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 .
Claim Objections
Claim 2 is objected to because of the following informalities: For consistency and clarity purposes, line 1 should read “the SMA wire frame”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: For consistency and clarity purposes, line 2 should read “the SMA wire frame”. Appropriate correction is required.
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, 15-17 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.
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 1,4), 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) but 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 and Hojeibane above, Boucek discloses the SMA wire 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 and Hojeibane above, Boucek discloses the SMA frame is inward sloping toward the at least one central aperture (figure 4).
As to claim 5, with the device of Boucek 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 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 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 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 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 and Hojeibane above, Hojeibane further teaches the thermoplastic layer is polytetrafluoroethylene (PTFE) (paragraph 37, 87).
As to claim 13, Boucek 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 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 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 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).
Claims 9, 12 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 as applied to claims 1-8, 10, 11, 13, 15-17 above, and further in view of U.S. Patent Publication 2015/0142103 to Vidlund.
As to claim 9, with the device of Boucek 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 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.
As to claim 12, Boucek as modified by Hojeibane discloses the device above but is silent about the at least one wire anchor coupled to an outer circumference of the SMA metal frame.
Vidlund teaches a similar device having at least one wire anchor (270, figure 3, paragraph 388) coupled to an outer circumference of the SMA metal frame for the purpose of providing an alternative structure to integrate an attachment structure to a delivery device to an implant. Using anchor wires in the device of Boucek and Hojeibane can use an alternative mechanism which can attach the screw mechanism to the frame. 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 and Hojeibane in order to substitute a mechanism to attach the screw mechanism to the frame.
Claims 14 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 as applied to claims 1-8, 10, 11, 13, 15-17 above, and further in view of U.S. Patent Publication 2003/0171772 to Amplatz.
As to claim 14, Boucek as modified by 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 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.
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, U.S. Patent Publication 2003/0130680 to Russel, U.S. Patent Publication 2012/0109179 to Murphy, U.S. Patent Publication 2013/0138138 to Clark, U.S. Patent Publication 2014/0371778 to Rudakov, U.S. Patent Publication 2017/0215885 to Goldie, U.S. Patent Publication 2017/0325930 to Montgomery, U.S. Patent Publication 20190183629 to Karavany, and U.S. Patent Publication 2026/0020856 to Cooper all disclose similar devices capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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