DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 9-15, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macoviak et al. (US 6,361,545 B1).
Regarding claim 1, Macoviak discloses a large bore catheter (Fig. 8) comprising: a longitudinal axis (i.e., along 134); an elongate body 134 comprising a lumen (i.e., as shown in Figs. 7-7A), a proximal end, and a distal end (Figs. 7-8A); and a support frame at the distal end of the elongate body (Fig. 8) having a proximal end, a distal end (Fig. 8), a collapsed delivery configuration (Figs. 7-7A) and an expanded deployed configuration (Figs. 8-8A), the support frame comprising a framework of struts (Fig. 8 shows 140 which has a plurality of struts making up a framework), the framework of struts comprising one or more hoop segments 136 and at least two axial rows of a plurality of deformable closed cells (Fig. 8A) configured to assume an axially extended profile when the support frame is in the collapsed delivery configuration (Figs. 7-7A) and expand to a radially extended profile when the support frame is in the expanded deployed configuration (Figs. 8-8A), the support frame further comprising an open mouth at the distal end of the support frame (Fig. 8) configured to expand from a first diameter in the collapsed delivery configuration (Fig. 7) to a second larger diameter in the expanded deployed configuration (Fig. 8); wherein the expanded deployed configuration of the support frame is sized to have a larger inner diameter than an inner diameter of an outer sheath (Fig. 8), wherein in the collapsed delivery configuration, the at least two axial rows of the plurality of deformable closed cells are parallel to the longitudinal axis (Fig. 7), and wherein in the collapsed delivery configuration, the one or more hoop segments extend circumferentially (i.e., at least since there are several 136 that extend around the framework as shown in Fig. 8) between the at least two axial rows of the plurality of deformable closed cells in a direction of a plane perpendicular to the longitudinal axis (i.e., see Fig. 8, 136 extends between the cells to the tube 134 and 138 such that it extends perpendicular to the longitudinal axis).
Regarding claim 2, Macoviak discloses the catheter of claim 1. Macoviak also discloses Macoviak also discloses wherein the struts of the plurality of deformable closed cells comprise an angle with the longitudinal axis of less than 30 degrees in the collapsed delivery configuration (Fig. 7).
Regarding claim 3, Macoviak discloses the catheter of claim 1. Macoviak also discloses wherein the struts of the plurality of deformable closed cells comprise an angle with the longitudinal axis of greater than 45 degrees in the expanded deployed configuration (Fig. 8).
Regarding claim 4, Macoviak discloses the catheter of claim 1. Macoviak also discloses wherein the at least two axial rows of the plurality of support cells are spaced 90 degrees or more apart (i.e., at least because the cells are around the circumference of 134 that at least two of the rows are spaced 90 degrees or more apart).
Regarding claim 5, Macoviak discloses the catheter of claim 1. Macoviak also discloses the support frame comprising two axial rows of the plurality of deformable closed cells that are spaced 180 degrees apart (at least because the cells are around the circumference of 134 that at least two of the rows are spaced 180 degrees apart).
Regarding claim 6, Macoviak discloses the catheter of claim 1. Macoviak also discloses wherein the plurality of deformable closed cells comprise less than 30% of a circumference of the support frame when the support frame is in the collapsed delivery configuration (Fig. 7).
Regarding claim 9, Macoviak discloses the catheter of claim 1. Macoviak also discloses wherein a difference between an inner diameter of the support frame in the expanded deployed configuration and an inner diameter of the support frame in the collapsed delivery configuration is more than 10% of the inner diameter in the collapsed delivery configuration (Figs. 7-8A).
Regarding claim 10, Macoviak discloses the catheter of claim 1. Macoviak also discloses wherein the one or more hoop segments account for a percentage of a circumference of the support frame, the percentage being greater in the collapsed delivery configuration than the percentage in the expanded deployed configuration (Figs. 7-8A).
Regarding claim 11, Macoviak discloses the catheter of claim 1. Macoviak also discloses wherein the struts of the plurality of deformable closed cells comprise a first arc length in the collapsed delivery configuration that is less than a second arc length in the expanded deployed configuration (i.e., at least the distal struts that expand outwardly in Fig. 8-8A).
Regarding claim 12, Macoviak discloses the catheter of claim 1. Macoviak also discloses the support frame further comprising one or more connecting spines 126/116 connecting the support frame with the elongate body.
Regarding claim 13, Macoviak discloses the catheter of claim 1. Macoviak also discloses the support frame further comprising a maximum outer diameter in the expanded deployed configuration that is less than an inner diameter of a target vessel at a treatment site (Fig. 24).
Regarding claim 14, Macoviak discloses the catheter of claim 1. Macoviak also discloses wherein the struts of the plurality of deformable closed cells form a cell angle with the longitudinal axis of greater than 70 degrees in the expanded deployed configuration (Fig. 8-8A).
Regarding claim 15, Macoviak discloses the catheter of claim 1. Macoviak also discloses wherein the struts of at least a portion of the support frame form a flare angle with the longitudinal axis (Fig. 8-8A), the flare angle configured to be approximately zero degrees in the collapsed delivery configuration (Figs. 7-7A) and approximately 90 degrees in the expanded deployed configuration (Figs. 8-8A).
Regarding claim 21, Macoviak discloses the catheter of claim 1. Macoviak also discloses wherein the plurality of deformable closed cells are connected by the hoop segments (i.e., indirectly via 126/116).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Macoviak.
Regarding claims 7 and 8, Macoviak discloses the catheter of claim 1. Macoviak does not directly disclose the support frame further comprising a longitudinal length sized to be less than three times an inner diameter of the elongate body; the support frame further comprising an inner diameter of approximately 0.070 inches in the collapsed delivery configuration and a maximum inner diameter in a range of approximately 0.080-0.120 inches in the expanded deployed configuration.
Macoviak does disclose that in the collapsed position, the device is sheathed in a delivery device 134 and as such the diameter and length need to be optimized to be easily deployed by the delivery device. As seen in Fig. 7-8A, the device must also be expanded to substantially larger than the delivery device and each segment of 140 must be deployed such that the diameter and the length are disclosed to be a result effective variable in that changing the length and diameter of the device changes how easily the device may be delivered through the delivery device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Macoviak device to have the required length and diameter, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Macoviak by making the longitudinal length sized to be less than three times an inner diameter of the elongate body, the support frame further comprising an inner diameter of approximately 0.070 inches in the collapsed delivery configuration and a maximum inner diameter in a range of approximately 0.080-0.120 inches in the expanded deployed configuration as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15, 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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