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 in the reply filed on 05/18/2026 is acknowledged. The arguments filed have been considered but are not found persuasive. Restriction for examination purposes as previously stated is proper because all these inventions listed in this action are independent or distinct for the reasons of record and there would be a serious search and examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Claims 27-32, 39, 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.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 21-26, 33-38 are under consideration in this Office Action.
Acknowledgment is made of applicant's claim for foreign priority based on an applications EUROPEAN PATENT OFFICE (EPO) 18168189.1 04/19/2018, and
EUROPEAN PATENT OFFICE (EPO) 18153173.0 01/23/201.
It is noted, however, that applicant has not filed a certified copy of the applications as required by 37 CFR 1.55.
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 21-26, 33-38 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 variants having endoglucanase activity, where the variant has at least 80% sequence identity to the endoglucanase having SEQ ID NO: 2 and comprises a substitution in one or more positions corresponding to the positions of SEQ ID NO: 1 of : 6, 85, 96, 101, 103, 104, 114, 132, 146, 148, 159, 194 or 213 and where the variant has improved stability in an aqueous composition comprising a protease. 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 variant having endoglucanase 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 sequences and structures correlate with endoglucanase activity where the said variant has improved stability in an aqueous composition comprising a protease.
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 genus of variants having endoglucanase activity, where the variant has at least 80% sequence identity to the endoglucanase having SEQ ID NO: 2 and comprises a substitution in one or more positions corresponding to the positions of SEQ ID NO: 1 of : 6, 85, 96, 101, 103, 104, 114, 132, 146, 148, 159, 194 or 213 and where the variant has improved stability in an aqueous composition comprising a protease.
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 21-26, 33-38 are rejected under 35 U.S.C. 103 as being unpatentable over WO2017106676 (06/22/2017; IDS filed 09/25/2024) in view of Accession O93782 (01-MAY-1999; PTO 892), Bornscheuer et al. (Curr Protoc Protein Sci. 2011 Nov;Chapter 26:Unit26.7; IDS filed 09/25/2024), and Yoshikuni et al. (Curr Opin Chem Biol. 2007 Apr;11(2):233-9; IDS filed 09/25/2024).
Accession O93782 teaches the Humicola insolens cellulase having an amino acid sequence that is 98.4% identical 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 variant having endoglucanase activity, where the variant has at least 80% sequence identity to the endoglucanase having SEQ ID NO: 2 and comprises a substitution in one or more positions corresponding to the positions of SEQ ID NO: 1 of : 6, 85, 96, 101, 103, 104, 114, 132, 146, 148, 159, 194 or 213 and where the variant has improved stability in an aqueous composition comprising a protease in comparison with the endoglucanase having the sequence of SEQ ID NO: 2.
WO2017106676 teaches the Thielavia terrestris cellulase mature protein ("120H") having the amino acid sequence of SEQ ID NO: 17, and further mutants thereof with improved protease resistance shown in Table 12 on page 51 (see document WRITTEN OPINON OF THE INTERNATIONAL SEARCHING AUTHORITY, PCT/EP2019/059460, dated 09/25/2020). WO2017106676 teaches compositions comprising cellulase variants and one or more additional enzymes selected among: protease, lipase, cutinase, an amylase, carbohydrase, cellulase, pectinase, mannanase, arabinase, galactanase, xylanase, oxidase, a laccase, and/or peroxidase where the composition is a liquid detergent composition. WO2017106676 teaches compositions comprising cellulase variants and surfactants, builders, co-builders, and/or polymers. See entire publication and claims especially claims 1-18.
Bornscheuer et al. teach protein engineering strategies to improve or change the properties of proteins, teach concepts for protein engineering using rational design including inserting extra amino acids or deleting 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. 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.
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 Humicola insolens cellulase of Accession O93782 and obtaining the variants as recited in the claims. 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 engineered cellulase variants that have improved stability in an aqueous composition comprising a protease in comparison with the endoglucanase of SEQ ID NO: 2. It would have been obvious to one of ordinary skill in the art to make compositions comprising the cellulase variants and the recited enzymes and recited surfactants or builders, and the composition being a liquid detergent composition. 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 enzymes including cellulase are known in the art as shown by the 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 21-26, 33-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of U.S. Patent 11661592 (05/30/2023; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or the specification of the patent teach a variants having endoglucanase activity, where the variant has at least 80% sequence identity to the endoglucanase having SEQ ID NO: 2 and comprises a substitution in one or more positions corresponding to the positions of SEQ ID NO: 1 of : 6, 85, 96, 101, 103, 104, 114, 132, 146, 148, 159, 194 or 213 and where the variant has improved stability in an aqueous composition comprising a protease. Thus, the teachings anticipate the claimed invention.
Claims 21-26, 33-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of U.S. Patent 12129498 (2024-10-29; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or the specification of the patent teach a variants having endoglucanase activity, where the variant has at least 80% sequence identity to the endoglucanase having SEQ ID NO: 2 and comprises a substitution in one or more positions corresponding to the positions of SEQ ID NO: 1 of : 6, 85, 96, 101, 103, 104, 114, 132, 146, 148, 159, 194 or 213 and where the variant has improved stability in an aqueous composition comprising a protease. Thus, the teachings anticipate the claimed invention.
Conclusion
No claim is 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.
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, Robert Mondesi can be reached on (408)918-7584. 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.
/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
Prosecution Insights