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 .
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Aelen et al. (US 2021/0244863A1; hereinafter “Aelen”) in view of Pan (US 10,857,270B2).
In relation to independent claim 1, this claim recites:
a breast pump system comprising: a first kit (30); and a second kit (32) or a buffer (130), a pump (16) for delivering a negative pressure;
a valve arrangement (40,42) which selectively provides an interconnection between the pump, the ambient pressure, the first kit and the second kit or buffer; and
a controller for controlling the valve arrangement,
wherein the valve arrangement comprises: a first valve unit (40) connected between the first kit (30) and the pump (16) and a second valve unit (42) connected between the second kit (32) or buffer and the pump (16) or the first valve unit (40),
wherein the first and second valve units (40,42) are controllable to connect the first kit to a selected one of the pump, the ambient pressure and the second kit or buffer,
wherein the first and second valve units (40, 42) each comprise a single valve actuator,
characterized in that the second kit (32) or buffer comprises a buffer (130),
the first valve unit (40) comprises a threeport valve (140) which couples the first kit, the ambient pressure and the pump, and the second valve unit (42) couples the buffer to the first valve unit or to a pressure stop.
A breast pump system comprising: a first kit (30); and a second kit (32) or a buffer (130), a pump (16) for delivering a negative pressure;
Aelen discloses a breast pump system comprising a first kit, a buffer, and a pump. Specifically, Aelen discloses: "a breast pump device comprising an expression kit designed to subject a breast of a user of the device to a pressure profile... a pump element configured to create the pressure profile in the expression kit... and a volume element configured to store vacuum in the pump arrangement." (Aelen ¶ [0001]).
a valve arrangement (40,42) which selectively provides an interconnection between the pump, the ambient pressure, the first kit and the second kit or buffer;
Aelen discloses a valve arrangement. Specifically, Aelen discloses: “a storage switching mechanism arranged between the expression kit air conduit and the volume element, configured to switch between a position of direct connection of the expression kit air conduit to the volume element… and a position of disconnection” (Aelen ¶ [0010]), and “an environment switching mechanism arranged between the expression kit air conduit and the environment of the pump arrangement, configured to switch between a position of opening the expression kit air conduit to the environment… and a position of closing” (Aelen ¶ [0019]).
and a controller for controlling the valve arrangement,
Aelen discloses a controller. Specifically, Aelen discloses: "a controller 53 that is configured to control operation of the pump arrangement 5". (Aelen ¶ [0050]).
wherein the valve arrangement comprises: a first valve unit (40) connected between
the first kit (30) and the pump (16) and a second valve unit (42) connected between the
second kit (32) or buffer and the pump (16) or the first valve unit (40),
Aelen discloses a first and second valve unit. Specifically, Aelen discloses: "an environment switching mechanism 57" and "a storage switching mechanism 58". (Aelen ¶ [0051], [0052]).
wherein the first and second valve units (40,42) are controllable to connect the first
kit to a selected one of the pump, the ambient pressure and the second kit or buffer,
Aelen discloses controlling the valves to connect the kit to the pump, ambient pressure, or
buffer. Specifically, Aelen discloses: "setting a condition of the pump arrangement in which
the storage switching mechanism is in a position for connecting the expression kit air
conduit to the volume element, and the environment switching mechanism is in a position
for disconnecting the expression kit air conduit from the environment". (Aelen ¶ [0023]).
wherein the first and second valve units (40, 42) each comprise a single valve actuator,
Aelen discloses single valve actuators. Specifically, Aelen discloses: "the storage
switching mechanism comprises a solenoid valve... the environment switching mechanism
may comprise a solenoid valve." (Aelen ¶ [0018], [0019]).
characterized in that the second kit (32) or buffer comprises a buffer (130),
Aelen discloses a buffer. Specifically, Aelen discloses: “the volume element comprises an air container having a significantly larger diameter than the air conduits.” (Aelen ¶ [0018]). Aelen further states: “the air container 54 is a volume element serving as a space, particularly a vacuum buffer”. (Aelen ¶ [0055]).
the first valve unit (40) comprises a three-port valve (140) which couples the first kit,
the ambient pressure and the pump, and the second valve unit (42) couples the buffer
to the first valve unit or to a pressure stop.
Aelen discloses valve units but does not expressly disclose that the first valve unit comprises a three-port valve which couples the first kit, the ambient pressure and the pump. To the extent Aelen does not expressly disclose a three-port valve, Pan fills this gap by disclosing a three-way valve for coupling components in a breast pump arrangement. Specifically, Pan discloses: “The suction valve 12 and the venting valve 13 are both designed as three-way-valves.” (Pan col. 5, ll. 17-18).
Motivation to combine.
It would have been obvious to combine Aelen with Pan because both references are directed to pump arrangements for breast pumps and deal with similar pneumatic switching mechanisms. A person of ordinary skill in the art would have been motivated to incorporate the three-way valves of Pan into the pump arrangement of Aelen to simplify the pneumatic circuit and reduce the overall number of components and connections, thereby increasing reliability and reducing manufacturing costs.
In relation to independent claim 2, this claim recites:
A breast pump system comprising: a first kit (30); and a second kit (32) or a buffer (130), a pump (16) for delivering a negative pressure; a valve arrangement (40,42) which selectively provides an interconnection between the pump, the ambient pressure, the first kit and the second kit or buffer; and a controller for controlling the valve arrangement, wherein the valve arrangement comprises: a first valve unit (40) connected between the first kit (30) and the pump (16) and a second valve unit (42) connected between the second kit (32) or buffer and the pump (16) or the first valve unit (40), wherein the first and second valve units (40,42) are controllable to connect the first kit to a selected one of the pump, the ambient pressure and the second kit or buffer, wherein the first and second valve units (40, 42) each comprise a single valve actuator, characterized in that the second kit (32) or buffer comprises a buffer,
the first valve unit (40) comprises a pair of threeport valves which couple the first kit, the ambient pressure, the buffer and the pump, and the second valve unit comprises a pair of three port valves which couple the buffer, the first kit, the pump and a pressure stop.
A breast pump system comprising: a first kit (30); and a second kit (32) or a buffer
(130), a pump (16) for delivering a negative pressure; a valve arrangement (40,42)
which selectively provides an interconnection between the pump, the ambient
pressure, the first kit and the second kit or buffer; and a controller for controlling the
valve arrangement, wherein the valve arrangement comprises: a first valve unit (40)
connected between the first kit (30) and the pump (16) and a second valve unit (42)
connected between the second kit (32) or buffer and the pump (16) or the first valve
unit (40), wherein the first and second valve units (40,42) are controllable to connect
the first kit to a selected one of the pump, the ambient pressure and the second kit or
buffer, wherein the first and second valve units (40, 42) each comprise a single valve
actuator, characterized in that the second kit (32) or buffer comprises a buffer,
Aelen discloses these limitations as discussed above with respect to claim 1.
the first valve unit (40) comprises a pair of three-port valves which couple the first kit,
the ambient pressure, the buffer and the pump, and the second valve unit comprises a
pair of three port valves which couple the buffer, the first kit, the pump and a pressure stop.
Aelen discloses valve units but does not expressly disclose a pair of three-port valves. To the extent Aelen does not expressly disclose a pair of three-port valves, Pan fills this gap by disclosing a pump arrangement using multiple three-way valves to selectively couple the components. Specifically, Pan discloses: “The suction valve 12 and the venting valve 13 are both designed as three-way-valves.” (Pan col. 5, ll. 17-18).
Motivation to combine.
Based on the above teachings, it would have been obvious to combine Aelen with Pan because both references are directed to pump arrangements for breast pumps. A person of ordinary skill in the art would have been motivated to incorporate pairs of three-way valves of Pan into the pump arrangement of Aelen to provide a more flexible and redundant pneumatic routing system capable of handling complex pressure equalization cycles.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Aelen et al. (US 2021/0244863A1; hereinafter “Aelen”) in view of Pan (US 10,857,270B2), as discussed above, and in further view of O’Toole et al. (US 2018/0361040A1; hereinafter “O’Toole”).
In relation to claim 10, this claim depends from claim 1 and further recites: the breast pump system of claim 1, wherein each kit comprises a suction cup, comprising two air chambers separated by a flexible movable membrane.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein each kit comprises a suction cup, comprising two air chambers separated by a flexible movable membrane.
Aelen and Pan disclose breast shields but do not expressly disclose two air chambers separated by a flexible movable membrane. To the extent the base combination does not expressly disclose this, O’Toole fills this gap by disclosing a flexible diaphragm separating the air side from the milk-flow side. Specifically, O’Toole discloses: “The rest of the pneumatic system 200 forms the air side 202 and is separated from contact with milk. This is achieved by way of a flexible diaphragm 13 which forms a seal between the two sides of the system. The diaphragm 13 has a milk-flow side 13A and an air side or pumping side 13B.” (O’Toole ¶ [0143]).
Motivation to combine.
It would have been obvious to combine the base combination of Aelen and Pan with O’Toole because all references relate to breast pump systems. A person of ordinary skill in the art would have been motivated to incorporate the flexible diaphragm separating the two sides of the system taught by O’Toole into the expression kit of the base combination to prevent milk from entering and contaminating the pneumatic lines and pump components.
Claims 3, 4, 5, 6, 7, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Pan (US 10,857,270B2) in view of Aelen et al. (WO 20200007671A1; hereinafter “Aelen '671”).
In relation to independent claim 3, Claim 3 recites:
A breast pump system comprising: a first kit (30); and a second kit (32) or a buffer (130), a pump (16) for delivering a negative pressure;
a valve arrangement (40,42) which selectively provides an interconnection between the pump, the ambient pressure, the first kit and the second kit or buffer; and
a controller for controlling the valve arrangement,
wherein the valve arrangement comprises: a first valve unit (40) connected between the first kit (30) and the pump (16) and a second valve unit (42) connected between the second kit (32) or buffer and the pump (16) or the first valve unit (40),
wherein the first and second valve units (40,42) are controllable to connect the first kit to a selected one of the pump, the ambient pressure and the second kit or buffer,
wherein the first and second valve units (40, 42) each comprise a single valve actuator,
characterized in that the second kit or buffer comprises a second kit, and
wherein the first and second valve units (40, 42) each comprise a pair of three-port valves coupled together, thereby having four external ports.
A breast pump system comprising: a first kit (30); and a second kit (32) or a buffer
(130), a pump (16) for delivering a negative pressure;
Pan discloses a double breast pump system. Specifically, Pan discloses: “a pump arrangement 1 for a double breast pump 2… first and second expression kits 3, 4… a pump 9 which for example can be an electrically driven pump 9… generating a negative pressure (suction).” (Pan col. 4, ll. 18-41).
a valve arrangement (40,42) which selectively provides an interconnection between
the pump, the ambient pressure, the first kit and the second kit or buffer;
Pan discloses a valve arrangement. Specifically, Pan discloses: “a suction valve 12 and a venting valve 13… The suction valve 12 is on the one hand connected to the pump 9… and on the other hand suction valve 12 connects to the expression kits 3, 4… Venting valve 13… opens via an opening 17 to the environment”. (Pan col. 5, ll. 1-34).
and a controller for controlling the valve arrangement,
Pan discloses a controller. Specifically, Pan discloses: “The pump arrangement 1 can further comprise a control unit 20… The control unit 20 allows the user of the double breast pump 2 to control several operating parameters of the pump arrangement 1.” (Pan col. 5, ll. 35-42).
wherein the valve arrangement comprises: a first valve unit (40) connected between the first kit (30) and the pump (16) and a second valve unit (42) connected between the second kit (32) or buffer and the pump (16) or the first valve unit (40),
Pan discloses first and second valve units. Specifically, Pan discloses: “The suction valve 12 is on the one hand connected to the pump 9… and to the expression kits 3, 4… The venting valve 13 is connected to the expression kits 3, 4”. (Pan col. 5, ll. 3-7).
wherein the first and second valve units (40,42) are controllable to connect the first kit to a selected one of the pump, the ambient pressure and the second kit or buffer,
Pan discloses connecting the first kit to the pump or ambient pressure. Specifically, Pan discloses: “each of the expression kits 3, 4 can be alternatingly pressurized and vented by way of opening and closing the air conduits 10, 11 and the venting conduits 15, 16 by opening and closing the respective outlets or inlets of the suction valve 12 and the venting valve 13.” (Pan col. 6, ll. 23-28). However, Pan does not expressly disclose connecting the first kit directly to the second kit for pressure equalization. To the extent Pan does not expressly disclose this, Aelen ’671 fills this gap by disclosing a direct connection between the kits. Specifically, Aelen ’671 discloses: “the first air conduit and the second air conduit are connectable to and disconnectable from each other directly through an intermediate switching mechanism”. (Aelen ’671, page 4, lines 1 and 2).
wherein the first and second valve units (40, 42) each comprise a single valve actuator,
Pan discloses single valve actuators. Specifically, Pan discloses: “the pump is an electrically driven pump and the suction and venting valves are solenoid valves.” (Pan col. 3, ll. 27-28).
characterized in that the second kit or buffer comprises a second kit,
Pan discloses a second kit. Specifically, Pan discloses: “first and second expression kits 3, 4”. (Pan col. 4, ll. 20-21).
and wherein the first and second valve units (40, 42) each comprise a pair of threeport valves coupled together, thereby having four external ports.
Pan discloses three-port valves but does not expressly disclose them coupled together as a pair having four external ports. Specifically, Pan discloses: “The suction valve 12 and the venting valve 13 are both designed as three-way-valves.” (Pan col. 5, ll. 18-19). To the extent Pan does not expressly disclose pairing them with four external ports, Aelen ’671 fills this gap by disclosing combining switching mechanisms into single units. Specifically, Aelen ’671 discloses: “the first suction switching mechanism and the second suction switching mechanism are combined in a single unit such as a single solenoid with two connections.” (Aelen ’671, page 6, lines 5-7). It would have been obvious to arrange the three-way valves as a pair coupled together to achieve the required routing logic.
Motivation to combine.
It would have been obvious to combine Pan with Aelen ’671 because both references are directed to pump arrangements for double breast pumps assigned to the same entity. A person of ordinary skill in the art would have been motivated to incorporate the direct kit-to-kit connection and combined valve actuators of Aelen ’671 into the pump arrangement of Pan to “directly transfer vacuum between the air conduits… and to thereby support the functioning of the pump” (Aelen ’671 ¶ [0118]) and achieve “compactness of design” (Aelen ’671, Abstract and page 3, line 8).
In relation to claim 4, this depends from claim 3 and further recites: the breast pump system of claim 3, wherein the controller is adapted to control the valve arrangement to couple: the first kit to the pump and the second kit or buffer to the ambient pressure in a first configuration; the first kit and the second kit together in a second configuration to equalize a pressure level between the first kit and second kit; and the second kit to the pump and the first kit to the ambient pressure in a third configuration.
Base rejection incorporated.
The rejection of claim 3 is incorporated herein.
wherein the controller is adapted to control the valve arrangement to couple: the first kit to the pump and the second kit or buffer to the ambient pressure in a first configuration; the first kit and the second kit together in a second configuration to equalize a pressure level between the first kit and second kit; and the second kit to the pump and the first kit to the ambient pressure in a third configuration.
Pan discloses the first and third configurations (alternating suction) but does not expressly disclose the second configuration coupling the kits together. To the extent Pan does not expressly disclose this, Aelen ’671 fills this gap by disclosing this exact control sequence. Specifically, Aelen ’671 discloses: “a first step of creating a vacuum in a first expression kit and releasing a vacuum in a second expression kit under the influence of the pump, a second step of turning the situation around by first establishing a short circuit between the first expression kit and the second expression kit, as a result of which the vacuum in the first expression kit is released to some extent and a vacuum is created in the second expression kit to some extent, a third step of further releasing the vacuum in the first expression kit and further creating a vacuum in the second expression kit under the influence of the pump”. (Aelen ’671, page 9, starting in line 30).
Motivation to combine.
Aelen ’671 provides the motivation for this control sequence to “support the functioning of the pump” and allow it to be “relatively small”. (Aelen ’671, Abstract).
In relation to claim 5, this claim depends from claim 4 and further recites: the breast pump system of claim 4, wherein the controller comprises a cyclic pump waveform generator for controlling the pump and for controlling the valve arrangement.
Base rejection incorporated.
The rejection of claim 4 is incorporated herein.
wherein the controller comprises a cyclic pump waveform generator for controlling
the pump and for controlling the valve arrangement.
Pan discloses controlling the pump and valve arrangement. Aelen ’671 further discloses doing so in a cyclic repetitive algorithm. Specifically, Aelen ’671 discloses: “a controller that is configured to control operation of the pump arrangement according to the following repetitive algorithm of successive steps”. (Aelen, page 6, lines 11-14). It would have been obvious to a person of ordinary skill in the art to implement this repetitive algorithm using a cyclic waveform generator as a standard electronic control mechanism for repetitive cyclic operations.
Motivation to combine.
It would have been obvious to use a cyclic waveform generator to implement the repetitive algorithm disclosed in Aelen ’671 because such generators are standard components in electronic controllers for generating repeating control signals.
In relation to claim 6, this claim depends from claim 5 and further recites: the breast pump system of claim 5, wherein the cyclic waveform generator generates a cyclic pump waveform and a cyclic valve waveform, thereby to implement a cycle with four phases in sequence: a first phase comprising the first configuration and with the pump generating a negative pressure; a second phase comprising the second configuration; a third phase comprising the third configuration and with the pump generating a negative pressure; a fourth phase comprising the second configuration.
Base rejection incorporated.
The rejection of claim 5 is incorporated herein.
wherein the cyclic waveform generator generates a cyclic pump waveform and a cyclic valve waveform, thereby to implement a cycle with four phases in sequence: a first phase comprising the first configuration and with the pump generating a negative pressure; a second phase comprising the second configuration; a third phase comprising the third configuration and with the pump generating a negative pressure; a fourth phase comprising the second configuration.
Pan discloses alternating cycles but does not expressly disclose the four phases. Aelen ’671 fills this gap by disclosing a four-phase cycle. Specifically, Aelen ’671 discloses: “a first step of creating a vacuum in a first expression kit and releasing a vacuum in a second expression kit… a second step of turning the situation around by first establishing a short circuit between the first expression kit and the second expression kit… a third step of further releasing the vacuum in the first expression kit and further creating a vacuum in the second expression kit… and a fourth step of turning the situation around again by first establishing a short circuit between the first expression kit and the second expression kit”. (Aelen ‘671, page 7, lines 19-28).
Motivation to combine.
Aelen ’671 provides the motivation to use this four-phase cycle to reuse energy from one expression kit in another to “obtain steeper pressure profiles” and increase the lifetime of the battery. (Aelen ’671, page 4, lines 31-31 and page line 3).
In relation to claim 7, this claim depends from claim 6 and further recites: the breast pump system of claim 6, wherein the pump is turned off in the second and fourth phases.
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
wherein the pump is turned off in the second and fourth phases.
Pan does not expressly disclose turning off the pump during equalization. Aelen ’671 fills this gap by disclosing adjusting pressures without needing to address the pump in the second and fourth phases. Specifically, Aelen ’671 discloses: “the pressures prevailing in the expression kits 2, 3 are automatically adjusted without needing to address the pump 61”. (Aelen ’671, page 14, lines 23-25).
Motivation to combine.
It would have been obvious to turn the pump off during these phases when it is not needed to conserve energy and reduce noise, as taught by Aelen ’671 which notes the goal is to “reduce consumption of electric energy.” (Aelen ’671, page 3, line 10).
In relation to claim 8, this claim depends from claim 3 and further recites: the breast pump system of claim 3, comprising a first actuator for actuating a first three-port valve of the first valve unit and a first three-port valve of the second valve unit, and a second actuator for actuating a second three-port valve of the first valve unit and a second three- port valve of the second valve unit.
Base rejection incorporated.
The rejection of claim 3 is incorporated herein.
comprising a first actuator for actuating a first three-port valve of the first valve unit and a first three-port valve of the second valve unit, and a second actuator for actuating a second three-port valve of the first valve unit and a second three-port valve of the second valve unit.
Pan discloses actuators but does not expressly disclose this combined arrangement. Aelen ’671 fills this gap by disclosing combining switching mechanisms into single units. Specifically, Aelen ’671 discloses: “the first suction switching mechanism and the second suction switching mechanism are combined in a single unit such as a single solenoid with two connections.” (Aelen ’671, page 6, lines 5-7).
Motivation to combine.
Aelen ’671 provides the motivation to combine actuators to achieve “compactness of design”. (Aelen ’671, page 6, line 4).
In relation to claim 9, this claim depends from claim 8 and further recites: The breast pump system of claim 8, wherein: the first three-port valve of the first valve unit has a connection to the first kit, a connection to the first three-port valve of the second valve unit and a connection to the second three-port valve of the first valve unit; the second three-port valve of the first valve unit has a connection to the ambient pressure, a connection to the pump and a connection to the first three-port valve of the first valve unit; the first three-port valve of the second valve unit has a connection to the second kit or buffer, a connection to the first three-port valve of the first valve unit and a connection to the second three-port valve of the second valve unit; and the second three-port valve of the second valve unit has a connection to the ambient pressure, a connection to the pump and a connection to the first three-port valve of the second valve unit.
Base rejection incorporated.
The rejection of claim 8 is incorporated herein.
wherein: the first three-port valve of the first valve unit has a connection to the first kit, a connection to the first three-port valve of the second valve unit and a connection to the second three-port valve of the first valve unit; the second three-port valve of the first valve unit has a connection to the ambient pressure, a connection to the pump and a connection to the first three-port valve of the first valve unit; the first three-port valve of the second valve unit has a connection to the second kit or buffer, a connection to the first three-port valve of the first valve unit and a connection to the second three-port valve of the second valve unit; and the second three-port valve of the second valve unit has a connection to the ambient pressure, a connection to the pump and a connection to the first three-port valve of the second valve unit.]
Pan discloses valve connections but not this specific topology. Aelen ’671 fills this gap by disclosing an arrangement of connections that allows these fluid pathways. Specifically, Aelen ’671 discloses: “the first air conduit is connectable to and disconnectable from a suction side of the pump… the first air conduit and the second air conduit are connectable to and disconnectable from each other directly through an intermediate switching mechanism”. (Aelen ’671, page 3, line 19 to page 4, line 2). It would have been obvious to a person of ordinary skill in the art to arrange the connections of the three-port valves to achieve the exact fluid pathways required for the four-phase cycle.
Motivation to combine.
It would have been obvious to arrange the connections in this specific manner to implement the pressure equalization and alternating suction cycles described in Aelen ’671.
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)(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 11 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Aelen et al. (WO 20200007671A1; hereinafter “Aelen '671”).
In relation to independent claim 11, this claim recites:
a method of controlling a breast pump system for the non-therapeutic expression of milk, wherein the breast pump system has a first kit (30), a second kit (32), a pump (16) for delivering a negative pressure and a valve arrangement which selectively provides an interconnection between the pump, the ambient pressure, the first kit and the second kit, wherein the method comprises: controlling a single pump to generate a negative pressure; controlling the single pump and the valve arrangement to apply a negative pressure to the first kit and equalize a pressure level between the first kit and second kit, by: controlling a first valve unit (40) connected between the first kit (30) and the pump (16) and a second valve unit (42) connected between the second kit (32) and the pump (16) or the first valve unit (40), wherein the first and second valve units (40,42) are controlled to connect the first kit to a selected one of the pump, the ambient pressure and the second kit, and wherein the method comprises controlling each of the first and second valve units (40, 42) with a single respective valve actuator, characterized in that the method comprises controlling the pump to generate the negative pressure with a cyclic pump waveform and controlling the valve arrangement to apply the negative pressure to the first kit and to the second kit in an alternating sequence using a cyclic valve waveform, and
in that the method comprises implementing a cycle with four phases in sequence: a first phase with a negative pressure coupled to the first kit and the second kit vented to the ambient pressure; a second phase with the first kit and second kit coupled together a third phase with a negative pressure coupled to the second kit and the first kit vented to the ambient pressure; and a fourth phase with the first kit and second kit coupled together.
A method of controlling a breast pump system for the non-therapeutic expression of milk, wherein the breast pump system has a first kit (30), a second kit (32), a pump (16) for delivering a negative pressure and a valve arrangement which selectively provides an interconnection between the pump, the ambient pressure, the first kit and the second kit, wherein the method comprises: controlling a single pump to generate a negative pressure; controlling the single pump and the valve arrangement to apply a negative pressure to the first kit and equalize a pressure level between the first kit and second kit, by: controlling a first valve unit (40) connected between the first kit (30) and the pump (16) and a second valve unit (42) connected between the second kit (32) and the pump (16) or the first valve unit (40), wherein the first and second valve units (40,42) are controlled to connect the first kit to a selected one of the pump, the ambient pressure and the second kit, and wherein the method comprises controlling each of the first and second valve units (40, 42) with a single respective valve actuator, characterized in that the method comprises controlling the pump to generate the negative pressure with a cyclic pump waveform and controlling the valve arrangement to apply the negative pressure to the first kit and to the second kit in an alternating sequence using a cyclic valve waveform,
Aelen '671 discloses a method of operating a pump arrangement for a double breast pump with these features. Specifically, Aelen '671 discloses: "a method of operating a pump arrangement of a double breast pump device comprising two expression kits... the pump arrangement comprising a pump configured to create the pressure profile in the expression kits, and a first air conduit and a second air conduit... the first air conduit and the second air conduit being connectable to and disconnectable from each other directly at a bypass position with respect to the pump". (Aelen '671, claim 14). Furthermore, Aelen '671 discloses "the first suction switching mechanism and the second suction switching mechanism are combined in a single unit such as a single solenoid with two connections." (Aelen '671, page 6, lines 5-7).
and in that the method comprises implementing a cycle with four phases in sequence: a first phase with a negative pressure coupled to the first kit and the second kit vented to the ambient pressure; a second phase with the first kit and second kit coupled together a third phase with a negative pressure coupled to the second kit and the first kit vented to the ambient pressure; and a fourth phase with the first kit and second kit coupled together.
Aelen '671 discloses this exact four-phase sequence. Specifically, Aelen ’671 discloses: “a first step of creating a vacuum in a first expression kit and releasing a vacuum in a second expression kit… a second step of turning the situation around by first establishing a short circuit between the first expression kit and the second expression kit… a third step of further releasing the vacuum in the first expression kit and further creating a vacuum in the second expression kit… and a fourth step of turning the situation around again by first establishing a short circuit between the first expression kit and the second expression kit”. (Aelen ’671, page 7, lines 19-28).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Aelen et al. (WO2020007671A1; hereinafter “Aelen ‘671”) in view of Pan (US 10,857,270B2).
In relation to claim 12, this claim depends from claim 11 and further recites: A computer program comprising computer program code means which is adapted, when said program is run on a controller of a breast pump system, to implement the method of claim 11.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
A computer program comprising computer program code means which is adapted,
when said program is run on a controller of a breast pump system, to implement the
method of claim 11.
Aelen ’671 discloses implementing the method using a controller configured to execute the repetitive algorithm. Specifically, Aelen ’671 discloses: “a controller that is configured to control operation of the pump arrangement according to the following repetitive algorithm of successive steps”. (Aelen, page 6, lines 11-14). However, Aelen ’671 does not expressly claim the algorithm as a computer program code means on a storage medium. To the extent Aelen ’671 does not expressly disclose this enhancement, Pan fills this gap by disclosing a computer program for a breast pump method. Specifically, Pan discloses: “A computer-readable storage medium that is not a transitory propagating signal or wave, the medium containing control information for controlling the method for operating the pump arrangement… where said control information is carried out on a computer.” (Pan, claim 21).
Motivation to combine.
It would have been obvious to combine Aelen ’671 with Pan because both references relate to double breast pump control methods. A person of ordinary skill in the art would have been motivated to implement the repetitive algorithm disclosed in Aelen ’671 using a computer program run on a controller as taught by Pan because software-based controllers are standard for implementing complex, multi-phase repetitive control algorithms in electromechanical devices.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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