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 .
Specification
The disclosure is objected to because of the following informalities: Figures 9 a/b are mistakenly referred to as figures 7 a/b in the specification – pg 10, “Hence, the liquid to be sampled will be transported to an entrance 148 of the microfluidic valve 136 (see figure 7a) but cannot overcome the microfluidic valve due to an increase in width at the entrance to a valve chamber 150 of the microfluidic valve; see figure 7b.”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“injection means” in claim 2 – pg 11, “For injecting the air bubble, an air chamber 154 is provided that can be manually com- pressed by a user.”
“a test unit” in claim 3 – spec pg 7, lines 2-3 “a testing unit that may comprise the testing strip 114 or other testing means for instance electronic testing means comprising sensors or the like.”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 8 is 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.
The term “about” in claim 8 is a relative term which renders the claim indefinite. The term “about 80 μm to 160 μm” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Additionally regarding claim 8, the phrasing “comprises an edge having a radius of less than 5 μm” is unclear as to how as sharp edge can have a radius.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-8, 13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rogers (US 20200155047 A1).
Regarding claim 1, Rogers teaches a liquid sampling device comprising a support structure with a microfluidic arrangement having a liquid reception interface that is fluidly connected to a reservoir chamber by a capillary fluid passageway and a microfluidic valve, the microfluidic valve being connected to a measuring chamber ([Abstract] “microfluidic systems for monitoring a biofluid property and related methods;” microfluidic system 10, Fig. 1, Fig. 2; Fig. 7), wherein:
the liquid reception interface (biofluid inlet 50), the capillary fluid passageway (microfluidic networks 30, 40), the reservoir chamber and the microfluidic valve are configured to allow liquid entering the liquid reception interface to flow into the reservoir chamber by way of capillary forces in the capillary fluid passageway ([0450] “The first layer of a polyester mesh capture the insensible sweat came from skin by capillary force.” [0401] “plurality of reservoir chambers 60. A plurality of capillary burst valves 70 may be in fluidic contact the microfluidic conduit network, with a valve positioned between fluidically adjacent reservoir chambers.”) while being prevented from passing the microfluidic valve unless a predetermined static pressure difference (∆PT) over the microfluidic valve is exceeded (capillary burst valves 70; [0416] “In FIG. 7, a microfluidic system has 12 values with different bursting pressure accomplished by changing the valve size from 120 μm to 10 μm (FIG. 7). The bursting pressure increases. If the sweat has pressure higher than such valves it will burst and stop at certain valve. To visualize the bursting of valve, cobalt chloride is used in the chamber. When there is bursting the color is changed to red. The device may detect from 1.2 kPa to 6.5 kPa, for example. In vitro tests measure the bursting pressure of the device and numerical analysis yielded well matched values.”),
the microfluidic valve is a passive valve without moving parts, the passing of liquid through the microfluidic valve is controlled by capillary action and a static pressure difference over the microfluidic valve ([0414] “When sweat is coming from the sweat gland, if the pressure from sweat gland is higher than the bursting pressure of valve, it will burst in the chamber.”), and
the microfluidic valve has a microfluidic valve entrance and a microfluidic valve exit, and the capillary fluid passageway and the reservoir chamber are configured and arranged to cause a predetermined static pressure at an entrance side of the microfluidic valve that promotes a flow of liquid through the microfluidic valve into the measuring chamber once the reservoir chamber is completely filled (Fig. 2b; Fig. 7C).
Regarding claim 3, Rogers teaches the liquid sampling device according to claim 1, wherein a measuring chamber exit is connected to a test unit ([0401] “Microfluidic outlet conduit 90 may connect to the chamber 60;” [0451] “The other side of the polyester mesh is attached to a dried PVA hydrogel with diameter of 1 cm and thickness of 400 μm including a chloride assay reagent that is installed on the top layer of PDMS”).
Regarding claim 4, Rogers teaches the liquid sampling device according to claim 3, wherein the test unit comprises a liquid flow assay ([0451] “The other side of the polyester mesh is attached to a dried PVA hydrogel with diameter of 1 cm and thickness of 400 μm including a chloride assay reagent that is installed on the top layer of PDMS… The reagent of the chloride assay kit introduced in the PVA hydrogel react with the chloride in the sweat and its color changes to blue in dependence of the chloride concentration. From the amount of sweat loss measured from the other area and the intensity of the color, the concentration can be calculated.”).
Regarding claim 5, Rogers teaches the liquid sampling device according to claim 1, wherein a microfluidic valve entrance is connected to the reservoir chamber by a fluid passageway having a width between 100 micrometers (μm) and 150 μm (Fig. 7B, valve #9).
Regarding claim 6, Rogers teaches the liquid sampling device according to claim 1, wherein a microfluidic valve exit is connected to the measuring chamber by a connecting fluid passageway having a width between 100 μm and 150 μm (Fig. 7B, valve #9).
Regarding claim 7, Rogers teaches the liquid sampling device according to claim 1, wherein a microfluidic valve has a valve chamber having a width of more than 200 μm (Fig. 2a, valve #3).
Regarding claim 8, Rogers teaches the liquid sampling device according to claim 7, wherein at the microfluidic valve entrance a sharp transition from a first width of about 80 μm to 160 μm to a second width of the valve chamber is provided, wherein the sharp transition comprises an edge having a radius of less than 5 μm (Fig. 2a, valve #3).
Regarding claim 13, Rogers teaches the liquid sampling device according to claim 1, wherein the support structure with the microfluidic arrangement is an integral part made from thermoplastic material ([0030] “flexible substrate having a skin-facing surface and a back-facing surface; a microfluidic network at least partially embedded in or supported by the flexible substrate; … the flexible substrate is at least partially formed of a thermoplastic elastomer or a polymer configured to provide a high barrier to vapor or liquid water transmission.” [0083] “Any of the systems may have a flexible substrate that comprises a material selected from the group consisting of polydimethylsiloxane (PDMS), polyurethane, cellulose paper, cellulose sponge, polyurethane sponge, polyvinyl alcohol sponge, silicone sponge, polystyrene, polyimide, SU-8, wax, olefin copolymer, polymethyl methacrylate (PMMA), polycarbonate, polyvinyl chloride, chitosan, and any combination thereof.”).
Regarding claim 15, Rogers teaches the liquid sampling device according to claim 13, wherein the thermoplastic material is one of polycarbonate, cyclopolyolefins, poly-(methyl) methacrylate ([0083] “Any of the systems may have a flexible substrate that comprises a material selected from the group consisting of polydimethylsiloxane (PDMS), polyurethane, cellulose paper, cellulose sponge, polyurethane sponge, polyvinyl alcohol sponge, silicone sponge, polystyrene, polyimide, SU-8, wax, olefin copolymer, polymethyl methacrylate (PMMA), polycarbonate, polyvinyl chloride, chitosan, and any combination thereof.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 20200155047 A1) in view of Gilbert (US 20120261013 A1).
Regarding claim 2, Rogers teaches the liquid sampling device according to claim 1. However, Rogers fails to disclose an air passageway for injecting an air bubble into the connection fluid passageway connecting the microfluidic valve and the measuring chamber. Gilbert teaches a microfluidic system includes a bubble valve for regulating fluid flow through a microchannel.
Gilbert discloses wherein an air passageway branches off a connection fluid passageway connecting the microfluidic valve and the measuring chamber, the air passageway connecting to injection means for injecting an air bubble via the air passageway into the connection fluid passageway ([0053] “When the actuator is fully actuated, the bubble valve 10 is switched to a closed state, as illustrated in FIG. 5c. As shown, in the closed state, the meniscus 80 deflects fully to form and introduce a gas bubble 81 into the microchannel 21. The gas bubble 81 is retained by the hydrophobic patch 22 formed in the channel wall opposite the slot 31b. As a result, the liquid flow in the channel is substantially blocked. By reducing the pressure on the meniscus 80, the bubble valve 10 can be brought from the `closed` state of FIG. 5c via the `pinched` state of FIG. 5b back to the `open` state of FIG. 5a.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Rogers to include an air passageway and injection means for injecting an air bubble into the connection fluid passageway as disclosed in Gilbert to effectively control the flow of liquids in microfluidic systems using a bubble valve, avoiding the need to heat the fluid or complex on-chip circuitry (Gilbert [0010]).
Regarding claim 14, Rogers teaches a method of collecting a fluid sample, with the liquid sampling device according to claim 1, wherein the method comprises:
bringing a fluid to be sampled in contact with the liquid reception interface, letting the reservoir chamber automatically fill by way of capillary forces in the capillary fluid passageway (biofluid inlet 50; [0450] “The first layer of a polyester mesh capture the insensible sweat came from skin by capillary force.” [0401] “plurality of reservoir chambers 60. A plurality of capillary burst valves 70 may be in fluidic contact the microfluidic conduit network, with a valve positioned between fluidically adjacent reservoir chambers.”),
allowing sample fluid to pass the microfluidic valve once the reservoir chamber is completely filled, allowing the measuring chamber to fill completely, and once the measuring chamber is completely filled ([0416] “In FIG. 7, a microfluidic system has 12 values with different bursting pressure accomplished by changing the valve size from 120 μm to 10 μm (FIG. 7). The bursting pressure increases. If the sweat has pressure higher than such valves it will burst and stop at certain valve. To visualize the bursting of valve, cobalt chloride is used in the chamber. When there is bursting the color is changed to red. The device may detect from 1.2 kPa to 6.5 kPa, for example. In vitro tests measure the bursting pressure of the device and numerical analysis yielded well matched values.”).
However, Rogers fails to disclose interrupting a transfer of the fluid by injecting an air bubble.
Gilbert discloses interrupting a transfer of the fluid through the microfluidic valve by injecting an air bubble in a connecting fluid passageway between the microfluidic valve and the measuring chamber ([0053] “When the actuator is fully actuated, the bubble valve 10 is switched to a closed state, as illustrated in FIG. 5c. As shown, in the closed state, the meniscus 80 deflects fully to form and introduce a gas bubble 81 into the microchannel 21. The gas bubble 81 is retained by the hydrophobic patch 22 formed in the channel wall opposite the slot 31b. As a result, the liquid flow in the channel is substantially blocked. By reducing the pressure on the meniscus 80, the bubble valve 10 can be brought from the `closed` state of FIG. 5c via the `pinched` state of FIG. 5b back to the `open` state of FIG. 5a.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Rogers to include interrupting a transfer of the fluid by injecting an air bubble as disclosed in Gilbert to effectively control the flow of liquids in microfluidic systems using a bubble valve, avoiding the need to heat the fluid or complex on-chip circuitry (Gilbert [0010]).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 20200155047 A1) in view of Sloan (US 20150273467 A1).
Regarding claim 9, Rogers teaches the liquid sampling device according to claim 1. However, Rogers fails to disclose a skin-piercing mechanism. Sloan teaches methods and devices for liquid sample collection from a subject.
Sloan discloses further comprising a skin-piercing needle or lancet (Fig. 77B, [0193] “the tissue penetrating member 1292 comprises a lancet”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Rogers to include a skin-piercing needle or lancet as disclosed in Sloan to release the bodily fluid sample from the subject (Sloan [0226]).
Regarding claim 10, the combination of Rogers/Sloan discloses the liquid sampling device according to claim 9, wherein the skin-piercing needle or lancet is arranged proximate the liquid reception interface (Sloan: [0193] “FIG. 77B shows that the sample obtained from a wound or wounds created by tissue penetrating members 1292 may flow through channel(s), capillary tube(s), or other pathways as indicated by arrow 1295 to a channel 1299 or other inlet to a separation device.”).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 20200155047 A1) in view of Davis (US 20070031283 A1).
Regarding claim 11, Rogers teaches the liquid sampling device according to claim 1. However, Rogers fails to disclose the specific capacity of the measuring chamber to be 0.8-1.2 microliters. Davis teaches performing a test to detect and/or quantify the presence of an analyte of interest within a sample using a portable instrument.
Davis discloses wherein the measuring chamber has a capacity of between 0.8 to 1.2 μL (microliters) ([0234] “Depending on the detection method, the measurement zone may be all or a portion of the incubation zone 2013;” [0145] “In some embodiments, the volume of each incubation zone ranges from 1 nL to 1 mL; from 10 nL to 100 .mu.L; from 100 nL to 10 .mu.L; from 300 nL to 3 .mu.L; or 1 nL or less. Exemplary incubation zone volumes include 1 nL, 3 nL, 10 nL, 30 nL, 100 nL, 300 nL, 500 nL, 800 nL, 1 .mu.L, 2 .mu.L, 3 .mu.L, 5 .mu.L, 10 .mu.L, 30 .mu.L, and 100 .mu.L. In some embodiments, all the incubation zones have the same volume. In other embodiments, the incubation zones can have differing volumes.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Rogers to include the measuring chamber to have a capacity of 0.8-1.2 microliters as disclosed in Davis to minimize the volume of sample required in minimizing the volume of the measurement/incubation zones while also ensuring enough of the analytes of interest is present (Davis [0140]).
Regarding claim 12, Rogers teaches the liquid sampling device according to claim 1. However, Rogers fails to disclose the specific capacity of the measuring chamber to be between 2.5 and 3.0 μL.
Davis discloses wherein the reservoir chamber has a capacity of between 2.5 and 3.0 μL([0234] “Depending on the detection method, the measurement zone may be all or a portion of the incubation zone 2013;” [0145] “In some embodiments, the volume of each incubation zone ranges from 1 nL to 1 mL; from 10 nL to 100 .mu.L; from 100 nL to 10 .mu.L; from 300 nL to 3 .mu.L; or 1 nL or less. Exemplary incubation zone volumes include 1 nL, 3 nL, 10 nL, 30 nL, 100 nL, 300 nL, 500 nL, 800 nL, 1 .mu.L, 2 .mu.L, 3 .mu.L, 5 .mu.L, 10 .mu.L, 30 .mu.L, and 100 .mu.L. In some embodiments, all the incubation zones have the same volume. In other embodiments, the incubation zones can have differing volumes.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Rogers to include the measuring chamber to have a capacity of 0.8-1.2 microliters as disclosed in Davis to minimize the volume of sample required in minimizing the volume of the measurement/incubation zones while also ensuring enough of the analytes of interest is present (Davis [0140]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLY HALPRIN whose telephone number is (703)756-1520. The examiner can normally be reached 12PM-8PM ET.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791