Ex Parte Christensen et alDownload PDFPatent Trial and Appeal BoardJan 29, 201512648533 (P.T.A.B. Jan. 29, 2015) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MARK A. CHRISTENSEN, STEVEN M. SMITH, WALTER SHANG, and JAMES D. BEAL ____________ Appeal 2012-005442 Application 12/648,5331 Technology Center 3700 ____________ Before MICHAEL C. ASTORINO, NINA L. MEDLOCK, and BART A. GERSTENBLITH, Administrative Patent Judges. GERSTENBLITH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Mark A. Christensen et al. (“Appellants”) appeal under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1–15. We have jurisdiction under 35 U.S.C. § 6(b). 1 Appellants identify C. R. Bard, Inc. as the real party in interest. Appeal Br. 3. Appeal 2012-005442 Application 12/648,533 2 Claimed Subject Matter Claims 1 and 14 are the independent claims on appeal. Claim 1 is illustrative of the claimed subject matter and is reproduced below. 1. A method for assembling a valved sheath introducer, comprising: providing a valve including a slit, the valve comprising a first anchoring member, a second anchoring member unconnected to the first anchoring member, and a central portion, the slit traversing through the central portion; inserting the valve into a handle, the first and second anchoring members positioned respectively in a first and second receiving sections of the handle and the central portion positioned in a bore of the handle, the central portion having a diameter approximately equal to a diameter of the bore, the first and second anchoring members and central portion extending distally into the handle; and attaching a cap to the handle under pressure, the cap contacting a proximal most surface of the valve and compressing the valve between the cap and the handle. Appeal Br. 27, Claims App. References The Examiner relies upon the following prior art references: Patterson US 5,613,956 Mar. 25, 1997 Dennis US 5,727,770 Mar. 17, 1998 Guo US 2002/0010425 A1 Jan. 24, 2002 Lui US 2003/0050604 A1 Mar. 13, 2003 Rejections Appellants seek review of the following rejections, each of which was made by the Examiner under 35 U.S.C. § 103(a): I. Claims 1–9 and 13 are rejected as unpatentable over Patterson and Guo; Appeal 2012-005442 Application 12/648,533 3 II. Claims 10–12 are rejected as unpatentable over Patterson, Guo, and Lui; III. Claim 14 is rejected as unpatentable over Patterson and Dennis; and IV. Claim 15 is rejected as unpatentable over Patterson, Dennis, and Guo. SUMMARY OF DECISION We REVERSE. OPINION Rejection I The Examiner concludes that the combination of Patterson and Guo would have rendered the subject matter of claims 1–9 and 13 obvious to one of ordinary skill in the art at the time of the invention. Ans. 4–9. The Examiner finds that Patterson discloses the elements of the claims, except that “Patterson teaches a single anchoring member . . . rather than an anchoring member which comprises of a first and second anchoring member being received in a first and second receiving section of the handle.” Id. at 5. The Examiner finds that Guo discloses an anchoring member comprising . . . a first anchoring member and a second anchoring member unconnected to the first anchoring member (figure 5, element 32; page 4, paragraph 58), and the inserting step further comprising positioning the first and second anchoring members in a first and second receiving section of the handle (figure 3, element[s] 32 and 54; page 4, paragraph 58). Id. at 6. Appellants raise several arguments in response to this rejection, including that the Examiner’s proposed combination of Patterson and Guo App App does (refe (Rej elem elem locat gask that Id. a eal 2012-0 lication 12 not disclo rring to A ection IV) ent 54. A ent 54 is n ed on a ga Guo is d et 20 and d [t]he pro are assem two, po valve ga position (20, 40) t para. 58 ( 05442 /648,533 se a secon ppellants’ ). The Exa ns. 16–17. ot “a ‘han sket valve irected to istal valv ximal valv bled by a sitioning p skets (20 ing slots ( as shown emphases d handle r arguments miner resp In their R dle’ receiv .” Reply B a hemosta e gasket 40 e gasket ( ligning an rotrusions , 40) with 34, 54) lo in FIG. 3. omitted). 4 eceiving s in the con onds by p eply Brief ing sectio r. 9. sis valve, w . Guo, pa 20) and th d inserting (32, 52) in one o cated on e Guo’s Fig ection. Ap text of cla ointing to , Appellan n; instead, hich inclu ra. 54. Gu e distal va one or m located o r more, p ach of the ure 3 is re peal Br. 1 im 15 Guo’s Fig ts assert t element 5 des proxi o further lve gasket ore, prefe n each o referably valve ga produced 9 ure 3 and hat Guo’s 4 is mal valve discloses (40) rably f the two, skets below: Appeal 2012-005442 Application 12/648,533 5 Guo’s Figure 3 shows a “distal, perspective-view of the hemostasis valve showing the proximal and distal valve gaskets joined together.” Guo, para. 41. The Examiner’s rejection is based upon the finding that Guo’s distal valve gasket 40 is actually part of the handle, rather than part of hemostasis valve 10. Ans. 5 (“Guo teaches . . . providing a valve (figures 2 and 5, element 20; page 5, paragraph 62) . . . .”); id. at 5–6 (“Guo teaches . . . providing a handle (figures 1 and 2, elements 90 and 40) . . . .”). Finding that valve gasket 40 is part of the handle leads to the Examiner equating protrusions 32 with the recited first and second anchoring members, and equating positioning slots 54 with a first and second receiving sections of the handle. Ans. 6. The Examiner’s finding that Guo’s hemostasis valve does not include distal valve gasket 40 is contrary to Guo’s disclosure that hemostasis valve 10 includes primal valve gasket 20 and distal valve gasket 40. Guo, para. 54. As such, the Examiner’s finding that distal valve gasket 40 is actually part of Guo’s handle is not supported by a preponderance of the evidence. Accordingly, we do not sustain Rejection I. Rejection II Rejection II, directed to claims 10–12, which depend from claim 1, relies upon the same findings discussed above with respect to Rejection I. Ans. 9. Accordingly, for the reasons explained in the context of Rejection I, we do not sustain Rejection II. Appeal 2012-005442 Application 12/648,533 6 Rejection III The Examiner concludes that the combination of Patterson and Dennis would have rendered the subject matter of claim 14 obvious to one of ordinary skill in the art at the time of the invention. Ans. 11–12. In particular, the Examiner finds that Patterson discloses the elements of the claim, except a valve including a central portion extending distally into a handle. Id. at 12. The Examiner finds that Dennis discloses a central portion of a valve extending distally into a handle. Id. The Examiner concludes that it would have been obvious to “form a valved sheath introducer with a central portion, as taught by Patterson, such that the central portion extends distally into a handle, as taught by Dennis, because Dennis teaches that such a central portion acts to seal the housing before a catheter is inserted (column 2, lines 44 – 53).” Id. Appellants raise several arguments in response to this rejection, including that one of ordinary skill would not have sought to combine the teachings of Dennis and Patterson for the reason offered by the Examiner because Patterson’s valve is described as self-sealing and, thus, already maintains a seal when no instrument is inserted through the introducer. Appeal Br. 5. In response, the Examiner asserts that because Patterson’s central portion includes a slit, the bore of the housing is not sealed when a catheter is not inserted. Ans. 14. Appellants assert, in their Reply Brief, that simply because Patterson discloses a slit in its gasket does not mean that the slit cannot be sealed by pressure between its opposite sides. Reply Br. 5. Appellants further assert Appeal 2012-005442 Application 12/648,533 7 that Dennis also discloses that its gasket includes slit 33, which extends through the gasket, yet Dennis’s gasket provides a seal. Id. Patterson discloses a catheter introducer including a housing that “contains and supports one or more self-sealing hemostasis gaskets that close to prevent blood leakage when no instrument is present in the introducer.” Patterson, 1:22–34; id. at 3:46 (“The housing contains a self- sealing hemostasis gasket 8 . . . .” (emphasis omitted)). Patterson specifically explains that the slits are of a relatively small diameter (as compared to a prior art device) to avoid the possibility that the gasket might leak with or without an instrument inserted therethrough. Id. at 4:57–61. We are not persuaded that the Examiner’s reasoning, i.e., that one of ordinary skill in the art would have sought to modify Patterson’s central portion in light of Dennis to enable sealing of the housing before a catheter is inserted, because Patterson already discloses a housing that is self-sealing when no instrument is present in the introducer. Thus, Patterson already provides the benefit sought by the Examiner through the modification. Additionally, the Examiner’s finding that Patterson’s slits result in an unsealed housing when a catheter is not inserted is contradicted by the above-cited disclosures of Patterson, which specifically indicate that the slits do not defeat the self-sealing nature of the gasket. Further, even though we recognize that the structure of Dennis’s device is different, we agree with Appellants that Dennis’s disclosure supports their argument that the presence of a slit alone does not indicate necessarily the lack of a seal. For example, Dennis discloses an elastomeric double valve sealing device for a cannula wherein one of the valves is a “generally conical member divided into two symmetrical halves by a slit.” Appeal 2012-005442 Application 12/648,533 8 Dennis, 2:35–36, 44–50. Yet, Dennis also discloses that the conical valve member “seals the cannula when no instrument is present.” Id. at 2:52–53. Accordingly, we do not sustain Rejection III. Rejection IV Rejection IV, directed to claim 15, which depends from claim 14, relies upon the same findings discussed above with respect to Rejection III. Ans. 12. Accordingly, for the reasons explained in the context of Rejection III, we do not sustain Rejection IV. DECISION We REVERSE the Examiner’s decision rejecting claims 1–15. REVERSED llw Copy with citationCopy as parenthetical citation