DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Allowable Subject Matter
The indicated allowability of claims 31-38 is withdrawn in view of the newly discovered reference(s) to Kulick and Weitzner, as necessitated by applicant’s amendments to claim 31 broadening its scope (see below). Rejections based on the newly cited reference(s) follow.
Claim Objections
Claim 31 is objected to because of the following informalities: "recto-vaginal" should read --rectovaginal--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21 and 27-30 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent No. 5,609,559 (Weitzner) as evidenced by Sokol, A, Shveiky, D. “Clinical Anatomy of the Vulva, Vagina, Lower Pelvis, and Perineum.” Global Library of Women's Medicine, (ISSN: 1756-2228) 2008; DOI 10.3843/GLOWM.10000. Web. 23 December 2013 (herein referred to as “Sokol et al.”).
Regarding claim 21, Weitzner teaches an intravaginal device for the control passage of stool in a user (The limitation “for the control of passage of stool in a user” is intended use. Since the device of Weitzner is intended for intravaginal placement to control passage of material through a body passage through selectively actuated compression, the device is capable of placement to perform the claimed intended use. See abstract, col. 4, lines 2-12, Figure 4), the device comprising:
a body (14, 80, 82) configured for fitting entirely within a vaginal cavity of the user (col. 4, lines 28-34); and an expandable portion (12) coupled to the body, the expandable portion movable between an expanded state and a retracted state (col. 3, lines 3-7 and lines 57-60; Figures 8-9); a line (16) coupled to the expandable portion (col. 3, line 6); wherein a longitudinal extent of the body is configured for extending substantially along a length of a vagina of the user to hold the expandable portion in contact with a rectovaginal septum of the user to control the passage of stool through a rectum of the user (“body” 14, 80, 82 extends longitudinally along the extent of the vaginal cavity, Figure 4), the expandable portion configured to expand laterally relative to a longitudinal axis of the body in single direction (Figure 4; col. 4, lines 2-12); and wherein the line is configured for actuating the expandable portion when the line is manipulated, a portion of the line being configured for positioning outside of the vagina of the user when the body is fitted entirely within the vaginal cavity of the user (“expandable portion” 12 is “actuated” or inflated when “line” 16 is “manipulated” to allow inflation, col. 3, lines 10-15).
Sokol et al. defines the recto-vaginal septum as a layer of tissue between the posterior vaginal wall and the anterior wall of the rectum that “extends from the pouch of Douglas to the perineal body”, and “blends with the superior border of the perineal body” (page 6, paragraph 1; Figure 6 and caption; Figure 11 and caption; page 12, paragraphs 3 and 4; Figure 13 and caption). Accordingly, Sokol et al. provides evidence that the expandable member (12) taught by Weitzner is configured to be held in contact with the recto-vaginal septum.
Regarding claim 27, Weitzner teaches the expandable portion (12) includes a thickened area (70) configured for contacting the rectovaginal septum of the user (The limitation “for contacting the rectovaginal septum of the user” is functional language. The device 10 is capable of being placed such that the “thickened area” 70 contacts the rectovaginal septum, Figure 4; See discussion for claim 1.).
Regarding claim 28, Weitzner teaches the device comprises three spaced-apart portions that are configured for stabilizing the device in the vaginal cavity of the user by engaging with different areas of the vagina of the user (The limitation “for stabilizing…areas of the vagina of the user” is functional language. Since “spaced-apart portions” is not further structurally defined, three separate segments may be construed as the claimed “portions” of the device 10 which perform the claimed function of stabilizing and positioning the device within the vagina during use. See Figure 4 and annotated Figure 8 below.).
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Regarding claim 29, Weitzner teaches the expandable portion (12) extends beyond the body (14, 80, 82) in opposite directions perpendicular to a longitudinal place of the body when the expandable portion is in the expandable state (“expandable portion” 12 expands laterally outward perpendicularly from longitudinal axis of device, Figure 6).
Regarding claim 30, Weitzner teaches an applicator coupled to the body (14, 80, 82) to facilitate insertion of the body into the vaginal cavity of the user (Since the “applicator” is not further structurally defined, the lubricant, which is coupled to the outer surface of “body” 14, 80, 82 during insertion, meets the “applicator” limitation as it is disclosed to aid insertion of the device, col. 5, lines 4-5).
Claims 21, 28, 29, 31, 36, 37, and 39 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent No. 2,638,093 (Kulick) as evidenced by Sokol, A, Shveiky, D. “Clinical Anatomy of the Vulva, Vagina, Lower Pelvis, and Perineum.” Global Library of Women's Medicine, (ISSN: 1756-2228) 2008; DOI 10.3843/GLOWM.10000. Web. 23 December 2013 (herein referred to as “Sokol et al.”).
Regarding claim 21, Kulick teaches an intravaginal device for the control passage of stool in a user (The limitation “for the control of passage of stool in a user” is intended use. Since the device of Kulick is intended for intravaginal placement to control passage of material through a body passage through selectively actuated compression, the device is capable of placement to perform the claimed intended use. See abstract, Figure 1), the device comprising:
a body (4) configured for fitting entirely within a vaginal cavity of the user (Figure 1; col. 2, line 20-21); and an expandable portion (25) coupled to the body, the expandable portion movable between an expanded state and a retracted state (col. 4, lines 33-49; col. 4, line 64-col. 5, line 3; col. 5, lines 11-26; Figure 1); a line (27) coupled to the expandable portion (col. 4, lines 50-58; Figure 1); wherein a longitudinal extent of the body is configured for extending substantially along a length of a vagina of the user to hold the expandable portion in contact with a rectovaginal septum of the user to control the passage of stool through a rectum of the user (“body” 4 extends longitudinally along the extent of the vaginal cavity, Figure 1), the expandable portion configured to expand laterally relative to a longitudinal axis of the body in single direction (col. 4, line 47-48; Figure 3); and wherein the line is configured for actuating the expandable portion when the line is manipulated, a portion of the line being configured for positioning outside of the vagina of the user when the body is fitted entirely within the vaginal cavity of the user (“expandable portion” 25 is “actuated” or inflated when “line” 27 is “manipulated” to allow inflation, col. 5, line 50-72; Figure 1).
Sokol et al. defines the recto-vaginal septum as a layer of tissue between the posterior vaginal wall and the anterior wall of the rectum that “extends from the pouch of Douglas to the perineal body”, and “blends with the superior border of the perineal body” (page 6, paragraph 1; Figure 6 and caption; Figure 11 and caption; page 12, paragraphs 3 and 4; Figure 13 and caption). Accordingly, Sokol et al. provides evidence that the expandable member (25) taught by Kulick is configured to be held in contact with the recto-vaginal septum.
Regarding claim 28, Kulick teaches the device comprises three spaced-apart portions that are configured for stabilizing the device in the vaginal cavity of the user by engaging with different areas of the vagina of the user (The limitation “for stabilizing…areas of the vagina of the user” is functional language. Since “spaced-apart portions” is not further structurally defined, three separate segments may be construed as the claimed “portions” of the device which perform the claimed function of stabilizing and positioning the device within the vagina during use. See Figure 1 and annotated Figure 4 below.).
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Regarding claim 29, Kulick teaches the expandable portion (25) extends beyond the body (4) in opposite directions perpendicular to a longitudinal plane of the body when the expandable portion is in the expanded state (Figures 3-4).
Regarding claim 31, Kulick teaches an intravaginal device for the control of stool passage of a user (The limitation “for the control of passage of stool in a user” is intended use. Since the device of Kulick is intended for intravaginal placement to control passage of material through a body passage through selectively actuated compression, the device is capable of placement to perform the claimed intended use. See abstract, Figure 1), the device comprising: an expandable portion (25) having an extended state and a nonextended state (col. 4, lines 33-49; col. 4, line 64-col. 5, line 3; col. 5, lines 11-26; Figure 1); a body (4) supporting the expandable portion, the body extending in a longitudinal direction (Figure 1); an activation mechanism (27, 28) coupled to the expandable portion and configured for external placement relative to a vagina of the user (col. 4, lines 50-63; Figure 1); wherein the body is sized and configured to fit entirely within the vaginal cavity of the user with the longitudinal extent of the body extending substantially along a length of the vaginal cavity to hold the expandable portion in contact with a recto-vaginal septum of the user to control the passage of stool through a rectum of the user (“body” 4 extends longitudinally along the extent of the vaginal cavity, Figure 1); wherein the activation mechanism is configured to actuate the expandable portion between the extended state and the retracted state (col. 4, line 50-col. 5, line 3; col. 5, lines 15-26); and wherein the body is fluidly isolated from the expandable portion (“This balloon or bag is removably retained or positioned in the cavity”, col. 4, lines 33-36; “removable inflatable element”, claim 6; Figures 1-4; Since the ”expandable portion” 25 is removably retained in the “body” 4, then its interior is fluidly isolated from the “body”.).
Regarding claim 36, see discussion for claim 28 above.
Regarding claim 37, see discussion for claim 29 above.
Regarding claim 39, Kulick teaches a line (27) coupled to the expandable portion (25), the line configured to be disposed outside of the vagina of the user when the body is entirely within the vaginal cavity of the user, and the line configured for actuating the expandable portion when the line is manipulated (“expandable portion” 25 is “actuated” or inflated when “line” 27 is “manipulated” to allow inflation, col. 5, line 50-72; Figure 1).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 27, 30, 35, and 38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 2,638,093 (Kulick) as evidenced by Sokol, A, Shveiky, D. “Clinical Anatomy of the Vulva, Vagina, Lower Pelvis, and Perineum.” Global Library of Women's Medicine, (ISSN: 1756-2228) 2008; DOI 10.3843/GLOWM.10000. Web. 23 December 2013 (herein referred to as “Sokol et al.”) in view of U.S. Patent No. 5,609,559 (Weitzner).
Regarding claims 30 and 38, Kulick teaches all the limitations of claim 21 or 31. Kulick does not teach the device further comprises an applicator coupled to the body to facilitate insertion of the body into the vaginal cavity of the user.
However, Weitzner teaches an intravaginal device for the control passage of stool in a user (The limitation “for the control of passage of stool in a user” is intended use. Since the device of Weitzner is intended for intravaginal placement to control passage of material through a body passage through selectively actuated compression, the device is capable of placement to perform the claimed intended use. See abstract, col. 4, lines 2-12, Figure 4), the device comprising: a body (14, 80, 82) configured for fitting entirely within a vaginal cavity of the user (col. 4, lines 28-34); and an expandable portion (12) coupled to the body, the expandable portion movable between an expanded state and a retracted state (col. 3, lines 3-7 and lines 57-60; Figures 8-9); and an applicator coupled to the body (14, 80, 82) to facilitate insertion of the body into the vaginal cavity of the user (Since the “applicator” is not further structurally defined, the lubricant, which is coupled to the outer surface of “body” 14, 80, 82 during insertion, meets the “applicator” limitation as it is disclosed to aid insertion of the device, col. 5, lines 4-5). It would have been obvious to one of ordinary skill it the art before the effective filing date of the claimed invention to modify the device of Kulick to include an applicator as taught by Weitzner, in order to “aid” insertion of the device into the vaginal cavity for use (Weitzner: col. 5, lines 4-5).
Regarding claims 27 and 35, Kulick teaches all the limitations of claim 21 or 31. Kulick does not specify the expandable portion includes a thickened area configured for contacting the rectovaginal septum of the user.
However, Weitzner teaches an intravaginal device for the control passage of stool in a user (The limitation “for the control of passage of stool in a user” is intended use. Since the device of Weitzner is intended for intravaginal placement to control passage of material through a body passage through selectively actuated compression, the device is capable of placement to perform the claimed intended use. See abstract, col. 4, lines 2-12, Figure 4), the device comprising: a body (14, 80, 82) configured for fitting entirely within a vaginal cavity of the user (col. 4, lines 28-34); and an expandable portion (12) coupled to the body, the expandable portion movable between an expanded state and a retracted state (col. 3, lines 3-7 and lines 57-60; Figures 8-9); the expandable portion (12) includes a thickened area (70) configured for contacting the rectovaginal septum of the user (The limitation “for contacting the rectovaginal septum of the user” is functional language. The device 10 is capable of being placed such that the “thickened area” 70 contacts the rectovaginal septum, Figure 4). 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 expandable portion of Kulick to further include a thickened area as taught by Weitzner in order to “exert concentrated pressure” at the target restrictive area (Weitzner: col. 4, lines 63-66).
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 13 February 2026, with respect to the rejections under 35 U.S.C. 112(a) and 112(b), and the interpretation of certain limitations under 35 U.S.C. 112(f) have been fully considered and are persuasive. The rejections of 29 December 2025 have been withdrawn.
Regarding applicant’s assertion that amending “force-applying portion” to “expandable portion” obviates an interpretation as a means-plus-function limitation under 35 U.S.C. 112(f) as “expandable portion” is a structural term, the examiner agrees with applicant’s interpretation – “expandable portion” in the claims as amended is construed as a structural term.
Applicant’s arguments, see pages 9-11, filed 13 February 2026, with respect to the rejection(s) of claim(s) 21 and its dependents under 35 U.S.C. 102 citing Harmanli have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejections have been withdrawn. However, as necessitated by the amendments to the claims and upon further consideration, a new ground(s) of rejection is made in view of Weitzner and Kulick as these references each better teach and/or suggest applicant’s claimed invention in light of the amendments to the claims.
As noted above, “force-applying portion” has been amended to read --expandable portion--, thus 35 U.S.C. 112(f) is not invoked and the limitation is no longer interpreted in light of its corresponding structure(s) disclosed in the original specification. Accordingly, the scope of claim 31 has been broadened such that prior art applies as detailed above, and consequently the allowability of claims 31-38 has been withdrawn.
Allowable Subject Matter
Claims 22, 25, 26, 32-34, 40, and 41 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
No prior art of record teach and/or fairly suggest the device of claim 22, wherein the expandable portion is configured for moving from the expanded state to the retracted state when the line is pulled away from the body, within the context of all the limitations of parent claim 21.
No prior art of record teach and/or fairly suggest the device of claim 25, wherein the line is configured such that when the line is manipulated, the line causes rotational actuation to move the expandable portion between the expanded state and the retracted state, within the context of all the limitations of parent claim 1.
No prior art of record teach and/or fairly suggest the device of claim 26, comprising a hinge coupling the expandable portion to the body, within the context of all the limitations of parent claim 1.
No prior art of record teach and/or fairly suggest the device of claim 32, comprising: a hinge coupled to this body; and an arm rotatably coupled to the hinge; wherein the arm and the hinge are configured to change a lateral span of the device, within the context of all the limitations of parent claim 31.
No prior art of record teach and/or fairly suggest the device of claim 33, wherein the body comprises a plurality of interlocking teeth that engage to change a lateral span of the device within the context of all the limitations of parent claim 31.
No prior art of record teach and/or fairly suggest the device of claim 34, wherein the expandable portion comprises a magnet and is configured for magnetic actuation to apply pressure to the rectovaginal septum, within the context of all the limitations of parent claim 31.
No prior art of record teach and/or fairly suggest the device of claim 40, wherein the expandable portion is configured to move from the extended state to the nonextended state when the line is pulled away from the body, within the context of all the limitations of claim 31.
No prior art of record teach and/or fairly suggest the device of claim 41, wherein the line is configured such that when the line is manipulated, the line causes rotational actuation of a threaded member to move the expandable portion between the extended state and the nonextended state, within the context of all the limitations of claim 41.
The closest prior art of record, Weitzner and Kulick, respectively, teaches a device as clamed (as detailed above), which does not include a line causing rotational actuation to change the device between its expanded and nonexpanded states, a line configured for changing the device between its expanded and nonexpanded states when the line is pulled away from the device body, a hinge, a magnet for actuation, or interlocking teeth.
Claim 42 is allowed for the reasons noted in the prior Office action.
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 Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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