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 .
Status of Claims
Claims 1-21 are pending.
Claims 1-21 are examined in this Office action.
Duty of Disclosure
Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered pertinent to patentability includes: 1) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 2) if backcrossing was used in the breeding history, then the recurrent parent should be disclosed along with any publications or public disclosures of the recurrent parent, and what events/loci/transgenes/traits were donated from the non-recurrent parent along with any publications or public disclosures of the events/loci/transgenes/traits or of the donor parent line itself, 3) if the parental varieties were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/transgenes/traits were donated from the non-recurrent parent, 4) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants should be disclosed. All of this information is pertinent for patentability. If, for example, one of the parent plants is published but with a different name/designation, then the publication should be included in the IDS along with an explanation that the different name/designation is a synonym and how this plant is related to the instantly claimed plant.
Applicant has disclosed that arugula variety CN SROC 2520 is the result of an open pollination using variety CN SROC 2505 as the starting material beginning in 2013 (instant Specification, page 19, lines 15-16). As such, Applicant must disclose if arugula variety CN SROC 2505 was ever publicly available, or is referenced by any other name(s) besides CN SROC 2505.
Information Disclosure Statement
Initialed and dated copy of Applicant’s information disclosure statement (IDS) filed on
03/04/2024 is attached to the instant Office Action. The submission is in compliance with the provisions
of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the Specification has missing
seed deposit information in the “DEPOSIT” paragraph (page 7, line 10) (as well as, page 2, line 6; page 3, line 11; page 4, line 5; page 5, line 8; page 6, line 22; page 34, lines 20 and 25).
Appropriate correction is required.
Claim Objections
Claims 8, 11, 13, 15, 17-19, and 21 are objected to because of the following informalities: for clarity, it is suggested to insert ---, the method--- prior to the word “comprising” in each of the recited claims.
Appropriate correction is required.
Claim Interpretation
For claim 15(e), phrases that are “optional” within the claim are non-limiting.
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.
Indefiniteness
Claims 1-21 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.
Claims 1-21 are indefinite for not including the NCIMB accession number. The claims are also indefinite in the recitation of CN SROC 2520 because the name does not clearly identify the claimed arugula variety, seed and plant and does not set forth the metes and bounds of the claimed invention. Since the name of CN SROC 2520 is not known in the art, the use of said name does not carry art recognized limitation as to the specific characteristics or essential characteristics that are associated with denomination. In addition, the name appears to be arbitrarily assigned and the specific characteristics associated therewith could be modified, as there is no written description of the arugula plant that encompasses all of its traits. To overcome this aspect of the indefiniteness rejection, Applicant should amend Claims 1, 13, 15, 16, and 21 to recite, for example, the complete accession number for arugula variety CN SROC 2520.
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.
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.
Written Description
Claim 21 is 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.
The claim is directed to a method of determining the genotype of a plant of arugula variety CN SROC 2520. The method comprises the step of detecting a plurality of polymorphisms between the two nucleic acid samples, wherein the plurality of polymorphisms is indicative of arugula variety ‘CN SROC 2520’ and/or give rise to the expression of any one or more, or all, of the morphological and physiological characteristics of arugula variety ‘CN SROC 2520’.
The instant Specification does not describe how to follow the genetics of the characteristics of arugula variety CN SROC 2520. The claim requires “detecting a plurality of polymorphisms”, but the instant Specification does not disclose any polymorphisms that are associated with the novel traits of arugula variety CN SROC 2520. The instant Specification does not provide sufficient guidance for the number and identity of the broadly claimed genus of polymorphisms which are causally related to the novel traits of arugula variety CN SROC 2520.
Accordingly, the claims are drawn to an extremely large genus of polymorphisms allegedly associated with the claimed phenotype of the novel traits of arugula variety CN SROC 2520. However, the Specification fails to provide an adequate written description to support the breadth of the claims.
Incomplete Breeding History
Claims 1-21 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.
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 arugula variety (CN SROC 2520). So, the examiner will evaluate what is an adequate written description for a new arugula 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 on pages 20-21. However, there is an incomplete accompanying breeding history in the specification. Because the specification lacks a complete 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 included some breeding history for arugula variety CN SROC 2520 in the Specification. This disclosure is insufficient because it does not address all the issues set forth above. Applicant has disclosed that arugula variety CN SROC 2520 is the result of an open pollination using variety CN SROC 2505 as the starting material beginning in 2013 (instant Specification, page 19, lines 15-16). Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete. Was CN SROC 2505 grown in a field by itself and self-pollinated? Surrounded by other plants of the same variety? Surrounded by plants of a different variety? 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.
Enablement
Claims 1-21 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.
The invention appears to employ novel arugula plants. Since the plant 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. If the plant is not so obtainable or available, a deposit of seed thereof may satisfy the requirements of 35 U.S.C. 112. 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. It is noted that Applicant intends to deposit seed of arugula variety CN SROC 2520 (pg. 7, lines 10-17).
If the deposit of these seeds is made under the terms of the Budapest Treaty, then a statement, an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the seeds have been deposited and accepted, and 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. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been 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 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, an affidavit or declaration, or by someone empowered to make the same, 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 in accordance with 37 CFR 1.808(a)(2):;
(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 effective life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Summary
No claim is allowed. Claims 1-21 appear to be free of the prior art, given the failure of the prior art to teach or suggest an arugula plant having all of the morphological and physiological characteristics of the claimed arugula variety CN SROC 2520, and also having the same parental genetics.
The closest prior art in regard to Claims 1-21 can be found in LANGERAAR (Langeraar, G.A., US Patent No. 12,137,652 B2, issued 11/12/2024) which teaches arugula variety designated Salad Rocket Variety 88-208 RZ, sharing many traits in common (or does not significantly differ) with instant arugula variety CN SROC 2520 including: width of primary lobes, leaf color, intensity of color, and petal color. However, the plants differ in at least: parental genetics, leaf attitude, anthocyanin coloration of veins, and breeding history.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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 at 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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CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663