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 4-6, 8, 14-16 and 18 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.
Regarding claims 4-6, 8, 14-16 and 18 the recitations of “superior”, “inferior”, “posterior”, and “anterior” are indefinite, because they are not related to any other element or frame of reference. One of skill in the art is not apprised of what positions would or would not meet the claim limitations.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0242213 to McCarty et al. (McCarty hereinafter) in view of US Pre-Grant Publication 2015/0038945 to McCabe (McCabe).
Regarding claim 1, McCarty teaches a system including a chamber (vessel 40) that stores feeding fluid (nutritive fluid 43) (paragraph 54), a dosing mechanism (peristaltic pump 67/pinch valve 167) that receives feeding fluid (nutritive fluid 43) from the chamber (vessel 40), and dispenses discrete packets of feeding fluid (nutritive fluid 43) (paragraph 40), each discrete packet having a discrete packet volume (paragraph 40), a feeding apparatus (nipple 98) that receives feeding fluid (nutritive fluid 43) dispensed by the dosing mechanism (peristaltic pump 67/pinch valve 167) and that allows feeding fluid (nutritive fluid 43) to flow to the individual's mouth (infant’s mouth; paragraph 54) through an outlet (outlet 486) of the feeding apparatus (nipple 98) (paragraph 40), a collapsible chamber (63, 66, 97), and a sensor assembly (sensor 490) that determines when the feeding apparatus (nipple 98) is available to receive a new discrete packet of feeding fluid (nutritive fluid 43) dispensed from the dosing mechanism (peristaltic pump 67/pinch valve 167) (paragraph 40). The examiner notes that this system is configured to store room or body temperature liquid in the chamber, and as such is configured to store expressed breastmilk. McCarty does not teach a negative pressure source configured to express breastmilk from a breast. McCabe teaches another infant feeding system generally, and particularly teaches that a negative pressure source (80) is provided in order to express the breastmilk and channel it into a container (via 60). Moreover, McCabe teaches that the use of breastmilk is advantageous (paragraph 3). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a breast pump (80), collector (86), and channel tubing (60) as taught by McCabe in order to collect breast milk for use in the system of McCarty. The examiner notes that the tubing of McCabe could easily and simply be arranged to empty into the chamber (40) of McCarty in order to have the system pump breast milk instead of formula.
Regarding claim 2, McCarty does not teach a check valve disposed as claimed. However, McCabe indicates the general cognizance of check valves in the art (see e.g. paragraph 14) for establishing a single direction of flow. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a check valve disposed as claimed in order to establish a one-way flow of fluid to the nipple.
Regarding claim 3, McCarty teaches a counting mechanism (other elements of the processor; paragraph 60) that registers a count (pump rotations corresponding to a dispensing event) for each dispensing event performed by the dosing mechanism (peristaltic pump 67/pinch valve 167) (paragraph 60).
Regarding claims 4-6, McCabe teaches a breast flange (88) defining a breast flange axis. As best understood by the examiner, the feeding apparatus or pump of McCarty teaches any number of possible axes, some and the present combination does not require any particular orientation of the breast flange relative to the feeding apparatus. Accordingly, the positional relationship of the two axes and elements is at most a functional limitation which may be met by, for instance, moving the flange of McCabe relative to the feeing apparatus of McCarty. Furthermore, McCarty teaches a housing (46).
Regarding claim 7, McCarty teaches that the chamber (40) is removable from the housing (see at least, Fig. 1a, in which chamber is shown as separate from the holder).
Regarding claim 8, McCarty teaches a peristaltic pump (67). As best understood by the examiner, the positional relationship is a functional limitation which the combined apparatus is capable of performing.
Regarding claim 9, McCarty teaches that the dosing mechanism (peristaltic pump 67/pinch valve 167) comprises a gate (pinch valve 167) and a tube (on tube segment 166), wherein the sensor assembly (sensor 490) comprises a full sensor (sensor options in paragraph 55) and an empty sensor (air detection sensor 171), wherein the gate allows passage of feeding fluid through the tube when the empty sensor indicates the tube is empty of feeding fluid (paragraphs 11 and 42), and wherein the gate (pinch valve 167) prevents passage of feeding fluid (nutritive fluid 43) through the tube (tube segment 166) when the full sensor (sensor options in paragraph 55) indicates the tube is full of feeding fluid (paragraphs 42-43, 51, 55 and 61).
Regarding claim 10, McCarty teaches that the sensor assembly (sensor 490) comprises a hall effect sensor (paragraph 55), and wherein the system further comprises: a collapsible chamber (63, 66, 97) that receives the discrete packets of feeding fluid dispensed by dosing mechanism (peristaltic pump 67) and that allows the discrete packets of feeding fluid to flow toward the outlet (outlet 486) of the feeding apparatus (nipple 98); and a magnet (hall effect sensor comprises a magnet; paragraph 55) in operative association with the collapsible chamber (membrane external surface 477) (paragraph 55), wherein the sensor assembly (sensor 490) determines that the peristaltic pump (peristaltic pump 67) should dispense the new discrete packet of feeding fluid (nutritive fluid 43) when the magnet reaches a first distance away from the hall effect sensor and that the peristaltic pump should pause when the magnet reaches a Application No.: 17/554,746Confirmation No.: 1355Docket No.: 0038-0001 IOUSRESPONSE TO RESTRICTION REQUIREMENTPage 3second distance away from the hall effect sensor, the first distance being greater than the second distance (paragraph 55).
Regarding claim 11, the combined references teach the method including the structure as discussed above with respect to claim 1. McCabe teaches contacting the flange with a breast (paragraph 25) and expressing breastmilk. McCarty teaches storing liquid in the chamber (40), receiving the liquid at a dosing mechanism (peristaltic pump 67/pinch valve 167), dispensing discrete packet volumes (paragraph 40), allowing the packets to flow into a nipple interior (paragraphs 40, 54), and determining, with a sensor assembly (sensor 490), when the feeding apparatus (nipple 98) is available to receive a new discrete packet of feeding fluid (nutritive fluid 43) dispensed from the dosing mechanism (peristaltic pump 67/pinch valve 167) (paragraph 40).
Regarding claim 12, McCarty does not teach a check valve disposed as claimed. However, McCabe indicates the general cognizance of check valves in the art (see e.g. paragraph 14) for establishing a single direction of flow. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a check valve disposed as claimed in order to establish a one-way flow of fluid to the nipple.
Regarding claim 13, registering, with a counting mechanism (other elements of the processor; paragraph 60), a count (pump rotations corresponding to a dispensing event) for each dispensing event performed by the dosing mechanism (peristaltic pump 67/pinch valve 167) (paragraph 60).
Regarding claims 14-16, McCabe teaches a breast flange (88) defining a breast flange axis and its engagement with the breast (paragraph 25). As best understood by the examiner, the feeding apparatus or pump of McCarty teaches any number of possible axes, some and the present combination does not require any particular orientation of the breast flange relative to the feeding apparatus. Accordingly, the positional relationship of the two axes and elements is at most a functional limitation which may be met by, for instance, moving the flange of McCabe relative to the feeing apparatus of McCarty. Furthermore, McCarty teaches a housing (46).
Regarding claim 17, McCarty teaches that the chamber (40) is removable from the housing (see at least, Fig. 1a, in which chamber is shown as separate from the holder).
Regarding claim 18, McCarty teaches a peristaltic pump (67). As best understood by the examiner, the positional relationship is a functional limitation which the combined apparatus is capable of performing.
Regarding claim 19, McCarty teaches that the dosing mechanism (peristaltic pump 67/pinch valve 167) comprises a gate (pinch valve 167) and a tube (on tube segment 166), wherein the sensor assembly (sensor 490) comprises a full sensor (sensor options in paragraph 55) and an empty sensor (air detection sensor 171), wherein the gate allows passage of feeding fluid through the tube when the empty sensor indicates the tube is empty of feeding fluid (paragraphs 11 and 42), and wherein the gate (pinch valve 167) prevents passage of feeding fluid (nutritive fluid 43) through the tube (tube segment 166) when the full sensor (sensor options in paragraph 55) indicates the tube is full of feeding fluid (paragraphs 42-43, 51, 55 and 61).
Regarding claim 20, McCarty teaches that the sensor assembly (sensor 490) comprises a hall effect sensor (paragraph 55), and wherein the system further comprises: a collapsible chamber (63, 66, 97) that receives the discrete packets of feeding fluid dispensed by dosing mechanism (peristaltic pump 67) and that allows the discrete packets of feeding fluid to flow toward the outlet (outlet 486) of the feeding apparatus (nipple 98); and a magnet (hall effect sensor comprises a magnet; paragraph 55) in operative association with the collapsible chamber (membrane external surface 477) (paragraph 55), wherein the sensor assembly (sensor 490) determines that the peristaltic pump (peristaltic pump 67) should dispense the new discrete packet of feeding fluid (nutritive fluid 43) when the magnet reaches a first distance away from the hall effect sensor and that the peristaltic pump should pause when the magnet reaches a Application No.: 17/554,746Confirmation No.: 1355Docket No.: 0038-0001 IOUSRESPONSE TO RESTRICTION REQUIREMENTPage 3second distance away from the hall effect sensor, the first distance being greater than the second distance (paragraph 55).
Response to Arguments
Applicant's arguments filed 20 November 2026 have been fully considered but they are not persuasive.
With respect to the argument that McCarty does not teach a collapsible chamber, the examiner is partially persuaded. The examiner has therefore changed the mapping of the collapsible chamber as shown in bold above. The flexible tube is a liquid holding chamber which is capable of being collapsed under pressure and from which the liquid flows into the nipple interior. Accordingly, the examiner does not agree that McCarty lacks the limitation.
With respect to the positional limitations, the examiner notes that the relevant axes are not defined relative to any claimed structure, nor is the upright orientation. Similarly, a user of the system need not be sitting or standing or in any other particular position. Accordingly, the examiner cannot grant any patentable weight under the broadest reasonable interpretation of the claims to the positional limitations as currently recited.
Conclusion
THIS ACTION IS MADE FINAL. 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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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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.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 10 March 2026