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 .
Response to Amendment
Per the amendments to the claims, the drawing objection has been withdrawn, and the claim objections have been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-3 and 6-8 are rejected under 35 U.S.C. 103 as unpatentable over Davidson (US 8485192 B2) in view of Shiraishi (US 20210386135 A1).
Regarding claim 1, Davidson discloses a cushion for a face mask (Davidson Figure 1 ‘10’: cushion for a face mask), the cushion comprising:
an annular sealing wall having an annular sealing surface configured to engage a face of a user (Figure 3 below; annular sealing wall that compresses against a user’s face in the cushion);
an annular internal surface opposite the annular sealing surface (Figure 3 below; annular interior surface is oppositely oriented);
and a connector wall extending between a proximal end of the annular sealing wall and a proximal end of the annular support wall (Figure 3 below; where the connector wall extends between the annular sealing wall and a proximal end of the annular support wall);
an annular support wall extending circumferentially along the annular sealing wall (Figure 3 below; annular support wall that extends circumferentially along the annular sealing wall);
the annular support wall being configured to contact the annular internal surface in an instance in which the annular sealing wall is compressed into contact with the annular support wall (Figure 3 below; the annular sealing and annular support walls compress together in a spring like action and would come into contact when compressed into the user’s face).
Davidson fails to disclose the annular support wall having an opposite curvature to the annular support wall.
Shiraishi discloses a mask cushion wherein:
the annular support wall has an opposite curvature to the annular sealing wall (Figure 4 below; where there is an annular support wall that has opposite curvature to the annular sealing wall).
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 cushion of Davidson to include the annular support wall and the annular sealing wall with opposite curvature as taught by Shiraishi, since, it allows for the walls to be separate, thereby freely bending and deforming without interference with one another (Shiraishi [0026]).
Regarding claim 2, Modified Davidson further discloses the cushion of claim 1, wherein the annular sealing wall and the annular support wall are configured to define an acute angle therebetween (Figure 3 below; where the annular sealing wall and the annular support wall have an acute angle between them).
Regarding claim 3, Modified Davidson further discloses the cushion of claim 1, wherein a length of the annular sealing wall measured between the proximal end of the annular sealing wall and a distal end of the annular sealing wall is greater than a length of the annular support wall measured between the proximal end of the annular support wall and a distal end of the annular support wall (Figure 3 below; where the length of the annular sealing wall is greater than a length of the annular support wall).
Regarding claim 6, modified Davidson further discloses the cushion of claim 1, further comprises an end member connected to the connector wall on an opposite side of the annular support wall from the annular sealing wall (Figure 3 below; where the end member is on the opposite side of the annular support wall from the annular sealing wall and it is connected to the connector wall).
Regarding claim 7, modified Davidson further discloses the cushion of claim 6, wherein the end member is connected to the connector wall at a reflex angle such that the end member extends at least partially in an opposite direction of the annular sealing wall and the annular support wall for a given cross-section of the cushion (Figure 3 below; where the end member and the connector wall are connected and when the cushion is compressed they would create a reflex angle that extends in the opposite direction of the annular sealing and support wall).
Regarding claim 8, modified Davidson further discloses the cushion of claim 7, wherein compression of the cushion is configured to cause a connection between the end member and connector wall to flex and increase the reflex angle (Figure 3 below; where the end member and the connector wall are connected and when the cushion is compressed, they would create a reflex angle).
Claims 4-5 are rejected under 35 U.S.C. 103 as unpatentable over Davidson (US 8485192 B2) in view of Shiraishi (US 20210386135 A1) and further in view of Finken (US 2868195 A).
Regarding claim 4, Davidson further discloses the cushion of claim 1, wherein the cushion defines an annular gap between the annular sealing wall and the annular support wall in an instance in which the face of the user is not configured to compress compressing the annular sealing wall (Figure 3 below; this figure is when there are no faces being pressed to the cushion, the annular sealing wall and annular support wall compress into each other when the face cushion is compresses against a user’s face).
Modified Davidson is silent to a progressive cushioning behavior, whereby a first resilient force is less than a second resilient force.
Finken discloses a mask assembly wherein:
the annular gap and the annular support wall are configured to define a progressive cushioning behavior of the cushion whereby a first resilient force of the cushion upon initial contact of the face of the user with the annular sealing wall is less than a second resilient force of the cushion after the annular sealing wall is compressed into contact with the annular support wall (Figure 5 below; where there is an annular gap between the two walls, the ‘6’ annular sealing wall and the ‘5a’ annular support wall, where the annular sealing wall is less thick than the annular support wall, making the first resilient force when the user presses the annular sealing wall against the face less than when the annular sealing wall and the annular support wall are compressed into contact, because the annular support wall is thicker, the force will be bigger, where the walls are made of (Finken [024]); rubber, which is a resilient material (same as the material in the claimed invention)).
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 cushion of modified Davidson by having a thicker annular support wall than the annular sealing wall as taught by Finken in order to create a progressive cushioning behavior, because although Finken doesn’t explicitly describe progressive cushioning behavior and uses inflation to create a tight seal, it would have been readily understood by one of ordinary skill in the art that the use of a thicker outer wall than the inner wall, would create a progressive cushioning behavior, such that the force is less on a smaller thickness wall than a larger thickness wall. For example, during compression to a user’s face, the thinner, more flexible wall initially presses against the user’s face, followed by the thicker wall (annular support wall) which is less flexible due to thickness, providing a progressive resistance/ cushioning behavior. Additionally, because the same resilient material is used for both walls, (instant application vs. prior art), it would have been readily understood by one of ordinary skill in the art that altering the wall thickness would yield the predictable changes in cushioning behavior (MPEP 2143). Finally, the walls are provided to help equalize pressures throughout the annular gap when expanded and compressed to a user’s face (Finken [039]).
Regarding claim 5, modified Davidson in view of Finken further discloses the cushion of claim 4, wherein a surface area of the annular support wall in contact with the annular support surface of the annular sealing wall increases as force is applied to the annular sealing wall (Figure 3 below; where the surface area of the annular support wall increases in contact with the annular support surface of the annular sealing wall, as force is applied to the annular sealing wall, because of the spring like nature of the walls, compression, of the two walls against each other would increase this surface area of contact when force is applied (compression)).
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Figure 1: Annotated Figure 21 of Ki.
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Figure 2: Annotated Figure 19 of Ki.
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Figure 3: Annotated Figure 83 of Davidson.
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Figure 4: annotated Figure 5A of Shiraishi.
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Figure 5: annotated Figures 4-8 of Finken.
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Figure 6: recreated and annotated Figure 83 of Davidson to show the reflex angles as annotated by the arches.
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Figure 7: annotated Figure 14 of Eifler.
Claims 9 is rejected under U.S.C. 103 as obvious over Davidson (US 8485192 B2) in view of Shiraishi (US 20210386135 A1) and further in view of Ki (KR 101730831 B1).
Regarding claim 9, modified Davidson further discloses the cushion of claim 8.
Modified Davidson is silent to the end member comprising a face shield sealing wall configured to contact a face shield.
Ki discloses a face cushion,
wherein the end member further comprises a face shield sealing wall configured to contact a face shield (Figure 1 above; the end member has a face shield sealing wall portion that helps with the protrusions of Figure 2 above to provide a connection with the face shield of Figure 1).
It would have been obvious to modify the face cushion of modified Davidson to include a face shield sealing wall as taught by Ki, since, the face shield sealing wall allows for the face shield to better attach to the cushion (Ki [0048]).
Claims 10-13, 15-17 and 19 are rejected under U.S.C. 103 as obvious over Davidson (US 8485192 B2) in view of Ki (KR 101730831 B1).
Regarding claim 10, Davidson discloses a cushion comprising:
an annular sealing wall having an annular sealing surface configured to engage a face of a user (Figure 3 above; annular sealing wall that compresses against a user’s face);
an annular internal surface opposite the annular sealing surface (Figure 3 above; annular interior surface is oppositely oriented);
an annular support wall extending circumferentially along the annular sealing wall (Figure 3 above; annular support wall that extends circumferentially along the annular sealing wall);
the annular support wall being configured to contact the annular internal surface in an instance in which the annular sealing wall is compressed into contact with the annular support wall (Figure 3 above; the annular sealing and annular support walls compress together in a spring like action and would come into contact when compressed into the user’s face);
a connector wall extending between a proximal end of the annular sealing wall and a proximal end of the annular support wall (Figure 3 above; where the connector wall is extending between the proximal end of the annular sealing wall and a proximal end of the annular support wall);
an end member extending from the connector wall at a reflex angle in an opposite direction of the annular sealing wall and the annular support wall (Figure 6 above; where there is an end member extending from the connector wall, as labeled with the reflex angle of the structure, where it is seen that the reflex angle is in an opposite direction of the annular sealing wall and the annular support wall).
Davidson is silent to a face mask assembly with a transparent face shield and straps that are configured to secure the face mask assembly to the user and a breathing portion and wherein the cushion at least partially surrounds the breathing portion along the face of the user.
Ki discloses a face mask assembly (Figure 1 above), the face mask assembly comprising:
a transparent face shield configured to engage the end member of the cushion (Figure 1 above; the end member has a face shield sealing wall portion that helps with the protrusions of Figure 2 above to provide a connection with the face shield of Figure 1);
a breathing portion configured to cover a mouth and/or a nose (Figure 1 above; breathing portion that covers mouth and nose);
wherein the cushion is configured to at least partially surround the breathing portion along the face of the user (Figure 1 above; where the cushion extends circumferentially around the face shield);
and at least one strap configured to secure the face mask assembly to the user (Figure 1 above; where there are straps to help secure the face mask assembly to the user);
wherein the face mask assembly is configured to seal an internal volume between the face of the user and the face mask assembly (Figure 1 above; where the face mask assembly seals the internal volume between the face of a user and face mask assembly through the cushion);
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 face cushion of Davidson to include a face mask assembly with a transparent face shield, straps, and a breathing portion as taught by Ki, since, a face shield will protect the wearer’s eye area and most of the face, straps help to tighten the distance between the cushion and the face shield and because a breathing portion maintains tightness so that purified air can reach the wearer (Ki [0047], [0080], [0117]).
Regarding claim 11, modified Davidson further discloses the face mask assembly of claim 10, wherein the annular sealing wall and the annular support wall are configured to define an acute angle therebetween (Figure 3 above; where the annular sealing wall and the annular support wall have an acute angle between them).
Regarding claim 12, modified Davidson further discloses the face mask assembly of claim 10, wherein a length of the annular sealing wall measured between the proximal end of the annular sealing wall and a distal end of the annular sealing wall is greater than a length of the annular support wall measured between the proximal end of the annular support wall and a distal end of the annular support wall (Figure 3 above; where the length of the annular sealing wall is greater than a length of the annular support wall).
Regarding claim 13, modified Davidson further discloses the face mask assembly of claim 10, wherein the cushion defines an annular gap between the annular sealing wall and the annular support wall in an instance in which the face of the user is not compressing the annular sealing wall (Figure 3 above; this figure is when there are no faces being pressed to the cushion, the annular sealing wall and annular support wall compress into each other when the face cushion is compresses against a user’s face).
Regarding claim 15, modified Davidson further discloses the face mask assembly of claim 10, further comprises an end member connected to the connector wall on an opposite side of the annular support wall from the annular sealing wall (Figure 3 above; where the end member is on the opposite side of the annular support wall from the annular sealing wall and it is connected to the connector wall).
Regarding claim 16, modified Davidson further discloses the face mask assembly of claim 15, wherein the end member is connected to the connector wall at the reflex angle such that the end member extends at least partially in the opposite direction of the annular sealing wall and the annular support wall for a given cross-section of the cushion (Figure 3 above; where the end member and the connector wall are connected and when the cushion is compressed they would create a reflex angle that extends in the opposite direction of the annular sealing and support wall);
and wherein, compression of the cushion is configured to cause a connection between the end member and connector wall to flex and increase the reflex angle (Figure 3 above; where the end member and the connector wall are connected and when the cushion is compressed, they would create a reflex angle);
wherein the end member comprises a face shield sealing wall configured to contact a face shield (Figure 1 above; where the end member has a face shield sealing wall that is configured to contact a face shield).
Regarding claim 17, modified Davidson further discloses the face mask assembly of claim 10, wherein the end member is positioned on a first side of the connector wall and the annular sealing wall and the annular support wall extend from a second surface of the connector wall to a second side of the connector wall opposite to the first side (Figure 3 above; where the end member is at a first side of the connector wall (leftward) and the annular sealing and the annular support wall extend from a second surface of the connector wall to a second side of the connector wall opposite to the first side (rightward)).
Regarding claim 19, modified Davidson further discloses a respirator assembly comprising the face mask assembly of claim 10, wherein the breathing portion comprises at least one filter element configured to filter air entering the face mask assembly (Ki Figure 6; ‘53’ is a purifier that is attached to the breathing portion of the face mask assembly that purifies contaminated air from the outside to provide clean air to a user (filter), Ki TECHNICAL-FIELD [01]; where it is a respirator with a face mask assembly).
Claim 14 is rejected under U.S.C. 103 as obvious over Davidson (US 8485192 B2) in view of Ki (KR 101730831 B1) and further in view of Finken (US 2868195 A).
Regarding claim 14, modified Davidson further discloses the face mask assembly of claim 13.
Modified Davidson is silent to a progressive cushioning behavior, whereby a first resilient force is less than a second resilient force.
Finken discloses a mask assembly wherein:
the annular gap and the annular support wall are configured to define a progressive cushioning behavior of the cushion whereby a first resilient force of the cushion upon initial contact of the face of the user with the annular sealing wall is less than a second resilient force of the cushion after the annular sealing wall is compressed into contact with the annular support wall (Figure 5 above; where there is an annular gap between the two walls, the ‘6’ annular sealing wall and the ‘5a’ annular support wall, where the annular sealing wall is less thick than the annular support wall, making the first resilient force when the user presses the annular sealing wall against the face less than when the annular sealing wall and the annular support wall are compressed into contact, because the annular support wall is thicker, the force will be bigger, where the walls are made of (Finken [024]); rubber, which is a resilient material (same as the material in the claimed invention)).
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 cushion of modified Davidson by having a thicker annular support wall than the annular sealing wall as taught by Finken in order to create a progressive cushioning behavior, because although Finken doesn’t explicitly describe progressive cushioning behavior and uses inflation to create a tight seal, it would have been readily understood by one of ordinary skill in the art that the use of a thicker outer wall than the inner wall, would create a progressive cushioning behavior, such that the force is less on a smaller thickness wall than a larger thickness wall. For example, during compression to a user’s face, the thinner, more flexible wall initially presses against the user’s face, followed by the thicker wall (annular support wall) which is less flexible due to thickness, providing a progressive resistance/ cushioning behavior. Additionally, because the same resilient material is used for both walls, (instant application vs. prior art), it would have been readily understood by one of ordinary skill in the art that altering the wall thickness would yield the predictable changes in cushioning behavior (MPEP 2143). Finally, the walls are provided to help equalize pressures throughout the annular gap when expanded and compressed to a user’s face (Finken [039]).
Claim 18 is rejected under U.S.C. 103 as obvious over Davidson (US 8485192 B2) in view of Ki (KR 101730831 B1) and further in view of Eifler (CN 115400311 A).
Regarding claim 18, modified Davidson further discloses the face mask assembly of claim 10, wherein a second angle between the annular sealing wall and the connector wall and a third angle between the annular support wall and the connector wall are less than 90 degrees (Figure 3 above; where the second and third angle as described between the annular sealing wall and the connector wall and the annular support wall and the connector are less than 90 degrees because the angle is acute in the Figure – making it less than 90 degrees).
Modified Davidson fails to disclose a first angle being greater than 180*.
Eifler discloses a patient interface wherein:
a first angle between the end member and the connector wall is greater than 180 degrees (Figure 7 above; where the angle between the end member and the connector wall is greater than 180 degrees).
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 face mask assembly of modified Davidson by having the first angle be greater than 180* as taught by Eifler, since, since it allows for the face mask assembly to lock into place with the end of the end member (Eifler [0062]), which allows for improved securement and stability in the modified Davidson device.
Claim 20 is rejected under U.S.C. 103 as obvious over Ki (KR 101730831 B1) in view of Davidson (US 8485192 B2).
Regarding claim 20, Ki discloses a method of using the face mask assembly, the method comprising: holding the face mask assembly to a face of a user (Ki [01]; the mask is worn to protect a user’s face- thereby having the face mask assembly being held to a user’s face);
a cushion comprising (Figure 1 above; where the assembly is the cushion under skeleton attached to the face shield and the straps):
an annular sealing wall having an annular sealing surface configured to engage a face of a user (Figure 1 above; annular sealing wall that compresses against a user’s face);
an annular internal surface opposite the annular sealing surface (Figure 1 above; annular interior surface is oppositely oriented);
a transparent face shield configured to engage the end member of the cushion (Figure 1 above; the end member has a face shield sealing wall portion that helps with the protrusions of Figure 2 above to provide a connection with the face shield of Figure 1);
a breathing portion configured to cover a mouth and/or a nose (Figure 1 above; breathing portion that covers mouth and nose);
wherein the cushion is configured to at least partially surround the breathing portion along the face of the user (Figure 1 above; where the cushion extends circumferentially around the face shield);
and at least one strap configured to secure the face mask assembly to the user (Figure 1 above; where there are straps to help secure the face mask assembly to the user);
wherein the face mask assembly is configured to seal an internal volume between the face of the user and the face mask assembly (Figure 1 above; where the face mask assembly seals the internal volume between the face of a user and face mask assembly through the cushion);
securing the at least one strap about the user’s head; and compressing the cushion to form a seal between the annular sealing wall and the face of the user (Ki Figures 12 and 13; where the strap ‘700’ in an exploded view and connected view are shown to help form a seal between the cushion and a user’s face would be on the other side of the cushion).
Ki fails to disclose the method including an annular support wall.
Davidson discloses a method of using a cushion comprising:
an annular support wall extending circumferentially along the annular sealing wall (Figure 3 above; annular support wall that extends circumferentially along the annular sealing wall, cushion with an under cushion with an annular support wall to be compressed into a user’s face when they wear the face mask);
the annular support wall being configured to contact the annular internal surface in an instance in which the annular sealing wall is compressed into contact with the annular support wall (Figure 3 above; the annular sealing and annular support walls compress together in a spring like action and would come into contact when compressed into the user’s face);
a connector wall extending between a proximal end of the annular sealing wall and a proximal end of the annular support wall (Figure 3 above; where there is a connector wall extending between a proximal end of the annular sealing wall and a proximal end of the annular support wall);
an end member extending from the connector wall at a reflex angle in an opposite direction of the annular sealing wall and the annular support wall (Figure 3 above; where the end member and the connector wall are connected and when the cushion is compressed, they would create a reflex angle that extends in the opposite direction of the annular sealing and support wall).
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 method of using the face mask assembly of Ki to include an annular support wall as taught by Davidson, since, the arrangement of the two walls helps to provide a more gradual force, improves comfort, and allows a wider range of patients to achieve seal (Davidson [0081]).
Conclusion
The following prior art were considered but not used on a 35 U.S.C. § 102 or 103 rejection:
Mosca (EP 0304641 A1): A protective mask with a face shield and under-cushion assembly.
Bentley (CN 109414557 A): A patient interface that covers the nose with an under-cushion assembly.
Davidson (US 7658189 B2): An oronasal patient interface with an under-cushion assembly.
Boussignac (FR 2988003 A1): a respiratory mask with an under-cushion element.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is (571)272-3835. The examiner can normally be reached Monday-Friday 7:30-5, EO Friday 7:30-4.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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