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 .
Election/Restrictions
1. Applicant’s election without traverse of Group I (claims 1 (part), 3, 6, 8, 14, 15, 17 (part) and 36), and SEQ ID NO: 214 encoding the TFL polypeptide of SEQ ID NO: 216 and the region of SEQ ID NO: 216 encoding the polypeptide of SEQ ID NO: 272) in the reply filed on April 30, 2026 is acknowledged. It may be noted that SEQ ID NO: 215 is the cDNA version of genomic sequence of SEQ ID NO: 214 which encodes the elected SEQ ID NO: 216 polypeptide comprising the sequence of SEQ ID NO: 272. It is also noted that elected SEQ ID NO: 224 is comprised by the cDNA sequence of SEQ ID NO: 215.
Claims 12, 64, 69, 70, 72, 73, 76-78, 88, 90 and 91 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Claim 17 is directed to non-elected subject matter is also withdrawn as being drawn to a nonelected inventions. Claims 2, 4, 5, 7, 9-11, 13, 16, 18-35, 37-63, 65-68, 71, 74-75, 79-87, 89 and 92-96 are cancelled by the Applicant.
Accordingly claims 1, 3, 6, 8, 14, 15 and 36 in conjunction with the nucleotide sequence of SEQ ID NO: 214 (SEQ ID NO: 215 cDNA) encoding the TFL polypeptide of SEQ ID NO: 216, and the region of SEQ ID NO: 224 encoding the polypeptide of SEQ ID NO: 272 are examined on merits in the present Office action. This restriction is made Final.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
2. Initialed and dated copies of Applicant’s IDS form 1449 filed in the papers 09/26/2024, 03/20/2025 and 04/30/2026 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
3. Claim 1 objected to because of the following informalities:
Claim 1 is objected for having non-elected subject matter. Non-elected subject matter includes all SEQ ID NOs., except elected SEQ ID NOs: 214, 216, 224 and 272.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
4. Claims 1, 3, 6, 8, 14, 15 and 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1: Statutory Category
The claims are directed to a Rosaceae plant or plant part, which is a composition of matter. Therefore, the claims fall within a statutory category of invention.
Step 2A, Prong 1: Judicial Exception
The claims recite a Rosaceae plant comprising a mutation in an endogenous TERMINAL FLOWER (TFL) gene. The mutation includes substitutions, deletions, and/or insertions. These types of genetic variations are known to occur naturally through spontaneous mutation and natural breeding processes. Because the claimed plant is defined by a naturally occurring gene and mutations that can arise in nature, the claims are directed to a product of nature. The sequence identity limitations (e.g., at least 80%) further encompass naturally occurring genetic variants rather than limiting the claim to a non-natural construct. It is important to note the recitation “at least one mutation” in parent claim 1 reads on any number of mutation and, thus compasses any endogenous TFL gene in any Rosaceae plant that may have mutation in wild. See for example, Iwata et al. (The Plant Journal, 69:116-125, 2012) who teach naturally occurring TFL mutant of strawberry (Rosaceae plant) having naturally occurring 2 bp deletion in TFL gene which alters flower timing. The 2 bp deletion results in loss of functional TFL protein (see in particular, abstract, Figs. 3-6 including supplementary data). This finding is further substantiated by Koskela et al. (Plant Physiol., 159:1043-1054, 2012) who teach naturally occurring mutation(s) in TFL1 homologs in Rosaceae plant strawberry (Frageria vesca) exhibit altered flowering associated with mutated TFL1 gene in the wild (see in particular, abstract, Figs. 1-8 at pages 1045-1050).
This is consistent with Association for Molecular Pathology v. Myriad Genetics, Inc., where naturally occurring DNA sequences were found not to be patent eligible. Unlike Diamond v. Chakrabarty, the claims do not require a genetically engineered organism with markedly different characteristics from any found in nature.
Step 2A, Prong 2: Practical Application
The claims do not integrate the natural phenomenon into a practical application. There is no requirement for a specific method of creating the mutation, such as genetic engineering or laboratory manipulation.
The phenotypic traits recited in Claim 14, including reduced flowering time and improved yield, are merely natural results of the mutation. These characteristics do not impose meaningful limits on the claim but instead describe inherent properties of the naturally occurring genetic variation. As explained in Mayo Collaborative Services v. Prometheus Laboratories, Inc., simply identifying a natural relationship without applying it in a specific, inventive way does not render a claim patent eligible.
Step 2B: Significantly More
The claims do not recite additional elements that amount to significantly more than the judicial exception. The types of mutations listed are routine and conventional in the field of genetics. There is no recitation of a specific transformation technique, engineered construct, or non-natural genetic modification. Claim 36, which recites a regenerated plant, reflects routine and conventional plant propagation.
The claims are broad enough to cover any Rosaceae plant with a qualifying TFL mutation, regardless of how the mutation arose. This breadth indicates that the claims are directed to the natural phenomenon itself. This reasoning is consistent with Funk Brothers Seed Co. v. Kalo Inoculant Co., where naturally occurring biological properties were not considered patentable.
Conclusion
The claims are directed to a naturally occurring plant with naturally occurring genetic mutations and do not include additional elements that amount to significantly more than the exception. Therefore, the claims are not directed to patent-eligible subject matter under 35 U.S.C. § 101.
Suggestions: It is suggested to amend the claims by reciting “a non-naturally occurring transgenic genome-edited Rosaceae plant…” and recite a specific engineered mutation not shown in nature, plus evidence of a markedly different phenotype/genotype compared with naturally occurring Rosaceae plants.
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.
5. Claims 1, 3, 6, 8, 14, 15 and 36 are rejected are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a transgenic Rosaceae plant, comprising reducing or eliminating expression of endogenous TFL1 protein as set forth in SEQ ID NO: 216 and encoded by SEQ ID NO: 214 in blackberry plant by transforming blackberry plant with a recombinant CRISPR/Cas9 vector targeted to knock-out or silence expression of said endogenous TFL1 protein as set forth in SEQ ID NO: 216 which is encoded by SEQ ID NO: 214), and wherein said transgenic blackberry plant was developed to alter flowering time, does not reasonably provide enablement for (i) reducing or eliminating expression of any endogenous TLP gene in any Rosaceae plant having a nucleotide sequence having 80% identity to SEQ ID NOs: 214 and 224, and encoding proteins having 80% identity to SEQ ID NOs: 216 and 272, respectively, and silencing or eliminating expression of endogenous SEQ ID NOs: 214 comprising SEQ ID NO: 224 and encoding SEQ ID NO: SEQ ID NO: 216 which comprises SEQ ID NO: 272 in a in any Rosaceae plant blackberry by a method that does not comprise transforming said Rosaceae plant blackberry with a CRISPR/Cas9 vector targeted to knock-out or silence expression of Rosaceae endogenous TFL1 protein as set forth in SEQ ID NO: 216 (comprises SEQ ID NO: 272) which is encoded by SEQ ID NO: 214 (comprises SEQ ID NO: 224). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Claims are broadly drawn to a Rosaceae plant or part thereof comprising at least one mutation in an endogenous TERMINAL FLOWER (TFL) gene encoding a TFL polypeptide, wherein the endogenous TFL gene encoding the TFL polypeptide comprises a sequence having at least 80% sequence identity to 214, comprises a region having at least 80% sequence identity to the nucleotide sequences of SEQ ID NO: 224, encodes a TFL polypeptide having at least 80% sequence identity to the amino acid sequences of SEQ ID NO: 216, and/or encodes a region having at least 80% sequence identity to any one of the amino acid sequences of 272, or wherein the at least mutation is a base substitution, a base deletion and/or a base insertion, or wherein the at least one mutation is a base deletion of about 1 base pair to about 100 consecutive base pairs, about 3 base pairs to about 2600 base pairs, or about 3 base pairs to about 519 base pairs, or wherein the at least one mutation in the endogenous TFL gene results in a truncated TFL polypeptide and/or no detectable TFL polypeptide, or the Rosaceae plant comprising the at least one mutation exhibits a phenotype of reduced time to flowering, a longer duration of flowering, a more determinate plant growth pattern and/or one or more improved yield characteristics compared to a control Rosaceae plant, or, wherein the Rosaceae plant is a cane berry or stone fruit, optionally wherein the Rosaceae plant is a blackberry, a black raspberry, a cherry, a plum or a peach, or a Rosaceae plant regenerated from the Rosaceae plant part.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Claim 1 and claims dependent thereon are directed to any Rosaceae plant having at least one mutation in any endogenous TFL gene comprising a nucleotide sequence which has 80% identity to SEQ ID NO: 214, comprising a region having 80% identity to SEQ ID NO: 224, and encoding a TFL polypeptide having 80% identity to SEQ ID NO: 216 and/or which has a region having 80% identity to SEQ ID NO: 272, wherein said plant exhibits reduced time to flowering, a more determinate growth pattern and/or one or more improved yield characteristics compared to a control Rosaceae plant.
The instant specification fails to provide guidance on how to make nucleic acid sequences comprising 80% sequence identity to instant SEQ ID NO: 214 and comprising a nucleotide sequence having 80% identity to SEQ ID NO: 224.
Nucleic acid sequences with 80% identity to instant SEQ ID NO: 214 would have 1168 substitutions relative to 5843 nucleotides of SEQ ID NO: 216; these encompass polynucleotide sequences that either code no protein or encode proteins with 1168 amino acid substitutions relative to SEQ ID NO: 216 (only 172 aa long). These proteins would have 0% identity to SEQ ID NO: 216.
Nucleic acid sequences with 80% identity to instant SEQ ID NO: 224 would have 44 substitutions relative to 103 nucleotides of SEQ ID NO: 224; these encompass polynucleotide sequences that either encode no protein or encode proteins with 103 amino acid substitutions relative to SEQ ID NO: 272 (only 27 aa long). These proteins would have 0% identity to SEQ ID NO: 224.
Making all possible single amino acid substitutions in an 172 amino acid long protein like that encoded by SEQ ID NO: 216 would require making and analyzing 19172 nucleic acid sequences; these proteins would have 99.5% identity to SEQ ID NO: 216.
Making all possible single amino acid substitutions in an 27 amino acid long protein like that encoded by SEQ ID NO: 272 would require making and analyzing 1927 nucleic acid sequences; these proteins would have 96% identity to SEQ ID NO: 272.
Because nucleic acid sequences having 80% sequence identity to SEQ ID NO: 214 or SEQ ID NO: 272 would encode proteins with 0% sequence identity to the 172 amino acid long SEQ ID NO: 214 or 27 amino acid long SEQ ID NO: 272 which would encode proteins with 100% amino acid substitutions relative to SEQ ID NO: 216 or SEQ ID NO: 272, many more than 19172nucleic acid sequences would need to be made and analyzed.
The instant specification fails to provide guidance on how to make nucleic acid sequences encoding a polypeptide having 80% sequence identity to SEQ ID NO: 216.
Nucleic acid sequences having 80% sequence identity to the 172 amino acid long SEQ ID NO: 216 would encode proteins with 34 amino acid substitutions relative to SEQ ID NO: 216.
Making all possible single amino acid substitutions in an 172 amino acid long protein like that encoded by SEQ ID NO: 216 would require making and analyzing 19172 nucleic acid sequences; these proteins would have 99.5% identity to SEQ ID NO: 216.
Because nucleic acid sequences encoding proteins with 80% sequence identity to the 172 amino acid long SEQ ID NO: 216 which would encode proteins with 34 amino acid substitutions relative to SEQ ID NO: 216, many more than 19172 nucleic acid sequences would need to be made and analyzed.
Nucleic acid sequences having 80% sequence identity to the 27 amino acid long SEQ ID NO: 272 would encode proteins with 5 amino acid substitutions relative to SEQ ID NO: 272.
Making all possible single amino acid substitutions in an 27 amino acid long protein like that encoded by SEQ ID NO: 272 would require making and analyzing 1927 nucleic acid sequences; these proteins would have 96.2% identity to SEQ ID NO: 272.
Because nucleic acid sequences encoding proteins with 80% sequence identity to the 27 amino acid long SEQ ID NO: 272 which would encode proteins with 5 amino acid substitutions relative to SEQ ID NO: 272, many more than 1927 nucleic acid sequences would need to be made and analyzed.
The specification at page 74, lines 1-4 says:
”In some embodiments, the TFL gene (a) comprises a nucleotide sequence having at least 80% % sequence identity (e.g., 80, 81, 82, 83, 84, 85, 86, 87, 88, 89,90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100%, optionally about 90, 91, 92, 93, 94, 95, 96, 97,98, 99, or 100% or about 95, 96, 97, 98, 99, or 100% sequence identity) to any one of SEQ ID NOs.”
Thus, from the guidance in the specification, it would appear that the vast majority of the amino acids in SEQ ID NO: 216 comprising SEQ ID NO: 272 could be substituted with any other amino acid.
The instant specification fails to provide guidance for which amino acids of SEQ ID NO: 216 comprising SEQ ID NO: 272 can be altered and to which other amino acids, and which amino acids must not be changed, to maintain the functional activity of the encoded protein so that it can assigned a functional TFL1 protein so that it can be mutated to see its impact on plant phenotype, such as flowering, yield etc.
The instant specification, however, only provides guidance on transformation of blackberry plants with recombinant CRISPR/Cas9 vectors targeted to knockout or silence expression of blackberry endogenous gene as set forth in SEQ ID NO: 214 encoding TFL protein of SEQ ID NO: 216. The transgenic mutant blackberry plants exhibited improved blackberry plant characteristics. The specification states that by editing expression of SEQ ID NO: 214, it would result in alteration of flowering time. See in particular, Example 1, Table 1 at pages 102-103.
The state of the art related with TFL1 genes expression suggests that a single amino acid change in Terminal Flower (TFL1) repressor protein converts its repressor function to an activator having FT (Flowering locus) function in flowering. See Hanzawa et al. (PNAS, 102:7748-7753, 2005; see in particular, abstract, Figures 1-5).
Thus one of skilled in the art would not expect all TFL genes having 80% identity to SEQ ID NO: 214 and comprising a sequence having 80% identity to SEQ ID NO: 224 would cause instantly claimed improved characteristics upon reducing or eliminating expression in a plant, such as Rosaceae plant.
The specification does not teach disruption of which TLF1 gene expression in a Rosaceae plant would confer an economically important trait upon mutation and which would not as encompassed by the breadth and scope of claims.
In the absence of adequate guidance provided in the specification, it would require undue experimentation to determine which TLF1 gene having 80% identity to instantly elected SEQ ID NO: 214 comprising a sequence having 80% identity to SEQ ID NO: 224 would confer an economically useful trait upon reducing, silencing or knocking out its expression and which won’t.
Given the claim breadth, unpredictability, and lack of guidance as discussed above, undue experimentation would have been required by one skilled in the art to develop and evaluate large TLF1 derived from diverse Rosaceae source to determine would produce a useful phenotype upon knocking out their expression in a plant. See Genentech, Inc. v. Novo Nordisk, A/S,USPQ2d 1001, 1005 (Fed. Cir. 1997), which teaches that “the specification, not the knowledge of one skilled in the art” must supply the enabling aspects of the invention.
The instantly claimed invention encompasses using, for example, chemical, non-chemical based random mutagenesis, T-DNA integration, CRISPR/Cas9 based, ZFN, TALEN, and Meganucleases, etc. gene suppression methods to create transgenic plants or parts thereof exhibiting suppression of endogenous TFL1 gene of SEQ ID NO: 214 and comprising SEQ ID NO: 224 in diverse Rosaceae plant species as encompassed by the breadth of claims to improve a Rosaceae plant trait characteristics as claimed.
The instant specification, however, only provides guidance on transformation of blackberry plants with recombinant CRISPR/Cas9 vectors targeted to knockout or silence expression of blackberry endogenous gene as set forth in SEQ ID NO: 214 encoding TFL protein of SEQ ID NO: 216. The transgenic mutant blackberry plants exhibited improved blackberry plant characteristics. The specification states that by editing expression of SEQ ID NO: 214, it would result in alteration of flowering time. See in particular, Example 1, Table 1 at pages 102-103.
For example, claims encompass down-regulating expression of endogenous TFL1 gene of SEQ ID NO: 214 and comprising SEQ ID NO: 224 in diverse Rosaceae plant species by T-DNA insertion mutagenesis. State of the art related with T-DNA mutagenesis is itself a highly unpredictable technique. See for example, Bonawitz et al. (Annu. Rev. Genet. 44: 337-363, 2010) who teach that T-DNA insertional mutants in Arabidopsis with a complete block in the monolignol biosynthetic pathway (enzymes involved in lignin biosynthesis) resulted in the developmental growth arrest at the seedling stage. See in particular, page 353, 2nd paragraph of right column. In the absence of adequate guidance, it would require undue experimentation to determine how to make and use the claimed product for the full scope of down-regulating expression of endogenous TFL1 gene having 80% identity to SEQ ID NO: 214 and comprising a sequence having 80% identity to SEQ ID NO: 224 in diverse Rosaceae plant species as encompassed by the breadth and the scope of the claims.
Likewise, claims encompass reducing or eliminating the expression of TLF1 genes having 80% identity to SEQ ID NO: 214 and comprising a sequence having 80% identity to SEQ ID NO: 224 in diverse Rosaceae plant species using genome editing technique (e.g. CRISPR/Cas system).
The state of art related with CRISPR/Cas9 (Paul et al., Plant Cell Reports; 35:1417-1427; 2016) clearly suggests that the efficiency of Cas9 editing among plants depends on plant species, genomic loci targeted, expression levels of gRNA and Cas9, among other factors. The reference further teaches that Cas9:gRNA complexes routinely result off-target binding and cleavages which can result in unwanted mutations and chromosomal abnormalities. See in particular, last four lines of last paragraph of left column on page 1418.
In the absence of adequate guidance, it would require undue experimentation, to design CRISPR/Cas9 system specifically targeting endogenous TFL1 gene having 80% identity to SEQ ID NO: 214 and comprising a sequence having 80% identity to SEQ ID NO: 224 in diverse Rosaceae plant species in any plant species to produce the claimed product as encompassed by the breadth and scope of the claims.
Likewise, claims encompass reducing or eliminating the expression of any endogenous TFL1 gene of SEQ ID NO: 214 and comprising SEQ ID NO: 224 in diverse Rosaceae plant species using engineered nucleases. However, Yee et al. (The FEBS Journal, 283:3329-3248, 2016) discusses major complications using engineered nucleases (such as but not limited to ZFN, TALEN, Meganucleases and CRISPR -associated Cas9), binding to unintended genomic sites that share sequence homology with the on-target site. The reference further teaches that cleavage of such off-target sites by the nucleases followed by indel formation with Non-Homologous End Joining (NHEJ) results in unintended inactivation or mutation. Such unintended consequences lead to severe adverse events affecting cell function and proliferation. See in particular, paragraph bridging paragraphs left and right columns on page 3241.
In the absence of adequate guidance, it would require undue experimentation, to design engineered nucleases (such as but not limited to ZFN, TALEN, Meganucleases and CRISPR-associated Cas9) specifically targeting endogenous TFL1 gene having 80% identity to SEQ ID NO: 214 and comprising a sequence having 80% identity to SEQ ID NO: 224 in diverse Rosaceae plant species to produce the product with specific traits as encompassed by the breadth and scope of the claims.
Thus in the absence of adequate guidance from the specification, undue trial and error experimentation would be required to screen through the myriad of nucleic acids encompassed by the claims and plant cells or plants transformed therewith to identify those with improved characteristics as claimed upon reducing or eliminating the expression of any endogenous TFL1 gene including sequences having 80% identity to SEQ ID NO: 214 and comprising a sequence having 80% identity to SEQ ID NO: 224 in diverse Rosaceae plant species.
Claims also encompass improving instantly claimed characteristics in a Rosaceae plant by a process that does not comprise transforming said Rosaceae plant with a an expression cassette that will result in intended mutations in SEQ ID NO: 214 (encoding SEQ ID NO: 216) and comprising SEQ ID NO: 224 (encoding SEQ ID NO: 272).
The instant specification, however, only provides guidance on transformation of blackberry plants with recombinant CRISPR/Cas9 vectors targeted to knockout or silence expression of blackberry endogenous gene as set forth in SEQ ID NO: 214 encoding TFL protein of SEQ ID NO: 216. The transgenic mutant blackberry plants exhibited improved blackberry plant characteristics. The specification states that by editing expression of SEQ ID NO: 214, it would result in alteration of flowering time. See in particular, Example 1, Table 1 at pages 102-103.
The specification, however, fails to provide guidance on improving instantly claimed characteristics in a plant in any manner other than transforming a blackberry plant with a recombinant CRISPR/Cas9 vectors targeted to knockout or silence expression of blackberry endogenous SEQ ID NO: 214 comprising SEQ ID NO: 224, to overexpress to produce a Rosaceae plant with instantly claimed improved characteristics. The specification provides no guidance on up-stream regulatory factors, for example, that may be necessary in stimulating the down-regulation of SEQ ID NO: 214 encoding SEQ ID NO: 216 and comprising SEQ ID NO: 224 encoding SEQ ID NO: 272, to impart instantly claimed improved characteristics to the Rosaceae plant.
In the absence guidance, undue experimentation would have been required by a skilled artisan at the time the claimed invention was made to determine how a plant with instantly claimed improved characteristics could have been produced comprising decreasing or eliminating the expression of SEQ ID NO: 214 encoding SEQ ID NO: 216 and comprising SEQ ID NO: 224 encoding SEQ ID NO: 272, without transforming the Rosaceae plant with a recombinant CRISPR/Cas9 vectors targeted to knockout or silence expression of endogenous TLF1 gene as set forth in SEQ ID NO: 214 which comprises SEQ ID NO: 224 in a Rosaceae plant.
Given the breadth of the claims, unpredictability of the art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
6. Claims 1, 3, 6, 8, 14, 15 and 36 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has recently clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id.
Finally, the court held:
A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP Section 2163, page 174 of Chapter 2100 of the August 2005 version, column 1, bottom paragraph, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Claims are broadly drawn to a Rosaceae plant or part thereof comprising at least one mutation in an endogenous TERMINAL FLOWER (TFL) gene encoding a TFL polypeptide, wherein the endogenous TFL gene encoding the TFL polypeptide comprises a sequence having at least 80% sequence identity to 214, comprises a region having at least 80% sequence identity to the nucleotide sequences of SEQ ID NO:224, encodes a TFL polypeptide having at least 80% sequence identity to the amino acid sequences of SEQ ID NO: 216, and/or encodes a region having at least 80% sequence identity to any one of the amino acid sequences of 272, or wherein the at least mutation is a base substitution, a base deletion and/or a base insertion, or wherein the at least one mutation is a base deletion of about 1 base pair to about 100 consecutive base pairs, about 3 base pairs to about 2600 base pairs, or about 3 base pairs to about 519 base pairs, or wherein the at least one mutation in the endogenous TFL gene results in a truncated TFL polypeptide and/or no detectable TFL polypeptide, or the Rosaceae plant comprising the at least one mutation exhibits a phenotype of reduced time to flowering, a longer duration of flowering, a more determinate plant growth pattern and/or one or more improved yield characteristics compared to a control Rosaceae plant, or, wherein the Rosaceae plant is a cane berry or stone fruit, optionally wherein the Rosaceae plant is a blackberry, a black raspberry, a cherry, a plum or a peach, or a Rosaceae plant regenerated from the Rosaceae plant part.
Claim 1 and claims dependent thereon are directed to any Rosaceae plant having at least one mutation in any endogenous TFL gene comprising a nucleotide sequence which has 80% identity to SEQ ID NO: 214, comprising a region having 80% identity to SEQ ID NO: 224, and encoding a TFL polypeptide having 80% identity to SEQ ID NO: 216 and/or which has a region having 80% identity to SEQ ID NO: 272, wherein said plant exhibits reduced time to flowering, a more determinate growth pattern and/or one or more improved yield characteristics compared to a control Rosaceae plant.
Nucleic acid sequences with 80% identity to instant SEQ ID NO: 214 would encompass sequences encoding either no protein or encoding an unrelated protein having 0% identity to SEQ ID NO: 216.
Nucleic acid sequences with 80% identity to instant SEQ ID NO: 224 would encompass sequences encoding either no protein or encoding an unrelated protein having 0% identity to SEQ ID NO: 272.
Nucleic acid sequences having 80% sequence identity to the 172 amino acid long SEQ ID NO: 216 would encode proteins with 34 random amino acid substitutions/changes relative to SEQ ID NO: 216.
Nucleic acid sequences having 80% sequence identity to the 27 amino acid long SEQ ID NO: 272 would encode proteins with 5 random amino acid substitutions/changes relative to SEQ ID NO: 272.
The breadth of the claims encompass unknown and uncharacterized structures having the function of instantly claimed characteristics upon mutating said unknown structures to reduce or eliminate their expression their expression in diverse Rosaceae plant species, and having the instantly claimed function of reduced time to flowering, a longer duration of flowering, a more determinate plant growth pattern and/or one or more improved yield characteristics (see for example, claim 14)
Thus breadth of the claims encompass a large genus comprising unspecified structures with undescribed, unpredictable and unknown function(s).
The instant specification however, only describes transformation of blackberry plants with recombinant CRISPR/Cas9 vectors targeted to knockout or silence expression of blackberry endogenous gene as set forth in SEQ ID NO: 214 encoding TFL protein of SEQ ID NO: 216. The transgenic mutant blackberry plants exhibited improved blackberry plant characteristics. The specification states that by editing expression of SEQ ID NO: 214, it would result in alteration of flowering time. See in particular, Example 1, Table 1 at pages 102-103.
The specification does not describe the structure for representative members of Applicant’s broadly claimed genus comprising variants derived from diverse sources as encompassed by the breadth of claims and thus reducing or eliminating TFL1 expression levels of SEQ ID NO: 214 encoding SEQ ID NO: 216 in diverse mutant Rosaceae plant species, having instantly claimed traits (function) is either unknown or unpredictable.
The species (SEQ ID NO: 214 which comprises SEQ ID NO: 224, and encodes SEQ ID NO: 216 which comprises SEQ ID NO: 272) described in the specification is insufficient keeping in view of diversity among Rosaceae plant species..
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, instantly described species e.g. SEQ ID NOs: 214, 216, 224 and 272 are insufficient to describe the claimed genus.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claim(s) 1, 3, 6, 8, 14 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iwata et al. (The Plant Journal, 69:116-125, 2012).
Iwata disclose a Rosaceae plant or part thereof (strawberry) comprising at least one mutation in an endogenous TERMINAL FLOWER (TFL) gene encoding a TFL polypeptide, wherein the at least mutation is at least 2 base deletion, wherein the at least one mutation in the endogenous TFL gene results in a truncated TFL polypeptide and/or no detectable TFL polypeptide, , wherein said Rosaceae plant comprising the at least one mutation exhibits a phenotype of reduced time to flowering, as compared to a corresponding control Rosaceae plant, and wherein a Rosaceae plant regenerated from the mutant Rosaceae plant part. See in particular, abstract, Figs. 3-6 including attached supplementary data about mapping data.
This rejection is made because of following reason(s):
It is important to note the recitation “at least one mutation” in parent claim 1 reads on any number of mutation and, thus compasses any endogenous TFL gene in any Rosaceae plant that may have a mutation in wild.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claim(s) 1, 3, 6, 8, 14, 15 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Chawla et al. (US 2018/0092319 A1, Published April 5, 2018) and Contreras et al. (GenBank Sequence Accession NO. MF156853.1, Published November 13, 2018), and further in view Kurokkura et al. (Journal of Experimental Botany, 64:4131-4141, 2013, IDS).
Chawla et al. teach genetically modified strawberry plants having reduced activity of an endogenous TERMINAL FLOWER gene. Chawla et al. state that the genetically modified strawberry plants are of the genus Fragaria, which is a Rosaceae genus. Chawla et al. further teach that the reduced activity may be induced by RNA interference, genome editing, or mutation of the endogenous TFL gene. Chawla et al. also teach that introducing mutations into an endogenous TFL gene of a Fragaria plant may be accomplished by chemical mutagenesis, radiation mutagenesis, insertional mutagenesis, site-directed mutagenesis, and other mutagenesis methods. The limitation requiring a Rosaceae plant or part thereof comprising a mutation in an endogenous TFL gene is therefore taught or suggested by Chawla et al. teachings. Chawla et al. further teach that the endogenous TFL gene encodes a TFL polypeptide. Chawla et al. teach TFL1 coding sequences and corresponding TFL1 protein sequences, including SEQ ID NO:2, SEQ ID NO:5, and SEQ ID NO:7, and protein sequences SEQ ID NO:3, SEQ ID NO:6, and SEQ ID NO:8. Chawla et al. further teach sequence conservation among TFL polypeptides within Rosaceae species, demonstrating high sequence identity. The limitation requiring a TFL polypeptide and sequence identity to TFL sequences is therefore taught or suggested by Chawla et al. Chawla et al. further teach that repressing or eliminating expression of endogenous TFL1 genes in Rosaceae plants results in reduced time to flowering, a longer duration of flowering, and increased plant production. Chawla et al. also teach plant transformation-based methods using CRISPR/Cas-based gene editing systems targeting endogenous Rosaceae plant TFL genes to suppress or eliminate expression in Rosaceae plant cells. The limitation requiring phenotypic traits associated with reduced TFL1 activity is therefore taught by Chawla et al. See in particular, abstract; paragraphs [0030]-[0140]; [008], [0024], [0055], [0077], [0103], [0119]; [0102]-[0103]; Examples 1-6, Tables 1-19; claims 1-24;
The sequence homology results of SEQ ID NO: 6 of Chawla et al., and instant SEQ ID NO: 216 is shown as below:
US-15-720-264-6
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 6, US/15720264
Publication No. US20180092319A1
GENERAL INFORMATION
APPLICANT: J.R. Simplot Company
APPLICANT: Chawla, Rekha
APPLICANT: Krucker, Michele L
TITLE OF INVENTION: GROWING STRAWBERRY PLUG PLANTS AT LOW ELEVATION WITHOUT THE NEED
TITLE OF INVENTION: FOR CONDITIONING
FILE REFERENCE: JRSI-077/01US 317577-2564
CURRENT APPLICATION NUMBER: US/15/720,264
CURRENT FILING DATE: 2017-09-29
PRIOR APPLICATION NUMBER: 62/402,582
PRIOR FILING DATE: 2016-09-30
NUMBER OF SEQ ID NOS: 31
SEQ ID NO 6
LENGTH: 172
TYPE: PRT
ORGANISM: Fragaria x ananassa
Query Match 93.2%; Score 813; Length 172;
Best Local Similarity 90.1%;
Matches 155; Conservative 5; Mismatches 12; Indels 0; Gaps 0;
Qy 1 MARMSEPLVVGRVIGDVLDSFTPTTKMIVTYTTRHVSNGYELLPSAVTTKPRVEIQGGDM 60
|||||||| |||||||||||||||||||||| |: | ||:|| ||||| |||||||||||
Db 1 MARMSEPLAVGRVIGDVLDSFTPTTKMIVTYNTKLVCNGHELFPSAVTAKPRVEIQGGDM 60
Qy 61 RSFFTLVMTDPDXPGPSDPYLKEHLHWVVTDIPGTTDATFGREVVSYEMPRXNIGIHRFV 120
|||||||||||| ||||||||||||||:||||||||||||||||||||||| ||||||||
Db 61 RSFFTLVMTDPDVPGPSDPYLKEHLHWIVTDIPGTTDATFGREVVSYEMPRPNIGIHRFV 120
Qy 121 FVLFRQKRRQSVNPPXSRDXFNTRSFAAENDLGLPVAAVYFNXQRETAARRR 172
|||| |||||||||| ||| ||||:||||||||:|||||||| |||||||||
Db 121 FVLFMQKRRQSVNPPSSRDHFNTRTFAAENDLGVPVAAVYFNAQRETAARRR 172
Contreras et al. further teach an FTL1 coding and amino acid sequence from Rubus species, wherein the amino acid sequence taught by the reference has 97.3% identity to a TFL1 protein sequence. Contreras et al. therefore teach that TFL1 sequences are highly conserved across Rosaceae species and meet sequence identity limitations. See in particular, pages 1-2.
The sequence homology results of Contreras et al. FTL1 amino acid sequence and instant SEQ ID NO: 216 is shown as below:
A0A3G1RQ92_RUBID
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID A0A3G1RQ92_RUBID Unreviewed; 172 AA.
AC A0A3G1RQ92;
DT 13-FEB-2019, integrated into UniProtKB/TrEMBL.
DT 13-FEB-2019, sequence version 1.
DT 28-JAN-2026, entry version 15.
DE SubName: Full=Terminal flower 1 {ECO:0000313|EMBL:AXF50634.1};
GN Name=TFL1 {ECO:0000313|EMBL:AXF50634.1};
OS Rubus idaeus (Raspberry).
OC Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
OC Spermatophyta; Magnoliopsida; eudicotyledons; Gunneridae; Pentapetalae;
OC rosids; fabids; Rosales; Rosaceae; Rosoideae; Rosoideae incertae sedis;
OC Rubus.
OX NCBI_TaxID=32247 {ECO:0000313|EMBL:AXF50634.1};
RN [1] {ECO:0000313|EMBL:AXF50634.1}
RP NUCLEOTIDE SEQUENCE.
RA Contreras E., Gambardella M., Pino M.T.;
RT "Sequence and expression of RiTFL1 in raspberry homolog of TFL1.";
RL Submitted (MAY-2017) to the EMBL/GenBank/DDBJ databases.
CC -!- SIMILARITY: Belongs to the phosphatidylethanolamine-binding protein
CC family. {ECO:0000256|ARBA:ARBA00007091}.
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DR EMBL; MF156853; AXF50634.1; -; mRNA.
DR EMBL; MF156854; AXF50635.1; -; mRNA.
DR AlphaFoldDB; A0A3G1RQ92; -.
DR GO; GO:0005737; C:cytoplasm; IEA:TreeGrafter.
DR GO; GO:0005634; C:nucleus; IEA:TreeGrafter.
DR GO; GO:0009910; P:negative regulation of flower development; IEA:TreeGrafter.
DR GO; GO:0010228; P:vegetative to reproductive phase transition of meristem; IEA:TreeGrafter.
DR CDD; cd00866; PEBP_euk; 1.
DR FunFam; 3.90.280.10:FF:000001; Terminal flower 1; 1.
DR Gene3D; 3.90.280.10; PEBP-like; 1.
DR InterPro; IPR008914; PEBP.
DR InterPro; IPR036610; PEBP-like_sf.
DR InterPro; IPR035810; PEBP_euk.
DR InterPro; IPR001858; Phosphatidylethanolamine-bd_CS.
DR PANTHER; PTHR11362; PHOSPHATIDYLETHANOLAMINE-BINDING PROTEIN; 1.
DR PANTHER; PTHR11362:SF13; PROTEIN TERMINAL FLOWER 1; 1.
DR Pfam; PF01161; PBP; 1.
DR SUPFAM; SSF49777; PEBP-like; 1.
DR PROSITE; PS01220; PBP; 1.
PE 2: Evidence at transcript level;
SQ SEQUENCE 172 AA; 19396 MW; 3DFC734863002ACC CRC64;
Query Match 99.7%; Score 869; Length 172;
Best Local Similarity 97.1%;
Matches 167; Conservative 0; Mismatches 5; Indels 0; Gaps 0;
Qy 1 MARMSEPLVVGRVIGDVLDSFTPTTKMIVTYTTRHVSNGYELLPSAVTTKPRVEIQGGDM 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MARMSEPLVVGRVIGDVLDSFTPTTKMIVTYTTRHVSNGYELLPSAVTTKPRVEIQGGDM 60
Qy 61 RSFFTLVMTDPDXPGPSDPYLKEHLHWVVTDIPGTTDATFGREVVSYEMPRXNIGIHRFV 120
|||||||||||| |||||||||||||||||||||||||||||||||||||| ||||||||
Db 61 RSFFTLVMTDPDAPGPSDPYLKEHLHWVVTDIPGTTDATFGREVVSYEMPRPNIGIHRFV 120
Qy 121 FVLFRQKRRQSVNPPXSRDXFNTRSFAAENDLGLPVAAVYFNXQRETAARRR 172
||||||||||||||| ||| |||||||||||||||||||||| |||||||||
Db 121 FVLFRQKRRQSVNPPSSRDHFNTRSFAAENDLGLPVAAVYFNAQRETAARRR 172
Accordingly, the structural sequence-identity limitations are taught or suggested by the combination of Chawla et al. and Contreras et al. teachings.
Neither Chawla et al. nor Contreras et al. teach Rosaceae plants such as cherry, plum, or peach.
Kurokura et al. teach regulation of flowering time in Rosaceae plant species by regulating expression of endogenous TFL1 genes in species including cherry, plum, and peach. Kurokura et al. further teach that tfl1 mutant plants flower early and exhibit a determinate inflorescence compared to wild type plants, and that TFL1 functions as a major repressor of flowering in Rosaceae plant species. The limitation requiring application to additional Rosaceae species, including stone fruits, is therefore taught or suggested by Kurokura et al. See in particular, abstract; Figures 1-2; right column at page 4134 through left column at page 4135.
Under KSR v. Teleflex, obviousness is established where prior art elements are combined according to their known functions with a reasonable expectation of success. In the instant case, Chawla et al. identify TFL1 as a regulator of flowering and teach modifying endogenous TFL genes in a Rosaceae plant. Kurokura et al. further teach that the same gene performs a conserved role across multiple Rosaceae species, while Contreras et al. demonstrate high sequence identity among TFL proteins. These teachings collectively provide a clear motivation to apply known TFL1 modification strategies across Rosaceae species.
The primary references (Chawla et al. nor Contreras) do not expressly teach every recited Rosaceae plant. In particular, Chawla et al. teach Fragaria and Contreras et al. teach Rubus, but neither reference expressly teaches cherry, plum, or peach. Kurokura et al. cure this deficiency by teaching that endogenous TFL1 genes regulate flowering in those specific Rosaceae species. Given the conserved biological function of TFL1, it would have been obvious for a person of ordinary skill in the art prior to earliest filing date of the instantly claimed invention to have been motivated to extend the modification of TFL1 genes to these additional Rosaceae species with a reasonable expectation of success.
The requirement of a Rosaceae plant comprising a mutation in an endogenous TFL gene is directly taught by Chawla et al., which disclose multiple mutagenesis approaches capable of generating mutations within the endogenous gene. The requirement that the gene encodes a TFL polypeptide is also explicitly taught through the disclosed coding and protein sequences. The requirement for sequence identity is supported by Contreras et al., which demonstrate identity exceeding the claimed threshold, rendering such similarity predictable across species.
The recited mutation types, including substitution, insertion, and deletion, are inherent outcomes of the mutagenesis methods disclosed by Chawla et al. These techniques are well known to produce a range of mutation types without requiring inventive effort. The recited deletion sizes (e.g. 1 bp to 100 bp, see claim 6) similarly represent expected variation arising from known gene editing and mutagenesis approaches, including CRISPR/Cas systems, which routinely generate deletions of varying lengths.
The requirement that the mutation results in a truncated or absent TFL polypeptide is an expected consequence of gene disruption or suppression. Chawla et al. teach reducing or eliminating expression of TFL1, which obviously (naturally flow, emphasis added) results in reduced, truncated, or undetectable protein products. The recited phenotypic traits, including reduced time to flowering, extended flowering duration, determinate growth, and improved yield, are directly taught by Chawla et al. and Kurokura et al. as consequences of reduced TFL1 function.
The recitation of specific Rosaceae species, including caneberries and stone fruits, is supported by the combined teachings. Chawla et al. establish the modification strategy within Rosaceae, Contreras et al. demonstrate sequence conservation in Rubus, and Kurokura et al. extend the functional role of TFL1 to cherry, plum, and peach. Applying the same modification across these species represents a predictable use of prior art elements according to their established biological function.
Finally, regeneration of a plant from a modified plant part is a routine and well-established practice in plant biotechnology. Once a plant cell or tissue is genetically modified, regeneration into a whole plant is a standard step that does not require inventive skill. The claimed subject matter therefore represents the predictable application of known techniques to a conserved genetic target, yielding expected results consistent with the teachings of the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
9. Claims 1, 3, 6, 8, 14, 15, and 36 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 11-32, 56, 61, and 62 of copending U.S. Patent Application No. 19/520,978 (“the ’978 application”).
Although the conflicting claims are not identical, they are not patentably distinct because the products claimed in the copending ’978 application encompass the products presently claimed. Specifically, the raspberry plant or plant part of the copending ’978 application, representing a species within the instant claimed genus Rosaceae, anticipates the instant claims directed to a Rosaceae plant or plant part comprising one or more endogenous mutations in the TFL1 gene.
The TFL1 gene of the copending ’978 application comprises a nucleic acid sequence set forth in SEQ ID NOs: 69, 77, or 80, each having greater than 80% identity to the instant SEQ ID NO: 214, and encoding a polypeptide set forth in SEQ ID NO: 71, which has greater than 80% identity (at least 99.7%) to the instant SEQ ID NO: 216. In addition, the copending ’978 application discloses SEQ ID NOs: 83, 84, 85, 86, 89, and 90, each having at least 98.4% identity to the instant SEQ ID NO: 224. Furthermore, SEQ ID NO: 71 of the copending ’978 application is 100% identical to the instant SEQ ID NO: 272.
Accordingly, the TFL1 mutation(s) and the resulting phenotypic characteristics recited in the instant claims are encompassed by the plants or plant parts claimed in the copending ’978 application. Therefore, the instant claims are not patentably distinct from the claims of the copending ’978 application.
This is a provisional non-statutory obviousness-type double patenting because conflicting claims of copending ‘978 have not been patented.
Conclusion
10. Claims 1, 3, 6, 8, 14, 15 and 36 are rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. 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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/VINOD KUMAR/ Primary Examiner, Art Unit 1663
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