DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election with traverse of Group I (Invention I) in the reply filed on 08/04/2026 is acknowledged. The arguments filed have been considered but are not found persuasive. The combination of references stated below in the rejection of the claims under 35 U.S.C. 10 teach the claimed invention.
Claims 6-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5, 10-14 are under consideration in this Office Action.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 10-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites the phrase “comprising an amino acid residue substitution at a position corresponding to position H238 or E185 of an amino acid sequence set forth in SEQ ID NO: 2” which renders the claim vague and indefinite since it is unclear if the mutant actually comprises the amino acid sequence of SEQ ID NO: 2 and the substitutions at positions H238 or E185 or any other positions in any mutant.
Claims 1-5, 10-14 recite the phrase “positions corresponding to positions” which renders the claims vague and indefinite since it is unclear if the claims are limited to specific positions in the amino acid sequence of SEQ ID NO: 2 or any other positions in any mutant by recitation of “positions corresponding to positions”
Claim 1 recites the phrase in parenthesis “excluding a-amylase variants mutants having amino acid residue…of the same amino acid sequence)” which renders the claim vague and indefinite since it is unclear if the claim is limited to the subject matter stated in the parenthesis. Dependent claims 2-5, 10-14 are also rejected because they do not correct the defect.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 10-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a broad and widely varying genus of alpha-amylase mutants comprising an amino acid residue substitution at a position corresponding to position H238 or E185 of an amino acid sequence set forth in SEQ ID NO: 2, and an amino acid residue substitution shown in the following (A) or (B), the alpha-amylase mutant having at least 80% sequence identity to the amino acid sequence set forth in SEQ ID NO: 2 (excluding a-amylase variants mutants having amino acid residue substitutions at only three positions corresponding to positions H238, S239 and G178, at only three positions corresponding to positions H238, R209 and G178, and at only three positions corresponding to positions E185, N190 and G178 of the same amino acid sequence): (A) an amino acid residue substitution at one or more positions selected from the group consisting of positions corresponding to positions T116, A181, A199, A275, V277, A286 and L323 of the amino acid sequence set forth in SEQ ID NO: 2; or (B) an amino acid residue substitution at a position corresponding to position G178 of the amino acid sequence set forth in SEQ ID NO: 2, and an amino acid residue substitution at one or more positions selected from the group consisting of positions corresponding to positions N126, T129, N190, R209 and S239 of the same amino acid sequence. According to MPEP 2163:
“For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The reference of Chica et al. (Curr Opin Biotechnol. 2005 Aug;16(4):378-84; PTO 892) teaches that the complexity of the structure/function relationship in enzymes has proven to be the factor limiting the general application of rational enzyme modification and design, where rational enzyme modification and design requires in-depth understanding of structure/function relationships. The reference of Singh et al. (Curr Protein Pept Sci. 2017, 18, 1-11; PTO 892) reviews protein engineering methods including directed evolution, rational design, semi-rational design, and de-novo design; and states that despite the availability of a growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see entire publication especially Figs.1 and 3, and page 7, left column, lines 8-17). The reference teachings only provide guidance for searching and screening for the alpha-amylase mutants.
The specification as originally filed does not disclose a representative number of species encompassed by the claimed genus by actual reduction to practice. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences, structures, and amino acid mutations that correlate with the mutant having alpha-amylase activity.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed broad and widely varying genus of alpha-amylase mutants comprising an amino acid residue substitution at a position corresponding to position H238 or E185 of an amino acid sequence set forth in SEQ ID NO: 2, and an amino acid residue substitution shown in the following (A) or (B), the alpha-amylase mutant having at least 80% sequence identity to the amino acid sequence set forth in SEQ ID NO: 2 (excluding a-amylase variants mutants having amino acid residue substitutions at only three positions corresponding to positions H238, S239 and G178, at only three positions corresponding to positions H238, R209 and G178, and at only three positions corresponding to positions E185, N190 and G178 of the same amino acid sequence): (A) an amino acid residue substitution at one or more positions selected from the group consisting of positions corresponding to positions T116, A181, A199, A275, V277, A286 and L323 of the amino acid sequence set forth in SEQ ID NO: 2; or (B) an amino acid residue substitution at a position corresponding to position G178 of the amino acid sequence set forth in SEQ ID NO: 2, and an amino acid residue substitution at one or more positions selected from the group consisting of positions corresponding to positions N126, T129, N190, R209 and S239 of the same amino acid sequence.
Claim Rejections - 35 USC § 103
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 of this title, 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.
Claims 1-5, 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Accession A0A0V8JHI0 (16-MAR-2016; PTO 892) in view of US20210301223 (09/30/2021; PTO 892),
Bornscheuer et al. (Curr Protoc Protein Sci. 2011 Nov;Chapter 26:Unit26.7; PTO 892).
Accession A0A0V8JHI0 teaches the alpha-amylase having an amino acid sequence that has 98.3% identity to SEQ ID NO: 2 (see attached alignment). The teachings of the reference differ from the claims in that the reference does not teach the claimed alpha-amylase mutant.
US20210301223 teaches an amylase having 81% sequence identity with SEQ ID NO.: 2 of the instant application (see SEQ ID NO: 43), wherein the amino acid residues in said amylase that correspond to H238 and E185 of SEQ ID NO.: 2 of the instant application are different. US20210301223 teaches the use of a polypeptide having at least 80% sequence identity with said amylase as a component of a cleaning agent. See entire publication and claims especially paragraphs [0004], [0083]-[0106] and claims 1-8, 12-14. US20210301223 teaches the following in the claims:
1. A cleaning composition comprising a dispersin, at least one carbohydrase and a cleaning component, wherein the carbohydrase is a cellulase, an amylase, a mannanase or a xyloglucanase.
2. A cleaning composition according to claim 1 wherein the carbohydrase is a cellulase selected from the group consisting of a polypeptide having at least 80% sequence identity to the polypeptide shown in SEQ ID NO: 25, a polypeptide having at least 80% sequence identity to the polypeptide shown in SEQ ID NO: 26, a polypeptide having at least 80% sequence identity to the polypeptide shown in SEQ ID NO: 27, and a polypeptide having at least 80% sequence identity to the polypeptide shown in SEQ ID NO: 28.
3. A cleaning composition according to claim 1 wherein the carbohydrase is an amylase selected from the group consisting of a polypeptide having at least 80% % sequence identity to the polypeptide shown in SEQ ID NO: 30, a polypeptide having at least 80% sequence identity to the polypeptide shown in SEQ ID NO: 31, a polypeptide having at least 80% sequence identity to the polypeptide shown in SEQ ID NO: 32, a polypeptide having at least 80% sequence identity to the polypeptide shown in SEQ ID NO: 33, and a polypeptide having at least 80% sequence identity to the polypeptide shown in SEQ ID NO: 43.
Bornscheuer et al. (Curr Protoc Protein Sci. 2011 Nov;Chapter 26:Unit26.7; PTO 892) teach protein engineering strategies to improve or change the properties of proteins, teach concepts for protein engineering using rational design including substitution and/or deletion of amino acids, directed evolution, and combinations of them where different strategies are presented for identifying the best mutagenesis method, how to identify desired variants by screening or selection, and examples for successful applications are shown which enable researchers to choose the most promising tools to solve their protein engineering challenges (see entire publication especially pages 26.7.1- 26.7.10 and Tables 26.7.1, 26.7.2, and 26.7.3).
Therefore, it would have been obvious to use the protein engineering strategies of Bornscheuer et al. on the amylase of US20210301223 to make the claimed variant of a parent amylase.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by using the protein engineering strategies engineering strategies of Bornscheuer et al. on the alpha-amylase of Accession A0A0V8JHI0 to make the claim mutant having any of the amino acid modifications at the recited positions as recited in the claims. It would have been obvious to make an acidic, powder or liquid composition comprising the mutant and chelating agent where the compositions is a clothing cleaning agent or a dishwashing cleaning agent as routine optimization and/or as desired in view of the reference teachings. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to obtain a mutant for further studies on the biological activities and properties or can be used in a cleaning composition for dishwashing. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because modifying enzymes and proteins are known in the art as shown by the above reference teachings. Hence, the claimed invention as a whole is prima facie obvious.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of US Patent 5635468; and claims 1-10 of US Patent 6486113. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or specification of the patents teach the claimed α-amylase mustant comprising an amino acid residue substitution at a position corresponding to position H238 or E185 of an amino acid sequence set forth in SEQ ID NO: 2, and an amino acid residue substitution shown in the following recited (A) or (B). Thus, the teachings anticipate the claims.
Claims 1-5, 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-15 of copending Application 18029409; claims 13-19 of copending Application 18015752; claims 1-11 of copending Application 18722197; claims 1-14 of copending Application 18851320. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or specification of the copending application teach the claimed α-amylase mustant comprising an amino acid residue substitution at a position corresponding to position H238 or E185 of an amino acid sequence set forth in SEQ ID NO: 2, and an amino acid residue substitution shown in the following recited (A) or (B). Thus, the teachings anticipate the claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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