Ex Parte Tao et alDownload PDFPatent Trial and Appeal BoardAug 21, 201812739388 (P.T.A.B. Aug. 21, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/739,388 08/16/2010 28213 7590 08/23/2018 DLA PIPER LLP (US) 4365 EXECUTIVE DRIVE SUITE 1100 SAN DIEGO, CA 92121-2133 FIRST NAMED INVENTOR Jun Tao 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 ATTORNEY DOCKET NO. CONFIRMATION NO. ALERE1350-l 1013 EXAMINER BOWERS, NATHAN ANDREW ART UNIT PAPER NUMBER 1799 NOTIFICATION DATE DELIVERY MODE 08/23/2018 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): gtdocket@dlapiper.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JUN TAO and HELEN GRACE HUANG Appeal2017-009066 Application 12/739,388 1 Technology Center 1700 Before JEFFREY T. SMITH, WESLEY B. DERRICK, and SHELDON M. McGEE, Administrative Patent Judges. McGEE, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134, Appellants seek our review of the Examiner's rejection of claims 1, 3-7, and 12. App. Br. 3. We have jurisdiction. 35 U.S.C. § 6. We affirm. 1 Appellants identify Alere Switzerland GmbH as the real party in interest. App. Br. 3. Appeal2017-009066 Application 12/739,388 BACKGROUND The subject matter on appeal is directed to an assay device used to detect an analyte in a liquid sample, specifically an assay device for determining the presence or absence of certain drugs in biological samples. Spec. ,r,r 44--45. Figure 1 illustrates the claimed subject matter of sole independent claim 1 and is copied below from Appellants' Specification: 500 506 502 504 514 508 Figure 1 Figure 1 depicts a perspective view of a lateral flow assay device 500 which includes a sample receiving pad 502, a conjugate pad 504, and a flow strip 506 containing a blocking capture ( or "blocking") zone 508 and a detection capture (or "detection") zone 514. Spec. ,r,r 28, 47, 51. Appellants' Figure 2 is likewise illustrative and is copied below: 2 Appeal2017-009066 Application 12/739,388 507 510 508 514 Figure 2A Figure 2A depicts a perspective view of a lateral flow assay device and shows a plurality of conjugates 507 in a mobilization zone, and binding agents 510, 516 in blocking zone 508 and detection zone 514, respectively. Spec. ,r,r 29, 50, 51. Figure 3 is also helpful in understanding the appealed subject matter and is represented below: 507 530 532 534 Figure 3 3 Appeal2017-009066 Application 12/739,388 Figure 3 depicts conjugate 507 which includes an analyte mimic 530, a linker agent 532, and a label 534. Spec. ,r 58. "Analyte mimic 530 is capable of forming a complex with binding agents ( e.g., an antibody) that also forms a complex with an analyte corresponding to the conjugate." Id. ,r 59. Analyte mimic 530 may be the analyte itself or an analog of such analyte, such as a fragment or epitope thereof. Id. ,r,r 60-61. Linker 5 3 2 links the analyte mimic 530 and the label 534. Id. ,r 62. Label 534 is the part of the conjugate that permits its detection in the detection zone 514 and may be a particle that forms a color when aggregated in the detection zone 514. Id. ,I 63. Conjugates 507 are included on conjugate pad 504 (depicted in Figure 1 ), and are retained in a dry state until they are mobilized upon application of a liquid sample on receiving pad 502. Id. ,r,r 53, 54. Once mobilized, the "conjugates flow with the sample along the flow path of device 500 to flow strip 506" where they ultimately encounter binding agents 510 and 516 at various zones (i.e., blocking capture zone 508 and detection capture zone 514). Id. ,r 54. As explained in the Specification, [ w ]hen the advancing liquid encounters binding agents 510 of first capture zone 508, analyte 540 (if present) and the conjugates 507 compete to form complexes with binding agents 510. Analyte or conjugates are captured by binding agents 510. As the amount of analyte in the liquid increases, the amount of conjugates captured by binding agents 510 decreases. The advancing liquid continues along strip 506 past first capture zone 508 to detection capture zone 514. Conjugates 507 remaining in the liquid are captured by binding agents 516 as the liquid passes through detection capture zone 514. Because increasing amounts of analyte in the liquid sample result in an increasing amount of conjugates 507 passing through the first capture zone 508, increasing amounts of analyte result in an 4 Appeal2017-009066 Application 12/739,388 increased amount of conjugates 507 being captured in detection capture zone 514. Thus, the assay device 500 is a positive-read assay device in that the presence ( or presence above a threshold) of conjugates 507 in the detection zone indicates the presence of the analyte and the absence ( or presence below a threshold) of the conjugates 507 indicates the absence of the analyte. Spec. ,r,r 77-78. Sole independent claim 1 is illustrative of the appealed subject matter, and is copied below from the Claims Appendix to the Appeal Brief, with emphasis added to relevant limitations at issue in this appeal: 1. A test device for detecting an analyte in a liquid sample, comprising[:] a matrix for supporting the liquid sample flowing thereon comprising: a) a mobilization zone comprising a conjugate having a detectable label linked to an analyte mimic, wherein the conjugate is mobilizable upon application of said liquid sample; b) a blocking zone comprising a blocking-zone binding agent immobilized thereon, said blocking-zone binding agent being capable of specifically binding the analyte mimic and an analyte corresponding to the analyte mimic, and wherein binding affinity between the analyte mimic and the blocking-zone binding agent is at least two fold higher, as measured by association constant, than that between the analyte corresponding to the analyte mimic and the blocking-zone binding agent to inhibit hook effect; and c) a detection zone comprising immobilized thereon a detection-zone binding agent that exhibits binding specificity to the conjugate. App. Br. 13. 5 Appeal2017-009066 Application 12/739,388 STATEMENT OF THE CASE The Examiner rejects claims 1, 3-7, and 12 under 35 U.S.C. § I03(a) as unpatentable over Boehringer2 in view of Bauer. 3 Relevant to this appeal, the Examiner finds, and Appellants do not dispute, that Boehringer discloses the recited test device, except for an express recitation of the limitation requiring the binding affinity between the blocking zone binding agent and the analyte mimic to be at least two fold higher than that between the binding agent and the analyte itself. Final Act. 3. The Examiner relies on disclosures contained with Boehringer and Bauer to address this deficiency. Id. at 4. Specifically, the Examiner finds that "Bauer discloses a similar lateral-flow test strip" to that of Boehringer, including "a mobilization zone, a blocking zone and a detection zone" where the analyte mimic' s binding affinity for the binding agent is higher than the binding affinity between the analyte and the binding agent. Id. Thus, according to the Examiner, Bauer discloses that "the ratio between analyte mimic binding affinity and analyte binding affinity" is a result-effective variable that the skilled artisan would optimize through no more than routine experimentation. Id. at 5---6. The Examiner also notes that Boehringer evinces that the binding affinity of the agent in the blocking zone of an assay device was one of several variables that were "optimized through routine experimentation to affect device operation in a predictable way." Id. at 4 ( citing Boehringer ,r 56). 2 US 2007/0243630 Al, published Oct. 18, 2007. 3 US 6,699,722 B2, issued March 2, 2004. 6 Appeal2017-009066 Application 12/739,388 Based on this disclosure, the Examiner concludes that it would have been well within the purview of the skilled artisan, and therefore obvious, to modify the Boehringer device to have the recited binding affinity. Id. OPINION Appellants present arguments only directed to independent claim 1. We, therefore, select this claim as representative and decide the appeal on the basis of claim 1 alone. 37 C.F.R. § 41.37 (c)(l)(iv). We have considered Appellants' arguments (App. Br. 5-11; Reply Br. 3-7) and are unpersuaded that Appellants have identified reversible error in the Examiner's rejection. In re Jung, 637 F.3d 1356, 1365---66 (Fed. Cir. 2011 ). Therefore, we sustain the obviousness rejection of claims 1, 3-7, and 12 based on the findings of fact, conclusions of law, and rebuttals to arguments well-expressed by the Examiner in the Final Action and in the Answer. We add the following. Several of Appellants' arguments center on the recited inhibition of a certain "hook effect," which, according to the Specification, is when a device is "not particularly useful for measuring analytes at high concentrations with [a] high degree of accuracy." Spec. ,r 4. Namely, Appellants first contend that because neither Boehringer nor Bauer disclose, suggest, or otherwise provide guidance for the degree of binding affinity difference that would be required in order to result in hook effect inhibition, there would have been no reasonable expectation of successfully arriving at the claimed subject matter. App. Br. 6-7. Appellants then contend that the Examiner erred in applying the doctrine of routine optimization because the binding affinity "must have been recognized as causing the alleged benefit after having been changed." Id. at 8. Appellants urge that the cited prior art 7 Appeal2017-009066 Application 12/739,388 does not teach or suggest "the claimed relationship of the variable and the result, i.e., the relationship of the claimed binding affinities and the inhibition of hook effect." Id.; Reply Br. 5 (emphasis added). These arguments do not reveal error in the Examiner's obviousness conclusion. First, we note that the prior art need not recognize Appellants' purported benefit (i.e., inhibition of hook effect) to render claim 1 obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (BP AI 1985) ("The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise have been obvious."). Moreover, we emphasize that the law does not require the prior art to recognize the precise result recited in the claims to determine that a variable is result-effective. Rather, as our reviewing court makes clear, "the prior art need not provide the exact method of optimization for the variable to be result-effective. A recognition in the prior art that a property is affected by the variable is sufficient to find the variable result-effective." In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012) (emphasis added). Here, the prior art is replete with disclosure regarding how varying the binding affinity of the reagent affects a result such as 1) sample analyte quantification (Boehringer ,r 56), 2) "good discrimination between analyte concentrations" (id. ,r,r 57, 62), 3) the efficient removal of "finite quantities of labelled antigen" (id. ,r 57), and 4) controlling analyte capture kinetics during flow (id. ,r 62). Such evidence establishes that the skilled artisan would have recognized that the binding affinity of the "blocking zone binding agent" would indeed be a result-effective variable. For these reasons, and those provided by the Examiner, Appellants have failed to identify reversible error in the Examiner's rejection of claims 8 Appeal2017-009066 Application 12/739,388 1, 3-7, and 12. We, therefore, sustain the Examiner's rejection of these claims. DECISION The Examiner's final decision to reject claims 1, 3-7, and 12 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 9 Copy with citationCopy as parenthetical citation