DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 January 2026 has been entered.
Status of Application
The petition to establish a joint research agreement, filed 22 January 2026 is acknowledged and was accepted by the Office of Petitions on 20 May 2026.
The response and TD filed 22 January 2026 are acknowledged and have been considered in their entireties. The TD has been accepted (see below).
Claims 1, 4-10, 13-14 and 16-22 remain pending; Claims 18-22 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1, 4-10, 13-14 and 16-17 remain subject to examination on the merits.
Terminal Disclaimer
The terminal disclaimer filed on 22 January 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patents 10,287,534 and 10,844,328 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawal of Previous Objections/Rejections
The objection to the specification for lack of a compliant incorporation by reference to a sequence listing is withdrawn in view of the amendments to the specification filed 22 January 2026.
The rejection of claim(s) 1, 4-10, 13-14 and 16-17 under 35 U.S.C. 102(a)(2) as being anticipated by Damager et al. (WO 2017097866 – cited herein, with an effectively filed date of 07 December 2015) is withdrawn in view of the 35 U.S.C. 102(b)(2)(C) statement filed 22 January 2026 (See Remarks, p. 6).
The rejection of claim(s) 1, 4-10, 13-14 and 16 under 35 U.S.C. 102(a)(2) as being anticipated by Regueira et al. (US 11407986 – cited herein, with an effectively filed date of 30 December 2015) is withdrawn in view of the 35 U.S.C. 102(b)(2)(C) statement filed 22 January 2026 (See Remarks, pp. 6-7).
The rejection of claims 1, 4-10, 13-14 and 16 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10287534 is withdrawn in view of the JRA TD filed 22 January 2026.
The rejection of claims 1, 4-10, 13-14 and 16 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10844328 is withdrawn in view of the JRA TD filed 22 January 2026
Claim Interpretation
SEQ ID NO: 1 and SEQ ID NO: 2 have 97.1% identity to one another. It is noted, SEQ ID NO: 2 has a two amino acid insertion relative to SEQ ID NO: 1 at positions 182-183. Thus, the numbering between SEQ ID NO: 1 and 2 are identical from amino acids 1-181; and differ by two from 182-483 (SEQ ID NO: 1) and 182-485 (SEQ ID NO: 2). That is, position 184 in SEQ ID NO: 1, is position 186 when using SEQ ID NO: 2 numbering. Positions 200 and 244 in SEQ ID NO: 1 is position 202 and 246 when using SEQ ID NO: 2 numbering.
RESULT 1
US-16-097-743B-2
Query Match 97.1%; Score 2609; DB 1; Length 485;
Best Local Similarity 96.5%;
Matches 468; Conservative 7; Mismatches 8; Indels 2; Gaps 1;
Qy 1 HHNGTNGTLMQYFEWYLPNDGNHWNRLRSDASNLKDKGISAVWIPPAWKGASQNDVGYGA 60
||||||||:|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 HHNGTNGTMMQYFEWYLPNDGNHWNRLRSDASNLKDKGISAVWIPPAWKGASQNDVGYGA 60
Qy 61 YDLYDLGEFNQKGTIRTKYGTRNQLQAAVNALKSNGIQVYGDVVMNHKGGADATEMVKAV 120
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||:||
Db 61 YDLYDLGEFNQKGTIRTKYGTRNQLQAAVNALKSNGIQVYGDVVMNHKGGADATEMVRAV 120
Qy 121 EVNPNNRNQEVSGEYTIEAWTKFDFPGRANTHSNFKWRWYHFDGVDWDQSRKLNNRIYKF 180
|||||||||||||||||||||||||||| |||||||||||||||||||||||||||||||
Db 121 EVNPNNRNQEVSGEYTIEAWTKFDFPGRGNTHSNFKWRWYHFDGVDWDQSRKLNNRIYKF 180
Qy 181 R--TKAWDWEVDTEFGNYDYLLYADIDMDHPEVVNELRNWGVWYTNTLGLDGFRIDAVKH 238
| | |||||||| ||||||:||||||||||||||||||||||||||||||||||||||
Db 181 RGDGKGWDWEVDTENGNYDYLMYADIDMDHPEVVNELRNWGVWYTNTLGLDGFRIDAVKH 240
Qy 239 IKYSFTRDWINHVRSAIGKNMFAVAEFWKNDLGAIENYLNKTNWNHSVFDVPLHFNLYYA 298
|||||||||||||||| |||||||||||||||||||||||||||||||||||||:||| |
Db 241 IKYSFTRDWINHVRSATGKNMFAVAEFWKNDLGAIENYLNKTNWNHSVFDVPLHYNLYNA 300
Qy 299 SKSGGNYDMRQIFNGTVVQKHPTHAVTFVDNHDSQPEESLESFVREWFKPLAYALTLTRE 358
|||||||||||||||||||:|| |||||||||||||||:||||| |||||||||||||||
Db 301 SKSGGNYDMRQIFNGTVVQRHPMHAVTFVDNHDSQPEEALESFVEEWFKPLAYALTLTRE 360
Qy 359 QGYPSVFYGDYYGIPTHGVPAMKSKIDPILEARQKYAYGRQNDYLDHHNIIGWTREGNTA 418
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 QGYPSVFYGDYYGIPTHGVPAMKSKIDPILEARQKYAYGRQNDYLDHHNIIGWTREGNTA 420
Qy 419 HPNSGLATIMSDGAGGNKWMFVGRNKAGQVWTDITGNKAGTVTINADGWGNFSVNGGSVS 478
|||||||||||||||||||||||||||||||||||||:||||||||||||||||||||||
Db 421 HPNSGLATIMSDGAGGNKWMFVGRNKAGQVWTDITGNRAGTVTINADGWGNFSVNGGSVS 480
Qy 479 IWVNK 483
|||||
Db 481 IWVNK 485
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 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.
Claims 1, 4-10, 13-14 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11407986. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims to the ‘986 patent render obvious the instant claims.
The instant claims in their broadest are drawn to a polypeptide comprising a variant amino acid sequence of SEQ ID NO: 1, wherein the polypeptide has alpha-amylase activity and exhibits an improved wash performance compared to the parent polypeptide of SEQ ID NO: 1, said variant amino acid sequence comprises a mutation in the amino acid sequence of SEQ ID NO: 1, using the number of the amino acid sequence of SEQ ID NO: 2 corresponding to positions L202M and T246(L/V) , and has at least 80% sequence identity to SEQ ID NOs: 1.
The claims to the ‘986 patent in their broadest are drawn to A polypeptide comprising a variant amino acid sequence of SEQ ID NO: 1, wherein the polypeptide comprises: (a) a substitution with Y or H at a position corresponding to amino acid position 167, wherein numbering is according to the amino acid sequence set forth in SEQ ID NO: 2; and (b) a mutation at one or more positions corresponding to positions 48, 210, 299, 339, or 366, wherein numbering is according to the amino acid sequence set forth in SEQ ID NO: 2; wherein the polypeptide has at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 1, and wherein the polypeptide has alpha-amylase activity and exhibits an enhanced wash performance compared to the polypeptide of SEQ ID NO: 1. Dependent claims recite additional substitutions at one or more positions including 202 and 246 (claim 8), and specifically position T246(V/I/L) (claim 10) and those including L202M (claim 11).
It is noted, instant SEQ ID NO: 1 and the SEQ ID NO: 1 of the ‘986 patent have 100% sequence identity to one another (see Supplemental Content, 20240616_184535_us-16-097-743b-1.rai file, Result #1).
Thus, the claims of the ‘986 patent are deemed to render obvious the instant claims because clearly the one or more positions as in claim 8 including 202 and 246 are meant to include the preferred substitutions of L202M and T246(L/I/V) as stipulated in claims 10 and 11, for example.
Claims 1, 4-10, 13-14 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11859221. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims to the ‘221 patent anticipate the instant claims.
The instant claims in their broadest are drawn to a polypeptide comprising a variant amino acid sequence of SEQ ID NO: 1, wherein the polypeptide has alpha-amylase activity and exhibits an improved wash performance compared to the parent polypeptide of SEQ ID NO: 1, said variant amino acid sequence comprises a mutation in the amino acid sequence of SEQ ID NO: 1, using the number of the amino acid sequence of SEQ ID NO: 2 corresponding to positions L202M and T246(L/V) , and has at least 80% sequence identity to SEQ ID NOs: 1.
The claims to the ‘221 patent in their broadest are drawn to A polypeptide comprising a variant amino acid sequence of SEQ ID NO: 1, wherein the polypeptide has alpha-amylase activity, has at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 1, comprises a mutation corresponding to position 339 wherein numbering is according to the amino acid sequence set forth in SEQ ID NO: 2, and exhibits an enhanced wash performance compared to the polypeptide of SEQ ID NO: 1. Dependent claims recite additional substitutions at one or more positions including positions L202M and T246(L/I/V) (claim 8).
Specific mutations taught include: A51T+L202M; L202M+T246I; L202+T246I+S334T; A51T+L202+T246I+S334T; A51T+L202M+T246I; A186D+L202M; A186D+L202M+N270G+S339A+N402Y; A186N+L202M+T246V+N270G+S334T; A51T+L202M+T246L+N270G (See Claim 9).
It is noted, instant SEQ ID NO: 1 and the SEQ ID NO: 1 of the ‘986 patent have 100% sequence identity to one another (see Supplemental Content, 20240616_184535_us-16-097-743b-1.rai file, Duplicates for Result #1).
Thus, the claims of the ‘221 patent are deemed to anticipate the instant claims.
Applicant’s Response
Applicant’s acknowledge the instant rejections above (it is noted, however, Applicant’s refer to the rejection over US Patent 11859211, rather than the US Patent cited above, which is US 11859221, see p. 7, part IV) and ask these rejections be held in abeyance until such time has been identified.
The Examiner acknowledges this response and notes these are the only rejections of record remaining. The rejections are maintained.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 26 May 2026
Prosecution Insights