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 .
Acknowledgments
In the reply, filed on July 15, 2026, Applicant amended claims 1 and 14.
In the non-final rejection of May 14, 2026, Examiner objected to claim 9. Applicant argued: Applicant respectfully traverses the objection because "air passage element" refers back to the air passage element recited in claim 1, from which claim 9 depends. Therefore, claim 9 correctly recites the air passage element (Remarks/Discussion of Issues, page 9). Examiner disagrees. Claim 9, line 2 introduces “a breast pump device” of which an air passage element has not been previously introduced in claim 9. Thus, “the air passage element” in claim 9, line 3, of the breast pump device, should be changed to “an air passage element”. Objection is maintained.
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, occurring before application of underpressure acting on the cushion for receiving the breast, to a final configuration, occurring when the cushion is brought under influence of the underpressure acting on the cushion from a side of the pump section (Figures 1-9)
wherein the contacting surface is configured to maintain direct sliding contact with the surface of the air passage element while the cushion deforms and/or moves from the initial configuration to the final configuration (131 is structurally capable of performing maintaining direct sliding contact with the surface of the air passage element while the cushion deforms and/or moves from the initial configuration to the final configuration)
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, occurring before application of the underpressure acting on the cushion for receiving the breast, to a final configuration, 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 contacting surface is configured to maintain direct sliding contact with the surface of the air passage element while the cushion deforms and/or moves from the initial configuration to the final configuration (210 is structurally capable of accommodating performance of the contacting surface maintaining direct sliding contact with the surface of the air passage element while the cushion deforms and/or moves from the initial configuration to the final configuration)
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 July 15, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: The embodiment of Farka et al. relied on by the Office Action is a system for eliciting milk from a human breast shown in Figs. 7-9. Fig. 7 shows the elastic system 100 in an "initial configuration" before application of a vacuum by vacuum supply 200, and Fig. 8 shows the elastic system 100 in an "final configuration" after application of a vacuum by the vacuum supply 200 for extracting milk from the human breast. See paras. [0080]-[0081]. Fig. 9 shows the system after the vacuum has stopped, and the user's breast is being removed from the elastic system 100, and therefore does not indicate an initial or final configuration. 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). Fig. 6 is irrelevant since it shows a different embodiment than Figs. 7-9, i.e., a system for extracting milk from an utter as opposed to a human breast, and therefore should not be considered in an anticipation rejection. In response, the Office Action further asserts: "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) shown in Figure 9 that is structurally capable of being the initial configuration." See Office Action, p. 10. Applicant respectfully submits that this simply is not the case. Farka et al. specifically identifies Fig. 7 (not Fig. 9) as the configuration before application of the vacuum (initial configuration) for receiving the breast. 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) when the cushion is brought under influence of underpressure. 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). Under no circumstances is a configuration of the elastic system caused by breast removal after stopping the vacuum properly considered as disclosing a configuration of a cushion for breast insertion before application of underpressure, as in claim 1. The Office Action further asserts that the "folded areas" of the stretching section being in a more compact configuration is shown in Fig. 9 of Farka et al. However, as stated above, the configuration of Fig. 9 only occurs when the breast is being removed from the elastic system 100. See para. [0052] ("FIG. 6 presents a vertical section of an embodiment of a milk elicitation system, in one application of the claimed method, with the elastic system connected to a vacuum supply, at the end of the milk elicitation process when the vacuum is switched off and the elastic system regressively contracts and is removed from the cow teat supporting its return in the physiological condition.) (emphasis added); para. [0055] ("FIG. 9 presents a vertical section of an embodiment of a milk elicitation system, in one application of the claimed method, at the end of the process when it is removed from the breast.") (emphasis added). The depicted configuration in Fig. 9 does not occur initially or for receiving the breast, as discussed above (Remarks/Discussion of Issues, pages 10-11). 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, occurring before application of a second underpressure acting on the cushion for receiving the breast in a second milk elicitation. It is understood that after the cushion is removed in Figure 9, the cushion is able to be reapplied to the breast and receive a second underpressure in a second milk elicitation in the manner of Figures 7-8.
In regards to claim 1, Applicant argued: Further, because Fig. 9 shows the end of the cycle, when the vacuum is no longer applied and the breast is being removed, there is no disclosure of "folded areas" that are configured to deform from a more compact configuration in the initial configuration of the cushion to a more straightened configuration in the final configuration of the cushion in response to the underpressure. In Fig. 9, the elastic system is no longer attached to the breast, so underpressure cannot possibly be applied subsequently in order to deform form a more compact configuration to a more straightened configuration. The process would have to start over, i.e., at Fig. 7, which does not show a more compact configuration (Remarks/Discussion of Issues, page 11). Examiner disagrees. Farka et al teaches wherein the one or more folded areas (labeled in Figures 6 and 9 above) of the stretching section (120) are configured to deform from a more compact configuration in the initial configuration of the cushion (100) (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). Farka et al teaches a more compact configuration of the cushion (100) in Figure 9 that is structurally capable of being the initial configuration, occurring before application of a second underpressure acting on the cushion for receiving the breast in a second milk elicitation. It is understood that after the cushion is removed in Figure 9, the cushion is able to be reapplied to the breast and receive a second underpressure in a second milk elicitation in the manner of Figures 7-8 to result in a more straightened configuration of the cushion (Figure 8).
In regards to claim 1, Applicant argued: In rejecting claim 1, the Office Action further asserts in relevant part that "[lower end area] 131 is structurally capable of performing the intended use of maintaining sliding contact with the surface of the air passage element." See Office Action, p. 4 (citing Figs. 8 and 9). 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 clearly shown not in contact with the vacuum supply 200 (apparently the "air passage element"), and does not show how the lower end area 131 could be capable of being in contact the vacuum supply 200 (or why this would be desirable). The written description appears to require use of an "extension" of some sort for the lower end area 131 to be able to 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). Therefore, at most, Farka et al. may arguably disclose that the lower end area 131 contacts the vacuum supply 200 indirectly if some kind of extension is involved. Such an extension would not be in direct contact and would not be slidable along the surface of the vacuum supply 200 since it would be fixed at least on one area, as recited in claim 1. Further, the contacting surface being configured to maintain direct sliding contact with the surface of the air passage element while the cushion deforms and/or moves from the initial configuration to the final configuration is not "intended use," as asserted by the Office Action. Rather, at most, this feature arguably may be considered a "functional limitation," and therefore must be considered in determining patentability. As stated in the MPEP, "'[a] claim limitation is functional when it recites a feature by what it does rather than by what it is' (e.g., as evidenced by its specific structure or specific ingredients)." See MPEP § 2173.05(g) (citing In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226 (CCPA, 1971). "There is nothing inherently wrong with defining some part of an invention in functional terms. Functional language does not, in and of itself, render a claim improper." Id. Accordingly, an applicant is free to recite features of an apparatus either structurally or functionally. See In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). Moreover, functional limitations are to be considered in determining patentability: A functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used. A functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step. See MPEP § 2173.05(g) (emphasis added). Accordingly, as applied to claim 1, the functionality (not "intended use," as asserted by the Office Acton) of the contacting surface must be evaluated and considered by the Office Action. By doing so, it is apparent that Farka et al. fails to disclose the same, as discussed above (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 disclose an air passage element of a breast pump device, and the contacting surface is configured to maintain direct sliding contact with the surface of the air passage element while the cushion deforms and/or moves from the initial configuration to the final configuration, as claimed, in order to anticipate the claim. The contacting surface (131) of Farka is structurally capable of performing maintaining direct sliding contact with the surface of the air passage element while the cushion deforms and/or moves from the initial configuration to the final configuration.
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, page 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 is configured to maintain direct sliding contact with the surface of the air passage element while the cushion deforms and/or moves from the initial configuration to the final configuration, as claimed, in order to anticipate the claim. The air passage element (210) of Farka et al is structurally capable of accommodating performance of the contacting surface maintaining direct sliding contact with the surface of the air passage element while the cushion deforms and/or moves from the initial configuration to the final configuration.
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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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