• 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 · IPR2014-00034 · APJ David C Mckone · IPR · Final written decision

  Claims 1, 5, 7–9, 13–18, and 20 are unpatentable as obvious under §103(a) over the specified combinations of prior art.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “psoas approach” and “when advanced in the trans-psoas path,” as recited in independent claims 1 and 9, are statements of intended use and are entitled to no patentable weight, beyond requiring an ability to follow a “trans-psoas path” or “trans-psoas approach.” Dec. 8–9; see also Marrin v. Griffin, 599 F.3d 1290, 1294 (Fed. Cir. 2010) (“For apparatus claims . . . generally patentability ‘depends on the claimed structure, not on the use or purpose of that structure.’”) (quoting Catalina Marketing Int’l v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002)); In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (“It is well settled that the recitation of a new intended use for an old product does not make a claim to that old product patentable.”). Petitioner and Patent Owner do not dispute these constructions. In view of this, and upon consideration of the complete record developed during this trial, we maintain these constructions.” slip op. at 7

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

    “Petitioner and Patent Owner do not dispute these constructions. We maintain these constructions based on the complete record developed during this trial. Neither Petitioner nor Patent Owner identifies any additional terms requiring construction. No other terms require express construction for purposes of this Decision.” slip op. at 8

  • ExcludeMotion to exclude, deniedGranted in part

    “Petitioner moves to exclude Exhibits 2033–36, 2042, and 2051 as hearsay. Mot. to Exclude 2–3. Patent Owner argues that Exhibits 2033, 2035, and 2036 are offered to show the declarants’ states of mind. Opp. to Mot. to Exclude 3–4 (citing FED. R. EVID. 803(3)). We agree that they are offered for non-hearsay purposes. Therefore, we deny the motion to exclude Exhibits 2033, 2035, and 2036. We do not rely on Exhibits 2034, 2042, and 2051. Therefore, Petitioner’s motion to exclude them is dismissed as moot. Petitioner moves to exclude Exhibits 2039, 2041, 2056, 2058, 2059, and 2066 as hearsay. Mot. to Exclude 4–5. Patent Owner introduces these exhibits as financial industry objective indicia of commercial success and praise. Patent Owner argues that these documents are introduced for non-hearsay purposes, such as showing industry praise and the states of mind of the declarants. Opp. to Mot. to Exclude 7–8. Petitioner contends that these exhibits are not reliable because the authors of those exhibits are not skilled artisans. Mot. to Exclude 4–5. We agree with Patent Owner (Opp. to Mot. to Exclude 8), however, that the credentials of the authors go to the weight of the evidence, not its admissibility. Accordingly, we deny Petitioner’s motion to exclude Exhibits 2039, 2041, 2056, 2058, 2059, and 2066. Petitioner moves to exclude Exhibit 2062 as being out of compliance with 37 C.F.R. § 42.53. Mot. to Exclude 5. We do not rely on Exhibit 2062. Therefore, Petitioner’s motion to exclude it is dismissed as moot. In sum, we deny-in-part and dismiss-in-part Petitioner’s Motion to Exclude.” slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We agree with Petitioner that the claims of the ’782 patent include aspects of both spine surgery and neurophysiology. We recognize that each declarant in this case has a particular expertise stronger in one aspect than the other. Nevertheless, we have considered the testimony of each of the declarants and have taken into account each’s respective expertise in weighing his testimony. Both parties argue that the other party’s declarant was unfamiliar with the legal standards for obviousness. PO Resp. 34–36; Reply 10. We have taken the parties’ arguments into account in weighing the testimony of the declarants. We recognize, however, that neither party’s declarants are attorneys.” slip op. at 13

  Patent outcomesUS 8,000,782 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,000,782
• Medtronic, Inc. v. Nuvasive, Inc.All claims unpatentable
  PTAB · Apr 3, 2015 · IPR2014-00074 · APJ Francisco C Prats · IPR · Final written decision

  Claims 21, 22, 24, 30, and 33–37 are unpatentable under § 103(a) over the three stated combinations of references.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedMixed

    “We agree that Exhibits 2033, 2035, and 2036 are offered for non- hearsay purposes. Therefore, we do not exclude them.” slip op. at 28

  • Skill levelSkill level board ownDecided for patent owner

    “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 10

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Further, Kelleher teaches expressly that its nerve-sensing electrodes were generally desirable when performing spinal surgery. See Ex. 1012, 1 (“[I]t is especially important to sense the presence of spinal nerves when performing spinal surgery, since these nerves are responsible for the control of major body functions.”). As noted above, Kelleher teaches also that its nerve-sensing electrodes were suitably deployed on any surgical instrument. Id. at 16. Accordingly, we are not persuaded that Kelleher would have been combined with Foley only through hindsight, as Patent Owner argues (PO Resp. 34–36, 39–40). Patent Owner argues that Drs. Watkins and Schwartz lack proper qualifications and that their testimony suffered from improper hindsight and the use of incorrect legal standards. PO Resp. 38– 41. Nevertheless, even if we accept this criticism, given the express teachings in Kelleher, Petitioner persuades us that an ordinarily skilled artisan would have been prompted to equip at least one of Foley’s dilators with Kelleher’s nerve-sensing electrodes, as claim 21 of the ’356 patent requires.” slip op. at 13

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

    “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§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,192,356
• 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
• Medtronic, Inc. v. Nuvasive, Inc.All claims unpatentable
  PTAB · Apr 3, 2015 · IPR2014-00087 · APJ David C Mckone · IPR · Final written decision

  Claims 1–12 are unpatentable as obvious over Marino, Foley, Obenchain, and Epoch 2000; claim 6 is also unpatentable with Moed.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “2. The Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art would have knowledge of both neurophysiology and spine surgery. Ex. 1012 ¶ 23. Dr. Schwartz testifies that a skilled artisan, for example, could be a neurophysiologist (like himself) with knowledge of spine surgery or access to spine surgeons or a spine surgeon with experience in neurophysiology or access to neurophysiologists. Id. Petitioner argues that Patent Owner’s declarants, although spine surgeons, lack expertise in neurophysiology. Reply 11–12. Patent Owner, relying on the testimony of Frank Phillips, M.D. (Ex. 2020, “Phillips Decl.”) ¶ 17, disagrees with Petitioner and contends that a skilled artisan would have been a surgeon who has specialized in spine surgery. Patent Owner argues that Petitioner’s declarant, Dr. Schwartz, although having expertise in neuromonitoring, is not an expert in spine surgery. PO Resp. 38–39. We agree with Petitioner that the claims of the ’535 patent include aspects of both spine surgery and neurophysiology. We recognize that each declarant in this case has a particular expertise stronger in one aspect than the other. Nevertheless, we have considered the testimony of each of the declarants and have taken into account each’s respective expertise in weighing his testimony.” slip op. at 13

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

    “Patent Owner’s arguments are unpersuasive because Patent Owner points out deficiencies of individual references without adequately addressing their combined teachings. See In re Keller, 642 F.2d 413, 426 (CCPA 1981) (“[O]ne cannot show non-obviousness by attacking references individually where, as here, the rejections are based on combinations of references.”).” slip op. at 18

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

    “Patent Owner’s objective evidence of non-obviousness is centered on praise for, and success of, its “eXtreme Lateral Interbody Fusion” (XLIF) systems and methods. See, e.g., PO Resp. 12–14. Patent Owner, however, does not establish adequately what XLIF is and whether it is encompassed by the claims of the ’535 patent. Patent Owner repeatedly refers to features of this technique with a high degree of generality, for example stating that it is “the first minimally invasive lateral transpsoas approach to the lumbar spine using nerve monitoring,” id. at 13, and quoting an article that describes features of XLIF used in conjunction with another Patent Owner product (EMG IOM, or NeuroVision®), id. We are unable to discern, from such general evidence, how Patent Owner is mapping the features of XLIF to the claims. Patent Owner argues that Dr. Phillips, in his Declaration, compared XLIF to the independent claims of the ’535 patent and concluded that “XLIF procedure and systems” embody those claims. PO Resp. 14 (citing Ex. 2020 ¶¶ 22–23, 27, Attachment E). Dr. Phillips, in turn, includes detailed claim charts and citations to literature that purportedly describes an “XLIF System.” See Ex. 2020, Attachment E. Patent Owner makes no attempt, however, to explain in its Response how this evidence establishes a nexus. Instead, it is an improper incorporation by reference of arguments from the Phillips Declaration into the PO Response. See 37 C.F.R. § 42.6(a)(3) (“Arguments must not be incorporated by reference from one document into another document.”). Additionally, it is unclear what product(s) Dr. Phillips is mapping to the claims. Dr. Phillips cites to Exhibit 2028, which he alternately contends describes the “XLIF surgical technique” and the “XLIF system.” Ex. 2020 ¶ 22, Attachment E, p. 168. As its title suggests, however, Exhibit 2028 appears to describe a MaXcess II Access System, with XLIF being one surgical technique performable with this system. Ex. 2028, at 1. To the extent XLIF is a “system,” it appears that such a system would not correspond to the claims of the ’535 patent. For example, the XLIF instrument system includes several surgical devices, but does not include any cannulated devices with nerve monitoring capability. Ex. 2028, at 4. Rather, Dr. Phillips relies on disclosure of the MaXcess II Access system to show these features. Ex. 2020, Attachment E, p. 173–64, 178–79 (citing Ex. 2028, at 8). Another portion of the document details the catalog numbers of the components of the “XLIF System,” none of which includes cannulated devices with nerve monitoring capability. Ex. 2028, at 24. In contrast, dilators are included in the “MaXcess II Access System,” id. at 26, and nerve monitoring appears to be provided by a “NeuroVision JJB System” and disposable “NeuroVision JJB XLIF Module,” id. at 27. It appears, from this evidence, that XLIF is a marketing term that is” slip op. at 22

  • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersDecided for petitioner

    “Although Patent Owner has introduced evidence to show that each of the possible approaches has disadvantages and risks of patient injury, Patent Owner’s evidence does not show that there was a long-felt need for a safe, reproducible lateral trans-psoas approach to the spine. Rather, at most, it shows that surgeons weighed the risks of each approach and opted for anterior and posterior approaches. Indeed, Petitioner introduces evidence that approaches other than lateral trans-psoas still comprise the majority of such spinal surgeries today. Reply 5. Patent Owner’s evidence is not sufficient to show a long-felt need. The existence of alternative approaches to the lumbar spine supports a finding that the need for a suitable approach to the lumbar spine had been solved. That those alternative approaches may have presented their own difficulties does not persuade us that there was a long-felt need for the lateral trans-psoas pathway, absent evidence that widespread efforts by ordinarily skilled artisans had failed in that trans-psoas approach. See Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed. Cir. 2004) (“[T]he mere passage of time without the claimed invention is not evidence of nonobviousness.”) (citation omitted); In re Allen, 324 F.2d 993, 997 (CCPA 1963) (An allegation of a long-felt but unsolved problem in the art “is not evidence of unobviousness unless it is shown . . . that the widespread efforts of skilled workers having knowledge of the prior art had failed to find a solution to the problem.”). Even assuming Patent Owner’s evidence shows a long-felt need, Patent Owner has not shown that such a need was met by the invention of the ’535 patent. To show that such a need was met, Patent Owner argues that its XLIF solution uses nerve monitoring to safely traverse the psoas muscle in an extreme lateral approach. PO Resp. 13. As explained in Section II.D.5.a above, Patent Owner’s evidence does not establish a nexus between XLIF (or an extreme lateral approach) and the claims. Accordingly, we are not persuaded by Patent Owner’s evidence of long-felt need or its product’s satisfaction of such a need.” slip op. at 26

  Patent outcomesUS 8,005,535 unpatentable
  § 103 obviousnesscites Graham
  Patents in suitUS 8,005,535
• Medtronic, Inc. v. Nuvasive, Inc.All claims unpatentable
  PTAB · Apr 3, 2015 · IPR2014-00081 · APJ David C Mckone · IPR · Final written decision

  Claims 1–12 are unpatentable as obvious under the five stated § 103(a) grounds, including the Foley-based combinations and the Kelleher-based combinations.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningTerm construed board ownDecided for petitioner

    “In the Decision to Institute, we preliminarily construed “trans-psoas path” to mean “a path in which the instrument passes through the psoas muscle.” Dec. 8–9. We specifically rejected Patent Owner’s position that the ’535 patent limits “trans-psoas approach” to an approach through the middle or posterior portion of the psoas muscle. Id. We also preliminarily construed “initial dilator cannula” to carry its ordinary meaning. Id. at 9. We rejected Patent Owner’s argument that the initial dilator cannula must be the particular structure that defines a path in such a manner that sequential dilator cannulas are advanced in that same path and a working corridor instrument is advanced over the sequential dilator cannulas. Id. Petitioner and Patent Owner do not dispute these constructions in the PO Response or Reply. In view of this, and upon consideration of the complete record developed during this trial, we maintain these constructions.” slip op. at 7

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

    “Petitioner argues that the teachings of each of these references are in the context of improving minimally invasive spine surgery using cannulated instruments. Pet. 23. According to Petitioner, a skilled artisan would have had reason to combine Foley, Marino, Obenchain, and NIM Guide because the nerve detection techniques of Marino and NIM Guide specifically are intended to make the surgical procedures of Foley and Obenchain safer. Id. at 23–24. Marino, for example, states that “[a]n advantage of determining the position of a para-spinal nerve with respect to the distal tip of the cannula in particular is that the para-spinal nerve can be avoided or gently moved out of the surgeon’s way while inserting the cannula.” Ex. 1005, 2:17–21. NIM Guide explains that its monitoring device “will assist early nerve identification by providing the surgeon with a tool to help locate and identify the particular nerve at risk within the surgical field” and “will continuously monitor EMG activity from the muscles innervated by the nerve at risk to minimize trauma and enhance neural preservation by alerting the surgeon when a particular nerve has been activated.” Ex. 1009, 1:5–11. Petitioner further argues that Marino teaches that the elongate stimulation instrument received within Marino’s cannula reduces the risk of nerve damage during spine surgery, and that such teaching would have been applicable to Foley’s procedures. Pet. 23–24.” slip op. at 16

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

    “systems and methods. See, e.g., PO Resp. 12–14. Patent Owner, however, does not establish adequately what XLIF is and whether it is encompassed by the claims of the ’535 patent. Patent Owner repeatedly refers to features of this technique with a high degree of generality, for example stating that it is “the first minimally invasive lateral transpsoas approach to the lumbar spine using nerve monitoring,” id. at 12, and quoting an article that describes features of XLIF used in conjunction with another Patent Owner product (EMG IOM, or NeuroVision®), id. at 13. We are unable to discern, from such general evidence, how Patent Owner is mapping the features of XLIF to the claims. Patent Owner argues that Dr. Phillips, in his Declaration, compared XLIF to the independent claims of the ’535 patent and concluded that “XLIF procedure and systems” embody those claims. PO Resp. 14 (citing Ex. 2020 ¶¶ 22–23, 27, Attachment E). Dr. Phillips, in turn, includes detailed claim charts and citations to literature that purportedly describes an “XLIF System.” See Ex. 2020, Attachment E. Patent Owner makes no attempt, however, to explain in its Response how this evidence establishes a nexus. Instead, it is an improper incorporation by reference of arguments from the Phillips Declaration into the PO Response. See 37 C.F.R. § 42.6(a)(3) (“Arguments must not be incorporated by reference from one document into another document.”).” slip op. at 23

  • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersDecided for petitioner

    “Although Patent Owner has introduced evidence to show that each of the possible approaches has disadvantages and risks of patient injury, Patent Owner’s evidence does not show that there was a long-felt need for a safe, reproducible lateral trans-psoas approach to the spine. Rather, at most, it shows that surgeons weighed the risks of each approach and opted for anterior and posterior approaches. Indeed, Petitioner introduces evidence that approaches other than lateral trans-psoas still comprise the majority of such spinal surgeries today. Reply 5. Patent Owner’s evidence is not sufficient to show a long-felt need. The existence of alternative approaches to the lumbar spine supports a finding that the need for a suitable approach to the lumbar spine had been solved. That those alternative approaches may have presented their own difficulties does not persuade us that there was a long-felt need for the lateral trans-psoas pathway, absent evidence that widespread efforts by ordinarily skilled artisans had failed in that trans-psoas approach. See Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed. Cir. 2004) (“[T]he mere passage of time without the claimed invention is not evidence of nonobviousness.”) (citation omitted); In re Allen, 324 F.2d 993, 997 (CCPA 1963) (An allegation of a long-felt but unsolved problem in the art “is not evidence of unobviousness unless it is shown . . . that the widespread efforts of skilled workers having knowledge of the prior art had failed to find a solution to the problem.”). Even assuming Patent Owner’s evidence shows a long-felt need, Patent Owner has not shown that such a need was met by the invention of the ’535 patent. To show that such a need was met, Patent Owner argues that its XLIF solution uses nerve monitoring to safely traverse the psoas muscle in an extreme lateral approach. PO Resp. 13. As explained in Section II.D.1.d(1) above, Patent Owner’s evidence does not establish a nexus between XLIF (or an extreme lateral approach) and the claims. Accordingly, we are not persuaded by Patent Owner’s evidence of long-felt need or its product’s satisfaction of such a need.” slip op. at 27

  Patent outcomesUS 8,005,535 unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 8,005,535
• 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
• Gnosis S.P.A. / Gnosis Bioresearch S.A. et al. v. Merck & CieAll claims unpatentable
  PTAB · Jun 20, 2014 · IPR2013-00117 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 8, 9, 11, 12, 14, 15, and 19-22 are unpatentable under §102 over Serfontein and/or §103 over Serfontein with Marazza, and for claims 11, 12, 14, 15, 21, and 22 with Ubbink.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “administering at least one tetrahydrofolate in natural stereoisomeric form to a human subject,” where the tetrahydrofolate is, for example, “5-methyl-(6S)- tetrahydrofolic acid” or a salt thereof. Ex. 1004, challenged claims. Nothing in the challenged claims themselves, nor the specification of the ’040 patent, indicates that the phrase “5-methyl-(6S)-tetrahydrofolic acid” refers to the natural isomer only when it is substantially free of its non-natural enantiomer, i.e., excludes the non-natural isomer present in a mixture of isomers. In fact, the claims and specification do not mention or define “substantially free” (a term proffered by Merck) in any context, and Merck does not suggest otherwise. Resp. 2-5. Even assuming, as Merck points out, that “examples of the ’040 patent describe compositions containing only the natural isomer,” such examples do not correspond to the entire disclosure in the specification, or otherwise dictate that we import a limitation into the claim that is not recited. Id. at 4; see Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1354 (Fed. Cir. 2012) (“While claim terms are understood in light of the specification, a claim construction must not import limitations from the specification into the claims”); Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004) (“[E]ven where a patent describes only a single embodiment, claims will not be ‘read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using ‘words or expressions of manifest exclusion or restriction’” (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)). The claims and specification of the ’040 patent, as a whole, do not indicate that the recited methods comprising administering L-5-MTHF exclude administering a mixture comprising both L-5-MTHF (natural form) and D-5- MTHF (non-natural form). A broadest reasonable reading of the challenged claims as a whole, in the context of the entire disclosure in the ’040 patent, indicates that one may meet the challenged claims if, inter alia, one administers “5-methyl-(6S)- tetrahydrofolic acid” (L-5-MTHF), regardless of whether one administers it as part of a mixture with other things, such as the corresponding non-natural isomer. There is no requirement in any challenged claim that one must administer L-5- MTHF or its salt by itself, substantially free of its enantiomer, or otherwise separate from a mixture comprising both L-5-MTHF and D-5-MTHF.” slip op. at 9

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “The issue then becomes whether an ordinary artisan would have envisaged, at once, each member of a limited class of compounds encompassed by the phrase “suitable active metabolite of folate” in Serfontein. See Petering, 301 F.2d at 681. Merck does not dispute Gnosis’s position that one would have envisioned the eight reduced folate compounds, including 5-methyl-tetrahydrofolic acid (N5-methyl THFA or 5-MTHF), disclosed in Modern Nutrition (Ex. 1007, 391-392) in some form when reading the phrase “suitable active metabolite of folate” in Serfontein (Ex. 1009, 4). Accord Tr. 25:1 21. Rather, Merck essentially argues that one would have envisaged “thousands” of sub-species of compounds or preparations falling with the eight species of compounds falling within the genus of “suitable active metabolites of folate” disclosed in Serfontein. Resp. 7. The challenged claims at issue, however, recite compounds in terms of a “tetrahydrofolate in natural stereoisomeric form,” and more specifically, in terms of seven THF compounds, such as 5-methyl-(6S)-tetrahydrofolic acid (i.e., L-5-MTHF), or their salts generally. Thus, the claims do not recite, and are not limited to, any specific salt, polyglutamate and/or crystalline form or preparation type. Thus, even assuming one would have envisaged “thousands” of unclaimed salt, polyglutamate and/or crystalline forms or preparations, as Merck contends, such a fact does not undermine Gnosis’s contention, and evidence in support, indicating that one would have envisaged a small number of compounds, including 5-methyl-(6S)-tetrahydrofolic acid or its salt, i.e., the “natural” form of 5-MTHF, when reading the phrase “suitable active metabolite of folate” in Serfontein. On this record, we are persuaded by Dr. Miller’s testimony that an ordinary artisan reading the phrase “suitable active metabolite of folate” in Serfontein would have at once envisaged each of the compounds in the small number of compounds that Dr. Miller identifies, including 5-methyl-(6S)-tetrahydrofolic acid, as recited in challenged claims.6 Testimony by Dr. Gregory (Ex. 2001 ¶¶ 66-82), cited by” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundTeaching away not foundDecided for petitioner

    “knowledge of Serfontein and Marazza. Marazza expressly discloses salts of 5- MTHF and describes processes for separating the natural “6S” form of 5-MTHF from the “unnatural (6R)-diastereoisomer.” Ex. 1012, 1:10-19, 1:55-2:20. Because Marazza taught that “[t]here exists an increasing interest for the application of this natural metabolite [(L-5-MTHF)] as at least one active compound in a therapeutic agent, for example as vitamin in folate deficient states,” an ordinary artisan would have had reason to use L-5-MTHF as the “suitable active metabolite of folate” in Serfontein’s method. Id. at 1:25-28; Ex. 1009, 4:37-42.” slip op. at 19

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

    “It is not sufficient, however, that a product or its use merely falls within the scope of a claim in order for objective evidence of nonobviousness tied to that product to be given substantial weight. There must also be a causal relationship, termed a “nexus,” between the evidence and the claimed invention. Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1376 (Fed. Cir. 2005). A showing of sufficient nexus is required in order to establish that the evidence relied upon traces its basis to a novel element in the claim, not to something in the prior art. Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). 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. In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011). Nexus must exist in relation to all types of objective evidence of nonobviousness. GPAC, 57 F.3d at 1580 (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); Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1313 (Fed. Cir. 2006) (failure of others); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need); Kao, 639 F.3d at 1069 (unexpected results); Stamps.com Inc. v. Endicia, Inc., 437 F. App’x 897, 905 (Fed. Cir. 2011) (skepticism); Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1328 (Fed. Cir. 2008) (praise). Thus, for objective evidence to be accorded substantial weight, the record “must establish a nexus between the evidence and the merits of the claimed invention.” GPAC, 57 F.3d at 1580. Moreover, establishing nexus involves a showing that novel elements in the claim, not prior-art elements, account for the objective evidence of nonobviousness. See Kao, 639 F.3d at 1068. As the Federal Circuit explains, “[t]o the extent that the patentee demonstrates the required nexus, his objective evidence of nonobviousness will be accorded more or less weight.” GPAC, 57 F.3d at 1580. Thus, the stronger the showing of nexus, the greater the weight accorded the objective evidence of nonobviousness. See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 306 (Fed. Cir. 1985).” slip op. at 31

  Patent outcomesUS 6,011,040 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 6,011,040
• Corning Incorporated v. DSM IP Assets B.V.No claims unpatentable
  PTAB · May 9, 2014 · IPR2013-00049 · APJ Scott E Kamholz · IPR · Final written decision

  Corning failed to prove claims 53–66 unpatentable because it did not establish the claimed change-in-length property and other required limitations for the asserted grounds.

  RulingsFinal written decision

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

    “The evidence supports a conclusion that the broadest reasonable interpretation of the term “moisture” is liquid water—that is, a condition of 100% relative humidity. The written description uses the term “moisture” in a context that suggests liquid water. See, e.g., Ex. 1001, 28:65-67 (applying a “wax/water slurry” to surface of sample film in order “to retain moisture”); 35:17-18 (applying heat to remove “moisture” from samples, suggesting removal of liquid water). Moreover, where the written description discusses water in vapor form, the inventors use the word “humidity” or “atmospheric moisture,” but not “moisture” alone. See, e.g., id. at 21:47 (referring to “atmospheric moisture”); 28:48, 60, 65 (referring to “humidity”). The ’189 patent further discloses that a “ribbon assembly can be buried under ground or water for long distance connections, such as between cities,” which is consistent with the proposition that an optical fiber coating must endure long periods of immersion in liquid water without delaminating. Ex. 1001, 67:43-45. In light of the context in which the term “moisture” appears in the specification, we conclude that the inventors used that term in its ordinary sense to refer to liquid water. The ’189 patent, thus, is directed to a coating composition that, after radiation cure, has sufficient adhesion to glass to prevent delamination in the presence of liquid water. We decline to resolve what temperature, or length of time of exposure to liquid water the coating must endure, without delaminating, in order to satisfy the claimed adhesion property. Resolving those conditions is not necessary to our analysis, which focuses on whether Corning’s wet adhesion test, conducted under conditions of 95% relative humidity, is probative of the extent to which a cured coating delaminates from glass when exposed to liquid water.” slip op. at 8

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

    “We do not agree with Corning that the ’189 patent defines the term “stripping temperature” as “about 90°C to about 120°C.” Rather, the patent indicates that stripping temperature is “typically” within this range. Ex. 1001, 13:32-34; accord id. at 14:21-25 (“[F]or most coating compositions the design ribbon stripping temperatures are usually about 90° C. to about 120° C., but may be different depending on the specific design parameters for the particular coating composition.”). This disclosure is too imprecise to serve as a definition. See Paulsen, 30 F.3d at 1480. The ’189 patent does refer repeatedly, however, to 90°C as an exemplary stripping temperature. E.g., Ex. 1001, 31:14-15, 31:41-42, 50:55. The ’189 patent also identifies 100°C as an exemplary stripping temperature, particularly in the context of measuring change in length. Id. at 14:46-47, 18:44-45. Whatever other temperatures this term encompasses, it certainly encompasses at least the ones specifically identified. See Oatey Co. v. IPS Corp., 514 F.3d 1271, 1276 (Fed. Cir. 2008) (“We normally do not interpret claim terms in a way that excludes embodiments disclosed in the specification.”). The limitation requires no further construction.” slip op. at 10

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “excluded and given little or no weight. Resp. 45-47; PO Mot. To Exclude 1- 6. We address the admissibility of Dr. Winningham’s testimony below in our decision on DSM’s motion to exclude evidence. To the extent that DSM’s argument goes to the weight to be accorded Dr. Winningham’s testimony, it is not persuasive. DSM identifies no particular instances in which Dr. Winningham’s silence as to the relevant time period for determining who is one of skill in the art weakens his testimony. We agree with Corning that the thoroughness of Dr. Winningham’s testimony outweighs the concern DSM expresses. We also are not persuaded that Dr. Winningham made the admission that DSM argues. DSM’s question appears to address whether Dr. Winningham made any distinctions about the qualifications and experience of a skilled scientist over time, not whether Dr. Winningham based his obviousness opinions on the knowledge of that skilled scientist at the time the invention was made. We do not find Dr. Winningham’s supposed admission determinative on the issue of whether he failed to consider the relevant time period in his obviousness opinions.” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable

    “In sum, two independent reasons support our determination that the wet adhesion test results advanced by Corning fail to show adequately that the Szum coating has “sufficient adhesion . . . to prevent delamination in the presence of moisture” within the meaning of the challenged claims. First, the wet adhesion test assesses a property of the coating after conditioning at 95% relative humidity, which is not “in the presence of moisture.” Second, Corning identifies no persuasive evidence from which we reasonably can discern that the wet adhesion test evaluates for “delamination.”” slip op. at 24

  Patent outcomesUS 6,298,189 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 6,298,189

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.