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 .
Status of Claims
This Final Office Action is in response to the Amendment and Remarks filed 09/16/2025. Claims 1-14 have been amended and claims 1-15 are currently pending and considered herein.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 3, 8 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/0136160 A1 to Barral et al., hereinafter “Barral” in view of U.S. 8,280,493 B2 to Kolberg et al., hereinafter “Kolberg.”
Regarding claim 1, Barral discloses A system for determining a breast feeding or breast pumping session, comprising: an input for receiving: first milk flow information from a breast pump from breast pumping sessions, comprising at least the time and milk volume received by the breast pump of each breast pumping session (See Barral at least at Abstract; Paras. [0017]-[0030] (“[A] breast pump, a lactation sensor, an interface circuit that communicates with a consumption sensor associated with a bottle, and a control circuit. During operation, the breast pump collects milk from an individual during one or more breast-pumping sessions. Moreover, the lactation sensor measures a volume of the collected milk as a function of time. Furthermore, the interface circuit receives information specifying milk consumption by a second individual (such as a baby) as a function of time. […] the interface circuit receives information specifying milk consumption by a second individual (such as a baby) as a function of time […] the interface circuit may receive additional information specifying: a vital sign of the second individual as a function of time, a biomarker of the second individual as a function of time, and/or an activity pattern of the second individual as a function of time. Then, the control circuit may determine the need for milk based on: a temporal pattern of the vital sign of the second individual, a temporal pattern of the biomarker of the second individual, and/or a temporal pattern of the activity pattern of the second individual.”); Claims 4, 5, 7; Figs. 1, 10, 11); and a processor for processing the first and second milk flow information to determine future breast pumping and breast feeding sessions (See id. at least at Paras. [0021]-[0032] (“the breast pump collects milk from an individual during one or more breast-pumping sessions […] the interface circuit receives information specifying milk consumption by a second individual (such as a baby) as a function of time” i.e., breast pumping sessions and breast feeding sessions milk flow information), [0047], [0058]-[0059], [0067], [0074]-[0080] (“In addition to initiating a breast-feeding session when a need for milk is determined, control circuit 188 may initiate a breast-pumping session: after a predefined time interval since a previous breast-feeding session (such as one hour, two hours, three hours, etc.), according to a predefined schedule.”), [0088]-[0099] (“[U]ser interface 800 may include a woman's time-varying lactation cycle or pattern and a baby or infant's time-varying consumption cycle or pattern […] The system may allow pumping automation to synchronization with the baby's feed times/durations (including knowing when the baby is feeding at a remote location) and is able to alert the mother (at a minimum) to pump or actually initiate pumping in synchronization with the baby's feedings […] the system determines a need for milk (operation 1014) based on a temporal pattern of the volume of the collected milk and a temporal pattern of the milk consumption. Next, the system provides feedback (operation 1016) based on the determined need for milk that synchronizes the one or more breast-pumping sessions and the milk consumption.”), [0101]; Claims 8, 9; Figs. 1, 10, 11).
Barral may not specifically describe but Kolberg teaches second milk flow information from breast feeding sessions, comprising at least the time and milk volume expressed for each breast feeding session (See Kolberg at least at Abstract (“an apparatus for measuring the quantity of milk consumed by an infant during a breast-feeding session.”); Col. 2, ln. 38-67; Claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral to incorporate the teachings of Kolberg and provide milk volume expressed during a breast feeding session. Kolberg is directed to a breast milk flow meter and apparatus. Incorporating the breast milk flow apparatus as in Kolberg with the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Regarding claim 3, Barral as modified by Kolberg discloses all the limitations of claim 1 and Barral further discloses wherein the processor uses machine learning to derive the future sessions (See id. at least at Paras. [0074]-[0080], [0088]-[00101] (“These measurements may be used in supervised or machine learning of the pumping technique. The system may learn and remember lessons from prior breast-pumping session and may cumulatively apply them to future sessions, so that the learning is ‘across’ and ‘between’ sessions, not just ‘within’ a session.”).
Regarding claim 8, Barral as modified by Kolberg discloses all the limitations of claim 1 and Barral further discloses wherein the processor is adapted to inform the user about an upcoming milk expression or feeding session by means of a notification. (See id. at least at Abstract; Paras. [0021]-[0023] (“Note that the feedback may alert the individual to initiate a breast-pumping session. Alternatively or additionally, the feedback may include a signal to the breast pump that initiates a breast-pumping session.”), [0067]-[0067], [0078]-[0079], [0088]).
Regarding claim 14, claim 14 recites substantially the same limitations included in independent claim 1. Thus, claim 14 is rejected under the same grounds of rejection and for the same reasoning as applied to claim 1, above.
Regarding claim 15, Barral as modified by Kolberg discloses all the limitations of claim 14 and Barral further discloses A computer program comprising computer program code means which is adapted, when said program is run on a computer, to implement the method of claim 14 (See id. at least at Paras. [0026]-[0032], [0047], [0058]-[0059], [0067], [0074]-[0080], [0088]-[0099], [0101]; Claims 8, 9; Figs. 1, 10, 11).
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Barral, in view of Kolberg and further in view of U.S. 2019/0198175 A1 to Sallade et al., hereinafter “Sallade.”
Regarding claim 2, Barral and Kolberg discloses the limitations of claim 1. The references may not specifically describe but Sallade teaches wherein the input is further for receiving a desired milk production objective, comprising one of stockpiling, maximizing baby growth, achieving a consistent rhythm, reducing night time expression or feeding, or achieving breast emptying, and the processor is further for processing the objective to derive the future sessions (See Sallade at least at Abstract; Paras. [0002]-[0003], [0006]-[0010], [0025]-[0031]; Figs. 1, 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Sallade and provide milk production objectives, increasing stores and consistently pumping. Sallade is directed to a method and application for optimizing an infant feeding plan. Incorporating the optimization techniques for infant feeding plans as in Sallade with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Regarding claim 11, Barral discloses all the limitations of claim 1. Barral may not specifically describe but Sallade teaches wherein the input is further for receiving one or more of: user weight tracking information; baby weight tracking information; and milk weight or volume tracking information (See Sallade at least at Abstract; Paras. [0006]-[0009], [0021]-[0022], [0025]-[0026], [0034]; Fig. 5; See also Barral at least at Paras. [0088]-[0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Sallade and provide metrics of the baby and mother and milk. Sallade is directed to a method and application for optimizing an infant feeding plan. Incorporating the optimization techniques for infant feeding plans as in Sallade with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Barral, in view of Kolberg and further in view of U.S. 2015/0112298 A1 to Pirzada et al., hereinafter “Pirzada.”
Regarding claim 4, Barral and Kolberg discloses all the limitations of claim 1. The references may not specifically describe but Pirzada teaches wherein the schedule specifies the duration of the breast pumping and breast feeding sessions, for example separately for each breast (See Pirzada at least at Abstract; Paras. [0003], [0039], [0044]; Claims 11, 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Pirzada and provide a milk production schedule including duration. Pirzada is directed to a breast pump system and program for pumping breasts. Incorporating the breast pump system and program of Pirzada with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Barral, in view of Kolberg and further in view of U.S. 9,623,160 B2 to Alvarez et al., hereinafter “Alvarez.”
Regarding claim 5, Barral and Kolberg discloses the limitations of claim 1. The references may not specifically describe but Alvarez teaches wherein the input is further for receiving a user diary schedule, and the processor is further for processing the user diary schedule to derive the future breast pumping and breast feeding sessions (See Alvarez at least at Col. 1, ln. 22-44 (“[T]o provide a way for users to automatically keep track of the expressed milk inventory, to manage the inventory, and even forecast both future consumption and production.); Col. 11, ln. 18-43 (“In many instances, it can be desirable to measure and track various characteristics of the collected fluid such as milk expression and collection, such as the amount of milk production (e.g., volume, weight), expression frequency (e.g., time, date), expression duration, and/or the composition of the expressed milk. In existing approaches, the tracking of milk production is commonly accomplished by manual measurements and record-keeping. Exemplary embodiments of the devices described herein may provide digital-based means to automatically measure and track milk production for improved convenience, efficiency, and accuracy. In order to facilitate milk inventory tracking and management, a unique identifier may be assigned to the milk expressed during a single pumping session and preferably for only a single breast. Alternatively, a single unique identifier may be assigned to milk expressed during multiple pumping sessions within a pre-designated time window, from one or both breasts. The pre-designated time window may comprise any length of time that is appropriate or convenient for a user in managing the user's milk inventory. For example, many users combine milk expressed during multiple pumping sessions within the same calendar day or within 24 hours. Accordingly, the same unique identifier may be assigned to milk expressed during all pumping sessions within the desired time window.”); Col. 20, ln. 62 – Col. 21, ln. 12 (“In preferred embodiments, the control signals can be generated using feedback provided by the pumping device 800, such as feedback based on measurement data provided by the sensing unit 825, as previously described herein. Additionally, the computing device 805 or server 810 may implement machine learning techniques with regard to control of the pumping device 800, in order to improve and optimize pumping performance over time. Furthermore, the pumping device 800, computing device 805, and/or server 810 can be configured to provide notifications reminding the user to express milk. Such notifications can help avoid missed pumping sessions, and thus reduce the incidence of associated complications such as mastitis. The notifications can be generated based on previously collected milk expression data, such as data relating to expression frequency and/or the timing of previous pumping sessions, as well as based on user preferences.”); Col. 26, ln. 46 – Col. 28, ln. 8; Fig. 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Alvarez and provide milk production schedule based on previously recorded pumping metrics (diary) for a schedule. Alvarez is directed to quantification and inventory management of expressed human breast milk. Incorporating the quantification and inventory management techniques as in Alvarez with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Barral, in view of Kolberg and further in view of U.S. 10,052,418 B2 to Simmons et al., hereinafter “Simmons.”
Regarding claim 6, Barral and Kolberg discloses all the limitations of claim 1. The references may not specifically describe but Simmons teaches wherein the input is further for receiving location information such that the first milk flow information and the second milk flow information each include associated location information, and wherein the processor is further for processing the location information, and a location for each breast pumping and breast feeding session (See Simmons at least at Col. 6, ln. 63 – Col. 7, ln. 12; Col. 12, ln. 10-40; Col. 13, ln. 45-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Simmons and provide milk production schedule and location information. Simmons is directed to a breastmilk expression system. Incorporating the breastmilk expression system as in Simmons with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Barral, in view of Kolberg and further in view of U.S. 2015/0088304 A1 to Ameye et al., hereinafter “Ameye.”
Regarding claim 9, Barral and Kolberg discloses all the limitations of claim 1. The references may not specifically describe but Ameye teaches wherein the input is further for receiving user information comprising at least age and relevant health conditions and baby information comprising at least age, weight and length and the processor is further for processing the user and baby information to determine future sessions (See Ameye at least at Paras. [0071]-[0075] (“By the expressions "health parameters of the infant" it is meant to be parameters related to the infant such as physical, physiological or birth-related data enabling the determination of the nutritional needs of the infant and having an incidence of the composition of the nutritional composition. Some non-limiting examples include weight, length, head circumference, the gestational age (age at birth), the corrected age (weeks or months after birth corrected according to the age at birth), the post gestational age.”), [0085]-[0089], [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Ameye and provide conditions of the baby to consider for breastfeeding. Ameye is directed to providing metered amounts of nutrition to infants. Incorporating the controlled provision of nutrition to infants as in Ameye with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Claims 7, 10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Barral, in view of Kolberg and further in view of U.S. 2019/0088357 A1 to Lee et al., hereinafter “Lee,”
Regarding claim 7, Barral and Kolberg discloses all the limitations of claim 1. The references may not specifically describe but Lee teaches wherein the input is further for receiving validation information indicating the extent to which the future sessions occurred (See Lee at least at Paras. [0004], [0028]-[0029] (“[T]he remote server may thereafter be preferably operative to: a) confirm that the recommended new mother action was applied, b) receive updated information from the sensors indicative of one or more measures of a current breastfeeding quality for the infant, c) receive updated information from the new mother communication device indicative of a current new mother perception of breastfeeding quality for the infant, d) receive an updated new mother perception of the breastfeeding quality for the infant; and e) evaluate the effectiveness of the recommended action in improving the new mother's perception of breastfeeding quality.”), [0037], [0087]; Claims 18, 19; Figs. 6, 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Lee and provide that the mother is adhering to the pumping schedule/procedure. Lee is directed to a lactation coaching system and method. Incorporating the lactation coaching systems of Lee with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Regarding claim 10, Barral discloses the limitations of claim 1 and further discloses stress level indication for the user (See Barral at least at Para. [0096]; and dietary intake information for the user (See id. at least at Para. [0076]); and user sleep tracking information (See id. at Para. [0076] (user sleep tracking and activities). Barral may not specifically describe but Lee teaches wherein the input is further for receiving one or more of: baby sleep tracking information and activity information for the user (See Lee at least at Paras. [0028], [0047], [0052]-[0055] (“Information gathered may include tracking of the infant's daily activities (sleeping, feeding, diapering and so on); information about the date, season, day of the week and weather; and information about environmental conditions proximate to the infant.”), [0089]; Figs. 1, 3, 6; See also Barral at Para. [0076] (user sleep tracking and activities)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Lee and provide infant sleep schedule information and activity. Lee is directed to a lactation coaching system and method. Incorporating the lactation coaching systems of Lee with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Regarding claim 12, Barral discloses the limitations of claim 1. Barral may not specifically describe but Lee teaches wherein the processor is further adapted to suggest behavioral changes to improve milk production (See Lee at least at Paras. [0028] (“recommend at least one action to be taken by the new mother as a function of the new mother typing traits, the breastfeeding quality measures and the new mother perception of the breastfeeding quality for the infant, and... transmit the recommended action to the new mother communication device for execution by the new mother"), [0073], [0082], [0084]-[0090]; Claim 25; Figs. 6A, 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Lee and provide infant sleep schedule information and activity. Lee is directed to a lactation coaching system and method. Incorporating the lactation coaching systems of Lee with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Regarding claim 13, Barral discloses the limitations of claim 1 and further discloses one or more of: a breast pump having a milk flow sensor arrangement (See Barral at least at Para. [0057]-[0059]; Figs. 1, 2); a user interface for allowing entry of user date to the system and output of the schedule (See id. at least at Paras. [0075]-[0089]; Figs. 7-9); and a scale for monitoring a weight of the baby or the mother or the milk produced during expression (See id. at least at Para. [0063]).
Barral may not specifically describe but Lee teaches a GPS location system (See Lee at least at Paras [0072]-[0073]); and a flow sensor arrangement for monitoring milk flow during breast feeding (See id. at least at Paras. [0081]-[0083], [0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Barral and Kolberg to incorporate the teachings of Lee and provide a GPS location system and flow sensor for breast feeding. Lee is directed to a lactation coaching system and method. Incorporating the lactation coaching systems of Lee with the breast milk flow apparatus as in Kolberg and the techniques for synchronizing breast pumping and infant feeding as in Barral would thereby increase the applicability, utility, and efficacy of the claimed systems and method for planning breast feeding or milk expression.
Response to Arguments
Applicant’s Amendment and Remarks filed September 16, 2025 have been fully considered, but they are not entirely persuasive. The following explains why:
Applicant’s arguments pertaining to subject matter eligibility are persuasive. The rejection under 35 U.S.C. §101 has been considered under the 2019 and 2024 Patent Subject Matter Eligibility Guidance (PEG) and recent instruction from Director Squires on 12/4/2025, and has been withdrawn. The arguments at page 5 of Applicant’s Response are persuasive and the rejection is withdrawn.
Applicant’s arguments pertaining to prior art rejections are not persuasive. The argument at pages 5-6 is not persuasive and the Examiner finds the broadly claimed “milk flow information from breast feeding sessions” of claim 1 is read on by and corresponds to a volume expressed and time of session for an infant as in Barral and discussed above. Barral states “the interface circuit receives information specifying milk consumption by a second individual (such as a baby) as a function of time.” This is milk flow information from breast feeding sessions and is not reliant on a bottle or Barral limited to that interpretation as argued by Applicant. Furthermore, Kolberg is now relied on to show a monitored breast feeding session and without any bottle. The arguments at pages 5-8 are moot in light of at least new reference Kolberg, as discussed above. As such, it is submitted that the newly cited combination of prior art, including those identified by Applicant, in the same field of endeavor, i.e., techniques for monitoring of and timing breast pumping and feeding, teaches and/or suggests all of the limitations of the pending claims under a broad and reasonable interpretation thereof.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM T. MONTICELLO whose telephone number is (313)446-4871. The examiner can normally be reached M-Th; 08:30-18:30 EST.
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/WILLIAM T. MONTICELLO/ Examiner, Art Unit 3681
/MARC Q JIMENEZ/ Supervisory Patent Examiner, Art Unit 3681
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