DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a CON of 15/793,576 (10/25/2017), which is a CON of 13/993,898
(9/30/2013), which is a 371 of PCT/EP11/72511 (12/13/2011), which claims priority to
DE102010063458.1 (12/17/2010) as reflected in the filing receipt issued on 8/10/2023.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/7/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Rejections
The rejection of claim 15 under 35 U.S.C. § 102 has been withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
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
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.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 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.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 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.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 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
Applicant’s arguments regarding the claimed method step of storing the liquid washing agent have been fully considered and are persuasive. The examiner agrees that Christianson does not expressly teach a method step of storing a liquid washing agent for at least 4 weeks. The rejection of claim 15 under 35 U.S.C. § 102 has been withdrawn.
However, upon further consideration, a new ground of rejection is made in view of Nickel and Christianson, as set forth above. Given this new ground of rejection, arguments presented regarding the rejection of claim 15 under 35 U.S.C. § 102 are moot.
Conclusion
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.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653