Ex Parte ReganDownload PDFPatent Trials and Appeals BoardSep 20, 201613607494 - (D) (P.T.A.B. Sep. 20, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/607,494 09/07/2012 John Frederick Regan 24981 7590 09/22/2016 Lawrence Livermore National Security, LLC LA WREN CE LIVERMORE NA TI ON AL LABORATORY PO BOX 808, L-703 LIVERMORE, CA 94551-0808 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. IL-l 1778B 9895 EXAMINER FORMAN, BETTY J ART UNIT PAPER NUMBER 1634 NOTIFICATION DATE DELIVERY MODE 09/22/2016 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): llnl-docket@llnl.gov PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN FREDERICK REGAN1 Appeal2014-008022 Application 13/607,494 Technology Center 1600 Before FRANCISCO C. PRATS, JOHN G. NEW, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to methods of detecting genetic sequences, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. STATEMENT OF THE CASE According to the Specification, "[ t ]he present invention provides a system [and method] for detecting different genetic assays in a sample." (Spec. i-f 11; see also id. at i-f 12.) Claims 1 and 5 are on appeal. Claim 1 is illustrative: 1 Appellant identifies the Real Parties in Interest as Lawrence Livermore National Security, LLC and the United States of America. (App. Br. 2.) Appeal2014-008022 Application 13/607,494 1. A method of detecting different genetic sequences in a sample, consisting of the steps of: providing a flow channel, providing an optical detector having a multiplicity of optical windows operatively connected to said flow channel that detects different genetic sequences, providing a sample source, providing a multi-barrel cartridge, providing sources of reagent fluids that produce reagent plugs in said flow channel, associating sample preparation fluids with the sample, associating the sample with the reagent plugs forming sample-reagent plugs, providing a sample multi-position valve for receiving and processing the sample, said sample multi-position valve connected to said optical detector, and to said sources of reagent fluids, to said multi-barrel cartridge, and to said sample source, providing a reagent multi-position valve connected to said sources of reagent fluids, to said multi-barrel cartridge, and to said sample multi-position valve, providing a control operatively connected to said flow channel, said optical detector, said sample source, said sources of reagent fluids, said sample multi-position valve, said multi- barrel cartridge, and said reagent multi-position valve that produces said reagent plugs and said sample-reagent plugs in said fl ow channel, using said control for positioning said sample-reagent plugs in operative position to the multiplicity of optical windows in the detector for detecting different genetic sequences in the sample, amplifying said sample-reagent plugs, and detecting the different genetic sequences in the sample in said sample-reagent plugs. (App. Br. 17 (Claims App'x) (emphasis added).) 2 Appeal2014-008022 Application 13/607,494 The claims stand rejected as follows: I. Claim 1under35 U.S.C. § 103(a) over Cox,2 Colston,3 Collins,4 and Shigesada. 5 II. Claims 1 and 5 under 35 U.S.C. § 103(a) over Cox, Colston, Collins, Shigesada, and Haff. 6 On appeal, we determine whether the Examiner established by a preponderance of the evidence that claims 1 and 5 would have been obvious according to Rejections I and II above. DISCUSSION Rejection I The Examiner has rejected claim 1 as obvious over Cox, Colston, Collins, and Shigesada. The Examiner finds that Cox teaches a method for detecting different genetic sequences with steps that overlap with the steps recited in claim 1. (Ans. 2-3.) The Examiner relies on Colston for "teaching of a single element (i.e.[,] optical windows) that is missing from the Cox reference." (Id. at 7-8.) The Examiner relies on Collins and Shigesada for "teaching of a single element (i.e.[,] extraction column) that is missing from the Cox reference." (Id. at 8-9; see also id. at 3--4 ("Collins discloses a removable cartridge for an automated nucleic acid extraction and 2 Cox et al., US 2007/0068573 Al, published Mar. 29, 2007 ("Cox"). 3 Colston et al., WO 03/027325 A2, published Apr. 3, 2003 ("Colston"). 4 Collins, US 2005/0136442 Al, published June 23, 2005 ("Collins"). 5 Shigesada et al., US 2007/0148649 Al, published June 28, 2007 ("Shigesada"). 6 Haff et al., US 5,720,923, issued Feb. 24, 1998 ("Haff'). 3 Appeal2014-008022 Application 13/607,494 purification system comprising a flow-through cartridge ... that includes a plurality of barrels .... ").) The Examiner concludes it would have been obvious to modify the method of Cox with the optical windows of Colston and the extraction columns/multi-barrel cartridges taught in Collins or Shigesada. (Ans. 3--4.) According to the Examiner, "[i]t would have been obvious ... to apply the optical windows of Colston to the optical detection of Cox" given the well- known use of such windows in nucleic acid assay systems. (Id. at 3.) Moreover, according to the Examiner, the "artisan would have been motivated to select the cartridge of Collins for the expected benefit of [a] multi-level and recycling purification system to obtain the desired purification .... [or] would have been motivated to select the cartridge of Shigesada for the expected benefit of rapid and simple extraction and delivery of nucleic acids." (Id. at 4.) We agree with the Examiner's fact-finding, reasoning, and conclusion that claim 1 would have been obvious based on the cited references. Appellant does not challenge that the prior art discloses the limitations of pending claim 1, nor does Appellant challenge the Examiner's reasoning for combining the teachings from the applied prior art. Instead, Appellant points out that claim 1 recites "a 'consisting of' preamble [that] is a closed term" and argues that the obviousness rejection is flawed because the Examiner's "proposed combination of the references includes claim elements/steps in addition to the specific combination of claim elements/steps of Appellant's claim 1." (App. Br. 7-8 (emphasis added).) More specifically, Appellant contends the "proposed combination of 4 4 Appeal2014-008022 Application 13/607,494 references accumulates all the additional steps of the 4 references." (Reply Br. 2.) Appellant lists excerpts from each of Cox, Colston, Collins, and Shigesada, which Appellant argues illustrate "claim elements/steps in addition to Appellant's claim 1 claim elements/steps." (App. Br. 8-12.) And, according to Appellant, "only one extra claim element/step in the proposed combination of the references need be established for Appellant to show that the proposed combination of references does not support a 35 USC§ 103(a) rejection of claim 1." (Id. at 8.) Appellant's arguments are unpersuasive. As an initial matter, we disagree with Appellant's contention that the rejection "accumulates" wholesale the steps of all four cited references. (See Reply Br. 2 and 4---6.) Rather, as correctly pointed out by the Examiner, the rejection relies on Colston for one missing limitation, and Collins or Shigesada for another. (Ans. 7-9.) Appellant's position is thus inconsistent with the rejection, which does not require all the features of the prior art be merged into one amalgamated system or method to support a case of prima facie obviousness. Cf In re Keller, 642 F.2d 413, 425 (CCPA 1981) ("[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference"). So, insofar as Appellant cites to excerpts of Colston, Collins, or Shigesada, which relate to steps or features the Examiner is not proposing be included in the modified method of Cox, Appellant's arguments are not persuasive. In response to Appellant's citation of several excerpts in Cox that allegedly reflect "claim elements/steps in addition" to the steps in claim 1, the Examiner finds that those "additional" steps are optional in Cox or 5 Appeal2014-008022 Application 13/607,494 otherwise still within the broad steps recited in claim 1. (Ans. 5-7.) We agree with the Examiner. For example, Appellant cites to a disclosure in Cox that "[a]ccording to various embodiments, fluid processing system 10 can comprise a spacing fluid tube system .... " (App. Br. 8 (emphasis added).) The excerpt cited by Appellant thus shows that "the method of Cox does not limit the system or methods for using the system to the additional element" - in other words, the system can include, but does not require, the cited spacing fluid tube system. (Ans. 6.) The other excerpts similarly fail to persuade us that Cox teaches steps that are required and outside the scope of claim 1. For example, Appellant cites to steps in Cox where pumps and conduits are used for separating liquids. (App. Br. 9-10 (quoting portions ofclaim 1 of Cox).) Cox, however, confirms that these structures/steps too are not required. (See, e.g., Cox. i-fi-174--81 ("According to some embodiments fluid processing system 10 can comprise pumps 39 and 40." (emphases added).) Also, given the breadth of Appellant's claim, which recites generic steps like "providing a sample source," "providing sources of reagent fluids that produce reagent plugs in said flow channel" and "associating the sample with the reagent plugs," the Examiner reasonably interpreted claim 1 as not excluding a method with pumps and conduits arranged as in the cited excerpts of Cox. (Ans. 8.) Appellant has cited additional excerpts from each of Colston, Collins, and Shigesada, but here again, the Examiner found "that each of the [alleged additional] steps is encompassed by the instantly claimed method." (Ans. 7- 9.) For example, Appellant cites to teachings in Colston of "providing a 6 Appeal2014-008022 Application 13/607,494 PCR reactor means for amplifying said sample" and "providing a detection means for detection of PCR amplicon." (App. Br. 11.) The Examiner, however, finds that these steps in Colston are encompassed by claim 1 's broad recitation of "amplifying said sample-reagent plugs, and detecting the different genetic sequences in the sample in said sample-reagent plugs." (Ans. 8.) Appellant argues "claim 1 step ... does not mention 'PCR' or 'PCR reactor means."' (Reply Br. 4.) Yet this argument does not persuasively address the Examiner's interpretation of the claimed "amplifying" and "detecting" steps as being broad enough to cover the cited steps of Colston. Where, as here, the claim uses generic language to describe the steps of "amplifying" and "detecting," the claim does not exclude use of PCR. 7 In the face of the Examiner's factual findings and claim interpretation, Appellant never attempts to explain how pending claim 1 excludes or is incompatible with the alleged "extra claim elements/steps" in Cox, Colston, Collins, or Shigesada. To the contrary, Appellant merely quotes excerpts and repeats the contention that "[s]ince the [Cox, Colston, Collins, Shigesada] reference includes claim elements/ steps in addition to Appellant's claim 1 claim elements/steps, the [Cox, Colston, Collins, and Shigesada] reference does not support a 35 USC §103(a) rejection." (App. Br. 10-12; see also, e.g., Reply Br. 4 ("Since this is an additional step 7 The Specification is consistent with the Examiner's determination that the claimed method does not exclude PCR. The Specification discloses that "[g]enetic amplification can generally be divided into polymerase chain reaction (PCR)-based assays and isothermal amplification assays, both of which can be performed by the Diagnostic System (10)." (Spec. i-f 44.) 7 Appeal2014-008022 Application 13/607,494 disclosed in the Cox reference that is additional to Appellant's claim 1 combination of steps, the Cox reference does not support a 3 5 USC § 103 (a) rejection.").) Accordingly, on the record before us, Appellant has not provided persuasive argument or evidence to show that the Examiner's findings, claim interpretation, and conclusion of obviousness are incorrect. For the above reasons, we conclude that the Examiner established by a preponderance of the evidence that claim 1 would have been obvious over Cox, Colston, Collins, and Shigesada. Rejection II The Examiner rejected claims 1 and 5 as obvious over Cox, Colston, Collins, and Shigesada (as discussed above), in further view of Haff. (Ans. 4--5.) According to the Examiner, "Haff is cited for a teaching of a single element (i.e.[,] using decontamination fluids to clean components of a PCR device) that is missing from the Cox reference." (Ans. 10.) Appellant repeats the arguments concerning Cox, Colston, Collins, and Shigesada, which we find unpersuasive for the reasons discussed above. We similarly reject Appellant's contention that "the proposed combination of references accumulates all of [the] additional steps of the 5 references." (Reply Br. 7.) As noted, the Examiner relies on Haff only for its teaching related to "providing decontamination fluids" as in claim 5. Similar to the arguments concerning other references, Appellant cites numerous excerpts of Haff and contends these are "claim elements/steps in addition to Appellant's claims 1 and 5 claim elements/steps." (App. Br. 5.) Claim 1 does not recite decontamination steps that involve providing and using decontaminating fluids, and the Examiner has not pointed to any 8 Appeal2014-008022 Application 13/607,494 other step of claim 1 that encompasses the relied-upon teaching of Haff. The Examiner's modification of the system and method of Cox to include such decontamination steps thus takes the proposed combination outside the "closed" scope of claim 1. We reverse Rejection II as to claim 1. We affirm the rejection, however, as to claim 5. Concerning the excerpts of Haff cited by Appellant, the Examiner finds these excerpts are "encompassed by the claimed 'amplifying"' step of claim 5. (Ans. 10.) The Examiner finds "[a]dditionally, the cited steps are components of the 'third embodiment' of Haff ... [and] [n]one of the other embodiments are defined by or even include the cited steps." (Id.) In other words, "the teaching of Haff is not limited to [the] additional steps cited by Appellant." (Id.) Appellant has provided insufficient persuasive argument or evidence to the contrary. We thus conclude the Examiner established by a preponderance of the evidence that claim 5 would have been obvious over Cox, Colston, Collins, Shigesada, and Haff. SUMMARY We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) over Cox, Colston, Collins, and Shigesada. We affirm the rejection of claim 5 (but not claim 1) under 35 U.S.C. § 103(a) over Cox, Colston, Collins, Shigesada, and Haff. 9 Appeal2014-008022 Application 13/607,494 TIME PERIOD FOR RESPONSE 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 10 Copy with citationCopy as parenthetical citation