Ex Parte Song

Patent Trial and Appeal BoardMar 31, 2015

11956420 (P.T.A.B. Mar. 31, 2015)

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. 11/956,420 12/14/2007 Xuedong Song KCX-1418 (64359252US01) 7439 22827 7590 03/31/2015 DORITY & MANNING, P.A. POST OFFICE BOX 1449 GREENVILLE, SC 29602-1449 EXAMINER SASAKI, SHOGO ART UNIT PAPER NUMBER 1773 MAIL DATE DELIVERY MODE 03/31/2015 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 XUEDONG SONG ______________ Appeal 2013-003971 Application 11/956,420 Technology Center 1700 _______________ Before CHARLES F. WARREN, N. WHITNEY WILSON, and WESLEY B. DERRICK, Administrative Patent Judges. WARREN, Administrative Patent Judge. DECISION ON APPEAL Applicant appeals to the Board under 35 U.S.C. § 134(a) from the decision of the Primary Examiner finally rejecting claims 1–5 under 35 U.S.C. § 103(a) over Masuda (US 4,472,498). Br. 4; Ans. 4. We have jurisdiction. 35 U.S.C. § 6(b). We reverse the decision of the Primary Examiner. Claim 1 illustrates Appellant’s invention of a multi-layered device for detecting the presence or absence of an analyte within a test sample, and is representative of the claims on appeal: 1. A multi-layered device for detecting the presence or absence of an analyte within a test sample, the device comprising: a sensing layer, the sensing layer configured to support a reaction so as to exhibit a signal indicative of the presence or absence of the analyte in the test sample wherein the sensing layer is covered by a material defining an opening, the opening permitting the test sample to contact the sensing layer; and Appeal 2013-003971 Application 11/956,420 2 a control layer, the control layer being in fluid communication with and vertically adjacent to the sensing layer, the control layer including a reagent capable of inhibiting the reaction at the sensing layer by diffusive movement of the reagent from the control layer to the sensing layer. App. Br. 9 (9. Claims App’x). OPINION The threshold issue in this appeal is whether the Examiner erred in finding that Masuda would have disclosed to one of ordinary skill in the art a multi-layered device having a layer of material defining an opening disposed on a detection layer. In this respect, the Examiner finds that Masuda would have taught one of ordinary skill in the art a multi-layered analysis film having a reaction layer provided over a detection layer that has a supporting frame at its edges, thus disclosing a cover layer defining an opening over the detection layer, citing the following portion: It is necessary that the detection element have or exhibit planarity upon measurement in order to maintain accuracy of measurement; accordingly, it is generally necessary for the detection element to comprise supporting means, such as a frame, for mechanically compressing the element at the edge portions. On the other hand, it is sufficient that the reaction layer have an area sufficient to cover openings for spotting or dropping liquid therethrough. If the reaction layer is extended to the supporting means provided at the edge portions of the detection layer, i.e., if the reaction layer has the same area as that of the detection layer, such would result in waste of expensive reagents. Masuda col.16 l.64–col.7 l.8 (emphasis ours); see also Masuda col.16 ll.3–63. Ans. 4–5, 6–8. Appellant contends that Masuda would not have described “that the frame cited by the Examiner is used to cover” the detection layer but instead to mechanically compress the detection layer. Br. 5. On this record, we agree with Appellant that the Examiner erred in Appeal 2013-003971 Application 11/956,420 3 this respect. We find that the Examiner has not adduced evidence or technical reasoning which establishes the structure that Masuda’s disclosed “frame, for mechanically compressing the [the detection layer] at the edge portions” would have described to one of ordinary skill in the art that “the sensing layer is covered by a material defining an opening”, which is necessary in the first instance to establish a prima facie case of obviousness on the basis advanced by the Examiner. Indeed, the Examiner has not established whether the “frame” encompasses and thus compresses the horizontal top “edges” of the detection layer in the vertical direction as opposed to encompassing the vertical side “edges” of the detection layer to restrict the detection layer from expanding in the horizontal direction. Cf. Masuda col.16 ll.54–58 (“the reaction layer is physically restricted from expanding in the horizontal direction”). Accordingly, in the absence of a prima facie case of obviousness, we reverse the ground of rejection of claims 1–5 under 35 U.S.C. § 103(a) over Masuda. The Primary Examiner’s decision is reversed. REVERSED kmm