- Nuvasive, Inc. v. Warsaw Orthopedic, Inc.All claims unpatentablePTAB · Dec 17, 2014 · IPR2013-00395 · APJ Lora M Green · IPR · Final written decision
Claims 1–6 are unpatentable under § 103(a) over both Senter and Brantigan ’035, and Michelson ’037, Wagner, and Brantigan ’035.
RulingsFinal written decision- Skill levelOther
“A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). The level of ordinary skill in the art usually is evidenced by the references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“As demonstrated by the embodiment shown in Figure 14, reproduced above, however, there may be more than a single bearing surface. The claim language only requires that those bearing surfaces be convex. We agree, therefore, with Petitioner that the claim language does not require that the convexity be along the entire length of the implant. Moreover, independent claims 1 and 4 only require that the “upper and lower bearing surfaces . . . being convex along the entire length of said upper and lower bearing surfaces.” There is nothing in the claim language that requires that the convexity conform to the anatomic endplates of the adjacent vertebrae. The Specification does not provide a definition of convexity as conforming to the anatomic endplates of the adjacent vertebrae with reasonable clarity, deliberateness, and precision. We decline, therefore, to construe the convexity of the bearing surfaces as requiring that the convexity conform to the anatomic endplates of the adjacent vertebrae. Thus, we construe “upper and lower bearing surfaces” as requiring that the bearing surface itself must be convex along the entire length of the bearing surface, but as the implant may have more than one upper bearing surface, as well as more than one lower bearing surface, the convexity need not be along the entire length of the implant. Moreover, the convexity need not conform to the anatomic endplates of the adjacent vertebrae.” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Evidence of commercial success, or other secondary considerations, is only significant if there is a nexus between the claimed invention and the commercial success.” Ormco Corp. v. Align Tech. Inc., 463 F.3d 1299, 1311-12 (Fed. Cir. 2006). “For objective evidence to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). In order to establish a proper nexus, the patent owner must offer proof that the sales were a direct result of the unique characteristics of the claimed invention—as opposed to other economic and commercial factors unrelated to the quality of the patented subject matter. See Microsoft v. Proxyconn, Inc., IPR2012-00026, slip op. at 4 (PTAB Mar. 8, 2013) (Paper 32). Patent Owner, however, has not attempted to establish a nexus between the claims of the ’696 and the CLYDESDALE® Spinal System. Thus, Patent Owner’s arguments and evidence as to commercial success are entitled to little or no weight. slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundMotivation foundDecided for petitioner
“Moreover, as taught by Brantigan ’035, the sharp apexes of the nubs bite into the vertebrae bone, and, thus, once the implant is in the proper position, it will not shift from that position. Ex. 1005, 21:1–5. We, thus, credit Dr. Brantigan’s testimony that the ratchetings would not propel an implant forward, but would resist forward movement of the implant, as well as back-out of the implant, after implantation. Ex. 1017 ¶ 18. Thus, we agree with Petitioner that Senter does not teach away from the combination with Brantigan ’035.” slip op. at 19
Patent outcomesUS 8,444,696 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,444,696 - Nuvasive, Inc. v. Warsaw Orthopedic, Inc.All claims unpatentablePTAB · Dec 17, 2014 · IPR2013-00396 · APJ Lora M Green · IPR · Final written decision
Claims 7–12 are unpatentable under § 103(a) as obvious over the combination of Steffee, Michelson ’037, and Kim.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Patent Owner argues that ratchetings should be construed as “facets that are angled to afford forward movement of the spinal fusion implant in one direction and facets that are angled to prevent the spinal fusion implant from backing out in the opposite direction.” PO Resp. 17 (citing Ex. 2005 ¶ 38). Petitioner does not present an alternate construction. We determine that Patent Owner’s construction is consistent with the Specification and the language of the claim itself, and, thus, we adopt that construction.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“a hole that extends from the upper bearing surface to the lower bearing surface that is of sufficient size to permit growth of bone therethrough. Stated differently, “opening,” as required by challenged independent claims 7 and 10, requires that the hole be vertical in the implant as placed. While Steffee does not teach a vertical opening, it does teach that the implant has a plurality of horizontal openings that extend between the side surfaces to allow for blood flow, as well as bone growth from one side of the implant to the other. Ex. 1108, 2:64–67. Michelson ’037 also teaches an implant that may contain a plurality of cells or openings of 1–3 mm, into which fusion-promoting materials may be placed, allowing a bony bond between the adjacent vertebrae to each other, as well as to the implant. Ex. 1109, 8:10–21. Thus, the openings of Steffee and the opening of Michelson ’037 serve the same purpose—that is, to allow the growth of bone to aid in bonding the implants to the adjacent vertebrae. The addition of vertical openings as taught by Michelson ’037 to the implant of Steffee would have been a predictable use of an element taught by the prior art according to its established function. KSR, 550 U.S. at 417.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“The obviousness inquiry, however, does not require an advantage or an improvement in properties. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (“[A] finding that the prior art as a whole suggests the desirability of a particular combination need not be supported by a finding that the prior art suggests that the combination claimed by the patent applicant is the preferred, or most desirable, combination.”); see also In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (“[a] known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.”). Moreover, the fact that Brantigan ’757, referenced by Steffee, discloses horizontal slots, but Steffee did not adopt them, does not amount to a teaching away from the use of horizontal slots. See Fulton, 391 F.3d at 1201 (“The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any . . . alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.”).” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightDecided for petitioner
“Michelson ’037 and Kim as compared to Steffee, Petitioner engaged in improper hindsight in combining Steffee with Michelson ’037 and Kim to arrive at the implant of challenged independent claims 7 and 10. PO Resp. 46. We disagree. Although the Supreme Court has cautioned that it may be valuable to identify a particular reason to combine two references, the obviousness analysis is not limited to this inquiry. See KSR, 550 U.S. at 418–19. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Similarly, “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. The combination of Steffee, Michelson ’037, and Kim is no more “than the predictable use of prior art elements according to their established functions.” Id.” slip op. at 24
Patent outcomesUS 8,444,696 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,444,696 - 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 · IPR2013-00372 · APJ Scott E Kamholz · IPR · Final written decision
Claims 1–12 and 16–21 were not shown unpatentable over Ashley ’932 and Sheth because Sheth’s secondary loading portion was not a delayed-release portion.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“agree with Amneal that the broadest reasonable construction of “delayed release,” in light of the specification of the ’406 patent, is not limited to formulations requiring that there be no substantial release in the stomach. The portion of the ’406 patent specification upon which Supernus relies to support its narrower construction addresses properties of “enteric coated pellets,” not a delayed-release component. Ex. 1009, 7:56. The ’406 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 ’406 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).” 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 ¶ 176. 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) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“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
Patent outcomesUS 8,394,406 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,394,406 - 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 - Sequenom, Inc. v. The Board Of Trustees Of The Leland Stanford Junior UniversityNo claims unpatentablePTAB · Nov 25, 2014 · IPR2013-00390 · APJ Francisco C Prats · IPR · Final written decision
Claims 1–17 were not shown unpatentable because the Board found they were reduced to practice before Lo II’s filing date, so Lo II was not prior art.
RulingsFinal written decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner
“when it is successfully performed.” Shurie v. Richmond, 699 F.2d 1156, 1159 (Fed. Cir. 1983). “In order to establish an actual reduction to practice, an inventor’s testimony must be corroborated by independent evidence. . . . [A] ‘rule of reason’ analysis is applied to determine whether an inventor’s testimony regarding reduction to practice has been sufficiently corroborated.” Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998) (citation omitted). This “rule of reason” analysis “requires an evaluation of all pertinent evidence when determining the credibility of an inventor’s testimony.” Id. Under that analysis, “to corroborate a reduction to practice, it is not necessary to produce an actual over-the-shoulder observer. Rather, sufficient circumstantial evidence of an independent nature can satisfy the corroboration requirement.” Id. Corroborating evidence may be “testimony of a witness, other than an inventor, to the actual reduction to practice or it may consist of evidence of surrounding facts and circumstances independent of information received from the inventor.” Hahn v. Wong, 892 F.2d 1028, 1032–33 (Fed. Cir. 1989). Corroboration, however, “is not necessary to establish what a physical exhibit before the [B]oard includes. Only the inventor’s testimony requires corroboration before it can be considered.” Price v. Symsek, 988 F.2d 1187, 1195 (Fed. Cir. 1993) (citation omitted).” slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable
“In sum, for the reasons discussed, non-inventor corroborating evidence reasonably supports Patent Owner’s assertion that, on June 19, 2008, inventor Dr. Fan sent to Dr. Blumenfeld the draft of the PNAS paper appearing in Exhibits 2111 and 2113. As also discussed above, the evidence reasonably supports Patent Owner’s assertion that that document describes an actual reduction to practice of the processes recited in claims 1–17 of the ’415 patent. We are persuaded, therefore, that Patent Owner has shown that the subject matter of the challenged claims was reduced to practice before Lo II’s July 23, 2008 filing date. Accordingly, because the evidence does not support Petitioner’s position that Lo II constitutes prior art to the challenged claims under 35 U.S.C. § 102(e), and because Lo II is relied upon in every ground on which trial was instituted, Petitioner has not shown by a preponderance of the evidence that any of the challenged claims is unpatentable, based on any of the asserted grounds of unpatentability. III. CONCLUSION” slip op. at 14
- Expert testimonyPatent owner expert creditedDecided for patent owner
Patent outcomesUS 8,195,415 not shown unpatentable§ 102 anticipationPatents in suitUS 8,195,415 - PTAB · Nov 24, 2014 · PGR2014-00010 · APJ Jon B Tornquist · PGR · Order
The Board granted the parties’ joint motion and terminated PGR2014-00010 without a final decision; it also granted confidential treatment of the settlement agreement.
RulingsOther- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“Patent Owner’s preliminary response is not yet due. On November 20, 2014, the parties filed a joint motion to terminate the proceeding (Paper 7) and a copy of their written settlement agreement (Ex. 2001). Along with the motion to terminate, the parties also filed a joint motion to treat the settlement agreement as business confidential information and keep it separate from the file of U.S. Patent No. 8,598,219 (“the ’219 patent”) pursuant to 35 U.S.C. § 327(b) and 37 C.F.R § 42.74(c). Paper 8, 1.” slip op. at 2
NonePatents in suitUS 8,598,219 - Ariosa Diagnostics v. The Board Of Trustees Of The Leland Stanford Junior UniversityAll claims unpatentablePTAB · Nov 19, 2014 · IPR2013-00308 · APJ Lora M Green · IPR · Final written decision
Claims 1–13 are unpatentable: claims 1–5, 7–9, 12, and 13 as anticipated by Lo; claims 10–11 and 6 as obvious over Lo with Brenner and Li, respectively.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“recites (emphasis added) “sequencing predefined subsequences of the maternal and fetal DNA to obtain a plurality of sequence tags aligning to the predefined subsequences.” Thus, the claim language associates “sequencing predefined sequences” with obtaining “sequence tags.” The Specification of the ’076 patent discusses sequence tags in the context of shotgun sequencing. See, e.g., Ex. 1001, col. 14, ll. 56–66. As Petitioner notes, there is no discussion in the Specification of the term “targeted sequencing.” Reply 1. Instead, the ’076 patent also discloses the use of a large number of windows of defined length created along the chromosome, such that the windows cover each chromosome in question, except for the non-informative regions of the chromosome, such as centromere and repetitive regions, may be omitted. Id. at col. 4, ll. 56–62. Thus, “[v]arious average numbers, i.e., median values, are calculated for different windows and compared. By counting sequence tags within a series of predefined windows of equal lengths along different chromosomes, more robust and statistically significant results may be obtained.” Id. at col. 4, ll. 62–67 (emphasis added). As taught by the ’076 patent, “[e]ach autosome (chr. 1–22) is computationally segmented into contiguous, non-overlapping windows,” although sliding windows could also be used. Id. at col. 5, ll. 4–9. In addition, as noted above, the ’076 patent also provides examples that describe “direct sequencing of cell-free DNA from plasma of pregnant women with high throughput shotgun sequencing technology,” wherein sequences were mapped to specific chromosomal regions, allowing for the measurement of over- and under-representation of chromosomes from an aneuploid fetus. Id. at col. 20, ll. 30–36. Thus, the Specification does not disclose sequencing only the defined sequences as Patent Owner would have us construe this phrase, but instead, it discloses sequencing the predefined sequences along with other sequences, and then using various techniques to locate the predefined sequences in the material that has been sequenced. Thus, we conclude that the broadest reasonable interpretation of the phrase “sequencing predefined subsequences” is that the subsequences may be predefined through comparison with the predefined windows that are created along the length of the chromosome. The predefined subsequences may walk along the entire length of the chromosome. Thus, although one predefined subsequence would not include the entire chromosomal sequence, two or more subsequences may include the entire length of the chromosomal sequence. That interpretation encompasses the preferred embodiment of the ’076 patent, whereas Patent Owner’s proffered construction limiting the method of claim 1 to “targeted” sequencing, as Patent Owner defines that term, would not” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“may then be sequenced, for example, by using massively parallel sequencing methods. Id. ¶¶ 55–56. As taught by Lo, sequence tags are generated, aligned to each chromosome, and tags identified as originating from a potentially aneuploid chromosome are compared quantitatively to tags originating from a reference chromosome, to allow for the identification of chromosomal gains or losses. Id. ¶ 70. That falls within the scope of the limitation of step (b) of claim 1 of “sequencing predefined subsequences of the maternal and fetal DNA to obtain a plurality of sequence tags aligning to the predefined subsequences, wherein said sequence tags are of sufficient length to be assigned to a specific predefined subsequence.” That is, as construed above, the sequencing step is not limited to sequencing only the predefined subsequences, but encompasses sequencing other portions of the genome. And, as Lo teaches that the sequence tags are aligned to a chromosome to allow for the identification of chromosomal gains or losses (id. ¶ 70), the tags generated must necessarily be of sufficient length to be assigned to a specific predefined subsequence. See, e.g., Ex. 1008 ¶ 60 (noting that although Lo “does not describe specifically that the sequence tags were of sufficient length to be assigned to a specific region of the genome, one skilled in the art would understand this to be the case, because the sequence tags used to identify chromosomal origin must have been of sufficient length to allow assignment to a particular genomic region”).” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“us, Petitioner has not demonstrated that the ordinary artisan would have combined Quake and Kapur as set forth in the Petition (29–39) to arrive at the method of challenged claim 1. In particular, Petitioner relies on Figures 6 and 7 of Kapur as teaching “a method for sequence determination of randomly generated DNA fragments using arrays having oligonucleotides of known sequence. Sequencing of a randomly generated genomic fragment via binding to a predefined sequence on an array aligns a random sequence to a probe indicative of a specific genomic region.” Pet. 31. The evidence relied upon by Petitioner does not explain, however, why one would have a used a method for detecting SNPs as taught by Kapur to perform the sequencing of Quake. That is, what is lacking in the Petition and accompanying Declarations is an “articulated reason[] with some rational underpinning to support the legal conclusion of obviousness.” Kahn, 441 F.3d at 988. Petitioner responds that the “sequencing by array technology of Balasubramanian (US 2003/0022207 A1, published Jan. 30, 2003, Ex. 1040) is cited in all of Kapur (Ex. 1005 ¶ 163), Quake (Ex. 1006 ¶ 120), and the ‘076 patent (Ex. 1001 at col. 10, lines 50–56).” Paper 34 ¶ 19. Figures 6 and 7 relied upon by Petitioner, however, are drawn to methods of detecting SNPs, and not to the sequencing array technology of Balasubramanian. In fact, Petitioner first relies on paragraph 163 of Kapur, which it contends cites the sequencing array technology of Balasubramanian, in its challenge of claim 3, which is drawn to the use of massively parallel sequencing. Petitioner cannot rely upon Balasubramanian in its Reply to make up for the deficiencies in its Petition. See, e.g., 37 C.F.R. § 42.23(b) (noting that “[a]ll arguments for the relief requested in a motion must be made in the motion,” and that a “reply may only respond to arguments raised in the corresponding opposition or patent owner response”).” slip op. at 32
- ExcludeMotion to exclude, deniedDenied
“Patent Owner’s objections go more to the weight that paragraph 15 of Exhibit 1043 should be afforded, rather than to its admissibility. It is within our discretion to assign the appropriate weight to be accorded to Dr. Morton’s testimonial evidence. 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, 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.”). We thus decline to exclude paragraph 15 of Exhibit 1043.” slip op. at 36
Patent outcomesUS 8,296,076 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,296,076 - PTAB · Nov 18, 2014 · IPR2014-00116 · APJ Jacqueline Wright Bonilla · IPR · Order
The Board granted the parties’ joint motion to terminate the proceeding following settlement.
RulingsOther- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“On November 14, 2014, pursuant to 35 U.S.C. § 317(a), the parties filed a Joint Motion to terminate this proceeding. Paper 30. Accompanying the Motion, the parties filed a true copy of a settlement agreement along with a Joint Request to treat the settlement agreement as business confidential, to be kept separate from the patent file under 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74. Ex. 2017; Paper 31. We authorized the filing of these papers during a conference call conducted November 12, 2014. Paper 29.” slip op. at 2
NonePatents in suitUS 8,288,745 - Symantec Corporation v. Rpost Communications LimitedAdverse judgmentPTAB · Nov 7, 2014 · IPR2014-00357 · APJ Thomas L Giannetti · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner after it cancelled claims 9–20, the only claims instituted for review.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“DISCUSSION A party may request entry of adverse judgment against itself at any time during a proceeding. 37 C.F.R. § 42.73(b). Here, Patent Owner has cancelled each claim for which inter partes review has been instituted, and thus Patent Owner has no remaining claim in the trial. Id. § 42.73(b)(2). Under these circumstances, the entry of judgment adverse to the Patent Owner and cancellation of the claims as requested is appropriate.” slip op. at 2
NonePatents in suitUS 8,468,199
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.