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 .
An action on the merits for claims 45-69 is set forth below.
Claim Rejections - 35 USC § 112
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.
Claims 54, 62-64, 68-69 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.
Claim 54 is indefinite over “for example two, three or more”. Regarding claim52, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Further the claims has a list with “and/or” statements making it unclear which groupings are required by the claim.
Claim 62 requires “SEQ ID NO. 3” but there provides a sequence with an accession number. It is not clear if the claim only requires “SEQ ID NO. 3” or requires all the descriptive information provided by the accession number.
63-64 are indefinite over the listing with “and/or” in claim 63. The claims have a list with “and/or” statements making it unclear which groupings are required by the claim.
Claims 68-69 are indefinite over the listing with “and/or” in claim 68. The claims have a list with “and/or” statements making it unclear which groupings are required by the claim. Further, Regarding claim 68, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 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 –
(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.
Claim(s) 45-51,53-54,56-57,65-69 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steens et al. (WO2020/256553 December 24, 2020 listed on IDS as Wageningen).
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).
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).
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) 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) 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 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. 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 a. 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 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 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. 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.
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