BACKGROUND
Your company has been developing compositions and methods of treating a disease or condition that has evaded effective treatment in the past. Although you have striking in vitro data, the compositions and methods have not been tested in a clinical setting. You file a patent application with the United States Patent and Trademark Office (USPTO), which timely mails a First Action on the Merits, rejecting all claims as lacking utility under 35 USC 101 and not teaching how to make and use the invention under 35 USC 112. Now what?

EXECUTIVE SUMMARY
In this patent case, the USPTO Board of Patent Appeals and Interferences (Board) affirmed the rejection of claims directed to a method of treating baldness using a composition used to soften cow udders under 35 USC 112, first paragraph, for failing to teach how to make and use, or enable, the claimed invention. The Board reversed the Examiner's rejection of these claims under 35 USC 101 for requiring clinical evidence to establish the utility of the claimed invention. In affirming the rejection under 35 USC 112, the Board reasoned that claim 1, which recites "restore hair growth" means "to restore to its original state," was not supported by the specification. The Board also reasoned that claim 15, which refers to a particular mode of action of the present invention, such as the stimulation of papilla, was not enabled. The Fed. Cir. reversed the rejection of claim 1 based on the Board's definition of "restore hair growth" as being inconsistent with the meaning of that term in the art. The Fed. Cir. affirmed the rejection of claim 15 because the mechanism of action set forth in the claim was not established. The Practice Pointer to be gained from this case is that patent practitioners should carefully consider claim language that refers to a mechanism.

THE LAW
Section 101 of United States Code Title 35 provides:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title.

The first paragraph of Section 112 of United States Code Title 112 provides:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Sweeping rejections under 35 USC 101 and 35 USC 112, first paragraph, for a lack of credible utility should be made by the USPTO if the invention is directed toward inherently unbelievable undertakings or involves implausible scientific principles. Once a credible utility is established, then it becomes the burden of the USPTO to challenge a presumptively correct assertion of utility in the disclosure. After the USPTO provides evidence that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide sufficient evidence to convince such a person of the invention's utility.

IMPORTANCE OF THE CASE
This case is important because it accentuates the USPTO's burdens in making rejections under 35 USC 101 and 35 USC 112, first paragraph. This case also provides guidance as to the pitfalls of claim language that refers to a mechanism and provides persuasive arguments to overcome rejections under 35 USC 101 and 35 USC 112, first paragraph.