Ex Parte 7819801 et al

Patent Trial and Appeal BoardJun 30, 2014

95001889 (P.T.A.B. Jun. 30, 2014)

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. 95/001,889 02/09/2012 7819801 20330.0002.RX801 7613 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 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 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. (“Requester”) appeals under 35 U.S.C. §§ 134(c) and 315(b) the Examiner’s decision not to reject claims 1, 2, 6-10, 12-17, 19, 21, 26, 27, and 29. 1 We have jurisdiction under 35 U.S.C. §§ 134(c) and 315(b). 1 See Requester’s Appeal Brief 1-2 (filed January 16, 2013) (hereinafter “Req. App. Br.”); Examiner’s Answer (mailed March 29, 2013), Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 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. We AFFIRM the Examiner’s decision not to adopt any of the proposed grounds of rejection on appeal. STATEMENT OF THE CASE United States Patent 7,819,801 B2 (hereinafter the “’801 patent”), which is the subject of the current inter partes reexamination, issued to Patrick Miles, et al. on October 26, 2010. The ’801 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 ’801 patent is also related to U.S. Patent 7,691,057, which is the subject of Reexamination Control 95/001,888, currently on appeal and heard on April 30, 2014 along with this reexamination. The ’801 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 ’801 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. incorporating by reference the Examiner’s Right of Appeal Notice (mailed October 16, 2012) 1 and 5 (hereinafter “RAN.”). Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 3 Patent Owner, NuVasive, Inc. 2 (hereinafter “Patent Owner”) filed a Respondent Brief in this appeal. The ’801 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. ’801 patent, Abstract and col. 2, ll. 47-49. Claim 1 is the sole independent claim on appeal and was not amended during reexamination. Claim 1 reads as follows: 1. A system for accessing a surgical target site, comprising: a dilator system comprising a plurality of sequential dilators deliverable along a lateral, trans-psoas path to a targeted spinal site to create a distraction corridor; a handle assembly including a first pivotable arm member, a second pivotable arm member that pivots relative to said first arm member in response to manual adjustment of a component of the handle assembly, and a translating member adapted to move longitudinally relative to said first and second arm members; a first retractor blade having a generally concave inner- facing surface and being rigidly coupled to said first pivotable arm member prior to introduction toward the targeted spinal site, a second retractor blade having a generally concave inner- facing surface and being rigidly coupled to said second pivotable arm member prior to introduction toward the targeted spinal site, and a third retractor blade rigidly coupled to said translating member prior to introduction toward the targeted spinal site; 2 See Patent Owner Respondent Brief 1 (filed February 19, 2013) (hereinafter “PO Res. Br.”). Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 4 an intradiscal shim element that releasably mounts to the third retractor blade such that a maximum length of the intradiscal shim element extends generally parallel to a maximum length of the third retractor blade and a distal tip portion of the intradiscal shim element extends distally of the distal end of the third retractor blade, wherein the intradiscal shim element engages with a groove defined by the third retractor blade to penetrate into a spinal disc at the targeted spinal site when the intradiscal shim element is releasably mounted to the third retractor blade; and said handle assembly being configured to simultaneously introduce said first, second and third retractor blades along the lateral, trans-psoas path toward the targeted spinal site in a closed position while the generally concave inner-facing surfaces of said first and second retractor blades engage with an outermost dilator of the dilator system and thereafter opened by pivoting said first and second pivotable arm members relative to one another to create an operative corridor to said surgical target site. (Req. App. Br. 29, Claims App’x.) Requester appeals the Examiner’s decision not to reject the claims as follows: I. claims 1, 2, 17, 19, 21, 26, 27, and 29 as rendered obvious by Branch 3 in view of Maeda, 4 Koros, 5 Michelson, 6 and Kossmann 7 (Ground 1; RAN 2); 3 US 6,945,933 B2, issued September 20, 2005 to Charles L. Branch et al. 4 US 5,681,265, issued October 28, 1997 to Koutaroa Maeda et al. 5 US 5,928,139, issued July 27, 1999 to Tibor B. Koros, et al. 6 US 5,772,661, issued June 30, 1998 to Gary Karlin Michelson. 7 Thomas Kossmann, et al., “Minimally Invasive Vertebral Replacement with Cages in Thoracic and Lumbar Spine,” European J. of Trauma, 27(6):292-300 (2001). Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 5 II. claims 6-10 and 12-16 as rendered obvious by Branch in view of Maeda, Koros, Michelson, Kossmann, and Blewett 8 (Ground 2; RAN 2). The Requester relies on the Declaration of Isador H. Lieberman executed July 18, 2012 and attached exhibits (Ex. 1, App. Br. 32, Evidence App’x) (hereinafter “Lieberman Declaration” or “Lieberman Decl.”). Patent Owner relies on the Declaration of Jim Youssef executed June 25, 2012 (Ex. 2, App. Br. 32, Evidence App’x; PO Res. Br. 16, Evidence App’x) (hereinafter “Youssef Declaration” or “Youssef Decl.”). PROPOSED REJECTION 1 Branch, Maeda, Koros, Michelson, and Kossmann Claims 1, 2, 17, 19, 21, 26, 27, and 29 The Proposed Rejection Requester contends that Branch teaches a system for accessing a surgical target site of the spine having most of the features recited in claim 1. Request for Inter Partes Reexamination 38-42 (filed February 9, 2012) (hereinafter “Request”); Req. App. Br. 4-26. However, Requester acknowledges that the system taught by Branch includes only two retractor blades instead of the recited three retractor blades, does not describe an intradiscal shim as recited in the claims, and describes the system taught by Branch to be delivered along a lateral path to the spine which is not specific 8 WO 03/005887 A2, published January 23, 2003, naming Jeffrey Blewett et al. as inventors. Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 6 to a lateral, trans-psoas path as recited in claim 1. Requester contends that retractor devices were known in the art having three retractor blades, as disclosed by Maeda. Req. App. Br. 5-6. Issues The dispositive 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 modified the retractor of Branch to have a third retractor blade rigidly coupled to a translating member of a handle assembly, as taught by Maeda? Discussion Patent Owner contends, inter alia, that one of skill in the art would not have looked to Maeda’s anal retractor design to modify the Branch retractor system, which is a retractor system for spinal surgery. PO Res. Br. 4. In support of this argument, Patent Owner relies on the testimony of Dr. Youssef, who opines that the tubular body opening, such as an anus, presents very different design challenges for a retractor device introduced into an incision. Id.; see Youssef Decl. ¶ 15. Dr. Youssef further opines that a retractor must meet the particular needs of the location of the surgical procedure and the body anatomy encountered. Id. On this point, Requester contends that it would be obvious for one of ordinary skill in the art to look to other medical retractors (as they are all functionally similar devices) for features that may be incorporated into a retractor for a specific surgical method or technique. Req. Reb. Br. 4. In support thereof, Requester relies on testimony of Dr. Lieberman, who opines that all retractors are designed to retract tissue and the teachings of a Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 7 retractor are not limited to a single application. Id. at 4-5; see Lieberman Decl. ¶18. Requester also points to the specification of the ’801 patent, which states that “although described herein largely in terms of use in spinal surgery, the access system of the present invention is suitable for use in any number of additional surgical procedures wherein tissue having significant neural structures must be passed through (or near) in order to establish an operative corridor.” ’801 patent, col. 2, ll. 54-59. “To qualify as prior art for an obviousness analysis, a reference must qualify as ‘analogous art,’ i.e., it must satisfy one of the following conditions: (1) the reference must be from the same field of endeavor; or (2) the reference must be reasonably pertinent to the particular problem with which the inventor is involved.” K-TEC, Inc. v. Vita-Mix Corp., 696 F.3d 1364, 1375 (Fed. Cir. 2012). “If a reference disclosure has the same purpose as the claimed invention, the reference relates to the same problem, and that fact supports use of that reference in an obviousness rejection.” In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). We agree with Requester that one of ordinary skill in the art would have looked to retractor devices used in other types of surgical application to improve known spinal retractors used in spinal surgery. There is sufficient evidence of record to suggest that retractors are used substantially for the same purpose, namely retracting body tissue. However, the mere presence of a known feature in an analogous art is insufficient for a determination of obviousness. “[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int'l Co. v. Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 8 Teleflex Inc., 550 U.S. 398, 418 (2007); In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (quoted with approval in KSR, 550 U.S. at 418) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). The Supreme Court clarified that “it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR, 550 U.S. at 418. Requester has not presented an articulated reason with rational underpinnings as to why the skilled artisan would have made the modifications to Branch’s spinal retractor, even if a three bladed retractor was known in analogous art. The Requester has identified no benefit to spinal surgery from a three bladed retractor over the two bladed retractor of Branch. Nor has the requester identified any problem in the art solved by the use of a three bladed retractor over a two bladed retractor. Requester argues that a three bladed retractor would have been “[o]bvious to try” because “[t]here are a finite number of retractor designs used within an operating room, and since retractors are all used for the same basic purpose of retracting tissue.” Req. App. Br. 22. Alternatively, Requester makes conclusory arguments or contends that because the art is analogous, the skilled artisan would use features of one type of retractor in another type. Req. App. Br. 21 (“[I]t would be obvious to combine different combinations of preexisting features.”); Req. Reb. Br. 5 (“[I]t would be obvious for one of ordinary skill in the art to look to other medical retractors (as they are all Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 9 functionally similar devices) for features that may be incorporated into a retractor for a specific surgical method or technique.”); Request 24 and 40 (“[I]t would have been obvious to a person of ordinary skill in the art to use a similar instrument and approach for accessing a surgical site through another orifice, such as a surgical incision.”). The record before us lacks probative evidence to support the Requester’s position that “there are a finite number of retractor designs used within an operating room.” To the contrary, the record shows there are a great variety of retractors for use with spinal surgery alone. KSR instructs us that “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton,” KSR, 550 U.S. at 421, and that “[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.” Id. at 417. Requester has not established that a skilled artisan would recognize that a three bladed retractor is an improvement in the art or that having three blades would have improved the Branch retractor in any way. Requester is proposing more than the simple and predictable substitution of one known retractor for another, but rather, is proposing the combination of features of two different retractors. Moreover, without a clear understanding of a reason that the skilled artisan would have to make the proposed modification, one cannot readily evaluate whether or not the modification would have been predictably successful. A relevant reason for the skilled artisan to have made the proposed combination was first presented by counsel for Patent Owner during oral Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 10 arguments. 9 This reasoning was subsequently also mentioned by counsel for Requester. 10 However, when challenged, counsel for Requester could not point to any evidence in the record to support a finding of operational differences between a two bladed retractor and a three bladed retractor beyond unsupported “common sense.” 11 Accordingly, in addition to being untimely presented, we consider the statements made in oral argument as mere attorney argument that lacks evidentiary support. Without a clear explanation that is supported by the evidence of record for why the skilled artisan would have modified the device of Branch to have three rather than two retractor blades, we can only infer the Requester’s basis is conclusory and relies on hindsight reasoning. In re Rouffet, 149 F.3d 1350, 1358 (Fed. Cir. 1998) (“hindsight” is inferred when the specific understanding or principal within the knowledge of one of 9 Transcript 49:12-20 (“[T]here is an advantage to a three-bladed retractor. That’s why NuVasive claimed it. And, again, with the specific features that are in the claim, one in particular, they talk about the ability to customize that surgical opening. That three-bladed retractor is important to do that, rather than having two blades where you’re sort of locked into a, either a circle or maybe an elliptical-type shape.”). 10 Transcript 56:3-7 (“You get a better view, you get a different view when you use three blades than two of the surgical site. You have more of a circular opening versus an oval opening, and you also -- having three blades would obviously provide more contact points to hold the tissue back.”). 11 See Transcript 56:8-15 (“JUDGE GUEST: Is that just argument or is that supported by either the declarations of Dr. Lieberman or in the Maeda reference? MR. O'NEILL: Well, I would say it would be something along the lines of a doctor -- a surgeon would – it’s common sense to them, one over another. . . . And all retractors perform the same function, they retract tissue.”). Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 11 ordinary skill in the art leading to the modification of the prior art in order to arrive at Appellant’s claimed invention has not been explained). Accordingly, we agree with the Examiner’s determination not to adopt the rejection of claims 1, 2, 17, 19, 21, 26, 27, and 29 as being obvious over Brach in view of Maeda, Michelson, and Kossmann, claims 2, 17, 19, 21, 26, 27, and 29 depending from claim 1. PROPOSED REJECTION 2 Branch, Maeda, Koros, Michelson, Kossmann, and Blewett The Rejection Claims 6-10 and 12-16 Claims 6-10 and 12-16 depend from claim 1. Requester relies on Branch and Maeda in the same manner discussed above for claim 1. Thus, for the same reasons, we agree with the Examiner’s determination not to adopt the rejection of claims 6-10 and 12-16 as being obvious over Branch in view of Maeda, Koros, Michelson, Kossmann, and Blewett. DECISION In sum, we affirm the Examiner’s decision not to reject: Claims 1, 2, 17, 19, 21, 26, 27, and 29 under 35 U.S.C. § 103(a) as obvious over Branch in view of Maeda, Michelson, and Kossmann; and Claims 6-10 and 12-16 under 35 U.S.C. § 103(a) as obvious over Branch in view of Maeda, Koros, Michelson, Kossmann, and Blewett; AFFIRMED Appeal 2013-009129 Reexamination Control 95/001,889 Patent 7,819,801 B2 12 In the event neither party files a request for rehearing within the time provided in 37 C.F.R. § 41.79, and this decision becomes final and appealable under 37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice on the Director of the United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983. 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