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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/25/26 has been entered.
Response to Amendment
The amendment filed 02/25/26 has been entered. Claim 1 has been amended. Claims 4, 6-9, 11, and 14-15 are in the original/ previously presented form. Claims 5, 12-13 remain withdrawn. Claims 2-3 and 10 are cancelled. Thus, claims 1, 4, 6-9, 11, and 14-15 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed 10/30/25.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pollen et al. (U.S. PGPUB No. 2015/0217033), hereinafter Pollen.
Regarding claim 1, Pollen discloses a reusable container assembly for a breast pump system (see FIG. 36 and [0073-0074]: FIG. 36 shares several structures of other embodiments, just with additional features such as enhanced valve design 28d. Therefore, other figures and paragraphs will be referenced that describe same structural elements of FIG. 36), comprising:
a first part (22);
a second part (24’) sized and shaped to seal with (as seen in FIG. 36 and [0042]: no milk leaks from device even if device is tipped over and therefore the parts must be sealed) the first part (22), the second part (24’) including a second part breast facing outer surface (outer rim of 24’, see [0044] and ‘Modified FIG. 27’ below);
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and
a funnel (32, see FIG. 3) sized and shaped to receive a breast (34, see FIG. 3 and [0043]), the funnel (32) including a nipple receiving portion (26) mating with the first (22) and second parts (24’) to complete a sealed reusable container assembly (see [0042-0044]) that stores milk (14), the funnel (32) including a funnel breast facing outer surface (30, see [0043]);
wherein the nipple receiving portion (26, see ‘Modified FIG. 5’ below)
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includes an outer surface (see ‘Modified FIG. 5’ above) and the first part (22) includes a first opening (56) and the second part (24’) includes a second opening (see ‘Modified FIG. 5’ above), wherein the outer surface (see ‘Modified FIG. 5’ above) engages and mates with and seals against (as seen in FIG. 4 and described in [0043-0044] & [0046-0047]) each of the first (56) and second openings (see ‘Modified FIG. 5’ above, second opening circumferentially surrounds nipple receiving portion as disclosed by Applicant in FIG. 24C and [0107] and thus must mate and seal the same way as disclosed by Applicant), and wherein milk (14) is stored within (see [0044]: milk storage chamber 42—not labeled in FIG. 36—between outer shell 24 and breast receiver 22. See milk chamber 42 labeled in FIG 4 for visual reference. See [0073-0074] FIG. 36 same as other embodiments with enhanced valve design 28d, instead of 28 as shown in FIG. 4 and described in [0044]) the first part (22) and the second part (24’) and the second part breast facing outer surface (outer rim surface of 24’, see ‘Modified FIG. 36’ below or ‘Modified FIG. 27’ above)
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and the funnel breast facing outer surface (30, see ‘Modified FIG. 36’ above) cooperate to form a contiguous breast facing outer surface (see “cooperation” surfaces shown by the outlines in black in ‘Modified FIG. 36’ above. Surfaces are “contiguous” by intersection) of the breast pump system (see ‘Modified FIG.36’ above).
Regarding claim 4, Pollen discloses the reusable container of claim 1, and Pollen further discloses wherein the container assembly (see FIG. 36) is longitudinally split (see exploded view in at least FIG. 5 showing longitudinal splitting of first and second parts) to define the first (22) and second (24’) parts.
Regarding claim 6, Pollen discloses the reusable container of claim 1, and Pollen further discloses wherein the second part (24’, see FIG. 35) includes an oval opening (formed through the second part breast facing outer surface, see ‘Modified FIG. 36’ above) and the funnel (32) includes an oval shaped base (40) that mates with the oval opening (see [0044]: 24 connects to flange 40 such as shown by arrows in FIG. 5).
Regarding claim 7, Pollen discloses the reusable container of claim 1, and Pollen discloses further comprising a removable plug (28d, see [0073]:28d is removable to form a ‘cleaning’ state of the device) that defines a connection (190, see [0073]) to a conduit (146d) that delivers fluid to the container assembly (see [0044]: milk flows from first part 22 into chamber 46 formed by valve 28 and then into collection chamber 42. Therefore, milk must also flow through/ be delivered by connection 190 and conduit 146d in order to reach the chamber formed within valve 28.)
Regarding claim 8, Pollen discloses the reusable container of claim 1, and Pollen further discloses wherein the first (22, see FIG. 36) and second parts (24’) are welded together (see [0067]: 22 is coupled to 24 and [0075]: “coupled to” includes welded connections).
Regarding claim 9, Pollen discloses the reusable container of claim 1, and Pollen further discloses wherein the first (22, see FIG. 36) and second parts (24’) are removably sealed to each other (see [0043-0044]: removably connected by flange 40).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silver et al. (U.S. PGPUB No. 2010/0121267), hereinafter Silver.
Regarding claim 1, Silver discloses a reusable container assembly for a breast pump system (see [0003]), comprising:
a first part (1350, see FIG. 37);
a second part (1386) sized and shaped to seal with (see [0224]) the first part (1350), the second part (1386) including a second part breast facing outer surface (see ‘Modified FIG. 37’ below); and
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a funnel (1366) sized and shaped to receive a breast (see [0007]: inner shield receives breast and see [0222-0223]: 1366 is inner shield in embodiment of FIG.37), the funnel (1366) including a nipple receiving portion (1368) mating with the first (1350, see [0221-0224]) and second parts (1386, this structure aligns with disclosure of current Application in at least FIG. 24C and [0107] and therefore meets the limitation) to complete a sealed reusable container assembly that stores milk (see [0015], [0028], [0221], and [0225]), the funnel (1366) including a funnel breast facing outer surface (see ‘Modified FIG. 37’ above);
wherein the nipple receiving portion (1368) includes an outer surface (1370) and the first part (1350) includes a first opening (internal opening formed by sidewall within 1358, see [0223]) and the second part (1386) includes a second opening (see ‘Modified FIG. 37’ above), wherein the outer surface (1370, see [0223]) of the nipple receiving portion (1368) engages and mates with and seals against each of the first (inner sidewall of 1358, see [0223]: 1368 inserted into 1350 within inner sidewall 1358) and second openings (see [0223]: 1370 extends to form 1368 & [0224]: 1386 received in channel of 1370 and thus outer surface 1370 mates/seals against second part 1386. Further, this structure aligns with disclosure of current Application in at least FIG. 24C and [0107] and therefore meets the limitation), and wherein milk is stored within the first part and the second part (see [0225]: milk flows through first and second parts and stores milk that is prevented from spilling) and the second part breast facing outer surface (see ‘Modified FIG. 37’ above) and the funnel breast facing outer surface (see ‘Modified FIG. 37’ above) cooperate to form a contiguous breast facing outer surface of the breast pump system (see [0224]: 1382 snap fit into 1362 and thus forms contiguous surface and this structure aligns with current invention disclosure in FIG. 24C and [0107]).
Claim Rejections - 35 USC § 103
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 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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Pollen as applied to claim 1 above, and further in view of Garbez et al. (U.S. PGPUB No. 2018/0008758), hereinafter Garbez.
Regarding claim 11, Pollen discloses the reusable container of claim 1, but Pollen is silent to wherein the second part “includes a scalloped edge that is sized and shaped to mate with a second scalloped edge of the first part.”
However, Garbez teaches a reusable container assembly for a breast pump system (see FIG. 5) comprising a first part (32) and a second part (20), wherein the second part (20) includes a scalloped edge (38, see [0026]) that is sized and shaped to mate with (see [0026]: edges engaged to form snap-fit connection) a second scalloped edge (34) of the first part (32).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second part edges disclosed in Pollen to include scalloped edges as taught by Garbez for the purpose of forming a snap-fit engagement at the outer rims of the first and second part (see [0026]), thus achieving wherein the second part “includes a scalloped edge that is sized and shaped to mate with a second scalloped edge of the first part.”
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pollen as applied to claim 1 above, and further in view of Quay (U.S. PGPUB No. 2002/0072702).
Regarding claim 14, the modified system of Myers teaches the reusable container of claim 1, but Myers is silent to “further comprising a locking ring sized and shaped to be rotated about the nipple receiving portion.”
However, Quay teaches a breast pump assembly for withdrawing fluid from a breast (see [0020]) including a locking ring (109, see FIG. 11) sized and shaped to be rotated (see [0136]: 109 is rotatable received onto 22 by, in example, see [0135] threadable engagement) about a nipple receiving portion (22 wherein nipple 16 is received).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nipple receiving portion disclosed in Pollen to include the rotatable locking ring as taught in Quay for the purpose of obtaining a removable connection between components or to adjustably mount the device to ensure contact with the breast fluid (see [0136]), thus achieving “further comprising a locking ring sized and shaped to be rotated about the nipple receiving portion.”
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pollen as applied to claim 1 above, and further in view of Vogelin et al. (U.S. PGPUB No. 2007/0179439), hereinafter Vogelin.
Regarding claim 15, Pollen discloses the reusable container of claim 1, and Pollen discloses further comprising a fitment assembly (28d, see FIG. 36) including one or more components (see [0073-0074]: 28d/ 148d of valve attached to assembly 146d), but is silent to the one or more components “formed from layers of TPE/LDPE/TPE or similar variations so that the TPE parts are utilized as sealing material with mating parts.”
However, Vogelin teaches a breast pump assembly with a container (see Fig. 2) wherein at least one part, particularly a valve body (7), is formed of TPE (see [0062]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve of the fitment assembly as disclosed by Pollen to be made from TPE as taught by Vogelin for the purpose of reducing the repeated use duration by choosing a non-autoclavable material ([0062]: TPE is a non-autoclavable material and [0023-0024]), thus configuring the breast shield set of the device for repeated use of only a few times (see [0004]: breast shield set should only be used repeatedly a few times for hygiene reasons and to drive down the manufacturing cost of some of the assembly components), thus achieving the fitment assembly including one or more components “formed from layers of TPE/LDPE/TPE or similar variations so that the TPE parts are utilized as sealing material with mating parts.”
Response to Arguments
Applicant's arguments filed 02/25/26 have been fully considered but they are not persuasive.
On page 5 of Applicant remarks, Applicant argues that Pollen does not disclose the outer surface of the nipple receiving portion that “engage, mate with, and seal against” the second opening of the second part because the surfaces do not touch. However, the examiner disagrees in view of the current Application’s disclosure and maintains the 35 U.S.C § 102 claim rejections under Pollen.
Applicant has elected the embodiment of FIG. 24C (a modified figure is provided below), see “Response to Restriction requirement” dated 03/11/24. In the elected embodiment, Applicant shows the second opening of the second part merely circumferentially extending around the outer surface of the nipple receiving portion (See figure ‘Elected embodiment FIG. 24C’ below and [0107] of Applicant disclosure).
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Because Applicant does not disclose further how such engaging/mating/sealing is achieved, the examiner maintains that prior art, such as Pollen, that discloses the same structure will also function the same way as disclosed by Applicant (i.e.: any second part opening circumferentially surrounding the outer surface of the nipple receiving portion MUST also engage/mate/seal in the same manner as claimed and described in Applicant in at least FIG. 24C and [0107]). Therefore, the examiner has maintained the 35 U.S.C. § 102 claim rejections under Pollen.
Because no further arguments were presented, all subsequent depending claim rejections were also maintained by the examiner.
However, in the interest of expediting prosecution, the examiner has provided a supplementary 35 U.S.C. § 102 claim rejection of claim 1 under Silver and has also provided additional prior art references in the conclusion section below. Applicant is encouraged to further amend the claim language to recite structure that distinguishes the current invention from all cited prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
O’Toole et al. (U.S. PGPUB No. 2018/0361040) teaches the claimed elements of at least claim 1 as shown in the modified figure below. see also FIGURE 4
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Bjorge (U.S. Patent No. 7,811,248) teaches the claimed elements of at least claim 1 such as shown in ‘Modified FIG. 3’ below
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783