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 .
Claims Accounting
Applicant's arguments, filed 03/02/2026, 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 03/02/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 5, 25, 27-28, and 31-32 have been amended.
Claim 2 has been cancelled.
Claims 1, 3, 5, 10, 13, 16-17, 21, 23-28, 31-32, and 85-87 are the current claims hereby under examination.
Claim Objections
Claim 32 is objected to because of the following informalities:
Claim 32 recites “adjustment unit configured to adjusting a current” in line 13. This should read “adjustment unit configured to adjust a current”.
Claim 32 recites “determination unit configured to determining the measurement” in line 13. This should read “determination unit configured to determine the measurement”.
Appropriate correction is required.
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”, 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”, and “measurement module” are interpreted as computer-implemented software or hardware circuitry capable of carrying out their respective functional limitations and equivalents thereof.
The corresponding structure of the “arrangement module” is identified as the fixing portion, as the corresponding functional limitations are described in par. [0255]. The “arrangement module” is interpreted as the fixing portion and equivalents thereof.
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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 25, the claim recites “the predetermined anti-jitter range represents a range of skin tissue at the measurement region corresponding to the photosensitive surface, the predetermined anti-jitter range satisfies that a relative change amount or a standard deviation of light intensity values of the exit light received by the photosensitive surface within one pulse period is less than a preset value” in lines 4-7. While the intended effect of the condition caused by the skin tissue is clear (to satisfy that a relative change amount or a standard deviation of light intensity values of the exit light received by the photosensitive surface within one pulse period is less than a preset value), it is unclear the metes and bounds of the limitation. The limitation “a range of skin tissue” can refer to characteristics of skin tissue that may result in the resulting effect such as different types of skin tissue, a state of a skin tissue (i.e., movement of a skin tissue), or another property of skin tissue. Clarification is requested.
For the purposes of examination, any characteristic of skin that may result in a relative change amount or a standard deviation of light intensity values of the exit light received by the photosensitive surface within one pulse period is less than a preset value can be considered “a predetermined anti-jitter range”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3, 5, 10, 13, 16-17, and 21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 recites “The method according to claim 2” in line 1. As claim 2 has been cancelled, claim 3 is not in proper dependent form, as it is not dependent on a preceding claim. Amending the preamble of claim 3 to read “The method according to claim 1” would obviate the rejections under 35 U.S.C. 112(d), as claim 1 contains the limitations of original claim 2.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(d) are rejected by virtue of their dependency on a rejected base claim.
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 1, 3, 5 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 6,126,636 by Naka – previously cited, as evidenced by US Patent Publication 2014/0171759 by White et al. – previously cited, hereinafter “White”.
Regarding claim 1, 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.”), 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 in view of White does not 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 is 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 in view of White 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 in view of White 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 in view of White teaches the method according to claim 1, 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 (Naka; 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 (Naka; Fig. 6; recess 6c) and a first fitting part (Naka; 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 (Naka; 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 (Naka; 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 in view of White teaches the method according to claim 3, wherein a skin state of a skin 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 (Naka; 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 in view of White 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 (Naka; 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 (Naka; 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 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 – previously cited, hereinafter “Liu (1)” in view of White.
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), wherein the positioning feature comprises a region positioning feature (Fig. 5; the marker 12 denotes the target for measurement); but 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 Liu (1) 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 Liu (1) in view of White does not teach moving the measurement region (i.e., target 12) 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 is 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 Liu (1) in view of White 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 Liu (1) in view of White 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 32, Liu (1) in view of White 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 (capable of arranging and adjusting the arrangement of the measurement probe to the target location), 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) in view of White 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.
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Naka in view of White, as applied to claim 3, in view of US Patent Publication 2012/0022347 by Liu et al. – previously cited, hereinafter “Liu (2)”.
Regarding claims 10 and 13, Naka in view of White 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 (Naka; Fig. 6D; Col. 7, lines 24-35; The probe holder 6 (i.e., fixing portion) is adjusted until the region positioning feature (Naka; circle 2c) is aligned with the first feature (Naka; 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 (Naka; 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 1); 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 1).
Naka in view of White 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 in view of White, as applied to claim 1, in view of US Patent Publication 2016/0091496 by Xu et al. – previously cited, hereinafter “Xu”.
Regarding claim 23, Naka in view of White 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 in view of White 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, the combination of Naka, White, and 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 combination of Naka, White, and Xu 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, the combination of Naka, White, and Xu teaches the method according to claim 23, wherein for any one of the M photosensitive surfaces, 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, the combination of Naka, White, and Xu teaches the method according to claim 23, wherein for any one of the M photosensitive surfaces, 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 White in view of Xu, as applied to claim 23, in view of US Patent Publication 2017/0172476 by Schilthuizen – previously cited, hereinafter “Schilthuizen”.
Regarding claims 25-26, the combination of Naka, White, and 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, the predetermined anti-jitter range represents a range of skin tissue at the measurement region corresponding to the photosensitive surface, the predetermined anti-jitter range satisfies that a relative change amount or a standard deviation of light intensity values of the exit light received by the photosensitive surface within one pulse period is less than a preset value, 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 the combination of Naka, White, and 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, White, 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. It is further noted that the photosensitive surface is configured to measure exit light when the skin is not moving at all, which would be below any preset value related to the movement of the skin.
Claim 86 is rejected under 35 U.S.C. 103 as being unpatentable over Liu (1) in view of White, as applied to claim 85, as evidenced by US Patent Publication 2018/0110466 by Ralston – previously cited, hereinafter “Ralston” and Schilthuizen.
Liu (1) in view of White 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) in view of White 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) in view of White 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) in view of White, as applied to claim 85, in view of Schilthuizen.
Liu (1) in view of White 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) in view of White 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]).
Allowable Subject Matter
Claims 16-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 16 recites: the method of according to claim 3, further comprising: determining a second 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.
The closest prior art is identified as the combination of Naka in view of White as applied to claim 3 above. The combination of Naka and White teaches the method of claim 3, but does not teach the method further comprising: determining a second 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. Naka in view of White relies on setting the measurement posture according to the posture positioning feature prior to determining the measurement region, but does not teach determining a second posture positioning feature. The teachings of White are relied upon to teach using a registration point in relation to the posture of the user, but teaches the registration point is coupled to the positioning feature. No reference containing a teaching that would provide one of ordinary skill in the art at the time of the effective filing date with a motivation to modify the method of Naka in view of White to meet the claim limitations of claim 16 were found in a prior art search.
The limitations of claim 16, and all claims that depend therefrom, are patentably distinct over the prior art cited in this Office action and any other prior art.
Response to Arguments
Applicant’s arguments, filed 03/02/2026, have been fully considered.
Applicant’s arguments that the interpretation of the arrangement module should be analogous to the fixing portion are acknowledged. This argument is found persuasive. The interpretation under 35 U.S.C. 112(f) of the arrangement module no longer results in a rejection under 35 U.S.C. 112(a) or 112(b).
Applicant’s arguments regarding the rejection of claim 25 under 35 U.S.C. 112(a) is acknowledged. Applicant’s arguments and the amendments to the claims obviate the rejection under 35 U.S.C. 112(a). However, the amended claim language of claim 25 necessitates a new rejection under 35 U.S.C. 112(a).
Applicant’s arguments regarding the rejections of record of claims 16-17, 31, and 87 under 35 U.S.C. 112(b) are acknowledged. These arguments are found persuasive, and the rejections are hereby withdrawn.
The amendments to the claims overcome the rejections of record of claims 27-28 and 31-32 under 35 U.S.C. 112(b).
Applicant’s arguments regarding the rejection of amended claim 1 under 35 U.S.C. 103 are acknowledged.
Applicant argues that the White reference simply suggests that posture may affect the sample measurement, and that the teaching in the White reference is a general problem identification and does not provide a specific solution on how to integrate positioning of measurement posture into Naka’s physical marking system. This argument is not found persuasive. The teachings of White cited in this Office action and the Non-final Office action are directed towards par. [0150-0151], wherein White describes solutions to set the proper angle between the upper arm (i.e., posture of the upper arm) and the sampling head, including a registration point for the arm in par. [0150]. White also teaches that alternatively to the cradle, a positioning device can include an optically transparent film in par. [0151]. Therefore, White sets forth a positioning system capable of setting the proper angle between the upper arm and -sampling head (i.e., posture) comprising a registration point (i.e., positioning feature) and teaches a positioning system comprising an optically transparent film, similar to that of Naka.
Applicant argues that the combination of Naka and White would not comprise limitations of determining the measurement region in response to the current measurement posture being the target measurement posture. This argument is not found persuasive. White teaches an apparatus and methods for its use to set the proper angle between the upper arm and the sampling head. The positioning of the upper arm must be completed prior to the determination of the measurement position, because the opening for the sample head is located in the cradle or positioning device. Therefore, the posture must be determined before the measurement region can be determined.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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