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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/18/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, “the proximal asymmetrical petals are rotated in the LAA” appears to positively recite a method step of using the device. The scope of this limitation is unclear because the claims are drawn towards an apparatus, not a method. Therefore, intended use of the device should be written as functional language.
Claim 14 recites “the proximal asymmetrical petals” in lines 11-12. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 1, 14, and 18, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 09/03/2025, 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 Therefore, the rejection has been withdrawn.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 Larsen to teach the newly recited limitations regarding the smaller and larger petals.
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 smaller and larger petal sizes, and the distal anchor having asymmetrical petals comprising two or more sizes, and wherein the proximal asymmetrical petals are rotated in the LAA prior to engaging the wall of the LAA so that the smaller petals engage LAA defects, such as a LAA bump, and the larger 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 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 21E shows petals of the anchor being asymmetrical (Due to the different size loops), comprising smaller (2102e) and larger petal sizes (The larger loop from which each smaller loop extends, [0155]). 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 with the design taught by Larsen, having smaller and larger petal sizes, 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 ([0155] 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 rotated in the LAA prior to engaging the wall of the LAA so that the smaller petals engage LAA defects, such as a LAA bump, and the larger 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 [0155] 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 smaller and larger petal sizes coupled on opposing sides, and the distal anchor having asymmetrical petals comprising two or more sizes coupled to the body on opposing sides, and wherein the proximal asymmetrical petals are configured to rotate in the LAA prior to engaging the wall of the LAA so that the smaller petals engage LAA defects, such as a LAA bump, and the larger 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 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 21E shows petals of the anchor being asymmetrical (Due to the different size loops), comprising smaller (2102e) and larger petal sizes (The larger loop from which each smaller loop extends, [0155]) coupled to a body on opposing sides (opposing sides of the central body include smaller and larger petals). 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 with the design taught by Larsen, having smaller and larger petal sizes, 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 ([0155] 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 rotated in the LAA prior to engaging the wall of the LAA so that the smaller petals engage LAA defects, such as a LAA bump, and the larger 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 [0155] 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 smaller and larger petal sizes coupled on opposing sides, and the distal anchor having asymmetrical petals comprising two or more sizes coupled to the body on opposing sides, and wherein the proximal asymmetrical petals are configured to rotate in the LAA prior to engaging the wall of the LAA so that the smaller petals engage LAA defects, such as a LAA bump, and the larger 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 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 21E shows petals of the anchor being asymmetrical (Due to the different size loops), comprising smaller (2102e) and larger petal sizes (The larger loop from which each smaller loop extends, [0155]) coupled to a body on opposing sides (opposing sides of the central body include smaller and larger petals). 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 with the design taught by Larsen, having smaller and larger petal sizes, 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 ([0155] 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 rotated in the LAA prior to engaging the wall of the LAA so that the smaller petals engage LAA defects, such as a LAA bump, and the larger 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 [0155] 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
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.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771