Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE KOSEI HATA, TADAYO HATA AND TOSHIYUKI MARUOKA
Appeal No. 651-82
December 16, 1987
HEARD: November 2, 1987
Application for Patent filed October 23, 1981, Serial No. 314,345. This application is a Continuation of Serial No. 085,349, filed October 16, 1979, now U.S. Patent No. 4,314,995, granted February 9, 1982; which is a Continuation of Serial No. 964,006, filed November 27, 1978, abandoned; which is a Continuation of Serial No. 772,333, filed February 25, 1977, abandoned. Pharmaceutical Lactobacillus Preparations.
Susan M. Jovanovich et al. for appellants
Primary Examiner--Blondel Hazel
Steiner and J. Smith
This is an appeal from the examiner's refusal to allow claims 5 through 50, which are all of the claims remaining in the application.
In U.S. Patent No. 4,314,995 [FN2], there appear claims directed to the treatment of various infectious diseases with a microorganism strain which is similar to conventional Lactobacillus strains in its morphological properties, but different from known strains of Lactobacillus in its nutritional requirements in that the microorganism strain is capable of growth in a low nutrition culture medium wherein conventional Lactobacillus is unable to grow and the growth of which is promoted by at least one substance selected from the group of Na2S, NH3 lower fatty acids and mixtures thereof. In addition, in the patented claims, the microorganism strain is selected from a group comprising several identified deposited strains. The claims involved in this appeal parallel the patented claims but are broader in that the microorganism strain is not confined to one of a group of identified deposited strains.
Claim 5 is illustrative and reads as follows:
5. A process for treating a patient having infection or infectious disease which comprises administering to said patient, in an amount effective to treat said infection or infectious disease, at least one microorganism strain which is similar to conventional Lactobacillus strains in its morphological properties, but different from known strains of Lactobacillus in its nutritional requirements, said strain of microorganism being able to grow in or the growth of which is promoted by a culture medium comprising (1) a low nutrition culture medium wherein conventional Lactobacillus is unable to grow, and (2) at least one substance selected from the group consisting of (a)Na2S, (b)NH3, (c) lower fatty acids and (d) mixtures thereof, said lower fatty acids not promoting the growth of conventional Lactobacillus when added to said low nutrition culture medium.
The appealed claims stand rejected under the first paragraph of 35 U.S.C. 112 on the theory that the enabling disclosure is not commensurate with the scope of protection sought. It is the examiner's position that undue experimentation would be required to locate the new microorganisms encompassed by the appealed claims, apart from the identified deposited strains.
*2 We have considered each of the arguments advanced by appellants; however, we are not persuaded of reversible error in the examiner's rejection of the appealed claims, which rejection we shall affirm.
The issue which arises in this appeal is whether appellants have disclosed in their specification sufficient information to enable one having ordinary skill in the art to obtain the undeposited microorganisms encompassed by the appealed claims without undue experimentation.
The microorganisms involved in practicing the claimed invention were not previously known to those having ordinary skill in the art, but were newly discovered by appellants. There is no clear teaching in appellants' disclosure as to where one having ordinary skill in the art might unearth such microorganisms or how to isolate them. In order to overcome the examiner's rejection, appellants presented three declarations to establish that one having ordinary skill in the art, armed with appellants' disclosure, would have recognized that the microorganisms encompassed by the appealed claims could be readily isolated from conventional Lactobacillus employing a relatively simple two step screening procedure. The examiner has not challenged the declarations. However, neither the specification nor the declarations shed any light upon the crucial issue which is whether the microorganisms encompassed by the appealed claims commonly occur with conventional Lactobacillus or rarely occur.
In In re Argoudelis, 434 F.2d 1390, 168 USPQ 99 (CCPA 1970), it was held that the deposit of a microorganism is necessary to satisfy the enablement requirement of the first paragraph of 35 U.S.C. 112 because of the difficulty involved in satisfying the statutory requirement verbally. [FN3] We do not view Argoudelis to establish deposition of a microorganism as the only way to satisfy the enablement requirement of the first paragraph of 35 U.S.C. 112. However, Argoudelis does support the proposition that deposition of a new microorganism is required if it is not commonly occurring or not shown to be obtainable from a commonly occurring microorganism by a verbally enabling disclosure. [FN4] Of particular significance is the paragraph which appears at 168 USPQ 102 and reads as follows:
"As mentioned, a unique aspect of using microorganisms as starting materials is that a sufficient description of how to obtain the microorganism from nature cannot be given. Such a description could only detail an experimental screening program similar to the screening program followed in discovering the microorganism in the first instance. If the microorganism involved were of very common occurrence, it might be found in a relatively short time, but if it were not of common occurrence, it might not be found for a very long time, if found at all. The microorganism involved here, of course, was not known and available to the workers in the art since it was newly discovered by appellants." (Emphasis supplied).
*3 In the situation before us, the specification sheds no light on whether the microorganisms embraced by the appealed claims commonly occur or rarely occur. While such microorganisms may be found with conventional Lactobacillus, it is not revealed how rarely or frequently they are found with conventional Lactobacillus. The declarations do not fill this lacuna. For example, in the declaration executed November 5, 1983, declarant states that
"one of ordinary skill in the art could readily begin with known sources of Lactobacillus microorganisms, ... and starting with such a material could readily isolate Lactobacillus microorganisms for use in the practice of ..." (Emphasis supplied)
the claimed invention. On page 3 of that declaration, second full paragraph, declarant states
"that anyone knowing where to obtain Lactobacillus microorganisms in nature can readily screen them in order to isolate microorganisms useful in the ..." (Emphasis supplied)
practice of the claimed invention. The crucial question not answered is how rarely or frequently do the microorganisms encompassed by the appealed claims occur with conventional Lactobacillus.
The subsequent declarations reveal that additional strains of appellants' microorganisms, apart from those previously deposited, were obtained employing the relatively simple screening procedure suggested in the disclosure. A specific procedure followed, in accordance with the second declaration executed September 3, 1984, involved a starting material which was, according to page 2 of that declaration, first full paragraph,
"grass such as clover, alfalfa, etc. obtained from a meadow...." (Emphasis supplied).
It may be that the particular meadow from which the grass was obtained was the same meadow in which appellants first discovered the deposited microorganisms encompassed by the claims of the patent which issued on the parent application. Conspicuously absent from any of the declarations is an indication as to how many sources of conventional Lactobacillus were investigated and not found to contain a microorganism encompassed by the appealed claims; i.e., failures. In short, we find nothing in the disclosure or in the declarations relied upon by appellants which sheds any light on the rarity of the microorganisms encompassed by the appealed claims. Cf. Tabuchi v. Nubel, 559 F.2d 1183, 194 USPQ 521 (CCPA 1977); Ex parte Benedict, 111 USPQ 354 (Bd.App.1956).
Apparently cognizant of this gap in the record, appellants, on page 23 of the Brief, state that they
"are not of the opinion that strains usable in the present invention are so rare that their isolation would amount to undue experimentation." (Emphasis supplied).
This statement implies that the microorganisms encompassed by the appealed claims are, in fact, rare. Appellants' opinion that they are not so rare as to require undue experimentation to unearth is an opinion on a legal question and is without factual support. It is, therefore, not persuasive of error on the part of the examiner.
*4 The examiner's rejection of the appealed claims is affirmed.
37 CFR 1.136(a) does not apply to the times for taking any subsequent action in connection with this appeal.
BOARD OF PATENT APPEALS AND INTERFERENCES
Saul I. Serota
Arthur J. Steiner
John D. Smith
FN1. Examiner-in-Chief Goldstein was unable to participate in the decision after the hearing. Serota, Chairman-of-the-Board, was substituted in his place. In re Bose Corp., 772 F.2d 866, 227 USPQ 1 (Fed.Cir.1985).
FN3. See, also, Ex parte Jackson, 217 F.2d 804 (Bd.App.1982).
FN4. Cf. Ex parte Forman, 230 USPQ 546 (BPAI, 1986).