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 Status
Currently, claims 1-10 are pending in the instant application. Claims 9-10 are withdrawn. This action is written in response to applicant' s correspondence submitted 9/10/2025. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is FINAL.
Claims 1-8 are under examination.
Withdrawn Objections and Rejections
The objection to claim 1 and 7 is withdrawn in view of the amendment to the claims.
The rejection of claims 1-8 under 35 USC 112(b) is withdrawn in view of the amendment to the claims.
The rejection of claims 1-7 under 35 USC 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Qi et al (WO 2018/226575) is withdrawn in view of the amendment to the claims.
The rejection of claims 1, 3-6 under 35 U.S.C. 102(a)(1) as being anticipated by Mekler (PNAS, 2017, vol 114, pp 5443-5448) is withdrawn in view of the amendment to the claims.
The rejection of claims 7-8 under 35 U.S.C. 103 as being unpatentable over Merkle (PNAS, 2017, vol 114, pp 5443-5448) in view of Ahern (The Scientist, 1995, 20, 22) is withdrawn in view of the amendment to the claims.
New Grounds of Rejections – Necessitated by Amendment to the Claims
Claim Objections
Claim 7 is objected to because of the following informalities: the claim recites i) a second container and Cas protein located in the second container…ii) a first container and the n kinds of guide RNA-reporter nucleic acid complex probes. The claim should recite the first container first then the second container. For example the claim should recite i) a first container…ii) a second container. Appropriate correction is required.
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.
Claims 1-7 are 35 U.S.C. 103 as being unpatentable over Church (WO2016/028843 A2) in view of GEN (Genetic Engineering and Biotechnology News, Aug 2018, pp. 1-7).
Church teaches a RNA-guided system for detecting target nucleic acid. Church teaches the DNA binding protein-guide RNA complex may be used to for a detectable complex to detect the presence of target DNA. Church teaches the complex comprises the presence of a detectable label and the detectable label is present on the guide RNA (see pg. 2 lines 12-22). Church teaches a plurality of target nucleic acid sequences with a plurality of corresponding guide RNA sequences (see pg. 3, lines 9-11). Church teaches a 3’ tail portion of a guide RNA may be complementary to a probe sequence (see pg. 3, lines 12-15). Church teaches the 3’ tail portion may be complementary or other bind to one or more multiple probe sequences (see pg. 3 line 18-20). Church teaches a guide RNA, tetraloop, with a barcode and labeled probe, including more than one label (see figure 4A and 4B). Church teaches the probe sequence includes a detectable label and the probe sequence is bound to the 3’ tail sequence (see pg. 3, lines 24-26). Church teaches a multiplex method comprising guide RNA/Cas9 protein complexes (n>2) (see pg. 5, line 20-21, pg 6, line 32-36 cont’d to pg 7, line 1-2). Church teaches detectable labels include FRET fluorophores (donor/acceptor pairs) (see pg. 16, lines 3-8). Church teaches probes with multiple gRNA/Cas9 complexes which are differentially labeled (See pg. 18, lines 16-18) (claim 4). Church teaches a single barcode RNA on 3’ tail (single stranded RNA) (see ex 1) (claim 5). Church teaches a kit comprising an ensemble of all Cas9-gRNA complexes (see pg. 47, lines 1-7) (claim 7). Church does not teach using a Cas12 protein.
However, other CRISPR enzymes were known in the art. GEN teaches Cas12a, another CRISPR enzyme is more effective and precise. GEN teaches Cas12a is more specific and Cas12a is better than Cas9 (see last paragraph).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to replace Cas9 as taught by Church with a more effective and precise Cas protein, Cas12A, as taught by GEN in the Cas-gRNA complex of Church for the expected benefit of a more effective and precise Cas functioning protein, as known in the art.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Church (WO2016/028843 A2) in view of GEN (Genetic Engineering and Biotechnology News, Aug 2018, pp. 1-7) and further in view of Ahern (The Scientist, 1995, 20, 22)
Church in view of GEN is set forth above. While Church teaches amplification using polymerases and dNTPs, Church in view of GEN does not teach a kit comprising container for a polymerase or a sixth container for dNTPs.
However Ahern teaches aspects of kits of reagents. Ahern teaches that a kit supplies all of the necessary reagents for a particular application and provides detailed instructions to follow (see pg. 20 – the kit concept). Ahern et al. teaches that packaging reagents in kit format is convenient, offering the scientist the opportunity to better manage their time. Ahern et al. teach that premade reagents and packaged kits saves researchers time (see page 4 and 5).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have combined Cas12, gRNA and detectable probe complex of Church in view of GEN and include polymerase and dNTPs into containers in a kit as taught by Ahern et al. Additionally it would have bene prima facie obvious to include additional containers with reagents, including dNTPs, polymerase and buffers in separate containers in a kit as taught by Ahern. One would have been motivated to do so based on the assertion of Ahern that kits of reagents are convenient and save time (see pg. 20).
Conclusion
No claims are allowable.
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 SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
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