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 .
Response to Arguments
Applicant’s arguments, see page 13, filed 02/12/2026, with respect to the objection to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant’s arguments, see page 13, filed 02/12/2026, with respect to the interpretation of the term “analyzing unit” under 35 U.S.C. § 112(f) have been fully considered and are persuasive. The interpretation of the term “analyzing unit” under 35 U.S.C. § 112(f) has been withdrawn.
Applicant’s arguments, see page 13, filed 02/12/2026, with respect to the rejection of Claims 1-15 and 17-26 under 35 U.S.C. § 112(b) have been fully considered and are mostly persuasive. The rejection of Claims 1-15 and 17-24 and 26 under 35 U.S.C. § 112(b) has been withdrawn. However a rejection of Claim 25 remains.
Applicant's arguments filed 02/12/2026 with respect to the rejection of Claims 1-15 and 17-26 under 35 U.S.C. § 101 have been fully considered but they are not persuasive.
The applicant has argued that the combination of VIS/NIR radiation source and an IR sensing unit, which is not disclosed in the prior art, is “not a question of merely changing the settings of a known device but rather necessitates the development and provision of entirely new devices as described in the present application.” (page 14). However, rather than an entirely new device, the claimed invention is a novel combination of known devices. A specific, non-conventional data gathering function performed by conventional data gathering structure(s) generally known in the non-invasive physiological parameter sensing arts does not make the structure itself non-conventional. Both the radiation source and the sensing unit are taught to be conventional structures by the applicant’s specification (page 10, lines 23-25; page 12, line 30), and nonconventional functions of a 400-1500 nm radiation wavelength and a 5-12 μm sensing wavelength to not make them amount to significantly more than the abstract idea.
Regarding Step 2A, Prong One, the applicant has argued “regarding claims 17 and 26, the steps recited herein require use of nonconventional physical devices (i.e., the configuration of the VIS/NIR radiation source and IR sensing unit) to yield a high-quality measurement of the present state of the physiological parameter for this subject. This method, therefore, cannot be completed only in the mind”. However, rather than asserting these steps could be done in the mind, the examiner is considering these structures as insignificant extra-solution activity, e.g. mere data gathering devices under Step 2A, Prong One and Step 2B.
Regarding Step 2A, Prong Two and Step 2B, the applicant has argued “Applicant has amended claims to specify the manner in which the analyzing unit makes the qualitative and/or quantitative determination of the physical psychological parameter, as discussed during the Examiner Interview. Applicant submits that, in view of the claim amendment submitted herewith, Applicant's claims more precisely define the analysis in such a way that the subject matter of Applicant's claims is patentable”. Applicant’s amendments to independent Claims 1, 17, and 25-26 recite “wherein the qualitative and/or quantitative determination of the physiological parameter is based on an intensity and/or decay time of the IR radiation detected in the at least one sensor (b)”. This amendment further limits the claimed abstract idea but still fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
Claim Objections
Claims 1, 17, and 25-26 are objected to because of the following informalities:
In Claims 1, 17, and 25-26, “wherein the analyzing unit comprises a A/D converter and a microcontroller” should read “wherein the analyzing unit comprises [[a]] an A/D converter and a microcontroller”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in Claim 25 is a relative term which renders the claim indefinite. The term “about” 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. For the purposes of substantive examination, the term “about” will not be construed as ± 25% of the claimed range.
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: “radiation source” in Claims 1 and 25.
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 1 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “radiation source” for the apparatus performing the specified function
“radiation source” is linked with the transitional phrase “adapted for” and modified by the functional language “emitting visual (VIS)/near-infrared (NIR) radiation in the range of 400 nm to 1500 nm or 500 nm to 1500 nm into a body part of said subject”
“radiation source” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on page 10, lines 25-27 as an LED, a laser diode, a VCSEL (vertical-cavity surface-emitting laser) or a laser, and equivalents thereof.
Claim 25 is being interpreted under 35 U.S.C. § 112(f) for substantially similar reasons as Claim 1, as it recites the same nonce terms modified by the same functional 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 and 17-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding Claim 1, the claim recites a non-invasive system for determining a physiological parameter in a bodily fluid of a subject. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
the qualitative and/or quantitative determination of the physiological parameter based on the IR radiation detected in the sensing unit (b)
wherein the qualitative and/or quantitative determination of the physiological parameter is based on an intensity and/or decay time of the IR radiation detected in the at least one sensor (b)
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
The qualitative and/or quantitative determination of the physiological parameter based on the IR radiation detected in the sensing unit (b) is a mental process that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
The qualitative and/or quantitative determination of the physiological parameter is based on an intensity and/or decay time of the IR radiation detected in the at least one sensor (b) is a mental process that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
(a) a radiation source adapted for emitting visual (VIS)/near-infrared (NIR) radiation in the range of 400 nm to 1500 nm into a body part of said subject, wherein the irradiated body part absorbs electromagnetic energy resulting in a local increase of tissue temperature and in an increased emission of IR radiation in the wavelength range of 5 µm to 12 µm
(b) at least one sensor for detecting emitted IR radiation from the previously irradiated body part of said subject in the range of 5 µm to 12 µm, wherein the previously irradiated body part exhibits a local increase of tissue temperature and an increased emission of IR radiation in the wavelength of 5 µm to 12 µm
wherein said at least one sensor is adapted for (i) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is dependent from the concentration of the physiological parameter in the bodily fluid of said subject, and for (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is independent from the concentration of the physiological parameter in the bodily fluid of said subject
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
an analyzing unit for...
wherein the analyzing unit comprises a A/D converter and a microcontroller
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
(a) a radiation source adapted for emitting visual (VIS)/near-infrared (NIR) radiation in the range of 400 nm to 1500 nm into a body part of said subject, wherein the irradiated body part absorbs electromagnetic energy resulting in a local increase of tissue temperature and in an increased emission of IR radiation in the wavelength range of 5 µm to 12 µm
(b) at least one sensor for detecting emitted IR radiation from the previously irradiated body part of said subject in the range of 5 µm to 12 µm, wherein the previously irradiated body part exhibits a local increase of tissue temperature and an increased emission of IR radiation in the wavelength of 5 µm to 12 µm
wherein said at least one sensor is adapted for (i) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is dependent from the concentration of the physiological parameter in the bodily fluid of said subject, and for (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is independent from the concentration of the physiological parameter in the bodily fluid of said subject
an analyzing unit for...
wherein the analyzing unit comprises a A/D converter and a microcontroller
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The radiation source is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 02/15/2022 (“The VIS/NIR radiation source (9, 9a, 9b) may be adapted for emitting collimated radiation, e.g. a laser-based light source, and/or adapted for emitting non-collimated radiation, e.g. an LED-based light source”, page 10, lines 23-25; LED and laser light sources, under broadest reasonable interpretation, are commercially available products in the optical signal processing arts).
The sensor is considered to be well-understood, routine, and conventional, under broadest reasonable interpretation, based on a statement from the applicant's specification filed 02/15/2022 (“In certain embodiments, sensor (4a) is an optical sensor, e.g. a photodiode”, page 12, line 30; photodiodes, under broadest reasonable interpretation, are commercially available products in the optical signal processing arts).
The analyzing unit is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 02/15/2022 (“The analyzing unit may comprise, for example, an A/D converter and a microcontroller.”, page 18, lines 26-28; microcontrollers, under broadest reasonable interpretation, are commercially available products in the signal processing arts).
Independent Claim 17 is also not patent eligible for substantially similar reasons as it recites the same abstract idea(s) and additional element(s) as Claim 1 but as a process-type claim..
Dependent Claims 3, 9, and 19-20 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea.
Dependent Claims 2, 4-15, 18, 21-24, and 27-34 also fail to add subject qualifying as significantly more to the abstract independent claims as they recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claims 2, 4-15, 18, 21-24, and 27-34 also fail to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claims as they do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Regarding Claim 25, the claim recites a non-invasive system for determining glucose in a bodily fluid of a subject. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
the qualitative and/or quantitative determination of the physiological parameter based on the IR radiation detected in the sensing unit (b)
wherein the qualitative and/or quantitative determination of the physiological parameter is based on an intensity and/or decay time of the IR radiation detected in the sensing unit (b)
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
the qualitative and/or quantitative determination of the physiological parameter based on the IR radiation detected in a sensing unit is a mental process and/or mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
the qualitative and/or quantitative determination of the physiological parameter based on an intensity and/or decay time of the IR radiation detected in the sensing unit (b) is a mental process and/or mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
(a) a radiation source adapted for emitting visual (VIS)/near-infrared (NIR) radiation in the range of 400 nm to 1500 nm into a body part of said subject, wherein the irradiated body part absorbs electromagnetic energy resulting in a local increase of tissue temperature and in an increased emission of IR radiation in the wavelength range of 5 µm to 12 µm
(b) at least one sensor for detecting emitted IR radiation from the previously irradiated body part of said subject in the range of 5 µm to 12 µm, wherein the previously irradiated body part exhibits a local increase of tissue temperature and an increased emission of IR radiation in the wavelength of 5 µm to 12 µm, wherein said at least one sensor is adapted for (i) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is dependent from the concentration of glucose in the bodily fluid of said subject, and for (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is independent from the concentration of glucose in the bodily fluid of said subject
wherein the at least one sensor (b) comprises at least two first sensors, wherein each of the at least two sensors is adapted to detect IR radiation having at least one first wavelength or first wavelength range where the intensity of the detected IR radiation is dependent from the concentration of glucose in the bodily fluid of said subject, wherein at least one first sensor is adapted to detect IR radiation having a wavelength of about 9.2 µm and at least one other first sensor is adapted to detect IR radiation having a wavelength range between 9.2 µm and 9.6 µm which comprises the first wavelength of 9.2 µm and further comprises a wavelength of 9.4 µm and 9.6 µm, wherein the at least one sensor comprises at least one second sensor, which is adapted to detect IR radiation having at least one second wavelength or second wavelength range where the intensity of the detected IR radiation is independent from the concentration of glucose in the bodily fluid of said subject
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
an analyzing unit for...
wherein the analyzing unit comprises a A/D converter and a microcontroller
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
(a) a radiation source adapted for emitting visual (VIS)/near-infrared (NIR) radiation in the range of 400 nm to 1500 nm into a body part of said subject, wherein the irradiated body part absorbs electromagnetic energy resulting in a local increase of tissue temperature and in an increased emission of IR radiation in the wavelength range of 5 µm to 12 µm
(b) at least one sensor for detecting emitted IR radiation from the previously irradiated body part of said subject in the range of 5 µm to 12 µm, wherein the previously irradiated body part exhibits a local increase of tissue temperature and an increased emission of IR radiation in the wavelength of 5 µm to 12 µm, wherein said at least one sensor is adapted for (i) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is dependent from the concentration of glucose in the bodily fluid of said subject, and for (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is independent from the concentration of glucose in the bodily fluid of said subject
wherein the at least one sensor (b) comprises at least two first sensors, wherein each of the at least two sensors is adapted to detect IR radiation having at least one first wavelength or first wavelength range where the intensity of the detected IR radiation is dependent from the concentration of glucose in the bodily fluid of said subject, wherein at least one first sensor is adapted to detect IR radiation having a wavelength of about 9.2 µm and at least one other first sensor is adapted to detect IR radiation having a wavelength range between 9.2 µm and 9.6 µm which comprises the first wavelength of 9.2 µm and further comprises a wavelength of 9.4 µm and 9.6 µm, wherein the at least one sensor comprises at least one second sensor, which is adapted to detect IR radiation having at least one second wavelength or second wavelength range where the intensity of the detected IR radiation is independent from the concentration of glucose in the bodily fluid of said subject
an analyzing unit for...
wherein the analyzing unit comprises a A/D converter and a microcontroller
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The radiation source is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 02/15/2022 (“The VIS/NIR radiation source (9, 9a, 9b) may be adapted for emitting collimated radiation, e.g. a laser-based light source, and/or adapted for emitting non-collimated radiation, e.g. an LED-based light source”, page 10, lines 23-25; LED and laser light sources, under broadest reasonable interpretation, are commercially available products in the optical signal processing arts).
The sensor is considered to be well-understood, routine, and conventional, under broadest reasonable interpretation, based on a statement from the applicant's specification filed 02/15/2022 (“In certain embodiments, sensor (4a) is an optical sensor, e.g. a photodiode”, page 12, line 30; photodiodes, under broadest reasonable interpretation, are commercially available products in the optical signal processing arts).
The analyzing unit is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 02/15/2022 (“The analyzing unit may comprise, for example, an A/D converter and a microcontroller.”, page 18, lines 26-28; microcontrollers, under broadest reasonable interpretation, are commercially available products in the signal processing arts).
Regarding Claim 26, the claim recites a method for non-invasively determining a physiological parameter in a bodily fluid of a subject. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
(c) analyzing the detected IR radiation for the qualitative and/or quantitative determination of the physiological parameter...
wherein the qualitative and/or quantitative determination of the physiological parameter is based on an intensity and/or decay time of the IR radiation detected in the sensing unit (b)
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally analyzing the detected IR radiation for the qualitative and/or quantitative determination of the physiological parameter with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
the qualitative and/or quantitative determination of the physiological parameter based on an intensity and/or decay time of the IR radiation detected in the sensing unit (b) is a mental process and/or mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
(a) irradiating a body part of said subject with visual (VIS)/near-infrared (NIR) radiation in the wavelength range of 400 nm to 1500 nm, wherein the irradiated body part absorbs electromagnetic energy resulting in a local increase of tissue temperature and in an increased emission of IR radiation in the wavelength range of 5 µm to 12 µm
(b) detecting emitted IR radiation from the previously irradiated body part of said subject in the wavelength range of 5 µm to 12 µm, wherein the previously irradiated body part exhibits a local increase of tissue temperature and an increased emission of IR radiation in the wavelength of 5 µm to 12 µm, comprising separately (i) detecting IR radiation having at least two wavelengths or wavelength ranges where the intensity of the detected IR radiation is dependent from the concentration of glucose in the bodily fluid of said subject, comprising detecting IR radiation having a wavelength of 9.2 µm and detecting IR radiation having a wavelength range between 9.2 µm and 9.6 µm which comprises the wavelength of 9.2 µm and further comprises a wavelength of about 9.4 µm and about 9.6 µm, (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is independent from the concentration of the physiological parameter in the bodily fluid of said subject
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
...by an analyzing unit
wherein the analyzing unit comprises an A/D converter and a microcontroller
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
(a) irradiating a body part of said subject with visual (VIS)/near-infrared (NIR) radiation in the wavelength range of 400 nm to 1500 nm, wherein the irradiated body part absorbs electromagnetic energy resulting in a local increase of tissue temperature and in an increased emission of IR radiation in the wavelength range of 5 µm to 12 µm
(b) detecting emitted IR radiation from the previously irradiated body part of said subject in the wavelength range of 5 µm to 12 µm, wherein the previously irradiated body part exhibits a local increase of tissue temperature and an increased emission of IR radiation in the wavelength of 5 µm to 12 µm, comprising separately (i) detecting IR radiation having at least two wavelengths or wavelength ranges where the intensity of the detected IR radiation is dependent from the concentration of glucose in the bodily fluid of said subject, comprising detecting IR radiation having a wavelength of 9.2 µm and detecting IR radiation having a wavelength range between 9.2 µm and 9.6 µm which comprises the wavelength of 9.2 µm and further comprises a wavelength of about 9.4 µm and about 9.6 µm, (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is independent from the concentration of the physiological parameter in the bodily fluid of said subject
...by an analyzing unit
wherein the analyzing unit comprises an) A/D converter and a microcontroller
Therefore, Claims 1-15 and 17-34 are not patent eligible under 35 U.S.C. § 101.
Examiner’s Note
The Examiner notes Claims 1-15 and 17-34 are not currently rejected under prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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