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 .
Claim Status
Claims 1-19 are pending.
Claims 20-60 are cancelled.
Claims 1-9 are withdrawn as being directed to a non-elected invention. Claims 11 and 14-18 are further withdrawn as directed to a non-elected species, the species election having been made with traverse on 2/4/2026.
Claims 10, 12-13, and 19 have been examined.
Priority
This application is a 371 of PCT/US21/62321 12/08/2021
PCT/US21/62321 has PRO 63/126,087 12/16/2020
Withdrawn Objection and Rejection
The objection of claims 10 and 12 is withdrawn because the amendment to the claims overcome the objection.
All prior art rejections are withdrawn because the examiner reorganizes the prior art references of record in response to the claim amendments.
New Ground or Rejection
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 10, 12-13, and 19 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 10 is unclear with respect to the conflict steps (a) and (d) because it is unclear how an insect cell without a mouth of step (a) can orally update the RNA complex at step (d), rendering the metes and bounds indefinite. One of skilled in the art recognizes the route of “oral uptake” by way of a mouth. Throughout the life cycle of an insect, e.g., Diptera [00145], an insect may NOT have a mouth for eating. It is unclear if the proboscis of Diptera can be interpreted as “a mouth”. Neither the specification nor the claims distinctly define the route of “oral uptake”; thus, “oral uptake” the metes and bounds of “oral uptake” is unclear.
Furthermore, it is unclear for the term “insecticidal resistance ribonucleotide (RNA) molecule” in claim 10. In one interpretation, the claimed RNA makes insect resistant to insecticidal treatment. On the other hand, the term is an insecticidal RNA, which provides toxic insecticidal activity against one or more insect pests. MPEP 2173.02 (I) states “During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Zletz, 893 F.2d at 322, 13 USPQ2d at 1322. For example, if the language of a claim, given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate.”
For prior art search purposes, the limitation of “insect cell in contact with the RNA complex via oral uptake” is interpreted broadly including feeding an insect with plants/food containing the RNA complex.
New Ground of Rejection
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
1. Claims 10, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over De Schrijver et al. (CA 3129553 A1, cited 2/25/2026) in view of Tomich et al. (WO 2020/198020 A1, cited in IDS).
Claim 10 is drawn to a method of introducing a compound comprising SEQ ID NO: 1 complexed with RNA into an insect cell of an insect pest comprising:
providing the insect cell;
interacting a cell-penetrating peptide of SEQ ID NO: 1 with an RNA;
placing the insect cell and the RNA complex in contact with each other;
allowing uptake of the RNA complex into the insect cell via oral uptake of the RNA complex;
wherein the RNA complex provides toxic insecticidal activity against one or more insect pests
De Schrijver et al. teach “control of insect pests using RNA molecules” (Title). De Schrijver et al. teach the method comprises introduction of an interfering RNA molecule comprising a double-stranded RNA (dsRNA) or its modified forms such as small interfering RNA (siRNA) sequences, into cells or into the extracellular environment, such as the midgut, within a pest insect body wherein the dsRNA or siRNA enters the cells and inhibits expression of at least one or more target genes and wherein inhibition of the one or more target genes exerts a deleterious effect upon the pest insect. It is specifically contemplated that the methods and compositions of the invention will be useful in limiting or eliminating pest insect infestation. De Schrijver et al. further teach delivery of may be through production of the interfering RNA in a transgenic plant, by topically applying a composition comprising the interfering RNA to a plant or plant seed, or through contacting the insect with the interfering RNA, such as when the insect feeds on plant material comprising the interfering RNA. The interfering RNA may also be provided in an artificial insect diet which the insect then contacts by feeding (p4, line 3-23), reading on via oral uptake of the RNA complex.
De Schrijver et al. do not explicitly teach the use of a cationic peptide carrier to promote cellular uptake of RNA into cells.
Tomich et al. teach the use of linear peptides for creating colloidal particles and micelles for delivery of active agents (Abstract). Tomich et al. teach a preferred carrier is an amphipathic peptide comprising FLIVIKKKKK (100% identity to the instant SEQ ID NO: 1) or VLIVIKKKKK (p4, line 21-23; p17, Example 8) to deliver active agents comprising nucleic acids, other therapeutic agents, or radioactive labels (p4, 31-33). Tomich et al. teach highly cationic surface of the peptide particles resulting from oligo-lysine for efficient cellular uptake of nanoparticles (p10, last para to p11. para 1; p12, last para; p17, para 1). Tomich et al. teach delivering active agents to insects by contacting an insect (reading on insect cells) with colloidal particles carrying the active agent (p7, line 31-33). Because Tomich et al. teach advantages of the peptide carrier-nucleic acid complex comprising (i) easily disperse in aqueous solutions and fostering uptake by animal and plant tissues thereby facilitating the delivery of active ingredients to the interior of cells and (ii) the particles also shield the active agent from the external environment, which could prematurely inactivate the active agent. As drug delivery vehicles, the novel colloidal particles can also be used to alter the biological half-life of an active agent (p3, Description), one of ordinary skill in the art would have found it obvious to beneficially use Tomich’s amphipathic peptide comprising FLIVIKKKKK (100% identity to the instant SEQ ID NO: 1) as a carrier to deliver De Schrijver’s nucleic acid of dsRNA to facilitate the delivery of dsRNA into insect cells.
With respect to the limitation (b), Tomich et al. teach mixing an active ingredient (e.g., nucleic acid) with a carrier protein (p11, Example 3). Tomich et al. teach a preferred carrier is an amphipathic peptide comprising FLIVIKKKKK (100% identity to the instant SEQ ID NO: 1) or VLIVIKKKKK (p4, line 21-23; p17, Example 8) to deliver active agents comprising nucleic acids, other therapeutic agents, or radioactive labels (p4, 31-33). De Schrijver et al. teach the active agent is a double-stranded RNA (dsRNA) to limit or eliminate pest insect infestation, reading on interacting a cell-penetrating peptide of SEQ ID NO: 1 with De Schrijver’s dsRNA to generate dsRNA complexed with SEQ ID NO: 1.
With respect to the limitations (a) and (c)-(d), De Schrijver et al. in view of Tomich et al. teach delivery of dsRNA complexed with SEQ ID NO: 1 through contacting the insect with the dsRNA complexed, such as when the insect feeds on plant material comprising the interfering RNA. The interfering RNA may also be provided in an artificial insect diet which the insect then contacts by feeding (See De Schrijver et al. p4, line 3-23), reading on the limitations (a) and limitations (c)-(d).
With respect to the limitation (e), De Schrijver et al. in view of Tomich et al. teach addition of the dsRNA-SEQ ID NO: 1 complex on plant or feed of the contacted insect, reading on oral uptake of the complex of SEQ ID NO: 1 and dsRNA (See De Schrijver et al. p4, line 3-23).
One or ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine De Schrijver’s dsRNA with Tomich’s carrier of a polynucleotide to deliver nucleic acid because (a) De Schrijver et al. teach the use of dsRNA to control of insect pests (Title; p4, line 3-23) via plant/feeding and (b) Tomich et al. teach delivering active agents to insects by contacting an insect (reading on insect cells) with colloidal particles carrying the active agent (p7, line 31-33). Tomich et al. teach highly cationic surface of the peptide particles resulting from oligo-lysine (e.g., FLIVIKKKKK) for efficient cellular uptake of nanoparticles (p10, last para to p11. para 1; p12, last para; p17, para 1). Tomich et al. teach advantages of the peptide carrier-nucleic acid complex comprising (i) easily disperse in aqueous solutions and fostering uptake by animal and plant tissues thereby facilitating the delivery of active ingredients to the interior of cells and (ii) the particles also shield the active agent from the external environment, which could prematurely inactivate the active agent. As drug delivery vehicles, the novel colloidal particles can also be used to alter the biological half-life of an active agent (p3, Description). The combination would have reasonable expectation of success because both references teach delivery of a polynucleotide into insect cells.
With respect to claim 12, De Schrijver et al. teach the targeted insects comprise Coleopteran, Lepidoptera, Diplura, Anoplura, Trichopteran, and Siphonaptera [0105].
With respect to claim 19, De Schrijver et al. teach topically applying a composition comprising the interfering RNA to a plant or plant seed, through contacting the insect with the interfering RNA, such as when the insect feeds on plant material comprising the interfering RNA (p4, line 16-17 and line 21).
Response to Arguments
Applicant's arguments filed 4/20/2026 have been fully considered but they are not persuasive because the arguments are not applied to the new ground of rejection based on Schrijver et al. in view of Tomich et al.
2. Claims 10, 12-13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over De Schrijver et al. in view of Tomich et al. as applied to claims 10, 12, 19 and further in view of
Ghosh et al. (J. Vis. Exp. 2018; (135), e57390, cited 2/25/2026).
Claim 13 is drawn to the insect cell as a Hemipteran insect cell.
Schrijver et al. in view of Tomich et al. teach delivery of a complex comprising SEQ ID NO: 1 bound dsRNA to insect cells via oral feeding as applied to claims 10, 12, and 19.
Schrijver et al. in view of Tomich et al. do not specify the insect cell as a Hemipteran insect cell.
PNG
media_image1.png
358
508
media_image1.png
Greyscale
Ghosh et al. teach “Double-stranded RNA Oral Delivery Methods to Induce RNA Interference in Phloem and Plant-sap-feeding Hemipteran Insects” for crop protection and pest management (Title and Abstract) as shown follows (p5, figure 1). Because Ghosh et al. teach Double-stranded RNA can be introduced into insect cells via oral delivery (feeding) consistent with Tomich et al., one of ordinary skill in the art would have found it obvious to feed dsRNA)-amphipathic peptide complex to a Hemipteran insect to inhibit the insect growth and/or kill the insect, reading on claim 13.
One or ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) De Schrijver et al. in view of Tomich et al. with Ghosh’s Hemipteran Insects because (a) Schrijver et al. in view of Tomich et al. teach delivery of a complex comprising SEQ ID NO: 1 bound dsRNA to insect cells via oral feeding and (b) Ghosh et al. teach “Double-stranded RNA Oral Delivery Methods to Induce RNA Interference in Phloem and Plant-sap-feeding Hemipteran Insects” for crop protection and pest management (Title and Abstract). The combination would have reasonable expectation of success because all references teach the use of polynucleotide (e.g., dsRNA) for insect management and crop protection as taught by Ghosh et al.
Response to Arguments
Applicant's arguments filed 4/20/2026 have been fully considered but they are not persuasive because the arguments are not applied to the new ground of rejection based on Schrijver et al. in view of Tomich et al.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIA-HAI LEE whose telephone number is (571)270-1691. The examiner can normally be reached Mon-Fri from 9:00 AM to 6:00 PM.
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, Melissa Fisher can be reached at 571-270-7430. 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.
/J.L/Examiner, Art Unit 1658
08-June-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights