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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheng (CN 110237323).
Regarding Claim 1, Cheng teaches (Fig 1) A physiotherapy structure, comprising:
a breast shield (1) configured to apply to a breast pump (See Pg. 2 lines 11-12 teaching how the device is a breast pump), comprising a first side (side where 12 points to) configured to contact a breast (side where 12 points to would contact a breast) and a second side (outer surface of 1, opposite surface of 12) configured to not to contact the breast (surface of 1 that does not contact the breast);
at least one physiotherapy unit (2,3), comprising at least one vibrator (the massage wheel is considered to be a vibrator) and configured to conduct an physiotherapy action to the breast (Pg. 3 lines 29-36 teaching the rotating wheel and how it massages the breast this is considered a ‘physiotherapy action’), detachably connected to the second side of the breast shield (See last paragraph Pg. 3 how things are detachable connected to breast shield 1); and
an electronic control system electrically connected to the at least one physiotherapy unit (See Pg. 2 lines 11-12 teaching how the device is a breast pump; therefore electronic control system).
Regarding Claim 2, Cheng teaches the physiotherapy structure of claim 1, wherein the breast shield comprises: a nipple accommodating portion (11), comprising a first opening (right side opening of 11) and a second opening (left side opening of 11);
and a flange (inner surface of 1), being connected to the second opening (left side opening of 11) and being configured to abut against the breast (where breast/ nipple is accommodated within 1).
Regarding Claim 3, Cheng teaches the physiotherapy structure of claim 2, wherein the flange is or at least partially made of the flexible material (Pg. 4 first full paragraph teaches breast shield 1 is made of silicone gel, and 11 is a part of 1).
Regarding Claim 4, Cheng teaches the physiotherapy structure of claim 1, wherein the at least one physiotherapy unit comprises at least one of a vibration member (rotary wheel is considered to have the same result of vibration member), a kneading member (rotatory massage is considered same function as kneading member).
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) 5-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng (CN 110237323) in view of Makower et al. (US 20200061266 hereinafter “Makower”).
Regarding Claim 5, Cheng teaches (Fig 1) a breast pump device, comprising:
a breast shield (1) configured to apply to a breast pump (See Pg. 2 lines 11-12 teaching how the device is a breast pump), comprising a first side (side where 12 points to) configured to contact a breast (side where 12 points to would contact a breast) and a second side (outer surface of 1, opposite surface of 12) configured to not to contact the breast (surface of 1 that does not contact the breast);
a host (4), comprising a housing (2,3,4) connected to the second side (outer side of 1 opposite of 12) of the breast shield (1) or at least partially connected to the breast shield (connected through components 2 and 3):
a physiotherapy unit (2,3), comprising at least one vibrator (the massage wheel is considered to be a vibrator) and configured to conduct an physiotherapy action to the breast (Pg. 3 lines 29-36 teaching the rotating wheel and how it massages the breast this is considered a ‘physiotherapy action’), wherein the at least one physiotherapy unit (2,3) is provided on a surface of the housing towards the breast shield (1) and detachably connected to the second side of the breast shield (See last paragraph Pg. 3 how things are detachable connected to breast shield 1); and
an electronic control system electrically connected to the at least one physiotherapy unit (See Pg. 2 lines 11-12 teaching how the device is a breast pump; therefore electronic control system).
Cheng does not specify a negative pressure assembly at least partially provided in the housing; and a milk storage assembly communicated with the breast shield.
Makower teaches (Figs 1-3, 6, 12 and 31a-33) a breast pump (100) device capable of applying a physiotherapy action to a breast, comprising:
a breast shield (10) provided with a first side (14) contacting a breast and a second side (outer surface of 10 that is surrounded by 100) not contacting the breast;
a physiotherapy unit (30, 90, 84, 86) abutted against or detachably connected to the second side (outer surface of 10 that is surrounded by 100) of the breast shield (10);
an electronic control system (52) electrically connected to the physiotherapy unit;
a host comprising a housing (34), wherein the housing is connected to the second side of the breast shield (100) or at least partially connected to the breast shield, the at least one physiotherapy unit (30) is provided on a surface of the housing towards the breast shield (10), and the at least one physiotherapy unit (90, 94, 84, 86) is configured to apply the physiotherapy action to the breast through the breast shield (10);
a negative pressure assembly (36, 38) at least partially provided in the housing; and
a milk storage assembly (60) communicated with the breast shield (10);
wherein the electronic control system (52) is further electrically connected to the negative pressure assembly (36, 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the breast pump of Cheng such that it includes a negative pressure assembly at least partially provided in the housing; and a milk storage assembly communicated with the breast shield as taught by Makower. One of ordinary skill in the art would have been motivated to do so in order to assess the pumping function and maintain an acceptable pumping negative pressure profile for a wide variety of milk expression volumes (Makower [0144]).
Regarding Claim 6, the combination of Cheng an Makower teaches all element of claim 5 as described above. Cheng further teaches the breast pump device wherein the at least one vibrator (2,3) comprises at least one vibration motor (5) configured to vibratingly massage the breast (Pg. 3 last paragraph – Pg. 4 line 2).
Regarding Claim 7, the combination of Cheng an Makower teaches all element of claim 6 as described above. The combination does not specify the breast pump device wherein the at least one vibration motor comprises a plurality of vibration motors provided at intervals along a circumferential direction of the flange.
Makower teaches [0209] an embodiment with multiple motors (84), and the plurality of the vibration motors (84) are provided at intervals along a circumferential direction of the flange (See Fig 31a and 31b where 84 is provided at intervals along flange of 10a (outer edge of 10a)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vibration motors of Cheng such that the at least one vibration motor comprises a plurality of vibration motors provided at intervals along a circumferential direction of the flange as taught by Makower. One of ordinary skill in the art would have been motivated to do so in order to effect different massage actions and improve milk extraction (Makower [0209]).
Regarding Claim 8, the combination of Cheng an Makower teaches all element of claim 6 as described above. The combination does not specify the breast pump device wherein a surface of the flange towards the host is provided with at least one recessed groove having a recessed direction away from the host at least one of a bottom of the at least one recessed groove or a sidewall of the at least one recessed groove is made of a flexible material, the at least one vibration motor is at least partially accommodated in the at least one recessed groove, abutted against the bottom of the recessed groove, and is protruded from a surface of the host towards the breast shield; the sidewall of the at least one recessed groove is sleeved with at least a part of a structure of the at least one vibration motor and one side surface of the flange near the breast is flat.
Makower teaches the breast pump device wherein the at least one vibration motor (84) is protruded from a surface of the host towards the breast shield (See Figs 31a,b 84 is protruding from a surface towards breast shield), a surface of the flange (10) towards the host is provided with at least one recessed groove (interpreted that where 84 is located on ring in Fig 31b is a groove), a recessed direction of the at least one recessed groove is away from the host (groove faces the breast, therefore away from the host/housing), and the at least one vibration motor (84) is at least partially accommodated in the at least one recessed groove (See Fig 31b); and at least a bottom of the at least one recessed groove and/or at least a sidewall of the at least one recessed groove are made of a flexible material (See [0137] teaching 12 is made of compliant material), the at least one vibration motor (84) is abutted against the bottom of the recessed groove (See Fig 31b), the sidewall of the at least one recessed groove is sleeved with at least a part of a structure of the at least one vibration motor (See fig 31b), and one side surface of the flange near the breast is flat (any surface next to the ring (‘recess’) with 84 is considered flat without the protrusions of the motor 84).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the breast pump device of Cheng such that a surface of the flange towards the host is provided with at least one recessed groove having a recessed direction away from the host at least one of a bottom of the at least one recessed groove or a sidewall of the at least one recessed groove is made of a flexible material, the at least one vibration motor is at least partially accommodated in the at least one recessed groove, abutted against the bottom of the recessed groove, and is protruded from a surface of the host towards the breast shield; the sidewall of the at least one recessed groove is sleeved with at least a part of a structure of the at least one vibration motor and one side surface of the flange near the breast is flat as taught by Makower. One of ordinary skill in the art would have been motivated to do so in order to allow for a design that allows for different patterns of massage (Makower [0209]).
Regarding Claim 9, the combination of Cheng and Makower teaches all elements of claim 8 as described above. Makower further teaches the breast pump device wherein the flange (outer edge of 10) comprises a flange main body (Body seen in Fig 31b where 84 is located), and the at least one recessed groove (ring where 84 is located in Fig 31b) is integrated or detachably fixed on the flange main body (Fig 31b).
Regarding Claim 10, the combination of Cheng and Makower teaches all elements of claim 9 as described above. Makower further teaches the breast pump device wherein the flange main body and the at least one recessed groove are integrated (See Fig 31b), and are made of the flexible material or a semi-flexible material (See [0137] teaching how the flange and inner surface are made of compliant material).
Regarding Claim 11 the combination of Cheng and Makower teaches all elements of claim 5 as described above. Makower further teaches the breast pump device, further comprising: a power supply system (48) electrically connected to the negative pressure assembly (36, 38), the physiotherapy unit (30, 84, 86, 90, 94) and the electronic control system (52), and configured to provide a power to the negative pressure assembly, the physiotherapy unit and the electronic control system (See [0144] and [0210]).
Claim(s) 12-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 20200061266) in view of Chen (US 11554199).
Regarding Claim 12, Makower teaches (Figs 1-3, 6 and 12) a breast pump, comprising:
a breast shield (10) comprising:
a flange (Fig 2, outer edge of 10 where 12 points to), configured for fitting with a breast, and a nipple accommodating portion (Fig 2, inner portion of 10, where 14 points to), in communication with the flange and configured for accommodating a nipple of the breast (see Fig 12);
a host comprising:
a housing (34), provided with an accommodating chamber (where 30 is located) in the housing, and an avoiding hole (see 230 in Fig 6) is provided at a middle of the housing (34), wherein an opening of the nipple accommodating portion (opening of 10, see 14 in fig 2) is penetrated through the avoiding hole, and a negative pressure assembly (36, 38) is at least partially provided in the accommodating chamber (where 30 is located within 34), and being configured to directly or indirectly apply a negative air pressure to the nipple accommodating portion (See [0144] teaching negative pressure to area where nipple is) to deform the elastic deformation structure; and
a milk storage assembly (60) detachably connected (See [0014] and [0193] teaching milk storage container detachable) to the host (34) and communicated with the other opening of the nipple accommodating portion (See [0193] teaching how 60 is in communication with tube 32; see Fig 1 and 2 where nipple accommodating portion 14 is in communication with the tube 32).
Makower does not specify at least one elastic deformation structure, seated between the flange and the nipple accommodating portion, configured to deform to massage the breast in response to a negative air pressure being applied to the nipple accommodating portion; wherein the negative pressure assembly being configured to directly or indirectly apply a negative air pressure to the nipple accommodating portion to deform the elastic deformation structure.
Chen teaches (Fig 9) an elastic deformation structure (22, 24, 221) between a flange (23) and a nipple accommodating portion (pointed end of 22) that is configured to deform and massage the breast in response to negative air pressure being applied to the nipple accommodating portion (Col 5 lines 15-37); wherein the negative pressure assembly being configured to directly or indirectly apply a negative air pressure to the nipple accommodating portion to deform the elastic deformation structure (Col 5 lines 15-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the breast pump of Makower such that it includes at least one elastic deformation structure, seated between the flange and the nipple accommodating portion, configured to deform to massage the breast in response to a negative air pressure being applied to the nipple accommodating portion; wherein the negative pressure assembly being configured to directly or indirectly apply a negative air pressure to the nipple accommodating portion to deform the elastic deformation structure as taught by Chen. One of ordinary skill in the art would have been motivated to do so in order to better suction/withdraw breast milk with the negative pressure and suction of the device (Chen Col 5 lines 26-29).
Regarding Claim 13, the combination of Makower and Chen teaches the breast pump of claim 12, wherein the breast shield (Makower 10) is configured to apply in a breast pump device or a breast massage device to be fitted with a breast (See Makower [0013] teaching how the adapter 10 is attachable to a pump system), the elastic deformation structure is integrated with or detachably connected with the breast shield (See Chen 9, how the elastic deformation structure 22, 24, 221 is integrated/connected to the device).
Regarding Claim 14, the combination of Makower and Chen teaches the breast pump of claim 12, wherein the at least one elastic deformation structure (22, 24) is provided at a connection between the flange and the nipple accommodating portion (See Chen Fig 9, the structure 221 extend between the flange and nipple accommodating portion therefore providing a connection between the two).
Regarding Claim 15, the combination of Makower and Chen teaches he breast pump of claim 12, wherein the at least one elastic deformation structure (Chen 22, 24, 221) is provided below a midline of the nipple accommodating portion (see Chen Fig 9, since 221 is circumferentially around the entire device, at least one would be located below a midline of the nipple accommodating portion).
Regarding Claim 16, the combination of Makower and Chen teaches the breast pump of claim 12, wherein the at least one elastic deformation structure comprises: a plurality of elastic deformation structures being evenly provided along a circumferential direction of the flange (See Chen Fig 9, 221 is evenly provided along a circumferential direction of the flange).
Regarding Claim 17, the combination of Makower and Chen teaches the breast pump of claim 12, wherein the flange (Makower outer edge of 12 as seen in annotated Fig 12.1) is made of a flexible material (see Makower [0137] teaching a compliant material), and a thickness of the flange is greater than a thickness of the elastic deformation structure (See Fig 2, the flange (outer edge of 12) is thicker than the rest of the deformation portion 12).
Regarding Claim 18, the combination of Makower and Chen teaches the breast pump of claim 17, wherein the flange is integrated with the at least one elastic deformation structure (See Chen Fig 9, 221 is integrated with rest of the structure 20).
Regarding Claim 19, the combination of Makower and Chen teaches the breast pump of claim 13, wherein the nipple accommodating portion (Makower 14) is made of a rigid material (See Makower [0137] 14 is rigid or semi rigid).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 20200061266) in view of Otoole et al (US 20180361040 hereinafter “Otoole”)
Regarding Claim 20, Makower teaches all elements of claim 13 as described above. Makower does not specify the breast pump wherein the breast shield further comprises: a diaphragm bracket; wherein the diaphragm bracket is provided on the breast shield and is communicated with the breast shield, and a pressure diaphragm is provided on the diaphragm bracket.
Otoole teaches (fig 3) a breast shield (7) with a diaphragm bracket (19a); wherein the diaphragm bracket (19a) is provided on the breast shield (7) and is communicated with the breast shield (7), and a pressure diaphragm (13) is provided on the diaphragm bracket (19a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the breast shield of Makower such that it includes a diaphragm bracket; wherein the diaphragm bracket is provided on the breast shield and is communicated with the breast shield, and a pressure diaphragm is provided on the diaphragm bracket as taught by Otoole. One of ordinary skill in the art would have been motivated to do so in order to transfer the pressure from the pump to the milk-collection side of the system (Otoole [0109]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 5 and 12 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 7/2/2026.
Applicant's arguments filed 7/2/2026 have been fully considered but some are not persuasive.
As to the remarks on Pgs. 10-11, the applicant argues that the vibration drivers and rollers of Makower are not a physiotherapy unit with a vibration motor. The applicant argues that the vibration driver and rollers of Makower are used primarily for assistance of milk suction and therefore do not provide any “physiotherapy” and there is no explicit description of motors therefore Makower does not read on these elements. The examiner does not find this persuasive. The result of the rollers and vibration drivers is providing a massaging/vibrating effect on the breast, which allows for assistance with milk suction. This is the massaging/vibrating effect is considered a “physiotherapy” action and therefore the roller would be a “physiotherapy” unit. Furthermore the vibration driver would require some sort of “motor” for actuation, therefore it is interpreted that Makower meets these elements of the claim. Regardless, the examiner has provided a different rejection due to the amendments to the claim.
As to the remarks at the end of Pg. 12 and first paragraph of Pg. 13, the applicant argues that Makower teaches a positive compression not a negative air compressive system. The examiner does not find this persuasive. Makower [0144] teaches a negative pressure pumping system in the housing that could be used with the device. The examiner has also provided a different rejection for claim 12 due to the amendments to the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang (US 11712500) teaches a breast pump with a breast shield comprising multiple deformation portions.
Dorbrusskin (CN 116212137) teaches a breast pump with a breast shield and a diaphragm.
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 NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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, 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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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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