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.
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) 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 signals; and determining a presence or concentration of 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 steps of collecting bodily fluid; determining a color of a measurement channel; and determining a presence or concentration of substances within collected bodily fluid set forth a judicial exception. These steps describe 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 a presence or concentration of 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 presence or concentration of a substance 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.
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, 5-7, and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Begtrup et. al.’240 (WO Publication 2019210240 – previously cited) in view of Kim et. al.’989 (U.S. Publication Number 20200077989 – previously cited).
Regarding Claim 1, Begtrup et. al.’240 discloses a method for fluid analysis (Paragraph [0026] - The disclosed sweat sensing device may include a plurality of sensors to detect and improve detection of sweat analytes), comprising:
collecting a bodily fluid of a user using a fluid collection component (Paragraph [0029] - The substrate includes an inlet 230 that is in fluidic communication with a biofluid channel 232, and one or more sensing areas 220 (one is shown), or a volumetric sweat rate measurement channel (see, e.g., Fig. 6)), wherein
the fluid collection component comprises one or more measurement channels comprising at least a first measurement channel configured to change color when exposed to the bodily fluid (Paragraph [0033] - the sensing area 120 – shown in Figures as compartment or “channel” - contains a colorimetric sensor for glucose. As the area fills with sweat sample, the sensor will begin to change color in response to glucose in the sweat. However, the color change will not be complete until the entire area 120 is filled with sweat, at which point the sensor should be read);
transmitting light associated with one or more wavelengths using one or more light-emitting components of a wearable device (Paragraph [0034] - LED colors will be chosen to optimize readings from the particular colorimetric sensor, e.g., if a sensor produces a yellow color in the presence of an analyte, the chosen LED(s) would optimize light reflected to the photodiode to improve sensitivity or other measurement characteristic. In other embodiments, the wavelengths of transmitted and/or detected light are altered by a filter (not shown) so that transmission or detection is optimized) that is physically separate from the fluid collection component (see Annotated Figure 5 below);
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wherein the light-emitting component is configured to direct light to the first measurement channel (Paragraph [0035] - The light source 524 will emit light substantially continuously, or periodically, toward the sensing area, which is reflected and collected by the photodetector 526);
generating, using at least one photodetector of the wearable device, one or more signals based at least in part on the light reflected off the first measurement channel of the fluid collection component and received by at least one photodetector (Paragraph [0034] - Configured to have electromagnetic communication with the sensing area 520 is an output reader 522, which includes one or more light sources 524, e.g., a light- emitting diode (LED), paired with a photodetector 526…if a sensor produces a yellow color in the presence of an analyte, the chosen LED(s) would optimize light reflected to the photodiode to improve sensitivity or other measurement characteristic. In other embodiments, the wavelengths of transmitted and/or detected light are altered by a filter (not shown) so that transmission or detection is optimized);
determining a first color of the first measurement channel based at least in part on the one or more signals (Paragraph [0034] - LED colors will be chosen to optimize readings from the particular colorimetric sensor, e.g., if a sensor – present in the sensing area “channel” - produces a yellow color in the presence of an analyte, the chosen LED(s) would optimize light reflected to the photodiode to improve sensitivity or other measurement characteristic); and
determining a presence or concentration of one or more substances within the bodily fluid based at least in part on the first color (Paragraph [0033] - the sensing area 120 contains a colorimetric sensor for glucose. As the area fills with sweat sample, the sensor will begin to change color in response to glucose in the sweat).
Begtrup et. al.’240 further discloses a wearable device of different forms (Paragraph [0004] - many embodiments of the invention could benefit from mechanical or other means known to those skilled in wearable devices, patches, bandages, and other technologies or materials affixed to skin, to keep the devices or sub -components of the skin firmly affixed to skin or with pressure favoring constant contact with skin or conformal contact with even ridges or grooves in skin, and are included within the spirit of the disclosed invention), but fails to disclose the device as a wearable ring wherein at least a first light-emitting component is positioned at a first circumferential position on an inner cover of the wearable ring device. Kim et. al.'989 teaches a wearable device containing fluid collection and light-emitting components in the shape of a ring wherein at least a first light-emitting component is positioned at a first circumferential position on an inner cover of the wearable ring device (Paragraph [0065] - The wearable device may include wearable devices of a wrist watch type, a wrist band type, a ring type; Paragraph [0077] - A sweat collector 110 and an optical sensor 120 may be mounted in a lower part of the main body 1020 such that the sweat collector 110 and the optical sensor 120 are exposed to the wrist of the user. Accordingly, when the user wears the wrist-type wearable device 1000, the sweat collector 110 is naturally brought into contact with the skin of the user. In this case, the optical sensor 120 may emit light towards sweat collected by the sweat collector 110, and detect an optical signal reflected by or scattered from the sweat). 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 Begtrup et. al.’240 that involves a wearable device to include a ring design wherein the light-emitting component is positioned at a first circumferential position on an inner portion in order to be worn and removed by a user while enabling contact between the optical sensors, fluid collector, and skin of a user as seen in Kim et. al.’989.
Regarding Claim 2, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses transmitting a first light associated with a first wavelength (Paragraph [0034] – the wavelengths of transmitted and/or detected light are altered by a filter (not shown) so that transmission or detection is optimized) and 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 [0035] - The light source 524 will emit light substantially continuously, or periodically, toward the sensing area, which is reflected and collected by the photodetector 526), but fails to disclose transmitting a second light associated with a second wavelength or generating a second signal based at least in part on the second light reflected off the first measurement channel and received by the at least one photodetector, wherein determining the first color is based at least in part on a comparison of the first signal and the second signal. Kim et. al.’989 teaches transmitting more than one light at more than one wavelength (Paragraph [0048] - Each of the light sources in the light source array 121 may emit a light ray of a different wavelength to the collected sweat) and estimating a concentration of a bodily fluid by analyzing and comparing signals that have been received (Paragraph [0048] - The photodetector 122 may detect an optical signal reflected or scattered by the collected sweat. The photodetector 122 may convert the detected optical signal into an electrical signal, and transmit the electrical signal to the processor 130.; Paragraph [0055] - The processor 130 may reconstruct a sweat spectrum based on the optical signal detected by the optical sensor 120, and estimate blood concentration of analyte by analyzing the reconstructed sweat spectrum). 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 Begtrup et. al.’240 to include determining concentrations of a bodily fluid through further analysis and comparison of signals that are received by a processor at various wavelengths and time in order make more educated estimations as seen in Kim et. al.’989.
Regarding Claim 3, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 2, but fails to disclose the first wavelength or the second wavelength comprise a wavelength associated with infrared light. Kim et. al.’989 teaches a wavelength that comprises infrared (Paragraph [0048] - each of the light sources may emit a light ray of a predetermined wavelength such as, for example, a near infrared ray (NIR), to the collected sweat….the wavelength of light emitted from each of the light sources may vary according to the measurement purpose or a type of analyte). 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 Begtrup et. al.’240 I view of Kim et. al.’989 to include a wavelength comprising infrared light as it is a well-known wavelength in the art and can be used to achieve desirable measurement purposes of analytes in bodily fluids as seen in Kim et. al.’989.
Regarding Claim 5, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses generating an electrical current using a first electrode of the wearable device (Paragraph [0004] - many sensors require two or more electrodes; Paragraph [0033] - the sensor will begin to register a current when the area begins to fill with sweat); 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 presence or the concentration of the one or more substances is based at least in part on the second signal (Paragraph [0035] - there may be multiple light sources, which would allow the photodetector to collect color spectrum data, which can also be used to interpret color changes by the colorimetric sensor, and hence measure concentration).
Regarding Claim 6, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses 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 (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).
Regarding Claim 7, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses causing a user device associated with the wearable device to display a message associated with the presence or the concentration of the one or more substances (Paragraph [0005] - causing a user device associated with the wearable device to display a message associated with the presence or the concentration of the one or more substances; Paragraph [0015] - provide automatic electronic reporting of measurements taken by the device).
Regarding Claim 9, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses the one or more light-emitting components and the at least one photodetector is 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 [0004] - Sensors may be referred to by what the sensor is sensing, for example: a sweat sensor; an impedance sensor; a fluid volume sensor - could include photoplethysmogram (PPG) data - …keep the devices or sub -components of the skin firmly affixed to skin or with pressure favoring constant contact with skin or conformal contact with even ridges or grooves in skin; Paragraph [0024] - that correlate to physiological conditions in the device wearer).
Regarding Claim 10, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses 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 [0034] - the device includes a flexible substrate 550 that adheres to skin 12 via an adhesive layer 580).
Regarding Claim 11, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses the fluid collection component comprises an attachment component configured to couple with the wearable device (Paragraph [0024] – entire paragraph - body-conforming sweat sensing devices configured to measure sweat rate, or a concentration of one or more sweat analytes, that correlate to physiological conditions in the device wearer).
Regarding Claim 12, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 11. Begtrup et. al.’240 further discloses the attachment component is configured to position the one or more measurement channels proximate to the one or more light-emitting components, the at least one photodetector, or both (Paragraph [0035] - fill the sensing area 520. The light source 524 will emit light substantially continuously, or periodically, toward the sensing area, which is reflected and collected by the photodetector 526; see the proximity of elements 520, 524, and 526 outlined in the box in the Annotated Figure 5 below).
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Regarding Claim 13, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses the bodily fluid comprises perspiration, saliva, tears, blood, or any combination thereof (Paragraph [0005] - As used herein, “sweat” means a biofluid that is primarily sweat, such as eccrine or apocrine sweat, and may also include mixtures of biofluids such as sweat and blood, or sweat and interstitial fluid; Paragraph [0035] - sweat sensing device will begin to fill with sweat 14 through the inlet 530).
Regarding Claim 14, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses 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 [0028] - The sensing area 120 contains an analyte sensor (not shown), such as a colorimetric or enzymatic sensor for pH, an electrolyte, glucose, lactate or other sweat analyte).
Regarding Claims 5-14, Begtrup et. al.’240 fails to disclose the device as a wearable ring. Kim et. al.'989 teaches a wearable device in the shape of a ring (Paragraph [0065] - The wearable device may include wearable devices of a wrist watch type, a wrist band type, a ring type). Begtrup et. al.’240 already discloses using a wearable device, so identifying the element as a ring-shaped wearable device, as seen in Kim et. al.’989, would not change the function or use of fluid analysis system. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2141, A). Furthermore, 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 Begtrup et. al.’240 that involves a wearable device to include a ring design in order to be worn and removed by a user enabling contact between the optical sensors, fluid collector, and skin of a user as seen in Kim et. al.’989.
It is noted by the examiner that Begtrup et. al.’240 recited “One skilled in the art will recognize that the various embodiments may be practiced without one or more of the specific details described herein, or with other replacement and/or additional methods, materials, or components” (Paragraph [0002]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Begtrup et. al.’240 (WO Publication 2019210240 – previously cited) in view of Kim et. al.’989 (U.S. Publication Number 20200077989 – previously cited) as applied to Claim 1 above, and further in view of Forzani et. al.'935 (WO 2020247935 – previously cited).
Regarding Claim 4, Begtrup et. al.’240 in view of Kim et. al.’989 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 Begtrup et. al.’240 in view of Kim et. al.’989 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Begtrup et. al.’240 (WO Publication 2019210240 – previously cited) in view of Kim et. al.’989 (U.S. Publication Number 20200077989 – previously cited) as applied to Claim 1 above, and further in view of Mirov et. al.'925 (U.S. Publication Number 20160007925 - previously cited).
Regarding Claim 8, Begtrup et. al.’240 in view of Kim et. al.’989 discloses the method outlined in Claim 1. Begtrup et. al.’240 further discloses providing instructions to a user to manipulate activities or conditions that affect sweating (Paragraph [0014] - Sweat can also be controlled or created by asking the device wearer to conduct or increase activities or conditions that cause them to sweat), but fails to disclose 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. Mirov et. al.'925 teaches providing instructions to a user of a wearable device to adjust the placement of the wearable device in order to detect bodily fluid through the use of sensors (Paragraph [0082] - The wearable device could operate two or more sensors (e.g., photodetectors, thermistors, or some other sensors) and/or two or more light emitters and one or more photodetectors to detect alignment of the target and could indicate (e.g., by a display, an emitted sound, a vibration, or some other indicating means) the detected alignment to the wearer or to some other user such that the wearer or other user could adjust the location of the one or more components of the wearable device with the target). 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 Begtrup et. al.’240 in view of Kim et. al.’989 to include instructing a user of a wearable device to adjust the positioning of the wearable device in order to allow the sensors of the wearable device to generate signals at a target location as seen in Mirov et. al.’925.
Claims 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Begtrup et. al.’240 (WO Publication 2019210240 – previously cited) in view of Kim et. al.’989 (U.S. Publication Number 20200077989 – previously cited), and further in view of Cho et. al.’871 (WO Publication 2016117871).
Regarding Claim 16, Begtrup et. al.’240 discloses a system for fluid analysis, comprising:
a fluid collection component configured to collect a bodily fluid of a user, wherein the fluid collection component comprises one or more measurement channels comprising at least a first measurement channel configured to change color when exposed to the bodily fluid (Paragraph [0033] - the sensing area 120 contains a colorimetric sensor for glucose. As the area – sensing area 120 is shown in Figures as compartment or “channel” - fills with sweat sample, the sensor will begin to change color in response to glucose in the sweat. However, the color change will not be complete until the entire area 120 is filled with sweat, at which point the sensor should be read; Paragraph [0034] - The substrate creates one or more biofluid channels 532 that carries sweat samples to one or more sensing areas 520); and
one or more light-emitting components wherein at least a first light-emitting component is configured to direct light to the first measurement channel (Paragraph [0035] - The light source 524 will emit light substantially continuously, or periodically, toward the sensing area, which is reflected and collected by the photodetector 526); wherein
at least one photodetector (Paragraph [0034] - paired with a photodetector 526); and
one or more controllers communicatively coupled with the one or more light- emitting components and the at least one photodetector, the one or more controllers (Paragraph [0034] - an output reader 522, which includes one or more light sources 524, e.g., a light- emitting diode (LED), paired with a photodetector 526), configured to:
transmit light associated with one or more wavelengths using the one or more light-emitting components including the first light-emitting component (Paragraph [0034] - LED colors will be chosen to optimize readings from the particular colorimetric sensor, e.g., if a sensor produces a yellow color in the presence of an analyte, the chosen LED(s) would optimize light reflected to the photodiode to improve sensitivity or other measurement characteristic. In other embodiments, the wavelengths of transmitted and/or detected light are altered by a filter (not shown) so that transmission or detection is optimized);
generate, using the at least one photodetector, one or more signals based at least in part on the light reflected off the first measurement channel of the fluid collection component and received by the at least one photodetector (Paragraph [0034] - Configured to have electromagnetic communication with the sensing area 520 is an output reader 522, which includes one or more light sources 524, e.g., a light- emitting diode (LED), paired with a photodetector 526…if a sensor produces a yellow color in the presence of an analyte, the chosen LED(s) would optimize light reflected to the photodiode to improve sensitivity or other measurement characteristic. In other embodiments, the wavelengths of transmitted and/or detected light are altered by a filter (not shown) so that transmission or detection is optimized);
determine a first color of the first measurement channel based at least in part on the one or more signals (Paragraph [0035] - LED colors will be chosen to optimize readings from the particular colorimetric sensor, e.g., if a sensor produces a yellow color in the presence of an analyte, the chosen LED(s) would optimize light reflected to the photodiode to improve sensitivity or other measurement characteristic); and
determine a presence or concentration of one or more substances within the bodily fluid based at least in part on the first color (Paragraph [0033] - the sensing area 120 contains a colorimetric sensor for glucose. As the area fills with sweat sample, the sensor will begin to change color in response to glucose in the sweat).
Begtrup et. al.’240 further discloses a wearable device of different forms (Paragraph [0004] - many embodiments of the invention could benefit from mechanical or other means known to those skilled in wearable devices, patches, bandages, and other technologies or materials affixed to skin, to keep the devices or sub -components of the skin firmly affixed to skin or with pressure favoring constant contact with skin or conformal contact with even ridges or grooves in skin, and are included within the spirit of the disclosed invention), but fails to disclose the device as a wearable ring wherein at least a first light-emitting component is positioned at a first circumferential position on an inner cover of the wearable ring device. Kim et. al.'989 teaches a wearable device containing fluid collection and light-emitting components in the shape of a ring wherein at least a first light-emitting component is positioned at a first circumferential position on an inner cover of the wearable ring device (Paragraph [0065] - The wearable device may include wearable devices of a wrist watch type, a wrist band type, a ring type; Paragraph [0077] - A sweat collector 110 and an optical sensor 120 may be mounted in a lower part of the main body 1020 such that the sweat collector 110 and the optical sensor 120 are exposed to the wrist of the user. Accordingly, when the user wears the wrist-type wearable device 1000, the sweat collector 110 is naturally brought into contact with the skin of the user. In this case, the optical sensor 120 may emit light towards sweat collected by the sweat collector 110, and detect an optical signal reflected by or scattered from the sweat). 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 Begtrup et. al.’240 that involves a wearable device to include a ring design wherein the light-emitting component is positioned at a first circumferential position on an inner portion in order to be worn and removed by a user while enabling contact between the optical sensors, fluid collector, and skin of a user as seen in Kim et. al.’989.
Begtrup et. al.’240 in view of Kim et al.’989 further fails to disclose a wearable ring device that is physically separate from the fluid collection component. Cho et. al.’871 teaches a wearable device that is configured to be physically separate from a fluid collection component (Paragraph [70] - The wearable part 307 may be worn on the body, and the induction body part 311 may be detachably attached to the driving circuit part 308. That is, the induction part 301 and the collection part 303 formed in the induction body part 311 may be detachably attached to the wearable part 307. The wearable part 307 may have an attachment/detachment groove 371 to/from which the induction body part 311 and the driving circuit part 308 are simultaneously inserted and attached/detached). 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 system of Begtrup et. al.’240 in view of Kim et. al.’989 to include an attachment/detachment groove for a fluid collector to fit into a wearable device in order to replace fluid collector elements for new fluid collector elements or between users as seen in Cho et. al.’871 (Paragraph [71] - In this way, in the wearable body composition analyzer 300 according to yet another one of various embodiments of the present disclosure, the induction part 301, the collection part 303, and the sensor part 305 used by a user are detached from the wearable part 307, are replaced with another induction part, another collection part, another sensor part, and thus, are mounted to the wearable part 307).
Regarding Claim 17, Begtrup et. al.’240 in view of Kim et. al.’989 and further in view of Cho et. al.’871 discloses the system outlined in Claim 16. Begtrup et. al.’240 further discloses transmitting a first light associated with a first wavelength (Paragraph [0034] – the wavelengths of transmitted and/or detected light are altered by a filter (not shown) so that transmission or detection is optimized) and 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 [0035] - The light source 524 will emit light substantially continuously, or periodically, toward the sensing area, which is reflected and collected by the photodetector 526), but fails to disclose transmitting a second light associated with a second wavelength or generating a second signal based at least in part on the second light reflected off the first measurement channel and received by the at least one photodetector, wherein determining the first color is based at least in part on a comparison of the first signal and the second signal. Kim et. al.’989 teaches transmitting more than one light at more than one wavelength (Paragraph [0048] - Each of the light sources in the light source array 121 may emit a light ray of a different wavelength to the collected sweat) and estimating a concentration of a bodily fluid by analyzing and comparing signals that have been received (Paragraph [0048] - The photodetector 122 may detect an optical signal reflected or scattered by the collected sweat. The photodetector 122 may convert the detected optical signal into an electrical signal, and transmit the electrical signal to the processor 130.; Paragraph [0055] - The processor 130 may reconstruct a sweat spectrum based on the optical signal detected by the optical sensor 120, and estimate blood concentration of analyte by analyzing the reconstructed sweat spectrum). 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 system of Begtrup et. al.’240 to include determining concentrations of a bodily fluid through further analysis and comparison of signals that are received by a processor at various wavelengths and time in order make more educated estimations as seen in Kim et. al.’989.
Regarding Claim 18, Begtrup et. al.’240 in view of Kim et. al.’989 and further in view of Cho et. al.’871 discloses the system outlined in Claim 16, but fails to disclose the first wavelength or the second wavelength comprise a wavelength associated with infrared light. Kim et. al.’989 teaches a wavelength that comprises infrared (Paragraph [0048] - each of the light sources may emit a light ray of a predetermined wavelength such as, for example, a near infrared ray (NIR), to the collected sweat….the wavelength of light emitted from each of the light sources may vary according to the measurement purpose or a type of analyte). 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 Begtrup et. al.’240 I view of Kim et. al.’989 to include a wavelength comprising infrared light as it is a well-known wavelength in the art and can be used to achieve desirable measurement purposes of analytes in bodily fluids as seen in Kim et. al.’989.
Regarding Claim 20, Begtrup et. al.’240 in view of Kim et. al.’989, and further in view of Cho et. al.’871 discloses the system outlined in Claim 16 above. Begtrup et. al.’240 further discloses the one or more controllers are further configured to:
generate an electrical current using a first electrode of the wearable device (Paragraph [0004] - many sensors require two or more electrodes, reference electrodes, or additional supporting technology or features that are not captured in the description herein. Sensors are preferably electrical in nature; Paragraph [0033] - the sensor will begin to register a current when the area begins to fill with sweat); and
generate 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 presence or the concentration of the one or more substances is based at least in part on the second signal (Paragraph [0035] - there may be multiple light sources, which would allow the photodetector to collect color spectrum data, which can also be used to interpret color changes by the colorimetric sensor, and hence measure concentration).
It is noted by the examiner that Begtrup et. al.’240 fails to disclose the device as a wearable ring. Kim et. al.'989 teaches a wearable device in the shape of a ring (Paragraph [0065] - The wearable device may include wearable devices of a wrist watch type, a wrist band type, a ring type). Begtrup et. al.’240 already discloses using a wearable device, so identifying the element as a ring-shaped wearable device, as seen in Kim et. al.’989, would not change the function or use of fluid analysis system. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2141, A). Furthermore, 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 Begtrup et. al.’240 that involves a wearable device to include a ring design in order to be worn and removed by a user enabling contact between the optical sensors, fluid collector, and skin of a user as seen in Kim et. al.’989.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Begtrup et. al.’240 (WO Publication 2019210240 – previously cited) in view of Kim et. al.’989 (U.S. Publication Number 20200077989 – previously cited), and further in view of Cho et. al.’871 as applied to Claim 16 above, and further in view of Forzani et. al.'935 (WO 2020247935 – previously cited).
Regarding Claim 19, Begtrup et. al.’240 in view of Kim et. al.’989 and further in view of Cho et. al.’871 discloses the system outlined in Claim 19, 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 Begtrup et. al.’240 in view of Kim et. al.’989 and further in view of Cho et. al.’871 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.
Response to Amendment
Applicant's arguments filed 11 November 2025 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior claim objections.
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 3 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 identified "transmitting light using light-emitting components" and "generating one or more signals" as part of the Abstract Idea, but as addressed in the Paragraphs above, the examiner notes that these steps are insignificant pre-solution activity, such as data gathering, used to perform the Abstract Idea. Regarding the sensors being positioned on the inside of a ring, the examiner has cited prior art that teaches a similar structure and therefore has proven that this specific setup is not unique or specialized to the instant application's invention. The analysis of the 101 rejection is in Paragraph 5 above.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 5-9 above. It is noted that Claims 1, 5-7, 9-14, 16, and 20 that were once rejected under 35 U.S.C. 102 are now rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraph 5 above.
Additionally, the amendments to Claim 16 recite limitations that make it clear that the wearable device is separate from the fluid collection component, as addressed in Paragraph 8 above. However, the amended limitations recited in Claim 1 have been interpreted such that the light-emitting components are separate from the fluid collection component, as addressed in Paragraph 5 above.
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.
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.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791