• L’Oréal USA, Inc. v. Liqwd, Inc.Rehearing denied
  PTAB · Oct 18, 2018 · PGR2018-00024 · APJ Christopher M Kaiser · PGR · Rehearing

  The Board denied rehearing, leaving in place its denial of institution because Petitioner did not show an abuse of discretion in construing “bleach powder” or assessing written-description support.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). We “review [our] decision for an abuse of discretion.” Id. § 42.71(c). In addition, we may not consider an argument made in a request for rehearing unless the request “specifically identif[ies] . . . the place where [that argument] was previously addressed in a motion, an opposition, or a reply.” Id. § 42.71(d). After considering the Request for Rehearing, we determine that Petitioner has not demonstrated that we abused our discretion in denying institution. Accordingly, we deny the Request for Rehearing. slip op. at 2

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

    “reconsider the issue of our construction of “bleach powder.” The parties agree that the specification of the ’954 patent does not contain an express definition of “bleach powder,” so we are required to give the term its “ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure.” Translogic, 504 F.3d at 1257; see Pet. 27–28 (arguing that, “[a]bsent any . . . clear intent, the BRI must be consistent with the interpretation that those skilled in the art would reach,” then offering no particular construction of “bleach powder”); Prelim. Resp. 29–30 (“A person of ordinary skill in the art would have understood that bleach powder combines persulfates with alkalinizing compounds . . . in a fine dry particulate form.” (citing only sources outside the ’954 patent)). In arguments that we may consider, the parties draw our attention to six sources of evidence about the ordinary understanding in the art of “bleach powder.” Req. 2–5 (citing Ex. 1039, 48:9–49:9); Prelim. Resp. 29– 30 (citing Ex. 1002, 15:45–65; Ex. 1011, 17; Ex. 2005, 6; Ex. 2007, 3; Ex. 2012 ¶¶ 34–36). There is evidence that supports Patent Owner’s view that the ordinary meaning of “bleach powder” is a powder that contains an alkalizing agent in addition to persulfates, as opposed to merely a persulfate powder. A textbook called “Hair Preparations” by Thomas Clausen and others states that, at least in paste bleaches, “a bleach powder” is used that “consists of a peroxodisulfate, an alkalinizing agent,” and other ingredients. Ex. 1011, 17. In the context of cream and gel bleaches, this reference teaches that “[p]eroxosulfate . . . can be added as a bleaching powder” but is silent about whether the “bleaching powder” contains any additional ingredients. Id. In a book chapter on “Hair Coloring” by Keith C. Brown, a “bleach booster” powder is discussed that “is usually a mixture of ammonium and potassium persulfates” and that has “metasilicates mixed in with the persulfates” to provide “[a]lkaline pH.” Ex. 2005, 6. Against this evidence is the testimony of Dr. Borish that “powder lighteners” or “bleach powders” include “persulfate salts.” Ex. 1039, 48:9–49:9. But Dr. Borish does not state affirmatively that the persulfate salt is all that is required for a powder to be a bleach powder, only that a persulfate salt is a necessary component of a bleach powder. Id. Accordingly, his testimony does not outweigh the evidence that, to a person of ordinary skill in the art, a bleach powder contains both a persulfate salt and an alkalizing agent. We are not persuaded, therefore, that we abused our discretion by construing “bleach powder” to require both of those components.” slip op. at 6

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

    “After considering the Request for Rehearing, we determine that Petitioner has not demonstrated that we abused our discretion in denying institution. Accordingly, we deny the Request for Rehearing.” slip op. at 2

  Claim construction
  Patents in suitUS 9,668,954
• Apotex Inc. / Apotex Corp. v. Celgene CorporationInstitution denied
  PTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution

  The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.

  RulingsInstitution decision

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

    “As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24

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

    “As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31

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

    “A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached

    “support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
  Patents in suitUS 8,741,929
• Bioeq IP AG v. Genentech, Inc.Institution denied
  PTAB · Feb 22, 2017 · IPR2016-01608 · APJ Erica A Franklin · IPR · Institution

  The Board denied institution because Petitioner failed to show a reasonable likelihood that any challenged claim was unpatentable over Seeger alone or with the additional references.

  RulingsInstitution decision

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

    “Therefore, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing that Seeger anticipates claims 1, 3–4, 6, 9, 15–16, 20–22, 24–25, 27–28, 30, 33, and 39. Consequently, we decline to institute an inter partes review of claims 1, 3–4, 6, 9, 15–16, 20–22, 24–25, 27–28, 30, 33, and 39 based on this ground. C.” slip op. at 13

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

    “We agree with Patent Owner that the Specification provides an explicit definition for the claim phrase “reducing the metabolic rate.” The Specification states, “[a]s used herein, ‘reducing metabolic rate’ or ‘shifting down metabolic rate’ means altering the host cell culture such that the host” slip op. at 5

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

    “persuaded that Petitioner has not established that Seeger discloses reducing the metabolic rate of the cultured recombinant host cells at the time of induction of polypeptide expression, as required by the challenged claims, for the reasons discussed by Patent Owner. In particular, Petitioner relies upon the disclosure of the ’602 patent describing reducing metabolic rate in cells already in a reduced growth state by reducing the rates of oxygen uptake and the corresponding rates of uptake of a carbon/energy source. Pet. 32–36 (citing Ex. 1001, 4:15–18). However, Petitioner has not addressed adequately how Seeger’s method of inducing expression by increasing temperature from 30 to 42○C may have affected the metabolic rate. Id. at 32–36.” slip op. at 12

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

    “dependent claims. Pet. 27. Petitioner relies upon Seeger alone as disclosing the elements of the independent claims from which those challenged claims depend. Id. at 43–57. Indeed, Petitioner does not address the elements recited in the independent claims in any of the obviousness grounds. Id. To relied upon only to address additional elements of dependent claims, and are not asserted to cure any deficiencies of Seeger with respect to elements of the independent claims. Id. at 46–58. Therefore we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing in showing the unpatentability of dependent claims 7–8 and 31–32 over Seeger, dependent claims 10, 12, 23, 34, and 36 over Seeger and Makrides, or dependent claims 11, 13–14, 18, 35, and 37–38 over Seeger and Cabilly, under 35 U.S.C. § 103(a), for the same reasons discussed regarding the independent claims from which they depend. Consequently, we decline to institute an inter partes review of claims 7–8, 10–14, 18, 23, 31–32, and 34–38 based on the respective ground challenging those claims.” slip op. at 13

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 6,716,602
• Merial, Inc. v. Sergeant’S Pet Care Products, Inc.Institution denied
  PTAB · Sep 29, 2016 · IPR2016-00798 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 1–22 were unpatentable over the asserted obviousness grounds.

  RulingsInstitution decision

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

    “we find that Petitioner has failed to show a reasonable likelihood of success that any of the challenged claims are unpatentable. The key limitation missing from any teaching or suggestion of the combination is “3% to 16% (w/w) cyphenothrin” (or any narrower range therein) combined with fipronil. Sirinyan provides a formulation using fipronil and cyphenothrin, but expressly states that cyphenothrin should be used in a concentration range of from 30 to 60% by weight, which is well outside of any of the claimed ranges for cyphenothrin in the challenged claims. As Patent Owner points out, a lower range within the claimed range is called out for other α- cyanopyrethroids with the possible use of a synergist (that is not required in the challenged claims), but not for cyphenothrin. Prelim. Resp. 7–8, 21, 29– 32. We agree with Patent Owner that Petitioner has failed to show why one of ordinary skill in the art would ignore the express teaching of Sirinyan and lower the concentration of cyphenothrin to a claimed range in a formulation with fipronil. Garden does not provide any such impetus. As Patent Owner states, Garden describes the activity of cypermethrin and alphacypermethrin (two particular species of the α-cyanopyrethroid genus) without fipronil and without additionally providing any specific teaching with respect to cyphenothrin except to include it in a listing as an α-cyanopyrethroid. Prelim. Resp. 8 (citing Ex. 1006, Examples 1-15); Ex. 1006, 2:15–33 (stating preferred compounds include cyphenothrin). The listing of cyphenothrin as one of a list of preferred pyrethroids, without more, would not suggest to one of skill in the art that a lower amount of cyphenothrin should be used in a formulation with fipronil.” slip op. at 11

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

    “Sirinyan provides a formulation using fipronil and cyphenothrin, but expressly states that cyphenothrin should be used in a concentration range of from 30 to 60% by weight, which is well outside of any of the claimed ranges for cyphenothrin in the challenged claims. As Patent Owner points out, a lower range within the claimed range is called out for other α- cyanopyrethroids with the possible use of a synergist (that is not required in the challenged claims), but not for cyphenothrin. Prelim. Resp. 7–8, 21, 29– 32. We agree with Patent Owner that Petitioner has failed to show why one of ordinary skill in the art would ignore the express teaching of Sirinyan and lower the concentration of cyphenothrin to a claimed range in a formulation with fipronil. Garden does not provide any such impetus. As Patent Owner states, Garden describes the activity of cypermethrin and alphacypermethrin (two particular species of the α-cyanopyrethroid genus) without fipronil and without additionally providing any specific teaching with respect to cyphenothrin except to include it in a listing as an α-cyanopyrethroid. Prelim. Resp. 8 (citing Ex. 1006, Examples 1-15); Ex. 1006, 2:15–33 (stating preferred compounds include cyphenothrin). The listing of cyphenothrin as one of a list of preferred pyrethroids, without more, would not suggest to one of skill in the art that a lower amount of cyphenothrin should be used in a formulation with fipronil.” slip op. at 12

  • PTAB / AIA Trials › Real party in interest / privityNot reached

    “E. Real Parties-In-Interest Patent Owner asserts that Merial Limited, Merial LLC, and Sanofi had a measure of control over this proceeding requiring them to be named as real parties-in-interest. Pet. 9–17. Because we have found that Petitioner has failed to show a reasonable likelihood that it would prevail on any challenged claim, we need not address whether these parties constitute real parties-in-interest. Lumentum Holdings, Inc. v. Capella Photonics, Inc., IPR2015-00731, slip op. at 5 (PTAB March 2, 2016) (holding satisfying the requirements of 35 U.S.C. § 312(a) is not jurisdictional). Any real party-ininterest issue is moot.” slip op. at 14

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

    “Neither party believes that any claim term or phrase needs to be expressly interpreted. See Pet. 10; Prelim. Resp. 5–39 (offering no express 1 PCT App. WO 2008/080542 A2, published Jul. 10, 2008 (Ex. 1004, “Sirinyan”). The Sirinyan reference is a German-language reference. Petitioner provided a certified English-language translation (Ex. 1005). 2 US Patent 4,902,510, issued Feb. 20, 1990 (Ex. 1006, “Garden”). 3 Mark Suarez, EPA Product Performance/Efficacy Review for Sergeant’s Cyphenothrin Squeeze-On for Dogs, Sergeant’s Cyphenothrin + IGR Squeeze-On for Dogs, and Sergeant’s Cyphenothrin + Methoprene Squeeze- On for Dogs, Nov. 7, 2006 (Ex. 1007, “the EPA Review”). constructions). We agree that we do not need to interpret expressly any claim term or phrase to resolve whether a trial should be instituted. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 4

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,614,244
• Bioactive Laboratories v. BTG International Inc.Rehearing denied
  PTAB · Aug 2, 2016 · IPR2015-01305 · APJ Toni R Scheiner · IPR · Rehearing

  The Board denied BioActive Laboratories’ rehearing request, leaving institution denied for claims 1–22 because the ’352 patent was not shown to be prior art.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “ANALYSIS When considering a request for rehearing, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2

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

    “After reviewing the arguments and evidence presented in the Petition, however, we were not persuaded that Petitioner had shown that the ’352 patent fails to provide proper written description support or enablement for the claims of the ’414 patent. Accordingly, we were not persuaded that the ’352 patent is prior art to the claims of the ’414 patent and declined to institute an inter partes review on grounds based on the ’352 patent. Dec. 10–11.” slip op. at 3

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable

    “anticipated by, and claims 8 and 19 are unpatentable over U.S. Patent No. 4,489,352 (Ex. 1004, “the ’352 patent”). Petitioner acknowledged that the ’352 patent “is listed in the priority chain on the face of the ’414 patent” (Pet. 5), and that the specifications of the ’352 patent and the ’414 patent are identical (id. at 29), but argued that: [T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “[T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2

  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 8,048,414
• Benitec Biopharma Limited v. Cold Spring Harbor LaboratoryInstitution denied
  PTAB · Mar 23, 2016 · IPR2016-00015 · APJ Robert A Pollock · IPR · Institution

  Institution was denied for claims 1–20 because Petitioner did not show a reasonable likelihood of proving unpatentability based on Zamore, Graham, or the asserted obviousness combinations.

  RulingsInstitution decision

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

    “For the reasons provided below, we determine Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’599 patent. See 35 U.S.C. § 314(a). We, therefore, deny the Petition for an inter partes review.” slip op. at 2

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

    “In the present matter, the parties do not dispute the meaning of any claim term, nor, for the purposes of our decision, do we find that any term requires express construction. See Pet. 5; Prelim. Resp. 9.” slip op. at 6

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “unexpired patent according to its broadest reasonable construction in light of the specification of the patent in which it appears. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275–79 (Fed. Cir. 2015), cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890 (mem.) (2016). Under that standard, and absent any special definitions, we assign claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention,15 in the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms which are in controversy need to be construed, however, and then 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).” slip op. at 6

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

    “Ex. 1001, 1; Pet. 8: Prelim. Resp. 22. Zamore issued from a non-provisional application filed on July 12, 2002, and claiming benefit of priority under 35 U.S.C. § 119(e) of the ’185 provisional application, filed on July 12, 2001. Ex. 1003, (21), (22) (60), 1:5–7. Accordingly, Zamore is only available as prior art under § 102(e) if Petitioner can show that Zamore is entitled to the earlier filing date of the ʼ185 provisional application. To make such a showing, Petitioner must demonstrate that the ʼ185 provisional application provides written descriptive support for at least one claim of the Zamore patent. See, e.g., Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1381 (Fed. Cir. 2015) (“A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112, ¶ 1.”).” slip op. at 7

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,383,599
• Pharmacosmos A/S v. Luitpold Pharmaceuticals, Inc.Institution denied
  PTAB · Jan 8, 2016 · IPR2015-01495 · APJ Toni R Scheiner · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–5, 7, 8, 11, 12, 15–17, and 20 were unpatentable.

  RulingsInstitution decision

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

    “June 24, 2015, requesting an inter partes review of claims 1–5, 7, 8, 11, 12, 15–17, and 20 of U.S. Patent No. 8,895,612 B2 (Ex. 1001, “the ’612 patent”). Luitpold Pharmaceuticals, Inc. (“Patent Owner”) filed a Preliminary Response (Paper 7, “Prelim. Resp.”) on October 12, 2015. We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the information presented in the Petition and the Preliminary Response, we conclude that Petitioner has not established a reasonable likelihood that it would prevail in its challenges to at least one of the claims of the ’612 patent. Accordingly, we decline to institute an inter partes review of the challenged claims.” slip op. at 2

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

    “Dr. Linhardt’s analysis, however, rests on a series of assumptions in order to arrive at the claimed administration rate of fifteen minutes or less. For example, one must first assume a subject weighing eighty kilograms, then choose to incorporate the greatest possible amount of the iron oxide polyol (320 mg) in the largest volume (15 ml), then further increase the total single dose to 600 mg (0.6 grams) using the same dilution, and then choose a shorter administration time from the broader calculated range of less than 28 minutes. At best, Dr. Linhardt’s testimony establishes that it is possible to arrive at the requisite amount and rate by selecting a particular combination of variables disclosed by Groman. Such picking and choosing, however, is improper in the context of an anticipation challenge. See In re Arkley, 455 F.2d 586, 587 (CCPA 1972). We determine that Petitioner has not established that Groman discloses administering a single dosage unit of at least about 0.6 grams of elemental iron in about 15 minutes or less, as required by claim 1, and therefore, has not demonstrated a reasonable likelihood of establishing that Groman anticipates claim 1. Claims 2–5, 15, 16, and 20 Each of these claims depends directly or indirectly from claim 1, and, therefore, incorporates the requirement that the iron carbohydrate complex is administered in fifteen minutes or less. Accordingly, the challenge to these claims suffers from the same deficiency as the challenge to claim 1. 11 For the foregoing reasons, we conclude that Petitioner has not demonstrated a reasonable likelihood of showing that claims 1–5, 15, 16, and 20 are anticipated by Groman.” slip op. at 11

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

    “the assertion that “iron polyisomaltose and iron dextran should be regarded as synonyms for the purpose of claim construction” (Pet. 13), “[b]ecause the specification states that ‘[e]xamples of iron carbohydrate complexes include . . . iron polyisomaltose (iron dextran),’ and because the specification provides no basis for differentiating between them” (id. (citing 1001, 10:54)). Petitioner acknowledges that “there are instances[ ] where ‘polyisomaltose’ is used to refer to dextran that has been processed to remove most or all of its branches” (id. at 14), but contends “[r]egardless of the meaning of this term to those of ordinary skill in the art, the patentee here explicitly defined polyisomaltose in the specification to be interchangeable with dextran, and that definition should control” (id. at 13 n.6). Patent Owner contends that “the parenthetical ‘dextran’ should not be considered to indicate equivalence” (Prelim. Resp. 30), and that Petitioner’s construction is inconsistent with the understanding in the art of the term polyisomaltose, and with the specification of the ’612 patent (id. at 29). Patent Owner contends that there is ample evidence of record that the two terms are not freely interchangeable (id.), and that “Petitioner’s construction 13 also ignores the disparaging remarks about dextran in the specification” (id.at 30). For example, Patent Owner points to the statement in U.S. Patent No. 3,100,202 to Müller, issued August 6, 1963, and cited by the Examiner during prosecution: “While ‘polyisomaltose’ is a term used loosely for ‘dextran’ . . . the latter is a compound of very high molecular weight, whereas polyisomaltose is a degradation product of dextran consisting of polymerized glucose residues joined predominantly by 1,6 linkages.” Prelim. Resp. 28 (citing Ex. 1010, 2:48–53). We further note statements in the ’612 patent to the effect that “serious and life-threatening reactions occur most frequently with iron dextran” (Ex. 1001, 1:43–44); “[i]ron dextran . . . has been associated with an incidence of anaphylactoid-type reactions” (id. at 1: 51–53); and “[t]his high incidence of anaphylactoid reactions is believed to be caused by the formation of antibodies to the dextran moiety” (id. at 1:56–58). Finally, we note that the’612 patent emphasizes that the iron carbohydrate complexes of the invention preferably have various characteristics—including a “non-immunogenic carbohydrate component” and “substantially no cross-reactivity with anti-dextran antibodies” (id. at 3:28–31). Having considered the evidence of record, we agree with Patent Owner that Petitioner has not established adequately that the claim term “iron polyisomaltose” would be understood by one of ordinary skill in the art in the context of the entire disclosure of the ’612 patent to encompass Marchasin’s “iron-dextran.” Therefore, we are not persuaded that Petitioner 14 has established that Marchasin discloses administering an iron polyisomaltose complex. Accordingly, we conclude that Petitioner has not demonstrated a reasonable likelihood of showing that claims 1 and 20 are anticipated by Marchasin.” slip op. at 13

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

    “We agree with Patent Owner that Petitioner has not established that one of ordinary skill in the art would have had a reason to combine the teachings of Geisser and Groman in the manner required by the challenged claims. As discussed above in connection with the anticipation challenge of claim 1 based on Groman, Petitioner has not established that Groman discloses administering a single dosage unit of at least about 0.6 grams of elemental iron in about 15 minutes or less, as required by claim 1. Nor has Petitioner explained why it would have been obvious for one of ordinary skill in the art to choose, from all the variables disclosed in Groman, those parameters that would result in administering at least about 0.6 grams of elemental iron in less than fifteen minutes, much less an even larger dose of at least about 1.0 gram. Having considered the information presented in the Petition, and Patent Owner’s Preliminary Response, we are not persuaded that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing that challenged claims 7, 11, and 12 are unpatentable over Geisser and Groman.” slip op. at 18

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,895,612
• Coalition For Affordable Drugs Vii LLC v. Pozen Inc.Institution denied
  PTAB · Dec 17, 2015 · IPR2015-01344 · APJ Jacqueline Wright Bonilla · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–19 unpatentable over the asserted obviousness combinations or by anticipation.

  RulingsInstitution decision

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

    “Petition (Paper 1, “Pet.”) requesting an inter partes review of claims 1–19 of U.S. Patent No. 8,858,996 B2 (Ex. 1001, “the ’996 patent”). Pozen Inc. (“Patent Owner”) filed a Preliminary Response. Paper 14 (“Prelim. Resp.”).1 Under 35 U.S.C. § 314, we may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2

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

    “The specification of the ’996 patent does not define expressly the term “inhibit.” Considering the ordinary and customary meaning of the term in view of the specification and the claims themeselves, however, we construe “inhibit” to mean prevent (stop), hinder, or restrain. Ex. 1035, 2; Ex. 1036, 49; Ex. 2006, 3; Ex. 2007, 3. For example, claim 1 of the ’996 patent recites that “release of at least a portion” of napoxin “is inhibited unless the pH” is 3.5 or higher (emphasis added). Claim 12 recites a “coating that inhibits release of said naproxen from said core layer unless said dosage form is in a medium with a pH of 3.5 or higher” (emphasis added). Thus, “inhibits” refers to preventing, hindering, or restraining the release of naproxen “unless” the dosage form is exposed to a pH of 3.5 or higher. The use of “unless” in claim 1 and 12 and “at least a portion” in claim 1 indicates that the terms “inhibited” and 7 “inhibits” in the claims do not encompass a “slowing down” of a release when the pH is below 3.5 (which would make “at least a portion” superfluous in claim 1), but rather refers to no release of “at least a portion” (claim 1) or all (claim 12) of the drug “unless” the dosage form is at a pH of 3.5 or higher.” slip op. at 7

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

    “We agree that Petitioner has not established that the teachings of Goldman, Remington, and Lindberg would have given an ordinary artisan a reason to formulate a tablet with the structural and functional features required by the challenged claims. Although Goldman discloses a combination dosage form comprising a PPI and NSAID (discussed above), Petitioner does not point to anything in Goldman that describes or suggests adequately why one would have prepared, for any reason, a composition as claimed, where at least some PPI (i.e., esomeprazole) is released regardless of pH and the release of at least some NSAID (i.e., naproxen) is inhibited unless the pH is 3.5 or higher (e.g., via a coating). Moreover, although Goldman incorporates Remington’s discussion of oral solid dosage forms by reference (Ex. 1004, 6:26–33), Petitioner does not identify anything in Goldman that points to any particular dosage form 14 among the many disclosed by Remington. Goldman’s citation to Remington generally in relation to “[v]arious conventional techniques for preparing medicament tablets or caplets” does not persuade us that an ordinary artisan would have made the connection that Petitioner contends. Id.; Pet 11, 14– 16, 22–25. Nor does Petitioner explain adequately how Lindberg remedies the deficiencies discussed above in relation to Goldman and Remington.” slip op. at 14

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

    “In an inter partes review, the burden is on the petitioner to show a reasonable likelihood that it would prevail on a ground of unpatentability. 35 U.S.C. § 314(a). With respect to entitlement to any earlier effective filing date, however, a patent owner is not presumed to be entitled to the earlier filing dates of ancestral applications that do not share the same disclosure, such as in a continuation-in-part situation. Focal Therapeutics, Inc. v. SenoRx, Inc., Case IPR2014-00116, slip op. at 9 (Paper 8) (PTAB Apr. 22. 2014); see also PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305–06 (Fed. Cir. 2008) (stating that once a defendant establishes that a reference is § 102(b) prior art, burden is on patent owner to come forward with evidence proving priority to an earlier filing date). Nonetheless, a petitioner first must raise the issue by identifying, specifically, the features, claims, and ancestral applications allegedly lacking written description support for the claims based on the identified features. Focal Therapeutics, 24 Case IPR2014-00116, slip op. at 10 (Paper 8). Then, the patent owner must make a sufficient showing of entitlement to earlier filing date(s), in a manner that is commensurate in scope with the specific points and contentions raised by the petitioner. Id. Here, Petitioner cites nothing in the record to support its assertions regarding a lack of written description in the pre-2003 applications, other than to refer to those pre-2003 applications generally. Pet. 47–51. When asserting a “break in priority,” Petitioner does not identify, specifically, the features or claims that allegedly lack written description support. Instead, Petitioner discusses in very general terms what “the ’996 Patent claims are broad enough to encompass” and what the “pre-2003 applications disclose” (id. at 50–51) without referring to any specific challenged claim or providing specific citations to any specification at issue. Even if we assume Petitioner adequately raises the issue, however, we are persuaded that Patent Owner provides a sufficient showing of entitlement to the filing date of at least the ’216 application (the ’255 Publication), in a manner that is commensurate in scope with the points and contentions raised by Petitioner. For example, Patent Owner points to paragraphs 10, 13, and 82 in the ’255 Publication. Prelim. Resp. 35–38 (citing Ex. 1008 ¶¶ 10, 13, 82). Paragraph 10 describes a release of NSAID that “minimizes the adverse effects of the NSAID on the gastroduodenal mucosa.” Ex. 1008 ¶ 10 (emphasis added). Similarly, paragraph 13 describes “preferably provid[ing] for coordinated drug release” that 25 “reduces the deleterious effects of the NSAID on the gastroduodenal mucosa.” Id. ¶ 13 (emphasis added). Paragraph 13 also describes a “most preferred form” where an inner core is “surrounded by a polymeric barrier coating that does not dissolve unless the surrounding medium is at a pH of at least 3.5.” Id. (emphasis added). Paragraph 82 in Example 7 also refers to a coordinated delivery dosage that provides “the delayed release” of naproxen. Id. ¶ 82 (emphasis added). Although we recognize that the ’255 Publication (and indeed the ’996 patent specification itself) does not use the exact words “at least a portion” in relation to a release of naproxen, the ’255 Publication “does not have to describe exactly the subject matter claimed.” Vas–Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (citing In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989). Rather, the description must “‘reasonably convey[] to the artisan that the inventor had possession at that time of the later claimed subject matter.’” Id. at 1563 (quoting Ralston Purina Co. v. Far– Mar–Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985)). Thus, we consider whether the ’255 Publication as a whole conveys to one of ordinary skill in the art, either explicitly or inherently, that the inventors of the ’996 patent invented the subject matter claimed in the challenged claims. Reiffin v. Microsoft, 214 F.3d 1342, 1346 (Fed. Cir. 2000) (citing Vas–Cath, 935 F.2d at 1563). Here, words such as “minimizes,” “reduces,” and “delayed” in paragraphs 10, 13, and 82 in the ’255 Publication, as well as disclosure of 26 different preferred forms in paragraph 13, indicate that the inventors possessed a dosage form and/or coordinated drug release where a portion (e.g., a small portion) of the NSAID (e.g., “most preferred NSAID” naproxen (Ex. 1008 ¶ 12)) was released when the pH of the medium was below 3.5, even if most or nearly all of the drug was not released until the pH was 3.5 or higher. See, e.g., id. ¶ 13 (also stating in one sentence that in “a preferred embodiment, the unit dosage form is a multilayer tablet, having an outer layer comprising the acid inhibitor and an inner core which comprises the NSAID” without referring to when or under what conditions NSAID is released). Moreover, every species in a genus need not be described in order for the genus to meet the written description requirement. Regents of U. California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) (citing Utter v. Hiraga, 845 F.2d 993, 998–99 (Fed. Cir. 1988)). In this case, the genus at issue has two easily identified species, i.e., inhibiting the release of all or a portion of a drug unless a pH is reached, as opposed to a complex chemical genus, for example, encompassing a large number of possible species. Id.; see also Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336, 1352 (Fed. Cir. 2011) (stating that whether disclosure of a species supports a genus “depends upon the state of the art and the nature and breadth of the genus,” finding sufficient support where the genus consisted of only two species). We are persuaded that the ’255 Publication as a whole conveys to one of ordinary skill in the that the inventors of the ’996 patent” slip op. at 24

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,858,996

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