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 .
Claims 1-15 are examined in this office action.
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.
Claim(s) 1, 6, 11, 12, 13, and 15 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Reed et al. (WO 2023107791 A1).
Regarding claim 1, Reed discloses a breast pump (breast pump 10, Fig. 1) comprising:
a diaphragm (breast cup assembly 14, Fig. 1) for fitting over a portion of a breast ("The breast pump 10 also comprises a breast cup assembly 14 for receiving a nursing woman's breast …" - Para [0030]) thereby to create a cavity over said portion (See annotated Fig. 11);
a cover (housing 12, Fig. 1) for fitting over the diaphragm, wherein an actuation volume (fluid path 30, Fig. 8) is defined between the diaphragm and the cover;
an outlet (outlet 54, Fig. 11) from the cavity, wherein the breast pump is arranged such that the cavity is at least partially filled with expressed milk before the expressed milk flows to the outlet (See annotated Fig. 12);
an actuator (vibration unit 23, Fig. 2);
a pressure source (vacuum pump assembly 22, Fig. 2) for applying a pressure to the actuation volume ("… the vacuum pump assembly 22 may … apply positive pressure to portions of the breast cup assembly …" - Para [0032]); and
a controller (controller 20, Fig. 2) for controlling the actuator ("The controller is communicatively coupled to the vacuum pump assembly 22 and controls operation of the vacuum pump assembly 22 …" - Para [0033]),
wherein the controller is adapted to control the actuator to apply, during a vibration mode of the breast pump, pressure pulses to the actuation volume ("… the controller 20 may operate the vibration unit 23 in a … pulsed vibration mode." - Para [0053]) thereby to transfer vibrations to the breast at least partially through the expressed milk ("The vibration unit 23 is mounted within the cavity 38 of the housing 12 to transfer vibrations to the housing 12 … the vibration unit 23 vibrates the breast …" - Para [0053]).
Examiner interprets everything between the nipple, the valve 63, and the fluid path 30 to be the cavity.
PNG
media_image1.png
676
462
media_image1.png
Greyscale
PNG
media_image2.png
524
578
media_image2.png
Greyscale
Regarding claim 6, Reed discloses the breast pump (breast pump 10, Fig. 1) as recited above, wherein
the actuator (vibration unit 23, Fig. 2) is the pressure source ((vibration unit 23, Fig. 2), and the controller (controller 20, Fig. 2) is adapted to control the pressure source ("The controller is communicatively coupled to the vacuum pump assembly 22 and controls operation of the vacuum pump assembly 22 …" - Para [0033]) to apply the pulses to the actuation volume ("… the controller 20 may operate the vibration unit 23 in a … pulsed vibration mode." - Para [0053]) ("The vibration unit 23 is mounted within the cavity 38 of the housing 12 to transfer vibrations to the housing 12 … the vibration unit 23 vibrates the breast …" - Para [0053]).
Regarding claim 11, Reed discloses the breast pump (breast pump 10, Fig. 1) as recited above, wherein
the breast pump (breast pump 10, Fig. 1) further comprises a milk collection container (container 16, Fig. 11) and a valve (valve 54, Fig. 11) between the outlet from the cavity (outlet 54, Fig. 11) and the milk collection container (container 16, Fig. 11).
Regarding claim 12, Reed discloses the breast pump (breast pump 10, Fig. 1) as recited above, comprising
a wearable breast pump ("… a wearable electric breast pump …" - Para [0029]).
Regarding claim 13, Reed discloses a method ("… during operation of the breast pump 10 …" - Para [0048]) of operating a breast pump for the non-therapeutic expression of milk, wherein the breast pump comprises:
a diaphragm (breast cup assembly 14, Fig. 1) for fitting over a portion of a breast ("The breast pump 10 also comprises a breast cup assembly 14 for receiving a nursing woman's breast …" - Para [0030]) thereby to create a cavity over said portion (See annotated Fig. 11 above);
a cover (housing 12, Fig. 1) for fitting over the diaphragm, wherein an actuation volume (fluid path 30, Fig. 8) is defined between the diaphragm and the cover;
an outlet (outlet 54, Fig. 11) from the cavity, wherein the breast pump is arranged such that the cavity is at least partially filled with expressed milk before the expressed milk flows to the outlet (See annotated Fig. 12 above);
an actuator (vibration unit 23, Fig. 2);
a pressure source (vacuum pump assembly 22, Fig. 2) for applying a pressure to the actuation volume ("… the vacuum pump assembly 22 may … apply positive pressure to portions of the breast cup assembly …" - Para [0032]), and
a controller (controller 20, Fig. 2) for controlling the actuator ("The controller is communicatively coupled to the vacuum pump assembly 22 and controls operation of the vacuum pump assembly 22 …" - Para [0033]),
wherein the method comprises operating the controller such that the actuator applies, during a vibration mode of the breast pump ("… the controller 20 may operate the vibration unit 23 in a … pulsed vibration mode." - Para [0053]) , pressure pulses to the actuation volume thereby to transfer vibrations to the breast at least partially through the expressed milk ("The vibration unit 23 is mounted within the cavity 38 of the housing 12 to transfer vibrations to the housing 12 … the vibration unit 23 vibrates the breast …" - Para [0053]).
Regarding claim 15, Reed discloses a computer program comprising
computer program code means which is adapted ("…instructions stored in the memory 26, when executed by the processor 24, configured the controller 20 to control operation of the breast pump 10." - Para [0033]), when said program is run on processor (processor 24, Fig. 2) of the breast pump of claim 1 (See claim 1 above).
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.
Claim(s) 2-5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. (WO 2023107791 A1) in view of Bijoor (US Pub No. 20210361837 A1).
Regarding claim 2, Reed in view of Bijoor discloses the breast pump (Reed, breast pump 10, Fig. 1) as recited above, wherein
the controller (Reed, controller 20, Fig. 2) is adapted to control the pressure source (Reed, "The controller is communicatively coupled to the vacuum pump assembly 22 and controls operation of the vacuum pump assembly 22 …" - Para [0033]) to apply, during a milk expression mode (Reed, "For example, the controller 20 can operate the vibration unit 23 before or during the stimulating mode …" - Para [0053]), a vibration to the actuation volume (Reed, "The vibration unit 23 is mounted within the cavity 38 of the housing 12 to transfer vibrations to the housing 12 …" - Para [0053]).
Reed does not expressly disclose applying a cyclic pressure waveform.
Bijoor teaches applying a cyclic pressure waveform (vacuum pressure waveform 350, Fig. 3B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the breast pump of Reed to include applying a cyclic pressure waveform as taught by Bijoor to help extract milk from the breast (Bijoor, Para [0085]).
Regarding claim 3, Reed in view of Bijoor discloses the breast pump (Reed, breast pump 10, Fig. 1) as recited above, wherein the controller (Reed, controller 20, Fig. 2) is adapted to control the actuator (Reed, "The controller is communicatively coupled to the vacuum pump assembly 22 and controls operation of the vacuum pump assembly 22 …" - Para [0033]) to apply the pulses of the vibration mode (Reed, "… the controller 20 may operate the vibration unit 23 in a … pulsed vibration mode." - Para [0053]) :
before the vibration of the expression mode (Reed, "For example, the controller 20 can operate the vibration unit 23 before or during the stimulating mode …" - Para [0053]);
or simultaneously with the cyclic pressure waveform of the expression mode.
Reed does not expressly disclose that the controller is adapted to … apply the pulses of the vibration mode: before the cyclic pressure waveform of the expression mode.
Bijoor teaches that the controller is adapted to … apply the pulses of the vibration mode: before the cyclic pressure waveform (vacuum pressure waveform 350, Fig. 3B) of the expression mode.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the breast pump of Reed to include that the controller is adapted to … apply the pulses of the vibration mode: before the cyclic pressure waveform of the expression mode as taught by Bijoor to help extract milk from the breast (Bijoor, Para [0085]).
Examiner interprets the expression mode to be the stimulating mode.
Regarding claim 4, Reed in view of Bijoor discloses the breast pump (Reed, breast pump 10, Fig. 1) as recited above, wherein
the pulses of the vibration mode (Reed, “… the controller 20 may operate the vibration unit 23 in a … pulsed vibration mode.” – Para [0053])
Reed does not expressly disclose that the pulses of the vibration mode have a frequency in the range 1 to 250Hz, for example 10 to 250Hz, and wherein a cycle frequency of the cyclic pressure waveform is below 2Hz.
Bijoor teaches that the pulses of the vibration mode have a frequency in the range 1 to 250Hz, for example 10 to 250Hz ("The one or more frequencies may comprise at least 1 Hz or greater …" - Para [0131]), and wherein a cycle frequency of the cyclic pressure waveform (vacuum pressure waveform 350, Fig. 3B) is below 2Hz ("The one or more frequencies may comprise at least 1 Hz or greater …" - Para [0131]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the breast pump of Reed to include that the pulses of the vibration mode have a frequency in the range 1 to 250Hz, for example 10 to 250Hz, and wherein a cycle frequency of the cyclic pressure waveform is below 2Hz as taught by Bijoor to help extract milk from the breast (Bijoor, Para [0085]).
Examiner interprets that 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.
Regarding claim 5, Reed in view of Bijoor discloses the breast pump (Reed, breast pump 10, Fig. 1) as recited above, wherein
the pulses of the vibration mode (Reed, "… the controller 20 may operate the vibration unit 23 in a … pulsed vibration mode." - Para [0053])
Reed does not expressly disclose that the pulses of the vibration mode have a higher frequency than the cycle frequency of the cyclic pressure waveform.
Bijoor teaches that the pulses of the vibration mode have a higher frequency ("The one or more frequencies may comprise at least 1 Hz or greater …" - Para [0131]) than the cycle frequency of the cyclic pressure waveform (vacuum pressure waveform 350, Fig. 3B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the breast pump of Reed to include that the pulses of the vibration mode have a higher frequency than the cycle frequency of the cyclic pressure waveform as taught by Bijoor to help extract milk from the breast (Bijoor, Para [0085]).
Examiner interprets that Bijoor discloses multiple different frequencies that can be applied to the multiple different modes of Reed (constant vs pulsed vibration modes) and 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.
Regarding claim 14, Reed in view of Bijoor discloses the method (Reed, "… during operation of the breast pump 10 …" - Para [0048]) as recited above, wherein
the method comprises operating the controller (Reed, controller 20, Fig. 2) such that the pressure source to applies (Reed, "The controller is communicatively coupled to the vacuum pump assembly 22 and controls operation of the vacuum pump assembly 22 …" - Para [0033]), during a milk expression mode (Reed, "For example, the controller 20 can operate the vibration unit 23 before or during the stimulating mode …" - Para [0053]), a vibration to the actuation volume (Reed, "The vibration unit 23 is mounted within the cavity 38 of the housing 12 to transfer vibrations to the housing 12 …" - Para [0053]).
Reed does not expressly disclose that the controller applies a cyclic pressure waveform.
Bijoor teaches that the controller applies a cyclic pressure waveform (vacuum pressure waveform 350, Fig. 3B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Reed to include that the controller applies a cyclic pressure waveform as taught by Bijoor to help extract milk from the breast (Bijoor, Para [0085]).
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. (WO 2023107791 A1) in view of Makower et al. (WO 2016014469 A1).
Regarding claim 7, Reed in view of Makower discloses the breast pump (Reed, breast pump 10, Fig. 1) as recited above, comprising
a vibrator (Reed, vibration unit 23, Fig. 2) for imparting the pulses to the actuation volume (Reed, "The vibration unit 23 is mounted within the cavity 38 of the housing 12 to transfer vibrations to the housing 12 …" - Para [0053]).
Reed does not expressly disclose a coupling tube between the pressure source and the cover, wherein the actuator comprises a vibrator for imparting the pulses to the actuation volume via the coupling tube.
Makower teaches a coupling tube (tube 32, Fig. 3A) between the pressure source (pumping region 30, Fig. 1) and the cover (breast adapter 10, Fig. 1), wherein the actuator (driver 44, 46, Fig. 1) comprises a vibrator (compression elements 36, 38, Fig. 3) for imparting the pulses to the actuation volume via the coupling tube ("Two active compression elements 36, 38 are operable to compress and allow decompression of the resilient tube 32 …" - Para [00138]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the breast pump of Reed to include a coupling tube between the pressure source and the cover, wherein the actuator comprises a vibrator for imparting the pulses to the actuation volume via the coupling tube as taught by Makower for pumping fluid (milk) (Makower, Para [00147]).
Regarding claim 8, Reed in view of Makower discloses the breast pump (Reed, breast pump 10, Fig. 1) as recited above,
Reed does not expressly disclose that wherein the vibrator is for: deforming the coupling tube; or applying pulses to the fluid in a branch which connects to the coupling tube.
Makower teaches that wherein the vibrator (compression elements 36, 38, Fig. 3) is for: deforming the coupling tube ("Two active compression elements 36, 38 are operable to compress and allow decompression of the resilient tube 32 …" - Para [00138]); or applying pulses to the fluid in a branch which connects to the coupling tube.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the breast pump of Reed to include that wherein the vibrator is for: deforming the coupling tube; or applying pulses to the fluid in a branch which connects to the coupling tube as taught by Makower for pumping fluid (milk) (Makower, Para [00147]).
Regarding claim 9, Reed in view of Makower discloses the breast pump (Reed, breast pump 10, Fig. 1) as recited above, wherein
the actuator (Reed, vibration unit 23, Fig. 2) comprises a vibrator (Reed, vibration unit 23, Fig. 2) for imparting the pulses to the actuation volume (Reed, "The vibration unit 23 is mounted within the cavity 38 of the housing 12 to transfer vibrations to the housing 12 …" - Para [0053]), from the outside of the cover.
Reed does not expressly disclose that the actuator comprises a vibrator for imparting pluses to the actuation volume from outside of the cover.
Makower teaches that the actuator comprises a vibrator (driver 900, Fig. 32C) for imparting pluses to the actuation volume from outside of the cover (driver 900, Fig. 32C).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the breast pump of Reed to include that the actuator comprises a vibrator for imparting pluses to the actuation volume from outside of the cover as taught by Makower for pumping fluid (milk) (Makower, Para [00147]).
Regarding claim 10, Reed in view of Makower discloses the breast pump (Reed, breast pump 10, Fig. 1) as recited above, wherein
Reed does not expressly disclose that the vibrator comprises a valve.
Makower teaches that the vibrator (compression elements 36, 38, Fig. 3) comprises a valve (“Fig. 4E shows compression elements 36 fully compressing region 40, thereby functioning as a closed valve …” – Para [00154]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the breast pump of Reed to include that the vibrator comprises a valve as taught by Makower for pumping fluid (milk) (Makower, Para [00147]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights