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 statements (IDS), submitted on 05/11/2023 and 07/18/2024, have been considered by the examiner.
The examiner notes the attached IDS, dated 5/11/2023, has been annotated to correct the cited Foreign Patent document (WO-2018229504). It is further noted that the document has been correctly cited in the IDS filed on 07/18/2024.
Claim Objections
Claim 3 is objected to because of the following informalities: The word “and” in the 2nd line of the claim should be replaced with “wherein.” Appropriate correction is required.
Claim 6 is objected to because of the following informalities: The phrase at the end of the claim should be changed from “the breast” to “a breast.” Appropriate correction is required.
Claim 7 is objected to because of the following informalities: The word “and” in the 2nd line of the claim should be replaced with “wherein.” Appropriate correction is required.
Claim 7 is objected to because of the following informalities: The word “forming” in the 3rd line of the claim should be replaced with “forms.” Appropriate correction is required.
Claim 8 is objected to because of the following informalities: The word “and” in the 2nd line of the claim should be replaced with “wherein.” Appropriate correction is required. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The word “which” in the 3rd line of the claim should be replaced with “wherein the.” Appropriate correction is required.
Claim 11 is objected to because of the following informalities: The word “and” in the 2nd line of the claim should be replaced with “wherein.” Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The word “which” in the 4th line of the claim should be replaced with “wherein the.” Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The word “in” in the 4th line of the claim is repeated twice. 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 1-14 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.
[Claim 1] The claim recites the limitation of “an insert arranged within the housing and between the nipple tunnel and the milk port and/or the vacuum port” in the 5th and 6th lines of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear which structures the “insert” is required to be “between.” For purposes of examination, it is interpreted that the insert which is “between” any two of the nipple tunnel, milk port, and vacuum port, meets the limitations of the claim.
[Claims 2-14] 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)(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.
Claims 1-6 and 8-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pollen et al. (PGPub 2015/0217035).
[Claim 1] Pollen teaches a breast shield (figure 1, items 22/26) comprising a housing (figure 1, item 26) defining a nipple tunnel (figure 2, item 36) and adapted to receive a nipple (paragraph [0061]), wherein the housing (figure 1, item 26) is provided with a milk port (figure 2, item 66) in communication with the nipple tunnel (figure 2, item 36) and a vacuum port (figure 2, items 48/84) in communication with the nipple tunnel (figure 2, item 36) (paragraph [0063]), and an insert (figure 1, item 22) arranged within the housing (figure 1, item 26) and between the nipple tunnel (figure 2, item 36) and the milk port (figure 2, item 66) and/or the vacuum port (figure 2, items 48/84) (see 112b interpretation above) (figure 2).
[Claim 2] Pollen teaches the limitations of claim 1, upon which claim 2 depends. Pollen further discloses the insert (figure 1, item 22) provided to at least partially extend over at a longitudinal extension of the milk port (figure 2, item 66) and/or the vacuum port (figure 2, items 48/84) (figure 1).
[Claim 3] Pollen teaches the limitations of claim 1, upon which claim 2 depends. Pollen also teaches at least one of the milk port (figure 2, item 66) or the vacuum port (figure 2, items 48/84) extends in radial direction of the nipple tunnel (figure 2, item 36) (figure 1).
[Claim 4] Pollen teaches the limitations of claim 1, upon which claim 4 depends. In addition, Pollen teaches the nipple tunnel (figure 2, item 36) having an open end section (figure 1, item 54) and a closed end section (figure 1, item 64) opposite to the open end section (figure 1, item 54) (figure 1; paragraph [0064]).
[Claim 5] Pollen teaches the limitations of claim 1, upon which claim 5 depends. Pollen further discloses the housing (figure 1, item 26) defining a flange segment (see annotated figure below) shaped to fit against a breast (figure 2, item 34) (figure 2) and a nipple tunnel segment (see annotated figure below) defining the nipple tunnel (figure 2, item 36).
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[Claim 6] Pollen teaches the limitations of claim 1, upon which claim 6 depends. Pollen also discloses the insert (figure 1, item 22) being formed by a unitary body (figure 5) comprising a nipple tunnel insert segment (figure 2, item 32) received within the nipple tunnel (figure 2, item 36) and a flange insert segment (figure 2, item 30) shaped to fit against a breast (figure 2, item 34) (figure 2; paragraph [0061]).
[Claim 8] Pollen teaches the limitations of claim 1, upon which claim 8 depends. Pollen also teaches the insert (figure 1, item 22) is detachably mounted to the housing (figure 1, item 26) (figure 5; paragraph [0064]).
[Claim 9] Pollen teaches the limitations of claim 1, upon which claim 9 depends. In addition, Pollen discloses a sealing (figure 7, items 72/74) arranged between the insert (figure 1, item 22) and the housing (figure 1, item 26) (figure 7; paragraphs [0065], [0071]).
[Claim 10] Pollen teaches the limitations of claim 1, upon which claim 10 depends. Pollen further discloses the insert (figure 1, item 22) having a rigid section (figure 7, item 32) (via seals 72/74) extending in circumferential direction (figure 7), wherein the rigid section (figure 7, item 32) is provided at least one of between the nipple tunnel (figure 2, item 36) and the milk port (figure 2, item 66) or between the nipple tunnel (figure 2, item 36) and the vacuum port (figure 2, items 48/84) (figure 7; paragraphs [0065], [0071]).
[Claim 11] Pollen teaches the limitations of claim 10, upon which claim 11 depends. Pollen also teaches at least a flange insert segment (figure 2, item 30) of the insert (figure 1, item 22) is received within a flange segment (see annotated figure above) formed by the housing (figure 1, item 26) (figure 2).
[Claim 12] Pollen teaches the limitations of claim 1, upon which claim 12 depends. In addition, Pollen discloses a nipple tunnel segment (shown as “tunnel segment” in the annotated figure above) of the housing (figure 1, item 26) and a nipple tunnel insert segment (figure 2, item 32) of the insert (figure 1, item 22) are arranged coaxially (figure 1).
[Claim 13] Pollen teaches the limitations of claim 1, upon which claim 13 depends. Pollen further discloses a support section (figure 1, item 46) defining a diaphragm support (figure 1, item 99) adapted to detachably hold a diaphragm (figure 1, item 28) and to define a pumping chamber (figure 2, item 20), wherein the pumping chamber (figure 2, item 20) is in communication with the vacuum port (figure 2, items 48/84) (figure 2).
[Claim 14] Pollen teaches a breast shield unit (figure 1, item 12) for expressing human breast milk (paragraph [0061]) comprising a unit housing (figure 1, item 24) with a receptacle (figure 1, item 28) adapted to detachably receive a breast shield (figure 1, items 22/26) according to claim 1 (see rejection above), wherein the receptacle (figure 1, item 28) comprises a vacuum interface (figure 1, item 46) for generating a negative pressure in the nipple tunnel (figure 2, item 36) (paragraph [0062]) and a milk interface (figure 1, item 68) leading to a milk container (figure 1, item 42) adapted to store the expressed human breast milk (figure 2, item 14) (paragraph [0065]) and wherein in an inserted stage, in which the breast shield (figure 1, items 22/26) is received within the receptacle (figure 1, item 28) (figure 1), the vacuum port (figure 2, items 48/84) is in communication with the vacuum interface (figure 1, item 46) and the milk port (figure 2, item 66) is in communication with the milk interface (figure 1, item 68).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pollen et al. (PGPub 2015/0217035), in view of O’Toole et al. (PGPub 2018/0361040).
[Claim 7] Pollen teaches the limitations of claim 1, upon which claim 7 depends. Pollen does not specifically disclose a substantially transparent material forms at least one of the insert (figure 1, item 22) or the housing (figure 1, item 26).
However, O’Toole teaches a breast shield (figure 3, item 7) which is formed from a substantially transparent material (paragraphs [0179], [0434]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Pollen, with the use of a substantially transparent material, as taught by O’Toole, in order to provide increased functionality, versatility, and control, by allowing for a means by which a user might more easily correctly align the nipple with the center of the breast shield (O’Toole; paragraph [0179]). Further, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
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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/JASON E FLICK/Primary Examiner, Art Unit 3783 11/25/2025