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 .
Receipt is acknowledged of Applicant’s Restriction Requirement Response filed on 11/17/2025; and IDS filed on 11/17/2025, 12/30/2024, an d06/12/2023.
Claim 3 is drawn to a non-elected specie.
Claims 1-11, 15-18, 22-26 are pending in the instant application.
Claims 3-11, 15-18, 22-26 are withdrawn from consideration.
Election/Restrictions
Applicant’s election Group I (claims 1-3) and specie election of “VSV-G” in the reply filed on 11/17/2025 is 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)).
Note, claim 3 is drawn to non-elected species.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 10,260,055 in view of WONG et al (US 2017/0073382) and WANG et al (US 2008/0318882).
The patents recite an arrestin domain-containing protein 1 (ARRDC1)-mediated microvesicle (ARMM), comprising: (i) a lipid bilayer and an ARRDC1 protein, and (ii) a cargo protein, wherein the cargo protein is linked to the ARRDC1 protein via one or more WW domains, and wherein the cargo protein is a transcription factor, a tumor suppressor, a developmental regulator, a growth factor, a metastasis suppressor, a pro-apoptotic protein, a nuclease, a recombinase, or a reprogramming factor (see US 10,260,055 at claim 1).
The patent does not teach using a viral envelope protein, such as VSV-G.
WONG teaches the prior art had known of using viral envelope proteins to associate with or bind to neural cells (see [0125]) for delivering polypeptide/proteins of interest to astroglial cell (see abstract).
WANG teaches the prior art had known of using viral envelope proteins viral envelope glycoprotein, such as vesicular stomatitis virus G protein (“VSVG”; see [0035]), to increase nucleic acid entry into mammalian cells (see [0035]) for delivery of nucleic acids to neuron cells (see abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate viral envelope protein, such as VSV-G. The person of ordinary skill in the art would have been motivated to make those modifications, because the viral envelope protein would increase nucleic acid/protein entry into cells, and reasonably would have expected success because the references dealt in the same field of endeavor, such as delivery of bioactive agents into cells.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,503,497 in view of WONG et al (US 2017/0073382) and WANG et al (US 2008/0318882).
The patent recites an arrestin domain-containing protein 1 (ARRDC1)-mediated microvesicle (ARMM) comprising: a lipid bilayer and a minimal ARRDC1 protein, wherein the minimal ARRDC1 protein comprises the minimal ARRDC1 protein of claim 1 (see claim 9), wherein the microvesicle further comprises an agent (see claim 10), wherein the agent is selected from the group consisting of a nucleic acid, a protein, and a small molecule (see claim 15).
The patents do not teach using a viral envelope protein, such as VSV-G.
WONG teaches the prior art had known of using viral envelope proteins to associate with or bind to neural cells (see [0125]) for delivering polypeptide/proteins of interest to astroglial cell (see abstract).
WANG teaches the prior art had known of using viral envelope proteins viral envelope glycoprotein, such as vesicular stomatitis virus G protein (“VSVG”; see [0035]), to increase nucleic acid entry into mammalian cells (see [0035]) for delivery of nucleic acids to neuron cells (see abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate viral envelope protein, such as VSV-G. The person of ordinary skill in the art would have been motivated to make those modifications, because the viral envelope protein would increase nucleic acid/protein entry into cells, and reasonably would have expected success because the references dealt in the same field of endeavor, such as delivery of bioactive agents into cells.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/845,704 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-application recites An arrestin domain-containing protein 1 (ARRDC1)-mediated microvesicle (ARMM), comprising: (i) a lipid bilayer and an ARRDC1 protein or a variant thereof, (ii) a Nipah virus (NiV) glycoprotein variant fused to an antibody or antigen-binding fragment, wherein the NiV glycoprotein variant does not recognize and/or bind to an ephrin receptor, and (iii) a NiV fusion protein (see claim 1), wherein Nipah virus (NiV) glycoprotein reads on virus envelope protein (see specification at [0005]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/343,685; 18/490,611 (reference application) in view of WONG et al (US 2017/0073382) and WANG et al (US 2008/0318882).
The co-applications recite an arrestin domain-containing protein 1 (ARRDC1)-mediated microvesicle (ARMM) comprising: a lipid bilayer; an ARRDC1 protein or variant thereof, wherein the ARRDC1 protein variant comprises a PSAP motif, a PPXY motif, or both, and wherein the ARRDC1 protein variant comprises an amino acid sequence that is at least about 80% identical to the amino acid sequence of any of any of SEQ ID NOs: 15-17; an RNA binding protein fused to at least one WW domain or variant thereof; and a binding RNA, wherein the binding RNA is associated with the RNA binding protein (see 18/343,685 at claim 2).
The co-applications do not teach using a viral envelope protein, such as VSV-G.
WONG teaches the prior art had known of using viral envelope proteins to associate with or bind to neural cells (see [0125]) for delivering polypeptide/proteins of interest to astroglial cell (see abstract).
WANG teaches the prior art had known of using viral envelope proteins viral envelope glycoprotein, such as vesicular stomatitis virus G protein (“VSVG”; see [0035]), to increase nucleic acid entry into mammalian cells (see [0035]) for delivery of nucleic acids to neuron cells (see abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate viral envelope protein, such as VSV-G. The person of ordinary skill in the art would have been motivated to make those modifications, because the viral envelope protein would increase nucleic acid/protein entry into cells, and reasonably would have expected success because the references dealt in the same field of endeavor, such as delivery of bioactive agents into cells.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(as)(1) as being anticipated by MALTZAHN et al (WO 2020/102485).
MALTZAHN teaches a microvesicle (see pg. 34, line 28) composition comprised of: a lipid bilayer (see claim 1) and a fusogen (see claim 1), such as viral envelope protein (see pg. 96, line 10), such as vesicular stomatitis virus G (see pg. 95, line 30; pg. 97, line 24; and pg. 347, Example 65; and pg. 373, Example 92); ARRDC1 (see pg. 373, Example 92); and nucleic acid (see claim 1), which reads on molecule (see Applicant’s abstract).
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.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over LU et al (US 2018/0119118) in view of WONG et al (US 2017/0073382) and WANG et al (US 2008/0318882).
LU teaches a method of delivering and/or proteins or protein variants (see abstract), such as nucleic acid (see [0024] into cells (see abstract) using a composition, such as an arrestin domain-containing protein 1 (ARRDC1)-mediated microvesicles (ARMMs) that comprise a lipid bilayer, an ARRDC1 protein (see [0008]); and a small molecule, such as proteins and nucleic acids (see [0024]).
LU does not teach using a viral envelope protein, such as VSV-G.
WONG teaches the prior art had known of using viral envelope proteins to associate with or bind to neural cells (see [0125]) for delivering polypeptide/proteins of interest to astroglial cell (see abstract).
WANG teaches the prior art had known of using viral envelope proteins viral envelope glycoprotein, such as vesicular stomatitis virus G protein (“VSVG”; see [0035]), to increase nucleic acid entry into mammalian cells (see [0035]) for delivery of nucleic acids to neuron cells (see abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate viral envelope protein, such as VSV-G. The person of ordinary skill in the art would have been motivated to make those modifications, because the viral envelope protein would increase nucleic acid/protein entry into cells, and reasonably would have expected success because the references dealt in the same field of endeavor, such as delivery of bioactive agents into cells.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618