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
Claims 1-2 and 4-13 are pending as of the response and amendments filed on 3/23/26. Claim 3 has been canceled.
The rejection of claims 9-10 and 13 under 35 USC 112(b) is withdrawn in view of the amendments.
The 103 rejection of claims 1-9 and 11-13 over Hunter; and the 103 rejection of claim 10 over Hunter in view of Johnson are withdrawn in consideration of the amendments and the 1.132 declaration filed on 3/23/26.
A new 103 rejection is made over the amended claims, discussed below.
Claims 1-2 and 4-13 were examined and are rejected.
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.
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.
Claim(s) 1-2 and 4-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liggins, WO 2005007129 A2, publ. 1/27/2005 in view of Sarig et. al., WO 2016174674 A1, publ. 11/3/2016. Both Liggins and Sarig were cited in an IDS.
Liggins teaches topical formulations for drug delivery comprising a drug and an organic solvent, wherein the drug is present in the formulation at a concentration of at least 50% of the drug’s maximum solubility (title & abstract; p. 1, lines 4-8; p. 1, line 22-p. 2, line 2). Liggins teaches an embodiment wherein the drug is an anti-inflammatory agent, with camptothecin exemplified (p. 5, lines 10-12; p. 35, line 16-p. 36, line 14; p. 84, claim 38). Liggins teaches embodiments wherein the solvent is or glycerin (p. 3, lines 7-10 and 21-22). Liggins further teaches the formulation comprises a surfactant and/or a hydrocarbon oil, with mineral oil and beeswax exemplified (p. 5, lines 1-3; p. 76, lines 21-23; p. 79, Table 3). Liggins further includes water as a recommended solvent along with glycerin, and recommends the concentration of water in the topical formulation to range between 30-60% by total weight of the formulation (p. 16, Table A). Liggins teaches the concentration of drug in the formulation to range from about 0.001 to about 10% by weight (p. 59, line 24-p. 60, line 2). Liggins teaches topical administration of the formulation to treat an inflamed skin lesion, including a psoriatic lesion (p. 6, lines 14-19; p. 65, lines 14-17; p. 85, claim 50). Liggins teaches the topical formulation is effective for delivery of a therapeutically effective amount of a drug through or into the stratum corneum (p. 5, lines 20-27; p. 6, lines 10-13). As the stratum corneum is the outermost layer of the epidermis, it would have been prima facie obvious that topical delivery of the formulation would have resulted in the compound, i.e., camptothecin being locally present in the epidermis, as recited by instant claim 8.
Liggins doesn’t explicitly teach the inflammatory skin disease, psoriasis, to be associated with expression of SAMD9 and/or EGR1.
Sarig teaches psoriasis as a chronic inflammatory disease that lacks a cure (p. 11, lines 12-13). Additionally, inflammation can be acute (p. 6, lines 10-13). Sarig further teaches inflammatory and hyperproliferative skin diseases such as psoriasis are associated with dysregulated SAMD9 and EGR1 expression/activity (p. 10, Fig. 9 description, lines 22-26; p. 11, lines 18-22).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have arrived at the instantly claimed method of treatment, in consideration of Liggins and Sarig. Liggins teaches topical drug formulations comprising a drug, such as an anti-inflammatory agent, with camptothecin exemplified, for treating inflammatory skin lesions, including psoriatic lesions. Liggins further teaches the formulation comprises a surfactant and/or a hydrocarbon oil, with mineral oil and beeswax exemplified, and includes water as a recommended solvent along with glycerin, and recommends the concentration of water in the topical formulation to range between 30-60% by total weight of the formulation. Sarig teaches inflammatory skin diseases such as psoriasis to be associated with dysregulated expression and/or activity of SAMD9 and EGR1. Therefore, one of ordinary skill in the art would have arrived at the claimed method of treating psoriasis by topical administration of a formulation comprising camptothecin, water, and an oily component, wherein the amount of water is between 40-60% by weight of the formulation, and have had a reasonable expectation of success.
Regarding instant claim 9, “wherein the pharmaceutical composition is configured or formulated such that less than 25% by weight of the topically administered active ingredient enters the blood stream or is recovered in urine and faeces”, Liggins teaches a topical formulation that includes the same ingredients as the composition administered in the instant claims, for treating the elected inflammatory skin disease associated with SAMD9 and EGR1 expression. Therefore, it would have been prima facie obvious that by administering a topical formulation that includes the same ingredients as the instant claims, for topical administration to treat the same patient population, the result of treatment would have been the same as claimed, e.g., less than 25% by weight of the topically administered camptothecin would have entered the blood stream or been recovered in urine and faeces, in the absence of evidence to the contrary.
Information Disclosure Statement
The IDS filed on 1/5/26 has been considered.
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 SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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