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  • PTAB · Jan 8, 2018 · IPR2016-01434 · APJ Michael W Kim · IPR · Final written decision

    Claims 11–13 and 15–20 are unpatentable as obvious; claim 14 was not shown unpatentable because the cited personal notes were not “content contributed.”

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “While the parties use slightly different language, we are unable to discern any substantive differences between the proffered levels of skill and basic qualifications of a person of ordinary skill in the art. Accordingly, we adopt Dr. Papakonstantinou’s articulation of the level of ordinary skill as our own, if for no other reason then for its conciseness, with the understanding that the differences between the proffered levels of ordinary skill are limited and inconsequential in our analysis.” slip op. at 23

    • Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for patent owner

      “above-identified single statement in the specification, which uses permissible language such as “can be” and “does not need to be,” is sufficient to justify Patent Owner’s assertions, which for all practical purposes, is a disavowal of claim scope. See Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004) (“Absent a clear disavowal in the specification or the prosecution history, the patentee is entitled to the full scope of its claim language.”) We also credit the testimony of Dr. Almeroth over that of Dr. Papakonstantinou, because, among other reasons, Dr. Almeroth supports his testimony with relevant citations to the specification, while Dr. Papakonstantinou largely repeats that which is set forth in the Patent Owner Response, without further analysis. graphical fields that allow the input of administrative information without programming” are advantageous over “cumbersome programming performed in the past.” Ex. 2002 ¶¶ 44, 47. We treat this argument as subsumed within Patent Owner’s argument that the specification disparages prior art systems that require HTML programming to perform administrative tasks.” slip op. at 16

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

      “224, 232 encompasses a “link to content.” In application, however, “what is a wireless LAN?” 224, 232 is actually two separate components: (1) the underlying technical set of computer instructions that, upon clicking the link associated with “what is a wireless LAN?” 232, transports a user to a web page associated with “what is a wireless LAN?” 232; and (2) the words “what is a wireless LAN?” 224 itself displayed on the computer display, but separate from the technical set of computer instructions set forth in (1). In this example, (1) is “link to content, but not itself ‘content,’” however, (2) is itself “content.” More precisely, when we now consider “what is a wireless LAN?” 224, 232 in relation to the aforementioned construction of “content” as “electronic data embodying information for an individual or individuals,” it becomes clear that “what is a wireless LAN?” 224, 232 is both “links to content” and “content.” Specifically, component (1) of “what is a wireless LAN?” 232 is “links to content,” but not “content” itself, because the underlying technical set of computer instructions is not “electronic data embodying information for an individual or individuals,” but for a computer. By contrast, component (2) of “what is a wireless LAN?” 224 is “content,” as it is clearly “electronic data embodying information for an individual or individuals,” in that the words “what is a wireless LAN?” are intended to convey information to an individual. So, as a practical matter, we discern that every disclosure of a “link to content” that includes “electronic data embodying information for an individual or individuals” (i.e., any information associated with a “link” that is separate from a generic indication of the “link” itself), is “content.” See also Ex. 3001, 6–16 (providing further analysis concerning construction, which we expressly incorporate herein). Accordingly, we determine that a proper construction of “content” is “electronic data embodying information for an individual or individuals,” and excluding “links to content,” but not excluding “content” associated with the “links to content.”” slip op. at 10

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed petitioner constructionDecided for petitioner

      “We agree with Petitioner. We are persuaded that “administrative interface” is broader than the “administrative page” mentioned in the specification, in that an “administrative interface” may encompass 9 While discussing “graphical user interface” during oral argument, Patent Owner stated that it was not disclaiming claim scope. Tr. 47:20–22 (“We’re not arguing that the claim terms have been disclaimed in some phrase.”). something other than an “administrative page.” We are also persuaded that the specification’s disclosure of a non-limiting embodiment, that of a highlyautomated and browser-based “administrative page,” does not require that a proper construction of “administrative interface” include “graphical user interface.” As admitted by Patent Owner, these pages are “example[s]” only, and, at best, merely “impl[y]” the presence of a “graphical user interface.” See PO Resp. 8–9 (citing Ex. 1002, 16:39–44; Ex. 2002 ¶ 40). We are persuaded that an “implied example” does not belong in a proper construction of a claim term. Indeed, Petitioner asserts that Patent Owner’s factual premise, concerning the above “implied example,” is flawed, as the specification’s “reference to automation and a browser provides no basis for restricting the claimed ‘administrative interface’ to a graphical user interface.” Pet. Reply 5–6 (citing Ex. 1033 ¶ 15) (Dr. Almeroth testifies that “automation of computer systems does not require a graphical user interface.”). More specifically, Dr. Almeroth identifies other automated “interfaces” in the specification, such as “a networked cash register, bar code scanner or electronic product code reader” (Ex. 1002, 13:8–15, 14:51–52) that do not require a “graphical user interface.” Ex. 1033 ¶ 14. We agree with Dr. Almeroth’s analysis of the specification. Dr. Almeroth asserts further, and we agree, again, that “[o]ne of ordinary skill would understand that that cash register could be connected to a server that is accessible only via a command line interface, and that administrators could use command-line tools . . . to group content on that server.” Ex. 1033 ¶ 14. Patent Owner cites In re Abbott Diabetes Care, Inc., 696 F.3d 1142, 1149–1150 (Fed. Cir. 2012) for its finding of an implicit definition of a” slip op. at 13

    Patent outcomesUS 7,516,177 mixed
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 7,516,177
  • PTAB · Oct 9, 2015 · IPR2015-00802 · APJ Susan L C Mitchell · IPR · Institution

    The Board denied institution on claims 1–4, finding no reasonable likelihood of success because Plachetka was not prior art and the obviousness showing was deficient.

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

      “We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . 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). Upon considering the Petition and Preliminary Response, we conclude that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of any challenged claim of the ’285 patent. Therefore, we do not authorize an inter partes review for any claim of the ’285 patent.” slip op. at 2

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

      “For the reasons set forth above, Petitioner fails to convince us that the claims of the ’285 patent are not supported by at least the ’216 application. Therefore, the Plachetka Publication does not qualify as prior art under 35 U.S.C. § 102(b). Consequently, Petitioner has failed to establish a reasonable likelihood that it would prevail in showing that claims 1–4 are unpatentable as anticipated by the Plachetka Publication.” slip op. at 19

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away foundMotivation not foundDecided for patent owner

      “An enteric-coated dosage form of omeprazole must be perfectly coated and acid resistant, since, if any drug leaks out of the dosage form in the stomach, it is almost immediately degraded. The same is the case if an acidic medium can diffuse into the dosage form through pin-holes or damage in the enteric-coating. We agree with the Patent Owner that Pilbrant teaches away from the claimed combination. Prelim. Resp. 36 (“Petitioner’s failure to acknowledge the complete disclosure of Pilbrant, which negates any motivation to use the non-enterically coated form of esomeprazole, despite the testimony of Petitioner’s own expert, is an incurable flaw in the Petition”). When a prior art reference teaches away from combining known elements, discovery of a successful means of combining them is more likely to be nonobvious. See KSR Internat’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). A reference teaches away “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994), cited in In re Mouttet, 686 F.3d 1322, 1333-34 (Fed. Cir. 2012). We disagree with Petitioner’s conclusion that although one of skill in the art “might have believed” that enteric coated esomeprazole was generally the better option, “that does not exclude the use of non-enteric coated esomeprazole as still ‘good enough’ to be obvious, at least in a combination product where all the esomeprazole needs to do is raise the stomach pH to 3.5.” Pet. 51. Here, the very statement that Petitioner relies upon from Pilbrant to support its rationale to combine concerning preabsorption degradation of omeprazole caused Pilbrant to rule out the use of conventional oral dosage forms without an enteric coating. We agree with the Patent Owner that Petitioner’s “[m]otivation to combine in the face of an express teaching away must be found in the prior art itself and reliance on the teachings of the ’285 patent is impermissible hindsight.” Prelim. Resp. 37.” slip op. at 25

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

      “Both parties acknowledge that the claim requires a therapeutically effective amount of naproxen must be surrounded by a coating. Pet. 27; Prelim. Resp. 7. Petitioner’s interpretation, however, turns this requirement on its head. As Patent Owner notes, using the transitional term “comprising” means that additional components may be present, but does not change the elements that are stated in the claim. Prelim. Resp. 8 (citing Outside the Box Innovations, LLC v. Travel Caddy, Inc., 695 F.3d 1285, 1305 (Fed. Cir. 2012)). Petitioner’s interpretation, however, would encompass a composition where the vast majority of the naproxen, i.e., a therapeutically effective amount, would be outside of the coating. This is not a reasonable interpretation of the claim. We agree with Patent Owner that the broadest reasonable interpretation of the term “comprising . . . naproxen surrounded by a coating” means “a therapeutically effective amount of naproxen is surrounded by a coating,” but do not agree with Patent Owner’s arguments that this claim term excludes any uncoated naproxen from the claim. As Petitioner notes, the Patent Owner has previously addressed the meaning of this limitation in response to invalidity contentions asserting lack of written description support and enablement, stating that the specification of the ’285 patent supports the interpretation “that, in addition to naproxen surrounded by a coating that inhibits its release unless the surrounding medium of the unit dosage form is at least 3.5, the disclosed dosage forms may include additional naproxen outside the coating.” Ex. 1010, 49 (Patent Owner’s responses to invalidity contentions for the ’285 patent) (relying on statements in the specification of the ’285 patent where the combination of an acid inhibitor and an NSAID may be in multi-layer tablet form and where the drug combinations may typically be prepared in admixture with conventional excipients). Patent Owner also has previously stated that the transitional term “comprising” does not exclude the presence of additional naproxen outside of the coating. Id. at 51. We agree. Although the claim term requires that a therapeutically effective amount of naproxen in a unit dosage form is surrounded by a coating, it does not exclude a unit dosage form that has an amount of naproxen outside of the coating that is not therapeutically effective. Therefore, we do not agree that the claims of the ’285 patent” slip op. at 12

    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,557,285
  • PTAB · Sep 24, 2015 · IPR2014-00784 · APJ Christopher M Kaiser · IPR · Final written decision

    Claims 1–32 are unpatentable as obvious over Chiba and Aulton; the motion to amend with proposed claims 33–64 is denied.

    RulingsFinal written decision
    • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

      “institute an inter partes review of claims 1–32 of U.S. Patent No. 8,324,283 B2 (“the ’283 patent,” Ex. 1001). Paper 2 (“Pet.”).1 On December 1, 2014, the Board instituted trial to review patentability of the challenged claims. Paper 11 (“Dec. on Inst.”). Apotex, Inc. and Mylan Pharmaceuticals Inc. (“Apotex,” or, together with Torrent, “Petitioners”) filed a separate Petition also seeking to institute an inter partes review of claims 1–32 of the ’283 patent. IPR2015-00518, Paper 1 (“IPR-518 Pet.”). This second Petition was accompanied by a motion seeking joinder with the trial that had been instituted in IPR2014-00784. IPR2015-00518, Paper 2 (“IPR-518 Joinder Mot.”). On February 17, 2015, the Board instituted trial in IPR2015-00518 and joined the proceedings in IPR2014-00784 and IPR2015-00518. IPR2015-00518, Paper 8 (“IPR-518 Dec.”).” slip op. at 2

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

      “unexpired patent according to its broadest reasonable construction in light of the specification of the patent in which it appears. 37 C.F.R. § 42.100(b); see In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1276–79 (Fed. Cir. 2015). Under that standard, absent any special definitions, we assign claim terms their ordinary and customary meaning, as understood by a person of ordinary skill in the art, in the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). For this reason, we do not construe several terms for which constructions were proposed in the Petition but about which the parties do not disagree.” slip op. at 6

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

      “Where the prior art teaches the claimed invention, a claim is not rendered patentable by virtue of being motivated in the inventors’ minds by a newly-discovered advantage of the prior-art combination; allowing such a claim to stand “would remove from the public that which is in the public domain.” In re Wiseman, 596 F.2d 1019, 1022 (CCPA 1979); see also Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”). Here, Patent Owners argue that the newly discovered low-dose instability of fingolimod when mixed with common excipients motivated the inventors’ choice of the allegedly less common mannitol as an excipient. PO Resp. 12–15 (citing Ex. 2043 ¶¶ 14–19, 22, 24–36). As explained above, though, it does not matter that the prior art failed to recognize this advantage of a fingolimod-mannitol combination. “[T]he motivation in the prior art to combine the references does not have to be identical to that of the [patentee] to establish obviousness.” In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996).” slip op. at 14

    Patent outcomesUS 8,324,283 unpatentable
    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 8,324,283
  • PTAB · Sep 24, 2015 · IPR2015-00518 · APJ Christopher M Kaiser · IPR · Final written decision

    Claims 1–32 are unpatentable as obvious over Chiba and Aulton; Patent Owners’ motion to amend with claims 33–64 is denied.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

      “discovered a new advantage of a combination of prior-art ingredients is not sufficient to render the claims of the ’283 patent patentable, as long as there was some reason to combine the prior-art teachings that those ingredients should be used. Patent Owners argue that Petitioners have failed to prove such a reason to combine, PO Resp. 41–49, but the record establishes otherwise. First, Chiba teaches that a person of ordinary skill in the art would have been able to identify or easily determine excipients that would have been compatible with fingolimod. Ex. 1006, 11:24–28 (“pharmaceutically or physiologically acceptable carriers or excipients for use with the . . . compounds noted herein are known in the art or can be readily found by methods and tests known in the art”). Second, Aulton teaches that mannitol is not only a known diluent for direct compression manufacturing, but also commonly used in wet granulation, which Aulton teaches is “the most widely used method for pharmaceutical materials.”12 Ex. 1021, 39–41, Table 18.1. This combination of teachings already strongly suggests that mannitol likely would have been a target of investigation for a person of ordinary skill in the art interested in finding an excipient compatible with fingolimod, but there is additional evidence of the reason to combine fingolimod and mannitol.” slip op. at 15

    • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner

      “and mannitol shows unexpected results. “It is the established rule that ‘objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support.’” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 965 (Fed. Cir. 2014) (quoting In re Tiffin, 448 F.2d 791, 792 (CCPA 1971)). This is as true for evidence of unexpected results as it is for any other type of objective evidence of non-obviousness. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“the applicant’s showing of unexpected results must be commensurate in scope with the claimed range”); In re Clemens, 622 F.2d 1029, 1035 (CCPA 1980) (“In order to establish unexpected results for a claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support.”). The evidence of unexpected results made of record is not commensurate in scope with claim 19. First, according to Patent Owners, the claimed combination was stable at low doses of fingolimod, even though combinations of fingolimod and other excipients were unstable at those same low doses. PO Resp. 54; see also id. at 11–15 (citing Ex. 2042 ¶¶ 39–40; Ex. 2043 ¶¶ 14–19, 22, 24–36) (describing difference in results between low-dose fingolimod-mannitol mixtures and mixtures of low doses of fingolimod with other excipients). But, as Petitioners note, Reply 3–4 (citing Ex. 1031 ¶ 85; Ex. 2271, 50:21– 51:919), claim 19 is not limited to any particular dose or dose range of fingolimod. Instead, claim 19 recites only a solid oral dosage form containing mannitol and either fingolimod or a pharmaceutically acceptable salt of fingolimod. Ex. 1001, 18:7–10. Thus, even if the stability of the mannitol-fingolimod combination at low doses was unexpected, it is insufficient to support a legally significant finding of unexpected results. Second, Patent Owners argue that the stability achieved with mannitol “is superior to other choices [of excipient] to a surprising extent,” given that “mannitol preserves 4.5 to 11 times as much fingolimod as lactose, microcrystalline cellulose, and starch.” PO Resp. 54 (citing Ex. 2007 ¶¶ 12– 13). This evidence of unexpected results suffers from the same flaw discussed above. See Reply 17 (citing Ex. 1031 ¶ 85). Not only is this evidence limited to low doses of fingolimod, it is limited to a single, specified dose, 0.25 mg. Ex. 2007, 5 (stating that testing was performed using 25 µL of a 10 mg/mL drug substance solution). As such, it is evidence of unexpected results only across a tiny portion of the unlimited dose range 19 A public version is available at Ex. 2276, 50:21–51:9. of claim 19, which is insufficient to support a finding of unexpected results.20” slip op. at 21

    • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersObjective indicia no nexusDecided for petitioner

      “We find Petitioners’ argument persuasive. If objective indicia of nonobviousness are “due to an element in the prior art, no nexus exists.” Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 (Fed. Cir. 2011) (discussing commercial success). Here, the evidence of long-felt need shows that there was a need merely for a solid oral multiple sclerosis medication, not specifically for a medication of the form recited in claim 19. But the general need for a solid oral multiple sclerosis medication was 21 Patent Owners are reminded that 37 C.F.R. § 42.23(a) requires a Response to “comply with the content requirements for motions,” and 37 C.F.R. § 42.22(a)(2) requires motions to include “a detailed explanation of the significance of the evidence.” satisfied in the prior art. In 1999, Chiba itself suggested treating multiple sclerosis using a solid oral form of fingolimod. Ex. 1006, 6:26–49, 8:19–26. In addition, teriflunomide, marketed in solid tablet form as Aubagio®, was known in the prior art at least by April 1, 2002, when it was disclosed to be useful for treating multiple sclerosis when administered in tablets or capsules. Ex. 1037, at [22], 1:19–30, 2:60–3:2, 5:1–21; Ex. 2045 ¶ 63.22 Similarly, a capsule form of dimethyl fumarate for the treatment of multiple sclerosis, marketed as Tecfidera™, Ex. 1070, 2, was disclosed in U.S. Patent No. 6,509,376 B1, issued January 21, 2003. Ex. 1097, at [45], 2:64–67, 4:25–27, 4:31–33. Because the prior art contained solid oral multiple sclerosis treatments using active ingredients other than fingolimod, the fingolimod claimed in claim 19 was not necessary to satisfy any long-felt need for a solid oral multiple sclerosis treatment. Nor was the mannitol recited in claim 19: the evidence of record shows that sugar alcohols were not necessary to make even fingolimod suitable for oral administration. Ex. 2271, 250:10– 251:15.23 Accordingly, claim 19 did not solve any need for a solid oral multiple sclerosis treatment that was not already solved in the prior art.” slip op. at 24

    • Obviousness (§103) › Objective indicia / secondary considerations › Skepticism / industry praiseObjective indicia no nexusDecided for petitioner

      “Industry praise must be linked to the patented invention. Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1352 (Fed. Cir. 2010). Again, if objective indicia of nonobviousness are “due to an element in the prior art, no nexus exists.” Tokai Corp., 632 F.3d at 1369. Here, the evidence shows that what was praised about Gilenya was not the specific formulation recited in claim 19, but rather the general fact that Gilenya was a solid oral multiple sclerosis medication. As discussed above, however, a solid oral multiple sclerosis formulation was known in the prior art, so there is no nexus between the claimed invention and the industry praise.” slip op. at 26

    Patent outcomesUS 8,324,283 unpatentable
    § 103 obviousnesscites Phillips
    Patents in suitUS 8,324,283
Page 5 of 5

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.