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 amendments filed on 08/14/2026 have been entered. Claims 1-11 and 14-18 remain pending in the application. The amendments overcome the rejection of claim 17 under 35 USC 112(d) set forth in the previous office action dated 05/14/2026.
Response to Arguments
Applicant's arguments filed 08/14/2026 with respect to the rejection(s) of claim(s) 1 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Pah in order to teach the claimed arrangement of the stent like support structure and the plurality of struts.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 recites “the internal port” in line 2. This limitation should be changed to “an internal port” in order to provide antecedent basis for the limitation.
Appropriate correction is required.
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.
Claim(s) 1-11 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Russel (US 2015/0066075) in view of Pah (US 2010/0305604).
Regarding claim 1, Russel discloses an embolic protection method (Paragraph [0003], FIGs 5A-5E) comprising: introducing an interventional catheter (70, FIG 5E, paragraph [0050]) into a patient's femoral artery (Paragraph [0010] discloses interventional catheters being delivered by conventional femoral access); advancing an embolic filter having a filter body (12, [0031-0033]) through a patient's femoral artery (Paragraph [0010] discloses the embolic protection device and system being delivered by conventional femoral access, FIG 5B) and into the patient's aortic arch (“AA”, FIG 5B); positioning the embolic filter to locate the filter body in the aortic arch to cover the patient's aortic side branch arteries (FIG 5B-5C, wherein BA, CA, and SA are the aortic side branch arteries, paragraphs [0047-0048]); advancing the interventional catheter in parallel to the embolic filter (FIG 5E shows the parallel arrangement through the filter body), through the filter body (70 passes through 28), to the patient's aortic valve (“AV”, FIG 5E, paragraph [0051] discloses delivery to perform interventions on the aortic valve); advancing another catheter (60, FIGs 5D-5E) through the filter body (FIG 5D shows placement of 60 within the filter body by insertion through 26, both of which pass through 28); wherein both the interventional catheter and the another catheter are present in the filter body (FIG 5D-5E); and performing an intervention on the aortic valve with the interventional catheter (Paragraph [0010, 0051]), wherein the intervention can release emboli into the patient's ascending aorta (Paragraph [0010] discloses the procedures may cause emboli to be release in the arch) and wherein the filter body inhibits the entry of the emboli into the patient’s aortic side branch arteries (Paragraph [0047-0048]).
Russel is silent regarding the embolic filter having a stent like support structure attached to the embolic filter at a proximal end of the filter body, wherein a plurality of struts extends proximally from the stent like support structure, and wherein the plurality of struts is also proximal to the filter body, and further wherein the intervention catheter is advanced through the plurality of struts, the another catheter is advanced through the plurality of struts, and the intervention and another catheter are present in the filter body and the stent like support structure at the same time.
However, Pah teaches in the same field of embolic filters (1, FIG 6, abstract) for placement in the aortic arch (15, FIG 1) and insertion of interventional catheters therethrough to the aortic valve ([0121-0126]), wherein the embolic filter comprises a filter body (8, 14, FIG 6, [0058-0059 and 0098-0100]), a stent like support structure (12, [0097-0099]) attached to the embolic filter at a proximal end of the filter body (FIG 6), a plurality of struts extends proximally from the stent like support structure (Struts of tapered proximal section 7, [0099]), and wherein the plurality of struts is also proximal to the filter body (FIG 6), and further wherein the intervention catheter is advanced through the plurality of struts (The interventional catheters are delivered through catheter tube 3 and extend out of the distal end of the filter, for example as shown in FIG 7 wherein 16 is an interventional catheter, [0121]. Since the plurality of struts circumferentially surround region 7 and attached to the distal end of catheter 3 at ring 9, the interventional catheter is passed through the plurality of struts in order to extend to the distal end of the embolic filter).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the embolic filter of Russel such that is comprises the stent like support structure and the plurality of struts which attach to the delivery catheter equivalent to 26 of Russel, as taught by Pah, for the purpose of equipping the deice of Russel with a proximal lattice ring section having the benefit of providing sufficient stiffness to fit tightly against the wall of the blood vessel and secure the filter in place ([0096-0097]). In the method as modified, the another catheter is advanced through the plurality of struts, and the intervention and another catheter are present in the filter body and the stent like support structure at the same time due to the modified configuration at the proximal end of the filter body wherein each catheter now passes through the plurality of struts in order to enter the filter body and target treatment site.
Regarding claim 2, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 1. Russel further discloses the intervention comprises placement of a prosthetic aortic valve (Claim 31).
Regarding claim 3, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 1. Russel further discloses the intervention comprises repair of the patient's aortic valve (Claim 31, deployment of a prosthetic aortic valve is interpreted as repair of the aortic valve).
Regarding claim 4, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 1. Russel further discloses the intervention comprises valvuloplasty of the patient's aortic valve (Claim 31, deployment of a prosthetic aortic valve is interpreted as valvuloplasty of the aortic valve).
Regarding claim 5, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 1. Russel further discloses Russel discloses an alternative embodiment wherein intervention catheter is introduced through second port 24, which includes introducing and advancing the intervention catheter (70) by placing a first delivery sheath through the patient’s femoral artery to the patient’s aortic arch and advancing the interventional catheter therethrough (Paragraph [0020] discloses the use of a sheath to introduce “the second catheter” which is interventional catheter 70).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method as alternatively disclosed such that interventional catheter passes through the same port as the other catheter, for the purpose of achieving the predictable result of delivering both catheters to the interior of the filter body. The method as modified comprises the use of a first delivery sheath as claimed.
Regarding claim 6, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 5. Russel further discloses advancing the filter catheter comprises placing a second delivery sheath (External outer delivery sheath, paragraph [0017]) through the patient's femoral artery (the sheath is advanced though the femoral artery, [0010]) and advancing the embolic filter therethrough (In order to deploy the filter, the device is pushed distally through the sheath).
Regarding claim 7, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 1. Russel further discloses expanding the filter body to a tubular configuration to circumferentially engage a wall of the aortic arch to cover the patient's aortic side branch arteries (FIGs 5B-5C, paragraph [0048]).
Regarding claim 8, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 7. The device as modified further discloses expanding the filter body comprises expanding the stent like support structure (because the stent like support structure self expands along with the filter body upon deployment).
Regarding claim 9, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 7. Russel further discloses expanding the filter body comprises releasing the filter body from radial constraint (Paragraph [0020 and 0048] discloses the release of radial constraint allowing for expansion of body 12).
Regarding claim 10, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 9. Russel further discloses the filter body is advanced while radially constrained in a deployment catheter (outer sheath 50, FIG 4) and is deployed by retracting the deployment catheter to allow the filter body to radially expand (Paragraph [0046]).
Regarding claim 11, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 8. Russel further discloses the tubular filter body has an open upstream end (18) which faces the patient's heart (FIG 5C) to direct blood flow and emboli into the filter body (Paragraph [0030], wherein the upstream chamber is interpreted as a space within the upstream end of the filter body in the vicinity of 18), and wherein blood free from emboli flows through a tubular wall of the porous mesh into the aortic side vessels (Paragraph [0047-0048]) and blood carrying emboli flows past the stent like support structure (because the framework of struts and hoops that form the stent like structure has a porosity large enough for blood to pass through).
Regarding claim 14, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 1. Russel further discloses the another catheter comprises a diagnostic catheter (60 is a contrast delivery catheter, paragraph [0018 and 0049] and claim 30).
Regarding claim 15, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 14. Russel further discloses the diagnostic catheter is introduced before the interventional catheter is introduced (FIGs 5D-5E show the order of delivery, paragraphs [0049-0050]).
Regarding claim 16, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 15.
The method is silent regarding the diagnostic catheter being withdrawn prior to performing the intervention.
However, it would have been obvious to one of ordinary skill in the art at the time of filing that the diagnostic catheter be withdrawn before performing the intervention (Valve repair) in order to free up the lumen space and the position within the native valve where the artificial valve is to be implanted, as such that imaging to confirm the positioning can be performed before deploying the valve.
Regarding claim 17, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 1. Russel further discloses that both the interventional catheter and the other catheter are advanced through the internal port (As described in paragraph [0020], both the interventional catheter and the other catheter are advanced through a lumen of 26 and therefore are introduced through the same internal port).
Regarding claim 18, Russel/Pah discloses the invention substantially as claimed, as set forth above for claim 1. Russel further discloses after the positioning step (Such as FIG 5C), the stent like support structure is downstream of the patient's aortic side branches (As addressed above, the stent like structure is not positioned at the upstream end of the filter body, therefore it is located somewhere downstream and therefore downstream of side branches BA, CA, and SA).
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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