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 .
Response to Amendment
The amendment filed on 8/25/2025 has been entered. Claims 1-13, 15-19, and 21-27 are pending in the application. Claims 14 and 20 are cancelled. Claims 1-10 are withdrawn. Claims 21-27 are new. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 2/25/2025.
Claim Objections
Claims 11, 21, and 25-27 are objected to because of the following informalities:
-Claim 11, line 8: please correct “the tubular body first dimension” to “the first dimension”
-Claim 21, line 2: please correct “positioning element” to “the positioning element”
-Claim 25, line 2: please correct “the body” to “the tubular body”
-Claim 26, lines 2-3: please correct “the body” to “the tubular body”
-Claim 27, line 3: please correct “a vaginal cavity” to “the vaginal cavity”
Appropriate correction is required.
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.
Claims 11-13, 15-19, and 21-27 are 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 11 recites multiple different recitations of retention sections in lines 6-13 which are unclear. It is unclear whether the “at least one retention section” in line 7 is one of the plurality of retention sections of lines 6-7 or is an additional retention section(s). It is unclear whether the “at least one of the retention sections” in line 10 is the same as the at least one retention section of line 7, or is another one of the plurality of retentions sections of lines 6-7, or is an additional retention section(s). It is unclear whether “another of the retention sections” in lines 10-11 is the same as the at least one retention section of line 7, or is another one of the plurality of retentions sections of lines 6-7, or is an additional retention section(s). For examination purposes, the Examiner interprets lines 6-13 of claim 11 as “the tubular body further including a plurality of retention sections, at least one retention section of the plurality of retention sections having a second dimension which is larger than the first dimension, the at least one retention section acting as a retention element for securing the insert device in the vaginal cavity; at least one additional retention section of the plurality of retention sections spaced from the at least one retention section and having a third dimension larger than the first dimension and acting as a positioning element, the second dimension of the retention element being larger than the third dimension of the positioning element”.
Claim 11 recites “an opposing end of the insert device” in line 16. It is unclear whether the “opposing end” is one of the “opposing ends” previously recited in line 3 or whether this is an additional opposing end. For examination purposes, the Examiner interprets “an opposing end” in line 16 as “an end of the opposing ends”.
Claims 12-13, 15-19, and 21-27 are rejected by virtue of their dependency on rejected claim 11.
Claim 15 recites “an end of the opposing ends of the insert device” in lines 2-3. With the 112(b) rejection of claim 11 above regarding the opposing ends, it is further unclear whether “an end” in claim 15 is intended to be the same end as that of line 16 of claim 11 or another of the opposing ends. For examination purposes, the Examiner interprets “an end” in claim 15 as “the end”.
Claims 16-18 are rejected by virtue of their dependency on rejected claim 15.
Claim 19 recites “an end of the opposing ends of the insert device” in lines 2-3. With the 112(b) rejection of claim 11 above regarding the opposing ends, it is further unclear whether “an end” in claim 19 is intended to be the same end as that of line 16 of claim 11 or another of the opposing ends. For examination purposes, the Examiner interprets “an end” in claim 19 as “the end”.
Claim 22 recites the limitation “the delivery section” in line 1. This recitation lacks proper antecedent basis. It is unclear what “the delivery section” is. For examination purposes, the Examiner interprets “the delivery section” as “a delivery section”.
Claim 26 recites the limitation “the at least one additional therapeutic agent” in lines 1-2. This recitation lacks proper antecedent basis. It is unclear what “the at least one additional therapeutic agent” is. For examination purposes, the Examiner interprets “the at least one additional therapeutic agent” as “at least one additional therapeutic agent”.
Claim 26 recites the limitation “the delivery section” in line 2. This recitation lacks proper antecedent basis. It is unclear what “the delivery section” is. For examination purposes, the Examiner interprets “the delivery section” as “a delivery section”.
Claim 27 recites “one end of the insert device” in line 2. With the 112(b) rejection of claim 11 above regarding the opposing ends, it is further unclear whether “one end” in claim 27 is intended to be the same end as that of line 16 of claim 11, another of the opposing ends of the insert device, or another end of the insert device altogether. For examination purposes, the Examiner interprets “one end” in claim 27 as “another end of the opposing ends”.
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.
Claims 11-13, 15-19, and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Elman et al. (US 2013/0138134 A1) in view of Heuer et al. (US 2006/0217652 A1).
Regarding claim 11, Elman discloses a vaginal delivery system for delivering at least one therapeutic agent in a vaginal cavity (see Figs. 1A-F, par. [0048]) comprising:
an insert device (inner balloon 102, outer balloon 106, sleeve 130, and the portion of catheter 118 within the balloons forms an insert device) including a flexible tubular body (body of balloons 102/106, sleeve 130, and the portion of catheter 118 within the balloons) with opposing ends (see Figs. 1A-F, par. [0038] and [0040]; the body of the balloons 102/106, sleeve 130, and catheter 118 is flexible and tubular);
the tubular body (body of balloons 102/106, sleeve 130, and the portion of catheter 118 within the balloons) being non-absorbent and hollow and having a first dimension (see Figs. 1C-1D, par. [0038], [0040]; the body of the balloons 102/106, sleeve 130 and catheter 118 is non-absorbent and hollow; the first dimension can be considered the tapered distal tip of the device – see generally at 108 in Fig. 1D);
the tubular body (body of balloons 102/106, sleeve 130, and the portion of catheter 118 within the balloons) further including a plurality of retention sections (anti-slip protrusions 117 and the sections between them), at least one retention section (anti-slip protrusions 117) having a larger second dimension than the tubular body first dimension (see Fig. 1C, par. [0038]; anti-slip protrusions 117 protrude outward from external wall 110, which is a larger dimension than the tapered distal tip of the device), the at least one retention section (anti-slip protrusions 117) acting as a retention element for securing the insert device in the vaginal cavity (see par. [0038]);
at least one of the retention sections (the sections between anti-slip protrusions 117) spaced from another of the retention sections (anti-slip protrusions 117) and having a third dimension larger than the first dimension and acting as a positioning element, the second dimension of the retention element being larger than the third dimension of the positioning element (see par. Fig. 1C, par. [0038]; the anti-slip protrusions 117 protrude outward from external wall 110 such that they have a second dimension which is largest, the portions between anti-slip protrusions 117 have a third dimension which is smaller, and the distal tip of the device tapers to a first dimension which is smallest).
However, Elman fails to expressly state an applicator having an insertion end, the applicator configured for containing the insert device and forming a dosage zone between the insertion end and an opposing end of the insert device, the dosage zone configured for containing the at least one therapeutic agent; an insertion device movable in the applicator, the insertion device having an end configured for engaging the insert device and acting on the insert device to eject the insert device and the at least one therapeutic agent from the applicator and into the vaginal cavity.
Heuer teaches a vaginal delivery system (see Figs. 1-6, par. [0030] and [0048]-[0055]) comprising: an applicator (delivery tube assembly 50) having an insertion end (second end 64), the applicator (delivery tube assembly 50) configured for containing the insert device (tampon 20) and forming a dosage zone (space within delivery tube assembly 50 for dosage form 45, see Fig. 1) between the insertion end (second end 64) and an opposing end of the insert device (tampon 20), the dosage zone (space within delivery tube assembly 50 for dosage form 45, see Fig. 1) configured for containing the at least one therapeutic agent (see par. [0048]-[0055]); an insertion device (second member 18) movable in the applicator (delivery tube assembly 50), the insertion device (second member 18) having an end (end of second member 18 at tampon 20) configured for engaging the insert device (tampon 20) and acting on the insert device (tampon 20) to eject the insert device (tampon 20) and the at least one therapeutic agent from the applicator (delivery tube assembly 50) and into the vaginal cavity (see Figs. 1-6, par. [0069] and [0048]-[0055]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the vaginal delivery system of Elman to include an applicator and insertion device, as taught by Heuer, in order to provide a more comfortable and easier means to insert the system into the vagina and to provide means to insert an additional dosage of a drug to be delivered with the tubular body (see Heuer par. [0042] and [0048]-[0055]).
Regarding claim 12, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. Modified Elman further teaches a dosage amount (Heuer, dosage form 45) of the at least one therapeutic agent (Heuer, see par. [0048]-[0055]), the dosage amount (Heuer, dosage form 45) contained in the dosage zone (Heuer, space within delivery tube assembly 50 for dosage form 45, see Fig. 1) for being ejected with the insert device (Elman, inner balloon 102, outer balloon 106, sleeve 130, and the portion of catheter 118 within the balloons forms an insert device) into the vaginal cavity (see previous modifications in rejection of claim 11 above, see Heuer par. [0069] and [0048]-[0055], Elman par. [0048]).
Regarding claim 13, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. Elman further teaches wherein the tubular body (body of balloons 102/106, sleeve 130, and the portion of catheter 118 within the balloons) includes a delivery section (section at membrane 112) between the opposing ends and further comprising: at least one additional therapeutic agent positioned on the delivery section (section at membrane 112) of the tubular body (body of balloons 102/106, sleeve 130, and the portion of catheter 118 within the balloons); the delivery section (section at membrane 112) configured for contacting a vaginal surface of the vaginal cavity when the insert device is inserted to deliver the at least one additional therapeutic agent to the vaginal surface (see Figs. 1C-1D, par. [0038]).
Regarding claim 15, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. However, modified Elman fails to expressly state a seal positioned around the tubular body of the insert device proximate an end of the opposing ends of the insert device and interfacing with an inner wall of the applicator, the seal configured for assisting in the ejection of the at least one therapeutic agent from the dosage zone.
Heuer teaches a vaginal delivery system (see Figs. 1-6, par. [0030] and [0048]-[0055]) further comprising a seal (inner containment seal 112) positioned around the tubular body (tampon body 34) of the insert device (tampon 20) proximate an end of the opposing ends of the insert device (tampon 20) and interfacing with an inner wall (inner surface 72) of the applicator (delivery tube assembly 50), the seal (inner containment seal 112) configured for assisting in the ejection of the at least one therapeutic agent from the dosage zone (space within delivery tube assembly 50 for dosage form 45, see Fig. 1) (see Figs. 1 and 3, par. [0058]-[0060] and [0048]-[0055]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the vaginal delivery system of modified Elman to further include a seal, as taught by Heuer, in order to seal the therapeutic agent within the applicator during shipping and handling (see Heuer par. [0058]-[0060]).
Regarding claim 16, modified Elman teaches the vaginal delivery system of claim 15 substantially as claimed. However, modified Elman fails to expressly state an additional seal positioned around the tubular body of the insert device proximate another end of the opposing ends of the insert device and interfacing with the inner wall of the applicator, the additional seal configured for assisting in the ejection of the at least one therapeutic agent from the dosage zone.
Heuer teaches a vaginal delivery system (see Figs. 1-6, par. [0030] and [0048]-[0055]) further comprising an additional seal (engagement mechanism 76) positioned around the tubular body (tampon body 34) of the insert device (tampon 20) proximate another end of the opposing ends of the insert device (tampon 20) and interfacing with the inner wall (inner surface 72) of the applicator (delivery tube assembly 50), the additional seal (engagement mechanism 76) configured for assisting in the ejection of the at least one therapeutic agent from the dosage zone (space within delivery tube assembly 50 for dosage form 45, see Fig. 1) (see Figs. 1-2, par. [0043]-[0044] and [0048]-[0055]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the vaginal delivery system of modified Elman to further include an additional seal, as taught by Heuer, in order to provide an improved structural integrity of the applicator (see Heuer par. [0043]).
Regarding claim 17, modified Elman teaches the vaginal delivery system of claim 16 substantially as claimed. Modified Elman further teaches wherein the seal (Heuer, inner containment seal 112) and the additional seal (Heuer, engagement mechanism 76) form an additional dosage zone (Heuer, space between seals 112/76) between the seal (Heuer, inner containment seal 112) and the additional seal (Heuer, engagement mechanism 76) that is configured for containing at least one additional therapeutic agent (Elman, see Figs. 1C-1D, par. [0038]), the insertion device (Heuer, second member 18) acting on the insert device (Elman, inner balloon 102, outer balloon 106, sleeve 130, and the portion of catheter 118 within the balloons forms an insert device), the seal (Heuer, inner containment seal 112), and the additional seal (Heuer, engagement mechanism 76) to eject both the at least one therapeutic agent and the at least one additional therapeutic agent together from the applicator (Heuer, delivery tube assembly 50) when the insert device (Elman, inner balloon 102, outer balloon 106, sleeve 130, and the portion of catheter 118 within the balloons forms an insert device) is ejected in to the vaginal cavity (see previous modifications in rejection of claims 11, 15, and 16 above, see Elman par. [0038] and [0048], Heuer par. par. [0069] and [0048]-[0055]).
Regarding claim 18, modified Elman teaches the vaginal delivery system of claim 15 substantially as claimed. Modified Elman further teaches wherein the seal (Heuer, inner containment seal 112) is positioned proximate to the retention element (Elman, anti-slip protrusions 117) (see previous modifications in rejection of claims 11 and 15 above, see Elman Fig. 1C and par. [0038], Heuer Fig. 3 and par. [0058]-[0060]).
Regarding claim 19, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. However, modified Elman fails to expressly state wherein the insert device includes an engagement feature that extends from an end of the opposing ends of the insert device, the insertion device including a complementary feature for engaging the engagement feature for pushing the insert device into position in the vaginal cavity.
Heuer teaches a vaginal delivery system (see Figs. 1-6, par. [0030] and [0048]-[0055]) wherein the insert device (tampon 20) includes an engagement feature (first member 14) that extends from an end of the opposing ends of the insert device (see Figs. 1-6), the insertion device (second member 18) including a complementary feature (see Fig. 2, outer surface of second member 18 contacts first member 14) for engaging the engagement feature (first member 14) for pushing the insert device (tampon 20) into position in the vaginal cavity (see Figs. 1-2, par. [0031], [0035], and [0069]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the insert device and the insertion device of modified Elman to include an engagement feature and a complementary feature, respectively, as taught by Heuer, in order to provide structures to allow the insertion device to be used to eject the insert device (see Heuer par. [0031], [0035], and [0069]).
Regarding claim 21, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. Elman further teaches wherein the retention element (anti-slip protrusions 117) and the positioning element (the sections between anti-slip protrusions 117) are positioned at opposing ends of the tubular body (body of balloons 102/106, sleeve 130, and the portion of catheter 118 within the balloons) (see Fig. 1C, par. [0038]).
Regarding claim 22, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. Elman further teaches wherein a delivery section (section at membrane 112) is positioned between the retention element (anti-slip protrusions 117) and the positioning element (the sections between anti-slip protrusions 117) (see Fig. 1C, par. [0038]).
Regarding claim 23, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. Modified Elman further teaches wherein the dosage zone (Heuer, space within delivery tube assembly 50 for dosage form 45, see Fig. 1) is positioned between the insertion end (Heuer, second end 64) of the applicator (Heuer, delivery tube assembly 50) and the positioning element (Elman, the sections between anti-slip protrusions 117) of the insert device (Elman, inner balloon 102, outer balloon 106, sleeve 130, and the portion of catheter 118 within the balloons forms an insert device) (see previous modifications in rejection of claim 11 above, see Heuer Figs. 1 and 3, Heuer par. [0048] and [0056]).
Regarding claim 24, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. Elman further teaches wherein the tubular body (body of balloons 102/106, sleeve 130, and the portion of catheter 118 within the balloons) of the insert device (inner balloon 102, outer balloon 106, sleeve 130, and the portion of catheter 118 within the balloons forms an insert device) is made of a non-absorbent material (see par. [0038] and [0040]).
Regarding claim 25, modified Elman teaches the vaginal delivery system of claim 13 substantially as claimed. Elman further teaches wherein the at least one additional therapeutic agent is applied directly on the delivery section (section at membrane 112) of the tubular body (body of balloons 102/106, sleeve 130, and the portion of catheter 118 within the balloons) (see Figs. 1C-D, par. [0038], the additional therapeutic exits through perforations of membrane 112 such that it can be considered as applied directly on the membrane 112).
Regarding claim 26, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. Elman further teaches wherein the at least one additional therapeutic agent is applied on a sheath (membrane 112) that is positioned on the delivery section (section at membrane 112) of the tubular body (body of balloons 102/106, sleeve 130, and the portion of catheter 118 within the balloons) (see Figs. 1C-D, par. [0038], the additional therapeutic exits through perforations of membrane 112 such that it can be considered as applied on the membrane 112).
Regarding claim 27, modified Elman teaches the vaginal delivery system of claim 11 substantially as claimed. Elman further teaches a grip portion (proximal portion of sleeve 130 proximal to the proximal end of balloon 106) positioned at one end of the insert device (inner balloon 102, outer balloon 106, sleeve 130, and the portion of catheter 118 within the balloons forms an insert device) (see Figs. 1C-D), the grip portion (proximal portion of sleeve 130 proximal to the proximal end of balloon 106) being configured for being gripped by a user for manipulating the insert device (inner balloon 102, outer balloon 106, sleeve 130, and the portion of catheter 118 within the balloons forms an insert device) into position in a vaginal cavity (see Figs. 1C-D, par. [0040], this structure can be gripped to insert the deflated device into the vaginal cavity).
Response to Arguments
Applicant’s arguments with respect to claim 11 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783