In re Colianni

concurring.

The issue in this case is simple: On this record, has appellant provided sufficient guidelines for one of ordinary skill in the art to practice the claimed invention without undue experimentation? See In re Stephens, 529 F.2d 1343 , 188 USPQ 659 (Cust. & Pat. App. 1976).

This involves the threshold determination of which party bears the burden of proof on the issue of undue experimentation. In the recent case of In re Angstadt, 537 F.2d 498 , 190 USPQ 214 (Cust. & Pat.App.1976), a majority of this court asserted that “[s]howing that the disclosure entails undue experimentation is part of the PTO’s initial burden under [In re Armbruster, 512 F.2d 676 , 185 USPQ 152 (Cust. & Pat.App.1975)].” Id. at 504, 190 USPQ at 219 . This, however, would place a difficult, if not impossible, burden on the PTO, which would have to establish that one of ordinary skill in the art lacks the requisite knowledge to practice the claimed invention by demonstrating that the experimentation required is undue. In the case of an inadequate enabling disclosure, the PTO would have to determine its inadequacies (e. g. the guidelines the applicant failed to provide) and then show that these cannot be overcome except by undue experimentation. The practical approach, followed consistently by this court prior to Angstadt , is to place the initial burden on the PTO to show that the enabling disclosure is not commensurate in scope with the claims. Upon such a showing, the burden of rebuttal shifts to the applicant. In re Ghiron, 442 F.2d 985, 992 , 58 CCPA 1207, 1215, 169 USPQ 723 , 728 (1971); see also In re Dinh-Nguyen, 492 F.2d 856 , 181 USPQ 46 (Cust. & Pat.App.1974); In re Marzocchi, 439 F.2d 220, 223 , 58 CCPA 1069, 1073, 169 USPQ 367 , 369 (1971); In re Cook, 439 F.2d 730 , 58 CCPA 1049, 169 USPQ 298 (1971).

The board here questioned appellant’s disclosure by noting that there was no “teaching concerning an operative range of the desired frequency of ultrasonic energy, its duration or its intensity.” The board also noted that there did not appear to be “any residual knowledge” in the prior art concerning appellant’s invention and that the Knoch reference taught that indirect application of high doses of ultrasonic energy could lead to spontaneous bone fractures. Thus, the PTO provided sufficient evidence and reasoning to make a prima facie showing that appellant’s disclosure was not commensurate in scope with the claimed invention (which requires mending of the fracture). Moreover, Judge Rich’s opinion, in stating that “[t]he board and the examiner rightly questioned the adequacy of appellant’s disclosure,” appears to have abandoned the initial burden test of Ang-stadt and correctly applied the law by shifting the burden to appellant. 1 Appellant, presumably knowledgeable in this particu *224 lar art, did not rebut the PTO’s evidence or reasoning. He failed to establish that the knowledge of one skilled in the art was sufficient to enable such a person to practice the claimed invention without undue experimentation.

In determining what constitutes undue experimentation, many factors are to be taken into account. The quality of any necessary experimentation would clearly be undue when “ingenuity beyond that to be expected of one of ordinary skill in the art” is required. Fields v. Conover, 443 F.2d 1386, 1391 , 58 CCPA 1366, 1372, 170 USPQ 276 , 279 (1971). By its reliance on In re Gardner, 421 F.2d 786, 57 CCPA 1207, 166 USPQ 138 (1970), Judge Rich’s opinion indicates that the quantity of necessary experimentation (i. e., “a great amount of work”) may be undue. Id., 427 F.2d at 789 , 57 CCPA at 1212, 166 USPQ at 141 . However, an extended period of experimentation may not be undue if the skilled artisan is given sufficient direction or guidance. Cf. In re Cook, 439 F.2d 730, 732 , 58 CCPA 1049, 1052, 169 USPQ 298 , 300 (1971). Other factors to be considered are the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims. See In re Stephens, supra; In re Fisher, 427 F.2d 833, 839 , 57 CCPA 1099, 1108, 166 USPQ 18 , 24 (1970); In re Rainer, 377 F.2d 1006 , 54 CCPA 1445, 153 USPQ 802 (1967); In re Honn, 364 F.2d 454 , 53 CCPA 1469, 150 USPQ 652 (1966).

On the record before us and taking all of the above factors into account, I cannot agree with the dissenting opinion that en-ablement commensurate in scope with the claims has been shown. Not a single working example has been disclosed. 2 More importantly, appellant has failed to provide any guidance in selecting operating parameters that would yield the claimed result of “mending.” 3 All that appellant has disclosed is that “sufficient” ultrasonic energy be applied using “the appropriate apparatus and technique.” However, as far as the record shows, there are no established criteria or techniques of which the skilled practitioner would be aware. This case demonstrates the necessity for guidance where the scope of protection sought by the claims is broad. As I pointed out in my dissenting opinion in In re Angstadt, supra at 508 , 190 USPQ at 222 :

The need for guidance to enable the invention, with its claims to a myriad of combinations . . ., to be practiced without undue experimentation is evident.

Accord, In re Eltgroth, 419 F.2d 918, 921 , 57 CCPA 833, 837, 164 USPQ 221 , 223 (1970); In re Rainer, supra.

I agree with the dissenting opinion that the Russian publication is evidence of what one skilled in .the art would know as of appellant’s filing date. Therefore, it is relevant evidence regardless of whether appellant relies on it. However, as pointed out by the board, the Russian publication does not appear to utilize direct subcutaneous application of ultrasonic energy and, thus, specific operating parameters there dis *225 closed may well be inapplicable to appellant’s method. In such an undeveloped and unpredictable area, the publication is entitled to little weight.

. The dissenting opinion correctly states the PTO’s initial burden “of giving reasons, supported by the record as a whole, why the specification is not enabling.” The dissent also recognizes that Judge Rich’s opinion apparently abandons the Angstadt initial burden test.

. Although “there is no magical relationship between the number of representative examples and the breadth of the claims” with respect to enablement, In re Borkowski, 422 F.2d 904, 910 , 57 CCPA 946, 952-53, 164 USPQ 642 , 646 (1970), and the dissenting opinion correctly points out that “Compliance with 35 USC 112, first paragraph, does not turn on whether a “specific example ... is disclosed,” the lack of a working example is nonetheless a factor to be considered, especially in a case involving an unpredictable and undeveloped art. Compare In re Stephens, supra (“The references show that the art is highly advanced, as would be expected for one so ancient.”).

. The statement by Judge Rich that appellant’s specification does not disclose what a “sufficient dosage of ultrasonic energy might be or how those skilled in the art might make the appropriate selection of frequency, intensity, and duration” and his citation to Gardner indicate that guidance must be supplied in a case such as this. As pointed out in Gardner, 427 F.2d at 789 , 57 CCPA at 1212, 166 USPQ at 141 :

But our view of the law requires that the disclosure in the application shall inform [those skilled in the art] how to use, not how to find out how to use for themselves.