DETAILED ACTION
This action is in response to the Preliminary Amendment filed 8/14/2024. Currently, claims 1-15 are pending in the application.
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
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract includes legal phraseology, which is not permitted. The term “comprises” should be removed from the abstract to avoid this error. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: the specification teaches “ribs 112” and “walls 112,” making it unclear what single structure reference character “112” is intended to correspond to.
Appropriate correction is required.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities: in order to improve the clarity of the claim(s), all recitations of “the interior” should be amended to recite ---the interior of the elongate body---. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “when deformed” in line 2 of the claim should be amended to recite ---when deformed in use---. 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.
Claim 6 is 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 6 recites the limitation "the at least one rib" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-7 and 10-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simon et al. (US 5,090,424 A).
In regards to claim 1, Simon et al. teaches in Figures 1 and 2, claim 1, column 4, lines 43-44 and 64-65 and column 5, lines 9-16 an elongate body (urethral plug 10; shown in Figure 1 to have an elongate structure) having a closed end (proximal end 15; shown in Figure 1 to be closed off and bounded by material), an inflation end (the end of urethral plug 10 at location 14; positioned adjacent bellows 11, which is taught in column 5, lines 9-16 to be used to inflate the urethral plug 10), and at least one deformable wall (wall of the proximal end 15 of the urethral plug 10; column 5, line 16 teaches “the wall of the plug;” Figures 1 and 2 teach that the wall of the proximal end 15 of the urethral plug 10 is capable of deforming by expanding; claim 1 teaches “an expandable housing forming a plug portion”) therebetween (Figure 1 teaches the wall of the proximal end 15 of the urethral plug 10 extending between proximal end 15 and the end of urethral plug 10 at location 14); an interior (interior surface of urethral plug 10) within (as shown in Figure 1) the elongate body (urethral plug 10) is configured to hold an air pressure (Figure 1 teaches the urethral plug 10 containing fluid 33; column 5, lines 14-16 teaches “the fluid 32 is transported to cavity 23 located within plug 10 becoming fluid 33;” column 4, lines 43-44 teaches “the hollow inner core is filled with a fluid, however, it can be air;” column 4, lines 64-65 teaches “air can be employed as the fluid”); and an air valve (check valve 22) extending from an exterior (within bellows 11) of the elongate body (urethral plug 10) to the interior (as shown in Figure 1).
In regards to claim 2, Simon et al. teaches the apparatus of claim 1. Simon et al. teaches in column 1, lines 9-10 and column 4, lines 47-48 that the at least one deformable wall (wall of the proximal end 15 of the urethral plug 10) forms at least one seal with the penis (by blocking the urethra; column 1, lines 9-10 teaches that the device can be used with male patients; thus, the device can be inserted into a male urethra, which is located inside the penis) when deformed (column 4, lines 47-48 teaches “the inflated sack forms a plug by blocking the passage in the urethra”).
In regards to claim 3, Simon et al. teaches the apparatus of claim 1. Simon et al. teaches in Figure 1 that the elongate body (urethral plug 10) is cylindrical when deflated (as shown in Figure 1).
In regards to claim 4, Simon et al. teaches the apparatus of claims 1 and 3. Simon et al. teaches in Figures 1 and 2 that the interior (interior surface of urethral plug 10) within the elongate body (urethral plug 10) varies in diameter along (Figure 1 teaches that the diameter of the interior surface of urethral plug 10 narrows from left to right along the longitudinal axis of the urethral plug 10) an axis (longitudinal axis) of the elongate body (urethral plug 10) to form (by allowing increased inflated at the proximal end 15; column 5, lines 18-21 teaches “the wall thickness varies from the meatal plate 13, beginning at location 14 to the proximal end 15 where the wall is thinnest, allowing the greatest inflation”) the at least one deformable wall (wall of the proximal end 15 of the urethral plug 10) and at least one rib (wall(s) of the urethral plug 10 extending between the proximal end 15 and meatal plate 13).
In regards to claim 5, Simon et al. teaches the apparatus of claims 1, 3 and 4. Simon et al. teaches in Figure 2 that the at least one rib (wall(s) of the urethral plug 10 extending between the proximal end 15 and meatal plate 13) varies in diameter around a circumference of (Figure 2 teaches that the wall(s) of the urethral plug 10 extending between the proximal end 15 and meatal plate 13 expands outward and increases diameter adjacent the proximal end 15) the interior (interior surface of urethral plug 10) of the elongate body (urethral plug 10).
In regards to claim 6, Simon et al. teaches the apparatus of claims 1 and 3. Simon et al. teaches in Figure 2 that the at least one rib (wall(s) of the urethral plug 10 extending between the proximal end 15 and meatal plate 13) slopes in an increasing diameter to (Figure 2 teaches that the wall(s) of the urethral plug 10 extending between the proximal end 15 and meatal plate 13 slopes upward to increase diameter adjacent the proximal end 15) the at least one deformable wall (wall of the proximal end 15 of the urethral plug 10).
In regards to claim 7, Simon et al. teaches the apparatus of claim 1. Simon et al. teaches in Figure 1 a protrusion (meatal plate 13; shown in Figure 1 to project inward toward the check valve 22 and outward away from the perimeter of the urethral plug 10) on (Figure 1 teaches the meatal plate 13 being attached to a positioned on the interior surface of urethral plug 10) the interior (interior surface of urethral plug 10) of the elongate body (urethral plug 10); and the protrusion (meatal plate 13) surrounds an orifice of (as shown in Figure 1) the air valve (check valve 22).
In regards to claim 10, Simon et al. teaches the apparatus of claim 1. Simon et al. teaches in Figure 1 a cap (bellows 11) to cover (Figure 1 teaches the bellows 11 extending over and covering the check valve 22) the air valve (check valve 22).
In regards to claim 11, Simon et al. teaches the apparatus of claims 1 and 3. Simon et al. teaches in Figure 2 that the interior (interior surface of urethral plug 10) comprises at least two chambers (portion of the hollow interior of urethral plug 10 defined in the annotated copy of Figure 2 provided below) with at least one passage (portion of the hollow interior of urethral plug 10 defined in the annotated copy of Figure 2 provided below) therebetween (as shown in Figure 2).
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In regards to claim 12, Simon et al. teaches the apparatus of claim 1. Simon et al. teaches in Figure 1 that the closed end (proximal end 15) has a rounded outer surface (Figure 1 teaches the proximal end 15 being rounded).
In regards to claim 13, Simon et al. teaches the apparatus of claim 1. Simon et al. teaches in the abstract and column 6, lines 36-42 that the elongate body (urethral plug 10) comprises at least one of: a rubber (column 6, lines 36-42 teaches the urethral plug being formed by molding and “curing of the rubber”), a latex, and a flexible plastic (the abstract teaches “a flexible urethral plug” that is formed from “molded soft inflatable plastic”).
In regards to claim 14, Simon et al. teaches the apparatus of claim 1 as discussed above. Simon et al. teaches in column 1, lines 9-10, column 4, lines 20-22, 39-44 and 64-68 and column 5, lines 9-11 and 14-16 inserting the elongate body (urethral plug 10) into a urethra of the penis by the closed end (proximal end 15) (column 4, lines 20-22 teaches “the urethral plug, which is the subject of this invention, is a soft, flexible device which is inserted into the patient's urethra;” column 1, lines 9-10 teaches that the device can be used with a male urethra, which is located inside the penis; column 4, lines 39-42 teaches “the device is inserted into the urethra, so that the inflatable balloon is left outside the body, and the sack into inserted into the urethra, remains in bladder neck or bladder”); inserting a nozzle of a pump into (column 4, lines 66-68 teaches “the device may be a combination of disposable and reusable parts and can be inflated by an external pump”) the air valve (check valve 22); pumping air (column 4, lines 66-68 teaches “the device may be a combination of disposable and reusable parts and can be inflated by an external pump;” column 5, lines 14-16 teaches “the fluid 32 is transported to cavity 23 located within plug 10 becoming fluid 33;” column 4, lines 43-44 teaches “the hollow inner core is filled with a fluid, however, it can be air;” column 4, lines 64-65 teaches “air can be employed as the fluid”) through (column 5, lines 9-11 teaches “bellows 11 defines cavity 21, and is used to transport fluid 32 contained in cavity 21 through a check valve 22”) the air valve (check valve 22) thereby increasing the air pressure within (column 5, lines 14-16 teaches “the fluid 32 is transported to cavity 23 located within plug 10 becoming fluid 33”) the interior (interior surface of urethral plug 10) of the elongate body (urethral plug 10); and removing the nozzle (column 4, lines 66-68 teaches “the device may be a combination of disposable and reusable parts and can be inflated by an external pump;” it is understood that the external pump is removed after functioning for inflation) from the air valve (check valve 22) thereby sealing the interior (interior surface of urethral plug 10) of the elongate body (urethral plug 10).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 5,090,424 A) in view of Bercovich (US 2014/0243584 A1).
In regards to claim 8, Simon et al. teaches the apparatus of claim 1. Simon et al. teaches in the abstract that the at least one deformable wall (wall of the proximal end 15 of the urethral plug 10) is formed of a flexible material (the abstract teaches “a flexible urethral plug;” the material of the urethral plug 10 includes the wall of the proximal end 15 of the urethral plug 10).
Simon et al. does not teach a stiff material between each of the at least one deformable wall.
However, Bercovich teaches in [0097] an analogous device with a stiff material (at rigid end 142a) between each of the at least one deformable wall (remaining, more flexible portions of second balloon 142).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the at least one deformable wall of Simon et al. to include a stiff material between each of the at least one deformable wall as taught by Bercovich because this element is known to enable “directional inflation of the second balloon 142,” as Bercovich teaches in [0097]. This directional inflation enables the at least one deformable wall to be supported in a contour that is for comfortable positioning within the urethra.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 5,090,424 A) in view of Benderev (US 6,110,099 A).
In regards to claim 9, Simon et al. teaches the apparatus of claim 1. Simon et al. does not teach an isolated chamber configured to house a vibrator.
However, Benderev teaches in Figure 5 an analogous device with an isolated chamber (stimulus producing device 26; shown in Figure 5) configured to house a vibrator (column 8, lines 26-27 teaches “such stimulus producing device 26 may take the form of a vibrator”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the device of Simon et al. to include an isolated chamber configured to house a vibrator as taught by Benderev because this element is known “to provide a signal to the user to perform pelvic strengthening exercises,” as Benderev teaches in the abstract.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 5,090,424 A) in view of ACKERMAN (US 2021/0378810 A1).
In regards to claim 15, Simon et al. teaches the method of claim 14. Simon et al. teaches in column 1, lines 9-10, column 4, lines 43-44, column 4, lines 64-65 and column 6, lines 13-16 releasing the air pressure (column 4, lines 43-44 teaches “the hollow inner core is filled with a fluid, however, it can be air;” column 4, lines 64-65 teaches “air can be employed as the fluid”) from within the interior (interior surface of urethral plug 10) of the elongate body (urethral plug 10); and removing the elongate body (urethral plug 10) from the urethra of the penis (column 6, lines 13-16 teaches “for removal, bellows 11 is gently tugged on by the patient so that the expanded proximal end 15 deflates, thereby allowing urethral plug 10 to be easily removed from the urethra 41;” column 1, lines 9-10 teaches that the device can be used with a male urethra, which is located inside the penis).
Simon et al. does not teach reinserting the nozzle into the air valve.
However, ACKERMAN teaches in [0092] an analogous method that includes reinserting the nozzle (of the pump) into the air valve ([0092] teaches “inflation means 120 (not shown in FIG. 1B) may also act as deflation means, such that inflation means 120, which may be a syringe, or a pump, may be attached to port 150 and may, in reverse action to when inflating body 100, draw gas from cavity 160, via exhaust valve 134, through core 130 and out of port 150”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the method of Simon et al. to include reinserting the nozzle into the air valve as taught by ACKERMAN because this element is known to facilitate deflation of the elongate body using the pump, as ACKERMAN teaches in [0092].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 9/18/2025