In re Colianni

LANE, Judge,

dissenting, with whom BALDWIN, Judge, joins.

With all due respect, I cannot agree with the majority opinion. Appellant discloses and claims a method of mending fractured animal bones by directly applying ultrasonic energy to the region of the fracture. The Patent and Trademark Office (PTO) board majority expressly stated that it believed appellant’s assertion that application of sufficient energy would mend a fractured bone. Thus, given that appellant’s method will mend bone fractures, the only issue before us is whether appellant’s specification is sufficient to enable one of ordinary skill in this art to practice the invention without undue experimentation. I believe that it is. The specification discloses ample detail for performing the claimed method. Specifically, stainless steel wire hooks, which extend from known commercial ultrasonic generators, are implanted and attached to one or both sides of the fracture. The high frequency vibrations produced by the generators are transmitted through the hooks to the broken bone and result in ultrasonic energy being localized at, and confined to, the fracture. The result is a fusion-like or weld-like mend where the fracture had been. Appellant’s specification states that “[t]he intensity of the ultrasonic energy and the length of application will depend upon each particular case or fracture but will follow general criteria. The surgeon or operator will evaluate each fracture case and apply the appropriate apparatus or technique.” As to the duration of application, the specification further states that “[t]he mending action occurs rapidly in a matter of a few seconds to up to a couple of minutes depending upon the intensity of the energy, the nature of the fracture, . . . etc.” In addition to appellant’s specification, a Russian publication, which was submitted to the PTO by appellant, sets forth specific parameters and discloses definite ranges for these parameters that were found to produce satisfactory results. Since this publication is part of the record, cf. In re Cofer, 354 F.2d 664 , 53 CCPA 830, 148 USPQ 268 (1966), and was presumably available to one of ordinary skill in this art when appellant’s application was filed, it is evidence which may be considered on the issue of enablement. Considering the record as a whole, I am convinced that a person of ordinary skill in this art, viz., the skilled orthopedic surgeon or the skilled veterinarian, would be able to determine by routine experimentation the appropriate intensity and duration of ultrasonic energy needed for any given fracture.

The majority states that “[t]he board and the examiner rightly questioned the adequacy of appellant’s disclosure.” Mere questioning, however, is not enough; the PTO has the burden of giving reasons, supported by the record as a whole, why the specification is not enabling. At best, the PTO has only pointed out that some experimentation would be required. As a majority of the court stated recently in In re Angstadt, 537 F.2d 498, 504 , 190 USPQ 214, 219 (Cust. & Pat.App.1976), “this court has never held that evidence of the necessity for any experimentation, however slight, is sufficient to require the applicant to prove that the type and amount of experimentation needed is not undue.” (Emphasis in original.)

The majority further states that “[tjhere is not a single specific example or embodiment by way of an illustration of how the claimed method is to be practiced.” While it is true that there is no “specific example” which uses “specific” values of frequency, intensity, and duration, it is my view that the majority’s emphasis on this point is misplaced. Compliance with 35 USC 112, first paragraph, does not turn on whether a “specific example,” or what is commonly referred to as a working example, is disclosed. The test is whether one skilled in the art could practice the claimed invention without undue experimentation. In re Stephens, 529 F.2d 1343 , 188 USPQ 659 (Cust. & Pat.App.1976); In re Gay, 309 F.2d 769 , *226 50 CCPA 725, 135 USPQ 311 (1962). Moreover, even if such a working example were given, it would be of little help since the frequency, intensity, and duration required for other fractures will depend upon sundry factors including, inter alia, the type of fracture, where it is located, how severe it is, etc. Anyone seeking to use the invention to mend a specific fracture, even if it were the same type as one disclosed in an example, would still have to determine by routine experimentation the appropriate values of frequency, intensity, and duration, since these values will vary from case to case.

Appellant has disclosed his invention broadly. In this art, as in Angstadt , the performance of trial runs using different frequencies, intensities, and times of exposure is “reasonable," even if the result of each trial is uncertain. The kind of specificity which the majority seems to contemplate is unrealistic in view of the nature of the invention and would have the negative effect of discouraging inventors from filing patent applications in an unpredictable area. The majority seems to want everything predictable in advance, which is impracticable and unreasonable.

Finally, in Angstadt , the majority held that “the evidence as a whole negates the PTO position that persons of ordinary skill in this art, given its unpredictability, must engage in undue experimentation . . .. The key word is ‘undue,’ not ‘experimentation.’ ” (Emphasis in original.) 537 F.2d at 504 , 190 USPQ at 219 . I fail to see why this holding should not be dispositive of the case at bar.