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 .
Claim Objections
Claim 17 is objected to because of the following informalities: “the seal” in line 9 of claim 17 should read “the internal seal”, and “the seal” in line 15 of claim 17 should read “the external seal” for continuity and clarity.
Appropriate correction is required.
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.
Claims 18, 28, and 33 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.
Regarding claim 18, the phrase "optionally further comprises" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The limitations following the phrase “optionally further comprising” being “a cap wall which accommodates the gas opening so that the opening is coaxial with the central axis” in lines 5-6, and “the internal portion being defined by the cap wall and the internal wall” in lines 8-9.
For examination purposes, Examiner is taking the limitations “a cap wall which accommodates the gas opening so that the opening is coaxial with the central axis” in lines 5-6, and “the internal portion being defined by the cap wall and the internal wall” in lines 8-9 of claim 18 to be inclusive of the “cap wall”.
Regarding claim 28, the phrase "optionally further comprises" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The limitations following the phrase "optionally further comprises" being “a cap wall which accommodates the gas opening and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis, the internal portion being defined by the cap wall and the internal wall.” in lines 24-27.
For examination purposes, Examiner is taking the limitations “a cap wall which accommodates the gas opening and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis, the internal portion being defined by the cap wall and the internal wall” in lines 24-27 of claim 28 to be inclusive of the “cap wall”.
Regarding claim 33, the phrase " further optionally" renders the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The limitation following the phrase “further optionally” being “snap fitting” in line 3.
For examination purposes, Examiner is taking claim 18 to be inclusive of a “snap fitting” for detaching the seal.
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 17 and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Brambilla (US 20170361046 A1) in view of Corn (US 5370110 A) and Moenning (EP 2367589 B1).
Regarding claim 17, Brambilla discloses a medical ventilation mask (FIG. 9 Patient Interface 10a as set forth in [0064]) having a central axis (As shown in the figure below), the medical ventilation mask comprising, at least when the mask is ready for use: a gas opening (FIG. 9 Nozzle 54 as set forth in [0064]) configured to be connected, in fluid communication to a ventilation machine (FIG. 9 Flow 62 delivered by the flow generator to provide a supply 66 of breathable gas to the patient through the nozzle 54 as set forth in [0064]) and defining a location of a reference plane perpendicular to the central axis (Shown in the annotated figure below); a mask frame (Shown in the annotated figure below) having an internal portion (FIG. 9 The portion of the mask frame exposed to the user in connection with the first seal 50) and an external portion (FIG. 9 The portion of the mask frame exposed to the environment in connection with the second seal 52) and accommodating the gas opening so as to provide fluid communication of the gas opening with the internal portion, the external portion overlaying said internal portion at least along a part of an extension thereof (The internal and external portions extending in the direction of the central axis from the reference plane) along the central axis and including an auxiliary space therebetween (FIG. 9 The space formed between the first seal 50 and second seal 52 where the leak flow is contained and directed as set forth in [0064], referenced as the second space in claim 1);
an internal seal (FIG. 9 The first seal 50 as set forth in [0064]) connected to said internal portion at one end of the seal (Shown in the annotated figure below) and having an internal rim (Internal rim shown in the annotated figure below) at another end thereof, and configured for contacting with the face of a subject so that the internal portion of the mask frame and the internal seal define with the face of a subject a ventilation cavity (The first seal is adapted to contact the patient's face and seal a first space between the patient interface and the patient's face at a first positive pressure as set forth in claim 1) in fluid communication with the gas opening for delivering pressurized ventilation gas to the airways of the subject (FIG. 9 Flow 62 delivered by the flow generator to provide a supply 66 of breathable gas to the patient as set forth in [0064], which passes through nozzle 54 to the internal portion of the mask frame), said internal rim being spaced from the reference plane along the central axis to a first distance D1 (As shown in the annotated figure below);
an external seal (FIG. 9 The second seal 52 as set forth in [0064]) connected to said external portion at one end of the seal (Shown in the annotated figure below) and having an external rim (External rim shown in the annotated figure below) at another end thereof, and configured for contacting with the face of the subject at a location spaced from the internal rim in a direction perpendicular to the central axis (The second seal adapted to contact the patient's face and seal a second space between the patient interface and the patient's face at a second positive pressure, the second space surrounding the first space as set forth in claim 1, the second space surrounding the first space indicating that the external rim is perpendicularly located from internal rim in reference to the central axis), so that said external portion of the mask frame with its auxiliary space and the external seal define with the face of a subject a vacuum cavity (The second seal adapted to contact the patient's face and seal a second space between the patient interface and the patient's face at a second positive pressure, the second space surrounding the first space as set forth in claim 1; FIG 9 The vacuum cavity in the auxiliary space being the positive pressure caused by the leak flow 58 that occurs between the first seal 50 and the second seal 52 being effectively re-circulated as set forth in [0064]), said external rim being spaced from the reference plane along the central axis to a second distance D2 (As shown in the annotated figure below);
and at least one vacuum outlet port connected to the mask frame (Vacuum Outlet port as shown in the annotated figure below) so as to provide fluid communication between said auxiliary space and a vacuum line (FIG. 9 The auxiliary space formed between the first seal 50 and second seal 52, referenced as the second space in claim 1, directs the leak flow and then re-circulated flow as set forth in [0064], the fluid communication shown by the arrows representing the leak and re-circulated leak flow, the vacuum line shown in the annotated figure below), applying vacuum to the vacuum cavity, simultaneously with, and without interrupting, the ventilation in the ventilation cavity (FIG. 9 The re-circulated leak flow 60 is added to the flow 62 delivered by the flow generator to provide a supply 66 of breathable gas to the patient as set forth in Abstract, [0017], [0064], and claim 11, the positive pressure of the second space due to the direction and re-circulation of the leak flow which is happening simultaneously and not interrupting the flow generator’s supply of gas to the patient).
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Brambilla does not explicitly disclose the vacuum to the cavity provides aerosol clearance.
However, Corn teaches that vacuum supplied to a cavity provides aerosol clearance (Corn: FIG. 1 Tube 16 is connected to a suitable vacuum source, and when the vacuum source is activated, any leaked vapor or gas which is present within the environment of the hood is removed from the hood through tube 16 and is vented outside as set forth in col. 5 lines 5-11).
Brambilla and Corn are both considered to be analogous to the claimed invention because they are in the same field of medical breathing interfaces supplied with a vacuum force. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brambilla to incorporate the teaching of Moenning and include that the vacuum supplied to a cavity provides aerosol clearance (Corn: FIG. 1 Tube 16 is connected to a suitable vacuum source, and when the vacuum source is activated, any leaked vapor or gas which is present within the environment of the hood is removed from the hood through tube 16 and is vented outside as set forth in col. 5 lines 5-11). Doing so would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that given the well-known concept that the breath exhaled by a user contains moisture from the mouth and lungs in the form of water vapor, the leak flow directed through the auxiliary space would be able to remove aerosols exhaled by the subject during ventilation and escape with excess ventilation gas and exhaled breath leak from the ventilation cavity into the vacuum cavity.
Brambilla as modified is silent as to whether the second distance D2 is longer than the first distance D1.
However, Moenning teaches wherein a second distance D2 (Moenning: The distance between a reference plane defined by the gas port 22 as set forth in [0020] and the rim of seal 56 as set forth in [0024] as shown in the annotated figure below) is longer than the first distance D1 (Moenning: The distance between a reference plane defined by the gas port 22 as set forth in [0020] and the rim of seal 56 as set forth in [0019] as shown in the annotated figure below).
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Brambilla and Moenning are both considered to be analogous to the claimed invention because they are in the same field of medical nose and mouth face masks comprising a dual seal structure for forming a seal with the user’s face and provide a negative pressure/vacuum. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brambilla to incorporate the teaching of Moenning and include wherein a second distance D2 (Moenning: The distance between a reference plane defined by the gas port 22 as set forth in [0020] and the rim of seal 56 as set forth in [0024] as shown in the annotated figure) is longer than the first distance D1 (Moenning: The distance between a reference plane defined by the gas port 22 as set forth in [0020] and the rim of seal 56 as set forth in [0019] as shown in the annotated figure). Doing so would ensure the mask is able to properly engage with the user by enabling the seal to correspond with the contour of a user’s face at a given location (Moenning: As set forth in [0019 and [0024]).
Regarding claim 19, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Brambilla as modified fails to explicitly disclose the medical ventilation mask, wherein a ratio D1:D2 is at least 1: 1.10.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the ratio between the D1 and D2 distances at least 1: 1.10 in the device of Brambilla as modified by Moenning because Applicant has not disclosed that the specific 1: 1.10 ratio provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states on page 6 paragraph 3 that “Regarding the distances D1 and D2, a difference therebetween should be such as to suit natural topography of the human face where a location at which the external seal is to contact the face is further from the external portion of the mask, than a location at which the internal rim is to contact the face”, which would be true for any D1:D2 ratio that allows for the external seal to contact the face at a location further than the internal rim to suit the topography of the human face. One of ordinary skill in the art, furthermore, would have expected the distance ratio of modified Brambilla, and Applicant’s D1:D2 ratio, to perform equally well because both mechanisms perform the same function of ensuring the mask is able to properly engage with the user by enabling the seal to correspond with the contour of a user’s face at a given location, specifically wherein the seals suit the natural topography of the human face where a location at which the external seal is to contact the face is further from the external portion of the mask, than a location at which the internal rim is to contact the face.
Therefore, it would have been prima facie obvious to further modify Brambilla as modified by Moenning to obtain the invention as specified in claim 19, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired fit and seal of the mask and thus fails to patentably distinguish over the prior art of modify Brambilla as modified by Moenning.
Regarding claim 20, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Brambilla as modified further discloses the medical ventilation mask, wherein said internal rim comprises a curved internal lip open towards an interior of the internal portion (Shown in the annotated figure below).
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Regarding claim 21, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Brambilla as modified further discloses the medical ventilation mask, wherein the external rim comprises a curved external lip.
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Regarding claim 22, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 21 above.
Brambilla as modified fails to explicitly disclose the medical ventilation mask, wherein said curved external lip is open away from the auxiliary space.
However, the fifth embodiment of Brambilla teaches wherein said curved external lip is open away from the auxiliary space (As shown in the annotated figure below).
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It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brambilla to incorporate the teachings of the fifth embodiment of Brambilla and include wherein curved external lip is open away from the auxiliary space (As shown in the annotated figure). Doing so would provide an improved seal by the vacuum line sucking any leak flow that may occur between the first and second seals and deforming the seals and the skin between them, into the position shown in the embodiment of FIG. 7b (As set forth in [0062]).
Regarding claim 23, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 21 above.
Brambilla as modified further discloses the medical ventilation mask, wherein said curved external lip is open towards the auxiliary space.
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Regarding claim 24, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Brambilla as modified further discloses the medical ventilation mask, wherein the external portion has a nose bridge area (As shown in the annotated figure below).
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Regarding claim 25, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 24 above.
Brambilla as modified further discloses the medical ventilation mask, wherein the external portion comprises a chin area oppositely spaced from the nose bridge area along a direction perpendicular to the central axis (As shown in the annotated figure below).
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Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Brambilla (US 20170361046 A1) in view of Moenning (EP 2367589 B1) as applied to claim 17, in further view of Jin (CN 206621641 U) (The machine translation generated 09/15/2025 is relied upon for the following rejection).
Regarding claim 18, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Brambilla as modified is silent as to the specific configuration of how the mask frame’s internal and external portions are structured and how they are connected to the internal and external seals, wherein the mask frame has an external wall and an internal wall spaced inwardly from the external wall in a direction perpendicular to the central axis, the external wall defining at least partially said external portion of the mask frame, and the internal wall defining at least partially said internal portion of the mask frame, and wherein the mask frame optionally further comprises a cap wall which accommodates the gas opening so that the opening is coaxial with the central axis, and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis, the internal portion being defined by the cap wall and the internal wall.
However, Jin provides and teaches a configuration of how the mask frame’s internal and external portions are structured and how they are connected to the internal and external seals, wherein the mask frame has an external wall (Jin: FIG. 2 The Inner wall of the protective cover 2 as set forth on page 3 paragraph 4 and shown in the annotated figure below) and an internal wall (Jin: FIG. 2 The Oxygen hood 1 as set forth on page 3 paragraph 4 and 11 and shown in the annotated figure below) spaced inwardly from the external wall in a direction perpendicular to the central axis (Jin: The internal wall is spaced inwardly from the external wall as seen in FIG. 2, the internal wall within the space defined by the external wall, and therefore located in a perpendicular fashion from the central axis), the external wall defining at least partially said external portion of the mask frame (Jin: Shown in the annotated figure below), and the internal wall defining at least partially said internal portion of the mask frame (Jin: Shown in the annotated figure below), and wherein the mask frame optionally further comprises a cap wall (Jin: FIG. 2 The outer wall of the protective cover 2 as set forth on page 3 paragraph 4 and shown in the annotated figure below) which accommodates the gas opening (Jin: FIG. 2 Breathing tube 5 as set forth on page 3 paragraph 4) so that the opening is coaxial with the central axis (Jin: Shown in the annotated figure below), and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis (Jin: The internal and external walls are connected at a location between sliding sleeve 4 and opening 51 in a perpendicular direction relative to the axis as shown in FIG. 2), the internal portion being defined by the cap wall and the internal wall (Jin: The internal portion is shown in the annotated figure below; Examiner is taking the term “define” to mean making a clear outline, the cap wall and internal wall both outline the curvature and space of the internal portion, more directly in the case of the internal wall which marks the boundaries of the internal portion).
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Brambilla and Jin are both considered to be analogous to the claimed invention because they are in the same field of medical face masks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the specific configuration of how the mask frame’s internal and external portions are structured and connected to the internal and external seals of Brambilla to incorporate the structural teaching of Jin and include wherein the mask frame has an external wall (Jin: FIG. 2 The Inner wall of the protective cover 2 as set forth on page 3 paragraph 4 and shown in the annotated figure) and an internal wall (Jin: FIG. 2 The Oxygen hood 1 as set forth on page 3 paragraph 4 and 11 and shown in the annotated figure) spaced inwardly from the external wall in a direction perpendicular to the central axis (Jin: The internal wall is spaced inwardly from the external wall as seen in FIG. 2, the internal wall within the space defined by the external wall, and therefore located in a perpendicular fashion from the central axis), the external wall defining at least partially said external portion of the mask frame (Jin: Shown in the annotated figure), and the internal wall defining at least partially said internal portion of the mask frame (Jin: Shown in the annotated figure), and wherein the mask frame optionally further comprises a cap wall (Jin: FIG. 2 The outer wall of the protective cover 2 as set forth on page 3 paragraph 4 and shown in the annotated figure) which accommodates the gas opening (Jin: FIG. 2 Breathing tube 5 as set forth on page 3 paragraph 4) so that the opening is coaxial with the central axis (Jin: Shown in the annotated figure), and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis (Jin: The internal and external walls are connected at a location between sliding sleeve 4 and opening 51 in a perpendicular direction relative to the axis as shown in FIG. 2), the internal portion being defined by the cap wall and the internal wall (Jin: The internal portion is shown in the annotated figure; Examiner is taking the term “define” to mean making a clear outline, the cap wall and internal wall both outline the curvature and space of the internal portion, more directly in the case of the internal wall which marks the boundaries of the internal portion). Doing so provides a structural means of separation between the internal and external seals (Jin: FIG. 2 Sealing strips 3) to enable the leak-proof nature of the mask (Jin: Abstract).
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Brambilla (US 20170361046 A1) in view of in view of Corn (US 5370110 A) and Moenning (EP 2367589 B1) as applied to claim 24 and 25, in further view of Shi (CN 205796201 U) (The machine translation generated 09/15/2025 is relied upon for the following rejection).
Regarding claim 26, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 24 above.
Brambilla further discloses at least one vacuum outlet port so as to provide fluid communication between said auxiliary space and a vacuum line (FIG. 9 The auxiliary space formed between the first seal 50 and second seal 52, referenced as the second space in claim 1, directs the leak flow and then re-circulated flow as set forth in [0064], the fluid communication shown by the arrows representing the leak and re-circulated leak flow, the vacuum line shown in the annotated figure below), where the vacuum force is provided by the re-circulation is performed by the nozzle (FIG. 9 Nozzle 54).
Brambilla as modified fails to explicitly disclose the medical ventilation mask, wherein said vacuum outlet port is positioned in proximity of the nose bridge area.
However, Shi teaches wherein a port (Shi: FIG. 1 Negative pressure pipe 8 as set forth on page 4 paragraph 6) working in conjunction with the sealing element of the mask is positioned in proximity of the nose bridge area (Shi: As shown in FIG. 1).
Brambilla and Shi are both considered to be analogous to the claimed invention because they are in the same field of medical face masks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of vacuum outlet port of Brambilla to incorporate the teaching of the vacuum port of Shi wherein a port (Shi: FIG. 1 Negative pressure pipe 8 as set forth on page 4 paragraph 6) is positioned in proximity of the nose bridge area (Shi: As shown in FIG. 1). Doing so would have been obvious to one of ordinary skill in the art because Applicant has not disclosed that the specific port location provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states on page 21 last paragraph that “the two vacuum ports are positioned in proximity to weak sealing spots beings nose bridge and chin areas of the mask”, which does not provide evidence of any form of advantage. One of ordinary skill in the art, furthermore, would have expected the vacuum outlet port location of modified Brambilla, and Applicant' s vacuum outlet port location, to perform equally well because both mechanisms perform the same function of or removing aerosols exhaled by the subject during the ventilation and escaped with excess ventilation gas and exhaled breath leak from the ventilation cavity into the vacuum cavity.
Therefore, it would have been prima facie obvious to further modify Brambilla as modified with Shi to obtain the invention as specified in claim 26, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired function of the vacuum outlet port despite its location.
Regarding claim 27, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 25 above.
Brambilla as modified fails to explicitly disclose the medical ventilation mask, further comprising a pressure regulating port located in proximity of the chin area and providing fluid communication between said external portion and an exterior of the mask.
However, Shi teaches a pressure regulating port (Shi: FIG. 1 Exhaust pipe 6 as set forth on page 3 in paragraph 3 of the “Preferred Embodiment” section) located in proximity of the chin area (Shi: As shown in FIG. 1) and providing fluid communication between a portion of the mask (Shi: FIG. 1 Cavity 4 as set forth on page 3 in paragraph 3 of the “Preferred Embodiment” section) and an exterior of the mask (Shi: As shown in FIG. 1).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brambilla to incorporate the pressure regulating port of Shi between the external portion and an exterior of the mask, specifically, wherein a pressure regulating port (Shi: FIG. 1 Exhaust pipe 6 as set forth on page 3 in paragraph 3 of the “Preferred Embodiment” section) located in proximity of the chin area (Shi: As shown in FIG. 1) and providing fluid communication between a portion of the mask (Shi: FIG. 1 Cavity 4 as set forth on page 3 in paragraph 3 of the “Preferred Embodiment” section) and an exterior of the mask (Shi: As shown in FIG. 1). Doing so would provide a method of pressure control ensuring the pressure in the cavity is suitable for its desired function (Shi: As set forth on page 3 in paragraph 3 of the “Preferred Embodiment” section).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Brambilla (US 20170361046 A1) in view of Corn (US 5370110 A) and Jin (CN 206621641 U) (The machine translation generated 09/15/2025 is relied upon for the following rejection).
Regarding claim 28, a medical ventilation mask (FIG. 9 Patient Interface 10a as set forth in [0064]) having a central axis (As shown in the figure below), the medical ventilation mask comprising, at least when the mask is ready for use: a mask frame (Shown in the annotated figure below) having an internal portion (FIG. 9 The portion of the mask frame exposed to the user in connection with the first seal 50) and an external portion (FIG. 9 The portion of the mask frame exposed to the environment in connection with the second seal 52) and an auxiliary space between the portions (FIG. 9 The space formed between the first seal 50 and second seal 52 where the leak flow is contained and directed as set forth in [0064], referenced as the second space in claim 1); a gas opening (FIG. 9 Nozzle 54 as set forth in [0064]) connectable to a ventilation machine to provide fluid communication therewith of the internal portion of the mask frame (FIG. 9 Flow 62 delivered by the flow generator to provide a supply 66 of breathable gas to the patient as set forth in [0064], which passes through nozzle 54 to the internal portion of the mask frame for delivery to the user);
an internal seal (FIG. 9 The first seal 50 as set forth in [0064]) having an internal rim (Internal rim shown in the annotated figure below) at another end thereof at which the internal seal is configured for contacting with the face of a subject so that the internal portion and the internal seal define with the face of a subject a ventilation cavity (The first seal is adapted to contact the patient's face and seal a first space between the patient interface and the patient's face at a first positive pressure as set forth in claim 1) in fluid communication with the gas opening for delivering pressurized ventilation gas to the airways of the subject (FIG. 9 Flow 62 delivered by the flow generator to provide a supply 66 of breathable gas to the patient as set forth in [0064], which passes through nozzle 54 to the internal portion of the mask frame);
an external seal (FIG. 9 The second seal 52 as set forth in [0064]) having an external rim (External rim shown in the annotated figure below) at another end thereof at which the external seal is configured for contacting with the face of the subject at a location spaced from the internal rim at least in a direction perpendicular to the central axis (The second seal adapted to contact the patient's face and seal a second space between the patient interface and the patient's face at a second positive pressure, the second space surrounding the first space as set forth in claim 1, the second space surrounding the first space indicating that the external rim is perpendicularly located from internal rim in reference to the central axis), so that said external portion with its auxiliary space and the internal seal define with the face of a subject a vacuum cavity (The second seal adapted to contact the patient's face and seal a second space between the patient interface and the patient's face at a second positive pressure, the second space surrounding the first space as set forth in claim 1; FIG 9 The vacuum cavity in the auxiliary space being the positive pressure caused by the leak flow 58 that occurs between the first seal 50 and the second seal 52 being effectively re-circulated as set forth in [0064]);
at least one vacuum outlet port connected to the mask frame (Vacuum Outlet port as shown in the annotated figure below) to provide fluid communication between said auxiliary space and a vacuum line (FIG. 9 The auxiliary space formed between the first seal 50 and second seal 52, referenced as the second space in claim 1, directs the leak flow and then re-circulated flow as set forth in [0064], the fluid communication shown by the arrows representing the leak and re-circulated leak flow, the vacuum line shown in the annotated figure below), simultaneously with, and without interrupting, the ventilation in the ventilation cavity (FIG. 9 The re-circulated leak flow 60 is added to the flow 62 delivered by the flow generator to provide a supply 66 of breathable gas to the patient as set forth in Abstract, [0017], [0064], and claim 11, the positive pressure of the second space due to the direction and re-circulation of the leak flow which is happening simultaneously and not interrupting the flow generator’s supply of gas to the patient);
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Brambilla does not explicitly disclose the vacuum to the cavity provides aerosol clearance.
However, Corn teaches that vacuum supplied to a cavity provides aerosol clearance (Corn: FIG. 1 Tube 16 is connected to a suitable vacuum source, and when the vacuum source is activated, any leaked vapor or gas which is present within the environment of the hood is removed from the hood through tube 16 and is vented outside as set forth in col. 5 lines 5-11).
Brambilla and Corn are both considered to be analogous to the claimed invention because they are in the same field of medical breathing interfaces supplied with a vacuum force. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brambilla to incorporate the teaching of Moenning and include that the vacuum supplied to a cavity provides aerosol clearance (Corn: FIG. 1 Tube 16 is connected to a suitable vacuum source, and when the vacuum source is activated, any leaked vapor or gas which is present within the environment of the hood is removed from the hood through tube 16 and is vented outside as set forth in col. 5 lines 5-11). Doing so would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that given the well-known concept that the breath exhaled by a user contains moisture from the mouth and lungs in the form of water vapor, the leak flow directed through the auxiliary space would be able to remove aerosols exhaled by the subject during ventilation and escape with excess ventilation gas and exhaled breath leak from the ventilation cavity into the vacuum cavity.
Brambilla as modified is silent as to the specific configuration of how the mask frame’s internal and external portions are structured and how they are connected to the internal and external seals, wherein an external wall and an internal wall spaced inwardly from the external wall at least along a majority of lengths of these walls along the central axis, the internal wall defining at least partially an internal portion of the mask frame, the external wall defining at least partially an external portion of the mask frame including an auxiliary space between the walls, an internal seal connected to said internal wall at one end, and an external seal connected to said external wall at one end, and wherein the mask frame optionally further comprises a cap wall which accommodates the gas opening and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis, the internal portion being defined by the cap wall and the internal wall.
However, Jin provides and teaches a configuration of how the mask frame’s internal and external portions are structured and how they are connected to the internal and external seals, wherein an external wall (Jin: FIG. 2 The Inner wall of the protective cover 2 as set forth on page 3 paragraph 4 and shown in the annotated figure below) and an internal wall (Jin: FIG. 2 The Oxygen hood 1 as set forth on page 3 paragraph 4 and 11 and shown in the annotated figure below) spaced inwardly from the external wall at least along a majority of lengths of these walls along the central axis (Jin: The internal wall is spaced inwardly from the external wall for the whole length of the walls along the central axis as seen in annotated FIG. 2), the internal wall defining at least partially an internal portion of the mask frame (Jin: Shown in the annotated figure below), the external wall defining at least partially an external portion of the mask frame (Jin: Shown in the annotated figure below) including an auxiliary space between the walls (Jin: The space between the oxygen hood 1 and protective cover 2), an internal seal connected to said internal wall at one end, and an external seal connected to said external wall at one end (Jin: FIG. 2 Sealing strips 3), and wherein the mask frame optionally further comprises a cap wall (Jin: FIG. 2 The outer wall of the protective cover 2 as set forth on page 3 paragraph 4 and shown in the annotated figure below) which accommodates the gas opening (Jin: FIG. 2 Breathing tube 5 as set forth on page 3 paragraph 4) and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis (Jin: The internal and external walls are connected at a location between sliding sleeve 4 and opening 51 along and in a perpendicular direction relative to the axis as shown in FIG. 2), the internal portion being defined by the cap wall and the internal wall (Jin: The internal portion is shown in the annotated figure below; Examiner is taking the term “define” to mean making a clear outline, the cap wall and internal wall both outline the curvature and space of the internal portion, more directly in the case of the internal wall which marks the boundaries of the internal portion).
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It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the specific configuration of how the mask frame’s internal and external portions are structured and connected to the internal and external seals of Brambilla to incorporate the structural teaching of Jin and include wherein an external wall (Jin: FIG. 2 The Inner wall of the protective cover 2 as set forth on page 3 paragraph 4 and shown in the annotated figure below) and an internal wall (Jin: FIG. 2 The Oxygen hood 1 as set forth on page 3 paragraph 4 and 11 and shown in the annotated figure below) spaced inwardly from the external wall at least along a majority of lengths of these walls along the central axis (Jin: The internal wall is spaced inwardly from the external wall for the whole length of the walls along the central axis as seen in annotated FIG. 2), the internal wall defining at least partially an internal portion of the mask frame (Jin: Shown in the annotated figure below), the external wall defining at least partially an external portion of the mask frame (Jin: Shown in the annotated figure below) including an auxiliary space between the walls (Jin: The space between the oxygen hood 1 and protective cover 2), an internal seal connected to said internal wall at one end, and an external seal connected to said external wall at one end (Jin: FIG. 2 Sealing strips 3), and wherein the mask frame optionally further comprises a cap wall (Jin: FIG. 2 The outer wall of the protective cover 2 as set forth on page 3 paragraph 4 and shown in the annotated figure below) which accommodates the gas opening (Jin: FIG. 2 Breathing tube 5 as set forth on page 3 paragraph 4) and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis (Jin: The internal and external walls are connected at a location between sliding sleeve 4 and opening 51 along and in a perpendicular direction relative to the axis as shown in FIG. 2), the internal portion being defined by the cap wall and the internal wall (Jin: The internal portion is shown in the annotated figure below; Examiner is taking the term “define” to mean making a clear outline, the cap wall and internal wall both outline the curvature and space of the internal portion, more directly in the case of the internal wall which marks the boundaries of the internal portion). Doing so provides a structural means of separation between the internal and external seals (Jin: FIG. 2 Sealing strips 3) to enable the leak-proof nature of the mask (Jin: Abstract).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Brambilla (US 20170361046 A1) in view of Corn (US 5370110 A) and Jin (CN 206621641 U) (The machine translation is relied upon for the following rejection) as applied to claim 28, in further view of Moenning (EP 2367589 B1).
Regarding claim 29, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 28 above.
Brambilla further discloses, wherein the internal rim is spaced from the reference plane along the central axis to a first distance D1 (As shown in the annotated figure below) and the external rim is spaced from the reference plane along the central axis to a second distance D2 (As shown in the annotated figure below).
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Brambilla is silent as to whether the second distance D2 is longer than the first distance D1.
However, Moenning teaches wherein a second distance D2 (Moenning: The distance between a reference plane defined by the gas port 22 as set forth in [0020] and the rim of seal 56 as set forth in [0024] as shown in the annotated figure below) is longer than the first distance D1 (Moenning: The distance between a reference plane defined by the gas port 22 as set forth in [0020] and the rim of seal 56 as set forth in [0019] as shown in the annotated figure below).
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It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brambilla to incorporate the teaching of Moenning and include wherein a second distance D2 (Moenning: The distance between a reference plane defined by the gas port 22 as set forth in [0020] and the rim of seal 56 as set forth in [0024] as shown in the annotated figure) is longer than the first distance D1 (Moenning: The distance between a reference plane defined by the gas port 22 as set forth in [0020] and the rim of seal 56 as set forth in [0019] as shown in the annotated figure). Doing so would ensure the mask is able to properly engage with the user by enabling the seal to correspond with the contour of a user’s face at a given location (Moenning: As set forth in [0019 and [0024]).
Claims 30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Brambilla (US 20170361046 A1) in view of Corn (US 5370110 A) and Jin (CN 206621641 U) (The machine translation is relied upon for the following rejection) as applied to claim 28, in further view of Ng (US 9757533 B2).
Regarding claim 30, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 28 above.
Brambilla fails to explicitly disclose, wherein at least one of the internal seal and external seal is detachably attachable to the respective internal and external wall of the mask frame.
However, Ng teaches wherein a seal is detachably attachable to the respective wall of the mask frame (Ng: The mask system provides a modular design that allows the cushion to be interchanged as set forth in column 17 lines 30-40).
Brambilla and Ng are both considered to be analogous to the claimed invention because they are in the same field of medical face masks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified at least one of the internal seal and external seal of Brambilla to incorporate the teaching Ng, wherein the seal is detachably attachable to the respective wall of the mask frame (Ng: The mask system provides a modular design that allows the cushion to be interchanged as set forth in column 17 lines 30-40). Doing so would allow for the seal to be easily replaced, e.g., treatment requirements change, worn out or damaged (Ng: As set forth in column 17 lines 30-40).
Regarding claim 33, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 30 above.
Brambilla as modified by Ng further teaches, wherein at least one of the internal seal or the external seal is detachably attachable to the respective internal and external wall of the mask frame (Ng: The mask system provides a modular design that allows the cushion to be interchanged as set forth in column 17 lines 30-40) by a snap fitting (Ng: The tongue 1066 (see FIGS. 1C, 1D, and 8) of the cushion 1060 is inserted within a groove 1041 (see FIGS. 1C and 1D) provided along the perimeter of the frame 1040).
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Brambilla (US 20170361046 A1) in view of Jin (CN 206621641 U) (The machine translation is relied upon for the following rejection) as applied to claim 28, in further view of Todd (US 8573217 B2).
Regarding claim 31, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 28 above.
Brambilla as modified fails to explicitly disclose, the medical ventilation mask, further comprising a structural reinforcement arrangement extending between the cap wall and outer surface of the external wall.
However, Todd teaches a structural reinforcement arrangement (Todd: FIG. 2 Ribs 31 as set forth in column 3 lines 44-56) extending between two elements of the mask (Todd: FIG. 2 Ribs 31 extend from the second portion 19 to the first portion 17 of the breathing circuit interface 16 as set forth in column 3 lines 44-56).
Brambilla and Todd are both considered to be analogous to the claimed invention because they are in the same field of medical face masks. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brambilla to incorporate the teaching Todd, wherein a structural reinforcement arrangement (Todd: FIG. 2 Ribs 31 as set forth in column 3 lines 44-56) extending between two elements of the mask (Todd: FIG. 2 Ribs 31 extend from the second portion 19 to the first portion 17 of the breathing circuit interface 16 as set forth in column 3 lines 44-56), between the cap wall and outer surface of the external wall (The outer surface of the external wall being the portion of the external wall that connected to the sealing element of Brambilla as modified). Doing so would improve user grip on the device while holding it or interchanging elements (Todd: As set forth in column 3 lines 44-56).
Regarding claim 32, Brambilla as modified discloses the claimed invention substantially as claimed as set forth for claim 31 above.
Brambilla as modified by Ng further teaches, wherein said structural reinforcement arrangement comprises a plurality of reinforcement elements radially spaced from eac