Application of Sichert

• Decision Date: 15 December 1977
• Docket Number: No. 77-546.,77-546.
• Parties: Application of Richard SICHERT.
• Court: U.S. Court of Customs and Patent Appeals (CCPA)

566 F.2d 1154

Application of Richard SICHERT.

No. 77-546.

United States Court of Customs and Patent Appeals.

Decided December 15, 1977.

Argued October 7, 1977.

Blythe D. Watts, Cleveland, Ohio, for appellant; James G. Watterson, Chagrin Falls, Ohio, of counsel.

Joseph F. Nakamura, Washington, D. C., for the Commissioner of Patents; Gerald H. Bjorge, Washington, D. C., of counsel.

Before MARKEY, Chief Judge, RICH, BALDWIN, LANE and MILLER, Judges.

MILLER, Judge.

This appeal is from the decision of the Patent and Trademark Office (PTO) Board of Appeals (board) rejecting claims 1-21 in application serial No. 360,935,¹ filed May 16, 1973, for "Therapeutical Composition." We reverse the rejection of claims 2-4, 6-8, 12, 13, 15, 16, 18, and 19, and affirm the rejection of claims 1, 5, 9-11, 14, 17, 20, and 21.

THE INVENTION

The therapeutical compositions embraced by the claims comprise mixtures of extracts from plants of the Umbelliferae, Liliaceae, Berberidaceae, and Solanaceae families (one extract per family) and an extract of a plant which has a tonic effect on the heart.² Claims 1 and 2 are exemplary:

1. A composition of matter for treating lymphatic congestions comprising a mixture of

(a) an extract of Umbelliferae,

(b) an extract of Liliaceae,

(c) an extract of a plant selected from the group consisting of Digitalis, Strophanthus, Convallaria and Crataegus,

(d) an extract of Berberidaceae, and

(e) an extract of Solanaceae, the ratios of a) : b) : c) : d) : e) being about 4 to 12 : 2.8 to 9 : 2 to 6.5 : 2 to 6 : 2 to 7.5.

2. The composition of matter set forth in claim 1 comprising a mixture of:

(a) an extract of an Umbelliferae selected from the group consisting of Conium maculatum, Cicuta virosa, Aethusa cynapium and Oenanthe crocata,

(b) an extract of a Liliaceae selected from the group consisting of Colchicum autumnale, Veratrum album, Aloe and Asparagi,

(c) an extract of a plant selected from the group consisting of Digitalis, Strophanthus, Convallaria and Crataegus,

(d) an extract of a Berberidaceae selected from the group consisting of Podophylli and Berberis vulgaris, and

(e) an extract of a Solanaceae selected from the group consisting of Hyoscyami, Atropa belladonna, Mandrogorae and Datura stramonium,

the ratios of extracts (a), (b), (c), (d) and (e) present being, respectively, about 4 to 12 : about 2.8 to 9 : about 2 to 6.5 : about 2 to 6 : about 2 to 7.5.

The specification discloses that the compositions are useful "against congestions in the lymphatic system" and explains that—

Lymphatic congestions are the cause of many diseases. The mixtures according to the invention have a superior activity against these congestions. They are also applicable prophylactically. By regularly applying them the clogged lymphatic vessels and lymphatic clefts are drained to such an extent that a normalization of the lymph current in the vessels and tissue clefts is recovered. In such a way the lymphatic congestions, the swelling of tissues and indurations as well as the dolor syndromes connected with them disappear in a short time more or less depending on the severity of the case. Emphasis added.

The modes of application of the compositions include oral, rectal, or parenteral, and the compositions may be in the form of capsules, suppositories, solvents, ointments, ampules, or an inhalation spray.

Dependent claims include the additional ingredients of an "ointment base," "potassium arsenite," and a "sulphur-containing amino acid." Claims 5, 14, and 20 are representative:

5. The composition of matter comprising the mixture of extracts set forth in claim 2 and from about 76.1 to about 83.3% of ointment base.

14. The composition of matter comprising the extracts set forth in claim 2 and between about 3% and about 35% of potassium arsenite.

20. The composition of matter comprising the mixture of extracts set forth in Claim 2 and from about 76.1% to about 83.3% of an ointment base containing linoleic acid in combination with a sulphur-containing amino acid and the biocatalyzer cytochrome C.

THE REJECTIONS

The board sustained the examiner's rejections of claims 1-21 under 35 U.S.C. § 101 for lack of proof of utility and under 35 U.S.C. § 112 for lack of enablement. The basis for these rejections was the underlined portion of the claim recitation: "A composition of matter for treating lymphatic congestions . . . ." Thus, the board summarized the examiner's position (with which it agreed) as follows:

The examiner's position is that the expression "lymphatic congestions" is undefined in the specification and does not appear to define a specific condition, but rather to describe a symptom which can be associated with an extremely large number of pathological conditions of varying etiology. The examiner's position is further that, because of the wide number of possible diseases involved, some of which are known to be extremely therapy resistant, the utility disclosed is inherently incredible and requires a high degree of proof of utility and a quite specific disclosure of how to use the claimed compositions with respect to the various disease states possibly contemplated in order to meet the requirements of 35 USC 101 and 112.

Regarding the section 101 rejection, it said:

Although the treatment of cancer is not expressly disclosed in the specification, the totality of the evidence of record strongly suggests that it must be at least implicitly included within the disclosure of "lymphatic congestions."

The board noted that utility was particularly lacking in claim 1, which recites only families of plants, as opposed to genuses, since "it is considered most unlikely that these varied plant types will yield the same drug extracts." It did not specifically address the examiner's rejection of all claims for failure to set forth the best mode, as required by section 112, or his rejection under section 101 for lack of proof of safety.

The board also sustained the examiner's rejection under section 112 (for lack of enablement) of claims 5, 9-11, 17, 20, and 21, based on disclosure in the specification that "ointment base" (recited in these claims) is an active part of the composition and not merely an inert carrier; and also based, in the case of claims 20 and 21, on disclosure that "sulphur-containing amino acid" is an active ingredient.

Finally, the board sustained the rejection under 35 U.S.C. § 102(b) of claim 14 over appellant's German application No. 1,931,467, published December 23, 1970, as follows:

The limitation in claim 14 "between about 3% and about 35% of potassium arsenite" does not appear in appellant's parent application, and the invention including that limitation is thus not described therein. Example 7 of the above specified published application discloses a composition which is a species within the genus claimed in appealed claim 14, and thus the claim is anticipated.

OPINION

1. Defining "Lymphatic Congestion"

The meaning of "lymphatic congestion" in appellant's specification is the threshold issue.

The specification discloses the intended use of the compositions to be the removal of "lymphatic congestions." The sections 101 and 112 rejections are based upon the construction of this term by the PTO. Although the specification does not set forth a specific definition of the term, it does disclose using the compositions for treating a symptom or condition in which the lymphatic vessels are clogged, or the lymph flow is otherwise retarded. Appellant argues that the words "lymphatic congestion" are common and well known and should be given their ordinary meaning;³ that the term, as used in the specification, is limited to simple lymphatic congestion (clogged lymph vessels) and does not extend to the causes or results of lymphatic congestion (various therapy resistant diseases).

The board, on the other hand, found "that the term is intended to include lymphatic edemas resulting from various trauma including postoperative trauma and any number of disease states, including various forms of cancer"; further, that "the totality of the evidence of record strongly suggests that it cancer must be at least implicitly included within the disclosure of `lymphatic congestion.'"

Nevertheless, we conclude that appellant's compositions are intended only for treatment of congestions or stoppages in the lymph system. The specification contains fifteen examples of such treatment. There is no mention of use in treating cancer. Appellant's brief sets forth the following explanation, which is entirely consistent with the specification and the dictionary definitions, supra note 3.

As a result of the clogging, lymph may not flow beyond the point of clogging but lymph continues to flow toward that point, thereby filling to excess with lymph the space in the tubes upstream of the point of stopage. As this overfilling continues the pressure it exerts on the walls of the tubes increases and the lymph passes through those walls, which are porous, and into the space between the cells in the surrounding flesh, thereby producing edemas and the like.

The record clearly shows that the compositions were developed for the "activation and regeneration of the lymphatic vessels and of the lymph nodes associated with them"; that one of the criteria for determining the effectiveness of the composition is the "tendency of the swellings of the tissues to decrease on account of the treatment"; that these compounds are "suited to diminish inflammatory changes of the lymphatic system and to remove congestions as well as products deposited in the lymph"; and that the result of treatment is "the effective drainage of the entire lymphatic system."

The board's finding that appellant's compositions are intended for treatment of diseases that cause or result from lymphatic congestions apparently rests on a semantical interpretation of the word "covers" in the board's statement that appellant "acknowledged" in Paper No. 8 (amendment of ...