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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/13/2026 has been entered.
Response to Arguments
Applicant's arguments filed 03/13/2026 have been fully considered but they are not persuasive. Applicant argues on pages 5-6 that Russel fails to teach the claimed stent like support. These arguments are pertaining to elements previously interpreted as the collapsible support. However, an alternative interpretation is provided below which provides specific teaching of an additional stent like structure attached to the filter body ([0021-0022 and 0033]). This structure meets the limitations of the claim. Therefore, applicants’ arguments pertaining to the previous interpretation of the wire/filament support is moot as it does not pertain to the present rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 depends from cancelled claim 12. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-4, 7-11, 14, 15, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Russel (US 2015/0066075).
Regarding claim 1, Russel discloses an embolic protection method (Paragraph [0003], FIGs 5A-5E) comprising: introducing a filter catheter (26) having a filter body (12, [0031-0033]) and a stent like support ([0033] discloses the filter body can be provided with additional or internal support structures, such as stents. see also [0021-0022]) through a patient's femoral artery (Paragraph [0010] discloses interventional catheters being delivered by conventional femoral access); advancing the filter catheter through the patient's femoral artery (Paragraph [0010] discloses the embolic protection device and system being delivered by conventional femoral access) and into the patient's aortic arch (“AA”, FIG 5B), wherein a distal end of the filter catheter is attached to a periphery of the stent like support at a proximal end of the filter body ([0021-0022] discloses the stent like support structure can surround the lattice of the filter body either on an inner surface or an outer surface. The distal end of the catheter 26 is attached to a proximal end of the filter body (FIG 1), and the stent like structure is attached to the inner or outer wall of the filter body somewhere along its length. [0022] discloses "stent" support structure need not be cylindrical can for example be made slightly conical with the wider end of the cone oriented toward the upstream direction, therefore the stent structure is placed in at least somewhat of a downstream location in order to have a shape which opens oriented towards the upstream direction. Therefore it is understood to be at least connected to a proximal end of the filter body); positioning the filter catheter 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]); 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 the interventional catheter in parallel to the filter catheter (FIG 5E shows the parallel arrangement through the filter body), through the filter body (70 passes through 28), and 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 the other catheter is advanced from a distal opening of a lumen of the filter catheter (Paragraph [0049]. FIG 5D-5E shows 60 extending from a distal opening of 26); wherein both the interventional catheter and the other catheter are present in the filter body and the stent like structure at the same time (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]).
Regarding claim 2, Russel discloses the intervention comprises placement of a prosthetic aortic valve (Claim 31).
Regarding claim 3, Russel 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 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 7, Russel 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 discloses expanding the filter body comprises expanding the stent like support ([0021] discloses the stent like structure assists with expanding the filter body).
Regarding claim 9, Russel 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, Russell 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 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 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 discloses the other catheter comprises a diagnostic catheter (60 is a contrast delivery catheter, paragraph [0018 and 0049] and claim 30).
Regarding claim 15, Russel 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 17, Russel discloses in the alternative 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 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).
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) 5-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Russel (US 2015/0066075).
Regarding claim 5, 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 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 filter catheter therethrough (In order to deploy the filter, the device is pushed distally through the sheath).
Regarding claim 16, Russel 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.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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