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].
Claim 2 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 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.
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.
Allowable Subject Matter
Claims 10-18 are allowed.
Claims 19-21 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.
Response to Arguments
Applicant's arguments filed June 22, 2026 with respect to claims 1-5 and 6-9 have been fully considered but they are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, under MPEP 2143(I)(B), simple substitution of one known element for another to obtain predictable results is a proper rationale for determining obviousness. Providing either a full cadaver or a partial cadaver for various anatomical training procedures is well-known in the art, as shown for example by Reich. The use of a partial cadaver in the system and method of Fernandez does not have any substantial effect on its operation. such that it would yield any unpredictable results which would weigh against obviousness.
Applicant is also advised that In response to applicant's argument that Reich does not provide any teaching for precenting blood spillage in conjunction with a partial cadaver, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). One of ordinary skill in the art, given the knowledge of the existence of partial cadavers in training settings, would understand how to properly configure the partial cadaver for a particular use. Further, the claim language “partial cadaver” is sufficiently broad that any missing portion of a cadaver would read on the claim language, even id the missing portion is not one that directly affects blood flow. As a result, it remains the Examiner’s position that the combination of references is proper, and that the invention of claims 1-5 and 7-9 is obvious under the combined teachings of the references.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Vasat can be reached at 571-270-7625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KURT FERNSTROM/Primary Examiner, Art Unit 3715
September 8, 2026
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