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 November 18, 2025. Applicant elects Invention I, line PSQ-9Z21-1002. Because no traverse is presented, this election is considered as without traverse. 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 Claims 4 and 6 are withdrawn.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 PSQ-9Z21-1002. The restriction is made FINAL.
Specification
2. The disclosure is objected to because of the following:
The Title and Abstract should be amended to reflect the elected invention, line PSQ-9Z21-1002.
In paragraph [0094], 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 claim 3, it is suggested “a plant” be amended to “an inbred plant” to distinguish the plant of claim 3 from that of claim 1.
In claim 5, it is suggested “a seed” be amended to “an inbred seed” to distinguish the seed of claim 5 from that of claim 2.
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.
Dependent claims are included,
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 PSQ-9Z21-1002 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 tomato line (PSQ-9Z21-1002). So, the examiner will evaluate what is an adequate written description for a new tomato line. 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 Applicant’s specification, there is a phenotypic description of line PSQ-9Z21-1002 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 line, 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 line. 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 line and all other potential names for the claimed line. 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 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 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).
In the instant application, Applicant does not disclose the breeding history for the claimed line in the Specification. In a separate communication filed June 10, 2024, Applicant discloses the breeding history for line PSQ-9Z21-1002. The information provided in the communication should be set forth in the specification, because said communication is not part of the Specification and cannot provide the written description required to be in the Specification. Thus, the breeding history for the claimed line as disclosed in the Specification is incomplete. Moreover, the claims recite that the deposited seeds are representative of line PSQ-9Z21-1002. The claims are not directed to the deposited seeds or plants grown therefrom. Paragraph [0027] states “A small percentage of variants can occur within commercially acceptable limits for almost any characteristic during the course of repeated multiplications.” Table 1 indicates that the disclosed phenotypic traits “are typical values. Values may vary due to environment. Values that are substantially equivalent are within the scope of the invention.” Additionally, paragraph [0035] states “an occasional variant trait … might arise during backcrossing, introduction of a transgene, or application of a genetic engineering technique.” Thus, the claims are directed to a genus of tomato plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Therefore, the question is not whether one skilled in the art can distinguish the claimed plant from other plants, but whether one skilled in the art can distinguish the genus of claimed plants from other plants. The disclosure of the parents, i.e., breeding history, used to produce the claimed genus is an essential component for determining the patentability of the claimed genus. It should be noted that Applicant does not provide marker information to distinguish the claimed genus of plants from other plants 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 plants from one another. Moreover, claims 23-25 would preclude anyone from performing a marker analysis for genotyping the plant. Given these differences, the complete breeding history for producing the claimed line in the Specification is deemed material for patentability.
Correction is required.
9. Claims 7-9, 11, 12 and 14-18 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 tomato line PSQ-9Z21-1002 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 PSQ-9Z21-1002. The plant part of claim 7 encompasses an F2 embryo and seed of the F1 hybrid plant of claim 1. A hybrid of line PSQ-9Z21-1002 has a genome that is heterologous at every locus. When said hybrid is crossed with an undisclosed plant, it is unpredictable what genetic material its F2 progenies would inherit. The specification does not disclose a representative number of F2 progenies of line PSQ-9Z21-1002 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 tomato 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 tomato plant comprising at least one set of chromosomes of tomato line PSQ-9Z21-1002, which encompasses an F1 progeny plant of line PSQ-9Z21-1002. An F1 progeny plant of inbred tomato line PSQ-9Z21-1002 inherently has half of the chromosomes of inbred line PSQ-9Z21-1002, 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 PSQ-9Z21-1002. In fact, the plant of claim 8 is not required to have line PSQ-9Z21-1002 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 tomato line PSQ-9Z21-1002 and encompasses an F1 progeny plant obtained by crossing inbred parent line PSQ-9Z21-1002 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 tomato plant of claim 12 produced by the method of claim 11 has in addition to the introduced trait.
With regard to claims 14-18, the claimed plant further comprising a transgene or a single locus conversion lacks adequate written description for the following reasons. Initially, it should be noted that the claimed plant encompasses a hybrid of line PSQ-9Z21-1002 further comprising a transgene or single locus conversion. The claims are not directed to an inbred plant of line PSQ-9Z21-1002 further comprising a transgene or further comprising a single locus conversion, and otherwise having all the morphological and physiological characteristics of an inbred plant of line PSQ-9Z21-1002. Thus, prior to producing the claimed plants, an inbred plant of line PSQ-9Z21-1002 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 outcrossed with additional undisclosed plant(s) to introduce the transgene(s) or single locus conversion(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 and single locus conversions. Paragraph [0093] states a transgene is a genetic locus comprising a sequence which has been introduced into the genome of a tomato plant by backcrossing or site-specific modification. However, because it is not known what morphological and physiological characteristics a hybrid of line PSQ-9Z21-1002 has prior to the backcrossing or site-specific modification, 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 tomato line PSQ-9Z21-1002 further comprising one or more transgenes. Similarly, with regard to the single locus conversion, paragraph [0008] states that a single locus conversion includes one or more site-specific changes to the plant genome and may comprise one or more genes or nucleotides integrated or mutated at a single chromosomal location. However, because it is not known what morphological and physiological characteristics a hybrid of line PSQ-9Z21-1002 has prior to the incorporation of site-specific changes comprising one or more genes, 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 plant comprising at least a first set of chromosomes of tomato line PSQ-9Z21-1002 further comprising a single locus conversion. Thus, the claimed hybrid plant further comprising a transgene or a single locus conversion 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. 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 tomato line FIS-XJ16-6524 which shares at least 43 morphological and physiological characteristics (+/- 10% std. dev.) with line PSQ-9Z21-1002, including anthocyanin in hypocotyl, mature plant habit, stem branching, type of leaf blade, surface of major leaflets, leafy or “running” inflorescence, anthers, shape of stem end, shape of pistil scar, shape of transverse/cross section, mature fruit weight, core presence, fruit color at maturity, color of flesh at maturity, locular gel color, fruit epidermis color, pericarp thickness, sensitivity to silvering and soluble solids as Brix (Bar, A., US Pub. No. 20210051911, Table 3). However, at least their plant height, number of nodes between first inflorescence, margins of major leaflets, inflorescence type, shape of blossom end, point of detachment of fruit at harvest, length of pedicel, fruit length, fruit diameter, number of locules, time of fruit maturity, ripening patterns, epidermis texture, seeding to 50% flowering days, seeding to once over harvest days, culture, principle use, machine harvest adaptation, pH, titratable acidity and total solids as Brix 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