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 .
Status of Claims
Claims 1, 8-11, 13-17, 19-20, 27 & 31 are under examination on the merits.
Claims 3-7 & 23 are withdrawn.
The objection to the specification is withdrawn in light of Applicant’s amendments.
The objections to claims 9-10, 14 & 27 are withdrawn in light of Applicant’s amendments.
The rejection of claims 8-10 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, are withdrawn in light of Applicant’s amendments.
The rejection of claims 1, 8-11, 13-17, 19-20 & 27 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of the acceptance of LVSTBRFVRES2 NCIMB accession number 43591 at NCIMB under the Budapest Treaty and the filed declaration that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
The rejection of claims 1, 8-11, 17, 19 & 20 under 35 U.S.C. 103 as being unpatentable over Allersma et al (US 2020/0048655 A1) in view of Kang et al (2005) Annu. Rev. Phytopathol. 43:581–621 is withdrawn in light of Applicant’s amendments.
The rejection of claims 1, 8-11, 14-17, 19 & 20 under 35 U.S.C. 103 as being unpatentable over Allersma in view of Kang and further in view of Ashkenazi et al US 11,730,135 B2 is withdrawn in light of Applicant’s amendments.
The rejection of claims 1, 8-11, 14-17, 19 & 20 under 35 U.S.C. 103 as being unpatentable over Allersma and Kang and further in view of El-Aziz et al (2008) Egypt. J. Genet. Cytol. 37: 323-333 is withdrawn in light of Applicant’s amendments.
Claim Objections
Claims 8 & 19 are objected to because of the following informalities:
Claim 8 (lines 9-10) recites the limitation “a marker SL2.50ch11_9924232 according to SEQ ID NO: 115”. This should be amended to “the marker SL2.50ch11_9924232 according to SEQ ID NO: 115” to make it clear this is the same marker recited in claim 1 (lines 11-12).
Claim 19 (line 17) recites “allele A of a SNP TO-0201239 according to SEQ ID NO: 104”. This should be amended to “allele A of the SNP TO-0201239 according to SEQ ID NO: 104” to make clear this is the same SNP recited in claim 1 (line 14).
Claim 19 (line 6) recites “a QTL11 on chromosome 11”. The plant part etc. of claim 19 is of a plant according to claim 1, which also requires “a QTL11 on chromosome 11” (lines 2-3). If the QTL11 of claim 19 is the same QTL11 as claim 1, Claim 19 (line 6) should be amended to read “the QTL11” to make clear this is the same QTL11 as claim 1 (lines 2-3).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 10, 27 & 31 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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 3/31/2025, as applied to claims 1, 8-11, 13-17, 19-20 & 27. Applicant' s arguments filed 9/30/2025 have been fully considered but they are not persuasive.
Claim 10 (line 4) recites the limitation “the SNP TO-0201241 according to SEQ ID NO: 106”. There is insufficient antecedent basis for this limitation in the claim. A “SNP TO-0201241 according to SEQ ID NO: 106” is previously recited in claims 8 & 9 but not in claim 1 upon which claim 10 depends.
Claim 27 recites the limitation “the SNP TO-020137 according to SEQ ID NO: 102” in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation “the SNP TO-0201240 according to SEQ ID NO: 105” in lines 4-5. There is insufficient antecedent basis this limitation in the claim.
Applicant disagrees that the terms “the SNP” and “the marker” in claims 1 & 19 are unclear and lack antecedent basis. Applicant urges that a person of ordinary skill in the art would understand that the defined region on chromosome 9 extends from the positions of the polymorphisms within SEQ ID NO: 1 and 101 and the defined region on chromosome 11 extends from the positions of the polymorphisms within SEQ ID NOs: 102 and 115 in light of the definition in the specification that “a genomic region delimited by two SNPs X and Y refers to the section of the genome, more specifically of a chromosome, lying between the positions of these two SNPs and preferably comprising said SNPs, therefore the nucleotide sequence of this chromosomal region begins with the nucleotide corresponding to SNP X and ends with the nucleotide corresponding to SNP Y” (Remarks, page 11, paragraphs 2-3).
This argument is unpersuasive, because the phrase "preferably" renders it unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05. While Applicant’s amendments overcome the original rejection, “the SNP” and “the marker” vs “a SNP” and “a marker” are not used consistently with respect to antecedent basis in the amended claims, creating new issues of indefiniteness.
Applicant urges that the term SNP is defined as a single nucleotide which is variable depending on the allele which is present, so a person of ordinary skill in the art would have understood the phrase “comprises allele [X] of a SNP according to SEQ ID NO: [X]” to mean that the plant comprises the noted single nucleotide variation within the SEQ ID NO, so “SNP” and “marker” have proper antecedent basis (Remarks, page 12, paragraphs 1-2).
This argument is unpersuasive, because while Applicant’s amendments overcome the original rejection regarding the delineation of the chromosome region of claims 1 & 19, “the SNP” and “the marker” vs “a SNP” and “a marker” are not used consistently with respect to antecedent basis in the amended claims, creating new issues of indefiniteness.
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 1, 8-11, 13-17, 19-20, 27 & 31 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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 3/31/2025, as applied to claims 1, 8-11, 13-17, 19-20 & 27. Applicant' s arguments filed 9/30/2025 have been fully considered but they are not persuasive.
Claims 1, 8-11, 13-17, 19-20, 27 & 31 all require a S. lycopersicum plant comprising a quantitative trait locus on chromosome 11 introgressed from S. pimpinellifolium and conferring resistance to ToBRFV present in the genome of LVSTBRFVRES2 NCIMB accession number 43591, wherein the QTL comprises allele G of SEQ ID NO: 102, allele A of SEQ ID NO: 103, and allele A of SEQ ID NO: 104 wherein the QTL on chromosome 11 does not confer resistance to Stemphylium.
The claims require a QTL that provides resistance to ToBRFV located on chromosome 11 in a region between instant SEQ ID NO: 102 and SEQ ID NO: 115 and found in LVSTBRFVRES2 NCIMB accession number 43591.
While the claims recite a QTL providing resistance to ToBRFV, the specification does not provide the identity of a QTL on chromosome 11 demonstrated to confer plant resistance to ToBRFV. The specification instead provides 14 markers associated with the QTL on chromosome 11, include the SNPs of SEQ ID NOs: 102-104, between positions 8,744,810 and 9,924,232 on SL2.50 (table K) found in Source D LVSTBRFVRES2 NCIMB accession 43591.
QTLs on chromosome 11 providing resistance to ToBRFV are known in the art. Allersma et al (US 2020/0048655 A1, published 2/13/2020, hereafter Allersma) describes S. lycopersicum plants comprising a QTL on chromosome 11 that confers resistance to ToBRFV (table 3; paragraphs [0150-0151]). This QTL is in a region that is derived from S. pimpinellifolium and corresponds to the interval between 8,894,829 and 9,826,973 bp on chromosome 11 of the public tomato genome map version SL2.50 (paragraph [0145]), and thus overlaps with the region of the QTL11 of the instant specification (table K). Additionally, Allersma describes the resistance QTL in this region to be present in different genetic backgrounds (paragraph [0150]). However, the instant application describes the instant QTL11 as different from the QTL of Allersma because the QTL11 of the instant application does not provide resistance to Stemphylium (table L, page 58, lines 12-17). Amended claims require that the QTL on chromosome 11 does not confer resistance to Stemphylium.
Hamelink et al WO 2018/110130 A1 (published 6/13/2019, hereafter Hamelink) also describes S. lycopersicum lines with resistance to ToBRFV introgressed from S. pimpinellifolium (page 20, paragraph 2 & table 2). Hamelink describes a QTL for the resistance trait mapped to chromosome 11 (page 21, paragraph 3). Kalisvaart et al US 2023/0217884 A1 (published 7/13/2023 after the instant application, hereafter Kalisvaart, with the same Applicant as Hamelink) further describes a Solanum lycopersicum plant comprising a CCA gene which confers resistance against Tomato Brown Rugose Fruit Virus (ToBRFV) which has been introgressed from S. pimpinellifolium and which is on chromosome 11 (paragraph [0014], paragraph [0120-0121]). Kalisvaart describes two CCA genes within an introgressed region on chromosome 11 around 8.6-10.1 Mbp long contributing to ToBRFV resistance (paragraph [0125-0127]) and describes various SNPs in the coding sequence or promoter of the gene correlated with resistance (table 4). The instant specification argues that the QTL on chromosome 11 provided by Hamelink is not useful because the region where it was mapped was 55 Mb long (instant specification page 3 line 36-page 4 line 2), but the instant specification does not describe in what ways the claimed QTL11 differs from the QTL described by Hamelink and Kalisvaart and whether the QTL of Hamelink and Kalisvaart are absent from the genome of the seeds of LVSTBRFVRES2 NCIMB accession 43591.
Since the instant disclosure fails to describe the QTL on chromosome 11 that confers plant resistance to ToBRFV, and since QTL on chromosome 11 that confer plant resistant to ToBRFV and are derived from S. pimpinellifolium are highly variant, the provided markers are insufficient to describe the claimed QTL.
Hence, Applicant has not, in fact, described a QTL on chromosome 11 introgressed from S. pimpinellifolium that confers plant resistance to ToBRFV, and the specification fails to provide an adequate written description of the claimed invention. Therefore, given the lack of written description with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Applicant urges that amended claims 1, 19, and 27 clearly define the QTL on chromosome 11 because they recite a chromosomal region, specific alleles of 3 SNPs, and that the QTL does not confer resistance to Stemphylium (Remarks, pave 15, paragraph 2).
Additionally, Applicant urges that the amended claims do not encompass the QTL of Allersma, because the QTL of Allersma is located in a region flanked by markers that does not encompass the location of allele G of instant SEQ ID NO: 102, which the amended instant claims require. Applicant also urges that the QTL of Allersma confers resistance to both ToBRFV and Stemphylium present in the same genetic region, in contrast to the instantly claimed QTL11 (Remarks, page 15, paragraph 3-page 16, paragraph 1). Applicant urges that the instant QTL does not encompass the QTL11 of Hamelink because the instantly claimed QTL acts in a recessive manner unlike that of Hamelink. Applicant further urges that the QTL of Hamelink encompasses a much larger region than the region of the amended claims. Applicant urges that the Declaration states that the claimed plants do not comprise the alleles or combinations of alleles disclosed in Hamelink (Remarks, page 16, paragraphs 2- page 17, paragraph 1). Applicant provides a declaration that plant lines derived from LVSTBRFVRES2 NCIMB accession number 43591 only comprise 2 of the 9 markers described in Hamelink and these markers differ between lines (Declaration, page 8, paragraph numbered 19) and are susceptible to Stemphylium (Declaration page 9, paragraph numbered 20).
This argument is unpersuasive, because whether or not the markers associated with the instantly claimed QTL11 or QTL11 itself differs from those of the prior art, Applicant has not described structural features responsible for the resistance nor provided examples of plants comprising the QTL with the recited SNPs and markers in different genetic backgrounds. Between the positively recited alleles in the amended claims is a region of 545,285 bases. SEQ ID NO: 102 is found position 8,744,810 and SEQ ID NO: 104 is found position 9,290,095 (table K). Given the high diversity in known S. pimpinellifolium-derived QTLs on chromosome 11 conferring resistance to ToBRFV, one of ordinary skill in the art would not conclude that 3 SNPs over the range of 545Kb describes the full scope of QTL on chromosome 11 that confers resistance to ToBRFV and not Stemphylium and acts in a recessive manner. The QTL and the positively recited SNPs and markers found in LVSTBRFVRES2 NCIMB accession number 43591 could be present in other S. pimpinellifolium introgressed plants.
Furthermore, the species of origin of the QTL is not a patentably distinct limitation without different characteristics of the QTL, so the scope of the encompassed QTL may be even larger than just QTL derived from S. pimpinellifolium. Applicant has not reasonably described the full genus of encompassed QTL in the region delimited by SNP TO-0201237 and SL2.5ch11_9924232 and so Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Additionally, the fact that the encompassed region of the instantly claimed QTL is smaller than that of Hamelink would not in itself describe that the structural feature responsible for the ToBRFV resistance is different from the structural feature of a larger QTL described in the prior art.
B. Claims 1, 8-11, 13-17, 19-20, 27 & 31 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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 3/31/2025, as applied to claims 1, 8-11, 13-17, 19-20 & 27. Applicant' s arguments filed 9/30/2025 have been fully considered but they are not persuasive.
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 because applicant failed to provide the breeding history for the instantly claimed plant line. Specifically, in claims 1, 8-11, 13-17, 19-20, 27 & 31, applicant claims a plant, a cell, or a plant part comprising QTL found in seeds of LVSTBRFVRES2 NCIMB accession number 43591. A plant variety is defined by both its genetics (breeding history) and its traits. The instant specification urges that NCIMB 43591 is not a variety because most genes are not homozygous and phenotypes except for ToBRFV resistance segregates (page 17, lines 9-15). In the instant application, applicant has only provided a plant trait and a list of 14 markers as seen in the specification. The instant application is incomplete as to the breeding history used to produce the claimed plant line, as the S. pimpinellifolium parent line is referred to as “source D” (table A; page 40, lines 4-11).
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” (See “Applying for a Plant Variety Certificate of Protection” by the USDA reference to Exhibit A). 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 (See UPOV EDV Explanatory 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 were 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). 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 devoid of a 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 phenotypes of the claimed plants 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. Haun et al (2011) Plant Physiology, 155: 645–655 (published 11/29/2010, hereafter Haun) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun Page 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. (See Haun Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky et al (2015) J of Experimental Botany, 66(18): 5429–5440; page 5430 left column 1st full paragraph and right column 2nd full paragraph). 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 provide the breeding history used to develop the QTLs found in the variety or cultivar required by claims 1, 8-11, 13-17, 19-20, 27 & 31. When identifying the breeding history, applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety. For example, 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 one 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 as well (i.e. grandparents).
Applicant is also reminded that they have a 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).
Applicant urges that a breeding history is not an essential part of the description of a plant claimed in a utility patent and is not required to comply with the written description requirement under 35 U.S.C. 112(a). Applicant urges that Examiner has improperly relied on MPEP guidance for plant patents and requirements for Plant Variety Protection and International Union for the Protection of New Varieties of Plants (Remarks, page 17, paragraph 3-4).
Applicant urges that PTAB decisions for utility patents do not support the requirement to disclose breeding history of a plant to comply with written description requirement citing McGowen and Ex parte C. Applicant urges that Ex parte C states that there is no requirement to disclose additional information when a deposit has been made. Applicant urges that because Ex parte C states that the names of the parent plants of the claimed plant is only one of the factors considered in the evaluation of the description of a claimed plant, the decision does not state that such information is necessary to comply with the written description requirement (Remarks, page 18, paragraph 1).
This argument is unpersuasive, because 35 USC 112 (a) states:
(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. (emphasis added)
The law clearly states that Applicant must provide in the specification a written description of the invention. The only question is what an “adequate written description” is. This is a fact-based inquiry done by the factfinder (i.e., the examiner) when analyzing the nature of the instant invention.
The references cited in the rejection are evidence regarding that question of fact regarding what is considered when describing plants. They are not cited for legal analysis. The references cited, including USDA and UPOV, establish that in the plant variety art, a breeding history is part of the description of a plant line.
Applicant has not provided evidence saying that in the plant line art the breeding history is not considered part of the description of a plant line. Applicant has not rebutted the evidence provided in the rejection.
The Office has made a finding of fact that for the instant variety LVSTBRFVRES2 NCIMB accession number 43591 the minimum description is the combination of the phenotype and genotype (breeding history). To support this finding of fact, the Office has cited other plant-related intellectual property organizations and relevant court cases dealing with plant varieties in which both the phenotype and genotype are analyzed. The Office did not cite these findings to clarify the law. They are solely to clarify the finding of fact, i.e., what is an adequate written description for the instant plant variety. Applicant’s arguments ask the Office to not consider the actual statute and base our decision solely on statements from court/board cases that do not directly decide what an adequate written description is for a plant variety.
Lastly, 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, 54Fed. Reg. 34,864 (August 22, 1989) at 34,880).
A deposit is necessary but not sufficient to meet the requirements of written description. A plant described only by a deposit cannot be examined; the patent office does not have the facilities to grow up the claimed plant and all tomato plants in the art to compare their phenotypes and do a genetic analysis on the claimed plant and plants with the same phenotype or a phenotype that makes obvious the claimed plant to see if the claimed plant is genetically related to the prior art plant. If a deposit were all that is required to describe a corn plant, then every future tomato breeder would need to obtain seed of each and every patented tomato plant and perform a phenotypic comparison and genetic analysis to determine if there is art on any plant they invent.
Further, as deposits do not need to be maintained into perpetuity, the genetic information provided therein would no longer be available if there is a 5-year gap after the last request, shutting later breeders out of the information therein. Words describing the phenotype and parents of a corn plant do not exclude future inventors from of a description of a prior art corn plant.
Likewise, Applicant providing phenotype and/or parental information as a response to a Request for Information would not be sufficient for examination, as a genetic analysis on the claimed plant and plants with the same phenotype or a phenotype that makes obvious the claimed plant would still be needed. A response to a Request for Information may be filed as a trade secret, and expunged from the application. Phenotype and/or parental information provided only as a trade secret does not inform the public about critical genetic description about the claimed plant.
Information provided in a response to a Request for Information is not part of the specification.
Phenotypic and parental (genetic) information as part of the specification and a deposit are all necessary parts of the description of a plant line.
Applicant urges that the subject application demonstrates that plants comprising the QTL on chromosome 11 possess tolerance to ToBRFV but not to Stemphylium (Remarks, page 18, paragraph 2).
This argument is unpersuasive, because tolerance to ToBRFV but not to Stemphylium is a trait insufficient to differentiate a variety by itself. Applicant has not provided the breeding history of the variety, which is necessary to conduct an examination and to aid in resolution of questions of infringement.
Conclusion
No claims are allowed.
Claims 1, 8-11, 13-17, 19-20, 27 & 31 may be free of prior art, but additional information is required.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Victoria L DeLeo whose telephone number is (703)756-5998. The examiner can normally be reached M-F 8:00am-12pm EST.
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/VICTORIA L DELEO/Examiner, Art Unit 1662
/Anne Kubelik/Primary Examiner, Art Unit 1663
Request for Information under 37 CFR § 1.105
Applicant and the assignee of this application are required under 37 CFR § 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application.
This request is being made for the following reasons:
Applicant is claiming a Solanum lycopersicum plant, plant part, or seed comprising a QTL of variety LVSTBRFVRES2 NCIMB accession number 43591, but the instant specification is silent about what starting materials and methods were used to produce Solanum lycopersicum variety LVSTBRFVRES2 NCIMB accession number 43591. The requested information is required to make a meaningful and complete search of the prior art.
In response to this requirement, if known, please provide answers to each of the following interrogatories eliciting factual information:
(i) Please supply all of the public or commercial designations/denominations used for the parents of LVSTBRFVRES2 NCIMB accession number 43591. Also provide:
a) Information pertaining to the public availability of the parents of LVSTBRFVRES2 NCIMB accession number 43591.
b) Application or serial numbers of any patent applications or patents in which the parents or siblings of the instant plant are claimed.
c) The breeding methodology and history regarding the development of LVSTBRFVRES2 NCIMB accession number 43591, such as whether single seed descent, bulk method, backcross method, or some other method was used.
d) The filial generation in which the instant plant was chosen.
e) If either of the parents of LVSTBRFVRES2 NCIMB accession number 43591 were obtained from an outside source, please detail that source.
ii) If either of the parents of LVSTBRFVRES2 NCIMB accession number 43591 is not publicly available or has no publication, patent application, or patent in which it is claimed, provide the following:
a) All of the public or commercial designations/denominations used for the parental lines used in making the parents of LVSTBRFVRES2 NCIMB accession number 43591.
b) Information pertaining to the public availability of the parental lines in making the parents of LVSTBRFVRES2 NCIMB accession number 43591.
c) The breeding methodology and history regarding the development of the parents of LVSTBRFVRES2 NCIMB accession number 43591, such as whether single seed descent, bulk method, backcross method, or some other method was used.
d) The filial generation in which the parents of LVSTBRFVRES2 NCIMB accession number 43591 were chosen.
e) For any parent of the parents of LVSTBRFVRES2 NCIMB accession number 43591 that was obtained from an outside source, please detail that source.
f) Application or serial numbers of any patent applications or patents in which the parents or sibs of the parents of LVSTBRFVRES2 NCIMB accession number 43591 are claimed.
If Applicant views any or all of the above requested information as a Trade Secret, then Applicant should follow the guidance of MPEP § 724.02 when submitting the requested information. If any part of the response is marked DO NOT SCAN or TRADE SECRET, Applicant is reminded that a cover letter, not so marked, is to be included.
In responding to those requirements that require copies of documents, where the document is a bound text or a single article over 50 pages, the requirement may be met by providing copies of those pages that provide the particular subject matter indicated in the requirement, or where such subject matter is not indicated, the subject matter found in applicant' s disclosure. Please indicate where the relevant information can be found.
The fee and certification requirements of 37 CFR § 1.97 are waived for those documents submitted in reply to this requirement. This waiver extends only to those documents within the scope of this requirement under 37 CFR § 1.105 that are included in the applicant' s first complete communication responding to this requirement. Any supplemental replies subsequent to the first communication responding to this requirement and any information disclosures beyond the scope of this requirement under 37 CFR § 1.105 are subject to the fee and certification requirements of 37 CFR § 1.97 if submitted subsequent to a first Office action on the merits.
The applicant is reminded that the reply to this requirement must be made with candor and good faith under 37 CFR § 1.56. Where the applicant does not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item.
This requirement is subject to the provisions of 37 CFR §§ 1.134, 1.135 and 1.136 and has a shortened statutory period of 2 months. EXTENSIONS OF THIS TIME PERIOD MAY BE GRANTED UNDER 37 CFR 1.136(a).
This requirement is an attachment of the enclosed Office action. A complete reply to the enclosed Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the enclosed Office action.
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