DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed August 18, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 (Maintained)
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 1-4, 8-9, 14, 16-17, 34-36, and 38-39 are rejected under 35 U.S.C. 103 as being as being obvious over Far et al. (ACS Omega, 2020, 5:7432-7439) in view of Cheng et al. (US 2007/0110784 A1).
Regarding claim 1, Far discloses poly(lactic-co-glycolic acid) (PLGA) particles loaded with the drug, mometasone furoate, for intranasal drug administration to treat nasal conditions (abstract; pg. 7434). The mometasone furoate is dispersed within the PLGA particles (Fig 2; pg. 7434).
Far does not teach the particles are included in a thermoresponsive gel comprising poly(N-isopropylacrylamide).
Cheng teaches a thermal reversible gel with the polymers poly(N-isopropylacrylamide) and polyethylene glycol (abstract; claim 2) [0066]. Drug delivery systems are formed by suspending drug-containing particles in the polymer composition and then injecting the composition into a specified site of a subject [0084]. Cheng teaches that this arrangement is conductive for slow release of the biologically active molecule from the gel structure [0073]. A biologically active molecule for incorporation into the polymer composition may be any which causes a physiological change or effect, such as a drug [0074]. Cheng teaches that the polymer combination allows for an implant material that is strong, modifiable and is easily reshaped or removed from the site of implantation [0017] [0043]-[0044] [0049] [0066] [0002].
Since Far generally teaches polymeric materials for drug delivery, it would have been prima facie obvious to include a thermal reversible gel with poly(N-isopropylacrylamide) and polyethylene glycol within the teaches of Far, because Cheng teaches that drug delivery systems formed by suspending drug-containing particles in a polymer composition with poly(N-isopropylacrylamide) and polyethylene glycol allows for slow release of a drug [0073]-[0074]. The ordinarily skilled artisan would have been motivated to use the polymer system with drug containing particles taught by Cheng to allow the particles to be injected into a specified site of a subject to form an implant material that is strong, modifiable and is easily reshaped or removed from the site of implantation [0017] [0043]-[0044] [0049] [0066] [0002] [0074] [0084].
Additionally, it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., a poly(N-isopropylacrylamide/polyethylene glycol gel with drug containing particles and poly(lactic-co-glycolic acid) mometasone furoate particles) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a thermoresponsive gel) to one of ordinary skill in the art. MPEP 2143.A.
Claims 2-4 are rendered prima facie obvious because Far discloses the therapeutic agent mometasone furoate (MF) (abstract; pg. 7434).
Claims 8-9 are rendered prima facie obvious because it would have been obvious to include the polymers taught by Cheng, as previously discussed, and Cheng teaches the polymer combination poly(N-isopropylacrylamide) and polyethylene glycol (claim 2) [0066].
Claim 14 is rendered prima facie obvious because Cheng discloses suspending drug-containing particles in the polymer composition and that the composition is a mixture of the components [0033] [0084] [0089]-[0097] (i.e., it would be reasonably expected that the particles would be homogeneously distributed).
Claims 16-17 and 39 are rendered prima facie obvious because Cheng discloses that the composition is in a freeze-dried (i.e., lyophilized powder) form [0091].
Claims 34 and 35 are rendered prima facie obvious because Far discloses that the particles have a size distribution from around 60 nm to around 400 nm (pg. 7434, Figure 3A). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 A.
Regarding claim 36, while the system being configured for releasing the therapeutic agent for up to four weeks is not explicitly disclosed by the prior art, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the combined teachings of the prior art disclose a system with the same components (e.g., PEG–PNIPAAm gel and PLGA particles with mometasone furoate), the properties the applicant discloses and/or claims (release up to four weeks) are necessarily present.
Claim 38 is rendered prima facie obvious because Far discloses that the PLGA has a ratio of lactide to glycolide of 50:50 (pg. 7433, Section 2.1 Materials).
Response to Arguments
Applicant's arguments filed 08/18/2026 have been fully considered but are not persuasive.
Applicant argues that the PTO has impermissibly employed hindsight to arrive at the purported combination of Far and Cheng because Cheng does not suggest any class of drugs or specific drugs, Cheng does not suggest any class of particles or specific particles, and Cheng does not suggest intranasal administration.
The Examiner disagrees. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See MPEP 2145.X.A. In the instant case, since Far generally teaches polymeric materials for drug delivery, it would have been prima facie obvious to include a thermal reversible gel with poly(N-isopropylacrylamide) and polyethylene glycol within the teaches of Far, because Cheng teaches that drug delivery systems formed by suspending drug-containing particles in a polymer composition with poly(N-isopropylacrylamide) and polyethylene glycol allows for slow release of a drug [0073]-[0074]. The ordinarily skilled artisan would have been motivated to use the polymer system with drug containing particles taught by Cheng to allow the particles to be injected into a specified site of a subject to form an implant material that is strong, modifiable and is easily reshaped or removed from the site of implantation [0017] [0043]-[0044] [0049] [0066] [0002] [0074] [0084]. Additionally, it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results, as discussed above. The knowledge was within the level of ordinary skill at the time the claimed invention was made (Far and Cheng) and does not include knowledge gleaned only from the applicant's disclosure.
Claim 37 is rejected under 35 U.S.C. 103 as being as being obvious over Far et al. (ACS Omega, 2020, 5:7432-7439) in view of Cheng et al. (US 2007/0110784 A1) and further in view of Mundari et al. (Journal of Controlled Release, 2008, 125:193–209).
The 35 U.S.C. 103 rejection over Far in view of Cheng was previously discussed.
The combined teachings of the prior art do not disclose the PLGA has a weight average molecular weight of 4 kDa to 8 kDa, as recited in claim 37.
Mundari teaches that PLGA polymers in the molecular weight range of 5–15 kDa are used for the delivery of active agents (pg. 203, right column, bottom) and that the molecular weight of PLGA influences the release characteristics (i.e., degradation time) of the delivery system (abstract; pg. 202, left column, second full paragraph).
PLGA is recognized to have different effects (i.e., degradation time) with different molecular weights used. Thus, the general condition (molecular weight of PLGA) is known in the art and the weight of PLGA is recognized to be result effective. As such, result effective variables can be optimized by routine experimentation, and it would have been prima facie obvious to optimize the molecular weight of PLGA, within the combined teachings of the prior art, to achieved the desired release characteristics. See MPEP 2144.05.
Response to Arguments
Applicant's arguments filed 08/18/2026 have been fully considered but are not persuasive.
Applicant argues that there is nothing in Mundari ameliorating the “fatal deficiency” of the asserted Far/Cheng combination.
The Examiner disagrees because the combination of Far and Cheng is not deficient expect where Mundari teaches the molecular weight of the PLGA polymers.
Claim Rejections - 35 USC § 103 (New, Necessitated by Amendment)
Claim 40 is rejected under 35 U.S.C. 103 as being as being obvious over Far et al. (ACS Omega, 2020, 5:7432-7439) in view of Cheng et al. (US 2007/0110784 A1) and further in view of Alexander et al. (European Journal of Pharmaceutics and Biopharmaceutics, 2014, 88:575-585.
Regarding claim 40, it would have been prima facie obvious to include the polymer combination of poly(N-isopropylacrylamide) and polyethylene glycol taught by Cheng, within the teachings of Far, as previously discussed.
The combined teachings of the prior art do not disclose that the polyethylene glycol has a molecular weight of 2000 to 8000.
Alexander discloses polyethylene glycol (PEG)–Poly(N-isopropylacrylamide) (PNIPAAm) based thermosensitive hydrogels (abstract) and teaches that molecular weight of PEG of 2000-20,000 significantly improves the physical and mechanical properties of hydrogels containing PEG and poly(N-isopropylacrylamide) (pg. 581, left column, bottom paragraph).
Since the combined teachings of the prior art teach a gel with the polymers poly(N-isopropylacrylamide) and polyethylene glycol, it would have been prima facie obvious to include polyethylene glycol with a molecular weight of 2000-20,000, within the combined teachings of the prior art because Alexander discloses a hydrogel with poly(N-isopropylacrylamide) and polyethylene glycol where this molecular weight of PEG is used. An ordinarily skilled artisan would have been motivated to use this molecular weight of PEG because Alexander teaches that molecular weight of PEG of 2000-20,000 significantly improves the physical and mechanical properties of hydrogels containing PEG and poly(N-isopropylacrylamide) (pg. 581, left column, bottom paragraph). Regarding the claimed molecular weight, a prima facie case of obviousness exists because of overlap, as previously discussed.
Response to Arguments
The rejection of claim 40 over Far in view of Cheng and Alexander is newly applied and has not been traversed.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
