In re Fisher (307 F.2d 948, 1962)

MARTIN, Judge.

This is an appeal from a decision of the Board of Appeals of the United States Patent Office affirming the examiner’s rejection of claims 12-16, all of the claims of appellant’s application for a patent on an “Adrenal Gland Stimulating Concentrate.”

Involved here are mixtures of substances obtainable by extraction of animal pituitary glands. Certain of these substances are designated “adrenocor-ticotrophic hormones,” commonly abbreviated “ACTH.” As their functional name, “adrenocorticotrophic,” indicates, such hormones have a stimulatory effect on the cortex or outer layer of the adrenal glands. It is an “adrenocorticotrophic hormone concentrate” which is claimed in each of the appealed claims.

The following excerpt from the introductory portion of appellant’s specification is a discussion of the prior art status of pituitary gland extractions and ACTH, and is relevant to this case:

“Considerable research has been carried on in connection with the extraction of animal pituitary glands and the literature discloses various methods that have been developed for such extractions and the character of the products obtained. As a result of such investigations, extracts were prepared which were suitable for injection into rats, guinea pigs, and similar animals.

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“The potency of the hormone products obtained by such prior methods has been considerably less than standard, and generally in the nature of 50% of standard. The generally accepted standard is that which has been adopted by The Technical Advisory Committee to the Study Section for Metabolism and Endocrinology of the National Institutes of Health. This standard is approximately that of a physically-chemically pure hormone extracted from the pituitary glands and described by Sayers, Sayers and Woodbury in Endocrinology, Volume 42, No. 5, May, 1948, page 385. More recently the above-mentioned standard has been adopted as “International Standard”. One milligram of the standard (also referred to as “LAIA”) equals one International unit.

“By reason of the low potency of the adrenocorticotrophic hormone products heretofore produced and because of their relatively high content of undesirable factors, such as posterior pituitary hormones, such products have not been satisfactory for the treatment of humans. In most cases, the product has contained excess salts and undesirable active ^principles which cannot be tolerated ¡by the human being. This is further aggravated by the extremely low potency of the product.

“In the extract of animal pituitary glands, it is found that the extract contains, in addition to the adreno-corticotrophie hormones, certain undesirable factors which are tolerated only in very limited amounts by the human being. Principal among these are the posterior pituitary hormones which are generally referred to as “posterior pituitary factors” or “contaminants”. These are protinaceous [sic] material and consist mainly of oxytocic and vasopres-sor principles. Other anterior pituitary hormones are also found in the extract.

“The posterior pituitary factors containing oxytocic and vasopressor activity, if present in the injected adrenocorticotrophic extract, have an adverse effect upon the abdominal muscles, giving the patient cramps, causing an increase in the blood pressure and a change in the amount of urine secreted, and creating also a serious metabolic unbalance in the system * *

The following statement from appellant’s brief is also pertinent with regard to the prior art:

“Fisher [the appellant] does not deny that ACTH was known before he began his work. As pointed out in the introductory part of Fisher’s own specification [quoted supra], and as indicated in the prior art cited by the Examiner, certain crude mixtures containing ACTH were known before Fisher entered the field. It was also known that when these crude ACTH mixtures were injected into animals having artificially atrophied adrenals, the ACTH seemed to have a restorative and nutrient effect on the adrenals. In other words, the prior work had su