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
2. Applicant’s election without traverse of Group I and Species B, (corresponding to claims 1-3 and 5-8), in the reply filed on 3/5/2026 is acknowledged.
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 1-3 and 5-8 are rejected under 35 U.S.C 103 as being unpatentable over Schumacher et al. (US Pub.: 2015/0343179 A1) and further in view of Suzuki et al. (US Patent No.: 4,682,981).
Regarding claim 1, Schumacher teaches a mechanical circulatory support system, comprising:
a circulatory support catheter, comprising a circulatory support device carried by an elongate flexible catheter shaft (e.g. Fig. 4; paragraph 0064, distal pump unit 31 is circulatory support device, flexible catheter shaft, flexible catheter shaft extends inside shaft catheter 32)
the circulatory support device comprising a tubular housing, a motor, and an impeller configured to be rotated by the motor (e.g. paragraphs 0064-0065, – rotor 35 is the impeller, drive unit is the motor, pump housing 33);
an insertion tool having a tubular body and configured to axially movably receive the circulatory support device (e.g. paragraph 0072, – distal pump unit 31’ is retracted into lumen of second sheath 20’ by pulling shaft of catheter 32’ proximally);
an introducer sheath, having a tubular body and configured to axially movably receive the insertion tool (e.g. paragraph 0077, – second sheath 20’, an auxiliary sheath, is inserted with its distal end into the sheath housing of the first sheath 10, an introduction sheath);
and a coupling configured to couple the insertion tool and introducer sheath (e.g. paragraphs 0062, 0064).
However, Schumacher does not explicitly teach that the coupling is a hexagonal coupling.
Suzuki, in a same field of endeavor of catheters, discloses that the coupling is a hexagonal coupling (e.g. Fig. 9 – fitting portions 10 and 11; column 3, lines 49-52).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanical circulatory support system of Schumacher to incorporate a hexagonal coupling, as taught and suggested by Suzuki, in order to ensure a secure connection by preventing unwanted rotational movement (Suzuki, column 3, lines 52-55).
Regarding claim 2, Schumacher in view of Suzuki teaches the mechanical circulatory support system of claim 1 as discussed above, and Suzuki further teaches wherein the hexagonal coupling comprises a male mating part configured to couple with the insertion tool and a female mating part configured to couple with the introducer sheath (e.g. column 3, lines 49-51).
Regarding claim 3, Schumacher in view of Suzuki teaches the mechanical circulatory support system of claim 2 as discussed above, and Suzuki further teaches wherein the male mating part comprises a hexagonal distal portion (e.g. column 4, lines 49-53).
Regarding claim 5, Schumacher in view of Suzuki teaches the mechanical circulatory support system of claim 3 as discussed above, and Suzuki further teaches wherein the hexagonal distal portion comprises an indent portion extending circumferentially around the hexagonal distal portion approximately halfway along a longitudinal axis of the hexagonal distal portion (e.g. column 3 lines 16-19; column 4, lines 34-37).
Regarding claim 6, Schumacher in view of Suzuki teaches the mechanical circulatory support system of claim 3 as discussed above, and Suzuki further teaches wherein the hexagonal distal portion of the male mating part is configured to mate with a hexagonal receiving portion of the female mating part (e.g. column 3, lines 49-52).
Regarding claim 7, Schumacher in view of Suzuki teaches the mechanical circulatory support system of claim 2 as discussed above, and Suzuki further teaches wherein the female mating part comprises a hexagonal receiving portion configured to self-align the male mating part with the female mating part in response to a force applied along an axial direction (e.g. column 4, lines 34-40).
Regarding claim 8, Schumacher in view of Suzuki teaches the mechanical circulatory support system of claim 1 as discussed above, and Suzuki further teaches wherein the hexagonal coupling is configured to provide haptic feedback when the insertion tool is coupled with the introducer sheath (e.g. column 3, lines 43-47).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
