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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Note page 9, paragraph 45, elements 244, 246, 248, 250, W5, W8, and W9 are not shown. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 20 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 20 depends from claim 19 and sets forth “wherein the pump assembly includes a cavity having a first portion, a second portion, and a transition portion being disposed between the first portion and the second portion, the first portion having a first width” which were previously set forth in claim 19. It is unclear if applicant intends to attempt to introduce an additional cavity with a first portion and second portion having widths or refer to those introduced in claim 19. The examiner will interpret claim 20 as if it were to depend from claim 16.
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 –
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trick(5101813) hereinafter Trick.
Trick teaches a multi-component, penile erectile system which is to be surgically implanted in man for the treatment of erectile impotence includes at least one elongated, flexible cylindrical member with a pressure chamber for implanting into the pendulous penis; a pressure bulb to be implanted in the scrotal sac; tubing integrally connecting the pressure chamber and the bulb to form a closed system. (19) The present invention basically comprises a sterile, completely assembled penile erectile system consisting of at least one elongated, flexible, cylindrical member which is to be implanted in the pendulous penis, a pressure bulb which is to be implanted in the scrotum and integral tubing which connects the bulb to a pressure chamber in the cylindrical member to form a closed system. The pressure bulb is either a single stroke bulb which sucks fluid from the pressure chamber or a unique multi-stroke pump which is capable of higher pressure with less actuating force than a single stroke bulb.
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Regarding claims 1 and 16, Trick teaches an inflatable member; and
a pump assembly having a cavity, a valve, and a valve housing, the pump assembly being configured to facilitate a transfer of a fluid from the cavity to the inflatable member, the valve housing being configured to be deformed to allow the fluid to move from the inflatable member to the cavity. Note figure 1, and annotated Figs 12-13 and corresponding description, Col. 6, lines 1-37. When force is extended on the pump assembly, as shown in FIG. 13, pressurizing fluid 41 in the reservoir 45 is forced through the inlet check valve 47 and outlet check valve 48 of the pumping chamber 46 and through the passageways 49, 50 and 51 to the supply tubing 13, 13' to the pressure chambers. When it is desired to depressurize the pressure chambers, force is exerted on the housing 52 to distort the seat 53 for the ball 54 and to allow pressurized fluid 41 to flow over the ball 54 into the reservoir 45. When the distorting force is released on the housing 52 the spring 55 will direct the ball 54 back into sealing engagement with the seat 53 and the passage 56 will be closed.
Regarding claims 2 and 19, Trick teaches wherein the cavity includes a first portion, a second portion, and a transition portion being disposed between the first portion and the second portion. Note figure 1, and annotated Figs 12-13 and corresponding description, Col. 6, lines 1-37. It is the examiner’s interpretation, the cavity includes a first upper portion and second lower portion and a transition portion in between.
Regarding claim 3, Trick teaches wherein the cavity includes a first portion, a second portion, and a transition portion being disposed between the first portion and the second portion, the first portion having a first width, the transition portion having a second width, the second width being smaller than the first width. Note figure 1, and annotated Figs 12-13 and corresponding description, Col. 6, lines 1-37. It is the examiner’s interpretation, the cavity includes a first upper portion and second lower portion and a transition portion in between. The “width” of the transition portion is smaller than that of the first portion and the second portion.
Regarding claim 4, Trick teaches wherein the cavity includes a first portion, a second portion, and a transition portion being disposed between the first portion and the second portion, the first portion having a first width, the second portion having a second width, the transition portion having a third width, the third width begin smaller than the first width, the third width being smaller than the second width. Note figure 1, and annotated Figs 12-13 and corresponding description, Col. 6, lines 1-37. It is the examiner’s interpretation, the cavity includes a first upper portion and second lower portion and a transition portion in between. The “width” of the transition portion is smaller than that of the first portion and the second portion.
Regarding claim 5, Trick teaches wherein the cavity includes a first portion, a second portion, and a transition portion being disposed between the first portion and the second portion, the first portion having a first height, the transition portion having a second height, the second height being smaller than the first height. Note figure 1, and annotated Figs 12-13 and corresponding description, Col. 6, lines 1-37. It is the examiner’s interpretation, the cavity includes a first upper portion and second lower portion and a transition portion in between. The “height” of the transition portion is smaller than that of the first portion and the second portion. Claim 5 depends directly from claim 1 and since there is no distinction between “height” or “width” set forth in claim 1. Fig. 12 as annotated could be a “width” or a “height” of the cavity portions.
Regarding claim 6, Trick teaches wherein the cavity includes a first portion, a second portion, and a transition portion being disposed between the first portion and the second portion, the first portion having a first height, the second portion having a second height, the transition portion having a third height, the third height being smaller than the first height, the third height being smaller than the second height. Note figure 1, and annotated Figs 12-13 and corresponding description, Col. 6, lines 1-37. It is the examiner’s interpretation, the cavity includes a first upper portion and second lower portion and a transition portion in between. The “height” of the transition portion is smaller than that of the first portion and the second portion. Claim 5 depends directly from claim 1 and since there is no distinction between “height” or “width” set forth in claim 1. Fig. 12 as annotated could be a “width” or a “height” of the cavity portions.
Regarding claims 7 and 20, Trick teaches wherein the cavity includes a first portion, a second portion, and a transition portion being disposed between the first portion and the second portion, the first portion having a first width and a first height, the transition portion having a second width and a second height, the second height being smaller than the first height, the second width being smaller than the first width. Note figure 1, and annotated Figs 12-13 and corresponding description, Col. 6, lines 1-37. It is the examiner’s interpretation, the cavity includes a first upper portion and second lower portion and a transition portion in between. It is the examiner’s interpretation since there are no specifics or relationships set forth in the claims, that the “height” of the first portion could extend from the boundary between housing 52 to below the transition portion and would be greater than the “height” of the inside of the transition portion as shown in the annotated figure 12.
Regarding claim 8, Trick teaches wherein the valve includes a first portion, a second portion, and a middle portion being disposed between the first portion and the second portion. Note figure 1, and annotated Figs 12-13 and corresponding description, Col. 6, lines 1-37. Note in the annotated figure 12, the first portion of the valve includes the ball valve 54, the second portion includes the conduit connecting to conduit 13, and the middle portion is the conduit in between the two and the “width” of the middle portion is less than the “width” of the first and second portion.
Regarding claim 9, Trick teaches wherein the valve includes a first portion, a second portion, and a middle portion being disposed between the first portion and the second portion, the first portion having a first width, the second portion having a second width, the middle portion having a third width, the third width being smaller than the first width, the third width being smaller than the second width. Note in the annotated figure 12, the first portion of the valve includes the ball valve 54, the second portion includes the conduit connecting to conduit 13, and the middle portion is the conduit in between the two and the “width” of the middle portion is less than the “width” of the first and second portion.
Regarding claim 10, Trick teaches wherein the valve includes a first portion, a second portion, and a middle portion being disposed between the first portion and the second portion, the first portion having a first width, the second portion having a second width, the middle portion having a third width, the third width being smaller than the first width, the third width being smaller than the second width, the first portion having a seat surface and being configured to engage a portion of the valve housing to form a seal. Note in the annotated figure 12, the first portion of the valve includes the ball valve 54, the second portion includes the conduit connecting to conduit 13, and the middle portion is the conduit in between the two and the “width” of the middle portion is less than the “width” of the first and second portion. Note bias spring 55, seat surface 56 seats valve 54.
Regarding claim 11, Trick teaches wherein the valve includes a first portion, a second portion, and a middle portion being disposed between the first portion and the second portion, the first portion having a first width, the second portion having a second width, the middle portion having a third width, the third width being smaller than the first width, the third width being smaller than the second width, the first portion having a seat surface and being configured to engage a seat portion of the valve housing to form a seal, the pump assembly including a bias member configured to bias the seat surface towards the seat portion of the valve housing to form a seal. Note in the annotated figure 12, the first portion of the valve includes the ball valve 54, the second portion includes the conduit connecting to conduit 13, and the middle portion is the conduit in between the two and the “width” of the middle portion is less than the “width” of the first and second portion. Note bias spring 55, seat surface 56 seats valve 54.
Regarding claim 12, Trick teaches wherein the valve includes a first portion, a second portion, and a middle portion being disposed between the first portion and the second portion, the first portion having a first width, the second portion having a second width, the middle portion having a third width, the third width being smaller than the first width, the third width being smaller than the second width, the first portion having a seat surface and being configured to engage a seat portion of the valve housing to form a seal, the pump assembly including a bias member configured to bias the seat surface towards the seat portion of the valve housing to form a seal, the seat surface being configured to be moved from the seat portion of the valve housing when the valve housing is deformed. Note in the annotated figure 12, the first portion of the valve includes the ball valve 54, the second portion includes the conduit connecting to conduit 13, and the middle portion is the conduit in between the two and the “width” of the middle portion is less than the “width” of the first and second portion. Note bias spring 55, seat surface 56 seats valve 54. When it is desired to depressurize the pressure chambers, force is exerted on the housing 52 to distort the seat 53 for the ball 54 and to allow pressurized fluid 41 to flow over the ball 54 into the reservoir 45. When the distorting force is released on the housing 52 the spring 55 will direct the ball 54 back into sealing engagement with the seat 53 and the passage 56 will be closed.
Regarding claims 13 and 14, Trick teaches wherein the valve housing is configured to be deformed when the valve housing is compressed. When it is desired to depressurize the pressure chambers, force is exerted on the housing 52 to distort the seat 53 for the ball 54 and to allow pressurized fluid 41 to flow over the ball 54 into the reservoir 45. When the distorting force is released on the housing 52 the spring 55 will direct the ball 54 back into sealing engagement with the seat 53 and the passage 56 will be closed.
Regarding claim 15, Trick teaches wherein the valve housing defines a compartment, the valve being disposed within the compartment, the compartment having a first portion, a second portion, and a third portion disposed between the first portion and the second portion, the first portion having a first width, the second portion having a second width, the third portion having a third width, the third width being smaller than the first width, the third width being smaller than the second width. Note in the annotated figure 12, the first portion of the valve housing/compartment includes a conduit with the ball valve 54, the second portion includes the conduit connecting to conduit 13, and the middle portion is the conduit connecting the two and the “width” of the middle portion is less than the “width” of the first and second portion.
Regarding claims 17 and 18, Trick teaches wherein the inflating includes squeezing the pump assembly of the bodily implant a single time and wherein the inflating includes squeezing the pump assembly once and only once. The pressure bulb is either a single stroke bulb which sucks fluid from the pressure chamber or a unique multi-stroke pump which is capable of higher pressure with less actuating force than a single stroke bulb. Col. 2 lines 65 to col. 3, lines 1-2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
VIGNOLI et al.( EP 0119173) teaches The rigid-inflatable means for artificially erecting the penis in incurable cases of impotence comprise a tank-pump 6 that allows the filling with liquid of the cavities made in the two parts 3 of two cylinders 1 and 2 implanted in the corpora cavernosa 12. The said liquid passes from the tank-pump 6 into the said parts 3 of the cylinders 1 and 2 causing them to become rigid and thus giving the penis adequate consistence for vaginal penetration.
Zinner et al.( US 5069201) teaches penile prosthesis includes proximal and distal end portions with an intermediate normally flexible, nondistensible, collapsible main body portion that adjoins the proximal and distal portions. The prosthesis includes a manually manipulable pumping arrangement to establish the necessary fluid movement for development of an erectile condition or a flaccid condition as desired.
Hauschild et al.( US 4895139) teaches n implantable penile prosthesis comprises a tubular body for implantation in a patient's penis and a fluid reservoir for implantation in a patient's body outside the penis. The tubular body and reservoir are in fluid communication with each other. The tubular body comprises a tubular chamber which is inflatable from a flaccid to an erect state when filled substantially to capacity. Fluid flow to and from the chamber is by way of a manually actuatable valve system. The valve system moves between an open position allowing for change from the erect state to the flaccid state, and a closed position allowing for change from the flaccid state to the erect state. The valve system is movable from the second closed position to the first open position by bending of the penis.
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