Prosecution Insights
Last updated: July 17, 2026
Application No. 17/761,641

COMPOSITIONS AND METHODS FOR DELIVERING CARGO TO A TARGET CELL

Final Rejection §102§103§112
Filed
Mar 18, 2022
Priority
Sep 20, 2019 — provisional 62/903,127 +2 more
Examiner
ABBOTT, KODYE LEE
Art Unit
1634
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Massachusetts Institute of Technology
OA Round
2 (Final)
56%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
14 granted / 25 resolved
-4.0% vs TC avg
Strong +65% interview lift
Without
With
+64.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
28 currently pending
Career history
57
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
66.7%
+26.7% vs TC avg
§102
3.0%
-37.0% vs TC avg
§112
25.8%
-14.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 25 resolved cases

Office Action

§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 . 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 01/302026. 1, 7, 9, 11, 13, 16-17, 23, 30, 32, 34-36, 39, 41, 45, 47-50, 52, 58, 60, 62-64, 67, 70, 73, 83, 85, 87, 90, 94, 96, 101, and 103-104 are currently pending. Claims 1, 7, 9, 11, 13, 16, 23, 30, 32, 34, 39, and 41 have been amended and claim 2-6, 8, 10, 12, 14-15, 18-22, 25-29, 31, 33, 37-38, and 40 have been cancelled by Applicant’s amendment filed on 01/30/2026. Election/Restrictions Applicant’s election of Group I, directed engineered delivery system which include claims 1, 7, 9-11, 13, 16-17, 23, 30, 32, 34-36, 39, 4l and election of species for Group I, PEG10 for the gag homology protein, a Type II CRISPR-Cas system, in the reply filed on 07/11/2025 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 Claims 45, 47-50, 52, 58, 60, 62-64, 67, 70, 73, 83, 85, 87, 90, 94, 96, 101, and 103-104 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.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-V was previously made FINAL. Therefore, claims 1, 7, 9, 11, 13, 16-17, 23, 30, 32, 34-36, 39, and 41 are subject to examination to which the following grounds of rejection are applicable. Information Disclosure Statement The information disclosure statements (IDS) submitted on 10/09/2025, 10/21/2025, 01/02/2026, and 03/23/2026 were filed before the mailing date of the non-final office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Withdrawn Objections/Rejections in response to Applicants’ arguments or amendmentsClaim Objections The objection of claims 1, 7, 9, 11, 13, 16, 23, 30 and 32 is withdrawn in view of the amendments in the response filed on 01/30/2026. Claim Rejections - 35 USC § 102 The rejection of claims 1, 11, 13, 16-17, 34-36, 39 under 35 U.S.C. 102(a)(1) as being anticipated by Ohlmann et al. as evidenced by Mark-Danieli et al. is withdrawn in view of the applicants’ amendments and arguments in the response filed on 01/30/2026. The prior rejection relied upon Ohlman’s teachings of retroviral gag-based virus like particles. Amended claim 1 now recites that the gag-homology protein be selected from a closed group of proteins not explicitly taught by Ohlmann: Paternally Expressed Gene 10 (PEG10), Paraneoplastic Ma antigen family member 3 (PNMA3), Paraneoplastic Ma antigen family member 4 (PNMA4), Paraneoplastic Ma antigen family member 5 (PNMA5), or Paraneoplastic Ma antigen family member 6 (PNMA6). Applicant’s arguments with regard to a withdrawn objection/rejection are moot. Maintained and modified rejections in response to Applicants’ arguments or amendments Claim Rejections - 35 USC § 112(b) Claims 9, 11, 13, 16 and 32 remain 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 9 has been amended to recite “wherein the PEGl0 protein comprises both open reading frame 1 (ORF1) and open reading frame 2 (ORF2)”. The practitioner in the art would readily understand that an Open Reading Frame (ORF) is a continuous stretch of DNA or RNA that begins with a start codon and ends at a stop codon, potentially encoding a protein. Thus, it is unclear the PEGl0 protein comprises ORF1 and ORF2. As such the metes and bounds of the claim are indefinite Claim 11 is indefinite in the recitation of the term “optionally”. This claim is indefinite because it is unclear if the “optionally” recited item is intended to be recited in the alternative or as an addition to the non-optional item. For the purposes of examination, the claim is interpreted as requiring only one polynucleotides encoding a retroviral envelope protein wherein the envelope protein is from a Gammaretrovirus or a Deltaretrovirus. Claims 13 and 32 are indefinite in their recitation of the term “optionally”. Thes claims are indefinite because it is unclear if the “optionally” recited item is intended to be recited in the alternative or as an addition to the non-optional item. For the purposes of examination, the claims are interpreted as requiring only the cargo-binding domain is a hairpin loop- binding element (for claim 13) and wherein the modification comprises incorporation of a hairpin loop that binds to a hairpin-binding element on the envelope protein (for claim 32). Claim 16 is rejected because of the recitation of “reduced immune response compared to a delivery system comprising exogenous retroviral proteins”. The use of the limitation of “exogenous retroviral proteins” should be relative to “endogenous retroviral proteins” which is not disclosed in the claim and is not defined in the specification. Thus, a skilled artisan would not be able to determine what “exogenous retroviral proteins” are relative to. Response to Applicants’ Arguments as they apply to rejection of claims 9, 11, 13, 16 and 32 under 35 USC § 112, second paragraph At page 14 of the remarks, Applicants essentially argue that “a reduced immune response compared to a delivery system comprising exogenous retroviral proteins." This provides a clear comparative standard. One of ordinary skill can measure immune response using standard assays (antibody titers by ELISA, T cell activation assays, cytokine profiling, neutralizing antibody assays) and directly compare the claimed system to a control system using exogenous retroviral proteins ( e.g., ML V Gag, HIV Gag, VSV-G).” Applicants’ arguments have been respectfully considered but have not been found persuasive. The claims as written do not require exogenous retroviral proteins. Hence the argument is not persuasive as they argue limitations that are not present in the claims. Claim Rejections - 35 USC § 103 Claims 7 and 9 remains rejected and claims 1, 11, 16-17, 34-36, 39, and 41 are newly rejected under 35 U.S.C. 103 as being unpatentable over Ohlmann et al. (WO2017068077A1, IDS filled 11/07/2022; hereafter “Ohlmann”) in view of Abed et al. (Abed M, PLoS One., 2019, IDS filed 10/27/2023; hereafter “Abed”) as evidenced by Clark et al. (Clark MB et al., J Biol Chem. 2007) and as evidenced by Mark Danieli et al. (Mark-Danieli M., J Virol. 2005). This rejection has been modified in response to the claim amendments filed 01/30/2026. Regarding Claims 1 and 7, Ohlmann teaches use of virus-derived particles (which are also termed "Virus Like Particles" or "VLPs" herein (Pg. 14, Lines 10-12)) as a delivery system (Pg. 14, Line 1), which can be formed by one or more retrovirus-derived structural protein(s) and optionally one or more virus-derived envelope protein(s) (Pg. 21, Line 1). The virus-derived structural protein may be a retroviral gag protein or a peptide fragment thereof. Gag and Gag/pol precursors are expressed from full length genomic RNA as polyproteins, which require proteolytic cleavage, mediated by the retroviral protease (PR), to acquire a functional conformation (Pg. 21, Lines 4-10). This reads on the requirement of a polynucleotide requirement encoding retroviral elements within the delivery system. Ohlmann teaches the delivery system may contain cargo (Pg. 17, Lines 1-6). Ohlmann does not teach the use of PEG10 as the gag-homology protein. Abed cures the deficiencies of Ohlman as Abed demonstrates characterization of PEG10 that would lead a person of ordinary skill in the art to consider its use as a gag-homology protein. Abed teaches a method of successful generation of PEG10 VLPs (Pg. 5, Section: Lentivirus and PEG10 VLP generation; Pg. 10, Section: The PEG10 Gag domain forms virus-like particles). Abed teaches that PEG10 can bind to RNA and can promote vesicle budding (Pg. 15, Section: PEG10 binds to cellular RNAs). Further, Abed teaches that PEG10 is an endogenously domesticated transposable element, meaning that it has been repurposed during evolution for the benefit of the host (Pg. 1-2, Introduction). It would have been obvious to a person of ordinary skill in the art at the time of the application to modify the VLP taught by Ohlmann to include use of PEG10, as taught by Abed, as a gag-homology protein as either the retroviral Gag structural protein or by otherwise using PEG10 as the gag-homology particle-forming component as Abed teaches PEG10 was a known Gag-like protein capable of forming VLPs, binding RNA, and promoting vesicle budding. One would be motivated perform this modification as Ohlmann seeks to provide VLP- based delivery system using Gag-derived structural proteins for particle formation and cargo delivery, and Abed teaches PEG10 possesses analogous Gag-like vesicle forming and RNA-binding properties. Further, it would be expected by one of ordinary skill in the art that using an endogenously expressed protein such as PEG10 would limit undesired immune response relative to exogenous retroviral structural proteins, which would be an advantageous property for a VLP used to deliver therapeutic cargo. There would be a reasonable expectation of success as Abed specifically teaches that PEG10 retains the relevant functional capacity for VLP formation, RNA binding and vesicle budding and it would have been a matter of combining known prior art elements according to known methods to yield predictable results from the inclusion of PEG10 as taught by Abed. Regarding Claim 9, The recitation of “wherein the gag-homology protein is PEGl0, and wherein the PEG10 protein comprises both open reading frame 1 (ORF1) and open reading frame 2 (ORF2).” would be an inherent to the PEG10 of the system as evidenced by Clark et al. who describes the PEG10 gene as containing two open reading frames, ORF1 and 2 (Abstract). Regarding Claim 11, Ohlmann and Abed together render obvious the system of claim 1 as discussed in the 103 rejection above. Moreover, Ohlmann teaches the envelope protein can be from the gamma retrovirus Moloney virus (Pg. 21, Lines 23-29). Regarding Claim 16, The recitation of “wherein the delivery system elicits a reduced immune response compared to a delivery system comprising exogenous retroviral proteins.” would be an inherent effect of the system of claim 1 as taught by Ohlmann and Abed. Therefore, the characteristics, as recited in claim 16, is taught by Ohlmann and Abed, absent evidence to the contrary. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02. Regarding Claim 17, Ohlmann and Abed together render obvious the system of claim 1 as discussed in the 103 rejection above. Moreover, Ohlmann teaches multiple cargos including nucleic acid or proteins (Pg. 17, Lines 1-6). Regarding Claim 23, Ohlmann teaches genetic modulating agents (as cargo) of the VLPs (Pg. 32, Lines 4-17) and specifically discussed targeting nucleic acids for the purpose of altering their sequences (Pg. 32, Lines 25-32). Regarding Claims 34, 39, and 41, Ohlmann and Abed together render obvious the system of claim 1 as discussed in the 103 rejection above. Moreover, Ohlmann teaches with respect to their delivery system, “Exploiting the technology of virus-derived particles described herein offers a large panel of viral envelopes that can be selected to pseudo type the said virus-derived particles, thus conferring particular properties to the preparation (tropism, complement resistance, robustness).” (Pg. 16, Lines 9-13; Pg. 77, Figure 1). This reads on a targeting moiety and specific binding to the cell as recited in claim 34. Ohlmann teaches the delivery system may have a viral envelope comprising VSV-G protein (Pg. 21, Lines 21-29), which reads claim 39 of the instant application. Moreover, Ohlmann teaches the target cell of the delivery system may be a mammalian cell (Pg. 40, Lines 23-29), which reads claim 41 of the instant application. Regarding Claim 35, Ohlmann and Abed together render obvious the system of claim 1 as discussed in the 103 rejection above. Moreover, Ohlmann teaches functional components for incorporating guide RNAs and CRISPR-Cas cargo into virus like particles (Pg. 17, Lines 7-24;Pg. 32, Lines 4-17) and also teaches “Further, Gag, which is structurally conserved among the retroviruses, is composed of at least three protein units: matrix protein (MA), capsid protein (CA) and nucleocapsid protein (NC), whereas Pol consists of the retroviral protease, (PR), the retro transcriptase (RT) and the integrase (IN).” (Pg. 21, Lines 4-10). The NC domain contains zinc finger motifs that recognizes and packages RNA as evidenced by Mark-Danieli et al. (Abstract; Pg. 7756, final paragraph, transitioning into Pg. 7757). Regarding Claim 36, Ohlmann and Abed together render obvious the system of claim 1 as discussed in the 103 rejection above. Moreover, Ohlmann teaches use of virus-derived particles (which are also termed "Virus Like Particles" or "VLPs" herein (Pg. 14, Lines 10-12)) as a delivery system (Pg. 14, Line 1). Response to Applicants’ Arguments as they apply to the modified rejection of claims 1, 11, 16-17, 34-36, 39, and 41, which are newly rejected under 35 U.S.C. 103, and Claims 7 and 9, which remains rejected under 35 U.S.C. 103 At pages 15-17 of the remarks filed on 1/30/2026, Applicants’ essentially argue that Ohlmann does not disclose the amended claim 1 and therefore cannot anticipate claim 1 or the claims which depend from claim 1. Applicant’s arguments with regard to a withdrawn objection/rejection are moot. At Pg. 15 applicant provides the limitations of the amended claim 1 as follows, “Amended Claim 1 now requires "a gag-homology protein selected from Paternally Expressed Gene 10 (PEG10) (elected species), Paraneoplastic Ma antigen family member 3 (PNMA3), Paraneoplastic Ma antigen family member 4 (PNMA4), Paraneoplastic Ma antigen family member 5 (PNMA5), or Paraneoplastic Ma antigen family member 6 (PNMA6)." Ohlmann et al. in view of Abed et al. as evidenced by Clark et al. (Clark MB et al., J Biol Chem. 2007) render obvious claims 1, 7, 9, 11, 16-17, 34-36, 39, and 41. Applicants’ arguments at pages 17-20 pertaining to this new rejection are essentially that Ohlmann and Abed together do not overcome claims 1, 7, 9, 11, 16-17, 34-36, 39, and 41 as they are non-analogous, there is no motivation to combine, there is improper hindsight, and there would be no reasonable expectation of success. These arguments have been considered, but have not been found persuasive. At Pg. 17, Applicant asserts the following: “Applicant respectfully traverses the rejection. First, the law requires that references be analogous art-within the field of the inventor's endeavor or reasonably pertinent to the problem being solved. In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011).” and “One of ordinary skill in therapeutic delivery would not consult developmental biology and cancer biology literature when designing cargo delivery systems. The Examiner provides no reasoning explaining why a delivery researcher would consult Abed's placental biology study. These are non-analogous fields.” In response to applicant's argument that the teachings of Ohlmann and Abed are non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the amended claims are directed to delivery vesicles formed from specific gag-homology protein, including PEG10. Abed directly teaches PEG10’s gag-like VLP forming and RNA-associating properties. A person seeking Gag-like structural proteins to optimize a VLP or vesicle based cargo delivery would reasonably consider a reference teachings that PEG10 forms VLP-like particles, can bind RNA, and will bud from cells. At Pg. 17-18 applicant asserts the following: “Second, there is no motivation to combine apparent from the references themselves. The Examiner's rationale that "using an endogenously expressed protein such as PEGI0 would limit undesired immune response" (Page 12) is the problem Applicant's invention solves, not a teaching of the prior art. This improperly uses hindsight and Applicant's disclosure to supply motivation. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Neither reference teaches that exogenous viral vectors have immunogenicity problems requiring solution, that endogenous proteins could serve as alternatives, or that PEGl0 could be engineered for cargo delivery. Ohlmann is silent on immune response concerns.” In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Ohlmann teaches a Gag-derived VLP system for delivery of cargo to cells. Abed teaches PEG10 as a gag-like protein that forms VLPs and can associate with RNA. One of ordinary skill would have had reason to use PEG10 in Ohlmann’s system because PEG10 was known to possess relevant characteristics that would be desired properties in Ohlmann’s system, namely the previously discussed vesicle formation, RNA association, and budding properties. The modification represents a predictable use of a known Gag-like protein with a well described function. At Pg. 18-19 applicant asserts there would be no reasonable expectation of success combining these teachings. Applicant provides the following: “Third, there would have been no reasonable expectation of success. The art understood endogenous retroviral elements as evolutionarily inactivated remnants. The specification acknowledges at paragraph [0162] that HERVs have "accumulated mutations, deletions and/or truncations" and form "defective, non-self-propagating viral particles." Multiple authoritative references establish this understanding:…” Applicant the points to generalized statements pertaining to endogenous retroviral or retroelement derived sequences being defective remnants in the teachings of Bannert and Kurth, Jem and Coffin and Wilschutte et al. and quote their teachings pertaining to defective HERVS. These arguments are not persuasive as Abed teaching’s detail that PEG10 is not a nonfunctional remnant, but retains the previously discussed vesicle formation, RNA association, and budding functionality. Further, the claims do not require PEG10 to function as a replication-competent retrovirus. The claims require a gag-homology protein that forms a delivery vesicle and capture moieties for packaging cargo. Abed’s teachings would have provided reasonable expectation that PEG10 could perform the vesicle-forming and RNA-associating role in Ohlmann’s delivery system. Applicant argues that “Critically, none of the cited references demonstrates that endogenous retroviral proteins can form functional delivery vesicles capable of packaging heterologous cargo. Abed shows that PEG 10 forms VLPs in the context of studying its natural cellular function in placentation and cancer. Abed does not demonstrate, teach, or suggest that: 1. PEG l0 VLPs can package heterologous cargo selected and designed by a researcher (as opposed to whatever endogenous nucleic acids PEG10 may naturally associate with) 2. PEG 10 can be engineered to incorporate capture moieties for recruiting specific therapeutic cargo 3. PEG 10 VLPs can deliver large, complex cargos such as CRISPR-Cas systems comprising Cas proteins, guide RNAs, and associated components 4. PEG 10-based delivery achieves functional therapeutic outcomes in target cells” These arguments are not found persuasive. The rejections above do not rely on an individual references to overcome the instant applications claims, the rejections is based on the combined teachings which render the claimed systems obvious as discussed in the 103 rejections above. New objection/ rejections in response to Applicants’ arguments or amendments Claim objection Claim 1 is objected to because of the following informalities: claim 1 is a Markush-type claim which recites “selected from.” A proper Markush-type claim recites alternatives in a format such as “selected from the group consisting of A, B and C.” See Ex parte Markush, 1925 C.D. 126 (Comm’r Pat. 1925). Appropriate correction is requested. Claim 13 is objected to because of the following informalities: Claim 13 recites “wherein the envelope protein comprises a cargo-binding domain, optionally wherein the cargo-binding domain is a hairpin loop- binding element and is optionally an MS2 aptamer.” It appears the applicant intended to recited “is optionally an MS2 aptamer-binding domain.” Appropriate correction is requested. Please see also the 112b rejection of claim 13 above with respect to claim interpretation. Claim Rejections - 35 USC § 103 Claims 13, 30, and 32 are newly rejected under 35 U.S.C. 103 as being unpatentable over Ohlmann et al. (WO2017068077A1, IDS filled 11/07/2022; hereafter “Ohlmann”) as evidenced by Mark Danieli et al. (Mark-Danieli M., J Virol. 2005;), and in view of Abed et al. (Abed M, PLoS One., 2019, IDS filed 10/27/2023;hereafter “Abed”) as applied to claims 1, 11, and 23 above, and in further view of Hung et al. (Hung ME et al., J Extracell Vesicles., 2016; hereafter “Hung”) and Nowak et al. (Nowak CM et al., Nucleic Acids Res. 2016, IDS filled 11/07/2022; hereafter “Nowak”). This new rejection is in response to claim amendments filed 01/30/2026. Claims 30-32 were previously dependent upon cancelled claims. As the dependency could not be determined, it is unclear which elements the applicant intended to claim as part of the invention. As such the claims will were not previously examined on the merits. Regarding Claims 13, 30, and 32, Ohlmann and Abed together render obvious the delivery system of claims 1, 11, and 23 as discussed in the 103 rejection above, the contents of which is incorporated herein in its’ entirety. Ohlmann and Abed together do not teach a Cas protein or guide molecule modified to bind a binding domain of an envelope protein or that the guide molecule contains a hairpin loop that binds a hairpin loop-binding element on an envelope protein. Hung teaches RNA cargo loading into vesicles is enhanced by fusing an RNA-binding protein, such as MS2 coat protein, to vesicle-associated proteins (including VSVG) and engineering the cognate MS2 stem-loop into the cargo RNA (Abstract; Figure 1.). (For instant claim 13) Nowak teaches sgRNAs modification can include MS2 loops/hairpin aptamers that bind MCP with altering sgRNA function. Specifically, Nowak teaches the following at Pg. 9560, 1st full paragraph: 1. incorporation of separate RNA secondary structures into sgRNA scaffold without comprising Casp9. 2. MS2 bacteriophage coat proteins (MCP) can dimerize and selectively bind a specific RNA hairpin forming aptamer (supporting hairpin loop/hairpin-binding elements). 3. MS2 loops engineered onto sgRNA can localize to specific area and recruit corresponding MCP-effector fusions (supporting guide molecule modified to bind mcp/ms2 binding domains). 4. MS2 loops selectively bind MCP incorporated into the sgRNA 3’ end (Figure 4.) (For instant claims 30 and 32) It would have been obvious to a person having ordinary skill in the art at the time of the instant application to modify the teachings Ohlmann and Abed comprised of a CRISPR-CAS9 VLP delivery system to further include the RNA-loading strategy taught by Hung and the engineered guide RNA hairpin strategy taught by Nowak. Ohlmann and Abed together teach delivery of CRISPR-Cas cargo by VLPS, including gRNAs, while hung teaches RNA cargo loading into vesicles can be improved by fusing MS2 coat protein to a vesicle-associated protein such as VSV-G and engineering the cognate MS2 stem-loop into the cargo RNA. Nowak teaches sgRNA can be modified to include MS2/aptamer loops that bind MS2 coat protein while retaining CRISPR functionality. One would have been motivated to combine these teachings to improve or control loading of guide RNA cargo into Ohlmann’s and Abed’s CRISPR delivery particles by using a known RNA-binding pair, MS2/MCP, for RNA recruitment in a vesicle loading context. Specifically, the VSV-G/MS2 fusion taught by Hung would provide a binding domain on the envelope protein, while the MS2-loop-modified sgRNA taught by Nowak would provide the corresponding hairpin-containing molecule. This would predictably produce a system capable of recruiting guide RNA cargo to the vesicle-associated envelope for packaging into delivery particles. There would have been reasonable expectations of success in combining these teachings as one of ordinary skill in the art would recognize to combine known elements in the art to give predictable results. The combination merely applies a known modular RNA-binding loading pair to the CRISP-VLP delivery platform which would expectedly improve guide RNA recruitment and packaging. Conclusion 1, 7, 9, 11, 13, 16-17, 23, 30, 32, 34-36, 39, and 41 are rejected. No claims are 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 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
Read full office action

Prosecution Timeline

Show 1 earlier event
Mar 18, 2022
Response after Non-Final Action
Oct 26, 2022
Response after Non-Final Action
Oct 04, 2023
Response after Non-Final Action
Apr 22, 2025
Examiner Interview Summary
Apr 22, 2025
Examiner Interview (Telephonic)
Oct 01, 2025
Non-Final Rejection mailed — §102, §103, §112
Jan 30, 2026
Response Filed
May 29, 2026
Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
56%
Grant Probability
99%
With Interview (+64.7%)
3y 3m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 25 resolved cases by this examiner. Grant probability derived from career allowance rate.

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