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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant’s response filed February 13, 2026 has been received and entered into the application file. All arguments have been fully considered.
Claims 1 and 4-35 are pending. Claims 2-3 are cancelled. Claims 8, 12, 14, 16-19, and 21-35 are withdrawn. Claims 1 and 15 are amended. Claims 1, 4-7, 9-11, 13, 15 and 20 are being examined on the merits herein.
Objection(s)/Rejection(s) Withdrawn
Drawings
Re: The drawings are objected to for the following informalities:
Examiner notes many of the figures contain writing that is difficult to read/decipher. Examiner suggests trying a different font or sizing the drawings in a different manner. Examiner additionally notes Fig 36A is especially difficult to decipher.
Applicant submitted new drawings 2/13/2026 with improved clarity. As such, the previously filed objection is withdrawn.
Double Patenting
RE: Claims 1 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 29, and 37 of copending Application No.17/928,355 (reference application) in view of Qi (WO 2019/051278 A1, published March 14, 2019; IDS filed 8/16/2022). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 29, and 37 of the reference application make obvious claims 1, 3, and 5 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s remarks have been considered and have been found persuasive in regards to the differences between the Tn transposase system and the Mu transposase system. As such, the previously filed rejections are withdrawn.
RE: It’s additionally noted claim 1 of the instant application is further rejected over reference application 19/043,619 claim 1. The only difference between the instant application and the reference application is the reference application claim 1 claims the Tn7 transposase. However, as set forth above, it would be obvious to substitute one known transposase for another. Examiner additionally notes the reference application claim 1 also claims Type I-B Cas proteins. As the instant application claims Type I Cas protein, Type I-B is thus included in the limitations of the instant claim 1.
Applicant’s remarks have been considered and have been found persuasive in regards to the differences between the Tn transposase system and the Mu transposase system. As such, the previously filed rejections are withdrawn.
RE: It’s additionally noted claim 1 of the instant application is further rejected over reference application 18/269,813 claim 1. The only difference between the instant application and the reference application is the reference application claim 1 claims the Tn7 transposase. However, as set forth above, it would be obvious to substitute one known transposase for another. Examiner additionally notes the reference application claim 1 also claims Type I-B Cas proteins. As the instant application claims Type I Cas protein, Type I-B is thus included in the limitations of the instant claim 1.
Applicant’s remarks have been considered and have been found persuasive in regards to the differences between the Tn transposase system and the Mu transposase system. As such, the previously filed rejections are withdrawn.
RE: It’s additionally noted claim 1 of the instant application is further rejected over reference application 18/248,252 claim 1. The only difference between the instant application and the reference application is the reference application claim 1 claims the Tn7 transposase. However, as set forth above, it would be obvious to substitute one known transposase for another. Examiner additionally notes the reference application claim 1 also claims Type I-F Cas proteins. As the instant application claims Type I Cas protein, Type I-F is thus included in the limitations of the instant claim 1.
Applicant’s remarks have been considered and have been found persuasive in regards to the differences between the Tn transposase system and the Mu transposase system. As such, the previously filed rejections are withdrawn.
RE: It’s additionally noted claim 1 of the instant application is further rejected over reference application 17/773,104 claim 1. The only difference between the instant application and the reference application is the reference application claim 1 claims the Tn7 transposase. However, as set forth above, it would be obvious to substitute one known transposase for another. Examiner additionally notes the reference application claim 1 also claims Type I-B Cas proteins. As the instant application claims Type I Cas protein, Type I-B is thus included in the limitations of the instant claim 1.
Applicant’s remarks have been considered and have been found persuasive in regards to the differences between the Tn transposase system and the Mu transposase system. As such, the previously filed rejections are withdrawn.
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.
RE: Claims 1, 4-7, 9-11, 13, 15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qi (WO 2019/051278 A1, published March 14, 2019; IDS filed 8/16/2022), as evidenced by Harshey (Harshey, R.M., Microbiol Spectr (2014) 2(5): 1- 36; PTO 892).
Applicants amended claims 1 and 15 to require MuA, MuB, and MuC thus overcoming the prior art. As such, the previously filed rejections are withdrawn.
New Ground(s) of Rejection/Objection
Claim Objections
Claims 1 and 15 are objected to for the following informalities:
In regards to claim 1, Examiner notes said claim states:
An engineered system for inserting a donor polynucleotide into a target polynucleotide, the system comprising:
a. one or more CRISPR-associated Mu transposases, wherein the one or more CRISPR- associated Mu transposases comprise a MuA, a MuB, a MuC;
b. one or more Cas proteins, wherein the one or more Cas proteins comprise one or more Type I Cas proteins; and
c. a guide molecule that can form a complex with the Cas protein and direct sequence- specific binding of the guide-Cas protein complex to the target polynucleotide.
In regards to claim 15, Examiner notes said claim states:
An engineered system for insertion of a donor polynucleotide into a target polynucleotide, the system comprising one or more polynucleotides encoding:
a. one or more CRISPR-associated Mu transposases, wherein the one or more CRISPR- associated Mu transposases comprise a MuA, a MuB, a MuC;
b. one or more Cas proteins, wherein the one or more Cas proteins comprise one or more Type I Cas proteins; and
c. a guide molecule that can form a complex with the Cas protein and direct sequence- specific binding of the guide-Cas protein complex to the target polynucleotide.
Applicant remarks (p8) state: Applicant has amended claims 1 and 15 to require “wherein the one or more CRISPR-associated Mu transposases comprise MuA, MuB, and MuC,” expressly claiming all three Mu transposase components functioning together”. Thus, Examiner believes claims 1 and 15 should state:
In regards to claim 1:
An engineered system for inserting a donor polynucleotide into a target polynucleotide, the system comprising:
a. and a MuC;
b. one or more Cas proteins, wherein the one or more Cas proteins comprise one or more Type I Cas proteins; and
c. a guide molecule that can form a complex with the Cas protein and direct sequence- specific binding of the guide-Cas protein complex to the target polynucleotide.
In regards to claim 15, Examiner notes said claim states:
An engineered system for insertion of a donor polynucleotide into a target polynucleotide, the system comprising one or more polynucleotides encoding:
a. and a MuC;
b. one or more Cas proteins, wherein the one or more Cas proteins comprise one or more Type I Cas proteins; and
c. a guide molecule that can form a complex with the Cas protein and direct sequence- specific binding of the guide-Cas protein complex to the target polynucleotide.
Appropriate correction is required.
Claim 4 is objected to for the following informalities:
In regards to claim 4, Examiner notes said claim depends from cancelled claim 3. For the sake of compact prosecution, Examiner is interpreting claim 4 as if it depends from claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-7, 9-11, 13, 15 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter.
The rationale set forth below conforms to current Office practice for examination of claims under § 101.
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All of the claims are directed to a statutory category, e.g., a composition (Step 1: YES).
Claims 1 and 15: Claim 1 and 15 are directed to a biological composition comprising:
a. CRISPR-associated Mu transposases, wherein the CRISPR-associated Mu transposases comprise a MuA, a MuB, and a MuC;
b. one or more Cas proteins, wherein the one or more Cas proteins comprise one or more Type I Cas proteins; and
c. a guide molecule that can form a complex with the Cas protein and direct sequence- specific binding of the guide-Cas protein complex to the target polynucleotide.
Makarova (Makarova et al., Nat Microbiol. (2025) 10(12): 3346-336; PTO 892) teaches of naturally occurring Mu transposon-associated type I CRISPR-Cas (Fig 2D). As seen in Fig 2D, the I-A2 transposon-associated system comprises CRISPR-associated MuA, MuB, and MuC and one or more Type I Cas proteins.
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Makarova additionally teaches a trend in CRISPR-Cas evolution is the recruitment of CRISPR-Cas systems by large transposons, enabling RNA-guided transposition (p3349, 2nd column last paragraph – top of p3350). As a POSITA will appreciate, this reads on a guide molecule forming a complex with the CRISPR-Cas protein and directing sequence-specific binding of the guide-Cas protein complex to the target polynucleotide. Thus, the claim recites a combination of natural products.
Therefore, the claim as a whole, considering all claim elements both individually and in combination, do no amount to significantly more than the natural Mu transposon-associated type I CRISPR-Cas system. Thus, the claimed composition does not have markedly different characteristic from what occurs in nature and is a "product of nature" exception. Accordingly, the claims are directed to an exception (Step 2A, prong one: YES). Thus, the claims do not qualify as eligible subject matter and are rejected under 35 U.S.C. 101.
In regards to claims 4-7, 9-11, 13, 15, and 20, said claims further define the composition as having specific Cas proteins, donor and target polynucleotides, and as comprising a vector, which are all products of nature. These limitations do not limit the claimed composition in such a way that is markedly different from their natural counterparts.
Thus, the claimed composition does not have markedly different characteristics from what occurs in nature and is a "product of nature" exception. Thus, the claims do not qualify as eligible subject matter and are rejected under 35 U.S.C. 101.
Accordingly, the claims as a whole are directed to an exception (Step 2A, prong one: YES). Thus, the claims do not qualify as eligible subject matter and are rejected under 35 U.S.C. 101.
The next part of the analysis involves whether the claimed invention recites additional elements that integrate the judicial exception into a practical application (Step 2A, prong two).
Given the claims are directed to a composition, the claims do not recite additional steps that integrate the judicial exception into a practical application (Step 2A, prong two: No).
The final part of the analysis involves whether the claimed invention, as a whole, recite something “significantly more” than the judicial exceptions (Step 2B).
In view of the above and considered as a whole, the claimed composition does not have markedly different characteristics from what occurs in nature and such elements discussed above are not significantly more than the indicated judicial exceptions. Thus, the claims do not qualify as eligible subject matter and are rejected under 35 U.S.C. 101 (Step 2B: NO).
Conclusion
After a thorough search, Examiner acknowledges there is no prior art anticipating or making obvious the instant invention as claimed in claim 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE R SMALL whose telephone number is (703)756-4783. The examiner can normally be reached Monday - Friday 8:30am-4pm.
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/KATHERINE R SMALL/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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