DETAILED ACTION
This Office Action is in response to the filing of the application on 1/19/2023. Since the initial filing, no claims have been amended, added, or cancelled. Thus, claims 1-20 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 Fig. 5 fails to comply with 37 CFR 1.84(h)(1) whereby an exploded view should be embraced by a bracket to show the connective relationship between the 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because line 1 contains the language “The present disclosure provides” which is an implied phrase and should be removed. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 1-2, 4-5, 7-9, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Penton et al. (US Pat. 7,866,319) in view of Bailey et al. (US Pat. 5,103,854) in view of Ulmann (US Pat. 3,474,783).
Regarding claim 1, Penton discloses a valve for a respiratory mask (valve system of Fig. 4, see also Col. 4 line 65 to Col. 5 line 1), the valve comprising: a valve housing (see Fig. 4, main body 20, rear wall 34, rear wall 76, and cover 90) comprising a valve seat (see Fig. 4 valve seat 35) and an inlet (see Fig. 4 rear opening 36); a valve flap at least partially received within the valve housing (see Fig. 4 positive pressure valve 140, which is the flap part of positive pressure valve assembly 130), wherein the valve flap is sealingly engaged with the valve seat in a closed configuration (see Fig. 4 and Col. 8 lines 40-59 where the valve 140 has a closed configuration that seals against valve seat 35) and is disengaged from the valve seat in a plurality of open configurations (see Fig. 4, Col. 8 lines 40-59 and where a first open position comes from pressure moving the peripheral skirt 146 away from the valve seat 35 so that the air can pass by the valve flap, and a second open position is shown in Fig. 4 where the valve assembly 140 is pulled away from valve seat 35 by rotation of outer cover 90, resulting in a second, more open position), the valve flap comprising a tubular projection extending away from the valve seat along a longitudinal axis (see Fig. 4 where boss 142 is a tubular projection that extends in the longitudinal axis, and away from the valve seat 35), the plurality of open configurations comprising a first open configuration and a second open configuration (see Fig. 4, Col. 8 lines 40-59 and where a first open position comes from pressure moving the peripheral skirt 146 away from the valve seat 35 so that the air can pass by the valve flap, and a second open position is shown in Fig. 4 where the valve assembly 140 is pulled away from valve seat 35 by rotation of outer cover 90, resulting in a second, more open position); a pin slidably received through the valve housing and coupled to the tubular projection (see Fig. 4 central shaft 132, coupled to the valve assembly 140), wherein the pin and the valve flap are together movable along the longitudinal axis relative to the valve seat (see fig. 4 and Col. 8 lines 27-59 where the central shaft 132 is axially slidable (see the motion that occurs between Figs. 9 and 10)); a valve cage coupled to the valve housing (see Fig. 4 annular body 42, peripheral wall 62); a central limiter coupled to the valve cage and extending towards the tubular projection along the longitudinal axis (see Fig. 4 central hub 44, which is centrally located, along the longitudinal axis, limiting the axial motion of the valve assembly 140, and extending in a direction towards the boss 142); a cap disposed on the valve flap opposite to the valve seat (see Fig. 4 backing plate 150, where it is understood that a cap can be defined as something that serves as a cover or protection (as per Merriam-Webster’s online dictionary, as accessed on 12/12/2025)), wherein the cap is engaged with the valve flap and movable along the longitudinal axis (see the motion of Fig. 9 to Fig. 10, and Col. 8 lines 27-59 where the backing plate 150 moves with the valve 130 and shaft 132); and a biasing member disposed between and engaged with the cap and the valve cage (see Fig. 4 biasing member 156), the biasing member configured to normally bias, via the cap, the valve flap to the closed configuration (see Col. 6 lines 42-49 where the biasing member 156 pushes the valve 140 onto away from valve seat 40 and thus towards valve seat 35, forming the closed configuration (as seen in Fig. 1)); wherein, in response to an inlet pressure at the inlet of the valve housing, the valve flap moves linearly, along the longitudinal axis (see Fig. 11 and Col. 8 lines 50-59 where, from a position where the valve 140 is against the valve seat 35, a positive inlet pressure is able to push the valve assembly 140 and shaft 132 linearly away from valve seat 35 to create an opening), from the closed configuration to the first open configuration against the biasing of the biasing member (see Figs. 10-11 and Col. 8 lines 50-59 where, from a position where the valve 140 is against the valve seat 35, the valve assembly 140 and shaft 132 move linearly against the force of the biasing member 156), wherein the linear movement of the valve flap from the closed configuration to the first open configuration causes a corresponding linear movement of the cap along the longitudinal axis (see Figs. 10-11 and Col. 8 lines 50-59 where motion of the valve 140 and shaft 132 from the closed to an 80open configuration includes the linear motion of the backing plate 150, which is affixed to the valve 140 and shaft 132).
Penton lacks a detailed description of wherein, in the first open configuration of the valve flap, the central limiter engages with the tubular projection to prevent further movement of the tubular projection along the longitudinal axis.
However, Bailey teaches a pressure valve for respiratory use, where in a first open configuration of the valve flap, the limiter engages with the valve assembly to prevent further movement of the valve assembly along the longitudinal axis (see Figs. 2-3 where the motion of the disk 48 from the bead portion 36 of the rim 22 is a motion along a longitudinal axis in response to a pressure, resulting in an open configuration. The displacement of the disk 48 is stopped by stops 80 (which can be a centrally located stop as seen in Col. 4 lines 58-63).
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 first open configuration of Penton to reach and stop due to the centrally located stop, as taught by Bailey, as it would allow for the valve to still open and close in response to changing pressure/ biasing forces, while limiting the movement to better prevent damage to the flexible elements and ensure that fluid can flow freely over the upper surface thereof (Bailey; see Col. 5 lines 25-32).
The modified Penton device lacks a detailed description of the valve flap transitioning, in response to the inlet pressure, from the first open configuration to the second open configuration in order to remain disengaged from the valve seat, and wherein the valve flap at least partially deforms to transition from the first open configuration to the second open configuration.
However, Ulmann teaches a valve system for a respiratory device, where a valve flap is able to transition from a first open configuration to a second open configuration in response to increased inlet pressure, resulting from a deformation of the valve flap from the first to second open configuration (see Figs. 2-3, where diaphragm 32 has a first open position (see Figs. 2-3 and 5; and Col. 3 lines 1-7 where the diaphragm sitting on the valve seat 22 is able to have slight movement/ deformation to allow for the passage of air in a low-pressure setting) and a second open position (see Fig. 3 and Col. 3 lines 62-65 where the diaphragm 32 has a second open position, where it deforms greatly under higher pressure to allow for greater flow rates)).
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 valve flap of the modified Penton device to be able to deform from its first to a second open configuration as taught by Ulmann, as it would allow for the valve to be adjustable in response to a change from a low pressure to a high pressure usage, ensuring the valve system is applicable to a wide range of respiratory applications.
Regarding claim 2, the modified Penton device has wherein the valve flap is made of a deformable material (Penton; see Fig. 4 where valve 130, as modified by Ulmann, is made of a material that deforms).
Regarding claim 4, the modified Penton device has wherein the cap is made of a rigid material having an elastic modulus greater than an elastic modulus of the deformable material of the valve flap (Penton; see Col. 7 lines 1-7 where the backing plate 150 is made of PBT to be more rigid than the modified positive pressure valve 140 made of a flexible material such as silicone), such that the engagement between the cap and the valve flap causes the valve flap to at least partially deform in order to transition from the first open configuration to the second open configuration (Penton; see Fig. 4 where the pressure valve 130, as modified by Ulmann, abuts the backing plate 150, such that they are engaged with one another, and the outer peripheral rim of the valve flap deforms in response to pressure to go from the first open to second open configuration as taught by Ulman (see Fig. 3 and Col. 3 lines 62-65)).
Regarding claim 5, the modified Penton device has a sealing ring (Penton; see compression clamp 184 in Fig. 4), wherein the valve housing comprises a groove at least partially receiving the sealing ring therein (Penton; see Fig. 4 where a groove formed under circumferential flange 26 of the main body 20 at least partially receives the compression clamp 184), such that the sealing ring seals the valve against a body of the respiratory mask (Penton; see Col. 7 lines 25-32).
Regarding claim 7, the modified Penton device has wherein the cap comprises: an inner aperture therethrough (Penton; see Fig. 4 where the backing plate 150 has a central aperture through which the shaft 132 and circumferential groove 148 of boss 142 fit), the inner aperture defining an inner diameter of the cap and configured to at least partially receive the tubular projection therethrough (Penton; see Fig. 4 where the inner space of the backing plate 150 at least partially holds and receives the boss 142), and an annular shoulder surrounding the inner aperture, wherein the annular shoulder engages with the biasing member (Penton; see Fig. 4 where an upper part of the biasing member 156 contacts a shoulder groove at the base of the central hub 44, which circumferentially surrounds the inner aperture of the backing plate 150).
The modified Penton device lacks a detailed description of wherein the inner diameter of the cap is greater than a maximum width of the central limiter.
However, Bailey further teaches where the central limiter has a smaller width than the diameter of a cap member (see Fig. 2 where hub 24 acts as a supporting cap member to disk 48, such that stop members 80 are shown to be smaller in size than the hub 24).
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 central hub stop member of the modified Penton device to be smaller in width than the aperture of the cap as taught by Bailey, as it would be a simple substitution of one size of stop member for another, to yield the predictable result of providing a stop member that extends out and stops axial movement of the valve.
Regarding claim 8, the modified Penton device has wherein, in response to the inlet pressure, at least a portion of the valve flap deforms and moves non-linearly during the transition of the valve flap from the first open configuration to the second open configuration (Ulmann; see Figs. 2-3, where diaphragm 32 has a first open position (see Figs. 2-3 and 5; and Col. 3 lines 1-7 where the diaphragm sitting on the valve seat 22 is able to have slight movement/ deformation to allow for the passage of air in a low-pressure setting) and a second open position (see Fig. 3 and Col. 3 lines 62-65 where the diaphragm 32 has a second open position, where it deforms greatly under higher pressure to allow for greater flow rates), such that the deformation of the diaphragm is a non-linear motion at the outer peripheral edges have much larger displacement than the center of the diaphragm), thereby causing a further movement of the cap, along the longitudinal axis, towards the central limiter (Penton; see Fig. 4, Col. 8 lines 40-59 and where a first open position comes from pressure moving the peripheral skirt 146 away from the valve seat 35 so that the air can pass by the valve flap, thus moving the valve assembly 130 and backing plate towards the central hub 44).
Regarding claim 9, the modified Penton device has wherein the valve housing further comprises a tubular sleeve configured to at least partially and slidably receive the pin therethrough (Penton; see Fig. 4 where central opening 78 of rear wall 76 of the valve housing form a tubular sleeve through which the shaft 132 travels).
Regarding claim 18, Penton discloses a valve for a respiratory mask (valve system of Fig. 4, see also Col. 4 line 65 to Col. 5 line 1), the valve comprising: a valve flap configured to prevent fluid flow through the valve in a closed configuration (see Fig. 4 positive pressure valve 140, which is the flap part of positive pressure valve assembly 130, which can be closed as in Fig. 10), wherein the valve flap is further configured to allow fluid flow through the valve in each of a first open configuration and a second open configuration (see Fig. 4, Col. 8 lines 40-59 and where a first open position comes from pressure moving the peripheral skirt 146 away from the valve seat 35 so that the air can pass by the valve flap, and a second open position is shown in Fig. 4 where the valve assembly 140 is pulled away from valve seat 35 by rotation of outer cover 90, resulting in a second, more open position), the valve flap comprising a tubular projection extending along a longitudinal axis (see Fig. 4 where boss 142 is a tubular projection that extends in the longitudinal axis, and away from the valve seat 35); a central limiter extending towards the tubular projection along the longitudinal axis (see Fig. 4 central hub 44, which is centrally located, along the longitudinal axis, limiting the axial motion of the valve assembly 140, and extending in a direction towards the boss 142), wherein the central limiter is stationary within the valve (see Fig. 4 where central hub 44 does not move relative to the valve); a biasing member configured to normally bias the valve flap to the closed configuration (see Col. 6 lines 42-49 where the biasing member 156 pushes the valve 140 onto away from valve seat 40 and thus towards valve seat 35, forming the closed configuration (as seen in Fig. 1)); wherein, in response to an inlet pressure applied on the valve, the valve flap moves linearly, along the longitudinal axis (see Fig. 11 and Col. 8 lines 50-59 where, from a position where the valve 140 is against the valve seat 35, a positive inlet pressure is able to push the valve assembly 140 and shaft 132 linearly away from valve seat 35 to create an opening), from the closed configuration to the first open configuration against the biasing of the biasing member (see Figs. 10-11 and Col. 8 lines 50-59 where, from a position where the valve 140 is against the valve seat 35, the valve assembly 140 and shaft 132 move linearly against the force of the biasing member 156).
Penton lacks a detailed description of wherein, in the first open configuration of the valve flap, the central limiter engages with the tubular projection to prevent further movement of the tubular projection along the longitudinal axis.
However, Bailey teaches a pressure valve for respiratory use, where in a first open configuration of the valve flap, the limiter engages with the valve assembly to prevent further movement of the valve assembly along the longitudinal axis (see Figs. 2-3 where the motion of the disk 48 from the bead portion 36 of the rim 22 is a motion along a longitudinal axis in response to a pressure, resulting in an open configuration. The displacement of the disk 48 is stopped by stops 80 (which can be a centrally located stop as seen in Col. 4 lines 58-63).
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 first open configuration of Penton to reach and stop due to the centrally located stop, as taught by Bailey, as it would allow for the valve to still open and close in response to changing pressure/ biasing forces, while limiting the movement to better prevent damage to the flexible elements and ensure that fluid can flow freely over the upper surface thereof (Bailey; see Col. 5 lines 25-32).
The modified Penton device lacks a detailed description of the valve flap transitioning, in response to the inlet pressure, from the first open configuration to the second open configuration in order to remain disengaged from the valve seat, and wherein the valve flap at least partially deforms non-linearly to transition from the first open configuration to the second open configuration, such that an excitation frequency of the valve due to the inlet pressure changes and becomes different from a natural frequency of the valve.
However, Ulmann teaches a valve system for a respiratory device, where a valve flap is able to transition from a first open configuration to a second open configuration in response to increased inlet pressure, resulting from a deformation of the valve flap from the first to second open configuration (see Figs. 2-3, where diaphragm 32 has a first open position (see Figs. 2-3 and 5; and Col. 3 lines 1-7 where the diaphragm sitting on the valve seat 22 is able to have slight movement/ deformation to allow for the passage of air in a low-pressure setting) and a second open position (see Fig. 3 and Col. 3 lines 62-65 where the diaphragm 32 has a second open position, where it deforms greatly under higher pressure to allow for greater flow rates, and the deformation shown in non-linear as the peripheral edges have a much greater displacement)) such that an excitation frequency of the valve due to the inlet pressure changes and becomes different from a natural frequency of the valve (see Col. 3 lines 62-65 and Fig. 3 where the change in shape of the diaphragm is understood to allow it to work under different flow rates, and the shape change would result in changes to the physical properties and resistance of the diaphragm such that the frequency is different from the first and second open positions).
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 valve flap of the modified Penton device to be able to deform from its first to a second open configuration as taught by Ulmann, as it would allow for the valve to be adjustable in response to a change from a low pressure to a high pressure usage, ensuring the valve system is applicable to a wide range of respiratory applications.
Regarding claim 19, the modified Penton device has a valve housing comprising a valve seat (Penton; see Fig. 4 valve seat 35) and an inlet (Penton; see Fig. 4 rear opening 36), wherein, in the closed configuration, the valve flap is sealingly engaged with the valve seat (Penton; see Fig. 10 where valve 140 is sealed against the valve seat 35), wherein, in each of the first open configuration and the second open configuration, the valve flap is disengaged from the valve seat (Penton; see Fig. 4, Col. 8 lines 40-59 and where a first open position comes from pressure moving the peripheral skirt 146 away from the valve seat 35 so that the air can pass by the valve flap, and a second open position is shown in Fig. 4 where the valve assembly 140 is pulled away from valve seat 35 by rotation of outer cover 90, resulting in a second, more open position), and wherein the inlet pressure is applied at the inlet due to fluid flow (Penton; see Fig. 4 inlet 36; see also Col. 9 line 49 to Col 10 line 20, describing operation of the valve where, when the positive pressure valve 140 is in active use, it is in an open configuration that allows fluid to pass through the inlet from the user).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Penton in view of Bailey in view of Ulmann as applied to claim 2 above, and further in view of Christianson (US Pat. 4,862,884).
Regarding claim 3, the modified Penton device has wherein the valve flap is a deformable material.
The modified Penton device lacks a detailed description of wherein the deformable material is an elastomer.
However, Christianson teaches a valve system for a respiratory device, where a deformable valve flap is made of an elastomer (see Col. 5 lines 8-17).
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 deformable material of the valve flap of the modified Penton device to be an elastomer as taught by Christianson, as it would be a simple substitution of one type of deformable material for another, to yield the predictable result of letting the valve flap deform due to a pressure to operate the valve.
Claims 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Penton in view of Bailey in view of Ulmann as applied to claims 1 and 18 above, respectively, and further in view of Nitta (US Pub. 2015/0101610).
Regarding claims 6 and 20, the modified Penton device has wherein, in the closed configuration of the valve flap, there is a minimum distance between the central limiter and the tubular projection of the valve flap.
The modified Penton device lacks a detailed description of the minimum distance between the central limiter and the tubular projection of the valve flap is between 4 mm and 6 mm.
However, Nitta teaches a respiratory device using a valve, where the displacement stroke of a valve is in the range of 2-3 mm (see [0045]).
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 distance between the central limiter and tubular projection, which is the displacement stroke of the valve, of the modified Penton device to be about 4 mm, as taught by Nitta, as it would provide a small displacement stroke distance that is consistent with the size of an exhalation valve for a respiratory mask. The specific distance of 4 to 6 mm lacks criticality, and as such as person of ordinary skill in the art, upon seeing a distance of 3 mm, would be able to make an obvious design choice to alter to the distance to other close measurements, such as 4 mm. Furthermore, the specification appears to note that the distance can be within this range (see page 15 lines 1-4, where an example distance is 2.5 mm).
Claims 10-12 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Penton in view of Bailey in view of Ulmann in view of Casewell (US Pub. 2007/0277829).
Regarding claim 10, Penton discloses a valve comprising: a valve housing (see Fig. 4, main body 20, rear wall 34, and rear wall 76) comprising a valve seat (see Fig. 4 valve seat 35) and an inlet (see Fig. 4 rear opening 36), the inlet configured to receive the wearer’s exhaled breath at an inlet pressure (see Fig. 4 where inlet 36 receives the positive pressure exhaled air from the wearer); a valve flap at least partially received within the valve housing (see Fig. 4 positive pressure valve 140, which is the flap part of positive pressure valve assembly 130), wherein the valve flap is sealingly engaged with the valve seat in a closed configuration (see Fig. 4 and Col. 8 lines 40-59 where the valve 140 has a closed configuration that seals against valve seat 35) and is disengaged from the valve seat in a plurality of open configurations (see Fig. 4, Col. 8 lines 40-59 and where a first open position comes from pressure moving the peripheral skirt 146 away from the valve seat 35 so that the air can pass by the valve flap, and a second open position is shown in Fig. 4 where the valve assembly 140 is pulled away from valve seat 35 by rotation of outer cover 90, resulting in a second, more open position), the valve flap comprising a tubular projection extending away from the valve seat along a longitudinal axis (see Fig. 4 where boss 142 is a tubular projection that extends in the longitudinal axis, and away from the valve seat 35), the plurality of open configurations comprising a first open configuration and a second open configuration (see Fig. 4, Col. 8 lines 40-59 and where a first open position comes from pressure moving the peripheral skirt 146 away from the valve seat 35 so that the air can pass by the valve flap, and a second open position is shown in Fig. 4 where the valve assembly 140 is pulled away from valve seat 35 by rotation of outer cover 90, resulting in a second, more open position), wherein, in each of the plurality of open configurations, the valve is configured to allow discharge of fluid through the mask outlet (see Col. 9 line 49 to Col 10 line 20, describing operation of the valve where, when the positive pressure valve 140 is in active use, it is in an open configuration that allows fluid to pass through and be expelled from the valve device); a pin slidably received through the valve housing and coupled to the tubular projection (see Fig. 4 central shaft 132, coupled to the valve assembly 140), wherein the pin and the valve flap are together movable along the longitudinal axis relative to the valve seat (see fig. 4 and Col. 8 lines 27-59 where the central shaft 132 is axially slidable (see the motion that occurs between Figs. 9 and 10)); a valve cage coupled to the valve housing (see Fig. 4 annular body 42, peripheral wall 62); a central limiter coupled to the valve cage and extending towards the tubular projection along the longitudinal axis (see Fig. 4 central hub 44, which is centrally located, along the longitudinal axis, limiting the axial motion of the valve assembly 140, and extending in a direction towards the boss 142); a cap disposed on the valve flap opposite to the valve seat (see Fig. 4 backing plate 150, where it is understood that a cap can be defined as something that serves as a cover or protection (as per Merriam-Webster’s online dictionary, as accessed on 12/12/2025)), wherein the cap is engaged with the valve flap and movable along the longitudinal axis (see the motion of Fig. 9 to Fig. 10, and Col. 8 lines 27-59 where the backing plate 150 moves with the valve 130 and shaft 132); and a biasing member disposed between and engaged with the cap and the valve cage (see Fig. 4 biasing member 156), the biasing member configured to normally bias, via the cap, the valve flap to the closed configuration (see Col. 6 lines 42-49 where the biasing member 156 pushes the valve 140 onto away from valve seat 40 and thus towards valve seat 35, forming the closed configuration (as seen in Fig. 1)); wherein, in response to the inlet pressure at the inlet of the valve housing, the valve flap moves linearly, along the longitudinal axis (see Fig. 11 and Col. 8 lines 50-59 where, from a position where the valve 140 is against the valve seat 35, a positive inlet pressure is able to push the valve assembly 140 and shaft 132 linearly away from valve seat 35 to create an opening), from the closed configuration to the first open configuration against the biasing of the biasing member (see Figs. 10-11 and Col. 8 lines 50-59 where, from a position where the valve 140 is against the valve seat 35, the valve assembly 140 and shaft 132 move linearly against the force of the biasing member 156), wherein the linear movement of the valve flap from the closed configuration to the first open configuration causes a corresponding linear movement of the cap along the longitudinal axis (see Figs. 10-11 and Col. 8 lines 50-59 where motion of the valve 140 and shaft 132 from the closed to an open configuration includes the linear motion of the backing plate 150, which is affixed to the valve 140 and shaft 132).
Penton lacks a detailed description of wherein, in the first open configuration of the valve flap, the central limiter engages with the tubular projection to prevent further movement of the tubular projection along the longitudinal axis.
However, Bailey teaches a pressure valve for respiratory use, where in a first open configuration of the valve flap, the limiter engages with the valve assembly to prevent further movement of the valve assembly along the longitudinal axis (see Figs. 2-3 where the motion of the disk 48 from the bead portion 36 of the rim 22 is a motion along a longitudinal axis in response to a pressure, resulting in an open configuration. The displacement of the disk 48 is stopped by stops 80 (which can be a centrally located stop as seen in Col. 4 lines 58-63).
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 first open configuration of Penton to reach and stop due to the centrally located stop, as taught by Bailey, as it would allow for the valve to still open and close in response to changing pressure/ biasing forces, while limiting the movement to better prevent damage to the flexible elements and ensure that fluid can flow freely over the upper surface thereof (Bailey; see Col. 5 lines 25-32).
The modified Penton device lacks a detailed description of the valve flap transitioning, in response to the inlet pressure, from the first open configuration to the second open configuration in order to remain disengaged from the valve seat, and wherein the valve flap at least partially deforms to transition from the first open configuration to the second open configuration.
However, Ulmann teaches a valve system for a respiratory device, where a valve flap is able to transition from a first open configuration to a second open configuration in response to increased inlet pressure, resulting from a deformation of the valve flap from the first to second open configuration (see Figs. 2-3, where diaphragm 32 has a first open position (see Figs. 2-3 and 5; and Col. 3 lines 1-7 where the diaphragm sitting on the valve seat 22 is able to have slight movement/ deformation to allow for the passage of air in a low-pressure setting) and a second open position (see Fig. 3 and Col. 3 lines 62-65 where the diaphragm 32 has a second open position, where it deforms greatly under higher pressure to allow for greater flow rates)).
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 valve flap of the modified Penton device to be able to deform from its first to a second open configuration as taught by Ulmann, as it would allow for the valve to be adjustable in response to a change from a low pressure to a high pressure usage, ensuring the valve system is applicable to a wide range of respiratory applications.
The modified Penton device lacks a detailed description of a respiratory mask comprising: a seal for sealing against and around a face of a wearer; a mask inlet adapted to be placed in fluid communication with a supply of air; a mask outlet through which a wearer’s exhaled breath is emitted; and a valve fluidly disposed in the mask outlet. It is understood that Penton does disclose the valve system being used for a respiratory mask, as seen in Col. 4 line 65 to Col. 5 line 1, and thus respiratory masks have some sealing structure, inlet, and outlet.
However, Casewell teaches an exhalation valve system, that is part of a respiratory mask that further includes a seal for sealing against and around a face of a wearer (see face seal 32 in Fig. 2); a mask inlet adapted to be placed in fluid communication with a supply of air (see bosses 50/52 in Fig. 3 and [0029]); a mask outlet through which a wearer’s exhaled breath is emitted (see Figs. 2-3 where 36 is an air outlet; see also [0029]); and a valve fluidly disposed in the mask outlet (see Figs. 2-3 and [0028]-[0029] where the central aperture 68 has an exhalation 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 mask of the modified Penton device to include a sealing structure, mask inlet, and mask outlet leading to the valve as taught by Casewell, as it would provide the exhalation valve with a sealed respiratory mask system for use, that can be worn by the user, and allowing respiration through both a supply and exhaust of air.
Regarding claim 11, the modified Penton device has wherein the valve is fitted on the mask outlet (Casewell; see Fig. 3 where mask outlet at aperture 68 has the modified Penton valve).
Regarding claim 12, the modified Penton device has wherein the inlet pressure is at least 3 mbar for moving the valve flap to the plurality of open configurations against the biasing of the biasing member (Penton; see Col. 10 lines 18-20).
Regarding claim 14, the modified Penton device has wherein, in response to the inlet pressure, at least a portion of the valve flap deforms and moves non-linearly during the transition of the valve flap from the first open configuration to the second open configuration (Ulmann; see Figs. 2-3, where diaphragm 32 has a first open position (see Figs. 2-3 and 5; and Col. 3 lines 1-7 where the diaphragm sitting on the valve seat 22 is able to have slight movement/ deformation to allow for the passage of air in a low-pressure setting) and a second open position (see Fig. 3 and Col. 3 lines 62-65 where the diaphragm 32 has a second open position, where it deforms greatly under higher pressure to allow for greater flow rates), such that the deformation of the diaphragm is a non-linear motion at the outer peripheral edges have much larger displacement than the center of the diaphragm), thereby causing a further movement of the cap, along the longitudinal axis, towards the central limiter (Penton; see Fig. 4, Col. 8 lines 40-59 and where a first open position comes from pressure moving the peripheral skirt 146 away from the valve seat 35 so that the air can pass by the valve flap, thus moving the valve assembly 130 and backing plate towards the central hub 44).
Regarding claim 15, the modified Penton device has wherein the cap comprises: an inner aperture therethrough (Penton; see Fig. 4 where the backing plate 150 has a central aperture through which the shaft 132 and circumferential groove 148 of boss 142 fit), the inner aperture defining an inner diameter of the cap and configured to at least partially receive the tubular projection therethrough (Penton; see Fig. 4 where the inner space of the backing plate 150 at least partially holds and receives the boss 142), and an annular shoulder surrounding the inner aperture, wherein the annular shoulder engages with the biasing member (Penton; see Fig. 4 where an upper part of the biasing member 156 contacts a shoulder groove at the base of the central hub 44, which circumferentially surrounds the inner aperture of the backing plate 150).
The modified Penton device lacks a detailed description of wherein the inner diameter of the cap is greater than a maximum width of the central limiter.
However, Bailey further teaches where the central limiter has a smaller width than the diameter of a cap member (see Fig. 2 where hub 24 acts as a supporting cap member to disk 48, such that stop members 80 are shown to be smaller in size than the hub 24).
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 central hub stop member of the modified Penton device to be smaller in width than the aperture of the cap as taught by Bailey, as it would be a simple substitution of one size of stop member for another, to yield the predictable result of providing a stop member that extends out and stops axial movement of the valve.
Regarding claim 16, the modified Penton device has a sealing ring (Penton; see compression clamp 184 in Fig. 4), wherein the valve housing comprises a groove at least partially receiving the sealing ring therein (Penton; see Fig. 4 where a groove formed under circumferential flange 26 of the main body 20 at least partially receives the compression clamp 184), such that the sealing ring seals the valve against a body of the respiratory mask (Penton; see Col. 7 lines 25-32).
Regarding claim 17, the modified Penton device has an outlet cover at least partially enclosing the valve, the outlet cover comprising a plurality of openings therethrough (Penton; see Figs. 2 and 4, cover 90, which has apertures 100).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Penton in view of Bailey in view of Ulmann in view of Casewell as applied to claim 10 above, and further in view of Nitta.
Regarding claim 13, the modified Penton device has wherein, in the closed configuration of the valve flap, there is a minimum distance between the central limiter and the tubular projection of the valve flap.
The modified Penton device lacks a detailed description of the minimum distance between the central limiter and the tubular projection of the valve flap is between 4 mm and 6 mm.
However, Nitta teaches a respiratory device using a valve, where the displacement stroke of a valve is in the range of 2-3 mm (see [0045]).
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 distance between the central limiter and tubular projection, which is the displacement stroke of the valve, of the modified Penton device to be about 4 mm, as taught by Nitta, as it would provide a small displacement stroke distance that is consistent with the size of an exhalation valve for a respiratory mask. The specific distance of 4 to 6 mm lacks criticality, and as such as person of ordinary skill in the art, upon seeing a distance of 3 mm, would be able to make an obvious design choice to alter to the distance to other close measurements, such as 4 mm. Furthermore, the specification appears to note that the distance can be within this range (see page 15 lines 1-4, where an example distance is 2.5 mm).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kohnke (US Pat. 4,071,025) and Capon et al. (US Pat. 6,860,267) are cited to show biased valve members with movable valves and/or valve stop members.
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-Thurs 9:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785