• Mobile Tech, Inc. v. Invue Security Products Inc.Rehearing denied
  PTAB · Dec 4, 2018 · PGR2018-00004 · APJ Stacey G White · PGR · Rehearing

  The Board denied rehearing and left in place its denial of institution because Petitioner did not show an abuse of discretion in finding claims 1–45 supported and enabled.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “III. STANDARD OF REVIEW “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). When requesting rehearing of a decision, the challenging party must identify specifically all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in the record. Id. When considering a request for rehearing of a decision on whether to institute trial, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “An abuse of discretion occurs where the decision is based on an erroneous interpretation of the law, on factual findings that are not supported by substantial evidence, or represents an unreasonable judgment in weighing relevant factors.” Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005) (citing Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004)). We address Petitioner’s arguments with these principles in mind.” slip op. at 3

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

    “’472 patent is eligible for post-grant review. Dec. 16. Here, eligibility for post-grant review depends on the effective filing date of the challenged claims. When determining the effective filing date, a claim is entitled to the benefit of an earlier filing date when an earlier application discloses the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode).” See id. at 6 (citing US Endodontics, LLC v. Gold Standard Instruments, LLC, Case PGR2015- 00019, slip. op. at 7 (PTAB Dec. 28, 2016) (Paper 54)). The ’472 patent was the latest in a chain of continuation applications that dates back to U.S. Patent Application No. 13/169,9685 (“968 Application”), which was filed on June 27, 2011. Ex. 1001, at [63]. We previously determined that the 968 5 There are other applications in this chain, but none of those applications are relevant to the issues presented here and thus, we do not address those applications. Application and the ’472 patent have substantially identical specifications and figures. See Dec. 7 (finding that the 968 Application and the patent application from which the ’472 patent issued are substantially identical). We thus determined that we were able to “analyze the ’472 patent’s eligibility for post grant review through a discussion of Petitioner’s arguments as to written description support in the ’472 patent.” Id. at 8. We then found that Petitioner failed to establish that the challenged claims lack written description support or are not enabled. See id. at 12, 15–16.” slip op. at 4

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “The ’472 patent expressly recites: Actuation of activation switch 85 causes logic control circuit 18 of programming station 3 to randomly generate a unique security code (i.e. SDC) that is transmitted via communication circuit 20 to communication circuit 79 of programmable key 5, which in turn stores the randomly generated SDC in security code (SDC) memory 81 of the key . . . . [T]he SDC initially provided by the programming station 3 is randomly generated and is unique to that programming station and always remains with that programming station for subsequent use. Thus, the SDC initially generated always stays with the programming station 3 and is subsequently programmed into one or more programmable keys 5. Ex. 1001, 9:23–43 (emphases added); see also id. at 10:6–12 (“[T]he particular programming station 3 of the retail store [is] used to program the key with the SDC.”). The ’472 patent also discloses that the programming station “reprogram[s] or refresh[es] the SDC into the key” after the programmable key times out, which occurs after a predetermined period elapses from the time that the programmable key was last programmed or refreshed. See e.g., id. at 12:63–13:8. Specifically, the programming station performs a “handshake” with the key “to determine whether the key has not previously been programmed with a SDC (i.e. a ‘new’ key), or is an authorized key that is being presented to the programming station a subsequent time to refresh the SDC,” and once a proper “handshake” is completed, the programming station “permits the SDC generated by the logic control circuit and/or stored in the memory to be transmitted . . . [to] the programmable electronic key.” Id. at 16:4–19. Thus, the programming station is responsible for generating the SDC and transmitting it to the programmable key. More to the point, the ’472 patent discloses that “the programming station will deactivate a SDC stored in the SDC memory of a key if an incorrect SDC is encountered when the programming station is attempting to reprogram or refresh the key.” Id. at 13:13–17 (emphases added). This contradicts Petitioner’s proposition that a key programmed with one SDC from a first programming station can then program that same SDC into a second programming station. The ’472 patent expressly teaches how to deal with a situation in which a second programming station encounters an incorrect SDC in the memory of a key: it deactivates the SDC stored in the key.” slip op. at 7

  § 112 disclosure
  Patents in suitUS 9,659,472
• 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
• Amerigen Pharmaceuticals Limited / Argentum Pharmaceuticals LLC v. Janssen Oncology, Inc.Rehearing denied
  PTAB · Dec 3, 2018 · IPR2016-00286 · APJ Kristina M Kalan · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving claims 1–20 unpatentable because the request did not show that the Board overlooked or misapprehended matters.

  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 petitioner

    “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. 14–15. 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. 43; 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 7

  None
  Patents in suitUS 8,822,438
• Mylan Pharmaceuticals Inc. / Actavis Laboratories FL, Inc. et al. v. Janssen Oncology, Inc.Rehearing denied
  PTAB · Dec 3, 2018 · IPR2016-01332 · APJ Kristina M Kalan · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving claims 1–20 unpatentable under the Final Written Decision.

  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

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

    “Decision, particularly noting Patent Owner’s argument that “there is no prior art evidence that ketoconazole causes mineralocorticoid excess.” Dec. 17 (citing PO Resp. 18). We also considered Petitioner’s countervailing evidence (id. at 17–18), Patent Owner’s Identification of New Arguments and Evidence in Petitioner’s Reply (Paper 65), and Petitioner’s reply to the same (Paper 74). We also noted in our Final Written Decision that Petitioner’s motivation to combine appeared to be premised on the adverse effects caused by reduced production of cortisol. Dec. 13. We also relied, in the Final Written Decision, on Dr. Garnick’s testimony that CYP17 inhibitors undesirably suppressed the production of cortisol, which is necessary for other biochemical cycles in the body, and which led to adverse side effects. Id. at 12–13 (citing Ex. 1002 ¶¶ 42, 44, 58). We also relied on Dr. Garnick’s testimony that “in light of steroid synthesis inhibitors’ known effects on the adrenal pathways,” one of ordinary skill in the art “would have been motivated to administer a glucocorticoid with administered abiraterone acetate to counteract expected endocrine disruptions.” Dec. 17 (citing Ex. 1097 ¶¶ 21–66). We expressly addressed Petitioner’s arguments and evidence, Patent Owner’s arguments and evidence, and the respective testimony on this issue, and did not overlook Patent Owner’s testimony or other testimony regarding the relationship between ketoconazole and mineralocorticoid excess. Nor are we persuaded, given our consideration and analysis of the testimony and other evidence, that we misapprehended the import of this testimony and evidence, or Petitioner’s reliance on the same for Petitioner’s arguments to support motivation to combine the reliedupon references.” slip op. at 3

  • Strike new argumentNew argument disregardedDecided for petitioner

    “under 35 U.S.C. § 282. Patent Owner further argues that the Board overlooked or misapprehended that evidence that skilled artisans evaluated O’Donnell and nevertheless proceeded to undertake studies based on abiraterone acetate monotherapy. Req. 13. Patent Owner, however, does not point us to where these argument were raised previously. 37 C.F.R. § 42.71(d). Therefore, Petitioners did not have an opportunity to respond to these issues. Nor did Patent Owner previously address the question of why the presumption of validity in 35 U.S.C. § 282 controls inter partes review proceedings in light of the statement in 35 U.S.C. § 316(e) that “In an inter partes review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” Accordingly, because Patent Owner does not demonstrate that these arguments were raised previously, and because we cannot be assured that Petitioner has had any opportunity to respond, we do not consider these arguments in our present order.” slip op. at 6

  § 103 obviousness
  Patents in suitUS 8,822,438
• Fujifilm Corporation v. Sony CorporationNo claims unpatentable
  PTAB · Dec 3, 2018 · IPR2017-01390 · APJ Jeffrey W Abraham · IPR · Final written decision

  The Board held that claims 1–18 were not shown unpatentable because the prior art did not establish the claimed volume concentration in the formed magnetic layer.

  RulingsFinal written decision

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

    “define the term “volume concentration.” In the context of the ’331 patent, “volume concentration” refers to the volume concentration of the magnetic particles in the formed magnetic layer.” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(1) a bachelor’s degree in materials science, physics, electrical engineering, mechanical engineering, chemistry, or a closely related field, and at least five years of experience in the field of magnetic recording, or (2) a Master’s degree or higher in materials science, physics, electrical engineering, mechanical engineering, chemistry, or a closely related field, with an emphasis in magnetic recording, and at least three years of experience in the field of magnetic recording. Pet. 12; Ex. 1017 ¶ 60. Although Patent Owner does not expressly define the appropriate level of skill in the art in the Patent Owner Response or its Supplemental Response, Patent Owner’s declarant, Dr. Bain, presents a definition of a person of ordinary skill in the art in his declaration that is nearly identical to Petitioner’s definition. Ex. 2001 ¶ 44. In view of this, for purposes of this Decision, we adopt Petitioner’s definition of a person of ordinary skill in the art.” slip op. at 16

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

    “information, is not sufficient evidence to establish that Mori discloses the “volume concentration” recited in claim 1. Patent Owner does not dispute that there is some magnetic alloy present “in the magnetic layer” of Mori. The relevant question, however, is how much and how Mori’s disclosed values were determined. Unlike the term “volume concentration,” for which the parties offered undisputed evidence regarding accepted meanings of the term in the art (i.e., packing fraction and pigment volume concentration), we have not been directed to similar evidence regarding the phrase “fill rate”/“filling rate” in Mori. Thus, although Mori states “[t]he filling rate by volume of the strongly magnetic alloy powder in the magnetic layer can be equal to or higher than 30%” (Ex. 1003 ¶ 11 (emphasis added)), Petitioner has not offered sufficient evidence demonstrating that the term “filling rate” in Mori refers to a final product-based value. As a result, we find that this language in Mori does not establish, by a preponderance of evidence, that Mori discloses the “volume concentration” recited in claim 1.” slip op. at 21

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “For all of the foregoing reasons, we find that Petitioner has failed to demonstrate, by a preponderance of evidence, that the combined teachings of Aonuma and Mori disclose or suggest “[a] dual layer magnetic recording medium comprising . . . a magnetic upper recording layer formed over [a] lower support layer, the magnetic upper recording layer comprising a volume concentration of at least about 35% of a primary magnetic particulate pigment,” as recited in independent claims 1 and 16. Ex. 1001, 11:14–20, 12:25–31. Claims 2–15, 17, and 18 depend from claim 1 or claim 16, and, therefore, include the “volume concentration” limitation of claims 1 and 16. As a result, we find that Petitioner has failed to demonstrate that Aonuma and Mori disclose or suggest each limitation of claims 1–18, and, therefore, has not demonstrated by a preponderance of evidence that claims 1–18 are unpatentable as obvious over Aonuma and Mori.” slip op. at 26

  Patent outcomesUS 7,115,331 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 7,115,331
• 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
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01488 · 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

  • 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 board ownDecided for patent owner

    “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.” slip op. at 13

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

    “humanized” (claims 1, 30, 62–64, 66, 79, 80); “and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of” (claims 1, 30, 62, 63, 66, 79, and 80); “numbering system set forth in Kabat” (claims 1, 30, 62, 63, 66, 79, and 80); and “up to 3-fold more” (claim 65). Patent Owner does not dispute Petitioners’ proposed constructions, but asserts that “[n]o construction of those terms is necessary.” Prelim. Resp. 19; PO Resp. 19. On the present record, we agree with Patent Owner that the terms identified by Petitioners need not be construed to resolve the issues presently before us. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (instructing that claim terms need only be construed to the extent necessary to resolve the controversy). slip op. at 15

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “substitutions, most being unrepresented in any ’272 embodiment.” Pet. Reply 8. We do not find Petitioners’ argument persuasive in light of Patent Owner’s evidence showing that the ’272 application discloses, inter alia, each of the framework substitutions recited in claims 12, 42, 60, 65, 71, 73– 74, and 79 (collectively, 66L, 71H, 73H, 78H, 93H), along with “a generalized scheme for humanizing any non-human antibody.” See PO Resp. 43–44 (citing Ex. 2032, 87–90, 93; Ex. 2041 ¶¶ 91–95).” slip op. at 19

  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 · IPR2017-01374 · 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
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, IncSome claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01489 · APJ Zhenyu Yang · IPR · Final written decision

  The Board held claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 unpatentable as obvious; claims 65, 72, 75–77, and 79 were not …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “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. 7 (citing Pet. 16; 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. During trial, Patent Owner points out that Petitioner’s proposed definition “encompasses persons without advanced degrees but who have ‘knowledge gained through 4–5 years of work experience.’” PO Resp. 17. A person of ordinary skill in the art is a hypothetical person who is presumed to know the relevant prior art. Custom Accessories, Inc. v. Jeffrey–Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The artisan may gain such knowledge through either formal education or extensive work experience. Thus, we do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Having considered the complete record developed at trial, we see no reason to change our assessment.” slip op. at 9

  • 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. 9–10; Ex. 1501, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. See PO 17–18; Reply 5. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. In fact, Patent Owner does not appear to argue otherwise.7 Dr. Wilson, the expert witness for Patent 7 In a parallel proceeding involving the same patent, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to 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 ¶ 210 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1698, 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. 1699, 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. 1699, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1698, 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. 1699, 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”).” 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

    “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR, 550 U.S. at 421. Here, Queen 1989 recognizes the need to substitute framework residues in order to “reduce immunogenicity while retaining high binding affinity.” See Ex. 1534, 3. Thus, even if Queen 1990 is not available as prior art, we find that an ordinary artisan would have identified the candidates for substitution, as recited in claims 12, 42, 60, 71, 73, and 74. Indeed, Dr. Wilson testified that he performed a “good analysis” and identified 19 amino acid positions in the light chain and 19 in the heavy chain, including 66L (recited in claims 12 and 42), 73H (recited in claim 71), 78H (recited in claims 60 and 73), 93H (recited in claim 74). Ex. 1697, 242:4–6; Ex. 2041 ¶ 186, Appendix 1. Claims 12, 66, 67, 71, 73, 74, and 78” slip op. at 22

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 103 obviousnesscites 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.