10544431 (P.T.A.B. Feb. 19, 2013)

Ex Parte Nakayama et al

Patent Trial and Appeal BoardFeb 19, 2013

10544431 (P.T.A.B. Feb. 19, 2013)

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. 10/544,431 05/25/2006 Toru Nakayama 782_233 7161 25191 7590 02/20/2013 BURR & BROWN PO BOX 7068 SYRACUSE, NY 13261-7068 EXAMINER FOREMAN, JONATHAN M ART UNIT PAPER NUMBER 3736 MAIL DATE DELIVERY MODE 02/20/2013 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 TORU NAKAYAMA, MARIKO NAKAYAMA, MASAFUMI NAKAYAMA, and TAKAYUKI NAKAYAMA ____________ Appeal 2012-010632 Application 10/544,431 Technology Center 3700 ____________ Before STEFAN STAICOVICI, MICHAEL C. ASTORINO, and LYNNE H. BROWNE, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL Appeal 2012-010632 Application 10/544,431 2 STATEMENT OF THE CASE Toru Nakayama et al. (Appellants) appeal under 35 U.S.C. § 134 from the Examiner’s decision finally rejecting claims 1 and 3 under 35 U.S.C. § 103(a) as being unpatentable over Kudo (Illustrated Phlebotomy Procedure, pp. 68-69 (1980)) and Lambert (US 5,035,704, iss. Jul. 30, 1991). Claim 2 has been canceled. We have jurisdiction over this appeal under 35 U.S.C. § 6. THE INVENTION Appellants’ invention relates to a method for painless blood collection by puncturing the dorsal surface of a finger at a depth of no more than 0.5 mm. Spec. 2, ll. 2-3 and 11-12 and Spec. 3, ll. 1-3.1 Claim 1, the sole independent claim, is representative of the claimed invention and reads as follows: 1. A method for collecting blood with little pain, comprising: forming a puncture at a puncture site of a finger of a human being by one of a needle and another puncturing device, wherein (a) a depth of the puncture is no more than 0.4 mm, and (b) the puncture site is located on the dorsal surface of a finger and is defined by an area from a finger joint to a proximal nail wall and the area extending from the proximal nail wall to a lateral nail wall, wherein the finger joint is one of an IP joint of a thumb and a DIP joint of a finger other than the thumb; and enhancing bleeding by applying persistent positive pressure using a method selected from the group 1 References to the Specification refer to the marked up copy filed February 15, 2007. Appeal 2012-010632 Application 10/544,431 3 consisting of inflecting the finger joint of the punctured finger, asserting compression or avascularization at a proximal area from the puncture site on the finger, and compressing a tip of the punctured finger. SUMMARY OF DECISION We REVERSE. ANALYSIS2 The Examiner found that Kudo discloses all the limitations of claims 1 and 3, but “fails to disclose the depth of [the] skin puncture being no more than 0.3 mm.” Ans. 5. The Examiner further found that Lambert discloses a blood collection method with little pain including puncturing the skin of a patient at a depth of no more than 0.3 mm. Id. (citing to Lambert, col. 17, ll. 3-7). The Examiner concluded that: It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the depth of puncture [in Kudo] to be no more than 0.3 mm as taught by Lambert et al. in order to reduce physical and emotional pain associated with blood sampling. Id. (citing to Lambert, col. 17, ll. 7-12). Appellants argue that the Examiner only arrives at the conclusion of obviousness due to hindsight. Reply Br. 10. According to Appellants: 2 This is Appellants’ second appeal before the Patent Trial and Appeal Board. In the first appeal (2009-013513, Decision mailed November 5, 2010) (hereafter “Decision,”), the rejection under 35 U.S.C. § 103(a) of claims 1 and 3 as unpatentable over Kiesewetter (US 4,547,735, issued Oct. 15, 1985), Lambert (US 5,035,704, iss. Jul. 30, 1991), and Cunningham (US 2002/0169393 A1, publ. Nov. 14, 2002) was reversed. Decision, 6. Appeal 2012-010632 Application 10/544,431 4 One skilled in the art would not have had any logical reason to instead conclude that a sufficient amount of blood could possibly be collected from a puncture having a depth of less than 0.4 mm on any part of the finger, and would not have had any reasonable expectation of success in so doing, much less expect that any predictable results could have been achieved at such a shallow puncture depth in the specifically claimed location of the finger. Id. In response, the Examiner takes the position that [a]s technology advances less and less blood or body fluid is needed in order to carry out an analysis for an analyte . . . one having skill in the art would look to reduce pain to the user by reducing the depth of the puncture with a possible reduction in the amount of fluid collected as a possible, but not negative, side effect. Ans. 6-7. Although we appreciate the Examiner’s position that making a shallow puncture in a patient’s skin, as taught by Lambert, in the process of Kudo would reduce both pain and the amount of collected blood, we note that in contrast to Lambert’s blood collection method, Kudo discloses a treatment method. Kudo, p. 68 and Lambert, col. 1, ll. 15-18. Specifically, Kudo discloses a method for treating peripheral circulation disorder caused by fatigue and cold where “the blood flow rate decreases and the retention blood volume increases, and congestion is caused at the end of the finger (toe).” Kudo, p. 68. According to Kudo, a puncture with a depth of 1.5 mm is made at “about 2 mm below the proximal corner of the nail of [a patient’s] fingers (toes)” and pressure is repeatedly applied at the tip of the patient’s finger “to gather blood at the puncture point of the patient.” Id., pp. 68 and Appeal 2012-010632 Application 10/544,431 5 69. We thus agree with Appellants that Kudo’s treatment method requires puncturing a patient’s skin in a specific point, i.e., 2 mm below the proximal corner of the nail of a patient’s fingers (toes) and 1.5 mm deep (see Reply Br. 4), such that blood is released to increase blood flow and decrease retention blood volume. Thus, while the Examiner correctly points out that a puncture depth of less than 0.3 mm, as taught by Lambert, can be made in Kudo’s treatment method, this in no way demonstrates that Kudo’s treatment method would be able to treat peripheral circulation disorder caused by fatigue and cold if a different puncture point is chosen. As noted by Appellants, Kudo’s specific puncture point has been “traditionally used for at least several centuries.” Reply Br. 5; see also App. Br., Appendix B8, WHO Standard Acupuncture Point Locations in the Western Pacific Region, pp. 4 and 17, fig. 10, World Health Organization (2008). In other words, just because a shallow puncture can be made in Kudo’s treatment method to reduce physical and emotional pain associated with blood sampling, as the Examiner proposes, this does not mean that a puncture made at 2 mm below the proximal corner of the nail of a patient’s fingers (toes) and a depth of less than 0.3 mm can treat Kudo’s peripheral circulation disorder caused by fatigue and cold. Therefore, for the foregoing reasons, the Examiner’s conclusion of obviousness is based on speculation and conjecture based on an unfounded assumption that one of ordinary skill in the art would have reasonably expected that Kudo’s treatment method would be applicable when reducing the puncture depth from 1.5 mm to less than 0.3 mm as taught by Lambert. The examiner has the initial duty of supplying the requisite factual basis and may not, because of doubts that the invention is patentable, resort to Appeal 2012-010632 Application 10/544,431 6 speculation, unfounded assumptions or hindsight reconstruction to supply deficiencies in the factual basis. In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). Since speculation and conjecture cannot form the basis for concluding obviousness, we do not sustain the rejection of independent claim 1 and its dependent claim 3 under 35 U.S.C. § 103(a) as unpatentable over Kudo and Lambert. See In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988). SUMMARY The Examiner’s decision to reject claims 1 and 3 is reversed. REVERSED mls