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
The amendments filed on 05/28/2026 have been entered. Claims 1-20 remain pending in this application. The amendments overcome the rejections under 35 USC 112(b) set forth in the previous office action dated 11/28/2025.
Response to Arguments
Applicant’s arguments, see pages 9-10, filed 05/28/2026, with respect to the rejection(s) of claim(s) 1, 14, and 18 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternative embodiment/interpretation of Larsen to teach the newly recited limitations regarding the individual petal groups.
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) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Center et al. (US 2015/0005810) in view of Larsen (US 2014/0142610).
Regarding claim 1, Center et al. discloses an implant (600, FIG 25, [0169-0172]) for sealing the left atrial appendage (LAA) from the left atrium ([0097, 0117, 0264]), comprising: a body having a proximal end and a distal end (Central components of the implant wherein the end nearest 612 is the distal end and the end nearest 614 is the proximal end); a disk (Shown in FIG 25; the left most disk is not numbered in this embodiment but is seen to be similar to 102, 152, 302, 722) coupled to the proximal end of the body (FIG 25 shows coupling at the proximal end at 614), the disk configured to seal the LAA ostium from the left atrium (The disk forms the occlusion frame which is understood to have a covering as disclosed in the other embodiments, abstract, [0100, 0110-0116, 0164, 0184]); a proximal anchor (602) having proximal petals (606) coupled to the body (FIG 25, attachment to 608 is interpreted as being near the proximal end), the proximal petals having a rearward curvature (See rearward curvature at the tips of the petals in FIG 25) configured to engage a wall of the (LAA When seated in the LAA, this part of the petals is at least configured to engage a wall of the LAA in a proximal region of the LAA); and a distal anchor (604) having two or more distal anchor members coupled to the body on opposing sides (Distal members 610 coupled at the distal end to 612, FIG 25), the distal members having a rearward curvature (See rearward curvature at the tips of 610 in FIG 25) configured to engage a wall of the LAA proximate a distal end of the LAA (When seated in the LAA, this part is at least configured to engage a wall of the LAA in the distal region of the LAA).
Center et al. fails to disclose the petals of the proximal anchor being asymmetrical, comprising two proximal petal groups of individual petals in each petal group, including a smaller proximal petal group having individual smaller proximal petals, and a larger proximal petal group having individual larger proximal petals, and the distal anchor having asymmetrical petals comprising two distal petal groups of individual petals in each petal group, including a smaller distal petal group having individual smaller distal petals, and a larger distal petal group having individual larger distal petals, and wherein the proximal asymmetrical petals are configured to rotate in the LAA prior to engaging the wall of the LAA so that the individual smaller proximal petals engage LAA defects, and the individual larger proximal petals engage the wall of the LAA to keep the implant centered in the LAA.
However, Center does teach that the particular design of the proximal and distal anchors is interchangeable ([0169-0171] discloses that frame 602 “may substantially correspond to any of the anchor frames discussed herein” and further disclose that any of the disclosed anchor frame designs can be implemented at various lengths along the body of the device of 600.
Further, Larsen teaches a variety of embodiments of anchor frames (FIGs 2 and 12A-21E) sized and shaped for anchoring an occluding device within the LAA ([0060] “The implantable medical devices can be deployed within the LAA”), wherein for example embodiment of FIG 2 shows petals of the anchor being asymmetrical (Due to the different size loops; wherein the device is asymmetrical at least across an axis/plane taken transverse to a direction which passes through 208 and 206), comprising two proximal petal groups of individual petals in each petal group, including a smaller proximal petal group having individual smaller proximal petals (anchors 210 having 218 which form loops/petals are interpreted as the smaller proximal petals. They are formed individually relative to the rest of frame 202 because they are made of a separate wire segment, [0080 and 0084-0086]. Any two elements 210 can be grouped together as forming a “proximal petal group”, wherein at least two groups can be formed), and a larger proximal petal group having individual larger proximal petals (Features 212 which are formed by elongate members 202 and “generally referred to as a petal”, [0078], FIG 2). Further, this design is disclosed as being implemented in a two-disc device, making up proximal and distal features of said device.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the design of both the proximal and distal anchors of Center to have individual groups of smaller and larger petal sizes, as taught by Larsen, thereby achieving the predictable result of providing a suitable anchor within the LAA and having the additional benefits disclosed by Larsen for the particular design ([0081-0082] having the fixation loops adapted to atraumatically contact tissue and minimize of prevent migration of the corresponding frame at a deployment site). Further, such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
The device as modified further meets the limitation of “wherein the proximal asymmetrical petals are configured to rotate in the LAA prior to engaging the wall of the LAA so that the individual smaller proximal petals engage LAA defects, and the individual larger proximal petals engage the wall of the LAA to keep the implant centered in the LAA” because the device is at least configured to be rotated and upon doing so, the smaller petals engage at least some portion of the wall of the LAA (Due to be positioned radially outward and because [0081] discloses their function of automatically anchoring) and the larger petals engage the wall via mechanically coupling and aid in centering because they form the structural center of each of the disks.
Regarding claim 2, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 1. Center et al. further discloses the disk has multiple/adjustable diameters to seal the LAA ostium (FIG 25 shows the tapered shape of the disk, thereby forming multiple diameters. This aids in sealing the LAA ostium because the disk can engage the ostium at the most suitable diameter).
Regarding claim 3, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 2. Center et al. further discloses the multiple/adjustable diameters include: a proximal diameter configured to engage a wall area around a proximal side of the LAA ostium (The larger proximal diameter of the disk is at least configured to engage a wall around the proximal side of the LAA ostium when the device is positioned within the LAA), and a distal diameter configured to fit within the LAA ostium to keep the disk centered in the LAA ostium (Because the distal portion of the disk has a smaller diameter, it is configured to fit within the LAA ostium and therefore aid in centering the disk within the ostium).
Regarding claim 4, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 1. Center et al. further discloses the disk is self-expanding ([0172] discloses the self expanding nature of the wires which form the frames of the device).
Regarding claim 5, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 4. Center et al. further discloses the self-expanding disk is configured to collapse or compress into a delivery configuration for delivery of the implant to the LAA, and then self-expand after delivery ([0099, 0119-0212]).
Regarding claim 6, Center et al./Larsen the invention substantially as claimed, as set forth above for claim 1. Center et al. further discloses the proximal asymmetrical petals are configured to engage the wall of the LAA on a distal side of the LAA ostium (When positioned within the LAA, the petals of 602 are distal to the ostium) and include an anchor engagement force configured to hold the disk against the wall area (The radially outwards expansion force of the petals applies said anchor engagement force).
Regarding claim 7, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 1. Center et al. further discloses the proximal and/or distal asymmetrical petals are curved petals with a fish hook shape (FIG 25 shows the curvature of the petals which forms the shape of a fish hook. Larsen also discloses [0155] that anchor features of a given device may have different angle orientations (i.e. one or more may be oriented proximally, and one or more may be oriented distally.) Therefore, it is understood that at least some petals would maintain a curvature in the device as modified).
Regarding claim 8, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 1. Center et al. further discloses the proximal and/or distal asymmetrical petals include multiple groups of petals on opposite sides of the body (As viewed in FIG 25, the two petal positioned above the axis of the body are considered one group and the two petals positioned below the axis are considered another group on an opposite side of the body).
Regarding claim 9, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 8. Center et al. further discloses the groups of proximal and/or distal asymmetrical petals include two or more petals per group (The groups as described above in claim 8 comprise at least 2 petals each).
Regarding claim 10, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 1. Center et al. further discloses wherein the proximal and/or distal asymmetrical petals are self-expanding ([0119]).
Regarding claim 11, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 1. Center et al. further discloses the disk is a self-expanding disk configured to collapse or compress into a delivery configuration for delivery of the implant to the LAA, and then self-expand after delivery ([0099, 0119-0212]).
Regarding claim 12, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 1. Center et al. further discloses the proximal and/or distal asymmetrical petals are adjustable in size (Transitioning form the collapsed to expanded configuration is interpreted as being adjustable in size because the diameter of the frame member is adjusted).
Regarding claim 13, Center et al./Larsen the invention substantially as claimed, as set forth above for claim 12. Center et al. further discloses the proximal and/or distal asymmetrical petals are adjustable either individually or in groups (The petals are interpreted as adjusting in groups when all of the distal or proximal anchor petals self expand together).
Regarding claim 14 and 15, Center et al. discloses an implant (600, FIG 25, [0169-0172]) for sealing the left atrial appendage (LAA) from the left atrium ([0097, 0117, 0264]), comprising: a body having a proximal end and a distal end (Central components of the implant there the end nearest 612 is the distal end and the end nearest 614 is the proximal end); an expandable disk (Shown in FIG 25; the left most disk is not numbered in this embodiment but is seen to be similar to 102, 152, 302, 722) coupled to the proximal end of the body (FIG 25 shows coupling at the proximal end at 614), the disk includes two diameters to seal the LAA ostium (FIG 25 shows the tapered shape of the disk, thereby forming multiple diameters. This aids in sealing the LAA ostium because the disk can engage the ostium at the most suitable diameter. Further, the disk forms the occlusion frame which is understood to have a covering as disclosed in the other embodiments, abstract, [0100, 0110-0116, 0164, 0184]): a proximal diameter configured to engage a wall area around a proximal side of the LAA ostium (The larger proximal diameter of the disk is at least configured to engage a wall around the proximal side of the LAA ostium when the device is positioned within the LAA), and a distal diameter configured to fit within the LAA ostium to keep the disk centered in the LAA ostium (Because the distal portion of the disk has a smaller diameter, it is configured to fit within the LAA ostium and therefore aid in centering the disk within the ostium); a proximal anchor (602) coupled to the body (FIG 25, attachment to 608 is interpreted as the proximal end) configured to engage a wall of the LAA near a distal side of the LAA ostium with enough force to resist pull-out (When seated in the LAA, this part of the petals is at least configured to engage a wall of the LAA in a region distal to the ostium and with enough radial force to resist dislodging of the implant); and an expandable distal anchor (604) coupled to the body (FIG 25, coupled at 612), the expandable anchor includes distal members (610) having a rearward curvature (See FIG 25) configured to engage a wall of the LAA proximate a distal end (When seated within the LAA) with enough force to resist pull-out (When seated in the LAA, this part of the frame is at least configured to engage a wall of the LAA in a region near a distal end and with enough radial force to resist dislodging of the implant).
Center et al. fails to disclose the petals of the proximal anchor being asymmetrical, comprising two proximal petal groups of individual petals in each petal group, including a smaller proximal petal group having individual smaller proximal petals, and a larger proximal petal group having individual larger proximal petals, and the distal anchor having asymmetrical petals comprising two distal petal groups of individual petals in each petal group, including a smaller distal petal group having individual smaller distal petals, and a larger distal petal group having individual larger distal petals, and wherein the proximal asymmetrical petals are configured to rotate in the LAA prior to engaging the wall of the LAA so that the individual smaller proximal petals engage LAA defects, and the individual larger proximal petals engage the wall of the LAA to keep the implant centered in the LAA.
However, Center does teach that the particular design of the proximal and distal anchors is interchangeable ([0169-0171] discloses that frame 602 “may substantially correspond to any of the anchor frames discussed herein” and further disclose that any of the disclosed anchor frame designs can be implemented at various lengths along the body of the device of 600.
Further, Larsen teaches a variety of embodiments of anchor frames (FIGs 2 and 12A-21E) sized and shaped for anchoring an occluding device within the LAA ([0060] “The implantable medical devices can be deployed within the LAA”), wherein for example embodiment of FIG 2 shows petals of the anchor being asymmetrical (Due to the different size loops; wherein the device is asymmetrical at least across an axis/plane taken transverse to a direction which passes through 208 and 206), comprising two proximal petal groups of individual petals in each petal group, including a smaller proximal petal group having individual smaller proximal petals (anchors 210 having 218 which form loops/petals are interpreted as the smaller proximal petals. They are formed individually relative to the rest of frame 202 because they are made of a separate wire segment, [0080 and 0084-0086]. Any two elements 210 can be grouped together as forming a “proximal petal group”, wherein at least two groups can be formed), and a larger proximal petal group having individual larger proximal petals (Features 212 which are formed by elongate members 202 and “generally referred to as a petal”, [0078], FIG 2). Further, this design is disclosed as being implemented in a two-disc device, making up proximal and distal features of said device.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the design of both the proximal and distal anchors of Center to have individual groups of smaller and larger petal sizes, as taught by Larsen, thereby achieving the predictable result of providing a suitable anchor within the LAA and having the additional benefits disclosed by Larsen for the particular design ([0081-0082] having the fixation loops adapted to atraumatically contact tissue and minimize of prevent migration of the corresponding frame at a deployment site). Further, such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
The device as modified further meets the limitation of “wherein the proximal asymmetrical petals are configured to rotate in the LAA prior to engaging the wall of the LAA so that the individual smaller proximal petals engage LAA defects, and the individual larger proximal petals engage the wall of the LAA to keep the implant centered in the LAA” because the device is at least configured to be rotated and upon doing so, the smaller petals engage at least some portion of the wall of the LAA (Due to be positioned radially outward and because [0081] discloses their function of automatically anchoring) and the larger petals engage the wall via mechanically coupling and aid in centering because they form the structural center of each of the disks.
Regarding claim 16, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 15. Center et al. further discloses the proximal and distal petals are configured to accommodate the anatomy of the LAA (The petals are flexible enough to accommodate a unique shape of the LAA) or placement requirement of the implant within the LAA.
Regarding claim 17, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 14. Center et al. further discloses the proximal anchor and distal anchor are configured to be collapsed or compressed in a delivery configuration for delivery of the implant to the LAA, and then self-expand after delivery ([0099, 0119-0212]).
Regarding claim 18, Center et al. discloses an implant (600, FIG 25, [0169-0172]) for sealing the left atrial appendage (LAA) from the left atrium ([0097, 0117, 0264]), comprising: a body having a proximal end and a distal end (Central components of the implant there the end nearest 612 is the distal end and the end nearest 614 is the proximal end); an expandable disk (Shown in FIG 25; the left most disk is not numbered in this embodiment but is seen to be similar to 102, 152, 302, 722) coupled to the body (FIG 25 shows coupling at the proximal end at 614), the disk includes two diameters to seal the LAA from the left atrium (FIG 25 shows the tapered shape of the disk, thereby forming multiple diameters. This aids in sealing the LAA because the disk can engage the ostium at the most suitable diameter. Further, the disk forms the occlusion frame which is understood to have a covering as disclosed in the other embodiments, abstract, [0100, 0110-0116, 0164, 0184]): a proximal diameter configured to engage a wall area around a proximal side of the LAA ostium (The larger proximal diameter of the disk is at least configured to engage a wall around the proximal side of the LAA ostium when the device is positioned within the LAA), and a distal diameter configured to fit within the LAA ostium to keep the disk centered in the LAA ostium (Because the distal portion of the disk has a smaller diameter, it is configured to fit within the LAA ostium and therefore aid in centering the disk within the ostium); an expandable proximal anchor (602) having proximal petals (606) coupled to the body on opposing sides (Each of the petals is coupled at the proximal end can be considered on an opposite side to one other petal as they are spaced radially around 608), the proximal petals having a rearward curvature (See FIG 25) configured to engage a wall of the LAA near a proximal end of the LAA with enough force to resist pull-out (When seated in the LAA, this part of the petals is at least configured to engage a wall of the LAA in a proximal region and with enough radial force to resist dislodging of the implant); and an expandable distal anchor (604), including distal members (610) having a rearward curvature (See FIG 25) configured to engage a wall of the LAA near a distal end (When seated within the LAA) with enough force to resist pull-out (When seated in the LAA, this part of the frame is at least configured to engage a wall of the LAA in a region near a distal end and with enough radial force to resist dislodging of the implant).
Center et al. fails to disclose the petals of the proximal anchor being asymmetrical, comprising two proximal petal groups of individual petals in each petal group, including a smaller proximal petal group having individual smaller proximal petals, and a larger proximal petal group having individual larger proximal petals, and the distal anchor having asymmetrical petals comprising two distal petal groups of individual petals in each petal group, including a smaller distal petal group having individual smaller distal petals, and a larger distal petal group having individual larger distal petals, and wherein the proximal asymmetrical petals are configured to rotate in the LAA prior to engaging the wall of the LAA so that the individual smaller proximal petals engage LAA defects, and the individual larger proximal petals engage the wall of the LAA to keep the implant centered in the LAA.
However, Center does teach that the particular design of the proximal and distal anchors is interchangeable ([0169-0171] discloses that frame 602 “may substantially correspond to any of the anchor frames discussed herein” and further disclose that any of the disclosed anchor frame designs can be implemented at various lengths along the body of the device of 600.
Further, Larsen teaches a variety of embodiments of anchor frames (FIGs 2 and 12A-21E) sized and shaped for anchoring an occluding device within the LAA ([0060] “The implantable medical devices can be deployed within the LAA”), wherein for example embodiment of FIG 2 shows petals of the anchor being asymmetrical (Due to the different size loops; wherein the device is asymmetrical at least across an axis/plane taken transverse to a direction which passes through 208 and 206), comprising two proximal petal groups of individual petals in each petal group, including a smaller proximal petal group having individual smaller proximal petals (anchors 210 having 218 which form loops/petals are interpreted as the smaller proximal petals. They are formed individually relative to the rest of frame 202 because they are made of a separate wire segment, [0080 and 0084-0086]. Any two elements 210 can be grouped together as forming a “proximal petal group”, wherein at least two groups can be formed), and a larger proximal petal group having individual larger proximal petals (Features 212 which are formed by elongate members 202 and “generally referred to as a petal”, [0078], FIG 2). Further, this design is disclosed as being implemented in a two-disc device, making up proximal and distal features of said device.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the design of both the proximal and distal anchors of Center to have individual groups of smaller and larger petal sizes, as taught by Larsen, thereby achieving the predictable result of providing a suitable anchor within the LAA and having the additional benefits disclosed by Larsen for the particular design ([0081-0082] having the fixation loops adapted to atraumatically contact tissue and minimize of prevent migration of the corresponding frame at a deployment site). Further, such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
The device as modified further meets the limitation of “wherein the proximal asymmetrical petals are configured to rotate in the LAA prior to engaging the wall of the LAA so that the individual smaller proximal petals engage LAA defects, and the individual larger proximal petals engage the wall of the LAA to keep the implant centered in the LAA” because the device is at least configured to be rotated and upon doing so, the smaller petals engage at least some portion of the wall of the LAA (Due to be positioned radially outward and because [0081] discloses their function of automatically anchoring) and the larger petals engage the wall via mechanically coupling and aid in centering because they form the structural center of each of the disks.
Regarding claim 19, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 18. Center et al. further discloses the proximal and distal asymmetrical petals are configured to accommodate the anatomy of the LAA (The petals are flexible enough to accommodate a unique shape of the LAA) or placement requirement of the implant within the LAA.
Regarding claim 20, Center et al./Larsen discloses the invention substantially as claimed, as set forth above for claim 18. Center et al. further discloses the proximal anchor and distal anchor are configured to be collapsed or compressed in a delivery configuration for delivery of the implant to the LAA, and then self-expand after delivery ([0099, 0119-0212]).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
Prosecution Insights