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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 05/12/2023, has been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “pump”, “connection interface”, “controller”, “removable cover”, “fixed transparent cover”, and “lens” (as recited in claims 1, 7-9, and 15) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Figures 1-3 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim recites the limitation of “the breast” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation. The limitation should be corrected to recite “a breast.” Appropriate correction is required.
Claim 1 is objected to because of the following informalities: The claim recites the limitation of “the end” in the 4th line of the claim. There is a lack of antecedent basis for this limitation. The limitation should be corrected to recite “an end.” Appropriate correction is required.
Claim 1 is objected to because of the following informalities: The claim recites the limitation of “the user” in the 9th line of the claim. There is a lack of antecedent basis for this limitation. The limitation should be corrected to recite “a user.” Appropriate correction is required.
Claim 5 is objected to because of the following informalities: The claim recites the limitation of “the nipple” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation. The limitation should be corrected to recite “a nipple.” Appropriate correction is required.
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 1-15 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.
[Claims 1-3] The claims recite the limitations of “directly in front.” The examiner is unable to determine the metes and bounds of the claims, since the recited “front” has not been defined. Further, the claims provide no relative orientation of the structures to each other or their relative orientations/positions in space. As such, for purposes of examination, it is interpreted that the “front” of the apparatus is not specific to any particular surface.
[Claims 2 and 3] The claims recite the limitation of “a cone formed by an angle” “all around the view from directly in front.” Again, the examiner is unable to determine the metes and bounds of the claim, since it is unclear what “views” are encompassed by these limitations. Again, the claims provide no relative orientation of the structures to each other or their relative orientations/positions in space. For purposes of examination, it is interpreted that any “view” of the “nipple-receiving portion” which is “blocked” meets the limitations of the claims.
[Claim 3] Regarding claim 3, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
[Claim 5] The claim recites the limitation of “the components” in the 1st and 2nd lines of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claims, since it is unclear exactly which structures this limitation is meant to encompass. For purposes of examination, it is interpreted that “the components” only refers to the “window” and the “nipple-receiving portion.”
[Claim 5] The claim recites the limitation of “the line of sight” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claims, since it is unclear if this refers to the previously recited “direct line of sight,” or if a new limitation is being introduced into the claim limitations. For purposes of examination, it is interpreted that the limitation refers to the previously recited “direct line of sight.”
[Claim 5] The claim recites the limitation of “the nipple portion” in the 2nd and 3rd lines of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claims, since it is unclear if this refers to the previously recited “nipple-receiving portion,” or if a new limitation is being introduced into the claim limitations. For purposes of examination, it is interpreted that the limitation refers to the previously recited “nipple-receiving portion.”
[Claim 12] The claim recites the limitation of “The breast pump of claim 1, comprising a wearable breast pump.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the limitation is reciting a functionality or if an additional structure is being introduced into the claim limitations. For purposes of examination, it is interpreted that a functionality is being claimed, such that the limitation should recite “The breast pump of claim 1, wherein the breast pump is configured to be worn by the user.”
[Claims 2-15] The claims are rejected based upon their dependency from independent claim 1.
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)(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.
Claims 1-6, 8, and 10-15, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Makower et al. (PGPub 2023/0117214).
[Claims 1, 4, 10, 12, and 14] Makower teaches a wearable breast pump (figure 43, item 100; paragraphs [0004], [0223]) comprising:
an outer housing (figure 43, item 34) for mounting over a breast (as best shown in figure 27b);
a breast shield (figure 43, item 10) removably received (coupled together) in the outer housing (figure 43, item 34) as a single unit (paragraph [0223]), comprising a transparent nipple-receiving portion (figure 43, near item 54) at an end of a breast-receiving portion (figure 43, distal portion of item 10);
a pump (figure 43, items 36/38; “compression elements”; paragraph [0226]);
a connection interface (figure 43, item 62; paragraph [0165]) for connection to a milk container (figure 43, item 60; paragraph [0161]); and
a controller (figure 43, item 52) for implementing a cyclic pressure waveform to the breast shield (figure 43, item 10) (paragraph [0146]),
wherein the outer housing (figure 43, item 34) has a window (figure 43, items 432/434) in an upper portion (the examiner notes the orientation of the structure has not been defined) of the outer housing (figure 43, item 34), for enabling, in use, a direct line of sight (figure 43; paragraph [0223]) for a user of the breast pump (figure 43, item 100), through the window (figure 43, items 432/434) to the nipple-receiving portion (figure 43, near item 54) of the breast shield (figure 43, item 10),
and wherein the outer housing (figure 43, item 34) blocks a view of the nipple-receiving portion (figure 43, near item 54) from at least directly in front (see 112b interpretation above) to prevent visibility to third parties (figure 43; paragraph [0223]).
[Claims 2 and 3] Makower teaches the limitations of claim 1, upon which claims 2 and 3 depend. In addition, Makower discloses a view of the nipple-receiving portion (figure 43, near item 54) is blocked for a range of view directions including from directly in front (see 112b interpretation above) and a cone formed by an angle (see 112b interpretation above) of at least 20 degrees, for example (see 112b interpretation above) an angle of at least 30 degrees, for example (see 112b interpretation above) an angle of at least 40 degrees, all around the view from directly in front (see 112b interpretation above) (figure 43; paragraph [0223]).
[Claim 5] Makower teaches the limitations of claim 1, upon which claim 5 depends. Makower also teaches the components (see 112b interpretation above) along the line of sight (see 112b interpretation above) to a nipple of the user include the window (figure 43, items 432/434) and the nipple portion (see 112b interpretation above) (figure 43, near item 54) of the breast shield (figure 43, item 10) (figure 43; paragraph [0223]).
[Claims 6 and 8] Makower teaches the limitations of claim 1, upon which claims 6 and 8 depend. Makower further discloses the window (figure 43, items 432/434) comprises an opening (figure 43, item 432) in the outer housing (figure 43, item 34) having a fixed transparent cover (figure 43, item 434) (figure 43; paragraph [0223]).
[Claim 11] Makower teaches the limitations of claim 1, upon which claim 11 depends. In addition, Makower discloses an illumination source (“a light may be provided underneath one or more of the controls 252 or where the milk tube 32 exits the main body 34.”; or figure 44a, item 440 “light source”) for illuminating a space inside the nipple-receiving portion (figure 43, near item 54) (paragraphs [0162], [0224]).
[Claim 13] Makower teaches the limitations of claim 1, upon which claim 13 depends. Makower also teaches the controller (figure 43, item 52) is adapted to implement at least two operating modes comprising a stimulation mode and an extraction mode, with different cyclic frequency and different maximum under-pressure levels (“controller 52 may be electrically connected to the drivers 44, 46 and may be configured to modify the operation of the compression elements 36, 38 based on input received from an optional pressure sensor 54 (or multiple pressure sensors) that may be placed at least one location to assess the pumping function and maintain an acceptable pumping negative pressure profile for a wide variety of milk expression volumes”) (the examiner notes any modification would involve “different” frequencies and pressures, thus could define the claimed “modes”) (paragraphs [0143], [0145], [0146]).
[Claim 15] Makower teaches the limitations of claim 14, upon which claim 15 depends. Makower further discloses the milk container (figure 43, item 60) is attachable (via connection interface 62) to a base (any connection point could be considered the “base”) of the outer housing (figure 43, item 34), and the pump (figure 43, items 36/38) is within the outer housing (figure 43, item 34) (figure 43).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Makower et al. (PGPub 2023/0117214), in view of Myers (PGPub 2011/0245763).
[Claim 7] Makower teaches the limitations of claim 6, upon which claim 7 depends. Makower does not specifically disclose a removable cover over the opening.
However, Myers teaches a breast pump (figure 23, item 10), wherein an outer housing (figure 23, item 16) comprises an opening having a removable cover (figure 23, item 65) (paragraphs [0052], [0065], [0069]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified structure taught by Makower, with the use of a removable cover over the opening, as taught by Myers, in order to provide increased functionality and control, by allowing for a means by which a user might maintain complete privacy by preventing any visibility of the nipple-receiving portion of the breast shield.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Makower et al. (PGPub 2023/0117214), in view of Hung et al. (WO 00/29044 A2).
[Claim 9] Makower teaches the limitations of claim 6, upon which claim 9 depends. Makower does not specifically disclose a lens within or over the opening.
However, Hung teaches a breast pump (figure1, item 1) comprising a lens (figure 1, item 2) within an opening (figure 1, item 8) of an outer housing (not labeled) (figure 1) (page 14, lines 27-31).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified structure taught by Makower, with the use of a lens within or over the opening, as taught by Hung, in order to provide increased functionality and control, by allowing for a means by which a user might more easily view the nipple-receiving portion of the breast shield.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 11/24/2025