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
Claims 1-3, 5, 6 and 10-12 are objected to under 37 CFR 1.75 as being a substantial duplicates of claims 13-20, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Examiner’s Note
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Biadillah et al. (US PG Pub. 2014/0018915), hereinafter Biadillah, in view of Fish et al. (US PG Pub. 2011/0301700), hereinafter Fish, and Rzany et al. (US PG Pub. 2017/0119928), hereinafter Rzany.
Regarding claims 1-5, 7, 8, 11-16, 19 and 20, Biadillah discloses a method of making an implantable prosthetic valve (15), illustrated in Figures 1-3, comprising inserting valve leaflet tabs (30) into commissural slots (19) of a valve frame (20); and further comprising cutting away at least a portion of, and/or attaching, the valve leaflet tabs (30) to the valve frame (20), illustrated in Figures 1-4a and 5d ([0103], Lines 1-2, 8; [0104], Lines 1-2; [0105], Lines 1-2; [0106], Lines 4-6; [0108], Lines 10-14; [0109], Lines 6-8; [0110], Lines 1-12 & [0111], Lines 34-40); but does not specifically disclose compressing at least a portion of valve leaflet tabs before inserting the compressed valve leaflet tabs and expanding the compressed valve leaflet tabs.
However, Fish teaches a method of making an implantable prosthetic valve, in the same field of endeavor, wherein the leaflet tissue is treated with an aqueous/liquid glutaraldehyde solution to prepare/fix biologic tissue material and then subsequently compressed, i.e. dried/at least 50% of the liquid is removing, while applying pressure/force between a set of plates, and then assembling the leaflet tissue with a frame; the preparing/fixing step allows biologic tissue material to be suitable for implantation and the compressing/drying step allows for a low profile valve implant which can be mounted to a delivery catheter and packaged as an integrated delivery system without needing to be stored/transported in preservative, saving time during the surgical procedure (Fish: [0008], Lines 10-13; [0104], Lines 5-7; [0117]; [0118]; [0124]; [0126], Lines 15-21 & [0142]). Furthermore, Rzany teaches that rehydrating a dried prosthetic valve aids in sealing gaps/preventing paravalvular leakage due to the expansion/increase in thickness of the valve tissue (Rzany: [0016] & [0034]).
In view of the teachings of Fish and Rzany, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the method of making an implantable prosthetic valve, of Biadillah, to further include the steps of preparing/fixing the biologic material of the leaflets with an aqueous/liquid glutaraldehyde solution, in order to make the material suitable for implantation, and subsequently compressing the leaflet material/leaflet tabs by drying/removing at least 50% of the liquid solution while applying pressure/force, to the leaflet material/leaflet tabs, between a set of plates, in order to allow the valve to a low profile implant which can be mounted to a delivery catheter and packaged as an integrated delivery system without needing to be stored/transported in preservative, saving time during the surgical procedure, as taught by Fish; and to further expand the compressed leaflet material/leaflet tabs, by rehydrating a dried valve, in order to aid in sealing gaps/preventing paravalvular leakage due to the expansion/increase in thickness of the leaflet material/leaflet tabs, as taught by Rzany.
Regarding claims 6 and 17, Biadillah in view of Fish and Rzany disclose the method of making an implantable prosthetic valve of claims 1 and 13, and though it is not specifically disclosed that compressing at least a portion of valve leaflet tabs comprises reducing a thickness of the valve leaflet tabs by at least 50% of a starting thickness, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate reduced thickness, including reduced by at least 50% of a starting thickness, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (see MPEP 2144.05). Furthermore, neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of compressing comprising reducing the thickness by at least 50% of a starting thickness, as opposed to reducing it by any other number/percentage.
Regarding claim 9, Biadillah in view of Fish and Rzany disclose the method of making an implantable prosthetic valve of claim 8, and though it is not specifically disclosed that the set of plates comprise one or more surface channels and/or one or more apertures, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate surface for the set of plates, including having surface channels and/or apertures, since doing to amounts to a mere change in the shape of the surface of the plates, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Furthermore, neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the plates comprising one or more surface channels and/or one or more apertures, as opposed to having any other type of surface.
Regarding claims 10 and 18, Biadillah in view of Fish and Rzany disclose the method of making an implantable prosthetic valve of claims 7 and 13, and though it is not specifically disclosed that the compressing/applying pressure to the valve leaflet tabs comprises applying at least 5 lbf force for at least 5 minutes, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate force and time to apply the pressure, including at least 5 lbf force for at least 5 minutes, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (see MPEP 2144.05). Furthermore, neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the pressure being applied with at least 5 lbf force for at least 5 minutes, as opposed to any other force and/or any other time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 09/25/2026
