Handylab, Inc.

Patent Trials and Appeals Board

Jan 31, 2022

2021000836 (P.T.A.B. Jan. 31, 2022)

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. 14/267,232 05/01/2014 Kalyan Handique HANLB.070C1 7732 95896 7590 01/31/2022 Knobbe, Martens, Olson & Bear, LLP (BD/HANLB) 2040 Main Street 14th Floor Irvine, CA 92614 EXAMINER HASSAN, LIBAN M ART UNIT PAPER NUMBER 1799 NOTIFICATION DATE DELIVERY MODE 01/31/2022 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): efiling@knobbe.com ip.docket@bd.com jayna.cartee@knobbe.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte KALYAN HANDIQUE ____________ Appeal 2021-000836 Application 14/267,232 Technology Center 1700 ____________ Before CATHERINE Q. TIMM, DONNA M. PRAISS, and DEBRA L. DENNETT, Administrative Patent Judges. DENNETT, Administrative Patent Judge. DECISION ON APPEAL1 STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the Examiner’s decision to reject claims 1-3, 9-12, 14, and 57-71 of 1 In our Decision, we refer to the Specification (“Spec.”) of Application No. 14/267,232 filed May 1, 2014; the Non-Final Office Action dated June 11, 2019 (“Non-Final Act.”); the Appeal Brief filed May 27, 2020 (“Appeal Br.”); the Examiner’s Answer dated Sept. 15, 2020 (“Ans.”); and the Reply Brief filed Nov. 13, 2020 (“Reply Br.”). 2 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies HandyLab, Inc. as the real party in interest. Appeal Br. 3. Appeal 2021-000836 Application 14/267,232 2 Application 14/267,232, which constitute all the claims pending in this application. We have jurisdiction under 35 U.S.C. § 6(b). For the reasons set forth below, we REVERSE. CLAIMED SUBJECT MATTER The subject matter of the invention relates to high-throughput, automated execution of nucleic acid based assays in a microfluidic cartridge. Spec. ¶ 3. More specifically, the invention relates to devices for carrying out diagnostic assays on multiple biological samples in parallel to test whether an analyte of interest, e.g., a target nucleic acid, is present in a sample. Id. ¶ 49. Figs. 2 and 3 are reproduced below from the ’232 Application to aid in understanding the invention: Appeal 2021-000836 Application 14/267,232 3 Fig. 2 is a top plan view of microfluidic cartridge 200. Spec. ¶ 23. Cartridge 200 may comprise a plurality of sample lanes. Id. ¶ 68. Microfluidic cartridge 200 shown in Fig. 2 includes twelve independent sample lanes 300a-l. Id. Each sample lane 300a-l may include a microfluidic network having an inlet, microfluidic valves, microfluidic gates, channels, and reaction chambers, such as one or more amplification chambers, and a plurality of detection chambers. Id., ¶ 69. Fig. 3 shows a single sample lane, the sample lane being part of the microfluidic network of the microfluidic cartridge of Fig. 2. Id., ¶ 24. Each sample lane 300a-l can be conceptually divided into a first stage 206 and a second stage 208. Id., ¶ 69. The sample lane 300 comprises a microfluidic network, the microfluidic network including an inlet 302, microfluidic valves 330a, 330b, 370a, and 370b, microfluidic gates 310a and 310b, microfluidic channels 360, 364, 366, and 374, an amplification chamber 362, and six detection chambers 372a-f. Id., ¶ 72. Claim 1, reproduced below from the Claims Appendix of the Appeal Brief, represents the claimed subject matter: Appeal 2021-000836 Application 14/267,232 4 1. A microfluidic cartridge comprising: a plurality of sample lanes, each lane comprising a microfluidic network having: an inlet; a single amplification chamber, wherein the single amplification chamber is configured to be heated in which polynucleotides in a sample are amplified within the single amplification chamber; a first amplification valve upstream of the single amplification chamber; a second amplification valve downstream of the single amplification chamber; a first channel fluidically transmitting the sample from the inlet, via the first amplification valve, to the single amplification chamber; a plurality of detection chambers downstream of the single amplification chamber; a first detection valve downstream of the single amplification chamber and upstream of the plurality of detection chambers, wherein the first detection valve is spatially separated from the second amplification valve; a second detection valve downstream of the plurality of detection chambers, wherein the only entrance to the plurality of detection chambers is through the first detection valve and the only exit from the plurality of detection chambers is through the second detection valve; and a second channel fluidically transmitting the sample from the single amplification chamber, via the first detection valve, to two or more subchannels, each subchannel connecting to one of the plurality of detection chambers, wherein the two or more subchannels are configured to allow filling of two or more detection chambers of the plurality of detection chambers with the sample from the Appeal 2021-000836 Application 14/267,232 5 single amplification chamber, and wherein the second amplification valve is closed when the sample is transmitted from the single amplification chamber to the plurality of detection chambers downstream of the single amplification chamber. REFERENCES The Examiner relies on the following prior art in rejecting the claims as obvious under 35 U.S.C. § 103(a): Name Reference Date Woudenberg et al. (“Woudenberg”) US 2005/0158781 A1 July 21, 2005 Nakajima et al. (“Nakajima”) US 2006/0094004 A1 May 4, 2006 Handique US 2009/0047713 A1 Feb. 19, 2009 Battrell et al. (“Battrell”) US 2009/0148933 A1 June 11, 2009 REJECTIONS The Examiner maintains the rejection of claims under 35 U.S.C. § 103(a)3 as follows: (1) claims 1-3, 9-12, 14, and 57-68 over Battrell in view of Handique and Nakajima; and (2) claims 69-71 over Battrell in view of Handique and Nakajima, and further in view of Woudenberg. Non-Final Act. 3-24. 3 We note that Appellant properly appeals from the Examiner’s non-final rejection of June 11, 2019 because the claims on appeal have been twice rejected. See 35 U.S.C. § 134(a)(“[a]n applicant for a patent, any of whose claims has been twice rejected, may appeal from the decision of the primary examiner to the Patent Trial and Appeal Board.”). Appeal 2021-000836 Application 14/267,232 6 OPINION All of the claims require either a single amplification chamber (claims 1-3, 9-12, 14. 57-62, 69, and 70) or one isolatable amplification chamber (claims 63-68 and 71) in each of a plurality of sample lanes. Appeal Br. 27- 31 (Claims App.). The Examiner relies on Battrell to disclose these limitations. Non-Final Act. 4, 18; Ans. 4. The Examiner provides an annotated version of Battrell Figure 4 that identifies Battrell’s “PCR fluidics and thermal interface assembly” as the single amplification chamber. Non- Final Act. 4. Battrell’s Figure 4 is a schematic of an integrated device combining subcircuits for microfluidic extraction, PCR amplification, and detection. Battrell ¶ 49. The amplification subcircuit is in the middle of the drawing and comprises two chambers within each arm (of which there are seven Appeal 2021-000836 Application 14/267,232 7 depicted) of the PCR fluidics and thermal interface assembly. Id. ¶¶ 190, 192. Each of the arms comprises a separate inlet valve and outlet valve. Id. ¶ 196. All of the outlet valves lead to a mixer, which leads to a detection chamber. Id. ¶¶ 198, 201. In the Non-Final Action, the Examiner finds that Battrell’s microfluidic cartridge includes one reaction chamber. Non-Final Act. 4. In the Answer, the Examiner finds that Battrell’s cartridge includes a single amplification chamber arranged in a sample lane, and includes additional sample lanes comprising additional single amplification chambers. Ans. 4. Appellant argues, inter alia, that the cited references do not teach a single or one isolatable amplification chamber in one lane of a plurality of lanes. Appeal Br. 14. Appellant argues that Battrell discloses seven arms of the PCR fluidics and thermal interface assembly, each arm having two bellows chambers with separate temperature requirements critical for the PCR protocol. Reply Br. 1. Appellant’s arguments are persuasive of reversible error. The Examiner misinterprets the claim language in allowing Battrell’s multiple chambers to read on “a single amplification chamber” (or “one isolatable amplification chamber”) of the claims. The seven arms of Battrell’s PCR fluidics and thermal interface assembly, each having two bellows chambers, do not constitute a single amplification chamber merely because their output is mixed together before entering the detection chamber. To the extent that the Examiner appears to rely in the Answer on only one arm of Battrell’s PCR fluidics and thermal interface assembly as meeting the single amplification chamber limitation, each arm comprises Appeal 2021-000836 Application 14/267,232 8 two-not one-bellows chambers, thus does not meet the “single” amplification chamber requirement. Moreover, the interpretation of each arm of Battrell’s assembly as a separate sample lane would change Battrell’s principle of operation of mixing the products of amplification for multiplex detection at the detection station. See Battrell ¶ 208. For the reasons above, we do not sustain the rejection of claims 1-3, 9-12, 14, and 57-68 as obvious over Battrell in view of Handique and Nakajima. Because the Examiner relies on the same findings regarding Battrell in the rejection of claims 69-71, we do not sustain the rejection of these claims as obvious over Battrell, Handique, Nakajima, and Woudenberg. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-3, 9-12, 14, 57-68 103(a) Battrell, Handique, Nakajima 1-3, 9-12, 14, 57-68 69-71 103(a) Battrell, Handique, Nakajima, Woudenberg 69-71 Overall Outcome 1-3, 9-12, 14, 57-71 REVERSED