10912917 (B.P.A.I. Jan. 31, 2011)

Ex Parte Gunderson

Board of Patent Appeals and InterferencesJan 31, 2011

10912917 (B.P.A.I. Jan. 31, 2011)

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. 10/912,917 08/06/2004 Richard C. Gunderson S63.2B-11625-US01 4278 490 7590 02/01/2011 VIDAS, ARRETT & STEINKRAUS, P.A. SUITE 400, 6640 SHADY OAK ROAD EDEN PRAIRIE, MN 55344 EXAMINER TYSON, MELANIE RUANO ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 02/01/2011 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 BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte RICHARD C. GUNDERSON ____________ Appeal 2009-011386 Application 10/912,917 Technology Center 3700 ____________ Before JENNIFER D. BAHR, STEVEN D.A. MCCARTHY and FRED A. SILVERBERG, Administrative Patent Judges. McCARTHY, Administrative Patent Judge. DECISION ON APPEAL1 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2009-011386 Application 10/912,917 2 The Appellant appeals under 35 U.S.C. § 134 from the Examiner’s 1 decision finally rejecting claims 1 and 3-20. More specifically, the 2 Examiner rejects claims 1 and 3-15 under 35 U.S.C. § 103(a) as being 3 unpatentable over Yurek (US 5,690,644, issued Nov. 25, 1997) and claims 4 16-20 under § 103(a) as being unpatentable over Yurek and Thornton (US 5 2005/0070997 A1, publ. Mar. 31, 2005). We have jurisdiction over the 6 appeal under 35 U.S.C. § 6(b). 7 We REVERSE. 8 The claims on appeal are directed to a delivery system including a 9 catheter configured to deliver a self-expanding stent. (Spec. 4, ll. 14-16). 10 The catheter includes a sheath 40 moveable between two positions, an 11 extended position as illustrated in Figure 1 and a retracted position as 12 illustrated in Figure 3. 13 Claim 1 is sole independent claim and illustrative of the claims on 14 appeal. 15 1. A medical device comprising: 16 a catheter, the catheter having a catheter 17 shaft, a portion of the catheter shaft defining a 18 stent receiving region; 19 a sheath, the sheath being disposed about the 20 catheter shaft and being longitudinally moveable 21 relative thereto, a distal portion of the sheath 22 defining a stent retaining region, the sheath being 23 moveable between an extended position and a 24 retracted position, in the extended position the 25 retaining region being disposed about the stent 26 receiving region, in the retracted position the 27 sheath being removed from the stent receiving 28 region; 29 Appeal 2009-011386 Application 10/912,917 3 a membrane, a distal region of the 1 membrane being engaged to a distal portion of the 2 sheath, a proximal region of the membrane being 3 engaged to a portion of the catheter shaft proximal 4 of the stent receiving region, in the extended 5 position the membrane being positioned between 6 the catheter shaft and the sheath and a portion of 7 the membrane being disposed about at least a 8 portion of the stent receiving region, in the 9 retracted position the membrane being removed 10 from about the at least a portion of the stent 11 receiving region; and 12 a fluid chamber, the fluid chamber having a 13 proximal region and a distal region, the proximal 14 region being defined by the catheter shaft and the 15 sheath, in the extended position the distal portion 16 of the fluid chamber being defined by the 17 membrane and the sheath and in the retracted 18 position the distal portion of the fluid chamber 19 being defined by said membrane. 20 Yurek discloses a deployment device configured to simplify treatment 21 procedures for delivering an implantable stent. Yurek’s device simplifies 22 these procedures by employing a substantially shorter guidewire. (Yurek, 23 col. 7, ll. 47-59). Yurek’s configuration, including an aperture 52, an axial 24 slit 53 and a groove 56, provides an example of reducing guidewire length in 25 a conventional arrangement from 460 cm to 245 cm. (Yurek, col. 6, ll. 12-26 24 and 34-42; and col. 7, ll. 37-46). 27 Yurek describes multiple embodiments for delivering self-expanding 28 stents via catheters. In a first embodiment represented by Figures 9-13, 29 Yurek describes the use of a rolling membrane 70. The rolling membrane 30 70 doubles over itself near a distal tip 72 of the device 16 to form an inner 31 layer 74 and an outer layer 76. (Yurek, col. 8, ll. 12-14). The outer layer 76 32 Appeal 2009-011386 Application 10/912,917 4 is bonded at its proximal end to the distal end of an exterior catheter 64. 1 (Yurek, col. 8, ll. 18-20 and fig. 9). During the delivery of the stent 62, the 2 membrane 70 peels back from around the stent to allow the stent to 3 progressively self-expand. (Yurek, col. 8, ll. 47-50). Yurek teaches that the 4 membrane has sufficient elastic strength to overcome the stent restoring 5 force so long as the layers 74, 76 surround the stent 62. (Yurek, col. 8, ll. 6 14-17). 7 As acknowledged by the Examiner on page 3 of the Answer, in the 8 embodiment illustrated in Figures 9-13, “Yurek fails to disclose the sheath 9 (64) is disposed about the stent receiving region when in the extended 10 position,” as called for in claim 1. 11 In a second, and distinct, embodiment illustrated in Figures 1-8, 12 Yurek describes an exterior catheter (sheath) 20 that is pulled back off of an 13 interior catheter 38 to release the radially self-expanding stent 18. In the 14 second embodiment, the coefficient of friction of the exterior catheter 20 15 along its interior surface is preferably less than the coefficient of friction for 16 the exterior surface of the interior catheter 38. As the exterior catheter 17 (sheath) 20 is pulled back, the stent 18 tends to remain stationary relative to 18 the inner catheter. (Yurek, col. 5, ll. 37-43 and col. 7, ll. 12-19). 19 Based on the above first and second embodiment, the Examiner 20 concludes it would have been obvious 21 to modify the embodiment shown in Figures 9-13, 22 such that the sheath (64) is disposed over the inner 23 membrane [74] that is disposed over the stent 24 receiving region. Doing so would provide 25 additional strength to overcome the stent restoring 26 force and ensure the stent is maintained in a 27 Appeal 2009-011386 Application 10/912,917 5 reduced radius during the stent delivery, thus 1 facilitating the procedure. 2 (Ans. 3-4). 3 Additionally, the Examiner reasons 4 . . . that to modify the embodiment shown in 5 Figures 9-13, such that the sheath (64) is disposed 6 over the inner membrane [74] that is disposed over 7 the stent receiving region, would have yielded 8 predictable results, namely, a delivery device 9 having sufficient strength to maintain the stent in a 10 reduced radius and axially elongated delivery 11 configuration. Furthermore, a rigid sheath would 12 provide greater resistance to an elastic restoring 13 force of the stent than a highly pliable and flexible 14 outer layer membrane, and such additional strength 15 would be recognized as being beneficial in 16 ensuring this desired effect is achieved or in 17 actually enhancing this desired effect. 18 (Ans. 5). 19 20 The Appellant is correct in arguing that “[i]t is only within Appellant's 21 disclosure that a sheath and membrane [are] employed in combination, 22 wherein a fluid chamber is maintained between the two for reducing 23 frictional forces, and it is only with the use of impermissible hindsight, using 24 that such a modification would be made.” (Reply Br. 6). The Examiner has 25 not provided a sound basis for belief that a rigid sheath would provide 26 meaningfully greater resistance to an elastic restoring force of the stent than 27 would the membrane 70. Yurek teaches that the membrane has sufficient 28 elastic strength to overcome the stent restoring force so long as the layers 74, 29 76 surround the stent 62 (Yurek, col. 8, ll. 14-17), leaving no problem to be 30 solved by the proposed modification. Consequently, the Examiner has not 31 Appeal 2009-011386 Application 10/912,917 6 articulated a sufficient rational underpinning for the conclusion of 1 obviousness. We do not sustain the rejections of claims 1 and 3-15 under 2 § 103(a) as being unpatentable over Yurek. 3 Turning to the rejection of claims 16-20 under § 103(a), Thornton 4 describes a drug-polymer coated stent 120 coupled to a delivery catheter 5 110. (Thornton, para. [0030]). The Examiner does not explain how the 6 teachings of Thornton might remedy the deficiency in the disclosure of 7 Yurek pointed out in connection with the rejection of clam 1. Since the 8 Examiner’s conclusion of obviousness lacks rational underpinning, we do 9 not sustain the Examiner’s final decision rejecting claims 16-20 under 10 § 103(a) as being unpatentable over Yurek and Thornton. 11 12 DECISION 13 We REVERSE the Examiner’s decision finally rejecting claims 1 and 14 3-20. 15 16 REVERSED 17 18 19 20 Klh 21 22 VIDAS, ARRETT & STEINKRAUS, P.A. 23 SUITE 400, 6640 SHADY OAK ROAD 24 EDEN PRAIRIE, MN 55344 25