ONION HYBRID SVNT1608

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 14September2026 are acknowledged and have been fully considered. Claim 4 is cancelled. Claims 1-3, 5-28 are pending and examined on the merits herein. Claims 2-3, 5-18, 21-28 are currently amended. Claims 1, 19-20 are original. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 63605980 filed 04December2023] is acknowledged. Claims 1-3, 5-28 maintain an effective filing date of 04December2023. Claim Interpretation As amended 14September2026, claim 21 is a method claim encompassing an unlimited number of backcrosses or outcrosses, but the product claims 22-26 recite “first generation progeny” and are, therefore, interpreted (with respect to outcrosses) as being limited to the F1 generation outcross from a plant/part of onion hybrid SVNT1608 (i.e., are the product of no more than one outcross from a plant/part of onion hybrid SVNT1608). Applicant has used its own language, but the “first generation progeny” phrase is considered commensurate with what was suggested by the Office within the Written Description rejection at ¶18 on pages pages 9-11 of the nonfinal action 28April2026. Therefore, the Written Description rejection at ¶18 on pages pages 9-11 of the nonfinal action 28April2026 is withdrawn and no new Written Description rejection of claims 22-26 is being made herein. [Copied from the Nonfinal 28April2026 →] The following claim interpretation(s) are being made of record: Where it is said that a plant/part is “of onion hybrid SVNT1608” (see claims 1, 10, 12) or comprises “all of the physiological and morphological characteristics of” a plant of onion hybrid [variety/cultivar] SVNT1608 when grown under the same environmental conditions (see claim 4), this is interpreted to mean that the plant comprises all of the traits listed in Table 1 (¶34 on pages 10-13 of the specification) determined at a 5% significance level for numerical (quantitative) characteristics and determined by type or degree for non-numerical (qualitative) characteristics. This interpretation is believed to be, and is intended to be, consistent with the specification (for example at ¶46 on page 16). This interpretation by the Office is material to the objections or rejections herein (see the obviousness, Written Description, and Scope of Enablement rejections below) If Applicant disagrees with this interpretation, an appropriate response should be made of record to that effect. No substantive reply will be taken as a confirmation by Applicant that the Office’s interpretation(s) are correct. Applicant is reminded that “the doctrine of prosecution disclaimer ensures that claims are not construed one way [by Applicant] in order to obtain their allowance and in a different way against accused infringers” (SandBox Logistics LLC v. Proppant Express Invs. LLC, 813 F. App'x 548, at 556 (Fed. Cir. 2020)) and, to that end, “[Applicant' s] failure to challenge the Examiner' s understanding amounts to a disclaimer” (SandBox v. Proppant infra at 554; citing Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d 1090, at 1096 (Fed. Cir. 2013)). Furthermore, Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Withdrawn Objections and/or Rejections Objections and/or rejections made of record in the nonfinal office action dated 28April2026 that are not otherwise discussed herein are withdrawn. In particular: RE ¶¶ 6-12: The objections are withdrawn in view of the amendments to the claims (all of which are commensurate with what was requested by the Office). RE ¶¶ 13-14: The indefiniteness rejections are withdrawn in view of the amendments to the claims. RE ¶ 15: The Written Description rejection of claims 2 and 23 is withdrawn in view of the amendments to the claims (claim 2 being amended as suggested by the Office and claim 23 being amended in other material ways). RE ¶ 16: The Written Description rejection of claim 4 is withdrawn in view of claim 4 being cancelled. RE ¶ 17: The Written Description rejection of claim 9 is withdrawn in view of the amendments thereto (which are commensurate with what was suggested by the Office). RE ¶ 18: The Written Description rejection of claims 21-26 is withdrawn in view of the amendments thereto, including the phrase “first generation progeny”. As said within the Claim Interpretation section above, claim 21 is a method claim encompassing an unlimited number of backcrosses or outcrosses, but the product claims 22-26 now recite “first generation progeny” and are, therefore, interpreted (with respect to outcrosses) as being limited to the F1 generation outcross from a plant/part of onion hybrid SVNT1608 (i.e., are the product of no more than one outcross from a plant/part of onion hybrid SVNT1608). Applicant has used its own language, but the “first generation progeny” phrase is considered commensurate with what was suggested by the Office within the Written Description rejection at ¶18 on pages pages 9-11 of the nonfinal action 28April2026. Therefore, the Written Description rejection at ¶18 on pages pages 9-11 of the nonfinal action 28April2026 is withdrawn and no new Written Description rejection of claims 22-26 is being made herein. RE ¶¶ 20-21: The anticipation and obviousness rejections over “Rupp Seeds” is withdrawn because, according to Applicant, the “Rupp Seeds” webpage (or other sale or offer for sale) was not available (or did not occur) until after the effective filing date of this application (see Parts G and H of the Remarks 14September2026 and the KELLY declaration (2 pages) filed 14September2026). See MPEP § 2133.03(b). RE ¶ 23: The Deposit Rejection regarding onion hybrid SVNT1608 seed is withdrawn in view of the following statement by the representative of record (Remarks 14September2026 at pages 32-33): PNG media_image1.png 203 528 media_image1.png Greyscale . Specification The disclosure REMAINS objected to because of the following informalities: further to the corresponding Written Description rejection herein below, the specification is objected to because it does not sufficiently describe the parentage/breeding history of onion hybrid [variety/cultivar] SVNT1608. Appropriate correction is required. Response to Applicant’s Remarks 14September2026: Applicant traverses this objection based on the Remarks provided with respect to the Breeding History Written Description rejection below. That traversal is not persuasive for the reasons provided below. 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. II.) No Parentage/ Breeding History in the Specification: Claims 1-3, 5-28 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. ↓ Rejection Copied From Nonfinal, Please See Response to Applicant’s Remarks For New Content ↓ These claims are directed toward plants/plant parts of a hybrid onion variety which Applicant refers to as “SVNT1608” and wherein a representative sample of SVNT1608 seed has been, or will be, deposited with NCMA. Since seed of SVNT1608 is essential to the claimed subject matter, such seed 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 SVNT1608 seed and (2) the SVNT1608 seed may not be otherwise publicly available (see prior art rejections herein); the Office believes that (3) a deposit in compliance with 37 CFR 1.801-1.809 of SVNT1608 seed is needed for this application (37 CFR 1.809(a)). To that end, please see the Deposit Rejection herein. 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 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.1 The technical/scientific basis for needing both (a) and (b) is intracultivar heterogeneity and environmental variation. Intracultivar heterogeneity is the fact that even plants all belonging to an elite cultivar/line do not have homogenous genetic pools (amongst themselves): such plants will maintain some degree of plant-to-plant variation because of, for example, segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations.2 Environmental variation is the fact that (as is reflected throughout this specification) even slight changes in the environmental conditions under which a plant/part is grown may cause phenotypic changes in that plant/part.3 Because of intracultivar heterogeneity and environmental variation, only having (a) the morphological and physiological characteristics (“traits”) of a variety/line is not enough "to aid in the resolution of questions of infringement." [MPEP §2163(I) citing Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,880 (August 22, 1989)] or for "the examiner [to] be able to compare the identity and characteristics of the deposited biological material with the prior art.” [MPEP §2163(I) citing the Final Deposit Rules at 34,880]—a description of (b) the breeding history (parentage) is also needed. The current specification describes (a) the morphological and physiological characteristics of a plant/part of hybrid onion variety SVNT1608 (Table 1 of the specification), but the current specification does not describe (b) the breeding history (parentage) of SVNT1608. To be clear, the only description of parentage/breeding history provided by the specification is the following (from ¶33 on page 10 of the specification): PNG media_image2.png 220 728 media_image2.png Greyscale One will note that material information is not given (such as identifying details about either parent plant, e.g. a name/identification number). Based on the current record, the Office believes that the current specification does not meet the guidance set forth in MPEP §§ 2163(I), (II) and, therefore, 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 1-28 require the deposited seed, and because the current specification does not evidence compliance with 37 CFR § 1.809(d)(3), 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 (parentage) used to develop hybrid onion variety SVNT1608. As noted herein above, the current breeding history information at page 10 of the specification is deficient as to as least identifying details about either parent plant (e.g. a name/identification number) Please note that the breeding history 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/line. Some acceptable breeding history disclosures may be found at, for example: the specification for Appl. No. 175870364 at ¶196 on page 60 of the specification; the specification for Appl. No. 149960935 at line 15 on page 5 to line 4 on page 7 of the specification; the specification for Appl. No. 152660526 at line 13 on page 10 to line 20 on page 11 of the specification; and the specification for Appl. No. 174554327 at ¶¶121-124 on page 45 of the specification. Specifically for claims directed toward a hybrid plant variety, the specification for Appl. No. 17808804 (now US Pat. No. 12295321) is exemplary (see ¶127 on page 17 wherein it is simply said that the claimed hybrid X18V358 variety “can be made by crossing inbreds PH4CDT and 1PFVL58” and then Applicant deposited a sample of both inbred parents). 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” (the latter of which denotes ownership)—in these scenarios, it is material that the specification describes unpublished parent plants as just that (describe them as 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). Candidly, the Office highly recommends giving all plants (even unpublished plants) a name/identifier so that there is no question about whether two+ plants/parts have the same genomic composition (because it would be clear that they have disparate breeding histories) and, in that way, lessen the likelihood that infringement, anticipation, or Double Patenting questions arise, for example. Applicant should please note that the remedial amendment to the specification (or drawings and specification) is/will not be considered New Matter because this scenario is analogous to that set forth in 37 C.F.R. § 1.804 (see MPEP § 2406) discussing deposit practice (including deposits made after the effective filing date of an application for patent and before the payment of the issue fee). This is analogous at least because the breeding history is inherent to the plants/parts of hybrid corn variety SVNT1608 and the originally filed specification contained both (i) a description of the morphological and physiological characteristics of a plant of hybrid corn variety SVNT1608 (Table 1 of the specification) and (ii) a reference to a deposit of representative “SVNT1608” seed. Please see the Objection to the Specification herein above that accompanies this Written Description rejection. Please note that submitting parentage/breeding history information confidentially into the record (e.g., via an artifact folder) is not sufficient to overcome this rejection or otherwise meet the Written Description requirement at issue here because 35 USC § 112(a) explicitly states that “the specification shall contain a written description of the invention” (emphasis added) which, in view of MPEP § 600, means that the description and/or drawings must contain the parentage/breeding history information. 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 14September2026 and the HENDRICKS Declaration 14September2026: As an initial matter, this rejection is based on the requirement that merely depositing a biological sample (here, seed) is not enough to satisfy the Biological Deposit Rules set forth under 37 CFR 1.801-1.809. The Deposit Rules also require “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”. In general terms, 35 U.S.C. 112 provides utility, written description (possession and new matter), as well as enablement patentability requirements. This is important context because while the Office has pointed towards case law regarding possession (a lack of written description due to a lack of evidence showing possession), those cases are only relevant in so far as they explain what is sufficient to meet the Deposit Rules’ requirement for “a description of the deposited material”. This rejection is not based on whether or not the as-filed specification evidences possession of a plant/part of onion hybrid SVNT1608. The issue here may be summarized as follows: What information is needed to meet the Deposit Rules’ requirement for a “description of the deposited material sufficient to specifically identify it” (37 CFR § 1.809(d)(3))? The Office maintains that, based on the art, both breeding history information and a trait table are needed; whereas Applicant maintains that only a trait table is needed. To be clear, there is no question that the “description” has to be in the specification because 37 CFR § 1.809(d)(3) explicitly states “specification”. To that end, Applicant’s Remarks regarding 37 CFR §1.105 are addressed below, but providing the requisite “description” outside of the specification (such as by information provided to the Office pursuant to 37 CFR §1.105), whether or not such description includes breeding history information, is irrelevant to the this outstanding rejection because the rejection is based on the Deposit Rules and the current Deposit Rules explicitly require the description to be within the specification). Further to the paragraph immediately above, Applicant argues that the deposit of seed representing SVNT1608 and as-filed specification “reasonably conveys to a person of ordinary skill in the art that the inventors were in possession of the claimed subject matter as of the filing date” (¶5 on page 10). This argument is repeated elsewhere in the Remarks (last paragraph on page 12, e.g. at citation to Enzo Biochem., Inc. v. Gen-Probe, Inc., through the second paragraph on page 13, citing Ariad Pharms., Inc. v. Eli Lilly & Co.). See also pages 27-28. This is not persuasive because it is an argument about possession, which is not relevant here. Applicant argues that “no statute, rule, or precedent requires a breeding history in the specification” (see pages 13-18 and the bridge of pages 20-21). Regarding certain cited references, Applicant states the following from page 19 and the bridge of pages 23-24: PNG media_image3.png 220 532 media_image3.png Greyscale PNG media_image4.png 202 522 media_image4.png Greyscale The Office agrees that there is no known statute, rule, or precedent currently in effect which explicitly requires the specification to publicly disclose parentage/breeding history information in this context (a patent application regarding plants/parts of a particular cultivar/line and for which representative seed has, or will be, deposited in compliance with the Budapest Treaty). The outstanding question here is whether or not such parentage/breeding history information is needed (in addition to a perfected deposit and a list of defining morphological and physiological characteristics/traits) to meet the requirement for “a description of the deposited material sufficient to specifically identify it and to permit examination” (37 CFR § 1.809(d)(3)). Based on the information provided by MPEP § 2163(I) and knowledge within the art (see the references in footnote #1 of the rejection), parentage/breeding history information is believed to be needed. To that end, Applicant’s Remarks are not persuasive. For clarification, footnote #1 refers to, for example, an Inari Post-Grant Review (PGR) decision, Ex Parte C, USPTO Plant Patent guidance, and USDA Plant Variety Protection guidance. Further to the sentence at the start of this paragraph, the Office acknowledges and agrees with Applicant’s comment that rules regarding Plant Patents or Plant Variety Protection certificates are not binding here—if they were, parentage/breeding history information would be explicitly required (per USDA Plant Variety Protection guidance). The Office has referred to those documents because they evidence what is known and understood in the art, i.e., they show that a skilled artisan would need 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 to distinguish a plant of one variety from a plant of a second variety and to, therefore, “specifically identify” the deposited material in compliance with 37 CFR § 1.809(d)(3)). Regarding the specification providing parentage information (as opposed to the record, such as by a confidential disclosure of information pursuant to 37 CFR § 1.105), the Deposit Rules currently say that the specification must provide the “description of the deposited material sufficient to specifically identify it” (See 37 CFR § 1.809(d)(3))—this means that while Applicant and the Office may disagree as to what information is needed to meet the “description … to specifically identify it” requirement (i.e., the Office believes, based on the art, that breeding history information and trait table are needed while Applicant believes only a trait table is needed), there is no doubt that such description has to be in the specification because the current Deposit Rules explicit require it. Applicant’s Remarks (pages 20-21) and the HENDRICKS Declaration (¶¶6-9) assert that, especially because the parent varieties in this instance are confidential, proprietary varieties with identifiers that are meaningless to anyone other than Applicant, providing such identifiers in the specification would “provide no description beyond the deposit information and the phenotypic characteristics already provided in the specification that a person of ordinary skill in the art would use to identify the claimed plants or to determine whether a given plant is a plant of onion hybrid SVNT1608.” (¶9 of the HENDRICKS Declaration, see also ¶6 of the HENDRICKS Declaration which is copied and discussed at page 20 of the Remarks). This is not persuasive because parent identifiers, so long as they are used consistently, may “specifically identify” a deposited material by distinguishing it from other deposited material (as is/was the case with distinguishing the plants/parts of US Pat. No. 12414519 from plants/parts of US Pat. No. 12010967, cited and discussed in the rejection at footnote #1). As an aside, the Office is relieved for Applicant to confirm that there is a low barrier to Applicant in providing the names/identifiers of parent lines within the specification or drawings because Applicant does not believe such information to be probative of plant identity. In the context of discussing intracultivar heterogeneity and environmental variation (see discussions of HAUN et al. and GROBKINSKY et al.), the Remarks (pages 20-22) and the HENDRICKS Declaration (¶¶7-8) suggest that the deposit would be sufficient for a skilled artisan to determine whether any given onion plant is of the SVNT1608 variety because such person “would compare the genotype of the plant to the genotype of the deposited hybrid using genetic marker analysis.” (HENDRICKS Declaration at ¶8). This is not persuasive for several reasons. First, Applicant is reminded of pending claims 18 and 19: PNG media_image5.png 126 534 media_image5.png Greyscale Is Applicant suggesting that claims 18-19 should be practiced (infringed?) in order to “specifically identify” the deposited material? Second, the suggestion to use “genetic marker analysis” is obscuring the fact that genetic markers must first be identified which, when present, specifically identify a plant/part of SVNT1608 (e.g., a sequence signature that is tightly linked to a gene underlying a particular phenotype of SVNT1608 plants or a sequence signature (such as a SNP profile) that, when present, indicates that the plant/part is of the SVNT1608 cultivar/line). As is described at ¶72 on pages 24-25 of the specification, useful genetic markers are those which “are able to identify or select for certain traits or polymorphisms of onion hybrid SVNT1608 or progeny thereof.” Because of intracultivar heterogeneity, for example, a skilled artisan cannot simply sequence the deposited SVNT1608 onion plant’s genome and compare it to another onion plant’s sequenced genome and reasonably expect to determine whether the plants are related (this is especially true in the context of onion plants which have large, repeat-heavy genomes (see FU et al. “Identification and characterization of abundant repetitive sequences in Allium cepa” 2019 Scientific Reports 9: 16756 (7 total pages)). If Applicant has already identified genetic markers which, when present, “specifically identify” a plant/part of SVNT1608; the Office would consider a disclosure of such genetic markers (in lieu of parentage/breeding history) as a means to “specifically identify” the deposited material in compliance with 37 CFR 1.801. Importantly, the Office has focused on parentage/breeding history information as a low-barrier and art-accepted means for meeting the “specifically identify” requirement of 37 CFR 1.801-1.809, but if Applicant has other ideas for how such plants may be “specifically identified” (such as by describing a genetic marker profile specific for SVNT1608 plants); Applicant should please contact the Office to discuss such ideas. Applicant’s discussion of Ex Parte C appears to suggest that the parentage/breeding history information is to facilitate examination (the Examiner’s search of the art, in particular). See the Remarks at pages 20-22 and 24-26. As said above, this rejection is based on the requirement of 37 CFR 1.809(d)(3) that the specification must provide a description of the deposited material sufficient to specifically identify it. As is acknowledged by the Remarks (at the top of page 26), the Examiner is already in possession of confidentially-filed information sufficient for examination to occur (including a search of the art, which was completed in advance of the nonfinal action 28April2026 being mailed). To that end, providing parentage/breeding history is not requested to facilitate examination, but rather to satisfy the description requirement of 37 CFR 1.801. Also, all should please keep in mind that the relevance of Ex Parte C to this scenario is nuanced at least because the parent plants in the Ex Parte C case were specifically identified and known and, as Applicant pointed out, much of Ex Parte C regards obviousness (not description). Both the Office and Applicant have referred to Ex Parte C, but the record needs to be clear that it is not a 1:1 comparison of the facts and rejection of this application to the facts and rejections of Ex Parte C. As a specific example, the following discussion of Ex Parte C (from the Remarks at the top of page 27) fails to clarify that the parent plants in Ex Parte C were specifically identified and known—if the facts of this case were analogous to those of Ex Parte C (the parent plants being named and known), then, of course, the description requirement of 37 CFR § 1.801 would already be satisfied here and both the Office/Examiner and the Ex Parte C Board would agree with Applicant that “the Office may not require that ‘additional information regarding the inventive process’ be included in the specification when § 112 is otherwise satisfied” (Remarks at the top of page 27, also copied below). The facts here are materially different from those of Ex Parte C, so all should please be careful when making conclusory comments based on Ex Parte C. PNG media_image6.png 143 527 media_image6.png Greyscale Related to the above, Applicant asserts that this rejection is based upon an effort to facilitate examination and that “if every item of information needed to examine a claim had to appear in the specification to satisfy § 112(a), [then] § 1.105 would be superfluous” (Remarks at page 25, citing the last sentence thereon). First, this rejection is based on the requirement of 37 CFR 1.809(d)(3) that the specification must provide a description of the deposited material sufficient to specifically identify it (this rejection is not being made to facilitate examination and, in fact, providing parent identification information would be redundant to the information already in the Examiner’s possession). Second, the requirement at issue here (Deposit Rule set forth in 37 CFR § 1.809(d)(3)) is that the specification has to provide “a description of the deposited material sufficient to specifically identify it”. Providing parentage/breeding history in the specification to satisfy 37 CFR 1.809(d)(3) would not make 37 CFR § 1.105 superfluous at least because 37 CFR § 1.105 is relevant outside of the context of biological deposits and is not tethered to the specification (as Applicant knows well, information requested and disclosed to the Office under 37 CFR § 1.105 need not be made publicly available, and information supplied to the Office in response to a request under 37 CFR § 1.105 is often filed under seal so that it is maintained confidentially by the Office and later expunged in late examination/prosecution—such information is never part of the public record and definitely not part of the published specification that accompanies a published patent application or issued patent). Applicant provides exemplary US patents which, according to Applicant, do not describe parentage/breeding history (Remarks at pages 22-23 and Exhibit C). These references are acknowledged, but are not persuasive for overcoming this rejection at least because the examination/prosecution of one application does not dictate the examination/prosecution of another application. As an aside, Applicant should be careful when referring to “cultivar case” practices by the Office because, as Applicant knows well, there are many hundreds (thousands?) of cultivar applications that have passed through the Office (spanning many different plant types over the decades)—the historical practice has been for Applicants to specifically identify at least one parent line of the claimed cultivar/line (even when the parents are proprietary and confidential) and to provide at least a cursory overview of the breeding methods used to arrive at the claimed cultivar/line (e.g., a confirmation that a claimed inbred cultivar/line is from the 5+ generation so as to evidence it having stable genetics and not being a wild plant/naturally occurring subject matter). So, historically, the Office has not had to ask for breeding history information when examining “cultivar cases” because such information was already provided by Applicant. To that end, in the event the examination/prosecution of other applications is considered probative here; this application appears to diverge from historical practice. Regarding the specification providing parentage information (as opposed to the record, such as by a confidential disclosure of information pursuant to 37 CFR § 1.105), the Deposit Rules currently say that the specification must provide “a description of the deposited material sufficient to specifically identify it” (See 37 CFR § 1.809(d)(3)). 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. Claim 2 REMAINS rejected and claims 8-9 ARE rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being 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 onion variety SVNT1608 as well as returning to “all the physiological and morphological characteristics of” a plant/part of hybrid onion variety SVNT1608 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. This rejection is based on the fact that Applicant has only deposited hybrid 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. As amended 14September2026, claims 4, 10-13, and 23 are no longer rejected here (claim 4 is cancelled, claims 10-13 now specify introduction by transformation or site-specific modification such as CRISPR/Cas gene editing, and claim 23 is no longer commensurate with claim 2). As amended 14September2026, claim 9 is now added to this rejection. In particular, while a skilled artisan may grow a plant of hybrid onion variety SVNT1608 by planting the deposited hybrid seed (hence, claim 1 is not rejected here), that artisan cannot make/reproduce seed of hybrid onion variety SVNT1608 because hybrid seed do not breed true to type (meaning that seed generated from hybrid onion variety SVNT1608 will produce plants with materially different structure and function/phenotype than what is described of hybrid onion variety SVNT1608 at Table 1 (which is why claim 2 is rejected here)—a skilled artisan needs to cross the inbred parents to regenerate F1 hybrid seed8). A skilled artisan first needs access to the seed of each inbred parent variety before such person can make a hybrid seed (in this case, make a seed of hybrid corn variety SVNT1608). Claim 2 is rejected here because it recites seed. Claims 8-9 are now rejected here because, as amended, they make/refer to a plant into which a transgene has been introduced and that otherwise comprises “all of the physiological and morphological characteristics of” a plant of hybrid variety SVNT1608. Materially, transgenes may be introduced using crosses/breeding methods (as was pointed out regarding claims 10-11 in the nonfinal 28April2026). Therefore, to the extent claims 8-9 encompasses introducing a transgene via an outcross and then returning to a plant/part that has “all of the physiological and morphological characteristics of” a plant of hybrid variety SVNT1608 (which means the plant has the physiological and morphological characteristics listed in Table 1, with a reasonable degree of variation around quantitative traits), access to the inbred parent plants (to perform backcrosses) is believed to be required. To ensure clarity, the following was said at lines 12-15 on page 21 of the nonfinal 28April2026: “[W]hile claims 8-9 refer to introducing a transgene into a plant/part, please note that those claims do not refer to the resulting plant/part being “of onion hybrid [variety] SVNT1608” (meaning there is not an explicit requirement that the modified plant/part return to the characteristics in Table 1). Therefore, claims 8-9 are not rejected here.” The amendments 14September2026 bring claims 8-9 into this rejection. Because the inbred parent varieties at issue here do not appear to be publicly available and representative seed for each of the inbred parent varieties are not (or will not), based on the current record, be made available by Applicant (e.g., via Deposit practice); 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) deposited representative samples of seed of both of the inbred parent varieties (in compliance with the Deposit rules including accompanying amendments to the specification and claims) or (2) amended the claims to exclude subject matter that is not enabled. Response to Applicant’s Remarks: Applicant asserts that the claim amendments are sufficient to overcome this rejection (Remarks 14September2026 at pages 31-32). This is true in some respects and not others—please see the claim-by-claim explanation within the rejection above. 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. 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. 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 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. /REBECCA STEPHENS/Examiner, Art Unit 1663 /MATTHEW R KEOGH/Primary Examiner, Art Unit 1663 1 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 US Pat. No. 12414519 (Appl. No. 18053336) and US Pat. No. 12010967 (Appl. No. 17455432) which are directed toward patentably indistinct siblings—a fact only discernable by having (b) identical breeding histories in-hand because the siblings have (a) disparate morphological and physiological characteristics) (i.e., a description of just (a) each variety’s morphological and physiological characteristics is/was not enough information to know that the two varieties are siblings and, thus, obvious variations of eachother); 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). 2 See HAUN et al. “The composition and origins of genomic variation among individuals of the soybean reference cultivar Williams 82” 2011 Plant Physiology 155:645-655 at the bridge of pages 645-646. 3 See GROBKINSKY et al. “Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap” 2015 Journal of Experimental Botany 66(18):5429-5440 at page 5430 and figure 2 on page 5431. 4 US20230240220 (soybean), now US Pat. No. 12317841. 5 US20160249543 (cotton). 6 US Pat. No. 9943057 (wheat). 7 US20230148508 (wheat), now US Pat. No. 12010967. 8 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)).