51 F.3d 1560 (Fed. Cir. 1995), 93-1393, In re Brana
|Citation:||51 F.3d 1560|
|Party Name:||34 U.S.P.Q.2d 1436 In re Miguel F. BRANA, Jose M.C. Berlanga, Marina M. Moset, Erich Schlick and Gerhard Keilhauer.|
|Case Date:||March 30, 1995|
|Court:||United States Courts of Appeals, Court of Appeals for the Federal Circuit|
[Copyrighted Material Omitted]
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. Sec. 112 p 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.
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:
NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE
where n is 1 or 2, R 1 and R 2 are identical or different and are each hydrogen, C sub1 -C sub6 -alkyl, C sub1 -C sub6 -hydroxyalkyl, pyrrolidinyl, morpholino, piperidinyl or piperacinyl, and R 3 and R 4 are identical or different and are each hydrogen, C sub1 -C sub6 -alkyl, C sub1 -C sub6 -acyl, C sub2 -C sub7 -alkoxycarbonyl, ureyl, aminocarbonyl or C sub2 -C sub7 -alkylaminocarbonyl. These claimed compounds differ from several prior art benzo[de]isoquinoline-1,3-dione compounds due to the presence of a nitro group (O sub2 N) at the 5-position and an amino or other amino group (NR 3R 4) 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 vivo 3 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-aminoethyl [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 NCI. 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
The examiner initially rejected applicants' claims in the '690 application as obvious under 35 U.S.C. Sec. 103 in light of U.S. Patent No. 4,614,820, issued to and referred to hereafter as Zee-Cheng et al. Zee-Cheng et al. discloses a benzo[de]isoquinoline compound for use as an antitumor agent with symmetrical substitutions on the 5-position and 8-position of the quinoline ring; in both positions the substitution was either an amino or nitro group. 7 Although not identical to the applicants' claimed compounds, the examiner noted the similar substitution pattern (i.e., at the same positions on the isoquinoline ring) and concluded that a mixed substitution of the invention therefore would have been obvious in view of Zee-Cheng et al.
In a response dated July 14, 1989, the applicants rebutted the Sec. 103 rejection. Applicants asserted that their mixed disubstituted compounds had unexpectedly better antitumor properties than the symmetrically substituted compounds in Zee-Cheng et al. In support of this assertion applicants attached the declaration of Dr. Gerhard Keilhauer. In his declaration Dr. Keilhauer reported that his tests indicated that applicants' claimed compounds were far more effective as antitumor agents than the compounds disclosed in Zee-Cheng et al. when tested, in vitro, against two specific types of human tumor cells, HEp and HCT-29. 8 Applicants further noted that, although the differences between the compounds in Zee-Cheng et al. and applicants' claimed compounds were slight, there was no suggestion in the art that these improved results (over Zee-Cheng et al.) would have been expected. Although the applicants overcame the Sec. 103 rejection, the examiner nevertheless issued a final rejection, on different grounds, on September 5, 1989.
On June 4, 1990, applicants filed a continuation application, Serial No. 533,944 (the '944 application), from the above-mentioned '690 application. Claims 10-13, the only claims remaining in the continuation application, were rejected in a final office action dated May 1, 1991. Applicants appealed the examiner's final rejection to the Board.
In his answer to the applicants' appeal brief, the examiner stated that the final rejection was based on 35 U.S.C. Sec. 112 p 1. 9 The examiner first noted that the specification failed to describe any specific disease against which the claimed compounds were active. Furthermore, the examiner concluded that the prior art tests performed in Paull and the tests disclosed in the specification were not sufficient to establish a reasonable expectation that the claimed compounds had
a practical utility (i.e. antitumor activity in humans). 10
In a decision dated March 19, 1993, the Board affirmed the examiner's final rejection. The three-page opinion, which lacked any additional analysis, relied entirely on the examiner's reasoning. Although noting that it also would have been proper for the examiner to reject the claims under 35 U.S.C. Sec. 101, the Board affirmed solely on the basis of the Examiner's Sec. 112 p 1 rejection. This appeal followed.
At issue in this case is an important question of the legal constraints on patent office examination practice and policy. The question is, with regard to pharmaceutical inventions, what must the applicant prove regarding the practical utility or usefulness of the invention for which patent protection is sought. This is not a new issue; it is one which we would have thought had been settled by case law years ago. 11 We note the Commissioner has recently addressed this question in his Examiner Guidelines for Biotech Applications, see 60 Fed.Reg. 97 (1995); 49 Pat.Trademark & Copyright J. (BNA) No. 1210, at 234 (Jan. 5, 1995).
The requirement that an invention have utility is found in 35 U.S.C. Sec. 101: "Whoever invents ... any new and useful ... composition of matter ... may obtain a patent therefor...." (emphasis added). It is also implicit in Sec. 112 p 1, which reads:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Obviously, if a claimed invention does not have utility, the specification cannot enable one to use it.
As noted, although the examiner and the Board both mentioned Sec. 101, and the rejection appears to be based on the issue of whether the compounds had a practical utility, a Sec. 101 issue, the rejection according to the Board stands on the requirements of Sec. 112 p 1. It is to that provision that we address ourselves. 12 The Board gives two reasons for the rejection; 13 we will consider these in turn.
The first basis for the Board's decision was that the applicants' specification failed to disclose a specific disease against which the claimed compounds are useful, and therefore, absent undue experimentation, one of ordinary skill in the art was precluded from using the invention. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed.Cir.1986), cert. denied, 480 U.S. 947, 107 S.Ct. 1606, 94 L.Ed.2d 792 (1987). In support, the Commissioner argues that the disclosed uses in
the '944 application, namely the "treatment of diseases" and "antitumor substances," are similar to the nebulous disclosure found insufficient in In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967). This argument is not without merit.
In Kirk applicants claimed a new class of steroid compounds. One of the alleged utilities disclosed in the specification was that these compounds possessed "high biological activity." Id. at 938, 153 USPQ at 50. The specification, however, failed to disclose which biological properties made the compounds useful. Moreover, the court found that known specific uses of similar compounds did not cure this defect since...
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