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 .
Preliminary Amendment
This office action is responsive to the preliminary amendment filed on 7/11/24. As directed by the amendment: claims 1-7 have been amended, no claims have been canceled, and new claims 8-20 have been added. Thus, claims 1-20 are presently pending in the application.
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: 61 in fig. 1 and 220 in fig. 2B. 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.
Specification
The disclosure is objected to because of the following informalities:
Reference number 2020 on page 12 is suggested to be changed to 220 for consistency with figure 2B.
Reference number 224 in the last line of page 12 is suggested to be changed to 222 for consistency.
Paragraph 72, line 5 recites “predict predicting,” which appears to be a mistake.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is 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 19 recites “delivering breathing gas further comprises limiting a gas flow via a flow-limiting valve,” which is language not found in the original disclosure.
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 1-9 and 13-15 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 1 recites “the ambient,” which lacks proper antecedent basis.
Claims 7 and 15 recite “the user,” which lacks proper antecedent basis.
Claims 7 and 15 recite “the readings,” which lacks proper antecedent basis.
Claims 13-15 recites “the flow sensor,” which lacks proper antecedent basis.
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 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (2019/0083724) in view of Boulanger (2022/0241545).
Regarding claim 1, in fig. 1 Boulanger discloses an assembly for conveying breathing gas to a subject, comprising: a bag 5 configured to be attached to deliver a breathing gas to a manifold (53 and 52) and having an air inlet (structure upstream of opening to 5) and an air outlet (outlet opening of 5 closer to manifold), wherein then air inlet includes a one-way valve 55 that allows air to flow into the bag from the ambient as the bag expands [0066]; the manifold connected to the air outlet of the bag (Fig. 1); a breathing interface 6 configured to be attached to an air outlet of the manifold to receive the breathing gas from the manifold (Fig. 1); and a valve 53 and exhalation port 52 that do not allow exhaled gas to enter the bag 5, but is silent regarding a sensor configured to be secured to the air inlet on the bag such that the sensor can sense air entering the bag while the sensor remains isolated from exhaled air. However, in fig. 3 Boulanger ‘545 teaches a sensor 55 configured to be secured to the air inlet on the bag such that the sensor can sense air entering the bag while the sensor remains isolated from exhaled air ([0104] the pressure sensor is isolated from the exhaled air due to non-return valve 61). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger ‘724’s inlet (and apparatus with valve 53 and exhalation port 52 that does not allow for exhaled air to enter the bag) with the addition of a pressure sensor, as taught by Boulanger ‘545, for the purpose of providing the control unit with pressure information for safety reasons (abstract, [0070]).
Regarding claim 2, the modified Boulanger ‘724 discloses that the sensor is configured to measure any one of pressure (abstract Boulanger ‘545), volumetric flow rate, mass flow rate, and temperature.
Regarding claim 3, the modified Boulanger ‘724 discloses that the sensor is configured to be sterilized by any one of heat, chemical, or gas sterilization (the sensor is able to be sterilized by heat).
Regarding claim 5, the modified Boulanger ‘724 discloses that the sensor is configured to be non-detachably secured to the air inlet on the bag (Fig. 3 Boulanger ‘545’).
Regarding claim 6, the modified Boulanger ‘724 discloses that the sensor is configured to store or transmit information with a cable or wirelessly (Boulanger ‘545 abstract the sensor signals are transmitted either by cable or wirelessly to a control unit).
Regarding claim 7, the modified Boulanger ‘724 discloses that the sensor is configured to alert the user or provide feedback based on the readings ([0070] Boulanger ‘545).
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (2019/0083724) in view of Boulanger (2020/0268994).
Regarding claim 1, in fig. 1 Boulanger discloses an assembly for conveying breathing gas to a subject, comprising: a bag 5 configured to be attached to deliver a breathing gas to a manifold (53 and 52) and having an air inlet (structure upstream of opening to 5) and an air outlet (outlet opening of 5 closer to manifold), wherein then air inlet includes a one-way valve 55 that allows air to flow into the bag from the ambient as the bag expands [0066]; the manifold connected to the air outlet of the bag (Fig. 1); a breathing interface 6 configured to be attached to an air outlet of the manifold to receive the breathing gas from the manifold (Fig. 1); and a valve 53 and exhalation port 52 that do not allow exhaled gas to enter the bag 5, but is silent regarding a sensor configured to be secured to the air inlet on the bag such that the sensor can sense air entering the bag while the sensor remains isolated from exhaled air. However, in fig. 2 Boulanger ‘994 teaches a sensor 230 configured to be secured to the air inlet on the bag such that the sensor can sense air entering the bag while the sensor remains isolated from exhaled air ([0110] the pressure sensor is isolated from the exhaled air due to non-return valve 280 [0137]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger ‘724’s inlet (and apparatus with valve 53 and exhalation port 52 that does not allow for exhaled air to enter the bag) with the addition of a flow sensor, as taught by Boulanger ‘994, for the purpose of determining the flow delivered [0112].
Regarding claim 8, the modified Boulanger ‘724 discloses that the sensor is configured to calculate at least one of tidal volume, rate ([0111] Boulanger ‘994), or minute ventilation.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (2019/0083724) in view of Boulanger (2020/0268994), as applied to claim 1 above, in further view of Lofgren et al. (2023/0033221).
Regarding claim 4, the modified Boulanger ‘724 is silent regarding that the sensor is configured to be detachably secured to the air inlet on the bag. However, in fig. 1 Lofgren teaches a sensor 11 that is configured to be detachably secured to the air inlet on the bag [0089]. 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 Boulanger ‘724’s sensor with a detachable sensor, as taught by Lofgren, for the purpose of removing the sensor for cleaning or replacement as needed.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (2019/0083724) in view of Boulanger (2020/0268994), as applied to claim 1 above, in further view of Li et al. (2021/0046269).
Regarding claim 9, the modified Boulanger ‘724 is silent regarding a bag pressure sensor. However, in fig. 2 Boulanger ‘994 teaches a bag pressure sensor 281. 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 Boulanger ‘724’s assembly with the addition of a bag pressure sensor, as taught by Boulanger ‘994, for the purpose of detecting pressure in the bag (abstract). The modified Boulanger is silent regarding that the bag pressure sensor is configured calculate lung compliance and resistance. However, Li teaches a pressure sensor is configured calculate lung compliance and resistance [0044]. 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 Boulanger ‘724’s bag pressure sensor with calculating lung compliance and resistance, as taught by Li, for the purpose of determining a user’s lung health.
Claims 10, 13, 15-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (2019/0083724) in view of Boulanger (2020/0268994) and Lofgren et al. (2023/0033221).
Regarding claim 10, in fig. 1 Boulanger discloses a method of providing a breathing gas to a subject comprising: delivering breathing gas to the subject via a first bag 5 and a subject interface 6, the first bag having an inlet (structure upstream of opening to 5) and an air outlet (outlet opening of 5 closer to manifold) in communication with the subject interface (Fig. 1), and a valve 53 and exhalation port 52 that do not allow exhaled gas to enter the bag 5, but is silent regarding sensing, via the at least one sensor, air entering the first bag while remaining isolated from exhaled air. However, in fig. 2 Boulanger ‘994 teaches sensing, via the at least one sensor 230, air entering the first bag while remaining isolated from exhaled air ([0110] the pressure sensor is isolated from the exhaled air due to non-return valve 280 [0137]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boulanger ‘724’s method with the addition of sensing, via the at least one sensor, air entering the first bag while remaining isolated from exhaled air, as taught by Boulanger ‘994, for the purpose of determining the flow delivered [0112]. The modified Boulanger ‘724 is silent regarding detachably securing the at least one sensor to the inlet. However, in fig. 1 Lofgren teaches a sensor 11 that is configured to be detachably secured to the air inlet on the bag [0089]. 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 Boulanger ‘724’s sensor with a detachable sensor, as taught by Lofgren, for the purpose of removing the sensor for cleaning or replacement as needed.
Regarding claim 13, the modified Boulanger ‘724 discloses that the sensor is configured to measure any one of pressure, volumetric flow rate, mass flow rate ([0111] Boulanger ‘994), and temperature.
Regarding claim 15, the modified Boulanger ‘724 discloses that the flow sensor alerts the user ([0072] Boulanger ‘994), provides feedback based on the readings ([0111] Boulanger ‘994), or both.
Regarding claim 16, the modified Boulanger ‘724 discloses calculating at least one or more of tidal volume, rate ([0111] Boulanger ‘994), or minute ventilation.
Regarding claim 17, the modified Boulanger ‘724 is silent regarding a bag pressure sensor. However, in fig. 2 Boulanger ‘994 teaches a bag pressure sensor 281. 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 Boulanger ‘724’s assembly with the addition of a bag pressure sensor, as taught by Boulanger ‘994, for the purpose of detecting pressure in the bag (abstract).
Regarding claim 19, the modified Boulanger ‘724 discloses delivering breathing gas further comprises limiting a gas flow via a flow-limiting valve (safety valve 58 is a flow-limiting valve because it limits excess flow through the system by venting excess gas, Boulanger ‘724).
Regarding claim 20, the modified Boulanger ‘724 discloses the breathing gas is delivered via the outlet upon compression of the first bag (Fig. 1, Boulanger ‘724) and the first bag is refilled with breathing gas via the inlet upon release of the compression (Fig. 2, Boulanger ‘724).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (2019/0083724), Boulanger (2020/0268994) and Lofgren, as applied to claim 10 above, in further view of Minato et al. (2017/0197047).
Regarding claim 11, the modified Boulanger ‘724 is silent regarding disposing the first bag. However, Minato teaches replacing a first bag with a second bag [0065]. 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 Boulanger ‘724’s method with disposing the first bag, as taught by Minato, for the purpose of replacing the first bag as needed.
Regarding claim 12, the modified Boulanger ‘724 is silent regarding reusing the at least one sensor with a second bag. However, Minato teaches replacing a first bag with a second bag [0065]. 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 Boulanger ‘724’s method with reusing the at least one sensor with a second bag, as taught by Minato, for the purpose of replacing the first bag as needed.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (2019/0083724), Boulanger (2020/0268994) and Lofgren, as applied to claim 10 above, in further view of Inoue et al. (9,597,476).
Regarding claim 14, the modified Boulanger ‘724 is silent regarding sterilizing the flow sensor by any one or more of heat, chemical, or gas sterilization. However, Inoue teaches sterilizing the flow sensor by any one or more of heat, chemical, or gas sterilization (Col. 13, ll. 14-16). 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 Boulanger ‘724’s method with the addition of sterilizing the flow sensor by heat, as taught by Inoue, for the purpose of cleaning the sensor as needed.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (2019/0083724), Boulanger (2020/0268994) and Lofgren, as applied to claim 10 above, in further view of Li et al. (2021/0046269).
Regarding claim 9, the modified Boulanger ‘724 is silent regarding calculating lung compliance and resistance. However, Li teaches a pressure sensor that is configured calculate lung compliance and resistance [0044]. 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 Boulanger ‘724’s method with calculating lung compliance and resistance using a pressure sensor, as taught by Li, for the purpose of determining a user’s lung health.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Matthiessen et al. (2006/0260612) directed towards a compressed air respirator and Lurie et al. (11,103,672) directed towards a regulating valve.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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