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 2-10) in the reply filed on 12/16/25 is acknowledged. Claims 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 § 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) 2-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fish et al. 9,737,400 in view of Blum et al. 2013/0013086.
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Fig. 8D
Regarding claims 2, 5, and 8 and noting for example figures figure 8D-9E, Fish et al. discloses a tri-tube valve (730 a-c), comprising: a body comprising a first end (as shown in Fig. 8D, derived from fig. 8d), a second end (as shown in fig. 8D as marked-up), an outer surface (761 and 771, fig. 7i), and an annular region, and defining a longitudinal axis (730), the body comprising three tubular members aligned with the longitudinal axis (730 a-c); wherein each tubular member is fixedly attached to an adjacent tubular member along an adjoining exterior surface in a direction along the longitudinal axis (See mark-up Fig. 8D) such that portions of the exterior surface of the adjoined tubular members circumferentially form a wall of the body (see col 21:36-41; fig. 7); wherein each tubular member is fixedly closed at the second end (col. 26:36-41); fig. 7i), a luminal surface of each tubular member defining a top surface of a leaflet (720, fig.7f), wherein the portions (711; 721) of the exterior surface at the first end of the adjoined tubular members that do not form the wall of the body define commissures (716; 726), wherein each leaflet comprising a commissure region (716; 726; fig. 7h) and a contiguous annulus region are formed by each tubular member (fig. 8D).
However, Fish does not disclose that the prosthesis is decellularized. Blum et al. teaches the prosthetic tubular implants may be made of decellularized tissue (see [0028]). It would have been obvious to one having ordinary skill in the art to modify the invention of Fish et al. and utilize decellularized tissue for the tubular implant because Fish envisions the use of biocompatible membrane material (see 4:49-50 and 11:41-48) and decellularized extracellular matrix constructs are designed to allow host cells to infiltrate, permeate or otherwise associate with the scaffold.
Regarding claims 3, 6, and 9 see Fig. 1E and 15:22-36 for forming the commissures and see regions (716 and 726). Regarding claims 4, 7 and 10, Fish disclose that the device is useful for aortic valves however does not limit the type of valve that may be addressed (see for example 2:21-29).
Conclusion
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 January 8, 2026
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