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 .
DETAILED ACTION
Claim Status
The claim set of 21 Aug 2024 has been entered and reviewed
Claims 1-16 are pending.
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-10, directed to a composition, in the reply filed on 25 Aug 2026 is acknowledged. Applicants also elected that the dopamine active transporter targeting agent is armodafinil, the neurotrophin is BDNF, the carrier is polylactic acid, the dopamine disorder is schizophrenia and the delivery is intranasal in response to the species election requirement. The examiner notes that the election of the dopamine disorder as schizophrenia and that the delivery is intranasal are currently related to the method claims which are withdrawn.
Claims 11-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-10 are under consideration to the extent of the elected species, i.e., that the dopamine active transporter targeting agent is armodafinil, the neurotrophin is BDNF, the carrier is polylactic acid.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 Aug 2026 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The description of drawings for FIGs. 3A-3C (page 8 lines 23) states that the scale bar is 25um, however, there is not a scale bar present in FIGs 3A-3C
The description of drawings for FIGs 2A-2I, 3A-3C, and 4A-4D identifies features in the figures using color descriptors (e.g. red, green), however, the figures lack these colors as they are in black and white.
The use of the term “pluronic,” which is a trade name or a mark used in commerce, has been noted in this application at page 19. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Vitaliano et al. (US2012/0263793, published 18 Oct 2012, Document listed on IDS filed 12/13/2021) in view of Chau (US 2013/0289019, published 31 Oct 2013).
Vitaliano teaches bio-nano-plasmonic elements and platforms related to fabricating elements using one or more self-assembling elements comprised of at least one or more clathrin protein molecules (title, abstract). Vitaliano teaches that the clathrin may comprise one or more cargo elements such as pharmaceuticals, biologicals, or other nanodevices for in vivo delivery of targeted therapy to combat diseases (([0411], [0412], FIG. 2 202a-202f), [0268]). Vitaliano teaches embodiments of the invention that enter the CNS and or cross the blood brain barrier ([0785]) for delivery of one or more diagnostic or therapeutic agents such as Parkinson’s agents to targeted areas within the brain ([0804]), rendering a method of treating Parkinson’s disease as obvious. Vitaliano further teaches that the agents may be psychotropic agents used to treat conditions such as depression and schizophrenia ([0804]). Vitaliano teaches that in one embodiment, invention delivered neuroprotective cargo elements are composed of brain-derived neurotrophic factor (BDNF) ([0514], [0515], [0523]) which provides neuroprotective effects in regions of the brain adversely affected by various conditions ([0515]). Vitaliano teaches that the clathrin may include a plurality of cargo positioning and attachment molecules such as molecular tethers and ligands to attach directly cargo elements ([0220]-[0225], [0419], [0422], FIG. 2 204a-204f). Regarding claims 8-10, Vitaliano teaches that PEGylation may be used for the attachment of one or more elements. ([0225]). Vitaliano teaches an embodiment of the invention comprising either a complete clathrin protein cage or a partial protein cage ([0177]-[0180], [0190], [0191]). Vitaliano teaches that complete or partial clathrin protein cage elements have a native ability to simultaneously carry different types of cargo elements ([0303]). Vitaliano teaches that the clathrin protein molecules of the invention are nanoparticles in the range of about 1 nm to about 50 nm (claim 3). Vitaliano teaches that the invention may use the nasal cavity as a route for delivery ([0794-0795]). Vitaliano teaches that the platform may be implantable ([0328], [0826], [0888]) and teaches controlled release ([0299], [0485], [0612], [0821]), rendering obvious claims 6 and 7. Vitaliano teaches that the elements may be encapsulated in a biodegradable controlled-release polymer ([0820-0821]).
Vitaliano does not teach the inclusion of dopamine active transporter targeting agent of armodafinil (i.e. the elected species) or the inclusion of the carrier polylactic acid (i.e. the elected species of carrier). These deficiencies are made up for in the teachings of Chau.
Chau teaches methods and compositions for treating behavioral and mental disorders such as depression ([0002]). Chau teaches compositions comprising one or more therapeutic agents affecting brain reward circuitry and a pharmaceutically acceptable carrier ([0034-0035]). Chau teaches the inclusion of psychotropic antidepressants that are dopamine reuptake inhibitors such as armodafinil ([0031], [0267]). Chau teaches that active compounds may be prepared with carriers that will protect the compound against rapid elimination from the body, such as a controlled release formulation and teaches biodegradable, biocompatible polymers such as polylactic acid ([0200], [0391]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included armodafinil and polylactic acid in the clathrin nanoparticle composition of Vitaliano. The clathrin nanoparticles of Vitaliano are a drug carrier suitable for loading a variety of drug components such including psychotropic agents used to treat conditions such as depression. Armodafinil is known from Chau to be a dopamine reuptake inhibitor that is a psychotropic antidepressant. The inclusion of armodafinil thus merely represents the use of a known antidepressant drug in a clathrin carrier known for carrying drug components such as psychotropic agents for depression, and thus merely represents the use of known prior art element according to its known purpose. Regarding the inclusion of polylactic acid, polylactic acid is known from Chau as a biodegradable, biocompatible polymer that can protect compounds against rapid elimination from the body. Thus, it would have been obvious to one of ordinary skill in the art to include polylactic acid with a reasonable expectation of success as the compositions of Vitaliano are controlled release compositions that may be encapsulated in biodegradable controlled-release polymer and polylactic acid is a biodegradable, biocompatible polymer that is known for use in pharmaceutical related compositions and helps prevent rapid elimination from the body.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/093,775 in view of Vitaliano et al. (US2012/0263793, published 18 Oct 2012, Document listed on IDS filed 12/13/2021) and Chau (US 2013/0289019, published 31 Oct 2013).
The reference application recites a composition comprising a CNS targeting agent and a neurotrophic factor that are linked to a clathrin nanoparticle with PEG conjugation.
The reference application does not recite BDNF, armodafinil, a polylactic acid carrier, or a controlled release formulation implant. These deficiencies are made up for in the teachings of Vitaliano and Chau.
The teachings of Vitaliano and Chao are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included with the clathrin of the reference application BDNF, armodafinil, and polylactic acid, as part of a controlled release implant. Clathrin particles are known from Vitaliano as suitable for carrying various cargo such as BDNF and psychotropic agents used to treat conditions such as depression and to use them in controlled release applications including implants. Thus, clathrin particles are known structures for carrying drug components. Armodafinil is known from Chau to be a dopamine reuptake inhibitor that is a psychotropic antidepressant and its inclusion merely represents the use of a known antidepressant drug in a clathrin carrier known for carrying drug components such as psychotropic agents for depression, and thus merely represents the use of known prior art element according to its known purpose. Regarding the inclusion of polylactic acid, polylactic acid is known from Chau as a biodegradable, biocompatible polymer that can protect compounds against rapid elimination from the body. Thus, it would have been obvious to one of ordinary skill in the art to include polylactic acid with a reasonable expectation of success as it is obvious form Vitaliano to form clathrin controlled release compositions that may be encapsulated in a biodegradable controlled-release polymer and polylactic acid is a biodegradable, biocompatible polymer that is known for use in pharmaceutical related compositions and helps prevent rapid elimination from the body.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 7,393,924 in view of Vitaliano et al. (US2012/0263793, published 18 Oct 2012, Document listed on IDS filed 12/13/2021) and Chau (US 2013/0289019, published 31 Oct 2013).
The reference patent recites an isolated bio-nanoparticle element comprising a cage element formed from clathrin and comprising one or more types of cargo elements.
The reference application does not recite including BDNF, armodafinil, a polylactic acid carrier, linking with PEG, or a controlled release formulation implant. These deficiencies are made up for in the teachings of Vitaliano and Chau.
The teachings of Vitaliano and Chao are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included with the clathrin of the reference patent BDNF and armodafinil linked to the clathrin, and polylactic acid, as part of a controlled release implant. Clathrin particles are known from Vitaliano as suitable for carrying various cargo such as BDNF and psychotropic agents used to treat conditions such as depression and to use them in controlled release applications including implants. Thus, clathrin particles are known structures for carrying drug components. Armodafinil is known from Chau to be a dopamine reuptake inhibitor that is a psychotropic antidepressant and its inclusion merely represents the use of a known antidepressant drug in a clathrin carrier known for carrying drug components such as psychotropic agents for depression, and thus merely represents the use of known prior art element according to its known purpose. It is obvious from Vitaliano to link components to clathrin via PEG as this is a suitable means for attachment. Regarding the inclusion of polylactic acid, polylactic acid is known from Chau as a biodegradable, biocompatible polymer that can protect compounds against rapid elimination from the body. Thus, it would have been obvious to one of ordinary skill in the art to include polylactic acid with a reasonable expectation of success as it is obvious form Vitaliano to form clathrin controlled release compositions that may be encapsulated in a biodegradable controlled-release polymer and polylactic acid is a biodegradable, biocompatible polymer that is known for use in pharmaceutical related compositions and helps prevent rapid elimination from the body.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,235,062 in view of Vitaliano et al. (US2012/0263793, published 18 Oct 2012, Document listed on IDS filed 12/13/2021) and Chau (US 2013/0289019, published 31 Oct 2013).
The reference application recites a complex of clathrin triskelion, a linker and a growth factor linked via PEG and where ethe growth factor is a neurotrophic factor.
The reference application does not recite BDNF, armodafinil, a polylactic acid carrier, or a controlled release formulation implant. These deficiencies are made up for in the teachings of Vitaliano and Chau.
The teachings of Vitaliano and Chao are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included with the clathrin of the reference patent BDNF and armodafinil linked to the clathrin, and polylactic acid, as part of a controlled release implant. Clathrin particles are known from Vitaliano as suitable for carrying various cargo such as BDNF and psychotropic agents used to treat conditions such as depression and to use them in controlled release applications including implants. Thus, clathrin particles are known structures for carrying drug components. Armodafinil is known from Chau to be a dopamine reuptake inhibitor that is a psychotropic antidepressant and its inclusion merely represents the use of a known antidepressant drug in a clathrin carrier known for carrying drug components such as psychotropic agents for depression, and thus merely represents the use of known prior art element according to its known purpose. It is obvious from Vitaliano to link components to clathrin via PEG as this is a suitable means for attachment. Regarding the inclusion of polylactic acid, polylactic acid is known from Chau as a biodegradable, biocompatible polymer that can protect compounds against rapid elimination from the body. Thus, it would have been obvious to one of ordinary skill in the art to include polylactic acid with a reasonable expectation of success as it is obvious form Vitaliano to form clathrin controlled release compositions that may be encapsulated in a biodegradable controlled-release polymer and polylactic acid is a biodegradable, biocompatible polymer that is known for use in pharmaceutical related compositions and helps prevent rapid elimination from the body.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,096,901 in view of Vitaliano et al. (US2012/0263793, published 18 Oct 2012, Document listed on IDS filed 12/13/2021) and Chau (US 2013/0289019, published 31 Oct 2013).
The reference patent recites a nanoparticle comprising a clathrin triskelion linked to cargo consisting of a therapeutic or a diagnostic agent or a targeting moiety, and a masking moiety such as PEG. The therapeutic agent may be a neurotrophic growth factor and the cargo is linked via PEG.
The reference application does not recite BDNF, armodafinil, a polylactic acid carrier, or a controlled release formulation implant. These deficiencies are made up for in the teachings of Vitaliano and Chau.
The teachings of Vitaliano and Chao are described supra.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,239,743 in view of Vitaliano et al. (US2012/0263793, published 18 Oct 2012, Document listed on IDS filed 12/13/2021) and Chau (US 2013/0289019, published 31 Oct 2013).
The reference patent recites a composition comprising a clathrin triskelion and a therapeutic/diagnostic agent and the clathrin is linked to biodegradable controlled release polymers and the agents are linked to the clathrin via PEG.
The reference application does not recite BDNF, armodafinil, a polylactic acid carrier, or a controlled release formulation implant. These deficiencies are made up for in the teachings of Vitaliano and Chau.
The teachings of Vitaliano and Chao are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included with the clathrin of the reference patent BDNF and armodafinil linked to the clathrin, and polylactic acid, as part of a controlled release implant. Clathrin particles are known from Vitaliano as suitable for carrying various cargo such as BDNF and psychotropic agents used to treat conditions such as depression and to use them in controlled release applications including implants. Thus, clathrin particles are known structures for carrying drug components. Armodafinil is known from Chau to be a dopamine reuptake inhibitor that is a psychotropic antidepressant and its inclusion merely represents the use of a known antidepressant drug in a clathrin carrier known for carrying drug components such as psychotropic agents for depression, and thus merely represents the use of known prior art element according to its known purpose. It is obvious from Vitaliano to link components to clathrin via PEG as this is a suitable means for attachment. Regarding the inclusion of polylactic acid, polylactic acid is known from Chau as a biodegradable, biocompatible polymer that can protect compounds against rapid elimination from the body. Thus, it would have been obvious to one of ordinary skill in the art to include polylactic acid with a reasonable expectation of success as it is obvious form Vitaliano to form clathrin controlled release compositions that may be encapsulated in a biodegradable controlled-release polymer and polylactic acid is a biodegradable, biocompatible polymer that is known for use in pharmaceutical related compositions and helps prevent rapid elimination from the body.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
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