DETAILED ACTION
Claims 1 and 71-92 were filed with the amendment dated 01/16/2026. Claims 2-70 were cancelled.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/16/2026 has been entered.
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
Applicant argues that WO2016/117830 (“Kim”) fails to teach or suggest “a biasing member operatively coupled to the actuator, wherein the biasing member applies a variable resistance force onto the actuator during movement thereof” (see Remarks at page 2 and repeated on page 4 and page 6). The examiner respectfully disagrees. Kim clearly discloses a biasing member (spring 96) that is operatively coupled to the actuator (95 – Figs 12 and 13 clearly show spring 96 contacting actuator 95). The biasing member (spring 96) applies a variable resistance to the actuator (95) during movement of the actuator because as the biasing member (spring 96) is pressed upwards, the force applied by the spring is adjusted.
Applicant further argues that Kim fails to teach or suggest “wherein the variable resistance force applied by the biasing member counters a force exerted onto the actuator caused by the gas pressure at the inlet” (see Remarks at page 2 and repeated on page 4 and page 6). The examiner respectfully disagrees. The variable resistance force applied by the spring (biasing member 96) (i.e., force pushing downwards in Fig 12) is counter to a force exerted on the actuator (95) by gas pressure at the inlet (pressure of gas pushing upwards on bottom of 95). Figure 12 shows the condition of the force of the inlet pressure pushing up on the actuator (95) counter to downward force of biasing member (spring 96).
Applicant further argues that Kim fails to teach or suggest “wherein the actuator moves until it reaches an equilibrium position where the force exerted on the actuator equals the variable resistance force, to substantially maintain the gas pressure at the selected pressure level” (see Remarks at page 2 and repeated at page 4 and page 6). The examiner respectfully disagrees. The actuator (95) of Kim and that of the Applicant operate the same. A spring member/biasing member pushes down on the actuator while a pressure from a fluid pushes up on the actuator. An equilibrium position can be reached if the pressure of the fluid pushing up is the same as that of the spring/biasing member pushing down. In Kim, as pressure pushes up on the variable resistance of the biasing member, an equilibrium position is reached if that pressure matches that of the force of the biasing member. Such as position is shown in Fig 12 with the actuator 95 open. There is not a requirement for permanent or long term equilibrium position being held. Furthermore, the claims do not require that the equilibrium position is reached in an open position.
Applicant argues that because Kim discloses a relief valve, it cannot regulate the gas pressure with a PEEP range. However, Kim does disclose a valve for controlling (i.e., broadly regulating) the oxygen pressure for a respirator (see Abstract). Furthermore, Kim discloses adjusting the valve to a desired oxygen pressure (see Translation at first five paragraphs on page 14).
Applicant argues that because Kim discloses that the actuator (95) can vibrate and buzz (see Remarks at page 3), then Kim cannot disclose an equilibrium position. The examiner respectfully disagree. The actuator (95) may vibrate at certain pressures, but that does not mean that at certain pressures at the inlet, the actuator would not be at equilibrium. The claims do not require that the equilibrium position is reached in an open position, or that equilibrium must be held for a certain amount of time. Furthermore, the claims require “to substantially maintain the gas pressure,” which would still be met by any vibrations. The valves of the applicant and Kim have the same general structure and would operate the same under same pressures.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 71, 72, 75-78, 81-82, 85-92 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2016117830 (“Kim”) (as evidenced by Translation).
With regard to claim 1, Kim discloses a valve (90) for use with a respiratory system (Figs 1, 2, 11-14) arranged to convey a breathable gas to a patient (respirator, page 1, lines 5-9), wherein the valve (90) allows gas from within the respiratory system to exit, comprising: a valve body (91a) including an inlet (inlet from 91 towards seat 93, see annotated Figs) and an outlet (gas exits out “H”), said inlet (inlet from 91 towards seat 93, see annotated figs) configured to be in fluid communication with the respiratory system (see Fig 2); an actuator (95) disposed within the valve body (91a), in a flow path between the inlet (inlet from 91 towards seat 93, see annotated Figs) and the outlet (“H”); a biasing member (spring 96), wherein the biasing member (96) is operatively coupled to the actuator (5) (shown in Figs 11-12; 96 contacts 95 and is, therefore, operatively coupled) and the biasing member (96) applies a variable resistance force (variable force based on spring force/constant and based on adjustment of 94 setting pressure of spring) onto the actuator (95) during movement thereof; and an outlet member (94) comprising an orifice (orifice is opening for “H”) for the gas to exit (see Fig 12), the outlet member (94) comprising a supporting member (97a; page 13, lines 39-44) (supporting member 97a is the non-cross-hatched portion shown in Figs 11 and 12; comparing Figs 11 and 12, can see that 95 and hatched portion moves relative to non-hatched 97a portion), wherein the actuator (95) is biased (biased via spring 96) towards the inlet (inlet from 91 towards seat 93) (see Fig 11 position), the actuator (95) configured for movement away from the inlet when aa gas pressure at the inlet exceeds a selected pressure level (position in Fig 12; page 14, lines 5-8), said movement adjusting the flow path between the inlet (inlet from 91 towards seat 93, see annotated Figs) and the outlet (outlet through “H”), to regulate the gas pressure in the respiratory system within a predetermined positive end expiratory pressure (PEEP) range (“set pressure” is considered to be a predetermined positive end expiratory pressure as it is also in a respiratory device; see also page 14, line 14: “set pressure”) wherein the selected pressure level is within the predetermined PEEP range (selected pressure to be set is within a predetermined range), the actuator (95) having an actuator orifice (orifice in middle of 95 through which portion of 97a extends; see annotated Figs) formed therein which accommodates the supporting member (97a) so that the actuator (95) moves along the supporting member (97a) when moving away from the inlet (compare Figs 11 and 12; 95 and connected cross-hatched portion around 97a moves along the non-hatched part that is 97a; Fig 12 shows the difference in location between the closed position and open position; thus the actuator and related components move along 97a); wherein the variable resistance force applied by the biasing member (96) counters a force exerted onto the actuator (95) caused by gas pressure at the inlet (pressure from 91 pushing up on 95 is counter to spring force pushing down, see Fig 11), wherein the actuator (95) moves until it reaches an equilibrium position where the force exerted on the actuator (95) equals the variable resistance force, to substantially maintain gas pressure at the selected pressure level (an equilibrium position can be reached if the pressure of the fluid pushing up is the same as that of the spring/biasing member pushing down. In Kim, as pressure pushes up on the variable resistance of the biasing member, an equilibrium position is reached if that pressure matches that of the force of the biasing member. Such as position is shown in Fig 12 with the actuator 95 open. There is not a requirement for permanent or long term equilibrium position being held. Furthermore, the claims do not require that the equilibrium position is reached in an open position).
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With regard to claim 71, Kim discloses that the supporting member (97a) for the actuator (95) is configured to guide and stabilize the movement of the actuator (95) (97a guides sliding movement of 95 up and down, compare Figs 11-12; and stabilizes by preventing misalignment of 95).
With regard to claim 72, Kim discloses that the actuator (95) comprises a substantially planar lower surface (bottom is planar, see annotated Figs); or the actuator (95) comprises a circular disk (diaphragm would be circular because threaded connections and openings of 94, 91a requires circular shape), wherein the circular disk comprises a substantially planar lower surface (bottom surface is planar, see annotated Figs).
With regard to claim 75, Kim discloses that the biasing member is a spring (spring 96).
With regard to claim 76, Kim discloses that the variable resistance force applied onto the actuator (95) by the biasing member (spring 96) is at least partially dependent on: a spring constant (spring 96 inherently has a spring constant that determines a force applied), compression of a spring, and/or displacement of the actuator from a valve seat, wherein the valve seat (93) is formed by a portion of the valve body (91a, shown in Figs 11-12).
With regard to claim 77¸Kim discloses that gas pressure at the inlet (inlet from 91 into seat 93) applies a lifting force (Flift) onto the actuator (95) (pressure from 91 pushes up on actuator 95), in a direction which is opposite to the variable resistance force (force from spring 96) applied onto the actuator (95) by the biasing member (spring 96 pushes down onto actuator, see Figs 11-12), wherein the lifting force may be calculated from Flift=P * A actuator, where P = gas pressure at the inlet of the valve body; A actuator = area of the actuator exposed to the gas pressure at the inlet of the valve body (it is inherent that the lifting force is calculated by the gas pressure and area of the actuator 95 exposed through the inlet; inlet is opening at 91 at seat 93).
With regard to claim 78, Kim discloses that a position of the actuator (95) is determined by a relative relationship of F bias and Flift, wherein F bias is the variable resistance (spring force) applied onto the actuator (95) by the biasing member (spring 96), and wherein the actuator (95) is displaced from a valve seat (93), wherein the valve seat (93) is formed by a portion of the valve body (91, see Figs 11-12), when Fiift is greater than F bias (inherently in order to push actuator 95 up off seat 93, the lift force (at A) must be greater than spring force pushing down).
With regard to claim 81, Kim discloses that the valve (90) is arranged to compensate for pressure variation (opens upon pressure surpassing a pressure threshold). The phrase “for pressure variation caused by unintentional leaks by reducing a gas flow path size through the valve” is a statement of intended use (intended use of an apparatus does not differentiate the apparatus claim from the prior art. See MPEP 2114).
With regard to claim 82¸Kim discloses the valve (90) is arranged to compensate for pressure variation (opens upon pressure surpassing a pressure threshold). The phrase “for pressure variation caused by patient's breathing by allowing a variable portion of the gas within the respiratory system to flow through the valve and exit the respiratory system” is a statement of intended use (intended use of an apparatus does not differentiate the apparatus claim from the prior art. See MPEP 2114). Kim does disclose that the valve allows a portion of gas within a respiratory system (page 1, lines 5-10) and allow for flow through the valve (90) and exit the system (through H).
With regard to claim 85, Kim discloses that the valve (90) is configured to be removably attached (removable via threads between 94 and 91a) to a venting orifice (opening in 91a in which 94/95 is connected) of the respiratory system, wherein the venting orifice is provided in a T-piece device (shown in Fig. 2, T-piece generally between inlet 11 and right and left portions of T at 90 and 12.
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With regard to claim 86, Kim discloses a device (generally shown in Figs 1-2) for facilitating regulating pressure of gases supplied to a patient (page 1, lines 5-10; page 7, lines 30-35), the device comprising: a housing (10) defining a chamber (91), the housing (10) having an inlet (11; page 7, lines 34-35) configured for connection with a gas flow source (oxygen tank, page 12, line 1) providing a flow of gases to the chamber (91), an outlet (12) configured to direct gases out from the chamber, and a vent (90) comprising an actuator (95) for controlling venting of gases from the chamber (91) through the vent (90); a biasing member (spring 96) which biases the actuator (95) towards a seated position (position in Fig. 11; page 13, lines 42-44) and applies a variable resistance force (variable force based on spring force/constant and based on adjustment of 94 setting pressure of spring) onto the actuator (95) during movement thereof; and an outlet member (94) comprising an orifice (H) for the vented gases to exit (see Fig 12), the outlet member (94) comprising a supporting member (97a) ,wherein the vent (90) and the actuator (95) are mutually adapted so that the actuator (95) has an exposed area which is exposed to the gases in the chamber (bottom side of 95 exposed from seat 93), wherein the biasing member (spring 96) has a spring constant (inherently has spring constant) selected relative to the exposed area of the actuator whereby the actuator (95) remains in the seated position (Fig 11 position) until a pressure of the gases in the chamber (91) exceeds a selected pressure level (page 14, lines 1-14), the actuator (95) having an actuator orifice (opening in 95 through which portion of 97a extends) formed therein which accommodates the supporting member (97a) so that the actuator (95) moves along the supporting member (97a) when moving relative to the seated position (when move towards Fig. 12 position) (compare Figs 11 and 12; 95 and connected cross-hatched portion around 97a moves along the non-hatched part that is 97a; Fig 12 shows the difference in location between the closed position and open position; thus the actuator and related components move along 97a); wherein the variable resistance force applied by the biasing member (96) counters a force exerted onto the actuator (95) caused by gas pressure at the inlet (pressure from 91 pushing up on 95 is counter to spring force pushing down, see Fig 11), wherein the actuator (95) moves until it reaches an equilibrium position where the force exerted on the actuator (95) equals the variable resistance force, to substantially maintain gas pressure at the selected pressure level (an equilibrium position can be reached if the pressure of the fluid pushing up is the same as that of the spring/biasing member pushing down. In Kim, as pressure pushes up on the variable resistance of the biasing member, an equilibrium position is reached if that pressure matches that of the force of the biasing member. Such as position is shown in Fig 12 with the actuator 95 open. There is not a requirement for permanent or long term equilibrium position being held. Furthermore, the claims do not require that the equilibrium position is reached in an open position).
With regard to claim 87, Kim discloses a pressure regulating device for facilitating regulating pressure of gases supplied to a patient (see Figs 1-2, 11-12) (page 1, lines 5-10; page 7, lines 30-35), the device comprising: a housing (10) defining a chamber (91), the housing (10) comprising an inlet (11) (11; page 7, lines 34-35) couplable with a flow source providing a flow of gases to the chamber (oxygen tank, page 12, line 1), an outlet (12) couplable with a patient interface for supplying gases to the patient from the chamber (page 9, line 35 to page 10, line 3), and a vent (90) comprising an actuator (95) for controlling venting of gases from the chamber (91) through the vent (90) (page 13, lines 30-38); a biasing member (spring 96) which biases the actuator (95) towards a seated position (position in Fig. 11) (page 13, lines 42-44) and applies a variable resistance force (variable force based on spring force/constant and based on adjustment of 94 setting pressure of spring) onto the actuator (95) during movement thereof; whereby the actuator (95) remains in the seated position (on seat 93, Fig. 11) until pressure of the gases in the chamber (91) exceeds a selected pressure level (page 13, lines 5-8, 14, “set pressure”); and an outlet member (94) comprising an orifice (H) for the vented gases to exit (see Fig. 12), the outlet member (94) comprising a supporting member (97a) aligned with a venting axis (“aligned with” because longitudinal axis of 97a is parallel to longitudinal axis of gas flow out of H; see also Fig. 12), the actuator (95) having an actuator orifice (opening within 95 that part of 97a extends through, see Figs 11-12) formed therein which accommodates the supporting member (97a) so that the actuator (95) moves along the supporting member (97a) when moving relative to the seated position (from Fig 11 to Fig 12) (compare Figs 11 and 12; 95 and connected cross-hatched portion around 97a moves along the non-hatched part that is 97a; Fig 12 shows the difference in location between the closed position and open position; thus the actuator and related components move along 97a); wherein the variable resistance force applied by the biasing member (96) counters a force exerted onto the actuator (95) caused by gas pressure at the inlet (pressure from 91 pushing up on 95 is counter to spring force pushing down, see Fig 11), wherein the actuator (95) moves until it reaches an equilibrium position where the force exerted on the actuator (95) equals the variable resistance force, to substantially maintain gas pressure at the selected pressure level (an equilibrium position can be reached if the pressure of the fluid pushing up is the same as that of the spring/biasing member pushing down. In Kim, as pressure pushes up on the variable resistance of the biasing member, an equilibrium position is reached if that pressure matches that of the force of the biasing member. Such as position is shown in Fig 12 with the actuator 95 open. There is not a requirement for permanent or long term equilibrium position being held. Furthermore, the claims do not require that the equilibrium position is reached in an open position).
With regard to claim 88, Kim discloses that the biasing member (spring 96) and the actuator (95) are mutually adapted to maintain the pressure of the gases within a predetermined positive end expiratory pressure (PEEP) range regardless of a flow rate of the gases within a predetermined flow rate range (page 14, lines 12-14: “therefore, the valve disk 95 is operated only at the set pressure”).
With regard to claim 89, Kim discloses that the biasing member (spring 96) is disposed in a flow path of the vented gases (shown in Fig 12, vented gases pass from 91 to H by passing the spring 96).
With regard to claim 90, Kim discloses that the biasing member (spring 96) engages the outlet member (94) and the actuator (95) (shown best in Fig 12).
With regard to claim 91, Kim discloses that when the gas pressure is at or higher than the selected pressure level (level set for spring by adjusting 97) and there is a further increase in gas pressure, the actuator (95) is configured to move away from the inlet (as pressure rises above minimum pressure required to lift spring 96, actuator 95 will continue to raise upwards due to increased force from gas pressure pushing up on spring and actuator).
With regard to claim 92, Kim discloses that when the gas pressure is at or higher than a selected pressure level (level set by spring by adjusting 97) and there is a decrease in the gas pressure, the actuator (95) is configured to move toward the inlet (as pressure drops below force of spring, then the actuator 95 moves downward).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 73, 74, 79, 80, 83, and 84 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016117830 (“Kim”) (as evidenced by Translation).
With regard to claim 73, Kim discloses all the claimed features with the exception of disclosing a radius of the circular disk (membrane 95) is within a range of 0.2 mm to 3 mm of a radius of the inlet .
Kim does disclose that the circular disk (95) would inherently have a radius and that it is a range of the radius of the inlet (inlet from 91 at seat 93) of the valve body (91a).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the radius of the circular disk within any suitable range of the inlet, such as a range of 0.2 mm to 0.3 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
With regard to claim 74, Kim discloses the actuator (95) has an area greater than a cross sectional area of the inlet (inlet where 91 meets 93) (95 is shown having a greater cross-sectional area of the inlet at the seat 93, see Fig 11).
Kim discloses all the claimed features with the exception of disclosing a difference between the area of the actuator and the inlet of the valve body is within a range of 0 to 80mm2, or 1 to 20mm2.
Applicant has not disclosed that having a difference between the area of the actuator and the inlet of the valve body is within a range of 0 to 80mm2, or 1 to 20mm2 solves any stated problem or is for any particular purpose. Moreover, it appears that the actuator/valve would perform equally well with having any suitable difference in area between the actuator and inlet.
Accordingly, it would have been a matter of obvious design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to make the difference of area between the actuator and inlet be any suitable size, such as within a range of 0 to 80mm2, or 1 to 20mm2 because the difference in area does not appear to provide any unexpected results.
With regard to claim 79, Kim discloses all the claimed features with the exception of disclosing that the spring constant is smaller than 0.05N/mm.
Applicant has not disclosed that having the spring constant smaller than 0.05N/mm solves any stated problem or is for any particular purpose. Rather, the specification provides a variety of ranges for the spring constant (para [0250]). Moreover, it appears that the actuator/valve would perform equally well with having any suitable spring constant for the biasing member.
Accordingly, it would have been a matter of obvious design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to make the spring constant of Kim be any suitable size, such as smaller than 0.05N/mm because the spring constant does not appear to provide any unexpected results.
With regard to claim 80, Kim discloses all the claimed features with the exception of disclosing that the spring constant is between 0.005 to 0.02 N/mm.
Applicant has not disclosed that having the spring constant between 0.005 to 0.02 N/mm solves any stated problem or is for any particular purpose. Rather, the specification provides a variety of ranges for the spring constant (para [0250]). Moreover, it appears that the actuator/valve would perform equally well with having any suitable spring constant for the biasing member.
Accordingly, it would have been a matter of obvious design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to make the spring constant of Kim be any suitable size, such as between 0.005 to 0.02 N/mm because the spring constant does not appear to provide any unexpected results.
With regard to claim 83, Kim discloses that the respiratory system (page 1, lines 6-10) is configured to deliver a flow rate of breathable gas to a patient when delivering respiratory therapy (“patient” page 1, line 7).
Kim discloses all the claimed features with the exception of disclosing that the respiratory system is configured to deliver a flow rate of 5 - 15 L/min of the breathable gas.
Applicant has not disclosed that having the flow rate of 5 - 15 L/min solves any stated problem or is for any particular purpose. Furthermore, the specification discloses a variety of ranges for the flow rate (see para [0080]). Moreover, it appears that the valve would perform equally well with any flow rate, such as flow rate of 5 - 15 L/min.
Accordingly, it would have been a matter of obvious design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to make the flow rate delivered by Kim be 5-15 L/min because the flow rate does not appear to provide any unexpected results.
With regard to claim 84, Kim discloses a predetermined PEEP range (see page 14, line 14: “set pressure”).
Kim discloses all the claimed features with the exception of disclosing that the predetermined PEEP range is between 5 and 15cm H20 when delivering PEEP.
Applicant has not disclosed that having the predetermined PEEP range be between 5 and 15cm H20 solves any stated problem or is for any particular purpose. Furthermore, the specification discloses a variety of ranges (see para [0119]).
Accordingly, it would have been a matter of obvious design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to make the predetermined PEEP range of Kim be between 5 and 15cm H20 when delivering PEEP, because the flow rate does not appear to provide any unexpected results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Pat. No. 11,590,305 with a valve for use with a respiratory device.
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/JESSICA CAHILL/Primary Examiner, Art Unit 3753