- Aurobindo Pharma USA, Inc.No claims unpatentablePTAB · Dec 28, 2018 · IPR2017-01648 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–25 were not shown unpatentable over Timmins and Cheng because Petitioner did not establish that the combination would have targeted the claimed mean Tmax range.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedOther
“In the Patent Owner Response, Patent Owner acknowledged the Board’s characterization of the knowledge of an ordinarily skilled artisan as consistent with the proposals of both parties (PO Resp. 12–13), and neither party further addressed the proper level of ordinary skill in the art or disagreed with our characterization from the Institution Decision. See PO Resp., Reply. Our determination regarding the patentability of the challenged claims does not turn on the differences between the parties’ definitions. We adopt Petitioner’s assessment, but note that our conclusions would be the same under Patent Owner’s assessment. C. Testimony of Dr. Akhlaghi” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We agree with Petitioner that Dr. Akhlaghi’s qualifications and deposition testimony, when read in context, indicate that Dr. Akhlaghi is sufficiently experienced to opine on the knowledge of one of skill in the art at the time of the ’866 patent. As noted in the August 13, 2018 update to our Trial Practice Guide: An expert witness must be qualified as an expert by knowledge, skill, experience, training, or education to testify in the form of an opinion. Fed. R. Evid. 702. There is, however, no requirement of a perfect match between the expert’s experience and the relevant field. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). A person may not need to be a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). See Notice of Update to Office Patent Trial Practice Guide, 83 Fed. Reg. 156, (Aug. 13, 2018) (text of update available at https://www.uspto.gov/sites/default/files/documents/2018_Revised_Trial_Pr actice_Guide.pdf). In addition, we are well able to consider the value of an expert opinion and afford it appropriate weight. Perreira v. Secretary of the Dept. of HHS, 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“An expert opinion is no better than the soundness of the reasons supporting it.”) D. Claim Interpretation” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for patent owner
“Tmax” In our Institution Decision, we noted that the term “Tmax” appears in each of the challenged claims, and that both parties agreed that Tmax should be construed as stated in the Specification: “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours).” Inst. Dec. 7 (citing Pet. 24; Prelim Resp. 18; Ex. 1001, col. 7, ll. 49–53). We concluded that the proposed definition was consistent with the Specification and defined the claim term with reasonable clarity, deliberateness, and precision, and we adopted the parties’ construction. Neither party addressed the issue of construction of Tmax in further briefing, but the parties disagree about how Dr. Akhlaghi applied the definition in her testimony. See, eg., Pet. Reply 9–10. For purposes of analyzing the patentability of the challenged claims, we continue to interpret the term as “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours),” because that definition is consistent with the Specification, and because the parties themselves agreed to the definition of Tmax. Inst. Dec. 7. E. Overview of the Prior Art slip op. at 11
- BurdenNot shown unpatentable
“Based on our review of the record, we determine that Petitioner has not shown sufficiently that combining the teachings of Timmins and Cheng as Petitioner contends would have resulted in a dosage form that provides a mean Tmax of metformin from 5.5 to 7.5 hours after administration.” slip op. at 19
Patent outcomesUS 6,866,866 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,866,866 - Comcast Cable Communications, LLC v. Rovi Guides, Inc.All claims unpatentablePTAB · 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 unpatentableNonecites PhillipsPatents in suitUS 6,418,556 - Comcast Cable Communications, LLC v. Rovi Guides, Inc.All claims unpatentablePTAB · 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 PhillipsPatents in suitUS 6,418,556 - Comcast Cable Communications, LLC v. Rovi Guides, Inc.All claims unpatentablePTAB · 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 PhillipsPatents in suitUS 6,418,556 - Comcast Cable Communications, LLC v. Rovi Guides, Inc.All claims unpatentablePTAB · 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 obviousnessPatents in suitUS 6,418,556 - Argentum Pharmaceuticals LLC v. Alcon Research, Ltd.No claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 8,268,299 - Coherus Biosciences, Inc. v. Hoffmann-Laroche Inc.Rehearing deniedPTAB · Jul 13, 2018 · IPR2017-02066 · APJ Wesley B Derrick · IPR · Rehearing
The Board denied rehearing and left in place the denial of institution because Petitioner did not consistently define the claimed hinge or show an abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW 37 C.F.R. § 42.71(d) provides that: A party dissatisfied with a decision . . . may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, opposition, or a reply. See also Office Trial Practice Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14, 2012). Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” 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).” slip op. at 3
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“matters in construing the claims does not address our reasoning set forth in the decision. Contrary to Petitioner’s contentions, we did not construe the claims to be limited to fusion proteins comprising a hinge having the full amino acid sequence encoded by the corresponding hinge exon, including three cysteine residues. Although we did construe the claims to exclude “any protein with less than all of the amino acid sequence of the hinge domain of human IgG (or IgG1) immunoglobulin heavy chain, even if functional,” see Dec. 7, we could not discern from Petitioner’s discussion of the claims and the art any consistent demarcation in the amino acid sequence of human IgG (or IgG1) concerning where the first domain ends and the hinge domain begins. As we explained, the phrase “all of the domains of the constant region . . . other than the first domain of said constant region” leaves unsettled “where in the constant region the divide lies between the first domain of the constant region and the hinge domain.” Dec. 7–8. What is settled, however, is that the ordinary and customary meaning of the terms in the phrase requires that all constant region amino acid sequence that is not part of the first domain must be included in the fusion protein. Id. at 7. As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained:” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained: [W]ith respect to Zettlmeissl, Petitioner appears to assert that “all of the hinge domain” requires the hinge segment encoded by the hinge exon, including three cysteine residues. But with respect to Watson, Petitioner appears to assert that “all of the hinge domain” simply requires a portion of sequence that includes the two cysteine residues involved in joining the heavy chains. Id. at 14. Notwithstanding the apparent differences in amino acid sequence, unacknowledged in the Petition, “Petitioner relies on Zettlmeissl and Watson as teaching the use of the same, identical portion of the IgG heavy chain, and relies on that portion for use in the fusion protein.” Id. at 10 (citing Pet. 5); see also id. at 6, 12–14, Pet. 5 (stating “both [Watson and Zettlmeissl] reported optimal results by employing the identical portion of the IgG heavy chain as claimed in the ’182 patent”).” slip op. at 5
Claim constructionPatents in suitUS 8,063,182 - Coherus Biosciences, Inc. v. Hoffmann-Laroche Inc.Rehearing deniedPTAB · Jul 13, 2018 · IPR2017-01916 · APJ Wesley B Derrick · IPR · Rehearing
The Board denied rehearing, leaving in place the denial of institution for claims 1–36 of the ’182 patent and claims 1–10 of the ’522 patent because Petitioner did not show an abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW 37 C.F.R. § 42.71(d) provides that: A party dissatisfied with a decision . . . may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, opposition, or a reply. See also Office Trial Practice Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14, 2012). Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” 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).” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained: [W]ith respect to Zettlmeissl, Petitioner appears to assert that “all of the hinge domain” requires the hinge segment encoded by the hinge exon, including three cysteine residues. But with respect to Watson, Petitioner appears to assert that “all of the hinge domain” simply requires a portion of sequence that includes the two cysteine residues involved in joining the heavy chains. Id. at 14. Notwithstanding the apparent differences in amino acid sequence, unacknowledged in the Petition, “Petitioner relies on Zettlmeissl and Watson as teaching the use of the same, identical portion of the IgG heavy chain, and relies on that portion for use in the fusion protein.” Id. at 10 (citing Pet. 5); see also id. at 6, 12–14, Pet. 5 (stating “both [Watson and Zettlmeissl] reported optimal results by employing the identical portion of the IgG heavy chain as claimed in the ’182 patent”).” slip op. at 5
- BurdenDecided for patent owner
“As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained: [W]ith respect to Zettlmeissl, Petitioner appears to assert that “all of the hinge domain” requires the hinge segment encoded by the hinge exon, including three cysteine residues. But with respect to Watson, Petitioner appears to assert that “all of the hinge domain” simply requires a portion of sequence that includes the two cysteine residues involved in joining the heavy chains. Id. at 14. Notwithstanding the apparent differences in amino acid sequence, unacknowledged in the Petition, “Petitioner relies on Zettlmeissl and Watson as teaching the use of the same, identical portion of the IgG heavy chain, and relies on that portion for use in the fusion protein.” Id. at 10 (citing Pet. 5); see also id. at 6, 12–14, Pet. 5 (stating “both [Watson and Zettlmeissl] reported optimal results by employing the identical portion of the IgG heavy chain as claimed in the ’182 patent”).” slip op. at 5
NonePatents in suitUS 8,163,522 - Acrux DDS Pty Ltd. / Acrux Limited et al. v. Kaken Pharmaceutical Co., Ltd. And Valeant Pharmaceuticals International, Inc.All claims unpatentablePTAB · Jun 6, 2018 · IPR2017-00190 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1 and 2 are unpatentable under § 103 over the Kaken Abstracts combined with JP ’639, the ’367 patent, or Hay.
RulingsFinal written decision- BurdenNot shown unpatentable
“what is required to establish a prior reduction to practice by the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) is instructive. 437 F.3d 1157 (Fed. Cir. 2006). The Federal Circuit sets forth the following three criteria for Patent Owner to establish an actual reduction to practice: (1) construction of an embodiment or performance of a method that met all the limitations of the claim; (2) a determination that the invention would work for its intended purpose; and (3) sufficient evidence to corroborate inventor testimony regarding these events. Id. at 1169; see also In re NTP, Inc., 654 F.3d 1279, 1291 (Fed. Cir. 2011) (“Sufficiency of corroboration is determined by using a ‘rule of reason’ analysis, under which all pertinent evidence is examined when determining the credibility of an inventor’s testimony.”) (quoting Medichem, 437 F.3d at 1170). The Federal Circuit provides the following further clarity on what is required to be corroborated. For purposes of conceptual clarity, as well as clarity of language, it should be noted that no similar condition of “corroboration” is imposed on an inventor’s notebook, or indeed on any documentary or physical evidence, as a condition for its serving as evidence of reduction to practice. Of course, the credibility (and therefore the corroborative value) of an inventor’s notebook may vary. Nevertheless, a notebook, unlike the oral testimony of an inventor, may be weighed, for whatever it is worth, in the final determination of reduction to practice. However, in a case involving reduction to practice, an unwitnessed notebook is insufficient on its own to support a claim of reduction to practice. Once properly admitted into evidence, documentary and physical evidence is assigned probative value and collectively weighed to determine whether reduction to practice has been achieved. This is what is meant by the maxim that documentary and physical evidence to not require “corroboration.”” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“the combination of the teaching of the nail lacquer references and the Kaken Abstracts, namely, the difficulty of treating tinea unguium because of the lack of ability of antifungal agents to penetrate the keratinuous layers of the nail. Pet. 43. Relying on testimony by Dr. Walters, Petitioner states that “[a] person of ordinary skill in the art would have been motivated to improve the compositions and topical application method of JP’639 using potent azole antifungal compounds that are effective against the microorganisms that cause onychomycosis and that are not inactivated by keratin.” Pet. 43–44; Ex. 1005 ¶ 131. Dr. Walters makes similar statements with regard to the ’367 patent and Hay, for instance, relying on Hay’s statement that “cures of onychomycosis are possible after topical therapy” and may result from topical therapy alone. See Pet. 48 (stating “a person of ordinary skill in the art would have been motivated to treat onychomycosis with topical therapy, and would have been motivated to find the best antifungal agent for such topical therapy”); Ex. 1005 ¶ 138; Pet. 52 (same regarding combination with Hay); Ex. 1005 ¶ 145.” slip op. at 38
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (quotation and emphasis omitted). In evaluating the import of Patent Owner’s secondary considerations evidence on whether the challenged claims would have been obvious, we apply a presumption of nexus between the secondary considerations and the challenged claims when the Patent Owner “shows that the asserted objective evidence is tied to a specific product and that product ‘is the invention disclosed and claimed in the patent.’” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1329 (Fed. Cir. 2016) (citation omitted). That presumption, however, is rebuttable. Id. (1) presumption of nexus and scope of challenged claims Here, we determine that Patent Owner is entitled to a presumption of a nexus between secondary considerations relating to Jublia® and the subject matter of the challenged claims because Patent Owner has shown that the secondary considerations are tied to a specific product, Jublia®, that is covered by challenged claims 1 and 2. See PO Resp. 60; Ex. 1043, 1. We find, however, that Petitioner has rebutted the presumption of nexus as discussed below. slip op. at 42
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner
“Patent Owner’s evidence, however, links the alleged unexpected results for topical use of efinaconazole with the unclaimed feature of being a monotherapy where nail management, such as debridement, is not required. See Ex. 1001, 17:33–18:32 (claims 1 and 2 employ the open transitional term “comprises”). Petitioner also provides evidence that we credit that Jublia®’s efficacy was only incremental over that of Penlac®. See Reply 20; Ex. 1504, 4 (FDA stating concerning efinaconazole solution for the treatment of onychomycosis that preliminary efficacy analysis “claims to show a primary efficacy response rate of about 16%, which is similar to at least one currently approved therapy” and “[a]pproximately 85% of subjects would fail to respond to your proposed treatment”); Ex. 1510 ¶ 72 (stating Jublia®’s clinical trials involved patients with less severe nail involvement than Penlac® and also utilized other topical antifungals for tinea pedis indicating “a higher efficacy rate for Jublia® could have reasonably been expected simply based on these study design differences”); see also Ex. 1510 ¶ 69 (stating “Jublia® is only indicated for patients having mild to moderate cases of onychomycosis, i.e. ‘patients 18 years and older (18 to 70 years of age) with 20% to 50% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement’”). We conclude that Patent Owner’s evidence of unexpected results is weak and insufficient to support the nonobviousness of the challenged claims.” slip op. at 47
Patent outcomesUS 7,214,506 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,214,506 - Hyperbranch Medical Technology, Inc. v. Incept LLCAll claims unpatentablePTAB · Apr 9, 2018 · IPR2016-01836 · APJ Kristi L R Sawert · IPR · Final written decision
Claims 1–6 and 8–12 are unpatentable as obvious under § 103 over Rhee ’500 or Rhee ’587, each combined with Bass or Tse.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Upon review of the parties’ respective definitions of a person of ordinary skill in the art, we adopt Petitioner’s definition as a person with either: (1) a Ph.D. in the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and having at least one year of educational or work experience in the synthesis and development of biocompatible polymer materials; (2) a bachelor’s degree in in [sic] the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and at least two years of work experience in the synthesis and development of biocompatible polymer materials; or (3) any education and experience equivalent to (1) or (2). Pet. 22 (citing Ex. 1003 ¶ 49). We find that Patent Owner’s definition of the ordinarily skilled artisan, i.e., a person having “a Ph.D. degree, or equivalent education, in polymer chemistry, or a bachelor of science degree in chemistry or a closely related field and several years of experience in the development and manufacture of polymer materials for use as tissue sealants,” PO Resp. 15–16 (citing Ex. 2006 ¶ 27), does not differ materially from Petitioner’s definition. Furthermore, our analysis would be the same under either parties’ definition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“1. “visualization agent” In its Petition, Petitioner proposed interpretations of certain claim terms. Pet. 18–22. The Board determined in its Institution Decision, however, that only the term “visualization agent” required express interpretation. Inst. Dec. 8 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). The Board set forth the broadest reasonable interpretation of “visualization agent” as “an agent that reflects or emits light at a wavelength detectable to a human eye so that a human eye may visualize the hydrogel coating.” Id. at 9. Neither party challenges that interpretation. See, e.g., Third Tr. 6:15–17. We have reassessed that determination in light of the arguments and evidence adduced at trial, and maintain that determination based on the full record.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation omitted). “Conversely, a preamble is not limiting where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Id. Here, we determine that the preamble phrase “suitable to coat a tissue of a patient” is not merely a statement of purpose, but instead represents the “essence or a fundamental characteristic of the claimed invention.” Vizio, Inc. v. Int’l Trade Com’n, 605 F.3d 1330, 1340 (Fed. Cir. 2010). In Vizio, the Federal Circuit held that a preamble reciting “for decoding” certain data “is properly construed as a claim limitation” because the apparatus and method claims reciting that preamble “would have little meaning without the intended objective of decoding.” Id. at 1341. Similarly here, we determine that the method step of claim 1—namely, mixing reactive nucleophilic precursor species, electrophilic precursor species, and a visualization agent—would have little meaning without the intended objective of forming a hydrogel coating on the tissue of a patient. Put differently, there would be no reason to perform the method step of claim 1 but for forming a hydrogel coating on the patient’s tissue. See Ex. 1001, 39:56–40:2 (claim 1) (providing that the reactive precursors crosslink after contact with the tissue to form a hydrogel in the form of a coating). Thus, we determine that “suitable to coat a tissue of a patient” is limiting in this case because it gives “life and meaning” to method claim 1. We further find that the arguments and evidence in this case show that skilled artisans would reasonably interpret “suitable to coat a tissue of a patient” as encompassing a biocompatibility requirement. Although Petitioner correctly notes that “[n]one of challenged claims recite the term ‘biocompatible,” Petitioner acknowledges that skilled artisans understand “that hydrogels are, by their nature as water-swelled materials, known to be biocompatible.” Pet. Suppl. Br. 4–5. Petitioner’s expert, Dr. Lowman, declared that “biocompatibility is presumed as a fundamental aspect of the claimed and disclosed inventions.” Ex. 2018 ¶ 40. And in his deposition, Dr. Lowman testified that skilled artisans would understand “biocompatible” to mean that the hydrogel composition is “suitable for use and tolerated by a patient.” Ex. 2019, 13:2–11 (emphasis added). Thus, we agree with Patent Owner that “suitable to coat a tissue of a patient” reasonably encompasses a biocompatibility requirement for the hydrogel composition. slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“3. Motivation to combine the prior art references and reasonable expectation of success Even “[i]f all elements of the claims are found in a combination of prior art references,” “the factfinder should further consider whether a person of ordinary skill in the art would [have been] motivated to combine those references, and whether in making that combination, a person of ordinary skill would have [had] a reasonable expectation of success.” Merck & Cie v. Gnosis S.P.A., 808 F.3d 829, 833 (Fed. Cir. 2015). The “motivation to combine” and “reasonable expectation of success” factors are subsidiary requirements for obviousness subsumed within the Graham factors. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007).” slip op. at 28
Patent outcomesUS 7,009,034 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,009,034
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.