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
In response to previous restriction requirement, applicant has chosen to elect Group I for examination, consisting of claims 20-28, without traverse.
Applicant elects the species of ‘C’ (both (A) and (B)) and elects SEQ ID NO:29 from claim 21, and, SEQ ID NO:25.
Claim Status
Claims 20-28 are under examination on the merits.
Claims 29-39 are withdrawn as drawn to non-elected subject matter.
Claims 1-19 are canceled.
Priority
Claims 20-28 receive the U.S. effective filing date of 1 Feb 2022.
Claim Objections
Claim 21 is objected to because of the following informalities:
Grammatical error; line 2 which reads “...Solanum plant comprising at least...” should read “…Solanum plant comprises at least…”. Appropriate correction is required.
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 27-28 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.
Claim 27 recites plants with increased yield ‘under temperature stress’. The broadest reasonable interpretation of ‘temperature stress’ as experienced by a crop plant is the magnitude of physiological disruption caused by change in temperature. This is determined not only by the physical temperature of the surrounding environment, but is also heavily influenced by the genetic background of the plant in question [Charkraborty et al. Plant Gene 37 (2024) 100439, p.7, col.1, par.5 – col.2 par.3]. For example, potatoes which are in the genus Solanum are typically more tolerant of cold weather, and less tolerant of hot weather, than chili peppers, which are also in the genus Solanum. What is a stressful temperature for a chili pepper may not be a stressful temperature for a potato and vice versa.
Moreover, within a crop species there will naturally exist genetic variation for cold and/or heat tolerance, and thus ‘temperature stress’ is often quite specific to crop, cultivar, and particular growing parameters or confounding environmental varaibles such as water availability [Sato et al. The Plant Journal (2024) 117,1873-1892, p.1875, Figure 1]. The claim does not indicate to what extent temperature must fluctuate, nor what level of physiological response is required, to determine if a plant is technically ‘under temperature stress’ and therefore encompassed by Applicant’s claim.
Looking to the specification for clarification, the only definitions of this loose construct provided by Applicant are (a) temperatures specific to Solanum lycopersicon [par.52-53, 204, 214] and (b) the statement that stress relates to production under ‘sub-optimal temperature’ [par.69]. It is unclear how (a) would inform the reader as to qualifying ‘temperature stress’ parameters in non-tomato Solanum species and/or how the bounds of ‘sub-optimal’ temperature would be defined in (b).
Because one would not be able to ascertain the metes and bounds of claim 27, or how to avoid infringing, both it and its dependent claim 28 are rejected as indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 20-28 are rejected under 35 U.S.C. 103 as being unpatentable over An [The Role of SIARF8 Transcription Factor in Tomato Fruit Development. PhD Thesis, University of Toulouse; Published 2020] in view of Vriezen [US2013/0145499A1; Published 6 Jun 2013], and Caruana [Plant Direct. 2020;001:1-16; Published 31 Aug 2020].
Claims are drawn to non-functional alleles of ARF8 which lead to parthenocarpy in tomato and increased abiotic (i.e. heat & cold) stress tolerance and pathogen resistance, conferred when native SlARF8a & SlARF8b are disrupted.
An teaches that disruption of ARF8a & ARF8b induces parthenocarpy in tomato [p.v, l.6-22]. They specifically teach that ARF8a & ARF8b in tomato are both involved in parthenocarpy, and demonstrate that disrupting these genes via gene editing leads to parthenocarpic tomato plants [p.42, par.1-2;p.55, par.2].
An does not characterize traits beyond parthenocarpy, such as yield or disease resistance. They do not describe the effect of temperature on tomato yield or fruit set.
Vriezen teaches that disruption of ARF genes can increase yield of tomato [par.259]. They teach the effect of non-optimal temperature on tomato fruit set and indicate that disruption of ARF genes can induce parthenocarpy, improving fruit set and increasing associated tomato yield [par.3-6, 9-12].
Caruana teaches that disruption of ARF genes can increase resistance to pathogens. They teach that wild-type expression of ARF, and overexpression of ARF, confer susceptibility to pathogens [p.7, col.1, par.2-3]. They teach that disruption of ARF genes using micro-RNAs, and that plants engineered to have reduced ARF function display improved disease resistance against biotic pathogens [p.5, col.1, par.1 – col.2, par.2; p.7, par.1].
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the ARF8 mutation system taught by An to produce parthenocarpic tomatoes with increased yield due to improved fruit set via disrupted ARF as described in Vriezen, and with improved disease resistance via ARF disruption as described by Caruana. An directly teaches the role of SlARF8a & SlARF8b in parthenocarpy, and their molecular characteristics.
An teaches genetically modified tomato plants inactive alleles of ARF8a & ARF 8b. Claim 20 recites two sequences comprising the ARF8a gene comprising SEQ ID NO.29 & 30, and limits the invention to a genome being devoid of the recited functional gene sequence of (i.e. wild-type) ARF8a. Applicant states these sequences comprise the active (i.e. wild-type) ARF8a. This indicates the sequences described in the claim (i.e. SEQ ID NO.29 & 30) are inherent to the functional, wild-type ARF8a. Similarly, Applicant describes SEQ ID NO.31 & 32 as comprising ARF8b (i.e. wild-type or active or functional), and claim language recites being devoid of the recited functional gene sequence.
The claim language of the instant application includes SEQ ID NO.29-32 as identifying of functional versions of ARF8a and ARF8b, which the claims then recite as the invention being ‘devoid of’. This indicates the claim limitations are drawn to genetically modified plants with inactive (i.e. ‘devoid of’) ARF8a and/or ARF8b, of which wild-type or functional allelic versions can be identified by possessing (i.e. comprise) SEQ ID NO.29-32. Thus, the recited sequences are not descriptive of Applicant’s mutations causing loss-of-function, but rather indicate a general absence of the functional or wild-type ARF8a & ARF8b alleles.
Though An does not refer to the exact sequences SEQ ID NO.29-32 recited as identifiers of ARF8a & ARF8b in the claim language of the instant application, such sequences used to characterize wild-type ARF8a & ARF8b would be inherent to the same genes of An’s research disclosure, which is directed explicitly to the ARF8a & ARF8b genes of tomato. One skilled in the art would recognize that any loss-of-function or deactivation of wild-type ARF8a and/or ARF8b would be encompassed by Applicant’s claims, as written, since the limitations are drawn to inactive ARF8a and/or ARF8b and genomes ‘devoid of’ ARF8a and/or ARF8b (capitalized notation indicates these are wild-type forms of the genes). Such loss-of-function or deactivation of ARF8a & ARF8b is one and the same as that taught by An.
It would be obvious to one skilled in the art that parthenocarpic tomato plants could be produced by modifying ARF8a & ARF8b, as pointed to by An. They would do so with reasonable expectation of altering fruit set & yield via ARF modification, as in Vriezen, and also potentially impacting disease resistance, as in Caruana.
One of ordinary skill in the art would be motivated to do this because it is known that reduced fruit set, including reduced fruit set due to non-optimal temperatures, is a yield-limiting factor in tomato. It is also known that diseases (generally) are a yield-limiting factor in tomato. One would be motivated to generate alternate forms of the parthenocarpic ARF mutant tomatoes reported by An to remove such environmentally-conditioned yield barriers and obtain higher-yielding, disease resistant tomato germplasm that would be valuable and productive.
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
/Anne Kubelik/Primary Examiner, Art Unit 1663
Prosecution Insights