DETAILED ACTION
Claims 19-36 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 terminal disclaimers filed on 9 March 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of U.S. Patent Nos. 11,168,336 and 12,018,269 have been reviewed and are accepted. The terminal disclaimers have been recorded.
The objection to claim 27 is withdrawn in light of Applicant’s amendment to the claim.
The rejection of claims 19-36 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 19-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,168,336 is withdrawn in light of Applicant’s filing a terminal disclaimer.
The rejection of claims 19-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,018,269 is withdrawn in light of Applicant’s filing a terminal disclaimer.
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 19-36 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 Solanum lycopersicum plants comprising a gene encoding a TBRFV resistance protein of SEQ ID NO:116, does not reasonably provide enablement for S. lycopersicum plants comprising a gene encoding a protein with 95% identity to SEQ ID NO:116. 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 the invention commensurate in scope with these claims.
Due to Applicant’s amendment of the claims, the rejection is different from the rejection set forth in the Office action mailed 11 December 2025. Applicant’s arguments filed 9 March 2026 have been fully considered but they are not persuasive.
The claims are broadly drawn to Solanum lycopersicum plants, seeds, and plant parts comprising a gene encoding a protein with 95% identity to SEQ ID NO:116. The claims do not specify an activity for the protein, and thus encompass plants, seeds, and plant parts where the protein with 95% identity to SEQ ID NO:116 has no activity at all.
The instant specification, however, only provides guidance for how to use S. lycopersicum plants, seeds, and plant parts comprising a gene encoding a TBRFV resistance protein.
The instant specification fails to provide guidance for how to use S. lycopersicum plants, seeds, and plant parts comprising a protein that is not a TBRFV resistance protein. As such, undue trial and error experimentation would be required to screen through the myriad of Solanum lycopersicum plants, seeds, and plant parts comprising a gene encoding a protein with 95% identity to SEQ ID NO:116 to find a use specific to the protein with 95% identity to SEQ ID NO:116, if a use beyond TBRFV resistance even exists.
However, even though the specification teaches how to use S. lycopersicum plants and plant parts comprising a gene encoding a TBRFV resistance protein with 95% identity to SEQ ID NO:116, it does not teach how to make the full scope of TBRFV resistance proteins with 95% identity to SEQ ID NO:116.
Proteins with at least 95% identity to the 979 amino acid-long SEQ ID NO:116 have up to 48 amino acid substitutions relative to SEQ ID NO:116.
The instant specification fails to provide guidance for how to make TBRFV resistance proteins with up to 48 amino acid substitutions relative to SEQ ID NO:116.
The instant specification fails to provide guidance for which amino acids of SEQ ID NO:116 can be altered and to which other amino acids, and which amino acids must not be changed, to maintain TBRFV resistance activity of the protein. The specification also fails to provide guidance for which amino acids can be deleted and which regions of the protein can tolerate insertions and still produce a functional TBRFV resistance protein.
The specification provides no specific guidance for making amino acid substitutions in SEQ ID NO:116.
Given the insufficient guidance in the specification, one of skill in the art would need to make random amino acid substitutions in SEQ ID NO:116 to obtain the full scope of proteins required by the claims. However, making random amino acid substitutions in proteins is unpredictable.
While proteins are fairly tolerant to mutations resulting in single amino acid changes, increasing the number of substitutions additively increases the probability that the protein will be inactivated (Guo et al, 2004, Proc. Natl. Acad. Sci. USA 101: 9205-9210; pg 9209, right column, paragraph 2). Thus, making and analyzing proteins with up to 48 amino acid substitutions that also have TBRFV resistance activity would require undue experimentation.
Further assaying these proteins require transforming nucleic acids encoding them into S. lycopersicum plants, then exposing the resulting plants to TBRFV. Neither the specification or the art teaches an in vitro assay for this activity.
Thus, extensive teachings are required for making TBRFV resistance proteins with up to 48 amino acid substitutions relative to SEQ ID NO:116, as encompassed by the claims. These teachings are not provided for by the specification. The specification also fails to overcome the unpredictability in the art of making large numbers of amino acid substitutions in TBRFV resistance proteins as it provides no working examples of proteins with up to 48 amino acid substitutions relative to SEQ ID NO:116.
As the specification does not teach any S. lycopersicum plant or plant part comprising a gene encoding a TBRFV resistance protein with 95% identity to SEQ ID NO:116, undue trial and error experimentation would be required to screen through the myriad of proteins encompassed by the claims and plants comprising them, to identify those with TBRFV resistance, if such plants are even obtainable.
Given the claim breath, unpredictability, and lack of guidance in the specification as discussed above, the instant invention is not enabled throughout the full scope of the claims.
Conclusion
No claim is allowed.
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.
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/Anne Kubelik/Primary Examiner, Art Unit 1663
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