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 .
Allowable Subject Matter
Claims 1-4 are allowed.
The following is an examiner’s statement of reasons for allowance: The closest prior art of record is O’Hare et al (2014/0207250) which teaches, “the scaffold may be constructed of alternating layers of aligned and randomly oriented fibers”; see abstract. This fails to teach the claim limitation that the non-aligned (random) fibers are simultaneously electrospun with the aligned fibers. Further, O’Hare et al fails to teach producing circumferentially aligned bands.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 5, 7-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Badhwar et al (11,129,711).
Badhwar et al teaches a heart valve comprising at least one leaflet (i.e. bileaflet shown);
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wherein a free edge of the leaflet (depicted) consists essentially of a circumferentially aligned band of aligned electrospun fibers with non-aligned fibers. Badhwar et al teaches 19:46-52:
In further detail and with regard to rotating mandrels, an anisotropic matrix, that is a matrix or article in which at least a portion of which is anisotropic, is prepared by electrospinning on a mandrel, by biasing fiber deposition away from a random, isotropic orientation, resulting in a non-random bias of fiber orientation in a specific orientation, for example with a circumferential bias (interpreted as a circumferentially aligned band). “At least a portion of which is anisotropic” is interpreted that some are non-anisotropic, non-aligned.
Badhwar et al further states (26:18-21), the “fibers are at least partially deposited and aligned in a circumferential direction in at least one portion of the heart valve, for example in the concave portion, or the bellies of the leaflet”. The examiner interprets this as some fibers are not aligned in the circumferential direction and can be on any portion of the leaflet including the free edge.
Wherein the aligned fibers are bioabsorbable polymer fibers and wherein the non-aligned fibers are bioabsorbable polymer fibers; see at least column 12, line 49-67.
Inherently, at least one of the following is true: wherein the aligned fibers and the non-aligned fibers at the free edge are either distinct layers or intermixed.
Claims 7 and 10, the bioabsorbable polymer fibers of both the aligned fibers and non-aligned fibers inherently degrade allowing infiltration of cells replacing said fibers over time with newly formed tissue. See at least 8:64 teaching tissue remodeling.
Claims 8, requires the leaflet belly area consists essentially of a circumferentially aligned band of aligned electrospun fibers with non-aligned fibers. The main rejection above describes the belly area fulfilling this limitation.
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.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Badhwar et al (11,129,711) in view of Serrero et al (2019/021588).
Badhwar et al teaches a heart valve comprising at least one leaflet as described above, however, fails to teach wherein the bioabsorbable polymer fibers of the aligned fibers are supramolecular bioabsorbable polymer fibers and/or wherein the bioabsorbable polymer fibers of the non-aligned fibers are supramolecular bioabsorbable polymer fibers.
Serrero et al also teaches a biodegradable heart valve (see figures 3A-C) comprising bioabsorbable electrospun fibers, either aligned or random (figure 2), wherein the bioabsorbable polymer fibers of the aligned fibers are supramolecular bioabsorbable polymer fibers and/or wherein the bioabsorbable polymer fibers of the non-aligned fibers are supramolecular bioabsorbable polymer fibers; see at least the abstract.
It would have been obvious to one having ordinary skill in the art to have used supramolecular bioabsorbable polymer fibers as taught by Serrero et al for either one or both of the aligned fibers bioabsorbable polymer fibers and/or the non-aligned fibers of Badhwar et al resulting in leaflets with much enhanced durability and fatigue resistance, while maintaining the effectiveness as a leaflet.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774