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 the Claims
Claims 1-20 are pending and are examined in this Office action.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites the limitation "the plant part of the plant of claim 1". Claim 1 does not recite “a plant part”. Therefore, there is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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.
Incomplete Breeding History
Claims 1-20 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.
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 pepper hybrid SVHA0261. So, the examiner will evaluate what is an adequate written description for a new pepper hybrid. 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 an incomplete 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”.
2. 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/pvpo/ application-help/apply, accessed 05/01/2023).
3. 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 Notes 14 and 30).
4. 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.
5. As seen above in Ex Parte C and Ex Parte McGowan, a trait table alone is insufficient to differentiate varieties. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al (2011, Plant Physiol., 155:645-655) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false (p. 645, col. 1). 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, col. 2 and p. 646, col. 1). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar (Großkinsky et al, 2015, J. Exp. Bot., Vol. 66(11):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, as 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 for 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, in this case, all names of both parents, is not known to the public, the public does not have all needed information 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 to provide the complete breeding history used to develop pepper hybrid SVHA0261. 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).
Enablement
Claims 1-20 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 claims all require seeds of pepper hybrid SVHA0261.
Since the seeds 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 pepper hybrid SVHA0261 at the NCMA, and that they have been accepted under the Budapest Treaty (paragraph 0094). Applicant states in paragraph 0094 that “[u]pon issuance of a patent, all restrictions upon the deposits will be removed, and the deposits are 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).
Claim Rejections - 35 USC § 101
Claims 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a
mental process or judicial exception (polymorphism) without significantly more.
Claims 18-20 are rejected under 35 U.S.C. § 101 as directed to an abstract idea without significantly more. Claim 18 is directed to detecting polymorphisms (naturally occurring genetic variations) in nucleic acid samples, which constitutes a law of nature and abstract idea under Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013). While Claim 18 depends on Claim 1, the claim’s explicit inclusion of “or a progeny plant thereof” introduces impermissible generality. The specification defines progeny broadly in paragraph 0084 as any descendent. Consequently, progeny plants are indistinguishable from conventional pepper plants and do not provide a meaningful technical limitation. The core inventive concept—identifying which polymorphisms correspond to the progeny—remains fundamentally a mental classification process or the detection of known natural correlations (markers) with generic pepper plants.
Claims 19-20 compound this deficiency by adding only routine, conventional steps: DNA sequencing, genetic marker analysis, and computer data storage. These techniques are well-established in the art and are explicitly described in the specification as standard methods available to those of ordinary skill (paragraphs 0062-0069). Storing or transmitting results on a computer readable medium does not transform the underlying abstract idea into patent-eligible subject matter, as established in Alice Corp. v. CLS Bank, 573 U.S. 208 (2014). The specification provides no evidence of unexpected technical results, improved performance, or an inventive concept beyond the routine application of conventional genotyping and data handling.
To overcome this rejection, Applicant should consider narrowing Claim 18 to eliminate the “progeny plant” language and limit the method specifically to determining the genotype of the pepper variety of claim 1. This narrowed scope would tie the abstract idea of polymorphism detection to the specific, novel plant cultivar, potentially providing sufficient technical limitation.
Summary
No claim is allowed.
The claims appear to be free of the prior art. The prior art does not teach or suggest a pepper plant comprising all of the physiological and morphological characteristics of the claimed pepper hybrid SVHA0261.
The closest prior art appears to be JUST (Just, B., Patent No.: US 12,520,807; Date of Patent: Jan. 13, 2026), which teaches pepper hybrid SVPH8928. This pepper hybrid shares several characteristics with the instantly claimed pepper hybrid, but differs in at least length of stem and blade width; and they also have different parentage.
The instant variety is not disclosed by the prior art and the prior art does not otherwise render the claimed subject matter obvious.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/ Examiner, Art Unit 1663
/Amjad Abraham/ SPE, Art Unit 1663
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