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 cancellation of claims 1-8, 13, amendment of claims 10-12, 14-16, 18-20 and the addition of new claims 21-23, in the paper of 4/26/2026, is acknowledged. Applicants' arguments filed on 4/26/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 9-12, 14-23 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of the invention of Group 1, claims 1-12, 14-18, to a MMLR reverse transcriptase composition comprising a peptide extension, in the paper of 11/24/2025, is acknowledged. Applicant's election without traverse of the invention of Species Group 1 species , SEQ ID NO:732, Species Group 2 species , Q68R and Q79R, Species Group 3 species, enhanced thermostability, in the paper of 11/24/2025, is acknowledged.
Claims 10 and 19-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Specification
The disclosure is objected to because of the following informalities:
Previously applicants specification was objected to because it refers to amino acid positions that do not match the reference sequence. It was noted that tor example “Q68R” and “Q79R” are each refenced relative to the amino acid sequence of SEQ ID NO:674, however, position 68 of SEQ ID NO:674 is a serine residue not a glutamine residue. Similarly position 79 of SEQ ID NO:674 is a isoleucine residue not a glutamine residue.
In response applicants submit that at page 58 of the application as filed they explain that with respect to the present disclosure and for the purpose of identifying and numbering residues in the MMLV RTase amino acid sequence where amino acid mutations have been introduced, the N-terminal methionine is considered amino acid “)” and the second residue is considered to be amino acid residue 1.
Applicants complete argument is acknowledged and has been carefully considered, however, is not found persuasive for the following reasons.
Based upon applicants above comments and applicants specification at page 58, the previous reference to “Q68R” and “Q79R” relative to the amino acid sequence of SEQ ID NO:674 has been clarified. See below the relevant position of SEQ ID NO:674 with the adjustments made that the second residue of SEQ ID NO:674 is position 1:
SEQ ID NO: 674 (Applicants stated numbering shown above sequence):
60 Q68R Q79R L82Y L99R
SIKQYPMSRE ARLGIKPHIR RLLDQGILVP CQSPWNTPLK
Applicants specification also references “L82Y” and “L99R” relative to SEQ ID NO:674. Position L82Y and L99R are also shown above given applicants stated adjusted numbering. It is noted that the amino acid residue at position 82 is “L” (original amino acid) as opposed to the substituted “R” (substituted amino acid) at positions 68 and 79. This brings up the question of maintaining consistency in referencing amino acid positions and amino acid substitutions at the positions relative to a specific reference sequence of SEQ ID NO: 674.
Further as can be seen above given applicants stated adjusted numbering, position 99 is a “K” not a “L” or “R”, as one might expect in referencing “L99R”.
The above illustrated inconsistency in applicants referencing amino acid positions and mutations is objected to as being confusing and unclear.
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.
Claims 9, 11, 12, 14-18, 21-23 are 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 9 (claims 11, 12, 14-18, 21-23 dependent on) continues to be indefinie in referencing amino acid positions and mutations relative to the reference amino acid sequence of SEQ ID NO:674.
As discussed above under the objection to applicants specification, claim 9 was similarly rejected for being indefinite in referencing “a glutamine to arginine substitution at position 68 (Q68R)” and “a glutamine to arginine substitution at position 79 (Q79R)” relative to the amino acid sequence of SEQ ID NO: 674.
In response to this rejection, Applicant contends that, as above, as clarified on page 58 of the specification, one of skill of the art would understand that the amino acid substitutions noted in the specification and claims consider the threonine amino acid residue 1, and therefore the amino acid substitutions noted in the specification and claims are in alignment. Applicant contends that the specification clearly sets forth a special definition of the claim term in the specification, and thus the amino acid substitutions recited in the claims are clear.
Applicants complete argument is acknowledged and has been carefully considered, however, is not found persuasive for the following reasons.
Based upon applicants above comments and applicants specification at page 58, the previous reference to “Q68R” and “Q79R” relative to the amino acid sequence of SEQ ID NO:674 has been clarified. See below the relevant position of SEQ ID NO:674 with the adjustments made that the second residue of SEQ ID NO:674 is position 1:
SEQ ID NO: 674 (Applicants stated numbering shown above sequence):
60 Q68R Q79R L82Y L99R
SIKQYPMSRE ARLGIKPHIR RLLDQGILVP CQSPWNTPLK
Applicants claim also references “L82Y” and “L99R” relative to SEQ ID NO:674. Position L82Y and L99R are also shown above given applicants stated adjusted numbering. It is noted that the amino acid residue at position 82 is “L” (original amino acid) as opposed to the substituted “R” (substituted amino acid) at positions 68 and 79. This brings up the question of maintaining consistency in referencing amino acid positions and amino acid substitutions at the positions relative to a specific reference sequence of SEQ ID NO: 674.
Further as can be seen above given applicants stated adjusted numbering, position 99 is a “K” not a “L” or “R”, as one might expect in referencing “L99R”.
The above illustrated inconsistency in applicants referencing amino acid positions and mutations renders the claim indefinite.
Appropriate correction and/or comment is required.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1-5, 11, 12, 14-18 under 35 U.S.C. 102(a)(1) as being anticipated by Hogrefe et al. (US 2008/0227661) is withdrawn based upon applicants cancellation of claims 1-5 and amendment of claims 11, 12, 14-18 to depend from claim 9.
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.
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
6/11/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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