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 .
Priority
The instant application is a divisional of U.S. Application No. 17/974,579, filed on October 27, 2022, which claims the benefit of U.S. Provisional Application No. 63/63310607, filed on February 16, 2022. Acknowledgment is made of applicant' s claim for domestic benefit under 35 U.S.C. 119(e). As such, the effective filing date of Claims 1-17 is February 16, 2022.
Status of the Claims
Claims 1-17 are pending.
Claims 1-17 are examined herein.
Information Disclosure Statement
The Information Disclosure Statement filed on 06/09/2025 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of the list of references cited from the IDS is included with this Office Action.
Specification
The disclosure is objected to because of the following informalities:
The specification on at least pg. 43 lists the accession number under which seeds of claimed soybean varieties are deposited as ATCC Accession Number “____”; and also the date(s) of the deposit for these varieties is missing. These deposit accession numbers are not complete and cannot be used to access the deposited seeds. It is assumed that the blanks will be replaced with the appropriate deposit accession numbers. It is also assumed that the corresponding dates will be inserted.
Appropriate correction is required.
Claim Objections
Claim 10 is objected to because of the following informalities:
In Claim 10, line 2, in the phrase “said soybean plant, or parts thereof of claim 1,” the term “said” should be replaced with “the” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is 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.
In Claim 15, the term “essentially all” renders the claim indefinite. The claim is drawn to a plant produced by the method of Claim 14, wherein the plant comprises a single locus conversion and otherwise comprises essentially all of the morphological characteristics of the recited lines. The specification does not define the term “essentially all”, therefore one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed invention. The term “essentially” is a relative term of approximation and requires specific guidance as to its metes and bounds to be definite. In this case, the specification supplies no guidance or definition such that one of ordinary skill in the art would be able to determine which of the characteristics of the EE2020262 line, including those recited in Table 3, must be retained for the plant of Claim 15 to be deemed to have “essentially all” of the characteristics of said line. Claim 14, from which Claim 15 depends, includes plants that have only one backcross relative to the F1 progeny plants, therefore the plant of Claim 15 is a BCP1 plant that could potentially have significant variation relative to the recurrent parent, due to only inheriting 75% of its genetic material from the recurrent parent. Because the F₁ parent recited in Claim 14 is heterozygous, the BCP₁ generation experiences independent assortment and segregation of alleles. This results in a spectrum of BCP₁ plants, wherein some will resemble the recurrent parent closely, while others will retain significant portions of the donor genome, and as such it is unclear, without further guidance from the instant specification, what characteristics of the recurrent parent (EE2020262 line), including those recited in Table 3, must be retained for the BCP₁ plant of Claim 15 to be deemed to have “essentially all” of the characteristics of said line.
The instant scenario is in contrast to that in In re Marosi, where the phrase "a silicon dioxide source that is essentially free of alkali metal" was held to be definite because the specification contained guidelines and examples that were considered sufficient to enable a person of ordinary skill in the art to draw a line between unavoidable impurities in starting materials and essential ingredients. In re Marosi, 710 F.2d 799, 218 USPQ 289 (CCPA 1983); discussed in MPEP §2173.05(b).
Therefore, it is unclear which physiological and morphological characteristics the plant of claim 15 would possess.
Claim Rejections - 35 USC § 112
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 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.
To claim a genus under the written description requirement, the applicant is required to describe a representative number of species to reflect the variation within the genus or structures sufficient to define the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combinations thereof.
By court' s statement in Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), a written description of an invention “requires a precise definition, such as a structure, formula, or chemical name, of the claimed subject matter sufficient to distinguish it from other materials”; further, a written description of a claimed genus requires a description of a representative number of species of the claimed genus, and one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”.
Claims 13 and 17 are broadly drawn to a genus of plants produced by the method of claim 11, and a seed that produces the plant of Claim 13.
Claim 11 recites introducing at least one transgene or locus conferring the desired trait into the soybean plant EE2020262. However, Claim 11 does not recite introducing a single transgene or locus, but rather “At least one transgene or locus”, which encompasses an unlimited number of transgenes or loci.
The specification describes some morphological characteristics of EE2020262 (pgs. 46-49, Tables 3-4). EE2020262 does not comprise any introduced transgenes or locus conversions. The specification does not provide any example of EE2020262 comprising a transgene or locus conversion, not to mention the common structure feature of the genus of plants or seeds.
In the prior art, Li et al. (Plant Biotechnology Journal, 20, 1110–1121, 2022; IDS Document) teach that an introduced locus conversion comprising a transgene (ST1 locus) dramatically and significantly changes many physiological and morphological characteristics/traits of the original soybean variety (GR8836), and as well as the oil content (pg. 1110, Summary; pgs. 1112-1113, Results).
Thus, an unlimited number of introduced transgenes or locus would dramatically and significantly change many physiological and morphological characteristics/traits of the original soybean variety. As such, the plant produced by the method of Claim 11 would not maintain all of physiological and morphological characteristics of EE2020262.
The structure of EE2020262, and the morphological and physiological characteristics that are connected to the structure does not comprise any transgene, thus does not describe the common structure feature of the genus of converted seeds, plants, plant parts, and does not represent genus of converted seeds, plants, or plant parts.
Therefore, the application has not met either of the two elements of the written description requirement as set forth in the court' s decision in Eli Lilly, and has not shown her/his possession of the claimed genus at the time of the application. Amending Claim 11 to recite “a single transgene or locus” would overcome the rejection.
Additionally, 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 line (EE2020262). So, the examiner will evaluate what is an adequate written description for a new soybean line. 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 of the plant traits as seen in Tables 3-4 (pgs. 47-48) of the instant specification. Applicant has not provided the breeding method for the instantly claimed plant variety in the instant specification, none of the parents used to produce soybean line EE2020262 have been disclosed by Applicant by any name or designation. As such, the breeding history information provided is insufficient; thus, the instant application is incomplete as to the breeding history used to produce the claimed plant variety. If none of the parents were ever in the public domain, then the Applicant must state clearly for the record that the parents are proprietary internal soybean lines that have never been made publicly available and have no other alternative names or designations in the art.
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 U.S.C. § 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 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 siblings or parents of the instant plant are claimed, the serial numbers and names of the siblings 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).
Claim Rejections - 35 USC § 112
Deposit of Biological Material
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 1-17 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 novel soybean plants. Since the plant 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 the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the plant. A deposit of 625 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant and it is not apparent if the plant is readily available to the public.
On page 43 of the specification, Applicant provides a statement indicating the deposit of the seeds of EE2020262 was made with the ATCC, and an intention to meet the terms of 37 C.F.R. 1.801-1.809, there is no statement that the deposit was accepted nor is there a statement indicating that upon issuance of a patent all restrictions on the public availability to the public of the deposit will be irrevocably removed. It is noted that pursuant to MPEP 2409, where a statement is merely an indication that a deposit has been made (with no indication as to whether it has been accepted), there is no assurance that the requirements under 35 U.S.C. 112 have been satisfied. Given that in the instant case, there is no indication that the deposit has been accepted, the deposit requirement is not met.
(a) If a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a 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 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) 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 effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
See MPEP 2404.01: The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
Closest Prior Art
Claims 1-17 appear to be free of the prior art in regard to soybean line EE2020262, barring any evidence to the contrary submitted in response to the 35 U.S.C. 112(a) rejection regarding the instant soybean line’s breeding history and parental genetics. The closest prior art in regard to Claims 1-17 can be found in Schultze and Valera Rojas (US Patent No. 11,122,763 B1, issued 09/21/2021) which teaches soybean variety 5PKEM45 which shares a number of characteristics with instant soybean line EE2020262, including growth habit, flower color, pubescence color, hila color, and pod color. However, soybean variety 5PKEM45 differs from the instant soybean line in at least relative maturity, disease resistances, and herbicide resistances (columns 37-38).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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