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 .
Response to Amendment
Applicant’s Amendment and Remarks filed 08/11/2026 is acknowledged. Claims 10 has been amended. Claims 24 has been added. Claims 1-16 and 21-24 are pending.
Response to Arguments
Applicant's arguments filed 08/11/2026 have been fully considered but they are not persuasive.
Regarding claim 1,
Applicant argues, the proposed combination lacks articulated, claim-directed rationale as to why one would be motivated to combine the teachings of Trick et al. with those of George et al. Further, Trick et al. is different from George et al. in both structure and operation.
The examiner respectfully disagrees. Both George et al. and Trick et al. are directed to aspects of pumping fluid from a reservoir in a penile implant device and both have structural arrangements for the tubing as it connects the reservoir to the pumping mechanism including where the tubing may extend into the reservoir. The degree to which the tubing extends into the reservoir of a penile implant would be a matter of design choice and would be recognized by one of ordinary skill in the art looking at both George et al. or Trick et al. which both have particular structural arrangements for the tubing connecting the pump to the reservoir and for pumping fluid from a reservoir to a penile implant.
Regarding claim 24,
With respect to the added language “configured to help retain air bubbles within the cavity of the fluid reservoir such that the air bubbles are not advanced or moved to the pump assembly or the inflatable member when the pump assembly draws fluid from the fluid reservoir and passes such fluid to the inflatable member.”. It is noted that, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 10,
With respect to the added language “configured to help retain air bubbles within the cavity of the fluid reservoir such that the air bubbles are not advanced or moved to the pump assembly or the inflatable member when the pump assembly draws fluid from the fluid reservoir and passes such fluid to the inflatable member.”. It is noted that, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are: “wherein the extension member is configured to help retain air bubbles within the fluid reservoir” as set forth in claims 10 and 24. The examiner interprets this language to correspond to the structure as set forth in the specification for example paragraph [0047] and as shown in Fig. 4 : [0047] In the illustrated embodiment, the sidewall 212 of the fluid reservoir 210 is coupled to an outer surface 276 of the tubular member 270 at a location L along the tubular member 270. The coupling location L is disposed between the end 272 of the tubular member 270 and the end portion of the tubular member 270 that is operatively coupled to the pump assembly 230. Specifically, the coupling location L is disposed a distance from both the end 272 and the end of the tubular member 270 that is coupled to the pump assembly 230.
This interpretation specifically relates to the structural relationship between the reservoir 210 and the tubular member 270 where the tubular member 270 extends into the reservoir 210 a distance L.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
Claim(s) 1-9 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BUUCK(US 3954102) hereinafter BUUCK.
BUUCK teaches 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. In this way, the degree of erection of the penis is controlled.
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Regarding claim 1-9 and 24, BUUCK 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 such that the fluid reservoir is configured to be disposed within a first portion of a body of a patient and the pump assembly is configured to be disposed within a second portion of the body of the patient different than the first portion of the body, the tubular member having a first end that is disposed within the cavity defined by the fluid reservoir. Note Figures 1-3 show the reservoir located separately and at a distance from the pump and the inflatable members. Note annotated figure 6 above and the corresponding description Col. 4 lines 31-42. “one end 60a of the tube 60 has communication with the interior of the reservoir 55”. Note annotated figure 6 above shows the tube 60a extending a distance into the reservoir.
Regarding claims 2-5, BUUCK teaches wherein the tubular member is operatively coupled to the fluid reservoir. Note Figures 1-3 show the reservoir located separately and at a distance from the pump and the inflatable members. Note annotated figure 6 above and the corresponding description Col. 4 lines 31-42. “one end 60a of the tube 60 has communication with the interior of the reservoir 55. Note annotated figure 6 above shows the tube 60a extending a distance into the reservoir.
Regarding claims 6-8, BUUCK teaches wherein the fluid reservoir is configured to retain fluid within the cavity defined by the fluid reservoir. Note Figures 1-3 show the reservoir located separately and at a distance from the pump and the inflatable members. Note annotated figure 6 above and the corresponding description Col. 4 lines 31-42.
Regarding claim 9, BUUCK 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 Figures 1-3 show the reservoir located separately and at a distance from the pump and the inflatable members. Note annotated figure 6 above and the corresponding description Col. 4 lines 31-42 and elements 112, 122, and 124 transfer fluid from the pump to the inflatable members.
Regarding claim 24, BUUCK teaches Where the “one end 60a of the tube 60 has communication with the interior of the reservoir 55”. Note annotated figure 6 above shows the tube 60a extending a distance into the reservoir. It is the examiner’s interpretation that since the structure is the same the tube extending into the reservoir in the device of BUUCK will also be “configured” for the same intended use as set forth in claim 24 and therefore the device of BUUCK will also “help retain air bubbles within the cavity of the fluid reservoir such that the air bubbles are not advanced or moved to the pump assembly or the inflatable member when the pump assembly draws fluid from the fluid reservoir and passes such fluid to the inflatable member”. It is noted that, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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) 1-16 and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over George et al.(US20050113639) hereinafter George et al. in view of Trick et al.(FR2600525) hereinafter Trick 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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Note also paragraphs [0048] – [0049]: [0048] an adapter 168 is illustrated in FIG. 15 and includes a primary fluid passage 174 that extends generally through the center of the adapter 168. The adapter 168 further includes an annular flange 180 that is spaced from and circumferentially surrounds that passage 174, and an annular tube extension 190 that closely surrounds the passage 174. An additional annular ridge portion 182 may also optionally be included in the structure and positioned between the tube extension 190 and the flange 180. The tube extension 190 is preferably high enough to extend past the end of the annular flange 180, as shown, so that if an attached shell collapses, it will contact the tube extension 190. To promote fluid flow, the tube extension 190 also preferably includes a series of perforations or openings 196 through which fluid can flow for fluid movement between the fluid passage 174 and an attached shell. The perforations or openings 196 are preferably in direct fluid communication with the primary fluid passage 174 and the area immediately surrounding the extension 190, as shown. The perforations 196 may be sized and spaced around the circumference of tube extension 190 in any desired configuration that provides the desired fluid flow without compromising the strength of the tube extension (i.e., the extension 190 should not collapse or otherwise deform significantly). [0049] The tube extension 190 may have either an open end that allows fluid to flow directly to and from the fluid passage 174 when a collapsed shell is not resting on the end of extension 190, or the tube extension 190 may instead have a closed end so that the only fluid communication with the fluid passage 174 is via the perforations 196. Further, when perforations or openings are used along the length of the extension 190, the perforations may have any of a wide variety of shapes and sizes, such as the circular shaped perforations 196 of FIG. 15. The number of perforations for a particular tube extension 190 may also vary, and the shape, locations, and spacing of the perforations may be different, depending on the configuration of the adapter. The tube extension 190 may optionally include a shaped feature at its end (e.g., a sphere, an ellipse, or the like) that will extend into the inner area of an attached reservoir shell. The shaped feature can help to maintain patency and minimize wear or damage to a collapsed shell that is supported on its surface. Whether or not such a feature is used, it is preferable that the surfaces of the tube extension 190 are relatively smooth and free from sharp edges that might damage a shell surface.
Regarding claims 1 and 3-5, 7-8, George et al. 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 such that the fluid reservoir is configured to be disposed within a first portion of a body of a patient and the pump assembly is configured to be disposed within a second portion of the body of the patient different than the first portion of the body. Note annotated figure 1 above. Also as set forth above, the annular flange 40 extends from a sidewall of the reservoir where the reservoir is considered to include shell 26 and connected adapter 34 and extends around an entire circumference of the sidewall. Since the flange may be adhered to the shell 26 of the reservoir as taught in paragraph [0037] this supports the examiner’s interpretation the reservoir may include the adapter and annular flange as all part of the reservoir. Tube 24 connects between the reservoir and the pump and extends into the adapter 34 which is considered part of the reservoir.
Also in view of figure 15 and paragraphs [0048]-[0049] of George et al. , it is the examiner’s interpretation George et al. implies the tube extends beyond the adapter and thus into the integrated reservoir.
George et al. does not explicitly teach the tubular member having a first end that is disposed within the cavity defined by the fluid reservoir.
Trick et al. in the same field of endeavor teaches a prosthetic infusion erection system that 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 George et al. to allow the conduit 24 to extend into the fluid reservoir 26 as shown by Trick et al. to allow the fluid to be efficiently transferred from the reservoir through the pump to the inflatable member(s). ”. It is further noted that there are a limited number of choices available to a person of ordinary skill in the art for successfully pumping fluid from a reservoir for penile implants. Both George et al. and Trick et al. are directed to aspects of pumping fluid from a reservoir in a penile implant device and both have structural arrangements for the tubing as it connects the reservoir to the pumping mechanism including where the tubing may extend into the reservoir. Therefore, it would have been obvious to one of ordinary skill in the art as a matter of design choice to try extending the tubing into the reservoir as implied by George et al. and shown by Trick et al. to successfully pump the fluid from the reservoir with a reasonable expectation of successfully managing the fluid within the penile implant device. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 2, George et al. teaches wherein the tubular member is operatively coupled to the fluid reservoir. Note annotated figure 1 above.
Regarding claim 6, George et al. teaches wherein the fluid reservoir is configured to retain fluid within the cavity defined by the fluid reservoir. [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.
Regarding claim 9, 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 annotated figure 1 above and paragraph [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.
Regarding claim 21, George et al. teaches wherein the first location of the body of the patient is an abdominal area of the patient and the second location of the body of the patient is within a corpus cavernosae of the patient. Note paragraph [0003] One type of penile implant device, commonly known as a three-piece device, includes a pair of inflatable cylindrical prostheses that are implanted into the corpus cavenosae of the penis, which are connected to a fluid-filled reservoir through a pump and valve assembly. Such a pump and valve assembly is typically implanted into the scrotum of the patient, and the reservoir is implanted in the abdomen.
Regarding claim 24, George et al. in view of Trick et al. includes the same structure wherein the first end of the tubular member includes an outer surface that is therefore “configured” to help retain air bubbles within the cavity of the fluid reservoir such that the air bubbles are not advanced or moved to the pump assembly or the inflatable member when the pump assembly draws fluid from the fluid reservoir and passes such fluid to the inflatable member. It is the examiner’s interpretation that since the structure is the same, the tube extending into the reservoir in the device of George et al. in view of Trick et al. will also be “configured” for the same intended use as set forth in claim 24 and therefore the device of George et al. in view of Trick et al. will also “help retain air bubbles within the cavity of the fluid reservoir such that the air bubbles are not advanced or moved to the pump assembly or the inflatable member when the pump assembly draws fluid from the fluid reservoir and passes such fluid to the inflatable member”. It is noted that, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 10, George et al. teaches a fluid reservoir having a sidewall defining a cavity and an extension member extending from an inner surface of the sidewall into the cavity defined by the fluid reservoir, the extension member extending around an entire circumference of the inner surface of the sidewall; 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 annular flange 40 extends from a sidewall of the reservoir where the reservoir is considered to include shell 26 and connected adapter 34 and extends around an entire circumference of the sidewall. Since the flange may be adhered to the shell 26 of the reservoir as taught in paragraph [0037] this supports the examiner’s interpretation the reservoir may include the adapter and annular flange as all part of the reservoir. 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…”. 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.
Also in view of figure 15 and paragraphs [0048]-[0049] of George et al. , it is the examiner’s interpretation George et al. implies the tube extends beyond the adapter and thus into the integrated reservoir.
George et al. does not explicitly teach the tubular member having a first end that is disposed 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.
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 George et al. to allow the conduit 24 to extend into the fluid reservoir 26 as shown by Trick et al. to allow the fluid to be efficiently transferred from the reservoir through the pump to the inflatable member(s). ”. Regarding the intended use set forth in claim 10, “wherein the extension member is configured to help retain air bubbles within the fluid reservoir”. It is noted that, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. ”. It is further noted that there are a limited number of choices available to a person of ordinary skill in the art for successfully pumping fluid from a reservoir for penile implants. Both George et al. and Trick et al. are directed to aspects of pumping fluid from a reservoir in a penile implant device and both have structural arrangements for the tubing as it connects the reservoir to the pumping mechanism including where the tubing may extend into the reservoir. Therefore, it would have been obvious to one of ordinary skill in the art as a matter of design choice to try extending the tubing into the reservoir as implied by George et al. and shown by Trick et al. to successfully pump the fluid from the reservoir with a reasonable expectation of successfully managing the fluid within the penile implant device. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
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].
Regarding claim 22, George et al. teaches wherein the projection is formed monolithically with the sidewall. Note paragraph [0041] With any of the shapes chosen for the shell, an associated adapter should be designed to accommodate attachment of a portion of the shell to the adapter or molding of the shell adapter into one integral structure.
Regarding claim 23, George et al. teaches wherein the extension member extends around the entire circumference of the inner surface of the sidewall such that the extension member forms a circular or an oval shape. Note paragraph [0040], the adapter and an annular flange have a cylindrical shape which would have a circular cross section. [0040] Again referring to FIGS. 4 and 5, the adapter 34 preferably includes a support structure 47 that comprises a plurality of elements 48. The elements 48 are positioned within an interior space 50 of the body portion 38. In one preferred embodiment, the elements 48 are arranged circumferentially around the opening 27 to the fluid passage 36. The elements 48 preferably have a generally cylindrical shape as they extend away from the opening 27; however, the elements 48 may be any of a wide number of regular or irregular shaped structures. Each of the plurality of elements 48 within a particular adapter 34 may be shaped and sized to be identical to one another, or may instead have a different size, shape, and/or height from other adjacent elements 48.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Abdelmalek(US 20090209808) teaches an implantable system for erectile dysfunction treatment includes an implantable pump having an inlet and an outlet port. The inlet port is configured to receive blood from an artery within the body. The outlet port is configured to receive the blood from the inlet port and deliver that blood to an artery having a direct or indirect path to the corpora cavernosa of the penis. Activation of the pump, preferably via manual compression or electrical activation, causes the transfer of blood and ultimately an erection. Upon conclusion of sexual activity, blood drains from the penis in a normal manner and returns the penis to a flaccid state. The pump preferably incorporates a non-return valve to prevent backflow of blood from outlet port to inlet port.
Sultan(US 6679832) teaches implantable system for treating male impotence by delivering a vasodilator agent directly to the erectile bodies of the penis comprising an implantable supply pump; deformable reservoir; conducting catheter; and a dispensing catheter. The supply pump is implanted into the abdominal wall. It includes a fluid chamber for holding a vasodilator substance and pressure chamber for exerting a pressure on a plate positioned between the two chambers for delivering the substance into a conducting catheter. The pressure chamber is either spring driven or driven by a liquid-vapor pressure reservoir. The deformable reservoir is preferably implanted in the scrotum and being manually deformable for forcing the substance therefrom and into a dispensing catheter to the erectile bodies of the penis. The dispensing catheter tip is preferably expandable and is operable to expand when the substance is forced into the catheter. The catheter tip includes plurality of openings for dispensing the substance therefrom into the erectile bodies.
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.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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