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 . 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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08 April 2026 has been entered.
Claim Objections
Claims 12 and 19 are objected to because of the following informalities:
in claim 12, line 9 “the pump bulb” and in line 12 “a pump bulb” should be amended to --a pump bulb-- and --the pump bulb--, respectively; and
in claim 19 line 3 “a pump assembly” should read --the pump assembly--.
Appropriate correction is required.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,311,382 in view of Burton et al. (US Patent No. 4,682,583) (Burton). U.S. Patent No. 11,311,382 teaches the pending claims except for a refill valve disposed directly between the first port and the pump bulb. Burton teaches a pump assembly as claimed in the instant application and outlined below. It would have been obvious to one of ordinary skill in the art to provide the pump assembly of U.S. Patent No. 11,311,382 in order to control flow between the first port and the pump bulb.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. With regards to claim 1, the specification fails to provide adequate written description support for “a first fluid port configured to be fluidly coupled to the fluid reservoir, and a second fluid port configured to be fluidly coupled to the fluid reservoir” in combination with “a refill valve fluidically coupled to the first fluid port such that the refill valve is disposed directly between the first fluid port and the pump bulb”. The specification as originally filed appears to provide adequate written description support for a first fluid port (#213) configured to be fluidly couple to the inflatable member and second fluid port in the form of a fluid reservoir port, #214, that fluidly coupled to the fluid reservoir (see [0035] and [0053]) and the refill valve, #220, is coupled to the fluid reservoir port, #214, such that the refill valve, #220, is disposed directly between the second fluid port, #214, and the pump bulb, #208.
In claim 1, lines 6-7 “a first fluid port configured to be fluidly coupled to the fluid reservoir, and a second fluid port configured to be fluidly coupled to the fluid reservoir” should be amended to recite --a first fluid port configured to be fluidly coupled to the inflatable member, and a second fluid port configured to be fluidly coupled to the fluid reservoir--.
In claim 1, lines 10-11 it appears “a refill valve fluidically coupled to the first fluid port such that the refill valve is disposed directly between the first fluid port and the pump bulb” should be amended to recite --a refill valve fluidically coupled to the second fluid port such that the refill valve is disposed directly between the second fluid port and the pump bulb--.
Prior art has been applied below consistent with the arrangement of the first fluid port, second fluid port and refill valve adequately supported in the original disclosure.
Claims 2-11 are rejected due to their dependency on a rejected claim.
Claim Rejections - 35 USC § 112(b)
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.
Claims 19-20 are 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 19 recites the limitation "the bore" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claims 20 is rejected due to their dependency on a rejected claim.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Burton et al. (US Patent No. 4,682,583) in view of Fogarty et al. (US 2007/0142700 A1) (Fogarty).
Referring to claims 1, 2 and 8: Burton teaches a prosthesis (see figure 1) comprising: a fluid reservoir (see figure 1, #44) configured to hold fluid; an inflatable member (see figure 1, #16; column 3, lines 8-16); and a pump assembly (see figure 1; wherein the pump assembly is generally indicated by reference arrow #10) configured to transfer the fluid between the fluid reservoir and the inflatable member (see column 3, lines 33-40; column 4, line 52-column 5, line 24), the pump assembly including a pump bulb (see figure 1, #26), a valve body (see figure 1, #12), a push valve (see figures 5A/B; column 4, lines 10-51; wherein the push valve operates in part hydraulically to open the flow but that other types of positive lock-out valves may be utilized) movably coupled to the valve body, a first fluid port (see figure 1, #24) configured to be fluidly coupled to the inflatable member, and a second fluid port (see figure 1, #20) configured to be fluidly coupled to the fluid reservoir, the push valve including a movable valve element (see figures 5A/B, #38) configured to move between an inflation position and a deflation position within a bore (see figures 5A/B, #36a/b) of the valve body, the valve body includes a refill valve (see figure 1, #40) fluidically coupled to the second fluid port such that the refill valve is disposed directly between the second fluid port and the pump bulb (see figure 1), the refill valve including an unbiased valve member (see column 3, lines 4-7), wherein the refill valve is configured to transfer fluid from the fluid reservoir to the pump bulb (see column 3, lines 4-7), the movable valve element in the inflation position defining a fluid passageway through the bore to transfer fluid from the pump bulb to the second fluid port, the movable valve element, when moved to the deflation position, configured to change the fluid passageway through the bore to transfer fluid from the second fluid port to the first fluid port such that the pump bulb is bypassed (see column 4, lines 52-column 5, line 24).
It is noted that Burton specifically teaches an arrangement where the inflatable member (see figure 1, #16) is also acts as a reservoir and wherein the reservoir (see figure 1, #44) also acts as an inflatable artificial sphincter which is opposite to the arrangement of the inflatable member and the reservoir of the disclosed invention. Due to the breadth of the claim the interpretation of Burton above reads on the claim. However, in efforts to promote compact prosecution, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply swap the inflatable member and reservoir of Burton, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art and would have yielded predictable results in transferring fluid from the reservoir to the inflatable member without modifying the operation of the device.
Burton is silent to the prosthesis being an inflatable penile prosthesis and the push valve being a biased push valve to bias the movable valve element to in the inflation position. Fogarty teaches an inflatable penile prosthesis (see figure 1; [0078]) comprising: a fluid reservoir (see figure 1, #1; [0078]) configured to hold fluid; an inflatable penile cylinder member (see figure 1, #5a/5b; [0062]); and a pump assembly (see figure 1, #3) configured to transfer the fluid between the fluid reservoir and the inflatable member (see [0061] and [0078]), the pump assembly including a biased pushed valve (see figures 4a/b, #4). It would have been obvious to one of ordinary skill in the art to make a simple substitution of the cuff (#14) of Burton with an inflatable penile cylinder member like taught by Fogarty in order to yield predictable results in aiding in the treatment of erectile disfunction (see Fogarty [0060]).
Additionally, it would have been obvious to one of ordinary skill in the art to modify the push valve of Burton to a spring biased push valve like taught by Fogarty in order to yield predictable results in aiding in maintaining the valve in the inflate and deflate modes (see Fogarty [0082]).
Referring to claim 3: Burton further teaches the push valve includes a poppet (see column 3, lines 40-50) having a ring member (see figures 5A/B, #58).
Referring to claim 4: Burton further taches the movable valve element is configured to move to the deflation position in a linear direction based on a single instantaneous push of the movable valve element by a user (see column 4, lines 22-36).
Referring to claim 5: Burton further teaches the pump assembly includes a button component (see figures 5A/B, #56) that encloses a portion of the movable valve element when the movable valve element is in the inflation position.
Referring to claim 6: Burton further teaches the pump assembly includes a feedback component (see figure 5A, #50/55) disposed between the button component and the movable valve element, the feedback component configured to provide at least one of tactile or auditory feedback in response to the movable valve element being moved to the deflation position (see column 3, line 41-column 4, line 21; wherein when the radially extending surface, #55, of the poppet passes #50 a tactile feedback would be provided to the user).
Referring to claim 7: Burton further teaches portion of the movable valve element extends outside the valve body when the movable valve element is in the inflation position, the portion of the movable valve element being disposed inside the valve body when the movable valve element is in the deflation position (see figures 5A/B).
Referring to claim 9: Burton further teaches the valve body includes an inflation valve (see figure 1, #32) disposed in a fluid passageway between the pump bulb and the bore.
Referring to claim 10: Burton further teaches the movable valve element includes a first movable member (see figure 5A, #52) and a second movable member (see figure 5A, #54).
Referring to claim 11: Burton further teaches the valve body includes an inflation valve (see figure 1, #32), wherein the refill valve and the inflation valve are not used when the movable valve element is in the deflation position (see column 4, lines 52-column 5, line 24).
Referring to claim 12: Burton further teaches a pump assembly fully capable of use in an inflatable penile prosthesis comprising: a push valve (see figures 5A/B; column 4, lines 10-51; wherein the push valve operates in part hydraulically to open the flow but that other types of positive lock-out valves may be utilized) movably coupled to a valve body (see figure 1, #12), the push valve including a movable valve element (see figures 5A/B, #38) configured to move between an inflation position and a deflation position within a bore (see figures 5A/B, #36a/b) of the valve body; a plurality of fluid transfer ports including a first fluid port (see figure 1, #20) configured to be fluidly coupled to a fluid reservoir (see figure 1, #44), and a second fluid port (see figure 1, #24) configured to be fluidly coupled to an inflatable member (see figure 1, #16); and a refill valve (see figure 1, #40) fluidically coupled to the first fluid port such that the refill valve is disposed directly between the first fluid port and a pump bulb (see figure 1, #26), the refill valve including an unbiased valve member (see column 3, lines 4-7), the movable valve element in the inflation position defining a fluid passageway through the bore to transfer fluid from a pump bulb to the second fluid port, the movable valve element, when moved to the deflation position, configured to change the fluid passageway through the bore to transfer fluid from the second fluid port to the first fluid port such that the pump bulb is bypassed (column 4, lines 52-column 5, line 24).
It is noted that Burton specifically teaches an arrangement where the inflatable member (see figure 1, #16) is also acts as a reservoir and wherein the reservoir (see figure 1, #44) also acts as an inflatable artificial sphincter which is opposite to the arrangement of the inflatable member and the reservoir of the disclosed invention. Due to the breadth of the claim the interpretation of Burton above reads on the claim. However, in efforts to promote compact prosecution, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply swap the inflatable member and reservoir of Burton, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art and would have yielded predictable results in transferring fluid from the reservoir to the inflatable member without modifying the operation of the device.
Burton is silent to the push valve being biased. Fogarty teaches an inflatable penile prosthesis (see figure 1; [0078]) comprising: a fluid reservoir (see figure 1, #1; [0078]) configured to hold fluid; an inflatable penile cylinder member (see figure 1, #5a/5b; [0062]); and a pump assembly (see figure 1, #3) configured to transfer the fluid between the fluid reservoir and the inflatable member (see [0061] and [0078]), the pump assembly including a biased pushed valve (see figures 4a/b, #4). It would have been obvious to one of ordinary skill in the art to modify the push valve of Burton to a spring biased push valve like taught by Fogarty in order to yield predictable results in aiding in maintaining the valve in the inflate and deflate modes (see Fogarty [0082]).
Referring to claim 13: Burton further teaches the movable valve element includes a cylindrical unitary body having at least two sections (see figure 5A, #52/54) with different diameters (see column 3, lines 60-68).
Referring to claim 14: Burton, as modified above, further teaches the first fluid port includes a first tubular member (see figure 1, #18) couple to the fluid reservoir (#16), and the second fluid port includes a second tubular member (see figure 1, #22) coupled to the cuff (#14) which includes the inflation member (#44). Burton, as modified by Fogarty, is silent to a third tubular member, the second tubular member configured to be fluidly coupled to a first cylinder member of the inflatable member, the third tubular member configured to be fluidly coupled to a second cylinder member of the inflatable member.
Fogarty further teaches the inflatable penile prosthesis comprising the first fluid port including a first tubular member (see figure 1, #6) coupled to the fluid reservoir (see figure 1, #1), and the second fluid port including a second tubular member (see figure 1, #7a) and a third tubular member (see figure 1, #7b), the second tubular member configured to be fluidly coupled to a first cylinder member (see figure 1, #5a) of the inflatable member, the third tubular member configured to be fluidly coupled to a second cylinder member of the inflatable member (see figure 1, #5b). ). It would have been obvious to one of ordinary skill in the art to make a simple substitution of the singular tubular member fluidly coupled to the cuff (#14) of Burton with first and second tubular members fluidly coupled to first and second inflatable penile cylinder member, respectively, like taught by Fogarty in order to yield predictable results in aiding in the treatment of erectile disfunction (see Fogarty [0060]).
Referring to claim 15: Burton further teaches an inflation valve (see figure 1, #32) disposed in a fluid passageway between the bore and the pump bulb.
Referring to claim 16: Burton further teaches the movable valve element is configured to move from the inflation position to the deflation position along an axis (see figures 5A/B), the axis being substantially orthogonal to the longitudinal axis of the first fluid port (see figure 3).
Referring to claim 17: Burton further teaches an anti-auto inflate valve (see figure 1, #34) disposed in a fluid passageway between the first fluid port and the second fluid port.
Referring to claim 18: Burton further teaches a portion of the movable valve element extends outside the valve body when the movable valve element is in the inflation position (see figures 5A/B), the pump assembly further comprising: a button component (see figures 5A/B, #56) that encloses the portion of the movable valve element; and a feedback component (see figure 5A, #50/55) disposed between the button component and an end portion of the movable valve element, the feedback component configured to provide at least one of tactile or auditory feedback in response to the movable valve element being moved to the deflation position (see column 3, line 41-column 4, line 21; wherein when the radially extending surface, #55, of the poppet passes #50 a tactile feedback would be provided to the user).
Referring to claim 19: Burton teaches a method for controlling a direction of fluid through a pump assembly (see figure 1; wherein the pump assembly is generally indicated by reference arrow #10) of an inflatable prosthesis, the method comprising: transferring, by the pump assembly, fluid from a fluid reservoir (see figure 1, #44) to an inflatable member (see figure 1, #16), including: transferring the fluid from the fluid reservoir to a pump bulb (see figure 1, #26) via a refill valve (see figure 1, #40), the refill valve being disposed directly between the fluid reservoir and the pump bulb (see figure 1); transferring the fluid from the pump bulb to the inflatable member via an inflation valve (see figure 1, #32) and a push valve (see figures 5A/B; column 4, lines 10-51) having a movable valve element (see figures 5A/B, #38); pushing the movable valve element along an axis to a deflation position to change a fluid passageway through a valve body (see figure 1, #12) of the pump assembly (see figures 5A/B; column 4, lines 22-36; and column 4, lines 52-column 5, line 24); and transferring the fluid from the inflatable member to the fluid reservoir via the push valve such that the fluid is transferred through the bore and an anti-auto inflate valve (see figure 1, #34) disposed within a fluid passageway that extends between the bore and the fluid reservoir and such that the fluid is not transferred through the pump bulb (see figures 5A/B and column 4, lines 52-column 5, line 24).
It is noted that Burton specifically teaches an arrangement where the inflatable member (see figure 1, #16) is also acts as a reservoir and wherein the reservoir (see figure 1, #44) also acts as an inflatable artificial sphincter which is opposite to the arrangement of the inflatable member and the reservoir of the disclosed invention. Due to the breadth of the claim the interpretation of Burton above reads on the claim. However, in efforts to promote compact prosecution, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply swap the inflatable member and reservoir of Burton, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art and would have yielded predictable results in transferring fluid from the reservoir to the inflatable member without modifying the operation of the device.
Burton is silent to the prosthesis being an inflatable penile prosthesis and the push valve including a biasing member. Fogarty teaches an inflatable penile prosthesis (see figure 1; [0078]) comprising: a fluid reservoir (see figure 1, #1; [0078]) configured to hold fluid; an inflatable penile cylinder member (see figure 1, #5a/5b; [0062]); and a pump assembly (see figure 1, #3) configured to transfer the fluid between the fluid reservoir and the inflatable member (see [0061] and [0078]), the pump assembly including a biased pushed valve (see figures 4a/b, #4). It would have been obvious to one of ordinary skill in the art to make a simple substitution of the cuff (#14) of Burton with an inflatable penile cylinder member like taught by Fogarty in order to yield predictable results in aiding in the treatment of erectile disfunction (see Fogarty [0060]).
Additionally, it would have been obvious to one of ordinary skill in the art to modify the push valve of Burton to a spring biased push valve like taught by Fogarty in order to yield predictable results in aiding in maintaining the valve in the inflate and deflate modes (see Fogarty [0082]).
Referring to claim 20: Burton further teaches the refill valve and the inflation valve are not used to transfer the fluid from the inflation member to the fluid reservoir when the movable valve element is in the deflation position (see column 4, lines 52-column 5, line 24).
Response to Arguments
Applicant’s arguments presented 08 April 2026 with respect to claims 1-20 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.
Conclusion
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/KAYLEE R WILSON/Primary Examiner, Art Unit 3700
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