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 .
Election/Restrictions
Applicant’s election without traverse of Species C (claims 1-5, 8-11, 13, 14, & 16-20) in the reply filed on 7/2/2026 is acknowledged.
Claims 6, 7, 12, & 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/2/2026.
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.
Claims 1, 3, 4, 8, 9, 14, & 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaplan et al. (US Pub. No. 2017/0042549 A1).
Regarding claim 1, Kaplan et al. disclose a compliance-enhancing medical implant device (Fig. 4) comprising: a corkscrew tissue anchor 406 (Fig. 4; paragraph [0087]) including a tissue-engagement portion adapted to embed in an inner wall of a ventricle of a heart (Fig. 4; paragraph [0087]); a tether line 404 (Fig. 4) coupled to the corkscrew tissue anchor 406 and dimensioned to pass through an aortic valve of the heart; and one or more compressible, compliant balloons 400 (‘plug 400’ - paragraph [0077] describes ‘plugs’ to include an encapsulating member being a thin strong layer and elastomeric; paragraph [0087] indicates that ‘plug 400’ is ‘one or two or more’) adapted to be disposed within an aorta associated with the heart and coupled to the corkscrew tissue anchor 406 through the aortic valve via the tether line 404.
Regarding claim 3, Kaplan et al. disclose compliance-enhancing medical implant device (Fig. 4) comprising: one or more balloons 400 (‘plug 400’ - paragraph [0077] describes ‘plugs’ to include an encapsulating member being a thin strong layer and elastomeric; paragraph [0087] indicates that ‘plug 400’ is ‘one or two or more’) that decrease in volume in response to external fluid pressure above a threshold pressure level (‘collapsable’ - paragraph [0077]), the one or more balloons 400 being dimensioned for placement in a blood vessel; a tether line 404 (Fig. 4) coupled to at least one of the one or more balloons 400; and a tissue anchor 406 (Fig. 4; paragraph [0087]) coupled to the tether line 404.
Regarding claim 4, Kaplan et al. further disclose wherein the tissue anchor 406 comprises a tissue-engagement portion configured to be embedded in biological tissue to secure the tissue anchor to the biological tissue (paragraph [0087]).
Regarding claim 8, Kaplan et al. further disclose wherein the one or more balloons 400 each are filled with compressible gas (the foam encapsulated within comprises pockets that are filled with air naturally encapsulated therein, which allows the foam to compress, since air is a compressible gas).
Regarding claim 9, Kaplan et al. further disclose wherein the one or more balloons 400 each comprise a frame (the foam acts as a frame that holds open the encapsulating layer, which is considered as the ‘balloon’ layer; paragraph [0077]) configured to hold open a vacuum-sealed chamber.
Regarding claim 14, Kaplan et al. further disclose wherein the one or more balloons 400 comprises at least three balloons connected in a chain (paragraph [0087] recites ‘plug 400 is one or two or more’, the ‘or more’ naturally refers to three which comes after two, therefore, it is considered to read on ‘at least three’).
Regarding claim 16, Kaplan et al. disclose a compliance-enhancing medical implant device (Fig. 4) comprising: a balloon chain 400 (Fig. 4) including a plurality of compressible balloons (‘plug 400’ - paragraph [0077] describes ‘plugs’ to include an encapsulating member being a thin strong layer and elastomeric) connected in series (paragraph [0087] recites ‘plug 400 is one or two or more’); a tether 404 (Fig. 4) coupled to a proximal-most one of the plurality of compressible balloons; and an anchor means coupled to a proximal end of the tether.
Regarding claim 17, Kaplan et al. further disclose wherein the plurality of compressible balloons 400 are filled with compressible gas (the foam encapsulated within comprises pockets that are filled with air naturally encapsulated therein, which allows the foam to compress, since air is a compressible gas
Regarding claim 18, Kaplan et al. further disclose wherein the plurality of compressible balloons 400 are vacuum-filled (the plug 400 is disclosed in paragraph [0079] as a means for sealing off the LAA, which would require the plug’s encapsulating member to form a seal around the foam therein which is considered to read on ‘vacuum-filled’ since there is no intention of air to be leaking out).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. (US Pub. No. 2017/0042549 A1) as evidenced by Bishop et al. (US Pub. No. 2018/0185152 A1).
Regarding claim 5, Kaplan et al. further disclose wherein: the tissue-engagement portion comprises a helical form (screw - paragraph [0087]) but fails to explicitly disclose wherein the tissue anchor 406 further comprises a drive head configured to be engaged and rotated by a driver instrument. However, it is considered known in the art that a drive head would be utilized to drive a screw type anchor into tissue since such an anchor would require some sort of element to drive it by nature of the design. This is evidenced by Bishop et al., paragraph [0223], which discloses a similar screw type tissue anchoring within the heart tissue and it is disclosed that ‘a tissue anchor such as a helical tissue anchor is rotated into the muscular wall by an anchor driver (not shown)’. Although Kaplan et al. fails to explicitly disclose the means for driving the screw, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the screw anchor would have a ‘drive head’ or ‘drive end’.
Allowable Subject Matter
Claims 2, 10, 11, 13, 19, & 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: Regarding claim 2, the prior art fails to further disclose, teach, or suggest wherein: the one or more compressible, compliant balloons comprises a plurality of ellipsoid balloons connected in series; and a proximal-most one of the plurality of ellipsoid balloons is coupled to the tether line. Modifying the prior art’s ‘balloon’ (plug) to have an ellipsoid shape would ruin the function of the plug since it is shaped to fit to a specific entry point (the entry to a Left Atrial Appendage) and seal it off. It is not obvious that an ellipsoid shape would be capable of performing this function and there is no further prior art to teach the same. Regarding claim 10, the prior art fails to further disclose, teach, or suggest wherein the one or more balloons comprises a first balloon and a second balloon connected by a portion of a covering that covers each of the one or more balloons. The prior art only discloses that the plug can be ‘one or two or more’ but fails to further disclose, teach, or suggest that these are connected by a portion of a covering that covers each of the one or more balloons. Regarding claim 13, the prior art fails to further disclose, teach, or suggest wherein the one or more balloons comprises a plurality of balloons including at least a first balloon and a second balloon connected in a chain arrangement by connecting lines. The prior art only discloses that the plug can be ‘one or two or more’ but fails to further disclose, teach, or suggest that these are connected in a chain arrangement by connecting lines. Regarding claim 19, the prior art fails to further disclose, teach, or suggest wherein each of the plurality of compressible balloons comprises an ellipsoid frame covered with a fluid-tight cover portion. See the reasons for allowance indicated above with respect to claim 2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat. No. 8,523,897 discloses a balloon with a distal helical anchor but fails to disclose, teach, or suggest the tether line as claimed. US Pub. No. 2014/0058371 discloses multiple balloons connected by tether but fails to disclose, teach, or suggest an anchor as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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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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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 July 25, 2026
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