DETAILED ACTION
This office action is in response to the Response to Election/Restriction dated 05/18/2026. Thus, claims 1 – 21 are pending in the application.
Election/Restrictions
Claims 12 – 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/18/2026.
Applicant’s election without traverse of Group I in the reply filed on 05/18/2026 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/120119, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application provides support to “heating wires”, but does not provide support to the claimed heating coils and wire mesh. As such, the instant application has been afforded an effective filing date of 11/30/2021.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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.
Claim 1 and dependents therein 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. There is insufficient antecedent basis for the limitation “ambient air” in claim 1, line 3. It is unclear if the ambient air is intended to refer to the earlier recited “inlet air”, or another source of air. Additionally, it is unclear how ambient air would possess a dynamic property, as required by claim 3. As such, examiner recommends replacing “inlet air” with “ambient inlet air” in claim 1, line 2, and then furthermore replacing “ambient air” with “inlet air” where recited elsewhere in the claims, as appropriate. For example, claims 2 and 3 additionally recite the phrase “ambient air”.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a heating element” in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 6 is objected to because of the following informalities: the claims recite that the humidifier cartridge comprises “a heating element”. The claims should be further amended to distinguish this heating element from the earlier device heating element recited in claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 8, 9, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sweeney (US 20110253136).
1. Sweeney teaches a device for treating and/or preventing hypothermia in a patient (102, Fig. 1; para [0038], 'airway treatment device 102'; per [0052] and [0061], the device would be fully capable of treating and/or preventing hypothermia by delivering heat to the patient), characterized by: an opening for inlet air (unlabeled air inlet to the left of 133, Fig. 1; para [0038], 'The blower 104 will typically include an air inlet'): a temperature sensor configured to measure a temperature of the ambient air (113, Fig. 1; para [0061], 'sensors may be located to measure the treatment gas at various locations in the delivery tube such as near the blower (e.g., before or after)'); at least one battery (para [0069], 'a DC battery sufficient to permit at least a use for a single sleep session without connection to an AC power outlet); a furnace section (portion of 106 between 112 and the right end of 135, Fig. 1; para [0052], 'delivery tube 106') comprising a heating element configured to heat air in the furnace section (135, Fig. 1: para [0052]; ‘in the case of a heated delivery tube, insulation material may be provided on the tube to prevent the heat from the tube from bothering the patient or otherwise being transferred to the skin of the patient'; the heater may additionally include 111, which heats the ‘breathable gas via convection’); wherein the heating element comprises heating wires, heating coils, or wire mesh (heaters 111 and 135 are illustrated as coiled as per Fig. 1) a valve configured to mix inlet air with heated furnace air to form output air at an output air temperature based at least in part on data from the temperature sensor (299, Fig. 2, para [0054]; the active flow gate 299 ‘may be controlled to activate to a position that allows the splitting or mixing of the flow between the two paths. For example, based on the desired humidity and/or temperature settings measured by one set of sensors in a combined tube, the controller may adjust the flow gate to mix variable amounts of gas of two distinct flow paths at two different humidity and/or temperature settings, which may be separately controlled by readings from two additional and different sets of sensors'; the path flow is directed by the blower, which pulls ambient air from its air inlet as previously discussed); and an output for providing the output air to a patient (108, Fig. 1; para [0042], 'nasal cannula 108').
2. Sweeney discloses the device according to claim 1, further comprising a humidity sensor configured to measure a humidity of the ambient air (117, Fig. 1; para [0052], ‘humidifity sensors (117, 121, 134)’; see also [0054]).
8. Sweeney discloses the device according to claim 1, further comprising one or more output air sensors configured to measure a temperature and/or a humidity of the output air (see [0054]; ‘desired humidity and/or temperature settings measured by one set of sensors in a combined tube’ which provides the output air).
9. Sweeney discloses the device according to claim 1, further comprising another temperature sensor that is configured to measure a temperature of the air in the furnace section (see [0054]; ‘two distinct flow paths… [each with] two additional and different sets of sensors’, where the two flow paths are from the ambient inlet air and the furnace sections).
11. Sweeney discloses the device according to claim 1, wherein the opening for inlet air is connectable to: a manual compression bag and mask for providing ambient air, or a pressurized air source for providing pressurized inlet air (see [0052], the blower inlet may be supplied with bottled gas).
Claim Rejections - 35 USC § 103
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Protecsom Amerique Du Nord (US 20200352474, hereinafter “Protescsom”).
3. Sweeney teaches the device according to claim 1, but fails to specify further characterized by a pitot system comprising a static pressure sensor and a dynamic pressure sensor configured to measure the static and dynamic pressures of the ambient air. Sweeney does teach a pressure sensor configured to measure the pressure of the ambient air (114, Fig. 1; para [0060], 'pressure sensors 114'). Protecsom teaches a flow measuring device for an inhalation apparatus (10, Fig. 10; para [0143], 'flow measuring apparatus 10') comprising a pitot system comprising a static pressure sensor and a dynamic pressure sensor configured to measure the static and dynamic pressures of an inlet air flow (Fig. 9; para [0124], the set of Pitot tubes being configured for traversing entirely a lumen which defines the section of the inhalation apparatus; and the first and second Pitot tube 21, 22 being respectively fluidly connected to a differential pressure sensor 324, for measuring a difference between a stagnation pressure and a static pressure within the flow (F) measuring apparatus'; para [0063], 'the dynamic pressure is equal to the difference between the stagnation pressure and the static pressure'; para [0143]). Accordingly, it would have been obvious to a person having ordinary skill in the art to have used the pitot system as taught by Protecsom in place of the pressure sensor as taught by Sweeney in order to obtain better pressure readings for the ambient air flow for blower control thereof.
Claim(s) 4, 5, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Doyle (US 7617824).
4. Sweeney teaches the device according to claim 1, but fails to specify further characterized by a valve or sliding plunger configured to seal an exhalation port during inhalation of the patient. Sweeney does teach that a sealed interface may be used, thus requiring an exhalation port for venting of patient exhalations and maintenance of pressure, see [0042], as well as administering of conventional CPAP therapy, see [0106 0107]. Doyle teaches a ventilator (30, Fig. 1; col 5, In 39-40, 'ventilation system 30') further characterized by a dual limb patient circuit for outputting air to a patient (70, Fig. 1; col 7, In 22-23, 'dual-limb patient circuit 70'), the circuit comprising a valve or sliding plunger configured to seal an exhalation port during inhalation of the patient (50, Fig. 1; col 7, In 29-30, 'exhaust valve 50'; col 7, In 44, 'During inspiration, valves 50 and 58 are closed'). Accordingly, it would have been obvious to a person having ordinary skill in the art to have used the valved exhalation port as taught by Doyle with the device as taught by Sweeney to provide a means to control the pressure in a patient's lungs during exhalation, while ensuring against leakage of air during inhalation.
5. Sweeney as modified by Doyle (see claim 4 above) discloses the device according to claim 1, further comprising an exhalation port having at least one switch or flap that is openable and closeable based at least in part on data from a dynamic pressure sensor (col 6, In 49-51, first exhaust valve 50 operates under the control of controller 46 to control the patient's expiration and positive end expiratory pressure (PEEP)'; examiner notes that that valve may be considered a switch as currently claimed).
7. Sweeney as modified by Doyle (see claim 4 above) discloses the device according to claim 1, further comprising an output section having an output valve and/or output spring configured to maintain a positive end-expiatory pressure in lungs of the patient (col 6, In 49-51, first exhaust valve 50 operates under the control of controller 46 to control the patient's expiration and positive end expiratory pressure (PEEP)', wherein the output section corresponds to the PEEP valve exhalation port).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Usry (US 4588425) in view of Goff (US 20170216552).
6. Sweeney discloses the device according to claim 1, further comprising a humidifier cartridge (112) comprising a heating element or wire configured to prevent the liquid from freezing (111). However, Sweeney does not explicitly disclose that the humidifier is removably attachable. Nonetheless, Usry discloses a humidifier cartridge that is removably attachable, e.g. to tubing connected thereto, see Fig. 1b, 18, c. 2: 14 – 16. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the humidifier of Sweeney according to the removable connection of Usry for the benefit of appropriately servicing and/or refilling the humidifier, or otherwise replacing device parts such as tubing.
However, Sweeney does not disclose that humidifier comprises an ultrasonic transducer configured to spray mist into the furnace section. Nonetheless, Goff discloses a humidifier comprising an ultrasonic transducer configured to spray mist into the furnace section (see [0079 – 0080], Fig. 15, wherein above the above chamber and tubing in Fig. 15 corresponds to the furnace section, since it receives heated air). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the humidifier of Sweeney according to the ultrasonic transducer of Goff for the benefit of relatively efficient power use compared to other humidification technologies.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Kenyon (US 20090194101).
10. Sweeney discloses the device according to claim 1, wherein the at least one battery is characterized by a first battery configured to provide power to one or more components of the device (para [0069], 'a DC battery sufficient to permit at least a use for a single sleep session without connection to an AC power outlet'), and a second power source is configured to charge the first battery (see [0069]). However, Sweeney does not disclose a second battery configured to charge the first battery, wherein the first battery comprises two or more cells connected in series. Nonetheless, Kenyon disclose a respiratory powered device wherein at least one battery is characterized by a first rechargeable battery configured to provide power to one or more components of the device (see [0045]), and a second battery (see [0045], “plurality of batteries” are used within the system), wherein the first battery comprises two or more cells connected in series (each battery comprises 32 cells, see [0045]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the first battery and power source of Sweeney according to the multiple battery system of Kenyon for the benefit of portable use of the device, as well as sustained use including docking/charging in the event of a power outage.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5890490 – valve switch between humidified and non-humidified air in housing
US 20150165146 – humidifier cartridge integrated into housing
US 8015971 – valve switch between humidified and non-humidified air in housing
US 20160184547 – rotatable valve controlling humidity
US 8905023 – housing connected to humidifier cartridge
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/ Primary Examiner, Art Unit 3799
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