• Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentable
  PTAB · Dec 28, 2018 · IPR2017-00440 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–4, 6–7, 10–16, 18, and 20 are unpatentable; claims 5 and 8 are not shown unpatentable. Substitute claims 21, 30, and 38 are unpatentable as obvious over Sackier and Kirsch.

  RulingsFinal written decision

  • Expert testimonyOther

    “3. Dr. Nicosia’s Declaration in support of its Opposition to Patent” slip op. at 7

  • Skill levelOther

    “B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the” slip op. at 16

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

    “B. “clip” The Parties now agree that “clip,” as the term is generally understood,” slip op. at 14

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

    “as recited in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). We conclude that Petitioner has not met its burden of showing this element to be present in Sackier because Petitioner combines features from distinct embodiments in Sackier without establishing persuasively that those embodiments are so directly related to each other such that one of ordinary skill in the art, looking at the reference as a whole, would recognize a disclosure of the invention as claimed. Accordingly, although a very close call, we conclude that Petitioner has failed to demonstrate anticipation of claims 1, 12, and 20 by Sackier for this reason.” slip op. at 21

  Patent outcomesUS 9,271,731 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,271,731
• Google LLC v. Ipa Technologies Inc.Rehearing denied
  PTAB · Dec 20, 2018 · IPR2018-00476 · APJ Debra K Stephens · IPR · Rehearing

  The Board denied Google's rehearing request, leaving institution denied for claims 1–27 because Cheyer was not shown reasonably likely to qualify as publicly accessible prior art.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “trial is set forth in 37 C.F.R. § 42.71(c), which provides in relevant part: “When rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” Section 42.71(c), in turn, references 37 C.F.R. § 42.71(d), which provides a request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply” (37 C.F.R. § 42.71(d)). The party challenging a decision bears the burden of showing the decision should be modified (id.).” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot reached

    “how to retrieve Cheyer, included in Moran’s footnote citation, did not persuade us that Cheyer was publicly accessible (id. at 15; see Pet. 3)). Importantly, we note Petitioner has not shown the link provided in the footnote worked, or that the link, which is to a “Bibliography” page (see Ex. 1029), provided Cheyer’s paper or a publicly accessible link to Cheyer’s paper. In particular, Petitioner does not provide a copy of this Bibliography page to show what actually was on this page and how or if an ordinarily skilled artisan would have been able to access Cheyer’s paper from the Bibliography page. In our Decision, we noted Petitioner failed to provide testimonial or other evidence that the link provided in the article actually worked at the relevant time period, what content was included at the linked website, how one would find Cheyer after selecting the link, or which version of Cheyer allegedly was accessible via the link (Dec. 15). We also explained that this latter showing is of special importance here because Petitioner acknowledges that there were several different versions of Cheyer (id. at 12 (citing Pet. 3)).” slip op. at 8

  • Strike new argumentNew argument disregardedDecided for patent owner

    “professional computer scientist or engineer directed to find an article on a section of a website would have been unable to do so with reasonable diligence” (id. at 7–8). Petitioner’s argument fails for several reasons. First, it is a new argument not appropriately raised on rehearing. Second, Petitioner identifies no support in the record for the assertion that Cheyer was actually available (see Ex. 2001 and 2002) or that an ordinarily skilled artisan would have been able to find Cheyer, only Petitioner’s speculation.2 Finally, this argument overlooks that the burden is on Petitioner, not the Board, to demonstrate a reasonable likelihood of prevailing on this issue.” slip op. at 7

  § 102 anticipation
  Patents in suitUS 6,757,718
• Abs Global, Inc. v. Cytonome/St, LLCRehearing denied
  PTAB · Dec 14, 2018 · IPR2017-02163 · APJ Timothy J Goodson · IPR · Rehearing

  The Board denied ABS Global’s rehearing request, leaving in place its denial of institution because the Petition did not show that Weigl teaches the claimed focusing regions.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. LEGAL STANDARD In a request for rehearing, “[t]he burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). Further, “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 2

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

    “our Decision Denying Institution (Paper 11, “Decision” or “Dec.”). In that Decision, we concluded that Petitioner did not show a reasonable likelihood of prevailing in showing that any of the challenged claims of U.S. Patent No. 7,311,476 B2 (“the ’476 patent”) are unpatentable on any of the asserted grounds. See Dec. 22–27. Petitioner requests rehearing, arguing that we misapprehended or overlooked disclosures in Weigl,1 which was the primary reference Petitioner relied on in the asserted grounds. See Req. Reh’g 1. For the reasons set forth below, Petitioner’s request for rehearing is denied.” slip op. at 2

  • BurdenDecided for patent owner

    “helpful context, but in analyzing whether a petitioner has shown that the cited reference teaches a particular limitation, we look primarily to the section of the petition presenting arguments regarding that limitation. This flows from “the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim,’” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)), as well as the requirement that “the Board must base its decision on arguments that were advanced by a party, and to which the opposing party was given a chance to respond.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016). See also Sirona Dental Systems GmbH v. Institut Straumann AG, 892 F.3d 1349, 1356 (Fed. Cir. 2018) (“It would . . . not be proper for the Board to deviate from the grounds in the petition and raise its own obviousness theory. . . .”). Here, the Request does not point to, and we do not find, any discussion of a constant-depth configuration in Weigl, in the Petition’s arguments regarding the “primary focusing region” and “secondary focusing region” limitations. See Pet. 39–44. Instead, as noted above, the Petition’s annotated drawings illustrating its contentions regarding these limitations show channel depth increasing, and the center fluid maintaining its dimensions as it flows downstream. The Request also argues that, leaving aside the constant-depth configuration, even a channel with increased depth would still serve to accelerate and narrow the center fluid. Req. 7–10. But here again, Petitioner did not present any such argument in the portion of its Petition arguing the “primary focusing region” and “secondary focusing region” limitations. See Pet. 39–44. The Request points to the summary of Weigl in the “Background of the Technology” section of the Petition. Req. 7–10 (citing Pet. 10–11). As such, we are not persuaded that our Decision overlooked or misapprehended Petitioner’s arguments regarding the “primary focusing region” and “secondary focusing region” limitations.” slip op. at 3

  None
  Patents in suitUS 7,311,476
• Becton, Dickinson And Company v. B. Braun Melsungen AGNo claims unpatentable
  PTAB · Dec 12, 2018 · IPR2017-01588 · APJ Michael L Woods · IPR · Final written decision

  The Board found claims 12, 13, 20–23, and 29 not shown unpatentable under any of four § 103 combinations; the contingent motion to amend was dismissed as moot.

  RulingsFinal written decision

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) does not applyDecided for patent owner

    “Because the term “means” is not used, there is a presumption that the limitation is not subject to § 112 ¶ 6, and Petitioner has not overcome this presumption. See Williamson, LLC, 792 F.3d at 1349 (explaining that the presumption is overcome “if the challenger demonstrates that the claim term fails to ‘recite sufficiently definite structure’ or else recites ‘function without reciting sufficient structure for performing that function’”) (internal citation omitted). The claims do not simply recite a “needle protective device,” without more, but explicitly require that the “needle protective device [be] positioned proximally of the valve and at least in part around the needle and distal of a proximal end of the second hub in a ready position and configured to prevent unintended needle sticks in a protective position.” Ex. 1001, 13:58– 61 (emphasis added to structural limitations of claim 12); see also id. at 14:51–55 (reciting similar structure in independent claim 23). Petitioner fails to address these structural limitations in its proposed claim construction, instead focusing only on the three words “needle protective device.” See Pet. 11–15. Moreover, Petitioner’s proposed construction would seemingly render superfluous several of these other claimed structural features. As argued by Patent Owner, we determine that the needle protective device limitation recites sufficient structure. Mr. Meyst explains how a person of ordinary skill in the art “would recognize that the claimed ‘needle protective device’ refers to the class of structures included in safety IV catheters that prevent unintended needle-sticks by covering (i.e., protecting or guarding) the needle tip.” Ex. 2001 ¶ 56 (citing Ex. 2014, which is cited in the ’735 patent). We find Mr. Meyst’s testimony persuasive.” slip op. at 13

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

    “of the claimed limitation. Here, the claims require the “arm” to extend distally of the third hub. Ex. 1001, 13:34–14:59. “[I]n determining the ordinary and customary meaning of the claim term as viewed by a person of ordinary skill in the art, it is appropriate to consult a general dictionary definition of the word for guidance.” See Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348 (Fed. Cir. 2010) (citation omitted). In consulting general dictionary definitions, including that submitted by Petitioner (Ex. 1008), we find “arm” to be defined as: “any armlike part or attachment, as the tone arm of a phonograph” (www.dictionary.com (last visited Nov. 13, 2017) (emphasis added)); “[a] part attached to or projecting from something” (Ex. 1008); “a long thin piece that is connected to the main part of a machine, structure, etc., and that looks or moves like a human arm” (www.learnersdictionary.com (last visited Nov. 13, 2017) (emphases added)). We also consult the prosecution history of record. In an amendment dated February 7, 2013, the applicant asserted that “[t]he scope of independent claims [1 and 23] can be found in FIGs. 13 and 14 of the instant application and corresponding written description.” Ex. 1010, 10. We now review the Specification, namely, Figures 13 and 14 and their accompanying description. We find that these figures depict an “arm” extending distally of a “third hub,” and to illustrate this structure, we reproduce Figure 13 of the ’247 patent, below: The ’247 patent describes: The third housing 204 incorporates a pair of arms 210 each comprising a hook 212. The two hooks 212 are configured to engage the two bumps 36 to retain the third housing 204 to the catheter hub 14 in a ready to use position. The two arms 210 are preferably flexible to provide a gripping force against the two bumps 36, which is higher than the frictional force to withdraw the needle through the tip protector 202, hemostatic valve 46, and catheter 12. Alternatively the two arms 210 can be biased radially outward to increase the gripping force. Further, the two arms can be biased inwardly against the needle shaft to decrease the gripping force after the needle is withdrawn proximal of the arms 210. Ex. 1001, 11:33–45 (emphasis added).” slip op. at 18

  • Skill levelSkill level board ownDecided for petitioner

    “Neither Patent Owner nor Petitioner disputes our initial determination of a person having ordinary skill in the art (“POSITA”), and we see no reason to revisit it here. See, generally, PO Resp.; see also, generally, Pet. Reply. Accordingly, and as explained in our Decision to Institute, we determine that a POSITA would be either a medical practitioner (e.g., a nurse or doctor) having at least some experience with vascular catheter devices, or a person with a technical degree (e.g., associate’s degree in engineering or physics) and having at least some experience with vascular catheter devices. Paper 8, 17–18.” slip op. at 22

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Having considered Callaway in its entirety, and after weighing the competing testimony of Mr. Griffis and Mr. Meyst, we agree with Patent Owner and credit its expert that Callaway’s “third hub” 21 would do “nothing more than hold the spring clip in place until the needle is withdrawn,” and that the “only embodiment in which the inner catheter hub (21) potentially adds any needle protection is in the Critikon version” (PO Resp. 35), which does not integrate Woehr-630’s safety clip (Ex. 1004 ¶ 62), and which Petitioner does not rely on (see Pet. 26–27). Accordingly, because Petitioner fails to demonstrate by a preponderance of the evidence that Callaway teaches Woehr-630’s spring clip retained in hub 21 after the needle is withdrawn, Petitioner has not shown that claims 12, 13, 20–23, and 29 are unpatentable over Woehr, Callaway, and Sutton.” slip op. at 50

  Patent outcomesUS 8,460,247 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,460,247
• Toyota Motor Corp. / Aisin Seiki Co., Ltd. v. Intellectual Ventures II LLCAll claims unpatentable
  PTAB · Dec 12, 2018 · IPR2017-01495 · APJ Amanda F Wieker · IPR · Final written decision

  Claims 24–27 are unpatentable as obvious over Zimmerman, Stephan, and Neal, and independently over Gould and Neal.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Based upon our review of the ’348 patent and the types of problems and solutions described in the ’348 patent and applied prior art, we determine that an ordinarily skilled artisan would have a bachelor’s degree in mechanical engineering, electrical engineering, chemical engineering, or an equivalent degree, and two years of experience in the design of electric motors and electromagnetic devices, including familiarity with the design, operation, materials, and fabrication of such devices, including their thermal and fluid characteristics.4 Although Patent Owner disputes whether an electrical engineering degree is sufficient educational experience for a POSITA, the cited testimony does not present any persuasive or specific basis upon which to determine that an electrical engineering degree, coupled with the cited experience, would be insufficient, as compared to a mechanical or chemical engineering degree. See Ex. 1132 ¶¶ 30–31 (Dr. Trumper opining that a POSITA may possess an electrical engineering degree); Ex. 2009 ¶ 23 (Dr. Garris disputing only whether Dr. Trumper considered that the claims concern “electrically controlled fluid control devices,” but not discussing whether an electrical engineering degree would be sufficient); Ex. 1136 ¶¶ 26–27 (Dr. Toliyat opining that a POSITA of the ’348 patent may have “a degree in electrical engineering”); Ex. 1138, 22:12– 17, 23:14–21, 24:18–22 (opining that a POSITA could have an electrical engineering degree).” slip op. at 14

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We have considered Dr. Garris’s competing testimony that “[h]aving a flush connection to the cooling coil 80 is not superior to Zimmerman’s design, and Dr. Trumper identifies no such advantages.” Ex. 2009 ¶ 120; see also PO Resp. 45. However, Dr. Garris does not explain the basis for his opinion. For example, Dr. Garris neither explains why Zimmerman’s existing design is preferable to a flush connection, nor weighs the numerous advantages offered by Dr. Trumper: “easier assembly,” “simpler construction,” “fewer parts,” or “easier manufacturing and assembly.” As such, weighing the competing testimony of both declarants, we find Dr. Trumper to be more persuasive, given the lack of supporting basis for Dr. Garris’s opinion. We disagree with Patent Owner’s argument that the proposed modification would not have been obvious to a POSITA because it would require modifying Zimmerman’s casting mold to include a more complex shape with a conduit-shaped inlet and outlet. PO Resp. 45 (citing Ex. 2009 ¶ 119). This argument ignores the fact that, under Petitioner’s proposed modification, Zimmerman’s resin sheath would be formed of injection-molded thermoplastic—casting molds would not be used. See supra Section II.D.4.iii. As such, this argument is not responsive to the proposed ground of unpatentability. Moreover, the evidence of record suggests that injection molding is well-suited to the formation of complex shapes. Ex. 2005, 34 (explaining that “injection molding makes discrete parts that can have [a] complex and variable cross section”). Finally, we disagree with Patent Owner’s argument that this would not be a simple substitution. PO Resp. 45 (citing Ex. 2009 ¶¶ 121–122). In paragraph 121 of his declaration, Dr. Garris states that “[s]imply because an engineering design or process is known, that does not mean that the design or process is a satisfactory ‘substitute’ for another design or another process. Whether two elements may qualify as substitutes depends on their suitability to address the specific design problem being addressed.” Ex. 2009 ¶ 121. Although this statement may be true, Dr. Garris does not address the facts of Petitioner’s proposed modification. For example, Dr. Garris does not dispute that connecting Zimmerman’s coil 80 to tube fittings 78, 81 with the resin sheath, rather than through Zimmerman’s existing structure, would suitably solve the design problem. Nor does Dr. Garris explain why these would not be simple substitutes. By contrast, Dr. Trumper identifies a similarly formed line connection in the prior art (Ex. 1132 ¶ 85), and explains why such an arrangement would be a desirable and obvious substitute if employed in Zimmerman’s sheath (id.).7 As such, on the record before us, we determine Dr. Garris’s testimony in this regard is conclusory and entitled to little weight. 37 C.F.R. § 42.65(a).” slip op. at 38

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

    “In this case, both parties agree that “substantially encapsulating” includes “entirely surrounding or surrounding almost all except for minor areas that might be exposed.” This understanding is consistent with the lexicographic definition and the cited example provided in the ’348 patent. Ex. 1001, 6:7–13, 6:53–58. However, the lexicographic definition also defines this phrase as including the concept of “rigidly fixing together, and behav[ing] as a single component with respect to harmonic oscillation vibration.” Id. at 6:7–13. The cited example similarly reflects this concept. Id. at 6:53–58. Patent Owner argues that this portion of the definition is “not relevant” to the disputed issues in this proceeding. PO Resp. 29 n.1. However, that the parties do not dispute this aspect of the phrase’s meaning does not alter the proper construction of the phrase. Additionally, Patent Owner provides no persuasive reasoning or evidence to support this bare attorney argument. Thus, we construe “substantially encapsulating” in accordance with its lexicographic definition and cited example in the ’348 patent specification as “either entirely surrounding or surrounding almost all except for minor areas that might be exposed, such that the elements are rigidly fixed together and behave as a single component with respect to harmonic oscillation vibration.”” slip op. at 10

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

    “Stephan and Neal, however, explicitly teach that their housing and monolithic body, respectively, may be made from either a thermoset or an injection-molded thermoplastic material. See Ex. 1109 ¶ 41 (utilizing “any injection-molded thermoplastic,” or a “thermosetting synthetic material in a molding process”); Ex. 1104, 5:27–49 (“There are two types of phase change materials that will be most useful in practicing the invention: temperature activated and chemically activated. . . . The most preferred temperature activated phase change materials are thermoplastics. The preferred thermoplastic will become molten at a temperature at which it is injection-moldable. . . . An example of a phase change material that changes phases due to a chemical reaction, and which could be used to form the body 14, is an epoxy. Other suitable phase change materials may be classified as thermosetting materials.”). Thus, the cited prior art explicitly teaches that injection-molded thermoplastic materials are known alternatives to the chemically-activated epoxy resin disclosed by Zimmerman. Additionally, Neal explains that using injection-molded thermoplastic as an encapsulating material allows for appropriate thermal conductivity, as well as hermetic sealing. Ex. 1104, 6:26–46 (examples of thermally conductive thermoplastic resins), 9:5–20 (facilitating heat dissipation), 18:4– 10 (hermetically sealed). These are the same properties sought to be realized by Zimmerman’s epoxy resin sheath. Ex. 1103, 4:33–38 (explaining that the resin sheath “covers the non-insulated parts preventing moisture and liquid from contacting vital metal and moving parts . . . [and] is a liquid protector and heat transfer agent or heat conductive medium combined”); see also Ex. 1132 ¶ 78 (Dr. Trumper opining that a POSITA would have been motivated to use injection molded thermoplastic to form Zimmerman’s body to achieve the goals articulated by Zimmerman).” slip op. at 23

  Patent outcomesUS 7,928,348 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,928,348
• Aisin Seiki Co., Ltd. / Toyota Motor Corp. et al. v. Intellectual Ventures II LLCAll claims unpatentable
  PTAB · Dec 12, 2018 · IPR2017-01538 · APJ Amanda F Wieker · IPR · Final written decision

  Claims 24–27 are unpatentable as obvious over Konishi and over Umeda, Raible, and Neal; Petitioner did not show them unpatentable over Umeda and Stephan or Bramm and Watterson.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Based upon our review of the ’348 patent and the types of problems and solutions described in the ’348 patent and applied prior art, we determine that an ordinarily skilled artisan would have a bachelor’s degree in mechanical engineering, electrical engineering, chemical engineering, or an equivalent degree, and two years of experience in the design of electric motors and electromagnetic devices, including familiarity with the design, operation, materials, and fabrication of such devices, including their thermal and fluid characteristics.9 Although Patent Owner disputes whether an electrical engineering degree is sufficient educational experience for a POSITA, the cited testimony does not present any persuasive or specific basis upon which to determine that an electrical engineering degree, coupled with the cited experience, would be insufficient, as compared to a mechanical or chemical engineering degree. See Ex. 1002 ¶¶ 30–32 9 Although the parties present different characterizations of the areas of subject matter familiarity of a POSITA, we determine their content to be substantially the same. Compare Pet. 23, with PO Resp. 31–32. (Dr. Trumper opining that a POSITA may possess an electrical engineering degree); Ex. 2010 ¶¶ 23, 25 (Dr. Garris disputing only whether Dr. Trumper considered that the claims concern “electrically controlled fluid control devices,” but not discussing whether an electrical engineering degree would be sufficient); Ex. 1017 ¶¶ 26–27 (Dr. Toliyat opining that a POSITA of the ’348 patent may have “a degree in electrical engineering”); Ex. 1016, 22:12– 17, 23:14–21, 24:18–22 (Dr. Garris opining that a POSITA could have an electrical engineering degree).” slip op. at 17

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

    “In this case, both parties agree that “substantially encapsulating” includes “entirely surrounding or surrounding almost all except for minor areas that might be exposed.” This understanding is consistent with the lexicographic definition and the cited example provided in the ’348 patent. Ex. 1001, 6:7–13, 6:53–58. However, the lexicographic definition also clearly defines this phrase as including the concept of “rigidly fix[ing] together, and behav[ing] as a single component with respect to harmonic oscillation vibration.” Id. at 6:7–13. The cited example similarly reflects this concept. Id. at 6:53–58. Patent Owner argues that this portion of the definition is “not relevant” to the disputed issues in this proceeding. PO Resp. 29 n.1. However, that the parties do not dispute this aspect of the phrase’s meaning does not alter the proper construction of the phrase. Additionally, Patent Owner provides no persuasive reasoning or evidence to support this bare attorney argument. Thus, we construe “substantially encapsulating” in accordance with its lexicographic definition and cited example in the ’348 patent specification as “either entirely surrounding or surrounding almost all except for minor areas that might be exposed, such that the elements are rigidly fixed together and behave as a single component with respect to harmonic oscillation vibration.”” slip op. at 12

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “We have considered Patent Owner’s argument that stator can 51 and stator molded portion 5 may only be formed from the same material “if that common material is capable of handling the high temperature environment experienced by the stator can.” PO Resp. 36–37; Ex. 2010 ¶ 106. We disagree with this argument, and give little weight to Dr. Garris’s testimony upon which the argument depends, because it conflicts with Konishi’s disclosure. As discussed above, Konishi explains that the stator molded portion 5 and stator can 51 are “formed as a single unit.” Ex. 1003 ¶¶ 16, 38. Konishi does not place any restrictions upon this disclosure, and does not suggest that these components may only be formed as a single unit, if made with a certain material. Additionally, Konishi explains that the heat experienced by stator can 51 is mitigated by the working fluid that flows through heat transfer pipes 1 and flow paths 52, not by the particular material selected for a single unit stator molded portion and stator can. Id. ¶¶ 21–22. Dr. Garris does not identify any supporting basis for his testimony and, as such, we afford it little weight.” slip op. at 24

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

    “obvious to utilize injection-molded thermoplastic to form Konishi’s monolithic body, i.e., stator molded portion 5 and stator can 51. As discussed above, Konishi explicitly states that the stator molded portion and stator core are formed as a “single unit.” Ex. 1003 ¶¶ 16, 38. Moreover, Konishi discloses various types of thermoplastics that may be “used to seal the stator core, etc.” Id. ¶¶ 30–31. Konishi also discloses that injection molding is an exemplary method of sealing the stator core. Id. ¶ 37. Thus, we determine that a POSITA, aware of Konishi’s teachings that injection-molding and thermoplastic materials may be used to seal the stator core, would have found such use obvious. For example, we are persuaded by Dr. Trumper’s testimony that such materials were suitable, as taught by Konishi, and provided well-known benefits, e.g., high heat conductivity. Ex. 1002 ¶¶ 86–87; see also Reply 4 (discussing Dr. Garris’s deposition testimony, admitting that Konishi discloses that injection-molded thermoplastic may be used). We have considered Patent Owner’s argument, and Dr. Garris’s testimony, that “a POSITA would not use a thermoplastic for the stator can 51 because the material would soften or even melt if the temperatures in the vicinity of the windings 33 become too high.” PO Resp. 37 (citing Ex. 2010 ¶¶ 105–106). This argument, however, does not account for Konishi’s express teachings that thermoplastics may be utilized, as discussed above. Moreover, Konishi recognizes that heat is produced by windings 33, and explains that this heat is “removed to the outside by the working fluid that passes through the inside of heat transfer pipes 1.” Ex. 1003 ¶ 21; see also id. ¶ 22 (explaining that heat produced by coil 33 is removed by working fluid passing through flow paths 52). Thus, Konishi’s teachings are inconsistent with Dr. Garris’s testimony that “stator can 51 receives heat from windings 33, which are in close proximity, and it is so far away from the heat transfer pipes 1 and flow paths 52 that it receives little cooling from them compared to the stator molded portion 5.” Ex. 2010 ¶ 111. The record before us lacks sufficient evidence that problems associated with high heat are likely to occur in Konishi, given the heat reduction techniques employed to avoid this very problem. See Ex. 1003 ¶¶ 21–22; see also Ex. 1002 ¶ 87 (Dr. Trumper testifying that thermoplastics exhibit high heat conductivity). Accordingly, we disagree with Patent Owner’s arguments. Instead, for the reasons given, we agree with Petitioner that Konishi renders obvious the “injection molded thermoplastic” recitation of this limitation of claim 24.” slip op. at 27

  Patent outcomesUS 7,928,348 unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 7,928,348
• Donghee America, Inc. / Donghee Alabama, LLC v. Plastic Omnium Advanced Innovation And ResearchAll claims unpatentable
  PTAB · Dec 11, 2018 · IPR2017-01605 · APJ Christopher M Kaiser · IPR · Final written decision

  Claims 1–3, 7, 11, 12, and 14 are unpatentable: claims 1–3, 12, and 14 are anticipated by Linden, and claims 7 and 11 are obvious over Linden and Hata.

  RulingsFinal written decision

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

    “article whose surface has at least one empty or concave part.” Id. at 11 (citing Ex. 1001, 1:66–67; Ex. 1007 ¶ 15). Patent Owner agrees. PO Resp. 15. The ’253 patent states that “[t]he term ‘hollow body’ is understood to mean any article whose surface has at least one empty or concave part.” Ex. 1001, 1:66–67. Where an inventor defines specific terms used to describe an invention, we will give effect to those definitions, as long as they are set out “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). Here, the phrase “is understood to mean,” as used in the ’253 patent, signals that the inventor presents a clear, deliberate, and precise definition. Accordingly, we interpret “hollow body” as having the definition given it in the ’253 patent, “any article whose surface has at least one empty or concave part.”” slip op. at 6

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

    “supporting its proposed construction of “incorporate” as “insert.” First, Petitioner argues that the language of the ’253 patent requires a construction of “incorporating” as encompassing “inserting” rather than as limited to “attaching.” Reply 2–4. Both parties argue that the “incorporating” recited in the challenged claims must occur before the mold closes to form the hollow body. PO Resp. 16; Reply 2–3. We agree. Ex. 1001, 6:2–14 (“. . . after said step of incorporating, closing said mould . . .”). Thus, it is important to note the processes that the ’253 patent describes as occurring before, during, and after mold closure. Because “incorporating” must occur before mold closure, the process of “incorporating” may not be limited to any process that the patent describes as occurring during or after mold closure. Petitioner is correct that the ’253 patent describes a process in which a preassembled structure for supporting an accessory “may . . . be fastened by welding to the wall of the hollow body, upon closing the mould,” i.e., during, not before, mold closure. Ex. 1001, 4:23–30. Thus, the language of the ’253 patent does not support construing the term “incorporating” as limited to “attaching.” Petitioner also argues that both parties agreed in the related infringement suit in District Court that the proper construction of “incorporating” under the Phillips standard, used in that forum, was “inserting.” Reply 7–8 (citing Ex. 1010, at Ex. A, 4). Specifically, in that litigation, Patent Owner agreed that the correct construction of “incorporating at least one of an accessory or a duct within the hollow body” was “inserting an accessory or duct into the hollow body.” Ex. 1010, at Ex. A, 4. Here, we apply the broadest-reasonable-interpretation standard. 37 C.F.R. § 42.100(b) (2016). “The broadest reasonable interpretation of a claim term may be the same as or broader than the construction of a term under the Phillips standard. But it cannot be narrower.” Facebook, Inc. v. Pragmatus AV, LLC, 582 F. App’x 864, 869 (Fed. Cir. 2014) (non-precedential). Here, for the term “incorporating,” Patent Owner’s proposed broadest reasonable interpretation (“attaching”) is narrower than the Phillips construction Patent Owner has advanced (“inserting”). Thus, “attaching” cannot be the broadest reasonable interpretation of “incorporating.” Other than Patent Owner’s proposed “attaching” construction, the only construction the parties have proposed either in this case or in the related District Court case is Petitioner’s proposed “inserting” construction. PO Resp. 15–20 (discussing only “inserting” and “attaching” constructions); Reply 2–9 (Petitioner arguing in favor of “inserting”); Ex. 1010, at Ex. A, 4 (both parties proposing “inserting”). The ’253 patent supports such a construction, because it describes at least some of its embodiments as involving only insertion of an object between the sheets that will form the hollow body before mold closure. Ex. 1001, 4:23–30. Accordingly, for the foregoing reasons, we adopt Petitioner’s proposed construction of “incorporating” as “inserting.”” slip op. at 10

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “Finally, Patent Owner directs us to the testimony of Professor Tim Osswald as support for its view that “incorporate” should mean “attach.” PO Resp. 16 (citing Ex. 2001 ¶¶ 40–42). In relevant part, this testimony states that, “[a]fter reading the specification of the ’253 patent, one of ordinary skill in the art would understand and interpret the word ‘incorporating’ to mean ‘fastening’ or ‘attaching’ so that the accessory or duct becomes part of the hollow body.” Ex. 2001 ¶ 42. Professor Osswald does not cite any evidence in support of his testimony. “[C]onclusory, unsupported assertions by experts as to the definition of a claim term are not useful.” Phillips v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005) (en banc). Accordingly, we give little weight to Professor Osswald’s statement regarding the proper construction of “incorporate.” See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he [PTAB] is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations . . . .” (citations omitted)).” slip op. at 9

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

    “preform which has at least one opening for that purpose, to be applied to the inside surface of the wall of the expanded hollow body.” Id. at 3:62–4:3. Patent Owner argues that this teaching is insufficient to disclose attaching the surge cup to the wall of the hollow body before the mold closes. PO Resp. 23–24. We agree that Linden does not teach attaching its accessory to the inside wall of the fuel tank before the mold closes around the preform. Instead, in Linden, the mold halves are closed around the preform and the mandrel, and “a suitable blowing agent . . . is introduced under pressure” through the mandrel, causing the preform to expand to press “against the inside wall defining the mold cavity,” and only then is the holding means for the accessory displaced to be brought into contact with the inner wall of the expanded preform, welding the holding means to the wall. Ex. 1003, 7:27–55, 8:11–29, Figs. 1–3. But, as discussed above, we disagree with Patent Owner about the proper construction of “incorporating” in the challenged claims. Claim 1 requires only that an accessory or a duct be “incorporat[ed] . . . within the hollow body” before mold closure occurs, and we construe “incorporating” to mean “inserting,” without requiring “attaching.” Thus, it is unimportant that Linden fails to teach attaching the surge cup to the wall before mold closure. All that is required is that Linden disclose inserting the surge cup into the preform before mold closure, and Linden does disclose this. Id. at 3:62–4:3, 7:27–49, Figs. 1–3. The next question is whether Linden discloses “after said step of incorporating, closing [the mold] in a way which eliminates any interface between said at least one of said accessory or said duct and an external atmosphere outside of the hollow body.” As discussed above, Linden discloses closing the mold halves after placing the additional body within the preform. But Linden discloses that “[a]t its lower end the preform 28 is pressed around the mandrel 14 by virtue of closure of the mold halves 10a and 10b.” Id. at 7:40–42, Fig. 2. Because mandrel 14 is hollow, id. at 6:35–39; 6:46–54, it is not completely clear that closure of Linden’s hollow body around mandrel 14 necessarily eliminates any interface between the additional body inside Linden’s hollow body and the atmosphere outside the hollow body. On the other hand, the closure of the mold described in the ’253 patent occurs with blowing nozzle 6 “positioned between the two parts of the [mold],” and “blowing air is injected under pressure via the nozzle,” which is quite similar to the use of hollow mandrel 14 in Linden. Ex. 1001, 5:50–57. Given the similarity between Linden’s method and the method described in the ’253 patent, we determine that Petitioner has shown by a preponderance of the evidence that Linden discloses the limitation of claim 1 requiring the step of, “after said step of incorporating, closing [the mold] in a way which eliminates any interface between said at least one of said accessory or said duct and an external atmosphere outside of the hollow body.” The final question with respect to claim 1 is whether Linden discloses that the additional body incorporated within the hollow body “is supported by a preassembled structure which comprises at least one device configured to anchor said preassembled structure to an internal wall of the hollow body.” Petitioner argues that Linden’s “[h]olding means 24 is a preassembled structure” in which “leg members 44, 45” have “enlarged foot portion[s] 36.” Pet. 18 (citing Ex. 1003, 9:23–34). We agree. “[H]olding means 24 . . . substantially comprises first and second support or leg members 44, 45,” and “support or leg members 44, 45 are each provided with an enlarged foot portion 36 of substantially plate-like configuration.” Ex. 1003, 9:23–34. Even if Linden’s holding means 24 were not in the aggregate the recited “preassembled structure,” each leg member 44, 45, taken together with its respective foot portion 36 is. Ex. 1001, 4:26–28 (describing a “preassembled structure” as “for example, an arm provided with a tab for fastening to the wall of the hollow body”). Linden’s “foot portions 36 are pressed against the inside surface, which is still hot and thus plastic, . . . of the hollow body . . . thereby to produce a welded joint between the foot portions 36 and the inside surface.” Id. at 9:34–42. Petitioner has shown by a preponderance of the evidence that Linden discloses the limitation of claim 1 requiring that the accessory or duct be “supported by a preassembled structure which comprises at least one device configured to anchor said preassembled structure to an internal wall of the hollow body.”” slip op. at 19

  Patent outcomesUS 7,166,253 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 7,166,253
• Wockhardt Bio AG v. Janssen Oncology, Inc.Rehearing denied
  PTAB · Dec 3, 2018 · IPR2016-01582 · APJ Kristina M Kalan · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, finding no overlooked or misapprehended matter in its decision holding claims 1–20 unpatentable.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. THE REQUEST FOR REHEARING In pertinent part, 37 C.F.R. § 42.71(d) states: The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. Thus, a request for rehearing is not an opportunity merely to disagree with the Board’s assessment of the arguments or weighing of the evidence, or to present new arguments or evidence.” slip op. at 2

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Patent Owner now presents a new argument that we misapprehended the teachings of the prior art with respect to claims 4, 11, 19, and 20. Req. 12–14. Patent Owner, however, does not point out where this matter was previously raised. Because Patent Owner has not previously raised any of its arguments presented in the Request, we are not permitted to consider its arguments now. 37 C.F.R. § 42.71(d). Moreover, we did not overlook Patent Owner’s arguments regarding these claims; rather, we considered and adopted Petitioner’s arguments regarding these claims. Dec. 45; cf. Cutsforth, Inc. v. Motive Power, Inc., 636 F. App’x 575 (Fed. Cir. 2016) (nonprecedential). Patent Owner’s failure to argue specifically against these claims during trial does not permit Patent Owner to now present arguments in this regard.” slip op. at 5

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “In our Final Written Decision, in connection with our assessment of motivation to combine Sartor with Gerber and O’Donnell, we addressed the disputed portion of Dr. Godley’s testimony directly. Dec. 26 (“Fourth, Patent Owner argues that Petitioner’s expert agrees that prednisone was not known to have anti-cancer treatment effects in prostate cancer patients.”) There, we agreed with Petitioner that Dr. Godley’s interpretation of Sartor was “consistent with Petitioner’s position regarding Sartor, i.e., that prednisone has its own anti-cancer effect.” Id. (citing Ex. 1002 ¶ 116; Ex. 2162, 61:15–62:17). Patent Owner’s disagreement with our analysis is not a proper basis for a rehearing request. Regarding the Board’s consideration of Sartor’s credibility, we evaluated the evidence and testimony before us to conclude that, despite the fact that Sartor was a chart review, it is a “peer-reviewed article published in a reputable journal” and its format did not undercut its teachings. Dec. 24. Regarding the Board’s use of the word “palliative,” we disagree that such use constitutes a new theory advanced by the Board. Req. 7–8. Rather, we used the term “palliative” three times in the Final Written Decision—once to accurately quote the language used by Dr. Godley in his Declaration (Dec. 26 (citing Ex. 1002 ¶ 116)), once to accurately quote Dr. Godley’s testimony (Dec. 26–27 (citing Ex. 2162, 66:1–10, 66:17–67:1), and once in our discussion of claim construction (Dec. 33). None of these instances advances a new theory. Although we noted that Dr. Godley stated that prednisone could be prescribed for palliative treatment in reconciling that statement with our claim construction (id. at 26–27), we relied on Petitioner’s arguments in chief regarding reasons to combine Gerber, O’Donnell, and Sartor in reaching our ultimate determination of unpatentability. Id. at 11–13.” slip op. at 3

  § 103 obviousness
  Patents in suitUS 8,822,438
• Shenzhen Kean Silicone Product Co., Ltd. v. Pkoh Nyc, LLCSome claims unpatentable
  PTAB · Dec 3, 2018 · IPR2017-01327 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–7, 10–13, 20–22, 24, 26, 28–32, and 35–38 are unpatentable as obvious; claim 14 was not shown unpatentable over Cho.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Person of Ordinary Skill in the Art Petitioner’s expert, Mr. Goldman, proposes that a person of ordinary skill in the bottle/container field as of the time of the filing of the application that became the ’036 patent “would have a bachelor’s degree (or equivalent) in mechanical engineering and at least one or two years’ experience developing container technology.” Ex. 1014 ¶ 4. Patent Owner does not dispute Petitioner’s proposal, and based on the final record, we adopt it for purposes of this Decision.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningNo construction neededDecided for petitioner

    “The Specification of the ’036 patent describes “[t]he elastomeric material is . . . of an appropriate durometer, such as 40 Shore A, to make the squeeze bulb 200 substantially deformable yet resilient,” and the elastomeric material is preferably silicone. Ex. 1001, 2:54–63. Only the claimed wall portion of the receptacle is claimed to be “resiliently deformable.” Id. at 5:9–10. Nothing in the claim, however, precludes or requires any other portion of the receptacle (comprised of elastomeric material) from also being resiliently deformable. Id. at 4:47–48. Notably, the receptacle is claimed to be “flexible and resilient.” Id. Although the “flexible and resilient” receptacle and its wall being “resiliently deformable” are not necessarily identical, this distinction appears to be minor considering the written description of the ’036 patent. Based on the foregoing, we give each of these claim terms their plain and ordinary meaning as understood by a person or ordinary skill in the art. The surrounding claim language for each claim limitation focuses the scope of these terms such that any interpretation we could provide would not be as helpful in understanding the terms as the surrounding claim language. We determine that no terms require express construction for the purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedOther

    “6 In our decision, we give little weight to Petitioner’s evidence of “scores of popular baby bottles currently on the market,” because the design of these new bottles does not indicate the state of the art at the time the ’036 patent was filed. Further, Petitioner has failed to provide any corroborating testimony related to these new bottles—recent advertisements do not convince us of what a person of skill in the art would have considered at the time of filing. See Pet. Reply 11 (emphasis added) (citing Exs. 1022, 1023, 1024). We likewise give little weight to Petitioner’s uncorroborated article (Ex. 1026) from Wikipedia concerning “Baby bottle.” The record before us does not establish the origin and scientific basis for this evidence, and thus, we weigh Mr. Goldman’s testimony (Ex. 1021 ¶ 13) based on this evidence in a similar manner. See 37 C.F.R. § 42.65(a); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,763 (“Affidavits expressing an opinion of an expert must disclose the underlying facts or data.”). This sentence, standing alone, supports Mr. Fletcher’s conclusion that “an elastomeric, flexible silicone” could be used in the body of Cho’s bottle. See Ex. 1014 ¶ 30. Further, we find persuasive Petitioner’s arguments, supported by the testimony of Mr. Fletcher, that “silicone is primarily known for its elastic properties, and has been widely used in medical applications, including implants and storage containers, due to its chemical inertness, high heat resistance, flexibility and resistance for at least 60 years.” Pet. 30 (citing Ex. 1014 ¶ 34). Petitioner also supports its argument as to the suitability of silicone in consumer products, including in baby bottles, with a 1991 New York Times article that explains the elastomeric properties of silicone. Pet. 12; Ex. 1018, 2 (describing “rubbery silicone”), id. at 3 (“When baby gets a bottle these days, the nipple is a rubbery version of silicone.”). The fact that silicone could also possess other properties, or hardness, does not dissuade us from the determination that Cho, as a whole, teaches using a soft, resilient silicone in the body of the bottle.” slip op. at 20

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “At the outset, Mueller is analogous art and Patent Owner’s arguments to the contrary flip the analysis from focusing on the problem faced by the inventor of the ’036 patent to the “specific problem(s) found in Cho’s baby bottle.” First, Cho and Mueller are in the same field of endeavor as the claimed invention—dispensing containers—as admitted by Patent Owner. See PO Resp. 36. We need not address the second portion of the analogous art test, which focuses on whether the prior art “is reasonably pertinent to the problem with which the inventor was concerned.” In re Kahn, 441 F.3d 977, 986–87 (Fed. Cir. 2006). We do note, however, that the parties have both misapplied this second portion of the analysis. This analysis is focused on the problem faced by the inventor of the ’036 patent, not necessarily the problems addressed in the prior art references. Because neither party sufficiently addresses the problems faced by the inventor of the ’036 patent, and because Mueller and Cho are in the same field of endeavor as the claimed invention, we need not address the second portion of the analogous art test.” slip op. at 39

  Patent outcomesUS 7,959,036 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,959,036
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

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

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

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

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213

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.