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 .
This office action is responsive to the preliminary amendment filed on 5/27/2022. As directed by the amendment: claim 11 has been amended. Thus, claims 1-20 are presently pending in this application, and claims 1-20 are presently under examination.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gifford et al. (EP 1129744 A1).
The examiner notes that although Gifford had been previously provided, the examiner attaches his own copy of the reference.
Regarding Claim 1, Gifford teaches a system for providing cardiac support to a patient, the system comprising:
a first elongated shaft (arterial bypass cannula 150, figs.11A, 13A, & 16, para. 0075) defining a first lumen extending therethrough, the first shaft (blood flow lumen 156)) having a proximal end portion (154) and a distal end portion (152),
wherein the distal end portion is configured to be intravascularly positioned at a first arterial location (see figure 16, see also figure 9, para. 0078, 0095 in the ascending aorta), and
wherein the lumen of the first shaft is configured to slidably receive a catheter (20, see figure 13A)housing an interventional element in a low-profile state (para. 0094-0095).
a second elongated shaft (cardiopulmonary bypass, seen in figure 8,16) defining a second lumen extending therethrough (where blood is delivered through arterial cannula 98 positioned in the femoral or iliac artery per para. 0083), the second shaft 182 having a proximal end region and a distal end region (where the distal end is within the body and the proximal end is connected to the machine),
wherein the distal end region is configured to be intravascularly positioned at a second arterial location (para. 0083); and
a pressure source (within the CPB 94) configured to generate pressure within the first lumen and the second lumen ("separate roller pump (not shown) which feeds the blood withdrawn from the heart into filter/recovery reservoir 100, then returns the blood to CPB system 94, para. 0093),
wherein the pressure source (within the CPB 94) is configured to be coupled to the proximal end portion of the first shaft and the proximal end region of the second shaft (see figure 16,where it can be seen that both the defined proximal ends of the first and second shaft are connected to the cardiopulmonary bypass and thus connected to the pump) and
wherein pressure generated by the pressure source pulls blood from the first arterial location proximally through the first shaft to the pressure source, then pushes the blood distally through the second shaft and into circulatory flow at the second arterial location, thereby providing mechanical circulatory support to the patient (para. 0063-0067).
Regarding Claim 2, Gifford teaches the pressure source is configured to generate the blood flow while the catheter is positioned within and/or extending distally from the distal end portion of the first shaft (see figs.8 and 16; para. 0063-0067).
Regarding Claim 3, Gifford teaches the pressure source is configured to be extracorporeally positioned while generating pressure (see figs.8 and 16, para. 0063-0067, where the CPB is outside the body).
Regarding Claim 4, Gifford teaches an oxygenator configured to oxygenate the blood as it flows between the distal end portion of the first shaft and the distal end region of the second shaft (“cardiopulmonary bypass (CPB) equipment to maintain circulation of oxygenated blood throughout the patient's circulatory system”, para. 0002; “deliver the deoxygenated blood to a CPB system for oxygenation”, para. 0003; see figs.8 and 16; para. 0063-0067).
Regarding Claim 5, Gifford teaches the first arterial location is within the ascending aorta(see fig.8,9,16,; para. 0056). Per the rejection of claim 1, Gifford teaches that the defined first arterial location is in the ascending aorta.
Regarding Claim 6, Gifford teaches the second arterial location is within the femoral artery (where blood is delivered through arterial cannula 98 positioned in the femoral or iliac artery per para. 0083).
Regarding Claim 7, Gifford teaches the distal end portion of the first shaft comprises a plurality of openings (see figs.13A, where outflow ports (160) are located) extending through a sidewall of the first shaft.
Regarding Claim 8, Gifford teaches a radial dimension of the distal end portion of the first shaft decreases in a distal direction (see figure 13a, where the distal end of shaft appears to be beveled or otherwise tapered and thus decreases in a radial dimension).
Regarding Claim 9, Gifford teaches the first shaft comprises a plurality of projections (folds or pleats (62), fig.4, para. 0053) extending radially inwardly from an inner surface of the first shaft. The examiner also points to figure 13B and 13c showing a valve (170) within the lumen with inwardly extending portions
Regarding Claim 10, Gifford teaches some or all of the projections ('folds or pleats 62', fig.4, para.0053, see also figure 13C) comprise a curved surface that is convex toward the first lumen.
Regarding Claim 11, Gifford teaches the distal end portion of the first shaft is configured to be positioned across a septum (see fig.9,16, part 32; para. 0095). The examiner notes that as the distal end portion of the first shaft crosses into the heart through the aorta, it is interpreted to be positioned across a septum.
Regarding Claim 12, Gifford teaches the interventional element comprises a prosthetic mitral valve (“thoracoscopic and/or endovascular instruments may be introduced into the thoracic cavity, into the heart, or into great vessels for repairing or replacing the aortic, mitral, or other heart valve”, para. 0028).
Regarding Claim 13, Gifford teaches the interventional element comprises a prosthetic aortic valve (“thoracoscopic and/or endovascular instruments may be introduced into the thoracic cavity, into the heart, or into great vessels for repairing or replacing the aortic, mitral, or other heart valve”, para. 0028).
Regarding Claim 14, Gifford teaches the interventional element comprises a heart valve repair device (“thoracoscopic and/or endovascular instruments may be introduced into the thoracic cavity, into the heart, or into great vessels for repairing or replacing the aortic, mitral, or other heart valve”, para. 0028).
Regarding Claim 15, Gifford teaches a system comprising:
a bypass device (CPB 94) comprising a first end region with an inlet (see within femoral vein (270)), a second end region with an outlet (see within iliac artery (78))), and a fluid path extending therebetween (arterial cannula (98)),
wherein the first end region is configured to be intravascularly delivered to and positioned at a first cardiovascular location (see figure 16, within femoral vein (270), para. 0090), and wherein the second end region is configured to be intravascularly delivered to and positioned at a second cardiovascular location within an artery of the patient (see figure 16, within iliac artery (78), para. 0090); and
a pressure source (within the CPB 94) disposed along the fluid path between the inlet and the outlet ("separate roller pump (not shown) which feeds the blood withdrawn from the heart into filter/recovery reservoir 100, then returns the blood to CPB system 94", para. 0093),
wherein a portion of the bypass device between the pressure source (within the CPB 94) and the inlet is configured to receive a catheter containing an interventional element (para. 0063-0067 and 0092), and
wherein, when the pressure source is activated, the pressure source pulls blood from the first cardiovascular location into the inlet, through the fluid path, and ejects the blood from the outlet to the second cardiovascular location (para. 0055, 0091,0095).
Regarding Claim 16, Gifford teaches the pressure source is configured to aspirate blood from the first cardiovascular location and eject blood to the second cardiovascular location while the catheter is positioned within the bypass device (see figs.8 and 16; para. 0063-0067).
Regarding Claim 17, Gifford teaches the pressure source is a pump (see figs.8 and 16, para. 0063-0067, roller pump).
Regarding Claim 18, Gifford teaches the pump is a roller pump (see figs.8 and 16, para. 0063-0067, 0092).
Regarding Claim 19, Gifford teaches the interventional element comprises a heart valve repair device (para. 0028, 0095).
Regarding Claim 20, Gifford teaches a system for providing cardiac support to a patient, the system comprising:
an inlet catheter ('arterial bypass cannula 150', 'shaft 22', 'guiding catheter 122', 13A,16, para. 0072, 0075) defining a first lumen extending therethrough (blood flow lumen 156) , the inlet catheter having a proximal end portion (154) and a distal end portion (152),
wherein the distal end portion is configured to be intravascularly positioned at a first arterial location see figure 16, see also figure 9, para. 0078, 0095 in the ascending aorta), and
wherein the lumen of the inlet catheter is configured to slidably receive a delivery catheter (20) housing a prosthetic heart valve (para. 0028) in a low-profile state (para. 0094-0095).
an outlet catheter ('lumen 182', fig.16, para. 0095) defining a second lumen extending therethrough, the outlet catheter 182 having a proximal end region and a distal end region (where the distal end is within the body and the proximal end is connected to the machine),
wherein the distal end region is configured to be intravascularly positioned at a second arterial location (para. 0083); and
a pump (within the CPB 94) configured to be coupled to the proximal end portion of the inlet catheter and the proximal end region of the outlet catheter ("separate roller pump (not shown) which feeds the blood withdrawn from the heart into filter/recovery reservoir 100, then returns the blood to CPB system 94", para. 0092), and
wherein pressure generated by the pump pulls blood from the first arterial location proximally through the inlet catheter to the pump, then pushes the blood distally through the outlet catheter and into circulatory flow at the second arterial location, thereby providing mechanical circulatory support to the patient (para. 0063-0067).
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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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