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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/18/2025 has been entered.
Claims 1-8 are hereby under consideration.
Examiners Note: All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2024/0108243 A1.
Claim Rejections - 35 USC § 112(b)
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 4-7 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.
Claims 4-7 recite “relatively lower/higher storage temperature / relative humidity” but it is unclear what basis the higher/lower values are based upon. It is unclear what the values are being compared against to be considered “relatively” higher/lower. Claim 3 recites that the aging factor is based upon a temperature level and a humidity level which appears to indicate that these levels are the temperature and humidity that the sensor experiences (i.e. the measured values), but the use of the term “relatively” in claims 4-7 make it unclear if the temperature and humidity “levels” of claim 3 are meant to be baseline level to which the measured value is compared or the measured value themselves. For the purposes of this examination, the “levels” of claim 3 will be interpreted as a threshold level and the relative values of claims 4-7 will be interpreted as being compared to the threshold value (i.e. lower or higher than the threshold of claim 3. This interpretation is similarly applied to the limitation of “relatively lower/higher degradation rate” where claim 3 will be interpreted as establishing a threshold degradation rate corresponding to the threshold temperate and humidity and claims 4-7 will be interpreted as corresponding to changes in the degradation rate relative to the threshold degradation rate.
Claim Rejections - 35 USC § 112(a)
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 1-8 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “receive a measurement from the sensor corresponding to a biological parameter sensed in the sample breath” which indicates that the sensor may include any type of sensor for sensing any type of biological parameter from the breath. Such a scope is not fully supported by Applicant’s specification. In particular, Applicant’s specification is drawn towards the use of electrochemical sensors and the measurement of carbon monoxide (CO) as evidenced by paragraphs 0012-0013, 0045, 0053, 0055, 0058 and 0062. Paragraph 0051 does recite that molecular hydrogen (H2) sensors may also be present but the measurement of molecular hydrogen is used to compensate for interference with the CO measurement and no recitation of compensating the molecular hydrogen measurement itself appears to be made. Paragraph 0051 further recites” “sensors may also include any number of different sensor types including chemical gas sensors, electrochemical gas sensors, etc. for detecting agents such as carbon monoxide” which provides support for additional sensor types but indicates that such sensors measure carbon monoxide. The language “such as” is not considered sufficient to support the sensor being used for other types of biological parameter measurement.
Claim 1 recites “apply a re-calibration to adjust for a stabilization speed of the measurement using initial parameters obtained from an initial calibration and where the initial parameters are adjusted based on a transient response component collected during the sample breath” in particular, the limitation “where the initial parameters are adjusted based on a transient response component collected during the sample breath” indicates that the transient response component used in the re-calibration to adjust for stabilization speed is collected during the sample breath. The specification does recite that the stabilization speed made be calibrated using a measured transient response in paragraphs 0014, 0078, and 0088. However, the mechanism for performing such a compensation is described in paragraphs 0015-0018 and 0057-0063 which indicates that the shape of the concentration versus time curve must be known in order to calibrate the transient response. This may be done by feeding a known concentration of CO in a step pattern as illustrated in Fig. 3A, or by using the return to ambient concentration when the user stops exhaling. The specification states that the air in the mouth and trachea likely have a lower CO concentration than the air in the alveoli of the lungs. Thus the shape of the concentration versus time curve during the sample breath is unknown since it is unknown what the CO concentration in the mouth and trachea is relative to the air in the alveoli. The specification indicates that the drop from the steady-state response to ambient levels of CO from diffusion or forcefully removing the breath sample from the device, by shaking or having the user breath in through the device, is what is used to calibrate the transient response since the shape of the CO concentration is known (the concentration does from steady state levels back to ambient levels). Thus it would seem that the specification does not support adjusting the initial calibration using the transient response component recorded during the sample breath, but if rather directed towards adjusting the initial calibration using the transient response component recorded after the sample breath, or after the user stops exhaling. This is further reflected in Figs. 5 and 6 step 84. Furthermore, the term “sample breath” does not appear to be explicitly defined to include the time after the user stops exhaling and even if such a definition was applied then the claim still encompasses the use of the initial transient response illustrated in Fig. 2 reference 54 to perform the calibration which is not seemingly supported.
Claims 2-8 depend from claim 1 and do not rectify the above presented rejections of claim 1 and are thus rejected by virtue of their dependance.
Prior Art
US Patent Application Publication Number US 2017/0119279 A1 hereinafter Ahmad teaches a breath capture device for determining the concentration of acetone in a breath sample from a user. In some embodiments, the device includes a controller programmed to use stored data to control flow of a breath sample into an analysis chamber as the user exhales into a port. In other embodiments, the device includes a switch responsive to an action by the user that is operable between a first orientation in which breath entering the port preferentially travels through a second flow path and a second orientation in which breath entering the port preferentially travels through a first flow path. In still other embodiments, the device includes a flow regulator both responsive to user action and operable from a first position in which breath entering a port preferentially travels through a second flow path to a second position in which breath entering the port preferentially travels through a first flow path (Abstract). Ahmad teaches that the device includes a vessel of cavity coupled to the mouthpiece to receive a fluid breath sample. The vessel further includes a sensor disposed within the vessel for interacting with the reactive components of the breath sample (Paragraph 0216). The sensor may be a variety of types of sensors and may monitor a variety of different analytes (Paragraph 0217 and Table 1). The sensor is in communication with a processor which receives the output of the sensor (Paragraph 0220).
US Patent Application Publication Number US 2019/0339224 A1 hereinafter Bhavaraju teaches systems and methods that address the need to frequently calibrate analyte sensors. The systems and methods provide a preconnected analyte sensor system that physically combines an analyte sensor to measurement electronics during the manufacturing phase of the sensor and in some cases in subsequent life phases of the sensor, so as to allow an improved recognition of sensor environment over time to improve subsequent calibration of the sensor (Abstract). Bhavaraju teaches a system and method for compensating for sensor age and storage conditions by adjusting their calibration model. The adjustments may be made to the initial or final sensor sensitivity, background signal, and/or the equilibrium rate. The calibration model may be determined for individual sensors or a sensor lot. The calibration adjustments may use additional input information such as information that has been previously obtained over time for large numbers of sensors and patients which experienced similar conditions (Paragraph 0036). The calibration model may also include a time component that uses data obtained by examining the sensitivity profile and background signal profile of the sensor over time since the factory calibrated initial sensitivity. The sensor calibration model may be compensated based on the difference between the factory calibration value and the rate of change during a sensitivity transition period. Typical break-in curves can be obtained for sensors from this data as well as changes to the curves arising from changes induced by sterilization, temperature, humidity and/or storage time. These break-in curves may be used to compensate the sensor calibration model for deviations from the factory calibration (Paragraph 0037). The system may also include passive monitoring methods of environmental conditions during storage. The environmental monitoring includes temperature and/or humidity monitoring in the packaging. The system may prevent a sensor from being used if the monitor determines that the temperature or humidity have, at some point, for some duration, exceeded acceptable limits (Paragraphs 0034-0035).
US Patent Application Publication Number US 2016/0033340 A1 hereinafter Todd teaches a method for calibrating a sensor of a monitoring apparatus for monitoring an analyte concentration in a body fluid sample of a patient in which a temperature-dependent drift model is derived for the sensor. An apparatus for monitoring an analyte concentration in a body fluid sample of a patient including such a sensor and a signal processor programmed to calibrate the sensor in accordance with this method (Abstract). Todd teaches that calibration coefficients have a limited validity as various effects on a sensor such as aging and fouling will cause the calibration coefficients to drift over time. These coefficients may be periodically recalibrated but such a solution is not ideal for constant patient monitoring (Paragraph 0044). Todd further teaches that the sensor output is temperature dependent and model to derive the calibration at a given temperature is generated using several temperature measurements (Paragraphs 0041-0043). The calibration curve thus accounts for sensor drift as a function of temperature and may extend the recalibration frequency (Paragraph 0051)
US Patent Application Publication Number US 2017/0284999 A1 hereinafter Maric teaches improved and highly advantageous metal oxide based sensor assemblies configured to sense low concentration of specific gases, and related methods of use. The present disclosure provides improved physical forms of metal oxide films. The highly advantageous films/materials can be utilized in sensor assemblies to detect simple chemical components of the breath that correlate with human health conditions (e.g., the presence of acetone in diabetic patients). These films/materials demonstrate improved thermal stability under the sensor's operating conditions, as well as improved sensitivity to low concentration of the analyte, selectivity and quick responsiveness (Abstract). Maric relates to sensing analytes in exhaled breath (Paragraph 0017), and states that working temperature is an important factor for sensor performance since the mechanism of sensing is influenced by kinetics and varying temperatures can increase or decrease activation barriers (Paragraph 0165). Which can impact the sensor’s response time (Paragraphs 0149- Figs. 17A and 17B).
None of Ahmad, Bhavaraju, Todd, and/or Maric either alone or in combination teach or reasonably suggest the apparatus comprising “wherein the processor is further configured to apply a re-calibration to adjust for a stabilization speed of the measurement using initial parameters obtained from an initial calibration and where the initial parameters are adjusted based on a transient response component collected during the sample breath” in combination with the other claimed elements. In particular, none of the prior art of record teaches or reasonably suggests the calibration of a transient response using parameters related to a sample breath.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998): In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection !.B.1. Fora reply toa non-final Office action, see 37 CFR1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying- online/eterminal-disclaimer.
Claims 1-3 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 11957451 B2, hereinafter Jameson. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued patent includes all limitations required by the present claims.
In particular, claims 1-2 of Jameson anticipate claim 1 of the present application
Claim 4 of Jameson anticipates claim 2 of the present application
Claim 3 of Jameson anticipates claim 3 of the present application
Claims 2-3 of Jameson anticipate claim 8 of the present application
Response to Arguments
Applicant's arguments filed 09/18/2025 have been fully considered and are found to be persuasive. In particular, the amended language is not taught by the prior art of record.
New grounds of rejection have been set forth.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791