DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Allowable Subject Matter
Claims 3, 5, 7, 10-13 objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 3, the prior art fails to teach nor render obvious, allowing the patient to substantially recover from adjustable annuloplasty implantation before applying the rotating external magnetic field to reshape the annuloplasty ring.
Regarding Claim 5, the prior art fails to teach nor render obvious wherein applying the rotating external magnetic field to reshape the annuloplasty ring comprises: arranging an array of cylindrical magnets in a non-aligned, Halbach configuration; placing the patient in a central area of the array of cylindrical magnets; and rotating the array of cylindrical magnets at a desired frequency.
Regarding Claim 7, the prior art fails to teach nor render obvious implanting a magnetic brake near the patient's heart, wherein, in the absence of the rotating external magnetic field, the magnetic brake prevents the internal magnet from rotating.
Regarding Claim 10, the prior art fails to teach a lead screw coupled to a first end of the internal magnet, wherein the lead screw rotates with the rotating internal magnet; and a drive nut coupled to the adjustable member, wherein threads of the drive nut engage threads of the lead screw, and wherein rotation of the lead screw through the drive nut pulls or pushes the adjustable member.
Regarding Claims 11, 12, Moaddeb discloses wherein applying the rotating external magnetic field comprises applying the rotating external magnetic with an external adjustment device comprising a controller (as seen in Figure 44 and paragraph [0301]). However, the prior art does not expressly disclose a first stepper motor in communication with the controller, the first stepper motor coupled to at least a first subset of the one or more external magnets, wherein the controller is configured to control the rotation of the first stepper motor, wherein the one or more external magnets comprise an electromagnet. Claim 13 depends from claim 11.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 1-2, 4, 6, 8-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moaddeb et al. U.S. Publication 2007/0135913 A1 in view of Navia et al. 2007/0233239 A1.
Regarding Claim 1, Moaddeb et al. discloses a method for treating a heart valve (abstract and paragraphs [0013-0014], [0080]), the method comprising: implanting an adjustable annuloplasty ring 100 on or near a patient's cardiac valve annulus (paragraphs [0012-0013], [0017], [0080-0081], [0101]), the adjustable annuloplasty ring 100 comprising: a tubular body member 112 (paragraph [0124]); one or more adjustable members 114 (paragraph [0126]), the tubular body member 112 and the one or more adjustable members 114 forming a ring shape (as seen in Figures 1A-1B); and an internal magnet within the tubular body member (the tubular member has energy absorption enhancement material/ferromagnetic shape memory material that causes the diameter of the tubular member 112 to be changed by exposing the tubular member to a magnetic field (see paragraphs [0124], [0126-0127]), the internal magnet configured to rotate in response to a rotating external magnetic field (paragraphs [0015], [0017]). However, Moaddeb et al. does not expressly wherein the internal magnet is coupled to the one or more adjustable members to change a dimension of the ring shape as the internal magnet rotates. Navia et al. teaches an adjustable annuloplasty ring 14 in the same field of endeavor (abstract) comprising a tubular body comprising an internal magnet 76 coupled to one or more adjustable members 58 (see Figures 9A-12 and paragraphs [0055-0057]) for the purpose of adjusting the annuloplasty ring to be sized to the valve annulus (paragraphs [0009], [0053], [0070] and [0093]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Moaddeb's annuloplasty ring to further comprise an internal magnet coupled to the one or more adjustable members as taught by Navia et al. for the purpose of allowing the annuloplasty ring to be connected and form a natural shape that compliments the native annulus and allows the ends of the device to be mated to adjust the size of the annuloplasty ring to better conform to the size of the valve annulus.
Regarding Claim 2, Moaddeb et al. discloses applying the rotating external magnetic field to reshape the annuloplasty ring (paragraphs [0012], [0015], [0017], [0090], [0101-0102], [0104], [0221]).
Regarding Claim 4, in the embodiment used in the rejection above Figure 1A-1B of Moaddeb et al. does not expressly disclose wherein applying the rotating external magnetic field to reshape the annuloplasty ring comprises applying the external magnetic field during open heart surgery. In an alternative embodiment as seen in Figures 33-34, Moaddeb et al. teaches an annuloplasty ring in the same field of endeavor comprising a tubular body and an internal magnet 2916, 2914, wherein the magnet is activated by percutaneously delivering one or more activation magnets via magnetic tip 3214a, 3214b of a delivery catheter 3200a, 3200b during open heart procedures so that the annuloplasty device can be activated (paragraph [0246]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Figure 1A-1B of Moaddeb to further include delivery of external magnetic field during open heart surgery as taught in Figures 33-34 for the purpose of allowing the annuloplasty device to be activated and operable.
Regarding Claim 6, in the embodiment used in the rejection above Figure 1A-1B of Moaddeb et al. does not expressly disclose wherein applying the rotating external magnetic field to reshape the annuloplasty ring comprises: percutaneously delivering one or more activation magnets to a heart chamber (paragraphs [0086], [0179], [0205-0206], [0248]); and rotating the one or more activation magnets at a desired frequency. In an alternative embodiment as seen in Figures 33-34, Moaddeb et al. teaches an annuloplasty ring in the same field of endeavor comprising a tubular body and an internal magnet 2916, 2914, wherein the magnet is activated by percutaneously delivering one or more activation magnets via magnetic tip 3214a, 3214b of a delivery catheter 3200a, 3200b (paragraph [0260]) for the purpose of allowing the inner dimension of the ring to contract or shrink to alter the size of body member and change the size of the annulus of the valve (paragraph [0011], [0212]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Figure 1A-1B of Moaddeb to further include delivery one or more activation magnets percutaneously via a catheter as taught in Figures 33-34 for the purpose of allowing the inner dimension of the ring to contract or shrink to alter the size of body member and change the size of the annulus of the valve.
Regarding Claim 8, 9, in the embodiment used in the rejection above Figure 1A-1B of Moaddeb et al. does not expressly disclose wherein the internal magnet comprises a cylindrical magnet having magnetic poles divided along a plane running the length of the cylinder, wherein the internal magnet is permanent. In an alternative embodiment as seen in Figures 33-34, Moaddeb et al. teaches an annuloplasty ring in the same field of endeavor comprising a tubular body and an internal magnet 2916, 2914 in the form of a permanent magnet comprising a cylindrical magnet having magnetic poles divided along a plane running the length of the cylinder (as seen in Figure 33-34 and paragraphs [0216-0217], [0220]) for the purpose of allowing the inner dimension of the ring to contract or shrink to alter the size of body member and change the size of the annulus of the valve (paragraph [0011], [0212]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Figures 1A-1B to further include an internal magnet having a cylindrical magnet wherein the magnet is permanent and having magnetic poles as taught in Figures 33-34 for the purpose of allowing the inner dimension of the ring to contract or shrink to alter the size of body member and change the size of the annulus of the valve.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
