• Innovative Intelligent Products, LLC D/B/A GPS Lockbox v. National Products Inc.Institution denied
  PTAB · Oct 21, 2021 · IPR2021-00767 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood that claims 1–3, 7–11, and 14–18 were unpatentable on any asserted ground.

  RulingsInstitution decision

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

    “It is the petitioner’s burden from the outset to show with particularity why a challenged claim is unpatentable. Harmonic Inc. v. Avid Tech. Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). In that regard, a petition for inter partes review must identify how the challenged claims are unpatentable, and must specify where each element of the claim is found in the relied-upon prior art. 37 C.F.R. § 42.104(b); see also 35 U.S.C. § 312(a)(3) (a petition must identify “with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence that supports the grounds for challenge to each claim”). A petition must also include “a detailed explanation of the significance of the evidence including material facts, and the governing laws, rules, and precedent.” 37 C.F.R. § 42.22(a)(2). Here, the Petition does not identify sufficiently where each element of claim 1 is found in GPS 1, and does not include a detailed explanation of the significance of the evidence.” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner contends that a person having ordinary skill in the art would have had either “a Bachelor’s Degree in mechanical engineering or a related discipline and at least two years of experience in the design or development of interlocking products (e.g. docking cradles and adapters for portable electronic devices),” or “five years or more of experience in the design or development of interlocking products.” Pet. 10. At this stage of the definition, nor provides a definition of its own. See Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition, which is undisputed on this record, except that we delete the qualifiers “at least” and “or more” to eliminate vagueness as to the amount of practical experience. The qualifier, if not deleted, expands the range indefinitely without an upper bound, and thus would preclude a meaningful indication of the level of ordinary skill in the art.” slip op. at 7

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

    “We construe each claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b). Under this standard, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure.2 Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Only those terms in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). 2 Petitioner incorrectly states that claims in an inter partes review are to be construed using the broadest reasonable construction standard, which applied to proceedings filed prior to November 13, 2018. Pet. 10–11; see also 83 Fed. Reg. 51,340, 51,341 (Oct. 11, 2018) (adopting “the same claim construction standard used by Article III federal courts and the ITC, both of which follow Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) and its progeny”). See Prelim. Resp.; Pet. 10–11. For purposes of this Decision, based on the record before us, we determine that none of the claim terms requires an explicit construction.” slip op. at 8

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

    “Claim 1 requires that (1) the adapter comprises a contactor and male positioning interface; (2) the contactor comprises a contactor surface and a plurality of contacts exposed and arranged on the surface that are electrically coupleable to the electronic device; (3) the male positioning interface defines a rim surrounding, and in contact with, a perimeter of the contactor surface of the contactor of the adapter; and (4) the rim guides the proper mating of the contactor of the adapter to the external connector. Ex. 1001, 34:3–13. Petitioner identifies components in the images of the Flex 8 taken from GPS 1 that it purports to be an adapter comprising a contactor with contacts, but does not explain why or how those identified components meet GPS 1 from which we can identify, or discern the function of, any component of the device identified in those images. See Pet. 16–18 (Petitioner’s contentions regarding the adapter limitation of claim 1); see also Ex. 1003 (GPS 1, nowhere identifying any feature of the device by reference to the images). Additionally, Petitioner does not identify anything in the images corresponding to the recited “male positioning interface” or “rim surrounding, and in contact with, a perimeter of the contactor surface . . . to guide proper mating of the contactor of the adapter to the external connector” limitations of claim 1. It is the petitioner’s burden from the outset to show with particularity why a challenged claim is unpatentable. Harmonic Inc. v. Avid Tech. Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). In that regard, a petition for inter partes review must identify how the challenged claims are unpatentable, and must specify where each element of the claim is found in the relied-upon prior art. 37 C.F.R. § 42.104(b); see also 35 U.S.C. § 312(a)(3) (a petition must identify “with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence that supports the grounds for challenge to each claim”). A petition must also include “a detailed explanation of the significance of the evidence including material facts, and the governing laws, rules, and precedent.” 37 C.F.R. § 42.22(a)(2). Here, the Petition does not identify sufficiently where each element of claim 1 is found in GPS 1, and does not include a detailed explanation of the significance of the evidence. Specifically, Petitioner fails to explain with any particularity how or why the images reproduced above support its view that GPS 1 discloses “an adapter coupleable to a portable electronic device for mating with an states that “[u]nder PO’s theories of infringement, GPS 1 discloses these recitations” and provides the annotated images reproduced above. Id. Patent Owner’s infringement contentions, however, are directed to a different product (the ATMOS Temperature Controlling Cradle Kit for Samsung Galaxy TAB A 8" Product), and Petitioner does not explain how that product relates, if at all, to the Flex 8 depicted in GPS 1. Moreover, Petitioner’s citation to Patent Owner’s infringement contentions to support conclusory statements not otherwise supported in the Petition amounts to an improper incorporation by reference. 37 C.F.R. § 42.6(a)(3) (“Arguments must not be incorporated by reference from one document into another document.”). The Petition, therefore, falls short of adequately establishing the identity or function of any component in the images of the Flex 8 from GPS 1. Petitioner states that, although the Petition primarily focuses on GPS 1 because “webpages are most easily reproduced” therein, “the same analysis applies to each of the AP Publications.” Pet. 16. As was the case with Petitioner’s challenge based on GPS 1, the Petition fails to explain with any particularity how the products depicted in GPS 2, GPS 3, and GPS 4 support its view that GPS 2, GPS 3, and GPS 4 each discloses “an adapter coupleable to a portable electronic device for mating with an external connector” as recited in claim 1. Pet. 18–21. Petitioner provides two still images from each of GPS 2, GPS 3, and GPS 4, which appear to show the Flex 8, without annotations or further explanation. Id. The Petition, therefore, also does not identify sufficiently where each element of claim 1 is found in GPS 2, GPS 3, and GPS 4. establishes that any of the AP Publications discloses the recitations of claim 1 directed to “an adapter coupleable to a portable electronic device for mating with an external connector.” Accordingly, we determine that the Petition does not establish a reasonable likelihood that Petitioner will prevail in showing that claim 1, and claims 2, 3, and 7–9 that depend directly or indirectly therefrom, are anticipated by the AP Publications.” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,630,334
• Neosales Corp LP v. Allan WendlingInstitution denied
  PTAB · Sep 14, 2021 · PGR2021-00058 · APJ Wesley B Derrick · PGR · Institution

  The Board denied institution because Petitioner did not show that any challenged claim was more likely than not unpatentable on the asserted obviousness or written-description grounds.

  RulingsInstitution decision

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

    “review. See 35 U.S.C. § 324. The standard set forth in 35 U.S.C. § 324(a) requires Petitioner to demonstrate that it is more likely than not that at least one challenged patent claim is unpatentable. Petitioner has not met that standard and, accordingly, we do not institute a post grant review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would have had at least a High School Diploma with 5 years of experience in the flooring industry” and that they “would also understand that there is a requirement that many accessible surfaces must be slip resistant to minimize hazards to users of the surface.” Pet. 13–14 (citing Ex. 1003 ¶¶ 21–26). On this record, for purposes of this decision, we agree that a person of ordinary skill in the art would have had at least the qualifications set forth in Patent Owner and appears, on this record, to be consistent with the disclosures of the ’285 patent and the asserted prior art references. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that “specific findings on the level of skill in the art . . . [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 8

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

    “Only those claim terms that are in controversy need to be construed and only to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); see also U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (holding claim construction is not necessary when it is not “directed to, or has been shown reasonably to affect, the determination of obviousness”). accordance with their ordinary meaning except for “laminate structure” and “laminated.” Pet. 14–15 (citing Ex. 1003 ¶¶ 36–41). As to these terms, the Petition relies on a quotation, describing what is shown in Figure 3, that includes the term “laminate structure” from the ’285 patent.5 Id. at 15 (“As best shown in FIG. 3, the body is a laminate structure and comprises a bottom elastomeric layer 24 of an elastomeric material . . . floor surface 26.”); Ex. 1001, 2:16–20, Fig. 3. Petitioner also relies on Merriam- Webster’s definition of “laminate” as ‘a product made by laminating,’” where “laminating” means “to unite (layers of material) by an adhesive or other means.” Pet. 15 (quoting Ex. 1013) (citing Ex. 1011 [sic] Ex. 1013). Petitioner contends that “the term ‘laminate structure’ should be construed to mean a ‘body having an adhered elastomeric material’” and that “the term ‘laminated’ should be construed as ‘adhered.’” Id. On this record, and for purposes of this decision, we decline to construe any claim terms beyond the limited extent we do so below in our analysis, because it is not necessary to do so in reaching our decision on institution.” slip op. at 9

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

    “On this record, Petitioner fails to establish a basis for the recited “sticky polyurethane gel layer.” Although it is evident that Haas’ “bonding layer 2” can itself be formed of an adhesive material (see, e.g., Ex. 1009, 5:48–50), it can also be formed of material that is not adhesive (or sticky) (see, e.g., id. at 5:61–63). Petitioner offers no support for Haas’ polyurethane foam layer itself being an adhesive or sticky material. Pet. 21– 24. Further, the disclosure relating to Haas’ polyurethane layer is contrary to the polyurethane being an adhesive or sticky material because Haas teaches applying an adhesive to the polyurethane layer. See, e.g., Ex. 1009, 8:36–38, 11:32–12:43 (Examples I–IV). Likewise, Petitioner offers no support for the polyurethane foam being a polyurethane gel. See, e.g., Pet. 21–24. Petitioner rather merely asserts that its “augmented carpet-to-floor contact system would produce the same effect claimed by a ‘sticky [bonding] polyurethane gel [foam] layer,’” which falls short of establishing that the polyurethane foam meets the limitation requiring gel. Pet. 24. The Phillips Declaration essentially repeats arguments set forth in the Petition, including as to the “sticky polyurethane gel layer that includes a Compare Ex. 1003 ¶¶ 61–67, with Pet. 20–24. The cited testimony, thus, lacks the necessary objective evidence to support the opinions expressed as to Haas teaching or suggesting a “sticky polyurethane gel layer.” See Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (“It is within the discretion of the trier of fact to give each item of evidence such weight as it feels appropriate.”); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”).” slip op. at 16

  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,806,285
• Intel Corporation v. Tela Innovations, Inc.All claims unpatentable
  PTAB · Mar 10, 2021 · IPR2019-01637 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1–11, 15, 18, 20, and 22–24 are unpatentable as obvious over Becker and Greenway; the claims are not entitled to the earlier priority dates.

  RulingsFinal written decision

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

    “We instituted an inter partes review of claims 1–11, 15, 18, 20, and 22–24 of the ’335 patent on the ground of unpatentability alleged in the Petition. Paper 16 (“Dec.”). After institution of trial, Patent Owner filed a Patent Owner Response. Paper 28 (“PO Resp.”). Petitioner filed a Reply. Paper 35 (“Reply”). Patent Owner filed a Sur-Reply. Paper 38 (“Sur- Reply”). An oral hearing was held on December 9, 2020, and a transcript of the hearing is included in the record. Paper 45 (“Tr.”).” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Neither party argues that the outcome of this case would differ based on our adoption of any particular definition of one of ordinary skill in the art. On this record, we find that the differences in the parties’ contentions as to the level of ordinary skill are not consequential, in part because the levels of skill set forth by both Petitioner and Patent Owner are based on a Bachelor’s degree in Electrical Engineering and a length and type of experience that overlap. Accordingly, we adopt Patent Owner’s definition, which overlaps that set forth by Petitioner, particularly regarding a Bachelor’s degree in Electrical Engineering, with five years of experience in semiconductor layout technology and integrated circuit design, and because it is consistent with the cited prior art. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that “specific findings on the level of skill in the art . . . [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 12

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

    “AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b) (2019). Under Phillips, claim terms are afforded “their ordinary and customary meaning.” Phillips, 415 F.3d at 1312. “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Id. at 1313. Only terms that are in controversy need to be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner notes that there are disputed claim terms in the NDCA Action—namely, the terms “gate electrode,” “gate structure(s),” and “contact structure(s)”—but asserts that Becker and Greenway render the challenged claims obvious under any of the proposed constructions. Pet. 31–32. In light of this, Petitioner states that the Board does not need to construe any claim term in order to evaluate the asserted prior art. Id. Patent Owner provides the district court’s construction of the claim terms “gate electrode,” “gate structure(s),” and “contact structure(s)” in the NDCA Action, stating that Patent Owner “applies the District Court constructions” of these claim terms. PO Resp. 21–22. Patent Owner, however, does not expressly argue for those constructions, and states that “Petitioner’s obviousness arguments fail regardless of whether any of the above claims constructions are adopted by the Board.” Id. at 22. On the full record now before us, we determine it is not necessary to construe any claim term expressly to resolve the parties’ dispute. Vivid Techs., 200 F.3d at 803; Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in an inter partes review).” slip op. at 13

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner

    “Application and 2007 Original Application, Patent Owner does not disagree that the smallest gate pitch mentioned therein is 360nm (0.36 μm). Ex. 1005, 8, 9 11; Ex. 1007, 30–31; Pet. 20; PO Resp. passim. Petitioner has reasonably established that the claimed range of less than or equal to about 193nm would extend, at its lower bound, to the single-digit nanometer range. Reply 4–5 (citing Ex. 1061, 329:10–21). The disclosures relied on by Patent Owner in the 2006 Provisional Application and the 2007 Original Application do not support the entire range of gate pitches from 193nm down to the lower bound of the single-digit nanometer range. Pet. 15, 19; compare Ex. 1005, 8, 11 (teaching a gate pitch of 360nm), Ex. 1007, 30–31 (teaching a gate pitch of 360nm) with Ex. 1008, 21–24 (requiring a gate pitch of less than or equal to about 193nm). This does not show possession of the entire range down to the single-digit nanometer range. See Lukach, 442 F.2d at 969. Regarding feature size, the smallest actual feature size mentioned in the 2006 Provisional Application and 2007 Original Application is 65nm. Ex. 1005, 5 (“65nm sized features”); Ex. 1007, 10 (“65 nm sized features”). Figure 1 of the 2006 Provisional Application, titled “Lithography Trends,” emphasizes that Patent Owner did not have possession of smaller gate pitches or feature sizes at the time of that application, but rather, that a 45nm feature size would be expected to be achieved in about 2012. Ex. 1005, Fig. 1; see Lukach, 442 F.2d at 969. We find that the disclosures of the 2006 Provisional Application and the 2007 Original Application do not show possession of the 45nm feature size. Looking next at Patent Owner’s “scalability” theory, we do not agree that the 2006 Provisional Application or 2007 Original Application would inform one of ordinary skill in the art that Patent Owner had possession of the claimed 193nm gate pitch ranges or 45nm feature sizes, or anything smaller, at the time of the 2006 Provisional Application or the 2007 Original Application. In order for Patent Owner to prevail on its argument that the 2006 Provisional Application and the 2007 Original Application support the disclosure of a sub-193nm gate pitch range or 45nm features, the disclosures of those applications must convey with reasonable clarity to one skilled in the art that the inventors possessed the invention claimed in the 2015 Application. See Ariad Pharms., 598 F.3d at 1351. We do not agree that the aspirational language in the 2006 Provisional Application demonstrates that the inventors had possession of the claimed range of gate pitches from 193nm down to the single-digit nanometer range, or possession of 45nm-sized features. Rather, the language of the 2006 Provisional Application describes a layout methodology, but fails to expressly teach scaling down to the gate pitches specified in the 2015 Application or explain to one of ordinary skill in the art how to do so. Even though “scaling” is a mathematical possibility, as argued by Patent Owner, that possibility does not equate to possession of the scaled-down structure itself. At the time of the 2006 Provisional Application and the 2007 Original Application, feature sizes were only “approaching” 45nm (Ex. 1005, 4; Ex. 1007, 3) or “expected to soon approach sizes as small as 45 nm” (Ex. 1007, 10). This language is, in effect, an acknowledgment that 45nm feature sizes were not yet a reality. Further, nothing in the 2006 Provisional Application shows how to make a 45nm feature, or how one of ordinary skill in the art could have made this happen in the 2006/2007 time frame. Similarly, Dr. Khatri’s scaling formula based on “simple geometry” that Patent Owner proposes to apply to the gate pitches and feature sizes identified in the 2006 Provisional Application is not found in that application. See generally Ex. 1005. The application’s use of “Moore’s Law as a crystal ball to predict future reductions in chip dimensions is not the same as inventing a chip with reduced chip dimensions, including reduced gate pitches down to unfathomable single-digit nanometer pitches.” Reply 6. The evidence demonstrates that scaling down feature sizes and gate pitches is not a simple function of time or a mere application of Moore’s Law, but the result of technological innovation that was not in the possession of the inventors at the time of the 2006 Provisional Application or 2007 Original Application. See Ex. 1061, 341:2–9; Ex. 1077, 1283:21–1284:3 (ITC hearing transcript). Thus, we do not agree that, by virtue of Patent Owner’s proposed “scalability” theory, the inventors conveyed with reasonable clarity to one skilled in the art that the inventors possessed the invention claimed in the 2015 Application at the time of the 2006 Provisional Application or 2007 Original Application.” slip op. at 26

  Patent outcomesUS 10,141,335 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,141,335
• Intel Corporation v. Tela Innovations, Inc.All claims unpatentable
  PTAB · Mar 10, 2021 · IPR2019-01636 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1–11, 15, 18, 20, and 22–24 are unpatentable as obvious over Becker and Greenway because Petitioner proved the combination by a preponderance of the evidence.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “Application and 2007 Original Application, Patent Owner does not disagree that the smallest gate pitch mentioned therein is 360nm (0.36 μm). Ex. 1005, 8, 11; Ex. 1007, 30–31; Pet. 20; PO Resp. passim. Petitioner has reasonably established that the claimed range of less than or equal to about 193nm would extend, at its lower bound, to the single-digit nanometer range. Reply 4–5 (citing Ex. 1061, 329:10–21). The disclosures relied on by Patent Owner in the 2006 Provisional Application and the 2007 Original Application do not support the entire range of gate pitches from 193nm down to the lower bound of the single-digit nanometer range. Pet. 15, 19; compare Ex. 1005, 8, 11 (teaching a gate pitch of 360nm), Ex. 1007, 30–31 (teaching a gate pitch of 360nm) with Ex. 1008, 22–23 (requiring a gate pitch of less than or equal to about 193nm). This does not show possession of the entire range down to the single-digit nanometer range. See Lukach, 442 F.2d at 969. Regarding feature size, the smallest actual feature size mentioned in the 2006 Provisional Application and 2007 Original Application is 65nm. Ex. 1005, 5 (“65nm sized features”); Ex. 1007, 10 (“65 nm sized features”). Figure 1 of the 2006 Provisional Application, titled “Lithography Trends,” emphasizes that Patent Owner did not have possession of smaller gate pitches or feature sizes at the time of that application, but rather, that a 45nm feature size would be expected to be achieved in about 2012. Ex. 1005, Fig. 1; see Lukach, 442 F.2d at 969. We find that the disclosures of the 2006 Provisional Application and the 2007 Original Application do not show possession of the 45nm feature size. Looking next at Patent Owner’s “scalability” theory, we do not agree that the 2006 Provisional Application or 2007 Original Application would inform one of ordinary skill in the art that Patent Owner had possession of the claimed 193nm gate pitch ranges or 45nm feature sizes, or anything smaller, at the time of the 2006 Provisional Application or the 2007 Original Application. In order for Patent Owner to prevail on its argument that the 2006 Provisional Application and the 2007 Original Application support the disclosure of a sub-193nm gate pitch range or 45nm features, the disclosures of those applications must convey with reasonable clarity to one skilled in the art that the inventors possessed the invention claimed in the 2015 Application. See Ariad Pharms., 598 F.3d at 1351. We do not agree that the aspirational language in the 2006 Provisional Application demonstrates that the inventors had possession of the claimed range of gate pitches from 193nm down to the single-digit nanometer range, or possession of 45nm-sized features. Rather, the language of the 2006 Provisional Application describes a layout methodology, but fails to expressly teach scaling down to the gate pitches specified in the 2015 Application or explain to one of ordinary skill in the art how to do so. Even though “scaling” is a mathematical possibility, as argued by Patent Owner, that possibility does not equate to possession of the scaled-down structure itself. At the time of the 2006 Provisional Application and the 2007 Original Application, feature sizes were only “approaching” 45nm (Ex. 1005, 4; Ex. 1007, 3) or “expected to soon approach sizes as small as 45 nm” (Ex. 1007, 10). This language is, in effect, an acknowledgment that 45nm feature sizes were not yet a reality. Further, nothing in the 2006 Provisional Application shows how to make a 45nm feature, or how one of ordinary skill in the art could have made this happen in the 2006/2007 time frame. Similarly, Dr. Khatri’s scaling formula based on “simple geometry” that Patent Owner proposes to apply to the gate pitches and feature sizes identified in the 2006 Provisional Application is not found in that application. See generally Ex. 1005. The application’s use of “Moore’s Law as a crystal ball to predict future reductions in chip dimensions is not the same as inventing a chip with reduced chip dimensions, including reduced gate pitches down to unfathomable single-digit nanometer pitches.” Reply 6. The evidence demonstrates that scaling down feature sizes and gate pitches is not a simple function of time or a mere application of Moore’s Law, but the result of technological innovation that was not in the possession of the inventors at the time of the 2006 Provisional Application or 2007 Original Application. See Ex. 1061, 341:2–9; Ex. 1077, 1283:21–1284:3 (ITC hearing transcript). Thus, we do not agree that, by virtue of Patent Owner’s proposed “scalability” theory, the inventors conveyed with reasonable clarity to one skilled in the art that the inventors possessed the invention claimed in the 2015 Application at the time of the 2006 Provisional Application or 2007 Original Application.” slip op. at 26

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Neither party argues that the outcome of this case would differ based on our adoption of any particular definition of one of ordinary skill in the art. On this record, we find that the differences in the parties’ contentions as to the level of ordinary skill are not consequential, in part because the levels of skill set forth by both Petitioner and Patent Owner are based on a Bachelor’s degree in Electrical Engineering and a length and type of experience that overlap. Accordingly, we adopt Patent Owner’s definition, which overlaps that set forth by Petitioner, particularly regarding a Bachelor’s degree in Electrical Engineering, with five years of experience in semiconductor layout technology and integrated circuit design, and because it is consistent with the cited prior art. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that “specific findings on the level of skill in the art . . . [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 12

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

    “On the full record now before us, we determine it is not necessary to construe any claim term expressly to resolve the parties’ dispute. Vivid Techs., 200 F.3d at 803; Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in an inter partes review).” slip op. at 14

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

    “Relying on the Shanfield declaration, Petitioner argues that one of ordinary skill in the art would have been motivated to combine the teachings of Becker and Greenway, and would have had a reasonable expectation of success in doing so. Pet. 40–41 (citing Ex. 1002 ¶¶ 103–106). For example, Petitioner argues that Becker and Greenway are closely related, in that they “apply the same 1D gridded layout style to the design of semiconductor chips,” with Greenway going further than Becker and disclosing “fabricating 1D gridded circuits using ‘next generation’ Interference Assisted Lithography (IAL).” Id. at 40. Petitioner also argues that one of ordinary skill in the art “would have been motivated to combine Greenway with Becker for the additional reason that Greenway’s Interference Assisted Lithography (IAL) seeks to extend the use of 193nm OPL that underpins Becker, and is touted as being compatible with OPL.” Id. at 41. According to Petitioner, there would have been a reasonable expectation of success in combining the teachings of Becker and Greenway “because the authors of Greenway performed ‘circuit and lithography simulations’ to confirm that ‘the proposed bitcell layouts can be successfully printed with IAL.’” Id. (citing Ex. 1002 ¶¶ 105–106). We also find that Petitioner’s contended basis for one of ordinary skill in the art combining the teachings in the manner set forth by Petitioner is supported by the evidence of record. See Ex. 1002 ¶¶ 103–106.” slip op. at 40

  Patent outcomesUS 10,141,334 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 10,141,334
• Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentable
  PTAB · Jul 28, 2020 · PGR2019-00027 · APJ Grace Karaffa Obermann · PGR · Final written decision

  Claims 1–29 are unpatentable as obvious over Harden combined with one or more of Varenna 2011, Gatti, and Muratore; the written-description challenge was not proven.

  RulingsFinal written decision

  • BurdenUnpatentable

    “Based on the full trial record, we find that Petitioner demonstrates by a preponderance of the evidence that the subject matter of claim 1 would have been obvious. Varenna 2011 teaches that neridronate “seems to possess an excellent efficacy profile” in treating CRPS. Ex. 1006, 233. In the context of reporting the use of “[n]eridronic acid for the treatment of bone metabolic diseases,” Gatti teaches that “[i]ntravenous high doses of bisphosphonates are increasingly used for the treatment of [CRPS].”13 Ex. 1008, 1305, 1308. Gatti also reports that a clinical trial of neridronic acid “is underway.” Id. Muratore teaches that neridronate was “efficacious in the treatment of [CRPS].” Ex. 1007, 89. Thus, on this record, each of these references sufficiently teaches the efficacy of neridronic acid or its salt in treating CRPS, suggesting that a person of ordinary skill in the art would have been motivated to use neridronic acid in treating CRPS. With respect to the limitation of claim 1 requiring that the neridronic acid be “parenterally administer[ed],” each of Varenna 2011, Gatti, and Muratore teaches intravenous administration of neridronic acid. Ex. 1006, 233; Ex. 1007, 89; Ex. 1008, 1308. Intravenous administration is a type of parenteral administration. Ex. 1004 ¶ 44. 13 Gatti uses the terms “reflex sympathetic dystrophy syndrome” and “algodystrophy.” Ex. 1008, 1308. On the present record, we interpret both of these terms as synonymous with “complex regional pain syndrome,” “CRPS,” “complex regional pain syndrome type I,” “CRPS I,” “reflex sympathetic algodystrophy,” “reflex sympathetic dystrophy,” and “causalgia.” Ex. 1006, 227 (equating “algodystrophy,” “complex regional pain syndrome type I,” and “CRPS I”); Ex. 1007, 89 (using the term “reflex sympathetic algodystrophy”); Ex. 1019, 713 (equating “complex regional pain syndrome,” “CRPS,” “reflex sympathetic dystrophy,” and “causalgia”). Harden teaches that the Budapest Criteria are used as “clinical diagnostic criteria for CRPS” and that they include changes in skin blood flow, by reference to the symptoms of “temperature asymmetry” and “skin color asymmetry.” Ex. 1009, 274 (Appendix II). Further, Harden teaches that 69.4% of patients diagnosed with CRPS were observed on examination to exhibit temperature asymmetry, and 83.9% were observed on examination to exhibit skin color asymmetry. Id. at 271 (Table 2). Thus, Harden teaches that a majority of patient with CRPS suffer from changes in skin blood flow. Because Varenna 2011, Gatti, and Muratore teach that neridronic acid is effective in treating CRPS, the combination of any of those references with Harden14 would have suggested to a person of ordinary skill in the art that neridronic acid would be effective in alleviating changes in skin blood flow associated with CRPS. Thus, the combination of Harden and one or more of Varenna 2011,” slip op. at 26

  • ExcludeMotion to exclude, deniedMixed

    “Assuming that “October 2011” is hearsay, it is still admissible evidence under Rule 807 of the Federal Rules of Evidence. See Opp. Mot. 3–4 (asserting this hearsay exception). Under Rule 807, a statement “is not excluded,” even if it is hearsay, if it meets two requirements. First, the statement must be “supported by sufficient guarantees of trustworthiness— after considering the totality of circumstances under which it was made and evidence, if any, corroborating the statement.” Fed. R. Evid. 807(a)(1). Second, the statement must be “more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.” Id. at 807(a)(2). Here, both requirements are satisfied. The statement “October 2011” on the face of Varenna 2011 is offered to prove that Varenna 2011 was published in October 2011. This statement is accompanied by several guarantees of trustworthiness. The statements “Received on July 15, 2011” and “Accepted on August 30, 2011,” when offered as corroboration of the October 2011 publication date, are not hearsay. Fed. R. Evid. 801 (statement is hearsay only if offered in evidence “to prove the truth of the matter asserted in the statement”). Accordingly, they may be admitted for this purpose, and they corroborate a publication in October 2011. Moreover, Exhibits 1038 and 1040 also provide some evidence that Varenna 2011 was published in October 2011. Ex. 1038, 1 (article with same title as Varenna 2011 published in “Fascicolo 5 2011”); Ex. 1040, 1 (“Fascicolo 5 2011” published in 2011). Thus, the record contains sufficient guarantees of trustworthiness of Varenna 2011’s statement that Varenna 2011 was published in October 2011. See Opp. Mot. 3 (citing Ex. 1004 ¶¶ 39–40). We find that Varenna 2011’s statement, indicating that the reference was published in October 2011, is “more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.” Fed. R. Evid. 807(a)(2). It is difficult to imagine evidence more probative of the publication date of a journal article than the article’s own contemporaneous statement about when it was published.19 See Opp. Mot. 2–4 (for well-supported arguments on point). Accordingly, we determine that the exception of Rule 807 applies, and we conclude that the statement “October 2011” in Varenna 2011 should not be excluded.” slip op. at 48

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

    “regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’774 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1002, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’774 patent, “[a] method of treating” changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1002, 90:33–40, 91:14–21, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims.” slip op. at 9

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

    “regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’774 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1002, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’774 patent, “[a] method of treating” changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from changes in skin blood flow (claim 1) or abnormal sudomotor activity (claim 16) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1002, 90:33–40, 91:14–21, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims. Moreover, as discussed below with respect to the asserted grounds of obviousness, Petitioner directs us to evidence that the prior art teaches or suggests the subject matter of the preambles, even when those preambles are construed as limiting in accordance with the meaning of “treating” provided in the specification.8 Thus, whether or not we treat the preambles as limiting, the outcome does not change. Given this circumstance, we treat the preambles of the challenged claims as limiting and assign them a meaning consistent with the specification’s definition of “treating.”” slip op. at 9

  Patent outcomesUS 10,039,774 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
  Patents in suitUS 10,039,774
• Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentable
  PTAB · Jul 28, 2020 · PGR2019-00026 · APJ Grace Karaffa Obermann · PGR · Final written decision

  Claims 1–30 are unpatentable as obvious over Harden and one or more of Varenna 2011, Gatti, and Muratore; the written-description challenge fails.

  RulingsFinal written decision

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

    “INTRODUCTION A. Background Grünenthal GmbH (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting a post-grant review of claims 1–30 of U.S. Patent No. 9,931,352 B2 (Ex. 1001, “the ’352 patent”). Antecip Bioventures II LLC (“Patent Owner”) did not file a Preliminary Response. We instituted review of all challenged claims on each of the grounds asserted in the Petition. Paper 6 (“Dec. Inst.”).” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingOther

    “regardless of whether the preambles are limiting. Even if the preambles are limiting, their scope is so broad as to be hardly different from no limitation at all. The specification of the ’352 patent defines “treating” as “includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.” Ex. 1001, 7:43–47. This definition exhibits “reasonable clarity, deliberateness, and precision” and is “‘set out . . . within the patent disclosure’ so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir. 1992)). Accordingly, we give effect to this definition of “treating.” Under the definition of “treating” in the specification of the ’352 patent, “[a] method of treating” hyperalgesia (claim 1) or edema (claim 17) “associated with complex regional pain syndrome” means a method of diagnosing, curing, mitigating, or preventing that condition associated with complex regional pain syndrome, or otherwise affecting the structure or any function of the body of someone suffering from the condition associated with complex regional pain syndrome. To the extent that this requires carrying out the method on a patient suffering from hyperalgesia (claim 1) or edema (claim 17) associated with complex regional pain syndrome, this is already part of the method recited in the body of the claims, Ex. 1001, 90:39–43, 91:23–27, so the preambles provide no additional limitation. To the extent that the preambles require some particular result to be brought about, that result could be the diagnosis, cure, mitigation, or prevention of the symptom in question, or it could be any effect at all on the structure or any function of the patient’s body. Thus, even when construed as limiting, the preambles provide little, if any, further restriction on the scope of the challenged claims beyond that set forth in the body of the claims. Moreover, as discussed below with respect to the asserted grounds of obviousness, Petitioner directs us to evidence that the prior art teaches or suggests the subject matter of the preambles, even when those preambles are construed as limiting in accordance with the meaning of “treating” provided in the specification.8 Thus, whether or not we treat the preambles as limiting, the outcome does not change. Given this circumstance, we treat the preambles of the challenged claims as limiting, and assign them a meaning consistent with the specification’s definition of “treating.”” slip op. at 8

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

    “Petitioner’s asserted references provides data showing that administering neridronic acid improves the symptoms of CRPS. PO Resp. 18–19. But “[o]bviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988). It is sufficient that Varenna 2011, Gatti, and Muratore would have informed the ordinarily skilled artisan that successful treatment of CRPS and its symptoms was likely; there is no requirement that Petitioner show that the prior art taught that success was certain.” slip op. at 15

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

    “qualifies as a printed publication under 35 U.S.C. § 102. PO Resp. 4–17; PO Sur-Reply 14–21. “To qualify as a printed publication, a reference ‘must have been sufficiently accessible to the public interested in the art.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)). “A reference will be considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Id. (quoting Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)) (internal quotation marks omitted). Thus, there are two ways to show that a reference was sufficiently accessible: show it was disseminated or show it was “otherwise made available to the extent that” interested people of ordinary skill in the art could have located it after exercising reasonable diligence. Id. Here, according to Petitioner, the asserted references “are articles published in periodical journals by an identified and reputable publisher.” Reply 3.11 Petitioner argues that the references were “disseminated on the[ir] stated publication date[s].” Id. at 5. We agree.” slip op. at 18

  Patent outcomesUS 9,931,352 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosure
  Patents in suitUS 9,931,352
• Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentable
  PTAB · Jun 22, 2018 · PGR2017-00008 · APJ Sheridan K Snedden · PGR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

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

  • Expert testimonyOther

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

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

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

  Patent outcomesUS 9,283,239 unpatentable
  § 112 disclosure
  Patents in suitUS 9,283,239
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · 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
• L’Oréal USA, Inc. v. Liqwd, Inc.Institution denied
  PTAB · Jul 19, 2017 · PGR2017-00011 · APJ Christopher M Kaiser · PGR · Institution

  The Board denied institution of PGR on claims 1–10 because Petitioner did not show that any claim was more likely than not unpatentable under § 112.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard for instituting a post-grant review is set forth in 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless the Director determines . . . it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner

    “Moreover, “[a]pplicants can define . . . claim scope during prosecution,” just as they can in a patent specification. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1343 (Fed. Cir. 2015). Here, during prosecution of the ’419 patent, the applicant stated that “[t]he term ‘hair coloring agent’ refers to a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” Ex. 1005, 7. To define specific terms used to describe an invention, the applicant need only set out the definition “with reasonable clarity, deliberateness, and precision,” “so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). On the present record, the definition of the term “hair coloring agent” set out in the prosecution history of the ’419 patent is sufficiently clear, deliberate, and precise to give a person of ordinary skill in the art notice that the term is used in the ’419 patent in a manner that does not include substances other than “colorant[s] or pigment[s] that [are] customarily used in hair care products,” even if those other substances might be described as “hair coloring agents” outside the context of the ’419 patent. Ex. 1005, 7. Accordingly, we should give effect to that definition. Because Patent Owner’s proposed construction of “wherein the mixture does not contain a hair coloring agent” gives effect to the prosecution history’s definition of “hair coloring agent,” we adopt Patent Owner’s proposed construction for purposes of the present decision. Thus, on the present record, and for purposes of the present decision, we construe “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.”” slip op. at 6

  • Disclosure Requirements (§112) › Definiteness (Nautilus)Not shown unpatentable

    “to determine the scope of the claims. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown that it is more likely than not that claims 1–10 of the ’419 patent are indefinite.” slip op. at 10

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “wherein the mixture does not contain a hair coloring agent.” Pet. 36–39; Prelim. Resp. 39–40. If “a hair coloring agent” encompasses bleaching agents, then the claims all require a bleaching formulation and simultaneously exclude a bleaching agent, a scope that Petitioner argues is not described in the specification of the ’419 patent. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown it is more likely than not that claims 1–10 of the ’419 patent lack written description support. slip op. at 12

  Claim construction§ 112 disclosure
  Patents in suitUS 9,498,419

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.