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 .
Claim Rejections - 35 USC § 112
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.
Claim 14 and 16 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.
Claim 14 is indefinite in its recitation of “A progeny plant produced by the method of claim 12, wherein said progeny is of tomato variety 72-CH2146 RZ”, it is not clear if the plant claimed therein is a progeny of is of tomato variety 72-CH2146 RZ, or if the progeny is a plant of tomato variety 72- CH2146 RZ. In the case of the latter, it would, one could interpret the claim to be limited to a plant with the all of the morphological and physiological characteristics of tomato variety 72-CH2146 RZ. In the case of former, the plant would be limited to any progeny of 72- CH2146 RZ produced by the method of claim 12. Therefore, the metes and bounds of claim 14 cannot be determined.
Claim 16 depends from claim 14 and, as it recites no limitations clarifying the metes and bounds of the claim from which it depends, is rejected on the same ground.
(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.
Enablement
Claims 1-30 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.
A. The deposit statement is not clear
The claims all require seed of hybrid tomato 72-CH2146 RZ.
Since the seed claimed 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.
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. If a seed is not so obtainable or available, a deposit 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 72- CH2146 RZ at the NCIMB and that the deposit was accepted pursuant to the terms of the Budapest Treaty (¶0036 ). The specification states “The deposit will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and for the enforceable life of the patent.” Irrevocably of release to the public does not end when the enforceable life of the patent ends. This rejection is made to ask Applicant to clarify and correct this statement.
For a deposit made and accepted under the terms of the Budapest Treaty, 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.
B. The specification does not teach how to make progeny of 72-CH2146 RZ with all the morphological and physiological characteristics of 72-CH2146 RZ.
Claims 8 and 9 are drawn to a plant produced by regenerating a tissue culture of the claimed plant variety, wherein the tissue culture may be of a segregating gametic cell such as a microspore and wherein said plant has all of the has all the morphological and physiological characteristics of 72-CH2146 RZ.
Claims 13-16 are drawn to progeny of a tomato plant of hybrid variety 72-CH2146 RZ, wherein the progeny has all of the morphological or physiological characteristics of 72-CH2146 RZ or at least a combination of traits or resistances including resistance to Meloidogyne incognita (Mi), Fusarium oxysporum f. sp. lycopersici race 0 (ex1) and race 1 (ex2) (Fol), Cladosporium fulvum (Ff) groups A, B, C, D, and E, resistance to Tomato Mosaic Virus (ToMV) strains 0, 1 and 2, Tomato yellow leaf curl virus (TYLCV), a short to medium plant height, bipinnate leaves, and very small, circular, red, firm fruit or is modified in any number of characteristics. Given that the metes and bounds of claim 14 are unclear, for the purpose of examination the claim is interpreted to read on a progeny that is a plant of variety 72-CH2146 RZ and therefore comprises all of the morphological and physiological characteristics of 72-CH2146 RZ .The specification does not teach how to make a progeny of 72-CH2146 RZ with all of these morphological and physiological characteristics of 72-CH2146 RZ.
Hybrid variety 72-CH2146 RZ is an F1 hybrid from a cross of two tomato lines (¶0056). When an F1 hybrid is crossed to itself or another plant, crossing over will occur, producing a mixture of gametes that will all differ from one another. The plants resulting from selfing 72-CH2146 RZ are F2 progeny of 72-CH2146 RZ’s parents. These plants will segregate for all the traits in 72-CH2146 RZ’s parents. None will have all the morphological and physiological characteristics of 72-CH2146 RZ.
Similarly, plants produced by regeneration from said gametic tissue culture would also be expected to all be different from one another and none would be expected to be the same as the parental F1.
Further, progeny of 72-CH2146 RZ encompass plants produced by crossing 72-CH2146 RZ to another tomato plant. The specification does not teach any tomato plants that when crossed to 72-CH2146 RZ produce progeny with all the morphological and physiological characteristics of 72-CH2146 RZ.
Making large numbers of F1 progeny pr progeny produced by crossing 72-CH2146 RZ to another tomato plant and evaluating their morphological and physiological characteristics in an attempt to find a progeny with all the morphological and physiological characteristics of 72-CH2146 RZ as listed in Figure 1 would require undue experimentation, if it even possible to do.
Applicant has not overcome this unpredictability by making any progeny plant with all the morphological and physiological characteristics of 72-CH2146 RZ.
C. The specification does not teach polymorphisms that are indicative of 72-CH2146 RZ and/or that give rise to the expression of any one or more, or all, of the morphological and physiological characteristics of 72-CH2146 RZ.
Claims 28-29 are drawn to a method comprising detecting in a 72-CH2146 RZ plant polymorphisms that are indicative of 72-CH2146 RZ and/or that give rise to the expression of any one or more, or all, of the morphological and physiological characteristics of 72-CH2146 RZ.
The specification does not teach any polymorphism that is indicative of 72-CH2146 RZ as opposed to other tomato plants. The specification also does not teach any polymorphisms that give rise to the expression of any morphological and physiological characteristic of 72-CH2146 RZ, much less all of them.
One of skill in the art would need to use undue trial and error experimentation to attempt to find polymorphisms that give rise to the expression of even one morphological and physiological characteristic of 72-CH2146 RZ, much less all of them.
Given the claim breath, lack of guidance in the specification, and nature of the invention as discussed above, the instant invention is not enabled.
Written Description
Claims 4, 6-7, 9, 15-16, 18 and 23 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 15-16 are drawn to progeny of a tomato plant of hybrid variety 72-CH2146 RZ, wherein the progeny has all of the morphological or physiological characteristics of 72-CH2146 RZ or at least a combination of traits or resistances including resistance to Meloidogyne incognita (Mi), Fusarium oxysporum f. sp. lycopersici race 0 (ex1) and race 1 (ex2) (Fol), Cladosporium fulvum (Ff) groups A, B, C, D, and E, resistance to Tomato Mosaic Virus (ToMV) strains 0, 1 and 2, Tomato yellow leaf curl virus (TYLCV), a short to medium plant height, bipinnate leaves, and very small, circular, red, firm fruit and wherein the progeny are modified in any number of characteristics. Given that the metes and bounds of claim 14 are unclear, for the purpose of examination the claim is interpreted to read on a progeny that is a plant of variety 72-CH2146 RZ and therefore comprises all of the morphological and physiological characteristics of 72-CH2146 RZ .
Hybrid variety 72-CH2146 RZ is an F1 hybrid from a cross of two tomato lines (¶49-50). When an F1 hybrid is crossed to itself or another plant, crossing over will occur, producing a mixture of gametes that will all differ from one another. The resulting progeny plants produced from the cross will have a mixture of genotypes; no two will be identical. The plants resulting from selfing 72-CH2146 RZ are F2 progeny of 72-CH2146 RZ’s parents. These plants will segregate for all the traits in 72-CH2146 RZ’s parents.
Further, progeny of 72-CH2146 RZ encompass plants produced by crossing 72-CH2146 RZ to another tomato plant. These plants will segregate for all the traits in 72-CH2146 RZ’s parents and in the other tomato plant.
The plants of claim six are drawn to any modification of any combination of traits of this already vast of genus of progeny.
The specification does not describe the structural features that distinguish tomato plant that are a member of the very large genus of 72-CH2146 RZ progeny with any number of trait modifications from a tomato plant that is not a 72-CH2146 RZ progeny.
Claims 4, 6, and 7 are drawn to 72-CH2146 RZ plant parts, including pollen, ovules, and cells, and tissue culture from 72-CH2146 RZ. Production of pollen and ovules involves crossing over, resulting a mixture of gametes that will all differ from one another; each pollen and ovule and ovule will have a different of these gametes.
The specification does not describe the structural features that distinguish pollen and ovules that are members of the very large genus of 72-CH2146 RZ pollen and ovules from pollen and ovules that are not 72-CH2146 RZ pollen and ovules.
Claims 18 and 23 are drawn to a plant produced by introducing a mutation or transgene into a 72-CH2146 RZ plant.
Introducing a transgene into a 72-CH2146 RZ plant encompasses doing so by crossing a 72-CH2146 RZ plant with a plant with the transgenes. As above this results in plants that segregate for all the traits in 72-CH2146 RZ’s parents and in the other tomato plant.
The specification does not describe the structural features that distinguish tomato plant that are a member of the very large genus of transgene-containing 72-CH2146 RZ progeny from a transgene-containing tomato plant that is not a 72-CH2146 RZ progeny.
There is no limit to the number of mutations in claim 23. The claim thus encompasses plants with any number of mutations relative to 72-CH2146 RZ. The specification does not describe the structural features that distinguish a 72-CH2146 RZ plant with any number of mutations from other tomato plants.
Hence, Applicant has not, in fact, described plants or polymorphisms required by the claims, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Subject Matter Free of the Prior Art
The claims appear to be free of the prior art. The closest prior art is Pérez Rodríguez 2021 (11,191,244 B2), which teaches hybrid Tomato Variety 74-132 RZ, which is a cherry type tomato with a truss inflorescence. While hybrid Tomato Variety 74-132 RZ and the instant variety share many physiological and morphological characteristics, they differ in at least fruit color, disease resistance and parental genetics.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEKSANDAR RADOSAVLJEVIC whose telephone number is (571)272-8330. The examiner can normally be reached Monday--Friday 8-5:30.
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, Shubo (Joe) Zhou can be reached at 571-272-0724. 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.
/ALEKSANDAR RADOSAVLJEVIC/Examiner, Art Unit 1662
/BRENT T PAGE/Primary Examiner, Art Unit 1663