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 Status
Claims 1-20 are pending and examined.
The rejection of claim(s) 1 is/are under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Regina et al (Patent No. US 9,060,533 B2) is withdrawn as Regina fails to reasonably teach, suggest or provide motivation for the particular mutations as claimed.
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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Claim 1 REMAINS rejected, and claims 2-20 are NOW rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-20, 22 and 27-29 of U.S. Patent No. 12,012,607 B2 (referred to herein as ‘607). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1-20 are is drawn to a Triticum plant or part or cell comprising mutations in starch branching enzyme IIa (SBEIIa)-A, SBEIIa-B, and SBEIIa-D, respectively selected from the group consisting of: SEQ ID NOS: 11910, 11912 and 11916; SEQ ID NOS: 11910, 11912, and 11915; SEQ ID NOS: 11910, 11913 and 11915; and SEQ ID NOS: 11910, 11913, and 11916, wherein the mutations comprise a deletion or an insertion made using a rare-cutting endonuclease that binds to a sequence as set forth in SEQ ID NOS: 6-8, plants and products produced therefrom and a method of making said plant.
‘607 claims a hexaploid Triticum plant comprising at least three deletions induced by a rare cutting endonuclease that is a TALE that binds to SEQ ID NO: 8 in at least three SBEIIa alleles that comprise the sequences as set forth in SEQ ID NO: 11910, 119121 and 11915, plant parts thereof and grain thereof and products thereof, a method for producing said plant that has increased dietary fiber, wherein the plant has increased starch content and thus increased resistant starch, and wherein the grain has increased total protein, and wherein the plant of the method is selfed to generate a plant that is homozygous for the mutations and thus necessarily must germinate in order to practice the selfing step of the method.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the instant invention because ‘607 uses a rare-cutting endonuclease such as a TALE targeting SBEIIa alleles that are encompassed by the instant claims.
Response to Arguments
Applicant traverses the rejection of the claims because the claims have been amended to recite using a rare-cutting endonuclease and because gene editing is unpredictable (Applicant reply dated 13 May 2026, p. 6, ¶ 1).
This argument is unpersuasive because ‘607 claims a TALE nuclease, which is a rare-cutting endonuclease and is identical to the transcription activator-like effector endonuclease, for example, as encompassed by instant claim 5. Moreover, the claims are identical in scope such that one would have a reasonable expectation of success in following ‘607 to arrive at the instant claims.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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