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 .
DETAILED ACTION
1. Claims 1, 2, 7-10 and 13-22 are pending and are examined in the instant application.
Specification
2. The disclosure is objected to because of the following:
The status of parent Application No. 18/378375 should be updated in paragraph [0001] of the specification.
In paragraph [0086], the Deposit Information does not indicate that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent..
Appropriate correction is required.
Claim Objections
3. Claims 1, 2, 7-10 and 13-22 are objected to because of the following:
In claims 1, 15 and 17, “a sample of seed” should be amended to “a sample of seeds” because more than one seed is deposited.
Dependent claims are included.
Correction is required.
Claim Rejections – 35 USC § 112(a)
4. 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.
5. Claims 1, 2, 7-10 and 13-22 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.
Since the seed of line SVPB3274 is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a reproducible 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. If the deposit of the seed is 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 the seed have been deposited under the Budapest Treaty and that the seed 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 criteria 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;
(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 unviable.
The specification does not indicate that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent. Evidence of an accepted deposit is requested.
6. Claims 1, 2, 7-10 and 13-22 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 “The specification shall contain a written description of the invention” (emphasis added). 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 pepper hybrid (SVPB3274). So, the examiner will evaluate what is an adequate written description for a new pepper hybrid. In reviewing this question of fact, the examiner analyzes how plant varieties are evaluated in the public domain. The review concludes that generally the minimum requirements for an adequate description of a new plant variety are a trait table and genetic information (via a breeding history). In reviewing the specification, Applicant discloses the breeding history in paragraph [0029] and a phenotypic description of hybrid SVPB3274 in Table 1. Applicant further discloses that the claimed hybrid is also known as 15-8T-BLK-3274 [0026]. However, in Applicant’s Transmittal Letter filed in parent Application No. 17/579172 on September 27, 2022, Applicant discloses that the claimed hybrid SVPB3274 is also known as CAYUCOS, which is not disclosed in the specification. Absent the disclosure in the Transmittal Letter, one skilled in the art would not have known that the claimed hybrid is also known as CAYUCOS. Because the Transmittal Letter is not part of the specification, the breeding history disclosed in the specification is considered to be incomplete. Thus, Applicant has not fulfilled the requirement of 35 USC 112(a) to provide an adequate written description in the specification. The Office’s reasonable basis for challenging the adequacy of written description is supported 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 in Ex Parte C and Ex Parte McGowen, a trait table is insufficient to differentiate varieties by itself.
It has been long established that intraline heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite lines 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 line 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 line. (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 complete 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 Applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Importantly, it should be noted that the citations above are not referenced for legal authority. The legal authority relied 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 for the adequate description of a plant variety.
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) further 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).
A complete 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 variations of a variety. 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 yet to be patented. Because the instant specification lacks a complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including all the names of the parents, all the names of the claimed hybrid, and their public availability, are not known to the public, the public could only rely on the limited information provided 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. An adequate written description is essential to preclude the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the Specification.
To overcome this rejection, Applicant must amend the specification/drawing to provide all the names of the parent lines used to develop the instant cultivar and all other names for the claimed names, and their public availability. 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 line). 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 Information Disclosure Statement 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).
Accordingly, Applicant’s disclosure is insufficient because it does not address all the issues set forth above, and the information provided in the Transmittal Letter with regard to the additional name of the claimed hybrid should be set forth in the specification. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Correction and/or clarification is required.
7. Claims 7 and 9 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.
Claims 7 and 9 lack adequate written description because the plant part comprising a cell of the hybrid plant of claim 1 encompasses a progeny seed or embryo cell . A hybrid of variety SVPB3274 has a genome that is heterologous at every locus. When said hybrid is crossed with an unknown parent, it is unpredictable what genetic material its progenies would inherit. The specification does not disclose a representative number of progenies of hybrid variety SVPB3274 to allow one skilled in the art to predict the genetic makeup or physiological and morphological characteristics of the claimed progeny cells. No identifying characteristics are set forth for the progenies. There are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine the genomic structure or morphological and physiological characteristics of the claimed progeny cells, absent further guidance. Accordingly, the claimed plant part and cells lack adequate written description.
Conclusion
8. No claim is allowed. The “cell” is understood by the Office to be a regenerable cell. The claims are free of the prior art. The closest prior art teaches pepper line SBR-8T16-6413 which shares at least 70 morphological and physiological characteristics (+/- 10% std. dev.) with hybrid SVPB3274, including beginning of flowering period, plant height, plant width, branch flexibility, leaf width, leaf length, mature leaf shape, leaf profile in cross section, flowers per leaf axil, calyx lobes, petals, anther color, style length, fruit group, fruit diameter at calyx attachment, flesh thickness, average number of fruits per plant, average fruit weight, fruit shape in longitudinal section, mature fruit color, average depth of pedicel cavity, base shape, apex shape, fruit set, number of locules, calyx aspect, pungency, flavor, seed cavity length and absence of anthocyanin coloration in hypocotyl (Just, B., US Pat. No. 10757904 (A), Table 1). However, at least their maturity days, time of maturity, plant habit, length of the third internode, leaf petiole length, leaf blistering, peduncle attitude, flower diameter, calyx diameter, fruit length, fruit diameter at mid-point, fruit shape in cross section, depth of stalk cavity, average fruit pedicel thickness, depth of interloculary grooves, seed cavity diameter, placenta length, number of seeds per fruit, grams per 1000 seeds and presence of anthocyanin coloration in anther differ.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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