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 .
Information Disclosure Statement
The Information Disclosure Statements filed on 8/20/2024 have been entered and considered. Initialed copies of the form PTO-1449 are enclosed with this action.
Status of claims
Claims 1-30, filed 8/20/2024, are pending and examined in the office action.
Priority
Instant application 18809939, filed 08/20/2024, claims priority from Provisional Application 63535730, filed 08/31/2023, which is recognized.
Claim Objections
Claim 30 is objected to because of the following informality:
The claim recites “wherein the one or more tomato fruits are according to claim 26”.
“According to” is fine in general when refers to a method or a principle. However, claim 26 is drawn to a fruit.
It is suggested to change “are according to claim 26” to --- the fruit of claim 26 ---, for “full, clear, and exact terms”.
See the requirement of 37 CFR 1.71(a) for “full, clear, and exact terms”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claim 26 and dependent claims 27 and 30 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 pre-AIA the applicant regards as the invention.
Claim 26 recites “the physiological and morphological characteristics of the fruit are as found in tomato variety 72-PL0501 RZ”.
The metes and bounds are unclear, and the claim is confusing, because:
First, regarding the “are as found in”, the physiological and morphological characteristics of the fruit is not the same as the physiological and morphological characteristics of the plant (tomato variety 72-PL0501 RZ). For example, the later comprises plant height, leaf color, and more, the former does not comprise them (see instant FIG 1A).
Second, the recitation is “the physiological and morphological characteristics”, not “all of the physiological and morphological characteristics”. Hence, it is unclear what and which characteristics is required? and what and which characteristics is not?
Dependent claims do not cure the deficiency, thus, are included.
Appropriate corrections are clarifications are required for one skill in the art to make and use the claimed invention.
Lacking written description
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.
Claims 13-16, 23 are rejected under 35 U.S.C. 112(a), 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.
To claim a genus under the written description requirement, the applicant is required to describe a representative number of species to reflect the variation within the genus or structures sufficient to define the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combinations thereof.
By court' s statement in Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), a written description of an invention “requires a precise definition, such as a structure, formula, or chemical name, of the claimed subject matter sufficient to distinguish it from other materials”; further, a written description of a claimed genus requires a description of a representative number of species of the claimed genus, and one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”.
Regarding claims 13-16
Claims 13 and 14 are drawn to a genus of progeny plants produced by the method of claim 12 comprising crossing 72-PL0501 RZ with itself or with another plant.
The claims do not require the progenies to be F1 generation progenies. Thus, a genus of tomato plants produced by the method of claim 12, are or encompass progenies of 72-PL0501 RZ of F2 generation and beyond.
The specification does not describe any F2 progeny of 72-PL0501 RZ, inbred, or hybrid, the physiological and morphological characteristics thereof, not to mention the common structure feature of F2 progenies and beyond. The specification does not describe a single species of F2 progeny of 72-PL0501 RZ. In fact, the specification does not even describe a single species of F1 progeny of 72-PL0501 RZ.
In the art, Foolad (Genome Mapping and Molecular Breeding of Tomato. International Journal of Plant Genomics, p1-52, 2007) teaches that cultivated tomatoes have dominant and recessive genes (p7, left col, 1st para to right col, 1st para; p18, left col, 2nd para; p31, right col, 1st para; p33, right col, 1st para). Foolad also teach that the genetic structures are diversified within the cultivated species (p11, left col, last para), and that in F1 hybrids, there are excessive variations including undesirable variations in traits/physiological and morphological characteristics (p14, right col, 1st para). Foolad further teaches that from generation to generation of backcrossing of tomatoes, the genetic constitution changes, and the traits/physiological and morphological characteristics are instable in F2 and F3 generations (p14, right col, 1st to 2nd para).
Hence, in the instant case, the physiological and morphological characteristics of the claimed genus of progeny plants are also heterologous (each species is different), and likely very different from that of the original 72-PL0501 RZ.
According to Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification. In this case, there is no way that a practitioner would be able to determine if any particular maize plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
Accordingly, the claims read on higher filial generation seeds, plants and parts that have any number of genomic, phenotypic and morphological changes in comparison to the variety 72-PL0501 RZ. The different plants have can have different genomic, phenotypic and morphological characteristics, including different transgenes. In addition, the genus of seeds, plants and parts may loss the structural, physiological and morphological characteristics of seed and plant of the variety by generations of crossing.
Dependent claims 15 and 16 not only do not cure the deficiency, but also have further deficiencies, as analyzed below.
Regarding claims 23, and claims 15-16
According to the specification ([0028]), “progeny of the hybrid tomato variety 72-PL0501 RZ can be modified in one or more other characteristics, in which the modification is a result of, for example and without limitation, mutagenesis or transformation with a transgene.
According to the specification ([0054]), mutations can be made by many different means including temperature, long-term seed storage, tissue culture conditions, radiation (such as X-rays, Gamma rays, neutrons, Beta radiation, or ultraviolet radiation), chemical mutagens (such as base analogs like 5-bromo-uracil), antibiotics, alkylating agents (such as sulfur mustards, nitrogen mustards, epoxides, ethyleneamines, sulfates, sulfonates, sulfones, or lactones), azide, hydroxylamine, nitrous acid or acridines, and so on.
Thus, claim 23 is drawn to a genus of tomato plants produced by the method of claim 22 comprising introducing mutations into 72-PL0501 RZ, by mutagenesis like gamma rays.
Claims 15-16 are drawn to the genus of progeny plants of claims 13-14 being modified in one or more characteristics, including by mutagenesis like gamma rays.
The specification does not describe any tomato plant 72-PL0501 RZ further comprising any mutation, not to mention a genus of mutations.
In prior art, Meric et al (Profile‑based proteomic investigation of unintended effects on transgenic and gamma radiation induced mutant soybean plants. Genet Resour Crop Evol 70: p2077–2095, 2023) teach and demonstrated that mutagenesis by gamma ray to plants caused significant changes in expression of many proteins in the resultant mutants (p2086-2089, Fig 4). Meric et al demonstrated and summarized that both mutagenesis and transgene introduction lead to (random and unintended) changes in metabolic functions of differential expressed proteins as compared to that of the control plants (p2086-2089, Fig 4; p2089, fig 5). Meric et al further teach and demonstrated that gamma irradiation causes mutations in multiple sites simultaneously and induces genome-wide variations compared to transgenesis (p2092, right col, 2nd para). Thus, mutagenesis by gamma rays does not lead to a single mutation.
Accordingly, the claimed plants and progeny plants likely significantly changed physiological and morphological characteristics from the original 72-PL0501 RZ in a random and unpredicted manner.
Regarding the aspect of representative number of species, 72-PL0501 RZ is the only species described by the specification. 72-PL0501 RZ is not a progeny plant, and does not further comprise any mutation(s).
The specification does not describe any species of F2 progeny nor any species further comprising any mutation(s).
The inbred and hybrid progenies of F2 generation and beyond of 72-PL0501 RZ are an extremely large number, and are heterologous in structure.
Given the mutations are generic not specific, the mutant tomato plants are an extremely large number, and are heterologous in structure.
Hence, 72-PL0501 RZ does not describe the common structure feature of the genera of tomato plants, and does not represent (not to mention sufficiently represent) the genus of the tomato plants as broadly claimed.
Therefore, the application has not met either of the two elements of the written description requirement as set forth in the court' s decision in Eli Lilly, and has not shown her/his possession of the claimed genera.
For compact prosecution, the following suggestion are made:
Amending claims 13-14 to --- F1 progeny --- would overcome the rejection to claims 13-15.
Amending claims 15-16 to --- is modified via transformation --- would overcome the rejection to claims 15-16.
Amending claim 22 from “a mutation or transgene” to --- a transgene --- would overcome the rejection to claim 23.
Remarks
Instant 72-PL0501 RZ/NCIMB 44409, does not have prior art in patents or NPLs. Prior art does not teach any tomato plant having all of the physiological and morphological characteristics, and genetic background, of FDR-A818-0234 or SVTH3562.
According to the specification ([0057]-[0059]), hybrid tomato variety 72-PL0501 RZ was developed by crossing two stable parent lines. Both parent lines were developed in Netherland by RijkZwaan. The female parent line PLT2481F is a F3BC3. It started as BPT063 breeding line of RijkZwaan in 2012 and was crossed with BPT064. The male parent line PLT2482M is a F2BC3. It started as HT0665 in 2006 which originated from a breeding line of RijkZwaan. It was crossed with BPT065.
PLT2481F, or PLT2481, the female parent, by name search, does not have prior art in patents or NPLs. The combination of BPT063 and BPT064 (parents of PLT2481F) does not have in patents or NPLs.
PLT2482M, or PLT2482, the male parent, by name search, does not have prior art in patents or NPLs. The combination of BPT063 and BPT064 (parents of PLT2482M) does not have in patents or NPLs.
The combination of the parent lines PLT2481F and PLT2482M does not have prior art in patents or NPLs. Thus, prior art does not disclose any sibling(s) of instant 72-PL0501 RZ.
Notes:
Regarding claims 9 and 14, the claimed traits are the traits of instant 72-PL0501 RZ disclosed in the specification (Fig 1B), not further comprised traits.
Claims 28-29 are not rejected under 35 USC 101, because 72-PL0501 RZ is deemed a new tomato plant. Thus, determining the genotype of a/the new tomato plant is not deemed a routine method.
Conclusion
Claims 1-12, 17-22, 24-25, 28-29 are allowed.
Claims 13-16, 23, 26-27, 30 are rejected.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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/Wayne Zhong/
Primary Examiner, Art Unit 1662