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 without traverse of Invention 1 in the reply filed on 12/05/2025 is acknowledged. Claims 41-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.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 29-40, 48 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 29-40, 48 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 29 recites the phrase “variant polypeptide of alpha-amylase according to SEQ ID NO:1 having alpha-amylase activity” which renders the claim vague and indefinite since it is unclear of the alpha amylase comprises the amino acid sequence of SEQ ID NO: 1.
Claim 29 recites the phrases “least one amino acid modification at an amino acid residue position number” which renders the claim vague and indefinite since the specific amino acid modification is not known and not recited in the claim. Dependent claims 30-40, 48 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 29-40, 48 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 variant polypeptides of alpha-amylase according to SEQ ID NO:1 having alpha-amylase activity and comprising an amino acid sequence which is at least 80% identical to the sequence according to SEQ ID NO: 1, wherein the amino acid sequence comprises a) at least one amino acid modification at an amino acid residue position number selected from the group consisting of: 23, 33, 125, 133, 157, 181, 214, 228, 260, 272, 323, 336, 349, 357, 407, and 408 or a combination thereof in the numbering of SEQ ID NO:1, or b) at least one amino acid modification at an amino acid residue position number selected from the group consisting of: 55 and 61 or a combination thereof in the numbering of SEQ ID NO: 1, or c) amino acid modifications at amino acid residue position numbers 205 and 206 in the numbering of SEQ ID NO: 1, or a combination thereof. 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 claimed genus of variant polypeptides of the alpha-amylase comprising the amino acid sequence of SEQ ID NO:1 having alpha-amylase activity.
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 modifications, amino acid sequences, structures, and/or fragments thereof correlate with alpha-amylase enzyme activity and having improvement in solubility compared to the alpha-amylase having the amino acid sequence of SEQ ID NO: 1.
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 variant polypeptides of alpha-amylase according to SEQ ID NO:1 having alpha-amylase activity and comprising an amino acid sequence which is at least 80% identical to the sequence according to SEQ ID NO: 1, wherein the amino acid sequence comprises a) at least one amino acid modification at an amino acid residue position number selected from the group consisting of: 23, 33, 125, 133, 157, 181, 214, 228, 260, 272, 323, 336, 349, 357, 407, and 408 or a combination thereof in the numbering of SEQ ID NO:1, or b) at least one amino acid modification at an amino acid residue position number selected from the group consisting of: 55 and 61 or a combination thereof in the numbering of SEQ ID NO: 1, or c) amino acid modifications at amino acid residue position numbers 205 and 206 in the numbering of SEQ ID NO: 1, or a combination thereof.
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 29-40, 48 are rejected under 35 U.S.C. 103 as being unpatentable over Accession ABG70531 (15-JUN-2007; PTO 892) in view of Bornscheuer et al. (Curr Protoc Protein Sci. 2011 Nov;Chapter 26:Unit26.7; PTO 892), Yoshikuni et al. (Curr Opin Chem Biol. 2007 Apr;11(2):233-9; PTO 892), US20040018607 (01/29/2004; PTO 892).
Accession ABG70531 teaches the alpha amylase having an amino acid sequence that is 100% identical to SEQ ID NO: 1 of the instant application and polypeptide is useful for liquefying a starch containing composition, hydrolysing a starch linkage, catalysing the breakdown of a starch and producing high-maltose or high-glucose syrup or mixed syrup (see attached record).
The teachings of the reference differ from the claims in that the reference does not teach the claimed alpha-amylase variant polypeptide.
Bornscheuer et al. 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).
Yoshikuni et al. (Curr Opin Chem Biol. 2007 Apr;11(2):233-9; PTO 892) teach protein engineering methodology to redesign enzyme function which was developed on the basis of the theories of divergent molecular evolution: (i) enzymes with more active and specialized functions have evolved from ones with promiscuous functions; (ii) this process is driven by small numbers of amino acid substitutions (plasticity); and (iii) the effects of double or multiple mutations are often additive (quasi-additive assumption). Yoshikuni et al. teach the impact of multiple mutations can be calculated by first determining the effects of a mutation at a single position and subsequently summing these effects using the quasi-additive assumption where the shape of the fitness landscape of a particular enzyme function can be estimated, and the combinations of mutations predicted to yield global optima for desired functions can then be selected and introduced into the enzymes. Yoshikuni et al. teach that the methodology has been demonstrated to be very powerful to redesign enzyme function. See entire publication and abstract especially pages 234-7 and Fig. 2.
US20040018607 teaches alpha-amylase polypeptides variants having at least 80% sequence identity with SEQ ID NO: 1 and comprising a number of substitution mutations. The taught variants include: SEQ ID NO: 4 (USPOP:ACW20811) having an activity optimum at pH4.5 to pH6.5 and having 96.1 % sequence identity with SEQ ID NO:1 of the instant application, comprising residues M23 and G125; SEQ ID NO: 38 ( USPOP:ACW20829) having 96.7% sequence identity with SEQ ID NO.1 and comprising residues G205 A206; SEQ ID NO:16 (USPOP:ACW20818) has 95.4% sequence identity with SEQ ID NO:1 and comprises residues M23 G205 and A206 which are equivalent to 23M, 125E, 205G and 206A substitutions to SEQ ID NO:1 of the instant application. See entire publication and claims especially paragraphs [0016]- [0091] and claims 52-81. US20040018607 teaches the following in paragraph [0407]:
“The invention provides detergent compositions comprising one or more polypeptides of the invention, and methods of making and using these compositions. The invention incorporates all methods of making and using detergent compositions, see, e.g., U.S. Pat. Nos. 6,413,928; 6,399,561; 6,365,561; 6,380,147. The detergent compositions can be a one and two part aqueous composition, a non-aqueous liquid composition, a cast solid, a granular form, a particulate form, a compressed tablet, a gel and/or a paste and a slurry form. The invention also provides methods capable of a rapid removal of gross food soils, films of food residue and other minor food compositions using these detergent compositions. Amylases of the invention can facilitate the removal of starchy stains by means of catalytic hydrolysis of the starch polysaccharide. Amylases of the invention can be used in dishwashing detergents in textile laundering detergents.”
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 and protein engineering methodology of taught by Bornscheuer et al. and Yoshikuni et al. on the alpha amylase of Accession ABG70531 to make the claimed variant alpha amylase having any of the recited amino acid substitutions and/or fragment thereof, and formulate a detergent composition comprising the variant alpha amylase as taught by US20040018607. 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 variant alpha amylase that can be used for the removal of starchy stains as taught by US20040018607. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because using protein engineering strategies and protein engineering methodology to improve or change the properties of proteins and enzymes 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 29-40, 48 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-30 of copending Application No. 19416347; claims 1-11, 17-20 of copending Application No. 19162689; claims 1-11, 17, 19 of copending Application No. 1871337; claims 1, 2, 4-8, 10, 11, 13, 14, 18-20, 37, 39, 42, 44-46 of copending Application No. 18266938. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims of the instant application are broad and widely varying and encompass any alpha amylase variant comprising the amino acid sequence of SEQ ID NO: 1. The claims and/or specification of the copending application teach the claimed variant polypeptide of alpha-amylase according to SEQ ID NO:1 having alpha-amylase activity and comprising an amino acid sequence which is at least 80% identical to the sequence according to SEQ ID NO: 1, wherein the amino acid sequence comprises a) at least one amino acid modification at an amino acid residue position number selected from the group consisting of: 23, 33, 125, 133, 157, 181, 214, 228, 260, 272, 323, 336, 349, 357, 407, and 408 or a combination thereof in the numbering of SEQ ID NO:1, or b) at least one amino acid modification at an amino acid residue position number selected from the group consisting of: 55 and 61 or a combination thereof in the numbering of SEQ ID NO: 1, or c) amino acid modifications at amino acid residue position numbers 205 and 206 in the numbering of SEQ ID NO: 1, or a combination thereof.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652