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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/05/2026 has been entered.
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, 3, 5, 9, 17, 20 and all claims depending therefrom 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 claim 1, the limitation "the lower cover surface adapted to be attached to the upper surface of the base unit to define a channel passageway within the channel cover" is indefinite. Since the channel passageway has been amended to be defined as already present "within the channel cover", it would appear to be present regardless of whether the lower cover surface were attached to the upper surface of the base unit; therefore, it is not known what specific structure defines the channel passageway by the attachment of the lower cover surface to the upper surface of the base unit. Claim 17 recites a similar limitation, and is rejected for the same reason.
Further, regarding claim 1, the limitation "a loop that extends to a remote location to at least one outlet opening in the upper cover surface of the channel cover to a mouth of the infant" is unclear because it is not known whether the "remote location" is the "outlet opening", or whether the outlet opening extends beyond the remote location, or whether the remote location extends beyond the outlet opening.
Regarding claims 1 and 17, the meaning of the limitation "a channel cover separate from the base unit" is indefinite for the reasons set forth below.
Specifically, it is unclear whether "separate" requires the channel cover to be physically detached from the base unit, or merely indicates that the channel cover and base unit are distinct, non-integral components.
Both claims recite, in their preambles, "A nipple shield adapted to provide a visual indication of a milk flow from a breast to an infant during nursing"; this use per se requires the channel cover and base unit to be assembled together in order to form the claimed "channel passageway within the channel cover" through which the visual indication of milk flow is provided.
Therefore, it is unclear how the base unit and channel cover could be "separate" and still permit the inventions to perform their claimed functions.
The ambiguity is further evidenced by dependent claims 3-5 and 20, which recite embodiments in which the channel cover is attached, permanently fixed, or permanently integrated with the base unit, as follows.
Claim 3 recites "portions of the lower cover surface of the channel cover are attached to the upper surface of the base unit", while claim 4 covers an attachment structure that "permanently fixes the lower cover surface of the channel cover to the upper surface of the base unit.". It is not clear how the channel cover could be both "separate from the base unit" according to claim 1, and "attached to" the base unit according to claim 3.
Claim 5 recites "the channel cover is permanently attached to the base unit by a plasma treatment process to define a permanently integrated nipple shield", and so it is not clear how the channel cover could be both "separate from the base unit" according to claim 1, and "permanently attached to the base unit" in claim 5.
Regarding claim 9, the limitation “all of the milk flow from the inlet opening in the single channel passageway can be visually observed in the single channel passageway at the remote location within the wide base” lacks antecedent basis for the limitation “the single channel passageway at the remote location within the wide base”. The claimed invention does not appear to have previously recited that any part of the single channel passageway is located at the remote location. Instead, the claim recites that the single channel passageway “extends from the inlet opening through a loop to a remote location”. The claimed invention can also be reasonably interpreted to mean a single channel passageway that includes a loop, or alternatively, a single channel passageway traversing a loop that is not part of the passageway itself.
Claim 20 covers a structure of "base unit and the channel cover … constructed as separate parts" but which are permanently fixed to one another. It is not clear how the channel cover could be both "separate from the base unit" according to claim 1, and "attached to" the base unit according to claim 3.
For the purpose of examination, the above-mentioned limitations, in claims 1 and 17, will be interpreted to mean a channel cover distinct from the base unit.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phillips et al (U.S. Pat. 10,220,126 B2, hereinafter “Phillips”).
Regarding claim 1, Phillips discloses a flexible device, i.e., a breast shield 200 (see Fig. 2 and col. 5, lines 33-35 disclosing that the shield 200 can be made from “silicone, urethane, polypropylene, or another flexible food-grade material”) adapted to provide a visual indication of a milk flow from a breast to an infant during nursing (see below for an explanation of this feature), the flexible device comprising:
a base unit (combination of interior portion 6 and chamber 8; see Figs. 2-7) having an upper surface (the exterior surface of the base unit contacting the channel cover 2) and a lower surface (the surface of the base unit contacting the breast), the base unit having a protrusion (defined by the interior portion 6) disposed in a central region adapted to be positioned over a nipple of the breast, wherein the lower surface of the base unit is adapted to lie securely against the breast (see col. 11, lines 40-41); and
a channel cover 2 (see Figs. 2-7) separate from the base unit (i.e., the cover 2 is distinct from base unit 6 and 8) and having an upper cover surface (exterior portion; see Fig. 3) and a lower cover surface (the surface contacting the base unit), the lower cover surface adapted to be attached to the upper surface of the base unit to define a channel passageway within the channel cover (combination of 10, 12 and 14; see Fig. 3) that fluidly connects at least one inlet opening in the lower surface of the base unit (i.e., the inlet opening in the lower surface of the base unit is the opening into the interior portion 6 allowing milk to flow from the breast into the interior portion 6), through a loop that extends to a remote location, to at least one outlet opening 14 (see Fig. 3) in the upper cover surface of the channel cover (interpreted to mean the inlet opening connects to the mouth of the infant via the loop that extends to a remote location and the at least one outlet opening; Phillips discloses that milk flows from the interior portion 6, through the chamber 8 and to a remote location in reservoir 10, and then loops back through channel 12 to the outlet opening 14 and into the mouth of the infant);
wherein the channel passageway extends from the protrusion (defined by the interior portion 6) to the remote location (i.e., to the reservoir 10), so that the milk flow in the channel passageway within the channel cover can be visually observed when a mouth of the infant covers at least one of the inlet opening or outlet opening of the needle shield (see col. 9, lines 29-31; liquid can be visually perceived to be flowing through the loop described above even if the mouth of the infant covers the outlet opening).
Claims 1-8, 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melamed (U.S. Pat. 10,912,511 B2, hereinafter “Melamed”).
Regarding claim 1, Melamed discloses a flexible device 100 adapted to provide a visual indication of a milk flow from a breast to an infant during nursing (see below for an explanation of this feature), the flexible device comprising:
a base unit (see Fig. 4, annotation 1, below) having an upper surface (see Fig. 4, annotation 1, below) and a lower surface 11 (see Fig. 4), the base unit having a protrusion (defining inlet space 16; see Fig. 4) disposed in a central region adapted to be positioned over a nipple of the breast, wherein the lower surface of the base unit is adapted to lie securely against the breast (as shown in Fig. 4) and
a channel cover separate from the base unit (see Fig. 4, annotation 1, below showing the channel cover and base unit delineated by dotted lines, the two structures being distinct) having an upper cover surface (see Fig. 4, annotation 1, below) and a lower cover surface (see Fig. 4, annotation 1, below), the lower cover surface adapted to be attached to the upper surface of the base unit to define a channel passageway 20 within the channel cover (see Fig. 4) that fluidly connects at least one inlet opening 18 (see Fig. 4) in the lower surface of the base unit through a loop that extends to a remote location, and back to at least one outlet opening 24 (see Fig. 4) in the upper cover surface of the channel cover (interpreted to mean the inlet opening connects to the mouth of the infant via the loop that extends to a remote location and the at least one outlet opening; Melamed discloses that milk flows from the inlet opening 18, through channel passageway 20 to a remote location near a measurement unit 26, and then loops back through channel 22 to the outlet opening 24 and into the mouth of the infant);
wherein the channel passageway 20 extends from the protrusion to the remote location (such as a measurement unit 26; see Fig. 3) so that the milk flow in the channel passageway within the channel cover can be visually observed when a mouth of the infant covers a portion of the flexible device (milk flows from the channel passageway into the measurement unit, which has a window 44 enabling visual observation of the milk flowing through the measurement unit; therefore the window permits observation of milk that was in the channel passageway).
PNG
media_image1.png
650
993
media_image1.png
Greyscale
Melamed, Fig. 4, annotation 1.
Regarding claim 2, Melamed discloses that the at least one inlet opening and at least one outlet opening is disposed adjacent to an apex in the protrusion (see Fig. 4 showing both openings 18 and 24 being roughly in line with the apex of the protrusion).
Regarding claims 3 and 4, the limitations reciting how portions of the lower cover surface of the channel cover are attached to the upper surface of the base unit, i.e., by a “plasma treatment process” to define the channel passageway recite a product by process limitation.
It has been held that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
In this case, the structure implied by the process steps does not impart distinctive structural characteristics to the final product. The two units are attached, as shown in Fig. 4, to form the channel passageway 20.
Regarding claim 5, limitation reciting that “the channel cover is permanently attached to the base unit by a plasma treatment process to define a permanently integrated nipple shield” recites a product-by-process limitation (see above for an explanation of how these limitations are treated for the purpose of examination).
In this case, the structure implied by the process steps does not impart distinctive structural characteristics to the final product. The channel cover is permanently attached to the base unit, and as such, defines a permanently integrated nipple shield, as shown in Fig. 4.
Regarding claim 6, Melamed discloses an assembly comprising:
the flexible device recited in claim 1, and
an electronic connector, such as an electronic measurement unit 26 (see col. 13, lines 25-32), to detect a characteristic in the milk flow such as flow rate, volume or mass of milk flow (see col. 13, lines 25-42).
Regarding claim 7, Melamed discloses that the electronic connector evaluates the detected characteristic and returns an output (i.e., the connector evaluates an electronic signal to indicate a flow rate, volume or mass of milk flow).
Regarding claim 8, Melamed discloses that the electronic connector communicates the detected characteristic to a remote processor to evaluate the detected characteristic and to return an output (see col. 11, lines 53 to col.12, line 4 disclosing how the connector communicates the signal indicative of the measured quantity, i.e., flow rate, volume or mass, to processing unit that can store such data on a local or remote data storage device).
Regarding claim 17, Melamed discloses a nipple shield 100 adapted to provide a visual indication of a milk flow from a breast to an infant during nursing (see below for an explanation of this feature), the flexible device comprising:
a base unit (see Fig. 4, annotation 1, above) having an upper surface (see Fig. 4, annotation 1, below) and a lower surface 11 (see Fig. 4), the base unit having a protrusion (defining inlet space 16; see Fig. 4) disposed in a central region adapted to be positioned over a nipple of the breast, wherein the lower surface of the base unit is adapted to lie securely against the breast (as shown in Fig. 4) and
a channel cover separate from the base unit (see Fig. 4, annotation 1, below showing the channel cover and base unit delineated by dotted lines, the two structures being distinct) having an upper cover surface (see Fig. 4, annotation 1, below) and a lower cover surface (see Fig. 4, annotation 1, below), the lower cover surface adapted to be attached to the upper surface of the base unit to define a channel passageway 20 within the channel cover (see Fig. 4) that fluidly connects at least one inlet opening 18 (see Fig. 4) in the lower surface of the base unit through a loop that extends to a remote location (such as a measurement unit 26; see Fig. 3) to at least one outlet opening 24 (see Fig. 4) in the upper cover surface of the channel cover (the limitations covering how the lower cover surface is adapted to be attached to the upper surface of the base unit, i.e., by a plasma treatment process, are considered to be intended use and a product-by-process limitation that does not impart a distinctive characteristic on the final product), and
wherein the channel passageway 20 extends from the inlet opening in the protrusion and outward to the remote location (such as a measurement unit 26; see Fig. 3) and then back to the outlet opening 26 in the protrusion (via the outlet conduit 22; see Fig. 4) such that the milk flow in the channel passageway can be visually observed in the remote location when a mouth of the infant covers at least one of the inlet or outlet openings of the nipple shield (the measurement unit comprises a window 44 enabling visual observation of the milk flowing through the measurement unit even when the inlet and/or outlet openings are covered by an infant’s mouth).
Regarding claim 19, Melamed discloses that the at least one inlet opening and the at least one outlet opening are disposed adjacent to an apex in the protrusion.
Regarding claim 20, the following limitations are product-by-process limitations:
“the base unit and the channel cover are constructed as separate parts, and wherein the plasma treatment process is applied to:
chemically remove contaminants from an upper surface of the base unit and a lower cover surface of the channel cover; and
highly energize the upper surface of the base unit and a lower cover surface of the channel cover;
wherein when the lower surface of the channel cover is aligned with and placed adjacent to the upper surface of the base unit, the two surfaces chemically interact together forming strong permanent covalent bonds between the surfaces.”
See above for an explanation of how these limitations are treated for the purpose of examination.
In this case, the structure implied by the process steps does not impart distinctive structural characteristics to the final product. Because the final product is a nipple shield with the two surfaces “chemically interact[ing] together forming strong covalent bonds between” them, the processes covering the steps of assembly prior to putting the assembly together do not appear to change the structural characteristics of the final product.
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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Melamed in view of Conner et al (U.S. Pub. 2016/0120763 A1, hereinafter “Conner”).
Regarding claim 18, it is noted that Melamed disclose that the nipple shield is a silicone material (see col. 11, lines 45-46), but does not disclose that the silicone material is transparent.
Conner discloses a nipple shield for visually observing the flow of milk from a breast to an infant during nursing, comprising a material, such as silicone, that is preferably transparent (see para [0035]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Melamed, in order to make the nipple shield transparent, in doing permitting the fluid to be seen without removing the nipple shield form the breast, with a reasonable expectation of success.
Allowable Subject Matter
Claims 9-16 are objected to as being dependent upon a rejected base claim, but would be allowable pending overcoming the rejections under 35 U.S.C. 112(b), and rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 09/02/2025 have been fully considered.
Rejections under 35 U.S.C. 112(b)
Applicant argued that edits have addressed the rejections (see Remarks, pg. 8). Applicant’s amendments have overcome those rejections; Examiner notes that new grounds of rejection under 35 U.S.C. 112(b), necessitated by the claim amendments, have been applied to claims 1, 3, 5, 17, 20 and all claims depending therefrom.
Rejections under 35 U.S.C. 102(a)(1) as being anticipated by Phillips
Applicant argued that Phillips fails to disclose a channel cover "separate from the base unit" base unit (see Remarks, pg. 9). This argument is not persuasive; see rejection, above, for a discussion of the meaning of the word "separate" in this context.
Rejections under 35 U.S.C. 102(a)(1) as being anticipated by Melamed
Applicant argued that Melamed fails to disclose a base unit (Applicant argued that Melamed fails to disclose a channel cover "separate from the base unit" base unit (see Remarks, pg. 9). This argument is not persuasive; see rejection, above, for a discussion of the meaning of the word "separate" in this context.
Rejections under 35 U.S.C. 103 as being obvious over Melamed in view of Conner
Applicant argued that Conner does not cure the deficiencies of Melamed, but no other arguments were made with respect to the specific teachings of Conner. The rejection is maintained for the reasons described above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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.
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
06/08/2026
Prosecution Insights