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 with traverse of Group I: Subspecies 1, in the reply filed on 02/27/2026 is acknowledged.
Through updated searching, and upon further reconsideration of the current claims, the Examiner has reconsidered in view of Applicant’s arguments and based on reasonableness, the Restriction requirement to be withdrawn.
Claim Objection
Claims 40, 50, 61, 64, 65-68, 70-71 and 73 are objected to because of the following informalities:
Claim 40 should be rewritten to avoid positive recitations of the patient and method like steps in a device claim. See suggestions accordingly below:
“A patient interface comprising:
a plenum chamber configured to be pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure by a flow of air at the therapeutic pressure for breathing by a patient, the plenum chamber further comprising two plenum chamber connectors, each of the plenum chamber connectors configured to be positionable on a corresponding lateral side of the plenum chamber and configured to receive the flow of air at the therapeutic pressure;
a seal-forming structure connected to the plenum chamber, the seal-forming structure configured to be constructed and arranged to seal with a region of the patient's face that at least partly surrounds an entrance to the patient's airways, the seal-forming structure configured to have a hole therein to deliver the flow of air at the therapeutic pressure to at least the patient's nares during use, the seal-forming structure configured to be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use;
a positioning and stabilising structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure further comprising two conduits, each of the conduits being configured to be positioned on a corresponding lateral side of the patient's head in use and being configured to connect to a corresponding one of the plenum chamber connectors;
a vent assembly connected to the plenum chamber and configured to have a plurality of vent holes that are configured to allow a continuous flow of gases exhaled by the patient from within the plenum chamber to ambient throughout the patient's respiratory cycle, the vent holes are sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; and
a heat and moisture exchanger (HMX) assembly connected to the vent assembly, the HMX assembly including an HMX frame and a material positioned on the HMX frame, the material is configured to adsorb water vapour from gases exhaled by the patient and desorb water vapour into the flow of air at the therapeutic pressure, the material is configured to be supported by the HMX frame within the plenum chamber such that at least a portion of the flow of air at the therapeutic pressure entering the plenum chamber from the plenum chamber connectors passes through the material before entering the patient's airways, and the HMX frame is configured to be constructed from a flexible material;
wherein the patient interface is configured to leave the patient's mouth uncovered, or the seal-forming structure is configured to seal around the patient's nose and mouth and the patient interface is configured to allow the patient to breath from ambient in the absence of the flow of air at the therapeutic pressure.”
Claim 50: the recitation “vent holes”, should read ---vent body holes---, to avoid antecedent basis, and any other corresponding recitation of “vent holes”.
Claim 61: the recitation “each of the slots being configured”, should read ---each of the slots are configured---, to avoid reciting method like steps in a device claim.
Claim 64: the recitation “the material is positioned within the plenum chamber such that gas exhaled by the patient”, should read ---the material is configured to be positioned within the plenum chamber such that gas exhaled by the patient---, in order to avoid positively reciting the patient.
Claims 65-67, 71: similarly, to claim 64, the recitation “the material”, should be followed by ---configured to be positioned---.
Claim 68: the recitation “and wherein a peripheral portion of the material is positioned on the HMX frame such that gases flowing”, should read ---and wherein a peripheral portion of the material is configured to be positioned on the HMX frame such that gases flowing---, to avoid reciting method like steps in a device claim.
Claim 70: the recitation “the material is attached”, should read ---the material is configured to be attached--- to avoid reciting method like language in a device claim pertaining to the overmoulding.
Claim 73: the recitation “to allow at least a portion of the gas exhaled by the patient”, should read ---configured to allow at least a portion of the gas exhaled by the patient---, to avoid positively reciting the patient.
Appropriate correction is required.
Claim Interpretation
Regarding claim 40, with the recitation “plenum chamber connectors”, it is interpreted that the plenum chamber connectors are the tube connectors ‘3202’ of Figure 51.
Additionally, the recitation “seal-forming structure” and any other recitation of such is being interpreted as a cushion member that seals around a portion of the patient’s face.
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.
Claim 61 is rejected under 35 U.S.C. 112(b), 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.
Regarding claim 61, the recitation of the limitation "the HMX struts" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections – 35 U.S.C. § 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
Claims 40-50, 55, 59-60, 62-68, 71 and 75-77 are rejected under 35 U.S.C. 103 as obvious over Brambilla (US 20140276177 A1) in view of Bordewick (WO 2007117716 A2) and further in view of Harrington (WO 2015013761 A1).
Regarding claim 40, Regarding claim 40, Brambilla discloses a patient interface (Brambilla Figure 11; patient interface is the structure on the patient’s head);
comprising: a plenum chamber pressurisable to a therapeutic pressure (Brambilla [0045]; where the fluid chamber ‘24’ (plenum chamber, fluid chamber intakes air) is maintained at a prescribed therapeutic level throughout);
the plenum chamber further comprising two plenum chamber connectors, each of the plenum chamber connectors being positioned on a corresponding lateral side of the plenum chamber and configured to receive the flow of air at the therapeutic pressure (Brambilla [0040]; ‘80’,’82’ of Figure 1 are the first and second connectors that receive the flow);
a seal-forming structure connected to the plenum chamber, the seal-forming structure being constructed and arranged to seal with a region of the patient's face that at least partly surrounds an entrance to the patient's airways the seal-forming structure having a hole therein to deliver the flow of air at the therapeutic pressure to at least the patient's nares during use (Brambilla Figures 3/4; ‘26’ are the nasal pillows that deliver air to patient’s nares (thereby having a hole), ‘16’ is the cushion that seals the face (seal forming structure));
the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use (Brambilla [0045]; where the fluid chamber ‘24’ (plenum chamber, fluid chamber intakes air) is maintained at a prescribed therapeutic level throughout, and the cushion seal ‘16’ is against the patient’s face with the fluid chamber inside in Figures 3 and 4);
a positioning and stabilising structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's head (Figure 1 below; positioning and stabilizing structure, and Brambilla Figures 3,4; where the cushion ‘16’ holds the structure in an effective position on the patient’s head);
the positioning and stabilising structure further comprising two conduits, each of the conduits being configured to be positioned on a corresponding lateral side of the patient's head in use and being configured to connect to a corresponding one of the plenum chamber connectors (Figure 1 below; conduit 1/2, and the fluid chamber is inside ‘110’ of the Figure 11 of Brambilla, Brambilla Figure 1; where the plenum chamber connectors are ‘80’ and ‘82’);
a vent assembly connected to the plenum chamber (Brambilla Figure 3,4; exhalation valve ‘14’ and diaphragm ‘48’, “fluid is able to freely pass through”);
and having a plurality of vent holes configured to allow a continuous flow of gases exhaled by the patient from within the plenum chamber to ambient throughout the patient's respiratory cycle (Brambilla Figure 1; ‘60’ are vent ports (holes), [0054]; vented to ambient via the vent ports during exhalation phase of respiratory cycle);
the vent holes being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (Brambilla [0098]; the structural/ functional features of the vent assembly (exhalation valve, diaphragm), ensure the exhaled gas goes to ambient, along with the plenum chamber (fluid chamber), maintains the therapeutic pressure (as mentioned above));
and a heat and moisture exchanger (HMX) assembly connected to the vent assembly (Brambilla Figure 2; ‘12’: HME (heat-moisture exchanger) device, connects to vent assembly (‘14’+’48’));
the HMX assembly including an HMX frame and a material positioned on the HMX frame (Brambilla Figure 2; ‘44’+’46’ is a frame that supports the HMX material, material = layers ‘92’, ‘94’, ‘96’, [0057]; may be fabricated for a single layer);
the material being configured to adsorb water vapour from gases exhaled by the patient and desorb water vapour into the flow of air at the therapeutic pressure (Brambilla [0060]; HME device retains heat and moisture and is transferred into the air passing to the nostrils of the patient – thereby passing the plenum chamber (fluid chamber) with the flow of the therapeutic pressure);
the material being supported by the HMX frame within the plenum chamber such that at least a portion of the flow of air at the therapeutic pressure entering the plenum chamber from the plenum chamber connectors passes through the material before entering the patient's airways (Brambilla Figure 2; where the HME device ‘12’ is between the frame and the plenum chamber (fluid chamber ’24’) inside outer surface ‘22’, HMX frame = ’44,46’: frame portion that supports the HMX material, through orientation, air passes through HME material first then to the plenum chamber, then to the patient’s nostrils);
wherein the patient interface is configured to leave the patient's mouth uncovered or the seal-forming structure is configured to seal around the patient's nose and mouth and the patient interface is configured to allow the patient to breath from ambient in the absence of the flow of air at the therapeutic pressure (Brambilla Figure 5; patient’s mouth is uncovered because the device only has means for the nostrils here).
Brambilla fails to disclose a therapeutic pressure of at least 4cmH2O.
Bordewick discloses the respiratory therapy device,
with a therapeutic pressure of at least 4 cmH20 above ambient air pressure by a flow of air at the therapeutic pressure for breathing by a patient (Bordewick pg. 2 line 15).
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 patient interface of Brambilla to include the therapeutic pressure 4cm H2O as taught by Bordewick, since, respiratory therapies typically pressurize the airways of a user to a pressure in the range of 4-20cm H2O (Bordewick pg. 2 line 15).
Modified Bordewick is silent to the HMX frame being made of a flexible material.
Harrington discloses a HMX for a patient interface comprising:
the HMX frame being made of a flexible material (Harrington [0348]; where the HMX frame (flexible supporting membrane ‘7050’ of Figure 14E + ‘7003’ HME frame) supports the HME material ‘7000’ within the space of the patient interface ‘3000’, where the flexible supporting membrane that frames the HMX material is made of a flexible material - all connected to the vent assembly ‘3410’ of Figure 9A).
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 patient interface of modified Brambilla by replacing the rigid HMX frame with a flexible HMX frame that is connected to the vent assembly as taught by Harrington, since, a flexible HMX frame allows for the frame to be easily manipulated and movable with the HMX material within the patient interface (Harrington [0348]).
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Figure 1: Annotated Figure 11 of Brambilla.
Regarding claim 41, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the material further comprises foam or paper (Brambilla [0008]; currently known HMX devices contain a housing of a material with a layer of flexible, fibrous, gas-permeable material, the fibrous material can be made of foam or paper or other suitable materials that are untreated/treated with hygroscopic material).
In the event that it is not clear that Brambilla discloses foam or paper, it would have been obvious for one of ordinary skill to use foam or paper for the HMX material because this material has the capacity to retain moisture and heat from the air that is exhaled from the patient’s lungs, and then transfer the captured moisture and heat to the inhaled air when the patient is inhaling with the assistance of the flow generator (Brambilla [0008]), which would further help to protect the patient from dry or sore nasal, mouth or oral passageways.
Regarding claim 42, modified Brambilla in view of Harrington further discloses the patient interface of claim 40.
Modified Brambilla fails to disclose wherein the material comprises salt applied to the surface of the material.
Harrington discloses wherein:
the material further comprises a salt applied to a surface of the material (Harrington [052]; “Heat and moisture exchangers are generally made up of foam, paper, or a substance capable of acting as a condensation and absorption surface. The material may carry hygroscopic salts to improve the water-retaining capacity. Suitable salts include calcium chloride” – the salt is part of or carried on the active surface of the HMX material).
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 patient interface of modified Brambilla to include salt on the surface of the HMX material as taught by Harrington, since salt with the HMX material helps to improve the water retaining capacity (Harrington [052]).
Regarding claim 43, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the material is removable from the HMX frame (Brambilla Figure 2; where the material ’92,94,96’ = ‘12’ is removable from the HMX frame ’44,46’, and as modified Harrington also provides the HMX material being removable from the HMX frame: Harrington Figure 10E; HMX frame portion ‘7003’ without material and Figure 11A; with the HMX material).
Regarding claim 44, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the HMX assembly is removable from within the plenum chamber (Brambilla [0055]; HMX material ‘12’ = ’92,94,96’ is removable from ‘16’ which has the plenum chamber ‘24’ inside via Brambilla Figure 3).
Regarding claim 45, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the vent assembly is removably connected to the plenum chamber (Brambilla [0063]; vent assembly ‘14+48’ may be detached from the fluid chamber ‘24’ (plenum chamber), and as shown in Figure 2).
Regarding claim 46, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the vent assembly and the HMX assembly are removable together from the plenum chamber (Brambilla Figure 1 and [0055,0063]; ‘12’ includes the layers of material ’92,94,96’ that can be permanently attached to vent assembly ‘14+49’ as shown in Figure 3, Figure 2; where they are outside of the plenum chamber ‘24’ (within ‘16’) – thereby allowing them to be removed together from the plenum chamber).
Regarding claim 47, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the HMX assembly is removable from the vent assembly (Brambilla Figure 2; where the HMX assembly ‘12’ that contains the material ’92,94,96’ is removable from the vent assembly ‘14+48’ (‘48’ is between ’44,46’)).
Regarding claim 48, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the vent assembly comprises a vent body and a vent cap attached to the vent body (Brambilla Figure 2; where ‘44’ is the vent body, and ‘46’ is the vent cap that is attached to the vent body ‘44’ making the vent assembly).
Regarding claim 49, modified Brambilla in view of Harrington further discloses the patient interface of claim 48, wherein the vent holes are formed between the vent body and the vent cap (Brambilla Figure 1; ‘60’ is vent holes that are formed between the vent body ‘44’ and the vent cap ‘46’).
Regarding claim 50, modified Brambilla in view of Harrington further discloses the patient interface of claim 49.
Modified Brambilla is silent to the vent body holes being configured to allow the continuous flow of gases to pass through.
Harrington discloses a patient interface wherein:
the vent body further comprises vent body holes configured to allow the continuous flow of gases exhaled by the patient to pass through the vent body and then to atmosphere through the vent holes (Harrington [0178]; vent ‘3400’ allows for the washout of CO2, [0179]; where the vent ‘3400’ has a plurality of holes, [070]; where the vent is configured for regulating the washout of expiratory gas at a constant flow rate, [039]; the vent allows a flow of gas from the interior of the patient interface to the exterior of the patient interface, to ambient, [0454]; the vent is the structure that allows the flow from the interior of the mask to ambient air to allow for the washout of exhaled gases).
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 patient interface of modified Brambilla to have the vent body holes configured to allow the continuous flow of gases exhaled by the patient to pass through the vent body and thein the vent holes, to then to the atmosphere as taught by Harrington, since it allows for regulation of the washout of expiratory gas (Harrington [070]), and since it helps to prevent the rebreathing of exhaled CO2, by clearing it out at a steady and controlled rate.
Regarding claim 55, modified Brambilla in view of Harrington further discloses the patient interface of claim 48, wherein the HMX frame includes an HMX rim connected to the vent assembly (Harrington Figure 9B; ‘7003’ is the HMX frame + flexible supporting member ‘7050’ of Figure 14E, Figure 10E; ‘7005’ is the HMX rim connected to the vent assembly ‘3410’).
Regarding claim 59, modified Brambilla in view of Harrington further discloses the patient interface of claim 55, wherein the HMX rim is joined directly to the HMX frame (Harrington Figure 10A; ‘7003’ HMX frame + flexible supporting membrane ‘7050’ of Figure 14E is joined directly with the HMX rim ‘7005’).
Regarding claim 60, modified Brambilla in view of Harrington further discloses the patient interface of claim 55, wherein the vent body includes an attachment structure configured to receive the HMX rim to attach the HMX frame to the vent body (Harrington Figure 9B; where ‘3450,7004’ is an attachment structure to attach the HMX rim ‘7005’ of Figure 10A, included in ‘7000’, to the vent body ‘3410’).
Regarding claim 62, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the plenum chamber includes a receiving hole configured to receive the vent assembly and through which the HMX assembly is inserted inside of the plenum chamber (Brambilla Figure 2; ‘28’ is a receiving hole configured to receive the vent assembly ’14,48’ and HMX assembly ‘12’ to be inserted inside the plenum chamber ‘24’ of Figure 3).
Regarding claim 63, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the flexible material is silicone rubber or thermoplastic elastomer (Harrington [0348]; where the flexible material of the HMX frame ‘7050’ (portion that frames the HMX material), is made of silicone, [0440]; silicone or silicone elastomer, a synthetic rubber).
Regarding claim 64, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the material is positioned within the plenum chamber such that the flow of air at the therapeutic pressure must pass through the material before entering the patient's airways (Brambilla Figures 3-4; air flow is shown, where air flows through material ‘12’ which includes layers ’92,94,96’ before entering airway, [0045]; air is maintained at therapeutic level in the plenum chamber ‘24’).
Regarding claim 65, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the material is positioned within the plenum chamber such that gas exhaled by the patient must pass through the material before exiting to ambient through the vent holes (Brambilla Figure 4; where the material ‘12’ with layers ’92,94,96’ is positioned within the plenum chamber ‘24’ such that the gas exhaled by the patient must pass through the material ‘12’ before exiting to ambient through the vent holes, ‘601’ of Figure 1, [0054]; vented to ambient of exhalation).
Regarding claim 66, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the material is positioned within the plenum chamber such that at least a portion of the flow of air at the therapeutic pressure bypasses the material before entering the patient's airways (Brambilla Figures 3-4; air flow is shown, where air flows through material ‘12’ which includes layers ’92,94,96’ before entering airway, [0045]; air is maintained at therapeutic level in the plenum chamber ‘24’).
Regarding claim 67, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the material is positioned within the plenum chamber such that at least a portion of the gas exhaled by the patient bypasses the material before exiting to ambient through the vent holes (Brambilla Figure 4; where the material ‘12’ with layers ’92,94,96’ is positioned within the plenum chamber ‘24’ such that the gas exhaled by the patient must pass through the material ‘12’ before exiting to ambient through the vent holes, ‘601’ of Figure 1, [0054]; vented to ambient of exhalation).
Regarding claim 68, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the HMX frame forms an HMX frame hole, and wherein a peripheral portion of the material is positioned on the HMX frame such that gases flowing through the material pass through the HMX frame hole (Harrington Figure 10B; where the HMX frame ‘7003’ + flexible supporting membrane ‘7050’ forms a frame hole ‘7006’ such that a peripheral portion of the HMX material is positioned on the frame so that gases flowing through the material pass through the frame hole ‘7006’).
Regarding claim 71, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the material further comprises a posterior surface that faces the patient's face in use, the posterior surface being positively curved to avoid contact with the patient's face during use (Brambilla Figures 3-4; material ‘12’ is curved with a posterior surface positively curving and avoiding the patient’s face during use).
Regarding claim 75, modified Brambilla in view of Harrington further discloses the patient interface of claim 40, wherein the seal-forming structure is configured to leave the patient's mouth uncovered and the seal-forming structure further comprises nasal pillows or a nasal cradle (Brambilla Figure 11, [0009]; where the seal forming structure ‘16’ leaves mouth uncovered, Figure 2; ‘26’ nasal pillows).
Regarding claim 76, modified Brambilla in view of Harrington further discloses the patient interface of claim 40.
Modified Brambilla discloses wherein:
the seal-forming structure is configured to seal around the patient's nose and the seal-forming structure further comprises a nasal hole or two nasal holes that are configured to pneumatically communicate with the patient's nares in use (Brambilla Figure 11; seal forming structure ‘16’ leaves mouth uncovered and seals around the patient’s nose, Figures 3-4; where ‘26’ is the nasal pillows that comprise the nasal holes that are configured to pneumatically communicate with the patient’s nares in use).
Harrington discloses wherein:
the seal-forming structure is configured to seal around the patient’s nose and mouth and a mouth hole that is configured to pneumatically communicate with the patient's mouth in use (Harrington [026]; where the nose and the mouth are covered by the seal forming structure, and Figure 14A; where ‘3100’ the seal forming structure for the patient’s nose and mouth, edges form the shape of opening (mouth hole) that is configured to pneumatically communicate with the patient’s mouth in use).
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 patient interface of modified Brambilla to include the seal forming structure sealing also around the mouth and providing air through a hole to the mouth as taught by Harrington, since it would allow for the lower lip region of the face to also be sealed and provided with pneumatic communication (Harrington [026]).
Regarding claim 77, modified Brambilla in view of Harrington further discloses a respiratory pressure therapy (RPT) system comprising: the patient interface of claim 40; a respiratory pressure therapy (RPT) device configured to generate the flow of air at the therapeutic pressure; and an air circuit configured to connect the RPT device and the patient interface to direct the flow of air at the therapeutic pressure from the RPT device to the patient interface, wherein the RPT system does not include a humidifier (see claim 40 above for patient interface, Brambilla Figure 11 ‘120’ is an RPT configured to generate the flow of air at the therapeutic pressure, ‘102’ is an air circuit configured to connect to ‘120’ RPT device and the patient interface to direct the flow of air at a therapeutic pressure from the RPT device ‘120’ to the patient interface, [0012]; HMX device can fully replace a humidifier – thereby not needing or including a humidifier).
Claims 51-52 and 61 are rejected under 35 U.S.C. 103 as obvious over Brambilla (US 20140276177 A1) in view of Bordewick (WO 2007117716 A2) further in view of Harrington (WO 2015013761 A1) and even further in view of Dantanarayana (WO 2018126295 A1).
Regarding claim 51, modified Brambilla in view of Harrington further discloses the patient interface of claim 48, comprising the vent body and the vent cap (Brambilla Figure 2; where ‘44’ is the vent body, and ‘46’ is the vent cap that is attached to the vent body ‘44’).
Modified Brambilla in view of Harrington fails to disclose a vent diffuser material.
Dantanarayana discloses a vent assembly wherein:
wherein the vent assembly includes a vent diffuser material positioned between the vent body and the vent cap (Dantanarayana [0342-0343]; where there is a diffuser with the vent assembly and Figure 33F; where the diffuser material ‘9146’ is between the vent body ‘9300’ and the vent cap ‘9330’).
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 patient interface of modified Brambilla in view of Harrington to include a diffuser material with the vent structure as taught by Dantanarayana between the vent cap and vent body, since, it acts as a sound absorbing material to reduce some of the noise caused by the air flowing through the vent assembly (Dantanarayana [0342-0343]).
Regarding claim 52, modified Brambilla in view of Harrington, further in view of Dantanarayana further discloses the patient interface of claim 51, wherein the vent body includes a spacer to space the vent diffuser material away from the vent holes and against the vent cap (Dantanarayana [0448]; where there are vent spacers ‘9149’ – Figure 34A - spaced radially about the vent diffuser cover ‘9330’ (vent cap), to hold the diffuser ‘9146’ against the vent diffuser cover ‘9330’ and radially away from the vent holes ‘9340’).
Regarding claim 61, modified Brambilla in view of Harrington further discloses the patient interface of claim 60.
Modified Brambilla in view of Harrington fails to disclose slots formed through the attachment structure that receives an HMX strut.
Dantanarayana discloses an HMX and vent assembly wherein:
one or more slots are formed through the attachment structure, each of the slots being configured to receive a corresponding one of the HMX struts (Dantanarayana [0425]; where the HMX housing ‘9180’ (HMX frame), has a pair of slots ‘9181’ that correspond to the arms ‘9171’ of the HMX struts ‘9170’, thereby making an attachment structure because the slots are received by the struts, Figures 12A, 13A-B).
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 patient interface of modified Brambilla in view of Harrington to include slots in the attachment structure to receive the HMX struts as taught by Dantanarayana, since, a slot would allow the HMX material to be secured between the HMX struts such that it does not rotate relative to the HMX frame (Dantanarayana [0425]), thus providing more support and stability to retain the HMX material in place.
Claims 53 and 54 are rejected under 35 U.S.C. 103 as obvious over Brambilla (US 20140276177 A1) in view of Bordewick (WO 2007117716 A2) further in view of Harrington (WO 2015013761 A1) further in view of Dantanarayana (WO 2018126295 A1) and even further in view of Amarasinghe (US 20180250486 A1).
Regarding claim 53, modified Brambilla in view of Harrington, further in view of Dantanarayana further discloses the patient interface of claim 52,
wherein one of the plenum chamber and the vent body includes one or more orientation indication protrusions, wherein the other of the mask frame and the vent body includes one or more orientation indication recesses configured to receive corresponding ones of the orientation indication protrusions when the vent body is attached to the mask frame (Harrington [0334]; the vent assembly ‘3410’ (includes the body) has attachment members ‘3450’ (orientation indication protrusions) to releasably join the vent assembly to the mask frame ‘3250’ (which is connected to the plenum chamber ‘3200’) with a snap fit (e.g. a protrusion and a recess)).
Modified Brambilla in view of Harrington, further in view of Dantanarayana fails to disclose orientation indication protrusions and recesses on the vent body or the plenum chamber causing a direct connection of the two parts.
Amarasinghe discloses the patient interface wherein:
one of the plenum chamber and the vent body includes one or more orientation indication protrusions, wherein the other of the plenum chamber and the vent body includes one or more orientation indication recesses configured to receive corresponding ones of the orientation indication protrusions when the vent body is attached to the plenum chamber (Amarasinghe Figure 6; where ‘6650’ is an orientation indication protrusion on the vent body ‘6700+6610’ that provides the vent body to be removably disengage-able from the plenum chamber ‘6500’ inside ‘6110’, Figure 8; ‘6500’ plenum chamber – space inside of mask, [0314]; where the connection is mechanical interlock, e.g. snap-fit connection (protrusion and recess)).
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 patient interface of modified Brambilla in view of Harrington, further in view of Dantanarayana to include a protrusion and recess relationship as orientation indications for the vent body and the plenum chamber to disengagably connectable as taught by Amarasinghe since, it allows for the two portions to be connected by mechanical interlock and be removable/ disengagable from each other (Amarasinghe [0314]).
Regarding claim 54, modified Brambilla in view of Harrington, further in view of Dantanarayana, and even further in view of Amarasinghe further discloses the patient interface of claim 53, wherein one of the plenum chamber and the vent body includes a connection lip, wherein the other of the plenum chamber and the vent body includes a connection channel configured to receive the connection lip to removably attach the vent body to the plenum chamber (Brambilla Figure 4; ‘74’ connection lip on vent body ‘44’, space between the vent body ‘44’ and the connection lip ‘74’ is the connection channel configured to removably attach the vent body ‘44’ to the plenum chamber ‘24’, Figure 2; where the plenum chamber ‘24’ within ‘16’ is removed from the lip ‘74’ with the vent body ‘44’).
Claims 56-58 are rejected under 35 U.S.C. 103 as obvious over Brambilla (US 20140276177 A1) in view of Bordewick (WO 2007117716 A2) further in view of Harrington (WO 2015013761 A1) and even further in view of Fahl (WO 2019121894 A1).
Regarding claim 56, modified Brambilla in view of Harrington further discloses the patient interface of claim 55.
Modified Brambilla in view of Harrington fails to disclose HMX struts joined to the HMX rim of the HMX frame.
Fahl discloses a heat and moisture exchanger wherein:
the HMX frame includes one or more HMX struts joined to the HMX rim (Fahl Figure 1; ‘66’ is the HMX struts that are straight, are joined to the HMX rim ‘64’ of the HMX frame and ‘44’ is the HMX struts that are bent).
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 patient interface of modified Brambilla in view of Harrington to include HMX struts joined to the HMX rim as taught by Fahl since, it holds the HMX rim of the HMX frame away from other structures (Fahl [0050]), which allows for the frame to form ventilation openings for air to flow into and out of the HMX material.
Regarding claim 57, modified Brambilla in view of Harrington further in view of Fahl further discloses the patient interface of claim 56, wherein each of the HMX struts is straight (Fahl Figure 1; where all of the HMX struts ‘66’ are straight).
Regarding claim 58, modified Brambilla in view of Harrington further in view of Fahl further discloses the patient interface of one claim 56.
Fahl discloses the HMX struts that are straight (Fahl Figure 1; ‘66’ is the HMX struts that are straight, are joined to the HMX rim ‘64’ of the HMX frame and ‘44’ is the HMX struts that are bent). Additionally, Fahl discloses HMX struts that are bent (Fahl Figure 1; ‘44’ are HMX struts are bent, [0050]; with the purpose of exerting a restoring force on the valve structure), however they are not attached to the HMX rim.
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 patient interface of modified Brambilla in view of Harrington in view of Fahl by utilizing bent HMX struts as taught by Fahl joined to the HMX rim, because it would provide a restoring force to the underlying structure (Fahl [0050]), thereby improving the structural integrity and stability of the HMX frame.
Claims 69-70 are rejected under 35 U.S.C. 103 as obvious over Brambilla (US 20140276177 A1) in view of Bordewick (WO 2007117716 A2) further in view of Harrington (WO 2015013761 A1) and even further in view of Bagby (US 20040011359 A1).
Regarding claim 69, modified Brambilla in view of Harrington further discloses the patient interface of claim 40.
Modified Brambilla in view of Harrington fails to disclose the material being permanently attached to the HMX frame.
Bagby discloses a HMX material wherein:
the material is permanently attached to the HMX frame (Bagby [0009]; where the heat exchange elements (including material ‘102’ – [0033]) can be permanently attached to the HMX frame using glue (adhesive)).
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 patient interface of modified Brambilla in view of Harrington to permanently attach the material to the HMX frame via an adhesive as taught by Bagby, since it allows the elements to be more permanently secured to each other (Bagby [0009]).
Regarding claim 70, modified Brambilla in view of Harrington further discloses the patient interface of claim 40.
Modified Brambilla in view of Harrington fails to disclose the material being permanently attached to the HMX frame.
Bagby discloses a HMX material wherein:
the material is attached to the HMX frame by one or more of the following: an adhesive, overmoulding the HMX frame onto the material, and retainers to hold the material against the HMX frame (Bagby [0009]; where the heat exchange elements (including material ‘102’ – [0033]) can be permanently attached to the HMX frame using glue (adhesive)).
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 patient interface of modified Brambilla in view of Harrington to attach the material to the HMX frame via an adhesive as taught by Bagby, since it allows the elements to be more permanently secured to each other (Bagby [0009]).
Claims 72 and 74 are rejected under 35 U.S.C. 103 as obvious over Brambilla (US 20140276177 A1) in view of Bordewick (WO 2007117716 A2) further in view of Harrington (WO 2015013761 A1) and even further in view of Dhuper (WO 2013112470 A1).
Regarding claim 72, modified Brambilla in view of Harrington further discloses the patient interface of claim 40.
Modified Brambilla in view of Harrington fails to disclose a sealing lip configured to seal against the HMX frame.
Dhuper discloses a patient interface wherein:
the seal-forming structure comprises a sealing lip configured to seal against the HMX frame (Dhuper Figure 56,54; where ‘4296’ the sealing lip is with the seal forming structure (mask ‘4110’), that is configured to seal against the HMX ‘4299’ framed by the HMX frame ‘4290’, [0315-0317]).
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 patient interface of modified Brambilla in view of Harrington to include a sealing lip configured to seal against the HMX frame as taught by Dhuper, since, it allows for the HMX assembly to be easier to insert and remove from the plenum chamber (Dhuper [0317]), thereby improving the convenience and efficiency during HMX material replacement for example.
Regarding claim 74, modified Brambilla in view of Harrington, further in view of Dhuper further discloses the patient interface of claim 72, wherein the sealing lip is configured to seal around the entire perimeter of the HMX frame (Dhuper Figures 54,56; where the sealing lip ‘4296’ seals around the entire perimeter of the HMX frame ‘4290’ as modified);
such that all of the flow of air at the therapeutic pressure passes through the material before entering the patient's airways and all of the gas exhaled by the patient passes through the material before exiting to ambient through the vent holes (Brambilla Figure 4; where the material ‘12’ with layers ’92,94,96’ is positioned within the plenum chamber ‘24’ such that the gas exhaled by the patient must pass through the material ‘12’ before exiting to ambient through the vent holes, ‘601’ of Figure 1, [0054]; vented to ambient of exhalation).
Claim 73 is rejected under 35 U.S.C. 103 as obvious over Brambilla (US 20140276177 A1) in view of Bordewick (WO 2007117716 A2) further in view of Harrington (WO 2015013761 A1) further in view of Dhuper (WO 2013112470 A1) and even further in view of Finch (WO 2017011864 A1).
Regarding claim 73, modified Brambilla in view of Harrington, further in view of Dhuper further discloses the patient interface of claim 72, comprising the sealing lip (Dhuper Figure 56,54; where ‘4296’ the sealing lip is with the seal forming structure (mask ‘4110’), that is configured to seal against the HMX ‘4299’ framed by the HMX frame ‘4290’, [0315-0317]);
and vent holes (Brambilla Figure 1; ‘60’ vent holes).
Modified Brambilla in view of Harrington, further in view of Dhuper fails to disclose a sealing lip bypass opening.
Finch discloses a patient interface wherein:
the lip includes a bypass opening configured to allow at least a portion of the flow of air at the therapeutic pressure to bypass the material before entering the patient's airways and to allow at least a portion of the gas exhaled by the patient to bypass the material before exiting to ambient through the vent (Finch Figure 27; where ‘BF1,BF2’ is the lip covering the material ‘6005’ and ‘LP1,LP2’ is the bypass opening and the gas exhaled by the patient to bypass the material ‘6005’ before exiting to ambient through the vent ‘590’ (Figure 6), [0219]; the bypass openings ‘LP1,LP2’ ensure that air entering the chamber bypasses the HMX material ‘6005’ thereby limiting moisture loss).
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 patient interface of modified Brambilla in view of Harrington, further in view of Dhuper to include a bypass opening as taught by Finch with the sealing lip, since if there was a leak in the mask, the bypass opening would allow for inspiratory flow to bypass the HMX material, limiting any moisture loss from the HMX material (Finch [0219]).
Conclusion
The following prior art were considered but not used on a 35 U.S.C. § 102 or 103 rejection:
Barlow (EP 3517156 A1): alternate mouth hole and nasal hole for the seal forming structure.
Scheiner (US 20200246572 A1): alternate seal forming structure and vent holes.
Gusky (US 20160095996 A1): similar nasal interface assembly with HMX material and vent assembly.
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/AISLINN M JONES/Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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