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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 2, 4-18, 27 and 28) in the reply filed on 2/23/2026 is acknowledged.
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 17 and 18 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 17, Applicant requires one or more openings, wherein each of the one or more openings have a diameter different from one another. It is unclear how in the minimum embodiment of one opening, the opening can have a diameter different from another. This leads to a similar issue in clam 18 with a minimum embodiment of one opening.
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) 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Conner et al (US 2016/0120763).
Regarding claim 28, Conner discloses a breastfeeding aid device, comprising: a nipple shield (figs 11-13B) comprising an outer wall 110a and a top surface defined at a distal end of the nipple shield (fig 12B), wherein a circumference of the outer wall tapers towards the top surface (fig 12B), and wherein the outer wall and the top surface define a cavity (interior of 110a); a plurality of openings defined in the top surface (unlabeled in fig 11; 112 in fig 2); a channel 116a defined within the outer wall (fig 12B); and a fluid lumen coupled to the channel 132, wherein the fluid lumen is configured to couple to a reservoir holding a fluid (via 126a, see ¶40, ¶50 and reservoir 150 in fig 17B); wherein a first opening of the plurality of openings provides access to the cavity and a second opening of the plurality of openings provides access to the channel (fig 12B, both/all four openings provide access to both the cavity and the channel); wherein the cavity is shaped to fit a nipple of a subject (¶38); and wherein the breastfeeding aid device is configured such that a suction force on the nipple shield stimulates the nipple to produce breast milk accessible via the first opening and creates a negative pressure in the channel to pull the fluid from the reservoir, through the fluid lumen, through the channel, and through the second opening when the fluid lumen is coupled to the reservoir (¶53, both first and second openings are used for milk and fluid from the reservoir).
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, 4, 5, 8-14, 16 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conner et al (US 2016/0120763) in view of Scheuerle et al (US 2020/0206083).
Regarding claim 1, Conner discloses a breastfeeding aid device, comprising: a reservoir 150 (while supplemental fluid source 150 is not shown in figs 11-13B as per ¶40 and ¶50 it is used with attachment portion 126a) having a first opening (exit from reservoir); at least one fluid lumen 132/152 fluidly coupled to the first opening of the reservoir (figs 11 and 17B); and a nipple shield 102a comprising a crown 110a and a channel defined through an outer wall of the crown (holes in crown, unlabeled in figs 11-13B, but labelled as 112 in fig 2), wherein the crown is configured to be positioned over a nipple of a subject such that the nipple is sealingly contained within a cavity defined by the crown (¶38) and wherein the channel is fluidly coupled to the first opening of the reservoir by the at least one fluid lumen (fig 11); wherein the breastfeeding aid device is configured to move a fluid from within the reservoir, through the at least one fluid lumen, and through the channel, and to form a negative pressure within the cavity [[to]]that stimulates the nipple of the subject when a suction force is applied to an exterior of the crown (¶53, suction force is transmitted to interior of nipple shield via channels 112, the suction force moves the fluid and stimulates the nipple).
While Conner substantially discloses the invention as claimed, it does not disclose a flow selector positioned within the first opening, wherein the flow selector is configured to provide a predetermined flow rate of fluid flowing from the reservoir.
Scheuerle discloses a flow selector 432 positioned within the first opening (exit from reservoir 140/180) and configured to provide a predetermined flow rate of fluid flowing from the reservoir (¶34 – valve 432 controls/regulates flow of fluid from the supply source).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Conner with a flow selector positioned within the first opening, wherein the flow selector is configured to provide a predetermined flow rate of fluid flowing from the reservoir as taught by Scheuerle to control/regulate flow of fluid from the supply source.
Regarding claim 4, the reservoir comprises a syringe body (¶54).
Regarding claim 5, while Conner substantially discloses the invention as claimed, it does not disclose the reservoir comprises a flexible pouch.
Conner shows a pouch-like reservoir in fig 17A, similar to an IV bag.
Scheuerle discloses the reservoir being flexible to facilitate release of fluid (¶42).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Conner such that the reservoir comprises a flexible pouch as taught by Scheuerle to allow it to be squeezed and facilitate release of fluid.
Regarding claim 8, further comprising an additional fluid lumen 126a positioned between the reservoir and the at least one fluid lumen and coupled to the reservoir and to the at least one fluid lumen (figs 11 and 17B).
Regarding claim 9, wherein the crown forms a tapered structure that tapers towards a distal end of the crown such that the nipple fits inside the cavity (fig 11, ¶38).
Regarding claim 10, while Conner substantially discloses the invention as claimed, it does not disclose the crown is configured to collapse when compressed externally such that opposing sides of the crown compress towards one another forming an oval shape in a distal wall of the crown.
Scheuerle discloses the nipple shield (including the crown) is made of a flexible and/or elastic material to easily conform to the shape of the breast of the wearer (¶26). Further, the area which is placed in the infant’s mouth facilitates force transfer and a normal mouth-feel in the oral cavity (¶135; which includes slight collapse of the nipple). Also in ¶135, Scheuerle discloses the section of the device adjacent the breast is desired to be thicker to give it structural integrity (suggesting the other section lacks at least a bit of structural integrity)
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Conner such that the crown is made of a flexible and/or elastic material (which is configured to collapse when compressed externally) as taught by Scheuerle to easily conform to the shape of the breast of the wearer and to mimic a normal mouth-feel for the infant.
Further, one of ordinary skill in the art would appreciate that making the cylindrical/frustoconical structure of Conner flexible/elastic as taught by Scheuerle would collapse such that opposing sides of the crown compress towards one another forming an oval shape in a distal wall of he crown because it is a generally tubular structure that is hollow and that is the natural state it would assume when compressed from two sides, such as by an infant’s mouth.
Regarding claim 11, while Conner substantially discloses the invention as claimed, it does not disclose the nipple shield has a first thickness along a first portion and a second thickness along a second portion adjacent to the first portion and wherein the second thickness is less than the first thickness.
Scheuerle discloses different sections to allow the device to mimic-mouth fell or a thicker portion to provide structural integrity (¶135).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Conner such that the nipple shield has a first thickness along a first portion and a second thickness along a second portion adjacent to the first portion and wherein the second thickness is less than the first thickness as taught by Scheuerle to provide a desired texture in one portion and a structural integrity in the other portion.
Note with respect to claim 11, the examiner did not find claim 11 as part of the initial search if the first and second portions were along the same cross-section (if taken looking down at the device laying flat, similar to Applicant fig 5C)
Regarding claim 12, wherein the nipple shield defines an indicator corresponding to a location of the channel, and wherein the indicator helps to orient the device when the device is in use (fig 11, location where 132 meets 124 indicates an orientation of the device).
Regarding claim 13 wherein the outer wall of the crown defines a plurality of additional channels (fig 11, four in total).
Regarding claim 14 further comprising a circumferential seal configured for placement around the crown for contacting a skin of the subject (unlabeled in fig 11, 106 in fig 2).
Regarding claim 16, wherein the breastfeeding aid device is further configured to form a negative pressure within the at least one fluid lumen when the suction force is applied (fig 12B; ¶53).
While Conner substantially discloses the invention as claimed, it does not disclose the at least one fluid lumen is configured to collapse upon application of the negative pressure.
Scheuerle discloses the nipple shield (including the crown) is made of a flexible and/or elastic material to easily conform to the shape of the breast of the wearer (¶26). Further, the area which is placed in the infant’s mouth facilitates force transfer and a normal mouth-feel in the oral cavity (¶135; which includes slight collapse of the nipple). Also in ¶135, Scheuerle discloses the section of the device adjacent the breast is desired to be thicker to give it structural integrity (suggesting the other section lacks at least a bit of structural integrity)
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Conner such that the crown is made of a flexible and/or elastic material (which is configured to collapse due to lower pressure caused by vacuum and higher pressure of infant’s mouth) as taught by Scheuerle to easily conform to the shape of the breast of the wearer and to mimic a normal mouth-feel for the infant.
Regarding claim 27, further comprising two or more openings defined in a top surface of the crown (fig 11), wherein a first opening of the two or more openings provides access to the cavity and a second opening of the two or more openings provides access to the channel (fig 12B, both/all four openings provide access to both the cavity and the channel).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conner et al (US 2016/0120763) in view of Scheuerle et al (US 2020/0206083) and Frisch et al (US 12,029,705).
Regarding claim 2, while Conner substantially discloses the invention as claimed, it does not disclose a valve positioned within a second opening of the reservoir, wherein the valve is configured to allow for a unidirectional flow of air into the reservoir.
Frisch discloses a one-way air intake valve 16 (Col.2 ll 57-58) in a different opening from the reservoir exit. This allows air to enter the reservoir during feeding to maintain proper flow of liquid (Col.2 ll 53-56).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Conner such that it includes a valve positioned within a second opening of the reservoir, wherein the valve is configured to allow for a unidirectional flow of air into the reservoir as taught by Frisch to maintain proper flow of liquid out of the device.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conner et al (US 2016/0120763) in view of Scheuerle et al (US 2020/0206083) and Krammer (US 2,680,441).
Regarding claim 6, while Conner substantially discloses the invention as claimed, it does not disclose the reservoir defines a plurality of gradations for indicating fluid volume.
Krammer discloses a syringe 5 for providing medication as part of a milk delivery system. The syringe has a plurality of graduations (fig 1).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Conner such that the reservoir defines a plurality of graduations for indicating fluid volume as taught by Krammer to allow a user to determine both how much medication has bene delivered and how much remains.
Claim(s) 7, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conner et al (US 2016/0120763) in view of Scheuerle et al (US 2020/0206083) and Nordquist et al (US 2016/0067148).
Regarding claim 7, while Conner substantially discloses the invention as claimed, it does not disclose an adjustable clamping mechanism positioned along the at least one fluid lumen for metering a flow of fluid through the at least one fluid lumen.
Nordquist discloses a feeding system for infants, including use with milk (¶48, figs 2A-2C) which uses a roller clamp 222 (which is an adjustable clamping mechanism) to selectively and adjustably prevent, limit and/or meter the rate of flow of contents from the reservoir to the child (¶56).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Conner such that it includes an adjustable clamping mechanism positioned along the at least one fluid lumen for metering a flow of fluid through the at least one fluid lumen as taught by Nordquist to selectively and adjustably prevent, limit and/or meter the rate of flow of contents from the reservoir.
Regarding claims 17 and 18, while Conner substantially discloses the invention as claimed, it does not disclose the flow selector defines one or more openings through a body of the flow selector, and wherein each of the one or more openings have a diameter different from one another, nor a selector coupling defining a selector coupling cavity and a flow opening, wherein the selector coupling is coupled to the first opening and the flow selector is positioned within the selector coupling cavity and configured to receive the flow selector, and wherein the one or more openings are selectively aligned with the flow opening to achieve the predetermined flow rate in an alignment corresponding to the one or more openings.
Nordquist discloses a feeding system for infants, including use with milk (¶48, figs 2A-2C) which uses a roller clamp 222 (which is an adjustable clamping mechanism) to selectively and adjustably prevent, limit and/or meter the rate of flow of contents from the reservoir to the child (¶56). The flow selector of Nordquist defines one opening through a body of the flow selector (main lument), and wherein each of the one opening has a diameter different from one another (depending on the position of roller), and a selector coupling defining a selector coupling cavity (cavity in which tube and roller are located) and a flow opening (from which tube exits), wherein the selector coupling is coupled to the first opening and the flow selector is positioned within the selector coupling cavity and configured to receive the flow selector (fig 2B of Norquist), and wherein the opening is selectively aligned with the flow opening to achieve the predetermined flow rate in an alignment corresponding to the one opening.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conner et al (US 2016/0120763) in view of Scheuerle et al (US 2020/0206083) and Morrow (US 11,206,875).
Regarding claim 15, while Conner substantially discloses the invention as claimed, it does not disclose an adhesive layer coupled to the nipple shield, wherein the adhesive layer surrounds the crown.
Morrow discloses an adhesive layer 11 coupled to the nipple shield, wherein the adhesive layer surrounds the crown (fig 4). This assists is securing a nipple shield to a breast.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Conner such that it includes an adhesive layer coupled to the nipple shield, wherein the adhesive layer surrounds the crown as taught by Morrow to provide an additional means to secure the nipple shield to the breast (especially where suction/friction is not sufficient).
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