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 Arguments
Applicant's arguments filed 05/22/2026 have been fully considered but they are not persuasive.
Regarding the amendments to claims 1-10, the combination of Masters and Forbes has been upheld. Masters teaches a linear pMUT array at the distal end of the catheter; when modifying the system of Masters to include the implant of Forbes, the implant would be proximal to the pMUT array. Examiner disagrees with Applicant’s arguments regarding hindsight reasoning, see Applicant’s arguments pages 9-10. Delivering implants via a catheter for LAA and ASD closure procedures is well-known in the art, as is using ultrasound to navigate to the correct position of the heart and confirm positioning of the catheter prior to implantation. Masters teaches that its device can be used for an LAA closure, but does not explicitly describe the implant used. However, it is known that implants are used for these procedures, and Forbes describes the implant. Examiner upholds the combination of Masters and Forbes to teach the full scope of the claims.
Regarding the amendments to claims 11-20, newly-found reference of Frazier has replaced previously-found reference of Forbes. Frazier teaches an implant with regards to an ASD closure.
Claim Interpretation
Interpretation of the claims has been withdrawn in response to Applicant’s amendments filed 05/22/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Masters (US 2024/0130707) in view of Forbes (US 2019/0069901).
Regarding claim 1, Masters teaches an integrated transcatheter left atrial appendage (LAA) closure and Piezoelectric Micro-Machined Ultrasonic Transducer (pMUT) ultrasonic imaging system, the system comprising:
an integrated transcatheter LAA closure assembly (ablation catheter 304, [0032]) having a longitudinal axis, a proximal end, and a distal end ([0035]), the integrated transcatheter LAA closure assembly comprising a guide catheter having a catheter sheath (sheath, [0059]); and
a micro-electromechanical (MEMS)-based pMUT transducer (imaging device 302, [0032]) having a MEMS-based pMUT array (MEMS based pMUT array 402, [0037]) disposed within the distal end of the integrated transcatheter LAA closure assembly ([0038]), wherein the MEMS-based pMUT array comprises a substrate (substrate 406, [0038]) and a plurality of pMUT array elements (pMUT array elements 404, [0038]) arranged on the substrate ([0038]), wherein:
the MEMS-based pMUT array is disposed at a distal end of the guide catheter ([0038]) and comprises a pMUT linear array ([0043] & Claim 6) configured to provide pMUT imaging guidance for placement of the guide catheter ([0003]); and
the pMUT linear array is disposed at the distal end of the guide catheter ([0038]).
However, Masters fails to disclose that the integrated transcatheter LAA closure assembly has an implant configured to close an LAA, the guide catheter having the catheter sheath configured to receive the implant for advancement into the LAA; wherein: the implant is configured to be movable from a retracted state to a deployed state; at least a portion of the MEMS-based pMUT array is distal from the implant in the retracted state; and wherein the implant is configured to be advanced through the catheter sheath of the guide catheter after the guide catheter is positioned proximate the LAA, deployed to close the LAA, and left in the LAA while the catheter sheath is removed.
Forbes teaches that the integrated transcatheter LAA closure assembly (delivery catheter 58, [0038]) has an implant (occluder device 80, [0039]) configured to close an LAA ([0039]), the guide catheter having the catheter sheath (outer sheath 56, [0037]) configured to receive the implant ([0040]) for advancement into the LAA ([0040], Figure 3A);
wherein:
the implant is configured to be movable from a retracted state ([0045] & Figure 6B) to a deployed state ([0046] & Figure 7B);
at least a portion of the MEMS-based pMUT array is distal from the implant in the retracted state ([0045] & Figure 6B); and
Paragraph [0038] of Masters teaches that the MEMS based pMUT array 402 is “disposed within the distal end of the ablation catheter 304”. Thus, the occluder device 80 of Forbes, as described in [0045] and depicted in Figure 6B, would be proximal to the MEMS-based pMUT array in the combined device. Nevertheless, [0045] of Forbes teaches that the occluder device may be advanced through the delivery catheter. Therefore, regardless of the exact position of the MEMS-based pMUT array in the catheter, the occluder device can be withdrawn so that it is proximal to the pMUT array.
wherein the implant is configured to be advanced through the catheter sheath of the guide catheter after the guide catheter is positioned proximate the LAA ([0040]), deployed to close the LAA ([0040]), and left in the LAA while the catheter sheath is removed ([0046]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Masters such that the integrated transcatheter LAA closure assembly has an implant configured to close an LAA, the guide catheter having the catheter sheath configured to receive the implant for advancement into the LAA; wherein: the implant is configured to be movable from a retracted state to a deployed state; at least a portion of the MEMS-based pMUT array is distal from the implant in the retracted state; and wherein the implant is configured to be advanced through the catheter sheath of the guide catheter after the guide catheter is positioned proximate the LAA, deployed to close the LAA, and left in the LAA while the catheter sheath is removed, as taught by Forbes. This provides functionality to the system by defining that it can be used for a well-known heart procedure. Additionally, keeping the implant in a retracted state while navigating to the heart minimizes the profile of the catheter.
Regarding claim 2, Masters in view of Forbes teach the system of claim 1, and Masters further teaches a catheter shaft (catheter shaft, [0035]) coupled to the guide catheter and configured to support advancement of the guide catheter ([0059]).
Forbes teaches positioning the catheter proximate the LAA ([0040] & Figure 3A).
Regarding claim 3, Masters in view of Forbes teach the system of claim 1, and Masters further teaches that the MEMS-based pMUT array is positioned at the distal end of the guide catheter ([0038]) to provide pMUT imaging guidance during placement of the guide catheter ([0003]).
Forbes teaches positioning the catheter proximate the LAA ([0040] & Figure 3A).
Regarding claim 4, Masters in view of Forbes teach the system of claim 3, and Masters further teaches that the distal tip of the MEMS-based pMUT array is coated with a material to provide electrical isolation and transmission of ultrasound signals (Claim 3).
Regarding claim 5, Masters in view of Forbes teach the system of claim 1, and Masters further teaches that the MEMS-based pMUT array and the integrated transcatheter LAA closure assembly is coupled to a dongle (dongle 316, [0032]), and the dongle is configured to communicated ultrasound transmit pulses and ultrasound receive waveforms between the pMUT array and the ultrasound imaging system ([0040] & Claim 4).
Forbes teaches positioning the catheter proximate the LAA ([0037] & Figure 3A).
Regarding claim 6, Masters in view of Forbes teach the system of claim 1, and Masters further teaches that each of the plurality of pMUT array elements has transducer cells (transducer cells 502, [0042]) of multiple diameters ([0042]).
Regarding claim 7, Masters in view of Forbes teach the system of claim 1, and Masters further teaches that each of the plurality of pMUT array elements is a linear phased array ([0043] & Claim 6) of the pMUT linear array disposed at the distal end of the guide catheter ([0038]).
Regarding claim 8, Masters in view of Forbes teach the system of claim 1, and Masters further teaches that the guide catheter comprises the pMUT linear array at the distal end of the guide catheter ([0038]).
Claim 9 further defines the pMUT circular array claimed in claim 1. However, claim 1 does not explicitly require the pMUT circular array, and the rejection of claim 1 does not rely on this limitation.
Regarding claim 10, Masters in view of Forbes teach the system of claim 1, and Masters further teaches that the system is deployed into chambers of a heart ([0032]).
Forbes teaches advancing the guide catheter into a left atrium ([0037]) and positioning the distal end of the guide catheter proximate the LAA ([0037] & Figure 3A).
Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Masters (US 2024/0130707) in view of Frazier (US 2004/0220596).
Claim 11 is rejected for similar reasons to claim 1. Masters further teaches that the integrated transcatheter ASD closure assembly (ablation catheter 304, [0032]) comprises a catheter (catheter shaft, [0035]) configured to extend through the atrial septal wall ([0058]).
Ablation catheter 304, taught by Masters, reads on both the integrated transcatheter LAA closure assembly and integrated transcatheter ASD closure assembly.
However, Masters fails to disclose that the integrated transcatheter ASD closure assembly has an implant configured to close an ASD, the implant comprising an atrial septum closure device having a right atrium half and a left atrium half configured to be deployed on opposite sides of an atrial septal wall, wherein: the implant is configured to be movable from a retracted state to a deployed state; at least a portion of the MEMS-based pMUT array is distal from the implant in the retracted state; and after the left atrium half and the right atrium half are deployed on opposite sides of the atrial septal wall, the catheter is configured to be detached from the left atrium and removed from a heart.
Frazier teaches that the integrated transcatheter ASD closure assembly (delivery catheter 1404, [0174]) has an implant (closure device 1404, [0174], Figure 44A) configured to close an ASD ([0174]), the implant comprising an atrial septum closure device having a right atrium half (Figure 44A) and a left atrium half (Figure 44A) configured to be deployed on opposite sides of an atrial septal wall ([0174] & Figures 44A-C), wherein:
the implant is configured to be movable from a retracted state (“The device 1400 is initially in a collapsed state in catheter 1404”, [0174]) to a deployed state (Figures 44A-C);
at least a portion of the MEMS-based pMUT array is distal from the implant in the retracted state; and
Paragraph [0038] of Masters teaches that the MEMS based pMUT array 402 is “disposed within the distal end of the ablation catheter 304”. Thus, the closure device of Frazier would be proximal to the MEMS-based pMUT array in the combined device. Nevertheless, [0174] of Frazier teaches that the closure device may be advanced through the delivery catheter. Therefore, regardless of the exact position of the MEMS-based pMUT array in the catheter, the closure device can be withdrawn so that it is proximal to the pMUT array.
after the left atrium half and the right atrium half are deployed on opposite sides of the atrial septal wall, the catheter is configured to be detached from the left atrium and removed from a heart ([0176]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Masters such that the integrated transcatheter ASD closure assembly has an implant configured to close an ASD, the implant comprising an atrial septum closure device having a right atrium half and a left atrium half configured to be deployed on opposite sides of an atrial septal wall, wherein: the implant is configured to be movable from a retracted state to a deployed state; at least a portion of the MEMS-based pMUT array is distal from the implant in the retracted state; and after the left atrium half and the right atrium half are deployed on opposite sides of the atrial septal wall, the catheter is configured to be detached from the left atrium and removed from a heart, as taught by Frazier. This provides functionality to the system by defining that it can be used for a well-known heart procedure. Additionally, keeping the implant in a retracted state while navigating to the heart minimizes the profile of the catheter.
Claim 12 is rejected for similar reasons to claim 2. Masters further teaches advancing the catheter through the atrial septal wall ([0058]).
Claim 13 is rejected for similar reasons to claim 3.
Claim 14 is rejected for similar reasons to claim 4.
Claim 15 is rejected for similar reasons to claim 5. Masters further teaches that the catheter extends through the atrial wall ([0058]).
Claim 16 is rejected for similar reasons to claim 6.
Claim 17 is rejected for similar reasons to claim 7.
Claim 18 is rejected for similar reasons to claim 8.
Claim 19 is rejected for similar reasons to claim 9.
Claim 20 is rejected for similar reasons to claim 10. Frazier further teaches advancing the catheter from a right atrium through the atrial septal wall into a left atrium ([0131]) before deployment of the atrial septum closure device ([0174]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Masters to include advancing the catheter from a right atrium through the atrial septal wall into a left atrium before deployment of the atrial septum closure device, as taught by Frazier. This path through the heart is well-known when performing an ASD closure.
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 ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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