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 .
This is a Final Office Action in response to amendment filed on April 20, 2026. Claim 5 is newly canceled. Claims 1, 2, 4, 8-11, 15-17, and 19 are amended. Claim 26 is newly added. Claims 1-4, 6-17, 19, and 24-26 are pending and examined on their merit herein.
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 1-4, 6-17, 19, and 24-26 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.
Claims 1 and 10-11 are rejected for the recitation of open alternatives “or BIN2”in a closed Markush group (“consisting of”). If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See MPEP 2173.05(h). Dependent claims 2-4, 6-9, 12-17, 19, and 24-26 are included in this rejection for their failure to correct the deficiency above.
Claims 2, 4, 8, 9, 15, and 17 are also rejected as being indefinite for the recitation of “at least one gene involved in the downstream signalling of BRL3” because it is not clear if it is the same gene recited in the Markush groups of the base independent claims.
Claim Rejections - 35 USC § 112
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 1-4, 6-17, 19, and 24-26 remain 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 overexpressing Arabidopsis BRL3 gene as set forth in SEQ ID NO: 1 under the control of Arabidopsis SUC2 promoter in an Arabidopsis plant, does not reasonably provide enablement for modulating a plant adaptation trait by specifically expressing the BRL3 pathway in the phloem of any plant species. 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 and/or use the invention commensurate in scope with these claims.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
The claims are broadly drawn to methods, and plants produced thereof, for modulating a plant adaptation trait, comprising specifically expressing the BRL3 pathway in the phloem of the plant.
The scope of the claims are broad because:
The scope of the term “BRL3” is broad since it encompasses “BRL3” having 90% nucleotide sequence identity to SEQ ID NO: 1.
The scope of the genes downstream to BRL3 signaling is still broad to encompass any genes represented by the arbitrary names BRL3, KIN7, ERD14 and BIN2. For example, Brassica napas has several proteins annotated as “KIN7-A” and others as “Kin-7B”, “Kin-7E”, or “Kin-7H”. It is not clear whether the arbitrary name “KIN7” includes all of KIN7-A, or all of KIN7-A and KIN7-B, -E, -H, or whether the overexpression is required for all of the genes or merely any one of them, and if so, which one. Similarly, rice has many proteins annotated as KIN-7A, C, E, J, K, etc. On the other hand, some genes that are recognized as orthologs of Arabidopsis gene, e.g., BIN2, are not named BIN2. For example, the wheat ortholog of AtBIN2 is called TaGSK3. It is unclear that if such names are also included in the claim; and if so, to what extent. In summary, while a person skilled in the art would recognize these arbitrary names in Arabidopsis thaliana, it appears these names would be interpreted as many other genes and proteins in different plant species.
The scope of “plant” is broad. Firstly, the claims are broad to include any plant as the source of the “BRL3” gene or “BRL3 pathway”. Secondly, the claims are broad to include any plant as to be “modified”.
The term “specifically expressing” is broad. The Specification states that “specifically expressing the BRL3 pathway in the phloem” of a plant may be considered as expression of the BRL3 pathway in the phloem and in a maximum number of three other plant tissues of said plant. However, the scope encompasses any relative ratio of the expression levels of “BRL3 pathway” compared with any other tissue, and the “maximum number of three” other plant tissue could be any other three tissues.
Compared with the broad scope of the claims, Applicant has provided enabling guidance for overexpressing the Arabidopsis BRL3 gene as set forth in SEQ ID NO: 1 under the control of Arabidopsis SUC2 promoter in an Arabidopsis plant (Specification, p. 67, “Results”). The BRL3 receptor is expressed “uniquely in the phloem companion cells” and results in increased primary root length (FIG. 3A, B), lateral root numbers (FIG. 3C) and bigger rosettes and elongated petioles in adult stage (FIG. 4A, B), etc.
However, Applicant has not provided any enabling guidance for expressing any of the genes represented by the arbitrary names BRL3, KIN7, ERD14 and BIN2. As discussed above, the genus of genes that could be interpreted as any of “BRL3, KIN7, ERD14 and BIN2” is broad in the context of any plant species encompassed by the claims. Applicant has not provided any enabling guidance for expressing any other “BRL3” genes for example having 90% sequence identity to SEQ ID NO: 1; in Arabidopsis phloem that results in any modulation of any “plant adaptation trait”; or any other promoter that could achieve the desired expression pattern and the physiological and morphological modification; or expressing the any of “BRL3, KIN7, ERD14 and BIN2” genes in other plants.
It is unpredictable whether any member of the broad genus of “BRL3, KIN7, ERD14 and BIN2” genes would have the claimed functionality when expressed in phloem; or any promoter, etc, in any plant species, to result in the claimed pattern of physiological and morphological modification.
For example, as discussed above, sequence similarity does not guarantee the functional activity (see Zheng et al., 2022, above). In another example, Ali teaches that BRI1 and its family members BRL1/3, BRL2, EMS1, and NILR1 that belong to the LRR-RLK family of RLKs, control distinct biological functions through a conserved BR signaling pathway. Ali teaches that the kinase specificity between BRI1 and GASSHO1 (GSO1) is allosterically regulated by merely two subdomains, raising a question of how different RLKs control distinct biological functions through their conserved kinase domain (KD). Engineered chimeric receptors with replaced S1 and S2 subdomains while no other chimeric receptor could induce BR signaling in bri1–301 mutants, some chimeric receptors such as RPK2BRI1-S1(E)S2 not only rescued bri1–301, but also achieved molecular phenotypes. (Ali, Plant Science (2025): 112531.) These results demonstrate that, at the time of Applicant’s filing, the knowledge regarding the structure and function of Arabidopsis BRI-related proteins, not to mention BRL3 or the broad genus of genes having 90% identity to SEQ ID NO: 1, are not adequately understood to reliably predict the diverse functional outcome when ectopically expressed.
Similarly, the physiological consequences of expressing the broad genus of “BRL3, KIN7, ERD14 and BIN2” genes are unpredictable. Zhang (Journal of Integrative Agriculture 2018, 17(9): 1959–1971) teaches that overexpression of GmBIN2 enhances tolerance to salt and drought in transgenic Arabidopsis and soybean hairy roots. However, Zhang also teaches that AtBIN2 has been shown to have a primary role in the BR signaling pathway and is not responsive to abiotic stress.
Moreover, “enzymes and other proteins involved in the biosynthesis and signaling of BRs are well understood from molecular genetics and phenotypic analysis in Arabidopsis thaliana; however, knowledge of the molecular functions of these genes in other plant species, especially cereal crop plants, is minimal.” (Zebosi, Plant Communications 5.9 (2024), Abstract). Zebosi further teaches that, despite the knockdown of all BRI1/BRL homologs, none of the RNAi transgenic maize lines showed the extreme dwarfism of bri1 single mutants from Arabidopsis or rice. This suggests that the signaling pathway between Arabidopsis and maize are not fully understood to be equivalent and “a need for mutant analysis in maize”. Similarly, overexpression of BdBRI1 in the Atbri1-5 background did not recover the mutant phenotype (p. 11), suggesting yet again the unpredictability of BR signaling pathway in different plant species based on the knowledge of Arabidopsis thaliana.
Thus, in view of the unpredictability associated with combinatorial substitutions in a protein, the lack of enabling guidance from either the instant disclosure or the art, and breath and diversity of the embodiments encompassed by the claimed genus, the lack of sufficient working examples, and the level of the art at the time of the invention, one of ordinary skill in the art must rely on undue trial and error experimentation to make and test the the broad genus of “BRL3, KIN7, ERD14 and BIN2” genes in diverse plant species under different choices of promoters, in order to make and/or use the invention within the full scope of these Claims.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
Response to Applicant’s Remarks:
Applicant argued that the specification “provides detailed description of the BRL3 gene and its corresponding protein, and of the genes and proteins acting downstream of BRL3, including their systematic names and corresponding SEQ ID NOs (1-6 and 11-12). Furthermore, the Examples provide ample evidence that phloem-specific expression of BRL3 drives various physiological adaptations to stress ranging from root hydrotropic responses and re-configuration of root architecture via induction of programmed cell death in root meristems under imposed osmotic stress to improved plant adaptive growth to elevated temperatures. Importantly, in addition to SUC2, analogous results were obtained with other phloem-specific promoters, namely PEARl, CALS7, CLASS and NAC86 (SEQ ID NO: 20, 21, 22, 23 and Figure 49). Finally, the specification provides guidance on identifying and functionally validating the genes acting downstream of BRL3, for example KIN7 (Figures 21A).”
This has been fully considered but not deemed persuasive.
Although the Specification provides the names and SEQ ID Nos for the Arabidopsis genes, Applicant is reminded the claimed scope encompass ALL plant species, not just Arabidopsis. Applicant has not addressed the issues of ascertaining the members of the broad genus of “BRL3, KIN7, ERD14 and BIN2” genes in the diverse plant kingdom.
Secondly, Applicant has not provided any support for expressing any gene other than AtBRL3. Merely identifying the “downstream genes” in one plant species, Arabidopsis thaliana, does not support the physiological outcome of expressing the broad genus of “BRL3, KIN7, ERD14 and BIN2” genes in the diverse plant kingdom.
At least for these reasons, the rejection is maintained.
Conclusion
No claims are 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 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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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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