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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/17/2026 has been entered.
Applicant’s cancellation of claim 11 and amendment of claims 1, in the paper of 8/17/2026, is acknowledged. Applicants' arguments filed on 8/17/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 and 6-10 are still at issue and are present for examination.
Election/Restrictions
Applicant's election of the invention of Group 4, claims 1, 8, 11 to a polymerase of SEQ ID NO:12, in the paper of 9/26/2025, is acknowledged. Applicant's election without traverse of the invention of following species: Species Group 3: V754K, in the paper of 9/26/2025, is acknowledged.
Claims 6-10 are withdrawn from further consideration by the examiner,
37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “at least 85% sequence identity to an amino acid sequence according to SEQ ID NO:12” which should be “at least 85% sequence identity to the amino acid sequence according to SEQ ID NO:12”.
Claim 1 recites “the polymerase having at least 85% identity to the amino acid sequence” which should be “the polymerase having at least 85% sequence identity to the amino acid sequence”.
Appropriate correction is required.
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 1 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 1 is indefinite in the recitation in part iv): “or an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO. 17 comprising the amino acid changes Q627N, H752Q, Q753K, and I754K”, because “I754” does not exist in SEQ ID NO:17.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Suhman et al. (WO 2019/211749; US patent 11,807,667 and US 2021/0171580).
Suhman et al. WO 2019/211749; US patent 11,807,667) discloses engineered polypeptides that support both reverse transcription and DNA amplification in manganese-independent reactions. Suhman et al. disclose that methods using these polypeptides for amplifying template nucleic acids using such polypeptides. Suhman et al. disclose a polypeptide comprising a polymerase domain and comprises the amino acid sequence of SEQ ID NO:14, which has greater than 90% sequence identity to instant SEQ ID NO:15 and greater than 85% sequence identity to instant SEQ ID NO:12. Suhman et al. further teach that the polypeptide of SEQ ID NO:14 preferably comprises the substitutions: H751Q, Q752K, L753K and Q627N, which correspond to H751Q, Q752K, V753K and Q628N of instant SEQ ID NO:15.
Thus, claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Suhman et al. (WO 2019/211749; US patent 11,807,667 and US 2021/0171580).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 15 of U.S. Patent No. 11,807,667. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 and 15 of U.S. Patent No. 11,807,667 drawn to an polypeptide comprising a first amino acid sequence and a second amino acid sequence, wherein the first amino acid sequence comprises an amino acid sequence of SEQ ID NO:16 or an amino acid sequence at least 90% identical to SEQ ID NO:16, and wherein the second amino acid sequence is selected from the group consisting of SEQ ID NO:17 and SEQ ID NO:72, or an amino acid sequence at least 90% identical to SEQ ID NO:17 or SEQ ID NO:72, wherein the polypeptide has polymerase activity wherein the polypeptide comprises an amino acid sequence of SEQ ID NO:14 or an amino acid sequence at least 90% identical thereto, given that the polypeptide of SEQ ID NO:14 preferably comprises the substitutions: H751Q, Q752K, L753K and Q627N, which correspond to H751Q, Q752K, V753K and Q628N of instant SEQ ID NO:15, anticipate/make obvious instant claim 1 drawn to a polymerase comprising: a) the amino acid sequence according to SEQ ID NO: 12; or b) a polymerase having at least [[90%]]85%sequence identity to an amino acid sequence according to SEQ ID NO:12 comprising an N-terminal 5'-3' nuclease domain from a Taq polymerase and an adjacent and linked polymerase domain from a viral family A polymerase, wherein the polymerase having at least 85% identity to the amino acid sequence according to SEQ ID NO:12 comprises: i)the amino acid sequence of SEQ ID NO: 15 comprising amino acid changes Q627N, H75 1Q, Q752K, and V753K, or an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO: 15 comprising the amino acid changes Q627N, H75 1Q, Q752K, and V753K; ii) the amino acid sequence of SEQ ID NO. 16 comprising amino acid changes Q627N, H752Q, Q753K, and V754K, or an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO. 16 comprising the amino acid changes Q627N, H752Q, Q753K, and V754K; iii) the amino acid sequence of SEQ ID NO. 17 comprising amino acid changes Q628N, H752Q, Q753K, and L754K, or an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO. 17 comprising the amino acid changes Q628N, H752Q, Q753K, and L754K;or iv) the amino acid sequence of SEQ ID NO. 18 comprising amino acid changes Q627N, H752Q, Q753K, and I754K, or an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO. 17 comprising the amino acid changes Q627N, H752Q, Q753K, and I754K.
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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rgh
9/17/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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