Application of Joseph D. Fisher

307 F.2d 948, 50 C.C.P.A. 1025

• Court: Court of Customs and Patent Appeals
• Decided: September 21, 1962
• Docket: Patent Appeal 6783
• Status: Published

Opinions

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,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.

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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 <r-gested that, in the functioning of the animal body, an influence was. exerted upon the adrenal glands oy 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 adrenocorticotroph-ie 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 adrenocortico-trophin 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 Millón 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 guani-dine 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 i

“Appellant’s claims characterize the hormone concentrate by many properties which are common to prior art compounds and differ there-over 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 concentrates ⁷ 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 adrenocortieotrophin 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 vaso-pressin activity.⁸ We believe that the word “activity” is used in claim 12 in the sense of “Natural or normal function or operation.” ⁹ Thus, here again it is a type of performance or a result of use which appellant relies on to define and describe his concentrate.¹⁰ The contaminant itself is not .defined but rather only its function or behavior is recited in claim 12.

We believe that General Electric Co. v. Wabash Appliance Corp. et al., 304 U. S. 364, 58 S.Ct. 899, 82 L.Ed. 1402, is particularly in point here. In that case, the Court held “invalid on its face” the following claim:

“25. A filament for electric incandescent lamps or other devices, composed substantially of tungsten and made up mainly of a number of comparatively large grains of such size and contour as to prevent substantial sagging and offsetting during a normal or commercially useful life for such a lamp or other device.”

Regarding this claim, the Court stated at page 368, 58 S.Ct. at page 901:

« * -x- * fails to make a disclosure sufficiently definite to satisfy the requirements of R.S. § 4888, 35 U.S.C. § 33. That section requires that an applicant for a patent file a written description of his discovery or invention ‘in such full, clear, concise, and exact terms as to enable any person skilled in the art or science to which it appertains- * * to make, construct, compound and use the same; * * * and he shall particularly point out and distinctly claim the part, improvement, or combination which he claims as his invention or discovery.’ We may assume that Pacz [the patentee] has sufficiently informed those skilled in the art how to make and use his filament. The statute has another command. Recognizing that most inventions represent improvements on some existing article, process or machine, and that a description of the invention must in large part set out what is old in order to facilitate the understanding of what is new, Congress requires of the applicant ‘a distinct and specific statement of what he claims to be new, and to be his invention.’ [Merrill v. Yeomans, 94 U.S. 568, 570, 24 L.Ed. 235.] Patents, whether basic or for improvements, must comply accurately and precisely with the statutory requirements as to claims of invention or discovery. * * * ”

The Court found that the claimed tungsten filament was not distinguished from “the product of earlier manufacture” by the phrase “made up mainly of a number of comparatively large grains.” Then the Court stated:¹¹

“The claim further states that the grains must be ‘of such size and contour as to prevent substantial sagging and offsetting’ during a commercially useful life for the lamp. The clause is inadequate as a description of the structural characteristics of the grains. Apart from the statement with respect to their function, nothing said about their size distinguishes the earliest filaments, and nothing whatever is said which is descriptive of their contour (termed by the District Court a ‘very important element’), not even that they are irregular.

“The claim uses indeterminate adjectives which describe the function of the grains to the exclusion of any structural definition, and thus falls within the condemnation of the doctrine that a patentee may not broaden his product claims by describing the product in terms of function. [Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 256-258, 48 S.Ct. 474, 72 L.Ed. 868, and cases cited.] Claim 25 vividly illustrates the vice of a description in terms of function. ‘As a description of the invention it is insufficient and if allowed would extend the monopoly beyond the invention.’ [277 U.S. at 258, 48 S.Ct. at 479.] The Court of Appeals for the Ninth Circuit [which held the claim valid] relied on the fact that the description in the claims is not ‘wholly’ functional. * * * But the vice of a functional claim exists not only when a claim is ‘wholly’ functional, if that is ever true, but also when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty. * * * ” [Emphasis ours.]

We think that part A of claim 12 in the case at bar is comparable to that portion of the claim in the General Electric case which the Court held described “the function of the grains to the exclusion of any structural definition.” Using the language of the Court in the General Electric case, we hold that appealed claim 12 and the other claims at bar use “conveniently functional language at the exact point of novelty,” and for this reason do not particularly point out and distinctly claim the alleged invention as required by 35 U.S.C. § 112. See also In re Shortell, 173 F.2d 993, 36 CCPA 1013.¹²

In his brief, appellant relies on certain cases. His basic position seems to be that in each of these cases, the court found patentable or sustained the validity of claims “directed to the purified form of an already existing product,”¹³ and that the cases are therefore authority for holding patentable his claims. In view of our disposition of the case at bar, we do not believe any of those cases are apposite. In Kuehmsted v. Farbenfabriken of Elberfeld Co., 179 F. 701 (7th Cir. 1910), cert. denied, 220 U.S. 622, 31 S.Ct. 724, 55 L.Ed. 613 (1911); Union Carbide Co. v. American Carbide Co., 181 F. 104 (2d Cir. 1910); and In re Williams, 171 F.2d 319, 36 CCPA 756, all cited by appellant, at issue was the validity or patentability of claims which in each case recited definite chemical compounds partially in terms of systematic nomenclature or structural formula and partially in terms of physical or chemical characteristics, and not, as in the case at bar, with “functional language at the exact point of novelty.” Moreover, the form of the claims was not an issue in those cases.

In Parke-Davis & Co. v. H. K. Mulford & Co., 196 F. 496 (2d Cir. 1912), also cited by appellant, the appellate court held certain claims valid and infringed. One such claim was as follows:

“1. A substance possessing the herein-described physiological characteristics and reactions of the su-prarenal glands in a stable and concentrated form, and practically free from inert and associated gland tissue.”

Except as to certain questions of infringement and claim breadth, the appellate court expressed full concurrence with the lower court opinion upon “all the main fundamental questions.” We turn therefore to that lower court opinion, 189 F. 95 (C.C.S.D.N.Y.1911). The following at page 103 of that case is relevant to our position in the ease at bar:

“Nor do any of the claims call for only an ‘effect.’ That rule I understand to mean nothing more than that the claims must not be too abstract. I do not think that any of the claims in the patent are at all abstract, but each forms a concrete enough criterion to test the product intended. There is no claim which selects a single characteristic or function. The very phrase ‘physiological characteristics and reactions of the suprarenal glands’ refers to some 15 lines of the specification (page 2, lines 102-116), and this phrase is always coupled with at least two other differentia. That is sufficient to identify the product in my judgment in every case.”

It is not clear to us what rule of law, if any, may have been established by this part of the Parke-Davis case. In view of General Electric Co. v. Wabash Appliance Corp. et al., supra, however, we are unable to accept the Parke-Davis case as authority contrary to the position we have taken in the case at bar.

Finally, appellant has cited Merck & Co., Inc. v. Olin Mathieson Chemical Corporation, 253 F.2d 156 (4th Cir. 1958). There, in an infringement suit, certain product claims such as the following were held valid:

“1. A vitamin Bi2-active comppsition comprising recovered elaboration products of the fermentation of a vitamin Bi2-activity producing strain of Fungi selected from the class consisting of Schizomycetes, Torula, and Eremothecium, the L.L.D. activity of said composition being at least 440 L.L.D. units per milligram and less than 11 million L.L.D. units per milligram.”

It appears that such compositions were useful in treating pernicious anemia patients. The court in the Merck case rejected the “real contention of the defendant” that the claims at issue were invalid because they “cover a product of nature.”

Although the above quoted claim from the Merck case does recite “L.L.D. activity” ¹⁴ of the claimed “vitamin Bi2-active composition”, the claim also recites that the composition comprises “recovered elaboration products of the fermentation of a vitamin Bi2-activity producing strain of Fungi * * *.” It appears from the Merck opinion that before the invention there at issue, “the anti-pernicious anemia factor was known to exist only in liver,” that the patentees had discovered that this factor could also be obtained “cheaply and abundantly” by certain fermentations, and that the “claims do not cover vitamin Bi2 compositions derived from liver or any source other than the specified fermentates.”

In view of those facts, it is our opinion that the Merck case is not authority for holding patentable the claims now before us. Not only is appellant not the first to isolate an ACTH concentrate from pituitary glands but also the prior art discussed by appellant in his own specification clearly teaches the desirability of a high potency and a low posterior pituitary contamination in an ACTH concentrate intended for use in human therapy. In the Merck ease, on the other hand, the court clearly attributed considerable significance to its finding that the claim characteristic relating to specific fer-mentates was a point of novelty.

Appellant may well have made a valuable contribution to medical science. We agree with the board, however, that the appealed claims do not satisfy the requirement of 35 U.S.C. § 112.

The decision of the board is affirmed.

Affirmed.

1 . The following definition is found in Webster’s Now International Dictionary, 2d Ed. (1949):

“ — trophy * * * A combining form, * * *, denoting nutrition, nourishment, nurture, * * *.

Corresponding adjectives are formed in —trophic * *

2 . We have divided claim 12 into two parts, [A] and [B], to aid in discussion. The symbols, [A] and [B], do not appear in the claim.

3 . Appellant has not urged that there are any differences of patentable significance among the five appealed claims and we see none. Therefore, our decision as to claim 12 will be dispositive of claims 13 through 16. See footnote 5.

4 . Definition of “potency,” 1. c., Webster’s New International Dictionary, 2d Ed. (1949).

5 . According to the excerpts from appellant’s specification quoted elsewhere in this opinion, at least one prior art AOTH concentrate, that “described by Sayers, Sayers and Woodbury,” is known to have a potency “approximately that” of the International Standard. Hence the particular potency recited in claim 12 does not seem to distinguish the concentrate of that claim (nor of appealed claims 13 and 14) from this admitted prior art concentrate. However, wo note that appealed claims 15 and 16 require that the concentrates claimed therein have “a potency at least twice that of the International Standard.” This difference between claims 12-14 and claims 15 and 16 is not of significance in our disposition of this case, and our remarks concerning claim 12 apply equally to claims 15 and 16.

6 . The nature of such a test procedure is not set forth in the Patent Office record before us.

7 . See however footnote 5.

8 . It appears that “vasopressor activity” is synonymous with “vasopressin activity.” We supplement what has been quoted from the specification as to the physiological effect of this particular “activity” with the following definition from Dor-land’s Illustrated Medical Dictionary, 23rd Ed. (1957):

“vasopressin * * * It raises the blood pressure by stimulating the contraction of the muscular tissue of the capillaries and arterioles. * * * ”

9 . Definition of “activity,” 1. c., Webster’s New International Dictionary, 2d Ed. (1949).

10 . With regard to estimation of vasopres-sin activity, the specification states only that it “is determined according to the method recognized by the United States Pharmacopeia as compared with the standard preparation established thereby.”

11 . Bracketed cases cited by the Court.

12 . Unlike In re Arbeit et al., 206 F.2d 947, 41 CCPA 719, the ease at bar does not involve a combination of elements, one or more of which “may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof,” as permitted by the third paragraph of 35 U.S.C. § 112. Hence it is unnecessary in the case at bar to discuss the effect, if any, of that paragraph on the rationale of General Electric Co. v. Wabash Appliance Corp. et al., 304 U.S. 364, 58 S.Ct. 899.

13 . Appellant’s brief.

14 . It appears that “L.L.D. activity” refers to “the rate of growth of Lactobacillus lactis, Dorner,” and is a measure of “anti-pernicious anemia potencies.”