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

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

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

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

  • Expert testimonyOther

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

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

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

  Patent outcomesUS 9,283,239 unpatentable
  § 112 disclosure
  Patents in suitUS 9,283,239
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01413 · APJ Christopher G Paulraj · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

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

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

  Patent outcomesUS 9,034,376 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 9,034,376
• Steadymed Ltd. v. United Therapeutics CorporationAll claims unpatentable
  PTAB · Mar 31, 2017 · IPR2016-00006 · APJ Jacqueline T Harlow · IPR · Final written decision

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

  RulingsFinal written decision

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

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

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

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

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

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

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

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

  Patent outcomesUS 8,497,393 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,497,393
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision

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

  RulingsFinal written decision

  • BurdenNot shown unpatentable

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

  • ExcludeMotion to exclude, deniedMixed

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

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

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

  • Expert testimonyPetitioner expert discountedDecided for patent owner

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

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

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

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

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

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

    “under 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). “Because there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).” slip op. at 14

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

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

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

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

  Patent outcomesUS 8,618,135 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,618,135
• Adlens USA, Inc. / Adlens, Ltd. v. Superfocus Holdings LLC, Superfocus, LLC, Insolvency Services Group, Inc., And Dr. Stephen KurtinAll claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01821 · APJ Elizabeth M Roesel · IPR · Final written decision

  Claims 1–12 and 14–17 are unpatentable as obvious over Kurtin ’532 and Kurtin ’629 in view of Gordon and/or Cronin; anticipation by Cronin was not shown for claims 3–12 and 14–17.

  RulingsFinal written decision

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

    “their broadest reasonable interpretation in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, we generally give claim terms their ordinary and customary meaning, as understood by a person of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). “Absent claim language carrying a narrow meaning, the PTO should only limit the claim based on the specification . . . when [it] expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). “Although an inventor is indeed free to define the specific terms used to describe his or her invention, this must be done with reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We construe claim terms only to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner

    “Our reviewing court instructs that “merely because an element does not include the word ‘means’ does not automatically prevent that element from being construed as a means-plus-function element.” Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc) (quoting Cole v. Kimberly-Clark Corp., 102 F.3d 524, 531 (Fed.Cir.1996)). “Generic terms such as ‘mechanism,’ ‘element,’ ‘device,’ and other nonce words that reflect nothing more than verbal constructs may be used in a claim in a manner that is tantamount to using the word ‘means’ because they ‘typically do not connote sufficiently definite structure’ and therefore may invoke § 112, para. 6.” Id. at 1350. We agree with Patent Owner that the terms, “adjustable element” (claim 3) and “controllable spacing member” (claim 15), should be construed as means-plus-function terms. The words “element” and “member” are the same as or similar to the words the Federal Circuit indicated are “tantamount to using the word ‘means.’” Williamson, 792 F.3d at 1350. Dr. Savidis agrees that the terms, “adjustable element” and “controllable spacing member,” do not define a particular structure. Ex. 2003, 76:4–21, 77:1–7, 80:8–17. Accordingly, we construe these terms in accordance with 35 U.S.C. § 112 ¶ 6. Construing a means-plus-function claim term is a two-step process. We first identify the claimed function, and then we determine what structure disclosed in the specification corresponds to the claimed function. Williamson, 792 F.3d at 1351; In re Donaldson Co., 16 F.3d 1189, 1195 (Fed. Cir. 1994) (en banc).” slip op. at 9

  • Skill levelSkill level board ownDecided for patent owner

    “B. Person of Ordinary Skill in the Art We determine that a person of ordinary skill in the art would have an undergraduate degree in mechanical engineering or equivalent education and one to two years of experience with optics. Our determination is supported by the testimony of Dr. Plummer (Ex. 2002 ¶ 49), as well as the testimony of Dr. Savidis (Ex. 2003, 66:24–67:7, 67:16–20, 69:14–20). We also rely on Petitioner’s asserted references as establishing the level of skill in the art at the relevant time. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed

    “Dr. Plummer testifies that “assembly of Gordon’s spectacles would have to be performed by a skilled technician.” Ex. 2002 ¶ 165 (emphasis added). That testimony does not persuasively support Patent Owner’s argument, PO Resp. 45, that Gordon’s adjustment can only be performed by a skilled technician. To the extent that Dr. Plummer’s testimony could be read to support Patent Owner’s argument, we give greater weight to Dr. Savidis’ testimony, which is consistent with Gordon’s disclosure of an adjustment that can be performed “quickly and readily.” Ex. 1013, 1:14, 1:18.” slip op. at 21

  Patent outcomesUS 8,967,797 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,967,797
• 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
• Biomarin Pharmaceutical Inc. v. Duke UniversityAll claims unpatentable
  PTAB · Feb 23, 2015 · IPR2013-00535 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–9, 11, 12, 15, and 18–21 are unpatentable: van Bree ’410 anticipates claims 1–9, 12, 15, and 18–21, and the cited combinations render the challenged claims obvious.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedMixed

    “As discussed above, however, we consider Mr. Green’s Declaration when analyzing Patent Owner’s contentions regarding objective evidence of non-obviousness. Petitioner argues that we should exclude this Declaration because: (1) it “assumes that Myozyme and Lumizyme are the same product described and claimed” in the ’712 patent; (2) Mr. Green has no “firsthand knowledge of the chemical identity” of Myozyme and Lumizyme or whether the method clamed in the ’712 patent is used to make Myozyme and Lumizyme; (3) “Mr. Green testified that he did not know whether the cell line that was the subject of the 1996 Assignment Agreement . . . (Ex 2070) was the same cell line used by Genzyme to create Myozyme and Lumizyme”; and (4) paragraphs 16–18 and 47–49 of Mr. Phillip’s Declaration mention a 2000 “Agreement” that is not of record in this proceeding. Paper 73, 4–8 (citing Federal Rules of Evidence 702 and 703). We have reviewed the cited portions of the testimony provided by Mr. Green and see no basis on which they would warrant the extreme remedy of exclusion. Patent Owner’s above-mentioned contentions go to the weight and sufficiency of Mr. Green’s testimony, rather than its admissibility. We are capable of discerning from the testimony, and the evidence presented, whether the witness’ testimony should be entitled to any weight, either as a whole or with regard to specific issues. We deny Petitioner’s Motion to Exclude in relation to the Declaration of Mr. Philip Green (Ex. 2021).” slip op. at 41

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “We agree that Patent Owner’s proposed claim construction is the broadest reasonable reading in view of the Specification and language in claim 9 itself. We clarify, however, that claim 1, upon which claim 9 depends, recites a method comprising administering hGAA. Neither claim 1 nor claim 9 precludes administering a non-precursor form of hGAA or rhGAA, even if claim 9 requires administering a precursor of recombinant hGAA that has been produced in CHO cell cultures. Claims 1 and 9 encompass administering both precursor and non-precursor forms at the same time, and are not limited to administering exclusively a precursor form and no other form. 3. “Bimonthly” administration interval Patent Owner proposes that the term “bimonthly” in claim 11 means “every other week.” PO Resp. 15, 25–26. Petitioner does not propose an alternative claim construction in its Reply. Reply 5–6. We agree that Patent Owner’s proposed claim construction is the broadest reasonable reading of the term in view of the Specification. See, e.g., Ex. 1001, 1:52–2:13 (describing administration “monthly, bimonthly, weekly, twice weekly, daily”).” slip op. at 8

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “We agree with Patent Owner. While van Bree ’410 describes administering hGAA produced in CHO cells to GSD-II patients “once, twice or three times weekly” for the reasons discussed above, the reference does not describe administering hGAA less frequently except in Example 5, which describes administering hGAA to healthy volunteers. Ex. 1005, 14:12–55. Petitioner has not established by a preponderance of the evidence that van Bree ’410 expressly or inherently describes treating GSD-II in a human by administering rhGAA bimonthly, as required in claim 11.” slip op. at 19

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

    “We find that Reuser ’771 suggests using, in its methods, rhGAA from sources other than milk of transgenic mice, including as produced in CHO cell culture. For example, Reuser teaches that “restoration of the endogenous acid α- glucosidase activity by acid α-glucosidase isolated from mouse milk was as efficient as restoration by acid α-glucosidase purified from bovine testis, human urine and medium of transfected CHO cells.” Ex 1004, 28:10–18. In addition, Van Hove 1997 describes methods for making large quantities of rhGAA in CHO cells, and at least suggests using such rhGAA for the treatment of Pompe disease. Ex. 1007, 613–614. In light of disclosures in the two references, both discussing rhGAA produced in CHO cells and methods of treating Pompe disease, we find that one would have had reason to combine teachings of those references. Patent Owner acknowledges that the above-mentioned statement in Reuser ’771 (PO Resp. 31; Ex 1004, 28:10–18), but contends that an ordinary artisan reading the reference would not have thought that hGAA from transgenic mice and CHO cells shared similarities because Reuser ’771 “cites only previous in vitro studies,” and no in vivo data, in support. PO Resp. 31–32. That contention assumes, however, that one would have understood that statements in Reuser ’771, indicating that hGAA from both sources (transgenic mice and CHO cells) would work to restore endogenous GAA activity, were affirmatively incorrect in the absence of in vivo data. A showing of obviousness here does not require in vivo data as “proof” that an otherwise clear statement in Reuser ’771 is correct, when it is reasonably based on in vitro studies and other information discussed in the reference. As the Supreme Court has explained: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 402–403 (2007). Here, Reuser ’771 identified rhGAA produced in CHO cells, in particular, and, especially in view of Van Hove 1997, provided “good reason to pursue the known options within his or her technical grasp” using such rhGAA for the treatment of Pompe disease, as taught by Reuser ’771, including at the administration doses and intervals disclosed in Reuser ’771.” slip op. at 26

  Patent outcomesUS 7,056,712 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,056,712
• Ariosa Diagnostics v. Isis Innovation LimitedSome claims unpatentable
  PTAB · Sep 2, 2014 · IPR2012-00022 · APJ Lora M Green · IPR · Final written decision

  Claims 1, 2, 4, 5, 8, 19, 20, 24, and 25 are unpatentable as anticipated by Kazakov; claims 3, 12, 13, 15, 18, 21, and 22 were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “party in interest filed a civil action challenging the validity of a claim of the patent” in § 315(a)(1) of the statute. Paper 20, 4. Under Isis’s interpretation of the statute, “filing” extends beyond the commencement of the civil action and includes raising the affirmative defense of invalidity. Id. We looked to the Federal Rules of Civil Procedure as a guide to interpreting the plain meaning of the statute. Id. We noted that Rule 2 of the Federal Rules of Civil Procedure9 states that “[t]here is one form of action—the civil action,” and Rule 3 states that “[a] civil action is commenced by filing a complaint with the court.” Id. at 5. Defenses are raised in answer to the complaint or in answer to a counterclaim. Id. (citing Fed. R. Civ. P. 12). We concluded, therefore, that when the statute refers to filing a civil action, it refers to filing a complaint with the court to commence the civil action. Id.; see, e.g., Baldwin Cnty. Welcome Ctr. v. Brown, 466 U.S. 147, 149 (1984) (citing Fed. R. Civ. P. 3” slip op. at 11

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

    “Specifically, the panel in that case looked to the Federal Rules of Civil Procedure in making its determination. Id. at 15. As to the requirement of service, the panel noted that the infringement suit was voluntarily dismissed without prejudice under Fed. R. Civ. P. 41(a). Id. The panel noted further that the Court of Appeals for the Federal Circuit has consistently interpreted the effect of such dismissals as leaving the parties as though the action had never been brought. Id. (citing Graves v. Principi, 294 F.3d 1350, 1356 (Fed. Cir. 2002) (“The dismissal of an action without prejudice leaves the parties as though the action had never been brought”); Bonneville Associates, Ltd. Partnership v. Baram, 165 F.3d 1360, 1364 (Fed. Cir. 1999) (“The rule in the federal courts is that ‘[t]he effect of a voluntary dismissal without prejudice pursuant to Rule 41(a) is to render the proceedings a nullity and leave the parties as if the action had never been brought.’”) (citations and internal quotes omitted.)); Accord, Wright, Miller, Kane, and Marcus, 9 Federal Prac. & Proc. Civ. § 2367 (3d. ed.) (“[A]s numerous federal courts have made clear, a voluntary dismissal without prejudice under Rule 41(a) leaves the situation as if the action never had been filed.”) (footnote omitted). As in the Macauto case, we agreed that the dismissal without prejudice leaves the parties as if the action had never been brought, and concluded that Ariosa was not barred from filing its Petition in IPR2013- 00250 under 35 U.S.C. § 315(b). IPR2013-00250, Paper 26, 3. As a result, we did not address Isis’s arguments (IPR2013-00250, Prelim. Res. 44–46) regarding joinder in the context of the bar under § 315(b). Id.” slip op. at 17

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedDecided for petitioner

    “While the plain language of the statute mentions joinder of “a party” and does not specifically articulate the joinder of issues, it states that “any person who properly files a petition under section 311” may be joined at the Director’s discretion. Thus, there does not appear to be any language in the statute directly prohibiting the joinder of issues by the same party. The legislative history of this section provides little guidance as to the scope of this statutory section. As the final Committee Report noted, under §§ 315(c) and 325(c), “[t]he Director may allow other petitioners to join an inter partes or post-grant review.” See H.R. Rep. No. 112-98, pt.1, at 76 (2011). During the Senate’s March 2011 debates on the AIA, Senator Kyl stated that the USPTO expected to allow liberal joinder of reviews: The Office anticipates that joinder will be allowed as of right— if an inter partes review is instituted on the basis of a petition, for example, a party that files an identical petition will be joined to that proceeding, and thus allowed to file its own briefs and make its own arguments. If a party seeking joinder also presents additional challenges to validity that satisfy the threshold for instituting a proceeding, the Office will either join that party and its new arguments to the existing proceeding, or institute a second proceeding for the patent. 157 Cong. Rec. S 1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl). Senator Kyl, thus, contemplated the joinder of issues as well as the joinder of parties. In addition to noting that §§ 315(c) and 325(c) give the USPTO” slip op. at 19

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

    “the amplification step in the Institution Decision. Both the amplification step and the detecting step of claim 1, however, use very similar language. That is, the amplifying step requires “amplifying a paternally inherited nucleic acid from the serum or plasma sample,” and the detecting step requires “detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.” Applicants could have added “only,” such that the claim read as “only detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample,” but they chose not to do so. See, e.g., Aria, 726 F.3d at 1301 (noting as to the claim limitation of “paternally inherited nucleic acid” that during prosecution before the examiner the inventors could have limited the claims to those nucleic acids that were known in advance to come from the father). Thus, when the “detecting” step is construed in conjunction with the use of “comprising” as the transitional phrase, there is nothing in the language of claim 1 that limits the detecting step to also determining or identifying the detected nucleic acid as being of fetal origin and not being possessed by the pregnant female.” slip op. at 25

  Patent outcomesUS 6,258,540 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,258,540
• International Flavors & Fragrances Inc. v. The United States Of America, As Represented By The Secretary Of AgricultureOther
  PTAB · May 20, 2014 · IPR2013-00124 · APJ Lora M Green · IPR · Final written decision

  The Board granted cancellation of claims 1-26 and allowed substitute claims 27-44, but denied substitute claim 45 as unpatentable over Behan.

  RulingsFinal written decision

  • ScopeMotion to amend, grantedGranted

    “patent claims. 35 U.S.C. § 316(d)(3); 37 C.F.R. § 42.121(a)(2)(ii).” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner

    “partes review must set forth “[t]he support in the original disclosure of the patent for each claim that is added or amended.”” slip op. at 10

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

    “In order to establish a prima facie case of obviousness based on structural similarity, the prior art must provide a reason to make the claimed compound, and there must also be “„adequate support in the prior art‟ for the 7 P.E.A. Teal et al., (Z)-11-Hexadecen-1-ol: A Behavioral Modifying Chemical Present in the Pheromone Gland of Female Heliothis Zea (Lepidoptera:Noctuidae), 116 CAN. ENTOMOLOGY 777-79 (1984). Ex. 2003. 8 Yih-Shen Hwang et al., Structure-Activity Relationship of Unsaturated Fatty Acids as Mosquito Ovipositional Repellents, 10 J. OF CHEM. ECOLOGY 145-51 (1984). Ex. 2004. change in structure.” Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007) (quoting In re Grabiak, 769 F.2d 729, 731-32 (Fed. Cir. 1985)). The United States Court of Appeals for the Federal Circuit noted that the test for obviousness of a compound based on structural similarity is in accordance with the legal principles enunciated by the Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), specifically, that it is 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‟ in an obviousness determination.” Takeda, 492 F.3d at 1356-57 (quoting KSR, 550 U.S. at 418). Thus, “in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.” Takeda, 492 F.3d at 1357.” slip op. at 14

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

    “We acknowledge that McMahon and the Zhang Declaration are evidence that the ordinary artisan would not have had a reasonable expectation that, because a compound is known to repel mosquitoes, such as Aedes aegypti, the compound would also repel ticks, such as Amblyomma variegatum. Claim 45, however, encompasses the use of isolongifolanone when R1 is a hydrogen atom and R2 is an oxygen atom, which is the same compound specifically taught by Behan. See Pet. 7-8 (showing the structure of isolongifolanone, and discussing how it is encompassed by the chemical formula set forth in claim 1). As discussed above, Behan teaches the use of isolongifolanone to repel mosquitoes or cockroaches. Patent Owner provides no evidence that ticks and mites would not be present on the same objects or areas where mosquitoes and cockroaches are found, which are the insects addressed by Behan. Thus, by applying the isolongifolanone taught by Behan to an object or airspace for the purpose of repelling mosquitoes or cockroaches, one would also inherently repel ticks and mites. “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); see also Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005) (noting that the realization of a new benefit of an old process does not render that process patentable); Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating in the context of a claimed process that was drawn to the same use comprising the same steps of the prior art, “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). We, therefore, conclude that the preponderance of the evidence does not support the patentability of proposed claim 45.” slip op. at 17

  § 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 7,579,016

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.