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 § 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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Forsell(6482145).
Regarding claims 1, 16 and 18, Forsell(6482145) teaches an inflatable member; Note figures 18 and 19 and Col. 16, lines 1-31.
a pump configured to transfer fluid to the inflatable member; and Note figures 18 and 19 and Col. 16, lines 1-31.
a housing operatively coupled to the inflatable member and to the pump, the housing defining a cavity, the housing including a base member disposed within the cavity defined by the housing and a sealing member disposed within the cavity defined by the housing, the sealing member being configured to move with respect to the base member. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. The wall 18 moves relative to the base.
Regarding claim 2, Forsell(6482145) teaches wherein the sealing member is configured to form a fluidic seal with an inner surface of the housing. Note Figures 2A-2D, 3, and 4 and col. 12.
Regarding claims 3 and 19, Forsell(6482145) teaches wherein the housing includes a biasing member disposed within the cavity defined by the housing, the biasing member being disposed between the base member and the sealing member. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. The wall 18 moves relative to the base.
Regarding claim 4, Forsell(6482145) teaches wherein the housing includes a spring member disposed within the cavity defined by the housing, the spring member being disposed between the base member and the sealing member. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. The wall 18 moves relative to the base.
Regarding claim 5, Forsell(6482145) teaches wherein the housing includes a projection extending from an inner surface of the housing. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. The wall 18 moves relative to the base. Note also the locking grooves and projections (7) in figure 4.
Regarding claims 6 and 17, Forsell(6482145) teaches wherein the housing includes a projection extending from an inner surface of the housing and into the cavity defined by the housing, the projection being configured to engage the sealing member. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. The wall 18 moves relative to the base. Note also the locking grooves and projections (7) in figure 4.
Regarding claim 7, Forsell(6482145) teaches wherein the housing includes an adjustment member, the adjustment member being configured to engage the base member. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member.
Regarding claim 8, Forsell(6482145) teaches wherein the housing includes a screw member, the screw member being configured to engage the base member. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. Note specifically figure 3, FIG. 3 is a cross-sectional view of a reservoir 40 defining a chamber 42, the size of which is variable and is controlled by a remote controlled electric motor 44, in accordance with FIG. 1B or 1D. The reservoir 40 and the motor 44 are placed in a housing 46. The chamber 42 is varied by moving a large wall 48. The wall 48 is secured to a nut 50, which is threaded on a rotatable spindle 52. The spindle 52 is rotated by the motor 44 via an angular gearing, which comprises two conical gear wheels 54 and 56 in mesh with each other.
Regarding claim 9, Forsell(6482145) teaches wherein the housing is operatively coupled to the pump via a tubular member. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. Col 3 sets forth, the first and second wall portions of the reservoir may be displaceable relative to each other by manual manipulation, such as by manually pushing, pulling or rotating any of the wall portions in one direction, or alternatively, may be displaceable relative to each other by a device powered magnetically, hydraulically, or electrically (e.g. by an electric motor). The operation device may comprise a fluid conduit, which is devoid of any non-return valve between the pump and the cavity (including the same) and the reservoir may form part of the conduit and a fluid chamber with a variable volume. The pump may distribute fluid from the chamber to the cavity by reduction of the volume of the chamber and withdraw fluid from the cavity by expansion of the volume of the chamber. The operation device preferably comprises a motor for driving the pump, which may comprise a movable wall of the reservoir for changing the volume of the chamber. Any kind of motor could be used for the different operations as well as wireless remote solutions.
Regarding claim 10, Forsell(6482145) teaches wherein the housing is operatively coupled to the inflatable member via a tubular member. Note figures 18 and 19 and Col. 16, lines 1-31.
Regarding claim 11, Forsell(6482145) teaches wherein the inflatable member is configured to be placed near a urethra of a patient. Note figures 18 and 19 and Col. 16, lines 1-31.
Regarding claim 12, Forsell(6482145) teaches wherein the inflatable member is an inflatable cuff member. Note figures 18 and 19 and Col. 16, lines 1-31.
Regarding claim 13, Forsell(6482145) teaches a reservoir, the reservoir being operatively coupled to the housing and being configured to receive fluid. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. The wall 18 moves relative to the base.
Regarding claim 14, Forsell(6482145) teaches a reservoir, the reservoir being operatively coupled to the housing via a tubular member and being configured to receive fluid. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. The wall 18 moves relative to the base.
Regarding claim 15, Forsell(6482145) teaches a reservoir, the reservoir being operatively coupled to the housing and being configured to receive fluid,
the housing including a projection extending from an inner surface of the housing. Note Figures 2A-2D, 3, and 4 and col. 12. Note, figs 2A-2D include a sealing wall member 18, a cavity below the sealing wall portion, and a base or bottom of the housing on which is positioned a spring biasing member. The wall 18 moves relative to the base. Note also the locking grooves and projections (7) in figure 4.
Regarding claim 20, Forsell(6482145) teaches wherein the inflatable member is an inflatable cuff and is configured to be place near and apply pressure to a urethra of a patient. Note figures 18 and 19 and Col. 16, lines 1-31.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Forsell ( US 8287444) teaches A male sexual impotence treatment apparatus comprises an adjustable non-inflatable restriction device (434) implanted in a male impotent patient. The restriction device directly engages a portion of the normal penile tissue of the patient, such as both of the corpora cavernosa as a single unit or one or more of the exit veins from the penis, to affect the blood flow leaving the penis. An adjustment device (436) mechanically adjusts the restriction device to temporarily restrict the blood flow leaving the penis when the patient wishes to achieve erection. The restriction device may comprise an adjustable cuff, a clamp or a roller for bending the vein, corpus cavernosum, crura or the prolongation thereof to restrict the blood flow therein. Such a cuff, clamp or roller may also be utilized for squeezing the vein, corpus cavernosum, crura or the prolongation thereof against human material inside the body of the patient or against implanted structures of the apparatus. The hydraulic operation device may operate the adjustment device with fluid from the reservoir in response to a predetermined first displacement of the first wall portion of the reservoir relative to the second wall portion of the reservoir, to adjust the restriction device to release the tissue, and to operate the adjustment device with fluid from the reservoir in response to a predetermined second displacement of the first wall portion of the reservoir relative to the second wall portion of the reservoir, to adjust the restriction device to restrict the blood flow leaving the penis. In this embodiment, no pump is used, only the volume of the reservoir is varied. This is of great advantage compared to the solution described below when a pump is used to pump fluid between the reservoir and the adjustment device because there is no need for a non-return valve and it is still possible to have fluid going both to and from the reservoir. As an alternative, the hydraulic operation device may comprise a pump for pumping fluid between the reservoir and the adjustment device. The pump may pump fluid both to and away from the adjustment device, or hydraulic means controlling the adjustment device. A mechanical manual solution is proposed in which it is possible to pump in both directions just by pushing an activating member in one direction. Another alternative is a pump pumping in only one direction and an adjustable valve to change the direction of fluid to either increase or decrease the amount of fluid in the reservoir. This valve may be manipulated manually, mechanically, electrically, magnetically, or hydraulically. Any kind of motor could of course be used for all the different operations as well as wireless remote solutions. The pump may comprise a first activation member for activating the pump to pump fluid from the reservoir to the adjustment device and a second activation member for activating the pump to pump fluid from the adjustment device to the reservoir. The activation members may be operable by manual manipulation, preferably to permit manual pushing, pulling or rotating thereof in one direction. Suitably, at least one of the activation members is adapted to operate when subjected to an external pressure exceeding a predetermined magnitude.
Coe et al.( US 8034065) teaches Methods and devices are provided for regulating a hydraulic restriction system. In general, the methods and devices can allow for non-invasive pressure control using a flow control mechanism. The flow control mechanism can be disposed between an implantable restriction device and a fluid source and include an adjustable, variably-sized fluid communication member in fluid communication with the restriction device and the fluid source. The geometry of the fluid communication member can control a rate of fluid flow between the restriction device and the fluid source, thereby also regulating a rate at which a pressure of fluid within the restriction device changes. Alternatively, the fluid flow control mechanism can include a biasing mechanism that can control the rate of fluid flow between the restriction device and the fluid source.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN L CASLER/Primary Examiner, Art Unit 3791