Ex Parte KusleikaDownload PDFBoard of Patent Appeals and InterferencesJul 24, 201210825309 (B.P.A.I. Jul. 24, 2012) 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. 10/825,309 04/16/2004 Richard S. Kusleika 12013/48803 7747 23838 7590 07/25/2012 KENYON & KENYON LLP 1500 K STREET N.W. SUITE 700 WASHINGTON, DC 20005 EXAMINER VU, QUYNH-NHU HOANG ART UNIT PAPER NUMBER 3763 MAIL DATE DELIVERY MODE 07/25/2012 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte RICHARD S. KUSLEIKA __________ Appeal 2011-009358 Application 10/825,309 Technology Center 3700 __________ Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and ERICA A. FRANKLIN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a process for treating tissue at a treatment site with a body lumen. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 16-24, 38 and 39 are on appeal. Claim 1 is representative and reads as follows (emphasis added): Appeal 2011-009358 Application 10/825,309 2 1. A process for treating tissue at a treatment site within a body lumen, comprising: providing an elongate flexible catheter having a flexible treatment sheath mounted to a distal end region of the catheter and a dilatation balloon within the flexible treatment sheath, wherein the flexible treatment sheath is formed of an elastic material and the dilatation balloon is formed of a substantially inelastic material; intraluminally advancing the elongate flexible catheter until the flexible treatment sheath is adjacent a predetermined treatment site; while maintaining the dilatation balloon in an unexpanded condition, supplying a treatment fluid under pressure to a compartment formed by the treatment sheath, to elastically expand the treatment sheath radially into a substantially conforming contact with the surrounding tissue at the treatment site, cause the treatment fluid to pass through the treatment sheath from the compartment to the surrounding tissue, and maintain the treatment sheath expanded into said contact; and while maintaining the treatment sheath in said substantially conforming contact with the surrounding tissue at the treatment site, radially expanding the dilatation balloon within the compartment, whereby the dilatation balloon acts radially upon the surrounding tissue through the treatment sheath to effect a dilatation of the surrounding tissue. The Examiner rejected claims 16-24, 38 and 39 under 35 U.S.C. § 103(a) as unpatentable over Shockey 1 and Sogard. 2 The Examiner’s position is that Shockey disclosed a process for treating tissue at a treatment site within a body lumen, comprising providing an elongate flexible catheter having a flexible treatment sheath formed of an elastic material and a dilatation balloon. (Ans. 3.) The Examiner found that Shockey did not disclose that its dilatation balloon was formed of substantially inelastic materials. (Id.) The Examiner found that Sogard 1 US Patent No. 4,994,033 issued to Rick L. Shockey et al., Feb. 19, 1991. 2 US Patent No. 5,447,497 issued to David J. Sogard et al., Sep. 5, 1995. Appeal 2011-009358 Application 10/825,309 3 disclosed a device having an elongate flexible catheter with a flexible treatment (outer) sheath and a dilatation balloon made from inelastic materials such as rigid or stiff polymeric materials. (Id.) According to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to have modified Shockey’s device to include a dilatation balloon made of an inelastic material, as taught by Sogard, to dilate and prevent rupture of the balloon. (Id. at 4.) Appellant contends, among other things, that Shockey’s outer expander membrane, i.e., flexible treatment sheath, is not formed of an elastic material, as required by independent claim 16. (App. Br. 10.) Rather, Appellant asserts that Shockey’s sheath is substantially inelastic. (Id.) In support of this contention, Appellant asserts that the same materials that Shockey discloses for this outer member, i.e., polyethylene tetrathalate (PET) and polyvinyl chloride (PVC), are among the inelastic materials Appellant discloses in their Specification for their inelastic balloon. (Id. at 10-11)(citing Spec. [0045]). In the Response to Argument, the Examiner states that “[i]t is very well-known in the art that polyethylene tetrathalate [and] polyvinyl chloride [are] soft or elastic materials.” (Ans. 5.) In support of this statement, the Examiner notes that: (a) Sogard disclosed that examples of soft or flexible polymeric materials include thermoplastic elastomers, polyethylene, and PVC (id.); (b) the present Specification disclosed that the flexible treatment sheath is formed of an elastic biocompatible polymer, e.g., latex or other suitable materials such as polyurethane, silicon, and thermoplastic elastomers (id.)(citing Spec [0047]); and (c) additional prior art provides evidence that PVC is a thermoplastic elastomer (id. at 7-8). Appeal 2011-009358 Application 10/825,309 4 Appellant replies by citing rebuttal evidence which characterizes PET and PVC as “generally” and “relatively” inelastic material. (Reply Br. 3-4.) Appellant additionally replies with evidence indicating the modulus of elasticity for PET and PVC is on the order of 400,000 psi, whereas the Specification states that in the invention elastic material may have a relatively low “modulus of elasticity in the range of about 2,000 to 80,000 psi.” (Id.) After considering all the evidence and arguments, we conclude that the record does not support a conclusion of prima facie obviousness. Specifically, the Examiner relied on Shockey as disclosing a flexible treatment sheath formed of elastic material by teaching that the material may be PET or PVC. However, as the evidence submitted by Appellant confirms, these materials are not inherently elastic, but may also be generally inelastic. (See Reply Br. 3-5.) Shockey did not identify the elasticity characteristic of its materials or otherwise disclose such characteristic for its treatment sheath. Consequently, we find that the Examiner has not established that Shockey’s treatment sheath was necessarily formed of elastic material, as required by independent claim 16. Accordingly, we reverse the obviousness rejection of claims16-24, 38 and 39. REVERSED alw Copy with citationCopy as parenthetical citation