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
In light of amendments filed December 18, 2025, drawings received on July 24, 2024, are acceptable.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2-5, 8-10, 12-14 and 16-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US2015/0068519 (“Bambrilla”).
Regarding claim 2, Bambrilla discloses (see fig. 10) a constant flow valve flow valve (112), comprising:
a body (mainly defined by 146 and 22) defining a passageway (passageway connecting pumped air via inlet 36 to mask via connection of members 146 and 16; see figs. 1 and 10) for a gases flow to a patient (via mask 10), the body defining an interior surface (cylindrical interior surface defined by body members 22 and 146);
one or more ports (150) through the body to provide fluid communication between the passageway and an outside environment (atmosphere exterior to adaptor 112); and
an internal valve member (152) attached to the body relative to the interior surface of the body, wherein the internal valve member defines a side surface (radially outer surface of member 152) facing the interior surface of the body and an edge (left edge, relative to the orientation of fig. 10) facing a direction of the gases flow (flow extending along longitudinal axis of air inlet port 36), wherein the internal valve member is flexible to allow the side surface to move towards and away from the interior surface such that the valve member defines
a closed configuration (configuration where flexible valve member 152 is expanded towards ports 150; see specification paragraph [0050]) in which the gases flow through the one or more ports is restricted when a gas pressure (gas pressure regulated by pumped air entering port 36) in the constant flow valve is above a threshold pressure (pressure necessary to fully occlude ports 150); and
an open configuration (see normal position illustrated in fig. 10) that allows gas the gases flow to pass from the passageway to the outside environment with less restriction than the closed configuration when the gas pressure in the constant flow valve is at or below a threshold pressure (any pressure below the pressure value necessary to maintain ports 150 occluded), wherein the side surface of the internal valve member moves in a direction (internal valve member 152 flexes in a radial direction relative to a longitudinal axis of inlet port 36) that is perpendicular to the direction of gases flow through the constant flow valve between the closed configuration and the open configuration.
Regarding claim 3, Bambrilla discloses the internal valve member (152) is configured to progressively occlude (conical shape of internal valve member 152 causes right side of the member 152, relative to the orientation of fig. 10, to contact the internal surface before the left side of member 152, relative to the orientation of fig. 10, due to the amount of tensioning force required to stretch the member 152 to fully expand) the one or more ports (150).
Regarding claim 4, Bambrilla discloses the internal valve member (152) is configured to progressively move toward the interior surface (conical shape of internal valve member 152 causes right side of the member 152, relative to the orientation of fig. 10, to contact the internal surface before the left side of member 152, relative to the orientation of fig. 10, due to the amount of tensioning force required to stretch the member 152 to fully expand) from the open configuration (position of internal valve member 152 illustrated in fig. 10) to the closed configuration (see specification paragraph [0050]).
Regarding claim 5, Bambrilla discloses the internal valve member (152) is configured to flex away from the interior surface in a radial direction (radially inward direction, away from ports 150) from the closed configuration (configuration where flexible valve member 152 is expanded towards ports 150; see specification paragraph [0050]) to the open configuration (configuration illustrated in fig. 10) to allow gas to pass from the passageway (passageway connecting pumped air via inlet 36 to mask via connection of members 146 and 16; see figs. 1 and 10) to the outside environment under pressure conditions at or below the threshold pressure (pressure required to fully expand valve member 152 to occlude ports 150).
Regarding claim 8, Bambrilla discloses the internal valve member (152) is configured to flex towards the body (mainly defined by 146 and 22) to occlude the one or more ports (150) at a lower gas flow rate through the passageway in which the gas pressure is above the threshold pressure (valve member 152 reacts to differential pressure between fluid pressure at a radial center of the valve member 152 and a radial exterior of the valve member 152; although pressure across the valve member is sometimes associated with the gas flow rate therethrough, reaction of the valve member between open and closed positions is resultant of the pressure difference across the radially inner surface and radially outer surface of the valve member 152).
Regarding claim 9, Bambrilla discloses the body (mainly defined by 146 and 22) is a round or oval tube (see fig. 2 and fig. 10).
Regarding claim 10, Bambrilla discloses the internal valve member (152) extends around at least part of an inner circumference (see fig. 10) of the body (mainly defined by 22 and 146).
Regarding claim 12, Bambrilla discloses the interior surface (cylindrical interior surface defined by body members 22 and 146) being curved.
Regarding claim 13, Bambrilla discloses the constant flow valve (112) is configured to be placed at an inlet (16) of a patient interface (mask, 10).
Regarding claim 14, Bambrilla discloses the constant flow valve (112) is configured to be placed in-line between a patient interface (mask 10) and a blower(“jet pump”; see specification paragraph [0048]).
Regarding claim 16, Bambrilla discloses (see fig. 10) a valve (112) for use in positive airway pressure therapy, comprising:
a tubular body (mainly defined by 146 and 22) that defines a passageway (passageway connecting pumped air via inlet 36 to mask via connection of members 146 and 16; see figs. 1 and 10) for a gases flow through the valve in a direction (leftward direction, relative to the orientation of fig. 10) towards a patient (via mask 10), the body comprising an interior surface (cylindrical interior surface defined by body members 22 and 146) that surrounds a longitudinal axis of the body;
one or more ports (150) through the body to provide fluid communication between the passageway and an outside environment (atmosphere exterior to adaptor 112);
a flexible valve member (152) attached to the body within the passageway, the valve member having a side surface (radially outer surface of member 152) that faces the interior surface and an edge (left edge, relative to the orientation of fig. 10) that faces the direction of the gases flow, wherein a flow area (area allowing flow from left end of housing part 146, relative to the orientation of fig. 10, toward ports 150; see fig. 10) is defined between the side surface and the interior surface, wherein the flow area is perpendicular to the direction of the gases flow (flow extending through ports 150 exhausts in a perpendicular direction to a longitudinal direction of housing, 22 & 146), and wherein the gases flow passes through the flow area to exit the passageway through the one or more ports;
wherein the valve member is responsive to an increase in a gas pressure (via pumped air entering inlet 38) within the valve such that the side surface of the valve member moves from a first configuration (open configuration illustrated in fig. 10) towards the interior surface to a second configuration (configuration where flexible valve member 152 is expanded towards ports 150; see specification paragraph [0050]) to reduce a size of the flow area and restrict the gases flow through the one or more ports.
Regarding claim 17, Bambrilla discloses the side surface (radially outer surface of member 152) of the valve member moves progressively toward (conical shape of internal valve member 152 causes right side of the member 152, relative to the orientation of fig. 10, to contact the internal surface before the left side of member 152, relative to the orientation of fig. 10, due to the amount of tensioning force required to stretch the member 152 to fully expand) the interior surface (cylindrical interior surface defined by body members 22 and 146) from the first configuration (open configuration illustrated in fig. 10) to the second configuration (configuration where flexible valve member 152 is expanded towards ports 150; see specification paragraph [0050]).
Regarding claim 18, Bambrilla discloses the valve member (152) moves in a radial direction (radial direction relative to a radius of valve member 152 and body parts, 22 and 146) between the first configuration (open configuration illustrated in fig. 10) and the second configuration (configuration where flexible valve member 152 is expanded towards ports 150; see specification paragraph [0050]).
Regarding claim 19, Bambrilla discloses the valve member (152) forms a closed loop (conically shaped loop).
Regarding claim 20, Bambrilla discloses the interior surface (cylindrical interior surface defined by body members 22 and 146) is curved.
Regarding claim 21, Bambrilla discloses the valve (112) is configured to be placed in-line between a patient interface (mask, 10) and a blower (“jet pump”; see specification paragraph [0048]).
Claim 2 is rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US2014/0305431 (“Holley”).
Regarding claim 2, Holley discloses a constant flow valve flow valve (see figs. 26-31), comprising:
a body (2609) defining a passageway (“CA” and/or “CB”) for a gases flow to a patient (via user end 2609UE), the body defining an interior surface (interior surface of conduit 2609);
one or more ports (see venting apertures extending through venting portion 2611) through the body to provide fluid communication between the passageway and an outside environment (environment exterior to conduit 2609); and
an internal valve member (2607) attached to the body relative to the interior surface of the body, wherein the internal valve member defines a side surface (upper surface, relative to the orientation of fig. 26) facing the interior surface of the body and an edge (“FE” or “LE”) facing a direction (flow along conduit 2609) of the gases flow, wherein the internal valve member is flexible to allow the side surface to move towards (see figs. 28 and 29) and away (see figs. 26, 27, 30 and 31) from the interior surface such that the valve member defines
a closed configuration (see figs. 28 and 29) that occludes in which the gases flow through the one or more ports is restricted when a gas pressure (from air/gas supply end 2609ASE) in the constant flow valve is above a threshold pressure (pressure caused by inspiratory flow “IF”); and
an open configuration (see figs. 26 and 27) that allows gas the gases flow to pass from the passageway (“CA” and/or “CB”) to the outside environment with less restriction than the closed configuration when the gas pressure in the constant flow valve is at or below a threshold pressure (see specification paragraph ]0144]), wherein the at least one flap side surface of the internal valve member moves in a direction that is perpendicular (valve member 2607 flexes radially inwardly, relative to a radius of the body 2609) to the direction of gases flow through the constant flow valve between the closed configuration (see fig. 28) and the open configuration (see figs. 26 and/or 30).
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.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Holley, as applied to claim 2 above, in view of US6883518 ("Mittelstadt").
Regarding claim 11, Holley discloses the at least one flap (2607) coupled to the body (2609); however, Holley does not disclose the at least one flap being coupled to the body by posts that extend through the body.
Mittelstadt teaches coupling a flap (56) to a body (50) by posts (80) that extend through the body.
It would have been obvious to one having ordinary skill in the art at the time of filing of the invention to modify the invention of Holley by coupling the at least one flap to the body by posts that extend through the body, as taught by Mittelstadt, to be able to remove the at least one flap for maintenance.
Claims 15 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Brambilla, as applied to claims 2 and 16 above, in view of US2004/0094157 (“Dantanarayana”).
Regarding claims 15 and 22, Brambilla discloses the internal valve member (152) transitioning between the open, or first, configuration (see open configuration illustrated in fig. 10) and the closed, or second, configuration where flexible valve member 152 is expanded towards ports 150; see specification paragraph [0050]) during a range of pressures (range of pressures where vale member 152 may flex away from rested position).
Brambilla is silent to the range of pressures being at least approximately 1.5 cm H20 1.5 cm H20 and/or less than or equal to approximately 4 cm H20.
However, Dantanarayana teaches an internal valve member (12) transitioning between an open configuration and a closed configuration during a range of pressures wherein the range of pressures is at least approximately 1.5 cm H20 and/or less than or equal to approximately 4 cm H20 (see specification paragraphs [0073]).
It would have been obvious to one having ordinary skill in the art at the time of filing of the invention to modify the invention of Brambilla by configuring the range of pressures to be at least approximately 1.5 cm H20 and/or less than or equal to approximately 4 cm H20, as taught by Dantanarayana, to allow exhaustion of gases at an operation flow and/or pressure.
Response to Arguments
Applicant’s arguments filed December 18, 2025, have been fully considered.
With regards to the objections to the drawings and specification set forth in the Office action dated August 26, 2025, in light of the amended claims filed December 18, 2025, the objection(s) to the drawings and specification are now withdrawn.
With regards to the 35 U.S.C. 112(a) rejection of claims 2-15 and the 35 U.S.C. 112(b) rejection of claims 5-8, in light of the amended claims filed December 18, 2025, these rejections are now withdrawn.
With regards to the prior art rejection of claims 2-10 and 12-15 over Dantanarayana, and claim 11 over Dantanarayana in view of Mittelstadt, Applicant’s amendment has overcome the rejection of record. However, the amended claims have necessitated new ground(s) of rejection rendering Applicant's arguments regarding Dantanarayana, including further combinations thereof, are moot.
Conclusion
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 Hailey K. Do whose direct telephone number is (571)270-3458 and direct fax number is (571)270-4458. The examiner can normally be reached on Monday-Thursday (8:00AM-5:00PM ET) and Friday (8:00AM-12:00PM ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisors, Kenneth Rinehart at 571-272-4881, or Craig M. Schneider at 571-272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAILEY K. DO/Primary Examiner, Art Unit 3753