DETAILED ACTION
This office action is in response to the communication received on 01/15/2025 concerning application no. 18/580,827 filed on 01/15/2025.
Claims 1-15 are pending.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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:
“an implant device configured to insert…” in claims 1-3, 11, and 13-14: Paragraph 0091 teaches “An additional sensor may be configured for precise measurement of the analyte concentration in the body, but a size of the implant device 20 may be limited in that the implant device 20 is a sensor configured to insert into the body.”
“at least one external device configured to supply…” in claims 1, 3-4, 11, and 13-15: Paragraph 0034 teaches “The external device 30 refers to a sensor attached or worn outside the body of the subject to be analyzed and may be fastened to the outside of the body of the subject to be analyzed using various methods, such as a banding method and an adhesive method. The external device 30 may include a communication unit 31, and may provide biometric information to a paired or preset terminal 100 through the communication unit 31.”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-5, 7, 9, 12-13, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 is indefinite for the following reasons:
Recites “an analyte”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “analyte” is the same as the “surrounding analyte” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the blood vessel”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the interstitial fluid”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the tissue”. There is insufficient antecedent basis for this limitation in the claim.
Recites “perform measurement on an analyte that diffused from the blood vessel of the subject to be analyzed to the interstitial fluid within the tissue”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the scope of the claim is as the element is grammatical incorrect. It would be unclear what the “analyzed to the interstitial fluid” is establishing as the claim is establishing the measurement of analyte diffusing from the blood vessel. It is unclear if the claim is establishing that the analyte is diffusing from the blood vessel to the to the interstitial fluid within the tissue. However, that is further unclear as interstitial fluid is present throughout the tissue and is present within the vasculature itself.
Applicant is encouraged to provide consistent and clear language.
Claim 3 is indefinite for the following reasons:
Recites “a predetermined interval”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what interval is considered to be with respect to. It is unclear if it is establishing a temporal interval of operation of a spatial positioning.
Applicant is encouraged to provide consistent and clear language.
Recites “an electromagnetic wave”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “electromagnetic wave” is the same as the “electromagnetic wave” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “an analyte”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “analyte” is the same as the “surrounding analyte” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the interstitial fluid”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the outer skin”. There is insufficient antecedent basis for this limitation in the claim.
Recites “correction is performed on a measurement value of analyte concentration using measurement data”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the measurement is of the measure of the signal or another value associated to another collection. If it is the former, it is further unclear how the measurement value is correcting itself. If it is the later, it is unclear what reception or acquisition is of the measurement value such that it can be corrected.
Applicant is encouraged to provide consistent and clear language.
Recites “the electromagnetic wave measured by the first external device and the second external device”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what is measuring the EM wave as the claim 1 establishes that the implant device is emitting the wave and measuring the signal reflection.
Applicant is encouraged to provide consistent and clear language.
Claim 4 is indefinite for the following reasons:
Recites “the analyte”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the analyte”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “analyte” is the same as the “surrounding analyte” established claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “an electromagnetic wave”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “electromagnetic wave” is the same as the “electromagnetic wave” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the blood vessel”. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 is indefinite for the following reasons:
Recites “a conductive”. This claim element is indefinite. The claim is missing a noun. It is unclear what conductive object is being claimed. It would be unclear to one with ordinary skill in the art to assess the metes and bounds of the claim element as it is only an adjective.
Applicant is encouraged to provide consistent and clear language.
Recites “conducting wire configured to connect the via and the pad”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the claim is establishing the connection between and via what element. Furthermore, it is unclear how the pad relates to the claim element and the missing structures.
Applicant is encouraged to provide consistent and clear language.
Claim 7 is indefinite for the following reasons:
Recites “Rx”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the shortform stands for.
Applicant is encouraged to provide consistent and clear language.
Claim 9 is indefinite for the following reasons:
The term “substance selected for biosafety” is a relative term which renders the claim indefinite. The term “substance selected for biosafety” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Substances assessed for biosafety vary according to regulatory bodies and medical expertise. It would be unclear to one with ordinary skill in the art what is considered sufficiently biosafe for the claimed substance as it is a relative term of degree.
Claim 12 is indefinite for the following reasons:
Recites “the analyte”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the analyte”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “analyte” is the same as the “surrounding analyte” established in claim 11 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “an analyte”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “analyte” is the same as the “surrounding analyte” established in claim 11 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “an analyte”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “analyte” is the same as the “analyte” established in the preceding claim element or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the blood vessel”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the interstitial fluid”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the tissue”. There is insufficient antecedent basis for this limitation in the claim.
Recites “performing measurement on an analyte that diffused from the blood vessel of the subject to be analyzed to the interstitial fluid within the tissue”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the scope of the claim is as the element is grammatical incorrect. It would be unclear what the “analyzed to the interstitial fluid within the tissue” is establishing as the claim is establishing the measurement of analyte diffusing from the blood vessel. It is unclear if the claim is establishing that the analyte is diffusing from the blood vessel to the to the interstitial fluid within the tissue. However, that is further unclear as interstitial fluid is present throughout the tissue and is present within the vasculature itself.
Applicant is encouraged to provide consistent and clear language.
Claim 13 is indefinite for the following reasons:
Recites “a predetermined interval”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what interval is considered to be with respect to. It is unclear if it is establishing a temporal interval of operation of a spatial positioning.
Applicant is encouraged to provide consistent and clear language.
Recites “an electromagnetic wave”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “electromagnetic wave” is the same as the “electromagnetic wave” established in claim 11 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “an analyte”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “analyte” is the same as the “surrounding analyte” established in claim 11 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the interstitial fluid”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the outer skin”. There is insufficient antecedent basis for this limitation in the claim.
Recites “correction is performed on a measurement value of analyte concentration using measurement data”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the measurement is of the measure of the signal or another value associated to another collection. If it is the former, it is further unclear how the measurement value is correcting itself. If it is the later, it is unclear what reception or acquisition is of the measurement value such that it can be corrected.
Applicant is encouraged to provide consistent and clear language.
Recites “the electromagnetic wave measured by the first external device and the second external device”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what is measuring the EM wave as the claim 1 establishes that the implant device is emitting the wave and measuring the signal reflection.
Applicant is encouraged to provide consistent and clear language.
Claim 15 is indefinite for the following reasons:
Recites “a predetermined interval”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what interval is considered to be with respect to. It is unclear if it is establishing a temporal interval of operation of a spatial positioning.
Applicant is encouraged to provide consistent and clear language.
Recites “an electromagnetic wave”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “electromagnetic wave” is the same as the “electromagnetic wave” established in claim 14 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “an analyte”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “analyte” is the same as the “surrounding analyte” established in claim 14 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “the interstitial fluid”. There is insufficient antecedent basis for this limitation in the claim.
Recites “the outer skin”. There is insufficient antecedent basis for this limitation in the claim.
Recites “correction is performed on a measurement value of analyte concentration using measurement data”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the measurement is of the measure of the signal or another value associated to another collection. If it is the former, it is further unclear how the measurement value is correcting itself. If it is the later, it is unclear what reception or acquisition is of the measurement value such that it can be corrected.
Applicant is encouraged to provide consistent and clear language.
Recites “the electromagnetic wave measured by the first external device and the second external device”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what is measuring the EM wave as the claim 1 establishes that the implant device is emitting the wave and measuring the signal reflection.
Applicant is encouraged to provide consistent and clear language.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biometric information measurement device and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “to measure a signal reflected from a surrounding analyte”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the measure of a signal that is of an analyte. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “an implant device configured to insert into a body of a subject to be analyzed, to emit an electromagnetic wave of a specific frequency; and at least one external device configured to supply power to the implant device and to receive measurement data of the implant device”. The emission of an EM wave and the powering of the device for data reception is a data collection step which is a form of a pre-solution insignificant activity. The use of processors does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biometric information measurement device and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “perform measurement on an analyte that diffused from the blood vessel of the subject to be analyzed to the interstitial fluid within the tissue”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the measure of an analyte that is in a blood vessel of a subject. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the implant device is configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 2 is ineligible.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biometric information measurement device and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “measure an electromagnetic wave according to a change in concentration of an analyte in the interstitial fluid on the outer skin of the subject to be analyzed, and correction is performed on a measurement value of analyte concentration using measurement data measured by the implant device and the electromagnetic wave measured by the first external device and the second external device”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the measure of the concentration change of the analyte and the correction of measurement data based on measured concentration change. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the at least one external device includes a first external device and a second external device provided at a predetermined interval outside the body of the subject to be analyzed, the first external device and the second external device are coupled to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 3 is ineligible.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biometric information measurement device and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “perform measurement on the analyte by emitting an electromagnetic wave that reaches a depth of the blood vessel of the subject to be analyzed and by measuring the signal that reaches the blood vessel of the subject to be analyzed and is reflected from the analyte”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to measure of an analyte and the signal based on the blood vessel. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the at least one external device is configured to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 4 is ineligible.
Claim 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 5 recites the following elements: “a package; a conductive via formed in at least a portion of the package to connect inside and outside of the package; a measurement antenna connected to the conductive via on the outside of the package; a pad formed in the package and in which a system on chip (SOC) is formed; and a conducting wire configured to connect the via and the pad”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. The use of processing unit does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 5 is ineligible.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 6 recites the following elements: “a measurement antenna conducting wire provided along an outermost area of a package of the implant device; and a power receiving (Rx) coil provided in a center area of the package, spaced apart from the measurement antenna conducting wire”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 6 is ineligible.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 7 recites the following elements: “a power Rx coil provided along an outermost area of a package of the implant device; and a measurement antenna conducting wire provided in a center area of the package, spaced apart from the power Rx coil”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 7 is ineligible.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 8 recites the following elements: “wherein the implant device includes a coil having a sensing function and a power receiving function, and configured to switch between the sensing function and the power receiving function and to switch power reception from the at least one external device and the sensing function according to measurement of the reflected signal with emission of the electromagnetic wave”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 8 is ineligible.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 9 recites the following elements: “wherein outside of the implant device is coated with a substance selected for biosafety”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 9 is ineligible.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 10 recites the following elements: “wherein an external case of the implant device is applied or coated with an anti-inflammatory substance”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 10 is ineligible.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biometric information measurement method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “measuring, by the implant device, a signal reflected from a surrounding analyte by the emitted electromagnetic wave”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the measure of a signal that is of an analyte. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “receiving, by an implant device inserted into a body of a subject to be analyzed, supply of power from at least one external device located outside the body of the subject to be analyzed; emitting, by the implant device, an electromagnetic wave of a specific frequency using the supplied power; and transmitting, by the implant device, measurement data according to the measured signal to the at least one external device using the received power”. The emission of an EM wave and the powering of the device for data reception is a data collection step which is a form of a pre-solution insignificant activity. The use of processors does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 11 is ineligible.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biometric information measurement method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the measuring of the signal reflected from the analyte comprises: performing measurement on an analyte that diffused from the blood vessel of the subject to be analyzed to the interstitial fluid within the tissue”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the measure of an analyte that is in a blood vessel of a subject. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 12 is ineligible.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biometric information measurement method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “measure an electromagnetic wave according to a change in concentration of an analyte in the interstitial fluid on the outer skin of the subject to be analyzed, and correction is performed on a measurement value of analyte concentration using measurement data measured by the implant device and the electromagnetic wave measured by the first external device and the second external device”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the measure of the concentration change of the analyte and the correction of measurement data based on measured concentration change. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the at least one external device includes a first external device and a second external device provided at a predetermined interval outside the body of the subject to be analyzed, the first external device and the second external device are coupled to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 13 is ineligible.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biometric information measurement method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “measurement data that is measured by the implant device…calculating analyte concentration based on the received measurement data”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the calculation of analyte concentration based on measurement data and the measuring of data. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “supplying, by an external device located outside a body of a subject to be analyzed, power to an implant device inserted into the body of the subject to be analyzed; receiving, by the external device,…using the supplied power from the implant device”. The emission of an EM wave and the powering of the device for data reception is a data collection step which is a form of a pre-solution insignificant activity. The use of processors does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 14 is ineligible.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biometric information measurement method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “to measure an electromagnetic wave according to a change in concentration of an analyte in the interstitial fluid on the outer skin of the subject to be analyzed, and correction is performed on a measurement value of analyte concentration using measurement data measured by the implant device and the measured electromagnetic wave”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the measure of the concentration change of the analyte and the correction of measurement data based on measured concentration change. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the external device is coupled to another external device provided at a predetermined interval outside the body of the subject to be analyzed”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 15 is ineligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6-7, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bien (PGPUB No. US 2021/0186386).
Regarding claim 1, Bien teaches a biometric information measurement device comprising:
an implant device configured to insert into a body of a subject to be analyzed, to emit an electromagnetic wave of a specific frequency, and to measure a signal reflected from a surrounding analyte (Abstract teaches a glucose measurement device which is arranged and operates under the skin of a subject. Paragraph 0030 teaches that the measurement unit operates according to a resonant frequency that assess the change in permittivity. A resonant frequency by the specific pattern and the power feeder may change in response to a change in the permittivity around the measurement unit. A biometric-related parameter may be a parameter related to the resonant frequency of the measurement unit. The biometric-related parameter may include a scattering parameter of the measurement unit. Biometric information related to glucose may be indicated as glucose information.); and
at least one external device configured to supply power to the implant device and to receive measurement data of the implant device (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data).
Regarding claim 6, Bien teaches the biometric information measurement device in claim 1, as discussed above.
Bien further teaches a biometric information measurement device, wherein the implant device includes:
a measurement antenna conducting wire provided along an outermost area of a package of the implant device (Paragraph 0042 teaches that the resonance element is antenna based. See Fig. 5); and
a power receiving (Rx) coil provided in a center area of the package, spaced apart from the measurement antenna conducting wire (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data. Paragraph 0059 teaches that the coil can be cylindrical).
Regarding claim 7, Bien teaches the biometric information measurement device in claim 1, as discussed above.
Bien further teaches a biometric information measurement device, wherein the implant device includes:
a power Rx coil provided along an outermost area of a package of the implant device (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data. Paragraph 0059 teaches that the coil can be cylindrical); and
a measurement antenna conducting wire provided in a center area of the package, spaced apart from the power Rx coil (Paragraph 0042 teaches that the resonance element is antenna based. See Fig. 5).
Regarding claim 11, Bien teaches a biometric information measurement method comprising:
receiving, by an implant device inserted into a body of a subject to be analyzed, supply of power from at least one external device located outside the body of the subject to be analyzed (Abstract teaches a glucose measurement device which is arranged and operates under the skin of a subject. Paragraph 0030 teaches that the measurement unit operates according to a resonant frequency that assess the change in permittivity. A resonant frequency by the specific pattern and the power feeder may change in response to a change in the permittivity around the measurement unit. A biometric-related parameter may be a parameter related to the resonant frequency of the measurement unit. The biometric-related parameter may include a scattering parameter of the measurement unit. Biometric information related to glucose may be indicated as glucose information);
emitting, by the implant device, an electromagnetic wave of a specific frequency using the supplied power (Abstract teaches a glucose measurement device which is arranged and operates under the skin of a subject. Paragraph 0030 teaches that the measurement unit operates according to a resonant frequency that assess the change in permittivity. A resonant frequency by the specific pattern and the power feeder may change in response to a change in the permittivity around the measurement unit. A biometric-related parameter may be a parameter related to the resonant frequency of the measurement unit. The biometric-related parameter may include a scattering parameter of the measurement unit. Biometric information related to glucose may be indicated as glucose information);
measuring, by the implant device, a signal reflected from a surrounding analyte by the emitted electromagnetic wave (Abstract teaches a glucose measurement device which is arranged and operates under the skin of a subject. Paragraph 0030 teaches that the measurement unit operates according to a resonant frequency that assess the change in permittivity. A resonant frequency by the specific pattern and the power feeder may change in response to a change in the permittivity around the measurement unit. A biometric-related parameter may be a parameter related to the resonant frequency of the measurement unit. The biometric-related parameter may include a scattering parameter of the measurement unit. Biometric information related to glucose may be indicated as glucose information); and
transmitting, by the implant device, measurement data according to the measured signal to the at least one external device using the received power (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data).
Regarding claim 14, Bien teaches a biometric information measurement method comprising:
supplying, by an external device located outside a body of a subject to be analyzed, power to an implant device inserted into the body of the subject to be analyzed (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data);
receiving, by the external device, measurement data that is measured by the implant device using the supplied power from the implant device (Abstract teaches a glucose measurement device which is arranged and operates under the skin of a subject. Paragraph 0030 teaches that the measurement unit operates according to a resonant frequency that assess the change in permittivity. A resonant frequency by the specific pattern and the power feeder may change in response to a change in the permittivity around the measurement unit. A biometric-related parameter may be a parameter related to the resonant frequency of the measurement unit. The biometric-related parameter may include a scattering parameter of the measurement unit. Biometric information related to glucose may be indicated as glucose information); and
calculating analyte concentration based on the received measurement data (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data. Paragraphs 0028-30 teaches the consideration of the area in the skin and can access the change in glucose and can observe the concentration in the change in biometric information).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 2-4, 12-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bien (PGPUB No. US 2021/0186386) in view of Steil et al. (PGPUB No. US 2003/0130616).
Regarding claim 2, Bien teaches the biometric information measurement device in claim 1, as discussed above.
However, Bien is silent regarding a biometric information measurement device, wherein the implant device is configured to perform measurement on an analyte that diffused from the blood vessel of the subject to be analyzed to the interstitial fluid within the tissue.
In an analogous imaging field of endeavor, regarding glucose monitoring, Steil teaches a biometric information measurement device, wherein the implant device is configured to perform measurement on an analyte that diffused from the blood vessel of the subject to be analyzed to the interstitial fluid within the tissue (Paragraph 0256 teaches that the diffusion of the glucose from the blood plasma to the ISF can be assessed and monitored and vice versa through the tissue. Paragraph 0129 teaches that the delivery can be assessed through the vasculature as well).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Steil’s teaching of diffusion of an analyte. This modified apparatus would allow the user to dramatically improve wound healing, reduce blood stream infections, renal failure, and polyneuropathy mortality, irrespective of whether subjects previously had diabetes (Paragraph 0098 of Steil). Furthermore, the modification allows for the consideration of the lag of the present glucose value (Paragraphs 0255-56 of Steil).
Regarding claim 3, Bien teaches the biometric information measurement device in claim 1, as discussed above.
Bien further teaches a biometric information measurement device, wherein the at least one external device includes a first external device and a second external device provided at a predetermined interval outside the body of the subject to be analyzed, the first external device and the second external device are coupled to measure an electromagnetic wave according to a change in concentration of an analyte in the interstitial fluid on the outer skin of the subject to be analyzed (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data. Paragraphs 0028-30 teaches the consideration of the area in the skin and can access the change in glucose and can observe the concentration in the change in biometric information).
However, Bien is silent regarding a biometric information measurement device, correction is performed on a measurement value of analyte concentration using measurement data measured by the implant device and the electromagnetic wave measured by the first external device and the second external device.
In an analogous imaging field of endeavor, regarding glucose monitoring, Steil teaches a biometric information measurement device, correction is performed on a measurement value of analyte concentration using measurement data measured by the implant device and the electromagnetic wave measured by the first external device and the second external device (Paragraph 0088 teaches the assessment in the change in glucose in the body. Paragraphs 0124-25 teaches the assessment of the ISF glucose and providing a correction to calculate the glucose level and restarting the loop. This allows for the accounting of the error).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Steil’s teaching of correcting the analyte concentration. This modified apparatus would allow the user to dramatically improve wound healing, reduce blood stream infections, renal failure, and polyneuropathy mortality, irrespective of whether subjects previously had diabetes (Paragraph 0098 of Steil). Furthermore, the modification allows for the consideration of the lag of the present glucose value (Paragraphs 0255-56 of Steil).
Regarding claim 4, Bien teaches the biometric information measurement device in claim 1, as discussed above.
However, Bien is silent regarding a biometric information measurement device, wherein the at least one external device is configured to perform measurement on the analyte by emitting an electromagnetic wave that reaches a depth of the blood vessel of the subject to be analyzed and by measuring the signal that reaches the blood vessel of the subject to be analyzed and is reflected from the analyte.
In an analogous imaging field of endeavor, regarding glucose monitoring, Steil teaches a biometric information measurement device, wherein the at least one external device is configured to perform measurement on the analyte by emitting an electromagnetic wave that reaches a depth of the blood vessel of the subject to be analyzed and by measuring the signal that reaches the blood vessel of the subject to be analyzed and is reflected from the analyte (Paragraph 0256 teaches that the diffusion of the glucose from the blood plasma to the ISF can be assessed and monitored and vice versa through the tissue. Paragraph 0129 teaches that the delivery can be assessed through the vasculature as well. Paragraph 0321 teaches the operation via an external glucose sensor to assess at the same time as an internal sensor).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Steil’s teaching of an external sensor. This simultaneous use of the external device can be via the sensor modality as taught by Bien. This modified apparatus would allow the user to dramatically improve wound healing, reduce blood stream infections, renal failure, and polyneuropathy mortality, irrespective of whether subjects previously had diabetes (Paragraph 0098 of Steil). Furthermore, the modification allows for the consideration of the lag of the present glucose value (Paragraphs 0255-56 of Steil).
Regarding claim 12, Bien teaches the biometric information measurement method in claim 11, as discussed above.
However, Bien is silent regarding a biometric information measurement method, wherein the measuring of the signal reflected from the analyte comprises:
performing measurement on an analyte that diffused from the blood vessel of the subject to be analyzed to the interstitial fluid within the tissue.
In an analogous imaging field of endeavor, regarding glucose monitoring, Steil teaches a biometric information measurement method, wherein the measuring of the signal reflected from the analyte comprises:
performing measurement on an analyte that diffused from the blood vessel of the subject to be analyzed to the interstitial fluid within the tissue (Paragraph 0256 teaches that the diffusion of the glucose from the blood plasma to the ISF can be assessed and monitored and vice versa through the tissue. Paragraph 0129 teaches that the delivery can be assessed through the vasculature as well).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Steil’s teaching of diffusion of an analyte. This modified method would allow the user to dramatically improve wound healing, reduce blood stream infections, renal failure, and polyneuropathy mortality, irrespective of whether subjects previously had diabetes (Paragraph 0098 of Steil). Furthermore, the modification allows for the consideration of the lag of the present glucose value (Paragraphs 0255-56 of Steil).
Regarding claim 13, Bien teaches the biometric information measurement method in claim 11, as discussed above.
Bien further teaches a biometric information measurement method, wherein the at least one external device includes a first external device and a second external device provided at a predetermined interval outside the body of the subject to be analyzed, the first external device and the second external device are coupled to measure an electromagnetic wave according to a change in concentration of an analyte in the interstitial fluid on the outer skin of the subject to be analyzed (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data. Paragraphs 0028-30 teaches the consideration of the area in the skin and can access the change in glucose and can observe the concentration in the change in biometric information).
However, Bien is silent regarding a biometric information measurement method, correction is performed on a measurement value of analyte concentration using measurement data measured by the implant device and the electromagnetic wave measured by the first external device and the second external device.
In an analogous imaging field of endeavor, regarding glucose monitoring, Steil teaches a biometric information measurement method, correction is performed on a measurement value of analyte concentration using measurement data measured by the implant device and the electromagnetic wave measured by the first external device and the second external device (Paragraph 0088 teaches the assessment in the change in glucose in the body. Paragraphs 0124-25 teaches the assessment of the ISF glucose and providing a correction to calculate the glucose level and restarting the loop. This allows for the accounting of the error).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Steil’s teaching of correcting the analyte concentration. This modified method would allow the user to dramatically improve wound healing, reduce blood stream infections, renal failure, and polyneuropathy mortality, irrespective of whether subjects previously had diabetes (Paragraph 0098 of Steil). Furthermore, the modification allows for the consideration of the lag of the present glucose value (Paragraphs 0255-56 of Steil).
Regarding claim 15, Bien teaches the biometric information measurement method in claim 14, as discussed above.
Bien further teaches a biometric information measurement method, wherein the external device is coupled to another external device provided at a predetermined interval outside the body of the subject to be analyzed to measure an electromagnetic wave according to a change in concentration of an analyte in the interstitial fluid on the outer skin of the subject to be analyzed (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data. Paragraphs 0028-30 teaches the consideration of the area in the skin and can access the change in glucose and can observe the concentration in the change in biometric information).
However, Bien is silent regarding a biometric information measurement method, correction is performed on a measurement value of analyte concentration using measurement data measured by the implant device and the measured electromagnetic wave.
In an analogous imaging field of endeavor, regarding glucose monitoring, Steil teaches a biometric information measurement method, correction is performed on a measurement value of analyte concentration using measurement data measured by the implant device and the measured electromagnetic wave (Paragraph 0088 teaches the assessment in the change in glucose in the body. Paragraphs 0124-25 teaches the assessment of the ISF glucose and providing a correction to calculate the glucose level and restarting the loop. This allows for the accounting of the error).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Steil’s teaching of correcting the analyte concentration. This modified method would allow the user to dramatically improve wound healing, reduce blood stream infections, renal failure, and polyneuropathy mortality, irrespective of whether subjects previously had diabetes (Paragraph 0098 of Steil). Furthermore, the modification allows for the consideration of the lag of the present glucose value (Paragraphs 0255-56 of Steil).
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bien (PGPUB No. US 2021/0186386) in view of Sparks et al. (PGPUB No. US 2008/0077016).
Regarding claim 5, Bien teaches the biometric information measurement device in claim 1, as discussed above.
Bien further teaches a biometric information measurement device, wherein the implant device includes:
a package (Paragraph 0054 teaches the overall structure of the device. See Fig. 5);
a conductive via formed in at least a portion of the package to connect inside and outside of the package (Paragraph 0055 teaches that the measurement unit is able to be spread and rolled in a desired form. See Fig. 5);
a measurement antenna connected to the conductive via on the outside of the package (Paragraph 0042 teaches that the resonance element is antenna based. See Fig. 5);
a conducting wire configured to connect the via and the pad (Paragraph 0057 teaches the use of a input port for the measurement unit. It is shown in Fig. 5).
However, Bien is silent regarding a biometric information measurement device, a pad formed in the package and in which a system on chip (SOC) is formed.
In an analogous imaging field of endeavor, regarding implantable sensor systems, Sparks teaches a biometric information measurement device, a pad formed in the package and in which a system on chip (SOC) is formed (Paragraph 0026 teaches that the implant uses an IC chip with circuitry. See Fig. 2).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Sparks’s teaching of an integrated ship for the implant. This modified apparatus would allow the user to improve the transmission range of the implant (Paragraph 0043 of Sparks). Furthermore, the modification will assist in obtaining an accurate reading and appropriate decision about the integrity of the implant (Paragraph 0045 of Sparks).
Regarding claim 8, Bien teaches the biometric information measurement device in claim 1, as discussed above.
Bien further teaches a biometric information measurement device, wherein the implant device includes a coil having a sensing function and a power receiving function (Paragraph 0043 teaches the communication unit may transmit, to the external device, data indicative of a measured scattering parameter. Furthermore, the communication unit may receive power for generating a signal supplied to the measurement unit using a wireless power transmission method. The communication unit may include a coil, and may wirelessly receive power or transmit data. Paragraph 0059 teaches that the coil can be cylindrical).
However, Bien is silent regarding a biometric information measurement device, configured to switch between the sensing function and the power receiving function and to switch power reception from the at least one external device and the sensing function according to measurement of the reflected signal with emission of the electromagnetic wave.
In an analogous imaging field of endeavor, regarding implantable sensor systems, Sparks teaches a biometric information measurement device, configured to switch between the sensing function and the power receiving function and to switch power reception from the at least one external device and the sensing function according to measurement of the reflected signal with emission of the electromagnetic wave (Paragraph 0006 teaches that the coil allows for the alternation of the EM filed that is facilitating transmission and reception and can induce voltage in the implant. This can be used as a power supply for signal conversion and communication).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Sparks’s teaching of the sensing and power alteration for the implant. This modified apparatus would allow the user to improve the transmission range of the implant (Paragraph 0043 of Sparks). Furthermore, the modification will assist in obtaining an accurate reading and appropriate decision about the integrity of the implant (Paragraph 0045 of Sparks).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bien (PGPUB No. US 2021/0186386) in view of Najafi et al. (US Patent No. 9,498,130).
Regarding claim 9, Bien teaches the biometric information measurement device in claim 1, as discussed above.
However, Bien is silent regarding a biometric information measurement device, wherein outside of the implant device is coated with a substance selected for biosafety.
In an analogous imaging field of endeavor, regarding implantable sensor systems, Najafi teaches a biometric information measurement device, wherein outside of the implant device is coated with a substance selected for biosafety (Claim 11 teaches that the implant coating can be of silicone).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Najafi’s teaching of silicone coating. This modified apparatus would allow the user to provide a non-thrombogenic exterior for the biologic environment (Col. 7, lines 1-5 of Najafi). Furthermore, the modification greatly improves its prospects for long-term implantation (Col. 1, lines 49-62 of Najafi).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bien (PGPUB No. US 2021/0186386) in view of Boock et al. (PGPUB No. US 2024/0000352).
Regarding claim 10, Bien teaches the biometric information measurement device in claim 1, as discussed above.
However, Bien is silent regarding a biometric information measurement device, wherein an external case of the implant device is applied or coated with an anti-inflammatory substance.
In an analogous imaging field of endeavor, regarding implantable sensor systems, Boock teaches a biometric information measurement device, wherein an external case of the implant device is applied or coated with an anti-inflammatory substance (Paragraph 0182 teaches the incorporation of anti-inflammatory agent into the analyte sensor system such as tranilast).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Bien with Book’s teaching of the use of tranilast. This modified apparatus would allow the user to reduce acute or chronic inflammation (Paragraph 0182 of Boock). Furthermore, the modification will reduce noise and improve sensor accuracy (Paragraph 0114 of Boock).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bien et al. (PGPUB No. US 2019/0254576): Teaches an implantable blood glucose measuring apparatus and method.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
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