DETAILED ACTION
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
The Office Action is responsive to the Amendment filed 29 June 2026. Claims 1,2, 11, 13, 16, 17, and 21-24 are now pending. The Examiner acknowledges the amendments to Claims 1, 2, 11, 13, 16, 17, and claims 21-24.
Claim Objections
Claim 13, objected to because of the following informalities:
Regarding claim 13, in line 5, “thea form member” should be rewritten as “the form member”.
Appropriate correction is required.
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.
Claims 1, 2, 11, 13, 16, 17, and 21-24 are rejected under 35 U.S.C. 103 as being obvious over DiLoreto (US 20180042724 A1) in view of Porter et al. (US 20050137614 A1).
Regarding claim 1, DiLoreto teaches an implant (penile prosthesis 200, shown in annotated Fig. 3 below) comprising:
An inflatable member (inflation chamber 222, shown in annotated Fig. 3 below)
A pump assembly (pump assembly 201, shown in annotated Fig. 3 below), the pump assembly being configured to facilitate a transfer of fluid to and from the inflatable member (“user may actuate the pump bulb of the pump assembly to further transfer the fluid from the reservoir to the inflatable member”, paragraph [0028]; pump assembly 201, shown in annotated Fig. 3 below), the pump assembly includes a housing member (housing 462 in Fig. 4D)
A tubular member extending between the inflatable member and the pump assembly (conduit connectors 205 between inflatable member and pump assembly shown in annotated Fig. 3 below)
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DiLoreto does not teach a coupler configured to couple the tubular member to the housing member, and a form member defining a lumen.
However, Porter et al. teaches a coupler configured to couple the tubular member to the housing member (“connector comprises…a first end…to receive a first body fluid conduit, a second end adapted to receive a second body fluid conduit”, paragraph [0006]; connector 2, shown in annotated Fig. 1A); and
A form member defining a lumen (“connector sleeve 44 comprises silicone”, paragraph [0047]; connector sleeve 44, also shown in annotated Fig. 2A below), the tubular member extending through the lumen defined by the form member, the form member being disposed within the housing member (the form member would be disposed within the housing member to connect the housing member to the tubular member).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the implant of DiLoreto with the coupler of Porter et al. in order to facilitate a coupling of the tubular member to the pump assembly in order to ensure a secure connection between parts and allow for the inflation of the inflatable members.
Regarding claim 2, DiLoreto in view of Porter et al. teaches all the limitations of claim 1.
Furthermore, Porter et al. teaches a coupler (connector 2, shown in annotated Fig. 1A below), including a first portion disposed within a lumen defined by the tubular member (second end 8, lumen 10, shown in annotated Fig. 1A below) and a second portion disposed within another tubular member (first end 4, shown in annotated Fig. 1A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the implant of DiLoreto in view of Porter et al. and have the second portion of the coupling member be disposed within the housing of the pump assembly (shown in annotated Fig. 4D of DiLoreto below), in order to facilitate a fluid connection between the tubular member and the pump assembly, and allow for the pump assembly to inflate the inflatable members.
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Regarding claim 11, DiLoreto in view of Porter et al. teaches all the limitations of claim 1.
Furthermore, Porter et al. teaches the coupler including a first portion disposed within a lumen defined by the tubular member, the form member (“connector sleeve 44 comprises silicone”, paragraph [0047]; connector sleeve 44, also shown in annotated Fig. 2A below) disposed such that a portion of the tubular member is disposed between the form member and the coupler (“connector sleeve 44 is radially expanded as it is placed over the connector 2 and joined conduits 12 and 14”, paragraph [0047]; shown in annotated Fig. 2A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the coupling member of DiLoreto in view of Porter et al. and implement a silicone form member to help with the connection of the tubular members to the housing of the pump assembly.
Regarding claim 13, DiLoreto in view of Porter et al. teaches all the limitations of claim 1, and wherein the tubular member is a first tubular member and the lumen defined by the form member is a first lumen (conduit connectors 205, Fig. 3).
Porter et al. teaches the form member defining a first lumen, but does not teach it defining a second lumen.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the form member to define a second lumen for the second tubular member to inflate its respective inflatable member, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 16, DiLoreto teaches an implant (penile prosthesis 200, shown in annotated Fig. 3 below) comprising:
An inflatable member (inflation chamber 222, shown in annotated Fig. 3 below)
A pump assembly (pump assembly 201, shown in annotated Fig. 3 below), the pump assembly being configured to facilitate a transfer of fluid to and from the inflatable member (“user may actuate the pump bulb of the pump assembly to further transfer the fluid from the reservoir to the inflatable member”, paragraph [0028]; pump assembly 201, shown in annotated Fig. 3 below), the pump assembly including a housing (housing 462 in Fig. 4D)
A first and second tubular member extending between the inflatable member and the pump assembly (conduit connectors 205 between inflatable member and pump assembly shown in annotated Fig. 3 below), at least a portion of the first tubular member extending into the housing (conduit connectors 205 are placed within the housing in Fig. 4D)
DiLoreto does not teach a first and second coupling member, and a form member being disposed within the housing member.
Porter et al. teaches a coupler for connecting implanted conduits (“connector comprises…a first end…to receive a first body fluid conduit, a second end adapted to receive a second body fluid conduit”, paragraph [0006]; connector 2, shown in annotated Fig. 1A), the coupling member able to be configured to facilitate a coupling of the tubular member to the pump assembly (shown in annotated Fig. 1A below); and
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A form member disposed within the housing and coupled to the first tubular member (connector sleeve 44 comprises silicone”, paragraph [0047]; connector sleeve 44, also shown in annotated Fig. 2A), such that a portion of the tubular member is disposed between the form member and a portion of the coupling member (“connector sleeve 44 is radially expanded as it is placed over the connector 2 and joined conduits 12 and 14”, paragraph [0047]; shown in annotated Fig. 2A).
Furthermore, Porter et al. fails to teach a second coupling member and the form member being coupled to the second tubular member.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a second tubular member to ensure flow from the pump assembly to its respective inflatable member, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 17, DiLoreto in view of Porter et al. teaches all the limitations of claim 16.
Furthermore, Porter et al. teaches the first coupler (connector 2, shown in annotated Fig. 1A below), including a first portion disposed within a lumen defined by the tubular member (second end 8, lumen 10, shown in annotated Fig. 1A below)
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the implant of DiLoreto in view of Porter et al. and have the first be disposed within the lumen defined by the first tubular member (shown in annotated Fig. 4D of DiLoreto below), in order to facilitate a fluid connection between the tubular member and the pump assembly, and allow for the pump assembly to inflate the inflatable members.
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Regarding claims 21 and 22, DiLoreto in view of Porter et al. teaches all the limitations of claim 16, but does not teach the form member defining a first lumen and a second lumen and a first tubular member extending through the first lumen of the form member, and the second tubular member extending through the second lumen of the form member.
Porter et al. teaches the form member defining a first lumen for a first tubular member to extend through, but does not teach it defining a second lumen for a second tubular member.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the form member to define a second lumen for the second tubular member to inflate its respective inflatable member, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 23, DiLoreto in view of Porter et al. teaches all the limitations of claim 16.
Furthermore, Porter et al. teaches a portion of the tubular member being disposed between the form member and the coupler (“connector sleeve 44 is radially expanded as it is placed over the connector 2 and joined conduits 12 and 14”, paragraph [0047]; shown in annotated Fig. 2A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the coupling member of DiLoreto in view of Porter et al. and have the tubular member be in between the form member and coupling member to help with the connection of the tubular members to the housing of the pump assembly.
Regarding claim 24, DiLoreto in view of Porter et al. teaches all the limitations of claim 16, as well as a portion of the first tubular member being disposed between the first coupler and the form member, but does not teach a portion of the second tubular member being disposed between the second coupler and the form member.
Porter et al. teaches a first tubular member being disposed between the first coupler and the form member.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the second tubular member being disposed between the second coupler and the form member the same way as the first member as taught by Porter et al., since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Response to Arguments
Applicant’s arguments, see page 5, filed 29 June 2026, with respect to the drawing objections have been fully considered and are persuasive in light of the amendments. The objections have been withdrawn.
Applicant’s arguments, see page 5, filed 29 June 2026, with respect to the claim objections have been fully considered and are persuasive in light of the amendments. The objections have been withdrawn.
Applicant’s arguments with respect to claims 1, 2, 11, 13, 16, 17, and 21-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection of all pending claims 1, 2, 11, 13, 16, 17, and 21-24 under 35 U.S.C. § 103 have been updated accordingly.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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