Prosecution Insights
Last updated: April 19, 2026
Application No. 18/568,456

TOBAMOVIRUS PSEUDOVIRIONS FOR STABILISING SINGLE STRANDED RNA

Non-Final OA §101§102§103§112
Filed
Dec 08, 2023
Examiner
KELLY, ROBERT M
Art Unit
1638
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
UNIVERSITY OF CAPE TOWN
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
2y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allow Rate
671 granted / 906 resolved
+14.1% vs TC avg
Strong +24% interview lift
Without
With
+24.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
44 currently pending
Career history
950
Total Applications
across all art units

Statute-Specific Performance

§101
4.5%
-35.5% vs TC avg
§103
15.3%
-24.7% vs TC avg
§102
17.3%
-22.7% vs TC avg
§112
35.1%
-4.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 906 resolved cases

Office Action

§101 §102 §103 §112
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. Claims 1-19 are pending as amended 12/8/23 and are considered herein. Formalities: The specification of 12/8/23 is accepted, as amended. The drawings of 12/8/23 are accepted. The IDS of 2/27/24 has been considered and is signed-off upon, herein. Applicant’s priority is recognized to be to PCT/IB2022/055404, filed 6/10/22, and back to GB document 210392.8, filed 6/11/21. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 10 and 18-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 10 and 18 are drawn to the composition obtained from the method of Claim 1, however, Claim 1 is to the method of making, and thus it no longer exists once the composition is made. Thus, Claims 10 and 18 are outside the scope of Claim 1. Additionally, Claim 19 is to a method of eliciting an immune response, which uses the composition, and thus is outside the scope of Claim 1 because Claim 1 is complete when the composition is made . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claim s 1-3 and 5-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. The claim(s) recite(s) a method of forming a pseudovirion . This judicial exception is not integrated into a practical application because it occurs in nature . The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because : . The claims are directed to a method, which is a proper statutory category. Claim 1 recites “wherein the expressed tobamovirus coat protein interacts with the OriA sequence on the ssRNA to initiate encapsidation of the ssRNA by the tobamovirus coat protein, thereby forming a pseudovirion ”. This is a naturally-occurring phenomena. It should be noted that there is nothing in the definition provided by Applicant for “ pseudovirion ” to exclude the natural virus and its processes, from being encompassed the claims (p. 13 of the specification, penultimate paragraph). The claims fail to recite significantly more. To wit, the base claim requires providing at least one expression vector, which encodes a tobamovirus coat protein, and a ssRNA comprising the OriA , which are then expressed, resulting in the natural phenomena. However, these same additional limitations read on the virus itself, producing progeny viruses. Thus, there is not significantly more. Claim 2 requires operational linkage to regulatory sequences for expression. However, such occurs for the virus in nature. Claim 3 requires the ssRNA to encode, e.g., reporter gene, and such may be considered to be any protein encoded by the virus, as one could raise antibodies to the same, and use it to detect the presence of the protein. Claim 5: the natural virus itself contains ssRNA which could be the target of a molecular target assay, e.g., by antibody detection. Claim 6-7: present claim 7 requires only two nucleotides in the same order to meet the limitation, and thus, virtually any protein encoding sequence will meet the limitation. Claim 8: the process of recovering the particles is the basis of science, the isolation and characterization of substances, and thus, it is not significantly more. Claim 9: TMV is a tobamovirus occurring naturally with this process. Thus, the claims read on a naturally occurring phenomenon without significantly more, and is properly rejected as a judicial exception under this statute. Claim s 10-12 and 14-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) compositions that occur in anture . This judicial exception is not integrated into a practical application because all of the limitations read on the naturally occurring compositions . The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because Claim 10: The claims read on the pseudovirion obtained from the process of Claim 1 (addressed in the rejection above), and thus, result in a naturally occurring composition. Claim 11 is drawn to a diagnostic control composition, which comprises a pseudovirion of a tobamovirus coat protein, encapsidating the ssRNA which comprises an OriA , the ssRNA being detected by a molecular diagnostic assay, and serving as positive control. The control is self-defining and thus, it necessarily can serve as a positive control. Additionally the depending claims do not provide significantly more. Claim 18 adds a pharmaceutically acceptable carrier or adjuvant, and the water in the system may be a carrier, and any of the proteins of the virus or cell it is within, may be an adjuvant. Claim 12 requires the ssRNA to encode, e.g., reporter gene, and such may be considered to be any protein encoded by the virus, as one could raise antibodies to the same, and use it to detect the presence of the protein. Claim 14: the natural virus itself contains ssRNA which could be the target of a molecular target assay, e.g., by antibody detection. Claim 15 -16 : present claim 16 requires only two nucleotides in the same order to meet the limitation, and thus, virtually any protein encoding sequence will meet the limitation. Claim 17: TMV is a naturally occurring virus. Thus, the claims read on naturally occurring compositions and are properly rejected under this statute. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1-3, 5-7 , 9-12, and 14-18 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WIPO document WO 2015/118183 A1 to Krupp, et al . ; and Claim(s) 11-12 and 14-17 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by WIPO document WO 2015/118183 A1 to Krupp, et al . Claim s 1 , 10- 1 1 , and 18 : Krupp teaches the encapsidation of RNA in a rod-shaped virus-like particle, where the RNA comprises an origin of assembly for a rod-shaped RNA virus and a heterologous sequence. The virus protein may be from TMV, and requires the TMV OriA (p. 5, last paragraph). The ssRNA may be expressed by transcription (e.g., p. 16, last paragraph), and the coat protein may be expressed in vitro or in bacterial cells (p. 21, paragraph 3). Thus, they are both expressed, in the same laboratory, which is the broadest reasonable interpretation for co-expressed. The ssRNA is necessarily a diagnostic for the sequence it detects and a positive control for such. With regard to carriers, it is noted the compositions are maintained with buffers and in the presence of water, meeting the carrier limitation (e.g., Examples). Claim 2: the sequences need a promoter to make the mRNA and regulatory sequences for translation for the protein, inherently. Claim s 3 and 12: the RNA may comprise an mRNA encoding a sequence associated with disease, like bcr / abl , EGFR, and the like (p. 18, penultimate paragraph). Claim s 4 and 13: Claim s 5 and 14. the RNA may contain another coding sequence from a rod-shaped RNA virus (p. 18, penultimate paragraph). Claim s 6 and 15: HIV sequences are taught (e.g., Id.). Claim s 7 and 16: SEQ ID NO: 2 is taught (e.g., pp. 18-19, paragraph bridging), which contains at lest two nucleotides of present SEQ ID NO: 1, in the same order, and thus it does comprise a sequence of present SEQ ID NO: 1. Claim s 9 and 17: TMV is taught (e.g., p. 5, last paragraph). Claim Rejections - 35 USC § 103 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 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) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/118183 A1 to Krupp, et al . and WO 2015/011676 A1 to Rybicki, et al . As shown above, the various aspects are taught in Krupp, however, the aspect of a reporter gene being a member of Claim 4. Nor does Krupp teach to administer it for eliciting an immune response. However, the Artisan, interested in the use of pseudovirions , would be aware of Rybicki (e.g., TITLE). Rybicki teaches the production of similar pseudovirions in plant cells, and specifically recognizes the use of a construct encoding a reporter which may be, e.g., secreted alkaline phosphatase (e.g., p. 18, paragraph 4). With regard to administration to elicit immune responses, Rybicki teaches administration of similar pseudovirions to produce an immune response (e.g., Brief Description, last paragraph). Thus, in light of the teachings of Rybicki, the Artisan would utilize a marker including those of Rybicki, in the invention of Krupp, and produce the same constructs in plant cells, as it was shown coexpression could be had to produce pseudovirions . The Artisan would expect success, as the components are utilized for art-recognized purposes. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ROBERT M KELLY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0729 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F: 8a-5p . 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, FILLIN "SPE Name?" \* MERGEFORMAT Tracy Vivlemore can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-2914 . 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. FILLIN "Examiner Stamp" \* MERGEFORMAT ROBERT M. KELLY Examiner Art Unit 1638 /ROBERT M KELLY/ Primary Examiner, Art Unit 1638
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Prosecution Timeline

Dec 08, 2023
Application Filed
Feb 25, 2026
Non-Final Rejection — §101, §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+24.5%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 906 resolved cases by this examiner. Grant probability derived from career allow rate.

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