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 .
Status of Claims
The amendments and arguments filed 26 May 2026 are acknowledged and have been fully considered. Claims 10 and 13-20 are currently pending. Claim 19 is amended; claims 1-9 and 11-12 are cancelled; no claims are withdrawn; claim 20 is new.
Claims 10 and 13-20 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular, the rejection of claim 19 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendment to the claim. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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 10 and 13-17 are MAINTAINED rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. (Current Nanoscience, 2011, Vol. 7, 523-530; of record) in view of Labhasetwar (US 10,517,934; of record).
Claim 20 is NEWLY rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. (Current Nanoscience, 2011, Vol. 7, 523-530; of record) in view of Labhasetwar (US 10,517,934; of record).
Claim 10 is drawn to a method of treating psoriasis in a subject in need thereof, said method comprising topically administering a nanoparticle to the skin of the subject, wherein said nanoparticle comprises cyclosporine, a biodegradable polymer, a surfactant emulsifier, and a plasticizer.
Claims 13-16 are drawn to the method of claim 10, wherein said nanoparticle comprises cyclosporine, poly-lactic-co-glycolic acid, dimethyl tartrate, and polyvinyl alcohol.
Claim 20 is drawn to the method of claim 10, wherein said nanoparticle consists of cyclosporine, poly-lactic-co-glycolic acid, dimethyl tartrate, and polyvinyl alcohol.
Jain et al. teach enhanced delivery of cyclosporin A (i.e., cyclosporine) via PLGA (i.e., poly-lactic-co-glycolic acid) nanoparticles (Title) for the treatment of diseases including psoriasis (Pg. 524 left column first paragraph). Jain et al. further teach in section 2.2 (Pgs. 524-525) the nanoparticles consisting of cyclosporin A, PLGA, and PVA (i.e., polyvinyl alcohol).
As such, Jain et al. teach a method of treating psoriasis in a subject in need thereof, said method comprising topically administering a nanoparticle to the skin of a subject, wherein said nanoparticle consists of cyclosporine, a biodegradable polymer (poly-lactic-co-glycolic acid), and a surfactant emulsifier (polyvinyl alcohol).
The method of Jain et al. differs from the instantly claimed method in the following ways:
the nanoparticles of Jain et al. do not comprise a plasticizer.
Yet, as to 1: Labhasetwar teaches a similar method of treating diseases including psoriasis through topically administering nanoparticles to skin of a subject, wherein the nanoparticles comprise a biodegradable polymer (col. 2 lines 26-45). Labhasetwar further teaches in col. 8 lines 59 – col. 9 line 1:
“The nanoparticles of the present invention can further comprise a plasticizer. The plasticizer may facilitate sustained release of the encapsulated compound by maintaining the structure of the nanoparticle. A plasticizer may be added to the nanoparticles to maintain the glass transition temperature above 37° C. despite a decline in molecular weight of the polymer with time. Without being bound by theory, the addition of the plasticizer allows for pores in the nanoparticle to remain open and facilitate a continuous release of the encapsulated compound.”
Labhasetwar further teach the use of dimethyl tartrate as a plasticizer in PLGA nanoparticles (Claims 15-17).
And as discussed in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, as both the PLGA nanoparticles of Jain et al. and the use of dimethyl tartrate as a plasticizer in PLGA nanoparticles of Labhasetwar are known in the art to be useful for facilitating sustained delivery of active agents from topically administered nanoparticles, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the PLGA cyclosporine nanoparticles and the use of dimethyl tartrate as a plasticizer in PLGA nanoparticles to form a nanoparticle further useful for facilitating sustained delivery of cyclosporine, with a reasonable expectation of success.
Based on all of the foregoing, claims 10, 13-16, and 20 are rejected as prima facie obvious.
Claim 17 is drawn to the method of claim 10, wherein said nanoparticle has a diameter up to 350nm.
Jain et al. further teach the nanoparticles having an average size of 163nm (Abstract), overlapping with the instantly claimed range.
As such, claim 17 is also rejected as prima facie obvious.
Claims 18-19 are MAINTAINED rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. and Labhasetwar as applied to claims 10 and 13-17 above, and further in view of Kumar et al. (JAMA Dermatology, 2016, Vol. 152, 807-814; of record).
The teachings of Jain et al. and Labhasetwar have been set forth above.
Claim 18 is drawn to the method of claim 10 wherein said psoriasis is plaque psoriasis.
Claim 19 is drawn to the method of claim 18, wherein said plaque psoriasis is severe, wherein the severity of the plaque psoriasis is determined by the Target Lesion Severity Score (TLSS).
Jain et al. and Labhasetwar do not teach the psoriasis being plaque psoriasis.
However, Kumar et al. also teach a method of treating psoriasis by topical application of cyclosporine via a nanocarrier (Abstract). Kumar et al. further teach the psoriasis being plaque psoriasis (Title) and the plaque psoriasis including severe plaque psoriasis (Abstract “Main outcomes and measures”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Jain et al. and Labhasetwar by applying the method to severe plaque psoriasis. It would have been obvious to combine the known method of Jain et al. and Labhasetwar with the known use of cyclosporine nanocarriers for treating severe plaque psoriasis to yield the predictable result of a method for treating severe plaque psoriasis, with a reasonable expectation of success.
As such, claims 18-19 are rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 26 May 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 6 of the remarks that one of ordinary skill in the art would not be motivated to combine the teachings of Labhasetwar and Jain et al. as Jain et al. already demonstrates sustained release.
This argument is not persuasive. As discussed in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
As both the PLGA nanoparticles of Jain et al. and the use of dimethyl tartrate as a plasticizer in PLGA nanoparticles taught by Labhasetwar are known in the art to be useful for facilitating sustained release of an active agent from topically administered nanoparticles, it would have been prima facie obvious to a person having ordinary skill in the art to combine these teachings to form a nanoparticle further capable of facilitating sustained release of cyclosporine.
Applicant argues on pg. 7 of the Remarks that the instantly claimed invention provides the unexpected result of faster release than the nanoparticles of Jain et al., demonstrating a release of 90% of the encapsulated cyclosporin by day 3.
It is well settled that a showing of unexpected results is generally sufficient to overcome a prima facie case of obviousness. In re Albrecht, 514 F.2d 1389 (CCPA 1975). However, as recognized by the court in In re Schulze, 346 F.2d 600 (CCPA 1965), mere arguments are not sufficient to demonstrate unexpected results. Rather, unexpected results must be established by factual evidence by comparing the claimed invention with that of the closest prior art. In re Burckel, 592 F.2d 1175 (CCPA 1979). As discussed by the court in In re De Blauwe, 736 F.2d 699 (Fed. Cir. 1994), “the absence of tests comparing [Applicant’s claimed invention] with those of the closest prior art… constitute mere argument”. In the instant case, Applicant has appropriately compared the claimed invention with that of the closest prior art (i.e., Fujita et al) and provided factual evidence which Applicant asserts establishes unexpected results of the claimed invention. In particular, Applicant asserts the claimed invention provides a greater than expected result compared with the prior art.
A greater than expected result is evidence of nonobviousness. However, as discussed by the Court in In re Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986), any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. As recognized by the court in Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991), the differences must be greater than those which would have been expected from the prior art to an unobvious extent.
In the instant case the difference is not unexpected. Park et al. (Mol. Pharmaceutics, 2021, Vol. 18, 18-32) teach various factors affecting the drug release kinetics of PLGA nanoparticles (Pg. 18 left column). Park et al. further teach that plasticizers will decrease the glass transition temperature (Tg) of the PLGA nanoparticle (Pg. 24 right column second paragraph), additionally teaching nanoparticles with a decreased Tg having significantly increased drug release rates (Pg. 24 left to right column bridging paragraph, Fig. 6). As such, one of ordinary skill in the art before the effective filing date of the claimed invention would reasonably have expected that adding the plasticizer of Labhasetwar to the nanoparticles of Jain et al. would increase the release rate.
As such the argument of unexpected results is insufficient to overcome the prima facie case of obviousness.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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