• Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentable
  PTAB · Jun 22, 2018 · PGR2017-00008 · APJ Sheridan K Snedden · PGR · Final written decision

  Claims 1–17 are unpatentable under § 112(a) for lack of written description because the claimed dosing regimen is not supported by the specification.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “with regard to claim 17. Nonetheless, we are not persuaded by Petitioner’s contentions. Rather, we find that the ’239 patent contains a sufficient written description of an oral dosage form containing “at least 10% zoledronic acid.” The specification describes a full panoply of zoledronic acid concentrations. Liquid compositions may contain “about 10% (w/v) to about 15% (w/v), about 15% (w/v) to about 20% (w/v), about 20% (w/v) to about 30% (w/v), about 30% (w/v) to about 40% (w/v), or about 40% (w/v) to about 50% (w/v) of zoledronic acid.” Ex. 1003, 10:25–28. Solid dosage forms may contain “at least about 10% (w/w), at least about 20% (w/w) . . .” up to “at least about 80% [w/w]” zoledronic acid. Id. at 10:30–32. Solid dosage forms also are described as containing zoledronic acid in ranges beginning from “about 10% (w/w) to about 30% (w/w), about 10% (w/w) to about 20% (w/w) . . .” all the way up to a range of “about 80% (w/w) to about 90% (w/w).” Id. at 10:32–39. The breadth of zoledronic acid concentration ranges disclosed is more comprehensive than, and therefore distinguishable from, the more limited concentration ranges disclosed in Wertheim (claimed range of “at least 35%” not supported by disclosure of 25% to 60% range disclosed in priority application). In short, we determine that a person of ordinary skill in the art – a medical doctor with experience treating CRPS – would have recognized that the “inventor invented what is claimed” and did not overreach in claiming “at least 10% zoledronic acid” in an orally administered dosage form for treating CRPS. See University of Rochester, 358 F.3d at 928 (Fed. Cir. 2004).” slip op. at 21

  • Expert testimonyOther

    “Unocal or Wertheim where the specification clearly allowed persons of ordinary skill in the art to recognize the claimed invention despite the absence of literal support. In Unocal, the original disclosure explicitly described the effects of altering the variables, explicitly described the claimed endpoints as preferred, or explicitly recited them in an original claim. Moreover, persuasive expert testimony was offered to support the finding that the specification reasonably conveyed to one skilled in the relevant art that the inventor possessed the later claimed invention. Unocal, 208 F.3d at 993, 998–99. In Wertheim, the CCPA held that the specification supported the claimed range of 35–60% where the specification described the range of 25–60% along with specific embodiments of 36% and 50%. 541 F.2d at 264–65. In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed

    “In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16

  Patent outcomesUS 9,283,239 unpatentable
  § 112 disclosure
  Patents in suitUS 9,283,239
• Initiative For Medicines, Access & Knowledge (I-Mak), Inc. v. Gilead Pharmasset LLCInstitution denied
  PTAB · Jun 13, 2018 · IPR2018-00103 · APJ Lora M Green · IPR · Institution

  The Board denied institution for claims 1–19 because the Petition did not show a reasonable likelihood that any challenged claim was anticipated by Klecker or Sommadossi, or obvious over Sommadossi and Klecker.

  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. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of any of the challenged claims. Accordingly, we decline to institute an inter partes review for any challenged claim of the ’572 patent.” slip op. at 2

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

    “reasonable likelihood that claim 1 is anticipated by Klecker. To anticipate a reference must expressly or inherently disclose “within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (2008). Moreover, “anticipation is not proven by ‘multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.’” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1069 (Fed. Cir. 2017) (internal citation omitted). “[A] disclosed genus may anticipate a claimed species when the genus is so small that one of ordinary skill in the art would ‘at once envisage each member of this limited class.’” Wasica Fin. GmbH v. Continental Auto. Sys., Inc., 853 F.3d 1272, 1285 (Fed. Cir. 2017) (quoting AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1379 (Fed. Cir. 2014)). In this case, we agree with Patent Owner that Petitioner is improperly using claim 1 as a roadmap to cherry pick teachings of the Klecker reference to arrive at compounds encompassed by the genus of that claim. For example, we acknowledge that Klecker teaches that a fluorine may be placed below the ring at the 2' position of the sugar ring. Ex. 1005, 19:25‒26. Petitioner does not point us to any teaching of Klecker, however, that teaches a compound that has both a methyl group and a fluorine at the 2' position of the sugar ring, regardless of whether the fluorine is in the up position or the down position. That is, although the broad genus of compounds disclosed by Klecker encompasses such compounds, Petitioner does not point us to any teaching, other than the broad disclosure of the genus, wherein “W, X, Y, [and] Z” may be “H, hydroxy, halogen, alkyl (C1- C6), alkoxy (C1-C6)a label containing moiety or a label” (Ex. 1005, 15:3‒5), that would direct the ordinary artisan to choose X and W such that one of X and W is methyl and the other is fluorine, much less pointing to support of X as fluorine and W as methyl.” slip op. at 11

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Petitioner relies on the Declaration of Dr. Fortunak in asserting that because Klecker teaches the X position may be substituted with fluorine and teaches that W can be an alkyl (C1 – C6), the ordinary artisan would understand from “general knowledge and common sense that methyl is a preferred lower alkyl in that group.” Pet. 34 (citing Ex. 1002 ¶ 92). Dr. Fortunak, however, merely repeats the statement in the Petition without citing any evidentiary support. See Ex. 1002 ¶ 92; see also id. ¶¶ 93‒95 (discussing choosing other substituents in the structure of Klecker). Conclusory statements by an expert “that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). Furthermore, Petitioner’s conclusory statements (Pet. 34‒35) that because C is the first substituent identified for J, and H and OH are the first two substituents identified for Y and Z and, thus, the ordinary artisan would immediately envisage a compound where J is C, Y is H, and Z is OH, do not sufficiently persuade us that the ordinary artisan would immediately envisage their implementation to arrive at compounds that fall within the genus of claim 1.” slip op. at 12

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

    “To the extent that Petitioner (Pet. 51‒52) is invoking inherency in arguing that the express teaching of Sommadossi that R7 may be chloro, 6 Britton et al., U.S. Patent 5,420,266, issued May 30, 1995 (Ex. 1011). bromo and iodo, is also an express teaching that R7 may be fluoro, we disagree that the use of fluoro as the R7 group is inherent in the teachings of Sommadossi. “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999), quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). Even though the ordinary artisan may have understood that fluoro is also a halogen and may be substituted for chloro, bromo, or iodo, the fact remains that Sommadossi taught the use of, inter alia, chloro, bromo, or iodo at the R7 position, specifically, rather than a halogen element, generally. Ex. 1006, 13:24‒27. Petitioner’s argument (Pet. 52) that “Sommadossi taught that R6 could be ‘chloro, bromo, fluoro, [or] iodo,’” is actually counter to Petitioner’s assertions. That is, that statement demonstrates that Sommadossi knew that “fluoro” could be included in the list of halogens. Moreover, Sommadossi defined the term “halo” as “chloro, bromo, iodo, and fluoro.” Ex. 1006, 52:31. Thus, to avoid inadvertently excluding a halogen, Sommadossi could have used the term “halo” in listing the possible substituents for the R7 group, but chose not to do so. Accordingly, we determine that Petitioner has not sufficiently established that Sommadossi anticipates the compounds of claim 1. Because, as discussed above in our analysis of the anticipation ground over Klecker, all of the claims require the compound of that claim, or a particular compound that falls within the genus of claim 1, Petitioner has also not sufficiently demonstrated that any of the challenged claims are anticipated by Sommadossi. Accordingly, we decline to institute trial as to any of the challenged claims on the basis that the claim is anticipated by Sommadossi.” slip op. at 17

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 7,429,572
• Teoxane S.A. v. Allergan, PLC Et Al.Institution denied
  PTAB · Mar 9, 2018 · IPR2017-02002 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of prevailing on any challenged claim.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Taking account of the information presented, we determine that the Petition fails to make out that threshold showing for review. Accordingly, we deny the Petition and decline to institute a trial.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A. The Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art at the time of the invention would have had a B.S. or M.S. in biochemistry, polymer chemistry, medicinal chemistry, pharmaceutical chemistry, or a related field with “several years” of practical experience. Alternatively, according to Petitioner, the ordinary artisan would have had less practical experience but a Ph.D. in one of those fields, or an M.D. in dermatology, plastic surgery, or a specialty related to the clinical use of dermal fillers. Pet. 10 (citing Ex. 1041 ¶¶ 12–13). Patent Owner does not contest that argument in the Preliminary Response. For purposes of this decision, we accept Petitioner’s definition, which, on this record, is consistent with the level of skill reflected in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reveal the level of ordinary skill in the art).” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner

    “Second, a term in a patent preamble is limiting when it “breathes life and meaning into the patent claims.” In re Wertheim, 541 F.2d 257, 269 (CCPA 1976). “Whether to treat a preamble as a limitation is a determination ‘resolved only on review of the entire” patent disclosure “to gain an understanding of what the inventors actually invented and intended to encompass by the claim.’” Catalina Mktg. Int’l. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Corning Glass Works v. Sumitomo Electric U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). Our review of the ’475 patent persuades us that the inventors “actually invented and intended to encompass by” claim 1 a stable composition as defined in the specification. Catalina Mktg. Int’l., 289 F.2d at 808. The inventors disclosed and claimed a “stable” composition containing both HA and lidocaine that overcame the “relative inferior stability properties” of prior art compositions. Ex. 1001, 2:6–32. In that regard, the specification repeatedly refers to the ability of the claimed compositions to remain stable after high-temperature sterilization procedures (such as autoclaving) or shelf-storage storage for prolonged lengths of time. See, e.g., id. at 2:42–49 (contrasting the “enhanced stability” of the claimed compositions “relative to conventional HA-based compositions including” “lidocaine” “when subjected to sterilization techniques such as autoclaving” or “when stored for long periods of time at ambient temperature”);” slip op. at 10

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

    “One final point pertaining to the “stable” limitation requires discussion. The specification makes clear that stability, in the context of the ’475 patent, relates to the “shelf life” of the composition “when stored for a lengthy period of time” prior to injection into a patient, for example, “for a period of time of at least 6 months to a year or more.” Id. at 6:51–53, 13:51; see id. at 2:26–27 (objective of invention is to provide “HA-based injectable compositions which incorporate lidocaine” that are not “prone to” degradation “when placed in storage for any significant amount of time”), 4:42–43, 5:33–38 (composition has “enhanced stability” “when stored at ambient temperature for an extended period of time”), 8:4–5 (the composition of the invention will “remain stable when stored for long periods of time at room temperature”). Accordingly, we determine that the preamble term “stable” (Ex. 1001, 16:40) “breathes life and meaning into” claim 1 and, therefore, is limiting. In re Wertheim, 541 F.2d at 269. We adopt for purposes of this decision the following definition of “stable,” which is advanced by Petitioner: soft tissue filler that is free of viable microorganisms as determined by a sterility test recognized by a regulatory authority, the filler can be sterilized by any method known in the art, and is resistant to degradation such that the composition maintains one or more of the following aspects: transparent appearance, pH, extrusion force and/or rheological characteristics, hyaluronic acid (HA) concentration, sterility, osmolarity, and lidocaine concentration, after being effectively sterilized by autoclaving and subsequently stored at a temperature of at least about 25° C for at least about two months. Pet. 11. That construction is not opposed by Patent Owner at this stage of the proceeding (Prelim. Resp. 3–4) and is substantially consistent with an express definition set forth in the specification. Ex. 1001, 5:17–20.” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,450,475
• Teoxane S.A. v. Allergan, PLC Et Al.Institution denied
  PTAB · Mar 9, 2018 · IPR2017-01906 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of prevailing on any challenged claim.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Taking account of the information presented, we determine that the Petition fails to make out that threshold showing for review. Accordingly, we deny the Petition and decline to institute a trial.” slip op. at 2

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “printed publication” that was “sufficiently accessible to the public interested in the art” before the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). The touchstone of public accessibility is whether an ordinary artisan “exercising reasonable diligence” would have been able to locate the document prior to the critical date. SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008). Petitioner availed itself of two opportunities to make out that showing, but has not done so adequately. See Pet. 4, 14; Reply 1–5. slip op. at 11

  • Strike new argumentNew argument disregardedDecided for patent owner

    “favored providing Petitioner an opportunity to respond to the evidence, presented in the Preliminary Response, which undercuts the Petition’s bare attorney argument that the Elevess Summary qualifies as a printed publication. Paper 11 (providing Petitioner an opportunity to file a Reply and Patent Owner to file a Sur- Reply on that issue). In the Reply, however, Petitioner abandons the evidence presented in the Petition, does not address the evidence presented in the Preliminary Response, and instead advances an entirely new theory of public accessibility. Reply 1–5 (citing Exs. 1067, 1068, 1069, and 1070). Petitioner’s Reply to the Preliminary Response is not the proper place to raise such information, which should have been presented in the Petition. Because the argument and evidence presented in the Reply exceeds the scope of a proper reply, we have discretion to exclude it. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the corresponding opposition or patent owner response.”).” slip op. at 12

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

    “in claim 1 requiring a composition “wherein the lidocaine is freely released in vivo” (after injection in a patient). Ex. 1001 19:31. On that point, we agree with Patent Owner that the Petition fails to address adequately how the presence of HI in Hunter’s composition would affect the free release of lidocaine from the HA gel in vivo. See Pet. 20–21; Prelim. Resp. 14–15 (pointing out that the Petition includes no showing that the lidocaine in Hunter’s composition “would necessarily be ‘freely released’ in vivo” where Hunter discloses “very different compositions” that include both “hyaluronic acid and an inhibitory compound” that “can inhibit the activity of hyaluronidase” (quoting Ex. 1004, 11)).” slip op. at 17

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,357,795
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Feb 8, 2018 · IPR2016-01412 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 1–13 and 16–19 are unpatentable as obvious over Palermo, Joshi, and Handbook, and over Oshlack, Joshi, Handbook, and Doyon.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 15 (citing Ex.1007 ¶¶ 31– 34). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 24 (citing Ex. 2001 ¶¶ 74–75). We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “We find Petitioner’s proposed construction to be more persuasive based on the ’376 patent specification. In particular, the specification defines “unsuitable for injection” “to mean that one would have substantial difficulty injecting the dosage form (e.g., due to pain upon administration or difficulty pushing the dosage form through a syringe) due to the viscosity imparted on the dosage form, thereby reducing the potential for abuse of the opioid analgesic from the dosage form.” Ex. 1001, 3:15–20. Additionally, in an example concerning the formation of a gel at different concentrations, the specification characterizes certain solutions as “THICK (10 cP to 60 cP): Although a syringe can be filled with this solution, it was hard to do.” Id. at 32:8–24, Table 3. Thus, the specification teaches that a viscosity of at least 10 cP is difficult to pull into a syringe or administer parenterally (via injection). Patent Owner does not address these teachings of the specification. We, therefore, determine that the broadest reasonable interpretation of “unsuitable for parenteral administration” and “unsuitable to pull into an insulin syringe” encompasses a gelling agent that imparts a viscosity of at least 10 cP.” slip op. at 10

  • PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner

    “articulated a four-factor test in determining whether collateral estoppel attaches: “(1) the identity of the issues in a prior proceeding; (2) the issues were actually litigated; (3) the determination of the issues was necessary to the resulting judgment; and (4) the party defending against preclusion had a full and fair opportunity to litigate the issues.” Levi Strauss & Co. v. Abercrombie & Fitch Trading Co., 719 F.3d 1367, 1371 (Fed. Cir. 2013). Collateral estoppel can attach in proceedings before the Office for identical issues that were addressed with respect to a different patent during prior district court litigation. See In re Arunachalam, No. 2016-1607, 2017 WL 4387224, at *2–4 (Fed. Cir. Oct. 3, 2017) (“In light of Dr. Arunachalam’s previous opportunity to litigate the validity of the asserted claims of the ’500 Patent, which contain the [same] terms . . . , we see no reason to allow her to appeal the patentability of the challenged claims of the ’556 Patent, which also contain the same critical terms.”). All four factors for collateral estoppel are met here. With regard to the first factor, the issue of Joshi’s status as prior art is identical for both proceedings. The ’376 patent is part of the same chain of continuity as the ’888 patent, and both patents share the same specification and claim priority to the same non-provisional application filed August 6, 2002 and provisional application filed August 6, 2001. As such, to the extent Joshi qualifies as prior art to the ’888 patent, it would also qualify as prior art to the ’376 patent.” slip op. at 16

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateWritten description inadequateNot shown unpatentable

    “Although the statements above encompass “mixtures” of HPMC and PEO among a myriad of other possibilities for the gelling agent, we find no basis to conclude that the inventors of the ’376 patent were in possession of the specifically claimed formulation from such a broad disclosure.11 The 10 The April 25th draft application is heavily redacted and we thus cannot discern what other materials were specifically contemplated as “thickening agents” by that time. See Ex. 2091, 5. However, given the nature and amount of the redactions and Patent Owner’s assertion that the draft application ultimately led to the filing of the ’534 provisional with the broad disclosure set forth above, we find it reasonable to conclude that additional materials were included in the draft application. Moreover, the draft application was forwarded as part of an email from Patent Owner’s attorney, which “[e]nclosed the latest draft of the tamper resistant application.” Ex. 2091. As such, there is no evidence to suggest that the list of thickening agents included as part of the draft application originated from the inventors as opposed to patent counsel. 11 We recognize that the same broad disclosure with a “laundry list” of possible gelling agents is found in the specification of the ’376 patent. See Federal Circuit has held that such “laundry list” disclosures are insufficient to satisfy the written description requirement when there is no further guidance (“blazemarks”) provided about which species or combination of species included as part of the list may be selected to arrive at the claimed invention. See Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Not having specifically named or mentioned the combination in any manner, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” In re Ruschig, 379 F.2d 990, 995 (CCPA 1967); see also Los Angeles Biomedical Research Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“To satisfy the written description requirement, the disclosure in each application must ‘reasonably convey[ ]’ to those skilled in the art that as of the claimed priority date the inventor was in possession of the later claimed subject matter.”) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)). Other evidence of record further supports our conclusion that the inventors of the ’376 patent had not conceived of or reduced to practice the claimed formulation prior to Joshi’s August 30, 2001 filing date. In his Declaration, inventor Benjamin Oshlack attests that Patent Owner’s laboratory scientists focused on “testing the syringeability of various concentration solutions of pectin, sodium alginate, and sodium acrylate, as well as combinations of pectin and sodium alginate” between January 4 and Ex. 1001, 6:46–62. We, however, do not address the issue of written description support for any of the subsequently filed applications. 17, 2001. Ex. 2081 ¶ 22. Additionally, Mr. Oshlack attests that the scientists had evaluated “xanthan gum, carrageenan, and locust bean gum (and combinations thereof) as gelling agents, between April 5 and 12, 2001.” Id. ¶ 23. None of the laboratory notebook excerpts proffered by Patent Owner mention a combination of HPMC and PEO as gelling agents to be used in an oxycodone formulation. Exs. 2087–2090. Consistent with the testing actually done, the working examples set forth in the ’534 provisional (as well as in the ’376 patent) focus on xantham gum, pectin, microcrystalline cellulose, and hydroxyethlcellulose as the gelling agents. See Ex. 1026, 44– 49 (Examples 1–5). We find, therefore, that the inventors did not particularly consider either PEO or HPMC, let alone both PEO and HPMC in combination, when evaluating possible gelling agents for an abuse-deterrent formulation of oxycodone. Accordingly, because we find that the ’376 patent is not entitled to a filing date earlier than August 6, 2002, we further determine that Joshi qualifies as § 102(e) prior art as of that date. Having determined that Joshi qualifies as prior art, we turn to the merits of Petitioner’s patentability challenges.” slip op. at 21

  Patent outcomesUS 9,034,376 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosure
  Patents in suitUS 9,034,376
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01413 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 1–13 and 16–19 are unpatentable as obvious over Royce, McGinity, Hoffmeister, Joshi, and PDR.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer 1 Royce, U.S. Patent 5,273,758, issued Dec. 28, 1993 (Ex. 1022) (“Royce”). 2 McGinity et al, WO 97/49384, published Dec. 31, 1997 (Ex. 1024) (“McGinity”). 3 Hoffmeister et al., U.S. Patent 4,070,494, issued Jan. 24, 1978 (Ex. 1010) (“Hoffmeister”). 4 Joshi et al., Pub. No. US 2002/0187192 A1, published Dec. 12, 2002 (Ex. 1014) (“Joshi”). 5 OxyContin entry in Physicians’ Desk Reference, 2569–74 (53d ed., 1999) (Ex. 1016)(“PDR”). chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 16 (citing Ex. 1007 ¶¶ 31– 34). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 27. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill of art in this proceeding is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “We find Petitioner’s proposed construction to be more persuasive based on the ’376 patent specification. In particular, the specification defines “unsuitable for injection” “to mean that one would have substantial difficulty injecting the dosage form (e.g., due to pain upon administration or difficulty pushing the dosage form through a syringe) due to the viscosity imparted on the dosage form, thereby reducing the potential for abuse of the opioid analgesic from the dosage form.” Id. at 3:15–20. Additionally, in an example concerning the formation of a gel at different concentrations, the specification characterizes certain solutions as “THICK (10 cP to 60 cP): Although a syringe can be filled with this solution, it was hard to do.” Id. at 32:8–24, Table 3. Thus, the specification teaches that a viscosity of at least 10cp is difficult to pull into a syringe or administer parenterally (via injection). Patent Owner does not address these teachings of the specification. We, therefore, determine that the broadest reasonable interpretation of “unsuitable for parenteral administration” and “unsuitable to pull into an insulin syringe” encompasses a gelling agent that imparts a viscosity of at least 10 cp.” slip op. at 9

  • PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner

    “Under the doctrine of issue preclusion, also called collateral estoppel, a judgment on the merits in a first suit precludes relitigation in a second [proceeding] of issues actually litigated and determined in the first suit.” In re Freeman, 30 F.3d 1459, 1465 (Fed. Cir. 1994) (citing Lawlor v. National Screen Serv. Corp., 349 U.S. 322, 326 (1955)). The Federal Circuit has articulated a four-factor test in determining whether collateral estoppel attaches: “(1) the identity of the issues in a prior proceeding; (2) the issues were actually litigated; (3) the determination of the issues was necessary to the resulting judgment; and (4) the party defending against preclusion had a full and fair opportunity to litigate the issues.” Levi Strauss & Co. v. Abercrombie & Fitch Trading Co., 719 F.3d 1367, 1371 (Fed. Cir. 2013). Collateral estoppel can attach in proceedings before the Office for identical issues that were addressed with respect to a different patent during prior slip op. at 16

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner

    “Although the statements above encompass “mixtures” of HPMC and PEO among a myriad of other possibilities for the gelling agent, we find no basis to conclude that the inventors of the ’376 patent were in possession of the specifically claimed formulation from such a broad disclosure.10 The Federal Circuit has held that such “laundry list” disclosures are insufficient to satisfy the written description requirement when there is no further guidance (“blazemarks”) provided about which species or combination of species included as part of the list may be selected to arrive at the claimed 9 The April 25th draft application is heavily redacted and we thus cannot discern what other materials were specifically contemplated as “thickening” agents by that time. See Ex. 2091, 5. Given the nature and amount of the redactions and Patent Owner’s assertion that the draft application ultimately led to the filing of the ’534 provisional with the broad disclosure set forth above, we find it reasonable to conclude that additional materials were included in the draft application. Moreover, the draft application was forwarded as part of an email from Patent Owner’s attorney, which “[e]nclosed the latest draft of the tamper resistant application.” Ex. 2091. As such, there is no evidence to suggest that the list of thickening agents included as part of the draft application originated from the inventors as opposed to patent counsel. 10 We recognize that the same broad disclosure with a “laundry list” of possible gelling agents is found in the specification of the ’376 patent. See Ex. 1001, 6:46–62. We, however, do not address the issue of written description support for any of the subsequently filed applications. invention. See Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Not having specifically named or mentioned the combination in any manner, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” In re Ruschig, 379 F.2d 990, 995 (CCPA 1967); see also Los Angeles Biomedical Research Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“To satisfy the written description requirement, the disclosure in each application must ‘reasonably convey[ ]’ to those skilled in the art that as of the claimed priority date the inventor was in possession of the later claimed subject matter.”) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)). Other evidence of record further supports our conclusion that the inventors of the ’376 patent had not conceived of or reduced to practice the claimed formulation prior to Joshi’s August 30, 2001, filing date. In his declaration, inventor Benjamin Oshlack attests that Patent Owner’s laboratory scientists focused on “testing the syringeability of various concentration solutions of pectin, sodium alginate, and sodium acrylate, as well as combinations of pectin and sodium alginate” between January 4 and 17, 2001. Ex. 2081 ¶ 22. Additionally, Mr. Oshlack attests that the scientists had evaluated “xanthan gum, carrageenan, and locust bean gum (and combinations thereof) as gelling agents, between April 5 and 12, 2001.” Id. ¶ 23. None of the laboratory notebook excerpts proffered by Patent Owner mention a combination of HPMC and PEO as gelling agents to be used in an oxycodone formulation. Exs. 2087–2090. Consistent with the testing actually done, the working examples set forth in the ’534 provisional (as well as in the ’376 patent) focus on xantham gum, pectin, microcrystalline cellulose, and hydroxyethlcellulose as the gelling agents. See Ex. 1026, 44– 49 (Examples 1–5). We find, therefore, that the inventors did not particularly consider either PEO or HPMC, let alone both PEO and HPMC in combination, when evaluating possible gelling agents for an abuse-deterrent formulation of oxycodone. Accordingly, because we find that the ’376 patent is not entitled to a” slip op. at 22

  Patent outcomesUS 9,034,376 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 9,034,376
• Taro Pharmaceuticals U.S.A., Inc. v. Apotex Technologies, Inc.Rehearing denied
  PTAB · Jan 11, 2018 · IPR2017-01446 · APJ Jeffrey N Fredman · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in instituting review because the record showed a reasonable likelihood of inherent anticipation.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “ANALYSIS When rehearing a decision on institution, the Board will review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The applicable standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. Patent Owner “submits that the evidence of record fails to show that” slip op. at 2

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

    “THRESHOLD – The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 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. As also noted in the decision on institution, we have considered both the Petition and Patent Owner Preliminary Response, and determined that the information presented in the Petition demonstrates that there is a reasonable likelihood that Petitioner would prevail with respect to the challenged claims. Dec. 2. Therefore, we applied the correct threshold standard for instituting the inter partes review.” slip op. at 9

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundOther

    “We agree with Patent Owner on the legal standard for inherency. As we acknowledged in our Decision, “[i]nherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).” Dec. 14. However, we remain persuaded at this stage of the proceeding on the current factual record based on Hoffbrand 1998 and the Mehta Declaration, that Petitioner established a “reasonable likelihood” that Hoffbrand 1998 necessarily disclosed treatment of patients with “an iron overload condition of the heart” with a therapeutically effective amount of deferiprone. See Dec. 16–20; 35 U.S.C. § 314(a). Patent Owner does not identify a definition of the phrase “iron overload condition of the heart” in the ’328 patent Specification that distinguishes the claimed patient population from Hoffbrand’s disclosure of “10 patients [that] had a liver iron content above 15.0 mg/g dry weight, ie, falling within the range that has been associated with cardiac disease.” Ex. 1007, 297. The reasonable understanding of Hoffbrand’s teaching of this association between liver iron content and cardiac disease is that all ten patients with the elevated iron levels also necessarily fell into the spectrum of having “an iron overload condition of the heart.” Indeed, Patent Owner’s Declarants do not rebut Hoffbrand’s teaching that liver iron content above 15.0 mg/g identifies patients with cardiac disease, and, therefore, with “an iron overload condition of the heart.” Dr. Coates simply notes that Hoffbrand 1998 reports five treated “patients suffered fatal complications. . . . Four of the five reported fatalities resulted from congestive heart failure.” Ex. 2001 ¶ 37. Cf. Pennell Decl. Ex. 2003 ¶ 37. That statement supports the position that Hoffbrand 1998 treated patients who inherently had an ultimately fatal “iron overload condition of the heart” with 75 mg of deferiprone, acknowledged by claim 15 of the ’328 patent as a therapeutically effective amount. Ex. 1007, 295; Ex. 1001, 28:33–37. We recognize that Dr. Pennell stated that “a patient with a liver iron content above 15 mg/g dry weight is at risk of developing cardiac disease not that such liver iron content definitely establishes cardiac disease.” Ex. 2003 ¶¶ 50–51, citing Exhibits 2007, 2015, and 2016. The Exhibits cited by Dr. Pennell do not identify evidence showing a single patient with a liver iron content that exceeds 15.0 mg/g but failed to display an “iron overload condition of the heart.” See Ex. 2003 ¶ 51. Exhibit 2007 states “while whole liver iron levels >15 mg/g dry weight . . . have been shown to predict patients at highest risk of cardiac death, it is not known how these variables relate to cardiac iron deposition.” Ex. 2007, 1. No specific patient data is provided in Exhibit 2007 comparing liver iron levels of particular patients with “iron overload.” See id. Similarly, Exhibits 2015 and 2016 also do not identify any patients with elevated liver iron content >15 mg/g dry weight with normal cardiac iron levels. Therefore, the evidence currently of record in Hoffbrand 1998,” slip op. at 3

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Regarding the second argument, Dr. Mehta relied upon specific facts within the Olivieri Abstract 1995 itself to support the conclusion that “lower TRT values indicate cardiac disease due to iron overload. Ex. 1010 (Olivieri Abstract 1995).” Ex. 1002 ¶ 75. In particular, Olivieri Abstract 1995 states “MRI demonstrates changes consistent with reduction in cardiac iron in L1 [deferiprone]-treated pts, in who baseline T2 relaxation time (TRT of 23.9±6.4 msec (normal >32) has increased to 32.4±9.3msec.” Ex. 1010. Olivieri Abstract 1995’s identification of the value of “32” as normal for TRT levels with lower values such as “23.9±6.4” as associated with elevated cardiac iron levels that require treatment with deferiprone, provides factual support for Dr. Mehta’s conclusion that patients with these lower TRT values inherently have “an iron overload condition of the heart.” See Ex. 1002 ¶ 75.” slip op. at 6

  § 102 anticipation
  Patents in suitUS 7,049,328
• CSL Behring GmbH / CSL Behring LLC v. Shire Viropharma Inc.Institution denied
  PTAB · Dec 7, 2017 · IPR2017-01512 · APJ Lora M Green · IPR · Institution

  Institution was denied for claims 1-18: Schranz was not shown to be prior art, and the Jiang ground was denied under §325(d) because the same art and arguments were previously presented.

  RulingsInstitution decision

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

    “may request to cancel . . . claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” Before considering the ground before us based on Schranz, we must address whether Petitioner has provided a sufficient threshold showing that Schranz constitutes prior art under 35 U.S.C. § 102—a legal question based on underlying factual determinations. Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568” slip op. at 6

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “As was the case in Dep’t of Justice, the use of a joint declaration “invites innumerable practical difficulties in cross-examining the witnesses, in assessing the reliability of the statements made, and in evaluating the weight to be accorded to the opinions expressed.” Dep’t of Justice 10. For example, Dr. Machnig and Mr. Waldhauser declare in “our recollection.” Ex. 1013-A ¶ 4. It is unclear how two different declarants can have the same “recollection.” In addition, the declarants state that “[h]andouts of the poster . . . [were] picked up by us.” Id. ¶ 5. It is unclear from the Joint Declaration, however, if both declarants were together when the hand-out was picked-up, or if each declarant picked up the handout at separate times. We, therefore, afford the Joint Declaration of Dr. Machnig and Mr. Waldhauser little weight. See Dep’t of Justice 11. As it is the primary evidence on which Petitioner relies to demonstrate that Schranz is prior art, we determine that Petitioner has not made a threshold showing that Schranz is prior art to the ’111 patent. As Petitioner has not sufficiently demonstrated that Schranz is prior art to the ’111 patent, we determine that the Petition does not demonstrate a reasonable likelihood that challenged claims 1‒18 are rendered obvious by the combination of Schranz (as evidenced by Cinryze Label and Bock), Gatlin, Pharming, and Levi.” slip op. at 9

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

    “In the instant proceeding, we agree with Patent Owner that Petitioner is essentially making the same arguments as to obviousness over Jiang that the Examiner already considered. The prosecution history demonstrates that the Examiner considered many of the same issues with respect to the Schranz Declaration as Petitioner is arguing here. Although the Examiner noted in allowing the claims that Applicant Shire had established the secondary consideration of long-felt need and failure of others, the Examiner also stated that the art did not suggest the claimed dosage. We determine, therefore, that the Examiner did address the Schranz Declaration, and the Examiner’s concerns are similar to those raised by Petitioner in the instant proceeding. That is, as the Examiner stated: The Examiner has considered the arguments found in Dr. Schranz’s declaration concerning difficulty in higher concentration formulation. However, Dr. Schranz’s declaration provides little more than an assertion that it is difficult to reach such a concentration formulation, as opposed to actual evidence establishing that this (1) was a recognized problem in the art and (2) was generally not achievable via other means. Ex. 1001-B, 3041. Thus, the Examiner did acknowledge the lack of supporting evidence in the Schranz Declaration demonstrating that it was difficult to reach the claimed concentration.” slip op. at 13

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “As was the case in Dep’t of Justice, the use of a joint declaration “invites innumerable practical difficulties in cross-examining the witnesses, in assessing the reliability of the statements made, and in evaluating the weight to be accorded to the opinions expressed.” Dep’t of Justice 10. For example, Dr. Machnig and Mr. Waldhauser declare in “our recollection.” Ex. 1013-A ¶ 4. It is unclear how two different declarants can have the same “recollection.” In addition, the declarants state that “[h]andouts of the poster . . . [were] picked up by us.” Id. ¶ 5. It is unclear from the Joint Declaration, however, if both declarants were together when the hand-out was picked-up, or if each declarant picked up the handout at separate times. We, therefore, afford the Joint Declaration of Dr. Machnig and Mr. Waldhauser little weight. See Dep’t of Justice 11. As it is the primary evidence on which Petitioner relies to demonstrate that Schranz is prior art, we determine that Petitioner has not made a threshold showing that Schranz is prior art to the ’111 patent. As Petitioner has not sufficiently demonstrated that Schranz is prior art to the ’111 patent, we determine that the Petition does not demonstrate a reasonable likelihood that challenged claims 1‒18 are rendered obvious by the combination of Schranz (as evidenced by Cinryze Label and Bock), Gatlin, Pharming, and Levi.” slip op. at 9

  § 102 anticipationDiscretionary denial
  Patents in suitUS 9,616,111
• L’Oréal USA, Inc. v. Liqwd, Inc.Institution denied
  PTAB · Jul 19, 2017 · PGR2017-00011 · APJ Christopher M Kaiser · PGR · Institution

  The Board denied institution of PGR on claims 1–10 because Petitioner did not show that any claim was more likely than not unpatentable under § 112.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard for instituting a post-grant review is set forth in 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless the Director determines . . . it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner

    “Moreover, “[a]pplicants can define . . . claim scope during prosecution,” just as they can in a patent specification. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1343 (Fed. Cir. 2015). Here, during prosecution of the ’419 patent, the applicant stated that “[t]he term ‘hair coloring agent’ refers to a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” Ex. 1005, 7. To define specific terms used to describe an invention, the applicant need only set out the definition “with reasonable clarity, deliberateness, and precision,” “so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). On the present record, the definition of the term “hair coloring agent” set out in the prosecution history of the ’419 patent is sufficiently clear, deliberate, and precise to give a person of ordinary skill in the art notice that the term is used in the ’419 patent in a manner that does not include substances other than “colorant[s] or pigment[s] that [are] customarily used in hair care products,” even if those other substances might be described as “hair coloring agents” outside the context of the ’419 patent. Ex. 1005, 7. Accordingly, we should give effect to that definition. Because Patent Owner’s proposed construction of “wherein the mixture does not contain a hair coloring agent” gives effect to the prosecution history’s definition of “hair coloring agent,” we adopt Patent Owner’s proposed construction for purposes of the present decision. Thus, on the present record, and for purposes of the present decision, we construe “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.”” slip op. at 6

  • Disclosure Requirements (§112) › Definiteness (Nautilus)Not shown unpatentable

    “to determine the scope of the claims. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown that it is more likely than not that claims 1–10 of the ’419 patent are indefinite.” slip op. at 10

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “wherein the mixture does not contain a hair coloring agent.” Pet. 36–39; Prelim. Resp. 39–40. If “a hair coloring agent” encompasses bleaching agents, then the claims all require a bleaching formulation and simultaneously exclude a bleaching agent, a scope that Petitioner argues is not described in the specification of the ’419 patent. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown it is more likely than not that claims 1–10 of the ’419 patent lack written description support. slip op. at 12

  Claim construction§ 112 disclosure
  Patents in suitUS 9,498,419
• Steadymed Ltd. v. United Therapeutics CorporationAll claims unpatentable
  PTAB · Mar 31, 2017 · IPR2016-00006 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1–22 are unpatentable under § 102(b) and § 103(a), based on the Board’s anticipation and obviousness grounds.

  RulingsFinal written decision

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

    “proposed construction (PO Resp. 17). Indeed, if any conclusion can be drawn from the specification excerpts highlighted by UTC, it is that the claim term “product” is defined solely by the recited claim limitations. See Ex. 1001, 5:45–46 (referring to the purportedly improved impurity of the “product of the process according to the present invention.”).” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “2. Discussion Each of the challenged claims, including independent claims 1 and 9,” slip op. at 24

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

    “below, we are persuaded by SteadyMed’s showing that an ordinarily skilled artisan, at the time of invention of the ’393 patent, would have had reason to combine, and a reasonable expectation of success in combining, Moriarty and Phares. “[T]he skilled artisan need not be motivated to combine [the prior art] for the same reason contemplated by [the inventor].” In re Kahn, 441 F.3d 977, 990 (Fed. Cir. 2006). In this regard, we note that in addition to teaching that intermediate purification is unnecessary to the production of treprostinil diethanolamine salt by the disclosed process (Ex. 1005, 40–42), Phares explicitly describes the Moriarty process in disclosing the production of (-)-treprostinil, the enantiomer of (+)-treprostinil (id. at 42). Ex. 1009 ¶¶ 50, 77–78. Accordingly, we are persuaded that an ordinarily skilled artisan would have modified the process of Moriarty to incorporate the step of adding and dissolving diethanolamine to treprostinil as taught by Phares (Ex. 1005, 24) to eliminate the requirement for intermediate purification, thus, improving synthetic efficiency and reducing cost.” slip op. at 47

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

    “minimize all impurities in all pharmaceuticals to the extent possible, such a general agency preference for improved purity is insufficient to establish a long-felt but unmet need for improved treprostinil, in particular. See Tex. Instruments v. Int’l Trade Comm’n, 988 F.2d 1165, 1178 (Fed. Cir. 1993) (“[L]ong-felt need is analyzed as of the date of an articulated identified problem and evidence of efforts to solve that problem.”). Indeed, adherence to UTC’s position would dictate a conclusion of nonobvious for any pharmaceutical product exhibiting any improvement in purity over prior art versions of that same product.” slip op. at 61

  Patent outcomesUS 8,497,393 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,497,393

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.