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 .
Status of Claims
Claims 1-15 are currently pending and under consideration.
Specification
The disclosure is objected to because of the following informalities:
"14provided" on page 7 should be corrected to --14 provided--;
"support recess 23" in line 6 of the last paragraph on page 9 should be corrected to --"support recess 32"--;
"second channel 68" in line 7 of the last paragraph on page 9 should be corrected to --second channel 58--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 15, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For the purpose of examination, the phrase following the limitation “in particular” has been interpreted as an optional limitation. Claims 2-14 are dependent on claim 1 and are therefore rejected for the same reason as claim 1.
Regarding claims 2, 6-8, 10, 12, and 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For the purpose of examination, the phrase following the limitation “preferably” has been interpreted as an optional limitation. Claims 3-6, 8, 11, and 12 are dependent on claims 2, 7, and 10 and are therefore rejected for the same reason as claims 2, 7, and 10.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 7-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over D'Ambrosio et al. (US 20170348470 A1, published 12/07/2017, hereinafter known as D'Ambrosio) in view of Higgins (US 20200030510 A1, published 01/30/2020).
Regarding claim 1, D’Ambrosio teaches pump housing for a blood pump comprising: a distal end portion (shown below in annotated Fig. 5) having a first blood flow opening (input port 11 in Fig. 3, [0044]); a proximal end portion (proximal end 101 in Fig. 5, [0046]); an intermediate portion extending axially between the distal end portion and the proximal end portion (shown below in annotated Fig. 5), the intermediate portion having at least one second blood flow opening (output port 125 in Fig. 5, [0053]); and a first sensor for sensing at least one parameter (sensor 1020 in Fig. 5, [0047]); wherein the first sensor is disposed on an outer peripheral surface of the intermediate portion (sensor 1020 in Fig. 5), wherein the pump housing comprises a second sensor (sensor 1020 in Fig. 5, [0047]), wherein the second sensor is disposed on the distal end portion for sensing at least one parameter (sensor 1020 in Fig. 5), in particular pressure at the first blood flow opening (“the sensor 1020 may sense blood pressure, blood flow rate, and/or other parameters” [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize two sensors as described in the claimed invention since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success.
PNG
media_image1.png
492
528
media_image1.png
Greyscale
However, D’Ambrosio does not teach that the first sensor senses aortic pressure.
Higgins teaches an intravascular blood pump comprising a pump assembly without a flow inducer or diffuser, and proximal and distal flow rate or pressure sensors, wherein the distal flow rate or pressure sensor may be tracked distal to the impeller after placement of the blood pump within the patient's vasculature (Abstract). Known solutions provide an aortic pressure measurement through a pressure sensor located proximal to the impeller pump housing assembly ([0038]). Output flow is calculated in these known devices based on the aortic pressure, the impeller rotational speed and the motor current ([0038]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the blood pump housing of D’Ambrosio with the measurement of aortic pressure of Higgins because blood pumps are typically inserted into the aorta, so this measurement is important to ensure effectiveness of the blood pump device by monitoring output flow.
Regarding claim 7, in the modified device of D’Ambrosio, D’Ambrosio teaches the pump housing further comprises a first elongated transmitting device (transmission fiber 1024 in Fig. 5, [0055]), wherein the first sensor comprises a first axial end and a second axial end (sensor 1020 is parallel to longitudinal axis as shown in annotated Fig. 5), and wherein the first elongated transmitting device is coupled to the second axial end of the first sensor (distal end of transmission fiber 1024 is coupled to second axial end of sensor 1020 as shown in annotated Fig. 5, [0066]), the first elongated transmitting device extending to the proximal end portion of the pump housing (transmission fiber 1024 extends proximally towards end 101 as shown in annotated Fig. 5.), wherein the first elongated transmitting device is preferably a cable, a fiber or an optical conductor (“in some implementations, the transmission fiber is an optical fiber” [0022]).
Regarding claim 8, in the modified device of D’Ambrosio, D’Ambrosio teaches the pump housing further comprises a first channel (strut 127 in Fig. 5, [0053]) extending between the intermediate portion and the proximal end portion of the pump housing (strut 127 in Fig. 5, [0053]), wherein the first elongated transmitting device is disposed in the first channel (“transmission fiber 1024 extends along one of the plurality of struts 127 of the blood pump housing component 103”, Fig. 5, [0055]), wherein the first channel is preferably recessed from the outer peripheral surface of the intermediate portion and an outer peripheral surface of the proximal end portion of the pump housing (“recessed in the outflow cage 400 of the blood pump housing component 103” Fig. 5, [0055]).
Regarding claim 9, in the modified device of D’Ambrosio, D’Ambrosio teaches the blood pump housing as described in claim 1, wherein the second sensor comprises a first axial end and a second axial end (sensor 1020 is parallel to longitudinal axis as shown in annotated Fig. 5).
However, D’Ambrosio does not teach the first axial end of the second sensor is flush with the first blood flow opening in a radial direction.
Higgins teaches one proximal pressure or flow rate sensor may be mounted within the blood pump sheath, a region that is generally located within the patient's aorta when operationally positioned (sensor 206 is flush with the proximal end of the blood pump sheath in Fig. 6A, [0043]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the blood pump housing of D’Ambrosio with the placement of the second sensor of Higgins because the sensor can then be in operative connection and communication with the external power source and the controller and adapted to transmit pressure or flow rate data to the controller (Higgins, [0044]).
Regarding claim 10, in the modified device of D’Ambrosio, D’Ambrosio teaches the pump housing further comprising a second elongated transmitting device (transmission fiber 1024 in Fig. 5, [0055]), wherein the second elongated transmitting device is coupled to the second axial end of the second sensor (distal end of transmission fiber 1024 is coupled to second axial end of sensor 1020 as shown in Fig. 5, [0066]), the second elongated transmitting device extending to the proximal end portion of the pump housing (transmission fiber 1024 extends proximally towards end 101 as shown in annotated Fig. 5.), wherein the second elongated transmitting device is preferably a cable, a fiber or an optical conductor (“in some implementations, the transmission fiber is an optical fiber” [0022]).
Regarding claim 11, in the modified device of D’Ambrosio, D’Ambrosio teaches the pump housing further comprises a second channel (strut 127 in Fig. 5, [0053]) extending between the distal end portion and the proximal end portion of the pump housing (strut 127 in Fig. 5, [0053]), wherein the second elongated transmitting device is disposed in the second channel (“transmission fiber 1024 extends along one of the plurality of struts 127 of the blood pump housing component 103”, Fig. 5, [0055]).
Regarding claim 14, in the modified device of D’Ambrosio, D’Ambrosio teaches the first sensor is an optical sensor and/or wherein the second sensor is an optical sensor (“the sensor is an optical sensor that transmits optical signals” [0008]).
Regarding claim 15, D’Ambrosio teaches a distal end portion (shown below in annotated Fig. 5) having a first blood flow opening (input port 11 in Fig. 3, [0044]); a proximal end portion (proximal end 101 in Fig. 5, [0046]); an intermediate portion extending axially between the distal end portion and the proximal end portion (shown below in annotated Fig. 5), the intermediate portion having at least one second blood flow opening (output port 125 in Fig. 5, [0053]); and a first sensor for sensing at least one parameter (sensor 1020 in Fig. 5, [0047]); wherein the first sensor is disposed on an outer peripheral surface of the intermediate portion (sensor 1020 in Fig. 5), wherein the pump housing comprises a second sensor (sensor 1020 in Fig. 5, [0047]), wherein the second sensor is disposed on the distal end portion for sensing at least one parameter (sensor 1020 in Fig. 5), in particular pressure at the first blood flow opening (“the sensor 1020 may sense blood pressure, blood flow rate, and/or other parameters” [0047]), wherein the blood pump is preferably a catheter pump or an intravascular blood pump (“catheter-based blood pump assembly” [0067]).
However, D’Ambrosio does not teach that the first sensor senses aortic pressure.
Higgins teaches that known solutions provide an aortic pressure measurement through a pressure sensor located proximal to the impeller pump housing assembly ([0038]) as discussed above for claim 1.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the blood pump housing of D’Ambrosio with the measurement of aortic pressure of Higgins because blood pumps are typically inserted into the aorta, so this measurement is important to ensure effectiveness of the blood pump device by monitoring output flow.
Claims 2-6, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over D'Ambrosio in view of Higgins as applied to claim 1 above, and in further view of Benkowski et al., (US 5947892 A, published 09/07/1999, hereinafter known as Benkowski).
Regarding claim 2, in the modified device of D’Ambrosio, D’Ambrosio teaches wherein the second sensor is disposed in the thickened portion
However, D’Ambrosio does not teach the distal end portion comprises a thickened portion, the thickened portion, extending radially inwardly from the distal end portion, wherein the distal end portion preferably comprises a cannula attachment portion, the thickened portion extending radially inwardly from the cannula attachment portion.
Benkowski teaches a blood pump that comprises a pump housing having a blood flow path therethrough, a blood inlet, and a blood outlet (Abstract). Downstream end 192 of the outlet housing segment has a tapered thickness (shown in Fig. 6A, Col. 3, lines 37-38). The retaining member preferably has a tapered thickness along its axial length (shown in Fig. 11A, Col. 3, lines 43-44). On the downstream side of the stator housing segment 372 is the outlet housing segment 374, preferably having a diameter substantially the same as the inlet housing segment 370. The pump will typically be implanted with an inlet cannula (shown in Fig. 11A, Col. 15, lines 24-27).
PNG
media_image2.png
322
763
media_image2.png
Greyscale
PNG
media_image3.png
271
443
media_image3.png
Greyscale
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the blood pump housing of D’Ambrosio with the thickened portion and cannula attachment of Benkowski because the materials that the rotor, rotor blades, and other components are made of need to have sufficient thickness to produce a buoyant effect (Benkowski, Col. 11, lines 8-11).
Regarding claim 3, in the modified device of D’Ambrosio, D’Ambrosio teaches the thickened portion comprises a support recess, wherein the second sensor is disposed in the support recess (“the recess is configured to be wider than the sensor so that the blood can easily flow away”, shown in Fig. 5A, [0060]).
Regarding claim 4, in the modified device of D’Ambrosio, D’Ambrosio does not teach the thickened portion tapers in the axial direction from the first blood flow opening to the intermediate portion.
Benkowski teaches the downstream end of the outlet housing segment has a tapered thickness, retaining member preferably has a tapered thickness along its axial length (shown in Fig. 11A, Col. 3, lines 40-44).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the tapered thickness of Benkowski with the blood pump housing of D’Ambrosio because it allows for reduced turbulence of the blood traveling in the axial direction (Col. 6, lines 29-33).
Regarding claim 5, in the modified device of D’Ambrosio, D’Ambrosio teaches a support member with at least two arm portions is disposed in the distal end portion, wherein one of the arm portions comprises the thickened portion (shown in Fig. 6, [0052])
.
PNG
media_image4.png
492
506
media_image4.png
Greyscale
Regarding claim 6, in the modified device of D’Ambrosio, D’Ambrosio teaches the support member (support member 110 in Fig. 6, [0044]) comprises a bearing support portion being concentric with the distal end portion (bearing support portion 113 in Fig. 6, [0044]), the arm portions being connected to the bearing support portion (as shown in annotated Fig. 6), wherein the bearing support portion preferably has an axial end facing the first blood flow opening (bearing support position 113 is facing input port 111 as shown in Figs. 3 and 6 [0044]), wherein the axial end of the bearing support portion is preferably displaced axially inwardly from the first blood flow opening into a direction of the intermediate portion (as shown in Fig. 5, [0063]).
Regarding claim 13, in the modified device of D’Ambrosio, D’Ambrosio does not teach the proximal end portion of the pump housing has a smaller diameter than the intermediate portion of the pump housing, wherein the intermediate portion of the pump housing tapers into the proximal end portion of the pump housing.
Benkowski teaches the diameter of the diffuser hub 218 at its upstream end is preferably greater than the diameter of the impeller hub 223, (shown in Fig. 6A, Col. 12, lines 29-34). Inducer hub 221 has a tapered diameter (shown in Fig. 6A, Col. 12, lines 24-28).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the smaller diameter of the proximal end and tapering of the intermediate portion of the housing of Benkowski with the blood pump housing of D’Ambrosio because this configuration permits the pump, including the stator, to be inserted entirely or nearly entirely into the left ventricle, with only the outlet end of the flow tube outside the wall of the heart (Benkowski, Col. 17, lines 15-19).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over D’Ambrosio in view of Higgins as applied to claim 1 above, and in further view of Siess et al., (US 20200330666 A1, published 10/22/2020, hereinafter known as Siess).
Regarding claim 12, in the modified device of D’Ambrosio, D’Ambrosio teaches the distal end portion of the pump housing comprises an outer peripheral surface (shown in Fig. 5) and the proximal end portion of the pump housing (shown in Fig. 5) comprises an outer peripheral surface (outflow cage 400 in Fig. 5, [0052]), wherein the second channel is recessed from the outer peripheral surfaces of the distal end portion, the intermediate portion and the proximal end portion of the pump housing (“the blood pump housing component includes a plurality of blood exhaust windows and a plurality of struts extending between the blood exhaust windows, and the blood recess is positioned in a strut of the plurality of struts in the blood pump housing component”, [0021]).
However, D’Ambrosio does not teach wherein the second channel is preferably lined with a resin, so that the second elongated transmitting device is fixed within the second channel.
Siess teaches an intravascular blood pump comprises a pump casing having a blood flow inlet and a blood flow outlet, and an impeller arranged in said pump casing so as to be rotatable about an axis of rotation (Abstract). Coil windings may be embedded in a thermally conductive matrix; the matrix may comprise an epoxy resin ([0038]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the coating of resin of Siess with the blood pump housing of D’Ambrosio because this allows for the second transmitting device to be fixed within the second channel and protection of transmitting device ([0038]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792