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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/2025 has been entered.
Applicant’s cancellation of claim 27, 35, amendment of claims 1, 23, in the paper of 12/23/2025, is acknowledged. Applicants' arguments filed on 12/23/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 23-26, 28-34, 36-38 and 40 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of the following species:
Species Group 1): positions 104, 128, and 204;
Species Group 2): position 63.
in the paper of 10/22/2024, is acknowledged.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of claim(s) 1, 23, 27, 29, 32-34, 35-39 under 35 U.S.C. 102(a)(1) as being anticipated by Weisgerber et al. (US 6,495,136) is withdrawn based upon applicants amendment of the claims and arguments presented in the paper of12/23/2025. Specifically Weisgerber et al. (US 6,495,136) does not teach a mutation at position 9 of SEQ ID NO:1.
Claim(s) 1, 23, 24, 25, 26, 28, 29, 30, 32-34, 36-38 and 40 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2016/087617 (equivalent US 2017/0335307).
WO 2016/087617 discloses a number of subtilase variants and polynucleotides encoding them for use in cleaning and detergent compositions such as laundry detergent compositions and dish wash compositions. WO 2016/087617 discloses subtilase variants comprising a number of mutations in the subtilase of SEQ ID NO:2 which has 100% sequence identity to instant SEQ ID NO:1. WO 2016/087617 discloses those subtilase variants of SEQ ID NO:2 (instant SEQ ID NO:1) comprising a mutation at position 9 (S9E), 206, 209 and 216 (see claim 15 and supporting text)(instant claims 1 and 40). WO 2016/087617 discloses those subtilase variants of SEQ ID NO:2 (instant SEQ ID NO:1) comprising a mutation at position 9 (S9E), 206 and 209 (see claim 14 and supporting text)(instant claims 23-26, 28 and 29). WO 2016/087617 discloses those subtilase variants of SEQ ID NO:2 (instant SEQ ID NO:1) comprising a mutation at position 9 (S9E), Y104I, G128S and S204D (see claim 14 and supporting text)(instant claims 30).
While WO 2016/087617 do not necessarily teach that the taught subtilisin variants have increased storage stability in a detergent composition compared to the subtilase of SEQ ID NO:1, this is considered an inherent property of the taught subtilisins based upon the high degree of structural identity. WO 2016/087617 further teach detergent and cleaning compositions comprising the subtilisin mutants and methods of their use in cleaning methods.
Thus, claim(s) 1, 23, 24, 25, 26, 28, 29, 30, 32-34, 36-38 and 40 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2016/087617 (equivalent US 2017/0335307).
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, 23, 24, 25, 26, 28, 29, 30, 31, 32-34, 36-38 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/087617 (equivalent US 2017/0335307).
WO 2016/087617 discloses a number of subtilase variants and polynucleotides encoding them for use in cleaning and detergent compositions such as laundry detergent compositions and dish wash compositions. WO 2016/087617 discloses subtilase variants comprising a number of mutations in the subtilase of SEQ ID NO:2 which has 100% sequence identity to instant SEQ ID NO:1. WO 2016/087617 discloses those subtilase variants of SEQ ID NO:2 (instant SEQ ID NO:1) comprising a mutation at position 9 (S9E), 206, 209 and 216 (see claim 15 and supporting text)(instant claims 1 and 40). WO 2016/087617 discloses those subtilase variants of SEQ ID NO:2 (instant SEQ ID NO:1) comprising a mutation at position 9 (S9E), 206 and 209 (see claim 14 and supporting text)(instant claims 23-26, 28 and 29). WO 2016/087617 discloses those subtilase variants of SEQ ID NO:2 (instant SEQ ID NO:1) comprising a mutation at position 9 (S9E), Y104I, G128S and S204D (see claim 14 and supporting text)(instant claims 30).
While WO 2016/087617 do not necessarily teach that the taught subtilisin variants have increased storage stability in a detergent composition compared to the subtilase of SEQ ID NO:1, this is considered an inherent property of the taught subtilisins based upon the high degree of structural identity. WO 2016/087617 further teach detergent and cleaning compositions comprising the subtilisin mutants and methods of their use in cleaning methods.
One of skill in the art before the time of invention would have been motivated to use the subtilisin variants taught WO 2016/087617 (including a mutation at Ser 9, Gly128, Ser204 and Tyr104) with other mutant positions as a means of making subtilisin variants with improved cleaning properties for their use in cleaning/detergent compositions for cleaning/detergent methods. These additional mutant positions include any of the mutant positions listed by WO 2016/087617 and similar amino acid substitutions such as a valine for isoleucine at position Y104 because valine and isoleucine have similar hydrophilic side groups. Thus making obvious those subtilase variants of SEQ ID NO:2 (instant SEQ ID NO:1) comprising a mutation at position 9 (S9E), Y104V, G128S and S204D (see claim 14 and supporting text)(instant claim 31). The expectation of success is high based upon the high level of skill in the art in the area of recombinant protein engineering as illustrated by WO 2016/087617
Thus claim(s) 1, 23, 24, 25, 26, 28, 29, 30, 31, 32-34, 36-38 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/087617 (equivalent US 2017/0335307).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 23-26, 28-34, 36-38 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9 and 10 of U.S. Patent No. 12,188,064. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5, 9 and 10 of U.S. Patent No. 12,188,064. drawn to an subtilase variant, comprising mutations at three or more positions selected from position 9 and 209 in combination with two or more additional positions selected from the group consisting of positions 63, 215, and 217, wherein positions are numbered according to SEQ ID NO: 1, wherein the mutation at position 63 is S63G or S63A, the mutation at position 209 is L209W, the mutation at position 215 is G215A and the mutation at position 217 is Y217L, Y2171, Y217V or Y217M and wherein the variant has protease activity and a sequence identity to SEQ ID NO: 1 of at least 85% and less than 100%. anticipate/make obvious instant claims 1, 23-26, 28-34, 36-38 and 40 drawn to a subtilase variant, comprising mutations at three or more positions, selected from position 9 in combination with two or more additional positions selected from the group consisting of 63, 76, 88, 104, 107, 128, 131, 159, 204, 206, 209, 212, 215, 216, 261 and 262, wherein positions are numbered according to SEQ ID NO: 1, and wherein the variant has protease activity and a sequence identity to SEQ ID NO: 1 of at least [[80%]]85% and less than 100%.
Applicants have asked that the double patenting rejection be held in abeyance until there is otherwise indication of allowable subject matter.
Claims 1, 23-26, 28-34, 36-38 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 and 25 of U.S. Patent No. 10,683,491. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-24 and 25 of U.S. Patent No. 10,683,491, drawn to an subtilase variant, comprising the substitutions X9E+X206L+X262E, wherein (a) the positions correspond to the positions of the polypeptide of SEQ ID NO: 2; (b) the variant has protease activity; and (c) the variant has at least 90%, but less than 100%, sequence identity to the polypeptide of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11, further comprising one or more alterations selected from the group consisting of X3T, X4I, X15T, X24G, X24R, X27R, *36D, X43A, X43C, X43L, X43R, X43W, X68A, X72A, X72V, X78D, X87R, X87S, *97E, X98S, X99A, X99D, X99A, X99D, X99E, X99G, *99D, X101D, X101E, X101G, X101I, X101K, X101L, X101M, X101N, X101R, X103A, X104F, X104I, X104N, X104Y, X106A, X114V, X115T, X115W, X118R, X118V, X120D, X120I, X120N, X120T, X120V, X123S, X128A, X128L, X128S, X129D, X129N, X129Q, X130A, X147W, X149C, X149N, X158E, X160D, X160P, X161C, X161E, X162L, X163A, X163D, X167A, X170S, X182C, X182E, X185C, X185E, X188C, X188D, X188E, X191N, X194P, X195E, X199M, X204D, X204V, X205I, X209W, X212A, X212D, X212G, X212N, X216I, X216T, X216V, X217C, X217D, X217E, X217M, X217Q, X217Y, X218D, X218E, X218T, X222C, X222R, X222S, X225A, X232V, X235L, X236H, X245K, X245R, X252K, X255C, X255E, X256A, X256C, X256D, X256V, X256Y, X259D, X260E, X260P, X261C, X261E, X261F, X261L, X261M, X261V, X261W, X261Y, and X274A, wherein each position corresponds to the position of the polypeptide of SEQ ID NO: 2, anticipate/make obvious instant claims 1, 23-26, 28-34, 36-38 and 40 drawn to a subtilase variant, comprising mutations at three or more positions, selected from position 9 in combination with two or more additional positions selected from the group consisting of 63, 76, 88, 104, 107, 128, 131, 159, 204, 206, 209, 212, 215, 216, 261 and 262, wherein positions are numbered according to SEQ ID NO: 1, and wherein the variant has protease activity and a sequence identity to SEQ ID NO: 1 of at least [[80%]]85% and less than 100%.
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
2/24/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652