Ex Parte Cheng et alDownload PDFPatent Trial and Appeal BoardJan 12, 201712052037 (P.T.A.B. Jan. 12, 2017) 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. 12/052,037 03/20/2008 Eric Cheng 05-01545US2 (4010/205) 1678 121974 7590 01/17/2017 K AC VINSKY DAISAK BLUNI PLLC America's Cup Building 50 Doaks Lane Marblehead, MA 01945 EXAMINER OSINSKI, BRADLEY JAMES ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 01/17/2017 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): bbonneville @ kdbfirm .com docketing @ kdbfirm. com ndeane @ kdbfirm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ERIC CHENG, JIANMIN LI, WEENA BUCAY-COUTO, SCOTT SANDERS, JAMES F. SCHUERMANN, and MIN-SHY AN SHEU Appeal 2015-005244 Application 12/052,037 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. PER CURIAM DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a urological medical device for release of therapeutic agents. The Examiner rejected the claims on the ground of obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Boston Scientific Scimed, Inc. (see App. Br. 3). Appeal 2015-005244 Application 12/052,037 Statement of the Case Background Appellants’ “invention relates generally to urological medical devices, and more particularly to implantable or insertable urological medical devices which release therapeutic agents” (Spec. 12). The Claims Claims 1—6, 8, 12—14, 16—27, and 50-59 are on appeal. Independent claim 1 is representative and reads as follows (emphasis added): 1. A urological medical device comprising an alpha- adrenergic blocker as a urologically beneficial agent, said urological medical device being a ureteral stent adapted for placement in a urinary tract of a subject whereupon at least a portion of said urologically beneficial agent is released in vivo in an amount effective to promote kidney stone expulsion. The Issues A. The Examiner rejected claims 1—6, 8, 12, 14, 16—23, 26, 50, 51, 53, 54, and 56—59 under 35 U.S.C. § 103(a) as obvious over Fischer2 (Ans. 2-4). B. The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as obvious over Fischer and Price3 (Ans. 4). C. The Examiner rejected claim 24 under 35 U.S.C. § 103(a) as obvious over Fischer and Liu4 (Ans. 5). D. The Examiner rejected claims 25, 27, 52, and 55 under 35 U.S.C. § 103(a) as obvious over Fischer and Lawin5 (Ans. 5—6). 2 Fischer, Jr. et al., US 2007/0161967 Al, published July 12, 2007 (“Fischer”). 3 Price et al., US 2005/0074448 Al, published Apr. 7, 2005 (“Price”). 4 Liu et al., US 2004/0143209 Al, published July 22, 2004 (“Liu”). 5 Lawin et al., US 2003/0232087 Al, published Dec. 18, 2003 (“Lawin”). 2 Appeal 2015-005244 Application 12/052,037 Because the same issue is dispositive for all four rejections, we will consider them together. Appellants do not argue the claims separately, and we select claim 1 as representative. The Examiner finds that Fischer teaches a ureteral stent (several types, ]fs 43 & 55) comprising an alpha-adrenergic blocker (167) as a beneficial agent, wherein the ureteral stent is adapted for placement in the ureters, which are in the urinary tract of a subject, whereupon at least a portion of the beneficial agent is released in vivo in an amount to promote kidney stone expulsion (167, relaxes blood vessels, used in the urinary tract). (Ans. 2.) The Examiner acknowledges that Fischer “does not disclose a specific embodiment where a ureteral stent uses alpha-blockers” but finds “Fischer does disclose use of a ureteral stent (which is placed in the urinary tract) and alpha blockers used in the urinary tract to enhance urinary flow” {id.). The Examiner concludes that it would have been obvious to “utilize alpha blockers with a ureteral stent to enhance urinary flow (which also promotes kidney stone expulsion as the relaxed smooth muscle allows the kidney stone to pass easier)” {id. at 2—3). The issues with respect to these rejections are: Does the evidence of record support the Examiner’s conclusion that Fischer renders the claims prima facie obvious? Findings of Fact 1. Fischer teaches “a ureteral stent which contains channels, for example, an open pore structure,” the “channels containing a pharmacologically active ingredient in the central, linear portion” so that 3 Appeal 2015-005244 Application 12/052,037 “only the length of the ureter into which region 63 of stent 60 is placed will be treated with a pharmacologically active ingredient” (Fischer | 55; see also Ans. 2). 2. Fischer teaches that pharmacologically active ingredients may also be used in various embodiments. Alpha-blockers are drugs that block receptors in arteries and smooth muscles. The action of the alpha-blocker relaxes blood vessels and leads to an increase in blood flow and a lower blood pressure, thus helping to control blood pressure or hyper tension. In the bladder neck or urinary tract, alpha-blockers also relax the walls of the tract and enhance urinary flow, especially in persons suffering from prostatic hypertrophy (an enlarged prostate gland). Alpha-blocker drugs include doxazosin (CARDURA®), alfuzosin (UROXATRAL®), tamsulosin (FLOMAX®), prazosin (MINIPRESS®), and terazosin (HYTRIN®). (Fischer | 67; see also Ans. 2.) Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. Id. at 421. 4 Appeal 2015-005244 Application 12/052,037 Analysis We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 2—8; FF 1—2) and agree that claim 1 would have been obvious over Fischer. We address below Appellants’ arguments. Appellants contend that “[t]o arrive at the invention as presently claimed in independent claims 1 and 59, one of ordinary skill in the art would have to, inter alia, choose a ureteral stent from the numerous devices described in Fis[c]her” (App. Br. 7). Appellants also argue that one of ordinary skill in the art would have to have some reason to select an alpha-adrenergic blocker (e.g., tamsulosin or a pharmaceutically effective salt thereof) from among “[a] vast range of drugs, medicaments and materials [that] may be employed as a pharmacologically active ingredient. . .” (see paragraph [0057]) for use with the ureteral stent. {Id.) Appellants also contend that “one of ordinary skill in the art would have to release the alpha-adrenergic blocker in vivo in an amount effective to promote kidney stone expulsion, even though Fischer is completely silent regarding kidney stones” {id. at 7—8). Appellants argue that “the presently claimed invention would not have been obvious without the hindsight gained from Applicant’s disclosure” {id. at 9; see also Reply Br. 7). We find these arguments unpersuasive. As the Examiner explains, [Regarding choosing a stent from among the numerous devices described in Fis[c]her — Fis[c]her spends an entire paragraph (155) on ureteral stents, it is not part of a long list of items. Regarding selecting alpha-adrenergic blockers from a vast range, alpha blockers are explicitly disclosed for use in 5 Appeal 2015-005244 Application 12/052,037 the urinary tract (167), and one with ordinary skill in the art would be aware that ureters are part of the urinary tract. Regarding the amount, Fis[c]her discloses using alpha blockers in the urinary tract to relax smooth muscle to increase urinary flow (167), a side effect of said increased flow is the promotion of kidney stone expulsion. (Ans. 6; see also FF 1—2.) See KSR, 550 U.S. at 421. We further note that claim 1 does not define “an amount effective” rendering this phrase a functional recitation without any specific requirement. “‘Functional’ terminology may render a claim quite broad. By its own literal terms a claim employing such language covers any and all embodiments which perform the recited function.” In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). Therefore, “[i]f the prior art structure is capable of performing the intended use, then it meets the claim.” Id.. Here, Appellants have provided no evidence that the device rendered obvious by Fischer would not satisfy this functional recitation. Appellants contend that “without reference to Applicant’s disclosure, one of ordinary skill in the art would have had no motivation to provide a medical device as claimed” (App. Br. 8). We find this argument unpersuasive because Fischer provides reasons to administer alpha blockers to the urinary tract (FF 2) and Fischer provides reasons to use a ureteral stent to deliver drug only to desired locations (FF 1). Thus, the ordinary artisan, interested in delivering alpha blockers only to specific locations in the ureter, would have had reason to use a ureteral stent, both elements specifically taught by Fischer (FF 1—2). That the prior art has a different reason or motivation to combine is of no moment as long as there is a sufficient reason to make the combination. See In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996) (“[T]he motivation in the prior art to combine 6 Appeal 2015-005244 Application 12/052,037 the references does not have to be identical to that of the applicant to establish obviousness.”) Appellants argue that [b]ased on the Declaration of Jianmin Li submitted August 21, 2013, Applicant had previously argued that one of ordinary skill in the art would not use a ureteral stent to release an alpha blocker-drug based on the teachings of Fischer, Price, Liu and Lawin. In this regard, Applicant had argued, inter alia, that it is not at all apparent that local administration of alpha-blockers in the urinary tract would be an effective technique for relaxing the muscular portion of the prostate and/or the bladder neck, as opposed, for example, to systemic admiration by injection, oral administration, etc., and that, even assuming for the sake of argument that a person of ordinary skill in the art wished to locally administer an alpha-blocker to the urinary tract in order to relax the muscular portion of the prostate and/or the bladder neck, such a person would not elect to release the drug in the ureter. (App. Br. 8). We have considered the Li Declaration6 7but find it solely focused on Dr. Li’s “opinion that one of ordinary skill in the art would not use a ureteral stent to release an alpha blocker-drug” (Li Declaration 3). The Li Declaration provides no factual evidence, other than the opinion of the inventor, that addresses Examiner’s finding that it would have been obvious to include alpha blocker in a ureteral stent “to relax the urinary tract (which includes the ureters) to allow for increased flow” as taught by Fischer and that “[promoting kidney stone expulsion is a side effect of the relaxed urinary tract (including the ureters) which results in increased flow” (Ans. 8). 6 Declaration of Dr. Jianmin Li, dated July 29, 2013 (“Li Declaration”). 7 Appeal 2015-005244 Application 12/052,037 However, “the Board is entitled to weigh the declarations and conclude that the lack of factual corroborations warrants discounting the opinions expressed in the declarations.” In re Am. Acad. ofSci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). See also In re Bulina, 362 F.2d 555, 559 (CCPA 1966) (“[A]n affidavit by an applicant or co-applicant as to the advantages of his invention is less persuasive than one made by a disinterested person.”). Here, we acknowledge Dr. Li’s opinion, but find that it does not overcome the Examiner’s strong prima facie case of obviousness based substantively on the single Fischer reference teaching all of the elements of claim 1 and giving reasons to combine these elements (FF 1—2) as discussed by the Examiner (see Ans. 8). SUMMARY In summary, we affirm the rejection of claims 1 and 59 under 35 U.S.C. § 103(a) as obvious over Fischer. Claims 2—6, 8, 12, 14, 16—23, 26, 50, 51, 53, 54, and 56—58 fall with claim 1. We affirm the rejection of claim 13 under 35 U.S.C. § 103(a) as obvious over Fischer and Price. We affirm the rejection of claim 24 under 35 U.S.C. § 103(a) as obvious over Fischer and Liu. We affirm the rejection of claims 25, 27, 52, and 55 under 35 U.S.C. § 103(a) as obvious over Fischer and Lawin. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 8 Copy with citationCopy as parenthetical citation