Application of Henri Moureu and Paul Chovin

345 F.2d 595, 52 C.C.P.A. 1363

Opinions

ALMOND, Judge.

This is an appeal from the decision of the Board of Appeals affirming the rejection under 35 U.S.C. § 112 of all claims in appellants’ application.¹

The invention and its use are described by appellants in their application as follows:

“The compounds of the present invention are the 5:5/-dinitro-2:2/-dichlorohydrobenzoins conforming to the following planar formula:

which have been found to possess highly useful pharmacological properties which could not have been predicted from their chemical structure. In particular, they possess substantial anti-tubercular activity. They can also be employed in veterinary medicine against coccidioses, septicaemias of young animals, refractory purulent endometrites, mammary colibacillosis and brucellosis.” The two appealed claims ² are:

“1. As a new composition of matter a compound having the planar formula:

“2. A 5,5'-dinitro-2,2-dichloro-hydrobenzoin in the form of a crystalline product having a melting point of 222 C. (Kofler block).”

The application contains no disclosure of the utility and methods of using the claimed compounds other than that set forth above. The examiner’s sole ground of rejection was that there was an insufficient disclosure of how to use the claimed compounds under 35 U.S.C. § 112. The examiner’s answer states:

“The utility of any medicinal composition obviously depends upon the dosage and the manner of administration to the subject, yet applicants have neither disclosed nor suggested what dosages would be safe or effective nor what the lethal dosages might be. Neither is the manner of administration of the medicine to the subject been disclosed or suggested, whether by application to the skin, by inhalation, by ingestion or by injection into the body tissues. Neither would one skilled in the art be taught by knowledge of the medicinal use of a compound having an analogous chemical structure how to use the claimed products since applicants disclose that:

“ ‘The compounds of the present invention — have been found to possess highly useful pharmacological properties which could not have been predicted from their chemical structure.’ (Emphasis examiner’s.)

It is therefore clear that those skilled in the .art who desire to use the products of the invention for medicinal purposes would find it necessary to engage in extensive experimentation to determine what would be the effective and safe manner of using the products as medicines for the suggested purposes and to determine the dosages to be avoided because lethal or ineffective.”

Both the examiner and the board recognized that compliance with section 112 does not necessarily require specific recitations of use if the method of using is inherent in the description of the compound, In re Nelson, 280 F.2d 172, 47 CCPA 1031. The board held, however, that a bald assertion that the claimed compounds possess antitubercular activity would not indicate to those skilled in the medical arts the manner of effectively using the compounds.

In their brief, appellants argue that a skilled medical practitioner would know how to use their compounds.³ They rely upon In re Nelson, supra; In re Johnson, 282 F.2d 370, 48 CCPA 733; In re Adams, 50 CCPA 1185, 316 F.2d 476, and In re Hartop, 50 CCPA 780, 311 F.2d 249.

In Nelson certain intermediate steroid compounds were claimed. The application did disclose that other steroids could be made from these intermediates by chemical reactions. Although the reactions (hydrolysis, hydrogenation and oxidation) were not completely described, they were mentioned. Thus there was a “how to use” disclosure and it was found to be sufficient. There is .no “how to use” disclosure in the present case.

In Johnson the facts were similar to those here. A compound was claimed and its utility as a fungicide or insecticide was disclosed, but there was no “how to use” disclosure. Standard chemical and scientific treatises, however, indicated that insecticides or fungicides were effective in a wide variety of forms and percentages. Applying the same approach to the present case, it is noted that a standard pharmacology text⁴ indicates that commonly used antitubercular drugs should be administered in a very specific manner. Furthermore, the method of administration varies with each drug. Dosages may vary from 1 gram twice weekly for streptomycin to 12 grams a day for para-amino-salicylic acid. Some of the drugs may be administered orally, some intramuscularly, others intravenously, and a few by all of these methods. The problem of determining the method of using an antitubercular drug is so much more complex than that of using a fungicide that we cannot say that the method of use was apparent as in the Johnson case.

In Adams we held that because the claimed compound was similar to other known compounds, it would be apparent that the claimed compound could be used in the same manner as the known compounds. Here, however, the claimed compounds are apparently not similar to any known compounds. Appellants have stated that their “pharmacological properties * * * could not have been predicted from their chemical structure.”

The Hartop case considered the degree of safety which must be shown to satisfy the utility requirement of 35 TJ.S.C. § 101. The safety issue is not before us and we think that Hartop is therefore in-apposite.

It can thus be seen that none of the cases cited by appellants support their position that no “how to use” disclosure is necessary under the particular facts here present. Indeed, appellants’ attorney, at oral argument, stated that this is a case of first impression as far as he was aware and that the court would have to go further than it had ever gone before to reverse the board. We are not inclined to go that far. Appellants have not placed one iota of evidence in the record to indicate that one skilled in the art would be able to use their anti-tubercular compounds effectively without undue experimentation. Thus, we have no way of knowing whether an express “how to use” disclosure is necessary. The Patent Office says that it is. To reverse the Patent Office on the record in this case would in effect be to hold that a patent application need not indicate “how to use” a claimed chemical compound. We are bound by the first paragraph of 35 U.S.C. § 112 which requires such a disclosure.

In exchange for patent protection, a full disclosure is required. “Promotion of the useful arts takes place through the combination of * * * two factors, the doing of the work and the disclosure of the results thereof.” In re Nelson, 47 CCPA at 1046, 280 F.2d at 182, 126 USPQ at 251. It is not clear how appellants determined that their compounds have antitubercular activity unless their work involved use of the compounds against tuberculosis. Appellants must either so describe the method of use as to enable one skilled in the art to use the compounds or show that one skilled in the art would know how to use them, In -re Nelson. Appellants have done neither.

The decision of the board is therefore affirmed.

Affirmed.

Footnotes

1

. Serial No. 734,090, filed May 9, 1958 for “5,5'-Dinitro-2,2'-Diahloro-Hydroben-of.”

2

. Appellants, in their brief, withdrew the appeal to process claims 3 to 7.

3

. Appellants also argue that their compounds have in vitro utility and that it would be apparent how to achieve this utility. This argument was not raised below. Since we do not have the views of the examiner and board, we cannot properly consider it here, In re Griner, 48 CCPA 852, 287 F.2d 178.

4

. Goodman and Gilman, The Pharmacological Basis of Therapeutics (2d ed. 1955). We take judicial notice of this text at the solicitor’s request, In re Norris, 37 CCPA 876, 179 F.2d 970, 84 USPQ 458.