DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-5, 10-11, 21, 24, 28-29, 38, 43, 47, 57, 63, 65, 71, 79, 84-85, 94, 109, 122, 125, 142-143, 149 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abudayyeh et al (US 20180340219) in view of Andreyev et al (US 20160186240).
Regarding claim 1, Abudayyeh et al teach a microfluidic cartridge for detecting a target nucleic acid (Para. 0155: microfluidic) comprising: valves, channels, and chambers (Para. 0284) for amplification (Para. 0248: amplification of target nucleic acids prior to CRISPR) and detecting using CRISPR using a programmable nuclease (Para. 0181: RuvC catalytic CRISPR effector Cas9 enzyme), a guide nucleic acid (Claim 1: guide RNA to bind to target molecules), and a labeled detector nucleic acid; , wherein the labeled detector nucleic acid is capable of being cleaved upon binding of the guide nucleic acid to a segment of a target nucleic acid. (Claim 1: masking construct deactivated by cleaving the masking construct so the detectable positive signal is unmasked).
Abudayyeh is silent to the detection chamber fluidically connected to the valve, wherein the valve is connected to a sample metering channel; the detection reagent chamber fluidically connected to the detection chamber via a resistance channel.
Andreyev et al teach a molecular diagnostic fluidic device where the detection chamber fluidically connected to the valve (Fig. 9: detection module 6800 connected to rotary valve 6340), wherein the valve is connected to a sample metering channel (Fig. 9: rotary valve 6340 connected to sample prep module 6200 connected by fluidic path to meter the sample into the detection module); the detection reagent chamber fluidically connected to the detection chamber via a resistance channel (Fig. 9: reagent storage module 6700 with chambers 6701-6704 connected to the detection chamber 6821-6825 by channel from reagent module to the channel 6812, it is noted that the resistance channel has an angular path before the detection channel 6821. The detection module 6800 in Fig. 9 is the also the detection module 6800 in Figs 46-49 (Para. 0271). The angular channel 6812 is depicted in Fig. 9 as having an angle of entry to the detection chamber/channel 6812 (Para. 0272-0273), is shown in greater detail in Fig. 46 having multiple angular portions (Fig. 46: 6812) having first inlet portion 6813 and second inlet portion 6817 (Para. 0273)). It is advantageous to provide the above arrangement in a fluidic detection device because the rotary valve allows for the different sample, reagent, amplification product to mix in the detection module to provide sequentially the needed components for the detection on a chip. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the Andreyev fluidic device arrangement for the valve, channel and chambers of Abudayyeh to provide the above advantage of providing sequentially the needed components for the detection on a chip.
Regarding claim 2, Abudayyeh/Andreyev teach the sample metering channel (i) controls volumes of liquids dispensed in a channel or chamber, and (ii) is fluidically connected to the detection chamber (Andreyev: Fig. 9, Para. 0176: desired sample volume delivered to device).
Regarding claim 4, Abudayyeh/Andreyev teach the resistance channel (i) has a serpentine path, an angular path, or a circuitous path, and (ii) is fluidically connected with the valve. (Andreyev: Fig. 9: angular path and connected to the rotary valve)
Regarding claim 5, Abudayyeh/Andreyev teach the valve is a rotary valve (Andreyev: Fig. 9: rotary valve 6340).
Regarding claim 10, Abudayyeh/Andreyev teach the valve is a rotary valve that fluidically connects at least 3, at least 4, or at least 5 chambers. (Andreyev: Fig. 9: rotary valve 6340 connects at least three chamber: mixing chamber, reagent chambers, and detection chamber)
Regarding claim 11, Abudayyeh/Andreyev teach a sample chamber fluidically connected to the amplification reagent chamber (Andreyev: Fig. 9: 6200 connected to amplification module 6600).
Regarding claim 21, Abudayyeh/Andreyev teach the sample chamber is fluidically connected to the amplification chamber through the amplification reagent chamber (Andreyev: Fig. 9, para. 0224: 6200 connected to amplification module 6600 through mixing chamber 6500 having PCR reagents)
Regarding claim 24, Abudayyeh/Andreyev teach the microfluidic cartridge further comprises a reagent port above the detection chamber configured to deliver fluid from the detection reagent chamber to the detection chamber (Andreyev: Fig. 9:6700 reagent module with reagent port above 6800 detection chamber to deliver reagents to the detection module)
Regarding claim 28, Abudayyeh/Andreyev teach the resistance channel is configured to reduce backflow into the detection chamber and the detection reagent chamber. (Fig. 9: angled channels to the detection module would inherently reduce backflow by being angled)
Regarding claim 29, Abudayyeh/Andreyev teach wherein the sample metering channel is configured to direct a predetermined volume of fluid from the detection reagent chamber to the detection chamber (Para. 0306)
Regarding claim 38, Abudayyeh/Andreyev teach the microfluidic cartridge is configured to connect to a first pump to pump fluid from the amplification chamber to the detection chamber (Fig. 9: fluidic drive module 6400)
Regarding claim 43, Abudayyeh/Andreyev teach the amplification reagent chamber is connected to a second port configured to receive pneumatic pressure (Fig. 9, Para. 0241: 6500 mixing chamber receives positive or negative pressure from the plunger 6410)
Regarding claim 47, Abudayyeh/Andreyev teach the detection reagent chamber is connected to a port configured to receive pneumatic pressure (Fig. 9, Para. 0241: 6500 mixing chamber receives positive or negative pressure from the plunger 6410)
Regarding claim 57, Abudayyeh/Andreyev teach a region of the resistance channel is molded to direct flow in a direction perpendicular to the net flow direction (Fig. 9: channel from reagent module perpendicular to flow to detecting module).
Regarding claim 63, Abudayyeh/Andreyev teach the detection chamber an optically transparent surface (Andreyev Para. 0280: viewing lid colored piece of plastic).
Regarding claim 65, Abudayyeh/Andreyev teach the amplification chamber is configured to hold from 10 μL to 500 μL of fluid (Para. 0261: 160 μL volume of the flow channel).
Regarding claim 71, Abudayyeh/Andreyev teach comprising 2 detection chambers (Para. 0168; Fig. 49: 6821-6825)
Regarding claim 79, Abudayyeh/Andreyev teach further comprising a sliding valve (Para. 0198: sliding valve);
Regarding claim 84, Abudayyeh/Andreyev teach a manifold configured to accept the microfluidic cartridge of claim 1, the manifold comprising a pump configured to pump fluid into the detection chamber (Andreyev Fig. 9: Fluidic drive module), an illumination source configured to illuminate the detection chamber, a detector configured to detect a detectable signal produced by the labeled detector nucleic acid (Abudayyeh Para. 0499: biotek Neo fluorescence plate reader) , and a heater configured to heat the amplification chamber (Andreyev Para. 0257; Fig. 9: heater 6630).
Regarding claim 85, Abudayyeh/Andreyev teach the manifold further comprises a second heater configured to heat the detection chamber (Para. 0273: heater assembly 6840 of the detector module 6600)
Regarding claim 94, Abudayyeh/Andreyev teach wherein the amplification chamber comprises amplification reagents and/or lysis buffer.
Regarding claim 109, Abudayyeh/Andreyev teach the programmable nuclease comprises an RuvC catalytic domain (Para. 0181)
Regarding claim 122, Abudayyeh/Andreyev teach the microfluidic cartridge further comprising (i) one or more chambers for in vitro transcribing amplified coronavirus target nucleic acid, and (ii) reagents for in vitro transcription. (Abudayyeh: Para 0362 coronavirus; Para. 0263: in vitro transcription)
Regarding claim 125, Abudayyeh/Andreyev teach the programmable nuclease type VI CRISPR/Cas effector protein (Abudayyeh: Para. 0173: Type VI CRISPR/Cas C2c2 enzyme)
Regarding claim 142, Abudayyeh/Andreyev teach the microfluidic cartridge comprises a control nucleic acid (Para. 0096: negative control).
Regarding claim 143, Abudayyeh/Andreyev teach the control nucleic acid is in the detection chamber ((Para. 0096: negative control in the detection reaction).
Regarding claim 149, Abudayyeh/Andreyev teach the guide nucleic acid targets a plurality of target sequences (Para. 0258: guide RNA with different target nucleic acid in a single assay)
Response to Arguments
Regarding Claim Objections of claim 10 and Claim rejections under 112b for claims 85 and 149, the amendments overcome the above objections and rejections filed in the Non-final rejection on 10/1/2025.
Applicant's arguments filed 12/30/2025 regarding the Claim rejection under 35 USC 103 have been fully considered but they are not persuasive. Applicant argues Andreyev et al fails to teach the resistant channel. The detection module 6800 in Fig. 9 is the also the detection module 6800 in Figs 46-49 (Para. 0271). The angular channel 6812 is depicted in Fig. 9 as having an angle of entry to the detection chamber/channel 6812 (Para. 0272-0273), is shown in greater detail in Fig. 46 having multiple angular portions (Fig. 46: 6812) having first inlet portion 6813 and second inlet portion 6817 (Para. 0273). Andreyev et al therefore teaches the resistant channel as required for the claim.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Dennis White/Primary Examiner, Art Unit 1758