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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/05/2026 has been entered.
Status of the Claims
The amendment filed 01/05/2026 has been entered. 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 the claim 1 have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
In response to applicant’s argument with respect to the claim 11 have been considered but they are not persuasive. Applicant argues that the cited prior art Knox does not teach or suggest “a removal mechanism forming a loop having a first end connected to the interior surface and a second end connected to the interior surface”.
This is not found persuasive. For instance, as noted in the final rejection, the primary art reference Moench (US 20060260619 A1) explicitly teaches utilizing the interior surface of the rim serves as a ”handle” to provide a significantly more favorable gripping site for the user to position and to remove the device (Moench at [0008], [0019] and [0073]). Meanwhile, Knox teaches a loop-style removal mechanism for menstrual device that allows user to easily locate the removal mechanism within the vaginal canal. A person of ordinary skill in the art, seeking to improve the “gripping site” identified by Moench, would have found it obvious to attach the removal mechanism of Knox to that specific interior surface. Doing so would be nothing more the predictable application of a known removal mechanism (Knox) to a location already designated for removal in Moench.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 line 7 recites “a resilient rim” which should read “the resilient rim”
Appropriate correction is required.
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 1-6 are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Contente et al (US 5295984 A).
Regarding claim 1, Contente teaches a menstrual disc comprising:
a ring-shaped resilient rim (figure 8, resilient circular rim 31) having an outer sidewall (figure 8, outer surface of the rim 31) and a bottom surface (figure 8, bottom surface of the rim 31);
a catchment portion (figure 9, col 9 lines 60-65, body 34 attached to an inner circumference of the rim 31) attached to a circumference of the ring-shaped resilient rim; and
a removal mechanism (figures 7-13, col 10 line 23-25 and col 15 lines 55-60, removal mean 38, 48, or 58 attached to the bottom surface of the rim 31) extending from a portion of the bottom surface of the resilient rim that is spaced apart from the outer sidewall (figure 8, the bottom surface where removal mean 38 is attached is spaced apart from the outer surface of the rim 31).
In the alternative, in the event that this interpretation is not envisaged by applicant, Contente does not expressly teach the removal mechanism extending from a portion of the bottom surface of the rim resilient rim that is spaced apart from the outer sidewall.
However, 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 Contente such that the removal mechanism extending from a portion of the bottom surface of the rim resilient rim that is spaced apart from the outer sidewall as such a modification would have been an obvious matter of design choice involving an rearrangement of parts. A rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.0 VI.C). One of skill in the art motivated to do so for the purpose of improving structural integrity and allowing user to easily locate the removal mechanism within the vaginal canal.
Regarding claim 2, Contente teaches the menstrual disc of claim 1.
Contente further teaches wherein the removal mechanism is a filament (figure 8 and col 15 lines 55-60, removal means in the form of string 38)
Regarding claim 3, Contente teaches the menstrual disc of claim 1.
Contente further teaches wherein the removal mechanism is a molded tab (figure 8 and col 15 lines 55-60, removal means in the form of looped string 38, examiner’s note: “tab” interpreted as a short projecting device, such as a small flap or loop by which something may be grasped or pulled as per Merriam webster definition of term “tab”))
Regarding claim 4, Contente teaches the menstrual disc of claim 1.
Contente further teaches Wherein the removal mechanism forms a loop (figure 8, and col 15 lines 55-60, removal means in the form of looped string 38)
Regarding claim 5, Contente teaches the menstrual disc of claim 4.
Contente further teaches wherein the removal mechanism is a filament (figure 8, and col 15 lines 55-60, removal means in the form of looped string 38)
Regarding claim 6, Contente teaches the menstrual disc of claim 4.
Contente further teaches wherein the removal mechanism is a molded tab (figure 8, col 9 lines 50-56 and col 15 lines 15-60, removal means in the form of a molded looped string 38, examiner’s note: “tab” interpreted as a short projecting device, such as a small flap or loop by which something may be grasped or pulled as per Merriam webster definition of term “tab”)
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Contente et al (US 5295984 A) in view of Knox (US 20160278988 A1).
Regarding claim 8, Contente teaches the menstrual disc of claim 1.
Contente does not teach wherein the removal mechanism has a textured surface.
In the same field of endeavor, namely an absorbent menstrual cup, Knox teaches wherein the removal mechanism has a textured surface (figure 1, projections 16).
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 Contente to incorporate the teachings of Knox and provide the removal mechanism has a textured surface for the purpose facilitating user grip the removal mechanism during insertion and removal, as taught by Knox ([0008]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Contente et al (US 5295984 A) in view Babkes et al (US 20120095492 A1).
Regarding claim 9, Contente teaches the menstrual disc of claim 1.
Contente does not teach 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
In the same field of endeavor, namely an implantable device, Babkes teaches wherein a first portion (figure 1a and [0047], feet 120 having relatively thinner regions, for example mid-point which forms the outermost end of spoke) 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 (Contente teaches the removal mean 38 is attached to the bottom surface that is spaced apart from the outer surface of the rim 31).
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 Contente to incorporate the teachings of Babkes and provides the removal mechanism as claimed for the purpose of allowing the loop to hinge flexibly without pressing against the vaginal wall as taught by Babkes ([0047]), while the second portion of the body provide structural integrity.
Claims 11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Moench et al (US 20060260619 A1) in view of Knox (US 20160278988 A1)
Regarding claim 11, Moench teaches a menstrual disc (figures 11a-b [0074] intravaginal device) comprising:
a catchment portion (figure 11a-b, dome piece 10 has inner and outer surfaces) that has an interior sidewall and an exterior sidewall;
a resilient rim (figures 11a-b [0066] resilient rim 12 coupled to dome piece 10) connected to the catchment portion and having an interior surface(figure 11b, interior surface of rim 12 facing the dome piece 10) facing the exterior sidewall of the catchment portion, an exterior surface (figure 11b, opposite exterior surface) facing away from the exterior sidewall of the catchment portion, and a bottom surface (figure 11b, bottom surface of the rim 12 between interior and exterior surfaces, further illustrated in figure 5 ) between the interior surface and the exterior surface;
the resilient rim having an outer edge (annotated figure 12b, outer edge)
a removal mechanism (interior surface of rim function as a handle, figure 11b and [0073])
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Moench does not teach the removal mechanism forming a loop having a first end connected to the interior surface and a second end connected to the interior surface.
In the same field of endeavor, namely a menstrual cup, Knox teaches a menstrual cup (figures 1-7, 1) comprising a removal device forming a loop having a first end and second end connected to the surface of the rim (figure 6 and [0034], flexible loop 62 having first and second end connected to rim 10).
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 Knox and provide the removal mechanism as claimed for the purpose of facilitating removal of the menstrual device as taught by Knox ([0034]).
Examiner’s note, although Knox does not explicitly teach the loop connected to the interior surface of the rim, Moench explicitly teaches the interior surface of the rim serves as a handle to provide significantly more favorable gripping site for the user to position and to remove the device (Moench [0008], [0019] and [0073]). Therefore, one of skill in the art seeking to improve the interior gripping site identified by Moench would have found it obvious to attach the removal mechanism of Knox to that specific interior surface.
Regarding Claim 13, Moench, as modified by Knox teaches a menstrual disc according to claim 11.
The combination further teaches wherein a top surface of the rim is chamfered at an intersection of the top surface and the exterior surface (Moench; annotated figure 4, chamfered intersection between top surface 13 and exterior surface 20).
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Regarding Claim 14, Moench, as modified by Knox teaches a menstrual disc according to claim 11.
The combination further teaches wherein the removal mechanism is formed with the resilient rim in a single molding process (claimed limitation is considered a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, the burden is shifted to applicant to show an unobvious difference. In the instant case, although Moench and Knox are silent as to the single molding process, it appears that the product of the combination would be the same or similar as the claimed, i.e., Knox teaches resilient rim comprising molded loop, and therefore the apparatus of the combination is considered to be manufactured with the same method).
In the alternative, in the event that this interpretation is not envisaged by applicant, although the cited prior art is silent as to the claimed process above, it appears that the apparatus of Moench and Knox would be the same or similar as that claimed, and therefore one of skill in the art would have been motivated to providing the removal mechanism is formed with the resilient rim in a single molding process for the purpose of providing simple manufacturing process
Regarding Claim 15, Moench, as modified by Knox teaches a menstrual disc according to claim 11.
The combination further teaches wherein the removal mechanism is molded within the resilient rim in a secondary molding process (claimed limitation is considered a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, the burden is shifted to applicant to show an unobvious difference. In the instant case, although Moench and Knox are silent as to the secondary molding process, it appears that the apparatus of the combination would be the same or similar as the claimed, i.e., Knox teaches resilient rim comprising molded loop, and therefore the apparatus of the combination is considered to be manufactured with the same method).
In the alternative, in the event that this interpretation is not envisaged by applicant, although the cited prior art is silent as to the claimed process above, it appears that the product of Moench and Knox would be the same or similar as that claimed, and therefore one of skill in the art would have been motivated to provide the removal mechanism is formed with the resilient rim in a secondary molding process for the purpose of providing simple manufacturing process
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Moench et al (US 20060260619 A1) in view of Knox (US 20160278988 A1), and in further view of Shihata (US 5207232 A).
Regarding Claim 12, Moench, as modified by Knox, teaches a menstrual disc according to claim 11.
The combination does teaches wherein a cross-sectional shape of the resilient rim is selected from a group consisting of half-domed, triangular, and “U” shaped.
In the same field of endeavor, namely a device for intravaginal, Shihata teaches a cross-sectional shape of the resilient rim is selected from a group consisting of half-domed, triangular, and “U” shaped (figures 14-15, fornical rim 84 comprising extension 89 forming “U” shaped cross-sectional ).
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, as modified by Knox, to incorporate the teachings of Shihata and provide the cross-sectional shape of the resilient rim is selected from a group consisting of half-domed, triangular, and “U” shaped for the purpose of providing close anatomical sealing and facilitating easy insertion and removal, as taught by Shihata (col 2 lines 45-68).
Conclusion
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.
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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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/SETH HAN/Examiner, Art Unit 3781