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 11/26/2025 have been fully considered but they are not persuasive.
Regarding the amendments to the independent claims, the combination of Masters and Forbes has been upheld. Forbes teaches that the implant has a retracted state and a deployed state, and would be proximal to the MEMS-based pMUT array when combined with the catheter of Masters.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “steering control unit” in claims 3 & 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The specification does not provide in detail what the steering control unit comprises. Thus, for the purposes of examination, “steering control unit” has been interpreted to be any arrangement capable of articulating the distal tip of a catheter.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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]); 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]).
However, Masters fails to disclose that the integrated transcatheter LAA closure assembly has an implant configured to close an LAA; wherein: the implant is configured to be movable from a retracted state to a deployed state; and at least a portion of the MEMS-based pMUT array is distal from the implant in the retracted state.
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]);
wherein:
the implant is configured to be movable from a retracted state ([0045] & Figure 6B) to a deployed state ([0046] & Figure 7B); and
at least a portion of the MEMS-based pMUT array is distal from the implant in the retracted state ([0045] & Figure 6B).
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.
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; wherein: the implant is configured to be movable from a retracted state to a deployed state; and at least a portion of the MEMS-based pMUT array is distal from the implant in the retracted state, 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]) connected at one end to a handle assembly (handle assembly 324, [0040]) and at the other end to the MEMS-based pMUT array and the integrated transcatheter LAA closure assembly ([0040]).
Regarding claim 3, 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 comprises a steering control unit (steering cables, [0039]) positioned within the handle assembly (Claim 2), for articulating a distal tip of the integrated transcatheter LAA closure assembly (Claim 2) and aligning a face of the MEMS-based pMUT array towards internal views including an anterior position or a posterior position and right or left position of the tissue (Claim 2).
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).
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).
Regarding claim 8, Masters in view of Forbes teach the system of claim 1, and Masters further teaches that the integrated transcatheter LAA closure assembly comprises a catheter having one or more pMUT arrays ([0037]).
Regarding claim 9, Masters in view of Forbes teach the system of claim 8, and Masters further teaches that the catheter has a pMUT circular array ([0043], Figures 7-8, Claim 7).
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]).
Claim 11 is rejected for similar reasons to claim 1.
Ablation catheter 304, taught by Masters, reads on both the integrated transcatheter LAA closure assembly and integrated transcatheter ASD closure assembly.
Additionally, although Forbes is drawn to an LAA occluder device, [0039] lists several specific devices that can be used with the system. One such device is the AMPLATZER, which is an ASD closure device. Thus, the reference of Forbes can be applied to an ASD closure procedure.
Claim 12 is rejected for similar reasons to claim 2.
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.
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.
Conclusion
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 M RAYMOND/Supervisory Patent Examiner, Art Unit 3798