Ex Parte Jones et al

Patent Trial and Appeal BoardNov 10, 2012

11903463 (P.T.A.B. Nov. 10, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte DONALD K. JONES and VLADIMIR MITELBERG __________ Appeal 2011-012263 Application 11/903,463 Technology Center 3700 __________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and ERICA A. FRANKLIN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a self- expandable aneurysm cover device. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-012263 Application 11/903,463 2 Statement of the Case Background “The present invention relates to a repositionable self-expanding intravascular aneurysm cover device and a hydraulic deployment system for placing the device at a preselected location within a vessel of the human body” (Spec. 1, ll. 3-5). The Claims Claims 1-5 are on appeal. Claim 1 is representative and reads as follows: 1. A self-expandable aneurysm cover device comprising: a generally cylindrical skeletal frame having a longitudinal axis, said frame including a proximal loop portion at the proximal end of said skeletal frame which extends in a plane between opposite sides of said generally cylindrical skeletal frame, which is oblique to the longitudinal axis of the skeletal frame and which has a proximal edge, an elongated headpiece attached to the proximal edge of the proximal loop portion and extending from said proximal edge of the proximal loop portion in a direction generally parallel to the longitudinal axis of the skeletal frame, said skeletal frame being adapted to assume a normal first expanded condition to thereby cause said loop portion to be expanded to form a loop configuration which lies in the plane extending at an oblique angle to the longitudinal axis of said skeletal frame and to cause said skeletal frame to take the form of a generally cylindrical configuration, and upon moving the elongated headpiece in a proximal direction said proximal loop portion is caused to move to a position such that the plane of the loop portion is closer to parallel to the longitudinal axis of the skeletal frame thereby causing the skeletal frame to collapse for easy withdrawal of the aneurysm cover device from a vessel, and wherein the cylindrical skeletal frame includes outer struts and inner struts, the inner struts forming a connecting Appeal 2011-012263 Application 11/903,463 3 mesh extending between the outer struts, said outer struts being larger in cross section than said inner struts, and wherein the spacing between the inner struts in a generally central region of said mesh is much less than the spacing of the inner struts in portions of the skeletal frame near the outer struts. The issue 1 The Examiner rejected claims 1-5 under 35 U.S.C. § 103(a) as obvious over Amplatz, 2 Igaki, 3 and Whalen, II 4 (Ans. 3-9). The Examiner finds that Amplatz teaches a self-expandable aneurysm cover device comprising: a generally cylindrical skeletal frame 10 . . . said skeletal frame 10 being adapted to assume a normal first expanded condition to thereby cause said loop portion 16 to be expanded to form a loop configuration . . . and upon moving the elongated headpiece 24 in a proximal direction . . . causing the skeletal frame 10 to collapse for easy withdrawal of the aneurysm cover device 10 from a vessel (Ans. 3-4). The Examiner finds that the “cylindrical skeletal frame 10 includes outer struts 14, 16 and inner struts 12, the inner struts forming a connecting mesh extending between the outer struts (Fig. 1)” (Ans. 4). The Examiner finds that Igaki teaches “a stent 31 (Fig. 8) for a vessel comprising a mesh wherein the spacing between the inner struts 32 (Fig. 8) 1 We note that the Examiner did not include the Walker reference in either the statement of rejection in the Answer or the Evidence Relied Upon section. We therefore do not further address this reference. 2 Amplatz et al., US 6,468,301 B1, issued Oct. 22, 2002. 3 Igaki, K., US 6,413,272 B1, issued Jul. 2, 2002. 4 Whalen, II et al., US 6,569,190 B2, issued May 27, 2003. Appeal 2011-012263 Application 11/903,463 4 in a generally central region of said mesh is much less than the spacing of the inner struts 32 in portions of the skeletal frame near the outer struts” (Ans. 4). The Examiner finds that Igaki teaches “allowing for the inner struts/mid portion of the stent to have a stronger weave/structure in order maintain its expansion at the target site of the vessel to avoid collapsing of the stent in the weakened area/target site of the vessel” (Ans. 4). Appellants contend that the Examiner “relies on Igaki for the teaching that the the spacing of the inner struts in a general central region of the mesh is much less than the spacing of the inner struts in portions of the skeletal frame near the outer struts” (App. Br. 7). Appellants contend that “Igaki is actually teaching the exact opposite. That is, Igaki is teaching that the [] mid portion 34 of the stent [is] capable of greater expansion to hold the stent in the expanded portion and the end portions 35, 36 have a lower tenacity to match that of the blood vessel that the stent is inserted in” (App. Br. 7). Appellants contend that the “the logic behind the Examiner’s proposed combination is in error, as Igaki actually teaches away from the combination that the Examiner is suggesting” (App. Br. 7). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Amplatz, Whalen II, and Igaki render claim 1 obvious? Findings of Fact 1. Amplatz teaches “a low profile stent suitable for use as a synthetic graft for the non-surgical treatment of an aneurysm” (Amplatz, col. 1, ll. 10-12). Appeal 2011-012263 Application 11/903,463 5 2. Figure 1 of Amplatz is reproduced below: “FIG. 1 is a perspective view of a retrievable self-expanding vascular stent graft” (Amplatz, col. 3, ll. 20-21). 3. Amplatz teaches that the medical device can be stretched into its collapsed configuration and inserted into the lumen of the catheter. The collapsed configuration of the device may be of any shape suitable for easy passage through the lumen of a catheter and proper deployment out the distal end of the catheter. For example, the device may have a relatively elongated collapsed configuration wherein the device is stretched along its longitudinal axis. This collapsed configuration can be achieved simply by stretching the device generally along its axis, e.g. by manually grasping the clamps and pulling them apart, which will tend to collapse the relaxed generally cylindrical portion of the device inwardly toward the device’s axis. Loading such a device into a catheter may be done at the time of implantation and does not require pre-loading of the introducer or catheter. (Amplatz, col. 8, ll. 22-36). Appeal 2011-012263 Application 11/903,463 6 4. Figure 8 of Igaki is reproduced below: “FIG. 8 is a perspective view showing a stent for a vessel of the present invention in which the tubular member is formed by weaving a fine metal wire or a polymer yarn” (Igaki, col. 3, ll. 15-17). 5. Igaki teaches that: The tubular member 33 has a main mid portion 34 having tenacity sufficient to hold the blood vessel in an expanded state on insertion into the blood vessel. On both ends of the main mid portion 34 are integrally formed low tenacity portions 35, 36 lower in tenacity than the main mid portion 34. These low tenacity portions 35, 36 are formed by using a rougher pitch of the meshes than in the main mid portion 34 having a preset mesh density. At this time, the low tenacity portions 35, 36 are preferably knitted so as to be progressively lower in mesh density from the main mid portion 34 towards the ends of the tubular member 33. (Igaki, col. 5, ll. 45-55). 6. Igaki teaches that: It is noted that the main mid portion 34 is knitted so as to have meshes of such density sufficient to realize the Young’s modulus sufficiently larger than that of the blood vessel to hold the blood vessel in an expanded state on insertion of the stent 31 in the blood vessel, while the low Appeal 2011-012263 Application 11/903,463 7 tenacity portions 35, 36 are knitted so as to have meshes of such density approximately equal to or slightly larger than that of the blood vessel. (Igaki, col. 5, ll. 56-63). 7. Whalen II, teaches a stent which “has two rigid end segments (303, 305) which can be expanded against the sides of the parent artery in a known manner, e.g., balloon or self expanding . . . The mechanical stent also has a flexible region (307) or open mesh or other open structure located in between the two rigid end segments (303, 305)” (Whalen II, col. 15, ll. 35- 40). 8. Whalen II teaches that the “flexible region (307) of the mechanical stent allows for increased ease of manipulation or trackability of the stent through the vasculature as the stent is directed to the site of the aneurysm” (Whalen II, col. 15, ll. 41-43). 9. Figure 3 of Whalen II is reproduced below: “FIG. 3 is a schematic side view of a stent for use in a method of treating an aneurysm” (Whalen II, col. 4, ll. 48-49). Appeal 2011-012263 Application 11/903,463 8 Principles of Law “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). “[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 conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis The Examiner acknowledges that the reasoning relied upon in the Final Rejection “was a misinterpretation of Igaki’s reasoning to create a stent structure having less spacing between the inner struts than the outer struts” (Ans. 9). To remedy this misinterpretation, the Examiner alters the motivation to modify Amplatz “in order to allow for the inner struts/mid portion of the stent to have a stronger weave/ structure in order maintain its expansion at the target site of the vessel to avoid collapsing of the stent in the weakened area/target site of the vessel” (Ans. 9). We are not persuaded. While Igaki may teach a midportion 34 which holds the blood vessel in the expanded state (FF 4-6), neither Amplatz nor Whalen II recognize a need or reason for a strengthened stent mid portion. Indeed, Whalen II expressly teaches that the midportion may be flexible (FF Appeal 2011-012263 Application 11/903,463 9 7-8) and uses a more open and less rigid mesh weave in the midportion of the stent, the precise opposite of Igaki. We do not find it reasonable to rely on Whalen II for the use of rigid outer struts to anchor the stent and flexible inner struts in combination with Igaki for the use of a more rigid inner struts to anchor the stent, in order to address a claim which requires “the spacing between the inner struts in a generally central region of said mesh is much less than the spacing of the inner struts in portions of the skeletal frame near the outer struts” (Claim 1). Selection of either reference alone results in a stent inconsistent with the requirements of claim 1. However, even when combined, there is no articulated and rational reason to select the outer strut structure from Whalen II and the inner strut structure from Igaki other than hindsight reconstruction of claim 1. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Amplatz, Whalen II, and Igaki render claim 1 obvious. SUMMARY In summary, we reverse the rejection of claims 1-5 under 35 U.S.C. § 103(a) as obvious over Amplatz, Igaki, and Whalen, II. REVERSED alw