In re Bundy

• Decision Date: 26 February 1981
• Docket Number: Appeal No. 80-591.
• Citation: 642 F.2d 430
• Parties: In re Gordon L. BUNDY.
• Court: U.S. Court of Customs and Patent Appeals (CCPA)

642 F.2d 430

In re Gordon L. BUNDY.

Appeal No. 80-591.

United States Court of Customs and Patent Appeals.

February 26, 1981.

Robert A. Armitage, Kalamazoo, Mich., for appellant.

Joseph F. Nakamura, Sol., for Patent & Trademark Office; Gerald H. Bjorge, Washington, D. C., of counsel.

Before MARKEY, Chief Judge, and RICH, BALDWIN, MILLER and NIES, Judges.

NIES, Judge.

This appeal is from the decision of the Patent and Trademark Office (PTO) Board of Appeals (board) affirming the rejection of the sole claim of appellant's application¹ under the first paragraph of 35 U.S.C. § 112.² We reverse.

The appeal raises questions regarding the extent to which new pharmaceuticals must be tested, preceding the filing of an application, in order to satisfy the how-to-use and best mode requirements of § 112.

The Invention

The invention relates to a new series of analogs of naturally-occurring prostaglandins³ which differ from the corresponding known prostaglandins in that these analogs have a methylene group at the C-9 position.⁴ Structurally, the compounds may be considered analogs of either E-type prostaglandins (PGEs) in which the methylene group replaces the usual C-9 keto- or oxo-group or of F-type prostaglandins (PGFs) in which the methylene group replaces the C-9 hydroxyl group. Pharmacologically, however, the analogs are related only to PGEs.

The sole claim reads:

The Disclosure

The specification of U. S. Patent No. 4,060,534 ('534) has been incorporated by reference to serve as the specification for the present application. The portions of the specification directed to using these novel analogs are pertinent to the issues on appeal.

The background section of the specification contains a detailed description of the uses of various known PGEs. Nine specific biological responses caused by PGEs, ranging from decreasing blood pressure to inhibiting gastric secretion, are listed. Based on these responses, various pharmacological uses with broad ranges of dosage by various methods of administration are enumerated.

The use of appellant's novel analogs, which include not only the claimed compounds of this application, but also those claimed in other divisional applications and in '534, is subsequently set forth:

The novel prostaglandin analogs of this invention correspond to the prostaglandins described above in that the novel prostaglandin analogs exhibit prostaglandin-like activity.

Specifically the 9-deoxy-9-methylene-PGF-type compounds of this invention correspond to the PGE compounds described above, in that these novel 9-deoxy-9-methylene-PGF-type compounds are useful for each of the above-described purposes for which the PGE compounds are used, and are used in the same manner as the PGE compounds, as described above.

The PGE compounds described above, are all potent in causing multiple biological responses even at low doses. Moreover, for many applications, these prostaglandins have an inconveniently short duration of biological activity. In striking contrast, the novel prostaglandin analogs of this invention are substantially more selective with regard to potency in causing prostaglandin-like biological responses, and have a substantially longer duration of biological activity. Accordingly, each of these novel prostaglandin analogs is surprisingly and unexpectedly more useful than one of the corresponding prostaglandins described above for at least one of the pharmacological purposes indicated above for the latter, because it has a different and narrower spectrum of biological potency than the known prostaglandin, and therefore is more specific in its activity and causes smaller and fewer undesired side effects than when the prostaglandin is used for the same purpose. Moreover, because of its prolonged activity, fewer and smaller doses of the novel prostaglandin analog are frequently effective in attaining the desired result.

The specification includes a disclosure relating to preparation of the compounds generally, and several specific examples. None, however, are compounds within the subgenus claimed in this application.

No example of a specific use of any of the disclosed prostaglandin analogs, i. e., setting forth a dosage to achieve a desired response, is given.

The Rejection

The examiner rejected the sole claim under the first paragraph of 35 U.S.C. § 112 as being "inadequately supported by the instant specification" in that not a single example was directed to one of the claimed compounds. Failure to meet the best mode requirement was also raised on the basis of no exemplification. Reliance on utilities similar to known PGEs was attacked on the basis of a statement in a "Samuelsson et al. reference" (more correctly, a Rosenthale paper therein)⁵ that "small changes in the prostaglandin molecule can alter potency or even induce diametrically opposite pharmacologic effects." Thus, the utilities asserted on the basis of those known for structurally analogous compounds were said to be "at best highly speculative."

Before the board the § 112 rejection was more specifically explained by the examiner to encompass an inadequate disclosure of: (1) the description of the compounds; (2) the preparation of the same; (3) their use; and (4) the best mode of carrying out the invention. The examiner added that an undue amount of experimentation would be required to prepare the claimed compounds and to determine their utilities.

The board held that the description and how-to-make requirements of the first paragraph of 35 U.S.C. § 112 were satisfied by appellant's disclosure. It agreed with the examiner, however, that:

Undue experimentation would be required on the part of one of ordinary skill in the relevant art to determine how to use the compounds claimed. Since we consider the manner of using a compound to be necessarily a part of "the best mode contemplated by the inventor of carrying out the invention", we also agree with the examiner's position that the best mode requirement has not been met.

The challenge raised by the examiner's citation of the Rosenthale paper was deemed reasonable and unrebutted by any factual evidence. The board then added:

One of the advantages alleged for the compounds here claimed is that they are more selective than the analogous PGE compounds. This is an express indication that not all of the compounds covered by appellant's claims will induce the same biological responses.

Accordingly, the board affirmed the examiner's rejection of the sole claim to the extent it was based on the how-to-use and best mode requirements of § 112.

OPINION

How-to-Use

The enablement question present here is whether the disclosure of utility in terms of being useful and used in the same manner as known PGEs is sufficient to satisfy the how-to-use requirement of the first paragraph of 35 U.S.C. § 112.

The PTO must have adequate support for its challenge to the credibility of applicant's statements as to utility. Only then does the burden shift to appellant to provide rebuttal evidence. In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Marzocchi, 58 CCPA 1069, 439 F.2d 220, 169 USPQ 367 (1971). We must consider the Rosenthale paper in its entirety in determining the reasonableness of the doubt raised by the authors' conclusory statement relied on by the examiner, and in so doing see no specific evidence that structural variations of PGEs cause opposite pharmacologic effects. The tests reported by Rosenthale do indicate shifts in PGF2a activity from bronchoconstrictor to broncodilator concomitant with structural changes. For PGEs Rosenthale shows only variations in potency, a matter of degree of activity. Accordingly, we do not agree that Rosenthale is sufficient support for the examiner's position that the subject analogs, related as they are to PGEs in pharmacological activity, may not be useful at all to achieve a particular response.

The board focused on another reason for challenging the disclosure as non-enabling. Appellant's disclosure of increased "selectivity" of the novel analogs was taken as an express indication that it was uncertain "which compound will induce which biological responses ...," thus virtually ensuring that an undue amount of experimentation would be required to use the invention. The ranges of dosage for known PGEs, assuming their applicability to appellant's analogs, were said to be very broad and would, in any event, provide little guidance in determining dosages for the more selectively functional claimed analogs.

Appellant contends that the disclosure teaches that all novel compounds exhibit each of the enumerated pharmacological...