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
Application status
In response to the previous Office action, a non-Final rejection (mailed on 12/19/2025), Applicants filed a response and amendment received on 06/19/2026. Said amendment canceled Claim 15, amended Claims 1-2, and added Claims 18-19. Thus, Claims 1-14 and 18-19 are at issue and present for examination.
It is noted by the Examiner that Claims 16-17 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a non-elected invention in the previous Office actions, a non-Final rejection (mailed on 12/19/2025).
Objections to the Specification – WITHDRAWN
The previous objection for reciting an embedded hyperlink is withdrawn by virtue of Applicants’ amendment.
Claim Rejections - 35 U.S.C. § 112 – WITHDRAWN
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 previous rejection of Claims 1-14 under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention, is withdrawn.
The previous rejection of Claims 1 and 2 (3-14 dependent therefrom) for the recitation of “preferably” is withdrawn by virtue of Applicants’ amendment.
The previous rejection of Claims 4 and 9 for the recitation of “P131*” is withdrawn because the definition of what it means is clear, i.e., deletion, based on Applicants’ disclosure.
The previous rejection of Claim 11 for the recitation of “L262” is withdrawn by virtue of Applicants’ amendment.
Claim Rejections - 35 U.S.C. § 102 – WITHDRAWN
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 previous rejection of Claims 1-2, 4-5, 7 and 10-14 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by O’Connell et al. (Patent Application Publication No. 2017/349861, see IDS) is withdrawn by virtue of Applicants’ amendment.
Claim Rejections - 35 U.S.C. § 103 – MAINTAINED as necessitated by Applicants’ amendment
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.
The previous rejection of Claim 1-2, 4-5, 7, 10-14 and 18-19 under 35 U.S.C. 103 as being unpatentable over O’Connell et al. (Patent Application Publication No. 2017/349861, see IDS) in view of Amin et al. (WO2012151534-A1, see sequence search result 2 of 20251215_114627_us-17-927-164-1subs99en42rl256e.minpct80.rag available in SCV, which has been copied/pasted below for Applicants’ convenience) is maintained.
Instant claims are drawn to a subtilase variant of the polypeptide of SEQ ID NO: 1 comprising the substitution S101E/D, and N43R and at least one of the substitutions N76D, Q206L, Y209W and L262E, wherein the variant has protease activity and has at least 80% but less than 100% sequence identity to SEQ ID NO: 1, and wherein position numbers are based on the numbering of SEQ ID NO: 2.
O’Connell et al. teach a subtilase variant comprising substitutions N76D+S101E+A228V+L262E in SEQ ID NO:3 which has 98.7% sequence identity to Applicants’ SEQ ID NO: 1 (see para [0094], and below sequence alignment to Applicants’ SEQ ID NO: 1), optionally N43D/E, S156D, A194P, V205I and/or Y209W substitutions (see para [0010], [0081] and [0087]). O’Connell et al. further teach that said subtilase variant is comprised in a detergent composition having improved stability and/or improve wash performance in liquid detergent (see para [0082]).
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 1343 98.7 269 1 AASEQ2_07102025_115236
ALIGNMENTS
RESULT 1
AASEQ2_07102025_115236
Query Match 98.7%; Score 1343; DB 1; Length 269;
Best Local Similarity 98.1%;
Matches 264; Conservative 2; Mismatches 3; Indels 0; Gaps 0;
Qy 1 AQSVPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLNIRGGASFVPGEPSTQDGN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AQSVPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLNIRGGASFVPGEPSTQDGN 60
Qy 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGASGSGSVSSIAQGLEWAGNNGMHVA 120
|||||||||||||||||||||||||||||||||||| | |::||||||||||||||||||
Db 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGADGEGAISSIAQGLEWAGNNGMHVA 120
Qy 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGAGSISYPARYANAMAVGATDQNNNR 180
|||||||||||||||||||||||||||||||||||| |||||||||||||||||||||||
Db 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGASSISYPARYANAMAVGATDQNNNR 180
Qy 181 ASFSQYGAGLDIVAPGVNVQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 ASFSQYGAGLDIVAPGVNVQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
Qy 241 RNHLKNTATSLGSTNLYGSGLVNAEAATR 269
|||||||||||||||||||||||||||||
Db 241 RNHLKNTATSLGSTNLYGSGLVNAEAATR 269
Search completed: July 10, 2025, 11:52:37
Job time : 1 secs
O’Connell et al. do not teach N43R substitution based on the numbering of SEQ ID NO: 2.
Amin et al. teach a subtilase variant having 99.2% sequence identity to SEQ ID NO: 1 which has N43R substitution (which is identical to N42R in Bacillus lentus) according to the numbering of SEQ ID NO: 2.
RESULT 2
BAG75746
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID BAG75746 standard; protein; 269 AA.
XX
AC BAG75746;
XX
DT 17-JAN-2013 (first entry)
XX
DE Bacillus lentus subtilisin GG36 protease variant protein #3799.
XX
KW mutein; protein engineering; protein production;
KW subtilisin GG36 protease protein; surfactant.
XX
OS Bacillus lentus.
OS Synthetic.
XX
CC PN WO2012151534-A1.
XX
CC PD 08-NOV-2012.
XX
CC PF 04-MAY-2012; 2012WO-US036608.
XX
PR 05-MAY-2011; 2011US-0482938P.
XX
CC PA (DASC ) DANISCO US INC.
CC PA (PROC ) PROCTER&GAMBLE CO.
XX
CC PI Amin NS, Augustyn K, Basler JR, Cascao-Pereira LG, Collier KD;
CC PI Concar EM, Estell DA, Kellis JT, Magennis EJ, Pisarchik A;
CC PI Poulose AJ, Souter PF, Ward GS, Yao J;
XX
DR WPI; 2012-P61600/76.
XX
CC PT New isolated subtilisin variant comprising specific amino acid sequence
CC PT having combination of amino acid substitutions at specific positions, for
CC PT used in cleaning surface e.g. dishware item, fabric item, laundry item,
CC PT personal care items.
XX
CC PS Example 2; Page; 441pp; English.
XX
CC The present invention relates to an isolated subtilisin variant (D1)
CC selected from 8 subtilisin variants, e.g. an isolated subtilisin variant
CC comprising specific amino acid sequence having a combination of amino
CC acid substitutions at specific positions. The invention further includes:
CC (1) an isolated nucleic acid (A1) comprising a polynucleotide sequence
CC that encodes the subtilisin variant (D1); (2) an expression vector (V1)
CC comprising the nucleic acid (A1); (3) a host cell comprising the
CC expression vector (V1); (4) a method of preparing the isolated subtilisin
CC variant (D1); (5) a composition (C1) comprising the subtilisin variant
CC (D1), where the composition is not a fabric and home care product; (6) a
CC method of cleaning (M1), involving contacting a surface or an item with
CC the cleaning composition (C1); and (7) a method of cleaning (M2) a
CC surface or an item, involving providing the cleaning composition (C1) and
CC a surface or an item in need of cleaning; and contacting the cleaning
CC composition with the surface or an item in need of cleaning under
CC conditions suitable for the cleansing of surface of the surface or an
CC item, to produce a cleansed surface or an item. The isolated subtilisin
CC variant is useful in cleaning composition for cleaning surface or an item
CC including dishware item, fabric item, laundry item, personal care items
CC and tableware item, e.g. dishes, cutlery, knives, forks, spoons,
CC chopsticks, glassware, pitchers, sauce boats, drinking vessels and
CC serving items. The subtilisin variant is a mature form having proteolytic
CC activity; and is not a cold water protease variant. The present sequence
CC represents a Bacillus lentus subtilisin GG36 protease variant protein
CC (N043R/S101D) used in the cleaning composition for cleaning surface or an
CC item. Note: The present sequence is not shown in the specification but is
CC derived from the Bacillus lentus subtilisin GG36 protease protein given
CC in the sequence listing (see BAG71943).
XX
SQ Sequence 269 AA;
Query Match 99.2%; Score 1351; Length 269;
Best Local Similarity 99.3%;
Matches 267; Conservative 1; Mismatches 1; Indels 0; Gaps 0;
Qy 1 AQSVPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLRIRGGASFVPGEPSTQDGN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AQSVPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLRIRGGASFVPGEPSTQDGN 60
Qy 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGASGEGSVSSIAQGLEWAGNNGMHVA 120
||||||||||||||||||||||||||||||||||||||:|||||||||||||||||||||
Db 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGASGDGSVSSIAQGLEWAGNNGMHVA 120
Qy 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGAGSISYPARYANAMAVGATDQNNNR 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGAGSISYPARYANAMAVGATDQNNNR 180
Qy 181 ASFSQYGAGLDIVAPGVNVQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 ASFSQYGAGLDIVAPGVNVQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
Qy 241 RNHLKNTATSLGSTNEYGSGLVNAEAATR 269
||||||||||||||| |||||||||||||
Db 241 RNHLKNTATSLGSTNLYGSGLVNAEAATR 269
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make and use the subtilase variant taught by O’Connell et al. and make further substitution of N43R as taught by Amin et al. for B. Lentus subtilase. One would have been motivated to make and use such subtilase variant because Amin et al. teach that making a N43R substitution greatly increases the cleaning performance of the detergent comprising said subtilase variant (see Table 2-6 on page 341). One would have had a reasonable expectation of success to make and use such subtilase variant because all of the required biochemical reagents and techniques to make and use B. Lentus subtilase variants were rampantly used as evidenced by O’Connell et al. and Amin et al. prior to the filing of the instant application.
Claim 11 is included in this rejection because the Office does not have the facilities for examining and comparing applicants’ subtilisin variant with the subtilisin variant of the prior art with regard to the storage stability. Therefore, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., the subtilisin variant of the prior art does not possess the improved storage stability compared to the claimed subtilisin variant). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
For the reasons provided herein, the invention as claimed is prima facie obvious over the combined teachings of the prior art.
Applicants’ Arguments:
In O’Connell substitutions N43D/E are suggested as possible additional substitutions in the variant of O’Connell. These are conservative substitutions of asparagine. No additional substitutions at position 43 are suggested in O’Connell and no rationale for selection of that particular position is provided in O’Connell.
Amin is a 441 page document with extensive lists of substitution combinations. Where the substitution N43R is provided, it is one of many possible substitutions provided in the document. Even in Table 2-6, cited by the examiner, 35 substitutions at 28 different positions are reported as contributing to the improved cleaning performance. Amin does not provide particular guidance that N43R is an individually particularly successful substitution. Amin does not describe that N43R would be a particularly successful substitution in any particular type of backbone. Amin does not describe that N43R in combination with S101E would be particularly beneficial. Amin describes other substitutions at position 101 (A and G), but not E. As such, it is respectfully submitted that O’Connell on view of Amin would not have led one of skill in the art to the presently claimed variant.
As set forth in MPEP § 2145, while some reconstruction is inherent in an obviousness analysis, such reasoning is only proper if it relies solely on knowledge within the level of ordinary skill in the art at the time of the invention and does not incorporate knowledge from Applicant’s disclosure; reliance on the latter constitutes improper hindsight. Selection of N43R as one single amino acid substitution from the 441 page Amin reference for incorporation into a variant of O’Connell as a substitute for the substitutions taught in O’Connell is not a selection that one of skill in the art would have made from the disclosure of the two cited references. The examiner’s assertion that one of skill would make such a selection relies on improper hindsight, as such a selection requires knowledge of Applicant’s claimed combination to select and assemble the particular N43R mutation from among many possibilities into the particular variant of O’Connell without any direction in the prior art leading the skilled artisan to that specific construction.
O’Connell in view of Amin therefore fails to provide any derivative basis for the claimed invention and, additionally, there would have been no logical reason for one of skill in the art to combine such references in the manner claimed. Accordingly, no basis of prima facie obviousness of the claimed invention is presented by such cited references.
Based on the foregoing, O’Connell in view of Amin fails to provide any logical basis for the variants recited in claims 1-2, 4-5, 7 and 10-14. O’Connell in view of Amin does not render the claimed invention obvious. Accordingly, withdrawal of the rejection of claims 1-2, 4-5, 7 and 10-14 under 35 U.S.C. § 103 (a) as being obvious over O’Connell in light of Amin is respectfully requested.
Examiner’s Explanations:
Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Furthermore, contrary to Applicants’ allegation that Amin does not provide particular guidance that N43R is an individually particularly successful substitution, the Examiner notes that this particular substitution, N43R, is mentioned 733 times in the specification of Amin et al. (i.e., “N043R” see below attached image), which signifies how important a substitution this was to Amin et al. which improved the cleaning performance of said subtilase variant (also see para [0114]).
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225
905
media_image1.png
Greyscale
PNG
media_image2.png
185
905
media_image2.png
Greyscale
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In conclusion, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make and use the subtilase variant taught by O’Connell et al. and make further substitution of N43R as taught by Amin et al. for B. Lentus subtilase as explained above.
For the reasons provided herein, the invention as claimed is prima facie obvious over the combined teachings of the prior art.
Double Patenting – MAINTAINED
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 1-7, 9-14 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,550,381. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patents anticipate those of the instant invention.
Claims 1-4 of the ‘381 patent recites a subtilase variant having protease activity and having at least 25% improved stability comparted to a subtilase with SEQ ID NO: 1 (100% identical to Applicants’ SEQ ID NO: 1), wherein the sequence of the variant subtilase has at least 90% but less than 100% sequence identity to the sequence of SEQ ID NO: 1, comprising the mutations X9E, X76D, and X262E (note this is a comprising claim and thus the subtilase variant may have additional mutations, same as the instantly claimed enzymes), and further comprising one or more substitutions including S3T, X9E, X43R, S101E, X205I, X206L, X209W, N261W and X259D wherein each position (e.g. the numbering) corresponds to the position of SEQ ID NO:2. The ‘381 patent further teach a liquid detergent composition comprising said subtilase variant (see claims 6-8). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation. Thus the scope of the claimed subtilase variants in ‘381 encompasses the subject matter of the instant claims 1-7, 9-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
Claims 1-7, 9-14 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,015,183. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patents anticipate those of the instant invention.
Claims 1-4 of the ‘183 patent disclose a protein comprising a subtilase variant having protease activity and having at least 25% improved stability comparted to the subtilase of SEQ ID NO: 1, wherein the sequence of the variant subtilase has at least 87% but less than 100% sequence identity to the sequence of SEQ ID NO: 1 (100% identical to Applicants’ SEQ ID NO: 1), comprising substitutions in positions X43R and X262E wherein each position corresponds to the position of the polypeptide of SEQ ID NO:2 (in claim 1 of ‘183), and further comprising one or more substitutions including S3T, X9E, X43R, S101E, X205I, X206L, X209W, N261W and X259D (‘183 claims 2 and 4). The ‘183 patent further teach a liquid detergent composition comprising said subtilase variant (‘183 claims 5-7). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation. Thus the scope of the claimed subtilase variants in ‘183 encompasses the subject matter of the instant claims 1-7, 9-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
Claims 1-7, 9-14 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,626,388. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patents anticipate those of the instant invention.
The claims of the ‘388 patent recite: a subtilase variant, having protease activity and at least 85% sequence identity to SEQ ID NO: 1 (100% identical to Applicants’ SEQ ID NO: 1), wherein the variant comprises one or more of the substitutions including X101E, X43R, X262E, and further comprising additional substitutions including X3T, X9E, X43R, N76D, S101E, X205I, X206L, X209W, N261W and X259D (see ‘388 claims 1, 4, 5 and 13). ‘388 patent further teach a liquid detergent composition comprising said subtilase variant (see ‘388 claims 8-10). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation. ‘388 patent further teach that said variant has an improved stability (see claim 6). Thus the scope of the claimed subtilase variants in ‘388 encompasses the subject matter of the instant claims 1-7, 9-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
Claims 1-7, 9-14 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,920,209. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patents anticipate those of the instant invention.
The claims of the ‘209 patent recite: a subtilase variant, having protease activity and at least 82% sequence identity to SEQ ID NO: 1 (100% identical to Applicants’ SEQ ID NO: 1), wherein the variant comprises one or more of the substitutions including S101E, N43R and L262E, and further comprising additional substitutions including S3T, S9E, N43R, N76D, S101E, V205I, Q206L, Y209W, S259D, and N261W (‘209 claims 1-6). The ‘209 patent further teach a liquid detergent composition comprising said subtilase variant (see claims ‘209 12-13). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation. The ‘209 patent further teach that said variant has an improved stability (see ‘209 claim 8). Thus the scope of the claimed subtilase variants in ‘209 encompasses the subject matter of the instant claims 1-7, 9-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
Claims 1-7, 9-14 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,591,586. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patents anticipate those of the instant invention.
The claims of the ‘586 patent recite a subtilase variant, having protease activity and at least 80% sequence identity to SEQ ID NO: 1 (100% identical to Applicants’ SEQ ID NO: 1), wherein the variant comprises one or more of the substitutions including S101E, N43R and L262E, and further comprising additional substitutions including S3T, S9E, N43R, N76D, S101E, V205I, Q206L, Y209W, S259D, and N261W (‘586 claims 1-3). The ‘586 patent further teach a liquid detergent composition comprising said subtilase variant (see ‘586 claims 9-10). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation. The ‘586 patent further teach that said variant has an improved stability (see ‘586 claim 5). Thus the scope of the claimed subtilase variants in ‘586 encompasses the subject matter of the instant claims 1-7, 9-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
Claims 1-14 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 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 the claims of the reference patents anticipate those of the instant invention.
The claims of the ‘491 patent recite: a subtilase variant, having protease activity and at least 90% sequence identity to SEQ ID NO: 1 (100% identical to Applicants’ SEQ ID NO: 1), wherein the variant comprises one or more of the substitutions including X101E, X43R and X262E, and further comprising additional substitutions including X3T, S9E, N43R, N76D, X194P, X205I, Q206L, X209W, S259D, and X261W (‘491 claims 1, 14-15 and 26). The ‘491 patent further teach a liquid detergent composition comprising said subtilase variant (see ‘491 claims 22-24). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation. The ‘491 patent further teach that said variant has an improved stability (see ‘491 claim 18). Thus the scope of the claimed subtilase variants in ‘491 encompasses the subject matter of the instant claims 1-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
Claims 1-7, 9-14 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,065,680. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patents anticipate those of the instant invention.
The ‘680 patent claims recite a subtilase variant having protease activity, wherein the sequence of the variant has at least 80% sequence identity to SEQ ID NO:1 (100% identical to Applicants’ SEQ ID NO: 1), wherein the variant comprises one or more of the substitutions including S101E, N43R and L262E, and further comprising additional substitutions including S3T, S9E, N43R, N76D, V205I, Q206L, Y209W, S259D, and N261W (‘680 claims 1-5). The ‘680 patent further teach a liquid detergent composition comprising said subtilase variant (see ‘680 claims 11-13). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation. The ‘680 patent also teach that said variant has an improved stability (see claim 7). Thus the scope of the claimed subtilase variants in ‘680 encompasses the subject matter of the instant claims 1-7, 9-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
Claims 1-2, 4-5, 7, 10-14 and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-10, 15 and 17-20 of copending Application No. 17/246,266. This rejection is newly presented, after consideration of related patent families.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference applications are coextensive in scope with the instantly claimed invention.
The 17/246,266 application claims are drawn to a subtilase variant having at least 25% improved stability, wherein the variant has a sequence identity of at least 85% but less than 100%, to SEQ ID NO:1 (100% identical to Applicants’ SEQ ID NO: 1), wherein the variant comprises one or more of the substitutions including S101E, X43R and X262E, and further comprising additional substitutions including S3T, X9E, N43R, X205I, X206L, X209W, X259D, and X261W (‘266 claims 1-5, 8-10, 15 and 17-20). The ‘266 application further teach a liquid detergent composition comprising said subtilase variant (see ‘266 claims 8-10). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation. Thus the scope of the claimed subtilase variants in ‘266 application encompasses the subject matter of the instant claims 1-2, 4-5, 7, 10-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-5, 12-14 and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-12, 28 and 30-37 of copending Application No. 17/252,446 in view of US Patent No. 10550381. This rejection is newly presented, after consideration of related patent families.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference applications are coextensive in scope with the instantly claimed invention.
The 17/252,446 application claims are drawn to a subtilase variant, wherein the variant has a protease activity and has a sequence identity of at least 80% but less than 100%, to SEQ ID NO:1 (100% identical to Applicants’ SEQ ID NO: 1), wherein the variant comprises one or more of the substitutions including X101E, and L262E, and further comprising additional substitutions including X205I, X206L, X209W with improved storage stability (‘446 claims 1, 9-12, 28). (note this is a comprising claim and thus the subtilase variant may have additional mutations, same as the instantly claimed enzymes). Even though ‘446 application does not teach N43R substitution, it would have been obvious for a person of ordinary skill in the art to insert an additional substitution N43R as taught by ‘381 patent. A POSITA would have been motivated to make such a substitution because it improves stability (see claim 1 of ‘381 patent). A POSITA would have had a high expectation of success for making and using said subtilase variant because all of the required biochemical reagents and techniques were rampantly available as evidenced by ‘446 application and ‘381 patent. ‘446 application further teach a liquid detergent composition comprising said subtilase variant (see ‘446 claim 28). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation.
Thus the scope of the claimed subtilase variants in ‘446 application encompasses the subject matter of the instant claims 1-2, 4-5, 12-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9-14 and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/043,532. This rejection is newly presented, after consideration of related patent families.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference applications are coextensive in scope with the instantly claimed invention.
The 18/043,532 application claims are drawn to a protease variant of a parent protease, wherein the variant has a sequence identity of at least at least 80% but less than 100%, to SEQ ID NO:1 (100% identical to Applicants’ SEQ ID NO: 1), wherein the variant comprises one or more of the substitutions including S101E, N43R and L262E, and further comprising additional substitutions including S3T, S9E, N43R, N76D, V205I, Q206L, Y209W, S259D, and N261W (‘532 claims 1-5). The ‘532 application further teach a liquid detergent composition comprising said subtilase variant (see ‘532 claims 20-22). Regarding claim 10, a subtilase variant according to claim 1 with a minimum of 3 substitutions has at least 98.8% identity to SEQ ID NO :1 meeting the percent identity limitation.
Regarding the improved storage stability, the recited storage stability property would be an inherent property of a subtilase variant of the reference application claims, as the reference claims encompass subtilase variants having identical structure to that of the instant claims. According to MPEP 2112.01.II. “ ‘Products of identical chemical composition cannot have mutually exclusive properties.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id”.
Thus the scope of the claimed subtilase variants in ‘532 application encompasses the subject matter of the instant claims 1-7, 9-14 and 18-19, with the elected mutations of “S101E”, “N43R” and “L262E”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner Notes:
As Applicants request that the double patenting issue be deferred, until one the present application is determined to be otherwise in condition for allowance, all of the previously made double patenting rejections are maintained for the same reasons provided previously.
Conclusion
Claims 1-14 and 18-19 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
THIS ACTION IS MADE FINAL. 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 extension fee 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 JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
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/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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