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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/15/23;10/29/25 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
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 1-4, 6-8, 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Schijndel et al. (US 2012/0116298) (“Van Schijndel”). Van Schijndel discloses:
(claim 1) A controller 220 for a breast pump device (Fig. 3), wherein the controller is for controlling operation of a pressure source 152 of the breast pump device to apply an under-pressure (150,170; modes/pressures are changed based on the movement of the diaphragm 140 up or down [0075-0076,0062]), the controller comprising: an input (200, sensed or computer algorithm [0072,0074]) for receiving an input signal relating to a milk flow during a breast pumping session using the breast pump device; and an output (trigger signal 180, [0075,0072]) for controlling operation of the pressure source in dependence on the input signal, thereby to switch, during the breast pumping, between three modes [0075-0076,0063-0064]: a low energy mode (relaxation mode or neutral mode) with a first pressure profile of the pressure source; an expression mode (expression mode) with a second pressure profile of the pressure source; and a stimulation mode (stimulation effect, let-down mode-instigates an MER) with a third, pressure profile of the pressure source, wherein the first to third pressure profiles are all different, wherein the output is for controlling operation of the pressure source to follow a sequence comprising the stimulation mode followed by alternating expression modes and low energy modes, [0063-0064].
(claim 8) A breast pump device 100, comprising at least one breast receiving portion 111 configured to receive a breast of a user; a pressure source 152 coupled to the at least one breast receiving portion and being configured to generate at least an under-pressure (150,170; modes/pressures are changed based on the movement of the diaphragm 140 up or down [0075-0076,0062]); a sensor 210,230 for generating said input signal 200 relating to the milk flow during a breast pumping session; and the controller 220 of claim 1 (see above).
(claim 12, 15) see claims 1 and 8 in combination, above and [0074,0088—computer program, algorithm]
Claim 2: the breast pumping session comprises a continuous sequence of said time periods of the low energy mode and the expression mode after the stimulation mode. [0063-0064]
Claim 3, 13: the low energy mode has a lower electrical power consumption than each of the expression mode and the stimulation mode. [0064]
Claim 4, 13: the low energy mode has a lower maximum under-pressure level and/or a longer dwell in time and/or a longer dwell out time than the expression mode. [0064]
Claim 6, 14: the input signal indicates at least one of: the detection of milk drops; a cumulative milk flow; a milk flow gradient; and a trend in the milk flow gradient. [0008,0071]
Claim 7: the controller adapted to derive a relationship between the cumulative milk flow and time for a particular user, and to derive a program of operation of the pressure source for the particular user from the relationship [0071-0072,0074-0076,0062-0064,0068].
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Van Schijndel in view of Barack (US 2018/0110906).
Van Schijndel discloses the invention as substantially claimed (see above), but does not directly disclose the pressure at which the breast pump device operates in the various modes. Barack, in the analogous art teaches a similar dynamically adaptive breast pump device which operates above 20 kPa pressure for expression mode and below 20 kPa pressure in low energy mode [0037], (Van Schijndel [0062]). 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).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Van Schijndel in view of Gaskin et al. (US 2017/0021068) (“Gaskin”).
Van Schijndel discloses the invention as substantially claimed (see above), but does not directly disclose the sensor being an optical sensor. Gaskin, in the analogous art, teaches a similar processing unit for sensing characteristics of milk expression and using that sensing data to help automate the management and monitoring of milk production [0085-0086]. One of the sensors used in Gaskin is an optical sensor (photodiode/LED sensor) [0085]. It is known that these sensors comprise an optical emitter and an optical detector arrangement. 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 use the photodiode sensor as taught by Gaskin in the system of Van Schijndel as another type of sensor to improve convenience for the user [Gaskin 0086].
With respect to claim 11, the device of Van Schijndel is a battery-operated 160
Conclusion
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/DEANNA K HALL/Primary Examiner, Art Unit 3783