DETAILED ACTION
Claims 1-22 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 05/13/2025 is being considered by the examiner.
Claim Objections
Claims 12, 14, and 20 are objected to because of the following informalities:
Regarding claim 12, line 2 recites “wherein one or more”, however it appears it should read --wherein the one or more-- (emphasis added).
Regarding claim 14, line 2 recites “corresponding measurements”, however it appears it should read --corresponding to measurements-- (emphasis added).
Regarding claim 20, lines 1-2 recite “an array of microneedle”, however it appears it should read --an array of the microneedle-- (emphasis added).
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:
Claim 9: The claim limitation “data processing unit configured to process data …” 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 “unit” coupled with functional language “configured to process data …” 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 “unit”.
Claim 14: The claim limitation “electronics unit configured to wirelessly output data …” 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 “unit” coupled with functional language “configured to wirelessly output data …” 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 “unit”.
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:
“data processing unit can include a processor … memory … central processing unit or a microcontroller unit …” and “programmable processor, a computer, or multiple processors or computers …”, or equivalents thereof, as described in para. [0055] and [00123] of the disclosure filed on 08/16/2024.
“electronics unit … output unit can include a wireless communications unit that includes a wireless transmitter or transceiver device …”, or equivalents thereof, as described in para. [0054-0055] of the disclosure filed on 08/16/2024.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, lines 5-6 recite “the at least one electrochemical sensor electrode”. However, claim 1 recites “an electrochemical sensor electrode”. In light of the specification, it is currently unclear if claim 5 is further defining “an electrochemical sensor electrode” as being “at least one”, if claim 5 is further defining each microneedle of the at least one microneedle include an electrochemical sensor electrode. For the purposes of examination, “the at least one electrochemical sensor electrode” is being interpreted as any electrochemical sensor electrode.
The dependent claims of the above rejected claim are rejected due to their dependency.
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 1-10, 12-16, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tachi et al. (“Monitoring free flap venous congestion using continuous tissue glucose monitoring: A case report”), hereinafter referred to as Tachi, in view of Pushpala et al. (US 20150257687 A1), hereinafter referred to as Pushpala, in view of Lash et al. (US 11179074 B1), hereinafter referred to as Lash.
The claims are generally directed towards a method for assessing tissue viability during a tissue transplantation, the method comprising: attaching a wearable sensor device comprising at least one microneedle having an electrochemical sensor electrode to detect an electrical signal from a reaction with a target analyte in a biofluid exposed to the at least one microneedle, wherein the wearable sensor device is attached to a tissue of an anatomic structure of a subject at an outer surface of the anatomic structure while at a first body location of the subject; measuring a first intradermal concentration of at least one metabolite from the tissue at the first body location of the subject; and detaching at least a portion of the anatomic structure that includes the tissue with the attached wearable sensor device, thereby forming a detached body part with the wearable sensor device attached to the outer surface of the detached body part; attaching the detached body part at a second body location of the subject; and measuring a second intradermal concentration of the at least one metabolite from the tissue at the second body location of the subject.
Regarding claim 1, Tachi discloses a method for assessing tissue viability during a tissue transplantation (Abstract, Introduction), the method comprising:
attaching a wearable sensor device having an electrochemical sensor electrode to detect an electrical signal from a reaction with a target analyte in a biofluid (Fig. 1, Introduction, “continuous tissue glucose monitoring device …”, Case Report, “CTGMD was applied to the flap … TGLs were continuous monitored …”),
attaching the detached body part at a second body location of the subject (Case Report, “superficial inferior epigastric artery perforator flap was performed …”); and
measuring a second intradermal concentration of the at least one metabolite from the tissue at the second body location of the subject (Fig. 1, Introduction, “continuous tissue glucose monitoring device …”, Case Report, “CTGMD was applied to the flap … TGLs were continuous monitored …”).
However, Tachi does not explicitly disclose the wearable sensor device comprises at least one microneedle, and the target analyte in the biofluid is exposed to the at least one microneedle.
Pushpala teaches an analogous wearable sensor device to detect an electrical signal from a reaction with a target analyte in a biofluid (Abstract, Fig. 1, Fig. 2A, para. [0029]). Pushpala further taches the wearable sensor device comprises at least one microneedle, and the target analyte in the biofluid is exposed to the at least one microneedle (para. [0035]). 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 wearable sensor device disclosed by Tachi to additionally comprise at least one microneedle, and the target analyte in the biofluid is exposed to the at least one microneedle, as taught by Pushpala. One of ordinary skill in the art would recognize utilizing a microneedle wearable sensor device is a simple substitution of a known monitoring device for another to obtain the predictable results of invasive analyte measurements of a biofluid.
However, modified Tachi does not explicitly disclose wherein the wearable sensor device is attached to a tissue of an anatomic structure of a subject at an outer surface of the anatomic structure while at a first body location of the subject; measuring a first intradermal concentration of at least one metabolite from the tissue at the first body location of the subject; and detaching at least a portion of the anatomic structure that includes the tissue with the attached wearable sensor device, thereby forming a detached body part with the wearable sensor device attached to the outer surface of the detached body part.
Lash teaches an analogous method for assessing tissue viability during a tissue transplantation (Abstract, col. 2, lines 14-21, col. 19, lines 28-41). Lash further teaches the wearable sensor device is attached to a tissue of an anatomic structure of a subject at an outer surface of the anatomic structure while at a first body location of the subject; measuring a first intradermal concentration of at least one metabolite from the tissue at the first body location of the subject; and detaching at least a portion of the anatomic structure that includes the tissue with the attached wearable sensor device, thereby forming a detached body part with the wearable sensor device attached to the outer surface of the detached body part (col. 19, lines 28-41). 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 Tachi to additionally attach the wearable sensor device to the tissue at a first body location, measure a first intradermal concentration at the first body location, and detach the tissue with the attached wearable sensor device, as taught by Lash. This is because Lash teaches monitoring a flap at various stages, including at its original site, after lifting the tissue, during attachment, and during recovery, allows for a surgeon to determine if a flap is successfully transferred throughout the entire procedure, allowing remedial measures to be taken (col. 19, lines 28-41).
Regarding claim 2, modified Tachi discloses the method of claim 1, wherein measurements of the first and the second intradermal concentrations are measured continuously during when the tissue is at the first body location and during when the tissue is attached to the second body location (Case Report, “continuously monitored …”, - further, see the rejection of claim 1 regarding the first body location and the second body location).
Regarding claim 3, modified Tachi discloses the method of claim 1.
However, modified Tachi does not explicitly disclose the method further comprises: measuring a third intradermal concentration of the at least one metabolite from the tissue between the detaching the at least a portion of the anatomic structure from the first body location of the subject and the attaching the detached body part at the second body location of the subject.
Lash further teaches measuring a third measurement from the tissue between the detaching the at least a portion of the anatomic structure from the first body location of the subject and the attaching the detached body part at the second body location of the subject (col. 19, lines 28-41). 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 Tachi to additionally measure a third intradermal concentration from the tissue between the detaching the at least a portion of the anatomic structure from the first body location of the subject and the attaching the detached body part at the second body location of the subject, as taught by Lash. This is because Lash teaches monitoring a flap at various stages, including at its original site, after lifting the tissue, during attachment, and during recovery, allows for a surgeon to determine if a flap is successfully transferred throughout the entire procedure, allowing remedial measures to be taken (col. 19, lines 28-41).
Regarding claim 4, modified Tachi discloses the method of claim 3, wherein measurements of the first, the second, and the third intradermal concentrations are measured continuously during the detaching of the at least a portion of the anatomic structure from the first body location of the subject and the attaching of the detached body part at the second body location of the subject (Case Report, “continuously monitored …”, - further, see the rejection of claim 1 and claim 3 regarding the body locations).
Regarding claim 5, modified Tachi discloses the method of claim 1.
However, modified Tachi does not explicitly disclose wherein the wearable sensor device comprises: a substrate comprising an electrically insulative material, the at least one microneedle disposed on the substrate and comprising a body region and a tip region, and a chemical layer on the tip region of the at least one microneedle configured to interact with the target analyte in the biofluid and produce the electrical signal at the at least one electrochemical sensor electrode.
Pushpala further teaches the wearable sensor device comprises a substrate comprising an electrically insulative material, the at least one microneedle disposed on the substrate and comprising a body region and a tip region, and a chemical layer on the tip region of the at least one microneedle configured to interact with the target analyte in the biofluid and produce the electrical signal at the at least one electrochemical sensor electrode (Fig. 2A, Figs. 3, para. [0035-0042]). 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 wearable sensor device taught by modified Tachi to additionally include a substrate comprising an electrically insulative material, and the at least one microneedle disposed on the substrate and comprising a body region and a tip region, and a chemical layer on the tip region, as taught by Pushpala. One of ordinary skill in the art would recognize utilizing a microneedle with an insulative substrate, and tip region with a chemical layer is a simple substitution of a known monitoring device for another to obtain the predictable results of invasive analyte measurements of a biofluid.
Regarding claim 6, modified Tachi discloses the method of claim 5.
However, modified Tachi does not explicitly disclose wherein the at least one microneedle is a hollow microneedle structure, or wherein the at least one microneedle is a solid microneedle structure.
Pushpala further teaches the at least one microneedle is a hollow microneedle structure, or wherein the at least one microneedle is a solid microneedle structure (Figs. 3, para. [0042]). 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 at least one microneedle taught by modified Tachi to additionally be a hollow microneedle structure or a solid microneedle structure, as taught by Pushpala. This is because Pushpala teaches hollow or solid microneedle structures are suitable structures for facilitating detection of an analyte (para. [0042]).
Regarding claim 7, modified Tachi discloses the method of claim 1.
However, modified Tachi does not explicitly disclose wherein the wearable sensor device comprises an array of microneedles comprising a plurality of the at least one microneedle.
Pushpala further teaches the wearable sensor device comprises an array of microneedles comprising a plurality of the at least one microneedle (Fig. 2B, para. [0035-0042]). 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 wearable sensor device taught by modified Tachi to additionally include an array of microneedles comprising a plurality of the at least one microneedle, as taught by Pushpala. This is because Pushpala teaches an array of microneedles allows for trends in values to be determined, and for multiple analytes to be determined with a single sensor device (para. [0037]).
Regarding claim 8, modified Tachi discloses the method of claim 7.
However, modified Tachi does not explicitly disclose wherein the plurality of the at least one microneedle are distributed in multiple regions of the tissue, and wherein the method further comprises: analyzing the first intradermal concentration and the second intradermal concentration measured from the plurality of the at least one microneedle to produce a spatial-temporal map of viability of the tissue across the multiple regions of the tissue and over a period of time.
Pushpala further teaches the at least one microneedle is distributed in multiple regions of the tissue (Fig. 2B, para. [0038]). Pushpala further teaches analyzing the first intradermal concentration and the second intradermal concentration measured from the plurality of the at least one microneedle to produce a spatial-temporal map of viability of the tissue across the multiple regions of the tissue and over a period of time (para. [0037], para. [0075], para. [0077]). 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 Tachi to additionally include microneedles in multiple regions of the tissue, and analyze the concentrations to produce a spatial-temporal map over a period of time, as taught by Pushpala. This is because Pushpala teaches monitoring trends in analyte measurements from a plurality of microneedles allows for alerts to be made based on the trends (para. [0075], para. [0077]).
Regarding claim 9, Tachi discloses a method for assessing tissue viability during a tissue transplantation (Abstract, Introduction), the method comprising:
obtaining, from a wearable sensor device exposed to a biofluid in a tissue of a subject while the tissue is at a second body location of the subject, a second dataset comprising at least one intradermal concentration of the one or more analytes from the tissue at the second body location of the subject, wherein, prior to obtaining the second data set (Fig. 1, Introduction, “continuous tissue glucose monitoring device …”, Case Report, “CTGMD was applied to the flap … TGLs were continuous monitored …”), the tissue was detached from the first body location and transplanted at the second body location of the subject (Case Report, “superficial inferior epigastric artery perforator flap was performed …”); and
However, Tachi does not explicitly disclose obtaining, from the wearable sensor device exposed to the biofluid in the tissue of the subject while the tissue is at a first body location of the subject, a first dataset comprising at least one intradermal concentration of one or more analytes from the tissue at the first body location of the subject.
Lash teaches an analogous method for assessing tissue viability during a tissue transplantation (Abstract, col. 2, lines 14-21, col. 19, lines 28-41). Lash further teaches obtaining, from the wearable sensor device exposed to the biofluid in the tissue of the subject while the tissue is at a first body location of the subject, a first dataset comprising at least one intradermal concentration of one or more analytes from the tissue at the first body location of the subject (col. 19, lines 28-41). 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 Tachi to additionally obtain, from the wearable sensor device exposed to the biofluid in the tissue of the subject while the tissue is at a first body location of the subject, a first dataset comprising at least one intradermal concentration of one or more analytes from the tissue at the first body location of the subject, as taught by Lash. This is because Lash teaches monitoring a flap at various stages, including at its original site, after lifting the tissue, during attachment, and during recovery, allows for a surgeon to determine if a flap is successfully transferred throughout the entire procedure, allowing remedial measures to be taken (col. 19, lines 28-41).
However, modified Tachi does not explicitly disclose comparing, by a data processing unit configured to process data obtained from the wearable sensor device, the first dataset to the second dataset, wherein the comparing includes correlating temporal information in the first dataset and the second dataset to temporal stages of the tissue transplantation, wherein the at least one intradermal concentration of the one or more analytes at the first body location of the subject and the at least one intradermal concentration of the one or more analytes at the second body location of the subject are measured by one or more microneedle electrochemical sensor electrodes of the wearable sensor device.
Pushpala teaches an analogous wearable sensor device to detect an electrical signal from a reaction with a target analyte in a biofluid (Abstract, Fig. 1, Fig. 2A, para. [0029]). Pushpala further teaches comparing, by a data processing unit configured to process data obtained from the wearable sensor device, the first dataset to the second dataset, wherein the comparing includes correlating temporal information in the first dataset and the second dataset to temporal stages of the tissue transplantation (para. [0037], para. [0075], para. [0077]). Pushpala further teaches wherein the at least one intradermal concentration of the one or more analytes at the first body location of the subject and the at least one intradermal concentration of the one or more analytes at the second body location of the subject are measured by one or more microneedle electrochemical sensor electrodes of the wearable sensor device (para. [0035]). 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 Tachi to additionally compare the first dataset and the second dataset, and to additionally utilize microneedles, as taught by Pushpala. This is because Pushpala teaches Pushpala teaches monitoring trends in analyte measurements from a plurality of microneedles allows for alerts to be made based on the trends (para. [0075], para. [0077]), and utilizing a microneedle wearable sensor device is a simple substitution of a known monitoring device for another to obtain the predictable results of invasive analyte measurements of a biofluid.
Regarding claim 10, modified Tachi discloses the method of claim 9, wherein the one or more analytes include at least one of pyruvate, glucose, or lactate (Fig. 1, Introduction, “continuous tissue glucose monitoring device …”, Case Report, “CTGMD was applied to the flap … TGLs were continuous monitored …”).
Regarding claim 12, modified Tachi discloses the method of claim 9.
However, modified Tachi does not explicitly disclose wherein the one or more microneedle electrochemical sensor electrodes include a hollow microneedle structure, or wherein one or more microneedle electrochemical sensor electrodes include a solid microneedle structure.
Pushpala further teaches the one or more microneedle electrochemical sensor electrodes include a hollow microneedle structure, or wherein one or more microneedle electrochemical sensor electrodes include a solid microneedle structure (Figs. 3, para. [0042]). 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 at least one microneedle taught by modified Tachi to additionally be a hollow microneedle structure or a solid microneedle structure, as taught by Pushpala. This is because Pushpala teaches hollow or solid microneedle structures are suitable structures for facilitating detection of an analyte (para. [0042]).
Regarding claim 13, modified Tachi discloses the method of claim 9.
However, modified Tachi does not explicitly disclose wherein at least one of the one or more microneedle electrochemical sensor electrodes comprises a chemical layer deposited on a tip region of an electrode surface or coated on an outer wall of a microneedle surface, wherein the chemical layer is configured to chemically react with an analyte of the one or more analytes thereby facilitating electrochemical detection of a reaction involving the chemical layer and the analyte.
Pushpala further teaches the wearable sensor device comprises a chemical layer deposited on a tip region of an electrode surface or coated on an outer wall of a microneedle surface, wherein the chemical layer is configured to chemically react with an analyte of the one or more analytes thereby facilitating electrochemical detection of a reaction involving the chemical layer and the analyte (Fig. 2A, Figs. 3, para. [0035-0042]). 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 wearable sensor device taught by modified Tachi to additionally include a chemical layer deposited on a tip region of an electrode surface or coated on an outer wall of a microneedle surface, wherein the chemical layer is configured to chemically react with an analyte of the one or more analytes thereby facilitating electrochemical detection of a reaction involving the chemical layer and the analyte, as taught by Pushpala. One of ordinary skill in the art would recognize utilizing a microneedle with chemical layer deposited on a tip region of an electrode surface or coated on an outer wall of a microneedle surface, wherein the chemical layer is configured to chemically react with an analyte of the one or more analytes thereby facilitating electrochemical detection of a reaction involving the chemical layer and the analyte is a simple substitution of a known monitoring device for another to obtain the predictable results of invasive analyte measurements of a biofluid.
Regarding claim 14, modified Tachi discloses the method of claim 9.
However, modified Tachi does not explicitly disclose wherein the wearable sensor device includes an electronics unit configured to wirelessly output data corresponding measurements of the at least one intradermal concentration measured by one or more microneedle electrochemical sensor electrodes of the wearable sensor device to the data processing unit configured on a remote computing device.
Pushpala further teaches wherein the wearable sensor device includes an electronics unit configured to wirelessly output data corresponding measurements of the at least one intradermal concentration measured by one or more microneedle electrochemical sensor electrodes of the wearable sensor device to the data processing unit configured on a remote computing device (Fig. 4, para. [0060-0066], para. [0073-0083]). 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 wearable sensor device taught by modified Tachi to additionally include an electronics unit configured to wirelessly output data corresponding measurements of the at least one intradermal concentration measured by one or more microneedle electrochemical sensor electrodes of the wearable sensor device to the data processing unit configured on a remote computing device, as taught by Pushpala. This is because Pushpala teaches a remote computing device allows for analysis to be performed off-board (para. [0060]).
Regarding claim 15, modified Tachi discloses the method of claim 14.
However, modified Tachi does not explicitly disclose wherein the remote computing device includes a smartphone, a tablet, a smart wearable device, a laptop computer, or desktop computer.
Pushpala further teaches the remote computing device includes a smartphone, a tablet, a smart wearable device, a laptop computer, or desktop computer (para. [0033], para. [0073], para. [0077]). 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 remote computing device taught by modified Tachi to explicitly include a smartphone, a tablet, a smart wearable device, a laptop computer, or desktop computer, as taught by Pushpala. This is because Pushpala teaches smartphones, tablets, smart wearable device, laptop computers, and desktop computers are suitable and known computing devices (para. [0033], para. [0073], para. [0077]).
Regarding claim 16, modified Tachi discloses the method of claim 9.
However, modified Tachi does not explicitly disclose the method further comprises: determining a viability of the tissue based at least in part on the comparing the first dataset to the second dataset.
Pushpala further teaches determining a viability of the tissue based at least in part on the comparing the first dataset to the second dataset (para. [0037], para. [0075], para. [0077]). 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 Tachi to additionally determine a viability of the tissue based at least in part on the comparing the first dataset to the second dataset, as taught by Pushpala. This is because Pushpala teaches monitoring trends in analyte measurements allows for alerts to be made based on the trends (para. [0075], para. [0077]).
Regarding claim 19, modified Tachi discloses the method of claim 9, wherein the wearable sensor device is attached subcutaneously to the tissue, and wherein the biofluid is skin interstitial fluid (Fig. 1, Introduction, “continuous tissue glucose monitoring device …”, Case Report, “CTGMD was applied to the flap … TGLs were continuous monitored …”).
Regarding claim 20, modified Tachi discloses the method of claim 9.
However, modified Tachi does not explicitly disclose wherein the wearable sensor device comprises an array of microneedle electrochemical sensor electrodes.
Pushpala further teaches the wearable sensor device comprises an array of microneedle electrochemical sensor electrodes (Fig. 2B, para. [0035-0042]). 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 wearable sensor device taught by modified Tachi to additionally include an array of microneedle electrochemical sensor electrodes, as taught by Pushpala. This is because Pushpala teaches an array of microneedles allows for trends in values to be determined, and for multiple analytes to be determined with a single sensor device (para. [0037]).
Regarding claim 21, modified Tachi discloses the method of claim 9.
However, modified Tachi does not explicitly disclose wherein the method comprises implementing a plurality of the wearable sensor devices to obtain the first dataset and the second dataset, where the plurality of the wearable sensor devices are distributed in multiple regions of the tissue, and wherein the method further comprises: analyzing tissue viability at the multiple regions of the tissue based on spatial information associated with the first dataset and the second dataset measured from the plurality of the wearable sensor devices to produce a spatial-temporal map of viability of the tissue across the multiple regions of the tissue and over a period of time.
Pushpala further teaches implementing a plurality of the wearable sensor devices to obtain the first dataset and the second dataset, where the plurality of the wearable sensor devices are distributed in multiple regions of the tissue (para. [0038-0041]). Pushpala further teaches analyzing tissue viability at the multiple regions of the tissue based on spatial information associated with the first dataset and the second dataset measured from the plurality of the wearable sensor devices to produce a spatial-temporal map of viability of the tissue across the multiple regions of the tissue and over a period of time (para. [0037], para. [0075], para. [0077]). 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 Tachi to additionally implement a plurality of the wearable sensor devices, and analyze tissue viability at multiple regions of the tissue based on spatial information to provide a spatial-temporal map over a period of time, as taught by Pushpala. This is because Pushpala teaches monitoring trends in analyte measurements from a plurality of microneedles allows for alerts to be made based on the trends (para. [0075], para. [0077]).
Regarding claim 22, modified Tachi discloses the method of claim 21.
However, modified Tachi does not explicitly disclose wherein at least some of the plurality of wearable sensor devices are attached to a shared substrate.
Pushpala further teaches at least some of the plurality of wearable sensor devices are attached to a shared substrate (Fig. 2, para. [0035-0042]). 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 wearable devices taught by modified Tachi to be attached to a share substrate, as taught by Pushpala. This is because Pushpala teaches a shared substrate with a plurality of devices allows for a plurality of analytes can be measured across a larger area with a single device (para. [0037]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tachi et al. (“Monitoring free flap venous congestion using continuous tissue glucose monitoring: A case report”), hereinafter referred to as Tachi, in view of Pushpala et al. (US 20150257687 A1), hereinafter referred to as Pushpala, in view of Lash et al. (US 11179074 B1), hereinafter referred to as Lash as applied to claim 9 above, and further in view of Kishi et al. (“A simple way to measure glucose and lactate values during free flap head and neck reconstruction surgery”), hereinafter referred to as Kishi.
Regarding claim 11, modified Tachi discloses the method of claim 9.
However, modified Tachi does not explicitly disclose wherein the one or more analytes include a plurality of the analytes comprising pyruvate, glucose, and lactate.
Kishi teaches an analogous method for assessing tissue viability during a tissue transplantation (Introduction, pg. 226.e1-226.e2). Kishi further teaches measuring glucose and lactate values for evaluating flap blood flow (Introduction, pg. 226.e1-226.e2). 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 Tachi to additionally measure a plurality of analytes comprising pyruvate, glucose, and lactate, as taught by Kishi. This is because Kishi teaches measuring glucose and lactate values together allow for a more complete analysis of determining blood flow obstruction of a flap (Discussion, pg. 226e6-226.e8).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tachi et al. (“Monitoring free flap venous congestion using continuous tissue glucose monitoring: A case report”), hereinafter referred to as Tachi, in view of Pushpala et al. (US 20150257687 A1), hereinafter referred to as Pushpala, in view of Lash et al. (US 11179074 B1), hereinafter referred to as Lash as applied to claim 9 above, and further in view of Kiuchi et al. (“Flap monitoring using interstitial fluid glucose measurements”), hereinafter referred to as Kiuchi.
Regarding claim 17, modified Tachi discloses the method of claim 9.
However, modified Tachi does not explicitly disclose determining a viability of the tissue based at least in part on calculating a signal difference between (i) a first set of measurements obtained at a first time or time period from the wearable sensor device at the first body location and the second body location and (ii) a second set of measurements obtained at a second time or time period from another wearable sensor device attached to another, non-transplanted tissue of the subject at a third body location of the subject, wherein the first set of measurements and the second set of measurements indicate concentrations of the one or more analytes.
Kiuchi teaches an analogous method for assessing tissue viability during a tissue transplantation (Abstract, Introduction). Kiuchi further teaches determining a viability of the tissue based at least in part on calculating a signal difference between (i) a first set of measurements obtained at a first time or time period from the wearable sensor device at the first body location and the second body location and (ii) a second set of measurements obtained at a second time or time period from another wearable sensor device attached to another, non-transplanted tissue of the subject at a third body location of the subject, wherein the first set of measurements and the second set of measurements indicate concentrations of the one or more analytes (Abstract, Materials and Methods, “two sensors of IFG measuring instruments were attached … unaffected breast utilized as the site for control IFG measurements … Flap IFG, control IFG, and IFG ratio …”). 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 Tachi to additionally determining a viability of the tissue based at least in part on calculating a signal difference between (i) a first set of measurements obtained at a first time or time period from the wearable sensor device at the first body location and the second body location and (ii) a second set of measurements obtained at a second time or time period from another wearable sensor device attached to another, non-transplanted tissue of the subject at a third body location of the subject, wherein the first set of measurements and the second set of measurements indicate concentrations of the one or more analytes, as taught by Kiuchi. This is because Kiuchi teaches comparing a flap IFG and a control IFG allows for a baseline to be determined specific to the patient, which can change due to food intake (Discussion, pg. 303), allowing for more accurate flap IFG results and analysis.
Regarding claim 18, modified Tachi discloses the method of claim 17.
However, modified Tachi does not explicitly disclose the method further comprises: determining statistical significance of the signal difference based on a time difference between the first time and the second time.
Kiuchi further teaches determining statistical significance of the signal difference based on a time difference between the first time and the second time (Discussion, pg. 301-303). 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 Tachi to additionally determine a statistical significance of the signal difference based on a time difference between the first time and the second time, as taught by Kiuchi. This is because Kiuchi teaches analyzing time differences between the first time and the second time allow for a degree of change in glucose of the flap tissue to be determined (Discussion, pg. 301-303).
Conclusion
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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