Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE ABRAHAM SUDILOVSKY
Appeal No. 90-3171
August 29, 1991
Application for Patent filed March 21, 1988, Serial No. 171,068. Method For Treating Tardive Dyskinesia Employing An Ace Inhibitor.
Burton Rodney et al. for Appellant
Primary Examiner--Lester L. Lee
Before Winters, Goolkasian and Kimlin
This is an appeal from the examiner's final rejection of claims 1, 3-5, 7-10 and 12-23, which are all the claims remaining in the application.
Claim 1 is illustrative and reads as follows:
1. A method for inhibiting onset of or treating tardive dyskinesia in a mammalian specie, which comprises administering to a mammalian specie in need of such treatment an effective amount of an angiotensin converting enzyme inhibitor alone or in combination with a calcium channel blocker, wherein the angiotensin converting enzyme inhibitor is a phosphonate substituted amino or imino acid or salt thereof, a mercapto substituted proline derivative, a mercaptoacyl derivative of a substituted proline, a phosphinylakanoyl proline derivative or a phosphonamidate derivative.
The references relied on by the examiner are: NONE
References cited by the Board:
Cecil, Textbook of Medicine, 18th edition, Vol. 2, 1988, pages 21-49.
Physicians' Desk Reference, 43rd Edition, 1989, page 2080.
Reference relied on by appellant:
Cavanaugh 3,851,055 Nov. 26, 1974
At the outset we note that the claims as appended to the Brief are not the claims before the examiner in the final rejection. The claims in the appendix are those originally presented in the application as filed. During prosecution, however, the claims were amended, claim 1 being amended twice. Our consideration is, of course, concerned solely with the examiner's decision rejecting the amended claims. Claim 1 recited above is the twice amended version which appears at page 1 of the amendment submitted August 3, 1989.
Appellant's invention is directed to a method for (1) inhibiting onset of, or (2) treating a disease known as tardive dyskinesia. Tardive dyskinesia is described in Cecil's Textbook of Medicine as a "most feared complication of antipsychotic drug therapy" which "can persist indefinitely." The disease manifests itself by repetitive, rapid movements which occur in most parts of the body after prolonged exposure to antipsychotic drugs. The symptoms can be largely suppressed by antidopaminergic drugs.
All of appellant's claims stand rejected under 35 U.S.C. § 112 as based on a specification which fails to adequately teach how to use the claimed method effectively to inhibit onset of or treat tardive dyskinesia in mammals. As explained in the Office Action of May 16, 1989, because there are no experimental data or test results set forth in the application or made of record during prosecution supporting the effectiveness of the ACE inhibitors alone or in combination with calcium channel blockers, the examiner is of the opinion that appellant's allegation of utility for ACE inhibitors in the treatment of tardive dyskinesia "is not believable on its face" (Office Action, May 16, 1989, page 4) and, accordingly, the claimed method lacks utility.
*2 Appellant urges that the specification complies with the Manual of Patent Examining Procedure, and that the asserted utility in the present application is "believable on its face in view of the contemporary knowledge of the art." Appellant asserts that it is the examiner's burden to provide adequate support for a rejection based on lack of utility and that the examiner has not done so.
We are in complete agreement with appellant that In re Marzocchi, 439 F.2d 220, 169 USPQ 367 (CCPA 1971) places specific obligations on an examiner whenever a claim is rejected for lack of enablement under the first paragraph of 35 U.S.C. § 112. [FN1] The Marzocchi decision states quite clearly:
... a specification disclosure which contains a teaching of the manner and process of using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein....
... it is incumbent upon the Patent Office, whenever a rejection on this basis is made, to explain why it doubts the truth or accuracy of any statement in a supporting disclosure and to back up assertions of its own with acceptable evidence or reasoning which is inconsistent with the contested statement.
In this instance, the examiner has supplied no objective evidence supporting his doubts but, rather, has supplied "reasoning ... inconsistent with the contested statement." The Marzocchi decision clearly sanctions sound scientific reasoning as an acceptable alternative to patents and printed publications in support of an examiner's holding that a disclosure is not enabling. The only issue, then, is whether or not, in any particular case, the examiner's "reasoning" sufficiently supports a prima facie case of nonenablement. If it does, we must affirm the examiner's rejection when, as in this instance, an appellant has provided no additional evidence of operability, i.e., that either the claimed ACE inhibitors are effective against tardive dyskinesia or those skilled in the art would accept appellant's asserted utility without question. That evidence must necessarily be commensurate in scope with the broad subject matter claimed.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112 were described in Judge Miller's concurring opinion in In re Colianni, 561 F.2d 220, 195 USPQ 150 (CCPA 1977), and adopted by this board in Ex parte Forman, 230 USPQ 546 (BPAI 1986). Among these factors are:
1) the nature of the invention,
2) the state of the prior art,
*3 3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present, and
5) the presence or absence of working examples.
We consider the factors in relationship to the facts before us:
1) Nature of the invention.
Tardive dyskinesia is known as a "most feared" complication of drug therapy. The Cavanaugh reference cited by appellant describes the disease as a "most serious psychiatric problem." Because the disease is labelled by the art as "most feared" and "most serious," there is a reasonable likelihood that a satisfactory remedy for the disease does not presently exist.
2) State of the art.
ACE inhibitors as a class are not recognized as effective agents against tardive dyskinesia. Indeed, during prosecution, the examiner cited U.S. Patent No. 4,652,641 to Parsons which was directed to novel ACE inhibitors. That patent states that some of the compounds described therein also were antagonists of cholecystokinin (CCK) but were "relatively weak antagonists" (column 2, line 8). Parsons teaches that it is because of the antagonist ability of some of the compounds against CCK that the compounds are effective against dyskinesia type diseases. In other words, Parsons indicates that it is the CCK antagonist activity and not ACE activity which determines activity against tardive dyskinesia. [FN2]
During prosecution, in overcoming a rejection over the Parsons reference, appellant asserted that not all of the Parson compounds were described by Parsons as useful against CCK and that it would not have been obvious to one skilled in the art which benzofused lactams of Parsons would be antagonists of CCK and thus useful in treating tardive dyskinesia. However, all of Parsons compounds were described as angiotensin inhibitors. Accordingly appellant's arguments against the applicability of the Parsons reference amount to an admission that the state of the art was such that angiotensin inhibitors as a class were not generally recognized as useful against tardive dyskinesia. Accordingly, the state of the prior art is that appellant's assertions of utility of ACE inhibitors [FN3] in general and the particular ACE inhibitors claimed herein for treatment of tardive dyskinesia would not have been readily accepted by those skilled in the art.
Appellant's invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable.
In the case before us the bulk of the specification, though highly detailed, is devoted solely to a description of compounds stated to be known ACE inhibitors. The remainder of the specification is directed to how to make tablets and solutions for injection. Any disclosure regarding utility is confined to broad allegations and suggestions without substantiating working examples. As stated in In re Glass, 492 F.2d 1228, 181 USPQ 31, 35 (CCPA 1974), "the strong feeling one gets from reading the entire specification is that either appellant did not have possession of the details of a single operative process or, if he did, he chose not to divulge them."
*4 5) Working examples.
Appellant has provided no working examples or experimental evidence regarding the effectiveness of the claimed ACE inhibitors against the disease. Though not controlling, the lack of working examples is, nevertheless, a factor to be considered in a case involving both physiological activity and an undeveloped art. When a patent applicant chooses to forego exemplification and bases utility on broad terminology and general allegations, he runs the risk that unless one with ordinary skill in the art would accept the allegations as obviously valid and correct, the examiner may, properly, ask for evidence to substantiate them. In re Novak, 306 F.2d 924, 134 USPQ 335 (CCPA 1962) [FN4] ; In re Fouche, 439 F.2d 1237, 169 USPQ 429 (CCPA 1971).
In this case, the only evidence of utility provided by appellants is U.S. Patent No. 3,851,055 to Cavanaugh which teaches that a particular chemical compound having a tripeptide structure is useful against tardive dyskinesia. There is no suggestion in Cavanaugh that the compound is an ACE inhibitor and, importantly, there is no similarity between the compound of Cavanaugh and the compounds of appellant's method claims, especially when the compounds used in the claimed process are either mercapto or phosphorous containing chemicals and those of Cavanaugh are not.
We are of the opinion that the examiner's rejection of appellant's claims under 35 U.S.C. § 112 for lack of enablement is reasonably based and, accordingly, we affirm the rejection.
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
Sherman D. Winters
John T. Goolkasian
Edward C. Kimlin
FN1. We note that reliance on either or both 35 U.S.C. § 101 and 35 U.S.C. § 112, first paragraph, as the statutory basis for this type of rejection has been judicially approved. In re Fouche, 439 F.2d 1237, 169 USPQ 429 (CCPA 1971).
FN2. Parsons comments are in accord with comments in Cecil's Textbook of Medicine.
FN3. Interestingly, appellant's specification says nothing about the CCK inhibiting ability of the angiotensin inhibitors used in the claimed process. Indeed, the 1989 version of the Physicians' Desk Reference includes for the first time a description of Captopril (an ACE inhibitor within the claims) and states nothing about the ability of that compound to either inhibit CCK or act medicinally in the treatment of tardive dyskinesia.
FN4. As in Novak, supra, appellant herein has provided no evidence that one skilled in the art would accept "without question" that appellant's ACE inhibitors are effective against tardive dyskinesia.
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