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 Invention I (claims 1-18) in the reply filed on June 22, 2026, is acknowledged.
Claims 19-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 22, 2026.
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, a textured region (claim 16, line 2) 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.
Specification
The abstract of the disclosure is objected to because:
In lines 1-2, “the same” should be changed to “the breast contacting element for the breast pump assembly”
In line 2, “a breast contacting element” should be changed to “the breast contacting element”
In line 2, “a breast pump assembly” should be changed to “the breast pump assembly”
In line 2, “including” should be changed to “the breast contacting element including”
In line 5, “thereto” should be changed to “to the deformable portion”
In line 6, “a channel” should be changed to “the channel”
In line 7, “a deformable portion” should be changed to “the deformable portion”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The Specification is missing a Cross-Reference to Related Applications section in which it is stated that the application is a 371 of PCT/GB2022/052040, filed 08/03/2022, and claiming foreign priority to GB 2111318.8, filed 08/05/2021.
Appropriate correction is required.
Claim Objections
Claims 1-18 are objected to because of the following informalities:
In regards to claim 1, line 1, “comprising:” should be changed to “the breast contacting element comprising:”.
In regards to claim 1, line 6, “thereto” should be changed to “to the deformable portion”.
In regards to claim 2, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 3, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 4, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 4, line 2, “deformable portion” should be changed to “the deformable portion”.
In regards to claim 4, line 2, “the range” should be changed to “a range”.
In regards to claim 4, line 3, “the range” should be changed to “a range”.
In regards to claim 5, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 5, line 3, the first recitation of “the range” should be changed to “a range”.
In regards to claim 5, line 3, the second recitation of “the range” should be changed to “a range”.
In regards to claim 6, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 7, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 8, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 9, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 10, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 11, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 12, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 13, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 14, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 15, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 16, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 17, line 1, “A breast contacting element” should be changed to “The breast contacting element”.
In regards to claim 18, line 8, “thereto” should be changed to “to the deformable portion”.
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 4-7 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.
In regards to claim 4, line 3 recites “preferably in the range of from 1mm to 1.5mm”. The phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
In regards to claim 5, lines 3-4 recite “preferably in the range of from Shore A 25 to Shore A 50”. The phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
In regards to claim 6, lines 2-3 recite “a plurality of deformable portions”. Claim 6 depends upon claim 1. Claim 1, lines 3-4 recite “a deformable portion”. It is unclear whether the two recitations are the same or different. Claim 7 is rejected by virtue of being dependent upon claim 6.
In regards to claim 7, lines 2-3 recite “preferably comprise from 70% to 80% of the breast contacting surface”. The phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
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.
Claims 1-3, 6, 8, and 10-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Britto et al (US 2005/0245860).
In regards to claim 1, Britto et al teaches a breast contacting element (Figures 1A-7) for a breast pump assembly, comprising:
an opening (48) adapted to receive a nipple of a user's breast
a breast contacting surface (16) extending from the opening and comprising a deformable portion (52) for engaging the user's breast
a channel (34) configured for conveying a fluid pressure from the opening to the deformable portion such that the deformable portion deflects in response to the fluid pressure applied thereto (paragraph [0041])
In regards to claim 2, Britto et al teaches wherein the deformable portion is domed (Figure 3).
In regards to claim 3, Britto et al teaches wherein the deformable portion is configured to invert or flex in response to the fluid pressure applied to the deformable portion (paragraph [0041]).
In regards to claim 6, Britto et al teaches wherein the breast contacting surface comprises a plurality of deformable portions (52) (Figures 1G, 3, 6A-6B).
In regards to claim 8, Britto et al teaches the breast contacting element further comprising a support element (12) comprising an orifice (54), and wherein the deformable portion is formed across the orifice (Figure 3).
In regards to claim 10, Britto et al teaches wherein the deformable portion is coupled to an edge of the orifice (Figure 3).
In regards to claim 11, Britto et al teaches wherein the channel is formed in the breast contacting surface (Figure 3).
In regards to claim 12, Britto et al teaches wherein the channel comprises a recess (34) extending along the breast contacting surface.
In regards to claim 13, Britto et al teaches wherein the breast contacting element comprises a distal opening (46) for operably connecting the breast contacting element to a fluid pressure source, and wherein the channel extends towards the distal opening (Figure 3).
In regards to claim 14, Britto et al teaches wherein the breast contacting element comprises a conduit (18) extending from the opening to the distal opening.
In regards to claim 15, Britto et al teaches wherein the channel extends along an inner surface of the conduit (Figure 3).
In regards to claim 16, Britto et al teaches wherein the breast contacting surface comprises a textured region (Figure 3).
In regards to claim 17, Britto et al teaches wherein the textured region is provided on the deformable portion (Figure 3).
In regards to claim 18, Britto et al teaches a breast pump assembly (Figures 1A-7) comprising:
a conduit (18), operably connectable to a fluid pressure source (Figures 6A-7), the conduit having an opening (48) adapted to receive a nipple of a user's breast
a breast contacting surface (16) extending from the opening and comprising a deformable portion (52) for engaging the user's breast
a channel (34) configured for conveying a fluid pressure generated by the fluid pressure source from the opening to the deformable portion such that the deformable portion deflects in response to the fluid pressure applied thereto (paragraph [0041])
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.
Claims 4, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Britto et al, as applied to claims 1, 6, and 8 above.
In regards to claim 4, Britto et al is silent about wherein deformable portion has a thickness in the range of from 0.5mm to 2mm, preferably in the range of from 1mm to 1.5mm. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify deformable portion, of the breast contacting element of Britto et al, to have a thickness in the range of from 0.5mm to 2mm, preferably in the range of from 1mm to 1.5mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the breast contacting element of Britto et al would not operate differently with the claimed thickness of deformable portion. Further, it appears that Applicant places no criticality on the range claimed for the thickness of deformable portion.
In regards to claim 7, Britto et al is silent about wherein the plurality of deformable portions comprise at least 60% of the breast contacting surface, and preferably comprise from 70% to 80% of the breast contacting surface. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of deformable portions, of the breast contacting element of Britto et al, to comprise at least 60% of the breast contacting surface, and preferably comprise from 70% to 80% of the breast contacting surface, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the breast contacting element of Britto et al would not operate differently with the claimed percentage of the plurality of deformable portions. Further, it appears that Applicant places no criticality on the range claimed for the percentage of the plurality of deformable portions.
In regards to claim 9, Britto et al (Figures 1A-7) does not teach wherein the orifice extends though the support element. Britto et al (Figures 9A-9B) teaches a breast contacting element wherein an orifice (126) extends though a support element (122). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the orifice, of the breast contacting element of Britto et al (Figures 1A-7), to extend through the support element, as taught by Britto et al (Figures 9A-9B), as it is understood that various modifications may be made without departing from the spirit and scope of the invention, wherein the orifice allows the deformable portion to deflect when negative pressure is generated between the deformable portion and breast (paragraph [0044]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Britto et al, as applied to claim 1 above, and further in view of Rohrig (US 2009/0024080).
In regards to claim 5, Britto et al teaches wherein the deformable portion comprises an elastomer (paragraph [0039]); however, Britto et al is silent about the elastomer having a material hardness in the range of from Shore A 20 to Shore A 80, and preferably in the range of from Shore A 25 to Shore A 50. Rohrig teaches a breast contacting element (Figures 1-3) wherein a deformable portion (3) comprises an elastomer having a material hardness in the range of from Shore A 20 to Shore A 80, and preferably in the range of from Shore A 25 to Shore A 50 (paragraph [0012]: Shore hardness A of between 20 and 70, in particular 30 and 40). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the elastomer, of the breast contacting element of Britto et al, to have a Shore hardness A of between 20 and 70, in particular 30 and 40, as taught by Rohrig, which is in the claimed range of from Shore A 20 to Shore A 80, and preferably in the range of from Shore A 25 to Shore A 50, as such will be advantageous for the application of a manual massage pressure (paragraph [0012]).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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