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 71-78 in the response filed 04/01/2026 is acknowledged.
Claims 1-8, 11, 13-16, 18, 21-23, 28, 30-31, and 86-92 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Invention I, Species A2, Species B1, and Species C1, Claims 1-4, 6, 8, 11, 13-16, 21-23, 28, 30-31, and 86-90, in the reply filed on 04/01/2026 is acknowledged.
Claims 5, 7, 18, 23, and 91-92 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/01/2026. (Examiner's Note: Applicant cancelled claims 71-78 in the response filed 04/01/2026) (Examiner's Note: The applicant indicated that claim 23 is readable on the elected species. However, as indicated in the restriction requirement, filled 02/13/2026, Species C1 was indicated as not including claim 23. The applicant did withdraw claims 91 and 92, which were involved with Species C2 and C3. The applicant did not present arguments as to why claim 23 should not be withdrawn and the election was not made with traverse. As such, claim 23 will also be withdrawn.)
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, 11, 13-16, 21-22, 28, 30-31, and 86-90 are hereby under examination.
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 1: The claim limitation “a substrate configured to couple to the user's skin” 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 “substrate” coupled with functional language “configured to couple to the user's skin” 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 “substrate”.
Claim 1: The claim limitation “the array of microneedles configured to…” “…generate a first electrical signal indicative of at least one analyte in the interstitial fluid within the user's skin” 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 “microneedles” coupled with functional language “configured to…” “…generate a first electrical signal indicative of at least one analyte in the interstitial fluid within the user's skin” 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 “microneedle”.
Claim 1: The claim limitation “a pod configured to releasably couple to the patch” 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 “pod” coupled with functional language “configured to releasably couple to the patch” 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 “a pod”.
Claim 1: The claim limitation “a processor configured to be in electrical communication with the array of microneedles when the pod is releasably coupled to the patch” 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 “processor” coupled with functional language “configured to be in electrical communication with the array of microneedles when the pod is releasably coupled to the patch” 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 “processor”.
Claim 1: The claim limitation “cause the processor to: receive and process the first electrical signal from the array of microneedles to generate a first health measurement for the user, and receive and process the second electrical signal from the at least one sensor to generate a second health measurement for the user” 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 “processor” coupled with functional language “receive and process the first electrical signal from the array of microneedles to generate a first health measurement for the user, and receive and process the second electrical signal from the at least one sensor to generate a second health measurement for the user” 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 “processor”,
Claim 16: The claim limitation “processor to receive and process the third electrical signal to determine penetration of the microneedles into the user's skin” 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 “processor” coupled with functional language “receive and process the third electrical signal to determine penetration of the microneedles into the user's skin” 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 “processor”
Claim 30: The claim limitation “patches are configured to detect different analytes” 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 “patches” coupled with functional language “configured to detect different analytes” 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 “patches”.
Claim 86: The claim limitation “a patch configured to couple to the user's skin” 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 “patch” coupled with functional language “configured to couple to the user's skin” 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 “patch”.
Claim 86: The claim limitation “means for accessing interstitial fluid in the user's skin” 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 “means” coupled with functional language “for accessing interstitial fluid in the user's skin” 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 “means”.
Claim 86: The claim limitation “means for…” “… generating a first electrical signal indicative of at least one analyte in the interstitial fluid” 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 “means” coupled with functional language “for… “…generating a first electrical signal indicative of at least one analyte in the interstitial fluid” 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 “means”.
Claim 86: The claim limitation “a pod configured to releasably couple to the patch” 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 “pod” coupled with functional language “configured to releasably couple to the patch” 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 “pod”.
Claim 86: The claim limitation “means for generating a second electrical signal indicative of at least one physiological parameter of the user” 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 “means” coupled with functional language “for generating a second electrical signal indicative of at least one physiological parameter of the user” 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 “means”.
Claim 86: The claim limitation “processing means for: processing the first electrical signal to generate a first health measurement for the user, and processing the second electrical signal to generate a second health measurement for the user” 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 “processing means” coupled with functional language “processing the first electrical signal to generate a first health measurement for the user, and processing the second electrical signal to generate a second health measurement for the user” 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 “processing means”.
Claim 86: The claim limitation “communication means for transmitting the first and second health measurements to a remote device” 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 “communication means” coupled with functional language “communication means for transmitting the first and second health measurements to a remote device” 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 “communication means”.
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:
A surface with an adhesive, or equivalents thereof, as described on Par. 59 of the disclosure filed on 04/04/2024.
Microneedles with electrodes, or equivalents thereof, as described on Par. 59-60 of the disclosure filed on 04/04/2024.
“interference fit, snap fit, threading, fasteners, bonding, adhesives, and/or suitable combinations thereof.”, “The housing 330 can connect to the pod 304 using any suitable temporary mechanism, such as snap fit, interference fit, threading, fasteners, etc. For example, the inner surface of the housing 330 can include a set of ridges 338 configured to mate with a corresponding groove 340 formed in the periphery of the pod 304 (FIG. 3B) via snap fit.”, or equivalents thereof, as described on Par. 62 and Par. 87 of the disclosure filed on 04/04/2024.
“The processor(s) 376 can be or include any number of microcontrollers, microprocessors, or other suitable components for performing and/or controlling various operations, such as any of the following: receiving and processing signals generated by the microneedle arrays 306a-c and/or other sensors of the device 300…”, or equivalents thereof, as described on Par. 103 of the disclosure filed on 04/04/2024.
A processor with an algorithm, or equivalents thereof, as described on Par. 64, 69-71, and 103 of the disclosure filed on 04/04/2024, which lacks sufficient detail regarding the structure of the algorithm that performs the indicated function.
A processor with instructions for receiving bioimpedance measurements, or equivalents thereof, as described on Par. 79 and 103 of the disclosure filed on 04/04/2024.
Patches with differing sensors that detect different analytes, or equivalents thereof, as described on Par. 59-60, 63, 68, and 70 of the disclosure filed on 04/04/2024.
A surface with an adhesive, or equivalents thereof, as described on Par. 59 of the disclosure filed on 04/04/2024.
Microneedles with electrodes, or equivalents thereof, as described on Par. 59-60 of the disclosure filed on 04/04/2024.
Microneedles with electrodes, or equivalents thereof, as described on Par. 59-60 of the disclosure filed on 04/04/2024.
“interference fit, snap fit, threading, fasteners, bonding, adhesives, and/or suitable combinations thereof.”, “The housing 330 can connect to the pod 304 using any suitable temporary mechanism, such as snap fit, interference fit, threading, fasteners, etc. For example, the inner surface of the housing 330 can include a set of ridges 338 configured to mate with a corresponding groove 340 formed in the periphery of the pod 304 (FIG. 3B) via snap fit.” or equivalents thereof, as described on Par. 62 and Par. 87 of the disclosure filed on 04/04/2024.
“The sensor(s) 222 can include any suitable combination of sensors for monitoring various health parameters, such as an optical sensor (e.g., photoplethysmography (PPG) sensor, pulse oximeter), heart rate sensor, blood pressure sensor, electrocardiogram (ECG) sensor, activity or motion sensor (e.g., accelerometer, gyroscope), temperature sensor (e.g., thermistor), location sensor, humidity sensor, etc.”, or equivalents thereof, as described on Par. 66 of the disclosure filed on 04/04/2024.
A processor with an algorithm, or equivalents thereof, as described on Par. 64, 69-71 of the disclosure filed on 04/04/2024, which lacks sufficient detail regarding the structure of the algorithm that performs the indicated function.
“The processor(s) 376 can be or include any number of microcontrollers, microprocessors, or other suitable components for performing and/or controlling various operations, such as any of the following: receiving and processing signals generated by the microneedle arrays 306a-c and/or other sensors of the device 300…”, or equivalents thereof, as described on Par. 103 of the disclosure filed on 04/04/2024.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-4, 6, 8, 11, 13-16, 21-22, 28, 30-31, and 86-90 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “a memory operably coupled to the processor and storing instructions that, when executed by the processor, cause the processor to: receive and process the first electrical signal from the array of microneedles to generate a first health measurement for the user, and receive and process the second electrical signal from the at least one sensor to generate a second health measurement for the user”, where the applicant’s specification lacks sufficient detail in regards to the structure of the algorithm that generates first health measurements and second health measurements. The applicant’s specification does state “The memory 216 can also store operating parameters for the device 200, such as calibration parameters, signal processing parameters, algorithms or programs (e.g., for generating health measurements, predictions, etc.), and so on…” (Par. 64 of applicant’s spec.), “Each sensor can generate a respective set of signals, which can be received and processed by the processor 214 to generate health measurements” (Par. 67 of applicant’s spec.), “algorithms can be stored locally at the electronics assembly 212 (e.g., in the memory 216) such that the device 200 can operate without being in communication with a separate computing device or system (e.g., a cloud computing network, remote server, user device, etc.)…” (Par. 69 of applicant’s spec.), “The processor 214 can access and read the identifier information, and can then adjust the parameters and/or algorithms used to process the electrical signals generated by the patch 202…” (Par. 70 of applicant’s spec.), and “the processor 214 can retrieve the appropriate algorithms…” (Par. 71 of applicant’s spec.), however, these merely indicate the presence of an algorithm rather than the structure of the algorithm itself that performs the indicated functions. How are the first and second health measurements generated? What specific processing occurs that generates the health measurements? As such, the applicant’s specification lacks sufficient detail in regards to the structure of the algorithm that performs the indicated functions. As such, the claim is rejected.
Claim 86 recites the limitation “processing means for: processing the first electrical signal to generate a first health measurement for the user, and processing the second electrical signal to generate a second health measurement for the user;”, where the applicant’s specification lacks sufficient detail in regards to the structure of the algorithm that generates first health measurements and second health measurements. The applicant’s specification does state “The memory 216 can also store operating parameters for the device 200, such as calibration parameters, signal processing parameters, algorithms or programs (e.g., for generating health measurements, predictions, etc.), and so on…” (Par. 64 of applicant’s spec.), “Each sensor can generate a respective set of signals, which can be received and processed by the processor 214 to generate health measurements” (Par. 67 of applicant’s spec.), “algorithms can be stored locally at the electronics assembly 212 (e.g., in the memory 216) such that the device 200 can operate without being in communication with a separate computing device or system (e.g., a cloud computing network, remote server, user device, etc.)…” (Par. 69 of applicant’s spec.), “The processor 214 can access and read the identifier information, and can then adjust the parameters and/or algorithms used to process the electrical signals generated by the patch 202…” (Par. 70 of applicant’s spec.), and “the processor 214 can retrieve the appropriate algorithms…” (Par. 71 of applicant’s spec.), however, these merely indicate the presence of an algorithm rather than the structure of the algorithm itself that performs the indicated functions. How are the first and second health measurements generated? What specific processing occurs that generates the health measurements? As such, the applicant’s specification lacks sufficient detail in regards to the structure of the algorithm that performs the indicated functions. As such, the claim is rejected.
Claims 2-4, 6, 8, 11, 13-16, 21-22, 28, and 30-31 are dependent on claim 1, and as such are also rejected.
Claims 87-90 are dependent on claim 86, and as such are also rejected.
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 1-4, 6, 8, 11, 13-16, 21-22, 28, 30-31, and 86-90 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 1 limitation “cause the processor to: receive and process the first electrical signal from the array of microneedles to generate a first health measurement for the user, and receive and process the second electrical signal from the at least one sensor to generate a second health measurement for the user” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The applicant’s specification does state “The memory 216 can also store operating parameters for the device 200, such as calibration parameters, signal processing parameters, algorithms or programs (e.g., for generating health measurements, predictions, etc.), and so on…” (Par. 64 of applicant’s spec.), “Each sensor can generate a respective set of signals, which can be received and processed by the processor 214 to generate health measurements” (Par. 67 of applicant’s spec.), “algorithms can be stored locally at the electronics assembly 212 (e.g., in the memory 216) such that the device 200 can operate without being in communication with a separate computing device or system (e.g., a cloud computing network, remote server, user device, etc.)…” (Par. 69 of applicant’s spec.), “The processor 214 can access and read the identifier information, and can then adjust the parameters and/or algorithms used to process the electrical signals generated by the patch 202…” (Par. 70 of applicant’s spec.), and “the processor 214 can retrieve the appropriate algorithms…” (Par. 71 of applicant’s spec.), however, these merely indicate the presence of an algorithm rather than the structure of the algorithm itself that performs the indicated functions. How are the first and second health measurements generated? What specific processing occurs that generates the health measurements? 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 any generic algorithm capable of the indicated function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim 86 limitation “processing means for: processing the first electrical signal to generate a first health measurement for the user, and processing the second electrical signal to generate a second health measurement for the user;” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The applicant’s specification does state “The memory 216 can also store operating parameters for the device 200, such as calibration parameters, signal processing parameters, algorithms or programs (e.g., for generating health measurements, predictions, etc.), and so on…” (Par. 64 of applicant’s spec.), “Each sensor can generate a respective set of signals, which can be received and processed by the processor 214 to generate health measurements” (Par. 67 of applicant’s spec.), “algorithms can be stored locally at the electronics assembly 212 (e.g., in the memory 216) such that the device 200 can operate without being in communication with a separate computing device or system (e.g., a cloud computing network, remote server, user device, etc.)…” (Par. 69 of applicant’s spec.), “The processor 214 can access and read the identifier information, and can then adjust the parameters and/or algorithms used to process the electrical signals generated by the patch 202…” (Par. 70 of applicant’s spec.), and “the processor 214 can retrieve the appropriate algorithms…” (Par. 71 of applicant’s spec.), however, these merely indicate the presence of an algorithm rather than the structure of the algorithm itself that performs the indicated functions. How are the first and second health measurements generated? What specific processing occurs that generates the health measurements? 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 any generic algorithm capable of the indicated function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-4, 6, 8, 11, 13-16, 21-22, 28, and 30-31 are dependent on claim 1, and as such are also rejected.
Claims 87-90 are dependent on claim 86, and as such are also 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 claims are generally directed towards a device for monitoring the health of a use. The device comprises a patch with a substrate and an array of microneedles that generate an electrical signal indicative of an analyte. The device comprises a pod configured to releasably couple to the patch with at least one sensor, a memory coupled to a processor with instructions to receive and process the signals from the sensor and microneedles, and a communication unit that transmits the results to a remote device.
Claim(s) 1-4, 6, 8, 11, 13-15, 21-22, 28, 30-31, and 86-90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho (US Pub. No. 20160278672) hereinafter Cho, and further in view of Newberry (US Pub. No. 20190076601) hereinafter Newberry.
Regarding claim 1, Cho discloses A device for monitoring a user's health (Par. 102, Fig. 1, wearable device 100), the device comprising:
a patch (Fig. 2, Pad – 104) (Par. 104, “The main body 101 includes a pad 104 on the rear surface of the main body 101 for placement on the user's body.”) comprising:
a substrate configured to couple to the user's skin (Par. 105, “The pad 104 has an adhesive to allow the main body 101 to be worn on the user's body.”) (Examiner's Note: Interpreted under 112f as indicated above); and
an array of microneedles carried by the substrate (Fig. 4, (microneedles – 151 are observably carried by pad 104)) (Fig. 5, (microneedles 151 and sensor unit 105 on pad 104)), the array of microneedles configured to access interstitial fluid in the user's skin and generate a first electrical signal indicative of at least one analyte in the interstitial fluid within the user's skin (Par. 107, “…micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105.”) (Par. 108, “micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid. The conductive-polymer micro needles 151 receive an electric current to trigger a chemical action between the enzyme and the biomarker. The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current…” (electrical signal));
a pod configured to releasably couple to the patch (Par. 14, (sensor unit 105 is detachably coupled to the body unit)), the pod comprising:
a processor configured to be in electrical communication with the array of microneedles when the pod is releasably coupled to the patch (Par. 124, “The circuit unit 106 includes various electronic parts 161, such as a main chipset, communication module, power supplying unit, and storage unit, mounted thereon. The main chipset receives an electrical signal for a biomarker measured by the sensor unit 105.”) (Par. 110, “The circuit unit is electrically connected with the sensor unit 105 to receive a bio signal value measured by the sensor unit 105. The circuit unit includes a communication module to transmit the bio signal value to a separate electronic device 10. The communication module receives data from the separate electronic device 10, which stores the bio signal value received from the communication module or stores bio information analyzed via a separate algorithm or calculation using the bio signal value.”) (Par. 108, “According to an embodiment of the present disclosure, the micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid....”);
a memory operably coupled to the processor and storing instructions that, when executed by the processor (Par. 110, “The circuit unit is electrically connected with the sensor unit 105 to receive a bio signal value measured by the sensor unit 105. The circuit unit includes a communication module to transmit the bio signal value to a separate electronic device 10. The communication module receives data from the separate electronic device 10, which stores the bio signal value received from the communication module or stores bio information analyzed via a separate algorithm or calculation using the bio signal value.”) (Par. 124, “The circuit unit 106 includes various electronic parts 161, such as a main chipset, communication module, power supplying unit, and storage unit, mounted thereon. The main chipset receives an electrical signal for a biomarker measured by the sensor unit 105.”), cause the processor to:
receive and process the first electrical signal from the array of microneedles to generate a first health measurement for the user (Par. 107, “The sensor unit 105 contacts the body to detect a biomarker or to measure an electrical signal by the biomarker. Hereinafter, the electrical signal is referred to as a bio signal...”) (Par. 110, “The circuit unit is electrically connected with the sensor unit 105 to receive a bio signal value measured by the sensor unit 105...”) (Par. 108, “the micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid. The conductive-polymer micro needles 151 receive an electric current to trigger a chemical action between the enzyme and the biomarker. The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current.”), and
a communication unit configured to transmit the first health measurements to a remote device (Par. 124, “The circuit unit 106 includes various electronic parts 161, such as a main chipset, communication module, power supplying unit, and storage unit, mounted thereon. The main chipset receives an electrical signal for a biomarker measured by the sensor unit 105. The sensor unit 105 controls various electronic parts including the communication module, power supplying unit, and storage unit. The communication module communicates bio signals by the biomarker or communicate values by the bio signals…”) (Par. 239, “FIG. 76 illustrates a network environment where a wearable electronic device operates according to an embodiment of the present disclosure.”) (Par. 255, “The communication interface 911 establishes communication between the electronic device 901 and an external electronic device…”).
Cho fails to explicitly disclose at least one sensor configured to extend through a through-hole in the patch and toward a portion of the user's tissue, wherein the at least one sensor is configured to analyze the portion of the tissue to generate a second electrical signal indicative of a physiological parameter of the user.
Cho does disclose microneedles extending beyond the rear surface of the body (Fig. 4 (observable that microneedles 151 extend below pad -104))(Par. 115, “The receiving unit is provided in the third main body 113 to provide a space where the sensor unit 105 is received. The sensor unit 105 may be mounted or separated from a space opened to the front of the third main body 113 to the receiving unit. The receiving unit includes an opening where a unit of the rear surface of the sensor unit, such as where the micro needles 151 are arranged, is exposed to the outside of the third main body 113 and a seating unit 113a where another unit of the rear surface of the sensor unit 105, such as an edge of the sensor unit 105, is seated.”) (Par. 114, “The sensor unit 105 may be mounted or separated from a space opened to the front of the third main body 113 to the receiving unit”).
However, Cho does teach in an alternate embodiment a plurality of different sensors (Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”).
Newberry teaches at least one sensor configured to extend through a through-hole in the patch and toward a portion of the user's tissue (Par. 62, “The needles 106 are configured to pierce at least the upper epidermis of skin of a patient (human or animal) to administer medication to the patient.”) (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”), wherein the at least one sensor is configured to analyze the portion of the tissue to generate a second electrical signal indicative of a physiological parameter of the user (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”).
Newberry and Cho are considered to be analogous art to the claimed invention as they are involved with biological sensing devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho with that of Cho and Newberry to include at least one sensor configured to extend through a through-hole in the patch and toward a portion of the user's tissue, wherein the at least one sensor is configured to analyze the portion of the tissue to generate a second electrical signal indicative of a physiological parameter of the user through the combination of references and addition of a sensor as the use of multiple sensors and detection of multiple analytes is known (Cho (Par. 152, 153, 146))), it would have yielded the predictable result of tracking additional biomarkers (Cho (Par. 153)), and as it would have yielded the predictable result of monitoring patient vitals over time and track medication in the bloodstream of a patient (Newberry (Par. 66)).
Cho fails to explicitly disclose receive and process the second electrical signal from the at least one sensor to generate a second health measurement for the user; and a communication unit configured to transmit the first and second health measurements to a remote device.
Cho does disclose receive and process the electrical signal to generate a health measurement for the user (Par. 107, “The sensor unit 105 contacts the body to detect a biomarker or to measure an electrical signal by the biomarker. Hereinafter, the electrical signal is referred to as a bio signal...”) (Par. 110, “The circuit unit is electrically connected with the sensor unit 105 to receive a bio signal value measured by the sensor unit 105...”) (Par. 108, “the micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid. The conductive-polymer micro needles 151 receive an electric current to trigger a chemical action between the enzyme and the biomarker. The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current.”), and
a communication unit configured to transmit the first health measurement to a remote device (Par. 124, “The circuit unit 106 includes various electronic parts 161, such as a main chipset, communication module, power supplying unit, and storage unit, mounted thereon. The main chipset receives an electrical signal for a biomarker measured by the sensor unit 105. The sensor unit 105 controls various electronic parts including the communication module, power supplying unit, and storage unit. The communication module communicates bio signals by the biomarker or communicate values by the bio signals…”) (Par. 239, “FIG. 76 illustrates a network environment where a wearable electronic device operates according to an embodiment of the present disclosure.”) (Par. 255, “The communication interface 911 establishes communication between the electronic device 901 and an external electronic device…”).
Cho does teach a plurality of measurements from sensors (Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”).
Newberry further teaches second electrical signal from the at least one sensor to generate a second health measurement for the user (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”) and second health measurement (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Cho and Newberry to include receive and process the second electrical signal from the at least one sensor to generate a second health measurement for the user; and a communication unit of Cho configured to transmit the first of Cho and second health measurements to a remote device of Cho through the combination of references and addition of a sensor as the use of multiple sensors and detection of multiple analytes is known (Cho (Par. 152, 153, 146))), it would have yielded the predictable result of tracking additional biomarkers (Cho (Par. 153)) and as it would have yielded the predictable result of monitoring patient vitals over time and track medication in the bloodstream of a patient (Newberry (Par. 65-66)).
Regarding claim 2, modified Cho further discloses wherein the at least one analyte includes one or more of the following: glucose (Cho (Par. 107, “…micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105.”) (Par. 108, “micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid. The conductive-polymer micro needles 151 receive an electric current to trigger a chemical action between the enzyme and the biomarker. The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current…” (electrical signal)) (Par. 109, “The sensor unit 105 measures the concentration of glucose from the collected body fluid. However, the sensor unit 105 is not limited thereto, and detects various biomarkers such as lactic acid in the body fluid or measure a bio signal by the micro needle.”)), lactic acid, alcohol, creatine, potassium, sodium, urea, blood urea nitrogen, ketones, or bicarbonate.
Regarding claim 3, modified Cho further discloses wherein the first health measurement includes a concentration of the at least one analyte (Cho (Par. 107, “…micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105.”) (Par. 108, “micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid. The conductive-polymer micro needles 151 receive an electric current to trigger a chemical action between the enzyme and the biomarker. The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current…” (electrical signal)) (Par. 109, “The sensor unit 105 measures the concentration of glucose from the collected body fluid. However, the sensor unit 105 is not limited thereto, and detects various biomarkers such as lactic acid in the body fluid or measure a bio signal by the micro needle.”)).
Regarding claim 4, modified Cho fails to explicitly disclose the limitations of the claim.
However, Cho does teach in alternate embodiments further wherein the array of microneedles is configured to detect two or more different analytes in the interstitial fluid (Cho (Par. 107, “the sensor unit 105 includes micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105. “)(Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”)(Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Cho to include wherein the array of microneedles is configured to detect two or more different analytes in the interstitial fluid through the combination of embodiments and addition of a sensor as the use of multiple sensors and detection of multiple analytes is known (Cho (Par. 152, 153, 146))), and it would have yielded the predictable result of tracking additional biomarkers (Cho (Par. 153)).
Regarding claim 6, modified Cho fails to explicitly disclose the limitations of the claim.
However, Cho teaches in an embodiment wherein the array of microneedles is a first array of microneedles(Cho (Par. 107, “the sensor unit 105 includes micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105. “)(Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”)), and the at least one analyte is a first analyte (Cho (Par. 153, sensor unit 105a)), and the patch further comprises a second array of microneedles configured to detect a second, different analyte (Cho (Par. 107, “the sensor unit 105 includes micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105. “) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments” (sensor unit 105b)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Cho to include wherein the array of microneedles is a first array of microneedles, and the at least one analyte is a first analyte, and the patch further comprises a second array of microneedles configured to detect a second, different analyte for the reasoning as indicated in claim 4 above.
Regarding claim 8, modified Cho further discloses wherein the microneedles are configured to access an epidermal layer of the user's skin (Cho (Par. 107, “The sensor unit 105 contacts the body to detect a biomarker or to measure an electrical signal by the biomarker. Hereinafter, the electrical signal is referred to as a bio signal. For example, the sensor unit 105 includes micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105.” (insertion into the skin to collect fluid))).
Regarding claim 11, modified Cho further discloses wherein the substrate includes an adhesive region configured to releasably couple to the user's skin (Cho (Par. 105 “The pad 104 has an adhesive to allow the main body 101 to be worn on the user's body.”) (Fig. 4, (microneedles – 151 are observably carried by pad 104))), and wherein the adhesive region at least partially surrounds the array of microneedles (Cho (Fig. 4, (microneedles – 151 are observably carried by pad 104)) (Fig. 5, (microneedles 151 and sensor unit 105 on pad 104, where the adhesive pad observably surrounds the microneedles)) (Par. 105 “The pad 104 has an adhesive to allow the main body 101 to be worn on the user's body.”)).
Regarding claim 13, modified Cho further discloses wherein: the array of microneedles is coupled to a lower surface of the substrate (Cho (Par. 105 “The pad 104 has an adhesive to allow the main body 101 to be worn on the user's body.”) (Fig. 4, (microneedles – 151 are observably carried by pad 104)), and the patch includes an annular housing on an upper surface of the substrate (Cho (Fig. 8, third main body – 113) (Par. 113, “the wearable electronic device includes a receiving unit for receiving the sensor unit 105 and a cover unit 103 for fastening the sensor unit 105.”)), the annular housing configured to receive and couple to the pod (Cho (Fig. 8, third main body – 113) (Par. 113, “the wearable electronic device includes a receiving unit for receiving the sensor unit 105 and a cover unit 103 for fastening the sensor unit 105.”)) (Par. 114, “The receiving unit is provided in the third main body 113 to provide a space where the sensor unit 105 is received. The sensor unit 105 may be mounted or separated from a space opened to the front of the third main body 113 to the receiving unit…”)).
Regarding claim 14, modified Cho further discloses wherein the patch includes a set of first electrical contacts on an upper surface of the substrate (Cho (Par. 119, “For example, the sensor unit 105 is electrically connected with the circuit unit sequentially passing through the contact pads 153, the contact terminals 135, and the first circuit board 138.”)), the set of first electrical contacts being electrically coupled to the array of microneedles (Cho (Par. 119, “For example, the sensor unit 105 is electrically connected with the circuit unit sequentially passing through the contact pads 153, the contact terminals 135, and the first circuit board 138.”) (Par. 120, “he contact terminals 135 transfer current from the circuit unit to the sensor unit 105 and include an elastic force allowing the contact terminals 135 to be extended or contracted along a longitudinal direction of the contact terminals 135. For example, the contact terminals 135 may be pogo pins. The contact terminals 135, as coupled to the third cover unit 113 with the cover unit 103 covering the receiving unit, may be pressurized abutting the contact pads 153 of the sensor unit 105. As the contact terminals 135 are contracted, the contact terminals 135 remains in contact with the contact pads 153.”)).
Regarding claim 15, modified Cho further discloses wherein:
the pod includes a set of second electrical contacts on a lower surface of the pod (Cho (Par. 125, “The second circuit board 139 is provided between the circuit unit 106 and the battery 107 to supply power from the battery 107 to the circuit unit 106. The second circuit board 139 is connected with the first circuit board 138 to be electrically connected with the sensor unit 105 via the contact terminals connected with the first circuit board 138.”)), the set of second electrical contacts being electrically coupled to the processor (Cho (Par. 123, “the wearable electronic device includes a second circuit board 139 connected with the circuit unit 106.”) (Par. 124, “he circuit unit 106 includes various electronic parts 161, such as a main chipset, communication module, power supplying unit, and storage unit, mounted thereon. The main chipset receives an electrical signal for a biomarker measured by the sensor unit 105.”)); and
when the pod is coupled to the patch, the processor is electrically coupled to the array of microneedles via the first and second electrical contacts (Cho (Par. 123, “the wearable electronic device includes a second circuit board 139 connected with the circuit unit 106.”) (Par. 124, “the circuit unit 106 includes various electronic parts 161, such as a main chipset, communication module, power supplying unit, and storage unit, mounted thereon. The main chipset receives an electrical signal for a biomarker measured by the sensor unit 105.”)(Par. 125, “The second circuit board 139 is provided between the circuit unit 106 and the battery 107 to supply power from the battery 107 to the circuit unit 106. The second circuit board 139 is connected with the first circuit board 138 to be electrically connected with the sensor unit 105 via the contact terminals connected with the first circuit board 138.”)).
Regarding claim 21, modified Cho fails to explicitly disclose the limitations of the claim.
However, Newberry further teaches wherein the at least one sensor includes a photoplethysmography (PPG) sensor, and the physiological parameter includes one or more of an oxygen level or a heart rate of the user (Newberry (Par. 65, “he PPG circuit 110 may be configured to detect SPO.sub.2 levels, heart rate, blood pressure and/or concentration of substances in arterial blood flow of the patient as described in more detail herein…”)(Par. 62, “The needles 106 are configured to pierce at least the upper epidermis of skin of a patient (human or animal) to administer medication to the patient.”) (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”)).
Cho does teach in an alternate embodiment a plurality of different sensors (Cho (Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Newberry to include wherein the at least one sensor includes a photoplethysmography (PPG) sensor, and the physiological parameter includes one or more of an oxygen level or a heart rate of the user through the combination of references and addition of a sensor as the use of multiple sensors and detection of multiple analytes is known (Cho (Par. 152, 153, 146))), it would have yielded the predictable result of tracking additional biomarkers (Cho (Par. 153)), and as it would have yielded the predictable result of monitoring patient vitals over time and track medication in the bloodstream of a patient (Newberry (Par. 66)).
Regarding claim 22, modified Cho fails to explicitly disclose the limitations of the claim.
However, Newberry further teaches the pod includes a protrusion housing the PPG sensor (Newberry (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths”)), and a window in the protrusion forming an optical path to the PPG sensor (Newberry (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”); and
the substrate of the patch includes the through-hole configured to receive the protrusion (Newberry (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Fig. 3-4, (needles 106 protrude from the substrate surface 203)) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”)),
such that when the substrate is coupled to the user's skin, the window of the protrusion is placed in direct contact with the user's skin (Newberry (Par. 65, “he PPG circuit 110 may be configured to detect SPO.sub.2 levels, heart rate, blood pressure and/or concentration of substances in arterial blood flow of the patient as described in more detail herein…”)(Par. 62, “The needles 106 are configured to pierce at least the upper epidermis of skin of a patient (human or animal) to administer medication to the patient.”) (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Newberry to include the pod includes a protrusion housing the PPG sensor, and a window in the protrusion forming an optical path to the PPG sensor; and the substrate of the patch includes the through-hole configured to receive the protrusion, such that when the substrate is coupled to the user's skin, the window of the protrusion is placed in direct contact with the user's skin through the combination of references and addition of a sensor as the use of multiple sensors and detection of multiple analytes is known (Cho (Par. 152, 153, 146))), it would have yielded the predictable result of tracking additional biomarkers (Cho (Par. 153)), and as it would have yielded the predictable result of monitoring patient vitals over time and track medication in the bloodstream of a patient (Newberry (Par. 66)).
Regarding claim 28, modified Cho further discloses wherein the pod is configured to be reusable and the patch is configured to be disposable, and wherein the pod is configured to be sequentially coupled to a plurality of disposable patches (Cho (Par. 12, “Accordingly, an aspect of the present disclosure is to provide a wearable electronic device having some replaceable parts, such as micro needles, and other parts that may be continuously used, such as a battery, detachably coupled with each other.”) (Par. 121, “As such, as the sensor unit 105 is received in the receiving unit and fastened by the cover unit 103 or is removed from the receiving unit as the cover unit 103 rotates, the sensor unit 105 may be replaced from the main body when necessary, while the circuit unit and battery in the main body may be continuously used along with the exchanged sensor unit 105.” (the sensor unit is capable of the indicated function)).
Regarding claim 30, modified Cho fails to explicitly disclose the limitations of the claim.
However, Cho does teach in an embodiment wherein at least some of the disposable patches are configured to detect different analytes (Cho (Par. 148, “As such, in the wearable electronic device 200, any one of the sensor units 205a, 205b, and 205c may be equipped to measure blood sugar and may be replaced with another of the sensor units 205a, 205b, and 205c to measure various biomarkers such as lactic acid or blood pressure.”)(Par. 12, “Accordingly, an aspect of the present disclosure is to provide a wearable electronic device having some replaceable parts, such as micro needles, and other parts that may be continuously used, such as a battery, detachably coupled with each other.”) (Par. 121, “As such, as the sensor unit 105 is received in the receiving unit and fastened by the cover unit 103 or is removed from the receiving unit as the cover unit 103 rotates, the sensor unit 105 may be replaced from the main body when necessary, while the circuit unit and battery in the main body may be continuously used along with the exchanged sensor unit 105.” (the sensor unit is capable of the indicated function)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Cho to include wherein at least some of the disposable patches are configured to detect different analytes through the combination of embodiments as it would have yielded the predictable result of monitoring differing biomarkers (Cho (Par. 148)).
Regarding claim 31, modified Cho fails to explicitly disclose the limitations of the claim.
However, Cho does teach in an embodiment wherein:
each patch is associated with a respective identifier (Cho (Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”)); and
when the pod is coupled to an individual patch, the instructions cause the processor to:
detect the respective identifier of the individual patch (Cho (Par. 107-108, “The sensor unit 105 contacts the body to detect a biomarker or to measure an electrical signal by the biomarker…” “…The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current.”); and
adjust a signal processing parameter based on the detected identifier (Cho (Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Cho to include wherein: each patch is associated with a respective identifier; and when the pod is coupled to an individual patch, the instructions cause the processor to: detect the respective identifier of the individual patch; and adjust a signal processing parameter based on the detected identifier through the combination of embodiments as it would have yielded the predictable result of monitoring differing biomarkers (Cho (Par. 148)).
Regarding claim 86, Cho discloses A device for monitoring a user (Par. 102, Fig. 1, wearable device 100), the device comprising:
a patch (Fig. 2, Pad – 104) (Par. 104, “The main body 101 includes a pad 104 on the rear surface of the main body 101 for placement on the user's body.”) configured to couple to the user's skin (Par. 105, “The pad 104 has an adhesive to allow the main body 101 to be worn on the user's body.”) (Examiner's Note: Interpreted under 112f as indicated above) and including means for accessing interstitial fluid in the user's skin (microneedles – 151 are observably carried by pad 104)) (Fig. 5, (microneedles 151 and sensor unit 105 on pad 104)) and generating a first electrical signal indicative of at least one analyte in the interstitial fluid (Par. 107, “…micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105.”) (Par. 108, “micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid. The conductive-polymer micro needles 151 receive an electric current to trigger a chemical action between the enzyme and the biomarker. The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current…” (electrical signal));
a pod configured to releasably couple to the patch (Par. 14, (sensor unit 105 is detachably coupled to the body unit)), the pod comprising:
processing means for (Par. 124, “The circuit unit 106 includes various electronic parts 161, such as a main chipset, communication module, power supplying unit, and storage unit, mounted thereon. The main chipset receives an electrical signal for a biomarker measured by the sensor unit 105.”) (Par. 110, “The circuit unit is electrically connected with the sensor unit 105 to receive a bio signal value measured by the sensor unit 105. The circuit unit includes a communication module to transmit the bio signal value to a separate electronic device 10. The communication module receives data from the separate electronic device 10, which stores the bio signal value received from the communication module or stores bio information analyzed via a separate algorithm or calculation using the bio signal value.”) (Par. 108, “According to an embodiment of the present disclosure, the micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid....”):
processing the first electrical signal to generate a first health measurement for the user (Par. 107, “The sensor unit 105 contacts the body to detect a biomarker or to measure an electrical signal by the biomarker. Hereinafter, the electrical signal is referred to as a bio signal...”) (Par. 110, “The circuit unit is electrically connected with the sensor unit 105 to receive a bio signal value measured by the sensor unit 105...”) (Par. 108, “the micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid. The conductive-polymer micro needles 151 receive an electric current to trigger a chemical action between the enzyme and the biomarker. The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current.”), and
communication means for transmitting the first health measurement to a remote device (Par. 124, “The circuit unit 106 includes various electronic parts 161, such as a main chipset, communication module, power supplying unit, and storage unit, mounted thereon. The main chipset receives an electrical signal for a biomarker measured by the sensor unit 105. The sensor unit 105 controls various electronic parts including the communication module, power supplying unit, and storage unit. The communication module communicates bio signals by the biomarker or communicate values by the bio signals…”).
Cho fails to explicitly disclose means for generating a second electrical signal indicative of at least one physiological parameter of the user.
However, Cho does teach in an alternate embodiment a plurality of different sensors (Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”).
Newberry teaches means for generating a second electrical signal indicative of at least one physiological parameter of the user (Par. 62, “The needles 106 are configured to pierce at least the upper epidermis of skin of a patient (human or animal) to administer medication to the patient.”) (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho with that of Cho and Newberry to include means for generating a second electrical signal indicative of at least one physiological parameter of the user through the combination of references and addition of a sensor as the use of multiple sensors and detection of multiple analytes is known (Cho (Par. 152, 153, 146))), it would have yielded the predictable result of tracking additional biomarkers (Cho (Par. 153)), and as it would have yielded the predictable result of monitoring patient vitals over time and track medication in the bloodstream of a patient (Newberry (Par. 66)).
Modified Cho fails to explicitly disclose processing the second electrical signal to generate a second health measurement for the user; and
communication means for transmitting the first and second health measurements to a remote device.
Cho does disclose processing the second electrical signal to generate a second health measurement for the user (Par. 107, “The sensor unit 105 contacts the body to detect a biomarker or to measure an electrical signal by the biomarker. Hereinafter, the electrical signal is referred to as a bio signal...”) (Par. 110, “The circuit unit is electrically connected with the sensor unit 105 to receive a bio signal value measured by the sensor unit 105...”) (Par. 108, “the micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid. The conductive-polymer micro needles 151 receive an electric current to trigger a chemical action between the enzyme and the biomarker. The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current.”); and
communication means for transmitting the first health measurements to a remote device (Par. 124, “The circuit unit 106 includes various electronic parts 161, such as a main chipset, communication module, power supplying unit, and storage unit, mounted thereon. The main chipset receives an electrical signal for a biomarker measured by the sensor unit 105. The sensor unit 105 controls various electronic parts including the communication module, power supplying unit, and storage unit. The communication module communicates bio signals by the biomarker or communicate values by the bio signals…”) (Par. 239, “FIG. 76 illustrates a network environment where a wearable electronic device operates according to an embodiment of the present disclosure.”) (Par. 255, “The communication interface 911 establishes communication between the electronic device 901 and an external electronic device…”).
Cho does teach a plurality of measurements from sensors (Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”).
Newberry further teaches processing the second electrical signal to generate a second health measurement for the user (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”) and second health measurement (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Cho and Newberry to include processing the second electrical signal to generate a second health measurement for the user; and communication means for transmitting the first of Cho and second health measurements to a remote device of Cho through the combination of references and addition of a sensor as the use of multiple sensors and detection of multiple analytes is known (Cho (Par. 152, 153, 146))), it would have yielded the predictable result of tracking additional biomarkers (Cho (Par. 153)) and as it would have yielded the predictable result of monitoring patient vitals over time and track medication in the bloodstream of a patient (Newberry (Par. 65-66)).
Regarding claim 87, modified Cho further discloses wherein the means for accessing interstitial fluid in the user's skin (Cho (microneedles – 151 are observably carried by pad 104)) (Fig. 5, (microneedles 151 and sensor unit 105 on pad 104)) and generating the first electrical signal includes one or more microneedles (Cho (Par. 107, “…micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105.”) (Par. 108, “micro needles 151 are formed of conductive polymer and contain an enzyme that performs a chemical action with the body fluid. The conductive-polymer micro needles 151 receive an electric current to trigger a chemical action between the enzyme and the biomarker. The micro needles 151 measure the biomarker using an electrical signal generated by the chemical action, i.e., an electrical current…” (electrical signal))).
Regarding claim 88, modified Cho fails to explicitly disclose the limitations of the claim.
However, Cho teaches in an embodiment wherein the means for accessing interstitial fluid in the user's skin and generating the first electrical signal includes one or more arrays of microneedles configured to detect two or more different analytes in the interstitial fluid ((Cho (Par. 107, “the sensor unit 105 includes micro needles 151 that are inserted into the body skin to collect a body fluid. When the micro needles 151 are inserted into the skin, the body fluid is delivered through the inside of the micro needles 151 to the sensor unit 105. “)(Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”)(Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Cho to include wherein the means for accessing interstitial fluid in the user's skin and generating the first electrical signal includes one or more arrays of microneedles configured to detect two or more different analytes in the interstitial fluid for the reasoning as indicated in claim 4 above.
Regarding claim 89, modified Cho fails to explicitly disclose the limitations of the claim.
However, Newberry further teaches wherein the means for generating the second electrical signal includes at least one optical sensor (Newberry (Par. 65, “he PPG circuit 110 may be configured to detect SPO.sub.2 levels, heart rate, blood pressure and/or concentration of substances in arterial blood flow of the patient as described in more detail herein…”)(Par. 62, “The needles 106 are configured to pierce at least the upper epidermis of skin of a patient (human or animal) to administer medication to the patient.”) (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”)).
Cho does teach in an alternate embodiment a plurality of different sensors (Cho (Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Newberry to include wherein the means for generating the second electrical signal includes at least one optical sensor through the combination of references and addition of a sensor as the use of multiple sensors and detection of multiple analytes is known (Cho (Par. 152, 153, 146))), it would have yielded the predictable result of tracking additional biomarkers (Cho (Par. 153)), and as it would have yielded the predictable result of monitoring patient vitals over time and track medication in the bloodstream of a patient (Newberry (Par. 66)).
Regarding claim 90, modified Cho fails to explicitly disclose the limitations of the claim.
However, Newberry further teaches wherein the at least one optical sensor includes a photoplethysmography (PPG) sensor, and the physiological parameter includes one or more of an oxygen level and/or a heart rate of the user. (Newberry (Par. 65, “he PPG circuit 110 may be configured to detect SPO.sub.2 levels, heart rate, blood pressure and/or concentration of substances in arterial blood flow of the patient as described in more detail herein…”)(Par. 62, “The needles 106 are configured to pierce at least the upper epidermis of skin of a patient (human or animal) to administer medication to the patient.”) (Par. 66, “one or more optical fibers may be inserted within the needles 106 and optically coupled to the PPG circuit 110. The PPG circuit 110 transmits and detects light through the optical fibers to monitor absorption of the medication into the skin and surrounding tissue of the patient using Beer-Lambert principles described in more detail herein. For example, the PPG circuit 110 is configured to transmit light at one or more wavelengths through the optical fibers onto the skin of the patient and detect the reflected light spectrum at the one or more wavelengths…”) (Par. 79, “The needles 106 are positioned to extend from a surface 302 of the IDDB system 100 towards the skin of the patient…”)).
Cho does teach in an alternate embodiment a plurality of different sensors (Cho (Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Newberry to include wherein the at least one optical sensor includes a photoplethysmography (PPG) sensor, and the physiological parameter includes one or more of an oxygen level and/or a heart rate of the user for the reasoning as indicated in claim 89 above.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho in view of Newberry as applied to claim 1 above, and further in view of Oh (US Pub. No. 20160331290) hereinafter Oh.
Cho and Newberry teach the device of claim 1 above.
Regarding claim 16, modified Cho fails to explicitly disclose the limitations of the claim.
However, Cho does teach in an alternate embodiment a plurality of different sensors (Fig. 26, Par. 152, “The plurality of sensor units 105a, 105b, 105c, and 105d measure the same biomarker, such as blood sugar. The circuit unit compares electrical signal values by the biomarkers received from the plurality of sensor units 105a, 105b, 105c, and 105d, and when the respective measured biomarker values have a large deviation, more accurately measures biomarkers, such as by transferring signals for re-measurement.”) (Par. 146, “The sensor units include a first sensor unit 205a, a second sensor unit 205b, and a third sensor unit 205c. The first sensor unit 205a measures blood sugar in a similar manner to the above-described embodiments…” “…At least one of the sensor units may be an optic sensor for measuring the body temperature, and another one of the sensor units may be a heartbeat measuring sensor.”) (Par. 153, “The plurality of sensor units 105a, 105b, 105c, and 105d measure different biomarkers in a similar manner to those described above in connection with the above embodiments”).
Oh teaches wherein the array of microneedles is further configured to generate a third electrical signal indicative of bioimpedance of the user's skin, and wherein the instructions further cause the processor to receive and process the third electrical signal to determine penetration of the microneedles into the user's skin (Par. 156, “The controller 160 determines whether the first bioimpedance is less than a reference value at step S2040. The first bioimpedance when the needle electrode is exposed to air varies from the first bioimpedance when the needle electrode is inserted into the subject. For example, when the needle electrode is inserted through skin of the subject, the first bioimpedance considerably decreases. Therefore, the controller 160 determines whether the needle electrode is inserted into the subject by using a value of the first bioimpedance. For example, when the first bioimpedance is less than the reference value, the controller 160 determines that the needle electrode is inserted into the subject. In this case, the reference value is a general value when the needle electrode is inserted into the subject and may be previously defined by examination.”).
Cho, Newberry and Oh are considered to be analogous art to the claimed invention as they are involved with biological sensing devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Cho and Newberry with that of Cho and Oh to include wherein the array of microneedles is further configured to generate a third electrical signal indicative of bioimpedance of the user's skin, and wherein the instructions further cause the processor to receive and process the third electrical signal to determine penetration of the microneedles into the user's skin through the combination of references and addition of a sensor as the use of multiple sensors is known (Cho (Par. 152, 153, 146))), and it would have yielded the predictable result of verifying insertion of the electrode (Oh (Par. 156)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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