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 were received on 3/17/2026. These drawings are acceptable.
Response to Arguments
The previous objection of claims 8-9 due to minor informalities has been withdrawn in light of applicant’s amendments made 3/17/2026.
The previous rejection of claim(s) 10-11 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 10 and 11 on 3/17/2026.
The previous rejection of claim 8 over 35 U.S.C. 101 as being directed to or encompassing a human organism has been overcome in light of the amendments made to claim(s) 8 on 3/17/2026.
The rejection of claims 1-4, 6-8 and 20 under 35 U.S.C. 102(a)(1) as being anticipated by Abbott (US 2004/0215164) has been withdrawn in light of applicant’s amendment made 3/17/2026. Specifically, Abbott does not teach the proximal end transitioning into the middle section along a continuously convex surface.
Applicant’s arguments with respect to claims 1-4, 6-8 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Acien Alvarez et al. (US 2020/0060803 A1) teaches said limitation.
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.
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) 1-4, 6-8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbott et al. (US 2004/0215164 A1) in view of Acien Alvarez et al. (US 2020/0060803 A1).
Regarding claim 1, Abbott discloses a vaginal mold (vaginal douche 10; Figs. 1-2) comprising: a rigid, at least partially hollow body (vaginal douche applicator or treatment device 12 which is rigid because it does not deform in shape when it is applied within the body and because 12 is made from a plastic coated in stainless steel, which is a rigid material; [0070]; Fig. 12) defining a cavity (lumen 15; Fig. 1) and comprising a proximal end (at head or tip 55; it is noted that applicant’s proximal end 104, 204 faces the apex of the patient’s vagina [0083]; therefore, the distal end or tip 55 of Abbott is equivalent to applicant’s proximal end), a middle section (portion of 12 between 55 and securing structure 18; Figs. 1-2), and a distal end (at securing structure 18 and adaptor 24; Fig. 2); wherein the proximal end (at 55) comprises a spherical dome-like (wherein “dome-like” is understood by the drawings and specification to define a bulbous, globular shape), bulbous, globular shape (Figs. 1-2); the middle section comprises tapering right and left sides (Figs. 1-2); and the distal end comprises front and back tapering sides and bottlenecks to form a neck (at circumferential groove 34) that ends into a knob (24) comprising an opening (opening at end of 24) to the cavity (Fig. 2).
Abbott fails to explicitly disclose the proximal end transitioning into the middle section along a continuously convex surface.
However, Acien Alvarez teaches a vaginal mold (neovaginal prosthesis; Figs. 1-3) comprising: an at least partially hollow body (main body 1) defining a cavity (lumen between first orifice 5 and second orifice 7) and comprising a proximal end (toward first orifice 5, including upper end 2), a middle section (section between 5 and 7), and a distal section (toward second orifice 7); wherein the proximal end comprises a spherical dome-like, bulbous, globular shape (see dome-like portion towards 5; Figs. 1-2), the proximal end transitioning into the middle section along a continuously convex surface (see convexly rounded surface between dome-like portion and middle section; Figs. 1-2); the middle section comprises tapering right and left sides (Figs. 1-3); and the distal end comprises front and back tapering sides (Figs. 1-3). Acien Alvarez teaches the proximal end to the middle section has an essentially rounded geometry to create a vaginal cavity or neovagina with a suitable luminar diameter by means of dilation ([0020]). Thus, the same of the vaginal mold is designed to match the shape of a patient’s vaginal anatomy ([0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the vaginal mold of Abbott to transition into the middle section along a continuously convex surface as taught by Acien Alvarez to better fit the vaginal mold to match the shape of the patient’s anatomy. Further, the change is shape between the proximal section and the middle section is a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed vaginal mold was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 2, Abbott modified discloses the invention as claimed above, and Abbott further discloses one or more perforations (at least head channels 72 and/or discharge holes 70, 78) to facilitate drainage of vaginal fluids through the opening of the cavity (channels 70, 78 are capable of both dispensing fluid and draining fluid as they are open to the cavity 15).
Regarding claim 3, Abbott modified discloses the invention as claimed above, and Abbott further discloses wherein the one or more perforation (72) are disposed on the proximal end (55) of the body (Fig. 5).
Regarding claim 4, Abbott modified discloses the invention as claimed above, and Abbott further discloses wherein the proximal end (55) has a rotationally symmetric spherical shape (Figs. 1-8).
Regarding claim 6, Abbott modified discloses the invention as claimed above, and Abbott further discloses wherein the knob (24) further comprises a lip (outer protruding portion proximal of groove 34; Fig. 2).
Regarding claim 7, Abbott modified discloses the invention as claimed above, and Abbott further discloses wherein the body is made of biocompatible plastic (plastic which is biocompatible as it is inserted into a patient’s vagina; [0070]; Fig. 12).
Regarding claim 8, Abbott modified discloses the invention as claimed above, and Abbott further discloses one of more internal channels (discharge holes 70, 78) to facilitate flow of fluid to the exterior surface of the mold that contacts a patient's vaginal tissue ([0051]; Fig. 12).
Regarding claim 20, Abbott discloses a vaginal mold (vaginal douche 10; Figs. 1-2), comprising: a rigid, at least partially hollow body (vaginal douche applicator or treatment device 12 which is rigid because it does not deform in shape when it is applied within the body and because 12 is made from a plastic coated in stainless steel, which is a rigid material; [0070]; Fig. 12) defining a cavity (lumen 15; Fig. 1) and comprising a proximal end (at head or tip 55; it is noted that applicant’s proximal end 104, 204 faces the apex of the patient’s vagina [0083]; therefore, the distal end or tip 55 of Abbott is equivalent to applicant’s proximal end), a middle section (portion of 12 between 55 and securing structure 18; Figs. 1-2), and a distal end (at securing structure 18 and adaptor 24; Fig. 2); wherein the proximal end comprises a spherical rotationally symmetric, dome-like (wherein “dome-like” is understood by the drawings and specification to define a bulbous, globular shape), bulbous, globular shape (Figs. 1-2) comprising one or more drainage perforations (discharge holes 70, 78); wherein the middle section comprises tapering right and left sides (Figs. 1-2); and wherein the distal end comprises front and back tapering sides and bottlenecks (at circumferential groove 34) to form a neck (34) that ends into a knob (adaptor 24) comprising a lip (outer protruding portion proximal of groove 34; Fig. 2) and an opening (proximal opening of 24) to the cavity (15; Fig. 2).
Abbott fails to explicitly disclose the proximal end transitioning into the middle section along a continuously convex surface.
However, Acien Alvarez teaches a vaginal mold (neovaginal prosthesis; Figs. 1-3) comprising: an at least partially hollow body (main body 1) defining a cavity (lumen between first orifice 5 and second orifice 7) and comprising a proximal end (toward first orifice 5, including upper end 2), a middle section (section between 5 and 7), and a distal section (toward second orifice 7); wherein the proximal end comprises a spherical dome-like, bulbous, globular shape (see dome-like portion towards 5; Figs. 1-2), the proximal end transitioning into the middle section along a continuously convex surface (see convexly rounded surface between dome-like portion and middle section; Figs. 1-2); the middle section comprises tapering right and left sides (Figs. 1-3); and the distal end comprises front and back tapering sides (Figs. 1-3). Acien Alvarez teaches the proximal end to the middle section has an essentially rounded geometry to create a vaginal cavity or neovagina with a suitable luminar diameter by means of dilation ([0020]). Thus, the same of the vaginal mold is designed to match the shape of a patient’s vaginal anatomy ([0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the vaginal mold of Abbott to transition into the middle section along a continuously convex surface as taught by Acien Alvarez to better fit the vaginal mold to match the shape of the patient’s anatomy. Further, the change is shape between the proximal section and the middle section is a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed vaginal mold was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 5 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbott et al. (US 2004/0215164 A1) in view of Acien Alvarez et al. (US 2020/0060803 A1), as applied to claim 1 above, and further in view of Calvin et al. (US 2022/0143300 A1).
Regarding claim 5, Abbott modified fails to disclose a superior plateau aspect.
However, Calvin teaches a vaginal mold (douche apparatus; [0011]; Figs. 1E-1H) with a proximal end (i.e., distal end of 300 as discussed above with respect to claim 1) comprising a spherical dome-like, bulbous, globular shape (Figs. 1E-1H) comprising a superior plateau aspect (as the distal-most end of the spherical dome-like, bulbous, globular shape is flat i.e., a plateau).
It would have been obvious to one of ordinary skill int the art before the effective filing date of the claimed invention to modify the spherical dome-like, bulbous, globular shape of modified Abbott to include a superior plateau as taught by Calvin since it has been held that changing the shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed plateau was significant and applicant appears to place no criticality on the superior plateau aspect. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claims 9-11, Abbott modified discloses the vaginal mold of claim 1 (see claim 1 above) comprising at least one therapeutic agent (as a container containing one or more therapeutic substance or other additives can be couped between the vaginal douche applicator 12 and source 14 of fluid; [0040]) but fails to disclose a kit comprising a plurality of the vaginal mold of claim 1, wherein the vaginal molds are provided in incrementally larger sizes for gradual upsizing over time, wherein the plurality comprises 2 or more vaginal molds, and wherein the plurality comprises 3 or more vaginal molds and the kit further comprises a package insert with instructions for use.
However, Calvin teaches a kit (kit; [0098]) comprising a plurality of vaginal molds (flushing stent device 100 that is used for douching; Figs. 1A-1B; [0097]; wherein the kit comprises a plurality of flushing stent devices 100; [0098]), wherein the vaginal molds are provided in incrementally larger sizes for gradual upsizing over time (as the plurality of flushing stent devices 100 of the kit are different sizes; [0098]). The kit comprises at least 2 vaginal molds (plurality of devices 100 i.e., one or more; [0098]) and instructions for use ([0098]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vaginal mold of modified Abbott to come in a kit with 3 or more vaginal molds of incrementally larger sizes and a package insert with instructions for use in light of the teachings of Calvin in order to allow a proper and more precise fit to a user and allow the user to treat themselves in an over the counter sterile package.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rivera (US 2022/0370772 A1) is noted for teaching a rigid vaginal mold.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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