DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on April 6, 2026 has been entered. The claims pending in this application are claims 1-15 wherein claims 12-15 have been withdrawn due to the restriction requirement mailed on September 11, 2025. The objections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on April 6, 2026. Claims 1-11 will be examined.
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.
Claims 1-5 and 7-11 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Wurst (US Patent No. 5,976,842, published on November 2, 1999).
Regarding claims 1, 3-5, 7, and 8, since it is known that Taq DNA polymerase lack of 3’ to 5’ exonuclease proofreading activity (see page 1 of “Taq polymerase” from Wikipedia), Wurst teaches a composition for performing an amplification reaction of a nucleic acid template, the composition comprising a) buffer, b) a DNA polymerase (eg., Taq polymerase), c) one or more primers and d) a mixture of deoxynucleotides (dNTPs), wherein the mixture of dNTPs comprises a higher dATP concentration (eg., 500 µM) than a concentration of either dGTP, dCTP or dTTP (eg., 100 µM) and the dGTP, dCTP and dTTP are present at equimolar concentrations (eg., 100 µM) as recited in claim 1 wherein the amplification reaction is a polymerase chain reaction (PCR) as recited in claim 3, the DNA polymerase (e.g, Taq polymerase) lacks a 3’-5’ exonuclease activity as recited in claim 4, the DNA polymerase (e.g, Taq polymerase) is a thermostable polymerase as recited in claim 5, the DNA polymerase is a Taq polymerase as recited in claim 7, the concentration of the nucleic acid template ranges from 8pg to 8ng (ie., 1 ng) as recited in claim 8 (see columns 3, 4, and 7-9, and Table 4).
Regarding claim 2, since Wurst teaches that “[I]n the subject invention, unequal amounts of deoxyribonucleoside triphosphates (dNTPs) are employed. By unequal amounts is meant that at least one of the different types of dNTPs is present in the reaction mixture in an amount that differs from the amount at which the other dNTPs are present, i.e. a unique amount. The amount of difference will be at least about 1.5 and usually at least about 2” (see column 4, second paragraph) and the at least one of the different types of dNTPs taught by Wurst can be dATP, Wurst discloses that the concentration of dATP is between 1.5 fold and 2.5 fold or between 1.8 fold and 2.2 fold or between 1.9 fold and 2.1 fold in excess over the concentration of dGTP, dCTP or dTTP.
Regarding claims 9-11, since a nucleic acid template is not a structural limitation of claim 1 and the composition recited in claim 1 can be used for performing an amplification reaction of the nucleic acid template recited in claims 9-11, claims 9-11 are anticipated by Wurst.
Therefore, Wurst teaches all limitations recited in claims 1-5 and 7-11.
Response to Arguments
In page 7, first to last paragraphs of applicant’s remarks, applicant argues that “[T]he Office Action alleges that Wurst describes the claimed composition comprising a buffer, a DNA polymerase, one or more primers and a mixture of deoxynucleotides (dNTPs), wherein the mixture of dNTPs comprises a higher dATP concentration than that of either dGTP, dCTP or dTTP. Applicant respectfully disagrees with the rejection as it pertains to the currently amended claims. Wurst describes compositions for performing high fidelity polymerase chain reactions with a low error frequency rate through the use of unequal concentrations of dNTPs. Wurst states that dATP can be present in a concentration greater than the individual concentrations of the remaining three dNTPs, however, Applicant submits that Wurst fails to specifically teach ‘wherein the dGTP, dCTP and dTTP are present at equimolar concentrations’ as currently claimed. Thus, regardless of whether Wurst describes unequal amounts of dATP compared to dGTP, dCTP and dTTP, Wurst fails to further teach the relationship between the dGTP, dCTP and dTTP, specifically ‘wherein the dGTP, dCTP and dTTP are present at equimolar concentrations.’ For at least this reason, Applicant respectfully requests withdrawal of the rejection and reconsideration of claims 1-5 and 7-11”.
The above argument has been fully considered but it is not persuasive toward the withdrawal of rejection because Wurst teaches that the dGTP, dCTP and dTTP are present at equimolar concentrations as argued by applicant (see Table 4).
Claim 6 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Wurst applied to claims 1-5 and 7-11 above as evidence by Clark (Nucleic Acids Research, 16, 9677-9686, 1988).
Since Clark teaches that Taq polymerase has an ability to perform a non-templated nucleotide addition reaction (see abstract in page 9677 and pages 9679 and 9680), Wurst as evidence by Clark disclose that the DNA polymerase (e.g, Taq polymerase) can add non-template nucleotides to amplified nucleic acid strands as recited in claim 6.
Response to Arguments
In page 8, first to third paragraphs of applicant’s remarks, applicant argues that “[T]he Office Action relies on Wurst for the same reasons described above. The Office Action relies on Clark for providing evidence that the Taq polymerase has an ability to perform a non-templated nucleotide addition reaction. Regardless of whether Clark evidences that the Taq polymerase has an ability to perform a non-templated nucleotide addition reaction, the combination of Wurst and Clark fails to teach ‘wherein the dGTP, dCTP and dTTP are present at equimolar concentrations’ as currently claimed”.
The above argument has been fully considered but it is not persuasive toward the withdrawal of rejection because Wurst teaches that the dGTP, dCTP and dTTP are present at equimolar concentrations as argued by applicant (see Table 4).
Conclusion
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.
No claim is allowed.
Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993)(See 37 CAR § 1.6(d)). The CM Fax Center number is (571)273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph.D., whose telephone number is (571)272-0746. The examiner can normally be reached on Monday-Friday from 9 A.M. to 5 P.M.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Dr. Anne Gussow, Ph.D., can be reached on (571)272-6047.
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/FRANK W LU/Primary Examiner, Art Unit 1683
June 22, 2026
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