DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendments of 01/20/2026 have been entered in full. Claims 1, 2, 5, 19-23, 25, 28,29, 48, 49, 53, 64, and 74 are pending.
All prior objection/rejections not specifically maintained in this Office action are hereby withdrawn in view of Applicant’s amendment and/or arguments filed 01/20/2026.
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.
Claim 5 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.
Claim 5 is unclear as it recites dependency from a canceled claim. For purposes of further consideration claim 5 will be interpreted as depending from claim 2.
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, 5, 19-23, 25, 28,29, 64, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190216857 (Pena; of record), US 20210030807 (Aricha), US 20220177881 Momen-Heravi, and US 20210371862 (Valles-Sanchez).
Pena teaches compositions of aqueous humor and/or vitreous humor derived extracellular vesicles and their use for the delivery of therapeutic agents. The extracellular vesicles are modified to contain one or more exogenous agents, such as nucleic acid molecules, proteins and polypeptides, small molecules, or hormones [0030][0044-0084], i.e. bioactive molecules as in all pending claims. The extracellular vesicles may be administered directly to the site where therapy is required [0089], i.e. by compartmental administration, as in all pending claims. The extracellular vesicles may be further modified to express or display a eukaryotic cell-specific targeting molecule or moiety on the outer surface of the vesicular body, as in claim 22. The targeting moiety may be a ligand for a receptor or an antibody or fragment thereof, and can be selected to target the extracellular vesicle to a particular tissue type such as, for example, the brain, [0085-0088], as in claims 23 and 25. The extracellular vesicle compositions may be applied to a polymeric implant to provide sustained delivery, as in claims 20 and 21 [0092]. Thus, while Pena generally teaches local administration and targeting of therapeutic extracellular vesicles to the brain, Pena does not specifically teach the intraparenchymal, intra-cisterna magna and intracerebroventricular administration recited in the amended claims.
Aricha teaches methods for using exosomes comprising bioactive molecules to treat neurodegenerative diseases [0039]. The exosomes may be implanted or injected into the central nervous system, or more specifically, intrathecally [0304][0449].
Momen-Heravi teaches local intracerebroventricular (ICV), intracisternal, and intrathecal injection of therapeutic exosomes or extracellular vesicles [0176]. For local administration exosomes or extracellular vesicles maybe injected directly into the desired target site, e.g., in a depot or sustained release formulation [0149]. The exosomes or extracellular vesicles may comprise a cell-specific, tissue-specific, or organ-specific targeting moiety, which may be an antibody or natural ligand for a receptor for brain targeting [0143-0145].
In view of Pena, Aricha, and Momen-Heravi, it is clear that injection or implantation of therapeutic exosomes to the brain or central nervous system in general, and in particular by intracerebroventricular intracisternal, and intraparenchymal routes of administration, were known in the art prior to the filing date of the instant application.
Valles-Sanchez teaches intrathecal and intraparenchymal administration of a gene delivery vehicle [0052][0076]. After injection, the target cells incorporate the expressed gene product into exosomes that spread to surrounding tissue, creating a bystander effect [0038][0168]. Valles-Sanchez provides additional expectation of success performing the recited methods by applying the methods suggested by Pena, Aricha, and Momen-Heravi, first because all of the recited routes are amenable to injection. Secondly, one of skill in the art would reasonably expect that administered exosomes would likewise deliver bioactive molecules not only to the immediate site of administration but also to surrounding tissue.
Therefore, the methods of claims 1, 2, 5, 19-23, 25, 28,29, 64, and 74 are prima facie obvious over the combined teaching of Pena, Aricha, Momen-Heravi, and Valles-Sanchez.
Claims 48,49, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Pena, Aricha, Momen-Heravi, and Valles-Sanchez as applied to claims 1, 2, and 22, above, and further in view of US 20190060483 (Dooley; of record), and US 20220323519 (Noyes; of record).
The teachings of Pena, Aricha, Momen-Heravi, and Valles-Sanchez are detailed above. These references teach or suggest the general methods of claims 1,2, and 22, but they do not specifically teach the scaffold limitations of claims 48,49, and 53, which are dependent from claim 22.
Dooley and Noyes are analogous to the present application, Pena, Aricha, Momen-Heravi, and Valles-Sanchez, as they each teach extracellular vesicles or exosomes comprising a biologically active molecule (Dooley [0029-0031; Noyes [0019]). Dooley teaches extracellular vesicles or exosomes comprising a biologically active molecule [0029-0031]. Dooley teaches that CD9, Lamp2B, PDGFR, lactadherin, CD63 and CD81, all recited in claim 49, are known scaffold proteins in exosomes [0008]. Dooley further teaches additional scaffold proteins recited in claim 49, including PTGFRN); basigin (BSG); immunoglobulin superfamily member 2 (IGSF2); immunoglobulin superfamily member 3 (IGSF3); immunoglobulin superfamily member 8 (IGSF8); integrin beta- 1 (ITGB1); integrin alpha-4 (ITGA4); 4F2 cell-surface antigen heavy chain (SLC3A2); and a class of ATP transporter proteins (ATP1A1, ATP1A2, ATP1A3, ATP1A4, ATP1B3, ATP2B1, ATP2B2, ATP2B3, ATP2B4) [0007]. Noyes teaches all of the above scaffold proteins and further includes BASP1, recited in claim 53 [0118].
In view of Dooley and Noyes, the scaffold limitations of claims 48,49, and 53 represent known inherent properties of exosomes, or they are components of engineered exosomes that were known to persons of skill in the art prior to the filing of the instant application. Therefore, claims 48,49, and 53 are obvious embodiments of the methods made obvious by the combined teachings of Pena, Aricha, Momen-Heravi, and Valles-Sanchez.
Conclusion
No claim is 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 DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. 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, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL C GAMETT/Primary Examiner
Art Unit 1647
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