Eli Lilly & Co., In re, 89-1076
| Decision Date | 30 April 1990 |
| Docket Number | No. 89-1076,89-1076 |
| Parties | IN re ELI LILLY & COMPANY. |
| Court | U.S. Court of Appeals — Federal Circuit |
Donald R. Dunner, Finnegan, Henderson, Farabow, Garrett & Dunner, Washington D.C., argued for appellant. With him on the brief was Herbert H. Mintz. Also on the brief were Leroy Whitaker and Joseph A. Jones, Eli Lilly & Co., Indianapolis, Ind., of counsel.
John H. Raubitschek, Associate Sol., Office of the Sol., Arlington, Va., argued for appellee. With him on the brief was Fred E. McKelvey, Sol.
William H. Epstein, Hoffmann-La Roche Inc., Nutley, N.J., argued for intervenor, Hoffmann-La Roche Inc. With him on the brief were Christopher K. Hu and Patricia S. Rocha. Also on the brief was John C. Vassil, Morgan & Finnegan, New York City.
Before NEWMAN and MICHEL, Circuit Judges, and NICHOLS, Senior Circuit Judge. *
The decision of the United States Patent and Trademark Office Board of Patent Appeals and Interferences (the "Board"), rejecting claims 1-7, all of the claims on reexamination of United States Patent No. 3,794,732, inventor Arthur P. Raun, assignee Eli Lilly & Company (hereinafter "Lilly"), is affirmed.
The Raun claims are directed to the method of using the chemical compound identified as X537A (common name "lasalocid") to enhance feed conversion efficiency in mature ruminant animals such as cattle and sheep.
Claim 1 of the Raun patent is illustrative:
1. A method of increasing the efficiency of feed utilization of ruminant animals having a developed rumen function which comprises the oral administration to such animals of a propionate-increasing amount of an antibiotic chosen from the group consisting of X537A and its physiologically acceptable esters and salts.
The Board held the claims unpatentable in terms of 35 U.S.C. Sec. 103, in view of certain Berger United States and foreign patents. All the Berger references discuss control of coccidiosis in fowl by treatment with X537A, and the weight gain effect of this treatment, as follows:
The active ingredient when orally administered to coccidiosis susceptible domestic fowl, particularly turkeys and chickens, as a component of feed, effectively controls the disease by either preventing it or curing it after it occurs. Furthermore, the treated fowl either maintain their weight or actually gain weight when compared to controls. Thus, the compositions of this invention not only control coccidiosis, but also, aid in improving the efficiency of conversion of feed to weight gains.
Berger U.S. Patent No. 3,719,753, column 5, lines 3-11. Berger's Southern Rhodesian patent No. 350/68/372 (June 30, 1962) includes the following disclosure, appearing as claim 23 of that patent:
A composition aiding in improving the efficiency of conversion of feed to weight gains in animals raised commercially for food purposes comprising ... antibiotic X-537A and pharmaceutically acceptable salts thereof.
The Southern Rhodesian patent describes (in claims 24-25) the dosages of X537A in these compositions, and also discloses (as the text of claims 26-29) an "animal feed composition" containing X537A "for aiding in improving the efficiency of conversion of feed to weight gains". The Berger references state that animals raised commercially for food purposes and subject to coccidiosis are "poultry ..., sheep, cattle, swine, etc."
The Berger data show an average weight gain of Eimeria tanella (coccidiosis) infected chickens treated with X537A that was greater than the weight gain of untreated infected chickens, Berger stating "[i]t should also be noted from the data in the table that the use of antibiotic as a coccidiostat does not substantially adversely affect the conversion of feed to weight gain" in the infected chickens. In the example for multiple Eimeria infections the average weight gain of treated infected chickens was shown as 108% and 105%, compared with untreated uninfected controls at 100%. Id. at columns 9-10. Berger described the weight gain effect in chickens as "greater than expected":
[T]he antibiotic is ... further significant in causing greater than expected efficiency of conversion of feed to weight gain in the chickens[.]
Id. at column 10, lines 64-67. Berger does not present experimental data for any animal other than chickens.
In response to the examiner's rejection of the claims based on the Berger references, Lilly argued that Raun had shown certain unexpected results pertinent to weight gain in ruminant animals, and presented evidence and argument in support of patentability. The Board held, on the entire record, that the invention of the Raun claims would have been obvious in terms of Section 103.
The Board held that a prima facie case of obviousness was made by the Berger references. We agree, for the references show the same compound, X537A, as having the same general property of enhancing weight gain in animals. The burden thus was upon Lilly to come forward with evidence of the unobviousness of its claimed invention of the use of X537A to enhance weight gain in mature ruminant animals. After a prima facie case of obviousness has been made and rebuttal evidence submitted, all the evidence must be considered anew. In re Piasecki, 745 F.2d 1468, 1472, 223 USPQ 785, 788 (Fed.Cir.1984):
When prima facie obviousness is established and evidence is submitted in rebuttal, the decision-maker must start over.... An earlier decision should not, as it was here, be considered as set in concrete, and applicant's rebuttal evidence then be evaluated only on its knockdown ability.... Facts established by rebuttal evidence must be evaluated along with the facts on which the earlier conclusion was reached, not against the conclusion itself.
(quoting In re Rinehart, 531 F.2d 1048, 1052, 189 USPQ 143, 147 (CCPA 1976)).
Lilly provided expert opinions, documentary evidence and experimental data. Intervenor Hoffmann-La Roche ("Roche"), the assignee of the Berger United States patent, provided contrary analysis and argument.
Lilly argues that the most reasonable reading of the Berger references, including the Berger foreign patents, is as showing the use of X537A for treatment or prophylaxis of coccidiosis-infected chickens, and that it is unwarranted to read Berger's broad statements as teaching or suggesting the enhanced efficiency of weight gain in such animals as cattle and sheep. Lilly stresses that Berger does not provide data on the effects of feeding X537A to any animal except chickens, and does not state that X537A should be fed to healthy cattle, or even to healthy chickens, in order to enhance their feed to weight gain efficiency. Lilly argues that at most Berger offers an invitation to experiment; that is, that the Berger teachings are in the discredited "obvious-to-try" category of disclosure insofar as they affect the Raun claimed invention.
An "obvious-to-try" situation exists when a general disclosure may pique the scientist's curiosity, such that further investigation might be done as a result of the disclosure, but the disclosure itself does not contain a sufficient teaching of how to obtain the desired result, or that the claimed result would be obtained if certain directions were pursued. See generally In re O'Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed.Cir.1988) ().
Lilly presented the opinions of two persons, experienced in the field of animal husbandry, who stated that they viewed the Berger references as showing that the use of X537A to treat coccidiosis-infected chickens simply relieved the stress of the disease, thereby improving weight gain in chickens. One of these persons stated that because of the different digestive metabolisms of ruminants, as compared with chickens, the weight gain shown by Berger for chickens would not have led him to expect that X537A would be effective for weight gain purposes with cattle and sheep. Lilly presented experimental data that mature cattle (having a developed rumen function) experienced a higher percentage weight gain due to X537A, as compared with immature (unweaned, rumen function undeveloped) calves. Lilly argues that this result was unexpected, and overcomes any prima facie case of obviousness.
These arguments are countered by intervenor Roche. Roche stresses that the Berger foreign references describe X537A compositions for improving weight gain in animals grown commercially for food ("poultry ..., cattle, sheep, swine, etc."), and that the Southern Rhodesian patent disclosure is not limited to coccidiosis-infected animals or to chickens. Roche points to references showing compounds that improve weight gain in both poultry and cattle as evidence supporting obviousness of the Raun claimed invention.
Roche also challenges the significance of Lilly's data comparing the weight gains of calves and cattle, Roche arguing that Lilly's unweaned calves, even without treatment with X537A, were such highly efficient utilizers of their liquid feed that Lilly's comparisons are not probative of unexpected results with cattle. The data are shown in the following chart, accompanied by Lilly's interpretation thereof and Roche's counter-analysis.
Calves Steers
Control X537A Control X537A
A. Av. daily intake (lbs) 3.04 3.05 16.76 15.77
B. Av. daily gain (lbs) 2.38 2.44 3.18 3.47
Lilly's Analysis
Intake/Gain (A/B ratio) 1.28 1.25 5.28 4.55
% Improvement over Control -- 2.3% -- 13.8%
Roche's Analysis
Gain/Intake (B/A %) 78.3% 80.0% 19.0% 22.0%
Improvement over Control -- 1.7% -- 3.0%
% of Maximum Improvement --
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