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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 29, 2026, has been entered.
Acknowledgments
In the reply, filed on April 29, 2026, Applicant requested the consideration of the amendment of March 19, 2026. The amendment is now considered.
Applicant amended claims 1, 9-11, 14, 17, and 20.
In the final rejection of January 29, 2026, Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 9-11 and 20. Applicant amended claims 9-11 and 20; however, Applicant did not address all of the objections. Objection is maintained.
Currently, claims 1-2 and 4-20 are under examination.
Claim Objections
Claim 9 is objected to because of the following informalities:
In regards to claim 9, line 3, “the air passage element” should be changed to “an air passage element”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1-2, 4-7, 9, 14, 17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farka et al (US 2010/0121263).
In regards to claim 1, Farka et al teaches a cushion (Figures 1-9, elastic system 100) configured to be mounted to an air passage element of a breast pump device and to contact a breast of a user of the breast pump device, the cushion comprising:
a breast-facing section (110) at one side of the cushion
a pump section (130) at another side of the cushion, wherein the pump section includes a contacting surface (131) configured to contact a surface of the air passage element
a stretching section (120) positioned between the breast-facing section and the pump section, the stretching section having one or more folded areas (labeled in Figures 6 and 9 below)
wherein the cushion is generally sleeve shaped and configured to be deformable and/or movable from an initial configuration to a final configuration, while the contacting surface maintains sliding contact with the surface of the air passage element (131 is structurally capable of performing the intended use of maintaining sliding contact with the surface of the air passage element), when the cushion is brought under influence of underpressure acting on the cushion from a side of the pump section (Figures 1-9)
wherein the cushion is further configured to be stretchable in a generally axial direction, between the breast-facing section and the pump section, under the influence of the underpressure acting on the cushion from the side of the pump section (Figure 8)
wherein the one or more folded areas of the stretching section are configured to deform from a more compact configuration in the initial configuration of the cushion (Figure 9) to a more straightened configuration in the final configuration of the cushion in response to the underpressure acting on the cushion to stretch the cushion in the generally axial direction (Figure 8)
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In regards to claim 2, Farka et al teaches wherein the cushion is configured to be at least partially arranged in the air passage element of the breast pump device and/or to be arranged to at least partially encompass the air passage element of the breast pump device, wherein the surface of the air passage element contacted by the contacting surface comprises an interior surface of the air passage element and/or an exterior surface of the air passage element (Figures 2-9).
In regards to claim 4, Farka et al teaches wherein the stretching section is deformable between the more compact configuration (Figure 9) and the more straightened configuration and thereby being configured to facilitate stretching of the cushion (Figure 8).
In regards to claim 5, Farka et al teaches wherein the pump section includes a stiffened annular portion (131), wherein the contacting surface comprises at least a portion of a surface of the pump section at a position of the stiffened annular portion (Figures 1-9).
In regards to claim 6, Farka et al teaches wherein the breast-facing section includes a coupling portion (111) configured to engage with the air passage element (Figures 2-9).
In regards to claim 7, Farka et al teaches wherein the coupling portion comprises a groove (111) configured to receive and accommodate a peripheral front edge of the air passage element (Figures 2-9).
In regards to claim 9, Farka et al teaches an assembly (Figures 1-9, system 500) comprising the cushion (100) according to claim 1 and a breast pump device (200), wherein the contacting surface of the pump section of the cushion is in sealing contact with a surface of the air passage element of the breast pump device when the cushion is coupled to the air passage element of the breast pump device and is either in the initial configuration or the final configuration (Figures 2-9).
In regards to claim 14, Farka et al teaches a breast pump device (Figures 1-9, system 500), comprising:
an expression unit including an air passage element (210), the expression unit being configured to allow a cushion to be mounted to the air passage element, wherein the cushion is generally sleeve-shaped and comprises a breast-facing section at one side of the cushion facing a breast, and a pump section at another side of the cushion, and a stretching section positioned between the breast-facing section and the pump section, the stretching section having one or more folded areas, wherein the pump section includes a contacting surface configured to contact a surface of the air passage element (Figures 2-9)
a vacuum unit (230) configured to realize a pressure cycle in the expression unit, the vacuum unit being connectable to the expression unit and including a pump mechanism (230) configured to suck air from the expression unit to generate an underpressure acting on the cushion (Figure 8)
a controller configured to control operation of the breast pump device during a pumping session (paragraph [0021]: The pump's suction strength and cycling rate are also important factors. Breastpumps with high suction pressure and cycling rate), the controller being programmed to drive the pump mechanism for creating a vacuum boost at a start of the pumping session effective to deform and/or move the cushion from an initial configuration to a final configuration, while the contacting surface maintains sliding contact with the surface of the air passage element (210 is structurally capable of accommodating performance of the intended use of the contacting surface maintaining sliding contact with the surface of the air passage element), when the cushion is positioned with respect to the air passage element and brought under influence of the underpressure acting on the cushion, wherein the cushion is configured to be stretchable in a generally axial direction, between the breast-facing section and the pump section, under the influence of the underpressure (Figure 8)
wherein the one or more folded areas of the stretching section are configured to deform from a more compact configuration (Figure 9) to a more straightened configuration in response to the underpressure acting on the cushion to stretch the cushion in the generally axial direction (Figure 8)
In regards to claim 17, Farka et al teaches wherein the breast-facing section includes a coupling portion (111) configured to couple to a peripheral front edge of the air passage element.
In regards to claim 20, Farka et al teaches a breast pump device (Figures 1-9, system 500), comprising:
the cushion (100) according to claim 1
an expression unit including an air passage element (210), wherein the expression unit is configured to allow the cushion to be mounted to the air passage element (Figures 2-9)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Farka et al, as applied to claim 1 above, and further in view of Silver et al (US 2011/0071466).
In regards to claim 8, Farka et al does not teach a valve configured to at least hinder an airflow through the cushion when the cushion is not disposed in the final configuration. Silver et al teaches a cushion (Figure 7, breastshield 70) comprising a valve (78) configured to at least hinder an airflow through the cushion when the cushion is not disposed in a final configuration (Figure 7 – inner sidewall 74 in solid line configuration). 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 cushion, of Farka et al, with a valve, as taught by Silver et al, as such will open, so milk passes through the valve, and is transported to the milk container (paragraph [0081]) and can serve to yield a baseline vacuum being maintained in the cushion, closing at a predetermined negative pressure (paragraph [0083]).
Response to Arguments
Applicant's arguments filed March 19, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: In response, the Final Office Action asserts that "[t]he more compact configuration of the cushion shown in Figure 9 is capable of being the initial configuration ...." See Final Office Action, p. 11. This simply is not the case. Farka et al. specifically identifies Fig. 7 as the configuration before the breast has been inserted and thus before application of the vacuum (initial configuration). See, e.g., para. [0080] ("The elastic system's (100) mid and lower diameter before it is formed, differentiated and adapted on the breast, is smaller than the diameter of the nipple end."). Fig. 8 is the configuration during application of the vacuum (final configuration). See, e.g., para. [0081] ("According to FIG. 8, with the application of vacuum (constant/periodic) through the vacuum supply (200), ... the elastic system (100) forms, differentiates, seals and adapts to the shape, anatomy and physiology of the breastfeeding mother's breast ....") (emphasis added). Fig. 9 simply shows how the elastic system 100 looks after the vacuum is removed and the breast is being physically pulled out of the upper area 110. See para. [0087] ("As shown in FIG. 9, after the milk elicitation, the system (500) removal supports the process of return to the breast in its physiological condition.") (emphasis added). Also, Fig. 6 is still irrelevant since it shows a different embodiment (a system for extracting milk from an utter, and not from a human breast) (Remarks/Discussion of Issues, pages 11-12). Examiner disagrees. With respect to an initial configuration, claim 1 structurally requires: a more compact configuration in the initial configuration of the cushion. Farka et al teaches a more compact configuration of the cushion (100) in Figure 9 that is structurally capable of being the initial configuration.
In regards to claim 1, Applicant argued: However, without acquiescing to the grounds of rejection and in order to further prosecution, Applicant has revised claim 1 to recite that the cushion is configured to be deformable and/or movable from an initial configuration to a final configuration "while the contacting surface maintains sliding contact with the surface of the air passage element." This revision is similar to allowed claim 11, which recites in part: "the cushion being arranged to deform and/or move from an initial configuration in which the contacting surface makes annular contact with the interior surface of the air passage element and an end of the cushion at a side of the pump section does not abut against the abutment surface of the expression unit, to a final configuration in which the contacting surface maintains the annular contact with the interior surface of the air passage element and the end of the cushion abuts against the abutment surface of the expression unit." The revision is also similar claim 17, which recited that "the contacting surface is configured to slide along the surface of the air passage element when the cushion is being stretched in the generally axial direction." (Emphasis added). In rejecting claim 17, the Final Office Action asserts in part: "Farka et al teaches ... wherein the contacting surface is configured to slide along the surface of the air passage element when the cushion is being stretched in the generally axial direction (Figure 9 to Figure 8)." See Final Office Action, p. 8. However, in both Figs. 8 and 9, the lower end area 131 (assertedly the "contacting surface") of the lower area 130 (assertedly the "pump section") of the elastic system 100 is shown not to be in contact with the vacuum supply 200 (apparently the "air passage element"). Further, the written description is unclear as to whether or how the lower end area 131 may contact the vacuum supply 200: "To provide an adequate application of the method, the lower end annular area's (131) vertical section surface may be circular, square, a combination of surfaces or an extension into a contact point with the vacuum supply (200) or directly to a milk collection receptacle. In specific applications of the elastic system (100) on long teats (like buffalos'), an extension may be fashioned in the annular area (131) of the elastic system (100), which may be fixed at least on one area of the vacuum supply (200) to assist in elastic system's (100) removal practices from the teat (not shown)." See para. [0064] (emphasis added). At most, Farka et al. may arguably disclose that the lower end area 131 contacts the vacuum supply 200 if some kind of extension is involved. However, such an extension would be not be slidable along the surface of the vacuum supply 200 since it would be fixed at least on one area. Therefore, there is no disclosure of the lower end area 131 being in sliding contact with the surface of the vacuum supply 200, or maintaining such sliding contact with the surface of the vacuum supply 200, while the elastic system 100 is deformed and/or moved from an initial configuration to a final configuration, as recited in claim 1 (Remarks/Discussion of Issues, pages 12-13). Examiner disagrees. In regards to claim 1, the claimed cushion positively recites a breast-facing section, a pump section including a contacting surface, and a stretching section having one or more folded areas. The claimed cushion does not require an air passage element of a breast pump device. Thus, the claimed cushion of Farka et al does not have to explicitly teach an air passage element of a breast pump device, and the contacting surface maintains sliding contact with the surface of the air passage element, as claimed, in order to anticipate the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The contacting surface (131) of Farka is structurally capable of performing the intended use of maintaining sliding contact with a surface of an air passage element, thus anticipating said limitation of the claim.
In regards to claim 14, Applicant argued: Applicant respectfully submits that Farka et al. does not disclose each and every element of claim 14 at least for substantially the same reasons set forth with regard to claim 1, and thus the rejection of claim 14 as being anticipated by Farka et al. under 35 U.S.C. § 102(a)(1) should be withdrawn (Remarks/Discussion of Issues, pages 13-14). Examiner disagrees. In regards to claim 14, the claimed breast pump device positively recites an expression unit including an air passage element, a vacuum unit, and a controller. The claimed breast pump device does not require a cushion comprising a breast-facing section, a pump section including a contacting surface, and a stretching section having one or more folded areas. Thus, the claimed breast pump device of Farka et al does not have to explicitly teach a cushion, and the contacting surface maintains sliding contact with the surface of the air passage element, as claimed, in order to anticipate the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The air passage element (210) of Farka et al is structurally capable of accommodating performance of the intended use of the contacting surface maintaining sliding contact with the surface of the air passage element, thus anticipating said limitation of the claim.
Allowable Subject Matter
Claims 10, 12-13, and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to dependent claim 10, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a breast pump device, as claimed, specifically including wherein the expression unit comprises at least one retaining element for receiving at least one displaceable part of the valve of the cushion under the influence of the underpressure acting on the cushion from the side of the pump section, the at least one retaining element being configured to deform the cushion from the initial configuration in which the at least one retaining element has not yet received the at least one displaceable part of the valve, to the final configuration in which the at least one retaining element has received the at least one displaceable part of the valve when the valve has opened.
Farka et al teaches a breast pump device (Figures 1-9, system 500) comprising an expression unit including an air passage element (210), the expression unit configured to allow the cushion according to claim 8 to be mounted to the air passage element (Figures 2-9). However, as Farka et al does not teach a valve, Farka et al does not teach wherein the expression unit comprises at least one retaining element for receiving at least one displaceable part of the valve of the cushion under the influence of the underpressure acting on the cushion from the side of the pump section, the at least one retaining element being configured to deform the cushion from the initial configuration in which the at least one retaining element has not yet received the at least one displaceable part of the valve, to the final configuration in which the at least one retaining element has received the at least one displaceable part of the valve when the valve has opened.
Silver et al teaches a breast pump device (Figure 7) comprising an expression unit including an air passage element (80), the cushion (74), and a valve (78). However, Silver et al does not teach wherein the expression unit comprises at least one retaining element for receiving at least one displaceable part of the valve of the cushion under the influence of the underpressure acting on the cushion from the side of the pump section, the at least one retaining element being configured to deform the cushion from the initial configuration in which the at least one retaining element has not yet received the at least one displaceable part of the valve, to the final configuration in which the at least one retaining element has received the at least one displaceable part of the valve when the valve has opened.
Thus, dependent claim 10 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1 and intervening claim 8. Dependent claims 12-13 and 15 are objected to by virtue of being dependent upon dependent claim 10.
Claims 11, 16, and 18-19 are allowed.
In regards to independent claim 11, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a breast pump device, as claimed, specifically including the cushion being arranged to deform and/or move from an initial configuration in which the contacting surface makes annular contact with the interior surface of the air passage element and an end of the cushion at the a side of the pump section does not abut against the abutment surface of the expression unit, to a final configuration in which the contacting surface maintains the annular contact with the interior surface of the air passage element and the end of the cushion abuts against the abutment surface of the expression unit.
Hiraoka (JP 2007-75293) teaches a breast pump device (Figures 1, 4-5), the cushion (40) being arranged to deform and/or move from an initial configuration in which an end of the cushion at a side of the pump section (44) does not abut against the abutment surface (23) of the expression unit (22/23) (Figure 4), to a final configuration in which the end of the cushion abuts against the abutment surface of the expression unit (Figure 5).
However, Hiraoka does not teach the cushion being arranged to deform and/or move from an initial configuration in which “the contacting surface makes annular contact with the interior surface of the air passage element” and an end of the cushion at the a side of the pump section does not abut against the abutment surface of the expression unit, to a final configuration in which “the contacting surface maintains the annular contact with the interior surface of the air passage element” and the end of the cushion abuts against the abutment surface of the expression unit.
Thus, independent claim 11 is allowed. Dependent claims 16 and 18-19 are allowed by virtue of being dependent upon dependent claim 11.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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