CTFR 18/173,620 CTFR 99485 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. 12-151 AIA 26-51 12-51 Status of Claims Receipt of Arguments/Remarks filed on 4/14/2026 is acknowledged. No claims were amended. Claim 15 is pending. Information Disclosure Statement The information disclosure statement (IDS) filed on 4/14/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Maintained rejections Claim Rejections - 35 USC § 103 07-103 AIA The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. 07-21-fti Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nickel et al. (CA2325159A1) in view of Christianson et al. (WO 95/23221) . Regarding claim 15, Nickel teaches a method of formulating liquid detergents (washing agents) comprising a protease and an amylase, made by mixing the ingredients of the detergent (Nickel p. 23 “Examples”; Table 1). Nickel teaches storing these liquid detergents for 16 weeks (i.e. at least 4 weeks) at temperatures from 0-40°C and observed no significant reduction in enzymatic activity (Nickel p. 26 para. 1). The amylase is Termamyl, which is an α-amylase (Nickel Table 1). The protease may be variants of the Bacillus lentus DSM 5483 alkaline protease (BLAP), and may be produced as described in WO 95/23221 (Nickel p. 4 para. 1). Nickel teaches that these liquid washing compositions have high stability in storage (Nickel p. 19 para. 4). Nickel does not expressly teach that the amino acid sequence of the protease is a sequence according to SEQ ID NO: 2. However, Nickel teaches that the protease may be produced as described in WO 95/23221, Christianson et al. Regarding claim 15, Christianson teaches novel mutant proteolytic enzymes in cleaning and detergent formulations (pg. 1 “Field of the Invention”). Christianson teaches a mutant Bacillus lentus DSM 5483 protease derived by replacement of at least one amino acid residue in the amino acid sequence shown in SEQ ID NO: 52 (Christianson claim 2). SEQ ID NO: 52 is identical to instant SEQ ID NO: 1, having an R at location 99, i.e. the protease in the control solution. Christianson teaches arginine at position 99 of SEQ ID NO: 52 is mutated to glutamic acid or aspartic acid (Christianson claim 2). Therefore, the mutated strain of Christianson, with arginine at position 99 mutated to glutamic acid, is identical to instant SEQ ID NO: 2. As the sequences are identical, the enzyme taught by Christianson would inherently have the claimed function of imparting a proteolytic activity to the protease, wherein the protease imparts a proteolytic activity to the washing or cleaning agent. Christianson teaches that the invention is directed to proteases with improvements compared to other commercial cleaners by substitution of amino acids in the substrate binding region, including R99 (pg. 3 lines 25-27, pg. 7 lines 14-16). Christianson teaches that mutations to the amino acid sequence of proteolytic enzymes result in enhanced stability compared to wild type proteases (pg. 9 lines 24-30). Christianson further teaches that the protease is included in a detergent composition (Christianson claim 6) and that the composition can include additional enzymes in addition to the protease, such as an amylase (pg. 23 lines 6-10). Christianson teaches that a liquid detergent can be produced by simply mixing the ingredients in water or a given solvent (pg. 25 lines 20-25). Given the teachings of Nickel that the protease may be produced according to teachings of Christianson WO 95/23221, it would have been obvious to a skilled artisan to use a protease having SEQ ID NO: 2 in a method according to Nickel, wherein the protease is mixed with α-amylase in a liquid washing composition and stored for over 4 weeks. A protease having this sequence is expressly taught by Christianson and used in a liquid washing formulation with improved stability as discussed above, and Nickel specifically teaches using a protease as described by Christianson. Claim 15 recites functional limitations to further define the cleaning agent, e.g. “wherein the liquid washing or cleaning agent exhibits increased storage stability of amylolytic activity after storage”. The claim is directed to a method of formulating a cleaning agent, with the method steps of mixing a protease according to SEQ ID NO: 2 and an α-amylase and storing for 4 weeks. As the liquid washing agent of Nickel is produced by this same method and includes both an α-amylase and a protease comprising the sequence of SEQ ID NO: 2 as taught by Christianson, this liquid washing agent is expected to have the functional features of increased storage stability over 4 weeks compared to a control liquid with an unmodified protease (i.e., having R at location 99 according to SEQ ID NO: 1). Further, as Christianson teaches that the engineered enzymes including the protease of SEQ ID NO: 2 have improved thermal and chemical stability (Christianson pg. 3 lines 25-30), it is expected that a liquid washing solution comprising the protease of SEQ ID NO: 2 and an α-amylase would have increased storage stability compared to a control solution with an unmodified protease according to SEQ ID NO: 1 . Double Patenting 08-33 AIA 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. 08-34 AIA Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 and 7-8 of U.S. Patent No. 9,163,226 in view of Nickel et al. (CA2325159A1) and Christianson et al. (WO 95/23221) . Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope . Regarding instant claim 15, Claim 1 of US Patent ‘226 recites a liquid washing or cleaning agent comprising a protease which is at least 80% identical to the amino acid sequence stated in SEQ ID NO. 1 and comprises in position 99 in the numbering according to SEQ ID NO. 1 the amino acid glutamic acid (E). SEQ ID NO: 1 with the mutation at position 99 as recited by US Patent ‘226 is identical to instant SEQ ID NO: 2. Claims 7-8 of US Patent ‘226 recite the liquid washing agent further comprising another enzyme, which includes an amylase. US Patent ‘226 does not recite a method of formulating the liquid washing or cleaning agent. However, this deficiency is cured by Nickel and Christianson. Regarding claim 15, Nickel teaches liquid detergents comprising a protease and an amylase, made by mixing the ingredients of the detergent (Nickel p. 23 “Examples”; Table 1). Nickel teaches storing these liquid detergents for 16 weeks (i.e. at least 4 weeks) and observed no significant reduction in enzymatic activity (Nickel p. 26 para. 1). The amylase is Termamyl, which is an α-amylase. The protease may be variants of the Bacillus lentus DSM 5483 protease, and may be produced as described in WO 95/23221 (Nickel p. 4 para. 1). Nickel teaches that these liquid washing compositions have high stability in storage (Nickel p. 19 para. 4). Nickel does not expressly teach that the amino acid sequence of the protease is a sequence according to SEQ ID NO: 2. However, Nickel teaches that the protease may be produced as described in WO 95/23221, Christianson et al. Christianson teaches novel mutant proteolytic enzymes in cleaning and detergent formulations (pg. 1 “Field of the Invention”). Christianson teaches a mutant Bacillus lentus DSM 5483 protease derived by replacement of at least one amino acid residue in the amino acid sequence shown in SEQ ID NO: 52 (Christianson claim 2). SEQ ID NO: 52 is identical to instant SEQ ID NO: 1. Christianson teaches that the amino acid replacement includes arginine at position 99, mutated to glutamic acid or aspartic acid (Christianson claim 2). Therefore, the mutated strain of Christianson, with arginine at position 99 mutated to glutamic acid, is identical to instant SEQ ID NO: 2. Christianson teaches that the invention is directed to proteases with improvements compared to other commercial cleaners by substitution of amino acids in the substrate binding region, including R99 (pg. 3 lines 25-27, pg. 7 lines 14-16). Christianson teaches that mutations to the amino acid sequence of proteolytic enzymes result in enhanced stability compared to wild type proteases (pg. 9 lines 24-30). Given the teachings of Nickel that the protease may be produced according to teachings of Christianson WO 95/23221, it would have been obvious to a skilled artisan to use a protease having SEQ ID NO: 3 in a method according to Nickel, wherein the protease is mixed with α-amylase in a liquid composition and stored for over 4 weeks, because a protease having this sequence is produced and used in a liquid washing formulation as taught by Christianson. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of patent ‘226 with Nickel and Christianson, incorporating a method of formulating the liquid washing agent by mixing the protease and amylase. Nickel and Christianson teach the same washing agent components as recited in patent ‘226, and a skilled artisan would be motivated to utilize this method as it is a simple technique of mixing ingredients for producing the liquid washing agent . 08-34 AIA Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 and 7-8 of U.S. Patent No. 10,760,036 in view of Nickel et al. (CA2325159A1) and Christianson et al. (WO 95/23221) . Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope . Claim 1 of US Patent ‘036 recites a detergent composition comprising a subtilase variant which is at least 90% identical to the amino acid sequence stated in SEQ ID NO. 3. SEQ ID NO: 3 as recited by US Patent ‘036 is identical to instant SEQ ID NO: 2. Claim 1 of US Patent ‘036 recites the liquid washing agent further comprising another enzyme, which includes an amylase. US Patent ‘036 does not recite a method of formulating the liquid washing or cleaning agent. However, this deficiency is cured by Nickel and Christianson. The teachings of Nickel and Christianson are set forth above. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of patent ‘036 with Nickel and Christianson, incorporating a method of formulating the liquid washing agent by mixing the protease and amylase. Nickel and Christianson teach the same washing agent components as recited in patent ‘036, and a skilled artisan would be motivated to utilize this method as it is a simple technique of mixing ingredients for producing the liquid washing agent . 08-34 AIA Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 and 7-8 of U.S. Patent No. 12,415,973 in view of Nickel et al. (CA2325159A1) and Christianson et al. (WO 95/23221) . Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope . Claim 1 of ‘973 recites a textile detergent comprising a protease having at least 80% sequence identity with SEQ ID NO: 1. SEQ ID NO: 1 as recited in ‘973 is 99.6% identical to instant SEQ ID NO: 2. Claims 5-6 of copending ‘973 recite the addition of an enzyme including α-amylase to the detergent composition. ‘973 does not recite a method of formulating the liquid washing or cleaning agent. However, this deficiency is cured by Nickel and Christianson. The teachings of Nickel and Christianson are set forth above. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of ‘973 with Nickel and Christianson, incorporating a method of formulating the liquid washing agent by mixing the protease and amylase. Nickel and Christianson teach the same washing agent components as recited in ‘973, and a skilled artisan would be motivated to utilize this method as it is a simple technique of mixing ingredients for producing the liquid washing agent . Response to Arguments 07-66 AIA The declaration under 37 CFR 1.132 filed 4/16/2026 is insufficient to overcome the rejection of claim 15 based upon 35 U.S.C. § 103 as set forth in the last Office action because: The declaration provides experimental results of stability tests comparing liquid amylase/protease formulations with a protease having SEQ ID NO: 2 (mutation R99E) to a wildtype control that differs only by having R at position 99. However, as set forth in the above rejection, the teachings of Nickel in view of Christianson render obvious the use of a protease having SEQ ID NO: 2 with a substitution of R99E. Any protease having the same structure, i.e. a substitution of R99E compared to the wildtype sequence, must inherently possess the features demonstrated in the declaration. Thus, the results showing improved properties of SEQ ID NO: 2 with R99E over wildtype are not persuasive. 35 U.S.C. § 103 rejection 07-37 AIA Applicant's arguments filed 4/16/2026 have been fully considered but they are not persuasive. Applicant argues that there is no motivation to specifically select a protease with an amino acid sequence of present SEQ ID NO: 2 because Nickel only mentions substitutions R99G, R99A, and R99S, and that the selection of R99E from among substitutions taught by Christianson constitutes improper hindsight reasoning. In response to this argument, it is noted that Nickel teaches that the protease may be produced as described by Christianson et al., and that modifications have been made such as for example at least one of the amino acid exchanges S3T, V4I, R99G, R99A, R99S, A188P, V193M and/or V1991 (Nickel p. 4 para. 1, emphasis added). While Nickel does not specifically recite R99E, the recited modifications are merely exemplary of some potential options, and are not an exhaustive list. A skilled artisan, in looking to the teachings of Christianson as taught by Nickel, would find that Christianson expressly teaches a mutant protease with a replacement of R99 for D or E (Christianson p. 82 claim 2), and also teaches a detergent composition comprising a mutated protease comprising one or more of the mutations: R99G, R99A, R99S, R99E, L211D, L211E, S154D, S154E (Christianson p. 82 claim 6). Thus, Christianson clearly teaches a protease with R99E as claimed. It would have been obvious for a skilled artisan to use such a protease given the expressly stated, finite number of modified proteases of Christianson, which have beneficial features such as improved stability, and the teachings of Nickel that the protease may be prepared as taught by Christianson. Applicant argues that after storage for 4 weeks the formulation containing an amylase and a protease of SEQ ID NO: 2 (i.e. R99E) exhibited surprisingly higher amylase activity than the control formulation, and Nickel only provides a generic statement that there was no significant reduction in enzymatic activity after storage. Applicant argues that Nickel does not differentiate between the activities of the individual enzymes, or clarify which enzymatic activities were measured or how such measurements were performed. In response to this argument, as discussed above, a method of producing a liquid washing agent, comprising the active steps of mixing a protease according to SEQ ID NO: 2 and an α-amylase and storing the liquid washing agent for at least 4 weeks, is obvious in view of Nickel and Christianson. As all of the claimed active method steps are taught by Nickel and Christianson, the same result of higher amylase activity and storage stability must necessarily occur, absent any unclaimed essential features. Therefore, the argument that the claimed method using SEQ ID NO: 2 with R99E results in greater storage stability is not persuasive, as Nickel and Christianson teach a method using this enzyme with the same active steps as claimed. Further, Christianson teaches that the engineered enzymes including the protease of SEQ ID NO: 2 have improved thermal and chemical stability (Christianson pg. 3 lines 25-30) Applicant argues that even with the addition of a liquid formulation containing an enzyme stabilizer system as taught by Nickel, protease of SEQ ID NO: 2 (R99E) vs. a protease with R99 has surprisingly higher amylase activity after storage which cannot be attributed to the enzyme stabilizer system. In response to this argument, it is again noted that the teachings of Nickel in view of Christianson render obvious a method using a protease having SEQ ID NO: 2 (R99E). Thus, the comparison of R99E to WT with or without the presence of a stabilizer system is irrelevant in this case, as it would have been obvious to use an enzyme having the R99E mutation, which must necessarily have the claimed activity. Non-statutory double patenting rejection For the same reasons set forth above, the rejection of claim 15 on the grounds of non-statutory double patenting is maintained. Conclusion Claim 15 is rejected. 07-39 AIA 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 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 EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET. 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, Sharmila Landau can be reached at (571)272-0614. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /EMILY F EIX/Examiner, Art Unit 1653 /SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653 Application/Control Number: 18/173,620 Page 2 Art Unit: 1653 Application/Control Number: 18/173,620 Page 3 Art Unit: 1653 Application/Control Number: 18/173,620 Page 4 Art Unit: 1653 Application/Control Number: 18/173,620 Page 5 Art Unit: 1653 Application/Control Number: 18/173,620 Page 6 Art Unit: 1653 Application/Control Number: 18/173,620 Page 7 Art Unit: 1653 Application/Control Number: 18/173,620 Page 8 Art Unit: 1653 Application/Control Number: 18/173,620 Page 9 Art Unit: 1653 Application/Control Number: 18/173,620 Page 10 Art Unit: 1653 Application/Control Number: 18/173,620 Page 11 Art Unit: 1653 Application/Control Number: 18/173,620 Page 12 Art Unit: 1653 Application/Control Number: 18/173,620 Page 13 Art Unit: 1653
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