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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3 and 11-16, in the reply filed on July 30, 2026, is acknowledged. This Restriction/Election Requirement is made FINAL.
Claims 1-18 are pending. Claims 4-10 and 17-18 are withdrawn from examination as a result of the Restriction/Election Requirement. Claims 1-3 and 11-16 are examined on their merit herein.
Claim Objections
Claim 3 is objected to because of the following informalities: The two wherein clauses appear to be identical and redundant. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 is dependent on claim 11. However, claim 12 does not appear to be further limiting the scope of claim 11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dewey (US20180346917A1, published December 2018) in view of Adams (US20160374387A1, published 2016).
Claim 1 is drawn to cured tobacco leaf from a Nicotiana plant that comprises one or both of the homozygous recessive nic1 and nic2 alleles and comprises BBLa, BBLb, and BBLc genes that are altered, relative to wild type, so as to reduce the activity of BBLa, BBLb, and BBLc or to reduce the expression of a nucleic acid encoding BBLa, a nucleic acid encoding BBLb, and a nucleic acid encoding BBLc, such that the nicotinic alkaloid content of the Nicotiana plant is reduced as compared to a control Nicotiana plant.
Claim 2 is drawn to the cured tobacco leaf of claim 1, wherein the Nicotiana plant comprises both of the homozygous recessive nic1 and nic2 alleles; and/or the leaf comprises a USDA Grade Index that is comparable to or improved as compared to the USDA Grade Index of a cured leaf from a control Nicotiana plant; and/or the leaf comprises a USDA Grade Index of about 60 or higher; and/or the yield of cured leaf is comparable to or increased as compared to a control Nicotiana plant; and/or the nicotinic alkaloid is nicotine.
Claim 3 is drawn to the cured tobacco leaf of claim 1, wherein the tobacco is leaf tobacco, shredded tobacco, cut tobacco, ground tobacco, powder tobacco, tobacco extract, smokeless tobacco, moist or dry snuff, pipe tobacco, cigar tobacco, cigarillo tobacco, cigarette tobacco, or chewing tobacco.
Regarding claims 1 and 11, Dewey teaches RNAi-mediated silencing of BBLa, BBLb, and BBLc genes in flue-cured tobacco cultivar 'K326' and that the RNAi lines exhibit significantly lower nicotine and total alkaloid levels relative to K326. Dewey teaches no significant differences were detected between K326 and any of the RNAi lines for cured leaf quality Overall, and that inhibition of BBL gene expression can give rise to tobacco plants with significantly reduced nicotine while retaining important quality characteristics. Further, Dewey teaches screening burley tobacco breeding line DH98 325-6 for mutations in BBLa, BBLb and BBLc, and that the triple homozygous mutation combination bbla/bbla bblb/bblb bblc/bblc exhibited the lowest levels of total alkaloid accumulation than that for WT DH98-325-6 segregants (Example 1; and Table 2).
Dewey does not teach the cured leaf from tobacco plant also comprising one or both of the homozygous recessive nic1 and nic2 alleles.
Adams teaches tobacco plant and cured leaf, comprising a mutation in one or both Nic1 and Nic2, wherein said tobacco plant is capable of producing leaves having a USDA grade index value of at least about 65%, or …… at least about 95%, or at least about 98% of of the USDA grade index value of leaves of a control plant when grown in similar growth conditions, wherein said control plant shares an essentially identical genetic background with said tobacco plant except said mutation; or wherein said tobacco plant is capable of producing leaves having a USDA grade index value of 60 or more, 65 or more, 70 or more, 75 or more, 80 or more, 85 or more, 90 or more, and 95 or more (e.g., Claims 1-2; Embodiment 4, Embodiment 9); and the nic1/nic2 mutations are homozygous (e.g., E,bodiment 36; Table 12; Table 13; Table 14).
Adams further teaches that the nic1 (and/or nic2) tobacco plant further comprises mutation suppressing the expression or activity of one or more genes encoding BBL, or a QPT (Embodiment 7, e.g.).
Regarding claim 2, Dewey teaches the bblabc triple homozygous mutant with comparable leaf quality of the control plant (see above) and Adams further teaches the nic1/nic2 plant producing cured leaf with comparable quality of the control plant or USDA index of 60 or higher (see above).
Regarding claims 3, and 15, both Dewey and Adams teach leaf tobacco, etc. (Dewey, [0106]; Claim39; e.g.; Adams, Embodiment 25, Claim 16; e.g.).
Regarding claims 11-12, both Dewey and Adams teach tobacco product.
Regarding claims 13-14, Adams teaches the reduction of nicotine by either nic1 or nic2/nic2 of the control plant by at least 50% or 85% (or at least 50% to at least 93%; Table 13, Table 14).
Regarding claim 15, Adams teaches further inclusion of mutation(s) in, e.g., QPT (quinolate phosphoribosyl transferase) and/or PMT (putrescine N-methyltransferase) (Embodiment 7, e.g.).
Therefore, it would have been it would have been obvious to person having ordinary skill in the art, to have combined the teachings of Dewey with Adams to have arrived at cured leaf product from a tobacco plant comprising one or both homozygous nic1 and/or nic2 alleles with homozygous triple bbla/b/c mutant. Such cured leaf would have reduced amount of alkaloids and/or nicotine compared with control material, with comparable leaf quality given the teachings of both Dewey with Adams regarding the chemical properties and leaf quality of both the nic1/nic2 plant and the bbla/b/c plant.
The PHOSITA would have been motivated to combine the nic1/nic2 alleles with bbla/b/c alleles given the teachings of Dewey and Adams, e.g., Adams regarding adding bbl mutations with nic1/nic2, with desired reduction in nicotine levels.
The PHOSITA would have had reasonable expectation of success, e.g., regarding leaf quality and reduction in nicotine/alkaloid contents, given the teachings and success of both Dewey and Adams.
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 1-3 and 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-9 of U.S. Patent No. US 12171177 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:.
The patented claims are drawn to a cured leaf of the Nicotiana plant a modification that reduces the activity or expression of BBLa, BBLb, and BBLc and a homozygous recessive allele of nic1 or nic1 and nic2, , wherein the cured leaf comprises a reduced nicotinic alkaloid content as compared to a leaf of a wild-type control Nicotiana plant or as compared to a Nic1/Nic2 control Nicotiana plant; wherein the Nicotiana plant further comprises reduced expression of QPT, PMT, etc.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
No claims are allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/ Primary Examiner, Art Unit 1663
Prosecution Insights