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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on 11/7/25 is acknowledged. Claims 20-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Graybill et al. 2017/0325940. Current claims 1 and 17 recites:
“1. (Original) A method of preparing an implantable material comprising: obtaining a target configuration for a biological valve; obtaining one or more characteristics of the biological valve to be reconstructed; obtaining one or more mechanical characteristics of the implantable material; and determining, based at least in part on the target configuration, the one or more biological valve characteristics, and the one or more mechanical characteristics of the implantable material, a pattern for the implantable material configured to reconstruct the biological valve.
Graybill et al. discloses a method of preparing an implantable material (To help reconstruct/fabricate and surgically implant valve leaflets, a temporary disposable scaffold/fixture is provided. An injected molded polymer based material forms a three dimensional scaffold to help hold individual leaflets in place for pre-assembly (i.e., stitching the leaflets together in a desired configuration), para.0012; to allow a surgeon to sew together the corners of adjacent leaflets to form a 3D valve which can later be transferred into the patient for implantation, para.0038) comprising: obtaining a target configuration for a biological valve (To help reconstruct/fabricate and surgically implant valve leaflets, a temporary disposable scaffold/fixture is provided. An injected molded polymer based material forms a three dimensional scaffold to help hold individual leaflets in place for pre-assembly i.e., stitching the leaflets together in a desired configuration [i.e. target configuration], para.0012; the leaflets attached in a configuration to function as an aortic valve [i.e. biological valve] as known in the art, para.0033); obtaining one or more characteristics of the biological valve to be reconstructed (Commissure-to-commissure distances of the dissected aorta are sized with gages to determine what size individual leaflets will be required for reconstruction, para.0007; (Regarding the formation of leaflets for use on the scaffolds, thin tissue sheet(s) may be excised from the pericardium tissue having a desired thickness. Then, a desired shape for each leaflet is cut, usually with the help of a template of a chosen size, para.0040; the leaflets attached in a configuration to function as an aortic valve [i.e. biological valve] as known in the art, para.0033); obtaining one or more mechanical characteristics of the implantable material (To help reconstruct/fabricate and surgically implant valve leaflets, a temporary disposable scaffold/fixture is provided. An injected molded polymer based material forms a three dimensional scaffold to help hold individual leaflets in place for pre-assembly (i.e., stitching the leaflets together in a desired configuration), para.0012; A base ring 41 allows scaffold 40 to be free-standing on a convenient surface outside the patient to allow a surgeon to sew together the corners of adjacent leaflets to form a 3D valve which can later be transferred into the patient for implantation, para.0038; Regarding the formation of leaflets for use on the scaffolds, thin tissue sheet(s) may be excised from the pericardium tissue having a desired thickness. Then, a desired shape for each leaflet is cut, usually with the help of a template of a chosen size, para.0040); and determining, based at least in part on the target configuration, the one or more biological valve characteristics, and the one or more mechanical characteristics of the implantable material, a pattern for the implantable material! configured to reconstruct the biological valve (An injected molded polymer based material forms a three dimensional scaffold to help hold individual leaflets in place for pre-assembly (i.e., stitching the leaflets together in a desired configuration), para.0012; the leaflets attached in a configuration to function as an aortic valve, para.0033; A base ring 41 allows scaffold 40 to be free-standing on a convenient surface outside the patient to allow a surgeon to sew together the corners of adjacent leaflets to form a 3D valve which can later be transferred into the patient for implantation, para.0038; Regarding the formation of leaflets for use on the scaffolds, thin tissue sheet(s) may be excised from the pericardium tissue having a desired thickness. Then, a desired shape for each leaflet is cut, usually with the help of a template of a chosen size. A desired pattern is traced onto the tissue (e.g., with a biocompatible marking pen) and then cut out using scissors, para.0040; FIG. 16 shows a first pattern A for creating a unified leaflet set with particular leaflet sizes at particular positions in the set, para.0045; procedure for fabrication of a total biological valve reconstruction, para.0004).
Regarding Claim 2, Graybill et al. discloses the method of claim 1, wherein obtaining a target configuration for the biological valve includes obtaining a target size and/or shape of the implantable material (An injected molded polymer based material forms a three dimensional scaffold to help hold individual leaflets in place for pre-assembly i.e. stitching the leaflets together in a desired configuration, para.0012; a cutting tool for excising leaflets from a pericardial tissue sheet according to predetermined sizes and shapes, Abstract; to allow a surgeon to sew together the corners of adjacent leaflets to form a 3D valve which can later be transferred into the patient for implantation, para.0038; select a cutting block that provides the desired size and arrangement of leaflets needed to match the anatomy of a particular patient, para.0045).
Regarding Claim 3, Graybill et al. discloses the method of any one of claims 1-2, further including cutting the implantable material into the determined pattern (A plate 60 has a plurality of patterned openings 61-63 with respective sizes and/or shapes of the type useful for valve reconstruction. A desired pattern is traced onto the tissue (e.g., with a biocompatible marking pen) and then cut out using scissors, para.0040; a cutting tool for excising leaflets from a pericardial tissue sheet, wherein a leaflet having a desired contour and size is obtained by pressing the tool against the sheet, para.0015).
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.
Claim 5, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Graybill et al. 2017/0325940 in view Mortier 2015/0112659.
Graybill et al. has been disclosed supra however does not specify that measuring one or more characteristics of the biological valve to be reconstructed includes constructing a three-dimensional model of the biological valve. Mortier teaches that anatomical models of heart valves may be estimated based on 3D cardiac medical image dated (e.g. see [0033]). It would have been obvious to one having skill in the art to modify the invention of Graybill et al. and provide 3d modeling and measuring in order to provide more precise valve sizing and positioning.
Claim(s) 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Graybill et al. 2017/0325940 in view of Righini et al. 2016/0346080.
Regarding Claim 11, Graybill et al. discloses the method of claim 1, but fails to explicitly disclose wherein the implantable material is anisotropic. Righini et al. is in the field of implanting prosthetic device for a heart valve (Abstract) and teaches wherein the implantable material is anisotropic (during implantation procedure the containment portion 24 of the prosthetic device, already deployed in the ventricular chamber, has to fit substantially with the ventricular aspect of the annulus of the native valve, para.0071; geometry of prosthetic leaflets vary, with a considerable degree of freedom, the rigidity to flexion of the containment portion, also creating cross sections with anisotropic elastic characteristics, while still meeting the essential requirement of longitudinal non-extendibility of the portion itself, para.0073; there is a containment portion 32 the flexional pliability of which, while still being anisotropic in each cross section, increases by distancing itself
from the portions of continuity with the connecting elements 20 until it is at its maximum close to the median region, para.0075).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Graybill et al. with anisotropic material of Righini et al. for the purpose of achieving desired elastic behavior by incorporating anisotropic material or characteristics (para.0073, 0104, Righini et al.)
Regarding Claim 14, Greybill et al. discloses the method of claim 1, but fails to explicitly disclose wherein the biological valve is anisotropic.
Righini et al.is in the field of implanting prosthetic device for a heart valve (Abstract) and teaches wherein the biological valve is anisotropic (during implantation procedure the containment portion 24 of the prosthetic device, already deployed in the ventricular chamber, has to fit substantially with the ventricular aspect of the annulus of the native valve [i.e. biological valve], para.0071; geometry of prosthetic leaflets vary, with a considerable degree of freedom, the rigidity to flexion of the containment portion, also creating cross sections with anisotropic elastic characteristics, while still meeting the essential requirement of longitudinal non-extendibility of the portion itself, para.0073; there is a containment portion 32 the flexional pliability of which, while still being anisotropic in each cross section, increases by distancing itself from the portions of continuity with the connecting elements 20 until it is at its maximum close to the median region, para.0075).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Graybill et al. with anisotropic material of Righini et al. for the purpose of achieving desired elastic behavior by incorporating anisotropic material or characteristics (para.0073, 0104, Righini et al.).
Allowable Subject Matter
Claims 4, 6, 8-16, 18-19 are 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: The subject matter of claims 4, 6, 8-16, 18-19 (e.g. measuring in a resting configuration; obtaining a stress-strain relationship of he biological valve; relating a force per unit cross-section of implantable material to measure of an average normalized to a size of the implant; utilizing an anisotropic material; stress-strain measurements in two or more different directions etc.) in combination with independent claim 1 are novel over prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 November 26, 2025