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 Status
Claim 1 is pending and examined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim(s) 1 is/are rejected 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).
Instant claim 1 is drawn to a Triticum plant or part or cell comprising a deletion or insertion in at least two starch branching enzyme II (SBEII) alleles endogenous to the plant that is made using a rare-cutting endonuclease.
Reginal et al claim wheat grain comprising mutations in at least two SBEIIa alleles and further comprising at least two null alleles in the SBEIIb gene (see claims 1 and 2). These mutations may be deletion mutations (see claims 2 and 18-23). The grain may be milled, ground or pearled and come from T. aestivum and comprise increased dietary fiber such as resistant starch (col. 11, ¶ 6; see also col. 28, last ¶; see claim 9).
Regina et al disclose that nucleases, including rare-cutting endonucleases such as ZFN, may be used to introduce deletions in the SBEII alleles that are one or more nucleotide base pairs (col. 25, ¶ 2; see col. 26, last ¶ bridging col. 27). Insertions may be of a similar length (col. 26, last ¶ bridging col. 27). Plants comprising these mutations are non-transgenic or free of any exogenous nucleic acid (claim 7).
Regina et al disclose that plants of the invention encompass plant cells in culture such as protoplasts and immature embryos (col. 27, last ¶ bridging col. 28). Regina et al disclose vectors comprising nucleic acids of interest for transformation and mutation using Agrobacterium and subsequent plant regeneration from cells (col. 43, last ¶; see 44, last ¶; see also col. 50, penultimate and last ¶).
Therefore, a Triticum plant or part or cell comprising a deletion or insertion in at least two SBEII alleles endogenous to the plant that is made using a rare-cutting endonuclease is anticipated by Regina et al.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 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 claim 1 is drawn to a Triticum plant or part or cell comprising a deletion or insertion in at least two SBEII alleles endogenous to the plant that is made using a rare-cutting endonuclease.
‘607 claims a hexaploid Triticum plant comprising at least three deletions induced by a rare cutting 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.
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 TALE targeting SBEIIa alleles that are encompassed by the instant claims.
Conclusion
No claim is allowed.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662