UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD. Ex parte STEPHEN W. BOYD

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2 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEPHEN W. BOYD Appeal Application 1 10/625,145 Technology Center 3700 Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and ULRIKE W. JENKS, Administrative Patent Judges. JENKS, Administrative Patent Judge DECISION ON APPEAL This is an appeal under 35 U.S.C. 134 involving claims to a device for removing material from a vessel wall. The Examiner has rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. 6(b). We reverse. 1 Appellant identifies Tyco Healthcare Group LP as the Real Party in Interest (App. Br. 3).

3 STATEMENT OF THE CASE The Specification describes a material removing device using a cage that protects healthy tissue by limiting the amount of material which is removed. (Spec. 3, ll. 1-4.) [The] cage preferably forms 2-20 openings, more preferably 4-8 openings, which are spaced around the device. An advantage of the present invention is that the user does not need to rotate the device to orient a single cutting window.... The material extending into and through the openings is sheared by shearing surfaces on the cage and removal element. The material removing element preferably removes material around a significant portion of the cage but may also selectively remove material extending into the openings. (Spec. 2, ll ) In addition, the method can be used for removing neointimal tissue and other material from the inside of a previously deployed stent.... [The method] is particularly useful for this procedure since the cage prevents the material removing element from contacting the stent. (Spec. 3, ll ) The Specification also describes that the material removing element may be used a number of times before deploying the cage so that material may be removed at a number of vascular sites before the cage is deployed. (Spec. 11, ll ) Claims 16, 28-35, 63, and 64 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 16 is representative of the claims on appeal, and reads as follows (emphasis added): 16. A device for removing material from a vessel wall at a vascular site, comprising: a cage which is movable from a collapsed position to an expanded position, the cage having a plurality of openings in the expanded position, the openings being formed by rigidly connected elements, the cage being configured such that when the cage is in the expanded position at the vascular site material 2

4 from the vessel wall extends from the vessel wall into the openings, the cage having an inner surface which defines a cavity, the cage being releasable so that the cage may be left within the patient; and a material removing element positioned within the cage cavity to remove the material from the vessel wall extending into the openings when the cage is in the expanded position, the material removing element being positioned beneath the cage and being configured to be movable along the inner surface of the cage to remove the material extending into the openings. Claim 28, the only other independent claim, includes the additional limitation of a sheath being retractable relative to the cage to expose the cage and permit the cage to expand. The Examiner has rejected the claims as follows: I. claim 16 under 35 U.S.C. 102(e) as being anticipated by Passafaro; 2 II. claims 63 and 64 under 35 U.S.C. 103(a) as being obvious over Passafaro in view Reger; 3 III. claims and under 35 U.S.C. 103(a) as being obvious over Passafaro in view Klein; 4 and IV. claims 31 and 32 under 35 U.S.C. 103(a) as being obvious over Passafaro in view Klein and further in view of Reger. I-II. Rejections based on Passafaro alone or in combination with Reger The Examiner takes the position that Passafaro disclosed: 2 James D. Passafaro et al., US 6,156,046, issued Dec. 5, Vincent A. Reger et al., US 5,211,651, issued May 18, Enrique J. Klein et al. US 5,776,141, issued July 7,

5 (Ans. 4-5.) a cage (a stent S, as best seen in figures 10I-M) which is movable from a collapsed position to an expanded position, the cage having a plurality of openings (see figures 10I-K)... the cage S having an inner surface which defines a cavity, the cage being releasable so that the cage may be left within the patient; and a material removing element 54 positioned within the cage cavity to remove the material from the vessel wall extending into the openings when the cage is in the expanded position, the material removing element being 54 positioned beneath the cage as best seen in figures 10I-J and being configured to be movable along the inner surface of the cage to remove the material extending into the openings. Does the preponderance of the evidence of record support the Examiner s finding that Passafaro disclosed the recited device? Findings of Fact FF 1. Passafaro disclosed that Fig. 10A-M illustrate the use of the system 30 in connection with a blood vessel BV that has been partially occluded by occluding material OM at the region where a stent S had previously been implanted, the system 30 can also be used with a non-stented blood vessel BV that has been partially occluded (i.e., stenosed) by occluding material OM. (Passafaro col. 20, ll. 7-13; Ans. 4.) FF 2. Passafaro disclosed a system for removing occluding material from a lumen. 4

6 Passafaro s Fig 10 I, reproduced above, shows occluding material (OM) in a blood vessel (BV) at a region were a stent (S)) had previously been implanted. (Passafaro col ; Ans. 4.) FF 3. Passafaro explains that [t]he removal mechanism 54 followss the helical path of the helical guide section 200 as it is guided therealong. However, the portions of the helical guide sectionn 200 that are proximal to the removal mechanism 54 become straightened..... When the distal end 38 of the catheter 32 reachess the distal-most extent of the occluding material OM, a helical channel HC of occluding material OM will have been removed. (Passafaro col. 22, ll ; Ans. 4.) FF 4. Reger disclosed the a catheter artherotome with the use of a filter 262 in the form of a stocking-like generally tubular filter membrane 264 of an appropriate material such as woven polyester fabric defining suitably small openings, i.e., opening which are small enough not to permit passage off particles large enough to obstructt smaller arteries or capillaries. (Reger col. 14,ll ; Ans. 5.) Analysis Appellant contends that the claimed device comprises both (1) an expandable cage, and (2) a material removingg element positioned within a cavity defined by an inner surface of the cage. (App. Br. 6.) [T]he system which is disclosed by Passafaro does not include 5

7 the stent which is described as having been previously implanted, nor does it include any other structure which could be considered to comprise a cage. The stent merely forms a part of the environment in which the system disclosed by Passafaro may be used. (App. Br. 7.) [T]he device indentified [sic] by the Examiner as anticipating claim 16 comprises a stent left at the treatment site during a first treatment procedure and the removal mechanism of Passafaro s device which is used during a second treatment procedure to remove material from within the stent. (App. Br. 8) The Examiner takes the position that [a]lthough, the system disclosed by Passafaro is for removing stenotic material from blood vessel in which a stent has been previously implanted..., Passafaro discloses in figs. 10I-M, a stent S is equivalent as a cage and a material removal element 54 is positioned within the cage cavity. Thus, these two distinct devices are capable of being used together in this one device of Passafaro s system for guided atherectomy. In this case, Passafaro s system, figures, 10I-M, stent S has the feature of the cage and function similar as recited in claim [in that it] holds the vessel open in much the same manner as a stent. (Ans. 8-9 (emphasis omitted).) We agree with Appellant s position that the claims are directed to a device comprising a cage and a material removing element. Although the open claim language, of a device... comprising, allows for the inclusion of additional elements, the device minimally requires a cage and a material removing element. The Examiner takes the position that the following claim limitations are functional and/or intended use limitations: (1) moveable from a collapsed position to an expanded position and that the cage be (2) releasable so that the cage may be left within the patient that do not impart any structure 6

8 limitation into the device which is capable of being used as claimed if one desires to do so. (Ans. 9.) We do not agree with the Examiner s interpretation that these limitations are solely functional. The collapsed or expanded form of a stent provides a description that imparts structural information about the stent shape. In addition, the limitation that the cage is releasable from the device implies that there is a connection with the device before the cage can be let go from the device. Thus, we agree with the Appellant s position that the device as claimed requires a cage and a tissue removal element. We agree with the Examiner s position that Passafaro shows a tissue removing element that can be used in a previously stented blocked blood vessel (Ans. 8). Passafaro also disclosed that the same tissue removing element can be used in a vessel that is not stented (FFs 1-3). The Examiner looks to the Specification to establish that the cage can function in much the same way as a stent. The Examiner then concludes that the previously deployed stent disclosed in Passafaro meets the claim limitation of an expandable cage, that functions similar to the cage recited in claim 16 (Ans. 8-9). We agree with the Examiner that the previously placed stent meets the limitation of a cage, what is missing in the Answer is an identification of the structure that the Examiner considers to be the device that provides the cage in conjunction with the material removing element as required by the claim. To anticipate, every element and limitation of the claimed invention must be found in a single prior art reference, arranged as in the claim. Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). Although we recognize that the claim provides that the cage may be left in a patient, the device, never the less, still requires that the cage and 7

9 tissue removal device be connected in some way so that the cage may be released from the device. Passafaro disclosed a method of removing occluding material from a previously stented blood vessel using a tissue removal device (FFs 1-3). The Examiner has not pointed to any persuasive evidence that the device used to place the stent is the same as the device that is used to introduce the tissue removing element. We do not agree with the Examiner s position that two distinct devices that are capable of being used together sequentially anticipates a claim that is directed at a device that comprises, at least for a period of time, the presence of both a stent (i.e. cage) and a tissue removal element. In sum, as we are not persuaded, for the reasons discussed, that the Examiner has adequately explained how or Passafaro s system describes, within the meaning of 35 U.S.C. 102, a device having the features required by claim 16, we reverse the Examiner s anticipation rejection of this claim. Claims 63 and 64, recite the additional limitation of a bag coupled to the material removing element. The Examiner looks to Reger to provide the limitation of a bag attached to a tissue removal element (FF 4). This rejection relies on the underlying anticipation rejection of claim 16 over Passafaro. Having reversed the rejection of claim 16, we necessarily reverse this obviousness rejection over claims 63 and 64 including a collapsible bag attached to the tissue removing device because Reger does not cure the deficiency of Passafaro s device. II. The Issue: Rejections based on Passafaro and Klein The Examiner takes the position that Passafaro disclosed all elements of the claim 8

10 but fails to disclose an expandable cage being contained within a sheathh and the sheath is retractablee relative to the cage to expose or expand the cage. However, Klein et al teach an expandable cage S being contained within a sheath 70 and the sheath 70 is retractable relative to the cage to expose or expand the cage.... [I]t would have beenn obvious to one having ordinary skill in the art at the time the invention was made to modify the devicee of Passafaro with an expandable cage being contained within a sheath and the sheath is retractable relative to the cage to expose or expand the cage in order to deliver a proper stent to intraluminal target sites. (Ans. 10.) Does the preponderance of the evidence of record support the Examiner s conclusion that the combination of Passafaro and Klein meets the claim limitation of a device comprising a sheath, a cage, and a material removing element? Additional Findings of Fact FF 5. Klein disclosed employing an evertible sheath for covering a prosthesis prior to balloon deployment. (Klein col. 6, ll ) Fig 10, reproduced d above, shows: A delivery catheter 12 employing an evertible sheath 70 stent as the stentt retaining structure is illustrated in FIGS. 10 and 11. The evertible sheath 70 is attached too the catheter body 16 at location 71 folded over into an inner layer 72 and an outer layer 74. Initially, a distal fold 76 on the sheath 70 is constrained 9

11 within an annular retainer 78 which radially constrains the end over distal end of the catheter body and the stentt S. A pullwire 80 is attached to the proximal end of the outer layer 74 of the sheath 70. (Klein col. 11, ll ; Ans. 6.) FF 6. Fig. 11 of Klein, reproduced below shows a pullwire 80 [that] may be proximally withdrawn to pull back the sheath 70 as illustrated in FIG. 11. After the stent S has been uncovered it may be deployedd by the internal balloon catheter 14 as described previously and illustrated in broken line in FIG. 11. (Klein col. 11, ll ) Analysis There are two obviousness rejections that are based, in whole or part, on the combination of Passafaro and Klein. As the same issue is dispositive for both rejections we will discuss them together (see App. Br. 12). Appellant contends that a person of skill in the art would have no reason to intentionally incorporate a stentt into the system disclosed by Passafaro.... no reason to combine a stent delivery catheter with a device to remove occluding material from an implanted stent since the person of skill in the art understands that a stent becomes occluded, if at all, only after the passage of time so there would be no reason to include a material removal device at the time the stentt is initially implanted. (App. Br. 11) 10

12 The Examiner contends that Passafaro disclosed a cage that was movable from a collapsed position to an expanded position, the cage having a plurality of openings (Ans. 9). The Examiner acknowledges that Passafaro fails to disclose an expandable cage being contained within a sheath.... Klein et al teach an expandable cage S being contained within a sheath 70 and the sheath 70 is retractable relative to the cage to expose or expand the cage (Ans. 10). We find that the Appellant has a better position. The Examiner relies on Klein for the teaching of a sheath, concluding that it would have been obvious to modify the device of Passafaro with an expandable cage being contained within a sheath and the sheath is retractable relative to the cage to expose or expand the cage in order to deliver a proper stent to intraluminal target sites (Ans. 6). The proposed modification by the Examiner is to include a sheath with the device of Passafaro, thus, the Examiner s rejection is premised on the prior finding that Passafaro disclosed a device that contains a cage and a tissue removing element (see above I.-II.). As discussed above (I.-II.), we do not agree with the Examiner s finding that Passafaro disclosed such a device. Consequently, we do not agree with the Examiner s conclusion that the combination of Klein s sheath with Passafaro s device meets all the recited claim limitations. [O]bviousness requires a suggestion of all limitations in a claim. CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003). As the Examiner has failed to adequately articulate any other rationale explaining how the combination of Passafaro and Klein discloses a device comprising a cage, sheath, and tissue removal element, we are constrained to reverse each rejection that relies on Passafaro and Klein. 11

13 SUMMARY We reverse the rejection of claim 16 under 35 U.S.C. 102(e) as being anticipated by Passafaro. We reverse the rejection of claims 63 and 64 under 35 U.S.C. 103(a) as being obvious over Passafaro in view Reger. We reverse the rejection of claims and under 35 U.S.C. 103(a) as being obvious over Passafaro in view Klein. We reverse the rejection of claims 31 and 32 under 35 U.S.C. 103(a) as being obvious over Passafaro in view Klein and further in view of Reger. REVERSED lp 12

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