Court Opinion

ID: 9478229
Source: CourtListenerOpinion
Date Created: 2023-08-05 06:43:24.273376+00
Date Added: 2024-06-11T17:46:18.497362
License: Public Domain

PAULINE NEWMAN, Circuit Judge,
concurring in part, dissenting in part.
A
I concur in the court’s holding that additional samples of hybridoma cell lines that produce these high-affinity IgM monoclonal antibodies need not be deposited. This invention, as described by Wands, is not a selection of a few rare cells from many possible cells. To the contrary, Wands states that all monoclonally produced IgM antibodies to hepatitis B surface antigen have the desired high avidity and other favorable properties, and that all are readily preparable by now-standard techniques.
Wands states that his United States Patent No. 4,271,145 describes fully operable techniques, and is distinguished from his *741first four failed experiments that are referred to in the Rule 132 affidavit. Wands argues that these biotechnological mechanisms are relatively well understood and that the preparations can be routinely duplicated by those of skill in this art, as in Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1380, 231 USPQ 81, 94 (Fed.Cir.1986), cert. denied, — U.S. -, 107 S.Ct. 1606, 94 L.Ed.2d 792 (1987). I agree that it is not necessary that there be a deposit of multiple exemplars of a cell system that is readily reproduced by known, specifically identified techniques.
B
I would affirm the board’s holding that Wands has not complied with 35 U.S.C. § 112, first paragraph, in that he has not provided data sufficient to support the breadth of his generic claims. Wands’ claims on appeal include the following:
19. Monoclonal high affinity IgM antibodies immunoreactive with HBsAg determinants, wherein said antibodies are coupled to an insoluble solid phase, and wherein the binding affinity constant of said antibodies for said HBsAg determinants is at least 109 M-1.
26. Monoclonal high affinity IgM antibodies immunoreactive with HBsAg determinants wherein said antibodies are detectably labelled.
Wands states that he obtained 143 “high binding monoclonal antibodies of the right specificity” in the successful fusions; although he does not state how they were determined to be high binding or of the right specificity, for Wands also states that only nine of these 143 were tested.
Of these nine, four (three from one fusion and one from another fusion) were found to have the claimed high affinity and to be of the IgM isotype. Wands states that the other five were either of a different isotype or their affinities were not determined. (This latter statement also appears to contradict his statement that all 143 were “high binding”.)
Wands argues that a “success rate of four out of nine”, or 44.4%, is sufficient to support claims to the entire class. The Commissioner deems the success rate to be four out of 143, or 2.8%; to which Wands responds with statistical analysis as to how unlikely it is that Wands selected the only four out of 143 that worked. Wands did not, however, prove the right point. The question is whether Wands, by testing nine out of 143 (the Commissioner points out that the randomness of the sample was not established), and finding that four out of the nine had the desired properties, has provided sufficient experimental support for the breadth of the requested claims, in the context that “experiments in genetic engineering produce, at best, unpredictable results”, quoting from Ex parte Forman, 230 USPQ 546, 547 (Bd.Pat.App. and Int.1986).
The premise of the patent system is that an inventor, having taught the world something it didn’t know, is encouraged to make the product available for public and commercial benefit, by governmental grant of the right to exclude others from practice of that which the inventor has disclosed. The boundary defining the excludable subject matter must be carefully set: it must protect the inventor, so that commercial development is encouraged; but the claims must be commensurate with the inventor’s contribution. Thus the specification and claims must meet the requirements of 35 U.S.C. § 112. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 23-24 (CCPA 1970).
As the science of biotechnology matures the need for special accommodation, such as the deposit of cell lines or microorganisms, may diminish; but there remains the body of law and practice on the need for sufficient disclosure, including experimental data when appropriate, that reasonably support the scope of the requested claims. That law relates to the sufficiency of the description of the claimed invention, and if not satisfied by deposit, must independently meet the requirements of Section 112.
Wands is not claiming a particular, specified IgM antibody. He is claiming all such monoclonal antibodies in assay for hepatitis B surface antigen, based on his teaching that such antibodies have uniformly reproducible high avidity, free of the known *742disadvantages of IgM antibodies such as tendency to precipitate or aggregate. It is incumbent upon Wands to provide reasonable support for the proposed breadth of his claims. I agree with the Commissioner that four exemplars shown to have the desired properties, out of the 143, do not provide adequate support.
Wands argues that the law should not be “harsher” where routine experiments take a long time. However, what Wands is requesting is that the law be less harsh. As illustrated in extensive precedent on the question of how much experimentation is “undue”, each case must be determined on its own facts. See, e.g., W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1557, 220 USPQ 303, 316 (Fed.Cir.1983), cert. denied, 469 U.S. 851, 105 S.Ct. 172, 83 L.Ed.2d 107 (1984); In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 218 (CCPA 1976); In re Cook, 439 F.2d 730, 734-35, 169 USPQ 298, 302-03 (CCPA 1971).
The various criteria to be considered in determining whether undue experimentation is required are discussed in, for example, Fields v. Conover, 443 F.2d 1386, 170 USPQ 276 (CCPA 1971); In re Rainer, 347 F.2d 574, 146 USPQ 218 (CCPA 1965); Ex parte Forman, 230 USPQ at 547. Wands must provide sufficient data or authority to show that his results are reasonably predictable within the scope of the claimed generic invention, based on experiment and/or scientific theory. In my view he has not met this burden.