## Facts

- Patent applicants sought claims covering immunoassay methods to detect hepatitis B surface antigen (HBsAg) using high-affinity monoclonal antibodies of the IgM isotype.
- The application described standard hybridoma production: immunizing mice with HBsAg, fusing spleen cells with myeloma cells, and screening hybridoma supernatants to identify high-affinity IgM antibodies.
- The specification included experimental data and working examples from fusion and screening efforts and included a deposit of at least one hybridoma cell line.
- The examiner rejected the remaining claims under pre-AIA 35 U.S.C. § 112, first paragraph, reasoning that obtaining the claimed high-affinity IgM antibodies would require undue experimentation due to low success rates and perceived unpredictability.
- The Board of Patent Appeals and Interferences affirmed, concluding that a single deposit and the written disclosure did not enable the full scope of broad claims to all high-affinity IgM anti-HBsAg monoclonal antibodies.

## Issues

1. Whether the specification enabled a person of ordinary skill to make and use the claimed invention without undue experimentation under 35 U.S.C. § 112, first paragraph.
2. Whether routine screening to identify desired hybridomas rendered the disclosure non-enabling.
3. Whether broad generic claims to high-affinity IgM anti-HBsAg monoclonal antibodies required additional deposits or narrower disclosure to satisfy enablement.

## Decision

- The Federal Circuit reversed the Board’s enablement rejection.
- The court held the specification enabled the claimed invention; the necessary experimentation was not undue.
- The court concluded that routine screening and conventional hybridoma methods, coupled with the disclosure’s guidance and examples, allowed skilled artisans to practice the full scope without undue experimentation.
- A separate opinion agreed that additional deposits were unnecessary but would have affirmed the rejection based on concerns about claim breadth versus proof of enablement.

## Legal Principles

- Enablement requires that the specification teach skilled artisans to make and use the claimed invention without undue experimentation; some experimentation is permitted, including routine screening.
- Whether experimentation is “undue” is evaluated using nonexclusive considerations commonly stated as: (1) quantity of experimentation, (2) amount of guidance, (3) working examples, (4) nature of the invention, (5) state of the prior art, (6) skill in the art, (7) predictability, and (8) breadth of the claims.
- Broad claims are not invalid for lack of enablement solely because they exceed the disclosed examples; the question is whether skilled artisans can reach the claim scope without undue experimentation in view of the disclosure and the prior art.
- A single deposit or example can be sufficient when the disclosure and known techniques allow production of additional embodiments within the claimed genus without undue experimentation.

## Conclusion

The Federal Circuit held that a biotechnology disclosure can satisfy § 112 enablement even when it requires routine screening to locate desired monoclonal antibody-producing hybridomas, and it articulated a set of guideposts for determining when experimentation becomes “undue,” reversing the PTO’s non-enablement determination for these broad immunoassay claims.


In re Wands, 858 F.2d 731 (Fed. Cir. 1988)