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 Amendment filed on 7/24/2026 has been entered. Claims 1-11 and 13-15 remain pending in the application. Claims 16-21 are new. Claims 13-15 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 3/25/2026.
Applicants amendments to the drawings have failed to overcome the drawing objections previously set forth in the Non-final Office Action mailed 3/25/2026. It is noted that the amendment filed 7/24/2026 discusses changes made to figure 1. However, it does not appear a copy of figure 1 was included. Accordingly, the drawing objections still remain.
Applicant has not addressed the specification objection set forth in the Non-final Office Action mailed 3/25/2026. Accordingly, the specification objection still remains.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 3/25/2026.
Applicants amendments to the claims have failed to overcome all of the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 3/25/2026. Additionally, the amendments to the claims have necessitated new rejections under 35 U.S.C. 112. See rejections under 35 U.S.C. 112 below.
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 2, line 9 states “a simulation mode”. This appears to be a typo. Examiner suggests replacing “a simulation mode” on page 2, line 9 with “a stimulation mode”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 16-21 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is noted that claims 2-5, 7, and 11 depend on claim 19. For clarity purposes the rejection of claim 19 appears after the rejection of claim 1.
In regard to claim 1,
Line 7-8 recites “such that the first kit is configurable by a user to select different functional units for the set of first functional units”. It is unclear what is meant by this. It is unclear based on the disclosure how the first kit is configurable to select different functional units for the set of first functional units. The first kit does not appear to select different functional units, rather the user can select different functional units. For examination purposes Examiner construes “such that the first kit is configurable by a user to select different functional units for the set of first functional units” to be “such that some of the at least some of first functional units that are modular can be selected by a user to provide a number of the first functional capabilities”. Examiner suggests replacing “such that the first kit is configurable by a user to select different functional units for the set of first functional units” in line 7-8 of claim 1 with “such that some of the at least some of first functional units that are modular can be selected by a user to provide a number of the first functional capabilities”.
Line 8 recites “different functional units”. It is unclear if the different functional units are different first functional units or other different functional units. For examination purposes Examiner construes the different functional units to be the same as the first functional units that are modular. Examiner suggests amending line 7-8 of claim 1 as suggested above.
Line 11-12 recites “for implementing at least one of a stimulation mode for triggering a milk ejection reflex an expression mode for milk expression”. It is unclear what is meant by this. It is unclear if “for implementing at least one of a stimulation mode for triggering a milk ejection reflex an expression mode for milk expression” is intended to be “for implementing at least one of a stimulation mode for triggering a milk ejection reflex or an expression mode for milk expression”. For examination purposes Examiner construes “for implementing at least one of a stimulation mode for triggering a milk ejection reflex an expression mode for milk expression” to be “for implementing at least one of a stimulation mode for triggering a milk ejection reflex or an expression mode for milk expression”. Examiner suggests replacing “for implementing at least one of a stimulation mode for triggering a milk ejection reflex an expression mode for milk expression” in line 11-12 of claim 1 with “for implementing at least one of a stimulation mode for triggering a milk ejection reflex or an expression mode for milk expression”.
Examiner notes claims 2-11 and 16-21 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 19,
Line 4-6 recites “such that the second kit is configurable by the user to select different functional units for the set of first functional units”. It is unclear what is meant by this. It is unclear based on the disclosure how the second kit is configurable to select different functional units for the set of first functional units. It appears “for the set of first functional units” in line 5-6 should be “for the set of second functional units”. Additionally, the second kit does not appear to select different functional units for the first kit, rather the user can select different functional units for the second kit. For examination purposes Examiner construes “such that the second kit is configurable by the user to select different functional units for the set of first functional units” to be “such that some of the at least some of second functional units that are modular can be selected by the user to provide a number of the second functional capabilities”. Examiner suggests replacing “such that the second kit is configurable by the user to select different functional units for the set of first functional units” in line 4-6 of claim 1 with “such that some of the at least some of second functional units that are modular can be selected by the user to provide a number of the second functional capabilities”.
Line 5 recites “different functional units”. It is unclear if the different functional units are different second functional units or other different functional units. For examination purposes Examiner construes the different functional units to be the same as the second functional units that are modular. Examiner suggests amending line 5 of claim 19 as suggested above.
Line 7-8 recites “wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system”. Claim 19 depends on claim 1. Claim 1 already states that the set of first functional units of the first kit constitutes a drive system. It is unclear how the set of first functional units of the first kit constitutes a drive system while also the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system. If the set of first functional units of the first kit alone constitutes the drive system as claimed in claim 1, it is unclear how the drive system can now be claimed as formed by the set of second functional units of the second kit, together with the set of first functional units of the first kit. For examination purposes Examiner construes “wherein the set of first functional units of the first kit constitutes a drive system” in claim 1 to be “wherein the set of first functional units of the first kit constitutes a portion of a drive system” AND “wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system” in claim 19 to be “wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes an entirety of the drive system”. Examiner suggests replacing “wherein the set of first functional units of the first kit constitutes a drive system” in claim 1 with “wherein the set of first functional units of the first kit constitutes a portion of a drive system” AND “wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system” in claim 19 with “wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes an entirety of the drive system”.
Line 9-10 recites “the different expression mode”. There is insufficient antecedent basis for the limitation in this claim. Claim 19 depends on claim 1. Claim 1 recites “an expression mode for milk expression”. It is unclear if the different expression mode is intended to be the same as the expression mode for milk expression. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the different expression mode” in line 9-10 of claim 19 with “the expression mode for milk expression”. If ended to be different, Examiner suggests replacing “the at least one of the stimulation mode for triggering the milk ejection reflex or the different expression mode” with “at least one of the stimulation mode for triggering the milk ejection reflex or the expression mode for milk expression or a different expression mode”.
Examiner notes claims 2-5, 7, 11 and 20-21 are similarly rejected by virtue of their dependency on claim 19.
In regard to claim 2,
Line 2-3 recites “the set of the first functional units of the first kit of the drive system implements”. It is unclear if a method step is being claimed due to the term “implements”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “the set of the first functional units of the first kit of the drive system implements” to be “the set of the first functional units of the first kit of the drive system is configured to implement”. Examiner suggests replacing “the set of the first functional units of the first kit of the drive system implements” in line 2-3 of claim 2 with “the set of the first functional units of the first kit of the drive system is configured to implement”.
Line 2-4 recites “the set of the first functional units of the first kit of the drive system implements the stimulation mode for triggering the milk ejection reflex and the different expression mode”. Claim 2 is dependent on claim 19 and claim 1. Claim 1 recites “wherein the first set of functional units of the first kit constitutes a drive system for implementing at least one of a stimulation mode for triggering a milk ejection reflex an expression mode for milk expression”. It is unclear based on claim 1, if “the different expression mode” is the same as “the expression mode for milk expression” in claim 1. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the different expression mode” in line 4 of claim 2 with “the expression mode for milk expression”. Additionally, claim 2 depends on claim 19 and claim 1. Claim 19 states that the set of first functional units and the set of second functional units constitutes the drive system for implementing the at least one stimulation mode for triggering the milk ejection reflex or the different expression mode. Claim 2 then appears to state that the set of first functional units implements the stimulation mode and the different expression mode. It is unclear how both the set of first functional units and the set of second functional units are required in claim 19, while claim 2 then further states only the set of first functional units are needed to perform the same function already defined as being performed by the set of first functional units and the set of second functional units in claim 19. It is unclear if the second kit is required to constitute the drive system based on the limitations of claim 2. Examiner suggests clarifying which set of functional units implements which functions.
Examiner notes claims 3-5 are similarly rejected by virtue of their dependency on claim 2.
In regard to claim 3,
Line 1-2 recites “the set of functional units of the second kit”. It is unclear if the functional units of the second kit are the same as the second functional units of the second kit introduced in claim 19. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the set of functional units of the second kit” with “the set of second functional units of the second kit”.
Line 1-3 recites “the set of the functional units of the second kit of the drive system implements”. It is unclear if a method step is being claimed due to the term “implements”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “the set of the functional units of the second kit of the drive system implements” to be “the set of the second functional units of the second kit of the drive system is configured to implement”. Examiner suggests replacing “the set of the functional units of the second kit of the drive system implements” in line 1-3 of claim 3 with “the set of the second functional units of the second kit of the drive system is configured to implement”.
Line 1-3 “the set of functional units of the second kit of the drive system implements the expression mode”. Claim 3 is dependent on claim 2, 19, and 1. Claim 19 introduces a set of second functional units. Claim 19 further states “wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system for implementing the at least one of the stimulation mode for triggering the milk ejection reflex or the different expression mode”. It is unclear if the expression mode in claim 3 is the same as the different expression mode in claim 19. Claim 1 also states that the set of first functional units is for implementing the expression mode, not the set of functional units of the second kit. For examination purposes Examiner construes the set of second functional units to be configured to implement the expression mode in conjunction with the set of first functional units.
Examiner notes claims 4-5 are similarly rejected by virtue of their dependency on claim 3.
In regard to claim 4,
Line 5-6 recites “the second kit is configured to generate a pressure waveform for use during the expression mode”. Claim 4 is dependent on claim 3, 2, 19, and 1. Claim 19 introduces a set of second functional units. Claim 19 further states “wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system for implementing the at least one of the stimulation mode for triggering the milk ejection reflex or the different expression mode”. It is unclear if the expression mode in claim 4 is the same as the different expression mode in claim 19. Claim 1 also states that the set of first functional units is for implementing the expression mode, not the set of functional units of the second kit. For examination purposes Examiner construes the set of second functional units to be configured to implement the expression mode in conjunction with the set of first functional units.
In regard to claim 17,
Line 1-2 recites “wherein the first kit implements the stimulation mode”. It is unclear if a method step is being claimed due to the term “implements”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “wherein the first kit implements the stimulation mode” to be “wherein the first kit is configured to implement the stimulation mode”. Examiner suggests replacing “wherein the first kit implements the stimulation mode” in line 1-2 of claim 17 with “wherein the first kit is configured to implement the stimulation mode”.
In regard to claim 18,
Line 1-2 recites “wherein the stimulation mode has a faster frequency and a shorter cycle time than the expression mode”. Claim 18 depends on claim 1. Claim 1 does not necessarily require a stimulation mode due to the term “at least one of”. It is unclear if claim 18 is intending to positively require the stimulation mode and the expression mode due to further limiting the stimulation mode relative to the expression mode. For examination purposes Examiner construes the stimulation mode to not be positively required. Examiner suggests clarifying and claiming which modes are required in claim 18 before further limiting the modes.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 19, 6, 20, 7 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a first embodiment of Makower (U.S. PG publication 20200155738). It is noted that claims 2-5, 7, and 11 depend on claim 19. For clarity purposes the rejection of claim 19 appears before the rejection of claims 2-5, 7, and 11. It is also noted that claim 7 depends on claim 20. For clarity purposes the rejection of claim 20 appears before the rejection of claim 7.
In regard to claim 1,
A first embodiment of Makower discloses a breast pump system (see figure 21 wherein two devices/pumps are shown which form a system and paragraph [0187]; Examiner notes the battery 48 is provided only in one pump, see also paragraph [0185] which describes how the controller interacts with the pumps; paragraph [0188] also provides alternate configurations) comprising:
a first kit (main body 34 of the left side pump, battery 48, controller 52 provided in the left side pump, and the components within item 34 of the left side pump which enable milk expression as detailed in paragraph [0185]) having a respective set of first functional units (controller, battery, and pumping components) which thereby define a set of first functional capabilities of the first kit (see analysis above where the controller, battery, and pumping components define a set of first functional capabilities of the first kit; paragraph [0185]).
wherein at least some of the first functional units are modular (Examiner notes the term “modular” as defined by Cambridge Dictionary means “consisting of separate parts that, when combined, form a complete whole; see analysis above, where the controller, battery, and pumping components are modular and are assembled within the main body) such that the first kit is configurable by a user to select different functional units for the set of first functional units (see 112 rejection above for claim interpretation wherein Examiner construes “such that the first kit is configurable by a user to select different functional units for the set of first functional units” to be “such that some of the at least some of first functional units that are modular can be selected by a user to provide a number of the first functional capabilities”. Each modular component can be selected to provide a number of the first functional capabilities as each modular component has a separate function and can function together. Examiner notes the claim does not require interchangeable first functional units), and
wherein the set of first functional units of the first kit constitutes a drive system (see 112 rejection above for claim interpretation wherein “wherein the set of first functional units of the first kit constitutes a drive system” is construed as “wherein the set of first functional units of the first kit constitutes a portion of a drive system”; see paragraph [0185]) for implementing at least one of a stimulation mode for triggering a milk ejection reflex an expression mode for milk expression (see 112 rejection above for claim interpretation wherein “for implementing at least one of a stimulation mode for triggering a milk ejection reflex an expression mode for milk expression” is construed to be “for implementing at least one of a stimulation mode for triggering a milk ejection reflex or an expression mode for milk expression; The drive system is for implementing an expression mode for milk expression; see paragraph [0185] and analysis above wherein milk is expressed).
In regard to claim 19,
The first embodiment of Makower discloses the breast pump system of claim 1, further comprising:
a second kit (main body 34 on the right side pump, controller 52 and the components within item 34 of the right side pump which enable milk expression as detailed in paragraph [0185]), having a respective set of second functional units (controller 52 and the components within item 34 of the right side pump which enable milk expression) which thereby define a set of second functional capabilities of the second kit (see analysis above where the second functional define a set of second functional capabilities of the second kit),
wherein at least some of the second functional units are modular (controller 52 and the components within item 34 of the right side pump which enable milk expression are modular and are assembled within the main body of the second kit) such that the second kit is configurable by the user to select different functional units for the set of first functional units (see 112 rejection above for claim interpretation wherein Examiner construes “such that the second kit is configurable by the user to select different functional units for the set of first functional units” to be “such that some of the at least some of second functional units that are modular can be selected by a user to provide a number of the second functional capabilities”. Each modular component can be selected to provide a number of the second functional capabilities as each modular component has a separate function and can function together. Examiner notes the claim does not require interchangeable second functional units), and
wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system for implementing the at least one of the stimulation mode for triggering the milk ejection reflex or the different expression mode (see 112 rejection above for claim interpretation; wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system for implementing the expression mode; see paragraph [0185] and analysis above wherein milk is expressed).
In regard to claim 6,
The first embodiment of Makower discloses the breast pump system of claim 1, wherein the set of functional units of the first kit includes one of more features selected from a list of: a battery; an electrical pump; a mechanical system for generating a constant baseline under-pressure; a system for generating a pressure waveform during the stimulation mode for triggering the milk ejection reflex; a system for generating a pressure waveform during the expression mode; a system for generating a pressure waveform during a massage mode; a milk collection vessel; a user input interface for receiving user commands; a user output interface for providing status information to a user; a communications interface for communicating wirelessly with an external device; a milk sensor; a timer; and an ambient condition sensor (see analysis of claim 1 wherein the set of functional units of the first kit includes a battery, and a system for generating a pressure waveform during the expression mode).
In regard to claim 20,
The first embodiment of Makower discloses the breast pump system of claim 19, wherein the first and second kits have matching outer shapes (see figure 21 wherein the outer shape of the main body 34 of the first kit and second kit are matching).
In regard to claim 7,
The first embodiment of Makower discloses the breast pump system of claim 20, wherein the first and second kits are for fitting to a feeding bra with a same cup size (paragraph [0007]-[0008] and [0174]; Examiner notes “for fitting to a feeding bra with a same cup size” is a functional limitation. A feeding bra with a same cup size is not positively required by the claim. The first and second kits are fully capable of the recited function due to their structure and shape).
In regard to claim 18,
The first embodiment of Makower discloses the breast pump system of claim 1, wherein the stimulation mode has a faster frequency and a shorter cycle time than the expression mode (see 112 rejection above for claim interpretation where the stimulation mode is not positively required by the claim. A stimulation mode having a faster frequency and a shorter cycle time than the expression mode is fully capable).
Claims 1, 19, 6, 20, 7-8, 11, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a fifth embodiment of Makower (U.S. PG publication 20200155738). It is noted that claims 2, 7, and 11 depend on claim 19. For clarity purposes the rejection of claim 19 appears before the rejection of claims 2, 7, and 11. It is also noted that claim 7 depends on claim 20. For clarity purposes the rejection of claim 20 appears before the rejection of claim 7. Additionally, it is noted that the embodiment referred to as the fifth embodiment is being referred to as the fifth embodiment as introduced in the Non-final Office action mailed 3/25/2026 for consistency/clarity purposes.
In regard to claim 1,
A fifth embodiment of Makower discloses a breast pump system (see figure 23 wherein one pump is attached to one of the users breasts and a skin contact member is attached to the other breast; paragraph [0189]; see also paragraph [0149] wherein skin contact member 10 can be made from a compressible member) comprising:
a first kit (main body 34 and the components within item 34 which enable milk expression as detailed in paragraph [0189]) having a respective set of first functional units (components within item 34 which enable milk expression as detailed in paragraph [0189]) which thereby define a set of first functional capabilities of the first kit (see analysis above where the components within item 34 which enable milk expression as detailed in paragraph [0189] define a set of first functional capabilities of the first kit).
wherein at least some of the first functional units are modular (Examiner notes the term “modular” as defined by Cambridge Dictionary means “consisting of separate parts that, when combined, form a complete whole; see analysis above, where the components within item 34 which enable milk expression modular and are assembled within the main body) such that the first kit is configurable by a user to select different functional units for the set of first functional units (see 112 rejection above for claim interpretation wherein Examiner construes “such that the first kit is configurable by a user to select different functional units for the set of first functional units” to be “such that some of the at least some of first functional units that are modular can be selected by a user to provide a number of the first functional capabilities”. Each modular component can be selected to provide a number of the first functional capabilities as each modular component has a separate function and can function together. Examiner notes the claim does not require interchangeable first functional units), and
wherein the set of first functional units of the first kit constitutes a drive system (see 112 rejection above for claim interpretation wherein “wherein the set of first functional units of the first kit constitutes a drive system” is construed as “wherein the set of first functional units of the first kit constitutes a portion of a drive system”; see paragraph [0189]) for implementing at least one of a stimulation mode for triggering a milk ejection reflex an expression mode for milk expression (see 112 rejection above for claim interpretation wherein “for implementing at least one of a stimulation mode for triggering a milk ejection reflex an expression mode for milk expression” is construed to be “for implementing at least one of a stimulation mode for triggering a milk ejection reflex or an expression mode for milk expression; The drive system is for implementing an expression mode for milk expression; see paragraph [0189] and analysis above wherein milk is expressed).
In regard to claim 19,
The fifth embodiment of Makower discloses the breast pump system of claim 1, further comprising:
a second kit (housing of the skin contact member 10 and sensor 54 within the skin contact member shown in figure 24), having a respective set of second functional units (sensor 54 and housing) which thereby define a set of second functional capabilities of the second kit (see analysis above where the second functional define a set of second functional capabilities of the second kit),
wherein at least some of the second functional units are modular (sensor 54 and the housing are modular and can be assembled together to form the second kit) such that the second kit is configurable by the user to select different functional units for the set of first functional units (see 112 rejection above for claim interpretation wherein Examiner construes “such that the second kit is configurable by the user to select different functional units for the set of first functional units” to be “such that some of the at least some of second functional units that are modular can be selected by a user to provide a number of the second functional capabilities”. Each modular component can be selected to provide a number of the second functional capabilities as each modular component has a separate function and can function together. Examiner notes the claim does not require interchangeable second functional units), and
wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system for implementing the at least one of the stimulation mode for triggering the milk ejection reflex or the different expression mode (see 112 rejection above for claim interpretation; wherein the set of second functional units of the second kit, together with the set of first functional units of the first kit, constitutes the drive system for implementing the expression mode; see paragraph [0189] and analysis above wherein milk is expressed).
In regard to claim 6,
The fifth embodiment of Makower discloses the breast pump system of claim 1, wherein the set of functional units of the first kit includes one of more features selected from a list of: a battery; an electrical pump; a mechanical system for generating a constant baseline under-pressure; a system for generating a pressure waveform during the stimulation mode for triggering the milk ejection reflex; a system for generating a pressure waveform during the expression mode; a system for generating a pressure waveform during a massage mode; a milk collection vessel; a user input interface for receiving user commands; a user output interface for providing status information to a user; a communications interface for communicating wirelessly with an external device; a milk sensor; a timer; and an ambient condition sensor (see analysis of claim 1 wherein the set of functional units of the first kit includes at least a system for generating a pressure waveform during the expression mode).
In regard to claim 20,
The fifth embodiment of Makower discloses the breast pump system of claim 19, wherein the first and second kits have matching outer shapes (see figure 23 wherein the outer shapes of the first and second kits are both circles and therefore are matching).
In regard to claim 7,
The fifth embodiment of Makower discloses the breast pump system of claim 20, wherein the first and second kits are for fitting to a feeding bra with a same cup size (paragraph [0007]-[0008] and [0174]; Examiner notes “for fitting to a feeding bra with a same cup size” is a functional limitation. A feeding bra with a same cup size is not positively required by the claim. The first and second kits are fully capable of the recited function due to their structure and shape).
In regard to claim 8,
The fifth embodiment of Makower discloses the breast pump system of claim 1, wherein the first kit is attached to a milk collecting vessel (figure 24, item 60).
In regard to claim 11,
The fifth embodiment of Makower discloses the breast pump system of claim 19, wherein only one of the first and second kits has an electrical pump (see pump of first kit; paragraph [0189]), and the other one of the first and second kits (second kit) has a mechanical system for generating a constant baseline under-pressure (see analysis of claim 1 above wherein item 10 functions as a mechanical system for generating a constant baseline under-pressure as item 10 is a compressible member as supported by paragraph [0149]. Examiner notes the sensor within item 10 can also function with the controller to generate a constant baseline under-pressure. Examiner notes “for generating a constant baseline under-pressure” is a functional limitation. The mechanical system is fully capable of the recited function due to its structure).
In regard to claim 18,
The fifth embodiment of Makower discloses the breast pump system of claim 1, wherein the stimulation mode has a faster frequency and a shorter cycle time than the expression mode (see 112 rejection above for claim interpretation where the stimulation mode is not positively required by the claim. A stimulation mode having a faster frequency and a shorter cycle time than the expression mode is fully capable).
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.
Claims 2-5 and 16 rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Makower (U.S. PG publication 20200155738) further in view of a second embodiment of Makower (U.S. PG publication 20200155738).
In regard to claim 2,
The first embodiment of Makower discloses the breast pump system of claim 19, wherein: the set of first functional units of the first kit of the drive system implements the different expression mode (see analysis of claim 19 and 1 above).
The first embodiment of Makower fails to disclose wherein: the set of first functional units of the first kit of the drive system implements the stimulation mode for triggering the milk ejection reflex.
A second embodiment of Makower teaches a set of functional units (figure 34, item 3400, 3404, and 46) of a kit (see pumping device of figure 34) of the drive system implements the stimulation mode for triggering the milk ejection reflex (paragraph [0214]: wherein the vibration provides stimulation).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify each pump of the first embodiment to include vibration members 3400 and the necessary components to vibrate the vibration members, as taught by the second embodiment of Makower, for the purpose of facilitating milk extraction (paragraph [0214]). It is noted that although both pumps of the first embodiment contain the vibration members as modified by the second embodiment of Makower, the set of functional units for implementing a stimulation mode (the vibration members and the necessary components to vibrate the vibration members) only in the first pump are construed as being units of the first functional units of the first kit while the vibration members within the second pump are not construed as being a part of the second functional units of the second kit. The set of second functional units of the second kit has no stimulation mode as the second functional units only contain, a controller, and the pumping components for milk expression in the right side pump. Modifying the first embodiment of Makower in view of the second embodiment of Makower therefore results in wherein: the set of first functional units of the first kit of the drive system implements the stimulation mode for triggering the milk ejection reflex. Claim 2 does not preclude other components of the breast pump system to be present that are separate from the claimed functional units of each of the first kit and the second kit.
In regard to claim 3,
The first embodiment of Makower in view of the second embodiment of Makower teaches the breast pump system of claim 2, wherein the set of functional units of the second kit of the drive system implements the expression mode but no separate stimulation mode (see 112 rejection above for claim interpretation; see analysis of claim 2 and 19 above).
In regard to claim 4,
The first embodiment of Makower in view of the second embodiment of Makower teaches the breast pump system of claim 3, wherein:
the first kit is configured to generate a pressure waveform for use during the stimulation mode for triggering the milk ejection reflex (paragraph [0214] and [0198]; vibrating frequency waveform) and a different pressure waveform for use during an the expression mode (paragraph [0198], [0012], and [0185]; waveform used during milk expression); and
the second kit is configured to generate a pressure waveform for use during the expression mode (see 112 rejection above for claim interpretation; paragraph [0185] and [0012]; waveform used during milk expression) but no different pressure waveform for use during the stimulation mode for triggering the milk ejection reflex (see analysis of claim 3, 2, and 19 above).
In regard to claim 5,
The first embodiment of Makower in view of the second embodiment of Makower teaches the breast pump system of claim 3, wherein:
the first kit is configured to generate a mechanical contact pressure waveform for use during the stimulation mode for triggering the milk ejection reflex (paragraph [0214]).
In regard to claim 16,
The first embodiment of Makower discloses the breast pump system of claim 1.
The first embodiment of Makower fails to disclose wherein the set of first functional units of the first kit is configurable to additionally provide a massaging functionality and/or local milk collection functionality.
The second embodiment of Makower teaches a set of functional units (figure 34, item 3400, 3404, and 46) of a kit (see pumping device of figure 34) is configurable to additionally provide a massaging functionality (paragraph [0214]: wherein the vibration provides a massaging functionality).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify each pump of the first embodiment to include vibration members 3400 and the necessary components to vibrate the vibration members, as taught by the second embodiment of Makower, for the purpose of facilitating milk extraction (paragraph [0214]). It is noted that although both pumps of the first embodiment contain the vibration members as modified by the second embodiment of Makower, the set of functional units configurable to additionally provide a massaging functionality (the vibration members and the necessary components to vibrate the vibration members) only in the first pump are construed as being units of the set of first functional units of the first kit while the vibration members within the second pump are not construed as being a part of the second functional units of the second kit. Modifying the first embodiment of Makower in view of the second embodiment of Makower therefore results in wherein the set of first functional units of the first kit is configurable to additionally provide a massaging functionality and/or local milk collection functionality. Claim 16 does not preclude other components of the breast pump system to be present that are separate from the claimed functional units of each of the first kit and the second kit. Claim 1 also does not necessarily require the stimulation mode.
Claims 8-9 rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Makower (U.S. PG publication 20200155738) further in view of a third embodiment of Makower (U.S. PG publication 20200155738).
In regard to claim 8,
The first embodiment of Makower discloses the breast pump system of claim 1.
The first embodiment Makower is silent as to wherein the first kit is attached to a milk collecting vessel.
A third embodiment of Makower teaches wherein a kit (see figure 1B) is attached to a milk collecting vessel (item 60; paragraph [0157]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify each kit of the first embodiment of Makower to be attached to a milk collecting vessel, as taught by the third embodiment of Makower, therefore resulting in wherein the first kit is attached to a milk collecting vessel for the purpose of storing milk (paragraph [0008] of Makower).
In regard to claim 9,
The first embodiment of Makower discloses the breast pump system of claim 1, wherein the drive system comprises a controller (figure 21, item 52).
The first embodiment of Makower is silent as to wherein the drive system comprises a valve and a controller for controlling the valve.
The third embodiment of Makower teaches wherein the drive system comprises a valve (item 50) and a controller for controlling the valve (paragraph [0156]; Examiner notes the controller controls the valve as the controller controls the vacuum levels which as a result controls the flow of milk which controls whether the valve is open or closed. When the controller enables milk flow, the valve is opened via the milk flow. If the controller does not enable milk flow, the valve is closed).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the drive system to comprise a valve and to modify the controller for controlling the valve of the first embodiment of Makower, as taught by the third embodiment of Makower, therefore resulting in wherein the drive system comprises a valve and a controller for controlling the valve for controlling the valve for the purpose of preventing back flow or milk (paragraph [0157] of Makower).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Makower (U.S. PG publication 20200155738) further in view of Dellimore (EP 3520831). See attached copy of EP 3520831.
In regard to claim 10,
The first embodiment of Makower discloses the breast pump system of claim 1.
The first embodiment of Makower fails to disclose wherein: the first kit has: a user input interface and a user output interface; and/or a noise sensor.
Dellimore teaches wherein: the first kit (see figure 1) has: a user input interface and a user output interface; and/or a noise sensor (acoustic sensor 61 which processor 62 processes an acoustic signal received from the sensor; paragraph [0010]-[0011] and [0039]-[0040])
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Makower to include a noise sensor and processor configured to process an acoustic signal received from the noise sensor, as taught by Dellimore, for the purpose of automatically determining an expressed milk volume (paragraph [0011] of Dellimore).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Makower (U.S. PG publication 20200155738) further in view of Elad (U.S. PG publication 20170368244).
In regard to claim 17,
The first embodiment of Makower discloses the breast pump system of claim 1.
The first embodiment of Makower fails to disclose wherein the first kit implements the stimulation mode for triggering the milk ejection reflex by cycling a vacuum under control of a controller.
Elad teaches wherein a kit implements the stimulation mode for triggering the milk ejection reflex by cycling a vacuum under control of a controller (paragraph [0062]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first kit of the first embodiment of Makower to include the first kit implements the stimulation mode for triggering the milk ejection reflex by cycling a vacuum under control of a controller, as taught by Elad, for the purpose of mimicking the suckling action of an infant during breastfeeding (paragraph [0062] of Elad).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over the first embodiment of Makower (U.S. PG publication 20200155738) further in view of a fourth embodiment of Makower (U.S. PG publication 20200155738).
In regard to claim 21,
The first embodiment of Makower discloses the breast pump system of claim 19, wherein the first kit and the second kit are coupled together by a wired connection (see figure 21, item 2012).
The first embodiment of Makower fails to disclose wherein only one of the first kit or the second kit has a communications interface for communicating wirelessly with an external device.
A fourth embodiment of Makower teaches a kit (figure 28, item 100) has a communications interface (figure 28, item 472) for communicating wirelessly with an external device (figure 28, item 470).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify one of the first kit or second kit to include a communications interface for communicating wirelessly with an external device, as taught by the fourth embodiment of Makower, therefore resulting in wherein only one of the first kit or the second kit has a communications interface for communicating wirelessly with an external device for the purpose of sending data (paragraph [0197]). It is noted Makower also supports a configuration (see figure 22) where only one controller is present between each of the first kit and second kit (see paragraph [0188]).
Claims 2 and 16 rejected under 35 U.S.C. 103 as being unpatentable over the fifth embodiment of Makower (U.S. PG publication 20200155738) in view of the second embodiment of Makower (U.S. PG publication 20200155738).
In regard to claim 2,
The fifth embodiment of Makower discloses the breast pump system of claim 19, wherein: the set of first functional units of the first kit of the drive system implements the different expression mode (see analysis of claim 19 and 1 above).
The fifth embodiment of Makower fails to disclose wherein: the set of first functional units of the first kit of the drive system implements the stimulation mode for triggering the milk ejection reflex.
The second embodiment of Makower teaches a set of functional units (figure 34, item 3400, 3404, and 46) of a kit (see pumping device of figure 34) of the drive system implements the stimulation mode for triggering the milk ejection reflex (paragraph [0214]: wherein the vibration provides stimulation).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first pump of the fifth embodiment to include vibration members 3400 and the necessary components to vibrate the vibration members, as taught by the second embodiment of Makower, for the purpose of facilitating milk extraction (paragraph [0214]). It is noted that the set of functional units for implementing a stimulation mode (the vibration members and the necessary components to vibrate the vibration members) in the first pump are construed as being units of the first functional units of the first kit. Modifying the first embodiment of Makower in view of the second embodiment of Makower therefore results in wherein: the set of first functional units of the first kit of the drive system implements the stimulation mode for triggering the milk ejection reflex.
In regard to claim 16,
The fifth embodiment of Makower discloses the breast pump system of claim 1.
The fifth embodiment of Makower fails to disclose wherein: wherein the set of first functional units is configurable to additionally provide massaging functionality and/or local milk collection functionality.
The second embodiment of Makower teaches a set of functional units (figure 34, item 3400, 3404, and 46) of a kit (see pumping device of figure 34) is configurable to additionally provide a massaging functionality (paragraph [0214]: wherein the vibration provides a massaging functionality).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first pump of the fifth embodiment to include vibration members 3400 and the necessary components to vibrate the vibration members, as taught by the second embodiment of Makower, for the purpose of facilitating milk extraction (paragraph [0214]). Modifying the first embodiment of Makower in view of the second embodiment of Makower therefore results in wherein the set of first functional units is configurable to additionally provide massaging functionality and/or local milk collection functionality.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the fifth embodiment of Makower (U.S. PG publication 20200155738) further in view of Dellimore (EP 3520831). See attached copy of EP 3520831.
In regard to claim 10,
The fifth embodiment of Makower discloses the breast pump system of claim 1.
The fifth embodiment of Makower fails to disclose wherein: the first kit has: a user input interface and a user output interface; and/or a noise sensor.
Dellimore teaches wherein: the first kit (see figure 1) has: a user input interface and a user output interface; and/or a noise sensor (acoustic sensor 61 which processor 62 processes an acoustic signal received from the sensor; paragraph [0010]-[0011] and [0039]-[0040])
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the fifth embodiment of Makower to include a noise sensor and processor configured to process an acoustic signal received from the noise sensor, as taught by Dellimore, for the purpose of automatically determining an expressed milk volume (paragraph [0011] of Dellimore).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over the fifth embodiment of Makower (U.S. PG publication 20200155738) further in view of Elad (U.S. PG publication 20170368244).
In regard to claim 17,
The fifth embodiment of Makower discloses the breast pump system of claim 1.
The fifth embodiment of Makower fails to disclose wherein the first kit implements the stimulation mode for triggering the milk ejection reflex by cycling a vacuum under control of a controller.
Elad teaches wherein a kit implements the stimulation mode for triggering the milk ejection reflex by cycling a vacuum under control of a controller (paragraph [0062]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first kit of the fifth embodiment of Makower to include the first kit implements the stimulation mode for triggering the milk ejection reflex by cycling a vacuum under control of a controller, as taught by Elad, for the purpose of mimicking the suckling action of an infant during breastfeeding (paragraph [0062] of Elad).
Response to Arguments
Applicant's arguments filed 7/24/2026 have been fully considered but they are not persuasive.
Applicant argues in regard to the drawings that replacement sheets have been included. As noted above and shown below, a copy of figure 1 does not appear to be included.
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Applicant argues in regard to the rejections under 112 that the rejections are moot in view of the revisions to the claims. As detailed above, the rejection of claim 2 under 35 U.S.C. 112 was not overcome as it is still unclear if the second kit is required to constitute the drive system based on the limitations of claim 2. It is also unclear how both the set of first functional units and the set of second functional units are required in claim 19, while claim 2 then further states only the set of first functional units are needed to perform the same function already defined as being performed by the set of first functional units and the set of second functional units in claim 19. Accordingly, the rejection of claim 2 under 35 U.C.S. 112 remains.
Applicant argues that the first embodiment of Makower fails to disclose one embodiment in which each kit includes functional units that are modular, such that the kit is configurable by a user to select different functional units. The term “modular” as defined by Cambridge Dictionary means “consisting of separate parts that, when combined, form a complete whole”. It is Examiner’s position that the controller, battery, and pumping components of the first kit are modular as they are separate parts that when assembled within the main body form the first kit i.e. the whole. Additionally, as detailed above, the limitation “wherein at least some of the first functional units are modular such that the first kit is configurable by a user to select different functional units for the set of first functional units” necessitates a 112 rejection. Examiner suggests clarifying what is meant by “wherein at least some of the first functional units are modular such that the first kit is configurable by a user to select different functional units for the set of first functional units” as the first kit does not select different functional units. Examiner suggests clarifying that the first functional units that are modular are interchangeable or reconfigurable as claim 1 as currently claimed does not necessarily require the first functional units to be interchangeable or reconfigurable.
Applicant argues in regard to the fifth embodiment of Makower that the skin contact member 10 does not teach a kit that includes a set of functional units. It is noted that the skin contact member 10 was not construed as the first kit, but was rather construed as part of the second kit in claim 19. The housing of the skin contact member 10 and the sensor 54 within the skin contact member shown in figure 24 constitutes a second kit with second functional units which thereby define a set of second functional capabilities as the housing and sensor both have distinct functions.
Applicant argues that claims 2-11 and new claims 16-21 are allowable at least because they depend from independent claim 1. See response to arguments in regard to claim 1 above.
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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
