• Greene’S Energy Group, LLC v. Oil States Energy Services, LLCAll claims unpatentable
  PTAB · May 1, 2015 · IPR2014-00216 · APJ James A Tartal · IPR · Final written decision

  Claims 1 and 22 are unpatentable as anticipated by Dallas ’118; the motion to amend with substitute claims 28 and 29 is denied.

  RulingsFinal written decision

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

    “member for connection to a wellhead of the well, and a locking member for detachably engaging the base member. Claim 22 contains a similar requirement. We agree with Petitioner that bottom flange 22 of Dallas ’118 corresponds to the base member of a first lockdown mechanism, and that bolts through the bores in lower flange 22 correspond to a locking member, as claimed in the ’053 patent. See Pet. 42. Claim 1 further requires a second lockdown mechanism having a range of adjustment adequate to ensure that the mandrel can be moved into the operative position, and locked down in the operative position while the first lockdown mechanism is in the lockdown position. Claim 22 contains a similar requirement. We agree with Petitioner that the hydraulic cylinder mechanism of Dallas ’118, which ensures a fluid tight seal between annular seal 78 and bit guide 84 by maintaining a pressure of about 1000 psi in upper chamber 36, corresponds to the recited second lockdown mechanism. See Pet. 36, 44.” slip op. at 18

  • 112 supportMotion to amend, deniedDenied

    “The determination of whether there is written description support turns on whether the original disclosure of the application relied upon reasonably conveys to a person of ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The proposed substitute claims introduce the term “wellhead assembly,” a term that does not appear in the ’418 application or the ’053 patent. Patent Owner’s string citation to various disclosures, none of which identify a “wellhead assembly,” is insufficient to demonstrate written description support absent some explanation. The same is true with regard to the proposed addition of language requiring both an apparatus for securing the mandrel “within a tubing head spool of a wellhead assembly” and a setting tool “arranged to insert a bottom end of the mandrel through the wellhead.” A string citation does not explain how the original disclosure of the application relied upon reasonably conveys to a person the features intended to be encompassed by the proposed substitute claims. In particular, we cannot discern from Patent Owner’s conclusory discussion how the original disclosure describes both securing the mandrel within the wellhead assembly and inserting the mandrel through the wellhead, particularly where Patent Owner further argues a distinction between inserting a mandrel “into” a wellhead as opposed to “through” a wellhead. See PO Reply. 1–2. Accordingly, we conclude Patent Owner has not satisfied its burden of showing written description support for the proposed substitute claims 28 and 29.” slip op. at 26

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

    “patentable distinction of each proposed substitute claim over the prior art. See 37 C.F.R. § 42.20(c). This includes providing a construction of new claim terms sufficient to support the distinction of the proposed substitute claim over the prior art. Patent Owner introduces the new claim terms “wellhead assembly” and “setting tool” in the proposed substitute claims, but provides no express construction of either term. Absent any discussion of what is encompassed by the recited “wellhead assembly,” it is unclear how the term differs from the use of “wellhead,” alone, elsewhere in the claim. This is particularly problematic, as discussed above, when attempting to discern what is claimed as a setting tool “arranged to insert a bottom end of the mandrel through the wellhead,” relative to the claimed apparatus for securing a mandrel “above the casing of the well and within a tubing head spool of a wellhead assembly.” In its Motion to Amend, Patent Owner also does not provide a construction for “setting tool.” We note that Patent Owner was aware that the district court had previously suggested the term “setting tool” was “ambiguous.” District Court Markman Order, Ex. 2008, 15. In reply to Petitioner’s opposition to the Motion, Patent Owner argues that “the defining characteristics of the ‘setting tool’” are set out in the claim language as: (1) “arranged to insert a bottom end of the mandrel through the wellhead,” and, (2) “separate from” the first and second lockdown mechanisms and thus “removable.” PO Reply 1. Patent Owner proceeds to dispute the construction of “setting tool” proposed by Petitioner’s Declarant, Mr. Perkin, but fails to offer any express construction of the term itself. Petitioner’s Declarant, Mr. Perkin, defined “setting tool” as “any device that is used to align the mandrel with the wellhead so that the mandrel can be inserted without interference.” Perkin Decl., Ex. 1014 ¶ 44. Patent Owner’s Declarant, Mr. Wooley, testified that “setting tool” is “usually the name given to a device for inserting some sort of tool.” Ex. 1011, 61:17–21. Absent a clear explanation of what is claimed, Patent Owner’s assertion that a particular reference does not teach “any kind of setting tool” is conclusory and not persuasive. See Mot. 9. Patent Owner has not provided a sufficient construction of the term “setting tool” by merely pointing to other claim language or by disputing Petitioner’s proposed construction. By failing to articulate adequately a construction of “setting tool” or “wellhead assembly,” Patent Owner has not satisfied its burden of showing a patentable distinction of each proposed substitute claim over the prior art. 3. Conclusion We conclude Patent Owner has not come forward with sufficient evidence to establish proposed substitute claims 28 and 29 have adequate written description support. We further conclude Patent Owner has not supported sufficiently the distinction of the proposed substitute claims 28 and 29 over the prior art by failing to provide adequately the necessary construction of the proposed amendments to claims 1 and 22. For these reasons, we deny Patent Owner’s Motion to Amend.” slip op. at 27

  Patent outcomesUS 6,179,053 unpatentable
  § 102 anticipation
  Patents in suitUS 6,179,053
• 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 · IPR2014-00034 · 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
• Baxter Healthcare Corp. / Apatech, Inc. et al. v. Millenium Biologix, LLCAll claims unpatentable
  PTAB · Mar 18, 2015 · IPR2013-00590 · APJ Michelle R Osinski · IPR · Final written decision

  Claims 1, 2, 4, 9, 11, 16–18, 20, 25, 26, 36, 38, 43, and 44 are unpatentable under § 103(a) over the stated combinations of prior art.

  RulingsFinal written decision

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

    “biomaterial compound at the same pace as that found in the natural bone remodeling process. “A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Minton v. Nat'l Ass'n of Sec. Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003). “However, when the ‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005). Determining whether to give a “whereby” or “wherein” clause patentable weight, if any, is done on a case-by-case basis. Id.; Minton, 336 F.3d at 1381; see also In re Griffin v. Bertina, 285 F.3d 1029, 1033–34 (Fed. Cir. 2002) (holding that the Board did not err by giving limited effect to the “wherein” clauses in an interference count because the wherein clauses “giv[e] meaning and purpose to the manipulative steps” rather than “merely stat[ing] the inherent result of performing the manipulative steps”). We maintain our determination that the “wherein” clauses in this case are “to be given no patentable weight beyond requiring that the recited biomaterial compound be capable of producing the recited intended results when implanted at the specified site.” Dec. 8–9. Patent Owner is attempting to read in structural limitations of the biomaterial compound, such as microporosity and macroporosity, which Patent Owner chose not to recite in claims 1 and 2 of the ’992 patent. Compare Claims 1 and 2 of the ’992 patent, with claims 9 and 18 of the ’992 patent, and claims 1 and 6 of the ’251 patent (referring to “macroporous structure” or “microporous structure”). It is improper to import such structural limitations into a wherein clause that does nothing more than recite an intended result of a positively recited process step. A “macroporous structure,” moreover, is not” slip op. at 10

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

    “establish that the progressive removal and replacement of the biomaterial compound necessarily occurs at the same pace as natural bone remodeling. Petitioner’s evidence is sufficient to support the finding that Ruys ’93a’s implanted biomaterial compound would be capable of promoting the progressive removal and replacement of the implanted biomaterial compound primarily through osteoclast and osteoblast activity because of the right chemistry (see Pet. 41–43). Patent Owner’s observations (PO Obs. 1–5) do not change our findings or conclusions. Patent Owner also argues that Ruys ’93a teaches away from the porosity which is required for the biomaterial compound to be capable of progressive removal and replacement in a time frame consistent with natural bone remodeling. PO Resp. 33 (citing Ex. 2026 ¶¶ 94–97), 47–49 (citing Ex. 1003 ¶ 368; Ex. 2026 ¶¶ 64–65). More specifically, Patent Owner argues that Ruys ’93a disparages the properties of porous HA as having low compressive strength, and desires a means for enhancing the bioactivity of HA other than porosity control. Id. at 48 (citing Ex. 1011, 3; Ex. 1014, 5, Ex. 2026 ¶¶ 77–78). Patent Owner argues that “one of skill in the art reading Ruys would have been discouraged from taking the SiCaP of Ruys and adding the structural features that the ’992 inventors determined were required to make the biomaterial capable of bioresorption and rebuilding according to the process of natural bone.” PO Resp. 49 (citing Ex. 2026 ¶¶ 66, 79). Petitioner’s position, however, is not based on modification of the biomaterial compound of Ruys ’93a to render it capable of progressive removal and replacement of the biomaterial compound. Rather, Petitioner’s position is based on Ruys ’93a inherently being capable of such progressive removal and replacement, due to its silicon-substituted CaP chemistry. Accordingly, the focus of Ruys ’93a on silicon doping rather than porosity control to improve bioactivity is immaterial to the obviousness determination in this case.” slip op. at 17

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

    “Patent Owner does not explain how a nexus exists between the asserted long-felt need for a synthetic bone graft material to replace autologous bone and the features of claims 1 and 2. In particular, Patent Owner does not identify to what it attributes the effectiveness of Skelite and/or Actifuse and whether that feature is (i) found in the claims and (ii) a novel element not in the prior art. To the extent that the effectiveness may be attributed to the substitution of silicon, for example, this feature was already present in the prior art as evidenced by Ruys ’93a. To the extent that the effectiveness may be attributed to a macroporous structure, for example, this feature is not claimed in independent claims 1 and 2. Consequently, we are not persuaded by Patent Owner’s contentions in relation to long-felt but unmet need.” slip op. at 21

  • ExcludeNot reached

    “We dismiss Petitioner’s motion as moot, because we do not rely on the objected-to timeline in our final Decision and because, even without excluding Patent Owner’s additional evidence, we have determined that Petitioner has demonstrated, by a preponderance of the evidence, that claims 1, 2, 4, 9, 11, 16– 18, 20, 25, 26, 38, 38, 43, and 44 of the ’992 patent are unpatentable.” slip op. at 39

  Patent outcomesUS 6,585,992 unpatentable
  Claim construction§ 103 obviousnesscites Phillips
  Patents in suitUS 6,585,992

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.