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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9 January 2026 has been entered.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 6-8, 10, 13, 14, 16-18, 21, and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2007/0142700 (Fogarty et al.).
Regarding claim 1, Fogarty teaches an inflatable penile prosthesis ([0002]-[0003]; [0078]) comprising: a fluid reservoir (1) configured to hold fluid; an inflatable member (5a, b); and a pump assembly (3) configured to transfer the fluid between the fluid reservoir and the inflatable member, the pump assembly including: a pump bulb (8); a valve body having one or more valves (4, 11, 12); and an outer protective casing (14, 15) disposed over the valve body, the outer protective casing having a first side portion, a second side portion opposite the first side portion, and a third side portion, a longitudinal axis of the pump bulb extending between the first side portion and the second side portion (longitudinal axis of the pump bulb extends “between” or from “one to another”, with respect to the first and second side portions as shown in the annotated Figure 4a below), the first side portion having a concave surface, the second side portion having a concave surface, the third side portion defining an opening ([0078]-[0081]; [0109]; Figures 1 and 13a; see annotated Figure 4a below).
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Regarding claim 2, Fogarty teaches the concave surface of the first side portion of the outer protective casing (14, 15) is configured to assist a user to locate a deflation mode actuator (13) of the inflatable penile prosthesis (see Figure 13; [0081]; [0109]).
Regarding claims 6 and 7, Fogarty teaches the opening defined by the third side portion of the outer protective casing being a first opening, wherein the pump assembly (3) includes a plurality of fluid ports (ports connecting to tubing 6, 7a, 7b, [0078] and [0081]; Figure 3), and a deflation mode actuator (13), the outer protective casing (14, 15) including a first end portion defining a second opening, and a second end portion defining a third opening, the pump bulb extending through the second opening, the plurality of fluid ports extending through the third opening, the deflation mode actuator extending through the first opening (see Figure 13a and annotated Figure 4a above; [0109]); wherein the first side portion of the outer protective casing (14, 15) includes a protruded portion having a three-dimensional shape, the protruded portion having a surface the defines at least one ridge (see Figure 13a and annotated Figure 4a above).
Regarding claim 8, Fogarty teaches the outer protective casing (14, 15) includes a polymer material (polysulfone, [0109]).
Regarding claim 10, Fogarty teaches an inflatable penile prosthesis ([0002]-[0003]; [0078]) comprising: a fluid reservoir (1) configured to hold fluid; an inflatable member (5a, b); and a pump assembly (3) configured to transfer the fluid between the fluid reservoir and the inflatable member, the pump assembly including: a pump bulb (8); a deflation mode actuator (13); a valve body having one or more valves (4, 11, 12); and an outer protective casing (14, 15) disposed over the valve body, the outer protective casing having a first tactile feature configured to assist a user to locate the deflation mode actuator and a second tactile feature disposed opposite the first tactile feature, the first tactile feature including a curved surface, the second tactile feature including a curved surface, the first tactile feature being disposed on a first side of a longitudinal axis of the pump bulb, the second tactile feature being disposed on a second side of the longitudinal axis of the pump bulb ([0078]-[0081]; [0109]; “casing” 14, 15 includes ridges and depressions capable of assisting a user to locate the “actuator” 13, including a “first tactile feature” including a curved surface and a “second tactile feature” including a curved surface, given their texture as shown in Figures 1, 4a, and 13a. The “first tactile feature” is construed as a curved surface of casing 14, 15 disposed proximate the “15” marking in Figure 4a, and the ”second tactile feature” is construed as a curved surface of casing 14, 15 proximate the “Fig. 4a” marking as shown in Figure 4a. Accordingly, both tactile features are on opposing sides of the pump bulb longitudinal axis.).
Regarding claim 13, Fogarty teaches the pump assembly (3) includes a plurality of fluid ports (ports connecting to tubing 6, 7a, 7b, [0078] and [0081]; Figure 3), the outer protective casing (14, 15) including a first end portion defining a first opening, and a second end portion defining a second opening, the outer protective casing defining a third opening, the pump bulb extending through the first opening, the plurality of fluid ports extending through the second opening, the deflation mode actuator extending through the third opening (see Figure 13a; [0109]).
Regarding claim 14, Fogarty teaches the outer protective casing (14, 15) includes: a first protruded side portion; and a second protruded side portion, at least one of the first protruded side portion and the second protruded side portion defining at least one ridge (see Figure 13a; [0109]).
Regarding claim 16, Fogarty teaches the outer protective casing (14, 15) includes a material that is different than the valve body (spring 303, which is considered a portion of the “valve body” is made of silicon, [0087], while the “casing” 14, 15 is made of polysulfone, stainless steel, or MP35N, [0109]).
Regarding claim 17, Fogarty teaches a pump assembly (3) for an inflatable penile prosthesis comprising: a valve body having one or more valves (4, 11, 12); a deflation mode actuator (13) movably coupled to the valve body; a pump bulb (8) coupled to the valve body; one or more fluid ports (ports connecting to tubing 6, 7a, 7b, [0078] and [0081]; Figure 3) coupled to the valve body; and an outer protective casing (14, 15) disposed over the valve body, the outer protective casing having a first tactile feature configured to assist a user to locate the deflation mode actuator and a second tactile feature disposed opposite the first tactile feature, the first tactile feature including a curved surface, the second tactile feature including a curved surface, the first tactile feature being disposed on a first side of a longitudinal axis of the pump bulb, the second tactile feature being disposed on a second side of the longitudinal axis of the pump bulb (“casing” 14, 15 includes ridges and depressions capable of assisting a user to locate the “actuator” 13, including a “first tactile feature” including a curved surface and a “second tactile feature” including a curved surface, given their texture as shown in Figures 1, 4a, and 13a; [0109]. The “first tactile feature” is construed as a curved surface of casing 14, 15 disposed proximate the “15” marking in Figure 4a, and the ”second tactile feature” is construed as a curved surface of casing 14, 15 proximate the “Fig. 4a” marking as shown in Figure 4a. Accordingly, both tactile features are on opposing sides of the pump bulb longitudinal axis.).
Regarding claim 18, Fogarty teaches the outer protective casing (14, 15) includes a first end portion defining a first opening, a second end portion defining a second opening, and a side portion defining a third opening, the pump bulb (8) extending through the first opening, the one or more fluid ports (6, 7a, 7b) extending through the third opening, the deflation mode actuator (13) extending through the third opening (see Figures 4a and 13a; [0109]).
Regarding claim 21, Fogarty teaches the outer protective casing (14, 15) includes a material that is different than the valve body (spring 303, which is considered a portion of the “valve body” is made of silicon, [0087], while the “casing” 14, 15 is made of polysulfone, stainless steel, or MP35N, [0109]).
Regarding claims 22-24, Fogarty teaches the outer protective casing (14, 15) is formed separately from the valve body (girdle component 14 formed in two halves and placed to intimately contact pump 3, complimentary snap ring 15 secures girdle component, [0109]; Figures 4a and 13a).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2007/0142700 (Fogarty et al.) in view of U.S. Patent No. 5,344,388 (Maxwell et al.).
Regarding claim 9, Fogarty teaches all the limitations of claim 1. Fogarty does not teach the outer protective casing includes a silicone material.
However, Maxwell teaches an inflatable penile prosthesis (abstract), comprising a pump bulb (26) including an outer protective casing including silicone material (col. 3, lines 46-50 and lines 57-65; Figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the outer protective casing of Fogarty to include a silicone material as taught by Maxwell, as silicone is “a nontoxic, nonreactive material…having surface morphology with good tissue adherence and tissue ingrowth characteristics” (Maxwell: col. 3, lines 59-65).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 6-10, 13, 14, 16-18, 21, and 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,337,814 in view of U.S. Patent Application Publication No. 2007/0142700 (Fogarty et al.).
Regarding instant claim 1, claim 1 of the ‘814 patent recites all the limitations of instant claim 1, except the limitations “a pump bulb” and “a longitudinal axis of the pump bulb extending between the first side portion and the second side portion, the first side portion having a concave surface, the second side portion having a concave surface, the third side portion defining an opening”.
However, Fogarty teaches an inflatable penile prosthesis ([0002]-[0003]; [0078]) comprising: a fluid reservoir (1) configured to hold fluid; an inflatable member (5a, b); and a pump assembly (3) configured to transfer the fluid between the fluid reservoir and the inflatable member, the pump assembly including: a pump bulb (8); a valve body having one or more valves (4, 11, 12); and an outer protective casing (14, 15) disposed over the valve body, the outer protective casing having a first side portion, a second side portion opposite the first side portion, and a third side portion, a longitudinal axis of the pump bulb extending between the first side portion and the second side portion (longitudinal axis of the pump bulb extends “between” or from “one to another”, with respect to the first and second side portions as shown in the annotated Figure 4a below), the first side portion having a concave surface, the second side portion having a concave surface, the third side portion defining an opening ([0078]-[0081]; [0109]; Figures 1 and 13a; see annotated Figure 4a above). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prosthesis of claim 1 of the ‘814 patent to include a pump bulb as taught by Fogarty in order to facilitate selective hydraulic actuation of the prosthesis ([0081]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to modify the outer protective casing of claim 1 of the ‘814 patent such that the first side portion having a concave surface, the second side portion having a concave surface, the third side portion defining an opening and a longitudinal axis of the pump bulb extending between the first side portion and the second side portion as taught by Fogarty in order to enable a user to navigate the valve body and its operation via tactile landmarks during use.
Regarding instant claims 2 and 6-9, claims 1, 2, and 6-9 of the ‘814 patent as modified recites all the limitations of instant claims 2 and 6-9.
Regarding instant claim 10, claim 10 of the ‘814 patent recites all the limitations of instant claim 10, except the limitation “a second tactile feature disposed opposite to the first tactile feature, the first tactile feature including a curved surface, the second tactile feature including a curved surface, the first tactile feature being disposed on a first side of a longitudinal axis of the pump bulb, the second tactile feature being disposed on a second side of the longitudinal axis of the pump bulb”.
However, Fogarty teaches an inflatable penile prosthesis ([0002]-[0003]; [0078]) comprising: a fluid reservoir (1) configured to hold fluid; an inflatable member (5a, b); and a pump assembly (3) configured to transfer the fluid between the fluid reservoir and the inflatable member, the pump assembly including: a deflation mode actuator (13); a valve body having one or more valves (4, 11, 12); and an outer protective casing (14, 15) disposed over the valve body, the outer protective casing having a first tactile feature configured to assist a user to locate the deflation mode actuator and a second tactile feature disposed opposite the first tactile feature, the first tactile feature including a curved surface, the second tactile feature including a curved surface, the first tactile feature being disposed on a first side of a longitudinal axis of the pump bulb, the second tactile feature being disposed on a second side of the longitudinal axis of the pump bulb ([0078]-[0081]; [0109]; “casing” 14, 15 includes ridges and depressions capable of assisting a user to locate the “actuator” 13, including a “first tactile feature” including a curved surface and a “second tactile feature” including a curved surface, given their texture as shown in Figures 1, 4a, and 13a. The “first tactile feature” is construed as a curved surface of casing 14, 15 disposed proximate the “15” marking in Figure 4a, and the ”second tactile feature” is construed as a curved surface of casing 14, 15 proximate the “Fig. 4a” marking as shown in Figure 4a. Accordingly, both tactile features are on opposing sides of the pump bulb longitudinal axis.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prosthesis of claim 10 of the ‘814 patent, as modified, such that the first and second tactile surfaces each include a curved surface and the first tactile feature being disposed on a first side of a longitudinal axis of the pump bulb, the second tactile feature being disposed on a second side of the longitudinal axis of the pump bulb as taught by Fogarty, in order to enable a user to navigate the valve body and its operation via tactile landmarks during use.
Regarding instant claims 13, 14, and 16, claims 13, 14, and 16 of the ‘814 patent as modified recite all the limitations of instant claims 13, 14, and 16.
Regarding instant claim 17, claims 10 and 17 of the ‘814 patent as modified recite all the limitations of instant claim 17, except the limitation “a first tactile feature configured to assist a user to locate the deflation mode actuator, and a second tactile feature disposed opposite the first tactile feature, the first tactile feature including a curved surface, the second tactile feature including a curved surface, the first tactile feature being disposed on a first side of a longitudinal axis of the pump bulb, the second tactile feature being disposed on a second side of the longitudinal axis of the pump bulb”.
However, Fogarty teaches a pump assembly (3) for an inflatable penile prosthesis comprising: a valve body having one or more valves (4, 11, 12); a deflation mode actuator (13) movably coupled to the valve body; a pump bulb (8) coupled to the valve body; one or more fluid ports (ports connecting to tubing 6, 7a, 7b, [0078] and [0081]; Figure 3) coupled to the valve body; and an outer protective casing (14, 15) disposed over the valve body, the outer protective casing having a first tactile feature configured to assist a user to locate the deflation mode actuator and a second tactile feature disposed opposite the first tactile feature, the first tactile feature including a curved surface, the second tactile feature including a curved surface, the first tactile feature being disposed on a first side of a longitudinal axis of the pump bulb, the second tactile feature being disposed on a second side of the longitudinal axis of the pump bulb (“casing” 14, 15 includes ridges and depressions capable of assisting a user to locate the “actuator” 13, including a “first tactile feature” including a curved surface and a “second tactile feature” including a curved surface, given their texture as shown in Figures 1, 4a, and 13a; [0109]. The “first tactile feature” is construed as a curved surface of casing 14, 15 disposed proximate the “15” marking in Figure 4a, and the ”second tactile feature” is construed as a curved surface of casing 14, 15 proximate the “Fig. 4a” marking as shown in Figure 4a. Accordingly, both tactile features are on opposing sides of the pump bulb longitudinal axis.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer protective casing of claim 10 or 17 to include a first tactile feature configured to assist a user to locate the deflation mode actuator, and a second tactile feature disposed opposite the first tactile feature, the first tactile feature including a curved surface, the second tactile feature including a curved surface as taught by Fogarty in order to enable a user to navigate the valve body and its operation via tactile landmarks during use.
Regarding instant claims 18 and 21, claims 18 and 16 of the ‘814 patent as modified recites all the limitations of instant claims 18 and 21.
Regarding instant claims 22-24, claims 1, 10, and 17 of the ‘814 patent recites all the limitations of claims 22-24, except “the outer protective casing is formed separately from the valve body”.
However, Fogarty teaches an inflatable penile prosthesis ([0002]-[0003]; [0078]) comprising: a valve body having one or more valves (4, 11, 12); and an outer protective casing (14, 15) disposed over the valve body; wherein the outer protective casing is formed separately from the valve body ([0078]-[0081]; girdle component 14 formed in two halves and placed to intimately contact pump 3, complimentary snap ring 15 secures girdle component, [0109]; Figures 1 and 13a; see annotated Figure 4a above). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prosthesis of claims 1, 10, and 17 of the ‘814 patent to such that the outer protective casing is formed separately from the valve body, to provide additional support to the valve body (Fogarty, [0109]).
Response to Arguments
Applicant's arguments filed 9 January 2026 have been fully considered but they are not persuasive.
Applicant generally contends the claims, as amended, are not taught by the prior art (arguments, page #). The examiner does not find this argument to be persuasive, as detailed in the rejections above.
Applicant requests the double patenting rejections be held in abeyance until and unless claims are otherwise held allowable (arguments, page 6). Accordingly, the double patenting rejections have been maintained as new grounds of rejection are applied as necessitated by the amendments to the claims, as detailed above.
Conclusion
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791