Application of Gardner

• Decision Date: 25 June 1970
• Docket Number: Patent Appeal No. 8311.
• Citation: 166 USPQ 138,427 F.2d 786
• Parties: Application of John Nicholson GARDNER, Anthony Maitland Roe and George Lawrence Willey.
• Court: U.S. Court of Customs and Patent Appeals (CCPA)

166 USPQ 138, 427 F.2d 786 (1970)

Application of John Nicholson GARDNER, Anthony Maitland Roe and George Lawrence Willey.

Patent Appeal No. 8311.

United States Court of Customs and Patent Appeals.

June 25, 1970.

Arthur R. Eglington, attorney of record for appellants, George J. Harding, 3rd, Joan S. Keps, Philadelphia, Pa., of counsel.

S. Wm. Cochran, Washington, D. C., for Commissioner of Patents, Leroy B. Randall, Jack Armore, Washington, D. C., of counsel.

Before RICH, Acting Chief Judge, ALMOND, BALDWIN, and LANE, Judges, and FISHER, Chief Judge, Eastern District of Texas, sitting by designation.

RICH, Acting Chief Judge.

This appeal is from the decision of the Patent Office Board of Appeals, adhered to on reconsideration, affirming the rejection of claims 1-5, all claims of application serial No. 369,591, filed May 22, 1964, for "Antidepressant Compositions and Methods of Producing Antidepressant Activity."

The Invention

Claims 1 and 2 are directed to pharmaceutical compositions "having antidepressant activity" and claims 3-5 are directed to a "method of producing antidepressant activity which comprises internally administering" certain compounds. No claim makes any mention of the subject to which the composition or compound is administered, a fact underlying one of the rejections. Underlying another rejection is the fact that the specification nowhere makes any reference to the subject of the administration of the medication, which the Patent Office herein refers to as the "host,"¹ that is to say, the recipient of the medication.

The invention here resided in appellants' alleged discovery of the antidepressant activity in 2-aminomethyl-1, 3-benzodioxole compounds. In view of the nature of the rejections, we need not consider these compounds further. No references are relied on. No objection has been made as to the novelty or utility of the compositions claimed or to the novelty or operativeness of the methods claimed, or to the unobviousness of either, and patentability can be assumed provided the specification and claims comply with the statute.

The Rejections

The rejections before us, as affirmed by the board, are stated in the examiner's Answer as follows:

* * * Claims 3-5 stand rejected as failing to define and particularly point out the invention as required by 35 U.S.C. 112. Claims 3-5 are indefinite in the omission of a host. They are indefinite as to whom the "administering" is to.

Claims 1-5 stand rejected as being based on a defective specification in that it fails to teach one skilled in the art how to use the invention as required by 35 U.S.C. 112. There is not one specific embodiment of a contemplated host. While dosages are recited on page 6 of the specification and in the claims, they are (1) not related to any host nor (2) are the dosages related to body weight of a host. The question is not one of obviousness, but a failure to "set forth the best mode contemplated" (35 U.S.C. 112).

The examiner's reference to "obviousness" was not the obviousness of the claimed invention but was a reply to appellants' argument that, notwithstanding the total absence from the specification of any mention of a host, it would be obvious to those of ordinary skill in the medical art not only that the host would be a human or other animal but what the dosage should be. After briefly answering appellants' contentions, the examiner concluded his Answer by saying:

The indefiniteness of the claims in the omission of a host clearly follows from the indefiniteness of the disclosure.

In affirming, the board first found that appellants' specification did not contain a disclosure which satisfies the requirements of the first paragraph of 35 U.S.C. 112 and concluded with this paragraph:

In accordance with the foregoing discussion, the rejection of claims 1 through 5 under the first paragraph of 35 U.S.C. 112 must be sustained. The additional rejection of claims 3, 4, and 5 under the first sentence of the second paragraph of 35 U.S.C. 112 does not require any extended additional discussion. Insofar as the disclosure is incomplete regarding the host, such indefiniteness also attaches to claims 3, 4, and 5, but we are not called upon to rule on the propriety of the method claims if the specification were adequate to satisfy the requirements of the first paragraph of 35 U.S.C. 112.

The decision of the Examiner is affirmed.

The Rejection for Claim Indefiniteness

We will first consider the rejection of claims 3-5 on the ground that they — the claims per se — do not comply with the second paragraph of section 112 because they are indefinite, or, in the examiner's terms, because they do not point out any "host."

We are unable to say whether the board affirmed this rejection. It said it was not called upon to rule on the propriety of claims 3-5 if supported by an adequate specification; at the same time it found the specification inadequate and held that its "indefiniteness," in failing to specify any host and in not relating dosage to any host, "attaches" to claims 3-5. Whether or not the board sustained this rejection, we reverse it. We find the claims definite.

While it is true that there is no reference in any claim to a host, it is entirely clear to us that appellants' invention or discovery was in allegedly finding that the group of compounds here involved possess antidepressant activity. This has not been challenged by the Patent Office. It also seems clear to us that pharmaceutical compositions (i. e., one of the compounds in a suitable pharmaceutical carrier) having antidepressant activity would find their primary use as medication for humans with a possibility that they might find some veterinary use in other animals. Appellants say in their arguments — though not in their application — that while there is no present veterinary use known to them, if one should turn up it would be within their claims. The same observations apply to methods of producing antidepressant activity, as in claims 3-5. We do not find any indefiniteness in any of the claims by reason of their failure to name a host. They are merely broad in this respect and cover the composition and the method when administered or applied to any host capable of enjoying the benefits of an antidepressant drug. Breadth is not indefiniteness.

A similar situation obtains with respect to the dosage limitations of the claims. The two composition claims call for dosage units of from about 10 mg. to about 150 mg., and from about 10 mg. to about 100 mg. of the active ingredient, respectively. These ranges are perfectly definite. Claim 3 calls for administering "an effective amount," which, though broad, is not indefinite. Where the invention resides in finding the activity rather than in discovering some critical range or the like, we have approved of such broad definitions of quantity or dosage. In re Caldwell, 319 F.2d 254, 50 CCPA 1464 (1963); compare In re Halleck, 422 F.2d 911, 57 CCPA (1970). Claims 4 and 5 call for "daily dosages" in the ranges 10 to 450 mg. and 10 to 300 mg., respectively. They are enormously wide ranges but there is nothing indefinite about them.

The Rejection for Inadequate Disclosure

We turn now to the other rejection which is based on the inadequacy of the disclosure under the first paragraph of section 112. Appellants say their invention is in the discovery of the antidepressant activity in a group of compounds. They are not claiming the compounds. In effect, by claiming pharmaceutical compositions "having antidepressant activity" and methods "of producing antidepressant activity" which consist in administering the compounds, they are claiming in terms of use. It behooves them, therefore, to disclose how to use, as section 112 ordains, "in such full, clear, concise, and exact terms as to enable any person skilled in the art * * * to * * * use" their invention. Their invention resides in using drugs to alleviate depression. The question is whether they have disclosed how to do this.

The undisputed fact is that the specification nowhere adverts to any recipient of the antidepressant drugs. Neither man nor beast is mentioned — there is no reference to a host. There are four consecutive paragraphs of the specification and one "example" collectively relating to dosage and administration techniques which can be summarized as saying that the compounds can be put up in all the usual ways, as solids, powders, solutions, and suspensions; in tablets, lozenges, troches, capsules, or ampules; to be administered orally or parenterally; and the carrier may include a time delay material. Whatever the nature of the dosage unit, it may contain anywhere from 10 mg. to 150 mg. of the...