• Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01594 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–3 and 5–8 are unpatentable as anticipated by Hays or obvious over the listed combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

  RulingsFinal written decision

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

    “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, claim 1, from which claims 2–8 depend, recites the dosed amount of glycopyrrolate in solution as “an amount ranging from 3.0 wt. % to 4 wt. %.” Because claim 1 describes the dosed amount by the strength/concentration, it supports our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

  • BurdenMixed

    “Petitioner may well be correct that preferring a non-anticholinergic does not necessarily exclude administering “another oral and/or topical therapy for reduction of sweating,” as required by challenged claim 4. Petitioner, however, does not point to any credible evidence or otherwise explain why an ordinary artisan would have chosen another therapy to reduce sweating to be administered in combination with glycopyrrolate. Without some articulated reasoning with rational underpinning as to why an ordinary artisan would have added a second therapeutic for reducing sweating to the transdermal patch of Bodor, which uses the anticholinergic to eliminate the formation of an aqueous layer between the delivery system and the skin to enhance the penetration of the transdermal drug being delivered, Petitioner has not met its burden of demonstrating that claim 4 20 would have been obvious over the combination of Bobrove and Bodor. See KSR, 550 U.S. at 418.” slip op. at 20

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

    “(citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. at 31 (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 72. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 29 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

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

    “Bobrove specifically teaches applying a “roll on” glycopyrrolate solution. Ex. 1008, 6:26–27, 6:36–37. It, however, also generally teaches that glycopyrrolate is administered topically. Id. at 4:1. Thus, one of ordinary skill in the art would have had a reason to look for other means to apply glycopyrrolate. As Dr. Guy testifies, “[t]here are a limited number of ways to topically deliver a drug to a patient’s skin.” Ex. 1003 ¶ 16. In addition, Bobrove suggests to avoid the eyes, nose, and mouth during the topical administration. Ex. 1008, 5:37–39. Given these considerations, Bodor provides an effective alternative: a cotton cloth to absorb the drug and rub it on the skin. Ex. 1030, 15:39–54; see also Ex. 1003 ¶ 17 (explaining that, at the time of the invention, an ordinary artisan would have known that use of medicated pads “allowed for topical application of a solution, for example to a subject’s face, while excluding application to sensitive areas such as the eyes or mucous membranes”). Thus, we conclude Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor. In sum, Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor, and that the combination teaches each and every limitation of claims 1 and 2. Claims 4, 5, and 8” slip op. at 19

  Patent outcomesUS 8,252,316 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,252,316
• Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01593 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–3 and 5–10 are unpatentable as anticipated by Hays or obvious over the stated combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

  RulingsFinal written decision

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

    “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, the challenged claims recite the dosed amount of glycopyrrolate in solution as “an amount ranging from 1.0 wt. % to 6 wt. %” (claim 1); “an amount ranging from 2.0 wt. % to 6.0 wt. %” (claim 9); and “an amount ranging from 2.0 wt. % to 4.0 wt. %” (claim 10). Because the claims describe the dosed amount by the strength/concentration, they support our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

  • Skill levelSkill level board ownOther

    “The parties disagree over the level of ordinary skill.8 See Pet. 17–18; PO Resp. 3; Reply 9. For purposes of this Decision, we do not need to resolve this dispute because the prior art itself reflects an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “not qualify as one of ordinary skill in the art because he is not a clinician, physician, or pharmacist. PO Resp. 3–4. We disagree with Patent Owner on this issue. All asserted references relate to topical administration of pharmaceutical compositions. See, e.g., Ex. 1008, 4:1; Ex. 1010, 2:35–38; Ex. 1030, 3:60–61. In addition, the challenged ’524 patent relates to the topical delivery of glycopyrrolate to reduce excessive sweating and minimize side effects. Ex. 1001, Abstract, 1:13–21. Dr. Guy has over 30 years of experience in fields including topical drug delivery, transdermal” slip op. at 16

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

    “water base and a vanishing cream base in 0.5 to 1% concentration. It completely controls gustatory sweating for several days or more.” Pet. 30 (citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. at 31 (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 90. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 31 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

  Patent outcomesUS 8,679,524 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,679,524
• Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd. And Alkermes Controlled Therapeutics, Inc.Institution denied
  PTAB · Nov 30, 2016 · IPR2016-01095 · APJ Lora M Green · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–13 and 17–23 were unpatentable over Goldenheim alone or in the asserted combinations.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of claims 1‒13 and 17‒23. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2

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

    “[U]nless a reference discloses 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, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102. . . . [I]t is not enough that the prior art reference . . . includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008)). Here, as noted by Patent Owner, Petitioner is using disparate teachings of the Goldenheim reference to attempt to establish that the claims of the challenged patent are anticipated by that reference. The disclosure of Goldenheim of a viscosity of 35 cp in certain instances is a single sentence from that document, and Goldenheim provides no guidance as to what those circumstances may be. Petitioner has not sufficiently established that the ordinary artisan would have read that viscosity limitation into the formulation used by Example 16, which Petitioner relies upon to meet the concentration of microparticles required by challenged claim 1. In that regard, we note that Example 16 does not mention viscosity, and specifically teaches the use of an injection vehicle of 0.5% CMC and 0.1% Tween 80 in water. Ex. 1004, 52:27‒28” slip op. at 10

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

    “references remedy the deficiencies discussed above with respect to the anticipation rejection. As the Supreme Court pointed out in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” Id. at 418. Rather, the Court stated: [I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does . . . because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known. Id. at 418-419 (emphasis added); see also id. at 418 (requiring a determination of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue”) (emphasis added). In the instant proceeding, Petitioner has not provided a reason, however, as to why the ordinary artisan would have taken Goldenheim’s one mention of a viscosity of 35 cp and applied it to the formulation in Example 16 relied upon by Petitioner to meet the concentration limitation of independent challenged claim 1. Specifically, as noted by Patent Owner (Prelim. Resp. 20), Goldenheim teaches that “[i]n certain instances, the final reconstituted product viscosity may be, e.g., about 35 cps” (Ex. 1004, 35:11) but does not explain what those instances may be, much less tying that disclosure to the concentration of microparticles used in Example 16, which makes no mention of viscosity.” slip op. at 14

  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 6,667,061
• Hamilton Beach Brands, Inc. v. F’Real Foods, LLCInstitution denied
  PTAB · Nov 30, 2016 · IPR2016-01105 · APJ Brian P Murphy · IPR · Institution

  Institution was denied because Petitioner did not show a reasonable likelihood of proving claims 1 and 6–11 anticipated by Neilson or claims 1 and 5–11 obvious over the asserted combinations.

  RulingsInstitution decision

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

    “October 6, 2014—the date the 2014 Complaint alleging infringement of the ’658 patent was served on Petitioner. Prelim. Resp. 5, 11. It is undisputed, however, that Patent Owner did not own the ’658 patent at the time the 2014 Complaint was filed and served. Pet. 4; Prelim. Resp. 7; Ex. 1030 ¶¶ 5–7. Title to the ’658 patent was transferred to Patent Owner by an assignment executed January 25, 2016. Pet. 4; Prelim. Resp. 9; Ex. 1030 ¶ 7, Ex. C (patent assignment). Accordingly, Patent Owner lacked standing to sue for infringement of the ’658 patent at the time the 2014 Complaint was filed and served. Paradise Creations, Inc. v. UV Sales, Inc., 315 F.3d 1304, 1309 (Fed. Cir. 2003) (“[I]n order to assert standing for patent infringement, the plaintiff must demonstrate that it held enforceable title to the patent at the inception of the lawsuit.”). The patent counts of the 2014 Complaint were jurisdictionally defective, and the defect could not be cured after the filing date of the complaint, e.g., by a subsequent assignment or by joining the patent title holder to the lawsuit. Alps S., LLC v. Ohio Willow Wood Co., 787 F.3d 1379, 1385 (Fed. Cir. 2015), cert. denied, 136 S. Ct. 897 (2016) (“The party asserting patent infringement is ‘required to have legal title to the patents on the day it filed the complaint and that requirement can not be met retroactively.’”) (quoting Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359, 1366 (Fed. Cir. 2010)). The Delaware district court was required to—and actually did— dismiss the patent infringement counts of the 2014 Complaint for lack of Article III standing. Ex. 1031 n.1 (Delaware district court order granting motion for voluntary dismissal: “the court lacks jurisdiction to make a judgment on the merits”); see also, Abraxis, 625 F.3d at 1367 (“[T]he action must be dismissed because [plaintiff] lacked standing on the day it filed the action.”); Schreiber Foods, Inc. v. Beatrice Cheese, Inc., 402 F.3d 1198, 1203 (Fed. Cir. 2005) (“[I]f the original plaintiff lacked Article III initial standing, the suit must be dismissed, and the jurisdictional defect cannot be cured by the addition of a party with standing, . . . nor by the subsequent purchase of an interest in the patent in suit.”) (citing Paradise, 315 F.3d at 1309). Thus, the allegation of infringement of the ’658 patent in the 2014 Complaint was not a proper federal pleading and did not trigger the one-year time period under 35 U.S.C. § 315(b). Petitioner was not served with a complaint properly alleging infringement of the ’658 patent until January 2016. The instant petition was filed in May 2016. Accordingly, the Petition is not time-barred under § 315(b).” slip op. at 9

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

    “unpatentable under 35 U.S.C. § 102(b) and claims 1 and 5–11 as unpatentable under § 103. Pet. 9. Based on the arguments and evidence presented in the Petition and Preliminary Response, we determine Petitioner has not established a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Therefore, institution of an inter partes review is denied.” slip op. at 2

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

    “of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, and absent any special definitions, we give 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. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Petitioner and Patent Owner offer competing constructions for several claim terms. Pet. 18–20; Prelim. Resp. 26–35. We determine that only the following claim terms require express construction for purposes of this Decision. 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.’”) (citation omitted).” slip op. at 13

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

    “position.” During a mixing operation, the ’658 patent describes how the cup holder is reciprocated to move axially upward so the mixing element is in a position within the liquid-filled cup, i.e. the recited “first position,” then reciprocated downward so the mixing element is moved upward to the recited “second position” closer to the opening at the top of the cup, “to allow the blade to pass through the full contents of the cup more than one time.” Ex. 1001, 3:58–64. When the mixing element is moved upward within the cup to the second position, the weight of the splash shield must be sufficient to keep the liquid-filled cup in the cup holder. Id. at 4:3–10 (“heavy enough to create sufficient downward force on the cup to overcome any upward force created by the mixing blade being moved upwardly in the cup”). The force generated by upward movement of the mixing element is not further described in the ’658 patent, although the ’658 patent provides a preferred embodiment where a splash shield weighing 5 pounds (dependent claim 5) provides sufficient downward force to perform the recited function. Id. at 4:20–23. Petitioner argues that “sufficient mass” in claim 1 should be construed in accordance with the interpretation allegedly offered by Patent Owner in the dismissed patent action: “the splash shield applies sufficient weight to the top of the cup to retain the cup in the cupholder during mixing.” Pet. 19 (no citation). Petitioner further argues that “the mass of the splash shield” limitation in claim 6 should be construed in accordance with the construction allegedly offered by Patent Owner in the dismissed patent action: “the splash shield applies sufficient weight to the top of the cup to prevent separation of the cup from the cupholder during mixing.” Id. (no citation). Patent Owner responds with a slightly different interpretation of a splash shield having a “sufficient mass”: “heavy enough to retain the vessel within the holder during relative movement of the mixing element and vessel.” Prelim. Resp. 31 (citing Ex. 1001, 4:3–24; Ex. 2025 (definition of “sufficient”)). Both parties appear to agree that the ’658 patent describes the “sufficient mass” of the splash shield in functional terms as enough weight to retain the vessel or cup within the holder during mixing. Ex. 1001, 3:65– 4:23. Based on the description provided in the ’658 patent, the claim language at issue in claim 1 – “the splash shield having sufficient mass to retain the vessel within the holder during relative movement of the mixing element and vessel from the first position to the second position when liquid is present in the vessel” – is entitled to its plain and ordinary meaning: “the splash shield is heavy enough to create sufficient downward force on the vessel so as to retain the vessel within the holder when the mixing element moves upwardly in the vessel from the first position to the second position when liquid is present.” See Ex. 1001, 4:3–10 (“heavy enough to create sufficient downward force on the cup to overcome any upward force created by the mixing blade being moved upwardly in the cup”). The claim language in claim 6 “the mass of the splash shield preventing separation of the holder and the vessel during translation” is similarly construed to mean “the splash shield is heavy enough to create sufficient downward force on the vessel so as to prevent separation of the holder and the vessel during translation of the mixing element or holder.”” slip op. at 14

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 7,520,658
• Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratory, Inc. v. Helsinn Healthcare S.A.Institution denied
  PTAB · Aug 17, 2016 · PGR2016-00008 · APJ Toni R Scheiner · PGR · Institution

  The Board denied institution because Petitioner did not show that claims 1–19 lacked written-description support or violated the AIA on-sale bar.

  RulingsInstitution decision

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

    “35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard is set forth in § 324(a), which provides that a post-grant review shall not be instituted unless “the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, we determine that Petitioner has failed to demonstrate that it is more likely than” slip op. at 2

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

    “The written description requirement is satisfied when the specification “set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what 7 Patent Owner additionally provides Appendix A to the Preliminary Response. Appendix A purportedly maps the requirements of claims 1–19 to the specification. 11 is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004). Here, it is undisputed that the specification describes formulations comprising the same ingredients, in the same amounts, concentrations, and combinations required by the challenged claims. Given this disclosure, one of ordinary skill in the art could hardly fail to recognize a description of the claimed formulations in the specification, whether or not the claims recite that the formulations are stable.” slip op. at 11

  • Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)Not shown unpatentableNot shown unpatentable

    “A person shall be entitled to a patent unless—(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . . As an AIA first-inventor-to-file patent, the ’942 patent is subject to AIA § 102(a)(1). Thus, the dispositive issue in this case is whether § 102(a)(1) requires a public sale or offer for sale of the claimed invention to trigger the on-sale bar.” slip op. at 18

  § 102 anticipation§ 112 disclosure
  Patents in suitUS 9,173,942
• 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
• Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd.Some claims unpatentable
  PTAB · Jul 7, 2016 · IPR2015-00529 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–8 and 10–19 are unpatentable as obvious over the INOmax label, Bernasconi, Loh, and Goyal; claims 1, 7, 12, and 14 are also anticipated and obvious over the INOmax label.

  RulingsFinal written decision

  • Expert testimonyOther

    “method of providing pharmaceutically acceptable nitric oxide gas requires providing information to the medical provider to safely administer the nitric oxide gas,” thus “confirm[ing] that the ‘providing . . . information’ step is functionally related to the steps in the claimed method.” PO Resp. 31–33. As an initial matter, whether the claims should be interpreted as requiring such a functional relationship is a legal conclusion. See PO Resp. 13. Patent Owner’s conclusion regarding functional relationship between claim terms is based, at least in part, on an overly-limited reading of “pharmaceutically acceptable nitric oxide gas,” as discussed above. See PO Resp. 27. Further, we do not read the transcript testimony relied on by Patent Owner as clearly admitting a functional relationship between the steps of “providing pharmaceutically acceptable nitric oxide gas” and the information of (ii). See PO Resp. 31–32 (citing Ex. 2022, 78:15–80:4, 81:11–22, 111:2–17)). To the contrary, Dr. Beghetti appears to have testified that the claim elements are not directly related. Ex. 2022, 86:10– 25. Although Patent Owner points to In re Distefano, 808 F.3d at 848, as evidence that a “printed matter analysis includes ‘factual findings’” (PO Sur Reply 4, n.6), which inform the ultimate legal conclusion, we do not find the evidence as a whole compelling.” slip op. at 19

  • ExcludeMotion to exclude, deniedOther

    “IV. PETITIONER’S MOTION TO EXCLUDE Petitioner moves to exclude certain portions of Ex. 2024 on the grounds that they “are declarations and supporting materials submitted during patent examination . . . in violation of 37 C.F.R. § 42.53(a)” and “lack foundation (FRE 602) and authentication (FRE 901) and constitute impermissible hearsay (FRE 901).” Paper 31, 2–3. Petitioner likewise moves to exclude Exhibit 2029 as not relied on in the Patent Owner Response or by Patent Owner’s expert. Id. at 3. As we do not rely on the objected-to materials in this opinion, we dismiss the motion as moot.” slip op. at 45

  • Strike new argumentNew argument disregardedOther

    “V. OBJECTIONS TO DEMONSTRATIVES The parties also submit competing objections to demonstrative exhibits used at trial. Papers 46, 47. Specifically, both parties object to certain slides as setting forth a new argument not previously made in any paper. Papers 46, 47. The parties are reminded that demonstrative exhibits are illustrative only and are not part of the trial record. Indeed, in accordance with our Order on requests for oral argument, neither party filed its demonstratives with the Board. See Paper 45, 2 (“Notwithstanding 37 C.F.R. § 42.70(b), the parties shall not file any demonstrative exhibits in this proceeding without prior authorization from the Board. 37 C.F.R. § 42.5(b). Demonstrative exhibits are intended to be visual aids to assist a party in making its oral presentation and will not be entered into the record of these proceedings.”). Nevertheless, in this Final Written Decision, we rely on the arguments presented properly in the parties’ briefs and the evidence of record and do not consider any new arguments not previously set forth in any paper. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). (“No new evidence or arguments may be presented at the oral argument.”).” slip op. at 45

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

    “The Applicant amended the preamble of the rejected independent claims to recite “[a] method of providing pharmaceutically acceptable nitric oxide gas,” as presently set forth in claims 1 and 7. Id. at 746–747. Subsequent to the amendment, the Examiner withdrew the objection. Id. at 765; see id. at 733 (“If all the priority issues are resolved then it appears that the primary reference in the 103 rejection will no longer be prior art.” (italics omitted)). On pages 19 and 20 of its Response, Patent Owner argues that the preamble is, therefore, limiting in light of Catalina Mktg. International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), which holds that “clear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates the use of the preamble to define, in part, the claimed invention.” Although the prosecution history shows that amendment of the preamble only indirectly distinguished the claims over the prior art by establishing an earlier priority date, we conclude that both the Applicant and the Examiner treated the preamble as a claim limitation. Accordingly, we agree with Patent Owner that the preamble language “pharmaceutically acceptable nitric oxide gas” is limiting.” slip op. at 11

  Patent outcomesUS 8,846,112 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,846,112
• Genzyme Corporation v. Genentech, Inc. And City Of HopeInstitution denied
  PTAB · Jun 23, 2016 · IPR2016-00383 · APJ Lora M Green · IPR · Institution

  The Board denied institution because Petitioner failed to show a reasonable likelihood that claims 1–4, 9, 11, 12, 14–20, and 33 were unpatentable over the asserted grounds.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

    “35 U.S.C. § 325(d) states, in relevant part (emphasis added), that “[i]n determining whether to institute or a proceeding under this chapter . . . the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” We have considered the Patent Owner’s arguments, along with the facts and circumstances of the instant proceeding, and we decline to exercise our discretion to deny the Petition under 35 U.S.C. 325(d).” slip op. at 7

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

    “establishes a reasonable likelihood that Petitioner would prevail in any of its challenges of claims 1–4, 9, 11, 12, 14–20, and 33. ORDER In consideration of the foregoing, it is hereby ordered that the Petition is denied.” slip op. at 30

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

    “ii. Analysis “Anticipation requires the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim.” SynQor, Inc. v. Artesyn Techs., Inc., 709 F.3d 1365, 1375 (Fed. Cir. 2013) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Nonetheless, “a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)); see also In re Preda, 401 F.2d 825, 826 (CCPA 1968) (noting that “in considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom”). “Thus, it is not enough that the prior art reference discloses part of the claimed invention, which an ordinary artisan might supplement to make the whole, or that it includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). “The requirement that the prior art elements themselves be ‘arranged as in the claim’ means that claims cannot be ‘treated . . . as mere catalogs of separate parts, in disregard of the part-to-part relationships set forth in the claims and that give the claims their meaning.’” Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010) (quoting Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1459 (Fed. Cir. 1984)).” slip op. at 9

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

    “We agree with Patent Owner that Petitioner has not sufficiently established that the combination of Salser and Ochi renders challenged claims 1–4, 9, 11, 12, 15–20, and 33 obvious. Petitioner’s reason to combine is premised on its assertion that in view of the globulin species of Salser, the ordinary artisan would have looked at Ochi, who teaches the recombinant production of a species of globulin, that is, an immunoglobulin. As noted by Patent Owner (Prelim. Resp. 53–54) and admitted by Petitioner (Pet. 27), the focus of Salser is on gene therapy (Ex. 1002, 1:24–28). Thus, Salser discusses providing a genetic capability, such as the production of a normal gene product when a cell produces an abnormal one, or the production of enzymes that protect the host from cytotoxic agents. Ex. 1002, 2:29–35. In particular, Salser notes that its method may be used to treat human genetic diseases such as hemoglobinopathes. Id. at 17:13–14. Salser does not specifically discuss the use of the method for the production of an immunoglobulin. Ochi looks at the ability of a cloned light chain that is expressed in immunoglobulin-producing hybridoma cells to restore specific antibody production. Ex. 1003, Abstract. The antibody studied is an IgM specific for TNP. Id. at 340. There is no discussion of any therapeutic use of that antibody, nor is there a discussion of therapeutic uses of antibodies in general. Except for its statement that because Salser teaches the globulin genus, and an immunoglobin as taught by Ochi is a species of that genus, Petitioner does not provide a reason why the ordinary artisan would have looked to the anti-TNP IgM of Ochi for use in the gene therapy methods of Salser. At best, Petitioner’s expert makes the statement, when discussing the anticipation challenge over Salser, that “immunoglobulins were inarguably the most important of the globulins from a medical and therapeutic standpoint.” Ex. 1058 ¶ 65. Petitioner’s expert, however, provides no support for that statement. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, neither Petitioner nor its expert point to any evidence that at the time of invention of the ’415 patent that the ordinary artisan was looking at immunoglobulins as targets of gene therapy. As for a reasonable expectation of success, Petitioner contends that is provided by Ochi, who teaches that introduction of an exogenous light chain into an immunoglobulin producing cell allows for assembly with the endogenous heavy chain to produce a functioning antibody. That teaching of Ochi, however, does not provide a reasonable expectation of success of introducing both an exogenous light chain and heavy chain into a cell to produce a therapeutic antibody in vivo as required by Salser.6 We determine, therefore, that Petitioner has not sufficiently demonstrated that the ordinary artisan would have had a reason to combine the immunoglobulin of Ochi with the gene therapy methods of Salser with a reasonable expectation of success of achieving the subject matter of challenged claims 1–4, 9, 11, 12, 15–20, and 33.” slip op. at 24

  § 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
  Patents in suitUS 6,331,415
• Zimmer Biomet Holdings, Inc. / Zimmer Inc. et al. v. Advanced Orthopaedic Solutions, Inc.Institution denied
  PTAB · Jun 7, 2016 · IPR2016-00311 · APJ Lora M Green · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 6–11, 13–15, 19, and 20 were unpatentable over the asserted grounds.

  RulingsInstitution decision

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

    “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 considering the Petition and the Preliminary Response, we determine that Petitioner has failed to demonstrate 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.” slip op. at 2

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

    “We agree with Patent Owner that Petitioner has not sufficiently established that Shavit discloses an insert having a lower surface that is operative to contact a bone screw. Petitioner relies primarily on Figures 1B and 4 of Shavit to establish that the insert contacts the bone screw. As noted by Patent Owner (Prelim. Resp. 16), “[i]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.” Hockerson-Halberstadt, Inc. v. Avia Group Int’l Inc., 222 F.3d 951, 956 (Fed. Cir. 2000). “Ordinarily drawings which accompany an application for a patent are merely illustrative of the principles embodied in the alleged invention claimed therein and do not define the precise proportions of elements relied upon to endow the claims with patentability.” In re Olson, 212 F.2d 590, 592 (CCPA 1954).” slip op. at 16

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

    “In challenging claim 19 over the combination of Shavit and Kilpela, as to the limitation that “said lower surface [of an insert] operative to engage a bone screw extending through said aperture,” Petitioner states that for the reasons discussed as to claim 8, Shavit in view of Kilpela renders that limitation obvious. Pet. 37 (emphasis added). Petitioner relies on that same analysis as to the challenge of claim 19 over the combination of Shavit, Kilpela, and Bramlet. Id. at 46. In its discussion of claim 8 as being obvious over the combination of Shavit and Kilpela, Petitioner relies on Kilpela for a reason to have a longitudinal passageway through the insert. Id. at 28. As to the remaining limitations of claim 8, which depends from claim 6, Petitioner relies on its discussion of claim 6 as being anticipated by Shavit. Id. Petitioner, therefore, does not rely on either Kilpela or Bramlet to make up the deficiency of Shavit as discussed above as to the anticipation challenge of independent claim 6. Thus, for the reasons discussed above in Section II.B.ii.a, we determine that Petitioner has not sufficiently established that claim 19 is rendered by the combination of Shavit and Kilpela, or the combination of Shavit, Kilpela, and Bramlet. Similarly, Petitioner relies on its discussion of independent claims 6, 13, and 19 in contending that claim 8 is rendered obvious by the combination of Shavit and Kilpela (Pet. 28), that claims 14, 15, and 20 are rendered obvious by the combination of Shavit and Kilpela (Pet. 31–33, 39– 40) or by the combination of Shavit, Kilpela, and Bramlet (Pet. 40–45, 47), and that claim 11 is rendered obvious by the combination of Shavit and Bramlet (Pet. 47–48). As Petitioner again does not rely on either Kilpela or Bramlet to remedy the above discussed deficiency of Shavit, we determine also that Petitioner has not sufficiently established that claims 8, 11, 14, 15, and 20 are rendered by the Shavit in combination with Kilpela and/or Bramlet.” slip op. at 18

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

    “We determine that, for purposes of this Decision, none of the terms in the challenged claims require express construction at this time. See, e.g. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 3 Bramlet et al., US Patent No. 6,443,954 B1, issued Sep. 3, 2002 (Ex. 1007) (“Bramlet”). 1999) (noting that only claim terms that are in controversy need to be construed, and then only to the extent necessary to resolve the controversy).” slip op. at 8

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,092,454
• The Johns Hopkins University v. Biocon LimitedInstitution denied
  PTAB · May 12, 2016 · IPR2016-00175 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of proving claim 1 anticipated by or obvious over Bedi.

  RulingsInstitution decision

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

    “CONCLUSION Taking account of the information presented in the Petition and Preliminary Response, we determine that the Petition fails to show that there is a reasonable likelihood that Petitioner would prevail at trial with respect to claim 1 of the ’247 patent. ORDER It is ORDERED that the Petition is denied and no trial is instituted.” slip op. at 10

  • BurdenDenied

    “A. Anticipation by Bedi To establish anticipation, each and every element in a claim, “arranged or combined in the same way as recited in the claim,” must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Claim 1 requires a chimeric fusion protein comprising an “immunomodulating moiety” that “is SEQ ID NO: 4.” Ex. 1001, 69:45, 70:38. Claim 1 specifies that “SEQ ID NO: 4 is attached via the amino acid spacer to the C-terminus of SEQ ID NO 5 or SEQ ID NO: 6.” Id. at 70:42–44. In claim 1, “the amino acid spacer is selected from SEQ ID NO: 3 or SEQ ID NO: 11.” Id. at 70:38–39.” slip op. at 5

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

    “The Petition fails to explain how, in spite of that difference, the “heavy chain” fusion protein depicted in Bedi’s Figure 3 anticipates claim 1. Pet. 17, 19. On that point, the Petition states that Bedi’s Figure 3 depicts a “construct comprising” the requisite components of the invention, but does not explain why Bedi’s disclosure of a lysine residue, on the C-terminus of the heavy chain sequence, teaches the specific fusion protein recited in claim 1. Id. at 19; see id. at 17 (admitting that Bedi’s heavy chain sequence includes a lysine residue, and that the addition of that residue distinguishes Bedi’s fusion protein from the fusion protein of claim 1); Prelim. Resp. 16– 19. We agree with Patent Owner that the Petition does not address adequately the differences between the “heavy chain” fusion protein depicted in Bedi’s Figure 3 and the claimed invention. Id. at 18. Nor does the Petition address adequately how Bedi’s Figure 3 depicts a fusion protein wherein the immunomodulating moiety “is attached via the amino acid spacer to the C-terminus of” the light chain sequence, specified in claim 1 as SEQ ID NO: 6. Ex. 1001, 70:43–44. We agree with Petitioner that Bedi depicts the same light chain sequence (identified as SEQ ID NO: 71 in Figure 3) as SEQ ID NO: 6 in claim 1. Ex. 1003, Fig. 3. The Petition, however, lacks supported analysis explaining how or why a person of ordinary skill in the art would understand Bedi to disclose in Figure 3 a fusion protein in which the immunomodulating moiety is attached via the amino acid spacer to the “light chain” sequence identified as SEQ ID NO: 71 in Bedi. Pet. 19 (arguing, without any evidentiary support, that Figure 3 depicts “attaching to anti-EGFR1 heavy or light chain (SEQ ID NO: 2 or 71, respectively)”). That attachment is not depicted in Figure 3, and the Petition directs us to no disclosure supporting the view that an ordinary artisan would have understood Figure 3 to illustrate an alternative fusion protein in which the immunomodulating moiety is attached via the amino acid spacer sequence to the C-terminus of the light chain sequence. “[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.” Net MoneyIN, Inc., 545 F.3d at 1371. On this record, we determine that the Petition does not direct us to information sufficient to show that Bedi anticipates claim 1.” slip op. at 6

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

    “Petitioner’s obviousness challenge is interlaced with unsupported factual contentions. Pet. 20–29. The Petition rests on bare argument to establish how two asserted background references (Ex. 1007 and Ex. 1008) would have informed the understanding of an ordinary artisan’s reading of Bedi. Pet. 24–27. A lack of evidence also undermines Petitioner’s attempt to explain why “[o]ne of skill in the art would have been motivated to take the teachings of Bedi and apply them to constructing a fusion protein” according to claim 1 (id. at 27), “wherein SEQ ID NO: 4 is attached via the amino acid spacer to the C-terminus of SEQ ID NO 5 or SEQ ID NO: 6.” Ex. 1001, 70:42–44. The Petition, moreover, directs us to no support for the argument that “one of ordinary skill in the art would appreciate that the Fox3+CD25+CD4 Tregs described in (Ex. 1007 and 1008) will inherently express EGFR under inflammatory conditions, and that EGFR-positive Treg cells are more immunosuppressive than EGFR-negative Treg cells.” Pet. 27. Compounding that evidentiary deficit, the Petition advances bare attorney argument that “one so skilled would be motivated to use the EGFR targeting moiety of Bedi, to target the most immunosuppressive Treg populations set forth in Bedi and” a background reference. Id.” slip op. at 8

  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,815,247

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.