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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 has been entered. Claims 1-12 and 14-21 are pending. Claims 5-12 and 15-20 were withdrawn during an earlier restriction requirement. Claims 1-4, 14 and 21 are currently under examination.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0228211 to Leasure (Leasure) (previously cited) in view of US 2010/0087773 to Ferrari (Ferrari).
In reference to at least claim 1
Leasure discloses a cyclical pressure coronary assist pump which discloses a heart support device for circulatory assistance (e.g. “left ventricle assist device”, para. [0006]), the device comprising: a chamber body comprising an outer wall and defining an internal volume (Vx) configured to receive a volume of fluid (e.g. pumping chamber 118 including an internal volume for receiving fluid, Figs. 1-3), wherein the chamber body extends from a proximal end to a distal end (e.g. pumping chamber 118 extends from a proximal end to a distal end, Figs. 1-3) and is configured to be at least partially placed in a heart chamber (e.g. pumping chamber 118 is placed within a heart chamber, Fig. 1); and a catheter extending from the proximal end of the chamber body (e.g. elongate member 122, Figs. 1-3), wherein the chamber body comprises an outlet opening at its proximal end (e.g. openings 120 or 320 or 420 or 520 serves as an intake and outtake, para. [0022]), the outlet opening being in fluid communication with an exterior volume in which the chamber body is disposed (e.g. opening 120 in fluid communication with exterior volume, Fig. 1), wherein the chamber body has an inner side exposed to the internal volume and an outer side exposed to the exterior volume (e.g. pumping chamber 118 has an inner side exposed to the internal volume and an outer side exposed to the exterior volume, Fig. 1); wherein the outer wall of the chamber body is configured to alternately collapse and expand during repeated pumping cycles between a first configuration in which the internal volume Vx=V1 and a second configuration in which the internal volume Vxs=V2, wherein V1 is larger than V2 (e.g. pumping chamber 118 alternately collapse and expand during pumping cycles, Figs. 2-3), and thereby pump the fluid through the outlet opening during the pumping cycles (e.g. opening 120 serves as an intake and outtake, para. [0022]). Leasure discloses that the pump moves to the contracted state and blood rushes in the direction of the aortic valve (e.g. “When the pump moves to the contracted state, blood rushes out in the direction of the aortic valve”, para. [0027]).
However Leasure does not explicitly teach an elongated portion having an outlet opening at the proximal end of the chamber body, the elongated portion configured to extend through a heart valve and into a vessel adjacent the heart chamber when the chamber body is placed in the heart chamber.
Ferrari discloses a heart support device for circulatory assistance (e.g. “ a device is proposed for circulating a body fluid in a body of a living organism, especially to support the heart and/or circulation of the living organism”, para. [0009]), the device comprising: a chamber body comprising an outer wall and defining an internal volume (Vx) configured to receive a volume of fluid (e.g. chamber 7 and pump cannula 2), wherein the chamber body extends from a proximal end to a distal end (e.g. chamber 7 and pump cannula 2 has a proximal and distal end) and is configured to be at least partially placed in a heart chamber (e.g. chamber 7 can be placed in the atria or ventricles, Figs. 2, 4, “In this case the inlet portion of the device 1 is in the right atrium 19, the right ventricle 14 or the vena cava,”, para. [0026], [0034], “The pump process can be used to support the right or left chamber of the heart or for both chambers of the heart (2-pump catheter) according to the version.”, para. [0040]); wherein the chamber body comprises an elongated portion having an outlet opening at the proximal end of the chamber body (e.g. pump cannula 2 is an elongated portion that includes outlet apertures 15, Fig. 4), the elongated portion configured to extend through a heart valve and into a vessel adjacent the heart chamber when the chamber body is placed in the heart chamber (e.g. pump cannula 2 extends through a heart valve into a vessel adjacent the heart chamber, Fig. 4 “thus shows an embodiment of a version of the device for supporting the right chamber of the heart 14. As a result, a portion of the device can also be fitted in the pulmonary artery 18, to support the right ventricle 14.”, para. [0034]-[0035]) and the chamber body including an inlet opening in the outer wall of the chamber body to provide fluid communication between the internal volume of the chamber body and the exterior volume (e.g. 16, Figs. 4, “several inlet valves 16 which are arranged in the region of the outer wall of the outer chamber 7 of the pump device 5”, para. [0033]-[0034]). Ferrari discloses that the pump device guarantees a large pump capacity with minimal external surface and a small diameter on the heart (e.g. para. [0010], [0039]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Leasure to include at the outlet opening forming the chamber body to include a pump cannula “elongated portion” that extends through a heart valve and into a vessel adjacent the heart chamber when the chamber body is placed in the heart chamber and inlet openings on the outer wall of the chamber body, as taught by Ferrari, in order to provide a large pump capacity that provides directed transport of the body fluid between the inlet and the outlet with minimal external surface and a small diameter on the heart (‘773, para. [0010]).
In reference to at least claim 2
Leasure modified by Ferrari renders obvious a device according to claim 1. Leasure further discloses wherein the chamber body further comprises a deformable support structure configured to support the chamber body in an open configuration (e.g. frame 126 or 228 or 326 or 426 or 526)
In reference to at least claim 3
Leasure modified by Ferrari renders obvious a device according to claim 1. Leasure further wherein the chamber body is biased into the second, collapsed configuration (e.g. biased into collapsed position using actuating struts 128 or 440 or 528, Fig. 3, 5B, 7-8, “control mechanism to control the rate of operation of the pump”, para. [0035]), and wherein the device further comprises an actuation system configured to expand the chamber body against its bias (e.g. actuating struts 128 or 440 or 528 can expand the chamber, Figs. 2, 4,7-8; “control mechanism to control the rate of operation of the pump”, para. [0035])
In reference to at least claim 4
Leasure modified by Ferrari renders obvious a device according to claim 1. Leasure further wherein the chamber body is biased into the first, expanded configuration (e.g. expanded state, Figs. 2, 4,7-8; “control mechanism to control the rate of operation of the pump”, para. [0035]), and wherein the device further comprises an actuation system configured to collapse the chamber body against its bias (e.g. using actuating struts 128 or 440 or 528 to provide a contracted state Figs. 3,5B; “control mechanism to control the rate of operation of the pump”, para. [0035]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0228211 to Leasure (Leasure) in view of US 2010/0087773 to Ferrari (Ferrari) further in view of US Patent No. 5,820,542 to Dobak, III et al. (Dobak) (previously cited) and US Patent No. 5,928,132 to Leschinsky (Leschinsky).
In reference to at least claim 14
Leasure modified by Ferrari renders obvious a device according to claim 1. Ferrari discloses providing directional flow but does not explicitly teach wherein the inlet opening is closed by a one way valve. The use of one-way valves including at an inlet allowing blood to flow in but not out through the inlet providing desired direction flow as well known in the art as evidence by Dobak (e.g. “This embodiment also exhibits a one-way inlet valve 40 in the port 22, and a one-way outlet valve 42 in the first lumen 34, to control the direction of flow of the vascular fluid. The arrangement of the one-way valves 40, 42 would allow the CAD 10 to draw in blood, for instance, at the aortic arch, and direct the flow of blood to a particular artery, to perfuse a selected organ. Other arrangements of one-way valves could be used to control the direction of flow as desired for any particular application.”, Col. 9, ll. 27-35) or Leschinsky (e.g. “The smaller diameter portion has an intake valve at its distal end which acts as a one-way valve allowing blood to flow into the lumen of the pumping chamber but not out of it”, abstract, Col. 3, ll. 13-16). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Leasure to include a one-way inlet valve allowing blood to flow in but not out as such technique was well-known and would have yielded the predictable result of controlling the direction of flow as desired ensuring one-way flow throughout for any particular application (‘542, Col. 9, ll. 27-35).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0228211 to Leasure (Leasure) in view of US 2010/0087773 to Ferrari (Ferrari) as applied to claim 1 further in view of US 2006/0008497 to Gabbay (Gabbay) (previously cited).
In reference to at least claim 21
Leasure modified by Ferrari renders obvious a device according to claim 1. Leasure further discloses the pump wall being made of any biocompatible flexible material (e.g. “Pump 100 may have a round or a slightly oval cross-section, as desired for a particular application. Wall 116 may be made of any biocompatible flexible material. Wall 116 may be made from a non-elastic material, or from an elastic material. If wall 116 is made from an elastic material, the wall may be sized to be stretched when the pump is in an expanded position.”, para. [0022]).
However, Leasure modified by Ferrari does not explicitly teach the outer wall including a mesh.
It was well known in the art before the effective filing date of the claimed invention to use cardiac materials such as fabrics, felts, mesh and patches within implantable apparatus for improved biocompatibility as evidence by Gabbay (e.g. “Various examples usable in accordance with the invention are known in the art. Examples include catheters, suture material, tubing, fiber membranes, bone growth stimulators, bone screws, grafts, implantable pumps… and facial implants, cardiac materials, such as fabric, felts, mesh,..”, para. [0020]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Leasure modified by Ferrari to include a mesh material on an outer wall of the chamber body as such material was known in the art and would have provided improved biocompatibility. Additionally, it would have been obvious to one having ordinary skill in the art at the time of the invention to make the outer wall of the chamber body to include a mesh, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
Response to Arguments
Applicant’s arguments, see pgs. 6-8, filed 1/5/2026, with respect to the rejection(s) of claim(s) 1-4 and 14 under USC 103 using Leasure, Dobak and Horgan have been fully considered and are persuasive in view of the claim amendments which now recite “an elongated portion”. Therefore, the USC 103 rejection against claims 1-4 and 14 using Leasure, Dobak and Horgan within the office action mailed 11/3/2025 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2010/0087773 to Ferrari, see rejections above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2017/0056574 to Pfeifer et al. which discloses directional conveyance of body fluid using a chamber that has an elongated portion and inlets and outlets that include a valve foil.
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/JENNIFER L GHAND/Examiner, Art Unit 3796