DETAILED ACTION
This action is in response to applicant's amendments filed 12/11/25.
The examiner acknowledges the amendments to the claims.
Claims 1-20 are pending in this application.
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
In light of Applicant’s amendments to claim 1, the rejection of claims 1-8 has been withdrawn.
Applicant’s arguments with respect to claim(s) 9-13 have been considered but are moot in view of the new grounds of rejection set forth below, including newly cited reference Schmitt et al., hereinafter “Schmitt” (U.S. Pub. No. 2011/0251666).
Applicant’s arguments with respect to claim(s) 14-20 have been considered but are moot in view of the new grounds of rejection set forth below.
Claim Objections
Claim 9 is objected to because of the following informalities: in line 10 it reads “a sleeve has a proximal end” and should rather read as --a sleeve having a proximal end--. Appropriate correction is required.
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 9-10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmitt (U.S. Pub. No. 2011/0251666).
Regarding claim 9, Schmitt discloses a method for delivering an endovascular graft within a blood vessel (Figures 5A-5B; [0025], [0096], [0100]; stent or stent graft may be deployed in tortuous vessels), the method comprising:
positioning a delivery system 500 having a tip assembly (including tapered tip 502 and stent retaining sleeve 512) and a tip capture mechanism (including spindle body 522, spindle pins 524, and landing component 532) holding the endovascular graft in a radially compressed configuration at a deployment location within a blood vessel ([0118]; stent graft is constrained by retaining sleeve 512);
moving the tip assembly relative to the tip capture mechanism to release the endovascular graft into a release position to affix the endovascular graft into the blood vessel ([0082]; sleeve 512 is moved in distal direction to deploy the stent graft); and
withdrawing the delivery system from the blood vessel without advancing the tip assembly and the tip capture mechanism beyond the deployment location ([0119]; after the sleeve 512 is moved distally to deploy a stent, the tapered tip and sleeve are not moved distally any further such that the sleeve remains centered and in an atraumatic profile for retraction from the patient);
the tip assembly includes a tip (tapered tip 502) and a sleeve stent (retaining sleeve 512) having a proximal end, the tip capture mechanism including a landing zone 538B (Figure 5B; [0118]-[0119]) having a proximal end and a distal end and edgelessly continuously extending between the proximal end and the distal end (Id.), and the proximal end of the sleeve and the landing zone of the tip capture mechanism align with each other after the moving step (Id.).
Regarding claim 10, Schmitt discloses the landing zone 538B of the tip capture mechanism smoothly, continuously extends between the proximal end and the distal end (Id.).
Regarding claim 13, Schmitt discloses the tip assembly and the tip capture mechanism form a continuous outer surface or contour in the release position (Figure 5B, [0119]; see tip sleeve 512 and landing collar 536 that form continuous outer surface or contour such that it provides an atraumatic profile and a relatively smooth transition that does not snag on the deployed stent when the delivery system is withdrawn from the patient).
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt (U.S. Pub. No. 2011/0251666) in view of Roeder et al., hereinafter “Roeder” (U.S. Pub. No. 2007/0233222).
Regarding claim 11, Schmitt discloses the claimed invention, as discussed above, except for the delivery system includes a travel limiter and the tip capture mechanism includes an end plate, the moving step includes moving the tip assembly relative to the tip capture mechanism between a proximal position and a distal position, and the travel limiter contacts the end plate in the distal position, thereby preventing further moving of the tip assembly.
In the same field of art, namely delivery systems, Roeder teaches in Figures 1-2, [0041] a travel limiter 30 and a tip capture mechanism 42 including an end plate 55 and when moving a tip assembly 28/15 relative to the tip capture mechanism between a proximal position and a distal position, the travel limiter contacts the end plate in the distal position, thereby preventing further moving of the tip assembly (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Schmitt with a travel limiter and end plate as claimed, as taught by Roeder, in order to further ensure no further distal movement of the tip assembly in order to maintain a position in which the delivery system maintains an atraumatic profile for retraction from the patient (Schmitt; Figure 5B, [0119]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt (U.S. Pub. No. 2011/0251666) in view of Caselnova (U.S. Pub. No. 2012/0296407).
Regarding claim 12, Schmitt discloses the claimed invention, as discussed above, except for a handle assembly including a screw gear having a screw thread and a wheel having a wheel thread, the wheel configured to move from a retracted position to an advanced position through rotational movement between the screw thread and the wheel thread, the handle assembly further includes an inner member coupled to the wheel and the tip assembly such that the rotational movement of the wheel is translated to axial movement of the tip assembly.
In the same field of art, namely delivery systems, in Figures 1, 1B, 5-6, Caselnova teaches a handle assembly including a screw gear (region 24 having threading 25; [0019]) having a screw thread 25 (Id.) and a wheel 46 having a wheel thread 45 ([0023]), the wheel configured to move from a retracted position (Figure 1) to an advanced position (Figure 1B) through rotational movement between the screw thread and the wheel thread ([0023], [0029]), the handle assembly further includes an inner member 43 (Figure 6) coupled 46 to the wheel and a tip assembly 48/49 such that the rotational movement of the wheel is translated to axial movement of the tip assembly (Figures 1-1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schmitt with a handle assembly with a screw thread, wheel, and inner member as claimed, as taught by Caselnova, in order to allow a user to selectively control and actuate the tip assembly for precise graft stent positioning ([0005]; Caselnova).
Claims 14, 17, 18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt (U.S. Pub. No. 2011/0251666) in view of Melsheimer (U.S. Pub. No. 2012/0150272).
Regarding claim 14, Schmitt discloses a delivery system 500 (Figures 5A-5B) for delivering an endovascular graft within a blood vessel (0025], [0096], [0100]; stent or stent graft may be deployed in tortuous vessels), the delivery system comprising:
a tip assembly including a tip 502 and a sleeve 512 having an inner surface (Id.); and
a tip capture mechanism (including spindle body 522, spindle pins 524, and landing component 532), the tip assembly configured to move axially relative to the tip capture mechanism ([0118]-[0119]) and between a delivery position (Figure 5A) and a release position (Figure 5B), the tip capture mechanism includes a cylindrical outer surface (522 has a cylindrical outer surface; [0108]) and knobs 524 arranged around the cylindrical outer surface, each knob having a rounded apex (similar to rounded pins 124 in Figure 2A, [0055]) and the knobs and inner surface of the sleeve configured to cooperate to hold a portion of the endovascular graft when the tip capture mechanism and the tip assembly are in the delivery position (Figure 5A; [0111]).
However, Schmitt does not disclose that each knob has a pyramidal structure and a base having base edges, the base edges of the knobs and the proximal end and the distal end of the cylindrical outer surface bound smooth regions of the cylindrical outer surface.
In the same field of art, namely delivery systems, Melsheimer teaches in Figures 6A-6C and [0058] a tip capture mechanism including a cylindrical outer surface (outer surface of cylindrical hub 32) including a proximal end and a distal end and knobs 46 having a pyramidal structure and a base having base edges, the base edges of the knobs and the proximal end and the distal end of the cylindrical outer surface bound smooth regions 30 of the cylindrical outer surface (see annotated Figure 6B below showing an outline of the smooth regions). It is noted that the claim does not require that the cylindrical outer surface proximal and distal ends and the base edges of the knobs 46 bound regions that are entirely smooth, as seen by the partial protrusions 50, nor that along the entire circumference of the cylindrical outer surface the proximal and distal ends and the base edges of the knobs bound regions that are smooth, but merely requires that there are smooth regions, or some parts that are smooth.
FIGURE 6B OF MELSHEIMER
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It would have been obvious to one of ordinary skill before the effective filing date to modify the rounded knobs in Schmitt to have a pyramidal structure, base edges, and smooth regions as claimed, as taught by Melsheimer, since the wider base and inclined surfaces of the pyramidal knobs may be self-aligning with an endovascular graft, provide for less shearing and jamming compared to conventional delivery systems, and allow for smoother release while providing sufficient retention (Melsheimer, [0057]; similar to advantages of cone-shaped knob embodiment in Figures 5A-5C).
Regarding claim 17, Schmitt as modified teaches the cylindrical outer surface is an elongated cylindrical outer surface (522 has an elongated cylindrical outer surface; [0055]; Schmitt, Figures 5A-5B) extending along a longitudinal axis of the tip capture mechanism (including spindle body 522).
Regarding claim 18, Schmitt as modified teaches the knobs 46 are circumferentially, equally spaced around the elongated cylindrical outer surface (Melsheimer; Figures 6A-6B).
Regarding claim 20, Schmitt as modified teaches the knobs are limited smooth features (Schmitt; pins 524 are similar to rounded pins 124 in Figure 2A, [0055]) with angles that are less than or equal to 45 degrees (also see Melsheimer, [0057] who teaches taper angles of the knobs being less than 30 degrees, which allows smoother release of an implant while providing sufficient retention).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 14, 17, 18, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 12,023,267 in view of Schmitt (U.S. Pub. No. 2011/0251666) and Melsheimer (U.S. Pub. No. 2012/0150272). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements in the application claims are to be found in the patent claims, except for features that are merely obvious. As discussed above, Schmitt teaches a tip capture mechanism including knobs 524 arranged around the cylindrical outer surface, each knob having a rounded apex (similar to rounded pins 124 in Figure 2A, [0055]) and the knobs and inner surface of the sleeve configured to cooperate to hold a portion of the endovascular graft when the tip capture mechanism and the tip assembly are in the delivery position (Figure 5A; [0111]). Melsheimer teaches in Figures 6A-6C and [0058] a tip capture mechanism including a cylindrical outer surface (outer surface of cylindrical hub 32) including a proximal end and a distal end and knobs 46 having a pyramidal structure and a base having base edges, the base edges of the knobs and the proximal end and the distal end of the cylindrical outer surface bound smooth regions 30 of the cylindrical outer surface (see annotated Figure 6B above showing an outline of the smooth regions). It is noted that the claim does not require that the cylindrical outer surface proximal and distal ends and the base edges of the knobs 46 bound regions that are entirely smooth, as seen by the partial protrusions 50, nor that along the entire circumference of the cylindrical outer surface that the proximal and distal ends and the base edges of the knobs bound regions that are smooth, but merely requires that there are smooth regions, or some parts that are smooth.
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features as claimed, as taught by Schmitt and Melsheimer, since rounded apex tip capture knobs with the wider base and inclined surfaces of the pyramidal knobs may be self-aligning with an endovascular graft, provide for less shearing and jamming compared to conventional delivery systems, and allow for smoother release while providing sufficient retention (Melsheimer, [0057]; similar to advantages of cone-shaped knob embodiment in Figures 5A-5C).
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Allowable Subject Matter
Claims 1-8 are allowed.
Claims 15-16, 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record, alone or in combination, teaches or renders obvious a delivery system for delivering an endovascular graft within a blood vessel including, inter alia, a tip capture mechanism including knobs arranged around a cylindrical outer surface that extends a longitudinal axis of the tip capture mechanism, each knob having a pyramidal structure with a rounded apex and a base having base edges, contacting portion(s) of the base edges of adjacent knobs contact each other, the contacting portion(s) align along the longitudinal axis, as recited in claim 1.
None of the prior art of record, alone or in combination, teaches or renders obvious a delivery system for delivering an endovascular graft within a blood vessel including, inter alia, a tip capture mechanism including knobs arranged around a cylindrical outer surface, each knob having a pyramidal structure with a rounded apex and a base having base edges, the base edges of the knobs and the proximal end and the distal end of the cylindrical outer surface bound smooth regions of the cylindrical outer surface, wherein the smooth regions of the cylindrical outer surface are triangular shaped (as recited in claim 15), or wherein the smooth regions include proximal end bordered smooth regions spaced apart from distal end bordered smooth regions (as recited in claim 16), or wherein the knobs continuously extend around the elongated cylindrical outer surface (as recited in claim 19).
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 DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/
Primary Examiner, Art Unit 3771