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 .
Claims 32-51 are pending and examined on their merit herein.
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 32-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-18 of U.S. Patent No. US11299743B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are drawn to a method for producing a tobacco seed comprising
crossing a first tobacco plant having an induced mutation in an endogenous gene, the endogenous gene encoding the amino acid sequence of SEQ ID NO: 8, and wherein the first tobacco plant exhibits reduced expression or activity of a quinolinate synthase protein as compared to a control tobacco plant lacking the induced mutation, with a second tobacco plant, to produce at least one progeny tobacco seed; and selecting a progeny tobacco seed that comprises the induced mutation;
wherein the second tobacco plant comprises an induced mutation in the endogenous gene encoding the amino acid sequence of SEQ ID NO: 8, and wherein the second tobacco plant exhibits reduced expression or activity of a quinolinate synthase protein as compared to a control tobacco plant lacking the induced mutation; wherein the induced mutation results in an amino acid substitution at a position corresponding to position 487 of SEQ ID NO: 8 or position 516 of SEQ ID NO: 8;
wherein the first tobacco plant is a Burley tobacco plant, a dark tobacco plant, a flue-cured tobacco plant, a Maryland tobacco plant, and or Oriental tobacco plant.
Or a method of making a tobacco plant, the method comprising inducing mutagenesis in at least one tobacco cell to produce at least one mutagenized tobacco cell; regenerating at least one tobacco plant from the at least one mutagenized tobacco cell, wherein the at least one tobacco plant comprises an induced mutation in an endogenous gene, the endogenous gene encoding the amino acid sequence of SEQ ID NO: 8, and wherein the at least one tobacco plant exhibits reduced expression or activity of a quinolinate synthase protein as compared to a control tobacco plant lacking the induced mutation.
The patented claims are drawn to method for producing a tobacco seed comprising
crossing a first tobacco plant having an induced mutation in an endogenous gene, wherein the endogenous gene has a sequence 100% identical to SEQ ID NO: 7 with a second tobacco plant to produce at least one progeny seed; and selecting at least one progeny seed from step (a) that comprises said induced mutation; wherein the first tobacco plant exhibits reduced expression or activity of quinolinate synthase as compared to a control plant lacking the induced mutation; wherein the induced mutation provides an amino acid substitution at a position corresponding to the cysteine residue at position 487 or the valine residue at position 516 of SEQ ID NO: 8;
or a method of making a tobacco plant comprising: inducing mutagenesis in a Nicotiana tabacum cell to produce a mutagenized cell; obtaining one or more plants regenerated from the mutagenized cell and identifying at least one plant from step (b) that comprises an induced mutation in an endogenous gene, wherein the endogenous gene has a sequence 100% identical to SEQ ID NO: 7; wherein the at least one plant identified in step (c) exhibits reduced expression or activity of quinolinate synthase as compared to a control plant lacking the induced mutation.
It is noted that the endogenous gene encoding quinolinate synthase is the same in the ‘743 Patent and the instant claims as set forth in the nucleotide sequence SEQ ID NO: 7 and amino acid sequence SEQ ID NO: 8.
Therefore, although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
Claims 32-51 are free of the prior art because there is no prior art reasonably teaching or suggesting the claimed methods of making a tobacco plant having an induced mutation in an endogenous gene encoding SEQ ID NO: 8.
The closest prior arts are Hashimoto et al (PG PUB US 2007/0240728 A1, published on October 18, 2017) and Noguchi et al (US 20130056014 A1, published on March 7, 2013). Hashimoto teaches a method for reducing an alkaloid in a tobacco plant, comprising suppressing a nicotine biosynthesis enzyme quinolinate synthase (QS). However, Hashimoto does not teach tobacco plant or the endogenous QS sequence as set forth in the instant SEQ ID NO: 7. Noguchi et al teaches the factors regulating alkaloid (nicotine, anatabine) biosynthesis in tobacco, encoded by TTF_#80 or TTF_#84 gene. However, the encoded amino acid sequence of TTF_#80 differs from the instant SEQ ID NO: 8 by a string of 5 amino acids. There is no other prior art teaching or suggesting the amino acid sequence 100% identical to SEQ ID NO: 8.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/ Primary Examiner, Art Unit 1663
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