 22, 2024 · IPR2023-01325 · APJ Timothy G Majors · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 2, and 4–6 were unpatentable under any asserted obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For reasons discussed below, we do not institute review of claims 1, 4, and 4–6 of the ’033 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“concerning the ’834 patent, the intrinsic evidence is minimally helpful in revealing an affirmative meaning for the claims’ “spacing(s)” terms. IPR2023-01151, Paper 12, 39–41. The Specification does not use the term “spacings” in relation to the positioning of adjacent fibers; the drawings might be helpful, but neither party proposes a specific construction that is reliant on them. And, portions of the prosecution record are arguably confounding. For example, the applicant distinguished claimed “spacings” from “tightly knitted fibers.” Ex. 2140, 1001 (suggesting a more “loosely defined fiber structure” may be covered); see also Ex. 1002, 29–30 (asserting the claimed design has “a lesser [fiber] density construction” compared to Walther). This begs the question, at what point does a cloth of “tightly knitted fibers” convert to a cloth having a “loosely defined” fiber structure that would come within the scope of the claimed “spacings?” The record does not answer. Applicant’s suggestion during prosecution that the claimed spacings between fibers are “intentionally placed” about the frame and not simply “the spacing that may be inherent” in fibrous cloths is also unavailing on this record in clearly defining the metes and bounds of the term. Ex. 1002, 28–29. Whether the alleged absence of “objective boundaries” for the term “spacings” supports a conclusion that the claims are invalid as indefinite would be a question for the court. Paper 11, 5 (arguing There is insufficient technical detail available to determine whether the SAPIEN 3 Ultra does or does not include “spacings” as claimed and we take no position on whether such device infringes any claim of the ’033 patent. that a conclusion that the claims are indefinite is “outside the Board’s [IPR] jurisdiction”).12 Notwithstanding the lack of any express claim construction for the “spacings” term from either party, claim 1 of the ’033 patent requires something more than just “spacings.” Claim 1 requires “spacings extending through a thickness of the sealing assembly that allow fluid to pass therethrough when the prosthetic heart valve assembly is in an undeployed state.” Ex. 1001, 22:11–15 (emphasis added). In other words, the spacings must allow fluid to pass through the sealing assembly’s thickness when the valve is undeployed. For reasons discussed below, we are not persuaded on this record that Petitioner is reasonably likely to prevail in showing that this limitation is met—particularly the fluid-passing element—in the proposed combinations of Spenser or Levi with Spenser II.” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We, thus, find Dr. Brecker’s testimony more credible that “[i]t would, accordingly, be counterintuitive for a [POSA] to look to a device designed to occlude a blood vessel when designing a TAVR.” Id. ¶¶ 119–120 (testifying “[n]o [POSA] would look to this [occluder] design when considering a TAVR valve and . . . would further have concerns about the pro-thrombotic potential of the arrangement of fibers in Chuter”). Where a proposed combination would run counter to the primary reference’s stated purpose, the POSA would not generally be motivated to make that combination. Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1069–70 (Fed. Cir. 2018).” slip op. at 43
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightDecided for patent owner
“Grounds 1 and 2 is based on the combination of either Levi and Spenser II, or Spenser and Spenser II. Yet Petitioner purports to modify Spenser II’s compressible material, or supplant it with something else, based on “porous” fabrics allegedly known elsewhere in the art, which art is not identified in the Petition itself as part of any asserted combination. Pet. 49. To see what specific modifications or combinations Petitioner might be suggesting, requires we look to three paragraphs of Dr. Buller’s Declaration, cited but not discussed by Petitioner, where eight additional references are mentioned. Ex. 1003 ¶¶ 157–159 (identifying Exs. 1106–1112, and 1129). This format is an improper incorporation-by-reference of argument and evidence that, had Petitioner wanted to pursue some other combination of asserted art beyond Levi, Spenser, and Spenser II, needed to be set forth explicitly in the Petition. 37 C.F.R. § 42.6(a)(3). Moreover, it leaves the record unclear and forces Patent Owner, the Board, and the public to guess at what combination(s) are, in fact, being urged. We also find that Petitioner’s position reveals a hindsight bias insofar as it suggests, with the aim of arriving at the claimed subject matter, removing Spenser II’s “sufficiently dense” and fluid impermeable compressible material (Ex. 2128 ¶ 222) in favor of some other sufficiently “porous” and fluid permeable material. Hindsight is further evidenced because Spenser II’s cited material is already described as being compressible and adapted to allow coagulation and tissue ingrowth—factors cited by Patent Owner as allegedly motivating a change to some other material. Ex. 1011 ¶ 145. Altogether, we find unpersuasive Petitioner’s position based on unspecified combinations of unasserted prior art to achieve benefits that Spenser II’s existing compressible material already provides.” slip op. at 36
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,491,033 - Edwards Lifesciences Corporation / Edwards Lifesciences LLC v. Aortic Innovations LLCInstitution deniedPTAB · Jan 9, 2024 · IPR2023-01151 · APJ Timothy G Majors · IPR · Institution
The Board denied institution on all asserted grounds because Petitioner did not show a reasonable likelihood that any challenged, undisclaimed claim was unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For reasons discussed below, we do not institute review of claims 2, 9, 17, and 18 of the ’834 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that the person of ordinary skill in the art (“POSA”) in November 2012 “would have been an interventional cardiologist with a working knowledge of heart valve designs and endovascular prostheses. This [POSA] would, where necessary, work with a medical device engineer to experiment with or manufacture a prosthetic heart valve.” Pet. 21 (citing Ex. 1003 ¶ 49). Patent Owner does not expressly contest Petitioner’s proposed definition. For this Decision, we apply Petitioner’s proposed POSA level, which appears to be consistent with the level of skill shown in the prior art of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). This POSA level is also consistent with the level the Board applied in earlier decisions involving the same parties and related patents. See, e.g., Ex. 2124, 11; Ex. 1120, 11–12.” slip op. at 16
- Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed
“during prosecution. Pet. 18, 99. According to Petitioner, Spenser II never describes its compressible material as including “tightly knitted fibers” and a POSA would, instead, have understood Spenser II’s compressible material as comprising “loose, porous materials.” Pet. 18, 99. We agree with Petitioner that the phrases “tightly knitted” and “tightly knitted fibers” do not appear in Spenser II. At the same time, neither does Spenser II describe its compressible material as being “loose” and “porous.” Notably, in prior proceedings before the Board, Petitioner’s declarant Dr. Buller testified that Spenser II’s compressible material “includes a plurality of PET fibers on the inward-facing surface of the compressible material” (i.e., the “base layer” and alleged “second plurality” of fibers here; Paper 9, 5), that is “sufficiently dense to prevent blood from leaking through the cloth/fabric.” Ex. 2128 ¶ 222; see also Ex. 2122, 20:2–22:18 (testifying that “nonporous” as used in the Specification means “that fluid would not pass through it” and such fluid includes “all components of blood”). We find that Dr. Buller’s description of Spenser II as having a dense, blood impermeable base layer is, on balance, more consistent with applicant’s characterization of Spenser II as having an arrangement of “tightly-knitted fibers”—even if some imagined or microscopic spaces between fibers might still exist in a base layer. Ex. 2128 ¶ 222; see also Ex. 2002 (Brecker testimony) ¶¶ 42–45 (testifying, inter alia, that the description of a “tight fitted outer seal is . . . consistent with Spenser II’s Figure 22” and “knitted” is consistent with Buller’s testimony describing Spenser II’s compressible material as “velour-like woven or knitted” PET (citing Ex. 1003 ¶ 162; Ex. 2134 ¶ 56). We are, thus, unpersuaded on this record that applicant mischaracterized Spenser II.” slip op. at 38
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Altogether, the parties’ alleged “plain meaning” yet otherwise undefined interpretation of the “spacing” limitations leaves the Board with insufficient clarity about what the claimed “spacing” means in the affirmative. Paper 9, 3 (arguing “plain meaning”); Paper 11, 3 (arguing applicant’s arguments are in “full harmony with the plain meaning”). The intrinsic evidence is minimally helpful: the Specification does not use the term “spacing” in relation to the positioning of adjacent fibers; the drawings might be helpful but neither party proposes a specific construction that is reliant on them.15 The prosecution history provides clues, but portions of the prosecution record are arguably confounding. The applicant distinguished 15 For example, Dr. Brecker, in support of Patent Owner’s argument, identifies several of the patent drawings and testifies that, “as is particularly clear in Figure 13 (but also present elsewhere), there are gaps and spaces between the fibers that extend to the frame” and then proceeds to testify that prior art, like Spenser II’s compressible material, “bears no resemblance” to the “exemplary” spacings identified in prosecution. See, e.g., Ex. 2002 ¶¶ 42–43. Dr. Brecker’s articulation of a “spacing” does not seem to add anything meaningful beyond the language of the claim as written. And, simply comparing the patent drawings to the prior art drawings presumes a sort of “know-it when you see it” interpretation—it is not an affirmative construction for a “spacing” as claimed. the claimed “spacings” from “tightly knitted fibers.” Ex. 1002, 1001. At what point, however, does a cloth of “tightly knitted fibers” qualify as more “loosely defined” and come within the scope of the claimed “spacing?”16 Id. The applicant also described the “spacing” in semi-functional terms based on “advantages” provided by the claim feature. See, e.g., id. (asserting, e.g., that the spacing permits “expansion and contraction” with “lesser rigidity”); see also id. at 1133, 1140 (asserting, e.g., “reduce[d] restrictions” and avoidance of “restrained valve foreshortening” with the then-claimed “openings”). It is not, however, evident where the Specification supports such “advantages”—no citations were given in prosecution. And, in prosecution of related applications, applicant argued, for example, that “[w]hile all fibers have some degree of being spaced-apart, the construction from Applicant’s claimed invention clearly requires some level more spacing.” Ex. 1149, 13–14 (assertion differences over “Dehdashtian” (alias to Spenser II)) (emphasis added). On this record, what would suffice as “some level more spacing” is unclear. Id.” slip op. at 39
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,337,834 - PTAB · Sep 15, 2023 · IPR2023-00726 · APJ Cynthia M Hardman · IPR · Institution
The Board instituted review of claims 1 and 3–5 on all asserted obviousness grounds based on Harder, Wolf, and European Pharmacopoeia, with Blass or Gartner as applicable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“petitioner’s challenge when determining whether to institute a post-grant proceeding in view of parallel district court litigation.” Memorandum 4. “Where the information presented at the institution stage is merely sufficient to meet the statutory institution threshold, the PTAB has the authority, where warranted, to exercise discretion to deny institution in view of the other Fintiv factors.” Id. “In contrast, where the PTAB determines that the information presented at the institution stage presents a compelling unpatentability challenge, that determination alone demonstrates that the PTAB should not discretionarily deny institution under Fintiv.” Id. at 4–5. As discussed below, we determine that Petitioner has shown a reasonable likelihood of demonstrating unpatentability of the challenged claims. Beyond that, given the facts relating to the other Fintiv factors in this case, we need not determine at this time whether Petitioner’s showing is “compelling” in order to decide whether to exercise our discretion to deny institution in this proceeding. Therefore, we treat this factor as neutral. 7. Conclusion In view of the Fintiv factors as presented in this case, and taking “a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review” (Fintiv, Paper 11 at 6), we are not persuaded that the interests of efficiency and integrity of the system would be best served by invoking 35 U.S.C. § 314(a) to deny institution of a determine the facts of this case do not warrant discretionary denial.” slip op. at 11
- Skill levelSkill level board ownOther
“For purposes of this Decision, we adopt part of the agreed portion of Petitioner’s proposal, namely, a person of ordinary skill in the art “would have a doctorate degree in Pharmaceutics or a related field with several years of experience in formulating compositions of and delivering medicines and nutritional supplements.” We find it unnecessary to specify a particular bachelor’s degree, because it does not appear to add any relevant subject matter beyond that possessed by someone having a doctorate degree in formulating compositions of and delivering medicines and nutritional supplements. Additionally, like Patent Owner, we find that the second sentence of Petitioner’s proposal is not supported. In particular, on this record Petitioner does not adequately explain for how many years and in what settings a person might obtain “related work experience in formulating compositions of and delivering medications and/or nutritional supplements to humans” that would be equivalent to that of a person having a doctorate degree in Pharmaceutics or a related field with several years of experience. In particular, although we agree with Patent Owner that “the ‘ordinary’ nurse may have knowledge and experience in delivering medicines and nutritional supplements” (Prelim. Resp. 18), Petitioner fails to explain how a nurse would obtain “related work experience in formulating compositions.” In sum, for purposes of this Decision, we determine that a person of ordinary skill in the art as of September 14, 2006, would have had a doctorate in Pharmaceutics or a related field with several years of experience in formulating compositions of and delivering medicines and nutritional supplements. During trial, to the extent the one or both parties disagree with this level of skill, we encourage the parties to indicate why they disagree, and to provide argument and evidence in support of any alternative proposal.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for petitioner
“1. “wherein said drop adheres to the surface of said object” We adopt the parties’ agreed construction of “wherein said drop adheres to the surface of said object,” i.e., we construe this term to mean: the drop is sufficiently viscous so that one drop does not immediately drip or roll away from the object that enters the mouth, so that no portion would drip off the object and surface. The drop does not coat or adhere to the object so as to prevent efficient removal of the drop from the object. Ex. 2005, 2. This construction is consistent with the teachings of the Specification, which indicate that determining whether a drop “adheres” to a surface is based on whether it is “sufficiently viscous so that one drop does not immediately drip or roll away from the object” yet does not “coat or sucking. Ex. 1001, 6:34–54; see also id. at Table 1, 6:34–7:27.” slip op. at 15
- Prior constructionPrior construction adoptedDecided for patent owner
“necessary for purposes of institution, to provide the parties notice, we address the district court’s construction of this term. The court held a hearing and heard argument from both sides, and ultimately construed the term “vitamin D” consistent with the express definition provided in the Specification. See Ex. 2010, 6–21; Ex. 1001, 3:53–56. For comity and because the district court’s construction is consistent with the Specification, we adopt it herein for purposes of this Decision. Specifically, we construe “vitamin D” to mean “(5Z-7E)-(3S)-9,10-seco- 5,7,10(19)-cholestatrien-3-ol also having the trivial names cholecalciferol or calciol (D3); and ergocalciferol (D2),” wherein “a person of ordinary skill in the art would understand this language to refer to either Vitamin D2 or Vitamin D3.”” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 9,066,958 - Eyenovia, Inc. v. Sydnexis, Inc.All claims unpatentablePTAB · Jul 13, 2023 · IPR2022-00384 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1, 2, 4–9, and 12–19 are unpatentable under § 103 over Chia, Akorn, and Kondritzer; the Board did not reach the other grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not agree with Patent Owner that the level of ordinary skill in the art should be limited to experience with ophthalmic formulation. The claims at issue generally require a liquid ophthalmic formulation of a small amount of atropine that is stabilized using buffers that can be stored for at least two weeks under certain temperature and humidity conditions. See Ex. 1001, 97:32–44 (claim 1). As Dr. Byrn points out, the technology surrounding use of atropine, a nonselective muscarinic antagonist, to treat myopia, has been extensively studied for over a hundred years and is known as “the oldest and most effective pharmacological treatment to inhibit the development of myopia.” See Ex. 1002 ¶ 26 (quoting Ex. 1008, 1) (citing Ex. 1003, 1; Ex. 1012, 2). The degradation of atropine is also well known to primarily result from cleavage of the acyl-oxygen bond during ester hydrolysis, see id. ¶ 43 (citing Ex. 1017, 1; Ex. 1024, 5), with the rate of acid-catalyzed reaction being much slower than that of the base-catalyzed reaction, leading to stability of atropine at a lower pH range (pH < ~3), see id. ¶ 45 (citing Ex. 1005, 1,4–5). Concerning specifically the use of atropine in the eye, Dr. Byrn points out that it is well known that ophthalmic solutions should be “formulated to be sterile, isotonic and buffered for stability and comfort.” See id. ¶ 47 (quoting Ex. 1019, 52) (noting Ex. 1019, 54 (pH of tear fluid is 7.4).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner states that “[f]or the purposes of this proceeding only, Petitioner does not believe that any claim terms need to be construed.” Pet. 22. Patent Owner “agrees that the claims should be understood according to their ordinary and customary meaning.” PO Resp. 25–26. In reply, Petitioner asserts that the ordinary meaning of “about” is” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find that Patent Owner’s criticism misses the mark. Petitioner is using the DailyMed exhibit as further evidence that Akorn was publicly available as of the revision date of 7/2014 as shown on Akorn, Ex. 1004. See Reply 1 (“As set forth in the Petition, EX1004, a drug label to Akorn, bears July 2014 revision dates that comport with its FDA approval and publication well before the critical date. See Pet., 9; Hulu, 13. It also bears Akorn’s corporate insignia. EX1004, 5. Additional evidence confirms these dates are reliable. EX1056-58.”); 3 (“Public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on July 24, 2014.”). Whether a POSA could have searched this way for labels published before the critical date is irrelevant; Petitioner is only using the evidence to show that Akorn was, in fact, published in July 2014, before the critical date on a searchable website. See id. Patent Owner does not dispute that DailyMed was searchable by drug name, which would be the logical way a POSA would search such a database for information for a drug of interest.” slip op. at 24
- ExcludeMotion to exclude, deniedDenied
“sufficiency of the support for Dr. Byrn’s opinions goes more to the weight to be accorded such opinions rather than a need to exclude such opinions. See TPG 40–41, 79 (“A motion to exclude must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used to challenge the sufficiency of the evidence to prove a particular fact.”). We also note that the findings in the district court litigation are based on a different record that is not before us here. For instance, the district court relies on a Lewis reference and a Harris reference that is not before us and testimony from Dr. Richard Moreton that is also not before us here. See Ex. 2010 ¶¶ 63–69. Therefore, we determine that the district court’s findings are not sufficiently probative of the questions before us here.” slip op. at 31
Patent outcomesUS 10,842,787 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,842,787 - Eyenovia, Inc. v. Sydnexis, Inc.All claims unpatentablePTAB · Jul 13, 2023 · IPR2022-00414 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–7 and 11–20 are unpatentable as obvious over Chia and Akorn; the Board did not reach the Wu and Akorn ground.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not agree with Patent Owner that the level of ordinary skill in the art should be limited to experience with ophthalmic formulation. The claims at issue generally require a kit with a vial of a pharmaceutical composition of atropine, water, and buffer, and instructions for use. See Ex. 1001, 99:12–19 (claim 1). As Dr. Byrn points out, the technology surrounding use of atropine, a nonselective muscarinic antagonist, to treat myopia, has been extensively studied for over a hundred years and is known 7 Although Patent Owner disagrees with Petitioner’s definition of a POSA, Patent Owner does not provide its own definition apart from including expertise in ophthalmic formulation. See PO Resp. 4–7. development of myopia.” See Ex. 1002 ¶ 26 (quoting Ex. 1008, 1) (citing Ex. 1003, 1; Ex. 1012, 2). The degradation of atropine is also well known to primarily result from cleavage of the acyl-oxygen bond during ester hydrolysis, see id. ¶ 43 (citing Ex. 1017, 1; Ex. 1024, 5), with the rate of acid-catalyzed reaction being much slower than that of the base-catalyzed reaction, leading to stability of atropine at a lower pH range (pH < ~3), see id. ¶ 45 (citing Ex. 1005, 1,4–5). Concerning specifically the use of atropine in the eye, Dr. Byrn points out that it is well known that ophthalmic solutions should be “formulated to be sterile, isotonic and buffered for stability and comfort.” See Ex. 1002 ¶ 47 (quoting Ex. 1019, 52) (noting Ex. 1019, 54 (pH of tear fluid is 7.4). None of this chemistry concerning the stability of atropine or its administration in the eye is remarkable or not well understood by a POSA as defined by Petitioner. See PO Resp. 10 (stating “the stability of atropine was understood to be a ‘predictable function,’ and a ‘routine matter,’ of temperature and solution pH”), 40–41 (same). We see no reason why someone with drug formulation experience, but not specific experience with ophthalmic solutions, would not qualify as a POSA. Therefore, we continue to apply Petitioner’s definition of a POSA in this final written decision.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “[f]or the purposes of this proceeding only, Petitioner does not believe that any claim terms need to be construed.” Pet. 21. Patent Owner “agrees that the claims should be understood according to their ordinary and customary meaning.” PO Resp. 25. In reply, Petitioner asserts that the ordinary meaning of “about” is “approximately,” and the ordinary meaning of “buffering agent” or “buffer” “is nothing more than an excipient that helps control pH.” Reply 2. Petitioner asserts that Patent Owner agrees with the definition of “buffering agent” and “buffer” by stating that “[t]he patent uses terms buffer and buffering in their normal sense, which entails providing pH control or maintenance.” Id. (quoting PO Resp. 28). Based upon our review of the evidence of record, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”). Insofar as the parties dispute whether Akorn discloses a buffer, we address those contentions in our discussion below of the challenged claims.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find that Patent Owner’s criticism misses the mark. Petitioner is using the DailyMed exhibit as further evidence that Akorn was publicly available as of the revision date of 7/2014 as shown on Akorn, Ex. 1004. See Opp. to Mot. to Exclude 8 (“Moreover, public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on that site at least by July 24, 2014. See EX1057, 3.”) As set forth in the Petition, EX1004, a drug label to Akorn, bears July 2014 revision dates that comport with its FDA approval and publication well before the critical date. See Pet., 10–22; Hulu, 13. It also bears Akorn’s corporate insignia. EX1004, 5. Additional evidence confirms these dates are reliable. EX1056-58.”); 3 (“Public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on July 24, 2014.”). Whether a POSA could have searched this way for labels published before the critical date is irrelevant; Petitioner is only using the evidence to show that Akorn was, in fact, published in July 2014, before the critical date on a searchable website. See id. Patent Owner does not dispute that DailyMed was searchable by drug name, which would be the logical way a POSA would search such a database for information for a drug of interest. Petitioner also provides further evidence that the Akorn label was published on July 24, 2014, through a response by the National Library of Medicine (“NLM”) to a Freedom of Information Act request. See Ex. 1071. confirmation that the substance of the Akorn label was posted on July 24, 2014, on the DailyMed website. Id. The National Institutes of Health (“NIH”) responded that version 7 of the Akorn label was published on DailyMed on July 24, 2014, and provided the URL that is reflected in the Akorn label in Exhibit 1057 from the DailyMed website. See Ex. 1072, 6; Ex. 1057, 4–7. NIH also confirmed that NLM “received version 7 of this label from the FDA on 07/24/2014 @ 2:15:04 PM,” “published version 7 on DailyMed on the same day, 07/24/2014 @ 14:59:48 PM,” and confirmed that “NLM does not make changes to the content contained within any SPL [or structured product labeling] records that it receives from the FDA.” Ex. 1072, 6. We find that Petitioner has provided more than sufficient evidence that the Akorn label reflected in Ex. 1004 was publicly available before the critical date. For the reasons set forth above, we determine that Petitioner has shown by a preponderance of the evidence that Akorn, Ex. 1004, is a printed publication that was publicly available before the critical date.” slip op. at 21
- ExcludeMotion to exclude, deniedDenied
“We agree with Petitioner here that Patent Owner’s concerns about the sufficiency of the support for Dr. Byrn’s opinions goes more to the weight to be accorded such opinions rather than a need to exclude such opinions. See TPG 40–41, 79 (“A motion to exclude must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used to challenge the sufficiency of the evidence to prove a particular fact.”). We also note that the findings in the district court litigation are based on a different record that is not before us here. For instance, the district court relies on a Lewis reference and a Harris reference that is not before us and testimony from Dr. Richard Moreton that is also not before us here. See Ex. 2010 ¶¶ 63–69. Therefore, we determine that the district court’s findings are not sufficiently probative of the questions before us here. Also, the district court’s findings are not as definitive as Patent Owner states. The patent owner in the district court case attempted to prove infringement by the doctrine of equivalents for a formulation that did not expressly contain a buffer, but that it argued inherently contained a buffer from the chemical disassociation of the active ingredient in the product. See Ex. 2010, 64–65. The district court found that patent owner failed to prove case is in stark contrast with the underlying facts of this proceeding in which the prior art formulation expressly contains the same buffers as claimed in the ’145 patent. See Ex. 1001, 99:33–35 (claim 5); Ex. 1004, 3. (c) Conclusion Based on the foregoing, we deny Patent Owner’s motion to exclude Exhibit 1002, Dr. Byrn’s testimony.” slip op. at 28
Patent outcomesUS 10,940,145 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,940,145
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.