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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/10/2023, 09/19/2024, 02/18/2025, 05/01/2025, 07/18/2025 has been considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 limitations are:
• “first determination module” first recited in claim 32;
• “second determination module” first recited in claim 32;
• “arrangement module” first recited in claim 32;
• “measurement module” first recited in claim 32;
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for the “first determination module”, “second determination module”, “arrangement module”, and “measurement module” cannot be identified in the written description, only descriptions of the functional limitations are described in pars. [0246-0250]. The written description does note that the modules may be implemented as a hardware circuit or implemented by a mode of software in pars. [0352-0353] of the published specification, indicating that the modules are computer-implemented modules. The “first determination module”, “second determination module”, “arrangement module”, and “measurement module” are interpreted as computer-implemented software or hardware circuitry capable of carrying out their respective functional limitations and equivalents thereof.
It is noted that computer-implemented software or hardware circuitry is not capable of arranging a measurement probe at a position corresponding to the measurement region, therefore the corresponding structure for arrangement module cannot be found in the written description.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25, 32, and 85-87 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 25, the claim recites “a predetermined anti-jitter range”. The written description of the instant application does not provide sufficient detail to reasonably convey what an anti-jitter range is. Par. [0205] of the published specification indicates that a large-area photosensitive surface reduces the influence of jitter and pars. [0213, 0241] indicate that the photosensitive surface acquires a light intensity value within the predetermined anti-jitter range. Fig. 29 and par. [0361] describe skin jitter as a movement, however each recitation of the anti-jitter range is directed towards acquired light intensity or the size of the photosensitive surface. Based on these recitations, it is not reasonably conveyed what an anti-jitter range is, or how it may be implemented in a method.
Regarding claim 32, the claim recites “an arrangement module configured to arrange a measurement probe at a position corresponding to the measurement region”. However, par. [0352-0353] identify the modules in the application as being hardware circuits or implemented by software. Therefore, an arrangement module, as described in the written description would not contain the structure necessary to physically arrange a measurement probe at a position corresponding to the measurement region.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(a) are rejected by virtue of their dependency on a rejected base claim.
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 5, 16-17, 25, 27-28, 31-32, and 85-87 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.
Regarding claim 5, the claim recites “wherein a skin state at the measurement region meets a first predetermined condition… by the first fitting part; wherein a skin state at the measurement region meets a second predetermined condition… on the fixing seat; wherein a skin state at the measurement region meets a third predetermined condition… by the second fitting part”. However, claim 3, from which claim 5 depends, recites the fixing portion comprising a fixing seat and a first fitting part or a second fitting part. Therefore, the method of claim 3 does not require either the fixing seat and the first fitting part or the second fitting part. It is therefore indefinite how the a first, second, and third predetermined conditions can be simultaneously present without all three features present. Clarification is requested.
For the purposes of examination, the claim is interpreted similarly to the structure of claims 10, 13, and 17: “wherein a skin state at the measurement region meets one of: a first predetermined condition… by the first fitting part; a second predetermined condition… on the fixing seat; or a third predetermined condition… by the second fitting part.”
Regarding claim 16, the claim recites “determining a second posture positioning feature in response to a determination that the current measurement posture is not the target measurement posture, if the measurement probe is arranged at the position corresponding to the measurement region; and adjusting the current measurement posture to the target measurement posture according to the second posture positioning feature”. In claim 2, the step of adjusting a current measurement posture of a measured subject to a target measurement posture is a part of the “determining a measurement region according to the positioning feature” step recited in claim 1. Therefore, after this step, the measurement posture would be the target measurement posture, and this step occurs before the “arranging a measurement probe at a position corresponding to the measurement region” of claim 1. It is therefore unclear how the current measurement posture is not the target measurement posture if the measurement probe is arranged in the measurement region. Based on claims 1-2, the current measurement posture must be the target measurement posture when the measurement probe is arranged. Therefore it is unclear how the condition of “in response to a determination that the current measurement posture is not the target measurement posture, if the measurement probe is arranged at the position corresponding to the measurement region” in lines 2-4 can be met because if the current measurement posture is not the target measurement posture, then the “determining a measurement region according to the positioning feature” step cannot be completed, and subsequently the “arranging a measurement probe at a position corresponding to the measurement region has not been be completed.
Due to the indefiniteness of the conditions of claim 16, a prior art search is unable to be performed for claims 16 and 17.
Regarding claim 25, the claim recites “within a predetermined anti-jitter range” in line 3. It is unclear what defines an anti-jitter range, and therefore it is unclear what the metes and bounds of the claim are. It is understood from the specification that jitter is the movement of the measurement object, however it is unclear if the “jitter” refers to the amount of total movement of the measurement object relative to the probe over a period of time, the speed of movement, the magnitude of a maximum movement, etc. Therefore, it is indefinite what the predetermined anti-jitter range refers to. Clarification is requested.
For the purposes of examination, any range related to movement, related to movement over time, or related to displacement can be considered “a predetermined anti-jitter range”.
Regarding claim 27, the claim recites “the homogenous photosensitive surface” in line 2. There is insufficient antecedent basis for this limitation in the claim. Clarification is requested.
For the purposes of examination, “the homogenous photosensitive surface” is interpreted as “a homogenous photosensitive surface”.
Regarding claim 28, the claim recites “the photosensitive surface” in line 2. It is unclear which of the M photosensitive surfaces this refers to. Clarification is requested.
For the purposes of examination, the claim is interpreted as “one of the M photosensitive surfaces”.
Regarding claim 31, the claim recites “the photosensitive surface” in line 2. It is unclear which of the M photosensitive surfaces this refers to. Clarification is requested.
For the purposes of examination, the claim is interpreted as “one of the M photosensitive surfaces”.
Further regarding claim 31, the claim recites “an efficiency of the photosensitive surface receiving the exit light is greater than or equal to an efficiency threshold” in lines 3-4. It is unclear how the efficiency of the photosensitive surface is determined or measured. Clarification is requested.
For the purposes of examination, the “efficiency” is interpreted as any characteristic that affects the quality of the measured signal.
Regarding claim 32, it is unclear how the arrangement module carries out the functional limitations of “arranging a measurement probe at a position corresponding to the measurement region”, as the arrangement module has been identified as a hardware circuit or software implementation. It is unclear what structure to arrangement module is capable of these functional limitations. Clarification is requested.
For the purposes of examination, the arrangement module is interpreted as any hardware or software that may indicate where to arrange a measurement probe at a position corresponding to the measurement region.
Regarding claim 87, the claim recites “wherein the wearable apparatus causes a movement amplitude of a skin at the measurement region” in lines 1-2. It is unclear how the measurement apparatus causes a movement amplitude of a skin, as there is no recited structure such as an actuator, motor, or spring to induce movement of the skin. Clarification is requested.
For the purposes of examination the claim is interpreted as “wherein a movement amplitude of a skin at the measurement region is less than or equal to a movement amplitude threshold”.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 6,126,636 by Naka, hereinafter “Naka”.
Naka teaches a method of measuring a tissue element (Method shown in Fig. 6), comprising: determining a positioning feature (Fig. 6A-B; the positioning of the transparent sheet 2 over the palm traces determines the positioning of the probe); determining a measurement region according to the positioning feature (Fig. 6A-F; circle 2c determines the measurement region according to the positioning feature), wherein the measurement region meets a reproducibility of a measurement condition (Col. 1, lines 6-19; Col. 7, lines 61- Col. 8, line 3); arranging a measurement probe at a position corresponding to the measurement region (Fig. 6F); and performing a tissue element measurement by using the measurement probe (Col. 7, lines 53-60; “A first cycle of biodata measurement is performed with the measurement probe 11 received within the probe holder 6 then positioned on the hand palm in the manner described above and shown in FIG. 6F.”).
Claims 1, 32, and 85 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WIPO Patent Publication 2009/141769 by Liu, hereinafter “Liu (1)”.
Regarding claim 1, Liu (1) teaches a method of measuring a tissue element (Method shown in Fig. 6), comprising: determining a positioning feature (Fig. 6; Position selection and registration, step 20); determining a measurement region according to the positioning feature (Page 23, lines 21-25; The position registration determines the target location (i.e., measurement region)), wherein the measurement region meets a reproducibility of a measurement condition (Page 4, lines 21-28; The repositioning system allows for reproducible measurements.); arranging a measurement probe at a position corresponding to the measurement region (Fig. 6, Step 80, loading a sensing device at the target location); and performing a tissue element measurement by using the measurement probe (Fig. 6, Step 90 performing a measurement).
Regarding claim 32, Liu (1) teaches a method of measuring a tissue element that may be saved in a memory of control unit 22 (Page 26, lines 12-17) of repositioning system 10, therefore each of the steps as described above in the rejection of claim 1 can be considered a module. Therefore, Liu (1) teaches a device for measuring a tissue element according to claim 32.
Regarding claim 85, Figs. 9 and 10 of Liu (1) teach embodiments of the repositioning system. It is noted that a component of this system, such as sensing device 6, may be worn by placing it on the skin, thereby defining a wearable apparatus.
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 2-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Naka, as evidenced by US Patent Publication 2014/0171759 by White et al., hereinafter “White”.
Regarding claim 2, Naka teaches the method according to claim 1, wherein the positioning feature comprises a region positioning feature (Fig. 6A, circle 2c).
Naka does not teach the positioning feature comprising a first posture positioning feature, determining a measurement region according to the positioning feature comprises adjusting a current measurement posture of a measured object to a target measurement posture according to the first posture positioning feature; a target measurement posture meets the reproducibility of the measurement condition, and determining the measurement region according to the region positioning feature, in response to the current measurement posture being the target measurement posture.
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 the positioning feature to include a first posture positioning feature. This feature would be similar to the region positioning feature (i.e., comprising a duplication of parts), but would depict a target measurement posture instead of a position. A target measurement posture would be obvious to include at the effective filing date by one of ordinary skill in the art as White teaches that not only the position of the measurement region, but also the posture of the measured object (i.e., body part) affects the reproducibility of the measurement ([0150-0151]). It is further noted that 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. The modification to Naka would add another positioning feature corresponding to the posture (i.e., first posture positioning feature). No unexpected results would occur from the duplication of the positioning features.
Modified Naka does teach moving the measurement region (i.e., circle 2c) relative to the posture of a measured object (i.e., the body part). However, to reposition the first posture positioning feature relative to the measured object to achieve a target posture, the only possible way to achieve this are to move the measured object, as moving the feature would not affect the posture.
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 the method of Naka such that the measured object is adjusted relative to the first posture positioning feature and therefore the determining a measurement region according to the positioning feature comprises adjusting a current measurement posture of a measured object to a target measurement posture according to the first posture positioning feature; and determining the measurement region according to the region positioning feature, in response to the current measurement posture being the target measurement posture. This modification of the method of Naka would be obvious to try as adjusting the measured object is one of a finite number of identified, predictable solutions, with a reasonable expectation of success. See MPEP 2143.I.E.
Regarding claim 3, Naka teaches the method according to claim 2, wherein the arranging a measurement probe at a position corresponding to the measurement region comprises: arranging the measurement probe at the position corresponding to the measurement region by a fixing portion (Figs. 6D-F; probe holder 6), wherein the fixing portion is integrated with, partially separated from or completely separated from the measurement probe (the probe holder is separable from the measurement probe); wherein the fixing portion comprises a fixing seat (Fig. 6; recess 6c) and a first fitting part (cylindrical body 6a); and the arranging the measurement probe at the position corresponding to the measurement region by the fixing portion comprises: arranging the fixing seat at the position corresponding to the measurement region by the first fitting part (Fig. 6D, probe holder 6 is arranged at the position corresponding to the measurement region by aligning the first fitting part with the scope 1); and arranging the measurement probe on the fixing seat (Fig. 6F; the positioning pin 11d of the probe is arranged on the fixing seat 6c), or wherein the fixing portion comprises a second fitting part; and the arranging the measurement probe at the position corresponding to the measurement region by the fixing portion comprises: arranging the measurement probe at the position corresponding to the measurement region by the second fitting part.
Regarding claim 5, Naka teaches the method according to claim 3, wherein a skin state at the measurement region meets one of: a first predetermined condition in a process of arranging the fixing seat at the position corresponding to the measurement region by the first fitting part (Fig. 6D; The skin state can be defined as the skin being undeformed such that the pattern of the scope matches with the pattern on the skin when arranging the fixing seat via the first fitting part.); a second predetermined condition in a process of arranging the measurement probe on the fixing seat; or a third predetermined condition in a process of arranging the measurement probe at the position corresponding to the measurement region by the second fitting part.
Regarding claim 21, Naka teaches the method according to claim 3, further comprising: arranging the measurement probe on the fixing seat in response to a determination that the fixing seat is arranged at the position corresponding to the measurement region and the measurement probe is not arranged on the fixing portion (Figs. 6E-6F; Col. 7, lines 36-52; After the fixing portion (comprising the fixing seat) is arranged at the measurement region without the measurement probe, the measurement probe is arranged in the fixing seat (recess 6c)); or arranging the fixing seat at the position corresponding to the measurement region by the first fitting part and arranging the measurement probe on the fixing seat, in response to a determination that the fixing seat is not arranged at the position corresponding to the measurement region: or arranging the measurement probe at a position corresponding to the measurement region by the second fitting part, in response to a determination that the measurement probe is not arranged at the position corresponding to the measurement region.
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Naka in view of US Patent Publication 2012/0022347 by Liu et al., hereinafter “Liu (2)”.
Regarding claims 10 and 13, Naka teaches the method according to claim 3, wherein the determining the measurement region according to the region positioning feature comprises obtaining a first feature (determining the feature comprises choosing the part of the hand markings such that the measurement region is appropriate); adjusting, in response to a determination that the region positioning feature is not matched with the first feature, a position of the measurement probe and/or the fixing portion until the region positioning feature is matched with the first feature (Fig. 6D; Col. 7, lines 24-35; The probe holder 6 (i.e., fixing portion) is adjusted until the region positioning feature (circle 2c) is aligned with the first feature (the line on the palm corresponding to the first positioning feature)); and determining a region corresponding to the measurement probe and/or the fixing portion as the measurement region in response to a determination that the region positioning feature is matched with the first feature (When the region positioning feature (circle 2c with markings) and the first feature (palm lines) are in alignment, then the resulting region is the measurement region corresponding to the fixing portion (probe holder 6).), and wherein the adjusting a current measurement posture of a measured object to a target measurement posture according to the first posture positioning feature comprises obtaining a second feature (The feature coinciding with the first posture positioning feature); adjusting, in response to a determination that the first posture positioning feature is not matched with the second feature, the current measurement posture until the first posture positioning feature is matched with the second feature (See the rejection of claim 2); and determining that the current measurement posture is the target measurement posture, in response to a determination that the first posture positioning feature is matched with the second feature (See the rejection of claim 2).
Naka does not teach the first feature or second feature being a first projection feature and a second projection feature, however Naka does teach that the measured body part may be another body part other than a hand and the identifying marker (first feature and second feature) may be something other than palm lines.
Liu (2) teaches a method of determining a placement position for a measurement probe and indicating the target position on the skin. The location indication on the skin may be a projected image onto the skin ([0044]).
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 the first feature to be a first projection feature and the second feature to be a second projection feature, as taught by Liu (2). This combination comprises a simple substitution of one known element (using the palm lines or body part marking as a feature) for another (using a projected location indication as a feature) to obtain predictable results. See MPEP 2143.I.B.
Claims 23-24, 27-28, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Naka, as applied to claim 1, in view of US Patent Publication 2016/0091496 by Xu et al., hereinafter “Xu”.
Regarding claim 23, Naka teaches the method according to claim 1, wherein the performing a tissue element measurement by using the measurement probe comprises: irradiating a measurement region with incident light having at least one predetermined wavelength (Fig. 7 of Naka depicts an electro-optical bio-data measuring device connected to the probe, with a light source 22 providing a light output with a desired wavelength and a desired intensity), but does not teach wherein each beam of the incident light is incident on an incident position to form at least one beam of exit light exited from at least one exit position on the measurement region; obtaining a light intensity value corresponding to each beam of the exit light acquired by the measurement probe, so as to obtain T output light intensities, wherein the measurement probe comprises M photosensitive surfaces, each of the T output light intensities is obtained by processing the light intensity value of the exit light acquired by one or more of the M photosensitive surfaces, 1≤T≤M; and determining a concentration of a measured tissue element according to at least one output light intensity corresponding to the at least one predetermined wavelength.
Fig. 10a-b of Xu teaches a spectrometer configured to measure glucose ([0053]) with a fiber bundle 1001 configured to direct incident light onto a body. Fig. 10a also shows a plurality of bundles 1003, 1005, and 1007 configured to detect diffuse light at different intensities. The bundles 1003, 1005, and 1007 exit from end M, defining three photosensitive surfaces ([0133]). Figs. 9c depicts one beam of incident light diffusing different amounts through the samples and exiting at three positions, showing that the intensities of light extracted at each photosensitive surface are different ([0138]). The plurality of light intensities are used to calculate a blood glucose concentration ([0053, 0057]), and using a plurality of intensities can be used to remove various interferences, such as common-node interferences ([0052]). It is noted that the number of photosensitive surface equals the number of output light intensities (satisfying 1≤T≤M).
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 the method of Naka such that each beam of the incident light is incident on an incident position to form at least one beam of exit light exited from at least one exit position on the measurement region; obtaining a light intensity value corresponding to each beam of the exit light acquired by the measurement probe, so as to obtain T output light intensities, wherein the measurement probe comprises M photosensitive surfaces, each of the T output light intensities is obtained by processing the light intensity value of the exit light acquired by one or more of the M photosensitive surfaces, 1≤T≤M; and determining a concentration of a measured tissue element according to at least one output light intensity corresponding to the at least one predetermined wavelength, to remove various interferences such as common-node interference, as taught by Xu ([0052]).
Regarding claim 24, Naka in view of Xu teaches the method according to claim 23, wherein the determining a concentration of a measured tissue element according to at least one output light intensity corresponding to the at least one predetermined wavelength comprises: determining, for each predetermined wavelength in the at least one predetermined wavelength, a first output light intensity and a second output light intensity from at least two output light intensities corresponding to the predetermined wavelength (Xu, [0065]; The calculation of the blood glucose concentration using the probe as taught by Xu includes obtaining spectral data at a first and second radial position.); performing a differential processing on the first output light intensity and the second output light intensity corresponding to the predetermined wavelength, so as to obtain a differential signal (Xu, [0065-0068]; the calculation of blood glucose concentration comprises performing differential processing on the data from the first and second positions.); and determining the concentration of the measured tissue element according to the differential signal corresponding to each predetermined wavelength (Xu, [0164]; An effective glucose signal expression may be obtain by differential operation on equations).
Regarding claim 27, the claim teaches the method according to claim 23, further comprising: determining a total area of a homogeneous photosensitive surface according to a tissue structure feature in the measurement region (Xu, [0168]; the radial position of the floating reference position(s) are calculated, and the area defined by the outermost radial position defines an area), wherein the homogeneous photosensitive surface comprises the one or more photosensitive surfaces (the area comprises the three photosensitive surfaces), and the homogeneous photosensitive surface is configured to output one output light intensity (The light intensity of the first photosensitive area can be considered the one light intensity).
Regarding claim 28, Naka in view of Xu teaches the method according to claim 23, wherein a ratio of an area of each photosensitive surface to a circumference of the photosensitive surface is greater than or equal to a ratio threshold, wherein the ratio threshold is greater than or equal to 0.04 mm (Xu, [0168]; teaches that a radial position of 0.7-0.9, 1.3, and 1.8-2.0 mm may be chosen for the radial positions. These ranges would coincide with ratios of 0.35-0.45 mm, 0.65 mm, and 0.9-1 mm, respectively. While these ratios are not exact due to the inner areas of the photosensitive surfaces being variable, they are much larger than the ratio of 0.04 mm. Further, where the general conditions of a claim are disclosed in the prior art (the calculated ratios of area to circumference of the photosensitive surfaces), 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). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the ratio. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum ratio of area of photosensitive surface to the circumference of the photosensitive surface.
Regarding claim 31, Naka in view of Xu teaches the method according to claim 23, wherein a distance between the photosensitive surface and the surface of the measurement region (Naka teaches that the measurement probe contacts the tissue (i.e., measurement region)) is less than or equal to a distance threshold (because the distance is zero, it must be less than or equal to a distance threshold), and an efficiency of the photosensitive surface receiving the exit light is greater than or equal to an efficiency threshold (Xu; The photosensitive surfaces are used to remove various interferences such as common-node interference ([0052]), thereby defining an efficiency greater than a threshold of if the interferences were not removed).
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Naka in view of Xu, as applied to claim 23, in view of US Patent Publication 2017/0172476 by Schilthuizen, hereinafter “Schilthuizen”.
Regarding claims 25-26, Naka in view of Xu teaches the method according to claim 23, wherein each photosensitive surface is configured to acquire the light intensity value of the exit light exited from the exit position (Xu, [0052-0053, 0133]; See the rejection of claim 23) but does not teach the light intensities being within a predetermined anti-jitter range corresponding to the photosensitive surface, or wherein a ratio of an average optical path of the exit light received by each photosensitive surface in a target tissue layer to a total optical path is greater than or equal to a ratio threshold, and the total optical path is a total distance that the exit light travels in the measurement region.
Schilthuizen teaches a deformable element disposed between an optical sensor and the skin for securing the wearable device to the skin. This element allows for a stable interface with the skin, reducing motion and other artefacts and enabling stable assessment of physiological signals ([0038]). The received light corresponding to the amount of reduced motion between the skin and the sensor can be considered to be within a predetermined anti-jitter range.
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 the photosensitive surface in the method of Naka in view of Xu to include a deformable element such that the acquired light intensities are within a predetermined anti-jitter range corresponding to the photosensitive surface, to enable stable assessment of physiological signals, as taught by Schilthuizen ([0038]).
It is noted that the movement of the skin relative to the measurement probe affects the length of the optical path, as shown in Figs. 29 and 30 and described in par. [0038-0039] of the published specification of the instant application. The combination of Naka, Xu, and Schilthuizen teaches the reducing the motion between the measurement probe and the skin, thereby reducing the skin jitter relative to the measurement probe. This reduction also comprises wherein a ratio of an average optical path of the exit light received by each photosensitive surface in a target tissue layer to a total optical path is greater than or equal to a ratio threshold (the ratio threshold may be based on the amount of skin jitter, which is reduced), and the total optical path is a total distance that the exit light travels in the measurement region.
Claim 86 is rejected under 35 U.S.C. 103 as being unpatentable over Liu (1), as applied to claim 85, as evidenced by US Patent Publication 2018/0110466 by Ralston, hereinafter “Ralston” and Schilthuizen.
Liu (1) teaches the wearable apparatus according to claim 85, but does not teach wherein a mass of the wearable apparatus is less than or equal to a mass threshold, so that a movement pattern of the wearable apparatus is consistent with a skin jitter pattern at the measurement region. The wearable apparatus taught by Liu (1) must comprise a mass.
Ralston teaches that the motion of a sensor on a user’s skin can be minimized by reducing the mass of the sensor ([0093]). It is further noted that Schilthuizen teaches that reducing motion between the wearable apparatus and the skin enables stable assessment of physiological signals ([0038]). 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 the wearable apparatus of Liu (1) such that the a mass of the wearable apparatus is less than or equal to a mass threshold, so that a movement pattern of the wearable apparatus is consistent with a skin jitter pattern at the measurement region.
Claim 87 is rejected under 35 U.S.C. 103 as being unpatentable over Liu (1), as applied to claim 85, in view of Schilthuizen.
Liu (1) teaches the wearable apparatus according to claim 85, but does not teach wherein the wearable apparatus causes a movement amplitude of a skin at the measurement region to be less than or equal to a movement amplitude threshold.
Schilthuizen teaches a deformable element for securing the wearable device to the skin. This element allows for a stable interface with the skin, reducing motion and other artefacts and enabling stable assessment of physiological signals ([0038]). This reduced motion can be considered being less than or equal to a movement amplitude threshold.
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 the wearable apparatus of Liu (1) such that the wearable apparatus causes a movement amplitude of a skin at the measurement region to be less than or equal to a movement amplitude threshold, to enable stable assessment of physiological signals, as taught by Schilthuizen ([0038]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2005/0154382 by Altshuler et al. teaches a method of obtaining a positioning feature and using the feature to arrange a probe at a target position.
US Patent Publication 2019/0254605 by Lee teaches a device with positioning features to be matched with markers on a measured object indicating the position of a region to be measured. A measurement probe is positioned and a tissue element measurement is performed.
US Patent Publication 2005/0085718 by Shahidi teaches a method of positioning a tool relative to a target position by imaging the region and projecting a laser on the target position, and adjusting the tool until the tool is in place.
US Patent Publication 2005/0010090 by Acosta et al. teaches a spectroscope that is positioned onto a sampling site via a guide onto a preferred orientation of an arm to allow for reproducible measurements.
US Patent Publication 2016/0249836 by Gulati et al. – cited by Applicant, teaches a method of using a spectroscope with radial detectors to control the optical path of the reflected light.
US Patent 6,631,282 by Rule et al. teaches a guide device (i.e., fixing portion) with locating features to guide a measurement probe to be in aligned with a target region.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791