10035013 (B.P.A.I. Jul. 11, 2012)

Ex Parte Kaylor et al

Board of Patent Appeals and InterferencesJul 11, 2012

10035013 (B.P.A.I. Jul. 11, 2012)

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. 10/035,013 12/24/2001 Rosann Kaylor KCX-461 (15790) 1072 7590 07/11/2012 John E. Vick, Jr. Dority & Manning, Attorneys at Law, P.A. P.O. Box 1449 Greenville, SC 29602 EXAMINER ALEXANDER, LYLE ART UNIT PAPER NUMBER 1773 MAIL DATE DELIVERY MODE 07/11/2012 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 ROSANN KAYLOR, DIFEI YANG, and MICHAEL KNOTTS ____________ Appeal 2010-010839 Application 10/035,013 Technology Center 1700 ____________ Before BRADLEY R. GARRIS, CHUNG K. PAK, and PETER F. KRATZ, Administrative Patent Judges. PAK, Administrative Patent Judge DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134 from the Examiner's final rejection of claims 62 through 64, 66, and 69 through 80.1 We have jurisdiction under 35 U.S.C. § 6. 1 See Supplemental Appeal Brief (“App. Br.”) filed November 6, 2008, 2; Examiner’s Answer (“Ans.”) filed February 3, 2009, 3; Reply Brief (“Reply Br.” filed March 3, 2009, 1. Appeal 2010-010839 Application 10/035,013 2 STATEMENT OF THE CASE The subject matter on appeal is directed to a membrane-based test device designed for a lateral flow assay test strip, used in diagnostic medicine, employing “a variety of internal and external calibrators to provide a qualitative or a quantitative result for an analyte of interest in a test solution” (Spec. 1, ll. 3-6 and 3, ll. 7-22). Figures 2, 3, 3a, and 4 representative of the appealed subject matter are depicted below: Appeal 2010-010839 Application 10/035,013 3 In Figures 2 and 3, a reading device 40 having housing exterior 44, an on/off switch 49, and a LCD display 60 laterally receives a membrane strip 41 having a detection zone 42 and a reference zone 43 into a receiving port 45 of a light barrier structure 28. (See Spec. 8.) In Figures 3, 3a, and 4, the light barrier structure 28 is formed by top and bottom plates 50 and 56 defining the receiving port 45, with the bottom plate 56 having a channel 53 for the insertion of the membrane strip 41 and an aperture 54 for allowing the passage of light to the detection zone 42 of the membrane strip 41and the top plate 50 revealing a recess 58 for a pressure plate 51held by spring 52 for resilient engagement with the membrane strip 41 and a light absorbing pad 57 for covering the area (detection zone) of the membrane Appeal 2010-010839 Application 10/035,013 4 strip 41 in contact with the aperture 54 to absorb any light transmitted completely through the membrane strip 41 and prevent reflection of such light back downward towards a sensor. (See Spec. 8-10.) Light generated by a light source such as a LED (light emitting diode) travels through a light pathway 59 along arrow 59a through the aperture 54 and is reflected downward from the membrane strip 41 along arrow 59b. (See Spec. 10.) According to page 10, lines 6 through 10, of the Specification (emphasis added): There is no particular size or shape that is preferred for a light- absorbing member 57 but it is important that the light- absorbing member 57 cover completely the area under which the membrane strip 41 is being impacted by light from its underside. Details of the appealed subject matter are recited in representative claim 62 reproduced below: 62. A system for conducting a lateral flow assay to detect the presence or quantity of an analyte in a sample, the system comprising: (a) a lateral flow membrane strip comprising a detection zone, wherein upon application, the sample is capable of traversing through the membrane strip to the detection zone; and (b) a reading device comprising: (i) a housing within which is contained an electromagnetic radiation source and a sensor capable of detecting the intensity of electromagnetic radiation, wherein the electromagnetic radiation source and sensor are positioned so that electromagnetic radiation emitted from the source is capable of being reflected from the lateral Appeal 2010-010839 Application 10/035,013 5 flow membrane strip to the sensor, the housing having an exterior surface; (ii) a light barrier structure comprising a top plate and a bottom plate, the bottom plate being positioned adjacent to the exterior surface of the housing, wherein a receiving port is defined between the top plate and the bottom plate, the lateral flow membrane strip being capable of insertion into the receiving port, wherein the bottom plate defines an aperture through which electromagnetic radiation from the source is capable of passing before contacting the lateral flow membrane strip, the aperture having a size that approximates the size of the detection zone; and (iii) a light absorbing member positioned within the receiving port to absorb stray light, the light absorbing member comprising an absorption pad that is located adjacent to the membrane strip upon insertion into the receiving port, the absorption pad covering an area under which the membrane strip is impacted by electromagnetic radiation. The Examiner relies upon the following evidence to establish unpatentability of the appealed subject matter (Ans. 6): DeSimone ‘770 EP 0 308 770 A2 Mar. 29, 1989 DeSimone ‘088 US 4,833,088 May 23, 1989 Appeal 2010-010839 Application 10/035,013 6 Appellants seek review of the following grounds of rejection set forth in the Answer2: 1) Claims 62 through 64, 66, 69 through 72, and 74 through 80 under 35 U.S.C. § 102(b), as anticipated by the disclosure of either DeSimone ‘770 or ‘088; and 2) Claim 73 under 35 U.S.C. § 103(a) as unpatentable over the disclosure of either DeSimone ‘770 or ‘088. (See Reply Br. 1-2.) DISCUSSION Appellants contend that DeSimone ‘770 or ‘088 does not teach a light absorbing member comprising an adsorption pad that covers an area under which the membrane strip is impacted by electromagnetic radiation as required by claim 62. (See App. Br. 2.) On the other hand, the Examiner relies on an elastomeric light seal (70) in Figure 5 of DeSimone ‘770 or ‘088 as a structure corresponding to the light absorbing member recited in claim 62 in support of his §§102(b) and 103(a) rejections. (See Ans. 4, 5, and 7.) Thus, the dispositive question is: Has the Examiner demonstrated that the elastomeric light seal (70) in Figure 5 of DeSimone ‘770 or ‘088 corresponds to or identical to “the adsorption pad covering an area under which the membrane strip is impacted by electromagnetic radiation” recited by claim 62? On this record, we answer this question in the negative. 2 The Examiner set forth a new ground of rejection against claim 73 by changing the §102 rejection of claim 73 set forth in the final office action dated April 18, 2008 to the §103 rejection of claim 73 based on the same prior art references, i.e., DeSimone ‘770 or ‘088. (See Ans. 3-6.) Appeal 2010-010839 Application 10/035,013 7 As is apparent from pages 9 and 10 of the Specification and Figures 2, 3, 3a, and 4 of the above-identified application discussed supra, we interpret the phrase “the absorption pad covering an area under which the membrane strip is impacted by electromagnetic radiation” in claim 62 as being limited to a light absorbing material that lines or pads a pressure plate and is particularly sized and arranged to cover the entire area of the section of the membrane strip (i.e., the detection zone ), which is subject to electromagnetic radiation transmitted through the aperture located in the bottom plate. However, as correctly argued by Appellants, the Examiner has not demonstrated that the structure of the elastomeric light seal (70) shown in Figure 5 of DeSimone ‘770 or ‘088 is an absorption pad that is sized and arranged in a particular manner to cover such electromagnetic radiation exposed area of the membrane strip as required by claim 62. (See App. Br. 5-7 and Reply Br. 2.) Thus, on this record, the Examiner has not established a prima facie case of anticipation under 35 U.S.C. § 102(b) or obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (“[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.”) CONCLUSION In view of the foregoing, the decision of the Examiner is reversed. REVERSED tc