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 .
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 20, 23 and all claims depending therefrom 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 20, the new matter is applying anterior compression to an anterior portion of the flexible portion of the breast interface with a movable member of the flange; and applying posterior compression to a posterior portion of the flexible portion with the movable member of the flange.
The original specification discloses that the anterior and posterior compression is respectively applied to an anterior and posterior portion of the breast.
Regarding claim 23, the new matter is the applying the anterior compression comprises compressing the first arm against the anterior portion of the flexible portion.
The original specification discloses that applying the anterior compression comprises compressing the first arm against the anterior portion of the breast.
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 20 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grant et al (EP 0198469 B1, hereinafter "Grant").
Regarding claim 20, Grant discloses a method for expression of breast milk from a breast (see Fig. 6), the method comprising:
providing a breast milk expression device comprising a breast interface (flange 40; see Fig. 6) and an actuatable assembly (such as a pump 12 capable of applying negative pressure through a line 22; the pump 12 is consistent with the broadest reasonable interpretation of "actuatable assembly", as reflected in para [0068] of the instant specification describing a pump mechanism as a type of actuatable assembly) operably coupled thereto, the breast interface including a flexible portion (see pg. 4, lines 37-38, disclosing that the flange is flexible);
engaging the breast within a flange of the breast interface (see Fig. 6);
actuating the actuatable assembly to generate negative pressure at the breast interface (i.e., applying negative pressure by use of the pump 12);
applying anterior compression to an anterior portion of the flexible portion with a movable member of the flange (anterior portion 38 of a movable member moves inwardly as indicated by arrows 88 when negative pressure is applied by the pump 12; see Figs. 6 and 7); and
applying posterior compression to a posterior portion of the flexible portion with the movable member of the flange by moving the movable member in response to the anterior compression of the breast against the movable member (posterior portion 32 of the movable member has a maximum thickness [42] and anterior portion 38 has a minimum thickness [44], so vacuum force is first transferred to the minimum thickness 44 to compress the breast at the anterior portion 38, and then additional vacuum force is transferred to the maximum thickness 42 in the posterior direction).
Regarding claim 24, Grant teaches that the movable member is configured to apply the anterior compression and the posterior compression in a temporally coupled manner, such that, when the negative pressure is applied at the breast interface, the anterior compression is applied first and the posterior compression is applied second (the posterior portion 32 has a maximum thickness [42] and anterior portion 38 has a minimum thickness [44], so vacuum force is first transferred to the minimum thickness 44 to compress the breast at the anterior portion 38, and then additional vacuum force is transferred to the maximum thickness 42 in the posterior direction).
Claims 20 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silver et al (U.S. Pub. 2011/0071466 A1, hereinafter "Silver").
Regarding claim 20, Silver discloses a method for expression of breast milk from a breast, the method comprising:
providing a breast milk expression device comprising a breast interface 114 (see Fig. 14) and an actuatable assembly 120 (see Figs. 14-15A) operably coupled thereto, the breast interface including a flexible portion (movement of the knob 120 in the directions indicated by arrows 134 and 136 cause the breast interface 114 to flex inward and outwardly);
engaging the breast within a flange of the breast interface (see Figs. 14-15);
actuating the actuatable assembly to generate negative pressure at the breast interface (axial force is applied in directions 134/136, as shown in Figs. 14 and 15A);
applying anterior compression to an anterior portion of the flexible portion with a movable member of the flange (pushing movable member 114 in the direction indicated by arrow 136, as shown in Fig. 15A, causing the anterior portion to be compressed by a portion of the flange),
applying posterior compression to a posterior portion of the flexible portion with the movable member of the flange by moving the movable member in response to the anterior compression of the breast against the movable member (pushing movable member 114 in the opposite direction, indicated by arrow 134, causing the posterior portion 124 to be compressed).
Regarding claim 21, Silver discloses the method of claim 20, further comprising moving an anterior portion of the movable member away from the breast and moving a posterior portion of the movable member towards the breast in response to generation of negative pressure at the breast interface (i.e., the same pushing of the movable member 114 in the opposite direction, indicated by arrow 134, causing the posterior portion 124 to be compressed, as discussed above).
Regarding claim 24, Silver discloses the method as in claim 20, wherein the steps of applying the anterior compression and applying the posterior compression are temporally coupled, such that when negative pressure is generated at the breast interface, the anterior compression is applied first, and the posterior compression is applied second (see temporality illustrated in Figs. 14 and 15A).
Allowable Subject Matter
Claims 22 and 23 are objected to for reciting allowable subject matter.
Response to Arguments
Applicant’s arguments filed on 08/13/2026 have been considered but are not fully persuasive.
Applicant argued that neither Grant nor Silver disclose the claimed subject matter, specifically, a moveable member of a flange “that is a separate and distinct component from a flexible portion of a breast interface that is arranged to engage the flexible portion of the breast interface” (see Remarks, pg. 4). But it is noted that the claimed invention does not require that the flange be separate and distinct from the flexible portion of a breast interface. Claim 20 requires “the breast interface including a flexible portion; [and] engaging the breast within a flange of the breast interface”. Both Grant and Silver disclose an entirely flexible breast interface that also includes a flange; the claimed invention does not require what material the flange must be made from, much less that it be “separate and distinct” from the flexible portion of the breast interface.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 09/10/2026
