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 08/24/2026 has been entered. Claims 1-5 & 7-16 are pending in the application. Claims 13-15 are withdrawn. Claim 6 is cancelled. Claim 16 is entered as “New”.
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 11 & 16 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.
As to Claim 11, the term “a reduced pressure between 2kPa and 10kPa” is indefinite.
A space should be placed between each of the values and the units in the limitation.
Claim 1 defines a reduced pressure. As such, it is not clear if the reduced pressure of Claim 1 and the reduced pressure of Claim 11 are the same pressures, or if the two pressures are different. If the two pressures are different, it is not clear what differentiates the two pressures. If the two pressures are the same, it is not clear why a new term is being used in place of the defined reduced pressure of Claim 1. For the purpose of examination, the two pressures will be interpreted as the same pressure.
Additionally, it is not clear if the claimed pressure range is a measured pressure or a pressure which is 2 kPa to10 kPa below a baseline pressure, rendering the claim indefinite.
As to Claim 16, the limitation “10kPa”, is indefinite. The limitation is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: what the term “10 kPa” is related to. For the purpose of examination, the limitation will be interpreted as a typo, where Applicant did not intend to include that portion of the claim when copying and pasting from Claim 11.
Additionally, the term “10kPa” should read –10k Pa.
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.
Claims 1-5, 7-9, 11-12 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dao (U.S. PGPub 2008/0262420), in view of O’Toole (U.S. PGPub 2022/0395616).
As to Claim 1, Dao teaches a breast pump (10), comprising:
a breast shield (16) for fitting over (as shown in Figure 2) at least the nipple (34) of a breast (14) thereby to create (as shown in Figure 6) a cavity (24) over (as shown in Figure 6) the breast (14);
a pump (12) for delivering an under pressure to (Paragraph 0074) the cavity (24, shown as 70 in Figures 11A-11C, as described in Paragraph 0074); and
a compressible (Paragraph 0061 describes chamber 18 as being flexible, which one of ordinary skill in the art would interpret as being “compressible”) chamber (18).
Dao does not teach the compressible chamber is capable of manually creating a reduced pressure in the cavity.
O’Toole describes a breast pump, and teaches the compressible (Paragraph 0047) chamber (10) is capable of manually (via compressing milk pouch 10 –i.e., the compressible chamber—by the user, as described in Paragraph 0010) creating a reduced pressure (the “suction on the nipple” or “negative pressure”, as described in Paragraph 0010; the “negative pressure” in Paragraph 0055) in the cavity (20).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to replace the compressible chamber, as taught by Dao, with the compressible chamber, as taught by O’Toole, to allow for passive milk collection, while preventing the pump from “falling from the user and causing mess and/or milk wastage (Paragraphs 0008/0007)”.
As to Claim 2, Dao, as modified, teaches all the limitations of Claim 1, and continues to teach the pump (Dao 12) is an electric pump (Dao Paragraph 0065).
As to Claim 3, Dao, as modified, teaches all the limitations of Claim 1, and continues to teach the compressible chamber (O’Toole 10) is elastic (O’Toole describes the milk pouch 10 as being compressible, which one of ordinary skill in the art would interpret as being “elastic”; as shown in O’Toole Figure 12) and delivers a restoring force to return to a non-compressed state (the expansion as described in O’Toole Paragraph 0069).
As to Claim 4, Dao, as modified, teaches all the limitations of Claim 1, and continues to teach the compressible chamber (O’Toole 10) comprises a milk collection container (O’Toole Paragraph 0047).
As to Claim 5, Dao, as modified, teaches all the limitations of Claims 1 & 4, and continues to teach the milk collection container (O’Toole 10) has a volume greater than 120 ml (O’Toole Paragraph 0045, where 5 fluid oz is approximately 147 ml).
As to Claim 7, Dao, as modified, teaches all the limitations of Claims 1 & 4, and continues to teach a first, one-way, valve (Dao 74/80) between (as shown in Dao Figure 11A) the breast shield (Dao 16) and the milk collection container (O’Toole 10, shown as Dao 18 in Dao Figure 11A).
As to Claim 8, Dao, as modified, teaches all the limitations of Claims 1, 4 & 7, and continues to teach the first valve (Dao 74/80) is a duckbill valve (Dao Paragraph 0074).
As to Claim 9, Dao, as modified, teaches all the limitations of Claims 1, 4 & 7, and continues to teach a second, one-way, valve (O’Toole 12) from (as shown in O’Toole Figure 1) the compressible chamber (O’Toole 10) to (as shown in O’Toole Figure 1) ambient surroundings (the volume outside of O’Toole 10, as shown in O’Toole Figure 1).
As to Claim 11, Dao, as modified, teaches all the limitations of Claim 1, but is silent on the values of the reduced pressure generated by the compressible chamber, so does not explicitly teach the compressible chamber generates a reduced pressure between 2kPa and 10kPa.
O’Toole Paragraph 0055 defines the negative pressure value as a result-effective variable (see MPEP 2144.05(II)(B)), where the negative pressure value affects the comfort of the user or the efficiency of the pump.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the compressible chamber, as taught by Dao, as modified, generate a negative pressure between 2 kPa and 10 kPa, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (1955)
As to Claim 12, Dao, as modified, teaches all the limitations of Claim 1, and continues to teach the breast pump (Dao 10, as modified) is a wearable breast pump (as shown in Dao Figures 1-2 and O’Toole Paragraph 0010).
As to Claim 16, Dao, as modified, teaches all the limitations of Claims 1 & 11, and continues to teach 10kPa and/or wherein the compressible chamber (O’Toole 10) is formed of a silicone (O’Toole Paragraphs 0118/0141).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Dao, in view of O’Toole, further in view of Aalders (U.S. PGPub 2020/0061263).
As to Claim 10, Dao, as modified, teaches all the limitations of Claim 1, but does not teach the breast shield comprises a diaphragm between the cavity and the pump.
Aalders describes a breast pump, and teaches the breast shield (20/23) comprises (as shown in Figure 1) a diaphragm (27; the membrane described in Paragraph 0034) between (as shown in Figure 1) the cavity (22) and the pump (3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use a diaphragm, as taught by Aalders, in the breast shield, as taught by Dao, as modified, to prevent milk from leaking into the connection between the breast shield and the pump (Paragraph 0034).
Response to Arguments
Applicant's arguments filed 08/24/2026 have been fully considered but they are not persuasive.
Regarding the drawing objections. The drawing objections are withdrawn due to the cancellation of Claim 6. However, Applicant should note the claimed structure is included in withdrawn Claim 14. Should the withdrawn claims be rejoined due to allowance, Applicant will also be required to either cancel Claim 14 or provide new drawings showing the claimed structure.
Regarding the 112(b) rejections, Applicant overcame the previous rejections. However, new rejections due to the amendments to the claims are presented above.
Regarding the 103 rejection for Claim 1, Applicant argues the combination of O’Toole with Dao is improper, since “O'Toole's compressible pouch is a passive breast-facing milk collection device that itself creates suction when squeezed, not a compressible chamber in a pump-driven breast pump that manually creates reduced pressure in the same cavity to which the pump delivers under pressure.” Examiner is confused by this statement.
The disputed limitation requires “the compressible chamber is capable of manually creating a reduced pressure in the cavity.” When referencing Applicant’s statement describing what O’Toole’s compressible pouch is –i.e., “O'Toole's compressible pouch is a passive breast-facing milk collection device that itself creates suction when squeezed”— it appears Applicant is merely rephrasing the disputed limitation.
For example, Applicant admits the O’Toole compressible chamber may be squeezed, which one of ordinary skill in the art would conclude makes the O’Toole compressible chamber “compressible”. This same statement would also lead one of ordinary skill in the art to determine the compressible chamber is capable of manually creating a reduced pressure, since the O’Toole chamber is “squeezed”. Similarly, one of ordinary skill in the art would conclude the term “suction” is a synonym for “reduced pressure”.
If Applicant is alluding to O’Toole not having a second pump, so is not analogous art, this argument also is not persuasive. There is nothing in O’Toole which would prevent one of ordinary skill in the art from using the O’Toole compressible chamber as a replacement for the Dao compressible chamber. Additionally, once the O’Toole compressible chamber is modified into the Dao breast pump, the O’Toole compressible chamber operated exactly how O’Toole intended. As such, the combination of Dao, as modified by O’Toole, is proper and teaches each of the claimed limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
