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 .
Election/Restrictions
Applicant’s election without traverse of Group ( I) claims (1-16) is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 22, 2025.
Claim Objections
Claims 3-5 and 8 are objected to because of the following informalities:
Regarding claims 3-5, line 1, “has second end” should be –has a second end--.
Regarding claim 8, line 5, “a distance the location along the tubular member” is unclear, perhaps it should be -- a distance from the location along the tubular member--.
Appropriate correction is required.
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) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Little(US20130190559) hereinafter Little.
Little teaches An implantable penile prosthesis having an inflatable cylinder with at least one piezoelectric pump for transferring fluid between an integrated reservoir and pressure chamber within the inflatable cylinder.
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Regarding claim 1, Little teaches a fluid reservoir defining a cavity;
an inflatable member;
a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member; and
a tubular member extending between the fluid reservoir and the pump assembly, the tubular member having a first end that is disposed within the cavity defined by the fluid reservoir. Note Figs. 1-2, paragraph [0016]: [0016] As shown in FIG. 1, an implantable penile prosthesis 2 ("IPP"), according to an embodiment of the present invention, comprises at least one inflatable cylinder 4 implantable within the corpus cavernosum. Each inflatable cylinder 4 comprises an elongated cylindrical body defining a fluid reservoir 6 at one end and an expandable pressure cylinder 8 positioned opposite the fluid reservoir 6. Each inflatable cylinder 4 further comprises an inflation system 10 operably linking the fluid reservoir 6 to the expandable pressure cylinder 8. [0017]: “…The second septum 16 can further comprise a rod 24 extending through the second septum 16 and defining a channel 26 providing a fluid communication between the pump cavity 20 and the fluid reservoir 6…”. Note rod 24 extends into the fluid reservoir 6.
Regarding claim 2, Little teaches wherein the tubular member is operatively coupled to the fluid reservoir. Note Figs. 1-2, paragraph [0016] and [0017].
Regarding claims 3-5 , Little teaches wherein the tubular member has second end, the tubular member being operatively coupled to the fluid reservoir at a location along the tubular member, the location being disposed between the first end of the tubular member and the second end of the tubular member and wherein the tubular member has second end, the tubular member being operatively coupled to the fluid reservoir at a location along the tubular member, the location being disposed between the first end of the tubular member and the second end of the tubular member, the location being spaced from the first end of the tubular member, and wherein the tubular member has second end, the tubular member being operatively coupled to the fluid reservoir at a location along the tubular member, the location being disposed between the first end of the tubular member and the second end of the tubular member, the location being spaced from the second end of the tubular member.
Note Figs. 1-2, paragraph [0016] and [0017]. Also note tube 24 extends from a first end in the reservoir 6 to a second end in the pump system 10 and is operatively coupled to the fluid reservoir at a location that is a distance from both the first end and the second end.
Regarding claim 6, Little teaches wherein the fluid reservoir is configured to retain fluid within the cavity defined by the fluid reservoir. Note Figs. 1-2, paragraph [0016] and [0017].
Regarding claims 7-8 , Little teaches wherein the fluid reservoir is configured to retain fluid within the cavity defined by the fluid reservoir, the first end of the tubular member being disposed within the cavity defined by the fluid reservoir such that it is configured to contact fluid that is disposed a distance from a sidewall of the reservoir, and wherein the fluid reservoir is configured to retain fluid within the cavity defined by the fluid reservoir, the tubular member being operatively coupled to the reservoir at a location along the tubular member, the first end of the tubular member being disposed within the cavity defined by the fluid reservoir such that it is configured to contact fluid that is disposed a distance the location along the tubular member. Note Figs. 1-2, paragraph [0016] and [0017]. Also note, rod 24 contacts fluid within reservoir 6 that is disposed a distance from a sidewall of the reservoir and fluid that is disposed a distance the location along the tubular member.
Claim(s) 10-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by George et al.(US20050113639) hereinafter George et al.
George et al. teaches fluid reservoir for a penile implant device that includes a body portion having a sleeve from which a tube may extend. The body portion includes support structure positioned at an interior surface of the body portion near an orifice of the reservoir, which orifice leads to a fluid passage of the tube. The support structure may comprise a plurality of protrusions that are arranged around the orifice and that extend from a base portion of the body portion. [0034] The device 10 generally includes first and second inflatable penile cylinders 12 and 14, respectively, a pump 16, and a reservoir 18 in accordance with the present invention. The first penile cylinder 12 is fluidly coupled to the pump 16 by a tube 20 and the second penile cylinder 14 is fluidly coupled to the pump 16 by a tube 22. The pump 16 is fluidly coupled to the reservoir 18 by a tube 24.
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Regarding claim 10, George et al. teaches a fluid reservoir having a sidewall defining a cavity and an extension member extending from the sidewall into the cavity defined by the fluid reservoir;
an inflatable member;
a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member; and
a tubular member extending between the fluid reservoir and the pump assembly. Note figs. 1-3, paragraph [0035]: [0035] FIGS. 2 and 3 show one embodiment of the reservoir 18 of the present invention, which generally includes a shell 26 having an interior space 28 and an adapter 34 extending from the shell 26. Tube 24 is shown as extending from the adapter 34, although the tube 24 is not the only type of device that can extend from the reservoir 18 for fluid communication between the reservoir 18 and other adjacent devices or components. For example, additional or different adapters or devices may be connected directly to one end of the adapter 34, in which case any tubing used may optionally be attached to the configuration at some other point distal from the shell 26 and adapter 34. In cases where such a tube 24 is used, however, the tube 24 preferably includes an inner fluid passage 36 extending along its length through which fluid can move to and from the shell 26. Preferably, the tube 24 is a separate component that is sealed to the adapter 34 during a molding process as described below. However, the tube 24 may be molded as part of the adapter 34 or otherwise fused or bonded to the sleeve 25 of the adapter 34 with an appropriate technique. Paragraph [0036]: [0036] Further, the adapter 34 may include an annular flange 40 adjacent the shell 26, and a sleeve 25 spaced from the shell 26, where the tube 24 may be attached to the adapter 34 at sleeve 25. The adapter 34 preferably includes an opening 27 adjacent to the fluid passage 36 that is configured to provide fluid communication between the tube 24 and the inner area of the annular flange 40. Thus, the opening 27 is preferably the same shape and size as the fluid passage 36 to allow fluid to move to and from the interior space 28 of shell 26 without fluid leakage between the components and to further allow fluid to move from the interior space 28 of the shell 26, through fluid passage 36, and to other components to which the tube 24 is attached. For example, referring to the exemplary device 10 of FIG. 1, the reservoir 18 can provide fluid to the pump 16 via tubing 24, and the pump can subsequently transfer fluid to and from the penile cylinders 12 and 14. Note paragraph [0037] “…In addition, the inside surface 46 of the flange 40 may also be adhered to the portion of the shell 26 beyond the neck portion 44, such as where the diameter of the shell 26 increases and beyond the area where the neck portion 44 is positioned within the annular flange 40…”.
Regarding claim 11, George et al. teaches wherein the tubular member is operatively coupled to the fluid reservoir. Note figs. 1-3, paragraph [0035]- [0036].
Regarding claim 12, George et al. teaches wherein the extension member forms a closed shape. Note figs. 1-3, paragraph [0035]- [0036]. Note paragraph [0036] specifically teaches the flange or projection member is annular.
Regarding claims 13-14, George et al. teaches wherein the sidewall includes an inner surface and an outer surface, the extension member being coupled to and extending from the inner surface of the sidewall, and wherein in the sidewall includes an inner surface and an outer surface, the inner surface defining the cavity, an extension member being coupled to and extending from the inner surface of the sidewall. Note figs. 1-3, paragraph [0035]- [0036]. Note paragraph [0037] “…In addition, the inside surface 46 of the flange 40 may also be adhered to the portion of the shell 26 beyond the neck portion 44, such as where the diameter of the shell 26 increases and beyond the area where the neck portion 44 is positioned within the annular flange 40…”.
Regarding claim 15, George et al. teaches wherein the fluid reservoir is configured to retain fluid within.
Regarding claim 16, George et al. teaches wherein the tubular member is a first tubular member, the inflatable device further comprising a second tubular member, the second tubular member extending between the pump assembly and the inflatable member. Note figs. 1-3, paragraph [0034]- [0036].
Claim Rejections - 35 USC § 103
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 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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hakky(US20180289489) hereinafter Hakky in view of Trick et al.(FR2600525) hereinafter Trick et al.
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Hakky teaches a penile prosthesis includes a pump. The penile prosthesis includes a reservoir, wherein the reservoir is fluidically connected to the pump. The penile prosthesis includes an inflatable cylinder, wherein the inflatable cylinder is fluidically connected to the pump through a length-adjustable tube. The length-adjustable tube allows adjustment of a length of the length-adjustable tube according to a patient's unique anatomy. [0051] FIGS. 4A and 4B is a schematic drawing of an assembly 400 of a pump 405 and a length-adjustable tube 421 according to one embodiment of the disclosure. FIG. 4A is a schematic drawing of an assembly 400 of a pump 405 and a length-adjustable tube 421 in a reduced-length mode according to one embodiment of the disclosure. FIG. 4B is a schematic drawing of an assembly 400 of pump 405 and length-adjustable tube 421 in an extended-length mode according to one embodiment of the disclosure. [0054] The assembly 400 includes a length-adjustable tube 421 and a nut 415. The nut 415 is removably and/or releasably secured to the valve set 410.
[0055] In one embodiment, the nut 415 has at least two positions. In a first position, the nut 415 is tightly secured to the valve set 410. When the nut is in the first position, the length-adjustable tube 421 is secured in place and cannot be pulled or pushed to make any longitudinal movement and/or length adjustment.
[0056] In another embodiment, the nut 415 can be in a second position. In the second position, the nut 415 is loosened up from the valve set. When the nut 415 is loosened up, the length-adjustable tube 421 can be pulled further out from the pump to extend the length of the tubing. At the same time, when the nut 415 is loosened up, the length-adjustable tube 421 can be pushed back into the pump to reduce the length of the tubing.
Regarding claim 9, Hakky teaches a fluid reservoir defining a cavity;
an inflatable member;
a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member; and
a tubular member extending between the fluid reservoir and the pump assembly, the tubular member having a first end that is disposed within the cavity defined by the fluid reservoir wherein the tubular member is a first tubular member, the inflatable device further comprising a second tubular member, the second tubular member extending between the pump assembly and the inflatable member. Note figs. 1 and 4a-4b and corresponding description. Hakky teaches the desirability of having an adjustable fluid conduit between the reservoir and the pump as well as between the pump and the inflatable members and teaches the excess tubing could be pushed into the pump.
Hakky does not specifically teach the tubular member extends within the cavity defined by the fluid reservoir.
Trick et al. in the same field of endeavor teaches A prosthesis of the infusion erection system includes a distribution device to be implanted in a scrotal bag or subcutaneously in an area adjacent to the scrotal bag. it includes a reservoir 14 for storing product stimulating erection and a pumping arrangement 12 for moving the product stimulating erection from reservoir 14 via a drain tube 78 connected to the cavern body of the penis. the pump30, which causes the movement of the product stimulating the erection, can be actuated manually or electrically. The pump portion 30 also includes a fluid suction portion 50 and having an extension tube 52 which extends into the reservoir 14. The fluid suction portion 50 is formed with a suction channel 54 which is connected to the pump channel 32. The suction channel 54 has a valve seat 56 provided with a ball valve 58. The ball valve 58 closes the extension tube 52 under the action of a spring 60, retained in the suction channel by an annular bulge 62.
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Note extension tube 52 extends into the reservoir 14.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the penile implant of Hakky to allow the adjustable fluid conduit to not only extend into the pump but the fluid reservoir as shown by Trick et al. to allow the fluid to be transferred from the reservoir through the pump and it would improve the adjustability of the fluid conduit of Hakky to have an additional place to store excess tubing when adjusting the device to a specific patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Buuck (US 3954102) teaches The prosthesis comprises a pair of expandable cylinders which are implanted in the penis, replacing the function of the two corpora cavernosa. Supplying fluid to the expandable cylinders is a fluid transfer mechanism that is also implanted in the patient's body so as to permit inflation of the cylinders when an elastomeric bulb is squeezed through the person's skin. In addition to the elastomeric bulb, the fluid transfer system includes a reservoir, a first check valve between the bulb and reservoir, a second check valve between the cylinders and bulb, and a special valve that can be manually operated to by-pass the check valves. Note Fig. 6 appears to show a fluid conduit extending into the reservoir.
Schulte et al.( US 4588394) teaches a totally subcutaneously implantable infusion reservoir and pump system includes a variable capacity reservoir for receiving and storing fluids containing medications for delivery to a catheter which directs the medications to a specific infusion location in the body. A pump and a valving arrangement is interposed between the reservoir and the catheter to facilitate and control the transfer of the medications from the reservoir to the catheter in a safe and efficient manner. Note figure 1, fluid conduit 84 extends into reservoir 12.
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.
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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.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791