Ex Parte Szabo et alDownload PDFPatent Trial and Appeal BoardJan 29, 201611317479 (P.T.A.B. Jan. 29, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111317,479 12/23/2005 138035 7590 01/29/2016 Cardinal Health, Inc./Dergosits & Noah Three Embarcadero Center Suite 410 San Francisco, CA 94111 FIRST NAMED INVENTOR David Szabo 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. ETH5257USNP 6068 EXAMINER DANG, PHONG SON H ART UNIT PAPER NUMBER 3731 MAILDATE DELIVERY MODE 01129/2016 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 DAVID SZABO, JONATHAN GABEL, RODDI SIMPSON, BENJAMIN WICKS, and DAVID GALE Appeal2013-008728 Application 11/317,479 Technology Center 3700 Before JOHN C. KERINS, STEFAN STAICOVICI, and LEE L. STEPINA, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE David Szabo et al. (Appellants) appeal under 35 U.S.C. § 134(a) from the Examiner's decision rejecting claims 1-5, 7, 8, 14, 25, and 39--41. 1 We have jurisdiction over this appeal under 35 U.S.C. § 6(b ). We REVERSE. CLAIMED SUBJECT MATTER The claimed invention relates to vessel wound closure techniques. Spec. ,-r 1. 1 Claims 6, 9-13, 15-24, and 26 have been cancelled and claims 27-38 have been withdrawn from consideration. Ans. 2 (mailed March 29, 2013). Appeal2013-008728 Application 11/317,479 Claim 1, the sole independent claim is representative and is reproduced below: 1. A vessel wound closure system used prior to performance of an interventional procedure in a target vessel, compnsmg: a self-sealing septum material adapted to be disposed onto adventitia of the target vessel; and a stepped needle comprising a smaller diametered distal portion and a larger diametered proximal portion, the smaller diametered portion comprising a pointed tip configured to pierce through the adventitia of the target vessel to allow the larger diametered portion to externally abut the adventitia of the target vessel, the larger diametered portion comprising at least one opening formed in a side wall thereof, through which the self-sealing septum material is disposed onto the adventitia of the target vessel. Appeal Br. 1 7. REFERENCES RELIED ON BY THE EXAMINER Strother Katsaros Dubrul Hnojewyj Edwards Khosravi us 4,364,392 us 5,413,571 US 6,238,412 Bl US 6,475,182 Bl US 6,733,515 Bl US 7,335,220 B2 REJECTIONS ON APPEAL 2 Dec. 21, 1982 May 9, 1995 May 29, 2001 Nov. 5, 2002 May 11, 2004 Feb.26,2008 Claims 1-5, 7, 8, 14, 25, and 39--41 are rejected under 35 U.S.C. 2 Edwards is applied in the rejection of independent claim 1. Final Act. 3. Each of claims 4, 5, 25, 40, and 41 depends indirectly from claim 1. Br. 17- 19, 22. The Examiner appears to have inadvertently omitted Edwards as part of the discussion of these dependent claims. See Final Act. 4--8. However, we include Edwards in our analysis of these claims based on the rejection of base claim 1. 2 Appeal2013-008728 Application 11/317,479 § 112, first paragraph, as failing to comply with the written description requirement. Claims 1-3, 7, 8, 14, and 39 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Hnojewyj and Edwards. Claim 4 is rejected under 35 U.S.C. § 103(a) as unpatentable over Hnojewyj, Edwards, and Strother. Claim 5 is rejected under 35 U.S.C. § 103(a) as unpatentable over Hnojewyj, Edwards, Strother, and Katsaros. Claim 25 is rejected under 35 U.S.C. § 103(a) as unpatentable over Hnojewyj, Edwards, and Khosravi. Claims 40 and 41 are rejected under 35 U.S.C. § 103(a) as unpatentable over Hnojewyj, Edwards, and Dubrul. ANALYSIS The rejection of claims 1-5, 7, 8, 14, 25, and 39-41 as failing to comply with the written description requirement Claim 1 recites, in part, "the smaller diametered portion comprising a pointed tip configured to pierce through the adventitia of the target vessel." Br. 1 7. The Examiner finds that the phrase "the smaller diametered portion comprising a pointed tip" is not "recited in the written specification." Final Act. 2. The Examiner's position is that it is unclear "from the drawing if the tip is pointed or not." Ans. 2-3 (citing Spec. Fig. 2a ). The Examiner concludes that because "the written specification of the current application fails to teach that the tip is 'pointed' or 'not blunt,' ... the new matter rejection is appropriate and proper." Id. at 3. 3 Appeal2013-008728 Application 11/317,479 Appellants assert that "Fig. 2a of the present application, [] clearly illustrates a pointed tip (see element 1121 )." Br. 5 (emphasis omitted). Appellants also assert that "the [S]pecification of the application describes, 'the first needle 120 could instead be a stepped needle,"' and that"' [b ]lunt dissection may not be necessary where the stepped needle 1120 locates the target vessel (V) and delivers the septum material 100 to the adventitia (a) of the target vessel (V)."' Id. (citing Spec. p. 8, 1. 3 and p. 8, 11. 8-10). Appellants, therefore, "submit that Claim 1 clearly meets the requirements of 35 U.S.C. 112." Id. We reproduce Appellants' Figure 2a below. FIG~ 2a 1120 ---~=---1 rf=-, _, '--~ , ,_,,,,,,,, I t123 a v 100 Figure 2a illustrates a stepped needle penetrating into the target vessel prior to performance of an interventional procedure. Spec. i-f 27. We agree with Appellants that the Specification supports the disputed claim limitation, because Figure 2a shows smaller diameter portion 1121 of needle 1120 as having a pointed tip that is configured to penetrate into, i.e., pierce the target vessel. Spec. i-f 27 and Fig. 2a. Thus, we do not sustain the 4 Appeal2013-008728 Application 11/317,479 rejection of claims 1-5, 7, 8, 14, 25, and 39-41 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. The rejection of claims 1-3, 7, 8, 14, and 39 as unpatentable over Hnojewyj and Edwards The Examiner finds that Hnojewyj teaches most of the limitations of claim 1 including smaller diametered portion 12, but that Hnojewyj fails to teach that "the smaller diametered portion compris[es] a pointed tip." Final Act. 4 (citing Hnojewyj, col. 3, 11. 21-24 and Fig. 16). The Examiner relies on Edwards as teaching a "smaller diametered portion (distal tip portion of 196, Fig. 29) comprising a pointed tip." Id. (citing Edwards, Fig. 29). The Examiner concludes that it would have been obvious to one of ordinary skill in the art at the time of the invention "to employ a pointed tip of a puncture sealing device of Edwards for the tip of a puncture sealing device of Hnojewyj in order to enhance entering through vesseis wan tissues." Id. In the Answer, the Examiner takes the position that "a smaller diameter portion configured to pierce through the adventitia of the target vessel" is a functional limitation that is "deemed not to impose any structural limitations on the claims distinguishable over[] Hnojewyj" and thus, the modification of Hnojewyj is reasonable because "the tip of catheter 12 [of Hnojewyj] is clearly capable of pushing through tissues if one would desire to do so." Ans. 3-5. The Examiner points out that "Edwards is merely to show obviousness that 'pointed tip' for piercing through tissues are well known in the art and if one would desire to utilize the 'pointed tip' for piercing through tissue, it is well known and obvious to do such." Id. 5 Appeal2013-008728 Application 11/317,479 Appellants argue that Hnojewyj does not disclose a smaller diametered portion configured to pierce through the adventitia of the target vessel, because "Hnojewyj specifically teaches that the elongated member is introduced into the vessel through a preformed puncture site." Br. 9 (citing Hnojewyj, col. 3, 11. 41--43 and 46-49). Appellants assert that "Hnojewyj does not teach or suggest any suitable structure disposed at the distal end of the elongated member, which enables a piercing operation of the elongated member." Id. Appellants also argue that "Edwards fails to overcome the underlying deficiencies of Hnojewyj, because Edwards does not teach or suggest a smaller diametered portion configured to pierce through the adventitia of the target vessel." Id. at 11. Appellants assert that Edwards, similar to Hnojewyj, teaches that "the distal end of the dilator (196) is configured to enlarge a preformed puncture, rather than to pierce through a vessel wall." Id. (citing Edwards, col. 7, 11. 55-57 and col. 13, 11. 1-3). Aithough we appreciate that the disputed iimitations are functionai, we do not agree with the Examiner's determination that Hnojewyj 's smaller diameter portion 12 is capable of piercing through the tissue, because the Examiner does not point to any portion of the prior art, or provide any technical reasoning why Hnojewyj's smaller diameter portion 12 is capable of piercing through the tissue. Moreover, even though the phrase "configured to" can mean "capable of," as the Examiner proposes, in this case, the written description makes clear that "configured to" as used in claim 1 has a narrower meaning, namely, that the claimed smaller diametered portion is designed or constructed to penetrate into or pierce through the target vessel. See In re Giannelli, 739 F. 3d 1375, 1379 (Fed. Cir. 2014). We find that neither Hnojewyj's smaller diameter portion 12 nor 6 Appeal2013-008728 Application 11/317,479 the distal tip portion of Edwards' dilator 196 are "designed or constructed" to "pierce through the adventitia" because each of these portions is introduced into the vessel through a preexisting puncture site. The Examiner does not persuasively explain why it would have been obvious to modify a device having a tip designed to enter through a puncture site to one that forms the puncture. For these reasons, we do not sustain the Examiner's rejection of claims 1-3, 7, 8, 14, and 39 as unpatentable over Hnojewyj and Edwards. The rejection of claim 4 as unpatentable over Hnojewyj, Edwards, and Strother The Examiner does not rely on Strother in any manner that would overcome the deficiency of the rejection of claim 1 based on Hnojewyj and Edwards. Accordingly, for the same reasons discussed above, we do not sustain the Examiner's rejection of ciaim 4. The rejection of claim 5 as unpatentable over Hnojewyj, Edwards, Strother, and Katsaros The Examiner does not rely on Strother or Katsaros in any manner that would overcome the deficiency of the rejection of claim 1 based on Hnojewyj and Edwards. Accordingly, for the same reasons discussed above, we do not sustain the Examiner's rejection of claim 5. 7 Appeal2013-008728 Application 11/317,479 The rejection of claim 25 as unpatentable over Hnojewyj, Edwards, and Khosravi The Examiner does not rely on Khosravi in any manner that would overcome the deficiency of the rejection of claim 1 based on Hnojewyj and Edwards. Accordingly, for the same reasons discussed above, we do not sustain the Examiner's rejection of claim 25. The rejection of claims 40 and 41 as unpatentable over Hnojewyj, Edwards, and Dubrul The Examiner does not rely on Dubrul in any manner that would overcome the deficiency of the rejection of claim 1 based on Hnojewyj and Edwards. Accordingly, for the same reasons discussed above, we do not sustain the Examiner's rejection of claims 40 and 41. DECISION The decision of the Examiner to reject claims 1-5, 7, 8, 14, 25, and 39-41under35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement is reversed. The decision of the Examiner to reject claims 1-3, 7, 8, 14, and 39 under 35 U.S.C. § 103(a) as being unpatentable over Hnojewyj and Edwards is reversed. The decision of the Examiner to reject claim 4 under 35 U.S.C. § 103(a) as being unpatentable over Hnojewyj, Edwards, and Strother is reversed. The decision of the Examiner to reject claim 5 under 35 U.S.C. 8 Appeal2013-008728 Application 11/317,479 § 103(a) as being unpatentable over Hnojewyj, Edwards, Strother, and Katsaros is reversed. The decision of the Examiner to reject claim 25 under 35 U.S.C. § 103(a) as being unpatentable over Hnojewyj, Edwards, and Khosravi is reversed. The decision of the Examiner to reject claims 40 and 41 under 35 U.S.C. § 103(a) as being unpatentable over Hnojewyj, Edwards, and Dubrul is reversed. REVERSED msc 9 Copy with citationCopy as parenthetical citation