Nelson v. Bowler, Appeal No. 79-630.
| Decision Date | 06 November 1980 |
| Docket Number | Appeal No. 79-630. |
| Citation | 626 F.2d 853 |
| Parties | Norman A. NELSON, Appellant, v. Jean BOWLER et al., Appellees. |
| Court | U.S. Court of Customs and Patent Appeals (CCPA) |
Robert A. Armitage, Kalamazoo, Mich., and Thomas J. Macpeak, Washington, D.C., for appellant; Peter D. Olexy, Washington, D.C., of counsel.
Paul N. Kokulis, Washington, D.C., for appellees; William T. Bullinger and J.D. Atkinson, of counsel.
Before MARKEY, Chief Judge, RICH, BALDWIN, and MILLER, Judges, and RE, Judge.*
This appeal is from the decision of the United States Patent and Trademark Office (PTO) Board of Patent Interferences (board) awarding priority on all four counts to Bowler et al. (Bowler), the senior party. We reverse.
This interference involves two applications, serial No. 252,030, filed by appellant Nelson May 10, 1972, for "Composition and Process" and serial No. 474,608, filed by Bowler May 30, 1974, as a continuation of serial No. 248,717 filed April 28, 1972, for "Cyclopentane Derivatives." Appellee was accorded the benefit of an application filed in Great Britain on May 11, 1971, under 35 U.S.C. § 119, and was designated senior party. Only Nelson took testimony.
The real parties in interest are Upjohn Company, assignee of Nelson, and Imperial Chemical Industries, Limited, assignee of Bowler.
Three counts remain in this appeal.1 Counts 2 and 4 describe 16-phenoxy-substituted prostaglandins (PG's) which are admitted to be structurally related to known, naturally-occurring prostaglandins commonly designated PGF2 and PGE2.2 Count 1 is directed toward intermediates used to prepare the 16-phenoxy PG compounds of counts 2 and 4.
Naturally occurring PG's allegedly had recognized value in pharmacology at the time the present invention was made. Both parties stated as much in their respective specifications. Effects such as smooth muscle stimulation and blood pressure modulation were said to be reflected in various commercial applications. For example, labor induction or abortion was attributed to uterine smooth muscle stimulation caused by administration of PG's. Modification of blood pressure, on the other hand, was purportedly useful in treating either shock or hypertension since natural PG's can either raise or lower blood pressure.
The issue is whether Nelson has shown at least one utility for counts 1, 2, and 4 which sufficiently establishes an actual reduction to practice before the critical date of May 11, 1971. Specifically, is a practical utility manifested in testing 16-phenoxy PG's for their stimulation of smooth muscle tissue from gerbil colons and their modulation of blood pressure in rats?
Two tests conducted at Upjohn before the critical date are relied upon by appellant to prove practical utility. They are referred to as the rat blood pressure (BP) test and the gerbil colon smooth muscle stimulation (GC-SMS) test. The comparison standards for both were selected from naturally occurring PG's, i. e., PGE1 and PGF2, having known blood pressure and smooth muscle stimulation responses.
In the BP test, the blood pressure of anesthetized rats recorded on a polygraph chart to determine whether an injected compound had any effect. Responses were categorized as either a depressor (lowering) effect or a pressor (elevating) effect. Calibration was supposedly achieved by comparing an unknown analog PG versus either a standard natural PG depressor, such as PGF2, or a standard natural PG pressor, such as PGE1. Each rat was given successive PG's to test. Allowance was made for the blood pressure to approach a normal level before administering another PG.
The tested compounds, labeled 38980 and 38669, were both reported to give an atypical or biphasic response. That is, both initially depressed the rat's blood pressure before raising it. The depressor effect was a temporary manifestation lasting several seconds. The subsequent pressor effect, however, was a strong response lasting several hours. Nelson exhibits 27 and 28, the test results for the above-mentioned compounds, reflect an equivalent activity between the above analog compounds and the naturally occurring compounds.
During the testimony period of this interference, Dr. James Weeks, another Upjohn research scientist, was questioned about the reliability of the BP test. He answered that, as of April 1971, this test had been in use for between five and six years. In that period, he said it gave excellent results.
The GC-SMS test was in vitro as opposed to the in vivo BP test. Purportedly, Upjohn technicians excised a section of colon from a freshly-killed gerbil for suspension in a physiological solution. A lever arm was connected to the colon in such a way that any contraction was recorded as a polygraph trace. For comparison purposes, PGE, a known smooth muscle stimulant, was employed. Both of Nelson's tested analog compounds were said to closely approximate the response of the natural compounds.
Both conception and preparation by Nelson of compounds within the scope of counts 1, 2, and 4 were held to have occurred prior to the critical date. Since the counts did not recite any utility, the board declared that the 16-phenoxy PG's, could have any practical utility, i. e., utility sufficient for an actual reduction to practice, citing Blicke v. Treves, 44 CCPA 753, 241 F.2d 718, 112 USPQ 472 (1957). But priority was not awarded to Nelson because his evidence was held not to show adequate proof of practical utility.
The tests used by Nelson were characterized as "rough screens, uncorrelated with actual utility." The board said neither the biphasic pressor effect in rats nor the stimulation of gerbil colon smooth muscle revealed a practical utility, citing Rey-Bellet v. Engelhardt, 493 F.2d 1380, 181 USPQ 453 (Cust. & Pat.App.1974). The present situation was compared to that in Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688 (Cust. & Pat.App.1973), where only a potential utility was established.
Finally, Nelson's conduct, as evidenced by statements in his application, was evaluated for inequitable conduct which might establish fraud. The clear and convincing proof necessary to establish fraud was held to be missing. The board stated that Bowler failed to show how Nelson had either misled the examiner or knowingly presented false information. Speculative statements of utility were found insufficient to establish inequitable conduct.
OPINIONThe board correctly stated that evidence of any utility is sufficient since the counts do not recite any particular utility. Blicke v. Treves, supra. However, we cannot agree with its conclusion that the pharmacological activity evidenced by the BP and the GC-SMS tests does not establish a practical utility. Even though Nelson now admits that antifertility activity such as luteolysis is not proven by these tests, the board erred in not recognizing that tests evidencing pharmacological activity may manifest a practical utility even though they may not establish a specific therapeutic use.
"Practical utility" is a shorthand way of attributing "real-world" value to claimed subject matter. In other words, one skilled in the art can use a claimed discovery in a manner which provides some immediate benefit to the public.
Knowledge of the pharmacological activity of any compound is obviously beneficial to the public. It is inherently faster and easier to combat illnesses and alleviate symptoms when the medical profession is armed with an arsenal of chemicals having known pharmacological activities. Since it is crucial to provide researchers with an incentive to disclose pharmacological activities in as many compounds as possible, we conclude that adequate proof of any such activity constitutes a showing of practical utility.
Bowler argues that the BP and GC-SMS tests are inconclusive showings of pharmacological activity since confirmation by statistically significant means, i.e., a 4-point assay,4 occurred after the critical date. But a rigorous correlation is not necessary where the test for pharmacological activity is reasonably indicative of the desired response. While Dr. Brown, an Upjohn PG researcher, testified that treatment of one muscle with various successive compounds, as done here, could involve a small residual carryover effect from one compound to another, he also indicated that the correlation between the "preliminary" test and 4-point assays was reasonably certain. In view of the above correlation, the 4-point assay, while preferable, was not the sole means for establishing practical utility.
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