DETAILED ACTION
Applicant’s arguments, filed on 08/22/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 08/22/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 4-7, and 9-22 are the current claims hereby under examination.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference character “3035” in Figure 30h does not appear in the specification
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 20-21 are objected to because of the following informalities:
In claim 1, line 7, “air in the flow path” should read “the air in the flow path”
In claim 1, line 9, “air in the flow path” should read “the air in the flow path”
In claim 20, lines 1-2, “the one or more CO2 concentration values” should read “the plurality of CO2 concentration values” to be consistent with the language presented in claim 1
In claim 20, line 2, “temperatures” should read “temperature values” to be consistent with the language presented in claim 1
In claim 20, line 2, “flow rates” should read “flow rate values” to be consistent with the language presented in claim 1
In claim 21, line 6, “the one or more CO2 concentration values” should read “the plurality of CO2 concentration values” to be consistent with the language presented in claim 1
In claim 21, line 6, “temperatures” should read “temperature values” to be consistent with the language presented in claim 1
In claim 21, line 7, “flow rates” should read “flow rate values” to be consistent with the language presented in claim 1
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-7, and 9-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites the limitation “the generating the plurality of CO2 concentration values” in line 11. There is insufficient antecedent basis for this limitation in the claim. It is not clear if this limitation is referring to the detecting the plurality of CO2 concentration values. If it is, consistent terminology should be used. For purposes of examination, it is being interpreted as referring to the detecting the plurality of CO2 concentration values. Additionally, the line “the generation of values” in line 14 is also interpreted as referring to the detecting of the values.
Further, “the generating the plurality of CO2 concentration values” in line 11 and “the generation of values” in line 14 are two steps in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claims 4-7 and 9-22 are also rejected due to their dependency on claim 1.
Further regarding claim 1, the claim recites the limitation “the subject” in line 13. There is insufficient antecedent basis for this limitation in the claim. Claims 4-7 and 9-22 are also rejected due to their dependency on claim 1.
Regarding claim 4, the claim is dependent on claim 3, however claim 3 has been cancelled. A claim that depends from a canceled claim is indefinite since it is not clear what the metes and bounds of the claim are. For purposes of examination, it is being interpreted as being dependent on claim 1. Claims 6-7 are also rejected due to their dependency on claim 4.
Regarding claim 5, the claim is dependent on claim 3, however claim 3 has been cancelled. A claim that depends from a canceled claim is indefinite since it is not clear what the metes and bounds of the claim are. For purposes of examination, it is being interpreted as being dependent on claim 1.
Regarding claim 6, the claim recites the limitation “the one or more sensors” in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation is interpreted as referring to any of the carbon dioxide sensor, the temperature sensor, and/or the flow sensor from claim 1.
Further regarding claim 6, the claim recites the limitation “a plurality of the CO2 concentration values” in line 2. It is unclear if this is referring to the plurality of CO2 concentration values from claim 1, or different CO2 concentration values. If it is referring to the plurality of CO2 concentration values from claim 1, it needs to refer back to it. If it is referring to different CO2 concentration values, it needs to be distinguished from the candidate from claim 1. For purposes of examination, it is interpreted as referring to the plurality of CO2 concentration values from claim 1.
Further regarding claim 6, the claim recites the limitation “a plurality of the temperature values” in line 3. It is unclear if this is referring to the plurality of temperature values from claim 1, or different temperature values. If it is referring to the plurality of temperature values from claim 1, it needs to refer back to it. If it is referring to different temperature values, it needs to be distinguished from the candidate from claim 1. For purposes of examination, it is being interpreted as referring to the plurality of temperature values from claim 1.
Further regarding claim 6, the claim recites the limitation “a plurality of the flow rate values” in lines 3-4. It is unclear if this is referring to the plurality of flow rate values from claim 1, or different flow rate values. If it is referring to the plurality of flow rate values from claim 1, it needs to refer back to it. If it is referring to different flow rate values, it needs to be distinguished from the candidate from claim 1. For purposes of examination, it is being interpreted as referring to the plurality of flow rate values from claim 1.
Further regarding claim 6, the claim recites the limitation “a subject” in line 4. It is unclear if this is referring to the subject from claim 1, or a different subject. If it is referring to the subject from claim 1, it needs to refer back to it. If it is referring to a different subject, it needs to be distinguished from the candidate from claim 1. For purposes of examination, it is being interpreted as referring to the subject from claim 1.
Regarding claim 7, the claim recites the limitation “the one or more sensors” in line 6. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation is interpreted as referring to any of the carbon dioxide sensor, the temperature sensor, and/or the flow sensor from claim 1.
Further regarding claim 7, the claim recites the limitation “a plurality of the CO2 concentration values” in line 7. It is unclear if this is referring to the plurality of CO2 concentration values from claim 1, or different CO2 concentration values. If it is referring to the plurality of CO2 concentration values from claim 1, it needs to refer back to it. If it is referring to different CO2 concentration values, it needs to be distinguished from the candidate from claim 1. For purposes of examination, it is interpreted as referring to the plurality of CO2 concentration values from claim 1.
Further regarding claim 7, the claim recites the limitation “a plurality of the temperature values” in line 8. It is unclear if this is referring to the plurality of temperature values from claim 1, or different temperature values. If it is referring to the plurality of temperature values from claim 1, it needs to refer back to it. If it is referring to different temperature values, it needs to be distinguished from the candidate from claim 1. For purposes of examination, it is being interpreted as referring to the plurality of temperature values from claim 1.
Further regarding claim 7, the claim recites the limitation “a plurality of the flow rate values” in lines 8-9. It is unclear if this is referring to the plurality of flow rate values from claim 1, or different flow rate values. If it is referring to the plurality of flow rate values from claim 1, it needs to refer back to it. If it is referring to different flow rate values, it needs to be distinguished from the candidate from claim 1. For purposes of examination, it is being interpreted as referring to the plurality of flow rate values from claim 1.
Further regarding claim 7, the claim recites the limitation “a subject” in line 9. It is unclear if this is referring to the subject from claim 1, or a different subject. If it is referring to the subject from claim 1, it needs to refer back to it. If it is referring to a different subject, it needs to be distinguished from the candidate from claim 1. For purposes of examination, it is being interpreted as referring to the subject from claim 1.
Regarding claim 10, the claim recites the limitation “a subject” in line 17. It is unclear if this is referring to the subject from claim 1, or a different subject. If it is referring to the subject from claim 1, it needs to refer back to it. If it is referring to a different subject, it needs to be distinguished from the candidate from claim 1. For purposes of examination, it is being interpreted as referring to the subject from claim 1. Claims 11-17 are also rejected due to their dependency on claim 10.
Regarding claim 18, the claim recites the limitation “an ams® Digital Gas Sensor”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a VOC sensor and, accordingly, the identification/description is indefinite.
Regarding claim 19, the claim recites the limitation “the one or more sensors” in line 25. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation is interpreted as referring to any of the carbon dioxide sensor, the temperature sensor, and/or the flow sensor from claim 1.
Regarding claim 20, the claim recites the limitation “the one or more sensors” in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation is interpreted as referring to any of the carbon dioxide sensor, the temperature sensor, and/or the flow sensor from claim 1. Claims 21-22 are also rejected due to their dependency on claim 20.
Regarding claim 21, the claim recites the limitation “the one or more sensors” in line 7. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this limitation is interpreted as referring to any of the carbon dioxide sensor, the temperature sensor, and/or the flow sensor from claim 1. Claim 22 is also rejected due to its dependency on claim 21.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 4-5 depend from canceled claim 3, which is improper.
Claims 6-7 are rejected by virtue of their dependence from claim 4.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Stamatopoulos (US 20210282736) in further view of Jones (US 9861299).
Regarding independent claim 1, Stamatopoulos teaches a spirometer ([0040]: “FIG. 26 illustrates a spirometer with built-in lung sound analysis in accordance with an embodiment of the present invention”) comprising:
a housing comprising a first opening in fluid communication with a second opening, the first opening and the second opening defining a flow path (Fig. 26, reference character 2603);
a carbon dioxide (CO2) sensor for detecting a plurality of CO2 concentration values of air in the flow path;
a temperature sensor for detecting a plurality of temperature values of air in the flow path; and
a flow sensor for determining a plurality of flow rate values of air in the flow path ([0270]: “there can be different types of inputs into the DRCT procedure besides just a microphone (e.g., microphone 2521). For example, additional inputs can be received from a flow sensor 2522, a thermometer (to capture exhaled breath temperature) 2523, and additional respiratory gas sensors 2524.”; [0418]: “Other physiological measurements and diagnostics, including … gas analysis (02, CO2, VOCs, FeNO)”),
wherein the generation of values occurs throughout the entire breath cycle, including both inhalation and exhalation phases, for one or more complete breaths ([0098]: “embodiments of the present invention provide a method and apparatus that takes into account full breath cycles”; [0106]: “This classification can provide timestamps for each inhalation and exhalation event and for rest periods to be able to define a full breath cycle with four phases: inhalation, pause or transition, exhalation, and rest. These timestamps can be collected over several breath cycles.”).
However, Stamatopoulos is silent on how the frequency of the measurements.
Jones teaches a spirometer for personal health risk assessment. Specifically, Jones teaches wherein the generating the plurality of the CO2 concentration values, the plurality of the temperature values, and the plurality of the flow rate values at a predetermined frequency as the subject breathes through the flow path (Jones, Column 14, lines 58-60: “A standard set by the American Thoracic Society (ATS) specification for sampling is every 10 milliseconds”). Stamatopoulos and Jones are analogous arts as they are both related to spirometers used to assess a user’s health.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the frequency from Jones into the device from Stamatopoulos as Stamatopoulos is silent on the frequency in which the measurements are taken, and Jones discloses a suitable frequency in an analogous device.
Regarding claim 18, the Stamatopoulos/Jones combination teaches the spirometer of claim 1.
However, the Stamatopoulos/Jones combination is silent on the type of sensors used.
Jones teaches wherein: the carbon dioxide (CO2) sensor comprises a metal oxide gas sensor for detecting volatile organic compounds (VOCs), optionally an ams® Digital Gas Sensor; the temperature sensor comprises a band gap temperature sensor; and/or the flow sensor comprises thermal mass flow sensor element (Column 18, lines 21-23: “Such MEMS-based thermistor structures may be operable as a thermal convection or dissipation module or a thermal mass flow meter”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sensor type from Jones into the Stamatopoulos/Jones combination since the combination is silent on the type of sensors used, and Jones discloses a suitable sensor in an analogous device.
Regarding claim 20, the Stamatopoulos/Jones combination teaches the spirometer of claim 1, further comprising: - a processor for generating one or more output readings based on the one or more CO2 concentration values, temperatures and/or flow rates detected by the one or more sensors (Stamatopoulos, [0074]: “computing system 110 may also include at least one display device 124 coupled to communication infrastructure 112 via a display adapter 126. Display device 124 generally represents any type or form of device capable of visually displaying information forwarded by display adapter 126. Similarly, display adapter 126 generally represents any type or form of device configured to forward graphics, text, and other data for display on display device 124.”).
Regarding claim 21, the Stamatopoulos/Jones combination teaches the spirometer of claim 20, further comprising: - memory for storing the one or more C02 concentration values, temperatures and/or flow rates detected by the one or more sensors, optionally for storing the one or more output readings (Stamatopoulos, [0068]: “System memory 116 generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and/or other computer-readable instructions”).
Regarding claim 22, the Stamatopoulos/Jones combination teaches the spirometer of claim 21, further comprising a display for presenting the output readings to a user (Stamatopoulos, [0074]: “computing system 110 may also include at least one display device 124 coupled to communication infrastructure 112 via a display adapter 126. Display device 124 generally represents any type or form of device capable of visually displaying information forwarded by display adapter 126. Similarly, display adapter 126 generally represents any type or form of device configured to forward graphics, text, and other data for display on display device 124.”).
Claims 4-7, 9, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over the Stamatopoulos/Jones combination as applied to claim 1 above, and further in view of Ahmad (US 20170119280).
Regarding claim 4, the Stamatopoulos/Jones combination teaches the spirometer of claim 1.
However, the Stamatopoulos/Jones combination is silent on the shape of the flow path.
Ahmad discloses a flow regulation device for breath analysis. Specifically, Ahmad teaches wherein the flow path is linear ([0073]: “The cartridge may comprise a flow path. The flow path may be substantially linear.”). Stamatopoulos, Jones, and Ahmad are analogous arts as they are all devices used to measure the breath and respiratory aspects of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the linear path from Ahmad into the spirometer from the Stamatopoulos/Jones combination as the combination is silent on the shape of the path and Ahmad provides a suitable shape in an analogous device.
Regarding claim 5, the Stamatopoulos/Jones combination teaches the spirometer of claim 1.
However, the Stamatopoulos/Jones combination is silent on the shape of the flow path.
Ahmad teaches where the flow path is non-linear ([0323]: “if a particular user only required half the normal sample volume in order to complete the test, the solenoid valve could open “half-way” to lead to a semi-restrictive flow path. Similar to the embodiment illustrated in FIG. 70, this embodiment utilizes flow sensors 10125, 10130 in both flow paths 10135, 10140 to determine when the desired vented volume has been evacuated, when to switch flow paths, and when a test has been completed”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the non-linear path from Ahmad into the spirometer from the Stamatopoulos/Jones combination as the combination is silent on the shape of the path and Ahmad provides a suitable shape in an analogous device.
Regarding claim 6, the Stamatopoulos/Jones/Ahmad combination teaches the spirometer of claim 4, wherein the one or more sensors detect at least one selected from the group of: a plurality of the CO2 concentration values, a plurality of the temperature values and a plurality of the flow rate values during inhalation of air by a subject through the flow path (Stamatopoulos, [0098]: “embodiments of the present invention provide a method and apparatus that takes into account full breath cycles”; [0106]: “This classification can provide timestamps for each inhalation and exhalation event and for rest periods to be able to define a full breath cycle with four phases: inhalation, pause or transition, exhalation, and rest. These timestamps can be collected over several breath cycles.”).
Regarding claim 7, the Stamatopoulos/Jones/Ahmad combination teaches the spirometer of claim 4, wherein the one or more sensors detect one or more selected from the group of a plurality of the CO2 concentration values, a plurality of the temperature values and a plurality of the flow rate values during exhalation of air by a subject through the flow path (Stamatopoulos, [0098]: “embodiments of the present invention provide a method and apparatus that takes into account full breath cycles”; [0106]: “This classification can provide timestamps for each inhalation and exhalation event and for rest periods to be able to define a full breath cycle with four phases: inhalation, pause or transition, exhalation, and rest. These timestamps can be collected over several breath cycles.”).
Regarding claim 9, the Stamatopoulos/Jones/Ahmad combination teaches the spirometer of claim 1, wherein the first opening is configured to detachably receive a mouthpiece (Stamatopoulos, [0277]: “The spirometer may comprise … a disposable mouthpiece”.).
Regarding claim 19, the Stamatopoulos/Jones combination teaches the spirometer of claim 1.
However, the Stamatopoulos/Jones combination does not teach the spirometer having a real-time clock.
Jones teaches a real-time clock (Column 15, lines 42-46: “the processor 158 may be configured as a system-on-a-chip or application-specific integrated circuit (ASIC) that provides analog-to-digital conversion, analog filtering, I/O interfaces, one or more memories, an internal clock”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the clock from Jones into the Stamatopoulos/Jones combination as it allows the device to mark the time in which the measurements were taken, which can provide a more accurate, detailed analysis of the user’s breath and allow for a more comprehensive analysis of the user’s heath.
However, the Stamatopoulos/Jones combination does not teach wherein the one or more sensors generate a plurality of sensor readings timestamped with an output of the real-time clock.
Ahmad teaches wherein the one or more sensors generate a plurality of sensor readings timestamped with an output of the real-time clock ([0469]: “the mouthpiece comprises a clock or time-stamping mechanism. As an example, this mechanism can place a time stamp on each individual test chamber within the cartridge”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the time-stamping from Ahmad into the device from Jones as it allows the device to record when measurements have been taken, which allows for analysis over time and a more accurate collection of information.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over the Stamatopoulos/Jones/Ahmad combination as applied to claim 9 above, and further in view of JP ‘307 (JP 7390307). Citations to JP 7390307 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 10, the Stamatopoulos/Jones/Ahmad combination teaches the spirometer of claim 9.
However, the Stamatopoulos/Jones/Ahmad combination does not teach wherein the mouthpiece is shaped to form a substantially airtight seal with the lips of a subject using the spirometer.
JP ‘307 discloses a portable handheld spirometer. Specifically, JP ‘307 teaches wherein the mouthpiece is shaped to form a substantially airtight seal with lips of a subject using the spirometer ([0059]: “the diameter of the main flow passage (5) at the proximal opening (3) should be selected to fit comfortably in the mouth of the intended user and to allow the user to effectively seal the mouthpiece (2) with their lips”). Stamatopoulos, Jones, Ahmad, and JP ‘307 are analogous arts as they are all devices used to measure the breath and respiratory aspects of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the seal from JP ‘307 into the device from the Stamatopoulos/Jones/Ahmad combination as it allows the flow of air to go completely into the spirometer, ensuring the measurement is correct and takes the most accurate measurement.
Regarding claim 11, Stamatopoulos/Jones/Ahmad/JP ‘307 combination teaches the spirometer of claim 10, wherein the mouthpiece has a circular or oval cross section (Stamatopoulos, Fig. 26, mouthpiece 2603).
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over the Stamatopoulos/Jones/Ahmad/JP ‘307 combination as applied to claim 11 above, and further in view of Edwards (WO 2006076265) and Sanders (“New process makes ‘biodegradable’ plastics truly compostable”).
Regarding claim 12, the Stamatopoulos/Jones/Ahmad/JP ‘307 combination teaches the spirometer of claim 11, wherein the mouthpiece is made of a plastic material (JP ‘307, Page 23: “The (1) main components of the spirometer that contact the user's skin, namely the tubular mouthpiece (2) and the body (9), may be prepared from any biocompatible material, including biocompatible polymers. In one embodiment, biocompatible PolyJet photopolymer (MED610 ) is used. MED610 is characterized by high dimensional stability and colorless transparency. It is also possible to use polycarbonate-ISO (PC-ISO), a high-strength thermoplastic material”).
However, the Stamatopoulos/Jones/Ahmad/JP ‘307 combination does not disclose wherein the plastic material is biodegradable at a temperature above 50 degrees Celsius.
Edwards discloses methods and devices to decrease contamination. Specifically, Edwards teaches wherein the plastic material is biodegradable (Page 13, lines 9-12: “the mouthpiece (12), filter (14), connector (18), and one-way valve (16) are all disposable. Optionally, the mouthpiece (12), filter (14), connector (18), and/or one-way valve (16) are formed from biodegradable materials.”). Stamatopoulos, Jones, Ahmad, JP ‘307, and Edwards are analogous arts as they are all devices used to measure the breath and respiratory aspects of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plastic material being biodegradable from Edwards into the device from the Stamatopoulos/Jones/Ahmad/JP ‘307 combination as it allows the device to biodegrade after use, which is better for environmental conditions and provides a suitable way to dispose of the device.
However, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards combination is silent on the temperature the plastic biodegrades at.
Sanders discloses biodegradable plastics. Specifically, Sanders discloses the material biodegrading at a temperature above 50 degrees Celsius (Page 5: “the modified PLA degraded within six days at 50 degrees Celsius). Edwards and Sanders are analogous art as they are both related to biodegradable plastics.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the temperature degradation from Sanders into the device from the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards combination as the combination is silent on the temperature that the material degrades at and Sanders teaches a suitable temperature in an analogous device.
Regarding claim 13, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination teaches the spirometer of claim 12.
However, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination does not teach the spirometer further comprising a laminarization means disposed between the first opening and the second opening in order to produce a laminar airflow through the flow path.
Jones teaches the spirometer further comprising a laminarization means disposed between the first opening and the second opening in order to produce a laminar airflow through the flow path (Column 16, lines 4-8: “The thermistor 182 is also well-suited for the flow measurements described above because the flow path creates a laminar flow that removes vortexes (which may create inaccurate readings) and turbulence (turbulence may appear as high frequency noise”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the laminar flow from Jones into the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination as it allows the device to produce laminar flow, which ensures that a correct reading is being recorded for the most accurate result.
Regarding claim 14, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination teaches the spirometer of claim 12.
However, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination is silent on the locations of the sensors.
Jones teaches wherein the temperature sensor comprises a temperature sensing member in the flow path proximate to the first opening relative to the CO2 sensor or the flow sensor, optionally relative to a CO2 sensing member or a flow sensing member (Figure 2, reference character 54, “sensor segment” holds the sensors, which can be arranged in any order).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the location of the sensors from Jones into the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination as the combination is silent on the location of the sensor and Jones discloses suitable locations in an analogous device.
Regarding claim 15, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination teaches the spirometer of claim 14, wherein the predetermined frequency is at least 3, 4, 5, 6, 7, 8, 9, 10, 20, 25, 30, 40 or 50 times per second (Jones, Column 14, lines 58-60: “A standard set by the American Thoracic Society (ATS) specification for sampling is every 10 milliseconds”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination as applied to claim 15 above, and further in view of Pardey (US 20190110692).
Regarding claim 16, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination teaches the spirometer of claim 15.
However, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination does not disclose wherein the temperature sensor has a resolution of at least 0.5, 0.25, 0.1, 0.08, 0.06, 0.05 or 0.04 degrees Celsius.
Pardey discloses a method and apparatus to process a physical signal. Specifically, Pardey teaches wherein the temperature sensor has a resolution of at least 0.5, 0.25, 0.1, 0.08, 0.06, 0.05 or 0.04 degrees Celsius ([0453]: “The temperature sensor should be able to detect rises in body temperature of between 0.1 and 0.5 degC., typically around 0.3 degC., therefore a resolution of 0.01 degC”). Stamatopoulos, Jones, Ahmad, JP ‘307, Edwards, and Pardey are analogous arts as they are all devices used to measure health parameters of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the resolution of the temperature sensor from Pardey into the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders combination as the combination is silent on the resolution of the temperature sensor and Pardey provides a suitable resolution in an analogous device.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders/Pardey combination as applied to claim 16 above, and further in view of Bajtala (US 20210076980).
Regarding claim 17, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders/Pardey combination teaches the spirometer of claim 16.
However, the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders/Pardey combination is silent on the type of sensor used.
Bajtala discloses a portable spirometer. Specifically, Bajtala teaches wherein the flow sensor is a bidirectional flow sensor ([0100]: “the MEMS-based thermal fluid flow sensor (13) of the spirometer (1) is a bidirectional flow sensor (13.1), such as to allow e.g. for measurements during both inhalation and exhalation”). Stamatopoulos and Bajtala are analogous arts as they are both related to spirometers.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sensor type from Bajtala into the Stamatopoulos/Jones/Ahmad/JP ‘307/Edwards/Sanders/Pardey combination as the combination is silent on the type of sensor used, and Bajtala discloses a suitable sensor in an analogous device.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant’s arguments with respect to claims 1, 4-7, and 9-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791