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 filed 08/19/2025 have been fully considered but are moot in view of a new grounds of rejection.
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 1-18 and 20-31 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.
In re claim 20, the limitation, “wherein the method is carried out without excitation by an external source of IR radiation” is unclear, specifically regarding how excitation can occur without excitation by an external source of IR radiation, since there is usually an external source of IR radiation such as ambient light or sunlight. For examination purposes, the limitation, “wherein the method is carried out without excitation by an external source of IR radiation” is interpreted as not requiring an external source of IR radiation. In other words, the method may be carried out even when there is no excitation by an external source of IR radiation.
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.
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:
In re claim 1:
a unit for receiving a body region to be examined
a radiation source for generating terahertz radiation
a unit for acquiring radiation from the body region to be examined
a unit for acquiring reflected terahertz radiation from the body region to be examined
(i) a unit for acquiring reflected terahertz radiation from the body region to be examined
(ii ) an infrared radiation (IR) acquisition a unit for acquiring a body's own IR radiation from the body region to be examined
an evaluation unit which is designed for temperature-compensated evaluation of the terahertz signals originating from the body radiation acquisition unit (c)(i) and the body's own IR signals originating from IR acquisition unit (c)(ii)
In re claim 6:
the unit for acquiring reflected terahertz radiation from the body region to be examined is designed to acquire a broadband spectrum in the terahertz range
In re claim 7:
the unit for acquiring reflected terahertz radiation from the body region to be examined is designed to bring about single- step or multi-step amplification
In re claim 8:
the unit for acquiring reflected terahertz radiation from the body region to be examined is designed for combined acquisition of reflected terahertz radiation from the body region to be examined and terahertz radiation radiated into the body region to be examined
In re claim 10:
the unit for receiving the body region to be examined (a) comprises an element which is thermally insulating, at least in part, with respect to the body radiation acquisition unit for acquiring radiation from the body region to be examined
In re claim 11:
the unit for receiving the body region to be examined
In re claim 12:
the IR acquisition unit
In re claim 13:
The IR acquisition unit comprises two or more second sensors which are designed for acquiring IR radiation of different wavelengths or wavelength range
In re claim 14:
the body radiation acquisition unit is in contact with a thermally conductive carrier
In re claim 15:
body radiation acquisition unit for acquiring radiation from the body region to be examined
In re claim 17:
The evaluation unit is provided for temperature- compensated evaluation
In re claim 18:
the evaluation unit is provided for combined evaluation of the signals from the unit for acquiring reflected terahertz radiation from the body region to be examined and the IR acquisition unit for acquiring the body's own IR radiation from the body region to be examined
In re claim 20:
the temperature in a region of the unit for acquiring IR radiation being lower than the temperature of the body region to be examined
In re claim 24:
The IR acquisition unit
In re claim 25:
the unit for measuring temperature in the body region to be examined
In re claim 26:
the evaluation unit
In re claim 28:
the unit for acquiring reflected terahertz radiation from the body region to be examined
In re claim 29:
the unit for receiving the body region to be examined comprises sensors for acquiring and/or monitoring a contact pressure of the body region to be examined unit
In re claim 30:
the IR acquisition unit
In re claim 31:
the unit for acquiring reflected terahertz radiation from the body region to be examined
the IR acquisition unit for acquiring the body's own IR radiation from the body region to be examined
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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6, 8, 12-13, 15-18, 20, 22-25, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Gerlitz (US 2009/0259407) in view of Barnes et al. (US 2016/0080665) in view of Mandelis et al. (US 2007/0213607) in view of Mueller et al. (US 2007/0114418).
In re claim 20, Gerlitz discloses a method for non-invasive [0018] quantitative determination of glucose [0018] in blood of a test subject [0018], the method comprising:
(ii) separately acquiring from the test subject the body's own IR radiation ([0041]: temperature is used to stimulate absorption of body’s own IR radiation; fig. 4-5: no external source of radiation is provided)
of at least one first wavelength ([0027]: second wavelength band) or one first wavelength range in a wavelength region (optional), where an intensity of the body's own IR radiation is substantially independent of glucose concentration ([0027]: second wavelength has negligible FIR absorption i.e. independent of glucose concentration), and
of at least one second wavelength ([0027]: first wavelength band) or one second wavelength range in the wavelength region (optional), where an intensity of the body's own IR radiation changes in a manner dependent on glucose concentration ([0027]: first wavelength has significant FIR absorption i.e. dependent of on glucose concentration),
the temperature in a region of the unit for acquiring IR radiation being lower than the temperature of the body region to be examined (fig. 5: system 39, healing/cooling apparatus 44, Peltier element 82, and fan 84; [0041]: fan 84 and Peltier element 92 will control cooling provided to system 38 which will cause the temperature in the system to be lower than a temperature of a body surface since the body surface temperature will start at a higher temperature until it’s cooled; [0037]),
(iii) evaluating a combination of signals acquired according to (ii) ([0027-0028]: combination of first and second FIR measurements) taking account of temperature of the body region and temperature where the IR radiation is acquired ([0027-0028]), and
(iv) determining glucose concentration based on an evaluated combination of signals ([0027-0028]: combination of first and second FIR measurements allows for non-invasive determination of FIR absorption for a substance of interest such as glucose).
Gerlitz fails to disclose the method comprising:
irradiating a body region originating from the test subject with terahertz radiation in a wavelength region from approximately 0.1 mm to approximately 5 mm and acquiring reflected terahertz radiation from the irradiated body region in a wavelength range in which an intensity of the reflected terahertz radiation changes in a manner dependent on glucose concentration,
(ii) separately acquiring from the test subject the body's own IR radiation of at least one first wavelength or one first wavelength range in a wavelength region from approximately 8pm to approximately 12 pm, …and of at least one second wavelength or one second wavelength range in the wavelength region from approximately 8 pm to approximately 12 pm,
(iii) evaluating a combination of signals acquired according to (i) and (ii) taking account of temperature of the body region and temperature where the terahertz radiation and the IR radiation are acquired;
wherein the method is carried out without excitation by an external source of IR radiation ([0041]: temperature is used to stimulate absorption of body’s own IR radiation; fig. 5: no external source of radiation is provided).
Barnes teaches an analogous method for non-invasive quantitative determination of glucose in blood of a test subject [0009-0010, 0381], the method comprising:
(i) irradiating a body region originating from the test subject [0106-0107, 0136] with terahertz radiation in a wavelength region from approximately 0.1 mm to approximately 5 mm ([0088]: 100 µm to about 1 mm includes .1mm); and
acquiring reflected terahertz radiation from the irradiated body region [0106, 0136] in a wavelength range in which an intensity of the reflected terahertz radiation changes in a manner dependent on glucose concentration ([0135-0136]: THz sensor is capable of detecting variations in the density and composition of tissue; [0379, 0381]: capable of detecting glucose concentration; [0095]),
(ii) separately acquiring from the test subject the body's IR radiation ([0107]: additional sensors may also be used, such as a mid-wave infrared sensor and a long-wave infrared sensor; [0091-0094]: light is measured from regions 201’ of the subject which is interpreted as acquiring the body’s own IR radiation) of at least
one first wavelength ([0107]: a first sensor for instance a thermal imaging sensor will have a first wavelength range; [0044-0045, 0088]) or
one first wavelength range
where an intensity of the body's own IR radiation is substantially independent of glucose concentration ([0088, 0095]: one of the sensors can be used which doesn’t have a wavelength range where glucose concentration affects the intensity of the body’s own IR radiation; [0044-0045]: any combination of sensor can be used to diagnose a medical condition, for instance a sensor which has a wavelength range dependent on a chemical other than glucose [0381]), and of at least
one second wavelength ([0107]: different sensor for instance a long wave infrared sensor will have a second wavelength range; [0044-0045, 0088]) or
one second wavelength range,
where an intensity of the body's own IR radiation changes in a manner dependent on glucose concentration ([0088, 0095, 0381]: one of the sensors and wavelength range where glucose concentration does affect the intensity of the body’s own IR radiation can be selected),
(iii) evaluating signals acquired according to (i) or (ii) ([0094-0095]: system determines presence of chemical based on evaluated signals; [0106-0107]: THZ sensor from (i) and additional sensor from (ii) can be used; [0381]: example of chemicals that can be characterized includes glucose) taking account of
temperature of the body region ([0144]: contact probe can further characterize a subject; [0148]: contact probe can measure temperature associated with a suspect region) and
temperature where the terahertz radiation and the IR radiation are acquired ([0148]: temperature where the terahertz radiation and the IR radiation i.e. on the body region are acquired will have to be taken account of at some point during the process through contact probes which measure temperature associated with a suspect region; [0383]: suspect region can be chosen from plurality of regions of skin where a first indication is indicated (i.e. location where the terahertz radiation and the IR radiation are acquired; [0049]), and
(iv) determining glucose concentration based on evaluated signals ([0381]: determines levels of certain chemicals based on evaluated signals; [0095]).
Barnes further teaches that terahertz imaging is useful because terahertz radiation is not damaging to tissue and is capable of detecting variations in composition of tissue [0135], and that signals may be evaluated based on either terahertz radiation or IR radiation ([0094-0095]: system determines presence of chemical based on evaluated signals; [0106-0107]: THZ sensor from (i) and additional sensor from (ii) can be used; [0381]: example of chemicals that can be characterized includes glucose).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the non-invasive method taught by Gerlitz, to provide irradiating a body region originating from the test subject with terahertz radiation in a wavelength region from approximately 0.1 mm to approximately 5 mm and acquiring reflected terahertz radiation from the irradiated body region in a wavelength range in which an intensity of the reflected terahertz radiation changes in a manner dependent on glucose concentration, as taught by Barnes, because terahertz imaging is useful at not damaging tissue and being capable of detecting variations in composition of tissue [0135], and because signals may be evaluated based on either terahertz radiation or IR radiation.
Regarding the limitations,
“(ii) separately acquiring from the test subject the body's own IR radiation of at least
one first wavelength or
one first wavelength range
in a wavelength region from approximately 8 um to approximately 12 um…
where an intensity of the body's own IR radiation is substantially independent of glucose concentration, and
of at least
one second wavelength or
one second wavelength range
in the wavelength region from approximately 8 um to approximately 12 um,”
Mandelis teaches a non-invasive glucose monitoring apparatus [0004], and teaches
separately acquiring from a test subject a body's own IR radiation of at least
one first wavelength ([0026]: reference wavelength of 10.5 um) or
one first wavelength range
in a wavelength region from approximately 8 um to approximately 12 um [0026]
where an intensity of the body's own IR radiation is substantially independent of glucose concentration ([0026]: reference wavelength of 10.5 um is directed towards measuring contributions of water and other tissue substances and is therefore substantially independent of glucose), and of at least
one second wavelength ([0026]: peak of glucose absorption at 9.6 um wavelength) or
one second wavelength range
in the wavelength region from approximately 8 um to approximately 12 um [0026],
where an intensity of the body's own IR radiation changes in a manner dependent on glucose concentration ([0026]: intensity-modulated laser radiation is considered and is dependent on glucose concentration; [0023]).
Mandelis further teaches that being able to adjust the baseline in real-time allows for precise and universal calibration [0022], and allows for accurate absolute glucose concentration readings [0022].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the non-invasive method yielded by the proposed combination, to provide (ii) separately acquiring from the test subject the body's own IR radiation of at least one first wavelength or one first wavelength range in a wavelength region from approximately 8 um to approximately 12 um, where an intensity of the body's own IR radiation is substantially independent of glucose concentration, and of at least one second wavelength or one second wavelength range in the wavelength region from approximately 8 um to approximately 12 um, as taught by Mandelis, because being able to adjust the baseline in real-time allows for precise and universal calibration, and allows for accurate absolute glucose concentration readings
Regarding the limitations,
“(iii) evaluating a combination of signals acquired according to (i) and (ii)…., and
(iv) determining glucose concentration based on an evaluated combination of signals,”
Mueller teaches an apparatus for detecting a substance on a person [0007], and teaches
(iii) evaluating a combination of signals acquired according to a terahertz sensor ([0066]: THz trans-receiver) and an infrared sensor ([0066]: data from the THZ trans-receiver is combined with data from an IR camera), and
(iv) determining a substance presence based on an evaluated combination of signals ([0066]: evaluated combination of signals is used to confirm presence of a substance).
Mueller further teaches that using a combination of signals with different operating frequencies provides a contrast [0066], and can be used as a cue to use the THZ trans-receiver to confirm the presence of a substance [0066], especially when the IR camera did not offer sufficient resolution or positive identification [0066].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the non-invasive method yielded by the proposed combination, to provide (iii) evaluating a combination of signals acquired according to a terahertz sensor and an infrared sensor, and (iv) determining glucose concentration based on an evaluated combination of signals, as taught by the determination of the presence of a substance of Mueller, because the terahertz sensor can be used to confirm the presence of a substance, especially when the infrared sensor did not offer sufficient resolution or positive identification, and also because using two sensors with different operating frequencies provides a contrast.
Regarding the limitations,
“(iii) evaluating a combination of signals acquired according to (i) and (ii) taking account of temperature of the body region and temperature where the terahertz radiation and the IR radiation are acquired, and
(iv) determining glucose concentration based on an evaluated combination of signals,”
the proposed combination yielded above yields the above recited limitation. Specifically, Gerlitz teaches adjusting the temperature in the region of the unit for acquiring IR radiation, which allows for the temperature where the terahertz radiation and the IR radiation are acquired to be to be taken account of including the temperature of the body region (i.e. under broadest reasonable interpretation of “taking account”, the temperature has to be taken into consideration at one point during the process). Gerlitz also teaches separately acquiring from the test subject the body's own IR radiation and Barnes teaches separately evaluating signals acquired according to (i). Additionally, Mandelis teaches separately acquiring IR radiation of two different wavelengths within a wavelength region of 8 um to 12 um so that glucose can be separated from a baseline of water and other tissue substances, and then Mueller is used to teach detecting the presence of a substance using both IR radiation and a terahertz detector, which is useful for Barnes to be able to determine glucose concentration based on an evaluated combination of signals, so that increased resolution and a positive indication of glucose is provided.
In re claim 1, Gerlitz discloses a method [0018] which is performed using a device (fig. 5: 39), wherein the device comprises:
(a) a unit (fig. 5: combination of three IR detector 56) for receiving a body region to be examined [0036-0037, 0018-0019], originating from the test subject [0018-0019],
(c) a body radiation acquisition unit (fig. 5: one of the detectors 56) for acquiring radiation from the body region to be examined [0036-0038], comprising:
(ii) an infrared radiation (IR) acquisition unit (fig. 5: 56) for acquiring a body's own IR radiation from the body region to be examined [0041],
wherein said unit is designed for separate acquisition of IR radiation in at least
two different wavelengths (see in re claim 20 above) or
wavelength ranges…,
…at a first wavelength or a first wavelength range intensity of the body's own IR radiation being substantially independent of glucose concentration (see in re claim 20 above), and at a second wavelength or a second wavelength range intensity of the body's own IR radiation changing in a manner dependent on glucose concentration (see in re claim 20 above), and
(d) an element for measuring temperature in the body region to be examined ([0027-0028]: unit that measures temperature),
(e) (i) an element for measuring temperature in the body radiation acquisition unit (c) (see in re claim 20 above).
Gerlitz fails to disclose
(b) a radiation source for generating terahertz radiation in a wavelength region from approximately 0.1 mm to approximately 5 mm for irradiating a body region to be examined,
(c) a body radiation acquisition unit for acquiring radiation from the body region to be examined, comprising: (i) a unit for acquiring reflected terahertz radiation from the body region to be examined, wherein said unit is designed for acquiring terahertz radiation in a wavelength range in which intensity of the reflected terahertz radiation changes in a manner dependent on glucose concentration.
Barnes teaches
(a) a unit for receiving a body region to be examined ([0081]: system 200 can be handheld and include fiber optics that are moved to obtain reflected light from different parts of a subject), originating from the test subject [0081],
(b) a radiation source for generating terahertz radiation [0106-0107, 0136] in a wavelength region from approximately 0.1 mm to approximately 5 mm for irradiating a body region to be examined (see in re claim 20 above),
(c) a body radiation acquisition unit for acquiring radiation from the body region to be examined (Fig. 2A: Sensor subsystem 230: [0083-0084]), comprising:
(i) a unit (290) for acquiring reflected terahertz radiation from the body region to be examined [0106, 0136], wherein said unit is designed for acquiring terahertz radiation in a wavelength range in which intensity of the reflected terahertz radiation changes in a manner dependent on glucose concentration ([0135-0136]: THz sensor is capable of detecting variations in the density and composition of tissue; [0379, 0381]: capable of detecting glucose concentration; [0095]),
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the non-invasive method taught by Gerlitz, to provide (iii(b) a radiation source for generating terahertz radiation in a wavelength region from approximately 0.1 mm to approximately 5 mm for irradiating a body region to be examined, (c) a body radiation acquisition unit for acquiring radiation from the body region to be examined, comprising: (i) a unit for acquiring reflected terahertz radiation from the body region to be examined, wherein said unit is designed for acquiring terahertz radiation in a wavelength range in which intensity of the reflected terahertz radiation changes in a manner dependent on glucose concentration, as taught by Barnes, for substantially the same reasons as discussed in re claim 20 above.
Regarding the limitations,
“wherein said unit is designed for separate acquisition of IR radiation in… a wavelength region from approximately 8 um to approximately 12 m,
(e)
(ii) an element for adjusting temperature in the body radiation acquisition unit (c),
it being provided for the temperature in the body radiation acquisition unit (c) to be lower than in the body region to be examined, and
(f) an evaluation unit which is designed for temperature-compensated evaluation of terahertz signals originating from the body radiation acquisition unit (c)(i) and the body's own IR signals originating from IR acquisition unit (c)(ii), and
for determining glucose concentration from the evaluated signals,”
see the proposed combination yielded in re claim 20 above.
In re claim 3, the proposed combination yields (all mapping directed to Barnes unless otherwise stated) wherein the radiation source for generating terahertz radiation (b) is designed to radiate a frequency-modulated or pulse-modulated terahertz radiation ([0137]: THz radiation can have a narrow range of frequencies, and is determined by the frequencies of a laser, therefore radiates a frequency-modulated terahertz radiation).
In re claim 6, the proposed combination yields (all mapping directed to Barnes unless otherwise stated) wherein the unit for acquiring reflected terahertz radiation from the body region to be examined is designed to acquire a broadband spectrum in the terahertz range within a frequency range from approximately 0.12 mm to approximately 5 mm (corresponding to 60 GHz to approximately 2.5 THz) ([0136]: THz range can include 100 GHz to 50 THz, which would include the range 60 GHz to 2.5THz).
Additionally, even if the proposed combination fails to yield a frequency range from approximately 0.12 mm to approximately 5 mm (corresponding to 60 GHz to approximately 2.5 THz), it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the unit for acquiring reflected terahertz radiation from the body region to be examined is designed to acquire a broadband spectrum in the terahertz range within a frequency range from approximately 0.12 mm to approximately 5 mm (corresponding to 60 GHz to approximately 2.5 THz), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 8, the proposed combination yields (all mapping directed to Barnes unless otherwise stated) wherein the unit for acquiring reflected terahertz radiation from the body region to be examined is designed for combined acquisition of reflected terahertz radiation from the body region to be examined (see in re claim 1 and [0138] where terahertz radiation can be reflected) and terahertz radiation radiated into the body region to be examined ([0138]: terahertz radiation can be absorbed and penetrates deeply into tissue where parts of the terahertz radiation reflect at different types/layers of tissues)
In re claim 12, the proposed combination yields (all mapping directed to Gerlitz unless otherwise stated)
wherein the IR acquisition unit comprises
at least one first sensor (fig. 5: one of the detectors 56)
at least one second sensor (fig. 5: another one of the detectors 56),
the first sensor being designed for acquiring IR radiation of
a first wavelength (see in re claim 20 above) or
a first wavelength range
in the region from approximately 8 µm to approximately 12 µm (see the proposed combination yielded in re claim 20 above),
where the intensity of the body's own IR radiation is substantially independent of the glucose concentration ([see in re claim 20 above),
the second sensor being designed for acquiring IR radiation of
a second wavelength (see in re claim 20 above) or
a second wavelength range
in the region from approximately 8 µm to approximately 12 µm (see the proposed combination yielded in re claim 20 above),
where the intensity of the body's own IR radiation changes in a manner dependent on the glucose concentration (see in re claim 20 above).
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the first sensor being designed for acquiring IR radiation of a first wavelength or a first wavelength range in the region from approximately 8 µm to approximately 12 µm and the second sensor being designed for acquiring IR radiation of a second wavelength or a second wavelength range in the region from approximately 8 µm to approximately 12 µm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 13, the proposed combination yields (all mapping directed to Gerlitz unless otherwise stated) wherein the IR acquisition unit comprises two or more second sensors which are designed for acquiring IR radiation of different wavelengths or wavelength ranges (see in re claim 12 above), where the intensity of the body's own IR radiation changes in a manner dependent on the glucose concentration (see in re claim 20 above).
In re claim 15, the proposed combination yields wherein a temperature is provided in the acquisition unit (c) which is at least 5°C cooler than the temperature of the body region to be examined (see in re claim 20, where Gerlitz teaches system 38 including Peltier 92 which cools the temperature in the system, and would be colder than the temperature of a finger). Further, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein a temperature is provided in the acquisition unit (c) which is at least 5°C cooler than the temperature of the body region to be examined. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed temperature provided in the acquisition unit (c) is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield wherein a temperature is provided in the acquisition unit (c) which is at least 5°C cooler than the temperature of the body region to be examined, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the proposed combination yields wherein a temperature is provided in the acquisition unit (c) which is at least 5°C cooler than the temperature of the body region to be examined, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 16, the proposed combination yields wherein the device is configured to
acquire initially the body's own IR radiation without irradiation of the body region to be examined being performed (see in re claim 20 above), and
subsequently irradiate the body region to be examined, with terahertz radiation (see the proposed combination yielded in re claim 20 above: Barnes: [0048, 0136]), and then to acquire the reflected terahertz radiation (see the proposed combination yielded in re claim 2- above, Barnes: [0084]: processor fuses hyperspectral image with information from the THZ sensor; Barnes: [0204]: images from different sensors and different times are merged together).
In re claim 17, the proposed combination yields wherein the evaluation unit is provided for temperature-compensated evaluation of the signals based on temperature values measured (see in re claim 20 above) and set by elements (d) (see in re claim 1 and 20 above) and/or (e) (see in re claim 1 and 20 above).
In re claim 18, regarding the limitation, “wherein the evaluation unit is provided for combined evaluation of the signals from the unit for acquiring reflected terahertz radiation from the body region to be examined and the IR acquisition unit for acquiring the body's own IR radiation from the body region to be examined and information from the THZ sensor is used to determine glucose concentration”, see the proposed combination yielded in re claim 20 above, wherein the IR acquisition unit of Gerlitz is combined with the unit for acquiring reflected terahertz radiation from the body region to be examined of Barnes, and wherein the information of both is used to determine glucose concentration.
In re claim 22, the proposed combination yields wherein the radiation source is capable of generating terahertz radiation in a wavelength region from approximately 0.12 mm to approximately 5 mm (Barnes: [0088]: THZ band ranges from about 100 μm to about 1 mm, which partially overlaps with 0.12 mm to approximately 5 mm).
Even if the propose combination fails to yield wherein the radiation source is capable of generating terahertz radiation in a wavelength region from approximately 0.12 mm to approximately 5 mm, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the radiation source is capable of generating terahertz radiation in a wavelength region from approximately 0.12 mm to approximately 5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 23, the proposed combination yields (all mapping directed to Barnes unless otherwise stated) wherein the radiation source is capable of generating terahertz radiation in a wavelength region from approximately 0.1 mm to approximately 1 mm ([0088]: THZ band ranges from about 100 μm to about 1 mm, which partially overlaps with 0.1 mm to approximately 1 mm).
Even if the propose combination fails to yield wherein the radiation source is capable of generating terahertz radiation in a wavelength region from approximately 0.1 mm to approximately 1 mm, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the radiation source is capable of generating terahertz radiation in a wavelength region from approximately 0.1 mm to approximately 1 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 24, the proposed combination yields (all mapping directed to Gerlitz unless otherwise stated) wherein the IR acquisition unit is also capable of unspecific acquisition of the body's own IR radiation [0041].
In re claim 25, the proposed combination yields (all mapping directed to Gerlitz unless otherwise stated) wherein the unit for measuring temperature in the body region to be examined (fig. 5: IR detector 56 measures body surface temperature; [0032]) further comprises an element for adjusting temperature in the body region to be examined ([0041]: Peltier element 82 provides desired amount of heat/cold and fan 84 provides heated/cooled air).
In re claim 28, the proposed combination yields wherein the unit for acquiring reflected terahertz radiation from the body region to be examined is designed for acquiring frequency-modulated and pulse- modulated signals (see in re claim 3 above where frequency modulated terahertz radiation is radiated, and therefore will result in frequency-modulated signals being acquired).
In re claim 30, the proposed combination yields (all mapping directed to Gerlitz unless otherwise stated) wherein the IR acquisition unit further comprises at least one third sensor (fig. 5: three IR detectors 56) being designed for referencing the body's own IR radiation [0036-0037].
Claims 2 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Gerlitz (US 2009/0259407) in view of Barnes et al. (US 2016/0080665) in view of Mandelis et al. (US 2007/0213607) in view of Mueller et al. (US 2007/0114418) in view of Kotter (US 2014/0231648).
In re claim 2, the proposed combination fails to yield wherein the radiation source for generating terahertz radiation (b) comprises an antenna.
Kotter teaches a radiation sensitive device [0002], which is analogous in relating to terahertz imaging [0002], and wherein a radiation source for generating terahertz radiation (b) [0030] comprises an antenna ([0024]: array of resonance elements i.e. antennas; [0030]: radiation source includes radiation that induce resonance of the resonance elements), in particular a patch [0007] or a dipole antenna [0007, 0037].
Kotter further teaches that antenna elements may be designed with various geometries and materials to cause different spectral responses [0007], and that the resonance elements (i.e. antennas) can be used to contribute to adjusting the resonant frequency into a desired terahertz range [0029].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the non-invasive sensing method yielded by the proposed combination, to provide wherein the radiation source for generating terahertz radiation (b) comprises an antenna, in particular a patch or a dipole antenna, as taught by Kotter, because doing so would allow for desired spectral responses as well as control over the desired terahertz range.
In re claim 27, regarding the limitation, “wherein the antenna is a patch or dipole antenna,” see in re claim 2 above.
Claims 4-5, 9-11, 14, 21, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Gerlitz (US 2009/0259407) in view of Barnes et al. (US 2016/0080665) in view of Mandelis et al. (US 2007/0213607) in view of Mueller et al. (US 2007/0114418) in view of Connor (US 2017/0164878).
In re claim 4, the proposed combination fails to yield wherein a focusing lens is arranged in a beam path between the radiation source for generating terahertz radiation (b) and the body region to be examined, the focusing lens consisting of a material that is substantially transparent for terahertz radiation.
Connor teaches an analogous non-invasive glucose monitoring device [0041], wherein a focusing lens [0418] is arranged in a beam path between the radiation source for generating radiation ([0042]: light emitter is interpreted as a radiation source since it emits energy towards a person’s body) and the body region to be examined ([0418]: lens can be placed between a light emitter and body tissue), the focusing lens consisting of a material that is substantially transparent for radiation ([0418]: inherent property of a lens to be transparent to the radiation being transmitted through it).
Connor further teaches that using a lens selectively refracts and focuses light [0418], and that using lenses can control the radiation’s frequency [0135], as well as the radiation’s projection and body incidence angle [0137], which provides more control over the radiation.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the non-invasive sensing method yielded by the proposed combination, to provide wherein the radiation source for generating terahertz radiation of Barnes includes a focusing lens in between the beam path between the radiation source and the body region to be examined, and wherein the focusing lens consisting of a material that is substantially transparent for terahertz radiation, as taught by Conner with the use of a transparent focusing lens placed in between the radiation source and the region of the body being examined, because doing so would allow for better control of the radiation, since the lens helps to focus the radiation’s path, frequency, and body incidence angle.
In re claim 5, the proposed combination yields wherein the focusing lens is designed to focus the radiation (see in re claim 4 above, and inherent property of a focusing lens), generated by the terahertz radiation source (b), on a predetermined zone of the body region to be examined containing capillary blood
(Barnes: [0135, 0138] THz radiation can penetrate several millimeters of tissue, which would include a zone containing capillary blood, especially if it’s capable of measure chemicals reflective of blood flow [0381]; combination in re claim 4 would allow the focusing lens taught by Conner to be in between the terahertz radiation source of Barnes, and allow the radiation to be targeted to a zone containing capillary blood, as taught by Barnes).
In re claim 9, the proposed combination fails to yield wherein the device does not contain an external source for generating IR radiation.
Connor teaches wherein the determination of the glucose is carried out by acquiring the body's own IR radiation ([0406-0408]: spectroscopic light energy sensors can collect data based on light reflected through tissue and is affected by glucose levels), without containing an external source for generating IR radiation ([0406-0408]: spectroscopic sensor can just comprise of a light receiver and use ambient light, therefore doesn’t require an external source of IR radiation; [0436]: ambient light source can be from solar radiation or artificial lighting).
Connor further teaches that using a spectroscopic light energy sensor provides information based on various body tissue, organs, and fluids [0452], which can be used to monitor glucose levels in those areas [0453], and that ambient light allows chemical composition of the person’s body tissue and fluid to be monitored [0409].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the non-invasive sensing method yielded by the proposed combination, to provide wherein the device does not contain an external source for generating IR radiation, as taught by Conner, because doing so would allow for ambient light that is generated from artificial lighting or from solar radiation to be used to monitor glucose concentration in various body tissue, organs, and fluids without the need of an external source of IR radiation.
In re claim 10, the proposed combination fails to yield wherein the unit for receiving the body region to be examined comprises an element which is thermally insulating, at least in part, with respect to the body radiation acquisition unit for acquiring radiation from the body region to be examined, and is intended for deposition of the body region to be examined.
Connor teaches wherein the unit for receiving the body region to be examined comprises an element which is thermally insulating ([0118-0119]: attachment member that spans a portion of a person’s arm that is examined can be a cuff and is attached with an enclosure, which would be thermally insulating), at least in part, with respect to a body radiation acquisition unit for receiving the body region to be examined for acquiring radiation ([0579]: attachment member such as a cuff is connected to a biometric sensor; [0116]: biometric sensor can be a spectroscopic sensor which measures reflected light), and is intended for deposition of the body region to be examined ([0119]: cuff will cover part of the person’s arm that is being examined).
Connor further teaches that this arrangement can help keep the sensors closer to the subject’s arm, and provide a more-consistent collection of data [0579].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the non-invasive sensing method yielded by the proposed combination, to provide wherein the unit for receiving the body region to be examined comprises an element which is thermally insulating, at least in part, with respect to the body radiation acquisition unit for receiving the body region to be examined, and is intended for deposition of the body region to be examined, as taught by Connor, because doing so would allow for