oard of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE WERNER K. MAAS AND CARLTON L. GYLES
Appeal No. 86-0178
May 19, 1987
Application for Patent filed January 12, 1981, Serial No. 224,046. Mutant Enterotoxin of E. Coli.
John W. Schneller for appellants.
Primary Examiner--Christine M. Nucker.
Before Milestone, Goldstein and Winters
Examiners-in-Chief
Winters
ON REQUEST FOR RECONSIDERATION
Appellants request reconsideration of our decision dated February 12, 1987, affirming the examiner's rejection of claims 1 through 23 under 35 USC 101. The basis for the request is appellants' assertion that: (1) our opinion includes a new ground of rejection, not designated as such, and (2) the utility in question is "no longer" sufficiently unusual to justify an examiner's requiring substantiating evidence.
In our original opinion, page 4, second paragraph, we pointed out that "animals have not yet been bred for which appellants' 'vaccine' is useful and the in vivo studies performed thus far have been inconclusive". We adhere to that statement which, in our view, follows logically from the evidence presented in the Francis letter of record. According to the appellants, however, "[t]he Board's comments in this regard were never specified by the Examiner, and therefore constitute a new ground of rejection". See the Request for Reconsideration, page 3. The argument lacks merit.
Appeal to the Board is from a decision of the examiner, not from the reasons upon which such decision is based. See McCrady, Patent Office Practice, 4th edition, § 234 (1959). Apparently, it is appellants' position that whenever the Board sets forth comments which "were never specified" by the examiner, it follows that those comments "constitute a new ground of rejection". We disagree. The criterion of whether a rejection is considered "new" in a decision by the Board is whether appellants have had fair opportunity to react to the thrust of the rejection. In re Kronig, 539 F.2d 1300, 190 USPQ 425 (CCPA 1976). Here, we agree with the examiner's basis for rejecting all the appealed claims, viz., 35 USC 101. We further agree with the examiner that appellants have not provided substantiating evidence on this record to establish that the subject matter defined in claims 1 through 23 possesses a practical utility. The examiner reviewed appellants' evidence, as did this Board. See our original opinion, pages 3 and 4. The basic thrust of the rejection at the examiner and board level was the same, and we believe that appellants have had fair opportunity to react to that rejection. Therefore, we shall not designate our affirmance as constituting a new ground of rejection under the provisions of 37 CFR 1.196(b).
Appellants do not disagree with our assessment that, based on the background information presented in their specification disclosure, the utility in question is sufficiently unusual to justify an examiner's requiring substantiating evidence. Rather, appellants assert that the utility in question is "no longer" sufficiently unusual in view of "significant advances" made in the art of biotechnology in the last six years. See the Request for Reconsideration, page 4. In this regard, we find it sufficient to note that we reviewed this case based on all the evidence of record relating to utility, including (1) appellants' specification, (2) the Maas declaration filed August 4, 1982, and (3) the Francis letter filed August 21, 1984. Evidence pertaining to "significant advances" made in the art of biotechnology, referred to by the appellants, was not made of record. As stated in In re Scarbrough, 500 F.2d 560, 182 USPQ 298 (CCPA 1974), argument of counsel cannot take the place of evidence lacking in the record.
*2 In conclusion, we shall not designate our affirmance as constituting a new ground of rejection and we adhere to our original position that, based on the evidence of record, the subject matter defined in claims 1 through 23 does not possess a practical utility. We therefore decline to modify our original decision or opinion in any respect. Appellants' request for reconsideration has been carefully considered, but is denied with respect to making any changes in our original decision or opinion.
DENIED.
BOARD OF PATENT APPEALS AND INTERFERENCES
Gordon K. Milestone
Melvin Goldstein
Examiner-in-Chief
Sherman D. Winters
Examiner-in-Chief
Appeal from the examiner's decision refusing to allow claims 1 through 23, which are all of the claims in this application.
Claims 1, 4, 7, 10, 12, 13, and 18 are representative:
1. A plasmid which comprises a gene coding for an immunologically active, conjugally transferable, non-toxic, heat-labile enterotoxin and a gene coding for a non-toxic, heat-stable enterotoxin.
4. A strain of Escherichia coli comprising the plasmid of claim 1.
7. The Escherichia coli of claim 4, further comprising a colonization factor.
10. A live vaccine comprising the Escherichia coli of claim 7 and a sterile, pharmaceutically acceptable carrier.
12. A method of vaccinating humans or animals which comprises orally administering the live vaccine of claim 10 or 11.
13. A method for preparing the plasmid of claim 1, which comprises mutating a plasmid containing a gene coding for a heat-labile enterotoxin and a gene coding for a non-toxic, heat-stable enterotoxin and isolating a resulting plasmid comprising a gene coding for an immunologically active, non-toxic, heat-labile enterotoxin and a gene coding for a non-toxic, heat-stable enterotoxin.
18. A method for preparing the Escherichia coli of claim 7, which comprises mating a microorganism having a plasmid containing a gene coding for an immunologically active, non-toxic, heat-labile enterotoxin and a gene coding for a non-toxic, heat-stable enterotoxin with a microorganism having a colonization factor and isolating a resulting microorganism having said plasmid and said colonization factor.
No prior art references are relied on by the examiner. Rather, all of the appealed claims stand rejected on these non-prior art grounds: (1) 35 USC 101 because appellants' claimed subject matter lacks patentable utility, and (2) 35 USC 112, first paragraph because appellants' claims are based on a non-enabling disclosure. See the Examiner's Answer, pages 1 and 2.
Although the examiner, as a matter of form, set forth separate grounds of rejection under 35 USC 101 and 35 USC 112, first paragraph, it is clear from her Answer that the latter rejection is "tied up with the question of operability". See the Answer, page 3. Indeed, based on the examiner's presentation it is our understanding that there is only one issue involved in this case, namely, whether appellants have provided substantiating evidence on this record to establish that the subject matter defined in claims 1 through 23 possesses a practical utility. Otherwise stated, the issue under 35 USC 112 relating to an enabling disclosure is subsumed within the issue under 35 USC 101 relating to patentable utility and we shall treat the case on that basis.
OPINION
*3 We shall sustain this rejection.
Appellants' invention relates generally to the treatment of E. coli-mediated diarrheal diseases and, more specifically, to a method of vaccinating humans or animals to achieve immune protection against pathogenic E. coli. In our view, it is apparent from the background information discussed in appellants' specification that the utility in question is sufficiently unusual to justify an examiner's requiring substantiating evidence. Substantiating evidence may be in the form of animal tests which constitute recognized screening procedures with clear relevance to utility in humans. See Ex parte Krepelka, 231 USPQ 746 (Board of Patent Appeals and Interferences 1986) and cases cited therein.
We have reviewed all the evidence in this case relating to utility, including (1) appellants' specification, (2) the Maas declaration filed August 4, 1982, and (3) the Francis letter attached to appellants' "Second Request for Suspension" which was filed August 21, 1984. It is our judgment, based on a review of all the evidence, that appellants have not established that the subject matter defined in claims 1 through 23 possesses a practical utility in currently available form.
First, although appellants' specification describes certain in vitro experiments, there is no correlation on this record between in vitro experiments and a practical utility in currently available form for humans or animals. It is not enough to rely on in vitro studies where, as here, a person having ordinary skill in the art has no basis for perceiving those studies as constituting recognized screening procedures with clear relevance to utility in humans or animals. The burden is on appellants to establish the significance of the in vitro experiments set forth in their specification. This appellants have not done.
Second, with respect to the Maas declaration, the examiner correctly analyzed the "defect in experimental design" of the in vivo studies described therein. For the reasons well stated by the examiner in the Office Action dated April 19, 1983, (Paper No. 13), paragraph bridging pages 2 and 3, the Maas declaration does not establish that appellants' "vaccine" has utility. In this regard, we adopt the examiner's position as our own and we shall therefore not belabour the record with further comment.
Third, with respect to the Francis letter of record, the letter states that "studies on the potential efficacy of a modified live vaccine for E. coli diarrhea will necessitate identification, breeding, and raising genetically- susceptable swine" and that "one to two years will be required to obtain such animals and to retest the vaccine strain of E. coli". Otherwise stated, animals have not yet been bred for which appellants' "vaccine" is useful and the in vivo studies performed thus far have been inconclusive.
We hold that appellants have failed to provide substantiating evidence on this record establishing that their claimed subject matter possesses a practical utility within the meaning of 35 USC 101. The examiner's decision, refusing to allow claims 1 through 23, is therefore affirmed.
AFFIRMED.
BOARD OF PATENT APPEALS AND INTERFERENCES
Gordon K. Milestone
Examiner-in-Chief
Melvin Goldstein
Examiner-in-Chief
Sherman D. Winters
Examiner-in-Chief
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