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
The amendments received on June 26, 2026, have been entered. Claims 1-28 and 30-34 are pending and are examined in this Office Action.
Claim Interpretation
Claims 4 and 5 are directed to a seed grown from the plant of claim 1 and a plant grown from said seed. Claim 4 does not specify how the plant of claim 1 was pollinated, therefore, claim 4 is inclusive of F1 hybrid seeds produced by pollinating the plant of claim 1 with pollen from a different plant as well as including seeds from self-pollinating the plant of claim 1. Because the plant of claim 1 is required to have the same genetic makeup as lettuce variety NUN 09185 LTL, it is understood that the seed of claim 4 and the plant of claim 5 will necessarily each comprise at least one copy of each chromosome identical to the chromosomes in variety NUN 09185 LTL.
Claims 7 and 8 are directed to a tissue culture or cell culture of regenerable cells of the plant or plant part of claim 1. Because the plant and plant part of claim 1 are required to have “the same genetic makeup as lettuce variety NUN 09185 LTL”, it is understood that the tissue culture and cell culture claimed in claims 7 and 8 are required to have the same genetic makeup as lettuce variety NUN 09185 LTL.
Claims 16 and 17 are directed to F1 hybrid lettuce seeds and plants produced by crossing the plant of claim 1 with a different parent plant. Because the plant of claim 1 is required to have the same genetic makeup as lettuce variety NUN 09185 LTL, it is understood that the seed of claim 16 and the plant of claim 17 will necessarily each comprise at least one copy of each chromosome identical to the chromosomes in variety NUN 09185 LTL. Because claims 16 and 17 require that the seed/plant is a hybrid, it is understood that the plant of claim 1 is crossed with a plant having a different genetic background, otherwise the plant would be inbred rather than hybrid (i.e. if the plant is crossed with another plant that is also of variety NUN 09185 LTL).
Claim 24 is directed to a lettuce plant having a single locus conversion and otherwise having all of the morphological and physiological characteristics of the plant of lettuce variety NUN 09185 LTL. Because the claimed plant is produced by crossing the plant of claim 1 with a second plant and backcrossing to lettuce variety NUN 09185 LTL, it is understood that the claimed lettuce plant will have at least one copy of each chromosome identical to the chromosomes in variety NUN 09185 LTL, other than the single locus which has been converted and the second copy of each chromosome will be predominantly NUN 09185 LTL DNA because of the repeated backcrossing and selection.
Claim 31 is directed to a lettuce head or a lettuce leaf produced by growing the plant of claim 1 until it develops at least a leaf or head and collecting the leaf or head. Because the plant of claim 1 is a whole plant having the same genetic makeup as lettuce variety NUN 09185 LTL, it is understood that the claimed leaf or head will also have the same genetic makeup as lettuce variety NUN 09185 LTL. Claim 32 is interpreted to be a combination of a container and a lettuce head or leaf, and the lettuce head or leaf inside the container has the same genetic makeup as lettuce variety NUN 09185 LTL for the same reason as claim 31.
Objections and Rejections That are Withdrawn
The objections to claims 13, 14, and 34 for reciting “selfing” and plant “with itself” are withdrawn in light of Applicant’s amendments to the claims.
The objection to claims 24 is withdrawn in light of Applicant’s amendments to the claims.
The portion of the written description rejection directed towards the lack of a breeding history in the instant specification is withdrawn in light of Applicant’s amendments to the specification that identify the parent plants used in the initial cross for breeding the instant variety.
The rejection of claim 27 under 35 USC 112(a) for inadequate written description is withdrawn in light of Applicant’s amendments to the claim which limit the number of mutated target genes to a single mutated target gene.
Claim Objections
Claims 15, 25, 27, and 34 are objected to because of the following informalities:
Claim 15 recites “wherein at the first parent lettuce plant” in the third line, and this is grammatically incorrect. Applicant is advised to delete “at”.
Claim 25 recites “gene editing in lettuce plant” in line 2, and this is missing an article in front of “lettuce plant”.
Claim 27 recites “comprising a single mutated target gene and otherwise has” and this is grammatically incorrect. Applicant is advised to replace “has” with - - having - - to match the verb tense of “comprising”.
Claim 34 recites “crossing the plant of claim 1 or with a second lettuce plant” in part (a), and this is grammatically incorrect. Applicant is advised to delete “or”.
Claim 34 recites “crossing the progeny plant or a second lettuce plant to produce seed of a progeny plant of a subsequent generation” in part (b), and this is technically incorrect because crossing a second lettuce plant would not produce seed of a progeny of a subsequent generation. Applicant is advised to replace “or a” with - - with - - . Part (c) has the same issue.
Appropriate correction is requested.
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 1-28 and 30-34 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on June 26, 2026, have been fully considered but were not found to be persuasive.
Claim 1 is directed to a whole plant, plant part, or seed having the same genetic makeup as lettuce variety NUN 09185 LTL, and it is unclear if this “whole plant” is a plant of variety NUN 09185 LTL or if it only has the same “genetic makeup” as lettuce variety NUN 09185 LTL. “Genetic makeup” is understood in the art to be the genotype of an organism which includes the entire genome of the organism. If the whole plant is intended to be a plant of variety NUN 09185 LTL have the same genetic makeup as the deposited seeds, then Applicant is invited to amend the claim to clarify (i.e. a - - whole plant of lettuce variety NUN 09185 LTL having the same genetic makeup as seeds deposited under Accession Number NCIMB 43875 or a plant part or seed having the same genetic makeup as the deposited seeds - - ). Otherwise it is unclear why the claim reads as if having the same genetic makeup is a different scope compared with being a member of the variety.
Claims 14, 20-22, 28, 33, and 34 each recite the limitation "the plant of lettuce variety NUN 09185 LTL". There is insufficient antecedent basis for this limitation in the claims because claim 1 does not recite a plant of lettuce variety NUN 09185 LTL, rather it is directed to a plant having the same genetic makeup as lettuce variety NUN 09185 LTL. It is noted, that if Applicant were to amend as suggested in the previous paragraph, then this issue would be addressed.
Claim 6 is directed to a lettuce plant, or a part thereof, having all the physiological and morphological characteristics of the plant of claim 1 when grown under the same environmental conditions. This requires the plant to have the same phenotype by does not require the plant to have the same genotype, nor does it require the plant to be a member of variety NUN 09185 LTL. It would logically flow that having ALL of the physiological and morphological characteristics would require the same genetic makeup because these characteristics are a function of the underlying genetics. If the claim is directed to a plant or part thereof with the same genetic makeup, then the claim does not further limit claim 1 from which it depends (see rejection under 35 USC 112(d), below). If the claim is directed to a plant having all the physiological and morphological characteristics that does NOT have the same genetic makeup, then there is an issue with written description (see rejection under 35 USC 112(a), below).
In addition, for claim 6, it is unclear how a “part thereof” can have all of the physiological and morphological characteristics of the plant of claim 1. For example, if the plant of claim 1 has white seeds, how can a leaf have white seeds?
Claims 25-27 are rejected because it is unclear if the lettuce plant is required to have the same genetic makeup as lettuce variety NUN 09185 LTL with the exception of one single mutated target gene relative to the deposited seeds. This is because claim 27 is produced by targeted gene editing in a lettuce plant or plant part of lettuce variety NUN 09185 LTL (claim 25), and claim 25 does not specify that the started material (lettuce plant prior to editing) is required to have the same genetic makeup as the seeds deposited for NUN 09185 LTL.
The following definition is provided for the word “plant”:
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(Spec 8)
This means that any time the word “plant” appears in a claim, it is inclusive of a whole plant, plant part, or derivative of a plant/plant part, and it is NOT required to have the same genetic makeup as the plant from which it is obtained. This raises indefiniteness for claims 25-27.
Arguments
Applicant argues that claim 1 was amended to recite “whole plant, plant part, or seed of lettuce variety having the same genetic makeup as lettuce variety NUN 09185 LTL” thereby rendering the rejection moot (Resp 8). This is not the actual amendment that was submitted. The claim was amended to recite “whole plant, plant part, or seed having the same genetic makeup as lettuce variety NUN 09185 LTL”. The amended claim does not make it clear if the whole plant, plant part, or seed is required to be a whole plant, plant part, or seed of lettuce variety NUN 09185 LTL, see rejection above.
There are additional issues with dependent claims that are addressed, above.
Inadequate Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6, 14, and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Claim 6 is directed to a lettuce plant, or a part thereof, having all the physiological and morphological characteristics of the plant of claim 1 when grown under the same environmental conditions. It is unclear if the claimed plants or plant parts are required to have the same genetic makeup as the seeds deposited under Accession Number NCIMB 43875.
Applicant has described lettuce variety NUN 09185 LTL, in part by depositing a representative sample of seed with the NCIMB, and in part by including three trait tables (Spec 45-51). Presumably the plants grown to collect the data for these traits tables are from the same batch of seeds as the seeds deposited with the NCIMB with no changes to the genetics between the deposited seeds and the seeds used for collecting the data.
Applicant has not described any plants having all the physiological and morphological characteristics with variety NUN 09185 LTL that do not share the same genetic makeup as variety NUN 09815 LTL and the deposited seeds.
Claim 14 is directed to a progeny of the lettuce plant of claim 1, obtained by crossing the plant of lettuce variety NUN 09185 LTL with another lettuce plant. “Progeny” does not provide any limitations as to how many generations removed the claimed progeny plant can be from variety NUN 09185 LTL, and the method of making does not limit the method of making to only one single cross. For this reason, the claimed progeny could be many generations removed from the deposited seeds and could have been generated by a breeding method that included many additional crosses to “another” lettuce plant. For this reason, claim 14 encompasses an extremely large genus of plants which could be distally related to the deposited seeds of the instant variety. This large genus of plants has not been adequately described.
Claim 21 is directed to a lettuce plant produced by a method comprising transforming the plant of lettuce variety NUN 09185 LTL with a transgene that confers a desired trait, wherein the transformed plant contains the desired trait and otherwise all of the morphological and physiological characteristics of the plant of lettuce variety NUN 09185 LTL. Because the method uses the open language of “comprising”, the claimed lettuce plant could comprise an unlimited number of transgenes each of which alter one of the characteristics of lettuce variety NUN 09185 LTL. Each transformation event will insert the transgene into an unknown region of the genome and is likely to cause some “position effects” that alter a characteristic of lettuce variety NUN 09185 LTL. With no limit for how many characteristics can be altered, the lettuce plant claimed in claim 21 is actually an extremely large genus of transgenic plants. Applicant was not in possession of a representative number of species of the genus, and the genus has not been adequately described because any given characteristics of lettuce variety NUN 09185 LTL can be altered. For this reason, the genus of plants encompassed by claim 21 is not adequately described.
Failure to Further Limit
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.
Claims 6 and 12 are 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. . 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.
Each of claims 6 and 12 ultimately depend from claim 1, and each of the claims comprise the exact same scope as claim 1. While it is true that claim 1 is directed to a “whole plant, plant part, or seed”, whereas claims 6 and 12 are each directed to “a lettuce plant, or a part thereof”, this difference does not alter the scope encompassed by the claims because a seed is a “part” of a plant.
For claim 6, it is unclear if claim 6 is required to have the same genetic makeup as lettuce variety NUN 09185 LTL (see rejection under 35 USC 112(b), above). If claim 6 does not have the same genetic makeup, then there is a written description rejection, see above, and if claim 6 does require the same genetic makeup, then it is identical in scope to claim 1 and therefore fails to further limit claim 1.
For claim 12, the claimed plant or part thereof is required to have all of the physiological and morphological characteristics of lettuce variety NUN 09185 LTL, and the claimed plant or part thereof is produced by vegetatively propagating the plant or a part of lettuce variety NUN 09185 LTL. This necessarily means that the plant or part thereof shares the same genetic makeup as lettuce variety NUN 09185 LTL, and therefore claim 12 is identical in scope to claim 1 and fails to further limit claim 1.
Claim Rejections - 35 USC § 102/103
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. Applicant’s arguments in the response received on Oct. 24, 2025, have been fully considered but were not found to be persuasive.
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.
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.
Claim(s) 14 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Munoz, J. F. (US Pre-Grant Publication US 2019/0223400 A1; published on July 25, 2019). Applicant’s arguments in the response received on June 26, 2026, have been fully considered but were not found to be persuasive.
The claims are directed to a lettuce plant derived from lettuce variety NUN 09185LTL by either crossing to another lettuce plant or by transforming lettuce variety NUN 09185LTL with a transgene. As discussed, above, in the written description rejection, each of these claims encompasses a large genus of plants which are not required to retain the characteristics of lettuce variety NUN 09185LTL or the genetics of lettuce variety NUN 09185LTL.
Munoz teaches lettuce variety NUN 06193 LTL (abstract). Comparing Munoz’s Tables 1 and 2 (Munoz 13-15) with the instant Trait tables 1-3 (Spec 45-51), many of the traits are the same: white seeds, semi-erect leaf attitude, green leaves, thin leaves, absence of blistering, and loose heads.
Munoz teaches traditional breeding techniques that include crossing, selfing, and selection (Munoz 4). Munoz claims their lettuce plant further comprising a transgene conferring the same list of traits as claimed in the instant claims (Munoz claim 16). Munoz does not limit the number of transgenes that could be introduced, therefore, the genus of plants encompassed by Munoz’s claim 16 is extremely large.
For the obviousness portion of this rejection: for some of the claims, Munoz has taught and claimed the claimed material, but Munoz has not reduced it to practice. The Examiner has determined that all claims have been anticipated because there is no legal requirement for the prior art to have reduced to practice an invention in order to anticipate it. However, in the event there are some claims where the Examiner could be persuaded they were not fully envisioned, contemplated, and conceived in the prior art, then all claims are fully obvious, because the prior art clearly teaches and suggests all elements of every claim.
Arguments
Applicant argues that the rejection is rendered moot (Resp 9). This is not persuasive, however, because the response did not amend claims 14 and 21 to limit the scope of the plants being claimed in a way that would render this rejection moot (see above).
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 14 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,874,072; issued on Dec. 29, 2020. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are quite broad and do not include any limitations that would exclude the lettuce plants claimed in the ‘072 patent (see analysis in 102/103 rejection, above). Applicant’s arguments in the response received on Oct. 24, 2025, have been fully considered but were not found to be persuasive.
The double patenting rejection is over the issued patent for the same application that was published for Munoz which was relied upon for the 102/103 rejection. Therefore, the analysis is identical. The only difference is that the issued patent had three new claims added relative to the pre-Grant publication, therefore, more of the instant claims were covered by the issued patents claims.
Arguments
Applicant argues that the rejection is rendered moot (Resp 9). This is not persuasive, however, because the response did not amend claims 14 and 21 to limit the scope of the plants being claimed in a way that would render this rejection moot (see above).
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
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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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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
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