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 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. 3. Claim (s) 2 - 6 are rejected under 35 U.S.C. 103 as being unpatentable over Millwee et al. 2010/0011564 in view of Rottenberg et al. 6,165,215 . Regarding claim 2 and n oting fig. 25 supra, Millwee et al. discloses a method for fabricating a leaflet for a prosthetic heart valve, the method comprising: layering a sheet of a leaflet material over a first mold portion having a first leaflet form, the sheet having a uniform thickness ; and applying a second mold portion to the sheet, the second mold portion having a second leaflet form different from the first leaflet form (see [0049] which states: “…FIG. 25 illustrates a mold 250 for a leaflet in its closed position, wherein the contours of the top surface of a mold 256 follow that of a leaflet belly. This mold is made to sit on top of first layer of pericardial tissue (outer tube wall), where it is locked into place. A second layer of pericardium (the leaflet layer) can then be placed over the leaflet mold . An additional mold shaped as the negative of the inflow region can also be provided such that the contours of its top surface follow that of the leaflet margin of attachment. This template is made to sit on top of the second layer of pericardial tissue (leaflet) and locked into place.”) , wherein the second mold portion pushes the sheet against ( the molds are being “pushed” together because they are locked into place ) the first leaflet form to form the sheet into a sheet. However , Millwee et al. does not specifically state that the sheets have a non-uniform thickness. Rottenberg et al. teaches that heart valve leaflets may be produced having non-uniform thickness (see 2:21-23). It would have been obvious to one having ordinary skill in the art to modify the invention of Millwee et al. to produce leaflets with non-uniform leaflets because plate molds that have thicknesses that vary at least somewhat across the length and/or width and would provide superior flexibility, so as to open with minimal pressure and close with reduced turbulence and minimal hemolysis. 4. Regarding claim 3 Millwee et al. discloses the use of pericardial tissue as disclosed supra. 5. Regarding claim 4 , Millwee et al. discloses that the tissue may be fixed such as using a glutaraldehyde solution (see [0050]). 6. Regarding claims 5 and 6 “wherein the fixing step is performed before the layering step ” and “wherein the fixing step is performed while the second mold portion pushes the sheet against the first leaflet form” Millwee et al. discloses in [0050] “…. The entire valve can then be fixed, such as in a glutaraldehyde solution, with the leaflet molds in place to maintain the shape of the leaflets. The molds can then be removed and the valve can be attached to a stent, if desired. Alternatively , the valve will not be fixed until after it is attached to a stent … .” 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 Millwee et al. to perform the fixing step before the layering the step and/or perform the fixing step while the second mold portion pushes the sheet against the first leaflet form” because Millwee et al. does not limit the process as to when the fixation of the leaflets may occur. Allowable Subject Matter 7. Claim 7 is 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. 8. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of Millwee et al. 2010/0011564 in view of Rottenberg et al. 6,165,215 has been explained supra. This prior art fails to teach or disclose that the does not teach or disclose the methods of the applying step is performed for between about 10 minutes and about 48 hours . 9. Claims 8-12 are allowed. 10. The following is an examiner’s statement of reasons for allowance: The closest prior art is considered to be Millwee et al. 2010/0011564 as described supra which teaches the methods of fabricating a leaflet for a prosthetic heart valve using layered sheets of tissue material and molds. The prior art fails to teach or disclose the methods of providing a sheet having a first major surface, a second major surface, and a first thickness between the first major surface and the second major surface; positioning a first plate adjacent to the first major surface and a second plate adjacent to the second major surface so that a distance between the first plate and the second plate defines a desired sheet thickness greater than the first thickness; and moving opposed edges of the sheet toward one another between the first plate and the second plate to force the sheet against the first plate and the second plate to increase the thickness of the sheet to the desired thickness. 11. 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.” Conclusion 12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272- 4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:/Avww.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https:/Awww.uspto.gov/patents/apply/patent- center for more information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 . /SUZETTE J GHERBI/ Primary Examiner, Art Unit 3774 March 19, 2026