DETAILED ACTION
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 Amendment
The amendment filed 02/25/2026 has been entered. Claims 1-20 remain pending in the application and claims 18-20 are withdrawn. Applicant’s amendments to the claims have overcome the interpretation of the rejection previously set forth in the Non-Final Office Action mailed 11/26/2025, however Nicholson is still applied to disclose the amended features in a related embodiment (see rejection below).
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
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 1-8 and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nicholson et al. (US PGPub 2022/0211397) in view of McConnell et al. (US PGPub 2021/0085924), hereinafter known as “Nicholson” and “McConnell,” respectively.
With regards to claim 1, Nicholson discloses (Figures 9-11E, 17 and 20) a delivery device 10 for an occlusive implant 180 (paragraph 112), the delivery device 10 comprising:
a delivery sheath 92 having a proximal region 96, a garage region 40, and a distal tip region (see annotated figure 10A below);
an inner tubular member 170 disposed within at least the proximal region and the garage region of the delivery sheath 92, the inner tubular member 170 defining a lumen 172 extending therethrough (figure 17; paragraph 106 – “the design may optionally incorporate an internal steerable guide sheath 170 between the guidewire and the catheter shaft”);
wherein the lumen in the proximal region 96 has a proximal inner diameter (see figures 9 and 10B-10E);
wherein the lumen in the garage region 40 has a garage inner diameter (see figures 9 and 11A-11E);
a reinforcing member extending along the proximal region 96, the garage region 40, or both (the interpretation of the reinforcing member changes when examining the dependent claims, for example, the reinforcing member may be interpreted as the braid layer 186 and coil layer 188 (paragraphs 79-80), or may be interpreted as the series of links 106/118 and frames 100/112 (paragraphs 80-81)); and
an occlusive implant 180 releasably coupled (figure 20; paragraph 112).
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Nicholson further discloses in paragraph 111 that “one or two or more lumen extending through the catheter may also be configured to be compatible with a variety of commonly used tools for CTO crossing procedures, including… drilling microcatheters to gain access to the subintimal space; dilation balloon catheters.” Although Nicholson does not explicitly disclose a core member releasably coupled to the occlusive implant, Nicholson does disclose a member (drilling catheter, dilation balloon catheter) extending through the lumen of the catheter, or the inner tubular member.
Nicholson is silent wherein the lumen in the garage region has the garage inner diameter larger than the proximal inner diameter;
a core member slidably disposed within the lumen of the inner tubular member; and
the occlusive implant releasably coupled to the core member.
However, in a similar field of endeavor of delivering implants, McConnell teaches (Figures 1-3 and 8-11) wherein the lumen in the garage region 132 has the garage inner diameter larger than the proximal inner diameter (proximal inner diameter of 128; figures 2-3; paragraphs 89, 92, and 108);
a core member 102 slidably disposed within the lumen of the inner tubular member 108 (paragraphs 83-84); and
the occlusive implant 104 releasably coupled to the core member 102 (paragraph 84).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Nicholson to include wherein the lumen in the garage region has the garage inner diameter larger than the proximal inner diameter as taught by McConnell for the purpose of facilitating positioning of the drilling catheter and creating a friction lock (paragraph 108 of McConnell).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Nicholson to include a core member slidably disposed within the lumen of the inner tubular member; and the occlusive implant releasably coupled to the core member as taught by McConnell for the purpose of controllably releasing the implant.
With regards to claim 2, Nicholson further discloses wherein the proximal region 96 has a proximal outer diameter and wherein the garage region 40 has a garage outer diameter that is substantially equal to the proximal outer diameter (see figures 9 and 10A, outer diameter is constant throughout the sheath 92 up until the taper just proximal of the distal tip region, see annotated figure 10A above).
With regards to claim 3, Nicholson further discloses wherein the proximal region 96 has a proximal outer diameter and wherein the garage region 40 has a garage outer diameter that is different from the proximal outer diameter (see distal end of the garage region 40 where the outer diameter tapers, this diameter is different than the outer diameter of the proximal region, paragraph 118).
With regards to claim 4, Nicholson further discloses wherein the reinforcing member 186 includes a braid (paragraphs 79-80; figures 10B-10C).
With regards to claim 5, Nicholson further discloses wherein the reinforcing member 106/118/100/112 includes a tubular member 100/112 having a plurality of slots 104A/104B/116A formed therein (figures 11A-11C; paragraphs 80-81).
With regards to claim 6, Nicholson discloses wherein the reinforcing member 106/118/100/112 extends along the garage region 40 (figure 10A).
With regards to claim 7, Nicholson further discloses wherein the proximal region 96 is free of the reinforcing member 106/118/100/112 (figures 10A and 11A-11D).
With regards to claim 8, Nicholson further discloses wherein the reinforcing member 106/118/100/112 is disposed along the garage region 40 (figure 10A) and wherein the proximal region 96 further comprises a reinforcing braid 186 (paragraphs 79-80; figures 10B-10C).
With regards to claim 10, as rejected above, it would be obvious to modify the delivery device of Nicholson to include the core member and the proximal inner diameter of the proximal region as taught by McConnell. McConnell further discloses wherein the core member 102 has an outer diameter that is within 0.01 inches or less of the proximal inner diameter (see figures 9-11 where the core member 102 is frictionally fitted through the proximal end 122 of the inner tubular member 108; paragraph 92 discloses “the configuration of the locking element 108 may be adjusted to create the desired effect. For example, one or more of the inner diameters 137, 138 may be made larger or smaller to accommodate different sizes of sheaths 106 and/or different outer diameters of the pusher wire 102… the outer diameter of the locking element 108 may be increased or decreased to facilitate handling”). Thus, when incorporating the core member and the proximal inner diameter of the proximal region of McConnell, the claimed limitation is considered obvious.
With regards to claim 11, Nicholson discloses (Figures 9-11E and 20) a delivery device 10 for an occlusive implant 180 (paragraph 112), the delivery device 10 comprising:
a delivery sheath 92 having a proximal region 96, a garage region 40 disposed distally of the proximal region 96, and a distal tip region disposed distally of the garage region 40 (see annotated figure 10A below);
an inner tubular member 170 disposed within at least the proximal region and the garage region of the delivery sheath 92, the inner tubular member 170 defining a lumen 172 extending therethrough (figure 17; paragraph 106 – “the design may optionally incorporate an internal steerable guide sheath 170 between the guidewire and the catheter shaft”);
wherein the lumen in the proximal region 96 has a proximal inner diameter (see figures 9 and 10B-10E);
wherein the lumen in the garage region 40 has a garage inner diameter (see figures 9 and 11A-11E);
a garage reinforcing member (the series of links 106/118 and frames 100/112; paragraphs 80-81) disposed along the garage region 40; and
a proximal reinforcing member (the braid layer 186 and coil layer 188; paragraphs 79-80) disposed along the proximal region 96.
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Nicholson further discloses in paragraph 111 that “one or two or more lumen extending through the catheter may also be configured to be compatible with a variety of commonly used tools for CTO crossing procedures, including… drilling microcatheters to gain access to the subintimal space; dilation balloon catheters.” Although Nicholson does not explicitly disclose a core member releasably coupled to the occlusive implant, Nicholson does disclose a member (drilling catheter, dilation balloon catheter) extending through the lumen of the catheter, or the inner tubular member.
Nicholson is silent wherein the lumen in the garage region has a garage inner diameter larger than the proximal inner diameter.
However, in a similar field of endeavor of delivering implants, McConnell teaches (Figures 1-3 and 8-11) wherein the lumen in the garage region 132 has a garage inner diameter larger than the proximal inner diameter (proximal inner diameter of 128; figures 2-3; paragraphs 89, 92, and 108).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Nicholson to include wherein the lumen in the garage region has the garage inner diameter larger than the proximal inner diameter as taught by McConnell for the purpose of facilitating positioning of the drilling catheter and creating a friction lock (paragraph 108 of McConnell).
With regards to claim 12, Nicholson further discloses wherein the proximal region 96 has a proximal outer diameter and wherein the garage region 40 has a garage outer diameter that is substantially equal to the proximal outer diameter (see figures 9 and 10A, outer diameter is constant throughout the sheath 92 up until the taper just proximal of the distal tip region, see annotated figure 10A above).
With regards to claim 13, Nicholson further discloses wherein the proximal region 96 has a proximal outer diameter and wherein the garage region 40 has a garage outer diameter that is different from the proximal outer diameter (see distal end of the garage region 40 where the outer diameter tapers, this diameter is different than the outer diameter of the proximal region, paragraph 118).
With regards to claim 14, Nicholson discloses wherein the proximal reinforcing member 96 includes a braid 186 (paragraphs 79-80).
With regards to claim 15, Nicholson discloses wherein the garage reinforcing member 106/118/100/112 includes a tubular member 100/112 having a plurality of slots 104A/104B/116A formed therein (figures 11A-11C; paragraphs 80-81).
With regards to claim 16, Nicholson further discloses wherein the proximal reinforcing member 186/188 is continuous with the garage reinforcing member 106/118/100/112 (paragraph 79 – “The braid 186 overlaps the proximal end of the support 92” and the proximal end of the support 92 is continuous with the garage reinforcing member as seen in figures 11A-11E).
With regards to claim 17, Nicholson/McConnel disclose the delivery device as claimed in claim 11. The combination is silent to further comprising a core member slidably disposed within the lumen of the inner tubular member and an occlusive implant releasably coupled to the core member.
However, in a similar field of endeavor of delivering an occlusive implant, McConnell teaches (Figures 1-3 and 8-11) a core member 102 slidably disposed within the lumen of the inner tubular member 108 (paragraphs 83-84) and an occlusive implant 104 releasably coupled to the core member 102 (paragraph 84).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Nicholson to include a core member slidably disposed within the lumen of the inner tubular member and an occlusive implant releasably coupled to the core member as taught by McConnell for the purpose of controllably releasing the implant.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nicholson in view of McConnell, and further in view of Haasl et al. (US PGPub 2016/0114156), hereinafter known as “Haasl.”
With regards to claim 9, Nicholson/McConnell disclose the delivery device as claimed in claim 1. The combination is silent wherein the distal tip region has a plurality of axial slits formed therein.
However, in a similar field of endeavor of delivering implants, Haasl teaches (Figures 7A-7B) wherein the distal tip region 547 has a plurality of axial slits 549 formed therein (paragraph 109 – “the apertures or cuts 549 may have a generally rectangular shape with the major length of the rectangle extending generally parallel to a longitudinal axis of the proximal section 140”; paragraph 111 – “portions closer to the distal tip 547 may include a greater density of apertures or cuts 549”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Nicholson/McConnell to include wherein the distal tip region has a plurality of axial slits formed therein as taught by Haasl for the purpose of providing a greater degree of lateral flexibility relative to the proximal regions (paragraph 111 of Haasl).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 04/28/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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