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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 3/23/2026 is acknowledged.
Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/23/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/14/2023 and 3/24/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
Figure 1 and 2 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “item 150” has been used to designate both internal ribs in figure 9 and a lip in figure 15. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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 abstract of the disclosure is objected to because:
Line 7 recites “the container”. Line 5 recites “a milk container”. Examiner suggests replacing “the container” in line 7 with “the milk container” to put the abstract in clearer form and clearly refer to the milk container of line 5.
Line 8 recites “the opening”. The abstract introduces a first part of a container opening, a second part of the container opening, and a large lid opening. It is unclear which opening the opening of line 8 is referring to. Examiner suggests replacing “the opening” with “the second part of the opening” or the respective opening “the opening” refers to.
Line 8 recites “the opening”. The abstract introduces a first part of a container opening, a second part of the container opening, and a large lid opening. It is unclear which opening the opening of line 8 is referring to. Examiner suggests replacing “the opening” with “the second part of the opening” or the respective opening “the opening” refers to.
Line 9 recites “a valve”. As the valve has already been introduced in line 3 of the abstract, Examiner suggests replacing “a valve” with “the valve” to put the abstract in clearer form.
Line 9 recites “another part of the opening”. The abstract introduces a first part of a container opening, a second part of the container opening, and a large lid opening. It is unclear which opening the opening of line 9 is referring to. Examiner suggests replacing “another part of the opening” with “the first part of the opening” or the respective opening “another part of the opening” refers to.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 objected to because of the following informalities:
Line 1-2 recites “A diaphragm for a breast pump, formed of a flexible membrane, comprising:”. Examiner suggests replacing “A diaphragm for a breast pump, formed of a flexible membrane, comprising:” in line 1-2 of claim 1 with “A diaphragm for a breast pump, formed of a flexible membrane, the diaphragm comprising:” to put the claim in clearer form that the additional components listed in claim 1 are of the diaphragm and not the breast pump.
Claim 6 objected to because of the following informalities:
Line 2 recites “the center of the cavity”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the center of the cavity” in line 2 of claim 6 with “a center of the cavity”.
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 1-9 are 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.
In regard to claim 1,
Line 4 recites “and being arranged to deform when a vacuum or an overpressure is applied”. It is unclear if the cavity or the closed end is arranged to deform when a vacuum or an overpressure is applied. For examination purposes Examiner construes either the cavity or the closed end to be arranged to deform when a vacuum or an overpressure is applied. Examiner suggests clarifying what structure is arranged to deform when a vacuum or an overpressure is applied.
Line 5-6 recites “for controlling a flow path to a milk container through a first part of a container opening”. It is unclear if the valve or the valve closure element is for controlling a flow path to a milk container through a first part of a container opening. For examination purposes Examiner construes the valve to be for controlling a flow path to a milk container through a first part of a container opening. Examiner suggests replacing “a valve closure element for forming part of a valve for controlling a flow path to a milk container” in line 5-6 of claim 1 with “a valve closure element for forming part of a valve, the valve for controlling a flow path to a milk container”
Line 6 recites “a first part of a container opening”. Line 5-6 recites “a milk container”. It is unclear if the container opening is of the milk container or of a second container. It is therefore unclear is a milk container and an additional container with a container opening is required. For examination purposes Examiner construes the container opening to be of the milk container. Examiner suggests replacing “a first part of a container opening” in line 6 of claim 1 with “a first part of a container opening of the milk container”.
Examiner notes claims 2-9 are similarly rejected by virtue of their dependency on claim 1.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Renz (U.S. PG publication 20050154349).
In regard to claim 1,
Renz discloses a diaphragm (figure 14, item 3600) for a breast pump (figure 13, item 3200; Examiner notes “for a breast pump” is a functional limitation and the breast pump is not positively required by the claim), formed of a flexible membrane (paragraph [0109]), comprising:
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a cavity (see cavity formed by item 3600 which is the opening that extends through item 3600 in figure 13 and 14 and forms an upper insert volume 3615 and a lower insert volume 3650) for receiving a nipple of a user (paragraph [0110]), said cavity having an open end (see figure 14 above: end which breast is received through; paragraph [0110]; see figure 13 and 14) and a closed end (see figure 14 above: end of cavity closed by valve 3683 which is closed as shown in figure 13 and 14) and being arranged to deform when a vacuum or an overpressure is applied (paragraph [0112]; Examiner notes “arranged to deform when a vacuum or an overpressure is applied” is a functional limitation. Due to the material/structure of the diaphragm which forms the cavity, the cavity is fully capable of the recited function);
a valve closure element (see figure 14 above) for forming part of a valve (see figure 14 above) for controlling a flow path to a milk container (figure 14, item 3900; Examiner notes “for controlling a flow path to a milk container” is a functional limitation and the milk container is not positively required by the claim) through a first part of a container opening (see opening of item 3900 which item 3683 extends through as shown in figure 13; paragraph [0112]); and
a lid (figure 14, item 3681) for closing a second part of the container opening (see figure 13 wherein item 3681 closes a second part of the container opening as shown in figure 13).
In regard to claim 2,
Renz discloses the diaphragm of claim 1, wherein the valve closure element extends from a bottom edge of the open end (see figure 14 above).
In regard to claim 3,
Renz discloses the diaphragm of claim 1, wherein the valve closure element is hinged at an edge where the valve closure element connects to the lid (see figure 14 above; paragraph [0112]; Examiner notes the valve is a duckbill valve and the valve closure element is hinged at an edge where the valve closure element connects to the lid to enable the duckbill valve to open and close).
In regard to claim 4,
Renz discloses the diaphragm of claim 1, further comprising a positioning tab (figure 13, item 3625) extending from a top edge of the open end (see figure 13).
In regard to claim 5,
Renz discloses the diaphragm of claim 1, further comprising a connecting portion (figure 13, item 3625) for connecting the diaphragm to a breast shield and/or a vacuum cover of the breast pump (see figure 13; Examiner notes “for connecting the diaphragm to a breast shield and/or a vacuum cover of the breast pump” is a functional limitation. The connecting portion is fully capable of the recited function due to its structure. The breast shield and/or a vacuum cover of the breast pump are not positively required by the claim. The connecting portion could be connected to an appropriately sized breast shield for example).
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 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Renz (U.S. PG publication 20050154349) further in view of Silver (U.S. PG publication 20110071466).
In regard to claim 6,
Examiner notes an alternative interpretation of Renz in regard to the closed end is being used to reject claim 1 for the rejection of claim 6.
In regard to claim 1,
Renz discloses a diaphragm (figure 14, item 3600) for a breast pump (figure 13, item 3200; Examiner notes “for a breast pump” is a functional limitation and the breast pump is not positively required by the claim), formed of a flexible membrane (paragraph [0109]), comprising:
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a cavity (see cavity formed by item 3600 which is the opening that extends through item 3600 in figure 13 and 14 and forms an upper insert volume 3615 and a lower insert volume 3650) for receiving a nipple of a user (paragraph [0110]), said cavity having an open end (see figure 14 above: end which breast is received through; paragraph [0110]; see figure 13 and 14) and a closed end (see figure 14 above) and being arranged to deform when a vacuum or an overpressure is applied (paragraph [0112]; Examiner notes “arranged to deform when a vacuum or an overpressure is applied” is a functional limitation. Due to the material/structure of the diaphragm which forms the cavity, the cavity is fully capable of the recited function);
a valve closure element (see figure 14 above) for forming part of a valve (see figure 14 above) for controlling a flow path to a milk container (figure 14, item 3900; Examiner notes “for controlling a flow path to a milk container” is a functional limitation and the milk container is not positively required by the claim) through a first part of a container opening (see opening of item 3900 which item 3683 extends through as shown in figure 13; paragraph [0112]); and
a lid (figure 14, item 3681) for closing a second part of the container opening (see figure 13 wherein item 3681 closes a second part of the container opening as shown in figure 13).
In regard to claim 6,
Renz discloses diaphragm of claim 1 (see alternative rejection of claim 1 above).
Renz is silent as to wherein the cavity comprises a ridge which extends from a base of the cavity towards the center of the cavity.
Silver teaches wherein the cavity (figure 11A, item 92) comprises a ridge (figure 11A, item 95’; see figure 11A where item 95’ is attached to item 91’ and a valve 94 is included) which extends from a base of the cavity towards the center of the cavity (see figure 11A).
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 cavity of Renz to include a ridge which extends from a base of the cavity towards the center of the cavity and to also incorporate a dividing wall 91’ and valve 94 into the cavity directly next to the closed end of Renz, as taught by Silver, for the purpose of being reminiscent of a tongue of a baby to better express milk (paragraph [0020] and [0085]-[0087] of Silver).
In regard to claim 7,
Renz in view of Silver teaches the diaphragm of claim 6, comprising a first side flow path to a first side of the ridge (see figure 11A of Silver) and a second side flow path to an opposite second side of the ridge (see figure 11A of Silver).
In regard to claim 8,
Renz in view of Silver teaches the diaphragm of claim 6, wherein the ridge extends from the open end to the closed end (see figure 11A of Silver and analysis of claim 6 above wherein when the ridge is incorporated into Renz, it would extend from the open end to the closed end of figure 14 of Renz labeled above in the alternative rejection of claim 1).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Renz (U.S. PG publication 20050154349) further in view of Alvarez (U.S. PG publication 20180078687).
In regard to claim 9,
Renz discloses the diaphragm of claim 1.
Renz is silent as to wherein the flexible membrane has a non-uniform thickness with locally thinner regions to define hinge points.
Alvarez teaches wherein the flexible membrane (figure 3b, item 305) has a non-uniform thickness (see figure 3B; paragraph [0040]) with locally thinner regions (item 354) to define hinge points (paragraph [0044]).
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 Renz to include wherein the flexible membrane has a non-uniform thickness with locally thinner regions to define hinge points, as taught by Alvarez, for the purpose of improving the efficiency of milk expression (paragraph [0006], [0040], and [0044] of Alvarez).
Conclusion
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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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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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783