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
The amendment filed 05/05/2026 has been entered. Claims 1-11 remain pending in the application. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed 02/06/2026.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11 have been considered but are moot because the new ground of rejection does not rely exclusively on the references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Please see below for the updated rejection in light of the amended claims changing the scope of the claimed subject matter by further defining the location of the AAV member and the flap portion.
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 1-9 and 11 are rejected under 35 U.S.C. 103 as unpatentable over Himes et al. (WO 2018/177794 A1), hereafter Himes, in view of Dantanarayana et al. (US 2016/0129214 A1), hereafter Dantanarayana, and further in view of Huddart (US 2016/0008558 A1), hereafter Huddart.
Regarding Claim 1, Himes discloses a patient interface to deliver a flow of air at a positive pressure with respect to ambient air pressure to an entrance to the patient's airways (fig. 1, pressure support system 2 [30]) including at least the entrance of a patient's nares ([30]) while the patient is sleeping, to ameliorate sleep disordered breathing ([06]), the patient interface comprising: a seal-forming structure configured to form a seal with a region of a patient's face surrounding the entrance to the patient's airways (fig. 1, 18 [30]), the seal-forming structure forming at least a portion of a plenum chamber (fig. 3, 20 [32]) pressurizable to a therapeutic pressure ([07], [30]); and a vent and anti-asphyxia valve (AAV) arrangement (fig. 2, 36 [32]) configured to regulate flow therethrough ([32]) to (1) provide a vent flow path when pressure in the plenum chamber is above a predetermined magnitude ([32]) and (2) provide a breathable flow path when pressure in the plenum chamber is below the predetermined magnitude or not delivered ([32]), the vent and AAV arrangement comprising: a shell portion (see annotated fig. 6 below) including a port extending therethrough (figs. 2 and 6, 32 [32]), the port configured to allow gas to flow between the plenum chamber and ambient ([32]); an anti-asphyxia valve (AAV) member (figs. 2 and 3, 42 [32]) provided to a posterior side of the shell portion (fig. 3, 42 is positioned on the posterior side of the shell [15]), the AAV member including a flap portion (fig. 5A, 46 [33]) configured and arranged to regulate flow through the port ([34]), wherein the flap portion is movable to a deactivated position when pressure in the plenum chamber is above the predetermined magnitude (fig. 5A [34]) to cover an inlet end of the port (fig. 5A, 46 is covering 32), 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 inlet end of the port so that a breathable flow of gas is allowed to pass along the breathable flow path that extends through the port (fig. 5B [34]).
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Himes is silent on wherein the flap portion includes a plurality of vent holes therethrough, the deactivated position of the flap portion covering an inlet end of 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, and a diffusing member as claimed.
Dantanarayana teaches an anti-asphyxiation valve arrangement having a flap portion (fig. 4, 10 [0071]) which has a plurality of vent holes therethrough (fig. 1, 26, 24 [0071]) so that the deactivation position of the flap portion covering an inlet end of a port ([0074]) so that a vent flow of gas is allowed to pass along a vent flow path that extends through the plurality of vent holes of the flap portion and through the port ([0078] the bleed holes allow for a desired bleed flow).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Himes’s flap portion as taught by Dantanarayana to include vent holes in order to allow a desired bleed flow through the mask (Dantanarayana [0078]).
Huddart discloses a diffusing member (fig. 15, diffuser 566 [0120]) provided to an anterior side of the shell portion (this configuration is shown positioned on a mask in fig. 13, [0114]), the diffusing member configured and arranged such that the port is covered by the diffusing member so that at least a portion of the vent flow of gas passes into the diffusing member (fig. 15 shows a port opening labeled with 514 [0115]); and a diffusing member cover to retain the diffusing member to the anterior side of the shell portion (fig. 15, 570 [0114]), the diffusing member cover including an anterior wall completely covering an anterior side of the diffusing member (fig. 15 shows this configuration), wherein the diffusing member and diffusing member cover are supported in spaced relation from an outlet end of the port to form a lateral opening between the shell portion and the diffusing member and diffusing member cover (fig. 15 shows the diffuser 566 and cover 570 spaced from the opening 514 and arrows indicate lateral movement of gas [0115]), 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 (fig. 15 [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 include a diffusing member in the configuration taught by Huddart on the anterior side of the mask in order to provide a tortuous path for fluid to pass through to reduce entrainment of the surrounding air (Huddart [0120]).
Regarding Claim 2, Himes discloses a patient interface according to claim 1, further comprising a shell to support the seal-forming structure (fig. 3, 16 [30]) and form at least a portion of the plenum chamber (fig. 3, 20 [31]), wherein the shell portion of the vent and AAV arrangement is provided to the shell (fig. 3).
Regarding Claim 3, Himes discloses a patient interface according to claim 2, but does not explicitly disclose wherein the shell portion forms an integral, one piece molded construction with the shell.
However, it has been held that making components into a single unit construction would have been a matter of obvious engineering choice, absent persuasive evidence that making components integral has a significant effect (see MPEP 2144.04(V)(B) In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the shell portion and the shell an integral, one piece molded construction.
Regarding Claim 4, the modified Himes discloses a patient interface according to claim 1, wherein the diffusing member comprises a textile material (Huddart, the diffuser is a textile material [0112] fibrous material 166 includes wool, cotton, etc.; this is a similar material to fibrous material 566 in fig. 15 [0120]).
Regarding Claim 5, Himes discloses a patient interface according to claim 1, further comprising an anti-asphyxia valve (AAV) guard provided to the shell portion, the AAV guard forming a stop for the flap portion when in the activated position (Himes figs. 5A-B, 50 [33]).
Regarding Claim 6, Himes discloses a patient interface according to claim 5, wherein the AAV guard comprises a wall oriented at an angle to the shell portion (Himes figs. 5A-B show that 50 is positioned at an angle to the shell portion indicated in the annotated fig. above; see also fig. 7A).
Regarding Claim 7, Himes discloses a patient interface according to claim 6, wherein the wall is a solid wall without any holes therethrough (Himes figs. 5A-B show this configuration).
Regarding Claim 8, Himes discloses a patient interface according to claim 1, but is silent on wherein at least the flap portion comprises a plastic material (no material is disclosed for 46).
However, Dantanarayana discloses a similar anti-asphyxiation valve flap made from plastic ([0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose plastic as the material for Himes’s flap portion, since plastic is a known material that provides the desired combination of rigidity, flexibility, and springiness needed for such a structure (Dantanarayana [0079]).
Regarding Claim 9, Himes discloses a patient interface according to claim 1, wherein the AAV member comprises a silicone material ([33] top of page 9).
Regarding Claim 11, Himes discloses a continuous positive airway pressure (CPAP) system for providing gas at positive pressure for respiratory therapy to a patient ([06]), the CPAP system comprising: a respiratory pressure therapy (RPT) device configured to supply a flow of gas at a therapeutic pressure (fig. 1, 4 [31]); the patient interface according to claim 1 (see claim 1 above, as modified); and an air delivery conduit configured to pass the flow of gas at the therapeutic pressure from the RPT device to the patient interface (fig. 1, 6 [31]).
Claim 10 is rejected under 35 U.S.C. 103 as unpatentable over Himes, Dantanarayana, and Huddart, further in view of Doshi et al. (US 2007/0277832 A1).
Regarding Claim 10, Himes 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.
Stephenson et al. (US 2017/00657896 A1 ) discloses a diffusing member (figs. 1-3, vent 12 covered by diffusing member 42 [0083]) provided to an anterior side of the shell portion (this configuration is shown in figs. 1-3), the diffusing member configured and arranged such that the port is covered by the diffusing member so that at least a portion of the vent flow of gas passes into the diffusing member ([0082]); and a diffusing member cover to retain the diffusing member to the anterior side of the shell portion (fig. 6, 46 [0086] and [0088]), the diffusing member cover including an anterior wall completely covering an anterior side of the diffusing member (fig. 6 shows this configuration), wherein the diffusing member and diffusing member cover are supported in spaced relation from an outlet end of the port to form a lateral opening between the shell portion and the diffusing member and diffusing member cover (fig. 6, second wall portion 48 can be adjacent to the vent 12; 48 is understood to be a set of walls that are hollow through the center to allow the flow of gases through diffuser 42, thus creating a spaced region between a port in the shell).
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 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
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