Dance, In re

Decision Date30 October 1998
Docket NumberNo. 97-1229,97-1229
Citation160 F.3d 1339,48 USPQ2d 1635
PartiesIn re Creg W. DANCE, John V. Hoek and Victor R. Blackledge.
CourtU.S. Court of Appeals — Federal Circuit

Grady J. Frenchick, Stroud, Stroud, Willink Thompson & Howard, Madison, Wisconsin, argued for appellants Dance, et al. Of counsel on the brief was Karen B. King.

David J. Ball, Jr., Associate Solicitor, Office of Solicitor, Arlington, Virginia, argued for appellee, Commissioner of Patents and Trademarks. With him on the brief were Nancy J. Linck, Solicitor, Albin F. Drost, Deputy Solicitor, and Scott A. Chambers, Associate Solicitor.

Before MAYER, Chief Judge, NEWMAN and GAJARSA, Circuit Judges.

PAULINE NEWMAN, Circuit Judge.

Creg W. Dance, John V. Hoek, and Victor R. Blackledge (collectively "Dance") appeal the decision of the Board of Patent Appeals and Interferences 1 rejecting claims 33 and 35-37 of United States Patent application Serial No. 08/162,572, entitled "Vascular Occlusion

                Removal Devices and Methods."   We affirm the Board's decision
                
BACKGROUND

The subject matter sought to be patented is a catheter for removing an obstruction such as a thrombus in a blood vessel. Figure 2 of the Dance application depicts an embodiment:

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

In operation, the head of the device is rotated in the vicinity of the obstruction, and fluid is supplied through the catheter tube, whereby structure just behind the head generates turbulence to break up or erode the obstruction. The debris of the obstruction is removed by aspiration through the catheter. Referring to Figure 2, drive cable 14 is attached to catheter head 16 and rapidly rotates the head. Turbulence generating means such as facets, impellers or flats 26 are located at the neck 25 of head 16. Ports 28 direct fluid supplied by the operator to the zone of turbulence. The operator aspirates fluid and debris through aspiration port 21.

Figure 16 of the application is described by Dance as the preferred embodiment, encompassed by dependent claims 36 and 37 2:

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

In this embodiment the head 16 is ad 16 is rotated, and fluids to aid in the dissolution course through header 110 to fluid output ports 46. A guide wire is shown at 100.

Claim 33 is representative:

33. A catheter for removing an obstruction in a body vessel comprising:

a flexible, tubular sleeve having distal and proximal ends, said sleeve having extending substantially coaxially therethrough so as to project therefrom;

drive means, said drive means being flexible and rotatable, having fixedly mounted on its projecting end;

head means, said head means comprising a bulbous head, said head being mounted on said drive means so as to be rotated thereby, said head means further including;

turbulence generating means, said catheter further comprising;

means for delivering fluid proximate to the distal end of said sleeve, and

means for recovering fluid and debris from proximate the proximal end of said sleeve.

The examiner rejected the claims as obvious over Kensey, U.S. Patent No. 4,747,821, in view of Sullivan, U.S. Patent No. 4,950,238. 3 Figure 2 of Kensey follows:

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

The Examiner found that Kensey describes ey describes all but one element of claim 33. Described are the rotatable bulbous head driven by a cable, turbulence generating facets, and ports for fluid delivery. Missing is the "means for recovering fluid and debris," which the examiner found in Sullivan.

Sullivan describes a catheter with a rotating head, which may also deploy balloons to surround the obstruction while it is broken up by turbulence created by the rotation. Sullivan shows a return channel for removing the obstruction debris from the sealed area. The examiner held that Sullivan's teaching of debris recovery "from the blockage released by the turbulent flow of the fluid," col. 3, lines 7-8, for purposes of observation and analysis by the physician, id. at lines 10-11, provided the suggestion or motivation to combine Kensey's catheter with Sullivan's recovery means. The examiner summarized the basis of his conclusion of obviousness as follows:

Kensey et al. discloses (Figure 2) a catheter (20) for removing an obstruction in a body vessel comprising a flexible, tubular sleeve (30) having distal and proximal ends, drive means (48) extending substantially coaxial through said sleeve, head means (24) comprising a bulbous head mounted on said drive means, turbulence generating means (Col. 5, lines 48-56) and ports (61) in the head means for delivering fluid proximate said distal end....

Kensey et al. does not disclose fluid recovering means. Sullivan discloses a similar device in which means for recovering fluid and debris are provided (Col. 3, lines 6-12). It would have been obvious to one of ordinary skill in the art to have modified the device of Kensey et al. with a fluid recovery means such as that disclosed by Sullivan in order to allow for the withdrawal of debris from the blockage for subsequent observation and analysis by a physician.

Before the Board, Dance argued that the examiner's mode of analysis by combining the Kensey and Sullivan devices constituted an improper hindsight reconstruction of the claimed invention. Dance also argued that Kensey teaches away from the addition of another channel to recover the debris, because (1) Kensey teaches that in its catheter the particles of the blockage are repeatedly broken down until they become part of a highly emulsified solution that does not require recovery, and (2) a stated advantage of Kensey is the simplicity of his device and its mode of operation. Dance states that his device eliminates disadvantages of both the Kensey and Sullivan catheters. Dance states that he obtains at least partial disintegration of the obstruction by turbulent or vortex action, and then removes the particles lest they enter the bloodstream.

The Board rejected Dance's argument that Kensey by its emulsification of debris teaches away from the addition of a channel for recovering fluid and debris, reasoning that such emulsification would not have discouraged an artisan from recovering the debris as taught by Sullivan. The Board also rejected the argument that Kensey's goal of

                simplicity teaches away from the addition of another channel, stating that an artisan would recognize the "trade-off" as a matter of "common sense."   The Board found that Sullivan provides "more than ample motivation to the artisan to provide the vascular catheter of Kensey with an additional channel in order to achieve Sullivan's expressly stated advantage of enabling the debris not only to be removed from the occlusion site, but also to be filtered out for the purpose of observation and analysis," and held the Dance device unpatentable for obviousness
                
DISCUSSION

Obviousness is a question of law based on findings of underlying facts relating to the prior art, the skill of the artisan, and objective considerations. See Graham v. John Deere Co., 383 U.S. 1, 17, 86 S.Ct. 684, 15 L.Ed.2d 545, 148 USPQ 459, 467 (1966). To establish a prima facie case of obviousness based on a combination of the content of various references, there must be some teaching, suggestion or motivation in the prior art to make the specific combination that was made by the applicant. In re Raynes, 7 F.3d 1037, 1039, 28 USPQ2d 1630, 1631 (Fed.Cir.1993); In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1445 (Fed.Cir.1992). Obviousness can not be established by hindsight combination to produce the claimed invention. In re Gorman, 933 F.2d 982, 986, 18 USPQ2d 1885, 1888 (Fed.Cir.1991). As discussed in Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1143, 227 USPQ 543, 551 (Fed.Cir.1985), it is the prior art itself, and not the applicant's achievement, that must establish the obviousness of the combination.

The teachings of the references, their relatedness to the field of the applicant's endeavor, and the knowledge of persons of ordinary skill in...

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