DETAILED ACTION
This Office Action is in response to Applicant’s Amendment filed on 03/02/2026.
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 .
Claim Objections
Following claims are objected to because of the following informalities:
Claim 19 lines 12-13 “transferring the fluid from the inflatable member to the fluid reservoir via the bi- directional valve such that the fluid is not transferred through the pump bulb” needs to be corrected. A suggested correction is --transferring the fluid from the inflatable member to the fluid reservoir via the bi- directional valve [[such]] in a manner that the fluid is not transferred through the pump bulb—to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “such that” is even required or not required.
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.
Claims 1-11 and 19-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 in line 10 recites “a first deflation button” which in light of claim 7 and instant application specification as-filed [0040] renders the claim unclear. More specifically, in the context used, it is unclear if claim 1 line 10 “first deflation button” is the functionally and/or structurally same as, different than or in addition to “deflation mode actuator” recited in claim 1 line 5-6. Further, if different, then in what way the two differ as they appear to be performing the same function of actuating. Additionally, when interpreted in light of instant application specification as-filed [0040] (“the deflation mode actuator 112 includes a deflation button…In some examples, the deflation mode actuator 112 includes a push rod”), claim recites both a genus deflation mode actuator and a species of the genus “a first deflation button” in the same claim and thus raises a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim1 recites the broad recitation “deflation mode actuator”, and the claim also recites “deflation button” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Lastly, claim 1 is also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting structural cooperative relationships of elements, such omission amounting to a gap between the structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structural and functional cooperative relationship between “deflation mode actuator”, and the claim also recites “first deflation button” i.e. it is unclear how the two are related to each other functionally and structurally to perform the deflation function as recited. Dependent claims 2-6, 8-11 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112 (b) issue in their respective base claims. Consequently, dependent claims 2-6, 8-11 are also rejected under 35 U.S.C. 112(b) based in their direct/indirect dependency on their respective base claims. Examiner suggests merging claim 7 subject-matter into claim 1 to cure this noted issue.
Claim 19 in line 11 recites “a deflation mode actuator” which in light of instant application specification as-filed [0040] renders the claim unclear. More specifically, in the context used, it is unclear if claim 19 line 11 “a deflation mode actuator” is functionally and/or structurally same as, different than or in addition to “first deflation button” recited in claim 19 line 5. Further, if different, then in what way the two differ as they appear to be performing the same function of actuating. Additionally, when interpreted in light of instant application specification as-filed [0040] (“the deflation mode actuator 112 includes a deflation button…In some examples, the deflation mode actuator 112 includes a push rod”), claim recites both a genus deflation mode actuator and a species of the genus “a first deflation button” in the same claim and thus raises a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) and may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 19 recites the broad recitation “deflation mode actuator”, and the claim also recites “deflation button” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Lastly, claim 19 is also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting structural cooperative relationships of elements, such omission amounting to a gap between the structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structural and functional cooperative relationship between “deflation mode actuator”, and the claim also recites “first deflation button” i.e. it is unclear how the two are related to each other functionally and structurally to perform the deflation function as recited. Examiner suggests further including subject-matter as in suggested for claim 1 above to cure this noted issue. Dependent claim 20 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112 (b) issue in their respective base claims. Consequently, dependent claim 20 is also rejected under 35 U.S.C. 112(b) based in their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification para. [0025-0026], [0040], [0042].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
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 1-13 and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 11,549,598 B2 (U.S. Patent Application No. 16/680,141). Although the claims 1-20 at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to species and thus, anticipate the more generic or broader claims now pending (instant Claims 1-13 and 15-18). That is, the rationale of In re Goodman applies here in that once Applicant has received a patent for a species or a more specific embodiment, Applicant is not entitled to a patent for the generic or broader invention without maintaining common ownership and ensuring that the term of the latter issued patent will expire at the end of the original term of the earlier issued patent. For example claim 1 under examination is anticipated by species recited in patented claim 7, claim 12 under examination is anticipated by species recited in patented claim 14. Similarly the dependent claims under examination are anticipated by correspondingly numbered species patented dependent claims.
Contingently Allowable Subject-Matter
As per independent claim 19, independent claim 19 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action in addition to overcoming any other rejections/objections enumerated above.
As per dependent claim 20, dependent claim 20 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and by further including all of the limitations of the base claims and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
Additionally, as per dependent claim 20, dependent claim 20 is being objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per independent Claim 19, none of the prior art discloses a method for controlling a direction of fluid through a pump assembly of an inflatable penile prosthesis… comprising:
transferring, by a pump assembly, fluid from a fluid reservoir to an inflatable member, a valve body including a first surface and a second surface opposite the first surface, the valve body includes a first deflation button extending from the first surface and a second deflation button extending from the second surface, including: transferring the fluid from the fluid reservoir to a pump bulb via a refill valve; transferring the fluid from the pump bulb to the inflatable member via an inflation valve and a bi-directional valve; moving the bi-directional valve to a deflation position based on activation of a deflation mode actuator; and transferring the fluid from the inflatable member to the fluid reservoir via the bi- directional valve… that the fluid is not transferred through the pump bulb including all the other features, steps, specific arrangement and combination of features and steps in independent Claim 19.
Prior art WO 2011057642 A1 to Morningstar Randy L discloses a pump provided for a body implantable prosthesis that includes a reservoir maintaining a fluid volume that is transferrable into a cylinder. The pump includes a pump bulb, an inlet valve, an exhaust valve, and an anti-auto inflation (AAI) valve. The pump bulb is connected to a pump body that is in fluid communication with the reservoir and the cylinder. The inlet valve is operable to allow a portion of the fluid volume to be drawn from the reservoir and delivered into the pump bulb. The exhaust valve is operable to allow the portion of the fluid volume delivered into the pump bulb to be pumped into the cylinder. The AAI valve is disposed in the pump body and has a seal that is biased to prevent fluid flow from bypassing the pump bulb and flowing from the reservoir to the cylinder.
Prior art US 8337392 B2 to Morningstar discloses a pump connected to a body implantable penile prosthesis including a reservoir maintaining a fluid volume that is transferrable into a cylinder of the penile prosthesis. The pump includes a pump bulb connected to a pump body that is in fluid communication with the reservoir and the cylinder; an inlet valve operable to allow a portion of the fluid volume to be drawn from the reservoir and delivered into the pump bulb; an exhaust valve operable to allow the portion of the fluid volume delivered into the pump bulb to be pumped into the cylinder; and an anti-autoinflation (AAI) valve disposed in the pump body and comprising a seal that is biased to prevent fluid flow from bypassing the pump bulb and flowing from the reservoir to the cylinder.
Prior art US 4782826 A to Fogarty discloses penile implant that includes an elongated member for implantation in the penis that is in fluid communication with a reservoir. The member includes an enclosure having a pressurizable chamber section such that the member is transformable between a flaccid and an erect state and a pump for transferring fluid from the reservoir to the pressurizable chamber. The pump has a valve portion made of a deformable material such that when the valve portion is deformed, fluid flows from the pressurizable chamber to the reservoir making the member flaccid. The valve portion is surrounded by a cushioning material to protect the valve portion from being accidentally deformed, permitting fluid to flow from the pressurizable chamber back to the reservoir.
Prior art US 8257246 B1 to Fogarty discloses a pump that includes a pump body and a pump bulb that is connected to the pump body, an inlet valve assembly, and an exhaust valve assembly. The pump bulb is operable to move fluid between the reservoir and the cylinder. The inlet valve assembly includes a valve and a tubular sleeve that provides an exit valve seat. The inlet valve assembly is operable to allow a portion of fluid to be drawn from the reservoir through the tubular sleeve and through the inlet channel for delivery into the pump bulb. The exhaust valve assembly is operable to allow the portion of the fluid delivered into the pump bulb to be moved into the cylinder. The valve is movable to contact the exit valve seat and prevent fluid that is flowing from the cylinder to the reservoir from flowing through the inlet channel.
Prior art US 20030100929 A1 to Forsell discloses a male sexual impotence treatment prosthesis apparatus, comprising an operable penile prosthesis implantable in the cavities of the corpora cavernosa of a patient's penile tissue to provide erect penile condition, when the prosthesis is operated.
Prior art US 20030114729 A1 to Forsell discloses male impotence treatment apparatus that comprises an adjustable prosthesis device implanted in an impotent patient that engages the corpus cavernosum or penile tissue of the patient to provide flaccid or erect state of the penis.
Prior art US 20080114202 A1 to Kuyava et al. discloses inflatable penile prosthesis that includes an implantable pump having a valve. The valve includes a cavity having a valve seat at a port, a poppet and a spring. The poppet includes a valve member and a stem extending from the valve member. In operation, the poppet includes a sealing position, where the valve member seals the port through contact with the valve seat, and a deflating position, where the valve member is displaced from the valve seat. The spring is configured to bias the valve member toward the valve seat, wherein the spring engages a portion of the stem while the poppet is in the deflating position.
Prior art US 20150359655 A1 to Daniel; Geoffrey discloses a pump that includes a pump bulb connected to a pump body. An exhaust valve assembly is disposed in the pump body within an exit flow path communicating between the pump bulb and the cylinder. An inlet valve is rotatably disposed in the pump body within an inlet flow path communicating between the reservoir and the pump bulb. The inlet valve includes a spherical part retained in a seat formed by the pump body, an inlet flange connected to and extending radially away from the spherical part, and a lockout flange connected to and extending radially away from the spherical part. A channel is formed through a portion of the spherical part of the inlet valve. The channel includes an outlet hole that is blocked from the inlet flow path by the seat formed in the pump body and opened to the inlet flow path by rotation of the inlet valve.
Prior art US 5010882 A to Polyak et al. discloses a penile prosthesis implantable within the corpus cavernosum of the penis in order to alleviate erectile impotency includes a valve mechanism for returning the prosthesis from the erect to the flaccid state. The prosthesis is of a unitary type comprising a distal portion including a pump, a medial portion defining a pressurizable chamber comprising an internal, tubular, substantially non-distensible portion and a concentric tubular sleeve, and a proximal portion including a fluid reservoir, the latter being in fluid communication with the pump. The deflation valve mechanism is activated in accordance with pressure differential conditions within the valve and a movable or distensible partition capable of exerting an internal force within the valve to place the valve in an open mode, thereby effecting the deflation of the prosthesis or hydraulic system in which the valve mechanism is present. Apparatus for extending the length of the prosthesis are also provided.
Prior art US 6171233 B1 to Willard discloses a valve for an inflatable penile prosthesis which responds to internal fluid pressure. The valve is a lockout valve and comprises a housing having inlet and outlet ports, an interior chamber, an apertured valve seat, and a poppet biased toward the closed position. The inlet communicates with the prosthesis reservoir, and the outlet communicates with the interior chamber and the prosthesis pump. The housing includes a flexible diaphragm which moves toward the poppet when flexed inwardly. Fluid pressure through the inlet port urges the poppet into sealing engagement against the valve seat, therefore closing the lockout valve. Negative fluid pressure applied to the interior chamber from the outlet port (when the pump is actuated) causes the diaphragm to flex inwardly and contact the poppet to open the valve. The lockout valve operates like a check valve when subject to reverse flow.
Additionally, as per dependent claim 20, dependent claim 20 would be contingently allowable based on their direct/indirect dependency on contingently allowable respective base claims
Response to Amendment
According to the Amendment, filed 03/02/2026, the status of the claims is as follows:
Claims 1, 3-7, 9, 11-13, 15-20 are currently amended;
Claims 2, 8, 10 are as originally filed; and
Claim 14 is cancelled.
By the current amendment, as a result, claims 1-13, 15-20 are now pending in this application and are being examined on the merits.
Response to Arguments
Issues Raised and Arguments/Remarks to Rejections/Objections Not Based On Prior Art presented on Page 7 of Applicant’s Amendment dated 03/02/2026
[A]: The Examiner agrees with the Applicant, and in light of the amendments/arguments, withdraws the following non prior art related objections/rejections raised in Office Action dated 12/02/2025: [1] The objection to claims is withdrawn in view of the amendment and arguments, filed 03/02/2026; [2] Claims 19-20 rejection on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 11,549,598 B2 (U.S. Patent Application No. 16/680,141) is withdrawn in in view of the amendment and arguments, filed 03/02/2026.
[B]: The Examiner disagrees with the Applicant, and in light of the amendments/arguments, maintains the following non prior art related objections/rejections raised in Office Action dated 12/02/2025: [1] Claims 1-13, 15-18 rejection on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 11,549,598 B2 (U.S. Patent Application No. 16/680,141) is maintained in view of the amendment and arguments, filed 03/02/2026 as claims 1-13, 15-18 are still rejectable on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 11,549,598 B2.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 7 of Applicant’s Amendment dated 03/02/2026 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 102/103 Rejection of Claims 1-13, 15-20[A] Claims 1, 6, 8-13, 15 and 18-20 were rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Morningstar Randy L (Pub. No.: WO 2011057642 Al, hereinafter referred to as "Morningstar").
[B] Claims 2-3 and 16 were rejected under 35 U.S.C. 103 as being unpatentable over Morningstar. Independent claims 1, 12, and 19 have been amended as shown above. It does not appear that the cited references disclose such a device or method.
[C] Accordingly, it is respectfully submitted that the independent claims and the claims that depend therefrom are allowable.
Applicant’s arguments [A-C] above with respect to the above claim limitations in amended independent claim have been considered and are persuasive. Therefore, claims 1-13, 15-20 rejection as explicitly, positively and specifically raised by the Applicants in Office Action dated 12/02/2025 are withdrawn.
However, Examiner notes claims 1-13, 15-20 are allowable at this time due to double patenting issues which were not cured as Applicant’s did not file a Terminal Disclaimer at this time and also due to 35 U.S.C 112(b) that are enumerated above.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (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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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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