11377655 (B.P.A.I. Nov. 16, 2010)

Ex Parte Voegele

Board of Patent Appeals and InterferencesNov 16, 2010

11377655 (B.P.A.I. Nov. 16, 2010)

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. 11/377,655 03/17/2006 Aaron C. Voegele END-5701 5049 21884 7590 11/16/2010 WELSH FLAXMAN & GITLER LLC 2000 DUKE STREET, SUITE 100 ALEXANDRIA, VA 22314 EXAMINER LOW, LINDSAY M ART UNIT PAPER NUMBER 3721 MAIL DATE DELIVERY MODE 11/16/2010 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 AARON C. VOEGELE ____________________ Appeal 2009-008253 Application 11/377,655 Technology Center 3700 ____________________ Before: WILLIAM F. PATE III, MICHAEL W. O’NEILL, and STEFAN STAICOVICI, Administrative Patent Judges. PATE III, Administrative Patent Judge. DECISION ON APPEAL1 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2009-008253 Application 11/377,655 2 STATEMENT OF CASE Appellant appeals under 35 U.S.C. § 134 from the Examiner’s rejections of claims 1-9. Br. 3. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. The claims are directed to a reprocessing indicator ink for medical instruments. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A reprocessed medical instrument, comprising: a body member suitable for reprocessing; ink applied to the body member, wherein the ink is reactive with ethylene oxide gas so as to change the appearance of the ink upon application of the ethylene oxide, the ink is positioned at a discrete position on the medical instrument discernable by those inspecting the medical instrument, but not readily obvious to those reprocessing the medical instrument. REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Vidal Tsuruta Ishikawa Puntambekar Roebuck US 5,405,328 US 5,467,911 US 6,497,714 B1 US 6,800,124 B2 US 6,813,998 B2 Apr. 11, 1995 Nov. 21, 1995 Dec. 24, 2002 Oct. 5, 2004 Nov. 9, 2004 McEwen Rehil US 2003/0167070 A1 US 2004/0034370 A1 Sep. 4, 2003 Feb. 19, 2004 Appeal 2009-008253 Application 11/377,655 3 REJECTIONS Claims 1 and 4 stand rejected under 35 U.S.C. § 102(b) as being anticipated by McEwen. Ans. 3. Claims 1, 4, 5, 8, and 9 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Puntambekar and McEwen. Ans. 3. Claims 2 and 3 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Puntambekar, McEwen, Tsuruta, Vidal, Rehil, and Ishikawa. Ans. 5. Claims 6 and 7 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Puntambekar and McEwen or Puntambekar, McEwen, and Roebuck. Ans. 6. OPINION Regarding the rejection of claim 1 as being anticipated by McEwen, Appellant contends that “[i]n contrast to the claimed invention, McEwen fails to disclose or suggest a reprocessed medical instrument having ink positioned at a discrete position such that it is discernable by those inspecting the medical instrument, but not readily obvious to those reprocessing the medical instrument.” Br. 7. Regarding the rejection of claim 1 as being unpatentable over Puntambekar and McEwen, Appellant contends that Puntambekar does not disclose the feature alleged to be lacking from McEwen. Br. 10. However, the Examiner never asserted that Puntambekar discloses such a feature; in both rejections of claim 1 the Examiner relies upon McEwen for that teaching. Appellant then repeats the argument advanced regarding the rejection under 35 U.S.C. § 102(b) with respect to the rejection of claim 1 under 35 U.S.C. § 103. Br. 10-11. Appellant argues Appeal 2009-008253 Application 11/377,655 4 the rejection of claims 4, 5, 8 and 9 based solely upon dependency from claim 1. Br. 12. Regarding the rejection of claims 2 and 3, Appellant contends that relying upon Tsuruta, Vidal, Rehil, and Ishikawa to conclude it would have been obvious to reprocess a medical instrument, such as a surgical stapler or trocar, as claimed in accordance with the present invention overlooks what has been claimed by Appellant. Br. 13. This is a mischaracterization of the Examiner’s position. Those references are cited by the Examiner only to demonstrate those medical devices are known in the art—a finding which Appellant does not contest. Appellant also does not contest the Examiner’s conclusion that application of McEwen’s sterilization identification technique to devices of the types described in Tsuruta, Vidal, Rehil, and Ishikawa would have been obvious to one having ordinary skill in the art. The rejection of claims 6 and 7 is argued based solely upon dependency from claim 1. Br. 14. In light of these arguments, the sole issue for our consideration is whether the Examiner erred in determining that McEwen discloses a reprocessed medical instrument wherein “ink is positioned at a discrete position on the medical instrument discernable by those inspecting the medical instrument, but not readily obvious to those reprocessing the medical instrument.” Appellant sought to solve the problem of not being able to identify single use medical instruments that have been reprocessed for additional use. Spec. 3:3-5:2. McEwen also recognizes the problem of third party resterilization of, in particular, single-use tourniquet cuffs. P. 2, para. [0009]. Both Appellant and McEwen recognize that ethylene oxide gas sterilization methods are commonly used in the art. Spec. 10:13-15; McEwen P. 2, para. [0009]. To solve this problem, McEwen discloses using a physical Appeal 2009-008253 Application 11/377,655 5 characteristic to allow identification of cuffs 50, 51 that have been exposed to a process such as sterilization. P. 3, para. [0021]. McEwen discloses coating an identifying surface 126 of a collar 21 on the cuffs’ connection arrangement with a commercially available ethylene oxide sterilization indicating ink that undergoes a color change upon exposure to ethylene oxide sterilization. P. 5, para. [0033]; fig. 3. The Examiner reasonably concluded that, due to its interior location, McEwen identifying surface 126 is a “discrete position such that [the ink] is discernable by those inspecting the medical instrument, but not readily obvious to those reprocessing the medical instrument.” Ans. 7. Appellant has not established why McEwen’s identifying surface 126 does not meet this limitation. The provision of additional structure to discern the color change by McEwen is not precluded by the claim. See Br. 7; Ans. 7; McEwen p. 6, para. [0046]. Furthermore, McEwen contemplates “visual identification” of exposure to a process such as sterilization. P. 3, para. [0021]. Since the ink is located on a small interior surface and changes color, the Examiner did not err by determining that McEwen discloses a reprocessed medical instrument wherein “ink is positioned at a discrete position on the medical instrument discernable by those inspecting the medical instrument, but not readily obvious to those reprocessing the medical instrument.” Accordingly, the Examiner’s rejections are sustained. DECISION For the above reasons, the Examiner’s rejections of claims 1-9 are affirmed. Appeal 2009-008253 Application 11/377,655 6 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv) (2010). AFFIRMED nlk WELSH FLAXMAN & GITLER LLC 2000 DUKE STREET, SUITE 100 ALEXANDRIA VA 22314