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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/29/2025 has been entered.
Claims 1-2, 6-16 and 22-25 are pending and examined herein on the merits.
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.
Applicant’s arguments when taken together with the claim amendments have overcome the rejection of record regarding indefiniteness.
Claim Rejections - 35 USC § 112
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.
Claims 1-2, 6-16 and 22-25 remain rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
The claims are directed to populations of alfalfa variety C0415C3364 and seeds or plants produced by methods of breeding said variety as well as methods for introducing locus conversions into said variety.
As noted above, each individual plant will not possess all of the traits or genes that are disclosed for the variety, but requires rather a population to exhibit said traits. However, it is unknown how large the population would need to be to exhibit all of the traits. This complicates the scope of the claims since the claims require crossing individual plants, growing individual plants and producing individual plants. Progeny of such seeds may or may not resemble the instantly claimed traits whether generating a population or not since even further recombination would be expected as well as outcrossing breeding. Furthermore, the breeding history has not been provided with the specification such that an adequate written description of even a population is described such that one of skill in the art would recognize Applicant to be in possession of the claimed invention.
Response to Arguments
Applicant's arguments filed 08/29/2025 have been fully considered but they are not persuasive.
Applicant’s urge that industry standards define the traits and determine whether or not a population would be considered to possess said traits and that the assertion that plants of a population do not possess a defined set of characteristics is not supported.
This is not persuasive because the size of the populations is neither specified in the claims nor discussed or contemplated in the specification. A population can be two to more plants, but 2 plants would not be representative of the characteristics of the variety as discussed above. Although it may be possible that a deposit of 625 seeds would encompass enough plants to obtain all said characteristics, without a defined number, it is not clear that any given population of any size would be able to be readily determined to be encompassed by the claims as currently written.
Claim Rejections - 35 USC § 112
Claims 1-2, 6-16 and 22-25 remain rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
There is a high degree of indefiniteness regarding what is required for a particular seed or plant to be a member of the instantly claimed alfalfa variety; however, one interpretation is that a plant of this variety must have all of the characteristics disclosed in paragraph 18:
The Applicant has deposited seeds of the instantly claimed variety; however, within a population of plants grown from these seeds the vast majority, if not all, of the plants will not have all of the resistances disclosed for the instant variety. Therefore, one of skill in the art would be left to grow multitudes of seeds and screen for any individual plant that possesses these traits, if there is even one such plant to be found. Screening large numbers of plants in the hopes of finding even one that actually possesses all of the resistances disclosed for the instant variety with no guarantee that one even exists amounts to undue experimentation.
Furthermore, if one of skill in the art were to request seeds from NCMA Accession No. 202111024, 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 C0415C3364”.
Because the deposited seeds are not inbred, but rather a heterogeneous mixture of autotetraploid seeds that have a high degree of heterozygosity, growing any given seed of the deposit and allowing it to self-pollinate will not result in progeny that are the same as the parent plant.
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.
Claims 10 and 11 are directed to a seed and a plant of a first generation progeny alfalfa produced by selfing a plant of variety C0415C3364, wherein the first generation progeny seed and plant have all of the physiological and morphological characteristics of a seed and plant of alfalfa variety C0415C3364.
As discussed above in the indefiniteness rejection, it is unclear what “all of the physiological and morphological characteristics of variety C0415C3364” are. However, if this requirement means that these plants must have all of the resistances listed in paragraph 18, then this is not enabled for the reasons already stated, above.
Applicants teach that alfalfa variety C0415C3364 is a synthetic variety from intercrossing of 144 different parental lines. This indicates that alfalfa variety C0415SN223 is a complex synthetic variety rather than a true-breeding inbred or an F1 hybrid. It is not possible to perform the backcross method using a heterozygous plant as the recurrent parent plant because the genetics of the heterozygous plant are not stable and uniform. It is also not possible to arrive at a progeny plant having all of the physiological and
Applicants do not teach that variety C0415C3364 is a true-breeding inbred variety.
For example, the state-of-the-art shows that the goal of backcrossing is to recover the genome of the recurrent parent see, for example, Chukwu et al. (Plants (2020) Vol.9; pp. 1-15)). Chukwu et al teach that the percentage of the parent genome recovery (RPGR) using markers to assist with selection after backcrossing was about 95%, and this is only possible if the recurrent parent plant has stable and uniform genetics.
Given the lack of guidance in the instant specification, undue trial and error experimentation would be required for one of skill in the art to use the backcross method with a hybrid recurrent parent plant and be able to recover the genetics and characteristics of the hybrid parent plant.
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.
Response to Arguments
Applicant's arguments filed 08/29/2025 have been fully considered but they are not persuasive.
Applicant’s urge that the claims are enabled by the deposit and that characteristics could be determined and that the industry standard is known for determining the size of the population required to maintain the instant traits.
This is not persuasive because the size of the populations is neither specified in the claims nor discussed or contemplated in the specification. A population can be two to more plants, but 2 plants would not be representative of the characteristics of the variety as discussed above. Although Applicant’s take issue with this broad interpretation citing an industry standard, it is noted that no such standard is described in the specification such that one of ordinary skill in the art would be able to determine if any given population would in fact, have the traits required.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663