DETAILED ACTION
The present application, filed on or after 16 March 2013, is being examined under the first-inventor-to-file provisions of the AIA .
Claim status
Claims 14-29 are pending.
Claims 24 and 29 are withdrawn.
Claims 14-23 and 25-28 are examined.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 14-23 and 25-28 in the reply filed on 5/8/2026 is acknowledged.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
1) 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
a) In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
i) the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
b) In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
i) the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
c) In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
d) In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
2) When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
a) If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
b) If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
3) Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiencies – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d), in at least the following places of the disclosure:
Applicant has not provided a sequence listing file.
The sequences referred to as scaffolds, for example, in the paragraph under “genome assembly” on page 24 and in the paragraph bridging pages 24 and 25.
The sequences present in Table 3 of the Specification (pages 22-23) do not have sequence identifiers.
The sequences present in Table 4 of the Specification (pages 25-26) do not have sequence identifiers.
The sequences present in Table 5 of the Specification (page 27) do not have sequence identifiers.
The sequences present in Table 6 of the Specification (pages 27-28) do not have sequence identifiers.
The sequences present in Table 12 of the Specification (pages 34-36) do not have sequence identifiers.
The sequences necessary to identify the SNPs of Figure 11, i.e., the reference and “alternate”, or polymorphic form of each sequence comprising its upstream sequence and downstream sequence do not have sequence identifiers.
The sequences present in Figure 12 do not have sequence identifiers.
If there are sequences present in Figure 13, they do not have clear sequence identifiers.
If there are sequences present in Figure 14, they do not have clear sequence identifiers.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The specification is objected to because it does not comply with the requirements under the sequence rules, as detailed above.
The disclosure is objected to because it is not clear what the “Phenotype Score” columns of Table 2 (page 28) are representing. There is no definition of the scores 0-3 provided.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on, at least, pages 18 and 21. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure is objected to because Table 6 (page 28) has a column heading that is cutoff and cannot be read.
Appropriate correction is required.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because of the following reasons.
Figures 5, 9 and 12-14 are not clear.
Figure 5 is not clear. All text characters, including numbers, words and symbols, are unclear.
Figure 9 is not clear. The line of text between “10 healthy plants planted” and “after 5 month” [sic] is unclear.
Figure 12 is not clear. All text characters, including numbers, words and symbols, are unclear.
Figure 13 is not clear. All text characters, including numbers, words and symbols, are unclear.
Figure 14 is not clear. All text characters, including numbers, words and symbols, other than other than “A”, “B” and “C” written in large font, are unclear.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 20-21 are objected to because of the following informalities: the species names are not in italics. Claim 20 is also objected to because the species names are in parentheses. The use of the parentheses raises a potential issue as to whether the parenthetical term has the same meaning as the preceding term.
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.
Claims 14-23 and 25-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Independent claim 14 recite a cultivated tomato plant harboring a resistance gene to ToBRFV from chromosome 7. This judicial exception is not integrated into a practical application because the recitation of “cultivated” in the preamble of the claims is only an intended use without providing additional structure limiting the breadth of the claims. The structural features of the claims appear to be found in naturally occurring tomato plants. For example, claim 20 recites that the cultivated tomato plant is a wild tomato plant selected from a Markush group of naturally occurring tomato plants.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception. Claim 17 requires the plant to have a ToBRFV resistance-conferring QTL from chromosome 2 of the same plant as the source of the resistance on chromosome 7 in claim 14 (“the ToBRFV-resistant tomato plant” of claim 17 is referring to “a ToBRFV-resistant tomato plant” recited in claim 14). Therefore, this is also from a naturally occurring tomato plant. Claim 19 requires the cultivated tomato plant be the offspring of plants including two naturally occurring plants. Such crosses occur naturally.
Claim 28 recites a cultivated tomato plant comprising an introgressed locus with representative seed of the plant having been deposited. It is not clear whether a plant represented by the deposit is naturally occurring. Applicant is directed to the portions of the rejections under 35 USC 112(a) for failing to disclose a breeding history (under the written description requirement) as well for the deposit (under the enablement requirement).
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.
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.
Claims 14-23 and 25-28 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.
1. Claim 14 recites, “a partially dominant heterologous resistance gene or genes to tomato brown rugose fruit virus (ToBRFV), wherein the resistance gene or genes form part of a QTL derived from chromosome 7 of a ToBRFV-resistant tomato plant” and claim 28 recites, “comprising in its genome an introgressed locus that confers resistance to ToBRFV”. These are insufficiently defined functional limitations. These limitations represent genetic information providing resistance to tomato brown rugose fruit virus but that genetic information is not provided. This language appears to intend to limit the claims but the metes and bounds are not clear because a structure needed to accomplish the recited function is not taught. The specification fails to provide what genetic information is associated with the phenotype.
The teachings of Applicant's specification are discussed in greater detail in the rejections under 35 U.S.C. 112(a), infra. As pointed out, Applicant does not teach anything about the gene causing resistance other than putative associations with QTL on two chromosomes and an assortment of markers and phenotypes.
Applicant does not teach the sequence of the gene. Nor does Applicant provide a definitive location or presence in any particular tomato plant.
Thus, although an active gene is required, the instant claim language imposes no limits as to the structure needed for the claimed function to be performed. Further, no deposit is associated with the claims.
Applicant is reminded that while functional limitations may be properly used in claims, the boundaries imposed by a functional limitation must be clearly defined under 35 U.S.C. 112(b). Claim language that merely states a result to be obtained without providing boundaries on the claim scope is unclear. See e.g. "Enhancing Clarity By Ensuring That Claims are Definite Under 35 U.S.C. 112(b)," 20 May 2016 (available at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/examinationguidance-and-training-materials).
Claims 15-23 and 25-26 depend from claim 14 but fail to provide additional limitations to overcome the deficiency. Therefore, these claims are also indefinite. Therefore, the metes and bounds of the claims are indefinite.
2. Claim 16 recites, “the at least one marker is selected from the markers listed in Table 3”. Where possible, claims are required to be complete in themselves. Incorporation by reference to something like the referenced appendices "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
3. Claim 20 recites, “…LA0107 (S. corneliomulleri), LA0361, LA1918, LA2650 (S. habrochaites), LA1938, LA1969, LA2748, LA2755 and LA2931 (S. chilense).” The “LA” terms lack art-accepted meanings and appear to be some form of accession number prefix. Applicant does not explicitly define the terms in the specification. Furthermore, the limitations, except for the species names, appears to be essential matter to understand the scope of the claim. It is impermissible to incorporate essential matter by reference except by reference to US patent documents. The meaning of these terms could additionally change to designate something different or new during the lifetime of a patent. Thus, one's ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F .2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970). Additionally, the Markush group lists three species names, each in parentheses. It is indefinite as to whether the parenthetical term is the species of the prior listed accession or whether it is an alternative member.
4. Claim 19 recites, “[t]he cultivated tomato plant of claim 14… is the offspring of crossing a … wild tomato plant… with a … cultivated tomato plant or… wild tomato plant … with a …wild tomato plant,” emphasis added. This encompasses crossing a wild tomato plant with a wild tomato plant but the preamble specifies that the tomato plant is cultivated. Therefore, the limitations of the claim appear to claim contradict themselves making the metes and bounds of the claim indefinite.
5. Claim 20 recites, “the cultivated tomato plant of claim 14… is a wild tomato plant”. Therefore, if the tomato plant is cultivated as suggested by the preamble the limitations of the claim would contradict themselves, making the metes and bounds of the claim indefinite.
6. Claims 25-27 recite, “plant source 1441”. The claims are indefinite for their recitation of “plant source 1441” because this name is not recognized in the art and alone does not clearly identify the plant and thus does not set forth the metes and bounds of the claimed invention. The name of “plant source 1441” does not carry any art recognized limitations with respect to any specific characteristics. Moreover, the name appears to be arbitrarily assigned and any specific characteristics associated therewith could be modified, as there is no written description of the plant that encompasses all of its traits. Amending the claims 1, 4, and 18 to recite an accession deposit number for the plant with a proper statement of deposit would obviate this rejection.
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.
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 14-23 and 25-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims require a tomato plant with one or more partially dominant, heterologous, resistance genes to ToBRFV which is part of a QTL from chromosome 7 of a ToBRFV-resistant tomato plant. Dependent claims specify at least one marker be present with limitations on the genomic region within multiple megabase pairs, i.e., within a sequence of >1,0000,000 base pairs. Additional limitations include an additional ToBRFV-resistant QTL from chromosome 2. The claims thus encompass a large genera of tomato plants, resistance genes and markers.
Applicant describes additive QTLs associated with resistance to ToBRFV on chromosome 2 and chromosome 7 of tomato (Table 2, page 20). It is noted that there is no definition provided for each phenotype score, but it is interpreted by the examiner as 0 being susceptible and 1-3 are resistant.
Applicant describes identification of three scaffolds in “1441”, which is a S. lycopersicum source of ToBRFV resistance. Applicant describes these scaffolds are on chromosome 2 (page 25). Applicant describes the resistance as being dominantly inherited (Example 5).
The described embodiments are not representative of the breadth of the claimed genus such that one of ordinary skill in the art would be able to envision which members of the claimed genus possess the claimed function. Further, Applicant has not provided a structure that would provide the function of ToBRFV resistance. Applicant does not teach identification of a gene that confers ToBRFV. It appears that a plant having a part of, or all of, the QTL from chromosome 7, with or without the QTL from chromosome 2, would not be recognized by one of ordinary skill in the art as conferring resistance to ToBRFV in tomato. For example, it appears from Table 2 of the disclosure that most plants with both QTLs were still susceptible to ToBRFV. Additionally, the knowledge in the art shows that ToBRFV resistance associated with a chromosome 7 QTL is background-dependent (Rochsar et al. BMC plant Biology. 25:51. 2025; Last sentence of the Results subsection of the Abstract and the Conclusion subsection of the Abstract). Further, Applicant has not described partially dominant ToBRFV resistance. Therefore, given the breadth of the genera encompassed by the claims, the described species are not sufficiently representative.
Therefore, Applicant fails to satisfy the written description requirement.
Missing Breeding History
Claims 14-23 and 25-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
MPEP 2163 (I) states:
The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").
MPEP 2163(I) states:
“The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
In the instant application, a full examination cannot be conducted. Applicant claims a novel lettuce plants which are offspring of crossing ToBRFV-resistance cultivated tomato plant source 1441 with a hybrid ToBRFV-resistant cultivated tomato plant. A novel plant is defined by both its genetics (breeding history) and its traits. In the instant application, Applicant has provided a description of the plant traits. Applicant provides breeding diagrams for screening for QTLs starting from 1441 but does not disclose the parents of 1441. The instant application is thus incomplete as to the breeding history used to produce the claimed plants.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (USDA, “Applying for a Plant Variety Certificate of Protection”, https://www.ams.usda.gov/services/pvpo/application-help/apply, accessed 1 May 2023). Additionally, the International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV, 2017, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, see notes 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen, Board Decision in Application 14/996,093, 2020). In both of these cases, there were many differences cited by the applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
Moreover, a specification an incomplete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotype of the claimed plant for assessing potential infringement.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. The assumption that elite cultivars are composed of relatively homogenous genetic pools is false (Haun et al, 2011, Plant Physiol. 155:645-655; see pg 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (pg 645, right column, paragraph 2, to pg 646, left column, paragraph 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al, 2015, J. Exp. Bot. 66:5429-5440; see pg 5430 left column, paragraph 2, and right column, paragraph 2). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification to identify all names for all parental lines utilized in the development of 1441. Applicant provides that resistant sources were identified from accessions obtained of Solanum species but does not indicate which was used to introgress resistance to the Solanum lycopersicum plant designated “1441”. If Applicant’s breeding history uses proprietary line names, Applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If either of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line(s) as well (i.e., grandparents).
Applicant is also reminded of the duty to disclose information material to patentability. Applicant should also notate the most similar plants, which should include any other plants created using similar breeding history (such as siblings of the instant variety).
This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
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 14-23 and 25-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims require a tomato plant with one or more partially dominant, heterologous, resistance genes to ToBRFV which is part of a QTL from chromosome 7 of a ToBRFV-resistant tomato plant. Dependent claims specify at least one marker be present with limitations on the genomic region within multiple megabase pairs, i.e., within a sequence of >1,0000,000 base pairs. Additional limitations include an additional ToBRFV-resistant QTL from chromosome 2. The claims thus encompass a large genera of tomato plants, resistance genes and markers.
Applicant teaches additive QTLs associated with resistance to ToBRFV on chromosome 2 and chromosome 7 of tomato (Table 2, page 20). It is noted that there is no definition provided for each phenotype score, but it is interpreted by the examiner as 0 being susceptible and 1-3 are resistant.
Applicant teaches identification of three scaffolds in “1441”, which is a S. lycopersicum source of ToBRFV resistance. Applicant teaches these scaffolds are on chromosome 2 (page 25). Applicant teaches the resistance as being dominantly inherited (Example 5).
The lack of predictability in the art and the lack of guidance provided by Applicant would not have enabled one of ordinary skill in the art to make and use the full scope of the claimed invention. Applicant does not teach a gene that confers ToBRFV. It appears that a plant having a part of, or all of, the QTL from chromosome 7, with or without the QTL from chromosome 2, would not be recognized by one of ordinary skill in the art as conferring resistance to ToBRFV in tomato. For example, it appears from Table 2 of the disclosure that most plants with both QTLs were still susceptible to ToBRFV. Additionally, there is not enough known in the prior art to make and use the full scope of the claimed invention. Rochsar et al. provides that ToBRFV resistance associated with a chromosome 7 QTL is background-dependent (Rochsar et al. BMC plant Biology. 25:51. 2025; Last sentence of the Results subsection of the Abstract and the Conclusion subsection of the Abstract).
Therefore, Applicant fails to satisfy the enablement requirement.
Deposit of Biological Material
Claims 14-23 and 25-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention requires novel plants including deposited seeds. For example, claim 20 is drawn to nine accessions of three species from the Solanum genus of plants. The specification refers to a deposit on page 6, and claims the deposit in claim 28. The source of resistance included in claim 14 appears to require resistance from seed that is represented by the deposit. Therefore, the claims all require seed of the deposited plant.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public.
The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
It is noted that Applicant states that seeds for a lettuce plant are deposited at the NCIMB (page 6) but Applicant has not provided several requirements regarding the deposit. It is thus not clear that the seeds have actually been deposited. Additionally, it is not clear what names Applicant is referring to this deposit by in the disclosure.
If the deposit of these seeds is made and accepted under the terms of the Budapest Treaty, then that and a statement of that by an attorney of record over his or her signature and registration number would satisfy the deposit requirement made herein.
If the deposit is not made and accepted under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Closest prior art
The closest prior art is US2020/0077614, which teaches ToBRFV resistance in tomato from chromosome 2 but does not require resistance from chromosome 7 and additionally requires resistance from QTL chosen from the QTL on chromosome 11, the QTL on chromosome 6 and the QTL on chromosome 9.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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/DAVID R BYRNES/Examiner, Art Unit 1662
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