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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/17/26 has been entered.
Status of Claims
Claims 1-2, 4-7, and 9-13 are pending as of the response and amendments filed on 7/17/26. Claims 3 and 8 have been canceled.
Claims 1-2 and 4-13 were previously rejected under 103 over Liggins, WO 2005007129, in view of Sarig, WO 2016174674. Applicants’ arguments filed on 7/17/26, pertaining to this rejection have been considered, and the 1.132 declaration submitted on 3/23/26 have been reconsidered, and are found persuasive. The 103 rejection is withdrawn.
Upon consideration of the claims, a new rejection under 35 USC 112(b) is made, discussed below.
Claims 1-2, 4-7, and 9-13 were examined. Claims 12-13 are rejected. Claims 1-2, 4-7, and 9-11 are allowed.
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.
Claims 12-13 are 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.
Claims 12-13 depend from claim 1 and recite “said carrier”. However, the recitation of a “carrier” is not explicitly present in claim 1. Additionally, even if the water and oily/fatty component recited in claim 1 each implicitly meet “carrier”, it is uncertain which one meets the limitation of “said carrier”. The claims are therefore indefinite as there is insufficient antecedent basis for this limitation.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the pharmaceutical composition required for administration in the instantly claimed method, comprising a compound of Formula A, water, and an oily or fatty component, wherein the amount of water is at least 40% by weight of the total weight of the formulation exhibits unexpected characteristics compared to the prior art. Liggins, WO 2005007129 (of record) represents the most relevant prior art. Liggins teaches topical formulations for treating an inflammatory skin disease, including psoriatic lesions, wherein camptothecin and derivatives thereof are exemplified as an active agent. Liggins teaches the formulations to further comprise an organic solvent, and teaches water in an amount between 30-60% by weight included within a list of recommended solvents. However, Liggins also teaches the inclusion of water in the formulation as optional, and doesn’t explicitly teach the composition is formulated such that the compound of Formula A (camptothecin) is locally present in the epidermis and/or upper dermis, as required by the instant claims.
The 1.132 declaration of Eli Sprecher, filed on 3/23/26, provides evidence that the formulation of the instant claims, comprising a compound of Formula A, water in an amount of at least 40% by weight of the total weight of the formulation, and a fatty/oily component provides 5-fold greater penetration into the epidermis, compared to a formulation comprising Formula A in the same amount, a fatty/oily component, and no water (see pp. 2-6 of declaration):
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200
400
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. The cream formulations in the above table are representative of the formulation of the instant claims, while the ointment formulation is free of water. The significantly improved penetration of the active agent (CPT-11 and SN-38) into the epidermis compared to the ointment formulation that doesn’t contain water within the claimed amount is not taught or suggested by the prior art.
Information Disclosure Statement
The IDS filed on 9/24/26 has been considered.
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
