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 .
Election/Restriction
In the response received on Feb. 17, 2026, Applicant affirms the election of the invention of Group I (claims 1-7) and the species of SEQ ID NO: 43 and SEQ ID NO: 126 (Resp 6). Applicant states that the election is made “with traverse” (Id.), however, no arguments or grounds of traversal were presented. The restriction requirement for lack of unity is maintained. Applicant is reminded that unity of invention will be re-evaluated at each step of prosecution, and when a claim is found to be allowable, than all claims that require all of the limitations of the special technical feature in the allowable claim will be rejoined because they will share unity of invention.
Claims 19 and 20 have been newly added and claim 4 has been canceled. Claims 1-3 and 5-20 are pending, claims 8-18 are withdrawn for being directed to non-elected inventions, and claims 1-3, 5-7, 19, and 20 are examined in this Office Action.
Objections and Rejections That Are Withdrawn
The objections to claims 2 and 7 are withdrawn in light of Applicant’s amendments to the claims.
The rejection of claim 1 for reciting an improper Markush group is withdrawn in light of Applicant’s amendments to the claims along with their arguments which were found to be persuasive (Resp 7). Applicant has amended the claim to be limited to amino acid sequences of proteins that each bind to M. incognita’s effector protein #8.
The rejection of claim 3 for reciting an improper Markush group is withdrawn in light of Applicant’s amendments to the claims.
The portion of the indefiniteness rejection of claim 1 directed to being unclear if the recited sequences were for before or after the gene having had its expression altered. Applicant’s amendment to claim 1 make it clear that the sequence is for before the change in expression.
The portions of the indefiniteness rejection of claim 2 for a lack of antecedent basis for “the endogenous promoter” and for “heterologous nucleic acid” in part ii) are withdrawn in light of Applicant’s amendments to the claims. The portions of the indefiniteness rejection over claim 2 part “vii)” are moot in light of Applicant’s deletion of this part of the claim. The portion of the indefiniteness rejection for lack of antecedent basis for “the plant” in part vi) is withdrawn in light of Applicant’s amendments to the claims.
The portion of the indefiniteness rejection of claim 3 for whether the protein that is unable to interact is the protein before or after mutations is withdrawn in light of Applicant’s amendments to the claims. The Examiner interprets this recitation to encompass a deleted or completely silenced gene because if no protein is made, then it necessarily means that no protein is interacting with any effector.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
Claim 1 was amended to insert “gene prior to being” immediately before a list of choices for modifying the gene expression, however, in the next line “gene” appears between “inactivated” and “comprises”, and this is redundant because of the newly added “gene” rendering the claim grammatically incorrect.
Claim 2 recites “a exogenous nucleic acid”, and the article should be replaced with - - an - - because “exogenous” begins with a vowel.
Appropriate correction is requested.
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.
Indefiniteness
Claims 1-3, 5-7, 19, and 20 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. Applicant’s arguments in the response received on Feb. 17, 2026, have been fully considered but were not found to be persuasive.
The claims are directed to a plant cell comprising one or more underexpressed, overexpressed, silenced, inactivated, or overexpressed and inactivated gene, wherein the gene prior to being underexpressed, overexpressed, silenced, inactivated, or overexpressed and inactivates comprises a nucleic acid sequence encoding a protein selected from SEQ ID NOs: 2, 3, 9, 10, 13, 15, 16, 25, 28, 30, 31, 38, 39, 42, 43, 44, 54, 55, 56, 62, 66, 82, 83, 84, 85, 88, 89, 93, 96, 104, 105, 106, 107, 108, 116, 118 and homologs thereof (claims 1, 19, and 20); including wherein the plant cell comprises the endogenous promoter with one or more mutations, a heterologous nucleic acid comprising the gene, an inhibitory oligonucleotide that reduces, silences, or abolishes the expression of the gene, a deletion of the gene, or the gene is integrated into the germplasm of the plant cell or the plant (claim 2); including wherein the protein encoded by the gene cannot interact with one or more root-knot nematode (RKN) effector proteins of SEQ ID NO: 126 or a homolog thereof (claim 3); including wherein the cell is in a plant part (claim 5) or a root (claim 6), and including wherein the plant is a tomato plant or other RKN-host plant (claim 7).
The terms “underexpressed”, “overexpressed”, “inactivated” in claim 1 are relative terms which render the claim indefinite. These terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Without a designated control plant cell to provide a baseline level of expression or activity, it is not possible to know what expression level or specific activity would be considered underexpressed, overexpressed, or inactivated.
Applicant argues that the specification teaches that expression levels were determined in infected and non-infected tissues and the infected were compared with the non-infected (Resp 7). This is not persuasive, however, because the claims do not include this limitation. It is improper for the Examiner to read limitations from the specification into the claims. The claims are required to recite these limitations directly.
Claims 1 and 3 each recite “or homologs thereof, and this renders the claims indefinite because it is unclear what would be necessary to be considered a homolog of one of the recited sequences. The elected protein sequence (SEQ ID NO: 43) encodes a 9-transmembrane superfamily (TM9SF) protein that was shown to interact with root knot nematode effector proteins. The TM9SF is better characterized in animals compared with plants, and there are multiple family members in each organism/species. Does “homolog thereof” encompass any TM9SF family member? Or does it encompass any protein that binds the same effector protein? Or does it need a particular percent sequence identity to the recited amino acid sequences? Or does it need to have particular domains or motifs within the protein? The metes and bounds of “homologs thereof” is completely unclear.
For claim 3, the same issue exists for “homologs” of the recited list of RKN effector proteins. Is any RKN effector protein a homolog? Is any pathogen effector protein a homolog? Is homolog defined by a particular percent sequence identity to the recited amino acid sequences? Or does it need to have particular domains or motifs within the protein?
Applicant argues that the specification provides a definition of “homologs of nucleic acid sequences by teaching that such homologs will be understood to mean any nucleotide sequence obtained by mutagenesis and exhibiting modifications in relation to the parent sequences. Applicant asserts that examples of such “homologs” are provided in the specification (Resp 8). This is not persuasive, however, because the specification only provides examples, it does not provide a definition. For example, the specification states: “In various embodiments, “homologs” of nucleic acid sequences have substantially the same biological activity as the corresponding reference gene, i.e., a gene homologous to a native gene would encode for a protein having the same biological activity as the corresponding protein encoded by the naturally occurring gene.” (Spec 9). This is exemplary rather than a definition. Furthermore, it is unclear what is required for having “substantially the same biological activity”.
Claim 2 parts iii) and iv) recite “significantly reduces”, and it is unclear what is meant by “significantly”. How much reduction is required to be considered “significant”? Also what is the reduction relative to? What is the control expression that is not reduced?
Applicant argues that the specification provides a definition on page 9 (Resp 8). This is not persuasive, however, because the definition on page 9 in the specification comprises broad and narrow together “at least (or at least about)”, and “non-genetically modified plant from which the genetically modified plant was derived (e.g., a tomato plant)”, and “can range from about 30% to about 99.99% about 40% to about 99.99% … … or are devoid of expression …”. This does not provide clarity around the metes and bounds of the term “significantly reduces”.
Claim 2 recites the limitation "the endogenous gene" in part v). There is insufficient antecedent basis for this limitation in the claim. There has been no previous recitation of any endogenous gene.
Applicant did not address this particular ground of indefiniteness.
Claim 2 part vi) recites “integrated into the germplasm of the plant cell”, and this is confusing. The definition of “germplasm” is “seeds, or plant or animal tissues, that are kept for the genetic material they contain and used in breeding programs and for research.” (Cambridge Dictionary; downloaded from https://dictionary.cambridge.org/us/dictionary/english/germplasm on Nov. 12, 2025; pp. 1-7). It is unclear what is meant by having a gene integrated into the germplasm of a plant cell. If Applicant intends to be covering having the gene integrated into the nuclear genome or into the mitochondrial or chloroplast genome, then they are advised to amend the claim accordingly.
Applicant argues that there is an alternative definition for “germplasm” in Merriam-Webster dictionary, and the alternative definition means “germ cells and their precursors serving as the bearers of heredity and the genetic material of germ cells” Resp 8). This is not persuasive, however, because given the fact that there are multiple different definitions in the art that each have a different scope, and given that the originally filed specification did not include a definition, it is unclear what the metes and bounds of “germplasm” are in the instant claim.
Claim 2 part viii) appears to be missing some words: “the overexpressed gene under an endogenous promoter and/or an exogenous promoter” is unclear.
Applicant did not address this particular ground of indefiniteness.
Claim 5 is confusing because it is unclear if the claim is directed to a plant cell or if the claim is directed to a plant part comprising the specified plant cell.
Claim 6 is confusing because it is unclear if the claim is directed to a plant cell or if the claim is directed to a plant root comprising the specified plant cell.
Applicant argues that the recitation in claim 5 would be understood to be directed to a plant part as compared to in a whole plant, and claim six clarifies that the plant part is a root (Resp 9). This is not persuasive, however, because it does not address the foundational problem. The claims each start with “The plant cell”, and this makes it sound as if the claim is directed to a plant cell. The claim is followed by a location for the plant cell. As an analogy, if an invention were a bicycle, and there is a dependent claim to “said bicycle, wherein said bicycle is in a metal box”, is the claim directed to a bicycle? Or is the claim directed to a metal box comprising the bicycle?
Lack of Enablement
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.
Claims 1-3, 5-7, 19, and 20 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 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 claims are broadly drawn to a plant cell comprising one or more underexpressed, overexpressed, silenced, inactivated, or overexpressed and inactivated gene, wherein the gene prior to being underexpressed, overexpressed, silenced, inactivated, or overexpressed and inactivates comprises a nucleic acid sequence encoding a protein selected from SEQ ID NOs: 2, 3, 9, 10, 13, 15, 16, 25, 28, 30, 31, 38, 39, 42, 43, 44, 54, 55, 56, 62, 66, 82, 83, 84, 85, 88, 89, 93, 96, 104, 105, 106, 107, 108, 116, 118 and homologs thereof (claims 1, 19, and 20); including wherein the plant cell comprises the endogenous promoter with one or more mutations, a heterologous nucleic acid comprising the gene, an inhibitory oligonucleotide that reduces, silences, or abolishes the expression of the gene, a deletion of the gene, or the gene is integrated into the germplasm of the plant cell or the plant (claim 2); including wherein the protein encoded by the gene cannot interact with one or more root-knot nematode (RKN) effector proteins of SEQ ID NO: 126 or a homolog thereof (claim 3); including wherein the cell is in a plant part (claim 5) or a root (claim 6), and including wherein the plant is a tomato plant or other RKN-host plant (claim 7).
Applicant teaches the protein of SEQ ID NO:43 is Solyc04g014570.3 which is a native tomato protein (Spec 19, Table 1). Applicant teaches the RKN effector protein of SEQ ID NO: 126 is Effector #8 “Minc00469” (Spec 36, Table 2). Applicant teaches that the protein of SEQ ID NO: 43 interacts with Effector #8 “Minc00469” and Effector #7 “Minc00344” (Spec 129-131, Table 4). Applicant teaches an increase in expression of the wild type gene encoding SEQ ID NO: 43 in adjacent root tissues at 4 days post inoculation (dpi) with Meloidogyne incognita which is the pathogen that causes Root Knot (Spec 132-133, Table 5).
Applicant identified a tobacco homolog of the elected tomato protein (SEQ ID NO: 43), and determined that it is also targeted by effectors from Phytophthora infestans (Spec 137). Applicant discloses that in the art, mutants of genes encoding host proteins repeatedly targeted by multiple effectors from different pathogens generally exhibit disease phenotypes (137).
Applicant generated virus-induced gene silencing (VIGS) constructs, one of which targeted the elected gene encoding SEQ ID NO: 43, and identified the nucleotide sequence of the gene to be SEQ ID NO: 172 (138). The VIGS construct utilized nucleotides 18-358 of SEQ ID NO: 172 (138). Applicant teaches that silencing the elected gene increased plant susceptibility to M. incognita (139).
Applicant did not teach how to use a tomato plant that is more susceptible to Root Knot Nematodes.
One of skill in the art would not find a use for such a susceptible plant, and therefore, the claimed plant cells are not enabling for how to use the claimed invention.
Applicant argues that a plant cell that is more susceptible to RKN is suited to be used in the method because such plant cell allows the identification of genes that robustly induce RKN resistance (Resp 9-10). This is not persuasive, however, because the instant application does not provide any working examples of how a plant cell that is more susceptible to RKN can be used to identify genes that robustly induce RKN resistance. There is no guidance directed to this type of experimentation. Such experimentation would amount to a “fishing expedition”, and without any guidance and with zero working examples, this is not an enabled use.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, 5-7, 19, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiroguchi, A. (Doctoral Thesis; Hokkaido University (2021) Issued on June 30, 2021; pp. 1-66), taken with the evidence of Teixeira et al. (New Phytologist (2016) Vol. 211; pp. 276-287).
The claims are drawn to a plant cell comprising one or more underexpressed, overexpressed, silenced, inactivated, or overexpressed and inactivated gene, wherein the gene prior to being underexpressed, overexpressed, silenced, inactivated, or overexpressed and inactivates comprises a nucleic acid sequence encoding a protein selected from SEQ ID NOs: 2, 3, 9, 10, 13, 15, 16, 25, 28, 30, 31, 38, 39, 42, 43, 44, 54, 55, 56, 62, 66, 82, 83, 84, 85, 88, 89, 93, 96, 104, 105, 106, 107, 108, 116, 118 and homologs thereof (claims 1, 19, and 20); including wherein the plant cell comprises the endogenous promoter with one or more mutations, a heterologous nucleic acid comprising the gene, an inhibitory oligonucleotide that reduces, silences, or abolishes the expression of the gene, a deletion of the gene, or the gene is integrated into the germplasm of the plant cell or the plant (claim 2); including wherein the protein encoded by the gene cannot interact with one or more root-knot nematode (RKN) effector proteins of SEQ ID NO: 126 or a homolog thereof (claim 3); including wherein the cell is in a plant part (claim 5) or a root (claim 6), and including wherein the plant is a tomato plant or other RKN-host plant (claim 7). Applicant elected the protein of SEQ ID NO: 43 which is a transmembrane 9 superfamily (TM9SF) protein, and the application elected inactivation for examination.
Hiroguchi teaches a transmembrane nine protein from Arabidopsis referred to as AtTMN1 (Hiroguchi 10-11). This is a homolog of the instant SEQ ID NO: 43. Hiroguchi teaches loss of function of AtTMN1 in tmn1 mutant plants (Id. 11). Loss of function necessarily means a form of inactivation. Horiguchi teach mutant no. 10 (tmn1-1) which has a non-sense mutation in the 10th exon which results in W355stop (Horiguchi 24). Horiguchi teaches mutant no. 45 (tmn1-2) which carries a mutation in the 5’ splice donor site in the fifth intron, and tmn1-3 which carries a T-DNA insertion in the 8th intron of AtTMN1 (Id.). Horiguchi teaches that no transcripts were detected in the T-DNA insertion mutant (Id. 25). This indicates that no protein was produced in this mutant, and it necessarily means that no protein is interacting with any effector.
With regard to claim 2, the mutant tmn1 gene is the endogenous gene in the Arabidopsis plant, therefore, it is integrated into the genome of the plant.
With regard to claims 5 and 6, Hiroguchi teaches that loss of function of AtTMN1 partially relieved inhibition in root elongation under severely low boron conditions (Hiroguchi 11). This demonstrates the tmn1 mutant gene was in cells in the roots.
With regard to claim 7, Arabidopsis is a RKN host plant (Teixeira 276, summary).
Applicant argues that relying on the silence in the prior art reference implying no interaction with RKN effectors is an improper reliance on inherency for an anticipation rejection (Resp 10-11). The only claim this applies to is claim 3, and Applicant’s amendments and arguments clarified that the protein that does not interact with the RKN effector is the protein after the gene has been overexpressed and inactivated, inactivated, silenced, or underexpressed (see discussion of what this particular ground of indefiniteness was withdrawn, above, in the paragraph bridging pages 3-4 of this Office Action). If the gene has been silenced such that no transcript is made and no protein is made, then it necessarily means that no protein is interacting with an RKN effector.
Applicant argues that Hiroguchi does not anticipate claim 1 because Hiroguchi does not disclose any nucleic acid encoding one of the proteins recited in claim 1 (Resp 11). This is not persuasive, however, because the TMN1 protein taught by Hiroguchi is a member of the TM9SF family and is therefore a homolog of the elected protein of SEQ ID NO: 43.
Applicant argues that homologs of nucleic acid sequences are defined in the instant application as any nucleotide sequence obtained by mutagenesis according to techniques well known to persons skilled in the art and exhibiting modifications in relation to the parent sequences (Id.). Applicant argues that the protein taught by Hiroguchi is not a homolog according to this definition (Id.). This is not persuasive, however, because the specification does not actually define homologs in this way, rather that is one example of what a homolog could be (see indefiniteness rejection, above).
Applicant argues that they can be their own lexicographer (Id.). The Examiner agrees that any Applicant is allowed to be their own lexicographer so long as their specification provides a clear definition. In the instant application, this is not the case. There is not a clear definition, but instead there are several examples. Focusing on one of these examples cannot overcome an art accepted meaning for a term in the art, because an example is not the same thing as a definition.
Claim Rejections - 35 USC § 102/103
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.
Claim(s) 1-3 and 5-7 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Menda et al. (The Plant Journal (2004) Vol. 38; pp. 861-872).
The claims are drawn to a plant cell comprising one or more underexpressed, overexpressed, silenced, inactivated, or overexpressed and inactivated gene, wherein the gene prior to being underexpressed, overexpressed, silenced, inactivated, or overexpressed and inactivates comprises a nucleic acid sequence encoding a protein selected from SEQ ID NOs: 2, 3, 9, 10, 13, 15, 16, 25, 28, 30, 31, 38, 39, 42, 43, 44, 54, 55, 56, 62, 66, 82, 83, 84, 85, 88, 89, 93, 96, 104, 105, 106, 107, 108, 116, 118 and homologs thereof (claims 1, 19, and 20); including wherein the plant cell comprises the endogenous promoter with one or more mutations, a heterologous nucleic acid comprising the gene, an inhibitory oligonucleotide that reduces, silences, or abolishes the expression of the gene, a deletion of the gene, or the gene is integrated into the germplasm of the plant cell or the plant (claim 2); including wherein the protein encoded by the gene cannot interact with one or more root-knot nematode (RKN) effector proteins of SEQ ID NO: 126 or a homolog thereof (claim 3); including wherein the cell is in a plant part (claim 5) or a root (claim 6), and including wherein the plant is a tomato plant or other RKN-host plant (claim 7). Applicant elected the protein of SEQ ID NO: 43 which is a transmembrane 9 superfamily (TM9SF) protein, and the application elected inactivation for examination.
As discussed, above, in the enablement rejection, the elected protein of SEQ ID NO: 43 is a native tomato protein encoded by an endogenous gene comprises SEQ ID NO: 172.
Menda teaches a saturated mutation library of tomato (Menda, title). The library of tomato mutants has 13,000 M2 families (Id. abstract). Menda teaches the creation of a mutant population using EMS mutagenesis to obtain relatively high mutation rates, coupled with fast-neutron mutagenesis (Id. 862-863). Menda teaches that other mutant populations are also available from the Solanaceae Genome Network, UC Davis, and other academic sources (Id. 862). Menda teaches that a primary objective is to generate a saturated mutant population where every locus is mutated and represented with multiple alleles (Id. 867-868).
With regard to claim 2, the mutant genes in the population taught by Menda are endogenous genes, and therefore they are integrated into the genome of the plants.
With regard to claim 3, the most common mutations are mutations that cause frame-shifts and/or introduce early stop codons in the mutated gene. A protein encoded by a truncated gene or a mis-sense mutated gene would necessarily be unable to interact with its normal binding partner.
With regard to claims 5 and 6, Menda teaches growing progeny mutants, including growing seedlings and transplanting into a field (Menda 871). This necessarily involves plants with roots, and the roots would necessarily comprise the mutated gene.
With regard to claim 7, the mutant plants taught by Menda are tomato plants.
Menda is silent about a mutation in the Solyc04g014570.3 locus, specifically, however Menda asserts their mutant population has mutations at every locus in the genome. In addition, the instant claims allow for a mutation in any homolog of the claimed gene. The preponderance of the evidence points to the conclusion that at least one tomato plant in the population of mutants taught by Menda would have had a mutation in the native gene encoding SEQ ID NO: 43 or in a native gene encoding a homolog thereof; and the preponderance of the evidence points to the conclusion that at least one of such mutants would have resulted in a loss of function.
In the event there is not even one single tomato plant in the saturated mutant population that comprises a mutation in the native gene encoding SEQ ID NO: 43 or in a native gene encoding a homolog thereof; it would have been obvious and within the scope of one of ordinary skill in the art to mutagenize more tomato plants to add to the population. One would have been motivated to do so, because Menda specifically teaches that the goal is to obtain multiple mutations in every single gene in the genome.
Applicant argues that Menda does not teach or suggest any of the nucleic acid sequences encoding the proteins recited in claim 1 (Resp 12). This is not persuasive, however, because any tomato plant would have inherently had endogenous genes encoding proteins that comprise SEQ ID NO: 43 or a homolog thereof. Applicant has identified the gene encoding SEQ ID NO: 43 as an endogenous gene at the Solyco4g014570.3 locus. All tomatoes have this locus or a locus encoding a homolog of SEQ ID NO: 43. This is true even though Menda did not specifically teach the amino acid sequences of any proteins.
Applicant argues that one skilled in the art would not have been motivated to prepare a plant cell as claimed or have a reasonable expectation to arrive at a plant cell as claimed (Id.). This is not persuasive, however, because the motivation does not need to be for the same purpose as the instant inventors as long as it arrives at the same product. One of ordinary skill in the art would have been motivated to obtain a library of mutant tomato plants with mutations throughout the entire genome for the reasons discussed, above. One of ordinary skill in the art would have had a reasonable expectation of success in obtaining mutants in all genes using an iterative process to saturate the genome because this is a routine process even though it may be labor intensive.
Applicant argues that Menda states that a “desired” characteristic of a comprehensive mutant population is a “hit” in every single gene, not that their mutant population had a mutation in every gene, and Menda states that their results were consistent with a population that is “nearly saturated”, and Menda acknowledges that earlier attempts a saturation mutagenesis in tomato did not produce a rich harvest (Resp 12). The Examiner agrees with these statements, and this is why the rejection is a rejection for anticipation or obviousness in the alternative. The USPTO does not have laboratory facilities for the Examiner to detect mutations in the Solyco4g014570.3 locus in the population of tomato plants taught by Menda. Because the Examiner is unable to do this detection, the anticipation portion of this rejection is based on the preponderance of evidence that given the large numbers of mutants generated by Menda, it is more likely than not that there is a mutation in this locus.
Applicant argues that Menda acknowledges that detecting genes that affect pathways without a visible phenotype were outside the scope of their screen and would involve novel technologies (Id.). This is not persuasive, however, because even if the mutant plant having a mutation in the Solyco4g014570.3 locus does not have a visible phenotype, if it is present in the population then it would anticipate the instant claims without having been detected.
Applicant argues that the claimed plant cell is not necessarily present in Menda, and that even if one were to mutagenize more tomato plants, there would not have been a reasonable expectation of arriving at the claimed plant cell in view of the unpredictability of effects of mutations on cell viability (Id. 13). This is not persuasive, however, because there is nothing in the record to indicate that the Solyco4g014570.3 locus comprises an essential gene which would cause a loss of viability if mutated. Even if one targets an essential gene for mutation, a plant cell that is heterozygous for the mutation would still be viable. The preponderance of the evidence suggests that a large enough population of mutant tomato plants would comprise multiple mutations in the Solyco4g014570.3 locus, and the most common result of such mutations is a loss of function.
Summary
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
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 A 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.
CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1662
Prosecution Insights