DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 is required to end in a period. In claim 4, a conjunction “and” should appear between (g) and (h).
Appropriate correction is required.
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.
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Claims 1-14 (all pending claims) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 13 of U.S. Patent No. 9109209 B2 in view of Saville et al. (WO 2010/099501 A1) (see IDS).
Patented claim 3 depends from patented claim 1 reciting:
1. An engineered transaminase polypeptide comprising an amino acid sequence having at least 80% sequence identity to reference sequence SEQ ID NO:4 and at least an amino acid residue difference as compared to SEQ ID NO:4 at residue position X192, and the substitution X136L.
Patented claim 3 further recites a list of additional substitutions including X191A such that patented claim 3 directly recites and anticipates an engineered transaminase identical to SEQ ID NO: 4 except having a substitution at X192 combined with X136L and X191A as to anticipate claims 1-3.
Regarding claim 5, patented claim 3 recites a long list of “one or more residue differences as compared to SEQ ID NO: 4” including X191A as discussed. Other substitutions recited includes X21L. Wherein patented claim 3 expressly recites “one or more” residue differences, regardless of the extensive list of substitutions recited any particular pairing of two such differences, such as X21L and X191A is readily identifiable as a suggest embodiment of patent claim 3 such that an ordinarily skilled artisan at time of filing or invention would have been motivated to embody the substitutions X21L and X191A within an embodiment engineered transaminase of patented claim 3 as to meet the features of claim 5.
Regarding claims 6-14, Saville teaches transaminases having over 90% identity to recited SEQ ID NO: 4 and transaminases of the patented claims. As explained in Saville, Savile, para. [0026], states any engineered/recombinant transaminase polypeptide can be a purified polypeptide. Regarding claim 7, Savile, para. [0093], states any engineered transaminase polypeptide can be in a composition. Regarding claim 8-14, Savile, para. [0025], states: “the present disclosure provides host cells comprising the polynucleotides encoding the engineered transaminases or expression vectors capable of expressing the engineered transaminases. In some embodiments, the host cell can be a bacterial host cells, such as E. coli. The host cells can be used for the expression and isolation of the engineered transaminase enzymes described herein.” Saville, para. [0023], directly states that a vector can be an expression vector having one or more control sequences for the expression of the transaminase polypeptide. In view of the preceding, at the time of invention or filing an ordinarily skilled artisan would have been motivated to produce a transaminase as recited in the patented claims in a purified form and/or as part of a composition by encoding the same in a polynucleotide as part of an expression vector associated with at least one control sequence and transformed into an E. coli host cell in order to achieve the advantages of providing and producing the same transaminase as recited in claims 6-14.
Regarding claim 4, patented claim recites a polynucleotide comprising SEQ ID NO: 823 that encodes SEQ ID NO: 824 of the specification. An alignment between recited SEQ ID NO: 4 and the amino acid sequence encoded by SEQ ID NO: 823 is as follows:
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501
652
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Greyscale
As can be seen in the alignment above, the transaminase encoded by SEQ ID NO: 823 has the substitutions/mutations Q191A, I124V, S126A and W136L as to meet and anticipate all of the features of claim 4.
Comment regarding prior art
A search did not reveal any prior art fairly teaching a substitution at position 191 as recited in claim 4. Saville et al. (WO 2010/099501 A1) is considered to be the closest prior art that teaches the sequence of SEQ ID NO: 4 which is itself an engineered transaminase.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD M EPSTEIN whose telephone number is (571)272-5141. The examiner can normally be reached Mon-Fri 9:00a-5:30p.
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
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