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 1-10 are pending and examined.
Specification
The disclosure is 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 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 8 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.
Claim 8 recites the limitation “GLR3.3-T3”. While the specification refers to “GLR3.3-T3” as a mutated GLR3.3 allele (¶ 040), the metes and bounds of the claim are indefinite because the limitation is not an art-recognized term and because the specification defines the limitation by function (¶ 052) rather than defining the structure of “GLR3.3-T3” such that one would not know what is or is not encompassed by the claims.
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 1-10 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 weigh 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) wherein said protein comprises a gain-of-function (GOF) mutation in the C-terminal domain (CTD) of the calmodulin (CaM)-binding domain (CBD). 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.
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 are GOF 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.
Claims 1-10 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 1-10 are broadly drawn to any plant species expressing a GLR3.3 having an undefined structure that provides a HR wherein said protein comprises a GOF mutation in the CTD of the CBD. Thus, the claims have defined GLR3.3. by function rather than any particular 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 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.
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 describe, 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 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 are GOF 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 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 not be of the opinion that Applicant was in possession of the genus of plants as broadly claimed.
Conclusion
No claim is allowed.
The claims appear to be free of the prior art. The closest prior art is Yan et al (2024, Nature Plants, 10:145-160) as addressed supra but which fails to reasonably teach, suggest or provide motivation for arriving at GLR3.3. with a GOF mutation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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, Bratislav Stankovic can be reached at (571)270-0305. 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.
/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
Prosecution Insights