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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (US 2016/0140878) in view of Reich. Fernandez discloses in the Figures and specification a testing system (see paragraph [0050]) comprising a pump, a heart valve, a vessel, a fluid and a cadaveric tissue (all disclosed at paragraph [0022]), where the vessel is in fluidic connection with the pump and the cadaveric tissue. Fernandez does not disclose the provision of a partial cadaver. This feature is known in the art, as taught for example by Reich at paragraph [0169], and would have been obvious to one of ordinary skill in the art as an obvious substitution of one known element for another to achieve predictable results and for the purpose of providing a more portable testing system.
With respect to claim 3, Fernandez discloses at paragraph [0025] the provision of a pulsatile pump. With respect to claim 5, Fernandez further discloses the provision of a cadaveric artery. With respect to claim 7, the heart valve of Fernandez is located within a vessel. With respect to claim 8, Fernandez discloses the provision of a full cadaver, which includes each of the recited cadaveric tissue types. With respect to claim 9, Fernandez discloses the use of expired blood at paragraph [0049].
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (US 2016/0140878) in view of Reich, and further in view of Alkhatib. Fernandez teaches or suggests the claim limitations with the exception of the provision of a synthetic aorta valve as recited. This feature is known in the art, as taught for example by Alkhatib at paragraphs [0006] and [0027-28], and would have been obvious to one of ordinary skill in the art as an obvious substitution of one known element for another to achieve predictable results and for the purpose of facilitating testing of an implantable heart valve. With respect to claim 6, Alkhatib further discloses at paragraphs [0006] and [0027-28] the provision of a synthetic tube.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (US 2016/0140878) in view of Reich, and further in view of Lemieux. This feature is known in the art, as taught for example by Lemieux at paragraph [0042], and would have been obvious to one of ordinary skill in the art as an obvious substitution of one known element for another to achieve predictable results
Claims 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (US 2016/0140878) in view of Alkhatib. With respect to claim 10, Fernandez teaches or suggests the claim limitations with the exception of the provision of an implantable medical device as recited. This feature is known in the art, as taught for example by Alkhatib at paragraphs [0006] and [0027-28], and would have been obvious to one of ordinary skill in the art as an obvious substitution of one known element for another to achieve predictable results and for the purpose of facilitating testing of an implantable medical device. With respect to claim 11, Fernandez discloses the use of expired blood at paragraph [0049]. With respect to claim 12, Fernandez discloses the step of controlling the temperature of the fluid at paragraph [0038]. With respect to claim 13, Fernandez discloses the step of controlling the temperature of the fluid at paragraph [0026]. With respect to claim 14, Alkhatib discloses the step of causing fluid to flow through a tubular vessel in communication with the implantable medical device. With respect to claim 15, Fernandez discloses the provision of a full cadaver, which includes each of the recited cadaveric tissue types. With respect to claim 16, Fernandez discloses the provision of a natural blood vessel. With respect to claims 17 and 18, Alkhatib discloses at paragraphs [0006] and [0027-28] that its implantable medical device is in one embodiment an artificial aorta valve.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KURT FERNSTROM whose telephone number is (571)272-4422. The examiner can normally be reached M-F 10-6.
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/KURT FERNSTROM/Primary Examiner, Art Unit 3715
February 11, 2026
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