DETAILED ACTION
This Office Action is in response to the filing of the application on 6/21/2023. Since the initial filing, no claims have been amended, added, or cancelled. Thus, claims 1-22 are pending in the application.
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 because Figs. 6-8 and 18-20 each fail to comply with 37 CFR 1.84(h)(1) whereby an exploded view must be shown embraced by a bracket to show the relationship between structural components. 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 1, 15, and 18-19 are objected to because of the following informalities:
Claim 1 recites the term “is configured” in line 6. Examiner suggests changing to read --being configured-- in order to correct a grammatical issue.
Claim 1 recites the term “lower members” in line 9. Examiner suggests changing to read --lower member-- in order to remove an erroneous plurality of lower members.
Claim 15 recites the language “is rotatable ;y secured together” in lines 10-11. Examiner suggests changing to read --being rotatably secured together-- in order to correct a typographical and grammatical error.
Claim 15 recites the term “lower members” in lines 11-12. Examiner suggests changing to read --lower member-- in order to remove an erroneous plurality of lower members.
Claim 18 recites the term “wherein,” in line 2. Examiner suggests changing to read --wherein-- to remove an unnecessary comma.
Claim 19 recites the language “wherein, wherein” in line 2. Examiner suggests changing to read --wherein-- in order to correct a typographical error.
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.
Claim 4 is 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.
Claim 4 recites the limitation "said filter substrate engagement member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Any remaining claims are rejected for being dependent on a rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11, 15-19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Danford (US Pat. 9,579,540) in view of Xu et al. (US Pub. 2004/0226563).
Regarding claim 1, Danford discloses an exhalation valve for use with a substrate for filtering air (see Figs. 1 and 4 where exhalation valves 104 and 106 are part of the mask, and capable of being used in a mask that incorporates a filter (which is not positively claimed)) comprising: an upper member having an outer surface and an inner surface (see Fig. 4 where exhalation valve 104 has a cap 116 that is an upper member, having an outer surface that is externally facing, and inner surface that faces the mask); a lower member (see Fig. 4 base 108); and an air passage member secured to said lower member (see Fig. 4 diaphragm 112). Danford also discloses where the cap of the exhalation valve can be manipulated (see Col. 7 lines 35-40).
The Danford embodiment lacks a detailed description of said exhalation valve is configured to traverse between a first ON position and a second OFF position, wherein, said upper member or said lower member is rotatable, wherein rotation of said upper member or said lower members orientates said exhalation valve in said first ON position or said second OFF position.
However, another Danford embodiment teaches a valve member (see Fig. 4 air admittance valve assembly 30, which is capable of being used for exhalation as seen in Col. 11 lines 28-31), where a cap can be configured to traverse between a first ON position and a second OFF position (see Col. 9 line 64 to Col. 10 line 37 and Fig. 4, where cap 38 of the valve 30 is able to be rotated such that the hole array 94 of the cap 38 aligns with the hole array 70 of the base 34 (this being an ON position allowing for a flow of air), and rotated to a second position where the hole array 94 does not align with the hole array 70 such that no air can flow though and is thus an OFF position), wherein, said upper member or said lower member is rotatable (see Col. 9 line 64 to Col. 10 line 37 where the cap 38 is an upper member and is rotatable), wherein rotation of said upper member or said lower members orientates said exhalation valve in said first ON position or said second OFF position (see Col. 9 line 64 to Col. 10 line 37, where rotation of the cap 38 results in changing of the valve 30 from its ON to its OFF position).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exhalation valve cap of Danford to rotate with a plurality of holes as taught by the intake valve of Danford, as it would allow for minute control over the amount of air being exhaled, and the applied air pressure to overcome the diaphragm (see Col. 11 lines 12-31).
In the alternative that the modified Danford device lacks a detailed description of the exhalation valve being for use with a substrate for filtering air, then it is taught by Xu.
Xu teaches a patient interface mask with an exhalation valve, where the exhalation valve includes a substrate for filtering air (see Fig. 2 where exhalation device 108 has a filter medium 120 sitting within the filter housing 118, and can be part of valve 124 as seen in Fig. 3 and [0071]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exhalation valve of the modified Danford device to include a filter as taught by Xu, as it would protect people other than the mask wearer from exhaled contaminants (Xu; see [0071]).
Regarding claim 2, the modified Danford device has wherein said exhalation valve further includes an intermediate member secured to said upper member (Danford; see Fig. 4 tubular post 144).
Regarding claim 3, the modified Danford device has wherein said exhalation valve further includes a filter substrate engagement member configured to secure said exhalation valve to a substrate (Xu; see Fig. 2 where a filter housing 118 engages with and holds the filter medium 120, and in the modified Danford device secures the filter onto the exhalation valve).
Regarding claim 4, the modified Danford device has wherein said filter substrate engagement member comprises a body configured to secure to said lower member (Xu; see Fig. 2 where a filter housing 118 engages with and holds the filter medium 120, and in the modified Danford device connects to and is secured onto the base 108 of the exhalation valve).
Regarding claim 5, the modified Danford device has wherein said exhalation valve further includes a substrate secured to said exhalation valve (Xu; see Fig. 2 filter medium 120).
Regarding claim 6, the modified Danford device has wherein said substrate is configured to filter air (Xu; see Fig. 2 filter medium 120).
Regarding claim 7, the modified Danford device has wherein said air passage member rests within said lower member (Danford; see Fig. 4 where diaphragm 112 is within the base 108).
Regarding claim 8, the modified Danford device has wherein said air passage member is movable within said lower member (Danford; see Fig. 4 diaphragm 112 which is understood to bend and thus move; see Col. 10 lines 57-63).
Regarding claim 9, the modified Danford device has wherein said air passage member is an elastic or pliable diaphragm (Danford; see Fig. 4 diaphragm 112; see also Col. 7 lines 7-8 where it is made of silicone and thus pliable and elastic).
Regarding claim 10, the modified Danford device has wherein when said exhalation valve is placed in the ON position, air passes through said exhalation valve (Danford; see Col. 9 line 64 to Col. 10 line 37, where rotation of the modified exhalation valve cap results in aligning the holes such that air flows through in the ON position).
Regarding claim 11, the modified Danford device has wherein when said exhalation valve is placed in the OFF position, air is prevented from passing through said exhalation valve (Danford; see Col. 9 line 64 to Col. 10 line 37, where rotation of the modified exhalation valve cap results in aligning the holes such that air does not flow through in the OFF position).
Regarding claim 15, Danford discloses an air filtration device (see Figs. 1 and 4 where exhalation valves 104 and 106 are part of a mask that can filter air between the intake and exhaust via valves) comprising: a substrate configured to cover portions of a user’s face (see Figs. 1 and 4 mask 14) an exhalation valve (see Fig. 4 exhalation valve 104), said exhalation valve comprising, an upper member having an outer surface and an inner surface (see Fig. 4 where exhalation valve 104 has a cap 116 that is an upper member, having an outer surface that is externally facing, and inner surface that faces the mask), a lower member (see Fig. 4 base 108), and an air passage member secured to said lower member (see Fig. 4 diaphragm 112), said upper member or said lower member is secured together (see Fig. 4 where cap 116 and base 108 are connected together). Danford also discloses where the cap of the exhalation valve can be manipulated (see Col. 7 lines 35-40).
The Danford embodiment lacks a detailed description of an exhalation valve traversable between a first ON position, whereby air is passed through said exhalation valve, and a second OFF position, whereby air is prevented from passing through said exhalation valve, said upper member or said lower member is rotatably secured together, wherein rotation of said upper member or said lower members orientates said exhalation valve in said first ON position or said second OFF position.
However, another Danford embodiment teaches a valve member (see Fig. 4 air admittance valve assembly 30, which is capable of being used for exhalation as seen in Col. 11 lines 28-31), where a cap can be configured to traverse between a first ON position and a second OFF position (see Col. 9 line 64 to Col. 10 line 37 and Fig. 4, where cap 38 of the valve 30 is able to be rotated such that the hole array 94 of the cap 38 aligns with the hole array 70 of the base 34 (this being an ON position allowing for a flow of air), and rotated to a second position where the hole array 94 does not align with the hole array 70 such that no air can flow though and is thus an OFF position), wherein, said upper member or said lower member is rotatably secured together (see Col. 9 line 64 to Col. 10 line 37 where the cap 38 is an upper member and is rotatable with respect to the base 34, to which it connects), wherein rotation of said upper member or said lower members orientates said exhalation valve in said first ON position or said second OFF position (see Col. 9 line 64 to Col. 10 line 37, where rotation of the cap 38 results in changing of the valve 30 from its ON to its OFF position).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exhalation valve cap of Danford to rotate with a plurality of holes as taught by the intake valve of Danford, as it would allow for minute control over the amount of air being exhaled, and the applied air pressure to overcome the diaphragm (see Col. 11 lines 12-31).
The modified Danford device lacks a detailed description of a substrate configured to cover portions of a user's face and filter air.
Xu teaches a patient interface mask with an exhalation valve, where the exhalation valve includes a substrate for filtering air, and covers at least a portion of the user’s face (see Fig. 2 where exhalation device 108 has a filter medium 120 sitting within the filter housing 118, and can be part of valve 124 as seen in Fig. 3 and [0071]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exhalation valve of the modified Danford device to include a filter as taught by Xu, as it would protect people other than the mask wearer from exhaled contaminants (Xu; see [0071]).
Regarding claim 16, the modified Danford device has wherein said exhalation valve further includes an intermediate member secured to said upper member (Danford; see Fig. 4 tubular post 144).
Regarding claim 17, the modified Danford device has wherein said exhalation valve further includes a filter substrate engagement member configured to secure said exhalation valve to said substrate (Xu; see Fig. 2 where a filter housing 118 engages with and holds the filter medium 120, and in the modified Danford device secures the filter onto the exhalation valve).
Regarding claim 18, the modified Danford device has wherein, said air passage member rests within said lower member (Danford; see Fig. 4 where diaphragm 112 is within the base 108).
Regarding claim 19, the modified Danford device has wherein said air passage member is movable within said lower member (Danford; see Fig. 4 diaphragm 112 which is understood to bend and thus move; see Col. 10 lines 57-63).
Regarding claim 22, the modified Danford device has wherein said substrate is a mask or respirator (Danford; see Figs. 1 and 4 mask 14 which contains the modified filter as taught by Xu).
Claims 12-14 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Danford in view of Xu as applied to claims 1 and 15 above, respectively, and further in view of Mikaelian et al. (US Pat. 12,403,338).
Regarding claims 12 and 20, the modified Danford device has wherein said exhalation valve includes a status indicator (Danford; see Fig. 4 where the physical rotational position of the holes of hole array 94 can be seen by a person, and indicate some status).
In the alternative that the modified Danford device lacks a detailed description of wherein said exhalation valve includes a status indicator, then it is taught by Mikaelian.
Mikaelian teaches a mask with a valve, where the valve includes a status indicator (see Figs. 11-12 where rotatable valve gate 1130 moves within a slot 1122 to align with the valve cap indicator 1126 to show the status of the valve).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exhalation valve of the modified Danford device to include a status indicator of the valve as taught by Mikaelian, as it would provide a clear visual signal to the user and others with regards to the open or closed position of the valve.
Regarding claims 13 and 21, the modified Danford device has wherein said exhalation valve status indicator includes text, images, colors, or combinations thereof (Mikaelian; see Figs. 11-12 where the status indicator includes valve cap indicator 1126 with text).
Regarding claim 14, the modified Danford device has wherein said status indicator is a window within said upper member (Mikaelian; see Figs. 11-12 where the slot 1122 acts as a window for the valve gate 1130 to move within and extend out therefrom, which is understood to be attached to the cap of the modified Danford device so that it is outward facing towards the environment/ other people).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Langford (US Pat. 10,220,224), Musgrove (US Pat. 11,524,186), Tao (US Pat. 10,478,667), and Morelli et al. (US Pat. 8,443,806) are cited to show similar respiratory mask devices with exhalation valves and/or rotatable components of the valves.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785