- Apotex Inc. / Apotex Corp. v. Celgene CorporationInstitution deniedPTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution
The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached
“support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialPatents in suitUS 8,741,929 - Merial, Inc. v. Sergeant’S Pet Care Products, Inc.Rehearing deniedPTAB · Aug 3, 2017 · IPR2016-00798 · APJ Susan L C Mitchell · IPR · Rehearing
The Board denied Merial’s rehearing request, leaving institution denied for claims 1–22 because the evidence did not show that the prior art suggested the claimed cyphenothrin concentration.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. Id. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3 For the foregoing reasons, Petitioner has not demonstrated that we abused our discretion in denying institution of an inter partes proceeding in this case. Consequently, Petitioner’s Request for Rehearing is denied.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We considered this evidence of Dr. Clark’s testimony concerning the teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5
§ 103 obviousnessPatents in suitUS 8,614,244 - PTAB · Apr 21, 2017 · IPR2016-01566 · APJ Zhenyu Yang · IPR · Rehearing
The Board denied Mylan’s rehearing request, finding no abuse of discretion in denying institution because the petition did not show a reasonable likelihood that the cited combination rendered claims 1–22 obvious.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“In sum, in the Petition, Petitioner did not establish a reasonable likelihood that it would prevail in showing the combination of the ’510 publication and Ahrén, Hughes, and/or Brazg would have rendered the subject matter of the challenged claims obvious. On rehearing, we see no error in our findings of fact or conclusions of law. Thus, we conclude that Petitioner has not demonstrated that we abused our discretion in denying institution of the challenged claims. IV. ORDER Accordingly, it is ORDERED that Petitioner’s request for rehearing is denied.” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In sum, in the Petition, Petitioner did not establish a reasonable likelihood that it would prevail in showing the combination of the ’510 publication and Ahrén, Hughes, and/or Brazg would have rendered the subject matter of the challenged claims obvious. On rehearing, we see no error in our findings of fact or conclusions of law. Thus, we conclude that Petitioner has not demonstrated that we abused our discretion in denying institution of the challenged claims. IV.” slip op. at 6
- BurdenDecided for patent owner
“as it argues now in its request for rehearing, that we should apply a legal presumption of obviousness. In fact, the Petition did not cite Galderma, or numerous other opinions of the Federal Circuit, district courts, and the Board, which Petitioner now relies on in its request for rehearing. The Board could not have misapprehended or overlooked an argument that was not made and case law that was not cited in the Petition. In addition, we reiterate, as we stated in our Decision denying institution, in an inter parte review, Petitioner has the ultimate burden of persuasion to prove unpatentability. Dec. 8 (citing 35 U.S.C. § 316(e); Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–79 (Fed. Cir. 2015)). According to Petitioner, Galderma holds “Patent Owner has burden of overcoming obviousness presumption ‘where there is a range disclosed in the prior art, and the claimed invention falls within that range.’” Req. Reh’g 1 (quoting Galderma, 737 F.3d at 737–38). To the extent Petitioner argues for a presumption of obviousness that shifts the burden of persuasion to Patent Owner, such an argument is misplaced. See In re Magnum Oil Tools Int’l Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (stating that the “burden-shifting framework does not apply in the adjudicatory context of an IPR”).” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“In contrast, here, Petitioner relies solely on the teachings of the ’510 publication—a preferred dose of 1 to 100 mg administered “1 to 4 times a day”— to arrive at the claimed dosage of 2.5 mg or 5 mg. The Petition simply does not provide the same type of evidence and context as those in Galderma, sufficient for us to apply the requested presumption.1” slip op. at 4
§ 103 obviousnessPatents in suitUS 9,173,859 - PTAB · Mar 17, 2017 · IPR2016-01563 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Mylan’s rehearing request, leaving trial instituted only for claims 1 and 10; it found the Petition lacked reasoned obviousness analysis for claims 2–9 and 11–26.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We will grant a request for rehearing if the requesting party demonstrates “an abuse of discretion” in the decision. 37 C.F.R. § 42.71(c). However, we will grant a request for rehearing only if the requesting party “specifically identif[ies] . . . the place where each matter [that we misapprehended or overlooked] was previously addressed.” Id. § 42.71(d). After considering Petitioner’s Rehearing Request, our Decision, and the evidence currently of record, Petitioner’s Rehearing Request is denied.” slip op. at 2
- BurdenNot shown unpatentable
“See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3), requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim.”). In Harmonic, the Federal Circuit held that “it was Harmonic’s burden to explain to the Board how Haskell combined with Rossmere rendered the challenged claims unpatentable. With respect to claim 11 of the ’291 patent, Harmonic did not do so.” Id. Petitioner here also did not meet its burden with respect to claims 2–9 and 11–26 of the ’927 patent.” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“In Galderma, for example, the claim recited a “topically applicable pharmaceutical composition comprising 0.3% by weight of [adapalene] . . . Shroot patents disclosed topical adapalene compositions for treating acne “in a preferred range of 0.01%–1%,” including exemplary formulations containing 0.001%, 0.1%, and 1%. Id. at 735–36. The court noted the Shroot patents were listed in the FDA’s Orange Book for “prior art Differin® 0.1% Gel as well as Differin® Gel, 0.3%.” Id. at 735. The court further noted that other prior art references disclosed the use of 0.3% adapalene lotion in an animal model for acne treatment and taught the use of 0.3% adapalene for other skin conditions “without intolerable irritability.” Id. It was in the foregoing context that the court framed the issue as “whether there was motivation to select the claimed 0.3% adapalene composition in the disclosed range.” Id. at 737–38. The Petition here simply does not provide the same type of context and analysis with regard to the claimed linagliptin dosages, sufficient for us to apply the requested presumption.3” slip op. at 6
§ 103 obviousnessPatents in suitUS 8,673,927 - Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentablePTAB · Nov 3, 2016 · IPR2015-01117 · APJ Toni R Scheiner · IPR · Final written decision
Claims 1–12 were not shown unpatentable; Par failed to establish that the asserted obviousness combinations supported calculating dosage using about 60% conversion.
RulingsFinal written decision- BurdenFwd all claims patentableNot shown unpatentable
“In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9
- Expert testimonyDecided for petitioner
“several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies involving the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. Horizon does not take issue with Dr. Sondheimer’s qualifications, and we find Dr. Sondheimer qualified to provide opinions on the subject matter at issue.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. 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)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11
Patent outcomesUS 8,642,012 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 8,642,012 - Merial, Inc. v. Sergeant’S Pet Care Products, Inc.Institution deniedPTAB · Sep 29, 2016 · IPR2016-00798 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that claims 1–22 were unpatentable over the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“we find that Petitioner has failed to show a reasonable likelihood of success that any of the challenged claims are unpatentable. The key limitation missing from any teaching or suggestion of the combination is “3% to 16% (w/w) cyphenothrin” (or any narrower range therein) combined with fipronil. Sirinyan provides a formulation using fipronil and cyphenothrin, but expressly states that cyphenothrin should be used in a concentration range of from 30 to 60% by weight, which is well outside of any of the claimed ranges for cyphenothrin in the challenged claims. As Patent Owner points out, a lower range within the claimed range is called out for other α- cyanopyrethroids with the possible use of a synergist (that is not required in the challenged claims), but not for cyphenothrin. Prelim. Resp. 7–8, 21, 29– 32. We agree with Patent Owner that Petitioner has failed to show why one of ordinary skill in the art would ignore the express teaching of Sirinyan and lower the concentration of cyphenothrin to a claimed range in a formulation with fipronil. Garden does not provide any such impetus. As Patent Owner states, Garden describes the activity of cypermethrin and alphacypermethrin (two particular species of the α-cyanopyrethroid genus) without fipronil and without additionally providing any specific teaching with respect to cyphenothrin except to include it in a listing as an α-cyanopyrethroid. Prelim. Resp. 8 (citing Ex. 1006, Examples 1-15); Ex. 1006, 2:15–33 (stating preferred compounds include cyphenothrin). The listing of cyphenothrin as one of a list of preferred pyrethroids, without more, would not suggest to one of skill in the art that a lower amount of cyphenothrin should be used in a formulation with fipronil.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Sirinyan provides a formulation using fipronil and cyphenothrin, but expressly states that cyphenothrin should be used in a concentration range of from 30 to 60% by weight, which is well outside of any of the claimed ranges for cyphenothrin in the challenged claims. As Patent Owner points out, a lower range within the claimed range is called out for other α- cyanopyrethroids with the possible use of a synergist (that is not required in the challenged claims), but not for cyphenothrin. Prelim. Resp. 7–8, 21, 29– 32. We agree with Patent Owner that Petitioner has failed to show why one of ordinary skill in the art would ignore the express teaching of Sirinyan and lower the concentration of cyphenothrin to a claimed range in a formulation with fipronil. Garden does not provide any such impetus. As Patent Owner states, Garden describes the activity of cypermethrin and alphacypermethrin (two particular species of the α-cyanopyrethroid genus) without fipronil and without additionally providing any specific teaching with respect to cyphenothrin except to include it in a listing as an α-cyanopyrethroid. Prelim. Resp. 8 (citing Ex. 1006, Examples 1-15); Ex. 1006, 2:15–33 (stating preferred compounds include cyphenothrin). The listing of cyphenothrin as one of a list of preferred pyrethroids, without more, would not suggest to one of skill in the art that a lower amount of cyphenothrin should be used in a formulation with fipronil.” slip op. at 12
- PTAB / AIA Trials › Real party in interest / privityNot reached
“E. Real Parties-In-Interest Patent Owner asserts that Merial Limited, Merial LLC, and Sanofi had a measure of control over this proceeding requiring them to be named as real parties-in-interest. Pet. 9–17. Because we have found that Petitioner has failed to show a reasonable likelihood that it would prevail on any challenged claim, we need not address whether these parties constitute real parties-in-interest. Lumentum Holdings, Inc. v. Capella Photonics, Inc., IPR2015-00731, slip op. at 5 (PTAB March 2, 2016) (holding satisfying the requirements of 35 U.S.C. § 312(a) is not jurisdictional). Any real party-ininterest issue is moot.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither party believes that any claim term or phrase needs to be expressly interpreted. See Pet. 10; Prelim. Resp. 5–39 (offering no express 1 PCT App. WO 2008/080542 A2, published Jul. 10, 2008 (Ex. 1004, “Sirinyan”). The Sirinyan reference is a German-language reference. Petitioner provided a certified English-language translation (Ex. 1005). 2 US Patent 4,902,510, issued Feb. 20, 1990 (Ex. 1006, “Garden”). 3 Mark Suarez, EPA Product Performance/Efficacy Review for Sergeant’s Cyphenothrin Squeeze-On for Dogs, Sergeant’s Cyphenothrin + IGR Squeeze-On for Dogs, and Sergeant’s Cyphenothrin + Methoprene Squeeze- On for Dogs, Nov. 7, 2006 (Ex. 1007, “the EPA Review”). constructions). We agree that we do not need to interpret expressly any claim term or phrase to resolve whether a trial should be instituted. See, e.g., 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 4
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,614,244 - Bioactive Laboratories v. BTG International Inc.Rehearing deniedPTAB · Aug 2, 2016 · IPR2015-01305 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied BioActive Laboratories’ rehearing request, leaving institution denied for claims 1–22 because the ’352 patent was not shown to be prior art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS When considering a request for rehearing, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“After reviewing the arguments and evidence presented in the Petition, however, we were not persuaded that Petitioner had shown that the ’352 patent fails to provide proper written description support or enablement for the claims of the ’414 patent. Accordingly, we were not persuaded that the ’352 patent is prior art to the claims of the ’414 patent and declined to institute an inter partes review on grounds based on the ’352 patent. Dec. 10–11.” slip op. at 3
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable
“anticipated by, and claims 8 and 19 are unpatentable over U.S. Patent No. 4,489,352 (Ex. 1004, “the ’352 patent”). Petitioner acknowledged that the ’352 patent “is listed in the priority chain on the face of the ’414 patent” (Pet. 5), and that the specifications of the ’352 patent and the ’414 patent are identical (id. at 29), but argued that: [T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“[T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
Claim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 8,048,414 - Teva Pharmaceuticals USA, Inc. v. Indivior UK LimitedInstitution deniedPTAB · Jun 10, 2016 · IPR2016-00280 · APJ Jacqueline Wright Bonilla · IPR · Institution
The Board denied institution because Teva did not show a reasonable likelihood that claims 1–7 and 9–12 were unpatentable under § 103(a).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“requesting an inter partes review of claims 1–7 and 9–12 of U.S. Patent No. 8,475,832 B2 (Ex. 1001, “the ’832 patent”). Paper 1 (“Pet.”). Indivior UK Limited (“Patent Owner”) filed a Preliminary Response. Paper 16 (“Prelim. Resp.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” We determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of any claim challenged in the Petition. Accordingly, we decline to institute an inter partes review.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner
“A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004).” slip op. at 8
- Obviousness (§103) › Analogous artNon analogous artNot shown unpatentable
“In any case, as Patent Owner notes, Petitioner relies on Birch where it provides information about the pharmacokinetic profiles of buprenorphine formulations administered intranasally, i.e., Birch “teaches that a pH range of 3.4 can be used for nasal absorption,” not oral transmucosal absorption relevant to a film dosage. Prelim. Resp. 33. All figures and examples in Birch cited in the Petition, and by Petitioner’s expert, Dr. Das, relate to formulations administered intranasally. Ex. 1004, Figs. 1–4, ¶¶ 38–39, Examples 1, 3, 5, ¶¶ 139–154, Example 8, ¶¶ 206–211; Ex. 1003 ¶¶ 80, 102– 03. Petitioner does not indicate sufficiently if or where Birch discusses oral transmucosal absorption, or how pH information in relation to nasal absorption might be relevant to oral transmucosal absorption or local pH in saliva as generated by a buffer in a film. Pet. 29–30 (citing Ex. 1004, Figs. 1 and 3, Ex. 8; Ex. 1003 ¶¶ 80, 102–03). Thus, Petitioner does not explain adequately how Birch’s pH information in relation to buprenorphine formulations administered intranasally teaches or suggests a buffer providing a specific “local pH . . . in the presence of saliva” as it pertains to a film composition comprising both buprenorphine and another drug, naloxone, as required in the challenged claims. At most, Petitioner cites a paragraph in Dr. Das’s Declaration that states, without itself citing evidence in support, 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 ¶ 80; Pet. 29–30. We agree with Patent Owner that this conclusory statement by Dr. Das, without more, is insufficient to make the leap Petitioner asks us to make. Prelim. Resp. 33 (citing 37 C.F.R. § 42.65(a) (stating that “[e]xpert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight”)). Moreover, Patent Owner points us to evidence in Birch itself indicating that buprenorphine pharmacokinetics differ when administered to oral versus nasal mucosa. Id. at 33–34 (citing Ex. 1004, 16, Table 11).” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Neither Petitioner nor Dr. Das explains adequately, however, why an ordinary artisan would have wanted to try to make a film that produced a local pH of 3 to 3.5 in saliva in the first place, based on LabTec’s teachings regarding the Suboxone® tablet and/or Yang’s teachings regarding general methods for making films. See, e.g., Ex. 1003 ¶¶ 108, 109, 116, 117 (asserting that arriving at a pH of 3–3.5 would have been “routine experimentation,” and “[t]here would not have been anything surprising” about identifying a pH of 3–3.5, without disclosing underlying facts or data in support, other than to refer to Cmax and AUC values for buprenorphine); Pet. 30–31.9 9 In a footnote, Petitioner discusses Dr. Das’ assertion that a “person of ordinary skill would have known that she had to consider the solubility of Moreover, as Patent Owner points out (Prelim. Resp. 8), LabTec teaches that “formulations can rely on various means for retarding absorption of the active ingredient through the oral mucosa,” including by using “pH adjusting agents that adjust the pH of the environment surrounding the dosage form to a pH that renders the active agent less permeable.” Ex. 1007, 15. In this context, LabTec states that “[s]uitable pH adjusting agents function by ionizing the active agent to a less permeable state,” and “for a basic active ingredient, one would adjust the pH of the solution to below the pKa of the conjugate acid.” Id.; Prelim. Resp. 2, 9–10 (discussing the effect of pH on buprenorphine, a “weakly basic compound”). In view of such teachings, Patent Owner persuades us that 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. Upon consideration of information presented in the Petition and the” slip op. at 15
§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,475,832 - E. I. Du Pont De Nemours And Company / Archer-Daniels-Midland Company v. Furanix Technologies B.V.Rehearing deniedPTAB · May 24, 2016 · IPR2015-01838 · APJ Christopher G Paulraj · IPR · Rehearing
The Board denied rehearing and left in place the denial of institution on the obviousness challenge to claims 6 and 10 based on the cited references.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Petitioners have not demonstrated that we misapprehended or overlooked any of the arguments or evidence presented in the Petition with respect to claims 6 and 10. We previously considered the cited teachings of the ’018 patent highlighted in Petitioners’ reconsideration request, but did not find any support for Petitioners’ contention that “ester-acid derivatives of HMF” or “products [that] can be further oxidized to form . . . FDCA” refer to esters of HMF, as opposed to esters of FDCA. Decision, 17. As we previously noted, an ester of FDCA is not the same as an ester of HMF. Id. (citing Ex. 1009 ¶¶ 22–23, 32). Moreover, Petitioners’ additional arguments relying upon statements made during prosecution are unpersuasive insofar as the Petition did not rely upon or cite to the prosecution history to support its obviousness arguments for claims 6 and 10. Petition, 40–45. A request for rehearing is not an opportunity to present new arguments not previously presented in the Petition. III.” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Not reached
“a reasonable likelihood that the cited prior art teachings render obvious the requirement in dependent claims 6 and 10 that the feed used for the preparation of 2,5-furan dicarboxylic acid (“FDCA”) comprises an ester of 5-hydroxymethylfurfural (“HMF”). We noted that Petitioners relied primarily upon the teaching of the ’018 patent in which an “ester derivative” refers to the formation of an ester of FDCA (e.g., 5-(alkoxycarbonyl) furancarboxylic acid (AcMFA)), not the use of an ester of HMF to form FDCA as required by claims 6 and 10. Decision, 16–17. Although we recognized that Example 15 of the ’018 patent separately describes the oxidation of acetoxymethylfurfuryl, we noted that Petitioners failed to provide any explanation of the relevance of this teaching other than a single cursory citation in the Petition. Id. at 17 (citing Petition 42, Ex. 1004, 12:9– 16).” slip op. at 3
- Strike new argumentNew argument disregardedDecided for patent owner
“overlooked any of the arguments or evidence presented in the Petition with respect to claims 6 and 10. We previously considered the cited teachings of the ’018 patent highlighted in Petitioners’ reconsideration request, but did not find any support for Petitioners’ contention that “ester-acid derivatives of HMF” or “products [that] can be further oxidized to form . . . FDCA” refer to esters of HMF, as opposed to esters of FDCA. Decision, 17. As we previously noted, an ester of FDCA is not the same as an ester of HMF. Id. (citing Ex. 1009 ¶¶ 22–23, 32). Moreover, Petitioners’ additional arguments relying upon statements made during prosecution are unpersuasive insofar as the Petition did not rely upon or cite to the prosecution history to support its obviousness arguments for claims 6 and 10. Petition, 40–45. A request for rehearing is not an opportunity to present new arguments not previously presented in the Petition. III.” slip op. at 4
NonePatents in suitUS 8,865,921 - Square, Inc. v. Think Computer CorporationRehearing grantedPTAB · Feb 9, 2016 · CBM2014-00159 · APJ Michael W Kim · CBM · Rehearing
The Board granted Patent Owner’s rehearing request insofar as it addressed the assertions in the decision, but denied it in all other respects; the prior analysis remained unchanged.
RulingsRehearing decision- RehearingRehearing, grantedGranted in part
“A request for rehearing can only point out that which the Board misapprehended or overlooked, and will be reviewed for abuse of discretion. 37 C.F.R. § 42.71(d). Moreover, as the moving party, the burden of persuasion falls on Patent Owner. 37 C.F.R. § 42.20(c). The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and where each matter was previously addressed in a motion, an opposition, or a reply. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012).” slip op. at 1
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“are unpersuaded that they would alter our construction. For example, Patent Owner asserts that the claim limitation “any particular transaction” requires that “bidirectional account” be construed as allowing an account to function simultaneously as both a merchant account and a purchaser account under all transactions. We disagree, primarily because we are unclear as to what Patent Owner means by “under all transactions.” The relevant limitation of independent claim 1 reads “wherein the first account and the second account are adapted to selectively function as either a merchant or a purchaser account during any particular transaction.” We find that “[a]ny particular transaction” means any specific transaction, and is not necessarily limited to all transactions going forward, and find further that, logically, an account need only function in “merchant mode” or “purchaser mode” for that particular transaction; otherwise the account would be in the awkward position of performing a transaction with itself. Moreover, we are unclear as to why the same account cannot function as both, depending on the transaction, as an account is merely a repository within which funds are held, and whether the account is in “merchant mode” (i.e., the ability to send funds from the account) or “purchaser mode” (i.e., the ability to send funds to the account) does not alter the fundamental repository nature of the account itself. A similar analysis of the cited portions of the prosecution history and Specification yields similar conclusions. For example, Patent Owner’s discussion of the prosecution history on pages 4 and 5 of the Request for Rehearing do not amount to Patent Owner providing an explicit definition of “selectively function,” “during any particular transition,” or any other claim term as meaning “simultaneously”; nor do Patent Owner’s statements rise to the level of a clear and unmistakable disclaimer with respect to the meaning of the claim terms.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“2. whether Dalzell fails to meet the claims’ requirements Based on Patent Owner’s proposed claim construction of “bidirectional accounts,” Patent Owner asserts that Dalzell does not disclose “bidirectional accounts.” Req. 7‒10. As we are unpersuaded, however, that the Board misapprehended or overlooked the items identified by Patent Owner in construing “bidirectional accounts,” we are unpersuaded that our analysis of Dalzell and “bidirectional accounts” set forth on pages 28 to 29 of the Final Written Decision should be modified in any way. See Dec. 29 (“[W]e find that a more logical reading of paragraph 59 of Dalzell is that a buyer, from a particular account, can add a seller feature to that particular account, without the need to create a whole new account. Such a finding is supported by extensive analysis and testimony by Dr. Sadeh-Koniecpol, with explicit citations to Dalzell, which we find credible, reasonable, and persuasive. Ex. 1002 ¶¶ 147-164 (citing Ex. 1006 ¶¶ 9, 27, 49, 57, 61, 82, 85, 87, 132, 163, Figs. 1A, 1B).”)” slip op. at 9
Claim construction§ 103 obviousnessPatents in suitUS 8,396,808
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.