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 disclosure is objected to because of the following informalities: the presence of blank lines in ¶253.
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 the second paragraph of 35 U.S.C. 112:
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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claims 1, 11 and 13 are indefinite because of the presence of a blank line instead of a NCMA Accession No. Because the number is not present and the deposit not perfected, it is unclear to which deposit the claims refer.
Claims 1, 6, 10-11, 13, and 16-17 are indefinite in their recitation of “soybean cultivar 23450402”. Without the deposit number in the independent claims, it is unclear what soybean is being referred to.
Further, the claims are indefinite because of the definition of “soybean plant” in (¶195):
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 23450402”. 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 23450402.
The recitation “A soybean plant of soybean cultivar 23450402” 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 23450402”, suggesting that “soybean cultivar 23450402” is even broader than the definition of “soybean plant” in ¶195.
Regardless, the definition of “essentially all of the phenotypic characteristics or morphological and physiological characteristics” in ¶195 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 an unclear amount of variation is encompassed by “soybean plant”, and under the interpretation above, “soybean cultivar 23450402” and that “soybean cultivar 23450402” encompasses a genus of plants, of which the metes and bounds are unclear.
The “soybean plant of soybean cultivar 23450402, 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. This is circular logic and renders this phrase and definition in ¶195 indefinite. The metes and bounds of what a “locus conversion” of 23450402 would be is completely unclear, especially since the loci are converted relative to the undefined genus “23450402”.
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 23450402”.
If the phrase “soybean plant” does not encompass “soybean cultivar”, it is not clear if the definition in ¶195 only applies when “soybean plant” is used or if “soybean seed” is also encompassed. The definition of “plant” includes “seeds” (¶55):
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):
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 (¶252):
[00252] 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 unclear in claim 13, which is drawn to a “soybean plant of soybean cultivar 23450402, 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 23450402”, if “soybean cultivar 23450402” 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 23450402”. Because it is not clear what is encompassed by “soybean cultivar 23450402”, it is not clear what its morphological and physiological characteristics are.
Claims 2-5, 7-9, 12, 14-15 and 18-20 depend from claims 1 and 11 and fail to recite additional limitations that make the metes and bounds of the claimed invention clear. Therefore, they are also indefinite.
Enablement
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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 that 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 23450402.
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 23450402 are deposited at the NCMA (¶253), 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
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 claims contain 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.
A. The specification does not describe soybean plants with an unspecified number of “variant traits” relative to “soybean cultivar 23450402”
The definitions and interpretations of the phrases “soybean plant”, “soybean seed”, “soybean cultivar 23450402”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 23450402, and plants and seed derived from said cultivar, and methods of using said cultivar.
Under the interpretation that “soybean cultivar 23450402” encompasses “any single gene conversions of that cultivar”, the specification does not describe the full scope of 23450402 plants with unspecified numbers of locus conversions relative to the plant describe in Table 1 or the plant whose seeds are to be deposited.
The recitation in (¶195) 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 23450402”, whether “soybean cultivar 23450402” means only plants with a single fixed genome or plants that are some genus 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 23450402 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 23450402 have an unspecified number of differences from plants soybean cultivar 23450402. Further, claim 13, which is drawn to a “soybean plant of soybean cultivar 23450402, further comprising a single locus conversion” encompasses a cultivar 23450402 soybean plant with single gene conversions further comprising a single locus conversion.
The specification describes no structural features that distinguish plants of “soybean cultivar 23450402” 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 23450402”.
The specification describes no structural features that distinguish plants of “soybean cultivar 23450402, 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 23450402 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 23450402, regardless how broadly “soybean cultivar 23450402” 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 23450402 from other soybean plants.
The specification describes no plants that differ from morphological and physiological characteristics of soybean cultivar 23450402 in an unspecified number of traits. The specification only describes soybean cultivar 23450402 (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. 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 because applicant failed to provide the complete breeding history for the instantly claimed plant variety. Specifically, Applicant claims a new soybean cultivar. A plant cultivar is defined by both its genetics (i.e., its breeding history) and its traits. In the instant application, Applicant has provided a description of the plant traits as seen in the specification (Table 1) and how it was made (¶69); however, parent 6007-13 is not described in the prior art, at least under the name provided. Parent 15XT305015-02 is described in the art (US 10548273) and is known by the alternate name of Soybean Cultivar 87120510; however, it is not clear if there are other designations for this parent line. The instant application is thus incomplete as to the breeding history used to produce the claimed plant variety.
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 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 provide the complete 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. 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 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 is also 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 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).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eby (US 10548273; hereinafter referred to as ‘273) in view of De Beuckeleer (US 8017756) and Narvel (US 7566821).
The definitions and interpretations of the phrases “soybean plant’, “soybean seed”, “soybean cultivar 23450402” and “single gene conversion” presented in the rejection under 35 U.S.C. 112(b) above are incorporated herein.
Instant claims 1-17 are identical to claims 1-17 of ‘273, respectively, except for the name of the variety. Instant claims 18-19 are drawn to a method of determining the genotype of the plant claim 1. Instant claim 20 is drawn to a method of producing a commodity plant product of the plant of claim 1.
‘273 teaches a soybean plant 87120510, also known as 15XT305015-02, which shares many characteristics with the instantly claimed soybean plant. From the limited breeding history provided by Applicant, the plant of ‘273 appears to differ from the instantly claimed plant only by a cross with a plant not known in the art, “6007-13”, which was then backcrossed to the plant of ‘273. ‘273 teaches using markers to distinguish varieties (column 22, lines 39-44).
The instantly claimed plant differs from the patented plant of ‘273 by the color of the pod wall being tan instead of brown, comprising event A5547-127 and Phytophthora Root Rot resistance gene RPS3a. Additionally, there are differences reported in quantitative traits: relative maturity, plant lodging, seed size, seed % protein and seed % oil and the plant of ‘273 comprises Soybean Cyst Nematode resistance gene rhg 1; however, the instantly claimed plant is silent regarding whether this resistance trait is comprised. It is not clear if the differences in quantitative traits are bona fide differences as one would expect variation in each of these traits so it is not possible to distinguish which differences are due to environmental differences or underlying genetic traits.
De Beuckeleer teaches modifying soybean plants to comprise event A5547-127 for herbicide tolerance to complement the agronomic performance of the background soybean plant into which the event would be introduced (column 1, lines 15-25). De Beuckeleer teaches identifying in biological samples the presence of plant material comprising event A5547-127 (column 1, lines 15-25).
Narvel teaches a soybean plant comprising a tan pod wall and Phytophthora Root Rot resistance gene RPS3a (Table 1).
It would have been prima facie obvious at the time of filing to combine the teachings of ‘273 with De Beuckeleer and Narvel to arrive at the claimed invention. One would have been motivated to modify a soybean plant to comprise A5547-127 for herbicide tolerance to complement the agronomic performance of the background soybean plant into which the event would be introduced. One of ordinary skill in the art would have expected to be able to grow the resulting soybean plant with reduced weed pressure by applying the herbicide to which the soybean plant would then be resistant as a result. One would have been motivated to introgress the Phytophthora Root Rot resistance gene RPS3a as comprised by the soybean plant taught by Narvel to introgress this additional resistance trait into the resulting plant in order to be able to grow in the presence of additional phytophthora races. The selection of a brown or a tan pod color would have been a mere design choice which would have been obvious to a breeder crossing the plant of ‘273 with the plant of Narvel to select for if it was desirable for any reason with the expectation of the resulting plant comprising both RPS3a and a tan pod color. Further, it would have been obvious to use markers to distinguish the instantly claimed variety from other varieties as taught by ‘273.
Therefore, instant claims 1-20 are obvious in light of the teachings and suggestions of the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/436,608 (US 20250255260; hereinafter, “‘608”). Although the claims at issue are not identical, they are not patentably distinct from each other.
The definitions and interpretations of the phrases “soybean plant’, “soybean seed”, “soybean cultivar 23450402” and “single gene conversion” presented in the rejection under 35 U.S.C. 112(b) above are incorporated herein.
Instant claims 1-20 are identical to claims 1-20 of ‘608, respectively, except for the name of the variety.
‘608 claims a soybean variety, 23240202, that like the instantly claimed plant has (Table 1) yellow, dull seed coats, yellow cotyledons, ovate leaflets, an indeterminate growth habit, purple flowers, black hila, light tawny pubescence, tan pod color, the GM_A19788, GM_A92205, A5547-127, Phytophthora Root Rot resistance Rps 1c and Rps 3a and similar values as the instantly claimed plant for the environmentally-affected traits relative maturity, lodging, height, seeds/lb, seed protein % and seed oil % (Table 1 and the two paragraphs immediately following). It is not clear if the differences in quantitative traits are bona fide differences as one would expect variation in each of these traits so it is not possible to distinguish which differences are due to environmental differences or underlying genetic traits.
Additionally, the plant ‘608 and the instant variety were both produced by an initial cross between 15XT305015-02 and 6007-13 followed by a backcross to 15XT305015-02 (paragraph 69 of instant Specification and ‘630).
Therefore, it is unclear whether there is any difference genotypically or phenotypically between the instantly claimed plant and the plant claimed by the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
B. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/436,630 (US 20250255262; hereinafter, “‘630”). Although the claims at issue are not identical, they are not patentably distinct from each other.
The definitions and interpretations of the phrases “soybean plant’, “soybean seed”, “soybean cultivar 23450402” and “single gene conversion” presented in the rejection under 35 U.S.C. 112(b) above are incorporated herein.
Instant claims 1-20 are identical to claims 1-20 of ‘630, respectively, except for the name of the variety.
‘630 claims a soybean variety, 20372402, that like the instantly claimed plant has (Table 1) yellow, dull seed coats, yellow cotyledons, ovate leaflets, an indeterminate growth habit, purple flowers, black hila, light tawny pubescence, tan pod color, the GM_A19788, GM_A92205, A5547-127, Phytophthora Root Rot resistance Rps 1c and Rps 3a and similar values as the instantly claimed plant for the environmentally-affected traits relative maturity, lodging, height, seeds/lb, seed protein % and seed oil % (Table 1 and the two paragraphs immediately following). It is not clear if the differences in quantitative traits are bona fide differences as one would expect variation in each of these traits so it is not possible to distinguish which differences are due to environmental differences or underlying genetic traits. The maturity group of the instantly claimed variety is I whereas the plant of ‘630 has a maturity group of 0.
Additionally, the plant ‘630 and the instant variety were both produced by an initial cross between 15XT305015-02 and 6007-13 followed by a backcross to 15XT305015-02 (paragraph 69 of instant Specification and ‘630).
Therefore, it is unclear whether there is any difference genotypically or phenotypically between the instantly claimed plant and the plant claimed by the copending application.
If the difference in maturity group between the instantly claimed variety and the plant of ‘630 is in fact genetic and a bona fide difference between the two plants, it would have been prima facie obvious at the time of filing to modify the maturity group of the instantly claimed variety as a mere design choice. One of ordinary skill in the art would expect that doing so may be commercially important for growers to optimize their production of soybean.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
C. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/436,649 (US 20250255260; hereinafter, “‘649”). Although the claims at issue are not identical, they are not patentably distinct from each other.
The definitions and interpretations of the phrases “soybean plant’, “soybean seed”, “soybean cultivar 23450402” and “single gene conversion” presented in the rejection under 35 U.S.C. 112(b) above are incorporated herein.
Instant claims 1-20 are identical to claims 1-20 of ‘649, respectively, except for the name of the variety.
‘649 claims a soybean variety, 21382402, that like the instantly claimed plant has (Table 1) yellow, dull seed coats, yellow cotyledons, ovate leaflets, an indeterminate growth habit, purple flowers, black hila, light tawny pubescence, tan pod color, the GM_A19788, GM_A92205, A5547-127, Phytophthora Root Rot resistance Rps 1c and Rps 3a and similar values as the instantly claimed plant for the environmentally-affected traits relative maturity, lodging, height, seeds/lb, seed protein % and seed oil % (Table 1 and the two paragraphs immediately following). It is not clear if the differences in quantitative traits are bona fide differences as one would expect variation in each of these traits so it is not possible to distinguish which differences are due to environmental differences or underlying genetic traits. The maturity group of the instantly claimed variety is I whereas the plant of ‘630 has a maturity group of 0.
Additionally, the plant ‘649 and the instant variety were both produced by an initial cross between 15XT305015-02 and 6007-13 followed by a backcross to 15XT305015-02 (paragraph 69 of instant Specification and paragraph 70 of ‘649).
Therefore, it is unclear whether there is any difference genotypically or phenotypically between the instantly claimed plant and the plant claimed by the copending application.
If the difference in maturity group between the instantly claimed variety and the plant of ‘630 is in fact genetic and a bona fide difference between the two plants, it would have been prima facie obvious at the time of filing to modify the maturity group of the instantly claimed variety as a mere design choice. One of ordinary skill in the art would expect that doing so may be commercially important for growers to optimize their production of soybean.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/DAVID R BYRNES/Examiner, Art Unit 1662