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 II, Species 4 (Figures 6A-6F) in the reply filed on 10/14/2025 is acknowledged.
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 19, 21-28, and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Mellmann et al. (US PGPub 2017/0258475), hereinafter known as “Mellmann,” in view of Amin (US PGPub 2009/0228038).
With regards to claim 19, Mellmann discloses (Figures 1-7b and 25-31) a method of using a device (figures 1-2) to close a left atrial appendage (LAA) in a patient (Abstract), the method comprising:
positioning the device in the LAA, wherein the device comprises a membrane 4/7 coupled at a distal end to a first connector 3, a second connector 2, a central member 24 (figure 25) having a distal end and a proximal end, wherein the distal end of the central member 24 is positioned proximate a center of the membrane (see figures 28-31) and the proximal end of the central member 24 is coupled to the second connector 2 (paragraphs 121-131), and wherein the device is positioned inside the patient in a pre-deployment configuration (figures 3a-3b); and
expanding the device from the pre-deployment configuration (figures 3a-3b; paragraph 51) to a first post-deployment configuration (figures 4a-4b; paragraph 52), wherein in said first post-deployment configuration (figures 4a-4b), the membrane 4/7 comprises a first portion 4 having a first shape, a distal end and a proximal end and a second portion 7 having a second shape, a distal end and a proximal end, wherein the distal end of the first portion 4 is coupled with the first connector 3, the proximal end of the first portion 4 is coupled with the distal end of the second portion 7 and the proximal end of the second portion 7 is coupled with the second connector 2, and when in said first post-deployment configuration (figures 4a-4b), the device has at least one first dimension and applies a first pressure against a cardiac wall (figures 4a-4b; paragraph 93); and
expanding the device from the first post-deployment configuration (figures 4a-4b) to a second post-deployment configuration (figures 6a-7b; paragraphs 54-55), wherein, when in said second post-deployment configuration (figures 6a-7b), the first shape of the first portion 4 changes to a third shape and the second shape of the second portion 7 changes to a fourth shape, and wherein each of the first shape, second shape, third shape, and fourth shape are different (as the device compresses transitioning from figure 4a to figure 7b, the shape of each portion 4/7 changes).
Mellmann is silent wherein the membrane is a tissue ingrowth member.
However, in a similar field of endeavor of LAA occluders, Amin teaches wherein the membrane 24A/24B is a tissue ingrowth member (paragraph 67; figure 10).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the membrane of Mellmann to be a tissue ingrowth member as taught by Amin for the purpose of promoting tissue growth (paragraph 67 of Amin).
With regards to claim 21, Mellmann/Amin disclose wherein the device further comprises a plurality of struts (Mellmann: 1) having distal ends and proximal ends, wherein the distal ends of the plurality of struts (Mellmann: 1) are coupled to a plurality of corresponding points along a circumference of the tissue ingrowth member (Mellmann: see figure 2 where struts 1 are connected along the circumference of the membrane 4/7, which is the tissue ingrowth member of Amin) and the proximal ends of the plurality of struts (Mellmann: 1) are coupled to the second connector (Mellmann: 2; figure 2; paragraph 84).
With regards to claim 22, Mellmann further discloses wherein the first shape 4 is a bulb shape (figure 4b) and is defined by web comprising a plurality of wires 1 (paragraph 89).
With regards to claim 23, Mellmann further discloses wherein the third shape 4 is a disc shape (figures 6b and 7b).
With regards to claim 24, Mellmann further discloses wherein the second shape 7 is a funnel shape (figure 4b), has a first length, and is defined by a web comprising a plurality of wires 1 (paragraph 89).
With regards to claim 25, Mellmann discloses wherein the fourth shape 7 is a funnel shape (figures 6b and 7b) having a second length, wherein the second length is shorter than the first length (as the device compresses, the second length shown in figures 6b and 7b is shorter than the first length of figure 4b).
With regards to claim 26, as rejected above, it would be obvious to modify the membrane of Mellmann to include the tissue ingrowth member as taught by Amin. Amin further discloses wherein the tissue ingrowth member 24A/24B is covered with a tissue ingrowth membrane made of a biocompatible material (paragraph 67). Thus, when incorporating the tissue ingrowth member of Amin, the claimed limitation is considered obvious.
With regards to claim 27, as rejected above, it would be obvious to modify the membrane of Mellmann to include the tissue ingrowth member as taught by Amin. Amin further discloses wherein the tissue ingrowth membrane 24A/24B is covered with or comprises an extracellular matrix (paragraph 67). Thus, when incorporating the tissue ingrowth member of Amin, the claimed limitation is considered obvious.
With regards to claim 28, Mellmann further discloses wherein, when in the second post-deployment configuration (figures 6b-7b), the first portion 4 in combination with the second portion 7 adopts an umbrella shape (figure 7b).
With regards to claim 36, Mellmann further discloses wherein the device further comprises a plurality of struts 1, wherein each of the plurality of struts 1 has a distal end and a proximal end and wherein at least one of the distal ends of the plurality of struts 1 and the proximal ends of the plurality of struts 1 are coupled to the second connector 3 (figure 2; paragraph 84).
With regards to claim 37, Mellmann further discloses further comprising, when the device is in the pre-deployment configuration (figures 3a-3b), positioning the device proximate the patient's heart and then releasing the device from a catheter (sheath catheter; paragraphs 44, 82, 87-88, and 105) to cause the device to partially expand into the first post-deployment configuration (figures 4a-4b; paragraph 105).
With regards to claim 38, Mellmann further discloses further comprising, after expanding the device to the first post-deployment configuration (figures 4a-4b), causing the device to fully expand into the second post-deployment configuration (figures 6a-7b; paragraphs 54-55 and 106).
Allowable Subject Matter
Claims 20 and 29-35 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:
With regards to claim 20, Mellman is silent wherein the central member is rigid and comprises a plurality of barbs along its length, wherein each of said plurality of barbs is unidirectional, and wherein the central member is configured to pass through said center of the tissue ingrowth member and said plurality of barbs is configured to engage and lock with said center of the tissue ingrowth member to lock said device in the second post-deployment configuration. The central member 24 (figures 25-31) of Mellmann is silent to the barbs, as the barbs are claimed to functionally lock the device in the second post-deployment configuration.
With regards to claim 29, Mellmann is silent to further comprising one or more phalanges coupled with the distal end of the central member, wherein expanding the device from the pre-deployment configuration to the first post-deployment configuration to the second post-deployment configuration comprises changing a configuration of the one or more phalanges from a first position in the first post-deployment configuration to a second position in the second post- deployment configuration. Claims 30-35 are objected due to being dependent off of claim 29.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 10/23/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771