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 .
Status of Claims
The amendments submitted on July 1st, 2026 have been entered.
Claims 1-7, 9-15, 18-19, 21-22, and 24-25 are pending in the application.
Claims 9-15, 18-19, 21-22, and 24-25 were previously withdrawn.
Claims 1-7 are examined in this Office action.
The text of those sections of Title 35 U.S. Code, not included in this action, can be found in a prior Office action.
Informalities
Table 2 of the instant specification appears to display results for sugarcane cultivar UFCP84-1047, while this cultivar is denoted as energycane in the instant claims. This appears to be a typographical error.
Specification Objection
The objection to the specification is withdrawn in light of amendments to the specification.
Claim Objections
The objections of claims 1-7 in the office action mailed 04/06/2026 are withdrawn in light of amendments to the claims.
Amended claim 1, and claims 2-7 depending therefrom, are objected to for the recitation of “relative to expression or the one or more…” in line 4. This should be amended to recite “relative to expression of the one or more…”
Further, claim 1 recites “sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047” in line 5. This should be amended to recite “sugarcane cultivar CP96-1252 or energycane cultivar UFCP84-1047”, based on the alternative recitation of “[a]n engineered sugarcane or energycane plant” in line 1. These are new objections necessitated by amendments to the claims.
Claim Rejections under 35 USC § 112(a)
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.
Scope of Enablement
Claims 1-7 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 engineered sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047 plants having delayed flowering, wherein the engineered sugarcane or energycane plant has decreased expression of one or more FT4 gene, FT8 gene, or FT10 gene relative to expression of the genes in an unmodified engineered sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047 plant, does not reasonably provide enablement for any engineered sugarcane or energycane plant having delayed flowering, wherein the engineered sugarcane or energycane plant has decreased expression of one or more FT4 gene, FT8 gene, or FT10 gene relative to expression of the genes in an engineered sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047 plant. 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 or use the invention commensurate in scope with these claims. This is a new rejection necessitated by amendments to the claims.
In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: (1) the
quantity of experimentation necessary; (2) the amount of direction or guidance presented; (3) the presence or absence of working examples of the invention; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability or unpredictability of the art; (8) the breadth of the claim. In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988).
The instant disclosure teaches:
Sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047 plants engineered with RNAi constructs targeting FT4, FT8, and/or FT10 compared against a control of unedited sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047 plants.
CRISPR/Cas9 genetic editing of FT-genes in an unspecified sugarcane Saccharum spp. hybrid without comparison to CP96-1252.
The instant disclosure does not teach:
Any engineered sugarcane or energycane plant having decreased flowering, wherein the plant has decreased expression of one or more FT genes relative to sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047.
The claims are broadly drawn to any engineered sugarcane plant or energycane plant having delayed flowering, wherein the engineered plant has decreased expression of any FT4, FT8, or FT10 gene(s) relative to expression in sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047. The nature of the invention is the engineering of sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047 to delay flowering through inhibition of FT4, 8 and 10 genes when compared to a control sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047.
The working examples in the instant disclosure provide support for RNAi mediated suppression of conserved regions of exons from ScFT4, ScFT8, and ScFT10 [¶95], and CRISPR/Cas9 mediated co-suppression targeting sequences selected for ScFT4, ScFT8, and ScFT10 [¶96]. Example 5 enables suppression of flowering in sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047 with expression of RNAi suppression construct in comparison to non-modified sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047 [Table 2 and Table 3]. The tables do not provide data showing decreased expression of the genes in comparison to the control sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047. The Applicant has provided delayed flowering in a known cultivar with decreased expression of FT4, FT8, and FT10 genes in an RNAi construct when compared to those same cultivars that are unmodified.
In the art, FT genes are known as members of the PHOSPHATIDYLETHANOLAMINE BINDING PROTEIN (PEBP) family of proteins (Colleoni, P. et al. 2024. “Flowering time genes branching out.” Journal of Experimental Botany. 75(14): 4195–4200) [Abstract]. The regulation of flowering time is precisely times by the coordinated action of FT proteins and TERMINAL FLOWER 1 (TFL1) proteins. For members of the Poaceae family, including sugarcane and energycane, different growth types of have been selected for domestication based on sensitivity/insensitively to photoperiod for the initiation of flowering [pg. 4195, col. 1, ¶2]. Varieties can be photoperiod-sensitive or -insensitive; photoperiod-sensitive plants are characterized by accelerated flowering under long-day conditions.
To align the start of the reproductive phase with the environment, plants can sense different stimuli, such as day length (i.e. photoperiod) and temperature [pg. 4196, col. 2, ¶3]. Flowering is initiated when the external light input coincides with a sensitive phase of the circadian clock. Whether this happens under long days, short days, or both depends on the growth habit of the plant. In the model plant Arabidopsis, the floral regulators GIGANTEA (GI), CONSTANS (CO), and FT play key roles in the photoperiodic flowering responses. Although this pathway is highly conserved in plants, minor differences may occur between species. This demonstrates that the growth habit of the plant can drastically change the sensitivity and ability to perceive photoperiod depending on a plant’s growth habits. Additionally, FT transport is partially mediated via the direct interaction of FT with cellular membranes, which is a temperature-regulated process [pg. 4197, col. 2, ¶2]. Lower temperatures decrease FT expression, contributing another layer of control over the flowering time transition.
It is not guaranteed that the FT gene expression would be maintained across all sugarcane or energycane cultivars. For example, sugarcane cultivar CP96-1252 is an early flowering cultivar compared to other sugarcane cultivars (Vanweelden, M. et al. 2022. “Sugarcane Variety Census: Florida 2022.” Sugar Journal) [pg. 11, col. 3, ¶1], and therefore has different growth habits. Given the variable interplay between daylength and temperature with FT gene expression and the regulation of flowering time, using one cultivar, especially one documented as an early flowering cultivar, as a fixed reference against any engineered sugarcane plant would not provide consistent and reliable results.
Therefore, the art demonstrates unpredictability such that one of ordinary skill in the art would not be enabled to make or use the invention as claimed as features that would change the expression have not been taken into consideration.
Claim Rejections under 35 USC § 103
Claims 1-2 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kardailsky, I. et al. “Flowering Inhibition,” US Patent Application Publication No. US 20070192904 A1, published 08/16/2007 (as cited in IDS filed 12/31/2024), in view of Venail, J. et al. (2021), “Analysis of the PEBP gene family and identification of a novel FLOWERING LOCUS T orthologue in sugarcane,” Journal of Experimental Botany, 73(7):2035-2049 (as cited in IDS filed 12/31/2024), and Sandhu, H. et al. (2017). “Sugarcane Cultivars Descriptive Fact Sheet: CP 96 1252, CP 01-1372, and CP 00-1101.” IFAS Extension. SS-AGR-410. This is a new rejection necessitated by amendments to the claims.
Claim 1 recites an engineered sugarcane or energycane plant having delayed flowering, wherein the engineered sugarcane or energycane plant has decreased expression of one or more of the FT4 gene, the FT8 gene, and the FT10 gene relative to expression of the one or more FT4 gene, the FT8 gene, and the FT10 gene in sugarcane cultivar CP96-1252 and energycane cultivar UFCP84-1047.
Claim 2 recites the engineered sugarcane or energycane plant of claim 1, wherein the engineered sugarcane or energycane plant has decreased expression of the FT4 gene, the FT8 gene, and the FT10 gene.
Claim 5 recites the engineered sugarcane or energycane plant of claim 1, wherein the engineered sugarcane or energycane plant expresses one or more RNAi constructs targeting one or more of the FT4 gene, the FT8 gene, and the FT10 gene.
Claim 6 recites the engineered sugarcane or energycane plant of claim 5, wherein the engineered sugarcane or energycane plant expresses a single RNAi construct targeting one or more of the FT4 gene, the FT8 gene, and the FT10 gene.
Claim 7 recites the engineered sugarcane or energycane plant of claim 6, wherein the engineered sugarcane or energycane plant expresses a single RNAi construct targeting the FT4 gene, the FT8 gene, and the F T10 gene.
Kardailsky teaches the use of FLOWERING LOCUS T (FT) for modification of flowering, particularly flowering inhibition [Abstract]. Kardailsky teaches that flowering may be delayed by incorporating RNA interference (RNAi), an antisense nucleic acid or dsRNA or small interfering RNA (siRNA) (i.e. a plant having delayed flowering) [¶61 & 64]. Kardailsky teaches that the constructs and vectors of the invention may be incorporated into a variety of plants, including monocotyledons such as sugarcane (i.e. an engineered sugarcane plant) [¶55]. FT1, 2 and 3 were inactivated via RNAi in transgenics, TILLING, or identification and selective breeding to fix hypomorphic natural alleles in ryegrass (i.e. decreased expression of FT gene(s)) [¶83].
Kardailsky teaches RNAi constructs to inactivate the SVP gene and specifies that other RNAi-type constructs for the FT genes involved similar vector systems and experimental approach (i.e. plant expressing RNAi construct targeting FT gene(s)) [Fig. 6; ¶134]. Kardailsky teaches that the construct or vector may include one or more FT nucleic acids and that the nucleic acids within the same construct may have identical or differing sequences (i.e. a single construct targeting one or more FT genes) [¶48-49]. Kardailsky teaches that such system can be applied to any agricultural crop to facilitate more controlled production, and reduce dependence of yields on weather [¶66]. Thus, Kardailsky suggests the use of FT genes in delaying flowering.
Kardailsky does not teach that the FT genes are FT4, FT8, and/or FT10 genes. However, Venail teaches a comprehensive description of the phosphatidylethanolamine-binding (PEBP) gene family in sugarcane consisting of at least 13 FT-like genes and including key floral inducer genes, FT [Abstract]. Venail further teaches that there is a high degree of synteny between the diploid Sorghum and the basic sugarcane haplotype, thus making Sorghum a good model for sugarcane research [pg. 2036, col. 2, ¶4].
Six sugarcane FT-like genes, ScFT1-ScFT6, were previously identified (i.e. sugarcane FT4 gene) [pg. 0237, col. 1, ¶2]. Venail teaches novel sugarcane FT genes, ScFT7-13, ScMFT1, ScMFT2, and ScTFL2 from the Sugarcane Genome Hub database, Sucest-Fun database and from other RNA-seq experimental data (i.e. sugarcane FT8 and FT10).
To identify sugarcane homologues of known flowering-related genes, Blastx searches using the sugarcane transcriptome as queries were performed against a bait dataset of protein sequences from Arabidopsis thaliana, Sorghum bicolor, and Oryza sativa [pg. 2047, col. 2, ¶4]. ScFT8 and ScFT10 were identified and assigned its name to match the Sorghum homologue [pg. 2038, col. 1, ¶1]. Venail teaches that the FT-like genes show very high homology to their corresponding genes in Sorghum as expected, and also to other species, such as maize, rice, and Arabidopsis [pg. 2046, col. 2, ¶3]. Venail teaches that ScFT8 is phylogenetically grouped with sorghum SbFT8, which is able to induce flowering in the Arabidopsis ft-1 mutant [pg. 2043, col. 1, ¶2]. Venail teaches that ScFT10 shares a clade with ZCN8 from maize, which has been shown to have floral inducing activity in Arabidopsis, and SbFT10 in sorghum, which has been shown to induce flowering in the ft-1 mutant in Arabidopsis [pg. 2043, col. 1, ¶2]. Venail teaches that previously identified ScFT4 is in the same phylogenetic clade as the rice Hd3a gene and the sorghum SbFT1 gene, both of which have been shown to be floral activators [pg. 2043, col. 1, ¶1].
Kardailsky and Venail do not explicitly teach that the engineered sugarcane plant having delayed flowering has decreased gene expression of one or more FT genes relative to the sugarcane cultivar CP96-1252, however, Sandhu teaches that CP96-1252 is a known and well used cultivar of sugarcane with an early flowering phenotype and resistance to orange rust [Table 1].
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to modify the engineered sugarcane plant of Kardailsky by decreasing expression of any of the ScFT4, ScFT8, or ScFT10 genes, as taught by Venail. It would have been prima facie obvious to one of ordinary skill to modify a popular early flowering sugarcane variety to maintain demonstrated resistance. One would have reasonable expectation of success in delaying flowering by specifically targeting any of these genes as they were known in the art and were several of a finite number of FT genes in sugarcane at the time of filing. One would have been motivated to do so as Kardailsky teaches that use of the FT genes allows for control over yield with less dependence on weather and Venail teaches that delaying flowering can increase sugar/biomass yields without increasing the use of land, water, or other inputs and is thus an environmentally attractive approach [pg. 2036, col. 2, ¶1]. As Kardailsky teaches RNAi constructs and teaches that a construct may include targeting more than one FT gene, this is taken to read on a single RNAi construct capable of targeting the three FT genes. One would expect decreased expression of a gene used in an RNAi construct relative to a control, given that such a construct prevents translation of specific mRNA into proteins. Thus, the expression of the FT gene in the engineered plant would be lower than that of the CP96-1252 based on the properties of RNAi constructs.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kardailsky, Venail, and Sandhu, as applied to claims 1-2, and 5-7 above, and further in view of Brower-Toland, B. et al. “Compositions and Methods for Altering Flowering and Plant Architecture to Improve Yield Potential,” US Patent No. US 11555201 B2, filed 10/18/2017, published 01/17/2023 (as cited in IDS filed 12/31/2024 under US Patent Application Publication No. US 2018/0105819 Al).
Claim 3 recites the engineered sugarcane or energycane plant of claim 1, wherein the engineered sugarcane or energycane plant has loss of function mutation in the FT4 gene, the FT8 gene, and/or the F T10 gene.
Claim 4 recites the engineered sugarcane or energycane plant of claim 3, wherein the loss of function mutation is a CRISPR-induced loss of function mutation.
Kardailsky, Venail, and Sandhu do not explicitly teach wherein the engineered sugarcane plant has loss of function mutation in the FT4, FT8, or FT10 gene or wherein the loss of function mutation is a CRISPR-induced loss of function mutation. However, Brower-Toland teaches constructs and vectors for attenuating and/or refining expression of a florigenic FT gene to produce an engineered plant [Abstract & ¶320]. Brower-Toland teaches that the FT transgene may comprise a target site for an endogenous RNA molecule that may target and trigger suppression of the FT transgene [¶49]. Suppression may include lowering, reducing, or eliminating expression levels of the mRNA and/or protein encoded by the target gene and/or transgene in a plant (i.e. loss of function mutation) [¶65]. Brower-Toland teaches that any method known in the art for site-directed integration may be used, such as RNA-guided nucleases [¶105]. Also provided are guide RNAs (e.g., CRISPR RNAs (crRNAs), trans-activating CRISPR RNAs (tracrRNAs), guide RNAs (gRNAs), single-guide RNAs (sgRNAs)) useful for methods of using RNA-guided nucleases. Brower-Toland teaches that site-specific insertion or integration of a transgene or construct may be achieved by site-directed integration of the insertion sequence into a plant genome to create the targeted insertion event at or near the site of the double strand break or nick (i.e. CRISPR-induced mutation). Brower-Toland teaches that transgenic plants of the invention may provide greater yield potential than wild type or control plants [Abstract].
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to modify the engineered sugarcane plant of Kardailsky by decreasing expression of any of the ScFT4, ScFT8, or ScFT10 genes, as taught by Venail, using the gene editing methodology of Brower-Toland. One would have reasonable expectation of success in targeting and decreasing any of these genes with CRISPR-induced loss of function mutation as the genes were known in the art as was the CRISPR mutation allowing for site-specific integration of a transgene or construct for gene suppression. One would have been motivated to do so as Kardailsky teaches that use of the FT genes, among other flowering-related genes, allows for control over yield with less dependence on weather, and Brower-Toland teaches that the suppression may provide greater yield potential.
Response to Applicant’s Arguments:
Applicant's arguments filed July 1st, 2026, have been fully considered but they are not persuasive. Applicant contends that Kardailsky fails to demonstrate delayed flowering via decreased expression of any gene. Applicant further argues that, with regard to the Venail reference, the art must be viewed as a whole for what it would have suggested to one of ordinary skill in the art. The Applicant contends that the disclosures of both Kardailsky and Venail teach that the function of FT-like genes cannot be predicted based on sequence similarity and that one skilled in the art would not have reasonable expectation of success in targeting any of the FT-like genes. The Applicant asserts that the Venail reference teaches away from modifying expression of FT4, FT8, and FT10. Lastly the Applicant contends that claims 3 and 4 are not obvious over the cited Brower-Toland reference as it fails to cure the deficiencies of Kardailsky and Venail.
Examiner respectfully disagrees.
Initially, it is noted that this is a new rejection necessitated by the claim amendments.
First, in response to applicant's arguments against the Kardailsky and Venail references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Second, with regard to Applicant’s assertation that Kardailsky fails to demonstrate delayed flowering via decreased expression of any gene, the Applicant points out that Kardailsky provides experimental evidence for one transgenic plant displaying a significant delay in flowering compare to the others and compared to the non-transformed control. This example is an RNAi construct for RgGI, an Ft-like related gene. Kardailsky is expressly reciting that the heading date was significantly later than the other plants [¶80], indicating that the RNAi construct altered the phenotype. As RNAi targets specific messenger RNA transcripts, leading to their degradation, or the prevention of their translation, this would necessarily lead to decreased gene expression. In response to Applicant’s argument that Kardailsky is cited for disclosing RNAi inactivation of FT1, FT2, and FT3, Kardailsky does not provide the results of the RNAi inactivation of FT3, but does suggest such a construct for decreasing expression of one or more FT genes [¶83]. Kardailsky further teaches that with use of the methods and materials of the invention, flowering may be accelerated or delayed [¶64]. It may be accelerated, for example, by incorporating additional copies of a sense nucleic acid of the present invention. It may be delayed, for example, by incorporating an antisense nucleic acid or dsRNA or small interfering RNA (siRNA) derived from the nucleotide sequences of the present invention.
Additionally, with regard to the Applicant’s assertion that Kardailsky failed to demonstrate delayed flowering via decreased expression of any gene, the claims do not recite that the delayed flowering is actually as a result of the decreased expression. The claims recite an engineered plant that also has decreased expression of one or more genes relative to a control. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Thus, Applicant maintains that Kardailsky teaches systems and methods applicable to creating an engineered plant with decreased expression of an FT gene through RNAi inactivation and suggests that such constructs and vectors may be incorporated into sugarcane [¶55].
Third, with regard to Applicant’s argument that, with regard to the Venail reference, the art must be viewed as a whole for what it would have suggested to one of ordinary skill in the art, the abstract of Venail specifically teaches a comprehensive description of the PEBP gene family in sugarcane, very high homology of these genes to corresponding genes in Sorghum, maize, rice and Arabidopsis, and the suggestion that ScFT3 is likely to play a role in floral induction in sugarcane, as might other sugarcane FT-like genes. Although the Applicant is correct to highlight sections of Venail that suggest unpredictability within the FT genes based on homology and phylogenetic groupings (see, Request for Reconsideration-After Non-Final Rejection filed 07/01/2026, pgs. 10-11], Venail has adequately provided a finite number of FT genes and implicated them in floral activation.
Venail provides FT genes that are good candidates for testing, as well as sufficient methodology such that one of ordinary skill in the art would be able to test other suggested ScFT genes, such as FT4, FT8, and FT10. One would have reasonable expectation of success in trying the different previously published genes given the available methodology. One would be motivated to functionally test the known FT genes in sugarcane as Venail teaches that delaying flowering can increase sugar/biomass yields without increasing the use of land, water, or other inputs [pg. 2036, col. 2, ¶1], thus demonstrating a pressure to delay flowering times in sugarcane with a finite number of solutions.
With regard to Applicant’s argument that Venail teaches away from Ft4, FT8, and, FT10, although expression of ScFT4 was not detected in the RNA-seq experiments, Venail teaches that the ScFT4 gene sequence was already published in the Sucest-Fun and/or NCBI database, indicating that the gene is sequenced but may need to be optimized to be functionally tested. Further, Venail teaches that SbFT8 and SbFT10, homologs to ScFT8 and ScFT10, have bee able to induce flowering Arabidopsis mutants while also causing some pleiotropic effects [pg. 2043, col. 1, ¶2]. This shows that the homologs are floral inducers and, as this was done with Sorghum homologs, pleiotropic effects were not observed with sugarcane ScFT8 and ScFT10. Venail suggests testing of both ScFT8 and ScFT10 to determine if they are floral activators. Venail provides a framework for functional testing that would be available to one of ordinary skill in the art without inventive effort.
In light of the above arguments, claims 3 and 4 remain rejected over Kardailsky and Venail, and further in view of Brower-Toland. This rejection is maintained.
Summary
Claims 1-7 are rejected.
Applicants’ 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 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.
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/EMILY K JOHNSON/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
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