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 .
DETAILED ACTION
This application is a divisional of 17/489,288, which is a divisional of 15/579,321, issued as US Patent 11,162,089, which is a 371 of PCT/EP2016/063715.
The amendment filed on October 1, 2025 has been entered.
Election/Restrictions
Applicant elected with traverse of Group I with a species election of SEQ ID NO:1 as the parent subtilase and *99aE + X209W + one or more additional modifications selected from X21D, X59D, X101H, X120D, X156D, X163G, X194P, X195E, X238E, X256D, X261D, and X262E as the amino acid modifications made in said parent subtilase in the reply filed on September 24, 2024.
Claims 2, 4-7, 9, 11, and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 9, 2022.
The elected species, variant subtilase of SEQ ID NO:1, wherein the variant subtilase consists of the *99aE+x209w+X262E amino acid alterations, *99aE+A194P, *99aE+S163G+G195E+N261D, or N76D+ *99aE+A194P are disclosed in the prior art. See the rejections under 35 U.S.C. 102 in the Office Action mailed on April 1, 2025. In the amendment filed on October 1, 2025, claim 1 was amended to require *99aE and X156D and at least two additional amino acid substitutions recited in claim 1, which overcomes said ejections under 35 U.S.C. 102. Therefore, search and examination was extended to a subsequence species, *99aE+S156D+Y209W+L262E, which is free of the prior art. Therefore, search and examination has been extended to *99aE+S156D and H120D + A194P +G195E + N261D + L262E and S3T, which is disclosed in the prior art, see the 102 rejection below. Therefore, examination has not been extended to any other subsequent species.
Status of Claims
Claims 1, 8, 10-14, and 18-22 are pending.
Claims 11, and 14 are withdrawn.
Claims 1, 8, 10, 12-13, and 18-22 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 25, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendments/Arguments
Claim Objections
Applicant’s arguments, see Section I at page 1 of the Remarks, filed October 1, 2025, with respect to claim 12 have been fully considered and are persuasive. Claim 12 has been amended to expand the entire phrase of “AMSA”. Therefore, the objection of claim 12 has been withdrawn.
Claim Rejections - 35 USC § 112(b)
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.
Withdrawn Rejection
Applicant’s arguments, see Section II at page 1 of the Remarks, filed October 1, 2025, with respect to claim 1 have been fully considered and are persuasive. Claim 1 has been amended to delete the broad range and narrow range. Therefore, the rejection of claim 1 and claims 3, 8, 10, 12, 13, and 15-16 depending therefrom under 35 U.S.C. 112(b) has been withdrawn.
New Rejection
Claim 10 is 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.
Claim 10 recites the limitation "the set of alterations" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 10 depends from claim 10 and claim 10 does not recite a “set of alteration”. Therefore, it is unclear if the alterations refers to the amino acid substitutions recited in claim 1 or refers to other alterations. Clarification is requested.
Claim Rejections - 35 USC § 112(d)
Applicant’s arguments, see Section III at page 2 of the Remarks, filed October 1, 2025, with respect to claim 8 have been fully considered and are persuasive. Therefore, the rejection of claim 8 under 35 U.S.C. 112(b) has been withdrawn.
Claim Rejections - 35 USC § 112(a)
Applicant's arguments, see Section IV at page 2 of the Remarks, filed October 1, 2025, with respect to claims 1, 3, 8, 10, 12-13, and 15-16 have been fully considered and are persuasive. Claim 1 has been amended to recite that the subtilase variant has at least 80% but less than 100% sequence identity to SEQ ID NO:1. Claims 3 and 15-16 have been cancelled. Applicant' s argument that the specification provides numerous examples to support the claimed genus has been found persuasive. Therefore, the rejection of claims 1, 3, 8, 10, 12-13, and 15-16 under 35 U.S.C. 112(a) for lack of written description has been withdrawn.
Applicant's arguments, see Section V at page 2 of the Remarks, filed October 1, 2025, with respect to claims 1, 3, 8, 10, 12-13, and 15-16 have been fully considered and are persuasive. Claim 1 has been amended to recite that the subtilase variant has at least 80% but less than 100% sequence identity to SEQ ID NO:1. Claims 3 and 15-16 have been cancelled. Applicant' s argument that the specification provides guidance to make the claimed polynucleotides without undue experimentation has been found persuasive. Therefore, the rejection of claims 1, 3, 8, 10, 12-13, and 15-16 under 35 U.S.C. 112(a) for lack enablement has been withdrawn.
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.
Withdrawn Rejections
Applicant's arguments, see Section VI at page 3 of the Remarks, filed October 1, 2025, with respect to claims 1, 3, 8, 10, 12-13, and 15-20 have been fully considered and are persuasive. Claim 1 has been amended to recite that the subtilase variant comprises X156D in addition to *99aE and two or more additional substitutions reacted in claim 1. Claims 3 and 15-16 have been cancelled. Toscano does not teach or suggest a subtilase variant having *99aE + X156D and two or more additional substitutions reacted in claim 1. Therefore, the rejection of claims 1, 3, 8, 10, 12-13, and 15-20 under 35 U.S.C. 102(a)(2) as being anticipated by Toscano (US 2017/0335307- form PTO-892, US 10,683,491– form PTO-892 or US 11,591,585– form PTO-892) has been withdrawn.
Applicant's arguments, see Section VII at page 3 of the Remarks, filed October 1, 2025, with respect to claims 1, 3, 8, 10, 12-13, and 15-20 have been fully considered and are persuasive. Claim 1 has been amended to recite that the subtilase variant comprises X156D in addition to *99aE and two or more additional substitutions reacted in claim 1. Claims 3 and 15-16 have been cancelled. Rasmussen does not teach or suggest a subtilase variant having *99aE + X156D and two or more additional substitutions reacted in claim 1. Therefore, the rejection of claims 1, 3, 8, 10, 12-13, and 15-20 under 35 U.S.C. 102(a)(2) as being anticipated by Rasmussen (US 2017/0137798 – form PTO-1449, US 10,550,381– form PTO-1449, US 11,015,183 – form PTO-1449, or US 2022/0064620 – form PTO-892) has been withdrawn.
Applicant's arguments, see Section VIII at page 4 of the Remarks, filed October 1, 2025, with respect to claims 1, 3, 8, 10, 12-13, and 15-20 have been fully considered and are persuasive. Claim 1 has been amended to recite that the subtilase variant comprises X156D in addition to *99aE and two or more additional substitutions reacted in claim 1. Claims 3 and 15-16 have been cancelled. Rasmussen does not teach or suggest a subtilase variant having *99aE + X156D and two or more additional substitutions reacted in claim 1. Therefore, the rejection of claims 1, 3, 8, 10, 12-13, and 15-20 under 35 U.S.C. 102(a)(2) as being anticipated by Rasmussen (US 2017/0145400– form PTO-892, US 10,626,388– form PTO-892, US 10,920,209 – form PTO-892, US 11,591,586, US 12,065,680– form PTO-892, or US 2024/0425836 – form PTO-8922) has been withdrawn.
Applicant's arguments, see Section IX at page 4 of the Remarks, filed October 1, 2025, with respect to claims 1, 3, 8, 10, 12-13, and 15-20 have been fully considered and are persuasive. Claim 1 has been amended to recite that the subtilase variant comprises X156D in addition to *99aE and two or more additional substitutions reacted in claim 1. Claims 3 and 15-16 have been cancelled. Mikkelsen does not teach or suggest a subtilase variant having *99aE + X156D and two or more additional substitutions reacted in claim 1. Therefore, the rejection of claims 1, 3, 8, 10, 12-13, and 15-20 under 35 U.S.C. 102(a)(1) as being anticipated by Mikkelsen (US 8,329,632 –form PTO-1449 and evidenced by Siezen (Homology modelling and protein engineering strategy of subtilases, the family of subtilisin-like serine proteinases, Protein Engineering, Design and Selection, Volume 4, Issue 7, October 1991, Pages 719–737 – form PTO-1449) has been withdrawn.
Applicant's arguments, see Section X at pages 4-5 of the Remarks, filed October 1, 2025, with respect to claims 1, 3, 8, 10, 12-13, and 15-20 have been fully considered and are persuasive. Claim 1 has been amended to recite that the subtilase variant comprises X156D in addition to *99aE and two or more additional substitutions reacted in claim 1. Claims 3 and 15-16 have been cancelled. Draborg does not teach or suggest a subtilase variant having *99aE + X156D and two or more additional substitutions reacted in claim 1. Therefore, the rejection of claims 1, 3, 8, 10, 12-13, and 15-20 under 35 U.S.C. 102(a)(1) as being anticipated by Draborg (US 2004/0147008– form PTO-1449 or US Patent No. 7,888,093 – form PTO-892) has been withdrawn.
New Rejection
Claim(s) 1, 8, 10, 12-13, and 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Baltsen (WO 2015/185689- form PTO-892).
Baltsen discloses subtilisin variants of the subtilisin 309 of SEQ ID NO:7, which has 100% sequence identity to the subtilisin 309 of SEQ ID NO:1 of the instant application (page 14, lines 7-35 and see the sequence alignment below). Baltsen discloses subtilisin BPN’ of SEQ ID NO:8, which has 100% sequence identity to the subtilisin BPN’ of SEQ ID NO:2 of the instant application (page 14, lines 7-35 and see the sequence alignment below).
Regarding clams 1 and 8, Baltsen discloses a subtilase variant comprising *99aE+S156D and H120D + A194P +G195E + N261D + L262E and S3T amino acid alterations (page 14, lines 7-35), wherein (i) the positions correspond to the positions of subtilase BPN’ of SEQ ID NO:2 of the instant application or SEQ ID NO:8 of Baltsen (page 14, line 26), (ii) the variant has protease activity, and (iii) the variant has as at least 80% but less than 100% sequence identity to SEQ ID NO:1 of the instant application.
Regarding claim 10, the above subtilisin variant of Baltsen is a variant of subtilisin 309 (page 14, lines 7-35).
Regarding claim 12, the above subtilisin variant of Baltsen has improved wash performance compared to SEQ ID NO: 1 (page 6, lines 25-29).
Regarding claim 13, the above subtilisin variant of Baltsen has between 4 and 30 amino acid alterations.
Regarding claims 18-20, the above subtiliase variant of Baltsen has at least 85-95% sequence identity to SEQ ID NO :1 of the instant application.
Therefore, the reference of Baltsen anticipates claims 1, 3, 8, 10, 12-13, and 18-20.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Double Patenting
Applicant's arguments, see Section XI at page 5 of the Remarks, filed October 1, 2025, with respect to claims 1, 3, 8, 10, 12-13, and 15-20 have been fully considered and are persuasive. Claim 1 has been amended to recite that the subtilase variant comprises X156D in addition to *99aE and two or more additional substitutions reacted in claim 1. Claims 3 and 15-16 have been cancelled. None of the claims of U.S. Patent No. 8,329,632, U.S. Patent No. 10,683,491, and U.S. Patent No. 11,591,585 recite a subtilase variant comprises X156D in addition to *99aE and two or more additional substitutions reacted in claim 1. Therefore, all previously nonstatutory double patenting rejections have been withdrawn.
Conclusion
Claims 1, 8, 10-14, and 18-22 are pending.
Claims 11, and 14 are withdrawn.
Claims 1, 8, 10, 12-13, and 18-20 are rejected.
Claims 21-22 are allowed.
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 YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YONG D PAK/Primary Examiner, Art Unit 1652
Sequence alignment between the Bacillus lentus subtilisin 309 of SEQ ID NO:1 of the instant application (“Qy”) and subtilisin 309 of SEQ ID NO:7 of Balsten (“Db”)
BCJ65158
ID BCJ65158 standard; protein; 269 AA.
XX
AC BCJ65158;
XX
DT 28-JAN-2016 (first entry)
XX
DE Bacillus lentus (subtilisin 309) protease protein SEQ ID NO: 7.
XX
KW Protease; biofilm; cell culture; prophylactic to disease; surfactant;
KW textile.
XX
OS Bacillus lentus.
XX
CC PN WO2015185689-A1.
XX
CC PD 10-DEC-2015.
XX
CC PF 04-JUN-2015; 2015WO-EP062502.
XX
PR 04-JUN-2014; 2014EP-00171164.
XX
CC PA (NOVO ) NOVOZYMES AS.
XX
CC PI Baltsen LET, Schnorr KM, Gori K, Skov LKOE;
XX
DR WPI; 2015-78199D/04.
XX
CC PT Use of a polypeptide having endo-beta-1,6-galactanase activity for
CC PT preventing, reducing or removing a biofilm from an item, where the item
CC PT is a textile, a dishware or a hard surface.
XX
CC PS Example 5; SEQ ID NO 7; 111pp; English.
XX
CC The invention relates to a novel detergent composition. The invention
CC claims: a) a detergent composition comprising a polypeptide having endo-
CC beta-1, 6-galactanase activity and a detergent adjunct ingredient; b) a
CC washing method for washing an item; c) a nucleic acid construct or
CC expression vector; d) a recombinant host cell; e) a method of producing a
CC polypeptide having endo-beta-1, 6-galactanase activity; and f) a whole
CC broth formulation or cell culture composition comprising a polypeptide.
CC The polypeptide having endo-beta-1, 6-galactanase activity is useful for
CC preventing, reducing or removing a biofilm from an item, where the item
CC is a textile, a dishware or a hard surface, and for maintaining or
CC improving whiteness of the item; and for producing a detergent
CC composition. The polypeptide produces a detergent composition which can
CC effectively prevent, reduce or remove sweat stains, adhered
CC microorganisms or biofilm from textile, dishware or hard surfaces. The
CC present sequence represents a Bacillus lentus (subtilisin 309) protease
CC protein used in the preventing, reducing or removing a biofilm from an
CC item in the invention.
XX
SQ Sequence 269 AA;
Query Match 100.0%; Score 1361; Length 269;
Best Local Similarity 100.0%;
Matches 269; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AQSVPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLNIRGGASFVPGEPSTQDGN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AQSVPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLNIRGGASFVPGEPSTQDGN 60
Qy 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGASGSGSVSSIAQGLEWAGNNGMHVA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGASGSGSVSSIAQGLEWAGNNGMHVA 120
Qy 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGAGSISYPARYANAMAVGATDQNNNR 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGAGSISYPARYANAMAVGATDQNNNR 180
Qy 181 ASFSQYGAGLDIVAPGVNVQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 ASFSQYGAGLDIVAPGVNVQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
Qy 241 RNHLKNTATSLGSTNLYGSGLVNAEAATR 269
|||||||||||||||||||||||||||||
Db 241 RNHLKNTATSLGSTNLYGSGLVNAEAATR 269
Sequence alignment between the subtilisin BPN’ of SEQ ID NO:2 of the instant application (“Qy”) and subtilisin BPN’ of SEQ ID NO:8 of Balsten (“Db”)
BCJ65159
ID BCJ65159 standard; protein; 275 AA.
XX
AC BCJ65159;
XX
DT 28-JAN-2016 (first entry)
XX
DE Bacillus amyloliquefacien (subtilisin BPN) protease protein SEQ ID NO: 8.
XX
KW Protease; biofilm; cell culture; prophylactic to disease; surfactant;
KW textile.
XX
OS Bacillus amyloliquefaciens.
XX
CC PN WO2015185689-A1.
XX
CC PD 10-DEC-2015.
XX
CC PF 04-JUN-2015; 2015WO-EP062502.
XX
PR 04-JUN-2014; 2014EP-00171164.
XX
CC PA (NOVO ) NOVOZYMES AS.
XX
CC PI Baltsen LET, Schnorr KM, Gori K, Skov LKOE;
XX
DR WPI; 2015-78199D/04.
XX
CC PT Use of a polypeptide having endo-beta-1,6-galactanase activity for
CC PT preventing, reducing or removing a biofilm from an item, where the item
CC PT is a textile, a dishware or a hard surface.
XX
CC PS Disclosure; SEQ ID NO 8; 111pp; English.
XX
CC The invention relates to a novel detergent composition. The invention
CC claims: a) a detergent composition comprising a polypeptide having endo-
CC beta-1, 6-galactanase activity and a detergent adjunct ingredient; b) a
CC washing method for washing an item; c) a nucleic acid construct or
CC expression vector; d) a recombinant host cell; e) a method of producing a
CC polypeptide having endo-beta-1, 6-galactanase activity; and f) a whole
CC broth formulation or cell culture composition comprising a polypeptide.
CC The polypeptide having endo-beta-1, 6-galactanase activity is useful for
CC preventing, reducing or removing a biofilm from an item, where the item
CC is a textile, a dishware or a hard surface, and for maintaining or
CC improving whiteness of the item; and for producing a detergent
CC composition. The polypeptide produces a detergent composition which can
CC effectively prevent, reduce or remove sweat stains, adhered
CC microorganisms or biofilm from textile, dishware or hard surfaces. The
CC present sequence represents a Bacillus amyloliquefacien (subtilisin BPN)
CC protease protein used in the preventing, reducing or removing a biofilm
CC from an item in the invention.
XX
SQ Sequence 275 AA;
Query Match 100.0%; Score 1391; Length 275;
Best Local Similarity 100.0%;
Matches 275; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AQSVPYGVSQIKAPALHSQGYTGSNVKVAVIDSGIDSSHPDLKVAGGASMVPSETNPFQD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AQSVPYGVSQIKAPALHSQGYTGSNVKVAVIDSGIDSSHPDLKVAGGASMVPSETNPFQD 60
Qy 61 NNSHGTHVAGTVAALNNSIGVLGVAPSASLYAVKVLGADGSGQYSWIINGIEWAIA NNMD 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NNSHGTHVAGTVAALNNSIGVLGVAPSASLYAVKVLGADGSGQYSWIINGIEWAIA NNMD 120
Qy 121 VINMSLGGPSGSAALKAAVDKAVASGVVVVAAAGNEGTSGSSSTVGYPGKYPSVIAVGAV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VINMSLGGPSGSAALKAAVDKAVASGVVVVAAAGNEGTSGSSSTVGYPGKYPSVIAVGAV 180
Qy 181 DSSNQRASFSSVGPELDVMAPGVSIQSTLPGNKYGAYNGTSMASPHVAGAAALILSKHPN 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 DSSNQRASFSSVGPELDVMAPGVSIQSTLPGNKYGAYNGTSMASPHVAGAAALILSKHPN 240
Qy 241 WTNTQVRSSLENTTTKLGDSFYYGKGLINVQAAAQ 275
|||||||||||||||||||||||||||||||||||
Db 241 WTNTQVRSSLENTTTKLGDSFYYGKGLINVQAAAQ 275