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  • PTAB · Nov 28, 2018 · IPR2017-01358 · APJ Jacqueline T Harlow · IPR · Final written decision

    Claims 1–7, 12, and 13 were not shown unpatentable because Shadle did not establish the claimed molarity and conductivity limitations, and the obviousness showing was insufficient.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “and several years of postgraduate training or practical experience in a relevant discipline such as biochemistry, process chemistry, protein chemistry, chemical engineering and/or biochemical engineering, among others.” Pet. 6 (citing Ex. 1002 ¶ 28). Petitioner further contends that “[s]uch a person would also understand that protein purification is a multidisciplinary field, and could take advantage of the specialized skills of others using a collaborative approach.” Id. (citing Ex. 1002 ¶ 28). Patent Owner does not address Petitioner’s position on this matter and does not propose its own description for a person of ordinary skill in the art at the time of the invention. We agree with Petitioner, and adopt Petitioner’s description of the level of ordinary skill in the art at the time of invention of the ’815 patent. We also note that the applied prior art reflects a level of skill at the time of the claimed invention consistent with our determination. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

      “Consistent with the Institution Decision, we determine that “the plain language of the claims, as well as the specification of the ’815 patent, indicates that the term ‘molarity’ refers to the total concentration of solute present in the solution, rather than the concentration of one particular solute.” Id. at 10–11. The claims of the ’815 patent refer consistently to the overall molarity of solutions, and not of any particular solute in a given solution. For example, claim 1 requires “an acidic aqueous solution of low conductivity . . . having a molarity of 100 mM or less” (Ex. 1001, 12:42–44 (emphasis added)), and further recites that the molarity of the “adjusted sample is 100 mM or less” (id. at 12:45–47 (emphasis added)). Claim 2 9 similarly limits the molarity of the “acidic aqueous solution.” Id. at 12:50– 52. Notably, these claims do not identify any particular solute to which the term molarity refers; rather, the claims of the ’815 patent describe solutions having certain characteristics, of which solution molarity is one. As we stated in our Institution Decision: Similarly, the specification of the ’815 patent refers to the molarity of the complete solution, rather than one solute in that solution. See, e.g., id. at 4:61–64 (“As used herein, a ‘neutral aqueous solution . . .’ generally refers to an aqueous solution . . . which has a molarity of 0 to 100mM”), 5:28–31 (“an ‘acidic aqueous solution of low conductivity’ generally refers to an aqueous solution . . . , which has a molarity of 0 to 100 mM”). The file history of the ’815 patent likewise references the molarity of the solution, rather than of a given solute in the solution. See e.g., Ex.1005, 82 (“an important feature of the present invention is to adjust pH value of the solution, the eluate, to from 4 to 8 while maintaining the molarity of the solution at 100mM or less.”), 107 (“0.1 M buffer was used as an eluent, and 1 M Tris-HCl was used to adjust the pH of the eluted fraction, that is, the fact that 0.1 M and 1 M solutions were used means that the molarity of the eluted fration [sic] must be over 0.1 M (100 mM)”). Inst. Dec. 11.” slip op. at 9

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

      “In the Institution Decision, we concluded that the claim terms “conductivity” and “ionic strength,” for which Petitioner proffered constructions in its Petition (Pet. 30, 35–36), did not require express construction for purposes of this proceeding. Dec. 8. Neither Petitioner nor Patent challenges that determination. See PO Resp. 11–22; Reply, passim. In its Response, Patent Owner proposes constructions for several additional 11 terms. Namely, Patent Owner contends that the preambles of claims 1 and 13 should be construed as limiting (PO Resp. 12), “to form particles” should be construed to require that the solution becomes clouded (id. at 16), and “the treated sample containing a physiologically active protein,” as recited in claim 5, should be interpreted to mean “the sample resulting from performing the method of claim 1, which concludes with removing particles in step 3” (id. at 17). Because interpretation of these claim terms is not necessary to our anticipation or obviousness analyses, we need not construe them. See Nidec, 868 F.3d at 1017.” slip op. at 11

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

      “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either expressly or inherently. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1341 (Fed. Cir. 2016). “To establish that a prior art reference inherently—rather than expressly— discloses a claim limitation, ‘the limitation at issue necessarily must be present, or [is] the natural result of the combination of elements explicitly disclosed by the prior art.’” Endo Pharm. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018) (alteration in original) (quoting PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014)). Inherency, however, 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.” slip op. at 14

    Patent outcomesUS 7,927,815 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,927,815
  • PTAB · Nov 28, 2018 · IPR2017-01357 · APJ Jacqueline T Harlow · IPR · Final written decision

    Claims 1–8 and 13 were not held unpatentable because Petitioner failed to prove anticipation by Shadle or obviousness over Shadle.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “According to Petitioner, a person of ordinary skill in the art at the time of the invention would have had “at least a graduate degree, such as a Ph.D., 6 and several years of postgraduate training or practical experience in a relevant discipline such as biochemistry, process chemistry, protein chemistry, chemical engineering and/or biochemical engineering, among others.” Pet. 6 (citing Ex. 1002 ¶¶ 28–29). Petitioner further contends that “[s]uch a person would also understand that protein purification is a multidisciplinary field, and could take advantage of the specialized skills of others using a collaborative approach.” Id. (citing Ex. 1002 ¶¶ 28–29). Patent Owner does not address Petitioner’s position on this matter and does not propose its own description for a person of ordinary skill in the art at the time of the invention. We agree with Petitioner, and adopt Petitioner’s description of the level of ordinary skill in the art at the time of invention of the ’289 patent. We also note that the applied prior art reflects a level of skill at the time of the claimed invention consistent with our determination. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 6

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

      “Consistent with the Institution Decision, we determine that “the plain language of the claims, as well as the specification of the ’289 patent, indicates that the term ‘molarity’ refers to the total concentration of solute present in the solution, rather than the concentration of one particular solute.” Id. at 10. The claims of the ’289 patent refer consistently to the overall molarity of solutions, and not of any particular solute in a given solution. For example, claim 1 requires “an acidic aqueous solution of low conductivity having a molarity of 100 mM or less” (Ex. 1001, 12:50–51 (emphasis added)), and further recites that the “molarity of the neutralized 9 eluate is 100 mM or less” (id. at 12:54 (emphasis added)). Claim 2 similarly limits the molarity of the “acidic aqueous solution.” Id. at 12:59–61. Notably, these claims do not identify any particular solute to which the term molarity refers; rather, the claims of the ’289 patent describe solutions having certain characteristics, of which solution molarity is one. As we stated in our Institution Decision: Similarly, the specification of the ’289 patent refers to the molarity of the complete solution, rather than one solute in that solution. See, e.g., id. at 4:61–66 (“As used herein, a ‘neutral aqueous solution . . .’ generally refers to an-aqueous [sic] solution . . . which has a molarity of 0 to 100mM”), 5:28–31 (“an ‘acidic aqueous solution of low conductivity’ generally refers to an aqueous solution . . . , which has a molarity of 0 to 100 mM”). The prosecution history of the ’289 patent likewise references the molarity of the solution, rather than of a given solute in the solution. See e.g., Ex.1005, 12 (“an important feature of the present invention is to adjust pH value of the solution, the eluate, to from 4 to 8 while maintaining the molarity of the solution at 100mM or less.”), 37 (“0.1 M buffer was used as an eluent, and 1 M Tris-HCl was used to adjust the pH of the eluted fraction, that is, the fact that 0.1 M and 1 M solutions were used means that the molarity of the eluted fration [sic] must be over 0.1 M (100 mM)”). Inst. Dec. 10–11.” slip op. at 9

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

      “In its Response, Patent Owner proposes constructions for several additional terms. Namely, Patent Owner contends that the preamble of claim 1 should be construed as limiting (PO Resp. 12), “to form particles” should be construed to require that the solution becomes clouded (id. at 17), and “the treated sample containing an antibody,” as recited in claim 5, should be interpreted to mean “the sample resulting from performing the method of claim 1, which concludes with removing particles in step 4” (id. 11 at 18). Because interpretation of these claim terms is not necessary to our anticipation or obviousness analyses, we need not construe them. See Nidec, 868 F.3d at 1017.” slip op. at 11

    • ExcludeOther

      “Petitioner asserts that Patent Owner untimely introduced Exhibits 2201–2207 for the first time during the deposition of Petitioner’s Reply declarant, Dr. Przybycien. Paper 36, 4. Petitioner additionally asserts that the challenged exhibits are inadmissible because they are irrelevant. Id. Patent Owner responds that the objected-to exhibits were timely introduced because they were used to challenge opinions presented by Dr. Przybycien for the first time in conjunction with Petitioner’s Reply. Paper 44, 2. Patent Owner further asserts that the exhibits are relevant because they illuminate gaps in Dr. Przybycien’s Reply testimony. Id. at 3. Because we have not relied on Exhibits 2201–2207, or Dr. Przybycien’s testimony regarding those exhibits in this Final Written Decision, we dismiss Petitioner’s Motion to Exclude Exhibits 2201–2207 as moot.” slip op. at 33

    Patent outcomesUS 7,332,289 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,332,289
  • PTAB · Nov 6, 2018 · IPR2017-01149 · APJ Karl D Easthom · IPR · Final written decision

    Claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 are unpatentable as obvious over Young ’801, Young ’121, Strubbe, and the respective additional reference in each trial.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedDenied

      “observations from that deposition or seek authorization to file a sur-reply. In view of these circumstances, we deny Patent Owner’s Motion to Exclude.” slip op. at 126

    Patent outcomesUS 6,418,556 unpatentable
    Nonecites Phillips
    Patents in suitUS 6,418,556
  • PTAB · Nov 6, 2018 · IPR2017-01150 · APJ Karl D Easthom · IPR · Final written decision

    Claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 are unpatentable as obvious over Young ’801, Young ’121, Strubbe, and Moro, Reiter, or Remillard.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

      “III. CONCLUSION For the foregoing reasons, Petitioner has shown, by a preponderance of the evidence, that the subject matter of claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 would have been obvious over the combination of Young ’801, Young ’121, Strubbe, and either Moro (48Pet.), Reiter (49Pet.), or Remillard (50Pet.).” slip op. at 126

    • ExcludeMotion to exclude, deniedDenied

      “12. Motion to Exclude Patent Owner moves to exclude paragraphs 8, 24, 27–30, 32 and 38 of” slip op. at 123

    Patent outcomesUS 6,418,556 unpatentable
    § 103 obviousnesscites Phillips
    Patents in suitUS 6,418,556
  • PTAB · Nov 6, 2018 · IPR2017-01148 · APJ Karl D Easthom · IPR · Final written decision

    Claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 are unpatentable as obvious over the stated combinations in each of the three trials.

    RulingsFinal written decision
    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “of the evidence, that the subject matter of claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 would have been obvious over the combination of Young ’801, Young ’121, Strubbe, and either Moro (48Pet.), Reiter (49Pet.), or Remillard (50Pet.). IV. ORDER ORDERED that 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 of U.S. Patent No. 6,418,556 B1 are unpatentable as a result of each trial as a separate matter, IPR2017-01148, IPR2017-01149, and IPR2017-01150;” slip op. at 126

    • ExcludeMotion to exclude, deniedDenied

      “observations from that deposition or seek authorization to file a sur-reply. In view of these circumstances, we deny Patent Owner’s Motion to Exclude.” slip op. at 126

    Patent outcomesUS 6,418,556 unpatentable
    § 103 obviousnesscites Phillips
    Patents in suitUS 6,418,556
  • PTAB · Nov 6, 2018 · IPR2017-01151 · APJ Karl D Easthom · IPR · Final written decision

    Claims 23 and 25–27 are unpatentable as obvious over Young ’801, Young ’121, Strubbe, and any one of Moro, Reiter, or Remillard.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedDenied

      “would not have interpreted Young ’801’s system as restricted to a single page limited to time slots ranging from 11:00 am to 12:30 pm as depicted in Figure 6 of Young ’801. See Ex. 1720 ¶ 24 (describing Dr. Bovik’s restricted view of Young ’801 as unreasonable). This restricted reading of Young ’801 unreasonably constrains the use of the guide to 1.5 hours, something the Petitions do not do, contrary to Patent Owner’s arguments that the Reply shifts to new theories. See Rep. Opp. Mot. Exc. 2–5. To elaborate and address Patent Owner’s arguments and Dr. Bovik’s testimony, Mr. Wechselberger responds with a citation documenting well-known cursor navigation aspects of the same concept involved in spreadsheets (Ex. 1722) and elaborates about minimal program guide layout or format changes that go hand-in-hand with the Petitions’ assertions of guide size reduction. See Ex. 1720 ¶ 24; Opp. Mot. Exc. 9–11 (discussing Ex. 1720 ¶¶ 36–37, 129– 131, 136–137, 158), 11 (noting Dr. Bovik stated in his deposition “a user would have been ‘confined to the visible screen’”) (citing Ex. 1721, 56:16– 23, 108:25–109:8, 116:17–117:2; Ex. 2706 ¶¶ 51–52). In summary, the Petition cites to portions of Young ’801 that describe the page mode and generally advance the theory of moving a cursor across, upward, and to the right to obtain consecutively displayed and successive portions of schedule information, citing portions that describe new pages and cursor jumps. Petitioner did not create a new theory about how the page guide operates but responded to Patent Owner’s arguments. Patent Owner chose not to avail itself of the opportunity to depose Dr. Wechselberger about his second declaration and thereafter file observations from that deposition or seek authorization to file a sur-reply. In view of these circumstances, we deny Patent Owner’s Motion to Exclude.” slip op. at 92

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “materially similar description of a person of ordinary skill in the art. See PO Resp. 14–15 (citing Ex. 2706 ¶¶ 1–19). During the Oral Hearing, Patent Owner indicated any differences between Petitioner’s and Patent Owner’s descriptions do not create a dispositive issue. See Tr. 66:11–18. On this record, Petitioner’s description comports with the level of ordinary skill implied by the prior art references discussed further below. Accordingly, we adopt it.” slip op. at 38

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “8. Young ’801, Young ’121, Strubbe, and Moro Petitioner persuasively shows that claims 23 and 25–27 the” slip op. at 47

    Patent outcomesUS 6,418,556 unpatentable
    § 103 obviousness
    Patents in suitUS 6,418,556
  • PTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution

    The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.

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

      “As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24

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

      “As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31

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

      “A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28

    • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached

      “support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
    Patents in suitUS 8,741,929
  • PTAB · Sep 20, 2018 · IPR2017-01053 · APJ Grace Karaffa Obermann · IPR · Final written decision

    Claims 1–28 were not shown unpatentable under § 103 because the proposed combinations lacked a persuasive reason to make the required modifications and meet the claimed limitations.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “understanding of a person of ordinary skill in the art at the time of the invention. Petitioner submits that such a person would have had a Doctorate in microbiology or chemistry (or a related field) with at least a few years of experience in the development of ophthalmic formulations. Pet. 7. Alternatively, in Petitioner’s view, that person would have had a Bachelor’s or Master’s Degree combined with significant (5 years or more) practical experience developing ophthalmic formulations. Id. Patent Owner, for its part, advances a definition that “does not differ materially” from that proposed by Petitioner. Resp. 5. Petitioner’s definition is comparable to the level of skill reflected in the asserted prior art. The prior art itself is sufficient to demonstrate the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect appropriate level of ordinary skill in the art). To the extent more specified findings are required, we adopt the definition proposed by Petitioner. Pet. 7. We observe, however, that there is no appreciable difference between the parties’ respective definitions that would “materially” alter the outcome of this decision based on our acceptance of one definition over the other. Resp. 5.” slip op. at 5

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

      “Pet. 5–7; Dec. 7–8. Patent Owner tacitly agrees. See Resp. 1 (stating that a “self-preserved” composition is “one that has sufficient antimicrobial activity to pass standard tests for ‘preservative efficacy’ without needing a conventional preservative”). Accordingly, for reasons set forth in our decision instituting review in the Apotex IPR, we determine that: (a) The preamble term “self-preserved” breathes life and meaning into the claims, and is construed as a limitation of claims 1–28; and (b) The broadest reasonable interpretation of “self-preserved” compositions is “compositions that do not contain a conventional antimicrobial preservative.” Apotex IPR, Paper 9, 5–6; Dec. 7–8. Schneider, which is asserted in each ground of unpatentability stated in the Petition, informs that edetate disodium (“EDTA”) and benzalkonium chloride (“BAC”) were conventional antimicrobial preservatives known and available at the time of the invention—an issue not meaningfully disputed by Petitioner. Ex. 1007, 7:14–21; Pet. 15. Our claim construction findings are supported by the specification of the ’299 patent, which states that “[t]he multi-dose compositions of the present invention, which do not contain a conventional antimicrobial preservative, are referred to herein as being ‘self-preserved’.” Ex 1001, 3:27–29. The specification identifies BAC as an example of a conventional antimicrobial preservative excluded from the self-preserved composition of the challenged claims. Id. at 4:23–25. No other claim term requires express construction for the purposes of this decision. See, e.g., Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only claim terms in controversy need be construed, and then only to the extent necessary to resolve the controversy).” slip op. at 7

    • Prior constructionPrior construction adoptedDecided for patent owner

      “Petitioner argues that we should adopt the claim construction resolved in the Apotex IPR, as we did in the decision on institution in this case. Pet. 5–7; Dec. 7–8. Patent Owner tacitly agrees. See Resp. 1 (stating that a “self-preserved” composition is “one that has sufficient antimicrobial activity to pass standard tests for ‘preservative efficacy’ without needing a conventional preservative”). Accordingly, for reasons set forth in our decision instituting review in the Apotex IPR, we determine that: (a) The preamble term “self-preserved” breathes life and meaning into the claims, and is construed as a limitation of claims 1–28; and (b) The broadest reasonable interpretation of “self-preserved” compositions is “compositions that do not contain a conventional antimicrobial preservative.” Apotex IPR, Paper 9, 5–6; Dec. 7–8. Schneider, which is asserted in each ground of unpatentability stated in the Petition, informs that edetate disodium (“EDTA”) and benzalkonium chloride (“BAC”) were conventional antimicrobial preservatives known and available at the time of the invention—an issue not meaningfully disputed by Petitioner. Ex. 1007, 7:14–21; Pet. 15. Our claim construction findings are supported by the specification of” slip op. at 6

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

      “Petitioner asserts that an ordinarily skilled artisan “would have retained as much of” Formulation A “as feasible, as this was already an FDA-approved formulation, marketed as Travatan®.” Pet. 15; Ex. 1002 ¶¶ 46–47. But Petitioner’s challenge incongruously depends on at least six modifications to Formulation A; seven, if attaining UPS preservative efficacy requirements is not an inherent property of the modified composition. Petitioner does not address, much less explain, how or why an ordinarily skilled artisan, undertaking those six or seven modifications, would have done so with a reasonable expectation of success in arriving at a “self-preserved” composition using zinc as the sole preservative—in a field where zinc “had never before been the sole preservative in a marketed ophthalmic drug.” Resp. 9; Ex. 2023 ¶ 46; Ex. 2025 ¶ 30. The Petition does not articulate a rational reason why a person of ordinary skill in the art, setting out to improve Formulation A, would have selected the particular combination of ingredients required by claim 1. Formulation A bears almost no resemblance to the composition of claim 1, lacking three of the four required ingredients (zinc ions, sorbitol, and propylene glycol) and containing two others (BAC and EDTA) that are excluded by the “self-preserving” terms of the claim. Compare Ex. 1001, claim 1, with Ex. 1007, 9:25–42 (Table, Formulation A). And even if we set aside those hurdles, the challenge fails for lack of persuasive evidence showing how or why an ordinarily skilled artisan would have resolved to include the claimed ingredients in the specified concentrations, while at the same time limiting anionic species (to the extent included) to a concentration of “less than 15 mM.” Ex. 1001, claim 1. Petitioner fails to establish that the subject matter of claim 1 would have been obvious over the combined disclosures of Schneider, Xia, and Chowhan—with or without the additional disclosure of Gadd. Pet. 2–3.” slip op. at 26

    Patent outcomesUS 8,268,299 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 8,268,299
  • PTAB · Sep 10, 2018 · IPR2017-00934 · APJ Stacy B Margolies · IPR · Final written decision

    Claims 1, 4–11, and 14–24 are unpatentable as obvious; claims 2, 3, 12, and 13 were not shown unpatentable.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “B. Level of Ordinary Skill in the Art In determining whether an invention would have been obvious at the” slip op. at 8

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “shows the relation between the content being display and the current time, Petitioner shows that a person of ordinary skill in the art would have been motivated to incorporate Vallone’s teachings to improve the interface by making it visually intuitive and interactive. Ex. 1011 ¶¶ 158, 159, 171, 177, 178. Dr. Rhyne’s testimony is credible and persuasively supported by the teachings of the underlying references. See Ex. 1011 ¶¶ 158, 159, 171, 177, 178; Ex. 1002 ¶¶ 6, 7, 88, 142; Ex. 1003, Fig. 26, 1:44–49, 1:53–57, 18:32– 44, 19:1–3, 20:19–22. For example, as stated above, Vallone expressly discloses applying its interactive trick play bar more broadly to any device in which physical position in the material is readily ascertainable, such as a VCR. Ex. 1003, 20:19–22. In addition, Vallone describes the known problem of multimedia devices lacking interactivity and intuitive devices. Ex. 1003, 1:11–49. One of ordinary skill in the art would have been aware of this problem and motivated to improve Wood’s digital VCR accordingly. Ex. 1011 ¶¶ 158, 159, 171, 177, 178. In addition, as Dr. Rhyne explains, an ordinarily skilled artisan would have been motivated to combine the teachings of the references to provide a single consistent interface for the” slip op. at 22

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

      “shows the relation between the content being display and the current time, Petitioner shows that a person of ordinary skill in the art would have been motivated to incorporate Vallone’s teachings to improve the interface by making it visually intuitive and interactive. Ex. 1011 ¶¶ 158, 159, 171, 177, 178. Dr. Rhyne’s testimony is credible and persuasively supported by the teachings of the underlying references. See Ex. 1011 ¶¶ 158, 159, 171, 177, 178; Ex. 1002 ¶¶ 6, 7, 88, 142; Ex. 1003, Fig. 26, 1:44–49, 1:53–57, 18:32– 44, 19:1–3, 20:19–22. For example, as stated above, Vallone expressly discloses applying its interactive trick play bar more broadly to any device in which physical position in the material is readily ascertainable, such as a VCR. Ex. 1003, 20:19–22. In addition, Vallone describes the known problem of multimedia devices lacking interactivity and intuitive devices. Ex. 1003, 1:11–49. One of ordinary skill in the art would have been aware of this problem and motivated to improve Wood’s digital VCR accordingly. Ex. 1011 ¶¶ 158, 159, 171, 177, 178. In addition, as Dr. Rhyne explains, an ordinarily skilled artisan would have been motivated to combine the teachings of the references to provide a single consistent interface for the” slip op. at 22

    Patent outcomesUS 8,768,147 mixed
    § 103 obviousnesscites Graham
    Patents in suitUS 8,768,147
  • PTAB · Jul 27, 2018 · IPR2018-00125 · APJ Richard J Smith · IPR · Rehearing

    The Board denied rehearing of its § 325(d) denial of institution for claims 1–12 challenged as obvious over Sofia ’634 and Congiatu.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., Inc., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d). The Board did not overlook or misapprehend Petitioner’s arguments; the Board considered them, but was not persuaded by them. We briefly address Petitioner’s contentions below.” slip op. at 2

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

      “teachings that are not present in Sofia ‘634 and are thus materially additive over the evidence that was of record during prosecution.” See Req. Reh’g 2–7. However, Petitioner’s request for rehearing fails to identify where in the Petition those additional teachings of Congiatu were addressed. See 37 C.F.R. § 42.71(d). Moreover, Petitioner’s arguments regarding Congiatu, that it relied on in the Petition, were expressly noted in the Decision as similar to Petitioner’s arguments regarding Sofia ’634. Dec. 16–17. Dr. Fortunak’s Declaration” slip op. at 3

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “and overlooked Dr. Fortunak’s expert testimony.” See Req. Reh’g 5–6. To the contrary, the Board considered Dr. Fortunak’s declaration and accorded it appropriate weight. First, contrary to Petitioner’s contention, the fact that the Decision pointed out that Dr. Fortunak’s statement regarding unexpected results (Ex. 1002 ¶ 124) was verbatim to Petitioner’s argument (Dec. 16–17) does not mean the Board ignored Dr. Fortunak’s statement. Second, contrary to Petitioner’s contention that the Board did not cite any evidence contradicting Dr. Fortunak’s opinions, the Board cited extensively to the prosecution history – including the Reasons for Allowance – of the ’309” slip op. at 3

    Discretionary denial
    Patents in suitUS 8,633,309
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