Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Objections of record regarding the drawings have been withdrawn
Objections of record regarding the claims have been withdrawn
Applicant’s arguments with respect to claim(s) 1 and 9 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.
Regarding claim 13, the applicant argues the longitudinal breaking is not taught, the examiner disagrees, see rejection below.
Claim Rejections - 35 USC § 103
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.
Claim Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Fukuoka (US 20150265802 A1) and Takagi (US 9656042 B2).
Regarding claim 1, Fukuoka teaches a catheter (abstract), comprising: a first region (element 75, fig 5) having a first outer diameter (see diameter of element 75, fig 5); a second region (element 71, fig 5) having a second outer diameter larger than the first outer diameter (see diameter of element 71, fig 5); and a transition region connecting with the first region and the second region (see element 74, part of catheter between 75 and 71 in fig 5), the transition region having an outer diameter being equal to or larger than the first outer diameter and equal to or smaller than the second outer diameter (see diameter transition in fig 5, [0065]), and wherein the transition portion has a plurality of protrusions (elements 77 in fig 5).
Fukuoka does not exactly disclose the details of gradually increasing apex of a protrusion. Takagi teaches a catheter (see entire document) with a transition region (for example see annotated fig 19a) that has a protrusion (see annotated fig 19a), and a distance from a central axis of the first region to an apex of the protrusion gradually increases from the first region toward the second region (see annotated fig 19a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the protrusion as taught by Fukuoka by including the gradual change in apex distance, as taught by the protrusion in Takagi, because it would be obvious to try choosing from a finite number of identified protrusion shapes in the art, with a reasonable expectation of successful implant delivery; (MPEP 2143).
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Annotated figure 19a
Regarding claim 2, Fukuoka further teaches wherein a recess portion (the portion at the end of element 81 is recessed) formed on the outer circumferential surface of the transition region (the portion is on the outer surface of element 74, fig 6), and a diameter-direction dimension of the recess portion is smaller than the second outer diameter (see fig 5, recessed portion is smaller than element 71 diameter).
Regarding claim 3, Fukuoka further teaches wherein the recess portion is positioned between the adjacent protrusions (see orientation in fig 5, concavities are between each protrusion).
Regarding claim 4, Fukuoka further teaches wherein the plurality of protrusions are arranged in a circumferential direction of the catheter ([0064], fig 5) at equal intervals therebetween ([0064], [0077], fig 5).
Regarding claim 5, Fukuoka further teaches a pipe (lumen 76, [0086]) arranged coaxially with respect to the catheter by being embedded in the second region ([0086] lumen embedded in inner catheter shell); and a wire connected with the pipe (guide wire 150, [0086]).
Regarding claim 6, Fukuoka further teaches wherein the recessed portion (the portion at the end of element 81 is recessed, fig 5-6) is formed in a concave shape (recessed portion is concave and further has concavities 78, fig 6) in the circumferential direction of the transition region (the entire recess is in the circumferential direction).
Regarding claim 7, Fukuoka further teaches wherein the recessed portion is formed in a proximal end of the transition region (recess is at proximal region of element 74, fig 5-6) along a longitudinal direction of the transition region (the recess is formed along a longitudinal direction, see orientation in fig 5-6).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fukuoka (US 20150265802 A1) and Takagi (US 9656042 B2), and further in view of Matlock (US 20190060623 A1) and Irwin (US 20110144581 A1).
Regarding claim 8, Fukuoka teaches a transition region capable of breaking (structure is capable of this). Fukuoka does not teach wherein a breaking strength of the transition region along a longitudinal direction of the transition region is in a range from 45N to 80N. Matlock teaches a breakaway catheter (abstract) wherein breaking occurs ([0058]- [0059]) along a longitudinal direction ([0059 “longitudinally separated upon application of a predetermined force”) of the transition region (element 114, fig 4-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Fukuoka by including the longitudinal breaking, as taught by Matlock, in order to allow for various exit angles for removing the delivery device ([0047]).
Fukuoka in view of Matlock does not exactly teach wherein the breaking strength is within a range from 45N to 80N. Irwin teaches about catheters ([0008]) that are typically subjected to 15-30N of force. Therefore, a breaking strength in a catheter would have to be greater than 15-30N in force to avoid accidental breaking. A breaking strength in the range of 45N to 80N would optimize parameters to allow intentional breaking and avoid accidental breaking. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the force teachings of Irwin to the device taught by Fukuoka in view of Matlock, in order to optimize parameters, to allow intentional breaking for forces that exceed 30N and avoid accidental breaking of forces under 30N. Further routine optimization only requires ordinary skill in the art (MPEP 2144.05 (II)).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fukuoka (US 20150265802 A1) and Takagi (US 9656042 B2), and in further view of Seeman (EP 1872749 A1) and Hartley (US 10201414 B2).
Regarding claim 9, Fukuoka teaches a delivery catheter (abstract) including: a first region (element 75, fig 5) having a first outer diameter (see diameter of element 75, fig 5) diameter; a second region (element 71, fig 5) having a second outer diameter larger than the first outer diameter (see diameter of element 71, fig 5); and a transition region connecting with the first region and the second region (see element 74 and connection between element 75 and 71 in fig 5), the transition region having an outer diameter being equal to or larger than the first outer diameter and equal to or smaller than the second outer diameter (see diameter transition in fig 5, [0065]), wherein the outer diameter of the transition region gradually decreases from the second region toward the first region (see element 74 in fig 5, [0065]), and part of an outer circumferential surface of the transition region is formed in a shape having a step portion (see step at element 81 in fig 6).
Fukuoka does not exactly disclose wherein the stent delivery device includes tubular stent, and guide tube. Seemann teaches a stent delivery device (abstract) comprising a delivery catheter including a tubular stent and a guide tube inserted into the stent ([0018]) at least a portion of the first region would protrude from a distal end of the tubular stent (for example during delivery);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Fukuoka, by including stent delivery components, as taught by Seeman, in order to deliver a stent into a hollow region of the body (field of invention).
Fukuoka in view of Seemann does not exactly disclose wherein the step portion positioning however Hartley teaches a stent that is positioned external to the entirety of a guide catheter (figure 8/9, stent 70 external to catheter 5), the step portion as taught by the combination above would be surrounded by an external stent, the step portion would be between the stent end and second region.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Fukuoka and Seeman, by including stent placement, as taught by Seeman, because it would be obvious to try choosing from a finite number of stent placements with reasonable expectation of success (MPEP 2143).
Regarding claim 10, Fukuoka further teaches wherein the step portion is a recess portion (the step portion at the end of element 81 is recessed) formed on the outer circumferential surface of the transition region (the step portion is on the outer surface of element 74, fig 6), and a diameter-direction dimension of the recess portion is smaller than the second outer diameter (see fig 5, recessed portion is smaller than element 71 diameter).
Regarding claim 11, Fukuoka further teaches wherein the transition region has a plurality of protrusions (elements 77 in fig 5), and the recess portion is positioned between the plurality of protrusions (see orientation in fig 5, concavities are between each protrusion).
Regarding claim 12, Fukuoka further teaches wherein the plurality of protrusions are arranged in a circumferential direction of the catheter ([0064], fig 5) at equal intervals therebetween [0064], [0077], fig 5).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Fukuoka (US 20150265802 A1) and Takagi (US 9656042 B2 in view further of Seeman (EP 1872749 A1), Matlock (US 20190060623 A1), and Irwin (US 20110144581 A1).
Regarding claim 13, Fukuoka teaches a delivery catheter (abstract) including: a first region (element 75, fig 5) having a first outer diameter (see diameter of element 75, fig 5); a second region (element 71, fig 5) having a second outer diameter larger than the first outer diameter (see diameter of element 71, fig 5); and a transition region connecting with the first region and the second region (see element 74 and connection between 71 and 75 in fig 5), the transition region having an outer diameter being equal to or larger than the first outer diameter and equal to or smaller than the second outer diameter (see diameter transition in fig 5, [0065]), and the transition region and the first region are configured such that breaking occurs in the transition region (structure is capable of breaking in the transition region).
Fukuoka does not exactly disclose wherein the stent delivery device includes tubular stent, and guide tube. Seemann teaches a stent delivery device (abstract) comprising a delivery catheter including a tubular stent and a guide tube inserted into the stent ([0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Fukuoka, by including stent delivery components, as taught by Seeman, in order to deliver a stent into a hollow region of the body (field of invention).
Fukuoka in view of Seeman does not teach wherein a breaking strength of the transition region along a longitudinal direction of the transition region is in a range from 45N to 80N. Matlock teaches a breakaway catheter (abstract) wherein breaking occurs ([0058]- [0059]) along a longitudinal direction ([0059], “longitudinally separated upon application of a predetermined force”) of the transition region (element 114, fig 4-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Fukuoka in view of Seeman by including the longitudinal breaking, as taught by Matlock, in order to allow for various exit angles for removing the delivery device ([0047]).
Fukuoka in view of Seeman and Matlock does not teach wherein the breaking strength is within a range from 45N to 80N. Irwin teaches about catheters ([0008]) that are typically subjected to 15-30N of force. Therefore, a breaking strength in a catheter would have to be greater than 15-30N in force to avoid accidental breaking. A breaking strength in the range of 45N to 80N would optimize parameters to allow intentional breaking and avoid accidental breaking. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the force teachings of Irwin to the device taught by Fukuoka in view of Matlock, in order to optimize parameters, to allow intentional breaking for forces that exceed 30N and avoid accidental breaking of forces under 30N. Further routine optimization only requires ordinary skill in the art (MPEP 2144.05 (II)).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/H.L.P./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774