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 Arguments
Applicant argues in the response filed 08/10/2026 that the claim amendments would overcome the previous claim objections. The objections have been withdrawn.
The applicant argues Boucek as modified by Hojeibane would not read on the limitation “the thermoplastic layer covering the proximal end of the SMA wire frame, the thermoplastic layer configured to prevent blood flow through the proximal end of the SMA wire frame” since, as argued by the applicant, the layer 405 “fills the mesh interior”. However it is noted the claim does not state the layer is radially outward the wire frame, or proximally spaced than the proximal end of the wire frame, or that the layer encapsulates the wire frame, just that the layer will cover the proximal end and prevent blood flow through the proximal end. It is further noted that flood blow does flow through the proximal end through the opening 24 of the application so the layer would not block all of the blood flow through the proximal end. The layer 405 of Boucek is placed at the proximal end (at least as taught/evidenced by other embodiments figure 3, 9) and does impede blood flow. The layer will cover, at least in a given perspective, the proximal end to prevent blood flow. Prior art Amplatz/Strauss/Karavany has been used below to further teach/provide evidence on the layer covering the proximal end to prevent blood flow through the proximal end. The examiner maintains the rejections below.
With respect to claim 12 and new claim 18, the applicant argues Boucek as modified by Hojeibane does not disclose the wire anchor is configured to be embedded within a wall of the pulmonary artery. The rejection has been withdrawn and new rejections with respect to Tafti have been made below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8, 10, 11, 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2003/0032976 to Boucek in view of U.S. Patent Publication 2005/0096735 to Hojeibane, and U.S. Patent Publication 2003/0171772 to Amplatz, U.S. Patent Publication 2012/0330348 to Strauss and/or U.S. Publication 2019/0183629 to Karavany.
As to claim 1, Boucek discloses a device capable of being a pulmonary artery flow restrictor device (paragraph 36) comprising a smart memory alloy (SMA) wire frame (402, paragraph 39, 50, the mesh can comprise nitinol which can read on the SMA) comprising a proximal end (figure 1-4), a distal end (figure 1-4), and at least one central aperture (401) configured to allow blood flow through the device (figure 4), a layer (405) covering the proximal end of the SMA wire frame (figure 1, 3, 4, 7, paragraph 39, the layer seems to be on the proximal end which will cover the proximal end, where the layer is positioned, will cover the apertures that would exist therein), the thermoplastic layer configured to prevent blood flow through the proximal end of the SMA wire frame (paragraph 39, the layer 405 occludes blood flow, which will be able to prevent blood flow through the proximal end), and a screw mechanism coil (403, paragraph 44, the attachment mechanism can be threads which will have a coil) proximally coupled to the thermoplastic layer, the screw mechanism coil configured to allow delivery and retrieval of the device (paragraph 39, 44).
Boucek discloses a fibrous substrate that fills the interior of the mesh and occludes the flow of blood (paragraph 39, figure 4). It would seem that the substrate also is located at the proximal end of the mesh/wireframe as seen in figure 4 and in the embodiments of figure 3, 7. Therefore the layer 405 will be able to cover the proximal end to prevent blood flow through the proximal end of the SMA wire frame. If it would not be known that the layer 405 can cover the proximal end of the wire frame and prevent blood flow through the proximal, it can be rendered obvious. Amplatz teaches a similar device (flow restrictor, abstract) where a fabric is placed been the two ends to prevent inhibit fluid flow through the device except by way of the lumens (paragraph 28). This would mean that the fabric would be at the proximal end outside of the aperture 22-28, to inhibit the flow of blood through the proximal end. Strauss also teaches a similar device (occlusion device, abstract) where a layer covers the proximal end of a wire frame, where the layer is configured to prevent blood flow through the proximal end of the wire frame (“membrane”, paragraph 44) to cover the device to prevent fluid flow through the proximal end. Karavany also teaches a similar device (implantable vascular device, abstract) where a layer covers the proximal end of a wire frame, where the layer is configured to prevent blood flow through the proximal end of the wire frame (figure 1a-d, paragraph 87, 88, 90) to impede fluid flow except through a desired conduit. Boucek does disclose a desired flow path 409 and the use of a layer which can prevent blood flow. Amplatz/Strauss/Karavany all can either teach and/or provide evidence on a layer which can cover the proximal end of a wire frame and prevent blood flow through the proximal end. It would have been obvious to one of ordinary skill in the art before the effective filing date for Boucek have a thermoplastic layer covering the proximal end of the SMA wire frame, the layer configured to prevent blood flow through the proximal end of the SMA wire frame in order to impede fluid flow except through a desired conduit.
However, Boucek is silent about the layer is a thermoplastic layer.
Hojeibane teaches a similar device having a thermoplastic layer (paragraph 37, 87) for the purpose of using a known material which can exhibit the desired characteristics for a layer covering. The application as originally filed states that PTFE can be used as the thermoplastic layer (paragraph 16). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the layer of Boucek be a thermoplastic layer in order to use a material with the desired characteristics for a layer covering.
As to claim 2, with the device of Boucek, Amplatz/Strauss/Karavany and Hojeibane above, Boucek discloses the SMA wire frame is nitinol (paragraph 50).
As to claim 3, with the device of Boucek and Hojeibane above, Boucek discloses the thermoplastic layer is configured to direct the blood flow through the at least one central aperture and prevent blood flow through the SMA wire frame (figure 4).
As to claim 4, with the device of Boucek, Amplatz/Strauss/Karavany and Hojeibane above, Boucek discloses the SMA wire frame is inward sloping toward the at least one central aperture (figure 4).
As to claim 5, with the device of Boucek, Amplatz/Strauss/Karavany and Hojeibane above, Boucek discloses the screw mechanism coil is coupled to the thermoplastic layer via a threaded cylindrical base (403, figure 4) extending proximally from the thermoplastic layer (figure 4).
As to claim 6, with the device of Boucek, Amplatz/Strauss/Karavany and Hojeibane above, Boucek discloses the screw mechanism is formed from SMA (paragraph 50, 36, figure 4). The mesh comprises the attachment port, where the mesh is made from SMA, so the attachment port can also be made from SMA. Therefore, Boucek can read on the screw mechanism coil can comprise SMA.
As to claim 7, with the device of Boucek, Amplatz/Strauss/Karavany and Hojeibane above, Boucek discloses an outer diameter of the SMA wire frame is sized to exceed an internal dimeter of a patient’s pulmonary artery (figure 8a, c, paragraph 44, 55, 56). The specific diameter of the artery would not be able to be positively claimed since the claim is a device claim. However, the device can be placed in the pulmonary artery as well as be sized to optimize the desired results. The diameter will be at least sized, or capable to be sized, to be larger than an internal diameter of the artery in order for the device to secure in the position as needed.
As to claim 8, with the device of Boucek, Amplatz/Strauss/Karavany and Hojeibane above, Boucek discloses the SMA wire frame comprises a plurality of SMA wires, and wherein the SMA wire frame comprises a plurality of connection points between adjacent SMA wires (figure 6, 7, paragraph 49, 50).
As to claim 10, with the device of Boucek, Amplatz/Strauss/Karavany and Hojeibane above, Boucek discloses the screw mechanism coil is configured to be reversibly coupled to a coil delivery wire (paragraph 39, 44). The matching threads are reversibly coupled.
As to claim 11, with the device of Boucek, Amplatz/Strauss/Karavany and Hojeibane above, Hojeibane further teaches the thermoplastic layer is polytetrafluoroethylene (PTFE) (paragraph 37, 87).
As to claim 13, Boucek, Amplatz/Strauss/Karavany, and Hojeibane discloses a method of treating a patient with a congenital heart defect, the method comprising implanting the device of claim 1 (of Boucek as modified by Hojeibane) in the patient’s pulmonary artery (figure 8a-c, paragraph 43-44).
As to claim 14, Boucek as modified by Amplatz/Strauss/Karavany and Hojeibane discloses the method above but is silent about the congenital heart defect is a ventricular septal defect and the device is implanted in the main pulmonary artery trunk.
Amplatz further teaches a similar method (using flow restrictors, abstract) having a method for treating a ventricular septal defect and implanting a device in the main pulmonary artery trunk (paragraph 6, 29, 30, figure 6) for the purpose of positioning the device in the desired location to treat the patient. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the method Boucek and Hojeibane to treat a ventricular septal defect by implanting the device in the main pulmonary artery trunk in order for positioning the device in the desired location to treat the patient.
As to claim 15, with the method of Boucek and Hojeibane above, Boucek discloses the congenital heart defect is hypoplastic left heart syndrome, and wherein the device is implanted in at least one of the proximal left or right pulmonary artery branches (figure 8a-c, paragraph 43-44).
As to claim 16, with the method of Boucek, Amplatz/Strauss/Karavany, and Hojeibane above, Boucek discloses the device is implanted using a cardiac catheter (812, paragraph 44).
As to claim 17, with the method of Boucek, Amplatz/Strauss/Karavany, and Hojeibane above, Boucek discloses, the device is configured to collapse within the catheter and to expand to a predetermined shape when deployed in the patient’s pulmonary artery (paragraph 44, 50, figure 8a-c, 10, 11).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2003/0032976 to Boucek in view of U.S. Patent Publication 2005/0096735 to Hojeibane and U.S. Patent Publication 2003/0171772 to Amplatz, U.S. Patent Publication 2012/0330348 to Strauss and/or U.S. Publication 2019/0183629 to Karavany as applied to claims 1-8, 10, 11, 13-17 above, and further in view of U.S. Patent Publication 2015/0142103 to Vidlund.
As to claim 9, with the device of Boucek, Amplatz/Strauss/Karavany, and Hojeibane above, Hojeibane further teaches connections points are lased welded (paragraph 57, 59) for the purpose of creating a closed cell structure. The connection points of Boucek can be welded as taught by Hojeibane to create a closed cell structure which can provide a continuous production. If it would not be known that Boucek and Hojeibane can read on the laser welding connections points, Vidlund teaches a similar device (implant retrieval devices, abstract) having laser welded connections of wires (paragraph 352, 353, 364) for the purpose of using manufacturing techniques that can maintain elastic compliance of the device. It would have been obvious to one of ordinary skill in the art before the effective filing date for the device of Boucek, Amplatz/Strauss/Karavany, and Hojeibane have the connection points be laser welded in order to use a manufacturing mechanism/technique which can provide for continuous production and/or maintaining elastic compliance of the device.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2003/0032976 to Boucek in view of U.S. Patent Publication 2005/0096735 to Hojeibane and U.S. Patent Publication 2003/0171772 to Amplatz, U.S. Patent Publication 2012/0330348 to Strauss and/or U.S. Publication 2019/0183629 to Karavany as applied to claims 1-8, 10, 11, 13-17 above, and further in view of U.S. Patent Publication 2015/0366649 to Tafti.
As to claim 12, Boucek as modified by Hojeibane and Amplatz/Strauss/Karavany discloses the device above but is silent about the at least one wire anchor coupled to an outer circumference of the SMA metal frame, the at least one wire anchor configured to be embedded within a wall of the pulmonary artery.
Tafti teaches a similar device (vasculature implant, abstract) having at least one wire anchor (29, figure 3, paragraph 34) coupled to an outer circumference of the SMA metal frame, the at least one wire anchor configured to be embedded within a wall of the pulmonary artery for the purpose of securing the device in place within the vasculature. It would have been obvious to one of ordinary skill in the art before the effective filing to use at least one wire anchor coupled to an outer circumference of the SMA metal frame of Boucek, Hojeibane, Amplatz/Strauss/Karavany, the at least one wire anchor configured to be embedded within a wall of the pulmonary artery in order to secure the device in place within the vasculature.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2003/0032976 to Boucek in view of U.S. Patent Publication 2005/0096735 to Hojeibane, U.S. Patent Publication 2015/0366649 to Tafti and U.S. Patent Publication 2003/0171772 to Amplatz, U.S. Patent Publication 2012/0330348 to Strauss and/or U.S. Publication 2019/0183629 to Karavany.
As to claim 18, Boucek discloses a device capable of being a pulmonary artery flow restrictor device (paragraph 36) comprising a smart memory alloy (SMA) wire frame (402, paragraph 39, 50, the mesh can comprise nitinol which can read on the SMA) comprising a proximal end (figure 1-4), a distal end (figure 1-4), and at least one central aperture (401) configured to allow blood flow through the device (figure 4), a layer (405) covering the proximal end of the SMA wire frame (figure 1, 3, 4, 7, paragraph 39, the layer seems to be on the proximal end which will cover the proximal end, the layer will cover any apertures between the wire frame and therefore can cover the proximal end), a screw mechanism coil (403, paragraph 44, the attachment mechanism can be threads which will have a coil) proximally coupled to the thermoplastic layer, the screw mechanism coil configured to allow delivery and retrieval of the device (paragraph 39, 44).
Boucek discloses a fibrous substrate that fills the interior of the mesh and occludes the flow of blood (paragraph 39, figure 4). It would seem that the substrate also is located at the proximal end of the mesh/wireframe as seen in figure 4 and in the embodiments of figure 3, 7. Therefore the layer 405 will be able to cover the proximal end. If it would not be known that the layer 405 can cover the proximal end of the wire frame, it can be rendered obvious or evidenced. Amplatz teaches a similar device (flow restrictor, abstract) where a fabric is placed been the two ends to prevent inhibit fluid flow through the device except by way of the lumens (paragraph 28). This would mean that the fabric would be at the proximal end outside of the aperture 22-28, to inhibit the flow of blood through the proximal end. Strauss also teaches a similar device (occlusion device, abstract) where a layer covers the proximal end of a wire frame, (“membrane”, paragraph 44) to cover the device to prevent fluid flow through the proximal end. Karavany also teaches a similar device (implantable vascular device, abstract) where a layer covers the proximal end of a wire frame, (figure 1a-d, paragraph 87, 88, 90) to impede fluid flow except through a desired conduit. Boucek does disclose a desired flow path 409 and the use of a layer which can prevent blood flow. Amplatz/Strauss/Karavany all can either teach and/or provide evidence on a layer which can cover the proximal end of a wire frame. It would have been obvious to one of ordinary skill in the art before the effective filing date for Boucek have a thermoplastic layer covering the proximal end of the SMA wire frame, in order to impede fluid flow except through a desired conduit
However, Boucek is silent about the layer is a thermoplastic layer and at least one wire anchor coupled to an outer circumference of the SMA metal frame, the at least one wire anchor configured to be embedded within a wall of the pulmonary artery.
Hojeibane teaches a similar device having a thermoplastic layer (paragraph 37, 87) for the purpose of using a known material which can exhibit the desired characteristics for a layer covering. The application as originally filed states that PTFE can be used as the thermoplastic layer (paragraph 16). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the layer of Boucek be a thermoplastic layer in order to use a material with the desired characteristics for a layer covering.
Tafti teaches a similar device (vasculature implant, abstract) having at least one wire anchor (29, figure 3, paragraph 34) coupled to an outer circumference of the SMA metal frame, the at least one wire anchor configured to be embedded within a wall of the pulmonary artery for the purpose of securing the device in place within the vasculature. It would have been obvious to one of ordinary skill in the art before the effective filing to use at least one wire anchor coupled to an outer circumference of the SMA metal frame of Boucek, Hojeibane, Amplatz/Strauss/Karavany, the at least one wire anchor configured to be embedded within a wall of the pulmonary artery in order to secure the device in place within the vasculature.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 6,468,303 to Amplatz (as cited reference D in the 892 filed 06/26/2026), U.S. Patent Publication 2006/0058833 to VanCamp, U.S. Patent Publication 2009/0171386 to Amplatz, U.S. Patent Publication 2011/0172697 to Jӧnsson, U.S. Patent Publication 2013/0138138 to Clark (as cited reference G in the 892 filed 06/26/2026), U.S. Patent Publication 2014/0018841 to Peiffer, U.S. Patent Publication 2017/0215885 to Goldie (as cited reference I in the 892 filed 06/26/2026), U.S. Patent Publication 2017/0325930 to Montgomery (as cited reference J in the 892 filed 06/26/2026), and U.S. Patent Publication 2026/0020856 to Cooper (as cited reference L in the 892 filed 06/26/2026) all disclose similar devices capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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