CTNF 18/023,538 CTNF 81471 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 08-25 AIA Applicant's election with traverse of Group III in the reply filed on 12/17/2025 is acknowledged. The traversal is on the ground(s) that the applicant disagrees with Arizti Sanz . This is not found persuasive because the applicant did not provide any particular arguments towards the reference. Further in view of the art provided below . The requirement is still deemed proper and is therefore made FINAL. Claims 1-2,5-6,8,10,13,17-18,20,25-27,29,31,33,35-36,39-40,42,44,47-48,51,53-54,56-59,61,64,66,69,71,72,75-76,78 are pending. Claims 3-4,7,9,11-12,14-16,19,21-24,28,30,32,34,37-38,41,43,45-46,49-50,52,55,60,62-63,65,67-68,70,73-74,77,79-85 are cancelled. Claims 1-2,5-6,8,10,13,17-18,20,25-27,29,31,33,35-36,39-40,42,44,47-48,51,53-54,56-57 are withdrawn. An action on the merits for CLiams 58-59, 61,64,66,69,71,72,75-76,78 is set forth below. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 58-59, 61,64,66,69,71,72,75-76,78 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 58-59, 61,64,66,69,71,72,75-76,78 are indefinite over the phrase “wherein….without requiring extraction of virus polynucleotides from a sample”. The phrase is unclear as it appears to intend that viral polynucleotides are not extracted from a sample, however, this is unclear as step b requires releasing virus polynucleotides from viruses. As such it would be unclear how to have the structure of b that releasing polynucleotides from viruses and not “extract”. Therefore the metes and bounds are unclear. Further the claims are unclear as the structure of step b only requires the intending outcome of one or more of the intended uses, however, the wherein clause requires all the intended uses. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 58,59,61,69,72 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Gootenberg et al. (Science 2017 Vol 356 438-442) . With regard to claim 58, Gootenberg et al teaches the structures of droplet PCR with a CRISPR-Cas system (page 2). As such Gootenberg et al. teach a discrete volume comprising a CRISPR system with a protein and a guide RNA (p 2). Furthermore this droplet comprises solutions of PCR including solutions do preparing polynucleotides. The specification has not provided a specific formulation and as such would include any formulation that would be capable of inactivating nuclease. Gootenberg et al teaches viral samples (abstract). Gootenberg et al. teaches a temperature higher than 15 (Figure 2). With regard to claim 59, Gootenberg et al. teaches a device that has an RNA detection construct or DNA construct (p. 2 1st column). With regard to claim 61, Gootenberg et al. teaches the device comprises amplification reagents (p. 2 1st column). With regard to claim 69, Gootenberg et al. teaches the device comprises CAS13a (p. 2 1 st column). With regard to claim 72, Gootenberg et al. teaches that the device comprises a guide RNA with one or more synthetic mismatches (figure 3) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 64,66,75,76,78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gootenberg et al. (Science 2017 Vol 356 438-442) in view of Han et al. (Angew Chem Int Ed 2016 Vol 55 p. 8561-8565) . Gootenberg et al teaches the structures of droplet PCR with a CRISPR-Cas system (page 2). As such Gootenberg et al. teach a discrete volume comprising a CRISPR system with a protein and a guide RNA (p 2). Furthermore this droplet comprises solutions of PCR including solutions do preparing polynucleotides. The specification has not provided a specific formulation and as such would include any formulation that would be capable of inactivating nuclease. Gootenberg et al teaches viral samples (abstract). Gootenberg et al. teaches a temperature higher than 15 (Figure 2). Gootenberg et al. does not provide that the system comprises a substrate for CRISPR system. With regard to claim 64, Han et al. teaches the CRISPR systems can be placed on a substrate (microfluidic with polymers) (Figure 1 and p. 8561 2 nd column). With regard to claim 66, Han et al. teaches that this chip is considered a lab on a chip (p. 8565 last paragraph). With regards to claim 75-76, and 78 Han et al. teaches that the device includes lateral flows which would encompass reservoirs that can contain a reagent that comprises a first end to load the solution with CRISPR wherein that construct comprises DNA (p. 8561 2 nd paragraph Figure 1 ). Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the structure of Gootenberg et al. to place on a lab on a chip as taught by Han et al. The ordinary artisan would be motivated in order to rapidly screen gene functions (p. 8565). The ordinary artisan would have a reasonable expectation of success as Han eta l. teaches one can place CRISPR structures on a lab on a chip type construct . 07-21-aia AIA Claim (s) 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gootenberg et al. (Science 2017 Vol 356 438-442) in view of Blazej et al. (US Patent Application Publication 2018/0355404 December 13, 2018) . Gootenberg et al teaches the structures of droplet PCR with a CRISPR-Cas system (page 2). As such Gootenberg et al. teach a discrete volume comprising a CRISPR system with a protein and a guide RNA (p 2). Furthermore this droplet comprises solutions of PCR including solutions do preparing polynucleotides. The specification has not provided a specific formulation and as such would include any formulation that would be capable of inactivating nuclease. Gootenberg et al teaches viral samples (abstract). Gootenberg et al. teaches a temperature higher than 15 (Figure 2). Gootenberg et al. does not provide that the droplet PCR CRISPR CAS system comprises an affinity tag. With regard to claim 71, Blazej et al teaches that affinity tags can be used to attach to a substrate in droplet digital PCR assays (para 326). Therefore is would be prima facie obvious to one of ordinary skill at the time of the effective filing date to modify Gootenberg et al. to includes known structures of droplet digital PCR including tags that ca be used to capture the target of interest. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530. 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, Wu Cheng (Winston) Shen can be reached at 5712723157. 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. /KATHERINE D SALMON/ Primary Examiner, Art Unit 1682 Application/Control Number: 18/023,538 Page 2 Art Unit: 1682 Application/Control Number: 18/023,538 Page 3 Art Unit: 1682 Application/Control Number: 18/023,538 Page 4 Art Unit: 1682 Application/Control Number: 18/023,538 Page 5 Art Unit: 1682 Application/Control Number: 18/023,538 Page 6 Art Unit: 1682 Application/Control Number: 18/023,538 Page 7 Art Unit: 1682
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