• 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
• 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
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01374 · 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 because Kurrle and Queen 1990 were not prior art …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “with respect to the ’213 patent. See Pet. 12–13; Prelim. Resp. 17–18; PO Resp. 17–18. 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. 10–11. Petitioner does not contest this definition in its Reply and we find no reason to revise our earlier determination. We further note that the prior art itself demonstrates this 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 ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 11

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

    “Patent Owner’s proposed construction derives from the ’213 patent’s definition of consensus sequence as “refer[ing] to an amino acid sequence which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Ex. 1001, 11:32–38. In the context of the patent as a whole, however, we do not understand the term to require a consensus of “all” human immunoglobulins in the literal sense because the embodiments in the patent were generated using the most common residue at each position identified in Kabat 1987.11 See id. at 10:34–63, 11:55–60; Ex. 2016 ¶¶ 25– 26. 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. See PO Resp. 47. Moreover, at oral argument, Patent Owner did not contest Petitioner’s assertion 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.” Tr. 15:4–16:4.12 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

  • Prior constructionDecided for patent owner

    “We previously stated that the language of claim 63, “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” IPR2017-01488, Paper 27 at 10–12. Patent Owner does not dispute this interpretation. See PO Resp. 19. Petitioner argues that the recited reduction in immunogenicity is both an inherent aspect of the claimed humanized antibodies, and “the stated goal of all humanization projects, including that of Queen 1990 and Kurrle.” Pet. Reply, 28, 43. Petitioner also contends that the term is not a claim limitation and “simply a statement of the intended result of the claimed compositions,” but, nevertheless, states: “For the purpose of the present petition only, Petitioner will assume that the preambles are limiting.” Pet. 13 n.3. On balance, we see no need to 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. Nevertheless, to the extent Petitioner is correct that the preambles should be accorded no weight, such a determination would not alter the outcome of this proceeding.” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

    “The ’213 patent issued from application number 08/146,206 (“the ’206 application”), which is an application that entered the national stage on November 17, 1993, from a PCT application filed on June 15, 1992. Ex. 1001, (21), (22), (86). The ’206 application is also a continuation-in-part of the ’272 application, filed on June 14, 1991. Id. at (63). Kurrle was published on December 19, 1990 (Ex. 1071, (43)), and Queen 1990 was published on July 26, 1990 (Ex. 1050, (43)), both of which predate the earliest possible priority date, June 14, 1991, shown on the face of the ’213 patent. Accordingly, Petitioner has satisfied its initial burden of showing that Kurrle and Queen 1990, on their face, qualify as prior art to the challenged claims. We next consider whether Patent Owner has antedated these references.” slip op. at 18

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01373 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 are unpatentable; claims 65, 72, 75–77, and 79 are not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedOther

    “Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 10 (citing Pet. 12; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition 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.” Id. at 10–11. During trial, the parties did not dispute this finding. Having considered the complete record developed at trial, we see no reason to change our assessment. We further note that, in this case, 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 regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 10

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

    “In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human 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.” Dec. 7; Ex. 1001, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. Indeed, counsel for Patent Owner acknowledged that the term refers to “all reasonably available[,] all known at the time of the invention.” Tr. 47:21–48:5. Dr. Wilson, the expert witness for Patent Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 207 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1140, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1142, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1142, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1140, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1142, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”). Thus, although we reiterate our previous construction of “consensus” slip op. at 11

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

    “For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13

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

    “combination of Queen 1989 and the PDB database, together with the knowledge of an ordinary artisan, teaches or suggests each limitation of claims 12, 63, 66, 67, 71, 73, 74, and 78, and that a person of ordinary skill in the art would have had a reason to combine the references, and would have had a reasonable expectation of producing humanized antibodies with the substitutions and properties recited in those claims. We further determine that evidence of secondary considerations is not sufficient to outweigh the strong evidence of obviousness associated with the other Graham factors. As a result, we conclude that Petitioner has established by a preponderance of the evidence that claims 12, 63, 66, 67, 71, 73, 74, and 78 are unpatentable over Queen 1989 and the PDB database.” slip op. at 37

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Emerson Electric Co. v. Sipco, LLCSome claims unpatentable
  PTAB · Nov 28, 2018 · IPR2017-00359 · APJ Bryan F Moore · IPR · Final written decision

  Claims 32, 34, 37–38, 55–57, and 59 are unpatentable over Cunningham; claims 1, 3–8, 11–14, 24–31, 36, 42, 43, 46–49, 51–54, and 60–64 were not shown unpatentable.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “This argument is conclusory and not supported by sufficient evidence. Moreover, the stated conclusion is vague with respect to the limitation at issue. Petitioner argues that “the node 18 must translate messages” (id. (emphasis added)), but does not explicitly argue that all three recited pieces of information—“the select information, the transmitter identification information, and transceiver identification information”—must be translated. Even assuming Mason’s node must translate all three recited pieces of information, Petitioner does not show that all such translated pieces of information must be further transmitted to the AMR server over the WAN. In particular, Petitioner does not show that transceiver identification information would have to be further transmitted.” slip op. at 21

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

    “Moreover, we agree with Petitioner that such a construction is “non- specific, vague and unhelpful” in the context of the ’692 patent. Reply. 16. Patent Owner’s construction limits “low power” to signals having a “limited transmission range,” but provides no guidance of what “limited” means, or what its boundaries might be. Petitioner argues correctly that Patent Owner’s construction fails to address questions its proposed construction raises, such as, what a ‘limited’ transmission range means and how ‘limited’ the range must be (i.e., what the range’s distance should be), whether the transmission range depends on the particular system or application, and whether other factors should be considered in determining whether the transmission range is limited.” slip op. at 14

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

    “Notably, Petitioner says these contentions are “further evidence” but does not explain how this evidence is to be used to buttress Cunningham’s disclosure or how it is to be combined with Cunningham’s disclosure. Specifically, given the limited contentions in the Petition detailed above, Petitioner does not explain how Energy Management Services or the “routines” described in the Provisional send control signals from the computer to the actuator as required by the claims. For example, even if we to accept that the “Williams Network Control Center” creates control signals as required by the claim Petitioner has not explained how those signals are translated from network transfer protocol to RF signals and then translated to an analog signal that can be used at an actuator. Even though the ’978 Provisional is allegedly incorporated by reference, an obviousness determination still requires--“[w]hether a [obviousness challenge] is based on combining disclosures from multiple references, combining multiple embodiments from a single reference, or selecting from large lists of elements in a single reference[--] a motivation to make the combination and a reasonable expectation that such a combination would be successful, otherwise a skilled artisan would not arrive at the claimed combination.” In re Stepan Co., 868 F.3d 1342, 1346 n. 1 (Fed. Cir. 2017); c.f. Boston Sci. Scimed, Inc. v. Cordis Corp., 554 F.3d 982, 991 (Fed. Cir. 2009) (finding obviousness shown despite fact that “all of the limitations are found in two separate embodiments pictured side by side in the patent, not in one embodiment” because the party showed motivation to combine and reasonable likelihood of success). Additionally, “there must be evidence presented on the obviousness of the claim as a whole.” Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331, 1337 (Fed. Cir. 2015) (citing KSR, 550 U.S. at 420, 127 S.Ct. 1727); see also Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 903 F.3d 1310, 1352 (Fed. Cir. 2018) (“The determination of obviousness is made with respect to the subject matter as a whole, not separate pieces of the claim”). Here, the “routines” described in the ’978 Provisional work differently than the “utility prices” embodiment of Cunningham. Petitioner has not explained how those would work together to meet the claim limitations.” slip op. at 30

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

    “Patent Owner’s argument is inapposite, as it is premised on reading a limitation into the claims, namely that the information encoded in the RF signal must be translated in real time. Further, we agree with Petitioner, that even under such an erroneously narrow construction, Cunningham would meet the limitation. In that regard, Petitioner argues that, “although Cunningham discloses sending cumulative data readings, individual signals from the sensor are identified by the gateway and this information is then transmitted (with transmitter identification information) to a computer on the WAN.” Reply 6 (citing Ex. 1046 ¶¶31–32; Ex. 1004, 31:6–28). Petitioner argues, and we are persuaded, that “Cunningham explains that the ‘most current cumulative reading’ is the current absolute ‘reading’ (i.e., information signal) from the sensor (Ex. 1004, 13:44–46) and that two cumulative readings can be used to ‘interpolate’ and ‘recover’ a missed reading (i.e., a signal from the sensor).” Reply 7 (citing Ex. 1004, 13:44–56; 31:6–27; Pet. 75; Ex. 1002 ¶¶115, 152; Ex. 1046 ¶32). We are persuaded that Cunningham discloses this limitation. Lastly, claim 32 also recites “a computer configured to execute at least one computer program that formats and stores select information responsive to the electrical signal for retrieval upon demand from a remotely located device.” To meet this limitation, Petitioner accurately points out that “Cunningham discloses that[,] in response to receiving information from the sensor interface module through the data collection modules, the host module compiles the information into a user specified readable format and stores it for later retrieval upon demand from a customer computer or workstation.” Pet. 83 (citing Ex. 1004, 7:19–27, 44:12–41, 44:53–64, 46:44–61, 47:44–54, Ex. 1002 ¶¶138–140). Patent Owner does not contest that Cunningham discloses “a computer configured to execute at least one computer program that formats and stores select information responsive to the electrical signal for retrieval upon demand from a remotely located device.” See PO Resp. 22–29, 41–46. We are persuaded that Cunningham discloses this limitation. For the forgoing reasons, Petitioner has shown by a preponderance of” slip op. at 37

  Patent outcomesUS 6,437,692 mixed
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 6,437,692

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.