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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the openings of claim 18 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The openings of claim 18 need reference characters in Figure 1 to distinguish from the openings ‘164’.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 4 and 20 are objected to because of the following informalities:
Claim 4: The recitation of “in which the face of the user is not compressing the annular sealing wall”, should read ---in which the face of the user is not configured to compress the annular sealing wall---.
Claim 20: The recitation of “holding the face mask assembly to a user face”, should read ---holding the face mask assembly to a face of a user---.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Davidson (US 8485192 B2).
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);
Regarding claim 2, 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, 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 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 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).
Regarding claim 5, Davidson further discloses the cushion of claim 4, 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 3 below and Davidson [0081], [0082], where the annular sealing wall handles the sealing and the annular support wall handles the physical pressure, Davidson Figure 31; where the deep compression to get a tight seal does increase when pressed against the face (1st force), and the bulk of the force goes towards the annular sealing wall which is more rigid and the annular support wall compresses to the annular sealing wall (2nd force), which helps to prevent the “bottom-out” feature of the lower face region for an effective sealing- making the 1st force be greater than the 2nd force).
Regarding claim 6, 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, 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, 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).
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
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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.
Claims 9-19 are rejected under U.S.C. 103 as obvious over Davidson (US 8485192 B2) in view of Ki (KR 101730831 B1).
Regarding claim 9, Davidson discloses the cushion of claim 8.
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 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]).
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);
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 cushion (Figure 1 above; transparent face shield);
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 Ki further discloses the face mask assembly of claim 10. Davidson further discloses 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 Ki further discloses the face mask assembly of claim 10. Davidson further discloses 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 Ki further discloses the face mask assembly of claim 10. Davidson further discloses 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 14, modified Ki further discloses the face mask assembly of claim 13. Davidson further discloses 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 3 above, where the annular sealing wall handles the sealing and the annular support wall handles the physical pressure, Davidson Figure 31; where the deep compression to get a tight seal does increase when pressed against the face (1st force), and the bulk of the force goes towards the annular sealing wall which is more rigid and the annular support wall compresses to the annular sealing wall (2nd force), which helps to prevent the “bottom-out” feature of the lower face region for an effective sealing- making the 1st force be greater than the 2nd force).
Regarding claim 15, modified Ki further discloses the face mask assembly of claim 10. Davidson further discloses comprising 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 Ki further discloses the face mask assembly of claim 15. Davidson further discloses 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 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).
Regarding claim 17, modified Ki further discloses the face mask assembly of claim 16, wherein the end member further comprises a face shield sealing wall configured to contact a face shield (Figure 1 above; end member extends circumferentially around, face shield sealing wall contacting a face shield).
Regarding claim 18, modified Ki further discloses the face mask assembly of claim 10,
wherein the transparent face shield comprises a plurality of openings (Figure 2 above; where there are protrusions that support the face shield, therefore, there must be openings in the face shield where the protrusions are to be coupled together);
and wherein the cushion comprises a plurality of protrusions configured to engage the plurality of openings to support the face shield (Figure 2 above; example of the protrusion to help support the face shield).
Regarding claim 19, modified Ki 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)).
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 user face (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);
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 cushion (Figure 1 above; transparent face shield);
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).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is 571-272-3835. The examiner can normally be reached Monday-Friday 8am-5pm, EO Friday 8am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785