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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 and 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the limitation “wherein each of the peaks corresponds to an increase in the ratio at a respective one of the different times” recited in lines 13-14 of the claim renders the claim indefinite. It is unclear how an increase can be seen “at a respective one of the different times” as an increase should be observed between at least two different times. For this examination, the phrase is being interpreted as “wherein each of the peaks corresponds to an increase in the ratio across different points in time”.
Regarding Claim 20, the limitation “based on each of the vector lengths” lacks proper antecedent basis. This limitation is being interpreted to mean “based on vector lengths corresponding”.
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
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 1-9 and 17-26 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 components, including a toothbrush comprising a sensor configured to emit a first light at a first wavelength and a second light at a second wavelength; receive reflected portions of the first light and the second light; and generate a first signal indicative of a first intensity and a second signal indicative of a second intensity; a processor configured to calculate a ratio of the first intensity to the second intensity; a processor configured to identify peaks in the ratio over the different times; a processor configured to determine whether hemoglobin is present in the oral cavity based on a number of peaks in the ratio over the different times; and a processor configured to provide an indication to a user that blood is present in the oral cavity. Thus, the claim is directed to a machine, 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 functions of calculating a ratio of the first intensity to the second intensity is drawn to a Mathematical Concept (using a mathematical formula), which is an Abstract Idea. Identifying peaks in the ratio over the different times and determining whether hemoglobin is present in the oral cavity can be 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 whether hemoglobin is present in the oral cavity based on a number of peaks in the ratio over the different times or indicating to a user that blood is present in the oral cavity that imposes a meaningful limitation on the Abstract Idea. The determining and indicating functions as recited do not provide an improvement to the technological field, the functions do not effect a particular treatment or effect a particular change based on the determinations, nor is a particular machine used to perform the Abstract Idea. The Abstract Idea is performed by a computer – the processor. 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. Additionally, indicating to a user that blood is present in the oral cavity is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)).
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 a toothbrush comprising a generic sensor configured to perform additional functions of emitting a first light at a first wavelength and a second light at a second wavelength, receiving reflected portion of the first light and the second light, and generating a first signal indicative of a first intensity of the reflected portion of the first light and a second signal indicative of a second intensity of the reflected portion of the second light. The emitting, receiving, and generating functions are recited at a high level of generality such that they amount to insignificant pre-solution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea, and the elements configured to perform these functions are recited at a high level of generality. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional function that distinguishes it from well-understood, routine, and conventional data gathering or response 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 emitting, receiving, and generating functions 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.
The same rationale for Claim 1 applies to Claim 17. Claim 17 recites the additional functions of identifying which of the data points are inside and outside predetermined boundaries as well as determining whether hemoglobin is present in the oral cavity based on a characteristic of the data points inside and outside predetermined boundaries. However, these claims are analogous to those in Claim 1 and are also drawn to functions that can be 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. Similarly to Claim 1, the determining whether hemoglobin is present in the oral cavity based on a characteristic of the data points inside or outside the predetermined boundaries and providing an indication to a user that blood is present in the oral cavity recited in Claim 17 does not provide an improvement to the technological field, the functions do not effect a particular treatment or effect a particular change based on the determinations, nor is a particular machine used to perform the Abstract Idea. The Abstract Idea is performed by a computer – the processor. 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. Additionally, indicating to a user that blood is present in the oral cavity is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)).
Dependent Claims 2-9 and 18-26 fail to add something more to the abstract independent claim as they generally recite structural components with some pertaining to data gathering functions, but the functions recited in each claim are stated at such a high generality that they amount to nothing more than pre-solution data gathering and post-solution data activity that do not use a particular machine to perform the Abstract Idea. It is noted that Claim 25 uses “a tracking sensor”, but this is a generic device configured to act as an additional element for pre-solution data gathering.
The emitting, receiving, generating, calculating, identifying, determining, and providing functions recited in the independent claims, Claims 1 and 17, 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, 6-8, 17-18, 22, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen et. al.'459 (U.S. Patent Publication 20210315459 – previously cited) in view of Yamamoto et. al.'703 (U.S. Patent Publication 20130053703) as evidenced by Miller’893 (U.S. Patent Publication 20100231893).
Regarding Claim 1, Vermeulen et. al.'459 discloses a system for detecting blood in an oral cavity during toothbrushing (Paragraph [0012] - the invention provides a system that (i) is configured to provide an indication of a person's gum health on the basis of an evaluation of the presence of blood traces in a sample containing the person's saliva), the system comprising:
a toothbrush comprising a sensor (Paragraph [0040] - it is noted that when the invention involves use of an oral care appliance such as a power toothbrush) configured to:
emit a first light at a first wavelength and a second light at a second wavelength (Paragraph [0036] - measurements values relating to only a limited number of main wavelengths and a limited number of auxiliary wavelengths, probably no more than one or two main wavelengths and no more than one or two auxiliary wavelengths, is considered to be sufficient for discriminating blood (actually, the hemoglobin of the blood or possibly another constituent of the blood) against a background and thereby determining whether or not a sample contains blood);
receive reflected portions of the first light and the second light (Paragraph [0061] - The measurement of light absorption/transmission values and the processing of those values related to two or more predetermined wavelengths of the light can take place by means of a tool having a basic setup as illustrated in FIG. 2, for example, wherein the light detector 25 is placed at the same side of the glass slide 24 with the sample 23 as the light source 21 and the collimator 22 so as to allow for performing measurements of light in reflection); and
for each of a plurality of different times, generate a first signal indicative of a first intensity of the reflected portion of the first light and a second signal indicative of a second intensity of the reflected portion of the second light (Paragraph [0017] - A first step involves determination of measurement values of light received by the light-receiving unit for one or more main wavelengths of the light, and also for one or more auxiliary wavelengths of the light; Paragraph [0026] - Collecting the sample can be done in various ways, ranging from having an area on an oral care appliance that is particularly shaped for this purpose to having a person spit out some saliva. Further, commonly available light sources such as LEDs may be used as light-emitting units, possibly in combination with optical filters, and commonly available light detectors such as photodiodes may be used as light-receiving units, wherein there is no need for an expensive spectrometer; Paragraph [0040] - The results of successive analysis actions may be saved and may be subjected to further analysis so as to perform an assessment of trends over time; Paragraph [0063] - In a spectral detection process, two wavelengths are covered: one main wavelength for measuring the absorption of hemoglobin, preferably chosen from a range of 410-430 nm, and one auxiliary wavelength chosen from a range where the absorption of hemoglobin is known to be considerably less, such as a wavelength in a range of 440-470 nm or a wavelength higher than 650 nm); and
a processor operably coupled to the sensor (Paragraph [0026] - The analysis unit may be provided in the form of a preprogrammed microprocessor or a general microprocessor in combination with a suitable app or the like for controlling operation of the microprocessor, to mention two practical examples; Paragraph [0041] - For example, an assembly of the system according to the invention and a mobile device comprising a light, an image chip and a processor is feasible, wherein the analysis unit of the system comprises the processor of the mobile device, and wherein the at least one algorithm to be executed by the analysis unit is defined by an app installed on the mobile device. The mobile device may also comprise a light and an image chip, in which case it may be advantageous if the light-emitting unit of the system comprises the light of the mobile device and the light-receiving unit of the system comprises the image chip of the mobile device) and configured to:
for each of the plurality of different times, receive the first signal and the second signal, and calculate a ratio of the first intensity to the second intensity (Paragraph [0026] - Collecting the sample can be done in various ways, ranging from having an area on an oral care appliance that is particularly shaped for this purpose to having a person spit out some saliva. Further, commonly available light sources such as LEDs may be used as light-emitting units, possibly in combination with optical filters, and commonly available light detectors such as photodiodes may be used as light-receiving units, wherein there is no need for an expensive spectrometer; Paragraph [0027] - Examples of suitable ways of determining a discrimination value are the following; Paragraph [0029] - dividing a measurement value relating to a main wavelength by a measurement value relating to an auxiliary wavelength); and
a processor configured to identify peaks in the ratio over the different times (Paragraph [0022] - It is known that the hemoglobin of blood has a light absorption spectrum in which absorption peaks can clearly be distinguished at wavelength values in a range of about 400-440nm; Paragraph [0032] - In respect of the first example of the way in which a discrimination value may be determined, it is noted that the respective measurement values may be transmission values, and that in the possible further step of the analysis, the discrimination value may be compared to a predetermined transmission value difference that is chosen so as to distinguish between a presence of blood and an absence of blood; Paragraph [0053] - the invention provides a reliable method for detecting low hemoglobin concentrations, by using optical detection based on the known absorption peaks in the hemoglobin absorption spectrum; Paragraph [0066] - the auxiliary wavelength can be taken from the red or the green channel from the image chip of the smartphone, wherein it is noted that taking the auxiliary wavelength from the red channel is preferred; Paragraph [0072] - Thus, by monitoring time dependence of the signal that is obtained from the oral care device, it is possible to keep track of moments at which a release of blood is invoked); and
an indicator operably coupled to the processor and configured to, in response to the processor determining that hemoglobin is present, provide an indication to a user that blood is present in the oral cavity (Paragraph [0063] - The diffuse reflective probe 40 further includes a light detector 25 coupled to an analysis unit 26 configured to determine whether or not blood is present in the sample 23 and to provide an indication that it is likely that a person suffers from reduced or poor gum health, or not…The probe 40 may be equipped with a suitable indicator for issuing a warning signal in case blood appears to be detected).
Vermeulen et. al.'459 fails to disclose wherein each of the peaks corresponds to an increase in the ratio across different points in time. Yamamoto et. al.'703 teaches an increase in a reflected red to green ratio is indicative of an increase in amount of blood in an observation area (Paragraph [0158] - The image signal ratio R2/G2 has a positive correlation with the amount of blood C because of the characteristic of the hemoglobin's light absorption coefficient. It is apparent from the graph that as the image signal ratio R2/G2 increases, the amount of blood C contained in the subject's observation region increases). 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 Vermeulen et. al.’459 to include comparing the ratio of light reflected at two different wavelengths such as red and green wavelengths in order to understand the amount of blood in an area being observed as seen in Yamamoto et. al.'703. Presence of blood can be detected using intensities of reflectance of different wavelengths in response to hemoglobin as evidenced by Miller’893 (Paragraph [0013] - There are many instances in which it is desirable to detect blood. Blood, both dry and wet, contains a significant amount of hemoglobin. Hemoglobin absorbs and reflects light at varying amounts based on the wavelength of light. For example, hemoglobin reflects more light around 700 nanometers (nm) and absorbs more light around 400 nm; Paragraph [0027] - Hemoglobin in blood strongly absorbs light at 425 nm and strongly reflects light at 700 nm. Other substances in the region may not strongly reflect or strongly absorb light at either 700 nm or 425 nm. If a region without blood is examined, light from both wavelengths may be expected to reflect off the region at approximately the same intensity. However, if blood is present in the region, the intensity of the light reflected at 700 nm may be greater than the intensity of light reflected at 425 nm).
Vermeulen et. al.'459 further fails to disclose determining whether hemoglobin is present in the oral cavity based on a number of peaks in the ratio over the different times. Yamamoto et. al.'703 teaches identifying a presence of hemoglobin based on the intensity of reflected light between red and green light in an observation area (Paragraph [0123] - The green and the red image signal (image data) from a normal sensor yield information on light absorption by blood corresponding to the wavelengths of green and red light; Paragraph [0158] - The image signal ratio R2/G2 has a positive correlation with the amount of blood C because of the characteristic of the hemoglobin's light absorption coefficient. It is apparent from the graph that as the image signal ratio R2/G2 increases, the amount of blood C contained in the subject's observation region increases). 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 Vermeulen et. al.’459 to include identifying a presence of hemoglobin based on peaks related to a ratio of wavelengths wherein one has low blood absorbance and the other has high blood absorbance in order to account for an amount of blood present in an area of observation as seen in Yamamoto et. al.’703. Hemoglobin-related intensities increase – peak – as light is reflected at a wavelength above about 425nm as evidenced by Miller’893 (Paragraph [0027] - Hemoglobin in blood strongly absorbs light at 425 nm and strongly reflects light at 700 nm. Other substances in the region may not strongly reflect or strongly absorb light at either 700 nm or 425 nm. If a region without blood is examined, light from both wavelengths may be expected to reflect off the region at approximately the same intensity. However, if blood is present in the region, the intensity of the light reflected at 700 nm may be greater than the intensity of light reflected at 425 nm; Paragraph [0032] - The analyzer 330 compares the intensities of light at specific wavelengths received by the receiver 320 to determine if blood 305 is present in the region 301).
Regarding Claim 3, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 1 above. Vermeulen et. al.'459 further discloses determining whether hemoglobin is present during a brushing session (Paragraph [0055] - The invention provides a way of discriminating blood against a background of saliva or a mix of saliva and toothpaste in order to check a sample containing saliva, obtained during or after an oral care action such as brushing or flossing for traces of blood), but fails to disclose wherein the determination whether hemoglobin is present is based on the number of peaks during a brushing session that meets or exceeds a predetermined non-zero number. Yamamoto et. al.'703 teaches identifying a presence of hemoglobin based on a presence of red light-related intensity peaks in an observation area (Paragraph [0158] - The image signal ratio R2/G2 has a positive correlation with the amount of blood C because of the characteristic of the hemoglobin's light absorption coefficient. It is apparent from the graph that as the image signal ratio R2/G2 increases, the amount of blood C contained in the subject's observation region increases). 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 Vermeulen et. al.’459 to include identifying a presence of hemoglobin-related peaks within a spectral graph in order to account for an amount of blood present in an area of observation as seen in Yamamoto et. al.’703. Hemoglobin-related intensities increase – peak – as light is reflected at a wavelength above about 425nm as evidenced by Miller’893 (Paragraph [0027] - Hemoglobin in blood strongly absorbs light at 425 nm and strongly reflects light at 700 nm. Other substances in the region may not strongly reflect or strongly absorb light at either 700 nm or 425 nm. If a region without blood is examined, light from both wavelengths may be expected to reflect off the region at approximately the same intensity. However, if blood is present in the region, the intensity of the light reflected at 700 nm may be greater than the intensity of light reflected at 425 nm; Paragraph [0032] - The analyzer 330 compares the intensities of light at specific wavelengths received by the receiver 320 to determine if blood 305 is present in the region 301).
Regarding Claim 6, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 1 above, but fails to disclose the processor is configured to calculate an amount of blood detected in the oral cavity during a toothbrushing session based on the number of peaks. Yamamoto et. al.'703 teaches identifying an amount of hemoglobin based on a number of red to green light-related intensity peaks in an observation area (Paragraph [0158] - The image signal ratio R2/G2 has a positive correlation with the amount of blood C because of the characteristic of the hemoglobin's light absorption coefficient. It is apparent from the graph that as the image signal ratio R2/G2 increases, the amount of blood C contained in the subject's observation region increases). 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 Vermeulen et. al.’459 to include identifying an amount of hemoglobin based on an existence of peaks related to a ratio of wavelengths wherein one has low blood absorbance and the other has high blood absorbance in order to account for an amount of blood present in an area of observation as seen in Yamamoto et. al.’703. Hemoglobin-related intensities increase – peak – as light is reflected at a wavelength above about 425nm as evidenced by Miller’893 (Paragraph [0027] - Hemoglobin in blood strongly absorbs light at 425 nm and strongly reflects light at 700 nm. Other substances in the region may not strongly reflect or strongly absorb light at either 700 nm or 425 nm. If a region without blood is examined, light from both wavelengths may be expected to reflect off the region at approximately the same intensity. However, if blood is present in the region, the intensity of the light reflected at 700 nm may be greater than the intensity of light reflected at 425 nm; Paragraph [0032] - The analyzer 330 compares the intensities of light at specific wavelengths received by the receiver 320 to determine if blood 305 is present in the region 301).
Regarding Claim 7, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 1 above. Vermeulen et. al.’459 further discloses wherein the toothbrush further comprises a tracking sensor configured to generate location signals related to a location of a head of the toothbrush within the oral cavity during toothbrushing, and wherein the processor is operably coupled to the tracking sensor and configured to receive the location signals to determine a location of the head of the toothbrush within the oral cavity when each peak is detected (Paragraph [0072] - In the case of an oral care device, it is possible to keep track of a position of (a part of) the oral care device with respect to the mouth. For example, if a toothbrush is used, information about the actual position of the brush head 61 may continually be available on the basis of suitable control and/or detection measures. In the context of the invention, such information may be used for obtaining gum health indications at a local level, so that areas of reduced/poor gum health in the mouth may be distinguished from areas of acceptable/good gum health).
Regarding Claim 8, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 1 above. Vermeulen et. al.'459 further discloses the sensor is further configured to emit a third light at a third wavelength, receive reflected portions of the third light, and generate a third signal indicative of a third intensity of the reflected portion of the third light (Paragraph [0059] - At the higher wavelength values, the transmission values are mainly influenced by the presence of toothpaste while the blood absorption is very low, whereas at the lower wavelength values, especially the values in the range of 410-430 nm, the contribution of the blood is far more significant. In case a particular type of toothpaste has a color on the basis of which the toothpaste is highly absorbing in the same range of wavelengths as blood, a third measurement value obtained at a third wavelength can be used for further correction); and wherein the processor is further configured to:
at the plurality of different times, receive the third signal, and calculate a second ratio of the third intensity to the second intensity (Paragraph [0018] - A second step involves determination of a discrimination value on the basis of the measurement values, wherein in the process of determining the discrimination value, a measurement value relating to a main wavelength is adjusted with (a) measurement value(s) relating to one or more auxiliary wavelengths. In case measurement values relating to two or more main wavelengths are used for the purpose of determining a discrimination value, each of those measurement values may be adjusted with (a) measurement value(s) relating to one or more auxiliary wavelengths. In such a case, the analysis unit may be configured to calculate a discrimination value that is a combination of the adjusted measurement values of the main wavelengths, such as a weighed sum of the adjusted measurement values of the main wavelengths); and
identify peaks in the second ratio over the different times (Paragraph [0026] - The analysis unit may be provided in the form of a preprogrammed microprocessor or a general microprocessor in combination with a suitable app or the like for controlling operation of the microprocessor, to mention two practical examples).
Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 fails to disclose the determination whether hemoglobin is present is based further on the number of peaks in the second ratio over the different times. Yamamoto et. al.'703 teaches identifying a presence of hemoglobin based on a presence of red light-related intensity peaks in an observation area (Paragraph [0158] - The image signal ratio R2/G2 has a positive correlation with the amount of blood C because of the characteristic of the hemoglobin's light absorption coefficient. It is apparent from the graph that as the image signal ratio R2/G2 increases, the amount of blood C contained in the subject's observation region increases). 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 Vermeulen et. al.’459 to include identifying a presence of hemoglobin-related peaks within a spectral graph in order to account for an amount of blood present in an area of observation as seen in Yamamoto et. al.’703. Hemoglobin-related intensities increase – peak – as light is reflected at a wavelength above about 425nm as evidenced by Miller’893 (Paragraph [0027] - Hemoglobin in blood strongly absorbs light at 425 nm and strongly reflects light at 700 nm. Other substances in the region may not strongly reflect or strongly absorb light at either 700 nm or 425 nm. If a region without blood is examined, light from both wavelengths may be expected to reflect off the region at approximately the same intensity. However, if blood is present in the region, the intensity of the light reflected at 700 nm may be greater than the intensity of light reflected at 425 nm; Paragraph [0032] - The analyzer 330 compares the intensities of light at specific wavelengths received by the receiver 320 to determine if blood 305 is present in the region 301).
Regarding Claim 17, Vermeulen et. al.'459 discloses a system for detecting blood in an oral cavity during toothbrushing (Paragraph [0012] - the invention provides a system that (i) is configured to provide an indication of a person's gum health on the basis of an evaluation of the presence of blood traces in a sample containing the person's saliva), the system comprising:
a toothbrush comprising a sensor (Paragraph [0040] - it is noted that when the invention involves use of an oral care appliance such as a power toothbrush) configured to:
emit a first light at a first wavelength and a second light at a second wavelength (Paragraph [0036] - measurements values relating to only a limited number of main wavelengths and a limited number of auxiliary wavelengths, probably no more than one or two main wavelengths and no more than one or two auxiliary wavelengths, is considered to be sufficient for discriminating blood (actually, the hemoglobin of the blood or possibly another constituent of the blood) against a background and thereby determining whether or not a sample contains blood) into the oral cavity toward a toothpaste slurry during a toothbrushing session (Paragraph [0055] - The invention provides a way of discriminating blood against a background of saliva or a mix of saliva and toothpaste in order to check a sample containing saliva, obtained during or after an oral care action such as brushing or flossing for traces of blood);
receive reflected portions of the first light and the second light from the toothpaste slurry (Paragraph [0055] - The invention provides a way of discriminating blood against a background of saliva or a mix of saliva and toothpaste in order to check a sample containing saliva, obtained during or after an oral care action such as brushing or flossing for traces of blood; Paragraph [0061] - The measurement of light absorption/transmission values and the processing of those values related to two or more predetermined wavelengths of the light can take place by means of a tool having a basic setup as illustrated in FIG. 2, for example, wherein the light detector 25 is placed at the same side of the glass slide 24 with the sample 23 as the light source 21 and the collimator 22 so as to allow for performing measurements of light in reflection); and
for each of a plurality of different times, generate a first signal indicative of a first intensity of the reflected portion of the first light and a second signal indicative of a second intensity of the reflected portion of the second light (Paragraph [0017] - A first step involves determination of measurement values of light received by the light-receiving unit for one or more main wavelengths of the light, and also for one or more auxiliary wavelengths of the light; Paragraph [0026] - Collecting the sample can be done in various ways, ranging from having an area on an oral care appliance that is particularly shaped for this purpose to having a person spit out some saliva. Further, commonly available light sources such as LEDs may be used as light-emitting units, possibly in combination with optical filters, and commonly available light detectors such as photodiodes may be used as light-receiving units, wherein there is no need for an expensive spectrometer; Paragraph [0040] - The results of successive analysis actions may be saved and may be subjected to further analysis so as to perform an assessment of trends over time; Paragraph [0063] - In a spectral detection process, two wavelengths are covered: one main wavelength for measuring the absorption of hemoglobin, preferably chosen from a range of 410-430 nm, and one auxiliary wavelength chosen from a range where the absorption of hemoglobin is known to be considerably less, such as a wavelength in a range of 440-470 nm or a wavelength higher than 650 nm); and
a processor operably coupled to the sensor (Paragraph [0026] - The analysis unit may be provided in the form of a preprogrammed microprocessor or a general microprocessor in combination with a suitable app or the like for controlling operation of the microprocessor, to mention two practical examples; Paragraph [0041] - For example, an assembly of the system according to the invention and a mobile device comprising a light, an image chip and a processor is feasible, wherein the analysis unit of the system comprises the processor of the mobile device, and wherein the at least one algorithm to be executed by the analysis unit is defined by an app installed on the mobile device. The mobile device may also comprise a light and an image chip, in which case it may be advantageous if the light-emitting unit of the system comprises the light of the mobile device and the light-receiving unit of the system comprises the image chip of the mobile device) and configured to:
for each of the plurality of different times during the toothbrushing session (Paragraph [0055] - The invention provides a way of discriminating blood against a background of saliva or a mix of saliva and toothpaste in order to check a sample containing saliva, obtained during or after an oral care action such as brushing or flossing for traces of blood):
receive the first signal and the second signal, and calculate a ratio of the first intensity to the second intensity (Paragraph [0026] - Collecting the sample can be done in various ways, ranging from having an area on an oral care appliance that is particularly shaped for this purpose to having a person spit out some saliva. Further, commonly available light sources such as LEDs may be used as light-emitting units, possibly in combination with optical filters, and commonly available light detectors such as photodiodes may be used as light-receiving units, wherein there is no need for an expensive spectrometer; Paragraph [0027] - Examples of suitable ways of determining a discrimination value are the following; Paragraph [0029] - dividing a measurement value relating to a main wavelength by a measurement value relating to an auxiliary wavelength);
wherein the ratios for different times form data points, each of the data points corresponding to the ratio at a respective one of the different times; identify which of the data points are inside predetermined boundaries and which of the data points are outside the predetermined boundaries; and determine whether hemoglobin is present in the oral cavity based on a characteristic of the data points inside the predetermined boundaries or the data points outside the predetermined boundaries (Paragraph [0040] - In a practical embodiment, the system according to the invention may be equipped with an indicator configured to emit a signal in case the discrimination value is found to be in the range of values indicative of the presence of blood in a sample, i.e. above or below a reference value, whatever the case may be); and
an indicator operably coupled to the processor and configured to, in response to the processor determining that hemoglobin is present, provide an indication to a user that blood is present in the oral cavity (Paragraph [0063] - The diffuse reflective probe 40 further includes a light detector 25 coupled to an analysis unit 26 configured to determine whether or not blood is present in the sample 23 and to provide an indication that it is likely that a person suffers from reduced or poor gum health, or not…The probe 40 may be equipped with a suitable indicator for issuing a warning signal in case blood appears to be detected).
Vermeulen et. al.'459 fails to disclose determining whether hemoglobin is present in the oral cavity based on a number of peaks in the ratio over the different times. Yamamoto et. al.'703 teaches identifying a presence of hemoglobin based on a presence of red light-related intensity peaks in an observation area (Paragraph [0158] - The image signal ratio R2/G2 has a positive correlation with the amount of blood C because of the characteristic of the hemoglobin's light absorption coefficient. It is apparent from the graph that as the image signal ratio R2/G2 increases, the amount of blood C contained in the subject's observation region increases). 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 Vermeulen et. al.’459 to include identifying a presence of hemoglobin-related peaks within a spectral graph in order to account for an amount of blood present in an area of observation as seen in Yamamoto et. al.’703. Hemoglobin-related intensities increase – peak – as light is reflected at a wavelength above about 425nm as evidenced by Miller’893 (Paragraph [0027] - Hemoglobin in blood strongly absorbs light at 425 nm and strongly reflects light at 700 nm. Other substances in the region may not strongly reflect or strongly absorb light at either 700 nm or 425 nm. If a region without blood is examined, light from both wavelengths may be expected to reflect off the region at approximately the same intensity. However, if blood is present in the region, the intensity of the light reflected at 700 nm may be greater than the intensity of light reflected at 425 nm; Paragraph [0032] - The analyzer 330 compares the intensities of light at specific wavelengths received by the receiver 320 to determine if blood 305 is present in the region 301).
Regarding Claim 18, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 17 above. Vermeulen et. al.’459 further discloses wherein the predetermined boundaries are formed by a minimum value and a maximum value (Paragraph [0040] - In a practical embodiment, the system according to the invention may be equipped with an indicator configured to emit a signal in case the discrimination value is found to be in the range of values indicative of the presence of blood in a sample, i.e. above or below a reference value, whatever the case may be).
Regarding Claim 22, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 17 above. Vermeulen et. al.’459 further discloses wherein the characteristic upon which the determination whether hemoglobin is present is a spread of the data points inside the predetermined boundaries (Paragraph [0040] - In a practical embodiment, the system according to the invention may be equipped with an indicator configured to emit a signal in case the discrimination value is found to be in the range of values indicative of the presence of blood in a sample, i.e. above or below a reference value, whatever the case may be).
Regarding Claim 24, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 17 above. Vermeulen et. al.’459 further discloses wherein the processor is configured to calculate an amount of blood detected in the oral cavity during a toothbrushing session based on the characteristic of the data points inside or outside the predetermined boundaries (Paragraph [0040] - In a practical embodiment, the system according to the invention may be equipped with an indicator configured to emit a signal in case the discrimination value is found to be in the range of values indicative of the presence of blood in a sample, i.e. above or below a reference value, whatever the case may be; Paragraph [0060] - All in all, it follows from the tests that even a simple setup is sufficient for enabling detection of small amount of blood in a solution containing toothpaste. The invention provides a way of detecting much lower blood concentrations in a toothpaste-saliva mix than can be done by the human eye, and therefore enables detection of gingivitis or other conditions affecting gum health in an early, reversible stage).
Regarding Claim 25, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 17 above. Vermeulen et. al.'459 further discloses wherein the toothbrush further comprises a tracking sensor configured to generate location signals related to a location of a head of the toothbrush within the oral cavity during toothbrushing, and wherein the processor is operably coupled to the tracking sensor and configured to receive the location signals to determine a location of the head when the determination that hemoglobin is present occurs (Paragraph [0072] - In the case of an oral care device, it is possible to keep track of a position of (a part of) the oral care device with respect to the mouth. For example, if a toothbrush is used, information about the actual position of the brush head 61 may continually be available on the basis of suitable control and/or detection measures. In the context of the invention, such information may be used for obtaining gum health indications at a local level, so that areas of reduced/poor gum health in the mouth may be distinguished from areas of acceptable/good gum health).
Regarding Claim 26, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 17 above. Vermeulen et. al.'459 further discloses comprising an indicator configured to provide an indication to a user that blood is present in the oral cavity (Paragraph [0063] - The probe 40 may be equipped with a suitable indicator for issuing a warning signal in case blood appears to be detected).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen et. al.'459 (U.S. Patent Publication 20210315459 – cited by applicant) in view of Yamamoto et. al.'703 (U.S. Patent Publication 20130053703) as evidenced by Miller’893 (U.S. Patent Publication 20100231893), as applied to Claim 1, and further in view of Goodson et. al.'310 (U.S. Patent Publication 20070259310 – previously cited).
Regarding Claim 2, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 1 above, but fails to disclose the plurality of different times are separated by a predetermined period of time. Goodson et. al.’310 teaches applying light at different wavelengths to a user for various amounts of time with a predetermined amount of time set between each light application (Paragraph [0040] - The device can optionally further include a timer that causes the light to turn off once a certain time is reached. The timer can be used to time each light session, and/or measure time between sessions. As such, timers can be used to control the amount of light therapy delivered and to avoid overexposure; Paragraph [0052] - the light is emitted in the oral cavity for a periodic interval (e.g., about 20, 30, 40, or 50 second intervals), and then repeated one, two or three times). 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 Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 to include separating an application of various wavelengths of light by a predetermined amount of time in order to avoid overexposure of said various wavelengths of light on a user as seen in Goodson et. al.’310.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen et. al.'459 (U.S. Patent Publication 20210315459 – cited by applicant) in view of Yamamoto et. al.'703 (U.S. Patent Publication 20130053703) as evidenced by Miller’893 (U.S. Patent Publication 20100231893), as applied to Claim 1 above, and further in view of Tearney et. al.'015 (WO Patent Publication 2006024015 – previously cited) as evidenced by Thomas Veitinger'2011 (Ratiometric Imaging: Analyzing ion concentrations by measuring fluorophore shifts – previously cited).
Regarding Claim 4, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 1 above. Vermeulen et. al.'459 fails to disclose wherein each of the peaks has a corresponding ratio value that meets or exceeds a predetermined threshold value. Tearney et. al.'015 teaches observing intensity-related ratios as a way to estimate a presence of blood (Page 16 lines 17-26 - In blood which is oxygenated, there are several absorption peaks in the visible spectrum, e.g., at 520-590nm and 800-900nm. A simple device may obtain the light scattered back from the catheter at these wavelengths, and compare such light to the light scattered back from an adjacent wavelength where blood absorption is low. This comparison can be accomplished by a linear combination of the intensity of light reflected back by the two wavelengths. For example if R(.lamda..sub.1) is the light reflected back to the catheter on the absorption peak and R(.lamda..sub.2) is the light reflected back to the tissue off of the absorption peak, blood can be estimated by several differential/ratiometric combinations of R(.lamda..sub.1) and R(.lamda..sub.2)). 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 Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 to include ratiometric combinations involving light reflection intensity as a way to identify a presence of blood in order to account for there being high, low, etc. various levels of absorption between blood at various wavelengths as seen in Tearney et. al.'015. Ratiometric combinations are relevant to intensity as evidenced by Thomas Veitinger'2011 that teaches using ratiometric methods includes measuring intensity more than once and creating ratios out of these measurements over a period of time (Page 3 - As mentioned above, in ratiometric imaging an emission shift instead of mere intensity change is imaged. To measure emission shifts, intensity changes of a fluorophore or fluorophore combination have to be measured either by using two different excitation wavelengths or by detecting at two different emission wavelengths; Page 7 Paragraph 2; All ratiometric methods have in common that the intensity of emitted light is measured twice and a ratio (R) of these intensities is calculated; Page 8 Paragraph 1 - In practice, the ratio is calculated by a computer, in many cases online during a time-lapse experiment).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen et. al.'459 (U.S. Patent Publication 20210315459 – cited by applicant) in view of Yamamoto et. al.'703 (U.S. Patent Publication 20130053703) as evidenced by Miller’893 (U.S. Patent Publication 20100231893), as applied to Claim 1, and further in view Aldrich'898 (U.S. Patent 6064898).
Regarding Claim 5, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 1 above, but fails to disclose a processor that is used to identify peaks that are separated from each of the other peaks by at least a predetermined time value. Aldrich’898 teaches accounting for timing between peaks in order to more accurately identify relative signals (Column 8 Lines 66-67 to Column 9 Lines 1-15 - this configuration is used when the substance of interest absorbs very strongly at a particular wavelength relative to all other substances expected to be present in blood, as, for example, with hemoglobin (Hb) at a wavelength of 548 nm (0.548 .mu.m), an isobestic point for oxy-, carboxy-, and reduced hemoglobins…First, two points for analysis are determined, optimally peak systole and nadir diastole. For example, after approximately ten peaks and nadirs of the linear plethysmogram have been identified by the microprocessor, the mean durations between sequential peaks and nadirs are calculated and the times of occurrence of the next peak (systole) and nadir (diastole) are thereby predicted and selected for analysis during subsequent pulses). 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 Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 to include determining an average amount of time expected to occur between hemoglobin-related peaks in order to calibrate a system and more accurately analyze subsequent peaks based on the determined trend as seen in Aldrich’898.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen et. al.'459 (U.S. Patent Publication 20210315459 – cited by applicant in view of Yamamoto et. al.'703 (U.S. Patent Publication 20130053703) as evidenced by Miller’893 (U.S. Patent Publication 20100231893), as applied to Claim 8, and further in view of Shelton et. al.'822 (U.S. Patent Application 20220104822 – previously cited).
Regarding Claim 9, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 8 above. Additionally, Vermeulen identifies applying wavelengths that correspond to green and red light (Paragraph [0024] - a second main wavelength may be in a range of 520-580nm; Paragraph [0063] - In a spectral detection process, two wavelengths are covered: one main wavelength for measuring the absorption of hemoglobin, preferably chosen from a range of 410-430nm, and one auxiliary wavelength chosen from a range where the absorption of hemoglobin is known to be considerably less, such as a wavelength in a range of 440-470nm or a wavelength higher than 650nm), but fails to disclose a third light is infrared light. Shelton et. al.'822 teaches using infrared, green, and red light (Paragraph [0468] - In some non-limiting examples, a near infrared laser source may emit illumination have a wavelength that may range between 750-3000nm, inclusive; [0469] - Near infrared spectroscopy (NIRS) is a non-invasive technique that allows determination of tissue oxygenation based on spectra-photometric quantitation of oxy- and deoxyhemoglobin within a tissue; [0473] - An alternative to near infrared light to determine hemoglobin oxygenation would be the use of monochromatic red light to determine the red light absorbance characteristics of hemoglobin. The absorbance characteristics of red light having a central wavelength of about 660nm by the hemoglobin may indicate if the hemoglobin is oxygenated (arterial blood) or deoxygenated (venous blood); [0491] - For example, light from a green laser may have a central wavelength 2352 within a range of about 520nm to about 532nm. The reflected green light may have a central wavelength 2354 shifted to a longer wavelength (red shifted) if the light was reflected from a particle such as a red blood cell that is moving away from the detector). 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 Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 to include red, green, and infrared wavelengths used as a way to detect blood since in order to potentially increase a chance in detecting blood in a fluid sample since a wider variety of samples would be able to be obtained as seen in Shelton et. al.'822.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen et. al.'459 (U.S. Patent Publication 20210315459 – cited by applicant) in view of Yamamoto et. al.'703 (U.S. Patent Publication 20130053703) as evidenced by Miller’893 (U.S. Patent Publication 20100231893), as applied to Claim 17, and further in view of Iyengar et. al.'961 (U.S. Patent 10827961 – previously cited).
Regarding Claim 19, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 17 above. Additionally, Vermeulen et. al.’459 discloses the sensor is further configured to emit a third light at a third wavelength, receive reflected portions of the third light, and generate a third signal indicative of a third intensity of the reflected portion of the third light (Paragraph [0059] - At the higher wavelength values, the transmission values are mainly influenced by the presence of toothpaste while the blood absorption is very low, whereas at the lower wavelength values, especially the values in the range of 410-430 nm, the contribution of the blood is far more significant. In case a particular type of toothpaste has a color on the basis of which the toothpaste is highly absorbing in the same range of wavelengths as blood, a third measurement value obtained at a third wavelength can be used for further correction);
wherein the processor is further configured to, for the plurality of different times, receive the third signal, and calculate a second ratio of the third intensity to the second intensity (Paragraph [0018] – entire paragraph); and
wherein the predetermined boundaries define a predetermined area, and wherein the processor is configured to identify which of the data points are inside the predetermined area and which of the data points are outside the predetermined area (Paragraph [0040] - In a practical embodiment, the system according to the invention may be equipped with an indicator configured to emit a signal in case the discrimination value is found to be in the range of values indicative of the presence of blood in a sample, i.e. above or below a reference value, whatever the case may be).
Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 fails to disclose each of the data points comprises the ratio of the first intensity to the second intensity as a first coordinate and the second ratio as a second coordinate. Iyengar et. al.'961 teaches wavelength-related ratios represented as coordinates (Column 9 Lines 31-39 - Turning now to FIG. 4, a graph 400 is shown to illustrate example mathematical relationships of the present disclosure. The graph has axes r.sub.1 401, r.sub.2 402, and r.sub.3 403. The coordinates r.sub.1, r.sub.2 and r.sub.3 represent ratios of wavelengths obtained from a noninvasive optical sensor 106 having at least three wavelengths, substantially as discussed above with respect to FIG. 1. Of course, more ratios and more wavelengths can be used and an n-dimensional graph can be generated accordingly). 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 Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 to include manipulating wavelength-related ratios into coordinates in order to create mathematical relationships as an additional way to understand and represent obtained data as seen in Iyengar et. al.’961.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen et. al.'459 (U.S. Patent Publication 20210315459 – cited by applicant) in view of Yamamoto et. al.'703 (U.S. Patent Publication 20130053703) as evidenced by Miller’893 (U.S. Patent Publication 20100231893), as applied to Claim 17, and further in view of DiMaio et. al.'580 (U.S. Patent Publication 20170367580).
Regarding Claim 20, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 17 above, but fails to disclose wherein the determination whether hemoglobin is present is based on vector lengths corresponding to a respective one of the data points outside the predetermined boundaries; and wherein each of the vector lengths is measured from a centroid of the data points inside the predetermined boundaries to the respective one of the data points outside the predetermined boundaries. DiMaio et. al.’580 teaches identifying data points being inside or outside a predetermined boundary utilizing Euclidean distance – vector lengths – from a centroid (Paragraph [0465] - Outlier detection and removal is an important area in statistic and pattern recognition area, which has been used widely in different areas, such as, credit card fraud, interesting sensor events, medical diagnosis; Paragraph [0467] - In proximity-based outlier detection, the nearest neighbor idea can be used to generate an approximation of inclusion or exclusion At first, the concept of distance is important. If there are N samples and M variables, the size of matrix is N*M, and for example by using Euclidean distance, we can calculate the distance among sample space by defined distance by: d(q, p)=√{square root over ((q.sub.1−p.sub.1).sup.2+(q.sub.2−p.sub.2).sup.2+ . . . +(q.sub.m−p.sub.m).sup.2)}. Clustering methods are a common method that employs this concept of distance. In clustering algorithms, we can define a radius w, for any group of points from which a center has be identified (centroid). If the points is less or equal this radius, it could be considered a good point, from which the centroid is updated based on the inclusion of this new data point). 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 Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 to include an outlier detection setup comprising analyzing Euclidean distances – vector lengths – with respect to centroids of data clusters in order to establish boundaries that identify any outliers outside of the boundaries as seen in DiMaio et. al.’580.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen et. al.'459 (U.S. Patent Publication 20210315459 – cited by applicant) in view of Yamamoto et. al.'703 (U.S. Patent Publication 20130053703) as evidenced by Miller’893 (U.S. Patent Publication 20100231893), as applied to Claim 17, further in view of DiMaio et. al.'580 (U.S. Patent Publication 20170367580), and further in view of Kitamura'047 (U.S. Patent Publication 20100208047).
Regarding Claim 21, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 and further in view of DiMaio et. al.'580 discloses the system outlined in Claim 20 above, but fails to disclose the characteristic upon which the determination whether hemoglobin is present is either whether a sum of the vector lengths exceeds a predetermined number; or whether an average of the vector lengths exceeds a predetermined number. Kitamura'047 teaches using a total Euclidean distance greater than a predetermined value to identify a presence of an anomaly - lesion (Paragraph [0006] - As a technology for solving such a problem, a technology for detecting an abnormality observed area (lesion area) from in-vivo images has been proposed. For example, Japanese Laid-open Patent Publication No. 2005-192880 discloses a technology in which clustering is performed by mapping either a pixel value of each pixel of an in-vivo image or an averaged pixel value to a feature space based on color information, and data whose Euclidean distance from a cluster of a normal mucous-membrane area is equal to or larger than a predetermined value is detected as a lesion area). 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 Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 and further in view of DiMaio et. al.'580 to include using a total vector length – Euclidean distance - in order to identify a presence of an anomaly in an area such as a lesion – blood – based on a comparison to “normal” data as seen in Kitamura'047.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Vermeulen et. al.'459 (U.S. Patent Publication 20210315459 – cited by applicant) in view of Yamamoto et. al.'703 (U.S. Patent Publication 20130053703) as evidenced by Miller’893 (U.S. Patent Publication 20100231893), as applied to Claim 22, and further in view of Erlenkoetter et. al.'225 (U.S. Patent Publication 20210060225).
Regarding Claim 23, Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 discloses the system outlined in Claim 22 above. Vermeulen et. al.’459 fails to disclose wherein the spread is based on, for each of the data points within the predetermined boundaries, a distance between at least one of the data points and a centroid of the data points inside the predetermined boundaries. Erlenkoetter et. al.'225 teaches using kurtosis – distribution of data in relation to a centroid - to identify a presence of blood (Paragraph [0055] – Therefore, when determining the residual blood in such a dialyzer, preferably the frequency distribution, or the respective centroid, is identified for the green and/or blue and/or red color channel. By comparing the intensity value of the centroid thereby obtained to the calibration data for the green and/or blue and/or red color channel, a conclusion can then be drawn as to the residual blood content in the dialyzer. Using the green color channel is preferential; Paragraph [0059] - additionally to the centroid or expected value respectively, however, other characteristics of the frequency distributions can also be considered in the residual blood determination / calibration such as, for example, the width, slope and/or kurtosis of the respective distribution). 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 Vermeulen et. al.'459 in view of Yamamoto et. al.'703 as evidenced by Miller’893 to include comparing kurtosis-related data points as a way of calibrating a distribution of data from centroids in order to understand trends in intensity and determine a presence of blood as seen in Erlenkoetter et. al.’225.
Response to Arguments
Applicant's arguments filed 17 March 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior claim objections.
Applicant’s amendments have overcome some of the prior 35 U.S.C. 112b rejections, but current 112b rejections are 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 amended the claims to include the limitation "provide an indication to a user that blood is present in the oral cavity", but as addressed in the Paragraphs above, the examiner notes that this is a form of insignificant extra-solution activity. Additionally, “providing an indication” does not does not effect a particular treatment or effect a particular change. The analysis of the 101 rejection is in Paragraph 4 above.
Claims 1-9 and 17-26 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 5-12 above.
Regarding Claims 5-6 and 20-21, based on the applicant’s amendments, the examiner has cited Aldrich’898, Yamamoto et. al.'703, DiMaio et. al.'580, and Kitamura'047 to teach on the amended limitations as disclosed in Paragraphs 5-12 above.
Regarding Claim 19, it is to be noted that although Iyengar’961 does not explicitly state using a toothbrush, the element that Iyengar’961 is providing to the prior art is not dependent on what type of non-invasive structure is being used. Rather, the element of providing intensity ratios as coordinates is being done by a processor in order to analyze the data. The examiner believes that there are no limitations recited in Iyengar’961 that would restrict this process from being used in a non-invasive system such as a toothbrush.
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
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