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. The Office acknowledges the receipt of Applicant’s restriction election filed January 9, 2026. Applicant elects Group I, line HJA-FD19-1515, with traverse. Applicant traverses primarily that Group II claims refer back to or incorporate all the limitations of claim 1 (Group I). Applicant’s traversal is unpersuasive because pepper hybrid SVHJ1497 cannot be made from HJA-FD19-1515 alone. Hybrid SVHJ1497 has a set of chromosomes that are not present in line HJA-FD19-1515. Claim 1 is not a generic linking claim, Applicant does not indicate that line HJA-FD19-1515 and hybrid SVHJ1497 are obvious variants of each other, and a search of the prior art for line HJA-FD19-1515 is not co-extensive with that for hybrid SVHJ1497. Accordingly, the restriction is maintained and made FINAL. Claims 1-25 are pending. Claims 4 and 6 are withdrawn. Claims 1-3, 5 and 7-25 are examined to the extent of line HJA-FD19-1515.
Specification
2. The disclosure is objected to because of the following:
The Tile is not descriptive of the claimed invention. It is suggested the title be amended to –PEPPER LINE HJA-FD19-1515--.
The Abstract is not descriptive of the claimed invention. It is suggested recitations of “hybrid SVHJ1497” be deleted.
In paragraph [0093], 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 1-3, 5 and 7-25 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.
In claims 1, 15 and 17, “lines” should be amended to “line”.
In claim 3, it is suggested that “a plant” be amended to “an inbred plant” to distinguish claim 3 from claim 1. For examination purpose, the Office interprets the claimed plant to be an inbred plant.
In claim 5, it is suggested that “a seed” be amended to “an inbred seed” to distinguish claim 2 from claim 5. For examination purpose, the Office interprets the claimed seed to be an inbred seed.
Dependent claims are included.
Correction is required.
Claim Rejections - 35 USC § 112(b)
4. 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.
5. Claims 21 and 23-25 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.
In claim 21, the plant of step (a) cannot be produced from the seed of step (b) because the seed of step (b) is a progeny of the plant of step (a). It is suggested “for producing the plant according to step (a)” be deleted.
Claim 23 is directed to a method of determining the genotype of a progeny plant of the plant of claim 1. However, the recited method step does not address the progeny plant.
Correction and/or clarification is required.
Claim Rejections – 35 USC § 112(a)
6. 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.
7. Claims 1-3, 5 and 7-25 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 HJA-FD19-1515 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.
8. Claims 1-3, 5 and 7-25 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 line (HJA-FD19-1515). So, the examiner will evaluate what is an adequate written description for a new pepper line. In reviewing this question of fact, the examiner analyzes how plant lines/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 Applicant’s specification, there is a phenotypic description of line HJA-FD19-1515 in Table 1. However, there is no accompanying breeding history in the specification for the claimed line. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety, 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 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 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).
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 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 the parents of the claimed variety, 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. 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 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 line names, Applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line 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 variety 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).
In the instant application, the claims indicate that seeds representative of pepper line HJA-FD19-1515 are deposited. The claims are not directed to the deposited seeds or plants grown therefrom. Neither the Specification nor the claims indicates that the claimed seed is genetically identical to the deposited seeds. When two inbred parents are crossed, one skilled in the art would reasonably expect to obtain a population of progeny plants that shares most of the phenotypic characteristics but are not necessarily genetically identical due to naturally-occurring genetic and environmental factors. Thus, the recitation of “HJA-FD19-1515” in the claims is understood by the Office to encompass a genus of seeds/plants that are not are not genotypically identical. Additionally, paragraph [0027] states “A small percentage of variants can occur within commercially acceptable limits for almost any characteristic during the course of repeated multiplication.” The bottom of Table 1 states “These are typical values. Values may vary due to environment. Values that are substantially equivalent are within the scope of the invention.” Further, paragraph [0034] states that an occasional variant trait might arise during backcrossing, introduction of a transgene, or application of a genetic engineering technique. Applicant is claiming a genus of plants that are genotypically and phenotypically different from the deposited material and from the morphological and physiological characteristics disclosed in Table 1. As no other information is disclosed, and many pepper varieties share the same morphological and physiological characteristics, the breeding history is essential to distinguish the claimed genus of plants from other plants. In a separate Transmittal Letter filed May 20, 2025, Applicant discloses that pepper line HJA-FD19-1515 was developed from crossing heterozygous line DON PEDRO believed to be publicly available with substantially homozygous, proprietary line HJA-114-1011X1. The Transmittal Letter further states that “the generation at which the line was finished is unknown or cannot be readily obtained.” Thus, it does not appear that the deposited material is the same as the “finished” line. Absent the disclosure in the Transmittal Letter, one skilled in the art would not have known how the claimed line was produced or the public availability of the parents. However, a Transmittal Letter is not part of the Specification and cannot provide the written description required by the statute to be in the Specification. Thus, the breeding history for the claimed line as disclosed in the Specification is incomplete.
It should be noted that the Patent Owner is not making the genetic sequence (genotype) of the claimed line available, because claims 23-25 would preclude anyone from performing a marker analysis or DNA sequencing to detect a polymorphism without infringing the claimed invention. If a marker analysis cannot be performed, then the written description cannot be satisfied by way of the deposit. Applicant’s claims 23-25 in effect would make the public an infringer to genotype the instant variety as a means to distinguish their plant from the instant line. No genetic marker information is disclosed to distinguish the genus of claimed plants from other plant when Applicant is in the best position to do so. Polymorphisms exist within the genus of plants claimed. Applicant’s failure to provide this information is evidence that it is not practical to do a marker analysis to distinguish Applicant’s genus of claimed plants from others.
Given the facts that Applicant is claiming a genus of seeds/plants that are genotypically and phenotypically different from the deposited material, that many pepper varieties share the same morphological and physiological characteristics as the claimed line, that the Specification is silent with regard to the breeding history of the claimed line, that the deposit cannot be used to provide written description because genotyping the claimed line to distinguish Applicant’s line from others would make the public an infringer, that no polymorphisms are disclosed to distinguish Applicant’s line from others, and that the state of the art as evidenced by the above cited documents indicates that the minimum description for a plant line is the combination of the phenotype and genotype (breeding history) for the claimed line, the Office has determined that the claimed line, as disclosed in the Specification, lacks adequate written description.
Correction is required.
9. Claims 7-9, 11, 12 and 14 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.
In addition to the lack of adequate written description with regard to the breeding history of pepper line HJA-FD19-1515 as set forth above, the claimed invention further lacks adequate written description for the following reasons.
Claims 7 and 9 lack adequate written description because the plant part comprising a cell of the plant of claim 1 encompasses an F2 progeny cell. The plant of claim 1 encompasses an F1 hybrid having one set of chromosomes of line HJA-FD19-1515. The plant part of claim 7 encompasses an F2 embryo and seed of the F1 hybrid plant of claim 1. A hybrid of line HJA-FD19-1515 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 F2 progenies would inherit. The specification does not disclose a representative number of F2 progenies of line HJA-FD19-1515 to allow one skilled in the art to predict the genetic makeup or physiological and morphological characteristics of the claimed F2 progenies. No identifying characteristics are set forth for the F2 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 F2 progenies, absent further guidance. Accordingly, the claimed plant part and cells lack adequate written description.
In claim 8, the claimed pepper plant having all of the physiological and morphological characteristics of the plant of claim 1 lacks adequate written description for the following reasons. Claim 1 is directed to a pepper plant comprising at least one set of chromosomes of pepper line HJA-FD19-1515, which encompasses an F1 progeny plant of line HJA-FD19-1515. An F1 progeny plant of inbred pepper line HJA-FD19-1515 inherently has half of the chromosomes of inbred line HJA-FD19-1515, even though its physiological and morphological characteristics are not disclosed. However, the plant of claim 8 is not required to have half of the chromosomes of line HJA-FD19-1515. In fact, the plant of claim 8 is not required to have line HJA-FD19-1515 as a parent. The plant of claim 8 is only required to have “all the physiological and morphological characteristics of the plant of claim 1.” Because the physiological and morphological characteristics of the plant of claim 1 are undisclosed, the physiological and morphological characteristics of claim 8 are also undisclosed. As the plant of claim 8 is not defined structurally by its genetic makeup or by its physiological and morphological characteristics, the plant of claim 8 lacks adequate written description.
With regard to claims 11 and 12, it is unpredictable what morphological and physiological characteristics the plant utilized in the method of claim 11 and the claimed plant of claim 12 have. Claim 11(a) recites utilizing as a recurrent parent the plant of claim 1. The plant of claim 1 has one set of chromosomes of pepper line HJA-FD19-1515 and encompasses an F1 progeny plant obtained by crossing inbred parent line HJA-FD19-1515 with an undisclosed parent. Because the morphological and physiological characteristics of the plant of claim 1 are not disclosed, a backcross progeny comprising the trait and otherwise comprising the morphological and physiological characteristics of the recurrent parent line used in step (a) is not adequately described. Thus, it is unpredictable what morphological and physiological characteristics the claimed pepper plant of claim 12 produced by the method of claim 11 has in addition to the trait.
With regard to claim 14, the claimed plant further comprising a transgene lacks adequate written description for the following reasons. Initially, it should be noted that the claimed plant encompasses a hybrid of line HJA-FD19-1515. The claims are not directed to an inbred plant of line HJA-FD19-1515 further comprising a transgene and having all the morphological and physiological characteristics of an inbred plant of line HJA-FD19-1515. Thus, prior to producing the claimed plant, an inbred plant of line HJA-FD19-1515 was crossed with an undisclosed plant to produce a hybrid plant having undisclosed morphological and physiological characteristics. Said hybrid plant having undisclosed morphological and physiological characteristics is then transformed or edited by site-specific modification with additional undisclosed plant(s) to introduce the transgene(s). Because it is not known what morphological and physiological characteristics the hybrid plant has prior to the outcrossing(s), the morphological and physiological characteristics of its progenies cannot be predictably determined. Moreover, paragraph [0023] states that the words “a” and “an” denote “one or more,” unless specifically denoted otherwise. Therefore, the claims encompass the incorporation of multiple transgenes. However, because it is not known what morphological and physiological characteristics a hybrid of line HJA-FD19-1515 has prior to the introduction of the transgene(s), additional genomic modifications to said hybrid would not produce a plant that can be adequate described genotypically or phenotypically. Applicant has no working example of a hybrid plant of pepper line HJA-FD19-1515 further comprising one or more transgenes. Thus, the claimed hybrid plant further comprising a transgene lacks adequate written description.
Accordingly, one skilled in the art would not have recognized Applicant was in possession of the claimed invention at the time of filing. See Written Description Guidelines, Revision 1, March 25, 2008, published online at http://www.uspto.gov/web/menu/written/pdf.
Conclusion
10. No claim is allowed. No prior art rejection is made because the Transmittal Letter filed May 20, 2025 discloses the breeding history for the claimed line, wherein the combination of the parents used to produce the claimed line is free of the prior art. The “cell” is understood by the Office to be a regenerable cell. The closest prior art teaches pepper line HJA-FD18-4956V which shares at least 47 morphological and physiological characteristics (+/- 10% std. dev.) with line HJA-FD19-1515, including maturity days from direct seeding until mature red or yellow stage, length of stem from cotyledon to first flower, leaf width, mature leaf shape, profile of leaf in cross section, peduncle attitude, fruit group, fruit attitude/position, fruit diameter at mid-point, average fruit weight, mature fruit color, fruit glossiness, absence of stalk cavity, average fruit pedicel thickness, fruit base shape, fruit apex shape, number of locules, calyx aspect and presence of capsaicin in placenta (Table 1) (Berke, T., US Pub. No. 20230247960 (A), Table 1). However, at least their time of maturity, plant attitude, plant height, length of the third internode, leaf length, fruit length, flesh thickness at mid-point, fruit shape in cross section, average fruit pedicel length and fruit set differ.
11. 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