Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE A
Appeal No. 89-2432
June 5, 1990
Heard: May 22, 1990
Application for Patent filed February 28, 1986, Serial No. 834,577. Quinolonecarboxylic Acid Derivative and Process for Its Preparation.
Richard D. Kelly et al. for appellants
Supervisory Primary Examiner--Donald G. Daus
Before Goldstein, Metz and Wiseman
This appeal was originally taken from the examiner's final rejection of claims 1, 3 and 4. Subsequently claim 4 was cancelled. Although, at the beginning of appellants' appeal brief, it is stated that this appeal is "from the final rejection of all claims pending in this application," claim 3 was not reproduced in the brief on appeal. The examiner assumed that this omission was inadvertent but, by implication from the fact that claim 3 has not been argued separately in the brief, and from statements made upon oral hearing of this appeal, it appears likely that the rejection of claim 3 was not intended to be appealed. Nonetheless, in the event that we are mistaken in drawing this inference, we shall treat claim 3 as being on appeal. Because, as we have already indicated, no separate arguments have been presented, claim 3 may be considered to stand or fall with claim 1. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed.Cir.1986); In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). Even so, for the sake of completeness, we shall address specific remarks to the patentability of claim 3 in this decision.
References relied on by the examiner on appeal are:
Culbertson et al. (Culbertson) 4,638,067 Jan. 20, 1987
Petersen et al. (Petersen) 167,763 Jan. 15, 1986
(European patent specification)
Irikura 2,057,440 Apr. 01, 1981
Claims 1 and 3 have been finally rejected under 35 USC 102(a) as being anticipated by Peterson. We shall affirm this rejection.
All page references in the following discussion shall be to the English language translation of record (apparently supplied by appellants) of the European patent specification, which was originally published in German.
The examiner has adequately explained the basis of the conclusion that the reference anticipates the appealed claims and sufficiently convincingly rebutted all of appellants' arguments that we could simply adopt the examiner's position as our own, adding no further comment. However, since appellants have expressly invited us to decide what they consider to be "a significant policy question," [FN1] we feel constrained to present additional comments, both to emphasize those aspects of the examiner's position with which we agree and for the sake of completeness.
*2 Appellants have acknowledged (at least implicitly on the written record and expressly upon oral hearing) that the synthetic procedures disclosed in the reference enable the preparation of the compound, which is explicitly disclosed at page 13 of the reference. It has not been controverted that the name of the compound disclosed corresponds to the formula presented in appellants' claim 1. Thus, even if there were no disclosure of utility in the reference, the examiner would have been correct in holding that the claim was anticipated, and the examiner's citation of In re Hafner, 56 CCPA 1424, 410 F.2d 1403, 161 USPQ 783 (1969) would have been quite appropriate. Since the reference does disclose a specific utility for the compound (generally the same utility as in the present case), this issue does not arise (but see the discussion of Claim 3, below).
We find only twenty-two compounds in the list presented at pages 12 to 14, disclosed in addition to those listed in the working examples, and not twenty-three as found by the examiner. There are twenty-four compounds disclosed in the working examples. In either event, forty-six or forty-seven compounds hardly amounts to the "list of thousands" referred to in In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973), relied on by appellants. Furthermore, as the examiner has correctly pointed out, the critical issue in Wiggins was whether or not the name of a compound was a description of that compound in the absence of a known synthetic method of producing that compound. That issue does not arise on the present facts.
Even if the number of compounds disclosed in the reference were several orders of magnitude greater, we would come to the same conclusion. The tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is "described," as that term is used in 35 USC 102(a), in that publication. A similar conclusion would be appropriate with respect to the approximately 1.5 million compounds disclosed in the Beilstein Handbook (Handbuch der Organischen Chemie). As a general principle it has long been held, even where the issue was one of obviousness and not clear anticipation or description, that the comprehensiveness of a reference disclosure does not derogate from its teaching effect. Merck Co. v. Biocraft Laboratories, Inc., __ F.2d __, 10 USPQ2d 1843 (Fed.Cir.1989); In re Corkill, 771 F.2d 1496, 226 USPQ 105 (Fed.Cir.1985). In re Susi, 58 CCPA 1074, 440 F.2d 442, 169 USPQ 423 (1971); In re Lemin, 51 CCPA 1404, 332 F.2d 839, 141 USPQ 814 (CCPA 1964); In re Rosicky, 276 F.2d 656, 125 USPQ 341 (CCPA 1960).
*3 With regard to the numerous other precedents discussed by appellants, they invariably deal with a significantly different set of facts. In each case, to arrive at the claimed subject matter, it was necessary to select portions of that subject matter from various sections of the reference disclosure and combine them [FN2], e.g., selecting values for variable substituents to interpolate into a generic structural formula to arrive at a specific compound. Even in those cases, if the classes were sufficiently limited or well delineated, anticipation was found. Compare In re Arkley, 455 F.2d 586, 172 USPQ 524 (CCPA 1972), with In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982); In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978); In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962).
Of course, it goes without saying (but, equally of course, we are going to say it) that the evidence of asserted unobvious results of record is not relevant to this rejection. In re Malagari, 499 F.2d 1297, 182 USPQ 549 (CCPA 1974).
Claim 3, which recites "an antibacterial pharmaceutical composition" broadly, may or may not be intended to be on appeal, as we have discussed above, and no separate arguments have been drawn to this claim. Nonetheless, we shall indicate our reasons for considering the above comments to apply to essentially the same degree to the rejection of claim 3, for the sake of completeness of this record, in the event, for example, that further appeal should be taken from this decision.
As we have stated above, there are only forty-six (or forty-seven) compounds described specifically in the reference. The compounds are disclosed as having "antibacterial activity" and being "meant for use as active compounds in medicaments" (see Item 57 on the title page). Various types of specific pharmaceutical compositions utilizing various acceptable carriers are expressly disclosed at pages 28 to 30. The nature of this disclosure is such that we are convinced that this reference should appropriately be considered to "describe," in the sense of 35 USC 102, pharmaceutical compositions containing each of the forty-six (or forty-seven) specific, pharmaceutically active compounds disclosed. Again, compare Arkley with Sivaramakrishnan, Schaumann and Petering.
Claims 1 and 3 have been finally rejected under 35 USC 103 as being unpatentable over Culbertson in view of Irikura. We shall not affirm this rejection.
On the issue of prima facie obviousness, we would have found the examiner's conclusion to be supported by the disclosure of Culbertson alone. That disclosure is generic to the here claimed subject matter, and the species of Example 45 differs from appellants' claimed compound only in having an 8-fluoro substituent in place of an substituent.
*4 With regard to this rejection under 35 USC 103, appellants evidence of asserted unobvious results is relevant. We have considered that evidence, specifically the declaration of Irikura, under 37 CFR 1.132, and we disagree with the examiner's conclusion. It is the examiner's position that, to rebut the evidence of obviousness, it is necessary for the claimed compound to be unexpectedly different from the reference compounds "overall," i.e., in its therapeutic effect against all bacteria. However, appellants' thesis is that their compound is unexpectedly and significantly superior against anaerobic bacteria, a property which makes it unexpectedly suited for a specific, important utility. Conceptually, this can be the basis for overcoming a prima facie case of obviousness. In re Chupp, 816 F.2d 643, 2 USPQ2d 1437 (Fed.Cir.1986); In re Murch, 464 F.2d 1051, 175 USPQ 89 (CCPA 1972). The issue in each case is the weight of the actual evidence of unobviousness presented, balanced against the weight of obviousness of record.
In the declaration (page 2, first complete paragraph), it is indicated that a difference in minimum inhibitory concentration of a factor of two is considered to be "activity ... on the same level." Even when this consideration is taken into account, however, appellants' claimed compound is significantly more active [FN3] against the first seven species of anaerobic bacteria listed in Table 1-b. Furthermore, Figures 1a and 1b illustrate that appellants' compound, when administered in the same dosage, provides substantially higher serum levels, for at least two hours at low doses and a substantially longer period of time at higher doses. In the absence of any explanation to support a holding to the contrary, we accept the conclusion at page 11 of the declaration that the evidence indicates "superiority" and that the "superiority was unexpected." In view of the precedents cited above, we find this evidence of unexpected superiority adequate to outweigh the evidence of obviousness found in the references adduced by the examiner.
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
Andrew H. Metz
Thomas G. Wiseman
FN1. The "policy question" appears to be whether or not the Patent and Trademark Office shall continue to interpret 35 USC 102(a) literally.
FN2. Somewhat reminiscent of the lexicographer who described his dictionary as "a poem about everything," but clearly not the case here.