IN RE BRANA
51 F.3d 1560 (1995)
In re Miguel F. BRANA, Jose M.C. Berlanga, Marina M. Moset, Erich Schlick and Gerhard Keilhauer.
United States Court of Appeals, Federal Circuit.
March 30, 1995.
Malcolm J. MacDonald, Keil & MacDonald, Washington, DC, argued, for appellant. With him on the brief was Herbert B. Keil. Of counsel was David S. Nagy.
Fred E. McKelvey, Sol., Office of Sol., Arlington, VA, argued, for appellee. With him on the brief were Albin F. Drost, Deputy Sol., Richard E. Schafer, Teddy S. Gron, Joseph G. Piccolo and Richard L. Torczon, Associate Sols.
Before PLAGER, LOURIE, and RADER, Circuit Judges.
PLAGER, Circuit Judge.
Miguel F. Brana, et al. (applicants), appeal the March 19, 1993 decision of the United States Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (Board), in Appeal No. 92-1196. The Board affirmed the examiner's rejection of claims 10-13 of patent application Serial No. 533,944 under 35 U.S.C. § 112 ¶ 1 (1988).1 The examiner's rejection, upon which the Board relied in rendering its decision, was based specifically on a challenge to the utility of the claimed compounds and the amount of experimentation necessary to use the compounds. We conclude the Board erred, and reverse.I. BACKGROUND On June 30, 1988, applicants filed patent application Serial No. 213,690 (the '690 application)2 directed to 5-nitrobenzo[de]isoquinoline-1,3-dione compounds, for use as antitumor substances, having the following formula:
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where n is 1 or 2, R1 and R2 are identical or different and are each hydrogen, C1-C6-alkyl, C1-C6-hydroxyalkyl, pyrrolidinyl, morpholino, piperidinyl or piperacinyl, and R3 and R4 are identical or different and are each hydrogen, C1-C6-alkyl, C1-C6-acyl, C2-C7-alkoxycarbonyl, ureyl, aminocarbonyl or C2-C7-alkylaminocarbonyl. These claimed compounds differ from several prior art benzo[de]isoquinoline-1,3-dione compounds due to the presence of a nitro group (O2N) at the 5-position and an amino or other amino group (NR3R4) at the 8-position of the isoquinoline ring.
The specification states that these non-symmetrical substitutions at the 5- and 8- positions produce compounds with "a better action and a better action spectrum as antitumor substances" than known benzo[de]isoquinolines, namely those in K.D. Paull et al., Computer Assisted Structure-Activity Correlations, Drug Research, 34(II), 1243-46 (1984) (Paull). Paull describes a computer-assisted evaluation of benzo[de]isoquinoline-1,3-diones and related compounds which have been screened for antitumor activity by testing their efficacy in vivo3 against two specific implanted murine (i.e., utilizing mice as test subjects) lymphocytic leukemias, P388 and L1210.4 These two in vivo tests are
widely used by the National Cancer Institute (NCI) to measure the antitumor properties of a compound. Paull noted that one compound in particular, benzo[de]isoquinoline-1,3(2H)dione,5-amino-2(2-dimethyl-aminoe-thyl [sic]) (hereinafter "NSC 308847"), was found to show excellent activity against these two specific tumor models. Based on their analysis, compound NSC 308847 was selected for further studies by NCL. In addition to comparing the effectiveness of the claimed compounds with structurally similar compounds in Paull, applicants' patent specification illustrates the cytotoxicity of the claimed compounds against human tumor cells, in vitro,5 and concludes that these tests "had a good action."6