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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1-4, and the species of SEQ ID NO: 2 in the reply filed on 06/16/2026 is acknowledged.
Claim Status
The response of 06/16/2026 has been entered. Claims 1-20 are pending in this US patent application. Claims 5-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/16/2026.
Claims 1-4 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 08/11/2023 and 11/12/2025 have been received and considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
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 4 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.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As such, claim 4 is rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claim 4 without the limitation “such as 60%, 70%, 80%, 90%, 95% or 100%”.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as anticipated by international patent application publication WO 2015/085230 filed by Wang et al., published 06/11/2015 (cited on the IDS filed 08/11/2023), as evidenced by Ayyadevara et al., Anal. Biochem. 284: 11-18 (2000), and Xue et al., J. Biol. Chem. 297(5): 101270 (2021).
Wang teaches that Taq polymerase has inherent polymerase and 5’-3’ exonuclease activity but does not have 3’-5’ exonuclease activity (see entire document, including page 2, paragraph 0004; cf. claim 1; the Examiner notes that the term “recombinant” without any further limitations does not convey any structural limitations on the recited polymerase enzyme).
Ayyadevara teaches that Taq polymerase is capable of amplifying DNA templates despite the presence of a mismatched base pair in the primer (see entire document, including page 11, abstract). As such, the Taq polymerase of Wang is intrinsically “capable of extending DNA polymerization from a mismatched base pair” as recited in instant claim 1.
Xue teaches that the error rate of a DNA polymerase is not an intrinsic characteristic of the enzyme but, rather, is affected by the reaction conditions, including the temperature (see entire document, including page 1). As such, the recitation of a particular error rate without any further conditions in claim 1 does not convey a structural distinction upon the enzyme that allows it to be distinguished from the Taq polymerase of Wang.
Therefore, claim 1 is anticipated by Wang, as evidenced by Ayyadevara and Xue, and is rejected under 35 U.S.C. 102(a)(1).
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2012/0115188 filed by Faurholm et al., published 05/10/2012, in view of Trincao et al., Mol. Cell 8(2): 417-426 (2001; cited on the IDS filed 08/11/2023), and Xu et al., J. Mol. Biol. 268: 284-302 (1997).
Faurholm teaches chimeric DNA polymerases containing a first domain having a sequence at least 80% identical to an amino acid sequence found in an exonuclease domain of a first DNA polymerase; and a second domain having a sequence at least 80% identical to an amino acid sequence found in palm and/or fingers domain of a second DNA polymerase (see entire document, including paragraph 0020; cf. claims 1-2).
However, Faurholm does not teach that the exonuclease domain is the exonuclease domain of E. coli DNA polymerase I or that the palm and/or fingers domain are those from S. cerevisiae DNA polymerase η.
Trincao teaches that S. cerevisiae Polη has the palm, fingers, and thumb domains characteristic of all known DNA polymerases, along with a polymerase-associated domain that mimics an extra set of fingers (see entire document, including page 418, right column, paragraph 2; cf. claims 3-4; the Examiner notes that S. cerevisiae Polη is identical to residues 350-981 of SEQ ID NO: 2).
Xu teaches that the 5’-3’ exonuclease of E. coli DNA polymerase I is a separate domain from the more commonly studied Klenow fragment containing the polymerase and 3’-5’ exonuclease domains (see entire document, including page 284, abstract; left column, paragraph 1; and right column, paragraph 1; cf. claims 3-4; the Examiner notes that the 5’-3’ exonuclease domain of E. coli DNA polymerase I is identical to residues 15-337 of SEQ ID NO: 2).
While Faurholm does not teach that the exonuclease domain is the exonuclease domain of E. coli DNA polymerase I or that the palm and/or fingers domain are those from S. cerevisiae DNA polymerase η, it would have been obvious to one of ordinary skill in the art to use any exonuclease domain from a DNA polymerase and any palm/fingers domain from a DNA polymerase to generate the chimeric DNA polymerase of Faurholm, including those taught by Xu and Trincao, respectively. One of ordinary skill in the art would have a reasonable expectation that forming a chimera of the S. cerevisiae polymerase of Trincao and the E. coli exonuclease of Xu would successfully result in the production of a chimeric DNA polymerase with 5’-3’ exonuclease activity (from the E. coli DNA polymerase I exonuclease domain) and the ability to replicate through a variety of distorting DNA lesions (from the S. cerevisiae Polη).
Therefore, claims 1-4 are rendered obvious by Faurholm in view of Trincao and Xu and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Tuesday-Thursday, 6:30-4:00.
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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.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 09/02/2026
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