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 5, 21 and amendment of claim 1, 8 and the addition of new claims 22-25, in the paper of 6/8/2026, is acknowledged. Applicants' arguments filed on 6/8/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 3, 4, 6-9, 11, 13, 14, 18, 19, 22-24 are still at issue and are present for examination.
Election/Restrictions
Applicant's election with traverse of the invention of Group 1, claims 1-9, 11, 15-21, to a DNase variant, in the paper of 1/14/2026, is acknowledged. Applicant's election with traverse of the following species:
Species Group 1: Y182H;
Species Group 2: S68;
Species Group 3: P in position 22, L in position 27, P in position 39, G in position 42, D in position 11;
Species Group 5: W57S;
in the paper of 1/14/2026, is acknowledged.
It is noted that applicants did not elect a species from Species groups 4, 6 and 7.
Claims 13, 14 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Claim Objections
Claims 3, 4, 6-8, 18, 19 are objected to because of the following informalities:
Claims 3, 4, 6-8, 18, 19 depend from rejected claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1, 5, 9, 11, 15, 16, 17 under 35 U.S.C. 102(a)(1) as being anticipated by Beier et al. (WO 2018/011276) is withdrawn based upon applicants amendment of the claims in the paper of 6/8/2026.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 9, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beier et al. (WO 2018/011276) and Zhu et al. (Proceedings of the National Academy, Vol 113, No. 46, pp 12496-12951, Nov 2016).
As stated previously, Beier et al. (WO 2018/011276) teach Bacillus CIBI DNase variants and uses thereof. Beier et al. (WO 2018/011276) teach detergent compositions comprising DNase variants exhibiting alterations relative to the parent DNase in one or more properties including wash performance, detergent stability and/or storage stability. Beier et al. (WO 2018/011276) teach a DNase variant comprising the amino acid sequence of SEQ ID NO:1 (90.1% sequence identity to instant SEQ ID NO:1). Beier et al. (WO 2018/011276) teach the above DNase variant of SEQ ID NO:1 comprising a S68V, S68I, S68W and S68L substitutions (see page 2lines 22 thru 35 and supporting text).
Zhu et al. disclose analysis characterizing hydrophobicity of amino acid side chains in a protein environment via measuring contact angle of a water nanodroplet on planar peptide network. Zhu et al. teach that expectedly, all of the planar peptide networks with nonpolar amino acids are hydrophobic due to θ > 90°, whereas all of the planar peptide networks of the polar and charged amino acids are hydrophilic due to θ < 90°. Planar peptide networks of the charged amino acids exhibit complete-wetting behavior due to θ = 0. Zhu et al. disclose that the amino acids comprising nonpolar side chains include isoleucine, alanine, phenylamine, leucine, methionine, proline, valine and tryptophan (Table 1, p 12948).
Before the effective filing date, one of ordinary skill in the art would have been motivated to make similar amino acid substitutions at position S68 of the DNase taught by Beier et al. as a means of identifying DNase variants with improved properties including wash performance, detergent stability and/or storage stability. The obvious amino acid substitutions include those amino acids with similar nonpolar amino acid side chains as taught by Beier et al. which include valine, isoleucine, tryptophan and leucine (i.e. S68V, S68I, S68W and S68L). The obvious amino acids include other nonpolar amino acids such as methionine (i.e. S68M) as taught by Zhu et al.. The expectation of success is high based upon the high level of skill in the art of recombinant protein engineering as exemplified by the teachings of Beier et al. who teach all the methods required to make the obvious DNase variants.
Thus claim(s) 1, 9, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beier et al. (WO 2018/011276) and Zhu et al. (Proceedings of the National Academy, Vol 113, No. 46, pp 12496-12951, Nov 2016).
Remarks
No claim is allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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rgh
7/24/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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