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 .
Response to Amendment
The amendment filed 12/19/2025 is acknowledged. Claims 1, 9, 10, 14, 15, 21, 24, 25, 27-29, 31-33 and 62-67 are pending (claims 62-67 being newly added). Applicant amended claim 1 to require “a CRISPR RNA-guided Cas-transposase system” (previously, one of the options listed in the claim), thereby switching from the elected species of “collateral cleavage” to the non-elected species of “transposition” as the mechanism.
Therefore, regarding the Office action mailed 09/24/2025, the rejection under 35 USC 102 over Chen is withdrawn. In addition, the rejection of claims 24 and 27 under 35 USC 112(b) is withdrawn in view of the amendment to claim 24. New grounds of rejection are 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 65-67 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. These claims depend from claim 16, which has been cancelled. For purposes of examination over the prior art, these claims will be considered as depending from claim 64.
Claim Rejections - 35 USC § 102
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) 1, 21, 24 and 62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chittoor (US 2019/0093090).
Regarding claim 1, Chittoor disclosed:
a reporter nucleic acid comprising a tag
Figure 12, Oligo Streptavidin Donor and paragraph [0030]: “…an oligo with an Alpha Streptavidin donor bead attached.” Here, the donor bead can be considered a “tag”. See also paragraph [0209].
a guide RNA that comprises a nucleic acid sequence complementary to a gRNA target nucleic acid sequence
Figure 12, Putative gRNA and paragraph [0030]: “The putative guide RNAs (gRNA) are made using in vitro transcription. These guide RNA sequences are linked to the flank sequences (Flank1: SEQ ID NO: 3380; Flank2: SEQ ID NO: 3381) via the linker sequence (SEQ ID NO: 3382).” Note that the claim does not specify any particular gRNA target nucleic acid sequence, and since any single-stranded RNA is inherently complementary to its complement sequence, the gRNA in Figure 12 would be complementary to a particular “target” sequence. See also paragraph [0209].
a CRISPR RNA-guided Cas-transposase system
Figure 12, 6-His_tag RGEN and paragraph [0030]: “A CRISPR-associated transposase is expressed in E. coli with a His-tag. This His-tag (represented in the figure as 6-His_tag) serves as the binding site for the Alpha acceptor bead.” See also paragraph [0209].
Regarding claim 21, either of the reporter nucleic acid or the guide RNA can be considered as being conjugated to a microparticle, i.e. the “Donor” bead (the reporter nucleic acid via streptavidin, the guide RNA via hybridization of “Flank 2” to the reporter nucleic acid, which is attached to the microparticle via streptavidin). See Figure 12.
Regarding claim 24, “Flank 2” can be considered an “indicator nucleic acid” (see Figure 12).
Regarding claim 62, see Figure 12. 6-His_tag RGEN is a CRISPER-associated transposase, and therefore qualifies as both a “Cas protein” and a “transposase protein”.
Claim(s) 1, 9, 10, 14 and 62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chittoor (US 2019/0093090). This rejection is based upon a different application of the same reference as the rejection above.
Regarding claim 1, Chittoor disclosed:
a reporter nucleic acid comprising a tag
See paragraph [0195] and Figure 7. The LacZ reporter gene is a “reporter nucleic acid comprising a tag”. The instant specification indicates that a “tag” can be an “affinity tag” (paragraph [0006]). Therefore, any segment of the LacZ gene can be an “affinity tag” comprised by the reporter nucleic acid, since a complementary nucleic acid could be made to such segment, which would bind thereto.
a guide RNA that comprises a nucleic acid sequence complementary to a gRNA target nucleic acid sequence
See paragraph [0195] (emphasis provided) and Figure 7. “The ROI expression plasmid and the LacZ reporter plasmid were co-transformed into E. coli. Upon expression of the ROI elements (CRISPR-associated transposase and associated guide-RNA)…”.
a CRISPR RNA-guided Cas-transposase system
See paragraph [0195] (emphasis provided) and Figure 7. “The ROI expression plasmid and the LacZ reporter plasmid were co-transformed into E. coli. Upon expression of the ROI elements (CRISPR-associated transposase and associated guide-RNA)…”.
Regarding claims 9 and 10, the same plasmid comprising LacZ (the reporter nucleic acid) also comprises “target sequence” (see paragraph [0025] and Figure 7). The plasmid is a double-stranded nucleic acid.
Regarding claim 14, these plasmids are introduced into E. coli, which is a bacterium. As such, E. coli represents a “biological sample”.
Regarding claim 62, the system includes a “CRISPR-associated transposase” (paragraph [0195]), which can be considered a “Cas protein” or a “transposase protein”.
Conclusion
Claims 15,25,27-29,31-33 and 63-64 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681