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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 4/28/2026 has been entered.
Applicant’s amendment of claims 1, 5, 15, in the paper of 4/28/2026, is acknowledged. Applicants' arguments filed on 4/28/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 1, 5, 6, 9, 11, 12, 15, 18 and 21 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of the invention of Group 1, claims 1, 2, 4, 5, 13-19 and 21, to a protein having DNA polymerase activity, in the paper of 8/27/2025, is acknowledged. Applicant's election without traverse of the following species:
Species Group 1: position 485;
Species Group 2: position 451;
Species Group 3: position 451;
Species Group 4: KH222 (E485I+S451L);
Species Group 5: position 453;
Species Group 6: KH227 (E485I+L453A);
Species Group 7: position 465 and 584;
Species Group 8: QH305 (E485I+K465Q+K584T);
Species Group 9: positions 465, 718 and 480;
in the paper of 8/27/2025, is acknowledged.
Claims 6, 9, 11 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites “wherein the protein is further added with a first tag sequence at the terminal of the protein” which is awkward. It is suggested this be amended to ““wherein the protein further comprises a tag sequence at the terminus of the protein”.
Appropriate correction and/or comment 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.
The rejection of claim(s) 1 and 12 under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 9,765,309) is withdrawn based upon applicants amendment of the claims in the paper of 4/1/2026.
Claim(s) 1, 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 9,765,309) and BGI Research WO 2020047695-A1.
Chen et al. (US 9,765,309) teach modified recombinant DNA polymerases for improved incorporation of nucleotide analogs, in particular nucleotides which are modified at the 3’ sugar hydroxyl, as well as methods and kits using the same. Chen et al. teach an altered family B archael DNA polymerase comprising a substitution mutation functionally equivalent to A485L or A485V in the 9oN polymerase sequence. Chen et al. further teach additional mutations in said modified DNA polymerase and methods of using said modified DNA polymerase to amplify and sequence nucleic acids.
BGI Research WO 202004769541 teach a number of recombinant KOD polymerases and KOD polymerase mutants useful for preparing DNA polymerization applications. BGI Research WO 202004769541 teach a KOD polymerase mutant which is derived from SEQ ID NO: 1 of BGI Research and modified as provided in example 2 which is 100% identical to instant SEQ ID NO:1.
One of skill in the art before the effective filing date would have been motivated to modify the DNA polymerase taught by BGI Research WO 202004769541 with similar amino acid substitutions at the positions taught by Chen et al. for its use in nucleic acid synthesis reactions. One would have been motivated to modify the substitutions with amino acids with similar properties, such as hydrophobicity characteristics. As Chen et al. teach the substitution of A485 with the hydrophobic side chain amino acids “L” and “V”, one would have been motivated to substitute other similar amino acids such as “I”. Thus one of would have been motivated to create a A485I substitution in the background of the polymerase taught by BGI Research WO 202004769541. One would have been further motivated to modify the protein of Chen et al. with an additional tag on the terminus of the protein for use in isolating the protein. The expectation of success is high based upon the high degree of skill in the art in the area of recombinant protein engineering as exemplied by Chen et al. and BGI Research WO 202004769541.
Claim(s) 1, 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 9,765,309) and BGI Research WO 202004769541.
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.
The rejection of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (US 9,765,309) is withdrawn based upon applicants amendment of the claim in the paper of 4/1/2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 5, 12, 15, 18 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11, 14, 15 of copending Application No. 18/564,400 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-7, 14, 15 of copending Application No. 18/564,400 (reference application) drawn to a mutant protein, based on a thermostable B-family DNA polymerase and having DNA polymerase activity, wherein the mutant protein is obtained by mutated at positions 408, 409 and 485 at least two amino acid residues of an amino acid sequence of the thermostable B-family DNA polymerase anticipate/make obvious instant claims 1, 5, 12, 15, 18 and 21 drawn to a protein having DNA polymerase activity, wherein the protein has an amino acid sequence with a substitution at position 485 of SEQ ID NO: 1
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants have acknowledged this rejection and stated that they will consider filing a Terminal Disclaimer when allowable claims are indicated in the present application and copending application 18/564,400. Applicants response is being treated as if applicants have asked that the rejection be held in abeyance until the claims are determined to be otherwise allowable.
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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rgh
6/1/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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