DETAILED ACTION
Final Rejection
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 Status
Claims 1 2 are amended. Claims 22-26 are cancelled. Claims 1-21 remain pending.
Response to Arguments
The 35 US 101 rejections of claims 22 and 23 are withdrawn in view of the cancellation of the claim.
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. Applicant argues that claim 1, as now amended, recites specific structural elements, specific operations that can only be performed on computing devices, specific data manipulations that cannot be practically performed in the human and provides a physical output that cannot, in any manner, be performed by a human person. Claim 1 has been amended to include the limitation that a hydration rank is determined. This limitation that is recited in the body of the claim was interpreted as a mental process as there are not limitations that indicate that this cannot be performed mentally. The recitation of a processor to perform the step was interpreted as mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). The recitation of outputting an indication of the hydration status on a display was interpreted as insignificant post solution activity. Applicants also argue that the claim “clearly recites an inventive concept as described in step 2B of the guidance” but does not include any analysis to support this assertion. Without more it is difficult for the Office to assess this line of argument. The 35 USC 101 rejections of claims 1-21 are maintained.
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive in part. The Office believes that some of the amendments to claim 1 are still taught by the primary references. In addition, newly added limitations referencing the correlation of the hydration rank scale to a clinical hydration category can be found in other analogous art references as explained in the new rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-21 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.
Claim 1 recites the limitation "the memory" in line 10. There is insufficient antecedent basis for this limitation in the claim. The Office suggests amending the claim to recite “a non-transitory computer readable memory.”
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 8 and 9 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. The limitations of claims 8 and 9 appear to already be covered by the output step at the end of claim 1. 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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recite(s) a step of determining, from the quantitative hydration parameter, a hydration rank indicative of a hydration status of the user on a hydration rank scale correlated with clinical hydration categories. A claim may recite an abstract idea and still be eligible under 35 USC 101 if there are any additional elements recited in the claim beyond the judicial exception if they integrate the exception into a practical application of the exception under Step 2A Prong Two of the 2019 Revised Patent Subject Matter Eligibility Guidance published by the USPTO. In this case, claim 1 includes a limitation that can be interpreted as applying/relying on/using the judicial exception (outputting on a display of the wearable device an indication of the hydration status). This limitation however amounts to necessary data outputting (MPEP 2106.05(g) which does not impose a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. A claim may still be patent eligible under the Step 2B analysis if the claim recites additional elements that amount to significantly more than the judicial exception. Method claim 1 also recites the acquisition of spectral data using an optical sensing module of a wearable device. While the claim does reference non-abstract hardware used in the method, the Office finds that these limitations are arguably extra-solution data gathering using conventional hardware. Method claim 1 also recites the use of a processor to perform signal processing functions including applying a baseline correction to obtain a delta spectrum. This step was also interpreted as appending well-understood activities to the judicial exception. Claims 2-7, 15-17, 21 amount to additional abstract details. Claims 8, 9 amount to conventional well understood activities (outputting data). Claims 10-12 reference an optical sensor/laser(s) that amounts to appending well-understood structures. Claims 13, 14, 18-20 amount to extra-solution
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 9-16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bandic et al. (US 2010/0185064, cited previously) in view of Rymut (US 2013/0144136).
Regarding claim 1, Bandic et al. disclose a computer-implemented method for determining a hydration status of a user (Abstract reference to a device for detecting skin characteristics, the device being connected to a computer, [0222] reference to a computer algorithm for performing the processing, [0235] discussion of computer analysis of the data collected by imaging sensor) the computer-implemented method comprising:
acquiring, by an optical sensing module ([0070] – “a host subsystem comprising an illumination module for directing polarized and unpolarized light (or electromagnetic signals) to physiological organs, a sensor module for capturing the polarized and unpolarized electromagnetic signals reflected from the physiological organs”) of a wearable device ([0056] –“ The device may be wearable by the user”) in contact with a body tissue of the user (Fig. 96), a spectral data representing a body-tissue absorption spectrum (see at least [0018] –“The problem of generating a skin condition assessment in real-time is solved by having a skin condition analysis module capable of doing real-time analysis of digital skin data, acquired partly using diffused reflectance spectroscopy”), the optical sensing module comprising a photonic integrated circuit comprising a plurality of light sources (Fig. 1, #108+127; configured to sequentially emit light at a plurality of wavelengths ([0227] – “The device 108 may be adapted to emit more than one type of light and may be able to switch among or combine various light sources 127”) and a photodetector array configured to receive light backscattered from the skin ([0022] – “system may further comprise a sensor for capturing an image of the reflected or re-emitted light” – image indicating an array; see also [0071] – “a sensor subsystem for capturing the polarized and unpolarized electromagnetic signals absorbed, reflected and re-emitted from the physiological organs”; see also [0234] for light sensor details);
executing, by a processor (Fig. 1, #104) of the wearable device coupled to the optical sensing module and the memory ([0056] – “The device may further include a memory”, memory would be connected to host hardware which includes light source and sensor 108)), instructions that cause the processor to:
apply a baseline correction to the spectral data using the baseline spectral data to generate a delta spectrum (delta spectrum was interpreted in view of the specification as including a process whereby baseline spectral data is subtracted from the acquired spectral data, subtraction yielding a “delta” or difference spectrum; in Bandic, there are several disclosures where spectral data is subtracted from spectral data including, for example, [0302], [0317], [0321], [0322]; a more relevant example is provided at [0326] – “The spectral signature may further be enhanced by subtracting the spectral contribution attributable to the source light from the reflected light spectrum in order to normalize the spectral signature to specific skin conditions … By subtracting the source spectral signature, the resulting spectral waveform is normalized to only the changes in the skin from the interaction with incident light. In this way, specific type of incident light may be used which may be more amenable to detecting certain structures, compositions, or conditions”);
determine from the delta spectrum a quantitative hydration parameter associated with absorption characteristics of the body tissue ([0728] states that the wearable hydration monitor or WHM is used to measure hydration level, algorithms in [0750] are used to help analyze spectral data obtained from the WHM, the spectral data being processed as noted in the previous section; [0316] describes a particular way light can be analyzed to assess hydration state); and
determine, from the quantitative hydration parameter, a hydration rank indicative of a hydration status of the user on a hydration rank scale (([0728] states that the wearable hydration monitor or WHM is used to measure hydration level, algorithms in [0750] are used to help analyze spectral data obtained from the WHM, [0316] describes a particular way light can be analyzed to assess hydration state and notes that the level maybe correlated to an expert grading scale); and
outputting, on a display of the wearable device or an external device, an indication of the hydration status corresponding to the hydration rank ([0019] – “The device may further comprise a user interface … In the device, skin assessment data of locations may be overlaid on an image of a larger skin region and displayed on the display surface.”).
Bandic does not disclose that the hydration rank scale is correlated with clinical hydration categories. As noted previously, Bandic discloses that the hydration level maybe correlated to an expert grading scale, but does not state that the expert scale is a clinical scale. However, Rymut teaches a method and apparatus for determining tissue hydration (Abstract). Rymut method and apparatus can provide a hydration index “defined as a single, dimensionless parameter that is scaled such that a patient's overall hydration status can be understood from its magnitude alone” ([0100]). The hydration index taught by Rymut incorporates a variety of inputs including physiological measurements and “a "gold standard" clinical assessment of overall hydration” (see [0100] and [0103]) that can be thresholded to indicate hydration levels and to guide medical care ([0102]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Bandic’s hydration level such that it is correlated with an expert scale such as a clinical one as taught by Rymut for categorizing hydration levels because it amounts to combining prior art elements according to known methods to yield predictable results. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Note: Although Bandic was cited as disclosing the application of a baseline correction to the spectral data, this technique was also known in the arts as exemplified by Yakimov reference (see attached).
Regarding claim 2, Bandic et al. as modified in view of Rymut teaches wherein each hydration rank on the hydration ranks scale maps onto a respective output of a standard clinical point of care test (as noted above, the hydration levels incorporate gold standard clinical hydration assessments that can be thresholded to indicate hydration levels, see at least [0102]). The rationale for modifying remains the same.
Regarding claim 3, Bandic et al. as modified above in view of Rymut do not disclose wherein the standard clinical point of care test is a test of urine osmolality, urine specific gravity, fluid gain, fluid loss, increases or decreases in body weight or mass representing fluid gain or fluid loss, respectively, or serum osmolality. However, Bandic et al. does teach that in some embodiments for assessing hydration state or dehydration, a degree of fluid loss can be incorporated into the hydration score (see [0752] and [0753). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify the hydration rank to include additional measures of hydration state such as fluid loss taught by Bandic et al. because it can improve hydration assessment.
Regarding claim 4, Bandic et al. as modified in view of Rymut teach wherein the hydration rank is a hydration index, and wherein the hydration index is a given value on a hydration index scale (see claim 1 rejection where Rymut is used to include clinical hydration assessments to provide a value indicative of levels of hydration).
Regarding claim 9, Bandic et al. disclose wherein the sensor is an optical sensing module (see at least [0022] – “The method and system may further comprise an optical facility for detecting reflected or re-emitted light from the skin. The method may determine both reflected or re-emitted light, and newly emitted light, through the process of absorption and re-emission”).
Regarding claim 10-11, Bandic et al. disclose wherein the sensor is an optical sensing module and the optical sensing module comprises a laser ([0233] – “Continuing to refer to FIG. 1, in an embodiment, the light source may be integral to the device 108 or provided from an associated source. The light source may be a light-emitting or laser diode (LED) of any wavelength”).
Regarding claim 12, Bandic et al. disclose wherein the optical sensing module comprises a plurality of lasers, each laser of the plurality of lasers operating at a wavelength that is different from the wavelength of the others ([0233] – “The light source may be a light-emitting or laser diode (LED) of any wavelength, such as and without limitation 280, 340, 360, 385, 405, 395, 400, or 480 nm incident excitation wavelengths, as well as infrared and near-infrared. Wavelengths in the ultraviolet and infrared ranges may also be emitted by the device 108. The light source may be diffusion light, white light, monochromatic light, light of multiple single wavelengths…”; multiple single wavelengths indicating the need for multiple laser diode sources).
Regarding claim 13, Bandic et al. disclose wherein the optical sensing module is configured to operate each laser one at a time ([0743] discusses hydration/moisture determination of skin and notes that, “this process may comprise one or more phases comprising emission of incident electromagnetic signals to skin, detection of degree of polarization of the electromagnetic signals reflected or re-emitted from skin and determination of the moisture levels based on the amount of polarized and reflected or re-emitted electromagnetic signals”, multiple emissions would therefore denote operating each laser one at a time).
Regarding claim 14, Bandic et al. disclose wherein the optical sensing module is configured to operate the plurality of lasers in a cycle according to a pre-determined schedule (based on the cited section in the claim 13 rejection above, operating the device for multiple emissions would inherently require a pre-determined cycle/schedule as one would not just randomly pull run the diagnostic device without a purpose).
Regarding claim 15, Bandic et al. disclose wherein the bodily parameter data is a body tissue absorption spectrum ([0022] – “In an aspect of the invention, a method and system of a non-invasive imaging device may comprise an illumination source comprising an incident light source to direct light upon skin; … The method and system may further comprise an optical facility for detecting reflected or re-emitted light from the skin. The method may determine both reflected or re-emitted light, and newly emitted light, through the process of absorption and re-emission”; [0474]- “As used herein, the term "spectrum analyzer" refers to a device used to examine the spectral composition of some … optical waveform. It may also measure the power spectrum. In general, there are three types of spectrum analyzers, such as analog, digital and real-time spectrum analyzers. Firstly, an analog spectrum analyzer uses either a variable band-pass filter whose mid-frequency is automatically tuned (i.e. shifted, swept) through the range of frequencies of the spectrum to be measured or a superheterodyne receiver, wherein the local oscillator is swept through a range of frequencies. Secondly, a digital spectrum analyzer computes the Discrete Fourier transform (or DFT), a mathematical process that transforms a waveform into the components of its frequency spectrum. Eventually, some spectrum analyzers, such as "real-time spectrum analyzers", use a hybrid technique where the incoming signal is first down- converted to a lower frequency using superheterodyne techniques and then analyzed using fast Fourier transformation (FFT) techniques.”).
Regarding claim 16, Bandic et al. disclose wherein the model includes a regression model [0785] – “According to an example, the optical analysis device further comprising a diffused reflectance unit for generating the predetermined set of wavelengths for reflection intensity measurement of the spectral data, utilizing the plurality of reflection intensity values and the plurality of reflection intensity ratio values of the spectral data for classification of the skin type responsive to generating a predetermined set of wavelengths, normalizing the reflection intensity values of spectral data with respect to spectral source and spectral classification of the skin type and generating a skin photo type output by applying nonparametric regression analysis on measured spectral data responsive to normalizing the reflection intensity values of spectral data”).
Regarding claim 18, Bandic et al. disclose the computer-implemented method further comprising: acquiring other sensor information in addition to the hydration information; and/or, acquiring user input information (see at least [0236] where user input is collected or [0244] where other sensor data such as BP or heart rate can be collected).
Regarding claim 19, Bandic et al. disclose wherein the other sensor information includes one or more of body temperature information obtained from a temperature sensor, activity information obtained from an accelerometer, heart rate information obtained from a heart rate sensor and blood pressure information obtained from a blood pressure sensor (See [0244).
Regarding claim 20, Bandic et al. disclose wherein the user input information includes one or more of weight information, activity information, diet information, fluid intake information, illness information and intoxication information (See at least [0059] reference to a diet tracking unit).
Regarding claim 21, Bandic et al. disclose the computer-implemented method, further comprising: storing a hydration status cause data table, the hydration status cause data table associating causes of a clinical hydration status with stored other sensor information and/or stored user input information respectively; and when a hydration rank is derived which indicates that the clinical hydration status of the user is a pre-determined clinical hydration status; comparing acquired other sensor information and/or user input information with stored other sensor information and/or stored user input information respectively and, based on this comparison; selecting a cause of a clinical hydration status, and outputting the selected cause of the clinical hydration status to the user ([0419] – “The user may be able to request More Information for each of the measures, such as why a certain condition is caused”; it would be inherent that parameter values would be stored in relation to cause(s)).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bandic et al. in view of Rymut as applied to claim 4/1 respectively and further in view of Goldman et al., Clinical dehydration scale appears valid, but its impact on clinical outcomes is not clear, Pediatrics 2008; 122:545-9, cited previously).
Regarding claim 5, Bandic et al. was modified in view of Rymut to include hydration rank that is correlated to clinical hydration categories in the rejection of claim 1. This modification however does not disclose wherein each hydration index on the hydration index scale maps onto a respective output of a standard clinical point of care test. However, there is an existing systemic dehydration scale referred to as the clinical dehydration scale. The scale disclosed in the Goldman reference is as follows: score 0 =no dehydration, score 1-4 = some dehydration, and score 5-8 = moderate/severe dehydration (see left col. of refence). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify Bandic’s method such that each hydration index value maps to a respective output of a standard point of care test such as that taught by Goldman as it amounts to combining prior art elements according to known methods to yield predictable results. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. There would have been a reasonable expectation of success as Bandic already discloses how to correlate to an expert scale.
Regarding claim 6, Bandic et al. as modified by Rymut do not disclose wherein the hydration index scale is sub-divided into a plurality of sub-ranges of hydration index values, each of the plurality of sub-ranges corresponding to a different clinical hydration status of the user, and wherein the method further comprises: determining which sub-range of the plurality of sub-ranges the hydration index value falls within (the modification in view of Rymut produces different levels of hydration related to a gold standard clinical assessment but it is does not necessarily break each level down to different clinical hydration levels – i.e. you can have several values in a range that cover one category). However, the modification in view of Goldman above satisfies this limitation (see subranges taught by Goldman cited above). The rationale for modifying remains the same.
Regarding claim 7, Bandic et al. as modified in view of Rymut does not disclose wherein the hydration rank is a clinical hydration status of the user. However, the modification in view of Goldman cited in the rejection of claim 5 would satisfy this limitation. The rationale for modifying remains the same.
Regarding claim 8, Bandic discloses the computer-implemented method further comprising :outputting the clinical hydration status of the user ([0220] – “The output of image processing can be either an image or a set of characteristics or parameters related to the image.” And [0056] – “The device may further include a display surface. The skin assessment data of locations may be overlaid on an image of a larger skin region and displayed on the display surface”).
Conclusion
Claims 1-21 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tho Q. Tran whose telephone number is (571)270-1892. The examiner can normally be reached 7-5.
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/THO Q TRAN/ Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791