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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/12/2026 has been entered.
Election/Restrictions
Claims 12-13, 17-21, 25-27, and 32-37 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Accordingly, claims 1, 9-11, 28, and 30-31 have been examined on the merits.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
RE: Rejection of claims 1-4, 6-11, and 28 over Hellmuth et al. in view of Toscano et al. 2
Applicant traverses the rejections because there is allegedly no reason to specifically pick Q200L, Y203W, and L256E from Toscano et al. 2’s long list of mutations and exclude additional mutations. Since said mutations are applied to standard savinase, it is argued that there is no expectation of success in further mutating Hellmuth et al.’s subtilase variant based on the mutations of Toscano et al..
Applicant’s traversal has been fully considered and is found unpersuasive. First, MPEP § 2131.02(II) states that a prior art disclosing the claimed species anticipates the claim regardless of the number of other named species. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught). Thus, the disclosed list of mutations being long does not invalidate Toscano et al. 2’s teaching that any one of them can increase the storage stability of subtilase.
Second, it is well-understood and routine in the art to have multiple mutations in order to achieve a desired property. As previously pointed out, Hellmuth et al. states “Advantageous properties of individual mutations, e.g. individual substitutions, can supplement one another. A protease already optimized with regard to specific properties, for example with regard to its stability in terms of surfactants and/or bleaching agents and/or other components, can therefore be additionally refined in the context of the invention” (¶ 0048). Toscano et al. 2 also teaches that modified proteases, when formulated in detergent compositions, should be stabilized in order to maintain optimal effect until use (lines 1-8, page 2) and this can be achieved by mutating one or more amino acids such as Q200L, L203W, and Y256E in SEQ ID NO: 1 (Savinase®) (lines 33-35, page 11). Thus, one with ordinary skill in the art would have further altered Hellmuth et al.’s subtilase variant at Q200L, L203W, and Y256E with reasonable expectation that it would improve storage stability.
Lastly, it should be noted that the presence of unrecited mutations is not prohibited. The claims, as currently written, only require that the subtilase variant comprises Q206L, Y209W, L262 mutations along with 3T, 4I, 99D, 101E, 103A, 104I, 160S, and 205I. Furthermore, there is no evidence that having additional mutations would have hindered improving the subtilase variant’s storage stability in detergent composition. Applicant only tested a few subtilase variants, the closest ones having either “N43R, Y209W, L262E” or “A194P, Q206L, Y209W” mutations (Table 1, page 42). Results do not clearly demonstrate that the additional mutation (N43R or A194P) negatively affects storage stability.
The rejections of record are therefore maintained.
Maintained rejections
Claims 1, 9-11, 28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Hellmuth et al. (US 2014/0227764 A1, hereinafter “Hellmuth”) in view of Toscano et al. (WO 2016/097405 A1, hereinafter “Toscano2”).
Hellmuth et al. teaches protease variants comprising an amino acid sequence that is at least 70% identical to SEQ ID NO: 1 (Bacillus lentus subtilase) and amino acid substitution R99E or R99D in combination with at least two additional amino acids substitutions selected from the group consisting of S3T, V4I, and V199I (¶ 0010).
With the substitution at R99 to E or D (which corresponds to position 97), the resulting sequences SEQ ID NO: 2 and SEQ ID NO:3 are found to be 100% and 99.8% identical to applicant’s SEQ ID NO: 1, respectively. Sequence alignments of Hellmuth et al.’s SEQ ID NO: 2 or SEQ ID NO: 3 with applicant’s SEQ ID NO: 1 show that the disclosed variants fulfill the limitation “wherein the variant comprises the following amino acids in the indicated positions: T in position 3, I in position 4, D in position 99, E in position 101, A in position 103, I in position 104, S in position 160 and I in position 205” (which correspond to positions 3, 4, 97, 99, 101, 102, 157, and 199, respectively, in the prior art’s sequence).
Applicant’s SEQ ID NO: 1 (Qy) vs. Hellmuth et al.’s SEQ ID NO: 2 (Db)
Query Match 100.0%; Score 1363; DB 1; Length 269;
Best Local Similarity 100.0%;
Matches 269; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AQTIPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLNIRGGASFVPGEPSTQDGN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AQTIPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLNIRGGASFVPGEPSTQDGN 60
Qy 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGADGEGAISSIAQGLEWAGNNGMHVA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGADGEGAISSIAQGLEWAGNNGMHVA 120
Qy 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGASSISYPARYANAMAVGATDQNNNR 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGASSISYPARYANAMAVGATDQNNNR 180
Qy 181 ASFSQYGAGLDIVAPGVNIQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 ASFSQYGAGLDIVAPGVNIQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
Qy 241 RNHLKNTATSLGSTNLYGSGLVNAEAATR 269
|||||||||||||||||||||||||||||
Db 241 RNHLKNTATSLGSTNLYGSGLVNAEAATR 269
Applicant’s SEQ ID NO: 1 (Qy) vs. Hellmuth et al.’s SEQ ID NO: 3 (Db)
Query Match 99.8%; Score 1360; DB 1; Length 269;
Best Local Similarity 99.6%;
Matches 268; Conservative 1; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AQTIPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLNIRGGASFVPGEPSTQDGN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AQTIPWGISRVQAPAAHNRGLTGSGVKVAVLDTGISTHPDLNIRGGASFVPGEPSTQDGN 60
Qy 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGADGEGAISSIAQGLEWAGNNGMHVA 120
||||||||||||||||||||||||||||||||||||||:|||||||||||||||||||||
Db 61 GHGTHVAGTIAALNNSIGVLGVAPSAELYAVKVLGADGDGAISSIAQGLEWAGNNGMHVA 120
Qy 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGASSISYPARYANAMAVGATDQNNNR 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NLSLGSPSPSATLEQAVNSATSRGVLVVAASGNSGASSISYPARYANAMAVGATDQNNNR 180
Qy 181 ASFSQYGAGLDIVAPGVNIQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 ASFSQYGAGLDIVAPGVNIQSTYPGSTYASLNGTSMATPHVAGAAALVKQKNPSWSNVQI 240
Qy 241 RNHLKNTATSLGSTNLYGSGLVNAEAATR 269
|||||||||||||||||||||||||||||
Db 241 RNHLKNTATSLGSTNLYGSGLVNAEAATR 269
Hellmuth is different from the claimed invention in that it does not explicitly teach “mutations Q206L, Y209W, and L262E” (which corresponds to positions 200, 203, and 256, respectively).
However, Toscano2 teaches that Bacillus lentus subtilase can be mutated at Q200L, Y203W, and L256E (Abstract; page 11, lines 20-25; page 29, lines 5-11). Toscano further teaches that the point mutations improve binding of the subtilase variant to an inhibitor of the variant (Abstract). Toscano2 teaches that “a generally encountered problem using proteases with or without other enzymes in particular liquid detergent compositions, is that it’s needed to stabilize the protease in order to minimize loss due to proteolysis or auto-proteolysis during storage in the detergent in order not to get reduced enzyme wash performance when finally washed” (page 1, lines 19-23). Toscano2 teaches that “the storage stability of enzymes in liquid cleaning compositions has been improved for example by adding various protease inhibitors or stabilizers,” including the use of reversible protease inhibitors (page 1, lines 23-25). Toscano2 teaches the subtilase variants are formulated into cleaning compositions such as detergent compositions (page 21 lines 12-13).
One of ordinary skill in the art would have been motivated to modify Hellmuth in view of Toscano2 in order to advantageously enhance binding of protease to an inhibitor, thereby optimizing wash performance and stability, with a reasonable expectation of success. It can be expected that having both Hellmuth’s mutations and Toscano2 mutations would provide the benefits of enhanced cleaning performance and increased stability. Obviousness is based on the rationale that some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Regarding instant claims 10-11 and 30-31, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant taught by Hellmuth and Toscano. In the Response filed on 11/30/2023, Applicant indicates (emphasis added) that:
Applicants elect the species of a variant with substitutions at positions 206 and 209 and one or more additional mutations selected from positions 9, 43, 76, 131, 158, 161, 194, 212, 216, 259, 261 and 262. Specifically, the elected substitutions at positions 206 and 209 would be Q206L and Y209W. Other, nonelected substitutions at these positions are recited in claim 2. The election reads on all of the claims of Group I.
As discussed above, Hellmuth and Toscano2 teach each of the elected point mutations as well as the specific amino acids at the position recited by instant claim 1. “Products of identical chemical composition can not 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.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
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.
RE: Double patenting rejections
Applicant did not submit any arguments against the double patenting rejections and merely requested that said rejections be deferred until claims are found allowable.
Given that applicant did not file a terminal disclaimer nor submit arguments to show distinction between the claims of the instant application vs. cited patents/co-pending application, the double patenting rejections are maintained as proper.
Maintained rejections
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 and 9-13 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 conflicting claims encompass a subtilase variant, which can be formulated as a detergent, having protease activity and having at least 25% improved stability compared to a subtilase with SEQ ID NO: 1 with points mutations at S3T, V4I, S99D, S101E, S103A, V104I, V205I, Q206L, Y209W, and L262E.
Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment above with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5 and 8-10 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 conflicting claims encompass a subtilase variant, which can be formulated as a detergent, having protease activity and having at least 25% improved stability compared to a subtilase with SEQ ID NO: 1 with points mutations at S3T, V4I, S99D, S101E, S103A, V104I, X205I, X206L, X209W, and X262E. Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment below with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 15, and 17-20 of copending Application No. 17/246,266 (recently allowed).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims encompass a subtilase variant, which can be formulated as a detergent, having protease activity and having at least 25% improved stability compared to a subtilase with SEQ ID NO: 1 with points mutations at S3T, V4I, S99D, S101E, S103A, V104I, X205I, X206L, X209W, and X262E. Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment below with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
Claims 1, 9-11, 28, and 30-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 20-22 of copending Application No. 18/043,532 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a protease (subtilase) variant with the following point mutations: X3T; X4I; X99D; X101E; X103A; X104I; X160S; and X205I as well as Q206L, Y209W, and L262E with improved solubility and protease activity formulated, e.g., as a detergent. Instant SEQ ID NO: 1 is at least 98% identical to conflicting SEQ ID NO: 1 (see alignment below).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 11-13 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 conflicting claims encompass a subtilase variant with points mutations at X3T, X4I, X99D, X101E, X103A, X104I, X205I, X206L, X209W, and X262E. Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment below with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,920,209.
The claims at issue are not identical but they are not patentably distinct from each other since the conflicting claims encompass a subtilase variant, which can be formulated as a detergent with mutations at X3T, X4I, X99D, X101E, X103A, X104I, X205I, Q206L, Y209W, and L262E.
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment above with an S at position 160).
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 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 conflicting claims encompass a subtilase variant, which can be formulated as a detergent, with points mutations at S3T, V4I, S99D, S101E, S103A, V104I, V205I, Q206L, Y209W, and L262E. Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment below with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 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 conflicting claims encompass a subtilase variant with points mutations at S3T, V4I, S99D, S101E, S103A, V104I, V205I, Q206L, Y209W, and L262E. Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment below with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-15 of copending Application No. 18/759,529 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a protease (subtilase) variant with the following point mutations: X3T; X4I; X99D; X101E; X103A; X104I; X160S; and X205I as well as Q206L, Y209W, and L262E formulated, e.g., as a detergent. Instant SEQ ID NO: 1 is at least 98% identical to conflicting SEQ ID NO: 1 (see alignment below).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 14-22, and 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 conflicting claims encompass a subtilase variant, which can be formulated as a detergent, with points mutations at X3T, X4I, X99D, X101E, X103A, X104I, X205I, Q206L, Y209W, and L262E. Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment below with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 14-19 of U.S. Patent No. 11,591,585.
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims encompass a subtilase variant, which can be formulated as a detergent (laundry) with points mutations at X3T, X4I, X99D, X101E, X103A, X104I, X205I, Q206L, Y209W, and L262E. Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment below with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-7, and 9-13 of U.S. Patent No. 11,162,089.
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims encompass a subtilase variant, which can be formulated as a detergent (laundry) with points mutations at X3T, X4I, X99D, X101E, X103A, X104I, X205I, Q206L, Y209W, and L262E Conflicting SEQ ID NO: 1 shares at least 98% identity with to instant SEQ ID NO: 1 (see alignment below with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15-20 of copending Application No. 18/401,373 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a protease (subtilase) variant with the following point mutations: X3T; X4I; X99D; X101E; X103A; X104I; X160S; and X205I as well as Q206L, Y209W, and L262E with improved solubility and protease activity formulated, e.g., as a detergent. Instant SEQ ID NO: 1 is at least 98% identical to conflicting SEQ ID NO: 1 (see alignment below).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 9-11, 28, and 30-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 14 of copending Application No. 17/299,273 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a protease (subtilase) variant with the following point mutations: S3T; V4I; S99D; S101E; S103A; V104I; G160S; and V205I as well as Q206L, Y209W, and L262E formulated, e.g., as a detergent. Instant SEQ ID NO: 1 is at least 98% identical to conflicting SEQ ID NO: 1 (see alignment below).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 9-11, 28, and 30-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 17/435,555 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a protease (subtilase) variant with the following point mutations: S3T; V4I; S99D; S101E; S103A; V104I; G160S; and V205I as well as Q206L, Y209W, and L262E formulated, e.g., as a detergent. Instant SEQ ID NO: 1 is at least 98% identical to conflicting SEQ ID NO: 1 (see alignment below).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 9-11, 28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,415,973 (copending Application No. 17/920,410).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a protease (subtilase) variant, formulated as a detergent, with the point mutations corresponding to: T3; I4; 99E; 104I; G160S; V205I as well as Q206L, Y209W, and L262E formulated, e.g., as a detergent. Instant SEQ ID NO: 1 is at least 98% identical to conflicting SEQ ID NO: 1 (see alignment below with an S at position 160).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
Claims 1, 9-11, 28, and 30-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17/927,164 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a protease (subtilase) variant with the following point mutations: X3T; X4I; X99D; X101E; X103A; X104I; X160S; and X205I as well as Q206L, Y209W, and L262E with improved solubility and protease activity formulated, e.g., as a detergent. Instant SEQ ID NO: 1 is at least 98% identical to conflicting SEQ ID NO: 1 (see alignment below).
PNG
media_image1.png
470
975
media_image1.png
Greyscale
Regarding instant claims 9-11, absent evidence to the contrary, the recited storage stability parameters would be an inherent property of the subtilase variant of the conflicting claims since the subtilase variant would have an identical structure. “Products of identical chemical composition can not 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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, Melenie L. Gordon can be reached at (571) 272-8037. 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.
/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651