“Substantive Advice for Research Institutions to Comply with the Written Description Requirement”
Quarles & Brady Research Institutions Update 04/01/10 By Gavin J. Milczarek-Desai, Keith H. Heidmann
Research institutions have become increasingly concerned with the application of the “written description” requirement by the United States Patent and Trademark Office (“USPTO”) and the courts, particularly in the so-called unpredictable arts such as biotechnology and for claims that broadly recite a function without reciting specific steps or structures used to perform the function. Specifically, research institutions have argued that the requirement, which requires patent applicants to disclose in the patent specification examples of sufficient number and detail to show “possession” of what is claimed in the patent, prevents research institutions from obtaining claims of a breadth appropriate to the societal importance of pioneering inventions.
On March 22, 2010, research institutions hoping for the elimination of the written description requirement were disappointed; the Federal Circuit reaffirmed the existence of a written description requirement that is distinct from enablement under Section 112 of the Patent Act. See Ariad Pharmaceuticals, Inc. v. Eli Lilly & Company, Case No. 2008-1248 (Fed. Cir. 2010). Given that the status quo of separate requirements for written description and enablement has been maintained by this decision, research institutions will find it useful to review the written description requirement in light of both Federal Circuit case law and the USPTO written description guidelines contained in section 2163 of the Manual of Patent Examining Procedure (“MPEP”) and consider the substantive practice points provided here.
What Type of Claims are at Issue?
Although the court found as a threshold issue that the written description requirement exists, it also noted that satisfying the requirement is fact-specific, and that there is no bright line rule for its satisfaction. Id at p. 24. Thus a review of the facts of the case may prove instructive.
The inventors discovered that the biomolecule NF-kB is produced by cells under certain circumstances, and that it can be harmful if overproduced. The patent at issue had broad functional claims reciting the step of “reducing NF-kB activity.” Although the application provided a brief general description of three types of compounds that supposedly could be used to reduce NF-kB activity, only one type, a so-called “decoy molecule,” was described with any specificity. The claims were found to be invalid because the written description did not demonstrate that the applicant “possessed the claimed method by sufficiently disclosing molecules capable of reducing NF-kB activity...” Id. at 31. Furthermore, the state of the art at the time of filing was “primitive and uncertain” leaving the applicant with “insufficient supply of prior art knowledge with which to fill the gaping hole in its disclosure.”
Furthermore, the court stated in general that “[t]he problem [of inadequate written description] is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”
What Constitutes an Adequate Written Description?
Guidance is open-ended at best. Prior case law affirmed in the Ariad caseoffers the following general framework:
- “The descriptive text needed to meet the written description requirement varies with the nature and scope of the invention at issue and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005).
- “[the description must] clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562-63 (Fed. Cir. 1991) (internal citations omitted).
- “The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention.” Regents of the University of California v. Eli Lilly & Co., 119 F. 3d 1559, 1568 (Fed. Cir. 1997).
The court describes an adequate written description in terms of “possession as shown in the disclosure” of the claimed subject matter that requires “an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Ariad at p. 24. At the very least, a patent specification must include some detailed description (preferably of multiple embodiments) of what the invention is or how a claimed function is achieved (and not solely what the invention does or what it could be).
Practice Points for Research Institutions to Consider in Response to Federal Circuit Decision
- Draft claims of varying scope including at least one “picture claim” that is directed to each explicitly disclosed embodiment. If broader generic claims are desired, disclose as many multiple detailed specific embodiments as possible. Clearly depict the claimed invention in drawings and/or sequence listings and/or descriptions of method steps and step components; if biological matter is claimed, make a deposit of said matter (See 37 CFR 1.801-1.809).
- Establish a “check list” against which claims are compared for at least description, but preferably description and examples (actual rather than prophetic examples if possible) of all claimed elements, method steps and step components not known in the art.
- Consider filing provisional applications (so that they will not be published or count against patent term) directed to initial findings and follow-up with additional provisional applications with broader claims supported by additional disclosure so as to form an overlapping application "portfolio" that serves as the basis for non-provisional applications (rather than attempting to describe and claim everything in one application).
- Is the claim for a genus or species? If claim is drawn to a genus, does the art indicate substantial variation among the species within the genus? Is there a representative number of species disclosed or common structural element? According to MPEP 2163, a representative number of species “depends on whether one of skill in the art would recognize… possession of the necessary common attributes or features of the elements possessed by the members of the genus.” Review Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, 1, “Written Description” Requirement, 66 Fed. Reg. 1099, 110501106 (Jan. 5, 2001).
- Check with inventor(s) regarding the “state of the art” when responding to Office Actions, as it could be that formerly “unpredictable” areas may, as of the application filing date, be more routine (i.e., converting an amino acid sequence into all the DNA sequences that can encode it), such that a detailed description is unnecessary (being mindful, of course, to very narrowly address a written description rejection and not to make general admissions as to what is known or obvious in the art).