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
This Office action is responsive to the amendment filed 12/23/2025. Claims1, 8 and 15 have been amended. Claim 18 has been cancelled. Claims 1-4, 6-11, 13-16 and 19 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 6-9, filed 12/23/2025, with respect to the rejections of claims 1, 8, 15 under 35 U.S.C. 103 as being unpatentable over Glimsdale (US 2013/0131717) in view of Wang et al. (US 2021/0083325) have been fully considered but they are not persuasive.
With respect to claims 1 and 8, Applicant first argues that the Glimsdale fails to teach the distal hub is disposed within an interior of the body portion.
The Examiner disagrees. The distal hub 150, taught by Glimsdale (see Fig. 6-7), is within an interior of a cup-shaped volume formed by body portion 185 (see Fig. 6) and is therefore considered within an interior of the body portion.
Further with respect to claim 1, Applicant argues that Glimsdale and Wang fail to teach a first disk portion and second disk portion that is separate from the first disk portion and is mechanically coupled to the first disk portion via a plurality of hinge members. The Examiner agrees that this limitation is not taught by Glimsdale and Wang. Therefore, the rejection to claim 1 has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Drasler (US 2018/0263658).
With respect to claim 15, Applicant argues that Glimsdale fails to teach the first disk portion is hingedly secured to the second disk portion.
The Examiner disagrees and maintains that the first and second disk portions (182, 184) taught by Glimsdale (see Fig. 6-7) are hingedly secured to one another since hinge relative to each other between the delivery and deployed configurations and therefore the connection between them functions as a living hinge.
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.
Claims 1-4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Glimsdale (US 2013/0131717) in view of Wang et al. (US 2021/0093325 ) and further in view of Drasler (US 2018/0263658).
Regarding claim 1, Glimsdale discloses an implant (100, see Fig. 7) for occluding a left atrial appendage (the implant is for treating the LAA, see [0002]), comprising: an expandable framework configured to shift between a collapsed configuration and an expanded configuration (the device has a collapsed configuration for delivery shown in Fig. 5 and an expanded configuration shown in Fig. 7 when fully deployed); wherein the expandable framework includes a body portion (185) and a disk portion (180); wherein the disk portion includes a first disk portion (182) and a second disk portion (184) that is separate from the first disk portion (the first and second disk portions are separated by space and are distinct features); wherein the expandable framework includes a proximal hub (140) and a distal hub (150); wherein the distal hub is disposed within an interior of the body portion (end feature 150 is disposed within a cup shaped volume formed by portion 185, see Fig. 6, 7).
Glimsdale fails to teach an occlusive disk element contained within the disk portion and sandwiched between and covered by the first disk portion and the second disk portion and wherein the first disk portion and the second disk portion both span an entirety of the occlusive disk element. Glimsdale also fails to teach the first and second disk portions are mechanically coupled via a plurality of hinge members.
Wang, in the same field of art, teaches a similar implant (see Fig. 4) having a disk portion (110) including an occlusive disk element secured to the interior of the disk portion to aid in occlusion of the left atrial appendage (the first frame 110 can include a polymer membrane cover on an interior surface of the frame, see [0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the implant of Glimsdale to include an occlusive disk element secured to the disk portion, as taught by Wang, since doing so would enhance the occlusive properties of the disk portion.
The combination of Glimsdale and Wang would result in the disk portion (volume portion 180) of Glimsdale having an occlusive disk element secured to the interior surface. With this arrangement the occlusive disk element would be sandwiched between and covered by the first and second disk portions (182, 184) of Glimsdale. With the occlusive disk element of Wang secured to the interior surface of the disk portion of the Glimsdale, the first and second disk portions would both span an entirety of the occlusive disk element.
The combination of Glimsdale and Wang fails to teach the first and second disk portions are mechanically coupled via a plurality of hinge members.
Drasler, in the same field of art, teaches a hinge members 820 (see Fig. 4A-4B) which mechanically couple two portions of an expandable frame (see [0046]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the hinge mechanism of Glimsdale with the hinge mechanism disclosed by Drasler since doing so would have only yielded predictable results, namely, the hinge mechanism of Drasler in the implant of Glimsdale would have allowed the device to move from a elongated delivery configuration to an expanded deployed configuration (see [0046] of Drasler). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 2, Gimsdale further discloses wherein the disk portion (180) is spaced apart from the body portion (185) in the expanded configuration (see Fig. 7).
Regarding claim 3, Gimsdale further discloses wherein the proximal hub is disposed proximal of the body portion (end feature 140 is disposed proximal of volume portion 185, see Fig. 7).
Regarding claim 4, the combination of Glimsdale, Wang and Drasler teaches the implant of claim1. Glimsdale fails to teach an occlusive element secured to the body portion.
Wang teaches an implant (see Fig. 4) having a body portion (120) including an occlusive element secured to the body portion to aid in occlusion of the left atrial appendage (the second frame 120 can include a polymer membrane cover on an interior or exterior surface of the frame, see [0096]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Glimsdale to include an occlusive element secured to the body portion, as taught by Wang, since doing so would have enhanced the occlusive properties of the implant.
Regarding claim 6, the combination of Glimsdale, Wang and Drasler further teaches wherein the first disk portion is hingedly secured to the second disk portion (surface 182 is considered to be hingedly secured to surface 184 since the bend separating the two surfaces forms a living hinge, allowing the device to move from the configuration shown in Fig. 5 to the configuration shown in Fig. 7 of Glimsdale) with the occlusive disk element trapped between the first disk portion and the second disk portion (in occlusive disk element as taught by Wang would be trapped between the first and second disk portions since Wang teaches a occlusive element lining the interior of a disk portion).
Regarding claim 7, Glimsdale further teaches wherein a neck portion (188, see Fig. 7) extends from the body portion (185) to the disk portion (180).
Claims 8-11, 13-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Glimsdale in view of Wang.
Regarding claim 8, 13-14, and 15, Glimsdale discloses an implant (100, see Fig. 7) for occluding a left atrial appendage (the implant is for treating the LAA, see [0002]), comprising: an expandable framework configured to shift between a collapsed configuration and an expanded configuration (the device has a collapsed configuration for delivery shown in Fig. 5 and an expanded configuration shown in Fig. 7 when fully deployed); wherein the expandable framework includes a body portion (185) and a disk portion (180); wherein the disk portion includes a first disk portion (182) and a second disk portion (184); wherein the expandable framework includes a proximal hub (140) and a distal hub (150); wherein the distal hub is disposed within an interior of the body portion (end feature 150 is disposed within a cup shaped volume formed by portion 185, see Fig. 6, 7). Further regarding claim 8, Glimsdale discloses wherein the distal hub faces toward the proximal hub (first and second end features 140 and 150 face the same direction along the longitudinal axis of the device, see Fig. 7). Further regarding claims 14 and 15, Glimsdale discloses wherein at least a portion of the distal hub is disposed proximal of a distalmost extent of the body portion in the expanded configuration (end feature 150 is disposed proximal of the distalmost point of volume portion 185, see Fig. 7).
Glimsdale fails to teach an occlusive disk element contained within the disk portion and sandwiched between and covered by the first disk portion and the second disk portion and wherein the first disk portion and the second disk portion both span an entirety of the occlusive disk element.
Wang, in the same field of art, teaches a similar implant (see Fig. 4) having a disk portion (110) including an occlusive disk element secured to the interior of the disk portion to aid in occlusion of the left atrial appendage (the first frame 110 can include a polymer membrane cover on an interior surface of the frame, see [0095]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the implant of Glimsdale to include an occlusive disk element secured to the disk portion, as taught by Wang, since doing so would enhance the occlusive properties of the disk portion.
The combination of Glimsdale and Wang would result in the disk portion (volume portion 180) of Glimsdale having an occlusive disk element secured to the interior surface. With this arrangement the occlusive disk element would be sandwiched between and covered by the first and second disk portions (182, 184) of Glimsdale. With the occlusive disk element of Wang secured to the interior surface of the disk portion of the Glimsdale, the first and second disk portions would both span an entirety of the occlusive disk element.
The combination of Glimsdale and Wang further teaches wherein the first disk portion is hingedly secured to the second disk portion (surface 182 is considered to be hingedly secured to surface 184 since the bend separating the two surfaces forms a living hinge, allowing the device to move from the configuration shown in Fig. 5 to the configuration shown in Fig. 7 of Glimsdale) with the occlusive disk element trapped between the first disk portion and the second disk portion (in occlusive disk element as taught by Wang would be trapped between the first and second disk portions since Wang teaches a occlusive element lining the interior of a disk portion).
Regarding claim 9, Gimsdale further discloses wherein the proximal hub is disposed proximal of the body portion (end feature 140 is disposed proximal of volume portion 185, see Fig. 7).
Regarding claims 11 and 19, the combination of Glimsdale and Wang teaches the implant of claims 8 and 15. Glimsdale fails to teach an occlusive element secured to the body portion.
Wang teaches an implant (see Fig. 4) having a body portion (120) including an occlusive element secured to the body portion to aid in occlusion of the left atrial appendage (the second frame 120 can include a polymer membrane cover on an interior or exterior surface of the frame, see [0096]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Glimsdale to include an occlusive element secured to the body portion, as taught by Wang, since doing so would have enhanced the occlusive properties of the implant.
Regarding claim 10, Glimsdale further discloses wherein the proximal hub (140, see Fig. 7) is disposed proximal of the disk portion (180).
Regarding claim 16, Glimsdale further discloses wherein the disk portion (180, see Fig. 7) includes a proximal disk portion and a distal disk portion (surfaces 182, 184 also form proximal and distal disk portions) movable relative to the proximal disk portion when the expandable framework shifts between the collapsed configuration and the expanded configuration (the proximal surface 182 is movable relative to the distal surface 184 when the device is moved between the collapsed configuration shown in Fig. 5 to the expanded configuration shown in Fig. 7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teach related devices and expandable frameworks.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771