• Initiative For Medicines, Access & Knowledge (I-Mak), Inc. v. Gilead Pharmasset LLCInstitution denied
  PTAB · Jun 13, 2018 · IPR2018-00103 · APJ Lora M Green · IPR · Institution

  The Board denied institution for claims 1–19 because the Petition did not show a reasonable likelihood that any challenged claim was anticipated by Klecker or Sommadossi, or obvious over Sommadossi and Klecker.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of any of the challenged claims. Accordingly, we decline to institute an inter partes review for any challenged claim of the ’572 patent.” slip op. at 2

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

    “reasonable likelihood that claim 1 is anticipated by Klecker. To anticipate a reference must expressly or inherently disclose “within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (2008). Moreover, “anticipation is not proven by ‘multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.’” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1069 (Fed. Cir. 2017) (internal citation omitted). “[A] disclosed genus may anticipate a claimed species when the genus is so small that one of ordinary skill in the art would ‘at once envisage each member of this limited class.’” Wasica Fin. GmbH v. Continental Auto. Sys., Inc., 853 F.3d 1272, 1285 (Fed. Cir. 2017) (quoting AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1379 (Fed. Cir. 2014)). In this case, we agree with Patent Owner that Petitioner is improperly using claim 1 as a roadmap to cherry pick teachings of the Klecker reference to arrive at compounds encompassed by the genus of that claim. For example, we acknowledge that Klecker teaches that a fluorine may be placed below the ring at the 2' position of the sugar ring. Ex. 1005, 19:25‒26. Petitioner does not point us to any teaching of Klecker, however, that teaches a compound that has both a methyl group and a fluorine at the 2' position of the sugar ring, regardless of whether the fluorine is in the up position or the down position. That is, although the broad genus of compounds disclosed by Klecker encompasses such compounds, Petitioner does not point us to any teaching, other than the broad disclosure of the genus, wherein “W, X, Y, [and] Z” may be “H, hydroxy, halogen, alkyl (C1- C6), alkoxy (C1-C6)a label containing moiety or a label” (Ex. 1005, 15:3‒5), that would direct the ordinary artisan to choose X and W such that one of X and W is methyl and the other is fluorine, much less pointing to support of X as fluorine and W as methyl.” slip op. at 11

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Petitioner relies on the Declaration of Dr. Fortunak in asserting that because Klecker teaches the X position may be substituted with fluorine and teaches that W can be an alkyl (C1 – C6), the ordinary artisan would understand from “general knowledge and common sense that methyl is a preferred lower alkyl in that group.” Pet. 34 (citing Ex. 1002 ¶ 92). Dr. Fortunak, however, merely repeats the statement in the Petition without citing any evidentiary support. See Ex. 1002 ¶ 92; see also id. ¶¶ 93‒95 (discussing choosing other substituents in the structure of Klecker). Conclusory statements by an expert “that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). Furthermore, Petitioner’s conclusory statements (Pet. 34‒35) that because C is the first substituent identified for J, and H and OH are the first two substituents identified for Y and Z and, thus, the ordinary artisan would immediately envisage a compound where J is C, Y is H, and Z is OH, do not sufficiently persuade us that the ordinary artisan would immediately envisage their implementation to arrive at compounds that fall within the genus of claim 1.” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “To the extent that Petitioner (Pet. 51‒52) is invoking inherency in arguing that the express teaching of Sommadossi that R7 may be chloro, 6 Britton et al., U.S. Patent 5,420,266, issued May 30, 1995 (Ex. 1011). bromo and iodo, is also an express teaching that R7 may be fluoro, we disagree that the use of fluoro as the R7 group is inherent in the teachings of Sommadossi. “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999), quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). Even though the ordinary artisan may have understood that fluoro is also a halogen and may be substituted for chloro, bromo, or iodo, the fact remains that Sommadossi taught the use of, inter alia, chloro, bromo, or iodo at the R7 position, specifically, rather than a halogen element, generally. Ex. 1006, 13:24‒27. Petitioner’s argument (Pet. 52) that “Sommadossi taught that R6 could be ‘chloro, bromo, fluoro, [or] iodo,’” is actually counter to Petitioner’s assertions. That is, that statement demonstrates that Sommadossi knew that “fluoro” could be included in the list of halogens. Moreover, Sommadossi defined the term “halo” as “chloro, bromo, iodo, and fluoro.” Ex. 1006, 52:31. Thus, to avoid inadvertently excluding a halogen, Sommadossi could have used the term “halo” in listing the possible substituents for the R7 group, but chose not to do so. Accordingly, we determine that Petitioner has not sufficiently established that Sommadossi anticipates the compounds of claim 1. Because, as discussed above in our analysis of the anticipation ground over Klecker, all of the claims require the compound of that claim, or a particular compound that falls within the genus of claim 1, Petitioner has also not sufficiently demonstrated that any of the challenged claims are anticipated by Sommadossi. Accordingly, we decline to institute trial as to any of the challenged claims on the basis that the claim is anticipated by Sommadossi.” slip op. at 17

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 7,429,572
• Hamilton Beach Brands, Inc. v. F’Real Food, LLCRehearing denied
  PTAB · Apr 25, 2018 · IPR2017-00765 · APJ Lora M Green · IPR · Rehearing

  The Board denied Hamilton Beach’s rehearing request and maintained its denial of institution, citing follow-on petition concerns and its discretion under §§ 314(a) and 325(d).

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with those principles in mind.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner

    “The Board has discretion not to institute an inter partes review. 35 U.S.C. § 314(a); Harmonic Inc. v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“the PTO is permitted, but never compelled, to institute an IPR proceeding”); see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board may authorize the review to proceed on all or some of the challenged claims and on all or some of the grounds of unpatentability asserted for each claim.”). When exercising that discretion, the Board may take into account whether “the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d); see Conopco, Inc. v. The Proctor & Gamble Co., Case IPR2014-00628, slip op. 5– 10 (PTAB October 20, 2014) (Paper 21) (declining to institute because substantially the same arguments previously were presented to the Board). The issue of whether substantially the same arguments were raised previously in IPR2016-01105 arises in the present case. In addition, when determining whether to exercise our discretion not to institute a trial proceeding under 35 U.S.C. § 314(a), we seek to balance the equities between the parties, i.e., Petitioner’s desire to be heard against Patent Owner’s interest in avoiding harassment through repeated challenges. 5 Exhibit 1002 in IPR2016-01105. 6 U.S. Patent Publication No. 2002/0189460 A1, filed April 11, 2002, published December 19, 2002, to Brown et al. (“Brown”). Exhibit 1003 in IPR2016-01105. See H.R. Rep. No. 112-98, pt.1, at 48 (2011) (post-grant proceedings conducted under the AIA “are not to be used as tools for harassment or a means to prevent market entry through repeated litigation and administrative attacks on the validity of a patent. Doing so would frustrate the purpose of the section as providing quick and cost effective alternatives to litigation.”). In circumstances such as the present case, the Board considers the potential inequity of a petitioner filing serial attacks against the same claims of a patent, while benefiting from patent owner’s arguments and/or the Board’s decision in prior cases. See, e.g., Nautilus Hyosung Inc. v. Diebold, Inc., Case IPR2017-00426 slip op. at 12–16 (PTAB June 22, 2017) (Paper 17) (citing Xactware Sols., Inc. v. Eagle View Techs., Inc., Case IPR2017-00034, slip op. at 6–11 (PTAB April 13, 2017) (Paper 9); Baker Hughes Inc. v. LiquidPower Specialty Prods., Inc., Case IPR2016-01896, slip op. at 9–11 (PTAB March 31, 2017) (Paper 10); Duk San Neolux Co., Ltd. v. Idemitsu Kosan Co., Ltd., Case IPR2017-00197, slip op. at 4–11 (PTAB March 31, 2017) (Paper 10); NVIDIA Corp. v. Samsung Elec. Co., Case IPR2016-00134, slip op. at 8 (PTAB May 4, 2016) (Paper 9); Toyota Motor Corp. v. Cellport Sys., Inc., Case IPR2015- 01423, slip op. at 8 (PTAB Oct. 28, 2015) (Paper 7)); see also Conopco, Case IPR2014-00628, slip op. at 11–12. Therefore, we must balance the parties’ competing interests when determining whether to exercise our discretion and decline to institute. Id.” slip op. at 5

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDecided for patent owner

    “An important reason for denying institution in the instant proceeding was that Petitioner had the advantage of Patent Owner’s preliminary response in IPR2016-01105, as well as the claim construction and analysis set forth in the decision denying institution in that proceeding. That is, Petitioner had the benefit of that information in crafting the challenges set forth in the instant proceeding, and, thus, was able to address Patent Owner’s arguments made in its preliminary response in IPR2016-01105, as well as address the concerns of the Board set forth in the decision denying institution in IPR2016-01105. Consideration of these factors is consistent with the principles set forth in General Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357, 15−19 (PTAB Sept. 6, 2017) (Paper 19) (“General Plastics”) (designated precedential Oct. 18, 2017) (setting forth a non-exhaustive list of factors to be considered in determining whether to institute a follow-on petition, including whether the same petitioner previously filed a petition directed to the same claims of the same patent, and whether, at the time of filing of the second petition, the petitioner already received the patent owner’s preliminary response to the first petition or received the Board’s decision on whether to institute review in the first petition). We noted further that Sato “was published nearly 30 years ago,” and Karkos issued on December 26, 2000. Dec. 11. We determined that Petitioner had not established that those references were not available to Petitioner when it filed the petition in IPR2016-01105. Id. We declined to provide a second chance merely because Petitioner’s “highly experienced searchers” did not find those references before the filing of the petition in IPR2015-01105. Id. (citing Pet. 6). That determination was another factor that informed our decision to exercise our discretion and decline to institute inter partes review in the instant proceeding. See, e.g., General Plastics at 16 (noting that other factors to be considered in granting a follow-on petition are whether at the time of filing of the first petition petitioner knew of the prior art asserted in the second petition or should have known of it, and whether the petitioner provides adequate explanation for the time elapsed between the filings of multiple petitions directed to the same claims of the same patent). Finally, we noted that we were “troubled by the implications of Petitioner’s overarching premise – that it is cost-effective and appropriate to wait for a claim construction and institution decision by the Board, and then launch a follow-on patent challenge in reliance on additional references that challenge the same patent claims already addressed by the Board.” Dec. 13 (citing Pet. 7‒8). As noted in the Decision denying institution, however, “[s]uch tactics increase the costs to Patent Owner and impose unnecessary demands on the finite resources of the Board.” Id.; see, e.g., General Plastics at 16 (noting another factor to be considered is the finite resources of the Board).” slip op. at 7

  • Other 314aInstitution denied discretionary otherDecided for patent owner

    “The Board has discretion not to institute an inter partes review. 35 U.S.C. § 314(a); Harmonic Inc. v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“the PTO is permitted, but never compelled, to institute an IPR proceeding”); see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board may authorize the review to proceed on all or some of the challenged claims and on all or some of the grounds of unpatentability asserted for each claim.”). When exercising that discretion, the Board may take into account whether “the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d); see Conopco, Inc. v. The Proctor & Gamble Co., Case IPR2014-00628, slip op. 5– 10 (PTAB October 20, 2014) (Paper 21) (declining to institute because substantially the same arguments previously were presented to the Board). The issue of whether substantially the same arguments were raised previously in IPR2016-01105 arises in the present case. In addition, when determining whether to exercise our discretion not to institute a trial proceeding under 35 U.S.C. § 314(a), we seek to balance the equities between the parties, i.e., Petitioner’s desire to be heard against Patent Owner’s interest in avoiding harassment through repeated challenges. 5 Exhibit 1002 in IPR2016-01105. 6 U.S. Patent Publication No. 2002/0189460 A1, filed April 11, 2002, published December 19, 2002, to Brown et al. (“Brown”). Exhibit 1003 in IPR2016-01105. See H.R. Rep. No. 112-98, pt.1, at 48 (2011) (post-grant proceedings conducted under the AIA “are not to be used as tools for harassment or a means to prevent market entry through repeated litigation and administrative attacks on the validity of a patent. Doing so would frustrate the purpose of the section as providing quick and cost effective alternatives to litigation.”). In circumstances such as the present case, the Board considers the potential inequity of a petitioner filing serial attacks against the same claims of a patent, while benefiting from patent owner’s arguments and/or the Board’s decision in prior cases. See, e.g., Nautilus Hyosung Inc. v. Diebold, Inc., Case IPR2017-00426 slip op. at 12–16 (PTAB June 22, 2017) (Paper 17) (citing Xactware Sols., Inc. v. Eagle View Techs., Inc., Case IPR2017-00034, slip op. at 6–11 (PTAB April 13, 2017) (Paper 9); Baker Hughes Inc. v. LiquidPower Specialty Prods., Inc., Case IPR2016-01896, slip op. at 9–11 (PTAB March 31, 2017) (Paper 10); Duk San Neolux Co., Ltd. v. Idemitsu Kosan Co., Ltd., Case IPR2017-00197, slip op. at 4–11 (PTAB March 31, 2017) (Paper 10); NVIDIA Corp. v. Samsung Elec. Co., Case IPR2016-00134, slip op. at 8 (PTAB May 4, 2016) (Paper 9); Toyota Motor Corp. v. Cellport Sys., Inc., Case IPR2015- 01423, slip op. at 8 (PTAB Oct. 28, 2015) (Paper 7)); see also Conopco, Case IPR2014-00628, slip op. at 11–12. Therefore, we must balance the parties’ competing interests when determining whether to exercise our discretion and decline to institute. Id.” slip op. at 5

  Discretionary denial
  Patents in suitUS 7,520,658
• Teoxane S.A. v. Allergan, PLC Et Al.Institution denied
  PTAB · Mar 9, 2018 · IPR2017-02002 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of prevailing on any challenged claim.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Taking account of the information presented, we determine that the Petition fails to make out that threshold showing for review. Accordingly, we deny the Petition and decline to institute a trial.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “A. The Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art at the time of the invention would have had a B.S. or M.S. in biochemistry, polymer chemistry, medicinal chemistry, pharmaceutical chemistry, or a related field with “several years” of practical experience. Alternatively, according to Petitioner, the ordinary artisan would have had less practical experience but a Ph.D. in one of those fields, or an M.D. in dermatology, plastic surgery, or a specialty related to the clinical use of dermal fillers. Pet. 10 (citing Ex. 1041 ¶¶ 12–13). Patent Owner does not contest that argument in the Preliminary Response. For purposes of this decision, we accept Petitioner’s definition, which, on this record, is consistent with the level of skill reflected in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reveal the level of ordinary skill in the art).” slip op. at 8

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

    “Second, a term in a patent preamble is limiting when it “breathes life and meaning into the patent claims.” In re Wertheim, 541 F.2d 257, 269 (CCPA 1976). “Whether to treat a preamble as a limitation is a determination ‘resolved only on review of the entire” patent disclosure “to gain an understanding of what the inventors actually invented and intended to encompass by the claim.’” Catalina Mktg. Int’l. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Corning Glass Works v. Sumitomo Electric U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). Our review of the ’475 patent persuades us that the inventors “actually invented and intended to encompass by” claim 1 a stable composition as defined in the specification. Catalina Mktg. Int’l., 289 F.2d at 808. The inventors disclosed and claimed a “stable” composition containing both HA and lidocaine that overcame the “relative inferior stability properties” of prior art compositions. Ex. 1001, 2:6–32. In that regard, the specification repeatedly refers to the ability of the claimed compositions to remain stable after high-temperature sterilization procedures (such as autoclaving) or shelf-storage storage for prolonged lengths of time. See, e.g., id. at 2:42–49 (contrasting the “enhanced stability” of the claimed compositions “relative to conventional HA-based compositions including” “lidocaine” “when subjected to sterilization techniques such as autoclaving” or “when stored for long periods of time at ambient temperature”);” slip op. at 10

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

    “One final point pertaining to the “stable” limitation requires discussion. The specification makes clear that stability, in the context of the ’475 patent, relates to the “shelf life” of the composition “when stored for a lengthy period of time” prior to injection into a patient, for example, “for a period of time of at least 6 months to a year or more.” Id. at 6:51–53, 13:51; see id. at 2:26–27 (objective of invention is to provide “HA-based injectable compositions which incorporate lidocaine” that are not “prone to” degradation “when placed in storage for any significant amount of time”), 4:42–43, 5:33–38 (composition has “enhanced stability” “when stored at ambient temperature for an extended period of time”), 8:4–5 (the composition of the invention will “remain stable when stored for long periods of time at room temperature”). Accordingly, we determine that the preamble term “stable” (Ex. 1001, 16:40) “breathes life and meaning into” claim 1 and, therefore, is limiting. In re Wertheim, 541 F.2d at 269. We adopt for purposes of this decision the following definition of “stable,” which is advanced by Petitioner: soft tissue filler that is free of viable microorganisms as determined by a sterility test recognized by a regulatory authority, the filler can be sterilized by any method known in the art, and is resistant to degradation such that the composition maintains one or more of the following aspects: transparent appearance, pH, extrusion force and/or rheological characteristics, hyaluronic acid (HA) concentration, sterility, osmolarity, and lidocaine concentration, after being effectively sterilized by autoclaving and subsequently stored at a temperature of at least about 25° C for at least about two months. Pet. 11. That construction is not opposed by Patent Owner at this stage of the proceeding (Prelim. Resp. 3–4) and is substantially consistent with an express definition set forth in the specification. Ex. 1001, 5:17–20.” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,450,475
• Teoxane S.A. v. Allergan, PLC Et Al.Institution denied
  PTAB · Mar 9, 2018 · IPR2017-01906 · APJ Grace Karaffa Obermann · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood of prevailing on any challenged claim.

  RulingsInstitution decision

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

    “We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Taking account of the information presented, we determine that the Petition fails to make out that threshold showing for review. Accordingly, we deny the Petition and decline to institute a trial.” slip op. at 2

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

    “printed publication” that was “sufficiently accessible to the public interested in the art” before the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). The touchstone of public accessibility is whether an ordinary artisan “exercising reasonable diligence” would have been able to locate the document prior to the critical date. SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008). Petitioner availed itself of two opportunities to make out that showing, but has not done so adequately. See Pet. 4, 14; Reply 1–5. slip op. at 11

  • Strike new argumentNew argument disregardedDecided for patent owner

    “favored providing Petitioner an opportunity to respond to the evidence, presented in the Preliminary Response, which undercuts the Petition’s bare attorney argument that the Elevess Summary qualifies as a printed publication. Paper 11 (providing Petitioner an opportunity to file a Reply and Patent Owner to file a Sur- Reply on that issue). In the Reply, however, Petitioner abandons the evidence presented in the Petition, does not address the evidence presented in the Preliminary Response, and instead advances an entirely new theory of public accessibility. Reply 1–5 (citing Exs. 1067, 1068, 1069, and 1070). Petitioner’s Reply to the Preliminary Response is not the proper place to raise such information, which should have been presented in the Petition. Because the argument and evidence presented in the Reply exceeds the scope of a proper reply, we have discretion to exclude it. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the corresponding opposition or patent owner response.”).” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

    “in claim 1 requiring a composition “wherein the lidocaine is freely released in vivo” (after injection in a patient). Ex. 1001 19:31. On that point, we agree with Patent Owner that the Petition fails to address adequately how the presence of HI in Hunter’s composition would affect the free release of lidocaine from the HA gel in vivo. See Pet. 20–21; Prelim. Resp. 14–15 (pointing out that the Petition includes no showing that the lidocaine in Hunter’s composition “would necessarily be ‘freely released’ in vivo” where Hunter discloses “very different compositions” that include both “hyaluronic acid and an inhibitory compound” that “can inhibit the activity of hyaluronidase” (quoting Ex. 1004, 11)).” slip op. at 17

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,357,795
• CSL Behring GmbH / CSL Behring LLC v. Shire Viropharma Inc.Institution denied
  PTAB · Dec 7, 2017 · IPR2017-01512 · APJ Lora M Green · IPR · Institution

  Institution was denied for claims 1-18: Schranz was not shown to be prior art, and the Jiang ground was denied under §325(d) because the same art and arguments were previously presented.

  RulingsInstitution decision

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

    “may request to cancel . . . claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” Before considering the ground before us based on Schranz, we must address whether Petitioner has provided a sufficient threshold showing that Schranz constitutes prior art under 35 U.S.C. § 102—a legal question based on underlying factual determinations. Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568” slip op. at 6

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

    “As was the case in Dep’t of Justice, the use of a joint declaration “invites innumerable practical difficulties in cross-examining the witnesses, in assessing the reliability of the statements made, and in evaluating the weight to be accorded to the opinions expressed.” Dep’t of Justice 10. For example, Dr. Machnig and Mr. Waldhauser declare in “our recollection.” Ex. 1013-A ¶ 4. It is unclear how two different declarants can have the same “recollection.” In addition, the declarants state that “[h]andouts of the poster . . . [were] picked up by us.” Id. ¶ 5. It is unclear from the Joint Declaration, however, if both declarants were together when the hand-out was picked-up, or if each declarant picked up the handout at separate times. We, therefore, afford the Joint Declaration of Dr. Machnig and Mr. Waldhauser little weight. See Dep’t of Justice 11. As it is the primary evidence on which Petitioner relies to demonstrate that Schranz is prior art, we determine that Petitioner has not made a threshold showing that Schranz is prior art to the ’111 patent. As Petitioner has not sufficiently demonstrated that Schranz is prior art to the ’111 patent, we determine that the Petition does not demonstrate a reasonable likelihood that challenged claims 1‒18 are rendered obvious by the combination of Schranz (as evidenced by Cinryze Label and Bock), Gatlin, Pharming, and Levi.” slip op. at 9

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “In the instant proceeding, we agree with Patent Owner that Petitioner is essentially making the same arguments as to obviousness over Jiang that the Examiner already considered. The prosecution history demonstrates that the Examiner considered many of the same issues with respect to the Schranz Declaration as Petitioner is arguing here. Although the Examiner noted in allowing the claims that Applicant Shire had established the secondary consideration of long-felt need and failure of others, the Examiner also stated that the art did not suggest the claimed dosage. We determine, therefore, that the Examiner did address the Schranz Declaration, and the Examiner’s concerns are similar to those raised by Petitioner in the instant proceeding. That is, as the Examiner stated: The Examiner has considered the arguments found in Dr. Schranz’s declaration concerning difficulty in higher concentration formulation. However, Dr. Schranz’s declaration provides little more than an assertion that it is difficult to reach such a concentration formulation, as opposed to actual evidence establishing that this (1) was a recognized problem in the art and (2) was generally not achievable via other means. Ex. 1001-B, 3041. Thus, the Examiner did acknowledge the lack of supporting evidence in the Schranz Declaration demonstrating that it was difficult to reach the claimed concentration.” slip op. at 13

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “As was the case in Dep’t of Justice, the use of a joint declaration “invites innumerable practical difficulties in cross-examining the witnesses, in assessing the reliability of the statements made, and in evaluating the weight to be accorded to the opinions expressed.” Dep’t of Justice 10. For example, Dr. Machnig and Mr. Waldhauser declare in “our recollection.” Ex. 1013-A ¶ 4. It is unclear how two different declarants can have the same “recollection.” In addition, the declarants state that “[h]andouts of the poster . . . [were] picked up by us.” Id. ¶ 5. It is unclear from the Joint Declaration, however, if both declarants were together when the hand-out was picked-up, or if each declarant picked up the handout at separate times. We, therefore, afford the Joint Declaration of Dr. Machnig and Mr. Waldhauser little weight. See Dep’t of Justice 11. As it is the primary evidence on which Petitioner relies to demonstrate that Schranz is prior art, we determine that Petitioner has not made a threshold showing that Schranz is prior art to the ’111 patent. As Petitioner has not sufficiently demonstrated that Schranz is prior art to the ’111 patent, we determine that the Petition does not demonstrate a reasonable likelihood that challenged claims 1‒18 are rendered obvious by the combination of Schranz (as evidenced by Cinryze Label and Bock), Gatlin, Pharming, and Levi.” slip op. at 9

  § 102 anticipationDiscretionary denial
  Patents in suitUS 9,616,111
• L’Oréal USA, Inc. v. Liqwd, Inc.Institution denied
  PTAB · Jul 19, 2017 · PGR2017-00011 · APJ Christopher M Kaiser · PGR · Institution

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

  RulingsInstitution decision

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

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

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

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

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

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

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

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

  Claim construction§ 112 disclosure
  Patents in suitUS 9,498,419
• Lupin Ltd. / Lupin Pharmaceuticals Inc. v. Pozen Inc.Rehearing denied
  PTAB · May 24, 2017 · IPR2015-01774 · APJ Toni R Scheiner · IPR · Rehearing

  The Board denied rehearing, leaving its denial of institution on the §103 grounds for claims 1–6 and 13–15 unchanged because Petitioner showed no abuse of discretion.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. 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

    “determined that Petitioner had not established a reasonable likelihood that it would prevail in showing the unpatentability of challenged claims 1–6 and 13–15 of U.S. Patent 8,852,636 B2 (Ex. 1001, “the ’636 patent”) on any of the five grounds advanced in the Petition (Paper 4, “Pet.”). Paper 15 (“Decision” or “Dec.”). Subsequently, Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively “Petitioner”) filed a Request for Rehearing (Paper 16, “Reh’g Req.” or “Request”) asking us to reconsider our Decision denying an inter partes review on two of the grounds advanced in the Petition: (1) whether claims 1–6 and 13–15 are unpatentable under 35 U.S.C. § 103(a) over Chen1 and Gimet;2 and (2) whether claims 1–6 and 13–15 are unpatentable under 35 U.S.C. § 103(a) over Gimet, Chandramouli,3 and Phillips.4” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 3

  § 103 obviousness
  Patents in suitUS 8,852,636
• The Gillette Company v. Shavelogic, Inc.Rehearing denied
  PTAB · Mar 16, 2017 · IPR2016-00699 · APJ Richard H Marschall · IPR · Rehearing

  The Board denied Gillette’s rehearing request and left intact the denial of institution on claims 1–6 because the petition did not show that Ohtsubo disclosed the construed limitation.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “for Rehearing could have been made, but were not, in the Petition. Despite relying almost exclusively on Figure 7E for its construction, which shows the longitudinal axis of inertia passing through the center of mass of the handle, the Petition never addresses the center of mass or explains why the limitation should not be construed to require an axis passing through the center of mass. Pet. 10. Petitioner addresses the issue for the first time in the Request for Rehearing. We cannot misapprehend or overlook arguments never made in the Petition.” slip op. at 3

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

    “inertia,” a limitation found in claim 1, the only independent claim. In our Decision, we noted that Petitioner argued “longitudinal axis of inertia” did not have a defined meaning to one of ordinary skill in the art, and that Figure 7E of the ’282 patent discloses the longitudinal axis of inertia. Dec. 6. We agreed that Figure 7E discloses the limitation, and that the figure, for purposes of the Decision, was controlling on the meaning of the term given the absence of any textual description of the term in the specification and the parties’ reliance on Figure 7E. Id. at 8. We concluded that because Figure 7E discloses the longitudinal axis of inertia passing through the center of mass of the handle, and specifically labels the center of mass in the figure, that “at a minimum” the limitation “requires a longitudinal axis that passes through the center of mass of the handle.” Id. at 9. Based on that construction, we agreed with Shavelogic, Inc. (“Patent Owner”) that Petitioner failed to establish that the prior art discloses the limitation, and we denied institution. Id. at 11–13.” slip op. at 2

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

    “Our conclusion as to the claim construction did not purport to construe the entire phrase “longitudinal axis of inertia of the handle” and only concluded that, “at a minimum,” the phrase requires a longitudinal axis that passes through the center of mass of the handle. Dec. 9. We did not suggest that the center of mass alone defined the axis, or further define the scope of “longitudinal axis of inertia.” Our limited construction was sufficient to address the issues raised by the Petition because Petitioner did not adequately establish that the prior art disclosed the limitation, so construed. Ohtsubo” slip op. at 6

  Claim construction§ 103 obviousness
  Patents in suitUS 8,789,282
• Fustibal LLC v. Bayer Healthcare LLCInstitution denied
  PTAB · Feb 8, 2017 · IPR2016-01490 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because Riedl was repeatedly considered during prosecution and the petition did not show a reasonable likelihood that claims 1–16 were unpatentable.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “§ 314(a); 37 C.F.R. § 42.108. Our discretion on whether to institute is guided, in part, by 35 U.S.C. § 325(d), which states that “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Patent Owner requests that the Board exercise its discretion to deny institution with respect to Ground 1 because Riedl was expressly considered by the Examiner during the prosecution of the ’553 Patent. Prelim. Resp. 7–8. As noted in section I(E), above, in allowing claims 1–16 of the ’533 Patent, the Examiner expressly referred to Riedl as the closest prior art, yet found that it “fails to teach . . . the instant claimed compounds.” Ex. 2006, 913; see also Ex. 2005, 397, 569; Ex. 2006, 855 (same, with respect to similar claims).” slip op. at 11

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

    “As an initial matter, the above argument fails because, as discussed in section I(C)(iii), above, Riedl does not “expressly disclose[] the rografenib compound,” as Petitioner contends. We further agree with Patent Owner’s observation “that the Petition nowhere engages in a ‘lead compound’ analysis” and, at least with respect to Ground 2, “merely assumes—without explanation—that the POSA would select sorafenib for modification.” Prelim. Resp. 22–23. A lead compound comprises “a natural choice for further development efforts” (Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1008 10 Petitioner provides similar arguments with respect to claims 1–12, 14, and 16. Id. at 22–25. (Fed. Cir. 2009)), i.e., a prior art compound “that would be most promising to modify in order to improve upon its . . . activity and obtain a compound with better activity” (Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). “In determining whether a chemist would have selected a prior art compound as a lead, the analysis is guided by evidence of the compound’s pertinent properties.” Otsuka Pharm., 678 F.3d at 1292. “Absent a reason or motivation based on such prior art evidence, mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection.” Id. In setting forth Ground 2, Petitioner invokes a person of ordinary skill in the art “who was looking to modify sorafenib.” Prelim. Resp. 22. Neither Petitioner nor Petitioner’s expert address why a skilled artisan reading Riedl would select that compound for further development. Given that Riedl does not highlight any of the vast number of disclosed compounds as having particularly beneficial properties or present any enzymatic or biological data, we also do not discern from this reference why a person of ordinary skill in the art would have selected sorafenib as “a natural choice for further development efforts.”” slip op. at 17

  • Skill levelSkill level petitioner adoptedOther

    “Person of Ordinary Skill in the Art. Petitioner contends that a person of ordinary skill in the art “typically would have a PhD, MD, MS, or another degree relating to pharmaceutical chemistry (e.g. biology, chemistry, medicinal chemistry, medicine, pharmacology, or a closely related discipline), and . . . would have substantial familiarity, training, or experience with pharmaceutical compositions.” Pet. 6. Patent Owner has not challenged Petitioner’s proposed interpretation of a skilled artisan. We adopt Petitioner’s proposed interpretation for purposes of this opinion. See Prelim. Resp. 6 & n.1; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evident from the prior art). B.” slip op. at 6

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

    “Petitioner (correctly) contends that the ’553 Patent expressly defines the claim term “pharmaceutically acceptable salt” as “‘a relatively non-toxic, inorganic or organic acid addition salt of a compound of the present invention.’” Pet. 7 (quoting Ex. 1001, 9:56–62). Patent Owner does not presently object to this definition. Based on the specification’s express disclosure, we agree that the cited definition applies. See Prelim. Resp. 6 & n.2. The parties agree that all other terms should be accorded their ordinary and customary meaning. Id.; Pet. 6–7. Our reviewing court counsels that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Accordingly, for purposes of this decision, we determine that no further construction is necessary. C.” slip op. at 7

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 8,637,553
• Swiss Pharma International AG v. Biogen IdecRehearing denied
  PTAB · Feb 3, 2017 · IPR2016-00912 · APJ Lora M Green · IPR · Rehearing

  The Board denied Swiss Pharma’s rehearing request, leaving institution denied for claims 1–16, 21, and 22 because the petition did not show a reasonable likelihood of obviousness.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2

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

    “however, that the variable to be optimized had to be recognized as a result effective variable. Id. at 620. In the instant case, Petitioner only suggests changing the concentration of the antibody to allow it to be stored in known vials. Petitioner does not explain, however, how merely adding a sufficient concentration of natalizumab to a known vial is a result effective variable. As noted by Patent Owner (Prelim. Resp. 40), Dr. Brod testified that “the concentration of natalizumab is not important from the stand-point of administration as partial, single or multiple vials can be added to an intravenous bag in order to provide the proper dose.” Ex. 1011 ¶ 27. Thus, although the testimony may be read as demonstrating that the concentration is not critical, it also demonstrates that the concentration of the antibody in terms of its storage was not recognized as a result effective variable.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “however, that the variable to be optimized had to be recognized as a result effective variable. Id. at 620. In the instant case, Petitioner only suggests changing the concentration of the antibody to allow it to be stored in known vials. Petitioner does not explain, however, how merely adding a sufficient concentration of natalizumab to a known vial is a result effective variable. As noted by Patent Owner (Prelim. Resp. 40), Dr. Brod testified that “the concentration of natalizumab is not important from the stand-point of administration as partial, single or multiple vials can be added to an intravenous bag in order to provide the proper dose.” Ex. 1011 ¶ 27. Thus, although the testimony may be read as demonstrating that the concentration is not critical, it also demonstrates that the concentration of the antibody in terms of its storage was not recognized as a result effective variable.” slip op. at 8

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We disagree. We noted in our decision that similarly to Soberra, Gordon also taught a 3 mg/ml infusion, and used a 5 mg/ml formulation. Dec. 12‒13. We then looked at the references relied upon by Dr. Schöneich in establishing that formulations were available in stoppered vials in a number of different volumes. Id. at 13. We noted that only one antibody solution was referenced by Dr. Schöneich, and that antibody solution contained 5 mg/ml of antibody. Id. The other references were directed to small molecule drugs, and we noted that Dr. Schöneich did not explain why the ordinary artisan would look to those references when formulating an antibody solution. Id. The fact that Petitioner may not agree with our consideration of the evidence does not mean that we overlooked that evidence, or that we misapprehended it.” slip op. at 11

  § 103 obviousness
  Patents in suitUS 8,815,236

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.