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 .
Status of the Claims
The Amendment filed March 10, 2026 has been entered. Claims 1, 4-5, and 8-9 have been amended; and claims 2-3, 6-7 and 10-16 have been cancelled. Claims 1, 4-5 and 8-9 are currently pending and examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection previously set forth in the Non-Final Office Action mailed December 10, 2025.
New grounds of claim objection are necessitated by the amendment as outlined below.
All 35 U.S.C. § 102 and 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/2/2026 and 3/9/2026 has been considered by the examiner.
Claim Objection
Claim 8 is objected to because of the following informalities:
Claim 8: please amend “the detector” to – the gas detector--.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Scheffler et al. (US20170102352A1), and in view of Yung et al. (US20200324510A1) and Tang (Fan basics: air flow, static pressure and impedance, https://blog.orientalmotor.com/fan-basics-air-flow-static-pressure-impedance, Last updated on September 20, 2021). Yung is provided in IDS filed on 3/9/2026.
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Regarding claim 1, Scheffler teaches a sensor (an electrochemical device as shown in Fig.3H [para. 0135]) comprising:
a housing (see “housing” in annotated Fig.3H of Scheffler) having a first through hole including a first opening (see “first through hole” in annotated Fig.3H of Scheffler including a first opening facing the “first member”);
a first member (see “first member” in annotated Fig.3H of Scheffler), the first member facing the first opening (see annotated Fig.3H of Scheffler);
a second member (see “second member” in annotated Fig.3H of Scheffler; plenum 402 in Fig.3H [para. 0135 ] is deemed as the second member) provided between the housing and the first member (see Fig.3H), wherein the second member is provided in a direction intersecting the surface of the housing on which the first opening is present (see Fig.3H; since the second member is provided above the surface of the housing on which the first opening is present, the second member is provided in a direction intersecting the surface of the housing on which the first opening is present ), the second member has a second through hole including a second opening (test gas from the ambient environment enters plenum 402 via an inlet 402a and exits plenum 402 via an exit 402b [para. 0135]; the gas flow path from the inlet to the exit of the plenum is deemed as the second through hole including a second opening), and the second member has at least two portions facing each other (Fig.3H shows the inlet 402a and the exit 402b of the plenum 402 facing each other);
a gas detector provided in the housing (a gas sensor 410 [para. 0133] provided in the housing as shown in annotated Fig.3H of Scheffler); and
a space between the first member and the housing having the first opening (a space formed by the plenum 402 in Fig.3H [para. 0135]);
wherein the first member has a lower surface facing the housing and an upper
surface facing the lower surface (see annotated Fig.3H of Scheffler).
In the embodiment of Fig.3H, Scheffler is silent to the following limitations: (1) a first film provided between the first opening and the gas detector; (2) when the second opening and the space between the first member and the housing having the first opening are projected in a normal direction of the second opening, a projected area of the second opening is 10% or more and 90% or less of a projected area of the space; and (3) the first film has a first layer and a second layer, the first film including a first resin, a plurality of holes being provided in the first resin, the first layer including a first face, at least a part of the plurality of holes reaching the first face; and the second layer including a second resin, the second resin blocking at least a part of the plurality of holes reaching the first face.
Scheffler further teaches one or more filters 24 in fluid connection with inlet 22 either external or internal to housing 20. Housing 20 encloses a sensor 40 which is sensitive to the presence of exhaled breath. Filter 24 may, for example, be used to filter out interferent gasses (that is, gasses other than the analyte gas to which the sensor is responsive) or to filter out inhibitors or poisons [para. 0113 and Fig.1]. Fig.1 shows a filter 24 (filter 24 arranged between the inlet 22 and the barrier 30) provided between the first opening (opening of the inlet 22 facing the outer filter 24 and exhaled breath in Fig.1) and the gas detector (sensor 40).
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 gas sensor in Fig.3H of Scheffler to provide a filter arranged between the first opening and the gas detector, as taught by Scheffler in the embodiment of Fig.1, since it would allow to filter out interferent gasses (that is, gasses other than the analyte gas to which the sensor is responsive) or to filter out inhibitors or poisons [para. 0113 in Scheffler].
Yung teaches a filter (filter media comprising a nonwoven multilayer structure 100 in Fig.3 [para. 0024]) has a first layer (first layer 102 in Fig.3 [para. 0024]) and a second layer (second layer 104 in Fig.3 [para. 0024]), the first film including a first resin (the first layer 102 could be fluoropolymer [para. 0029-0030]; fluoropolymer is a type of resin), a plurality of holes being provided in the first resin ( the first nonwoven layer has a median pore size from 0.01 to 10 microns [para. 0006]), the first layer including a first face (surface 106 in Fig.3), at least a part of the plurality of holes reaching the first face (the first nonwoven layer has an average thickness of less than or equal to 30 microns and a median pore size from 0.01 to 10 microns [para. 0007], thus at least a part of the plurality of holes reaching the first face); and the second layer including a second resin (a suitable material for the second layer is a second polymer, which could be polyacrylonitrile [para. 0006, 0060], which is a type of resin), the second resin blocking at least a part of the plurality of holes reaching the first face (because the second resin of the second layer 104 is disposed on the first surface 106 as shown in Fig. 3, the second resin blocks at least a part of the plurality of holes reaching the first face).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the first film (which is a filter) in Scheffler with the filter (corresponding to the first film) having a first layer and a second layer, the first film including a first resin, a plurality of holes being provided in the first resin, the first layer including a first face, at least a part of the plurality of holes reaching the first face; and the second layer including a second resin, the second resin blocking at least a part of the plurality of holes reaching the first face, as taught by Yung, because Yung discloses its filter would be useful in a variety of applications due to their high temperature resistance, barrier, permeability properties, and processability [para.0082].
Modified Scheffler is silent to the following limitations: (2) when the second opening and the space between the first member and the housing having the first opening are projected in a normal direction of the second opening, a projected area of the second opening is 10% or more and 90% or less of a projected area of the space.
Scheffler further teaches test gas from the ambient environment is forced through plenum 402 (in the direction of the arrows of Fig.3H- that is, entering plenum 402 via an inlet 402 a and exiting plenum 402 via an exit 402 b) via pump 406 including a pump motor 406a. Pump 406 is in fluid connection with the ambient atmosphere and with plenum 402 [para. 0135].
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Tang teaches air flow in a duct (corresponding to the plenum in Scheffler) as shown in Examples 1 and 2 on page 4. In example 1, the enclosure is completely open on one end (corresponding to “second opening” in annotated Example 1 of Tang), and there is nothing that obstructs the air flow from the fan, and all air flow is expelled out of the other end. This example creates a scenario where maximum air flow would occur and we have zero static pressure. In example 2, the enclosure is enclosed except with a small exhaust hole (corresponding to “second opening” in annotated Example 2 of Tang), which hinders air flow. The constant build-up of air inside the enclosure not being able to escape increases the static pressure inside. This creates a scenario where air flow is limited by the increased static pressure. The air flow will be less than its maximum value (page 4). Thus, Tang teaches a ratio of a projected area of the second opening and a projected area of a space (in Example 1, the ratio is 100% since the enclosure is completely open at the second opening, while in Example 2 the ratio is less than 100% since the enclosure is open with a small hole at the second opening) affects the static pressure (corresponding to the static pressure in the plenum 402 in Scheffler) and air flow in the space (corresponding to the forced air flow through the plenum 402 in Scheffler).
As the static pressure and air flow in the plenum are variables that can be modified, among others, by adjusting the ratio of a projected area of the second opening and a projected area of the space, the precise ratio of a projected area of the second opening and a projected area of the space would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed “when the second opening and the space between the first member and the housing having the first opening are projected in a normal direction of the second opening, a projected area of the second opening is 10% or more and 90% or less of a projected area of the space” cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the ratio of a projected area of the second opening and a projected area of the space in modified Scheffler to obtain a projected area of the second opening being 10% or more and 90% or less of a projected area of the space in order to yield the desired air flow in the plenum to be sensed by the sensor. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 8, modified Scheffler teaches the sensor according to claim 1, and Scheffler teaches further comprising a battery (battery 408 in Fig.3H [para. 0213]); and the limitation “capable of supplying electric power to the gas detector” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Scheffler teaches the battery 408 configured to supply electric power to each sensor, as shown in Fig.3H, thus is capable of performing the functional limitations above.
Regarding claim 9, modified Scheffler teaches a sensor system (a sensor system as shown in Fig.3H of Scheffler) comprising:
the sensor according to claim 1 (modified Scheffler teaches the sensor according to claim 1); and
a processing device (Scheffler teaches a processor system 404 including, for example, one or more microprocessors [para. 0135; Fig.3H]) , wherein
the sensor includes a communication unit (Scheffler teaches sensor 410 as well as pump 406 may, for example, be in communicative connection with a control system which may, for example, include a processor system 404 [including, for example, one or more microprocessors] and/or circuitry for control thereof and data collection/processing [para. 0135]; the circuitry for control thereof and data collection is deemed as the communication unit), and
the processing device is capable of processing information based on a signal obtained from the communication unit (Scheffler teaches sensor 410 as well as pump 406 may, for example, be in communicative connection with a control system which may, for example, include a processor system 404 [including, for example, one or more microprocessors] and/or circuitry for control thereof and data collection/processing. Processor system 404 is, for example, in communicative connection with a memory system 405. System 400 may also include at least one user interface system 409 in communicative connection with processor system 404 and memory system 405 to provide information to a user [para. 0135]; Fig.4 shows a response of an example sensor [para. 0143]. Thus, the disclosed processor system is capable of processing data collected from the circuitry).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Scheffler, Yung and Tang, as applied to claim 1 above, and further in view of Bahar et al. (US20180087794A1).
Regarding claims 4-5, modified Scheffler teaches the sensor according to claim 1, and Scheffler further teaches there is a small, positive excursion of the trace, upon application of exhaled breath, which was probably a result of the changes in the local humidity of the atmosphere in fluid contact with the sensor, caused by the high humidity (near 98% RH) in exhaled breath [para. 0152].
Scheffler is silent to wherein the sensor has an electrochemical element (of claim 4), and wherein the electrochemical element is a dehumidifying element (of claim 5).
Bahar teaches an environment control system utilizes oxygen and humidity control devices that are coupled with an enclosure to independently control the oxygen concentration and the humidity level within the enclosure (abstract). Fig.6 shows an electrochemical element which is a dehumidifying element (membrane electrode assembly 30’ comprising anode 20’ and cathode 40’ and ionomer 34’ provided between anode and cathode [para. 0070, 0074]; electrochemical cell to remove moisture from the enclosure or flow stream [para. 0038]).
Given the teachings of Scheffler regarding humidity affects the sensor response, and the teachings of Bahar regarding a dehumidifying electrochemical element to control the humidity level within an enclosure, 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 sensor in modified Scheffler by providing a dehumidifying electrochemical element, as taught by Bahar, since it would allow to control the humidity level within the enclosure (corresponding to the housing of the gas sensor in modified Scheffler) [abstract in Bahar]. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results [MPEP 2143 (I)(A)].
Response to Arguments
Applicant's arguments, see Remarks Pgs. 6-10, filed 3/10/2026, with respect to the 35 U.S.C. § 102 and 35 U.S.C. § 103 rejections have been fully considered, and all prior art rejections from the previous office action have been withdrawn in view of the amendment.
Applicant’s Argument #1:
Regarding the amended claim 1, Applicant argues at pages 6-10 that the cited references fail to disclose or even suggest the subject matter of amended independent claim 1: a first film provided between the first opening and the gas detector, the first film has a first layer and a second layer, the first film including a first resin, a plurality of holes being provided in the first resin, the first layer including a first face, at least a part of the plurality of holes reaching the first face; and the second layer including a second resin, the second resin blocking at least a part of the plurality of holes reaching the first face. Furthermore, Nothing in Tang discloses or even suggests that "static pressure" is a results-effective variable in the context of Scheffler's gas sensor. Nor does Scheffler itself even mention static pressure. Thus, one of ordinary skill in the art would have no idea what the "optimum" static pressure would be for Scheffler's gas sensor, even after having been taught by Tang how to interpret a fan manufacturer's "airflow vs static pressure" graph. Therefore, one of ordinary skill in the art would have no motivation to attempt to optimize the ratio between the projected area of the second opening and the projected area of the space recited in amended independent claim 1.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection for claim 1 regarding the new features since Scheffler as modified by Yung teaches the limitations: a first film provided between the first opening and the gas detector, the first film has a first layer and a second layer, the first film including a first resin, a plurality of holes being provided in the first resin, the first layer including a first face, at least a part of the plurality of holes reaching the first face; and the second layer including a second resin, the second resin blocking at least a part of the plurality of holes reaching the first face.
Regarding the result effective variable for the projected area of the second opening, Scheffler teaches test gas from the ambient environment is forced through plenum 402 by a pump 406 [para. 0135]; Tang teaches in example 1 the enclosure is completely open on one end and creates a scenario where maximum air flow would occur and has zero static pressure, while in example 2 the enclosure is enclosed except with a small exhaust hole which hinders air flow, wherein the constant build-up of air inside the enclosure not being able to escape increases the static pressure inside, which creates a scenario where air flow is limited by the increased static pressure and the air flow will be less than its maximum value (page 4). Thus, Tang teaches a ratio of a projected area of the second opening and a projected area of a space (in Example 1, the ratio is 100% since the enclosure is completely open at the second opening, while in Example 2 the ratio is less than 100% since the enclosure is open with a small hole at the second opening) affects the static pressure in the enclosure (corresponding to the static pressure in the plenum 402 in Scheffler) and air flow in the space (corresponding to the forced air flow through the plenum 402 in Scheffler). Thus, the ratio of a projected area of the second opening and a projected area of a space affects the static pressure and air flow in the plenum 402 in Scheffler, and is a result effective variable.
Examiner suggests applicant to further amend claim 1 by reciting: a gas detector disposed on a substrate provided in the housing; a lid provided between the gas detector and the first film; and a humidity sensor provide on the substrate.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Examiner, Art Unit 1795