DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on July 20, 2026, has been received and entered.
Claim Disposition
3. Claims 1-23 have been canceled. Claims 31-45 have been added. Claims 24-45 are pending. Claims 24-30 and 42-45 are under examination. Claims 31-41 are withdrawn as directed to a non-elected invention. The claims are only being examined to the extent that they pertain to the elected gene used in the method.
Information Disclosure Statement
4. To date no Information Disclosure Statement has been filed. Applicant is reminded of the duty to disclose.
Claim objection
5. Claims 24-30 and 42-45 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 24 is amended to recite “a method of reducing [[an amount of]] a plant pest, [[the method]] comprising: contacting the plant pest with a composition…… [[a Cas12a2 polypeptide or]] a polynucleotide encoding a CRISPR-associated 12a2 polypeptide (Cas12a2) ………[[or a polynucleotide encoding at least one guide polynucleotide]]; wherein each guide polynucleotide……. the one or more cells of the plant pest, wherein [[said]] the non-sequence-specific cleavage reduces the [[amount of the]] plant pest amount, size, weight, presence and fitness compared to [[the amount of the plant pest present upon contacting of the plant pest with the composition]] a corresponding plant pest that has not been contacted with the composition”. The dependent claims hereto are also included.
For clarity it is suggested that claim 44 is amended to read, “The method of claim 24, wherein….Cas12a2 polypeptide [[and the polynucleotide encoding the at least one guide polynucleotide are each]] is operably linked to…..”.
Appropriate correction is required.
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.
6. Claims 24-30 and 42-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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.
The claimed invention is directed to “a method of reducing an amount of a plant pest…. with contacting the plant pest with a composition comprising a Cas12a2 polypeptide or a polynucleotide…” (see claim 24 in its entirety). The invention of claim 24 does not describe “the amount” of plant pest that is reduced. There are no indicia in the claimed method of the mechanism of ‘contacting the plant pest with a composition’, such as is this orally administered to the plant pest via a spray of the pest or parts of the plants (i.e. leaves); or is the composition directly administered to the plant pests or is the composition administered indirectly from the plant cells to get to the pest cells. Thus, the claimed invention is not adequately described. In addition, the claimed invention encompasses a large variable genus of genes that could encode Cas12a2; a large genus of guide polynucleotide and hybridize to any target sequence in any pest cell (see claim 24 for example). With regard to the large genus of structures lacking adequate description in the claims, the art generally recognizes that several different DNA structures can encode the same protein. Thus the claimed invention is overly broad and not commensurate in scope with the disclosure in the specification. No correlation is made between structure and function for the coding sequence, and the claimed invention does not demonstrate possession of the large genus. The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
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 claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejection of record under 112, first paragraph remain but have been altered to reflect changes made to the claims.
The rejection under 112, first paragraph is traversed with applicant stating that at page 46-47 of the specification there is description of what an amount of a plant pest can refer to and how to select for a plant pest containing the composition. The plain meaning of reduced amount means less quantity, to make smaller, lower or less than before. With respect to reduced amount of a pest, the plain meaning is a lower population density or fewer individual pests present in a specific area. The instant claims are not limited and the specification provides an even broader definition by including size of pest, fitness of pest, viability of pest, weight of pest, presence of pest and number of pest and other characteristics that is said to affect presence and viability of the pest. In addition, contacting of the plant pest with the composition is also broad in the claims and can be construed in many different ways. The specification provides disclosure such as transfection, transformation and electroporation for instance, but again the claims are not limited. The limitations of the specification cannot be read into the claims; and the claims and the specification are clearly not commensurate in scope.
In addition, the claimed invention is generically directed to plant pest which is a large genus. Applicant points to some examples like Ex. 4 and 8 and FIG 3A and B, however, the art generally discloses that there is no single exact number of plant pest species globally but scientists have tracked tens of thousands of damaging insects, mites, nematodes and pathogens. Seemingly applicant has not demonstrated possession of the entire genus of plant pest (i.e. plant pest could be a spider, a mite, a worm, bugs, animals etc.), encompassed in the claims. Thus the rejection remains. Applicant is urged to contact the examiner for a discussion to reduce the remaining issues.
Conclusion
8. No claims are presently allowable.
9. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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