DETAILED ACTION
Claims 1-8 and 10-11 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The objection to claims 1, 3-8 and 10 because of informalities is withdrawn in light of Applicant’s amendment to the claims.
The terminal disclaimer filed on 4 June 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent Nos. 11,039,588 and 12,016,282 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The rejection of claims 1-4 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the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 1-11 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,039,588 is withdrawn in light of Applicant’s filing a terminal disclaimer.
The rejection of claims 1-11 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,016,282 is withdrawn in light of Applicant’s filing a terminal disclaimer.
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 5-8 and 10-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 5 February 2026, as applied to claims 1-11. Applicant’s arguments filed 4 June 2026 have been fully considered but they are not persuasive.
Claim 5 is drawn to a method of selecting a Cucurbita plant with a TolCNDV tolerance or resistance QTL by assaying for the markers, and claim 8 is drawn to a method of selecting a a Cucurbita plant with a TolCNDV tolerance or resistance QTL by PCR and sequencing.
The markers are naturally present in at some C. moschata plants (example 4).
Detecting or identifying such plants with the markers is merely detecting or identifying a natural phenomenon.
Claim 5 recites the additional element that determining the presence of the markers is selecting plants. Thus, selecting is merely detecting a natural phenomenon.
Dependent claims 6 and 10 recite the additional element of the plant species or genus. However, C. moschata plants are among those recited. Thus, these claims are not directed to significantly more than processes of nature.
Dependent claims 7 and 11 recite the additional element of that the markers were introgressed into the plant from a C. moschata plant. However, C. moschata plants when crossing with one another, introgress genes to each other. Thus, these claims are not directed to significantly more than processes of nature.
Response to Arguments
Applicant urges that claims 5-11 [sic] are directed to methods using molecular genetic techniques that require specific techniques and physical laboratory steps that distinguishes these claims from diagnostic claims that merely observe a natural relationship and support agricultural innovation (response pg 8).
This is not found persuasive. Mayo (Mayo Collaborative Svcs. v. Prometheus Labs., 566 U.S. 66, 132 S. Ct. 1289, 1297 (2012)) indicated that methods of identifying a law of nature are ineligible. In Mayo the “additional steps [of administering and determining] are not themselves natural laws but neither are they sufficient to transform the nature of the claim.”.
Applicant urges that the inclusion of a selection action distinguishes these claims from diagnostic claims that merely observe a natural relationship (response pg 8).
This is not found persuasive because the claims recite that the process of detection is the same as selection.
Applicant urges that the physical transformations, technical steps and human-engineered processes are more than a process of nature (response pg 8).
This is not found persuasive because the recited physical transformations, technical steps and human-engineered processes merely identify a natural relationship. The method by which that relationship is identified does not make the method eligible.
Contrast instant claims 5-8 and 10-11 with instant claims 1-4. Claims 1-4 recite a process that is applied to plants in which the markers were detected that is not done with plants in which the markers were not detected and that does not occur in nature, thereby integrating the judicial exception into a practical application.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5, 7-9 and 11 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 that 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 pre-AIA 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 set forth in the Office action mailed 5 February 2026, as applied to claims 1, 3-5, 7-9 and 11. Applicant’s arguments filed 4 June 2026 have been fully considered but they are not persuasive.
Claims 1, 5, 7, 8 and 11 require a Cucurbita plant with a TolCNDV tolerance or resistance QTL associated with markers SEQ ID NO:8, SEQ ID NO:9 and/or SEQ ID NO:10.
The specification describes no plants other than C. pepo, C. moschata, C. pepo X C. moschata, or C. moschata X C. pepo plants with the QTL. The specification describes no Cucurbita plants of other species with the QTL.
Thus, the specification does not describe species over the full scope of the claims. One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species.
Because Cucurbita plants or plants of other genera with the QTL over the full scope of the claims, the methods of detecting the QTLs are likewise not described, and the specification fails to provide an adequate written description of the claimed invention.
Claim 3 requires that the C. pepo plant be a derivative of variety TLG. This is interpreted as being a progeny of any generation.
The specification does not describe any derivatives or progeny of TLG. The specification does not describe the structural features that distinguish derivatives of variety TLG from other C. pepo plants.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the compositions used in the claimed methods, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Arguments
Applicant urges that the claims are drawn to methods of selection and thus do not require that every plant of the genus Cucurbita have the disclosed markers; the common attribute or feature then, are the disclosed the marker sequences (response pg 9).
This is not found persuasive. The rejection does not require that every plant of the genus Cucurbita have the disclosed markers. However, because the last step of the method is selecting a plant with the marker (claim 1) or detecting or determining the presence of the marker in DNA from a plant (claims 5 and 8, respectively), the last steps of these methods require that starting material include plants with the marker. The specification describes no plants other than C. pepo, C. moschata, C. pepo X C. moschata, or C. moschata X C. pepo plants with the markers. The specification describes no Cucurbita plants of other species with the markers. Thus, the full scope of the starting material of the claimed methods is not described.
Applicant urges that the specification clearly describes multiple ways in which to detect the markers and such methods are well known in the art (response pg 9).
This is not found persuasive. The rejection is not that the method steps are not described. The rejection is that the full scope of the starting material of the claimed methods is not described.
Claims 1 and 3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims require seed of C. pepo variety TLG.
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 TLG at the NCIMB, but 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 was 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 was not made and accepted under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Claims 2 and 4 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
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.
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.
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.
/Anne Kubelik/Primary Examiner, Art Unit 1663
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