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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 23 February 2024 and 22 August 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group III drawn to a method of treating psoriasis in the reply filed on 28 October 2025 is acknowledged.
Claims 1, 6-9, and 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 28 October 2025.
Claims 10 and 13-19 are examined on the merits herein.
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 19 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.
The term “severe” in claim 19 is a relative term which renders the claim indefinite. The term “severe” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear which score is being used to determine the severity of the plaque psoriasis e.g., DLQI, TLSS, PASI as discussed in the instant specification on pg. 17. As such, one of ordinary skill in the art would not be able to determine the exact metes and bounds of the claim, rendering the claim indefinite.
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.
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 10 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. (Current Nanoscience, 2011, Vol. 7, 523-530) in view of Labhasetwar (US 10,517,934 cited on Applicant’s IDS filed 23 February 2024).
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.
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 comprising 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 comprises 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 comprises 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).
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. to include a plasticizer comprising dimethyl tartrate as taught by Labhasetwar. It would have obvious to use the known technique of including a plasticizer in PLGA nanoparticles to improve the method of Jain et al. in the same way, to facilitate sustained release of the encapsulated compound, with a reasonable expectation of success.
Based on all of the foregoing, claims 10 and 13-16 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 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).
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.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611