DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 1 is objected to because of the following informalities: line 8 should be amended to - move distally to expose the self-expanding prosthetic heart valve; and-. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: line 2 should be amended to - wherein withdrawing the valve brim into contact with the brim recapture funnel-. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: lines 2-3 should be amended to - the self-expanding prosthetic heart valve disposed within the distal sheath capsule, wherein [[a]] the valve brim of the self-expanding prosthetic heart valve protrudes from a proximal end-. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: line 1 should be amended to - wherein in the delivery configuration, the brim recapture funnel is disposed under the valve brim-. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1-3, 5 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20100049313 A1 to Alon et al. (Alon).
Alon discloses:
Regarding claim 1:
A catheter (figures 36, 37 and 38a-38c) for deploying a self-expanding prosthetic heart valve (10), comprising:
an outer steerable catheter (406);
an inner steerable catheter (322) disposed within (as shown in figure 38a) the outer steerable catheter (406);
an inner compression shaft (326) disposed within (as shown in figure 38a) the inner steerable catheter (322);
a distal sheath capsule (328) configured radial to contain (the valve 10 is radially contained by the distal sheath capsule 328 within 322 as shown in figure 30 since it prevents valve 10 from being removed and radially expanding) the self-expanding prosthetic heart valve (10) and connected to the inner compression shaft (326), wherein the distal sheath capsule (328) is configured to move distally to expose the self-expanding prosthetic valve (10) (under the broadest reasonable interpretation, the term “distally” has not been defined so even when the funnel moves toward 328 this can be defined as distally and during that period of time the valve 10 is still exposed as required by the claim; also, the term “exposed” has not been defined and this could include when the valve is collapsed and exposed to the sheath capsule 328); and
a brim recapture funnel (402) configured to recapture (as shown in figure 1 below) a valve brim (see the valve brim A in figure 1 below) of the self-expanding prosthetic heart valve (10).
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Figure 1 – figure 38C of Alon, annotated by the examiner
Regarding claim 2:
The catheter of claim 1, wherein the brim recapture funnel (402) is disposed on (as shown on figure 1 402 is mounted on the outside of 322) the inner steerable catheter (322).
Regarding claim 3:
The catheter of claim 2, wherein the brim recapture funnel (402) is configured for collapse by withdrawing (as shown in figure 38C the inner steerable catheter 322 is withdrawn into 406 before the funnel 402 is collapsed into 406 (see ¶0138 which also discusses how 10 is further compressed and collapsed into 322)) the inner steerable catheter (322) into the outer steerable catheter (406).
Regarding claim 5:
The catheter of claim 1, wherein the brim recapture funnel (402) is disposed on (see figure 38A where 402 is disposed on/within 406) the outer steerable catheter (406).
Regarding claim 8:
The catheter of claim 1, wherein the brim recapture funnel (402) is configured with an expanded diameter greater (see figure 1 above or figure 38C where the expanded diameter of 402 is greater than the outer diameter of the brim A in order to recapture 10) than a diameter of the valve brim (see valve brim A in figure 1 above).
Regarding claim 9:
The catheter of claim 1, wherein the brim recapture funnel (402) is configured with an expanded diameter greater (during the expansion process of the funnel 402 from figure 38a to figure 38b the diameter of 402 is greater than 328 but less than A (as shown in figure 1 above) for a period of time) than a diameter of the distal sheath capsule (328) and smaller than a diameter of the valve brim (see valve brim A in figure 1 above).
Allowable Subject Matter
Claims 4, 6, 7, 10, 18 and 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: claims 11, 13 and 15-17 is/are allowed primarily because the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Furthermore, the prior art of record does not teach “wherein collapsing the brim recapture funnel is performed by withdrawing the brim recapture funnel, attached to an inner steerable catheter of the delivery catheter, into an outer steerable catheter of the delivery catheter” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 11;
the prior art of record does not teach “wherein collapsing the brim recapture funnel is performed by withdrawing the brim recapture funnel, attached to an outer steerable catheter of the delivery catheter, into an introducer sheath” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 13; and
the prior art of record does not teach “inverting the valve brim over the distal sheath capsule through force provided by the brim recapture funnel” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 15.
Therefore, the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 10/15/25 have been fully considered but they are not persuasive.
Regarding the 35 USC 102 rejection of claim 1:
The applicant has amended the claim to overcome the previous rejection however as indicated above the Alon reference teaches the amendment.
First, the applicant has argued that the distal capsule of Alon does not keep the valve 10 radially contained (see page 9 of the remarks). However, as indicated above, the distal capsule 328 keeps the valve 10 within the sheath 322 and therefore keeps it radially contained by preventing it from escaping and expanding.
Regarding the 35 USC 102 rejections of claims 11 and 15:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn.
Regarding the 35 USC 112(b) rejections of claims 15-17:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn.
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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783