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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marseille et al (U.S. Patent Application Publication Number: US 2007/0197854 A1, hereinafter “Marseille”).
Regarding claim 1, Marseille teaches a mechanical circulatory support system (e.g. 10 Figs.2,3A-D, [0015]) comprising:
an implantable blood pump (e.g. 12 Figs.1,2,3A-D, [0015]); and
a system controller (e.g. 18 Figs.1,2,3A-D, [0015]) configured to control operation of the implantable blood pump,
wherein the system controller comprises a system controller rechargeable energy storage device (e.g. 30Figs.2,3A-D Fig.1, [0015]),
a system controller input connector (e.g. 38,40 Figs.2,3A-D, [0015]),
a system controller output connector, wherein the system controller output connector is configured for operatively coupling the system controller to the implantable blood pump (e.g. 41 Figs.2,3A-D, [0015]), and
a system controller display, wherein the system controller is configured to display a system controller charge level indicator on the system controller display indicative of a charge level of the system controller rechargeable energy storage device (e.g. 48 Figs.1,2,3A-D, [0016]);
wherein the system controller input connector (e.g. 38,40 Figs.2,3A-D, [0015]) is configured for operatively coupling the system controller with a power source configured to supply electrical power to the system controller for use in recharging the system controller rechargeable energy storage device and powering operation of the implantable blood pump (e.g. [0017]: At the same time that adaptor 50 is supplying electrical power to controller 18 and pump 12, it may also be recharging battery 30).
Regarding claim 2, Marseille teaches that at the same time that the adaptor 50 is supplying electrical power to controller 18 and pump 12, it may also be recharging battery 30 (e.g. [0017]) and therefore they teach that the system controller rechargeable energy storage device (e.g. 30Figs.2,3A-D Fig.1, [0015]), and the system controller input connector (e.g. 38,40 Figs.2,3A-D, [0015]) are electrically connected in parallel to the system controller output connector (e.g. 41 Figs.2,3A-D, [0015]) to accommodate simultaneous output of electrical power to the implantable blood pump (e.g. 12 Figs.1,2,3A-D, [0015]) via the system controller output connector (e.g. 41 Figs.2,3A-D, [0015]) and charging of the system controller rechargeable energy storage device via electrical power received via the system controller input connector.
Regarding claim 3, Marseille teaches that the system comprises an implantable blood pump and the controller lies externally (e.g. [0015]) and is connected to the blood pump via the electrical line (e.g. 20 Fig1-3) and therefore teach a percutaneous cable configured for operatively coupling the system controller to the implantable blood pump via the system controller output connector.
Regarding claim 5, Marseille teaches the system controller is configured to display a major failure notification on the system controller display that indicates that a major failure of the system is occurring to alert a user to seek immediate assistance and/or support (e.g. [0018]: display 78 displays alarm status).
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.
Claims 3, 4 and 6-20 are rejected under 35 U.S.C. 103 as being unpatentable over Marseille et al (U.S. Patent Application Publication Number: US 2007/0197854 A1, hereinafter “Marseille”) in view of Bolyard et al (U.S. Patent Application Publication Number: US 2012/0130153 A1, hereinafter “Bolyard”).
Regarding claim 3, Marseille teaches that the system comprises an implantable blood pump and the controller lies externally (e.g. [0015]) and is connected to the blood pump via the electrical line (e.g. 20 Fig1-3) but does not specifically teach that the electrical line is a percutaneous cable.
In a similar field of endeavor, Bolyard teaches an implantable blood pump, connected to an external controller percutaneously (e.g. Fig.1, [0025]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the electrical line in the teachings of Marseille to be percutaneously connect the implantable blood pump with the external controller as taught by Bolyard in order to provide the predictable results of providing a safe and effective system.
Regarding claim 4, Marseille teaches the system displays battery life (e.g. [0016]: The display 48 indicates estimated remaining battery life in hours and minutes) but does not specifically teach that the controller charge level indicator has a battery shape and segments that are selectively illuminated to indicate the charge level of the system controller rechargeable energy storage device.
In a similar field of endeavor, Bolyard teaches an implantable blood pump, connected to an external controller that comprises a display screen 52, input buttons 54, as well as mute button 70 and status indicators 72 and 74 (e.g. Fig. 2B, [0025], [0032]). They teach that the display 52 may be configured to display the charge status of removable battery 24 and the internal battery of control and power source module 12, as well as present alarms to a user including instructions for taking action in response to the alarm (e.g. [0028]). They further teach that the controller charge level indicator has a battery shape and segments that are selectively illuminated to indicate the charge level of the system controller rechargeable energy storage device (e.g. 200. 202 Figs 7A-C ,[0081],[0083]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the display of Marseille to display the controller charge level indicator as a battery shape with segments that are selectively illuminated to indicate the charge level of the system controller rechargeable energy storage device in order to provide the predictable results of providing a more user friendly display status.
Regarding claims 6 and 7, Marseille teaches the claimed invention as discussed above, except for the system controller comprising a speaker and being configured to output a major failure audio output via the speaker that indicates that the major failure of the system is occurring and wherein the system controller comprises an input button; and the system controller is configured to silence the major failure audio output.
In a similar field of endeavor, Bolyard teaches an implantable blood pump, connected to an external controller that comprises a speaker (e.g. Fig. 3, [0050]) and configured to output a major failure audio output via the speaker that indicates that the major failure of the system is occurring (e.g. [0089]) and wherein the system controller comprises an input button and the system controller is configured to silence the major failure audio output (e.g. 70 Fig. 2E, [0038]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the controller of Marseille to have a speaker and be configured to output a major failure audio output via the speaker that indicates that the major failure of the system is occurring and also comprise an input button; and the system controller is configured to silence the major failure audio output in order to provide the predictable results of providing a more user friendly mutable alarm status.
Regarding claim 8, Marseille teaches the claimed invention as discussed above, except for further comprising a first and second rechargeable modular energy storage device comprising a first device output connector configured to be coupled with the system controller input connector, wherein the first rechargeable modular energy storage device is configured to supply energy to the system controller for use in recharging the system controller rechargeable energy storage device and powering operation of the implantable blood pump.
In a similar field of endeavor, Bolyard teaches an implantable blood pump, connected to an external controller that comprises an internal battery 80, a removeable battery 24 that charges the internal battery and a third battery ( e.g. [0060]-[0064]: An external power source connected to control and power source module 12 via port 62 may function not only to charge removable battery 24 and internal battery 80 that may also be removeable , but also as a third source of power for the device). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Marseille to further include multiple removable batteries as taught by Bolyard in order to provide the predictable results of ensuring that the blood pump has enough power at all times.
Regarding claims 9 and 10, Marseille in view of Bolyard teaches the claimed invention as discussed above but do not teach the first rechargeable modular energy storage device comprises a first charge level indicator via which a charge level status of the first rechargeable modular energy storage device is displayed and the system controller is configured to display a first battery depletion notification on the system controller display when a charge state of the first rechargeable modular energy storage device has decreased to a first threshold of depletion.
Bolyard further teaches displaying a first charge level indicator via which a charge level status of the first rechargeable modular energy storage device is displayed and the system controller is configured to display a first battery depletion notification on the system controller display when a charge state of the first rechargeable modular energy storage device has decreased to a first threshold of depletion( e.g. [0038], Fig. 6 [0078],[0079]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Marseille in view of Bolyard with the first charge level indicator via which a charge level status of the first rechargeable modular energy storage device is displayed and displaying a first battery depletion notification on the system controller display when a charge state of the first rechargeable modular energy storage device has decreased to a first threshold of depletion as taught by Bolyard in order to provide the predictable results of improving safety by providing the patient with a user friendly notification to alert them of the battery status.
Regarding claims 11 and 12, Marseille in view of Bolyard teaches the claimed invention as discussed above but do not teach the system controller comprises a speaker; the system controller is configured to output a first battery depletion audio output via the speaker that indicates that the charge state of the first rechargeable modular energy storage device has decreased to the first threshold of depletion and the system controller comprises an input button; and the system controller is configured to silence the first battery depletion audio output.
Bolyard further teaches the external controller comprises a speaker (e.g. Fig. 3, [0050]) configured to output a first battery depletion audio output via the speaker that indicates that the charge state of the first rechargeable modular energy storage device has decreased to the first threshold of depletion (e.g.[0089], [0091]: speakers provide alarms that have different volumes thus indicating severity of the battery state) and the system controller comprises an input button; and the system controller is configured to silence the first battery depletion audio output (e.g. 70 Fig. 2E, [0038]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the controller of Marseille to have a mutable speaker that indicates battery status based on thresholds with varying volume as taught by Bolyard in order to provide the predictable results of providing a more user friendly mutable alarm status.
Regarding claims 13 and 14, Marseille in view of Bolyard teaches the claimed invention as discussed above but do not teach the system controller is configured to display a second battery depletion notification on the system controller display when a charge state of the first rechargeable modular energy storage device has decreased to a second threshold of depletion; and the second threshold of depletion is greater than the first threshold of depletion and the first battery depletion notification comprises a yellow flashing symbol; and the second battery depletion notification comprises a red flashing symbol.
Bolyard further teaches the external controller is configured to display a second battery depletion notification on the system controller display when a charge state of the first rechargeable modular energy storage device has decreased to a second threshold of depletion; and the second threshold of depletion is greater than the first threshold of depletion and the first battery depletion notification comprises a yellow flashing symbol; and the second battery depletion notification comprises a red flashing symbol ( e.g. Figs. 7A-C, 8, 9, [0076]-[0079], Fig. 6 shows states 170-194 of the power sources connected to control and power source module 12, e.g. removable battery 24, internal battery 80, and external power source connected via port 62 and battery depletion notifications indicated as green, yellow, red based on battery charge threshold levels). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Marseille in view of Bolyard to display a second battery depletion notification on the system controller display when a charge state of the first rechargeable modular energy storage device has decreased to a second threshold of depletion; and the second threshold of depletion is greater than the first threshold of depletion and the first battery depletion notification comprises a yellow flashing symbol; and the second battery depletion notification comprises a red flashing symbol as taught by Bolyard in order to provide the predictable results of providing a user friendly device that warns the patient of the battery state as the battery depletion progresses.
Regarding claims 15 and 16, Marseille in view of Bolyard teaches the claimed invention as discussed above but do not teach a second rechargeable modular energy storage device comprising a second device output connector device configured to be coupled with a first device input connector of the first rechargeable modular energy storage device, wherein the second rechargeable modular energy storage device is configured to supply energy to the first rechargeable modular energy storage device for use in recharging the first rechargeable modular energy storage device, recharging the system controller rechargeable energy storage device, and/or powering operation of the implantable blood pump and wherein the first rechargeable modular energy storage device and the first device input connector are electrically connected in parallel to the first device output connector to accommodate simultaneous output of electrical power to the system controller via the first device output connector and charging of the first rechargeable modular energy storage device via electrical power received via the first device input connector.
Bolyard teaches an external controller that comprises an internal battery 80, a removeable battery 24 that charges the internal battery and a third battery (e.g. [0060]-[0064]: An external power source connected to control and power source module 12 via port 62 may function not only to charge removable battery 24 and internal battery 80 that may also be removeable , but also as a third source of power for the device that recharges the internal battery and supplies power to the pump and is therefore connected in parallel). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Marseille to further include multiple batteries as taught by Bolyard in order to provide the predictable results of ensuring that the blood pump has enough power at all times.
Regarding claims 17-20, Marseille in view of Bolyard teaches the claimed invention as discussed above but do not teach the second rechargeable modular energy storage device comprises a second charge level indicator via which a charge level status of the second rechargeable modular energy storage device is displayed and wherein the system controller is configured to display a first battery depletion notification on the system controller display when a charge state of either of the first rechargeable modular energy storage device and the second rechargeable modular energy storage device has decreased to a first threshold of depletion and the system controller is configured to display a second battery depletion notification on the system controller display when a charge state of either of the first rechargeable modular energy storage device and the second rechargeable modular energy storage device has decreased to a second threshold of depletion; and the second threshold of depletion is greater than the first threshold of depletion and the first battery depletion notification comprises a yellow flashing symbol; and the second battery depletion notification comprises a red flashing symbol.
Bolyard further teaches the external controller is configured to display battery depletion notifications indicated as green, yellow, red based on battery charge threshold levels of the plurality of batteries ( i.e. internal battery, removable battery and the third battery, e.g. Figs. 7A-C, 8, 9, [0076]-[0079], Fig. 6 shows states 170-194 of the power sources connected to control and power source module 12, e.g. removable battery 24, internal battery 80, and external power source connected via port 62). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Marseille in view of Bolyard and display the status levels as red or yellow flashing lights of all the batteries based on the depletion status in order to provide the predictable results of in order to provide the predictable results of improving safety by providing a user friendly device that warns the patient of the battery state as the battery depletion progresses.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US 11824381. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is anticipated by or obvious over and overlaps the subject matter of US Patent No US 11824381. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 12212167. Although the claims at issue are not identical, they are not patentably distinct from each other because the
the instant application is anticipated by or obvious over and overlaps the subject matter of US Patent No US 12212167. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 11179558. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is anticipated by or obvious over and overlaps the subject matter of US Patent No US 11179558. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kimball et al (U.S. Patent Application Publication Number: US 2015/0294550 A1, hereinafter “Kimball”) teaches a method for outputting a combined power source alarm for an implantable blood pump and includes determining a status for each of first and second power sources of the blood pump. The combined power source alarm is a flashing red or yellow light or an audio tone (e.g. [0018]-[0021]) based on a determined status of the power sources (e.g. [0017]).
Dague et al (U.S. Patent Application Publication Number: US 2011/0160516 A1, hereinafter “Dague”) teaches an implantable blood pump and a percutaneous extension and a first implantable housing that includes a rechargeable power storage device that supplies electrical power to the implantable blood pump. ( e.g Figs.2,3A). The percutaneous extension is configured to releasably connect to an external power supply adapted to provide power for recharging or supplementing the rechargeable power storage device to power the implantable blood pump.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
