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 .
Information Disclosure Statement
The information disclosure statement filed 31 January 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because JP-2017064525 has no translation. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claims 1-33 are objected to because of the following informalities (for clarity, the following phrases should be amended throughout the claim-set):
“first and second wafers” should be “a first wafer and a second wafer”
“the inlet and outlet ports” should be “the inlet port and the outlet port”
“the first, second and third chambers” should be “the first chamber, the second chamber and the third chamber”
“the first and second chambers” should be “the first chamber and the second chamber”
“the second and third chambers” should be “the second chamber and the third chamber”
“CGM” should be written out as “continuous glucose monitor”
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, 2, 4, 6-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fouillet et al (US 2012/0224981).
Regarding claim 1, Fouillet discloses:
A MEMS device (Figs. 2A-2E; ¶0001 – microfluidic device is a micropump) for a device (1) for delivering medicament into a subcutaneous tissue of a user (¶0011), the device for delivering medicament configured to be mounted to the user, the MEMS device including an inlet port (14) and outlet port (15), the MEMS device configured as a micropump (¶0067) to pump the medicament from the inlet port (14) to the outlet port (15) (¶0088), the MEMS device comprising: first and second wafers (20, 10) that define a cavity (combined cavities 24.1, 24.2, 24.3, 12.1, 12.2, 12.3, 13) therebetween that communicates with the inlet and outlet ports (14, 15) (¶0087), thereby creating a fluid path for a flow of the medicament from the inlet port (14) to the outlet port (15) (¶0087), the first wafer (20) configured as a membrane (¶0100, 0108), the cavity comprises: a first chamber (12.2) configured as a pumping chamber (¶0079) of the micropump (1); and a second chamber (12.1) and a third chamber (12.3) configured as valve chambers (¶0079) of the micropump (1), wherein the second chamber (12.1) communicates with the first chamber (12.2) and the inlet port (14) and the third chamber (12.3) communicates with the first chamber (12.2) and the outlet port (15) and wherein the first, second chamber and third chamber (12.2, 12.1, 12.3) form the fluid path through the micropump (1) from the inlet port (14) to the outlet port (15) (¶0079, 0085), wherein the first wafer (20) as a membrane is configured to deflect creating a pressure difference within the cavity (¶0109) and thereby draw medicament from the inlet port (14) into the first chamber (12.2) or displace medicament from the first chamber (12.2) toward the outlet port (15) (¶0109).
Regarding claim 2, Fouillet discloses:
The MEMS device of claim 1 wherein the first, second and third chambers (12.2, 12.1, 12.3) are configured as first, second and third circular sections (Fig. 3) with connecting channels (13) between the first and second chambers (12.1, 12.1) and the first and third chambers (12.2, 12.3).
Regarding claim 4, Fouillet discloses:
The MEMS device of claim 2 wherein the first chamber (12.2) has a diameter that is greater than diameters of the second and third chambers (12.1, 12.3) (Fig. 3).
Regarding claim 6, Fouillet discloses:
The MEMS device of claim 1 further comprising a pump section (20; Fig. 2E) including a piezoelectric actuator (31) layered on the first wafer (20) over the first chamber (12.2), the piezoelectric actuator (31) configured to deform the first wafer (20) to draw into or displace medicament from the first chamber (Fig. 6; ¶0116 – in this exemplary figure, the actuated piezoelectric actuator 31 deforms, which deforms the first wafer 20 above the corresponding chamber, which can be first chamber 12.2) and first and second valve sections (chips 31 above second and third chambers 12.1, 12.3), each including a piezoelectric actuator (31) layered on the first wafer (20) over the second and third chambers (12.1, 12.3).
Regarding claim 7, Fouillet discloses:
The MEMS device of claim 6 wherein the first and second valve sections (chips 31 above second and third chambers 12.1, 12.3) further include first and second valve seats (16), respectively that extend into the second and third chambers (12.1, 12.3) (see Fig. 3), respectively, the first and second valve seats (16) define an introduction to first and second channels from the inlet and outlet ports (14, 15), respectfully (¶0088), the first piezoelectric actuators (31) of the first and second valve sections configured to compress the first wafer (20) to reach and seal the first and second valve seats (16) to thereby discontinue flow through the inlet and outlet ports (14, 15) (¶0109, 0118).
Regarding claim 8, Fouillet discloses:
The MEMS device of claim 6 wherein the first wafer (20) and the first, second and third chambers (12.2, 12.1, 12.3) are configured to maximize stroke volume while overcoming back pressure through the micropump (¶0080).
Regarding claim 10, Fouillet discloses the MEMS device of claim 1 wherein the medicament is fully capable of being insulin (¶0002).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fouillet in view of White et al (US 2020/0088716).
Regarding claim 3, Fouillet discloses the MEMS device of claim 2 but is silent regarding “the connecting channels are tapered and comprise curved edges to prevent bubble generation within the fluid path.” However, White teaches a microfluidic device (Abstract), thus being in the same field of endeavor, that connects different chambers with a connecting channel (124; Fig. 9) that has tapered, or funnel shaped, ends and curved edges in order to have a constant slope to prevent bubbles from forming and getting trapped in the channel (¶0054-0056). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with tapered channels and curved edges as taught by White in order to provide sufficient structure to prevent air bubbles and clogging, as recognized by White.
Claims 5, 9, 11-13, 15, 17-20, 22, 24, 25, 28, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Fouillet in view of Richter et al (US 2005/0123420).
Regarding claim 5, Fouillet discloses the MEMS device of claim 2 but is silent regarding “the first, second and third chambers have equal diameters.” However, Richter teaches a peristaltic micropump (Abstract), thus being in the same field of endeavor, with two alternative arrangements: a layout (Fig. 6A) with a pumping chamber (14) that is larger than the valve chambers (12, 16), and a layout (Fig. 10b) with a pumping chamber (342) that is the same size as the valve chambers (360, 362). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the chambers of Fouillet to have chambers of equal diameters as taught by Richter as such a modification would the be result of one known element (the equal size layout of Richter) for another known element (the unequal size layout of Fouillet) in order to obtain predictable results (providing a pump with a desired flow rate).
Regarding claim 9, Fouillet discloses the MEMS device of claim 1 but is silent regarding “the second chamber has a diameter larger than the first chamber and third chamber and the first chamber has a diameter larger than the third diameter.” However, Richter teaches a peristaltic micropump (Abstract), thus being in the same field of endeavor, with two alternative arrangements: a layout (Fig. 6A) with a pumping chamber (14) that is larger than the valve chambers (12, 16), and a layout (Fig. 10b) with a pumping chamber (342) that is the same size as the valve chambers (360, 362). Richter further teaches that adjusting the dimensions of the pump chambers to adjust the compression ratio of the pump (¶0114). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the chambers of Fouillet to have the claimed relative sizes in order to tailor the compression ratio of the pump as desired by a user, as taught by Richter.
Regarding claim 11, Fouillet discloses:
A device (1; Figs. 1-2E; ¶0002 – the device is fully capable of delivering insulin to a user for diabetes management), the device (1) configured to be mounted the user, the device (1) comprising: a MEMS device (Figs. 2A-2E) configured as a micropump (¶0001 – microfluidic device is a micropump that is fully capable of pumping insulin through the micropump), the MEMS device comprising: an inlet port (14; fully capable of receiving the insulin) and outlet port (15; fully capable of releasing the insulin to supply); first and second wafers (20, 10) that define a cavity (combined cavities 24.1, 24.2, 24.3, 12.1, 12.2, 12.3, 13) that communicates with the inlet and outlet ports (14, 15), thereby creating a fluid path for a flow of the insulin from the inlet port (14) to the outlet port (15), the cavity including a first chamber (12.2) configured as a pump chamber (¶0079) and/or a valve chamber of the micropump (1) and a second chamber (12.1) configured as a pump chamber and/or a valve chamber (¶0079), the first chamber and second chamber (12.2, 12.1) in communication therewith creating the fluid path between the inlet and outlet ports (14, 15); a first piezoelectric actuator (31) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the first chamber (12.2) (Fig. 6; ¶0116 – in this exemplary figure, the actuated piezoelectric actuator 31 deforms, which deforms the first wafer 20 above the corresponding chamber, which can be first chamber 12.2); a second piezoelectric actuator (31) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the second chamber (12.1) (¶0116), wherein the first wafer (20) as a membrane is configured, upon deformation, to create a pressure difference within the cavity and thereby draw insulin from the inlet port (14) into the first chamber (12.2) and/or second chamber (12.1) or displace fluid from the first chamber (12.2) and/or second chamber (12.1) toward the outlet port (15) (¶0116).
Fouillet discloses all of the elements of the claim but is silent regarding “an infusion catheter for infusing the insulin into a subcutaneous tissue of the user” and “the MEMS device in fluid communication with the infusion catheter.” Fouillet instead demonstrates an unspecified connection in Fig. 1. However, Richter teaches a peristaltic micropump (Abstract), thus being in the same field of endeavor, with fittings (60; Fig. 1) connected to the inlet and outlet channels (54, 56) that are then attached to tubings for infusion (¶0037). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with an infusion catheter as taught by Richter in order to provide sufficient structure to infuse the medication into the patient.
Regarding claim 12, Fouillet in view of Richter discloses:
The device of claim 11 wherein the cavity of the MEMS device further comprising a third chamber (12.3) configured as a pump chamber (¶0079) of the micropump and a third piezoelectric actuator (31) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the third chamber (12.3) (¶0116).
Regarding claim 13, Fouillet in view of Richter discloses:
The device of claim 12 wherein the first, second and third second chambers (12.2, 12.1, 12.3) and first, second and third piezoelectric actuators (31) are configured to maximize stroke volume while overcoming back pressure through the micropump (¶0080).
Regarding claim 15, Fouillet in view of Richter discloses:
The MEMS device of claim 12 wherein the first, second and third chambers (12.2, 12.1, 12.3) are configured as first, second and third circular sections (Fig. 3) with connecting channels (13) between the first and second chambers (12.2, 12.1) and the first and third chambers (12.2, 12.3).
Regarding claim 17, Fouillet in view of Richter discloses:
The MEMS device of claim 12 wherein the first chamber (12.2) has a diameter that is greater than diameters of the second and third chambers (12.1, 12.3) (Fig. 3).
Regarding claim 18, Fouillet in view of Richter discloses the MEMS device of claim 11 but is silent regarding “the first and second chambers have equal diameters.” However, Richter further teaches two alternative arrangements: a layout (Fig. 6A) with a pumping chamber (14) that is larger than the valve chambers (12, 16), and a layout (Fig. 10b) with a pumping chamber (342) that is the same size as the valve chambers (360, 362). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the chambers of Fouillet to have chambers of equal diameters as taught by Richter as such a modification would the be result of one known element (the equal size layout of Richter) for another known element (the unequal size layout of Fouillet) in order to obtain predictable results (providing a pump with a desired flow rate).
Regarding claim 19, Fouillet discloses:
A device (1; Figs. 1-2E; ¶0002 – the device is fully capable of delivering insulin to a user for diabetes management), the device (1) configured to be mounted the user, the device (1) comprising: a MEMS device (Figs. 2A-2E) configured as a micropump (¶0001 – microfluidic device is a micropump that is fully capable of pumping insulin through the micropump), the MEMS device comprising: an inlet port (14; fully capable of receiving the insulin) and outlet port (15; fully capable of releasing the insulin to supply); first and second wafers (20, 10) that define a cavity (combined cavities 24.1, 24.2, 24.3, 12.1, 12.2, 12.3, 13) that communicates with the inlet and outlet ports (14, 15), thereby creating a fluid path for a flow of the insulin from the inlet port (14) to the outlet port (15), the cavity including a first chamber (12.2) configured as a pump chamber (¶0079), a second chamber (12.1) configured as a valve chamber (¶0079) and a third chamber (12.3) configured as a valve chamber (¶0079), the first chamber (12.2) in communication with the second chamber (12.1) and third chamber (12.3) therewith creating the fluid path between the inlet and outlet ports (14, 15); a first piezoelectric actuator (31 – actuator over the first chamber 12.2) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the first chamber (12.2) (Fig. 6; ¶0116 – in this exemplary figure, the actuated piezoelectric actuator 31 deforms, which deforms the first wafer 20 above the corresponding chamber, which can be first chamber 12.2); a second piezoelectric actuator (31 – actuator over the second chamber 12.1) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the second chamber (12.1); and a third piezoelectric actuator (31 – actuator over the third chamber 12.3) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the third chamber (12.3), wherein the first wafer (20) as a membrane is configured, upon deformation, to create a pressure difference within the cavity and thereby draw insulin from the inlet port (14) into the second chamber (12.1) or displace insulin from the first chamber (12.2) toward the outlet port (15) (¶0116).
Fouillet discloses all of the elements of the claim but is silent regarding “an infusion catheter for infusing the insulin into a subcutaneous tissue of the user” and “the MEMS device in fluid communication with the infusion catheter.” Fouillet instead demonstrates an unspecified connection in Fig. 1. However, Richter teaches a peristaltic micropump (Abstract), thus being in the same field of endeavor, with fittings (60; Fig. 1) connected to the inlet and outlet channels (54, 56) that are then attached to tubings for infusion (¶0037). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with an infusion catheter as taught by Richter in order to provide sufficient structure to infuse the medication into the patient.
Regarding claim 20, Fouillet in view of Richter discloses:
The device of claim 19 wherein the first, second and third second chambers (12.2, 12.1, 12.3) and first, second and third piezoelectric actuators (31) are configured to maximize stroke volume while overcoming back pressure through the micropump (¶0080).
Regarding claim 22, Fouillet in view of Richter discloses:
The MEMS device of claim 19 wherein the first, second and third chambers (12.2, 12.1, 12.3) are configured as first, second and third circular sections (Fig. 3) with connecting channels (13) between the first and second chambers (12.2, 12.1) and the first and third chambers (12.2, 12.3), respectively.
Regarding claim 24, Fouillet in view of Richter discloses:
The MEMS device of claim 22 wherein the first chamber (12.2) has a diameter that is greater than diameters of the second and third chambers (12.1, 12.3) (Fig. 3).
Regarding claim 25, Fouillet in view of Richter discloses the MEMS device of claim 22 but is silent regarding “the first and second chambers have equal diameters.” However, Richter further teaches two alternative arrangements: a layout (Fig. 6A) with a pumping chamber (14) that is larger than the valve chambers (12, 16), and a layout (Fig. 10b) with a pumping chamber (342) that is the same size as the valve chambers (360, 362). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the chambers of Fouillet to have chambers of equal diameters as taught by Richter as such a modification would the be result of one known element (the equal size layout of Richter) for another known element (the unequal size layout of Fouillet) in order to obtain predictable results (providing a pump with a desired flow rate).
Regarding claim 28, Fouillet discloses:
A device (1; Figs. 1-2E; ¶0002 – the device is fully capable of delivering insulin to a user for diabetes management), the device (1) configured to be mounted the user, the device (1) comprising: a MEMS device (Figs. 2A-2E) configured as a micropump (¶0001 – microfluidic device is a micropump that is fully capable of pumping insulin through the micropump), the MEMS device comprising: an inlet port (14; fully capable of receiving the insulin) and outlet port (15; fully capable of releasing the insulin to supply); first and second wafers (20, 10) that define a cavity (combined cavities 24.1, 24.2, 24.3, 12.1, 12.2, 12.3, 13) that communicates with the inlet and outlet ports (14, 15), thereby creating a fluid path for a flow of the insulin from the inlet port (14) to the outlet port (15), the cavity including a first chamber (12.2) configured as a pump chamber (¶0079) and as a circular section (Fig. 3), a second chamber (12.1) configured as a valve chamber (¶0079) and as a circular section (Fig. 3), a third chamber (12.3) configured as a valve chamber (¶0079) and as a circular section (Fig. 3), a first channel (13) between the first chamber (12.2) and second chamber (12.1) and a second channel (13) between the first chamber (12.2) and third chamber (12.3), the first and second channels (13) thereby enabling communication within the cavity and the flow of insulin between the inlet and outlet ports (14, 15); a first piezoelectric actuator (31 – actuator over the first chamber 12.2) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the first chamber (12.2) (Fig. 6; ¶0116 – in this exemplary figure, the actuated piezoelectric actuator 31 deforms, which deforms the first wafer 20 above the corresponding chamber, which can be first chamber 12.2); a second piezoelectric actuator (31 – actuator over the second chamber 12.1) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the second chamber (12.1); and a third piezoelectric actuator (31 – actuator over the third chamber 12.3) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the third chamber (12.3), wherein the first wafer (20) as a membrane is configured, upon deformation, to create a pressure difference within the cavity and thereby draw insulin from the inlet port (14) into the second chamber (12.1) or displace insulin from the first chamber (12.2) toward the outlet port (15) (¶0116).
Fouillet discloses all of the elements of the claim but is silent regarding “an infusion catheter for infusing the insulin into a subcutaneous tissue of the user” and “the MEMS device in fluid communication with the infusion catheter.” Fouillet instead demonstrates an unspecified connection in Fig. 1. However, Richter teaches a peristaltic micropump (Abstract), thus being in the same field of endeavor, with fittings (60; Fig. 1) connected to the inlet and outlet channels (54, 56) that are then attached to tubings for infusion (¶0037). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with an infusion catheter as taught by Richter in order to provide sufficient structure to infuse the medication into the patient.
Regarding claim 31, Fouillet in view of Richter discloses the device of claim 28 but is silent regarding “at least one of the first, second and third piezoelectric actuators is polygonal shaped to maximize volumetric deflection in first, second and third chambers respectively.” However, Richter further teaches that the piezoelectric actuators (22, 24, 26; Fig. 6a) are polygonal and maximize volumetric deflection (¶0036). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the piezoelectric actuators of Fouillet to be polygonal as taught by Richter as such a modification would be the result of a simple substitution of one known element (the polygonal actuators of Richter) for another known element (the circular actuators of Fouillet) in order to obtain predictable results (providing pump actuators).
Claim 14, 21, 26, 27, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Fouillet in view of Richter further in view of Amirouche et al (US 2013/0274577).
Regarding claim 14, Fouillet in view of Richter discloses the device of claim 11 but is silent regarding “a CGM sensor for measuring glucose level in the user.” However, Amirouche teaches a drug delivery device with a micropump (¶0080), thus being in the same field of endeavor, that uses a continuous glucose monitoring sensor (¶0100) in order to monitor a patient’s glucose when delivering insulin (¶0061). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with a CGM sensor as taught by Amirouche in order to provide sufficient structure to monitor a patient when treating them with insulin, as recognized by Amirouche.
Regarding claim 21, Fouillet in view of Richter discloses the device of claim 19 but is silent regarding “a CGM sensor for measuring glucose level in the user.” However, Amirouche teaches a drug delivery device with a micropump (¶0080), thus being in the same field of endeavor, that uses a continuous glucose monitoring sensor (¶0100) in order to monitor a patient’s glucose when delivering insulin (¶0061). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with a CGM sensor as taught by Amirouche in order to provide sufficient structure to monitor a patient when treating them with insulin, as recognized by Amirouche.
Regarding claim 26, Fouillet discloses:
A device (1; Figs. 1-2E; ¶0002 – the device is fully capable of delivering insulin to a user for diabetes management), the device (1) configured to be mounted the user, the device (1) comprising: a MEMS device (Figs. 2A-2E) configured as a micropump (¶0001 – microfluidic device is a micropump that is fully capable of pumping insulin through the micropump), the MEMS device comprising: an inlet port (14; fully capable of receiving the insulin) and outlet port (15; fully capable of releasing the insulin to supply); first and second wafers (20, 10) that define a cavity (combined cavities 24.1, 24.2, 24.3, 12.1, 12.2, 12.3, 13) that communicates with the inlet and outlet ports (14, 15), thereby creating a fluid path for a flow of the insulin from the inlet port (14) to the outlet port (15), the cavity including a first chamber (12.2) configured as a pump chamber (¶0079), a second chamber (12.1) configured as a valve chamber (¶0079) and a third chamber (12.3) configured as a valve chamber (¶0079), the first chamber (12.2) in communication with the second chamber (12.1) and third chamber (12.3) therewith creating the fluid path between the inlet and outlet ports (14, 15); a first piezoelectric actuator (31 – actuator over the first chamber 12.2) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the first chamber (12.2) (Fig. 6; ¶0116 – in this exemplary figure, the actuated piezoelectric actuator 31 deforms, which deforms the first wafer 20 above the corresponding chamber, which can be first chamber 12.2); a second piezoelectric actuator (31 – actuator over the second chamber 12.1) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the second chamber (12.1); and a third piezoelectric actuator (31 – actuator over the third chamber 12.3) layered on the first wafer (20) and configured to deform the first wafer (20) relative to the third chamber (12.3), wherein the first wafer (20) as a membrane is configured, upon deformation, to create a pressure difference within the cavity and thereby draw insulin from the inlet port (14) into the second chamber (12.1) or displace insulin from the first chamber (12.2) toward the outlet port (15) (¶0116).
Fouillet discloses all of the elements of the claim but is silent regarding “a sensor for sensing a biomarker in the user,” “an infusion catheter for infusing the insulin into a subcutaneous tissue of the user” and “the MEMS device in fluid communication with the infusion catheter.”
Regarding the “infusion catheter,” Fouillet instead demonstrates an unspecified connection in Fig. 1. However, Richter teaches a peristaltic micropump (Abstract), thus being in the same field of endeavor, with fittings (60; Fig. 1) connected to the inlet and outlet channels (54, 56) that are then attached to tubings for infusion (¶0037). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with an infusion catheter as taught by Richter in order to provide sufficient structure to infuse the medication into the patient.
Regarding “a sensor for sensing a biomarker in the user,” Amirouche teaches a drug delivery device with a micropump (¶0080), thus being in the same field of endeavor, that uses a continuous glucose monitoring sensor (¶0100) in order to monitor a patient’s glucose when delivering insulin (¶0061). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with a biomarker sensor as taught by Amirouche in order to provide sufficient structure to monitor a patient when treating them with a specific medication, as recognized by Amirouche.
Regarding claim 27, Fouillet in view of Richter and Amirouche discloses the device of claim 26, where Amirouche further teaches delivering a medicament of insulin and monitoring glucose level as detailed in the rejection of claim 26 above. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Fouillet to deliver insulin and monitor glucose level as taught by Amirouche in order to provide sufficient structure to treat diabetes.
Regarding claim 33, Fouillet in view of Richter discloses the device of claim 28 but is silent regarding “a CGM sensor for measuring glucose level in the user.” However, Amirouche teaches a drug delivery device with a micropump (¶0080), thus being in the same field of endeavor, that uses a continuous glucose monitoring sensor (¶0100) in order to monitor a patient’s glucose when delivering insulin (¶0061). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with a CGM sensor as taught by Amirouche in order to provide sufficient structure to monitor a patient when treating them with insulin, as recognized by Amirouche.
Claims 16, 23, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Fouillet in view of Richter further in view of White.
Regarding claim 16, Fouillet in view of Richter discloses the MEMS device of claim 15 but is silent regarding “the connecting channels are tapered and comprise curved edges to prevent bubble generation within the fluid path.” However, White teaches a microfluidic device (Abstract), thus being in the same field of endeavor, that connects different chambers with a connecting channel (124; Fig. 9) that has tapered, or funnel shaped, ends and curved edges in order to have a constant slope to prevent bubbles from forming and getting trapped in the channel (¶0054-0056). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with tapered channels and curved edges as taught by White in order to provide sufficient structure to prevent air bubbles and clogging, as recognized by White.
Regarding claim 23, Fouillet in view of Richter discloses the MEMS device of claim 22 but is silent regarding “the connecting channels are tapered and comprise curved edges to prevent bubble generation within the fluid path.” However, White teaches a microfluidic device (Abstract), thus being in the same field of endeavor, that connects different chambers with a connecting channel (124; Fig. 9) that has tapered, or funnel shaped, ends and curved edges in order to have a constant slope to prevent bubbles from forming and getting trapped in the channel (¶0054-0056). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with tapered channels and curved edges as taught by White in order to provide sufficient structure to prevent air bubbles and clogging, as recognized by White.
Regarding claim 29, Fouillet in view of Richter discloses the device of claim 28 but is silent regarding “the first and second channels have curved edges.” However, White teaches a microfluidic device (Abstract), thus being in the same field of endeavor, that connects different chambers with a connecting channel (124; Fig. 9) that has tapered, or funnel shaped, ends and curved edges in order to have a constant slope to prevent bubbles from forming and getting trapped in the channel (¶0054-0056). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with curved edges as taught by White in order to provide sufficient structure to prevent air bubbles and clogging, as recognized by White.
Regarding claim 30, Fouillet in view of Richter discloses the device of claim 28 but is silent regarding “the first and second channels are tapered and comprise curved edges.” However, White teaches a microfluidic device (Abstract), thus being in the same field of endeavor, that connects different chambers with a connecting channel (124; Fig. 9) that has tapered, or funnel shaped, ends and curved edges in order to have a constant slope to prevent bubbles from forming and getting trapped in the channel (¶0054-0056). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Fouillet with tapered channels and curved edges as taught by White in order to provide sufficient structure to prevent air bubbles and clogging, as recognized by White.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Fouillet in view of Richter (hereinafter Richter ‘420) further in view Richter et al (US 2017/0226994, hereinafter Richter ‘994).
Regarding claim 32, Fouillet in view of Richter ‘420 discloses the device of claim 28 but is silent regarding “wherein at least one of the first, second and third piezoelectric actuators is octagonal shaped to maximize volumetric deflection in first, second and third chambers respectively.” However, Richter ‘994 a micropump (Fig. 2A) with a piezoelectric actuator (210), thus being in the same field of endeavor, that teaches piezoelectric actuators of different shapes (Fig. 1C, ¶0082-0084) including a hexagonal shape (83; Fig. 1D). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the shape of the piezoelectric actuator of Fouillet in view of Richter ‘420 to be an octagon as taught by Richter ‘994 as such a modification would be the result of one known element (the octagonal shape of Richter ‘994) for another known element (the square shape of Richter ‘420) in order to obtain predictable results (providing a piezoelectric pump actuator).
Conclusion
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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