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
This office action is responsive to the preliminary amendment filed 05/17/2023. As directed by the amendment, claims 4-5, 8-12, 15, and 18-19 were amended. Claims 1-19 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of claims 1-11 in the reply filed on 01/07/2026 is acknowledged.
Claim Objections
Claims 1-11 are objected to because of the following informalities. Appropriate correction is required.
Claim 1 limitation “a vent and AAV arrangement” are objected to, since the abbreviation “AAV” is not clearly defined in the claim. It appears that AAV refers to an anti-asphyxiation valve (based on [0069]). It is suggested to remove ambiguity by amending the limitation to recite “a vent and an anti-asphyxiation valve (AAV)”. Subsequent recitations of “AAV” are acceptable.
Claims 2-11 are objected to as depending upon an objected-to base claim.
Claim 11 limitation “RPT device” is objected to since abbreviation “RPT” is not clearly defined in the claim. It appears that “RPT” refers to a “respiratory therapy device” based on specification [0016]. It is suggested to remove ambiguity of the abbreviation in the claim by amending to recite “a respiratory therapy device (RPT)”.
Claim 1 is further objected to for the limitation in lines 5-6, which should be amended as follows: “a seal-forming structure configured to be constructed and arranged to form a seal with a region of a patient’s face…” to avoid the appearance of claiming a portion of the human body.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana et al. (US 2016/0129214 A1), hereafter Dantanarayana, in view of Huddart et al. (US 2016/0008558 A1), hereafter Huddart.
Dantanarayana discloses a patient interface (fig. 7, patient 50, mask shell 32 [0072]) to deliver a flow of air at a positive pressure with respect to ambient air pressure to an entrance to the patient's airways ([0003]) including at least the entrance of a patient's nares (fig. 7, the patient’s nose is covered by the mask [0072]) while the patient is sleeping, to ameliorate sleep disordered breathing ([0003] the invention was developed for sleep apnea), the patient interface comprising: a seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding the entrance to the patient's airways (fig. 7, seal is shown, but not labeled, surrounding and conforming to the patient’s nose), the seal-forming structure forming at least a portion of a plenum chamber pressurizable to a therapeutic pressure ([0074] therapeutic pressure is supplied to the mask shell 32); and a vent and AAV arrangement (fig. 7, flow regulation vent 10 [0074]) configured to regulate flow therethrough to (1) provide a vent flow path when pressure in the plenum chamber is above a predetermined magnitude ([0074] the arrangement allows gas to vent from the mask to the atmosphere) and (2) provide a breathable flow path when pressure in the plenum chamber is below the predetermined magnitude or not delivered ([0074] the vent acts as an anti-asphyxia valve to open when low or no pressure is provided), the vent and AAV arrangement comprising a shell portion (fig. 4 and fig. 7, base portion 30 [0072]) including a port extending therethrough (fig. 4, port 38 [0072]), the port configured to allow gas to flow between the plenum chamber and ambient ([0072]); an AAV member provided to the shell portion (fig. 4, the assembly of the vent 10 [0072]), the AAV member including a flap portion (figs. 4-5, flap portion indicated with 10 [0072]) structured and arranged to regulate flow through the port ([0076]), wherein the flap portion includes a plurality of vent holes therethrough (fig. 1, vent 10 has holes 22, 24, 26 [0071]), wherein the flap portion is movable to a deactivated position when pressure in the plenum chamber is above the predetermined magnitude to cover the port so that a vent flow of gas is allowed to pass along the vent flow path that extends through the plurality of vent holes of the flap portion and through the port ([0075]), and wherein the flap portion is movable to an activated position when pressure in the plenum chamber is below the predetermined magnitude or not delivered to uncover the port so that a breathable flow of gas is allowed to pass along the breathable flow path that extends through the port ([0074]),
The embodiment of figs. 1-11 is silent on a diffusing member.
However, Dantanarayana also discloses an embodiment of a ventilation valve (figs. 25-29 [0124]) which includes a diffusing member (fig. 27, 198 [0124]) provided to the shell portion (in the fig. 27 embodiment, shell portion is vent housing 154 [0124]), the diffusing member configured and arranged such that the port (in the embodiment of fig. 27, the port is passages 204 [0124]) is covered by the diffusing member so that at least a portion of the vent flow of gas passes into the diffusing member (fig. 27, diffuser 198 covers the vent orifices 160 since it spans the entire width of the housing 154 and at least a portion of flowing gas passes through the diffuser 198 out to orifices 160 [0124]); and a diffusing member cover (fig. 26, 172 [0125]) to retain the diffusing member to the shell portion ([0125]), the diffusing member cover including an anterior wall completely covering an anterior side of the diffusing member (fig. 27, the cover 172 completely covers the diffuser 198), wherein the diffusing member (198) and diffusing member cover (172) are supported in spaced relation from an outlet end of the port (fig. 27, 198 is spaced from an outlet end of the ports 204 by seating pads 202, and 172 is spaced by the walls of 154).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments of figs. 1-11 and 25-29 to include a diffusing member in the shell portion arranged as claimed, since Dantanarayana teaches that the use of a diffuser can distribute air flow more evenly on the flap of the valve ([0124]; alternative embodiments may be combined [0084]).
The now modified invention remains silent on the lateral opening between the shell portion and the diffusing member and diffusing member cover, and wherein at least a portion of the vent flow of gas passes into the diffusing member along the vent flow path and then is redirected laterally by the anterior wall to flow through the lateral opening to ambient (the housing 154 does not have a lateral opening; the gas flows in a straight direction through the housing).
Huddart teaches a mask vent design (fig. 13 [0114]) which uses an annulus cap (fig. 13 570 [0114]) arranged with a diffuser (fig. 15, fibrous media 566 [0120]) that reduces fluid velocity to reduce entrainment with ambient air. The arrangement of the annulus cap is such that there is a lateral opening between the shell portion (fig. 15, see annotated fig.) and the diffusing member (fig. 15, 566 [0120]) and diffusing member cover (fig. 15 570 [0115]), and wherein at least a portion of the vent flow of gas passes into the diffusing member along the vent flow path (fig. 15 {0120]) and then is redirected laterally by the anterior wall to flow through the lateral opening to ambient (fig. 13, [0115]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dantanarayana’s shell portion (whether in the round embodiment of figs. 1-11 or the rectangular embodiment of figs. 25-29) to include a lateral opening between the shell portion and the diffusing member and the diffusing member cover wherein at least a portion of the vent flow of gas passes into the diffusing member along the vent flow path and then is redirected laterally by the anterior wall of the diffusing member cover to flow through the lateral opening to ambient as taught by Huddart in order to further reduce sound created by the fluid flow (Huddart [0115]).
Regarding Claim 2, Dantanarayana discloses a patient interface according to claim 1, further comprising a shell (fig. 7, shell 32 [0072]) to support the seal-forming structure (see annotated fig. 7) and form at least a portion of the plenum chamber (fig. 7, the outline of the patient’s nose is shown within the plenum of the shell 32), wherein the shell portion of the vent and AAV arrangement is provided to the shell (fig. 7, shell portion 30 of the AAV assembly 10 is shown attached to the shell 32 [0072]).
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Regarding Claim 3, Dantanarayana discloses a patient interface according to claim 2, wherein the shell portion forms an integral, one piece molded construction with the shell ([0072] base portion 30 may be integral with the shell 32).
Regarding Claim 4, Dantanarayana discloses a patient interface according to claim 1, but is silent on wherein the diffusing member comprises a textile material.
However, Huddart teaches the use of a textile material for the diffuser ([0112] fibrous material 166 includes wool, cotton, etc.; this is a similar material to fibrous material 566 in fig. 15 [0120]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make Dantanarayana’s diffusing member from a textile material as taught by Huddart in order to provide a tortuous pathway for the flow exiting the plenum to reduce the velocity and thus reduce the entrainment of the surrounding air, thereby minimizing disturbance of a draft from the mask (Huddart [0119-0120]).
Regarding Claim 5, Dantanarayana discloses a patient interface according to claim 1, further comprising an AAV guard provided to the shell portion, the AAV guard forming a stop for the flap portion when in the activated position (examiner’s note: “AAV guard” is interpreted to mean a stopper for the flap portion based on original specification [0228]; fig. 4, floor with orifices 38 is provided instead of an open bottom in base 30 to prevent damage to the vent 10 [0072]).
Regarding Claim 6, Dantanarayana discloses a patient interface according to claim 5, wherein the AAV guard comprises a wall oriented at an angle to the shell portion (fig. 4, the floor with orifices 38 forms a zero degree angle with the shell portion 30).
Regarding Claim 8, Dantanarayana discloses a patient interface according to claim 1, wherein at least the flap portion comprises a plastic material ([0079]).
Regarding Claim 9, Dantanarayana discloses a patient interface according to claim 1, wherein the AAV member comprises a silicone material (claim 7, the flap portion of the AAV assembly is made of silicone).
Regarding Claim 11, Dantanarayana discloses a CPAP system for providing gas at positive pressure for respiratory therapy to a patient ([0003], [0023]), the CPAP system comprising: an RPT device configured to supply a flow of gas at a therapeutic pressure ([0074] a flow generator is used to supply pressurized air to the mask); the patient interface according to claim 1 (refer to claim 1 above); and an air delivery conduit (fig. 7, gas tube or conduit 34 [0072]) configured to pass the flow of gas at the therapeutic pressure from the RPT device to the patient interface ([0072]).
Claim 7 is rejected under 35 U.S.C. 103 as unpatentable over Dantanarayana and Huddart, further in view of Himes et al. (WO 2018/177794 A1), hereafter Himes.
Regarding Claim 7, Dantanarayana discloses a patient interface according to claim 6, but is silent on wherein the wall is a solid wall without any holes therethrough (Dantanarayana’s wall has orifices 38).
However, Himes teaches an arrangement of a patient interface with an anti-asphyxia valve (fig. 4, 30 [32]) which has a flap (fig. 5A, 46 [33]) and a AAV guard (fig. 5, 50 [33]) arranged in a configuration which permits air flow and the wall is solid without any holes therethrough (fig. 5A, [35]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace Dantanarayana’s AAV guard (floor with orifices 38, fig. 4) with the angled offset solid wall as taught by Himes, such that the floor with holes is instead the solid wall offset from the base portion (Dantanarayana fig. 4, 30) so that air may flow through the valve in the same manner as Hime’s valve configuration (Himes figs. 5A-B) in order to ensure that no portion of the patient’s face or facial features can block the gas flow through the apertures of the mask vent when pressure support is not being delivered (Himes [36]).
Claim 10 is rejected under 35 U.S.C. 103 as unpatentable over Dantanarayana and Huddart, further in view of Doshi et al. (US 2007/0277832 A1) hereafter Doshi.
Regarding Claim 10, Dantanarayana discloses a patient interface according to claim 1, but is silent on wherein the flap portion includes a textile vent or a microvent providing the plurality of vent holes.
Dantanarayana, however, discloses that the bleed orifices on the flap (fig. 1, 24, 26 [0071]) may be optimized in number and shapes may be altered to achieve a desired minimum bleed flow between the orifice 20 and the outer periphery of the flap (fig. 1, 10 [0078]). It has been held that where the general conditions of the claims are disclosed in the prior art, finding the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05.II.A). Optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over prior art (MPEP 2144.05).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the bleed orifices to be a microvent as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In the event that it is not obvious that Dantanarayana teaches to one of ordinary skill in the art that making the bleed orifices into a microvent to optimize the bleed flow, Doshi teaches a flap of a respiratory valve (figs. 9a-b [0150]) which may be made of a porous or filter (i.e., a textile) that is sufficiently stiff to withstand the forces of the respiratory process but also be able to filter debris, pollen, etc. without overly restricting airflow ([0154]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dantanarayana’s flap to include a textile vent or a microvent providing the plurality of vent holes, as taught by Doshi, in order to be able to filter debris without overly restricting airflow (Doshi [0154]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Copending Application No. 17/614919 (US publication 2022/0241536 A1) has been reviewed and the examiner has determined that there are patentably distinct differences between claim 1 of the instant application and claims 1, 2, and 5 of the co-pending application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785