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 .
Status of the Claims
The claims filed 02June2026 are acknowledged and have been fully considered. Claims 1-40 are canceled. Claims 41-60 are new, pending, and examined on the merits herein.
Priority
Applicants’ claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisionals 63145262, 63145263, 63145259 filed 03February2021] and 35 U.S.C. 120 [continuation of 17591188 filed 02February2022 and 18449849 filed 15August2023] is acknowledged. Claims 41-60 have an effective filing date of 03February2021.
Claim Rejections - 35 USC § 112 - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 41-60 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
These claims recite, or refer back to claims that recite, “tobacco” as in, for example, “Cured tobacco material” at claim 41. It is not clear from the specification whether “tobacco” in this context is meant to mean just Nicotiana plants/plant parts or whether “tobacco” is meant to be broader than Nicotiana and encompass, for example, Lobelia inflata plants/parts which have a common name of “Indian Tobacco”1. Please either amend the claims to specify that “tobacco” means Nicotiana plants/parts or provide a claim interpretation on the record (e.g., within Applicants’ return Remarks) so that the scope and meaning of “tobacco” is clear on the record.
Claims 41-60 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
These claims recite, or refer back to claims that recite, “tobacco material”. Further to the indefiniteness rejection above regarding the meaning of “tobacco”, it is not clear what Applicants mean by “material”: at ¶154 on page 86 of the specification it is suggested that “material” means anything from a plant or plant part, but at ¶158 on page 87 of the specification it is suggested that “material” is limited to leaf, stem, bud, flower, or root plant parts. Without clarification from Applicants, the meaning of “material” is unclear. To explain by example, does “tobacco material” encompass a nucleic acid sequence (such as an isolated nucleic acid sequence?)?
Claim 55 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 55 lists many supposed tobacco variety names. While some designations within the list can be found in the prior art (e.g., “Neil Smith Madole”), (1) the use of “TC” numbers/references or other names in parenthesis makes this list (and, hence, the claim) unclear (what does the “TC” number mean? Is the “TC” number or other name in parenthesis a synonym/alternative name?). For example, in certain circumstances there is one common name given but two different “TC” numbers given, which illustrates the lack of clarify surrounding the meaning of the “TC” numbers and how, if at all, the “TC” numbers limit the claimed subject matter. Exemplary unclear recitations include: “Virginia (TI 220), Virginia (TI 273), Virginia (TI 877)”; “KY 160, KY 160 (TC 218)”; “KY (171 (PhPh), KY 171 (TC 475), KY 171 LC, KY 171 NS”; “Little Crittenden, Little Crittenden (TC 476)”; “Madole (TC 478), Madole (TC 479)”; “Basma, Basma (TI 1666)” and (2) other recited names are unclear on their face or not found in the prior art. For example, “yb2” is not found in the prior art (is it perhaps an abbreviation of “Yellow Burley 2”?); “TKF 6400” cannot be found in the art; and it is not clear what “KY 14 x L8 LC” means (is this a reference to a cross?). Given the effort needed to clarify claim 55 sufficient to overcome this rejection, Applicant may wish to consider canceling claim 55.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 41-60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by XU et al. (US 2007/0199097 published 23August2007).
As an initial matter, please note the manner in which these claims are written: the claims are directed toward “cured tobacco material from a modified tobacco plant” and the structural limitations regarding nucleic acid and/or amino acid sequences, etc., (i.e., the structural features recited in claims 41-51) limit the modified tobacco plant (NOT the claimed “cured tobacco material”). To that end, note lines 1-2 of claim 41 state “… wherein the modified tobacco plant comprises …” (it does not say “… wherein the cured tobacco material comprises …”). Therefore, there are few (if any) meaningful structural limitations on the claimed “cured tobacco material”. For example, there is no requirement that the “cured tobacco material” comprise promoter sequences SEQ ID NO: 46 or 47 operably linked to a heterologous polynucleotide encoding a polypeptide. It is recommended that these claims be amended so that the claimed “cured tobacco material”, not just the plant from which such material originates, comprises SEQ ID NO: 46 or 47 operably linked to a heterologous polynucleotide encoding a polypeptide (as well as the other structural bits recited in claims 41-51).
XU et al. teach cured Nicotiana (i.e., “tobacco”) plants and parts (i.e., “material”) including those which are flue-cured and/or from Burley variety “Neal Smith Madole” as well as “products” comprising the same2 [claims 40-5558-60]. XU et al. teach using male3 or female4 sterile plants [claims 56-57].
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 41-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-12, 14, 15-17 of U.S. Patent No. 12,351,809 (from Appl. No. 18449849). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of US Pat. No. 12,351,809 teach “cured tobacco material” (such as flue-cured Nicotiana plant parts, e.g., leaf or stem parts) from or comprising the promoter SEQ ID NO: 46 or 47 operably linked to a sequence that encodes cis-abienol synthase ISOFORM1 or ISOFORM2 [claims 41-54].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
1 See, e.g., “Lobelia inflata” within the Lady Bird Johnson Wildflower Center plant database, available at https://www.wildflower.org/plants/result.php?id_plant=LOIN (last visited 13August2026, 5 total pages).
2 XU et al. at claims 32-35 as well as 17 on pages 18-20; page 8 (e.g., “tobacco dust” and “tobacco stem” at ¶56).
3 XU et al. at claims 30-31 on page 20 as well as ¶43 on pages 6-7.
4 XU et al. at ¶43 on pages 6-7.
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