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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-8, and 11-20 have an effective filing date of 16JUN2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restriction
In the response filed on 7/20/2026, Applicant elected, without traverse:
Group II, claims 11-20
Status of Claims
Claims 1-8, and 11-20 are currently pending and presented for examination on the merits.
Claims 1-8 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to non-elected inventions.
Claims 9-10 are canceled.
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.
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 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.
Claims 11-12, 15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Christiano et al (US 20160058765 A1, IDS 2/17/2025).
In regard to claims 11 and 12, Christiano et al teaches a method of treating skin comprising administering INCB018424, the treatment markedly reducing epidermal thickening and dermal inflammation [Fig. 15B]. Christiano et al further teaches INCB018424 is a JAK1/2 inhibitor [0006]. Christiano et al further teaches administration by topical delivery [0006]. Christiano et al further teaches the JAK1 or JAK2 is a siRNA [0006]. Christiano et al further teaches that eukaryotic expression vector can be used to transfect cells in order to produce proteins encoded by nucleotide sequences of the vector [0176]. Christiano et al further teaches the treatment of psoriasis with topical JAK1/JAK2 inhibitors [0360].
One of ordinary skill, before the effective filing date, would have been motivated to use Christiano’s method of contacting skin with a JAK1 and/or JAK2 inhibitor by transfecting cells on the skin surface by applying siRNA topically. It would have been prima facie obvious to use Christiano’s method for a methods comprising contacting a skin cell with a JAK1 and/or JAK2 inhibitor, and transfecting the skin cell with one or more nucleic acid molecules, because Christiano teaches contacting cells with a JAK1 and/or JAK2 inhibitor. Furthermore, Christiano teaches transfecting cells using siRNA.
In regard to claim 15, Christiano et al teaches nucleic acids inserted into vectors and used in gene therapy vectors [0273].
In regard to claims 17-19, Christiano et al teaches the delivery of nucleic acids into viable cells by ex vivo, in vivo, and in vitro [0272].
In regard to claim 20, Christiano et al teaches the layers of skin comprise two layers, the epidermis and dermis [0113]. Christiano et al further teaches the epidermis layer is the outer layer of skin [0113]. Christiano et al further teaches the epidermis is 95% comprised of keratinocytes [0113].
Claims 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Christiano et al (US 20160058765 A1, IDS 2/17/2025) as applied to claims 11-12, 15, and 17-20 above, and further in view of Swindell et al (RNA-Seq Analysis of IL-1B and IL-36 Responses in Epidermal Keratinocytes Identifies a Shared MyD88-Dependent Gene Signature, Frontiers in Immunology, Vol. 9, Art. 80, pgs. 1-20, 2018).
The teachings of Christiano et al are discussed above.
Christiano et al does not specifically teach vector expressing components of a CRISPR-Cas System. However, this deficiency is made up in the teachings of Swindell et al.
In regard to claim 13, Swindell et al teaches using the CRISPR-Cas9 [Generations of Myd88-KO KCs by CRISPR/Cas9, pg. 4].
One of ordinary skill, before the effective filing date, would have been motivated to combine Christiano’s method of contacting skin with a JAK1 and/or JAK2 inhibitor by transfecting cells on the skin surface by applying siRNA topically, with Swindell method of transfecting cells using CRISPR-Cas9. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143.It would have been prima facie obvious to combine Christiano and Swindell’s method for a methods comprising contacting a skin cell with a JAK1 and/or JAK2 inhibitor, and transfecting the skin cell with one or more nucleic acid molecules using a vector expressing components of CRISPR-Cas system, because Christiano teaches contacting cells with a JAK1 and/or JAK2 inhibitor. Furthermore, Christiano teaches transfecting cells using siRNA.
In regard to claim 14, Swindell et al teaches the use of single-guide RNA (sgRNA) as a targeting sequence [Generations of Myd88-KO KCs by CRISPR/Cas9, pg. 4].
In regard to claim 16, Swindell et al teaches transfecting keratinocytes to treating a skin condition [Abstract].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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