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 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 13-15 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 claim 13, Applicant requires performing the non-therapeutic expression of milk. It is unclear how expression of milk can be non-therapeutic. Applicant only mentions it once in their specification (page 4 of spec) but doesn’t provide any sort of definition/guidance. On the most basic level, expression of milk reduces engorgement of breasts (due to removal of milk filling them) and thus is inherently therapeutic. Further, Applicant’s method also appears to be therapeutic (controlling pressure source which limits stretching of nipple by limiting pressure; and limiting stretching of the nipple is a therapy). A rejection is made below as if “non-therapeutic” is not present.
In claim 13, “the pressure source” lacks antecedent basis. It is treated as “a pressure source”.
In claim 14, “the level of the under-pressure” lacks antecedent basis. It is treated as “a level of an under-pressure”.
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) 1, 8, 9, 12 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsson et al (US 2019/0240386).
Regarding claim 1, Larsson discloses a controller 201 (¶172) for a breast pump device, wherein the controller is for controlling operation of a pressure source of the breast pump device (¶172) to apply an under-pressure (¶122), the controller comprising: an input for receiving an input signal (from sensors - ¶172) representing a degree of stretching of the nipple during use of the breast pump device (¶122); and an output for controlling operation of the pressure source thereby to implement a maximum under-pressure level (Pmax) to be applied during use of the breast pump in dependence on the input signal (¶122 – alter vacuum level... to limit stretching of nipple; stretching of nipple is dependent on under-pressure level).
Regarding claim 8, adapted to control a frequency of a cyclic under-pressure waveform in dependence on the maximum under- pressure (¶17).
Regarding claim 9, Larsson discloses a breast pump device, comprising at least one breast receiving portion 10 configured to receive a breast of a user (fig 3a); a pressure source coupled to the at least one breast receiving portion and being configured to generate at least an under-pressure (¶s 100 and 101); a sensor 7/7’ for generating said input signal representing a degree of stretching of the nipple during use of the breast pump device (¶122); and the controller of claim 1 (see claim 1 above).
Regarding claim 12, wherein the sensor comprises: an optical sensor (¶122) for determining an occupied volume of the breast receiving portion.
Regarding claim 13, Larsson discloses computer-implemented method of controlling a breast pump device for performing the .
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) 2-7, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsson et al (US 2019/0240386) in view of Bourquin et al (US 2021/0093759).
Regarding claims 2 and 14, while Larsson substantially discloses the invention as claimed, it does not disclose the controller adapted to derive a relationship between the level of the under-pressure and the degree of stretching of the nipple, and to set the maximum under-pressure level based on the relationship.
Bourquin discloses a controller adapted to derive a relationship between the level of the under-pressure and the degree of stretching of the nipple, and to set the maximum under-pressure level based on the relationship (¶13, ¶109) in order to lower wear on the nipple and be more comfortable (¶13).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Larsson such that the controller is adapted to derive a relationship between the level of the under-pressure and the degree of stretching of the nipple, and to set the maximum under-pressure level based on the relationship as taught by Bourquin in order to lower wear on the nipple and be more comfortable for the user.
Regarding claim 3, while Larsson substantially discloses the invention as claimed, it does not disclose the controller adapted to derive the relationship during a calibration routine.
Bourquin discloses a controller adapted to derive the relationship during a calibration routine (¶109).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Larsson such that the controller is adapted to derive the relationship during a calibration routine as taught by Bourquin to achieve its advantages (see claim 2 above) in the most efficient manner.
Regarding claim 4, while Larsson substantially discloses the invention as claimed, it does not disclose wherein the calibration routine comprises the application of a ramp under-pressure waveform.
Bourquin discloses determining using calibration (¶109) and that the purpose is to lower wear on the nipple and be more comfortable for the user (¶13). But not how the particular pressures are calibrated for. One of ordinary skill in the art would appreciate that calibrations are performed by keeping other variables the same and changing the variable of interest to determine what happens at different amounts of the variable of interest.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Larsson such that the calibration routine comprises the application of a ramp under-pressure waveform as taught by Bourquin and with general knowledge of calibrations in order to determine appropriate pressures for lowering wear on the nipple and increased comfort while maximizing milk expression.
Regarding claim 5, while Larsson substantially discloses the invention as claimed, it does not disclose wherein the relationship has a maximum degree of stretching (Smax), and the maximum under-pressure level (Pmax) is selected as the under-pressure level corresponding to a predetermined fraction of the maximum degree of stretching.
Bourquin discloses wherein the relationship has a maximum degree of stretching (Smax), and the maximum under-pressure level (Pmax) is selected as the under-pressure level corresponding to a predetermined fraction of the maximum degree of stretching (¶109 – predetermined threshold value can be slightly below maximal elongation).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Larsson such that the relationship has a maximum degree of stretching (Smax), and the maximum under-pressure level (Pmax) is selected as the under-pressure level corresponding to a predetermined fraction of the maximum degree of stretching as taught by Bourquin in order to lower wear on the nipple and be more comfortable for the user.
Regarding claim 6, while Larsson substantially discloses the invention as claimed, it does not disclose the controller adapted to adjust the maximum under-pressure level (Pmax) during a breast pumping session.
Bourquin discloses the controller adapted to adjust the maximum under-pressure level (Pmax) during a breast pumping session (¶17 – adjust based on determined status of breast).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Larsson such that the controller is adapted to adjust the maximum under-pressure level (Pmax) during a breast pumping session as taught by Bourquin to lower wear on the nipple and be more comfortable while maximizing milk expression.
Regarding claim 7, while Larsson substantially discloses the invention as claimed, it does not disclose the controller is adapted to set the maximum under-pressure level further in dependence on additional parameters comprising one of more of: weather conditions; temperature conditions of the breast.
Bourquin discloses disclose the controller is adapted to set the maximum under-pressure level further in dependence on additional parameters comprising temperature conditions of the breast (¶102 – sets pressure level based on sensing presence of breast, as opposed to if a breast is not sensed).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Larsson such that the controller is adapted to set the maximum under-pressure level further in dependence on additional parameters comprising temperature conditions of the breast as taught by Bourquin to allow the device to detect whether a breast is present or not and operate accordingly.
Regarding claim 15, Larsson and Bourquin disclose a computer program comprising computer program code which is adapted, when said program is run on a controller (201 of Larsson) of a breast pump device which is for controlling operation of a pressure source of the breast pump device to apply an under-pressure (¶122 of Larsson), to implement the method of claim 14 (see modification of Larsson in claim 14 by Bourquin which results in the claimed computer program).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsson et al (US 2019/0240386).
Regarding claims 10 and 11, while Larsson substantially discloses the invention as claimed, it does not explicitly disclose a user input interface for receiving user feedback, nor the controller is adapted to set the maximum under-pressure level further in dependence on the user feedback.
Larsson does disclose pumping operation is adapted as stipulated by the mother (¶111). One of ordinary skill in the art some sort of user input interface is required for a mother to provide said stipulation(s).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify a user input interface for receiving user feedback, and the controller is adapted to set the maximum under-pressure level further in dependence on the user feedback as suggested by Larsson itself to allow the user to stipulate operation to increase operation efficiency.
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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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783