DETAILED ACTION
Response to Amendment
The amendment filed July 16, 2026 has been entered. Claims 1 and 7 have been amended, claims 5 and 12-20 have been cancelled, and claims 21-27 have been newly added. Claims 1-4, 6-11, and 21-27 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the new and amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
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, 6-9, 21-25, and 27 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), and further in view of Pfeiffer et al. (US 2020/0225648).
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 corresponding to a pumping session (e.g., ¶ [0024]) 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 calculate an average pumping session time of an accumulated number of pumping sessions (see e.g., ¶ [0050] which discloses saving average pump time as a stored variable); 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 further discloses the tracking of pump session duration (¶ [0039]) but fails to explicitly disclose the variation comparison being a function of pumping session time and the use of fewer than the accumulated number of sessions for the comparison.
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).
Simmons/Ross also fail to teach using a number of sessions less than the accumulated number.
However, Pfeiffer et al. (henceforth Pfeiffer) teaches a method of saving and processing fluid pump data by transferring a subset of the measurement data to be processed (¶ [0043]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the analysis methods of Simmons/Ross to include the step of using only a subset of the accumulated historical pump data since Pfeiffer teaches that such an analysis method is known to be used in fluid pump data analysis. In addition, reducing the amount of data to be analyzed results in faster calculations and less memory consumption by the pump controller which increases the efficiency of the system.
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 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/Pfeiffer fail to explicitly teach wherein the most recent number of pumping sessions is at least three. Simmons teaches (¶ [0050]) that the average pump time is saved as historical data, and Pfeiffer teaches using some subset of all historical data to perform the threshold comparison, but they fail to explicitly disclose using at least three sessions from said historical data. Furthermore, 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 controller of Simmons/Ross/Pfeiffer to use at least three sessions as it involves only adjusting a dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Simmons/Ross/Pfeiffer to comprise using at least three pumping sessions from the saved historical data 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 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]).
Regarding claims 21 and 27, Simmons further discloses wherein the accumulated number of pumping sessions corresponds to a number of pumping sessions from a zero setting of a timer in communication with the controller (¶ [0038], the pump is designed to collect data about pump usage across all pumping events; this storage anticipates a zero start before the pump is used for the first time to generate the first series of operational data for saving and tracking).
Regarding claim 22, Simmons discloses a controller for a breast pump (110), the controller configured to perform the steps of determining when the vacuum source (the breast pump is a negative pressure pump; ¶ [0088]) is in an activated configuration corresponding to a pumping session (¶¶ [0050] and [0058]; the system uses measured vacuum levels and average pressure values stored and compared to expected data for determining pump health); calculating an average pumping session time of an accumulated number of pumping sessions (¶ [0050], the system tracks average pump time for pumping sessions for a user), based on the determination that the vacuum source is in the activated configuration (the system tracking for pump features is done during a procedure which applies vacuum when the procedure is initialized as it’s a suction pump); and generating a user notification indicating that one or more components of a breast engagement portion of the breast pump require maintenance or replacement when a measured value is greater than a statistically significant variation of the historical data (Simmons applies this comparison to vacuum via comparing pressure values over the pumping session to expected values in ¶ [0059]; any threshold variation is inherently statistically significant since it’s outside of the defined boundaries of what is set as the threshold value). Simmons fails to explicitly disclose the variation comparison being a function of pumping session time and the use of fewer than the accumulated number of sessions for the comparison.
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).
Simmons/Ross also fail to teach using a number of sessions less than the accumulated number.
However, Pfeiffer et al. (henceforth Pfeiffer) teaches a method of saving and processing fluid pump data by transferring a subset of the measurement data to be processed (¶ [0043]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the analysis methods of Simmons/Ross to include the step of using only a subset of the accumulated historical pump data since Pfeiffer teaches that such an analysis method is known to be used in fluid pump data analysis. In addition, reducing the amount of data to be analyzed results in faster calculations and less memory consumption by the pump controller which increases the efficiency of the system.
Regarding claim 23, 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 24, Simmons/Ross/Pfeiffer fail to explicitly teach wherein the most recent number of pumping sessions is at least three. Simmons teaches (¶ [0050]) that the average pump time is saved as historical data, and Pfeiffer teaches using some subset of all historical data to perform the threshold comparison, but they fail to explicitly disclose using at least three sessions from said historical data. Furthermore, 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 controller of Simmons/Ross/Pfeiffer to use at least three sessions as it involves only adjusting a dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Simmons/Ross/Pfeiffer to comprise using at least three pumping sessions from the saved historical data 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 25, 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).
Claim(s) 4 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simmons in view of Ross in view of Pfeiffer, and further in view of Zhang et al. (US 2019/0099552).
Regarding claim 4 and 26, Simmons/Ross/Pfeiffer 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/Pfeiffer 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 in view of Pfeiffer, 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/Pfeiffer 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, Visconti further teaches the use of a duckbill valve in the protection member (103; Col. 7, lines 10-15; Figures 1A-1B).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
