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 Amendment
In response to the amendment filed on 03/13/2026, No Claims have been cancelled, and Claims 1-19 are pending. Claim 20 was withdrawn by Applicant.
Election/Restrictions
Applicant’s election WITHOUT traverse of GROUP I, Species A in the reply filed on 03/13/2026 is acknowledged.
In the response filed 03/13/2026, Applicant indicated claims 1-19 read on elected Species A (Figures 4B). However, claims 6-19 recites “wherein the cinching member is an expandable stent having stent capture features configured to move between a release and punch configuration, which reads on the embodiment of Figures 8A-15 and thus are drawn to non-elected Species B-H. Accordingly, claims 6-19 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B (Figures 2A-2B and 6), there being no allowable generic or linking claim.
Claims 6-20, drawn to the inventions of Groups II and Species B-H, have been withdrawn. Claims 1-5 are pending examination.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bortlein (US PGPub 2014/0277411).
Regarding Claim 1, Bortlein teaches a medical system (Figure 11A), comprising:
a left atrial appendage closure device including an expandable framework (30; Figures 11A-11B) configured to shift between a collapsed delivery configuration and an expanded deployed configuration (Paragraph 0047; the Examiner notes that the term “left atrial appendage closure device is an intended used and the expandable prosthesis taught by Bortlien can be placed within an LAA when intended), the expandable framework (30) having an outer diameter in the expanded deployed configuration (Figures 11A-11B); and
a cinching member (80; Figures 11A-11B; Paragraph 0085-0086) configured to shift between a compressed delivery configuration and an expanded configuration (Paragraph 0085), the cinching member (80) being ring shaped with an inner diameter in the expanded configuration that is larger than the outer diameter of the left atrial appendage closure device (30; Figures 11A-11B, the cinching member is sleeved over section 32 and thus has an inner diameter larger than the outer diameter of section 32), the cinching member (80) have a plurality of tissue engagement elements (230; Figures 20-22; Paragraph 0088) defined on an outer surface thereof (Figure 22).
Regarding Claim 2, Bortlein teaches the medical system of claim 1, wherein the cinching member (80) is balloon expandable until an outer diameter of the cinching member is larger than an inner diameter of a patient's left atrial appendage (Paragraph 0090 and 0102).
Regarding Claim 3, Bortlein teaches the medical system of claim 1, wherein the plurality of tissue engagement elements (230) are radially extending hooks (Figure 22; Paragraph 0088).
Regarding Claim 4, Bortlein teaches the medical system of claim 2, wherein the balloon expandable cinching member (80) is a flexible polymer ring (Paragraph 0103).
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(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bortlein (US PGPub 2014/0277411).
Regarding Claim 5, Bortlien teaches the medical system of claim 4, further comprising a tether (260; Figures 25A-25C) (130; Figures 15B) releasably coupled with the balloon expandable cinching member (80; Figures 15B and Figures 25A-25C)
Bortlien fails to disclose a plurality of tethers that are releasably coupled.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to duplicate the amount of tethers attached to the cinching member, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Examiner Note
The Examiner suggests amending Claim 5 to recite a plurality of tethers attached through eyelets of the cinching members as shown in Applicant’s Figure 7 to overcome the current art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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