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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-17, 19, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Seiss et al (US 2019/0083690 A1, hereinafter “Seiss”).
Regarding claim 1, Seiss discloses a catheter blood pump (figure 1), comprising: a blood conduit defining a lumen and having a first end and a second end, wherein the first end is at an inflow region of the blood conduit and the second end is at an outflow region of the blood conduit (par 0013); an impeller positioned at least partially within the lumen of the blood conduit and configured to move blood from the inflow region toward the outflow region (par 0013, see figure 1); a plurality of struts extending from the first end or the second end of the blood conduit (par 0016, see figures 2C-D); and a pressure transducer positioned between two adjacent struts in the inflow region or the outflow region of the blood conduit (see figure 2C, par 0017-0019).
Regarding claim 2, Seiss discloses the pressure sensor transducer has a pressure sensitive face facing outward relative to a long axis of catheter blood pump (see figure 2C, par 0017).
Regarding claim 3, Seiss discloses the pressure transducer has a pressure sensitive face oriented non-orthogonally relative to a long axis of the catheter pump (par 0017).
Regarding claim 4, Seiss discloses a pressure sensor housing in which the pressure transducer is securely disposed (par 0019).
Regarding claim 5, Seiss discloses the pressure sensor housing includes a proximal opening sized and configured to receive a pressure sensor wire coupled to the pressure transducer (par 0019).
Regarding claim 6, Seiss discloses a pressure sensor wire extending proximally from the pressure transducer (par 0019).
Regarding claim 7, Seiss discloses the outflow region is at a proximal end of the blood conduit, wherein the plurality of struts extend in a proximal direction relative to the blood conduit (par 0013, 0017-0019, see figure 1).
Regarding claim 8, Seiss discloses proximal ends of the plurality of struts are coupled to a hub of the catheter blood pump (par 0013, 0017-0019, see figure 1).
Regarding claim 9, Seiss discloses the inflow region is at a distal end of the blood conduit, wherein the plurality of struts extend in a distal direction relative to the blood conduit (par 0013, 0017-0019, see figure 1).
Regarding claim 10, Seiss discloses distal ends of the plurality of struts are coupled to a central hub of the catheter blood pump (see figure 1).
Regarding claim 11, Seiss discloses the catheter blood pump includes a proximal pressure transducer in the outflow region and a distal pressure transducer in the inflow region (see figure 2C, par 0017-0019).
Regarding claim 12, Seiss discloses a first wire electrically coupled to the proximal pressure transducer and a second wire electrically coupled to the distal pressure transducer (par 0017-0018).
Regarding claim 13, Seiss discloses the first wire and the second wire extend together at a junction region, wherein the junction region is proximally located with respect to the blood conduit (par 0013, as shown in figure 1).
Regarding claim 14, Seiss discloses the junction region is proximally located with respect to the proximal pressure sensor (par 0013, as shown in figures 1 and 2C/D).
Regarding claim 15, Seiss discloses the plurality of struts are expandable and collapsible (pars 0020-0021).
Regarding claim 16, Seiss discloses the blood conduit is expandable and collapsible (par 0013, figure 1; where Examiner interprets the blood conduit to be capable of expansion and collapsing).
Regarding claim 17, Seiss discloses the impeller is expandable and collapsible (par 0013, figure 1; where Examiner interprets the impeller to be capable of expansion and collapsing).
Regarding claim 19, Seiss discloses the inflow region includes a distal end of the blood conduit and the outflow region includes a proximal end of the blood conduit (par 0013, 0017-0019).
Regarding claim 20, Seiss discloses the pressure transducer is positioned circumferentially between the two adjacent struts of the plurality of struts, optionally circumferentially between feet (or axially extending regions) of the two adjacent struts (see figure 2C, par 0017-0019).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Seiss in view of Salahieh et al (US 2019/0143018 A1, hereinafter “Salahieh”).
Regarding claim 18, Seiss discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose a second impeller positioned at least partially within a blood conduit. Salahieh is analogous art in regard to known alternative intravascular pump arrangements (abstract). Salahieh discloses it was known in the art to provide a second impeller positioned at least partially within a blood conduit (par 0055, see figure 2 elements 1116 and 1118. Applied to the invention of Seiss, the features of Salahieh would provide means for including a second impeller positioned at least partially within the blood conduit as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Salahieh in the invention of Seiss, since such a modification would provide the predictable results of improved blood pumps for treating compromised cardiac blood flow while maintaining a smaller size to facilitate less invasive percutaneous delivery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799 4/3/2026
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