DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
2. Claims 19, 20, and 22-42 are pending and examined.
3. The objection to the Drawings is withdrawn in view of Applicant’s amendments to the Drawings.
4. All rejections of claim 21 are moot in view of its cancelation by Applicant.
Claim Rejections - 35 USC § 112 - Indefiniteness
5. 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.
6. Claims 19, 20, and 22-42 remain 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.
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s argument submitted on February 17, 2026 was fully considered but it is not persuasive.
In claim 19, as instantly amended, is unclear what is meant by the step of “incubating the inoculated plant parts.” While the specification recites the step of “incubating the inoculated plants” (paragraph 59 on page 13), it does not mention nor clarify how one would “incubate a plant part” in the context of the claimed method. Neither would one of ordinary skill in the art be apprised as to how an inoculated plant parts, as opposed to a plant, could be incubated; particularly since the “identifying” step of claim 19 fails to clarify the relationship between the inoculated plant “parts” and the “one or more plants.”
Given that claims 20 and 22-42 depend from claim 19 and fail to recite additional limitations overcoming its indefiniteness, these claims are indefinite as well.
Claim 20 is indefinite is indefinite for the following additional reason. It is unclear to which plants the limitation “one or more plants” refers. The “producing” step of claim 19, which claim 20 appears to limit, does not recite “one or more plants,” and the “identifying” step of claim 19 already recites “identifying one or more plants that do not develop systemic symptoms.” For this reason, it is unclear how claim 20 limits the active steps of the method of claim 19.
Claim 27 is further indefinite because the term “the Solanum or Capsicum plant” renders the claim indefinite because it lacks sufficient antecedent basis in claim 19, from which claim 27 depends. As instantly amended, claim 19 does not recite a Capsicum plant.
Applicant argues that the amendments to the claims overcome the rejection (page 8 of the Remarks). This is not found to be persuasive. Applicant’s amendments are acknowledged and the rejection has been modified accordingly. However, the claims remain rejected as set forth in the modified rejection above.
Claim Rejections - 35 USC § 112(a)
7. 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.
8. Claims 19, 20 and 22-42 remain 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.
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s argument submitted on February 17, 2026 was fully considered but it is not persuasive.
Applicant claims a method for producing one or more cultivated tomato plants comprising resistance against a tobamovirus whose genome comprises at least 97% sequence identity to SEQ ID NO: 1, wherein the virus causes systemic symptoms in a Solanum lycopersicum plants homozygous for one or more Tm resistance genes of Tm1, Tm2, and/or Tm22.
Applicant describes the full-length SEQ ID NO: 1 as the genome of a new tobamovirus that can cause systemic symptoms in tomato plants homozygous for one or more of Tm1, Tm2, and/or Tm22 resistance genes (Sequence Listing; Examples 1 and 2). Applicant describes identifying a virus that causes mosaic symptoms in tomato plants homozygous for the Tm22 R-gene, and describes sequencing its genome (Example 1). Applicant describes inoculating tomato and pepper plants with the virus and confirming that all inoculated plants “showed symptoms and were therefore susceptible to virus.” Applicant concludes that the virus can “cause systematic symptoms on plants homozygous for Tm1 and/or Tm2 or Tm22” (Example 2; page 28).
Applicant does not describe any methods of producing a plant resistant to any virus, including one whose genome comprises a nucleic acid sequence having at least 97% sequence identity to SEQ ID NO: 1. The method that has been described and reduced to practice in Examples 1 and 2 involves inoculating tomato and pepper plants with the virus and confirming their susceptibility to it. This cannot be considered reasonably representative of the claimed methods.
Moreover, Applicant has not described the genus of tobamoviruses encompassed by the instantly claimed methods. Applicant has not described any tobamovirus genomes with the recited properties and comprising a nucleic acid sequence with 97% sequence identity to the instant SEQ ID NO: 1.
SEQ ID NO: 1 is 6,402 nucleotide long and the genus of sequences having 97% identity to it would comprise millions of species. Of that genus, the sole described species is the full-length SEQ ID NO:1. This is not sufficiently representative of the vast genus encompassed by the claims. Particularly since the only method in which the specification has used SEQ ID NO: 1 is the method of confirming the ability of the virus with said genome to overcome the resistance of plants homozygous for the known resistance genes.
Similarly, the specification has not set forth any structure or structures within SEQ ID NO: 1 or proteins encoded by it such that one of ordinary skill in the art would be able to envision the members of the claimed genus that are capable of overcoming the resistance produced by one or more of the recited genes.
This lack of description in the specification is consistent with the state of the art. The prior art appears silent with regard to the requisite structure-function relationship between tobamovirus genome and its ability to overcome the Tm gene-mediated resistance. A post-filing article Maayan et al teach that a tobamovirus capable of breaking Tm2-mediated resistance was discovered only in 2014; and while they teach several mutations that are potentially responsible for the resistance breaking, they also conclude as follows: “we note that the presence of these mutations does not prove that they are the cause of the resistance breaking, and therefore, future studies utilizing an experimental approach (e.g., site-directed mutagenesis of the TMV genome are required to investigate each mutation’s role with respect to Tm-22 resistance breaking” (Archives of Virology (2018) 163:1863-1875; pg. 1867, left col.; see also Abstract and Table 1). The viral genome taught in Maayan et al, GenBank Accession KT383474 (pg. 1864, right col.) appears to have 99.3% identity to the instant SEQ ID NO: 1 (see sequence search results against the GenEmbl database, Result 1). There is no indication in Maayan or any prior art references, however, that one would be able to determine the structure-function relationship for the claimed genus.
For these reasons, it is unclear whether at the time of filing, Applicant was in possession of the instant invention, as broadly claimed.
9. Claims 19, 20 and 22-42 remain 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.
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s argument submitted on February 17, 2026 was fully considered but it is not persuasive.
In re Wands, 858 F.2d 731 (Fed. Cir. 1988) lists the following eight factors for determining whether undue experimentation would be required to practice an invention: (1) quantity of experimentation necessary; (2) amount of direction or guidance supplied; (3) presence or absence of working examples; (4) nature of the invention; (5) state of the prior art; (6) relative skill of those in the art; (7) predictability or unpredictability or the prior art; (8) breadth of the claims.
Applicant claims a method for producing one or more cultivated tomato plants comprising resistance against a tobamovirus whose genome comprises at least 97% sequence identity to SEQ ID NO: 1, wherein the virus causes systemic symptoms in a Solanum lycopersicum plants homozygous for one or more Tm resistance genes of Tm1, Tm2, and/or Tm22.
Applicant teaches that the full-length SEQ ID NO: 1 is the genome of a new tobamovirus that can cause systemic symptoms in tomato plants homozygous for one or more of Tm1, Tm2, and/or Tm22 resistance genes (Sequence Listing; Examples 1 and 2). Applicant teaches identifying a virus that cause mosaic symptoms in tomato plants homozygous for the Tm22 R-gene, and describes sequencing its genome (Example 1). Applicant teaches inoculating tomato and pepper plants with the virus and confirming that all inoculated plants “showed symptoms and were therefor susceptible to virus.” Applicant teaches that the virus can “cause systematic symptoms on plants homozygous for Tm1 and/or Tm2 or Tm22” (Example 2; page 28).
Applicant has not enabled the invention as instantly claimed. Applicant has not described any methods of producing a plant resistant to a virus whose genome has at least 97% sequence identity to SEQ ID NO: 1. The only method that Applicant did reduce to practice involves inoculating tomato and pepper plants with the virus isolated by Applicant and confirming their susceptibility to it (see Examples 1 and 2). There is no indication in the specification that one would be able to apply those or any other teachings of the specification to predictably identity a resistant plant, using the steps of the claimed method.
Moreover, in addition to not having taught how to practice the claimed method using a virus whose genome comprises the full-length SEQ ID NO: 1, has not taught how to practice the method using any nucleic acid sequence with 97% sequence identity to the instant SEQ ID NO: 1.
SEQ ID NO: 1 is 6,402 nucleotide long and the genus of sequences having 97% identity to it would comprise millions of species. Of that genus, Applicant has not taught any species that can be used in a method of identifying a resistant plant. For these reasons it would be highly unpredictable to attempt to practice the claimed invention. This conclusion is consistent with the state of the art.
The art related to tobamovirus resistance mediated by Tm1, Tm2, or Tm22 genes is limited and would not be sufficient to enable the claimed method. For example, as discussed in the written description rejection, above, Maayan et al, a post-filing article, teaches that a tobamovirus capable of breaking Tm2-mediated resistance was discovered only in 2014; and while they teach several mutations that are potentially responsible for the resistance breaking, they also conclude as follows: “we note that the presence of these mutations does not prove that they are the cause of the resistance breaking, and therefore, future studies utilizing an experimental approach (e.g., site-directed mutagenesis of the TMV genome are required to investigate each mutation’s role with respect to Tm-22 resistance breaking” (Archives of Virology (2018) 163:1863-1875; pg. 1867, left col.; see also Abstract and Table 1). The viral genome taught in Maayan et al, GenBank Accession KT383474 (pg. 1864, right col.) appears to have 99.3% identity to the instant SEQ ID NO: 1 (see sequence search results against the GenEmbl database, Result 1). There is no indication in Maayan or any prior art references, however, that one would be able to determine the structure-function relationship for the claimed genus or otherwise use it in a method of producing a resistant plant.
Given limited guidance supplied by Applicant, the breadth of the claims and the nature of the invention, as well as the unpredictability in the art, it would have required one skilled in the art undue trial and error experimentation to practice the claimed method.
Response to Arguments
With regard to both, the written description and the enablement rejections, Applicant cites the Declaration of Dr. Frank Millenaar, submitted on February 17, 2026, under 37 C.F.R. 1.132, and argues as follows: “Dr. Millenaar provides evidence of an experiment that produced a cultivated tomato plant comprising resistance against a tobamovirus whose genome comprises at least 97% sequence identity to SEQ ID NO: 1, using the methods described and claimed in the '484 application. See Millenaar Dec. at 11 7-12. Specifically, Dr. Millenaar explains that a cross between a resistant tomato plant and a cultivated tomato plant not comprising resistance to the tobamovirus resulted in a number of progeny plants having the resistance. Id. at 8-11. Therefore, Dr. Millenaar's declaration confirms that that-based on the teachings provided by the instant application-a person of skill in the art can produce cultivated tomato plants comprising resistance to the recited tobamovirus by identifying tomato plants comprising resistance against the tobamovirus and crossing the identified plant with a cultivated tomato plant not comprising resistance to the tobamovirus. Id. at 12” (page 9 of the Remarks).
This is not found to be persuasive. The Declaration of Dr. Millenaar submitted on February 17, 2026 under 37 C.F.R. 1.132 was fully considered but it is not sufficient to overcome the instant rejection.
It is unclear from the Declaration what tobamovirus sequence or sequences were used in the experiments described in paragraphs 7-11. For example, paragraph 8 discusses screening tomato germplasms for tolerance to “specific strain for the new tobamovirus whose genome comprises at least 97% sequence identity to SEQ ID NO: 1.” The identified tomato plant was subsequently bred with a cultivated tomato plant “not comprising resistance to the tobamovirus,” wherein some of the progeny showed resistance (paragraph 10; Table 1). However, the Declaration fails to identify the specific tobamovirus genomes against which the resistance was obtained: the phrase “at least 97% sequence identity to SEQ ID NO: 1” reflects a genus of sequences and it is unclear which specific members of that genus were used. The Declaration also states that ELISA was used to “exclude the presence of false negatives” (paragraph 8), but does not specify which antigens were actually screened for. It is thus impossible to evaluate whether the proffered evidence is commensurate with the scope of the claims or not with regard to the genus of tobamoviruses encompassed by the claims.
Moreover, the instant claims encompass not only crossing a resistant plant with a sensitive one, but also determining the presence of virus particles in the non-inoculated parts of the plant (see, for example, claim 30). The Declaration does not provide any data confirming the presence or absence of virus particles in non-inoculated parts of the screened plant. It is thus not commensurate with the scope of the claims in that respect. See MPEP 716.02.
Double Patenting
10. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
11. Claims 19, 20, and 22-42 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,124,848. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the patent are drawn to a method for identifying plants comprising resistance against a tobamovirus having at least 95% sequence identity to SEQ ID NO: 1 comprising inoculating one or more plat parts of the genus Solanum with an infections dose of the tobamovirus, incubating the plants, and identifying one or more plant that do not develop systemic symptoms. The steps of the dependent claims 2-21 of the patent appear to parallel the dependent claims of the instant application. SEQ ID NO: 1 of the patent has 100% identity to the instant SEQ ID NO: 1 (see sequence search results for SEQ ID NO: 1 against the Issued Patents database) and the “producing” step of the instant claim 19 would be made obvious by the steps recited in the dependent claims of the patent, such as “assessing symptoms” and “determining the presence of virus particles” on plants. For these reasons, the claims of the patent make obvious the invention of the instant claims.
Applicant states that Applicant intends to file a terminal disclaimer when allowable subject matter is identified (page 9 of the Remarks). The Examiner notes that no claims are currently allowable and thus the rejection is maintained.
Conclusion
12. No claims are allowed.
13. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRATISLAV STANKOVIC can be reached at (571)270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662
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