DETAILED ACTION
Claims 1-2, 6-16, and 22-25 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The objection to claims 1 and 9 because each of these claims recites “NCMA Accession No. 202110013” but this accession does not conform to 37 CFR 1.801 is withdrawn in light of Applicant’s amendment to the claims.
The warning that should claim 5 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 1-27 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al (2020, US Patent No. 10,772,282) is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 1-27 under 35 U.S.C. 101 as claiming the same invention as that of or, in the alternative on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,772,282) is withdrawn in light of Applicant’s amendment to the claims.
Claim Objections
Applicant is advised that should claims 1 and 2 be found allowable, claims 10 and 11, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Both sets of claims are drawn to a population of seeds or plants of alfalfa variety R413A114, wherein a population of plants produced from the population of seeds has all of the physiological and morphological characteristics of said alfalfa variety R413A114.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 6-16, and 22-25 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. All dependent claims are included in the rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 7 July 2025, as applied to claims 1-27. Applicant’s arguments and the Ma Declaration, both filed 7 October 2025, have been fully considered but they are not persuasive.
It is unclear what it means for a population to have “all of the physiological and morphological characteristics of said alfalfa variety R413A114”.
R413A114 is a synthetic variety encompassing a diverse and very heterogeneous population of alfalfa plants resulting from crosses of 220 separate parent plants (¶16).
The specification describes some of the characteristics of the R413A114 population in Tables 1-17 and ¶14-20. ¶19 describes the R413A114 population as having high resistance to anthracnose (Race 1), bacterial wilt, fusarium wilt, verticillium wilt, Phytophthora root rot, Aphanomyces root rot (Race 1), and Aphanomyces root rot (Race 2), as having resistance to spotted alfalfa aphid, and as having moderate resistance to stem nematode and pea aphid (¶20). In Tables 8-17, the specification indicates that “high resistance” means >50% of the plants in the population are resistant and that “resistance” means 31-50% of the plants in the population are resistant, and that “moderate resistance” means 15-30% of the plants in the population are resistant. Tables 8-17 provide both those general ratings for resistance for those traits as well as specific percentages; for example, Table 9 indicates that 63% of the R413A114 population is resistant to bacterial wilt. It is not clear if the R413A114 population must be merely resistant or highly resistant to these diseases and pests as summarized in ¶20 or if the population must have the exact resistance percentages listed in Tables 8-17.
It is not clear if the R413A114 population must have the exact total yield, annual yield, persistence, fall dormancy rating, winter survival rating, multifoliate leaf expression, and glyphosate tolerance rating reported in Tables 1-7. The data in these Tables shows a strong effect of environmental conditions. For example, yield ranged from 7.89 to 12.88 (Table 1). It is not clear what the values the R413A114 population must have for these traits to have all the physiological and morphological characteristics of alfalfa variety R413A114.
For example, Table 7 indicates both that the glyphosate tolerance rating for the R413A114 population is HT, which is not defined in the table, and that 91% of the plants are glyphosate tolerant. It is not clear which standard the R413A114 population must have to have all the physiological and morphological characteristics of alfalfa variety R413A114.
It is also unclear if one killed all the non-glyphosate tolerant plants in the population, so that 100% of the population were glyphosate tolerant, would population be encompassed by the claim?
Similarly, it is not clear if the R413A114 population must have the exact percentages of flower color listed in ¶17 or if any variation is permitted. It is also unclear what percentage a “trace” of variegated and white colors is and how large the population must be to have those exact percentages. Note that 97% purple, 1% cream, and 1% yellow add up to 99%; Are the variegated and white colors each present in 0.5% of the plants or all the cited percentages an unspecified fraction greater or lesser than those described in the specification?
If the R413A114 population must have the exact percentages and values listed in ¶17, Tables 1-17, and R413A114’s undisclosed phenotypic traits, it is not clear if one had a population of alfalfa seeds or plants with a percentage or value for one of these traits that differed, for example, by 1%, if that population would be encompassed by the claims. If one has a single R413A114 seed or plant or a R413A114 subpopulation that is too small to have these percentages of the physiological and morphological characteristics of alfalfa variety R413A114, it is not clear if this plant or subpopulation would be encompassed by the claims.
It is also not clear if “all of the physiological and morphological characteristics of alfalfa variety R413A114” only means the characteristics described in Tables 1-17 and ¶14-20 or if includes all the non-described characteristics of alfalfa variety R413A114, like detergent fiber concentration, relative feed value, and salt tolerance. It is also unclear what the values these latter traits are for R413A114. They can only be described if the deposit has enough seeds in it to accurately reflect these values. One of skill in the art could only determine what these values are for R413A114 if a single packet of seeds is large enough to accurately reflect these values. That does not appear to be case.
Tt is unclear how many plants and seeds must be in the population to produce the exact percentages present in R413A114, and it is unclear if one had one fewer plant or seed than that if that population would be encompassed by the claim.
It is unclear how the deposit represents the claimed population, as no given seed or 25-seed packet of seeds will grow into a population with all the physiological and morphological characteristics of alfalfa variety R413A114.
Claims 15-16 are indefinite in its recitation of “wherein the population of alfalfa plants produced comprises the transgene”. It is unclear if every plant in the population must have the transgene or if only one plant is required to have it.
Therefore, the metes and bounds of the claims are indefinite.
Response to Arguments
Applicant urges that the physiological and morphological characteristics that define the claimed populations of alfalfa variety R413A114 are clearly described in the specification as-filed. See, e.g. paragraphs ¶14-19 and Tables 1-17 (response pg 9).
This is not found persuasive. It is not clear if the R413A114 population must have the exact percentages and values listed in Tables 1-17 and ¶14-20 or if any variation from those percentages is permitted. It is not clear if it is sufficient for the population to have “high resistance” or “resistance” to various diseases and pests as summarized in ¶20 or if it must have the exact percentages listed in Tables 7-16. For example, must the population only have “high resistance” to anthracnose (Race 1) (i.e., where >50% - 100% of the plants in the population have the resistance) or must exactly 73% the population have resistance to anthracnose (Race 1), as disclosed in Table 8?
Applicant urges and the Declaration states that R413A114 was tested against "Standard Check Varieties" and the results of and statistics from such tests are provided in the application and phenotypically characterize the populations of plants as claimed (response pg 9; Declaration ¶7).
This is not found persuasive. The NAAIC guidelines do not clarify if a variety must have the specific percentages recited in Tables 1-17 or if a variety only need to have the broad ranges encompassed by “high resistance”, “resistance”, “moderate resistance”, “moderately winterhardy”, etc. The guidelines do not clarify if the population must have R413A114’s undisclosed phenotypic traits and at what percentages they must be at.
Applicant urges that and the Declaration states that a population of plants of alfalfa variety R413A114 is adapted to the North Central and East Central regions and is Moderately Winterhardy, is Fall Dormant, contains event J-101, is highly resistant to anthracnose (Race 1), bacterial wilt, Fusarium wilt, Verticillium wilt, Phytophthora root rot, Aphanomyces root rot (Race 1), Aphanomyces root rot (Race 2), with resistance to spotted alfalfa aphid and moderate resistance to stem nematode and pea aphid, as defined by industry standard testing guidelines; thus, the scope of the claimed populations of alfalfa variety R413A114 is clear and definite (response pg 9-10; Declaration ¶6).
This is not found persuasive. It is not clear if the population must merely be “adapted to” the cited regions, be fall dormant, have events J-101 in just one plant, and be highly resistant, resistant or moderately resistant to the listed pathogens and pests or if it must have the exact adaptions, dormancy, and percentages in Tables 1-17.
Further, from these standards it appears that a variety is only certified by phenotype. It is not clear if the genetics of R413A114 are required or how much variation from the trait percentages in in specification are permitted. It is unclear if the population must have R413A114’s undisclosed phenotypic traits and at what percentages they must be at.
It is also unclear how large a population must be to have the traits in specification at the recited percentages and have the other traits of alfalfa variety R413A114 not in the specification at whatever percentage those traits are present in R413A114.
Applicant urges and the Declaration states that evaluation and characterization of populations of alfalfa varieties is routine in the art; the at least deposited 625 seeds are sufficient to allow a skilled artisan to readily produce populations of plants of variety R413A114 having all of the characteristics described in Tables 1-17 and distinguish R413A114 from other alfalfa varieties (response pg 10; Declaration ¶3, 8).
This is not found persuasive. The NAAIC guidelines do not clarify if a variety must have the specific percentages recited in Tables 1-17 or if a variety only need to have the broad ranges encompassed by “high resistance”, “resistance”, “moderate resistance”, “moderately winterhardy”, etc. The guidelines do not clarify if the population must have R413A114’s undisclosed phenotypic traits and at what percentages they must be at.
Applicant and Declarant have not provided any evidence that a deposit of 625 seeds is sufficient to both produce the claimed populations of plants as well as distinguish the claimed populations from any other known alfalfa varieties. This statement is thus treated as unsupported opinion. Further, those 625 seeds are stored and provided as 25-seed packets. It is unclear how any given seed or 25-seed packet is “representative” of a population of the variety, which encompasses a diverse and very heterogeneous population of alfalfa plants resulting from crosses among 220 separate parent plants (¶16).
Applicant urges that those skilled in the art are well aware of the industry-standard testing guidelines published by the NAAIC, which specify the required number of plants and replicates for each of the various trials evaluating alfalfa populations for pest resistance and agronomic traits and those skilled in the art are capable of both producing the claimed populations and using the deposited seed to distinguish alfalfa variety R413A114 from other alfalfa varieties, consistent with Dr. Ma's declaratory evidence (response pg 10).
This is not found persuasive for the reasons above.
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 1-2, 6-16, and 22-25 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 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 7 July 2025, as applied to claims 1-27. Applicant’s arguments and the Ma Declaration, both filed 7 October 2025, have been fully considered but they are not persuasive.
The claims require a population of seeds of alfalfa variety R413A114, wherein representative seed of said alfalfa variety have been deposited under NCMA Accession No. 202111013 and wherein a population of plants produced from the population of seeds has all of the physiological and morphological characteristics of said alfalfa variety R413A114.
Plants of alfalfa variety R413A114 are not described
The claims all require a plant or seed of alfalfa variety R413A114.
Alfalfa variety R413A114 is a synthetic variety encompassing an extremely large genus of plants produced by a random mating open pollination of 220 parental plants (¶16).
The specification describes some of the characteristics of the R413A114 population in Tables 1-17 and ¶14-20.
As discussed in the indefiniteness rejection above, and incorporated herein, it is not clear if the R413A114 population must have the exact percentages and ratings as listed in Tables 1-17 and ¶14-20, or if the lower standard of “high resistance”, “resistance”, etc, are encompassed.
The specification only describes a population of alfalfa plants with 97% purple, 1% cream, 1% yellow, and a “trace” of variegated and white flower colors (¶17), 100/81 persistence (Table 3), a fall dormancy rating of 4.2 (Table 4), a winter survival rating of 2.1-2.2 (Table 5), with 83% of the plants having multifolate leaf expression (Table 6), 91% having the J-101 glyphosate resistance event (Table 7), 73% having anthracnose (Race 1) resistance (Table 8), 63% having bacterial wilt resistance (Table 9), 66% having Fusarium wilt resistance (Table 10), 55% having Verticillium wilt resistance (Table 11), 59% having Phytophthora root rot resistance (Table 12), 58% having Aphanomyces root rot (Race 1) resistance (Table 13), 25% having pea aphid resistance (Table 14), 35% having spotted alfalfa aphid resistance (Table 15), 18% having stem nematode resistance (Table 16), 63% having Aphanomyces root rot (Race 2) resistance (Table 17),a yield that varies by year and location grown (Tables 1-2), and an unspecified percents of nondisclosed characteristics.
The specification describes no populations of alfalfa plants with any variation in any of these percentages.
The structural features that distinguish a population of plants of alfalfa variety R413A114 from other populations of alfalfa plants are not described in the specification.
Hence, Applicant has not, in fact, described the claimed population of plants of alfalfa variety R413A114, and the specification fails to provide an adequate written description of the claimed invention.
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 to conduct an examination, including search of the prior art
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.").”
The instant Specification fails to satisfy the written description because it does not provide enough description to be sufficient to aid in the resolution of questions of infringement.
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, applicant failed to provide the breeding history for the instantly claimed plant variety. Specifically, applicant claims a new alfalfa variety. A plant variety is defined by both its genetics (breeding history) and its traits. In the instant specification, applicant has only provided a description of the plant traits (¶14-20 and Tables 1-17). The instant specification is silent or 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 devoid of a 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 phenotypes of the claimed plants for assessing potential infringement.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, applicant must amend the specification/drawing to provide the breeding history used to develop the instant variety or 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 variety. For alfalfa, this should include the locations and years the parents were obtained from.
Response to Arguments
Part A
Applicant urges that the claimed population of plants is adapted to the North Central and East Central regions and is Moderately Winterhardy, is Fall Dormant, contains event J-101, is highly resistant to anthracnose (Race 1), bacterial wilt, Fusarium wilt, Verticillium wilt, Phytophthora root rot, Aphanomyces root rot (Race 1), Aphanomyces root rot (Race 2), with resistance to spotted alfalfa aphid and moderate resistance to stem nematode and pea aphid, as defined by industry standard testing guidelines; thus, the scope of the claimed populations of alfalfa variety R413A114 is clear and definite (response pg 11).
This is not found persuasive.
The specification only describes a population of alfalfa plants with 97% purple, 1% cream, 1% yellow, and a “trace” of variegated and white flower colors (¶17), 100/81 persistence (Table 3), a fall dormancy rating of 4.2 (Table 4), a winter survival rating of 2.1-2.2 (Table 5), with 83% of the plants having multifolate leaf expression (Table 6), 91% having the J-101 glyphosate resistance event (Table 7), 73% having anthracnose (Race 1) resistance (Table 8), 63% having bacterial wilt resistance (Table 9), 66% having Fusarium wilt resistance (Table 10), 55% having Verticillium wilt resistance (Table 11), 59% having Phytophthora root rot resistance (Table 12), 58% having Aphanomyces root rot (Race 1) resistance (Table 13), 25% having pea aphid resistance (Table 14), 35% having spotted alfalfa aphid resistance (Table 15), 18% having stem nematode resistance (Table 16), 63% having Aphanomyces root rot (Race 2) resistance (Table 17),a yield that varies by year and location grown (Tables 1-2), and an unspecified percents of nondisclosed characteristics.
The specification does not describe the full scope of populations of alfalfa plants with flower color percentages other than 97% purple, 1% cream, 1% yellow, and a “trace” of variegated and white flower colors, a persistence other than 100/81, a fall dormancy rating of the full scope of numbers above 4, a winter survival rating of any very winterhardy rating other than 2.1-2.2, with the plants having a multifolate leaf score of 2.80-3.80 (Table 6), with >50-100% having the J-101 glyphosate resistance event (Table 7), >50-100% having anthracnose (Race 1) resistance (Table 8), >50-100% having bacterial wilt resistance (Table 9), >50-100% having Fusarium wilt resistance (Table 10), >50-100% having Verticillium wilt resistance (Table 11), >50-100% having Phytophthora root rot resistance (Table 12), >50-100% having Aphanomyces root rot (Race 1) resistance (Table 13), >50-100% having Aphanomyces root rot (Race 2) resistance (Table 17), 15-30% having stem nematode resistance (Table 16), 15-30% having pea aphid resistance (Table 14), 31-50% having spotted alfalfa aphid resistance (Table 15), a yield that varies by year a location grown (Tables 1-2), , and an unspecified percents of nondisclosed characteristics (see the legends of Tables 1-17 for the definitions of “very winterhardy”, “high resistance”, “resistance”, etc).
Applicant urges and the Declaration states that Rumbaugh also discusses that varieties are always approaching RME, when not subjected to selection pressure and Mabin discusses plausible reasons why a difference in the expected and observed heterogeneity was observed in their study; the development of alfalfa variety R413A114 included breeding and harvesting in isolation; and those skilled in the art are well aware of the procedures and techniques needed to promote random mating equilibrium (response pg 11; Declaration ¶5).
This is not found persuasive because the specification does not describe the full scope of alfalfa plant populations with phenotypic trait ranges recited above.
The Declaration states that observations in the Rumbaugh and Mabin references do not change the fact that the physiological and morphological characteristics of a population of plants of alfalfa variety R413A114 are described in the specification and such characteristics can be maintained in progeny plants, consistent with industry standards and certifications; alfalfa variety R413A114 seed has been certified by the Alfalfa and Miscellaneous Legumes Variety Review Board and the characteristics of this variety are described as distinct and stable (Declaration ¶5).
This is not found persuasive. The NAAIC guidelines do not clarify if a variety must have the specific percentages recited in Tables 1-17 or if a variety only need to have the broad ranges encompassed by “high resistance”, “resistance”, very winterhardy”, etc. The guidelines do not clarify if the population must have R413A114’s undisclosed phenotypic traits and at what percentages they must be at.
Part B
Applicant urges that in Ex Parte C the Board held that, based on the description provided and deposit, applicants successfully taught the claimed variety of soybean (response pg 12).
This is not found persuasive
35 USC 112 requires that the specification have a written description of the invention:
35 U.S.C. 112 Specification.
(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. (emphasis added)
The statute is clear that the specification shall contain a written description of the invention. The question becomes what is an adequate written description for a new plant variety. What is adequate is a question of fact for the fact finder, i.e., the examiner or Office.
The references cited in the rejection are evidence regarding that question of fact regarding what is considered when describing plants. They are not cited for legal analysis. The references cited, including USDA and UPOV, establish that in the plant variety art, a breeding history is part of the description of a plant variety.
Applicant has not provided evidence saying that in the plant variety art the breeding history is not considered art of the description of a plant variety. Applicant has not rebutted the evidence provided in the rejection.
It is noted that the Declaration states “the distinctness of an alfalfa variety is maintained by determining which plants are the founder parent plants (¶4) and distinguishes the claimed population from the claimed one partly on the basis of having different founder parent plants. Thus, Declarant considers the parents of alfalfa variety R413A114 part of its description. The specification does not describe these parents.
Claims 1-2, 6-16, and 22-25 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 7 July 2025, as applied to claims 1-27. Applicant’s arguments filed 7 October 2025 have been fully considered but they are not persuasive. Part A of the rejection mailed 7 July 2025 is unchanged. Parts B and C of the rejection mailed 7 July 2025 were overcome by Applicant’s amendment of the claims, and removed from the rejection as a whole. Part D is new.
A. The deposit is does not meet the requirements of 37 CFR 1.801 through 1.809.
The claims all require seed of alfalfa variety R413A114.
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 has deposited seeds for alfalfa variety R413A114 at the NCMA, and that the deposit has been accepted under the Budapest Treaty (¶150). However, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made and accepted under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
D. No one packet of seeds in the deposit is enabling for the claimed population.
The standard seed deposit is for 625 seeds (MPEP 2403.02), split into 25 packets of 25 seeds. A single seed packet will not enable a population of seeds of alfalfa variety R413A114, wherein representative seed of said alfalfa variety have been deposited under NCMA Accession No. 202111026 and wherein a population of plants produced from the population of seeds has all of the physiological and morphological characteristics of said alfalfa variety R413A114.
Each seed packet must have a sufficient number of seeds so that when the population of plants produced from the seeds has all of the physiological and morphological characteristics of said alfalfa variety R413A114. If 625 seeds are required for that population, then a requestor asking for that population would wipe out Applicant’s entire deposit, presuming the depository would even release all the seeds in the deposit.
Thus, Applicant is required to deposit 25 seed packs each with a sufficient number of seeds to enable the claimed population.
Response to Arguments
Applicant and the Declaration repeat arguments above that apply to parts B and C of the previous rejection (response pg 13-15; Declaration ¶3, 8).
This is not found persuasive. Applicant has not provided an affirmative statement that all restrictions upon availability to the public will be irrevocably removed upon granting of a patent. While the entire deposit might be sufficient to enable the claimed population, the number of seeds in each single seed packet will not do so.
Parts B and C of the previous rejection were overcome by Applicant’s amendment to claim a population.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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 1-2, 6-16, and 22-25 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al (2020, US Patent No. 10,736,297).
McCaslin et al teaches alfalfa variety R411A106. Both R411A106 and the instant population have yields that are higher than check variety 54R02, are very winterhardy, have fall dormancy ratings similar to FD4, have event J-101, have high resistance to anthracnose (Race 1), bacterial wilt, Fusarium wilt, Verticillium wilt, Phytophthora root rot, and Aphanomyces root rot (Race 1), resistance to spotted alfalfa aphid (column 4, lines 1-47; Tables 1-16). McCaslin et al are silent regarding the resistance of R410M324 to stem nematode (Race 2).
The population of R411A106 plants has a slightly different proportions of purple, cream, yellow, variegated and white flowers and slightly different resistance to pea aphid. However, the proportions of these traits can change based on which population subset examined.
Thus, R411A106 appears to be identical to the instantly claimed R413A114 population.
The deposit of seeds (claim 1) would be a population of R411A106 seeds.
Bulking R411A106 to form breeder seeds (column 4, lines 19-20) is a method comprising crossing a population of R411A106 plants with itself and harvesting seed, and the seed produced is first generation progeny seed, where the population of plants grown from the seed have all the morphological and physiological characteristics of R411A106, and thus R413A114. Planting the population to produce that seed forms a composition of the seed in soil.
McCaslin et al teach vegetatively propagating R411A106 by collecting tissues the population of plants, cultivating the tissue to form shoots, rooting the shoots to obtain plantlets, and growing plants from the plantlets (column 25, lines 9-19).
McCaslin et al teach introducing a transgene into R411A106 to produce R411A106 with the transgene and otherwise all the morphological and physiological characteristics of R411A106 (column 16, line 6, to column 17, line 30). The transgenes include those that confer male sterility, herbicide tolerance, insect resistance, pest resistance, disease resistance, improved digestibility, improved energy content, improved forage yield, improved seed yield, improved winterhardiness, improved nitrogen fixation, modified fatty acid metabolism, abiotic stress resistance, flowering time, altered seed amino acid composition, and modified carbohydrate metabolism (column 18, line 52, to column 24, line 18). McCaslin et al also teach crossing the transformed plants to produce progeny plants and applying selection to the progeny population for the transgene (column 14, lines 52-65; column 16, lines 4-6).
McCaslin et al teach intercrossing crossing R411A106 with another alfalfa variety (column 10, lines 40-48). McCaslin et al teach producing sprouts, forage, hay, greenchop and silage from the plants (column 3, lines 31-42).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
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.
Claims 1-2, 6-16, and 22-25 are rejected under 35 U.S.C. 101 as claiming the same invention as that of or, in the alternative on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,736,297).
‘297 claims alfalfa variety R411A106. Both R411A106 and the instant population have yields that are higher than check variety 54R02, are very winterhardy, have fall dormancy ratings similar to FD4, have event J-101, have high resistance to anthracnose (Race 1), bacterial wilt, Fusarium wilt, Verticillium wilt, Phytophthora root rot, and Aphanomyces root rot (Race 1), resistance to spotted alfalfa aphid (column 4, lines 1-47; Tables 1-16). McCaslin et al are silent regarding the resistance of R410M324 to stem nematode (Race 2).
The population of R411A106 plants has a slightly different proportions of purple, cream, yellow, variegated and white flowers and slightly different resistance to pea aphid. However, the proportions of these traits can change based on which population subset examined.
Thus, R411A106 appears to be identical to the instantly claimed R413A114 population.
The deposit of seeds (claim 1) would be a population of R411A106 seeds and plants grown from the seeds would be a population of R413A114 plants.
‘297 claims a composition comprising seed of R411A106 in soil or a synthetic cultivation medium (claims 6-7). It would be obvious for that composition to comprise a population of seed of R411A106. As R411A106 is a mixture of plants and seeds, one of ordinary skill in the art would plant that population of seeds in soil to produce more plants.
‘297 claims crossing a plant of R411A106 with itself or another alfalfa plant (claims 8-9) and progeny seed and plants produced from a cross of R411A106 with itself (claims 10-11). It would be obvious to one of ordinary skill in the art to do that crossing with a population of plants as such crossing is routinely done in fields planted with populations of alfalfa plants.
‘297 claims vegetatively propagating a R411A106 plant by collecting tissues the plant, cultivating the tissue to form shoots, rooting the shoots to obtain plantlets, and growing a plant from the plantlets (claims 12-13). It would be obvious to one of ordinary skill in the art to do that with a population of R411A106 plants to maintain the entire genetic variation within R411A106.
‘297 claims introducing a transgene into a R411A106 plant, including where the transgene confers male sterility, herbicide tolerance, insect resistance, pest resistance, disease resistance, improved digestibility, improved energy content, improved forage yield, improved seed yield, improved winterhardiness, improved nitrogen fixation, modified fatty acid metabolism, abiotic stress resistance, flowering time, altered seed amino acid composition, or modified carbohydrate metabolism (claims 14-17). It would be obvious to one of ordinary skill in the art to do that with a population of R411A106 plants so that the entire genetic variation within R411A106 has the transgene.
‘297 claims crossing transformed R411A106 plant with a population of alfalfa plants to produce a population of progeny plants where at least one progeny plant has the transgene and selecting progeny plants with the transgene (claims 22-23). It would be obvious to one of ordinary skill in the art to do that with a population of transformed R411A106 plants so that more of the progeny plants have the transgene.
‘297 claims combining a R411A106 seed with seed of a second alfalfa variety. It would be obvious to one of ordinary skill in the art to do that with a population R411A106 seeds so that an entire filed could be planted.
‘297 claims producing sprouts, forage, hay, greenchop or silage from a R411A106 plant (claims 25-27). It would be obvious to one of ordinary skill in the art to do that with a population R411A106 plants so that more sprouts, forage, hay, greenchop or silage could be produced.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
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/Anne Kubelik/Primary Examiner, Art Unit 1662