Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are examined.
Specification
The specification is objected to for the presence of blank lines in ¶244.
Claim Objections
Claims 1, 11 and 13 are objected to because of the following informalities: each of these claims recite a blank line where the deposit accession number should be. 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.
A. 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.
The claims are indefinite for their recitation of “14150713” because this variety name is not recognized in the art and alone does not clearly identify the claimed soybean variety, seed and plant and thus does not set forth the metes and bounds of the claimed invention. The name of 14150713 does not carry any art recognized limitations with respect to any specific characteristics. Amending claims 1, 11 and 13 to recite the NCMA accession number for soybean variety 14150713 would obviate this rejection. Dependent claims fail to recite additional limitations to overcome the rejection. Their metes and bounds are therefore also unclear.
B. 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.
The claims are indefinite because of the definition of “soybean plant” in (¶186):
When the term "soybean plant" is used in the context of the present invention, this also includes any single gene conversions of that cultivar. The term single gene converted plant as used herein refers to those soybean plants which are developed by a plant breeding technique called backcrossing wherein essentially all of the morphological and physiological characteristics of a cultivar are recovered in addition to the single gene transferred into the cultivar via the backcrossing technique. By "essentially all" as used herein in the context of morphological and physiological characteristics it is meant that the characteristics of a plant are recovered that are otherwise present when compared in the same environment, other than occasional variant traits that might arise during backcrossing or direct introduction of a transgene. It is understood that a locus introduced by backcrossing may or may not be transgenic in origin, and thus the term backcrossing specifically includes backcrossing to introduce loci that were created by genetic transformation.
It is not clear if this definition only applies when the phrase “soybean plant” is used or if it also applies when “soybean cultivar” or “a plant of soybean cultivar” is used.
When “soybean cultivar” is used in this definition, “soybean cultivar” and “soybean plant” appear to be interchangeable terms, as “the term ‘soybean plant’ … includes any single gene conversions of that cultivar” (emphasis added).
Further, the claims use “soybean plant” to refer to “soybean cultivar 14150713”. Claim 11 is a method of introducing a single locus conversion into a soybean plant, where the plant into which the single locus conversion is introduced is a plant of soybean cultivar 14150713.
The recitation “A soybean plant of soybean cultivar 14150713” in claim 13 uses both phrases. In this recitation, “soybean plant”, which by definition “includes any single gene conversions of that cultivar” is a subspecies of “soybean cultivar 14150713”, suggesting that “soybean cultivar 14150713” is even broader than the definition of “soybean plant” in ¶186.
Regardless, the definition of “essentially all of the phenotypic characteristics or morphological and physiological characteristics” in ¶186 indicates that plants with variant traits are encompassed by “single gene conversions” as well as by “soybean plant”, and under the interpretation above, “soybean cultivar”.
It is not clear what is meant by “occasional variant traits”, as it is not clear how the time word “occasional” applies to a product. It is also not clear how many “variant traits” are encompassed by the phrase.
It thus appears from these definitions that a large amount of variation is encompassed by “soybean plant”, and under the interpretation above, “soybean cultivar 14150713” and that “soybean cultivar 14150713” encompasses a genus of plants.
The “soybean plant of soybean cultivar 14150713, further comprising a single locus conversion” recited in claim 13 has a locus or loci converted relative to their own loci and have variants relative to its own genetic background. Similarly, claim 18 requires a mutagenized plant of soybean cultivar 14150713 comprising a mutation. These claims are drawn to circular logic and renders the phrase and definition in ¶186 indefinite. The metes and bounds of what a “locus conversion” of 14150713 and a mutagenized plant of soybean cultivar 14150713 would be is completely unclear, especially because the loci are converted or mutagenized relative to the undefined genus “14150713”.
Further, it is not clear how many of these variations and conversions it takes for the plant to no longer be a member of the genus of plants encompassed by “soybean plant” or named “soybean cultivar 14150713”.
If the phrase “soybean plant” does not encompass “soybean cultivar”, it is not clear if the definition in ¶186 only applies when “soybean plant” is used or if “soybean seed” is also encompassed. The definition of “plant” includes “seeds” (¶55):
[0055] Plant. As used herein, the term "plant" includes reference to an immature or mature whole plant, including a plant from which seed, grain, or anthers have been removed. Seed or embryo that will produce the plant is also considered to be the plant.
For purposes of examination, it was assumed that both “soybean plant” and “soybean seed” “includes any single gene conversions of that cultivar”. Such treatment does not relieve Applicant of the responsibility to respond to this rejection.
Claims 11 and 13 are indefinite in their recitation of “single locus conversion”.
The specification defines “Single Locus Converted (Conversion)” as follows (¶68):
[0068] Single Locus Converted (Conversion). Single locus converted (conversion), also known as coisogenic plants, refers to plants which are developed by a plant breeding technique called backcrossing and/or by genetic transformation to introduce a given locus that is transgenic in origin, wherein essentially all of the morphological and physiological characteristics of a soybean variety are recovered in addition to the characteristics of the locus transferred into the variety via the backcrossing technique or by genetic transformation.
It is not clear from the phrase “introduce a given locus that is transgenic in origin” if the locus introduced by either backcrossing or transformation is limited to those that are “transgenic in origin” or if the locus introduced by backcrossing can be non-transgenic.
Lastly, it is not clear if “a single locus conversion” means one and only one locus conversion. The specification defines “a” as follows (¶243):
[00243] The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to,") unless otherwise noted.
This definition implies multiple locus conversions are encompassed by the phrase. However, the word “single” implies one and only one locus conversion.
This is further made confusing in claim 13, which is drawn to a “soybean plant of soybean cultivar 14150713, further comprising a single locus conversion”. As discussed above, “soybean plant”, under any interpretation, “includes any single gene conversions”. In claim 13 the soybean plant with single gene conversions further comprises a single locus conversion. It is unclear how many gene conversions are encompassed by the claimed plant, and how many loci are different from those in “soybean cultivar 14150713”, if “soybean cultivar 14150713” is not itself a genus.
Claims 10 and 13 are indefinite in their recitation of “otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 14150713”. Because it is not clear what is encompassed by “soybean cultivar 14150713”, it is not clear what its morphological and physiological characteristics are.
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 1-20 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 claims all require seed of soybean cultivar 14150713.
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.
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 a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
It is noted that Applicant states that seeds for soybean cultivar 14150713 are deposited at the NCMA, (¶244), but there is no deposit number. It is thus not clear that the seeds have actually been deposited.
If the deposit of these seeds is made and accepted under the terms of the Budapest Treaty, then that and a statement of that by an attorney of record over his or her signature and registration number would satisfy the deposit requirement made herein.
If the deposit is not made and accepted under the Budapest Treaty, then in order to certify that the deposit, meets the requirements 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; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Written Description
A. 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 that 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The definitions and interpretations of the phrases “soybean plant”, “soybean seed”, “soybean cultivar 14150713”and “single gene conversion” presented in the rejection under 35 U.S.C. 112(b) above are incorporated herein.
The instant claims are broadly drawn to plants and seeds of soybean cultivar 14150713, and plants and seed derived from said cultivar, and methods of using said cultivar.
Under the interpretation that “soybean cultivar 14150713” encompasses “any single gene conversions of that cultivar”, the specification does not describe the full scope of 14150713 plants with unspecified numbers of locus conversions and mutations relative to the plant described in Table 1 or the plant whose seeds are to be deposited.
The recitation in (¶186) that “single gene converted plant” “refers to those soybean plants which are developed by a plant breeding technique called backcrossing wherein essentially all of the morphological and physiological characteristics of a cultivar are recovered in addition to the single gene transferred into the cultivar” means that plants with variant traits are encompassed by “single gene conversions” as well as by “soybean plant” and “soybean cultivar”.
The specification does not describe soybean plants with an unspecified number of “variant traits” relative to “soybean cultivar 14150713”, whether “soybean cultivar 14150713” means only plants with a single fixed genome or plants that are some genera of genetics and/or morphological and physiological characteristics.
Under the interpretation that “soybean plant” means a plant includes any single gene conversions only when the phrase “soybean plant” is recited, the specification does not describe soybean cultivar 14150713 plants further comprising a single locus conversion.
As single locus converted plants “have essentially all of the morphological and physiological characteristics of a soybean variety” (¶68), single locus converted plants of soybean cultivar 14150713 have an unspecified number of differences from plants soybean cultivar 14150713. Further, claim 13, which is drawn to a “soybean plant of soybean cultivar 14150713, further comprising a single locus conversion” encompasses a cultivar 14150713 soybean plant with single gene conversions further comprising a single locus conversion. Similarly, claim 18 requires a mutagenized plant of soybean cultivar 14150713 comprising a mutation.
The specification describes no structural features that distinguish plants of “soybean cultivar 14150713” from other soybean plants. The specification does not describe the structural features and/or morphological and physiological characteristics that are required for a plant to be of “soybean cultivar 14150713”.
The specification describes no structural features that distinguish plants of “soybean cultivar 14150713, further comprising a single locus conversion” from other soybean plants. The specification does not describe the structural features and/or morphological and physiological characteristics that are required for a plant to be of “soybean cultivar 14150713 further comprising a single locus conversion”.
Thus, the claim encompasses soybean plants that can have almost any number of mutations in any number of morphological and physiological characteristics relative to soybean cultivar 14150713, regardless how broadly “soybean cultivar 14150713” is interpreted.
The specification describes no structural features that distinguish soybean plants that differ in any number of morphological and physiological characteristics from soybean cultivar 14150713 from other soybean plants.
The specification describes no plants that differ from morphological and physiological characteristics of soybean cultivar 14150713 in an unspecified number of traits. The specification only describes soybean cultivar 14150713 (Table 1).
Hence, Applicant has not, in fact, described the claimed soybean plants over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Missing Breeding History
B. 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 instant Specification fails to satisfy the
written description requirement of 35 U.S. Code § 112(a) because it does not provide a description
sufficient to conduct an examination, including search of the prior art, nor does it provide enough
description to be sufficient to aid in the resolution of questions of infringement.
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).
In the instant application, a full examination cannot be conducted. Applicant claims a new soybean cultivar. A plant cultivar is defined by both its genetics (breeding history) and its traits. In the instant application, Applicant has provided a description of the plant traits as seen in the specification. While Applicant has provided the breeding history for the instantly claimed plant cultivar, the one of the parents used to produce it is not known in the art, at least under the name provided. The instant application is thus incomplete as to the breeding history used to produce the claimed plant cultivar.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. 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” (USDA, “Applying for a Plant Variety Certificate of Protection”, https://www.ams.usda.gov/services/pvpo/application-help/apply, accessed 1 May 2023). Additionally, 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, 2017, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, see notes 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. 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) and Ex Parte McGowen, Board Decision in Application 14/996,093, 2020). 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.
Moreover, a specification with an incomplete 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 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 phenotype of the claimed plant for assessing potential infringement.
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. The assumption that elite cultivars are composed of relatively homogenous genetic pools is false (Haun et al, 2011, Plant Physiol. 155:645-655; see pg 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 (pg 645, right column, paragraph 2, to pg 646, left column, paragraph 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al, 2015, J. Exp. Bot. 66:5429-5440; see pg 5430 left column, paragraph 2, and right column, paragraph 2). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant.
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 to identify all names for all parental lines utilized in the development of the instant cultivar. For example, if Applicant’s breeding history uses proprietary line names, Applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line 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 either 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(s) as well (i.e., grandparents).
Applicant is also reminded of the 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 variety).
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
Claims 1-20 are rejected.
The prior closest art is Mason (US 10499596), which teaches soybean variety 76034331. The morphological traits of the instantly claimed variety and variety 76034331 are similar (Table 1 of instant specification and of ‘596). However, the instantly claimed variety and variety 11050808 are produced by crossing distinct lines (paragraph 68 of instant Specification; column 6 of ‘692), therefore the genetics of the cultivars are distinct.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID R BYRNES/Examiner, Art Unit 1662
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