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 .
Claims Pending
Applicant’s cancellation of claims 28 and 31 and addition of claims 32-33 in the response filed 04/23/2026 is acknowledged.
Claims 1-6, 8-13, 15-27, and 32-33 are currently under examination.
Election/Restrictions
Applicant’s election of Invention 1, Species C, Claims 1, 4-6, 8-13, 15-20, and 32-33, in the reply filed on 04/23/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2-3 and 21-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions and Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/23/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1, 4-6, 8-13, 15-20, and 32-33 are hereby under examination.
Claim Objections
Claim 10 objected to because of the following informalities:
In Claim 10, “wherein the plurality of capture agents is configured to bind to an analyte or detect a condition selected from the group consisting of an ion, a small molecule, a metal, a metal ion, a metal atom, a particle, a metal particle, a magnetic particle, a temperature, a peptide, a protein, a cytokine, a hydrophilic sample, or a hydrophobic sample”, should read -wherein the plurality of capture agents is configured to bind to an analyte selected from the group consisting of an ion, a small molecule, a metal, a metal ion, a metal atom, a particle, a metal particle, a magnetic particle, a peptide, a protein, a cytokine, a hydrophilic sample, or a hydrophobic sample, or wherein the plurality of capture agents is configured to detect a condition selected from the group consisting of temperature-.
(Examiner's Note: The only “condition” present in claim 10 is “temperature”, which creates confusion as temperature is the sole condition included in the center of a list of analytes. As such, it is recommended that the applicant revise the claim. For example, the applicant’s spec. states “Non-limiting analytes can include an ion, a small molecule, a metal (e.g., a metal ion or a metal atom), a particle (e.g., a metal particle or a magnetic particle), a peptide, a protein, a cytokine, a hydrophilic sample, or a hydrophobic sample (e.g., oil, gasoline, and the like). Non-limiting conditions can include a temperature, an ionic state, a hydration level, and the like” (Par. 122 of applicant’s spec.), where the temperature is the only “condition” present in the above claim.)
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:
Claim 10: The claim limitation “capture agents is configured to bind to an analyte or detect a condition selected from the group consisting of an ion, a small molecule, a metal, a metal ion, a metal atom, a particle, a metal particle, a magnetic particle, a temperature, a peptide, a protein, a cytokine, a hydrophilic sample, or a hydrophobic sample” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “capture agents” coupled with functional language “configured to bind to an analyte or detect a condition selected from the group consisting of an ion, a small molecule, a metal, a metal ion, a metal atom, a particle, a metal particle, a magnetic particle, a temperature, a peptide, a protein, a cytokine, a hydrophilic sample, or a hydrophobic sample” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “capture agents”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“Capture agents can include any useful functional groups that allows for capture an analyte or detecting a condition. Such functional groups can include boronic acids or boronate groups (e.g., a compound having a —B(OH)2 group), Schiff bases (e.g., an imine), acrylic acids, amides, amines, thiols, ionizable groups (e.g., weakly acidic or basic groups, such as sulfonate, carboxylate, and/or quaternary ammonium groups), reducible groups (e.g., disulfide groups), charged groups (e.g., anionic or cationic groups), chelating groups (e.g., an aminopolycarboxylic acid, carboxylic acids, crown ethers, and the like), particles (e.g., magnetic particles)…” or equivalents thereof, as described in Par. 123 of the disclosure filed on 01/24/2024.
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 5 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.
Claim 5 recites the limitation “wherein the wall comprises an inner surface facing the internal bore, and wherein the inner surface is covalently bonded to the hydrogel”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what properties of the material of the inner surface allow for covalent bonding to the hydrogel. The applicant does state “the inner surface of the internal bore (within the hollow microneedle) can be surface modified to allow for cross-linking with the polymerizable groups or linker groups that are pendant from the backbone of the hydrogel” (Par. 92 of applicant’s spec.), however, this merely does not clarify the manner in which a covalent bond is formed. The applicant’s specification further states “Non-limiting hydrogel can include, e.g., poly(acrylamide) (PAAm), poly(acrylic acid) (PAA), poly(ethylene oxide) (PEO), poly(ethylene oxide)-block-poly(acrylic acid) (PEO-b-PAA), poly(N-isopropylacrylamide) (PNIPAAm), poly(ethylene oxide)-block-poly(N-isopropylacrylamide) (PEO-b-pNIPAAm),…” (Par. 24 of applicant’s spec.), which merely indicates what can be included in the hydrogel, and further states “The microneedle can, in some instances, include an optically transparent material to allow for sufficient detection of the optical output signal from the particles within the hydrogel. In further instances, the microneedle can include a porous material, which can increase diffusion of ISF or analytes from the ISF into the hydrogel. Non-limiting materials for the microneedle can include…” (Par. 129 of applicant’s spec.), which merely indicates potential microneedle materials, and further states “A surface of the microneedle (e.g., inner surface within the bore or outer surface of the microneedle) can be modified or surface treated to allow for further functionalization. For instance, the inner surface within the bore can be modified to allow for covalent binding to the responsive hydrogel…” (Par. 130 of applicant’s spec.), which merely indicates surface modification. Is the covalent bond meant to be a function of a matching between materials of the hydrogel and inner surface of the microneedle? Is the covalent bond a function of a certain coating or modification to the microneedle? Is the applicant simply claiming any type of covalent bond formation? As such, it is unclear as to the manner in which the covalent bond is formed. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the presence of any type of covalent bond.
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)(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.
The claims are generally directed towards a device with a microneedle comprising a wall and internal bore surrounded by the wall. The internal bore further comprises a hydrogel with optically active particles and capture agents.
Claim(s) 1, 6, 8-13, 15-17, and 33 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sia (US Pat. No. 10631766) hereinafter Sia.
Regarding claim 1, Sia discloses A device (Fig. 9A (sensing module -104)) comprising:
a microneedle (Fig. 9A (microneedle array – 108)(hollow scaffold – 810)) comprising a wall (Fig. 9A (observable outer wall of hollow scaffold – 810)) and an internal bore surrounded by the wall (Fig. 9A (internal bore of hollow scaffold 810 that is filled with hydrogel - 812)) (Col. 8, lines 62-67, “In some embodiments, the microneedle array 108 is formed as a hollow scaffold 810 and filled with a glucose-responsive hydrogel 812, as illustrated in FIGS. 9A-9B…”); and
a hydrogel disposed within the internal bore (Fig. 9A (internal bore of hollow scaffold 810 that is filled with hydrogel - 812)) (Col. 8, lines 62-67), wherein the hydrogel comprises a plurality of optically active particles (Col. 9, lines 1-6 “the glucose-responsive hydrogel can be formed by glucose-responsive dye conjugated to poly(2-hydroxyethyl methacrylate) or polyacrylamide. For example, the dye can be dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively…” (glucose-responsive dye with excitation and emission wavelengths)) and a plurality of capture agents (Fig. 9A, Col. 9, lines 1-6, “The glucose-responsive hydrogel can be formed by glucose-responsive dye conjugated to poly(2-hydroxyethyl methacrylate) or polyacrylamide. For example, the dye can be dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively.”) (Fig. 9A, Col. 10, lines 59-62, “The glucose-responsive dye molecule has a saccharide binding site, a dye to emit fluorescent light with intensity corresponding to glucose concentration, a monomer site to allow for the entire molecule to the polymer matrix”).
Regarding claim 6, Sia further discloses wherein the hydrogel comprises poly(acrylamide) (PAAm) (Fig. 9A, Col. 9, lines 1-6, “The glucose-responsive hydrogel can be formed by glucose-responsive dye conjugated to poly(2-hydroxyethyl methacrylate) or polyacrylamide. For example, the dye can be dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively.”), poly(acrylic acid) (PAA), poly(ethylene oxide) (PEO), poly(ethylene oxide)-block-poly(acrylic acid) (PEO-b-PAA), poly(N-isopropylacrylamide) (PNIPAAm), poly(ethylene oxide)-block-poly(N-isopropylacrylamide) (PEO-b-pNIPAAm), poly[poly(ethylene glycol) diacrylate] (p[PEGDA]), poly(acrylamide-co-poly(ethylene glycol) diacrylate) (p[AAM-co-PEGDA]), poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(caprolactone) (PCL), poly(aniline) (PANI), poly(N-(3-amidino)-aniline), poly(octamethylene citric acid), alginate, a poloxamer, poly(dimethylsiloxane), poly(butadiene), poly(isoprene ), or a copolymer thereof.
Regarding claim 8, Sia further discloses wherein the plurality of optically active particles comprises a carbon-based material (Col. 9, lines 3-6, “For example, the dye can be dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively.”).
Regarding claim 9, Sia further discloses wherein the carbon-based material comprises nanodiamonds, carbon nanotubes, carbon nanowires, or carbon particles (Col. 9, lines 3-6, “For example, the dye can be dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively.”).
Regarding claim 10, Sia further discloses wherein the plurality of capture agents is configured to bind to an analyte or detect a condition selected from the group consisting of an ion, a small molecule, a metal, a metal ion, a metal atom, a particle, a metal particle, a magnetic particle, a temperature, a peptide, a protein, a cytokine, a hydrophilic sample (Col. 9, lines 1-12 “The glucose-responsive hydrogel can be formed by glucose-responsive dye conjugated to poly(2-hydroxyethyl methacrylate) or polyacrylamide. For example, the dye can be dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively. The resulting fluorescence signal can be correlated to pre-calibrated glucose concentrations and can provide specificity within 60-200 mg/dL...”) (Fig. 9A, Col. 10, lines 59-62, “The glucose-responsive dye molecule has a saccharide binding site, a dye to emit fluorescent light with intensity corresponding to glucose concentration, a monomer site to allow for the entire molecule to the polymer matrix”), or a hydrophobic sample.
Regarding claim 11, Sia further discloses wherein the analyte is glucose (Col. 9, lines 1-12 “The glucose-responsive hydrogel can be formed by glucose-responsive dye conjugated to poly(2-hydroxyethyl methacrylate) or polyacrylamide. For example, the dye can be dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively. The resulting fluorescence signal can be correlated to pre-calibrated glucose concentrations and can provide specificity within 60-200 mg/dL...”) (Fig. 9A, Col. 10, lines 59-62, “The glucose-responsive dye molecule has a saccharide binding site, a dye to emit fluorescent light with intensity corresponding to glucose concentration, a monomer site to allow for the entire molecule to the polymer matrix”), lactate, uric acid, glutathione, carbon dioxide, or hydrogen peroxide.
Regarding claim 12, Sia further discloses wherein the plurality of capture agents is selected from the group consisting of boronic acids, Schiff bases, acrylic acids, amides, amines, thiols, ionizable groups, reducible groups, charged groups, chelating groups, particles, magnetic particles, temperature responsive groups, redox indicators, photosensitizers, dyes (Col. 9, lines 1-12 “The glucose-responsive hydrogel can be formed by glucose-responsive dye conjugated to poly(2-hydroxyethyl methacrylate) or polyacrylamide. For example, the dye can be dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively. The resulting fluorescence signal can be correlated to pre-calibrated glucose concentrations and can provide specificity within 60-200 mg/dL...”) (Fig. 9A, Col. 10, lines 59-62, “The glucose-responsive dye molecule has a saccharide binding site, a dye to emit fluorescent light with intensity corresponding to glucose concentration, a monomer site to allow for the entire molecule to the polymer matrix”), antibodies, nanostructures, and hydrophobic groups.
Regarding claim 13, Sia further discloses further comprising:
an optical source configured to transmit an optical input signal to the microneedle (Fig. 3A, Col. 4, lines 52-57, “light signal detector 308 can include a stack arrangement of light source 326, detector 320, and corresponding optics, as illustrated in FIGS. 3A-3B. In particular, the monitoring system 300 includes an interrogation module 102 with an insulated housing coupled to the sensing module 104 with microneedle array 108.”);
an optical sensor configured to receive an optical output signal from the microneedle (Fig. 3A, Col. 4-5, lines 66-3, “The photosensor 320 detects light in the second wavelength range that was emitted by the fluorophore. The wavelength selective filter 322 attenuates light in the first wavelength range and transmits light in the second wavelength range.”);
and a controller comprising a memory and a processor, wherein the controller is configured to be electrically connected to the optical source and the optical sensor (Col. 6, lines 55-64, “The PCB 304 can host electronics that, among other things, control the excitation light source from the LED 326, process the detected fluorescent light signal from the photosensor 320 (e.g., by using a microcontroller), amplify the detected fluorescent light signal, provide offset removal, calibrate the system at both the factory and user level, provide temperature correction, and allow for communication with separate systems (e g, using wireless protocol, such as Bluetooth, and/or to communicate with a smartphone, smart watch, or other remote system).”)(Col. 5, lines 23-25, “interrogating module 102 can further include a processor, such as a printed circuit board 304 (PCB), and a power source 302, such as a battery”).
Regarding claim 15, Sia further discloses further comprising: a wireless signal transmitter configured to transmit data from the controller or the memory to an external receiver (Col. 6, lines 55-64, “The PCB 304 can host electronics that, among other things, control the excitation light source from the LED 326, process the detected fluorescent light signal from the photosensor 320 (e.g., by using a microcontroller), amplify the detected fluorescent light signal, provide offset removal, calibrate the system at both the factory and user level, provide temperature correction, and allow for communication with separate systems (e g, using wireless protocol, such as Bluetooth, and/or to communicate with a smartphone, smart watch, or other remote system).”) (Col. 4, lines 31-34, “The interrogation module 102 can communicate with an external control unit 110 or other system, network, or module, via a wired or wireless connection.”).
Regarding claim 16, Sia further discloses further comprising a plurality of microneedles, wherein each of the plurality of microneedles comprises an internal bore and a hydrogel disposed therein (Fig. 9A (microneedle array – 108)) (Fig. 9A (internal bore of hollow scaffold 810 that is filled with hydrogel - 812)) (Col. 8, lines 62-67).
Regarding claim 17, Sia further discloses wherein the microneedle is configured to obtain a sample comprising interstitial fluid from a subject (Col. 8, lines 39-61, “For example, the sensing module 104 includes one or more microneedles (shown as array 108 in FIG. 8A, although a single microneedle is also possible). For example, the microneedles can have a height of 1000 μm (in a direction parallel to an axis thereof). The microneedles may be hollow, for example, having an inner diameter of between 100 μm and 200 μm and a wall thickness of 20 μm. The size of the microneedles allows the sensing module 104 to access the dermal interstitial fluid 809 of the skin 806 of the wearer in a minimally invasive manner, i.e., the limited height of the microneedle in insufficient to reach the capillary bed 808, which would cause bleeding, but is sufficient to penetrate the stratum corneum of the skin to access dermal interstitial fluid 809. The microneedle can include a glucose responsive polymer as the sensing material, thereby allowing the sensor to dwell within the dermal interstitial fluid for continuous monitoring. Each of the microneedles can further include a bevel to reduce pain during insertion. The sensing module 104 can be held to the skin by an adhesive 804, which may surround the array 108 such that when adhered to the skin a light-tight seal is formed around the array 108 to prevent inadvertent excitation of the fluorophore in the microneedles.”).
Regarding claim 33, Sia further discloses wherein the memory stores computer-executable instructions for controlling the processor to cause a sample within a microneedle to be analyzed by (Col. 6, lines 55-64, “The PCB 304 can host electronics that, among other things, control the excitation light source from the LED 326, process the detected fluorescent light signal from the photosensor 320 (e.g., by using a microcontroller), amplify the detected fluorescent light signal, provide offset removal, calibrate the system at both the factory and user level, provide temperature correction, and allow for communication with separate systems (e g, using wireless protocol, such as Bluetooth, and/or to communicate with a smartphone, smart watch, or other remote system).”)(Col. 5, lines 23-25, “interrogating module 102 can further include a processor, such as a printed circuit board 304 (PCB), and a power source 302, such as a battery”):
a) transmitting the optical input signal from the optical source to the microneedle, thereby allowing the optical input signal to be transmitted through the hydrogel disposed within the microneedle (Col. 6, lines 55-64, “The PCB 304 can host electronics that, among other things, control the excitation light source from the LED 326, process the detected fluorescent light signal from the photosensor 320 (e.g., by using a microcontroller), amplify the detected fluorescent light signal, provide offset removal, calibrate the system at both the factory and user level, provide temperature correction, and allow for communication with separate systems (e g, using wireless protocol, such as Bluetooth, and/or to communicate with a smartphone, smart watch, or other remote system).”) (Col. 8-9, lines 62-13);
b) receiving the optical output signal from the microneedle to the optical sensor, wherein the optical output signal is indicative of a presence or an absence of an analyte captured within the hydrogel (Col. 6, lines 55-64, “The PCB 304 can host electronics that, among other things, control the excitation light source from the LED 326, process the detected fluorescent light signal from the photosensor 320 (e.g., by using a microcontroller), amplify the detected fluorescent light signal, provide offset removal, calibrate the system at both the factory and user level, provide temperature correction, and allow for communication with separate systems (e g, using wireless protocol, such as Bluetooth, and/or to communicate with a smartphone, smart watch, or other remote system).”) (Col. 8-9, lines 62-13);
c) obtaining data from the optical sensor indicating the presence or absence of the analyte (Col. 6, lines 55-64, “The PCB 304 can host electronics that, among other things, control the excitation light source from the LED 326, process the detected fluorescent light signal from the photosensor 320 (e.g., by using a microcontroller), amplify the detected fluorescent light signal, provide offset removal, calibrate the system at both the factory and user level, provide temperature correction, and allow for communication with separate systems (e g, using wireless protocol, such as Bluetooth, and/or to communicate with a smartphone, smart watch, or other remote system).”) (Col. 8-9, lines 62-13); and
d) storing and/or transmitting the data (Col. 6, lines 55-64, “The PCB 304 can host electronics that, among other things, control the excitation light source from the LED 326, process the detected fluorescent light signal from the photosensor 320 (e.g., by using a microcontroller), amplify the detected fluorescent light signal, provide offset removal, calibrate the system at both the factory and user level, provide temperature correction, and allow for communication with separate systems (e g, using wireless protocol, such as Bluetooth, and/or to communicate with a smartphone, smart watch, or other remote system).”) (Col. 8-9, lines 62-13).
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) 4 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sia as applied to claim 1 above, and further in view of Mir (US Pub. No. 20110224515) hereinafter Mir.
Sia discloses the device of claim 1 above.
Regarding claim 4, Sia fails to explicitly disclose wherein the wall comprises glass, sapphire, diamond, ruby, silica, polycarbonate, poly(dimethylsiloxane), poly(vinyl chloride), poly(methyl methacrylate), polyethylene, and combinations thereof.
However, Sia does disclose wherein the wall comprises PEEK or other materials (Col. 8, lines 62-67).
Sia does teach in an alternate embodiment transparent materials (Col. 10, lines 36-38, “the tips of microneedles to the back of the array can be transparent to enable light transmittance between the detector system and the microneedle tip”).
Mir teaches wherein the wall comprises glass (Par. 30, “A number of substrate 24 and/or microneedle 26 materials maybe used, e.g. silicon, silicon dioxide, silicon nitride, all commonly used in microfabrication or, in general, dielectrics, plastics, metals, glass, quartz, or sapphire…”), sapphire, diamond, ruby, silica, polycarbonate, poly(dimethylsiloxane), poly(vinyl chloride), poly(methyl methacrylate), polyethylene, and combinations thereof.
Sia and Mir are considered to be analogous art to the claimed invention as they are involved with microneedles.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Sia with that of Mir to include wherein the wall comprises glass, sapphire, diamond, ruby, silica, polycarbonate, poly(dimethylsiloxane), poly(vinyl chloride), poly(methyl methacrylate), polyethylene, and combinations thereof through the substitution of materials as differing materials are known in the art (Mir (Par. 30)) (Sia (Col. 8, lines 62-67)) and it would have yielded predictable result of allowing for light to pass through the microneedle (Mir (Par. 30-31)).
Regarding claim 18, Sia fails to explicitly disclose wherein the microneedle extends from a planar substrate.
However, Sia does disclose wherein the microneedle extends from a substrate (Fig. 9A (observable that microneedle array – 108)) (Fig. 9A (internal bore of hollow scaffold 810 that is filled with hydrogel - 812)) (Col. 8, lines 62-67) (Col. 39-55, “the sensing module 104 includes one or more microneedles (shown as array 108 in FIG. 8A…”).
Mir teaches wherein the microneedle extends from a planar substrate (Par. 30, “A number of substrate 24 and/or microneedle 26 materials maybe used, e.g. silicon, silicon dioxide, silicon nitride, all commonly used in microfabrication or, in general, dielectrics, plastics, metals, glass, quartz, or sapphire…”) (Par. 29, “The at least one restoring spring 28 can be patterned in a number of geometries such as a spiral spring, a cantilever structure, or other geometries as long as they provide the freedom of movement that allows microneedle 26 to protrude far enough out of a plane defined by substrate 24 in order to penetrate a subject's skin to a desired depth.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Sia with that of Mir to include wherein the microneedle extends from a planar substrate through the substitution of materials as differing materials are known in the art (Mir (Par. 30)) and it would have yielded the same or similar results.
Regarding claim 19, modified Sia fails to explicitly disclose the limitations of the claim.
However, Mir further teaches wherein the planar substrate comprises a flexible substrate (Mir (Par. 30, “A number of substrate 24 and/or microneedle 26 materials maybe used, e.g. silicon, silicon dioxide, silicon nitride, all commonly used in microfabrication or, in general, dielectrics, plastics, metals, glass, quartz, or sapphire…”) (Par. 29, “The at least one restoring spring 28 can be patterned in a number of geometries such as a spiral spring, a cantilever structure, or other geometries as long as they provide the freedom of movement that allows microneedle 26 to protrude far enough out of a plane defined by substrate 24 in order to penetrate a subject's skin to a desired depth.”)). (Examiner's Note: flexible substrate as indicated in Par. 138 of the applicant’s spec.)
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Sia and Mir with that of Mir to include wherein the planar substrate comprises a flexible substrate for the reasoning as indicated in claim 18 above.
Regarding claim 20, modified Sia fails to explicitly disclose the limitations of the claim.
However, Mir further teaches wherein the flexible substrate comprises poly(dimethylsiloxane) (Mir (Par. 30, “A number of substrate 24 and/or microneedle 26 materials maybe used, e.g. silicon, silicon dioxide, silicon nitride, all commonly used in microfabrication or, in general, dielectrics, plastics, metals, glass, quartz, or sapphire…”) (Par. 29, “The at least one restoring spring 28 can be patterned in a number of geometries such as a spiral spring, a cantilever structure, or other geometries as long as they provide the freedom of movement that allows microneedle 26 to protrude far enough out of a plane defined by substrate 24 in order to penetrate a subject's skin to a desired depth.”)), poly(caprolactone), poly(lactic acid), or natural rubber.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Sia and Mir with that of Mir to include wherein the flexible substrate comprises poly(dimethylsiloxane), poly(caprolactone), poly(lactic acid), or natural rubber for the reasoning as indicated in claim 18 above.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sia as applied to claim 1 above, and further in view of Kam (US Pat. No. 9974471) hereinafter Kam.
Sia discloses device of claim 1 above.
Regarding claim 5, Sia further discloses wherein the wall comprises an inner surface facing the internal bore (Sia (Fig. 9A (inner surface of internal bore of hollow scaffold 810 that is filled with hydrogel - 812)) (Col. 8, lines 62-67)).
Sia fails to explicitly disclose wherein the inner surface is covalently bonded to the hydrogel.
However, Sia does disclose wherein the wall comprises materials (Sia (Col. 8, lines 62-67)) and hydrogel materials (Sia (Fig. 9A, Col. 9, lines 1-6, “The glucose-responsive hydrogel can be formed by glucose-responsive dye conjugated to poly(2-hydroxyethyl methacrylate) or polyacrylamide. For example, the dye can be dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively.”)).
Kam teaches wherein the inner surface is covalently bonded to the hydrogel (Kam (Col. 6, lines 43-48, “The nanosensors in a polymer matrix can be coated or bound covalently or non-covalently to the inner wall surface of the hollow micro-needles or can fill at least a portion of the internal hollow space of the micro-needle. The micro-needles, the nanosensors, and/or the polymer matrix can be biodegradable”)(Col. 8, lines 24-43, “The micro-needles of the device can be constructed from a variety of materials, including metals, ceramics, semiconductors, organics, polymers, and composites…”) (Col. 12, lines 41-43, “the nanosensor and catalytic agent can be embedded in a polymer matrix such as a hydrogel. Cofactors and other components support the catalytic agents can be included”)(Col. 12, lines 6-19, “representative examples of suitable biocompatible polymers include, without limitation, poly (caprolactone)(PCL), ethylene vinyl acetate polymer (EVA), poly(ethylene glycol)(PEG), poly(vinyl acetate)(PVA), poly(lactic acid)(PLA), poly(glycolic acid)(PGA), poly(lactic-co-gylcolic acid)(PLGA), chitosan, alginate, polylysine, collagen or mixtures…”)).
Sia and Kam are considered to be analogous art to the claimed invention as they are involved with microneedles.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Sia with that of Kam to include wherein the inner surface is covalently bonded to the hydrogel through the combination of references as differing binding types are known in the art (Kam (Col. 6, lines 43-48)), differing microneedle materials are known in the art (Kam (Col. 8, lines 24-43)), different polymer materials are known (Kam (Col. 12, lines 6-19)), and it would have yielded the predictable result of ensuring that the hydrogel remains in the proper location.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sia as applied to claim 1 above, and further in view of Sia.
Sia discloses the device of claim 1 above.
Regarding claim 32, Sia fails to explicitly disclose the limitations of the claim.
However, Sia does disclose wherein the plurality of optically active particles comprises an emission peak from about 450 - 485 nm (Col. 9, lines 4-6, “dibronic acid and pyrene dye having an excitation wavelength at 342 nm and an emission wavelength at 397 nm and 417 nm, respectively.”).
(Examiner's Note: “about” interpreted in light of the applicant’s spec., which states ““about” encompasses+/−10% of any recited value” (Par. 28 of applicant’s spec.))
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Sia with that of Sia to include wherein the plurality of optically active particles comprises an emission peak from about 450 - 485 nm because in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a primary facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Conclusion
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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