DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-12, 19, and 25 in the reply filed on 5/29/2026 is acknowledged.
The election of the following species is acknowledged: amino acid position 713 in claim 1; V713M in claim 3; positions 713, 628, and 683 in claim 4; V713M, I628M, and T683K in claim 6; and SEQ ID NO: 4 in claims 9 and 10.
Claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/29/2026.
In light of the prior art search, the species election has been expanded to include positions 515, 529, 531, 558, 559, 562, 567, 568, 575, 630, 704, 718, 743, 780, 782, 788, and 872; substitutions E515K, N529R, D559K, D559R, D559S, D718K, N780K, N782R, and E788R; and SEQ ID NO: 5.
Priority
This application is a CON of PCT/US2022/079074 (11/1/2022) which claims benefit of 63/263,440 (11/2/2021).
Information Disclosure Statement
The information disclosure statement (IDS) filed on 7/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(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.
Claims 1-8 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazur et al., US 2017/0096648 A1.
Regarding claims 1 and 2, Mazur teaches a DNA polymerase with an amino acid sequence according to SEQ ID NO: 16, which is 100% identical to instant SEQ ID NO: 1 (see sequence alignment in OA appendix; Mazur p. 28 para. 195; Table 2). The position numbers of SEQ ID NO: 16 correspond to the position numbers of instant SEQ ID NO: 2 (see sequence alignment in OA appendix). Mazur teaches that the polymerase with a sequence according to SEQ ID NO: 16 has a substitution at position 713, numbered relative to SEQ ID NO: 16 or instant SEQ ID NO: 2 (Mazur pp. 28-29 para. 195).
Regarding claim 3, Mazur teaches that the substitution is V713M (Mazur p. 29 para. 195).
Regarding claims 4 and 5, Mazur teaches a sequence according to SEQ ID NO: 16 with a substitution at one or more of residues 515, 529, 531, 558, 559, 562, 567, 568, 575, 630, 704, 713, 718, 743, 780, 782, 788, and 872, numbered relative to SEQ ID NO: 16 or instant SEQ ID NO: 2 (Mazur pp. 28-29 para. 195; Table 2).
Regarding claim 6, Mazur teaches that the mutations include E515K, N529R, D559K, D559R, D559S, V713M, D718K, N780K, N782R, and E788R (Mazur pp. 29 para. 195; Table 2).
Regarding claim 7, Mazur teaches that the polymerase has an amino acid sequence that is 99.7% identical to SEQ ID NO: 2 (see sequence alignment in OA appendix).
Regarding claim 8, Mazur teaches that the polymerase has a DNA-binding domain (Mazur p. 21 para. 131-132).
Regarding claim 25, Mazur teaches that the polymerase has a mutation at amino acid position 718 (Mazur pp. 28-29 para. 195).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Mazur as applied to claims 1-8 and 25 above, in view of Wu et al., Scientific Reports. 2017 Jul 6;7(1):4756; as evidenced by Gao et al., Nature structural biology. 1998 Sep;5(9):782-6 and UniProt accession P39476.
Mazur teaches a polymerase according to claim 1, comprising a DNA binding domain, as set forth above. Mazur does not teach that the DNA binding domain comprises a sequence of SEQ ID NO: 5 or a sequence at least 95% identical to SEQ ID NO: 5 (claims 9 and 10) or that the DNA binding domain is attached to the N-terminus of the polymerase (claim 11) through an amino acid linker (claim 12).
Regarding claim 9, Wu teaches that for engineering of microorganisms, there is a demand for more sophisticated strategies for cloning, mutagenizing, labeling, detecting, and amplifying DNA, and that to meet this demand there is an increasing need to modulate a range of DNA polymerase (pol) properties (Wu p. 1 para. 1). Wu teaches that processivity and catalytic properties are useful to modulate, as high processivity is important for efficiently copying simple repetitious sequences (Wu p. 1 para. 1). Wu teaches that adding DNA binding domains to DNA polymerases increases processivity (Wu p. 2 para. 3). Wu teaches fusion of the DNA binding protein Sso7d to the DNA polymerase Dbh, which leads to increased processivity (Wu p. 2 “Sso7d fusion increased the processivity of Dbh”). Wu teaches that the sequence of Sso7d is set forth in reference 36, Gao et al. (Wu p. 9 “Construction of the Sso7d-dbh fusion”). The Sso7d protein sequence of Gao is deposited as 1BNZ, or UniProt accession P39476 (see Gao p. 786 “Coordinates”; UniProt reference). This sequence is 98.4% identical to instant SEQ ID NO: 5 (see sequence alignment in OA appendix).
Regarding claim 10, the sequence of Wu is 98.4% identical to instant SEQ ID NO: 5, with 62 out of 63 residues matching (see sequence alignment in OA appendix). The difference between SEQ ID NO: 5 and the sequence of Wu is a conservative substitution of Q to E at position 14 (see sequence alignment in OA appendix). A conservative substitution is one in which the amino acids have similar properties and therefore can be substituted for each other with minimal difference to the protein function (see instant specification p. 17 para. 70). Thus, it would have been obvious for a skilled artisan to utilize a protein with a conservative substitution in place of the protein taught by Wu (i.e. SEQ ID NO: 5), as these would be expected to have the same function.
Regarding claim 11, Wu teaches that the DNA binding domain is attached to the N-terminus of the polymerase (Wu p. 2 para. 5; Fig. 1).
Regarding claim 12, Wu teaches that the DNA binding domain is attached to the N-terminus via a flexible linker, which relieves steric constraints (Wu p. 2 “Generation of Sso7d-Dbh fusion protein”).
It would have been obvious for a skilled artisan to modify the DNA polymerase of Mazur and add a DNA binding domain with a sequence according to SEQ ID NO: 5 to the N-terminus of the polymerase with a linker. Both Mazur and Wu are directed to modified DNA polymerases. Wu teaches that DNA binding domains, including Sso7d, have been added to DNA polymerases for enhanced processivity. It would have been obvious to a skilled artisan that the DNA polymerase taught by Mazur could be similarly modified in this way.
A person of ordinary skill in the art would have been motivated to make this modification to the DNA polymerase of Mazur because Wu teaches that the fusion of a DNA binding domain to the N-terminus of DNA polymerases confers benefits such as improved processivity. Improving processivity and other properties of DNA polymerases is of interest given the use of DNA polymerases in molecular biology techniques, and high processivity allows for more efficient copying of sequences (Wu p. 1 para. 1). Thus, a skilled artisan would have been motivated to modify the DNA polymerase of Mazur with a DNA binding domain as taught by Wu to obtain a polymerase with enhanced processivity, which is beneficial when using the polymerase for biotechnological purposes.
A skilled artisan would have had a reasonable expectation of success in making this modification to the polymerase of Mazur because Wu teaches that adding a DNA binding domain is a known technique for modifying DNA polymerases with beneficial results, and further exemplifies successful fusion of the DNA binding domain to the N-terminus of a DNA polymerase with an amino acid linker. Thus, a person having ordinary skill in the art could expect success in making this same modification to a different DNA polymerase as taught by Mazur.
Conclusion
Claims 1-12 and 25 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
Prosecution Insights