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 .
Specification
The disclosure is objected to because of the following informalities: paragraph [0045] refers to U.S. Patent Application No. 63/562,341 titled “Left Atrial Appendage Occluder Devices”. However, this appears to be an incorrect application number.
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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amplatz et al (US 2017/0119400).
Amplatz et al discloses the following limitations:
Claim 1. A collapsible and expandible medical device (10) for treating a target site ([0012]; left atrial appendage), the medical device comprising:
a proximal end comprising a disc (14) defining a diameter (A) in an expanded condition of the medical device;
a distal end comprising a lobe (12) defining a diameter (B) and an axial length (in the left and right direction of Fig. 1A) in the expanded condition of the medical device, the diameter of the disc being larger than the diameter of the lobe (Fig. 1A, table 1);
a connecting member (19) connecting the disc to the lobe ([0045]); and
a stabilizing wire (20) coupled to the lobe, the stabilizing wire having a backing portion (bottom of “U” shape), a first leg (left leg) extending from the backing portion, a second leg (right leg) extending from the backing portion, the first leg terminating in a first hook, the second leg terminating in a second hook, the first and second hooks being configured to engage tissue at the target site ([0041], [0042], [0046], [0047]; Figs. 4-7),
wherein the stabilizing wire has an axial length measured from a proximal-most end of the backing portion to a distal-most end of the first and second hooks when the medical device is in the expanded condition, the axial length of the stabilizing wire being between about one quarter and about one half of the axial length of the lobe (Figs. 1A, 1B, 5, 6).
Claim 2. The medical device of claim 1, wherein the lobe is formed as a braid including a first strand extending in a first direction and a second strand extending in a second direction, the first direction being angled relative to the second direction (Figs. 2, 8, 9; [0033], [0034]).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amplatz et al in view of Morin et al (US 2022/0008050).
Claim 12. Amplatz et al discloses the invention substantially as claimed above, including the lobe comprises a proximal portion defining a proximal surface of the lobe (surface facing the disc), a distal portion defining a distal surface of the lobe (surface facing on opposite side of lobe, away from disc), and a middle portion (12) connecting and extending between the proximal portion and the distal portion. Amplatz et al further discloses the transition between the middle portion and the distal surface may be tapered and angled ([0048]) but fails to disclose a first transition between the proximal portion and the middle portion being curved and a second transition between the middle portion and the distal portion being curved.
However, in the same field of endeavor, Morin et al teaches a collapsible and expandible occlusion device (110) comprising a proximal disc (116) and a distal lobe (118), wherein the lobe comprises a proximal portion defining a proximal surface (124) of the lobe, a distal portion defining a distal surface (128) of the lobe, and a middle portion (130) connecting and extending between the proximal portion and the distal portion, a first transition (T1) between the proximal portion and the middle portion being curved and a second transition (T2) between the middle portion and the distal portion being curved (Fig. 4; [0032]). Morin et al further teaches these radii of curvature of at the transitions can substitute a relatively blunt transition such as an approximately 90 degree transition ([0032]). Therefore, based upon the teachings of alternatives in Morin et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the lobe of Amplatz et al to have a curved first transition and curved second transition as claimed as Morin et al teaches these are acceptable substitutes and alternatives to provide a lobe that can predictably anchor in and occlude the left atrial appendage.
Claim 13. The combination discloses the invention substantially as claimed above, wherein Morin et al further teaches the first transition (T1) has a radius of curvature of between about 0.04 inches (about 1.016 mm) and about 0.06 inches (about 1.524 mm) ([0032]).
Claim 14. The combination discloses the invention substantially as claimed above, wherein Morin et al further teaches the second transition (T2) has a radius of curvature of between about 0.04 inches (about 1.016 mm) and about 0.06 inches (about 1.524 mm).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amplatz et al in view of Morin et al as applied to claim 12 above, and further in view of Wang et al (US 2018/0193027).
Claim 15. The combination discloses the invention substantially as claimed above, but fails to disclose in the expanded condition of the medical device, the lobe is outwardly bowed such that the middle portion of the lobe extends farther radially outwardly of a central longitudinal axis of the medical device than do the distal surface of the lobe and the proximal surface of the lobe.
However, in the same field of endeavor, Wang et al teaches a collapsible and expandable medical device for occluding the left atrial appendage, wherein in the expanded condition of the medical device, the lobe (620) is outwardly bowed such that the middle portion (622) of the lobe extends farther radially outwardly of a central longitudinal axis of the medical device than do the distal surface (surface near 624) of the lobe and the proximal surface (surface near 625) of the lobe (Figs. 17a, 17b; [0143]-[0145]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the shape of the lobe in the combination to have an outwardly bowed middle portion as claimed based upon the teachings of Wang et al to provide a shape that will radially push outwardly to provide an improved seal in the left atrial appendage during occlusion (as opposed to a cylindrical structure in Amplatz et al).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amplatz et al in view of Moszner et al (DE 10 2009 036 818; wherein the English machine translation is cited below).
Claim 16. Amplatz et al discloses a collapsible and expandible medical device (10) for treating a target site ([0012]; left atrial appendage),, the medical device comprising:
a proximal end comprising a disc (14) defining a diameter (A) in an expanded condition of the medical device;
a distal end comprising a lobe (12) defining a diameter (B) in the expanded condition of the medical device, the diameter of the disc being larger than the diameter of the lobe (Fig. 1A; table 1);
a connecting member (19) connecting the disc to the lobe ([0045]); and a
stabilizing wire (20) coupled to the lobe, the stabilizing wire being configured to engage tissue at the target site ([0041], [0042], [0046], [0047]; Figs. 4-7).
Amplatz et al fails to disclose a distal surface of the disc includes a plurality of barbs, hooks, or tines configured to frictionally engage tissue defining an ostium of the target site. However, in the same field of endeavor, Moszner et al teaches a collapsible and expandable medical device for occluding a left atrial appendage (Fig. 3), wherein a proximal disc (8; akin to the disc 14 of Amplatz et al) and a distal lobe (20; akin to the lobe 12 of Amplatz et al) are coupled together, wherein a distal surface (surface facing the distal lobe) of the disc includes a plurality of barbs (18) configured to frictionally engage tissue defining an ostium of the target site ([0036]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal surface of the disc of Amplatz et al to include a plurality of barbs as taught by Moszner et al to increase traction and assist the disc in firmly anchoring against the opening of the left atrial appendage.
Allowable Subject Matter
Claims 3-11, 17-20 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: The closest prior art of record, Amplatz et al, discloses the invention substantially as claimed above.
In regard to claim 3, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed medical device comprising, inter alia, the first leg is oriented substantially along the first direction, and the second leg is oriented substantially along the second direction. Instead, as seen in Fig. 9 of Amplatz et al, the legs of the stabilizing wire are disposed transverse to the first direction and the second direction. Wang et al further teaches wrapping a stabilizing wire (2221) with a steel bushing (3223) along a first direction of a first strand of the braid and another stabilizing wire along a second direction of a second strand of the braid (Figs. 14a, 14b; [0138]). However, the stabilizing wires of Wang et al are each their own distinct singular leg, as opposed to the claimed stabilizing wire comprising a backing portion, a first leg and a second leg extending from the backing portion. Applicant has disclosed this claim configuration is beneficial in that it may result in a reduction in inconsistency associated with using longer stabilizing wires that do not follow (or do not closely follow) the braid of the lobe ([0054]). Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
In regard to claims 17-19, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed medical device comprising, inter alia, the details of the plurality of hooks, the details of the plurality of tines, or the details of the plurality of tines. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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