Ex Parte 7691057 et alDownload PDFPatent Trial and Appeal BoardJun 30, 201495001888 (P.T.A.B. Jun. 30, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 95/001,888 02/09/2012 7691057 20330.0002.RX057 7222 26191 7590 07/01/2014 FISH & RICHARDSON P.C. (TC) PO BOX 1022 MINNEAPOLIS, MN 55440-1022 EXAMINER FLANAGAN, BEVERLY MEINDL ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 07/01/2014 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ GLOBUS MEDICAL, INC. Requester and Appellant v. NUVASIVE, INC. Patent Owner and Respondent ____________ Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 Technology Center 3900 ____________ Before DANIEL S. SONG, RAE LYNN P. GUEST, and BRETT C. MARTIN, Administrative Patent Judges. GUEST, Administrative Patent Judge. DECISION ON APPEAL Third Party Requester, Globus Medical, Inc. (âRequesterâ) appeals under 35 U.S.C. §§ 134(c) and 315(b) the Examinerâs decision not to reject claims 17-22 and 24-27. 1 We have jurisdiction under 35 U.S.C. §§ 134(c) and 315(b). 1 See Requesterâs Appeal Brief 1-2 (filed January 16, 2013) (hereinafter âReq. App. Br.â); Examinerâs Answer (mailed March 29, 2013), Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 2 We heard oral arguments from Requester and Patent Owner on April 30, 2014, a written transcript of which will be entered into the electronic record in due course. STATEMENT OF THE CASE United States Patent 7,691,057 B2 (hereinafter the ââ057 patentâ), which is the subject of the current inter partes reexamination, issued to Patrick Miles, et al. on April 6, 2010. The â057 patent is related to U.S. Patent 7,582,058, which is the subject of Reexamination Control 95/001,247, in which a final decision on appeal was entered April 15, 2014. The â057 patent is also related to U.S. Patent 7,819,801, which is the subject of Reexamination Control 95/001,889, currently on appeal and heard on April 30, 2014 along with this reexamination. The â057 patent is also related to U.S. Patent 7,905,840 and U.S. Patent 7,207,949, which are the subjects of Reexamination Control 95/001,890 and 95/001,202, respectively, also currently on appeal. The â057 patent is the subject of a currently pending litigation in the U.S. District Court for the District of Delaware styled NuVasive, Inc. v. Globus Medical, Inc., Case No. 1:10-cv-00849. Patent Owner, NuVasive, Inc. 2 (hereinafter âPatent Ownerâ) filed a Respondent Brief in this appeal. incorporating by reference the Examinerâs Right of Appeal Notice (mailed October 16, 2012) 1 and 5 (hereinafter âRAN.â). 2 See Patent Owner Respondent Brief 1 (filed February 19, 2013) (hereinafter âPO Res. Br.â). Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 3 The â057 patent relates to a system and method for accessing a surgical target site, particularly for use in surgical procedures wherein tissue having significant neural structures must be passed through or near, such as spinal surgery. â057 patent, Abstract and col. 2, ll. 61-64. Claim 17 is the sole independent claim on appeal and was not amended during reexamination. Claims 17 reads as follows: 1. A method of accessing a surgical target site within a spine, comprising the steps of: (a) creating a distraction corridor along a lateral, trans- psoas path to a targeted lumbar spinal disc in a lumbar spine using a distraction assembly comprising at least two dilators that are sequentially inserted along the lateral, trans-psoas path to the targeted lumbar spinal disc; (b) slidably advancing plurality of retractor blades of a retraction assembly along an outermost dilator of the at least two dilators of the distraction assembly, the retraction assembly comprising a handle assembly coupled to the plurality of retractor blades such that the retractor blades extend generally perpendicularly relative to arm portions of the handle assembly, each of said plurality of retractor blades having a generally concave inner face and a generally convex exterior face, said handle assembly being capable of moving said plurality of retractor blades from a closed position to an open position, said closed position being characterized by said plurality of retractor blades being positioned to abut one another and form a closed perimeter, said open position characterized by said plurality of retractor blades being positioned generally away from one another and forming an open perimeter; (c) simultaneously introducing said plurality of retractor blades over the outermost dilator of said distraction assembly along the lateral, trans-psoas path to the targeted lumbar spinal disc while in said closed position; Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 4 (d) actuating said handle assembly to move said plurality of retractor blades to the open position so that the plurality of retractor blades create an operative corridor along the lateral, trans-psoas path to the targeted lumbar spinal disc; (e) releasably engaging a fixation element with at least one of the plurality of retractor blades so that a distal portion of the fixation element extends distally from the at least one retractor blade and penetrates into a lateral aspect of the lumbar spine, wherein the fixation element secures the at least one retractor blade to the lumbar spine; (f) inserting an implant through the operative corridor created by the plurality of retractor blades along the lateral, trans-psoas path to the targeted lumbar spinal disc. (Req. App. Br. 20, Claims Appâx.) Requester appeals the Examinerâs decision not to reject the claims as follows: I. claims 17, 18, and 24 as rendered obvious by Branch3 in view of Kossmann, 4 and Koros 5 (Ground 1; RAN 2); II. claims 19-22 as rendered obvious by Branch in view of Kossmann, Koros, and Kelleher 6 (Ground 2; RAN 2); III. claim 25 as rendered obvious by Branch in view of Kossmann, Koros, and Michelson 7 (Ground 3; RAN 2); 3 US 6,945,933 B2, issued September 20, 2005 to Charles L. Branch et al. 4 Thomas Kossmann, et al., âMinimally Invasive Vertebral Replacement with Cages in Thoracic and Lumbar Spine,â European J. of Trauma, 27(6):292-300 (2001). 5 US 5,928,139, issued July 27, 1999 to Tibor B. Koros, et al. 6 WO 01/37728 A1, published May 31, 2001 and naming Brian S. Kelleher, et al. as inventors. 7 US 5,772,661, issued June 30, 1998 to Gary Karlin Michelson. Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 5 IV. claim 26 as rendered obvious by Branch in view of Kossmann, Koros, and Tsou 8 (Ground 4; RAN 2); V. claim 27 as rendered obvious by Branch in view of Kossmann, Koros, Tsou, and Kelleher (Ground 5, RAN 2). The Requester relies on the Declaration of Isador H. Lieberman executed July 5, 2012 and attached exhibits (Appendix 1, App. Br. 22, Evidence Appâx) (hereinafter âLieberman Declarationâ or âLieberman Decl.â). Patent Owner relies on the Declaration of Jim Youssef executed June 4, 2012 (Appendix 2, App. Br. 22, Evidence Appâx; PO Res. Br. 16, Evidence Appâx) (hereinafter âYoussef Declarationâ or âYoussef Decl.â). PROPOSED REJECTIONS 1 and 4 Branch, Kossmann, and Koros Claims 17, 18, 24, and 26 The Proposed Rejection Requester contends that Branch teaches a method for accessing a surgical target site within a spine having most of the steps recited in claim 17. Request for Inter Partes Reexamination (filed February 9, 2012) (hereinafter âRequestâ) 16-19 and 26-35; Req. App. Br. 6-7. The method taught by Branch is described for use in different surgical approaches including a âlateral, postero-lateral, and/or antero-lateral approaches.â 8 US 2002/0077632 A1, published June 20, 2002 and naming Paul M. Tsou as the sole inventor. Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 6 Branch, col. 2, ll. 32-51. Requester acknowledges that Branchâs method is not specifically described for use in a lateral, trans-psoas path as recited in claim 17 (Request 27; Req. App. Br. 6) and that Branch does not specifically describe releasably engaging a fixing element as recited in element (e) of claim 17. Kossmann discloses Splitting of the psoas muscle along its fibers had to be done in some very athletic patients, since the excessive size of the muscle did not allow a direct lateral access to the vertebra. During blunt dissection, care was taken to preserve the iliohypogastric/ilioinguinal nerves which may cross the surgical field. Kossmann, p. 296, col. 1, first ¶. Requester contends that â[a]s described in Kossmann, one type of surgical procedure to access a spinal disc is via a lateral, trans-psoas path and one of ordinary skill in the art would be motivated to create a lateral, trans-psoas path to a targeted lumbar spinal disc using well-known tissue dilators and retractors as disclosed in Branch.â Req. App. Br. 8-9. Requester contends that âBranch in view of Koros provides for fixation elements releasably engaged with at least of a plurality of retractor blades so that a distal portion of the fixation element extends distally from the at least one retractor blade and penetrates into a lateral aspect of the lumbar spine, wherein the fixation element secures the at least one retractor blade to the lumbar spine.â Request 34. Issues The issues for this rejection are: By preponderance of the evidence, would it have been obvious to one of ordinary skill in the art to have used the method of Branch in not only a Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 7 lateral approach to the spine as described in Branch, but in âa lateral, trans- psoas path to a targeted lumbar spinal disc in a lumbar spineâ as described in Kossmann? By preponderance of the evidence, would it have been obvious to one of ordinary skill in the art to have modified the method of Branch to include a step of releasably engaging a fixation element with a retractor blade to secure the retractor blade to the spine, as described in Koros? Discussion Patent Owner contends that Kossmannâs âblunt dissectionâ of the psoas muscle would not have been done by a dilator and retraction blades, but would only be safely done by a surgeonâs finger or blunt instrument. PO Res. Br. 6-8. In support of this argument, Patent Owner relies on the testimony of Dr. Youssef, who opines that the âblunt dissectionâ described in Kossmann is not equivalent to dilation and retraction and that Kossmann does not disclose that dilation and retraction can be safely done. Id.; see Youssef Decl. ¶ 14. Relying on this argument, the Examiner agreed with Patent Owner and determined that â[t]he Lieberman declaration does not lift the Kossman [sic] declaration to the level of teaching a lateral trans-psoas approach using the dilators and multi-blade retractor of Branch.â RAN 4. The Examiner was also persuaded by Patent Ownerâs argument regarding the limited disclosure of a trans-psoas approach in Kossmann for âsome very athletic patientsâ where the general approach was to move aside the psoas muscle rather than transversing the psoas muscle. See RAN 4, PO Res. Br. 7-8; Kossmann, p. 296, col. 1, first ¶. Patent Owner further contends that there was skepticism in the art that a lateral, trans-psoas approach could be Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 8 done safely and effectively. PO Res. Br. 8 (citing Youssef Decl. ¶ 7 and In re Brimonidine Patent Litigation, 643 F.3d 1366, 1374 (Fed. Cir. 2011)). We are not persuaded by Patent Ownerâs arguments and determine that the Examiner erred in concluding that one of ordinary skill in the art would not have considered the use of a dilator, as taught by Branch, to be an alternative âblunt instrumentâ suitable for use in a âblunt dissectionâ of the psoas muscle. Kossmann describes the blunt dissection as being performed âeither by finger or with a wet sponge mounted on a stick.â Kossmann, p. 296, col. 1, first ¶. Kossmann further describes the use of âretractors . . . placed onto the table-fixed SynFrame . . . and adjusted to the needs of the surgeons.â Id. at p. 295, col. 1, last ¶. Dr. Youssef describes âblunt dissectionâ as being âmost safely achieved with the use of the surgeonâs fingers or a blunt instrument.â Youssef Decl. ¶ 14. While Dr. Youssef states that such a âblunt dissectionâ is ânot equivalent to dilation and retractionâ and âwould not have been accomplished with the use of dilators and retractionâ (id.), Dr. Youssef has not identified any structural characteristics of a dilator, such as that taught by Branch, that would distinguish it from any other âblunt instrumentâ that might be used, particularly when a dilator is similarly used to create a pathway through tissue. For example, Branch states that skin 60 and tissue 68 can be sequentially dilated via dilation instrument set 66 which can include guidewires and/or one or more tissue dilators of increasing size. The tissue dilators are inserted one over another to form a pathway 62 through skin 60 and tissue 68 to the surgical site in the patient. In such procedures, retractor 20 is positioned over the last inserted dilator to form pathway 62 in the skin and tissue. Working channel 50 through retractor 20 provides access to a working Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 9 space 64 at the distal end of retractor 20 when the guidewires and dilators, if used, are removed therefrom. Branch, col. 6, ll. 48-58. Thus, Branch evinces that a dilator is an alternative âblunt instrumentâ that would appear to provide a more precise and gradually increasing pathway as compared to a surgeonâs finger or wet sponge on a stick, as taught by Kossmann. Accordingly, we find Dr. Youssefâs testimony, that a dilator is not a âblunt instrumentâ and would not be considered by a skilled artisan, to be unsupported by an underlying factual basis and at odds with the discussion in Branch of how a dilator works. Further, Dr. Youssef has not fully explained why a dilator and retractor device would inherently be considered a less safe means for dissection than a surgeonâs finger or wet sponge on a stick. Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (âNothing in the rules or in our jurisprudence requires the fact finder to credit the unsupported assertions of an expert witness.â). Instead, the dilator discussion in Branch is more consistent with the testimony of Dr. Lieberman that â[t]he use of instruments such as dilation and retraction assemblies is no more invasive than the use of blunt dissection, both techniques do the exact same thing for the exact same purpose.â Lieberman Decl. ¶ 21. We are also not persuaded by the limited use of a trans-psoas approach in Kossmann for only âvery athletic patients.â â[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.â KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). The problem of providing a lateral approach in âvery athletic Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 10 patientsâ is a reason that the skilled artisan would have used a lateral trans- psoas approach as taught by Kossmann. No more analysis is needed to reach a conclusion that a lateral, trans-psoas approach would have been obvious for the skilled artisan when performing spinal surgery on a very athletic patient. We are further unpersuaded by Dr. Youssefâs testimony that spinal surgeons were skeptical that a lateral, trans-psoas approach could be done safely. Youssef Decl. ¶ 7. Dr. Youssefâs testimony refers to his personal skepticism and lacks any supporting evidence of what the spinal surgeon community as a whole would have regarded as a safe approach at the time of the invention. Moreover, considering that Kossmann was actually performing such an approach for âvery athletic patientsâ when alternative approaches were not possible, appears to weigh against the assertion that such skepticism was widely held by spinal surgeons at the time of the invention. Accordingly, we disagree with the Examinerâs determination and conclude that, based on a preponderance of the evidence, it would have been obvious for one of ordinary skill in the art to create a distraction corridor along a lateral, trans-psoas path in very athletic patients, as taught by Kossmann, using a dilator and retractor assembly of the type taught by Branch as an alternative âblunt instrumentâ to a surgeonâs finger or wet sponge on a stick. Patent Owner further contends that one of ordinary skill in the art would not have combined Korosâ âscrew fixation mechanismâ with the Branch retractor because Korosâ âtubular guides 86â positioned on Branchâs Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 11 access system would result in âretractor blades having inner convex bulges, not a generally concave face as claimed.â PO Res. Br. 9. According to Patent Owner, âthe inclusion of the tubular guides 86 in the Branch retractor blades would prevent the blades from being put in a closed position . . . or would require that the retractor be made much larger.â Id. at 10-11 (citing Youssef Decl. ¶ 10). Further, Patent Owner contends that the tubular guides 82 and 86 are incompatible with the use of a dilator, as taught by Branch. Id. at 11. Dr. Youssef testifies that he believe[s] that if a device combining the guide tubes of Koros were to be added to the retractor portions of Branch, that combination would result in a device that would be dangerous when used in conjunction with a dilator. For example, the addition of the guide tubes would prevent the retractor of Branch from closing completely around the dilator during insertion. Instead, the retractor would be partially open where it could likely damage the surrounding tissues during insertion, or allow for tissue or nerves to creep beneath the retractor blades, thus restricting appropriate visualization of the disc space. Youssef Decl. ¶ 10. Patent Ownerâs arguments and Dr. Youssefâs declaration are not persuasive of nonobviousness. Koros describes that prior art distractor (i.e., retractor) blades used in spinal surgery were known in the art to âinclude a channel or slot for receiving a single fixation screw,â but Koros discovered that additional fixation screws would provide improved stability and support. Koros, col. 6, ll. 26-31. Koros teaches that tubular guides 82 and 86 allow for pairs of fixations screws 83 and can support a light for the surgical site. Id., col. 6, ll. 35-40. Koros further teaches that âscrews 83 are inserted through tubular Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 12 guides 82 . . . and screwed into adjacent disc 94 and 96.â Id., col. 6, ll. 66- col. 7, l.1. Dr. Youssefâs declaration is based on unsupported speculation about the operation of a non-existent device. Moreover, the arguments are based on the bodily incorporation of not only the fixations screws but the tubular screw guides disclosed in Koros into the device of Branch, including the relative size of the screws and tubular guides, without consideration of how one of ordinary skill in the art would have considered and adapted the teachings of Koros to the device of Branch. Notably, Koros discloses that alternative embodiments of configuring fixations screws were known in the art, and, thus, the skilled artisan was not limited to the precise tubular-guide- with-screws embodiment described in Koros. âThe test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference. . . . Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.â In re Keller, 642 F.2d 413, 425 (CCPA 1981). âA person of ordinary skill is also a person of ordinary creativity, not an automaton.â KSR, 550 U.S. at 421. We note that the claims require a method step of âreleasably engaging a fixation element with at least one of the plurality of retractor blades so that a distal portion of the fixation element extends distally from the at least one retractor blade and penetrates into a lateral aspect of the lumbar spine, wherein the fixation element secures the at least one retractor blade to the lumbar spine.â Based on the teachings of Koros, the skilled artisan would have recognized the benefit of fixation elements to fix retractors to aspects Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 13 of the lumbar spine for stability and support. â[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.â KSR, 550 U.S. at 417. In this case, it is the technique of fixing the retractor to the spine with a fixation element, and not the actual incorporation of the structure, which would have been obvious to the skilled artisan. Moreover, claim 17 requires âeach of said plurality of retractor blades having a generally concave inner face.â Claim 17 does not require that the fixation element also have a generally concave inner face. We note that the retractor blades of Koros have generally concave inner faces, demonstrating the compatibility of the fixation elements of Koros with retractor blades having a concave inner face. For this reason, we REVERSE the Examinerâs decision not to adopt the proposed rejections of Requester. Accordingly, we enter New Grounds of Rejection of claims 17, 18, and 24 under 35 U.S.C. § 103(a) as being obvious over Branch in view of Kossmann and Koros. Patent Owner incorporates the rejection of claim 26 into the arguments presented above with respect to claim 17. PO Res. Br. 3 and 11. Accordingly, we also enter New Grounds of Rejection of claim 26 under 35 U.S.C. § 103(a) as being obvious over Branch in view of Kossmann, Koros, and Tsou. We adopt the findings and reasoning of the Requester put forth in the Request in light of our findings and reasoning presented above for all of the claims so rejected. Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 14 PROPOSED REJECTIONS 2 and 5 Branch, Kossmann, Koros, and Kelleher The Rejection Claims 19-22 and 27 Claims 19-22 and 27 depend from claim 17. The claims further recite âthe steps of performing neuromonitoring during at least one of steps (a), (c), and (d), wherein a control unit of a neuromonitoring system displays a result of said neuromonitoring to a user.â Relying on the rationale discussed above with respect to claim 17, the Examiner did not adopt the proposed rejections of claims 19-22 and 27. We review these rejections in light of our decision above that the Examiner erred in withdrawing the rejection of claims 17. Requester contends that Kelleher describes a neuromonitoring method for use in spinal surgery falling within the scope of the claims on appeal that is use to inform the operator that a surgical tool or probe is approaching a nerve. Request 36-37 and 45-46. According to Requester, it would have been obvious to one of ordinary skill in the art to employ the method of neuromonitoring disclosed in Kelleher with the spinal surgical techniques disclosed in Branch, Kossmann, and Koros. Id. at 37 and 46. Issue The issue for this rejection is: By preponderance of the evidence, would it have been obvious to one of ordinary skill in the art to have used the neuromonitoring method described in Kelleher in the dilation and retraction methods described in Branch in view of Kossmann? Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 15 Discussion In addition to the argument discussed above with respect to the teachings of Branch, Kossmann and Koros, Patent Owner contends that there is no disclosure or suggestion in Kelleher of âperforming nerve monitoring during at least one of steps (a), (c), and (d)â of claim 17, âwherein a control unit of a neuromonitoring unit displays a result of said neuromonitoring to a user,â as recited in claim 19. PO Res. Br. 12. Requester identified specific findings that the system of Kelleher described performing nerve monitoring âwhile accessing a surgical site within a spine wherein a control unit of a neuromonitoring system displays a result of said neuromonitoring to a user.â Request 37-38; Req. Reb. Br. 13 (citing Kelleher, 2:19-23, 4:1-14, 6:1-6, 15:17-27, and Figure 1). Likewise, Requester made specific findings for each of the limitations of claims 19-22 and 27. See Request 37-41 and 46-48. These findings were acknowledged and accepted by the Examiner during Reexamination. See Non-Final Office Action mailed April 4, 2012 at 5-6 and 8-9. Patent Owner has not adequately explained why these findings by the Requester do not meet the requirements of the claims. Moreover, we agree with Requester that â[b]ecause each reference [namely, Branch and Kossmann] teaches the desireability of avoiding nerves for patient safety and Kelleherâs neuromonitoring would achieve this, it would have been obvious to look to a reference such as Kelleher, which similarly discloses a minimally-invasive spinal surgical system.â Req. Reb. Br. 11-12. One of ordinary skill in the art would have recognized the benefit of using a neuromonitoring system as taught by Kelleher for the purpose Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 16 taught by Kelleher, namely âto inform the operator that a surgical tool or probe is approaching a nerve.â See Request 37. To do so would have been no more than the predictable use of a known neuromonitoring system according to its established function of detecting nerves during spinal surgery. See KSR, 550 U.S. at 417 (The question to be asked is âwhether the improvement is more than the predictable use of prior art elements according to their established functions.â). For this reason, we REVERSE the Examinerâs decision not to adopt the proposed rejections of Requester. Accordingly, we enter New Grounds of Rejection of claims 19-22 under 35 U.S.C. § 103(a) as being obvious over Branch in view of Kossmann, Koros, and Kelleher and claim 27 under 35 U.S.C. § 103(a) as being obvious over Branch in view of Kossmann, Koros, Tsou, and Kelleher. Patent Owner incorporates the rejection of claim 27 into the arguments presented above with respect to claim 19. PO Res. Br. 11-12. We adopt the findings and reasoning of the Requester put forth in the Request in light of our findings and reasoning presented above for all of the claims so rejected. PROPOSED REJECTION 3 Branch, Kossmann, Koros, and Michelson The Rejection Claim 25 Claim 25 depends from claim 17. The claim further recites âthe fixation element comprises a shim structure to penetrate into the targeted lumbar spinal disc.â Relying on the rationale discussed above with respect Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 17 to claim 17, the Examiner did not adopt the proposed rejections of claim 25. We review this rejection in light of our decision above that the Examiner erred in withdrawing the rejection of claim 17. Requester acknowledges that Koros does not describe a fixation element comprising a shim. However, Requester finds that Michelson describes such a fixation element for use in spinal surgery. Request 41-42. According to Requester, it would have been obvious to one of ordinary skill in the art to employ the disc-penetrating shim structure of Michelson with the spinal surgical instrumentation disclosed in Branch, Kossmann, and Koros. Id. at 42. Issue The issue for this rejection is: By preponderance of the evidence, would it have been obvious to one of ordinary skill in the art to have used the disc-penetrating shim structure of Michelson as an alternative to the releasably engaging screw fixation elements of Koros in the dilation and retraction methods described in Branch in view of Kossmann? Discussion In addition to the argument discussed above with respect to the teachings of Branch, Kossmann and Koros, Patent Owner contends that âone of skill would not have looked to Michelson for teachings on how to modify tissue retractors or a retractor-based access systemâ and rather teaches away from such a combination âbecause Michelson discloses a tubular-based access system including a tubular access cannula 140.â PO Res. Br. 13-14. Patent Owner further contends that âthe resulting combination would be a Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 18 permanent retractor blade extension, not an intradiscal shim element that is releasably engaged with a retractor blade, as required by claim 17.â Id. at 14. We are not persuaded by Patent Ownerâs arguments and agree with Requester that it would have been obvious to one of ordinary skill in the art to have used a shim as an alternative fixation element to the releasably engaging screws of Koros for disc penetration. Michelson describes âtwo prongs âsufficiently spaced apart to penetrate and hold fixed the two adjacent vertebraeâ as well as a shim-like extension member that penetrates into the disc space.â Request 41-42 (quoting Michelson, col. 10, ll. 58-67 and citing Michelson, Figs. 7A and 10). Michelsonâs shim performs the same purpose in the spinal access device of Michelson as the screws do in the device of Koros, namely âto maintain the distraction and alignment of the adjacent vertebrae created by the distractor 100.â Michelson, col. 11, ll. 45-47. Accordingly, Michelson describes a shim as a predictable alternative to a screw for use in a spinal access device. See KSR, 550 U.S. at 416 (âwhen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.â). The fact that the shim structure of Michelson is used with a different type of spinal access device does not teach away from using a shim rather than the screw of Koros. In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004) (explaining â[t]he prior artâs mere disclosure of more than one alternative does not constitute a teaching Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 19 away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimedâ). We further disagree with the Patent Owner that combining the teachings of Branch, Koros, and Michelson would necessarily result in a fixed shim element. Using a shim as an alternative releasably engaging fixation element would have been obvious to the skilled artisan because the Koros reference describes that the screws releasably engage with the retractor blades. We find that replacing a screw with a shim would have been within the skill of the ordinary artisan, as both are described in the art as fixation elements for spinal surgery. For this reason, we REVERSE the Examinerâs decision not to adopt the proposed rejection of Requester. Accordingly, we enter New Grounds of Rejection of claim 25 under 35 U.S.C. § 103(a) as being obvious over Branch in view of Kossmann, Koros, and Michelson. We adopt the findings and reasoning of the Requester put forth in the Request in light of our findings and reasoning presented above for all of the claims so rejected. DECISION In sum, we reverse the Examinerâs decision not to reject the claims as follows and enter new grounds of rejections based on the reasoning and discussion above: claims 17, 18, and 24 as rendered obvious by Branch in view of Kossmann, and Koros (Ground 1; RAN 2); claims 19-22 as rendered obvious by Branch in view of Kossmann, Koros, and Kelleher (Ground 2; RAN 2); Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 20 claim 25 as rendered obvious by Branch in view of Kossmann, Koros, and Michelson (Ground 3; RAN 2); claim 26 as rendered obvious by Branch in view of Kossmann, Koros, and Tsou (Ground 4; RAN 2); and claim 27 as rendered obvious by Branch in view of Kossmann, Koros, Tsou, and Kelleher (Ground 5, RAN 2). NEW GROUND OF REJECTION This decision contains new grounds of rejection pursuant to 37 C.F.R. § 41.77(b) which provides that â[a]ny decision which includes a new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.â Correspondingly, no portion of the decision is final for purposes of judicial review. A requester may also request rehearing under 37 C.F.R. § 41.79, if appropriate, however, the Board may elect to defer issuing any decision on such request for rehearing until such time that a final decision on appeal has been issued by the Board. For further guidance on new grounds of rejection, see 37 C.F.R. § 41.77(b)-(g). The decision may become final after it has returned to the Board. 37 C.F.R. § 41.77(f). 37 C.F.R. § 41.77(b) also provides that the Patent Owner, WITHIN ONE MONTH FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. The owner may file a response requesting reopening of prosecution before the examiner. Such a response must be Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 21 either an amendment of the claims so rejected or new evidence relating to the claims so rejected, or both. (2) Request rehearing. The owner may request that the proceeding be reheard under § 41.79 by the Board upon the same record. ⊠Any request to reopen prosecution before the examiner under 37 C.F.R. § 41.77(b)(1) shall be limited in scope to the âclaims so rejected.â Accordingly, a request to reopen prosecution is limited to issues raised by the new ground(s) of rejection entered by the Board. A request to reopen prosecution that includes issues other than those raised by the new ground(s) is unlikely to be granted. Furthermore, should the patent owner seek to substitute claims, there is a presumption that only one substitute claim would be needed to replace a cancelled claim. A requester may file comments in reply to a patent owner response. 37 C.F.R. § 41.77(c). Requester comments under 37 C.F.R. § 41.77(c) shall be limited in scope to the issues raised by the Board's opinion reflecting its decision to reject the claims and the patent owner's response under paragraph 37 C.F.R. § 41.77(b)(1). A newly proposed rejection is not permitted as a matter of right. A newly proposed rejection may be appropriate if it is presented to address an amendment and/or new evidence properly submitted by the patent owner, and is presented with a brief explanation as to why the newly proposed rejection is now necessary and why it could not have been presented earlier. Compliance with the page limits pursuant to 37 C.F.R. § 1.943(b), for all patent owner responses and requester comments, is required. Appeal 2013-009128 Reexamination Control 95/001,888 Patent 7,691,057 B2 22 The examiner, after the Board's entry of a patent owner response and requester comments, will issue a determination under 37 C.F.R. § 41.77(d) as to whether the Board's rejection is maintained or has been overcome. The proceeding will then be returned to the Board together with any comments and reply submitted by the owner and/or requester under 37 C.F.R. § 41.77(e) for reconsideration and issuance of a new decision by the Board as provided by 37 C.F.R. § 41.77(f). REVERSED; NEW GROUNDS OF REJECTION UNDER 41.77(B) PATENT OWNER: FISH & RICHARDSON P.C. (TC) PO BOX 1022 MINNEAPOLIS MN 55440-1022 THIRD-PARTY REQUESTER: Jay Guiliano, Esq. NOVAK DRUCE & QUIGG LLP 300 New Jersey Ave., NW Fifth Floor Washington, DC 20001 Copy with citationCopy as parenthetical citation