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 .
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 1-5, 7, 13-17 and 20 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Anderson et al. (US 2020/0178981, hereinafter “Anderson”).
In regards to claims 1 and 16, Anderson discloses a catheter (Fig. 3, element 110) with an elongate tubular body and a central lumen that extends from a proximal end to a distal end of the catheter, the distal end arranged to be positioned at an opening of the left atrial appendage (Figs. 3 and 4);
an occlusion device for occluding a left atrial appendage (Figs. 6-8, all elements), the device comprising:
a stem with an elongate tubular body and a central lumen that extends from a proximal end to a distal end (element 240; par. 0061, “the flexible coupler 240 is tubular (e.g., a tubular member, a hollow tube, etc.) and includes a lumen extending therethrough”),
a proximal portion arranged at the proximal end of the stem (element 230);
wherein the proximal portion is arranged to engage with an opening of the left atrial appendage (Figs. 6-8; abstract),
an expandable member arranged at the distal end of the stem (elements 250, 220, 210; par. 0067);
wherein the central lumen of the stem is in fluid communication with the expandable member and wherein the expandable member is arranged to be positioned inside a left atrial appendage (par. 0067, “the tapered member 250 may be an inflatable tapered member configured to expand axially and/or radially/laterally, wherein different degrees and/or magnitudes of inflation determine adjustment of the gap distance G”);
and wherein the expandable member is operable to at least partially expand and displace the proximal portion in a direction towards the expandable member (par. 0067, “as the tapered member 250 is inflated, the distal end of the flexible coupler 240 may be translated and/or pulled distally through and/or relative to the expandable framework 210, thereby shortening and/or reducing the gap distance G, and translating the sealing member 230 towards and/or into the ostium 56 of the left atrial appendage 50, as shown in FIGS. 7 and 8 for example”),
wherein the occlusion device is releasably connected to the distal end of the catheter (par. 0064).
In regards to claim 2, the expandable member is arranged to receive fluid through the central lumen of the stem so as to at least partially expand within the left atrial appendage (Fig. 9; par. 0070, “the distal end of the flexible coupler 240 and/or the threaded portion 260 may be self-sealing, and/or may include a hemostasis valve or other feature, such that withdrawal of the distal end of the core wire 130 therethrough permits the sealing member 230 to retain inflation fluid therein”).
In regards to claim 3, the expandable member (elements 250, 220, 210) is asymmetric, having a width greater than its height (Figs. 6-8).
In regards to claim 4, the width of the expandable member is substantially oval or elliptical shaped (Fig. 9).
In regards to claim 5, the expandable member comprises a nitinol mesh (par. 0083, expandable mesh framework 210 can comprise nitinol).
In regards to claim 7, the stem is in fluid communication with the expandable member through at least one aperture extending from the central lumen of the stem (Fig. 9, pars. 0061, 0063, 0067).
In regards to claim 13, the proximal portion (element 230) is dome shaped and an apex of the dome is proximal to the expandable member (par. 0068; Figs. 6-8; “shape similar to a flat-capped mushroom”).
In regards to claim 14, the proximal portion comprises a bioinert polymer (par. 0090).
In regards to claim 15, the proximal portion is at least partially coated with a material coating (par. 0093).
In regards to claim 17, the occlusion assembly further comprises a fluid source coupled to the catheter, wherein the fluid source is operable to deliver fluid to the expandable member (par. 0067).
In regards to claim 20, the fluid is one of: biogel, saline or contrast media (pars. 0063, 0077).
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.
Claims 10, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Edmiston et al. (US 9,649,115, hereinafter “Edmiston”). Anderson discloses the essential features of the claimed invention including a distal fluid aperture, but does not expressly disclose that the fluid aperture is arranged to be in fluid communication with the left atrial appendage, and wherein the fluid source is further operable to deliver fluid into the left atrial appendage; or wherein the occlusion assembly further comprises a plunger with a proximal end and a distal end, wherein the proximal end of the plunger is housed in the distal end of the catheter and the distal end of the plunger is releasably connected to the proximal portion of the occlusion device, so that the occlusion device is releasably connected to the catheter through the plunger. However, Edmiston in the same field of endeavor of left atrial appendage occluders teaches providing a fluid aperture that is arranged to be in fluid communication with the left atrial appendage (abstract) to provide the predictable results of a fluid flow path that facilitates contrast fluid to pass through the delivery catheter and the medical device to a distal side thereof to provide imaging information as to the position of the medical device positioned in the opening, such as the left atrial appendage (abstract), and wherein the fluid source is further operable to deliver fluid into the left atrial appendage; and wherein the occlusion assembly further comprises a plunger with a proximal end and a distal end, wherein the proximal end of the plunger is housed in the distal end of the catheter and the distal end of the plunger is releasably connected to the proximal portion of the occlusion device, so that the occlusion device is releasably connected to the catheter through the plunger (Figs. 8, 8A, 9, 9A; col. 17, line 66 to col. 18, line 53) to provide the predictable results of allowing the physician to more accurately place the device in the desired location (col. 18, lines 19-46). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Anderson by providing a fluid aperture that is arranged to be in fluid communication with the left atrial appendage to provide the predictable results of a fluid flow path that facilitates contrast fluid to pass through the delivery catheter and the medical device to a distal side thereof to provide imaging information as to the position of the medical device positioned in the opening, such as the left atrial appendage, and wherein the fluid source is further operable to deliver fluid into the left atrial appendage; and wherein the occlusion assembly further comprises a plunger with a proximal end and a distal end, wherein the proximal end of the plunger is housed in the distal end of the catheter and the distal end of the plunger is releasably connected to the proximal portion of the occlusion device, so that the occlusion device is releasably connected to the catheter through the plunger to provide the predictable results of allowing the physician to more accurately place the device in the desired location.
Allowable Subject Matter
Claims 6, 8, 9, 11 and 12 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Harari et al. (US 2022/0370079) is another example of a left atrial appendage occlusion device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. 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, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792