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 .
Specification
The disclosure is objected to because of the following informalities:
“…Apart from pregnancy and childbirth hormonal changes during menopause, obesity, family history of pelvic floor disorders and occupational heavy lifting are risk factors…” in page 1 needs to be corrected. A suggested correction is -- Apart from pregnancy and childbirth, hormonal changes during menopause, obesity, family history of pelvic floor disorders and occupational heavy lifting are risk factors--.
“Further, a shape may be comprised that is like a Zigzag and/or spiral that can be expended by the user and then elastically come back to its compact position” in page 6 needs to be corrected. A suggestion correction is -- Further, a shape may be comprised that is like a Zigzag and/or spiral that can be [[expended]] expanded by the user and then elastically come back to its compact position.--.
“This can communicate to a handheld device and receiving activation and/or de-activation commands from the handheld device” in page 8 needs to be corrected. A suggested correction is -- This can communicate to a handheld device and [[receiving]] receive activation and/or de-activation commands from the handheld device--.
Appropriate correction is required.
The specification lacks any paragraph numbers or line numbers which makes the specification difficult to reference. Use of reference line numbers or paragraph numbers are suggested.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 32 “the open end” needs to be corrected. A suggested correction is – [[the]] an open end – in light of lack of any antecedent for the term “the open end” in claim 32 or base claim 16..
Claim 33 lines 1-2 “A system for alleviating prolapses and/or incontinence, comprising a device for alleviating prolapses and/or incontinence, comprising a support component” needs to be corrected. A suggested correction is --A system for alleviating prolapses and/or incontinence, comprising: a device for alleviating prolapses and/or incontinence, [[comprising]] including: a support component--.
Claim 30 “an anterior end as well as two sides or side ridges) connecting the posterior end and the anterior end” needs to be corrected to -- an anterior end as well as two sides or side ridges[[)]] connecting the posterior end and the anterior end--.
Claim 32 “the connecting component further comprising a releasing valve at the open end that is configured to release fluid when being activated by a user” needs to be corrected. A suggested correction is -- the connecting component further comprising a releasing valve at the open end that is configured to release fluid [[when]] upon being activated by a user -- to avoid conditional limitation recitation which would raise question as to what actually occurs when the condition is not met.
Claim 33 “a controlling component that can be coupled to the device for expanding\” needs to be corrected. A suggested correction is – a controlling component that [[can]] configured to be coupled to the device for expanding —to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “can be” necessarily follows from preceding limitations and thus unclear as to whether this limitation is even required or not required} is even required or not required.
Each of claims 17-30 line 1 needs to be corrected to include a “,” between claim number and wherein term. For example amend claim 17 line 1 “The device according to claim 16 wherein the device” to -- The device according to claim 16, wherein the device--. Similar correction is suggested for claims 17-30.
Claim 32 line 1 “The device according to claim 16, the connecting component further comprising” needs to be corrected. A suggested correction is -- The device according to claim 16, wherein the connecting component further comprising--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 25-30, 32-33 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 25-30 recite the limitation "the body". There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation “the connecting component”. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 in line 6 recites “it” which renders this claim unclear. More specifically, it is unclear as to claim 33 line 6 “it” is referencing which of the preceding structures.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed page 27.
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-22, 24-33 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Enhorning (Pub. No.: US 5007894 A, hereinafter referred to as “Enhorning”).
As per independent Claim 16, Enhorning discloses a device for alleviating prolapses and/or incontinence (Enhorning in at least abstract, fig. 1-4, col. 1 lines 5-11, col. 2 lines 45-65, col. 3 lines 4-6, lines 12-14, lines 25-53, col. 4 lines 5-8, lines 52-68, col. 5, col. 6 lines 17-35 for example discloses relevant subject-matter. More specifically, Enhorning in at least fig. 2, abstract, col. 1 lines 5-11, col. 2 lines 46-50, col. 3 lines 12-14, col. 4 lines 4-8 for example discloses device for alleviating prolapses and/or incontinence. See at least Enhorning col. 3 lines 12-14 “provide a device which will counteract prolapse of the uterus and vagina”; col. 4 lines 4-8 “device …is used in controlling urinary incontinence in women. The device is completely inserted into the vagina for supporting the tissue of the vaginal wall on each side of the upper urethra”), comprising:
a support component, configured to provide at least partial urethral support (Enhorning in at least abstract, fig. 2-4, col. 3 lines 5-7, col. 4 lines 53-54, lines 60-62, lines 68, col. 5 lines 1-2 for example discloses a support component 22, configured to provide at least partial urethral support. See at least Enhorning abstract “female incontinence device inserted into the vagina for supporting the vaginal tissue on each side of the upper urethra”; col. 3 lines 5-7 “a device of such a shape that it will grip to the walls of the vagina”; col. 4 lines 53-54, lines 60-62, lines 68, col. 5 lines 1-2 “device … 22 and includes a body section 24 having the form of a doughnut or ring… projection section, indicated generally at 36, is attached to and is formed as an integral part of body section 24… projections 34 provide support to the tissue of …when device 22 is inserted in the vagina”);
wherein the support component is configured to be inserted into a vagina and to be expandable (Enhorning in at least abstract, fig. 2-4, col. 2 lines 45-50, lines 60-65, col. 3 lines 25-31, col. 5 lines 22-24, lines 41 for example discloses wherein the support component is configured to be inserted into a vagina and to be expandable. See at least Enhorning abstract “device includes an annular inflatable body section …means for inflating and deflating the body section and two projections attached to the body section for supporting the tissue of the vaginal wall lateral and adjacent to each side of the urethra therebetween”; col. 2 lines 45-50, lines 60-65 “an inflatable device which is completely inserted into the vagina and will control female stress incontinence, which device will prevent incontinence… a device which is adjustable by inflation and thereby can be given a large volume and size when inserted but a reduced size during the actual insertion or removal.”; col. 3 lines 25-31 “incontinence device is inserted into the vagina for controlling female stress incontinence. The device includes an annular inflatable body section, means for inflating and deflating the body section and two projections attached to the body section for supporting the vaginal tissue on each side of the upper urethra”; col. 5 lines 22-24, lines 41 “device should be constructed of a material capable of expansion upon air inflation and contraction during deflation…. device 22 is inserted within vagina 10”).
As per dependent Claim 17, Enhorning further discloses the device according to claim 16 wherein the device comprises a posterior end and an anterior end with two sides connecting the posterior end and the anterior end (Enhorning, fig. 3-4, col. 3 lines 27 “incontinence device is inserted into the vagina for controlling female stress incontinence. The device includes an annular inflatable body section” , col. 4 lines 52-54 “device … 22 and includes a body section 24 having the form of a doughnut or ring”).
As per dependent Claim 18, Enhorning further discloses device wherein the anterior end is thicker and/or has a larger cross-section than the posterior end and wherein the anterior end is configured to support and/or compress a urethra from a vaginal side (Enhorning abstract, fig. 3-4, col. 3 lines 25-30, Col. 4 lines 60-63, lines 68, col. 5 lines 1-2, lines 15-17 for example discloses the anterior end at 36 is thicker and/or has a larger cross-section than the posterior end and wherein the anterior end is configured to support and/or compress a urethra from a vaginal side. See at least col. 3 lines 25-30 “incontinence device is inserted into the vagina for controlling female stress incontinence. The device includes an annular inflatable body section…and two projections attached to the body section for supporting the vaginal tissue on each side of the upper urethra”; Col. 4 lines 60-63 and col. 5 lines 1-2 “projection section, indicated generally at 36, is attached to and is formed as an integral part of body section 24 and includes two anterior projections 34 spaced along external surface 28 of body section 24… projections 34 provide support to the tissue of the anterior vaginal wall 38 (FIG. 4) on each side of the urethra 18 when device 22 is inserted in the vagina”; col. 5 lines 15-17 “material should include characteristics which will … provide the required support to the tissue of the anterior vaginal wall 38 on each side of the urethra 18”) and the posterior end and the sides are configured to support the device in other parts of the vagina(Enhorning col. 3 lines 12-14 “provide a device of such a shape that it will grip to the walls of the vagina”; col. 5 lines 15-17 “material should include characteristics which will … provide the required support to the tissue of the anterior vaginal wall 38 on each side of the urethra 18”).
As per dependent Claim 19, Enhorning further discloses device wherein the device comprises at least one expandable volume (Enhorning fig. 3-4, abstract “inflatable body section”; col. 3 lines 25-30 “device includes an annular inflatable body section”).
As per dependent Claim 20, Enhorning further discloses device wherein the device comprises at least one inflatable chamber(Enhorning fig. 3-4, abstract “inflatable body section”; col. 3 lines 25-30 “device includes an annular inflatable body section, means for inflating and deflating the body section ”).
As per dependent Claim 21, Enhorning further discloses the device wherein the device comprises at least one inflatable chamber within an anterior end and two sides of the device (Enhorning fig. 3-4, abstract “inflatable body section”; col. 3 lines 25-30 “device includes an annular inflatable body section, means for inflating and deflating the body section”).
As per dependent Claim 22, Enhorning further discloses device wherein the inflatable chamber is provided in each side and an anterior end of the device (Enhorning fig. 3-4, abstract “inflatable body section”; col. 3 lines 25-30 “device includes an annular inflatable body section, means for inflating and deflating the body section”).
As per dependent Claim 24, Enhorning further discloses device wherein the support component comprises a body (fig. 2-4 col. 4 lines 52-57 “device …indicated generally at 22 and includes a body section 24 …Body section 24 defines a roughened surface 28 on the axially exterior portion thereof and an axially inner surface 30”; col. 5 lines 12-17 “material should include characteristics which will readily … provide the required support to the tissue of the anterior vaginal wall 38 on each side of the urethra 18”).
As per dependent Claim 25, Enhorning further discloses device wherein the body comprises a generally torus shape (Enhorning, fig. 3-4).
As per dependent Claim 26, Enhorning further discloses device wherein the body comprises a generally toroidal shape (Enhorning, fig. 3-4).
As per dependent Claim 27, Enhorning further discloses device wherein the body comprises an oval ring shape (in use Enhorning fig. 2 appears oval ring shaped in x-section).
As per dependent Claim 28, Enhorning further discloses device wherein the body comprises an elliptical ring shape (in use Enhorning fig. 2 appears elliptical ring shaped in x-section).
As per dependent Claim 29, Enhorning further discloses device wherein the body comprises an ovoid shape (in use Enhorning fig. 2 body 22 comprises an ovoid shape).
As per dependent Claim 30, Enhorning further discloses device wherein the body comprises a posterior end, an anterior end as well as two sides or side ridges) connecting the posterior end and the anterior end (Enhorning fig. 3-4 for example discloses the body 24 comprises a posterior end, an anterior end as well as two sides or side ridges connecting the posterior end and the anterior end).
As per dependent Claim 31, Enhorning further discloses device further comprising a connecting component for connecting the device with a source of fluid and/or a controlling component for delivering or releasing fluid (Enhorning abstract, fig. 3, col. 5 lines 22-40 for example discloses a connecting component 43 for connecting the device 22 with a source of fluid and/or a controlling component for delivering or releasing fluid. See at least Enhorning abstract “device includes an annular inflatable body section … means for inflating and deflating the body section …inflating and deflating means includes a tubing extending from the body section, and a valve housed within the tubing for regulating the flow of air into and out of the body section”; col. 5 lines 22-40 “device should be constructed of a material capable of expansion upon air inflation and contraction during deflation. With reference to FIG. 3, an inflation means, indicated generally at 43, is provided. The inflation means is operated by a syringe or a pump (not shown) and includes a tubing 44 connected to body section 24 at circumferential surface 30 and a one-way ball valve 46… It is understood, that any sufficient method of inflating and deflating body section 24 can be substituted herein”).
As per dependent Claim 32, Enhorning further discloses device the connecting component further comprising a releasing valve at the open end that is configured to release fluid when being activated by a user (Enhorning abstract, fig. 3, col. 5 lines 22-40 for example discloses the connecting component 43 further comprising a releasing valve at the open end that is configured to release fluid when being activated by a user. See at least Enhorning abstract “device includes an annular inflatable body section … means for inflating and deflating the body section …inflating and deflating means includes a tubing extending from the body section, and a valve housed within the tubing for regulating the flow of air into and out of the body section”; col. 5 lines 22-40 “device should be constructed of a material capable of expansion upon air inflation and contraction during deflation. With reference to FIG. 3, an inflation means, indicated generally at 43, is provided…For deflation, the valve 46 can be opened by digital compression carried out by an attendant or by the patient herself. It is understood, that any sufficient method of inflating and deflating body section 24 can be substituted herein).
As per independent Claim 33, Enhorning discloses a system for alleviating prolapses and/or incontinence (Enhorning in at least abstract, fig. 1-4, col. 1 lines 5-11, col. 2 lines 45-65, col. 3 lines 4-6, lines 12-14, lines 25-53, col. 4 lines 5-8, lines 52-68, col. 5, col. 6 lines 17-35 for example discloses relevant subject-matter. More specifically, Enhorning in at least fig. 3-4, abstract, col. 1 lines 5-11 for example discloses system for alleviating prolapses and/or incontinence. See at least Enhorning abstract “female incontinence device inserted into the vagina for supporting the vaginal tissue on each side of the upper urethra … device includes an annular inflatable body section…, means for inflating and deflating the body section and two projections attached to the body section for supporting the tissue of the vaginal wall lateral and adjacent to each side of the urethra therebetween. The inflating and deflating means includes a tubing extending from the body section, and a valve housed within the tubing for regulating the flow of air into and out of the body section”), comprising a device for alleviating prolapses and/or incontinence (Enhorning in at least fig. 2, abstract, col. 1 lines 5-11, col. 2 lines 46-50, col. 3 lines 12-14, col. 4 lines 4-8 for example discloses device (fig. 3-4) for alleviating prolapses and/or incontinence. See at least Enhorning col. 3 lines 12-14 “provide a device which will counteract prolapse of the uterus and vagina”; col. 4 lines 4-8 “device …is used in controlling urinary incontinence in women. The device is completely inserted into the vagina for supporting the tissue of the vaginal wall on each side of the upper urethra”), comprising
a support component, configured to provide at least partial urethral support(Enhorning in at least abstract, fig. 2-4, col. 3 lines 5-7, col. 4 lines 53-54, lines 60-62, lines 68, col. 5 lines 1-2 for example discloses a support component 22, configured to provide at least partial urethral support. See at least Enhorning abstract “female incontinence device inserted into the vagina for supporting the vaginal tissue on each side of the upper urethra”; col. 3 lines 5-7 “a device of such a shape that it will grip to the walls of the vagina”; col. 4 lines 53-54, lines 60-62, lines 68, col. 5 lines 1-2 “device … 22 and includes a body section 24 having the form of a doughnut or ring… projection section, indicated generally at 36, is attached to and is formed as an integral part of body section 24… projections 34 provide support to the tissue of …when device 22 is inserted in the vagina”);
wherein the support component is configured to be inserted into a vagina and to be expandable(Enhorning in at least abstract, fig. 2-4, col. 2 lines 45-50, lines 60-65, col. 3 lines 25-31, col. 5 lines 22-24, lines 41 for example discloses wherein the support component is configured to be inserted into a vagina and to be expandable. See at least Enhorning abstract “device includes an annular inflatable body section …means for inflating and deflating the body section and two projections attached to the body section for supporting the tissue of the vaginal wall lateral and adjacent to each side of the urethra therebetween”; col. 2 lines 45-50, lines 60-65 “an inflatable device which is completely inserted into the vagina and will control female stress incontinence, which device will prevent incontinence… a device which is adjustable by inflation and thereby can be given a large volume and size when inserted but a reduced size during the actual insertion or removal.”; col. 3 lines 25-31 “incontinence device is inserted into the vagina for controlling female stress incontinence. The device includes an annular inflatable body section, means for inflating and deflating the body section and two projections attached to the body section for supporting the vaginal tissue on each side of the upper urethra”; col. 5 lines 22-24, lines 41 “device should be constructed of a material capable of expansion upon air inflation and contraction during deflation…. device 22 is inserted within vagina 10”; and
a controlling component that can be coupled to the device for expanding it (Enhorning abstract, fig. 3, col. 5 lines 22-40 for example discloses a controlling component/inflating and deflating means that can be coupled to the device for expanding it. See at least Enhorning abstract “device includes an annular inflatable body … means for inflating and deflating the body section … inflating and deflating means includes a tubing extending from the body section, and a valve housed within the tubing for regulating the flow of air into and out of the body section.”; col. 5 lines 22-40 “device should be constructed of a material capable of expansion upon air inflation and contraction during deflation. With reference to FIG. 3, an inflation means, indicated generally at 43, is provided. The inflation means is operated by a syringe or a pump (not shown) and includes a tubing 44 connected to body section 24 at circumferential surface 30 and a one-way ball valve 46…For deflation, the valve 46 can be opened by digital compression carried out by an attendant or by the patient herself. It is understood, that any sufficient method of inflating and deflating body section 24 can be substituted herein and still be within the scope of the present invention”).
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Enhorning in view of Ziv et al. (Pub. No.: US 20090266367 A1, hereinafter referred to as “Ziv”).
As per dependent Claim 23, Enhorning discloses device according to claim 16 (see claim 16 above).
Enhorning does not explicitly disclose or require the three inflatable chambers feature.
However, in an analogous device for alleviating prolapses and/or incontinence field of endeavor, Ziv discloses a device for alleviating prolapses and/or incontinence (Ziv in at least fig. 16-17, abstract, [0012], [0060], [0295-0308] for example discloses relevant subject-matter. More specifically, Ziv in at least fig. 17A, [0012], [0060], [0174] for example discloses inflatable device for alleviating prolapses and/or incontinence. See at least Ziv [0012] “a device for supporting a prolapsed organ, the device including a ring-like body having a naturally occurring substantially flat and substantially planar compact configuration, the ring-like body configured with a size suitable for insertion into a vagina and to be expanded by a support element such that in the expanded configuration an outer periphery of the ring-like body contacts a portion of the vagina and stretches at least a portion of a prolapsed vaginal wall thereby substantially alleviating prolapse of at least one pelvic organ… includes a support element including …moveably connected arms configured to support the ring in the expanded configuration”)
wherein the device comprises three inflatable chambers, one in each one of two sides and one in an anterior end (Ziv, [0060], [0174] for example discloses the device comprises three inflatable chambers, one in each one of two sides in the form of inflatable/chambered arms and one in an anterior end as part of the inflatable pessary body chamber at anterior end. See at least Ziv [0174]“ an inflatable pessary for supporting a prolapsed organ. The inflatable pessary includes an inflatable chamber having at least two inflatable arms, the inflatable chamber having at least two configurations: an uninflated configuration having a size suitable for insertion into a vagina; and an inflated configuration in which at least a portion of the inflatable chamber contacts a portion of the vagina, and supports at least a portion of a prolapsed organ”).
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 inflatable chamber used in the device for alleviating prolapses and/or incontinence as taught by Enhorning, such that device comprises three inflatable chambers, one in each one of two sides and one in an anterior end, as taught by Ziv as a matter of making separable what is disclosed as integral in applied prior art (see MPEP 2144.04). A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of selectively inflating the different chambers of the inflatable device to derive a pessary device with an inflatable body having an expanded configuration such that an outer periphery of the body contacts a portion of the vagina and stretches at least a portion of a vaginal wall, thereby substantially alleviating and effectively treating prolapse of the pelvic organ (Ziv, abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art GB 2352181 A to Stimpson discloses an inflatable pessary adapted to be placed in the female vagina to prevent or reduce the effects of incontinence similar to that disclosed. More specifically, Stimpson discloses an inflatable pessary adapted to be placed in a female vagina comprising elongate support means, inflatable restriction means being connected to the support means, and an inflation valve located remote from said inflatable restriction means, wherein the restriction means is arranged such that when inflated, pressure is applied outwardly to the walls of the vagina. The pessary may also include a second inflatable restriction means where the restriction means may be independently deflated and inflated. The pessary may be used to provide artificial continence, to conduct perineometry or to provide sexual stimulation.
Prior art US 5603685 A to Tutrone discloses an inflatable vaginal pessary suitable for treating urinary incontinence and uterine prolapse similar to that disclosed and claimed. More specifically, Tutrone discloses pessary device, comprising a first inflatable chamber adapted to fit in the vestibule of the vaginal cavity of a human when inflated, wherein the chamber compresses the urethra of the human when inflated; an anchor member adapted to snugly fit in the vaginal cavity, the anchor member being connected to the inflatable chamber on the posterior side of the chamber when the pessary is in its normal operating position; and an inflation tube having a first end fluidly connected to the inflatable chamber and a second end connected to an inflation valve located external to the vagina when the pessary device is in its normal operating position that permits inflation and deflation of the inflatable chamber without disturbing the fit of the anchor member.
Prior art US 4669478 A to Robertson discloses inflatable elongate pessary that fits into and distends the patient's vagina and with it the urethra similar to that disclosed and claimed. More specifically, Robertson discloses inflatable elongate pessary fits into and longitudinally distends the patient's vagina and with it the urethra. An indentation near the proximal end of the pessary receives the patient's cervix so that the pessary can extend into and distend the most proximal region behind the cervix. Preferably a lateral enlargement near the distal end of the pessary aids in supporting the pessary above the levator ani sling. The pessary moves the bladder neck and the proximal portion of the urethra toward normal positions above the abdominal wall. The pessary includes a flexible airtight chamber, and a valve and fitting that are operable from outside the vagina while the pessary is inside. The fitting is accessible from the outside for attachment of a source of compressed gas, while the pessary is in the vagina. Within the pessary is preferably a longitudinal cavity, open at the distal end of the pessary but extending near the proximal end; the patient can insert a finger into this cavity to push the pessary all the way up into the vagina.
Prior art US 20230233361 A1 to Notten et al. discloses a vaginal device for pelvic organ prolapse treatment similar to that disclosed. More specifically, Notten discloses Vaginal device for pelvic organ prolapse treatment, having an elongated base element, an inflatable element attached to a distal end part of the elongated base element, and a support element attached to a proximal end part of the elongated base element. The support element has at least two support members, which extend away from the proximal end of the elongated base element. The at least two support elements are arranged to support lower parts of prolapsed compartments, and the support element comprises an adjustable connector for fixing the position of the support element along the proximal end part of the elongated base element.
Prior art US 20180132991 A1 to Bercovich et al. discloses devices that are inserted into the vagina and are activated by intra vaginal, intra-abdominal or contraction of the pelvic floor muscles to create a transient pressure on the urethra for treating urinary incontinence in females similar to that disclosed. More specifically, Bercovich discloses an intra-vaginal device for controlling urinary incontinence, designed to be placed longitudinally in the vagina, includes: a. a deformable distal portion, placed in the subvesical region of the vagina, characterized by a deformable state and an un-deformable state; b. a deformable proximal portion placed in the sub-urethral portion of the vagina, characterized by a deformable state and an un-deformable state; c. a deformation controlling mechanism interconnecting said distal portion and said proximal portion, adapted to reversibly transform said distal portion and said proximal portion form said deformable state to said un-deformable state; and from said un-deformable state to said deformable state; wherein upon predetermined amount of intra-vaginal pressure applied on said proximal pressure, said deformation controlling mechanism is adapted to transform proximal portion from said un-deformable state to said deformable state such that pressure is applied on said urethra.
Prior art US 20160374788 A1 to Ramachandra et al. discloses pessary devices for relief of female incontinence similar to that disclosed. More specifically, Ramachandra discloses intravaginal pessary device in an applicator. The device has a top and a bottom, and a sidewall that extends between the top and the bottom. The sidewall, top and bottom form an outer periphery defining a total area of the device.
Prior art US 20100305395 A1 to Spitz et al. discloses devices for treating stress incontinence similar in terms of the resulting therapeutic effect to that disclosed. More specifically, Spitz discloses devices for treating stress incontinence, having a horizontal proximal portion supported on the pubococcygeus muscle and a distal portion extending downward and away from the proximal portion at an angle approximating the vagina in an erect female as it passes down and between the anterior segments of the pubococcygeus. The distal portion may terminate with a protrusion that is positioned to provide midurethral support, thereby preserving the urethovesical angle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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