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 21January2026 are acknowledged and have been fully considered. Claims 1-25 are pending; claims 1-3, 5-9, 11-15, 17, 19-21, 23 are currently amended; claims 4, 10, 16, 18, 22, 24-25 are original. Claims 1-25 are examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 63426900 filed 09November2022] is acknowledged. Claims 1-25 maintain an effective filing date of 09November2022.
Withdrawn Objections and/or Rejections
Objections and/or rejections made of record in the nonfinal office action dated 13November2025 that are not otherwise discussed herein are withdrawn. In particular:
RE ¶ 4: The objection to the specification is withdrawn in view of the amendment to the title;
RE ¶¶ 6-10: The objections to the claims are withdrawn in view of the claim amendments;
RE ¶ 12-13: The indefiniteness rejections are withdrawn in view of the claim amendments;
RE ¶ 14: The rejection is withdrawn in view of the claim amendments (which are consistent with what was suggested by the Office); and
RE ¶ 16: The Deposit rejection is withdrawn in view of the following statements by Applicant’s representative (page 14 of the Remarks dated 21January2026):
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Specification
The disclosure REMAINS objected to because of the following informalities: further to the Written Description (Breeding History) rejection herein below, the specification is objected to because it does not sufficiently describe the breeding history of tomato lines FIP-9S18-0174 or SVTG6217 (please note that plants/parts of tomato line FIP-9S16-0361 are not currently being claimed).
Appropriate correction is required.
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 15 and 17 (and also claims 16 and 18 which refer thereto without correcting the issue) REMAIN 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.
The format of these claims suggest that the claimed tomato plants are represented by the deposited seed. However, these claims are directed toward tomato plants characterized by having introduced any number of transgenes or locus conversions into a plant/part of tomato line FIP-9S18-0174 (please note that “further comprising” language). For at least this reason, the deposited seed does not represent the claimed tomato plants and, in any event, the genomic structure represented by deposited seed cannot “further comprise” a transgene or locus conversion because the structure of deposited seed is fixed. The amendments filed 21January2026 are not remedial of this problem at least because the set of chromosomes which “further comprises a transgene” originates from a plant/part of tomato line FIP-9S18-0174 (the amendment does not remedy the issue = it remains the recommendation by the Office that “derived from” language should be used to clarify the claims).
[Copied from the Nonfinal →] It is recommended that these claims be amended so that they are directed toward tomato plants derived from a plant of tomato line FIP-9S18-0174 characterized by a tomato plant/part of tomato line FIP-9S18-0174 into which a transgene/single locus conversion was introduced, wherein the derived plant comprises the transgene/single locus conversion “and all of the morphological and physiological characteristics of a plant of line FIP-9S18-0174 when grown under the same environmental conditions” and a representative sample of seed of said line was deposited under NCMA Accession No. 202210019. Alternatively, Applicant may wish to consider capturing the subject matter of claims 15-16 and 17-18 via product-by-process claims (e.g., like claims 13-14 for introducing a transgene into a plant/part of FIP-9S18-0174, perhaps Applicant wants to introduce a method claim for introducing a single locus conversion into a plant/part of FIP-9S18-0174 and then introduce a product-by-process claim depending therefrom—in that scenario, claim 15 may be deemed redundant of claim 14 and, therefore, may be canceled?).
Response to Applicant’s Remarks 21January2026:
Applicant traverses this rejection (pages 8-9) with a focus on the “first set of chromosomes” language.
Applicant appears to misunderstand the problem with the claim language—a genomic structure, plant, or plant part cannot be both “of” a particular cultivar/line and further comprise a transgene or locus conversion because the genomic structure of the cultivar/line is fixed.
Claim Rejections - 35 USC § 112 – Scope of Enablement
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 4, 6, 8 are or remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while (subject to perfecting the deposit) is enabling for using the deposited hybrid seed (including growing plants therefrom, transformation or gene editing thereof, and clonal propagation therefrom), does not reasonably provide enablement for making such hybrid seed or performing backcross steps (which is necessary to, for example, introduce a locus conversion into a plant/part of hybrid tomato variety SVTG6217 as well as returning to “all of the morphological and physiological characteristics” of a plant of hybrid tomato variety SVTG6217 following an outcross). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
As amended 21January2026, claims 4, 6, and 8 are now directed toward plants or plant parts of hybrid tomato line SVTG6217, which is the feature of the claims upon which the enablement issue is based (one cannot make the plant/part of hybrid tomato line SVTG6217 without access to both inbred parent plants and currently only access to a plant/part of the FIP-9S18-0174 is contemplated via deposit—Applicant has not provided any suggestion that access to plants/parts of the other inbred parent line FIP-9S16-0361 is or will be provided).
[Copied from the Nonfinal →] This rejection is based on the fact that Applicant has only deposited hybrid SVTG6217 seed and these claims are directed toward products or methods that can only be made/practiced via access to seed of the inbred parent varieties.
In particular, while a skilled artisan may grow a plant of hybrid tomato variety SVTG6217 by planting the deposited hybrid seed, that artisan cannot make/reproduce seed of hybrid tomato variety SVTG6217 because hybrid seed do not breed true to type (meaning that seed generated from hybrid tomato variety SVTG6217 will produce plants with materially different structure and function/phenotype than what is described of hybrid tomato variety SVTG6217 at Table 11—a skilled artisan needs to cross the inbred parents to regenerate F1 hybrid seed2). To do so, a skilled artisan needs access to the seed of each inbred parent variety. Further, products are claimed or recited (i.e., within method steps) which are believed to require backcross steps to make (such as an outcrossed plant returning to the characteristics of a plant of hybrid tomato variety SVTG6217, introducing a locus conversion which is done via outcrossing, and even introducing a transgene which may be done via outcrossing). Absent evidence to the contrary, conducting such backcross steps would require access to (use of) the inbred parent varieties3.
Because the (assumed) inbred parent line FIP-9S16-0361 does not appear to be publicly available (via Deposit practice or other means); it would require undue trial and error experimentation for a skilled artisan to make and/or use the full scope of subject matter being claimed.
It would be remedial of this rejection if Applicant either (1) explains how access to the (assumed) inbred parent line FIP-9S16-0361 is already available, (2) deposits seed representative of the (assumed) inbred parent line FIP-9S16-0361, or (3) deletes the rejected claims.
Response to Applicant’s Remarks 21January2026:
Applicant traverses this rejection on the grounds that it would not require “undue” trial and error experimentation to make the claimed subject matter (see page 10, 12-14) and/or that the claims are amended to refer back to claims which were not rejected and, therefore, the amended claims should no longer be rejected here (pages 10-11).
Applicant’s argument regarding “undue” trial and error experimentation is not persuasive(including Exhibit B) in view of plant genomics and what is/was known regarding hybrids (see the rejection). Applicant’s argument regarding claim amendments is also not persuasive—the problem underlying this rejection regards claiming hybrid plants/parts and the claims still recite that subject matter (importantly, they recite hybrid plants/parts without an accompanying disclosure of how both parents are, or will be made, accessible).
Claim Rejections - 35 USC § 112 – 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 1, 15, and 17 (therefore, also claims 2, 7-14, 16, 18-25) REMAIN 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.
Claim 1 regards a plant having “at least a first set of chromosomes of (assumed inbred) tomato line FIP-9S18-0174”. Claim 15 adds that the plant “further comprises a transgene”. Claim 17 adds that the plant “further comprises a single locus conversion”. The rest of these claims either refer back to the products of claims 1, 15, 17, or require them for practicing the claimed method.
The specification only describes a plant/part of (assumed inbred) tomato line FIP-9S18-0174 and FIP-9S16-0361 as well as a plant/part of hybrid progeny tomato line SVTG6217 (please see Tables 1 and 2 in the specification as well as the parentage/breeding history information submitted as a “Transmittal Letter” on 12April2024).
Neither the specification nor the prior art describe the structure (i.e., genomic structure) or morphological and physiological characteristics of a plant/part that has “a first set of chromosomes” of (assumed inbred) tomato line FIP-9S18-0174, let alone one that “further comprises” a transgene or single locus conversion.
Without more information from Applicant, a skilled artisan would not reasonably recognize Applicant as being in possession of the full metes and bounds of these claims at the time this application was filed.
It is recommended that the “at least a first set of chromosomes” concept be deleted from the claims.
Response to Applicant’s Remarks 21January2026:
Applicant traverses his rejection because the “entire genetic contribution tomato line FIP-9S18-0174 is described in the specification by way of deposit” (Remarks at page 15, repeated argument throughout pages 15-17).
This is not persuasive because the claims scope is much broader than what is/was deposited (these claims refer to just a “first set of” chromosomes whereas the deposit would comprise all chromosomes).
Claims 15, 17 (therefore, also claims 16 and 18 which refer thereto without correcting the issue) REMAIN 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.
As amended 21January2026, claim 14 is removed from this rejection.
Claims 15 and 17 regard a tomato plant generated by introducing any number of (no upper limit) transgenes or single locus conversions into a plant/part of claim 1. Even if claim 1 is limited to a plant/part of inbred tomato line FIP-9S18-0174 (see the Written Description rejection immediately above), the plants of claims 15, 17 may be modified structurally via transgenes or locus conversions to a point that they have no material resemblance to the structure/genomic structure or morphological and physiological characteristics of a plant/part of FIP-9S18-0174.
Because the specification only describes a plant/part of FIP-9S18-0174 (not one such plant “further comprising” an unlimited number of transgenes or locus conversions) and because the specification is not supplemented by the prior art; a skilled artisan at the time this application was filed would not reasonably believe Applicant was in possession of the full metes and bounds of these claims.
It is recommended that claims 15, and 17 be amended to recite that the claimed plant comprises the transgene/single locus conversion “and all of the morphological and physiological characteristics of a plant of tomato line FIP-9S18-0174 when grown in the same environmental conditions”.4
Response to Applicant’s Remarks 21January2026:
It appears as though the remarks at pages 15-17 (part (G)(1)) also apply to this rejection. Please see above.
Claims 2, 5, and 8 REMAIN 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.
As amended 21January2026, claims 2 and 5 refer to deposited seed. This amendment is not sufficient to overcome this rejection because Applicant has neglected to say that the deposited seed is representative of the claimed seed. Claim 8 is not amended to tether the claimed plant to that of the FIP-9S18-0174 line. Please note that the plant of claim 8 still has any genomic structure and need not share any genomic structure with that of a plant of the FIP-9S18-0174 line.
[Copied from the Nonfinal →] To the extent that claim 1 is directed toward a plant of tomato line FIP-9S18-0174, claims 2 and 5 are directed toward seed that produces a plant of tomato line FIP-9S18-0174 and claim 8 is directed toward a plant (with any structure/genomic structure) that has “all of the [morphological and physiological] characteristics” of a plant of tomato line FIP-9S18-0174 when grown under the same environmental conditions.
Please note that claims 2 and 5 do not say that the seed is represented by deposited seed. Please also note that claim 8 does not require that the plant share any structure/genomic structure with that of line FIP-9S18-0174 (i.e., the claimed plant is not “of tomato line FIP-9S18-0174”).
The only seed described by the specification that “produces a plant of line FIP-9S18-0174” is that represented by the sample of seed deposited under NCMA Accession No. 202210019. Similarly, the only plant described by the specification that has “all of the” characteristics listed in Table 2 of the specification5 (i.e., the characteristics of a plant of line FIP-9S18-0174) is a plant of that line (i.e., a plant of line FIP-9S18-0174).
Without more information, a skilled artisan at the time this application was filed would not reasonably recognize Applicant as having been in possession of any other seed which produces a plant of tomato line FIP-9S18-0174 or in possession of any other plant having the characteristics listed in Table 2.
Please amend claims 2 and 5 so that the structures/genomic structures of the claimed seed are tethered to a deposit such as by specifying that “a representative sample of seed having been deposited under NCMA Accession No. 202210019”. Please amend claim 8 to that the tomato plant is of tomato line FIP-9S18-0174 and please correct the reference to characteristics as follows “… all of the morphological and physiological a [[the]]plant of tomato line FIP-9S18-0174when grown in the same environmental conditions.” (correcting for consistency with claim 11 and adding a reference to growth conditions as is stated in the specification at ¶40 on page 25).
Response to Applicant’s Remarks 21January2026:
Applicant appears to assert that the claim amendments are sufficient to overcome the issue(s) underlying this rejection (Remarks at page 18).
That is not persuasive for the reasons stated above.
Claims 1-25 REMAIN 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.
These claims are directed toward plants/plant parts of tomato lines FIP-9S18-0174 or SVTG6217 or to methods of using them. For the reasons already stated above, representative seed of said lines must be (1) obtainable by a reproducible method set forth in the specification or (2) otherwise be readily available to the public. If such seed is neither (1) nor (2); then (3) a deposit of such seed in compliance with 37 CFR 1.801-1.809 may satisfy the requirements of 35 U.S.C. § 112(a). Because the present specification does not (1) describe a reproducible process to obtain FIP-9S18-0174 or SVTG6217 seed and (2) the FIP-9S18-0174 or SVTG6217 seed does not appear to be otherwise publicly available; the Office believes (as is confirmed herein above via the Scope of Enablement and Deposit Rejections) that (3) a deposit in compliance with 37 CFR 1.801-1.809 of FIP-9S18-0174 or SVTG6217 seed is needed for this application (37 CFR 1.809(a)). To that end, please see the Scope of Enablement and Deposit Rejections hereinabove.
However, simply depositing seed with an acceptable depository is not enough for compliance with 37 CFR 1.801-1.809: the specification must also provide “a description of the deposited material sufficient to specifically identify it and to permit examination” (37 CFR § 1.809(d)(3)).
MPEP § 2163(I) explains that:
“The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted." [emphasis added, citing Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,876 (August 22, 1989), hereinafter “Final Deposit Rules”]
"The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." [emphasis added, citing Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,880 (August 22, 1989)]
“Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description.” [emphasis added, citing In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985) and the Final Deposit Rules at 34,880]
“As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.” [emphasis added, citing the Final Deposit Rules at 34,880].
The MPEP also provides practical advice for determining what level of detail is sufficient to adequately describe a product: enough details so that a skilled artisan may distinguish the product from other products. In particular, and in the case of the product being a chemical compound, MPEP § 2163(II)(A)(3)(a)(i) explains that an Applicant must provide “identifying characteristics that distinguish the claimed invention from other materials” [emphasis added, citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406] and, said another way, that “the inventor be able to define it so as to distinguish it from other materials” [emphasis added, citing citing Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200 at 1206 (Fed. Cir. 1991)]. Looking back at the quoted passages from MPEP 2163(I), this makes sense—a third party cannot “[resolve] questions of infringement” and an examiner cannot “compare the identity and characteristics of the deposited biological material with the prior art” if the specification does not provide enough information about the product (i.e., “identifying characteristics”) so that it can be distinguished from other products (e.g., distinguished from the third party’s products or products in the prior art including Applicant’s own other products).
It is recognized in this art that to distinguish a plant of one variety from a plant of a second variety, a skilled artisan needs a description of both (a) the morphological and physiological characteristics (“traits”) of each variety and (b) the breeding history (also referred to as “parentage” or “pedigree”) of each variety.6
The current specification describes (a) the morphological and physiological characteristics of a plant/part of tomato line FIP-9S18-0174 and of a plant/part of tomato line SVTG62177, but the current specification does not describe (b) the breeding histories of tomato lines FIP-9S18-0174 or SVTG6217.
To be clear, the only description provided by the specification regards only SVTG6217 (not FIP-9S18-0174) and is the following (from ¶28 on page 9 of the specification).
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One will note that material information is not given (such as identifying details about either parent plant, e.g. a name/identification number and where, if at all, they may be accessed by the public; as well as information about the lines being claimed here such as whether lines FIP-9S18-0174 or SVTG6217 are first generation progeny or other).
Without more information from Applicant, the current specification does not provide enough information to distinguish a plant/part of the claimed variety from a plant/part of a second variety (MPEP § 2163(II)(A)(3)(a)(i)). Therefore, the Office believes that the current specification does not provide a description that can “aid in the resolution of questions of infringement” or otherwise meet the guidance set forth in MPEP § 2163(I). In conclusion, the Office believes that the current specification does not provide “a description of the deposited material sufficient to specifically identify it and to permit examination” as is required by 37 CFR § 1.809(d)(3).
Because all of claims 1-25 require the deposited seed, and because the current specification does not evidence compliance with 37 CFR § 1.809(d)(3) (because it fails to provide both (1) an actual deposit of representative seed (as noted in the Scope of Enablement and Deposit Rejections herein) and (2) “a description of the deposited material sufficient to specifically identify it and to permit examination”), these claims are rejected for a lack of Written Description.
To overcome this rejection, Applicant must amend the specification (or drawings and specification) to provide the breeding history used to develop tomato lines FIP-9S18-0174 and SVTG6217. Please note that the description, at a minimum, should specifically identify the parent plants (e.g., by a name such as a variety name in a patent document or other identification number such as a deposit accession number, germplasm identification number, or Plant Variety Protection number) and provide some context regarding the crosses/backcrosses and selection steps that were conducted therefrom to arrive at the claimed variety. Some acceptable breeding history disclosures may be found at, for example: the specification for Appl. No. 175870368 at ¶196 on page 60 of the specification; the specification for Appl. No. 149960939 at line 15 on page 5 to line 4 on page 7 of the specification; the specification for Appl. No. 1526605210 at line 13 on page 10 to line 20 on page 11 of the specification; and the specification for Appl. No. 1745543211 at ¶¶121-124 on page 45 of the specification. These are just examples, Applicant should please tailor the language provided in response to this rejection to the particulars of this application’s subject matter. Please note that with respect to unpublished parent plants (that have not and will not be publicly available), the breeding history within the specification should make their unpublished status clear and then the specification need not provide any other names/identifiers (as in the wheat XW13W Appl. No. 15266052, the specification explains that at least one of the parents is “a proprietary variety not commercially available” and thereafter refers to plants of that line as “proprietary variety”; another example, which also happens to be in the context of wheat, is that for wheat 6PEMZ97B Appl. No. 17455432 where the breeding history gives identifying names/numbers for two unpublished parents and then explicitly states that they have “not been publicly disclosed”). Please take note that “unpublished” is different than “proprietary” (which denotes ownership)—in these scenarios, it is material that the specification describes unpublished parent plants as just that (not publicly available). In the case of plants that do not have a name/identifier (e.g., a wild type parent plant), the breeding history may describe where the plant was obtained (e.g., in the case of a wild type parent plant, the region of the world from which it was obtained or the depository from which its seed/germplasm was obtained) and material traits of that plant or selection criteria used to arrive at the claimed progeny plant therefrom (i.e., so that it is clear from the breeding history how the claimed progeny differs from the unnamed/unidentified parent plant; which is especially important when the unnamed/unidentified parent plant is a wild type plant).
It is noted that Applicant provides the following in the Transmittal Letter dated 12April2024 (i.e., not within the specification itself):
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However, this information is insufficient to overcome this rejection because (1) it is not within the specification itself (it is merely within the file wrapper)—as Applicant no doubt knowns, it is the specification which must provide Written Description and Enablement—and (2) the above-captured statement by Applicant says certain lines are “proprietary” which, as said hereinabove, is materially different than confidential. If Applicant has, and intends to maintain, parental lines confidential, please edit the above-captured statement to attest to confidentiality and then insert that statement into the specification or drawings.
Applicant should please note that the remedial amendment to the specification (or drawings and specification) is/will not be considered New Matter at least because the breeding history is inherent to the plants/parts of tomato lines FIP-9S18-0174 or SVTG6217 and the originally filed specification contained both (i) a description of the morphological and physiological characteristics of a plant of lines FIP-9S18-0174 and SVTG6217 (Tables 1 and 2) and (ii) a reference to a deposit of representative “FIP-9S18-0174” or “SVTG6217” seed.
Please see the Objection to the Specification herein above that accompanies this Written Description rejection.
Furthermore, Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001).
Response to Applicant’s Remarks 21January2026:
(1) Applicant traverses this rejection because, according to Applicant, the deposit provides the necessary description (Remarks at pages 19-22, and at bridge of pages 23-24).
This is not persuasive for the reasons set forth in the rejection itself and, succinctly said, at least because per MPEP § 2163(I) a deposit is “not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description.” [emphasis added, citing In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985) and the Final Deposit Rules at 34,880].
(2) Applicant traverses this rejection because, according to Applicant, neither the MPEP nor 37 CFR § 1.809 require the specification to describe the breeding history/parentage (Remarks at the bridge of pages 22-23).
The Office disagrees for the reasons said of record and within the rejection copied herein.
(3) Applicant traverses this rejection because, according to Applicant, Plant Patent Practice, PVP Requirements, and UPOV Requirements are not legally relevant here (Remarks at pages 24-26).
The rejection of record and copied herein references other legal practices as evidence of what is generally understood in the art and to evidence that what is being asked for here is consistent with what is expected in other contexts (i.e., evidence that requiring breeding history/parentage information is common in the field and evidence that breeding history/parentage information is a well-recognized technical requirement by skilled artisans in plant genomics and/or performing plant breeding). To that end, the Office is not asserting that this rejection is made pursuant to Plant Patent, PVP, or UPOV rules/requirements (only that such rules/requirements also require information about a plant’s breeding history/parentage and, to that end, evidence that such information is needed to fully describe the plant). This argument is not persuasive. Please see the rejection of record and herein.
(4) Applicant traverses this rejection because other mechanisms are available to obtain information that may aid in search (Remarks at page 27 including Exhibits).
This is not persuasive because this rejection is not seeking more information for the sake of search (which Applicant notes in the Remarks has already been done). This rejection is being made because the specification lacks necessary information. To be clear, the parentage/breeding history information must be within the description or drawings of the specification (a response to a request for information would not be sufficient to overcome this Written Description rejection because that response would not place parentage/breeding history information within the specification at the description or drawings).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
1 Specification at pages 10-15.
2 See US Pat. No. 7612261 at Column 1, lines 60-65 regarding tomato plants/parts of hybrid variety “SX 387”, explaining that “a single-cross hybrid is produced when two inbred lines are crossed to produce the F1 progeny” and “the hybrid seed can be produced indefinitely, as long as the homogeneity and the homozygosity of the inbred parents is maintained”. See also LABROO et al. (“Heterosis and Hybrid Crop Breeding: A Multidisciplinary Review” 24February2021 Frontiers in Genetics 12:643761 doi:10.3389/fgene.2021.643761 (19 total pages)).
3 See WALTER “Backcross Method” Chapter 28 in Principles of Cultivar Development:Theory and Technique (1991, 17 total pages); available at https://dr.lib.iastate.edu/entities/publication/b12f8493-0f67-4dfb-b9bb-45e082b2268f. WALTER teaches that “[t]he term backcrossing refers to the repeated crossing of hybrid progeny back to one of the parents. The parent contributing the genes that control the desired character is called the nonrecurrent or donor parent. Nonrecurrent indicates that the parent is used only once in the backcross procedure and it does not recur. The parent to which the genes are transferred is called the recurrent parent. Recurrent indicates that the parent is used (recurs) repeatedly in the backcrossing procedure.” (page 360). WALTER further teaches that “[t]he objective of backcrossing is to recover the genes of the recurrent parent, except for the ones being transferred from the donor parent” (page 369) and that backcrossing is used “when the objective is to recover all of the features of the recurrent parent” (page 375).
4 See the specification at ¶40 on page 25.
5 Specification at pages 16-22.
6 See Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc., PGR2024-00023, Paper 15 (P.T.A.B. Oct. 15, 2024, 38 total pages) wherein the Board compared both the (a) morphological and physiological characteristics and (b) breeding histories for each of the patented variety and for the prior art variety to determine whether the patented claims were obvious;
See also Ex Parte C 27 USPQ2d 1492 (BPAI 1992, 11 total pages) where the Board agreed with Appellant as to Written Description (but the Examiner as to obviousness) and found that because the specification provided both (a) a description of “the characteristics of the seed and plant including flower color, plant type, maturity group, bacterial resistance, nematode resistance, etc.” and (b) “names the parent plants used to obtain the claimed cross”, there was enough information to identify the (claimed) plant variety “X” and distinguish it from other [varieties] [sic];
Compare US20230148529 (Appl. No. 18053336) and US Pat. No. 12010967 (Appl. No. 17455432) which are directed toward patentably indistinct siblings where the fact that the claimed varieties are siblings is only discernable by having (b) identical breeding histories in-hand because the sibling varieties have (a) disparate morphological and physiological characteristics) (i.e., it would not have been possible to identify the other variety based on just (a) morphological and physiological characteristics—breeding histories were needed);
See also MPEP § 1605 which say (albeit regarding Plant Patents) that:
“[t]The specification should include a complete detailed description of the plant and the characteristics thereof that distinguish the same over related known varieties, and its antecedents, expressed in botanical terms in the general form followed in standard botanical textbooks or publications dealing with the varieties of the kind of plant involved (evergreen tree, dahlia plant, rose plant, apple tree, etc.), rather than a mere broad nonbotanical characterization such as commonly found in nursery or seed catalogs. The specification should also include the origin or parentage and the genus and species designation of the plant variety sought to be patented.”;
and
See also the US Department of Agriculture’s requirements for Plant Variety Protection at parts 3 and 5 which require applicant’s to describe both the (b) “origin and breeding history” and the (a) “morphological, physiological, and other characteristics” of the variety (respectively) (“PVPO Program Requirements” United States Department of Agriculture (5 total pages), available at https://www.ams.usda.gov/services/plant-variety-protection/pvpo-requirements; last visited 28March2025).
7 See Tables 2 and 1, respectively, in the specification.
8 US20230240220 (soybean), now US Pat. No. 12317841.
9 US20160249543 (cotton).
10 US Pat. No. 9943057 (wheat).
11 US20230148508 (wheat), now US Pat. No. 12010967.