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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 11, 2026 has been entered.
Claims 1, 3, and 5-20 remain pending in the application. Claims 2 and 4 were previously cancelled.
Claim Objections
Claim 1 is objected to because there is a lack of antecedent basis for “the expression process” in line 12. Appropriate correction is required.
Claim 9 is objected to because there is a lack of antecedent basis for “the top” in line 2. Appropriate correction is required.
Claim 11 is objected to because there appears to be a typo regarding “a signal evaluation module” in line 2 as opposed to “the signal evaluation module”. The limitation “a signal evaluation module” was previously introduced in claim 1. Appropriate correction is required.
Claim 15 is objected to because there appears to be a typo regarding “a sensor unit” in line 6 as opposed to “the sensor unit”. The limitation “a sensor unit” was previously introduced in line 1 of the claim. Appropriate correction is required.
Claim 15 is further objected to because the limitation “this part of the milk channel” in line 6 should be corrected to “the part of the milk channel”. Appropriate correction is required.
Claim 15 is further objected to because there is a lack of antecedent basis for “the expression process” in lines 11-12 and “the breastshield unit” in line 13. Appropriate correction is required.
Claim 16 is objected to because there is a lack of antecedent basis for “the direction of flow” in line 6. Appropriate correction is required.
Claim 16 is further objected to because there is a lack of antecedent basis for “the at least one sensor” in line 8. The limitation “at least one sensor” is not introduced until line 12 of the claim. Appropriate correction is required.
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, 3, 5-11, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Furrer et al. (US 20150328380) in view of Makower et al. (USPN 10561770) in further view of Dietz et al. (USPN 5483830).
Regarding claim 1, Furrer discloses a breastshield unit of a breast pump for expressing human breastmilk (Figures 9 and 10), wherein the breastshield unit comprises a breastshield (breastshield 2) for placing onto a human breast (Figure 5), a milk collection container (milk collection container 5) for receiving expressed breastmilk, a breastshield adapter (milk attachment part 28) for connecting the breastshield to the milk collection container (“The breastshield 2 once again has the dimensionally stable, preferably stiff main body 25 with a milk attachment part 28 for securing on the milk collection container 5.” [0028]), and a milk channel (milk channel 251) that extends from the breastshield through the breastshield adapter into the milk collection container, wherein the milk channel defines a direction of flow of the breastmilk (“The milk flow path or milk channel 251 leads from the through-opening 36 to the milk collection container 5.” [0070]; Figures 9-10), wherein a valve (check valve 91) is present which closes and opens the milk channel during the expression process (“This milk channel 251 can preferably be closed by a check valve 91” [0070]), wherein the milk channel is arranged downstream from the valve in the direction of flow of the breastmilk (Figures 9-10).
Furrer fails to explicitly disclose at least one sensor for detecting the breastmilk within the milk channel, wherein a siphon is arranged in the milk channel, the siphon comprising a first siphon bend forming a damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, wherein the at least one sensor for detecting the breastmilk is arranged within the milk channel and downstream from the siphon in the direction of flow of the breastmilk, wherein the siphon in the milk channel is arranged downstream from the valve in the direction of flow of the breastmilk, and wherein the breastshield unit comprises a signal evaluation module for evaluating signals of the at least one sensor, the signal evaluation module suppling a profile of the signals as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, and fat content.
Makower teaches a breastshield unit of a breast pump (breast pump system 100; Figure 5A), wherein the breastshield unit comprising a breastshield (breast adapter 10), a milk collection container (milk storage container 60), and at least one sensor (pressure sensor 54) for detecting the breastmilk within a milk channel (resilient tube 32), wherein the at least one sensor for detecting the breastmilk is arranged within the milk channel (“The pressure sensor 54 (and/or flow sensor or any other sensor employed)—may be inserted into the tube 32” [Col 13, lines 9-11]) and downstream from a valve (one-way valve 50”; “one or more additional pressure sensors could be further included downstream of this location, including, but not limited to: distal of region 40, in between regions 40 and 42, proximal of region 42, but adjacent thereto, and/or distally adjacent one-way valve 50.” [Col 41, lines 10-14]), and wherein the breastshield unit comprises a signal evaluation module (controller 52) for evaluating signals of the at least one sensor, the signal evaluation module suppling a profile of the signals as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, and fat content (“the pressure sensor signals received by controller 52 from pressure sensor 54 can be used to plot pressure/suction (vacuum) waveforms applied by the system 100 during operation. Additionally, pressure sensor 54 signals can be used to determine when milk flow initiates, as well as the rate and/or volume of milk flow based on pressure changes resulting from milk being present in the adapter 10 and/or tube 32.” [Col 39, lines 38-45]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the breastshield unit of Furrer to include at least one sensor arranged within the milk channel and a signal evaluation module for evaluating signals of the at least one sensor, the signal evaluation module suppling a profile of the signals as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, and fat content based on the teachings of Makower to assess the functionality of the breast pump and monitor and approximate the amount milk collected (Makower [Col 12, lines 60-67]; [Col 14, lines 20-23]).
Modified Furrer fails to explicitly disclose a siphon is arranged in the milk channel, the siphon comprising a first siphon bend forming a damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, wherein the at least one sensor is arranged downstream from the siphon in the direction of flow of the breastmilk, wherein the siphon in the milk channel is arranged downstream from the valve in the direction of flow of the breastmilk.
Dietz teaches a fluid collection device (bladder catheter through siphon unit 10 to micturition bag) comprising at least one sensor for detecting fluid within a fluid channel (“This emptying is measured by means of a not shown reflected light barrier, preferably located in the vicinity of the measuring chamber 14 or optionally in the outflow duct.” [Col 7, lines 60-63]), wherein a siphon (siphon 20) is arranged in the fluid channel (Figure 1), the siphon comprising a first siphon bend (from bottom level 19 towards rising portion of siphon 20; Figure 1) forming a damming region upstream of the at least one sensor and a second siphon bend (upper overflow edge 22) upstream of the at least one sensor (Figure 1), wherein the at least one sensor is arranged downstream from the siphon in the direction of flow of the fluid (“This emptying is measured by means of a not shown reflected light barrier,… optionally in the outflow duct.” [Col 7, lines 60-63]), wherein the siphon in the fluid channel is arranged downstream from an entrance into the milk channel (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the breastshield unit of Furrer as modified by Makower to include a siphon comprising a first siphon bend forming a damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, wherein the at least one sensor is arranged downstream from the siphon in the direction of flow of the breastmilk, wherein the siphon in the milk channel is arranged downstream from the valve in the direction of flow of the breastmilk based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk (Dietz [Col 7, lines 47-67]).
Regarding claim 3, modified Furrer discloses the breastshield unit according to Claim 1, wherein the milk channel comprises a widened region (portion of milk channel 251 closest to receiving area 33) between the valve and the siphon.
Regarding claim 5, modified Furrer discloses the breastshield unit according to Claim 1.
Modified Furrer fails to explicitly disclose a sensor unit is present, wherein the sensor unit comprises the siphon of the milk channel and the at least one sensor.
Dietz teaches a fluid collection device (bladder catheter through siphon unit 10 to micturition bag) wherein a sensor unit (siphon unit 10) is present, wherein the sensor unit comprises the siphon of the milk channel (siphon 20) and the at least one sensor (“This emptying is measured by means of a not shown reflected light barrier” [Col 7, lines 60-62]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the breastshield unit of Furrer as modified by Makower to include a sensor unit comprising the siphon at the at least one sensor based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk (Dietz [Col 7, lines 47-67]).
Regarding claim 6, modified Furrer discloses the breastshield unit according to Claim 5.
Modified Furrer fails to explicitly disclose wherein the sensor unit comprises a main body with a surface and with a cover tightly closing this surface, wherein at least the siphon of the milk channel is formed by a groove which is configured in at least one of the surface and the cover and which, by the cooperation of the surface with the cover, is tightly closed except for an inlet and an outlet.
Dietz teaches a fluid collection device (bladder catheter through siphon unit 10 to micturition bag) comprising a sensor unit (siphon unit 10) comprising the siphon of the milk channel (siphon 20) and the at least one sensor (“This emptying is measured by means of a not shown reflected light barrier” [Col 7, lines 60-62]), wherein the sensor unit comprises a main body (first half of siphon unit 10) with a surface (inner surface of first half of siphon unit 10) and with a cover (second half of siphon unit 10) tightly closing this surface (“said siphon unit 10 comprises two half-blocks constructed in homologous manner to the central sectional plane and which can e.g. be sealingly screwed together” [Col 7, line 27-29]), wherein at least the siphon of the milk channel is formed by a groove which is configured in at least one of the surface and the cover (Figure 2; “contours of the siphon unit 10” [Col 7, line 31]), and which by the cooperation of the surface with the cover, is tightly closed except for an inlet (filling duct 16) and an outlet (outflow duct 26; Figure 2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the breastshield unit of Furrer as modified by Makower to include a sensor unit comprising a main body with a surface and with a cover tightly closing this surface, wherein at least the siphon of the milk channel is formed by a groove which is configured in at least one of the surface and the cover and which, by the cooperation of the surface with the cover, is tightly closed except for an inlet and an outlet based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk using a simplified manufacturing process (Dietz [Col 7, lines 27-31 and 47-67]).
Regarding claims 7-8, modified Furrer discloses the breastshield unit according to Claim 6.
Modified Furrer fails to explicitly disclose the surface is a radially outwardly oriented surface of the main body, as required by claim 7; and wherein the cover is one of a lid or a sleeve, as required by claim 8.
Dietz teaches a fluid collection device (bladder catheter through siphon unit 10 to micturition bag) comprising a sensor unit (siphon unit 10) comprising the siphon of the milk channel (siphon 20) and the at least one sensor (“This emptying is measured by means of a not shown reflected light barrier” [Col 7, lines 60-62]), wherein the sensor unit comprises a main body (first half of siphon unit 10) with a radially outwardly oriented surface (inner surface of first half of siphon unit 10, extending radially outward from siphon 20) and with a cover (second half of siphon unit 10) that is a lid (“said siphon unit 10 comprises two half-blocks constructed in homologous manner to the central sectional plane and which can e.g. be sealingly screwed together” [Col 7, line 27-29]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the breastshield unit of Furrer as modified by Makower to include a sensor unit comprising a main body with a radially outward oriented surface and with a cover that is a lid tightly closing this surface based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk using a simplified manufacturing process (Dietz [Col 7, lines 27-31 and 47-67]).
Regarding claim 9, modified Furrer discloses the breastshield unit according to Claim 6.
Modified Furrer fails to explicitly disclose the sensor unit comprises an interior which is open at the top and in which the surface is formed in an undulating shape, and wherein the cover is configured as an undulating counterpart.
Dietz teaches a fluid collection device (bladder catheter through siphon unit 10 to micturition bag) comprising a sensor unit (siphon unit 10) comprising the siphon of the milk channel (siphon 20) and the at least one sensor (“This emptying is measured by means of a not shown reflected light barrier” [Col 7, lines 60-62]), wherein the sensor unit comprises a main body (first half of siphon unit 10) with a surface (inner surface of first half of siphon unit 10) and with a cover (second half of siphon unit 10); wherein the sensor unit comprises an interior (Figures 1 and 2) which is open at the top (at filling duct 16) and in which the surface is formed in an undulating shape (“contours of the siphon unit 10” on first half of siphon unit 10 [Col 7, line 31]), and wherein the cover is configured as an undulating counterpart (Figure 2; “said siphon unit 10 comprises two half-blocks constructed in homologous manner to the central sectional plane and which can e.g. be sealingly screwed together” [Col 7, line 27-29]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the breastshield unit of Furrer as modified by Makower to include a sensor unit comprising an interior which is open at the top and in which the surface is formed in an undulating shape, and wherein the cover is configured as an undulating counterpart based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk using a simplified manufacturing process (Dietz [Col 7, lines 27-31 and 47-67]).
Regarding claims 10-11, modified Furrer discloses the breastshield unit according to Claim 6.
Modified Furrer fails to explicitly disclose the main body comprises a cavity for receiving an electronics unit, as required by claim 10; and wherein the electronics unit comprises a signal evaluation module, as required by claim 11.
Makower teaches a breastshield unit of a breast pump (breast pump system 100; Figure 5A), wherein the breastshield unit comprising a breastshield (breast adapter 10), a milk collection container (milk storage container 60), and a sensor unit (pumping region 30 within housing 34) comprising a siphon of the milk channel (through resilient tube 32) and the at least one sensor (“The pressure sensor 54 (and/or flow sensor or any other sensor employed)—may be inserted into the tube 32” [Col 13, lines 9-11]; Figure 3) wherein the sensor unit comprises a main body (housing 34) comprising a cavity (Figure 3, within housing 34) for receiving an electronics unit (drivers 44, 46, battery 48, controller 52) comprising a signal evaluation module (controller 52; Figure 3).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the breastshield unit of Furrer to include at the main body comprises a cavity for receiving an electronics unit comprising a signal evaluation module based on the teachings of Makower to assess the functionality of the breast pump and monitor and approximate the amount milk collected (Makower [Col 12, lines 60-67]; [Col 14, lines 20-23]).
Regarding claim 13, modified Furrer discloses the breastshield unit according to Claim 1.
Modified Furrer fails to explicitly disclose the at least one sensor is at least one optical sensor.
Makower teaches a breastshield unit of a breast pump (breast pump system 100; Figure 5A), wherein the breastshield unit comprising a breastshield (breast adapter 10), a milk collection container (milk storage container 60), and at least one sensor that is an optical sensor (“a flow sensor or optical sensor may be employed to provide an estimate of volume and/or measurement of the extent of filling of tube 32 in a predefined region of the tube 32 to help in estimating the volume of milk pumped.” [Col 18, lines 58-61]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the breastshield unit of Furrer to include at least one optical sensor based on the teachings of Makower to estimate the volume of the mill collected (Makower [Col 18, lines 58-61]).
Regarding claim 14, modified Furrer discloses the breastshield unit according to Claim 1.
Modified Furrer fails to explicitly disclose more than one sensor is present, and wherein different sensors are present.
Makower teaches a breastshield unit of a breast pump (breast pump system 100; Figure 5A), wherein the breastshield unit comprising a breastshield (breast adapter 10), a milk collection container (milk storage container 60), and more than one sensor is present (“in addition to the placement of the pressure sensor 54 in the breast adapter as illustrated in FIG. 2, one or more additional pressure sensors could be further included downstream of this location” [Col 41, lines 8-11]), and wherein different sensors are present (“The pressure sensor 54 (and/or flow sensor or any other sensor employed)—may be inserted into the tube 32” [Col ]; “a flow sensor or optical sensor may be employed to provide an estimate of volume and/or measurement of the extent of filling of tube 32 in a predefined region of the tube 32 to help in estimating the volume of milk pumped.” [Col 18, lines 58-61]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the breastshield unit of Furrer to both assess the functionality of the breast pump and monitor and approximate the amount milk collected (Makower [Col 12, lines 60-67]; [Col 14, lines 20-23]; [Col 18, lines 58-61]).
Regarding claim 15, Furrer discloses a unit of a breast pump for expressing human breastmilk (Figures 9 and 10), wherein the breast pump comprises a breastshield (breastshield 2) for placing onto a human breast (Figure 5), a milk collection container (milk collection container 5) for receiving expressed breastmilk, a milk channel (milk channel 251) extending from the breastshield to the milk collection container (“The milk flow path or milk channel 251 leads from the through-opening 36 to the milk collection container 5.” [0070]; Figures 9-10), wherein a valve (check valve 91) is present which closes and opens the milk channel during the expression process (“This milk channel 251 can preferably be closed by a check valve 91” [0070]), wherein the milk channel is arranged downstream from the valve in the direction of flow of the breastmilk (Figures 9-10).
Furrer fails to explicitly disclose a sensor unit of a breast pump, the breast pump comprising at least one sensor for detecting the breastmilk within the milk channel, a sensor unit comprising a part of the milk channel, wherein this part of the milk channel forms a siphon, the siphon comprising a first siphon bend forming a damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, and the at least one sensor for detecting the breastmilk being arranged in the sensor unit, within the milk channel, and downstream from the siphon in the direction of flow of the breastmilk, wherein the siphon in the milk channel is arranged downstream from the valve in the direction of flow of the breastmilk, and wherein the breastshield unit comprises a signal evaluation module for evaluating signals of the at least one sensor, the signal evaluation module suppling a profile of the signals as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, and fat content.
Makower teaches a sensor unit (pumping region 30 within housing 34) of a breast pump (breast pump system 100; Figure 5A), wherein the breast pump comprises a breastshield (breast adapter 10), a milk collection container (milk storage container 60), a milk channel (resilient tube 32), and at least one sensor (pressure sensor 54) for detecting the breastmilk within a milk channel (resilient tube 32), a sensor unit (pumping region 30 within housing 34) comprising a part of the milk channel (Figure 3) and the at least one sensor for detecting the breastmilk being arranged in the sensor unit, within the milk channel (“The pressure sensor 54 (and/or flow sensor or any other sensor employed)—may be inserted into the tube 32” [Col 13, lines 9-11]; Figure 3) and downstream from a valve (one-way valve 50”; “one or more additional pressure sensors could be further included downstream of this location, including, but not limited to: distal of region 40, in between regions 40 and 42, proximal of region 42, but adjacent thereto, and/or distally adjacent one-way valve 50.” [Col 41, lines 10-14]), and wherein the breastshield unit comprises a signal evaluation module (controller 52) for evaluating signals of the at least one sensor, the signal evaluation module suppling a profile of the signals as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, and fat content (“the pressure sensor signals received by controller 52 from pressure sensor 54 can be used to plot pressure/suction (vacuum) waveforms applied by the system 100 during operation. Additionally, pressure sensor 54 signals can be used to determine when milk flow initiates, as well as the rate and/or volume of milk flow based on pressure changes resulting from milk being present in the adapter 10 and/or tube 32.” [Col 39, lines 38-45]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the unit of Furrer to be a sensor unit comprising at least one sensor for detecting breastmilk within the milk channel, the sensor unit comprising a part of the milk channel, the at least one sensor arranged within the milk channel and a signal evaluation module for evaluating signals of the at least one sensor, the signal evaluation module suppling a profile of the signals as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, and fat content based on the teachings of Makower to assess the functionality of the breast pump and monitor and approximate the amount milk collected (Makower [Col 12, lines 60-67]; [Col 14, lines 20-23]).
Modified Furrer fails to explicitly disclose a siphon is arranged in the milk channel, the siphon comprising a first siphon bend forming a damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, wherein the at least one sensor is arranged downstream from the siphon in the direction of flow of the breastmilk, wherein the siphon in the milk channel is arranged downstream from the valve in the direction of flow of the breastmilk.
Modified Furrer fails to explicitly disclose the part of the milk channel forms a siphon, the siphon comprising a first siphon bend forming a damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, and the at least one sensor for detecting the breastmilk being arranged in the sensor unit, downstream from the siphon in the direction of flow of the breastmilk, wherein the siphon in the milk channel is arranged downstream from the valve in the direction of flow of the breastmilk.
Dietz teaches a sensor unit (siphon unit 10) for a fluid collection device (bladder catheter through siphon unit 10 to micturition bag) comprising at least one sensor for detecting fluid within a fluid channel (“This emptying is measured by means of a not shown reflected light barrier, preferably located in the vicinity of the measuring chamber 14 or optionally in the outflow duct.” [Col 7, lines 60-63]), wherein a siphon (siphon 20) is arranged in the fluid channel (Figure 1), the siphon comprising a first siphon bend (from bottom level 19 towards rising portion of siphon 20; Figure 1) forming a damming region upstream of the at least one sensor and a second siphon bend (upper overflow edge 22) upstream of the at least one sensor (Figure 1), wherein the at least one sensor is arranged downstream from the siphon in the direction of flow of the fluid (“This emptying is measured by means of a not shown reflected light barrier,… optionally in the outflow duct.” [Col 7, lines 60-63]), wherein the siphon in the fluid channel is arranged downstream from an entrance into the milk channel (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the breastshield unit of Furrer as modified by Makower to include the part of the milk channel forms a siphon, the siphon comprising a first siphon bend forming a damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, and the at least one sensor for detecting the breastmilk being arranged in the sensor unit, downstream from the siphon in the direction of flow of the breastmilk, wherein the siphon in the milk channel is arranged downstream from the valve in the direction of flow of the breastmilk based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk (Dietz [Col 7, lines 47-67]).
Regarding claim 16, Furrer discloses a method during expression of the human breastmilk, wherein the breastmilk is expressed by application of a changing negative pressure (via vacuum channel 250; see [0011]), wherein the method comprises: collecting the breastmilk through a valve (check valve 91) which closes and opens a milk channel (milk channel 251) during the expression of the human breastmilk (“The milk flow path or milk channel 251 leads from the through-opening 36 to the milk collection container 5. It is deflected laterally on account of the media separation membrane 9 and extends, preferably in the area near the breast, to the side of the pump chamber 90. In doing so, it preferably extends through the lowest point of the media separation membrane in the position of use, so that no milk remains lying on the membrane. This milk channel 251 can preferably be closed by a check valve 91.” [0070]) .
Furrer fails to explicitly disclose the method for determining at least one property of human breastmilk during expression of the human breastmilk, wherein the method comprises: collecting the breastmilk in a damming region of a siphon region arranged downstream from the valve in the direction of flow of the breastmilk, the siphon region comprising a first siphon bend forming the damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, emptying the damming region batch by batch via a siphon loop of the siphon region to form a breastmilk column, forwarding the breastmilk column to at least one sensor arranged in the milk channel, detecting the breastmilk column within the milk channel, which has been forwarded batch by batch, by means of the at least one sensor, and evaluating signals of the sensor as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, and fat content.
Makower teaches a method for determining at least one property of human breastmilk during expression of the human breastmilk (“the pressure sensor signals received by controller 52 from pressure sensor 54 can be used to plot pressure/suction (vacuum) waveforms applied by the system 100 during operation. Additionally, pressure sensor 54 signals can be used to determine when milk flow initiates, as well as the rate and/or volume of milk flow based on pressure changes resulting from milk being present in the adapter 10 and/or tube 32.” [Col 39, lines 38-45]), wherein the method comprises: collecting the breastmilk through a valve (second one-way valve 50”) which closes and opens a milk channel (resilient tube 32) in a damming region (compressible region 42) arranged downstream from the valve in the direction of flow of the breastmilk (Figure 5A; “In FIG. 5C, as compression element 38 is retracted away from tube 32, tube 32 resiliently expands to increase vacuum (drop the pressure) in tube 32. This closes the one-way valve 50′ and opens the one-way valve 50″ to extract milk from the breast 2 and into the region 42.” [Col 19, line 17-21]), emptying the damming region batch by batch to form a breastmilk column and forwarding the breastmilk column (“After a seal of the system 100 to the breast 2 is accomplished in any of the manners described previously, and letdown has occurred, pumping of expressed milk can be performed by compressing region 42 with compression element 38 as illustrated in FIG. 5B. As the pressure increases due to the compression of region 42, milk is driven through one-way valve 50′ as indicated by the leftward directed arrow in FIG. 5B.” [Col 19, line 8-12]) to at least one sensor (pressure sensor 54) arranged in the milk channel (“The pressure sensor 54 (and/or flow sensor or any other sensor employed)—may be inserted into the tube 32” [Col 13, lines 9-11]; “one or more additional pressure sensors could be further included downstream of this location, including, but not limited to:…proximal of region 42, but adjacent thereto, and/or distally adjacent one-way valve 50.” [Col 41, lines 10-14]), detecting the breastmilk column within the milk channel, which has been forwarded batch by batch, by means of the at least one sensor, evaluating signals of the sensor as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, and fat content (“the pressure sensor signals received by controller 52 from pressure sensor 54 can be used to plot pressure/suction (vacuum) waveforms applied by the system 100 during operation. Additionally, pressure sensor 54 signals can be used to determine when milk flow initiates, as well as the rate and/or volume of milk flow based on pressure changes resulting from milk being present in the adapter 10 and/or tube 32.” [Col 39, lines 38-45]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Furrer to be for determining at least one property of human breastmilk during expression of the human breastmilk, wherein the method comprises: collecting the breastmilk in a damming region arranged downstream from the valve in the direction of flow of the breastmilk, emptying the damming region batch by batch to form a breastmilk column, forwarding the breastmilk column to at least one sensor arranged in the milk channel, detecting the breastmilk column within the milk channel, which has been forwarded batch by batch, by means of the at least one sensor, and evaluating signals of the sensor as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity, macronutrients, and fat content based on the teachings of Makower to assess the functionality of the breast pump and monitor and approximate the amount milk collected (Makower [Col 12, lines 60-67]; [Col 14, lines 20-23]).
Modified Furrer fails to explicitly disclose the method comprises: collecting the breastmilk in a damming region of a siphon region, the siphon region comprising a first siphon bend forming the damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, and emptying the damming region batch by batch via a siphon loop of the siphon region to form the breastmilk column.
Dietz teaches a method for determining a property of a fluid (“a signal is obtained for each emptying cycle and as a result of the clearly defined filling volume of the measuring chamber provides precise information on the flow rate through the sensor 10 constructed as a siphon unit.” [Col 7, lines 64-67]), wherein the method comprises collecting a fluid flowing through a fluid channel (measuring chamber 14) in a damming region of a siphon region (siphon 20; “By means of the filling duct 16 the measuring chamber 14 is filled with liquid in the retention area of the siphon unit 10 in accordance with the liquid flow to be measured, the liquid rising in the siphon 20.” [Col 4, lines 48-51]), the siphon region comprising a first siphon bend (from bottom level 19 towards rising portion of siphon 20; Figure 1) forming the damming region upstream of at least one sensor (“This emptying is measured by means of a not shown reflected light barrier, preferably located…in the outflow duct.” [Col 7, lines 60-63]) and a second siphon bend (upper overflow edge 22) upstream of the at least one sensor (Figure 1), emptying the damming region batch by batch via a siphon loop of the siphon region to form a fluid column, forwarding the fluid column to at least one sensor arranged in the milk channel, detecting the fluid column within the milk channel, which has been forwarded batch by batch, by means of the at least one sensor (“By means of the filling duct 16 the measuring chamber 14 is filled with liquid in the retention area of the siphon unit 10 in accordance with the liquid flow to be measured, the liquid rising in the siphon 20. The liquid rises corresponding to the filling level in the measuring chamber 14 to above the upper overflow edge 22 of the siphon 20 and at the diameter jump 24 forms a liquid membrane. In the case of further liquid rising in the measuring chamber 14, for a clearly defined filling level, the surface tension of the liquid membrane at the diameter jump 24 is exceeded and all the liquid in the measuring chamber 14 is, as a result of its cohesive effect, abruptly and substantially completely emptied through the siphon 20 and the outflow duct 26. This emptying is measured by means of a not shown reflected light barrier, preferably located in the vicinity of the measuring chamber 14 or optionally in the outflow duct. Thus, a signal is obtained for each emptying cycle and as a result of the clearly defined filling volume of the measuring chamber provides precise information on the flow rate through the sensor 10 constructed as a siphon unit.” [Col 7, lines 48-67]), and evaluating signals of the sensor as a function of time, as a result of which at least one of the following variables can be determined: throughflow quantity, throughflow rate, throughflow velocity (“FIG. 11 shows the electronic principle of the detector means 70, which contains corresponding correlation means for eliminating inclination or through-flow divergences. The microprocessor 71 receives signals via the measuring section block 73 with respect to the number of through-flowing measuring volumes and as a result the flow rate can also be determined” [Col 10, liens 22-28).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Furrer as modified by Makower to include collecting the breastmilk in a damming region of a siphon region, the siphon region comprising a first siphon bend forming the damming region upstream of the at least one sensor and a second siphon bend upstream of the at least one sensor, and emptying the damming region batch by batch via a siphon loop of the siphon region to form the breastmilk column based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk (Dietz [Col 7, lines 47-67]).
Regarding claim 17, modified Furrer discloses the breastshield unit according to claim 5.
Modified Furrer fails to explicitly disclose the sensor unit is arranged between the breastshield adapter and the milk collection container.
Makower teaches a breastshield unit of a breast pump (breast pump system 100; Figure 5A), wherein the breastshield unit comprising a breastshield adapter (breast adapter 10), a milk collection container (milk storage container 60), and a sensor unit (pumping region 30 within housing 34) comprising a siphon of the milk channel (through resilient tube 32) and the at least one sensor (“The pressure sensor 54 (and/or flow sensor or any other sensor employed)—may be inserted into the tube 32” [Col 13, lines 9-11]; Figure 3) wherein the sensor unit is arranged between the breastshield adapter and the milk collection container (Figure 1; “one or more additional pressure sensors could be further included downstream of this location, including, but not limited to: distal of region 40, in between regions 40 and 42, proximal of region 42, but adjacent thereto, and/or distally adjacent one-way valve 50.” [Col 41, lines 10-14]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the breastshield unit of Furrer to include the sensor unit is arranged between the breastshield adapter and the milk collection container based on the teachings of Makower to assess the functionality of the breast pump and monitor and approximate the amount milk collected (Makower [Col 12, lines 60-67]; [Col 14, lines 20-23]).
Regarding claim 18, modified Furrer discloses the breastshield unit according to claim 1.
Modified Furrer fails to explicitly disclose the milk channel has a constant cross section along the first and second siphon bends.
Dietz teaches a fluid collection device (bladder catheter through siphon unit 10 to micturition bag) comprising at least one sensor for detecting fluid within a fluid channel (“This emptying is measured by means of a not shown reflected light barrier, preferably located in the vicinity of the measuring chamber 14 or optionally in the outflow duct.” [Col 7, lines 60-63]), wherein a siphon (siphon 20) is arranged in the fluid channel (Figure 1), the siphon comprising a first siphon bend (from bottom level 19 towards rising portion of siphon 20; Figure 1) and a second siphon bend (upper overflow edge 22), the fluid channel has a constant cross section along the first and second siphon bends (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the breastshield unit of Furrer as modified by Makower to include a siphon arranged in the milk channel, the milk channel having a constant cross section along the first and second siphon bends based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk (Dietz [Col 7, lines 47-67]).
Regarding claim 19, modified Furrer discloses the sensor unit according to claim 1.
Modified Furrer fails to explicitly disclose the milk channel has a constant cross section along the first and second siphon bends.
Dietz teaches a sensor unit (siphon unit 10) for a fluid collection device (bladder catheter through siphon unit 10 to micturition bag) comprising at least one sensor for detecting fluid within a fluid channel (“This emptying is measured by means of a not shown reflected light barrier, preferably located in the vicinity of the measuring chamber 14 or optionally in the outflow duct.” [Col 7, lines 60-63]), wherein a siphon (siphon 20) is arranged in the fluid channel (Figure 1), the siphon comprising a first siphon bend (from bottom level 19 towards rising portion of siphon 20; Figure 1) and a second siphon bend (upper overflow edge 22), the fluid channel has a constant cross section along the first and second siphon bends (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the sensor unit of Furrer as modified by Makower to include a siphon arranged in the milk channel, the milk channel having a constant cross section along the first and second siphon bends based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk (Dietz [Col 7, lines 47-67]).
Regarding claim 20, modified Furrer discloses the method according to claim 16.
Modified Furrer fails to explicitly disclose the milk channel has a constant cross section along the first and second siphon bends.
Dietz teaches a method for determining a property of a fluid (“a signal is obtained for each emptying cycle and as a result of the clearly defined filling volume of the measuring chamber provides precise information on the flow rate through the sensor 10 constructed as a siphon unit.” [Col 7, lines 64-67]), wherein the method comprises collecting a fluid flowing through a fluid channel (measuring chamber 14) in a damming region of a siphon region (siphon 20), the siphon comprising a first siphon bend (from bottom level 19 towards rising portion of siphon 20; Figure 1) and a second siphon bend (upper overflow edge 22), the fluid channel has a constant cross section along the first and second siphon bends (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Furrer as modified by Makower to include a siphon region arranged in the milk channel, the milk channel having a constant cross section along the first and second siphon bends based on the teachings of Dietz to provide a clearly defined volume within a portion of the milk channel, allowing for a precise measurement of the flow rate of the breastmilk (Dietz [Col 7, lines 47-67]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Furrer et al. (US 20150328380) in view of Makower et al. (USPN 10561770) in further view of Dietz et al. (USPN 5483830) as applied in claim 5 above, and further in view of Guthrie et al. (US 20160220743).
Regarding claim 12, modified Furrer discloses the breastshield unit according to Claim 5.
Modified Furrer fails to explicitly disclose the sensor unit has the shape of a circular cylinder or the shape of a truncated cone.
Guthrie teaches a breastshield unit of a breast pump (Figure 8), wherein the breastshield unit comprises a breastshield (flange 801), a milk collection container (capture system 810), and a sensor unit (connection area 808) comprising a milk channel (Figure 8) and at least one sensor (sensors 803, 804), the sensor unit has the shape of a circular cylinder (Figure 8) or the shape of a truncated cone.
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the sensor unit of Furrer as modified by Makower and Dietz to have the shape of a circular cylinder based on the teachings of Furrer to sealingly integrate the sensor unit within the breast pump between the breastshield and the milk collection container (Guthrie Figure 8 and [0049]).
Response to Arguments
Applicant’s arguments, see pages 7-8 of the Remarks filed 03/11/16, with respect to the rejections of claims 1, 3, and 5-17 under 35 USC 112(a) have been fully considered and are persuasive. The rejections under 35 U.S.C. 112(a) of claims 1, 3, and 5-17 have been withdrawn.
Applicant’s arguments with respect to claims 1, 3, and 5-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/LEAH J SWANSON/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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