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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/21/2026 has been entered.
Claims Accounting
Applicant' s arguments, filed 01/21/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 01/21/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-3, 8-9, 11, and 18-19 have been amended.
Claim 20 is newly presented.
Claims 1-20 are the current claims hereby under examination.
Claim Objections
Claims 14 and 20 are objected to because of the following informalities:
Claim 14 recites “claim 13,further comprising” in lines 2. This should read “claim 13, further comprising”.
Claim 20 recites “one of an FT-IR spectroscope…” in line 2. Before the use of acronyms, the word/phrase should be fully written followed by the acronym. This should read “one of a Fourier Transform Infrared (FT-IR) spectroscope…”
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.
Claims 8 and 20 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.
Regarding claim 8, the claim recites “wherein the spectroscope is configured to separate a radiation spectrum incident on the light reception element into spectral components” in lines 2-3. It is unclear how this recitation further limits the device of claim 4. Based on the claim construction of claim 1 where the spectroscope is first recited, the spectroscope is not recited as being part of the biological information acquisition device (i.e., the device is not recited as comprising the spectroscope). Therefore, the limitation of “the spectroscope” is not a claimed element of the device of claim 4, and any further limitations relating to the spectroscope does not impart any structure onto the device of claim 4.
Regarding claim 20, the claim recites “wherein the spectroscope corresponds to…” in line 2. It is unclear how this further limitation of the spectroscope imparts any structure or further limits the biological information acquisition device of claim 1 for the same reasons as stated in relation to claim 8.
For the purposes of examination, the any claim meeting the limitations of claims 4 and 1 will read on the claim limitations of claims 8 and 20, respectively.
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 1-8 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims 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 19 follows.
STEP 1
Regarding claim 19, the claim recites a of method comprising the steps of measuring a radiation spectrum and acquiring biological information on a basis of a plurality of measurement results. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of acquiring biological information based on a plurality of measurement results sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The acquisition of the biological information does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the acquired biological information, nor does the method use a particular machine to perform the Abstract Idea. It is noted that the light reception element, as claimed, is analogous to a generic optical sensor and the circuitry is analogous to a generic circuit configured to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites an additional step of measuring a radiation spectrum emitted from a measurement part via an optical fiber. Measuring a radiation spectrum is well-understood, routine and conventional activity for those in the field of medical diagnostics. This step is recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional element fails to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Independent claims 1 and 18 recite a generic circuits (i.e., generic computer component) performing acquiring of biological information step of claim 19. MPEP 2106.05(f) states that implementing an Abstract Idea or other judicial exception on a computer does not make the claim patent-eligible.
The dependent claims 2-8, 17, and 20 also fail to add something more to the abstract independent claim as they generally recite structure of the generic optical sensor that are well-known. The acquiring biological information step recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
It is noted that claims 9-16 are not rejected under 35 U.S.C. 101 as they recite a temperature control unit that control the temperature of the light reception element. This element, in combination with the limitations of claim 4, comprises a particular machine, and satisfies Step 2A, Prong Two of the Subject Matter Eligibility Analysis.
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 (i.e., changing from AIA to pre-AIA ) 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 1-2, 17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Publication 2004/0132171 by Rule et al. – previously cited (hereinafter “Rule”).
Regarding claim 1, Rule teaches a biological information acquisition device (Fig. 21, noninvasive system 500) comprising:
a light reception element (Fig. 21, [0181]; optical window assembly 12 and detectors 28 are considered the light reception element, optical window assembly 12 is a part of optical input 506) configured to measure a radiation spectrum ([0200]; “electromagnetic radiation E omitted by the body can enter said first wearable module 503 via the optical input 506) emitted from a measurement part (the radiation is emitted from a portion of the wearer’s body that contacts optical input 506); wherein the radiation spectrum emitted from the measurement part is introduced into a spectroscope (Fig. 21; The spectroscope is defined as second module 525) via an optical fiber (Fig. 21, [0202]; Fiber optic cable 550 receives electromagnetic radiation from the optical input 506 and transmits it to the spectroscope); and
circuitry (Fig. 21, [0185]; control system 512, which is generally similar to control system 30) configured to acquire biological information ([0047, 0116]; detecting the concentration of an analyte) based on a plurality of measurement results obtained from the light reception unit ([0116]; concentration of an analyte of interest can be determined by comparing the time-varying intensity profiles of the various measured wavelengths).
It is noted that the limitation of “the radiation spectrum emitted from the measurement part is introduced into a spectroscope via an optical fiber” does not impart any structure on the biological information acquisition device or the light reception element, as it is directed towards the radiation spectrum which is not a claimed element of the device. Therefore, any device meeting the limitations of a light reception element configured to measure a radiation spectrum emitted from a measurement part is capable of measuring any incident radiation spectrum on the light reception element.
Regarding claim 2, Rule teaches the biological information acquisition device according to claim 1, wherein the radiation spectrum is radiation from a plurality of measurement parts, and the plurality of measurement parts include the measurement part. The device of claim 1 is capable of measuring a plurality of measurement parts and therefore the radiation spectrum can contain radiation from a plurality of measurement parts (The radiation is obtained from portion 514 of the wearer’s body that is in contact with the optical input 506. There are more locations along portion 514 that can be used as measurement parts.).
Regarding claim 17, Rule teaches the biological information acquisition device according to claim 1, wherein the circuitry is further configured to acquire biological information based on differential signals from the plurality of measurement results. The concentration of an analyte (e.g. biological information) is determined by changes in the phase difference (e.g. differentials based on the plurality of measurement results) ([0122-0134] and [0135-0148]).
Regarding claim 19, Fig. 21 of Rule teaches a biological information acquisition method comprising: measuring, by a light reception element (Fig. 21, [0181]; Optical input 506 comprises window assembly 12 and detectors 28), a radiation spectrum emitted from a measurement part (Fig. 21, [0116]; Radiation travels through window assembly 12 and to detectors 28 are used to detect the infrared energy emitted by the material sample S in various desired wavelengths), wherein the radiation spectrum emitted from the measurement part is introduced into a spectroscope via an optical fiber (Fig. 21, [0202]; Fiber optic cable 550 receives electromagnetic radiation from the optical input and transmits it to the spectroscope (The spectroscope is defined as second module 525); and acquiring, by circuitry (Fig. 21, control system 511), biological information on based on a plurality of measurement results obtained from the light reception element ([0179, 0185]; The control system 511 is generally similar to control system 30, wherein “concentration of an analyte of interest can be determined by comparing the time-varying intensity profiles of the various measured wavelengths”).
Regarding claim 20, Rule teaches the biological acquisition device according to claim 1, wherein the spectroscope corresponds to one of an FT-IR spectroscope or a dispersive spectroscope. Par. [0148] of Rule teaches that “During analysis, the data can be separated by frequency (using Fourier transform or other techniques) and independent measurements of phase delay at each of the driving frequencies may be calculated. Once resolved, the two sets of phase delay data are processed to determine absorbance and analyte concentration.” As the spectrometer may use a Fourier transform to analyze the received radiation spectrum, thereby defining an FT-IR spectrometer.
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.
Claims 3-16 and 18 is rejected under 35 U.S.C. 103 as being unpatentable over Rule.
Regarding claim 3, Rule teaches the biological information acquisition device according to claim 2, but does not teach the device further comprising a plurality of light reception elements, wherein each of the light reception elements is associated with a corresponding measurement part of the plurality of measurement parts, and the plurality of light reception elements include the light reception element.
However, according to MPEP § 2144.04-VI-B, the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified Rule to include a plurality of light reception elements. The modification to Rule would increase the number of measurement parts that can be monitored, increasing the amount of biological information that can be monitored. In the combination, each of the plurality of light reception elements would be associated with a corresponding measurement part. No unexpected results would occur from the duplication of the light reception elements, and the plurality of light reception elements would include the light reception element.
Regarding claim 4, modified Rule teaches the biological information acquisition device according to claim 3, wherein the light reception element includes a thermal conductor (Fig. 21, [0049]; Cooling system 14 comprises surface 14b which is in thermally conductive relation to heat sink 18 and is therefore considered a thermal conductor).
Regarding claim 5, modified Rule teaches the biological information acquisition device according to claim 4, wherein the light reception element further includes an optical filter (Fig. 21, [0201]; filters 24).
Regarding claim 6, modified Rule teaches the biological information acquisition device according to claim 5, wherein the light reception unit is further configured to receive light transmitted through the optical filter (Fig. 21, [0051]; concentrators 26 concentrate the infrared energy E after it passes through the optical filters 24 before reaching the detectors 28. The detectors 28 are considered a part of the light reception element).
Regarding claim 7, modified Rule teaches the biological information acquisition device according to claim 5, wherein the light reception element further includes a lens (Fig. 21, collimator 22) that makes light incident on the optical filter. It is noted that in par. [0054] of the written description of the published instant application, Applicant defines the lens as “not particularly limited as long as the light incident on an optical filter 113 described later can be made substantially parallel.” Par. [0095] of Rule teaches: “The collimator 22 aligns the infrared energy E to propagate in a direction that is generally parallel to the longitudinal axis A-A of the mixer 20 and the collimator 22, so that the infrared energy E will strike the surface of the filters 24 at an angle as close to 90 degrees as possible.” Therefore, the collimator 22 of Rule is considered to be a lens.
Regarding claim 8, modified Rule teaches the biological information acquisition device according to claim 4, wherein the spectroscope (Fig. 21, [0200]; second module 525) is configured to separate a radiation spectrum incident on the light reception element into spectral components ([0101]; the array of filters separate the incident radiation by filtering in four separate bandpass wavelengths).
Regarding claim 9, modified Rule teaches the biological information acquisition device according to claim 4, further comprising a temperature control unit (Fig. 21; cooling system 14 and heater layer 34 of window assembly 12) configured to control temperature of the light reception element ([0073]; “It is contemplated that the cooling system 14, the heater layer 34, or both, can be operated to induce a desired time-varying temperature in the window assembly 12 to create an oscillating thermal gradient in the sample S”).
Regarding claim 10, modified Rule teaches the biological information acquisition device according to claim 9, wherein the control of the temperature is based on a Peltier effect ([0073]; the cooling system 14 is used for control of the temperature and the cooling system is preferably comprises a Peltier-type thermoelectric device.).
Regarding claim 11, modified Rule teaches the biological information acquisition device according to claim 10, wherein the plurality of measurement parts are arranged in a plane (The plurality of measurement parts can comprise a tissue such as a forearm ([0048]). Therefore multiple sites on the forearm can comprise a plane.) and the temperature control unit is positioned such that heat transfer occurs in a direction parallel to the plane including the plurality of measurement parts. As the heater layer is employed to heat the material sample S ([0049]), the heat transfer occurs in a direction parallel to longitudinal axis A-A (Fig. 1). This direction would be parallel to the measurement window 12 and parallel to a flat plan of measurement parts.
Regarding claim 12, modified Rule teaches the biological information acquisition device according to claim 9, wherein the temperature control unit in configured to change temperature over time ([0073]; cooling system 14 and the heater layer 34 can be operated to induce a time-varying temperature).
Regarding claim 13, modified Rule teaches the biological information acquisition device according to claim 12, wherein the temperature control unit is further configured to raise and lower temperature over time. An oscillating thermal gradient can be obtained by heating and cooling (i.e. raising and lowering the temperature) in a cyclic pattern ([0137]).
Regarding claim 14, modified Rule teaches the biological information acquisition device according to claim 13, further comprising a plurality of the temperature control units (the modification of claim 3 duplicated the light reception elements, which would result in a duplication in each of the component associated with a light reception element. Components associated with each light reception element includes the temperature control unit, as each light reception element comprises is associated with a temperature control unit).
It is noted that each of the temperature control units modified Rule is capable of varying the temperature, thereby adjusting the temperatures ([0073, 0137]). Therefore, each of the plurality of temperature control units is capable of being adjusted to a different temperature, and the plurality of temperature control units includes the temperature control unit.
Regarding claim 15, modified Rule teaches the biological information acquisition device according to claim 9, wherein the control of the temperature is based on adjustment of a current flowing through the temperature control unit. Current drivers 78 are a part of the control system 30 (and thereby the control system 511) and regulate the power ([0055, 0073]; via an electrical current) supplied to the heater layer 34 and/or to the cooling system 14 in the temperature control subsystem based on adjustments to the control signal(s) ([0108]).
Regarding claim 16, modified Rule teaches the biological information acquisition device according to claim 15, wherein a constant current circuit is configured to ([0108]; current driver 78 in the temperature control subsystem of the control system 30 (and thereby control system 511)) adjust the current flowing through the temperature control unit (See the rejection of claim 15).
Regarding claim 18, Rule teaches a biological information acquisition system, comprising: a plurality of light reception elements configured to measure a radiation spectrum emitted from a plurality of measurement parts (See the rejections of claims 1-3), wherein the radiation spectrum emitted from each of the plurality of measurement parts is introduced to into a spectroscope via an optical fiber (See the rejection of claim 1); and circuitry configured to acquire biological information based on a plurality of measurement results obtained from the plurality of light reception elements (See the rejection of claims 1-3).
It is noted that a plurality of measurement results would be obtained from each of the plurality of light reception elements. Biological information is obtained from each of the plurality of measurement results of the plurality of light reception elements. This set of biological information can simply be considered biological information.
Response to Arguments
Applicant's arguments filed 01/21/2026 have been fully considered.
The amendments to claims 9 and 19 overcome the objections of record.
The amendments to the claims overcome the rejections under 35 U.S.C. 112(b) of claims 3 and 11.
Applicant’s assertion regarding the rejection of claim 1 under 35 U.S.C. 102 is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2020/0305783 by Baker et al. teaches a device configured to receive a radiation spectrum from a measurement part, comprising a light reception element and a Peltier-type heat thermal conductor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON A GLOVER whose telephone number is (571)270-0971. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791