Prosecution Insights
Last updated: April 19, 2026
Application No. 18/334,327

METHODS AND COMPOSITIONS FOR PERFORMING A DETECTION ASSAY

Non-Final OA §103§DP
Filed
Jun 13, 2023
Examiner
VANN-OJUEKAIYE, KENDRA RAYCHELL
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Mammoth Biosciences Inc.
OA Round
1 (Non-Final)
0%
Grant Probability
At Risk
1-2
OA Rounds
3y 2m
To Grant
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 8 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
61 currently pending
Career history
69
Total Applications
across all art units

Statute-Specific Performance

§101
13.1%
-26.9% vs TC avg
§103
41.9%
+1.9% vs TC avg
§102
8.9%
-31.1% vs TC avg
§112
20.2%
-19.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 8 resolved cases

Office Action

§103 §DP
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. Election/Restrictions Applicant’s election without traverse of Group I, claims 1-5,7-12,15-16 and 28-29, drawn to a system for detecting any of a plurality of different target nucleic acids in a sample, in the reply filed on 01/06/2026 is acknowledged. Claims 35-36,38-39, 71 and 76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II , drawn to methods of assaying target nucleic acids in a sample , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/06/2026. Claims Status Claims 1-5,7-12,15-16,28-29,35-36,38-39,71 and 76 are pending. Claims 35-36,38-39,71 and 76 are withdrawn. Claims 1-5,7-12,15-16 and 28-29 are currently under examination Priority This application claims the benefit of U.S. Provisional Application Serial No. 63/127,078 filed on December 17, 2020; U.S. Provisional Application Serial No. 63/146,508 filed on February 5, 2021; U.S. Provisional Application Serial No. 63/151,592 filed on February 19, 2021; and U.S. Provisional Application Serial No. 63/222,377 filed on July 15, 2021. The priority date of claim set filed on April 19, 2024 , is determined to be December 17, 2020 . Claim Rejections - 35 USC § 103 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. Claim s 1-5, 8, 10-12, 15-16 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Gootenberg et al. (“ Gootenberg ”; Patent App. Pub. WO 2020186231 A2, Sept. 17, 2020). Gootenberg discloses “Systems and methods for rapid diagnostics related to the use of CRISPR effector systems and optimized guide sequences, including multiplex lateral flow diagnostic devices and methods of use, are provided.” (Abstract). Regarding claim 1, Gootenberg teaches a system comprising “ the lateral flow device is capable of detecting three different target nucleic acid sequences ” (Para. 21). Thus, Gootenberg teaches a system for detecting any of a plurality of different target nucleic acids in a sample. Regarding claim 1, Gootenberg teaches a system comprising “ a lateral flow device is provided comprising a substrate comprising … a detectable ligand … CRISPR effector system … detection constructs, and one or more first capture regions, each comprising a first binding agent; and the substrate comprising two or more second capture regions between the first region of the first end and the second end, each second capture region comprising a different binding agent … CRISPR effector systems comprises a CRISPR effector protein … and one or more guide sequences, each guide sequence configured to bind one or more target molecules. ” (Para. 9 ). Gootenberg teaches a system comprising “the guide molecule comprises non-naturally occurring nucleic acids” (Para. 186). Furthermore, Gootenberg teaches a system comprising “Intact reporter construct is bound at the first capture region by binding between the first binding agent and the first molecule. Likewise, the detection agent will begin to collect at the first binding region by binding to the second molecule on the intact reporter construct. If target molecule(s) are present in the sample, the CRISPR effector protein collateral effect is activated. As activated CRISPR effector protein comes into contact with the bound reporter construct, the reporter constructs are cleaved, releasing the second molecule to flow further down the lateral flow substrate towards the second binding region. The released second molecule is then captured at the second capture region by binding to the second binding agent, where additional detection agent may also accumulate by binding to the second molecule.” (Para. 227). “ a lateral flow device… comprising a substrate ” read on a surface . “CRISPR effector protein” reads on programmable nuclease. “ bound at the … capture region” reads on immobilized. Thus, Gootenberg teaches a system comprising (a) a plurality of different non-naturally occurring guide nucleic acids, wherein each of the different non-naturally occurring guide nucleic acids is immobilized to a surface at a known location identified with the particular non-naturally occurring guide nucleic acid; (b) a plurality of reporters immobilized to the surface in proximity to each of the different non-naturally occurring guide nucleic acids at each of the known locations; wherein each of the different non-naturally occurring guide nucleic acids comprises a sequence that hybridizes to a segment of one of the plurality of different target nucleic acids or an amplicon thereof; wherein each of the non-naturally occurring guide nucleic acids is effective to form a complex with a programmable nuclease that is activated upon binding the corresponding target nucleic acid or amplicon thereof at the known location; and wherein formation of the activated complex is effective to induce detectable trans cleavage of the reporters at the respective known location. The teachings of Gootenberg are documented above in the rejection of claim 1 under 35 U.S.C. 103. Claims 2, 11-12, 15-16 and 28-29 depend on claim 1 . Claims 8 and 10 depend on claim 5. Claims 3-5 depend on claim 2, which depends on claim 1. Regarding claim s 2 -3 , Gootenberg teaches a system wherein “ a guide is modified to comprise a chemical moiety at its 3’ and/or 5’ end. Such moieties include, but are not limited to amine … the chemical moiety is conjugated to the guide by a linker, such as an alkyl chain. In certain embodiments, the chemical moiety of the modified guide can be used to attach the guide to another molecule, such as DNA, RNA, protein, or nanoparticles. ” (Para. 1 86 ). “ used to attach the guide to another molecule, such as DNA, RNA, protein, or nanoparticles” reads on a covalent bond, a non-covalent bond, an electrostatic bond, a bond between members of a binding pair, an amide bond . Thus, Gootenberg suggests a system wherein the plurality of different non-naturally occurring guide nucleic acids are each immobilized to the surface by a linkage ; an d wherein the linkage comprises a covalent bond, a non- covalent bond, an electrostatic bond, a bond between members of a binding pair, an amide bond, or any combination thereof. Regarding claim 4, Gootenberg teaches a system wherein “ a guide is modified to comprise a chemical moiety at its 3’ and/or 5’ end... the chemical moiety is conjugated to the guide by a linker, such as an alkyl chain ” (Para. 186 ). “ an alkyl chain” reads on chain of at least 6 carbons, or at least 12 carbons. Thus, Gootenberg suggests a system wherein the linkage comprises a chain of at least 6 carbons, or at least 12 carbons. Regarding claim s 5 and 8 , Gootenberg teaches a system wherein “DNA linkers extending from the surface” and “ a first DNA linker ” (Para. 86) and “ssDNA bridge” (Para. 86). Thus, Gootenberg suggests a system wherein the linkage comprises a linker polynucleotide; and wherein the linker polynucleotide comprises single-stranded DNA. Regarding claim 10, Gootenberg teaches a system wherein “Upon activation of the CRISPR effectors disclosed herein, the ssRNA or ssDNA bridge will be cleaved” ( Para. 86 ). Thus, Gootenberg suggests a system wherein the linker polynucleotide is a cleavage substrate for the activated complex. Regarding claim 11, Gootenberg teaches a system wherein “ A first binding agent that specifically binds the first molecule of the reporter construct is fixed or otherwise immobilized to the first capture region. The second capture region is located towards the opposite end of the lateral flow substrate from the first capture region. A second binding agent is fixed or otherwise immobilized at the second capture region. The second binding agent specifically binds the second molecule of the reporter construct, or the second binding agent may bind a detectable ligand. ” (Para. 60 ). Thus, Gootenberg suggests a system wherein the reporters and the non- naturally occurring guide nucleic acids are immobilized at separate discrete positions within each of the known locations. Regarding claim 12, Gootenberg teaches a system wherein “ Upon activation of the effector proteins disclosed herein, the RNA or DNA oligonucleotide is cleaved thereby severing the proximity between the fluorophore and quencher needed to maintain the contact quenching effect. Accordingly, detection of the fluorophore may be used to determine the presence of a target molecule in a sample ” (Para. 87 ). Thus, Gootenberg suggests a system wherein a) each of the reporters comprises a fluorescent label and a quencher, and wherein cleavage of the reporters is effective to produce a detectable loss of the quencher from the respective known location, or b) each of the reporters comprises a detection moiety, and wherein cleavage of the reporters is effective to produce a detectable loss of the detection moiety from the respective known location. Regarding claim 15, Gootenberg teaches a system wherein “ a lateral flow device is provided comprising a substrate comprising a first end and a second end, the first end comprising a sample loading portion, a first region comprising a detectable ligand, two or more CRISPR effector systems, two or more detection constructs, and one or more first capture region ” (Para. 9 ). Thus, Gootenberg suggests a system further comprising programmable nucleases immobilized at the known locations by a linkage, wherein the plurality of different non-naturally occurring guide nucleic acids are immobilized to the surface by being releasably bound by the programmable nucleases. Regarding claim 16, Gootenberg teaches a system wherein “ CRISPR effector complex ” (Para. 62 ). Thus, Gootenberg suggests a system further comprising programmable nucleases bound to the non-naturally occurring guide nucleic acids. Regarding claim s 28 -29 , Gootenberg teaches a system wherein “a lateral flow device is provided comprising a substrate” (Para. 9). Gootenberg teaches a system wherein “ Exemplary discrete volumes or spaces useful in the disclosed methods include… hydrogel beads or other polymer structures (for example poly-ethylene glycol di-acrylate beads or agarose beads) ” (Para. 251 ). Thus, Gootenberg suggests a system wherein the surface is a surface of a fluidic chamber or a bead ; and wherein the surface comprises a polymer matrix. Therefore, the invention as recited in claims 1-5, 8, 10-12, 15-16 and 28-29 is prima facie obvious over the prior art Gootenberg et al. One of ordinary skill in the art would have had a reasonable expectation of success given the obviousness of the claim elements of the system were known in the art before the effective filing date. It would have been obvious to provide a system for detecting any of a plurality of different target nucleic acids in a sample according to the limitations of the instant application claims 1-5, 8, 10-12, 15-16 and 28- 29 based on Gootenberg (Patent App. Pub. No. WO 2020186231 A2 ). Clai ms 5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gootenberg et al. (“ Gootenberg ”; Patent App. Pub. WO 2020186231 A2, Sept. 17, 2020) as applied to claim 1 , and further in view of Gayet et al. ( “ Gayet ” ; (2020). Creating CRISPR-responsive smart materials for diagnostics and programmable cargo release. Nature protocols , 15 (9), 3030-3063. ). The teachings of Gootenberg are documented above in the rejection of claim 1-5, 8, 10-12, 15-16 and 28-29 under 35 U.S.C. 103. Claims 2, 11-12, 15-16 and 28-29 depend on claim 1. Claim 9 depends on claim 8. Claims 7-8 depend on claim 5 , which depend s on claim 2, which depends on claim 1. Furthermore, regarding claims 5 and 7-9, Gootenberg teaches a system wherein “Various modifications and variations of the described methods, pharmaceutical compositions, and kits of the invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific embodiments, it will be understood that it is capable of further modifications and that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention that are obvious to those skilled in the art are intended to be within the scope of the invention.” (Para. 330). Gootenberg does not explicitly teach a system according to the limitations of claims 7-9. Gayet discloses “Materials that sense and respond to biological signals in their environment have a broad range of potential applications in drug delivery, medical devices and diagnostics. Nucleic acids are important biological cues that encode information about organismal identity and clinically relevant phenotypes such as drug resistance. We recently developed a strategy to design nucleic acid–responsive materials using the CRISPR-associated nuclease Cas12a as a user-programmable sensor and material actuator. This approach improves on the sensitivity of current DNA-responsive materials while enabling their rapid repurposing toward new sequence targets. Here, we provide a comprehensive resource for the design, synthesis and actuation of CRISPR-responsive hydrogels. First, we provide guidelines for the synthesis of Cas12a guide RNAs (gRNAs) for in vitro applications. We then outline methods for the synthesis of both polyethylene glycol-DNA (PEG-DNA) and polyacrylamide-DNA (PA-DNA) hydrogels, as well as their controlled degradation using Cas12a for the release of cargos, including small molecules, enzymes, nanoparticles and living cells within hours. Finally, we detail the design and assembly of microfluidic paper-based devices that use Cas12a-sensitive hydrogels to convert DNA inputs into a variety of visual and electronic readouts for use in diagnostics. Following the initial validation of the gRNA and Cas12a components (1 d), the synthesis and testing of either PEG-DNA or PA-DNA hydrogels require 3–4 d of laboratory time. Optional extensions, including the release of primary human cells or the design of the paper-based diagnostic, require an additional 2–3 d each.” (Abstract). Regarding claims 5, 7-8, Gayet teaches a system wherein “Trigger/scrambled dsDNA + ssDNA linker” (Figure 5). Thus, Gayet suggests a system wherein the linkage comprises a linker polynucleotide; wherein the linker polynucleotide is double-stranded; and wherein the linker polynucleotide comprises double-stranded DNA or single-stranded DNA. Regarding claim 9, Gayet teaches a system wherein “The linker strand has two 15-bp regions that bind to X and Y, separated by a 15-bp sequence consisting of a (TTATT)3 motif (Fig. 5).” (Pg. 3050, Nanoparticle release from CRISPR-responsive polyacrylamide-DNA hydrogels, Para. 1; Fig. 5). Note, "Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (MPEP 2144.05). Thus, Gayet suggests a system wherein the double-stranded DNA linker polynucleotide is about 60 to about 80 base pairs in length. Gootenberg and Gayet are both considered to be analogous to the claimed invention because they are in the same field of diagnostics devices using CRISPR systems to detect nucleic acids targets with high sensitivity. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for detecting any of a plurality of different target nucleic acids in a sample as taught by Gootenberg to incorporate the suggested system elements of a linker polynucleotide comprises double-stranded DNA or single-stranded DNA and double-stranded DNA linker polynucleotide is optimizable to about 60 to about 80 base pairs in length as taught by Gayet and provide system for detecting any of a plurality of different target nucleic acids in a sample, wherein the plurality of different non-naturally occurring guide nucleic acids are each immobilized to the surface by a linkage, wherein the linkage comprises a linker polynucleotide , wherein the polynucleotide could comprise double-stranded DNA or single-stranded DNA of about 60-80 bp in length . These claim elements were known in the art and one of skill in the art could have combined these elements by known methods and optimized variables by routine experimentation with no change in their respective functions, and the combination would have yielded the predictable outcome according to the limitations of claims 5 and 7-9 . Doing so would allow for CRISPR–Cas sensing elements can be interfaced with a range of materials by incorporating DNA crosslinkers into the scaffold of the device. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 and 44 of copending Application No. 18/055814 in view of Gootenberg et al. (“ Gootenberg ”; Patent App. Pub. WO 2020186231 A2, Sept. 17, 2020) . Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is made obvious over the claims of copending Application No. 18/055814 in view of Gootenberg . The claims of copending Application No. 18/055814 are drawn to: “ 1. A system for detection of a target nucleic acid, comprising: a. an enclosure. a reagent chamber disposed within the enclosure; a programmable nuclease and a guide nucleic acid disposed within the reagent chamber, wherein the guide nucleic acid is complementary to the target nucleic acid or a portion thereof, wherein the programmable nuclease is configured to be activated through binding of the guide nucleic acid to the target nucleic acid; c. d. a reporter disposed within the reagent chamber, wherein the reporter comprises a cleavable nucleic acid and a detection moiety, wherein cleavage of the cleavable nucleic acid by the activated programmable nuclease releases the detection moiety from the cleavable nucleic acid; and e. a lateral flow assay strip disposed within the enclosure; the lateral flow assay strip comprising a sample pad and a detection region, wherein the detection region comprises a stationary capture probe disposed thereon and configured to capture the released detection moiety, wherein release of the detection moiety directly or indirectly produces a detectable signal at a location corresponding to the stationary capture probe. 44. The system of claim 43, wherein the programmable nuclease, the guide nucleic acid, and/or the reporter is immobilized to the surface by a linker. ” The teachings of Gootenberg are documented above in the rejection of claim 1-5, 8, 10-12, 15-16 and 28-29 under 35 U.S.C. 103. Therefore, the invention as recited in claims 1 is prima facie obvious over the copending Application No. 18/055814 in view of Gootenberg . One of ordinary skill in the art would have had a reasonable expectation of success given the claims of copending application. It would have been obvious to provide a system for detecting any of a plurality of different target nucleic acids in a sample according to the limitations recited in claim 1 of the instant application based on claims 1 and 44 of copending Application No. 18/055814 in view of Gootenberg . This is a provisional nonstatutory double patenting rejection. Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 76 of copending Application No. 18/058122 in view of Gootenberg et al. (“ Gootenberg ”; Patent App. Pub. WO 2020186231 A2, Sept. 17, 2020) . Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is made obvious over the claims of copending Application No. 18/058122 in view of Gootenberg . The claims of copending Application No. 18/058122 are drawn to: “ 1. (Previously Presented) A device for detecting a target nucleic acid, comprising: a. a sample interface configured to receive a sample comprising a target nucleic acid; b. a heating region in fluid communication with the sample interface and configured to amplify the sample received via the sample interface; c. a detection region in fluid communication with the heating region; d. a programmable nuclease probe disposed within the sample interface, the heating region, or the detection region, wherein the programmable nuclease probe comprises a programmable nuclease and a guide nucleic acid; and e. a reporter; wherein the programmable nuclease is activated by selective binding between the guide nucleic acid and the target nucleic acid within the heating region, the sample interface, or the detection region; wherein the reporter is configured to release a detection moiety upon cleavage by the activated programmable nuclease; wherein the detection region is configured to detect a signal produced by the released detection moiety and corresponding to a presence of the target nucleic acid; and wherein the presence or absence of the target nucleic acid is determined within a time of less than 30 minutes after the sample is received at the sample interface. 76. (Previously Presented) The device of claim 1, wherein the programmable nuclease, guide nucleic acid, or the reporter are immobilized to a device surface by a linkage, wherein the linkage comprises a covalent bond, a non-covalent bond, an electrostatic bond, a bond between streptavidin and biotin, an amide bond, or non-specific absorption.” The teachings of Gootenberg are documented above in the rejection of claim 1-5, 8, 10-12, 15-16 and 28-29 under 35 U.S.C. 103. Therefore, the invention as recited in claims 1 is prima facie obvious over the copending Application No. 18/058122 in view of Gootenberg . One of ordinary skill in the art would have had a reasonable expectation of success given the claims of copending application. It would have been obvious to provide a system for detecting any of a plurality of different target nucleic acids in a sample according to the limitations recited in claim 1 of the instant application based on claims 1 and 76 of copending Application No. 18/058122 in view of Gootenberg . This is a provisional nonstatutory double patenting rejection. Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 57 of copending Application No. 18/741443 in view of Gootenberg et al. (“ Gootenberg ”; Patent App. Pub. WO 2020186231 A2, Sept. 17, 2020) . Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is made obvious over the claims of copending Application No. 18/741443 . The claims of copending Application No. 18/741443 are drawn to: “ 1. (Previously Presented) A device for detecting a target nucleic acid, comprising: a. a sample interface configured to receive a sample comprising a target nucleic acid; b. a heating region in fluid communication with the sample interface and configured to amplify the sample received via the sample interface; c. a detection region in fluid communication with the heating region; d. a programmable nuclease probe disposed within the sample interface, the heating region, or the detection region, wherein the programmable nuclease probe comprises a programmable nuclease and a guide nucleic acid; and e. a reporter; wherein the programmable nuclease is activated by selective binding between the guide nucleic acid and the target nucleic acid within the heating region, the sample interface, or the detection region; wherein the reporter is configured to release a detection moiety upon cleavage by the activated programmable nuclease; wherein the detection region is configured to detect a signal produced by the released detection moiety and corresponding to a presence of the target nucleic acid; and wherein the presence or absence of the target nucleic acid is determined within a time of less than 30 minutes after the sample is received at the sample interface. 76. (Previously Presented) The device of claim 1, wherein the programmable nuclease, guide nucleic acid, or the reporter are immobilized to a device surface by a linkage, wherein the linkage comprises a covalent bond, a non-covalent bond, an electrostatic bond, a bond between streptavidin and biotin, an amide bond, or non-specific absorption.” The teachings of Gootenberg are documented above in the rejection of claim 1-5, 8, 10-12, 15-16 and 28-29 under 35 U.S.C. 103. Therefore, the invention as recited in claims 1 is prima facie obvious over the copending Application No. 18/741443 in view of Gootenberg . One of ordinary skill in the art would have had a reasonable expectation of success given the claims of copending application. It would have been obvious to provide a system for detecting any of a plurality of different target nucleic acids in a sample according to the limitations recited in claim 1 of the instant application based on claims 1 and 57 of copending Application No. 18/741443 in view of Gootenberg . This is a provisional nonstatutory double patenting rejection. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Abudayyeh et al. (“ Abudayyeh ”; Patent App. Pub. WO 2018170340 A1, Sept. 20, 2018) Claim 1 (Para. 21 and Para. 282). No c laims are in condition for allowance. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KENDRA R VANN-OJUEKAIYE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7529 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9:00 AM- 5:00 PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT Winston Shen can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-3157 . 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. /KENDRA R VANN-OJUEKAIYE/ Examiner, Art Unit 1682 /WU CHENG W SHEN/ Supervisory Patent Examiner, Art Unit 1682
Read full office action

Prosecution Timeline

Jun 13, 2023
Application Filed
Mar 27, 2026
Non-Final Rejection — §103, §DP (current)

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
0%
Grant Probability
0%
With Interview (+0.0%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 8 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month