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 .
Claim Objections
Claim 12 is objected to because of the following informalities: “an first housing member” does not make grammatical sense. “a first housing member” is suggested. 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.
Claim(s) 21 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quackenbush et al (US 2008/0255503).
Regarding claim 21, Quackenbush discloses a breast pump valve assembly comprising: a variable volume fluid chamber 130/168 defined between a first one-way valve 172/174 and a second one-way valve (¶53 – valve between 118 and 168 – essentially shown as 270 in fig 6), wherein the first one-way valve is configured to allow flow of fluid into the fluid chamber (¶48) and the second one-way valve is configured to allow flow of fluid out of the fluid chamber (¶53); and a displacement member 116 configured for varying the volume of the fluid chamber, wherein the displacement member is configured such that movement of the displacement member to increase the volume of the fluid chamber thereby draws fluid into the fluid chamber through the first one-way valve (¶44 and ¶46 – transmits vacuum generated by vacuum pump mechanism; one of ordinary skill in the art would appreciate the vacuum is generated by increasing the volume in the fluid chamber (increasing volume to lower pressure/create vacuum).
Regarding claim 25, further comprising an actuator configured to operably move the displacement member to thereby vary the volume of the fluid chamber (handle 117).
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(s) 1-5, 7-20, 22-24 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quackenbush et al (US 2008/0255503) in view of Huber et al (US 5,941,847).
Regarding claim 1, Quackenbush discloses a breast pump valve assembly comprising: a fluid chamber 130/168 defined between a first one-way valve 172/174 (fig 4) and a second one-way valve (¶53 – valve between 118 and 168 – essentially shown as 270 in fig 6), wherein the first one-way valve is configured to allow flow of fluid into the fluid chamber (¶48) and the second one-way valve is configured to allow flow of fluid out of the fluid chamber (fig 3, ¶46); and a displacement member 116 to draw fluid into the fluid chamber through the first one-way valve (¶44 and ¶53).
While Quackenbush substantially discloses the invention as claimed, it does not explicitly disclose a suction chamber for fluid connection to a negative pressure source; and a displacement member fluidly separating the suction chamber and the fluid chamber, wherein the displacement member is configured such that application of negative pressure to the suction chamber causes movement of the displacement member to thereby increase the volume of the fluid chamber and draw fluid into the fluid chamber through the first one-way valve.
In ¶74 of Quackenbush, it references (but does not explicitly “incorporate by reference”) US 5,941,847 – Huber et al.
Huber also discloses a breast pump, but one which is divided into a suction chamber 84 and fluid chamber 82 (fig 3) by a displacement member 80. This division by the displacement member isolates the vacuum source from the fluidic pathway (fig 3, Col.2 ll 2-6 and Col.3 ll 30-39). Displacement member 80 is fluidly separating the suction chamber and the fluid chamber, wherein the displacement member is configured such that application of negative pressure to the suction chamber causes movement of the displacement member to thereby increase the volume of the fluid chamber and draw fluid into the fluid chamber through the first one-way valve (“create a negative pressure within the shield extension” – Col.2 ll 2-6).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Quackenbush such that it has a suction chamber for fluid connection to a negative pressure source; and a displacement member fluidly separating the suction chamber and the fluid chamber, wherein the displacement member is configured such that application of negative pressure to the suction chamber causes movement of the displacement member to thereby increase the volume of the fluid chamber and draw fluid into the fluid chamber through the first one-way valve as taught by Huber to isolate the negative pressure source from the fluid pathway.
Regarding claims 2-5, while Quackenbush substantially discloses the invention as claimed, it does not explicitly disclose wherein the displacement member is configured such that, when pressure in the suction chamber is equal to or greater than pressure in the fluid chamber, the displacement member moves to thereby decrease the volume of the fluid chamber and direct fluid in the fluid chamber through the second one-way valve, wherein the displacement member is configured to move towards a vacuum port upon application of negative pressure to the suction chamber, wherein the displacement member is configured to move between a neutral position when the suction chamber is at atmospheric pressure, and a displaced position when the suction chamber is under negative pressure, nor wherein in the neutral position, the displacement member substantially closes at least a portion of the fluid chamber.
Quackenbush also discloses other embodiments which uses an automated pump (fig 6).
Aside from one of ordinary skill in the art appreciating this is the basic manner in which diaphragm pumps operate (pressure gradients caused by movement of diaphragm/membrane to cause fluid movement). Huber shows discloses such operations via fig 3 and Col.3 ll 40-67 (negative pressure to express milk into the device then positive pressure to move milk into the milk bottle).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Quackenbush such that the displacement member is configured such that, when pressure in the suction chamber is equal to or greater than pressure in the fluid chamber, the displacement member moves to thereby decrease the volume of the fluid chamber and direct fluid in the fluid chamber through the second one-way valve, the displacement member is configured to move towards a vacuum port upon application of negative pressure to the suction chamber, the displacement member is configured to move between a neutral position when the suction chamber is at atmospheric pressure, and a displaced position when the suction chamber is under negative pressure, in the neutral position, the displacement member substantially closes at least a portion of the fluid chamber as taught by Huber to both automate the vacuum control while isolating the fluid pathway from the pump.
Regarding claim 7, wherein the displacement member comprises a flexible diaphragm configured to deform upon application of negative pressure to the suction chamber (see combination in claim 1 and 80 of Huber).
Regarding claim 8, wherein at least one of the displacement member and first and second one-way valves are formed from a fluid impermeable flexible material (displacement member – see combination in claim 1 and 80 of Huber).
Regarding claim 9, while Quackenbush and Huber substantially disclose the invention as claimed, they do not disclose wherein the flexible material has a Shore-A hardness of from 30 to 70 Shore A.
Huber discloses the flexible material may be silicone (Col.3 ll 52), as does Applicant (page 15 ll 25 of specification dated 4/25/2023).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to determine the appropriate Shore-A hardness to achieve one-way passage of milk as part of a breast pump 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 (CCPA 1955).
Regarding claim 10, wherein the displacement member comprises a reciprocating member biased towards the fluid chamber (see combination in claim 1, Huber discloses natural shape is cylindrical, Col.3 ll 33 and fig 3, and is collapsed via vacuum - thus it is biased towards the fluid chamber).
Regarding claim 11, wherein at least one of the first and second one-way valves is a duck bill valve (¶64).
Regarding claim 12, further comprising a housing comprising an first housing 114 member defining the fluid chamber, and a second housing member (upper member of 116) defining the suction chamber (in the combination with Huber, the equivalent displacement member of Quackenbush would be the lower member of 116 in fig 3 as it is the membrane which creates the suction).
Regarding claim 13, wherein the displacement member is positioned between the first housing member and the second housing member (fig 3).
Regarding claim 14, wherein the first housing member is releasably coupled to the second housing member (fig 3).
Regarding claim 15, further comprising a fluid inlet 176, wherein the first one-way valve is configured to allow flow of fluid from the fluid inlet to the fluid chamber (fig 3).
Regarding claim 16, further comprising an inlet port 124 for fluidly coupling the inlet to a breast receiving part of a breast pump (fig 2).
Regarding claim 17, wherein the first housing member is configured as a lid for coupling to the opening of a fluid container (fig 3).
Regarding claim 18, wherein the first housing member comprises a fluid outlet (bottom opening of 168 in fig 3) configured to allow flow of fluid from the second one-way valve directly into a fluid container (figs 3 and 6).
Regarding claim 19, further comprising a fluid outlet (bottom opening of 168 in fig 3), wherein the second one-way valve is configured to allow flow of fluid from the fluid chamber to the outlet (figs 3 and 6).
Regarding claim 20, further comprising an outlet port for fluidly coupling the outlet to a fluid collection container (means by which second one-way valve is connected to fluid chamber, see enlarged means in fig 6 for example).
Regarding claim 22, while Quackenbush substantially discloses the invention as claimed, it does not disclose a suction chamber, wherein the displacement member fluidly separates the suction chamber and the fluid chamber.
Huber also discloses a breast pump, but one which is divided into a suction chamber 84 and fluid chamber 82 (fig 3) by a displacement member 80. This division by the displacement member isolates the vacuum source from the fluidic pathway (fig 3, Col.2 ll 2-6 and Col.3 ll 30-39). Displacement member 80 is fluidly separating the suction chamber and the fluid chamber, wherein the displacement member is configured such that application of negative pressure to the suction chamber causes movement of the displacement member to thereby increase the volume of the fluid chamber and draw fluid into the fluid chamber through the first one-way valve (“create a negative pressure within the shield extension” – Col.2 ll 2-6).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Quackenbush such that it includes a suction chamber, wherein the displacement member fluidly separates the suction chamber and the fluid chamber as taught by Huber to isolate the negative pressure source from the fluid pathway.
Regarding claim 23, further comprising a vacuum port for fluidly connecting the suction chamber to a negative pressure source (see upper part of 116 in fig 3 and how it connects to equivalent displacement member lower section of 116; publication 2004/0039330 is incorporated by reference and better labels the pump sections in fig 8).
Regarding claim 24, wherein the displacement member is configured such that application of negative pressure to the suction chamber causes movement of the displacement member to thereby increase the volume of the fluid chamber and draw fluid through the first one-way valve into the fluid chamber (See combination in claim 1 and Huber disclosure on how displacement member communicates generated vacuum to the fluid chamber).
Regarding claim 26, Quackenbush discloses a breast pump comprising: a breast receiving part 112 (fig 2), a fluid collection container 118 (fig 2), and a fluid flow path (pathway formed through 130/168) extending between the breast receiving part and the fluid collection container (fig 3); a fluid chamber 130/168 defined between a first one-way valve 172/174 and a second one-way valve in the fluid flow path (¶53 – valve between 118 and 168 – essentially shown as 270 in fig 6), wherein the first one-way valve is configured to allow flow of fluid from the breast receiving part into the fluid chamber (¶48), and the second one-way valve is configured to allow flow of fluid from the fluid chamber to the fluid collection container (¶53, fig 3).
While Quackenbush substantially discloses the invention as claimed, it does not disclose a suction chamber and a vacuum port for fluidly connecting the suction chamber to a negative pressure source; and a displacement member fluidly separating the suction chamber and the fluid chamber, wherein the displacement member is configured such that application of negative pressure to the suction chamber causes movement of the displacement member to thereby increase the volume of the fluid chamber and draw fluid from the breast receiving part through the first one-way valve into the fluid chamber.
In ¶74 of Quackenbush, it references (but does not explicitly “incorporate by reference”) US 5,941,847 – Huber et al.
Huber also discloses a breast pump, but one which is divided into a suction chamber 84 and fluid chamber 82 (fig 3) by a displacement member 80. This division by the displacement member isolates the vacuum source from the fluidic pathway (fig 3, Col.2 ll 2-6 and Col.3 ll 30-39). Displacement member 80 is fluidly separating the suction chamber and the fluid chamber, wherein the displacement member is configured such that application of negative pressure to the suction chamber causes movement of the displacement member to thereby increase the volume of the fluid chamber and draw fluid into the fluid chamber through the first one-way valve (“create a negative pressure within the shield extension” – Col.2 ll 2-6).
Quackenbush also discloses other embodiments (such as fig 6) which has a vacuum port 218 for communication with a negative pressure source (as does Huber in fig 3).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Quackenbush such that it includes a suction chamber and a vacuum port for fluidly connecting the suction chamber to a negative pressure source; and a displacement member fluidly separating the suction chamber and the fluid chamber, wherein the displacement member is configured such that application of negative pressure to the suction chamber causes movement of the displacement member to thereby increase the volume of the fluid chamber and draw fluid from the breast receiving part through the first one-way valve into the fluid chamber as taught by Huber to both fluidically isolate the negative pressure source from the fluid pathway and to automate the pumping (in the even the nursing mother gets tired of manually operating the pump).
Regarding claim 27, see claims 2-5 above (again, one of ordinary skill in the art would appreciate this is a basic functioning of membrane/diaphragm pumps)
Regarding claim 28, further comprising a negative pressure source fluidly connected to the vacuum port (see combination in claim 26 above and negative pressure sources in fig 3 of Huber and fig 6 of Quackenbush).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quackenbush et al (US 2008/0255503) in view of Huber et al (US 5,941,847) and O’toole et al (US 2020/0139026).
Regarding claim 29, while Quackenbush substantially discloses the invention as claimed, it does not disclose wherein the negative pressure source is one of: a piezoelectric pump, a diaphragm pump, a reciprocating pump, or a peristaltic pump.
O’toole discloses a breast pump which discloses the pump is a piezoelectric pump (¶144).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Quackenbush such that the negative pressure source is a piezoelectric pump as taught by O’toole as it is a known, specific type of pump used with breast pumps.
Allowable Subject Matter
Claim 6 is 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. The examiner did not find any teaching or suggestion for modifying closest art Quackenbush such that the displacement member, first and second one-way valves are integrally formed as it would require a significant rework of Quackenbush.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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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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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783