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 (IDS) submitted on 06/25/2024, 02/04/2025, 02/04/2025, 02/04/2025, 02/04/2025, 02/04/2025, and 02/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The applicant has included a number of Foreign References not included in IDS. These references include WO 2010/023567, WO 95/14497, WO 95/22363, WO 2013/021303.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because in FIG. 3 and FIG. 4, reference character “102-2” has been used to designate both circular section and, what the examiner believes to be.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include in FIG. 5 and FIG. 6, the following reference character not mentioned in the description: 104-2.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign mentioned in the description: thin section or membrane 102-5. In paragraph [0020] of the specification, the applicant does state that thin section or membrane 102-5 is not show in FIG. 5 and FIG. 6. However, the examiner feels that this component is necessary in understanding the claimed invention, and suggest modifying the drawings to depict reference sign 102-5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0019], the specification states “a two wafer structure”. In other parts of the specification, this phase is written as “two-wafer structure”. The examiner suggest adding the dash for continuity purposes.
In paragraph [0020], the specification states “…wherein bottom wafer 102 is etched to create microfluidic channel 102-1, circular section or opening 102-2 within the channel and inlet and outlet ports 102-3, 102-4 and top wafer 104 is configured to seal fluidic channel 102-1 created on bottom wafer 102-1.” The current way this sentence is written reads in a way that the top wafer if also etched from the bottom wafer. Further, it could be confusing to a reader not having the reference numbers for the inlet and outlet ports directly next to the component. The examiner suggest rewriting the sentence to be “…wherein bottom wafer 102 is etched to create microfluidic channel 102-1, circular section or opening 102-2 within the channel, inlet port 102-3, and outlet port 102-4. Top wafer 104 is configured to seal fluidic channel 102-1 created on bottom wafer 102-1.” to clear up any possible discrepancies in understanding.
In paragraph [0022], the specification states “outlet port 102-2”. However, previous reference to the outlet port use reference number “102-4”. The examiner suggest correcting “outlet port 102-2” to “outlet port 102-4” for continuity purposes.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: In the sixteenth and seventeenth lines of the claim, the claim states “a first wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports”. The manner in which this sentence is presented is confusing for the examiner to read. The sentence lacks proper grammar and is missing articles. The examiner suggest modifying the sentence to “a first wafer defining an inlet port, an outlet port, and a fluid channel communicating with the inlet and outlet ports” in order to correct grammar mistakes. Further, in the last line of the claim, the claim states “within channel”, but lacks any descriptors. The examiner assumes “channel” is the same as the previously mentioned “fluid channel”. Therefore, the last line of the claim should be modified to “within the fluid channel” for clarity purposes. Appropriate correction is required.
Claims 6 and 18 are objected to because of the following informalities: In the twelfth and thirteenth lines of the claims, the claims states “first wafer and second wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports”. The manner in which this sentence is presented is confusing for the examiner to read. The sentence lacks proper grammar and is missing articles. The examiner suggest modifying the sentence to “a first wafer and a second wafer defining an inlet port, an outlet port, and a fluid channel communicating with the inlet and outlet ports” in order to correct grammar mistakes. Further, in the last line of the claims, the claims state “within channel”, but lacks any descriptors. The examiner assumes “channel” is the same as the previously mentioned “fluid channel”. Therefore, the last line of the claims should be modified to “within the fluid channel” for clarity purposes. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: In the twelfth and thirteenth lines of the claim, the claim states “a first wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports”. The manner in which this sentence is presented is confusing for the examiner to read. The sentence lacks proper grammar and is missing articles. The examiner suggest modifying the sentence to “a first wafer defining an inlet port, an outlet port, and a fluid channel communicating with the inlet and outlet ports” in order to correct grammar mistakes. Further, in the last line of the claim, the claim states “within channel”, but lacks any descriptors. The examiner assumes “channel” is the same as the previously mentioned “fluid channel”. Therefore, the last line of the claim should be modified to “within the fluid channel” for clarity purposes. Appropriate correction is required.
Claims 2, 8, 14, and 20 are objected to because of the following informalities: The claims reference “the channel”, but lack the descriptor as to which channel. The examiner suggests modifying the claims to read “the fluid channel” for continuity with the independent claims. Appropriate correction is required.
Claims 5, 17, and 23 are objected to because of the following informalities: In the first line of the claims, the claim is missing a “the” before “first wafer”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: In the eighth line of the claim, the claim is missing a “the” before “catheter”. Appropriate correction is required.
Claims 7 and 19 are objected to because of the following informalities: The claims state “the wafer comprises the channel and an opening to the channel and the second wafer covers the opening in channel, thereby functioning as a wall to channel.”. The sentence reads as a run on thought and lacks descriptors for “channel”, which the examiner assumes is the same as the previously mentioned “fluid channel”. The examiner suggests modifying the claims to “the wafer comprises the fluid channel and an opening to the fluid channel, and the second wafer covers the opening in the fluid channel, thereby functioning as a wall to the fluid channel.” in order for the limitations of the claim to be clearer. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: In the third and sixth lines of the claim, the claim is missing a “the” before “medicament”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 9, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the thin section" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim. The examiner suggest fixing the dependency of the claim to resolve the rejection.
Claims 9 and 21 recite the limitation "the fluid" in the fourth line of each claim. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 6, 7, 12, 13, 18, 19, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid (United States Patent Application Publication No. US 2016/0361013 A1), and further in view of van Lintel (UK Patent Application No. GB 2248891 A) and Salman et al. (United States Patent No. US 10.739,175 B1; herein, Salman).
Regarding claim 1, Schmid discloses a device for delivering insulin to a user (host fluid (medication) delivery device 100), the device configured as a wearable apparatus or system (FIG. 44 displays delivery device 100 worn on a user) in which continuous glucose monitoring (CGM), insulin delivery and control functionality are provided to ensure insulin is delivered to the user ([0064]-[0065], device may also include integrated monitoring such as continuous glucose monitoring, device contains a fluid drive mechanism 150 for driving the fluid out of the reservoir 130, and device may include a circuit board 101 including a microcontroller), the device comprising: a reservoir (reservoir 130) for storing insulin ([0064], "a fluid reservoir 130 for holding a fluid"; [0062], fluid may be insulin); a catheter (cannula 176) configured to deliver insulin to a subcutaneous layer of the user ([0066], cannula is "capable of passing the fluid into the host"); an introducer needle (needle 174) movable with respect to the catheter (FIG. 4 to FIG. 6, [0066], needle is retractable with respect to cannula), the introducer needle configured to facilitate (a) insertion of the catheter into the subcutaneous layer of the user ([0066], "the introducer needle/trocar 174 may initially penetrate the skin such that both the introducer needle/trocar 174 and the cannula 176 are introduced (inserted) into the host") and (b) removal of the introducer needle to enable delivery of insulin through the catheter ([0066] "the introducer needle/trocar 174 may then be retracted within the cannula 176").
Schmid does not disclose a micropump, in fluid communication with the reservoir and the catheter, for pumping insulin from the reservoir through the catheter; and a pressure sensor separate from and in fluid communication with an outlet port of the micropump, the sensor comprising: a first wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports; a second wafer covering the fluid channel and including a pressure sensing mechanism; and a piezoelectric device layered on the second wafer and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure within channel.
However, van Lintel teaches a micropump (FIG. 3 and FIG. 4 entire embodiment is a micropump), in fluid communication with the reservoir and the catheter (FIG. 4, reservoir 24 connects to injection needle via conduit 21), for pumping insulin from the reservoir through the catheter (pg. 7 lines 28-32, when pressure increases, the pump flows liquid from the pump chamber out the outlet to the injection needle). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Schmid to include a micropump to pump insulin through the device to the injection site as taught by van Lintel in order to regulate the motion of liquid within the device (pg. 7 line 26 – pg. 8 line 4).
Schmid in view of van Lintel still does not disclose a pressure sensor separate from and in fluid communication with an outlet port of the micropump, the sensor comprising: a first wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports; a second wafer covering the fluid channel and including a pressure sensing mechanism; and a piezoelectric device layered on the second wafer and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure within channel.
However, Salman teaches a pressure sensor (FIG. 5, microflow sensor 10) separate from and in fluid communication with an outlet port of the micropump (col. 3 lines 60-66, "provides edge-to-edge flow" is interpreted by the examiner as having the ability to be connected to flow-providing elements), the sensor comprising: a first wafer (FIG. 4, cap wafer 20) defining an inlet port (FIG. 4, col. 3 lines 60-66, fluid inlet to extending flow channel 26 defined by edge 28), and outlet port (FIG. 4, col. 3 lines 60-66, fluid outlet from extending flow channel 26 defined by edge 30) and fluid channel (FIG. 4, extending flow channel 26) communicating with the inlet and outlet ports (FIG. 4); a second wafer (FIG. 3, base wafer 12) covering the fluid channel (FIG. 5, the flat upper surface 14 of base wafer 12 covers the extending flow channel 26 of cap wafer 20) and including a pressure sensing mechanism (FIG. 3 and FIG. 5, examiner is interpreting pressure sensing element to mean both the flow sensing element 18 and the section of base wafer 12 cut out to configure flow sensing element 18 to work); and a piezoelectric device (flow sensing element 18) layered on the second wafer (FIG. 3 and FIG. 5) and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure within channel (col. 4 lines 24-39, An input across the flow sensing element can be converted to an "electrical signal corresponding to a parameter of fluid flow". "The flow sensing element 18 can be any suitable type of flow sensing element", which could include a pressure sensing element). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Schmid to include a pressure sensor structured in a manner of having two wafers with a piezoelectric device layered on one of the wafer as taught by Salman in order that fluid flowing through the longitudinally extending flow channel passes across the sensing element (col. 2 lines 11-13).
Regarding claim 6, Schmid discloses a device for delivering insulin to a user (host fluid (medication) delivery device 100), the device configured as a wearable apparatus or system (FIG. 44 displays delivery device 100 worn on a user) in which continuous glucose monitoring (CGM), insulin delivery and control functionality are provided to ensure insulin is delivered to the user ([0064]-[0065], device may also include integrated monitoring such as continuous glucose monitoring, device contains a fluid drive mechanism 150 for driving the fluid out of the reservoir 130, and device may include a circuit board 101 including a microcontroller), the device comprising: a reservoir (reservoir 130) for storing insulin ([0064], "a fluid reservoir 130 for holding a fluid"; [0062], fluid may be insulin); a catheter (cannula 176) configured to deliver insulin to a subcutaneous layer of the user ([0066], cannula is "capable of passing the fluid into the host").
Schmid does not disclose a micropump, in fluid communication with the reservoir and catheter, for pumping insulin from the reservoir through the catheter; and a pressure sensor separate from and in fluid communication with an outlet port of the micropump, the sensor comprising: first wafer and second wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports; the second wafer including a pressure sensing mechanism; and a piezoelectric device layered on the second wafer and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure from the insulin within channel.
However, van Lintel teaches a micropump (FIG. 3 and FIG. 4 entire embodiment is a micropump), in fluid communication with the reservoir and the catheter (FIG. 4, reservoir 24 connects to injection needle via conduit 21), for pumping insulin from the reservoir through the catheter (pg. 7 lines 28-32, when pressure increases, the pump flows liquid from the pump chamber out the outlet to the injection needle). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Schmid to include a micropump to pump insulin through the device to the injection site as taught by van Lintel in order to regulate the motion of liquid within the device (pg. 7 line 26 – pg. 8 line 4).
Schmid in view of van Lintel still does not disclose a pressure sensor separate from and in fluid communication with an outlet port of the micropump, the sensor comprising: a first wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports; a second wafer covering the fluid channel and including a pressure sensing mechanism; and a piezoelectric device layered on the second wafer and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure within channel.
However, Salman teaches a pressure sensor (FIG. 5, microflow sensor 10) separate from and in fluid communication with an outlet port of the micropump (col. 3 lines 60-66, "provides edge-to-edge flow" is interpreted by the examiner as having the ability to be connected to flow-providing elements), the sensor comprising: first wafer (FIG. 4, cap wafer 20) and second wafer (FIG. 3, base wafer 12) defining an inlet port (FIG. 4 and FIG. 5, col. 3 lines 60-66, the flat upper surface 14 of base wafer 12 covers the extending flow channel 26 of cap wafer 20, thereby clearly defining the fluid inlet to extending flow channel 26 defined by edge 28), and outlet port (FIG. 4, col. 3 lines 60-66, fluid outlet from extending flow channel 26 defined by edge 30) and fluid channel (FIG. 4, extending flow channel 26) communicating with the inlet and outlet ports (FIG. 4); the second wafer (FIG. 3, base wafer 12) including a pressure sensing mechanism (FIG. 3 and FIG. 5, examiner is interpreting pressure sensing element to mean both the flow sensing element 18 and the section of base wafer 12 cut out to configure flow sensing element 18 to work); and a piezoelectric device (flow sensing element 18) layered on the second wafer (FIG. 3 and FIG. 5) and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure from the insulin within channel (col. 4 lines 24-39, An input across the flow sensing element can be converted to an "electrical signal corresponding to a parameter of fluid flow". "The flow sensing element 18 can be any suitable type of flow sensing element", which could include a pressure sensing element). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Schmid to include a pressure sensor structured in a manner of having two wafers with a piezoelectric device layered on one of the wafer as taught by Salman in order that fluid flowing through the longitudinally extending flow channel passes across the sensing element (col. 2 lines 11-13).
Regarding claim 7, in the modified device of Schmid, Schmid does not disclose the wafer comprises the channel and an opening to the channel and the second wafer covers the opening in channel, thereby functioning as a wall to channel. However, Salman teaches the wafer comprises the channel and an opening to the channel (FIG. 4, extending flow channel 26 exist on cap wafer 20) and the second wafer covers the opening in channel (FIG. 4 and FIG. 5, col. 3 lines 60-66, fluid inlet to extending flow channel 26 defined by edge 28 and covered by base wafer 12), thereby functioning as a wall to channel (FIG. 5, the flat upper surface 14 of base wafer 12 covers the extending flow channel 26 of cap wafer 20, acting as a wall to the top of extending flow channel 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Schmid to have the wafers of a pressure sensor stacked on top of one another as taught by Salman in order that fluid flowing through the longitudinally extending flow channel passes across the sensing element (col. 2 lines 11-13).
Regarding claim 12, in the modified device of Schmid, Schmid does not disclose the piezoelectric device is a piezoelectric or piezoresistive transducer. However, Salman teaches the piezoelectric device is a piezoelectric or piezoresistive transducer (col. 4 lines 24-39, An input across the flow sensing element can be converted to an "electrical signal corresponding to a parameter of fluid flow". "The flow sensing element 18 can be any suitable type of flow sensing element", which could include a pressure sensing element). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Schmid to make the piezoelectric device a piezoelectric transducer as taught by Salman in order to create analyzable data from mechanical inputs turned into electrical signals (col. 4 lines 24-39).
Regarding claim 13, Schmid discloses a device for delivering medicament to a user (host fluid (medication) delivery device 100), the device comprising: a reservoir (reservoir 130) for storing the medicament ([0064], "a fluid reservoir 130 for holding a fluid"); a catheter (cannula 176) configured to deliver medicament to the user ([0066], cannula is "capable of passing the fluid into the host"); an introducer needle (needle 174) movable with respect to the catheter (FIG. 4 to FIG. 6, [0066], needle is retractable with respect to cannula), the introducer needle configured to facilitate (a) insertion of the catheter into the user ([0066], "the introducer needle/trocar 174 may initially penetrate the skin such that both the introducer needle/trocar 174 and the cannula 176 are introduced (inserted) into the host") and (b) removal of the introducer needle to enable delivery of medicament through the catheter ([0066] "the introducer needle/trocar 174 may then be retracted within the cannula 176").
Schmid does not disclose a micropump, in fluid communication with the reservoir and the catheter, for pumping the medicament from the reservoir through the catheter; and a pressure sensor separate from and in fluid communication with an outlet port of the micropump, the sensor comprising: a first wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports; a second wafer covering the fluid channel and including a pressure sensing mechanism; and a piezoelectric device layered on the second wafer and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure within channel.
However, van Lintel teaches a micropump (FIG. 3 and FIG. 4 entire embodiment is a micropump), in fluid communication with the reservoir and the catheter (FIG. 4, reservoir 24 connects to injection needle via conduit 21), for pumping the medicament from the reservoir through the catheter (pg. 7 lines 28-32, when pressure increases, the pump flows liquid from the pump chamber out the outlet to the injection needle). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Schmid to include a micropump to pump insulin through the device to the injection site as taught by van Lintel in order to regulate the motion of liquid within the device (pg. 7 line 26 – pg. 8 line 4).
Schmid in view of van Lintel still does not disclose a pressure sensor separate from and in fluid communication with an outlet port of the micropump, the sensor comprising: a first wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports; a second wafer covering the fluid channel and including a pressure sensing mechanism; and a piezoelectric device layered on the second wafer and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure within channel.
However, Salman teaches a pressure sensor (FIG. 5, microflow sensor 10) separate from and in fluid communication with an outlet port of the micropump (col. 3 lines 60-66, "provides edge-to-edge flow" is interpreted by the examiner as having the ability to be connected to flow-providing elements), the sensor comprising: a first wafer (FIG. 4, cap wafer 20) defining an inlet port (FIG. 4, col. 3 lines 60-66, fluid inlet to extending flow channel 26 defined by edge 28), and outlet port (FIG. 4, col. 3 lines 60-66, fluid outlet from extending flow channel 26 defined by edge 30) and fluid channel (FIG. 4, extending flow channel 26) communicating with the inlet and outlet ports (FIG. 4); a second wafer (FIG. 3, base wafer 12) covering the fluid channel (FIG. 5, the flat upper surface 14 of base wafer 12 covers the extending flow channel 26 of cap wafer 20) and including a pressure sensing mechanism (FIG. 3 and FIG. 5, examiner is interpreting pressure sensing element to mean both the flow sensing element 18 and the section of base wafer 12 cut out to configure flow sensing element 18 to work); and a piezoelectric device (flow sensing element 18) layered on the second wafer (FIG. 3 and FIG. 5) and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure within channel (col. 4 lines 24-39, An input across the flow sensing element can be converted to an "electrical signal corresponding to a parameter of fluid flow". "The flow sensing element 18 can be any suitable type of flow sensing element", which could include a pressure sensing element). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Schmid to include a pressure sensor structured in a manner of having two wafers with a piezoelectric device layered on one of the wafer as taught by Salman in order that fluid flowing through the longitudinally extending flow channel passes across the sensing element (col. 2 lines 11-13).
Regarding claim 18, Schmid discloses a device for delivering insulin to a user (host fluid (medication) delivery device 100), the device configured as a wearable apparatus or system (FIG. 44 displays delivery device 100 worn on a user) in which continuous glucose monitoring (CGM), insulin delivery and control functionality are provided to ensure insulin is delivered to the user ([0064]-[0065], device may also include integrated monitoring such as continuous glucose monitoring, device contains a fluid drive mechanism 150 for driving the fluid out of the reservoir 130, and device may include a circuit board 101 including a microcontroller), the device comprising: a reservoir (reservoir 130) for storing insulin ([0064], "a fluid reservoir 130 for holding a fluid"; [0062], fluid may be insulin); a catheter (cannula 176) configured to deliver insulin to a subcutaneous layer of the user ([0066], cannula is "capable of passing the fluid into the host").
Schmid does not disclose a micropump, in fluid communication with the reservoir and catheter, for pumping insulin from the reservoir through the catheter; and a pressure sensor separate from and in fluid communication with an outlet port of the micropump, the sensor comprising: first wafer and second wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports; the second wafer including a pressure sensing mechanism; and a piezoelectric device layered on the second wafer and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure from the insulin within channel.
However, van Lintel teaches a micropump (FIG. 3 and FIG. 4 entire embodiment is a micropump), in fluid communication with the reservoir and the catheter (FIG. 4, reservoir 24 connects to injection needle via conduit 21), for pumping insulin from the reservoir through the catheter (pg. 7 lines 28-32, when pressure increases, the pump flows liquid from the pump chamber out the outlet to the injection needle). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Schmid to include a micropump to pump insulin through the device to the injection site as taught by van Lintel in order to regulate the motion of liquid within the device (pg. 7 line 26 – pg. 8 line 4).
Schmid in view of van Lintel still does not disclose a pressure sensor separate from and in fluid communication with an outlet port of the micropump, the sensor comprising: a first wafer defining an inlet port, and outlet port and fluid channel communicating with the inlet and outlet ports; a second wafer covering the fluid channel and including a pressure sensing mechanism; and a piezoelectric device layered on the second wafer and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure within channel.
However, Salman teaches a pressure sensor (FIG. 5, microflow sensor 10) separate from and in fluid communication with an outlet port of the micropump (col. 3 lines 60-66, "provides edge-to-edge flow" is interpreted by the examiner as having the ability to be connected to flow-providing elements), the sensor comprising: first wafer (FIG. 4, cap wafer 20) and second wafer (FIG. 3, base wafer 12) defining an inlet port (FIG. 4 and FIG. 5, col. 3 lines 60-66, the flat upper surface 14 of base wafer 12 covers the extending flow channel 26 of cap wafer 20, thereby clearly defining the fluid inlet to extending flow channel 26 defined by edge 28), and outlet port (FIG. 4, col. 3 lines 60-66, fluid outlet from extending flow channel 26 defined by edge 30) and fluid channel (FIG. 4, extending flow channel 26) communicating with the inlet and outlet ports (FIG. 4); the second wafer (FIG. 3, base wafer 12) including a pressure sensing mechanism (FIG. 3 and FIG. 5, examiner is interpreting pressure sensing element to mean both the flow sensing element 18 and the section of base wafer 12 cut out to configure flow sensing element 18 to work); and a piezoelectric device (flow sensing element 18) layered on the second wafer (FIG. 3 and FIG. 5) and configured to generate a signal in response to the pressure sensing mechanism that is representative of pressure from the insulin within channel (col. 4 lines 24-39, An input across the flow sensing element can be converted to an "electrical signal corresponding to a parameter of fluid flow". "The flow sensing element 18 can be any suitable type of flow sensing element", which could include a pressure sensing element). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Schmid to include a pressure sensor structured in a manner of having two wafers with a piezoelectric device layered on one of the wafer as taught by Salman in order that fluid flowing through the longitudinally extending flow channel passes across the sensing element (col. 2 lines 11-13).
Regarding claim 19, in the modified device of Schmid, Schmid does not disclose the wafer comprises the channel and an opening to the channel and the second wafer covers the opening in channel, thereby functioning as a wall to channel. However, Salman teaches the wafer comprises the channel and an opening to the channel (FIG. 4, extending flow channel 26 exist on cap wafer 20) and the second wafer covers the opening in channel (FIG. 4 and FIG. 5, col. 3 lines 60-66, fluid inlet to extending flow channel 26 defined by edge 28 and covered by base wafer 12), thereby functioning as a wall to channel (FIG. 5, the flat upper surface 14 of base wafer 12 covers the extending flow channel 26 of cap wafer 20, acting as a wall to the top of extending flow channel 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Schmid to have the wafers of a pressure sensor stacked on top of one another as taught by Salman in order that fluid flowing through the longitudinally extending flow channel passes across the sensing element (col. 2 lines 11-13).
Regarding claim 24, in the modified device of Schmid, Schmid does not disclose the piezoelectric device is a piezoelectric or piezoresistive transducer. However, Salman teaches the piezoelectric device is a piezoelectric or piezoresistive transducer (col. 4 lines 24-39, An input across the flow sensing element can be converted to an "electrical signal corresponding to a parameter of fluid flow". "The flow sensing element 18 can be any suitable type of flow sensing element", which could include a pressure sensing element). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Schmid to make the piezoelectric device a piezoelectric transducer as taught by Salman in order to create analyzable data from mechanical inputs turned into electrical signals (col. 4 lines 24-39).
Claims 2-4, 8-10, 14-16, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid in view of van Lintel and Salman as applied to claims 1, 6, 13, and 18 above, and further in view of Stumpf et al. (WIPO International Publication No. WO 2020/154197 A1; herein, Stumpf).
Regarding claims 2, 8, 14 and 20, in the modified device of Schmid, Schmid does not disclose the channel includes a circular section. However, Stumpf teaches the channel includes a circular section (FIG. 3B, flow sensor 309 is a circular shape and fit within the middle section of the flow-meter body 317. The examiner interprets that since the circular-shaped sensor was placed within a cut-out section of the body, the cut-out section would also be circular.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid channel taught by Salman of the modified device disclosed by Schmid to include a circular section as taught by Stumpf in order that a circular shaped sensor be able to fit within the channel (FIG. 3A and 3B).
Regarding claims 3, 9, 15 and 21, in the modified device of Schmid, Schmid does not disclose the pressure sensing mechanism is a thin section of the second wafer that corresponds in location with the circular section, the thin section includes a wall, that functions as a membrane, that communicates with the fluid channel.
However, Salman teaches the pressure sensing mechanism is a thin section of the second wafer (FIG. 5, base wafer 12 is cut in a manner that leaves behind a thin section) and the thin section includes a wall, that functions as a membrane, that communicates with the fluid channel (FIG. 5, base wafer 12 is cut out, leaving behind walls to fit flow sensing element 18). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Schmid to make the pressure sensing mechanism a thin section of the second wafer including a wall that communicates with the fluid channel within the pressure sensor as taught by Salman in order that connection with the piezoelectric device be uninterrupted by structural components (col. 4 lines 4-23).
The modified Schmid still does not disclose a thin section of the second wafer that corresponds in location with the circular section. However, Stumpf teaches a thin section of the second wafer that corresponds in location with the circular section (FIG. 3B, flow sensor 309 is a circular shape and fit within the middle section of the flow-meter body 317. The examiner interprets that since the circular-shaped sensor was placed within a cut-out section of the body, the cut-out section would also be circular.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second wafer taught by Salman of the modified device disclosed by Schmid to correspond with a circular section as taught by Stumpf in order that a circular shaped sensor be able to fit within the channel (FIG. 3A and 3B).
Regarding claims 4, 10, 16, and 22, in the modified device of Schmid, Schmid does not disclose the piezoelectric device is layered over the thin section. However, Salman teaches the piezoelectric device is layered over the thin section (FIG. 5, base wafer 12 is cut out, leaving a thin section to fit flow sensing element 18). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Schmid to layer the piezoelectric device over the thin section as taught by Salman in order that connection with the piezoelectric device be uninterrupted by structural components (col. 4 lines 4-23).
Claims 5, 11, 17, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid in view of van Lintel and Salman as applied to claims 1, 6, 13, and 18 above, and further in view of Pepin (United States Patent Application Publication No. US 2008/0097296 A1).
Regarding claims 5, 11, 17, and 23, in the modified device of Schmid, Schmid does not disclose first wafer includes indentations in the fluid channel to facilitate press fitting of tubing. However, Pepin teaches first wafer includes indentations in the fluid channel (Figure 2, compression members 38) to facilitate press fitting of tubing ([0044], compression member 38 “may be configured to engage and compress against the outer surface of the shaft”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first wafer taught by Salman of the modified device disclosed by Schmid to include indentations in the fluid channel as taught by Pepin in order to provide for better connection and/or a fluid tight seal ([0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sander (United States Patent No. US 7,217,395 B2) is considered relevant prior art with regards to piezoelectrically controllable microfluid actor system with two interconnected diaphragm layers.
Bazargan et al. (United States Patent No. US 8,628,510 B2) is considered relevant prior art with regards to a device for delivering fluid.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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