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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 27, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on March 4, 2026. As directed by the amendment: claim 1 has been amended. Thus, claims 1-12 are presently pending in this application.
Terminal Disclaimer
The terminal disclaimer filed on March 4, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent Number 11559614 has been reviewed and is accepted. The terminal disclaimer has been recorded. The filing of the terminal disclaimer has overcome the double patenting rejection.
Response to Arguments
Applicant’s arguments, filed March 4, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive, specifically in regards to McKendry ‘651 not teaching or disclosing the claimed receiving region extending from a breast-side opening and continuously tapering over the entire receiving region. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
retaining means in claim 2. The examiner notes that this limitation is interpreted to mean encircling ribs, and functional equivalents thereof, as set forth in paragraph 109 of the Specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim has been amended to recite that the inner chamber is configured in a conical manner continuously tapering over the entire receiving region. The originally filed disclosure does not provide support for such an amendment. Applicant argues that figs. 2A-C provide support for such an amendment. The figures show a generally conically shaped inner chamber 5; however, these figures also show retaining elements 43 which have an undulating pattern so that the inner chamber does not continuously taper over the entire receiving region. The examiner notes that this interpretation appears supported by Applicant’s interpretation of the prior art. Pg. 7 of the Remarks states “Silver '489 teaches a flexible inner shield part 886 that has "an undulating inboard facing surface" …This undulating, hill-and-valley structure is the opposite of a continuously tapering conical configuration”. Thus, using similar logic, it is the examiner’s opinion that the originally filed disclosure does not provide sufficient support for a continuously tapering receiving region as Applicant’s retaining elements similarly provide an undulating, hill-and-valley structure (figs. 2a-c).
Regarding claim 2, for similar reasons as discussed above, the originally filed disclosure fails to provide support for an inner wall equipped with retaining means and which is continuously tapering over an entire receiving region.
Regarding claim 9, for similar reasons as discussed above, the originally filed disclosure fails to provide support for a shield with a receiving pocket and an inner wall which is continuously tapering over an entire receiving region. Fig. 5a and 5b shows the pocket 46; however, these figures fail to provide support for a continuously tapering receiving region.
Claims 3-8 and 10-12 are also rejected by virtue of being dependent on 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.
Claim(s) 1, 3-5, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silver (US 20020198489).
Regarding claim 1, Silver discloses a breast shield of a breastpump unit for expression of human breastmilk (fig. 11), wherein the breast shield has a vacuum connection (collar 436 in fig. 1) for fluidly connecting an inner chamber (interior 90 in fig. 11) of the breast shield to a vacuum pump for generating pressures (collar 436 is functionally capable of fluidically connecting to a pump and transmitting suction to interior 90), wherein the breast shield has an application region for sealing application to a human breast (see below) and the inner chamber has a receiving region for receiving a nipple of the human breast (conical part 450 below; the region below is capable of receiving a nipple), wherein the receiving region extends from a breast-side opening of the inner chamber in which the nipple is introduced into the breast shield (see below) to a pump-side end of the inner chamber (the examiner notes that the “pump side end” is not further defined structurally or functionally; the end of conical part 450 below is the “pump side end”), wherein the inner chamber is configured in a conical manner continuously tapering over the entire receiving region (see below; fig. 11).
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Regarding claim 3, Silver discloses the breast shield has at least one outer chamber which is configured to at least partially surround the nipple (tapering space 457 in fig. 11), wherein the inner chamber is configured to be subjected to a first pressure by the vacuum pump and the at least one outer chamber is configured to be subjected to at least one second pressure by the vacuum pump (interior 90 and space 457 are both configured to be subjected to pressures from a vacuum pump), wherein the first pressure is an approximately temporally constant pressure and the at least one second pressure is a pulsating pressure (the interior 90 and space 457 are functionally capable of receiving the claimed pressures; paragraph 133 discloses a “rapid intermittent discontinuous pressure” applied to space 457 and paragraph 134 discloses that only negative pressure is communicated to interior 90).
Regarding claim 4, Silver discloses the breast shield has a flexible inner part which subdivides the breast shield into the inner chamber and the at least one outer chamber (flexible inner shield part 447 in fig. 11), and wherein the flexible inner part is able to be subjected to the first pressure from an inside and to the at least one second pressure from an outside (paragraph 133 discloses a “rapid intermittent discontinuous positive pressure fluid” applied to the outside of shield part 447 and paragraph 134 discloses a negative pressure applied to the inside of shield part 447).
Regarding claim 5, Silver discloses the flexible inner part is a flexible insert which is connected one of fixedly or releasably to one of a rigid or semirigid breast shield body (rigid outer shield part 423 in fig. 11 is connected to inner shield part 447).
Regarding claim 11, Silver discloses the inner chamber is bounded by an outer region which is formed in an asymmetrical manner (region formed by pressure channel 444, internal space 446 and channel 457 in fig. 11 form the “outer region” and is shown to be asymmetrical about the longitudinal axis), and in that at least one subregion of the outer region has an outer chamber (pressure channel 444 in fig. 11 is an “outer chamber”), an inner side of which is able to be subjected to a pressure (paragraph 129 discloses pressure is transmitted through channel 444).
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.
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(s) 2, 7, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silver.
Regarding claim 2, Silver discloses all of the claimed limitations set forth in claim 1, as discussed above. However, in this embodiment (fig. 11), Silver does not teach or disclose the inner chamber has an inner wall which is equipped with retaining means for retaining the nipple during a pumping operation.
In a different embodiment (fig. 24), Silver teaches a substantially similar breast shield which comprises an inner chamber (interior 90 in fig. 24) comprising an inner wall (inner wall of tubular part 1056 in fig. 24) which is equipped with retaining means for retaining the nipple during a pumping operation (this limitation is interpreted to mean encircling ribs; circumferential ridges 1072 in fig. 24).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the inner wall of the first embodiment of Silver (tubular part 451 in fig. 11) to comprise retaining means for retaining the nipple during a pumping operation, as taught by the second embodiment of Silver. Silver teaches that these means assist in gripping the nipple during pumping (paragraph 194).
Regarding claim 7, Silver discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the application region ends in an encircling, soft and sealing pad on a breast side.
In a different embodiment (fig. 15), Silver teaches the application region ends in an encircling, soft and sealing pad on a breast side (toroidal gel pack 740 in fig. 15). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the application region of the first embodiment of Silver to end in an encircling, soft and sealing pad on a breast side, as taught by the second embodiment of Silver. Silver teaches that this modification allows for a greater therapeutic effect since the gel pack can be made warm or cold (paragraph 164).
Regarding claim 8, in the modified shield of Silver, the second embodiment of Silver discloses the pad has an encircling inflatable cavity (fig. 15 shows a cavity formed by walls 742 and 738; paragraph 160 discloses the cavity can instead be filled with air, water, or foam so as to be inflatable).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silver, as applied to claim 1 above, and further in view of Alvarez (US 20180078687).
Regarding claim 9, Silver discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the breast shield has a receiving pocket on a breast side for collecting breastmilk drops when the breast shield is removed.
Alvarez teaches a similar shield (fig. 3A) which comprises a generally conical part (interior surface of distal portion 332 is conical) and a more tubular part (proximal portion 336 in fig. 3A). Alvarez further teaches a receiving pocket on a breast side for collecting breastmilk drops when the breast shield is removed (see below; protruding portion 340 in fig. 3A forms a pocket which is capable of collecting milk drops when the shield is removed).
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Since this pocket is formed between the conical part and the more tubular part (fig. 3A), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the shield of Silver to comprise the protruding portion of Alvarez which forms a pocket in between the conical part (450 in fig. 11) and the tubular part (451 in fig. 11). Alvarez teaches that this modification would simulate the gums of an infant’s mouth and can provide pinching of the captured breast tissue (paragraph 39).
Regarding claim 10, in the modified shield of Silver, Silver discloses the breast shield has a flexible inner part which forms the application region and the inner chamber (inner flexible shield part 447 in fig. 11). In modified Silver, Alvarez the receiving pocket is formed in the flexible inner part (fig. 3A shows the pocket formed in membrane 305).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783