DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-25 are pending.
Claims 1-25 are examined in this Office action.
Specification
The disclosure is objected to because of the following informalities: the Specification has missing seed deposit information throughout (at least at paragraph 0235 on page 63).
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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Indefiniteness
Claims 1-25 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Claims 1-25 are indefinite for including blank spaces. The claims are also indefinite in the recitation of BOTERO because the name does not clearly identify the claimed hybrid tomatillo plant, seed and plant and does not set forth the metes and bounds of the claimed invention. Since the name BOTERO is not known in the art, the use of said name does not carry art recognized limitation as to the specific characteristics or essential characteristics that are associated with denomination. In addition, the name appears to be arbitrarily assigned and the specific characteristics associated therewith could be modified, as there is no written description of the hybrid tomatillo plant that encompasses all of its traits. To overcome this aspect of the indefiniteness rejection, Applicant should amend Claims 1, 11, and 18 to recite, for example, the complete accession number for hybrid tomatillo plant BOTERO.
Claim 2 is rendered indefinite for the recitation of "part thereof" and "cell thereof". No description is provided for the claimed "part thereof" and "cell thereof". Do the "part thereof" and "cell thereof" also have all the physiological and morphological characteristics of hybrid tomatillo designated BOTERO?
Claim 12(c) is rendered indefinite for the recitation of " tomatillo plant ". A tomatillo plant is not a tomatillo fruit.
Claim 18 is rendered indefinite for the recitation of "a single locus conversion". The phrase "a single locus conversion" should be amended to ---the single locus conversion--- for proper antecedence.
In claim 19, it is unclear whether Applicant intends for the single locus conversion to confer all of the recited traits or one (or more) of the recited traits. If Applicant intends the latter, it is suggested "and" be amended to ---or---.
Claim 20 is rendered indefinite for the recitation of "an artificially mutated gene or nucleotide sequence". It is unclear whether "an artificially mutated gene or nucleotide sequence" means (a) an artificially mutated gene or an artificially mutated nucleotide sequence, or (b) an artificially mutated gene or a nucleotide sequence.
Clarification and/or correction is required.
Written Description
Claims 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claimed plant comprising a single locus conversion and otherwise all of the physiological and morphological characteristics of hybrid tomatillo plant BOTERO lacks adequate written description for the following reasons. Paragraph [0026] states that a single locus conversion may introduce multiple genes. Paragraph [0054] states that "a" when referring to "a single locus conversion" encompasses one or more single locus conversions. Paragraph [0060] states that a plant may comprise more than 10 single locus conversions. Since a single locus conversion can introduce multiple genes or alter existing genes, and the recitation of "а single locus conversion" encompasses an unlimited number of single locus conversions, it is highly unpredictable what physiological and morphological characteristics of hybrid tomatillo plant BOTERO are retained, altered or deleted after the introduction of said single locus conversions. Applicant does not disclose a representative number of plants comprising single locus conversions. Moreover, because BOTERO is a hybrid, it is heterologous at every locus. Outcrossing of hybrid tomatillo plant BOTERO with an undisclosed parent, then backcrossing to hybrid tomatillo plant BOTERO, would not regain the morphological and physiological characteristics of BOTERO due to the presence of heterologous dominant and recessive alleles at every locus of the genome of hybrid tomatillo plant BOTERO. Accordingly, the plants of claims 18-21 lack adequate written description.
Incomplete Breeding History
Claims 1-25 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 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 hybrid tomatillo plant (BOTERO). So, the examiner will evaluate what is an adequate written description for a new hybrid tomatillo plant. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen on pages 59-61 (Table 1; paragraph 0229). However, there is an incomplete accompanying breeding history in the specification. Because the specification lacks a complete breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
1. 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/pv po/application-help/apply, downloaded 05/01/2023, (U)).
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 UPOV EDV Explanatory Notes 14 and 30 (V)).
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) (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.
5. As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
Moreover, a specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant included some breeding history for hybrid tomatillo plant BOTERO in the Specification. This disclosure is insufficient because it does not address all the issues set forth above. Applicant has disclosed that hybrid tomatillo plant BOTERO is the result of “crossing two proprietary inbred lines” (Example 1; page 59; paragraph 0224). Thus, the breeding history for the claimed hybrid tomatillo plant BOTERO as disclosed in the Specification is incomplete. The complete breeding history for producing the claimed hybrid tomatillo plant, including all names for the parents and for the claimed hybrid tomatillo plant, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Enablement
Claims 1-25 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 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The invention appears to employ novel hybrid tomatillo plants. Since the plant is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, a deposit of seed thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. It is noted that Applicant intends to deposit seed of hybrid tomatillo plant BOTERO (pg. 63, paragraph 0235).
If the deposit of these seeds is made under the terms of the Budapest Treaty, then a statement, an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the seeds has been deposited and accepted, and will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, an affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR 1.808(a)(2):;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Additionally, Applicant needs to state that the deposit must be self-replicating. According to MPEP 2403.01, “[b]iological material includes material that is capable of self-replication either directly or indirectly. Direct self-replication includes those situations where the biological material reproduces by itself. Representative examples of materials capable of self-replication are defined in the rule. Indirect self-replication is meant to include those situations where the biological material is only capable of replication when another self-replicating biological material is present. Self-replication after insertion in a host is one example of indirect self-replication. Examples of indirect replicating biological materials include viruses, phages, plasmids, symbionts, and replication defective cells. The list of representative examples of each type of replicating material includes viruses to demonstrate that the two lists in the rule are not intended to be mutually exclusive”. Therefore, it is suggested to deposit tissue of the hybrid Tomatillo Botero, or seed of the parents of the hybrid Tomatillo Botero.
Furthermore, claims 17-21 are rejected for the recitation of “a single locus conversion”. Tomatillo Botero is a hybrid, whereby its genome is heterologous at every locus. Thus, one cannot do a locus conversion on a hybrid plant without access to the parents; therefore, hybrid Tomatillo Botero is not enabled for a “a single locus conversion” without knowledge of its parents.
Summary
No claim is allowed.
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
Request for Information under 37 CFR § 1.105
Applicant and the assignee of this application are required under 37 CFR § 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application.
This request is being made for the following reasons:
Applicant is claiming a seed of hybrid tomatillo designated Botero. During a search of the prior art, the following FaceBook post was found appearing to highlight tomatillo Botero (https://www.facebook.com/HMClauseMexico/videos/tomatillo-botero-desde-la-expo-agroalimentaria-2022/706114443849569/).
PNG
media_image1.png
822
1895
media_image1.png
Greyscale
In response to this requirement, if known, please provide answers to each of the following interrogatories eliciting factual information:
Based on the above video, Tomatillo Botero was highlighted at the Expo AgroAlimentaria 2022. Was Tomatillo Botero advertised for sale during that expo?
Was the public able to access tomatillo Botero during that expo? Please describe all access, including if samples were provided.
Provide all pamphlets, handouts, or materials about tomatillo Botero that were available to the public during the expo?
Were there any other materials associated with the event that were displayed or handed out to the public?
Was the Tomatillo Botero available for viewing at the expo?
Were any sale negotiations conducted during that expo for the Tomatillo Botero during that expo?
If Applicant views any or all of the above requested information as a Trade Secret, then Applicant should follow the guidance of MPEP § 724.02 when submitting the requested information.
In responding to those requirements that require copies of documents, where the document is a bound text or a single article over 50 pages, the requirement may be met by providing copies of those pages that provide the particular subject matter indicated in the requirement, or where such subject matter is not indicated, the subject matter found in applicant’s disclosure. Please indicate where the relevant information can be found.
The fee and certification requirements of 37 CFR § 1.97 are waived for those documents submitted in reply to this requirement. This waiver extends only to those documents within the scope of this requirement under 37 CFR § 1.105 that are included in the applicant’s first complete communication responding to this requirement. Any supplemental replies subsequent to the first communication responding to this requirement and any information disclosures beyond the scope of this requirement under 37 CFR § 1.105 are subject to the fee and certification requirements of 37 CFR § 1.97 if submitted subsequent to a first Office action on the merits.
The applicant is reminded that the reply to this requirement must be made with candor and good faith under 37 CFR § 1.56. Where the applicant does not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item.
This requirement is subject to the provisions of 37 CFR 1.134, 1.135 and 1.136, and has a shortened statutory period for reply to this action of THREE (3) MONTHS from the mailing date of this Office action. EXTENSIONS OF THIS TIME PERIOD MAY BE GRANTED UNDER 37 CFR 1.136(a).
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.
/Amjad Abraham/ SPE, Art Unit 1663