• 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
• Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.No claims unpatentable
  PTAB · Dec 28, 2018 · IPR2017-00435 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–4, 6–18, and 20 were not shown unpatentable over Malecki; the contingent motion to amend was denied as moot.

  RulingsFinal written decision

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

    “construction more persuasive because it is grounded in, and most consistent with, the specification of the ’731 patent. Contrastingly, Petitioner does not offer a specific interpretation of “inner walls” and its arguments are generally based on extrinsic evidence, including claim charts from the related district court litigation (Pet. 15), arguments from related proceedings (Pet. Reply 3), and the prior art reference (Malecki) relied on to challenge the claims (id. at 3–4). Petitioner criticizes the Patent Owner’s position but provides no express interpretation of “inner walls of the first and second clip arms;” instead, Petitioner argues why Patent Owner’s proposed construction is wrong. Pet. Reply 4–5. Dr. Nicosia does not expressly define or otherwise persuasively explain the definition of “inner walls” in his declarations either. See generally Exs. 1037, 1095, and 1109.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the time of the filing of the application that became the ’731 patent would have possessed the knowledge and skill of an engineer or similar professional 5 The parties have not introduced evidence of secondary considerations in this proceeding. with at least an undergraduate degree in engineering, or a physician having experience with designing medical devices. Pet. 10 (citing Ex. 1037 ¶ 11). Patent Owner does not dispute Petitioner’s proposal, and we adopt it based on the final record before us. It is also consistent with the level of skill evidenced by the references.” slip op. at 15

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id.” slip op. at 25

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

    “Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id. Finally, Petitioner seems to recognize that a modification would be” slip op. at 25

  Patent outcomesUS 9,271,731 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,271,731
• 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
• Donghee America, Inc. / Donghee Alabama, LLC v. Plastic Omnium Advanced Innovation And ResearchAll claims unpatentable
  PTAB · Dec 11, 2018 · IPR2017-01605 · APJ Christopher M Kaiser · IPR · Final written decision

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

  RulingsFinal written decision

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

    “article whose surface has at least one empty or concave part.” Id. at 11 (citing Ex. 1001, 1:66–67; Ex. 1007 ¶ 15). Patent Owner agrees. PO Resp. 15. The ’253 patent states that “[t]he term ‘hollow body’ is understood to mean any article whose surface has at least one empty or concave part.” Ex. 1001, 1:66–67. Where an inventor defines specific terms used to describe an invention, we will give effect to those definitions, as long as they are set out “with reasonable clarity, deliberateness, and precision,” “so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Here, the phrase “is understood to mean,” as used in the ’253 patent, signals that the inventor presents a clear, deliberate, and precise definition. Accordingly, we interpret “hollow body” as having the definition given it in the ’253 patent, “any article whose surface has at least one empty or concave part.”” slip op. at 6

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

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

  • Expert testimonyPatent owner expert discountedDecided for petitioner

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

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

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

  Patent outcomesUS 7,166,253 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 7,166,253
• 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
• 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

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.