DETAILED ACTION
Status of the Application
Claims 1, 10, 18, 20-25, 32 are pending.
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, 18, 20, 23 as submitted in a communication filed on 8/7/2026 is acknowledged.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/7/2026 has been entered.
Applicant elected without traverse Group I, claims 1-8, 10-25, 31, drawn in part to a subtilisin variant and a composition comprising said variant, and the election of the combination of positions 39, 74 and 99, including the combination of substitutions 39E, 74D and 99R, in a communication filed on 5/8/2025. As previously indicated, in view of the election of the combination of substitutions 39E, 74D and 99R, the prior amendment of claim 10, which is limited to variants that include these three substitutions, and the fact that a variant of the polypeptide of SEQ ID NO: 1 having at least 90% sequence identity to the polypeptide of SEQ ID NO: 18 which comprises the substitutions that correspond to the substitutions S39E, N74D, and S99R in the polypeptide of SEQ ID NO: 85 is free of the prior art, claim 10 was rejoined for examination on the merits.
Claims 1, 10, 18, 20-25 and 32 are at issue and will be examined only to the extent they encompass the elected invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Terminal Disclaimer
The terminal disclaimer filed on 8/3/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,421,189, 11,946,081, 11,499,146, and 11,492,571 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 23 is objected to due to the recitation of “one or more calcium ion and/or zinc ion, one or more enzyme stabilizer…..one or more bleaching agent….one or more adjunct material….”. To be grammatically correct, the claim should be amended to recite “one or more calcium ions and/or zinc ions, one or more enzyme stabilizers…..one or more bleaching agents….one or more adjunct materials….”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
Claims 1, 10, 18, 20-25, 32 remain 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 pre-AIA the applicant regards as the invention. New grounds of rejection are necessitated by amendment.
Claim 1 (claims 10, 18, 20-25, 32 dependent thereon) is indefinite in the recitation of “and comprising amino acid substitutions at positions corresponding to positions in the polypeptide of SEQ ID NO: 85 of S039E-N74D-S099R….improved thermostability in detergent” for the following reasons. The term “amino acid substitutions at positions corresponding to positions in the polypeptide of SEQ ID NO: 85 of” implies that the following phrase refers to positions. However, the following term refers to substitutions (i.e., S039E, N074D, S099R). In addition, it is unclear if the substitutions recited are substitutions that correspond to substitutions in the polypeptide of SEQ ID NO: 85. Furthermore, it is totally unclear as to what is the meaning of the term “thermostability in detergent”. Does the term refer to stability of the subtilisin in a detergent composition? If the intended limitation is “having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 18, wherein said variant comprises substitutions that correspond to substitutions S039E, N74D and S99R in the polypeptide of SEQ ID NO: 85, wherein said variant has one or more improved properties compared to the subtilisin of SEQ ID NO: 85 selected from the group consisting of improved protease activity, improved cleaning activity, and improved thermostability”, the claim should be amended accordingly. Correction is required.
Claim 10 is indefinite in the recitation of “wherein said variant comprises an amino acid sequence comprising one or more amino acid substitutions selected from A037T-S039E-N074D-S099R-V102I, S126T….A037T….S158T-G160S-N242D” for the following reasons. The recitation of positions as they relate to substitutions is meaningless in the absence of the sequence identifier associated with those positions. In addition, the term “comprising one or more amino acid substitutions selected from” is unclear because the items to select from are not individual substitutions but rather combinations of substitutions. Each of these combinations of substitutions require the substitutions S039E-N074D-S099R. As such, even if the claim were to recite “comprising one or more combinations of substitutions selected from” it is unclear as to how one could have one or more of the combinations recited. For example, if a set comprises substitutions A-B-C-D and another set comprises substitutions X-B-C-Y, it is unclear as to how one could have a combination of substitutions A-B-C-D-X-B-C-Y (two times substitution B and two times substitution C). If the intended limitation is “wherein said variant comprises a combination of substitutions that correspond to substitutions in the polypeptide of SEQ ID NO: 85, wherein said combination is selected from the group consisting of A037T-S039E-N074D-S099R-V102I, S126T….; and A037T….S158T-G160S-N242D”, the claim should be amended accordingly. For examination purposes, claim 10 will be interpreted as a duplicate of claim 1. Correction is required.
Claim 18 is indefinite in the recitation of “wherein said variant has ..improved cleaning performance in detergent…improved thermostability in detergent…” for the following reasons. It is unclear as to what is the meaning of the terms “cleaning performance in detergent” and “thermostability in detergent”. Does the term “cleaning performance in detergent” refer to cleaning performance of a detergent that comprises the subtilisin? Does the term “thermostability in detergent” refer to the stability of the subtilisin in a detergent composition? For examination purposes, it will be assumed that the claim is a duplicate of claim 1 as interpreted above. Correction is required.
Claim 20 (claims 21-25 and 32 dependent thereon) is indefinite in the recitation of “comprising the isolated subtilisin variants of claim 1” for the following reasons. There is no antecedent basis for “variants”. . For examination purposes, it will be assumed that claim 20 is directed to a composition that comprises the isolated subtilisin variant of claim 1. Correction is required.
Claim 23 is indefinite in the recitation of “further comprises one or more calcium…one or more enzyme stabilizer; from 0.001% to about 1.0 weight% of said variant, …one or more additional enzymes selected from….serine proteases, and combinations thereof” for the following reasons. As written, it is unclear what should have a concentration from 0.001% to about 1.0 weight % of said variant. Please note that there is a semicolon between the term “stabilizer” and “from”. Furthermore, while the term “one or more additional enzymes selected from the group consisting of” encompasses any combination of the enzymes recited after the term “group consisting of”, it is unclear as to how the term “combinations thereof” further limit the claim. Does the term “thereof” refer to any of the elements recited in the claim that should be present in the composition, such as calcium ions, enzyme stabilizers, bleaching agents, and enzymes? If the term “thereof” refers solely to the enzymes recited, it is noted that the term “one or more additional enzymes selected from the group consisting of” encompasses any combination of the enzymes recited. For examination purposes, no patentable weight will be given to the terms “from 0.001% to about 1.0 weight% of said variant” and “combinations thereof”. Correction is required.
When amending the claims, applicant is advised to carefully review all examined claims and make the necessary changes to ensure proper antecedent basis and dependency.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
Claims 1, 10, 18, 20-25, 32 were 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 and enablement requirements. In view of the amendment of claim 1 which now requires the variant to have protease activity, these rejections are hereby withdrawn.
Double Patenting
Claims 1, 10, 18, 20-25, 32 were rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over (i) claims 1-19 of U.S. Patent No. 11,421,189 (common inventors Babe, Goedegebuur, and Pricelius; different assignee), (ii) claims 1-9 of U.S. Patent No. 11,946,081 (common inventors Babe, Goedegebuur, Mulder and Pricelius), (iii) claims 1-10 of U.S. Patent No. 11,499,146 (common inventors Babe, Bott, Estell, Yao, Scotcher, Goedegebuur, Mulder and Pricelius), and (iv) claims 1, 3 of U.S. Patent No. 11,492,571 (common inventors Babe, Goedegebuur, Mulder, and Pricelius).
In view of the timely submission of a terminal disclaimer, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,421,189, 11,946,081, 11,499,146, and 11,492,571, these rejections are hereby withdrawn.
Claims 1, 10, 18, 20-25, 32 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over (i) claims 1-14 of copending Application No. 18/720,046 (common inventors Babe, Goedegebuur, and Mulder), (ii) claims 1-14 of copending Application No. 17/613,224 (common inventors Babe, Goedegebuur, Mulder and Pricelius; now allowed), and (iii) claims 1-7, 9-14 of copending Application No. 18/065, 644 (common inventors Babe, Goedegebuur, and Mulder; different assignee).
Applicant states that these rejections are provisional and that no patent has issued from these applications. Applicant requests that consideration of these provisional rejections be deferred until the claims of the copending applications are allowed.
Applicant’s arguments have been fully considered. It is noted that copending Application No. 17/613,224 has been allowed and the issue fee paid. In view of the fact that no arguments have been filed traversing the Examiner’s position and no terminal disclaimer has been filed, these rejections are maintained.
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Conclusion
No claim is in condition for allowance.
Applicant is advised that any Internet email communication by the Examiner has to be authorized by Applicant in written form. See MPEP § 502.03 (II). Without a written authorization by Applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Sample written authorization language can be found in MPEP § 502.03 (II). An Authorization for Internet Communications in a Patent Application or Request to Withdraw Authorization for Internet Communications form (SB/439) can be found at https://www.uspto.gov/patent/forms/ forms-patent-applications-filed-or-after-september-16-2012, which can be electronically filed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. 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.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
August 11, 2026
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