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 statements (IDS) submitted on 07/29/2024, 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.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference signs mentioned in the description: micropump 100 and cavity 102.
The drawings are objected to because in FIG. 3, the drawings portray the reference signs “r1” and “r2”. However, the specification lacks description of what “r1” and “r2” represent. “r1” and “r2” can be found in equations within paragraphs [0018], [0019], and [0020], yet none providing a definition for what either of the reference signs are. The examiner suggests modifying the specification to disclose what “r1” and “r2” are meant to represent.
The drawings are objected to because in FIG. 1, a few parts of the drawings have been labeled as bonding pads 119. However, in identical parts of the drawing, there appears to be missing a label for more bonding pads (see annotated FIG. 1 below). The examiner suggests correcting the drawing to label all parts of the drawing to give a more comprehensive view of the invention.
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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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 [0013], the specification states “(However, various types of MEMS sensors can be used as the sensing elements of the architecture.) Further, other MEMS or non-MEMS structures or technology may also be used to achieve desired results as known to those skilled in the art.)”. There is an incomplete parentheses error. The examiner suggest correcting the sentence to be “(However, various types of MEMS sensors can be used as the sensing elements of the architecture. Further, other MEMS or non-MEMS structures or technology may also be used to achieve desired results as known to those skilled in the art.)” to keep all the information regarding alternative uses for the MEMS devices together.
In paragraph [0014], the specification states “The handle silicon layer of the SOI wafer is removed to form the pump membrane.” Using the article “the” implies there has been a previous recital of “handle”. However, “handle” is only mentioned within paragraph [0014]. It is unclear to the examiner what the applicant is referencing here, as well as what point they are attempting to convey. The examiner suggest modifying the specification and/or drawings to better explain the meaning of this sentence.
In paragraph [0016], the specification begins to reference wafer 106 as “the second wafer 106”. There is a lack of continuity in this recitation as there has been no previous reference to a numbering of the wafers 104, 106. If the applicant would like the wafers to be numbered as first and second, the examiner suggests initializing the naming convention upon first reference of the individual wafer (as the applicant did in paragraph [0014] by saying “wafer 104 (top wafer)”).
In paragraphs [0016], [0017], and [0018], the specification references “valve sections 122,124”. However, “valve sections” have been previously referenced in the specification using reference number 126, 128, as well as use reference numbers 126, 128 in the drawings. The examiner suggests correcting “valve sections 122,124” to “valve sections 126,128” for continuity purposes.
In paragraph [0023], the specification states “Fig. 4 depicts a block diagram of example components of device 400 for delivering insulin of an infusion system as described above. (Device 104 is renumbered as device 400 in Fig. 4.) Specifically, device 400…”. There is a punctuation error present. The examiner suggest correcting the specification to state “Fig. 4 depicts a block diagram of example components of device 400 for delivering insulin of an infusion system as described above. (Device 104 is renumbered as device 400 in Fig. 4.). Specifically, device 400…” to maintain proper grammar.
In paragraph [0023], the specification states “Device 400 also includes microcontroller unit (MCU) 400-4 and battery and power controller 400-5.” The reference numbers for the MCU and battery/power controller have been incorrectly swapped, according to FIG. 4. The examiner suggest modifying the specification to state “Device 400 also includes microcontroller unit (MCU) 400-5 and battery and power controller 400-4.” to maintain continuity with the drawings.
In paragraph [0024], the specification states “MCU 400-4”. However, according to FIG. 4, the microcontroller unit is identified by the reference number 400-4, as well as future reference in later paragraphs. The examiner suggests correcting “MCU 400-4” to “MCU 400-5” for continuity purposes.
Appropriate correction is required.
Claim Objections
Claims 1, 6, and 12 are objected to because of the following informalities: Each structural feature should be preceded by an article, but the phrase “first and second wafers” in line 6 (claim 1, 6) and line 4 (claim 12) lacks an article preceding it. The examiner suggests modifying the phrase to read as “a first wafer and a second wafer”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: In the fifteenth line of the claim, the applicant refers to “the valve section”. However previously, the applicant referred to “a first valve section”. To maintain consistency, the examiner suggests modifying “the valve section” to “the first valve section”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: In the ninth line of the claim, the claim states “the first wafer configured as a membrane that that is adapted to…”. The examiner suggests modifying the claim to remove a “that”, so the claim reads as “the first wafer configured as a membrane that is adapted to…”. Further, in the eighteenth line of the claim, the claim states “and (2) a valve gap”. There is no previous reference to a “(1)” in the same claim, and therefore makes the recitation of “(2)” unnecessary. The examiner suggests modifying the claim to read as “and a valve gap”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: In the third line of the claim, the claim references “a second valve section”. It is unclear to the examiner is this valve section is the same as that previously mentioned in claim 6 as “the second valve section” (see 112(b) antecedent basis rejection below). Based on context clues within claims 6 and 9, the examiner will interpret “a second valve section” to be a separate valve section from “the second valve section” (see 112(b) rejection below; examiner interprets to be the same as “a first valve section” within claim 6). Further, in the fifth line of the claim, the claim states “and (2) a second valve gap”. There is no previous reference to a “(1)” in the same claim, and therefore makes the recitation of “(2)” unnecessary. The examiner suggests modifying the claim to read as “and a valve gap”. Appropriate correction is required.
Applicant is advised that should claim 6 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2, 3, 7, 8, 13, and 14 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention. The claims describe a valve seat as having a width and a radius “that is adjusted to increase the hydraulic resistance” in a valve gap. At the time of the effective filing date, the specification did not provide support for how the width and/or radius of the valve seat could be adjusted in order to increase the hydraulic resistance. The only support found in the specification is found in paragraph [0020], where the applicant states “By changing the dimensions of this valve seat (given the viscosity of fluid in this example), the hydraulic resistance through the valve gap dominates that of the valve chamber and the rest of micropump 100 by orders of magnitude and is therefore of importance (and for calculations).” and “By varying the valve gap distance, the hydraulic resistance of the valve may be tuned further, i.e., increasing the width would further increase the hydraulic resistance, and vice versa. Finally, the radius of the valve seat may also be adjusted which when increased results as follows: 1) it reduces hydraulic resistance as the area in which the fluid flows is increased but 2) means that the gap height between the valve seat (lip) and the membrane decreases as the deflection or deformation of a circular silicon membrane is parabolic from the center (and vice versa).” Although the specification mentions a change in the dimensions and an adjustment of the valve seat radius may occur, the specification lacks written description as how this modification occurs, as well as how it does impact the hydraulic resistance. It is confusing to the examiner if the adjustments occur during use of the device, or at a separate time, and further if the device automatically adjusts the valve seat, or if the adjustment needs to be completed manually. Without inclusion of these details, the examiner is not convinced the applicant had possession of the claimed invention at the time of filing. For the purposes of examination, the examiner will interpret the claims to mean the size of the orifice of the valve seat can change depending on if fluid is being moved through the valve seat or not.
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 1-3, 6-10, and 12-14 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 2 recites the limitation "the valve seat" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the valve seat" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the second valve section" in the twenty-third line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the second valve gap" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the second valve gap" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the second valve section" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the second chamber" in the tenth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the valve seat" in the fi. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the valve seat" in the . There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the valve seat" in the . There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 1-3, 6-10, 12-14, the language of the claims renders it unclear as to what recited elements are being referred to under the use of numeric language. Mainly, within the independent claims 1, 6, and 12, the applicant fluctuates between numeric language such as “a first valve section”, “a first port”, “a second piezoelectric actuator”, “a second chamber”. Although using numeric language is not inherent wrong, the manner in which it is used here renders the claims unclear, as the examiner is unsure what parts of the device the applicant is referring to. The elements of the claims were not numbered in the specification, and are given separate reference numbers in the drawings. For example, claim 9 states “a first valve seat around the second port”. The valve seat could be either valve seat 130 or 132, as well as the second port could be inlet port 114 or outlet port 116. Leaving the claims open to such interpretation renders the claims indefinite. The examiner suggest adding numeric language within the specification, or reviewing the claims to make sure the numeric language used at least is in line with the drawings, as there were fluctuations in numbering that occurred which did not align with the disclosure. For the purposes of examination, the examiner attempted to understand the numbering in light of the drawings and specification.
Regarding claim 1, the language of claim 1 renders it unclear as to what recited elements constitute the “MEMS device”. Specifically, the language renders it unclear as to: whether the device includes a “valve” or if the entire device as a whole is intended to be a valve. In the specification, the device is described as a “micropump” as well as FIG. 1 depicts the device as incorporating a valve, so it is confusing to the examiner the intention of the applicant in describing the device as a “valve”. The examiner suggest modifying the language of claim 1 to clarify if the entire device is a valve or if the device includes a valve. For the purposes of examination, the examiner will interpret the claim to mean the device includes a valve.
Regarding claims 1 and 6, the language of claims renders it indefinite when stating “a hydraulic resistance through the valve gap exceeds a hydraulic resistance in the valve section”. The valve gap has been previously stated as part of the valve section, so the claim begins to lack clarity when the comparison is drawn as to how the hydraulic resistance of a part of the section could exceed the hydraulic resistance of the section as a whole. There is not enough support in the claims, nor the specification, to understand how this limitation is to work properly. The examiner suggest modifying the claims to add specificity to the limitation. For the purposes of examination, the examiner will interpret the claims to mean a hydraulic resistance within the valve gap exceeds a hydraulic resistance in the cavity chamber, excluding the valve gap.
Regarding claims 2, 3, 7, 8, 13, and 14, the language of the claims renders it unclear as to how the width and radius of the valve seat “is adjusted to increase the hydraulic resistance” in the valve gap. The claims lacks explanation for the adjustment mechanism, whether that be manual or automatic, and one having ordinary skill in the art would not be able to assert how to adjust the width and radius of the valve seat by the claims, and further by the specification (see 112(a) rejection above). The examiner suggest modifying the claims to add specificity to the manner in which the adjustment occurs in order to remove any indefiniteness. For the purposes of examination, the examiner will interpret the claims to mean the size of the orifice of the valve seat can change depending on if fluid is being moved through the valve seat or not.
Regarding claim 6, the language of claim 6 renders it unclear as to what valve sections contain which elements. Claim 6 mentions both “a first valve section” and “the second valve section” (see 112(b) antecedent basis rejection above). However, the elements that follow the recitation of “the second valve section” would correlate better being apart of “a first valve section”, as mention is made to “the first valve seat” and “the second port”, both elements recited as being included by “a first valve section”. By that understanding, the claim is rendered indefinite and lacks clarity. The examiner suggests modifying “the second valve section” to be “the first valve section” to better clarify the claim limitations.
Regarding claim 9, the language of claim 9 renders it unclear as to which valve seat is around the second port. Claim 9 states “a second valve seat around the second port”, however claim 6, upon which claim 9 is dependent, states “a first valve seat around the second port”. It is unclear to the examiner which valve seat is supposed to be around the second port, and therefore renders the claim indefinite. The examiner suggest modifying claim 9 to remove overlapping limitations. For the purposes of examination, the examiner will interpret claim 9 to include “a second valve seat around the first port”.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fouillet et al. (United States Patent Application Publication No. US 2014/0044568 A1; herein, Fouillet), and further in view of Paul (United States Patent Application Publication No. US 2006/0200112 A1) and Ueda et al. (United States Patent Application Publication No. US 2013/0237923 A1; herein, Ueda).
Regarding claim 1, Fouillet discloses a MEMS device (FIG. 8, micropump), the MEMS device configured as a valve for permitting or preventing a flow of the medicament to the user (micropump contains a valve section (Annotated on FIG. 8 below) by which a piezoelectric platelet controls a deformable membrane which would in turn control the movement of medicament ([0155])), the MEMS device comprising:
a first port (FIG. 8, inlet 51) and a second port (FIG. 8, outlet 52) to enable medicament to flow through the MEMS device ([0147], "clearances will ensure fluidic communication between the inlet 51 and the outlet 52 conduits and the cavities 9, 17 into which they open");
first (FIG. 8, second substrate 30) and second wafers (FIG. 8, first substrate 20) that define a cavity therebetween that communicates with the first and second ports, thereby creating a fluid path for a flow of the medicament from the first port to the second port (FIG. 8 and FIG. 9, [0141]-[0142], cavities 9, 11, 13, 15, 17 and communication channels 10, 12, 14, 16 make up a fluid cavity between the inlet 51 and outlet 52), the first wafer configured as a membrane adapted to deform ([0152], [0156], second substrate 30 contains membrane portion which are deformable of cavities 9, 15, and 17), the cavity including a first chamber that communicates with the second port (FIG. 8, cavity (or chamber) 17);
a first valve section (Annotated on FIG. 8 below) including (1) a first valve seat around the first port that extends from the second wafer into the first chamber to a distal end thereof (FIG. 8 and FIG. 9, [0144], annular lip 56') and (2) a valve gap that is defined as a distance between the distal end and the membrane (FIG. 8, [0145]-[0147], clearance 61 give the possibility of guaranteeing that the apex of the lip 56’ does not touch the lower face of the second substrate 30), wherein the valve seat is configured so that a hydraulic resistance through the valve gap exceeds a hydraulic resistance in the valve section in the event the MEMS device has lost power ([0142], [0145], [0152], [0155], Power to device controlled by connection between electric wire 84 and piezoelectric platelets 81. Second substrate 30 and membranes of cavities 9,15,17 are able to deform as a result of power. If no power exist, the substate 30 and membranes cannot deform. However, the clearance 61 only has a small depth of a few microns above annular lip 56’ as opposed to other communication channels 10, 14, 16 which have a larger width of a few hundred microns. Therefore, in an event of no deformation to restrict fluid passage, the hydraulic resistance of the clearance 61/annular lip 56’ gap would still exceed that of the other channels in the same section strictly based on size.); and
a first piezoelectric actuator (Annotated on FIG. 8 below, piezoelectric means in the form of platelet 81) layered on the first wafer (FIG. 8, [0152], "platelets 81, positioned on the upper face of the second substrate 30") and configured to cause the membrane to deform and close off the first valve seat, thereby preventing fluid flow through the first port ([0155], " Thus, an electric voltage may be applied, independently, to each piezoelectric platelet. The deformation of a piezoelectric platelet then causes deformation of the corresponding deformable membrane. The piezoelectric platelets may therefore be used as a means for actuating the membranes in order to deform the latter." Deformation of the substrate 30 and membranes would cut off the supply of fluid going through outlet 52.).
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Fouillet does not explicitly disclose the MEMS device for a device for delivering medicament to a user, and ensuring that medicament is prevented from flowing through the first port.
However, Paul teaches the MEMS device for a device for delivering medicament to a user (FIG. 1 and FIG. 2, insulin pump 100 utilizes MEMS pump 208). 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 MEMS device disclosed by Fouillet to be incorporated into a device for delivering medicament to a user as taught by Paul in order to automatically draw insulin from a reservoir for the purpose of dispensing this insulin to the patient ([0043]).
Fouillet in view of Paul still does not explicitly disclose ensuring that medicament is prevented from flowing through the first port. However, Ueda teaches ensuring that medicament is prevented from flowing through the first port (FIG. 1, [0053], The pipe connecting port 6 is blocked by the valve 3 when no pressing force is applied. No connection to flow patch can happen at this time.). 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 MEMS device disclosed by Fouillet to explicitly disclose liquid is prevented from flowing through a valve as taught by Ueda in order to control fluid access through the device during times when the device is not fully operational ([0053]).
Regarding claim 2, in the modified device of Fouillet, Fouillet does not disclose the valve seat has a width that is adjusted to increase the hydraulic resistance in the valve gap. However, Ueda teaches the valve seat has a width that is adjusted to increase the hydraulic resistance in the valve gap (FIG. 4A and FIG. 4C, The width of the deformable portion 31 increases or decreases depending on if a pressing force is applied. One having ordinary skill would understand that changing the width of the deformable portion correlates with hydraulic resistance as liquid would be more or less inclined to moved depending on the amount of space given to flow.). 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 MEMS device disclosed by Fouillet to adjust the width of the valve seat as taught by Ueda in order the top surface of the valve forms the opening to a specific diameter which communicates with the flow path ([0063]).
Regarding claim 3, in the modified device of Fouillet, Fouillet does not disclose the valve seat has a radius that is adjusted to increase the hydraulic resistance in the valve gap. However, Ueda teaches the valve seat has a radius that is adjusted to increase the hydraulic resistance in the valve gap (FIG. 4A and FIG. 4C, The radius of the deformable portion 31 opening increases or decreases depending on if a pressing force is applied. One having ordinary skill would understand that changing the radius of the deformable portion opening correlates with hydraulic resistance as liquid would be more or less inclined to moved depending on the amount of space given to flow.). 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 MEMS device disclosed by Fouillet to adjust the radius of the valve seat as taught by Ueda in order the top surface of the valve forms the opening to a specific diameter which communicates with the flow path ([0063]).
Regarding claim 4, in the modified device of Fouillet, Fouillet discloses the cavity includes a second chamber in communication with the first chamber and first port (FIG. 8 and FIG. 9, central cavity 15) and the MEMS device further comprising a pump section (Annotated on FIG. 8 below) including a second piezoelectric actuator (Annotated on FIG. 8 below, piezoelectric means in the form of platelet 81) that is layered on top of the first wafer (FIG. 8, [0152], "platelets 81, positioned on the upper face of the second substrate 30, and positioned on the deformable membranes of the cavities 9, 15, 17.") and is configured to deform the first wafer into the second chamber to draw into or displace medicament into the cavity ([0155], " Thus, an electric voltage may be applied, independently, to each piezoelectric platelet. The deformation of a piezoelectric platelet then causes deformation of the corresponding deformable membrane. The piezoelectric platelets may therefore be used as a means for actuating the membranes in order to deform the latter.").
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Regarding claim 5, in the modified device of Fouillet, Fouillet does not explicitly disclose the medicament is insulin. However, Paul teaches the medicament is insulin (insulin infusion pump 100, [0040] insulin flows through device). 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 MEMS device disclosed by Fouillet to specify the fluid as insulin as taught by Paul in order to make the device specific to one medicament ([0003]).
Regarding claim 6, Fouillet discloses a MEMS device (FIG. 8, micropump) configured as a micropump for pumping the medicament into the user (micropump contains a pump section (Annotated on FIG. 8 below) by which a piezoelectric platelet controls a deformable membrane which would in turn control the movement of medicament ([0155])), the MEMS device comprising:
a first port (FIG. 8, inlet 51) and a second port (FIG. 8, outlet 52) to enable medicament to flow through the MEMS device ([0147], "clearances will ensure fluidic communication between the inlet 51 and the outlet 52 conduits and the cavities 9, 17 into which they open");
first (FIG. 8, second substrate 30) and second wafers (FIG. 8, first substrate 20) that define a cavity therebetween that communicates with the first and second ports, thereby creating a fluid path for a flow of the medicament from the first port to the second port (FIG. 8 and FIG. 9, [0141]-[0142], cavities 9, 11, 13, 15, 17 and communication channels 10, 12, 14, 16 make up a fluid cavity between the inlet 51 and outlet 52), the first wafer configured as a membrane that that is adapted to deform into the cavity ([0152], [0156], second substrate 30 contains membrane portion which are deformable of cavities 9, 15, and 17), the cavity including a first chamber that communicates with the first port (FIG. 8 and FIG. 9, central cavity 15) and a second chamber that communicates with the first chamber and the second port creating the fluid path and enabling the flow of medicament through the MEMS device (FIG. 8, cavity (or chamber) 17);
a pump section (Annotated on FIG. 8 below) including a first piezoelectric actuator (Annotated on FIG. 8 below, piezoelectric means in the form of platelet 81) that is layered on top of the first wafer (FIG. 8, [0152], "platelets 81, positioned on the upper face of the second substrate 30, and positioned on the deformable membranes of the cavities 9, 15, 17.") and is configured to deform the first wafer into the first chamber to draw into or displace medicament into the first chamber ([0155], " Thus, an electric voltage may be applied, independently, to each piezoelectric platelet. The deformation of a piezoelectric platelet then causes deformation of the corresponding deformable membrane. The piezoelectric platelets may therefore be used as a means for actuating the membranes in order to deform the latter." One having ordinary skill in the art would understand during deformation within a specific cavity, medicament would be moved.); and
a first valve section (Annotated on FIG. 8 below) including a first valve seat around the second port that extends from the second wafer into the second chamber to a distal end thereof (FIG. 8 and FIG. 9, [0144], annular lip 56') and (2) a valve gap that is defined as a distance between the distal end and the membrane (FIG. 8, [0145]-[0147], clearance 61 give the possibility of guaranteeing that the apex of the lip 56' does not touch the lower face of the second substrate 30), wherein the valve seat is configured so that a hydraulic resistance through the valve gap exceeds a hydraulic resistance in the valve section in the event the MEMS device has lost power ([0142], [0145], [0152], [0155], Power to device controlled by connection between electric wire 84 and piezoelectric platelets 81. Second substrate 30 and membranes of cavities 9,15,17 are able to deform as a result of power. If no power exist, the substate 30 and membranes cannot deform. However, the clearance 61 only has a small depth of a few microns above annular lip 56’ as opposed to other communication channels 10, 14, 16 which have a larger width of a few hundred microns. Therefore, in an event of no deformation to restrict fluid passage, the hydraulic resistance of the clearance 61/annular lip 56’ gap would still exceed that of the other channels in the same section strictly based on size.),
wherein the second valve section (Annotated on FIG. 8 below as “first valve section” (see 112(b) rejection above regarding difference between first and section valve sections)) further includes a second piezoelectric actuator (Annotated on FIG. 8 below, piezoelectric means in the form of platelet 81) layered on the first wafer (FIG. 8, [0152], "platelets 81, positioned on the upper face of the second substrate 30") and configured to cause the membrane to deform and close off the first valve seat, thereby preventing fluid flow through the second port ([0155], " Thus, an electric voltage may be applied, independently, to each piezoelectric platelet. The deformation of a piezoelectric platelet then causes deformation of the corresponding deformable membrane. The piezoelectric platelets may therefore be used as a means for actuating the membranes in order to deform the latter.").
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Fouillet does not disclose a device for delivering medicament to a user including the MEMS device, and ensuring that medicament is prevented from flowing through the second port.
However, Paul teaches a device for delivering medicament to a user including the MEMS device (FIG. 1 and FIG. 2, insulin pump 100 utilizes MEMS pump 208). 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 MEMS device disclosed by Fouillet to be incorporated into a device for delivering medicament to a user as taught by Paul in order to automatically draw insulin from a reservoir for the purpose of dispensing this insulin to the patient ([0043]).
Fouillet in view of Paul still does not explicitly disclose ensuring that medicament is prevented from flowing through the second port. However, Ueda teaches ensuring that medicament is prevented from flowing through the second port (FIG. 1, [0053], The pipe connecting port 6 is blocked by the valve 3 when no pressing force is applied. No connection to flow patch can happen at this time.). 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 MEMS device disclosed by Fouillet to explicitly disclose liquid is prevented from flowing through a valve as taught by Ueda in order to control fluid access through the device during times when the device is not fully operational ([0053]).
Regarding claim 7, in the modified device of Fouillet, Fouillet does not disclose the first valve seat has a width that is adjusted to increase the hydraulic resistance through the second valve gap. However, Ueda teaches the first valve seat has a width that is adjusted to increase the hydraulic resistance through the second valve gap (FIG. 4A and FIG. 4C, The width of the deformable portion 31 increases or decreases depending on if a pressing force is applied. One having ordinary skill would understand that changing the width of the deformable portion correlates with hydraulic resistance as liquid would be more or less inclined to moved depending on the amount of space given to flow.). 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 MEMS device disclosed by Fouillet to adjust the width of the valve seat as taught by Ueda in order the top surface of the valve forms the opening to a specific diameter which communicates with the flow path ([0063]).
Regarding claim 8, in the modified device of Fouillet, Fouillet does not disclose the first valve seat has a radius that is adjusted to increase the hydraulic resistance through the second valve gap. However, Ueda teaches the first valve seat has a radius that is adjusted to increase the hydraulic resistance through the second valve gap (FIG. 4A and FIG. 4C, The radius of the deformable portion 31 opening increases or decreases depending on if a pressing force is applied. One having ordinary skill would understand that changing the radius of the deformable portion opening correlates with hydraulic resistance as liquid would be more or less inclined to moved depending on the amount of space given to flow.). 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 MEMS device disclosed by Fouillet to adjust the radius of the valve seat as taught by Ueda in order the top surface of the valve forms the opening to a specific diameter which communicates with the flow path ([0063]).
Regarding claim 9, in the modified device of Fouillet, Fouillet discloses the cavity includes a third chamber in communication with the first chamber and first port (FIG. 8, cavity (or chamber) 9) and the MEMS device further comprising a second valve section (Annotated on FIG. 8 below) including a second valve seat around the second port that extends from the second wafer into the third chamber to a distal end thereof (FIG. 8 and FIG. 9, [0144], annular lip 56) and (2) a second valve gap that is defined as a distance between the distal end and the membrane (FIG. 8, [0145]-[0147], clearance 61 give the possibility of guaranteeing that the apex of the lip 56 does not touch the lower face of the second substrate 30), wherein the valve seat is configured so that a hydraulic resistance through the second valve gap exceeds a hydraulic resistance in the second valve section in the event the MEMS device has lost power ([0142], [0145], [0152], [0155], Power to device controlled by connection between electric wire 84 and piezoelectric platelets 81. Second substrate 30 and membranes of cavities 9,15,17 are able to deform as a result of power. If no power exist, the substate 30 and membranes cannot deform. However, the clearance 61 only has a small depth of a few microns above annular lip 56’ as opposed to other communication channels 10, 14, 16 which have a larger width of a few hundred microns. Therefore, in an event of no deformation to restrict fluid passage, the hydraulic resistance of the clearance 61/annular lip 56’ gap would still exceed that of the other channels in the same section strictly based on size.).
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Fouillet does not disclose ensuring that medicament is prevented from flowing through the second port. However, Ueda teaches ensuring that medicament is prevented from flowing through the second port (FIG. 1, [0053], The pipe connecting port 6 is blocked by the valve 3 when no pressing force is applied. No connection to flow patch can happen at this time.). 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 MEMS device disclosed by Fouillet to explicitly disclose liquid is prevented from flowing through a valve as taught by Ueda in order to control fluid access through the device during times when the device is not fully operational ([0053]).
Regarding claim 10, in the modified device of Fouillet, Fouillet discloses the second valve section further includes a second piezoelectric actuator (Annotated on FIG. 8 below, piezoelectric means in the form of platelet 81) layered on the first wafer (FIG. 8, [0152], "platelets 81, positioned on the upper face of the second substrate 30") and configured to cause the membrane to deform and close off the second valve seat, thereby preventing fluid flow through the second port ([0155], " Thus, an electric voltage may be applied, independently, to each piezoelectric platelet. The deformation of a piezoelectric platelet then causes deformation of the corresponding deformable membrane. The piezoelectric platelets may therefore be used as a means for actuating the membranes in order to deform the latter.").
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Regarding claim 11, in the modified device of Fouillet, Fouillet does not explicitly disclose the medicament is insulin. However, Paul teaches the medicament is insulin (insulin infusion pump 100, [0040] insulin flows through device). 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 MEMS device disclosed by Fouillet to specify the fluid as insulin as taught by Paul in order to make the device specific to one medicament ([0003]).
Regarding claim 12, Fouillet discloses a method of actuating a MEMS device (FIG. 8, micropump; [0155], Power to device controlled by connection between electric wire 84 and piezoelectric platelets 81.), the MEMS device configured as a valve for permitting or preventing a flow of the medicament to the user (micropump contains a valve section (Annotated on FIG. 8 below) by which a piezoelectric platelet controls a deformable membrane which would in turn control the movement of medicament ([0155])), the MEMS device including a first port (FIG. 8, inlet 51) and a second port (FIG. 8, outlet 52) to enable medicament to flow through the MEMS device ([0147], "clearances will ensure fluidic communication between the inlet 51 and the outlet 52 conduits and the cavities 9,17 into which they open"), first (FIG. 8, second substrate 30) and second wafers (FIG. 8, first substrate 20) that define a cavity therebetween that communicates with the first and second ports, thereby creating a fluid path for a flow of the medicament from the first port to the second port (FIG. 8 and FIG. 9, [0141]-[0142], cavities 9, 11, 13, 15, 17 and communication channels 10, 12, 14, 16 make up a fluid cavity between the inlet 51 and outlet 52), the first wafer configured as a membrane ([0152], [0156], second substrate 30 contains membrane portion which are deformable of cavities 9, 15, and 17), the cavity including a first chamber that communicates with the second port (FIG. 8, cavity (or chamber) 17), the MEMS device further including (1) a first valve section (Annotated on FIG. 8 below) with a first valve seat around the second port that extends from the second wafer into the second chamber to a distal end thereof (FIG. 8 and FIG. 9, [0144], annular lip 56'), (2) a valve gap that is defined as a distance between the distal end and the membrane (FIG. 8, [0145]-[0147], clearance 61 give the possibility of guaranteeing that the apex of the lip 56' does not touch the lower face of the second substrate 30) and (3) a first piezoelectric actuator (Annotated on FIG. 8 below, piezoelectric means in the form of platelet 81) layered on the first wafer (FIG. 8, [0152], "platelets 81, positioned on the upper face of the second substrate 30") to cause the membrane to deform and seal the second port, thereby preventing fluid flow through the second port ([0155], " Thus, an electric voltage may be applied, independently, to each piezoelectric platelet. The deformation of a piezoelectric platelet then causes deformation of the corresponding deformable membrane. The piezoelectric platelets may therefore be used as a means for actuating the membranes in order to deform the latter."). and a hydraulic resistance through the valve gap exceeds a hydraulic resistance in the MEMS device in the event the MEMS device has lost power ([0142], [0145], [0152], [0155], Power to device controlled by connection between electric wire 84 and piezoelectric platelets 81. Second substrate 30 and membranes of cavities 9,15,17 are able to deform as a result of power. If no power exist, the substate 30 and membranes cannot deform. However, the clearance 61 only has a small depth of a few microns above annular lip 56’ as opposed to other communication channels 10, 14, 16 which have a larger width of a few hundred microns. Therefore, in an event of no deformation to restrict fluid passage, the hydraulic resistance of the clearance 61/annular lip 56’ gap would still exceed that of the other channels in the same section strictly based on size.).
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Fouillet does not disclose the MEMS device for a device for delivering medicament to a user, and the method comprising: adjusting the dimensions of the valve seat so that to ensure that medicament is prevented from flowing through the second port.
However, Paul teaches the MEMS device for a device for delivering medicament to a user (FIG. 1 and FIG. 2, insulin pump 100 utilizes MEMS pump 208). 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 MEMS device disclosed by Fouillet to be incorporated into a device for delivering medicament to a user as taught by Paul in order to automatically draw insulin from a reservoir for the purpose of dispensing this insulin to the patient ([0043]).
Fouillet in view of Paul still does not explicitly disclose the method comprising: adjusting the dimensions of the valve seat so that to ensure that medicament is prevented from flowing through the second port. However, Ueda teaches adjusting the dimensions of the valve seat (FIG. 4A and FIG. 4C, The width of the deformable portion 31 increases or decreases depending on if a pressing force is applied. One having ordinary skill would understand that changing the width of the deformable portion correlates with hydraulic resistance as liquid would be more or less inclined to moved depending on the amount of space given to flow.) so that to ensure that medicament is prevented from flowing through the second port (FIG. 1, [0053], The pipe connecting port 6 is blocked by the valve 3 when no pressing force is applied. No connection to flow patch can happen at this time.). 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 MEMS device disclosed by Fouillet to explicitly disclose adjusting the dimensions of the valve seat to prevent liquid from flowing through a valve as taught by Ueda in order to control fluid access through the device during times when the device is not fully operational ([0053]).
Regarding claim 13, in the modified device of Fouillet, Fouillet does not disclose adjusting a width of the valve seat to increase the hydraulic resistance in the valve gap. However, Ueda teaches adjusting a width of the valve seat to increase the hydraulic resistance in the valve gap (FIG. 4A and FIG. 4C, The width of the deformable portion 31 increases or decreases depending on if a pressing force is applied. One having ordinary skill would understand that changing the width of the deformable portion correlates with hydraulic resistance as liquid would be more or less inclined to moved depending on the amount of space given to flow.). 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 MEMS device disclosed by Fouillet to adjust the width of the valve seat as taught by Ueda in order the top surface of the valve forms the opening to a specific diameter which communicates with the flow path ([0063]).
Regarding claim 14, in the modified device of Fouillet, Fouillet does not disclose adjusting a radius of the valve seat to increase the hydraulic resistance in the valve gap. However, Ueda teaches adjusting a radius of the valve seat to increase the hydraulic resistance in the valve gap (FIG. 4A and FIG. 4C, The radius of the deformable portion 31 opening increases or decreases depending on if a pressing force is applied. One having ordinary skill would understand that changing the radius of the deformable portion opening correlates with hydraulic resistance as liquid would be more or less inclined to moved depending on the amount of space given to flow.). 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 MEMS device disclosed by Fouillet to adjust the radius of the valve seat as taught by Ueda in order the top surface of the valve forms the opening to a specific diameter which communicates with the flow path ([0063]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Van Lintel (United States Patent No. 5,759,014 A) is considered relevant prior art with regards to a micropump having inlet and outlet valves connected by multiple chambers and a piezoelectric element.
Sander (United States Patent No. 7,217,395 B2) is considered relevant prior art with regards to piezoelectrically controllable microfluid system with two layers and ports.
Kang et al. (United States Patent No. 9,103,336 B2) is considered relevant prior art with regards to a dual wafer micropump for pumping fluid through an inlet section to an outlet section.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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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