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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02 April 2026 has been entered.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “light-emitting component” recited in Claims 1, 9, 12, and 16-17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Based on the specification, the examiner has interpreted “light-emitting component” to include structural elements that “include, but are not limited to, LEDs, micro LEDs, mini LEDs, laser diodes (LDs) (e.g., vertical cavity surface- emitting lasers (VCSELs), and the like” (Paragraph [0024]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 1-14 and 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they involve human tissue/parts.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 1 follows.
STEP 1
Regarding Claim 1, the claim recites a series of steps or acts, including collecting bodily fluid; transmitting light; generating one or more signals; and determining the concentration of the one or more substances within collected bodily fluid. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining the concentration of the one or more substances within collected bodily fluid set forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 fails to recite any application of determining the concentration of the one or more substances within collected bodily fluid in a manner that imposes a meaningful limitation on the Abstract Idea. The Abstract Idea alone does not provide an improvement to the technological field, the method does not affect a particular treatment or effect a particular change based on a detected concentration of one or more substances in the collected bodily fluid, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 1 recites additional steps of transmitting light using light-emitting components and generating, using a photodetector of the wearable device, one or more signals. Transmitting light using light-emitting components and using photodetectors to generate signals are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the transmitting and generating steps are recited at a high level of generality such that they amount to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the determining and receiving steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 16, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited fluid collection component is a generic fluid collection device configured to perform pre-solutional data gathering activity, as are the generically claimed one or more light-emitting diodes and photodetector. The controller is a computer system configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Dependent Claims 2-14, and 17-20 fail to add something more to the abstract independent claims as they generally recite generating signals as steps pertaining to data gathering and processing.
The collecting, transmitting, generating, and determining steps recited in the independent claims, Claims 1 and 16, maintain a high level of generality even when considered in combination with the dependent claims.
Claims 16-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claim 16, the applicant cannot claim parts of the human tissue and/or body. The applicant has claimed “attached to a finger of a user”. This element cannot be claimed since “a finger” is referring to a part of the body.
Claim16 improperly recites human tissue as part of the claimed invention. It is suggested that the applicant amend the claim to recite that “configured to be attached to a finger of the user” in order to remove the recitation of human tissue (emphasis added). Claims 17-20 are rejected due to their dependence on claim 16.
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, 8-14, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et. al.’120 (U.S. Patent Publication 20210290120) in view of Kam et. al.’080 (U.S. Patent 10105080), and further in view of Akutagawa et. al.’339 (U.S. Patent Publication 20200279339) as evidenced by Boukhayma et. al.'500 (U.S. Patent Publication 20220071500).
Regarding Claim 1, Al-Ali et. al.’120 discloses a method for fluid analysis (Paragraph [0347] - The microneedles 3100 can be hollow and can extract a fluid sample via surface tension), comprising:
collecting a bodily fluid of a user using a fluid collection component (Paragraph [0347] - The microneedles 3100 can be hollow and can extract a fluid sample via surface tension) wherein
the fluid collection component comprises one or more measurement channels configured to change color based at least in part on a concentration of one or more substances within the bodily fluid (Paragraph [0351] - As shown in FIG. 26D, the microneedle patch 3108 can communicate with the wearable device 10, using the wearable device 10 as a platform or hub to detect and/or analyze analytes in the fluid sample collected in the microneedles patch 3108. The patch 3108 can optionally include a sensor 3110, for example, an electrochemical sensor (with electrodes built into the microneedles), a colorimetric sensor, or otherwise…The device processor 14 (or optionally the sensor or module processor of the physiological parameter measurement sensor or module on the device 10) can process the signal from the sensor 3100 to determine the presence and/or concentration of certain analyte(s) in the fluid sample);
transmitting light associated with one or more wavelengths using one or more light-emitting components of a wearable ring device configured to be worn on the finger of the user that is a physically separate device from the fluid collection component, wherein at least a first light-emitting component is positioned on or within an inner cover of the wearable ring device and is configured to direct light to the first measurement channel based at least in part on the wearable ring device at least partially surrounding a portion of the finger to which the fluid collection component is attached (Paragraph [0201] - the physiological parameter measurement module 100 can include a skin-interfacing light transmissive cover 102 that encloses a plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as “detectors”) 106; Paragraph [0226] - The sensor or module 100 can include more than one group or cluster of light emitters (such as LEDs) 104 and more than one group of photodetectors (also referred to as “detectors”) 106. Each group of emitters 104 can be configured to emit four (or three) different wavelengths described herein; Paragraph [0233] - According to the Beer-Lambert law, the amount of light absorbed by a substance is proportional to the concentration of the light-absorbing substance in the irradiated solution; Paragraph [0348] - A microneedle patch may be located under one of the straps or the body of the wearable device, or be applied remotely (anywhere else on the wearer's body) from the wearable device without contacting the device; Paragraph [0349] - The patch 3108 can be applied under the skin-facing surface of the physiological parameter measurement sensor or module 100; Paragraph [0350] - Additionally or alternatively, the microneedle patch 3108 may be integrated or releasably secured to an inner side of the adjustable strap 30 of the wearable device 10, such as shown in FIG. 26C);
generating, using a photodetector of the wearable device, one or more signals based at least in part on the light reflected off the one or more measurement channels of the fluid collection component and received by the photodetector (Paragraph [0225] - The sensor or module processor 108 can be configured to drive the emitters 104 to emit light of different wavelengths and/or to process signals of attenuated light after absorption by the body tissue of the wearer from the detectors 106. The sensor or module processor 108 can determine and output for display on the device display screen 12 the physiological parameters based on the detected signals); and
determining the concentration of the one or more substances within the bodily fluid based at least in part on the one or more signals (Paragraph [0351] - The device processor 14 (or optionally the sensor or module processor of the physiological parameter measurement sensor or module on the device 10) can process the signal from the sensor 3100 to determine the presence and/or concentration of certain analyte(s) in the fluid sample).
Al-Ali et. al.’120 discloses microneedles comprising sensors capable of changing color in the presence of analytes (Paragraph [0351] - As shown in FIG. 26D, the microneedle patch 3108 can communicate with the wearable device 10, using the wearable device 10 as a platform or hub to detect and/or analyze analytes in the fluid sample collected in the microneedles patch 3108. The patch 3108 can optionally include a sensor 3110, for example, an electrochemical sensor (with electrodes built into the microneedles), a colorimetric sensor), but fails to explicitly disclose each of the microneedles comprising one or more measurement channels configured to change color based at least in part on a concentration of one or more substances within the bodily fluid. Kam et. al.’080 teaches microelectrodes comprising of sensors configured to change color within an inner channel (Column 11 Lines 26-36 - the material(s) of the microneedle 110a could be chosen to have some other specified properties. In some examples, nanosensors could be disposed on or within the microneedle 110a and exposed to an analyte in the skin 101 and an optical property of the nanosensors (e.g., a color, a fluorescence amplitude) could be detected to allow for detection of the analyte. In such examples, a material of the microneedle 110a could be chosen to have one or more optical properties (e.g., transparency, clarity, optical bandwidth, refractive index) to allow for detection of the optical property of the nanosensors; Column 12 Lines 42-48 - The nanosensors could have an optical property (e.g., a color, a degree of fluorescence, an excitation, emission, or other spectrum) that is related to the presence, concentration, or other properties of the analyte in the fluid (e.g., the optical property could change in response to binding or other selective interaction between the analyte and the nanosensor)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Al-Ali et. al.’120 to include a plurality of microelectrodes with sensors such as nanosensors within inner channels of the microelectrodes that change color when in contact with an analyte in order to detect presence of an analyte of interest while the device is obtaining fluid samples as seen in Kam et. al.’080.
Al-Ali et. al.’120 further discloses a wearable device (Paragraph [0198] - Daily use of a wearable healthcare monitoring device, which can include oximetry- or plethmosmograph-based and/or ECG physiological parameters, can be beneficial to the wearer) with adjustable straps (Paragraph [0198] - The device 10 can include an adjustable strap 30) and a releasable microneedle patch under one of the straps or remotely located (Paragraph [0348] - A microneedle patch may be located under one of the straps or the body of the wearable device, or be applied remotely (anywhere else on the wearer's body) from the wearable device without contacting the device. A plurality of microneedle patches can be applied to the wearer at different locations on the wearer's body…A surface of the patch body 3106 that is not connected to the microneedles 3100 can include an adhesive layer for releasably attach the patch 3108 to the wearable device; Paragraph [0349] - The patch 3108 can be applied under the skin-facing surface of the physiological parameter measurement sensor or module 100). Al-Ali et. al.’120 further discloses that a finger(tip) has more capillaries per volume than a wrist (Paragraph [0218] - As shown in FIG. 6, the wrist 62 has fewer capillaries per volume than the fingertip 64). Al-Ali et. al.’120 fails to disclose a ring component attached to a finger of the user. Akutagawa et. al.’339 teaches a ring-shaped sweat collection system with a detachable component configured to attach to a finger of a user (Paragraph [0078] - jewelry such as a watch, ring, bracelet, earrings or necklace, is able to include sensors or other devices to analyze the user). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Al-Ali et. al.’120 in view of Kam et. al.’080 to include a system designed in a ring-shape configured to be worn on a finger as seen in Akutagawa et. al.’339 as a mere matter of design choice and/or substitution. According to section 2144.04 MPEP IV B, configuration can be seen as a matter of choice which a person of ordinary skill in the art would have found obvious as in the case of In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Beyond being a design choice and/or substitution, a ring worn on a finger instead of a wrist has been shown to increase perfusion-index signals, increase signal fidelity, and decrease power consumption as evidenced by Boukhayma et. al.'500 (Paragraph [0004] - Low PI values lead to reduced signal fidelity; Paragraph [0008] - This idea is of particular importance to applications targeting PPG sensing on body location like the finger (ring device) or ear where the PI tends to be higher than the wrist for instance. In such cases the implementation of the modular PPG sensing scheme will come with lower power consumption).
Regarding Claim 16, the sections of Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 cited above disclose an apparatus comprising the elements set forth in the claim. Additionally, Al-Ali et. al.’120 further discloses a controller (Paragraph [0361] - A general purpose processor can be a microprocessor, but in the alternative, the processor can be a controller, microcontroller, or state machine, combinations of the same, or the like).
Regarding Claim 2, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 above as well as Al-Ali et. al.’120 further discloses transmitting a first light associated with a first wavelength (Paragraph [0254] - The emitters can be configured to emit light having a third wavelength of about 900 nm to about 910 nm, or about 905 nm, or about 907 nm. The third wavelength can be in the infrared range);
generating a first signal based at least in part on the first light reflected off the one or more measurement channels and received by the photodetector (Paragraph [0254] - The sensor or module processor can use the third wavelength as a normalizing wavelength when calculating ratios of the intensity signals of the other wavelengths, for example, a ratio of the intensity signals of the second wavelength (red) to the third wavelength (infrared));
transmitting second light associated with a second wavelength (Paragraph [0153] - The emitters can be configured to emit light having a second wavelength); and
generating a second signal based at least in part on the second light reflected off the one or more measurement channels and received by the photodetector, wherein determining the concentration is based at least in part on a comparison of the first signal and the second signal (Paragraph [0253] - The second wavelength is preferably closer to 620 nm (for example, about 625 nm), which results in greater absorption by the body tissue of the wearer, and therefore a stronger signal and/or a steeper curve in the signal, than a wavelength that is closer to 660 nm. The physiological parameter measurement sensor or module processor 108 can extract information such as the pleth waveform from signals of the second wavelength.; Paragraph [0351] - The device processor 14 (or optionally the sensor or module processor of the physiological parameter measurement sensor or module on the device 10) can process the signal from the sensor 3100 to determine the presence and/or concentration of certain analyte(s) in the fluid sample).
Regarding Claim 17, the sections of Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 cited above in Claim 2 disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 3, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 above as well as Al-Ali et. al.’120 further discloses wherein the first wavelength or the second wavelength comprise a wavelength associated with infrared light (Paragraph [0254] - The emitters can be configured to emit light having a third wavelength of about 900 nm to about 910 nm, or about 905 nm, or about 907 nm. The third wavelength can be in the infrared range).
Regarding Claim 18, the sections of Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 cited above in Claim 3 disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 5, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 above as well as Al-Ali et. al.’120 further discloses generating an electrical current using a first electrode of the wearable device (Paragraph [0247] - An electrically insulating material 127 can separate the ECG electrode 125 from the remainder of the housing 101 so that an electrical current between the ECG electrode 125 and the ECG electrodes 124 would travel through the wearer's body); and
generating a second signal based at least in part on the electrical current received through the one or more measurement channels using a second electrode of the wearable device, wherein determining the concentration of the one or more substances is based at least in part on the second signal (Paragraph [0230] - One or more ECG electrodes 125 may be located elsewhere on the device (for example, an ECG electrode 125 can form a part of the housing of the wearable device 10).
Regarding Claim 20, the sections of Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 cited above in Claim 5 disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 8, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 above as well as Al-Ali et. al.’120 further discloses causing a user device associated with the wearable device to display instructions for the user to manipulate the fluid collection component to collect the bodily fluid, to manipulate the wearable device relative to the one or more measurement channels, or both, wherein collecting the bodily fluid, transmitting the light, generating the one or more signals, or any combination thereof, is based at least in part on the instructions (Paragraph [0220] - The wearable device can output an instruction to the wearer to readjust the tightness of the straps and/or to re-center of the wearable device on the wrist. Variations (for example, if outside a certain range) in the mapped measurements can additionally or alternatively provide an indication that a certain detector or cluster of detectors is/are placed over a large pulsing vein as described above).
Regarding Claim 9, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 above as well as Al-Ali et. al.’120 further discloses wherein the one or more light-emitting components and the photodetector are configured to acquire physiological data from the user, the physiological data comprising photoplethysmogram (PPG) data, heart rate data, heart rate variability data (HRV), blood oxygen saturation data, or any combination thereof (Paragraph [0199] - The wearer can be informed of physiological parameters, such as vital signs including but not limited to heart rate (or pulse rate), and oxygen saturation by the wearable device 10; Paragraph [0218] - As described above, the physiological parameter measurement module can include a plurality of emitters and a plurality of detectors).
Regarding Claim 10, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 above as well as Al-Ali et. al.’120 further discloses wherein the fluid collection component comprises an adhesive patch, a lateral flow patch, a microfluidic chamber, a material disposed on a surface of the wearable device, or any combination thereof (Paragraph [0348] - A surface of the patch body 3106 that is not connected to the microneedles 3100 can include an adhesive layer for releasably attach the patch 3108 to the wearable device; Paragraph [0351] - As shown in FIG. 26D, the microneedle patch 3108 can communicate with the wearable device 10, using the wearable device 10 as a platform or hub to detect and/or analyze analytes in the fluid sample collected in the microneedles patch 3108).
Regarding Claim 11, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 above as well as Al-Ali et. al.’120 further discloses wherein the fluid collection component comprises an attachment component configured to couple with the wearable device (Paragraph [0348] - A surface of the patch body 3106 that is not connected to the microneedles 3100 can include an adhesive layer for releasably attach the patch 3108 to the wearable device. The adhesive layer may be covered by a back layer, which can be peeled off before applying the patch 3108 to the wearable device; Paragraph [0350] - Additionally or alternatively, the microneedle patch 3108 may be integrated or releasably secured to an inner side of the adjustable strap 30 of the wearable device 10, such as shown in FIG. 26C).
Regarding Claim 12, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 11 above as well as Al-Ali et. al.’120 further discloses wherein the attachment component is configured to position the one or more measurement channels proximate to the one or more light-emitting components, the photodetector, or both (Paragraph [0201] - the physiological parameter measurement module 100 can include a skin-interfacing light transmissive cover 102 that encloses a plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as “detectors”) 106; Paragraph [0348] - A surface of the patch body 3106 that is not connected to the microneedles 3100 can include an adhesive layer for releasably attach the patch 3108 to the wearable device. The adhesive layer may be covered by a back layer, which can be peeled off before applying the patch 3108 to the wearable device; Paragraph [0350] - Additionally or alternatively, the microneedle patch 3108 may be integrated or releasably secured to an inner side of the adjustable strap 30 of the wearable device 10, such as shown in FIG. 26C).
Regarding Claim 13, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 above as well as Al-Ali et. al.’120 further discloses wherein the bodily fluid comprises perspiration, saliva, tears, blood, or any combination thereof (Paragraph [0211] - The wearable device 10 can optionally communicate with chemical sensors, which can detect, for example, chemicals on the wearer's skin, and/or sweat; Paragraph [0347] - Alternatively or additionally, the microneedles 3100 can be used to extract a tissue fluid sample 3104 (for example, the interstitial fluid of the wearer) for detection and/or analysis of analytes in the sample 3104).
Regarding Claim 14, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 above as well as Al-Ali et. al.’120 further discloses wherein the one or more substances comprise sodium chloride, cortisol, lactate, sodium, potassium, calcium, urea, alcohol, ammonium, glucose, inflammatory markers, toxic substances, or any combination thereof (Paragraph [0347] - The analyte detection and/or analysis can provide additional information related to, for example, sodium, potassium, glucose, chloride, bicarbonate, blood urea nitrogen, magnesium, creatinine, LDL cholesterol, HDL cholesterol, triglyceride, pH, and the like).
Claims 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et. al.’120 (U.S. Patent Publication 20210290120) in view of Kam et. al.’080 (U.S. Patent 10105080), and further in view of Akutagawa et. al.’339 (U.S. Patent Publication 20200279339) as evidenced by Boukhayma et. al.'500 (U.S. Patent Publication 20220071500), as applied to Claim 1 above, and further in view of Forzani et. al.'935 (WO 2020247935 – previously cited).
Regarding Claim 4, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1, but fails to disclose the one or more measurement channels comprise a reference channel that is configured to not change color when exposed to the bodily fluid, the method further comprising: generating one or more additional signals based at least in part on the light reflected off the reference channel and received by the at least one photodetector, wherein determining the first color of the first measurement channel is based at least in part on a comparison of the one or more signals and the one or more additional signals. Forzani et. al.’935 teaches a reference area that does not change color when in contact with a biofluid (Paragraph [0006] - further includes a reference area 108/208A without a reagent modification included for providing a visual reference). Forzani et. al.’935 also teaches comparing signals from a reference area without a color-reacting reagent with signals from a sensing area that includes a color-reacting reagent in order to understand concentration of a biofluid (Paragraph [0010] – entire paragraph; Paragraph [0048] - capture light intensities in a stand-alone device for the sensing and reference areas and calculate iron concentration based on the difference of RGB values or captured light intensities, which indicate iron absorbance, between the two regions). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 to include a reference area without a color-reacting reagent and compare the signals to a sensing area with a color-reacting reagent in order to have a baseline of what the readouts are with the reference area and therefore understand the intensity of the signal received from the sensing area that applies to concentration of a biofluid as seen in Forzani et. al.’935.
Regarding Claim 19, the sections of Al-Ali et. al.’120 in view of Kam et. al.’080, further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500, and further in view of Forzani et. al.’935 cited above in Claim 4 disclose an apparatus comprising the elements set forth in the claim.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et. al.’120 (U.S. Patent Publication 20210290120) in view of Kam et. al.’080 (U.S. Patent 10105080), and further in view of Akutagawa et. al.’339 (U.S. Patent Publication 20200279339) as evidenced by Boukhayma et. al.'500 (U.S. Patent Publication 20220071500), as applied to Claim 1 above, and further in view of Begtrup et. al.'240 (WO Patent Publication 2019210240 – previously cited).
Regarding Claim 6, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 as well as Al-Ali et. al.’120 further discloses obtaining a hydration status (Paragraph [0323] - The module can further combine the hydration status monitoring by the optical detectors and other sensors (such as a sweat sensor or a skin impedance sensors) in outputting a final hydration status indication of the wearer), but fails to disclose generating an electrical current using an electrode of the wearable device, wherein the electrical current is configured to stimulate one or more sweat glands of the user, wherein collecting the bodily fluid is based at least in part on generating the electrical current. Begtrup et. al.'240 teaches creating an electric current to stimulate sweating (Paragraph [0033] - the sensor will begin to register a current when the area begins to fill with sweat; Paragraph [0039] - In other embodiments, the device may include components for stimulating sweat (not shown), such as iontophoresis electrodes). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 to include stimulating sweat in order to obtain samples as needed or necessary as seen in Begtrup et. al.'240.
Regarding Claim 7, Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 discloses the method outlined in Claim 1 as well as Al-Ali et. al.’120 further discloses displaying physiological parameter measurements to a user (Paragraph [0199] - The device 10 can display one or more of the measured physiological parameters on its display 12; Paragraph [0310] - The watch 900 can include a display screen 912 positioned at a first side of the watch housing 901. The watch housing 901 has a second side that is opposite the first side. The second side of the watch housing 901 can include an opening sized to retain the physiological parameter measurement module 600 while still allowing the tissue-facing surface of the module 600 to be exposed), but fails to explicitly disclose displaying a concentration of one or more substances. Begtrup et. al.'240 teaches providing information pertaining to sweat analyte concentrations (Paragraph [0003] - ability to provide physiological sweat rate measurements or sweat analyte concentrations that correlate to physiological concentrations). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Al-Ali et. al.’120 in view of Kam et. al.’080 and further in view of Akutagawa et. al.’339 as evidenced by Boukhayma et. al.'500 to include displaying concentrations of one or more analytes/substances in order to provide automatic reporting of measurements taken by the device as seen in Begtrup et. al.'240.
Response to Amendment
Applicant's arguments filed 02 April 2026 have been fully considered and they are not entirely persuasive.
Applicant has not made an amendment regarding the 112(f) Claim Interpretations applied in the Office Action dated 12 February 2026. Applicant has not provided any reason to withdraw the 112(f) claim interpretation, so the interpretation detailed in the Office Action is maintained. Given that the applicant did not amend the limitations addressed regarding claim interpretations, the examiner’s interpretation of the light-emitting component remains and is addressed in Paragraph 4 above.
Application’s amendments and reasons regarding overcoming the prior 35 U.S.C. 101 rejections were considered, but were found not to be persuasive. The applicant had argued "determining the concentration of the one or more substances within the bodily fluid based at least in part on the one or more signals” cannot be done by the human mind. Although the measuring step is completed via a photodetector, a photodetector is a generic device that is well-known in the art to obtain concentrations via light reflections. Additionally, the step of determining a concentration based on one or more signals can be done by the human mind as a person would be able to observe signal data and determine a concentration based on those observations as addressed in Paragraph 6 above. Furthermore, the applicant’s amendments have created an additional 101 rejection pertaining to claiming human tissue/parts as addressed in Paragraphs 5 and 7 above.
Claims 1-14 and 16-20 are newly rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 8-10 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lenigk et. al.'758 (U.S. Patent Publication 20200107758) teaches a sweat sensing device with a removable and replaceable sweat collection patch in order to dispose of the sweat collection patch after use while creating a reusable electronics module.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
Prosecution Insights