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 claims filed on December 26th, 2025, have been entered. Claims 1-5, 8-10, and 14-27 remain pending in the Application. Claims 8 and 18-20 were previously withdrawn by the Applicant.
Response to Arguments
Some of Applicant's arguments filed December 26th, 2025, have been fully considered but they are not persuasive.
Applicant argues that Peavey et al. (Pub. No. 2003/0225421) in view of Thill et al. (Pub. No. 2003/0028213) does not disclose a continuous fabric because Thill et al. does not use the terminology continuous or uninterrupted in [0033] to describe fabric support structure 36. Examiner respectfully disagrees. [0033] describes the fabric 38 extending over the perimeter of the fabric support structure 36, which is depicted in FIG. 1, and no part of 38 is disclosed as being interrupted or in pieces. A fabric which extends over a support structure is continuous unless disclosed to be interrupted in that extension.
Applicant’s arguments, see Remarks, filed December 26th, 2025, with respect to the rejection(s) of claim(s) 1-5, 9-10, 14-17, and 21-25 under 103 over Peavey et al. in view of Thill et al. have been fully considered and are persuasive. Specifically, Applicant argued the fabric of Thill et al. does not disclose a braided fabric. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Braido et al. (Pub. No. 2016/0045165).
Applicant further argued that neither Peavey et al. nor Thill et al. disclosed free strand ends, and that the fabric of Thill et al. is not formed of shape memory material. Without conceding these arguments, Examiner has further amended the rejection below in light of Braido et al., and these arguments are now moot.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 9-10, and 22-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peavey et al. (Pub. No. 2003/0225421) in view of Thill et al. (Pub. 2003/0028213) and Braido et al. (Pub. No. 2016/0045165).
Regarding claim 1, Peavey et al. discloses a medical device (18; [0039]; FIGs. 2A-4) comprising:
a body (FIG. 2A: 18 is comprised of a body formed by 36 and 38) formed from a continuous material ([0040] 36 and 38 are continuous connecting strands), the body comprising:
a central segment (26) proximate a middle of the medical device (Annotated FIG. 2A below);
a terminus (40) proximate the middle of the medical device (Annotated FIG. 2A) and spaced from the central segment in a depthwise direction by a depth (Annotated FIG. 2A: 26 is up top while 40 is below);
a pair of inner reverse bends (32, 34) spaced apart from the central segment by a first body plane (22) that is longitudinally defined between the central segment and the pair of inner reverse bends in a first longitudinal direction (Annotated FIG. 3A below) and laterally defined between first and second edges of the body (Annotated FIG. 2A: the top and bottom edges of 18 laterally define the first body plane 22); and
a pair of outer reverse bends (46, 48), wherein the pair of outer reverse bends are spaced apart from the pair of inner reverse bends by a second body plane (Annotated FIG. 3A) that is longitudinally defined between the pair of inner reverse bends and the pair of outer reverse bends in a second, opposite longitudinal direction (Annotated FIG. 3A) and laterally defined between the first and second edges of the body (Annotated FIG. 2A: the top and bottom edges of 18 laterally define the second body plane), and wherein the pair of outer reverse bends are spaced from the terminus of the medical device by a third body plane (24) that is longitudinally defined between the pair of outer reverse bends and the terminus in the first longitudinal direction (Annotated FIG. 3A) and laterally defined between the first and second edges of the body (Annotated FIG. 2A: the top and bottom edges of 18 laterally define the third body plane 24),
wherein the medical device is a three-dimensional medical device (FIGs. 2A-4: 18 is a three-dimensional medical device), wherein first free strand ends of the material are coupled together at the central segment ([0040] the strand 28 and 30 are joined together at 26) and opposite second free strand ends of the material are coupled together at the terminus ([0041] the opposite ends of the strands 42 and 44 are joined together at 40), the material being continuous between the central segment and the terminus (Annotated FIG. 2A: 36 and 38 are continuous from 26 to 40), and between the first and second edges of the body (Annotated FIG. 2A: 36 and 38 are continuous between the top and bottom of 18).
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Peavey et al. does not disclose the continuous material is a braided shape memory fabric, and instead discloses a single-wire type frame.
Thill et al. teaches in the same field of endeavor of PFO closure devices ([0023]), and discloses PFO closure device (30; FIG. 12; [0033]) comprising a frame (36) and a fabric supported on the frame (38), where the fabric is affixed to the perimeter of the frame ([0033]) and the fabric is continuous ([0033] 38 extends uninterrupted across 36) for the purpose of accelerating the process of permanently anchoring the device in place ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of Peavy et al. to have a fabric covering the frame, as taught by Thill et al., for the purpose of accelerating the process of permanently anchoring the device in place. The modification would result in the fabric covering having the same structure as the frame as claimed above, as the fabric covering is affixed to the perimeter of the frame. It is also noted that the fabric in Thill et al. can extend over the entire PFO device, as evidenced by [0011], [0024], [0033], and [0035], as the fabric is meant to be held in intimate contact with the surface of the tissue wall to permit ingrowth of tissue into the fabric, the fabric support structure may include the wire frame, the linkage, or both, and it is desirable to provide an excess of fabric to the panel or anchor to facilitate collapse of the fabric carrying structure into a catheter.
The fabric covering of Thill et al. is not explicitly disclosed as being a braided material, though the fabric is disclosed as porous ([0034] 38 is a porous mesh).
Braido et al. teaches in the same field of endeavor of occlusive devices (Abstract), and discloses an occluder (5000; FIGs. 20A-20B) comprising a continuous braided shape memory fabric ([0156] 5000 is formed from a braided fabric, where the strands making up the fabric stretch continuously from one end of the strand at a leading end to the other end of the strand at a trailing end, and where the strands are made out of nitinol), where the first free strand ends of the braided shape memory fabric are coupled together at the central segment ([0156] the first ends of the strands making up 5000 are coupled together at the leading end) and opposite second free strand ends of the braided shape memory fabric are coupled together at the terminus ([0156] the second ends of the strands are coupled together at the trailing end).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use the continuous braided shape memory fabric of Braido et al. as the porous fabric in Thill et al. for the purpose of incorporating elastic and/or shape memory properties while providing a porous fabric (Braido et al. [0156]).
Regarding claim 2, Peavey et al. as modified by further discloses the first and second edges of the body define a pair of first legs (Peavey et al. Annotated FIG. 2A: the top and bottom of 18 define the path of the first legs) extending between the central segment and the pair of inner reverse bends, the first body plane extending between the pair of first legs (Peavey et al. Annotated FIGs. 2A and 3A).
Regarding claim 3, Peavey et al. as modified by further discloses the first and second edges of the body further define a pair of second legs (Peavey et al. Annotated FIG. 2A: the top and bottom of 18 define the path of the second legs) extending between the pair of inner reverse bends and the pair of outer reverse bends, the second body plane extending between the pair of second legs (Peavey et al. Annotated FIGs. 2A and 3A).
Regarding claim 4, Peavey et al. as modified by further discloses the first and second edges of the body further define a pair of third legs (Peavey et al. Annotated FIG. 2A: the top and bottom of 18 define the path of the third legs) extending between the pair of outer reverse bends and the terminus, the third body plane extending between the pair of third legs (Peavey et al. Annotated FIGs. 2A and 3A).
Regarding claim 5, Peavey et al. as modified by further discloses the medical device is configured to be deployed to close a Patent Foramen Ovale (PFO) (Peavey et al. [0039] 18 is a PFO closure clip), and, when the medical device is deployed, the pair of inner reverse bends are configured to engage a first surface of a septum secundum (Peavey et al. FIGs. 1 and 3B: 32 and 34 engage the septum secundum), the pair of first legs are configured to extend along the first surface of the septum secundum (Peavey et al. FIG. 3B), the pair of second legs are configured to extend between the septum secundum and a septum primum (Peavey et al. FIGs. 1 and 3B), and the pair of outer reverse bends are configured to engage a first surface of the septum primum (Peavey et al. FIGs. 1 and 3B: 46 and 48 engage the septum primum) to hold the septum secundum and the septum primum together during a cardiac cycle (Peavey et al. [0039] 18 is meant to hold 20 closed, which means bringing 14 and 16 together; FIG. 1).
Regarding claim 9, Peavey et al. as modified by further discloses the medical device is configured to be deployed to close a Patent Foramen Ovale (PFO) (Peavey et al. [0039] 18 is a PFO closure clip), and, when the medical device is deployed, the first body plane is configured to engage a first surface of a septum secundum (Peavey et al. FIGs. 1 and 3A-3B: 32 and 34 engage the septum secundum), the second body plane is configured to extend along the first surface of the septum secundum (Peavey et al. FIG. 3A-3B), and the second body plane (Examiner would note this is likely meant to refer to the third body plane instead of the second body plane, and Applicant should consider if an amendment is necessary to correct the limitation) is configured to engage a first surface of the septum primum (Peavey et al. FIGs. 1 and 3A-3B) to hold the septum secundum and the septum primum together during a cardiac cycle (Peavey et al. [0039] 18 is meant to hold 20 closed, which means bringing 14 and 16 together; FIG. 1).
Regarding claim 10, Peavey et al. as modified by further discloses, when the medical device is deployed, the pair of inner reverse bends engage a top surface of the septum secundum (Peavey et al. FIGs. 3A-3B: 32 and 34 engage the septum secundum’s top surface) and the pair of outer reverse bends engage a bottom surface of the septum primum (Peavey et al. FIGs. 3A-3B: 32 and 34 engage the septum primum’s bottom surface).
Regarding claim 22, Peavey et al. as modified by further discloses each of the first, second, and third body planes are different planes spaced from each other in the depthwise direction (Peavey et al. Annotated FIG. 3A).
Regarding claim 23, Peavey et al. as modified by further discloses each of the first, second, and third body planes are individual two-dimensional in shape (Peavey et al. Annotated FIG. 3A).
Regarding claim 24, Peavey et al. as modified by Braido et al. further discloses each of the central segment and terminus includes a respective mechanical fastener configured to prevent the first free strand ends and the second free strand ends, respectively, from unraveling (Braido et al. [0156] the strand ends can be affixed together by welding or gluing).
Regarding claim 25, Peavey et al. as modified by further discloses a width of the second body plane is a maximum width of the body (Peavey et al. Annotated FIGs. 2A and 3A: the second body plane is defined in FIG. 3A as stretching between 34 and 48, which in FIG. 2A define the maximum width of the overall body).
Regarding claim 26, Peavey et al. as modified by Thill et al. further discloses the body further comprises an inner reverse edge (Thill et al. [0033] 38 can be folded across the perimeter of the frame 36, which would form a bend in the inner reverse bends) and an outer reverse edge (Thill et al. [0033] 38 can be folded across the perimeter of the frame 36, which would form a bend in the outer reverse bends) defined by the braided shape memory fabric, wherein the inner reverse edge comprises a fold in the braided shape memory fabric that extends laterally between the pair of inner reverse bends (Thill et al. [0033] 38 can be folded across the perimeter of the frame 36, which would form a bend in the inner reverse bends) and the outer reverse edge comprises a fold in the braided shape memory fabric that extends laterally between the pair of outer reverse bends (Thill et al. [0033] 38 can be folded across the perimeter of the frame 36, which would form a bend in the outer reverse bends).
Regarding claim 27, Peavey et al. as modified by Thill et al. further discloses the continuous braided shape memory material is a mesh material (Braido et al. FIG. 20A: the fabric used to form 5000 has pores to make a mesh).
Claim(s) 14-15, 17, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peavey et al. in view of Thill et al. and Braido et al., and in further view of Prom (Pub. No. 2014/0257373).
Regarding claim 14, Peavey et al. discloses a delivery system ([0042]) for delivering a medical device (18) to a target site (20), the delivery system comprising:
a medical device (18; [0039]; FIGs. 2A-4) comprising formed from a continuous material ([0040] 36 and 38 are continuous connecting strands), the body comprising: i) a central segment (26) proximate a middle of the medical device (Annotated FIG. 2A above), ii) a terminus (40) proximate the middle of the medical device (Annotated FIG. 2A) and spaced from the central segment in a depthwise direction by a depth (Annotated FIG. 2A: 26 is up top while 40 is below), iii) a pair of inner reverse bends (32, 34) spaced apart from the central segment by a first body plane (22) that is longitudinally defined between the central segment and the pair of inner reverse bends in a first longitudinal direction (Annotated FIG. 3A above) and laterally defined between first and second edges of the body (Annotated FIG. 2A: the top and bottom edges of 18 laterally define the first body plane 22), and iv) a pair of outer reverse bends (46, 48), wherein the pair of outer reverse bends are spaced apart from the pair of inner reverse bends by a second body plane (Annotated FIG. 3A) that is longitudinally defined between the pair of inner reverse bends and the pair of outer reverse bends in a second, opposite longitudinal direction (Annotated FIG. 3A), and wherein the pair of outer reverse bends are spaced from the terminus of the medical device by a third body plane (24) that is longitudinally defined between the pair of outer reverse bends and the terminus in the first longitudinal direction (Annotated FIG. 3A) and laterally defined between first and second edges of the body (Annotated FIG. 2A: the top and bottom edges of 18 laterally define the third body plane 24), wherein the medical device is a three-dimensional medical device (FIGs. 2A-4: 18 is a three-dimensional medical device) wherein first free strands of the material are coupled together at the central segment ([0040] the stand 28 and 30 are joined together at 26) and opposite second free strand ends of the material are coupled together at the terminus ([0041] the opposite ends of the strands 42 and 44 are joined together at 40), the material being continuous between the central segment and the terminus (Annotated FIG. 2A: 36 and 38 are continuous from 26 to 40), and between the first and second edges of the body (Annotated FIG. 2A: 36 and 38 are continuous between the top and bottom of 18); and
a delivery device ([0042]) coupled to the medical device, the delivery device comprising a catheter ([0042] 18 can be deployed through a catheter).
Peavey et al. does not disclose the continuous material is a braided shape memory fabric, and instead discloses a single-wire type frame.
Thill et al. teaches in the same field of endeavor of PFO closure devices ([0023]), and discloses PFO closure device (30; FIG. 12; [0033]) comprising a frame (36) and a fabric supported on the frame (38), where the fabric is affixed to the perimeter of the frame ([0033]) and the fabric is continuous ([0033] 38 extends uninterrupted across 36) for the purpose of accelerating the process of permanently anchoring the device in place ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of Peavy et al. to have a fabric covering the frame, as taught by Thill et al., for the purpose of accelerating the process of permanently anchoring the device in place. The modification would result in the fabric covering having the same structure as the frame as claimed above, as the fabric covering is affixed to the perimeter of the frame. It is also noted that the fabric in Thill et al. can extend over the entire PFO device, as evidenced by [0011], [0024], [0033], and [0035], as the fabric is meant to be held in intimate contact with the surface of the tissue wall to permit ingrowth of tissue into the fabric, the fabric support structure may include the wire frame, the linkage, or both, and it is desirable to provide an excess of fabric to the panel or anchor to facilitate collapse of the fabric carrying structure into a catheter.
The fabric covering of Thill et al. is not explicitly disclosed as being a braided material, though the fabric is disclosed as porous ([0034] 38 is a porous mesh).
Braido et al. teaches in the same field of endeavor of occlusive devices (Abstract), and discloses an occluder (5000; FIGs. 20A-20B) comprising a continuous braided shape memory fabric ([0156] 5000 is formed from a braided fabric, where the strands making up the fabric stretch continuously from one end of the strand at a leading end to the other end of the strand at a trailing end, and where the strands are made out of nitinol).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use the continuous braided shape memory fabric of Braido et al. as the porous fabric in Thill et al. for the purpose of incorporating elastic and/or shape memory properties while providing a porous fabric (Braido et al. [0156]).
Peavey et al. as modified by Thill et al. and Braido et al. does not disclose the delivery device further comprises a delivery cable, wherein the medical device is coupled to the delivery cable, and wherein the delivery cable is configured to be advanced through the catheter to deploy the medical device at the target site.
Prom teaches in the same field of endeavor of medical devices (Abstract), and discloses a medical device (48; [0050]; FIG. 9) and a delivery device (38) coupled to the medical device, the delivery device comprising a catheter ([0051] outer delivery wire 38 can go through a delivery catheter) and a delivery cable (34), wherein the medical device is coupled to the delivery cable (FIG. 9: 48 is coupled to 38 by threaded connection between 20 and 52), and wherein the delivery cable is configured to be advanced through the catheter to deploy the medical device at the target site ([0051] 38 can deploy 48 from a delivery catheter) for the purpose of being able to recapture the medical device ([0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the delivery device of Peavey et al. to include a delivery cable coupled to the medical device which is configured to be advanced through the catheter to deploy the medical device at the target site, as taught by Prom, for the purpose of properly orienting the medical device for insertion and deployment.
Regarding claim 15, Peavey et al. as modified further discloses the target site is a PFO (Peavey et al. [0039] 18 is a PFO closure clip) and, when deployed, the medical device is configured to close the PFO by securing together a septum primum and a septum secundum of the PFO (Peavey et al. [0039] and FIG. 3B).
Regarding claim 17, Peavey et al. as modified by Prom further discloses the delivery cable is coupled to the central segment of the medical device (Prom [0050] 38 is coupled to a connecting segment 20, which is at the proximal end of 48; the equivalent proximal end structure in Peavey et al. would be located at 26, so 38 would be coupled there in the modification).
Regarding claim 21, Peavey et al. as modified by Thill et al. discloses the invention as claimed in claim 1, as discussed above. Peavey et al. does not disclose an extension extending from the central segment and a coupling mechanism at a free end of the extension, the coupling mechanism configured to enable coupling the medical device to a delivery cable for deployment of the medical device.
Prom teaches in the same field of endeavor of medical devices (Abstract), and discloses a delivery device (20 and 38; FIG. 9; [0050]) comprising an extension extending from the central segment (34) and a coupling mechanism (20 and 52), the coupling mechanism configured to enable coupling the medical device to a delivery cable (38) for deployment of the medical device ([0050] 20 and 52 can releasably attach to allow 48 to be coupled to 38) for the purpose of enabling the retrieval of the device in case of improper deployment ([0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the medical device of Peavey et al. to include an extension extending from the central segment and a coupling mechanism at a free end of the extension configured to enable coupling the medical device to a delivery cable for deployment of the medical device, as taught by Prom, for the purpose of enabling the retrieval of the device in case of improper deployment.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peavey et al. in view of Thill et al., Braido et al., and Prom, and in further view of Auth et al. (U.S. Patent App. No. 2006/0122680).
Regarding claim 16, Peavey et al. as modified by Thill et al., Braido et al., and Prom discloses the invention as claimed in claim 14, as discussed above. Peavey et al. does not disclose the catheter has an outer diameter of about 9 French (Peavey et al. [0042] does not specify the size of the catheter).
Auth et al. teaches in the same field of endeavor of medical devices for closing PFOs, and discloses a catheter with an outer diameter of about 9 French ([0024] catheter 220, for insertion into a PFO tunnel, has a diameter of 9-15 French).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter in Peavey et al. to have an outer diameter of about 9 French, as taught by Auth et al., for the purpose of delivering the medical device to a PFO site (Auth et al. [0024]). Further, it would have been obvious to one of ordinary skill in the art to use a catheter of about 9 French since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert denied, 469 U.S. 830, 225 SPQ 232 (1984).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771