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 .
Claim Status
Claims 2-4, 8-10, 12, 15, 17, & 21-22 are under examination on the merits.
Claims 1, 5-7, 11, 13-14, 16 & 18-20 are canceled.
Priority
Claims 2-4, 8-10, 12, 15, 17, & 21-22 receive the
U.S. effective filing date of 22 October 2021.
Previous objection to the drawings is withdrawn in view of Applicant’s amendment to the specification.
Previous objection to the specification is withdrawn in view of Applicant’s amendment to the specification.
Previous rejection of claims 4-20 under 35 U.S.C. 112(b) for lack of recitation of active method steps is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 1-20 under 35 U.S.C. 112(b) for recitation of proteins of 90% identity is withdrawn in view of Applicant’s amendment to the claims.
Previous rejections of claims 1-20 under 35 U.S.C. 112(a), for lacking both possession and scope of enablement, in recitation of proteins of 90% identity is withdrawn in view of Applicant’s amendment to the claims.
Previous rejections of claims 4-20 under 35 U.S.C. 112(a), for lacking both possession and scope of enablement, for being drawn to general methods of breeding yield in any and all tomatoes is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 4-20 under 35 U.S.C. 101 for recitation of methods without describing further inventive steps is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 1-3 under 35 U.S.C. 101 for being directed to naturally occurring gene and/or its encoded protein, without describing further inventive steps, is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 4-20 under 35 U.S.C. 101 for being directed to a detecting or diagnosing the genetic state of an organism (i.e. a natural phenomenon), without describing further inventive steps, is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 1-3 under 35 U.S.C. 102(a)(1) as being anticipated by Wu is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 4-20 under 35 U.S.C. 102(a)(1) as being anticipated by Nie is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 4-20 under 35 U.S.C. 102(a)(1) as being anticipated by Gonzalez-Grandio is withdrawn in view of Applicant’s amendment to the claims.
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.
Claim 10 is 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.
Due to Applicant’s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 2 Mar 2026 as applied to claim 10. Applicant’s arguments 1 Jun 2026 have been considered but are not persuasive.
Claim 10 recites the limitation "a tomato" in line 1 but is dependent from claim 4 which lists different categories of tomatoes (i.e. ‘a tomato plant’ line 5; ‘a transgenic tomato plant’ line 6; ‘a transgenic tomato plant that overexpresses the BFNE protein’ line 7). Because it is unclear to which of the different categories the tomato in claim 10 is referring to, there is insufficient antecedent basis for this limitation in the claim.
Applicant is advised to amend language of claims 4 & 10 to specify ‘a recipient tomato plant’ and ‘the recipient tomato is a wild tomato’, where appropriate. This would remove any ambiguity surrounding interpretation of what constitutes a wild tomato plant, or what material is being referenced by the recited limitations. It is unclear, and debatable, if a ‘wild tomato’ which has undergone genetic modification remains categorized as ‘wild’ (i.e. not domesticated), or, if by virtue of genetic modification of a single gene, such resultant plants would be considered domesticated. Because this designation is a matter of subjective interpretation by the reader or any particular researchers’ opinion of what is required to distinguish wild germplasm from cultivars, extremely clear language is required to determine the metes and bounds of claim 10.
Response to Arguments
Applicant urges that amendment to claim 4 has resolved the previously raised issues of lack of antecedent basis in claim 10 [Remarks, p.9, ¶.1].
This is not persuasive because review of the amended claim language still presents an issue of indefiniteness due to the non-specific language of claim 10 and the presence of multiple objects in claim 4 which may be referenced. Moreover, the amended claims still leave room for variable interpretation based on the readers’ subjective consideration of what may constitute a ‘wild’ tomato.
Because this introduces ambiguity regarding the referenced subject, and potentially the scope of the encompassed material, claim 10 remains rejected.
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 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is merely directed to detecting or diagnosing the genetic state of an organism (i.e. a natural phenomenon).
The claims are drawn to a process, being methods of identifying wild tomatoes based on detection of BFNE using PCR.
This is a natural phenomenon (i.e. a product of nature) because the claimed gene being detected is naturally occurring in wild tomato germplasm and confers the phenotype of interest (i.e. branching and/or fruit production characteristics) in the instant application.
The claims do not recite additional elements that amount to significantly more than the judicial exception, as no further steps are included as limitations following the diagnosis of tomato germplasm. Applicant is merely diagnosing presence or absence of BFNE.
Applicant recites the use of PCR in diagnosing/detecting the wild-type allele, but this use of PCR in molecular diagnosis is routine, absent evidence to the contrary.
Claim 21 recites the additional element of a method of distinguishing wild and cultivated tomatoes. However, Applicant is merely pointing out two groups of tomatoes which naturally occur and can be diagnosed or distinguished as ‘wild’ or ‘cultivated’ based on a variety of naturally occurring features, including their genotype and presence of wild-type BFNE alleles. Thus, this claim is not directed to significantly more than a natural phenomenon.
Claim 21 also recites the additional element of detecting presence/absence of BFNE alleles using PCR and primers SEQ ID NO.6 & 7. However, this simply recites a method of molecular diagnosis or genetic screening for naturally occurring tomato allele(s). Thus, this claim is not directed to significantly more than characterizing a natural phenomenon (i.e. genetic screening or diagnosis).
Claim 22 recites the additional element of a gene used to differentiate wild and cultivated tomatoes being SEQ ID NO.3. However, SEQ ID NO.3 corresponds to the naturally occurring BFNE gene that differs between wild and cultivated tomatoes [Specification, p.12, ¶.1 & 6-7]. Thus, this claim is not directed to significantly more than characterizing a natural phenomenon (i.e. a naturally occurring tomato gene).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because Applicant does not modify or otherwise include any further inventive steps or modifications beyond detecting the naturally occurring BFNE. Applicant is simply performing a genetic diagnosis of BFNE, without describing modification or alteration of it beyond its naturally occurring state.
Such diagnosis of the phenotype of an organism using naturally occurring alleles, absent further applied steps, lacks integration into a practical application or inventive method. It is merely describing the natural world using the modern molecular toolbox.
Because of this, newly added claims 21-22 are rejected.
Response to Arguments
Newly added claims substantially repeat language drawn to identification of wild or domesticated plants based on the presence of BFNE from the previously rejected claims 4-20, which were also rejected for claiming a product of nature. The previously rejected claims have been canceled and/or amended.
Applicant has not remarked, or argued, the previous 101 rejection of claims 4-20 for this reason [see Non-Final Rejection, p.12, ¶.4—p.17, ¶.1], which have similar basis to the current rejection of newly added claims 21 & 22.
Applicant is silent as to the previously raised issues of claims being drawn to the mere diagnosis of the naturally occurring wild BFNE allele, which is clearly a product of nature, or natural phenomenon. Lacking response to address such rejection, newly added claims 21 & 22 are similarly rejected.
Conclusion
Claims 10 & 21-22 are rejected.
Claims 2-4, 8-10, 12, 15, 17, & 21-22 appear free of prior art.
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.
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.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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