Chapter 4. Disclosure and Enablement
Patent Act §112: Four requirements:
· Enablement: most important requirement under §112. Requires the inventor to describe her invention clearly enough so that one skilled in the art can understand it to make it and use it.
· Written description: Inventor must highlight or describe what she claims, and claims what she highlights.
· Claim definiteness: Inventor must demarcate what she claims and what is left free to the public to use.
· Best mode. An inventor must disclose to the public the best mode she knows for practicing the claimed invention.
PHOSITA: person has ordinary skill in the art.
1. “Undue Experimentation”
The claims must be commensurate with the inventor’s contribution, thus the scope of enablement must be at least roughly commensurate with the scope of claims.
The Incandescent Lamp Patent 159 U.S. 465 (1895) p. 261
Patent race in light bulb. Filaments. Three claims p262
Issue in claim 1: too broad. What had Edison done? He tried many different materials and demonstrated them inadequate.
Where a patent is claimed for such a discovery it should state the component parts of the new manufacture claimed with clearness and precision, and not leave a person attempting to use the discovery to find it out by experiment.
In re Wands 858 F.2d 731 (1988) p.275
The claim is about an immunoassay method for the detection of hepatitis B surface antigen by using high-affinity monoclonal antibodies. The issue here is not about this method, it’s about the starting material, antibody. PTO said the production of antibodies is unpredictable and unreliable so that it would require undue experimentation for one skilled in the art to make antibodies. (low rate of success, four out of 143) Wand argues it’s four out of nine, 134 were saved and not analyze could not be counted as failure.
Issue: whether appellant’s disclosure, considering the level of ordinary skill in the art as of the date of appellant’s application, would have enabled a person of such skill to make and use appellant’s invention w/o undue experimentation.
Factors in determining undue experimentation:
· Quantity of experiments necessary
· Amount of direction or guidance
· Presence or absence of working examples
· The nature of invention
· State of prior art
· Relative skill of those in that art
· Predictability of unpredictability of the art
· Breadth of the claims.
Holding: PTO’s opinion is reversed.
Dissent (Newman): Claims must be commensurate with the inventor’s contribution. Inventor must provide reasonable support for the proposed breadth of claims.
2. The Uses of Examples in the Specification
In re Strahilevitz 668 F.2d 1229 (1982) p. 286
Proceedings: PTO’s Board of Appeals’ decision was reversed by federal court.
Claim: A method for removing a hapten, antigen from the blood of a living animal.
Issue: Whether app
iscernible purpose for the console is to house the controls; 3) consistent with the disclosure, the original claim was directed to a sofa comprising “control means located upon the console to enable. . .”
· Omitted element: under this theory, the claims were invalid because they omitted an essential element originally disclosed in the specification.
A written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula or chemical name.
Regents of the Univ. of Cali. V. Eli Lilly & Co. 119 F.3d 1559 (1997) p.310
UC obtained US patent claiming disclosure of cDNA sequence for human insulin, mammalin insulin. Eli Lilly challenged the claims invalid.
Argument: A description of rat insulin is not a description of the broad classes of vertebrate or mammalian insulin cDNA. Claimant is overreaching. It required DNA itself. Try to distinguish DNA from other general compounds.
Just b/c u describe one species, it does not mean u get a whole genus.
It seems the claimant claims more than what they knew.
Allowing a broader claim, will deter subsequent inventors.