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 Claims
Claims 1, 5-8, 10, 12, 15-16, 18-21, 24, 28-29, 31-33 are pending, of which Claim 1 is amended. No new matter is found.
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive.
Applicant first argues that secondary reference Williams discloses a conventional tampon with a medicated polymer applied to the tampon and therefore it is different from the claimed invention of a device having a pharmaceutically active composition that comprises a systemically active composition for vaginal delivery. Examiner respectfully contends that Williams does indeed disclose a covering/coating that comprises steroidal medicaments, which are well known to be capable of causing systemic effects on a patient, thus after modifying Hooi's plug with the covering/coating of composition taught in Williams, Examiner maintains that the combination would render the currently claimed invention obvious.
Applicant then argues that Williams' invention appears to be a generically known medicated tampon and will not be capable of being delivered to the right location for the medicinal composition to be released into the body. Examiner respectfully contends that the current claims do not recite exactly how the current invention can be delivered in an improved fashion as compared to known medicated tampons. In other words, the asserted functional benefit that the current device/tampon can be placed correctly into a user's vagina is not reflected in the claim language. Additionally, a claimed device/product needs to be distinguished from prior art in terms of structure rather than function. Examiner also notes that the current claim(s) do not explicitly recite any structure that supposedly contributes to the current device's ability to be inserted and retained in such a way that enables an active composition to be delivered. It appears to the Examiner that Applicant is asserting that the structures already claimed would necessarily result in the benefit. However, primary reference Hooi already discloses all of the claimed structures except a medicinal composition, thus it is reasonable to expect that Hooi's device/tampon can be delivered to the correct location within the user's vagina, just like the currently disclosed invention. While Hooi's device/tampon lacks the medicinal composition and therefore cannot release a systemically active composition with the user's vagina, this deficiency is ameliorated by Williams' teaching of a tampon covering/coating that can disintegrate within the vagina of a user to release the pharmaceutically active composition within the vagina. Examiner additionally notes that a heat/liquid labile membrane is recited in, e.g., current claim 10, which is the same as Williams’ coating, and thus one skilled in the art has reason to expect the Hooi-Williams combination would yield a device that delivers a systemically active composition as effectively as Applicant’s device.
Applicant’s arguments against previously cited reference D’Augustine is moot because said reference is not used in the current rejection.
Claim Rejections - 35 USC § 103
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.
Claims 1, 5-8, 10, 12, 15-16, 18-21, 24, 28-29, & 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Hooi (WO 2006/123132) in view of Williams (US 4,317,447).
Re Claim 1, Hooi discloses a device for insertion into a human or animal cavity, the device comprising: an internally wearable plug (plug 2, see e.g., Fig. 3); an externally wearable anchor element (pad 3); and a sheath (sheath 4) joining the plug to the anchor element such that a finger can be received in the sheath to assist insertion (e.g., Abstract), wherein the device is configured such that the sheath can invert to accommodate the plug (e.g., Figs. 6-7, page 21 lines 7-14, "The inverted sheath 4 expands in a similar way to when accommodating the wearer's finger during insertion and allows the plug 2 to be drawn into the inverted sheath 4...").
Hooi does not disclose that the plug comprises a pharmaceutically active composition that is systemically active composition for vaginal delivery. Williams discloses an intravaginal tampon coating (polymeric sheath 1, col. 2 lines 6-10 "The present invention related to an improved delivery system wherein the polymer is first impregnated with the medicament and then shaped into a cartridge or capsule which will fit over a carrier such as a tampon.") formed of a pharmaceutically active composition (col. 2 lines 55- 59, where steroidal medicaments such as estradiol and progesterone are known to have systemic effect on the person).
It would have been obvious to one skilled in the art at the time of filing to modify Hooi with the coating taught by Williams since the combination of prior art elements according to known methods to obtain predictable results (i.e., adding a pharmaceutically active composition coating to an absorbent tampon so as to deliver drugs through the vaginal mucosal surface over a prolonged period of time while the tampon absorbs excess fluids, see Williams, col. 3 lines 18- 30) establishes a prima facie case of obviousness (MPEP 2143).
Re Claim 5, Hooi and Williams combine to disclose claim 1, Williams also discloses that wherein the composition comprises a pharmaceutically active ingredient selected from an antifungal agent, an antibacterial agent, an anti-hemorrhoidal agent, and combinations thereof (col. 2 lines 50-55).
Re Claim 6, Hooi and Williams combine to disclose claim 1, Williams also discloses that the composition is releasable in the presence of heat and/or fluid (col. 3 lines 18-22).
Re Claim 7, Hooi and Williams combine to disclose claim 1, Williams also discloses that the composition is selected from the group consisting of a solution, a lotion, a cream, an emulsion, a suspension, an ointment, a paste, a gel (col. 3 line 28, "a thinning of the gel occurs "), a powder and a foam.
Re Claim 8, Hooi and Williams combine to disclose claim 1, Hooi also discloses wherein the plug comprises an absorbent material (e.g., page 20 line 12).
Re Claims 10, 12, & 31, Hooi and Williams combine to disclose claim 1, Williams also discloses that the plug comprises a heat and/or liquid labile membrane (col. 3 lines 18-22) that comprises the pharmaceutically active composition (col. 2 lines 55-59) that is releasable in the presence of heat and/or fluid (col. 3 lines 18-22). Hooi also discloses wherein the plug comprises an absorbent material (e.g., page 20 line 12).
Re Claims 15 & 16, Hooi and Williams combine to disclose claim 1, Hooi also discloses that wherein the anchor element is an externally wearable absorbent pad and comprises an absorbent layer and a liquid impermeable layer (see e.g., Abstract).
Re Claims 18-21, Hooi and Williams combine to disclose claim 1, Hooi also discloses that wherein the sheath is flexible (page 18 lines 16-17) and expandable only in a radial direction (page 18 lines 16-17), wherein the sheath comprises an impermeable layer (page 17 lines 13-14), wherein the impermeable layer is closed where it joins the plug (page 18 lines 1-2).
Re Claim 24, Hooi and Williams combine to disclose claim 1, Hooi also discloses wherein the sheath comprises an internal impermeable layer and an external absorbent layer (page 17 lines 13-14).
Re Claims 28-29, Hooi discloses a method for delivery of the device of claim 1 into a human or animal cavity, the method comprising inserting a finger into the sheath of the device of claim 1 and pushing the plug into the cavity, wherein the cavity is a vaginal cavity (e.g., Abstract). While Hooi does not expressly disclose that this method is for delivering a pharmaceutically active composition or that the method is for treatment of a vaginal condition, with the modification of Williams disclosure of a coating (col. 2 lines 6-10) formed of pharmaceutical composition (col. 3 lines 18-30) that can treat a vaginal condition (col. 2 lines 50-55), the insertion of the Hooi device would necessarily result in the coating being inserted as well, and subsequently resulting in the method being for delivering a pharmaceutically active composition for the treatment of a vaginal condition.
Re Claims 32 & 33, Hooi and Williams combine to disclose claim 28 or 29, Hooi also discloses the device further comprises a cord (string 13) attached to the plug and disposed within the sheath (Fig. 3) when the plug is disposed in the cavity, said method further comprising removing the plug from the cavity by pulling the cord, wherein pulling the cord causes the plug to invert the sheath and expand to accommodate the plug such that the plug is at least partially disposed within the inverted sheath (page 21 lines 7-19).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hussain et al. (The vagina as a route for systemic drug delivery, Journal of Controlled Release, volume 103, issue 2, pages 301-313 (2005)) provides a summary of advances in the field of using the vaginal route for systemic delivery of therapeutic compositions.
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.
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
22 June 2026
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