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 1-6 are pending.
Election/Restrictions
Applicant’s election of methylphenidate as the dopamine active transporter, BDNF as the neurotrophin, Parkinsonism as the dopamine disorder, and intranasal delivery as the means of delivery in the reply filed on 24 Aug 2026 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)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 4 and 5 are withdrawn from further consideration by the examiner, pursuant to 37 CFR 1.142(b), as being drawn to a non-elected species.
Claims 1-3 and 6 are under consideration to the extent of the elected species, i.e., methylphenidate as the dopamine active transporter, BDNF as the neurotrophin, Parkinsonism as the dopamine disorder, and intranasal delivery as the means of delivery.
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 1-3 and 6 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 Pomytkin et al. (US 2015/0374745, published 31 Dec 2015).
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 ([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). 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]), rendering obvious intranasal delivery.
Vitaliano does not teach the inclusion of dopamine active transporter targeting agent of methylphenidate (i.e. the elected species). This deficiency is made up for in the teachings of Pomytkin.
Pomytkin teaches pharmaceutical compositions for use in the enhancement of cognitive function in persons suffering from a cognitive deficit (abstract, [0008]) such as Parkinson’s disease ([0023]). Pomytkin teaches the invention in use with cognitive enhancers such as agent interacting with reuptake transporters including psychostimulants ([0066]) such as methylphenidate ([0076]). Pomytkin teaches nasal administration ([0063]).
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 a method of treating a dopamine disorder such as Parkinson’s with a composition comprising a clathrin nanoparticle linked with methylphenidate and BDNF. Clathrin nanoparticles are known from Vitaliano for comprising attached pharmaceutical cargo elements that include BDNF and Parkinson’s agents and psychotropic agents. Methylphenidate is known from Pomytkin as a psychostimulant cognitive enhancer that is used in treating persons suffering from a cognitive deficit such as Parkinson’s disease. As the clathrin nanoparticles are known to be used with Parkinsons and psychotropic agents, it would have been obvious to one of ordinary skill to include methylphenidate in the composition of the method as it is a known psychostimulant cognitive enhancer associated with cognitive deficits such as Parkinson’s disease. There would be a reasonable expectation of success as its inclusion merely represents inclusion of a known psychostimulant agent in a clathrin nanoparticle which is known for carrying cargo agents such as Parkinson’s agents and psychotropic agents.
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 1-3 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-47 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).
The reference application recites a method for treating a human subject having or a t risk for developing a neurodegenerative disorder such as Parkinson’s disease by administering a composition comprising a CNS targeting agent and a neurotrophic factor that are linked to a clathrin nanoparticle and additional therapeutic agents including methylphenidate (claim 44) and intranasal delivery.
The reference application does not recite that the neurotrophic factor is BDNF (i.e. the elected species). This deficiency is made up for in the teachings of Vitaliano.
The teachings of Vitaliano 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 BDNF in the clathrin nanoparticle composition. Clathrin nanoparticles that may carry Parkinson’s agents are known from Vitaliano and BDNF is known from Vitaliano to be a suitable neurotrophin for including with clathrin particles. Thus, the inclusion of BDNF as the neurotrophic factor in the composition used in the method merely represents use of a neurotrophin known to be suitable with the obvious clathrin composition in the method and would be obvious to include to one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-16 of copending Application No. 18/811,560 in view of Vitaliano et al. (US2012/0263793, published 18 Oct 2012, Document listed on IDS filed 12/13/2021) and Pomytkin et al. (US 2015/0374745, published 31 Dec 2015).
The reference application recites a method of or treating a human subject having or at risk for developing a dopamine disorder such as Parkinson’s disease comprising administering a composition comprising a DAT targeting agent of dopamine re-uptake inhibitor, a neurotrophin and a carrier, where the DAT agent and neurotrophin are linked to a clathrin nanoparticle and delivery is intranasal.
The reference application does not recite that the DAT agent is methylphenidate or the neurotrophin is BDNF. These deficiencies are made up for in the teachings of Vitaliano and Pomytkin.
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 BDNF as the neurotrohin and methylphenidate as the dopamine re-uptake inhibitor in the composition of the method. The neurotrophin BDNF is known from Vitaliano as suitable for use with clathrin particles, rendering BDNF as an obvious neurotrophin for its known suitability and use with clathrin particles. Clathrin particles are further known from Vitaliano to be used with Parkinon’s agents and psychotropic agents and methylphenidate is known from Pomytkin as a psychostimulant cognitive enhancer that is associated with treating cognitive deficits resulting from conditions such as Parkinson’s, rendering it an obvious agent to include in the method for treating conditions such as Parkinson’s for its psychostimulant cognitive enhancement ability.
This is a provisional nonstatutory double patenting rejection.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
Prosecution Insights