Medtronic, Inc.v.NuVasive, Inc.Download PDFPatent Trial and Appeal BoardApr 3, 201512635418 (P.T.A.B. Apr. 3, 2015) Copy Citation Trials@uspto.gov Paper 48 Tel: 571-272-7822 Entered: April 3, 2015 UNITED STATES PATENT AND TRADEMARK OFFICE _______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _______________ MEDTRONIC, INC., Petitioner, v. NUVASIVE, INC., Patent Owner. _______________ Case IPR2014-00073 Patent 8,192,356 B2 _______________ Before FRANCISCO C. PRATS, SCOTT E. KAMHOLZ, and DAVID C. McKONE, Administrative Patent Judges. PRATS, Administrative Patent Judge. FINAL WRITTEN DECISION 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 Case IPR2014-00073 Patent 8,192,356 B2 2 I. INTRODUCTION A. Statement of the Case Medtronic, Inc. (“Petitioner”) filed a Corrected Petition (Paper 8, “Pet.”) requesting an inter partes review of claims 21, 22, 24–26, 30, and 33–37 of U.S. Patent No. 8,192,356 B2 (Ex. 1018, “the ’356 patent”). NuVasive, Inc. (“Patent Owner”) filed a Preliminary Response (Paper 10, “Prelim. Resp.”). Petitioner relied upon the following references to show unpatentability: Ex. 1001 Cistac DE 100 48 790 A1 Apr. 25, 20021 (as translated, Ex. 1002) Ex. 1003 Kelleher WO 01/37728 A1 May 31, 2001 Ex. 1004 Obenchain US 5,313,962 May 24, 1994 Ex. 1005 Mathews US 5,171,279 Dec. 15, 1992 Ex. 1006 Koros US 6,139,493 Oct. 31, 2000 Ex. 1007 Michelson US 5,772,661 June 30, 1998 Ex. 1008 Jones US 4,595,013 June 17, 1986 Ex. 1009 Branch US 6,945,933 B2 Sept. 20, 2005 (filed June 26, 2002) Ex. 1010 Blewett WO 03/005887 A2 Jan. 23, 2003 (filed July 11, 2002) 1 Petitioner asserts that, “[r]egardless of the priority filing date of the ’356 patent,” Cistac is prior art under 35 U.S.C. § 102(b) because it was “published more than a year prior to June 26, 2002.” Pet. 6. The first page of the Cistac document shows a publication date of April 25, 2002, however. Ex. 1001, 1. Case IPR2014-00073 Patent 8,192,356 B2 3 Ex. 1011 Onimus WO 00/27291 A1 May 18, 2000 (as translated, Ex. 1012) Ex. 1013 NIM Guide MEDTRONIC XOMED SURGICAL PRODUCTS, INC., NIM-RESPONSETM, NERVE INTEGRITY MONITOR, INTRAOPERATIVE EMG MONITOR USER’S GUIDE (2000). We instituted inter partes review of claims 21, 22, 24, 30, and 33–37 on the following grounds of unpatentability: References Basis Claims challenged Cistac, Obenchain, Kelleher, and Mathews § 103(a) 21, 30, 33, and 34 Cistac, Obenchain, Kelleher, Mathews, and Koros § 103(a) 22 and 24 Cistac, Obenchain, Kelleher, Mathews, and NIM Guide § 103(a) 35 Cistac, Obenchain, Kelleher, Mathews, NIM Guide, and Jones § 103(a) 36 and 37 Branch, Obenchain, Blewett, and Onimus § 103(a) 21, 30, and 33–37 Branch, Blewett, Obenchain, Onimus, and Koros § 103(a) 22 and 24 Decision to Institute 32 (Paper 14, “Dec.”). After trial was instituted, Patent Owner filed a Response (Paper 26; “PO Resp.”) and Petitioner filed a Reply (Paper 31, “Reply”). Petitioner filed a Motion to Exclude Evidence. Paper 34 (“Mot. to Exclude”). Patent Owner filed an Opposition to the Motion to Exclude Evidence. Paper 39 (“PO Opp.”). Petitioner filed a Reply to the Opposition to the Motion to Exclude Evidence. Paper 42 (“Reply to Opp.”). Case IPR2014-00073 Patent 8,192,356 B2 4 Patent Owner filed a Motion for Observations on Cross Examination. Paper 36 (“PO Mot. Obs.”). Petitioner filed a Response to that Motion. Paper 38 (“Resp. to Mot. Obs.”). Petitioner supported its Petition with Declarations by Robert G. Watkins, IV, M.D. (“Watkins Pet. Decl.” (Ex. 1015)), Daniel Schwartz, Ph.D. (“Schwartz Decl.” (Ex. 1016)), and David Hacker (“Hacker Decl.” (Ex. 1017)). Petitioner supported its Reply with a second Declaration by Dr. Watkins (“Watkins Reply Decl.” (Ex. 1024)). In support of its Response, Patent Owner relied on Declarations by Frank Phillips, M.D. (“Phillips Decl.” (Ex. 2020)), Patrick Miles (“Miles Decl.” (Ex. 2024)), and Theodore G. Obenchain, M.D. (“Obenchain Decl.” (Ex. 2025)). Oral Hearing was held on December 4, 2014, and the Hearing Transcript (“Tr.”) has been entered in the record. Paper 47. We have jurisdiction under 35 U.S.C. § 6(c). This Final Written Decision is entered pursuant to 35 U.S.C. § 318(a). “In an inter partes review instituted under this chapter, the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). 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. Petitioner’s Motion to Exclude Evidence is denied-in-part, and dismissed-in-part as moot. Case IPR2014-00073 Patent 8,192,356 B2 5 B. Related Cases Patent Owner has asserted the ’356 patent against Petitioner in Warsaw Orthopedic Inc. v. NuVasive Inc., Case No. 3:12-cv-02738-CAB- MDD (S.D. Cal.). Pet. 1; Paper 6 at 2. In Medtronic, Inc. v. NuVasive, Inc., IPR2014-00074, we instituted review of claims 21, 22, 24, 30, and 33–37 of the ’356 patent, on a distinct set of grounds presented by Petitioner. IPR2014-00074, Paper 15. Petitioner also has challenged a number of related patents in the following proceedings in which trials were instituted: IPR2014-00034 (Patent 8,000,782), IPR2014-00075 (Patent 8,016,767), IPR2014-00081 (Patent 8,005,535), and IPR2014-00087 (Patent 8,005,535). These proceedings also were argued at the December 4, 2014, oral hearing. C. The ’356 Patent The ’356 patent describes methods and apparatuses for accessing a surgical target site, such as the lumbar spine, using minimally invasive techniques. Ex. 1018, 1:30–2:58. The surgical target site is accessed by first advancing a rigid, generally narrow (diameter about 1.5 millimeters), “K- wire” through the patient’s tissue to the target site. Id. at 6:51–59. Then, tissue dilators of increasing diameter are advanced over the K-wire to the target site, so as to sequentially distract, that is, open up, an initial pathway through the tissue to the site. Id. at 6:65–7:23. Once the initial pathway through the tissue is formed, an operative corridor for performing the surgery may be prepared by advancing a set of retractor blades into the tissue opening, and attaching the blades to a pivot linkage. Id. at 8:15–30, see also Figs. 8, 32 (showing pivot linkage 14 and attached retractor blades 90, 92). The pivot linkage has handle-like pivot Case IPR2014-00073 Patent 8,192,356 B2 6 arms that allow the surgeon to spread the tissue-distracting elements farther apart. See id. at Fig. 8 (showing pivot arms 60, 62, 64, and 66). The ’356 patent explains that “retractor blades 90, 92 may be locked in a desired position by tightening the respective nuts 82, 86 of the locking assemblies 32, 34.” Id. at 8:28–30, see also Fig. 8. Once an operative corridor is established, the surgeon can perform surgical procedures, such as installing a spinal fusion implant. Id. at 6:31–35. The ’356 patent discloses that any of the tissue-distracting instruments, including dilators and retractor blades, may be equipped with stimulation electrodes that allow the surgeon to monitor the location of nerves in the patient, so as to avoid and not damage the nerves during surgery. See id. at 9:40–59. The electrodes emit a stimulation signal that, when sufficiently close to a nerve, causes an innervation response in the muscle associated with the nerve. Id. at 9:51–57. Response to the stimulation signal may be monitored visually, by a twitch in the muscle, or detected using an electromyography (EMG) system, which includes electrodes positioned on the patient’s muscles. Id. at 9:60–10:23, 11:14–32. Claim 21, the only independent claim Petitioner challenges in this proceeding, reads as follows: 21. A system for accessing a spinal disc of a lumbar spine through an operative corridor, comprising: a distraction assembly to create a tissue distraction corridor to a lumbar spine, wherein said distraction assembly comprises: an elongate penetration member deliverable to a spinal disc along a lateral, trans-psoas path to the lumbar spine such that a distal tip region of the elongate penetration member penetrates into an annulus of a spinal disc Case IPR2014-00073 Patent 8,192,356 B2 7 in the lumbar spine, and at least two dilators of sequentially larger diameter deliverable to the spinal disc along the lateral, trans-psoas path to the lumbar spine, a first dilator of the at least two dilators having a lumen configured to slidably receive the elongate penetration member, at least one of said at least two dilators including a stimulation electrode to deliver electrical stimulation for nerve monitoring when said stimulation electrode is positioned in the lateral, trans-psoas path to the lumbar spine; and a retraction assembly comprising a plurality of retractor blades that enlarge the tissue distraction corridor to thereby form an operative corridor along the lateral, trans-psoas path to the lumbar spine when the plurality of retractor blades are delivered to the lumbar spine, the retraction assembly further comprising a blade holder apparatus that is configured to releasably lock with the plurality of retractor blades, wherein when the plurality of retractor blades enlarge the tissue distraction corridor to form the operative corridor along the lateral, trans-psoas path to the lumbar spine, the operative corridor is dimensioned so as to pass an implant through the operative corridor along the lateral, trans-psoas path to the lumbar spine. Id. at 18:60–19:24 (emphases added). II. ANALYSIS A. Claim Construction The Board interprets claims using the “broadest reasonable construction in light of the specification of the patent in which [they] Case IPR2014-00073 Patent 8,192,356 B2 8 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. B. Effective Filing Date of the ’356 Patent As discussed below, the disposition of the challenges based on the Blewett reference depends on the priority date accorded to the challenged claims. The ’356 patent claims priority to U.S. Provisional Application No. 60/392,214 (Ex. 1019, “the ’214 application”), filed June 26, 2002. Ex. 1018, 1:10–13. Petitioner contends that the ’356 patent is not entitled to the benefit of the ’214 application’s filing date because the ’214 application does not provide descriptive support for the blade holder apparatus being “configured to releasably lock” with the plurality of retractor blades, as recited in claim 21. Pet. 12; Ex. 1018, 19:17 (claim 21). In the Institution Decision, on the record before us at that time, we preliminarily found that claim 21 of the ’356 patent was not entitled to the Case IPR2014-00073 Patent 8,192,356 B2 9 benefit of the ’214 application’s filing date. Dec. 10–11. Patent Owner responds that, based on images and handwritten notations in the ’214 application, and the supporting testimony of Dr. Phillips, an ordinarily skilled artisan would have understood that the releasably locking blade holder apparatus recited in claim 21 was adequately described in the ’214 application. PO Resp. 47–54. As noted above, Petitioner bears the ultimate burden of showing unpatentability by a preponderance of the evidence. 35 U.S.C. § 316(e). Nonetheless, to establish descriptive support for a claim, “the written description must include all of the limitations . . . , or the [proponent] must show that any absent text is necessarily comprehended in the description provided and would have been so understood at the time the patent application was filed.” Hyatt v. Boone, 146 F.3d 1348, 1354–55 (Fed. Cir. 1998) (emphasis added). We find, in light of Patent Owner’s contentions, that Petitioner has not shown by a preponderance of the evidence that claim 21 of the ’356 patent lacks descriptive support in the ’214 application. The feature of claim 21 allegedly absent from the disclosure of the ’214 application is “a blade holder apparatus that is configured to releasably lock with the plurality of retractor blades.” Ex. 1018, 19:16–18. To show that an ordinarily skilled artisan necessarily would have comprehended this structure in the ’214 application, Patent Owner directs us (PO Resp. 48–54) to the color images of Figures 28–35, 43–46, 47–49, and 51–53 in the ’214 Case IPR2014-00073 Patent 8,192,356 B2 10 application (see Ex. 2026, 49–104),2 black and white images corresponding to a number of those color images (id. at 36–48), as well as handwritten annotations to those images presented in the original disclosure of the ’214 application. In particular, Patent Owner contends, and Dr. Phillips testifies, that Figure 28B of the ’214 application (Ex. 2026, 78) shows three cylindrical rods extending from the pivot linkage assembly (blade holder apparatus) of the shown retractor, and Dr. Phillips identifies those rods as bolts, with the right-most bolt having a nut tightened to it. PO Resp. 49; Ex. 2020 ¶ 83 (Phillips Decl.). Dr. Phillips testifies that Figure 35, depicting a later step in the surgical procedure, shows posterior retractor blade 14 releasably locked to the pivot linkage assembly by the nut and bolt assembly. Ex. 2020 ¶ 83. Dr. Phillips notes that the annotations to the black and white version of Figure 35 support this conclusion by stating that the posterior retractor blade is “locked in place on speculum assembly.” Id. (emphasis omitted) (citing Ex. 2026, 44 (“132sen.jpg”)). Dr. Phillips testifies that the annotations to the black and white versions of Figures 46 and 48, 142sen.jpg and 145sen.jpg, respectively, similarly describe locking the anterior and caudal retractor blades to the pivot linkage assembly using a nut and bolt assembly. Ex. 2020 ¶¶ 84, 85. As to the releasability of the retractor blades, Dr. Phillips testifies that an ordinarily skilled artisan viewing the figures of the ’214 application necessarily would have understood the retractor blades to be releasably 2 We cite to the page numbers inserted at the bottom of each page of Exhibit 2026. Case IPR2014-00073 Patent 8,192,356 B2 11 locked in place, because the ’214 application describes no evident mechanism by which the blades would be permanently locked into position. Id. ¶ 81. Dr. Phillips testifies further that permanently locking the blades in place would have rendered the device unusable, making removal from the patient, as well as re-use of the device, impractical. Id. ¶ 82. Dr. Phillips testifies, therefore, that “I do not believe there is any basis to conclude that the locking mechanism shown in the figures for affixing the blades to the handle is somehow not a releasable locking mechanism. To the contrary, the disclosure necessarily discloses a releasable locking mechanism.” Id. 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 Case IPR2014-00073 Patent 8,192,356 B2 12 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. In sum, for the reasons discussed, Petitioner does not persuade us by a preponderance of the evidence that claim 21 of the ’356 patent is not entitled to the benefit of the ’214 application’s filing date. To the contrary, we determine, for the reasons discussed, that the preponderance of the evidence supports a finding that claim 21 of the ’356 patent, and its dependent claims under consideration herein, claims 22, 24, 30, and 33–37, are entitled to the benefit of the June 26, 2002, filing date of the ’214 application. C. Asserted Grounds of Unpatentability 1. Obviousness Grounds Relying on Blewett In the Institution Decision, we instituted review of claims 21, 22, 24, 30, and 33–37 of the ’356 patent on two grounds that relied upon the Blewett reference, among others. Dec. 32. Petitioner asserts that “Blewett is prior art under 35 U.S.C. § 102(a) because its January 23, 2003 publication date is before the June 26, 2003 filing date of the ’362 application” to which the ’356 patent claims priority. Pet. 6. As discussed above, however, claims 21, 22, 24, 30, and 33–37 of the ’356 patent are entitled to the benefit of the June 26, 2002, filing of the ’214 Case IPR2014-00073 Patent 8,192,356 B2 13 provisional application, which is before Blewett’s January 23, 2003, publication date. Accordingly, Petitioner does not persuade us by a preponderance of the evidence that Blewett is prior art to claims 21, 22, 24, 30, and 33–37. We also are not persuaded, therefore, that Petitioner has shown by a preponderance of the evidence that claims 21, 22, 24, 30, and 33–37 of the ’356 patent are unpatentable based on the challenges which rely upon Blewett. 2. Obviousness of Claims 21, 30, 33, and 34 in view of Cistac, Obenchain, Kelleher, and Mathews a. Prior Art Evidence of Obviousness In the Institution Decision, we instituted review of claims 21, 30, 33, and 34 for obviousness in view of Cistac, Obenchain, Kelleher, and Mathews. Dec. 11–19, 32. Petitioner’s position, essentially, is that an ordinarily skilled artisan would have considered it obvious to equip the dilators and retractor blades of the surgical system described by Cistac with the nerve-monitoring electrodes taught by Kelleher. See Pet. 25–26, 30–31. Petitioner cites Obenchain as evidence that the trans-psoas path to the lumbar spine was known to be a suitable surgical approach to the lumbar spine. Id. at 34. Petitioner cites Mathews as evidence that an ordinarily skilled artisan would have considered it obvious to configure minimally invasive surgical instruments intended for lumbar spine surgery to be dimensioned so as to allow surgical implants to pass through them. Id. at 36–37. Patent Owner, in addition to the secondary considerations of nonobviousness discussed below, argues that Petitioner’s contentions regarding the prior art, as well as the testimony of Petitioner’s supporting Case IPR2014-00073 Patent 8,192,356 B2 14 witnesses, are based on improper hindsight. PO Resp. 2–3, 34–36, 39–40. Patent Owner argues also that the only motivation alleged in the Petition for combining the cited references is for using a lateral, trans-psoas path to the spine. Id. at 45. Patent Owner argues, however, that neither the cited prior art, nor the knowledge of ordinarily skilled artisans at the time of the invention, supports that rationale. Id. at 3–7, 42–46. As the Supreme Court has stated, when evaluating claims for obviousness, “the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966)). Secondary considerations, if present, also must be considered. Id. 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 Case IPR2014-00073 Patent 8,192,356 B2 15 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). Having reviewed the parties’ contentions and supporting evidence regarding the scope and content of Cistac, Obenchain, Kelleher, and Mathews, as compared to the subject matter recited in claims 21, 30, 33, and 34 of the ’356 patent, we determine that Petitioner has shown, based on the teachings in the prior art, that an ordinarily skilled artisan would have been prompted to prepare a surgical system having all of the features required by the challenged claims. Specifically, Cistac discloses that, “[t]o create a percutaneous access, as is required in a lumbar discectomy for example, it is known to insert tubular cannulas into the body and to arrange additional instruments on these by means of a positioning plate or by means of a positioning sleeve . . . .” Ex. 1002, 1:12–16. To that end, Cistac discloses a “device for creating a percutaneous access into a body, with two retractor blades which together form an access channel . . . .” Id. at 1:5–7. As seen in Figure 2 of Cistac, the two retractor blades 26 are semicircular in cross section. Id. at Fig. 2. As required by claim 21, Cistac discloses that its device includes a blade holder apparatus that releasably locks with the retractor blades. See id. at 5:31–34 (“The retractor blades can be held releasably on the carrying elements, such that it is possible for retractor blades that are suitable for the specific operation to the secured on the carrying elements.”). Case IPR2014-00073 Patent 8,192,356 B2 16 As also required by claim 21, Cistac discloses that, for initial access into the patient, its system includes an elongate penetration member, in the form of a wire, and at least two dilators of sequentially larger diameter deliverable to a spinal disc. Id. at 12. Cistac explains that, after removing the initially inserted wire and tube, the two semicircular retractor blades cooperatively “define a tubular access into the interior of the body, the size of which access can be increased by pivoting of the holding arms, for which purpose it suffices to actuate the adjusting screw 7.” Id. at 12:36–13:3, see also Fig. 2. Cistac discloses that the diameter of the retractor blades “can be of the order of 15 mm . . . .” Id. at 14:16. Although Cistac differs from claim 21 in not describing its dilators as having nerve-monitoring stimulation electrodes as recited in the claim, Kelleher discloses the desirability of including such electrodes on devices used in spinal surgery. Ex. 1003, 1. In particular, Kelleher discloses, “it 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.” Id. at 1:15–17. Kelleher also discloses that “a downside of . . . minimally invasive surgical procedures [is] that they tend to offer a somewhat reduced visibility of the patient’s tissues during the surgery. Accordingly, the danger of inadvertently contacting and/or severing a patient’s nerves can be increased.” Id. at 1:22–24. Kelleher thus discloses a nerve detection system that has “an electrode or electrodes positioned on the distal end of the surgical tool or probe, with an electromyographic system used to detect whether a spinal nerve is Case IPR2014-00073 Patent 8,192,356 B2 17 positioned adjacent to the surgical tool or probe.” Id. at 4:2–4. Kelleher explains: A conclusion is made that the surgical tool or probe is positioned adjacent to a spinal nerve when a neuro-muscular (e.g.: EMG) response to a stimulus pulse emitted by the electrode or electrodes on the surgical tool or probe is detected (at a distant myotome location, such as on the patient’s legs) at or below certain neuro-muscular response onset values (i.e.: pre-determined current intensity levels) for each of the plurality of spinal nerves. Id. at 4:4–9. Kelleher discloses that in “preferred aspects, the surgical tool or probe may be introduced into the patient in a minimally invasive cannulated approach.” Id. at 2:20–22. Kelleher further discloses that its electrified probes “can be any manner of surgical tool, including (electrified) cannulae through which other surgical tools are introduced into the patient.” Id. at 16:17–18. Given Kelleher’s teaching of the desirability of equipping surgical instruments with electrodes to detect nerves during spinal surgery when using a minimally invasive cannulated approach, we agree with Petitioner that an ordinarily skilled artisan would have been prompted to equip Cistac’s dilators with the stimulating electrode required by claim 21 of the ’356 patent, in order to allow the surgeon to detect and avoid spinal nerves when using Cistac’s cannulated surgical system. In view of Mathews’s teaching of the desirability of delivering implants through a spine-accessing minimally invasive operative corridor, see Ex. 1005, 5:50–6:16, we also agree with Petitioner that, as required by claim 21, an ordinarily skilled Case IPR2014-00073 Patent 8,192,356 B2 18 artisan would have ensured that the operative corridor created by Cistac’s system would be dimensioned to permit implant passage. As to the intended use of the system recited in claim 21, as discussed above, we attribute to the 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. Because Cistac’s instruments are sized for minimally invasive access to the lumbar spine, see Ex. 1002, 1:12–14, we are persuaded that those instruments would be capable of the intended use recited in claim 21. Moreover, although Obenchain focuses on approaches other than a trans-psoas path, see Ex. 1004, 1:48–66, Obenchain discloses, nonetheless, that minimally invasive surgery of the lumbar spine can use a trans-psoas approach: 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, or immediately in front of it. Id. at 6:22–31. In sum, given the discussed teachings of Cistac, Obenchain, Kelleher, and Mathews, Petitioner persuades us that an ordinarily skilled artisan would have been prompted to prepare a system having all of the elements of claim 21 of the ’356 patent. Patent Owner’s arguments do not persuade us to the contrary. Patent Owner advances evidence, including the testimony of Dr. Obenchain, the named inventor on the Obenchain reference, that ordinarily skilled artisans avoided traversing the psoas muscle when Case IPR2014-00073 Patent 8,192,356 B2 19 performing lumbar spinal surgery. PO Resp. 3–7 (citing Ex. 2020 ¶¶ 18–21, 36–47 (Phillips Decl.), Ex. 2025 ¶¶ 7, 13–16 (Obenchain Decl.)). As noted above, however, the psoas-traversing pathway recited in claim 21 is merely an intended use of the recited apparatus, and Patent Owner does not point with specificity to any feature in the prior art apparatuses that would have rendered them unsuitable or unusable in such an approach. Further, in light of Kelleher’s express teachings, noted above, that its nerve-sensing electrodes were generally desirable when performing spinal surgery (see Ex. 1003, 1), and were suitably deployed on any surgical instrument (id. at 16), we are not persuaded that Kelleher would have been combined with Cistac 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 Cistac’s dilators with Kelleher’s nerve-sensing electrodes, as claim 21 of the ’356 patent requires. Further, Kelleher discloses the usefulness of its electrodes in cervical and thoracic surgeries (Ex. 1003, 7, 12), as well as illustrating their use in lumbar spinal applications (id. at 12, Fig. 1), yet makes no express mention of traversing the psoas muscle in any of these contexts. We are not persuaded, therefore, that the sole reason for combining Kelleher and Cistac would have been to allow navigation of the nerve plexus in the psoas muscle, as Patent Owner contends. PO Resp. 45. In that regard, we note Case IPR2014-00073 Patent 8,192,356 B2 20 that, although Petitioner urged that the trans-psoas pathway would have provided a “particular reason” to use nerve monitoring in spinal surgery (Pet. 25), Petitioner also advanced a rationale for combining Cistac with Kelleher without reference to the trans-psoas pathway: It would have been obvious to one of ordinary skill in the art to have used nerve monitoring with the minimally invasive spinal access instruments of Cistac, such as Cistac’s dilators (sleeves). Watkins Decl., ¶ 47. As taught by Kelleher, nerve monitoring would have warned the user if the dilators moved close to a nerve. Id. In sum, having considered the prior art advanced by Petitioner in light of Patent Owner’s arguments regarding the cited references’ teachings, Petitioner persuades us, based on the teachings in those references, that an ordinarily skilled artisan would have been prompted to prepare a system having all of the elements of claim 21 of the ’356 patent. As to claim 21’s dependent claims 30, 33, and 34, Patent Owner does not direct us to any deficiency in Petitioner’s contentions that the teachings in Cistac, Obenchain, Kelleher, and Mathews would have suggested a system having the additional features recited in those claims. We have analyzed Petitioner’s evidence regarding those references as compared to claims 30, 33, and 34 (see Pet. 30–31, 38–39), and agree, based on this evidence, that the prior art teaches each limitation of those claims. Petitioner persuades us further that, based on the references’ teachings, an ordinarily skilled artisan would have been prompted to prepare a system having all of the elements required by those claims. Case IPR2014-00073 Patent 8,192,356 B2 21 b. Secondary Considerations/Objective Indicia Patent Owner contends that objective evidence shows that the claimed surgical system would not have been obvious to an ordinarily skilled artisan. PO Resp. 7–9. In particular, Patent Owner contends that its surgical system solved a long-felt need (id. at 9–14), overcame significant skepticism (id. at 14–16), elicited significant praise and recognition among practitioners in the art as being advantageous as compared to other lumbar surgical techniques (id. at 16–26), experienced significant commercial success (id. at 26–31), and was copied by competitors (id. at 31–34). Petitioner replies that Patent Owner has failed to establish adequately a nexus between the objective indicia advanced by Patent Owner and the subject matter recited in the claims. Reply 1, 7–11. Moreover, Petitioner argues, the guidance along a trans-psoas pathway, upon which Patent Owner bases its contentions regarding the objective indicia, is not a required element of the challenged claims, which are directed to apparatuses. Id. at 2–3, 9. Before we conclude whether the challenged claims would have been obvious, in addition to the teachings in the prior art, “[s]uch secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented.” Graham, 383 U.S. at 17–18. Such objective indicia of nonobviousness must be considered “as part of all the evidence, not just when the decision maker remains in doubt after reviewing the art.” Eurand, Inc. v. Mylan Pharm. Inc. (In re Cyclobenzaprine Hydrochloride Extended–Release Capsule Patent Litig.), 676 F.3d 1063, 1076–77 (Fed. Cir. 2012) (citation omitted). Case IPR2014-00073 Patent 8,192,356 B2 22 Although Petitioner bears the ultimate burden of persuasion under 35 U.S.C. § 316(e), “[f]or objective evidence to be accorded substantial weight, its proponent [Patent Owner] must establish a nexus between the evidence and the merits of the claimed invention.” In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). In particular, the objective indicia “must be tied to the novel elements of the claim at issue” and must “‘be reasonably commensurate with the scope of the claims.’” Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013) (quoting Rambus Inc. v. Rea, 731 F.3d 1248, 1257 (Fed. Cir. 2013)). In the instant case, Petitioner persuades us that the evidence of secondary considerations is not entitled to substantial weight, because Patent Owner has not established a sufficient nexus between the claimed subject matter and that evidence. Petitioner persuades us also that the evidence of secondary considerations is not reasonably commensurate in scope with the claimed subject matter. In asserting that the claimed surgical system solved a long-felt need, Patent Owner focuses its contentions on the alleged need for a lateral, trans- psoas pathway. PO Resp. 9–12. Similarly, in its contentions regarding initial skepticism, the evidence advanced by Patent Owner is directed to the contention that ordinarily skilled practitioners did not believe that the lumbar spine could be accessed safely using the lateral trans-psoas approach. Id. at 14–16 (citing Ex. 2020 ¶¶ 28–33 (Phillips Decl.), Ex. 2024 ¶¶ 12–15 (Miles Decl.), Ex. 2025 ¶¶ 14–15, 21 (Obenchain Decl.)). As noted above, however, the recitations in claim 21 regarding the lateral, trans-psoas pathway relate only to the intended use of the claimed apparatus, and do not require the apparatus to be used in that fashion. Indeed, the ’356 patent Case IPR2014-00073 Patent 8,192,356 B2 23 acknowledges that, rather than being limited or unique to the lateral trans- psoas intended use, “the access system of the present invention is suitable for use in any number of additional surgical procedures, including those wherein tissue having significant neural structures must be passed.” Ex. 1018, 3:19–21. Moreover, even if practitioners preferred anterior or posterior approaches to the lumbar spine rather than a lateral psoas-traversing approach (PO Resp. 9–11), that does not persuade us that there existed a long-felt but unresolved need for the lateral trans-psoas pathway. To the contrary, 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 resolved. That those alternative approaches 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. 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); see also 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.”). In the instant case, although Patent Owner directs us to evidence that practitioners attempted to develop a lateral trans-psoas approach, Patent Owner concedes that those efforts were not widespread, but instead involved no more than “a small handful of patients.” PO Resp. 12. Case IPR2014-00073 Patent 8,192,356 B2 24 Patent Owner focuses on its “XLIF” (“eXtreme Lateral Interbody Fusion”) system, in contending that the claimed surgical system allowed surgeons to traverse the psoas muscle safely and reproducibly in order to access the lumbar spine. PO Resp. 1, 12–14. The “XLIF procedure and systems” are described in Exhibit 2028. Id. at 13. Patent Owner contends that Dr. Phillips— “a board certified orthopaedic surgeon—compared XLIF to the independent claims of the ’356 patent . . . [and] concluded that the XLIF procedure and systems embody at least the independent claims of the ’356 patent.” Id. at 14 (citing Ex. 2020 ¶¶ 22–23, 27, Attachment C (Phillips Decl.)). We acknowledge that Dr. Phillips’s Declaration includes a chart mapping the features of claim 21 of the ’356 patent to various disclosures in Exhibit 2028. See Ex. 2020, 139–147 (Attachment C). None of this explanation appears in Patent Owner’s Response, however. Nor does Patent Owner’s Response include any other specific discussion of how the features of XLIF correspond to the limitations in claim 21, or any of the other challenged claims. Accordingly, we conclude that Patent Owner’s Response improperly incorporates by reference these arguments from the Phillips Declaration into the Response. See 37 C.F.R. § 42.6(a)(3) (“Arguments must not be incorporated by reference from one document into another document.”). Even disregarding the procedural infirmities in Patent Owner’s Response, Petitioner persuades us, nonetheless, that Patent Owner has not established a sufficient nexus between the claimed subject matter and the objective evidence of nonobviousness. Specifically, Patent Owner’s evidence of industry praise, as well as improved patient outcomes, focuses Case IPR2014-00073 Patent 8,192,356 B2 25 on the use of the XLIF technique in a lateral trans-psoas approach. PO Resp. 16–26. As noted above, however, because it is directed to an apparatus, claim 21 simply does not require using that approach. Moreover, as Petitioner argues (Reply 7–10), Patent Owner acknowledges that a key aspect to the acceptability of the XLIF technique was its nerve monitoring system, which allowed safe navigation of the psoas. See PO Resp. 17 (“[T]he NeuroVision nerve monitoring system . . . along with [Patent Owner] NuVasive’s techniques and other instruments, were the linchpin to safety and reproducibility.”), id. at 18 (“XLIF . . . uses real-time directional neuromonitoring to ensure a safe passage through the psoas muscle, avoiding the nerves of the lumbar plexus.”) (emphasis removed), id. at 19 (“It is safe and reproducible with few complications due to the use of automated neuromonitoring (NeuroVision®).”) (emphasis removed), id. at 20 (“Dynamic, discrete-threshold EMG is an integral and necessary part of the XLIF procedure.”) (emphasis removed). Patent Owner acknowledges also that the XLIF system includes three dilators, each of which includes a stimulation electrode. Ex. 2020, 142 (Phillips Decl., Attachment C). In contrast, claim 21 does not require real-time, directional, or automated nerve monitoring. Ex. 1018, 18:60–19:24. Rather, as to nerve monitoring, the system of claim 21 merely includes two dilators, only one of which must have a stimulation electrode for nerve monitoring. Id. at 19:6– 10. Accordingly, Petitioner persuades us that the XLIF system includes a number of important features, which Patent Owner concedes contribute significantly to any praise that may have been elicited, but which are not recited in claim 21. Petitioner persuades us also, therefore, that Patent Case IPR2014-00073 Patent 8,192,356 B2 26 Owner has not established a nexus between the features of the XLIF system that are asserted to have elicited praise, and the sole claim for which Patent Owner presents specific argument as to secondary considerations. See Ex. 2020, 139–147 (Phillips Decl. Attachment C) (comparing XLIF (Ex. 2028) to claim 21 of the ’356 patent). As to commercial success, Patent Owner contends that the growth in its revenue, from about $38 million in 2004 to about $685 million in 2013, is a direct result of XLIF, which was introduced in 2003. PO Resp. 27–28. Patent Owner contends that XLIF created the lateral spine fusion market, which it held exclusively until Petitioner’s entry into the market in 2006. Id. To support its contentions regarding commercial success, Patent Owner relies (PO Resp. 28–30) on the Declaration of its company executive Patrick Miles (Ex. 2024 ¶ 1), its own internal report (Ex. 2040), as well as market research reports from financial analysts (Ex. 2041 (www.idataresearch.net)); Ex. 2056 (J.P. Morgan); Ex. 2058 (Canaccord Genuity); Ex. 2059 (Caris & Co)). Patent Owner summarizes its commercial success contentions as follows: As the evidence shows, XLIF’s commercial success (and by extension NuVasive’s) is a direct result of the novel combination of the minimally invasive nerve monitoring enabled distractor(s)/dilator(s) and working corridor instrument (retractor) (also optionally nerve monitoring enabled) with NuVasive’s nerve monitoring system to safely and reproducibly perform a lateral transpsoas approach to the lumbar spine as claimed by the ’356 patent. . . . Not only is this technology key to XLIF, but it is key to creating an entirely new market for fusion. Case IPR2014-00073 Patent 8,192,356 B2 27 PO Resp. 30–31 (citing Ex. 2024 ¶¶ 24–29 (Miles Decl.)). Petitioner persuades us (Reply 4, 7–11), that Patent Owner has not explained with adequate specificity the nexus between its assertions of commercial success and the claimed subject matter. Similar to the discussion above, Patent Owner acknowledges that the nerve monitoring techniques employed in the XLIF system are critical to the asserted commercial success of the system. See PO Resp. 28 (XLIF “makes use of NuVasive’s proprietary NeuroVision neuromonitoring software to protect nerve bodies”) (citing Ex. 2041), id. at 29 (navigating around key nerves facilitated “through a proprietary technology (the foundation of the company, in fact) called NeuroVision”) (citing Ex. 2056 (emphasis removed)), id. at 30 (“The critical component obviously lies within its NeuroVision offering and its MaXcess retractor system.”) (citing Ex. 2058 (emphasis removed), id. (“Despite the obvious advantages of the lateral approach, it requires that the surgeon avoid the nerve roots on the spine, which wasn’t practical until NUVA [Patent Owner] launched its Inter- operative Nerve monitoring system.”) (emphasis removed). Thus, although Patent Owner acknowledges that XLIF includes certain features that are critical to its success, including a software-driven nerve monitoring system and the use of the trans-psoas pathway, those features are either not recited in, or not required by, claim 21. As to the remaining claims under challenge, Patent Owner does not present any specific argument explaining how the features of those claims correspond to the elements of the XLIF system. In addition, Petitioner directs us to evidence supporting its contention that the commercial success asserted by Patent Owner resulted, at least in Case IPR2014-00073 Patent 8,192,356 B2 28 part, from factors not associated with either the claims under challenge or the techniques or hardware of XLIF. Specifically, as Petitioner points out (Reply 1), a Form 10-K filed by Patent Owner with the United States Securities and Exchange Commission for the fiscal year ending December 31, 2013, states the following: To date, the majority of our revenues have been derived from the sale of implants, biologics and disposables, and we expect this trend to continue for the foreseeable future. We generally loan our proprietary software-driven nerve monitoring systems and surgical instrument sets at no cost to surgeons and hospitals that purchase disposables and implants for use in individual procedures. In addition, we place our proprietary software-driven nerve monitoring systems, MaXcess® and other MAS or cervical surgical instrument sets with hospitals for an extended period at no up-front cost to them. Ex. 2038, 69 (10-K filing by Patent Owner). As the Federal Circuit has explained, “evidence of commercial success alone is not sufficient to demonstrate nonobviousness of a claimed invention.” In re DBC, 545 F.3d 1373, 1384 (Fed. Cir. 2008). Instead, “the proponent must offer proof ‘that the sales were a direct result of the unique characteristics of the claimed invention-as opposed to other economic and commercial factors unrelated to the quality of the patented subject matter.’” Id. (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Here, Patent Owner acknowledges that the majority of its revenue had come from sales of implants, biologics, and disposables, but does not explain persuasively how this is consistent with its contention that its commercial success resulted directly from the elements of the XLIF system included within claim 21 of the ’356 patent. Also, Petitioner’s contention, Case IPR2014-00073 Patent 8,192,356 B2 29 that the success asserted by Patent Owner was attributable to factors unrelated to the features of the claimed invention, is supported by the fact that Patent Owner loaned its proprietary software-driven nerve monitoring systems and surgical instruments at no cost to surgeons and hospitals that purchased its disposables and implants. In sum, for the reasons provided, Petitioner persuades us that Patent Owner has not explained with adequate specificity the nexus between its evidence of commercial success and the subject matter recited in claim 21 and its dependents. As to Patent Owner’s contentions regarding copying, we find that Petitioner has the better position as well. The Federal Circuit has explained that “[n]ot every competing product that arguably falls within the scope of a patent is evidence of copying; otherwise, ‘every infringement suit would automatically confirm the nonobviousness of the patent.’” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010) (quoting Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d at 1325). Rather, copying requires evidence of efforts to replicate a specific product, which may be demonstrated through internal company documents, direct evidence such as disassembling a patented prototype, photographing its features, and using the photograph as a blueprint to build a replica, or access to the patented product combined with substantial similarity to the patented product. Id. In the instant case, Patent Owner directs us to a 2004 internal document from Petitioner discussing XLIF’s direct lateral trans-psoas approach, including its NeuroVision nerve monitoring system. PO Case IPR2014-00073 Patent 8,192,356 B2 30 Resp. 32–33 (citing Ex. 2086, 1, 3). Patent Owner asserts that Petitioner subsequently introduced its own version of the XLIF system, “DLIF,” in 2006. Id. at 33. Patent Owner cites the following passage from a 2011 Caris & Company financial analysis report to show that DLIF system included the features of the challenged claims of the ’356 patent: [Petitioner] MDT which is the dominant player in spine (just under 40% market share) has offered its version of XLIF, DLIF (Direct Lateral Interbody Fusion) for the past 3 years, and it struggled to gain footing against XLIF. Part of the problem was the lack [of] integration of a neuro monitoring system, but they are addressing now with a newly integrated system, though our checks still indicate that it’s not quite on par with [Patent Owner] NUVA offerings, it is competitive. Id. (quoting Ex. 2059, 4). Although this evidence suggests that DLIF may have a nerve monitoring system similar to XLIF, Patent Owner does not direct us to any evidence that describes the specific components of the DLIF system, nor does Patent Owner otherwise explain with specificity why the particular features required by claim 21, or any of the other challenged claims of the ’356 patent, are in the DLIF system. Patent Owner cites the following passage from a 2008 J.P. Morgan financial analysis report to show that other competitors also copied Patent Owner’s XLIF system: “[n]early every competitor now offers a lateral access and/or neuromonitoring system and while [Patent Owner] NuVasive can lay claim to the superiority of Nuerovision [sic] and the sophistication and experience of XLIF, Medtronic, Globus, Depuy, and others are all fighting back.” PO Resp. 33 (quoting Ex. 2066, 1) (emphasis removed). Again, however, although this evidence suggests that Patent Owner’s competitors may have had nerve monitoring systems similar to XLIF, Patent Case IPR2014-00073 Patent 8,192,356 B2 31 Owner does not direct us to any evidence that describes the specific components of its competitors’ systems, nor does Patent Owner otherwise explain with specificity why the particular features required by the claim 21, or any of the other challenged claims of the ’356 patent, are in its competitors’ systems. Accordingly, in the absence of evidence credibly demonstrating that the products of Petitioner and other competitors of Patent Owner include the features required by the challenged claims of the ’356 patent, we are not persuaded that Patent Owner has provided an adequate basis to find that Petitioner or Patent Owner’s other competitors copied the apparatuses recited in the challenged claims. c. Conclusion of Obviousness In sum, as discussed above, having considered the prior art advanced by Petitioner in light of Patent Owner’s arguments regarding the cited references’ teachings, Petitioner persuades us, based on the teachings in Cistac, Obenchain, Kelleher, and Mathews, that an ordinarily skilled artisan would have been prompted to prepare a system having all of the elements of claims 21, 30, 33, and 34 of the ’356 patent. As also discussed above, having considered Patent Owner’s evidence and arguments regarding objective indicia of nonobviousness, Petitioner persuades us that Patent Owner’s evidence does not show a sufficient nexus between the claimed subject matter and the objective indicia. Accordingly, under these circumstances, taking into consideration the record as a whole, we conclude that Petitioner has shown by a preponderance of the evidence that an ordinarily skilled artisan would have considered the surgical systems recited Case IPR2014-00073 Patent 8,192,356 B2 32 in claims 21, 30, 33, and 34 of the ’356 patent obvious in view of Cistac, Obenchain, Kelleher, and Mathews. 3. Remaining Grounds In the Institution Decision, in addition to the grounds discussed above, we instituted review of (1) claims 22 and 24 for obviousness over Cistac, Obenchain, Kelleher, Mathews, and Koros; (2) claim 35 for obviousness over Cistac, Obenchain, Kelleher, Mathews, and NIM Guide; and (3) claims 36 and 37 for obviousness over Cistac, Obenchain, Kelleher, Mathews, NIM Guide, and Jones. Dec. 32. Each of claims 22, 24, and 35–37 depends directly or ultimately from claim 21, and adds additional features to the system recited in claim 21. Ex. 1018, 19:25–20:46. Petitioner cited the Koros, NIM Guide, and Jones references to show that an ordinarily skilled artisan would have considered those features obvious components of the system suggested by Cistac, Obenchain, Kelleher, and Mathews. Pet. 27– 29, 31–33, 37–38, 39–41. We have considered that evidence, and agree that the prior art teaches the remaining limitations of claims 22, 24, and 35–37. Other than the arguments addressed above, Patent Owner does not assert specifically any defect in Petitioner’s assertions or findings as to those grounds or references, nor does Patent Owner assert any defect or deficiency in our analysis of those grounds in the Institution Decision. See PO Resp. 57–58. 3 Accordingly, for the reasons discussed above, we conclude that 3 Patent Owner seeks to incorporate by reference the arguments made in its Preliminary Response into its Response. PO Resp. 57–58. As noted above, however, “[a]rguments must not be incorporated by reference from one document into another document.” 37 C.F.R. § 42.6(a)(3). Case IPR2014-00073 Patent 8,192,356 B2 33 Petitioner has shown by a preponderance of the evidence that claims 22, 24, and 35–37 would have been obvious to an ordinarily skilled artisan at the time the claimed subject matter was invented. 4. Petitioner’s Motion to Exclude Evidence Petitioner moves to exclude as hearsay Exhibits 2033, 2035, and 2036, which are asserted to be printouts from websites of Dr. Burak Ozgur and Dr. Jonathan R. Stieber, because neither Dr. Ozgur nor Dr. Stieber provided testimony in this proceeding, and because Patent Owner’s attorney admitted not knowing the doctors, but instead merely printed the exhibits from the internet. Mot. to Exclude 1–2. Patent Owner contends that Exhibits 2033, 2035, and 2036 are presented for non-hearsay purposes, to show what was being said about XLIF as praise and recognition by the industry, rather than the truth of the matter asserted. PO Opp. 2–3. We agree that Exhibits 2033, 2035, and 2036 are offered for non- hearsay purposes. Therefore, we do not exclude them. Petitioner moves to exclude as hearsay Exhibits 2039, 2041, 2056, 2058, 2059, and 2066, which are asserted to be financial industry documents evidencing commercial success and praise. Mot. to Exclude 3. Petitioner contends that these exhibits are not reliable because Patent Owner has admitted that it has no knowledge of whether the authors of the documents are skilled artisans. Mot. to Exclude 3–4. Patent Owner argues that these documents are introduced for non- hearsay purposes, such as showing industry praise and the states of mind of the documents’ authors, and that the credentials of the authors go to the weight of the evidence, not its admissibility. PO Opp. 6–7. Case IPR2014-00073 Patent 8,192,356 B2 34 We agree with Patent Owner that the Exhibits were presented for non- hearsay purposes, and that the credentials of the authors go to the weight of the evidence, not its admissibility. Accordingly, we deny the motion to exclude Exhibits 2039, 2041, 2056, 2058, 2059, and 2066. We dismiss Petitioner’s Motion to Exclude Exhibits 2034, 2042, 2051, 2062, and 2070–73 as moot, because we do not rely on those Exhibits. III. CONCLUSION For the reasons given, we are persuaded that Petitioner has shown by a preponderance of the evidence that claims 21, 22, 24, 30, and 33–37 of the ’356 patent are unpatentable based on the following grounds of unpatentability: (1) Claims 21, 30, 33, and 34 under 35 U.S.C. § 103(a) as obvious over Cistac, Obenchain, Kelleher, and Mathews; (2) Claims 22 and 24 under 35 U.S.C. § 103(a) as obvious over Cistac, Obenchain, Kelleher, Mathews, and Koros; (3) Claim 35 under 35 U.S.C. § 103(a) as obvious over Cistac, Obenchain, Kelleher, Mathews, and NIM Guide; (4) Claims 36 and 37 under 35 U.S.C. § 103(a) as obvious over Cistac, Obenchain, Kelleher, Mathews, NIM Guide, and Jones. For the reasons given, we are not persuaded that Petitioner has shown by a preponderance of the evidence that claims 21, 22, 24, 30, and 33–37 of the ’356 patent are unpatentable based on the following grounds of unpatentability: (5) Claims 21, 30, and 33–37 under 35 U.S.C. § 103(a) as obvious over Branch, Obenchain, Blewett, and Onimus; and Case IPR2014-00073 Patent 8,192,356 B2 35 (6) Claims 22 and 24 under 35 U.S.C. § 103(a) as obvious over Branch, Blewett, Obenchain, Onimus, and Koros. IV. ORDER It is ORDERED that claims 21, 22, 24, 30, and 33–37 of the ’356 patent have been shown by a preponderance of the evidence to be unpatentable; FURTHER ORDERED that Petitioner’s Motion to Exclude is denied- in-part, and dismissed-in-part as moot; and FURTHER ORDERED that, because this is a final written decision, parties to this proceeding seeking judicial review of our Decision must comply with the notice and service requirements of 37 C.F.R. § 90.2. Case IPR2014-00073 Patent 8,192,356 B2 36 For PETITIONER: Brian L. Klock Justin J. Oliver FITZPATRICK, CELLA, HARPER & SCINTO SPINE-IPR@fchs.com For PATENT OWNER: Michael T. Rosato Paul D. Tripodi II WILSON SONSINI GOODRICH & ROSATI MROSATO@WSGR.COM PTRIPODI@WSGR.COM Stephen R. Schaefer Michael T. Hawkins FISH & RICHARDSON P.C. SCHAEFER@FR.COM HAWKINS@FR.COM IPR13958-0120IP1@FR.COM Copy with citationCopy as parenthetical citation