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 1-9, 17-25, 27-29, 31, 33-35, 37-39, 41-43, 45-47, 49, 51, 53-55, 57-59, 61-63, 71, 74, 92, and 103, in the reply filed on 05/21/2026 is acknowledged.
Applicant's election with traverse of the species of SEQ ID NO: 4 in the reply filed on 05/21/2026 is acknowledged. The traversal is on the ground(s) that searching all of the sequences of claim 1 would not present an undue search burden on the Examiner. This argument is not found persuasive because, contrary to Applicant’s assertion, individually searching each of the many thousands of sequences encompassed by the full scope of instant claim 1 would clearly represent an undue burden of search on the Examiner.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 05/21/2026 has been entered. Claims 1-9, 17-25, 27-29, 31, 33-35, 37-39, 41-43, 45-47, 49, 51, 53-55, 57-59, 61-63, 71, 74, 78, 84, 87, 89, 92, 98, and 103 are pending in this US patent application. Claims 78, 84, 87, 89, and 98 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/21/2026. Claims 2, 5-8, 17, 20, 22-25, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/21/2026.
Claims 1, 3-4, 9, 18-19, 21, 27-29, 33-35, 37-39, 41-43, 45-47, 49, 51, 53-55, 57-59, 61-63, 71, 74, 92, and 103 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 10/16/2024 has been received and considered.
Election/Restrictions
Applicant’s elected species of SEQ ID NO: 4 is allowable. The closest prior art to the claimed invention is found in the teachings of UniProt listing C6ZCU5_9CAUD, discussed below under Claim Rejections – 35 USC 102. However, this reference does not teach or suggest a protein consisting of the sequence of SEQ ID NO: 4. In light of the allowability of the sequence of SEQ ID NO: 4, the Examiner has selected another polypeptide within the scope of instant claim 1, an RNA polymerase with at least 80% sequence identity to SEQ ID NO: 2 but none of the particular substitutions recited in the instant claims, for examination with respect to the prior art. In light of the Examiner’s selection, claims 3-9, 17-25, 27-29, 31, 33-35, 37-39, 41-43, 45-47, 49, 51, 53-55, 57-59, 61-63, 71, and 74 are newly withdrawn as being drawn to non-elected species.
Claims 1-2 and 103 are currently under examination and were examined on their merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 and 103 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The claims recite at least one protein that is naturally occurring (see phage RNA polymerase discussed below under Claim Rejections – 35 USC 102). Stating that the polymerase is ‘engineered’ does not impose a structural limitation on the enzyme, and so this word in the claims does not represent a marked difference from a judicial exception.
This judicial exception is not integrated into a practical application because the instant claims contain no elements other than the naturally occurring polymerase itself. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims 1-2 recite no elements other than the naturally occurring polymerase, and the ‘kit’ of claim 103 is not limited in any way, so it encompasses, for example, the naturally occurring phage in which the polymerase is found in nature.
Therefore, claims 1-2 and 103 are rejected under 35 U.S.C. 101 as being directed to patent-ineligible subject matter.
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 1-2 and 103 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProt listing C6ZCU5_9CAUD, published 09/22/2009.
UniProt teaches an RNA polymerase with 88.7% sequence identity with residues 8-890 of instant SEQ ID NO: 2 (see entire document, including pages 3-6; reads on claims 1-2 and 103; the Examiner notes that the phage in which the RNA polymerase naturally occurs may be interpreted as a ‘kit’ as recited in claim 103).
As such, claims 1-2 and 103 are anticipated by UniProt and are rejected under 35 U.S.C. 102(a)(1).
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 Monday-Friday, 7:30-5:00.
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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 06/19/2026
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