• 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 · IPR2019-00170 · 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 remaining 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, 17:2–33. The written description of the ’193 patent uses phrases such as “independent of disease lineage diagnosis,” id. at 2:34–35, 13:17– 18, and “not single disease restricted,” id. at 2:47–49, 13:18–19, 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 based on that individual’s molecular profile. See Ex. 1001, 17:2–33.” slip op. at 20

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “modify Lu’s system with Illumina’s DASL assay. Inst. Dec. 17–18. 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. 52–53. 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.” slip op. at 46

  Patent outcomesUS 9,372,193 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,372,193
• 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
• Presidio Components, Inc. v. American Technical Ceramics Corp.All claims unpatentable
  PTAB · Nov 30, 2016 · IPR2015-01331 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 1–6 are unpatentable: Heron anticipates claims 1–4, and Heron combined with Monsorno ’926 renders claims 5–6 obvious.

  RulingsFinal written decision

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

    “interpreted according to their broadest reasonable construction 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, 2146 (2016). Under that standard, claim terms are given their ordinary and customary meaning, as would be understood by one 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). “Petitioner submits that each term of the challenged claims should be given its ordinary meaning.” Pet. 6. Patent Owner agreed in its Preliminary Response that claim terms should be given their ordinary meaning, and did not propose that any terms be construed separately in its Patent Owner Response. Prelim. Resp. 8. For the purposes of this Final Written Decision, we determine that none of the claim terms in the ’879 patent require express construction.” slip op. at 6

  • ExcludeMotion to exclude, deniedDenied

    “Specifically, Patent Owner seeks to exclude Exhibits 1004, 1006, 1008, 1009, 1010, and 1011, portions of Dr. Randall’s Declaration concerning those exhibits (paragraphs 65–75, 87–94, and 124–151 of Ex. 1012), as well as Appendices E, G, J, L, M, N, O and P of Dr. Randall’s Declaration on the grounds that they relate to patentability challenges that did not form the basis of our Institution Decision in this proceeding. Id. at 2–4, 6, 7. Patent Owner additionally seeks to exclude paragraphs 22 and 25 of Dr. Randall’s Declaration under Fed. R. Evid. 702 for failing to be based on sufficient facts or data. Id. at 4–5. Furthermore, Patent Owner seeks to exclude Exhibit 1015, Dr. Shanfield’s deposition transcript, on the grounds that the testimony cited to at 8:21–9:2 in Exhibit 1015 was objected to for lack of relevance. Id. at 7. Because we did not rely upon any of the exhibits, portions of Dr. Randall’s Declaration, or the cited testimony from Dr. Shanfield’s deposition transcript that are sought to be excluded in this Final Written Decision, we dismiss Patent Owner’s motion to exclude as moot. V.” slip op. at 22

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Although a Reply may properly respond to arguments raised in Patent Owner’s Response (see 37 C.F.R. § 42.23(b)), it is not an opportunity for Petitioner to identify, for the first time, new and different prior art elements that are alleged to satisfy the claim requirements. Here, Petitioner’s reliance on trimming plate 15 is materially different from its prior reliance on capacitor plates 2a, 4a, 2c, 4b, etc., especially with respect to the requirement of “one of said contacts members connecting to an end surface of said electrode layer.” Whereas the Petition pointed to, and our Institution Decision relied upon, Bonini’s teaching that the capacitor plates extend to the left or right side portions of capacitor body 3 in order to contact terminal-forming coating 13 or 14 (see Pet. 17; Inst. Dec. 10; Ex. 1002, 3:5– 21, Fig. 2), Petitioner’s new argument relies upon Bonini’s teaching that trimming plate 15 has a narrow tab 15" having an edge 15' that extends to a difference surface (lateral side margin) of ceramic body 3. See Reply 8; Ex. 1002, 2:69–3:1. Because Patent Owner was not given a fair opportunity in this proceeding to respond to this argument, we consider Petitioner’s argument to be improper under 37 C.F.R. § 42.23(b) as not responding to arguments raised in the Patent Owner Response and, therefore, decline to consider it. See In re Nuvasive, Inc., 2016 WL 6608999, Nos. 2015-01672, 2015-1673, slip op. at 11–13 (Fed. Cir. Nov. 9, 2016).” slip op. at 10

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

    “dielectrics having “coextensive” length and width dimensions. PO Resp. 30–33. We disagree, as we find that requirement satisfied by the capacitor shown in Heron’s figures. Specifically, “FIG. 1 shows in side section view of a capacitor,” “FIG. 2 shows in exploded view four green ceramic layers that are stacked, sintered and terminated to make the capacitor of FIG. 1,” and “FIG. 3 shows in perspective view the capacitor of FIG. 1.” Ex. 1003, 2:25–31, Figs. 1–3. Figures 4, 7, and 8 show side sectional views, while figures 5 and 6 show top views of capacitors with alternate electrode geometries. Ex. 1003, 2:32–36; Figs. 5–8. Taken as a whole, these figures indicate plainly that the lengths and widths of dielectric layers 10 and 11 terminate at the same location, thereby satisfying the “coextensive” requirement. Patent Owner contends that reliance on Heron’s figures is improper under the Federal Circuit’s decision in Hockerson-Halberstadt, Inc. v. Avia Group Int’l, Inc., 222 F.3d 951, 956 (Fed. Cir. 2000). PO Resp. 31–33. We do not find Hockerson’s holding to be applicable here. Unlike with the claim at issue in Hockerson, which was construed to require that the “central longitudinal groove” has a width that must be less than the combined width of the two peripheral fins, the challenged claims do not require any particular size or proportion. The requirement that the dielectric layers have coextensive length and width dimensions can be assessed by simply viewing the figures of Heron, and no additional measurements are necessary to make that determination. It is well established “that a claimed invention may be anticipated or rendered obvious by a drawing in a reference, whether the drawing disclosure be accidental or intentional.” In re Meng, 492 F.2d 843, 847 (CCPA 1974). Patent Owner also contends that the Petition fails to identify what specific elements in Heron correspond to numerous claim elements. PO Resp. 34–37. We disagree. As noted above, the Petition identifies specific teachings of Heron, and includes a claim chart mapping Heron’s teachings to the claim elements. Pet. 18–24. In particular, Patent Owner argues that the Petition does not specify where the claimed “electrode layer” is found in Heron. PO Resp. 34–35. As Patent Owner recognizes, however, the Petition identified overlapping buried electrodes 15 and 16 for this claim element. See Pet. 19–20. We find this to be sufficient as both layers 15 and 16 satisfy the claim requirements of having dimensions smaller than the dielectric layer, being mounted on the first surface of a dielectric layer, and extending to a side face of the capacitor body so as to contact the end terminations. Patent Owner also argues that the Petition fails to specify where in Heron “opposite polarity” is taught. PO Resp. 35–36. We find that the Petition’s identification of end terminations 22 and 24 is sufficient. See Pet. 23–24. As explained by Petitioner’s expert, Dr. Randall, in order to store charge, a voltage must be imposed across the terminals of Heron’s capacitor, “and the resulting voltage difference across the two contact members 22 and 24 establishes the opposite polarities of the capacitor.” Ex. 1014 ¶ 38. Finally, Patent Owner argues that the Petition fails to specify where “said second surface of said first dielectric layer” is found in Heron. PO Resp. 36–37. The Petition, however, noted that “[a]s seen in Fig. 2, each dielectric layer has a length and width, as well as a first and second surface.” Pet. 19. The Petition further notes that “Heron discloses that green ceramic (dielectric) layer 10 would be first formed and screen printing the electrode pattern 15 thereon.” Id. at 18. Because the Petition identifies electrode layer 15 as being on the “first surface” of the first dielectric layer 10, we find that the Petition also sufficiently identified the opposite surface of dielectric layer 10 as satisfying the requirements of the “second surface.” Figure 1 of Heron shows terminations 22 and 24 provided on the bottom, i.e., “second surface,” of the dielectric layer and extending to the edges of the capacitor body. The Petition, therefore, identified sufficiently the specific features of Heron’s capacitor that correspond to the claim elements. Based on those identified features, and the record developed during this proceeding, we find that Heron anticipates claims 1–4.” slip op. at 18

  Patent outcomesUS 6,992,879 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 6,992,879
• Presidio Components, Inc. v. American Technical Ceramics Corp.All claims unpatentable
  PTAB · Nov 30, 2016 · IPR2015-01330 · APJ Christopher G Paulraj · IPR · Final written decision

  Claim 1 is unpatentable as anticipated by Horie and Coleman under § 102.

  RulingsFinal written decision

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

    “argues that “the second electrode layer” must be formed on the external capacitor surface that is mounted on the current source. PO Resp. 7–16. We disagree. Nothing in the claim language suggests that a second electrode layer must be positioned in relation to the current source. Rather, the claim specifies only “a second electrode layer formed as a pad for contact with the second surface of the first dielectric layer,” wherein the first dielectric layer is an internal layer of the monolithic capacitor chip. Patent Owner relies upon the opinion of its expert, Dr. Stanley R. Shanfield, Ph.D., to assert that “pad” ordinarily means “mat” or “cushion” and thus connotes a mounting or landing surface, such as against a printed circuit board. Id. at 8 (citing Ex. 2003 ¶ 38). In support of this opinion, Dr. Shanfield cites a) a general dictionary definition of “pad” from the Merriam-Webster’s Collegiate Dictionary (10th ed. 1993) , and b) a 2003 (post-filing date) document entitled “Microwave Office Element Catalog” describing a “multiplate ceramic chip capacitor” with an indication that one can “set size and properties of contact pads.” Ex. 2003 ¶¶ 38–39, Exs. C and D. Neither extrinsic document, however, specifies that an electrode layer that is formed as a contact pad for a multilayer chip capacitor must necessarily be mounted on the printed circuit board or otherwise close to the current source. Moreover, during oral argument, Patent Owner acknowledged that the printed circuit board is not part of the claimed device. Tr. 80:1–4.” slip op. at 7

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

    “with the claim at issue in Hockerson, which was construed to require that the “central longitudinal groove” has a width that must be less than the combined width of the two peripheral fins, challenged claim 1 does not require any particular size or proportion. The requirement that the dielectric layers have co-extensive length and width dimensions can be assessed by simply viewing the figures of Horie, and no additional measurements are necessary to make that determination. It is well-established “that a claimed invention may be anticipated or rendered obvious by a drawing in a reference, whether the drawing disclosure be accidental or intentional.” In re Meng, 492 F.2d 843, 847 (CCPA 1974). Moreover, the specification of Horie is not “completely silent on the issue” of whether the dielectric layers are co-extensive. Cf. Hockerson, 222 F.3d at 956. In particular, Horie discloses that “the laminated body obtained is cut in vertical and horizontal directions to obtain each chip-like laminated body.” Ex. 1002, 7:11–13.3 Although Patent Owner suggested that the use of the terms “vertical” and “horizontal” in Horie could nonetheless encompass cutting the layers at an angle (Tr. 95:15–97:4), we find no support for that position. We, thus, find that Horie’s teaching that each layer in the laminate comprising the capacitor body is cut to the same length and the same width dimensions, in combination with Figure 3, satisfies the “co-extensive” requirement. See Ex. 1013 ¶¶ 32–34.” slip op. at 15

  • ExcludeMotion to exclude, grantedOther

    “PATENT OWNER’S MOTION TO EXCLUDE Patent Owner filed a motion to exclude certain evidence. Paper 28. Specifically, Patent Owner seeks to exclude certain exhibits and the portions of Dr. Randall’s testimony concerning patentability challenges that did not form the basis of our Institution Decision in this proceeding. Id. at 2–6. Petitioner filed a response indicating that it does not dispute Patent Owner’s motion to exclude for any reason. Paper 30. Because we did not rely upon any of the evidence sought to be excluded in our Final Written Decision, we dismiss Patent Owner’s motion to exclude as moot. V.” slip op. at 23

  Patent outcomesUS 6,337,791 unpatentable
  Claim construction§ 102 anticipation
  Patents in suitUS 6,337,791
• Fresenius-Kabi USA LLC v. Cubist Pharmaceuticals, Inc.All claims unpatentable
  PTAB · May 12, 2016 · IPR2015-00227 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 16, 17, 34, and 35 are unpatentable as obvious over the ’226 patent and Woodworth.

  RulingsFinal written decision

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

    “We find nothing in the prosecution history, however, to suggest clearly that either the examiner or the applicants considered a “dosage interval that minimizes skeletal toxicity” to require anything beyond administering daptomycin at the expressly recited dosage interval required by claim 47 (i.e., once every 48 hours). Indeed, in amending then pending claim 32 in response to the Examiner’s § 112, ¶ 2 rejection on the grounds that the claims do not recite an “essential element of the invention,” the applicants added the entirety of the language “wherein said single dose is formulated for administration to a human patient at a dosage interval of once every 24 hours to once weekly and that does not result in muscle toxicity.” Ex. 2013, 3; Ex. 2014, 3. Thus, Patent Owner plainly equated a dosage interval that does not result in muscle toxicity to once every 24 hours to once weekly. Patent Owner has not pointed to any other intrinsic or extrinsic evidence to indicate what else might be required for a dosage interval that minimizes skeletal muscle toxicity. Accordingly, we maintain our claim construction for purposes of this Final Decision.6” slip op. at 8

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

    “2. Remaining Claim Terms We determine that, for purpose of this Final Written Decision, none of the other terms in the challenged claims requires express construction.” slip op. at 9

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

    “We find that the teachings of the ’226 patent and Woodworth, when considered together and in their entirety, would have guided the skilled artisan to once-daily administration of daptomycin at doses of 4 mg/kg and 6 mg/kg. Contrary to Patent Owner’s arguments, the fact that an infinite number of values can fall within the prior art’s non-integer range does not necessarily render its disclosure boundless or otherwise meaningless. We recognize that the ’226 patent discloses a broader dosing range than what it claimed, calculated as between 1.4 and 14 mg/kg, which is not limited to only integer values falling within that range. Nonetheless, we find that the ’226 patent would sufficiently suggest to the skilled artisan that daptomycin can be administered at dosage amounts falling within the disclosed range as a “single daily dose” (i.e., a dosing interval of once every 24 hours) over extended time periods. Ex. 1008, 10:59–63. Moreover, as noted by the Federal Circuit in the Hospira decision, Woodworth more specifically discloses once-daily administration of daptomycin at doses falling within the narrower range of 4 to 6 mg/kg. Ex. 1031, 20. We reach the same conclusion based on our own review of Woodworth. In particular, the endpoints of the range disclosed in the abstract and conclusion of Woodworth, as well as the specific dosages of 4 mg/kg and 6 mg/kg used in the single-dose studies described therein, would have led a skilled artisan to try the claimed dosage amounts for a daptomycin dosing regimen. See Ex. 1009, Abstract (“doses of 4 to 6 mg/kg/day, possibly in divided doses, are predicted to be effective”), 319 (“volunteers were administered daptomycin in successive single doses of 2, 3, 4, and 6 mg/kg”), 324 (“our data suggest that good antibacterial activity would be produced from single doses of 4 to 6 mg/kg”).” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “We are unpersuaded by these arguments, as Woodworth plainly concludes, based on the single dose studies described therein, that daptomycin “doses of 4 to 6 mg/kg/day, possibly in divided doses, are predicted to be effective.” Ex. 1009, Abstract. We agree with the Federal Circuit that, “[w]hile it is true that the Woodworth reference is predictive in nature, it is based on extensive laboratory research, and its predictions of the efficacy of a dosage regimen of 4 mg/kg to 6 mg/kg at daily intervals give rise to a reasonable expectation that dosages in that amount would be effective in patients.” Ex. 1031, 21. We do not consider Woodworth’s description of a simulation that required an “unrealistic dose” of 20 to 25 mg/kg based on certain assumptions to teach away from the claimed doses of 4 mg/kg and 6 mg/kg because it does “not criticize, discredit, or otherwise discourage investigation into the invention claimed.” Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013). Indeed, Patent Owner fails to mention in its briefing that Woodworth also describes “[a]nother simulation [that] used concentrations closer to those anticipated from multiple dosing of 6 mg/kg.” Reply 14; Ex. 1009, 324.” slip op. at 14

  Patent outcomesUS 6,468,967 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 6,468,967
• BMC Medical Co. Ltd. / 3b Products, L.L.C. et al. v. Resmed LimitedAll claims unpatentable
  PTAB · Jan 19, 2016 · IPR2014-01196 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 1–7 are unpatentable: claims 1 and 4–7 as anticipated by Schätzl, claim 3 as obvious over Schätzl and Daniell, and claims 1 and 2 as obvious over Prime, Schätzl, and Dobson.

  RulingsFinal written decision

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

    “According to Petitioner, Schätzl’s “tub element 1” corresponds to the claimed base, “pot part 2” corresponds to the claimed top cover, and “seal structure 6” corresponds to the claimed seal disposed between the base and top cover. Pet. 15–16. Also according to Petitioner, Schätzl’s mountable housing 4 corresponds to the claimed connecting structure, including a base that supports the mountable housing 4, heating device 14, and fastening appliance 20. Id. at 16–17. Petitioner asserts that fastening appliance 20 couples the humidifier to the CPAP apparatus and corresponds to the claimed retaining mechanism. Id. Petitioner also argues that tub element 1 is disclosed as having heat-conducting material in its bottom area 15 that is in contact with heating device 14. Id. at 17 (citing Ex. 1002, 5:13–21). Patent Owner has not directed any arguments to this anticipation challenge. As we indicated in our Scheduling Order, “any arguments for patentability not raised in the [Patent Owner’s] response will be deemed waived.” Paper 8, 5. Indeed, during the oral hearing, Patent Owner’s counsel admitted that Schätzl anticipates claim 1 of the ’453 patent. Tr. 45:6–15. Upon consideration of the arguments and evidence made of record in this proceeding, we determine that Petitioner has demonstrated by a preponderance of the evidence that Schätzl anticipates claims 1 and 4–7.” slip op. at 8

  • Obviousness (§103) › KSR rationalesUnpatentableMotivation foundUnpatentable

    “knob to control a heat setting of the heating element.” Petitioner has shown that Schätzl discloses switching means 27 for controlling heating of water in the humidifier. Pet. 20. Petitioner has further shown that Daniell discloses a humidified CPAP system in which a dial controls heating of a heater plate to heat water in a humidification chamber. Id. at 21. Petitioner has also demonstrated that the substitution of Daniell’s control knob for Schätzl’s switching means would have been an obvious design choice to provide patients with easy temperature control. Id. (citing Ex. 1004 ¶ 52). Patent Owner also does not direct any arguments to this obviousness challenge. Upon consideration of the arguments and evidence made of record in this proceeding, we determine that Petitioner has demonstrated by a preponderance of the evidence that claim 3 is unpatentable for obviousness over Schätzl and Daniell.” slip op. at 8

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

    “teachings of Schätzl and Dobson could be applied to Prime so that the inlet and outlet of Prime’s humidifier are maintained in the top cover. PO Resp. 22–34. We disagree. Petitioner has articulated a specific rationale for using a connecting structure, as taught by Schätzl, rather than a hose connection that “can easily be accidently snagged or struck by the patient” and “cut or torn in use.” Pet. 50 (citing Ex. 1019, 1:29–38). Patent Owner’s arguments are largely premised upon the ability to physically combine the structures disclosed in Prime and Schätzl. For example, Patent Owner argues that “the obvious problem with using Prime’s humidifier in Schätzl’s connecting structure is that the humidifier inlet 4 and outlet 5 are provided in completely different locations (i.e., the upper surface 6 of the humidification chamber 1) than the inlet and outlet openings in Schätzl’s connecting structure (mountable housing 4).” PO Resp. 28–29. It is well established, however, that the criterion for obviousness is “not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole.” In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985); see also In re Keller, 642 F.2d 413, 425 (CCPA 1981) (“The test for obviousness is not 6 We refer herein to the page numbers added to the very bottom of Ex. 2017. whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference . . . .”). Here, even though the locations of the inlets and/or outlets may need to be modified in order to utilize Schätzl’s connecting structure with Prime’s humidifier, the record establishes that a skilled artisan would have been able and motivated to do so.” slip op. at 11

  • ExcludeOther

    “demonstrated by a preponderance of the evidence that claims 1 and 2 are rendered obvious by the combination of Prime, Schätzl, and Dobson. III. PETITIONER’S MOTION TO EXCLUDE EVIDENCE Petitioner moves to exclude certain portions of the Declarations submitted by Patent Owner (Ex. 2008; Ex. 2009), as well as Exhibits 2012– 2018. Paper 14. Because our decision does not rely on any of the challenged exhibits, we dismiss Petitioner’s Motion to Exclude Evidence as moot. IV. CONCLUSION We conclude that Petitioner has demonstrated by a preponderance of the evidence that claims 1 and 4–7 are anticipated under 35 U.S.C. § 102 by Schätzl, that claim 3 is rendered obvious under 35 U.S.C. § 103 by Schätzl and Daniell, and that claims 1 and 2 are rendered obvious under 35 U.S.C. § 103 by Prime, Schätzl, and Dobson.” slip op. at 12

  Patent outcomesUS RE44,453 unpatentable
  § 102 anticipation§ 103 obviousness

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.