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 .
Applicant’s amendment of claims 1 and 11, in the paper of 2/11/2026, is acknowledged. Applicants' arguments filed on 2/11/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 6-11 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.
Newly amended claim 11 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Each of the polymerases of newly amended claim 11 (SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17 and SEQ ID NO:18) are independent and distinct from the elected invention of SEQ ID NO:12 (Group 4, paper of 8/13/2025) and they lack the same or corresponding special technical
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 11 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 6-10 and 11 are withdrawn from further consideration by the examiner,
37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim(s) 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection was stated in the previous office action as it applied to previous claims 1 and 11. In response to the rejection applicants have amended claims 1 and 11 and traverse the rejection as it applies to the newly amended claims. It is noted that applicants amendment of claim 11 has resulted in its removal from the rejection.
Applicants traverse the rejection as it applies to amended claim 1 on the basis that applicants have amended claim 1 to a polymerase comprising the amino acid sequence according to SEQ ID NO: 12 or a polymerase having at least 90% 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.
Applicants submit that amended claim 1 encompasses a polymerase comprising the amino acid sequence of SEQ ID NO:12 or a polymerase having at least 90% sequence identity to SEQ ID NO:12 as long as it has an N-terminal 5'-3' nuclease domain from a Taq polymerase and an adjacent and linked polymerase domain from a viral family A polymerase. Applicants submit that thus, not only does amended claim 1 have a structural characteristic but the structural characteristic is the result of the fusion of the Taq polymerase 5'-3' nuclease domain and a viral pol domain which is exactly what the Office Action agrees is supported.
Applicants amendment of the claims and applicants complete argument is acknowledged and has been carefully considered, however, is not found persuasive for the reasons previously stated and for those reasons repeated herein. As stated above, it is noted that applicants amendment of claim 11 has resulted in its removal from the rejection.
In response to applicants amendment and arguments regarding claim 1, claim 1 is now drawn to any polymerase comprising the amino acid sequence according to SEQ ID NO: 12 or a polymerase having at least 90% 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. Applicants submission that amended claim 1 encompasses a polymerase comprising the amino acid sequence of SEQ ID NO:12 or a polymerase having at least 90% sequence identity to SEQ ID NO:12 as long as it has an N-terminal 5'-3' nuclease domain from a Taq polymerase and an adjacent and linked polymerase domain from a viral family A polymerase is not an accurate representation of the claimed subject matter with regard to claim 1. As stated above, claim 1 is now drawn to any polymerase comprising the amino acid sequence according to SEQ ID NO: 12 or a polymerase having at least 90% 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. It is noted that with regard to SEQ ID NO:12, applicants claimed polymerase is drawn to either the polymerase comprising SEQ ID NO:12, which comprises an N-terminal 5'-3' nuclease domain from a Taq polymerase and an adjacent and linked polymerase domain from a viral family A polymerase or a polymerase having at least 90% 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. As that portion of SEQ ID NO:12 which comprises an N- terminal 5'-3' nuclease domain from a Taq polymerase and an adjacent and linked polymerase domain from a viral family A polymerase are not subject to change within the construct of SEQ ID NO:12 or they would no longer be an N- terminal 5'-3' nuclease domain from a Taq polymerase and an adjacent and linked polymerase domain from a viral family A polymerase, applicants have not described a single polymerase at least 90% 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.
Given this lack of description of species as encompassed by the claims, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Closest Prior Art
WO 2019/211749 (Qiagen Beverly LLC) discloses polymerases comprising an N-terminal 5’-3’ nuclease domain stemming from Taq polymerase and an adjacent linked polymerase domain stemming from a viral family A polymerase. The sequence identity of the polymerase fusion taught by WO 2019/211749 (Qiagen Beverly LLC) to instant SEQ ID NO:12 is 87.8%.
Remarks
No claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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rgh
4/13/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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