• Medtronic, Inc. And Medtronic Vascular, Inc. v. Teleflex Life Sciences LimitedSome claims unpatentable
  PTAB · Feb 23, 2022 · IPR2020-01343 · APJ James A Tartal · IPR · Final written decision

  Claims 52 and 53 are unpatentable as anticipated by Ressemann; the other challenged claims were not shown unpatentable because Itou is not prior art.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “Documents are authenticated by evidence “sufficient to support a finding that the item is what the proponent claims it is.” Fed. R. Evid. 901(a); see Fox Factory v. SRAM, LLC, IPR2016-01876, Paper 59 at 63 (PTAB Apr. 2, 2018) (quoting same). “Authenticity is, therefore, not an especially high hurdle for a party to overcome.” Fox Factory, Paper 59 at 63 (citing United States v. Patterson, 277 F.3d 709, 713 (4th Cir. 2002)). We determine that Exhibit 2024 has been authenticated under the low bar required under Federal Rule of Evidence 901 based on the evidence provided by Petitioner. See Mot. Opp. 2–11. In addition, Petitioner’s arguments go to the weight of the evidence and not its admissibility. Accordingly, we deny Petitioner’s Motion to Exclude. We note, however, that even if we were to exclude Exhibit 2024, it would not change the outcome or our general analysis of this case.” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person of ordinary skill in the art at the time of the invention would have been either: (1) a medical doctor who would have had “(a) a medical degree; (b) completed a coronary intervention cardiologist;” or (2) an engineer who would have had “(a) an undergraduate degree in engineering, such as mechanical or biomedical engineering; and (b) at least three years of experience designing medical devices, including catheters or catheter-deployable devices.” Pet. 13–14. Additionally, Petitioner contends “[e]xtensive experience and technical training might substitute for education, and advanced degrees might substitute for experience.” Id. at 14. Further, according to Petitioner, a person of ordinary skill in the art “with a medical degree” and a person of ordinary skill in the art “with an engineering degree” may have had access to each other. Id. (citing Ex. 1005 ¶ 31; Ex. 1042 ¶¶ 18–19). Patent Owner does not dispute Petitioner’s proposed level of ordinary skill. PO Resp. 5. We adopt Petitioner’s proposed level of ordinary skill in the art as it is undisputed and consistent with the level of skill reflected in the prior art and the specification of the ’116 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 17

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

    “Petitioner proposes the following constructions: (1) “substantially rigid” as “rigid enough to allow the device to be advanced within the guide catheter,” (2) “side opening” needs no construction and should be given its plain and ordinary meaning, (3) “lumen” as “the cavity of a tube,” and (4) “flexural modulus” as “[a] measure of resistance . . . to bending.” 7 Patent Owner argues that Dr. Hillstead does not meet the definition of a person of ordinary skill in the art because he lacks a four-year undergraduate degree in engineering. PO Resp. 5 n.1 (citing, e.g., Ex. 2137, 462:8–13). As noted above, however, it is undisputed that “[e]xtensive experience and technical training might substitute for education.” Pet. 14. Patent Owner does not address Dr. Hillstead’s significant professional experience, which we find sufficient to show he is qualified to opine on the issues in this proceeding from the perspective of a person of ordinary skill in the art. See Ex. 1043 (curriculum vitae of Dr. Hillstead). does not dispute at this stage of the proceeding Petitioner’s proposed construction of these terms. See generally PO Resp. In view of the issues we address below, we determine it is not necessary to address the express interpretation of any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 19

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

    “Ressemann. Pet. 23–31. Petitioner provides a detailed explanation of how it contends Ressemann discloses each of the limitations of claims 52 and 53. Id. In particular, Petitioner explains how Ressemann’s disclosures of the use of features including guide catheter 160, evacuation sheath assembly 100, intermediate shaft portion 120, distal shaft portion 130, lumen 140, and stent delivery system 194 correspond to the recited methods of claims 52 and 53. Id. Petitioner’s contentions are supported by Dr. Brecker and Dr. Hillstead. Ex. 1005 ¶¶ 164–174; Ex. 1042 ¶¶ 36–39, 58–62. Patent Owner does not dispute that claims 52 and 53 are anticipated by Ressemann. See generally PO Resp; PO Sur-reply; see also Pet. Reply 2 (Petitioner arguing that Patent Owner did not dispute that Ressemann anticipates claims 52 and 53). After reviewing the record, we find Petitioner shows by a preponderance of the evidence that Ressemann discloses each limitations (Pet. 23–31) as our own findings. Accordingly, Petitioner shows by a preponderance of the evidence that Ressemann anticipates claims 52 and 53 of the ’116 patent.” slip op. at 26

  Patent outcomesUS RE46,116 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
• Collegium Pharmaceutical, Inc. v. Purdue Pharma L.P., Purdue Pharmaceuticals L.P., And The P.F. Laboratories Inc.All claims unpatentable
  PTAB · Nov 19, 2021 · PGR2018-00048 · APJ Devon Zastrow Newman · PGR · Final written decision

  Claims 1–17 are unpatentable for lack of written description and anticipation by the ’943 Publication; indefiniteness and lack of enablement were not shown.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “We are not persuaded that exclusion of the cited portions of Dr. Chambliss’ testimony or Exhibits 1073, 1074, 1075, 1082, 1083, 1084, 1085, 1086, 1088, and 1090 is warranted. While the parties disagree on the merits of Dr. Chambliss’ testimony as to whether PGGs were known to be gelling agents by persons of ordinary skill in the art at the time of the Priority Applications, Patent Owner does not persuade us that Dr. Chambliss fails to support his testimony with any reasonable logical or scientific basis. The exhibits that Patent Owner seeks to exclude, which include a patent, technical references, and a journal article, are relevant to the inquiry Dr. Chambliss performed in forming his opinion. We therefore do not see a basis for exclusion under FRE 702/703 or 37 C.F.R. § 42.64(c). Moreover, we find this evidence both admissible and relevant as it concerns a fundamental issue for our patentability analysis. Thus, we decline to exclude the evidence under FRE 401 or 402.” slip op. at 12

  • Skill levelSkill level petitioner adoptedOther

    “would have possessed “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, and/or pharmacology and a number of years of industry training or experience in one or more of those fields.” Pet. 21 (citing Ex. 1002 ¶ 82). Petitioner further proposes that “[i]f the degree is a Ph.D[.], then the required industry experience need not be significant, e.g., two years or more, but if the technical degree is a B.S. or M.S., then the industry experience would be more significant, e.g., five years or more.” Id. We preliminarily adopted Petitioner’s definition of a POSA’s skill level in our Institution Decision as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Neither Patent Owner nor Petitioner addresses the level of ordinary skill in the art in the post-institution briefing. We continue to adopt Petitioner’s proposed skill level for a POSA herein and have also taken into account the level of skill reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Applying this level of skill, we find that Dr. Chambliss and Dr. Constantinides are qualified to provide opinions as to the perspective and knowledge of a POSA. See Ex. 1002 ¶¶ 81–83; Ex. 2030 ¶¶ 58–63.” slip op. at 8

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

    “We agree with Patent Owner that the challenged claims recite methods of making formulations using recited features and ingredients. In addition, as we stated in our Decision on Institution, “[t]he claims define abuse deterrence in terms of when the dosage form is ‘subjected to t[a]mpering comprising heating at a temperature greater than about 45° C.’” Inst. Dec. 19 (quoting Ex. 1001, 41:50–52). Additionally, the claims and specification identify specific ingredients that can purportedly help achieve this abuse deterrence functionality. Id. Given these conclusions, further construction of “abuse deterrent,” which both parties generally agree relates to methods of making the drug dosage form less likely to be abused, is not necessary to resolve the issues before us.” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable

    “Notwithstanding these individual teachings, we find that the specification fails to demonstrate that the inventors of the ’961 patent possessed a dosage form comprising a combination of the recited components that also satisfied the recited functionality. We are persuaded that the specification fails to provide sufficient guidance that would have led the POSA to create the recited dosage form. See Fujikawan 93 F.3d at 1571; In re Ruschig, 379 F.2d 990, 995 (CCPA 1967). Rather, “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.” Ruschig, 379 F.2d at 995.” slip op. at 34

  Patent outcomesUS 9,693,961 unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites Nautilus
  Patents in suitUS 9,693,961
• Foundation Medicine, Inc. v. Caris Mpi, Inc.All claims unpatentable
  PTAB · May 28, 2020 · IPR2019-00171 · APJ Kristi L R Sawert · IPR · Final written decision

  Claims 1–14 are unpatentable as obvious over Lu and Illumina; the Board did not reach the additional grounds involving Muraca or McDoniels-Silvers.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on our consideration of the full record, we maintain our determination that a person with a Ph.D. in genetics, molecular biology, experience in an academic or industry setting, including at least two to three years of research experience in the field of cancer genomics, would satisfy the definition of an ordinarily skilled artisan in this proceeding. We further find that, although the ordinarily skilled artisan may have a medical degree instead of, or in addition to, a Ph.D., that artisan need not be a practicing oncologist with experience treating cancer patients. In determining the level of ordinary skill, various factors may be considered, including “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). These factors are “merely a guide,” and the weight or significance ascribed to each depends on the particular case. Id. In this particular case, we find that the factors, overall, support Petitioner’s definition of an ordinarily skilled artisan.” slip op. at 13

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

    “Marion Roussel, Inc., 457 F.3d 1293, 1301 (Fed. Cir. 2006) (“[C]laim construction must begin with the words of the claims themselves.”). As explained above, the parties dispute whether claim 1 requires that the system is a “cancer-lineage independent system”—that is, does not encompass the allegedly “cancer-lineage dependent” systems of the prior art. For the reasons provided below, we determine that the broadest reasonable interpretation of claim 1 does not require the system to be “cancer-lineage independent.” We see nothing explicit in the plain language of claim 1 that requires the claimed system to be a “cancer-lineage independent” system. See Ex. 1001, 17:5–35. The written description of the ’365 patent uses phrases such as “independent of disease lineage diagnosis,” id. at 2:34–35, 13:20– 21, and “not single disease restricted,” id. at 2:47–49, 13:21–22, to convey the concept of identifying a therapeutic agent independently of cancer lineage. But claim 1 fails to explicitly recite such language relating to to a system that determines the molecular profile for an individual with a cancer and generates a report identifying at least one therapeutic agent8 based on that individual’s molecular profile. See Ex. 1001, 17:5–35.” slip op. at 20

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

    “reason to combine the teachings of Lu and Illumina, with a reasonable expectation of success, based on the teachings of the art, and based on the Lu and Illumina references themselves. Pet. 49–55. In our Institution Decision, we determined that Petitioner had shown sufficiently for modify Lu’s system with Illumina’s DASL assay. Inst. Dec. 17–19. Upon review of the complete record, we affirm our initial determination. We find that the preponderance of record evidence supports Petitioner’s argument that an ordinarily skilled artisan would have regarded RT-PCR assays as old technology, readily replaced by the more advanced DASL assay. Pet. 52– 53; Ex. 1002 ¶ 118–119. We also rely on and credit Dr. Spellman’s testimony that the DASL assay was “capable of investigating a substantially larger number of molecular targets simultaneously than RT-PCR.” Ex. 1002 ¶ 119; see also Ex. 1047, 2386; Ex. 1053, 586; Pet. 52–55. In view of this evidence, we find that a preponderance of the evidence supports that an ordinary artisan would have been motivated to modify Lu’s system with Illumina’s DASL assay. We note that, during oral hearing, counsel for Patent Owner conceded that an ordinarily skilled artisan would have been motivated to use Illumina’s DASL assay in Lu’s system: JUDGE: . . . [W]hy wouldn’t somebody skilled in the art just replace the chip, that Lu talks about, with a DASL assay chip? . . . MR. SINGER: . . . I think they have the better of the argument, there, to be perfectly blunt, that people would go to something that was a commercial product and use it. So, I will acknowledge that . . . .” slip op. at 45

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for patent owner

    “and praise very little to no weight in our obviousness analysis. “For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (quotation and emphasis omitted); see also Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (“In order to accord substantial weight to secondary considerations in an obviousness analysis, the evidence of secondary considerations must have a nexus to the claims, i.e., there must be a legally and factually sufficient connection between the evidence and the patented invention.” (quotation omitted)). Here, Patent Owner also does not allege (or even mention) a “nexus” in its Response. See PO Resp. 14–24, 48–50. And this is not a case where we apply a presumption of nexus, because Patent Owner has not shown or alleged a specific product that is the invention disclosed and claimed in the ’365 patent. Id.; see also WBIP, 829 F.3d at 1329 (setting forth circumstances in which the presumption of nexus applies); Fox Factory, 994 F.3d at 1373 (explaining that a nexus is presumed when “the patentee shows that the asserted objective evidence is tied to a specific product and that product ‘embodies the claimed features, and is coextensive with them.’” (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018))).” slip op. at 48

  Patent outcomesUS 9,383,365 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,383,365
• Foundation Medicine, Inc. v. Caris Mpi, Inc.All claims unpatentable
  PTAB · May 28, 2020 · IPR2019-00164 · APJ Kristi L R Sawert · IPR · Final written decision

  Claims 1–14 are unpatentable as obvious over Lu and Illumina; the Board did not reach the additional grounds.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Based on our consideration of the full record, we maintain our determination that a person with a Ph.D. in genetics, molecular biology, bioinformatics, or a related field, and at least five years of research experience in an academic or industry setting, including at least two to three years of research experience in the field of cancer genomics, would satisfy the definition of an ordinarily skilled artisan in this proceeding. We further instead of, or in addition to, a Ph.D., that artisan need not be a practicing oncologist with experience treating cancer patients. In determining the level of ordinary skill, various factors may be considered, including “(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). These factors are “merely a guide,” and the weight or significance ascribed to each depends on the particular case. Id. In this particular case, we find that the factors, overall, support Petitioner’s definition of an ordinarily skilled artisan.” slip op. at 13

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

    “Marion Roussel, Inc., 457 F.3d 1293, 1301 (Fed. Cir. 2006) (“[C]laim construction must begin with the words of the claims themselves.”). As explained above, the parties dispute whether claim 1 requires that the system is a “cancer-lineage independent system”—that is, does not encompass the allegedly “cancer-lineage dependent” systems of the prior art. For the reasons provided below, we determine that the broadest reasonable interpretation of claim 1 does not require the system to be “cancer-lineage independent.” We see nothing explicit in the plain language of claim 1 that requires the claimed system to be a “cancer-lineage independent” system. See Ex. 1001, 16:64–17:27. The written description of the ’350 patent uses phrases such as “independent of disease lineage diagnosis,” id. at 2:32–33, 13:12–16, and “not single disease restricted,” id. at 2:45–47, 13:12–16, to convey the concept of identifying a therapeutic agent independently of cancer lineage. But claim 1 fails to explicitly recite such language relating to cancer lineage. Instead, the plain words of the claim are broadly addressed to a system that determines the molecular profile for an individual with a cancer and generates a report identifying at least one therapeutic” slip op. at 20

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

    “reason to combine the teachings of Lu and Illumina, with a reasonable expectation of success, based on the teachings of the art, and based on the Lu and Illumina references themselves. Pet. 48–58. In our Institution Decision, we determined that Petitioner had shown sufficiently for institution that an ordinarily skilled artisan would have been motivated to modify Lu’s system with Illumina’s DASL assay. Inst. Dec. 27–28. Upon review of the complete record, we affirm our initial determination. We find that the preponderance of record evidence supports Petitioner’s argument that an ordinarily skilled artisan would have regarded RT-PCR assays as old technology, readily replaced by the more advanced DASL assay. Pet. 51– 58; Ex. 1002 ¶ 120. We also rely on and credit Dr. Spellman’s testimony number of molecular targets simultaneously than RT-PCR.” Ex. 1002 ¶ 120; see also Ex. 1047, 2386; Ex. 1053, 586; Pet. 52–53. In view of this evidence, we find that a preponderance of the evidence supports that an ordinary artisan would have been motivated to modify Lu’s system with Illumina’s DASL assay. We note that, during oral hearing, counsel for Patent Owner conceded that an ordinarily skilled artisan would have been motivated to use Illumina’s DASL assay in Lu’s system: JUDGE: . . . [W]hy wouldn’t somebody skilled in the art just replace the chip, that Lu talks about, with a DASL assay chip? . . . MR. SINGER: . . . I think they have the better of the argument, there, to be perfectly blunt, that people would go to something that was a commercial product and use it. So, I will acknowledge that . . . . Tr. 54:15–55:8. b) Reasonable expectation of success We next consider whether Petitioner has shown by a preponderance of the evidence that the skilled artisan would have had a reasonable expectation of success in achieving the method claimed in the ’945 patent. “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). We are persuaded that Petitioner has shown by a preponderance of the evidence that an ordinarily skilled artisan would have had a reasonable expectation of success using Illumina’s DASL assay in Lu’s system, given that the DASL assay was commercially available and recognized in the art Ex. 1002 ¶¶ 183–185; Ex. 1050, 28–29, 31; Ex. 1046, 2; Ex. 1048, 1806; Ex. 1049, 878. We also observe that all the elements of molecular profiling systems were known, and required only ordinary skill to carry out. See Pet. 56–58; see also Ex. 1002 ¶ 68, 186; Ex. 1037, Abstract; Ex. 1055, Abstract; Ex. 1051, 170, 172; Ex. 1032, 166, 169 (Table 2). Patent Owner does not provide specific arguments disputing Petitioner’s position as to reasonable expectation of success. See generally PO Resp.; PO Sur-Reply; see also Reply 21 n.12.” slip op. at 45

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “Here, Patent Owner also does not allege (or even mention) a “nexus” in its Response. See PO Resp. 14–24, 48–50. And this is not a case where we apply a presumption of nexus, because Patent Owner has not shown or alleged a specific product that is the invention disclosed and claimed in the ’350 patent. Id.; see also WBIP, 829 F.3d at 1329 (setting forth circumstances in which the presumption of nexus applies); Fox Factory, 994 F.3d at 1373 (explaining that a nexus is presumed when “the patentee shows that the asserted objective evidence is tied to a specific product and that product ‘embodies the claimed features, and is coextensive with them.’” (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018))). In addition to a lack of nexus to the claimed invention, Patent Owner also fails to provide specific, persuasive evidence of long-felt need beyond a conclusory statement that “Drs. Von Hoff and Penny’s invention fulfilled a long-felt need in the oncology community for improved tools for identifying therapeutic agents for their cancer patients.” PO Resp. 49. This statement falls short of a preponderance of evidence that the claimed invention fulfills a long-felt need.” slip op. at 48

  Patent outcomesUS 8,880,350 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,880,350
• Mylan Pharmaceuticals Inc. / Teva Pharmaceuticals USA, Inc. et al. v. Saint Regis Mohawk Tribe And Allergan, Inc.All claims unpatentable
  PTAB · Sep 27, 2019 · IPR2016-01129 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–20 are unpatentable based on collateral estoppel from the final judgment that materially similar claims were obvious.

  RulingsFinal written decision

  • BurdenFwd all claims unpatentableUnpatentable

    “and 37 C.F.R. § 42.73. Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, Inc., and Akorn Inc. (collectively, “Petitioner”) bears the burden of proving unpatentability of the challenged claims, and that burden of persuasion 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 prove unpatentability by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). For the reasons that follow, we determine that Petitioner has shown, by a preponderance of the evidence, that claims 1–20 of U.S. Patent No. 8,642,556 B2 (Ex. 1001, “the ’556 patent”) are unpatentable.” slip op. at 2

  • ExcludeMotion to exclude, grantedOther

    “Owner opposed (Paper 51) and Petitioner submitted a reply in support of its motion (Paper 58). Petitioner moves to exclude a) Ex. 2008; b) portions of the Declarations of Dr. Sheppard (Ex. 2024) and Dr. Loftsson (Ex. 2025); c) Exhibit 2038, d) portions of Exhibit 2028; and e) Exhibit 2077–2079. Paper 50, 1. Because we do not rely on any of the exhibits or portions of exhibits sought to be excluded by Petitioner to reach the final decision, we dismiss Petitioner’s motion to exclude as moot.” slip op. at 24

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

    “claimed composition and methods in view of Patent Owner’s assertion that the Restasis formulation covered by the claims exhibited unexpected results compared to the prior art, which is the same argument Patent Owner has asserted in this case. Compare Ex. 1167, 34–108, with PO Resp. 21–35. Accordingly, we find that the district court in the prior case, Allergan v. Teva, considered the identical issue before us in this case, i.e., the obviousness of the subject matter in light of Ding ’979, Sall, and Acheampong as well as Patent Owner’s arguments of unexpected results.” slip op. at 19

  Patent outcomesUS 8,642,556 unpatentable
  § 103 obviousness
  Patents in suitUS 8,642,556
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Feb 8, 2018 · IPR2016-01412 · APJ Christopher G Paulraj · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

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

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

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

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

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

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

  Patent outcomesUS 9,034,376 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR
  Patents in suitUS 9,034,376
• Emerson Electric Co. v. Sipco, LLCAll claims unpatentable
  PTAB · Jan 16, 2018 · CBM2016-00095 · APJ Joni Y Chang · CBM · Final written decision

  Claims 1, 7, 9, 16, and 17 are unpatentable under § 101 and § 103(a) over Tymes; unpatentability under § 112, ¶ 1 was not shown.

  RulingsFinal written decision

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

    “Upon consideration of the parties’ contentions, we are not persuaded by Patent Owner’s arguments, as they conflate “power” with “transmission range”—the claim term recites “low-power,” not “low-transmission range.” We agree with Petitioner that Patent Owner’s proposed construction would import improperly a limitation into the claims, and we credit Mr. James T. Geier’s testimony (Ex. 1038 ¶¶ 34−39) as it consistent with the other evidence of record before us. We address below each of Patent Owner’s arguments in turn. First, Patent Owner argues that “the claim language itself indicates that the claimed low-power transceiver transmits low-power signals,” citing the language of claim 2, “wherein the low-power signal comprises a logical IP address.” PO Resp. 12 (citing Ex. 1001, 14:60–61). However, “the low-power signal” does not necessarily require a transceiver to transmit signals having a limited transmission range. Patent Owner does not explain meaningfully, or provide persuasive evidence to show, how a “low-power signal” is necessarily related to the transmission range of a transceiver. Consistent with the plain and ordinary meaning of the term, “a low-power transceiver” refers to a transceiver that consumes less power, e.g., by transmitting and receiving low power signals. Ex. 1038 ¶¶ 34−39.” slip op. at 23

  • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionUnpatentable

    “However, Patent Owner’s arguments are not commensurate in scope with the claims. The purported problems that arose with the development of networks hosting wireless device—unlawful interruption of that data, interference, and contention—are addressed by using an extremely low-power transmitter. Ex. 1001, 5:65−6:11. As discussed above, the challenged claims recite a generic “low-power transceiver,” not an extremely low-power transmitter. Additionally, the alleged problem of transforming data to a different protocol is addressed by an unclaimed feature, as the ’842 patent itself recognizes that the invention is not necessarily limited to certain protocol or requires a protocol conversion. Id. at 13:55−14:5. Moreover, the challenged claims do not requires a protocol conversion or recite a device for converting data from one protocol to a different protocol. Rather, they recite generically a “network of addressable devices.” Patent Owner’s argument that the claims are “directed to an improvement in communication technology between remote devices that are accessible by wireless communication and a central location via a circuit interface” is unavailing. Significantly, the claims are not directed to a new type of transceiver, interface circuit, or controller to establish a communication link between a remote device and the central location. Instead, the claims are directed to transmitting data between locations using conventional or generic computer components. The challenged claims essentially recite a device for communicating information that comprises: (1) a low-power transceiver for transmitting or receiving data; (2) an interface circuit for communicating with a central 33 location; and (3) a controller for establishing a communication link. The Specification confirms that these features were known in the art. Ex. 1001, 5:23–25, 6:62–64 (“As is well known by those skilled in the art, a variety of transducers can perform this functionality adequately.”), 10:13–15 (“[T]he controller 256 may be a general purpose microprocessor or microcontroller.”), 10:21–23 (“The interface 258 within the transceiver 270 is designed to interface with this typical/standard telephone circuitry 263.”), 10:23–26 (“The specific implementation of the circuitry of [interface] 258 will be appreciated by persons skilled in the art and need not be described in detail herein.”). Indeed, the FCC Bulletin also confirms that low-power wireless transmitters were “used virtually everywhere,” noting that “[c]ordless phones, baby monitors, garage door openers, wireless home security systems, keyless automobile entry systems and hundreds of other types of common electronic equipment rely on such transmitters to function.” Ex. 2001, 1. Moreover, the ’842 patent itself recognizes that the communication link between the remote device and central location can be established by initiating a phone call over a telephone line that is part of the public-switched telephone network. Ex. 1001, 2:34−38. There is no dispute that such a communication link was known in the art. Id. at 10:21−26.” slip op. at 33

  • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptUnpatentable

    “38 For the foregoing reasons, we are persuaded that Petitioner has demonstrated sufficiently that claims 1, 7, 9, 16, and 17 of the ’842 patent are directed to a patent-ineligible abstract idea. Whether the challenged claims lack a patent-eligible inventive concept Turning to the second step in the analysis, we look for additional elements that can “transform the nature of the claim” into a patent-eligible application of an abstract idea. That is, we determine whether the claims include an “inventive concept,” i.e., an element or combination of elements sufficient to ensure that the patent in practice amounts to significantly more than a patent on the abstract idea itself. Alice, 134 S. Ct. at 2357. The additional elements must be more than “well-understood, routine, conventional activity.” Mayo, 768 S. Ct. at 1297−98. Here, Petitioner argues that claims 1, 7, 9, 16, and 17 are unpatentable because they are “directed only to an abstract idea with nothing more added than generic computing components and ‘well-understood, routine, conventional activity’ previously performed in the field (both individually and as an ordered combination in the claims).” Pet. 23–24 (citing Mayo, 132 S. Ct. at 1294). According to Petitioner, the challenged claims “recite the concept of establishing a communication route between two points ‘as performed by a generic computer,’ without disclosing any ‘novel or unusual’ improvement to ‘the functioning of the computer itself’ or any ‘advance in computer technology that makes the performance of [routine] functions more effective.” Id. at 24 (citing Alice, 134 S. Ct. at 2358–60). 39” slip op. at 38

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “As Petitioner notes (Pet. 66−68; Ex. 1003 ¶¶ 353−366), Tymes discloses “an improved, low-cost, low-power, data communication network in which a number of remote terminal units are able to send packets of data to a central station, and . . . to receive acknowledge signals and data from the central station.” Ex. 1005, 2:36−56 (emphasis added). Tymes describes that the central station includes a number of base stations connected to a central computer. Id. at 3:21−25. As shown in Figure 1, the network includes base stations 12−14, each of which “is coupled by an RF link to a number of remote units.” Id. at 4:61−5:44. The RF link is used for sending “data packets from the remote terminals to the base stations and return.” Id. at 3:48−51 (emphasis added), 6:66–7:2. In fact, Tymes teaches that the “advantage of this type of RF data link is that a band may be used which does not require site licensing by the F.C.C.” Id. at 3:55−59. Contrary to Patent Owner’s assertion that “low-power” refers to only the remote terminals, Tymes describes a low-power network that includes base stations. As Petitioner also notes (Pet. 66–67, n.38), Tymes teaches an “indoor” limited range network and an RF data link “usable without site licensing under F.C.C. regulations, so that the expense and delays incident to such licensing are eliminated or minimized.” Ex. 1005, 2:36–56. Significantly, Tymes discloses that the optimum frequency is in the 902−928 MHz range 54 for the RF transceivers in the base stations. Id. at 6:66–7:2, 13:58–61, 18:1−3. The FCC limits the power for unlicensed transmitters, and the power limit under the FCC regulations is less than or equal to one watt for the disclosed 902–928 MHz range. Ex. 1010, 217; Ex. 1017, 7:9–11, 31–34. Mr. Geier testifies that an ordinarily skilled artisan “would have understood that an indoor communications network as taught by Tymes requires only a limited range (e.g., 1 mile or less (the length of a storage facility)), so that high-powered transceivers would be unnecessary and disfavored,” and that such an artisan “would have considered a transmission of 1 Watt to be a ‘low-power’ transmission, with a limited range of approximately 1 mile.” Ex. 1003 ¶¶ 358−359. Mr. Geier also testifies that such an artisan would have had a reason to use low-power transceivers in the base stations so that they are usable indoors without licensing under the FCC regulations. Id. We credit Mr. Geier’s testimony as it is consistent with Tymes’ teachings and other evidence. Ex. 1005, 2:36–56, 6:66–7:2, 13:58−61, 18:1−3, Figs. 1, 3, 10; Ex. 1010, 21; Ex. 1017, 7:9−11, 29−34 (explaining that “unlicensed systems using conventional modulation techniques attain ranges on the order of 500−1000 feet” (emphasis added)).” slip op. at 54

  Patent outcomesUS 8,908,842 unpatentable
  Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites Alice · Mayo · Bilski · Enfish · Phillips · KSR · Graham
  Patents in suitUS 8,908,842
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Nov 8, 2017 · IPR2016-01028 · APJ Christopher G Paulraj · IPR · Final written decision

  Claim 1 is unpatentable as obvious over Palermo, the Handbook, and McGinity, and also over McGinity, Joshi, Bastin, and the 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 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. 22–23 (citing Ex.1009 ¶ 17). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 25. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

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

    “The Specification teaches the following: The term “sustained release” is defined for purposes of the present invention as the release of the opioid analgesic from the oral dosage form at such a rate that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over an extended period of time, e.g., from about 12 to about 24 hours as compared to an immediate release product. Preferably the sustained release is sufficient to provide a twice-a-day or a once-a-day formulation. Ex. 1001, 4:56–64. The use of “e.g.” in the above definition for “sustained release” plainly indicates that a 12 to about 24 hour time period is exemplary. Thus, we decline to limit the claim term as Patent Owner would have us do. Rather, we construe “extended release” as “release of the opioid analgesic from the oral dosage form at a rate such that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over a period of time longer than that of an immediate release of the opioid analgesic.”” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “We are unpersuaded by Patent Owner’s arguments. Claim 1 is drawn to a dosage form—a composition. Patent Owner does not point out how the recitation of “abuse deterrent” in the preamble modifies the structurally complete dosage form recited in the body of claim 1. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (“[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). We conclude, therefore, that the term “abuse deterrent” is a goal of the invention, that is, it is merely a statement of intended use that is not entitled to patentable weight.” slip op. at 13

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

    “We agree with Patent Owner that the broadest reasonable construction of “PEG applied onto the core matrix” is a “PEG coating of the core matrix.” Petitioner’s proposed construction would read “applied onto the core matrix” (emphasis added) out of the claim, which we decline to do. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 951 (Fed. Cir. 2006) (noting that claim language “should not [be] treated as meaningless”).” slip op. at 14

  Patent outcomesUS 9,060,976 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 9,060,976
• Instradent USA, Inc. v. Nobel Biocare Services AGSome claims unpatentable
  PTAB · Feb 15, 2017 · IPR2015-01786 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 1–5 and 19 are unpatentable as anticipated by the ABT Catalog; claims 1–5, 19, and 20 were not shown unpatentable as obvious over the Anthogyr Catalog and Update Journal.

  RulingsFinal written decision

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

    “We also do not find that the plain and ordinary meaning of “having” in this claim limitation would be understood to define the coronal region as only the portion with a frustoconical shape. Contrary to Patent Owner’s arguments, the term “having” is generally considered a transitional phrase even when it is not used to separate the preamble from the body of the claim, and it may be treated as open or closed depending on its context in the claim and specification. See, e.g., Lampi Corp., 228 F.3d at 1376 (interpreting the phrase “housing having two half-shells” in the body of the claim as open-ended, thus allowing for additional components in the housing); see also Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001) (noting that “the term ‘having’ does not convey the open-ended meaning as strongly as ‘comprising,’” and “does not create a presumption that the body of the claim is open”); Manual of Patent Examining Procedure § 2111.03 (“Transitional phrases such as ‘having’ must be interpreted in light of the specification to determine whether open or closed language is intended.”). Notwithstanding, the claim drafter specifically chose not to use the conventional phrase for limiting the openness of a claim—“consisting of”; nor did the drafter use the desired shape as an adjective to the structure, e.g., “a frustoconical coronal region.” In the context of this claim, there is nothing that physically or logically prevents the coronal region from “having” a portion that is frustoconical in shape and a portion that is not. We next consider whether this broader interpretation is consistent with the rest of the specification.” slip op. at 10

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

    “2. Remaining Claim Terms We determine that no explicit construction of any other claim term is necessary for our resolution of the issues in this case. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 14

  • Strike new argumentNew argument consideredDecided for petitioner

    “We determine that Petitioner’s Reply does not present improper new arguments and evidence concerning whether the ABT Catalog qualifies as a prior art printed publication. Throughout this proceeding, Petitioner has maintained the position that the ABT Catalog was publicly accessible prior to the May 2003 critical date, and thus anticipates challenged claims 1–5 and 19 under 35 U.S.C. § 102(b). Although Petitioner identified certain evidence in its Petition (e.g., the testimony of Dr. Fromovich) that we recognized had some inconsistencies, Petitioner was not precluded from presenting further corroborating evidence consistent with its overall theory that the ABT catalog was publicly accessible before the critical date. Because Patent Owner contested the sufficiency of the evidence submitted with the Petition in its Patent Owner Response, Petitioner was properly allowed to respond to those arguments in its Reply. See 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response.”). Moreover, as recognized by the Federal Circuit, “the introduction of new evidence in the course of the trial is to be expected in inter partes review trial proceedings and, as long as the opposing party is given notice of the evidence and an opportunity to respond to it, the introduction of such evidence is perfectly permissible under the APA.” Genzyme Therapeutic Products Ltd. P'ship v. Biomarin Pharm. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016); cf. In re NuVasive, Inc., 841 F.3d 966, 973 (Fed. Cir. 2016) (finding APA violation where “the Board refused to permit [patent owner] to file a surreply or even to address the matter during oral argument”). Here, Patent Owner was provided an opportunity to substantively respond to Petitioner’s new Reply evidence in its Sur-Reply. Paper 57, 7. Patent Owner took advantage of that opportunity. Paper 77. Patent Owner also filed a Motion for Observations of the cross-examination testimony of Petitioner’s Reply Declarants. Paper 76. Patent Owner also extensively addressed this evidence during oral argument. See, e.g., Tr. 75:14–83:6. Accordingly, we determine that the evidence submitted with Petitioner’s Reply to support its assertions regarding public accessibility of the ABT Catalog is not improper and may be considered.” slip op. at 17

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “When the totality of the evidence is assessed, 13 we find that the ABT Catalog was made available, without restriction, to members of the interested public at least during the March 2003 IDS Conference. This is similar to the circumstances considered in Klopfenstein and MIT, where the court found that materials distributed or presented during an industry conference constituted a printed publication. Klopfenstein, 380 F.3d at 1348–52; MIT, 774 F.2d at 1109. Here, although there is no evidence that an actual presentation was made, the evidence tends to show that any interested conference attendee could have obtained a copy of the ABT Catalog from the ABT booth during the March 2003 IDS Conference. Moreover, while only one individual (Mr. Chakir) was shown to have actually obtained a copy of the ABT Catalog, we note that “actual retrieval of a publication is not a requirement for public accessibility.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1197 (Fed. Cir. 2008); see also Constant v. Advanced Micro–Devices, Inc., 848 F.2d 1560, 1569 (Fed. Cir. 1988) (“Accessibility goes to the issue of whether interested members of the relevant public could obtain the information if they wanted to. If” slip op. at 25

  Patent outcomesUS 8,714,977 mixed
  Claim construction§ 102 anticipation
  Patents in suitUS 8,714,977

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.