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 .
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 7-10, 13, 23-27 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reddy (US Patent No. 11,045,111) in view of Agarwal et al. (US Pub No. 2015/0295562), Frank et al. (US Pub No. 2020/0397306) and Barnes et al. (US Pub No. 2020/0267336).
With regards to claims 7 and 13, Reddy discloses a portable remote apparatus for gathering data related to an individual for testing for the presence of a specific disease or medical condition in the individual or a portable remote screening and disease detecting apparatus (102) for performing a rapid, non-invasive, point-of-care test for detecting the presence of a specific disease or medical condition in an individual (column 1, lines 8-18, referring to a portable breath analyzer for detecting and identifying VOCs in the exhaled breath of a subject or person in real time; column 9, lines 12-19; Figure 1A) comprising:
a portable housing (104) capable of being held in a user’s hand (column 9, lines 12-19, referring to the device (102) being included in a housing (104), wherein the device (102) can be a handheld structure mounted to a smart phoen or a standalone structure, which as needed could be a portable structure; Figure 1A);
one or more sensors (108) contained within the housing (104) for measuring volatile organic compounds (“one or more VOCs”) present in an individual’s breath (“exhaled breath”), oral cavity, and/or skin (column 9, lines 12-19, referring to the sensor module (10*) being included within the housing (104); column 10, line 48-column 11, line 51; Figure 1A); and
a data processor (“biomarker processing module”/”diagnostic module”/”processor of a smart phone and/or remote server”) having a detector for the specific disease or medical condition that is capable of processing volatile organic compound data of the individual to determine if the individual has the specific disease or medical condition (column 8, lines 43-48; column 15, lines 4-48, referring to the biomarker processing module which is operable to process the collected data from the sensor module (108), via a neural network or pattern recognition algorithm, wherein an initial result of the processing can include identification of one or more substances in the exhaled breath, an identification of and/or correlation with a health condition or disease, etc.; column 16, lines 1-18; column 17, lines 6-18; column 17, lines 19-31, referring to the diagnostic module which is operable to determine, based at least in part on the processed data from the biomarker processing module, one or more diagnoses and/or treatments for a subject, wherein the diagnostic module, via one or more processors and/or network and I/O interface, may communicate with the biomarker processing module to receive processed data; Figures 1A-C, 10),
wherein the detector includes a biomarker/signal pattern for the specific disease or medical condition that is obtained by matching volatile organic compounds from the breath, oral cavity, and/or skin of individuals having the specific disease or medical condition and data of the individuals having the specific disease or medical condition (column 11, line 17-51, referring to different cancers/diseases having different and unique smells or odors, wherein when a pattern of a certain number and quantity of substances is associated with a particular health condition or disease, the pattern can be stored by the system for subsequent processing to compare and/or match against patterns of substances detected and identified by a sensor module in an exhaled breath of a subject; column 15, 23-67, referring to the use of a neural network which is trained by receiving and storing any number of previously detected and identified signals and/or signal patterns of one or more substances from the exhaled breath, wherein an example pattern recognition pattern can be an algorithm operable to seek a best match or relatively high confidence score in matching a signal/signal pattern to one or more previously stored signals and/or signals correlated/matched with one or more health conditions (i.e. correlated with individuals having the one or more specific disease or health/medical condition)).
Further, with regards to claim 13, Reddy discloses a data processor with a program application for saving the volatile organic compound data and sending the volatile organic compound data (i.e. via the communication module 110) to a different location (i.e. location other than within the housing (104; see Fig. 1) for detecting the presence of the specific disease or medical condition in the individual (column 9, lines 45-56, referring to the housing 1040 adhering to or in relatively close proximity to the mobile communication device, such as a smart phone, tablet, computer, smart watch, or other wireless communication or computing device, wherein the communication module 110 can facilitate communication between the housing and the mobile communication device via wireless communication technique or protocol, etc.; column 9, lines 58-64, referring to the SD card memory device 112 and is connected to, and can be addressed by, communication module 110; column 16, lines 1-18; column 17, lines 6-31, referring to the diagnostic module which is operable to determine, based at least in part on the processed data from the biomarker processing module, one or more diagnoses and/or treatments for a subject [wherein such determination corresponds to detection of the presence of a specific disease or medical condition), wherein the diagnostic module, via one or more processors and/or network and I/O interface, may communicate with the biomarker processing module to receive processed data; Figures 1A-C, 10).
However, Reddy does not disclose that the data processor is contained within the housing.
Further, Reddy does not specifically disclose that the one or more sensors contained within the housing includes one or more sensors for measuring wavelengths of light emanating from the skin of the individual and wherein the data processor is further capable of processing the measured wavelengths of light from skin of the individual to determine if the individual has the specific disease or medical condition and that the data that is saved and sent to the another location further includes the individual’s wavelengths of light skin imaging data.
Additionally, Reddy does not specifically disclose that the biomarker/signal pattern is specifically “an infrared wave signature” and that the data of the individuals having the specific disease or medical condition specifically corresponds to “skin images”.
Agarwal et al. discloses a portable sensor system (91) that can incorporate a sensor array (90) comprising sensors (25), including sensors of the type that detect volatile organic compounds (VOCs) corresponding to a user’s breath and can be used as biomarkers to identify disease states in human breath (paragraphs [0013], [0052], [0064]-[0065]; Figures 15-16). The sensor system (91) comprises a microcontroller (94), corresponding memory (96), display (98) and a user interface (102), wherein the microcontroller can analyze the sensor data for the corresponding breath status and processes the data using a set of instructions provided to compute a breath status value and save a data and time stamp in memory (96) (paragraph [0065]; Figures 15-16, note that a microcontroller/processor (94) for processing the sensor data is within the housing of the portable sensor system (91)). Results can be both locally displayed on display (98) and wirelessly transmitted to a smart phone, cell phone, computer or other type of personal computing device, and thus data can be transmitted to the user and the user’s selected caregiver (paragraph [0071]). A low power miniaturized wireless sensor system is thus provided (paragraphs [0006]-[0009]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the data processor of Reddy be contained within the housing, as taught by Agarwal et al., in order to be able to provide results locally to a user and provide a low power system (paragraphs [0006]-[0009], [0071]).
However, the above combined references do not specifically disclose that the one or more sensors contained within the housing includes one or more sensors for measuring wavelengths of light emanating from skin of the individual and wherein the data processor is further capable of processing the individual’s wavelengths of light skin sensing data to determine if the individual has the specific disease or medical condition and that the data that is saved and sent to the another location further includes the individual’s wavelengths of light skin imaging data.
Further, the above combined references do not specifically disclose that the biomarker/signal pattern is specifically “an infrared wave signature” and that the data of the individuals having the specific disease or medical condition specifically corresponds to “skin images”.
Frank et al. disclose systems and methods that utilize temperatures measurements taken with head-mounted sensors as well as images of a user’s face/skin to detect fever and/or abnormal medical events, wherein the abnormal medical events may involve the user suffering from an infection, such as COVID-19 and their system/methods provides a relatively inexpensive and unobtrusive way to accurately detect whether a user has a fever and/or is experiencing an abnormal medical event, without interrupting the user’s daily activities (Abstract, paragraph [0014], paragraphs [0013], [0079]-[0080], [0373], [0131]). The system may include a short-wave infrared (SWIR 334) inward-facing head-mounted camera that is configured to detect wavelengths in at least a portion of the range of 700 nm to 2500 nm, wherein the computer (340) is configured to detect whether the user has the fever also based on a deviation of a current SWIR pattern from a baseline SWIR pattern taken while the user did not have a fever (paragraph [0131], note that the SWIR camera serves as a sensor for measuring wavelengths (i.e. “wavelengths in at least a portion of the range 700 nm to 2500nm”) of light emanating from the skin of an individual; Figure 1C). The SWIR-images (335) may be utilized as inputs for a detection of whether the user has a fever, etc. (paragraph [0131]; Figure 1C). The computer (340) bases the detection of whether the user has the infection/fever, etc., based on a deviation of the current pattern from the detected-state pattern (paragraphs [0143]-[0144]). Further, a machine-learning-based model may be personalized for a specific user, wherein, after receiving a verified diagnosis of an extent of a physiological condition (such as extent of a cardiovascular disease, extent of a pulmonary disease, etc.), the computed can use the verified diagnosis as labels and generate from a physiological measurement, (such as the temperature signal, PPG signal, etc.) feature values to train a personalized machine learning-based model for the user (paragraph [0082]-[0083], [0159], note that the computer therefore processes different sets of data (i.e. diagnosis data, temperature data, PPG data, etc.) to determine if an individual has a specific abnormal medical condition/disease). Then the computer can utilize the personalized machine learning based model for future calculations of the extent of the physiological condition based on feature values (paragraphs [0083], [0159]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the one or more sensors of the above combined references include one or more sensors for measuring wavelengths of light emanating from skin of the individual and wherein the data processor is further capable of processing the individual’s wavelengths of light skin sensing data to determine if the individual has the specific disease or medical condition and that the data that is saved and sent to the another location further includes the individual’s wavelengths of light skin imaging data, as taught by Frank et al., in order to provide a relatively inexpensive and unobtrusive way to accurately detect whether a user has a fever and/or is experiencing an abnormal medical event, without interrupting the user’s daily activities (paragraph [0014]).
However, the above combined references do not specifically disclose that the biomarker/signal pattern is specifically “an infrared wave signature” and that the data of the individuals having the specific disease or medical condition specifically corresponds to “skin images”.
Barnes et al. disclose systems and methods that enable the diagnosis of a medical condition in a subject using spectral medical imaging data obtained using any combination of sensor, such as a LIDAR sensor, a thermal imaging sensor, a color sensor, a SWIR sensor, and/or a hyperspectral image sensor, etc., wherein the images may represent information from an infrared region of the electromagnetic spectrum and using information in the hyperspectral image allows for a more accurate diagnosis (Abstract; paragraphs [0044]-[0045], [0076]). The spectral image of the subject is of the subject’s skin of interest and obtaining the hyperspectral image may also include obtaining other types of information about the subject and fusing or combining the information with the hyperspectral image (paragraphs [0048]-[0049]). An indication for a suspect region is obtained by comparing measurements from one or more of the plurality of regions with one or more spectral signatures in a library of spectral signatures, in which each spectral signature in the library corresponds to one or more spectral characteristics of a medical condition (paragraph [0051]). The suspect region is identified when the comparison results in a region that most resembles a spectral signature from the spectral signature library (paragraph [0051]). In some embodiments, measurements of the plurality of regions are resolved into spectra where each spectrum corresponds to a region, wherein the spectrum corresponding to a region is then compared to a signature spectrum corresponding to a medical condition and the signature spectrum is obtained by taking measurements of a region that is known to have the medical condition (paragraphs [0051]-[0052], note that an infrared wave signature [obtained from images] is thus obtained which is correlated/matched to a subject having the medical condition). Data from the hyperspectral image can be compared with existing signatures of signals that correspond to known illnesses or medical conditions (paragraph [0067, note that the image is thus compared to the signals to obtain the signature spectrum). Further, the hyperspectral image is optionally combined or “fused” with other information about the subject, such as combined with output of other types of sensors (paragraph [0077]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the biomarker/signal pattern of the above combined references correspond to specifically “an infrared wave signature” and that the data of the individuals having the specific disease or medical condition further comprise “skin images” (i.e. via combining the data of the above combined references with the images, and thus the skin images in the combination would ultimately be matched with the VOCs of Reddy et al. due to both the skin images and VOCs being matched/correlated to the specific disease or medical condition), as taught by Barnes et al., in order to allow for a more accurate diagnosis (Abstract; paragraphs [0044]-[0045]).
With regards to claims 8 and 24, Reddy discloses that the apparatus further includes an inlet (106, “mouth piece”) for receiving a breath sample from the individual wherein the inlet is connected to the one or more sensors (108) for measuring volatile organic compounds (column 9, lines 12-30, referring to the mouth piece (106) which includes an inlet opening to receive the exhaled breath from the subject and wherein the exhaled breath, when received from the mouth piece, travels toward the sensor module (108); Figure 1A).
With regards to claims 9 and 25, Frank et al. disclose that the one or more sensors for measuring wavelengths of light emanating from the individual’s skin are capable of measuring short wave infrared wavelengths (paragraph [0131], referring to the short-wave infrared (SWIR) camera that is configured to detect wavelengths in at least a portion of the range of 700 nm to 2500nm).
With regards to claims 10 and 26, Frank et al. disclose that the one or more sensors for measuring wavelength of light emanating from the individual’s skin are capable of measuring ultra violet light wavelengths (paragraph [0091], referring to the camera capturing light in the ultra-violet range).
With regards to claims 23 and 30, Reddy discloses that the apparatus further comprises a display screen on an outer surface of the housing for displaying test results (column 15, lines 4-22, referring to presenting the result output to a display associated with a mobile communication device; column 9, lines 45-56, referring to the mobile communication device being a smart phone, table, laptop, smart watch, etc., wherein the housing of the apparatus may adhere to or be in close proximity to the communication device). Agarwal et al. further disclose this limitation (paragraph [0065]; Figures 15-16).
With regards to claim 27, Reddy discloses that the specific disease or medical condition is coronavirus disease and the detector is for the coronavirus disease (i.e. a specific disease/COVID-19) (column 11, line 17-51; column 15, 23-67, referring to the use of a neural network which is trained by receiving and storing any number of previously detected and identified signals and/or signal patterns of one or more substances from the exhaled breath, wherein an example pattern recognition pattern can be an algorithm operable to seek a best match or relatively high confidence score in matching a signal/signal pattern to one or more previously stored signals and/or signals correlated with one or more health conditions; column 17, lines 6-18, referring to one or more signals/signal patterns of multiple substances can be associated with type of infectious disease, such as coronavirus disease 2019 (COVID-19); Figure 10, which depicts that COVID 19-type biomarker VOCs were distinguishable and detectable from health patient VOCs, wherein the COVID-19 biomarker/signature was identified based on comparing the data from patients infected with COVID-19 to data from healthy subjects), and therefore it would follow that the above combined references disclose that the infrared wave signature is for the coronavirus disease that is obtained by matching volatile organic compounds from the breath, oral cavity, and/or skin of individuals having the coronavirus disease and skin images of the individuals having the coronavirus disease (see the rejection of claim 13, wherein the specific disease or medical condition, as disclosed by Reddy, is coronavirus disease).
Claim(s) 22 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reddy in view of Agarwal et al., Frank et al. and Barnes et al. as applied to claims 7 and 13 above, and further in view of Boyden et al. (US Pub No. 2008/0058649).
With regards to claims 22 and 29, as discussed above, the above combined references meet the limitations of claims 7 and 13. However, the above combined references do not specifically disclose that their apparatus further comprises selection or activation buttons contained on an outer surface of the housing for selectively activating one or more of the one or more sensors for measuring wavelengths emanating from the skin of the individual, the one or more sensors for measuring volatile organic compounds present in the individual’s breath, oral cavity and/or skin, or the data processor.
Boyden et al. disclose a handheld device which can be used detect and ablate lesions, wherein the user may use a button (2005) on the handheld device to activate or enable a beam of energy to detect and ablate pathogens and pathological tissue , wherein manual selection of the electromagnetic energy may be performed by manually operating a button on an apparatus/device that controls the emitted wavelength from one or more electromagnetic energy source (paragraphs [0134], [0228]; Figures 26-28).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the apparatus of the above combined references further comprises selection or activation buttons on an outer surface of the housing for selectively activating one or more of the one or more sensors for measuring wavelengths emanating from the skin of the individual, the one or more sensors for measuring volatile organic compounds present in the individual’s breath, oral cavity and/or skin, or the data processor, as taught by Boyden et al., in order to provide the ability to manually select wavelengths and/or manual activation of the device, thereby providing user control of the operations (paragraphs [0134], [0228]).
Response to Arguments
Applicant's arguments filed May 29, 2026 have been fully considered but they are not persuasive.
With regards to claims 7 and 13, Applicant argues that in Barnes, there is no matching of VOCs from the breath, oral cavity, and/or skin of individuals having the specific disease and skin images of individuals having the specific disease to create an infrared wave signature detector as required by Applicant’s claims. Applicant further argues that paragraph [0077] of Barnes does not disclose combining the hyperspectral images with distinctly different information/data such as VOC information/data.
Examiner respectfully disagrees and notes that claims 1 and 13 are rejected under the combination of Reddy, Agarwal, Frank and Barnes, wherein Reddy is relied upon to teach the detector including a “biomarker/signal pattern” for the specific disease or medical condition that is obtained by matching VOCs from the breath, etc. of the individuals having the specific disease/medical condition and “data” of the individuals having the specific disease or medical condition (See rejection of claims 1 and 13). The “data” of Reddy is modified in view of the teachings of Barnes to be combined with the images of Barnes, which would ultimately result in the skin images in the combination of references to be matched with the VOCs of Reddy due to both the skin images and VOCs being matched/correlated to the specific disease/medical condition. Further, with regards to paragraph [0077] of Barnes, Examiner notes that Barnes specifically discloses that “the image can be combined with the output of other types of sensors…” and further paragraph [0049] of Barnes sets forth “obtaining a hyperspectral image also includes obtaining other types of information about the subject….and fusing or otherwise combining that information with the hyperspectral image”. Barnes does not explicitly disclose that the “other types of sensors” and/or “other types of information abo9ut the subject” is limited to only sensors related to measuring various light wavelengths, and therefore Applicant’s argument concerning paragraph [0077] of Barnes is not persuasive.
With regards to Reddy, Applicant argues that Reddy fails to disclose an infrared wave signature detector for a specific disease or medical condition where the infrared signature detector is obtained by matching VOCs from breath, etc., having the specific disease and skin images of individuals having the specific disease as required by Applicant’s claims.
However, claims 1 and 13 are rejected under the combination of Reddy, Agarwal, Frank and Barnes. Examiner respectfully refers Applicant to the rejection of claim 1 wherein it is clear that Reddy is not relied upon to teach an “infrared wave signature detector”, etc., but rather it is the combination of references that meet this limitation.
With regards to Frank, Applicant argues that there is no disclosure in Frank of using one or more sensors for measuring wavelengths of light emanating from the skin of an individual to determine if the individual has a specific disease or medical condition.
Examiner respectfully disagrees and note that the Abstract and at least paragraphs [0131] and [0133] of Frank do disclose using one or more sensors (i.e. camera with a short-wave infrared sensor, which corresponds to a sensor for measuring wavelengths of light) to detect whether a user has a fever, wherein having a fever can be viewed as a medical condition as it can be a symptom of infection diseases, such as COVID-19, etc., as recognized by Frank in paragraph [0013]). Further, it is noted that paragraph [0131] of Frank sets forth “In some embodiments, at least some of the feature values, described further below, which are generated based on images from among the images 333 may be generated for the SWIR-images 335. Thus, SWIR-images 335 may be utilized, in some embodiments, as inputs for detection of whether the user has a fever…”, wherein paragraph [0182] of Frank further sets forth “In addition to detecting whether the user has a fever…, in some embodiments, the computer 340 may utilize the images 333 to detect additional physiological signals and/or conditions.” and further paragraph [0379] sets forth that feature values may be used to reflect the fact that an asymmetrical change to blood flow has occurred, wherein an abnormal medical event can be a medical condition such as a headache or inflammatory conditions, such as ear infection, etc., as set forth in paragraphs [0372]-[0373] of Frank. Therefore, Frank does disclose using one or more sensors (i.e. SWIR sensors) for measuring wavelengths of light emanating from the skin of an individual to determine if the individual has a specific disease (i.e. infectious diseases, such as COVID-19) or medical condition (i.e. fever, headache, inflammatory conditions, ear infection, etc.). Additionally/alternatively, it is noted that claim 7 specifically sets forth that the data processor is “capable” of processing the measured wavelengths of light from the skin of the individual, etc. to determine if the individual has the specific disease or medical condition. Applicant should note that any processor has the “capability” for performing processing functions, including processing the measured wavelengths as claimed.
Applicant further assets that neither Barnes, Reddy, Frank nor Agarwal disclose a detector that includes an infrared wave signature for a specific disease where the infrared wave signature is obtained by matching volatile organic compounds from the breath, oral cavity, and/or skin of individuals having the specific disease and skin images of the individuals having the specific disease.
Examiner respectfully disagrees and notes that, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner refers Applicant to the above rejection which sets forth how the combination of references meet the above limitation.
Conclusion
THIS ACTION IS MADE FINAL. 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 KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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