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
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(s) 1-3 and 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simmons et al. (US 2016/0287767) in view of Ross et al. (5,584,811).
Regarding claim 1, Simmons et al. (henceforth Simmons) discloses a breast pump (110), comprising: a vacuum source (the breast pump runs via a negative pressure pump; e.g., ¶ [0088]); a breast engagement portion in fluid communication with the vacuum source, wherein the breast engagement portion (breast shields 107, 108) is configured to engage a breast of a user to express breast milk (¶ [0020]); and a controller in electrical communication with the vacuum source (¶ [0057]); wherein the controller is configured to determine when the vacuum source is in an activated configuration and calculate a parameter of the pump based on time-wise data collection that the pump is not operating as designed (e.g., has a leak; as per ¶ [0058], this data utilizes variation of measured vacuum levels to determine if a leak is present in the system; ¶ [0050] discloses that historical data for users regarding average pressure values is stored and measured against expected values to determine if an adjustment should be made for a specific user if they consistently have lower pressure readings than expected; in this manner, the device stores historical data and is programmed to compare this historical data to expected values to determine the condition of the system); and wherein the controller is configured to notify a user that one or more components of the breast engagement portion require maintenance or replacement (¶ [0059]). Simmons fails to explicitly disclose the variation being a function of pumping session time.
Ross et al. (henceforth Ross) teaches an infusion pump control system which utilizes a pump session time and compares it to a theoretical value for volume delivered for a pump run time to determine whether or not the pump is operating as desired (Col. 7, lines 9-36 disclose comparing the actual volume of fluid delivered to the anticipated volume which indicates whether the pump is delivering the desired volume of fluid).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Simmons to include the pump volume measurement comparison of Ross so as to provide a means of determining whether or not the pump is working as desired by calculating the fluid flow during a session time as taught by Ross. Since Simmons already contemplates measuring expressed milk volume to determine leakage, it would be obvious to also include a total volume comparison to historical values (e.g., ¶¶ [0094] and [0096] of Simmons).
Regarding claim 2, Simmons further disclose wherein the controller notifies the user via a user interface of the breast pump (e.g., ¶ [0027] discloses displaying feedback through a user interface).
Regarding claim 3, Simmons further discloses wherein the controller notifies the user via at least one of a light source of the breast pump, an audible alert, and an external device (¶ [0027] discloses a visual, tactile, or audio feedback).
Regarding claim 5, Simmons further discloses wherein the historical average pumping session time is calculated by calculating the average of pumping session times for predetermined pumping sessions (Simmons discloses the saving of average values such as average pump time and average suction levels (¶ [0050]; this use of averaged data would be applicable to the session time data saved by Ross and incorporated into the modified device).
Regarding claim 6, Simmons/Ross teach the use of the device for determining a statistically significant variation of the historical average pumping session versus the current pumping session to determine pump functionality, but fail to explicitly disclose the percentage difference of the variation. However, it appears one of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in modifying the device of Simmons/Ross to use a 2% to 50% difference in pump session time as it involves only adjusting a dimension of a component disclosed to require adjustment (e.g., Simmons/Ross teaches that it is known to calculate the difference between observed and expected pump session time variables during use which would inherently vary by some percent difference). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Simmons/Ross to comprise using a difference of between 2% and 50% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 7, Simmons/Ross further teach wherein the recent average pumping session time is calculated by calculating an average time of a least three of the most recent pumping sessions (Simmons teaches in ¶ [0050] the use of saved average values of pump operation which would be applied to the run time data point of Ross; this combination teaches the saving of all pump run time data which would constitute at least three pump sessions, assuming the pump has been used at least three times).
Regarding claim 8, Simmons further discloses wherein the breast engagement portion (breast shields 107, 108) comprises a protection member (conical breast receiving portion of shield as depicted in Figure 5); a flange in fluid communication with the protection member (chamber 505; Figure 6; the extension may be considered a flange as claimed); a container (515) in fluid communication with the flange (Figure 6); and a one-way valve (518) positioned between the flange and the container (Figure 6; ¶ [0109]; valve 518 is a check valve; see also ¶ [0123]).
Regarding claim 9, Simmons further discloses wherein the controller is configured to notify the user that at least one of the protection member and the one-way valve require maintenance or replacement (the controller of Simmons is configured to detect a leak based upon pressure variations within the system; a leak through the check valve, e.g., not seated or sealing correctly, would affect the pressure of the entire system and would be detected by the controller of Simmons; see e.g., ¶¶ [0157]-[0161]).
Claim(s) 4, 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simmons in view of Ross, and further in view of Zhang et al. (US 2019/0099552).
Regarding claims 4 and 12, Simmons/Ross teach the claimed invention substantially as set forth above for claim 1, but fail to explicitly disclose the determination of the cumulative operating time being greater than a predetermined value and notifying the user for maintenance or replacement.
Zhang teaches a medical pump which is programmed from the factory to be initialized with a zero volume set point and which saves the cumulative time the pump has been in operation against a pre-set time limit to prevent use, and alert a user, after the service life of the pump has been exceeded (¶¶ [0060]-[0061]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pump system of Simmons/Ross to include the end-of-life pump data so as to alert a user that the pump has reached its service life ceiling threshold and should be checked as taught by Zhang.
Regarding claim 13, Simmons further discloses wherein the controller notifies the user via at least one of a light source of the breast pump, an audible alert, and an external device (¶ [0027] discloses a visual, tactile, or audio feedback).
Regarding claim 14, Simmons further discloses wherein the breast engagement portion (breast shields 107, 108) comprises a protection member (conical breast receiving portion of shield as depicted in Figure 5); a flange in fluid communication with the protection member (chamber 505; Figure 6; the extension may be considered a flange as claimed); a container (515) in fluid communication with the flange (Figure 6); and a one-way valve (518) positioned between the flange and the container (Figure 6; ¶ [0109]; valve 518 is a check valve; see also ¶ [0123]).
Regarding claim 15, Simmons further discloses wherein the controller is configured to notify the user that at least one of the protection member and the one-way valve require maintenance or replacement (the controller of Simmons is configured to detect a leak based upon pressure variations within the system; a leak through the check valve, e.g., not seated or sealing correctly, would affect the pressure of the entire system and would be detected by the controller of Simmons; see e.g., ¶¶ [0157]-[0161]).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simmons in view of Ross, and further in view of Visconti et al. (US 11,235,093).
Regarding claim 10, Simmons/Ross teach the claimed invention substantially as set forth above for claim 8, but fail to explicitly disclose the use of a diaphragm in the protection member.
Visconti et al. (henceforth Visconti) teaches (Figures 1A-1B) a breastmilk collection device comprising a protection member (110) which houses a diaphragm assembly (106; Col. 7, lines 38-62 disclose the diaphragm).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the breast pump assembly of Simmons/Ross to include the protection member of Visconti so as to allow the components of the negative pressure generating system to be housed in the breast shield assembly as taught by Visconti. Such diaphragm pumps are known in the art for providing a means of extracting milk from the breast during a pumping procedure as taught by Visconti.
Regarding claim 11, Simmons/Ross teach the use of a check valve (518 of Simmons; Figure 6), but fail explicitly disclose it as a duckbill valve.
Visconti further teaches the use of a duckbill valve in the protection member (103; Col. 7, lines 10-15; Figures 1A-1B).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simmons in view of Ross, and further in view of Zhang.
Regarding claim 16, Simmons discloses a controller for a breast pump, the controller configured to perform the steps of using pump data to track a variation of average historical values of pump or system operation from current values to determine if the current values exceed some threshold, and if so, activating a notification element to inform a user that one or more components of the breast pump require maintenance or replacement when the controller determines that at least one of the values exceed the statistically significant variation of the historical versus current data (¶¶ [0056]-[0059] disclose the use of the controller to measure pump/system operation over time and compare these values over a desired time period with the step of comparing the value to threshold values to determine one or more errors of pump operation before alerting a user; see also ¶ [0050] which discloses using averages of measured data for comparison of various pump functions). Simmons fails to explicitly disclose the values as cumulative operating time or average pumping session time.
Ross teaches an infusion pump control system which utilizes a pump session time and compares it to a theoretical value for volume delivered for a pump run time to determine whether or not the pump is operating as desired (Col. 7, lines 9-36 disclose comparing the actual volume of fluid delivered to the anticipated volume which indicates whether the pump is delivering the desired volume of fluid).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Simmons to include the pump volume measurement comparison of Ross so as to provide a means of determining whether or not the pump is working as desired by calculating the fluid flow during a session time as taught by Ross. Since Simmons already contemplates measuring expressed milk volume to determine leakage, it would be obvious to also include a total volume comparison to historical values (e.g., ¶¶ [0094] and [0096] of Simmons).
Simmons/Ross further fail to explicitly disclose the use of cumulative operating time for the pump assembly as a tracked metric.
Zhang teaches a medical pump which is programmed from the factory to be initialized with a zero volume set point and which saves the cumulative time the pump has been in operation against a pre-set time limit to prevent use, and alert a user, after the service life of the pump has been exceeded (¶¶ [0060]-[0061]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pump system of Simmons/Ross to include the end-of-life pump data so as to alert a user that the pump has reached its service life ceiling threshold and should be checked as taught by Zhang.
Regarding claim 13, Simmons further discloses wherein the controller notifies the user via at least one of a light source of the breast pump, an audible alert, and an external device (¶ [0027] discloses a visual, tactile, or audio feedback).
Regarding claim 17, Simmons/Ross further teach the controller is configured to calculate the historical average pumping session time by calculating an average of pumping session times for predetermined pumping sessions (see ¶ [0050] of Simmons which discloses the use of averaged historical pump data which would be applied to the tracking of pumping session times of Ross to determine if the same volume has been collected over the target time period as expected).
Regarding claim 18, Simmons/Ross teach the use of the device for determining a statistically significant variation of the historical average pumping session versus the current pumping session to determine pump functionality, but fail to explicitly disclose the percentage difference of the variation. However, it appears one of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in modifying the device of Simmons/Ross to use a 2% to 50% difference in pump session time as it involves only adjusting a dimension of a component disclosed to require adjustment (e.g., Simmons/Ross teaches that it is known to calculate the difference between observed and expected pump session time variables during use which would inherently vary by some percent difference). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Simmons/Ross to comprise using a difference of between 2% and 50% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 19, Simmons/Ross further teach wherein the recent average pumping session time is calculated by calculating an average time of a least three of the most recent pumping sessions (Simmons teaches in ¶ [0050] the use of saved average values of pump operation which would be applied to the run time data point of Ross; this combination teaches the saving of all pump run time data which would constitute at least three pump sessions, assuming the pump has been used at least three times).
Regarding claim 20, Simmons further discloses wherein the controller notifies the user via at least one of a light source of the breast pump, an audible alert, and an external device (¶ [0027] discloses a visual, tactile, or audio feedback).
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783