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 .
Status of the Claims
The amendment filed 05/11/2026 has been entered. At entry, Claims 1-6, 8, 9 and 11-15 are pending and under consideration.
Response to Arguments
In response to the applicant’s argument with respect to 35 USC 102 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
In response to the applicant’s argument with respect to rejection of claims 11 and 13-15 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection of 05/11/2026 has been withdrawn.
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.
Claim 9 is 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 9 recites “that is connected to the portion of the bottom surface of the ring-shaped resilient rim” which renders the claim indefinite. Specifically, Claim 1 recites “a removal mechanism attached only to an inner portion of the bottom surface of the resilient rim”, whereas claim 9 recites that the removal mechanism is connected to the portion of the bottom surface. It is unclear whether “the portion” refers to the inner portion recited in claim 1 or to some other portion of the bottom surface. In an effort to compact prospection, the limitation is being interpreted as “that is connected to the inner portion of the bottom surface of the ring-shaped resilient rim”
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Moench et al (US 20060260619 A1) in view of Shihata (US 5207232 A).
Regarding claim 1, Moench substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
a menstrual disc (figures 11-12 and [0074] intravaginal device) comprising:
a ring-shaped resilient rim (figures 7 11-12 and [0066] resilient rim 12 having an our side wall and a bottom portion 15) having an outer sidewall and a bottom surface;
a catchment portion (figures 11a-b, dome piece 10 attached to the resilient rim 12) attached to the ring-shaped resilient rim; and
a removal mechanism attached only to an inner portion of the bottom surface of the resilient rim that is spaced apart from the outer sidewall.
Moench does not teach a removal mechanism attached only to an inner portion of the bottom surface of the resilient rim that is spaced apart from the outer sidewall.
In the same field of endeavor, namely a device and method for intravaginal, Shihata teaches a removal mechanism (figure 14, rim 84 comprising thickened grip portion 95 attached to an inner portion of vaginal brim 85 and spaced apart from the anterior extension 89) attached only to an inner portion of the bottom surface of the resilient rim that is spaced apart from the outer sidewall.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moench to incorporate the teachings of Shihata and provide the removal mechanism as claimed for the purpose of enabling the menstrual disk to be deployed and/or removed by an applicator as taught by Shihata (col 8 lines 3-45) thereby facilitating aseptic application of the menstrual disk.
Allowable Subject Matter
Claims 2-6, 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 11-15 are allowed.
The following is an examiner’s statement of reasons for allowance: No prior art, alone or in combination, could be found to teach (claim 11) A menstrual disc comprising:
a catchment portion that has an interior sidewall and an exterior sidewall;
a resilient rim connected to the catchment portion and having an interior surface facing the exterior sidewall of the catchment portion, an exterior surface facing away from the exterior sidewall of the catchment portion, and
a bottom surface between the interior surface and the exterior surface; and
a removal mechanism forming a loop having a first end connected to the interior surface and a second end connected to the interior surface.
Applicant’s argument filed 05/11/2026 has been considered and are sufficient to overcome the closest prior art of the record Contente et al (US 5295984 A) Moench (US 20060260619 A1), Knox (US 20160278988 A1) and Shihata (US 5207232 A). While the prior art above teaches the catchment portion + resilient rim as claimed, but they fail to teach a removal mechanism forming a loop having a first end connected to the interior surface and a second end connected to the interior surface. Applicant has demonstrate the claimed arrangement yield unexpected and critical results ([0036]), and accordingly it would have not have been obvious to modify the teachings of the reference to arrive at the claimed invention and expect a reasonable degree of success.
Similarly, Claims 1 + (claims 2, 3, 4, 5, 6, 8 or 9) requires (claim 1) a removal mechanism attached only to an inner portion of the bottom surface of the resilient rim, and (claim 2) wherein the removal mechanism is a filament, (claim 3) wherein the removal mechanism is a molded tab, (claim 4) wherein the removal mechanism forms a loop, (claim 8) wherein the removal mechanism has a textured surface, or (claim 9) wherein a first portion of the removal mechanism has a cross-sectional shape that is thinner than that of a second portion of the removal mechanism that is connected to the portion of the bottom surface of the ring-shaped resilient rim that is spaced apart from the outer sidewall. It would have not have been obvious to one of ordinary skill in the art to modify the interior removal mechanism of Shihata, i.e., thickened grip portion 95, with another as the Shihata is specifically shaped for mating with the applicator, and therefore the modification would alter the intended function of Moench and Shihata without an improvement.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.H./Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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