A "preliminary" statement about a "possibility" or "potential use," alongside a recommendation for continued work and a "report back" in the future, falls short of a "'definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.'"
On March 25, 2013, in Dawson v. Dawson, the U.S. Court of Appeals for the Federal Circuit (Reyna, Bryson,* Wallach) affirmed the USPTO Board of Patent Appeals and Interferences decision that awarded priority of invention to U.S. Patents No. 6,239,113 and No. 6,569,443 (Dawson and Bowman, or InSite Vision, Inc.) over U.S. patent application Serial No. 11/801,345 (Dawson, or University of California San Francisco (UCSF)), which related to treating and preventing eye infections. The Federal Circuit stated:
The definition of conception in patent law has remained essentially unchanged for more than a century. It is the "'formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.'" At that point, "all that remains to be accomplished, in order to perfect the art or instrument, belongs to the department of construction, not creation." Based on that definition, we have held that "[c]onception is complete only when the idea is so clearly defined in the inventor's mind that only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation," and that "[a]n idea is definite and permanent when the inventor has a specific, settled idea, a particular solution to the problem at hand, not just a general goal or research plan he hopes to pursue." Moreover, "[b]ecause it is a mental act, courts require corroborating evidence of a contemporaneous disclosure that would enable one skilled in the art to make the invention."
Applying these principles, we find no basis for overturning the Board's conclusion that UCSF failed to establish sole conception by Dr. Dawson. We first note, as the Board did, that the nature of the evidence presented in this case is unusual. We are asked to decide whether and when an invention formed definitely, permanently, and particularly in the mind of the alleged inventor, but to do so without any testimony from the supposed inventor himself. Instead, UCSF has focused its proof on what normally serves as corroborating evidence -- i.e., contemporaneous disclosures of the alleged conception.
UCSF contends that the WHO Report and the WHO document prove Dr. Dawson's conception and that subsequent events, most notably Dr. Leiter's preparation of an ointment for Dr. Chern, "further corroborate" it. We disagree. At best, as the Board found, the WHO Report and WHO document announce a general idea, acknowledge many of the difficulties associated with making that idea operative, and offer some thoughts on how one might proceed (including by listing a few potential delivery vehicles). The WHO document is entitled "Potential Use of Topical Azithromycin in Trachoma Control Programmes," and the WHO Report describes Dr. Dawson's presentation as a "preliminary report on the possibility of developing a topical application of azithromycin," while "recommend[ing] that [Dr.] Dawson continue to work with [others] to develop a topical application and report back at the next meeting." A "preliminary" statement about a "possibility" or "potential use," alongside a recommendation for continued work and a "report back" in the future, falls short of a "'definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.'"
The inadequacy of UCSF's showing is equally clear in the context of the specific interference counts. The limitations of the '719 count include specific concentrations, such as "0.01% to 1.0% of an azalide antibiotic" and "0.1 to 10% of a polymeric suspending agent which is a water-swellable water-insoluble cross-linked carboxyvinyl polymer which comprises at least 90% acrylic acid monomers and 0.1% to 5% crosslinking agent." As the Board found, UCSF failed to provide "evidence to suggest a complete conception of th[at] specific formulation." . . .
Nor did UCSF's evidence establish conception of the "0.01% to 1.0% of an azalide antibiotic" to be used in a suspension. The statement in the WHO document that "one obvious preparation would be an ointment like the 0.5% erythromycin ointment" and Dr. Chern's similar assertion to Dr. Leiter that they wanted to "compare [Dr. Leiter's preparation] with erythromycin 0.5% ointment" do not do so. An "ointment" is not an aqueous "polymeric suspending agent," and erythromycin is not an "azalide antibiotic." Azithromycin is an azalide antibiotic, but the Board found "no correlation between a topical formulation having 0.5% erythromycin and a topical formulation having 0.5% azithromycin" during the relevant time period. There would have been no need for Dr. Chern to send Dr. Bowman "several articles which describe different concentrations of azithromycin as used in experimental studies as well as information about the minimum inhibitory concentrations" if Dr. Dawson had already known what concentration to use. At bottom, Dr. Dawson's idea to develop a product that was "like" another product does not establish that Dr. Dawson had a "specific, settled idea [or] a particular solution" for his invention.
UCSF's proof was similarly lacking with respect to the '729 count. That count calls for "an azalide antibiotic . . . in an amount effective to treat infection in a tissue of the eye," and the Board correctly found that UCSF failed to establish that Dr. Dawson on his own determined what that amount was. Both the WHO Report and the WHO document state that the "[e]fficacy and dosing schedule of topical azithromycin will need to be determined." Moreover, the patents and patent applications all explain that "in order for a topical application to be effective, the antibiotic must be able to penetrate the desired tissue." The WHO papers make clear that Dr. Dawson did not know at that time what that would entail. . . . As the Board found, the evidence also did not show, for example, that the ointment contained azithromycin "in an amount effective to treat infection in a tissue of the eye" or "what amount of azithromycin was homogeneously distributed in the Leiter-prepared composition or whether it degraded [or] that any or sufficient azithromycin reached tissue in Chern's eyes." As such, the Board permissibly "decline[d] to accord the Chern testimony and experimental work much, let alone, controlling weight." Dr. Chern's use of the ointment, with no verified ties to Dr. Dawson, was mere experimentation, not proof that the idea of the invention was so clearly defined in Dr. Dawson's mind "that only ordinary skill would be necessary to reduce the invention to practice." In sum, we sustain the Board's conclusions with respect to the issue of conception in both interference proceedings.