Ex Parte Feld et al

Patent Trial and Appeal BoardMar 18, 2015

12390202 (P.T.A.B. Mar. 18, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte TANHUM FELD and EITAN KONSTANTINO __________ Appeal 2012-007788 Application 12/390,202 Technology Center 3700 __________ Before DEMETRA J. MILLS, ERIC B. GRIMES, and LORA M. GREEN, Administrative Patent Judges. PER CURIAM. DECISION ON APPEAL This is a decision on appeal 1 under 35 U.S.C. § 134 from the Examiner’s rejection of claims 1–4, 6–8, and 11–17. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The Specification discloses “methods and devices for the placement of a stent in a bifurcation or ostial lesion” (Spec. 3 ¶ 14). The Specification discloses that a “balloon expandable stent is designed to expand and support 1 The Real Party in Interest is TriReme Medical, Inc. (App. Br. 3). Appeal 2012-007788 Application 12/390,202 2 the main vessel while a flaring portion is designed to open into and support a side branch vessel and/or bifurcation ostium area” (id. at 4 ¶ 15). Claim 1, the only independent claim, is representative of the claims on appeal and reads as follows: 1. An expandable stent for deployment at a vascular bifurcation having a side vessel branching from a main vessel, the stent comprising: a main body for expansion into the main vessel, wherein the main body has an outer surface and a main body axis; and a flaring portion disposed on one side of the outer surface of the main body and adapted to flare radially outwardly from the one side of the outer surface relative to the main body axis in response to expansion of the main body; wherein the flaring portion is on said one side only of said outer surface and the flaring portion consists of one distal wing and one proximal wing each aligned along the axis of the main body, and wherein the proximal wing is longer than the distal wing. Issue The Examiner has rejected claims 1–4, 6–8, 12–14, and 17 under 35 U.S.C. § 103(a) as obvious over the combination of Loos, 2 Eidenschink, 3 and Davidson ’352 4 (Ans. 5–8). The Examiner has also rejected, under 35 U.S.C. § 103(a), claim 11 over the combination of Loos, Eidenschink, Davidson ’352, and Davidson ’268 5 (Ans. 9) and claims 15 and 16 over the 2 Loos et al., US 6,579,309 B1, issued June 17, 2003 (hereinafter “Loos”). 3 Eidenschink, US 2004/0088007 A1, published May 6, 2004 (hereinafter “Eidenschink”). 4 Davidson ’352 et al., US 2004/0267352 A1, published Dec. 30, 2004 (hereinafter “Davidson ’352”). 5 Davidson ’268 et al., US 2004/0133268 A1, published July 8, 2004 (hereinafter “Davidson ’268). Appeal 2012-007788 Application 12/390,202 3 combination of Loos, Eidenschink, Davidson ’352, and Majercak 6 (Ans. 9– 10). We focus our analysis on independent claim 1. The issue presented is: Has the Examiner established by a preponderance of the evidence that the combination of Loos, Eidenschink, and Davidson ’352 would have made obvious an expandable stent comprising a main body and a flaring portion disposed on one side of the outer surface of the main body, wherein the flaring portion “consists of one distal wing and one proximal wing,” as required by claim 1? Findings of Fact FF1. The Examiner finds that Loos discloses “a balloon expandable stent . . . for deployment at a vascular bifurcation having a side vessel branching from a main vessel” (Ans. 5 (citing Loos, Fig. 1)). FF2. The Examiner finds that Loos’ stent comprises “a main body (2) for expansion into the main vessel . . . and a flaring portion (5) disposed on a side of the main body and adapted to flare radially and offset the main body axis” (id.). FF3. The Examiner finds that, in Loos, “the flaring portion comprises only one distal wing (7) and only one proximal wing (6) each aligned along the axis of the main body” (id. (citing Loos, Fig. 1)). FF4. The Examiner finds that “the wings are configured to open . . . when the flaring portion flares radially into the side branch vessel” (id. (citing Loos, Fig. 1)). 6 Majercak et al., US 2005/0288771 A1, published Dec. 29, 2005 (hereinafter “Majercak”). Appeal 2012-007788 Application 12/390,202 4 FF5. The Examiner finds that the Loos “flaring portion is adapted to flare radially and offset the main body axis in response to expansion of the main body” of the stent (id. at 6 (citing Loos, col. 5, ll. 60–64)). FF6. Loos discloses a “stent for implantation in the region of vessel branching” (Loos, col. 1, ll. 11–14). FF7. Figure 1 of Loos is shown below: Figure 1 shows a diagram of Loos’ stent implanted in a blood vessel (id. at col. 4, ll. 53–56). FF8. Loos discloses that the “stent 1 has a branching portion 5 which . . . is arranged in the region of the vessel branching 4. To support the vessel transition 4, the branching portion 5 includes an elongated first support element 6 and an elongated second support element 7” (id. at col. 4, ll. 61– 65). FF9. Loos discloses that the “support elements 6 and 7 are curved radially out of the peripheral surface 2.3 into the branching-off branch 3.1 of the vessel by means of a first guide wire 8 of the balloon catheter 9” (id. at col. 5, ll. 10–15). Appeal 2012-007788 Application 12/390,202 5 FF10. Figure 2A of Loos is shown below: Figure 2A shows “a development of the casing 2 of the stent according to the invention as shown in FIG. 1, comprising a structure of bar-like or web- like elements” (id. at col. 5, ll. 31–33). FF11. Loos discloses that “the casing 2 has a number of branching portions 5 which are in mutually adjoining relationship in the peripheral direction of the casing” (id. at col. 5, ll. 34–36). FF12. Loos discloses that the “respective branching portion 5 includes a first support element 6, and a second support element 7 . . . and a respective third and fourth support elements 13 and 18 respectively which are arranged adjacent to the first and second support elements 6 and 7, respectively” (id. at col. 5, ll. 37–44). FF13. The Examiner finds that Loos “fails to disclose wherein the proximal wing is longer than the distal wing and wherein the flaring portion is disposed on only one side of the outer surface of the main body” (Ans. 6). FF14. The Examiner finds that “Eidenschink teaches a stent with a flaring portion disposed on only one side of the outer surface of the main body wherein the proximal wing (22) is longer than the distal wing [](21)” (id. (citing Eidenschink, Figs. 1 and 1a)). Appeal 2012-007788 Application 12/390,202 6 FF15. The Examiner concludes that “it would have been obvious to one of ordinary skill in the art . . . to modify the device of Loos wherein the proximal wing is longer than the distal wing . . . [in order] to provide better carina coverage, as disclosed by Eidenschink” (id. at 6–7 (citing Eidenschink ¶ 53)). FF16. The Examiner finds that Eidenschink does “not explicitly disclose[] that fingers (24) are connected to form only two wings” (id. at 7). FF17. The Examiner finds that Davidson ’352 discloses “a stent with a main body and a flaring portion disposed on only one side of the outer surface of the main body consisting of one distal wing and one proximal wing” (id. (citing Davidson ’352, Fig. 37)). FF18. Davidson ’352 discloses “a stent for use in a bifurcated body lumen having a main branch and a side branch” (Davidson ’352 ¶ 14). FF19. Davidson ’352 discloses that the stent “surface has a geometrical configuration defining a first pattern, and the first pattern has first pattern struts and connectors” (id.). FF20. Davidson ’352 discloses that the “stent also comprises a branch portion comprised of a second pattern, wherein the branch portion is at least partially detachable from the stent body” (id.). Appeal 2012-007788 Application 12/390,202 7 FF21. Figure 37 of Davidson ’352 is shown below: Figure 37 shows an “embodiment of a stent 280 . . . [that] includes lateral connecting members 282 that extend through space 246 and connect the outer ring 250 to struts 284 laterally outside branch portion 30” (id. at 8 ¶ 86). FF22. Figure 38 of Davidson ’352 is shown below: Figure 38 shows “a stent 290 . . . hat is similar to stent 280 . . . and generally includes at least one omega shaped connecting member 292” (id. at 8 ¶ 87). Appeal 2012-007788 Application 12/390,202 8 FF23. Figure 39 of Davidson ’352 is shown below: Figure 39 shows “a perspective view of the stent of FIG. 38 in the expanded configuration” (id. at 3 ¶ 0049). Analysis Appellants argue that the combination of the cited references “fail to teach or reasonably suggest the claimed ‘flaring portion’ that, inter alia, is on one side only of the outer surface of the main body of the stent and consists of one distal wing and one proximal wing” (App. Br. 10). Appellants argue that “Loos does not teach and even teaches away from a ‘flaring portion’ that is on one side only of the outer surface of the main body of the stent and consists of one distal wing and one proximal wing” (id. at 6). Appellants argue that, in Loos, there are “multiple pairs of such support elements equally circumferentially spaced about the cylindrical body of the stent” (id.). Appellants argue that Eidenschink discloses multiple fingers that “may flare radially outwardly from the tubular structure to support a blood vessel side branch” and therefore does not disclose a flaring portion that consists of one distal wing and one proximal wing (id. at 8). Appellants argue that Davidson ’352 discloses “a single, continuous tubular Appeal 2012-007788 Application 12/390,202 9 structure extending from the main body of the stent body 280” and does not disclose a flaring portion that consists of one distal wing and one proximal wing (id. at 9). Appellants argue that Figures 37–39 of Davidson ’352 show that a “branch portion 30 circumferentially supports an ostium as a single, continuous structure . . . [and therefore] fails to disclose a ‘flaring portion’ that ‘consists of one distal wing and one proximal wing’” (Reply Br. 2). The Examiner responds that Loos’ Figure 1 shows that “only a single portion is flared upon expansion on one side of the outer surface of the main body of the stent” (Ans. 10). The Examiner further responds that “only the support elements shown in the elliptical section II of Figure 2a are referenced as support elements 6 and 7, as these are the only support elements that flare radially” (id. at 11). The Examiner finds that Loos “discloses only one distal wing 7 and one proximal wing 6 . . . [and] neither Eidenschink nor Davidson ’352 needs to include this particular feature” (id.). The Examiner further responds that Davidson ’352 “also teaches only one distal wing and one proximal wing” (id. at 11 (citing Davidson ’352, Fig. 37)). We agree with the Appellants that the Examiner has not adequately explained how the combination of Loos, Eidenschink, and Davidson ’352 would have made obvious an expandable stent comprising a main body having a flaring portion disposed on one side of the outer surface that “consists of one distal wing and one proximal wing each aligned along the axis of the main body.” The Examiner relies on Figure 1 of Loos as disclosing a flaring portion that “consists of one distal wing and one proximal wing” (FF 3). The Examiner’s reliance on Loos is in error because Appeal 2012-007788 Application 12/390,202 10 Loos discloses that Figure 2a shows the casing of the stent of Figure 1 and Figure 2a shows pairs of proximal and distal support elements, e.g., 6, 7, 8, and 13, and thus does not disclose a flaring portion that consists of one distal wing and one proximal wing (FFs 10 and 12). The Examiner relies on Figure 37 of Davidson ’352 as disclosing a stent having a flaring portion that consists of one distal wing and one proximal wing (FF 17). The Examiner’s reliance on Figure 37 of Davidson ’352 is in error because the Examiner has not pointed to any text of Davidson ’352 as supporting this interpretation of Figure 37, and Figures 38–39 of Davidson ’352, which Davidson ’352 suggests are similar to Figure 37, show a circumferential support for the branching portion, rather than only one proximal wing and one distal wing (FFs 22 and 23). Thus, we reverse the rejection of independent claim 1 and claims 2–4, 6–8, 12–14, and 17 as being obvious over the combination of Loos, Eidenschink, and Davidson ’352. The Examiner has also rejected, under 35 U.S.C. § 103(a), claim 11 over the combination of Loos, Eidenschink, Davidson ’352, and Davidson ’268 (Ans. 9) and claims 15 and 16 over the combination of Loos, Eidenschink, Davidson ’352, and Majercak (Ans. 9–10). Claims 11, 15, and 16 depend from claim 1 directly or indirectly. For these rejections, the Examiner relies on Loos, Eidenschink, and Davidson ’352, as discussed above, and the Examiner relies on Majercak and Davidson ’268 only to supply dependent claim limitations. Thus, we also reverse these rejections for the reasons discussed above. Appeal 2012-007788 Application 12/390,202 11 Conclusion of Law The preponderance of the evidence does not support the Examiner’s conclusion that the combination of Loos, Eidenschink, and Davidson ’352 would have made obvious an expandable stent comprising a main body and a flaring portion disposed on one side of the outer surface of the main body, wherein the flaring portion “consists of one distal wing and one proximal wing,” as required by claim 1. SUMMARY We reverse the rejection of claims 1–4, 6–8, and 11–17 under 35 U.S.C. § 103(a). REVERSED cdc