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 Amendment filed on 04/06/2026; and IDS filed on 04/06/2026.
Claims 1-3, 24 have been amended.
Claims 27-34 have been added.
Claims 4-6, 8-11, 16 have been canceled.
Claims 1-3, 7, 15, 17-18, 22-34 are pending in the instant application.
Claims 3, 7, 15, 17-18, 22-26 have been previously withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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, 27-34 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).All the ingredients would be associated with the ARRDC1 protein, because all the ingredients are in the same composition.
The patent does not teach using a viral envelope protein, such as VSV-G.
WONG teaches the prior art had known of using targeting polypeptides, such as 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 targeting agents, such as viral envelope proteins, 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 target neural cells and 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, 27-34 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). All the ingredients would be associated with the ARRDC1 protein, because all the ingredients are in the same composition.
The patents do not teach using a viral envelope protein, such as VSV-G.
WONG teaches the prior art had known of using targeting polypeptides, such as 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 targeting agents, such as viral envelope proteins, 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 target neural cells and 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, 27-34 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]). All the ingredients would be associated with the ARRDC1 protein, because all the ingredients are in the same composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 27-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/490,611 (reference application) in view of WONG et al (US 2017/0073382) and WANG et al (US 2008/0318882).
The co-application recites an arrestin domain-containing protein 1 (ARRDC1)-mediated microvesicle (ARMM), comprising: (i) a lipid bilayer; (ii) an ARRDC1 protein or variant thereof; (iii) a TSG101 protein or variant thereof; and (iv) a Cas9 protein, wherein the Cas9 protein is linked to the TSG101 protein or variant thereof (see claim 97), wherein the TSG101 protein or variant thereof is linked to the Cas9 protein via a cleavable linker (see claim 99).
The co-application does not teach using a viral envelope protein, such as VSV-G.
WONG teaches the prior art had known of using targeting polypeptides, such as 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 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 targeting agents, such as viral envelope proteins, 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 target neural cells and 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 § 112, 1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-2, 27-34 is 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.
Regarding claims 1 and 27, the “variant thereof” does not meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus of variants encompassed by the claim, since there is no description of the structural relationship of these variants provided in the specification and Applicant has not provided a description as to how the base molecule may be changed while remaining a variant.
The dependent claims fall therewith.
Claim 30 recite the newly amended limitation of “cytotoxic agent”; however, the specification as-filed does not provide a written description or set forth the metes and bounds of this phrase. The instant claims now recite limitations which were not clearly disclosed in the specification as-filed and now change the scope of the instant disclosure as-filed. Such limitations recited in the present claims, introduce new concepts and thus violate the written description requirement of the first paragraph of 35 U.S.C. §112.
Applicant is required to cancel the new matter in the response to this Office action. Alternatively, Applicant is invited to identify sufficient written support in the original specification for the "limitations" indicated above.
Claim Rejections - 35 USC § 112, 2nd paragraph
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.
Claim 34 is 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.
The term “small” in claim 34 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instance, when is the molecule NOT small?
For compact prosecution, any molecule will read on small molecule.
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, 30-31, 34 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 would read on small molecule (Applicant’s claim 34) and would be associated with ARRDC protein, because all the ingredients are in the same composition.
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, 27-34 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 (see abstract) protein or nucleic acid (see abstract; and [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, which are therapeutic agents (see [0024], and would be associated with the ARRDC1 protein, because all the ingredients are in the same composition. Additional disclosures include: Cas9 cargo protein is linked to the ARRDC1 protein (see [0009]), wherein the linker could be a covalent bond or another linker, such as a cleavable linker (see [0009]); WW domains (see [0011]; and [0015]-[0023]).
LU does not teach using a viral envelope protein, such as VSV-G.
WONG teaches the prior art had known of using neural cell targeting polypeptide (see [0125]), such as 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 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 a targeting agent, such as a 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 target neural cells and increase nucleic acid/protein entry into cells for therapeutic treatment, and reasonably would have expected success because the references dealt in the same field of endeavor, such as delivery of bioactive agents into cells.
Response to Arguments
Applicant argues that claim 1 is amended to recite that the ARMM comprises an agent that is associated with the ARRDC 1 protein or variant thereof. Maltzahn does not teach a microvesicle comprising an agent that is associated with the ARRDC1 protein or variant thereof. Accordingly, amended claims 1 and 2 are novel.
The Examiner finds this argument unpersuasive, because as discussed in the rejection, all the ingredients would be associated with the ARRDC1 protein, because all the ingredients are in the same composition.
Applicant argues that Wong is described by the Examiner as disclosing the use of viral envelope proteins to associate with or bind neural cells. However, Wong discloses the use of exosomes (not microvesicles) and explains that it is important that the exosomes be derived from microglial cells to be useful in reprogramming "astroglial cells to neuronal cells." Because Wong discloses expressing RVG in only one specific cell type, and because Wong discloses that this cell type is important because this cell type migrates to the cells of interest, one skilled in the art would not have been motivated to use the same RVG protein in other cells, such as the ARMMs of Lu. Indeed, Lu does not describe the necessity of using any particular cell type to create ARMMs, much less the need to use microglial cells. Accordingly, there is no reason provided why one skilled in the art would have been motivated to combine Wong with Lu. Furthermore, Wong discloses the use of a viral envelope protein in microglial exosomes, but as the present Application makes clear, exosomes are distinct from the present ARMMs, both in their molecular makeup and how they are produced.
The Examiner finds this argument unpersuasive, because Applicant is requiring WONG to be a 102 reference, wherein WONG is a secondary reference to show the prior art had known of targeting agents, such as viral envelope proteins. As discussed in the rejection, the primary reference LU teaches using ARRDC1-mediated microvesicles as a carrier/vesicle of therapeutics, such as protein or nucleic acid, to cells, wherein the secondary reference WONG teaches using neural cell targeting polypeptide (see [0125]), such as viral envelope proteins to associate with or bind to neural cells (see [0125]) for delivering polypeptide/proteins of interest to astroglial cell (see abstract). Thus, it would have been obvious to add a targeting agent, such as viral envelope proteins.
Applicant argues that there would have been no motivation to combine Wang with Lu to arrive at the present invention. The Examiner asserts that Wang discloses the use of VSV-G "to increase nucleic acid entry into mammalian cells." Office Action at page 10. However, Wang is a reference that discloses the importance of delivering viral vectors directly to a local site for targeting neuronal cells. For example, Wang states "methods for delivering a nucleic acid into a peripheral neuron by identifying a target neuron in a dorsal root ganglion and intrathecally delivering a vector comprising the nucleic acid to the dorsal root neuron." Wang, Abstract. Wang explains that the reason for delivering intrathecally the vectors with nucleic acids of interest is to target neuronal cells, specifically that once a target neuronal cell is identified, a vector comprising the nucleic acid should be administered at a site that "is sufficiently proximal to the dorsal root ganglion to deliver the nucleic acid into the cell body of the target neuronal cell." Id., [0007]. Wang also notes that "[t]he inventors have surprisingly discovered that the administration of nucleic acid vectors into cerebrospinal fluid surrounding the spinal cord is an effective way of delivering exogenous nucleic acids into the soma of neurons in dorsal root ganglia." Id [0023]. Because Wang discloses the necessity of administering the viral vectors directly to the site for neuronal cell targeting, one skilled in the art would not have used the same RVG or VSV-G protein in the ARMMs of Lu for the same reason as described above for Wong. The Examiner does not explain why a person of ordinary skill in the art would have been motivated to combine the teaching of Wang with the use of the ARMMs of Lu. Moreover, the Examiner has not established that there would have been a reasonable
expectation of success of combining Lu with either Wong or Wang, or both, to arrive at the present invention.
The Examiner finds this argument unpersuasive, because Applicant is requiring WANG to be a 102 reference, wherein WANG is a secondary reference to show the prior art had known of targeting agents, such as viral envelope proteins. As discussed in the rejection, the primary reference LU teaches using ARRDC1-mediated microvesicles as a carrier/vesicle of therapeutics, such as protein or nucleic acid, to cells, wherein the secondary reference WONG teaches using neural cell targeting polypeptide (see [0125]), such as viral envelope proteins to associate with or bind to neural cells (see [0125]) for delivering polypeptide/proteins of interest to astroglial cell (see abstract), wherein WANG teaches VSVG are viral envelope proteins. Thus, it would have been obvious to add a targeting agent, such as viral envelope proteins, such as VSVG. 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.
Applicant argues that because claims 1 and 2 are not rendered obvious in view of the reference patents and reference application, even in combination with Wong and Wang, as explained above, the reference patents and reference application similarly cannot render claims 1 and 2 obvious for the purposes of obviousness-type double patenting.
The Examiner finds this argument unpersuasive, because as discussed above, claims 1 and 2 are rendered obvious in view of the reference patents and reference application, even in combination with Wong and Wang, as explained above.
Conclusion
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.
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.
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, 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
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