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 .
This action is in response to papers filed on 4/27/2026.
Claims 45-58, 61-69 are pending. Claims 59-60 have been cancelled.
The following rejections are newly applied necessitated by amendment.
This action is FINAL.
Withdrawn Rejection
The 35 USC 112 b, 35 USC 102, and 35 USC 103 rejections made in the previous office action is withdrawn based upon amendments to the claims.
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.
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) 45-51, 53-54, 56-57, 65-69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steens et al. (WO2020/256553 December 24, 2020 listed on IDS as Wageningen) in view of Faure et al. (J Mol Biol 2019 Vol 431 3-20)
With regard to claim 45, Steens et al. teaches a system comprising a Cas10 (p 1 lines 10-12 and p 44 lines 10-15). Steens et al. teaches a molecule binding to a target (p 44 lines 8-10). Steens et al. teaches a nuclease and reporter system (p 2 lines 19-21, p 12 lines 19-21). However Steens et al. does not teach the nuclease comprises NucC and does not have a CARF domain.
With regard to claim 46, Steens et al. teaches viral RNA (p. 22 lines 19-20).
With regard to claim 47, Steens et al. teaches ATP (p 9 lines 32).
With regard to claim 48, Steens et al teaches that the molecule is capable of binding the target which comprises a nucleic acid complementary to a target (p. 9 lines 10-13).
With regard to claim 49, Steens et al. teaches that the molecule comprises a guide RNA (p 22 lines 10-25).
With regard to claim 50, Steens et al. teaches multiple guide RNA (p. 26 lines 30-35).
With regard to claim 51, Steens et al. teaches a type III CRISPR complex (p. 26 lines 30-33).
With regard to claims 53-54, Steens et al. teaches Cmr1, Cmr4, Cmr 1-6 (p. 17 lines 8-10).
With regard to claim 56, Steens et al. teaches a reporter system with nucleic acid (p. 12 lines 20-30).
With regard to claim 57, Steens et al. teaches a dsDNA and a detectable label (p. 12 lines 20-30).
With regard to claim 65, Steens teaches a method of detecting a target using the system of 45 with a signal reporter systems (p. 1, 44, 2, 9).
With regard to claim 66, Steens et al. teaches a method of viral RNA (p. 22 lines 19-20).
With regard to claim 67, Steens et al. teaches a method of detection of SARS-CoV-2 (p. 23 lines 15-16).
With regard to claim 68, Steens et al. taches a nucleic acid encoding a Cas10 protein (p. 1 lines 10-12 and p 44 lines 10-15).
With regard to claims 69, Steens et al. teaches nucleic acid comprising Cmr1, Cmr4, Cmr 1-6 (p. 17 lines 8-10).
With regard to claim 45, Faure et al. teaches that CRSIPR CAS systems can be complete in all other respects and functionally lack CARF domain proteins (p. last full paragraph). Faure et al. teaches that CARF lacking does not alter the system functionality.
Therefore it would be prima facie obvious to one of ordinary skill at the time of the effective filing date to use any of the finite number of CRISPR CAS systems including ones without CARF domain with a reasonable expectation of the system having functionality.
Response to Arguments
The response traverses the rejection. A summary of the arguments is provided below with response to arguetmsn following. The reply assert that there is unexpectedly found that the combination of CAS10 and a nuclease comprising NucC significantly enhanced detection sensitivity (p. 9). This argument has been reviewed but has not been found persuasive. It is noted that the claimed product is not the same structures as one recited on page 43 and as such it is not clear if the asserted unexpected success would be based upon the claimed structure.
Claim(s) 52,55,63-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steens et al. (WO2020/256553 December 24, 2020 listed on IDS as Wageningen) and Faure et al. (J Mol Biol 2019 Vol 431 3-20) as applied to Claim(s) 45-51, 53-54, 56-57, 65-69 in view of McDonald (BMC Genomics 2019 cited on IDS).
With regard to claim 52 and 63, Steens et al. teaches a system comprising a Cas10 (p 1 lines 10-12 and p 44 lines 10-15). Steens et al. teaches a molecule binding to a target (p 44 lines 8-10). Steens et al. teaches a nuclease and reporter system (p 2 lines 19-21, p 12 lines 19-21). Steens et al. teaches viral RNA (p. 22 lines 19-20). Steens et al. teaches ATP (p 9 lines 32). Steens et al teaches that the molecule is capable of binding the target which comprises a nucleic acid complementary to a target (p. 9 lines 10-13). Steens et al. teaches that the molecule comprises a guide RNA (p 22 lines 10-25).Steens et al. teaches multiple guide RNA (p. 26 lines 30-35). Steens et al. teaches a type III CRISPR complex (p. 26 lines 30-33). Steens et al. teaches Cmr1, Cmr4, Cmr 1-6 (p. 17 lines 8-10).
With regard to claim 64, Steens et al. teaches that the molecule comprises a guide RNA (p 22 lines 10-25).
Steen et al. teaches systems to detect Vibrio cholerae (p. 24 lines 12-15), however Steen and Faure et al does not teach Vibrio metoecus.
With regard to claim 52 and 63, McDonald teaches that that CRISPR CAS10 is identified in V. metoecus strains (p. 3 1st paragraph, and p 9 last parpaghra).
With regard to claim 55, McDonald et al. teaches the system comprises Cas6 (p 10 2nd column 1st full paragraph).
Therefore it would be prima facie to one of ordinary skill at the time of the effective filing date to modify the design of Steens et al. and Faure et al to use other known systems of CRISPR including those that encompass Cas10 from V. metoecus as taught by McDonald. The ordinary artisan would have a reasonable expectation of success as McDonald et al. teaches that these regions are within V. metoecus and Steens et al. and Faure et al designs systems of other Vibrio species.
Claim(s) 58-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steens et al. (WO2020/256553 December 24, 2020 listed on IDS as Wageningen) and Faure et al. (J Mol Biol 2019 Vol 431 3-20) and McDonald (BMC Genomics 2019 cited on IDS) as applied to claims 52,55,63-64 in view of Lau et al. (Mol Cell 2929 cited on IDS).
Steens et al. teaches a system comprising a Cas10 (p 1 lines 10-12 and p 44 lines 10-15). Steens et al. teaches a molecule binding to a target (p 44 lines 8-10). Steens et al. teaches a nuclease and reporter system (p 2 lines 19-21, p 12 lines 19-21). Steens et al. teaches viral RNA (p. 22 lines 19-20). Steens et al. teaches ATP (p 9 lines 32). Steens et al teaches that the molecule is capable of binding the target which comprises a nucleic acid complementary to a target (p. 9 lines 10-13). Steens et al. teaches that the molecule comprises a guide RNA (p 22 lines 10-25).Steens et al. teaches multiple guide RNA (p. 26 lines 30-35). Steens et al. teaches a type III CRISPR complex (p. 26 lines 30-33). Steens et al. teaches Cmr1, Cmr4, Cmr 1-6 (p. 17 lines 8-10). McDonald teaches that that CRISPR CAS10 is identified in V. metoecus strains (p. 3 1st paragraph, and p 9 last parpaghra).
However, Steens Faure et al. and McDonald do not teaches the use of the recited nuclease.
With regard to claim 58, Lau et al. teaches the use of nuclease activated with cA3 of V. metoecus (p 2 and 8).
With regard to claim 59, Lau et al. teaches NucC nuclease which does not have a CARF domain (p 8 1st parpaghra).
With regard to claim 60-61, Lua et al teaches NucC from V. metoecus (p. 8 1st parpaghra).
With regard to claim 62, this sequence would be encompassed by the structure of Lua et al. as it is the NucC structure (p. 8 1st parpaghra).
Therefore it would be prima facie to one of ordinary skill at the time of the effective filing date to modify the design of Steens et al. Faure et al. and McDonald to use the NucC region of V. metoecus as taught by Lua et al. The ordinary asserts would be motivated to use this region as it is a common mechanism of action and can be activated by many type III (p. 10 1st parpaghra). As such the ordinary artisan would be motivated to region a known regio that works in CRISP systems.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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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.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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