- Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd.No claims unpatentablePTAB · Nov 28, 2017 · IPR2016-01096 · APJ Lora M Green · IPR · Final written decision
Claims 1–13 and 17–23 were not shown unpatentable because Petitioner did not prove the claimed viscosity was necessarily present in either obviousness combination.
RulingsFinal written decision- BurdenNot shown unpatentable
“In that regard, we note that Petitioner must “meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis—the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc., 773 F.3d at 1195‒ 96.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In the Institution Decision, we determined that none of the terms in the challenged claims require express construction at that time. Dec. Inst. 6 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (noting that only claim terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy)); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Petitioner offers explicit constructions of several claim terms (Pet. 19‒22), as did Patent Owner in its Preliminary Response (Prelim. Resp. 9‒12). In its full Response, Patent Owner states that there is no need to expressly construe any of the claim terms. PO Resp. 13‒14. On the present record, we agree with Patent Owner and determine that none of the claim terms require explicit construction for purposes of this Decision.” slip op. at 7
- Skill levelOther
“We conclude that, for practical purposes, there is little difference between Petitioner’s and Patent Owner’s definitions of the ordinary artisan. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition. In addition, the level of ordinary skill in the art in this case is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“Patent Owner argues also that objective indicia of non-obviousness, such as unexpected results and commercial success support the patentability of the challenged claims. PO Resp. 59‒61. As we conclude that the preponderance of evidence of record does not support Petitioner’s obviousness challenge, we need not address Patent Owner’s evidence of secondary indicia.” slip op. at 29
Patent outcomesUS 6,667,061 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,667,061 - Green Cross Corporation v. Shire Human Genetic Therapies, Inc.No claims unpatentablePTAB · Mar 22, 2017 · IPR2016-00258 · APJ Robert A Pollock · IPR · Final written decision
The Board held claims 1–3, 16, and 17 not shown unpatentable under § 103 because Jin was not prior art.
RulingsFinal written decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artDecided for patent owner
“are unpatentable, which includes the burden of establishing that any reference upon which it relies constitutes prior art under 35 U.S.C. § 102. 35 U.S.C. § 316(e); see Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576 (Fed. Cir. 1996) (holding that the challenger “bore the burden of persuasion . . . on all issues relating to the status of [the asserted reference] as prior art”). However, because Petitioner offered Jin into evidence, which qualifies on its face as prior art under §102(e), Patent Owner bears the burden of producing evidence supporting a date of invention prior to the critical date of Jin. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–80 (Fed. Cir. 2015). As discussed below, Patent Owner elected to antedate, and thereby remove, Jin as prior art by showing that the inventor actually reduced the claimed invention to practice prior to Jin’s 102(e) priority date(s). As a result, the burden of production returned to Petitioner to demonstrate that the invention set forth in the challenged claims was not actually reduced to practice as of the date alleged. Id. at 1380. In order to establish an inventor’s actual reduction to practice, Patent Owner must show: (1) construction of an embodiment meeting all limitations of the challenged claims; (2) that the invention would work for its intended purpose, and (3) sufficient evidence to corroborate the inventor’s testimony. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006). “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.” Id. at 1170 (citation omitted). “[I]t is not[, however,] necessary to produce an actual over-the-shoulder observer. Rather, sufficient circumstantial evidence of an independent nature can satisfy the corroboration requirement. Furthermore, an actual reduction to practice does not require corroboration for every factual issue contested by the parties.” Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998) (internal citations omitted). “[E]ach corroboration case must be decided on its own facts with a view to deciding whether the evidence as a whole is persuasive.” Id. at 1331 (citation omitted),” slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“provided sufficient evidence to show that it reduced to practice an embodiment encompassing all elements of the challenged claims prior to the critical date of Jin, and Petitioner does not convince us otherwise. Accordingly, we find that Jin is not § 102(e) prior art, as Petitioner contends. Because Petitioner’s ground for challenging the ’556 Patent as obvious depends on Jin, we conclude that Petitioner has not proven by a preponderance of the evidence that the challenged claims are unpatentable. F.” slip op. at 24
- ExcludeMotion to exclude, deniedDenied
“Motions i. Patent Owners Motion to Exclude Evidence (Paper 74) Patent Owner moves to exclude Exhibits 1035, 1036, 1037, 1038, 1039, 1400, 1049, and 1051, each of which relates to Petitioner’s obviousness case. As discussed above, Petitioner has failed to satisfy the threshold issue of demonstrating that Jin, the primary reference relied upon in its obviousness ground, is prior art to the ’556 Patent. Accordingly, we do not address the substance of Petitioner’s obviousness arguments and, thus, do not rely on the challenged exhibits in our analysis. Accordingly, we deny Patent Owner’s Motion as moot. ii. Petitioner’s Motion to Exclude Evidence (Paper 75) Petitioner moves to exclude Exhibit 2207 (“Webb Exhibit 4”) which is purportedly an unredacted version of the TKT report (Exhibit 2115). See Paper 81, 1. As we have no need to rely on the challenged exhibit or associated testimony in our analysis, Petitioner’s motion is denied as moot.” slip op. at 24
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“iii. Petitioner’s Request for Expungement of Papers 71 and 72 In its Response to Patent Owner’s Motions for Observations Regarding Cross-Examination of Drs. Carbonell and Webb, Petitioner requests that we expunge, or accord no weight to, Patent Owner’s Motions for Observations because Patent Owner “made no effort to faithfully quote any testimony, and its ‘observations,’ which are often crammed with multiple citations, improperly narrate and mischaracterize the testimony cited, are rife with legal argument, and include references to unauthorized exhibits.” Paper 80, 1–3 (footnotes omitted); Paper 82, 1–3 (same). Although we are not convinced that Patent Owner “color[s] so far outside the lines” as Petitioner contends, we do not rely in our analysis on Patent Owner’s Motions for Observations. Accordingly, Petitioner’s request is denied as moot.” slip op. at 25
Patent outcomesUS 9,051,556 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 9,051,556 - Ariosa Diagnostics, Inc. v. Illumina, Inc.No claims unpatentablePTAB · Jan 7, 2016 · IPR2014-01093 · APJ Lora M Green · IPR · Final written decision
Claims 1–22 were not shown unpatentable under § 102 because Ariosa did not prove Fan was prior art to the ’794 patent.
RulingsFinal written decision- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“Moreover, Petitioner did not meet that burden as it did not demonstrate that Fan was entitled to the effective filing date of the ’810 provisional, as it failed to demonstrate that the claims of Fan were supported by the disclosure of the ’810 provisional in compliance with 35 U.S.C. § 112, first paragraph. Thus, Petitioner did not meet its burden of persuasion of demonstrating that Fan is prior art to the ’794 patent, and, thus, could not demonstrate by a preponderance of the evidence that Fan anticipates the challenged claims.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Moreover, Petitioner did not meet that burden as it did not demonstrate that Fan was entitled to the effective filing date of the ’810 provisional, as it failed to demonstrate that the claims of Fan were supported by the disclosure of the ’810 provisional in compliance with 35 U.S.C. § 112, first paragraph. Thus, Petitioner did not meet its burden of persuasion of demonstrating that Fan is prior art to the ’794 patent, and, thus, could not demonstrate by a preponderance of the evidence that Fan anticipates the challenged claims.” slip op. at 14
- ExcludeMotion to exclude, deniedDenied
“D. Patent Owner’s Motion to Exclude (Paper 52) In its Motion to Exclude, Patent Owner seeks to exclude Exhibits 1035–1037, 1039–1044, and 1047–1052. As we do not rely on those Exhibits in this Decision, Patent Owner’s Motion to Exclude is dismissed as moot.” slip op. at 16
Patent outcomesUS 7,955,794 not shown unpatentable§ 102 anticipationPatents in suitUS 7,955,794 - Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.No claims unpatentablePTAB · Dec 9, 2014 · IPR2013-00371 · APJ Scott E Kamholz · IPR · Final written decision
Claims 1–13 and 17–20 were not shown unpatentable as obvious over Ashley ’932 and Sheth because Sheth did not disclose a delayed-release portion or the claimed IR:DR ratios.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“agree with Amneal that the broadest reasonable construction of “delayed release,” in light of the specification of the ’405 patent, is not limited to formulations requiring that there be no substantial release in the stomach. The portion of the ’405 patent specification upon which Supernus relies to support its narrower construction addresses properties of “enteric coated pellets,” not a delayed-release component. Ex. 1007, 7:56. The ’405 patent discloses formats other than enteric coated pellets, such as an “uncoated matrix tablet,” as being delayed-release components. Id. at 5:38–40 (“delayed-release portion can be . . . uncoated matrix tablet.”). Consequently, properties of enteric coated pellets do not address the full scope of “delayed release” as that term is used in the ’405 patent. We will not read the limitations of an embodiment, even a preferred embodiment, into the construction of a claim term that is plainly used elsewhere in the specification more broadly. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). As Supernus concedes, Tr. 42:7–9, the ’405 patent does not provide an express definition of “delayed release.” We turn, therefore, to other evidence of how the term is understood and used by persons of ordinary skill in the art. We find, upon consideration of this evidence, that the term “delayed release” is used, more-or-less uniformly, to refer to formats that allow for release of a drug only after some delay following oral administration. See, e.g., Ex. 2058, 30 (quoted supra); Ex. 2047, 7 (defining “delayed release” as “release of a drug (or drugs) at a time other than promptly after administration”);4 Ex. 2016 ¶ 106 (citing definition of “delayed release” in Ashley ’854, quoted supra, with approval). Those definitions are consistent with one another, both parties and their experts cite them with favor, and we discern nothing in the use of the term “delayed release” in the ’405 patent specification that is inconsistent with those definitions or more limiting than them. For these reasons, we determine that the broadest reasonable construction of “delayed release,” consistent with the ’405 patent, is “release of a drug at a time other than immediately following oral administration.” See Ex. 2058, 30; Ex. 2047, 7; Ex. 1003, 11:4–6.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“water-soluble polymer in the coating of Sheth’s secondary loading portion results in release of drug promptly after administration. See Ex. 2016 ¶ 172. Amneal does not cite credible evidence to refute Dr. Rudnic’s testimony. Although Dr. Rudnic conceded that there must be some lag while the polymer hydrates, we further credit his testimony that this lag, essentially the time required to wet the material, would not be considered a “delay.” See Ex. 1052, 248:3–5. We agree with Dr. Rudnic that dissolution, however rapid, necessarily requires some finite amount of time to allow interaction of the solvent and the solute. See Ex. 1005, 5:1–2. Amneal does not explain why we should not credit all of Dr. Rudnic’s testimony on this point. Because we credit Dr. Rudnic’s testimony, we agree with Supernus that Sheth’s secondary loading portion is not a “delayed release” portion. A “delayed release” format, when that term is construed to mean “release of a drug at a time other than immediately following oral administration,” specifically excludes formats that result in release of drug starting immediately after oral administration. To conclude otherwise would read the phrase “delayed release” out of the claim. See In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) (all limitations of a claim must be considered when considering patentability over prior art). Amneal has not explained how there is any appreciable delay in the onset of drug release from the secondary loading portion once water in the patient’s saliva or gastric fluid has begun to solubilize the pH-insensitive polymer in the coating.6” slip op. at 13
- ExcludeMotion to exclude, deniedDenied
“MOTION TO EXCLUDE EVIDENCE Amneal moves to exclude Supernus Exhibits 2028, 2029, 2032–2034, 2039, 2049, 2050, 2147, 2149–2154, and 2156. Pet. Motion to Exclude 1. We dismiss Amneal’s motion as moot, because we do not rely on any of the objected-to evidence in our final decision. IV.” slip op. at 15
Patent outcomesUS 8,394,405 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,394,405 - Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.No claims unpatentablePTAB · Dec 9, 2014 · IPR2013-00368 · APJ Scott E Kamholz · IPR · Final written decision
Amneal did not prove claims 1, 2, 5–15, and 19–22 unpatentable as obvious over Ashley ’932 and Sheth because Sheth did not disclose a delayed-release portion.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“agree with Amneal that the broadest reasonable construction of “delayed release,” in light of the specification of the ’740 patent, is not limited to formulations requiring that there be no substantial release in the stomach. The portion of the ’740 patent specification upon which Supernus relies to support its narrower construction addresses properties of “enteric coated pellets,” not a delayed-release component. Ex. 1001, 7:47. The ’740 patent discloses formats other than enteric coated pellets, such as an “uncoated matrix tablet,” as being delayed-release components. Id. at 5:29–31 (“delayed-release portion can be . . . uncoated matrix tablet.”). Consequently, properties of enteric coated pellets do not address the full scope of “delayed release” as that term is used in the ’740 patent. We will not read the limitations of an embodiment, even a preferred embodiment, into the construction of a claim term that is plainly used elsewhere in the specification more broadly. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). As Supernus concedes, Tr. 42:7–9, the ’740 patent does not provide an express definition of “delayed release.” We turn, therefore, to other evidence of how the term is understood and used by persons of ordinary skill in the art. We find, upon consideration of this evidence, that the term “delayed release” is used, more-or-less uniformly, to refer to formats that allow for release of a drug only after some delay following oral administration. See, e.g., Ex. 2058, 30 (quoted supra); Ex. 2047, 7 (defining “delayed release” as “release of a drug (or drugs) at a time other than promptly after administration”);3 Ex. 2016 ¶ 105 (citing definition of “delayed release” in Ashley ’854, quoted supra, with approval). Those definitions are consistent with one another, both parties and their experts cite them with favor, and we discern nothing in the use of the term “delayed release” in the ’740 patent specification that is inconsistent with those definitions or more limiting than them. For these reasons, we determine that the broadest reasonable construction of “delayed release,” consistent with the ’740 patent, is “release of a drug at a time other than immediately following oral administration.” See Ex. 2058, 30; Ex. 2047, 7; Ex. 1003, 11:4–6.” slip op. at 7
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We credit Dr. Rudnic’s declaration testimony that inclusion of a water-soluble polymer in the coating of Sheth’s secondary loading portion results in release of drug promptly after administration. See Ex. 2016 ¶ 175. Amneal does not cite credible evidence to refute Dr. Rudnic’s testimony. Although Dr. Rudnic conceded that there must be some lag while the polymer hydrates, we further credit his testimony that this lag, essentially the time required to wet the material, would not be considered a “delay.” See Ex. 1052, 248:3–5. We agree with Dr. Rudnic that dissolution, however rapid, necessarily requires some finite amount of time to allow interaction of the solvent and the solute. See Ex. 1005, 5:1–2. Amneal does not explain why we should not credit all of Dr. Rudnic’s testimony on this point.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“For this reason, we determine that Amneal has failed to show that Sheth discloses a “delayed release” portion. Amneal’s argument that Sheth discloses the claimed IR:DR ratio (or makes the claimed ratio reachable through routine experimentation) thus becomes untenable. Dr. Van Buskirk’s evidence concerning ratios in Sheth is premised on an assumption that Sheth’s secondary loading portion is a delayed release portion. See, e.g., Ex. 1022 ¶ 59 (“Additionally, the secondary loading coated pellets (the DR component) described in the ’748 patent . . .”). That assumption is unwarranted, for the reasons given above. Consequently, Sheth’s disclosure of ratios involving the secondary loading portion does not constitute disclosure of ratios involving a delayed release portion. Put another way, Amneal has failed to persuade us that the prior art it cites for disclosure of IR:DR ratios actually discloses such ratios. Without evidence that the claimed IR:DR ratio was known or could have been reached through routine experimentation, Amneal’s challenge fails. For the reasons discussed above, we conclude that Amneal has not” slip op. at 14
- ExcludeMotion to exclude, deniedDenied
“We dismiss Amneal’s motion as moot, because we do not rely on any of the objected-to evidence in our final decision. IV.” slip op. at 15
Patent outcomesUS 8,206,740 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,206,740 - Ariosa Diagnostics v. Verinata Health, Inc.No claims unpatentablePTAB · Oct 23, 2014 · IPR2013-00276 · APJ Toni R Scheiner · IPR · Final written decision
Claims 1–18 were not shown unpatentable under §103 over Shoemaker, Dhallan, and Binladen because the petition did not explain how to combine the references or what modifications were required.
RulingsFinal written decision- BurdenFwd all claims patentableNot shown unpatentable
“elements of the challenged claims can be found in Shoemaker, Dhallan, and Binladen. Pet. 41–55. For each element or clause of the claims, the claim chart purportedly identifies where some aspect of that element or clause is disclosed by one or more of the references. The Morton Declaration and the Nussbaum Declaration closely correspond to Petitioner’s claim chart in this respect. Ex. 1002 ¶¶ 99–112, Ex. 1003 ¶¶ 110–165. However, there is no mention in the Petition or the Declarations of any differences between the claimed subject matter and the prior art, beyond a single statement that “Dhallan does not teach indexing” (Ex. 1002 ¶ 104). Moreover, nowhere is it explained how one of ordinary skill in the art would go about combining the disparate elements of the references, nor is it explained what modifications one of ordinary skill in the art would necessarily have made in order to combine them.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“elements of the challenged claims can be found in Shoemaker, Dhallan, and Binladen. Pet. 41–55. For each element or clause of the claims, the claim chart purportedly identifies where some aspect of that element or clause is disclosed by one or more of the references. The Morton Declaration and the Nussbaum Declaration closely correspond to Petitioner’s claim chart in this respect. Ex. 1002 ¶¶ 99–112, Ex. 1003 ¶¶ 110–165. However, there is no mention in the Petition or the Declarations of any differences between the claimed subject matter and the prior art, beyond a single statement that “Dhallan does not teach indexing” (Ex. 1002 ¶ 104). Moreover, nowhere is it explained how one of ordinary skill in the art would go about combining the disparate elements of the references, nor is it explained what modifications one of ordinary skill in the art would necessarily have made in order to combine them.” slip op. at 11
- ExcludeMotion to exclude, deniedDenied
“Nevertheless, the Board, sitting as a non-jury tribunal with administrative expertise, is well-positioned to determine and assign appropriate weight to evidence presented. Gnosis S.P.A. v. S. Alabama Medical Science Foundation, Case IPR2013-00118, slip op. at 43 (PTAB June 20, 2014) (Paper 64). See also Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941) (“One who is capable of ruling accurately upon the admissibility of evidence is equally capable of sifting it accurately after it has been received.”). In an inter partes review, we regard it as the better course to have a complete record of the evidence to facilitate public access, as well as appellate review. See id. (“If the record on review contains not only all evidence which was clearly admissible, but also all evidence of doubtful admissibility, the court which is called upon to review the case can usually make an end of it, whereas if evidence was excluded which that court regards as having been admissible, a new trial or rehearing cannot be avoided.”). To the extent the arguments made in Petitioner’s Reply and Dr. Morton’s Second Declaration are responsive to arguments made in Patent Owner’s Response and Dr. Butte’s Declaration, we have considered the arguments and found them unpersuasive. To the extent the arguments and evidence presented in Petitioner’s Reply and Dr. Morton’s Second Declaration are not responsive and could have been presented earlier to support Petitioner’s challenge, we accord them no weight. Patent Owner’s Motion to Exclude is denied.” slip op. at 22
Patent outcomesUS 8,318,430 not shown unpatentable§ 103 obviousnesscites KSRPatents in suitUS 8,318,430 - Ariosa Diagnostics v. Verinata Health, Inc.No claims unpatentablePTAB · Oct 23, 2014 · IPR2013-00277 · APJ Toni R Scheiner · IPR · Final written decision
Claims 19–30 were not shown unpatentable under §103 over Shoemaker, Dhallan, and Binladen because the petition did not explain how to combine the references or what modifications were needed.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“claimed subject matter and the prior art, beyond a single statement that “Dhallan does not teach indexing” (Ex. 1002 ¶ 91). Moreover, nowhere is it explained how one of ordinary skill in the art would go about combining the disparate elements of the references, nor is it explained what modifications one of ordinary skill in the art would necessarily have made in order to combine them. Patent Owner argues that “[Petitioner] and its experts fail to address” slip op. at 12
- ExcludeMotion to exclude, deniedDenied
“Nevertheless, the Board, sitting as a non-jury tribunal with administrative expertise, is well-positioned to determine and assign appropriate weight to evidence presented. Gnosis S.P.A. v. S. Alabama Medical Science Foundation, Case IPR2013-00118, slip op. at 43 (PTAB June 20, 2014) (Paper 64). See also Donnelly Garment Co. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941) (“One who is capable of ruling accurately upon the admissibility of evidence is equally capable of sifting it accurately after it has been received.”). In an inter partes review, we regard it as the better course to have a complete record of the evidence to facilitate public access, as well as appellate review. See id. (“If the record on review contains not only all evidence which was clearly admissible, but also all evidence of doubtful admissibility, the court which is called upon to review the case can usually make an end of it, whereas if evidence was excluded which that court regards as having been admissible, a new trial or rehearing cannot be avoided.”). To the extent the arguments made in Petitioner’s Reply and Dr. Morton’s Second Declaration are responsive to arguments made in Patent Owner’s Response and Dr. Butte’s Declaration, we have considered the arguments and found them unpersuasive. To the extent the arguments and evidence presented in Petitioner’s Reply and Dr. Morton’s Second Declaration are not responsive and could have been presented earlier to support Petitioner’s challenge, we accord them no weight. Patent Owner’s Motion to Exclude is denied.” slip op. at 22
- Strike new argumentNew argument disregardedOther
“To the extent Petitioner’s Reply and Dr. Morton’s Second Declaration are responsive to specific points raised by Dr. Butte in his Declaration concerning the combinability of Binladen or Shoemaker with Dhallan, we are not persuaded. As discussed above, Dr. Morton acknowledged on crossexamination that Binladen’s indexing (i.e., tagging) scheme could not be used with Dhallan’s restriction-digestible amplification primers. Dr. Morton, in her Second Declaration, contends that Dhallan also teaches a number of amplification and/or detection methods which do not require the use of restriction digestible primers” (Ex. 1042 ¶¶ 17, 18), but those portions of Dhallan were not identified or discussed in the Petition or the accompanying Declarations. Moreover, although Dr. Morton asserts that “one of ordinary skill in the art would use basic common sense and not utilize the embodiments of Dhallan where restriction sites are added to the primers” (id. ¶ 32 (emphasis omitted)), Dr. Morton still does not explain how these other methods would be combined with Binladen or Shoemaker.” slip op. at 17
Patent outcomesUS 8,318,430 not shown unpatentable§ 103 obviousnesscites KSRPatents in suitUS 8,318,430
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.