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 .
The Response of 29 April 2026 has been entered.
Claims 1 and 3-12 are currently pending.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1 and 3-6, and the species of SEQ ID 16 as the first TdT variant and SEQ ID 14 as the second TdT variant in the reply filed on 29 April 2026 is acknowledged.
Claims 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 29 April 2026.
In the interest of compact prosecution, the species election requirement for species of first and second variants is hereby withdrawn.
Claim Rejections - 35 USC § 112(a) (written description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1 and 3-6 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a method of synthesizing a polynucleotide comprising repeated steps of elongating an initiator via incorporation of a 3'-O-blocked NTP with TdT, wherein the method comprises elongation with a first TdT variant with a first set of 3'-O-blocked NTPs and elongation with a second TdT variant with a second set of 3'-O-blocked NTPs, the first variant elongating the initiator with a greater efficiency than the second variant from the first set and the second variant elongating the initiator with a greater efficiency than the first variant from the second set. Claim 1 is not limited with respect to the identity of the first or second variants nor the identity of the first or second sets of 3'-O-blocked NTPs (either with respect to the base or the protecting group). Thus, claim 1 encompasses a large genus of potential TdT variants having differential activity with respect to some undefined set of 3'-O-blocked NTPs.
To show possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus, which in the case of a chemical invention requires a precise definition, such as by structure, formula, chemical name, or physical properties (MPEP 2163). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species sufficient to show the applicant was in possession of the claimed genus; A "representative number of species" means that the species which are adequately described are representative of the entire genus (MPEP 2163).
The instant specification discloses i) a first variant, termed an ACT-TdT variant, which has enhanced efficiency with respect to A, C and T 3'-O-blocked NTPs and contains the substitutions set forth in instant claims 3 and/or 4 relative to a base sequence of SEQ ID 1; and ii) a second variant, termed an G-TdT variant, which has enhanced efficiency with respect to G 3'-O-blocked NTPs and contains the substitutions set forth in instant claims 5 and/or 6 relative to a base sequence of SEQ ID 1 (Published Spec. 20220411840, [0013]-[0014]; Example 1). The specification does not describe additional variants representative of the scope of the claims, such as variants not based on the above substitutions or variants having preferential activity with respect to different types of blocking groups. The specification also fails to provide any structure-function relationship or other teachings/guidance that would allow one of ordinary skill to identify variants commensurate in scope with the claimed genus (e.g., which portions of the enzyme outside of the substitutions in claims 3-6 can be modified and/or which portions are responsible for the claimed functionality). While claims 3-4 limit the claims with respect to the first variant and the first set of 3'-O-blocked NTPs and claims 5-6 limit the claims with respect to the second variant and the second set of 3'-O-blocked NTPs, claims 3-6 leave one of the first and second variants and the corresponding NTP set undefined and are thus not commensurate with the scope of the written description support in the specification.
The following subject matter would be considered as having written description support in the specification: the method of claim 3 further limited by the limitations of claim 5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
