- Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentablePTAB · Jul 19, 2017 · IPR2016-01636 · APJ Michelle N Ankenbrand · IPR · Final written decision
Claims 1–5 and 21–24 were not shown unpatentable under either § 103 ground because the evidence did not establish a reason to make the claimed modifications with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“art. For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 23); see Resp. 6. Based on our review of the ’650 patent, the types of problems and solutions described in the ’650 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ650 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Institution Decision, we determined that “no claim term requires express construction.” Inst. Dec. 7. After reviewing the entire record developed during trial, we affirm our determination from the Institution Decision that no claim term requires express construction to resolve the parties’ dispute.” slip op. at 8
- BurdenNot shown unpatentable
“II. DISCUSSION Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish the facts supporting its challenge by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Below, we explain why Petitioner has not met its burden with respect to the challenged claims.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“On the complete record before us, we are unpersuaded that Petitioner carries its burden of demonstrating that 5-HMT has a bioavailability problem that would have motivated one of ordinary skill in the art to modify its structure. Regarding the lipophilicity profile of 5-HMT, Petitioner does not provide, or attempt to provide, any actual (as opposed to relative) data concerning the bioavailability of 5-HMT. Cf. supra § II.D.2 (Brynne comparing lipophilicity of tolterodine to lipophilicity of 5-HMT). Although data is not required, and although we do not find that absence of data alone to be fatal to Petitioner’s position on this issue, the absence of any data concerning the actual bioavailability of 5-HMT leaves Petitioner’s argument solely supported by expert testimony. We now turn to the contradictory statements of the parties’ experts. Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1.” slip op. at 30
Patent outcomesUS 6,858,650 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,858,650 - Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentablePTAB · Jul 19, 2017 · IPR2016-00510 · APJ Michelle N Ankenbrand · IPR · Final written decision
Claims 1–5 and 21–24 were not shown unpatentable under either § 103 ground because the evidence did not establish a reason to modify 5-HMT into the claimed compounds.
RulingsFinal written decision- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” Resp. 28–29 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in” slip op. at 31
- Skill levelSkill level petitioner adoptedDecided for petitioner
“art. For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 23); see Resp. 6. Based on our review of the ’650 patent, the types of problems and solutions described in the ’650 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
- ExcludeNot reached
“We do not affirmatively rely upon Exhibits 1033–34, 1036–49, or 1050–72 in our present determination. Therefore, we need not decide Patent Owner’s Motion to Exclude Exhibits 1033–34 and 1036–49 or Patent Owner’s request to expunge Exhibits 1050–72, and we dismiss the motion and request as moot.” slip op. at 51
- Strike new argumentNew argument disregardedDecided for patent owner
“Petitioner’s arguments in the Reply and at oral hearing appear to be, at best, a variation on a nominal position taken in footnote 4 of the Petition which provides: “Because the patent to the 5-HMT compound was available as of November 1997 . . . a person of skill in the art in 1998 would have been motivated to research and investigate a different compound.” Pet. 45 n.4 (citing Ex. 1003 ¶ 136). Footnote 4, however, was part of Petitioner’s Ground II argument that Johansson and its divisional application make it “more predictable that the prodrug of 5-HMT in a fumarate salt would be successfully achieved.” Id. But in the Reply, and at oral hearing, Petitioner leverages this footnote into a new argument that the oral administration of 5-HMT would have been discouraged by the existence of a prior patent disclosing the compound. Reply 9–10; Tr. 28:13–29. Such a shift in position “is foreclosed by the statute, [Federal Circuit] precedent, and Board guidelines.” Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286–87 (Fed. Cir. 2017). Additionally, we are not made aware of any authority supporting Petitioner’s argument that one of ordinary skill in the art would not have pursued oral administration of 5-HMT due to the existence of a patent on the 5-HMT compound. See also Tr. 65:23–29 (Patent Owner’s assertion that there was “no case law suggesting that persons of ordinary skill are focused on patents in deciding which steps to make”). Considering the untimely development of Petitioner’s position, the absence of factual underpinnings,19 and the lack of legal precedent, we are unpersuaded that we need to give considerable weight to Petitioner’s argument regarding the prior patent. 19 Paragraph 136 of Dr. Patterson’s Declaration, relied on to support footnote 4 of the Petition, consists of the bald assertion that “[b]ecause the 5-HMT compound would have been covered by this patent and its U.S. counterpart, a skilled drug designer and developer would recognize the need to make some changes to avoid the patent.” Ex. 1003 ¶ 136. We accord little to no weight to Dr. Patterson’s conclusory statement. See 37 C.F.R. §42.65(a).” slip op. at 23
Patent outcomesUS 6,858,650 not shown unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,858,650 - Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited et al. v. Ucb Pharma GmbHNo claims unpatentablePTAB · Jul 19, 2017 · IPR2016-01596 · APJ Michelle N Ankenbrand · IPR · Final written decision
Claims 1–5 and 21–24 were not shown unpatentable under either § 103 ground because the evidence did not establish a reason to make the claimed modifications with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“art. For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 23); see Resp. 6. Based on our review of the ’650 patent, the types of problems and solutions described in the ’650 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ650 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Institution Decision, we determined that “no claim term requires express construction.” Inst. Dec. 7. After reviewing the entire record developed during trial, we affirm our determination from the Institution Decision that no claim term requires express construction to resolve the parties’ dispute.” slip op. at 8
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” Resp. 28–29 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in his deposition, 5-HMT does not violate the Rule of Five.” Tr. 67:35–68:3; 68:17–21; see Ex. 2020, 180:14–181:14. Regarding Petitioner’s reliance on the statement in Brynne that “[t]olterodine is tenfold more lipophilic than 5-HM[T], and consequently tolterodine penetrates membranes more rapidly,” Patent Owner does not appear to dispute the substance of that statement. Although such a statement illustrates a relative relationship between the lipophilicity of 5-HMT and tolterodine, it does not demonstrate that the lipophilicity of 5-HMT would have presented an absorption problem that would have led one of ordinary skill in the art to modify 5-HMT. Even if 5-HMT were considered by one of ordinary skill in the art to be less lipophilic than tolterodine, and thereby less rapidly absorbed, the record lacks sufficient evidence regarding the actual properties of 5-HMT for us to conclude that 5-HMT’s lipophilicity would have presented a bioavailability problem.21 For these reasons, Petitioner’s assertion that 5-HMT “may have bioavailability concerns” that would have prompted one of ordinary skill in the art to modify 5-HMT is unpersuasive. Reply 13.” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“On the complete record before us, we are unpersuaded that Petitioner carries its burden of demonstrating that 5-HMT has a bioavailability problem that would have motivated one of ordinary skill in the art to modify its structure. Regarding the lipophilicity profile of 5-HMT, Petitioner does not provide, or attempt to provide, any actual (as opposed to relative) data concerning the bioavailability of 5-HMT. Cf. supra § II.D.2 (Brynne comparing lipophilicity of tolterodine to lipophilicity of 5-HMT). Although data is not required, and although we do not find that absence of data alone to be fatal to Petitioner’s position on this issue, the absence of any data concerning the actual bioavailability of 5-HMT leaves Petitioner’s argument solely supported by expert testimony. We now turn to the contradictory statements of the parties’ experts. Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring . . . would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex. 1011) discussed supra § II.D.1.” slip op. at 30
Patent outcomesUS 6,858,650 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,858,650 - 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 - Medtronic, Inc. / Medtronic Vascular, Inc. v. Lifeport Sciences LLCNo claims unpatentablePTAB · Apr 21, 2015 · IPR2014-00288 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–5, 7–13, 15, and 16 were not shown unpatentable because the cited references did not establish the claimed permanent curve.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“Considering the teachings of the Specification, we conclude that the curve element must be permanent, as recited in the claims, rather than “resiliently flexible.” The Specification teaches that in some embodiments, the hook or protrusion “is resiliently flexible so as to form a substantially straight profile when compressed,” (Ex. 1001, Abstract) but “may be permanently-deformed into the curved configuration by heat setting the material” (id. at 6:1–4). As emphasized by Lifeport, the Specification teaches that a permanently deformed hook and frame—and, thus, a permanent curve—can be produced by heating Nitinol hook and frame combinations “at 550° for ten minutes.” Resp. 25–26 (citing Ex. 1001, 6:3– 4); see Ex. 2001 ¶ 77. When thus “permanently deformed,” “hook 20 may still be compressed into alignment with the frame 22 without losing the preset curve,” and subsequently “deployed in the curved configuration by releasing.” Ex. 1001, 6:7–9 (emphases added). We further note that the Specification makes clear that the disclosed hooks are incorporated into a variety of devices deployed in the veins of living bodies (see, e.g., Ex. 1001, 3:60–4:8), and subject to various physical forces therein. The ’662 patent, thus, discloses an embodiment having “a plurality of hooks 20 from the same incisions 40,” which “could form hooks 20 which project in opposing directions” and “provide superior resistance to radial and axial loads from the corporeal lumen and blood flow.” Ex. 1001, 5:33–37. In light of the foregoing, we refine our construction of “permanent curve” to be “a preset curve that maintains a fixed arc throughout normal use regardless of what configuration the device is in.” Insofar as Petitioners, and/or Petitioners’ expert, argue that the challenged claims are unpatentable under multiple constructions of this term, we address only those arguments relevant to this construction below.” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Lifeport has the more persuasive position. First, we note that endoprostheses such as those disclosed in the ’662 patent are deployed and function in a living body (see, e.g., Ex. 1001, 3:60–4:8). Accordingly, our construction of permanent curve as a preset curve that maintains a fixed arc throughout normal use regardless of the configuration of the device, is not limited to sheathed and unsheathed configurations taken in isolation. Thus, whereas Dr. Loomis’s analysis of Lefebvre focuses on the force applied by a catheter sheath impinging on a single tooth of the Lefebvre device, “throughout normal use” more broadly encompasses the deployed configuration of Lefebvre Figure 3 in which teeth 6, 7 penetrate into the vein wall “one in the direction of flow of the blood and the other in the opposite direction.” See Ex. 1003, 1:64–66. Dr. Loomis addressed the compressive effects during the application of a catheter sheath. We find no evidence that Dr. Loomis addressed compressive, hemodynamic, or other forces on the Lefebvre teeth when the device is deployed and functioning in normal use.9 9 Although an analysis of the forces applied to the Lefebvre device when it is deployed in a vein is among the issues raised in Medtronic’s Motion to Exclude Evidence, we need not resort to Dr. Loomis’s contested testimony as the omission is self-evident. We also are not persuaded by Medtronic’s assertion that Figure 3 and column 3, lines 34–42, of Lefebvre demonstrate The evidence of record is, therefore, insufficient to demonstrate that Lefebvre maintains a permanent curve as properly construed.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“Lazarus specifically teaches that by modifying hooks like those of Lefebvre to make them sharper, or to configure them as barbs or arrowheads, more secure anchoring of the device can be achieved. . . . Thus, a person of skill in the art dealing with the problem of intraluminal device migration would have been motivated to combine the teaching of Lazarus with that of Lefebvre to achieve even stronger anchoring of the device to the lumen wall. For the reasons discussed above, we find that Lefebvre fails to disclose or suggest the “permanent curve” set forth in independent claims 1 and 10, from which claims 7, 8, and 15 depend. As there is no assertion of record that the missing element is provided in Lazarus, we conclude that Petitioners have not proven by a preponderance of the evidence that the combination of Lefebvre and Lazarus renders claims 7, 8, and 15 unpatentable under 35 U.S.C. § 103(a).” slip op. at 22
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We do not discern, nor does Dr. Loomis adequately explain, how the angular relationship of White’s engagement members, whether in an expanded, flat, or inwardly-projection configuration, comports with our construction of permanent curve. At best, Dr. Loomis identifies changes in the shape of White’s engagement members in response to temperature or compressive forces. On their face, such changes are incompatible with a permanent curve that is a preset curve that maintains a fixed arc throughout normal use regardless of what configuration the device is in. Dr. Loomis has not convinced us of a contrary interpretation of the White reference. Accordingly, we credit Ms. Gold’s testimony that “[n]othing in the disclosure of White indicates that the engagement members 21 have a permanent curve.” Ex. 2001 ¶ 59.” slip op. at 27
Patent outcomesUS 7,147,662 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 7,147,662
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.