Citations

Full opinion text

WORLEY, Chief Judge.

This appeal is from the decision of the Board of Appeals affirming the rejection of claims 3, 5, 6 and 8-16 of appellants’ patent application, entitled “Compositions.”

The application relates to pharmaceutical preparations containing l-dehydro-6amethylhydrocortisone compounds as active ingredients, and a method of administering those preparations for the treatment of inflammatory conditions. The preparations include certain amounts of the active compound in association with a pharmaceutically acceptable enteral, parenteral or topical carrier. Appellants’ specification states:

In harmony with the mode of administration * * *, the composition is prepared by compounding, by conventional methods, the principal active ingredients, with any desired complementary active ingredients and supplementary ingredients.

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The said supplementary ingredients are those used in the art of compounding and are dependent upon the type of composition. * * *

Various supplementary ingredients, such as diluents, binders, water, alcohol, surfactants, and suspending agents, are said to be suitable as carriers. Claims 3 and 14 are illustrative of the therapeutic use appellants make of their hydrocortisone derivatives:

3. An enteral pharmaceutical preparation in dosage unit form comprising from about 0.5 to about 20 mg. per dosage unit of a member selected from the group consisting of l-dehydro-6a-methylhydrocortisone, the 21-acylates thereof wherein the acyl group is that of an organic carboxylic acid containing from one to twelve carbon atoms, inclusive, and the water soluble salts of the acylates and a pharmaeeutically-acceptable enteral carrier.

14. A method for the treatment of human and veterinary inflammatory conditions comprising the step of administering a pharmaceutical preparation comprising from about 0.5 to about 100 mg. of a member selected from the group consisting of l-dehydro-6a-methylhydrocortisone, the 21-acylates thereof wherein the acyl group is that of an organic carboxylic acid containing from one to twelve carbon atoms, inclusive, and the water soluble salts of the acylates and a pharmaceutically-acceptable carrier.

Appellants’ application is a continuation-in-part of their U. S. patent 2,897,-218 directed to l-dehydro-6a-methylhydrocortisone (methylprednisolone) and esters thereof. Claim 1 of that patent is of particular pertinence to the issue before us:

1. A compound of the formula:

wherein R is selected from the group consisting of llp-hydroxy and 11-keto, and wherein R' is selected from the group consisting of hydrogen and acyl, in which the acyl group is