• 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
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01857 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–8 of the ’685 patent were not shown unpatentable because S-1 was not prior art, alone or with Hayes or Juarez.

  RulingsFinal written decision

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

    “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 awardedReference not prior artDecided 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

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “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, 42 indicate that others may have been involved without any evidence that others were, in fact, originators of the work in question or inventors is simply not enough to carry Petitioner’s burden to show that the S-1 is prior art under 35 U.S.C. § 102(a). For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9” slip op. at 42

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityNot reached

    “For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9 D. IPR2015-01853; IPR2015-01857; and IPR2015-01858 Petitioner’s patentability challenges to the claims of U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), U.S. Patent No. 8,007,826 B2 (“the ’826 patent”), and U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), at issue in IPR2015-01853, IPR2015-01857, and IPR2015-01858, respectively, essentially raise the same issues presented in the patentability challenge to the claims of the ’703 patent in IPR2015-01850. Therefore, we chose to 9 Because we find that S-1 is not prior art under 35 U.S.C. § 102(a), we need not reach whether S-1 is a printed publication.” slip op. at 43

  Patent outcomesUS 8,663,685 not shown unpatentable
  § 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,663,685
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision

  Claims 1–8 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success using lomitapide in the claimed dosing regimen.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). As to reasonable expectation of success, we agree with Patent Owner that the ordinary artisan would not have had a reasonable expectation of success of combining Pink Sheet with Chang to arrive at the claimed invention. To the extent that Petitioner relies on our Institution Decision, we note that decision was based on the evidence of record at that time. The evidence advanced by Patent Owner during trial, discussed herein, however, tips the scale in favor of a finding different from that set forth in our Institution Decision. slip op. at 36

  • ExcludeMotion to exclude, deniedMixed

    “As to Exhibit 1052, which is the Deposition Transcript of S. David Kimball, and which Patent Owner acknowledges that Petitioner cites in its Reply, Patent Owner argues that it timely objected to the exhibit as an improper duplicate of Exhibit 2304. Mot. Exclude 7. Petitioner responds that Exhibits 2304 and 1052 are the transcripts of Petitioner’s expert. Opp. Mot. Exclude 4. Although acknowledging that the party taking the deposition normally files the transcript, Petitioner asserts that its Reply cites to Ex. 1056, and Patent Owner does not cite to either exhibit. Id. Patent Owner replies that Exhibit 2304 also contains Dr. Kimball’s signed errata sheet and is, thus, the more complete of the two documents. Reply Mot. Exclude. 3. Patent Owner asserts that the citations in Petitioner’s Reply can be updated to reflect the correct exhibit number, if necessary. Id. Given the posture of this proceeding, that is, it is at final written decision, and as Patent Owner notes, the two documents are not exact duplicates, we decline to exclude Ex. 1056, but will allow both Exhibit 1056 and 2034 to remain in the record.” slip op. at 44

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “the unrebutted evidence of commercial success further supports the patentability of the challenged claims. Looking at the entire record before us, we conclude that Petitioner has not meet its burden to establish unpatentability of challenged claims 1‒8 by a preponderance of the evidence over the combination of Pink Sheet and Chang. E. Motion to Amend As discussed above, because we conclude that Petitioner has not demonstrated the obviousness of the claims by a preponderance of the evidence, we need not reach the merits of Patent Owner’s contingent Motion to Amend (Paper 24). We, thus, dismiss the motion a moot.” slip op. at 44

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “biotechnology and medical device companies.” Id. The press release does not even mention Dr. Stein. Thus, there is nothing in the press release suggesting that the ordinary artisan in the cardiovascular/cardiac field, or interested in MTP inhibitors, should attend the presentation. We, therefore, decline to credit Dr. Mayersohn’s testimony that “[a]person of ordinary skill in the art interested in the development of MTP inhibitors could apparently have attended the meeting or accessed the presentation itself via webcast or on the PPD website shortly thereafter” (Ex. 1003 ¶ 25 (citing the PPD Press Release)), as there was nothing in the press release discussing MTP inhibitors. That finding informs our analysis of the factors set forth in Klopfenstein. Thus, although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.” slip op. at 19

  Patent outcomesUS 7,932,268 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,932,268
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01835 · APJ Lora M Green · IPR · Final written decision

  Claims 1–10 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success substituting lomitapide into Pink Sheet’s dosing protocol.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish facts supporting its challenge by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Based on the record before us, we conclude that Petitioner has failed” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner

    “under 35 U.S.C. § 102 “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). “Because there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been 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.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation not foundMixed

    “Although we find this issue to be very close, we find that the Petitioner has established by a preponderance of the evidence that the ordinary artisan would have looked at other MTP inhibitors, such as lomitapide as taught by Chang, that could be used in the dosing protocol taught by Pink Sheet. Specifically, Pink Sheet teaches a dosing method with the MTP inhibitor, implitamide, wherein, as discussed above, the dosing schedule meets the dosing schedule required by claim 1. Ex. 1013. In addition, Pink Sheet discusses MTP inhibitors generally, and notes that they may have efficacy in situations where high-dose statins are ineffective or inadequate, such as homozygous and severe heterozygous familial hypercholesterolemia. Id. Pink Sheet also acknowledges that the toxicity seen with MTP inhibitors may have been due to the high doses used during the clinical trials. Id. Chang discusses the clinical efficacy of MTP inhibitors, including implitapide (BAY-13-9952) and lomitapide (BMS-201038). Ex. 1015, 566. Specifically, Chang discusses the clinical efficacy of CP-346086, and then notes that similar efficacy was reported for implitapide and lomitapide. Id. Given that implitapide and lomitapide are from the same class of therapeutics, that is, MTP inhibitors, and that they are known to have similar clinical efficacy, based on the record before us, we determine that Petitioner has demonstrated a reasonable basis as to why the ordinary artisan would have substituted lomitapide as taught by Chang for implitapide in the method of Pink Sheet.” slip op. at 32

  • Obviousness (§103) › Objective indicia / secondary considerations › Commercial successObjective indicia with nexusDecided for patent owner

    “Initially, we note that Petitioner does not contest that Juxtapid is a commercial success, and, thus, in view of the unrebutted evidence provided by Patent Owner, we find that Patent Owner has established that Juxtapid is a commercial success. As to Petitioner’s argument that the Juxtapid website does not suggest a forced titration, as set forth in our section on claim construction above, we decline to construe independent challenged claim 1 as requiring a forced titration. Moreover, as shown in the table below, the dosing schedule of independent claim 1 encompasses the dosing method that is given to doctors on the Juxtapid website (Ex. 2301, 1):” slip op. at 43

  Patent outcomesUS 8,618,135 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,618,135
• Douglas Dynamics, L.L.C. / Douglas Dynamics, Inc. v. Meyer Products LLCSome claims unpatentable
  PTAB · Mar 1, 2017 · IPR2015-01839 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1, 2, 4–7, 28–31, 36, 38, 39, 43, and 44 are unpatentable under § 103(a); claims 8, 32, 33, and 48–54 were not shown unpatentable.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for patent owner

    “The disclosure of the ’829 patent is expressly addressed to the problem of, and a solution for, unreliable and vulnerable electrical connections caused by splicing auxiliary lights into OEM headlight wiring. The Background of the Invention explains that “[t]raditionally, the auxiliary lights were spliced into the existing wiring for the headlights of the vehicle.” slip op. at 11

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

    “As an initial matter, we observe that whether or not the preamble term “light circuit” is limiting has little bearing on the ultimate disposition of this inter partes review, as it is undisputed that Douglas has identified, for each asserted ground of unpatentability, disclosure of a light circuit. See PO Resp. 11–12. Furthermore, we agree with Douglas that “light circuit” does not connote any structure beyond that explicitly recited in the body of the claims. Indeed, it is unclear that either Meyer or Mr. Ricca disputes such conclusion. For example, Meyer states in its Patent Owner Response that” slip op. at 18

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

    “As a general rule, the words “a” or “an” in a patent claim carry the meaning of “one or more.” Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342–43 (Fed. Cir. 2008). That rule is particularly applicable 15 where, as here, those words are used in combination with the open-ended antecedent “comprising.” See, e.g., Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed. Cir. 1997). “An exception to the general rule that ‘a’ or ‘an’ means more than one only arises where the language of the claims themselves, the specification, or the prosecution history necessitate a departure from the rule.” Baldwin Graphic, 512 F.3d at 1342–43. We discern no such exception here. First, Meyer has not identified, and we do not discern, any requirement in the language of the claims to support the conclusion that the recited “an auxiliary light connector to connect an auxiliary light” must be a single auxiliary light connector.” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “As set forth above, Möller explicitly teaches the incorporation of microprocessors and microcontrollers to improve relay-circuitry-based vehicle electronics systems. Ex. 1006, 4:41–48. Contemporaneous prior art 33 references, including Gould and COP8, disclose advantages obtained through the incorporation of microprocessors and microcontrollers into relay circuitry for controlling end devices, further underscoring that an ordinarily skilled artisan would have sought to modify the relay circuitry of Knepel with the microprocessors and microcontrollers of Möller. See Ex. 1010, 9, 11; Ex. 1011, 14. Moreover, Dr. Neuhalfen testifies, without challenge, that it was well-known at the time of invention of the ’829 patent to use microprocessors to control original vehicle lights, as well as auxiliary lights, and identifies numerous advantages that the proposed combination would afford. Ex. 1014 ¶ 59. Indeed, Meyer’s expert, Mr. Ricca, agrees that it would not have been difficult for an ordinarily skilled artisan to supplement the circuit of Knepel to provide microprocessor control of the relays in that circuit. Ex. 1033, 182:6–11. In view of the teachings of Möller itself, and the contemporaneous prior art, as well as the testimony of Dr. Neuhalfen and Mr. Ricca, we find that a person of ordinary skill in the art at the time of the invention would have recognized the value of using known elements, i.e., microprocessors and microcontrollers, as taught by Möller, to improve the relay circuitry for controlling original vehicle lights and auxiliary lights of Knepel. We likewise find that a person of ordinary skill in the art would have appreciated that the microprocessors of Möller could be incorporated into, i.e., used to supplement, the relay circuitry of Knepel. See KSR, 550 U.S. at 418 (an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account” slip op. at 33

  Patent outcomesUS 6,265,829 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,265,829
• Coalition For Affordable Drugs Vii LLC v. Pozen Inc.No claims unpatentable
  PTAB · Feb 21, 2017 · IPR2015-01718 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–16 were not shown unpatentable over Plachetka, Graham, and Goldstein or Plachetka alone because the claimed comparative ulcer reduction was an unexpected difference in kind.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “Based on the evidence developed at trial, we find that Petitioner has shown that it would have been expected that the method of the challenged claims would be effective in reducing the risk of gastric ulcers in patients taking both LDA and a non-aspirin NSAID. But Petitioner has not established that that the claimed method would have been expected to be more effective in patients taking LDA than in patients not taking LDA, especially in light of evidence of record establishing that patients taking both LDA and a non-aspirin NSAID would be at increased risk for developing gastric ulcers relative to patients taking NSAID alone. We find that this surprising result—the opposite of what the ordinary artisan would have expected—represents a difference in kind, rather than degree. Accordingly, we conclude that Petitioner has not demonstrated by a preponderance of the evidence that the subject matter of claims 1–16 would have been obvious over Plachetka, Graham, and Goldstein.” slip op. at 27

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Pet. 17–18 (citing Ex. 1003 ¶ 83). Paragraph 83 of Dr. Shargel’s Declaration is virtually identical to the Petition. Neither Petitioner nor Dr. Shargel identifies the basis for these purported results in the Petition, or in the cited portion of the Declaration, much less the basis for the conclusion that an ordinary artisan “would have understood that a combination of lansoprazole and naproxen was more effective at reducing the incidence of the NSAID-associated ulcers in patients taking LDA than in patients not taking LDA.” Pet. 18 (citing Ex. 1003 ¶ 83). As we stated in the Decision 20 of Institution, “[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”— accordingly, we are not persuaded by these conclusory and unsupported statements by Petitioner or Dr. Shargel. Dec. 15 (quoting 37 C.F.R. § 42.65(a)).” slip op. at 20

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Nevertheless, the issue presented by Petitioner’s rationale is not whether the cited art would have suggested administering LDA to a patient already taking Plachetka’s unit dosage form. Rather, the salient issue is whether the art would have suggested that a patient already taking LDA in 13 addition to a non-aspirin NSAID—which Goldstein teaches was known to increase the incidence of gastric ulcers—would have benefited by taking the non-aspirin NSAID in the form of Plachetka’s coordinated unit dose form containing an acid inhibitor in addition to the NSAID. Having considered Petitioner’s and Patent Owner’s arguments and observations with respect to this aspect of the challenged claims, as well as evidence of record establishing that administering an acid inhibitor to a patient taking both LDA and a non-aspirin NSAID was known to reduce the incidence of NSAID-associated gastric ulcers, we determine that Petitioner has demonstrated that an ordinary artisan would have had a reason to administer Plachetka’s coordinated unit dosage forms to patients in need of NSAID therapy and at risk of developing gastric ulcers—including those patients also taking low dose aspirin—in order to reduce the incidence of gastric ulcers.” slip op. at 13

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for patent owner

    “Based on the evidence developed at trial, we find that Petitioner has shown that it would have been expected that the method of the challenged claims would be effective in reducing the risk of gastric ulcers in patients taking both LDA and a non-aspirin NSAID. But Petitioner has not established that that the claimed method would have been expected to be more effective in patients taking LDA than in patients not taking LDA, especially in light of evidence of record establishing that patients taking both LDA and a non-aspirin NSAID would be at increased risk for developing gastric ulcers relative to patients taking NSAID alone. We find that this surprising result—the opposite of what the ordinary artisan would have expected—represents a difference in kind, rather than degree. Accordingly, we conclude that Petitioner has not demonstrated by a preponderance of the evidence that the subject matter of claims 1–16 would have been obvious over Plachetka, Graham, and Goldstein.” slip op. at 27

  Patent outcomesUS 8,945,621 not shown unpatentable
  § 103 obviousnesscites Graham
  Patents in suitUS 8,945,621
• Shell Oil Company v. Exxonmobil Research And Engineering CompanyNo claims unpatentable
  PTAB · Feb 21, 2017 · IPR2016-00009 · APJ Elizabeth M Roesel · IPR · Final written decision

  Claims 1–4 were held not unpatentable because Petitioner did not prove Valyocsik disclosed ZSM-48 crystals free from ZSM-50 impurity.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “parties, we find that Petitioner has not shown by a preponderance of the evidence that Valyocsik Example 13 is necessarily free from ZSM-50. Our finding is supported by at least three categories of evidence: (1) Dr. Lobo’s concession that Experiment 5 is an “exception” to his opinion that the XRD data for Mr. Cooper’s reproductions of Example 13 show a ZSM-48 product that is free from ZSM-50 impurity (Ex. 1004 ¶ 96); (2) Dr. Higgins’ analysis of the XRD data for Mr. Cooper’s experiments (Ex. 1009) and conclusion that the data for Experiments 1–5 are consistent with the presence of ZSM- 50 in the samples (Ex. 2013, ¶¶ 33–41); and (3) Dr. Lobo’s concession on cross-examination that the XRD data for Mr. Cooper’s Experiments 1, 3, and 5 include peaks consistent with the presence of ZSM-50 (Ex. 2017, 61:1–62:20, 67:22–75:2). We discuss each category of evidence below:” slip op. at 16

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

    “First, it is inconsistent with the legal standard for inherency, which requires Petitioner to show that the product of Valyocsik Example 13 is necessarily free from ZSM-50 impurity. Robertson, 169 F.3d at 745. Evidence that the product “may in fact be” impurity-free (Pet. Reply 16) is not sufficient. Oelrich, 666 F.2d at 581 (Inherency “may not be established by probabilities or possibilities.”).” slip op. at 21

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “48 crystals that are “free from ZSM-50 and Kenyaite impurities.” After considering the arguments and evidence presented by both parties, we find that Petitioner has not met its burden to prove that Valyocsik discloses, either expressly or inherently, ZSM-48 crystals that are free from ZSM-50 impurity. In view of this finding, we need not address whether Valyocsik discloses ZSM-48 crystals that are free from Kenyaite impurity.” slip op. at 10

  Patent outcomesUS 6,923,949 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 6,923,949
• Fustibal LLC v. Bayer Healthcare LLCInstitution denied
  PTAB · Feb 8, 2017 · IPR2016-01490 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because Riedl was repeatedly considered during prosecution and the petition did not show a reasonable likelihood that claims 1–16 were unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “§ 314(a); 37 C.F.R. § 42.108. Our discretion on whether to institute is guided, in part, by 35 U.S.C. § 325(d), which states that “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Patent Owner requests that the Board exercise its discretion to deny institution with respect to Ground 1 because Riedl was expressly considered by the Examiner during the prosecution of the ’553 Patent. Prelim. Resp. 7–8. As noted in section I(E), above, in allowing claims 1–16 of the ’533 Patent, the Examiner expressly referred to Riedl as the closest prior art, yet found that it “fails to teach . . . the instant claimed compounds.” Ex. 2006, 913; see also Ex. 2005, 397, 569; Ex. 2006, 855 (same, with respect to similar claims).” slip op. at 11

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “As an initial matter, the above argument fails because, as discussed in section I(C)(iii), above, Riedl does not “expressly disclose[] the rografenib compound,” as Petitioner contends. We further agree with Patent Owner’s observation “that the Petition nowhere engages in a ‘lead compound’ analysis” and, at least with respect to Ground 2, “merely assumes—without explanation—that the POSA would select sorafenib for modification.” Prelim. Resp. 22–23. A lead compound comprises “a natural choice for further development efforts” (Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1008 10 Petitioner provides similar arguments with respect to claims 1–12, 14, and 16. Id. at 22–25. (Fed. Cir. 2009)), i.e., a prior art compound “that would be most promising to modify in order to improve upon its . . . activity and obtain a compound with better activity” (Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). “In determining whether a chemist would have selected a prior art compound as a lead, the analysis is guided by evidence of the compound’s pertinent properties.” Otsuka Pharm., 678 F.3d at 1292. “Absent a reason or motivation based on such prior art evidence, mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection.” Id. In setting forth Ground 2, Petitioner invokes a person of ordinary skill in the art “who was looking to modify sorafenib.” Prelim. Resp. 22. Neither Petitioner nor Petitioner’s expert address why a skilled artisan reading Riedl would select that compound for further development. Given that Riedl does not highlight any of the vast number of disclosed compounds as having particularly beneficial properties or present any enzymatic or biological data, we also do not discern from this reference why a person of ordinary skill in the art would have selected sorafenib as “a natural choice for further development efforts.”” slip op. at 17

  • Skill levelSkill level petitioner adoptedOther

    “Person of Ordinary Skill in the Art. Petitioner contends that a person of ordinary skill in the art “typically would have a PhD, MD, MS, or another degree relating to pharmaceutical chemistry (e.g. biology, chemistry, medicinal chemistry, medicine, pharmacology, or a closely related discipline), and . . . would have substantial familiarity, training, or experience with pharmaceutical compositions.” Pet. 6. Patent Owner has not challenged Petitioner’s proposed interpretation of a skilled artisan. We adopt Petitioner’s proposed interpretation for purposes of this opinion. See Prelim. Resp. 6 & n.1; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evident from the prior art). B.” slip op. at 6

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “Petitioner (correctly) contends that the ’553 Patent expressly defines the claim term “pharmaceutically acceptable salt” as “‘a relatively non-toxic, inorganic or organic acid addition salt of a compound of the present invention.’” Pet. 7 (quoting Ex. 1001, 9:56–62). Patent Owner does not presently object to this definition. Based on the specification’s express disclosure, we agree that the cited definition applies. See Prelim. Resp. 6 & n.2. The parties agree that all other terms should be accorded their ordinary and customary meaning. Id.; Pet. 6–7. Our reviewing court counsels that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Accordingly, for purposes of this decision, we determine that no further construction is necessary. C.” slip op. at 7

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 8,637,553
• Swiss Pharma International AG v. Biogen IdecRehearing denied
  PTAB · Feb 3, 2017 · IPR2016-00912 · APJ Lora M Green · IPR · Rehearing

  The Board denied Swiss Pharma’s rehearing request, leaving institution denied for claims 1–16, 21, and 22 because the petition did not show a reasonable likelihood of obviousness.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “however, that the variable to be optimized had to be recognized as a result effective variable. Id. at 620. In the instant case, Petitioner only suggests changing the concentration of the antibody to allow it to be stored in known vials. Petitioner does not explain, however, how merely adding a sufficient concentration of natalizumab to a known vial is a result effective variable. As noted by Patent Owner (Prelim. Resp. 40), Dr. Brod testified that “the concentration of natalizumab is not important from the stand-point of administration as partial, single or multiple vials can be added to an intravenous bag in order to provide the proper dose.” Ex. 1011 ¶ 27. Thus, although the testimony may be read as demonstrating that the concentration is not critical, it also demonstrates that the concentration of the antibody in terms of its storage was not recognized as a result effective variable.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “however, that the variable to be optimized had to be recognized as a result effective variable. Id. at 620. In the instant case, Petitioner only suggests changing the concentration of the antibody to allow it to be stored in known vials. Petitioner does not explain, however, how merely adding a sufficient concentration of natalizumab to a known vial is a result effective variable. As noted by Patent Owner (Prelim. Resp. 40), Dr. Brod testified that “the concentration of natalizumab is not important from the stand-point of administration as partial, single or multiple vials can be added to an intravenous bag in order to provide the proper dose.” Ex. 1011 ¶ 27. Thus, although the testimony may be read as demonstrating that the concentration is not critical, it also demonstrates that the concentration of the antibody in terms of its storage was not recognized as a result effective variable.” slip op. at 8

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We disagree. We noted in our decision that similarly to Soberra, Gordon also taught a 3 mg/ml infusion, and used a 5 mg/ml formulation. Dec. 12‒13. We then looked at the references relied upon by Dr. Schöneich in establishing that formulations were available in stoppered vials in a number of different volumes. Id. at 13. We noted that only one antibody solution was referenced by Dr. Schöneich, and that antibody solution contained 5 mg/ml of antibody. Id. The other references were directed to small molecule drugs, and we noted that Dr. Schöneich did not explain why the ordinary artisan would look to those references when formulating an antibody solution. Id. The fact that Petitioner may not agree with our consideration of the evidence does not mean that we overlooked that evidence, or that we misapprehended it.” slip op. at 11

  § 103 obviousness
  Patents in suitUS 8,815,236
• Swiss Pharma International AG v. Biogen IdecRehearing denied
  PTAB · Feb 3, 2017 · IPR2016-00915 · APJ Lora M Green · IPR · Rehearing

  The Board denied Swiss Pharma’s rehearing request, leaving institution denied for claims 1–4 because the petition did not show a reasonable likelihood of obviousness.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “As noted in our Decision, however, Petitioner failed to demonstrate that the adjustment of the concentration of natalizumab would have been only routine optimization. Dec. 11. Gordon teaches a 5 mg/ml formulation of natalizumab. Id. The other references relied upon by Petitioner to establish that “IgG formulations containing between 5 and 50 mg/ml were known in the art” do not relate to natalizumab, nor are they limited to the claimed excipient, and Petitioner does not address our concern as to how the concentrations of those antibodies could be extrapolated to natalizumab in the claimed excipient. Id. at 10‒12 (quoting Pet. 27). In fact, the references relied upon by Petitioner to teach the claimed excipient, contained 10 mg/ml (van Oosten) or 5 mg/ml (Zenepax) of antibody. Id. at 10. Moreover, Petitioner does not address our concern that two of the three references relied upon by Dr. Schöneich to establish that stoppered vials in different sizes were known related to small molecule drugs, and the one that related to antibodies, Zenepax, contained 5 mg/ml of antibody. See Dec. 12‒13.” slip op. at 7

  • Obviousness (§103) › KSR rationalesMotivation not foundDecided for patent owner

    “The court held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” Id. at 456. The court noted, however, that “changes such as these may impart patentability to a process if the particular ranges claimed produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art.” Id. In concluding that the patentability of the claims was not demonstrated, the court noted that “[a]ny chemist reading the article could logically assume that higher yields might be obtainable, and by experimentally varying the conditions of temperature and acidity could find the most productive conditions.” Id. at 458. In In re Antonie, 559 F.2d 618 (CCPA 1977), the court noted, however, that the variable to be optimized had to be recognized as a result effective variable. Id. at 620. In the instant case, Petitioner only suggests changing the concentration of the antibody to allow it to be stored in known vials. Petitioner does not explain, however, how merely adding a sufficient concentration of natalizumab to a known vial is a result effective variable. As noted by Patent Owner (Prelim. Resp. 40), Dr. Brod testified that “the concentration of natalizumab is not important from the stand-point of administration as partial, single or multiple vials can be added to an intravenous bag in order to provide the proper dose.” Ex. 1011 ¶ 27. Thus, although the testimony may be read as demonstrating that the concentration is not critical, it also demonstrates that the concentration of the antibody in terms of its storage was not recognized as a result effective variable.” slip op. at 7

  • BurdenDecided for patent owner

    “37 C.F.R. § 42.108 relates to institution of inter partes review. 37 C.F.R. § 42.108(c) states: Sufficient grounds. Inter partes review shall not be instituted for a ground of unpatentability unless the Board decides that the petition supporting the ground would demonstrate that there is a reasonable likelihood that at least one of the claims challenged in the petition is unpatentable. The Board’s decision will take into account a patent owner preliminary response where such a response is filed, including any testimonial evidence, but a genuine issue of material fact created by such testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review. A petitioner may seek leave to file a reply to the preliminary response in accordance with §§ 42.23 and 42.24(c). Any such request must make a showing of good cause. 37 C.F.R. § 42.108(c), therefore, applies to those situations in which patent owner submits testimonial evidence to support its preliminary response. In those situations where that testimonial evidence creates an issue of material fact, the evidence will be considered in the light most favorable to the petitioner. Patent Owner did not submit any such testimonial evidence in support of its Preliminary Response in the instant proceeding. Moreover, the rule does not relieve Petitioner of its burden of demonstrating in its Petition a reasonable likelihood that at least one of the challenged claims is unpatentable, such that inter partes review may be instituted. In the instant proceeding, for the reasons discussed in the Decision, we determined that the Petition failed to make such a showing.” slip op. at 11

  § 103 obviousness
  Patents in suitUS 8,349,321

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.