Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE MARCO QUADRANTI AND WILLY MAURER
Appeal No. 91-1912
May 22, 1992
Application for Patent filed November 18, 1988, Serial No. 272,849. Synergistic Composition and Method for the Selective Control of Weeds.
Kevin T. Mansfield et al. for appellants
Primary Examiner--Glennon H. Hollrah
This appeal is from the examiner's final rejection of claims 3, 14, 15, 21 and 22, which are all of the claims remaining in the application. A copy of illustrative claim 22 is appended to this opinion.
References relied on by the examiner on appeal are:
Meyer et al. (Meyer) 4,478,635 Oct. 23, 1984
Worthing et al. (Worthing) (Editor), The Pesticide Manual, 8th Ed., The British Crop Protection Council, pp. 36-37, 198-199, 778-779, 568-569, 5-6, 479-482, 100-102, 94, 189-190, 251-252, 731, 63-64, 220-222, 522-523, 267- 268 (no date provided).
All of the appealed claims have been finally rejected under 35 U.S.C. 103 as being unpatentable over Meyer in view of The Pesticide Manual. We shall affirm this rejection.
It does not appear that appellants have controverted the issue of prima facie obviousness. If they did, we would of necessity agree with the examiner's position on this issue. It is generally true that the use of materials in combination each of which is known to function for the intended purpose is prima facie obvious. In re Kerkhoven, 626 F.2d 846, 205 USPQ 1069 (CCPA 1980); In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960). With regard to the subject matter of the present claims, the use of combinations of herbicides is so notoriously well known as to be capable of being taken by official notice.
The salient issue on this appeal is whether or not appellants have established unobvious results adequate to amount to evidence sufficient to outweigh the evidence of obviousness of record. We agree with the examiner's general conclusion that they have not. However, since we do not agree with the examiner's reasoning in every particular and since we feel compelled to make some comments concerning the scientific validity of appellants' analysis of synergistic results, we shall add the following comments.
On the issue of whether or not synergism has been demonstrated, generalizations such as the Colby formula are not particularly useful. The Colby equation inherently results in an expectation of a less than additive effect for any combination of herbicides. There is no evidence of record that this approach is considered to be valid by a significant number of ordinarily skilled workers or authorities in this area of technology. It could reasonably be argued that at least additive results should be expected, and an argument can even be made out for the proposition that in most cases better than additive results could be expected. The examiner has indicated certain clear anomalies that the Colby equation gives rise to. We would, however, mention several additional reasons for expecting better than additive results with the use of two or more, different herbicides.
*2 If two or more herbicides functioned by somewhat different biological mechanisms, their combined use could clearly be expected to be more efficient than the use of merely a larger amount of any one of the individual herbicides since multiple biological pathways would be affected at the same time. It is also known that, in any population of plants as with any organisms, some will be more resistant to a particular biocide than others. The statistical probability of a large number of plants having higher than usual resistance to all of the components of any particular combination of herbicides, however, is not great.
The point on which we differ from the examiner's position in his insistence that there is only one appropriate two pronged test to establish synergism. We do not find this generalization to be any more useful than the Colby formula test. There are undoubtedly many appropriate methods of demonstrating synergism. In each case, however, the facts shown must be analyzed to determine whether the method chosen in that case has in fact clearly and convincingly demonstrated the existence of synergism or, more generally speaking, an unobvious result. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979).
It is not clear whether or not appellants agree with the examiner's statement that the only relevant data is in the table at page 22 of the specification. We do agree with that position. The examiner required appellants to elect a single disclosed species for prosecution on the merits, and examination of the claims has been limited to the elected species, [FN1] alachlor. Thus, it is appropriate for us to limit our consideration to the asserted evidence of unobvious results relating only to the elected species. See Ex parte Ohsaka, 2 USPQ2d 1461 (BPAI 1987).
The data at page 22 of the specification illustrate that the addition of various ineffective amounts of Compound IIIb to a slightly effective amount of Compound I produced mixtures having somewhat greater effectiveness than Compound I alone. The absolute effectiveness of all of the mixtures tested, with a single exception, was not very great. For the following reasons, we find that this evidence is inadequate to outweigh the clear evidence of record of obviousness of the claimed subject matter, i.e., it does not clearly and convincingly rebut the prima facie case of obviousness which the examiner has made out.
Assuming arguendo that the differences in values presented are statistically significant, there is no evidence that they represent a true, practical advantage. In re Freeman, 474 F.2d 1318, 177 USPQ 139 (CCPA 1973); In re Klosak, 455 F.2d 1077, 173 USPQ 14 (CCPA 1972); In re D'Ancicco, 439 F.2d 1244, 169 USPQ 303 (CCPA 1971). Also, prescinding from the Colby formula test, which as we have already indicated is at best controversial and in our view probably invalid, there is no evidence that the differences are unexpected. In re Merck, 800 F.2d 1091, 231 USPQ 375 (Fed.Cir.1986); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed.Cir.1985); In re Freeman, supra.
*3 Immediately above, we assumed arguendo that the results presented were statistically significant. There is in fact no basis for actually making such an assumption, however. No measure of statistical significance in terms either of P values or confidence limits has been presented. This is particularly important where the differences in question are fairly small, as they are here. The irregular nature of the increase in effectiveness as doubled amounts of Compound IIIb are added also gives rise to questions concerning the reproduceability of the tests used and, thus, the significance of the results. Although patent application specifications are generally not held to the same high standard as scholarly scientific publications, in which statistical significance measures are presented routinely almost as a sine qua non, where as here, the data in question are relied on as evidence of unobviousness as it effects the ultimate issue under 35 U.S.C. 103, statistical analysis would unquestionably enhance the probative value of that evidence.
For the reasons stated by the examiner in the answer on appeal as emphasized and amplified herein, the rejection of all of the claims is affirmed.
No time period for taking any subsequent action in connection with this appeal may be extended under 37 CFR 1.136(a). See the final rule notice, 54 F.R. 29548 (July 13, 1989), 1105 O.G. 5 (August 1, 1989).
BOARD OF PATENT APPEALS AND INTERFERENCES
James A. Seidleck
William F. Smith
FN1. Although it appears that Formula III is intended to comprehend only two compounds, metolachlor (Compound IIIa) and alachlor (Compound IIIb), it actually embraces four compounds.
together with synergistically effective amount of 3 to 50 parts by weight of a further active ingredient of formula III
wherin R2 is methyl or ethyl and R3 is methoxymethyl or 2-methoxy-1-methylethyl and, if desired, a carrier of other adjuvant.