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 .
Claims 1-27 are pending and examined herein on the merits.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. There are three hyperlinks embedded in the 4 paragraphs following the section “genetically Identifying Alfalfa Varieties”.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities: Claims 1 and 9 both recite “NCMA Accession No. 202110014”. However, 37 CFR 1.801 states “For the purposes of these regulations pertaining to the deposit of biological material for the 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”. In the instant case the deposited seeds are not capable of this self-replication because they are heterozygous autotetraploids, and any progeny will not be the same as the parent grown from the deposited seed. Appropriate correction is required.
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.
Claims 1-27 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is drawn to a seed of alfalfa variety H0416A3114, wherein representative seed of said alfalfa variety has been deposited under NCMA Accession number 202110014.
The metes and bounds of the claim are indefinite because it is unclear how any given seed is “representative” of this variety because this synthetic variety encompasses a diverse and very heterogenous population of alfalfa plant resulting from crosses of multiple parent plants.
Claims 5, 10, 11, 15, 17, 20 and 21 each require “all of the physiological and morphological characteristics of the instantly claimed variety, but it is unclear what characteristics of the variety any particular plant within the variety may actually have. Because each individual plant has only a subset of the traits disclosed for the variety, “a plant” of the variety does not possess a defined set of characteristics. In fact, it is highly probable that there are no seeds at all that possess all of the genes necessary to confer all the characteristics set forth for the variety.
Accordingly the metes and bounds of the claims are indefinite because it is unclear which traits are “representative” of the variety.
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 1-27 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim 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 alfalfa variety H0416A3114 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. 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.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new alfalfa variety (H0416A3114). So, the examiner will evaluate what is an adequate written description for a new alfalfa variety. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in tables 1-15. However, there is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
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” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)).
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, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). 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.
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. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 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 (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
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).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
Moreover, a specification devoid of a complete 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 complete 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 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 and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar 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 should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is 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 cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. 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).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant stated that the instant variety resulted from intercrossing “selected parental plants”. This disclosure is insufficient because it does not address all the issues set forth above, thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed cultivar. The claims are not exclusively directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of alfalfa plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed cultivar, including all names for the parents and for the claimed cultivar, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Claim Rejections - 35 USC § 112
Claims 1-27 are 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. 202110014, 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 H0416A3114”.
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 H0416A3114, wherein the first generation progeny seed and plant have all of the physiological and morphological characteristics of a seed and plant of alfalfa variety H0416A3114.
Claim 17 is directed to a seed that produces an alfalfa plant made by introducing a transgene or a single locus conversion into a plant of the instantly claimed alfalfa variety, wherein the plant comprising the transgene or single locus conversion otherwise comprises all of the physiological and morphological characteristics of the instant variety.
Claim 20 is directed to an alfalfa plant produced by crossing a plant of the variety with a second alfalfa plant comprising a single locus to produce a first generation progeny plant, and selecting a progeny plant that comprises the single locus, wherein the selected progeny plant otherwise comprises all of the physiological and morphological characteristics of the instant variety, and claim 21 is directed to a seed that produces said plant wherein the seed otherwise comprises all of the physiological and morphological characteristics of a seed of the instant variety.
As discussed above in the indefiniteness rejection, it is unclear what “all of the physiological and morphological characteristics of variety h0416a3114” 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.
Claims 5, 11, 15, and 20 are specifically rejected because they are drawn to a progeny plant or seed of alfalfa variety H0416A3114 further comprising a transgene or a locus conversion that has been introduced by backcrossing or genetic transformation into the instant variety.
Applicants teach that alfalfa variety H0416A3114 is a synthetic variety from the intercrossing of “selected” parental lines. This indicates that alfalfa variety H0416A3114 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 H0416A3114 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 5712707058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663