DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amendments
The amendments received on Aug. 4, 2025, have been entered. Claims 3-5, 17-21, 26, and 27 have been canceled. Claims 1, 2, 6-16, and 22-25 are pending and are examined in this Office Action.
Objections and Rejections That Are Withdrawn
The objection to the specification is withdrawn in light of Applicant’s amendments to the specification.
All objections and rejections of claims 3-5, 17-21, 26, and 27 are moot in light of Applicant’s cancelation of these claims.
The objections to claims 8 and 16 are withdrawn in light of Applicant’s amendments to the claims.
All Art Rejection and Double Patenting Rejections are withdrawn in light of the Ma Declaration (part #9) and Applicant’s arguments expressly stating that the statistical distribution of alleles and phenotypes distinguishes the prior art populations over the instantly claimed populations (Resp 13-16).
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
Claims 1 and 9 are objected to because each of these claims recites “NCMA Accession No. 202210030” but this accession does not conform to 37 CFR 1.801. 37 CFR 1.801 states: “For the purposes of these regulations pertaining to the deposit of biological material for purposes of patents for inventions under 35 U.S.C. 101, the term biological material shall include material that is capable of self-replication either directly or indirectly.” (emphasis added). In this case, the deposited seeds are not capable of self-replication because more than 25 seeds are needed to reproduce a population of alfalfa variety RRL1014T022 that retains the same statistical distribution of characteristic traits and alleles, and the seeds are deposited in packets of 25 seeds (NCMA Patent Deposit webpage; pp. 1-5).
Appropriate correction is requested.
Background on the Technology
After reading up on the state of the art for alfalfa breeding, the Examiner believes that alfalfa breeding is quite different when compared to more common diploid plants that are either inbreds or F1 hybrids produced by crossing to inbreds. In order to properly understand the claimed invention, the Examiner sets forth the following findings of fact:
FF1: Alfalfa is naturally crosspollinated by bees and “tolerates comparatively little inbreeding” (Rumbaugh, M. D. “Breeding and Quantitative Genetics” Chapter 25 in Alfalfa and Alfalfa Improvement (1988) Eds. Hanson, Barnes, and Hill; American Society of Agronomy, Inc. Crop Science Society of America, Inc. Soil Science Society of America Inc.; pp. 777-808; page 777).
FF2: Alfalfa has 8 chromosomes and all cultivars are autotetraploids, meaning four copies of each of the eight chromosomes that will readily recombine with one another via cross-over events during sexual propagation, resulting in complex inheritance for economic traits (Id.).
FF3: For decades, breeders have stressed the development of cultivars with multiple pest resistance incorporated into genetically broad-based synthetics from which commercial seed is produced under limited generation schemes (Id. 778).
FF4: There are multiple different definitions for “synthetic variety” known in the art, and the definition that most closely resembles the breeding history described in the instant specification is attributed to Wood as follows: “Wood defined a synthetic cultivar as an advanced generation of an open-pollinated population composed of a group of selected inbreds, clones, or hybrids.” (Id. 780).
FF5: Synthetic cultivars formed from 100 or more clones are expected to be more stable during seed multiplication than narrow based synthetics (Id. 781).
FF6: Most genes for resistance are dominant (Id. 782).
FF7: When crossing plants with two favorable dominant genes at different loci, less than half will inherit both of the dominant genes and 10% will not have either dominant gene (Id.).
FF8: The National Alfalfa and Forage Alliance (NAFA) published ratings for alfalfa varieties that demonstrate a variety that is designated with “high resistance” is only required to have resistance in greater than 50% of the plants, “resistance” means 31-50% of the plants in the population are resistant, and “moderate resistance” means 15-30% of the plants are resistant (Alfalfa Variety Ratings 2020 (2020) The National Alfalfa and Forage Alliance; pp. 1-8).
FF9: Self-pollination can cause issues because of plants that have self-incompatibility which reduces the seed set and can cause inbreeding depression, and inbreeding has a catastrophic effect on alfalfa (Rumbaugh, 786 and 803).
FF10: The phenotypic effects of traits in which having different alleles at the same locus (heterozygosity) causes interactions that affect the phenotype is very complicated and hard to predict (Id. 795-8).
FF11: Populations of alfalfa are rarely, if ever, in random mating equilibrium (RME) (Id. 803).
FF12: Selfing a population for only two or three generations leads to near extinction of the population due to loss of vigor and increased sterility and is associated with changes in the performance of synthetic varieties over generations (Id. 804-5).
FF13: Alfalfa seed production fields produce a higher level of heterozygosity than what would be predicted based on the Hardy-Weinberg equilibrium with an excess of heterozygotes in both the parents and the progeny (Mabin et al. (2021) Frontiers in Plant Science; Vol. 12; pp. 1- 15; page 11)
FF14: In the response to the 105 request that was received on Feb. 26, 2024, Applicant verified that none of the traits that were selected for are present in all of the plants within the population, rather the percentages are consistent with the NAAIC guidelines for “high resistance” and “resistance” (Spec 6 ¶ 20, 105 response). NOTE: because the resistances are conferred by single dominant genes, a resistant plant might only have one copy of the resistance gene with the other three chromosomes lacking any resistance gene.
These findings of fact demonstrate that a “synthetic variety” is defined and characterized by the distribution and frequency of characteristics and genes throughout the entire population rather than being defined and/or characterized by any attributes of an individual plant or seed.
Declaration of Xuefeng Ma under 37 C.F.R. § 1.132
The Ma Declaration states that “the sample of at least 625 seeds deposited with the NCMA is more than sufficient to both produce the claimed populations of plants as well as distinguish the claimed populations from any other known alfalfa varieties (Ma Declaration part #3). The Examiner agrees that the “at least 625 seeds” deposited with the NCMA are sufficient to provide defined metes and bounds, adequate written description, and enablement for a population of at least 625 plants of alfalfa variety RRL1014T022. The Examiner disagrees that the “claimed” population is large enough to be adequately defined, described, or enabled, because the claimed population could include as few as 2 plants. The Examiner disagrees that a packet of seeds with only 25 seeds in it is sufficient.
The Ma Declaration states that synthetic populations maintain the allele and genotype frequencies over generations in the absence of disturbance by outside factors which is consistent with the Hardy-Weinberg principle (Ma Declaration part #4). The Examiner agrees, so long as the required minimum number of plants are grown together for interbreeding with no outside factors influencing the relative success of some alleles/genotypes over others.
The Ma Declaration states that the instant variety was shown to be stable between the Syn1, Syn2, and Syn3 generations which maintained the allele frequencies (Ma Declaration part #5). The Examiner agrees, however, the specification and the declaration do not provide the number of plants grown for the Syn1, Syn2, or Syn3 generations.
The Ma Declaration states that the sample of at least 625 seeds deposited with the NCMA is more than sufficient to produce the claimed populations and is therefore representative of a population of plants of alfalfa variety RRL1014T022 (Ma Declaration part #6). The Examiner agrees, however, the seed packets that are provided to a practitioner who requests seeds from the NCMA will contain only 25 seeds, and the claimed population is only required to comprise at least 2 plants. This statement would only be germane to patentability of the seed packets comprised at least 625 seeds and the claims required at least 625 plants.
The Ma Declaration states that industry-standard testing guidelines were used that specify the required number of plants and replicates for each of the various trials evaluating for pest resistance and agronomic traits (Ma Declaration part #7). The specification stated this on page 6, and the Examiner does not disagree with this.
The Ma Declaration asserts that the “at least 625 seeds” that were deposited is sufficient to be able to make and use the claimed population (Ma Declaration part #8). The Examiner agrees, however, the seed packets that are provided to a practitioner who requests seeds from the NCMA will contain only 25 seeds, and the claimed population is only required to comprise at least 2 plants. This statement would only be germane to patentability of the seed packets comprised at least 625 seeds and the claims required at least 625 plants.
The Ma Declaration provides differences between the prior art varieties and the instant variety (Ma Declaration part #9). The art rejections were each based on the claims being directed to an individual plant.
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.
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 these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. This rejection was modified to address the amendments to the claims. Applicant’s arguments in the response received on Aug. 4, 2025, have been fully considered but were not found to be persuasive.
Claim 1 is drawn to a population of seeds of alfalfa variety RRL1014T022, wherein representative seed of said alfalfa variety have been deposited under NCMA Accession No. 202210030; and wherein a population of plants produced from the population of seeds has all of the physiological and morphological characteristics of said alfalfa variety.
The metes and bounds of the claim are indefinite because it is unclear how a packet of 25 seeds is “representative” of this variety. The NCMA provides packets of 25 seeds for patent deposits (NCMA Patent Deposit webpage; pp. 1-5). The instant synthetic variety encompasses a diverse and very heterogeneous population of alfalfa plants resulting from crosses of 90 separate parent plants (e.g., see FF14 and FF15). A packet of 25 seeds is unable to provide the statistical distribution of allele and traits that is required for the instant variety, so it is unclear how this packet can be “representative”.
In the response received on Aug. 4, 2025, Applicant did not provide any arguments directed to the packet of 25 seeds, specifically. Their arguments focused on their data tables and on the deposit of “at least 625 seeds” (Resp 10). These arguments are not persuasive, however, because the claims do not require a population of at least 625, and because the NCMA provides the seeds in packets of 25, therefore, the packet of 25 is what would need to be relied upon for being representative.
Inadequate Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 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 claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection was modified to address the amendments to the claims. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on Aug. 4, 2025, have been fully considered but were not found to be persuasive.
The claims are drawn to a population of seeds of alfalfa variety RRL1014T022, wherein representative seed of said alfalfa variety have been deposited under NCMA Accession No. 202210030; and wherein a population of plants produced from the population of seeds has all of the physiological and morphological characteristics of said alfalfa variety, and to populations of seeds or plants that are progeny of alfalfa variety RRL1014T022, and methods of introducing locus conversions into said variety. The population has no minimum size, and therefore, it is inclusive of a group as small as two of the instant variety.
The variety has been described by characteristics of a large enough group of plants to produce statistics on the distribution of different characteristics. The claims have no minimum number for the claimed population, therefore, the claims are inclusive of a population as small as two plants.
Applicant has not described any populations of two plants that have all of the physiological and morphological characteristics of the instant variety. Specifically, Applicant has not described any small number populations of plants that comprise the statistical distribution of flower colors or resistance alleles that are required to be the instant variety. Furthermore, the arguments against the art rejections and double patenting rejections emphasize the differences in statistical distributions. These differences cannot be observed or measured without a sufficiently large population of plants.
For at least these reasons, the claims are not adequately described across the full breadth of the claims.
Applicant’s arguments are focused on the “at least 625 seeds” deposited with the NCMA (Resp. 11), and this is not persuasive because the claims do not require a population of “at least 625”.
Lack of Enablement
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. This rejection was modified to address the amendments to the claims. Applicant’s arguments in the response received on Aug. 4, 2025, have been fully considered but were not found to be persuasive.
The claims are drawn to a population of seeds of alfalfa variety RRL1014T022, wherein representative seed of said alfalfa variety have been deposited under NCMA Accession No. 202210030; and wherein a population of plants produced from the population of seeds has all of the physiological and morphological characteristics of said alfalfa variety, and to populations of seeds or plants that are progeny of alfalfa variety RRL1014T022, and methods of introducing locus conversions into said variety.
The Applicant has deposited seeds of variety RRL1014T022; however, if one of skill in the art were to request seeds from NCMA Accession No. 202210030, then they would receive a package of 25 seeds. There is no possibility that these 25 seeds would grow into a population having the same statistical distribution of alleles as the population that was designated “variety RRL1014T022”. The previous art rejections and double patenting rejections were withdrawn based upon the Ma Declaration (part #9) and Applicant’s arguments (Resp 13-16) that require the instant population to have the same statistical distribution of alleles and phenotypes for distinguishing the instantly claimed population from the prior art populations.
Therefore, the deposited seeds are not enabling for the instant invention by either providing an individual plant with all of the disclosed resistances or by providing a population of plants with the same statistical distribution of alleles. The Ma Declaration states that 625 sees is “more than sufficient” to be enabling, therefore if Applicant were to deposit 25 seed packets which each comprise at least 625 seeds, then Applicant would be enabled for a population of at least 625 plants and seeds that together make up a population of the instant invention.
Therefore, given the breadth of the claims; the lack of guidance and working examples; the unpredictability in the art; and the state-of-the-art as discussed above, undue experimentation would be required to make the claimed invention, and therefore, the invention is not enabled throughout the broad scope of the claims.
Applicant’s arguments repeat assertions in the Ma Declaration which have been addressed, above, and Applicant’s arguments focused on the “at least 625 seeds” deposited with the NCMA (Resp. 11-13), and this is not persuasive because the claims do not require a population of “at least 625”.
Summary
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.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached on M-F 9:00 - 5:30 EST.
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CATHY KINGDON
Primary Examiner
Art Unit 1662
/CATHY KINGDON/Primary Examiner, Art Unit 1662