• Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.No claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 10,195,214
• Argentum Pharmaceuticals LLC / Mylan Pharmaceuticals Inc. et al. v. Research Corporation Technologies, Inc.No claims unpatentable
  PTAB · Mar 22, 2017 · IPR2016-01242 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–13 were not shown unpatentable: Petitioner failed to establish obviousness of claims 1–9 over Kohn 1991 and Silverman, or claims 10–13 over those references and the ’729 patent.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In an inter partes review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). Based on the record developed in this proceeding, we conclude that Petitioner has not established by a preponderance of the evidence that claims 1–9 of the ’551 patent are unpatentable for obviousness over Kohn 1991 and Silverman, nor has Petitioner established by a preponderance of the evidence that claims 10–13 of the ’551 patent are unpatentable for obviousness over Kohn 1991, Silverman, and the ’729 patent. slip op. at 4

  • Strike new argumentNew argument disregardedDecided for patent owner

    “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

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “Petitioner relies on the uncorroborated testimony of its expert, Dr. Wang, as support for its contention that compound 3l’s methoxyamino group is an uncommon moiety among commercial pharmaceuticals that presents potential synthetic and stability issues, and also for its contention that the posited substitute, a methoxymethyl group, is a more common and acceptable moiety for pharmaceutically active compounds. See Pet. 44–45; see also Ex. 1002 ¶¶ 106, 107 (Wang Decl.) (citing no documentary support). As stated in 37 C.F.R. § 42.65(a), “[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.” We, nonetheless, acknowledge Dr. Wang’s education and experience (Ex. 1002 ¶¶ 6–10, Appendix A), and note that Patent Owner does not dispute specifically the accuracy of Dr. Wang’s assertions in this regard. We thus acknowledge that, as a general principle in the art of medicinal chemistry, an ordinary artisan seeking to develop a commercial pharmaceutical compound ordinarily would have considered the substitution of a methoxyamino group with another more common and acceptable moiety, particularly because of any potential synthetic and stability issues associated with the methoxyamino group in the compound. Petitioner, however, does not identify a specific reason as to why that substitution would have been considered desirable for any of the prior art anticonvulsant compounds taught by Kohn 1991, let alone compound 3l identified as the lead compound.” slip op. at 18

  • 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

  Patent outcomesUS RE38,551 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01853 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703, claims 1–3, 5–8, and 10–41 of the ’826, claims 1–8 of the ’685, and claims 1–40 of the ’437 were not shown unpatentable under § 103.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing 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))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “We are persuaded by Dr. Hayes’ testimony as confirmed by testimony from Drs. Pleasure and Polli, and conclude that the Provisional supports the CavSS ranges in claims 14–15 and 35–36. Dr. Hayes offers credible 34 testimony concerning how one of skill in the art would interpret Table 7 of the Provisional, which depicts essentially the same data as Table 3 of Hayes. See Ex. 2041 ¶ 17. Dr. Hayes interpretation of the data in Table 7 is supported by testimony from Drs. Pleasure and Polli that about two thirds of the measured data fall within one standard deviation and approximately 95 percent of measured values are within two standard deviations from the mean. Id. at 20–22 (citing deposition testimony from Drs. Pleasure and Polli confirming such an understanding). We agree with Dr. Hayes that “[i]n light of the fact that a POSA would immediately recognize that Table 7 of the ’894 Provisional (Ex. 1007-00045) shows possession of measured data beyond even two standard deviations from its reported mean values, a more complete view of the information reported in Table 7 would consider data dispersed beyond two standard deviations from the mean” to encompass a CavSS range from 3.7–37.8 ng/ml. Ex. 2041 ¶ 23. We are not persuaded by Dr. Fairweather’s testimony that Table 7 supports a CavSS of only 15.1 ng/ml to 26.5 ng.ml. See Ex. 1066 ¶ 21. Dr. Fairweather was asked if he could identify where “range” is defined as plus or minus one standard deviation, and he replied that he could not identify where he found such a definition, Ex. 2176, 44:13–22, but Dr. Fairweather confirmed such a definition is not how he would define “range” in his usual practice, Id. at 92:20–93:21. See also id. at 108:5–11 (conceding there may not be any document that defines “range” as one 35 standard deviation from the mean). When asked whether he could justify the range that he provided for CavSS in his declaration, Dr. Fairweather stated that he could not. Id. at 104:25–105:2. He testified that he conceded the smallest range so as to avoid a discussion of what’s the proper definition for range. Id. at 104:16–20. Dr. Fairweather stated twice that he was not a person of skill in the art and would not be able to answer what assumptions such a person would make when reviewing Table 7 of the Provisional. Id. 136:16–23, 138:14–139:7. Finally, Dr. Fairweather also testified that he could not rule out whether the CavSS data for the 10 mg b.i.d. dose described in Table 7 of the Provisional had a range of at least 15 to 35 ng/ml. Id. at 90:9–92:19. In light of these statements, we do not credit Dr. Fairweather’s testimony.” slip op. at 34

  Patent outcomesUS 8,007,826 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,007,826
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01850 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703 patent were not shown unpatentable because S-1 was not prior art under § 102(a) or (b), defeating each instituted § 103 ground.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing 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))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37

  Patent outcomesUS 8,440,703 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,440,703
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01858 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–40 of the ’437 patent were not shown unpatentable under § 103 because S-1 was not prior art under § 102(a) or (b).

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc.,” slip op. at 14

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing 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))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “We agree with Patent Owner that the Provisional provides adequate written description support for the challenged claims of the ’703 patent. We agree with Drs. Lublin and Peck and credit their testimony that one of skill in art reading the Study Design schematic for Example 11 would have understood that a patient in the 10 mg b.i.d. arm of the study would have received 10 mg b.i.d. throughout the two-week upward titration period. As 10 mg b.i.d. is the lowest dose except for placebo, we find that it necessarily 30 follows that those patients in the 10 mg b.i.d. arm of the study do not need upward titration to the treatment dose because they start and finish at the lower 10 mg dose.” slip op. at 30

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “Although the burden of persuasion for unpatentability never shifts from Petitioner during the trial, the burden of production may shift. See Dynamic Drinkware, 800 F.2d at 1379. Petitioner adequately met its burden of production by presenting S-1 as prior art that on its face lists authors that differ from the inventors of the patents at issue. See Ex. 1003, 92. Patent Owner has responded with ample and persuasive evidence, however, that Drs. Blight and Cohen are the sole source of the disclosure of S-1. Thus, Patent Owner satisfies any burden of production to refute Petitioner’s case that S-1 is prior art under 35 U.S.C. § 102(a). See supra. Petitioner’s response to Patent Owner’s evidence does not persuade us that the portions of S-1 upon which they rely are not solely attributable to Drs. Blight and Cohen. Specifically, Petitioner offers evidence from the S-1 of a statement that the MS-F202 clinical trial was designed “after extensive consultation with a panel of expert MS neurologists and with the FDA,” arguing that statement indicates that Drs. Blight and Cohen may not be the sole authors 41 of the protocol for this clinical trial. Reply 2. Petitioner further argues that Drs. Blight and Cohen’s deposition testimony supports its contention that Drs. Blight and Cohen may not be the sole authors of the protocol for this clinical trial because they could not recall the details of that consultation. Id. at 3 (citing Ex. 1064, 64:18–65:14; Ex. 1063, 76:20–77:20, 80:9–81:14, 110:13–111:2). Petitioner also takes issue with another statement in S-1 indicating that in early 2002, Drs. Blight and Cohen drafted descriptions of the MS-F201 and MS-F202, although version 1.0 of the MS-F202 protocol is dated October 2002. Id. at 2 (citing Paper 28, 16; Ex. 2050, 6). Finally, Petitioner points to publications discussing MS-F201 and MS-F202 where Drs. Blight and Cohen are not consistently named as authors and other authors, such as Drs. Goodman and Katz, are listed. Id. at 3–4. We find that Petitioner’s evidence that allegedly casts doubt on the authorship of the relevant portions of S-1 is not sufficient to overcome the ample, unequivocal evidence presented by Patent Owner that supports our finding that the relevant portions of S-1 are the original work of Drs. Blight and Cohen alone. See In re Katz, 687 F.2d at 455. Both Drs. Cohen and Blight state that they alone are the inventors and sole originators of the work in S-1 upon which Petitioner relies. See Exs. 2044, 2045. Five other declarants, intimately involved in the development of S-1, two of which now work for entities other than Acorda, substantiate this testimony. See Exs. 2046–2048, 2052, 2056. Relying on statements that may, on their face,” slip op. at 41

  Patent outcomesUS 8,354,437 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,354,437
• Nintendo Of America, Inc. / Nintendo Co., Ltd. v. Ilife Technologies, Inc.No claims unpatentable
  PTAB · Apr 28, 2016 · IPR2015-00109 · APJ Hyun J Jung · IPR · Final written decision

  Claims 1–3, 9–12, and 18–20 were not shown unpatentable under § 103 over Yasushi because Yasushi was not prior art.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner

    “Turning first to the express language of independent claims 1 and 10, claim 1 recites a “system within a communications device capable of evaluating movement of a body relative to an environment . . . wherein said communication1 device transmits said tolerance indicia,” and claim 10 recites a “method for operating a system within a communications device . . . wherein said method comprises the steps of . . . transmitting said tolerance indicia through said communications device.” We, thus, agree with Patent Owner that claims 1 and 10 only require the “communications device” to transmit tolerance indicia. The ’796 patent also states that the “term ‘communication device’ is defined broadly to include, without limitation, cellular telephones, personal digital assistants, hand held computers, laptops, computers, wireless Internet access devices, and other similar types of communications equipment.” Ex. 1001, 2:46–50. Because of the qualifiers “broadly,” “without limitation,” and “other similar types of communications equipment,” we do not find that the ’796 patent’s purported definition of “communication device” limits the” slip op. at 12

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “describes that “[s]ystem 11 includes circuit boards 13 and 15 . . . associated with a housing (generally designated 17),” that “[h]ousing 17 may comprise . . . halves 19 and 21 that encase boards 13 and 15,” and that “[s]ystem 11 includes a processor . . . and a sensor 25.” Ex. 1007, 39:10–12, 39:16–19, 40:4–5; see also Ex. 1001, 5:25–28, 5:32–36, 5:45–46. Figure 2 illustrates system 11, “which includes processing circuitry 39, indicating means 41, . . . along with sensor 25” and shows sensor 25 on board 15 within housing 17. Ex. 1007, 42:18–21; see also Ex. 1001, 6:48–51. The grandparent application also describes that an “[e]xemplary indicating means 41 . . . [is] operable to . . . communicate such state, or tolerance, indicia to a monitoring controller,” that “[i]ndicating means 41 may take any number of forms,” and that “in system 11 of the present embodiment, stage 41 is an RF transmitter.” Ex. 1007, 43:14–20. Based on these descriptions of system 11 with an RF transmitter, we find that the grandparent application provides adequate written description support for the “communications device” recited by the challenged claims.” slip op. at 19

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “In order to receive benefit of the filing date of an application previously filed in the United States, the subsequent application for patent must be for an invention disclosed in the manner provided in 35 U.S.C. § 112, first paragraph. 35 U.S.C. § 120; see also 37 C.F.R. § 1.78; see Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998) (discussing requirements of claiming benefit of priority date of earlier application under 35 U.S.C. § 120).3 To satisfy 35 U.S.C. §112, first paragraph, the written description must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the claimed invention. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991). One shows “possession” of the invention by describing the invention using such descriptive means as words, structures, figures, diagrams, formulas, etc. that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). The issue of whether the written 3 The subsequent application must also be filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the previously filed application and contain or be amended to contain a specific reference to the previously filed application. 35 U.S.C. § 120; see also 37 C.F.R. § 1.78. In this case, the application that matured into the ’796 patent was filed on December 30, 2002, which is before the patenting of the parent application on December 31, 2002, which was similarly entitled to the benefit of the filing date of the grandparent application. Ex. 1001, 1; Ex. 1007, 8. The application that matured into the ’796 patent contained a specific reference to the grandparent application. Ex. 1006, 38. description requirement has been satisfied is a question of fact. Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865 (Fed. Cir. 1993).” slip op. at 17

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference not prior artDecided for patent owner

    “overcome Yasushi’s publication date.4 See In re Facius, 408 F.2d 1396, 1403–04 (CCPA 1969) (holding, in a prosecution context, that an earlier filed reference was prima facie available as prior art and placing the burden on the party claiming prior invention to overcome that reference). Patent Owner may meet its burden by providing evidence that the publication date of the reference is not “before the invention thereof by the applicant for [a] patent,” 35 U.S.C. § 102(a), that is, antedating Yasushi. Yasushi was published on November 10, 1998. As described above, claims 1–3, 9–12, and 18–20 of the ’796 patent are entitled to a priority date of September 15, 1999. Thus, Yasushi is available as prior art against these claims under 35 U.S.C § 102(a) unless Patent Owner establishes (i) a reduction to practice before November 10, 1998, or (ii) conception before November 10, 1998, followed by a diligent reduction to practice. Purdue Pharma L.P. v. Boehringer Ingelheim GMBH, 237 F.3d 1359, 1365 (Fed. Cir. 2001) (“To antedate . . . an invention, a party must show either an 4 Even though Patent Owner bears the burden of production in antedating a reference, the burden of persuasion to prove unpatentability of the challenged claims remains with Petitioner. See 35 U.S.C. § 316(e). earlier reduction to practice, or an earlier conception followed by a diligent reduction to practice.”) (emphasis added) (citation omitted). Reduction to practice is a question of law predicated on subsidiary factual findings. Brown v. Barbacid, 276 F.3d 1327, 1332 (Fed. Cir. 2002). To establish an actual reduction to practice, the inventor must prove that: (1) an embodiment of the invention was constructed that meets all the limitations of the claims at issue; and (2) the inventor appreciated that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998). The invention does not have to be at a commercially satisfactory stage of development for an actual reduction to practice, but must have been sufficiently tested to demonstrate that it will work for its intended purpose. See, e.g., Scott v. Finney, 34 F.3d 1058, 1062 (Fed. Cir. 1994) (citing numerous cases wherein the character of the testing necessary to support an actual reduction to practice varied with the complexity of the invention and the problem it solved). It is well settled that an inventor’s testimony alone is insufficient to” slip op. at 22

  Patent outcomesUS 6,864,796 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
  Patents in suitUS 6,864,796
• Biodelivery Sciences International, Inc. v. Monosol RX, LLCNo claims unpatentable
  PTAB · Mar 24, 2016 · IPR2015-00165 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127 were not shown unpatentable over Chen because the evidence did not establish the claimed active-component uniformity.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In an inter partes review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). We conclude that Petitioner has not proved by a preponderance of the evidence that claims 1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125–127, of the ’167 patent are unpatentable for anticipation under 35 U.S.C. § 102(b) by Chen. slip op. at 3

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

    “We find that the instant inter partes review under the AIA offers a significant procedural opportunity to the parties that was not available in the prior inter partes reexamination proceeding of the ’588 patent cited by Petitioner. Specifically, inter partes reexamination proceedings are conducted essentially by the same procedure as routine examination of patent applications. 37 C.F.R. § 1.937(b). Although normal examination procedure allows for submission of evidence in affidavit form (37 C.F.R. §§ 1.131, 1.132), the rules for inter partes reexaminations do not provide for cross-examination of those affiants. See 37 C.F.R. §§ 1.902–1.997. In contrast, in the instant proceeding, witnesses presenting direct testimony by affidavit are subject to cross-examination via deposition. 37 C.F.R. § 42.53. Indeed, as discussed herein below, the testimony on cross-examination of one of Petitioner’s witnesses uncovered facts significant to our evaluation of the issue of anticipation, resulting in a determination on that issue different from the prior ’588 reexamination appeal decision cited by Petitioner. Thus, the availability of cross-examination of witnesses in this inter partes review under the AIA is a significant procedural opportunity for Patent Owner that is not present in the prior inter partes reexamination proceeding, and that procedural distinction indeed yields a result different from that in the prior inter partes reexamination. In addition, we also find that the instant situation does not meet the requirements for applying issue preclusion, because resolution of the issue in this case was not essential to the final judgment in the ’588 decision. As to that requirement, in Freeman the court noted that “statements regarding the scope of patent claims made in a former adjudication should be narrowly construed.” In re Freeman, 30 F.3d at 1466. With that in mind, we note again that the limitation at issue in claim 1 of the ’167 patent states that the “substantially uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said active component.” Ex. 1001, 41:19–22. In the prior ’588 decision, because Patent Owner had not argued any claims separately, the Board resolved the issue of whether Chen met the uniformity requirement based on claim 1 of the ’588 patent. Ex. 1027, 12 (the ’588 decision).5 In contrast to the language at issue here, claim 1 of the ’588 patent, as amended, required only “substantially uniform content of therapeutic active composition per unit of film.” Ex. 1027, 4. Thus, the ’588 decision did not resolve the issue of whether Chen met the 5 In citing to the ’588 decision we cite to the original page numbers of the decision, not the pages numbers entered by Petitioner as part Exhibit 1027. substantial uniformity requirement based on the claim language at issue in this proceeding. We acknowledge the statement in the ’588 decision that, as to claim 3 of the ’588 patent, the “weight deviation” described in Example 1 of Chen “is well within the less than 10% variation of active content per film unit requirement of claim 3” of the ’588 patent. Ex. 1027, 19. As noted immediately above, however, the ’588 decision resolved the uniformity issue based on claim 1 of the ’588 patent, not on claim 3, which depends from claim 1.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther

    “drying process,” claim 1 expressly recites that the controlled drying process, which produces the film, rapidly forms a viscoelastic matrix to lock-in the active component in place within the matrix to maintain the above-discussed substantially uniform distribution. Ex. 1001, 41:13–16. Accordingly, contrary to Petitioner’s contentions (see Pet. 10–11), we conclude that claim 1 does limit the conditions of the “controlled drying process.” As noted above, moreover, the ’167 patent discusses the advantages of the controlled drying process, including the faster drying times. Ex. 1001, 6:61–7:1. According to the Specification, “[d]esirably, the drying of the film will occur within about ten minutes or fewer, or more desirably within about five minutes or fewer.” Id. at 7:1–3. It further discloses that the initial film setting period, “during which a solid, visco-elastic structure is formed . . . can take place within the first few minutes, e.g. about the first 0.5 to about 4.0 minutes of the drying process.” Id. at 24:52–56. Thus, contrary to Petitioner’s contention, the ’167 patent does provide a standard for the term “rapidly” as recited in claim 1. Especially given the express language in the claims, we conclude that the claims encompass a film having a structure which would result from a controlled drying process which forms a viscoelastic matrix within a few minutes of the drying process to lock-in the active component within the matrix, the film having a substantially uniform distribution of the active component, measured by substantially equally sized individual unit doses which do not vary by more than 10% of the desired amount of the active component.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “Because visual inspection is not the measure of uniformity recited in claim 1 of the ’167 patent, Petitioner does not persuade us that it is reasonable to construe the uniformity limitation at issue in claim 1 as being met by a visual evaluation, based on the ’292 patent’s disclosure that substantial uniformity (as opposed to the claimed uniformity of distribution with a variation of no more than 10%) can be verified visually. We acknowledge that the passage cited above in column 20 of the ’292 patent describes actual testing of the amount of active component as an “alternative” method of verifying substantial uniformity. Ex. 1035, 20:62. Petitioner does not persuade us, however, that it is reasonable to construe the measure of uniformity in claim 1 of the ’167 patent, which requires a determination of the amount of active component in equal size dosage units, as being met by a method (simple visual inspection) which no evidence has shown is capable of quantifying the active component amount.” slip op. at 19

  Patent outcomesUS 8,765,167 not shown unpatentable
  Claim construction§ 102 anticipationcites Phillips
  Patents in suitUS 8,765,167
• Biodelivery Sciences International, Inc. v. Monosol RX, LLCNo claims unpatentable
  PTAB · Mar 24, 2016 · IPR2015-00169 · APJ Francisco C Prats · IPR · Final written decision

  Claims 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87, 93, 110–116, and 124 were not shown unpatentable over Chen and Tapolsky because substantial active-component uniformity was not established.

  RulingsFinal written decision

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

    “We find that the instant inter partes review under the AIA offers a significant procedural opportunity to the parties that was not available in the prior inter partes reexamination proceeding of the ’588 patent cited by Petitioner. Specifically, inter partes reexamination proceedings are conducted essentially by the same procedure as routine examination of patent applications. 37 C.F.R. § 1.937(b). Although normal examination procedure allows for submission of evidence in affidavit form (37 C.F.R. §§ 1.131, 1.132), the rules for inter partes reexaminations do not provide for cross-examination of those affiants. See 37 C.F.R. §§ 1.902–1.997. In contrast, in the instant proceeding, witnesses presenting direct testimony by affidavit are subject to cross-examination via deposition. 37 C.F.R. § 42.53. Indeed, as seen herein, the testimony on cross-examination of one of Petitioner’s witnesses uncovered facts significant to our evaluation of the disclosure of the Chen reference, resulting in a determination on that issue different from the prior ’588 reexamination appeal decision cited by Petitioner. Thus, the availability of cross-examination of witnesses in this inter partes review under the AIA is a significant procedural opportunity for Patent Owner which is not present in the prior inter partes reexamination proceeding, and that procedural distinction indeed could likely yield a result different from that in the prior inter partes reexamination.” slip op. at 17

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “drying process,” claims 17 and 110 expressly recite that the controlled drying process, which produces the film, rapidly forms a viscoelastic matrix to lock the active component in place within the matrix to maintain the above-discussed substantially uniform distribution. Ex. 1001, 43:60–63 (claim 17), 48:21–24 (claim 110). Accordingly, contrary to Petitioner’s contentions (see Pet. 10–11), we conclude that claims 17 and 110 do limit the conditions of the “controlled drying process.” As noted above, moreover, the ’167 patent discusses the advantages of the controlled drying process, including the faster drying times. Ex. 1001, 6:61–7:1. According to the Specification, “[d]esirably, the drying of the film will occur within about ten minutes or fewer, or more desirably within about five minutes or fewer.” Id. at 7:1–3. It further discloses that the initial film setting period, “during which a solid, visco-elastic structure is formed . . . can take place within the first few minutes, e.g. about the first 0.5 to about 4.0 minutes of the drying process.” Id. at 24:52–56. Thus, contrary to Petitioner’s contention, the ’167 patent does provide a standard for the term “rapidly” as recited in claims 17 and 110. Especially given the express language in the claims, we conclude that the claims encompass a film having a structure which would result from a controlled drying process which forms a viscoelastic matrix within a few minutes of the drying process to lock-in the active component within the matrix, the film having a substantially uniform distribution of the active component, measured by substantially equally sized individual unit doses which do not vary by more than 10% of the desired amount of the active component.” slip op. at 8

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Having considered the parties’ arguments and supporting evidence, we find, for the reasons that follow, that Petitioner has not shown by a preponderance of the evidence that the film compositions described in Chen meet the requirement in claims 17 and 110 of a substantially uniform distribution of the active component, measured by substantially equally sized individual unit doses which do not vary by more than 10% of the desired amount of the active component.” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “Neither Petitioner nor Dr. Cohen, however, directs us to a clear or specific teaching in Modern Coating that the measure of “uniformity” described therein (Ex. 1009, 268) is the same measure as that required by claims 17 and 110 of the ’167 patent, that is, a distribution of active component that varies by less than 10% between substantially equal size dosage units, as opposed to merely a uniform thickness. Moreover, neither Petitioner nor Dr. Cohen directs us to any clear or specific teaching in Modern Coating demonstrating that the films discussed therein actually satisfy the uniformity requirement of claims 17 and 110. Nor does Petitioner direct us to specific evidence, such as experimental test results, showing that any of the drying processes described in Modern Coating necessarily produce a film meeting the uniformity requirement of claims 17 and 110. That “[m]odern precise coating applicators can [maintain uniformity] for most coatings” (Ex. 1009, 268 (emphasis added)) at best demonstrates a degree of likelihood that Chen’s films would meet the standard of uniformity of Modern Coatings. As noted above, however, one may not rely on probabilities or possibilities to show that a reference inherently meets a limitation. In re Oelrich, 666 F.2d at 581. In addition, Petitioner does not explain specifically, in either the Petition or in the Cohen Declaration, which particular variables, of the many Dr. Cohen admits would have been recognized as amenable to optimization, would have been optimized, or would have been critical to producing the substantially uniform active component distribution required by claims 17 and 110. We find, therefore, that Petitioner has not explained with adequate specificity how or why an ordinary artisan would have reasonably expected to be able to obtain a film having the required uniform active agent distribution. See In re Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009) (discussing that one circumstance in which the prior art fails to provide a reasonable expectation of success is where the art suggests “vary[ing] all parameters or try[ing] each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful”) (quoting In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988) (emphasis omitted)). In sum, for the reasons discussed, we find that Petitioner has not shown that, based on the homogeneity of Chen’s coating solutions, Chen inherently describes films that meet the uniformity requirement of claims 17 and 110, nor are we persuaded that Petitioner has shown that an ordinary artisan had a reasonable expectation of success in producing such films.” slip op. at 29

  Patent outcomesUS 8,765,167 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 8,765,167
• Biodelivery Sciences International, Inc. v. Monosol RX, LLCNo claims unpatentable
  PTAB · Mar 24, 2016 · IPR2015-00168 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 16, 36, 42, 48, 55, 62, 69, 76, 86, 92, 122, and 123 were not shown unpatentable as obvious over Chen in view of Tapolsky.

  RulingsFinal written decision

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

    “Under the doctrine of collateral estoppel, also known as issue preclusion, a judgment on the merits in a first proceeding precludes relitigation in a second proceeding “of issues actually litigated and determined in the first [proceeding].” In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994). Issue preclusion is appropriate only if: (1) the issue is identical to one decided in the first action; (2) the issue was actually litigated in the first action; (3) resolution of the issue was essential to a final judgment in the first action; and (4) the party against whom issue preclusion is asserted had a full and fair opportunity to litigate the issue in the first action. Id. When applying issue preclusion, “statements regarding the scope of patent claims made in a former adjudication should be narrowly construed.” Id. at 1466. We determine that issue preclusion does not apply here because the resolution of the issue in this case was not essential to the final judgment in the ’588 decision. In the ’588 decision, because Patent Owner did not argue for the patentability of any dependent claims separately, the Board resolved the issue of whether Chen met the uniformity requirement solely based on 12 the language of claim 1. Ex. 1027, 12. Claim 1 of the ’588 patent, as amended during the reexamination, requires “substantially uniform content of therapeutic active composition per unit of film.” Id. at 4. Thus, the ’588 decision did not resolve the issue of whether Chen met the substantially-uniform-distribution limitation, “measured by substantially equal sized individual unit doses which do not vary by more than 10% of said desired amount of said active component,” as required by claim 16 of the ’167 patent.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “In the Decision to Institute, we also stated the phrase including the term “controlled drying process” refers to drying with at least one controlled drying parameter, which forms a viscoelastic matrix within a few minutes of the drying process to lock-in the active within the matrix and to maintain the distribution of the active so that substantially equal sized individual unit doses do not vary by more than 10% of the amount of the active. Dec. 8–9 (emphasis added). As Patent Owner correctly points out, claim 16 recites “substantially equal sized individual unit doses which do not vary by more than 10% of said desired amount of said active component.” Ex. 1001, claim 16 (emphasis added); PO Resp. 5. We agree with Patent Owner that the omission of the word “desired” in our construction is inconsistent with the express language of claim 16. See PO Resp. 5. Thus, we modify our construction of the term “controlled drying process” and conclude that the phrase including the term “controlled drying process” refers to drying with at least one controlled drying parameter, which forms a viscoelastic matrix within a few minutes of the drying process to lock-in the active within the matrix and to maintain the distribution of the active so that the resulting film has a substantially uniform distribution of the active, as measured by substantially equal sized individual unit doses do not vary by more than 10% of the desired amount of the active. 6 We, however, disagree with Patent Owner on what the term “desired amount” means. Patent Owner asserts that the “desired amount” of active is the “labeled amount of active.” See PO Resp. 16–17, see also id. at 20 (“[T]he term ‘desired amount’ means the dosage (label) amount.”). According to Patent Owner, “[t]his and only this interpretation is consistent with” the Specification of the ’167 patent. Id. at 17. We are not persuaded. Patent Owner relies on the Background section of the ’167 patent where it discloses: “Currently, as required by various world regulatory authorities, dosage forms may not vary more than 10% in the amount of active present.” Id. at 18 (quoting Ex. 1001, 2:1–20). According to Patent Owner, “[i]n order for individual unit doses containing drugs to be legally sold they must contain, according to the prescribed limits, the drug in the desired dosage amount, also commonly referred to as the labeled dosage amount.” Id. Patent Owner may well be correct in that statement. Yet, the argument does not impact our patentability analysis of claim 16 and its dependent claims, because the challenged claims are not limited to pharmaceutical films, much less such films that are regulated because they contain a “labeled” dosage amount. Indeed, claim 16 recites “said active component is selected from the group consisting of cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof.” Patent Owner does not explain, and we are not aware, what a labeled dosage is for a film with a cosmetic agent or a vitamin as the active component. Moreover, if we were to, as Patent Owner insists, limit the “desired amount” to the labeled dosage, then such a film, even with a 7 homogeneous distribution of the active component, would be considered non-uniform simply because it does not have a labeled dosage required by the regulatory authorities. Such a construction would not be reasonable.” slip op. at 6

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “We are not persuaded by either argument. Claim 16 recites that the “substantially uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said 17 desired amount of said active component.” Based on the express language of the claim, and despite that we disagree with Patent Owner that the “desired amount” should be limited to the labeled dosage amount, we conclude that the actual amount of the active component in substantially equal sized individual unit doses of the film must be determined in order to evaluate whether the distribution of the active is substantially uniform. Petitioner does not explain how the amount of the active component in each individual unit dose can be ascertained by either visual inspection of a film or weighing the dosage units.” slip op. at 17

  • Expert testimonyPetitioner expert discountedOther

    “Dr. Cohen, however, does not assert that a skilled artisan would have been able to produce film with any particular desired degree of (or absolute) uniformity. And he does not explain what the “high degree of uniformity” he and his colleagues were able to achieve, and whether it satisfies the substantially-uniform-distribution requirement recited in claim 16 of the ’167 patent, that is, as measured by substantially equally sized individual unit doses having the active component that do not vary by more than 10% of the desired amount. Similarly, Petitioner does not argue that the “uniform film” produced according to the drying processes taught in Modern Coating meets this limitation.4 In addition, Dr. Cohen does not opine, Petitioner does 4 Petitioner does not present any other persuasive evidence, such as its own testing data, to demonstrate that the drying processes described in Modern Coating would necessarily result in a film with “substantially uniform distribution” of the active, as required in the challenged claims. See, e.g., 20 not assert, and we do not find, that an ordinary artisan would have understood an unspecified degree of uniformity as satisfying the “substantially uniform” required in the challenged claims.” slip op. at 20

  Patent outcomesUS 8,765,167 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 8,765,167
• Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc.No claims unpatentable
  PTAB · Jul 22, 2015 · IPR2014-01365 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1, 2, 6, 12–14, 17, 21–51, and 54–71 were not held unpatentable over Maloney or Oshlack and the Handbook.

  RulingsFinal written decision

  • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

    “inter partes review of claims 1, 2, 6, 12–14, 17, 21–43, 45–51, and 54–82 of U.S. Patent No. 8,329,216 (“the ’216 patent”). Paper 1 (“Pet.”). Endo Pharmaceuticals Inc. (“Patent Owner”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). As authorized (Paper 9), Petitioner filed a Reply to the Preliminary Response addressing the issue of whether Petitioner was served with a complaint alleging infringement of the ’216 patent more than one year before the Petition was filed, and, therefore, subject to a bar under 35 U.S.C. § 315(b). Paper 11. Patent Owner filed a Surreply on this issue. Paper 14. We determined that § 315(b) did not bar institution in this case. Paper 15, 10.” slip op. at 2

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted in part

    “Meanwhile, Petitioner filed a second Petition requesting inter partes review of claims 5, 16, 44, 46, 47, and 72–82 of the ’216 patent. IPR2014-01365, Paper 2 (“Second Petition”). On the same day, Petitioner filed a Motion for Joinder, requesting joinder of the Second Petition with the Petition in the instituted proceeding. IPR2014-01365, Paper 3 (“Joinder Motion”), 1–2. We granted Petitioner’s Motion for Joinder in relation to the ground that claims 44 and 47 of the ’216 patent would have been obvious over Oshlack and the Handbook, but not in relation to any asserted grounds regarding claims 5, 16, 46, and 72–82 in the Second Petition. IPR2014-00360, Paper 64, 2, 15.6 4 Oshlack et al., U.S. Patent No. 5,958,452, “Extruded Orally Administrable Opioid Formulations,” filed Apr. 10, 1997, issued Sept. 28, 1999 (Ex. 1007). 5 William A. Hanson, HANDBOOK OF DISSOLUTION TESTING, v-xii, 1–13, 26–53, 69–91, 111–23 (2d ed. 1991) (Ex. 1008). 6 In our Decision granting Petitioner’s Motion for Joinder In-Part and Instituting Inter Partes Review, we note “[r]egarding claims 46 and 47, as noted by Petitioner, ‘[d]ue to an unintentional inconsistency in claim numbering in the First Petition, trial was instituted for claims 46 and 47 without Petitioner’s specific analysis of these claims in the First Petition.’” Paper 64, 7.” slip op. at 3

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “light of the specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b). There is a “heavy presumption” that a claim term carries its ordinary and customary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). Petitioner offers claim construction of the phrases “controlled release” and “about.” Pet. 4–5. Petitioner notes that the ’216 patent defines “controlled release” as encompassing formulations that “release no more than about 80% of their active pharmaceutical ingredients within 60 minutes” under the claimed dissolution conditions. Id. (citing Ex. 1001, 3:31–33). Petitioner contends that “about” encompasses “at least the standard statistical error” for dissolution testing values. Id. at 5. Patent Owner responds that no claim construction is necessary. PO Resp. 7–8. Based on the record before us, we determine that Petitioner’s proposed constructions are the broadest reasonable construction of the above-mentioned phrases.” slip op. at 9

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “by Petitioner ignores the fact that Petitioner has the burden to establish by a preponderance of the evidence that the “two or three peaks” limitation of claim 1 is inherent to any oxymorphone formulation, as Petitioner asserts when making its case. Pet. 17; Reply 7. We are not persuaded that Petitioner has met its burden in this regard. In pointing to evidence regarding Study A, Patent Owner provides evidence indicating that certain oxymorphone formulations, as tested in Study A, do not present more than one peak of oxymorphone plasma concentration. PO Resp. 19 (citing Ex. 2013, Fig. 1). By contrast, Petitioner and its experts rely on data presented in Figures 5–7 in the ’216 patent to show that all oxymorphone formulations, including IR compositions, exhibit multiple peaks. Pet. 17–19 (discussing Figs. 6 and 7); Ex. 1003 ¶ 84 (stating that “Figure 6 shows peaks at about 3 hours and about 12 hours after administration” for an IR formulation), ¶ 95; Reply 7–8 (citing Ex. 1031 ¶¶ 34–39 (discussing Fig. 5)). The ’216 patent, when discussing Figures 5 and 6, describes IC formulations as showing “a classical curve, with a high and relatively narrow peak, followed by an exponential drop in plasma concentration,” while stating that CR formulations exhibited “triple peaks in blood plasma concentration.” Ex. 1001, 12:58–67 (Fig. 5); 14:47–3 (Fig. 6). Thus, it is not clear from the ’216 patent itself that IC formulations always present a second “peak” at 12 hours, or that the alleged “peak” at 12 hours for the IC formulations, as asserted by Petitioner and its experts, actually signifies a “peak” as it relates to the “two or three peaks within about 12 hours” recited in claim 1.” slip op. at 15

  Patent outcomesUS 8,329,216 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,329,216

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.