Case Name: Application of William D. COLIANNI
Court: United States Court of Customs and Patent Appeals
Jurisdiction: United States
Decision Date: 1977-09-15
Citations: 561 F.2d 220
Docket Number: Patent Appeal No. 76-735
Parties: Application of William D. COLIANNI.
Judges: 
Reporter: Federal Reporter 2d Series
Volume: 561
Pages: 220–226

Head Matter:
Application of William D. COLIANNI.
Patent Appeal No. 76-735.
United States Court of Customs and Patent Appeals.
Sept. 15, 1977.
Rehearing Denied Oct. 20,1977.
Fred S. Lockwood, Chicago, Ill., Lockwood, Dewey, Zickert & Alex, Chicago, Ill., attorney of record, for appellant.
Joseph F. Nakamura, Washington, D. C., for the Commissioner of Patents, Gerald H. Bjorge, Washington, D. C., of counsel.
Before MARKEY, Chief Judge, and RICH, BALDWIN, LANE and MILLER, Judges.

Opinion:
RICH, Judge.
This appeal is from the decision of the Patent and Trademark Office Board of Appeals (board) affirming the rejection, under 35 USC § 112, first paragraph, of claims 1-6, which are all the claims present in appellant's application serial No. 200,932, filed November 22, 1971, entitled "Bone Fusing Method." The board's unanimous decision was adhered to on reconsideration, one member dissenting. We affirm.
Appellant's Disclosure
To place the issue on this appeal in perspective, appellant's brief application, less formal portions, is reproduced in its entirety:
Abstract of the Disclosure
A method of rapidly mending a fractured bone by application of ultrasonic energy thereto at the site of the fracture so as to produce a fusion-like or weld-like mend. The mending action may be assisted by introduction of plastic and/or bone powder at the site of the fracture.
SPECIFICATION
This invention relates to innovations and improvements in the accelerated mending of fractured animal bones by proper application to the fractures of ultrasonic energy.
The object of the invention, generally stated, is the use of ultrasonic energy to mend fractured animal bones, the ultrasonic energy being applied to a bone at the site of the fracture therein so as to produce thereat a fusion-like or weld-like mend.
Certain other more specific objects of the invention will, in part, be obvious and will in part appear hereinafter.
For a more complete understanding of the nature and scope of the invention reference may be had to the following detailed description thereof taken in connection with the accompanying drawings wherein:
Fig. 1 is a diagrammatic elevational view illustrating the manner in which and the apparatus by which my invention may be applied to a fracture in the bone of a living animal; and
Fig. 2 is a sectional view on an enlarged scale taken on line 2-2 of Fig. 1.
The principle underlying the present invention is to in a suitable manner apply sufficient ultrasonic energy to a bone at the site of a fracture therein so that as a result of the high frequency vibration imparted to the bone sufficient friction is generated at the site so that the resultant effect will be to create a fusion-like or weld-like mend at the fracture. The ultrasonic energy is dissipated at the site of the fracture, being localized at and confined to the fracture. The action is fast and usually ultrasonic energy needs to be applied for less than a minute.
Referring to Figs. 1 and 2, a section of a human forearm is indicated at 5 in broken outline with a length of the ulna bone, for example, indicated at 6 with a fracture therein designated at 7.
By use of appropriate technique selected by the surgeon the hook portions 8 and 10 of a pair of elements 11 and 12 respectively are implanted in the arm so as to hook around the ulna 6 from opposite sides of the fracture 7 and closely adjacent thereto. The elements 11 and 12 may be formed from stainless steel wire having sufficient stiffness to transmit ultrasonic vibrations. The straight end of each of the hook elements 11 and 12 is clamped in the jaws of a Jacobs chuck of the known type used for clamping and holding the ends of drill bits in an electric drill. These clamps are indicated at 13 and 14, respectively, and are carried by ultrasonic generators of known commercial type indicated at 15 and 16, respectively. Such ultrasonic generator units are available commercially in various capacities, e. g. the Sonocone Unit, Power-tron Division, Giannini Controls Corp., New York, New York.
With the hook elements 11 and 12 properly implanted and the hook portions 8 and 10 thereof properly attached to the bone 6, and with the shank ends of the elements 11 and 12 properly clamped in the chucks 13 and 14, the ultrasonic generators 15 and 16 may be energized. Depending on the type or character of the fracture 7, it may be necessary to apply pressure to the fracture from opposite sides when the ultrasonic energy is applied. The high frequency vibrations produced by the generators are transmitted through the elements 11 and 12 which vibrate in the direction of the shank portions thereof at a frequency and intensity that depends upon the setting of the generator 15 or 16. The vibrations are transmitted to the broken bone and result in the ultrasonic energy being localized at and confined to the fracture 7. The result is to produce a fusion-like or weld-like mend where the fracture 7 existed.
The mending action produced by the heat friction resulting from the application of ultrasonic energy may be augmented by introducing a suitable orthopedic plastic and/or bone powder to the fracture.
It will be understood that in certain cases it may be advantageous to apply ultrasonic energy to the bone on only one side of a fracture.
The 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, the rigidity with which the bone is connected to the generator, etc. It will be understood that the intensity or degree of the action must not be such as to appreciably denature the muscle or tissues in the vicinity of the fracture. In other words, the temperature generated by the friction of the bone rapidly vibrating at the fracture under pressure must be localized at the site of the fracture and heat must be rapidly withdrawn from the site of the fracture.
It will be appreciated that in order to apply the invention to different bones and different types of fractures ranging from hair line through compound, a variety of elements or tools may be designed and fashioned for purposes of transmitting ultrasonic energy from the generators to a bone at the site of the fracture therein and that various surgical techniques may be used for attaching or implanting these elements or instruments to the bone on either or both sides of the fracture.
The 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 and technique. In certain instances it may be necessary for the surgeon or operator to fashion special tools or instruments and it will be understood that the foregoing description in connection with Figs. 1 and 2 are illustrative of the general principles as well as setting forth one particular manner in which the invention may be practiced.
WHAT IS CLAIMED AS NEW IS:
1. The method of rapidly mending fractured animal bones which comprises applying sufficient ultrasonic energy by direct mechanical subcutaneous connection to the bone on at least one side of the fracture therein to join the bone together at the fracture.
2. The method of claim 1 wherein ultrasonic energy is applied to the bone on both sides of the fracture adjacent thereto.
3. The method of claim 1 wherein thermoplastic material is introduced into the site of said fracture and is fused on said application of ultrasonic energy and thereafter solidifies.
4. The method of claim 3 wherein bone powder is introduced into the site of said fracture in addition to said thermoplastic material.
5. The method of claim 1 wherein said ultrasonic energy is transmitted to said bone through a pair of hook-like elements having the hook portions attached to the bone.
6. The method of claim 5 wherein said hook-like elements are hooked over opposite sides of said bone with the shank portions thereof extending in approximately opposite directions.
OPINION
The board and the examiner rightly questioned the adequacy of appellant's disclosure. The application of "sufficient" ultrasonic energy is essential to appellant's claimed method, yet his 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. There is not a single specific example or embodiment by way of an illustration of how the claimed method is .to be practiced. Appellant's specification leaves these matters to "general criteria" (which are left undefined) and states that those wishing to practice his method "will apply the appropriate apparatus and tech- ñique," but does not disclose how this would be accomplished. Before the board, in his petition for reconsideration, appellant argued that the "routine way to proceed" would be via in vivo experiments with laboratory animals.
The degree of disclosure and the nature of the art in this case are generally parallel to those in In re Gardner, 427 F.2d 786, 57 CCPA 1207, 166 USPQ 138 (1970), in which we found the specification not to comply with 35 USC 112, first paragraph. As the dissent points out, there is of record a Russian publication which describes an ultrasonic bone-mending method which was developed via in vivo experiments with animals, and in which the parameters for applying the ultrasonic energy are quantified. Other than stating in his brief that the court "may be interested" in this publication, appellant does not rely on it. It is not appropriate to comment, as the dissent does, on the effect of that publication on the issue before us.
The decision of the board is affirmed.
AFFIRMED.
MILLER, Judge,