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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/1/2025 has been entered.
Status of Claims
Claims 1, 5-8, 10, 12, 15-16, 18-21, 24, 28-29, 31-33 are pending, of which Claims 1, 28-29 are amended and Claims 32-33 are new. All claims are examined on the merits. No new matter is found.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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. 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 are known “pharmaceutically active” compositions).
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 18-19, 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).
Re Claims 20-21, Hooi and Williams combine to disclose claim 1, Hooi also discloses 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 Claim 32, Hooi and Williams combine to disclose claim 28, 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).
Re Claim 33, Hooi and Williams combine to disclose claim 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
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/SUSAN S SU/Primary Examiner, Art Unit 3781
20 November 2025