Ex Parte Burton et al

Patent Trial and Appeal BoardSep 17, 2012

10593376 (P.T.A.B. Sep. 17, 2012)

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. 10/593,376 07/09/2007 David G. Burton 8627-1391 (PA-5511-PCT/US 8852 48003 7590 09/17/2012 BRINKS HOFER GILSON & LIONE/CHICAGO/COOK PO BOX 10395 CHICAGO, IL 60610 EXAMINER WEBB, SARAH K ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 09/17/2012 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 __________ Ex parte DAVID G. BURTON and CHRISTOPHER G. DIXON __________ Appeal 2011-009032 Application 10/593,376 Technology Center 3700 __________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims relating to dilation catheters, which the Examiner has rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The Specification discloses that dilation catheters use “a medical balloon for applying pressure against the interior of a biological conduit, such as a blood vessel” (Spec. 1, ¶ 0002). App App whic at 3, unfo work leng Figu equip ¶ 002 secti eal 2011-0 lication 10 Figure 1 Figure 1 h includes ¶ 0009). T lded confi ing length th-to-taper Figure 2 re 2 shows ped with 1). The t on is more 09032 /593,376 of the Spe shows a c a working he Specif guration, i and the p transition of the Spe a “cross- an enlarge ransition b rounded, cification ross-sectio length 13 ication sta ncludes sh roximal co ”) (id. at 4 cification sectional v d transitio etween th or has an e 2 is shown b n of a con 0 and pro tes that th arp bends nical regio , ¶¶ 0010, is shown b iew of a d nal radii m e working nlarged ra elow: ventional ximal coni e conventi at the tran n (i.e., th 0011). elow: ilation cath edical bal length and dius, com dilation ca cal section onal ballo sition betw e “proxima eter … th loon” (id. proximal pared to th theter, 125 (id. on, in its een the l working at is at 6, conical e Appeal 2011-009032 Application 10/593,376 3 conventional dilation catheter of Figure 1 (id. at 10, ¶ 0038). The Specification states that the disclosed balloons reduce during- and post- procedure trauma to patients (id. at 4-5, ¶ 0012). Claims 1, 3, 4, 12-16, 22, 24, and 25 are on appeal. Claim 1 is representative and reads as follows: 1. A dilation catheter comprising: an elongate catheter body with at least one lumen; and a medical balloon disposed about a portion of the elongate catheter body in fluid communication with the lumen, the medical balloon comprising: a proximal region and a distal region; a balloon working length intermediate the proximal region and the distal region; a proximal working length-to-taper transition; wherein the proximal working length-to-taper transition comprises a radius before inflation from: 0.97 to 3.3 mm when the balloon has a working length diameter of about 3 mm, … Claim 1 also specifies ranges for the radius of the proximal working length-to-taper transition for working length diameters of 4 mm to 15 mm. The full text of claim 1 is reproduced in the Claims Appendix of the Appeal Brief (page 12). Issue The Examiner has rejected claims 1, 3, 4, 12-16, 22, 24, and 25 under 35 U.S.C. § 103(a) as obvious in view of Lee1 and Bleam.2 The Examiner finds that Lee discloses a dilation catheter comprising an inflatable balloon that includes “a mid-section (44) that defines a ‘working length’ between 1 Lee, Patent Application Publication, US 2003/0139762 A1, July 24, 2003. 2 Bleam, US 5,797,878, Aug. 25, 1998. Appeal 2011-009032 Application 10/593,376 4 tapered proximal and distal regions” (Answer 3). The Examiner provides the following annotated version of Lee’s Figure 1 (id. at 4): The Figure shows “a perspective partially sectioned view of … [an] angioplasty balloon” (Lee 1, ¶ 0016), with the Examiner’s annotations indicating the working length, the working length-to-taper transition region and the neck-to-taper transition region. The Examiner finds that the tapered regions of Lee’s balloon “provide smooth transitions from the working diameter in section (44) to the small diameter of the neck regions (42 and 62)” (Answer 3-4), and that Lee “teaches that the tapered regions should be smooth in order to allow the balloon to traverse stenosis … but fails to disclose the specific radii of the transitions when the balloon is in a deflated state” (id. at 4). The Examiner finds that Bleam discloses a “balloon with a working length and proximal and distal tapers … and teaches that smaller taper angles and longer taper lengths can reduce these frictional forces” during movement through the vasculature (id. at 5). The Examiner concludes that “one of ordinary skill in the art would have found it obvious to combine the teachings of Lee and Bleam to form a balloon with transition zones that are smooth, rounded, and provide a gradual change in diameter … [to] form[ ] a Appeal 2011-009032 Application 10/593,376 5 balloon with a very smooth profile in the deflated state so it is easily maneuvered through vessels” (id.). The Examiner also concludes that “[a]lthough the specific dimensions of the transition radii are not explicitly disclosed by Lee and Bleam, … [c]hanging the radius of a rounded edge is within the level of ordinary skill in the art, and it is also well known that larger radii produce smoother profiles…. Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.” (Id. at 6, citing In re Aller, 220 F.2d 454 (CCPA 1955).) Appellants contend that “neither Lee nor Bleam disclose the enlarged radii” of claim 1 (Appeal Br. 7). Appellants argue that “Lee and Bleam only relate to the shape of the tapered regions and not to the transitions to the tapered regions. Thus, Lee and Bleam relate to an entirely different region of the balloon.” (Id.) Appellants provide two illustrations to support their position that the angle of a tapered region is not necessarily related to the smoothness of the transition to the tapered region (id. at 8). We agree with Appellants that the Examiner has not adequately explained how the cited references would have made obvious the working length-to-taper transition radius required by claim 1. Bleam discloses a balloon for dilation catheters that has a “tapered portion connecting the working length with the catheter tube” (Bleam, col. 2, ll. 52-54). Bleam discloses that the tapered portion extends “from the catheter tube at an angle which remains within the range of 7° and 20° whether the balloon is in an expanded, collapsed or deformed configuration, whereby the angle is optimized to enable the balloon to slide within the biological conduit” (id. at Appeal 2011-009032 Application 10/593,376 6 col. 2, ll. 54-59). The Examiner has not pointed to any disclosure in Bleam relating to the curvature of the transitions between the working length and tapered portions of Bleam’s catheter. Lee discloses improved “angioplasty catheter balloons” (Lee 1, ¶ 0002). Lee discloses that “the ends of the uninflated balloon should taper smoothly and lay low so that the balloon can be threaded into tight passages” (id. at 1, ¶ 0005), but “current production methods yield a balloon with stiff and bulky tapers” (id. 1, ¶ 0006). Lee discloses an angioplasty balloon that overcomes this problem by being made in such a way that its “a taper wall thickness [is] substantially equivalent to a working length wall thickness” (id. at 1, ¶ 0015). Thus, both Bleam and Lee disclose solutions to the problem of making a balloon for a dilation catheter maneuverable within the vasculature. Lee addresses this problem by maintaining an even wall thickness for the tapered regions and the working length, and Bleam addresses the problem by specifying the angle at which the tapered region extends from the tube to reach the working length. However, as the Examiner acknowledges (Answer 7), neither Lee nor Bleam discusses the radius or degree of curvature of the transition regions between the taper and the working length. The Examiner reasons that the radii of claim 1 would have been obvious because the cited references teach “smooth, gradual transition zones between a working length and proximal and distal tapered sections” (Answer 7). The Examiner also argues that it would have been obvious to optimize the radii of the transition zones to arrive at the claimed values (id. at 6), and Appeal 2011-009032 Application 10/593,376 7 that changing the shape of a rounded edge by changing the size of a corner’s radius is within the level of skill in the art (id. at 8-9). We disagree with the Examiner’s conclusion. It is true that Lee discloses that there should be a “smooth transition” between the working length and the smaller-diameter shaft distal and proximal to it (Lee 2, ¶ 0022). However, Lee’s focus is on ensuring that the tapered region and the working length have the same wall thickness to avoid stiff and bulky tapers that make it difficult to traverse a stenosis (see Lee 1, ¶¶ 0005-0006). Neither Lee nor Bleam suggest that the degree of curvature of the transition zones between the tapered regions and the working length affects the performance of their catheters. Thus, the Examiner’s reliance on In re Aller is in error. While “the discovery of an optimum value of a variable … is normally obvious,” one of the exceptions to that rule is the case “in which the parameter optimized was not recognized to be a result-effective variable.” In re Antonie, 559 F.2d 618, 620 (CCPA 1977). In the instant case, the Examiner has not established that the variable of transition curvature, as reflected in the recited proximal working length- to-taper transition radius, was recognized by those of ordinary skill in the art as a variable that would affect the results achieved with dilation balloons. Thus, the Examiner has not adequately explained why it would have been obvious to optimize this variable. Whether the modification was within the skill of the art is not enough to show that a claimed invention would have been obvious; what is required is a reason to modify the prior art as required by the claims. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Appeal 2011-009032 Application 10/593,376 8 Thus, we reverse the rejection of independent claim 1 and dependent claims 3, 4 and 12-16. Independent claim 22 is directed to a method that requires using a balloon having the same range of proximal working length- to-taper radius as recited in claim 1. Thus, we also reverse the rejection of independent claim 22 and dependent claims 24 and 25 for the reasons discussed above. SUMMARY We reverse the rejection of claims 1, 3, 4, 12-16, 22, 24, and 25 under 35 U.S.C. § 103(a). REVERSED lp