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 .
Claims 1-24 are pending in the application.
Drawings
The drawing Figure 8E is not of sufficient quality to permit examination. The letters in the box is illegible. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
Specification
The disclosure is objected to because of the following informalities: the specification mentions 6 times that specific examples are given in the Tables (page 36-42). However, there is no table in the specification. The specification also states CASTs are found in Appendix 1, but there is no Appendix 1.
The description of drawing Figure 8A-F does not match the drawing. Drawing 8C does not have X and Y axis. 8D is not a box plots. Figure E and F are not described.
Appropriate correction is required.
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 5-10 and 16-23 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.
Regarding claims 5-10 and 16-23, the word “represented” renders the claim indefinite because it is unclear what this representation encompasses. It is unclear whether it means the claimed CAST comprises a sequence having 90% and above to the SEQ ID NO: 1-6, or having structure and/or function same as those CAST encoded by claimed sequences.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a1)(a2) as being anticipated by Sternberg (US 2020/0283769, IDS).
Claim 1 is drawn to a non-naturally occurring system for RNA guided DNA integration comprising an isolated I-F CAST, comprising: a) TnsA-TnsB-TnsC; and b) TniQ-Cas8-Cas5-Cas7-Cas6; wherein TniQ-Cas8-Cas5 are fused. Claim 12 is drawn to the same system without specifying any fusion.
Sternberg teaches RNA guided DNA integration using TN7 like transposons (abstract). Sternberg teaches a system comprises a CRISPR-Cas system comprising a) Cas5, Cas6, Cas7 and Cas8 and b) an engineered Tn7 like transposon system comprising TnsA, TnsB TnsC and TniQ (claim 1). Sternberg teaches Cas8 and Cas5 forms a Cas8-Cas5 fusion (claim 4). Sternberg teaches the TniQ-Cas8/Cas5 fusion protein (paragraph [0129], Figure 24D). Therefore, the disclosure from Sternberg anticipates instant claim 1 and 12.
Regarding claims 2, 3, 13 and 14, it recites that a) and b) may be either sequential or non-sequential. As such, the system taught by Sternberg anticipates the claimed invention.
Regarding claim 4 and 15, Sternberg teaches the system further comprises a gRNA specific for a target site (claim 6), which meets the limitation crRNA.
Regarding claim 11 and 24, Sternberg teaches the system further comprises donor DNA to be integrated that comprises a cargo nucleic acid (paragraph [0009]).
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) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg, in view of sequence Q87GC1_VIBPA (see attached alignment).
The sequence Q87GC1-VIBPA is known as TnsA in prior art, which has 100% sequence homology with SEQ ID NO: 6.
It would have been obvious to an ordinary skilled in the art to use a prior art known TnsA sequence in the system taught by Sternberg. The ordinary skilled in the art would have reasonable expectation of success to make such system because all components were known in the prior art. Therefore, the claimed invention of claims 5 and 16 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg, in view of sequence A0A0L8U8M1_VIBPH (see attached alignment).
The sequence A0A0L8U8M1_VIBPH is known as transposase from Vibrio parahaemolyticus in prior art, which has 100% sequence homology with SEQ ID NO: 5.
It would have been obvious to an ordinary skilled in the art to use a prior art known transposase sequence in the system taught by Sternberg. The ordinary skilled in the art would have reasonable expectation of success to make such system because all components were known in the prior art. Therefore, the claimed invention of claims 6 and 17 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 7 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg, in view of the sequence A0A0M2II81_VIBPH (see alignment).
The sequence A0A0M2II81_VIBPH is known as transposase from Vibrio parahaemolyticus in prior art, which has 100% sequence homology with SEQ ID NO: 4.
It would have been obvious to an ordinary skilled in the art to use a prior art known transposase sequence in the system taught by Sternberg. The ordinary skilled in the art would have reasonable expectation of success to make such system because all components were known in the prior art. Therefore, the claimed invention of claims 7 and 18 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg, in view of the sequence A0A0L8U959_VIBPH (see alignment).
The sequence A0A0L8U959_VIBPH is known as CRISPR associated protein from Vibrio parahaemolyticus in prior art, which has 100% sequence homology with SEQ ID NO: 2.
It would have been obvious to an ordinary skilled in the art to use a prior art known CRISPR associated protein sequence in the system taught by Sternberg. The ordinary skilled in the art would have reasonable expectation of success to make such system because all components were known in the prior art. Therefore, the claimed invention of claims 9 and 19 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg, in view of the sequence Q87GC7_VIBPA (see alignment).
The sequence Q87GC7_VIBPA is known as CRISPR associated protein Csy4 family from Vibrio parahaemolyticus in prior art, which has 100% sequence homology with SEQ ID NO: 3.
It would have been obvious to an ordinary skilled in the art to use a prior art known CRISPR associated protein sequence in the system taught by Sternberg. The ordinary skilled in the art would have reasonable expectation of success to make such system because all components were known in the prior art. Therefore, the claimed invention of claims 10 and 20 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg, in view of the sequence A0A0L8U959_VIBPH (see alignment).
The sequence A0A0L8U959_VIBPH is known as CRISPR associated protein from Vibrio parahaemolyticus in prior art, which has 100% sequence homology with SEQ ID NO: 2.
It would have been obvious to an ordinary skilled in the art to use a prior art known CRISPR associated protein sequence in the system taught by Sternberg. The ordinary skilled in the art would have reasonable expectation of success to make such system because all components were known in the prior art. Therefore, the claimed invention of claims 9 and 19 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg, in view of the sequence A0A227JDH_VIBPH (see alignment).
The sequence A0A227JDH_VIBPH is known as CRISPR associated protein Csy2 from Vibrio parahaemolyticus in prior art, which has 100% sequence homology with SEQ ID NO: 7.
It would have been obvious to an ordinary skilled in the art to use a prior art known CRISPR associated protein sequence in the system taught by Sternberg. The ordinary skilled in the art would have reasonable expectation of success to make such system because all components were known in the prior art. Therefore, the claimed invention of claims 21 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg, in view of the sequence Q87GC9_VIBPA (see alignment).
The sequence Q87GC9_VIBPA is known as CRISPR associated protein from Vibrio parahaemolyticus Csy2 in prior art, which has 91.9% sequence homology with SEQ ID NO: 8.
It would have been obvious to an ordinary skilled in the art to use a prior art known CRISPR associated protein sequence in the system taught by Sternberg. The ordinary skilled in the art would have reasonable expectation of success to make such system because all components were known in the prior art. Therefore, the claimed invention of claim 22 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg, in view of the sequence A0A227JCA2_VIBPH (see alignment).
The sequence A0A227JCA2_VIBPH is known as TniQ domain containing protein from Vibrio parahaemolyticus in prior art, which has 100% sequence homology with SEQ ID NO: 9.
It would have been obvious to an ordinary skilled in the art to use a prior art known TniQ sequence in the system taught by Sternberg. The ordinary skilled in the art would have reasonable expectation of success to make such system because all components were known in the prior art. Therefore, the claimed invention of claim 23 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637
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