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 the Claims
Claims filed 08/25/2023 has been entered. Claims 1-15 and 20-24 are pending and under consideration.
Claim Objections
Claim 22 is objected to because of the following informalities:
Claim 22 line 2 recites “the suprachoroidal space” which should read “a suprachoroidal space”
Appropriate correction is required.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dos Santos et al (US 20140046439 A1, hereinafter ‘Santos’)
Regarding claim 1, Santos teaches an implantable active micro-shunt (figures 2-4, [0034], [0039] and [0043], Ocular implant or drainage device 350 comprising IOP control system 200 and MEMS package 400), comprising an actuation and sensing module (figure 2, IOP control system 200), wherein the actuation and sensing module is configured to detect intraocular pressure (IOP) and actuate flow to a suprachoridal space of a subject ([0029]-[0032], [0038] and figures 2-3, the IOP control system 200 is configured to be implanted within suprachoridal space, and the system comprising a sensor system 210 configured to measure intraocular pressure and shunt aqueous humor from anterior chamber to the suprachoroidal space).
Regarding claim 2, Santos teaches the implantable active micro-shunt of claim 1.
Santos further teaches comprising a flexible housing ([0034]-[0035] drainage device 350 comprising flexible plate)
Regarding claim 3, Santos teaches the implantable active micro-shunt of claim 1.
Santos further teaches wherein the actuation and sensing comprises a plurality of laminar layers (figure 4 and [0047]-[0048], MEMS package 400 comprising outer layers 410 and 430 and active layers 420).
Regarding claim 4, Santos teaches the implantable active micro-shunt of claim 3.
Santos further teaches wherein the plurality of laminar layers comprises a microelectromechanical systems ([0007], [0047]-[0048] layers 410, 420 and 430 forms micro-electromechanical systems).
Regarding claim 5, Santos teaches the implantable active micro-shunt of claim 3.
Santos further teaches wherein the plurality of laminar layers comprises an energy storage component (figure 2, [0034] and [0039] MEMS package 400 forms a part of plate 300, and the plate 300 include power source 205)
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Santos (US 20140046439 A1) in view of Tu (US 20050049578 A1).
Regarding claim 6, Santos teaches the implantable active micro-shunt of claim 3.
Santos further teaches wherein the plurality of laminar layers comprises an active drainage layer (figure 7 and [0039], active portion 420 includes a channel 421 which coupled to outlet tube 302 that drains aqueous humor).
Santos does not teach the active drainage layer comprising at least one electrode.
In the same field of endeavor, namely an implantable ocular pump to reduce intraocular pressure, Tu teaches the active drainage layer (figure 18a, tube 111) comprising at least one electrode (figure 18a, electrodes 114a-b).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos to incorporate the teachings of Tu and provides the active drainage layer as claimed for the purpose of proving a precise-volume flow as taught by Tu ([0137]). Furthermore, such configuration eliminates the need for moving mechanical parts, e.g., membrane, resulting in a more compact design and increased reliability.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Santos (US 20140046439 A1) in view of Adams (US 20220054007 A1).
Regarding claim 7, Santos teaches the implantable active micro-shunt of claim 3.
Santos does not teach wherein the plurality of laminar layers comprises an application specific integrated circuit.
In the same field of endeavor, namely an implantable intraocular pressure sensors and calibration, Adams teaches wherein the plurality of laminar layers comprises an application specific integrated circuit (figure 1 and [0033], ASIC/sensor 32).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos to incorporate the teachings of Adams and provides the application specific integrated circuit as claimed, and one of skill in the art motivated to do so, for the purpose of optimizing circuit design for the specific medical procedure, thereby enabling a reducing in both the overall dimensions and cost of the device.
Claims 8-15 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Santos (US 20140046439 A1) in view of Adams (US 20220054007 A1) and Tu (US 20050049578 A1).
Examiner’s note: the term ‘electrohydrodynamic’ is interpreted as equivalent to ‘electrokinetic’, where the application of an electric field induces a force on liquid or fluid (such as aqueous humor) with a net electrical charge (i.e., positive or negative) that causes flow without any mechanically moving parts disclosed in specification [0069]
Regarding claim 8, Santos substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
An implantable active micro-pump device (figures 2-4, [0034], [0039] and [0043], ocular implant or drainage device 350 comprising IOP control system 200 and MEMS package 400), comprising:
a) an active channel portion (figure4 and [0047]-[0048] MEMS package 400); and
b) an actuation and sensing module (figure 2, IOP control system 200), comprising:
i) a pressure sensor ([0029]-[0032] and [0038], figures 2-3, IOP control system 200 comprising a sensor system 210 measures intraocular pressure) configured to detect intraocular pressure (IOP);
ii) a stored energy component (figure 2, power source 205); and
iii) an application specific integrated circuit (ASIC) a processor (figure 2, 215 and 220) in operational communication with the active channel portion, stored energy component and pressure sensor ([0027]-[0028], [0031] and [0042] MEMS package 400, power source 205, and sensor system 210 are in operational communication with the processor 215 ),
wherein the ASIC is configured to actuate electrohydrodynamic actuation of fluid in the active channel portion in response to detected IOP via the stored energy component
Santos does not teach the actuation and sensing module comprising an application specific integrated circuit (ASIC).
In the same field of endeavor, namely an implantable intraocular pressure sensors and calibration, Adams teaches wherein the actuation and sensing module (figure 1, first portion 12) comprises an application specific integrated circuit (figure 1 and [0033], ASIC/sensor 32).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos to incorporate the teachings of Adams and provides the application specific integrated circuit as claimed, and one of skill in the art motivated to do so, for the purpose of optimizing circuit design for the specific medical procedure, thereby enabling a reducing in both the overall dimensions and cost of the device.
The combination is still silent as to wherein the ASIC is configured to actuate electrohydrodynamic actuation of fluid in the active channel portion in response to detected IOP via the stored energy component.
In the same field of endeavor, namely an implantable ocular pump to reduce intraocular pressure, Tu teaches wherein the ASIC is configured to actuate electrohydrodynamic actuation of fluid in the active channel portion in response to detected IOP via the stored energy component (figures 8c, 18a, [0095] and [0134]-[0146], IOP sensor, controller and pumping element electrically coupled to the power source, and the power source supplies power to the pumping element in response to sensor input, the pump utilizing electrokinetic pumping to actuate electrohydrodynamic actuation of fluid)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos, as modified by Adam, to incorporate the teachings of Tu and provides the active channel portion as claimed for the purpose of proving a precise-volume flow as taught by Tu ([0137]). Furthermore, such configuration eliminates the need for moving mechanical parts, e.g., membrane, resulting in a more compact design and increased reliability.
Regarding claim 9, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 8.
The combination further teaches comprising a microelectromechanical systems in operational communication with the ASIC and active channel portion (Santos; figures2, 4 and [0043] ocular implant 350 comprising MEMS 400 in operational communication of processor 215 and active portion 420).
Regarding claim 10, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 9.
The combination does not teach further comprising one or more electrodes disposed in the active channel configured for electrohydrodynamic actuation.
In the same field of endeavor, namely an implantable ocular pump to reduce intraocular pressure, Tu teaches comprising one or more electrodes disposed in the active channel configured for electrohydrodynamic actuation (figure 18a and [0140], electrodes 114a and 114b disposed in the pump 110 configured to generate an electric filed induces flow of aqueous fluid namely electrohydrodynamic actuation)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos, as modified by Adam and Tu, to incorporate the teachings of Tu and provides the active channel portion as claimed for the purpose of proving a precise-volume flow as taught by Tu ([0137]). Furthermore, such configuration eliminates the need for moving mechanical parts, e.g., membrane, resulting in a more compact design and increased reliability.
Regarding claim 11, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 10.
The combination does not teach wherein the pressure sensor is capacitive pressure sensor comprising a membrane.
In the same field of endeavor, namely an implantable intraocular pressure sensors and calibration, Adams teaches wherein the pressure sensor is capacitive pressure sensor comprising a membrane (figure 13 and [0122] sensor comprises capacitative sensing element and flexible membrane).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos, as modified by Adam and Tu, to incorporate the teachings of Adams and provide the pressure sensor as claimed for the purpose of obtaining reliable measurements of IOP while eliminate the risk of ocular fluids coming in contact with the miniature electronic circuit boards as taught by Adam ([0120]).
Regarding claim 12, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 10.
The combination further teaches wherein the one or more electrodes are configured to actuate electrohydrodynamic fluid flow in response to applied voltage (Tu; [0146] pump 110 is activated by applying a voltage across the electrodes 114a and 114b)
Regarding claim 13, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 10.
The combination further teaches wherein the ASIC is in electrical communication with the one or more electrodes (Tu; figure 8c, 18a, [0095] and [0134]-[0146], pumping element 64 is electrically coupled to controller 62, the pumping element 64 include pump 110)
Regarding claim 14, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 10.
The combination does not teach further comprising a power and telemetry coil in operation communication with ASIC.
In the same field of endeavor, namely an implantable intraocular pressure sensors and calibration, Adams teaches comprising a power and telemetry coil (figure 17 [0033], [0226] and [0228] coiled antenna in electrical communication with ASIC through rechargeable power source,) in operation communication with ASIC.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos, as modified by Adams and Tu, to incorporate the teachings of Adams and provide the power and telemetry coil as claimed for the purpose of wireless data and power transfer with external device as taught by Adam ([0095] and [0147]).
Regarding claim 15, Santos teaches an implantable active device (figures 2-4, [0034], [0039] and [0043], ocular implant or drainage device 350 comprising IOP control system 200 and MEMS package 400), comprising:
a) an active channel portion (figure 4 and [0047]-[0048] channel formed by channel 421 and 401 and of MEMS package 400); and
b) an actuation and sensing module (figure 2, IOP control system 200), comprising:
i) a microelectromechanical systems (MEMS) (figure 2 and, [029]-[0032], [0038] and [0043] MEMS package 400 substituting and including valve system 230 comprising sensor system 210 measures intraocular pressure) configured to detect intraocular pressure (IOP) ) comprising a pressure sensor configured to detect intraocular pressure (IOP);
ii) a stored energy component (figure 2, power source 205); and
iii) an application specific integrated circuit (ASIC) an processor (figure 2, processor),
wherein the ASIC processor is in operational communication with the active channel portion, MEMS, stored energy component and pressure sensor (figure 2 and [0042] [0057], the processor 215 is in operational communication with active channel portion MEMS, power source and pressure sensor) and is configured to actuate electrohydrodynamic actuation of fluid in the active channel portion in response to detected IOP via the stored energy component
Santos does not teach the actuation and sensing module comprises an application specific integrated circuit (ASIC).
In the same field of endeavor, namely an implantable intraocular pressure sensors and calibration, Adams teaches wherein the actuation and sensing module (figure 1, first portion 12) comprises an application specific integrated circuit (figure 1 and [0033], ASIC/sensor 32).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos to incorporate the teachings of Adams and provides the application specific integrated circuit as claimed, and one of skill in the art motivated to do so, for the purpose of optimizing circuit design for the specific medical procedure, thereby enabling a reducing in both the overall dimensions and cost of the device.
The combination is still silent as to wherein the ASIC is configured to actuate electrohydrodynamic actuation of fluid in the active channel portion in response to detected IOP via the stored energy component.
In the same field of endeavor, namely an implantable ocular pump to reduce intraocular pressure, Tu teaches wherein the ASIC is configured to actuate electrohydrodynamic actuation of fluid in the active channel portion in response to detected IOP via the stored energy component (figures 8c, 18a, [0095] and [0134]-[0146], IOP sensor, controller and pumping element electrically coupled to the power source, and the power source supplies power to the pumping element in response to sensor input, the pump utilizing electrokinetic pumping to actuate electrohydrodynamic actuation of fluid)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos to incorporate the teachings of Tu and provides the active channel portion as claimed for the purpose of proving a precise-volume flow as taught by Tu ([0137]).
Regarding claim 20, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 15.
The combination does not teach wherein the pressure sensor comprises a membrane.
In the same field of endeavor, namely an implantable intraocular pressure sensors and calibration, Adams teaches wherein the pressure sensor is capacitive pressure sensor comprising a membrane (figure 13 and [0122] sensor comprises capacitative sensing element and flexible membrane).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos, as modified by Adam and Tu, to incorporate the teachings of Adams and provide the pressure sensor as claimed for the purpose of obtaining reliable measurements of IOP as taught by Adams while eliminate the risk of ocular fluids coming in contact with the miniature electronic circuit boards as taught by Adam ([0120]).
Regarding claim 21, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 15.
The combination does not teach wherein the actuation and sensing module is configured to actuate electro hydrodynamic actuation of fluid in the active channel portion via application of variable voltage
In the same field of endeavor, namely an implantable ocular pump to reduce intraocular pressure, Tu teaches wherein the actuation and sensing module is configured to actuate electro hydrodynamic actuation of fluid in the active channel portion via application of variable voltage (Tu; claim 39 [0095] the controller selectively applying a voltage to the at least one electrode. Examiner’s note: under broadest reasonable interpretation, “selectively applying a voltage” necessary means applying zero volts and the non-zero actuation voltage. Therefore, “selective” application of voltage inherently and necessarily applies a variable voltage (varies between 0 V and the actuation voltage ).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos, as modified by Adam and Tu, to incorporate the teachings of Tu and provide the actuation and sensing module as claimed for the purpose of selectively activate the pumping element to keep the IOP substantially equal to the target IOP level as taught by Tu ([0094])
Regarding claim 22, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 15.
The combination further teaches wherein the actuation and sensing module configured for implantation into a suprachoroidal space (Santos; figure 3, drainage device 350 is configured to be implanted within a suprachoroidal space)
Regarding claim 23, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 15.
The combination does not teach comprising a power and telemetry coil configured to communicate with a reader and charge the stored energy component.
In the same field of endeavor, namely an implantable intraocular pressure sensors and calibration, Adams teaches comprising a power and telemetry coil configured to communicate with a reader and charge the stored energy component (figure 17 [0033], and [0147] [0226] and [0228] coiled antenna is in communication with external interrogation devices that communicate with the implant and recharge the battery disposed in the implant).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Santos, as modified by Adams and Tu, to incorporate the teachings of Adams and provide the power and telemetry coil as claimed for the purpose of enabling wireless data and power transfer with external device as taught by Adam ([0095] and [0147]).
Regarding claim 24, Santos, as modified by Adams and Tu, teaches the implantable active micro-pump device of claim 15.
The combination further teaches wherein the active channel portion and actuation and sensing module are disposed within a housing (Santos; figure 2 and 3, drainage device 350 include figure 2, IOP control system 200 and MEMS package including the active channel portion therein)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gelvin (US 20160296371 A1) is cited as disclosing implant configured to control IOP.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/ Examiner, Art Unit 3781