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 .
Claims 1-29, filed 3/11/22, are currently pending.
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, while also correcting the claim objection below.
Specification
The disclosure is objected to because of the following informalities: “sensors 120” in paragraph 38, line 6 should be corrected to --sensors 130-- for consistency. Appropriate correction is required.
Claim Objections
Claims 15-17 are objected to because of the following informalities:
Claim 15 recites “the measured metric” suggested to be changed to --the measured breath metric-- for consistency.
Claims 16 (line 2) and 17 (line 10) recites “the metric” suggested to be changed to --the breath metric-- for consistency. Appropriate correction is required.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a mask component…configured to fit” in claim 1, “a fan unit configured…” in claim 1, “a respiratory analysis module…” in claim 1, “display element configured to…” in claim 15, “drug delivery feature configured to…” in claim 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 25-29 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.
Claim 25 recites “the filtered air” in line 4, which lacks proper antecedent basis.
Any remaining claims are rejected as being dependent on a rejected base claim.
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 1-15 and 17-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-15 and 17-29 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Claims 1-15 recite measure a breath metric associated with the user's exhalation gases; and a respiratory analysis module storing instructions that, when executed, automatically adjust a value of the measured breath metric to provide a corrected value that accounts for a dilution of the user's exhalation gases in the breathing chamber and claims 17-24 recite measuring, via the sensor, a value of the breath metric in chamber gases during an exhalation phase of the user's breath, wherein the chamber gases include patient exhalation gases and atmospheric air; calculating a corrective factor, wherein the corrective factor corresponds to a ratio between the patient exhalation gases in the chamber gases and the atmospheric air in the chamber gases; and applying the corrective factor to the measured value of the metric to determine a corrected value of the breath metric and claims 25-29 recite measuring a value of a breath metric associated with the user's exhalation gases during the exhalation phase of the user's breath, which are grouped as a mathematical concept and mental process under the 2019 PEG (see MPEP 2106.04(a)). Accordingly, each of Claims 1-15 and 17-29 recites an abstract idea.
Specifically, independent Claim 1 recites (additional elements are in bold, abstract ideas are underlined): A respirator system, comprising: a mask component defining a breathing chamber, wherein the mask component is configured to fit at least partially over a user's face with a gap between a periphery of the mask component and the user's face; a fan unit configured to deliver external air to the breathing chamber; a sensor coupled to the mask component, wherein the sensor is configured to (i) be at least partially spaced apart from the user's mouth across the breathing chamber, and (ii) measure a breath metric associated with the user's exhalation gases; and a respiratory analysis module storing instructions that, when executed, automatically adjust a value of the measured breath metric to provide a corrected value that accounts for a dilution of the user's exhalation gases in the breathing chamber.
Specifically, independent Claim 17 recites (additional elements are in bold, abstract ideas are underlined): A method of determining a breath metric of a user wearing an open respiratory device having a sensor spaced apart from the user's mouth by a breathing chamber, the method comprising: measuring, via the sensor, a value of the breath metric in chamber gases during an exhalation phase of the user's breath, wherein the chamber gases include patient exhalation gases and atmospheric air; calculating a corrective factor, wherein the corrective factor corresponds to a ratio between the patient exhalation gases in the chamber gases and the atmospheric air in the chamber gases; and applying the corrective factor to the measured value of the metric to determine a corrected value of the breath metric.
Specifically, independent Claim 25 recites (additional elements are in bold, abstract ideas are underlined): A method of determining a breath metric of a user wearing an open respiratory device having a sensor spaced apart from the user's mouth by a breathing chamber, the method comprising: delivering atmospheric air to the breathing chamber, wherein delivering the filtered air provides a positive pressure in the breathing chamber; stopping delivery of the filtered atmospheric air to the breathing chamber during an exhalation phase of the user's breath; measuring a value of a breath metric associated with the user's exhalation gases during the exhalation phase of the user's breath; and after measuring the value of the breath metric, restarting delivery of the atmospheric air to the breathing chamber.
The abstract ideas indicated by the underlined sections involve observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-15, 18-24 and 26-29 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Specifically, Claim 2 recites (additional elements are in bold, abstract ideas are underlined): wherein: the instructions, when executed, cause the respiratory analysis module to: receive an air supply rate corresponding to a rate of the external air provided to the breathing chamber by the fan unit; receive a pressure value corresponding to a pressure in the breathing chamber; and based at least in part on the air supply rate and the pressure value, calculate a corrective factor, wherein the corrective factor is applied to the measured breath metric to provide the corrected value.
Specifically, Claim 3 recites (additional elements are in bold, abstract ideas are underlined): the instructions, when executed, further cause the respiratory analysis module to: calculate, based at least in part on the received pressure value, an exhalation gas flow rate corresponding to the user's exhalation gases; and based at least in part on the air supply rate and the exhalation gas flow rate, calculate the corrective factor.
Specifically, Claim 4 recites (additional elements are in bold, abstract ideas are underlined): the sensor is a first sensor, the system further comprising a second sensor configured to determine the air supply rate and a third sensor configured to determine the pressure value.
Specifically, Claim 5 recites (additional elements are in bold, abstract ideas are underlined): the mask component includes a frame and a shield, and wherein the sensor is coupled to the frame and/or the shield.
Specifically, Claim 6 recites (additional elements are in bold, abstract ideas are underlined): the sensor is coupled to a central portion of the frame and/or the shield positionable in front of the user's mouth.
Specifically, Claim 7 recites (additional elements are in bold, abstract ideas are underlined): a housing having a valve moveable between an open position in which an interior of the housing is in fluid communication with the breathing chamber and a closed position in which the interior of the housing is fluidly isolated from the breathing chamber, wherein the sensor is positioned within the housing.
Specifically, Claim 8 recites (additional elements are in bold, abstract ideas are underlined): the valve is configured to be in the open position during an exhalation phase of the user's breath.
Specifically, Claim 9 recites (additional elements are in bold, abstract ideas are underlined): the valve is configured to be in the closed position during an inhalation phase of the user's breath.
Specifically, Claim 10 recites (additional elements are in bold, abstract ideas are underlined): the valve is configured to automatically move between the open and closed positions based on a pressure in the breathing chamber.
Specifically, Claim 11 recites (additional elements are in bold, abstract ideas are underlined): the breath metric is a concentration of volatile organic compounds, oxygen, carbon dioxide, hydrogen, nitrogen, nitric oxide, nitric dioxide, total nitric oxides, sulphur oxides, argon, water vapor, and/or ammonia in the user's exhalation gases.
Specifically, Claim 12 recites (additional elements are in bold, abstract ideas are underlined): the breath metric is a humidity level or temperature of the user's exhalation gases.
Specifically, Claim 13 recites (additional elements are in bold, abstract ideas are underlined): the sensor is a first sensor, the respirator device further comprising a second sensor, and wherein the second sensor is a pressure sensor, a flow sensor, a temperature sensor, an audio sensor, or a position sensor.
Specifically, Claim 14 recites (additional elements are in bold, abstract ideas are underlined): the fan unit is configured to maintain a positive pressure within the breathing chamber.
Specifically, Claim 15 recites (additional elements are in bold, abstract ideas are underlined): a display element configured to display the corrected value of the measured metric.
Specifically, Claim 18 recites (additional elements are in bold, abstract ideas are underlined): wherein calculating the corrective factor includes: determining an air supply rate of atmospheric air entering the breathing chamber; determining a pressure in the breathing chamber; and based at least in part on the air supply rate and the pressure in the breathing chamber, calculating the corrective factor.
Specifically, Claim 19 recites (additional elements are in bold, abstract ideas are underlined): determining a gap area corresponding to a gap between the respiratory device and the user's face, wherein calculating the corrective factor is further based at least in part on the gap area.
Specifically, Claim 20 recites (additional elements are in bold, abstract ideas are underlined): displaying the corrected value of the breath metric to the user.
Specifically, Claim 21 recites (additional elements are in bold, abstract ideas are underlined): generating an alert if the corrected value of the breath metric exceeds a predetermined threshold.
Specifically, Claim 22 recites (additional elements are in bold, abstract ideas are underlined): generating an alert if the corrected value of the breath metric falls below a predetermined threshold.
Specifically, Claim 23 recites (additional elements are in bold, abstract ideas are underlined): the breath metric is a concentration of volatile organic compounds, oxygen, carbon dioxide, hydrogen, nitrogen, nitric oxide, nitric dioxide, total nitric oxides, sulphur oxides, argon, water vapor, and/or ammonia in the chamber gases.
Specifically, Claim 24 recites (additional elements are in bold, abstract ideas are underlined): the breath metric is a humidity level or temperature of the chamber gases.
Specifically, Claim 26 recites (additional elements are in bold, abstract ideas are underlined): the breathing chamber is fluidly coupled to an external environment via one or more gaps between the user and the device, and wherein delivering the filtered air to the breathing chamber provides a positive pressure in the breathing chamber to prevent external air from leaking into the breathing chamber through the one or more gaps.
Specifically, Claim 27 recites (additional elements are in bold, abstract ideas are underlined): the breathing chamber maintains a positive pressure throughout the steps of delivering, stopping, measuring, and restarting to prevent unfiltered external air from leaking into the breathing chamber through one or more gaps between the open respiratory device and the user's face.
Specifically, Claim 28 recites (additional elements are in bold, abstract ideas are underlined): the breath metric is a concentration of volatile organic compounds, oxygen, carbon dioxide, hydrogen, nitrogen, nitric oxide, nitric dioxide, total nitric oxides, sulphur oxides, argon, water vapor, and/or ammonia in the user's exhalation gases.
Specifically, Claim 29 recites (additional elements are in bold, abstract ideas are underlined): the breath metric is a humidity level or temperature of the user's exhalation gases.
Step 2A, Prong 2
The above-identified abstract idea in the independent Claims 1, 17 and 25 and their dependent Claims 2-15, 18-24 and 26-29 are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Claims 1-15 and 17-29), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: A respirator system, comprising: a mask component defining a breathing chamber, wherein the mask component is configured to fit at least partially over a user's face with a gap between a periphery of the mask component and the user's face; a fan unit configured to deliver external air to the breathing chamber; a sensor coupled to the mask component, wherein the sensor is configured to (i) be at least partially spaced apart from the user's mouth across the breathing chamber, A method of determining a breath metric of a user wearing an open respiratory device having a sensor spaced apart from the user's mouth by a breathing chamber, the method comprising: the chamber gases include patient exhalation gases and atmospheric air; A method of determining a breath metric of a user wearing an open respiratory device having a sensor spaced apart from the user's mouth by a breathing chamber, the method comprising: delivering atmospheric air to the breathing chamber, wherein delivering the filtered air provides a positive pressure in the breathing chamber; stopping delivery of the filtered atmospheric air to the breathing chamber during an exhalation phase of the user's breath; and after measuring the value of the breath metric, restarting delivery of the atmospheric air to the breathing chamber, the mask component includes a frame and a shield, and wherein the sensor is coupled to the frame and/or the shield, the sensor is coupled to a central portion of the frame and/or the shield positionable in front of the user's mouth, a housing having a valve moveable between an open position in which an interior of the housing is in fluid communication with the breathing chamber and a closed position in which the interior of the housing is fluidly isolated from the breathing chamber, wherein the sensor is positioned within the housing, the valve is configured to be in the open position during an exhalation phase of the user's breath, the valve is configured to be in the closed position during an inhalation phase of the user's breath, the valve is configured to automatically move between the open and closed positions based on a pressure in the breathing chamber, the fan unit is configured to maintain a positive pressure within the breathing chamber, a display element configured to display the corrected value of the measured metric, displaying the corrected value of the breath metric to the user, generating an alert if the corrected value of the breath metric exceeds a predetermined threshold, generating an alert if the corrected value of the breath metric falls below a predetermined threshold, the breathing chamber is fluidly coupled to an external environment via one or more gaps between the user and the device, and wherein delivering the filtered air to the breathing chamber provides a positive pressure in the breathing chamber to prevent external air from leaking into the breathing chamber through the one or more gaps, the breathing chamber maintains a positive pressure throughout the steps of delivering, stopping, measuring, and restarting to prevent unfiltered external air from leaking into the breathing chamber through one or more gaps between the open respiratory device and the user's face; as recited in Claims 1-15 and 17-29 do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in Claims 1-15 and 17-29 is not integrated into a practical application under 2019 PEG.
Accordingly, independent Claims 1, 17 and 25 and their dependent claims 2-15, 18-24 and 26-29 are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-15 and 17-29 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: A respirator system, comprising: a mask component defining a breathing chamber, wherein the mask component is configured to fit at least partially over a user's face with a gap between a periphery of the mask component and the user's face; a fan unit configured to deliver external air to the breathing chamber; a sensor coupled to the mask component, wherein the sensor is configured to (i) be at least partially spaced apart from the user's mouth across the breathing chamber, A method of determining a breath metric of a user wearing an open respiratory device having a sensor spaced apart from the user's mouth by a breathing chamber, the method comprising: the chamber gases include patient exhalation gases and atmospheric air; A method of determining a breath metric of a user wearing an open respiratory device having a sensor spaced apart from the user's mouth by a breathing chamber, the method comprising: delivering atmospheric air to the breathing chamber, wherein delivering the filtered air provides a positive pressure in the breathing chamber; stopping delivery of the filtered atmospheric air to the breathing chamber during an exhalation phase of the user's breath; and after measuring the value of the breath metric, restarting delivery of the atmospheric air to the breathing chamber, the mask component includes a frame and a shield, and wherein the sensor is coupled to the frame and/or the shield, the sensor is coupled to a central portion of the frame and/or the shield positionable in front of the user's mouth, a housing having a valve moveable between an open position in which an interior of the housing is in fluid communication with the breathing chamber and a closed position in which the interior of the housing is fluidly isolated from the breathing chamber, wherein the sensor is positioned within the housing, the valve is configured to be in the open position during an exhalation phase of the user's breath, the valve is configured to be in the closed position during an inhalation phase of the user's breath, the valve is configured to automatically move between the open and closed positions based on a pressure in the breathing chamber, the fan unit is configured to maintain a positive pressure within the breathing chamber, a display element configured to display the corrected value of the measured metric, displaying the corrected value of the breath metric to the user, generating an alert if the corrected value of the breath metric exceeds a predetermined threshold, generating an alert if the corrected value of the breath metric falls below a predetermined threshold, the breathing chamber is fluidly coupled to an external environment via one or more gaps between the user and the device, and wherein delivering the filtered air to the breathing chamber provides a positive pressure in the breathing chamber to prevent external air from leaking into the breathing chamber through the one or more gaps, the breathing chamber maintains a positive pressure throughout the steps of delivering, stopping, measuring, and restarting to prevent unfiltered external air from leaking into the breathing chamber through one or more gaps between the open respiratory device and the user's face; as recited in Claims 1-15 and 17-29.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in Claims 1-15 and 17-29 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-15 and 17-29 merely apply an abstract idea to a computer and do not provide a technical solution to a problem in a technical field.
Therefore, none of the Claims 1-15 and 17-29 amount to significantly more than the abstract idea itself.
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 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanaoka et al. (2016/0271429).
Regarding claim 25, in fig. 2a-2b Hanaoka discloses a method of determining a breath metric (pressure [0048-0049]) of a user wearing an open respiratory device (the device becomes open during inhalation and exhalation through inhalation and exhalation valves 2 and 3) having a sensor (Hall element 7b) spaced apart from the user's mouth by a breathing chamber (Fig. 2a), the method comprising: delivering atmospheric air to the breathing chamber (via inhalation valve 2 [0049]), wherein delivering the filtered air provides a positive pressure in the breathing chamber [0049]; stopping delivery of the filtered atmospheric air to the breathing chamber during an exhalation phase of the user's breath [0048]; measuring a value of a breath metric (pressure [0048]) associated with the user's exhalation gases during the exhalation phase of the user's breath [0048]; and after measuring the value of the breath metric, restarting delivery of the atmospheric air to the breathing chamber [0048-0049].
Regarding claim 26, Hanaoka discloses that the breathing chamber is fluidly coupled to an external environment via one or more gaps (gaps of the exhalation valve 3) between the user and the device (between the user and an outer portion of the device), and wherein delivering the filtered air to the breathing chamber provides a positive pressure in the breathing chamber (due to the increased motor fan 4 [0049]) to prevent external air from leaking into the breathing chamber through the one or more gaps (the exhalation valve stays closed during inhalation).
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 1, 11, 13-15, 17, 20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Feasey (WO 2017/065620) in view of Hok (WO 2012/064252 A1).
Regarding claim 1, in fig. 1-4 Feasey discloses a respirator system, comprising: a mask component 2 defining a breathing chamber 3, wherein the mask component is configured to fit at least partially over a user's face (Fig. 1) with a gap between a periphery of the mask component and the user's face (Page 22, lines 17-19); a fan unit 16 configured to deliver external air to the breathing chamber (Page 22, lines 30-Page 23, line 3); a sensor 15 coupled to the mask component (Page 23, lines 32-33), wherein the sensor is configured to (i) be at least partially spaced apart from the user's mouth across the breathing chamber (Page 23, lines 32-33), and (ii) measure a breath metric associated with the user's exhalation gases (Page 23, lines 32-33, pressure sensor), but is silent regarding a respiratory analysis module storing instructions that, when executed, automatically adjust a value of the measured breath metric to provide a corrected value that accounts for a dilution of the user's exhalation gases in the breathing chamber. However, Hok teaches a respiratory analysis module storing instructions that, when executed, automatically adjust a value of the measured breath metric to provide a corrected value that accounts for a dilution of the user's exhalation gases in the breathing chamber (Page 1, lines 4-11, Page 5, lines 6-32). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feasey’s system with the addition of a respiratory analysis module, as taught by Hok, for the purpose of identifying and quantifying volatile substances in a user’s exhalation breath (Page 1, lines 4-11 Hok).
Regarding claim 11, the modified Feasey discloses that the breath metric is a concentration of volatile organic compounds, oxygen, carbon dioxide (Page 1, lines 4-11 Hok), hydrogen, nitrogen, nitric oxide (Page 1, lines 4-11 Hok), nitric dioxide, total nitric oxides, sulphur oxides, argon, water vapor, and/or ammonia (Page 1, lines 4-11 Hok) in the user's exhalation gases.
Regarding claim 13, the modified Feasey discloses that the sensor is a first sensor (15 Feasey), the respirator device further comprising a second sensor (Page 12, lines 17-21, Page 19, lines 8-9, Feasey), and wherein the second sensor is a pressure sensor (Page 12, lines 17-21 Feasey), a flow sensor, a temperature sensor, an audio sensor (Page 19, lines 8-9, Feasey), or a position sensor.
Regarding claim 14, the modified Feasey discloses that the fan unit is configured to maintain a positive pressure within the breathing chamber (Page 21, lines 22-26 Feasey).
Regarding claim 15, the modified Feasey discloses an optical head up display (Page 19, lines 8-9 Feasey), but is silent regarding that a display element configured to display the corrected value of the measured metric. However, Hok teaches a display element configured to display the corrected value of the measured metric (Page 7, lines 7-10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feasey’s display with a display element configured to display the corrected value of the measured metric, as taught by Hok, for the purpose of providing important information to a user that they can readily see.
Regarding claim 17, in fig. 1-4 Feasey discloses a method of determining a breath metric (Page 23, lines 32-33, pressure sensor) of a user wearing an open respiratory device (Page 22, lines 17-19) having a sensor 15 spaced apart from the user's mouth by a breathing chamber (Fig. 2-3), the method comprising: measuring, via the sensor, a value of the breath metric in chamber gases during an exhalation phase of the user's breath (Page 23, lines 32-33, Page 16, lines 18-Page 17 line 2), wherein the chamber gases include patient exhalation gases and atmospheric air (Page 23, lines 32-33, Page 16, lines 18-Page 17 line 2); but is silent regarding calculating a corrective factor, wherein the corrective factor corresponds to a ratio between the patient exhalation gases in the chamber gases and the atmospheric air in the chamber gases; and applying the corrective factor to the measured value of the metric to determine a corrected value of the breath metric. However, Hok teaches calculating a corrective factor (Page 1, lines 4-11, Page 5, lines 6-32), wherein the corrective factor corresponds to a ratio between the patient exhalation gases in the chamber gases and the atmospheric air in the chamber gases (Page 1, lines 4-11, Page 5, lines 6-32); and applying the corrective factor to the measured value of the metric to determine a corrected value of the breath metric (Page 1, lines 4-11, Page 5, lines 6-32). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feasey’s method with the addition of calculating a corrective factor to determine a corrected value of the breath metric, as taught by Hok, for the purpose of identifying and quantifying volatile substances in a user’s exhalation breath (Page 1, lines 4-11 Hok).
Regarding claim 20, the modified Feasey discloses an optical head up display (Page 19, lines 8-9 Feasey), but is silent regarding displaying the corrected value of the breath metric to the user. However, Hok teaches displaying the corrected value of the breath metric to the user (Page 7, lines 7-10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feasey’s display with displaying the corrected value of the breath metric to the user, as taught by Hok, for the purpose of providing important information to a user that they can readily see.
Regarding claim 23, the modified Feasey discloses that the breath metric is a concentration of volatile organic compounds, oxygen, carbon dioxide (Page 1, lines 4-11 Hok), hydrogen, nitrogen, nitric oxide (Page 1, lines 4-11 Hok), nitric dioxide, total nitric oxides, sulphur oxides, argon, water vapor, and/or ammonia (Page 1, lines 4-11 Hok) in the chamber gases.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Feasey, and Hok, as applied to claim 1 above, in further view of Balke et al. (2016/0175624).
Regarding claim 5, the modified Feasey discloses that the mask component includes a shield (Page 10, lines 17-19 Feasey) and that the sensor is coupled to the shield (Page 23, lines 32-33 Feasey), but is silent regarding that the mask component includes a frame. However, in fig. 1 Balke teaches a frame 42 surrounding a shield 8. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Feasey’s shield with the addition of a frame, as taught by Balke, for the purpose of providing support to the shield.
Regarding claim 6, the modified Feasey discloses that the sensor is coupled to a central portion of the frame and/or the shield positionable in front of the user's mouth (Fig. 2-3 Feasey).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Feasey, and Hok, as applied to claim 1 above, in further view of Burgi et al. (2014/0234172).
Regarding claim 12, the modified Feasey is silent regarding that the breath metric is a humidity level or temperature of the user's exhalation gases. However, Burgi teaches that a breath metric is a humidity level or temperature of the user's exhalation gases [0014]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Feasey’s breath metric with the addition of humidity level or temperature of the chamber gases, as taught by Burgi, for the purpose of providing an additional breath metric for redundancy.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Feasey, and Hok, as applied to claim 17 above, in further view of Gurr (2017/0100610).
Regarding claim 21, the modified Feasey is silent regarding generating an alert if the corrected value of the breath metric exceeds a predetermined threshold. However, Gurr teaches generating an alert if the the breath metric exceeds a predetermined threshold [0143]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Feasey’s method with the addition of an alert if the corrected value of the breath metric exceeds a predetermined threshold, as taught by Gurr, for the purpose of providing a warning to a user of a potential sensor failure.
Regarding claim 22, the modified Feasey is silent regarding generating an alert if the corrected value of the breath metric falls below a predetermined threshold. However, Gurr teaches generating an alert if the breath metric falls below a predetermined threshold [0143]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Feasey’s method with the addition of an alert if the corrected value of the breath metric falls below a predetermined threshold, as taught by Gurr, for the purpose of providing a warning to a user of a potential sensor failure.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Feasey, and Hok, as applied to claim 17 above, in further view of Burgi et al. (2014/0234172).
Regarding claim 24, the modified Feasey is silent regarding that the breath metric is a humidity level or temperature of the chamber gases. However, Burgi teaches that a breath metric is a humidity level or temperature of the chamber gases [0014]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Feasey’s breath metric with the addition of humidity level or temperature of the chamber gases, as taught by Burgi, for the purpose of providing an additional breath metric for redundancy.
Claims 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Feasey (WO 2017/065620) in view of Hanaoka et al. (2016/0271429).
Regarding claim 25, in fig. 1-4 Feasey discloses a method of determining a breath metric (Page 23, lines 32-33, pressure sensor) of a user wearing an open respiratory device (Page 22, lines 17-19) having a sensor 15 spaced apart from the user's mouth by a breathing chamber (Fig. 2-3), the method comprising: delivering atmospheric air to the breathing chamber (Fig. 5-6 Page 22, line 22-Page 23, line 7), wherein delivering the filtered air (Page 23, lines 4-7) provides a positive pressure in the breathing chamber (Page 6, lines 8-11); and adjusts the motor based on the pressure readings during an exhalation phase of the user’s breath (Page 6, lines 8-11), but is silent regarding stopping delivery of the filtered atmospheric air to the breathing chamber during an exhalation phase of the user's breath, measuring a value of a breath metric associated with the user's exhalation gases during the exhalation phase of the user's breath; and after measuring the value of the breath metric, restarting delivery of the atmospheric air to the breathing chamber. However, Hanaoka teaches stopping delivery of the filtered atmospheric air to the breathing chamber during an exhalation phase of the user's breath [0048]; measuring a value of a breath metric (pressure [0048]) associated with the user's exhalation gases during the exhalation phase of the user's breath [0048]; and after measuring the value of the breath metric, restarting delivery of the atmospheric air to the breathing chamber [0048-0049]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feasey’s method with the addition of stopping delivery during exhalation based on the pressure readings, measuring a value of the breath metric during the exhalation phase and restarting delivery, as taught by Hanaoka, for the purpose of conserving energy.
Regarding claim 27, the modified Feasey discloses that the breathing chamber maintains a positive pressure throughout the steps of delivering, stopping, measuring, and restarting (Page 6, lines 8-11 Feasey) to prevent unfiltered external air from leaking into the breathing chamber through one or more gaps between the open respiratory device and the user's face.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Feasey and Hanaoka, as applied to claim 25 above, in further view of Palou Fustè (2018/0110946).
Regarding claim 28, the modified Feasey is silent regarding that the breath metric is a concentration of volatile organic compounds, oxygen, carbon dioxide, hydrogen, nitrogen, nitric oxide, nitric dioxide, total nitric oxides, sulphur oxides, argon, water vapor, and/or ammonia in the user's exhalation gases. However, Palou Fustè teaches that the breath metric is a concentration of volatile organic compounds, oxygen [0027], carbon dioxide [0027], hydrogen, nitrogen, nitric oxide, nitric dioxide, total nitric oxides, sulphur oxides, argon, water vapor, and/or ammonia in the user's exhalation gases. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Feasey’s breath metric with a concentration of oxygen or carbon dioxide, as taught by Palou Fustè, for the purpose of providing an alternate breath metric for detecting exhalation.
Regarding claim 29, the modified Feasey is silent regarding that the breath metric is a humidity level or temperature of the user's exhalation gases. However, Palou Fustè teaches that the breath metric is a humidity level or temperature of the user's exhalation gases [0027]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Feasey’s breath metric with a humidity level or temperature of the user's exhalation gases, as taught by Palou Fustè, for the purpose of providing an alternate breath metric for detecting exhalation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fabian et al. (2018/0078798) directed to a respiratory mask with sensors, Tang et al. (2016/0310769) directed towards a mask with sensors, Evans et al. (2017/0281051) directed towards exhalation gas measurement,
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785