• 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
• 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
• 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
• Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd. And Alkermes Controlled Therapeutics, Inc.Institution denied
  PTAB · Nov 30, 2016 · IPR2016-01095 · APJ Lora M Green · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–13 and 17–23 were unpatentable over Goldenheim alone or in the asserted combinations.

  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, 42.108. 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 claims 1‒13 and 17‒23. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2

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

    “[U]nless a reference discloses 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, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102. . . . [I]t is not enough that the prior art reference . . . includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008)). Here, as noted by Patent Owner, Petitioner is using disparate teachings of the Goldenheim reference to attempt to establish that the claims of the challenged patent are anticipated by that reference. The disclosure of Goldenheim of a viscosity of 35 cp in certain instances is a single sentence from that document, and Goldenheim provides no guidance as to what those circumstances may be. Petitioner has not sufficiently established that the ordinary artisan would have read that viscosity limitation into the formulation used by Example 16, which Petitioner relies upon to meet the concentration of microparticles required by challenged claim 1. In that regard, we note that Example 16 does not mention viscosity, and specifically teaches the use of an injection vehicle of 0.5% CMC and 0.1% Tween 80 in water. Ex. 1004, 52:27‒28” slip op. at 10

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

    “references remedy the deficiencies discussed above with respect to the anticipation rejection. As the Supreme Court pointed out in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” Id. at 418. Rather, the Court stated: [I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does . . . because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known. Id. at 418-419 (emphasis added); see also id. at 418 (requiring a determination of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue”) (emphasis added). In the instant proceeding, Petitioner has not provided a reason, however, as to why the ordinary artisan would have taken Goldenheim’s one mention of a viscosity of 35 cp and applied it to the formulation in Example 16 relied upon by Petitioner to meet the concentration limitation of independent challenged claim 1. Specifically, as noted by Patent Owner (Prelim. Resp. 20), Goldenheim teaches that “[i]n certain instances, the final reconstituted product viscosity may be, e.g., about 35 cps” (Ex. 1004, 35:11) but does not explain what those instances may be, much less tying that disclosure to the concentration of microparticles used in Example 16, which makes no mention of viscosity.” slip op. at 14

  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 6,667,061
• Hamilton Beach Brands, Inc. v. F’Real Foods, LLCInstitution denied
  PTAB · Nov 30, 2016 · IPR2016-01105 · APJ Brian P Murphy · IPR · Institution

  Institution was denied because Petitioner did not show a reasonable likelihood of proving claims 1 and 6–11 anticipated by Neilson or claims 1 and 5–11 obvious over the asserted combinations.

  RulingsInstitution decision

  • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

    “October 6, 2014—the date the 2014 Complaint alleging infringement of the ’658 patent was served on Petitioner. Prelim. Resp. 5, 11. It is undisputed, however, that Patent Owner did not own the ’658 patent at the time the 2014 Complaint was filed and served. Pet. 4; Prelim. Resp. 7; Ex. 1030 ¶¶ 5–7. Title to the ’658 patent was transferred to Patent Owner by an assignment executed January 25, 2016. Pet. 4; Prelim. Resp. 9; Ex. 1030 ¶ 7, Ex. C (patent assignment). Accordingly, Patent Owner lacked standing to sue for infringement of the ’658 patent at the time the 2014 Complaint was filed and served. Paradise Creations, Inc. v. UV Sales, Inc., 315 F.3d 1304, 1309 (Fed. Cir. 2003) (“[I]n order to assert standing for patent infringement, the plaintiff must demonstrate that it held enforceable title to the patent at the inception of the lawsuit.”). The patent counts of the 2014 Complaint were jurisdictionally defective, and the defect could not be cured after the filing date of the complaint, e.g., by a subsequent assignment or by joining the patent title holder to the lawsuit. Alps S., LLC v. Ohio Willow Wood Co., 787 F.3d 1379, 1385 (Fed. Cir. 2015), cert. denied, 136 S. Ct. 897 (2016) (“The party asserting patent infringement is ‘required to have legal title to the patents on the day it filed the complaint and that requirement can not be met retroactively.’”) (quoting Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359, 1366 (Fed. Cir. 2010)). The Delaware district court was required to—and actually did— dismiss the patent infringement counts of the 2014 Complaint for lack of Article III standing. Ex. 1031 n.1 (Delaware district court order granting motion for voluntary dismissal: “the court lacks jurisdiction to make a judgment on the merits”); see also, Abraxis, 625 F.3d at 1367 (“[T]he action must be dismissed because [plaintiff] lacked standing on the day it filed the action.”); Schreiber Foods, Inc. v. Beatrice Cheese, Inc., 402 F.3d 1198, 1203 (Fed. Cir. 2005) (“[I]f the original plaintiff lacked Article III initial standing, the suit must be dismissed, and the jurisdictional defect cannot be cured by the addition of a party with standing, . . . nor by the subsequent purchase of an interest in the patent in suit.”) (citing Paradise, 315 F.3d at 1309). Thus, the allegation of infringement of the ’658 patent in the 2014 Complaint was not a proper federal pleading and did not trigger the one-year time period under 35 U.S.C. § 315(b). Petitioner was not served with a complaint properly alleging infringement of the ’658 patent until January 2016. The instant petition was filed in May 2016. Accordingly, the Petition is not time-barred under § 315(b).” slip op. at 9

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

    “unpatentable under 35 U.S.C. § 102(b) and claims 1 and 5–11 as unpatentable under § 103. Pet. 9. Based on the arguments and evidence presented in the Petition and Preliminary Response, we determine Petitioner has not established a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Therefore, institution of an inter partes review is denied.” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Petitioner and Patent Owner offer competing constructions for several claim terms. Pet. 18–20; Prelim. Resp. 26–35. We determine that only the following claim terms require express construction for purposes of this Decision. See, e.g., 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.’”) (citation omitted).” slip op. at 13

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

    “position.” During a mixing operation, the ’658 patent describes how the cup holder is reciprocated to move axially upward so the mixing element is in a position within the liquid-filled cup, i.e. the recited “first position,” then reciprocated downward so the mixing element is moved upward to the recited “second position” closer to the opening at the top of the cup, “to allow the blade to pass through the full contents of the cup more than one time.” Ex. 1001, 3:58–64. When the mixing element is moved upward within the cup to the second position, the weight of the splash shield must be sufficient to keep the liquid-filled cup in the cup holder. Id. at 4:3–10 (“heavy enough to create sufficient downward force on the cup to overcome any upward force created by the mixing blade being moved upwardly in the cup”). The force generated by upward movement of the mixing element is not further described in the ’658 patent, although the ’658 patent provides a preferred embodiment where a splash shield weighing 5 pounds (dependent claim 5) provides sufficient downward force to perform the recited function. Id. at 4:20–23. Petitioner argues that “sufficient mass” in claim 1 should be construed in accordance with the interpretation allegedly offered by Patent Owner in the dismissed patent action: “the splash shield applies sufficient weight to the top of the cup to retain the cup in the cupholder during mixing.” Pet. 19 (no citation). Petitioner further argues that “the mass of the splash shield” limitation in claim 6 should be construed in accordance with the construction allegedly offered by Patent Owner in the dismissed patent action: “the splash shield applies sufficient weight to the top of the cup to prevent separation of the cup from the cupholder during mixing.” Id. (no citation). Patent Owner responds with a slightly different interpretation of a splash shield having a “sufficient mass”: “heavy enough to retain the vessel within the holder during relative movement of the mixing element and vessel.” Prelim. Resp. 31 (citing Ex. 1001, 4:3–24; Ex. 2025 (definition of “sufficient”)). Both parties appear to agree that the ’658 patent describes the “sufficient mass” of the splash shield in functional terms as enough weight to retain the vessel or cup within the holder during mixing. Ex. 1001, 3:65– 4:23. Based on the description provided in the ’658 patent, the claim language at issue in claim 1 – “the splash shield having sufficient mass to retain the vessel within the holder during relative movement of the mixing element and vessel from the first position to the second position when liquid is present in the vessel” – is entitled to its plain and ordinary meaning: “the splash shield is heavy enough to create sufficient downward force on the vessel so as to retain the vessel within the holder when the mixing element moves upwardly in the vessel from the first position to the second position when liquid is present.” See Ex. 1001, 4:3–10 (“heavy enough to create sufficient downward force on the cup to overcome any upward force created by the mixing blade being moved upwardly in the cup”). The claim language in claim 6 “the mass of the splash shield preventing separation of the holder and the vessel during translation” is similarly construed to mean “the splash shield is heavy enough to create sufficient downward force on the vessel so as to prevent separation of the holder and the vessel during translation of the mixing element or holder.”” slip op. at 14

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 7,520,658
• The Gillette Company v. Shavelogic, Inc.Institution denied
  PTAB · Sep 9, 2016 · IPR2016-00699 · APJ Richard H Marschall · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 1–6 were unpatentable under any of six obviousness grounds.

  RulingsInstitution decision

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

    “Patent Owner’s arguments are persuasive. As discussed above, the claimed “longitudinal axis of inertia” at a minimum requires a longitudinal axis that passes through the center of mass of the handle. Petitioner, using only its own proposed construction in its analysis of the prior art, ignores this requirement. Petitioner never alleges that the axis disclosed by Ohtsubo and passing through the “center line of the gripping section” of the handle in Ohtsubo also passes through the center of mass of the handle. Petitioner never mentions the center of mass in the analysis of Ohtsubo or any of the other prior art references. In addition, the Petition and accompanying Slocum Declaration fail to set forth sufficient evidence from which we could find that the prior art discloses angles with respect to a longitudinal axis passing through the center of mass of the handle. Similarly, Petitioner’s argument that the claimed angle would have been an obvious matter of design choice relies on Petitioner’s flawed construction, and fails to allege, much less establish, that arriving at the claimed angle using a longitudinal axis passing through the handle’s center of mass would have been an obvious matter of design choice. Pet. 23–24. Accordingly, we find that Petitioner has failed to establish that the combination of Jian and Ohtsubo discloses this limitation, or that the claimed angle would have been an obvious matter of design choice. Because Petitioner failed to establish a reasonable likelihood that claim 1 is unpatentable, and the remaining claims 2–6 at issue in Ground I depend from claim 1, we decline to institute on Ground I.” slip op. at 12

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

    “The parties seem to agree that Figure 7E is controlling, as both parties cite to the figure in support of their respective positions. Pet. 10; POPR 10. For purposes of this Decision, we agree. The description of Figure 7E confirms that it “is a diagram illustrating how the longitudinal axis of inertia of the handle is measured.” Ex. 1001, 3:61–62; see also id. at 6:22–24 (“These angles are measured between the longitudinal axis of inertia of the handle (see FIG. 7E) and the skin surface.”). Because the specification indicates that Figure 7E illustrates how to measure the longitudinal axis of inertia, and the remaining text of the specification does not define the term, we rely on Figure 7E to construe “longitudinal axis of inertia” in claim 1. Figure 7E depicts the longitudinal axis passing through the center of mass of the handle. Id. at Fig. 7E. The figure identifies the center of mass with a symbol and explains that the center of mass corresponds to that symbol in a legend. Id. Petitioner’s construction, with reference to an axis extending “generally through the center of the gripping portion of the handle,” may be consistent with Figure 7E in a broad sense, but Petitioner’s proposed construction does not go far enough. Figure 7E does not merely disclose the longitudinal axis of inertia extending “generally through the center of the gripping portion of the handle,” but instead relies on the center of mass of the handle as a frame of reference to define the claimed axis. Id. Petitioner improperly employs broad language not found in the figure, while ignoring important details such as the intersection of the longitudinal axis of inertia with the center of mass that is specifically called out in the figure. On this record and for purposes of this Decision, we conclude that the correct construction of “longitudinal axis of inertia,” in light of the specification and in particular Figure 7E, at a minimum requires a longitudinal axis that passes through the center of mass of the handle.” slip op. at 8

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

    “Patent Owner’s arguments are persuasive. As discussed above, the claimed “longitudinal axis of inertia” at a minimum requires a longitudinal axis that passes through the center of mass of the handle. Petitioner, using only its own proposed construction in its analysis of the prior art, ignores this requirement. Petitioner never alleges that the axis disclosed by Ohtsubo and passing through the “center line of the gripping section” of the handle in Ohtsubo also passes through the center of mass of the handle. Petitioner never mentions the center of mass in the analysis of Ohtsubo or any of the other prior art references. In addition, the Petition and accompanying Slocum Declaration fail to set forth sufficient evidence from which we could find that the prior art discloses angles with respect to a longitudinal axis passing through the center of mass of the handle. Similarly, Petitioner’s argument that the claimed angle would have been an obvious matter of design choice relies on Petitioner’s flawed construction, and fails to allege, much less establish, that arriving at the claimed angle using a longitudinal axis passing through the handle’s center of mass would have been an obvious matter of design choice. Pet. 23–24. Accordingly, we find that Petitioner has failed to establish that the combination of Jian and Ohtsubo discloses this limitation, or that the claimed angle would have been an obvious matter of design choice. Because Petitioner failed to establish a reasonable likelihood that claim 1 is unpatentable, and the remaining claims 2–6 at issue in Ground I depend from claim 1, we decline to institute on Ground I. Grounds II through VI rely on the same flawed arguments to establish that the combination of Jian and Ohtsubo discloses the claimed “planar rim surface being disposed at an angle of about 10 to 20 degrees with respect to a longitudinal axis of inertia of the handle.” Pet. 41–58. Patent Owner relies on additional references in these Grounds, but not in a manner that addresses the deficiencies noted above. Id. We therefore decline to institute on Grounds II through VI for the same reasons discussed above.” slip op. at 12

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,789,282
• Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratory, Inc. v. Helsinn Healthcare S.A.Institution denied
  PTAB · Aug 17, 2016 · PGR2016-00008 · APJ Toni R Scheiner · PGR · Institution

  The Board denied institution because Petitioner did not show that claims 1–19 lacked written-description support or violated the AIA on-sale bar.

  RulingsInstitution decision

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

    “35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard is set forth in § 324(a), which provides that a post-grant review shall not be instituted unless “the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, we determine that Petitioner has failed to demonstrate that it is more likely than” slip op. at 2

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “The written description requirement is satisfied when the specification “set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what 7 Patent Owner additionally provides Appendix A to the Preliminary Response. Appendix A purportedly maps the requirements of claims 1–19 to the specification. 11 is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004). Here, it is undisputed that the specification describes formulations comprising the same ingredients, in the same amounts, concentrations, and combinations required by the challenged claims. Given this disclosure, one of ordinary skill in the art could hardly fail to recognize a description of the claimed formulations in the specification, whether or not the claims recite that the formulations are stable.” slip op. at 11

  • Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)Not shown unpatentableNot shown unpatentable

    “A person shall be entitled to a patent unless—(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . . As an AIA first-inventor-to-file patent, the ’942 patent is subject to AIA § 102(a)(1). Thus, the dispositive issue in this case is whether § 102(a)(1) requires a public sale or offer for sale of the claimed invention to trigger the on-sale bar.” slip op. at 18

  § 102 anticipation§ 112 disclosure
  Patents in suitUS 9,173,942

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.