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 GROUP I in the reply filed on 04/24/2026 is acknowledged. Claims 20 have been withdrawn from further consideration and claims 1-19 are pending examination.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) 1-3, 5-13 and 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lashinski (US PGPub 2022/0022854).
Regarding Claim 1, Lashinski teaches an implant for left atrial appendage closure, comprising (Figures 2A-2F):
an expandable framework (104) having a proximal end coupled to a collar (104a; Figure 2C) (For claim 2 and its dependents, the collar can be element 1416 in which the proximal end of the expandable framework (1404) is slidably coupled to the collar (1416), the expandable framework (104) configured to expand from a collapsed delivery configuration (Figure 2A) to an expanded deployed configuration (Figure 2B-2C);
a shaft (108) disposed within the collar (104a) and axially moveable relative to the collar (104a; Figures 2D-2F); and
a lock (110) coupled to the shaft (108), the lock including an engagement member (120) configured to move between a constrained configuration (Figures 2A-2C) and a radially expanded configuration (Figures 2D-2F), wherein the engagement member (120) is biased in the radially expanded configuration (Figures 2D-2F; Paragraph 0248).
Regarding Claim 2, Lashinski teaches the implant of claim 1, wherein the collar (1416; Figure 66D) holds the engagement member (1412) in the constrained configuration, and axial movement of the shaft (1408) within the collar (1416) moves the collar (1416) off the engagement member (1412), allowing the engagement member (1412) to move into the radially expanded configuration (Figures 66D-66E; Paragraph 0402).
Regarding Claim 3, Lashinski teaches the implant of claim 2, wherein the lock (110/1410; Figures 2A-2F and Figures 66A-66F) includes a plurality of arms, each arm having a first end coupled to the shaft and a second free end, the second free end configured to move between the constrained configuration and the radially expanded configuration (Figures 2A-2F and Figures 66D-66E).
Regarding Claim 5, Lashinski teaches the implant of claim 3, wherein the collar (1416) holds the second free end of each arm in the constrained configuration (Figure 66DF), and axial movement of the shaft (1408) within the collar (1416) releases the second free end of each of the plurality of arms (as seen in Figure 66E and Paragraph 0402).
Regarding Claim 6, Lashinski teaches the implant of claim 1, wherein the expandable framework (104) is biased in the expanded deployed configuration (Paragraph 0242).
Regarding Claim 7, Lashinski teaches thee implant of claim 1, wherein the expandable framework (104) includes a plurality of struts each having a proximal end, a middle portion, and distal end (see Figures 4-5 and Figures 9I), wherein the proximal ends are coupled to the collar (104a; Figure 4), the distal ends are coupled together (Figure 4), and the middle portions are moveable between the collapsed delivery configuration and the expanded deployed configuration, wherein the plurality of struts are biased in the expanded deployed configuration (Paragraph 0242).
Regarding Claim 8, Lashinski teaches the implant of claim 7, wherein at least the middle portion of each strut has a plurality of projections (118) extending laterally from the strut (Figures 4-5).
Regarding Claim 9, Lashinski teaches the implant of claim 1, further comprising a delivery rod (153) removably coupled to a proximal end of the shaft (148; Figures 9D-9E), the delivery rod (153) configured to rotate the shaft (148) and move the shaft (148) axially relative to the expandable framework (see Figures 9D-9E).
Regarding Claim 10, Lashinski teaches the implant of claim 9, wherein the shaft (see Figure 66C- 66D) includes a fastener (1414) and a nut (1450) disposed around the fastener (1414), the nut (1450) having at least one opening (1452) in a sidewall thereof (Figure 66C), wherein the collar (1407; Figure 66C) has at least one aperture (1472) through a sidewall thereof (Figure 66C), the implant further comprising at least one pin (1470/1471) extending through the aperture (1472) in the collar and the opening (1452) in the nut (Figures 66C-66D).
Regarding Claim 11, Lashinski teaches the implant of claim 10, wherein the fastener (1414) threadingly engages the nut (1450) such that rotation of the delivery rod in a first direction causes the fastener (1414) to move in a first axial direction through the nut (1450) and the collar (1407), and rotation of the delivery rod in a second direction opposite the first direction causes the fastener (1414) to move in a second axial direction through the nut (1450) and the collar (1407) (Paragraph 0416; see Figures 66D-66F).
Regarding Claim 12, Lashinski teaches the implant of claim 3, wherein the first end of each of the plurality of arms (1412; Figure 66D) is coupled adjacent a proximal end of the shaft (1408), and each arm (1412) extends distally with the collar (as seen in Figure 66D that the arms extend distally relative to the collar) holding the second free end of each arm in the constrained configuration (as seen in Figure 66D and Paragraph 0402, the collar does hold the free ends in the constrained configuration).
Regarding Claim 13, Lashinski teaches the implant of claim 12, wherein movement of the shaft (1408) distally through the collar (1416) moves the second free ends of the plurality of arms out from under the collar (1416), allowing the arms (1412) to expand into the radially expanded configuration (as seen in Figure 66E).
Regarding Claim 15, Lashinski teaches the implant of claim 3, wherein the first end of each of the plurality of arms (1412) is coupled adjacent a distal end of the shaft (1408; the examiner notes that the term adjacent is a relative term not defined in the specification and it’s the Examiner’s position that the arms are adjacent or near the distal end of the shaft 1408), and each arm (1412) extends proximally with the collar (1416) holding the second free end of each arm in the constrained configuration (as seen in Figure 66D).
Regarding Claim 16, Lashinski teaches the implant of claim 15, wherein movement of the shaft (1408) distally through the collar (1416) moves the collar (1416) proximally off the second free ends of the plurality of arms (1416), allowing the second free ends of the arms (1412) to bend radially away from a longitudinal axis of the shaft (1408) (as seen in Figure 66E and 66F).
Regarding Claim 17, Lashinski teaches an implant for left atrial appendage closure, comprising:
an expandable framework (1404; Figure 66A) having a proximal end coupled to a collar (collar can be element 1407 or element 1416 as the proximal end of the framework 1404 is coupled to both of those elements), the expandable framework (1404) configured to expand from a collapsed delivery configuration to a radially expanded configuration (Paragraph 0399 discloses an expandable implant);
a shaft (1408) disposed within the collar (1407 or 1416; Figures 66A-66B) and axially moveable relative to the collar (1407 or 1416 in Figures 66A-66B); and
a lock (1402) coupled to the shaft (1408; Figures 66A-66B), the lock (1402) including a plurality of arms (1412) each having a first end coupled to the shaft (1408) and a second free end configured to move between a constrained configuration (Figure 66DF) when positioned under the collar (1416) and a radially expanded configuration (Figure 66E) when released from the collar (1416), the plurality of arms biased in the radially expanded configuration (Paragraph 0402);
wherein the shaft (1408) is configured to rotate in a first direction causing the shaft to move axially through the collar (1416) to move the plurality of arms (1412) into the radially expanded configuration (Paragraph 0401-0402).
Regarding Claim 18, Lashinski teaches the implant of claim 17, wherein the first end of each of the plurality of arms (1412; Figure 66D) is coupled adjacent a proximal end of the shaft (1408), and each arm (1412) extends distally with the collar (as seen in Figure 66D that the arms extend distally relative to the collar) holding the second free end of each arm in the constrained configuration (as seen in Figure 66D and Paragraph 0402, the collar does hold the free ends in the constrained configuration).
Regarding Claim 19, teaches the implant of claim 17, wherein the first end of each of the plurality of arms (1412) is coupled adjacent a distal end of the shaft (1408; the examiner notes that the term adjacent is a relative term not defined in the specification and it’s the Examiner’s position that the arms are adjacent or near the distal end of the shaft 1408), and each arm (1412) extends proximally with the collar (1416) holding the second free end of each arm in the constrained configuration (as seen in Figure 66D).
Allowable Subject Matter
Claims 4 and 14 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 prior art fails to disclose:
Claim 4: the implant of claim 3, wherein the second free end of each arm extends in a proximal direction in the radially expanded configuration.
Claim 14: the implant of claim 13, wherein the second free end of each arm bends radially away from a longitudinal axis of the shaft, and then bends proximally as the shaft moves distally through the collar.
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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