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 6/2/2026 has been entered. Claims 1-15 are pending in the application. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 3/2/2026.
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 1-6 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alvarez et al. (US 2017/0136161 A1, hereinafter referred to as “Alvarez ‘161”).
Regarding claim 1, Alvarez '161 discloses a diaphragm (expandable membrane 1300, see Figs. 13A-C) for a breast pump (see par. [0088]), the diaphragm (expandable membrane 1300) formed of a flexible membrane (see par. [0087]-[0088]), and comprising:
a cavity (cavity of expandable membrane 1300, see Figs. 13A-C) having an open end (end of cavity of expandable membrane 1300 at flange 1360) for receiving a nipple of a user and a closed end (end of cavity of expandable membrane 1300 at apex 1310) (see Figs. 13A-C, par. [0087]-[0088]), wherein the cavity (cavity of expandable membrane 1300) comprises a ridge (one of valleys 1315) which extends from a base of the cavity (cavity of expandable membrane 1300) towards a center of the cavity (cavity of expandable membrane 1300) (see Figs. 13A-C, par. [0087]-[0088]);
a first side flow path to a first side of the ridge (one of valleys 1315) sloping downwardly in use from the closed end (end of cavity of expandable membrane 1300 at apex 1310) to the open end (end of cavity of expandable membrane 1300 at flange 1360) (see Figs. 13A-C, par. [0087]-[0088], see first annotated Fig. 13A below, pleats 1305 form flow paths on opposite sides of valleys 1315 which at least partially slope downward); and
a second side flow path to an opposite second side of the ridge (one of valleys 1315) extending downwardly in use from the closed end (end of cavity of expandable membrane 1300 at apex 1310) to the open end (end of cavity of expandable membrane 1300 at flange 1360) (see Figs. 13A-C, par. [0087]-[0088], see first annotated Fig. 13A below, pleats 1305 form flow paths on opposite sides of valleys 1315 which at least partially slope downward).
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First annotated Fig. 13A
Regarding claim 2, Alvarez '161 discloses the diaphragm of claim 1, further comprising a connecting portion (portion of expandable membrane 1300 directly connected between flange 1360 and housing 1355, see Fig. 13C, par. [0088]) for connecting the diaphragm (expandable membrane 1300) to a breast shield (flange 1360) and/or a vacuum cover (housing 1355) of the breast pump (see Figs. 13C, par. [0087]-[0088]).
Regarding claim 3, Alvarez '161 discloses the diaphragm of claim 1, comprising a milk flow passage (drain port 1320) at a bottom part of the open end (end of cavity of expandable membrane 1300 at flange 1360) of the cavity (cavity of expandable membrane 1300) and a connector (top portion of expandable membrane 1300 directly connected to flange 1360) at a top part of the open end (end of cavity of expandable membrane 1300 at flange 1360) for connecting to a breast shield (flange 1360) (see Figs. 13A-C, par. [0087]-[0088]).
Regarding claim 4, Alvarez '161 discloses the diaphragm of claim 1, wherein the ridge (one of valleys 1315) extends from the open end (end of cavity of expandable membrane 1300 at flange 1360) to the closed end (end of cavity of expandable membrane 1300 at apex 1310) (see Figs. 13A-C, par. [0087]-[0088], see first annotated Fig. 13A above).
Regarding claim 5, Alvarez '161 discloses the diaphragm of claim 1, further comprising a second ridge (another of valleys 1315) which extends from a first side of the cavity towards the center of the cavity (cavity of expandable membrane 1300), and a third ridge (a third of valleys 1315) which extends from a second side of the cavity (cavity of expandable membrane 1300) towards the center of the cavity (see Figs. 13A- C, par. [0087]-[0088], see second annotated Fig. 13A below).
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Second annotated Fig. 13A
Regarding claim 6, Alvarez '161 discloses the diaphragm of claim 1, wherein a shape formed by a closed path around the open end (end of cavity of expandable membrane 1300 at flange 1360) of the cavity (cavity of expandable membrane 1300) is non-rotationally symmetric, with a greater radius of curvature at a bottom than at a top (see Figs. 13A-C, expandable membrane 1300 is slanted as shown in Fig. 13C and the bottom pleat is longest as shown in Fig. 13B such that expandable membrane 1300 is non-rotationally symmetric with a greater radius of curvature at the bottom).
Regarding claim 10, Alvarez '161 discloses a breast pump see Figs. 13A-C, par. [0087]-[0088]) comprising:
the diaphragm (expandable membrane 1300) of claim 1 (see Figs. 13A-C, claim 1 rejection above);
a cover (reservoir 1365) over the diaphragm (expandable membrane 1300) to define a sealed space between the cover (reservoir 1365) and the diaphragm (expandable membrane 1300) (see Figs. 13A-C, par. [0088]);
a breast shield (flange 1360 and housing 1355) to which the cover (reservoir 1365) and the diaphragm (expandable membrane 1300) are coupled (see Figs. 13A-C, par. [0088]);
a pressure source (pump, pump mechanisms, or actuatable mechanisms coupled via outlet 1370 and tube, see par. [0088]) for delivering a variable pressure to the sealed space (see par. [0088]); and
a milk collection container (collection vessel, see par. [0087]).
Regarding claim 11, Alvarez '161 discloses the breast pump of claim 10, wherein the open end (end of cavity of expandable membrane 1300 at flange 1360) of the cavity (cavity of expandable membrane 1300) has a top part and a bottom part which connect to the breast shield (flange 1360 and housing 1355) (see Fig. 13C), wherein the top part is set further back from the closed end (end of cavity of expandable membrane 1300 at apex 1310) in a direction parallel to a central axis of the diaphragm (expandable membrane 1300) than the bottom part (see Figs. 13A-C).
Regarding claim 12, Alvarez '161 discloses the breast pump of claim 10, wherein an end of the first side flow path at the open end (end of cavity of expandable membrane 1300 at flange 1360) of the cavity (cavity of expandable membrane 1300) and an end of the second side flow path at the open end (end of cavity of expandable membrane 1300 at flange 1360) of the cavity (cavity of expandable membrane 1300) are positioned outside the area of an opening (right opening of flange 1360 in Fig. 13C) in the breast shield (flange 1360 and housing 1355) (see Fig. 13C).
Regarding claim 13, Alvarez '161 discloses the breast pump of claim 10, wherein the diaphragm (expandable membrane 1300) has external ribs (see Fig. 13B, the exterior surfaces of pleats 1305 are external ribs) (see Figs. 13B-C, par. [0087]-[0088]).
Regarding claim 14, Alvarez '161 discloses the breast pump of claim 10, wherein the breast shield (flange 1360 and housing 1355) comprises a valve seat (opening of housing 1355 for receiving drain port 1320) for supporting a valve closure element of the diaphragm (expandable membrane 1300) to form a valve (see Fig. 13C, par. [0087]-[0088], note: "for supporting a valve closure element of the diaphragm to form a valve" is a functional limitation such that a valve closure element and a valve are not required by the claim. Housing 1355 includes an opening which supports a drain port 1320. As shown in Fig. 3B with drain port 265 containing a one-way valve 280, drain port 1320 could similarly have a valve closure element, see par. [0063]-[0064]).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Alvarez et al. (US 2017/0136161 A1, hereinafter referred to as "Alvarez '161"), as applied to claim 1 above, in view of Alvarez et al. (US 2018/0078687 A1, hereinafter referred to as "Alvarez '687").
Regarding claim 7, Alvarez '161 discloses the diaphragm of claim 1. However, Alvarez '161 fails to expressly state wherein the flexible membrane has a non-uniform thickness with locally thinner regions to define hinge points, wherein the flexible membrane has a hinge point at a back of the ridge.
Alvarez '687 teaches a diaphragm (expandable membrane 305) has a non-uniform thickness (see par. [0040]) with locally thinner regions (thinner flanking portions 354) to define hinge points, wherein the flexible membrane has a hinge point at a back of the ridge (see Fig. 3A, par. [0040] and [0044], one of thinner flanking portions is at the back/right end in Figs. 3A-B).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the diaphragm of Alvarez '161 to include wherein the flexible membrane has a non-uniform thickness with locally thinner regions to define hinge points, wherein the flexible membrane has a hinge point at a back of the ridge, as taught by Alvarez '687, in order to aid in the movement of the diaphragm to create negative pressure and enable the movement of the diaphragm to better correspond to the movement of an infant's mouth during nursing (see Alvarez '687 par. [0040] and [0044]).
Claims 8-9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez et al. (US 2017/0136161 A1, hereinafter referred to as "Alvarez '161"), as applied to claims 2 and 10 above.
Regarding claim 8, Alvarez '161 discloses the diaphragm of claim 2 in the embodiment of Figs. 13A-C. However, Alvarez '161, in the embodiment of Figs. 13A-C, fails to expressly state a valve closure element for forming part of a valve, the valve closure element extending from a bottom edge of the open end.
Alvarez '161 teaches another embodiment of a diaphragm (expandable membrane 245a, see Fig. 3B) comprising a valve closure element (one-way valve 280) for forming part of a valve (see par. [0063]-[0064], the valve closure element (one-way valve 280) extending from a bottom edge of the open end (end of cavity of expandable membrane 245a at flange 236) (see Fig. 3B, par. [0063]-[0064]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the diaphragm of the embodiment of Figs. 13A-C of Alvarez '161 to include a valve closure element within the opening of the drain port 1320 to form a part of a valve and extending from a bottom edge of the open end, as taught by the embodiment of Fig. 3B of Alvarez '3B, in order to provide the passage of milk while maintaining vacuum pressure in the cavity (see Alvarez '161 par. [0063]-[0064]).
Regarding claim 9, modified Alvarez '161 teaches the diaphragm of claim 8 substantially as claimed. Modified Alvarez '161 further teaches wherein the valve closure element (one-way valve 280, see previous modifications in rejection of claim 8 above to include the one-way valve 280 of Fig. 3B within the drain port 1320 of Figs. 13A-C) is for controlling a flow path to a milk container (collection vessel, see par. [0087], see first annotated Fig. 3C below) through a first part of a container opening and the diaphragm (expandable membrane 1300) further comprises a lid (outwardly extending ridge of drain port 1320) for sealing a second part of the container opening (see Figs. 13A-C, par. [0087]-[0088], see previous modifications in rejection of claim 8 above, see first annotated Fig. 13C below).
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First annotated Fig. 13C
Regarding claim 15, Alvarez '161 discloses the breast pump of claim 10, wherein the breast shield (flange 1360 and housing 1355) defines a rim (see second annotated Fig. 13C below) for engaging with an opening of the milk collection container (collection vessel, see par. [0087]), with a rim opening (see second annotated Fig. 13C below) formed internally of the rim (see second annotated Fig. 13C below), wherein the diaphragm (expandable membrane 1300) is for passing through the rim opening (see annotated Fig. 13C below) during fitting of the diaphragm (expandable membrane 1300) to the breast shield (flange 1360 and housing 1355) and a lid (see annotated Fig. 13C below) of the diaphragm (expandable membrane 1300) is for closing the rim opening (see annotated Fig. 13C below) after fitting of the diaphragm (expandable membrane 1300) to the breast shield (flange 1360 and housing 1355).
However, Alvarez '161, in the embodiment of Figs. 13A-C, fails to expressly state wherein a valve closure element of the diaphragm is for passing through the rim opening during fitting of the diaphragm to the breast shield.
Alvarez '161 teaches another embodiment of a diaphragm (expandable membrane 245a, see Fig. 3B) of a breast pump (Fig. 3B) comprising a valve closure element (one-way valve 280) within a drain port (drain port 265) of the diaphragm (expandable membrane 245a) (see Fig. 3B, par. [0063]-[0064]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the diaphragm of the breast pump of the embodiment of Figs. 13A-C of Alvarez '161 to include a valve closure element within the drain port 1320, as taught by the embodiment of Fig. 3B of Alvarez '3B, in order to provide the passage of milk while maintaining vacuum pressure in the cavity (see Alvarez '161 par. [0063]-[0064]). With a valve within the drain port 1320 as shown in the second annotated Fig. 3C below, this modification thus further teaches the valve closure element (valve within drain port 1320, see second annotated Fig. 3C below) of the diaphragm (expandable membrane 1300) is for passing through the rim opening (see second annotated Fig. 13C below) during fitting of the diaphragm (expandable membrane 1300) to the breast shield (flange 1360 and housing 1355).
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Second annotated Fig. 13C
Response to Arguments
Applicant's arguments filed 6/2/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Alvarez ‘161’s valleys 1315 are not “a ridge which extends from a base of the cavity towards a center of the cavity” as claimed. This argument is not found to be persuasive. As described in the rejection of claim 1 above, one of the valleys 1315 can be considered a ridge (i.e. a protrusion, bump, raised portion, etc.) which extends from a base of the cavity (cavity of expandable membrane 1300) towards the center of the cavity (cavity of the expandable membrane 1300) (see also Figs. 13A-C, par. [0087]-[0088]). Since the cavity is the chamber/space inside of the expandable membrane 1300, the cavity takes the shape of the pleats 1305 and valleys 1315. The valleys 1315 are shown to protrude inward towards the center such that they can be considered a ridge in the manner recited in the claim.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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