Ex Parte Barker et alDownload PDFPatent Trial and Appeal BoardMay 6, 201511952883 (P.T.A.B. May. 6, 2015) 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. 11/952,883 12/07/2007 Peter Barker 151419-031A 1111 124136 7590 05/06/2015 Inskeep Intellectual Property Group, Inc. 2281 W. 190th Street Suite 200 Torrance, CA 90504 EXAMINER EREZO, DARWIN P ART UNIT PAPER NUMBER 3734 MAIL DATE DELIVERY MODE 05/06/2015 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte PETER BARKER, JAY LENKER, and EDWARD NANCE __________ Appeal 2012-008417 Application 11/952,883 Technology Center 3700 __________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and ELIZABETH A. LaVIER, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a medical access system adapted for providing minimally invasive access to a biological body. The Examiner rejected the claims as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the Real Party in Interest as Onset Medical Corporation (see App. Br. 3). Appeal 2012-008417 Application 11/952,883 2 Statement of the Case Background “A wide variety of diagnostic or therapeutic procedures involves the introduction of a device through a natural or artificially created access pathway” (Spec. 1). The Claims Claims 1–25 are on appeal. Independent claim 1 is representative and reads as follows: 1. A medical access system adapted for providing minimally invasive access to a biological body, comprising: an access sheath comprising an axially elongate tubular body that defines a lumen, at least a distal portion of the elongate tubular body being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile to form an expanded distal portion of the sheath, the access sheath having a distal edge; a dilator slidably disposed within the lumen of the axially elongate tubular body, wherein the dilator has a first, non-expanded configuration and has a second, expanded configuration, which is capable of expanding the first, folded smaller, cross-sectional profile of the access sheath into the second, greater cross-sectional profile of the access sheath; and a tapered distal fairing that shields the distal edge of the access sheath from tissue as the sheath is being advanced distally into the body, wherein the distal fairing is affixed to the dilator, and a proximal end of the tapered distal fairing has an inside diameter that expands to approximately the same diameter as the outside diameter of the dilator when the dilator is in its expanded configuration and has an outside diameter that contracts to a diameter smaller than an inside diameter of the expanded distal portion of the access sheath when the dilator collapses to a collapsed configuration. Appeal 2012-008417 Application 11/952,883 3 The Issues A. The Examiner rejected claims 1–3, 11–16, and 21–25 under 35 U.S.C. § 102(e) as anticipated by Lenker2 (Ans. 4–7). B. The Examiner rejected claims 4, 5, and 17 under 35 U.S.C. § 103(a) as obvious over Lenker and Balceta3 (Ans. 8–9). C. The Examiner rejected claims 6–10 under 35 U.S.C. § 103(a) as obvious over Lenker (Ans. 9–11). D. The Examiner rejected claims 18–20 under 35 U.S.C. § 103(a) as obvious over Lenker and Trask4 (Ans. 11). Because the same issue is dispositive for all four rejections, we will consider them together. The issue with respect to these rejections is: Does the evidence of record support the Examiner’s conclusion that Lenker teaches a distal fairing that: has an inside diameter that expands to approximately the same diameter as the outside diameter of the dilator when the dilator is in its expanded configuration and has an outside diameter that contracts to a diameter smaller than an inside diameter of the expanded distal portion of the access sheath when the dilator collapses to a collapsed configuration as required by claim 1? 2 Lenker et al., US 2006/0135981 A1, published June 22, 2006. 3 Balceta et al., US 6,093,173, issued July 25, 2000. 4 Trask et al., US 2003/0050658 A1, published Mar. 13, 2003. Appeal 2012-008417 Application 11/952,883 4 Findings of Fact 1. Lenker teaches “a sheath having a non-expandable proximal end and a radially expandable distal end that can be expanded from an outer diameter of about 10 French or smaller to an outer diameter of greater than about 12 French” (Lenker ¶ 12). 2. Figures 13A and 13B of Lenker are reproduced below: “FIG. 13A illustrates a radially expandable transluminal sheath comprising an expandable distal outer wall, one or more wall reinforcements, and a hollow axially advanceable dilator” (Lenker ¶ 55). “FIG. 13B illustrates the radially expandable transluminal sheath of FIG. 13A wherein the dilator has been translated or advanced forward to dilate the distal end of the sheath” (Lenker ¶ 56). Appeal 2012-008417 Application 11/952,883 5 3. Lenker teaches that at “least a portion of the distal end of the elongate tubular member is expandable from a first, smaller cross-sectional profile to a second, greater cross-sectional profile by plastic yield” (Lenker ¶ 19). 4. Lenker teaches that in “another embodiment, the plastically deformable tubular member is replaced by a folded or creased sheath that is expanded by a dilatation balloon or axially translating dilator” (Lenker ¶ 19). 5. Lenker teaches that an “inner member, in an embodiment generates the force to expand the sheath. The inner member, which can be a dilatation balloon, is removable to permit subsequent instrument passage through the sheath” (Lenker ¶ 19). 6. Lenker teaches that the “sheath 1300 also comprises a translation dilator 1320 further comprising a dilator shaft 1310, a dilator hub 1312, and a dilator tip 1322” (Lenker ¶ 102). 7. Lenker teaches that the “tip 1322 is formed by radio frequency or induction heating or it is a separate piece of material welded or bonded to the distal end of the dilator shaft 1310” (Lenker ¶ 105). 8. Lenker teaches that the “tip 1322 is tapered on its exterior to facilitate passage through the diametrically compressed distal layer 1308. The tip 1322 is either hard or, in a preferred embodiment, soft and resilient” (Lenker ¶ 105). Principles of Law “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior Appeal 2012-008417 Application 11/952,883 6 art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). Analysis The Examiner finds that Lenker teaches: (Since the dilator can collapse to fit within the sheath and the tapered fairing is on the exterior of the dilator, the inside diameter of the fairing will be around the same length of the outside of the dilator; and the outside diameter of the fairing will have a smaller diameter than the inside diameter of the sheath in order for the dilator and fairing to fit inside the sheath when collapsed). (Ans. 5). Appellants contend that “Lenker simply discloses a tapered fairing of fixed inside and outside diameter. Lenker does not disclose that the tapered distal fairing has an inside diameter that expands, nor does it disclose that the tapered distal fairing has an outside diameter that contracts” (App. Br. 7). Appellants contend that “even assuming, arguendo, if a tapered distal fairing were attached to the distal end of a balloon dilator in Lenker, the combination does not disclose that the tapered distal fairing would be attached to an expandable portion of the balloon dilator” (Reply Br. 4–5). We find that Appellants have the better position. Lenker does not require that the entire distal end is expandable, only a “portion of the distal end” (FF 3). The Examiner has not established that the portion of the distal end which is expandable (and contractable) necessarily or inherently includes tapered tip 1322 located at the distal end of the dilator shaft 1310 (FF 2, 7). “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of Appeal 2012-008417 Application 11/952,883 7 circumstances is not sufficient.” MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (citation omitted). Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Lenker teaches a distal fairing that: has an inside diameter that expands to approximately the same diameter as the outside diameter of the dilator when the dilator is in its expanded configuration and has an outside diameter that contracts to a diameter smaller than an inside diameter of the expanded distal portion of the access sheath when the dilator collapses to a collapsed configuration as required by claim 1. SUMMARY In summary, we reverse the rejection of claims 1–3, 11–16 and 21–25 under 35 U.S.C. § 102(e) as anticipated by Lenker. We reverse the rejection of claims 4, 5, and 17 under 35 U.S.C. § 103(a) as obvious over Lenker and Balceta. We reverse the rejection of claims 6–10 under 35 U.S.C. § 103(a) as obvious over Lenker. We reverse the rejection of claims 18–20 under 35 U.S.C. § 103(a) as obvious over Lenker and Trask. REVERSED ELD Copy with citationCopy as parenthetical citation