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 .
Information Disclosure Statement
Initialed and dated copy of Applicant’s information disclosure statements (IDSs) filed on 12/14/2023 (two documents) are attached to the instant Office action. The submissions are in compliance with the provisions of 37 C.F.R. § 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Claims
Claims 1-23 are pending and are examined in this Office action.
Claim Objections
Applicant is advised that should claim 5 be found allowable, claim 8 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). In the instant case, both claims are drawn to a onion plant having all the physiological and morphological characteristics of onion line SVNB5777.
Claim 9 is objected to because of the following informalities: in part (a) it recites “crossing the plant of claim 1 with itself …”, and this is technically inaccurate because in the art one refers to this a “selfing” or “self-pollinating”, a cross is taking pollen from one plant and using it to pollinate a different plant.
Appropriate correction is requested.
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 the second paragraph of 35 U.S.C. § 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Indefiniteness
Claims 1-23 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 pre-AIA 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.
The claims are directed to an onion plant of onion line SVNB5777, a sample of seed of said line having been deposited under NCMA Accession Number 202306105, to methods that utilize such plants, to plants derived from such plants, and to plants having all the physiological and morphological characteristics of the plant.
On page 9 of the specification, the following statement appears: “Onion line SVNB5777, also known as BUN-UH17-4807 and 17-UH-BUN-4807, is an amphidiploid bunching onion variety that produces a plant with a blue green color, compact flowers, a long blanched pseudostem, a long pointed sepal, and yellow anther.” Therefore, it appears that the word “line” and “variety” are being used interchangeably.
It is known in the art that a cultivated “variety” or “cultivar” is required to be able to be reproduced with characteristics that always remain “true” (see Biology Dictionary definition for “cultivar”; attached to this Office action). The characteristics are controlled by homozygous genes for the variety such that the plant can self-fertilize which will produce plants that are also homozygous for the traits, or alternatively, the line is maintained clonally through vegetative propagation. It is clear that the instant onion line is to be propagated via seeds, therefore, in order for the plants to constitute a “line” or a “variety”, the seeds would need to be substantially homozygous such that the line is true breeding. Unfortunately, the parental cross described (cross of Allium cepa with Allium fistulosum; specification, ¶0031) would not result in substantially homozygous seeds, therefore, the instant onions do not appear to constitute a “line”. For this reason, the metes and bounds of the claims are not clear. One of skill in the art would not know if a bunching onion is a member of this “line” or not.
The onion line SVNB5777 is a bunching onion type and is a cross of Allium cepa with Allium fistulosum (specification, ¶0031). Because of the genetic variation in the chromosomal DNA, differences at the DNA level would not be able to be relied upon to distinguish over other interspecific hybrids produced from crossing Allium cepa and Allium fistulosum, therefore, the sample of seed that has been deposited does not help to define the “line” by uniform genetics.
Similarly, the characteristics disclosed in Table 1 (pages 10-12 of the specification) cannot be relied upon because at the bottom of page 12 the specification states: “These are typical values. Values may vary due to environment. Other values that are substantially equivalent are within the scope of the invention.” What are the metes and bounds of “substantially equivalent”? In addition, the numeric values do not provide any standard deviation nor were the growth conditions provided, and it is known in the art that many of these characteristics, such as the sizes that were measured, are influenced by growth conditions.
In the interest of compact prosecution, the claims are nonetheless examined.
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Enablement, Deposit
Claims 1-23 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 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 claims all require seeds of onion line SVNB5777.
Since the seed claimed are essential to the claimed invention, they 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 seed is readily available to the public.
If seed is not so obtainable or available, deposits 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 onion line SVNB5777 at the NCMA (Accession No. 202306105), and that they have been accepted under the Budapest Treaty (¶00105). Applicant states in ¶0093 that “[u]pon issuance of a patent, all restrictions upon the deposit will be removed and the deposit is intended to meet all of the requirements of 37 C.F.R. §§1.801-1.809.” However, 37 CFR § 1.808 requires that a statement be made that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent. It is not clear from this statement in the specification if all restrictions upon availability to the public will be irrevocably removed upon granting of the patent or if all restrictions upon availability to the public will be merely removed upon granting of the patent.
If the deposits of these seeds were made 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.
If the deposits were not made under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
Written Description
Claims 1-23 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to an onion plant of onion line SVNB5777, a sample of seed of said line having been deposited under NCMA Accession No. 202306105, to methods that utilize such plants, to plants derived from such plants, and to plants having all the physiological and morphological characteristics of the plant.
A. The instant specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art
Section 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 a 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 onion variety (SVNB5777). So, the examiner will evaluate what is an adequate written description for a new onion 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 Table 1. 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, at https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023).
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).
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, decided June 15, 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.
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. For example, Haun et al., 2011, Plant Physiology, Vol. 155, pp. 645-655 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., 2015, J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 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 variety. 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 and all other potential names for the claimed variety. If Applicant’s breeding history uses proprietary variety names, Applicant should notate in the specification all other names of the proprietary varieties, especially publicly disclosed or patented variety 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 variety). 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 included some breeding history for variety SVNB5777 in the Specification. This disclosure is insufficient because it does not address all the issues set forth above. Thus, the breeding history for the claimed variety as disclosed in the Specification is incomplete. Moreover, the specification states that the values of the physiological and morphological characteristics of onion line SVNB5777, stated in Table 1, “may vary due to environment” (page 12, footnote of Table 1). Additionally, paragraphs [0013-0014] state that the term “a plant of onion line SVNB5777” includes added heritable traits and any single locus conversions of that line, and a single locus conversion includes one or more site-specific changes to the plant genome, such as, without limitation, one or more nucleotide modifications, deletions, or insertions. A single locus may comprise one or more genes or nucleotides integrated or mutated at a single chromosomal location. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of onion 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 line, including all names for the parents and for the claimed line, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
B. Claim 13 is drawn to an onion plant produced by a method comprising backcrossing a desired trait into a plant of onion line SVNB5777. Claim 15 is drawn to an onion plant produced by a transgene into a plant of onion line SVNB5777.
Claim 13, while requiring via its parent claim that the plant have the desired trait and otherwise all the physiological and morphological characteristics of SVNB5777, places no limits on the number of desired traits in the claimed plant. The claim thus reads on an onion plant with any number of differences in physiological and morphological characteristics and genetics compared to SVNB5777.
Transgenes can be introduced into a plant by any number of crossing steps with any number of other plants; thus the plant claimed in claim 15 has no requirement of having the transgene and otherwise all physiological and morphological characteristics and genetics of SVNB5777.
The specification describes no structural features that distinguish plants of onion line SVNB5777 comprising any number of desired traits or differences in physiological and morphological characteristics and/or genetics from other onion plants.
Hence, Applicant has not, in fact, described the onion plants of claims 13 and 15, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
C. In addition, and as discussed above, onions designated “SVNB5777” appear to encompass a genus of onions that are not homogeneous at the chromosomal level, and the metes and bounds of the characteristics disclosed in Table 1 are not clear. For this reason, the line has not been described in such a way to allow one of skill in the art to know if any particular interspecific hybrids produced from crossing Allium cepa and Allium fistulosum would be infringing or not. See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification.
With regard to claim 15, specifically, this claim is directed to an onion plant produced by a method “comprising” introducing by genetic transformation a transgene conferring a trait into a plant of claim 1. Because the method uses the open language of “comprising” it is inclusive of an unlimited number of additional unrecited method steps and materials, therefore, the plant being claimed in claim 15 could be distally related to an onion of line SVNB5777 and could no longer retain enough DNA or enough characteristics to be recognized as a member of the line, therefore it has not been adequately described.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Summary
Claims 1-23 are deemed to be provisionally free of the prior art, given the failure of the prior art to teach or suggesting an onion plant having all of the morphological and physiological characteristics of the onion line SVNB5777 deposited under NCMA Accession Number 202306105. It should be noted that this statement is based only on a comparison of the morphological and physiological characteristics of the deposit against the prior art. This statement is provisional because Applicant has not provided any information regarding the parental lineage or breeding methodology used to produce the deposited onion variety. Without this information, a meaningful comparison of the genetic and phenotypic basis that would distinguish the deposited onion variety from prior art plants cannot be made. Thus, this statement will remain provisional until the necessary information requested above is received, corrections are made to the description, and a complete search of the prior art can be completed.
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRATISLAV STANKOVIC whose telephone number is (571) 270-0305. The examiner can normally be reached Monday-Friday, 08:00-17:00 h EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRATISLAV STANKOVIC, PhD, JD
Primary Patent Examiner
Art Unit 1663
/BRATISLAV STANKOVIC/Primary Examiner, Art Unit 1663