DETAILED ACTION
Claims 31-50 are hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/24/2025 is being considered by the examiner.
Claim Interpretation - 35 USC § 112(f)
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:
Claims 31 and 41: The claim limitation “a selective recognition element disposed on the first electrode and configured to generate a first electrical response …” 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 “element” coupled with functional language “configured to generate a first electrical response …” 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 “element”.
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:
“The selective recognition element preferably includes at least one of an enzyme, aptamer, antibody, capture probe, ionophore, catalyst, biocatalyst, DNA, RNA, organelle, or cell”, or equivalents thereof, as described in para. [0031] of the disclosure filed on 09/10/2024.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 31-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 31 and 41:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 31 is directed to a device, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 41 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 31 and 41 recite an abstract idea. In particular, the claims recite the following:
Determine a resultant signal representative of the first electrical response generated at the first electrode and the second electrical response generated at the second electrode based on a ratio of the first electrical response and the second electrical response.
These elements recited in the claims are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Determining a ratio of the first electrical response and the second electrical response involves mathematical calculations. Additionally, determining a ratio of the first electrical response and the second electrical response involves a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can reasonably view a first electrical response value and a second electrical response value on a piece of paper and mentally determine a ratio of the two responses. There is nothing to suggest an undue level of complexity in the determining steps.
Prong Two: Claims 31 and 41 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a processor …” (claim 31)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “a microneedle array …” (claim 31 and claim 41)); the post-solution activity of: (e.g. N/A); using generic data-outputting components (e.g. N/A)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a microneedle array comprising a substrate and a plurality of microneedles … a selective recognition element … the first electrical response and the second electrical response resulting from application of a bias potential …”, is well-understood, routine, and conventional methods of data gathering as disclosed by Pushpala et al. (US 20140275897 A1) - para. [0020-0025], para. [0030-0033].
Further, “a processor” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 31 and 41 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution steps of necessary data gathering, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 32-40 and 42-50 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“the resultant signal comprises an analyte signal representative of a concentration of the analyte at the first electrode” (claim 39), “the resultant signal comprises an analyte signal representative of a concentration of the analyte at the first electrode” (claim 49)),
Further describe the pre-solution activity (or the structure used for such activity) (“the first electrode further comprises a first membrane disposed on the selective recognition element” (claim 32), “the second electrode comprises a second membrane disposed on the second electrode” (claim 33), “the second membrane is disposed directly on the second electrode” (claim 34), “the first membrane and the second membrane comprise the same material” (claim 36), “the first impedance comprises a first frequency- dependent impedance and the second impedance comprises a second frequency-dependent impedance” (claim 36), “the bias potential applied to the first electrode and to the second electrode is identical” (claim 37), “the bias potential applied to the first electrode and to the second electrode comprises an AC potential” (claim 38), “each of the first electrode and the second electrode is disposed at a distal end of the respective microneedle” (claim 40), “the first electrode further comprises a first membrane disposed on the selective recognition element” (claim 42), “the second electrode comprises a second membrane disposed on the second electrode” (claim 43), “the second membrane is disposed directly on the second electrode” (claim 44), “the first membrane and the second membrane comprise the same material” (claim 45), “the first impedance comprises a first frequency- dependent impedance and the second impedance comprises a second frequency-dependent impedance” (claim 46), “the bias potential applied to the first electrode and to the second electrode is identical” (claim 47), “the bias potential applied to the first electrode and to the second electrode comprises an AC potential” (claim 48), “each of the first electrode and the second electrode is disposed at a distal end of the respective microneedle” (claim 50)),
Further describe the computer implementation (N/A), and
Further describe the post-solution activity (N/A) (recited at a high level of generality).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 31-50 are rejected.
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.
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 31-35, 37, 39-45, 47, and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala et al. (US 20140275897 A1), hereinafter referred to as Pushpala, in view of Gottlieb et al. (US 20100030045 A1), hereinafter referred to as Gottlieb.
The claims are generally directed towards a device comprising: a microneedle array comprising a substrate and a plurality of microneedles extending from a first side of the substrate, the plurality of microneedles comprising: a first microneedle comprising a first electrode; a second microneedle comprising a second electrode; and a selective recognition element disposed on the first electrode and configured to generate a first electrical response arising from an interaction of the selective recognition element and an analyte; and a processor, wherein the first microneedle and the second microneedle are configured to be positioned within a viable epidermis or a dermis of a user, wherein the processor is configured to measure the first electrical response comprising a first impedance from the first electrode and a second electrical response comprising a second impedance from the second electrode, the first electrical response and the second electrical response resulting from application of a bias potential applied to each of the first electrode and the second electrode, and wherein the processor is configured to determine a resultant signal representative of the first electrical response generated at the first electrode and the second electrical response generated at the second electrode based on a ratio of the first electrical response and the second electrical response.
Regarding claim 31, Pushpala discloses a device (Abstract, Fig. 1, para. [0020]) comprising:
a microneedle array comprising a substrate and a plurality of microneedles extending from a first side of the substrate (Fig. 1, Fig. 2, para. [0020-0025], “microsensor comprises an array of filaments … comprise a substrate and a conductive layer …”), the plurality of microneedles comprising:
a first microneedle comprising a first electrode (Fig. 1, Fig. 2, para. [0020-0025], “each filament of the array of filaments comprise a substrate and a conductive layer configured to facilitate analyte detection … multiple subarrays of the filaments …”);
a second microneedle comprising a second electrode (Fig. 1, Fig. 2, para. [0020-0025], “each filament of the array of filaments comprise a substrate and a conductive layer configured to facilitate analyte detection … multiple subarrays of the filaments …”); and
a selective recognition element disposed on the first electrode and configured to generate a first electrical response arising from an interaction of the selective recognition element and an analyte (Fig. 2, element 160, para. [0030], “sensing layer functions to enable transduction of an ionic concentration … sensing layer can include molecules (e.g., glucose oxidase …”); and
a processor (Fig. 1B, element 115, para. [0021], “microsensor can also be coupled to an electronics module …”),
wherein the first microneedle and the second microneedle are configured to be positioned within a viable epidermis or a dermis of a user (para. [0020], “microsensor is configured to penetrate the user’s stratum corneum in order to sense analytes …”),
wherein the processor is configured to measure the first electrical response comprising a first impedance from the first electrode and a second electrical response comprising a second impedance from the second electrode, the first electrical response and the second electrical response resulting from application of a bias potential applied to each of the first electrode and the second electrode (para. [0020], “amperometric measurement …”, para. [0021], “microsensor can also be coupled to an electronics module, such that sensed analytes result in a signal (e.g. … impedance) …”, para. [0032], “held at an electric potential …”).
However, Pushpala does not explicitly disclose wherein the processor is configured to determine a resultant signal representative of the first electrical response generated at the first electrode and the second electrical response generated at the second electrode based on a ratio of the first electrical response and the second electrical response.
Gottlieb teaches of an analogous device (Abstract, para. [0008]) comprising a first electrode, a second electrode, and a selective recognition element disposed on the first electrode and configured to generate a first electrical response arising from an interaction of the selective recognition element and an analyte (para. [0144]). Gottlieb further teaches a processor is configured to determine a resultant signal representative of a first electrical response generated at the first electrode and a second electrical response generated at the second electrode based on a ratio of the first electrical response and the second electrical response (para. [0140], para. [0163], para. [0190]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and processor disclosed by Pushpala to additionally determine a resultant signal representative of the first electrical response generated at the first electrode and the second electrical response generated at the second electrode based on a ratio of the first electrical response and the second electrical response, as taught by Gottlieb. This is because Gottlieb teaches comparing a working electrode with a background signal from a second electrode allows for noise and background signals to be removed to obtain a more accurate concentration of an analyte (para. [0140], para. [0190]).
Regarding claim 32, modified Pushpala discloses the device of claim 31, wherein the first electrode further comprises a first membrane disposed on the selective recognition element (Fig. 2F, element 190, para. [0026], para. [0035], “temporary functional layer … a polymer …”).
Regarding claim 33, modified Pushpala discloses the device of claim 32, wherein the second electrode comprises a second membrane disposed on the second electrode (Fig. 2F, element 190, para. [0026], para. [0035], “temporary functional layer … a polymer …”).
Regarding claim 34, modified Pushpala discloses the device of claim 33, wherein the second membrane is disposed directly on the second electrode (Fig. 2F, element 190, para. [0026], para. [0035], “temporary functional layer … a polymer …”).
Regarding claim 35, modified Pushpala discloses the device of claim 34, wherein the first membrane and the second membrane comprise the same material (Fig. 2F, element 190, para. [0026], para. [0035], “temporary functional layer … a polymer …”).
Regarding claim 37, modified Pushpala discloses the device of claim 31.
However, modified Pushpala does not explicitly disclose wherein the bias potential applied to the first electrode and to the second electrode is identical.
Gottlieb further teaches the bias potential applied to the first electrode and to the second electrode is identical (para. [0140], para. [0162-0163]). 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 bias potentials taught by modified Pushpala to explicitly be identical, as taught by Gottlieb. This is because Gottlieb teaches identical potentials to a working electrode coated with a recognition element and a bare working electrode allows for background noise to be determined, and removed (para. [0140], para. [0190]).
Regarding claim 39, modified Pushpala discloses the device of claim 31.
However, modified Pushpala does not explicitly disclose wherein the resultant signal comprises an analyte signal representative of a concentration of the analyte at the first electrode.
Gottlieb further teaches the resultant signal comprises an analyte signal representative of a concentration of the analyte at the first electrode (para. [0140], para. [0163], para. [0190]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by modified Pushpala to have the resultant signal comprise an analyte signal representative of a concentration of the analyte at the first electrode, as taught by Gottlieb. This is because Gottlieb teaches comparing the first electrical response and the second electrical response allows for noise and background signals to be removed to obtain a more accurate concentration of an analyte (para. [0140], para. [0190]).
Regarding claim 40, modified Pushpala discloses the device of claim 31, wherein each of the first electrode and the second electrode is disposed at a distal end of the respective microneedle (Fig. 2, element 140, para. [0020], para. [0028]).
Regarding claim 41, Pushpala discloses a method (Abstract, Fig. 1, para. [0020-0021]) comprising:
positioning a first microneedle comprising a first electrode and a second microneedle comprising a second electrode within a viable epidermis or a dermis of a user (Fig. 1, Fig. 2, para. [0020], “microsensor is configured to penetrate the user’s stratum corneum in order to sense analytes …”, para. [0020-0025], “each filament of the array of filaments comprise a substrate and a conductive layer configured to facilitate analyte detection … multiple subarrays of the filaments …”), wherein a selective recognition element is disposed on the first electrode and configured to generate a first electrical response arising from an interaction of the selective recognition element and an analyte (Fig. 2, element 160, para. [0030], “sensing layer functions to enable transduction of an ionic concentration … sensing layer can include molecules (e.g., glucose oxidase …”);
applying a bias potential to each of the first electrode and the second electrode (para. [0020], “amperometric measurement …”, para. [0032], “held at an electric potential …”);
measuring the first electrical response from the first electrode and a second electrical response from the second electrode, wherein the first electrical response comprises a first impedance from the first electrode and the second electrical response comprises a second impedance from the second electrode (para. [0020], “amperometric measurement …”, para. [0021], “microsensor can also be coupled to an electronics module, such that sensed analytes result in a signal (e.g. … impedance) …”, para. [0032], “held at an electric potential …”).
However, Pushpala does not explicitly disclose determining a resultant signal representative of the first electrical response generated at the first electrode and the second electrical response generated at the second electrode based on a ratio of the first electrical response and the second electrical response.
Gottlieb teaches of an analogous method (Abstract, para. [0008]) comprising a first electrode, a second electrode, and a selective recognition element disposed on the first electrode and configured to generate a first electrical response arising from an interaction of the selective recognition element and an analyte (para. [0144]). Gottlieb further teaches the method determines a resultant signal representative of the first electrical response generated at the first electrode and the second electrical response generated at the second electrode based on a ratio of the first electrical response and the second electrical response (para. [0140], para. [0163], para. [0190]). 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 method taught by Pushpala to additionally determine a resultant signal representative of the first electrical response generated at the first electrode and the second electrical response generated at the second electrode based on a ratio of the first electrical response and the second electrical response, as taught by Gottlieb. This is because Gottlieb teaches comparing a working electrode with a background signal from a second electrode allows for noise and background signals to be removed to obtain a more accurate concentration of an analyte (para. [0140], para. [0190]).
Regarding claim 42, modified Pushpala discloses the method of claim 41, wherein the first electrode further comprises a first membrane disposed on the selective recognition element (Fig. 2F, element 190, para. [0026], para. [0035], “temporary functional layer … a polymer …”).
Regarding claim 43, modified Pushpala discloses the method of claim 42, wherein the second electrode comprises a second membrane disposed on the second electrode (Fig. 2F, element 190, para. [0026], para. [0035], “temporary functional layer … a polymer …”).
Regarding claim 44, modified Pushpala discloses the method of claim 43, wherein the second membrane is disposed directly on the second electrode (Fig. 2F, element 190, para. [0026], para. [0035], “temporary functional layer … a polymer …”).
Regarding claim 45, modified Pushpala discloses the method of claim 44, wherein the first membrane and the second membrane comprise the same material (Fig. 2F, element 190, para. [0026], para. [0035], “temporary functional layer … a polymer …”).
Regarding claim 47, modified Pushpala discloses the method of claim 41.
However, modified Pushpala does not explicitly disclose wherein the bias potential applied to the first electrode and to the second electrode is identical.
Gottlieb further teaches the bias potential applied to the first electrode and to the second electrode is identical (para. [0140], para. [0162-0163]). 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 bias potentials taught by modified Pushpala to explicitly be identical, as taught by Gottlieb. This is because Gottlieb teaches identical potentials to a working electrode coated with a recognition element and a bare working electrode allows for background noise to be determined, and removed (para. [0140], para. [0190]).
Regarding claim 49, modified Pushpala discloses the method of claim 41.
However, modified Pushpala does not explicitly disclose wherein the resultant signal comprises an analyte signal representative of a concentration of the analyte at the first electrode.
Gottlieb further teaches the resultant signal comprises an analyte signal representative of a concentration of the analyte at the first electrode (para. [0140], para. [0163], para. [0190]). 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 method taught by modified Pushpala to have the resultant signal comprise an analyte signal representative of a concentration of the analyte at the first electrode, as taught by Gottlieb. This is because Gottlieb teaches comparing the first electrical response and the second electrical response allows for noise and background signals to be removed to obtain a more accurate concentration of an analyte (para. [0140], para. [0190]).
Regarding claim 50, modified Pushpala discloses the method of claim 41, wherein each of the first electrode and the second electrode is disposed at a distal end of the respective microneedle (Fig. 2, element 140, para. [0020], para. [0028]).
Claims 36, 38, 46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala et al. (US 20140275897 A1), hereinafter referred to as Pushpala, in view of Gottlieb et al. (US 20100030045 A1), hereinafter referred to as Gottlieb as applied to claims 31 and 41 above, and further in view of Bohm et al. (US 20120265037 A1), hereinafter referred to as Bohm.
Regarding claim 36, modified Pushpala discloses the device of claim 31.
However, modified Pushpala does not explicitly disclose wherein the first impedance comprises a first frequency-dependent impedance and the second impedance comprises a second frequency-dependent impedance.
Bohm teaches of an analogous device comprising a first electrode and a second electrode (Abstract, Fig. 23, para. [0384]), and measuring a first impedance and a second impedance resulting from application of a bias potential (para. [0330]). Bohm further teaches the first impedance comprises a first frequency-dependent impedance and the second impedance comprises a second frequency-dependent impedance (para. [0330]). 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 impedances to be frequency dependent, as taught by Bohm. This is because Bohm teaches an AC voltage can be applied to determine an impedance at different frequencies if desired (para. [0330]).
Regarding claim 38, modified Pushpal discloses the device of claim 31.
However, modified Pushpala does not explicitly disclose wherein the bias potential applied to the first electrode and to the second electrode comprises an AC potential.
Bohm teaches of an analogous device comprising a first electrode and a second electrode (Abstract, Fig. 23, para. [0384]), and measuring a first impedance and a second impedance resulting from application of a bias potential (para. [0330]). Bohm further teaches the bias potential applied to the first electrode and to the second electrode comprises an AC potential (para. [0330]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify bias potentials, as taught by Bohm. This is because Bohm teaches an AC voltage can be applied to determine an impedance at different frequencies if desired (para. [0330]).
Regarding claim 46, modified Pushpala discloses the method of claim 41.
However, modified Pushpala does not explicitly disclose wherein the first impedance comprises a first frequency-dependent impedance and the second impedance comprises a second frequency-dependent impedance.
Bohm teaches of an analogous method of using a device comprising a first electrode and a second electrode (Abstract, Fig. 23, para. [0384]), and measuring a first impedance and a second impedance resulting from application of a bias potential (para. [0330]). Bohm further teaches the first impedance comprises a first frequency-dependent impedance and the second impedance comprises a second frequency-dependent impedance (para. [0330]). 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 impedances to be frequency dependent, as taught by Bohm. This is because Bohm teaches an AC voltage can be applied to determine an impedance at different frequencies if desired (para. [0330]).
Regarding claim 48, modified Pushpala discloses the method of claim 41.
However, modified Pushpala does not explicitly disclose wherein the bias potential applied to the first electrode and to the second electrode comprises an AC potential.
Bohm teaches of an analogous method of using a device comprising a first electrode and a second electrode (Abstract, Fig. 23, para. [0384]), and measuring a first impedance and a second impedance resulting from application of a bias potential (para. [0330]). Bohm further teaches the bias potential applied to the first electrode and to the second electrode comprises an AC potential (para. [0330]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify bias potentials, as taught by Bohm. This is because Bohm teaches an AC voltage can be applied to determine an impedance at different frequencies if desired (para. [0330]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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