- PTAB · Jun 6, 2025 · IPR2025-00257 · APJ Lilan Ren · IPR · Institution
The Board instituted IPR on claims 1–15 and all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Cable and Naware and over Comb and Tummala.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“discussed below, we decline to exercise our discretion to deny the Petition.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314 (2024); 37 C.F.R. § 42.4(a) (2024). Institution of an inter partes review requires that “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we determine that there is a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim, and we institute an inter partes review.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“persuaded that Petitioner has sufficiently shown for purposes of institution that a person of ordinary skill in the art would have been motivated to combine the teachings of Cable and Naware in the manner argued by Petitioner. For example, both references directly relate to 3D printing, and we are persuaded that Cable teaches “a heated build platform and calls on the POSITA to implement this teaching via suitable solutions known in the art.” Pet. 13 (noting that Cable teaches a build platform that can be heated “by any suitable heating elements” (citing 1006 ¶ 45)). The current record also indicates that Naware taught known options in this regard, e.g., where it describes a build plate to be used in a 3D printing process that includes contact plates and temperature control modules. See, e.g., Ex. 1007, code (57). Petitioner additionally argues that there is a reasonable expectation of success in combining Cable with Naware because “3D printers with temperature-controlled heated build plates were well-known technologies at the time of the ’660 patent in 2014, and these technologies had been successfully demonstrated in the real-world by then.” Pet 15 (citing various portions of Ex. 1003). Patent Owner does not contest Petitioner’s arguments with respect to a reasonable expectation of success in combining Cable with Naware. See generally Prelim. Resp. Based on our review and consideration of the current record, we are persuaded that Petitioner has sufficiently shown for the teachings of Cable and Naware in the manner argued by Petitioner.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner “does not contest Petitioner’s description of a person of ordinary skill in the art (a ‘POSITA’) having a bachelor’s degree in Mechanical Engineering, Chemical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” Prelim. Resp. 37. Patent Owner does not address the specific knowledge that Petitioner contends that ordinarily skilled artisan would possess. Id. For purposes of this decision, we adopt Petitioner’s unopposed definition of the level of ordinary skill in the art as it appears consistent with the disclosures of the ’660 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 18
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,592,660 - Wuhan Healthgen Biotechnology Corp. v. Ventria Bioscience Inc.Institution deniedPTAB · Aug 19, 2022 · IPR2022-00712 · APJ Michael A Valek · IPR · Institution
Institution was denied for claims 1–9 and 11–13 because the petition did not show a reasonable likelihood of establishing unpatentability on any asserted obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Regarding the alleged motivation to combine Tanaka’s purification “guidance,” Petitioner has not articulated persuasive reasoning with rational underpinning to explain why a POSA would have sought to further purify Deeter’s rHSA. Deeter already teaches that its rHSA is purified using ion-exchange chromatography and reports that such rHSA is equivalent to or better than pHSA in stimulating cell growth. Ex. 1003 ¶¶ 116–120 (Examples 7–9). In view of these disclosures, Petitioner has not sufficiently explained why a POSA would be have been motivated to apply a different purification process or to add additional purification steps to Deeter’s existing process.” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“We find that Petitioner’s description of the level of ordinary skill in the art is supported by the record. Thus, for purposes of this decision, we apply Petitioner’s description of a POSA.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Neither party suggests that the issues presented in the Petition turn on claim construction. See Pet. 16 (noting the parties’ competing constructions in a related proceeding, but urging that the prior art discloses the limitations “[r]egardless of which interpretations are applied”); Prelim. Resp. 19 (“validity of the ’951 patent does not hinge on claim construction”). We agree that no formal claim construction is necessary for this decision. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Regarding the alleged motivation to combine Tanaka’s purification “guidance,” Petitioner has not articulated persuasive reasoning with rational underpinning to explain why a POSA would have sought to further purify Deeter’s rHSA. Deeter already teaches that its rHSA is purified using ion-exchange chromatography and reports that such rHSA is equivalent to or better than pHSA in stimulating cell growth. Ex. 1003 ¶¶ 116–120 (Examples 7–9). In view of these disclosures, Petitioner has not sufficiently explained why a POSA would be have been motivated to apply a different purification process or to add additional purification steps to Deeter’s existing process.” slip op. at 13
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,618,951 - Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentablePTAB · Nov 18, 2020 · PGR2019-00048 · APJ David Cotta · PGR · Final written decision
Claims 1–13 were not shown unpatentable because the prior art did not establish a reasonable expectation that doses above 300 mg/day of mifepristone could be safely co-administered with a strong CYP3A inhibitor.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“The definition of a POSA that best incorporates both experience with drug-drug interaction and experience treating patients is Petitioner’s proposed multidisciplinary team. Patent Owner does not object to defining the POSA as part of a multidisciplinary team, so long as that team includes a person with experience treating Cushing’s syndrome, which, as discussed above, is appropriate. Tr. 38. Accordingly, we define the POSA as: a multidisciplinary team that includes researchers and clinicians in the field and is able to draw upon not only the individual skills of each team member, but also the specialized skills of others to solve a given problem. The 6 Claim 5 and its dependents are directed to “[a] method of treating symptoms associated with elevated cortisol levels.” Cushing’s syndrome is “caused by excess levels of cortisol.” Ex. 1001, 1:31–33. Accordingly, claim 5 relates to Cushing’s syndrome even if it does not specifically recite that the patient has Cushing’s syndrome. All of the other claims expressly recite Cushing’s syndrome. researchers and clinicians would have an M.D., a Pharm. D., and/or a Ph.D. in pharmacology or a related discipline. The clinician would have at least four years of experience treating patients with Cushing’s syndrome using mifepristone and/or CYP3A inhibitors. The researcher would have at least four years of experience studying drug-drug interactions involving CYP3A inhibitors.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Further, if we were to consider Petitioner’s new argument, we would find that the claims do require safety, as entirely consistent with what both parties unmistakably understood, as evidenced by their patentability arguments throughout the proceeding (until Petitioner’s new argument in its Reply). In this regard, we note that the preambles in the independent claims at issue, i.e., in claims 1, 5, and 10, are necessarily limiting and we consider the scope of the challenged claims as a whole, including preambles, in our patentability analysis. The preamble in claim 1, for example, recites a “method of treating Cushing’s syndrome in a patient who is taking an original once-daily dose of 1200 mg or 900 mg per day of mifepristone.” Ex. 1001, 68:2–16. Claims 5 and 10 contain similar language relating to a patient taking an “original once-daily dose” of 1200 mg or 900 mg per day of mifepristone, although claim 5 is directed to a “method of treating symptoms associated with elevated cortisol levels,” and claim 10 is directed” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In addition, when considering the recited methods of treatment (or controlling hyperglycemia) in a patient in the context of the specification, we interpret the recited methods to require administration of drugs in a manner that is safe for a patient. The summary section in the specification of the ’214 patent, for example, states that: concomitant administration of a CYP3A inhibitor such as ketoconazole and a GRM such as mifepristone is believed to be safe for the subject, and to provide the therapeutic benefits of both drugs to the subject, and may allow the reduction in the amount of a GRM, or of a CYP3A inhibitor, administered to the subject; such reduction may reduce the risk of toxic effects of the CYP3A inhibitor concomitantly administered with the GRM. Ex. 1001, 3:50–58 (emphasis added); see id. at 4:4–21. That disclosure, along with many other statements in the specification, clarify that safety and efficiency are important aspects of the recited methods, especially in relation to toxic effects that might preclude treatment in patients. See also id. at 13:1–3 (stating “Applicant discloses herein methods for the safe concomitant administration of both a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitor to a subject.”), 13:10–23 (same).” slip op. at 20
- Strike new argumentNew argument disregardedDecided for patent owner
“Our regulations require the Petition to identify “[h]ow the challenged claim is to be construed” and “[h]ow the construed claim is unpatentable.” 37 C.F.R. § 42.104(b)(3),(4). A reply is not an opportunity to start anew, to fill in gaps or to remedy omissions in a petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018) (explaining that “petitioner’s contentions [in a petition] ... define the scope of the litigation all the way from institution through to conclusion.”); see also Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019), https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf. We therefore decline to consider Petitioner’s belatedly presented new argument in its Reply that the claims do not require safety. See Acceleration Bay, LLC v. Activision Blizzard Inc., 908 F.3d 765, 775 (Fed. Cir. 2018) (concluding that the Board did not abuse its discretion in refusing to consider portions of a reply declaration “rais[ing] a new obviousness argument for [a claim] limitation that could have been made in the petition” but was not); Intelligent Bio-Sys., 821 F.3d at 1369–70 (concluding that the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)). Even if we were to consider Petitioner’s new argument regarding claim construction, we would not find it persuasive because Petitioner’s obviousness rationale incorporates an expectation of safety. Irrespective of whether the claims require safety, Petitioner cannot carry its burden to establish that the claimed methods would have been obviousness without establishing that – as posited in the Petition – the POSA would have expected co-administration to be safe.” slip op. at 18
Patent outcomesUS 10,195,214 not shown unpatentableClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,195,214 - Reactive Surfaces Ltd., LLP v. LG Chem Ltd.All claims unpatentablePTAB · Feb 24, 2020 · IPR2018-01520 · APJ Timothy G Majors · IPR · Final written decision
Claims 1–8 are unpatentable as obvious; the contingent motion to amend is granted for substitute claims 9–16.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. “anti-fingerprint coating” The phrase “anti-fingerprint coating” appears twice in claim 1: first in” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“fingerprint must “vaporize” from the coated surface.30 As discussed above (Section III(C)), the claimed “anti-fingerprint” functionality encompasses a coating that is capable of actively reducing transfer of a fingerprint or decomposing a fingerprint transferred to a surface of the coated substrate. Accordingly, notwithstanding Buchanan’s shortcomings in evidencing inherent vaporization of enzymatically decomposed fingerprint components, we are unpersuaded this is fatal to Petitioner’s challenge. Rather, for” slip op. at 43
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“conclusory” lack merit. Dr. Cairns has relevant expertise in this area, whereas Petitioner’s declarant, Dr. Rozzell, does not. Ex. 2035 (Rozzell dep.), 128:15–20 (“[Y]ou are not a person of ordinary skill in the art as it pertains to the use of haze values to assess visibility, are you? A. No.”); Ex. 2033 (Cairns Decl.) ¶¶ 2–9 (describing, inter alia, Dr. Cairns’s many years of experience working with and researching specialized coatings for display and touch-sensor applications and optical properties for such devices). Accordingly, Dr. Cairns’s testimony about there being a recognized and sufficiently definite correlation between haze and contaminant (including fingerprint) visibility on display devices is entitled to greater weight than Dr. Rozzell’s opinions on the topic. See, e.g., Ex. 2036 ¶¶ 62–67 (analyzing portions of the patent and prior art to support the opinion that haze is correlated to visibility); Ex. 2035 (Rozzell dep.) 125:1– 16 (“[W]hatever familiarity you have acquired with respect to the utilization of haze as a measurement of visibility has been acquired in the context of this IPR; correct? A That’s correct.”). Dr. Cairns’s opinions are also not conclusory as argued, but are supported with evidence from the patent and the prior art as noted. Ex. 2036 ¶¶ 62–67. slip op. at 83
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“have wanted to combine Amin’s and Wang’s coatings, Petitioner simply does not provide an adequate, evidence-backed analysis of how such person would have predictably done so. As Patent Owner points out, the evidence on this record raises doubts that the two coatings could have been successfully combined. MTA Reply 6–8. Specifically, evidence of record supports Patent Owner’s argument that a skilled artisan would not have reasonably expected “that the digestive enzymes of Wang could be successfully immobilized on the fluorine-coated surface of Amin.” Id.; Ex. 2036, ¶¶ 6–10; Ex. 2035, 15:5˗19:2. Notably, the testimony of Petitioner’s own declarant supports the conclusion that the combination Petitioner proposes would not have been reasonably predictable—if even possible at all. When Dr. Rozzell was asked if there were other materials (like enzymes) that could be adhered to the surface of Amin’s coatings, he did not know. Ex. 2035: 15:16–17:13 (“[Y]ou don’t know what any of those materials [that might adhere] are, sitting here today? A Not without doing some research on my end.”) (“So turning back to our discussion of immobilizing an enzyme on this [Amin’s coating], you don’t know of a way, today, that you could immobilize an enzyme on top of a fluorine-coated layer. A Well, I’ve personally not done exactly that type of experiment, but I can imagine that there would be approaches that would allow you to do that. Q But you don’t know any of them today? A I can’t tell you one as I’m sitting here today. Q Okay. And you’ve not recalled seeing this in a publication? A No.”).” slip op. at 87
Patent outcomesUS 8,932,717 unpatentableClaim construction§ 103 obviousnesscites Graham · NautilusPatents in suitUS 8,932,717 - Apple Inc. v. Voip-Pal.Com, Inc.Rehearing deniedPTAB · May 24, 2019 · IPR2016-01201 · APJ Scott R Boalick · IPR · Rehearing
The Board denied Apple’s rehearing request, leaving intact the finding that the challenged claims were not shown obvious over the asserted Chu and Chen combinations.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“At the outset, we note that in a request for rehearing we do not review the merits of the Final Written Decision de novo. Instead, we consider whether Petitioner has met its burden of showing that a matter has been misapprehended or overlooked in the Final Written Decision. 37 C.F.R. § 42.71(d) (“The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.”). We conclude that Petitioner has not met this burden in its Request for Rehearing.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“evidence that, in Chu ’684, users would dial according to the dialing conventions of their geographic area. Reh’g Opp’n 8 (citing Ex. 2016 ¶ 66). Patent Owner’s expert witness, Dr. Mangione-Smith, testified that “in Chu ’684, the users would dial PSTN ‘public numbers’ based on the location of the customer premises.” Ex. 2016 ¶ 66 (citing Ex. 1006, Fig. 2). Figure 2 of Chu ’684 supports Dr. Mangione-Smith’s testimony, in that Figure 2 of Chu ’684 illustrates customer premises 105 (which includes IP phones) as connected to a service provider central office 205. See Ex. 1006, Fig. 2; Reh’g Opp’n 9 (contrasting Petitioner’s assertion” slip op. at 4
§ 103 obviousnessPatents in suitUS 8,542,815 - Apple Inc. v. Voip-Pal.Com, Inc.Rehearing deniedPTAB · May 24, 2019 · IPR2016-01198 · APJ Scott R Boalick · IPR · Rehearing
The Board denied Apple’s rehearing request, leaving intact the finding that challenged claims of the ’005 and ’815 patents were not shown obvious over the asserted combinations.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“At the outset, we note that in a request for rehearing we do not review the merits of the Final Written Decision de novo. Instead, we consider whether Petitioner has met its burden of showing that a matter has been misapprehended or overlooked in the Final Written Decision. 37 C.F.R. § 42.71(d) (“The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.”). We conclude that Petitioner has not met this burden in its Request for Rehearing.” slip op. at 2
- Expert testimonyPatent owner expert creditedDecided for patent owner
“view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“view of Chu ’684. See Reh’g Opp’n 7–10 (relying on its declarant to argue that Chu ’684 does not operate as asserted by Petitioner, undermining Petitioner’s justification for the combination); PO Resp. 70 (citing Ex. 2016 ¶ 66). Petitioner contends that Dr. Mangione-Smith’s testimony did not address the asserted combination and therefore provided no need for a reply declaration. Reh’g Reply 7–8. We do not agree with Petitioner’s position, for the reasons stated above. Petitioner does not raise any basis on which we should discount the panel’s reliance on Dr. Mangione-Smith’s testimony regarding the reason to combine.7 We conclude that the panel did not misapprehend Chu ’684’s operation when it concluded that the Petition failed to show Chu ’684 is deficient and ripe for improvement. Instead, it resolved a factual dispute in Patent Owner’s favor based on record evidence.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“testimony by Dr. Mangione-Smith—when rejecting Petitioner’s view of the prior art and reason for the combination. See FWD 19 (citing Ex. 2016 ¶¶ 65–67); Reh’g Opp’n 6. Thus, when the panel concluded that Petitioner had not shown that Chu ’684’s method would apply to a number reformatted by the secondary references (see FWD 22–23), it relied on record evidence supporting its conclusion. We determine that the panel did not misapprehend the nature of the proposed combination; rather, based on the record, it resolved a factual dispute and concluded that Petitioner failed to show the proposed combination would operate as asserted.” slip op. at 5
§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,179,005 - Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Indivior UK LimitedRehearing deniedPTAB · Jun 23, 2017 · IPR2016-01113 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied rehearing of its decision denying institution because the petition did not show the claimed local pH range was known or obvious.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). The request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). A party who requests rehearing bears the burden of showing that a decision should be modified. Id. II.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“obviousness analysis. In stating that Petitioner did “not point to where the SBOA, the Suboxone® 2002 Label, and/or LabTec suggest that anyone actually measured a local pH for the Suboxone tablets in an oral cavity, much less determined that local pH should be from about 3 to about 3.5, as recited in the challenged claims,” we addressed Petitioner’s reliance on those three references as collectively teaching or suggesting the claim limitations “[a] buffer in an amount to provide a local pH” of “about 3 to about 3.5.” Dec. 13 (citing Pet. 27–32). We concluded that those three references did not provide sufficient evidence to establish those claim limitations as known prior art elements. See id. at 13–14. Petitioner is incorrect that we ignored teachings in those three references concerning pH. Rather, we considered the Suboxone® Label’s disclosure of a buffering system consisting of citric acid and sodium citrate and Petitioner’s contention, relying on Dr. Çelik’s testimony, that a citric acid and sodium citrate buffer operates within the range of 3.0 to 6.2. Id. at 12–13 (citing Pet. 31–32). We also considered the SBOA’s disclosure of in vitro dissolution studies identifying redacted pH values, and Petitioner’s conclusion based on the SBOA, “that in order for buprenorphine to dissolve, the local pH of the saliva had to be below a certain value, and for naloxone to dissolve, the pH had to be above a certain value because the solubility profiles of these drugs are dependent on pH.” Id. at 11 (quoting Pet. 29); id. at 13 (citing Pet. 29–32). And we further considered LabTec’s disclosure of the relationship between pH and absorption. Id. at 11 (citing Pet. 27–28); id. at 17. We found, however, insufficient evidence to support a conclusion that a local pH value for Suboxone® in the oral cavity or a local pH range of about 3 to about 3.5 were known or obvious. Id. at 11–14.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We considered Petitioner’s argument that “‘it would have been nothing more than routine experimentation’ to identify ‘the claimed pH range of 3 to 3.5 as optimal.’” Id. at 16 (quoting Pet. 33). As we discussed in our Decision, however, the relationship between pH and absorption that LabTec discloses is that “[f]or a basic active ingredient, one would adjust the pH of the solution to below the pKa of the conjugate acid” as a “means for retarding absorption of the active ingredient through the oral mucosa.” Id. at 17 (alteration in original) (emphasis omitted) (quoting Ex. 1007, at 15). In other words, for a basic active ingredient like buprenorphine, this teaching suggests to lower the pH where the goal is to retard oral absorption. See id.; see also Ex. 1009, at 28 (describing buprenorphine as a “weak base” and stating that “[a]bsorption of lipophilic weak bases should increase with salivary pH increases”). As such, as noted in our Decision, LabTec does not suggest preparing a film that lowers a local pH to 3–3.5 in the saliva for the purpose of increasing absorption of an active ingredient such as buprenorphine. Dec. 17. In contrast, the claims of the ’832 patent require adjusting the local pH to “optimize absorption of said buprenorphine,” and the specification further explains that “[i]n a dosage form that is to be placed in the oral cavity, it is desired to absorb the agonist [buprenorphine] buccally, so as to provide rapid integration of the agonist into the body of the user.” Ex. 1001, 11:10–13, 23:65–67, 24:33–35.” slip op. at 6
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We disagree with Petitioner that we erred in finding Dr. Çelik’s statement that the “anatomy of the oral and nasal mucosa is quite similar, thus, one of ordinary skill would expect that the same principle of drug delivery will apply to both tissues” (Ex. 1003 ¶ 105) is merely conclusory. In the Request for Rehearing, Petitioner argues that Dr. Çelik’s testimony in the same paragraph as this statement provides support. Req. Reh’g 12 (citing Ex. 1003 ¶ 105). We have reviewed this paragraph of Dr. Çelik’s declaration, however, and we find that with the exception of the paragraph’s final sentence (which is the statement at issue), the entirety of the paragraph is a summary of Birch’s disclosures and concerns delivery to the nasal mucosa. See Ex. 1003 ¶ 105. Before the final sentence of the paragraph, the testimony in this paragraph fails to mention oral mucosa, let alone provide reasoning or support for why Dr. Çelik concludes that “[t]he anatomy of the oral and nasal mucosa is quite similar” or why it would have been expected “that the same principle of drug delivery will apply to both tissues.” See id.” slip op. at 8
§ 103 obviousnessPatents in suitUS 8,475,832 - J Kyle Bass / Erich Spangenberg v. Fresenius Kabi USA, LLCAll claims unpatentablePTAB · Jun 7, 2017 · IPR2016-00254 · APJ Tina E Hulse · IPR · Final written decision
Claims 1, 13–15, 17, 18, 20, and 24–28 are unpatentable as obvious over each of two combinations: Diprivan PDR and Farinotti with van den Heuvel or Lundgren.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“In our Decision to Institute, we adopted Patent Owner’s definition, given the claims recite compositions of propofol in a container. Dec. Inst. 5. 1 Physicians’ Desk Reference, Product Identification Guide and Product Information for Diprivan, 341, 2939–45 (1997) (“Diprivan PDR,” Ex. 1005). 2 R. Farinotti, Interactions physicochimiques et mode de conservation du Diprivan ® [Physio-Chemical Interactions and Storage of Diprivan®], 13 Ann. Fr. Anesth. Reanim. 453–56 (1994) (Ex. 1006). Citations to Farinotti in this Decision are to the certified translation provided as Ex. 1007. 3 J.G. van den Heuvel, US 5,383,864, issued Jan. 24, 1995 (Ex. 1010). 4 Lundren et al., WO 00/12043, published Mar. 9, 2000 (Ex. 1031). addition to the definition was appropriate. PO Resp. 5 (citing Ex. 2035, 203:11–15). Based on the complete trial record, we see no reason to deviate from our prior definition of a person of ordinary skill in the art. That is, we adopt the level of ordinary skill set forth by Patent Owner. Moreover, we note that the prior art itself further demonstrates the level of skill in the art at the time of the invention. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 5
- Expert testimonyPetitioner expert creditedPatent owner expert creditedOther
“The record shows Dr. Feinberg has some experience with emulsion drug products (Ex. 2035, 16:15–21), with the use of siliconization to improve manufacturing efficiency with drug products (id. at 26:6–27:20), and possibly with propofol, although Dr. Feinberg could not recall (id. at 23:8–24:23). Dr. Davis admits he does not have experience in filling and packaging of pharmaceutical products, but testifies that a person of ordinary skill in the art, as necessary, would consult someone with such experience. Ex. 1043, 37:15–38:12. experience with propofol and drug product emulsions, emulsion systems, and their packaging. Dr. Feinberg has less experience than Dr. Davis with propofol and emulsions, whereas Dr. Davis has less experience than Dr. Feinberg with pharmaceutical packaging. Given their relative experiences, we decline to discount the opinion of either declarant based solely on their differing areas of expertise.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Moreover, having considered the complete trial record, we determine that it is unnecessary to expressly construe any additional claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We are not persuaded by Patent Owner’s argument. It is well settled that “[a] suggestion, teaching, or motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art, as the teaching, motivation, or suggestion may be implicit from the prior art as a whole, rather than expressly stated in the references.” In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006) (emphasis added). That the prior art does not include explicit reports of manufacturing issues with Diprivan rubber stoppers in particular is not fatal to Petitioner’s argument. We are persuaded by the weight of the evidence that it was understood by a person of ordinary skill in the art that rubber stoppers generally have issues with friction during manufacturing, which is commonly cured by adding silicone oil to the stoppers. See, e.g., Ex. 1004, S4 (“Machinability is greatly improved through the use of lubricated packaging components. Siliconization of rubber products reduces the friction present between the rubber closure and with silicone oil, [which] reduces considerably the inherent tackiness in many rubber formulations. The main advantage of a silicone oil coat is that it facilitates the stoppering operation by lubricating the passage of the closures through assembly machines and insertion into the barrel or vial opening.”); Ex. 1002 ¶¶ 20–22.” slip op. at 14
Patent outcomesUS 8,476,010 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,476,010 - Lupin Ltd. / Lupin Pharmaceuticals Inc. v. Pozen Inc.Rehearing deniedPTAB · May 24, 2017 · IPR2015-01774 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied rehearing, leaving its denial of institution on the §103 grounds for claims 1–6 and 13–15 unchanged because Petitioner showed no abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“determined that Petitioner had not established a reasonable likelihood that it would prevail in showing the unpatentability of challenged claims 1–6 and 13–15 of U.S. Patent 8,852,636 B2 (Ex. 1001, “the ’636 patent”) on any of the five grounds advanced in the Petition (Paper 4, “Pet.”). Paper 15 (“Decision” or “Dec.”). Subsequently, Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively “Petitioner”) filed a Request for Rehearing (Paper 16, “Reh’g Req.” or “Request”) asking us to reconsider our Decision denying an inter partes review on two of the grounds advanced in the Petition: (1) whether claims 1–6 and 13–15 are unpatentable under 35 U.S.C. § 103(a) over Chen1 and Gimet;2 and (2) whether claims 1–6 and 13–15 are unpatentable under 35 U.S.C. § 103(a) over Gimet, Chandramouli,3 and Phillips.4” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 3
§ 103 obviousnessPatents in suitUS 8,852,636 - Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentablePTAB · Mar 22, 2017 · IPR2016-01245 · APJ Francisco C Prats · IPR · Final written decision
Claims 1–13 were not shown unpatentable because the petitioner failed to establish obviousness over the instituted combinations.
RulingsFinal written decision- Strike new argumentNew argument disregardedNew argument consideredMixed
“As provided in 37 C.F.R. § 42.23(b), a “reply may only respond to arguments raised in the corresponding opposition or patent owner response.” Thus, “a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned. The Board will not attempt to sort proper from improper portions of the reply.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). One indication that a new issue has been raised in a reply is where a petitioner submits “new evidence necessary to make out a prima facie case” of unpatentability of an original claim. Id.; see also Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir. 2016) (Board did not err or abuse its discretion in declining to consider new contentions and evidence in reply advanced to supplement unpatentability rationale presented in petition).” slip op. at 5
- Skill levelSkill level petitioner adoptedDecided for petitioner
“1. Level of Ordinary Skill in the Art Petitioner contends that the relevant art is medicinal chemistry. Pet 12. As to the level of ordinary skill in that art as of March 15, 1996 (the earliest possible priority date of the ’551 patent), Petitioner contends as follows: [A] POSA [person of ordinary skill in the art] would have a Ph.D. in organic or medicinal chemistry and at least a few years of experience in medicinal chemistry, including in the development of potential drug candidates. Ex. 1002, ¶ 13 [Wang Decl.]. The POSA would also include a person having a Bachelor’s or Master’s degree (organic chemistry or medicinal chemistry) if such a person had more years of experience in medicinal chemistry and the development of potential drug candidates. Id. With experience in drug development, the POSA would have an appreciation of the diseases and ailments a particular drug candidate is intended to treat, but would not necessarily be a medical doctor or clinician. The POSA would know how to evaluate the physical and biological properties of chemical compounds and would be able to conduct, or otherwise have access to resources that could conduct, in vitro and in vivo evaluations of biological and toxicity properties of chemical compounds. Id. Pet. 12. Patent Owner does not controvert Petitioner’s characterization of the relevant art, or the level of ordinary skill in that art, nor does Patent Owner advance a specific assertion of its own as to the level of ordinary skill. See, generally, PO Resp. Accordingly, when evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration Petitioner’s assertions regarding the level of ordinary skill. We also consider that the cited references provide evidence as to the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“We agree with Patent Owner (PO Resp. 38) that, given Kohn 1991’s teaching that “stringent steric and electronic requirements exist for maximal anticonvulsant activity in this class of compounds” (Ex. 1012, 2447), the expected substantial change to the conformation of the overall molecule is significant evidence that an ordinary artisan would not have been motivated to replace the methoxyamino group of compound 3l, the most potent compound taught in Kohn 1991, with a methoxymethyl group. In sum, we acknowledge Dr. Wang’s testimony, discussed above, that due to a methoxyamino group’s potential synthetic and stability issues, and uncommonness in commercial pharmaceuticals, an ordinary artisan may have had a reason to replace such a group with a more common and acceptable moiety, such as a methoxymethyl group, in chemical compounds generally. Nonetheless, as also discussed above, the evidence advanced by Patent Owner shows that, as to the specific FAA compounds of Kohn 1991, an ordinary artisan would have understood that compound 3l’s methoxyamino moiety was considered a basic C(α)-amino substituent that conferred significant activity to the compound, and replacement of that moiety with other substituents would have led to a reduction in activity. As also discussed above, Kohn 1991 teaches that “stringent steric and electronic requirements exist for maximal anticonvulsant activity in this class of compounds” (Ex. 1012, 2447), whereas an ordinary artisan would have understood that substituting a methoxymethyl group for the methoxyamino group of Kohn 1991’s compound 3l would result in a compound with a significantly different conformation and biological activity. Thus, assessing Petitioner’s evidence of a more general motivation for substituting a methoxymethyl group for the methoxyamino group of compound 3l, against Patent Owner’s evidence specifically suggesting that an ordinary artisan would not have viewed the posited substitution as being desirable, we find that the weight of the evidence significantly favors Patent Owner’s position. Overall, the evidence before us indicates that an ordinary artisan lacked motivation, as well as a reasonable expectation of success, for making the specific substitution to Kohn 1991’s compound 3l, required to arrive at lacosamide. That is, we agree with Patent Owner that Petitioner has not shown sufficiently that the prior art of record would have suggested making the specific modification to compound 3l required to yield lacosamide.” slip op. at 23
- Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia with nexusDecided for patent owner
“this issue, we agree with Patent Owner (PO Resp. 56–58) that lacosamide satisfied a long-felt but unmet need in that lacosamide has been found to be useful for treating refractory patients for which other antiepileptic drugs were ineffective. Patent Owner’s witness on this issue, Dr. Bazil,20 testifies as follows: For many of my patients, lacosamide is a very important option, and it certainly fills a need in those patients who require a drug with the unique combination of properties as lacosamide possesses. Thus, lacosamide exhibits its biggest advantages in refractory patients. I have had numerous patients who were able to successfully control their seizures with lacosamide, but who had failed to do so previously with other antiseizure drugs. As director of Columbia’s Epilepsy Center, I have also heard many success stories from other neurologists about patients whose seizures were not controlled by other AEDs but were controlled when they switched to lacosamide. Ex. 2038 ¶ 79 (Bazil Decl.).” slip op. at 36
Patent outcomesUS RE38,551 not shown unpatentable§ 103 obviousnesscites KSR · Graham
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.