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 Objections
Claim 16 objected to because of the following informalities:
Claim limitation: “comprised of a hydrophobic material or a combination of a hydrophilic material and a hydrophilic material” should read “comprised of a hydrophobic material or a combination of a hydrophilic material and a hydrophobic material” according to the comments provided in the remarks filed 06/16/2026, page 11 and [0057] of instant specification. Appropriate correction is required.
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 16-20, 27, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Banister et al (US 20100268200 A1) in view of Klemm et al. (US 20190307954 A1) in further view of Bassuk et al. (US 20030171710 A1).
Regarding claim 16, Banister discloses a wearable device (Device of Fig 1 could be implantable ([0060]);or non-implantable, [0022]; in both cases, the device is structurally capable to be wearable by the user) for metering fluids to a wearer (user of device of Fig 1), said device comprising (Figs 1-2; [0032]); a rigid or semi rigid outer shell (exterior shell 8, Fig 1); at least one metered fluid chamber (chamber 1000, Annotated Fig 1; [0098]) having at least one inlet, at least one outlet (one inlet or outlet port, claim 1; [0097]), and at least one sidewall (side wall 1001, Annotated Fig 1, claim 1), wherein an interior of the sidewall is in contact with and retains or separates fluid (fluid or gas volume 6, Fig 1) in the fluid chamber (1000, Annotated Fig 1) from other components of the device (Figs 1-2), said device comprising at least one actuator assembly (assembly actuator: actuator material 1+ wicking material; claim 88, [0098]; claim 1) comprising a flexible inner shell (actuator material 1, Fig 2) containing at least one polymer actuator material ([0097]) comprised of a hydrophobic material or a combination of a hydrophilic material and a hydrophilic material ([0015])and a wicking material in contact with the polymer actuator material (claim 88), wherein said polymer actuator material (1) is configured to expand in volume upon being contacted by a polymer actuator hydrating solution (chemical composition of the solution (4) hydrating the actuator material, Fig 4); said actuator assembly (actuator assembly; [0098]; claim 1) having an inlet (inlets from which the hydrates solution enters after passing through a gate; [0007]) configured to provide a fluid path for the polymer actuator hydrating solution (solution 4 hydrating the actuator material 1, [0097]) from a reservoir (actuator hydrating solution reservoir, claim 1) of said hydrating solutions (4) to the polymer actuator material (1); a connector (connector where the fluid gate is located, clam 1) configured to allow introduction of a hydrating solution (4) into the actuator assembly (actuator assembly; [0098]; claim 1) ; at least one platen (plunger material 5, Fig 1) located between an exterior wall of the actuator assembly outer shell (1002, Annotated Fig 2) and an exterior wall the metered fluid chamber (1003, Annotated Fig 2) (See annotated Fig 2); the actuator hydrating solution reservoir (actuator hydrating solution reservoir, claim 1) having one or more inlets (inlet port of hydrating solution reservoir, claim 1) or outlets, in fluid communication via a fluid path for delivering the actuator hydrating solution (4) to the polymer actuator assembly (actuator assembly; [0098]; claim 1); and a fluid gate (fluid gate, claim 1) configured to open or close the fluid path between the hydrating solution reservoir and the actuator assembly (claim 88: wherein the fluid gate can be opened and closed like a valve), effectively keeping the actuator material dry until the fluid gate is opened (claim 1: “ (…) a fluid gate located at some point between actuator hydrating solution reservoir and the polymer actuator, effectively keeping actuator dry”); wherein the rigid or semi rigid external shell (8) is configured to encase the actuator assembly (actuator assembly; [0098]; claim 1) (Fig 1-2), the platen (5) and the metered fluid chamber (1000, Annotated Fig 1) and hold all components other than the hydration solution reservoir (Fig 1), whereby the polymer actuator material (1), once hydrated is configured to expand and apply pressure to the at least one platen (5) which in turn in contact with the fluid chamber (1000, Annotated Fig 1), applies pressure to the fluid chamber (1000, Annotated Fig 1) whereby to force fluid from fluid (6) chamber (1000, Annotated Fig 1),
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Banister further discloses a one way valve (one way valve, not shown; [0112]).
Banister is silent regarding the one way valve configured to allow flow of hydrating fluid into but not out of the actuator assembly and wherein the device rigid or semi-rigid exterior case has a door or hatch configured to cover the two fill ports and latch closed when the fluid chamber is filled and the actuator activated, so that the device cannot be reopened during the use.
Klemm teaches a device (Fig 2) comprising an actuator assembly (3000, Annotated Fig 3) including a one way valve (non-return valve or check valve 28, Fig 2) configured to allow flow of a fluid into but not out of the actuator assembly ([0048]).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Banister with similar one way check valve in the input conduit of actuator assembly the as taught by Klemm for the purpose of preventing fluid from exiting the actuator assembly ([0048]).
Banister/Klemm are silent wherein the device rigid or semi-rigid exterior case has a door or hatch configured to cover the two fill ports and latch closed when the fluid chamber is filled and the actuator activated, so that the device cannot be reopened during the use.
Bassuk teaches a wearable device (Fig 2) wherein the device rigid or semi-rigid exterior case (housing 44, Fig 5) has a door or hatch (hinged lid 60, Fig 4) configured to cover the two fill ports (lid 60 covers two recessed ports 58, Fig 4) and latch closed when the fluid chamber is filled (fluid chamber defined by recess portion , claim 20; Fig 4; and the actuator activated, so that the device cannot be reopened during the use ([0056]: locking mechanism of lid 60 prevents opening during use).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Banister/Klemm with similar hinged lid covering the two fill ports as taught by Bassuk for the purpose of locking the device port access when delivery is taking place ([0056]).
Regarding claim 17, Banister/Klemm/Bassuk discloses the device of claim 16. Banister discloses where the fluid chamber and/or the polymer actuator assembly and/or the hydration solution reservoir is/are removable (claim 88: “(…) wherein the fluid chamber is removable”).
Regarding claim 18, Banister/Klemm/Bassuk discloses the device of claim 16. Banister discloses characterized by one or more of the following features: (a) wherein the fluid chamber inlet is capped or sealed by a pierceable septum (claim 88: “ (…) wherein one or more of the fluid chambers inlet/outlet ports are capped or sealed by a pierce able septum”); (b) wherein the fluid gate is configured to open or close by piercing, dissolving, tearing, pushing, bursting, pinching the connector, or by pulling the fluid gate out of the way of the hydrating solution path to allow path of hydration fluid to the polymer actuator.
Regarding claim 19, Banister/Klemm/Bassuk discloses the device of claim 16. Banister discloses characterized by one or more of the following features: (a) wherein the metered fluid chamber (1000, Annotated Fig 1) is configured for filling in the device (chamber 1000, annotated Fig 1, has inlet port structurally capable of permitting filling of the device; claim 1); (b) wherein the metered fluid chamber is configured for filling via an injection of fluid into the septum and fluid in the metered fluid chamber is released through to a desired wearer contact point; and (c) said device optionally further comprising a subcutaneous needle, an intramuscular needle, an intravenous needle, a catheter or a luer connection configured to allow metering of released fluid directly to a desired contact point of a wearer.
Regarding claim 20, Banister/Klemm/Bassuk discloses the device of claim 16. Banister discloses characterized by one or more of the following features: (a) wherein the actuator material has varying layers of density and porosity (Claim 88: “ (…) wherein the actuator material has varying layers of density and porosity”); (b) wherein the actuator material has both reacted and unreacted molecular sites, preferably varying degrees of reacted and unreacted molecular sites; (c) wherein the actuator hydrating solution comprises a combination of actuator materials having a ratio of reacted to unreacted molecular sites selected to determine a speed and pressure generation of the actuator material, and preferably wherein protonation of reactive molecular sites within the actuator material, by interaction with the actuator hydrating solution or chemical byproduct of that interaction, determines the speed and pressure generation of the actuator material; (d) wherein the actuator materials are selected by density or porosity to determine a speed and pressure generation of the actuator material; (e) wherein the actuator material surface in fluid contact with the actuator hydrating solution material is configured to determine a speed and pressure generation of the actuator; and (f) wherein the actuator hydrating solution pH or chemical makeup is selected to determine a speed and pressure generation of the actuator material.
Regarding claim 27, Banister/Klemm/Bassuk discloses the device of claim 16. Banister discloses wherein the fluid in the fluid chamber comprises a medication, a therapeutic material, a gene therapy or a protein, and optionally wherein said device is configured to deliver said medication, therapeutic material, gene therapy or protein to a predetermined site on or in a patient ([0090]; Claim 88: “wherein the fluid in the fluid chamber is a medicine or has therapeutic value”).
Regarding claim 31, Banister/Klemm/Bassuk discloses the device of claim 16. Banister discloses wherein the fluid gate comprises a mechanical valve ([0019]).
Regarding claim 32, Banister/Klemm/Bassuk discloses the device of claim 16. Banister is silent regarding further comprising tubing removably attached to the device for introducing hydrating solution into the device.
Klemm teaches the device (Fig 2) further comprising tubing (line 26, Fig 2) removably attached to the device (medicament delivery device 110, Fig 2) for introducing a hydrating solution (water inside chamber 15, Fig 2; [0047]) into the device (110) (line 26 is structurally capable of being removably attached to valve 28 and rest of device 110 when replacement is needed).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Banister/Klemm/Bassuk with similar line as taught by Klemm for the purpose of filling the actuator chamber with the liquid required for dispensing the medicament ([0047]).
Claims 21 is rejected under 35 U.S.C. 103 as being unpatentable over Banister et al (US 20100268200 A1) in view of Klemm et al. (US 20190307954 A1) in further view of Bassuk et al. (US 20030171710 A1) in further view of Gyory (US 20140135699 A1).
Regarding claim 21, Banister/Klemm/Bassuk discloses the device of claim 16. Banister is silent regarding characterized by one or more of the following features: (a) the device rigid or semi rigid exterior case has one or more windows configured to allow visualization of a metered fluid volume indicator; and (b) wherein the device rigid or semi-rigid exterior case has an interior pocket configured to shield and protect outlet tubing running from the exterior case, and wherein the outlet tubing has a flow restrictor or anti siphon valve in the fluid path to stop un-authorized removal or theft of medications from the device; (c) wherein the rigid or semi rigid outer shell comprises a syringe.
Gyory teaches a device a device ([0051]) comprising a rigid or semi rigid exterior case (the top housing 242, Fig 2) has one or more windows (visualization window; [0051]) configured to allow visualization of a metered fluid volume indicator (fluid level indicator 244).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Banister/Klemm/Bassuk with similar visualization window and metered fluid volume indicator as taught by Gyory for the purpose of indicating the percentage and volume of fluid delivered as well as volume remaining in the reservoir ([0051]).
Claims 22-23 is rejected under 35 U.S.C. 103 as being unpatentable over Banister et al (US 20100268200 A1) in view of Klemm et al. (US 20190307954 A1) in further view of Bassuk et al. (US 20030171710 A1) in further view of Davis et al. (US 20140276415 A1).
Regarding claim 22, Banister/Klemm/Bassuk discloses the device of claim 16. Banister discloses wherein the actuator hydrating solution container is contained within the outer shell (8) of the device (Fig, 1) (Claim 88: “(…)porous actuator housing, actuator hydrating solution reservoir are enclosed together as a sealed unit with an elastic membrane”); and wherein the device optionally is configured so that shutting the clam shell activates the metering device, and wherein activation triggers a spring loaded subcutaneous needle and canula to project through a side of the exterior case into a wearer's skin, wherein the needle is configured to retract back into the exterior case in the same action, leaving the canula in a subcutaneous layer below the skin of the wearer and in fluid connectivity to the fluid chamber (underlined claimed language is directed to an optional configuration).
Banister is silent regarding the outer shell is hinged like a clam shell and is configured to release the actuator hydrating solution into the actuator assembly when the outer shell is shut.
Davis teaches a device (Fig 4) comprising an outer shell (rigid, fixed volume housing 247, Fig 7A) is hinged like a clam shell ([0040]: “The housing 247 can include halves 247a, 247b coupled together by one or more hinge elements 249 and a closure mechanism 248”) and is configured to release the actuator solution (solution from drive fluid reservoir 230) into the actuator assembly (drive chamber 235 and divider 240) when the outer shell is shut (the housing 247 needs to be closed for the device to function as intended and the actuator fluid from 230 be released into the actuator assembly 235+240).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the shell of device of Banister/Klemm/Bassuk with similar hinged structure as taught by Davis for the purpose of facilitating opening and closing of the device ([0040]).
Regarding claim 23, Banister/Klemm/Bassuk/Davis discloses the device in claim 22. Banister discloses a septum configured to be pierced (septum; [0022]).
Banister is silent wherein the device is configured so the action of closing the device additionally pierces a septum or housing of a prefilled fluid container thereby making fluid connectivity between prefilled fluid container and subcutaneous fluid exit point.
Davis teaches a device (Fig 4) comprising an outer shell (rigid, fixed volume housing 247, Fig 7A) is hinged like a clam shell ([0040]).
Banister/Klemm/Bassuk/Davis as modified teaches the device configured so the action of closing the device additionally pierces a septum or housing of a prefilled fluid container (The exterior shell 8 of Banister is modified with teaching of Davis to open and close via a hinge mechanism. The device is structured to function when the shell 8 of Banister, modified with teaching of Davis, is in the closed position. Before the device is used, the shell 8 needs to be closed. The action of closing is necessary for the septum ([0022] of Banister) to be pierced).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the shell of device of Banister/Klemm/Bassuk with similar hinged structure as taught by Davis for the purpose of facilitating opening and closing of the device ([0040]).
Claims 24 is rejected under 35 U.S.C. 103 as being unpatentable over Banister et al (US 20100268200 A1) in view of Klemm et al. (US 20190307954 A1) in further view of Bassuk et al. (US 20030171710 A1) in further view of Banister et al. (US 20120029430 A1), hereinafter Banister-2.
Regarding claim 24, Banister/Klemm/Bassuk discloses the device of claim 16. Banister/Klemm/Bassuk are silent wherein the actuator is electrically activatable and the actuator assembly includes electrodes configured to eliminate electrolysis gas production at the electrodes via a double layer capacitor, and wherein said device also contains a power source and electrical controller connected to the actuator.
Banister-2 teaches a device (Fig 4) comprising an actuator (actuator assembly; [0032], [0073]) is electrically activatable ([0032]) and the actuator assembly includes electrodes configured to eliminate electrolysis gas production at the electrodes (electrodes; [0073]) ([0074]: “Once the discharge occurs, the charging process starts again, thereby eliminating gas generation at the electrode by using charge and discharge cycles”) via a double layer capacitor (claim 43; [0032]), and wherein said device also contains a power source and electrical controller (controller and power source [0073]) connected to the actuator ([0032]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Banister/Klemm/Bassuk with similar electrically activable actuator having electrode comprising a double layer capacitor as taught by Banister-2 for the purpose of providing improvement to the actuator ([0032]) and eliminate gas generation ([0073]-[0074]).
Claims 25 is rejected under 35 U.S.C. 103 as being unpatentable over Banister et al (US 20100268200 A1) in view of Klemm et al. (US 20190307954 A1) in further view of Bassuk et al. (US 20030171710 A1) in further view of Banister et al. (US 20120029430 A1), hereinafter Banister-2, in further view of Couvillon et al. (US 20040068224 A1).
Regarding claim 25, Banister/Klemm/Bassuk discloses the device of claim 16. Banister/Klemm/Bassuk are silent wherein the actuator is electrically activatable and the actuator assembly includes electrodes configured to eliminate electrolysis gas production at the electrodes via a carbon double layer capacitor, and wherein said device also contains a power source and electrical controller connected to the actuator and said controller is in wireless communication with a sensor and or hand held device wireless device.
Banister-2 teaches a device (Fig 4) comprising the actuator (actuator assembly; [0032],[0073]) is electrically activatable ([0032]) and the actuator assembly includes electrodes (electrodes; [0073]) configured to eliminate electrolysis gas production ([0074]: “Once the discharge occurs, the charging process starts again, thereby eliminating gas generation at the electrode by using charge and discharge cycles”) at the electrodes via a carbon double layer capacitor (claim 43; [0032]), and wherein said device also contains a power source and electrical controller (controller and power source [0073]) connected to the actuator (actuator assembly; [0032],[0073]) and said controller is in communication with a sensor (claim 20-21) and or hand held device wireless device.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Banister/Klemm/Bassuk with similar electrically activable actuator having electrode comprising a double layer capacitor as taught by Banister-2 for the purpose of providing improvement to the actuator ([0032]) and eliminate gas generation ([0073]-[0074]).
Banister/Klemm/Bassuk/Banister-2 are silent wherein the communication of the controller with the sensor is wireless.
Couvillon teaches a device comprising a controller is in wireless communication with a sensor ([0080]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Banister/Klemm/Bassuk/Banister-2 with similar wireless communication between the controller and the sensor as taught by Couvillon, for the purpose of improving user experience, facilitating mobility and portability ([0083]; [0080]).
Response to Arguments
Applicant’s arguments with respect to claims 19-32 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
