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 .
Status of the Application
The Amendment filed March 31, 2026 is acknowledged.
Claims 126-145 are pending and are being examined on the merits.
Response to Arguments
Applicant’s arguments filed Mach 31, 2026 have been fully considered.
The objections and rejections are WITHDRAWN in view of Applicant’s arguments and amendments to the specification, drawings and claims:
Objections to the Drawings
Objections to the Specification – title
Objections to the Specification – cross reference to related applications
Objections to the Specification – trademarks
Objections to claims 126, 130, 124 and 139-145
Rejection of claims 126-140 and 144 under 35 USC § 112(b)
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.
Claim 128 is 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.
Claim 128 contains the trademark/trade name “Bst 3.0 polymerase”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the source of an enzyme and, accordingly, the identification/description is indefinite.
Prior Art and Allowable Subject Matter
Claims 126-145 are free of the art.
The closest prior art is Stromberg1 (US 2018/0305749 A1, filed March 15, 2018), Bebenek2 (The effects of dNTP pool imbalances on frameshift fidelity during DNA replication, J Biol Chem, 267(6): 3589-3596, 1992), and Cadwell3 (Randomization of Genes by PCR Mutagenesis, PCR Methods Appl, 2(1): 28-33, 1992).
Stromberg is directed to contacting a primed nucleic acid sequence with a series of mixtures of nucleotides and then monitoring incorporation of the nucleotides to determine the nucleic acid sequence. Regarding independent claim 126, Stromberg teaches using mixtures of different types of nucleotides, but does not teach or suggest selecting a subset of nucleotides and incorporating nucleotides into the nucleic acid molecule that do not correspond to the subset in such a way as to increase the percentage of the subset nucleotides relative to the non-subset nucleotides in the mixture, nor does it teach or suggest incorporating nucleotides into a nucleic acid molecule in the absence of sequencing the nucleic acid molecule.
Regarding independent claim 130, Stromberg also does not teach or suggest selecting a subset of nucleotides and incorporating nucleotides into the nucleic acid molecule that correspond to the subset in such a way as to decrease the percentage of the subset nucleotides relative to the non-subset nucleotides in the mixture, nor does it teach or suggest incorporating nucleotides into a nucleic acid molecule in the absence of sequencing the nucleic acid molecule.
Regarding independent claim 141, Stromberg also does not teach or suggest selecting a subset of nucleotides and incorporating nucleotides into the nucleic acid molecule that correspond to the subset, thereby generating a remainder of nucleotides, where the remainder of nucleotides are used to perform nucleic acid synthesis, nor does it teach or suggest incorporating nucleotides into a nucleic acid molecule in the absence of sequencing the nucleic acid molecule.
Bebenek is directed to examining nucleotide pool bias effects on frameshift fidelity during DNA synthesis. Bebenek teaches applying mixtures of different types and amounts of nucleotides to nucleic acid molecules, and teaches doing so in a context that does not involve sequencing the nucleic acid molecule. Specifically, instead of sequencing, Bebenek is using a frameshift fidelity assay to determine nucleotide incorporation into the target nucleic acid molecule. However, Bebenek does not remedy the other deficiencies of Stromberg, discussed above.
Cadwell is directed to PCR mutagenesis of genes using nucleotide pools with various proportions of nucleotides. Cadwell teaches applying mixtures of different types and proportions of nucleotides to nucleic acid molecules to induce mutagenesis, and then detects the mutated nucleic acid with sequencing. However, Cadwell does not remedy the deficiencies of Stromberg, discussed above.
Claims 126-127 and 129-145 are allowed.
Claim 128 is free of the art, but stands rejected under 35 USC § 112(b), as noted above.
Conclusion
Claims 126-145 are being examined. Claim 128 is rejected. Claims 126-127 and 129-145 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 Stromberg was cited in the Information Disclosure Statement filed June 18, 2023.
2 Bebenek was cited in the PTO-892 Notice of References Cited mailed January 8, 2026.
3 Cadwell was cited in the PTO-892 Notice of References Cited mailed January 8, 2026.
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