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 22May2025 are acknowledged and have been fully considered. Claims 1-13 are pending, original, and 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 63119470 filed 30November2020] and 35 U.S.C. 121 [divisional of 17536731 filed 29November2021, now US Pat. No. 12336482]. Claims 1-13 have an effective filing date of 30November2020.
Deposit
For the sake of a clear record, a Deposit Rejection would have been made but-for the information provided at ¶¶ 327-329 on pages 99-100 of the specification. Please note that “Applicant has/will comply with all of the requirements set forth in 37 C.F.R. § 1.801-1.809.” (¶329 on page 100 of the specification).
Specification
The disclosure is objected to because of the following informalities: further to the Written Description rejection herein below, the specification is objected to because it does not sufficiently describe the breeding history of variety 20506064. Appropriate correction is required.
The disclosure is objected to because of the following informalities: the deposit date information is missing at ¶328 on page 100 and, if the objection below is correct, a reference to the ATCC accession number “X22” needs correction. Appropriate correction is required.
Claim Objections
Claims 1, 9, and 13 are objected to because of the following informalities: these claims (and the specification, as noted within the objection above) refer to an ATCC Accession Number “X22”. The “X22” designation appears to be incorrect (it is not in compliance with the ATCC’s accession number format for patent deposits). Please ensure “X22” is correct and either correct the recitation or clarify the record.
Claim 9 is objected to because of the following informalities: for technical correctness, please amend the claim to refer to “when grown in the same environmental conditions” such as via “… wherein the plant, when grown in the same environmental conditions, has all of the morphological and physiological characteristics of ….” (¶185 on page 54 of the specification). Appropriate correction is required.
Claim 13 is objected to because of the following informalities: for technical correctness, please amend the claim to say that plants/parts of variety 20506064 are made such as something like the following: “A method of making plants or plant parts of soybean variety [[designated as]] 20506064, said method comprising ….” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-13 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.
These claims are directed toward plants/plant parts of soybean variety “20506064” and wherein a representative sample of 20506064 seed will be (or has been) deposited with ATCC. Since seed of 20506064 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 20506064 seed and (2) the 20506064 seed does not appear to be otherwise publicly available; the Office believes that (3) a deposit in compliance with 37 CFR 1.801-1.809 of 20506064 seed is needed for this application (37 CFR 1.809(a)). To that end, please see the “but-for” Deposit paragraph hereinabove wherein the Office acknowledges the Applicant’s assurance that a deposit of 20506064 seed will be done and perfected (consistent with US rules and laws) in due course.
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 variety 20506064 (Table 22 of the specification at page 54), but the current specification does not describe (b) the breeding history (parentage) of 20506064.
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 1-13 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 the 20506064 variety. 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” (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). 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 variety 20506064 and the originally filed specification contained both (i) a description of the morphological and physiological characteristics of a plant of variety 20506064 (Table 22 on page 54 of the specification) and (ii) a reference to a deposit of representative “20506064” 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
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 each other);
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.
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