DETAILED ACTION
This Office Action is responsive to the Amendment filed 10 November 2025.
Claims 2-15 and 17-22 are now pending. The Examiner acknowledges the
amendments to claims 2, 11 and 20, as well as the cancellation of claim 16 and the
addition of claim 22.
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 .
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 2-15 and 17-22 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 2 at line 4 recites “a central portion comprising a hollow chamber formed from a plurality of legs…”. It is unclear if this recitation is intending to imply that the central portion (or the hollow chamber) is formed from a plurality of legs. For purposes of examination, the interpretation of this recitation will be outlined in the art rejection below (with respect to claim 2).
Claim 20 recites “a central portion comprising a hollow chamber formed from a plurality of legs…”. It is unclear if this recitation is intending to imply that the central portion (or the hollow chamber) is formed from a plurality of legs. For purposes of examination, the interpretation of this recitation will be outlined in the art rejection below (with respect to claim 20).
Claim Rejections - 35 USC § 102
5. 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.
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claims 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ziv et al. (U.S. Pub. No. 2009/0266367). Regarding claim 20 and in view of its indefinite nature, Ziv et al. (hereinafter Ziv) discloses a vaginal device 810/820 comprising: a body configured to be inserted into a vagina (Figs. 5A-5D;11A-11C; [0224]-[0225] and [0241]), the body comprising: a proximal insertion portion (“upper connector portion” 159) ([0225]; Figs. 5A-5C and Figs. 11A-11C); and a central portion 152 comprising a hollow chamber (as disclosed at [0224]-[0228] which indicates that element 152 is a tube and a smaller tube 156 slides telescopically therein), wherein the central portion 152 is further formed from a plurality of legs 302 extending distally from the proximal insertion portion 159 to a distal surface (“lower connector portion” 158) (Figs. 5A-5D;11A-11C; [0225], [0228]), wherein a thickness of each of the plurality of legs 302 varies along a longitudinal axis of the body due to four curves as shown in Fig. 11C [0241].
Regarding claim 21, the thickness of each of the plurality of legs 302 decreases along the longitudinal axis from a central point of each leg to a distal end of each leg (the “central point” being of each leg 302 in the expanded configuration as shown in Fig. 11C, to the distal end of each leg which curves back towards the device as shown in Fig. 11C).
Regarding claim 22, a width of each of the plurality of legs 302 varies along the longitudinal axis of the body due to four curves as shown in Fig. 11C [0241].
Claim Rejections - 35 USC § 103
8. 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.
9. 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.
10. Claims 2, 4, 9-15, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Harmanli (U.S. Pub. No. 2013/0025604) in view of McLaughlin et al. (U.S. Patent No. 5,483,976). Regarding claim 2, Harmanli discloses a vaginal device 10 comprising: a body configured to be inserted into a vagina (Fig. 1 and [0047]-[0055]), wherein the body comprises: a proximal insertion portion 18; and a central portion formed from a plurality of legs 24, which encompass/define a hollow chamber, wherein the legs extend distally from the proximal insertion portion to a distal surface 20 (Figs. 1-3 and [0048]-[0055]), wherein the body further comprises a compressed configuration (Fig. 2) and an expanded configuration (Fig. 3), and wherein in the expanded configuration (Fig. 3), a length of the central portion is longer than the proximal insertion portion 18 along a longitudinal axis of the body (Fig. 3 and [0041]-[0043]).
However, while Harmanli fails to disclose explicitly that the length of the central portion is at least three times the length of the proximal insertion portion 18, Harmanli makes such obvious as Harmanli discloses that the cord 32, which is attached to the proximal insertion portion 18 and extends down through the central portion, has a length ranging from about 15 cm to about 30 cm [0055], thus in view of the attachment point of 32 to the proximal insertion portion 18 along a longitudinal axis of the body, it would be obvious that the central portion is at least three times the length of the proximal insertion portion 18, given the defined range of lengths of the cord 32.
However, Harmanli fails to disclose that the proximal insertion portion is solid. McLaughlin et al. (hereinafter McLaughlin) discloses a body configured to be inserted into a patient for controlling continence, wherein the body comprises a compressed and expanded configuration, having a proximal insertion portion (end cap 14/114/214) and a plurality of legs 215 which provide the expanded/compressed configuration (Figs. 1-3B and col. 6, lines 58-67). McLaughlin further teaches that the proximal insertion portion is solid as in order to deploy the device, the proximal end of the inner tube abuts the end cap of the outer tube (col. 7, lines 6-13). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the proximal insertion portion of an expandable/compressible device for tissue support as taught by Harmanli, to comprise an end cap of solid material as suggested by McLaughlin, as Harmanli likewise teaches inner/outer tubular members for expansion/compression of the device ([0048]-[0055]), and McLaughlin recognizes that a solid end cap enables such expansion of the legs to effect deployment of the device during insertion (col. 7, lines 6-19).
Regarding claim 4, Harmanli fails to disclose explicitly that the spokes/plurality of legs 24 are triangular in cross-sectional shape. Instead, Harmanli indicates that the plurality of legs 24 have a same circular cross-sectional shape (spokes are well-known to be circular) ([0044] and [0048]-[0051]). Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use a spoke of triangular cross-sectional shape because Applicant has not disclosed that a triangular cross-section provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art would have expected Harmanli’s flexible, plurality of spokes providing a circular, cross-sectional shape and applicant’s invention, to perform equally well with either the circular, cross-sectional shape of the legs/spokes as taught by Harmanli or the claimed triangular cross-sectional shape of the legs because both would perform the same function of enabling conformation of the vaginal pessary to the internal anatomy of a patient. Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to modify Harmanli to obtain the invention as specified in claim 4 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Harmanli. Moreover, the instant specification does not provide any criticality of the claimed triangular shape over that of a circular shape, the latter of which is also recognized as an alternative to the cross-sectional shape (see [0034] of the instant publication).
Regarding claim 9, the body of Harmanli further comprises a lateral cross-sectional diameter (as indicated by the double-ended arrow as shown in the reproduction below), and wherein the lateral cross-sectional diameter is largest at a widest point of each of the plurality of legs 24 (interpreted as the point along each leg where the diameter of the device is widest).
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Regarding claim 10, the device of Harmanli further comprises a distal retrieval portion coupled to the distal surface 20 (Fig. 3 and [0056]-[0059]).
Regarding claim 11, while Harmanli fails to disclose explicitly that the length of the proximal insertion portion 18 is about 1/4 a length of the body in the expanded configuration without the distal retrieval portion, Harmanli makes such obvious as Harmanli discloses that the cord 32, which is attached to the proximal insertion portion 18 and extends down through the central portion of the expanded configuration (Fig. 3), has a length ranging from about 15 cm to about 30 cm [0055], thus in view of the attachment point of 32 to the proximal insertion portion 18 along a longitudinal axis of the body, it would be obvious that the length of the proximal insertion portion 18 is about 1/4 a length of the body in the expanded configuration without the distal retrieval portion, given the wide range of lengths of the cord 32.
Regarding claim 12, the distal retrieval portion 40 is integrally formed with the distal surface 20 (Fig. 3 and [0056]-[0058] of Harmanli).
Regarding claim 13, the distal retrieval portion comprises a handle 42 configured to be grasped by a user for removal of the device from the vagina ([0059] and Fig. 4 of Harmanli).
Regarding claim 14, the distal retrieval portion comprises an opening 48 configured to assist a user in grasping the device for removal (Fig. 4 and [0059] of Harmanli).
Regarding claim 15, the distal retrieval portion 40 comprises a flat, elongate structure (“projection” as shown in Fig. 3 and disclosed at [0056]-[0058] of Harmanli).
Regarding claim 18, the device of Harmanli is configured to self-orient within the vagina after insertion due to the flexible and resilient nature of the legs 24 ([0034] and [0043]-[0048]).
Regarding claim 19, the device of Harmanli is formed from silicone [0046].
11. Claims 2, 3, 5-9, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ziv et al. (U.S. Pub. No. 2009/0266367). Regarding claim 2, Ziv et al. (hereinafter Ziv) discloses a vaginal device 810/820 comprising: a body configured to be inserted into a vagina (Figs. 5A-5D;11A-11C; [0224]-[0225] and [0241]), wherein the body comprises:
a solid proximal insertion portion (“lower connector portion” 158) ([0225]; Figs. 5A-5C and Figs. 11A-11C; lower connector portion 158 is deemed to be solid as flat base of the plunger presses against it, causing tube 156 to telescope into the larger tube 152 – [0228], wherein “solid” is deemed to be firm and stable in shape and therefore a solid connector portion 158 would be required to cause tube 156 to telescope into the larger tube when the flat base of the plunger presses against it as described); and
and a central portion 152 comprising a hollow chamber (as disclosed at [0224]-[0228] which indicates that element 152 is a tube and a smaller tube 156 slides telescopically therein), wherein the central portion 152 is further formed from a plurality of legs 302 extending distally from the solid proximal insertion portion 158 to a distal surface at upper connector portion 159) (Figs. 5A-5D;11A-11C; [0224]-[0228]),
wherein the body further comprises a compressed configuration (Figs. 5A, 5C, and 11A-11B) and an expanded configuration (Figs. 5B, 5D and 11C), and wherein in the expanded configuration (Figs. 5B, 5D and 11C), a length of the central portion is longer than the proximal insertion portion 158 along a longitudinal axis of the body (Figs. 5B, 5D and 11C).
However, while Ziv fails to disclose explicitly that the length of the central portion is at least three times the length of the proximal insertion portion 158, Ziv makes such obvious as Ziv discloses that the height of the device in the expanded configuration (when present in the vagina), may be, for example, a height of 2, 3, 4, 5 or more cm, and the expanded device may have an average diameter of between 50 to 120 mm depending on the desired final shape and size of the cavity of the vagina [0206], which would obviate a length of the central portion being at least three times the length of the proximal insertion portion, or (“lower connector portion” 158), as the lower connector portion 158 is in plane with a cross-section of the ring as shown in Figs. 5B and 6A-11C.
Regarding claim 3, a cross-sectional dimension of each of the plurality of legs 302 varies along the longitudinal axis of the body (see Fig. 11C and [0241]).
Regarding claim 5, a width of each of the plurality of legs 302 varies along the longitudinal axis of the body due to four curves as shown in Fig. 11C [0241].
Regarding claim 6, the width of each of the plurality of legs 302 decreases along the longitudinal axis from a central point of each leg to a distal end of each leg (the “central point” being of each leg 302 in the expanded configuration as shown in Fig. 11C, to the distal end of each leg which curves back towards the device as shown in Fig. 11C).
Regarding claim 7, a thickness of each of the plurality of legs 302 varies along the longitudinal axis of the body due to four curves as shown in Fig. 11C [0241].
Regarding claim 8, the thickness of each of the plurality of legs 302 decreases along the longitudinal axis from a central point of each leg to a distal end of each leg (the “central point” being of each leg 302 in the expanded configuration as shown in Fig. 11C, to the distal end of each leg which curves back towards the device as shown in Fig. 11C).
Regarding claim 9, the body further comprises a lateral cross-sectional diameter (as indicated by the double-ended arrow as shown in the reproduction below), and wherein the lateral cross-sectional diameter is largest at a widest point of each of the plurality of legs 302 (interpreted as the point along each leg where the diameter of the device is widest).
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Regarding claim 18, the device is configured to self-orient within the vagina after insertion due to the flexible and resilient nature of the legs (of “the ring”) ([0131] and [0195]).
Regarding claim 19, the device is formed from silicone [0200].
12. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Harmanli (U.S. Pub. No. 2013/0025604) in view of McLaughlin et al. (U.S. Patent No. 5,483,976) and further in view of Bartning et al. (U.S. Pub. No. 2008/0033230). Regarding claim 17, Harmanli discloses that the device comprises a cover/sleeve 26 (Figs. 1-3 and [0052]), however Harmanli and McLaughlin fail to disclose that the device is configured to deliver one or more of a hormone therapy agent, an antibiotic agent, an anti-microbial agent, and an anti-fungal agent. Bartning et al. (hereinafter Bartning) teaches an intravaginal device having a plurality of legs and compressed/expanded configurations ([0029] and [0054]), wherein various pharmacological compounds such as hormone agents [0048] may be associated with a “cover”/coating of the device [0049]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure a cover/coating of an intravaginal device as taught by Harmanli and McLaughlin, to be configured to deliver one or more of a hormone therapy agent, an antibiotic agent, an anti-microbial agent, and an anti-fungal agent as suggested by Bartning, as Harmanli teaches a vaginal pessary for use of an extended period of time and it is well-known that such an extended period of time may require delivery of pharmacological agents to treat local conditions (also see [0049] of Bartning).
Response to Arguments
13. Applicant’s arguments filed 10 November 2025 with respect to the rejection of claims 20-21 under 35 U.S.C. 102(a)(1) citing Ziv (‘367) have been fully considered and are not persuasive. Regarding claim 20, Applicant contends that Ziv fails to disclose a body having a central portion with a hollow chamber and the ring does not form a chamber, let alone a hollow chamber. Claim 20 recites a central portion comprising a hollow chamber, and in Ziv, that is interpreted as central portion 152 comprising a hollow chamber (as disclosed at [0224]-[0228] which indicates that element 152 is a tube and a smaller tube 156 slides telescopically therein, indicating a hollow chamber). In view of the foregoing, the rejection of claims 20-21 under 35 U.S.C. 102(a)(1) citing Ziv (‘367) has been maintained.
14. Applicant’s arguments filed 10 November 2025 with respect to the rejection of claims 2, 3, 5-9, 18 and 19 under 35 U.S.C. 103 citing Ziv (‘367) have been fully considered and are not persuasive. Regarding claim 2, Applicant contends that Ziv fails to disclose a body having a solid proximal insertion portion, and a central portion with a hollow chamber as similarly argued with respect to claim 20 above. For the same reasons noted above, Ziv is maintained with respect to the instant claims. Additionally, Ziv teaches a solid proximal insertion portion (“lower connector portion” 158) as indicated in the rejection above with respect to claim 2 under 35 U.S.C. 103 citing Ziv (‘367).
15. Applicant’s arguments filed 10 November 2025 with respect to the rejection of claims 2, 4, 9-15, 18 and 19 under 35 U.S.C. 103 citing Harmanli (‘604) and claim 16 under 35 U.S.C. 103 citing Harmanli (‘604) in view of McLaughlin (‘976) have been fully considered and are not persuasive. Applicant contends that Harmanli does not disclose a hollow chamber and “expanding/retaining/collapsing means 28” surrounded by spokes 24 does not disclose a hollow chamber. As indicated above, the recitation “a central portion comprising a hollow chamber formed from a plurality of legs…” was found to be indefinite, and therefore the limitation is construed in light of Harmanli to be: a vaginal device 10 comprising: a body configured to be inserted into a vagina (Fig. 1 and [0047]-[0055]), wherein the body comprises: a proximal insertion portion 18; and a central portion formed from a plurality of legs 24, which encompass/define a hollow chamber, wherein the legs extend distally from the proximal insertion portion to a distal surface 20 (Figs. 1-3 and [0048]-[0055]). The “expanding/retaining/collapsing means 28” which Applicant argues in Harmanli is not utilized in this rejection of claim 2. Clarification of the recitation may obviate the rejection. With respect to the contention surrounding the limitation of “a solid proximal insertion portion,” and that McLaughlin fails to teach or suggest a solid end cap, the end cap of McLaughlin is deemed to be solid as in order to deploy the device, the proximal end of the inner tube abuts the end cap of the outer tube (col. 7, lines 6-13) and therefore the end cap would be solid in order to enable such expansion of the legs to effect deployment of the device during insertion (col. 7, lines 6-19). Additionally, it is noted that “solid” in this instance does not preclude a lumen or hollow structure being present; rather solid is construed to be firm and stable in shape and therefore an end cap which is firm and stable in shape (or “solid”) would be required to enable abutment of the inner tube to effect expansion of the legs. In other words, a solid structure could also comprise a lumen or hollow area. In view of the foregoing, the rejection of the claims under 35 U.S.C. 103 citing Harmanli (‘604) in view of McLaughlin (‘976) has been maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791