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 .
Response to Amendment
The Amendments filed 07/08/2026 have been entered.
Claims 1, 18 and 20 have thereby been amended.
Claims 1-6 and 8-20 are being examined in this office action.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-17, and 20 are rejected under 35 U.S.C. 103 as obvious over Pfenniger (US 20160224611) in view Prentice (US 20150265753) in further view of Haas (EP 2916249) and in further view of Makower (US 20170072118).
Regarding claim 1, Pfenniger discloses a system for improving a breast pumping session comprising: a database (1, 2) having at least one data group (10, 20), wherein the database is configured to send and receive group data (arrows 40, 41, 50, 51) regarding a pumping pattern (page 3, para. [0032]); a data processing unit (3) configured to analyze pumping data regarding the breast pumping session (page. 3, para. [0042]) for the optimization of parameters for a user’s breast pumping sessions. Although Pfenniger discloses this system used in communication with a breast pump and delivering recommendations to the user (page 3, paras. [0032]-[0033]), Pfenniger fails to explicitly disclose the user implementing additional real-time changes during the breast pumping session, a computing device with a user interface and the automated real-time changes to the pumping based on user feedback.
Prentice teaches an analogous breast pump system the breast pump system is configured to implement real-time changes to the breast pumping session based on the user feedback received (para. [0027], sentence 2, the system implements real time changes to the suction of the pump based off the user input), wherein the user implements additional real-time changes during the breast pumping session (para. [0027], sentence 4, the system implements real time changes to the speed of the pump cycles based off the user input). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pfenniger method and device by incorporating the real-time user changes to the pumping as taught by Prentice, in order to be able to make real-time adjustments to optimize the user’s comfort, without having to wait for those changes to be implemented in the next pumping session. However, the Pfenniger-Prentice system fails to teach the computing device with a user interface and the automated real-time changes to the pumping based on user feedback, or that the changes are made and updated via an application.
Haas teaches an analogous system for the optimization of breast pumping that includes the data processing unit (3, according to the system of Haas) being communicably coupled to a computing device (21: page 8 of translation, line 11 reciting a smartphone), the computing device having a user interface (screen on smartphone 21 for app interaction: page 5 of translation, lines 6-7); a breast pump system (80, 82, 83) communicably coupled to the data processing unit (Fig. 1, dashed lines demonstrating data communication between 80 and 3); wherein the computing device is configured to request and receive feedback from a user of the breast pump system during the breast pumping session via the user interface (page 9 of translation, para. 9 regarding Fig. 11b; and page 10 of translation, para. 2 regarding Fig. 13). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pfenniger system by incorporating the breast pump and computing devices of the system taught by Haas (combination illustrated in annotated Fig. 1 below), in order to provide a user interface between the transmission of data between the pump system and the data platform system so the user may see and track the session data and elect to implement changes for optimization (page 9 of translation, second-to-last paragraph, last sentence). However, although Pfenniger teaches the integration of an application for the data processing and optimization (para. [0026], sentence 1), the Pfenniger-Prentice-Haas system fails still to explicitly teach that the real-time changes made by the user is done via an application.
Makower teaches an analogous system for the optimization of breast pumping for a user, and explicitly teaches that the breast pump system is configured to implement real-time changes to the breast pumping session based on the user feedback received via an application (paras. [0197]-[0198]) wherein, during the breast pumping session, the application is configured to prompt the user for feedback concerning the breast pumping session (paras. [0200]-[0201]), receive the feedback via the user interface (Fig. 31; the computer interface: para. [0015]), and communicate the feedback to the data processing unit wherein the data processing unit is configured to determine, based on the feedback received during the breast pumping session (para. [0204]; Fig. 31) and based on the group data regarding the pumping pattern (para. [0205], also uses national averages from data to make projections and modifications), a modification to a pump setting or pumping pattern for the breast pumping session (paras. [0200]-[0201], the application prompts user input based on deficits in milk extractions detected, based on user data that is input, if baby is not weaning and the system determines that milk extraction should be increased, the system can automatically adjust the pumping parameters in real-time: para. [0206]; para. [0199], last two sentences), and wherein the breast pump system is configured to implement the determined modification during the same breast pumping session (para. [0206], the pumps can automatically be set to continue to pump, for example, which occurs real-time during the same pump cycle). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pfenniger-Prentice-Haas system by incorporating this real-time change implementation via the application taught by Makower based on user input, in order to better optimize pumping for milk extraction success while in-use and integrate those changes with the application software of the Pfenniger system without having to wait for future sessions for pumping optimization.
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Annotated Fig. 1:
Combination of the Pfenniger database/data analysis system with the Haas devices and interface
Regarding claim 2, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the breast pumping system comprises a sensing device configured to receive pumping data from the user and to communicate with the data processing unit (Pfenniger: page 3, para. [0042], sentence 1).
Regarding claim 3, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 2, as descried above, wherein the application (Makower: para. [00131]) is associated with the system (Pfenniger: para. [0026], sentence 1), and wherein the application continuously or intermittently determines whether an action should be taken by the user and wherein the action comprises modifying settings of the breast pump system (Haas: page 9 of translation, second-to-last paragraph).
Regarding claim 4, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the data processing unit is configured to cause the database to update the group data based on the analysis of the pumping data (Pfenniger: page 2, para. [0014], sentences 4-6).
Regarding claim 5, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the data processing unit is configured to provide automatic updates to the breast pump system before or during the pumping session (Makower: para. [0196]).
Regarding claim 6, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the group data is continuously updated by the data processing unit based on the user feedback (Pfenniger: page 2, para. [0014], sentences 4-6).
Regarding claim 8, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the application is stored on the computing device (Haas: app on 21, page 5 of translation, lines 6-7), wherein the application continuously or intermittently determines whether an action should be taken by the user and wherein the action comprises modifying settings of the breast pump system (Haas: page 9 of translation, second-to-last paragraph).
Regarding claim 9, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the data processing unit sends a signal to the breast pump system to stop the breast pump system (Makower: pages 15-16, para. [0084], sentences 1-3; stopping explicitly integrated into forementioned real-time updates, page 40, para. [00131], last sentence), wherein the signal is sent through an application (see Annotated Fig. 1 above, wherein application on 21 is intermediate to the data processing unit and the breast pump system).
Regarding claim 10, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the data processing unit generates predictive capabilities based on analysis of the pumping data (Makower: para. [0205]).
Regarding claim 11, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the data processing unit analyzes historical data of the user to predict results of the breast pumping session (Pfenniger: page 2, para. [0015], sentence 5). Although Pfenniger does not explicitly disclose this existing data as historical data of the user, Makower does (Fig. 30; paras. [0199]-[0200]), and it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the historical data as defined by Makower into the predictive data system of Pfenniger, upon the Pfenniger-Haas-Makower combination, to achieve the user-specific, real-time pumping optimization.
Regarding claim 12, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the data processing unit provides recommended settings for the breast pump system to the user based on the analysis of the pumping data (Haas: page 9 of translation, second-to-last paragraph).
Regarding claim 13, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 1, as descried above, wherein the breast pump system comprises a breastshield (Haas: breast cap, 81) having a portion within which a woman's breast is received for the expression of milk (Haas page 9 of translation: second paragraph regarding Fig. 7, sentence 2).
Regarding claim 14, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 13, as descried above, wherein the breast pump system further comprises a sensing device configured to receive pumping data from the user and transmit the pumping data to the data processing unit and wherein the sensing device is located on or in communication with the breastshield (Haas page 9 of translation: second paragraph regarding Fig. 7, sentences 4-5).
Regarding claim 15, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 14, as descried above, wherein the breast pump system further comprises a controller configured to execute the pumping pattern for the breast pumping session (Makower: 52; paras. [0203] and [0206]), wherein the controller is further configured to send pumping data to a data processing unit for analysis (Makower: Fig. 31: software 474 processing unit; para. [0203], sentences 1-2).
Regarding claim 16, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 15, as descried above, wherein the breast pump system comprises a breast pump housing within which the source of pressure (Makower: Fig. 13E: compression member 38 within 34) and the controller are positioned (Makower: controller 52 within 34). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated into the Pfenniger-Haas-Makower system, the teachings of the controller and pressure source being positioned in the housing of the breast pump system, as taught by Makower, in order to achieve the real-time pumping optimization.
Regarding claim 17, Pfenniger in view of Prentice in further view of Haas in further view of Makower teaches the system of claim 16, as descried above, wherein the breast pump system further comprises a collection container (Haas: 82, Fig. 6) releasably secured to the breastshield (Haas: 81, Fig. 6).
Regarding claim 20, Pfenniger discloses a system for improving a breast pumping session comprising: a database (1, 2) having a plurality of data groups (10, 20), wherein each data group of the plurality of data groups has a corresponding pumping pattern (page 3, para. [0044], sentences 1-3); a data processing unit (3), the data processing unit being configured to analyze pumping data regarding the breast pumping session (page. 3, para. [0042], sentence 1), identify a data group corresponding the pumping data and transmit the pumping pattern corresponding to the identified data group during the breast pumping session (page 4, Example 4 implementation: paras. [0055] and [0057]); a breast pump system communicably coupled to the data processing unit (page. 3, para. [0042], sentences 1-2). However, Pfenniger fails to explicitly disclose the user implementing additional real-time changes during the breast pumping session, and a computing device with a user interface and the real-time changes to the pumping based on user feedback.
Prentice teaches an analogous breast pump system wherein the user implements additional real-time changes during the breast pumping session (para. [0027], particularly sentence 1, screen 400 on input device 500). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pfenniger method and device by incorporating the real-time user changes to the pumping as taught by Prentice, in order to be able to make real-time adjustments to optimize the user’s comfort, without having to wait for those changes to be implemented in the next pumping session. However, the Pfenniger-Prentice system fails to teach the computing device with a user interface and the automated real-time changes to the pumping based on user feedback.
Haas teaches an analogous system for the optimization of breast pumping that includes the data processing unit (3, according to the system of Haas) being communicably coupled a computing device (21: page 8 of translation, line 11 reciting a smartphone), the computing device having a user interface (screen on smartphone 21 for app interaction: page 5 of translation, lines 6-7), wherein the computing device is configured to request and receive feedback from a user of the breast pump system during the breast pumping session via the user interface (page 9 of translation, para. 9 regarding Fig. 11b; and page 10 of translation, para. 2 regarding Fig. 13). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pfenniger system by incorporating the computing devices of the system taught by Haas, in order to provide a user interface between the transmission of data between the pump system and the data platform system so the user may see and track the session data and elect to implement changes for optimization (page 9 of translation, second-to-last paragraph, last sentence). However, Haas teaches that the pumping sessions are optimized through the optimization of pumping parameters that are later updated/implemented to the pump device (page 9 of translation, second-to-last paragraph). However, although Pfenniger teaches the integration of an application for the data processing and optimization (para. [0026], sentence 1), the Pfenniger-Prentice-Haas system fails still to explicitly teach that the real-time changes made by the user is done via an application.
Makower teaches an analogous system for the optimization of breast pumping for a user, and explicitly teaches that wherein the computing device is configured to receive feedback pumping pattern from a user of the breast pump system during the breast pumping session via the user interface (Fig. 31; the computer interface: para. [0015]); wherein the breast pump system is configured to implement the pumping pattern during the breast pump session based on the user feedback received by the user interface (Fig. 31; paras. [0205]-[0206], user-entered inputs into the app determine the new control parameters), wherein the user implements additional real-time changes during the breast pumping session via an application (para. [0203]), wherein, during the breast pumping session, the application is configured to prompt the user for feedback concerning the breast pumping session (paras. [0200]-[0201]), receive the feedback via the user interface, and communicate the feedback to the data processing unit, wherein the data processing unit is configured to determine a modified pumping pattern based on the pumping pattern corresponding to the identified data group and the feedback received from the user during the breast pumping session (para. [0204]; Fig. 31; para. [0205], also uses national averages from data to make projections and modifications), and wherein the data processing unit is configured to transmit the modified pumping pattern to the breast pump system (paras. [0200]-[0201], the application prompts user input based on deficits in milk extractions detected, based on user data that is input, if baby is not weaning and the system determines that milk extraction should be increased, the system can automatically adjust the pumping parameters in real-time: para. [0206]; para. [0199], last two sentences) for implementation during the same breast pumping session (para. [0206], the pumps can automatically be set to continue to pump, for example, which occurs real-time during the same pump cycle). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pfenniger-Prentice-Haas system by incorporating this real-time change implementation via the application taught by Makower based on user input, in order to better optimize pumping for milk extraction success while in-use and integrate those changes with the application software of the Pfenniger system without having to wait for future sessions for pumping optimization.
Claims 18-29 are rejected under 35 U.S.C. 103 as obvious over Pfenniger (US 20160224611) in view Prentice (US 20150265753) in view of Makower (US 20170072118).
Regarding claim 18, Pfenniger discloses a method for improving a breast pumping session of a breast pump system, the method comprising: receiving, via a data processing unit (3), pumping data of a user regarding a breast pumping session from the breast pump system (page. 3, para. [0042], sentences 1-2); analyzing, via the data processing unit, the pumping data and comparing the pumping data to group data (page 2, para. [0025], sentence 1); sending, via the data processing unit, a message to the breast pump system based on the analysis of the pumping data and thereby causing implementation of a modification to a mode of operation of the breast pump system during the breast pumping session based on the analysis of the pumping data (page 3, para. [0032] and para. [0033], lines 1-4). However, Pfenniger does not explicitly disclose the user implementing additional real-time changes during the breast pumping session.
Prentice teaches an analogous breast pump system wherein the user implements additional real-time changes during the breast pumping session (para. [0027], particularly sentence 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pfenniger method and device by incorporating the real-time user changes to the pumping as taught by Prentice, in order to be able to make real-time adjustments to optimize the user’s comfort, without having to wait for those changes to be implemented in the next pumping session. However, although Pfenniger teaches the integration of an application for the data processing and optimization (para. [0026], sentence 1), the Pfenniger-Prentice system fails still to explicitly teach that the real-time changes made by the user is done via an application.
Makower teaches an analogous system for the optimization of breast pumping for a user, and explicitly teaches that during the breast pumping session, prompting, via an application, the user for feedback concerning the breast pumping session (paras. [0200]-[0201]); receiving, via the application, the feedback during the breast pumping session (Fig. 31: user-entered inputs received by the app determine the new control parameters); communicating, via the application, the feedback to the data processing unit (Fig. 31: user-entered inputs received by the app determine the new control parameters, para. [0204]); analyzing, via the data processing unit, the pumping data and the feedback received during the breast pumping session in view of the group data (para. [0204] and para. [0205], also uses national averages from data to make projections and modifications); determining, via the data processing unit and based on the analysis of the pumping data and the feedback in view of the group data, a modification to a pump setting or pumping pattern for the breast pumping session (para. [0204]; Fig. 31; paras. [0200]-[0201], the application prompts user input based on deficits in milk extractions detected, based on user data that is input, if baby is not weaning and the system determines that milk extraction should be increased, the system can automatically adjust the pumping parameters in real-time: para. [0206]; para. [0199], last two sentences); and sending, via the data processing unit during the same breast pumping session, a message to the breast pump system, thereby causing the breast pump system to implement the determined modification during the same breast pumping session (Figs. 31 and 33; para. [0210]; para. [0206], the pumps can automatically be set to continue to pump, for example, which occurs real-time during the same pump cycle). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pfenniger-Prentice-Haas system by incorporating this real-time change implementation via the application taught by Makower in order to better optimize pumping for milk extraction success while in-use and integrate those changes with the application software of the Pfenniger system.
Regarding claim 19, Pfenniger in view of Prentice in further view of Makower teaches the method of claim 18, as described above, wherein analyzing the pumping data and comparing the pumping data to group data comprises updating the group data based on the analysis of the pumping data (Pfenniger: page 4, Example 4: para. [0058]).
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but are considered moot in light of the new claim amendments and new grounds of rejections. The rejections of independent claims 1, 18 and 20 newly rely on Makower (US 20170072118) to teach the new claim limitations. Unlike Pfenniger, Prentice, Haas, or the first Makower (WO 2017139437) reference, the new Makower (US 20170072118) reference does specifically teach the system’s prompting the user for input, and specifically teaches the user input and pumping pattern adjustments being able to be made all within a single pumping session.
For these reasons, claims 1-6 and 8-20 stand rejected in further view of Makower (US 20170072118), as recited above.
Conclusion
THIS ACTION IS MADE FINAL. 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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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
