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 .
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, the “collar” in claim 22 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.
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 3-11 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 claims 3-11, the scope of the claims is unclear because it recites duplicate limitations of the breast portion and areola portion providing a latch portion thus making it unclear if there are two latch portions. Furthermore, the claims recite a plurality of discrete circumferentially spaced elongated recesses and it is unclear if the recited at least one elongate recess in the independent claim are part of this plurality of discrete recesses as suggested in the original disclosure or are separate recesses as suggested in the claims.
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.
Claim(s) 1, 3-4, 12-14, 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0102388 to Lewis et al. (Lewis) in view of US 2016/0081884 to Palmer et al (Palmer).
Regarding claim 1, Lewis discloses a nipple (10) comprising a base portion (18) for attachment to an external component, a breast portion (A, Fig 3 below) extending from the base portion, an areola portion (B, Fig 3 below) extending from breast portion, a teat portion (C, Fig 3 below) extending from areola portion, wherein breast portion extends at a first angle (D) relative to axis of the base portion and areola portion extends at a second angle (E, Fig 3 below) relative to axis of base portion, the first angle being greater than second angle (Fig 3 below). Lewis further teaches breast and areola portion providing a latch portion but does not teach the latch portion comprising at least one elongate recess. Palmer disclose a nipple (10) and in particular discloses a latch portion comprising at least one elongate recess (28) extending circumferentially around an inner surface thereof (Fig 2d). One of ordinary skill in the art would have found it obvious to incorporate an elongate recess to Lewis as suggested by Palmer in order to facilitate collapsing.
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Regarding claim 3, Lewis teaches the nipple of claim 1 and further teaches breast and areola portion providing a latch portion but does not teach the latch portion comprising a plurality of discrete, circumferentially spaced elongate recesses. Palmer discloses a nipple (10) and in particular discloses the nipple having a latch portion comprising a plurality of discrete circumferentially spaced elongate recesses (28) extending circumferentially around an inner surface thereof, the recesses forming a discontinuous ring of recesses (Fig 2c-2d). One of ordinary skill in the art would have found it obvious to incorporate spaced recesses to Lewis as suggested by Palmer in order to make the latch portion less stiff and pliable (Palmer, €0026).
Regarding claim 4, the modified Lewis further teaches the recesses (28, Palmer) are arranged in repeating pattern along discontinuous ring.
Regarding claim 12, the modified Lewis further teaches each recess (28, Palmer) providing a region of reduced wall thickness (Fig 3a).
Regarding claim 13, the modified Lewis further teaches latch portion (30, Palmer) has a smooth outer surface at each recess (Figs 2a, 3a).
Regarding claim 14, Lewis further discloses breast portion (A, Fig 3 above) frustoconical in shape (Fig 3).
Regarding claim 17, Lewis further discloses areola portion (B, Fig 3 above) frustoconical (Fig 3).
Regarding claim 18, Lewis further discloses breast portion (A), areola portion (B), teat portion (C) provided by continuous outer wall (Fig 3).
Regarding claim 19, Lewis further discloses teat portion (C) extends from areola portion (B) at a shoulder portion, diameter of the areola portion (B) adjacent to shoulder portion (S, Fig 3 above) is greater than diameter of the teat portion (C) adjacent shoulder portion.
Regarding claim 20, Lewis further discloses breast, areola, teat and shoulder provided by a continuous wall (Fig 3).
Regarding claim 21, Lewis further teaches nipple provided by continuous outer wall (Fig 3).
Regarding claim 22, Lewis further discloses the nipple (10) and a collar (34).
Claim(s) 5-11, as best understood is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Palmer and US Patent No. 9,295,615 to Tollman.
Regarding claim 5, the modified Lewis teaches the nipple of claim 1 and further teaches breast and areola portion providing a latch portion but does not teach the latch portion comprising a plurality of discrete, elongate recesses. However, Tollman discloses a nipple (Fig 1) and in particular discloses the nipple having a latch portion comprising a plurality of discrete elongate recesses (3e) extending circumferentially around an inner surface thereof and being positioned at discrete positions along an axial direction of the latch portion, to form a plurality of axially spaced discontinuous rings of recesses (from 3e to 3a). One of ordinary skill in the art would have found it obvious to incorporate elongated recesses to Lewis as suggested by Tollman in order to facilitate flexibility (Tollman, col. 1, ll. 40-45).
Regarding claim 6, the modified Lewis further discloses the recesses arranged in a repeating pattern along each discontinuous ring (Fig 1, Tollman).
Regarding claim 7, the modified Lewis further discloses the recess of each ring arranged such that the ends of the recesses are circumferentially offset from end of recesses of adjacent rings (Fig 1, Tollman).
Regarding claim 8, the modified Lewis further teaches center point between any two adjacent recesses on each ring is substantially circumferentially aligned with a circumferential center point of one of the recesses on any adjacent ring (Fig 1).
Regarding claims 9-10, the modified Lewis further teaches the positioning of the rings in relation to the breast and areola portion since Tollman discloses the rings throughout interior of the breast and areola portion (Fig 1).
Regarding claim 11, the modified Lewis further teaches the rings arranged concentrically (Tollman, Fig 1).
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive. Applicant argues the drawing objection, arguing that one of ordinary skill in the art would know what a collar is. This is not persuasive because claimed subject matter needs to be shown in the drawings and the claims recite a collar in combination with a nipple and assuming one of ordinary skill in the art knows what a collar is, it would still not be clear to one of ordinary skill in the art how the collar interacts with the nipple to form a nipple assembly as claimed.
Applicant further argues that prior art does not teach a latch portion comprising at least one elongate recess extending circumferentially around an inner surface thereof because the recesses of Palmer are ovoidally shaped and not elongate. This is not persuasive because an ovoidal shape is an elongated shape because it has one dimension longer than another dimension. Applicant further argues that Tollman does not teach a plurality of axially spaced discontinuous rings of recesses because Tollman describes indentations (3a-3e) as shallow elliptical indentations. However, these indentations form a plurality of axially spaced discointouous rings of recesses because an indentation is a recess and as shown in Fig 1, the indentations are discontinuous, thus forming a plurality of axially spaced rings.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT POON whose telephone number is (571)270-7425. The examiner can normally be reached Monday thru Friday, 8:30 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571)272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT POON/Examiner, Art Unit 3735
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