• Greene’S Energy Group, LLC v. Oil States Energy Services, LLCNo claims unpatentable
  PTAB · May 1, 2015 · IPR2014-00364 · APJ William A Capp · IPR · Final written decision

  The Board found claims 1–13, 27, and 30–32 not shown unpatentable because the proposed obviousness combinations did not establish the claimed mechanical lockdown mechanism and its required function.

  RulingsFinal written decision

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

    “The parties do not dispute that a “lockdown mechanism” maintains the mandrel in a fixed position during a fracking or well treatment operation. Thus, we will construe “lockdown mechanism” to mean “machinery for maintaining [the mandrel] in a fixed position during a fracking or well treatment operation.” This leaves us to determine what it means for a lockdown mechanism to be “mechanical” and whether the correct construction requires imposing a further definitional limitation regarding a range of adjustment. Oil States points out that the Specification differentiates a mechanical mechanism from hydraulic mechanisms. PO Resp. 12. The Specification distinguishes the instant invention from an earlier invention by the same inventor that discloses a hydraulic unit. Ex. 1001, 2:28–63. The Specification further states that: a mechanical lockdown mechanism for securing the BOP protector mandrel in an operative position is considered more reliable because a source of pressurized hydraulic fluid is not required. Id. at 2:3–6; see also id. at 3:53–56. Greene does not challenge that this language in the Specification effectively differentiates a mechanical lockdown mechanism from a hydraulic mechanism. Thus, we construe “mechanical” lockdown mechanisms as being limited to purely mechanical means such as nuts and bolts and the like. We further clarify that the principal holding force that maintains the mandrel in a fixed position is not a dynamic force such as through hydraulic, pneumatic, or electrical means or the like.” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “Oil States’s effort to read a “broad range of adjustment” limitation into the definition of mechanical lockdown mechanism in claim 1 renders the dependent limitation in claim 3 superfluous. Claim 2 claims an elongated spiral thread. There is no need to add a further limitation to claim 3 to provide for adjustment to compensate for variations in the distance between a top of the blowout preventer and the top of the casing of different wellheads if a “broad range of adjustment” is already contemplated in the meaning of mechanical lockdown mechanism. 8 It is well-settled that each claim does not necessarily cover every feature disclosed in the specification. See Ventana Med. Sys., Inc. v. Biogenex Labs, Inc., 473 F.3d 1173, 1181 (Fed. Cir. 2006). When a claim addresses only some of the features disclosed in the specification, it is improper to limit the claim to other unclaimed features. Id. Here, Oil States’s inclusion of adjustment limitations in claims 2 and 3 belie an intention to limit the scope of the term “mechanical lockdown mechanism” in claim 1 to mechanisms that provide a broad range of adjustment.9 Thus, we decline to adopt Oil States’s proposed construction. We construe a “lockdown mechanism” to mean “machinery for maintaining [the mandrel] in a fixed position.” In the context of lockdown mechanisms, we construe the adjective “mechanical” to mean that the lockdown mechanism is limited to purely mechanical means such as nuts and bolts and the like so that the principal holding force that maintains the mandrel in a fixed position 8 In the Summary of the Invention section of the Specification, the topic sentence of the paragraph describing an embodiment with a “significant range of adjustment,” qualifies the description of such embodiment with the word “preferably.” Ex. 1001, 3:8–27. This suggests that this passage of the Specification merely describes one embodiment and not the entire invention. 9 To the extent that claim 1 requires the mechanical lockdown mechanism to have any range of adjustment, such adjustment requirement may be found in the claim limitation directed to the lockdown mechanism being “adapted to ensure that the annular sealing body is securely seated against the top of the casing when the mandrel is in the operative position” and not in definition of “mechanical lockdown mechanism” per se.” slip op. at 11

  • Skill levelSkill level board ownOther

    “Green’s expert, Mr. Shackelford, opines that the person of ordinary skill in the art at the time of the invention of the ’993 patent would have had a Bachelor-level degree in a recognized engineering discipline and practical job exposure of several years with oil and gas well operations. Ex. 1002 ¶ 13. Mr. Shackelford’s testimony is entirely conclusory with no supporting factual analysis. Oil States contends that the level of ordinary skill in the art is “relatively low,” but does not articulate or explain what it means by this characterization. PO Resp. 22. Oil States’s expert, Dr. Wooley, merely adopts Mr. Shackelford’s position and, like Mr. Shackelford, fails to provide any supporting factual analysis. Merely reciting a college degree and a number of years of experience provides little guidance as to the actual capabilities of a person of ordinary skill in the art. Neither party presents a detailed evidentiary showing under the factors recited in Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–97 (Fed. Cir. 1983). 13” slip op. at 22

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

    “combine references is a question of fact. In re Constr. Equip. Co., 665 F.3d 1254, 1255 (Fed. Cir. 2011). Greene fails to persuade us that a person of ordinary skill in the art would have had reason to combine Herricks and McLeod to achieve the invention claimed in claims 1 and 27 of the ’993 patent. Because the mechanical lockdown mechanism in McLeod is intended to be used with a mandrel that packs off at an indeterminate point in the casing, rather than at a fixed point and, therefore, does not disclose any range of adjustment to accommodate production trees of varying heights as would be necessary to be operable in systems designed for fixed point packoff, the proposed combination does not provide a mechanical lockdown mechanism that is adapted to securely seat a mandrel against the top of the casing as required by claim 1. Similarly, the proposed combination does not provide a method for engaging the mechanical lockdown mechanisms to lock the mandrel in the operative position such that the annular sealing body is in fluid sealing engagement with a top of a casing of the well as required by claim 27.” slip op. at 30

  Patent outcomesUS 6,289,993 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,289,993
• Medtronic, Inc. / Medtronic Vascular, Inc. v. Lifeport Sciences LLCNo claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 7,147,662
• Medtronic, Inc. v. Nuvasive, Inc.All claims unpatentable
  PTAB · Apr 3, 2015 · IPR2014-00075 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1, 2, 4, 5, 10, 15, 17, and 18 are unpatentable as obvious over Branch, Obenchain, Blewett, and Koros ’493.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner

    “allow safe and reproducible avoidance of nerves along a lateral trans-psoas path in a fashion that avoids the bony posterior elements of the spinal column. Ex. 1018, 11:51–54. Claim 1, however, does not require the “trans-psoas path” to pass through any particular portion of the psoas muscle, nor does the claim require any particular degree or extent of passage through the psoas. Moreover, the ’767 patent does not expressly define “trans-psoas path.” See also Tr. 39:12–40:1, 113:5–114:3 (conceding that the claims are not limited to any particular approach through the psoas muscle). Accordingly, we conclude that the broadest reasonable construction, consistent with the ’767 patent specification, of “trans-psoas path,” encompasses a path which passes through any portion of the psoas muscle, regardless of the degree or extent of the passage.” slip op. at 9

  • Skill levelOther

    “As to the level of ordinary skill in the pertinent art, the parties, as discussed below, challenge their opposing experts’ conclusions and qualifications. Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In that regard, the parties’ experts advance slightly different opinions as to the level of ordinary skill in the pertinent art. See Ex. 1016 ¶ 11 (Watkins Decl.)); Ex. 2020 ¶ 17 (Phillips Decl.). Both experts, nonetheless, agree generally that an ordinarily skilled artisan at the critical time would have been an experienced spinal surgeon, or an experienced engineer or professional involved in the implementation or design of surgical instruments for use in spinal surgery, with significant access to orthopedic or neurosurgeons. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We note also that the level of ordinary skill in the art may be evidenced by the cited references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “Given Blewett’s teachings, Petitioner persuades us that an ordinarily skilled artisan, creating initial access into a patient for spinal surgery, using guidewires and a plurality of dilators as taught by Branch, would have been prompted to equip the initial dilator with a nerve monitoring electrode, as required by claim 1 of the ’767 patent, to allow the surgeon to avoid nerves. Petitioner persuades us also that an ordinarily skilled artisan would have been prompted to equip Branch’s retractor blades with a fixation element, as claim 1 requires. Specifically, Koros ’493 discloses that, in a system for providing spinal access similar to that described by Branch, providing two fixation screws that extend distally from the retractor blades, is “advantageous to provide stability and improve support for the distractor system.” Ex. 1006, 6:57–58.” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “A reference does not teach away . . . if it merely expresses a general preference for an alternative invention but does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). In the instant case, as noted above, the Obenchain reference teaches expressly the suitability of a lateral, psoas-traversing pathway when performing minimally invasive surgery on the lumbar spine. Ex. 1003, 6:22–31 (“If desired, the surgery may traverse through the psoas muscle. . . . [F]or example, where the patient has extensive abdominal adhesions, it may be preferred to use a lateral puncture of the abdomen to avoid bowel perforation, and entry into the disc space is lateral, transversing the psoas muscle . . . .”) (emphasis added). Given this express teaching, Petitioner persuades us (Reply 2, 13–14) that the Obenchain reference does not teach away from the lateral trans-psoas pathway required by claim 1 of the ’767 patent. slip op. at 16

  Patent outcomesUS 8,016,767 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,016,767
• Medtronic, Inc. v. Nuvasive, Inc.All claims unpatentable
  PTAB · Apr 3, 2015 · IPR2014-00073 · APJ Francisco C Prats · IPR · Final written decision

  Claims 21, 22, 24, 30, and 33–37 are unpatentable under four § 103 grounds; the two grounds relying on Branch and Blewett fail because Blewett is not prior art.

  RulingsFinal written decision

  • BurdenDecided for petitioner

    “We conclude that Petitioner has proved by a preponderance of the evidence that claims 21, 22, 24, 30, and 33–37 of the ʼ356 patent are unpatentable, based on some, but not all, of the grounds upon which trial was instituted.” slip op. at 4

  • Skill levelOther

    “As to the level of ordinary skill in the pertinent art, the parties, as discussed below, challenge their opposing experts’ conclusions and qualifications. Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In that regard, the parties’ experts advance slightly different opinions as to the level of ordinary skill in the pertinent art. See Ex. 1015 ¶ 11 (Watkins Decl.)); Ex. 2020 ¶ 17 (Phillips Decl.). Both experts, nonetheless, generally agree that an ordinarily skilled artisan at the critical time would have been either an experienced spinal surgeon, or an experienced engineer or professional involved in the implementation or design of surgical instruments for use in spinal surgery, with significant access to orthopedic or neurosurgeons. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We note also that the level of ordinary skill in the art may be evidenced by the cited references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 14

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedOther

    “Having reviewed the ’214 application, including the cited figures, in light of Patent Owner’s contentions and Dr. Phillips’s testimony, we find that the evidence supports Patent Owner’s assertion that an ordinarily skilled artisan would have understood that the ’214 application described a system for accessing a spinal disc of a lumbar spine, the system including a blade holder apparatus configured to releasably lock with a plurality of retractor blades, as claim 21 of the ’356 patent requires. Because that element is the sole feature of claim 21 urged by Petitioner as being absent from the ’214 application, we find also that the evidence does not support Petitioner’s assertion that claim 21 of the ’356 patent is not entitled to the benefit of the ’214 application’s filing date. Petitioner’s arguments do not persuade us to the contrary. It might be true, as Petitioner argues (Reply 15 (citing Ex. 1024 ¶¶ 29–30 (Watkins Reply Decl.))), that the cited figures of the ’214 application do not depict a hexagonal shape or threading that would have indicated the locking elements were nuts or bolts. Petitioner does not adequately explain, however, why the absence of such depictions demonstrates that Dr. Phillips erroneously characterized those elements. As to Dr. Phillips’s testimony on cross examination that he did not see a nut in Figure 28 of the ’214 application (Reply 15 (citing Ex. 1038, 206:9–207:9 (Phillips Deposition)), we note that on redirect examination he stated that he actually did see a nut-and-bolt structure in Figure 28A. Ex. 1038, 208. Moreover, the fact that Dr. Phillips might have misinterpreted one structure in one figure does not persuade us that he erroneously characterized the overall disclosure of the ’214 application, including the several other figures which he referred to in his testimony.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “A. Claim Construction The Board interprets claims using the “broadest reasonable construction in light of the specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, No. 2014-1301, 2015 WL 448667, at *5–*7 (Fed. Cir. Feb. 4, 2015). Under that standard, claim terms are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure. See In re Translogic Tech. Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). In the Decision to Institute we concluded that the recitations in claim 21 regarding the “lateral trans-psoas path to the lumbar spine” relate to an intended use of the claimed apparatus. Dec. 8. Accordingly, we attributed to those intended use recitations no particular structural limitations, beyond an ability to be used in, or follow, a trans-psoas path in the manner recited in the claim. Id. Neither party disputes that claim construction and we maintain it in light of the record developed during trial. No other terms require express construction for purposes of this Decision.” slip op. at 7

  Patent outcomesUS 8,192,356 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,192,356
• Intelligent Bio-Systems, Inc. v. Illumina Cambridge LtdNo claims unpatentable
  PTAB · Feb 11, 2015 · IPR2013-00517 · APJ Francisco C Prats · IPR · Final written decision

  Claims 1–6 and 8 were not shown unpatentable because the evidence did not establish that a skilled artisan would have expected Zavgorodny’s azidomethyl protecting group to work in the sequencing methods of Tsien or Ju.

  RulingsFinal written decision

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

    “In the Decision to Institute, we construed claim 1 as encompassing the use of any protecting group attached via the 2´ or 3´ oxygen atom of a ribose or deoxyribose moiety, in which the protecting group can be modified or removed to expose a 3´ OH group. Dec. 6–7. In doing so, we clarified that, under the broadest reasonable construction standard, claim 1 does not require removal of the protecting group to allow subsequent nucleotide incorporation. Id. The parties do not dispute that claim construction and we see no reason to modify it in light of the record developed during trial. B. Obviousness of Claims 1–6 and 8 over Tsien and Zavgorodny” slip op. at 6

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “As Patent Owner points out, however, Tsien’s second set of criteria for removal of the 3´ hydroxyl protecting group includes “quantitative deblocking,” in addition to mild conditions. Ex. 1008, 20:34; PO Resp. 24. As Patent Owner contends (PO Resp. 30), the Petition does not point to any specific evidence explaining why an ordinary artisan would have expected Zavgorodny’s azidomethyl protecting group to meet that requirement (see Pet. 31–40), despite acknowledging the “quantitative deblocking” requirement of Tsien’s methods (id. at 37). As Patent Owner contends (PO Resp. 24), Petitioner’s expert, Dr. Branchaud, testified that quantitative deblocking would have been understood to mean essentially 100% removal of the protecting group: Q. And could you explain to me what does it mean that the use of a three prime blocking group must include criteria 2 that would be availability of mild conditions for rapid and quantitative deblocking? . . . A. Well, again, I think that’s an operational definition. It’s just saying that in order for the process to happen effectively or efficiently, that deblocking step has to be rapid and -- and efficient. Q. Is efficient analogous to quantitative? A. Not necessarily. I think it could be. Rapid means it goes fast. Quantitative means it goes in high, essentially hundred percent yield. Ex. 2039, 97–98 (Branchaud Deposition, emphasis added). In contrast, as Patent Owner points out, Loubinoux discloses that removal of an azidomethyl protecting group from a phenolic hydroxyl using triphenylphosphine, followed by water in tetrahydrofuran at 25 °C, resulted in deprotected phenols “as pure products at a yield between 60 and 80%.” Ex. 1006, 5; PO Resp. 24.” slip op. at 12

  • Strike new argumentNew argument disregardedDecided for patent owner

    “that Petitioner’s Reply exceeds the proper scope of a reply. As provided in 37 C.F.R. § 42.23(b), a “reply may only respond to arguments raised in the corresponding opposition or patent owner response.” Thus, “a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned. The Board will not attempt to sort proper from improper portions of the reply.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012). One indication that a new issue has been raised in a reply is where a petitioner submits “new evidence necessary to make out a prima facie case” of unpatentability of an original claim. Id. As noted above, in urging obviousness based on Tsien and Zavgorodny, the Petition relies expressly on the fact that “Zavgorodny teaches the desired property [in Tsien] that the azidomethyl group ‘can be removed under very specific and mild conditions.’” Pet. 38–39 (quoting Ex. 1004, 7595 (Zavgorodny)). The Reply, presented with evidence that an ordinary artisan would not have considered Zavgorodny’s conditions suitably mild for Tsien’s sequencing purposes, offers a distinct new line of reasoning—that an ordinary artisan would have considered it obvious to use deprotecting conditions other than those described in Zavgorodny: [Patent Owner]’s argument is based on the faulty assumption that a POSITA would be limited to the specific removal conditions discussed in Zavgorodny. . . . A POSITA would use ordinary creativity to modify the removal conditions suggested by Zavgorodny to meet the requirements of Ju and Tsien, if needed. Reply 4–5 (quotations removed, citations omitted, emphasis added). Thus, the Reply presents new issues by changing the unpatentability rationale from express reliance on Zavgorodny’s deprotecting conditions, to asserting that those conditions would have been obvious to modify, as well as presenting new evidence to support the new rationale and explain the modifications to Zavgorodny. See id. at 5–6 (citing Ex. 1031 (Branchaud Reply Decl.)). Moreover, despite having acknowledged the quantitative deblocking requirement in Tsien (Pet. 37), the Reply does not indicate where, in the Petition, Petitioner explained specifically why an ordinary artisan would have expected Zavgorodny’s azidomethyl moiety to meet Tsien’s quantitative deblocking requirement for the 3´ hydroxyl protecting group. On that issue, the Reply advances, instead, a number of arguments which were not presented previously, as well as Dr. Branchaud’s Reply Declaration. Reply 7–8 (citing Ex. 1031). In his Reply Declaration, Dr. Branchaud, in turn, expands on the assertions in the Reply by presenting a number of additional new arguments explaining why quantitative deblocking would have been expected, and cites a number of non-patent literature references which were not relied upon to support unpatentability in the Petition. See Ex. 1031 ¶¶ 19–26. Because the Petition did not address Tsien’s quantitative deblocking requirement, and because the Reply proffers argument and evidence not presented previously on that issue, the Reply presents new issues, rather than merely rebutting the Patent Owner Response. In addition, in asserting that quantitative deblocking would have been expected using Zavgorodny’s conditions, the Reply relies extensively on indepth explanations and supporting documentary evidence presented in Dr. Branchaud’s Reply Declaration. The Reply does not explain, however, the basis of its arguments with nearly the same degree of specificity as that presented in Dr. Branchaud’s Reply Declaration, nor does the Reply cite any of the exhibits advanced in Dr. Branchaud’s Declaration. See Reply 7–8. For example the Reply states that, “[f]or SBS, a POSITA would use a much higher concentration of cleavage reagent to drive the reaction rapidly to completion.” Id. at 8 (citing Ex 1031 ¶¶ 25–26). None of the extensive reasoning or analysis or evidence cited in paragraphs 25 and 26 of the Branchaud Reply Declaration appears in the Reply, however. Accordingly, the Reply also does not comply with 37 C.F.R. § 42.6(a)(3), which states that “[a]rguments must not be incorporated by reference from one document into another document.”” slip op. at 14

  • ExcludeMotion to exclude, deniedOther

    “2045, 2050, 2055, 2057, 2059, 2062, 2075, 2076, 2087, 2089 (Burgess Decl.), and 2139–2152, as well as Exhibits 2058, 2060, and 2091–2121, cited in the Burgess Declaration. Pet. Mot. to Exclude 1. Because our decision does not rely on any of the challenged exhibits, we dismiss Petitioner’s Motion to Exclude Evidence as moot.” slip op. at 22

  Patent outcomesUS 7,566,537 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 7,566,537
• Cyanotech Corporation v. The Board Of Trustees Of The University Of IllinoisSome claims unpatentable
  PTAB · Dec 12, 2014 · IPR2013-00404 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–14 and 26 are unpatentable over Grangaud and/or Grangaud with Dowling; claims 15, 21, and 22 were not shown unpatentable.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

    “treating damage caused by injury or disease (Resp. 14–15), however, the specification does not contain any indication that the patentee intended to act as his own lexicographer clearly defining “disease” and “damage” in the same manner. For example, the specification does not clearly convey the patentee’s intent to appoint a special meaning to the phrase “retinal damage or retinal disease.” We must determine, therefore, the ordinary meaning of “disease” and “damage” as used in these claims to one of skill in the art in light of the specification and prosecution history. In re Paulsen, 30 F.3d at 1480. In this regard, the term “damage,” as used in the specification, refers to damage resulting from injury or disease. Ex. 1001, 1:14–19. The specification does not equate damage and disease, but provides that damage may be caused by disease. Id. The meaning of the term disease, however, refers to conditions that may cause damage (such as degenerative eye disease), and are treatable themselves. Id. at 15:36–40. That is, the underlying cause of the damage is treatable, not just the damage alone. The University does not direct our attention to anything in the specification or prosecution that would clearly alter the ordinary meaning of “disease” and “damage.” Resp. 14–16. In view of the above, we do not construe “retinal damage” and “retinal disease” as a single concept. The evidence of record does not support a finding that the patentee acted as his own lexicographer by clearly defining the claim terms “damage” and “disease” in the same manner. In our Decision to Institute, we adopted the dictionary definition of “disease” and construed the term as “[a] morbid entity ordinarily characterized by two or more of the following criteria: recognized etiologic agent(s), identifiable group of signs and symptoms, or consistent anatomic alterations.” Dec. 8–9; see, Pet. ’401 (citing Ex. 1040). We adopted the dictionary definition of “damage” and construed the term as “[h]arm, diminution, or destruction of an organ, body part, system, or function.” Id. We maintain these constructions for “disease” and “damage” as they are consistent with the use of these terms in the Specification. “Retinal damage” refers to damage to the retina and “retinal disease” refers to disease of the retina. The phrase “retinal damage or retinal disease” refers to either retinal damage or retinal disease.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureUnpatentableNot shown unpatentableMixed

    “To establish inherent disclosure, the evidence must show that a feature necessarily is described in the reference, and that it would be recognized by persons of ordinary skill. In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999); cf. EMI Grp. N. Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342, 1351 (Fed. Cir. 2001) (“Theoretical mechanisms or rules of natural law that are recited in a claim, that themselves are not patentable, however, do not need to be recognized by one of ordinary skill in the art for a finding of inherency.”). The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency. In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993). Inherency may not be established by probabilities or possibilities. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981).” slip op. at 10

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “As to secondary considerations, we note that factual inquiries for an obviousness determination include secondary considerations based on evaluation and crediting of objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). Notwithstanding what the teachings of the prior art would have suggested to one with ordinary skill in the art at the time of the University’s invention, the totality of the evidence submitted, including objective evidence of nonobviousness, may lead to a conclusion that the claimed invention would not have been obvious to one with ordinary skill in the art. In re Piasecki, 745 F.2d 1468, 1471-1472 (Fed. Cir. 1984). However, such a conclusion requires the finding of a nexus to establish that the evidence relied upon traces its basis to a novel element in the claim and not to something in the prior art. Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). All types of objective evidence of nonobviousness must be shown to have nexus. In re GPAC Inc., 57 F.3d at 1580 (nexus generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial success); In re Antor Media Corp., 689 F.3d 1282, 1293 (Fed. Cir. 2012) (licensing); Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (copying); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need); and In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (unexpected results). As discussed above, we conclude that claims 1, 3, and 8–12 are anticipated by Grangaud, as evidenced by Dowling. Because anticipation is the epitome of obviousness, a disclosure that anticipates under 35 U.S.C. § 102 also renders the claim unpatentable under 35 U.S.C. § 103. See In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982) (“[E]vidence establishing lack of all novelty in the claimed invention necessarily evidences obviousness.”); In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Here, Cyanotech presents substantially the same evidence for both their anticipation and obviousness challenges of claims 1, 3, 8–14, and 26. As such, and for the same reasons set forth in our anticipation analysis above, we hold that claims 1, 3, 8–14, and 26 are rendered obvious by Grangaud, alone or in combination with Dowling. Because we have determined that claims 1, 3, and 8–12 lack a novel feature with which to establish a nexus with secondary considerations, Cyanotech, as a matter of law, cannot establish a nexus. In re Kao, 639 F.3d at 1068 (Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention.). As to claims 2 and 4–7, the University has not directed any arguments to these claims specifically and has not made any attempts to establish a nexus between the presented objective evidence of nonobviousness and these claims. Thus, we maintain our unopposed determination that the specific doses and routes of administration recited in these claims are predictable variations within the technical grasp of a person of ordinary skill in the art, and are not persuaded by the objective evidence that claims 2 and 4–7 are nonobvious.” slip op. at 23

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “of all novelty in the claimed invention necessarily evidences obviousness.”); In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Here, Cyanotech presents substantially the same evidence for both their anticipation and obviousness challenges of claims 1, 3, 8–14, and 26. As such, and for the same reasons set forth in our anticipation analysis above, we hold that claims 1, 3, 8–14, and 26 are rendered obvious by Grangaud, alone or in combination with Dowling. Because we have determined that claims 1, 3, and 8–12 lack a novel feature with which to establish a nexus with secondary considerations, Cyanotech, as a matter of law, cannot establish a nexus. In re Kao, 639 F.3d at 1068 (Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention.). As to claims 2 and 4–7, the University has not directed any arguments to these claims specifically and has not made any attempts to establish a nexus between the presented objective evidence of nonobviousness and these claims. Thus, we maintain our unopposed determination that the specific doses and routes of administration recited in these claims are predictable variations within the technical grasp of a person of ordinary skill in the art, and are not persuaded by the objective evidence that claims 2 and 4–7 are nonobvious. In view of the above, we conclude that Cyanotech has demonstrated the unpatentability of claims 1–14 and 26 by a preponderance of the evidence. (2) Claim 15 Claim 15 depends from claim 14. As discussed above, we conclude that the preponderance of evidence of record demonstrates that neuronal damage to a retina is inherent to the condition of vitamin A deficiency-induced xerophthalmia. The question before us with regard to claim 15, however, is whether” slip op. at 24

  Patent outcomesUS 5,527,533 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 5,527,533
• Cyanotech Corporation v. The Board Of Trustees Of The University Of IllinoisSome claims unpatentable
  PTAB · Dec 12, 2014 · IPR2013-00401 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–14 and 26 are unpatentable as anticipated by Grangaud and obvious over Grangaud alone or with Dowling; claims 15, 21, and 22 were not shown unpatentable.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

    “treating damage caused by injury or disease (Resp. 14–15), however, the specification does not contain any indication that the patentee intended to act as his own lexicographer clearly defining “disease” and “damage” in the same manner. For example, the specification does not clearly convey the patentee’s intent to appoint a special meaning to the phrase “retinal damage or retinal disease.” We must determine, therefore, the ordinary meaning of “disease” and “damage” as used in these claims to one of skill in the art in light of the specification and prosecution history. In re Paulsen, 30 F.3d at 1480. In this regard, the term “damage,” as used in the specification, refers to damage resulting from injury or disease. Ex. 1001, 1:14–19. The specification does not equate damage and disease, but provides that damage may be caused by disease. Id. The meaning of the term disease, however, refers to conditions that may cause damage (such as degenerative eye disease), and are treatable themselves. Id. at 15:36–40. That is, the underlying cause of the damage is treatable, not just the damage alone. The University does not direct our attention to anything in the specification or prosecution that would clearly alter the ordinary meaning of “disease” and “damage.” Resp. 14–16. In view of the above, we do not construe “retinal damage” and “retinal disease” as a single concept. The evidence of record does not support a finding that the patentee acted as his own lexicographer by clearly defining the claim terms “damage” and “disease” in the same manner. In our Decision to Institute, we adopted the dictionary definition of “disease” and construed the term as “[a] morbid entity ordinarily characterized by two or more of the following criteria: recognized etiologic agent(s), identifiable group of signs and symptoms, or consistent anatomic alterations.” Dec. 8–9; see, Pet. ’401 (citing Ex. 1040). We adopted the dictionary definition of “damage” and construed the term as “[h]arm, diminution, or destruction of an organ, body part, system, or function.” Id. We maintain these constructions for “disease” and “damage” as they are consistent with the use of these terms in the Specification. “Retinal damage” refers to damage to the retina and “retinal disease” refers to disease of the retina. The phrase “retinal damage or retinal disease” refers to either retinal damage or retinal disease.” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “In view of the above, we conclude that the preponderance of the evidence presented by Cyanotech demonstrates that retinal damage is inherent to the condition of vitamin A deficiency-induced xerophthalmia. Grangaud’s animals were kept on a vitamin A-deficient diet for about 2 months (Ex. 1002, 43), and Dowling supports a conclusion that animals kept on such a diet would have suffered retinal damage. Ex. 1026, 88–89. Dowling also supports a finding that restoration of vitamin A to the diet could reverse the damage caused by a vitamin A deficiency. Id. at 94–96. Grangaud did not administer vitamin A itself, but rather administered astaxanthin. Astaxanthin, however, is capable of being converted to vitamin A in rats, which then would be available to correct the retinal damage caused by a vitamin A-deficient diet, as well as treat ocular lesions resulting from xerophthalmia, thereby improving the vision of the rats. Pet., 14-16; Ex. 1002, 44; Ex. 1033 ¶¶ 42–43 and 51; Ex. 1045, 60 and 160. As such, the inherent action of astaxanthin would have resulted in improved vision in Grangaud’s animal model.” slip op. at 13

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInherency not foundMixed

    “In view of the above, we conclude that the preponderance of the evidence presented by Cyanotech demonstrates that retinal damage is inherent to the condition of vitamin A deficiency-induced xerophthalmia. Grangaud’s animals were kept on a vitamin A-deficient diet for about 2 months (Ex. 1002, 43), and Dowling supports a conclusion that animals kept on such a diet would have suffered retinal damage. Ex. 1026, 88–89. Dowling also supports a finding that restoration of vitamin A to the diet could reverse the damage caused by a vitamin A deficiency. Id. at 94–96. Grangaud did not administer vitamin A itself, but rather administered astaxanthin. Astaxanthin, however, is capable of being converted to vitamin A in rats, which then would be available to correct the retinal damage caused by a vitamin A-deficient diet, as well as treat ocular lesions resulting from xerophthalmia, thereby improving the vision of the rats. Pet., 14-16; Ex. 1002, 44; Ex. 1033 ¶¶ 42–43 and 51; Ex. 1045, 60 and 160. As such, the inherent action of astaxanthin would have resulted in improved vision in Grangaud’s animal model.” slip op. at 13

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

    “of all novelty in the claimed invention necessarily evidences obviousness.”); In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974). Here, Cyanotech presents substantially the same evidence for both their anticipation and obviousness challenges of claims 1, 3, 8–14, and 26. As such, and for the same reasons set forth in our anticipation analysis above, we hold that claims 1, 3, 8–14, and 26 are rendered obvious by Grangaud, alone or in combination with Dowling. Because we have determined that claims 1, 3, and 8–12 lack a novel feature with which to establish a nexus with secondary considerations, Cyanotech, as a matter of law, cannot establish a nexus. In re Kao, 639 F.3d at 1068 (Objective evidence that results from something that is not “both claimed and novel in the claim” lacks a nexus to the merits of the invention.). As to claims 2 and 4–7, the University has not directed any arguments to these claims specifically and has not made any attempts to establish a nexus between the presented objective evidence of nonobviousness and these claims. Thus, we maintain our unopposed determination that the specific doses and routes of administration recited in these claims are predictable variations within the technical grasp of a person of ordinary skill in the art, and are not persuaded by the objective evidence that claims 2 and 4–7 are nonobvious. In view of the above, we conclude that Cyanotech has demonstrated the unpatentability of claims 1–14 and 26 by a preponderance of the evidence. (2) Claim 15 Claim 15 depends from claim 14. As discussed above, we conclude that the preponderance of evidence of record demonstrates that neuronal damage to a retina is inherent to the condition of vitamin A deficiency-induced xerophthalmia. The question before us with regard to claim 15, however, is whether” slip op. at 24

  Patent outcomesUS 5,527,533 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 5,527,533
• Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.No claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,394,406
• Trivascular, Inc. v. Shaun L.W. SamuelsNo claims unpatentable
  PTAB · Dec 3, 2014 · IPR2013-00493 · APJ Richard E Rice · IPR · Final written decision

  Claims 1, 2, and 4–24 were not shown unpatentable over either instituted §103 combination because the references did not establish the required inflatable protrusions.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “not proved that claims 1, 2, 6–15, and 18–24 would have been obvious over Samuels ’851 and Todd, or that claims 1, 4–6, 9–11, 13, 14, 16, 17, and 19– 21 would have been obvious over Lazarus and Todd. Accordingly, Dr. Samuels’s Motion to Amend, which is contingent on claims 1, 14, and 23 being found unpatentable, is moot. IV. ORDER For the reasons given, it is ORDERED that claims 1, 2, and 4–24 of U.S. Patent No. 6,007,575 are not determined to be unpatentable; and FURTHER ORDERED that Dr. Samuels’s Motion to Amend is dismissed as moot.” slip op. at 24

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “TriVascular argues that “inflatable protrusions can be ‘solid’ structures such as barbs or[,] in the case of [] some of the prior art examples, solid circumferential ridges.” Reply 10 (citing Clark. Dep., Ex. 1021, 135:6–16 (discussing Samuels ’851 (Ex. 1002))). TriVascular’s proposed claim construction, however, does not accord with the plain meaning of “inflatable” as used in the Specification, i.e., expandable by being filled with fluid. See, e.g., Ex. 1001, Abstr. 3–4, 3:55 (“inflatable chamber”), 1:30 (“inflatable balloon”), 2:33, 38, 3:30 (“inflatable cuff”), 3:33–34 (“inflatable ridges”). Under the plain meaning of “inflatable” as used in the Specification, solid ridges are not “inflatable,” because they are not capable of being filled with fluid. See Resp. 5–8; In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989) (holding that the words of the claim must be given their plain meaning unless the plain meaning is inconsistent with the specification). Further, under TriVascular’s proposed claim construction, there is no meaningful difference between “protrusions” disposed on an inflatable cuff and “inflatable protrusions” disposed on an inflatable cuff. See Tr. 10:7–14. Trivascular’s proposed claim construction, therefore, fails to give any meaning to “inflatable” in “inflatable protrusions,” and by not giving effect to all words of the claim, runs afoul of a cardinal rule of claim construction. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006) (“[C]laims are interpreted with an eye toward giving effect to all terms in the claim,” so that physical structures and characteristics described specifically in a claim are not rendered “merely superfluous.”).” slip op. at 7

  • Expert testimonyPetitioner expert discountedOther

    “inflatable balloon protuberances, including “inflatable ridges.” Pet. 22 (citing Ex. 1008, Figs. 5–9), 41 & 51 (claim chart) (quoting Ex. 1008, 7:35– 39, citing Ex. 1008, Fig. 7). At oral argument, TriVascular clarified its analysis of Todd’s disclosure, and asserted that the protuberances disclosed in Todd are hollow, and themselves inflatable. Tr. 6:5–12:20. TriVascular cited in support of its position the statement in column 7 of Todd that: “When inflated, the spiral ridge 48 contacts and tightly grips the walls of a body passageway in which it is inserted.” Id. at 6–7; Ex. 1008, 7:37–39 (emphasis added); see Pet. 40–41 (Claim Chart II, element 1a-3, quoting Ex. 1008, 7:35–39). TriVascular, however, has not provided a declaration, or any other evidence, to establish that a person of ordinary skill in the art would understand Todd to disclose protuberances that are hollow, and themselves inflatable. Dr. Samuels does not agree that Todd discloses “inflatable protrusions.” Resp. 12. Dr. Samuels asserts that “the region between the inner and outer surfaces of balloon 26 of Todd is solid . . . and any provided roughened surfaces or protuberances are also solid.” Id. (citing Ex. 1008, Figs. 4 & 8; Ex. 2004). On the record before us, TriVascular has failed to show that Todd discloses “inflatable protrusions,” i.e., protrusions that are expandable by being filled with fluid. See section II.A.5 supra. The protuberances disclosed in Todd project outwardly “from the outer surface” of inflatable balloon 26. See Ex. 1008, 6:58–59, 62–63. As such, the protuberances are disposed on the exterior surface of the inflatable balloon, and are not in fluid communication with the balloon’s inner chamber 32. See Resp. 12; Ex. 1008, 7:15–16, Figs. 2, 4 & 5 (describing knobs 40 as solid structures on the outer surface of the balloon), 7:32–34, Fig. 6 (describing “cross-hatched pattern 44 projecting outwardly from the exterior surface of balloon 26”), 7:35–39, Fig. 7 (describing “outwardly projecting spiral ridge 48 wound about the exterior surface of balloon 26”), 7:40–46, Fig. 8 (describing “outwardly projecting annular rings 52 wound about the exterior surface of balloon 26”). Todd discloses expansion means in fluid communication with inner chamber 32 for inflating balloon 26 (id. at 7:53–60), but does not disclose expansion means for inflating the protuberances, either separately or in conjunction with inflation of the balloon. Todd discloses, simply, that “when balloon 26 is inflated, the gripping means [i.e., the protuberances] on the exterior of the balloon contact and grip the walls of the body passageway.” Id. at 8:14–16. Trivascular has not persuaded us, moreover, that a person of ordinary skill in the art would have understood Todd’s statement “[w]hen inflated, the spiral ridge 48 contacts and tightly grips the walls of a body passageway in which it is inserted” (id at 7:37–39 (emphasis added)), to teach or suggest that spiral ridge 48 is expandable by being filled with fluid. See Tr. 6–7. Other than that isolated statement, there is no suggestion, indication, or hint in Todd that any of the disclosed protuberances is hollow such that it can be filled with fluid and inflated. To the contrary, as discussed above, Todd” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “We determine that Trivascular has not provided a sufficient rationale to support substituting the ridges of Todd for just the barbs of Samuels ’851. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[T]here must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). TriVascular also contends that it would have been obvious to eliminate both the recesses and barbs of Samuels ’851, and to substitute “a circumferential ridge, similar to the one that is in Todd.” See Tr. 15:24– 17:15. TriVascular asserts three reasons why combining the references in that fashion would satisfy the requirement for “inflatable protrusion(s) including at least one circumferential ridge disposed about the inflatable cuff”: (1) the ridges are “inflatable” in the combination simply because they are riding on an inflatable cuff; (2) the ridges in Todd are themselves inflatable; and (3) use of ridges that are themselves inflatable would have been obvious, as they would take up less volume and be easier to insert in blood vessels than ridges that are not themselves inflatable. See id. at 17:16–18:14. None of those reasons is persuasive. The first reason is not persuasive because it does not satisfy the requirement for “inflatable protrusions,” i.e., protrusions that are expandable by being filled with fluid. See section II.A.5 supra. The second reason is not persuasive because we do not agree that Todd discloses ridges that are themselves inflatable. See section II.B.1.b supra. Lastly, the third reason is not persuasive because TriVascular has not established that a person of ordinary skill in the art would have known to use, on an inflatable cuff, circumferential ridges that are themselves inflatable. The evidence is to the contrary. See, e.g., Ex. 2002 (Samuels Decl.) ¶ 4.c (“No one else in the medical field, to the best of my knowledge, ever proposed or suggested an inflatable ridge-based sealing arrangement prior to my invention, ever.”); Ex. 1020 (Samuels Dep.), 138:20–140:7 (affirming testimony in ¶ 4.c of Samuels Decl.), 187:11–14 (testifying that inflatable ridges were not known in the medical field); Ex. 2003 (Clark Decl.) ¶ 8 (“[B]eing able to reduce the overall diameter by just deflating the fluid chamber and, correspondingly, the ridges is an intriguing concept, one which was not known, to the best of my knowledge, in the medical field prior to Samuels ’575.”); Ex. 1021 (Clark Dep.), 82:19–21 (“I’m not aware of any inflatable protrusions to support an endograft prior to Samuels [’575].”).” slip op. at 19

  Patent outcomesUS 6,007,575 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 6,007,575
• Intelligent Bio-Systems, Inc. v. Illumina Cambridge LimitedOther
  PTAB · Oct 28, 2014 · IPR2013-00266 · APJ Christopher L Crumbley · IPR · Final written decision

  The Board denied entry of substitute claims 20–26 as obvious, and granted cancellation of challenged claims 1, 2, 4, 11, 12, 17, 18, and 19.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner

    “1. the cleavable linker and the protecting group are cleavable under identical conditions Proposed substitute claim 20 recites, inter alia, “a base that is linked to a detectable label via a cleavable linker,” a “protecting group attached via the 3' oxygen atom” of the nucleotide, and a step of “removing the label and the protecting group of the nucleotide . . . under a single set of chemical cleavage conditions.” Mot. 2 (emphasis added). These limitations are similar to those present in original claim 1, which we construed in our Decision on Institution. Specifically, we construed removal of the label and the protecting group under a single set of conditions “to mean what its plain language indicates: removal of the label and the protecting group under a single set of conditions.” Dec. 6. Neither of the parties contested this construction subsequent to institution, and we discern no reason to modify our initial construction for the purposes of this decision. Proposed claim 20 also requires that the cleavable linker comprise a disulfide linkage, but does not specify the protecting group. Thus, “a single set of chemical cleavage conditions,” under the broadest reasonable interpretation standard, limits the structure of the protecting group to one which can be cleaved under the same conditions as a disulfide linkage, but does not require a specific structure, such as a disulfide linkage.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for patent owner

    “Illumina was essentially 100%. This is a significant and unexpected improvement over the disulfide cleavages of Ruby (~86%) and Herman (87%).” Ex. 2004 ¶ 84. There is no testimony, however, that the stated results were due to the claimed nucleotide rather than the reducing agent. While Dr. Romesberg refers to the “disulfide cleavage yield” as being unexpected, he does not testify that this yield was attributable to the claimed nucleotide configuration, rather than the reducing agent which performs the disulfide bond cleavage. Illumina has not distinguished the Vermaas results from the prior art by showing that the nucleotide is responsible for the disulfide yield, rather than it being a property of the disulfide bond and the yield being “the mere recognition” of the bond’s “latent properties,” which “does not render nonobvious an otherwise known invention.” Baxter, 952 F.2d at 392; In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997). Absent such evidence, Illumina has not shown that the claimed subject matter possesses “unexpected results relative to the prior art.” Galderma Labs., LP v. Tolmar, Inc., 737 F3d 731, 738 (Fed. Cir. 2013). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416.” slip op. at 28

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

    “After considering all the evidence as a whole, we conclude that Illumina has not met its burden in showing that the proposed substitute claims are patentable over the prior art considered in this Decision. The Motion to Amend is DENIED to the extent that it requests entry of substitute claims 20–26.” slip op. at 28

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,158,346

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.