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 I, consisting of claims 1-26, in the reply filed on 19 May 2026 is acknowledged. Applicant has elected the species of QTL on chromosome 2 for examination.
Claim Status
Claims 1-2, 4-6 & 9-26 are under examination on the merits.
Claims 3, 7-8, and 27-30 are withdrawn as non-elected subject matter.
Priority
Claims 1-2, 4-6 & 9-26 receive the U.S. effective filing date 11 Mar 2022.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [p.10, ¶23]. 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 ‘TAQMAN’, which is a trade name or a mark used in commerce, has been noted in this application [p.5, ¶1]. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-6 & 9-26 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.
Claims 1-2, 4-6 & 9-26 are drawn to cultivated tomato plants carrying recombinant chromosomal segments that confer resistance to TSWV donated by the wild S. pimpinellifollium ‘SPRJ2018’. Claims 1 & 17, from which all others depend, recite a ‘chromosomal segment on chromosome 2’ (i.e. a QTL) and a ‘chromosomal segment on chromosome 5’ (i.e. a QTL).
All claims require the causative gene(s) or allele(s) present on such chromosomal segments that confer disease resistance. However, as currently written these are genus claims because they recite large segments of chromosomes that reasonably include many genes, and potentially more than a single gene influencing disease susceptibility. Genus claims require a sample of representative species or definition of the structure/function claimed.
Applicant does not confirm/recite the causative gene within the chromosomal segment(s) being referred to or recite specific haplotype marker profile (i.e. linkage block structure) of the chromosomal segment(s). Applicant does not recite an individual marker and/or causative SNP that would indicate the specific structure or nucleotide polymorphism(s) contributing disease resistance. Furthermore, a review of prior art does not provide description of the causative gene(s) or provide description of the required structures contributed by such chromosome segments in S. pimpinellifolium.
Because of this the independent claims, reciting only undefined chromosomal segments, are indefinite as to the scope of genes or structures encompassed. As such, claims 1 & 17 are rejected, as are all dependent claims 2, 4-6, 9-16 & 18-26.
Claims 1 & 17 recite the limitation of a plant which is resistant to ‘resistance breaking isolates’ of TSWV. Claim language does not limit the TSWV strains to any particular isolate of TSWV.
Referring to the specification, Applicant indicates certain embodiments of ‘resistance breaking isolates’ are those which are Sw-5b breaking TSWV isolates [p.4, ¶8]. They describe the role of the Sw-5b resistance locus [p.7, ¶16] and refer to these using the term “Sw-5b-breaking TSWV isolates” [p.7, ¶17, line 2]. Applicant indicates ‘resistance breaking isolate’ refers to newly occurring strains of TSWV that can overcome resistance conferred by known TSWV alleles, such as Sw-5b.
While it appears Applicant’s invention is directed to testing against very specific, currently known isolates capable of overcoming Sw-5b, it is notable that language used in claims leaves room for interpretation as to whether the ‘resistance breaking isolates’ being claimed by Applicant are limited to (a) existing, defined strains of TSWV known to overcome Sw-5b resistances, (b) any and all potential forms of TSWV that can overcome Sw-5b resistance including those that may have not been described, or, (c) any and all viral strains broadly capable of overcoming any form of TSWV resistance, of which Sw-5b is merely a single exemplary embodiment of.
Because the scope of these claims varies depending on interpretation of what constitutes the specific viral strain and/or identity of a generic ‘resistance breaking isolate’ vs ‘Sw-5b-breaking TSWV isolates’, it is unclear where the metes and bounds of such a claim are, and how one would avoid infringement. As such, claims 1 & 17 and their dependent claims 2, 4-6 & 9-16 & 18-26 are rejected as indefinite.
Claim 6 incorporates an external reference. The claim recites a genomic position in the reference genome ‘public tomato genome sequence SL5.0’.
Claims are to be as complete as possible without incorporating essential details by reference. The position or range encompassing the claimed allele is essential material because one would need to know the specific position(s) indicated to understand the limitations of the claims.
Because the identity of the claimed chromosomal segments relies on positional information which is described only in an updatable, external reference (i.e. an external genome sequence) and which is not described in the patent literature, this is an improper incorporation by reference.
Because the scope of the claims varies depending on the status of an updatable, external reference, claim 6 is rejected.
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 1-2, 4-6 & 9-26 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 claims contain 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 all require seed of the donor line S. pimpinellifolium ‘SPRJ2018’.
Since the S. pimpinellifolium plant and/or seed claimed is essential to the 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.
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. In reviewing deposit information provided [p.29, ¶103], Applicant has stated only that material will be available to ‘persons entitled thereto’ upon request.
It is unclear if Applicant considers the general public as onesuch ‘entitled thereto’ critical germplasm. It is unclear if Applicant intends to place obligations or restrictions on those accessing the raw materials of their invention from the depository, or if Applicant is suggesting they reserve the ability to deny the public access to such germplasm (i.e. those Applicant subjectively determines to not be ‘entitled to’ seed).
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.
Claims 1-2, 4-6 & 9-26 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 1 & 17 require the causative gene(s) or allele(s) present on such chromosomal segments that confer disease resistance. This requires that Applicant is in possession of a defined genetic determinate that confers TSWV resistance. As written, claims to broad ‘chromosomal segments’ require description supporting Applicant is in possession of such a broad genus of genetic determinates.
However, upon review of the written description, Applicant does not confirm/recite the causative gene within the chromosomal segment(s). Applicant does not recite an individual marker and/or causative SNP that would indicate the specific structure or nucleotide polymorphism(s) drawn to, which confer disease resistance. Furthermore, a review of prior art does not provide description of the causative gene(s) or provide description of the required structures contributed by such chromosome segments in S. pimpinellifolium.
This does not reasonably convey to one skilled in the relevant art that the inventor or a joint inventor had possession of the claimed invention, it being a broad genus (i.e. chromosomal segment) conferring TSWV resistance. Because of this, claims 1 & 17 and their dependent claims 2, 4-6 & 9-16 & 18-26 are rejected.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, 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 an improved tomato cultivar that requires disease resistance QTL/alleles introgressed from the S. pimpinellifolium line ‘SPRJ2018’. 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 is the source of the ‘SPRJ2018’ donor? Please supply all of the designations/denominations used for this germplasm or breeding line or the donor to the SPRJ2018 line. Applicant should provide the original public line, if available, that was used to make SPRJ2018 and has the claimed TSWV resistance trait.
(ii) At or before the time of filing of the instant application or any provisional application to which benefit is claimed, had said ‘SPRJ2018’ S. pimpinellifolium line been disclosed or made publicly available? If so, under what designation/denomination and under what conditions were said strain disclosed or made publicly available and from when to when?
(iii) The specification recites specific QTL or haplotypes contributed by ‘SPRJ2018’. Do all S. pimpinellifolium inherently contain the claimed resistance QTL? Are the traits of interest (i.e. TSWV resistance) inherent to the original source material, or was it adapted in any way?
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 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
Prosecution Insights