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 1-20 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.
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. US9247706B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are drawn to cured Nicotiana tabacum tobacco material from the N. tabacum plant comprising a first mutation positioned between nucleotide 1872 and 2483 as compared to SEQ ID NO: 4 at a first locus encoding a CYP82E10 nicotine demethylase comprising at least 95% sequence identity to the full length of SEQ ID NO: 4.
The patented claims are drawn to cured Nicotiana tabacum tobacco material or a tobacco product made from a tobacco plant comprising a first mutation in a CYP82E10 nicotine demethylase, resulting in reduced expression or function of said CYP82E10 nicotine demethylase, wherein said first mutation results in a Proline to Serine substitution at amino acid position 381 of CYP82E10 according to SEQ ID NO:2.
As disclosed, mutation corresponding to amino acid 281 is within the nucleic acid sequence region between nucleotide 1872 and 2483 as compared to SEQ ID NO: 4.
Therefore, the claims at issue are not patentably distinct from each other.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-20 of U.S. Patent No. US11304395B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patented claims are drawn to cured Nicotiana tabacum tobacco material or a tobacco product made from a tobacco plant comprising a first mutation in a CYP82E10 nicotine demethylase, resulting in reduced expression or function of said CYP82E10 nicotine demethylase, wherein said first mutation in CYP82E10 nicotine demethylase having a cytosine to thymine mutation at nucleic acid position 1141 according to SEQ ID NO: 1.
As disclosed, at nucleic acid position 1141 according to SEQ ID NO: 1 is within the nucleic acid sequence region between nucleotide 1872 and 2483 as compared to SEQ ID NO: 4.
Therefore, the claims at issue are not patentably distinct from each other.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-9 of U.S. Patent No. US11877556B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patented claims are drawn to cured Nicotiana tabacum tobacco material or a tobacco product made from a tobacco plant comprising a first mutation in a CYP82E10 nicotine demethylase, resulting in reduced expression or function of said CYP82E10 nicotine demethylase, wherein said first mutation first mutation positioned between nucleotide 1872 and nucleotide 2483 as compared to SEQ ID NO: 4.
Therefore, the claims at issue are not patentably distinct from each other.
Conclusion
No claims are allowed.
Claims 1-20 are free of the prior art because there is no prior art reasonably teaching or suggesting a Nicotiana tabacum tobacco plant, seed, or a tobacco product or material comprising a mutant CYP82E10 and/or a second or third mutation in CYP82E4 or CYP82E5 nicotine demethylase. The closest prior art is Dewey (US 20090205072 A1, published on August 13, 2009). Dewey teaches tobacco plant with mutations in CYP82E4 and/or CYP82E5 genes (Example 3). However, Dewey does not teach or suggest CYP82E10, or, tobacco product or material comprising a mutant CYP82E10 with reduced nicotine demethylase activity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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