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/Restrictions
Applicant's election with traverse of Group 1, encompassing Claims 17, 18 (now cancelled), 21, 22, 25, and 29 in the reply filed on 04/27/2026 is acknowledged. Examiner has elected to rejoin Claims 19 and 26-28 with the claims encompassed by Group I and acknowledges Applicant’s election of SEQ ID NO: 13, with traverse.
The traversal to both the restriction requirement and election of species is made by Applicant on several grounds. In particular, Applicant argues that the elected group now includes Claims 17, 19, 21-35, and 37 (newly added) on the grounds that Claim 17 now requires the limitation “…wherein the QTL is present on chromosome 6 in the genome of a seed of Capsicum annuum ST17-1157, representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602” (Remarks, pg. 6).
This is not found persuasive because as shown in the claim interpretation of Claim 17 in the 35. U.S.C. §101 rejection and 35 U.S.C. §102(a)(1) rejection below, the newly added claim limitation does not add patentable weight to Claim 17, nor does the limitation render Claim 17 free of the prior art. The QTL found in seeds of ST17-1157, deposited at NCIMB under accession number NCIMB 43602 are not necessarily unique to the recited genetic background, but instead could be present in plants of other genetic backgrounds. Thus, requiring the QTL be present in ST17-1157, deposited at NCIMB under accession number NCIMB 43602, does not itself constitute a special technical feature, as the instantly claimed Capsicum plant is not required to be derived from the recited seed deposit. A such, the new limitation does not provide a special technical feature that defines a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
Applicant also argues that claims 30-32 relate to a method for producing a plant of elected Group I and claims 33-35 relate to a method for detecting and/or selecting a plane of elected Group I for the purpose of detection of powdery mildew resistance. Thus, at least claims 30-35 have unity of invention with elected Group I because the claims together are directed to "(3) [a] product, a process specially adapted for the manufacture of the said product, and a use of the said product" as provided in 37 CFR 1.475(b) (Remarks, pg. 6).
This is not found persuasive as the lack of unity finding was made using the a posteriori analysis. Claims 30-35 lack a shared technical feature in common with the claims of Group I (encompassing Claims 17, 21, 22, 25, and 29), over the teachings of the prior art found in Just et al. (WO 2020/214451). Examiner made a prima facie case that lack of unity is not present, as the common technical feature does not make a contribution over the prior art, and the Applicant has not rebutted whether the invention represents a new contribution over the common technical feature.
Applicant also argues that the Patent Office alleges a posteriori lack of unity of invention on the basis of the teachings of Just et al. (WO 2020/214451). However, Applicant submits that this finding of lack of unity of invention is premature in the present application as a full search of the prior art has yet to have been conducted (Remarks, pg. 7).
This is not found persuasive. A finding of lack of unity is never made final and is re-evaluated every step of prosecution. At the point the base claim is free of the prior art, unity of invention will be established for every claim that requires the special technical feature. Even after a complete search of the art during the synthesis of this Office Action, the base claim is still not free of the prior art (See 35 U.S.C. §102(a)(1) and 35 U.S.C. §103 rejections below), and as such, lack of unity is not present, as the common technical feature does not make a contribution over the prior art
Applicant's provisional election with traverse of allele combination A, and C. annuum in the reply filed on 04/27/2026 is acknowledged. However, as there was no election of species associated with provisionally elected Group I, and because Claim 19 has been rejoined with Group I, this provisional election is premature and therefore moot.
The requirement is still deemed proper and is therefore made FINAL.
Additionally, newly submitted Claim 37 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 37 is drawn to the plant according to Claim 17, wherein the presence of the QTL comprises the presence of one or more of one or more of allele A of PE-0006634 (SEQ ID NO: 57), allele A of PE 0006718 (SEQ ID NO: 58), allele G of PE-0012892 (SEQ ID NO: 59), allele A of PE-0004191 (SEQ ID NO: 60), allele A of PE-0005575 (SEQ ID NO: 61), allele A of PE-0006320 (SEQ ID NO: 62), allele T of PE 0016499 (SEQ ID NO: 63), allele A of PE-0013625 (SEQ ID NO: 64) and/or allele A of PE-0022671 (SEQ ID NO: 65), which would have been subject to a species election, like the sequences recited in Claim 19, set forth in the Office Action dated 02/25/2026 as groups of inventions which are not so linked as to form a single inventive concept under PCT Rule 13.1, with the species of allele sequences recited in Group II for lacking the same or a corresponding special technical feature as to form a single inventive concept. Because a provisional election of species has been made for Claim 19, the individual alleles recited in Claim 37 will be interpreted as being non-elected inventions in light of the election of SEQ ID NO: 13 in Applicants Remarks dated 04/27/2026, thus Claim 37 is withdrawn from consideration at this time for being directed to a non-elected invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claim 37 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Priority
Acknowledgment is made of applicant' s claim for foreign priority under 35 U.S.C. 119 (a)-(d). As such, the effective filing date of Claims 17, 19, 21-35 and 37 is August 6th, 2021.
Status of the Claims
Amendments dated 04/27/2026 have been entered.
Claims 1-16, 18, 20, and 36 are cancelled by Applicant.
Claim 37 is newly added.
Claims 17, 19, 21-35 and 37 are pending.
Claims 23-24, 30-35, and 37 are withdrawn from consideration as being directed to a non-elected invention.
Claims 17, 19, 21-22, and 25-29 are examined herein.
Information Disclosure Statement
The Information Disclosure Statement filed on 02/02/2024 is in compliance with the provisions
of 37 CFR 1.97 and has been considered in full. A signed copy of the list of references cited from the IDS
is included with this Office Action.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."”
In the current case, the view number for Figures 1-5 are preceded by the word “Figure” instead
of the abbreviation “FIG.”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office
action to avoid abandonment of the application. Any amended replacement drawing sheet should
include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is
being amended. The figure or figure number of an amended drawing should not be labeled as
“amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the
replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate
changes made to the brief description of the several views of the drawings for consistency. Additional
replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing
sheet submitted after the filing date of an application must be labeled in the top margin as either
“Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by
the examiner, the applicant will be notified and informed of any required corrective action in the next
Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pgs. 8 and 12. 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 use of the term KASPar™ on pg. 30, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claims 17 and 26-28 are objected to because of the following informalities:
Claim 17 should be amended to recite “A Capsicum plant, or plant cell or plant part thereof, resistant to powdery mildew caused by the fungal pathogen Leveillula taurica,
Claim 26 should be amended to recite “The plant according to claim 17, wherein the plant Capsicum…”
Claim 27 should be amended to recite “The plants according to claim 26, wherein the plant Capsicum…”
Claim 28 should be amended to recite “The plant according to claim 17, wherein the plant
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 17, 19, 21-22, and 25-29 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. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend.
Claim 17 recites, in part, “A Capsicum plant resistant to powdery mildew caused by the fungal pathogen Leveillula taurica….wherein the plant comprises introgressed in its genome a quantitative trait locus (QTL) conferring resistance to powdery mildew” which renders the claim indefinite. It is unclear to one of ordinary skill in the art if the claim should be interpreted to mean that the introgressed QTL confers resistance to all pathogens that cause the disease sign of powdery mildew or if the recitation reciting “A Capsicum plant resistant to powdery mildew caused by the fungal pathogen Leveillula taurica” is meant to limit the QTL to only providing resistance to the fungal pathogen Leveillula taurica. As such, one of ordinary skill in the art is not reasonably apprised of the metes and bounds of the claimed invention. For purposes of examination, Claim 17 will be broadly interpreted to mean that the introgressed QTL confers resistance to all pathogens that produce a powdery mildew sign of disease on infected plants. This determination does not relieve Applicant from their duty to amend the claims in any further correspondence.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 17 recites the broad recitation “marker PE-0014628”, and the claim also recites “SEQ ID NO: 1" in parenthesis which is the narrower statement of the range/limitation. Claim 17 also recites the broad recitation “marker PE-0021476 ”, and the claim also recites “SEQ ID NO: 2" in parenthesis which is the narrower statement of the range/limitation. It is unclear if the information within the parentheses is intended to further modify the limitation of the markers or if the information within the parentheses is inherent to the claimed markers. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 19 recites the broad recitation "allele T of PE-0056544" (elected species), and the claim also recites "SEQ ID NO: 13" in parentheses which is the narrower statement of the range/limitation. In regard to the elected species and all other alleles recited in Claim 19, it is unclear if the information within the parentheses is intended to further modify the limitation of the markers or if the information within the parentheses is inherent to the claimed markers. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections – 35 USC § 112
Deposit of Biological Material
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.
Claim 25 is 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 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.
Claim 25 requires seeds of Capsicum annuum ST17-1157, representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602.
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 has deposited seeds for Capsicum annuum ST17-1157 at the National Collections of Industrial, Food and Marine Bacteria (NCIMB) under accession number NCIMB 43602 on 04/22/2020 (Specification, pg. 39, lines 10-18), but there is no indication that the seeds have been accepted. Further, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made and accepted under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
If the deposit has not been 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.
Claim Rejections – 35 USC § 112
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 17, 19, 21-22, and 25-29 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.
Claims 17, 19, 21-22, and 25-29 are broadly directed to a Capsicum plant resistant to powdery mildew caused by the fungal pathogen Leveillula taurica, or a cell or plant part thereof, wherein the plant comprises, introgressed in its genome, a quantitative trait locus (QTL) conferring resistance to powdery mildew, wherein the QTL is located on chromosome 6 within the genomic interval delimited by the marker PE-0014628 (SEQ ID NO: 1) and the marker PE-0021476 (SEQ ID NO: 37), wherein the QTL is present on chromosome 6 in the genome of a seed of Capsicum annuum ST17-1157, representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602, as well as a Capsicum seed which can be grown into the plant described above.
In Claims 17, 19, 21-22, and 25-29, the introgressed resistance QTL is broadly claimed as encompassing resistance to any pathogen that produces a powdery mildew sign of disease on infected plants (See Claim Interpretation in 35 U.S.C. §112(b) rejection above).
Powdery mildew is the name given to diseases resulting from infection by fungi that produce a white to gray, powdery growth on the surfaces of leaves and sometimes other plant parts. Powdery mildew is the general name of the fungal group belonging to the order Erysiphales of the phylum Ascomycota. Powdery mildews consist of approximately 900 fungal species among 18 genera that can infect 10,000 different species of angiosperms containing many economically important, cultivated species such as cereals, vegetables, fruit trees, and other flowering plants [See Takamatsu (2018); Introduction]. The state of the art, regarding which fungal pathogens produce a powdery mildew disease sign in plants from the genus Capsicum teaches that the primary fungal pathogen that produces a powdery mildew sign on pepper plants is Leveillula taurica [See Seminis (2017), pg. 1].
In the instant specification, Applicant describes identification of resistance sources to natural infections of Leveillula taurica (pg. 39, Example 1), as well as disease assays and exposure of Capsicum plants to the fungal pathogen Leveillula taurica (pg. 40, Example 2; pg. 43, Example 4; pg. 57, Example 10).
Applicant does not describe whether the claimed QTL provides resistance to all known pathogens that produce a powdery mildew disease sign in infect plants, particularly plants in the broadly claimed Capsicum genus. Applicant does not describe the use of any other pathogens known in the art to produce the powdery mildew disease sign in disease assays to determine if the claimed QTL provides resistance in the broadly claimed Capsicum genus of plants.
Based on the teachings of the instant specification and the prior art, Applicant does not describe a sufficient number of Capsicum plants comprising the claimed QTL with resistance to all known pathogens that produce the powdery mildew disease sign, and the described Capsicum plants with resistance to Leveillula taurica derived from a specific QTL on chromosome 6 are not sufficient to be representative across the broad genus of Capsicum plants with resistance to any pathogen that produces the powdery mildew disease sign known in the art.
One of ordinary skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the broadly claimed genus, in view of the disclosed species. Therefore, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
In Claims 17, 19, 21-22, and 26-29, the broad genus of Capsicum plants, and seeds to be grown into said plants, can be derived from any Capsicum germplasm, any Capsicum annuum, Capsicum baccatum, Capsicum frutescens, Capsicum chinense, Capsicum pubescens or Capsicum chacoense germplasm, or any bell pepper germplasm. Although the claims recite “wherein the QTL is present on chromosome 6 in the genome of a seed of Capsicum annuum ST17-1157, representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602”, this recitation does not actually require that the Capsicum plant recited in Claim 17 is derived from Capsicum annuum ST17-1157, merely that the QTL located on chromosome 6 within the genomic interval delimited by the marker PE-0014628 and the marker PE-0021476 can also be found in Capsicum annuum ST17-1157 plants, without requiring that ST17-1157 plants be the source of the QTL and associated resistance.
In the instant specification, Applicant describes that one Capsicum annuum line, LT17, appeared to be symptomless to Leveillula taurica infection in a greenhouse disease assay for identifying resistant and susceptible Capsicum annuum lines (pg. 39, Example 1). Applicant describes an evaluation of the resistance level of Capsicum annuum line LT17, determining that this single line had a high level of resistance to Leveillula taurica infection, wherein the resistance was not associated with a previously identified QTL on linkage group LG1/8 (pgs. 39-43, Tables 5-6). Applicant describes crossing the susceptible Capsicum annuum line Maor with the resistant Capsicum annuum LT17 line, to produce an F2 population used to generate a linkage map and detect QTLs involved in the Leveillula taurica resistance (pg. 43-44, Example 4). Applicant describes using the previously mentioned F2 population to identify one major QTL on linkage group 6 with the favorable allele originated from the LT17 source of resistance (pg. 45, Figure 3). Applicant describes that the newly identified QTL on linkage group 6— only found in plants or progeny plants with LT17 as a parental variety— seems to provide resistance to Leveillula taurica, even in the absence of two known major QTLs for resistance to Leveillula taurica on linkage group 1/8 and linkage group 4 (pg. 45; Table 7). Applicant describes F2 plants of the cross (Maor x L T17) that were selected and selfed to produce F2:3 families, wherein a total of 25 F2 plants were selected, 12 being homozygous for favorable allele (i.e., resistance allele) inherited from LT17 and 13 being homozygous for unfavorable allele inherited from Maor at the region of the QTL located on chromosome 6, using SNP markers PE-0014628, PE-0056542, and PE-0021476 to identify the molecular profile at the chr6 QTL position (pg. 45-46, Example 6, Table 8). Applicant describes a disease assay using the 25 F2:3 families wherein the plants were inoculated with 2 Leveillula taurica strains, wherein the results of this assay provide evidence that plant being homozygous for favorable allele (i.e., resistance allele) inherited from LT17 had greater disease resistance to Leveillula taurica when compared to plants not homozygously comprising the inherited allele from LT17 (pg. 47, Example 6, Figure 4).
Applicant does not describe any Capsicum plant from any diverse germplasm in the art, any bell pepper from any germplasm known in the art, or any Capsicum annuum, Capsicum baccatum, Capsicum frutescens, Capsicum chinense, Capsicum pubescens or Capsicum chacoense germplasm known in the art comprising the QTL on chromosome 6 which confers resistance to Leveillula taurica, much less all known pathogens that produce the powdery mildew disease sign and comprising the claimed allele T of PE-0056544, other than lines derived from the Capsicum annuum plant designated as LT17.
It is known in the art that “there is no guarantee that DNA markers identified in one population will be useful in different populations, especially when the populations originate from distantly related germplasm.” [Collard et al. (2005), pg. 186] For this reason, unless the broad genus of claimed Capsicum plants are derived from LT17 (as closely related progeny plants) or are LT17 plants, Applicant does not provide any evidence that the claimed markers (allele T of PE-0056544) would be associated with the required QTL in the majority of Leveillula taurica resistant Capsicum plants, much less powdery mildew resistant Capsicum plants. The instant applicant does not describe a sufficient number of Capsicum plants, bell pepper plants, Capsicum annuum, Capsicum baccatum, Capsicum frutescens, Capsicum chinense, Capsicum pubescens or Capsicum chacoense plants derived from a wide range of parental genotypes which comprise the required powdery mildew resistance, the recited QTL , and the recited markers (allele T of PE-0056544). The application only describes LT17 and closely related progeny plants of LT17 comprising the required powdery mildew resistance, the recited QTL, and the recited markers (allele T of PE-0056544). For this reason, the described Capsicum annuum plant LT17, and closely related progeny thereof, are not sufficient to be representative across the broad genus that is encompassed by the instant claims.
Scope of Enablement
Claims 17, 19, 21-22, 26-28, and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for Capsicum plants that are direct progeny of LT17 or closely related progeny of LT17, including Capsicum annuum ST17-1157 representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602, does not reasonably provide enablement for Capsicum plants which are not progeny of LT17, or are not closely related progeny of LT17. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Claims 17, 19, 21-22, and 26-29 are broadly directed to a Capsicum plant resistant to powdery mildew caused by the fungal pathogen Leveillula taurica, or a cell or plant part thereof, wherein the plant comprises, introgressed in its genome, a quantitative trait locus (QTL) conferring resistance to powdery mildew, wherein the QTL is located on chromosome 6 within the genomic interval delimited by the marker PE-0014628 (SEQ ID NO: 1) and the marker PE-0021476 (SEQ ID NO: 37), wherein the QTL is present on chromosome 6 in the genome of a seed of Capsicum annuum ST17-1157, representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602, as well as a Capsicum seed which can be grown into the plant described above.
In Claims 17, 19, 21-22, and 26-29, the broad genus of Capsicum plants, and seeds to be grown into said plants, can be derived from any Capsicum germplasm, any bell pepper germplasm, or any Capsicum annuum, Capsicum baccatum, Capsicum frutescens, Capsicum chinense, Capsicum pubescens or Capsicum chacoense germplasm. Although the claims recite “wherein the QTL is present on chromosome 6 in the genome of a seed of Capsicum annuum ST17-1157, representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602”, this recitation does not actually require that the Capsicum plant recited in Claim 17 is derived from Capsicum annuum ST17-1157, merely that the QTL located on chromosome 6 within the genomic interval delimited by the marker PE-0014628 and the marker PE-0021476 can also be found in Capsicum annuum ST17-1157 plants, without requiring that ST17-1157 plants be the source of the QTL and associated resistance.
In the instant specification, Applicant teaches that one Capsicum annuum line, LT17, appeared to be symptomless to Leveillula taurica infection in a greenhouse disease assay for identifying resistant and susceptible Capsicum annuum lines (pg. 39, Example 1). Applicant teaches an evaluation of the resistance level of Capsicum annuum line LT17, determining that this single line had a high level of resistance to Leveillula taurica infection, wherein the resistance was not associated with a previously identified QTL on linkage group LG1/8 (pgs. 39-43, Tables 5-6). Applicant teaches crossing the susceptible Capsicum annuum line Maor with the resistant Capsicum annuum LT17 line, to produce an F2 population used to generate a linkage map and detect QTLs involved in the Leveillula taurica resistance (pg. 43-44, Example 4). Applicant teaches using the previously mentioned F2 population to identify one major QTL on linkage group 6 with the favorable allele originated from the LT17 source of resistance (pg. 45, Figure 3). Applicant teaches that the newly identified QTL on linkage group 6— only found in plants or progeny plants with LT17 as a parental variety— seems to provide resistance to Leveillula taurica, even in the absence of two known major QTLs for resistance to Leveillula taurica on linkage group 1/8 and linkage group 4 (pg. 45; Table 7). Applicant teaches F2 plants of the cross (Maor x L T17) that were selected and selfed to produce F2:3 families, wherein a total of 25 F2 plants were selected, 12 being homozygous for favorable allele (i.e., resistance allele) inherited from LT17 and 13 being homozygous for unfavorable allele inherited from Maor at the region of the QTL located on chromosome 6, using SNP markers PE-0014628, PE-0056542, and PE-0021476 to identify the molecular profile at the chr6 QTL position (pg. 45-46, Example 6, Table 8). Applicant teaches a disease assay using the 25 F2:3 families wherein the plants were inoculated with 2 Leveillula taurica strains, wherein the results of this assay provide evidence that plant being homozygous for favorable allele (i.e., resistance allele) inherited from LT17 had greater disease resistance to Leveillula taurica when compared to plants not homozygously comprising the inherited allele from LT17 (pg. 47, Example 6, Figure 4).
Applicant does not teach any Capsicum plant from any diverse germplasm in the art, any bell pepper plants from any diverse germplasm known in the art, or any Capsicum annuum, Capsicum baccatum, Capsicum frutescens, Capsicum chinense, Capsicum pubescens or Capsicum chacoense plants from any diverse germplasm in the art comprising the QTL on chromosome 6 which confers resistance to Leveillula taurica, much less all known pathogens that produce the powdery mildew disease sign and comprising the claimed allele T of PE-0056544, other than lines derived from the Capsicum annuum plant designated as LT17.
It is known in the art that “there is no guarantee that DNA markers identified in one population will be useful in different populations, especially when the populations originate from distantly related germplasm.” [Collard et al. (2005), pg. 186] For this reason, unless the broad genus of claimed Capsicum plants are derived from LT17 (as closely related progeny plants) or are LT17 plants, Applicant does not provide any evidence that the claimed markers (allele T of PE-0056544) would be associated with the required QTL in the majority of Leveillula taurica resistant Capsicum plants, much less powdery mildew resistant Capsicum plants.
Given the unpredictability of any given markers being linked to any given QTL in diverse germplasm, and given the limited number of working examples, it would require undue experimentation for one of ordinary skill in the art to screen powdery mildew resident Capsicum plants, bell pepper plants, and Capsicum annuum, Capsicum baccatum, Capsicum frutescens, Capsicum chinense, Capsicum pubescens or Capsicum chacoense plants for the presence or absence of the claimed QTL on chromosome 6 and the presence or absence of allele T of PE-0056544 to determine which powdery mildew resistant Capsicum plants do, in fact, comprise the QTL on chromosome 6 and last least one of the SNP markers, specifically allele T of PE-0056544.
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 17, 19, 21-22, and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (e.g., compositions of matter) (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1).
Claims 17 and 29 are drawn to a Capsicum plant resistant to powdery mildew caused by the fungal pathogen Leveillula taurica, or a cell or plant part thereof, wherein the plant comprises, introgressed in its genome, a quantitative trait locus (QTL) conferring resistance to powdery mildew, wherein the QTL is located on chromosome 6 within the genomic interval delimited by the marker PE-0014628 (SEQ ID NO: 1) and the marker PE-0021476 (SEQ ID NO: 37), wherein the QTL is present on chromosome 6 in the genome of a seed of Capsicum annuum ST17-1157, representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602, as well as a Capsicum seed which can be grown into the plant described above.
Although the claims recite “wherein the QTL is present on chromosome 6 in the genome of a seed of Capsicum annuum ST17-1157, representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602”, this recitation does not actually require that the Capsicum plant recited in Claim 17 or the Capsicum seed grown into the plant of Claim 17 is derived from Capsicum annuum ST17-1157, merely that the recited QTL located on chromosome 6 within the genomic interval delimited by the marker PE-0014628 and the marker PE-0021476 can also be found in Capsicum annuum ST17-1157 plants, without requiring that ST17-1157 plants be the source of the QTL and associated resistance.
The instant claims also recite “wherein the QTL is located on chromosome 6 within the genomic interval delimited by the marker PE-0014628 and the marker PE-0021476”. The instant specification defines the term QTL as “a genomic region that may comprise one or more genes or regulatory sequences” (pg. 6, lines 21-22) meaning that the limitation above is merely providing a genetic location for where the QTL could be in a Capsicum plant, wherein any Capsicum plant would have this locus if it has an intact chromosome 6, even if it’s a null allele.
Based on the claim interpretations above, it appears that Claim 17 is drawn to any Capsicum plant that has any degree of resistance to powdery mildew and it appear that Claim 29 is drawn to a seed that would grow said Capsicum plant. The prior art teaches that there are Capsicum plants that comprise a natural resistance to fungal pathogens that produce a powdery mildew disease sign (See Lefebvre et al. (2003); Introduction). As such, Claims 17 and 29 are drawn to a natural phenomenon. The claim limitations discussed above do not impose a meaningful limitation on the scope of the claims such that all other are not precluded from using the natural phenomenon; therefore, the claimed Capsicum plant, and seed that grows said plant, comprising resistance to fungal pathogens that produce the powdery mildew disease sign and an intact chromosome 6 cannot be distinguished from other Capsicum plants comprising an intact genome that naturally comprise resistance to fungal pathogens that produce the powdery mildew disease sign. As such, in regard to Claim 19, the presence of the claimed markers are considered part of the natural correlation between Capsicum plants with a natural resistance to fungal pathogens that produce a powdery mildew disease sign (the natural phenomenon defined as the judicial exception), as long as the Capsicum plant comprises an intact chromosome 6.
MPEP 2106.04(c) states that if a claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application (Step 2A, Prong One: YES).
The claims do not include additional elements that are sufficient to amount to significantly more
than the judicial exception because the claimed invention is directed to naturally-occurring process(es),
nucleotides, cells, and organisms. The instant Capsicum plant, and seed that grows said plant, with an intact genome and natural resistance to fungal pathogens that produce a powdery mildew disease sign does not require any additional elements that show a practical application or integration of the natural principle. Therefore, Claims 17, 19, 21-22 and 29 are directed to a natural phenomenon with no additional elements to demonstrate that the claims as a whole integrate the exception in the practical application (Step 2A, Prong 2: NO).
A claim that focuses on use of a product of nature must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the product of nature itself. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S.Ct. 1289,101 USPQ2d 1961 (2012), at 1966. To show integration, the additional elements must relate to the product of nature in a significant way to impose a meaningful limit on the claim scope. Claims 17, 19, 21-22, and 29 do not contain additional elements to demonstrate the claims as a whole integrate the exception in the a practical application and the claims simultaneously do not recite significantly more than the exception itself. Even though Claims 21 and 22 provide limitation for the zygosity of the naturally occurring resistance alleles that are considered part of the natural correlation between Capsicum plants and natural resistance to fungal pathogens that produce a powdery mildew disease sign (the natural phenomenon defined as the judicial exception). Encompassed in Claims 21-22 are natural processes of Mendelian genetics, wherein Capsicum plants naturally segregating into populations of plants being heterozygous for a resistance allele or being homozygous for a resistance allele is a well-known natural phenomenon/natural principle, as evidenced by Just et al. (WO 2020/214451 A1; published 10/22/2020; IDS Document; paragraph 0013; Figure 3). Since there is no meaningful limitation in Claims 17 and 29 that transform the exception in a patent-eligible application, such that the claims do not amount to significantly more than the exception itself, Claims 17 and 29 are not patent eligible (Step 2B: NO).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17, 19, 21-22, and 26-29 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Just et al. (WO 2020/214451 A1; published 10/22/2020; IDS Document) .
In regard to Claim 17, although the claim recites “wherein the QTL is present on chromosome 6 in the genome of a seed of Capsicum annuum ST17-1157, representative seeds of which have been deposited at NCIMB under accession number NCIMB 43602”, this recitation does not actually require that the Capsicum plant recited in Claim 17 (or the Capsicum seed grown into the plant of Claim 17) is derived from Capsicum annuum ST17-1157, merely that the recited QTL located on chromosome 6 within the genomic interval delimited by the marker PE-0014628 and the marker PE-0021476 can also be found in Capsicum annuum ST17-1157 plants, without requiring that ST17-1157 plants be the source of the QTL and associated resistance.
Regarding Claims 17 and 19, Just et al. (herein referred to as Just) discloses an agronomically elite Capsicum annuum plant comprising allele conferring resistance to L. taurica on chromosome 6 of said Capsicum annuum plant (pg. 27, Claims 1-3). Although Just discloses markers that are different than the markers claimed in the instant claims, the chromosomal interval of the instantly claimed QTL falls within the chromosomal interval taught and claimed in Just. The interval disclosed by Just is not that large (~6,500 kilobases), and there is nothing known or disclosed to lead one of ordinary skill in the art to believe there is more than one QTL contained within this interval. In general, if there are two separate genes that are close in proximity on the same chromosome such that they are inherited together, these are considered on single locus with two genes rather than being considered separate loci. For this reason, the QTL taught by Just anticipates the claimed QTL.
Regarding Claims 21 and 22, Just discloses in a single embodiment of the invention Capsicum annuum plants that are either homozygous for the resistance allele on chromosome 6 and Capsicum annuum plants that are heterozygous for the resistance allele on chromosome 6, wherein the different zygosities of the resistance alleles have different levels of resistance to L. taurica (paragraph 0013; Figure 3).
Regarding Claims 26-28, Just discloses an agronomically elite Capsicum annuum plant (pg. 27, Claim 1).
Regarding Claim 29, Just discloses a seed that produces the Capsicum annuum plant comprising an allele conferring resistance to L. Taurica on chromosome 6 (pg. 27, Claim 7).
Closest Prior Art
Claim 25 appears to be provisionally free of the prior art. Claim 25 is drawn to a plant that is “progeny of, or is derived from” which renders the claim a product-by-process limitation/claim, wherein so long as the prior art discloses or teaches a Capsicum plant that has the same structure as ST17-1157 (comprising the resistance QTL on chromosome 6), where there is not another claimed process that alters said plant, the prior art plant would be encompassed by the scope of Claim 25. As such, Claim 25 doesn’t require that the plant be a ST17-1157 plant, but rather the plant could be derived from the source material of ST17-1157 (i.e., the LT17 pepper variety). Based on the current record, this statement is provisional because Applicant has not provided any information regarding the source of LT17 (parental genetics), the original source of the resistance allele in LT17 (Is the resistance allele from H3 pepper plants?), or any other names or alternative designations for LT17 known in the art. Without this information, a meaningful comparison of the genetic and phenotypic basis that would structurally distinguish plants derived from LT17 plants from prior art plants cannot be made. Thus, this statement will remain provisional until the necessary information requested under the Request for Information under 37 CFR § 1.105 is received and a complete search of the prior art can be completed.
The closest prior art in regard to Claim 25 can be found in Just et al. (WO 2020/214451 A1; published 10/22/2020; IDS Document) which discloses an agronomically elite Capsicum annuum plant comprising allele conferring resistance to L. taurica on chromosome 6 of said Capsicum annuum plant (pg. 27, Claims 1-3), Just does not teach or provide a rationale for using a Capsicum annuum plant/variety that is derived from LT17 or has the same structural characteristics of LT17 or ST17-1157 in the methods of their invention. In fact, Capsicum plants known as “LT17” do not appear to be known in the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMJAD 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.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
ATTACHMENT TO THE OFFICE ACTION
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 Capsicum annuum plant of ST17-1157, representative seeds of which have been deposited under NCIMB accession number NCIMB 43602, which were the F4 progeny of crossing a Capsicum annuum plant designated as LT17 with a Capsicum annuum plant designated as Maor, from the seed lot denoted as F4 (ST117F04-1157/BLK). However, the instant specification is silent about the source of the Capsicum annuum plant designated as LT17 and the original source of the resistance allele that LT17 carries on chromosome 6. The requested information is required to make a meaningful and complete search of the prior art.
In response to this requirement, please provide answers to each of the following interrogatories eliciting factual information:
(i) What are the parental genetics of the Capsicum annuum plant designated as LT17? Please supply all of the designations/denominations used for the parents of LT17.
(ii) What is the original source of the resistance allele found on chromosome 6 of the Capsicum annuum plant designated as LT17? Does the resistance allele come from a wild-type Capsicum plant? Please supply all of the designations/denominations used for this original source of the resistance allele.
(iii) At or before the time of filing of the instant application or any provisional application to which benefit is claimed, had the Capsicum annuum plant designated as LT17 been disclosed or made publicly available? If so, under what designation/denomination and under what conditions was the Capsicum annuum plant designated as LT17 disclosed or made publicly available and from when to when?
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.
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.
/Amjad Abraham/ SPE, Art Unit 1663
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