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 .
Election/Restrictions
Applicant’s election without traverse of Species D: Subspecies 3 in the reply filed on 02/02/2026 is acknowledged.
Claims 2, 3, 6, 12-15, 17, and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/02/2026.
Currently claims 1, 4, 5, 7-11, 16, 19-23, and 25 are under examination.
Claim Objections
Claim 25 is objected to because of the following informalities:
Claim 25 should be claim 24. For the purposes of examination claim 25 is interpreted as claim 24.
Appropriate correction is required.
Claim Interpretation
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:
“breath delivery mechanism” in claims 1, 11, and 19. It is understood to be either an on/off switch or button, pressor sensors/ detector that triggers a blower and its flow, or a manual knob on the blower that could be the on/off mechanism of the blower for manual actuation.
“portable ventilation system” in claims 16, 19-23 and 25. It is understood that portable means a blower is attachable to an outer surface of a mask.
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.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4, 5, 8, 11, 16, 19, 23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fogarty (US 20190070374 A1).
Regarding claim 1, Fogarty discloses a ventilation mask, comprising:
a mask body having an outer surface and an inner surface configured for engagement with a face of a subject, and an inlet opening to receive air from a blower assembly (Figure 1 below; where ‘28’ is an inlet opening that receives air from the blower assembly ‘40’, and Fogarty [0031] lines 1-4; the mask ‘20’ has an inner surface configured for engagement with a face and an outer surface too);
and a breath delivery mechanism, that when manually operated, is configured to activate the blower assembly to deliver a breath to the subject (Fogarty [0049]; where there is a button than can be selectively engaged (manually operated) to activate the blower’s initiation of delivery of ventilation support (breath) to a subject).
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Figure 1: Annotated Figure 5 of Fogarty.
Regarding claim 4, Fogarty further discloses the ventilation mask in claim 1, wherein the blower assembly is attachable to the outer surface of the mask body defining a portable ventilation system (Fogarty [0032]; where the blowing assembly ‘40’ can be positioned in fluid communication with the inlet opening ‘28’ (on the outer surface) of the mask body ‘22’, also as seen in Figure 3 and Figure 4 (further depicting a portable ventilation system); where the blowing assembly ‘40’ can be inside the ventilator system ‘10’ and is attached to the mask ‘20’).
Regarding claim 5, Fogarty further discloses the ventilation mask in claim 4, wherein the blower assembly is in direct fluid communication with the inlet opening of the mask body (Fogarty [0032]; where the blowing assembly ‘40’ can be positioned in fluid communication with the inlet opening ‘28’ (on the outer surface) of the mask body ‘22’, also as seen in Figure 3 and Figure 4 (further depicting a portable ventilation system); where the blowing assembly ‘40’ can be inside the ventilator system ‘10’ and is attached to the mask ‘20’).
Regarding claim 8, Fogarty further discloses the ventilation mask in claim 1, further comprising a jaw support assembly coupled to the mask body (Fogarty [0048] lines 1-2; where there can be a chin support assembly (Figure 1 above ‘50’) coupled to the mask body – the chin is part of the lower jaw);
wherein the jaw support assembly maintains a jaw posture of the subject during engagement of the inner surface of the mask body to the face of the subject (Fogarty [0048] lines 2-3; where the chin support assembly can be configured to maintain a desired posture of the subject and is coupled to the mask body ‘20’).
Regarding claim 11, Fogarty further discloses a portable ventilation system (Fogarty Figure 4; where the blower assembly is housed in the ventilation system and can be attached to the outer surface of the mask via the inlet), comprising:
a ventilation mask, wherein the ventilation mask includes a mask body having an outer surface and an inner surface configured for engagement with a face of a subject, wherein the mask body defines an inlet opening configured to receive an airflow, a blower assembly positioned in fluid communication with the inlet opening of the mask body to direct the airflow to the inlet opening of the mask body (Figure 1 above; where ‘28’ is an inlet opening that receives air from the blower assembly ‘40’, and Fogarty [0031] lines 1-4; the mask ‘20’ has an inner surface configured for engagement with a face and an outer surface too and [0032]; where the blowing assembly ‘40’ can be positioned in fluid communication with the inlet opening ‘28’ (on the outer surface) of the mask body ‘22’);
and a breath delivery mechanism, that when manually operated, activates the blower assembly and delivers a breath to the subject by increasing a pressure within the ventilation mask (Fogarty [0049]; where there is a button (breath delivery mechanism) than can be selectively engaged (manually operated) to activate the blower’s initiation of delivery of ventilation support (breath) to a subject and Fogarty [0032] lines 8-10; where the blowing assembly can be controlled based on the measured pressure in the mask, detected by a pressure sensor).
Regarding claim 16, Fogarty further discloses the portable ventilation system in claim 11, wherein the blower assembly is attached to the outer surface of the mask body and the blower assembly is in direct fluid communication with the inlet opening of the mask body (Fogarty [0032]; where the blowing assembly ‘40’ can be positioned in fluid communication with the inlet opening ‘28’ (on the outer surface) of the mask body ‘22’, also as seen in Figure 3 and Figure 4 (further depicting a portable ventilation system); where the blowing assembly ‘40’ can be inside the ventilator system ‘10’ and is attached to the mask ‘20’).
Regarding claim 19, Fogarty further discloses the portable ventilation system in claim 11, further comprising a battery assembly to power the blower assembly in response to the breath delivery mechanism being operated (Fogarty [0094]; where the blower ‘40’ can be powered by a battery (assembly) to deliver breath (air delivery) and [0049]; where there is a button (breath delivery mechanism) than can be selectively engaged (manually operated) to activate the blower’s initiation of delivery of ventilation support (breath) to a subject).
Regarding claim 23, Fogarty further discloses the portable ventilation system in claim 11, further comprising a jaw support assembly configured to be placed under a subject's chin to maintain jaw posture during engagement of the inner surface of the mask body to the face of the subject (Fogarty [0048] lines 1-2; where there can be a chin support assembly (Figure 1 above ‘50’) coupled to the mask body – the chin is part of the lower jaw and [0048] lines 2-3; where the chin support assembly can be configured to maintain a desired posture of the subject and is coupled to the mask body ‘20’).
Regarding claim 25, Fogarty further discloses the portable ventilation system in claim 11, wherein the mask body further comprises at least one leak opening extending between the inner surface and the outer surface of the mask body to control pressure within the ventilation mask (Figure 1 above; ‘30’ is the plurality of leak openings in the mask body ‘20’, Fogarty [0006]; the leak openings ‘30’ extend between the inner and outer surface of the mask body ‘20’, and [0007]; where the air/oxygen exits the mask body ‘20’ through the leak openings ‘30’ – this balances the pressure inside the mask body ‘20’ relative to ambient air to help control pressure within the ventilation mask).
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 7 is rejected under 35 U.S.C. 103 as being obvious over Fogarty (US 20190070374 A1) in view of Lalonde (US 20120304985 A1).
Regarding claim 7, Fogarty discloses the ventilation mask in claim 1.
Fogarty fails to disclose wherein the mask body defines an air filter assembly that is in fluid communication with the inlet opening of the mask body.
Lalonde discloses a CPAP system with a mask wherein,
the mask body defines an air filter assembly that is in fluid communication with the inlet opening of the mask body (Lalonde Figure 4; where ‘52’ is a flow generator cap that houses the intake filter ‘86’ (air filter assembly) [0057] and intakes air through the intake holes ‘80’ (inlet opening) of the mask body ‘44’ of Figure 3 – thereby having fluid communication).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ventilation mask of Fogarty to include an air filter assembly with the inlet opening of the mask body as taught by Lalonde, since, it allows the air filter to be occasionally replaced more easily (Lalonde [0057]).
Claim 9 is rejected under 35 U.S.C. 103 as being obvious over Fogarty (US 20190070374 A1) in view of Beard (US 20130060157 A1).
Regarding claim 9, Fogarty discloses the ventilation mask in claim 1.
Fogarty fails to disclose a capnography port in a wall of the mask body.
Beard discloses a facemask assembly comprising:
a capnography port in a wall of the mask body (Beard Figure 4 ‘15’ is a sampling port on the mask ‘28’ where carbon dioxide is sampled (capnography) on the wall of the mask body [0040]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ventilation device of Fogarty to include a capnography port as taught by Beard, since, a capnography port allows the clinician to ensure a patient is breathing adequately when there is a surgery or during a trauma by allowing them to sample a respiratory gas for analysis (Beard [0022]).
Claim 10 is rejected under 35 U.S.C. 103 as being obvious over Fogarty (US 20190070374 A1) in view of Lindblom (US 20080053449 A1).
Regarding claim 10, Fogarty discloses the ventilation mask in claim 1.
Fogarty fails to disclose an endoscope port in a wall of the mask body.
Lindblom discloses a respiratory mask comprising:
an endoscope port in a wall of the mask body (Lindblom Figure 1; ‘20’ is an endoscope port in the wall of the mask body ‘10’).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ventilation mask of Fogarty to include an endoscope as taught by Lindblom, since, an endoscope port is helpful for accepting an endoscope which allows the clinician to better examine upper gastrointestinal (GI) tracts and pulmonary regions (Lindblom [0010]).
Claim 20 is rejected under 35 U.S.C. 103 as being obvious over Fogarty (US 20190070374 A1) in view of Shelly (US 20150296550 A1).
Regarding claim 20, Fogarty discloses the portable ventilation system in claim 19.
Fogarty discloses a ventilation mask comprising:
a battery (Fogarty [0094]; where the blower ‘40’ can be powered by a battery to deliver breath (air delivery)).
Fogarty is silent to the battery including an assembly with an induction coil and rectifier for inductive charging of the battery assembly.
Shelly discloses a pressure support system for respiratory therapy wherein:
a battery assembly includes an induction coil and rectifier for inductive charging of the battery assembly (Shelly [0034]; where the wireless peripheral device of Figure 4 ‘32’ has an inductor/coil ‘35’ in the form of a spiral coil (induction coil), and [0045]; where ‘68’ of Figure 7 is a rectifying circuit (rectifier) and ‘35’ inductor/coil for the charging power circuit ‘64’ (battery assembly) with a battery ‘72’ (energy storage device such as a battery as stated)).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the portable ventilation system of Fogarty to include a rectifier and an induction coil as part of the battery assembly as taught by Shelly, since, a rectifier and an induction coil help to ensure proper signals are generated toward the battery to help manage battery power (Shelly [0046]).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being obvious over Fogarty (US 20190070374 A1) in view of Wang (CN 109876319 A).
Regarding claim 21, Fogarty discloses the portable ventilation system in claim 11.
Fogarty is silent to a handle and a handle having a mask interface to connect with the inlet opening of the mask body, and being shaped to allow a user to retain the ventilation mask on a patient using a single hand, while simultaneously engaging the breath delivery mechanism with the single hand.
Wang discloses a portable ventilation mask comprising:
a handle having a mask interface to connect with the inlet opening of the mask body, and shaped to allow a user to retain the ventilation mask on a patient using a single hand, while simultaneously engaging the breath delivery mechanism with the single hand (Figure 2 below; where there is a handle that connects to the inlet opening of the mask body through an interface (mask interface) – the handle is shaped to allow the user to do actions with a single hand and the control button ‘25’ is connected to a blower allowing the user to engage in breath delivery with one hand).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the portable ventilation mask of Fogarty to include a handle and a button to engage with the breath delivery mechanism all with one hand as taught by Wang, since, the handle allows the user to hold the mask by hand, making it more portable and more compact, therefore it is easier to use and the button allows the user to hold the mask with the handle and simultaneously deliver air to a user, which in turn makes the device more portable and easier to use also (Wang Summary of the invention [04], [08]).
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Figure 2: Annotated Figure 2 of Wang.
Regarding claim 22, Fogarty further discloses the portable ventilation system of claim 21.
Fogarty fails to disclose a handle with a frustoconical shape that extends away from a main body of the blower assembly.
Wang discloses a portable ventilation mask wherein,
the handle has a frustoconical shape which extends away from a main body of the blower assembly (Figure 2 above; where the handle has a frustoconical shape at the end, ‘3’ is the blower assembly, and the frustoconical shape extends away from the blower assembly ‘3’).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ventilation device of Fogarty to include a handle that has a frustoconical shape as taught by Wang, since, this shape allows the device to better conform to the user’s operating habits (Wang Detailed Ways [04]).
Furthermore, there is no evidence of record that establishes that changing the shape of the entire handle of the ventilation mask to be frustoconical would result in a functional difference of the modified Fogarty device. Further, a person having ordinary skill in the art, being faced with modifying the portable ventilation mask of Fogarty, would have a reasonable expectation of success in making such a modification and it appears the system would function as intended being given the claimed shape of the handle to the portable ventilation mask. Lastly, Applicant has not disclosed that the claimed shape solves any stated problem, that such a shape of the handle produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify portable ventilation mask of Fogarty to have the exact shape of the claimed portable ventilation mask as an obvious matter of design choice within the skill of the art.
Conclusion
The following prior art were considered but not used on a 35 U.S.C. § 102 or 103 rejection:
Darby (US 20150157818 A1): respiratory mask device with a blower assembly.
Gosweiler (US 20050103343 A1): portable blower and respiratory system with an inlet on the mask and a detachable tube for the blower.
Palou (US 20180110946 A1): respiratory mask with frustoconical shape on annular projections.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is 571-272-3835. The examiner can normally be reached Monday-Friday 8am-5pm, EO Friday 8am-4pm EST.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785