Ex Parte Akingba et alDownload PDFPatent Trials and Appeals BoardApr 9, 201914228414 - (D) (P.T.A.B. Apr. 9, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/228,414 03/28/2014 26710 7590 04/11/2019 QUARLES & BRADYLLP Attn: IP Docket 411 E. WISCONSIN A VENUE SUITE 2350 MILWAUKEE, WI 53202-4426 UNITED ST A TES OF AMERICA FIRST NAMED INVENTOR A. George Akingba 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 144578.00090.IURTC11012 6672 EXAMINER GANESAN, SUBA ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 04/11/2019 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): pat-dept@quarles.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte A. GEORGE AKINGBA and RAGHU L. MOTAGANAHALLI 1 Appeal2017-011516 Application 14/228,414 Technology Center 3700 Before TA WEN CHANG, RACHEL H. TOWNSEND, and DAVID COTTA, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a modular stent assembly, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. STATEMENT OF THE CASE According to the Specification, [ w ]hile a number of types of endovascular stents have been conceived, there is still a need for new and improved designs. In one aspect, there is a need for a stent or stent 1 Appellants identify the Real Party in Interest as Indiana University Research & Technology Corporation. (Appeal Br. 2.) Appeal2017-011516 Application 14/228,414 assembly that can be deployed at the intersection of one or more arterial passages. In another aspect, there is a need for a set of modular stents that may be adjusted or assembled in myriad ways to accommodate vanous geometries and angles within an arterial space. (Spec. ,r 5.) Claims 1-9 are on appeal. Claim 1 is illustrative and reproduced below: 1. A modular stent assembly for deployment within a lumen, the modular stent assembly comprising: a trunk stent including: an expandable body defining an interior space, the body extending between an open proximal end and an open distal end; a graft material disposed on the body; an aperture positioned between the proximal end and the distal end, the aperture being formed through the body and the graft material; a trumpet stent including: an expandable body extending between an open first end and an open second end, an outer perimeter of the first end being greater than an outer perimeter of the second end, the trumpet stent further including a flared lip having a gradually increasing diameter; a graft material disposed on the body; and a securement stent including an expandable body extending between an open proximal end and an open distal end of the securement stent, wherein the body of the trumpet stent passes through the aperture of the trunk stent, the first end of the trumpet stent positioned at least partially within the interior space of the trunk stent, wherein the securement stent is positioned within the interior space of the trunk stent, and wherein an outer wall of the securement stent contacts an inner wall of the trunk stent and the first end of the trumpet stent, sandwiching the flared lip of the trumpet stent between 2 Appeal2017-011516 Application 14/228,414 the securement stent and the trunk stent, thereby coupling the trumpet stent to the trunk stent. (Appeal Br. 9-10 (Claims App'x).) The Examiner rejects claims 1-8 under 35 U.S.C. § 103 as being unpatentable over Brown2 and Wholey. 3 (Ans. 2.) The Examiner rejects claim 9 under 35 U.S.C. § 103 as being unpatentable over Brown, Wholey, and Yu. 4 (Ans. 6.) DISCUSSION Issue The Examiner has rejected claims 1-8 as obvious over Brown and Wholey. The Examiner has rejected claim 9 as obvious over Brown, Wholey, and Yu. The same issues are dispositive for both rejections, and we therefore discuss them together. The Examiner finds that Brown teaches all of the limitations of claim 1, except that Brown does not disclose a trumpet stent "with an outer perimeter of the first end being greater than an outer perimeter of the second end, the trumpet stent further including a flared lip having a gradually increasing diameter," and likewise does not specify that "an outer wall of the securement stent contacts the first end of the trumpet stent, sandwiching the flared lip of the trumpet stent between the securement stent and the trunk stent, thereby coupling the trumpet stent to the trunk stent." (Ans. 2-3, 4.) The Examiner finds, however, that Wholey teaches "a side branch stent with a larger outer perimeter on one end, further including a flared lip 2 Brown et al., US 2007/0055362 Al, published Mar. 8, 2007. 3 Wholey et al., US 2007/0173921 Al, published July 26, 2007. 4 Yu, US 2008/0114444 Al, published May 15, 2008. 3 Appeal2017-011516 Application 14/228,414 having a gradually increasing diameter ... for the purpose of engaging the main vessel prosthesis secure the stent and to provide a substantially smooth transition with a branch body lumen." (Id. at 3--4.) The Examiner concludes that [i]t would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the branch stent of Brown with an outer perimeter of the first end being greater than an outer perimeter of the second end and with a flared lip having a gradually increasing diameter as taught by Wholey as an obvious alternate side branch stent design that desirably engages and secures the side branch stent to the main prosthesis while providing a smooth transition with a branch lumen. This modification would have occurred using known methods and would have yielded predictable results to one of ordinary skill in the art at the time the invention was filed. (Id. at 4.) The Examiner further finds, with respect to the limitations in the last wherein clause of claim 1 (i.e., "wherein an outer wall of the securement stent contacts ... the first end of the trumpet stent, sandwiching the flared lip of the trumpet stent between the securement stent and the trunk stent, thereby coupling the trumpet stent to the trunk stent"), that "the prior art includes all the claimed structural components" and is merely silent "as to the specific order that the prosthesis components are assembled." (Id.) The Examiner concludes that it would have been obvious "to have provided the flared lip of the trumpet stent between the trunk stent and the securement stent as an obvious arrangement of the prior art components suitable for serving as a vascular prosthesis," in order to "further provide a smooth transition with a branch lumen." (Id.) The Examiner finds that such 4 Appeal2017-011516 Application 14/228,414 modification "would have occurred using known methods and would have yielded predictable results." (Id. at 4--5.) Appellants contend that the combination of cited prior art would not suggest to a skilled artisan a modular stent assembly "wherein an outer wall of [a] securement stent contacts an inner wall of [a] trunk stent and the first end of [a] trumpet stent, sandwiching the flared lip of the trumpet stent between the securement stent and the trunk stent, thereby coupling the trumpet stent to the trunk stent," as required by claim 1. (Appeal Br. 4--7; Reply Br. 2-3.) The issue with respect to this rejection is whether a preponderance of evidence of the record supports the Examiner's finding that the combination of Brown and Wholey suggests a modular stent assembly "wherein an outer wall of [a] securement stent contacts an inner wall of [a] trunk stent and the first end of [a] trumpet stent, sandwiching the flared lip of the trumpet stent between the securement stent and the trunk stent, thereby coupling the trumpet stent to the trunk stent." Analysis We agree with Appellants that the Examiner has not established a prima facie case that Brown and Wholey suggests a modular stent assembly "wherein an outer wall of [a] securement stent contacts an inner wall of [a] trunk stent and the first end of [a] trumpet stent, sandwiching the flared lip of the trumpet stent between the securement stent and the trunk stent, thereby coupling the trumpet stent to the trunk stent," as required by claim 1, the only independent claim. 5 Appeal2017-011516 Application 14/228,414 The Examiner first asserts that the prior art discloses all of the claimed structural components and that "[t]he difference between the prior art and the claim is that the prior art is silent as to the specific order that the prosthesis components are assembled." (Ans. 4.) We are not persuaded. The claims require a particular arrangement of the three structural components, i.e., the trunk stent, the trumpet stent, and the securement stent, wherein the flared lip of the trumpet stent is sandwiched between the trunk stent and the securement stent. Thus, the difference between the claims and the prior art is structural and not merely in the order in which the components are assembled. Notably, Brown teaches only two different stents, one inside the other. One of those stents can have a side branch structure that deploys in a petal like manner. (See, e.g., Brown ,r,r 13-14, 38-39.) Similarly, Wholey teaches two different stents, one that protrudes outwardly from inside the other. (See e.g., Wholey ,r,r 18, 86.) The Examiner asserts that, based on the combination of Brown and Wholey, it would have been obvious to provide a side branch stent graft with a flared lip that engages the inner surface of the Brown inner stent, as well as to provide a side branch stent graft with a flared lip that is sandwiched between the inner surface of the Brown outer stent and the outer surface of the Brown inner stent. Essentially, these are obvious means of combining a side branch stent graft as taught by Wholey with the double stent of Brown. (Ans. 7.) We are not persuaded. "[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal 6 Appeal2017-011516 Application 14/228,414 conclusion of obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Assuming that it would have been obvious to replace the side branch structure in Brown's overlapping stent with Wholey's flaring stent, the Examiner nevertheless has not provided persuasive reasons why it would have been obvious to provide a flared side branch stent where the flared lip of the stent is sandwiched between Brown's inner and outer stents, rather than having the flared lip of the side branch stent engage the inner surface of Brown's inner stent, as both Wholey and Brown teach (see e.g., Brown i-fl3 and Wholey ,r 18). The Examiner asserts that sandwiching the flared lip of the trumpet stent between the trunk stent and the securement stent is "an obvious arrangement of the prior art components suitable for serving as a vascular prosthesis." (Ans. 4.) In particular, the Examiner asserts that a skilled artisan would be motivated to adopt this arrangement of the stents "for the purpose of providing functional redundancy to the flared lip securement to ensure that it does not move, shift, or dislodge after implantation and long term implant use," and "to ensure a smooth transition between the side branch and the main lumen of the prosthesis" as taught by Wholey. (Id. at 7; see also id. at 4, 8.) The Examiner also asserts that a skilled artisan "would be motivated to sandwich the flared lip of the Wholey stent between the inner and outer stent of Brown to reinforce the junction between the side branch vessel and the main blood vessel." (Id. at 8.) The Examiner further asserts that "[t]his modification would have occurred using known methods 7 Appeal2017-011516 Application 14/228,414 and would have yielded predictable results to one of ordinary skill in the art at the time the invention was filed." (Id. at 4.) We are not persuaded. The Examiner does not provide persuasive evidence that Brown and/or Wholey suggest using the inner stent in Brown's overlapping stent for purposes of securing either the outer stent or a side branch stent. Neither does the Examiner explain how sandwiching the flared lip of a side branch stent between an inner and outer stent would "ensure a smooth transition between the side branch and the main lumen of the prosthesis." If anything, one would imagine this objective being better accomplished by having the flared lip of the side branch stent engage the inner surface of Brown's inner stent. Finally, while Brown explains that "[a]reas where structure of the main branch portion ... and side branch portion ... overlap ... desirably provide increased vessel coverage and support" (Brown ,r 79), the Examiner does not explain why the desirability of overlapping stents would suggest to a skilled artisan that Wholey's flaring stent should be sandwiched between Brown's inner and outer stents as opposed to, e.g., engaging the inner surface of Brown's inner stent-the engagement taught by both Brown and Wholey, as discussed above. The Examiner asserts that it is not "required when combining the teachings of Brown and Wholey to place the flared lip against the inner surface of the inner stent" merely "because Wholey stent's flared lip is meant to hold the stent graft to a vessel wall." ( Ans. 7.) The Examiner asserts that "Wholey's trumpet stent is fully capable of performing its securing and holding function equally well when positioned either within the trunk stent or within the securement stent" and that "the structure of Brown's inner stent is fully capable of serving the function of holding a 8 Appeal2017-011516 Application 14/228,414 trumpet stent and a trunk stent by sandwiching the trumpet stent between the securement stent and the trunk stent." (Id. at 7; see also id. at 8.) The Examiner asserts that, by providing additional blood vessel support from within the lumen of the trunk stent, the Brown inner stent holds and secures the trunk stent. It would have been obvious to provide the securement stent with the holding and securing function for the trumpet stent based on the combination of a side branch stent graft as taught by Wholey with the double stent of Brown that would have been recognized by a person of ordinary skill in the art. (Id. at 8.) We are not persuaded. As discussed above, the Examiner has not cited persuasive evidence that the combination of Brown and Wholey would have suggested to a skilled artisan to use Brown's inner stent in a securement role, or, more specifically, to use the inner stent to secure a flaring side branch stent by sandwiching the flared lip of the side branch stent against the outer stent. The Examiner cites no persuasive evidence, for instance, that by "providing additional blood vessel support" Brown's inner stent is functioning to "hold[] and secure[] the [outer] stent." (Ans. 8.) In summary, the Examiner's conclusory statements do not provide sufficient "articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Accordingly, we reverse the Examiner's rejection of claim 1. We likewise reverse the Examiner's rejections of claims 2-9, which depend directly or indirectly from claim 1. 5 In re Fritch, 972 F.2d 1260, 1266 (Fed. 5 The Examiner rejects claim 9 as obvious over Brown, Wholey, and Yu. The Examiner cites Yu only for the teaching of "multiple trumpet stents 9 Appeal2017-011516 Application 14/228,414 Cir. 1992). "[D]ependent claims are nonobvious if the independent claims from which they depend are nonobvious." SUMMARY For the reasons above, we reverse the Examiner's decision rejecting claims 1-9. REVERSED passing through the same aperture on a trunk stent." (Ans. 6.) Thus, the Examiner's citation to Yu does not cure the deficiency in the prima facie case with respect to the limitation "wherein an outer wall of the securement stent contacts an inner wall of the trunk stent and the first end of the trumpet stent, sandwiching the flared lip of the trumpet stent between the securement stent and the trunk stent, thereby coupling the trumpet stent to the trunk stent." 10 Copy with citationCopy as parenthetical citation