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 Group I (Invention I) in the reply filed on 08/27/2025 is acknowledged. Claims 52, 54, 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.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 32-51, 53, 55-56 are pending and under consideration in this Office Action.
Title
. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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 32-51, 53, 55-56 are rejected under 35 U.S.C. 103 as being unpatentable
over Accession BCB68303 (27-AUG-2015; PTO 892) in view of Bornscheuer et al. (Curr Protoc Protein Sci. 2011 Nov;Chapter 26:Unit26.7; PTO 892), WO2013033318 (03/07/2013; IDS filed 04/27/2023).
Accession BCB68303 teaches the Saccharomonospora viridis cutinase having an amino acid sequence that is 100% identical to SEQ ID NO: 1 (see attached record).
The teachings of the reference differs from the claims in that the reference does not teach the claimed esterase having the recited amino acid substitutions.
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).
WO2013033318 teaches Saccharomonospora viridis DSM 43017 lipase 2 having 304 amino acid residues that has 100% identity over 260 positions in a common overlap with SEQ ID NO: 1 of the instant application. WO2013033318 teaches that substitutions may be made in this lipase in order to improve its properties, in particular its thermostability. WO2013033318 teaches detergent compositions comprising said lipase. See entire publication and claims especially SEQ ID NO18; Example 6; page 17 line 14 to page 22, line 16, and claims 1-37.
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 of Bornscheuer et al. on the Saccharomonospora viridis cutinase of Accession BCB68303 to make the modified esterase comprising the amino acid sequence SEQ ID NO: 1 and amino acid substitutions 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 a modified esterase with modified properties that can be used to processes for degrading polyester containing material including plastic products. It would have been obvious to make a detergent composition and polyester containing material comprising the modified esterase in view of the teachings of WO2013033318. One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success in view of the reference teachings showing modification of enzymes for improved properties. Hence, the claimed invention as a whole is prima facie
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 32-51, 53, 55-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US Patent No. 12344714, claims 1-11 of US Patent No. 10584320, claims 1-13 of US Patent No. 11535832, claims 1-6 of US Patent No. 10590401, claims 1-9 of US Patent No. 11414651, claims 1-9 of US Patent No. 11072784. 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 esterase which (i) has at least 80%, 85%, 90%, 95%, 96%, 97%, 98% or 99% identity to the full length amino acid sequence set forth in SEQ ID NO: 1, and (ii) has at least one amino acid substitution at a position selected from the group consisting of F211, E13, T48, T52, T63, W71, Y108, A127, M129, G137, P153, L154, T155, L159, D160, K161, T170, E204, A212, P213, N214, K222, L242, P244 and P259, and/or at least one amino acid substitution selected from the group consisting of T12N/D/E/I/M/Q, S24P, A55L, F62M, S65N/Q, S68H, L92W, Q94G/N/P/T/Y, R100S, P123R/W, S138T, T179H/N/Q/A/E, S182E/D, T185E/D, E192D, D206K, G207K, T209D/L, I215F, P216D, V224G, Q240D/T and N245Y/P wherein the positions are numbered by reference to the amino acid sequence set forth in SEQ ID NO: 1, (iii) has a polyester degrading activity and (iv) exhibits an increased thermostability and/or an increased degrading activity compared to the esterase of SEQ ID NO: 1. Thus, the teachings anticipate the claimed invention.
Claims 32-51, 53, 55-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-52 of Application Serial No. 18034080, claims 27-45 of Application Serial No. 18710760. 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 applications teach the claimed esterase which (i) has at least 80%, 85%, 90%, 95%, 96%, 97%, 98% or 99% identity to the full length amino acid sequence set forth in SEQ ID NO: 1, and (ii) has at least one amino acid substitution at a position selected from the group consisting of F211, E13, T48, T52, T63, W71, Y108, A127, M129, G137, P153, L154, T155, L159, D160, K161, T170, E204, A212, P213, N214, K222, L242, P244 and P259, and/or at least one amino acid substitution selected from the group consisting of T12N/D/E/I/M/Q, S24P, A55L, F62M, S65N/Q, S68H, L92W, Q94G/N/P/T/Y, R100S, P123R/W, S138T, T179H/N/Q/A/E, S182E/D, T185E/D, E192D, D206K, G207K, T209D/L, I215F, P216D, V224G, Q240D/T and N245Y/P wherein the positions are numbered by reference to the amino acid sequence set forth in SEQ ID NO: 1, (iii) has a polyester degrading activity and (iv) exhibits an increased thermostability and/or an increased degrading activity compared to the esterase of SEQ ID NO: 1. Thus, the teachings anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652