Application of Fisher

• Decision Date: 21 September 1962
• Docket Number: Patent Appeal No. 6783.
• Citation: 307 F.2d 948,50 CCPA 1025
• Parties: Application of Joseph D. FISHER.
• Court: U.S. Court of Customs and Patent Appeals (CCPA)

50 CCPA 1025, 307 F.2d 948 (1962)

Application of Joseph D. FISHER.

Patent Appeal No. 6783.

United States Court of Customs and Patent Appeals.

September 21, 1962.

Frank T. Barber, Carl C. Batz, Chicago, Ill. (George R. Jones and Beale & Jones, Washington, D. C., of counsel), for appellant.

Clarence W. Moore, Washington, D. C. (Jack E. Armore, Washington, D. C., of counsel), for Comr. of Patents.

Before WORLEY, Chief Judge, RICH, MARTIN and SMITH, Judges, and Judge WILLIAM H. KIRKPATRICK.^*

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 "adrenocorticotrophic hormones," commonly abbreviated "ACTH." As their functional name, "adrenocorticotrophic," indicates,¹ 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.

* * * * * *

"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 adrenocorticotrophic 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 vasopressor 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 suggested that, in the functioning of the animal body, an influence was exerted upon the adrenal glands by a substance (ACTH) secreted by the pituitary gland."

Thus it appears that the prior art ACTH concentrates are useful for injection into "rats, guinea pigs, and similar animals" but, because of low potency and high contamination, in "most cases * * * cannot be tolerated by the human being."

Appellant's aim was the production of an ACTH concentrate "substantially free of" the posterior pituitary factors above mentioned with an ACTH "potency at least equal to that of the International Standard" as above defined, which would be suitable "for injection into a human being for alleviating pathological conditions" such as "forms of arthritis." It has not been questioned that appellant has described how to produce such a concentrate and that the concentrate is useful for the stated purpose.

Claim 12, considered illustrative by appellant, is as follows:²

"12. A An adrenocorticotrophic hormone concentrate having a potency at least equal to that of the International Standard, said concentrate having a posterior pituitary contamination at least as low as 0.08 unit of vasopressin activity per International unit of adrenocorticotrophin potency, and

"B being further characterized by its solubility in glacial acetic acid and phenol; by its relative insolubility in other organic solvents; by its greater stability under acid conditions than under alkali conditions; by its susceptibility to attack by proteolytic enzymes and peptidases; and by its positive reaction to the Millon and xanthoproteic tests for tyrosine, the biuret test for peptide linkages, and the ninhydrin test for free amino groups in the alpha position, the Sakaguchi test for guanidine groups, and the Hopkins-Gole and benzaldehyde tests for indole nuclei and tryptophane."

We wish first to point out that appellant's counsel stated at the oral argument of this case that the characteristics recited in part B of claim 12, supra, "are all found in the prior art" and are not relied on "to distinguish the prior art." It is apparent, therefore, that appellant relies on part A of claim 12 for whatever novelty there is in his invention as claimed.

The board affirmed the examiner's rejection of the appealed claims on each of three grounds. Since we agree with the board as to one ground of rejection, we will consider only that ground.

The examiner rejected the claims as not defining the invention with the "particularity required by 35 U.S.C. 112."

The board affirmed this rejection, finding that "the description in the claims" was not "adequate to define the compositions as required by 35 U.S.C. 112." The board found on the part of appellant "a desire to claim products in terms of their function, not limited to any particular structure." The board stated, inter alia:

"Appellant\'s claims characterize the hormone concentrate by many properties which are common to prior art compounds and differ thereover only in a statement of the lack of certain impurities giving undesired side reactions, which impurities are defined functionally only; the product is identified only as a concentrate similar to that of the prior art but differing by the absence of a particular functionally defined side reaction. The criteria set forth, other than the functional statement of the lack of an undesired side reaction, would not enable one skilled in the art to differentiate over known products, to determine if the product were old or new. * * *"

We agree with the board that the appealed claims do not satisfy the mandate of the second paragraph of 35 U.S.C. § 112 relative to "particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention."

First, we again point out that any elements of novelty in appellant's concentrate must appear in part A of claim 12.³ Appellant relies for novelty solely on a particular minimum "potency" and a particular maximum "posterior pituitary contamination."

In our opinion, the word "potency" is used in claim 12 in the sense of "ability to effect a certain result."⁴ Thus, the recitation in claim 12 that the concentrate exhibit "a potency at least equal to the International Standard" defines what that concentrate will do rather than what it is.⁵ In other words, the "potency" of appellant's concentrate is revealed only when the concentrate is either used for the intended purpose or compared by some test procedure with the "International Standard."⁶ "Potency" here is a result of use and in that sense is a functional term. Saying that appellant's concentrate is more potent than prior art concentrates⁷ is merely saying that appellant's concentrate will perform somewhat differently and, perhaps from one point of view, better than the prior art concentrates.

The recitation in claim 12 that the concentrate have "a posterior pituitary contamination at least as low as 0.08 unit of vasopressin activity per International unit of adrenocorticotrophin potency" is similarly an expression of what appellant's concentrate will do rather than what it is. It would be more accurate in discussing this particular claim recitation to say that it sets forth the maximum of what the claimed concentrate will do in this regard; included in claim 12 is a concentrate which has no vasopressin activity.⁸ We believe that the word "activity" is used in claim 12 in...