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 8 and 17, amendment of claims 1-4 and 16 and the addition of new claims 18-19, in the paper of 11/25/2025, is acknowledged. Applicants' arguments filed on 11/25/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1-7, 9-16, 18-19 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of the invention of Group 1, claims 1-14, 16 and 17, to a fabric and home care composition comprising a surfactant and a protease, in the paper of 8/5/2025, is acknowledged. Applicant's election without traverse of the
following species : Species Group 1: S039E, S099R, S126A, D127E, and F128G, Species Group 2: M122L, Species Group 3: Each SEQ ID NO: 1, Species Group 4: S039E-N074D-S099R-M122L-S126A-D127E-F128G-N198A-M211Q-N212Q, Species Group 5: alpha amylase and Species Group 6: BspAmy24, in the paper of 8/5/2025, is acknowledged.
Claim 15 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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 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 1-7, 9-14, 16 and 18 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 1 (claims 2-7, 9-14, 16 and 18 dependent on) is indefinite in the recitation “at least about 88% identity” The term “at least” requires percentages equal to or greater than 88%, whereas the term “about” permits values lower than 88%. As such the metes and bounds of the claim are unclear because the percent identity being claimed is unclear.
Claims 1 (claims 2-7, 9-14, 16 and 18 dependent on) is indefinite in that it is confusing and unclear as to the exact required amino acid substitutions in the protease of the claimed composition. The basis of the indefiniteness is that applicants added recitation that “the subtilisin variant comprises the : N198A-M211Q-N212Q”, renders the recitation “comprises one or more additional substitutions selected from the group consisting of N74D, T114L, M122L, N198A, M211Q, N212Q, and N242D” meaning less in the context of the claim. Thus it is confusing and unclear and results in indefiniteness of the claim.
Claim 2 is further indefinite in that it recites substitutions that are not possible by virtue of its dependence on claim 1. Claim 2 recites a possible amino acid substitution of “M211E” which is not possible by virtue that claim 1 from which claim 2 depends requires a M211Q substitution.
Claim 2 is further indefinite in that it recites “wherein the positions correspond to the positions of the amino acid sequence of SEQ ID NO:1 or 2”, wherein claim 1 from which claim 2 depends recites that “the positions correspond to the positions of the amino acid sequence of SEQ ID NO:1.” The different reference sequence in claim 2 is indefinite.
Appropriate correction and/or comment is required.
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) 1-13, 16 and 17 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Babe et al. (WO 2018/118950; Published June 28, 2018; equivalent docs: US 2019/0330610; US 11,946,081) is withdrawn based upon applicants amendment of the claims and applicants arguments presented in the paper of 11/25/2025. Specifically while Babe et al. (WO 2018/118950) disclose fabric and home care compositions comprising a surfactant and a subtilisin protease variant comprising S039E, S099R, S126A, D127E, F128G and, M122L, wherein the subtilisin variant has greater than 95% sequence identity to instant SEQ ID NO:1 (see claim 7 and supporting text), they do not teach said subtilisin protease variant comprising N198A-M211Q-N212Q.
Claim(s) 1-7, 9-13 and 16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Souter et al. (US 11,492,571, US 2021/0122997).
Souter et al. (US 11,492,571) teaches Bacillus serine proteases and variants thereof and methods of use thereof. Souter et al. (US 11,492,571) disclose one or more subtilisin variant, nucleic acid encoding same, and compositions and methods related to the production and use thereof, including one or more subtilisin variant that has improved soil removal compared to one or more reference subtilisin. Souter et al. (US 11,492,571) disclose compositions containing the serine proteases are suitable for use in cleaning fabrics and hard surfaces, as well as in a variety of industrial applications (see abstract and background). Souter et al. (US 11,492,571) disclose fabric and home care compositions comprising a surfactant and a subtilisin protease variant comprising S039E, N074D, S099R, S126A, D127E, F128G, N198A, M211Q and N212Q, wherein the subtilisin variant has greater than 90% sequence identity to instant SEQ ID NO:1 (see claim 1 and supporting text). Souter et al. disclose that the subtilisin variant is derived from a parent which has greater than 60% sequence identity to instant SEQ ID NO:1 and has improved property such as cleaning performance in detergent and improved stability relative to instant SEQ ID NO:1 and instant SEQ ID NO:2. Souter et al. disclose that the composition may be used as an automatic dishwashing composition and comprising a bleaching system, such as Manganese 1,4,7-Triazacyclononane and an amylase.
Thus, claims 1-7, 9-13 and 16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Souter et al. (US 11,492,571, US 2021/0122997).
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 1-7, 9-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No.11,492,571). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 2 of U.S. Patent No.11,492,571) drawn to a phosphate-free automatic dishwashing cleaning composition comprising a protein comprising a protease wherein the protease has at least about 85% identity with the amino acid sequence of SEQ ID NO:1, and wherein the protease comprises the amino acid substitutions S039E-N074D-S099R-S126A-D127E-F128G-N198A-M211Q-N212Q anticipate/make obvious instant claims 1-7, 9-13 and 16 drawn to a fabric and home care composition comprising: a surfactant; and a protease, wherein the protease comprises a subtilisin variant having at least about 88% identity to the amino acid sequence of SEQ ID NO: 1, wherein the subtilisin variant comprises .
Claim 1-7, 9-14, 16, 18 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7-20 of copending Application No. 18/065,643 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3-5, 7-20 of copending Application No. 18/065,643 (reference application) drawn to a home care composition comprising a surfactant and amylase, wherein the amylase comprises a recombinant, non-naturally-occurring variant of a parent alpha-amylase, the variant alpha-amylase having at least about 80% identity to SEQ ID NO: 5 and having amino acid substitutions at positions 415 and/or 51 with respect to SEQ ID NO:5, wherein the one or more enzymes comprises a protease, wherein the protease is a subtilisin variant comprising three, four, or five amino acid substitutions selected from the group consisting of S039E, S099R, S126A, D127E, and F128G and further comprises one or more additional substitutions selected from the group consisting of N74D, T114L, M122L, N198A, N198G, M211E, M21IQ, N212Q, and N242D, and wherein the variant has at least 80% identity to the amino acid sequence of SEQ ID NO: 6 anticipate/make obvious instant claims 1-7, 9-14, 16 and 18 drawn to a fabric and home care composition comprising: a surfactant; and a protease, wherein the protease comprises a subtilisin variant having at least about 88% identity to the amino acid sequence of SEQ ID NO: 1, wherein the subtilisin variant comprises .
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/065,645 (reference application, now allowed). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12 of copending Application No. 18/065,645 (reference application, now allowed) drawn to an automatic dishwashing composition comprising a surfactant and a protease, wherein the automatic dishwashing composition is in the form of a water-soluble unit-dose pouch comprising a compartment, wherein the compartment comprises both a powder component and a gel component, wherein the protease comprises a subtilisin variant that comprises: (i) a mutation at position 122; and (ii) one or more mutations at positions 126, 127, 128, 211 and 212, with reference to SEQ ID NO: 1, and wherein the variant has at least about 80% identity to the amino acid sequence of SEQ ID NO: 1, wherein the variant comprises (i) the mutation at position M122L; and (ii) one or more mutations at positions 126, 127, 128, 211 and 212 anticipate/make obvious instant claims 1-13, drawn to a fabric and home care composition comprising: a surfactant; and a protease, wherein the protease comprises a subtilisin variant having at least about 88% identity to the amino acid sequence of SEQ ID NO: 1, wherein the subtilisin variant comprises three, four, or five amino acid substitutions selected from the group consisting of S039E, S099R, S126A, D127E, and F128G and further comprises one or more additional substitutions selected from the group consisting of N74D, T114L, M122L, N198A, M211Q, N212Q, and N242D, wherein the positions correspond to the positions of the amino acid sequence of SEQ ID NO: 1, and wherein the subtilisin variant comprises the substitutions: N198A-M211Q-N212Q.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 on 6-3 EST Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (571) 272-0956. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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rgh
1/14/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652