Ex Parte Stanford et alDownload PDFBoard of Patent Appeals and InterferencesFeb 2, 201210975851 (B.P.A.I. Feb. 2, 2012) 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. 10/975,851 10/28/2004 Ulf Harry Stanford 1001.1615102 5770 11050 7590 02/02/2012 SEAGER, TUFTE & WICKHEM, LLC 1221 Nicollet Avenue Suite 800 Minneapolis, MN 55403 EXAMINER TYSON, MELANIE RUANO ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 02/02/2012 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 BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte ULF HARRY STANFORD, YEM CHIN, SHENG-PING ZHONG and JOHN A. GRIEGO ____________ Appeal 2009-010642 Application 10/975,851 Technology Center 3700 ____________ Before JOHN C. KERINS, MICHAEL L. HOELTER and JAMES P. CALVE, Administrative Patent Judges. KERINS, Administrative Patent Judge. DECISION ON APPEAL Appeal 2009-010642 Application 10/975,851 2 STATEMENT OF THE CASE Ulf Harry Stanford et al. (Appellants) seek our review under 35 U.S.C. § 134 of the Examiner’s final rejection of claims 35, 36, 38, 40-42, 44, 45, 47, 48, 51-53 and 55-59. Claims 1-34, and 39 are canceled, and claims 37, 43, 46, 49, 50 and 54 are withdrawn from consideration. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. THE INVENTION Appellants’ invention is directed to a low profile emboli capture device. Claims 35 and 51, reproduced below, are illustrative: 35. A low profile emboli capture device comprising: a guidewire having a proximal end and a distal end; a filter disposed about a distal portion of the guidewire, the filter having a retracted position and an expanded position, the filter being adapted to capture emboli in its expanded position; a stent attached to the filter; and a sleeve extending over at least a portion of the filter in the retracted position, the sleeve infolded such as to form an inner layer and an outer layer, wherein the inner layer of the sleeve is secured to the guidewire. Appeal 2009-010642 Application 10/975,851 3 51. A low profile emboli capture device comprising: a guidewire having a proximal end, a distal end and a cross-sectional profile, the guidewire including a mounting region having a cross- sectional profile less than the guidewire cross- sectional profile; a filter disposed about at least a portion of the mounting region, the filter having a retracted position and an expanded position, wherein in the retracted position the filter has a cross-sectional profile approximately the same as the cross- sectional profile of the guidewire; a stent attached to the filter; and a sleeve disposed about at least a portion of the guidewire and slidable thereon, the sleeve including an inverted, double folded end portion extending over the filter, wherein the sleeve is movable between a first position for retaining the filter in the retracted position and a second position for releasing the filter in the expanded position, further wherein the inner layer of the sleeve is secured to the guidewire at a location proximal the mounting region. THE REJECTIONS The Examiner has rejected (i) claims 35, 36, 38, 40, 41, 44, 45, 47, 51-53 and 55-59 under 35 U.S.C. § 103(a) as being unpatentable over Green (US 6,485,501 B1, issued Nov. 26, 2002) in view of Yurek (US 5,690,644, issued Nov. 25, 1997); Appeal 2009-010642 Application 10/975,851 4 (ii) claim 42 under 35 U.S.C. § 103(a) as being unpatentable over Green, Yurek and Simon (US 4,425,908, issued Jan. 17, 1984); and (iii) claim 48 under 35 U.S.C. § 103(a) as being unpatentable over Green, Yurek and Ambrisco (US 6,007,557, issued Dec. 28, 1999). ISSUES Did the Examiner provide an articulated reason to combine the teachings of Green and Yurek that is supported by rational underpinnings? Did the Examiner err in finding that Green discloses a stent attached to a filter? Did the Examiner err in finding that Green discloses a guidewire that includes a distal mounting region having a cross-sectional profile less than the guidewire cross-sectional profile, with a filter disposed about at least a portion of the mounting region? ANALYSIS Claims 35, 36, 38, 40, 41, 44, 45, 47, 51-53 and 55-59--Green/Yurek Appellants argue claims 35, 36, 38, 40 and 47 as a group. We take claim 35 as representative. Appellants separately argue the patentability of claims 41, 44, and 45, which depend directly or indirectly from claim 35.1 Similarly, without identifying the claims in a separate subheading, Appellants separately argue the patentability of claim 51 grouped with claims 52, 53, and 55-59 depending therefrom. For this group of claims, claim 51 is deemed representative. 1 The claims are not identified in separate subheadings, as recommended by 37 C.F.R. § 41.37(c)(1)(vii), however we were able to discern which arguments were relevant to which claims. Appeal 2009-010642 Application 10/975,851 5 Appellants’ main arguments directed to claim 35 are that the Green patent does not disclose a stent that is attached to a filter (App. Br. 8-11; Reply Br. 3-6), that a person of ordinary skill in the art would not combine the teachings of Yurek with Green in the manner proposed (App. Br. 12-13; Reply Br. 8), and that Yurek does not disclose an infolded sleeve wherein a portion of the inner layer is secured to a guidewire (App. Br. 12). Taking the last of these contentions first, the Examiner maintains that the proposed modification to Green’s device is to provide Green’s sleeve in an infolded state (the infolded sleeve being taught by Yurek) such that the inner layer would be secured to the delivery device, or guidewire, of Green. (Ans. 6). We are not persuaded by Appellants’ argument, which is viewed as either an individual attack on the Yurek reference or improper insistence on an exact bodily incorporation of the teachings of Yurek into the Green device. Appellants’ argument that persons of ordinary skill in the art would not combine the teachings of Yurek and Green is based primarily on the contention that one does not need the additional layer of sleeve material that would result from employing an infolded sleeve as disclosed by Yurek on the device of Green in order to deploy Green’s filter, and that the additional sleeve thickness would result in an undesirably large delivery configuration. (Reply Br. 8). The first contention does not address the consideration that a person skilled in the art might wish to deploy the filter by peeling a flexible sleeve from over the filter (see Ans. 4) rather than extracting the filter through a more rigid sheath, as shown in Green. The latter contention presupposes that the material of the infolded sleeve would be at least as thick as the sheath disclosed in Green, whereas there is nothing to indicate that that would be the case. Furthermore, even if a larger delivery configuration Appeal 2009-010642 Application 10/975,851 6 would result, a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate any or all reasons to combine teachings. See Winner Int'l Royalty Corp. v. Wang, 202 F.3d 1340, 1349, n. 8 (Fed. Cir. 2000). Appellants’ arguments to the effect that Green does not disclose a stent attached to a filter will be addressed with reference to Appellants’ Specification. Appellants describe that an “expansion means” is provided, which, in its broadest sense, is “any device used to cause filter 60 to expand.” (Spec., p. 7, ll. 1-2). Appellants’ “preferred expansion means is a ‘self-expanding stent’”, with that term being used in the Specification and claims, “in its broadest sense as a plurality of arms which have a shape memory expanded position wherein they are capable of contacting arterial walls and supporting a filter such as filter 60 and which may be compressed or folded against the guidewire 20 by radial forces applied against the arms.” (Spec, p. 7, ll. 2-7). Appellants frame the issue as whether one of ordinary skill in the art would understand that wire ends 174, filter basket wires 168, membrane 170, and wire ends 172 of Green combine to form an art recognized filter as that term is commonly used or whether the elements would be understood to disclose or teach two distinct structures, said respective structures comprising a “stent”, . . . , and an attached filter. (Reply Br. 3-4). In the absence of Appellants’ Specification, the Answer might reasonably be the former. However, claim interpretation and application of prior art to claim elements must be done not in the absence of Appellants’ Specification, but instead in the context of Appellants’ Specification. Appeal 2009-010642 Application 10/975,851 7 Claim 35 calls for simply a “stent” attached to a “filter”. The claim term “stent” clearly encompasses the disclosed and broadly defined “self- expanding stent”, which is essentially a plurality of arms having certain material characteristics.2 Appellants’ structure as illustrated in Figure 2 has a plurality of expandable arms (a “self-expanding stent”) attached to a filter. The structure disclosed in Figures 14 and 15 of Green is much the same, and certainly includes a plurality of expanding arms (a “self-expanding stent”, as defined by Appellants) attached to a filter membrane. It is Appellants’ own description and definitions that informed the Examiner’s findings in this respect, and we fail to see error in the manner in which the Examiner has read claim 35 onto the Green structure. Accordingly, the rejection of claim 35, as well as that of claims 36, 38, 40 and 47, as unpatentable over Green and Yurek, is sustained. Appellants separately argue claim 41 essentially for the same reason advanced with respect to claim 35, i.e., that the Examiner erroneously found that the filter basket wires in Green comprise the claimed stent attached to a filter. For the reasons discussed above, we sustain the rejection of claim 41 as unpatentable over Green and Yurek. 2 Appellants’ argument (Reply Br. 4) to the effect that the Examiner’s reliance on the “stent” disclosed in Appellants’ Figure 2 is in error, because the embodiment of Figure 2 is directed to a non-elected species, is not well taken. Early on in prosecution, the Examiner identified, and Appellants acknowledged, that claim 35 now at issue was generic to all species. (Ofc. Action dated Jan. 30, 2007; Response to Restriction Requirement dated Feb. 21, 2007). Similarly, Appellants’ argument (id.) that the claimed “stent” is “not necessarily self-expanding” is misplaced, and actually is tantamount to an admission that the claim encompasses self-expanding stents, as defined in the Specification. Appeal 2009-010642 Application 10/975,851 8 Claim 44, which depends from claim 35, and independent claim 51, each contain a limitation that the guidewire include a mounting region proximal the distal end of the emboli capture device, with the mounting region having a cross-sectional profile which is less than the cross-sectional profile of the guidewire, and that the filter be disposed about at least a portion of the mounting region. (Appeal Br., Claims Appendix). Appellants contend that the Green device does not include such features, and that the Examiner’s reliance on two different embodiments in Green (one illustrated in Figures. 14, 15 and 17, another illustrated in Figures 1, 4, 5A and 12) as disclosing these elements is in error. (Appeal Br. 13-14; Reply Br. 7). We here agree with Appellants. The device illustrated in Figures 14, 15 and 17, principally relied on by the Examiner as disclosing most of the claim limitations, has a guidewire with a region of smaller cross-sectional dimension near a distal end of the device, but there is no indication that the filter in that embodiment would be disposed about a portion of that region, as required by the claims. The embodiments of the device illustrated in Figures 1, 4, 5A and 12, for example, do have a mounting region proximate the distal end, the cross- section of which is less than the cross-section of the guidewire. However, these embodiments operate in a different manner from the embodiment of Figures 14, 15 and 17. In particular, the latter embodiment employs radiopaque markers or crimp bands 176, 178, at least one of which is to be slidable over core wire 164, in order for the filter and stent to expand and contract. (Green, col. 7, ll. 58-67; Figs. 14, 15). Given that this embodiment is not illustrated as having a mounting portion of reduced cross-section about which the filter is disposed, and given Appeal 2009-010642 Application 10/975,851 9 that the transition from the reduced cross-section to the full cross-section of the guide wire would appear to impede or prohibit the sliding of the slidable crimp band, and further given the lack of any explanation by the Examiner as to how features from other embodiments could be employed in the embodiment of Figures 14, 15 and 17, we are persuaded that the Examiner’s findings in this respect are in error. The rejection of claim 44, of claim 45 depending from claim 44, and of independent claim 51 and claims 52, 53 and 55-59 depending therefrom, is not sustained. Claim 42--Green/Yurek/Simon Appellants argue that the Simon reference does not overcome the alleged deficiencies of Green, nor the alleged deficiencies of the combination of teachings of Green with Yurek. (App. Br. 16). Essentially all of the contentions are merely restatements of claim language found in claim 35, from which claim 42 depends. (Id.). As noted supra, the combination of teachings of Green and Yurek is not deficient with respect to the obviousness of the subject matter of claim 35. Accordingly, we are not persuaded that the Examiner erred in concluding that claim 42 is unpatentable as well. Claim 48--Green/Yurek/Ambrisco Appellants argue that the Ambrisco reference does not overcome the alleged deficiencies of Green, nor the alleged deficiencies of the combination of teachings of Green with Yurek. (App. Br. 17). Essentially all of the contentions are merely restatements of claim language found in claim 35, from which claim 48 depends. (Id.). As noted supra, the combination of teachings of Green and Yurek is not deficient with respect to the obviousness of the subject matter of claim 35. Accordingly, we are not Appeal 2009-010642 Application 10/975,851 10 persuaded that the Examiner erred in concluding that claim 48 is unpatentable as well. CONCLUSIONS The Examiner provided an articulated reason to combine the teachings of Green and Yurek that is supported by rational underpinnings. The Examiner did not err in finding that Green discloses a stent attached to a filter. The Examiner erred in finding that Green discloses a guidewire that includes a distal mounting region having a cross-sectional profile less than the guidewire cross-sectional profile, with a filter disposed about at least a portion of the mounting region. DECISION The decision of the Examiner to reject claims 35, 36, 38, 40-42, 47 and 48 is affirmed. The decision of the Examiner to reject claims 44, 45, 51- 53 and 55-59 is reversed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED-IN-PART mls Copy with citationCopy as parenthetical citation