Ex Parte Case et al

Patent Trial and Appeal BoardAug 18, 2017

13444238 (P.T.A.B. Aug. 18, 2017)

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. 13/444,238 04/11/2012 Brian C. Case 1000-471 4418 42715 7590 08/22/2017 Buchanan Van Tuinen LLC P.O. Box 700 Perrysburg, OH 43552 EXAMINER SCHALL, MATTHEW WAYNE ART UNIT PAPER NUMBER 3738 NOTIFICATION DATE DELIVERY MODE 08/22/2017 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): u spto @ ipbyb v .com pair@ipbybv.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRIAN C. CASE, JACOB A. FLAGLE, MICHAEL L. GARRISON, ANDREW K. HOFF A, and RAY LEONARD II Appeal 2015-003649 Application 13/444,238 Technology Center 3700 Before PATRICK R. SCANLON, BEVERLY M. BUNTING, and GORDON D. KINDER, Administrative Patent Judges. SCANLON, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Brian C. Case et al. (“Appellants”)1 seek our review under 35 U.S.C. § 134 of the Examiner’s decision, as set forth in the Final Office Action, dated February 28, 2014 (“Final Act.”), rejecting claims 38 and 39 under 35 U.S.C. § 103(a) as unpatentable over Dor (US 6,334,871 Bl, iss. Jan. 1, 2002) and Bailey (US 2001/0021872 Al, pub. Sept. 13, 2001). An oral 1 Appellants identify Cook Medical Technologies LLC as the real party in interest. Appeal Br. 3. Appeal 2015-003649 Application 13/444,238 hearing was conducted on June 13, 2017. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. CLAIMED SUBJECT MATTER Appellants’ claimed invention “relates to medical devices, more particularly to intraluminal prosthes[e]s, such as valves, stents, and the like, placed using external imaging methods.” Spec. 1,11. 2—3. Claim 38, reproduced below, is the sole independent claim and is representative of the claimed subject matter. 38. An expandable prosthesis placeable into a body lumen, the expandable prosthesis comprising: a support structure configured to engage the walls of the body lumen, the support structure having a cross-sectional profile that includes a first axis; an artificial valve attached to the support structure and comprising a pair of opposing leaflets that define an orifice, the orifice including a first end and a second end located about the first axis; and a first radiopaque member located about the first end of the orifice and a second radiopaque member located about the second end of the orifice, each of the first radiopaque member and the second radiopaque member configured to facilitate visual identification of the rotational orientation of the first axis and the orifice while the prosthesis is being imaged externally; wherein the artificial valve opens and closes in response to fluid flowing therethrough. Appeal Br. 11, Claims App. 2 Appeal 2015-003649 Application 13/444,238 ANALYSIS In rejecting claims 38 and 39, the Examiner finds that “Dor discloses in figure 7 a stent comprising a support structure (1) with apertures and radiopaque markers (13) with larger end diameters within the apertures,” but concedes that “Dor does not disclose a valve in the stent.” Final Act. 3. The Examiner then finds that Bailey discloses a radiopaque stent having a valve and concludes that it would have obvious to one of ordinary skill in the art to provide the stent of Dor with a valve per the teaching of Bailey “in order to treat a diseased valve.” Id. Appellants argue that “Dor only describes the placement of a marker having radiopaque qualities within an opening defined by a circumferential wall of a stent,” and Bailey “lacks any mention of the required relative positioning between first and second radiopaque members and an orifice defined by a pair of opposing leaflets.” Appeal Br. 6. In response, the Examiner states that “[t]he claim language simply requires a radiopaque marker at each end of the device.” Ans. 2. It is not clear, however, what is meant by the Examiner’s reference to “the device.” Claim 38 recites an expandable prosthesis comprising a support structure, an artificial valve, and two radiopaque members. Presumably, “the device” refers to the expandable prosthesis, or perhaps the support structure or the artificial valve. In any case, the Examiner’s statement is not accurate. Claim 38 requires an artificial valve that comprises a pair of opposing leaflets that define an orifice having first and second ends, and a radiopaque member located at each end of the orifice. In other words, the claim language requires a radiopaque member to be located at each end of an orifice that is defined by a pair of opposing leaflets in an artificial valve. 3 Appeal 2015-003649 Application 13/444,238 This claim language requires much more than merely a radiopaque marker at each end of the device, regardless of whether “the device” refers to the expandable prosthesis, the support structure, or the artificial valve. Although relying on Bailey for disclosing a valve in a radiopaque stent (Final Act. 3), the Examiner fails to identify where Bailey discloses an artificial valve that comprises a pair of opposing leaflets that define an orifice having first and second ends. More importantly, even assuming arguendo that Bailey discloses such a valve, the Examiner does not explain adequately why one of ordinary skill in the art, when modifying the stent of Dor to include Bailey’s valve as proposed by the Examiner, would place a radiopaque member at each end of the valve orifice. Dor discloses inserting a radiopaque marker in opening 2 at each end or edge of stent structure 1 to mark the ends of the stent. Dor, 3:1—10. Bailey discloses providing radiopaque markers only on stent body member 12, rather than any valve structure. Bailey | 55. Thus, the prior art relied on by the Examiner does not teach or suggest positioning a radiopaque member at each end of an artificial valve orifice, as the Examiner suggests. Furthermore, the Examiner determines that the claimed first axis “can be either longitudinal or transverse, or any other angle and will be included in the cross-sectional profile.” Ans. 2. The problem with this reasoning, however, is the Examiner fails to identify an axis of the Dor-Bailey combination that purportedly corresponds to the first axis. The Examiner also fails to explain adequately why one of ordinary skill in the art, when making the proposed modification, would position the first and second ends of the valve orifice about the first axis, as required by claim 38. 4 Appeal 2015-003649 Application 13/444,238 For the above reasons, we do not sustain the rejection of claims 38 and 39 as unpatentable over Dor and Bailey. DECISION We reverse the decision of the Examiner rejecting claims 38 and 39. REVERSED 5