Prosecution Insights
Last updated: August 06, 2026
Application No. 18/867,764

USE OF ENGINEERED JURONA VIRUS (JURV) AS AN ONCOLYTIC VIRUS PLATFORM FOR HUMAN CANCERS

Final Rejection §112
Filed
Nov 20, 2024
Priority
May 20, 2022 — provisional 63/344,395 +1 more
Examiner
ABBOTT, KODYE LEE
Art Unit
1634
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Bioventures LLC
OA Round
2 (Final)
58%
Grant Probability
Moderate
3-4
OA Rounds
1y 7m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
15 granted / 26 resolved
-2.3% vs TC avg
Strong +65% interview lift
Without
With
+64.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
31 currently pending
Career history
57
Total Applications
across all art units

Statute-Specific Performance

§101
4.4%
-35.6% vs TC avg
§103
37.8%
-2.2% vs TC avg
§102
19.1%
-20.9% vs TC avg
§112
34.3%
-5.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 26 resolved cases

Office Action

§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 . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This Action is in response to the papers filed on 04/30/2026. Claims 1, 2, 5, 7-10, 18, 20-22, and 57-61 are currently pending. Claims 1, 5, 7 and 10 have been amended and claim 4 has been cancelled by Applicant’s amendment filed on 04/30/2026. Election/Restrictions Group I, claims 1-2, 4-5, 7-10, and 18 (4 now cancelled), drawn to a construct comprising a promoter operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and a cell containing the construct, the sequences corresponding to SEQ ID NO: 1-5 (together) in claim 1, the sequence from claim 4 corresponding to SEQ ID NO: 6, and the sequence from claim 5 corresponding to SEQ ID NO: 11, in the reply filed on 10/07/2025, was previously acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 20-22, and 57-61 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. The requirement for restriction between Groups I-IV was previously made final. Therefore, claim 1-2, 5, 7-10, and 18 are currently under examination to which the following grounds of rejection are applicable. Priority The instant application is a 371 of PCT/US2023/067252 filed 05/19/2023, PCT/US2023/067252 claims priority to provisional application PRO 63/344,395 filed 05/20/2022. Thus, the earliest possible priority for the instant application is 05/20/2022. Withdrawn Rejections in response to Applicants’ arguments or amendments Claim Rejections - 35 USC § 112(b) The rejection of claims 1-2, 5, 7-10, and 18 under 35 USC § 112 (b) is withdrawn in view of the amendments in the response filed on 04/30/2026. Maintained and modified rejections in response to Applicants’ arguments or amendmentsClaim Rejections - 35 USC § 112 The following 112(a) rejections are modified as necessitated by the amendments filed on 04/30/2026. Claims 1-2, 5, 7-10, and 18 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 construct comprising a T7 promoter operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NO: 12 (JURV-XN-2) comprising SEQ ID NOs: 1-5 (elected species of codon optimized ORFs encoding 5 individual viral proteins),; and mammalian cells comprising said construct, does not reasonably provide enablement for a promoter system beyond the exemplified t7 promoter, multiple genomic organization of 1-5, sequences having 95% identity to SEQ ID NO: 12 or a genus of constructs allowing production of a negative sense viral genome when transfected into mammalian cells. 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. The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the patent coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is not based on a single factor but is rather a conclusion reached by weighing many factors (See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter, 1986) and In re Wands, 8USPQ2d 1400 (Fed. Cir. 1988); these factors include the following: Scope of the invention A construct comprising a promoter capable of supporting the claimed functionality of producing negative sense viral genome when transfected into mammalian cells that is operably linked to a polynucleotide comprising the sequences of SEQ IDs NO: 1-7, wherein the sequences of SEQ ID NOs:1-5 are flanked upstream by the sequence of SEQ ID NO:6 and downstream by the sequence of SEQ ID NO:7, and further comprises the sequence of SEQ ID NO:12 or sequences having at least 95% identity thereto.Number of working examples and guidance With respect to claim 1 and 4, the instant specification provides support for a construct comprising the T7 promoter operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells, wherein the polynucleotide encoding the Jurona virus genome comprises SEQ ID NO: 12 (JURV-XN-2) comprising SEQ ID NOs: 1-5 (elected species of codon optimized ORFs encoding all 5 individual viral proteins in a 5’ to 3’ direction) (Pg. 34, full page). The specification does not reasonably provide enablement for promoter systems beyond the exemplified T7 promoter, multiple genomic organizations of SEQ ID NOs 1-5, or sequence variance encompassed by the claimed genus of sequences having at least 95% identity to the sequence of SEQ ID NO: 12. Further, the specification does not identify which sequence modifications within the claimed 95% identity genus preserve the claimed functional capability of allowing production of a negative sense viral genome when transfected into mammalian cells. Accordingly, although the specification demonstrates operability for certain specifically disclosed embodiments, the number of representative working examples is not commensurate with the breadth of the claimed functional genus. Guidance Provided by the Art The prior art was generally searched for Jurona Virus characterization, codon optimization of Jurona Virus proteins, and the requirements for a polynucleotide to successfully encode a full length antisense Jurona virus genome that would function as negative sense viral genome when transfected into mammalian cells. The prior art demonstrates general reverse-genetics approaches for negative-sense RNA viruses and provides specific functional Jurona virus sequence information. The prior art is silent on the entirety of which promoter systems beyond the exemplified T7 promoter retain operability for the claimed constructs. The prior art is silent on which genomic organizations of the sequences of SEQ ID NOs: 1-5 preserve the claimed functionality. The prior art is silent on which sequence variants within the claimed genus of sequences having at least 95% identity to the sequence of SEQ ID NO:12 would retain the ability to produce a negative sense viral genome when transfected into mammalian cells. Post filing art by Tesfay et al. (Tesfay MZ, Mol Ther Oncol. 2024) teaches a full length Jurona Virus genome to be 10,993 base pairs in length and further describes the full-length gene to contain nucleoprotein (JURV-N), phosphoprotein (JURV-P), matrix protein (JURV-M), glycoprotein (JURV-G), and RNA-directed RNA polymerase L protein (JURV-L) (page 2, Results, 1st Paragraph). These Jurv proteins are encoded by codon optimized sequences of the instant application, SEQ ID NO: 1-5 (Pg. 2, 1st full paragraph of instant specification) and together total 10,680. The teachings of Rose et al. (US 2005/0238656 A1) and GenBank (GenBank Accession No. HM566194 "Jurona virus, complete genome) provided below are adopted from page 5 of the INTERNATIONAL SEARCHING AUTHORITY, International Search Report and Written Opinion for corresponding International Patent Application No. PCT/US2023/067252, mailed November 3, 2023, 18 pages. Of record, IDS filed on 11/20/2024. - Rose et al. discloses a construct comprising a promoter operably linked to a polynucleotide encoding a full length antisense vesiculovirus genome and allowing production of a negative sense viral genome when transfected into mammalian cells (para [0031]-[0033], [0047]) . Further, Rose et al. teaches a Jurona Virus to genus of vesiculovirus that can be made recombinant and further describes that “Any DNA that can be transcribed to produce vesiculovirus antigenomic ( +) RNA (complementary to the VSV genome) can be used for the construction of a recombinant DNA containing foreign DNA encoding an Antigen, for use in producing the recombinant vesiculovirus of the invention. DNA that can be transcribed to produce vesiculovirus antigenomic ( +) RNA (such DNA being referred to herein as "vesiculovirus (-) DNA") is available in the art and/or can be obtained by standard methods. (Pg. 4, Table 1; Paragraph [0045]). However, Rose does not teach a full length Jurona virus sequence. GenBank Accession No. HM566194 "Jurona virus, complete genome” (of record IDS filed on 11/20/2024; hereinafter 'HM566194') discloses a Jurona virus genome (pg 1 - "DEFINITION Jurona virus, complete genome.") comprising sequences similar to SEQ ID NOs: 1-5. However, neither Rose nor HM566194 identify conserved sequence requirements, permissible sequence variation, or predictive structural features sufficient to allow one of ordinary skill in the art to determine which of the broadly claimed functional genus would remain operable. In relation to the claimed genus of promoters operably linked to a polynucleotide encoding a full length antisense Jurona virus genome to allow production of a negative sense viral genome when transfected into mammalian cells, one of ordinary skill in the art would readily appreciate that a multitude of promoters were available for use in gene therapy constructs, but selection of a particular promoter depends on the detailed goal of the system and at least in part, on previous examples of promoters used successfully with a particular gene and transfected type of cell. Moreover, transcriptional activity of promoters is specific to the type of promoter used and transformed host cells with specific transcription factors. There is unpredictability in using a genus of promoters operably linked to a polynucleotide encoding a full length antisense Jurona virus genome and allowing production of a negative sense viral genome when transfected into mammalian cells. The teachings in the specification are directed to using a T7 promoter to express a full length antisense Jurona virus genome in mammalian cells. Specifically, the Specification disclose using plasmids to express the antigenomic sense RNA of JURV under the bacteriophage T7 promoter to generate recombinant JURV(Pg. 34, Lines 1-14). Moreover, the only exemplary promoter throughout the specification is T7 promoter (Pg. 4, Lines 1-4 and 23; Pg. 5 Lines 4-5 and 13-16; Pg. 15, Lines 29-31; Pg. 26, Lines 28-29).State of the art and unpredictability of the art Recombinant technology for the generation of new protein fragments is highly developed. However, the ability to determine a priori whether a polynucleotide encoding for a full length antisense Jurona virus genome comprising the nucleoprotein (JURV-N), phosphoprotein (JURV-P), matrix protein (JURV-M), glycoprotein (JURV-G), and RNA-directed RNA polymerase L protein (JURV-L) identified as SEQ ID NOS 1-5, in any order will generate a functional polynucleotide is not. Further, the is no specific art teachings to which sequence modifications within the claimed 95% identity genus preserve the claimed functional capability of allowing production of a negative sense viral genome when transfected into mammalian. There is also unpredictability in using any promoter for transcriptional expression in mammalian cells. The art must therefore be considered to be poorly developed. Amount of Experimentation Required In view of the unpredictability of the art, the poorly developed state of the art with regard to predicting the structural/ functional characteristics of the Jurona virus genome comprises SEQ ID NOs: 1-5, and that the specification provides only limited operative examples and insufficient guidance identifying which promoter systems, genomic organizations, and sequence variants across the claimed scope would retain the claimed functional property of allowing production of a negative sense viral genome when transfected into mammalian cells. Accordingly, one of ordinary skill in the art would have been required to engage in undue experimentation to practice the full scope of the claimed invention. Additionally, claim 1 encompasses sequences having at least 95% identity to the sequence of SEQ ID NO:12 (see also written description rejection below). The specification does not provide sufficient guidance identifying which substitutions, deletions, or sequences modifications within this broad genus preserve the claimed functional property. The specification likewise does not provide representative examples spanning the breadth of the claimed sequence-identity genus. Accordingly, undue experimentations would have been required to determine which variants remain functional within the scope of the claims. Claims 1-2, 5, 7-10, and 18 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 Claim 1 as amended recites “A construct comprising a promoter operably linked to a polynucleotide comprising SEQ ID NOs: 1-7,” wherein the construct allows for production of a negative sense viral genome when transfected into mammalian cells, wherein SEQ ID NOs: 1-5 are flanked upstream by SEQ ID NO: 6 and flanked downstream by SEQ ID NO: 7, or wherein the polynucleotide comprises SEQ ID NO: 12 (JURV-XN-2) or a sequence having at least 95% identity to SEQ ID NO: 12. As written, the polynucleotide may comprise up to 5% mismatched nucleotides at any location with respect to SEQ ID NO: 12. The specification has not adequately described the genus of sequences for the following reasons: Species described in the specification As stated in the applicants’ response filed on 04/30/2026 at Pg. 8, The specification shows possession of the specific order of SEQ ID NOs: 1-5 in the polynucleotide, as described above and acknowledged by the Office. The specification also discloses helper plasmids encoding JURV-P, N, and L, which allowed for rescue of the virus, also as described above. The application further discloses that "it should be understood that the order of the JUR V genes may be altered, though this may result in decreased production of virus" (pg. 16, lines 25-26).” GenBank Accession No. HM566194 "Jurona virus, complete genome” (of record IDS filed on 11/20/2024; hereinafter 'HM566194') discloses a Jurona virus genome (pg 1 - "DEFINITION Jurona virus, complete genome."). However, based on the genome the provided genome and following a search in the art, the identity and location of which polynucleotides could be altered and which polynucleotides could not be altered and still allow for a functional polynucleotide performing the claimed function and having 95% identity to the sequence of sequence ID NO: 12 remains elusive. The specification does not provide sufficient guidance identifying which substitutions, deletions, or sequences modifications within this broad genus preserve the claimed functional property. The specification likewise does not provide representative examples spanning the breadth of the claimed sequence-identity genus. Therefore, there is no guidance for the skilled artisan to prepare a polynucleotide for all species with less than 95% identity to SEQ ID NO: 12 that retains the claimed function of “production of a negative sense viral genome when transfected into mammalian cells”. Put another way, as the sequence of SEQ ID NO: 12 is 11318 nucleotides in length, the entirety of species represented by genus of “95% identity to SEQ ID NO: 12” would allow for polynucleotides where up to ~565 positions can vary with any of the 4 nucleotide sequentially or in any order. This would mean a potential 4565 possible variants when considering ONLY substitutions, not to mention insertions and deletions. In summary, the specification describes insufficient species within the claimed genus – a polynucleotide with 95% identity to SEQ ID NO: 12 that retains the claimed functionality. Guidance Provided by the Art A thorough search of the art is discussed in the enablement rejection above. The prior art failed to identify conserved sequence requirements, permissible sequence variation, or predictive structural features sufficient to allow one of ordinary skill in the art to determine which of the broadly claimed functional genus would remain operable. Taken together, the art fails to provide any additional species within the claimed genus. Conclusion Considering the large variation in the genus of the instant application, the minimal species described in the specification, and the lack of predictability provided by the specification and art for the full scope of the claimed genus, it is reasonable to conclude that Applicant did not possess the invention as claimed at the time of filing. Response to Applicants’ Arguments as they apply to the modified rejection of Claims 1-2, 5, 7-10, and 18 rejected for lack of enablement under 35 U.S.C. 112(a) At pages 7-8 of the remarks filed on 04/30/2026, Applicants essentially argue “…the specification contained sufficient information regarding the subject matter of the claims that one of skill in the art could produce a negative sense viral genome with SEQ ID NOs: 1-5 in no particular order and any suitable promoter capable of allowing for production of the negative sense viral genome when the polynucleotide was transfected into mammalian cells without undue experimentation. These arguments have been fully considered but have not been found persuasive. Applicants’ assert that “In regard to the order of SEQ ID NOs: 1-5, the Examples use a polynucleotide comprising from 5' to 3': a leader sequence, SEQ ID NOs: 1-5 in order, and a trailer sequence. However, the specification describes that in addition to the full-length genome, individual helper plasmids encoding JURV-P, N, and L were used to generate recombinant JURV, and virus was rescued (pg. 34, lines 11-14). Even though polynucleotides with SEQ ID NOs: 1-5 in different configurations may not have been used, individual plasmids were used and virus was rescued, this shows that an exact configuration of SEQ ID NOs: 1-5 is not required because viral proteins needed for viral production could be made via addition of plasmids to allow for adequate expression of viral proteins.” The claims do not require a specific internal orders of 1-5 relative to another, spacing relationships between 1-5, contiguous arrangement of 1-5, or a specific transcriptional organization for seq 1-5 within the construct. Accordingly, although the specification demonstrates operability for certain specifically disclosed embodiments, the number of representative working examples is not commensurate with the breadth of the claimed functional genus. Applicants’ further argue that “All that is required by claim 1 is that the promoter allow production of the claimed negative sense viral genome. Any promoter that is capable of performing this function is suitable. One of skill in the art would recognize that different promoters could be used, and it does not require undue experimentation to test different promoters and see if they allow production of the claimed polynucleotide. Further, the Office cited no evidence regarding the nature of unpredictability due to the type of promoter as required. For these reasons, the genus of promoters is enabled.” Applicants’ statements regarding the “All that is required by claim 1 is that the promoter allow production of the claimed negative sense viral genome. Any promoter that is capable of performing this function is suitable. One of skill in the art would recognize that different promoters could be used, and it does not require undue experimentation to test different promoters and see if they allow production of the claimed polynucleotide.” are not supported by evidence and are merely attorney arguments. Attorney arguments do not replace evidence where evidence is necessary, see MPEP 2145. Further, the lack of prior art with respect to what promoters would allow production of the claimed negative sense viral genome would support that the use and experimentation to determine a suitable promoter in terms of transcription activating factors in the host cell, timing, tissue specificity, length of the nucleotide construct to be expressed and expression levels would indeed require undue experimentation. Therefore, applicant’s arguments are not considered persuasive and the claims remain rejected. Response to Applicants’ Arguments as they apply to the modified rejection of Claims 1-2, 5, 7-10, and 18 rejected for lack of written description 35 U.S.C. 112(a) At Pages 8-9, applicant asserts “…the specification describes the claimed invention in sufficient detail that one of skill in the art can reasonably conclude that the inventor had possession of obtaining a functional full-length antisense Jurona virus genome with all possible variations of suitable promoter and orientations of SEQ ID NOs: 1-5.” These arguments have been considered but have not been found persuasive. Applicant provides the following 1. “The specification shows possession of the specific order of SEQ ID NOs: 1-5 in the polynucleotide, as described above and acknowledged by the Office. The specification also discloses helper plasmids encoding JURV-P, N, and L, which allowed for rescue of the virus, also as described above. The application further discloses that "it should be understood that the order of the JURV genes may be altered, though this may result in decreased production of virus" (pg. 16, lines 25-26).” and 2. “Further, in regard to the promoter, the promoter must allow for production of the claimed negative sense viral genome. Thus, the construct cannot have "any promoter" as stated by the Office. The Examples show that the T7 promoter allows for production of the negative sense viral genome. One of skill in the art would recognize that other promoters could be used to achieve the same purpose.” Regarding point 1, as discussed in the modified written description above (and especially in consideration of a construct with 95% similarity to the sequence of SEQ ID NO:12) considering the large variation in the genus of the instant application, the minimal species described in the specification, and the lack of predictability provided by the specification and art for the full scope of the claimed genus, it is reasonable to conclude that Applicant did not possess the invention as claimed at the time of filing. Regarding point 2, as applicant states with respect to the topic of promoters “Further, in regard to the promoter, the promoter must allow for production of the claimed negative sense viral genome. Thus, the construct cannot have "any promoter" as stated by the Office. The Examples show that the T7 promoter allows for production of the negative sense viral genome. One of skill in the art would recognize that other promoters could be used to achieve the same purpose.” Amended claim 1 remains broad in scope as the claim encompasses promoter systems beyond the specifically identified T7 promoter, provided such promoter systems satisfy the claimed functional capability. The claim provides no structural limitations defining which promoter systems are operable, nor does the claim provide predictive characteristics sufficient to determine which promoters across the full scope of the claim retain the claimed functionality. While the specification demonstrates operability for the specifically exemplified T7 promoter system, the specification does not provide representative working examples spanning the breadth of promoter systems encompassed by the claim. Moreover, the specification provides no guidance identifying promoter characteristics, transcriptional properties, or cellular expression conditions required to reliably support production of the claimed negative sense viral genome in mammalian cells. Applicants’ assertion that “One of skill in the art would recognize that other promoters could be used to achieve the same purpose.” Is unsupported by the representative examples or sufficient guidance demonstrating operability across the full scope of the claimed promoter genus. The issue is not whether additional promoters may function, but rather the specification provides reasonable support for the full scope of the claimed genus without undue experimentation. In view of the functional nature of the claims, the technical complexity of reverse-genetics systems for negative-sense RNA, and the lack of support within the specification for the breadth of the polynucleotide when considering the allowed 5% variance and promoter systems encompassed by amended claim 1, it does not appear the applicant had full possession of the invention as claimed. Thus, the claims remain rejected. New Grounds of Rejection in view of applicants’ amendments 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 1-2, 5, 7-10 and 18 are newly 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 applicant regards as the invention. This is a new rejection necessitated by amendment of the claims in the response filed 4/30/2026. Claim 1 is indefinite in its recitation of “or wherein the polynucleotide comprises SEQ ID NO: 12 (JURV-XN-2) or a sequence having at least 95% identity to SEQ ID NO: 12”. Claim 1 requires a polynucleotide comprising SEQ ID NOs: 1-7. SEQ ID NO: 12 appears to comprise SEQ ID NOs: 1-7. The Specification discloses in paragraph [0052] that “The construct may comprise SEQ ID NO: 12, also referred to as JURV-XN-2, which is a polynucleotide encoding the nucleoprotein (N), phosphoprotein (P), matrix protein (M), glycoprotein (G), and RNA-directed RNA polymerase L protein (L), that was codon-optimized for expression in mammalian cells”. A broad range or limitation is together with a narrow range of limitation that falls within the broad range or limitation (in the same claim) is considered indefinite since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. In the present instance, claim 1 recites the broad recitation “SEQ ID NOs: 1-7”, and the claim also recites specific polynucleotide sequences having 95% sequence identity to SEQ ID NO:12, e.g., SEQ ID NOs: 1-7, which is the narrower statement of the range/limitation. Claim 10 is indefinite in its recitation wherein the polynucleotide comprising SEQ ID NOs: 1-7 comprises SEQ ID NO: 13 (JURV-eGFP). It is unclear whether SEQ ID NO: 13 is in addition to NOs: 1-7 or the nucleotide of SEQ ID NO: 13 is a domain within the claimed polynucleotide comprising SEQ ID NOs: 1-7. Furthermore, claim 10 uses parentheses to comments on or qualify part of the sentences. It is unclear whether the limitations in parentheses are meant to be limitations in the claims or whether they are only suggestions/examples. As such, the metes and bounds of the claims cannot be determined. Claims 2, 5, 7-9, and 18 are rejected insofar as they depend on claim 1 35 U.S.C. 112 (d) 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. Claim 5 is 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. This is a new rejection necessitated by amendment of the claims in the response filed 4/30/2026. Claim 5 depends from claim 1. Claim 1 newly requires that the “SEQ ID NOs: 1-5 are flanked upstream by SEO ID NO: 6 and flanked downstream by SEO ID NO: 7”. Claim 5 broadens the scope of the claimed SEQ ID NOs: 1-5 are flanked upstream by SEO ID NO: 6 and flanked downstream by SEO ID NO: 7, permitting that it may be flanked by at least two of SEQ ID NOs: 1-7. Applicant may cancel the claim, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements. Conclusion Claims 1-2, 5, 7-10, and 18 are rejected. 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 KODYE LEE ABBOTT whose telephone number is (703)756-1111. The examiner can normally be reached M-F 8-5. 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, Maria G. Leavitt can be reached on (571) 272-1085. 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 /KODYE LEE ABBOTT/ Examiner, Art Unit 1634 /MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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Prosecution Timeline

Nov 20, 2024
Application Filed
Dec 29, 2025
Non-Final Rejection mailed — §112
Apr 30, 2026
Response Filed
May 27, 2026
Final Rejection mailed — §112 (current)

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