Cross v. Iizuka, 84-1111
| Decision Date | 28 January 1985 |
| Docket Number | No. 84-1111,No. 100,650,84-1111,100,650 |
| Citation | 753 F.2d 1040,224 USPQ 739 |
| Parties | Peter E. CROSS, et al., Appellants, v. Kinji IIZUKA, et al., Appellees. AppealInterference |
| Court | U.S. Court of Appeals — Federal Circuit |
Rudolf E. Hutz, Connolly, Bove, Lodge & Hutz, Wilmington, Del., argued for appellants. With him on the brief was Thomas M. Meshbesher, Wilmington, Del.
Peter D. Olexy, Sughrue, Mion, Zinn, MacPeak & Seas, Washington, D.C., argued for appellees. With him on the brief was Thomas J. MacPeak, Washington, D.C.
Before KASHIWA, BENNETT and BISSELL, Circuit Judges.
This appeal is from the decision of the United States Patent and Trademark Office (PTO) Board of Patent Interferences (Board) awarding priority on the single phantom count to Iizuka, et al. (Iizuka), the senior party. We affirm.
wherein R is a hydrogen atom or an alkyl group having 1 to 6 carbon atoms, each of A1 or A2 , which may be the same or different, are alkylene having 1 to 8 carbon atoms, m is 0 or 1, X is oxygen or sulfur, and each of R1 or R2 , which may be the same or different, is a hydrogen atom or an alkyl group having 1 to 6 carbon atoms; R3 is H, C1 -C4 alkyl, C1 -C4 alkoxy or halogen; and the pharmaceutically acceptable salts thereof. 1
The applications of Cross and Iizuka both disclose inventions directed to imidazole derivative compounds which inhibit the synthesis of thromboxane synthetase, an enzyme which leads to the formation of thromboxane A2 (TXA2 ), 2 a highly unstable, biologically active compound which is converted to stable thromboxane B2 by the addition of water. Thromboxane A2 , as of the time period during which the applications were filed, was postulated to be a causal factor in platelet aggregation. 3 Platelet aggregation is associated with several deleterious conditions in mammalia, including humans, such as platelet thrombosis, pulmonary vasoconstriction or vasospasm, inflammation, hypertension, and collagen-induced thrombosis.
Pursuant to 37 C.F.R. Sec. 1.231(a)(4) each party moved to be accorded the benefit of a foreign priority application under 35 U.S.C. Sec. 119, Cross claiming priority based upon a British application filed 13 December 1978, and Iizuka claiming priority based upon a Japanese application filed 21 August 1978. Each party opposed the motion of the other party, each party contending that the other party's foreign priority application did not comply with the disclosure requirements of 35 U.S.C. Sec. 112.
The primary examiner granted each party's motion, noting that the utility alleged in each application was of a pharmacological nature, i.e., the inhibition of thromboxane synthetase, and that inasmuch as the single phantom count of the interference was directed to a compound, it was not necessary that utility be established by tests and dosages with respect to human beings. The examiner found that one of ordinary skill in the art would know how to use the imidazole derivatives, i.e., be able to determine specific dosages, for biological purposes. Based upon the filing dates of Cross requested a final hearing on the issue of the sufficiency of the Japanese priority application of Iizuka, and moved for a testimony period to present evidence on this issue. A testimony period was granted over the opposition of Iizuka, and Cross took the testimony of his expert witness, Dr. Smith, and Iizuka took the testimony of his expert witness, Dr. Ramwell and also proferred several exhibits pursuant to 37 C.F.R. Sec. 1.282. All testimony and exhibits related to the sufficiency of Iizuka's Japanese priority application, i.e., whether it complied with the disclosure requirements of 35 U.S.C. Sec. 112.
the foreign priority applications, 4 Iizuka was declared the senior party and a show cause order was issued against Cross.
The Board noted that the sole issue before it was whether Iizuka was entitled to the benefit of his Japanese priority application. 5 Relying on In re Bundy, 642 F.2d 430, 209 USPQ 48 (CCPA 1981), and Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980), the Board held that tests evidencing pharmacological activity may manifest a practical utility even though they may not establish a specific therapeutic use. The Board found that the Japanese priority application disclosed pharmacological activity in the similar activity of the imidazole derivatives of the count to imidazole and 1-methylimidazole, which possess an inhibitory action for thromboxane synthetase, and that practical utility was disclosed in the strong inhibitory action for thromboxane synthetase from human or bovine platelet microsomes, i.e., an in vitro utility. 6
The Board further found that the Japanese priority application disclosed "how-to-use" knowledge directed to the practical utility in a microsome system, and that microsome assays were admittedly known in the art. A skilled worker could determine the relative strength of the imidazole compounds of the count vis-a-vis the known parent imidazole and 1-methylimidazole compounds for use in the microsome assay milieu. Knowledge of the pharmacological activities of compounds is beneficial to the medical profession, and requiring Iizuka to have disclosed in vivo dosages in the Japanese priority application would delay and frustrate researchers by failing to provide an incentive for early public disclosure of such compounds, thereby failing to further the public interest.
Accordingly, the Board held that the Japanese priority application contained an adequate how-to-use disclosure for the practical utility stated therein.
Whether the Board erred in finding that the utility disclosed in the Japanese priority application is sufficient to meet the practical utility requirement of 35 U.S.C. Sec. 101.
Whether the Board erred in finding that the Japanese priority application contained sufficient disclosure to satisfy the enablement, i.e., how-to-use, requirement of 35 U.S.C. Sec. 112. 7
OPINIONProper resolution of the issues before this court necessitates that we address, seriatim, the following questions: (1) What utility is disclosed by the Japanese priority application? (2) Does this stated utility comply with the "practical utility" requirement of 35 U.S.C. Sec. 101, as delimited by prior decisions of the judiciary? 8 (3) Does the Japanese priority application contain sufficient disclosure to meet the how-to-use requirement of Sec. 112 with respect to the stated utility?
It is axiomatic that an invention cannot be considered "useful", in the sense that a patent can be granted on it, unless substantial or practical utility for the invention has been discovered and disclosed where such utility would not be obvious. Brenner v. Manson, 383 U.S. 519, 86 S.Ct. 1033, 16 L.Ed.2d 69, 148 USPQ 689 (1966). Where a constructive reduction to practice is involved, as contrasted to an actual reduction to practice, a practical utility for the invention is determined by reference to, and a factual analysis of, the disclosures of the application. Kawai v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973).
The Board factually analyzed the Japanese priority application and found that the only effective disclosure relating to a stated utility for the imidazole derivative compounds of the phantom count was the following:
[The compounds disclosed] are useful for treatment of inflammation, thrombus, hypertension, cerebral apoplexy, asthma, etc.
Up to this time, it is a known fact that imidazole and 1-methylimidazole possess an inhibitory action for thromboxane synthetase and inhibit a biosynthesis of thromboxane A2 . (Prostaglandins, Vol. 13, pages 611-, 1977 ). However, since their inhibitory effect is not satisfactory one, these compounds have not been put to practical use yet as therapeutical medicines for diseases caused by thromboxane A2 , such as inflammation, hypertension, thrombus, cerebral apoplexy, asthma, etc.
To develop some compounds possessing a strong inhibitory action for biosynthesis of thromboxane A2 , the present inventors devoted themselves to study for various imidazole derivatives, and as a result, found that the compounds [of this invention] possess a strong inhibitory action for thromboxane synthetase from human or bovine platelet microsomes and are extremely useful as therapeutically active agents for diseases caused by thromboxane A2 , for example, inflammation, hypertension, thrombus, cerebral apoplexy, asthma, etc., and thus we proposed this invention based upon those findings.
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The imidazole derivatives ... of this invention are novel compounds which are not described in literature, and which possess a strong inhibitory action for thromboxane synthetase from human or bovine platelet microsomes, and which exhibit a strong inhibitory action for biosynthesis of thromboxane A2 in mammalia including human. In general, a satisfactory inhibitory effect is found at a level of molar concentrations of 2.5 X 10 -8, for example, 2-[p-(1-imidazolylmethyl) phenoxy]-acetic acid hydrochloride produce the about 50% inhibitory effect at the molar concentrations of 2.5 X 10 -8. Accordingly, the imidazole derivatives of this invention are extremely useful as therapeutical medicines for diseases caused by...
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