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 .
Response to Amendment
This action is in response to the remarks filed on 11/14/2025 have been entered. Accordingly Claims 1 and 4-20 are pending. Claims 15-20 are withdrawn as described in Election/Restrictions section of previous action.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claim 1 limitation recites “…the presence of a virus having a protective lipid envelope…” while the specification states: “a COVID particle becomes airborne, it forms a protective envelope of a lipid surfactant similar to soap. Like soap bubbles, this protective envelope reflects light.”, analogous recitation is found in claim 9.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 4-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The enablement requirement is described within Section 2164 and the test of enablement is described thereafter in Section 2164.01. The question regarding enablement is as follows: is the experimentation needed to practice the invention undue or unreasonable? In other words, the test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation.
The following is found in Section 2164.01(a) of the MPEP:
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The nature of the invention
The nature of the invention relates to a device for testing a subject’s breath for the presence of coronavirus. The claims at issue recite “A device which tests a subject's breath for the presence of a virus having a protective lipid envelope…”. The claims encompass a device for testing a subject’s breath through a passage such that sensor(s) can “measure the amount of light produced” by a light source which “is reflected into the sensor(s) from virus particles”.
The specification does not provide support of how the device specifics distinguish between various viruses, if all viruses carry properties of reflective light, the distinctions of reflective light between the viruses or how the overall process from an individual’s breath that forms into a protective lipid envelope that a sensor measures light extracted from the breath from which virus vs. non-virus is designated. The specification does not provide any peer review or scientific evidence of the recited device and process of “testing a subject’s breath for the presences of a virus” using just a sensor that is positioned “to measure the amount of light produced by the light source which is reflected into the sensor(s) from virus particles.”. The specification does not provide evidence of the device functional performance to distinguish a breath with the presence of virus from a breath with non-virus presence.
The state of the prior art
The prior art recognized to be useful for detection of data changes that can be correlated to symptoms of inflammatory responses which can include virus such as COVID are provided below. The prior art do not provide general establishment of devices that shine a light on a subject’s breath and use sensor(s) to measure the reflected light to be an amount of virus particles in the subject’s breath.
The most relevant prior art are:
Kim et al. (Sensitive Detection of Multiple Fluorescence Probes based on Surface-enhanced Raman Scattering (SERS) for MERS-CoV, 2019). Teaches a system that contains an analytes separation method and SERS platform for accurate multiplex viral nucleic acid detection for diagnosis of MERS.
Van Der Graaf (U.S. 20190105421) teaches an air treatment device that deactivates bacteria and/or viruses from the air. A sensor such as temperature measures the ambient temperature and providing deactivating material to the airspace to deactivate and thus reducing a detected bacteria or virus material in the air.
Takenaka et al. (“Airborne virus detection by a sensing system using a disposable integrated impaction device.” 2016). Teaches a system that consists of a sampling bag, disposable device, fluorescence detector, aspiration pump and valves as shown in Figs. 1 and 2. The fluorescence detector detects background light from biological aerosol particles from a person’s breath on a collection plate.
Laty U.S. 20210330831 teaches an antivirus and radiation detection system that includes “…ultraviolet light element 118 and/or laser pulsing element 120 are configured to include a light emitting mechanism, such as a LED, configured to be allocated on mask body 102 in an external manner in which the light emitting mechanism is configured to at least partially encircle filter element 114 and/or filter media 116 allowing the light emitting mechanism to externally emit a plurality of colors based on the function ultraviolet light element 118 and/or laser pulsing element 120 is performing while simultaneously being proximate to filter element 114 and/or filter media 116.” [0030].
In addition to the prior art previously provided:
Miller et. al. (U.S. 20210321904) which teaches a breath collection device that can “…detect changes associated with pathogenesis of a disease, such as COVID-19, including biomarkers of immune response for respiratory symptoms, central nervous system injury, and/or peripheral nervous system injury in user breath and/or odor.” (Abstract); “…the breath collection device 100 can be configured to detect, from a user's exhaled breath, a variety of gasses like acetone, hydrogen, NO, alcohol, and carbon monoxide that can be indicators of disease-related infection and symptoms…a sample of the user's breath can be collected in a chamber where gas sensors can detect voltage changes when the sensors contact a COVID-19 gas in the breath sample…A resulting pattern can be identified from the voltage changes…the disclosed technology can determine a volatile organic compound (VOC) signature of respiratory/neurological diseases such as COVID-19 from a plurality of exhaled biomarkers over time…A mucus film can be applied to the sensors of the device 100 to provide a rapid, accurate, sensitive, selective detection of VOCs, such as the aforementioned, hydrogen, CO, NO, Alcohol, and Acetone that are associated with some symptoms of COVID-19. Thus, the disclosed device 100 can be used for detecting levels of VOCs specific to SARS-CoV-2.” [0038]; “…the breath collection device 100 can include a light emitting diode (LED) that can indicate detection of gas concentrations associated with COVID-19. For example, carbon monoxide emitted from a non-COVID-19 breath sample can have a concentration range between 2 ppm-100 ppm, corresponding to a “healthy” signature. When the sensor 1 (e.g., the MQ-2 sensor described herein) detects a concentration value of carbon monoxide emitted from the breath having a value over 100 ppm, a red LED of the breath collection device 100 can illuminate to indicate a potential inflammatory response symptom of COVID-19.” [0054]
Abumeeiz et. al. (“Use of Breath Analysis for Diagnosing COVID-19: Opportunities, Challenges, and Considerations for Future Pandemic Responses.” 2021), teaches a breathalyzer that analyzes the volatile organic compounds (VOCs) in exhaled breath and relates them to “diseases and other biological mechanics.” (Background). Sensors that are reactive to different ranges of VOCs are used to identify the compounds within the breath sample (see Table 1).
Adams et al. (WO2022020505, PG-PUB U.S. 20220022772), which teaches a respiratory diagnosis and therapy system. The handheld device collects data associated with a person’s breathing and analyzes using sensors to determine health-related vitals and generate therapies. The device “…where the pulse oximeter sensor 108 contacts the user's lip when the user places mouthpiece 106 into their mouth, may allow the pulse oximeter sensor 108 to achieve optimal or substantially optimal accuracy when collecting data and computing pulse oximetry and oxygen saturation levels for the user…the handheld respiratory device 100 may be adjusted to accommodate sensors on these other body parts to collect data regarding temperature, SpO2, and others.” [0045]; “…the accessible compilation of capillaries in the lip provide an ideal part of the body for infrared and/or near visible LEDs to transmit to and through the lips of the user. The reflective nature of the lips allow for reflectance pulse oximetry where a photodetector of the pulse oximeter sensor can accurately capture the transmitted light and collect accurate data associated with pulse oximetry of the user…” [0046].
Townsend et. al. (U.S. 20210299288) teaches a virus attenuator attached with a rebreathing mask such that “Heated gas, such as atmospheric air, pure oxygen, or a high-oxygen gas blend, from virus attenuator 10 is supplied to mask 2…Housing 12 has an interior and includes at least one intake port, illustrated as multiple intake ports 11, fluidly coupled to the interior and indicator lamps configured to indicate therapeutic range achievement, illustrated in the form of green LED indicator 17 and red LED indicator 18…” [0052].
The level of one of ordinary skill and the amount of direction provided by the inventor
Despite this lack of specificity to measurement, the specification fails to provide direction or guidance with respect to coronavirus measurement. Since breath reflection brightness can be elevated in a wide variety of viruses, it is not apparent how measurement of light reflection could be used to measure any one out of the numerous possibilities. One of ordinary skill in the art would not know, upon observing reflected light brightness in an asymptomatic subject (for example), whether to confer a diagnosis of virus and what form of virus since the specification indicates that airborne particles form a lipid surfactant but only ties to when COVID becomes airborne but does not address airborne viruses within the same RNA virus family of the coronavirus.
The existence of working examples
No working example is provided.
The quantity of experimentation needed to practice the invention based on the content of the disclosure
In the instant case, the specification does not enable one to measure the amount of light produced by a source reflected into sensor(s) that are virus particles in the breath, since data is not provided nor support established of quantitative or qualitative information that would define the boundary between a positive and negative test, such as voltage changes, chemical or molecular correlations, oxygen saturation and/or oximetry, which are recognized in the art to be various requirements for measurement markers. Consequently, one skilled in the art would face an undue burden of using light produced by a light source reflected into a sensor to measure coronavirus particles in an individual’s breath.
In light of the above factors, it is asserted that a person of ordinary skill in the art would not be able to make or use the invention of claim 1 without undue experimentation and therefore fails the enablement requirement set forth in 35 U.S.C. 112(a).
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 and 4-14 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, and analogous claim 9, it is unclear how the breath translates to virus having a protective lipid envelope. It is unclear if all individual’s breath that are virus positive have a protective lipid envelope or is this intended for specific viruses. The metes and bounds are unclear.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 7-10 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams et al. (WO2022020505, PG-PUB U.S. 20220022772)(hereinafter, “Adams”).
Regarding Claim 1, Adams teaches: A device which tests a subject's breath from the presence of a virus having a protective lipid envelope (See Figs. 4 and 8; “Collecting temperature data at temperature sensor 418 may allow the device to determine if the user has a fever, which may be a factor in determining whether the user has certain conditions, such as COVID-19.” [0054]) comprising:
(a) an enclosure with a passage through which the subject's breath passes (Figs. 4 and 8, “…a user may breathe into air chamber 104 of handheld respiratory device 100 via mouthpiece 106 during an exhale. Air from the user's breath travels through mouthpiece 106 and through air chamber 104.” [0055]);
(b) a light source positioned to shine through the subject's breath as the subject's breath passes through the passage (“Pulse oximeter sensor 108 captures data from user 850 by using a red LED and/or an infrared LED (other types of LEDs may also be used as a part of pulse oximeter sensor 108) to reflect light off of tissues of the user's lip lower 854.” [0079]);
(c) one or more sensors positioned so as to measure the amount of light produced by the light source which is reflected into the sensor(s) (“Pulse oximeter sensor 108 may then capture spikes (e.g. peaks and/or troughs) related to blood flow. Pulse oximeter sensor 108 may capture this raw data in the form of a reflected spectrum, which is proportional to the amount of oxygen in the blood. For example, spikes in the data spectrum may represent high or low amounts of oxygen because blood with low oxygen may reflect the LEDs less, while blood with more oxygen may reflect the LEDs more, relative to each other.” [0079]);
(d) a wireless means to communicate externally (“The handheld respiratory device is a smart device in that the device may connect to other devices or networks via Bluetooth or other wireless protocols and may operate interactively with the user and autonomously to train and/or apply therapy to the user after analyzing the user's breaths.” [0038]).
Regarding Claim 4, Adams teaches the claim limitations as noted above.
Adams further teaches: wherein the enclosure with a passage through which the subject's breath passes comprises a disposable tube inserted in the passage (“…main electronics housing 102 may include a pressure sensor and related components, such as an air chamber pressure tube, an ambient pressure reference tube, etc.” [0043]).
Regarding claim 7, Adams teaches the claim limitations as noted above.
Adams further teaches: further comprising a linked smart-phone app (“The handheld respiratory device is a smart device in that the device may connect to other devices or networks via Bluetooth or other wireless protocols and may operate interactively with the user and autonomously to train and/or apply therapy to the user after analyzing the user's breaths.” [0038]; “The GUI may also be a part of a separate device, such as a smartphone, tablet, smartwatch, or others. Alternatively, the core body temperature may be transmitted to a user at a user device (e.g., smart phone, smart watch, tablet, computer, etc.).” [0057]).
Regarding claim 8, Adams teaches the claim limitations as noted above.
Adams further teaches: wherein the linked smart-phone app comprises data for GPS geolocation for contact tracing (“…handheld respiratory device 100 (or handheld respiratory device 1700) may include a GPS sensor that allows the handheld respiratory device to use its location and collect data associated with its location (e.g., weather, temperature, altitude, climate, etc.) as part of calculating metrics as described herein, and/or developing trainings for a user. Furthermore, the GPS sensor may allow authorities (e.g., police, ambulance, etc.) to find a user if the handheld respiratory device 100 (or 1700) detects an urgent health condition of a user, such as a heart attack.” [0051]).
Regarding claim 9, the claim limitations are the intended usage of Claim 1, since the references cited in Claim 1 have system and methods capabilities, the limitations are as such rejected under the same rationale.
Adams teaches: A method for testing a subject's breath for the presence of a virus having a protective lipid envelope (“This application relates to handheld respiratory diagnostic, training, and therapy devices and methods.” [0038]; See Figs. 4 and 8; “Collecting temperature data at temperature sensor 418 may allow the device to determine if the user has a fever, which may be a factor in determining whether the user has certain conditions, such as COVID-19.” [0054]), comprising:
providing a device which tests for the presence of a virus having a protective lipid envelop in the subject's breath which comprises an enclosure with a passage through which the subject's breath passes (Figs. 4 and 8, “…a user may breathe into air chamber 104 of handheld respiratory device 100 via mouthpiece 106 during an exhale. Air from the user's breath travels through mouthpiece 106 and through air chamber 104.” [0055]),
a light source positioned to shine through the subject's breath as the subject's breath passes through the passage (“Pulse oximeter sensor 108 captures data from user 850 by using a red LED and/or an infrared LED (other types of LEDs may also be used as a part of pulse oximeter sensor 108) to reflect light off of tissues of the user's lip lower 854.” [0079]),
one or more sensors positioned so as to measure the amount of light produced by the light source which is reflected into the sensor(s) from coronavirus virus particles in the subject's breath (“Pulse oximeter sensor 108 may then capture spikes (e.g. peaks and/or troughs) related to blood flow. Pulse oximeter sensor 108 may capture this raw data in the form of a reflected spectrum, which is proportional to the amount of oxygen in the blood. For example, spikes in the data spectrum may represent high or low amounts of oxygen because blood with low oxygen may reflect the LEDs less, while blood with more oxygen may reflect the LEDs more, relative to each other.” [0079]),
and a wireless means to communicate (“The handheld respiratory device is a smart device in that the device may connect to other devices or networks via Bluetooth or other wireless protocols and may operate interactively with the user and autonomously to train and/or apply therapy to the user after analyzing the user's breaths.” [0038]);
having a subject exhale into the enclosure with a passage through which the subject's breath passes while the device shines LED light crosswise to the subject's breath flowing through the breath passage (“…the handheld respiratory device 100 may determine a user's vital lung capacity, peak flow (i.e. the elasticity of respiratory muscles and the severity of pneumonia, for example), temperature (via exhaled breath thermometry), oxygen saturation (SpO2), heart rate, and exhaled carbon dioxide levels (pCO2, as measured in millimeters of mercury, or mmHg, which may be captured by a pCO2 sensor). To collect data associated with, and to use to calculate, these diagnostic biometrics, handheld respiratory device 100 includes various sensors. The sensors may include a pulse oximeter sensor (such as pulse oximeter sensor 108 shown in FIG. 1B), a pressure sensor, a temperature sensor, an oxygen (O2) sensor, a ketone sensor, a nitric oxide sensor, among others.” [0050];
sensing the intensity of the light reflected, and analyzing the reflected light to determine whether the subject is negative or positive for the virus having a protective lipid envelope (“…a CO2 sensor path 2276, which is generated by an IR beam/fan of light at a range of infrared wavelengths (e.g., black-body radiation) transmitted by a CO2 sensor emitter 2274 to CO2 sensor 2272. CO2 absorbs a specific wavelength of light/infrared (4.26 microns) it comes into contact with. When a user breathes into handheld respiratory device 1700, the CO2 from the user's breath absorbs such light as well. Therefore, the CO2 from the user's breath may absorb infrared from the IR beam transmitted from the CO2 sensor emitter 2274.…CO2 sensor 2272 includes two sensors, each with filters. One sensor at the CO2 sensor 2272 has a filter (e.g., glass filter) so that that sensor detects only the specific wavelength of light captured by the CO2 from the user's breath (i.e., 4.26 microns). The other sensor at the CO2 sensor 2272 has a filter that detects only a specific wavelength (e.g., 3.91 microns, which is not impacted by the CO2 from the user's breath) of light that is different than the one captured by the CO2.” [0131-0132]).
Regarding Claim 10, Adams teaches the claim limitations as noted above.
Adams further teaches: wherein the enclosure with a passage through which the subject's breath passes comprises a disposable tube inserted in the passage (“…main electronics housing 102 may include a pressure sensor and related components, such as an air chamber pressure tube, an ambient pressure reference tube, etc.” [0043]).
Regarding claim 13, Adams teaches the claim limitations as noted above.
Adams further teaches: further comprising a linked smart-phone app (“The handheld respiratory device is a smart device in that the device may connect to other devices or networks via Bluetooth or other wireless protocols and may operate interactively with the user and autonomously to train and/or apply therapy to the user after analyzing the user's breaths.” [0038]; “The GUI may also be a part of a separate device, such as a smartphone, tablet, smartwatch, or others. Alternatively, the core body temperature may be transmitted to a user at a user device (e.g., smart phone, smart watch, tablet, computer, etc.).” [0057]).
Regarding claim 14, Adams teaches the claim limitations as noted above.
Adams further teaches: wherein the linked smart-phone app comprises data for GPS geolocation for contact tracing (“…handheld respiratory device 100 (or handheld respiratory device 1700) may include a GPS sensor that allows the handheld respiratory device to use its location and collect data associated with its location (e.g., weather, temperature, altitude, climate, etc.) as part of calculating metrics as described herein, and/or developing trainings for a user. Furthermore, the GPS sensor may allow authorities (e.g., police, ambulance, etc.) to find a user if the handheld respiratory device 100 (or 1700) detects an urgent health condition of a user, such as a heart attack.” [0051]).
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.
Claims 5-6 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Miller et. al. (U.S. 20210321904)(hereinafter, “Miller”).
Regarding claim 5, Adams teaches the claim limitations as noted above.
Adams does not explicitly teach: further comprising a purging fan.
Miller in the field of breath collection-based systems for change detection in associated pathogens teaches: “ A filtration system can also be connected to the second check valve 14 to filter purged air out of the chamber within the housing 11.” [0068]; “Once the breath sample collection is completed (e.g., the sensors detect VOC concentrations), the chamber within the device can be purged with compressed air in 1016.” [0079]; “ The purged air can be filtered out through the second valve in the device in 1018. A filtration system can be attached to the second valve…” [0080]. See e.g. Fig. 2A.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Adams to include a purging fan as taught in Miller to remove any remaining bacteria and filter purged air (Miller, [0068]).
Regarding claim 6, the combination of Adams and Miller teach the claim limitations as noted above.
With regards to limitations: further comprising a filter to capture virus particles drawn into the purging fan, Adams further teaches: “CO2 sensor 2272 includes two sensors, each with filters. One sensor at the CO2 sensor 2272 has a filter (e.g., glass filter) so that that sensor detects only the specific wavelength of light captured by the CO2 from the user's breath (i.e., 4.26 microns). The other sensor at the CO2 sensor 2272 has a filter that detects only a specific wavelength (e.g., 3.91 microns, which is not impacted by the CO2 from the user's breath) of light that is different than the one captured by the CO2.” [0132].
Adams does not explicitly teach: the purging fan.
Miller in the field of breath collection-based systems for change detection in associated pathogens teaches: “ A filtration system can also be connected to the second check valve 14 to filter purged air out of the chamber within the housing 11.” [0068]; “Once the breath sample collection is completed (e.g., the sensors detect VOC concentrations), the chamber within the device can be purged with compressed air in 1016.” [0079]; “ The purged air can be filtered out through the second valve in the device in 1018. A filtration system can be attached to the second valve…” [0080]. See e.g. Fig. 2A.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to include the purging fan as taught in Miller to remove any remaining bacteria and filter purged air (Miller, [0068]).
Regarding claim 11, Adams teaches the claim limitations as noted above.
Adams does not explicitly teach: further comprising a purging fan.
Miller in the field of breath collection-based systems for change detection in associated pathogens teaches: “ A filtration system can also be connected to the second check valve 14 to filter purged air out of the chamber within the housing 11.” [0068]; “Once the breath sample collection is completed (e.g., the sensors detect VOC concentrations), the chamber within the device can be purged with compressed air in 1016.” [0079]; “ The purged air can be filtered out through the second valve in the device in 1018. A filtration system can be attached to the second valve…” [0080]. See e.g. Fig. 2A.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Adams to include a purging fan as taught in Miller to remove any remaining bacteria and filter purged air (Miller, [0068]).
Regarding claim 12, the combination of Adams and Miller teach the claim limitations as noted above.
With regards to limitations: further comprising a filter to capture virus particles drawn into the purging fan, Adams further teaches: “CO2 sensor 2272 includes two sensors, each with filters. One sensor at the CO2 sensor 2272 has a filter (e.g., glass filter) so that that sensor detects only the specific wavelength of light captured by the CO2 from the user's breath (i.e., 4.26 microns). The other sensor at the CO2 sensor 2272 has a filter that detects only a specific wavelength (e.g., 3.91 microns, which is not impacted by the CO2 from the user's breath) of light that is different than the one captured by the CO2.” [0132].
Adams does not explicitly teach: the purging fan.
Miller in the field of breath collection-based systems for change detection in associated pathogens teaches: “ A filtration system can also be connected to the second check valve 14 to filter purged air out of the chamber within the housing 11.” [0068]; “Once the breath sample collection is completed (e.g., the sensors detect VOC concentrations), the chamber within the device can be purged with compressed air in 1016.” [0079]; “ The purged air can be filtered out through the second valve in the device in 1018. A filtration system can be attached to the second valve…” [0080]. See e.g. Fig. 2A.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to include the purging fan as taught in Miller to remove any remaining bacteria and filter purged air (Miller, [0068]).
Response to Arguments
With regards to Applicant’s arguments regarding the specification objection: “Applicants respectively submit that persons of skill in the art would understand the language recited in the specification relating to protective envelopes refers to a virus having a protective lipid envelope.” Examiner respectfully disagrees that the language in the recited claim is analogous and provides proper antecedent basis for the claimed subject matter, as previously provided and provided above, “claim 1 limitation recites “…the presence of a virus having a protective lipid envelope…” while the specification states: “a COVID particle becomes airborne, it forms a protective envelope of a lipid surfactant similar to soap. Like soap bubbles, this protective envelope reflects light.”, analogous recitation is found in claim 9.”, the specification is directed to a narrower, specific class of airborne particles forming a protective envelope unlike the limitations in the recited claims.
With regards to Applicant arguments regarding 35 U.S.C. 112(a): “The Office Action states that the "claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Applicants respectfully submit that determining the presence or absence of virus having a protective lipid envelope through the measurement of reflected light would be understood by persons of skill in the device detects the presence of viruses comprising lipid envelopes because the airborne virus reflects light and the brightness of the reflection is proportional to the reflecting surface area arising from concentration of virus in the subject's breath and that comparison with a standard, breath without virus, would be understood by persons of skill in the art. This is described at least at [0011]-[0012] of the application. Applicants respectfully submit that this rejection has been overcome and request reconsideration and withdrawal of this rejection.” (Remarks, pgs. 2-3).
Examiner again respectfully disagrees that the Specification provides sufficient support, as provided previously, “The specification does not provide sufficient support on how the components such as the sensor(s) and light source measure light reflections in a subject’s breath in order to identify virus particles versus other particles with only a reasonable amount of experimentation to arrive at what Applicant says invention has solved (See MPEP 2164.06). As provided in the above office action “…One of ordinary skill in the art would not know, upon observing reflected light brightness in an asymptomatic subject (for example), whether to confer a diagnosis of virus and what form of virus since the specification indicates that airborne particles form a lipid surfactant but only ties to when COVID becomes airborne but does not address airborne viruses within the same RNA virus family of the coronavirus.”. Further, Applicant simply stating that something would be clear to one of ordinary skill in the art without enough evidence under MPEP 2145 is not sufficient, “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc). Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).”
With regards to Applicant arguments regarding 35 U.S.C. 112(b): “The Office Action states that it is unclear how the breath translates to virus having a protective lipid envelope in claims 1 and 9. Applicants respectfully submit that persons of skill in the art would understand from the specification that, as recited in the specification, at [0011] "[the] protective envelope reflects light. The brightness of this reflection is proportional to the reflecting surface area arising from COVID concentration in the subject's breath" and that once this brightness is compared with non-virus containing sample, or breath, the presence of virus having a protective lipid envelope can be detected. Applicants respectfully submit that this rejection has been overcome and request reconsideration and withdrawal of this rejection.”
Examiner again respectfully disagrees that the Specification provides sufficient support and that one of ordinary skill in the art would understand from the specification. Applicant simply stating that something would be clear to one of ordinary skill in the art without enough evidence under MPEP 2145 is not sufficient, “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc). Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
With regards to Applicant arguments regarding 35 U.S.C. 102/103: “Applicants respectfully submit that Adams has no disclosure relating to reflecting light from virus particles and determining the presence of virus particles having a protective lipid envelope as recited in independent claims 1 and 9.” (Remarks, pg. 3).
Examiner again respectfully disagrees, Adams as provided in the above sections is directed to determining conditions such as COVID’19 [0054] utilizing breath analysis and various led (i.e. light) reflectance data [0055][0079]. Applicant’s arguments are respectfully a narrower interpretation to the recited claim subject matter.
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.
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798