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’s arguments with respect to claim(s) 4/22/26 have been considered but are moot because the new ground of rejection does not rely on all of the references applied in the prior rejection of record.
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(s) 1-3, 8, 14, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Graybill et al. 2017/0325940 in view of Cao et al. 20070208550.
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, wherein the implantable material is anisotropic.”
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).
However Graybill et al. does not specify that the implantable material is anisotropic.”
According to Merriam-Webster dictionary, the term anisotropic mean exhibiting properties with different values when measured in different directions. Cao et al. teaches that materials that exhibit anisotropic properties may be utilized in the production of preparing an implantable heart valve (see [0012; 0038]). It would have been obvious to one having ordinary skill in the art at the time the invention as made to modify Graybill et al. to utilize anisotropic implantable materials in order to product a prosthesis that mimics heart material properties that are directionally dependent mechanical, electrical, and structural properties of cardiac tissue.
5. 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).
6. 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).
7. Regarding claim 8, Graybill et al. does not disclose measuring the stress-strain relationship of the implantable material. Cao teaches that materials may be measured for a stress strain relationship (see [0012; 0038; 0058]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Graybill et al. and measure the stress-strain relationship of the implantable materials in order to manufacture accurate parameters of the simulated heart valve.
8. Claim 5, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Graybill et al. 2017/0325940 in view of Cao et al. 20070208550 and further in view of 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.
Allowable Subject Matter
9. Claims 4, 6, 9-10, 12-13, 15-16, 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.
Conclusion
9. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 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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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 July 8, 2026
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