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 119, 120, 125, 127-130, 133-40, and 143-148 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Leschinsky (US 5,928,132).
Regarding claim 119, Leschinsky discloses a pump for assisting blood circulation (as shown in figures 11 and 12; col 6, ln 56-col 7, ln 22) comprising: a housing (col 6, ln 56-col 7, ln 22; cannula 160); and a valve member disposed within the housing (col 6, ln 56-col 7, ln 22; pumping chamber 160), the valve member comprising a flexible diaphragm coupled to a frame (col 6, ln 56-col 7, ln 22; diaphragm 127 and valves 114, 115), the frame having a collapsed configuration when the flexible diaphragm is in a collapsed configuration (col 6, ln 56-col 7, ln 22; where prior to operation, the gas tube portion 128 is not filled with material and the frame is considered to be in a collapsed configuration as the flexible diaphragm is not engaged and in a collapsed configuration), wherein the valve member is configured to linearly reciprocate within the housing to generate a pump stroke and a fill stroke of a pumping cycle (col 7, ln 10-22 where the valve member linearly reciprocates within the housing to assume either a blood intake position or a blood pump position).
Regarding claim 120, Leschinsky discloses the frame has an expanded configuration when the flexible diaphragm is in an expanded configuration (col 6, ln 56-col 7, ln 22; where during pumping operation, the gas tube portion 128 is filled with material and the frame is considered to be in an expanded configuration as the flexible diaphragm is engaged and flexes between either a blood intake position or a blood pump position).
Regarding claim 125, Leschinsky discloses the flexible diaphragm comprises a body and a rim (col 6, ln 56-col 7, ln 22; diaphragm 127 as shown in figures 11-13 where the rim couples the diaphragm to the cannula 160 and the body is the portion of the diaphragm that flexes between the blood intake state and blood pump state).
Regarding claim 127, Leschinsky discloses the rim of the flexible diaphragm is configured to maintain contact with an interior surface of the housing during at least a portion of the pump stroke (col 6, ln 56-col 7, ln 22; diaphragm 127 as shown in figures 11-13 where the rim couples the diaphragm to the cannula 160 and the body is the portion of the diaphragm that flexes between the blood intake state and blood pump state).
Regarding claim 128, Leschinsky discloses the pump comprises a gap between an interior surface of the housing and the valve member configured to prevent damage to red blood cells during the pump stroke (col 6, ln 56-col 7, ln 22; as shown in figures 11-13 where the valve is shown to include gaps to move blood in or out of the cannula 160, which Examiner interprets the gap to prevent damage to red blood cells during the pump stroke by allowing space for the blood to move).
Regarding claim 129, Leschinsky discloses the housing has an expanded configuration and a collapsed configuration (col 6, ln 56-col 7, ln 22; where prior to operation, the gas tube portion 128 is not filled with material and the frame is considered to be in a collapsed configuration as the flexible diaphragm is not engaged and in a collapsed configuration; and where during pumping operation, the gas tube portion 128 is filled with material and the frame is considered to be in an expanded configuration as the flexible diaphragm is engaged and flexes between either a blood intake position or a blood pump position).
Regarding claim 130, Leschinsky discloses the housing comprises a plurality of openings, and wherein a portion of the plurality of openings have a size or a shape different from another portion of the plurality of openings when the housing is in its expanded configuration (as shown in figures 12 and 13; col 6, ln 56-col 7, ln 22 where the openings have a different shape based on the diaphragm in a blood intake state or a blood pump position).
Regarding claim 133, Leschinsky discloses a cannula (col 6, ln 56-col 7, ln 22; cannula 160).
Regarding claim 134, Leschinsky discloses the cannula extends from a distal end of the housing (col 6, ln 56-col 7, ln 22 as shown in figures 11-13 cannula 160 has a portion that extends from the distal end of the housing).
Regarding claim 135, Leschinsky discloses the cannula extends from a proximal end of the housing (col 6, ln 56-col 7, ln 22 as shown in figures 11-13 cannula 160 has a portion that extends from the proximal end of the housing to the external non-blood pump 20).
Regarding claim 136, Leschinsky discloses an actuator coupled to the valve member (col 6, ln 56-col 7, ln 22 as shown in figure 11, the valve member is coupled to a pump 20).
Regarding claim 137, Leschinsky discloses a controller configured to adjust one or more parameters of the pumping cycle (col 6, ln 56-col 7, ln 22 as shown in figure 11, the valve member is coupled to a pump 20 which controls if the system is functioning to provide blood intake or blood pumping).
Regarding claim 138, Leschinsky discloses the one or more parameters comprise one or more of a speed of linear reciprocation of the valve member, a length of the pump stroke, and a length of the fill stroke (col 6, ln 56-col 7, ln 22 as shown in figure 11, the valve member is coupled to a pump 20 which controls if the system is functioning to provide blood intake or blood pumping which each necessarily include a length of pump or fill stroke, respectively).
Regarding claim 139, Leschinsky discloses a pump for assisting blood circulation (as shown in figures 11 and 12; col 6, ln 56-col 7, ln 22) comprising: a housing (col 6, ln 56-col 7, ln 22; cannula 160); and a valve member disposed within the housing (col 6, ln 56-col 7, ln 22; pumping chamber 160), the valve member comprising a flexible diaphragm coupled to a frame (col 6, ln 56-col 7, ln 22; diaphragm 127 and valves 114, 115), each of the flexible diaphragm and the frame having a collapsed configuration (col 6, ln 56-col 7, ln 22; where prior to operation, the gas tube portion 128 is not filled with material and the frame is considered to be in a collapsed configuration as the flexible diaphragm is not engaged and in a collapsed configuration), wherein the valve member is configured to linearly reciprocate within the housing to generate a pump stroke and a fill stroke of a pumping cycle (col 7, ln 10-22 where the valve member linearly reciprocates within the housing to assume either a blood intake position or a blood pump position).
Regarding claim 140, Leschinsky discloses each of the flexible diaphragm and the frame has an expanded configuration (col 6, ln 56-col 7, ln 22; where during pumping operation, the gas tube portion 128 is filled with material and the frame is considered to be in an expanded configuration as the flexible diaphragm is engaged and flexes between either a blood intake position or a blood pump position).
Regarding claim 143, Leschinsky discloses a cannula (col 6, ln 56-col 7, ln 22; cannula 160).
Regarding claim 144, Leschinsky discloses the cannula extends from a distal end of the housing (col 6, ln 56-col 7, ln 22 as shown in figures 11-13 cannula 160 has a portion that extends from the distal end of the housing).
Regarding claim 145, Leschinsky discloses the cannula extends from a proximal end of the housing (col 6, ln 56-col 7, ln 22 as shown in figures 11-13 cannula 160 has a portion that extends from the proximal end of the housing to the external non-blood pump 20).
Regarding claim 146, Leschinsky discloses an actuator coupled to the valve member (col 6, ln 56-col 7, ln 22 as shown in figure 11, the valve member is coupled to a pump 20).
Regarding claim 147, Leschinsky discloses a controller configured to adjust one or more parameters of the pumping cycle (col 6, ln 56-col 7, ln 22 as shown in figure 11, the valve member is coupled to a pump 20 which controls if the system is functioning to provide blood intake or blood pumping).
Regarding claim 148, Leschinsky discloses the one or more parameters comprise one or more of a speed of linear reciprocation of the valve member, a length of the pump stroke, and a length of the fill stroke (col 6, ln 56-col 7, ln 22 as shown in figure 11, the valve member is coupled to a pump 20 which controls if the system is functioning to provide blood intake or blood pumping which each necessarily include a length of pump or fill stroke, respectively).
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.
Claims 121, 122, 123, 124, 131, 132, 141, and 142 are rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky in view of Walters et al (US 2019/0117865 A1, hereinafter “Walters”).
Regarding claim 121, Leschinsky discloses the claimed invention (see rejection of claim 119 above), but does not explicitly disclose the frame is self-expandable. Walters is analogous art in regard to known constructions and configurations for blood pump systems including a catheter and membrane. Walters discloses it was known in the art to provide a frame that is self-expandable (par 0034, 0037). Applied to the invention of Leschinsky, the features of Walters would provide a frame that is self-expandable 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 Walters in the invention of Leschinsky, since such a modification would provide the predictable results of a conventional construction of an intravascular device, which are optimally effective while balancing maximized cannula size for maximum blood flow and allow for smaller profiles for insertion through narrow portions of a patient’s vasculature.
Regarding claim 122, Leschinsky discloses the claimed invention (see rejection of claim 119 above), but does not explicitly disclose the frame comprises stainless steel, nickel, titanium, or alloys thereof. Walters is analogous art in regard to known constructions and configurations for blood pump systems including a catheter and membrane. Walters discloses it was known in the art to provide a frame comprising stainless steel, nickel, titanium, or alloys thereof (par 0034, 0037). Applied to the invention of Leschinsky, the features of Walters would provide a frame comprising stainless steel, nickel, titanium, or alloys thereof 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 Walters in the invention of Leschinsky, since such a modification would provide the predictable results of a conventional construction of an intravascular device, which are optimally effective while balancing maximized cannula size for maximum blood flow and allow for smaller profiles for insertion through narrow portions of a patient’s vasculature.
Regarding claim 123, Leschinsky discloses the claimed invention (see rejection of claim 119 above), but does not explicitly disclose a flexible diaphragm comprising a polymeric material. Walters is analogous art in regard to known constructions and configurations for blood pump systems including a catheter and membrane. Walters discloses it was known in the art to provide a flexible diaphragm comprising a polymeric material (par 0034, 0037). Applied to the invention of Leschinsky, the features of Walters would provide a flexible diaphragm comprising a polymeric material 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 Walters in the invention of Leschinsky, since such a modification would provide the predictable results of a conventional construction of an intravascular device, which are optimally effective while balancing maximized cannula size for maximum blood flow and allow for smaller profiles for insertion through narrow portions of a patient’s vasculature.
Regarding claim 124, Leschinsky in view of Walters discloses the claimed invention (see rejection of claim 123 above), but (as cited) does not explicitly disclose the polymeric material comprises one or more of a silicone, polyester, and a polyurethane elastomer. Walters is analogous art in regard to known constructions and configurations for blood pump systems including a catheter and membrane. Walters discloses it was known in the art to provide the polymeric material comprising one or more of a silicone, polyester, and a polyurethane elastomer (par 0034, 0037). Applied to the invention of Leschinsky, the features of Walters would provide the polymeric material comprising one or more of a silicone, polyester, and a polyurethane elastomer 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 Walters in the invention of Leschinsky, since such a modification would provide the predictable results of a conventional construction of an intravascular device, which are optimally effective while balancing maximized cannula size for maximum blood flow and allow for smaller profiles for insertion through narrow portions of a patient’s vasculature.
Regarding claim 131, Leschinsky discloses the claimed invention (see rejection of claim 119 above), but does not explicitly disclose the housing comprises a polymer layer. Walters is analogous art in regard to known constructions and configurations for blood pump systems including a catheter and membrane. Walters discloses it was known in the art to provide the housing comprising a polymer layer (par 0034, 0037). Applied to the invention of Leschinsky, the features of Walters would provide the housing comprising a polymer layer 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 Walters in the invention of Leschinsky, since such a modification would provide the predictable results of a conventional construction of an intravascular device, which are optimally effective while balancing maximized cannula size for maximum blood flow and allow for smaller profiles for insertion through narrow portions of a patient’s vasculature.
Regarding claim 132, Leschinsky in view of Walters discloses the claimed invention (see rejection of claim 131 above), but (as cited) does not explicitly disclose the polymer layer comprises one or more of a silicone, a polyester, and a polyurethane elastomer. Walters is analogous art in regard to known constructions and configurations for blood pump systems including a catheter and membrane. Walters discloses it was known in the art to provide the polymer layer comprising one or more of a silicone, a polyester, and a polyurethane elastomer (par 0034, 0037). Applied to the invention of Leschinsky, the features of Walters would provide the polymer layer comprising one or more of a silicone, a polyester, and a polyurethane elastomer 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 Walters in the invention of Leschinsky, since such a modification would provide the predictable results of a conventional construction of an intravascular device, which are optimally effective while balancing maximized cannula size for maximum blood flow and allow for smaller profiles for insertion through narrow portions of a patient’s vasculature.
Regarding claim 141, Leschinsky discloses the claimed invention (see rejection of claim 139 above), but does not explicitly disclose the housing comprises a polymer layer. Walters is analogous art in regard to known constructions and configurations for blood pump systems including a catheter and membrane. Walters discloses it was known in the art to the housing comprising a polymer layer (par 0034, 0037). Applied to the invention of Leschinsky, the features of Walters would provide the housing comprising a polymer layer 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 Walters in the invention of Leschinsky, since such a modification would provide the predictable results of a conventional construction of an intravascular device, which are optimally effective while balancing maximized cannula size for maximum blood flow and allow for smaller profiles for insertion through narrow portions of a patient’s vasculature.
Regarding claim 142, Leschinsky in view of Walters discloses the claimed invention (see rejection of claim 141 above), but (as cited) does not explicitly disclose the polymer layer comprises one or more of a silicone, a polyester, and a polyurethane elastomer. Walters is analogous art in regard to known constructions and configurations for blood pump systems including a catheter and membrane. Walters discloses it was known in the art to provide the polymer layer comprising one or more of a silicone, a polyester, and a polyurethane elastomer (par 0034, 0037). Applied to the invention of Leschinsky, the features of Walters would provide the polymer layer comprising one or more of a silicone, a polyester, and a polyurethane elastomer 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 Walters in the invention of Leschinsky, since such a modification would provide the predictable results of a conventional construction of an intravascular device, which are optimally effective while balancing maximized cannula size for maximum blood flow and allow for smaller profiles for insertion through narrow portions of a patient’s vasculature.
Claim 126 is rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky in view of DeBakey et al (US 3,755,825, hereinafter “DeBakey”).
Regarding claim 126, Leschinsky discloses the claimed invention (see rejection of claim 125 above), but does not explicitly disclose a thickness of the rim is greater than a thickness of the body. DeBakey is analogous art in regard to constructions used for blood pumps involving a diaphragm. DeBakey discloses it was known in the art to provide a diaphragm with a rim, the rim including a thickness that is greater than the thickness of the body (col 2, ln 46-62). Applied to the invention of Walters, the features of DeBakey would provide a thickness of the rim that is greater than a thickness of the body 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 DeBakey in the invention of Walters, since such a modification would provide the predictable results of an effective anchor for the diaphragm that also provides an improved seal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 5,242,374 (Isoyama et al) discloses a known structure and configuration for an intra-aortic balloon pump that includes a diaphragm (see figure 1; abstract and column 2, ln 36-col 3, ln 37).
US 6,007,479 (Rottenberg et al) discloses known structure and configuration for a heart assist system that features a diaphragm (col 9, ln 11-col 10, ln 19; see figures 1 and 2A-B).
US 2006/0178731 A1 (Tower) discloses known structure and configuration for an apparatus for aiding the flow of blood in the circulatory system including a diaphragm and an expandable construction for fixating the device in a blood vessel (pars 0019-0025; figures 2-4).
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 5/1/2026
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