11781924 (P.T.A.B. Nov. 19, 2013)

Ex Parte Ho

Patent Trial and Appeal BoardNov 19, 2013

11781924 (P.T.A.B. Nov. 19, 2013)

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. 11/781,924 07/23/2007 Paul C. Ho 41505-703.201 6670 21971 7590 11/19/2013 WILSON, SONSINI, GOODRICH & ROSATI 650 PAGE MILL ROAD PALO ALTO, CA 94304-1050 EXAMINER TYSON, MELANIE RUANO ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 11/19/2013 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 PAUL C. HO ____________ Appeal 2012-002652 Application 11/781,924 Technology Center 3700 ____________ Before DONALD E. ADAMS, LORA M. GREEN, and MELANIE L. McCOLLUM, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134 involves claims 1 and 6-11 (App. Br. 3). Examiner entered a rejection under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The claims are directed to a temporary aortic valve for replacement in an ascending aorta of an adult patient to facilitate percutaneous aortic valve replacement. Claim 1 is representative and is reproduced in the Claims Appendix of Appellant’s Brief. 1 The Real Party in Interest is HOCOR Cardiovascular Technologies LLC (App. Br. 3). Appeal 2012-002652 Application 11/781,924 2 Claims 1 and 6-11 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Liprie.2 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Appellant’s Figures 1 and 2 are reproduced below: Illustrated in Fig. 1 in cross section and Fig. 2 in side view is the temporary aortic valve (TAV) 10 of [Appellant’s] … invention…. TAV 10 is comprised of three elongated supporting-balloons 12 of equal shape and size, contiguously arranged in parallel around a central guiding-catheter mechanism 14. TAV 10 is placed within the ascending aorta 20 by means of catheter 14, and then … [o]nce in position, supporting balloons 12 are inflated such that TAV 10 is lodged firmly against the inside walls 26 of ascending aorta 20. … The gaps 16 shown shaded in FIG. 1, between the supporting balloons 12 and inside aortic wall 26, allow limited blood flow, creating temporary effective aortic insufficiency (AI) and aortic stenosis (AS). As explained below, the temporary AI (during diastole) and AS (during systole) thus 2 Liprie, US 6,234,952 B1, issued May 22, 2001. Appeal 2012-002652 Application 11/781,924 3 created are deliberately designed to serve important functions during the percutaneous aortic valve (PAV) implant procedure. (Spec. 6: ¶¶ [0024]-[0025] and [0027] (as amended August 5, 2010 (alteration original)).) FF 2. According to Appellant Well documented physiologic significant AI begins at > 60% of the cross-sectional area of aortic annulus 32, as measurable by Doppler echocardiography in the parasternal short-axis view [Zobhbi WA, et al., J Am Soc. Echocardiogr 2003; 16:789]. Assuming application of TAV 10 positioned and deployed within ascending aorta 20 as shown, the calculated effective AI of 35% is categorized as moderate range in severity and should be well-tolerated by the patient even if it occurs acutely, e.g., after complete ablation of native aortic valve 30. Clinical significant AS is considered when the aortic valve area (AVA) is reduced to below 25% of its original cross- sectional area [Carabello B, N Engl J Med 2002;346(9):677- 682]. For example, a normal adult aortic orifice area is approximately 3 cm2, and a calculated AVA of less than 0.75 cm2 is considered significant. The calculated effective AS of TAV 10 of 35% falls within the moderate range, and should be an improvement from the patient’s original condition of critical native aortic stenosis and should be well-tolerated. (Id. at ¶¶ [0035]-[0036].) FF 3. Liprie suggests An apparatus and method for treating an occlusion or constriction, such as a stenosis in a blood vessel or other conduit in the body, as well as an apparatus and method for treating a tumor or cancerous area occurring around a conduit or duct in the body. The apparatus includes a catheter provided with a centering balloon including a catheter centering balloon encircling a portion of the catheter near its distal end. (Liprie, Abstract.) Appeal 2012-002652 Application 11/781,924 4 FF 4. Liprie’s Figure 5 is reproduced below: “FIG. 5 is [a] transverse cross-sectional view of an inflated multi-lobed dilatation balloon catheter,” wherein “dilatation balloon 14 provided with its four lobes 36, 38, 40 and 42 [are] in the inflated state” (Liprie, col. 4, ll. 27- 28; col. 5, ll. 46-48). “FIG. 5 also shows a multi-lobed centering balloon 41 having four lobes 44, 46, 48 and 50 in its deflated state” (id. at col. 5, ll. 50- 51). FF 5. Liprie suggests that “[w]hen the dilatation balloon 14 is deflated and the centering balloon 41 is inflated, only approximately 30-50% of the passageway would be blocked, thus allowing for bodily fluids to easily perfuse by” (id. at col. 6, ll. 1-4). ANALYSIS Based on Liprie, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious [T]o modify the size of the fully expanded balloons such that the gaps fall within a range of between 25% and 60% of the cross sectional area of the aortic valve area, or have a cross- sectional area of at least 0.75 cm2, since it has been held that where the general conditions are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Such a modification would enable the device to be utilized efficiently in larger bodily conduits. (Ans. 5; see also Ans. 6.) We are not persuaded. Appeal 2012-002652 Application 11/781,924 5 Appellant’s claimed invention is directed to a temporary aortic valve and requires, inter alia, that the cross-sectional area of the gaps, left by the occluding means when fully expanded, falls within a range of between 25% and 60% of the cross-sectional area of the aortic valve area (see Appellant’s claim 1).3 Notwithstanding Examiner’s assertion that it would have been obvious to simply modify the working range of Liprie’s balloons to permit Liprie’s device to be utilized efficiently in larger bodily conduits, Appellant’s Specification discloses that gaps created “between the supporting balloons 12 and inside aortic wall 26, allow limited blood flow … [and] are deliberately designed to serve important functions during the percutaneous aortic valve (PAV) implant procedure” (FF 1; see also FF 2). Stated differently, the range required by Appellant’s claim is deliberately designed to serve important functions as a temporary aortic valve. Examiner makes no finding on this record to support a conclusion that Liprie recognized that a change to the cross-sectional area of the gaps left by the occluding means (i.e. balloons) when fully expanded would serve the disclosed functions, when used as a temporary aortic valve during a percutaneous aortic valve implant procedure (Cf. Appellant’s claim 1 and FF 1-2; see App. Br. 6-7). Therefore, we agree with Appellant that the Examiner has not provided adequate support for the conclusion that it would have been obvious to modify the device to be used in the area of the aortic valve (App. Br. 6 & Reply Br. 3-4). We also agree with Appellant’s contention that Examiner has not set forth a prima facie case that Liprie discloses that the cross-sectional area of the gaps left by the occluding 3 Claims 6-11 depend directly or indirectly from claim 1. Appeal 2012-002652 Application 11/781,924 6 means when fully expanded falls within a range of between 25% and 60% of the cross sectional area of the aortic valve area. CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1 and 6-11 under 35 U.S.C. § 103(a) as unpatentable over Liprie is reversed. REVERSED cdc