• Roquette Freres, S.A. v. Tate & Lyle Ingredients Americas LLCRehearing denied
  PTAB · Dec 19, 2017 · IPR2017-01506 · APJ Grace Karaffa Obermann · IPR · Rehearing

  The Board denied rehearing, leaving claim 4 in the instituted trial because it had not overlooked the digestibility limitation or the concurrent decision.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “We did not overlook the digestibility limitation in claim 4. Nor did we overlook the decision that we entered concurrently in IPR1507. On the contrary, having determined that Petitioner met the threshold for review of claim 1 of the ’436 patent (Dec. 10), we ordered (as permitted by our authorizing statute) “that trial shall proceed on all other claims challenged as anticipated” or obvious over Shah (Ex. 1008). Id. at 10 (citing 35 U.S.C. § 314(a)), 11 (for obviousness grounds based on Shah). We specifically included those other claims in the trial “without reaching any preliminary findings or conclusions on the merits.” Id. at 10. We pointed out that doing so serves our mission of securing the just, speedy, and efficient resolution of the parties’ dispute. Id. (citing 37 C.F.R. §§ 42.1(b), 42. 108). That action was not inconsistent with any finding in the decision declining to institute trial in IPR1507. Nor does it establish that we overlooked or misapprehended any matter in the Decision entered in this proceeding.” slip op. at 2

  None
  Patents in suitUS 7,608,436
• Fresenius-Kabi USA LLC v. Astrazeneca ABInstitution denied
  PTAB · Dec 11, 2017 · IPR2017-01910 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because Petitioner failed to show a reasonable likelihood that claims 1, 2, 5, and 9 were obvious over the asserted prior-art combinations.

  RulingsInstitution decision

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

    “Principles of Law A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. We are, nevertheless, cautioned not to “rel[y] on hindsight reasoning to piece together elements to arrive at the claimed invention.” In re NTP, Inc. 654 F.3d 1279, 1299 (Fed. Cir. 2011) (“Care must be taken to avoid hindsight reconstruction by using the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.” (internal quotations and citations omitted)). Thus, a finding of obviousness, “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Accordingly, a party petitioning the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). D.” slip op. at 20

  • Other 314aDecided for petitioner

    “There is no doubt that the Petition was prepared using our prior Mylan Decision as a roadmap in an attempt to cure deficiencies that led to our denial of trial in the Mylan IPR. Id. at 9–12. The Petition repeatedly refers to our Mylan Decision, and is structured to address deficiencies that we identified in the record of the prior proceeding. See id. passim. Patent Owner requests that we exercise our discretion to deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 6 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and a different patent (the related ’680 patent). Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits. Nevertheless, we approach this case cognizant that the ’680 patent (at” slip op. at 22

  • Skill levelOther

    “Person of Ordinary Skill in the Art. The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 18; Prelim. Resp. 20. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone-dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). B.” slip op. at 19

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “experiment in McLeskey that involved powdered—not oil-based— fulvestrant. Prelim. Resp. 50 (citing Pet. 24; Ex. 1014 ¶ 45, 52; Ex. 1008, 707, Fig. 8; Ex. 2002 ¶¶ 93, 161–162). Accordingly, we agree with Patent Owner that this new testimony does not address the Board’s question of in vivo bioavailability, which requires an oil-based fulvestrant formulation. Id. (citing Ex. 1011, 28; Ex. 2162, 28; Ex. 2001 ¶¶ 176, 185, 234–243); see Ex. 1046, 729 (Examiner’s finding that “the unexpected solubility and the bioavailability of using the specific solvent mixture as recited have been demonstrated”). Patent Owner asserts that Petitioner attempts to rewrite the plain disclosure of McLeskey, by raising opinion testimony directed to what the McLeskey authors may have “hoped” to achieve. Prelim. Resp. 18 (citing Pet. 56–57). We agree. As Patent Owner points out, the testimony of Dr. El-Ashry “reverses McLeskey’s conclusion of ‘treatment failure’ . . . and instead claims it was a ‘successful treatment.’” Id. at 5. We accord little weight to the testimony of Dr. El-Ashry, which was executed nearly two decades after McLeskey was published, because it runs counter to the statement of McLeskey within its four corners—“treatment failure,” which was reported at or near the time of the experiments. Ex. 1008, 706.” slip op. at 28

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 6,774,122
• Fresenius-Kabi USA LLC v. Astrazeneca ABInstitution denied
  PTAB · Dec 11, 2017 · IPR2017-01912 · APJ Zhenyu Yang · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3, 10, 11, 13, or 20 would have been obvious.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we decline to institute an inter partes review of the ’139 Patent.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denialDenied

    “There is no doubt that the Petition was prepared using our prior Mylan Decision as a roadmap in an attempt to cure deficiencies that led to our denial of trial in the Mylan IPR. See id. at 9–11. The Petition repeatedly refers to our Mylan Decision, and is structured to address deficiencies that we identified in the record of the prior proceeding. See id. passim. Patent Owner requests that we deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 6 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and a different patent (the related ’680 patent). Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits.” slip op. at 22

  • Skill levelSkill level board ownDecided for patent owner

    “ANALYSIS A. Person of Ordinary Skill in the Art The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 17–18; Prelim. Resp. 20. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 19

  • Prior constructionPrior construction adoptedDecided for petitioner

    “In the Mylan IPR, we determined the meaning of several claim terms of the ’680 Patent. See Ex. 1011, 15–18. The parties contend that the terms of the ’139 Patent claims should be interpreted in accord with our prior construction. Pet. 18–19; Prelim. Resp. 20. We agree.” slip op. at 20

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 8,466,139
• Innopharma Licensing, LLC v. Astrazeneca ABInstitution denied
  PTAB · Aug 30, 2017 · IPR2017-00904 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 1, 2, 5, and 9 would have been obvious over the asserted references.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we decline to institute an inter partes review of the ’122 Patent. A.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Decided for petitioner

    “There is no doubt that the Petition was prepared using our prior Mylan Decision as a roadmap in an attempt to cure deficiencies that led to our denial of trial in the Mylan IPR. Id. at 9–11. The Petition repeatedly refers to our Mylan Decision, and is structured to address deficiencies that we identified in the record of the prior proceeding. See id. passim. Patent Owner requests that we exercise our discretion to deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 5 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and a different patent (the related ’680 patent). Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits.” slip op. at 22

  • Skill levelSkill level board ownOther

    “Person of Ordinary Skill in the Art. The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 17; Prelim. Resp. 18. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone-dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). B.” slip op. at 19

  • Prior constructionPrior construction adoptedDecided for petitioner

    “In the Mylan IPR, we determined the meaning of several claim terms of the ’680 Patent. See Ex. 1011, 15–18. The parties contend that the terms of the ’122 Patent claims should be interpreted in accord with our prior construction. Pet. 18–19; Prelim. Resp. 18–19. For the reasons set forth in the Mylan Decision, we agree. See Ex. 1011, 16–18. C.” slip op. at 20

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 6,774,122
• Innopharma Licensing, LLC v. Astrazeneca ABInstitution denied
  PTAB · Aug 30, 2017 · IPR2017-00905 · APJ Zhenyu Yang · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3, 10, 11, 13, and 20 were obvious over the asserted prior-art combinations.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we decline to institute an inter partes review of the ’139 Patent.” slip op. at 2

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

    “As we observed in the Mylan IPR, however, “[i]t is not enough for Petitioner to establish that castor-oil based intramuscular injections of fulvestrant were known; the evidence must provide a reason for one of skill in the art to administer [the claimed] fulvestrant formulation”—which includes specific concentrations of three required excipients in castor oil— “‘intramuscularly’ to” achieve a therapeutically significant blood plasma concentration or dosage “for ‘treating a hormonal dependent benign or malignant disease of the breast or reproductive tract,’ as recited in the challenged claims.” Id. at 29.” slip op. at 24

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “As Patent Owner points out, however, Dr. El-Ashry relies on one experiment in McLeskey that involved powdered—not oil-based— fulvestrant. Prelim. Resp. 48 (citing Pet. 24; Ex. 1014 ¶¶ 45, 52; Ex. 1008, 707, Fig. 8; Ex. 2002 ¶¶ 92, 160–61). Accordingly, we agree with Patent Owner that this new testimony does not address the question of in vivo bioavailability, which requires an oil-based fulvestrant formulation. Id. (citing Ex. 1011, 28; Ex. 2162, 28; Ex. 2001 ¶¶ 176, 185, 234–43); see also Ex. 1046, 729 (Examiner finding that “the unexpected solubility and the bioavailability of using the specific solvent mixture as recited have been demonstrated”). Patent Owner asserts that Petitioner attempts to rewrite the plain disclosure of McLeskey, by raising opinion testimony directed to what the McLeskey authors may have “hoped” to achieve. Prelim. Resp. 17 (citing Pet. 54). We agree. As Patent Owner argues, the testimony of Dr. El-Ashry “reverses McLeskey’s conclusion of ‘treatment failure’ . . . and instead claims it was a ‘successful treatment.’” Id. at 3. We accord little weight to the testimony of Dr. El-Ashry, which was executed nearly two decades after McLeskey was published, because it runs counter to the statement of McLeskey within its four corners—“treatment failure,” which was reported at or near the time of the experiments.” slip op. at 28

  § 103 obviousnesscites KSR
  Patents in suitUS 8,466,139
• Innopharma Licensing, LLC v. Astrazeneca ABInstitution denied
  PTAB · Aug 30, 2017 · IPR2017-00900 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 1–3 and 6 would have been obvious over the asserted combinations.

  RulingsInstitution decision

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

    “Principles of Law A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. We are, nevertheless, cautioned not to “rel[y] on hindsight reasoning to piece together elements to arrive at the claimed invention.” In re NTP, Inc. 654 F.3d 1279, 1299 (Fed. Cir. 2011) (“Care must be taken to avoid hindsight reconstruction by using the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.” (internal quotations and citations omitted)). Thus, a finding of obviousness “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Accordingly, a party petitioning the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). D.” slip op. at 21

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied

    “Patent Owner requests that we exercise our discretion to deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 5 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and, to some extent, a different record. Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits. Nevertheless, we approach this case cognizant that, in the Mylan IPR, we denied institution of inter partes review of all of the claims challenged here. We recognize, moreover, that our prior Mylan Decision addressed essentially the same factual inquiry centered on substantially the same asserted prior art references. We accept, therefore, Petitioner’s view that the nub of this dispute is whether “[f]our differences” set forth in the Petition overcome the shortcomings we previously identified in the Mylan Decision. Pet. 9–11; see Ex. 1011, 19–30 (Mylan Decision, including our prior analysis of essentially the same issues raised in the instant Petition).” slip op. at 23

  • Prior constructionPrior construction adoptedDecided for petitioner

    “interpreted according to their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard). Under that standard, we presume that a claim term carries its “ordinary and customary meaning,” which “is the meaning the term would have to a person of ordinary skill in the art in question” at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In the Mylan IPR, we determined the meaning of several claim terms of the ’680 Patent. See Ex. 1011, 15–18. The parties contend that the terms of the ’680 Patent claims should be interpreted in accord with our prior construction. See Pet. 17–18; Prelim. Resp. 19. For the reasons set forth in the Mylan Decision, we agree. See Ex. 1011, 16–18. C.” slip op. at 21

  • Skill levelOther

    “Person of Ordinary Skill in the Art. The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 16–17; Prelim. Resp. 18–19. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormonal-dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 20

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 8,329,680
• Generico, LLC / Flat Line Capital LLC et al. v. Dr. Falk Pharma GmbHAll claims unpatentable
  PTAB · May 19, 2017 · IPR2016-00297 · APJ Elizabeth M Roesel · IPR · Final written decision

  Claims 1 and 16 are unpatentable as obvious over the Sept. 2007 Press Release, Endonurse, and Davis-1985 in view of either Marakhouski or Brunner.

  RulingsFinal written decision

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

    “is an express definition for the term “remission.” In the Specification, the term, “DAI score,” is expressly defined in the following passage: Ulcerative colitis disease activity was assessed using a modified Sutherland Disease Activity Index1 (DAI), which is a sum of four subscores based on stool frequency, rectal bleeding, mucosal appearance on endoscopy, and physician’s rating of disease activity. Each subscore can range from 0 to 3, for a total possible DAI score of 12. Ex. 1001, 17:7–12.4 When the express definitions for “remission” and “DAI score” are read together, the claim 1 phrase “remission is defined as a DAI” slip op. at 9

  • Skill levelSkill level board ownOther

    “The ’688 patent relates to a method for administering granulated mesalamine to treat ulcerative colitis. The claimed method is the result of pharmacokinetic studies and clinical studies conducted by the inventors. Ex. 2036 ¶¶ 7, 10–12, 19, 21 (inventor declaration describing pharmacokinetic and clinical studies); Exs. 2029, 2045, 2048–2050 (reports and protocol for pharmacokinetic and clinical studies). Most of the written description of the ’688 patent relates to these studies. Ex. 1001, 6:27–35, 6:43–7:25, 16:1–45, 17:1–35, 21:17–33:64, Figs. 1–3 (clinical studies); id. at 7:26–31, 14:5–15:67, 16:47–67, 17:38–21:15 (pharmacokinetic, in vitro, and animal studies). According to Dr. Johnson’s testimony, neither of the inventors is a medical doctor, and neither has experience treating patients. Ex. 1067, 16:23–17:8, 22:19–23:3. Co-inventor William Forbes has a doctorate in pharmacy (“Pharm.D.”) and was Vice President of Research and Development for Salix at the relevant time. Ex. 1012, 1; Ex. 1067, 24:14– 25:17. Co-inventor Lorin Johnson5 has a Ph.D. in molecular biology and” slip op. at 12

  • Expert testimonyPetitioner expert creditedDecided for patent owner
  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

  Patent outcomesUS 8,865,688 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,865,688
• Tristar Products, Inc. v. Choon’S Design, LLCNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01883 · APJ Jennifer Meyer Chagnon · IPR · Final written decision

  The Board held claim 3 not shown unpatentable under §102 or §103 over La Croix because its cotter-pin heads could not hold a link in place to form a Brunnian link.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “As instructed by the Federal Circuit, “[e]ven under the broadest reasonable interpretation, [our] construction ‘cannot be divorced from the specification and the record evidence.’” Microsoft v. Proxyconn, 789 F.3d at 6 We note, the language in claim 3 is “the top portion comprises a flared portion for holding a link in place” and not the language from claim 1, argued by Petitioner, namely that the top portion is “for holding the link in a desired orientation.” 1298 (citations omitted). The ’420 patent is titled “Brunnian Link Making Device and Kit.” Ex. 1001, at [54]. The entire written description of the ’420 patent relates to forming Brunnian linked articles, thus suggesting that the “top portion compris[ing] a flared portion,” as claimed, must be capable of holding a link in place—a capability necessary to forming a Brunnian linked article. On that point, Mr. Ng, Patent Owner’s declarant,7 testifies:” slip op. at 16

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

    “Patent Owner’s assertions, as discussed above. Instead, Petitioner argues that “Patent Owner’s entire Response . . . rises or falls on the Board narrowly construing” certain terms, including “the top portion comprises a flared portion for holding a link in place.” Pet. Reply. 1. We have discussed our construction of “the top portion comprises a flared portion for holding a link in place,” above (see supra Section II.C). As discussed, based on the entire record now before us, we agree with Patent Owner that the claimed “the top portion compris[ing] a flared portion for holding a link in place,” requires the top portion of the pin must flare about the circumference of the pin in such a manner as to be capable of holding a link in place for forming a Brunnian link. The arguments in Petitioner’s Reply that La Croix teaches the cotter pins include a “top portion compris[ing] a flared portion for holding a link in place” are premised on its proffered construction (see Pet. Reply 11–12), which we do not adopt for purposes of this Decision. It is Petitioner’s burden to prove unpatentability by a preponderance of the evidence, including proving that the cited reference teaches all elements of the claims, as properly construed. See 35 U.S.C. § 316(e). As the Federal Circuit has noted, [i]n an inter partes review, the burden of persuasion is on the petitioner to prove “unpatentability by a preponderance of the evidence,” and that burden never shifts to the patentee. “Failure to prove the matter as required by the applicable standard means that the party with the burden of persuasion loses on that point— thus, if the fact trier of the issue is left uncertain, the party with the burden loses.” Dynamic Drinkware, 800 F.3d at 1378–79 (citations omitted). Other than arguing that Petitioner disagrees with Patent Owner’s proposed construction, Petitioner does not present evidence to rebut Patent Owner’s assertion that the cotter pins of La Croix are not flared about the circumference of the center of the pin in such a manner as to be capable of holding a link in place for forming a Brunnian link. Based on the evidence of record, and for the reasons discussed, we determine Petitioner has not shown, by a preponderance of the evidence, that La Croix anticipates claim 3.” slip op. at 25

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

    “For the same reasons discussed above with respect to Petitioner’s anticipation challenge to claim 3, we are not persuaded that Petitioner has shown that La Croix teaches or suggests pins having “top portion[s] compris[ing] a flared portion for holding a link in place,” as recited in claim 3. Because we are not persuaded that Petitioner has shown that La Croix discloses or suggests all of the elements of claim 3, we need not reach Patent Owner’s evidence of secondary considerations (see PO Resp. 10–12). Based on the evidence of record, and for the reasons discussed, we determine Petitioner has not shown, by a preponderance of the evidence, that La Croix renders claim 3 obvious. III.” slip op. at 27

  Patent outcomesUS 8,684,420 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,684,420
• 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

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.