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 .
DETAILED ACTION
Election/Restriction
1. Applicant’s election with traverse of Group I, claims 1-20 in the papers filed January 16, 2026 is acknowledged.
Applicant primarily argues that claims of Groups I-III are unified because they are directed to soybean cultivar 3703870 (response, pages 1-2). Applicant’s arguments are carefully considered and are deemed to be unpersuasive. First, the restriction mailed in the papers of January 16, 2026 is under 35 U.S.C. 121 and not under 35 U.S.C. 372. Since it is not a 371 application (national stage application), 37 CFR 1.499 and PCT Rule 13.2 regarding unity of invention is not applicable here. Secondly, the inventions of II and III are patentably distinct from the invention of Group I for the reasons of record stated at pages 2-3 of the restriction/election mailed in the papers of January 16, 2026. However, in order to rejoin the claims of Group I and Group II, it is suggested to (i) amend the claim 21 of Group II by clearly reciting that food or feed product comprises at least one cell of soybean cultivar 3703870 and (ii) delete the recitation “oil” in claim 22.
Thus, claims 1-26 are pending. Claims 21-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly Claims 1-20 are examined on merits in the present examination. This restriction is made Final.
Applicant are reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Drawings
2. No drawings have been submitted in the instant application.
Information Disclosure Statement
3. Initialed and dated copies of Applicant’s IDS form 1449 filed in the paper of 06/26/2024 is attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
4. The disclosure is objected to because of the following informalities:
Page 62 of the specification: The deposit statement lacks NCMA Accession No. and the date deposit was made.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
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.
5. Claims 1-20 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1, 9 and 14 are rejected under 35 U.S.C. 112(b), as being indefinite in their recitation “NCMA No.____” because the “NCMA Accession No.” is missing.
Claims 1, 2, 7, 9, 13, 14, 17, 18 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite in their recitation soybean cultivar “3703870” because the recitation does not clearly identify the claimed soybean cultivar and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “3703870” is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of the soybean plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the NCMA deposit number.
Dependent claims are also rejected because they fail to overcome the deficiencies of parent claims.
Claim Rejections - 35 USC § 112(a), deposit
The following is a quotation 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.
6. Claims 1-20 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is noted that Applicant has indicated to deposit seeds of the claimed soybean variety 3703870. It is also noted that NCMA accession number and date of deposit is missing (see page 62 of the specification). Applicant needs to perfect the requirements of the seed deposit.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 (25 packets of 25 seeds each) seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Applicant has NOT indicated that Applicant intends to deposit the seeds at the ATCC in accordance with 37 CFR 1.801-1.809. Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the ATCC Accession No. and evidence of deposit to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
7. Claims 8, 10, 11, 15 and 19 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(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has recently clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id.
Finally, the court held:
A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP Section 2163, page 174 of Chapter 2100 of the August 2005 version, column 1, bottom paragraph, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Claims are broadly drawn to a soybean plant produced by the methods of claim 7, 9 or 14 and wherein the plant comprises any desired trait, or a soybean plant produced by the method of claim 18.
The breadth of claims encompasses multiple trait(s) introduced due to incorporation of unlimited number new genes, mutating any number of existing genes and editing any number of existing gene(s) to obtain the function of any number of desired characteristics to the soybean plant as claimed.
The breadth of claim encompasses a very large genus comprising unknown changes/mutations (structures) having unknown or undescribed function.
Applicant’s broadly claimed genus encompasses a genus with unknown species whose structure and function relationship is unknown and not described.
The instant specification, however, only describes soybean variety “3703870” having physiological and morphological characteristics as described in Table 1.
Applicant fails to describe structure of representative species of Applicant’s broadly claimed genus and thus their function is either unknown or unpredictable.
There is no description of the structure required for the recited function, and no description of the necessary and sufficient elements of functional activity of diverse species involved in obtaining the desired functional phenotype. Applicant’s broadly claimed genus encompasses structures whose function is unknown.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, species soybean variety “3703870” is insufficient to describe the claimed genus.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing.
Claim Rejections - 35 USC § 112 (Written Description-Lack of Breeding history)
8. Claims 1-20 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.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new soybean cultivar 3703870. So, the examiner will evaluate what is an adequate written description for a new soybean variety. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant cultivar has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in Table 1. However, there is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)).
The International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)).
Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (See Ex Parte C (USPQ 2d 1492 (1992) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). In both of these cases, there were many differences cited by the Applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP 2163 (I) states “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. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. 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.").”
MPEP 2163(I) states “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." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a cultivar.
Moreover, a specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. This disclosure does not address all the issues set forth above. Thus, the breeding history for the claimed cultivar as disclosed in the Specification is missing. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed cultivar. It may be noted that there is natural variation in soybean caused by genetics and environment. Additionally, paragraph [0049] at page 7 states the soybean plant includes any single gene conversions of that cultivar, and said plant has essentially all the morphological and physiological characteristics of the cultivar. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of soybean plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed cultivar, including all names for the parents and for the claimed cultivar, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
9. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eby (U.S. Patent No. US 9,060,487 B1, Published June 23, 2015).
The claims are broadly drawn to seeds and plants of soybean cultivar 3703870, parts and tissue cultures thereof, methods of breeding thereof, and methods of using said plant or plant parts to produce plant products.
Eby teaches soybean cultivar 33193068 having black hilum, purple flower, light tawny pubescence, dull seed coat luster (mature seed), cyst nematode resistance, and indeterminate growth habit. These traits are shared with soybean cultivar 3703870 of the instant invention. Eby also teaches transforming said soybean cultivar 33193068 with a transgene by transformation and by backcrossing from another transgenic soybean plant. The reference also teaches an F1 hybrid produced from such crosses and a method of making said F1 hybrid. Yates also teaches methods of using soybean cultivar 33193068 in producing commodity plant products. Eby also teaches that soybean cultivar 33193068 as having a relative maturity of 3.8 which is identical to the relative maturity of soybean variety of the instant invention, which has a relative maturity of 3.8. The reference also teaches introducing new traits through mutations. See in particular, abstract, columns 1-36; claims 1-20; table 1.
The instant claims are prima face obvious over the teachings Eby because soybean cultivar 33193068 taught by Eby and soybean cultivar 3703870 of the instant application appear to be obvious variations without evidence to contrary. It would have been obvious to introduce new traits using variety of techniques but not limited to gene mutation, gene editing (CRISPR/Cas gRNA system, for example) that were widely and readily know prior to the earliest filing date of the instantly claimed invention. Although the method of making soybean cultivar 3703870 taught by Eby and soybean cultivar 3703870 of the instant application may differ, the products made appear to be obvious variations of one another.
Conclusion
10. Claims 1-20 are rejected
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. Abraham can be reached on (571) 270-7058 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VINOD KUMAR/Primary Examiner, Art Unit 1663
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