Status of the Application
This Office Action is in response to the Amendment and Remarks filed 23 July 2025.
The objections to the Specification are withdrawn in view of Applicant’s amendments. The Substitute Specification is accepted by the Examiner.
The rejection of record under 35 U.S.C. 112(b) of claims 10-14 is withdrawn in view of Applicant’s amendments to the claims.
The rejections under 35 USC 102 are withdrawn in view of Applicant’s amendments to the claims.
The rejection under 35 USC 103 is withdrawn in view of Applicant’s amendments to the claims.
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 7 and 15 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.
Claim 7 is indefinite because it depends from a cancelled claim. Hence, the metes and bounds of the claim are unclear.
At claim 15 remains rejected because “sequence” is indefinite because “sequence” is information and not a composition of matter. Applicant argues that the claim has been amended on page 7 of the Remarks. This argument is not found persuasive because the amendment to claim 15 does not overcome the rejection. The Examiner suggests -- comprising the sequence of SEQ ID NO: 2 --, to clearly designate that the invention is a composition of matter and not just information.
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, 3-5 and 8-14 remain 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.
Applicant claims a pest control method comprising incorporating an inhibitory against a histone acetyltransferase (HAT) in the body of an agricultural target insect pest in the order Hemiptera. The incorporating steps including ingestion, application, spraying and/or atomization of the inhibitor on the target pest (claim 8).
Applicant claim the pest control method wherein the inhibitor is an RNAi inducing compound, a nucleic acid construct (that) intracellularly produces an RNAi inducing compound, and antisense nucleic acid targeted at the transcript product of a gene (en)coding a HAT of the target pest or a ribozyme targeted at the transcript product of a gene (en)coding a HAT of the target pest. Applicant claims said method wherein the target HAT is (en)coded by a homologue of instant SEQ ID NO: 1 at least 90% identical thereto (claim 4). Applicant claims wherein the RNAi is a double-stranded RNA (dsRNA) encoded by instant SEQ ID NO: 2 or a homolog having a sequence identity of at least 90% to instant SEQ ID NO: 2 that reduces at least the reproduction and/or survival of a target pest.
Applicant claims an isolated polynucleotide (operably lined to a heterologous promoter or comprised on a plant transformation vector, comprising instant SEQ ID NO: 2, or having at least 90% sequence identity to SEQ ID NO: 2, or a complement of any of said sequences wherein a dsRNA comprising said sequence incorporated into the body of a Hemiptera pest reduces at least the reproduction and/or survival of said pest (claim 10).
Applicant claims a dsRNA having a survival and/or reproduction and/or development inhibitory effect on a Hemiptera pest and comprising between 250-600 nucleic acids in length (claim 15).
Applicant describes using the dsRNA encoded by instant SEQ ID NO: 2 to target the histone acetyltransferase (HAT) and inhibit reproduction and/or survival of the pea aphid Acyrthosiphon pisum.
Applicant only describes an Acyrthosiphon pisum HAT at instant SEQ ID NO: 1, a search of the prior art only showed evidence of a second aphid encoding HAT polynucleotide from Lipaphis erysimi (mustard aphid) having 87.9% sequence identity to instant SEQ ID NO: 1. Hence, Applicant does not describe the genus of homologues (claim 4, also claim 7 as directed to SEQ ID NO: 2) other than by function. See MPEP § 2163 which states that the claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
At claims 1, 3, 4, 8 and 9, Applicant only describes the “inhibitor” by its function that being targeting a histone acetyltransferase (HAT), claims 3 and 4 define what HAT the “inhibitor” targets. Hence, Applicant only describes the “inhibitor” by function but does not describe any structure/function relationship for the “inhibitor”. At claims 5-7, Applicant only describes the inhibitor by its function, in particular an RNAi inducting compound or a ribozyme.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed. See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424, 1433 (DC WNY 2003) which teaches knowing the "starting point" is not enough; that is little more than a research plan. The court held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112.
Applicant argues that the amended claim set provides a specific target, narrowly defines the HAT, and provides a narrowly defined dsRNA sequence (page 8 of the Remarks).
Applicant’s argument has been fully considered but is not found to be persuasive. As addressed above, neither Applicant nor the prior art has described the variation within the claimed genus, a dsRNA at least 90% identical to instant SEQ ID NO: 2. The genus would include modifying up to 37 bases of the 367 bases of instant SEQ ID NO: 2. The decision in AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. 111 USPQ2d 1780 (Fed. Cir. 2014) seems to be germane to the instant case. In Abbvie, an analogy is drawn between a claimed genus and a plot of land (see pages 1789-1791). Using this analogy, the Court offered that “[I]f the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it.” Similar to the analogy drawn in Abbvie, in the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010), the court (at page 1171) offered: [M]erely drawing a fence around the outer limits of purposed genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
Claims 1, 3-5 and 8-14 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 a pest control method comprising using an epi-ML or a iRNA comprising instant SEQ ID NO: 2 that targes/inhibits expression of a histone acetyl transferase (HAT) in a Hemiptera insect pest, does not reasonably provide enablement for any chemical inhibitor of HAT or homologues of instant SEQ ID NO: 2. 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 use the invention commensurate in scope with these claims.
In re Wands, 858F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) lists eight considerations for determining whether or not undue experimentation would be necessary to practice an invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
Applicant claims a pest control method comprising incorporating an inhibitor against a histone aceyltransferase (HAT) in to the body of an insect belonging to the order Hemiptera said inhibitor reduces reproduction and/or survival of the insect. Applicant claims using homologues of instant SEQ ID NO: 1 (a p300 type histone acetyltransferase from Acyrthosiphon pisum) or homologues of instant SEQ ID NO: 2 encoding a RNAi molecule to said HAT encoding gene). Applicant claims an isolated polynucleotide and a plant transformed therewith (claims 10-14) comprising said homologues.
The art teaches (Kirfel et al 2020, published 2019) using dsRNAs to produce RNAi molecules to HAT genes in a Hemiptera insect, specifically A. pisum on page 10, paragraph 3.2. Kirfel et al teach that expression of the HAT dsRNAs all failed to reduce reproduction and/or survival of the “target pest”. Kirfel et al teach that “a growing number of studies report variable RNAi efficiencies in hemipterans ranging from no phenotype to significant effects on survival” (sentence spanning pages 16-17). Hence, given the breadth of the claims the limited guidance given, the nature of the invention and the unpredictability of the art it would have required undue trial and error experimentation to make and use the invention as broadly claimed. In Wyeth v. Abbott Laboratories, 107 USPQ2d 1273, at 1276-1277 (Fed. Cir. 2013), the court teaches that, the specification…discloses only a starting point for further iterative research in an unpredictable and poorly understood field, the resulting need to engage in a systematic screening process for each of the many rapamycin candidate compounds is excessive experimentation. The court thus held that there is no genuine dispute that practicing the full scope of the claims, measured at the filing date, required undue experimentation.
Applicant does not specifically address the instant rejection in the Remarks filed 23 July 2025. Consequently, the rejection is maintained for the reasons of record. It is the Examiner’s opinion that the claims as presently amended do not overcome the rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David H Kruse/
Primary Examiner, Art Unit 1663