Docket No.: 255183US23

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

IN RE APPLICATIONS       GROUP: 1655
OF: Marc SELNER

SERIAL NO: 10/965,073 and 11/684,869       EXAMINER: CLARK, AMY L.

FILED: October 4, 2004 and March 12, 2007, respectively

FOR: PENETRATING CARRIER, ANTI-FUNGAL COMPOSITION USING THE SAME AND METHOD FOR TREATMENT OF DERMATOPHYTES

DECLARATION UNDER 37 C.F.R. § 1.132

COMMISSIONER FOR PATENTS
ALEXANDRIA, VIRGINIA 22313

Sir:

Now comes Howard Maibach, M.D., who deposes and states that:

1. I am a graduate of Tulane Medical School and received by M.D. degree in the year 1955.
2. I have been employed by the University of California San Francisco (UCSF) Medical School for over 40 years as a doctor and professor in the field of dermatology. My laboratory at the UCSF Medical School has been actively involved in nail and skin penetration studies (see attached bibliography).
3. I am being compensated as a consultant for the preparation of this declaration at my usual consulting fee.
4. The relative inability to penetrate the toe nail and nail bed is a well documented problem in attempts to topically treat Onychomycosis (toe-nail fungus).
   
   Penlac is the only recognized FDA approved topical antifungal to treat toenail fungus. However, according to the Physician’s Desk Reference (56th edition, 2002), nail penetration of Penlac active ingredient (ciclopirox) in radiolabeled studies was 0.4 mm, as compared to the average big toenail thickness of 1-1.2 mm. In subsequent studies with enhanced technology, minimal ciclopirox penetration was documented. In the data for new drug application for approval of Penlac, no studies were performed for nail bed penetration since it did not even penetrate half-way through the nail plate on avulsed cadaver nails. There are numerous topical antifungals on the market, but none of them have been shown to extensively penetrate the nail and nail bed.
   
   The composition of Dr. Selner was tested in my lab, the skin and nail penetration laboratory of USCF Medical School. Dr. Selner has informed me that the composition was identical to the composition of the Example in his patent application, with the one exception of the addition of a small amount of yellow dye, turmeric, for visibility. In the nail penetration study, a small amount of the composition was applied only to the center of an avulsed cadaver nail to insure that no part of the composition could spread around the edge of the nail. The only way to the other side was thus through complete penetration. The test showed, by visual inspection, that the color of the spot on the convex side of the nail was the same as that on the concave side after penetration, indicating full penetration of the nail.
   
   This full penetration of the nail was unexpected, as we had not seen extensive penetration of the full thickness of a nail by any other antifungal composition tested in our lab. Further, given the difficulty that other compositions have had in extensively penetrating the nail, and the difficulty in compositions penetrating the nail in general, the fact that Dr. Selner’s composition showed such penetration was surprising. This penetration would permit Dr. Selner’s composition to penetrate the nail of a living patient to reach the fungi beneath the nail, a benefit that could not have been expected by others in this field, based upon the well known difficulty with providing penetration of the nail.
5. The undersigned petitioner declares further that all statements made herein of his own knowledge are true and that all statements made on information and belief are believed to be true; and further that theses statements were made with the knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of this application or any patent issuing thereon.
6. Further deponent saith not.