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 § 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) 1-7, 9, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0328382 Corbett et al., hereinafter “Corbett” (cited previously), in view of US 2021/0178047 Haneef et al., hereinafter “Haneef”.
Regarding claim 1, Corbett discloses a percutaneous ventricular assist device (Para 5 and 23), comprising: a pump assembly (Para 2 and 20 and Figure 1, element 101) having a distal end (Figure 1, element 101; the side closer to element 103) and proximal end (Figure 1, element 101; the side closer to element 107), the pump assembly having one or more connectors at or near the distal end (Figure 1, element 102 and Para 20 that discloses that the housing component 102 couples the pump to the cannula); and a first cannula assembly including a first cannula (Figure 1, element 104), the first cannula assembly having a distal end (Figure 1, element 104; the side closer to element 105) and a proximal end (Figure 1, element 104; the side closer to element 102), the proximal end including one or more mating connectors engageable with the one or more connectors of the pump assembly (Figure 1, element 102 and Para 20 that discloses that the housing component 102 couples the pump to the cannula, see also Para 33); wherein the first cannula assembly is configured to be attached to the pump assembly by the clinician before a medical procedure (Para 3-4, 20, and 33; it is clear that someone must attach the pump to the cannula before a cardiac procedure).
Corbett does not disclose wherein a configuration of the first cannula assembly is selectable by a clinician from a plurality of cannula assembly options based on a characteristic of a patient and/or a procedure being performed on the patient.
However, Haneef discloses a heart device (Abstract, Para 42 and 50) and teaches a configuration of the first cannula assembly is selectable by a clinician from a plurality of cannula assembly options based on a characteristic of a patient and/or a procedure being performed on the patient (Para 29, 58, and 84; “the exact lengths and diameters of cannula (a) and cannula (b) may be selected by one skilled in the medical arts based on the shape and size of the heart”); the first cannula assembly is configured to be attached to the pump assembly by the clinician before a medical procedure (Para 29, 58, and 84; the cannula is selected based on the shape and size of a patient’s heart, therefore is it obvious to one of ordinary skill in the art that the cannula is attaches to the pump after knowing the patients parameters before the procedure starts).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed multiple cannula options as taught by Haneef, in the invention of Corbett, in order to find the appropriate cannula that fits the user’s characteristics/size (Haneef; Para 29, 58, and 84).
Regarding claim 2, Corbett discloses the first cannula assembly includes a first inflow cage attached to the first cannula assembly (Figure 1, element 105 attached to element 104).
Regarding claim 3, Corbett discloses the first cannula assembly is removably attachable to the pump assembly (Para 20 and 33; Corbett defines that the cannula and pump are coupled to one another using the housing and in Para 33 defines coupling as a removable attachment).
Regarding claim 4, Corbett discloses a pigtail (Figure 1, element 106) operably connected to a distal portion of the first cannula assembly (Figure 1, element 106 is connected to the distal portion of element 104, see also Para 20).
Regarding claim 5, Corbett discloses the pigtail is fixedly attached to the distal end of the first cannula assembly such that the first cannula assembly and pigtail are attachable to the pump assembly as a single coupled assembly (See Para 24-25 and Figure 1, see also Para 20; the pigtail attaches to the cannula and they’re both as one unit coupled to the pump 101).
Regarding claim 6, Corbett discloses the pigtail is fixedly attached to a first inflow cage of the first cannula assembly (Para 25, 33, and Figure 1, elements 105 and 106).
Regarding claim 7, Corbett discloses the pigtail is removably attachable to a first inflow cage of the first cannula assembly (Para 25, 33, and Figure 1, elements 105 and 106).
Regarding claim 9, Corbett discloses the percutaneous ventricular assist device (Para 5 and 23) is a catheter-based heart pump (Para 2 and 20).
Regarding claim 18, Corbett discloses a system for ventricular assistance (Para 5 and 23), comprising: a percutaneous ventricular assist device according to claim 1 (Para 5 and 23); and a controller configured to control the percutaneous ventricular assist device (Para 20).
Claim(s) 8, 10-11, 14-15, 19, 56, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0328382 Corbett et al., hereinafter “Corbett”, in view of US 2021/0178047 Haneef et al., hereinafter “Haneef”, further in view of US 2015/0133719 Callaway et al., hereinafter “Callaway” (cited previously).
Regarding claim 8, Corbett discloses a cannula assembly with an inflow cage (Figure 1, element 105 attached to element 104); and wherein the first cannula assembly or the second cannula assembly is configured to be attached to the pump assembly by the clinician prior to the medical procedure (Para 3-4, 20, and 33; it is clear that someone must attach the pump to the cannula before a cardiac procedure).
Corbett does not disclose a second cannula assembly including a second cannula; wherein the second cannula assembly has a distal end and a proximal end, the proximal end of the second cannula assembly including one or more mating connectors is engageable with the connectors of the pump assembly such that the second cannula assembly is attachable to pump assembly; wherein the second cannula assembly is different than the first cannula assembly.
However, Callaway discloses a pump assembly with an inflow cannula (Abstract) and teaches a second cannula assembly including a second cannula (Para 11, 13, and 39-40, see also Figure 1A, element 120); wherein the second cannula assembly has a distal end (Figure 1A, element 120 right side) and a proximal end (Figure 1A, element 120 left side), the proximal end of the second cannula assembly including one or more mating connectors is engageable with the connectors of the pump assembly such that the second cannula assembly is attachable to pump assembly (Figure 1A, elements 100 and 120; see also Para 39); wherein the second cannula assembly is different than the first cannula assembly (Para 11, 13, and 39-40; every cannula has a different size and is intended for different purposes).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a second cannula assembly as taught by Callaway, in the invention of Corbett, in order to allow for cannula options that can be used for a particular purpose that a patient requires (Callaway; Para 40).
Regarding claim 10, Corbett discloses the pump assembly includes a motor (Para 8) operably connected to an impeller (Para 8), the impeller configured to cause blood to flow through the first cannula assembly, the second cannula assembly, or a combination thereof, wherein the first cannula assembly includes a first inlet cage (Para 8, causes blood slow through the cannula, and to the inlet cage 105 connected to cannula 104).
Regarding claim 11, Corbett discloses all the limitations of claim 1.
Corbett does not disclose each mating connector comprises a threaded portion.
However, Callaway teaches each mating connector comprises a threaded portion (Para 40).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a threaded portion as taught by Callaway, in the invention of Corbett, in order to allow the clinician to adapt the blood pump for a particular purpose (Callaway; Para 40).
Regarding claim 14, Corbett discloses all the limitations of claim 1.
Corbett does not disclose one mating connector comprises a detent, and one connector comprises at least one wall defining an opening extending at least partially though the wall, the opening configured to receive a portion of the detent.
However, Callaway teaches one mating connector comprises a detent, and one connector comprises at least one wall defining an opening extending at least partially though the wall, the opening configured to receive a portion of the detent (Para 40 discloses a “snap-fit connection” which is known in the art to be one element that fits in an opening of another element and “snaps” in place; therefore, examiner believes these limitations are taught).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a detent and an opening as taught by Callaway, in the invention of Corbett, in order to allow the clinician to adapt the blood pump for a particular purpose (Callaway; Para 40).
Regarding claim 15, Corbett discloses all the limitations of claim 1.
Corbett does not disclose each mating connector comprises a detent, and each connector comprises at least one wall defining an opening extending at least partially though the wall, the opening configured to receive a portion of the detent.
However, Callaway teaches each mating connector comprises a detent, and each connector comprises at least one wall defining an opening extending at least partially though the wall, the opening configured to receive a portion of the detent (Para 40 discloses a “snap-fit connection” which is known in the art to be one element that fits in an opening of another element and “snaps” in place; therefore, examiner believes these limitations are taught).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a detent and an opening as taught by Callaway, in the invention of Corbett, in order to allow the clinician to adapt the blood pump for a particular purpose (Callaway; Para 40).
Regarding claim 19, Corbett discloses a kit (Figure 1, element 100) comprising: a pump assembly (Para 2 and 20 and Figure 1, element 101) having one or more connectors (Figure 1, element 102 and Para 20 that discloses that the housing component 102 couples the pump to the cannula) at or near a distal portion (Figure 1, element 101; the side closer to element 103); a first cannula assembly (Figure 1, element 104) having one or more mating connectors (Figure 1, element 102 and Para 20 that discloses that the housing component 102 couples the pump to the cannula, see also Para 33) at or near a proximal portion of the first cannula assembly (Figure 1, element 104; the side closer to element 102); wherein the one or more mating connectors of first cannula assembly engage with the one or more connector of the pump assembly such that the first cannula assembly is coupled to the pump assembly (Figure 1, element 102 and Para 20 that discloses that the housing component 102 couples the pump to the cannula, see also Para 33).
Corbett does not disclose a second cannula assembly having one or more mating connectors at or near a proximal portion of the second cannula assembly, the second cannula assembly being different than the first cannula assembly; , and wherein the one or more mating connectors of second cannula assembly engage with the one or more connector of the pump assembly such that the first cannula assembly is coupled to the pump assembly.
However, Callaway teaches a second cannula assembly (Para 11, 13, and 39-40, see also Figure 1A, element 120) having one or more mating connectors (Figure 1A, elements 100 and 120; see also Para 39) at or near a proximal portion of the second cannula assembly (Figure 1A, element 120 left side), the second cannula assembly being different than the first cannula assembly (Para 11, 13, and 39-40; every cannula has a different size and is intended for different purposes); , and wherein the one or more mating connectors of second cannula assembly engage with the one or more connector of the pump assembly such that the first cannula assembly is coupled to the pump assembly (Para 39 and Figure 1A-B).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a second cannula assembly as taught by Callaway, in the invention of Corbett, in order to allow for cannula options that can be used for a particular purpose that a patient requires (Callaway; Para 40).
Corbett does not disclose a plurality of assembly options.
However, Haneef teaches a plurality of assembly options (Para 29, 58, and 84; “the exact lengths and diameters of cannula (a) and cannula (b) may be selected by one skilled in the medical arts based on the shape and size of the heart”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed multiple cannula options as taught by Haneef, in the invention of Corbett, in order to find the appropriate cannula that fits the user’s characteristics/size (Haneef; Para 29, 58, and 84).
Regarding claim 56, Corbett discloses a percutaneous ventricular assist device (Para 5 and 23), comprising: a pump assembly (Para 2 and 20 and Figure 1, element 101) having a distal end (Figure 1, element 101; the side closer to element 103) and proximal end (Figure 1, element 101; the side closer to element 107); a first cannula assembly having a first cannula (Figure 1, element 104) and a sensor (Para 20), the first cannula assembly having a distal end (Figure 1, element 104; the side closer to element 105) and a proximal end (Figure 1, element 104; the side closer to element 102) attached to the pump assembly (Figure 1, element 104 is attached to 101 via 102), the distal end having one or more connectors (Figure 1, element 102 and Para 20 that discloses that the housing component 102 couples the pump to the cannula, see also Para 33); and a first inflow cage (Figure 1, element 105 attached to element 104).
Corbett does not disclose a second cannula assembly having a second cannula; wherein the second cannula includes one or more mating connectors engageable with the one or more connectors of the first cannula assembly such that the second cannula assembly is attachable to the first cannula assembly by a clinician before a medical procedure.
However, Callaway teaches a second cannula assembly having a second cannula (Para 11, 13, and 39-40, see also Figure 1A, element 120); wherein the second cannula includes one or more mating connectors engageable with the one or more connectors of the first cannula assembly such that the second cannula assembly is attachable to the first cannula assembly by a clinician before a medical procedure (Para 11; the cannula can have two lengths connectable via a coupling feature; first portion and second portion).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a second cannula assembly as taught by Callaway, in the invention of Corbett, in order to allow for cannula options that can be used for a particular purpose that a patient requires (Callaway; Para 40).
Corbett does not disclose wherein a configuration of the first cannula assembly is selectable by a clinician from a plurality of cannula assembly options based on a characteristic of a patient and/or a procedure being performed on the patient.
However, Haneef teaches a configuration of the first cannula assembly is selectable by a clinician from a plurality of cannula assembly options based on a characteristic of a patient and/or a procedure being performed on the patient (Para 29, 58, and 84; “the exact lengths and diameters of cannula (a) and cannula (b) may be selected by one skilled in the medical arts based on the shape and size of the heart”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed multiple cannula options as taught by Haneef, in the invention of Corbett, in order to find the appropriate cannula that fits the user’s characteristics/size (Haneef; Para 29, 58, and 84).
Regarding claim 73, Corbett discloses a percutaneous ventricular assist device (Para 5 and 23), comprising: a pump assembly (Para 2 and 20 and Figure 1, element 101) having a distal end (Figure 1, element 101; the side closer to element 103) and proximal end (Figure 1, element 101; the side closer to element 107), the pump assembly having one or more connectors at or near the distal end (Figure 1, element 102 and Para 20 that discloses that the housing component 102 couples the pump to the cannula, see also Para 33); and a first cannula assembly including a first cannula (Figure 1, element 104), the first cannula assembly having a distal end (Figure 1, element 104; the side closer to element 105) and a proximal end (Figure 1, element 104; the side closer to element 102), the proximal end including one or more mating connectors (Figure 1, element 102 and Para 20 that discloses that the housing component 102 couples the pump to the cannula, see also Para 33); wherein the first cannula assembly is configured to be attached to the pump assembly by the clinician before a medical procedure (Para 3-4, 20, and 33; it is clear that someone must attach the pump to the cannula before a cardiac procedure).
Corbett does not disclose the one or more connectors comprising at least one wall defining an opening extending at least partially though the wall, the opening configured to receive a portion of a detent.
However, Callaway teaches the one or more connectors comprising at least one wall defining an opening extending at least partially though the wall, the opening configured to receive a portion of a detent (Para 40 and 55).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a detent as taught by Callaway, in the invention of Corbett, in order to allow for a modular attachment that can permit a clinician to adapt a blood pump for a particular use (Callaway; Para 40).
Corbett does not disclose wherein a configuration of the first cannula assembly is selectable by a clinician from a plurality of cannula assembly options based on a characteristic of a patient and/or a procedure being performed on the patient.
However, Haneef teaches a configuration of the first cannula assembly is selectable by a clinician from a plurality of cannula assembly options based on a characteristic of a patient and/or a procedure being performed on the patient (Para 29, 58, and 84; “the exact lengths and diameters of cannula (a) and cannula (b) may be selected by one skilled in the medical arts based on the shape and size of the heart”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed multiple cannula options as taught by Haneef, in the invention of Corbett, in order to find the appropriate cannula that fits the user’s characteristics/size (Haneef; Para 29, 58, and 84).
Claim(s) 12-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0328382 Corbett et al., hereinafter “Corbett”, in view of US 2021/0178047 Haneef et al., hereinafter “Haneef”, further in view of US 2015/0133719 Callaway et al., hereinafter “Callaway”, further in view of US 2009/0264697 Tovar Lopez, hereinafter “Lopez” (cited previously).
Regarding claim 12, Corbett discloses all the limitations of claim 11.
Corbett does not disclose each mating connector, each connector, or both have a coating comprising an additive.
However, Lopez discloses a VAD pump device (Abstract and Para 1) and teaches each mating connector, each connector, or both have a coating comprising an additive (Para 9 and 42; Figure 1, element 128 and 130 are the connectors that connect pump 100 to the cannula).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a coating comprising an additive as taught by Lopez, in the invention of Corbett, in order to allow for the flexibility of the device (Lopez; Para 9 and 42).
Regarding claim 13, Corbett discloses all the limitations of claim 12.
Corbett does not disclose the additive comprises silicone.
However, Lopez teaches the additive comprises silicone (Para 9 and 42; Figure 1, element 128 and 130 are the connectors that connect pump 100 to the cannula).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a coating comprising silicone as taught by Lopez, in the invention of Corbett, in order to allow for the flexibility of the device (Lopez; Para 9 and 42).
Regarding claim 16, Corbett discloses all the limitations of claim 15.
Corbett does not disclose each mating connector further comprises a gasket, the detent being positioned between the gasket and the connector.
However, Callaway teaches each mating connector further comprises a gasket, the detent being positioned between the gasket and the connector (Figure 6A, a gasket 617 is positioned between coupling members 618 and 622, see also Para 68).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a gasket as taught by Callaway, in the invention of Corbett, in order to mitigate the risk of blood and/or other fluids leaking past the threaded connection (Callaway; Para 68).
Corbett does not disclose each mating connector further comprises a silicone.
However, Lopez teaches each mating connector further comprises a silicone (Para 9 and 42; Figure 1, element 128 and 130 are the connectors that connect pump 100 to the cannula).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a coating comprising silicone as taught by Lopez, in the invention of Corbett, in order to allow for the flexibility of the device (Lopez; Para 9 and 42).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0328382 Corbett et al., hereinafter “Corbett”, in view of US 2021/0178047 Haneef et al., hereinafter “Haneef”, further in view of US 2012/0059398 Pate et al., hereinafter “Pate” (cited previously).
Regarding claim 17, Corbett discloses all the limitations of claim 1.
Corbett does not disclose each mating connector, each connector, or both comprises a magnetic element.
However, Pate discloses a coupling assembly for a cannula (Abstract) and teaches each mating connector, each connector, or both comprises a magnetic element (Para 31).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a magnetic connector as taught by Pate, in the invention of Corbett, in order to allow the tube to be easily removed, repositioned, and reattached without having to manipulate any other securing mechanism such as sutures, fasteners, or clamping screws as is common with the prior art (Pate; Para 31).
Response to Arguments
Applicant’s arguments have been fully considered and examiner agrees. Refer above for the new ground of rejection.
As agreed on in the Interview, Examiner agrees with the argument that fails to combine references Corbett and Elibol. For this reason, examiner applied a new reference “Haneef” that more closely resembles the invention of Corbett and allows a cannula to be inserted through an access point away from the heart through the blood vessels (See Fig. 3C of Haneef). Examiner believes this reference provides proper obviousness for combination with Corbett.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796