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 .
Election/Restrictions
Applicant’s election without traverse of the Species drawn to soybean variety EE2001788 in the reply filed on February 20, 2026, is acknowledged.
This Restriction/Election Requirement is made FINAL.
Claims 1-20 are pending and examined on their merit herein.
Specification
The disclosure is objected to because of the following informalities:
The Specification is also rejected for the recitation of plant morphological traits in Tables 1, 3, etc, such as
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in Table 3. The first letter P is interpreted as referring to purple flower color. The second and third letter LT is interpreted as light tawny pubescence color. The last two letters “Iy” is interpreted as “imperfect yellow” for the fourth trait, hilum color. However, under this interpretation, it appears the pod wall color descriptor is missing. Applicant is strongly urged to ensure that the traits “flower, pubescence, pod color, and hilum” are completely represented in the 5-letter codes used throughout the Tables.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: claim cites a deposit number. It is suggested to cite the complete form including (at least the abbreviated) name of the deposit agency, i.e., NCMA. Appropriate correction is required.
Improper Markush Grouping
Claim 1-20 are rejected on the basis that the claims contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1 and 18 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
In the instant case, claim 1 or 18 recite 3 different soybean lines/varieties/cultivars. There is no evidence that the 9 different soybean lines recited in the instant claims are closely genetically related, given the lack of any disclosure of the parental lineage and breeding history. Furthermore, the 9 different soybean lines as disclosed differ in morphological traits due at least to differences in flower color, pubescence color, pod color, and/or hilum color (Tables 1, 3, 5), it is clear that they do not share a specific function (trait) conferred by a specific structure (genetic background).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-20 are rejected for the recitation of “soybean variety EE2001788”.
The claims are directed to plants and seed of soybean EE2001788and methods of using them.
MPEP instructs that a “decision on whether a claim is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph requires a determination of whether those skilled in the art would understand what is claimed when the claim is read in light of the specification.” (MPEP 2173.02 Determining Whether Claim Language is Definite; emphasis added) Furthermore, MPEP instructs that a “claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty” (MPEP 2173.03).
In the specification, Applicant refers to “soybean variety EE2001788” (throughout the Specification, e.g., p. 6) and “soybean line EE2001788” (e.g., p. 8) and “soybean cultivar EE2001788” (e.g., p. 20). The specification also refers to EE2001788 with no designation of being a variety, a line, or a cultivar, e.g., as “soybean CL2041756” (e.g., p. 45).
Applicant defines the term “variety” as follows:
“Variety” or “Cultivar” refer to a substantially homozygous soybean line and minor modifications thereof that retains the overall genetics of the soybean line including but not limited to a subline, a locus conversion, a mutation, a transgenic, or a somaclonal variant. Variety or cultivar include seeds, plants, plant parts, and/or seed parts of the instant soybean line. (Spec., p.19). [Emphasis added].
This definition makes it clear that a soybean “line” is of a narrower scope, and a soybean “variety” or “cultivar” is broader which includes modifications relative to the “line”. However, it is unclear if the various instances of “soybean variety EE2001788”, “soybean line EE2001788”, “soybean cultivar EE2001788”, or “soybean EE2001788” are interchangeable, referring to the exact material deposited under NCMA Accession Number 202302017, or different plants having different genetic makeup, physiological and morphological characteristics.
Furthermore, with regard to the definition of variety and cultivar, it is unclear what is meant by “substantially homozygous soybean line”. It is unclear what is meant by “minor modifications”. It is unclear what is meant by “retains the overall genetics”. It is unclear what a “subline” is. A locus conversion, a mutation, a transgenic, and a somaclonal variant are all derivatives produced by modifying a starting material, and it is unclear what starting material is being referred to in this context.
Claim 1 recites “representative seed” of soybean EE2001788 having “been deposited under NCMA Accession Number 202302017”, and it is unclear how the seed is “representative”. Since the “variety” or “cultivar” are defined to encompass any number or types of genetic and phenotypic changes, it is unclear in what way the deposited seeds are “representative” of the variety or the cultivar because it is unclear what is required to remain constant and unchanged. Furthermore, it is unclear if the plants utilized to collect the physiological and morphological data in the Specification as the written description, were of the same genetic makeup as those deposited with the NCMA. It is unclear whether there has been any modifications made between the deposited seeds and the experiments performed to collect characteristics and attributes of soybean EE2001788.
Therefore, it is unclear if the instant claims are referring to a variety, a line, or a cultivar, or some other genus that encompasses all three of those as subgroups therefore the scope of the claims and metes and bounds of the claims are not defined.
Claim 18 is rejected as being indefinite in their recitation “soybean cultivar EE2001788” because the recitation does not clearly identify the claimed plant cultivar and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “soybean cultivar EE2001788” 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 plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the NCMA deposit number.
Dependent claims 19-20 are also rejected because they fail to overcome the deficiencies of parent claims.
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.
ENABLEMENT regarding Biological Deposit
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 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.
The invention appears to employ the seed of novel plants. Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit thereof. The specification does not disclose a repeatable 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. In the instant case, the Specification has not explicitly stated that subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
Although the rules do not specify a specific number of seeds to be deposited to meet the requirements of these rules, so long as the number of seeds deposited complies with the requirements of the Budapest Treaty International Depositary Authority (IDA) where the deposit is made, the USPTO would consider such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809. Note that the American Type Culture Collection (ATCC), a Budapest IDA, requires a minimum deposit of 625 seeds; other IDAs may have different minimum requirements. Accordingly, any depositor should confirm that the number submitted to a specific IDA complies with that IDA's requirements for seed deposits.
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.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Written Description Requirement regarding Breeding History
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. 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.
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 variety (EE2001788). 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 variety 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, e.g., Table 1 and Table 2. 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 factual evidence above 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 variety.
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).
Conclusion
No claims are allowed.
Claims 1-20 are deemed provisionally free of the prior art, given the failure of the prior art to teach or suggesting a soybean cultivar having all of the morphological and physiological characteristics of the deposited soybean variety EE2001788. It should be noted that this statement is based only on a comparison of the morphological and physiological characteristics of the deposit against the prior art. This is statement is provisional because Applicant has not provided any information regarding the parental lineage or breeding methodology used to produce the deposited soybean variety EE2001788. Without this information, a meaningful comparison of the genetic and phenotypic basis that would distinguish the deposited soybean variety EE2001788 from prior art plants cannot be made. Thus, this statement will remain provisional until the necessary information regarding the parental lineage or breeding methodology above are made to the description, and a complete search of the prior art can be completed.
The closest prior art is Delheimer (US 9730413 B1, 2017) which teaches Soybean cultivar CW1410087. The prior art soybean cultivar shares many physiological and physiological characteristics with the instantly claimed. However, the prior art variety differs from the instantly claimed in at least the Relative Maturity, glyphosate resistance gene, parental lineage, and breeding history.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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 A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/ Primary Examiner, Art Unit 1663