DETAILED ACTION
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 for response to restriction requirement filed 07/15/2026.
Receipt is also acknowledged for IDS filed 04/18/2024; preliminary amendment filed 06/05/2025 and amendment filed 07/15/2026.
Claims 5-8, 11, 13, 20, 26 and 29 were canceled on 06/05/2025.
Claims 18-19, 21-25 and 27-28 are canceled on 07/15/2026.
Claims 1-4, 9-10, 12 and 14-17 are pending.
Election/Restrictions
Applicant canceled claims 18-19, 21-25 and 27-28 in response to the restriction requirement leaving the claims of Group I, claims 1-4, 9-10, 12 and 14-17 pending in the application. Applicant did not elect the claims of Group I with or without traverse. Therefore, 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)).
Furthermore, applicant elected Pluronic as the specific surfactant; Polysaccharide as the gel forming polymer; Alcohol as the specific disclosed solvent; Opioid as a disclosed drug.
Applicant has requested that the restriction requirement be withdrawn. Thus, because there are no claims other than the claims of Group 1, claims 1-4, 9-10, 12 and 14-17, the restriction requirement as set forth in the Office action mailed on 05/15/2026 is hereby withdrawn as requested by applicant. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Priority
This application is a 371 of PCT/US2022/046876 filed 10/17/2022 and which claims benefit of 63/256,746 filed 10/18/2021.
Information Disclosure Statement
The IDS filed 04/18/2024 has been considered by the examiner.
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 14 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 14 uses the term “preferably” to limit in one claim, the diameter of the nanoparticle to two ranges, a broader range and a narrower range leaving the meets and boundaries of the invention uncertain in that combining a broad limitation with a narrower “preferred” limitation in the same claim confuses the reader on what is actually required.
Correction is respectfully requested.
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) 1-4, 9-10, 12 and 14-17 (1-4, 9-10, 12 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emigh et al. (US 20060177380 A1) in combination with Pedro et al. “Opioid-based micro and nanoparticulate formulations: alternative approach on pain management” in Journal of microencapsulation, Vol. 33, No. 1, pp18-29, 2016) and Aleksandra Zielinska et al., “Polymeric Nanoparticles: Production, Characterization, Toxicology and Ecotoxicology” in Molecules, 2020, 25, 3731, pp 1-20 and Taha et al., “Sustained delivery of carfilzomib by tannic acid-based nanocapsules helps develop antitumor immunity” in Nano Lett. 2019, 19(11): pp 8333-8341 (cited by applicant on form 1449).
Emigh discloses abuse deterrent formulation comprising opioid analgesic drug that is subject to abuse, gel forming polymer, surfactant and flushing agent (abstract, paragraphs [0016]-[0022]). Carbomer/Carbopol, hydroxyethyl methyl cellulose polysaccharides are some of the gel-forming polymers (paragraph [0017], [0020], [0058], [0061], [0071], [0072]). Emigh’s formulation also contains excipients and the excipients are selected to achieve good content uniformity and release the active agent as desired (paragraph [0136]). Emigh’s formulations and dosage forms are in the form of capsules/tablets (paragraph [0151]). The surfactant in Emigh is poloxamer, sodium lauryl sulfate, sorbitan monoesters and glyceryl monooleates (paragraph [0079]). The abuse deterrent formulation of Emigh is resistant to extraction such as water (required by instant claims 10 and 12) (paragraphs [0046], [0058], [0075]). In one embodiment, pharmaceutical excipient in Emigh is magnesium stearate having particle size of 450-550 microns (paragraphs [0135], [0159]) and at least Examples 1-7 disclose tablet formulations having Avicel and magnesium stearate excipients.
Pedro teaches that nanoparticulate opioid formulations in particulate systems advantageously provides for sustained and controlled delivery, superior or equivalent analgesia profile and reduced side effects and significantly increases potency and safety profiles of opioids (see the whole document with emphasis on the abstract and conclusion). Pedro also teaches opioid formulations comprised of PLURONIC (Table 6) which is trademark for poloxamers.
Aleksandra Zielinska teaches that polymeric nanoparticles (NPs) are particles having sizes that range from 1-1000 nm and they can be loaded with active compounds (see the whole document with emphasis on the abstract) and the NPs as drug carriers have the potential for controlled release, protect drugs and other molecules with biological activity against the environment , improve bioavailability and therapeutic index (introduction).
Taha teaches nanocapsule formulation of carfilzomib (CFZ) in supramolecular assembly of tannic acid (TA, polytannic acid) and iron, having the surface modified with albumin to control the release of drug; Taha envisions that the locally/intratumorally injected CFZ nanocapsules would activate antitumor immune responses resulting in systemic protection against tumors; and that Taha’s nanocapsules can retain the drug in tumors for prolonged periods, control drugs release and serve as a reservoir of tumor antigens and damage associated molecular patterns (DAMPs) (See the whole document with emphasis on the abstract, first full paragraph of page 3). A problem the Taha platform solves is the critical challenge that antiproliferative effects of chemotherapeutic agents damage not only the tumor cells but also immune cells in the tumor microenvironment which impairs the ability to mount immune responses to dying tumor cells (3rd full paragraph of page 2). Taha also teaches that nanoparticles (NPs) have been widely pursued in the delivery of chemotherapeutics and that they have been used to help disperse water-insoluble drugs and/or protect metabolically labile drugs from the hostile physiological environment and that NPs may be designed to control the drug release rate over a prolonged period facilitating metronomic delivery of chemotherapeutics (4th full paragraph of page 2). Taha also discloses that the TA stabilizes the nanoparticles (paragraph bridging pages 3 and 4) and that encapsulation of the drug CFZ enhances the metabolic stability (3rd full paragraph of page 4).
For claims 1-4, 9-10, 12, 15 and 16-17, as described above, Emigh teaches abuse deterrent formulations comprising opioid analgesic drug that is subject to abuse, gel forming polymer, surfactant and flushing agent (abstract, paragraphs [0016]-[0022]); Carbomer/Carbopol, hydroxyethyl methyl cellulose polysaccharides are some of the gel-forming polymers (paragraph [0017], [0020], [0058], [0061], [0071], [0072]); poloxamer, sodium lauryl sulfate, sorbitan monoesters or glyceryl monooleates (paragraph [0079]) are the surfactant; magnesium stearate and Avicel are excipients in the Tablets of at least examples 1-7; the abuse deterrent formulation of Emigh is resistant to extraction (paragraphs [0046], [0058], [0075]).
Emigh differs from these claims because Emigh does not teach nanoparticle and the formulation teach polytannic acid as required. However, Pedro teaches that nanoparticulate opioid formulations in particulate systems advantageously provides for sustained and controlled delivery, superior or equivalent analgesia profile and reduced side effects and significantly increases potency and safety profiles of opioids (see the whole document with emphasis on the abstract and conclusion); Aleksandra Zielinska also teaches that teaches that polymeric nanoparticles (NPs) having sizes that range from 1-1000 nm as drug carriers have the potential for controlled release, protect drugs and other molecules with biological activity against the environment, improve bioavailability and therapeutic index (introduction). Further, Taha discloses that the tannic acid (TA, polytannic acid) stabilizes the nanoparticles (paragraph bridging pages 3 and 4) and that encapsulation of the drug’s such as CFZ enhances the metabolic stability (3rd full paragraph of page 4).
Therefore, before the effective date of the invention, one having ordinary skill in the art would have been motivated to use nanoparticulate systems as the delivery platform for the opioid abuse deterrent formulation with reasonable expectation of predictably achieving sustained and controlled delivery providing superior analgesia with reduced side effects as taught by Pedro and protect drugs and other molecules with biological activity against the environment, improve bioavailability and therapeutic index as taught by Aleksandra Zielinska; and include polytannic acid in the abuse deterrent nanoparticle formulation with the expectation of predictably stabilizing the nanoparticle as disclosed by Taha,
For claim 14, the particle size of NPs ranges from 1-1000 nm according to Aleksandra Zielinska (abstract) and in section 3.2., Aleksandra Zielinska discuses that the mean diameters for NPs can range from 100 to 200 nm. The claimed range of 300 nm to 800 nm for the particle diameter in claim 14 lies between the disclosed range of 1-1000 nm. Therefore, the ordinary skilled artisan guided by the teachings of Pedro and Aleksandra Zielinska use NPs having particle diameter within the rage of 1-1000 nm including narrower ranges such as 300-800 nm or 300-500 nm that would be effective drug carrier for the intended use.
Therefore, Emigh, in combination with Pedro, Aleksandra Zielinska and Taha renders claims 1-4, 9-10, 12 and 14-17 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The following prior art is of interest: Garg et al., “Development and characterization of single step self-assembled lipid polymer hybrid nanoparticles for effective delivery of methotrexate” in RSC Adv. 2015, 5, pp62898-62999 (cited by applicant on form 1449) teaches that lipid polymer hybrid nanoparticles (LPHNPs) have emerged as promising drug deliver system to exploit drug carrier potential of liposomes and polymeric nanoparticles (NPs) (abstract, introduction). Garg further teaches that poloxamer enhances entrapment efficiency and reduces particle size of NPs (section 3.2.1 on page 62992) and that smaller sized particles efficiently escape phagocytosis and enter tumor cells with pace than their larger counterparts (first full paragraph, left column of page 62998).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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