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 11-30 are pending and examined. Claims 1-10 have been cancelled.
The rejection of claim 8 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the cancellation of the claim.
Specification
The disclosure REMAINS objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g., p. 17). Applicant is required to delete all embedded hyperlinks and/or other forms of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Moreover, Applicant should note that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Finally, the specification references Figure “1a” and “1b” (¶ 040) even though there are no such designations in the figures.
Appropriate action is advised.
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.
Claims 11-30 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 making an Arabidopsis plant comprising the “3T3.3” allele to decrease weight gain in Spodoptera exigua, does not reasonably provide enablement for making and/or using the genus of plants comprising the genus of GLR3.3 having enhanced resistance to the genus of insect feeding as broadly claimed. 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/use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
The claims are broadly drawn to any plant species expressing a glutamate receptor-like protein (GLR3.3) having an undefined structure that provides a hypersensitive response (HR) to wounding resulting in enhanced resistance to insect feeding wherein said protein comprises a mutation in the calmodulin (CaM)-binding domain (CBD) within the cytoplasmic C-terminal domain (CTD) of the protein and wherein the mutation causes the plant to demonstrate attenuated or impaired Ca2+/CaM-mediated GLR3.3 channel desensitization compared to wild type protein . Thus, the claims define GLR.3.3 by function rather than structure.
Meanwhile, the specification teaches that four GLR3.3 mutant alleles of varying lengths were produced using CRISPR and that each of the alleles showed no difference in transcript level (¶ 040). Of the four, three showed loss of function but the “3.3T3” allele showed prolonged duration of wound triggered SWP implying that its CTD mutation led to GOF in enhancing SWP duration and did so even when complemented with wild type GLR3.3. (¶ 041 and 042).
Here, the specification fails to teach or provide working examples of the vast genus of plants that may express a GLR3.3 protein as broadly claimed, and further fails to teach or provide working examples of the genus of said plants comprising the genus of proteins which predictably have enhanced resistance to any conceivable feeding insect.
Moreover, the claims are directed to GLR3.3 that is defined by function rather than structure. Namely, not only do the claims fail to recite, in fact, the structure of the CBD in the CTD of the protein, the claims also fail to recite any other structural feature critical for GLR3.3 functionality, while the specification is completely silent regarding other structures found within GLR3.3 that confer functional activity.
Thus, the claims encompass an exhaustive genus of proteins that are claimed not by structure but rather function for which the specification has failed to provide a correlation, while the specification fails to teach or provide guidance for making and using an engineered GLR3.3 derived from any conceivable source.
Rather, the specification has provided one example: a “3.3T3” mutant allele in Arabidopsis. Moreover, outside of an unidentified five amino acid deletion (¶ 040), the specification fails to teach, in fact, the structure of GLR3.3 comprising a GOF mutation that enhances resistance to any conceivable insect that feeds on any possible plant.
This guidance is critical in light of the state of the art, which teaches that GLR3.3 mutant alleles in the CTD lead to loss of function of the protein supporting the notion that CTD may interact with other proteins required for GLR3.3. function (Yan et al, 2024, Nature Plants, 10:145-160; see p. 146, col. 2, ¶ 1 and 2). Thus, it is clear that not all CRISPR induced mutations in GLR3.3 will function as encompassed by the claims such that the skilled artisan would be unable to predictably make and use the genus of plants having HR as broadly claimed.
Or see Zhu et al, which teaches that overexpression of GLRs enhances anti-fungal defense but leads to severe growth inhibition possibly owning to constitutive JA signaling (2026, Plant Communications, 7:1-14; see p. 4, col. 2, penultimate ¶).
Regarding the genus of plants and their enhanced resistance to insect feeding, the specification has only taught that Spodoptera exigua gain less weight when feeding after 9 days (¶ 057) as opposed to teaching that the genus of plants as claimed have enhanced resistance to the equally exhaustive genus of feeding insects.
Guidance and working examples of the plants as claimed is critical because it is known in the art that insects employ an arsenal of salivary effectors to suppress plant immunity, including jasmonic acid defenses (Huang et al, 2026, Cell Reports, 45:1-18; see p. 1, col. 2). Or see Wu et al, which teaches that insects transmit plant viruses target JA signaling to promote the population of the insect vector (2020, Viruses, 12(148)1-16; see Abstract; see also p. 3, ¶ 1-3; see p. 7, last ¶).
As such, and in the absence of additional working examples, the skilled practitioner would be unable to predictably make the genus of plants as claimed in which there is enhanced resistance to insect feeding as broadly claimed.
Therefore, in light of the breadth of the claims, the failure of the specification to teach the structures within GLR3.3 that lead to GOF mutations, the lack of working examples, and the state of the art which reinforces that the majority of GLR3.3 mutants are not GOF and would not predictably enhance resistance to insect feeding, the skilled practitioner would be required to engage in a systematic screening process that is tantamount to excessive and impermissible undue trial and error experimentation to make the plants as broadly claimed.
Response to Arguments
Applicant traverses the rejection of the claims because the specification teaches unique regions in the GLR3.3 C-terminal domain play a dual role in systemic electrical signaling and because GLR channels are highly conserved across plant species (Applicant reply dated 17 July 2026, p. 1, penultimate ¶).
This argument is not persuasive as it is not commensurate in scope with what is claimed. Namely the specification has provided one example: a “3.3T3” mutant allele in Arabidopsis yet the claims are directed to GLR3.3 proteins having any structure and which are derived from any source such that teaching unique regions in the CTD is insufficient guidance for the skilled artisan to predictably make and use the claimed plants.
Applicant asserts that standard sequence alignments are sufficient to identify the CBD in other plant GLR homologs such that undue experimentation is not required to practice the invention (Applicant reply dated 17 July 2026, p. 1, last ¶ and p. 2, ¶ 1).
Applicant’s argument is unpersuasive because as provided in In Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 52 USPQ2d 1129 (Fed. Cir. 1999), the court held that two patents with claims directed to genetic antisense technology (which aims to control gene expression in a particular organism), were invalid because the breadth of enablement was not commensurate in scope with the claims. Both specifications disclosed applying antisense technology in regulating three E. coli genes. Despite the limited disclosures, the specifications asserted that the "[t]he practices of this invention are generally applicable with respect to any organism containing genetic material which is capable of being expressed … such as bacteria, yeast, and other cellular organisms." Thus, the court construed the claims to encompass the application of antisense methodology in a broad range of organisms.
Ultimately, the court relied on the fact that (1) the amount of direction presented and the number of working examples provided in the specification were very narrow compared to the wide breadth of the claims at issue, (2) antisense gene technology was highly unpredictable, and (3) the amount of experimentation required to adapt the practice of creating antisense DNA from E. coli to other types of cells was quite high, especially in light of the record, which included notable examples of the inventor’s own failures to control the expression of other genes in E. coli and other types of cells.
Thus, the teachings set forth in the specification provided no more than a "plan" or “invitation” for those of skill in the art to experiment using the technology in other types of cells. See MPEP 2164.06(b)(I).
Here, Applicant’s argument is no more than an invitation to experiment as (1) the specification fails to teach a structure function correlation for GLR3.3 for the protein to predictably attenuate or impair Ca2+/CaM-mediated GLR3.3 channel desensitization, the specification fails to provide working examples commensurate in scope with what is claimed, and the claims do not recite any particular structure for GLR3.3; (2) the state of the art, for example as taught by Wu, is unpredictable with respect to enhancing a HR to wounding by any conceivable insect; and (3) one would have to systematically test each and every variant of GLR3.3 as encompassed by the claims against a vast and diverse number of insects.
Applicant submits an expert declaration to support the aforementioned arguments (Applicant reply dated 17 July 2026, p. 2, ¶ 3).
This argument is not persuasive as the declaration merely recites Applicant’s arguments and because while factual evidence is preferable to opinion testimony, such testimony is entitled to consideration and some weight so long as the opinion is not on the ultimate legal conclusion at issue. While an opinion as to a legal conclusion is not entitled to any weight, the underlying basis for the opinion may be persuasive. In re Chilowsky, 306 F.2d 908, 134 USPQ 515 (CCPA 1962) (expert opinion that an application meets the requirements of 35 U.S.C. 112 is not entitled to any weight; however, facts supporting a basis for deciding that the specification complies with 35 U.S.C. 112 are entitled to some weight); In re Lindell, 385 F.2d 453, 155 USPQ 521 (CCPA 1967). See MPEP 716.01(c) III.
Here, the only evidence provided in the declaration are the results acknowledged by the Office, and the declaration contain legal conclusions without proffering any factual evidence (e.g., see Declaration dated 17 July 2026, sections 6 and 7).
Moreover, these results are not commensurate in scope with what is claimed because while the specification teaches that a single and specific mutated GLR3.3 protein attenuated or impaired Ca2+/CaM-mediated GLR3.3 channel desensitization, the specification fails to teach that the genus of mutated GLR3.3 proteins as encompassed by the claims have the same predictable function.
Applicant argues that mutants T1, T2 and T4 are negative controls and not mutations in the CBD (Applicant reply dated 17 July 2026, p. 2, ¶ 3).
This argument is not persuasive because as noted above it is not commensurate in scope with what is claimed. Here, the specification has provided one example: a “3.3T3” mutant allele in Arabidopsis yet the claims are directed to GLR3.3 proteins having any structure and which are derived from any source.
Moreover, there is (1) no evidence that T1, T2 and T4 are “negative” controls but instead appear to be mutations within the CaM-CBD of the CTD; and (2) each of T1, T2 and T4 are encompassed by the claims as they are mutations that lose almost the entire CTD and thus necessarily comprise a mutation in the CBD (e.g., see ¶ 040).
Claims 11-30 are 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.
Claims 11-30 are broadly drawn to any plant species expressing a GLR3.3 having an undefined structure that provides a HR to wounding resulting in enhanced resistance to insect feeding wherein said protein comprises a mutation in the CaM-CBD within the CTD of the protein and wherein the mutation causes the plant to demonstrate attenuated or impaired Ca2+/CaM-mediated GLR3.3 channel desensitization compared to wild type protein. Thus, the claims define GLR.3.3 by function rather than structure.
Meanwhile, the specification describes that four GLR3.3 mutant alleles of varying lengths were produced using CRISPR and that each of the alleles showed no difference in transcript level (¶ 040). Of the four, three showed loss of function but the “3.3T3” allele showed prolonged duration of wound triggered SWP implying that its CTD mutation led to GOF in enhancing SWP duration and did so even when complemented with wild type GLR3.3. (¶ 041 and 042).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Here, the specification fails to describe a representative number of species or structures from the broad genus of mutated GLR3.3 that retain functional activity leading to HR and enhanced resistance to insect feeding, and further fails to describe examples of the genus of said plants comprising the genus of proteins having enhanced resistance to any conceivable feeding insect.
Moreover, the claims are directed to GLR3.3 that is defined by function rather than structure. Namely, not only do the claims fail to recite, in fact, the structure of the CaM-CBD in the CTD of the protein, the claims also fail to recite any other structural feature of GLR3.3, while the specification is completely silent regarding other structures found within GLR3.3 that confer functional activity.
Rather, the specification has described one example: a “3.3T3” mutant allele in Arabidopsis. Moreover, outside of an unidentified five amino acid deletion (¶ 040), the specification fails to describe, in fact, the structure of mutated GLR3.3 that attenuate or impair Ca2+/CaM-mediated GLR3.3 channel desensitization to enhance resistance to any conceivable insect that feeds on any possible plant.
This description is critical in light of the state of the art, which describes that GLR3.3 mutant alleles in the CTD lead to loss of function of the protein supporting the notion that CTD may interact with other proteins required for GLR3.3. function (Yan et al, see p. 146, col. 2, ¶ 1 and 2). Thus, it is clear that not all CRISPR induced mutations in GLR3.3 possesses the function as encompassed by the claims such the skilled artisan would not be of the opinion that Applicant possesses the genus of GLR3.3 as broadly claimed.
Or see Zhu et al, which describes that overexpression of GLRs enhances anti-fungal defense but leads to severe growth inhibition possibly owning to constitutive JA signaling (see p. 4, col. 2, penultimate ¶).
Regarding the genus of plants and their enhanced resistance to insect feeding, the specification has only described that S. exigua gain less weight when feeding after 9 days (¶ 057) as opposed to describing that the genus of plants as claimed have enhanced resistance to the equally exhaustive genus of feeding insects.
A description of the plants as claimed is critical because it is known in the art that insects employ an arsenal of salivary effectors to suppress plant immunity, including jasmonic acid defenses (Huang et al, see p. 1, col. 2). Or see Wu et al, which describes that insects transmit plant viruses target JA signaling to promote the population of the insect vector (see also p. 3, ¶ 1-3; see p. 7, last ¶).
As such, and in the absence of additional working examples, the skilled practitioner would not be led to believe Applicant possesses the genus of plants as claimed in which there is enhanced resistance to insect feeding as broadly claimed.
Therefore, in light of the breadth of the claims, the failure of the specification to describe a representative number of mutated structures within GLR3.3 that attenuate or impair Ca2+/CaM-mediated GLR3.3 channel desensitization, the lack of working examples, and the state of the art which reinforces that the majority of GLR3.3 mutants would not predictably enhance resistance to insect feeding, the skilled practitioner would not be of the opinion that Applicant was in possession of the genus of plants as broadly claimed.
Response to Arguments
Applicant traverses the rejection of the claims for the same reasons as provided to overcome the scope of enablement rejection as in section 9 of the instant Office action (Applicant reply dated 17 July 2026, p. 2, penultimate ¶ bridging p. 3 and all of p. 3).
Therefore, these arguments are not persuasive for the reason as set forth above. Namely, Applicant has not described, in fact, a representative number of species from the exhaustive genus of mutated GLR3.3 proteins as encompassed by the claims, has not described, in fact, a representative number of species from the broad genus of plants comprising said mutated proteins, and has further failed to describe, in fact, a representative number of species from the vast genus of insects to which plants will have enhanced resistance to feeding.
Here, Applicant has only described a single species of a mutated GLR3.3 in a single species of plant arguably having enhanced resistance to one species of insect that feeds on said plant.
The fact that one can use standard sequence alignments to identify additional GLR3.3 proteins in plants (e.g., see Applicant reply dated 17 July 2026, p. 3, ¶ 2 and 3) addresses the issue of whether one may or may not predictably make and use the instant invention and thus satisfies the scope of enablement requirement, and has no bearing whatsoever with respect to whether the skilled artisan would be led to believe Applicant possesses the invention as broadly claimed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 11, 12, 14, 16-21 and 23-30 is/are rejected under 35 U.S.C. 102(a)(1) as being by Wu et al (2020, bioRxiv; 1-34; doi: https://doi.org/10.1101/2020.10.06.327924).
Instant claims 11, 12, 14 and 16-30 are drawn broadly an Arabidopsis plant expressing a GLR3.3 having a mutation in the CaM-CBD within the CTD of the protein, wherein the CBD corresponds to residues 867-888 of Arabidopsis, and methods comprising making or growing said plant.
Wu et al disclose truncated versions of GLR3.3 C-tail (3.3CT) including 3.3CT (850-883 aa) expressed in Arabidopsis plant that is grown and that the interacting residues are probably located in region 883-903 aa. Wu et al disclose site-directed mutagenesis in this area including mutations in three amino acids Arg884 (R884), Phe885 (F885) and Leu886 (L886) (p. 6, last ¶). These mutations overlap with the mutations of “T2” and “T3” as disclosed in the instant specification and thus necessarily comprise a mutation in the CaM-CBD within the CTD of the protein (e.g., see ¶ 0122).
Because there are no structural differences between the mutated GLR3.3 as disclosed by Wu et al and the plant comprising mutations as broadly claimed, it necessarily follows that the plant expressing an engineered GLR3.3 as disclosed by Wu et al will demonstrate attenuated or impaired Ca2+/CaM-mediated GLR3.3 channel desensitization compared to wild type protein and a HR response to wounding resulting in enhanced resistance to insect feeding, and will also have enhanced plant systemic wound signaling and anti-herbivore defense when it is made or grown.
Therefore, an Arabidopsis plant expressing a GLR3.3 having a mutation in the CaM-CBD within the CTD of the protein and wherein the mutation causes the plant to demonstrate attenuated or impaired Ca2+/CaM-mediated GLR3.3 channel desensitization compared to wild type protein and the plant has a HR response to wounding resulting in enhanced resistance to insect feeding, wherein the CBD corresponds to residues 867-888 of Arabidopsis, wherein the plant demonstrates increased expression of JA-responsive genes or prolonged or enhanced duration of wound slow wave potentials, and methods comprising making or growing said plant. is anticipated by Wu et al.
Claim Rejections - 35 USC § 103
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.
Claim(s) 11 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (2020, bioRxiv; 1-34; doi: https://doi.org/10.1101/2020.10.06.327924) and in view of Tyagi et al (2020, ACS Omega, 5, 20674-20683).
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 11 and 22 are drawn to a plant expressing a GLR3.3 having a mutation in the CaM-CBD within the CTD of the protein and wherein the mutation causes the plant to demonstrate attenuated or impaired Ca2+/CaM-mediated GLR3.3 channel desensitization compared to wild type protein and the plant has a HR response to wounding resulting in enhanced resistance to insect feeding, and wherein the plant is made using CRISPR.
Wu et al teach truncated versions of GLR3.3 C-tail (3.3CT) including 3.3CT (850-883 aa) expressed in Arabidopsis plant that is grown and that the interacting residues are probably located in region 883-903 aa. Wu et al teach site-directed mutagenesis in this area including mutations in three amino acids Arg884 (R884), Phe885 (F885) and Leu886 (L886) (p. 6, last ¶). These mutations overlap with the mutations of “T2” and “T3” as disclosed in the instant specification and thus necessarily comprise a mutation in the CaM-CBD within the CTD of the protein (e.g., see ¶ 0122).
Thus, while Wu et al teach a plant expressing a GLR3.3 having a mutation in the CaM-CBD within the CTD of the protein, the issue is whether one would have made said plant by instead using CRISPR. To this point, Tyagi et al teach that it was known in the art that CRISPR could be used to confer resistance to insect pests (see entire document) and is known the new breeding technology to combat insect pests and holds great promise because of its specificity, simplicity, efficiency and versatility by addressing key challenges posed by other genome editing tools (p. 20675, col. 1, ¶ 1; see also p. 20675, col. 2, penultimate ¶).
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to modify the method as taught by Wu et al by using CRISPR and Cas because of its known specificity, simplicity, efficiency and versatility that overcomes challenges posed by other genome editing tools.
One would have a reasonable expectation of success in doing so because Tyagi et al provides examples of the use of said system to predictably edit the plant genome for resistance to insect pests (e.g., see Table 2).
Conclusion
No claim is 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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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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