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 .
Election/Restrictions
Claims 2-13 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/20/2026.
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, 15 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 17655952 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims represent an obvious variation or broadening of the scope. Both applications include a “manifold” including a housing with at least one valve and multiple ports, a fluid reservoir, an inflatable member and a fluid control system and electronic control system.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 17655952 in view of Smith et al. (US 20200222188) hereinafter Smith et al.
Regarding claim 14, copending Application No. 17655952 teaches the subject matter of claim 1 but does not teach wherein the electronic control system includes a printed circuit board including a processor configured to: receive pressure level measurements from the at least one sensing device;
apply a control algorithm based on the received pressure level measurements; and control operation of the at least one valve and the at least one pump in accordance with the applied control algorithm.
Smith et al. teaches wherein the electronic control system includes a printed circuit board including a processor configured to: receive pressure level measurements from the at least one sensing device; apply a control algorithm based on the received pressure level measurements; and control operation of the at least one valve and the at least one pump in accordance with the applied control algorithm. Note [0042] The electronic control module 213 is configured to control the first electronically powered pump 208, the second electronically powered pump 210, the first valve 212, and/or the second valve 214. The electronic control module 213 may include one or more processors (e.g., coupled to a substrate) and a non-transitory computer readable medium that stores instructions executable by processors.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in copending Application No. 17655952 the control system and program/algorithm for controlling the pump and valves as taught by Smith et al. to better control the fluid and pressure within the implanted system.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1 and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US 20200222188) hereinafter Smith et al.
Smith et al. teaches an implantable device includes a fluid reservoir configured to be implanted in a body of a patient at a first location, an inflatable member configured to be implanted in the body of the patient at a second location, and a pump assembly configured to be implanted in the body of the patient at a third location. The pump assembly is configured to transfer fluid from the fluid reservoir to the inflatable member in response to the implantable device being in an inflation mode, and the pump assembly configured to transfer the fluid from the inflatable member to the fluid reservoir in response to the implantable device being in a deflation mode. The pump assembly includes an electronic control module, an electronically powered pump, a first valve, and a second valve. The electronic control module is configured to activate or deactivate the electronically powered pump.
Regarding claims 1 and 15, Smith et al. teaches a fluid reservoir;
an inflatable member; a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member, including: a manifold, including: a housing; at least one valve and at least one pump positioned in a fluid passageway formed in the housing; a first fluid port in fluidic communication with the fluid reservoir; and a second fluid port in fluidic communication with the inflatable member; an electronic control system controlling operation of the pump assembly; and
at least one pressure sensing device in communication with the electronic control system. Note Fig. 1 and paragraphs [0022] –[0032], [0022] The implantable device 100 includes a fluid reservoir 102, an inflatable member 104, and a pump assembly 106 configured to transfer fluid between the fluid reservoir 102 and the inflatable member 104. The fluid reservoir 102 is configured to be implanted in a body of a patient at a first location. In some examples, the first location is an abdomen of the patient. In some examples, the first location is a pelvic cavity of the patient. The inflatable member 104 is configured to be implanted in the body of the patient at a second location. In some examples, the second location is the corpus cavernosae of the patient. In some examples, the second location is around a urethra of the patient. The pump assembly 106 is configured to be implanted in the body of the patient at a third location. In some examples, the third location is the scrotum of the patient. [0029] The electronic control module 113 is configured to electronically activate and deactivate the electronically powered pump 108 and/or the secondary electronically powered pump 110. The electronically powered pump(s) are configured to transfer the fluid from the fluid reservoir 102 to the inflatable member 104 when the implantable device 100 is in an inflation mode, and transfer the fluid from the inflatable member 104 to the fluid reservoir 102 when the implantable device 100 is in a deflation mode. The valves are configured to control the flow of the fluid through the valve body 122 in the inflation mode and the deflation mode. In some examples, the electronic control module 113 is communicatively coupled to an interface element 111. In some examples, the interface element 111 is a component that is operated by a patient to inflate and/or deflate the inflatable member 104. In some examples, the interface element 111 includes a button, switch, or a push rod, or other patent interface element(s) that control operation(s) of the implantable device 100. [0031] In some examples, the pump assembly 106 (or the implantable device 100) includes a pressure sensor 118 configured to monitor (or sense) a pressure of the inflatable member 104. The pressure sensor 118 is communicatively coupled to the electronic control module 113. The electronic control module 113 configured to deactivate the electronically powered pump 108 and/or the secondary electronically powered pump 110 in response to the pressure of the inflatable member 104 exceeding a threshold level. In some examples, the pressure sensor 118 (or a separate pressure sensor) is configured to monitor (or sense) the pressure of the fluid reservoir 102, and the electronic control module 113 is configured to determine a pressure differential across the pump assembly 106 based on the sensed pressure of the fluid reservoir 102 and the sensed pressure of the inflatable member 104. [0026] The pump assembly 106 is coupled to the fluid reservoir 102 via a first conduit connector 103( first fluid port), and the pump assembly 106 is coupled to the inflatable member 104 via a second conduit connector 105 ( second fluid port). Each of the first conduit connector 103 and the second conduit connector 105 may define a lumen configured to transfer the fluid to and from the pump assembly 106.
Regarding claim 14, Smith et al. teaches wherein the electronic control system includes a printed circuit board including a processor configured to: receive pressure level measurements from the at least one sensing device; apply a control algorithm based on the received pressure level measurements; and control operation of the at least one valve and the at least one pump in accordance with the applied control algorithm. Note [0042] The electronic control module 213 is configured to control the first electronically powered pump 208, the second electronically powered pump 210, the first valve 212, and/or the second valve 214. The electronic control module 213 may include one or more processors (e.g., coupled to a substrate) and a non-transitory computer readable medium that stores instructions executable by processors.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Albrecht et al. (US 20100114149) teaches implant for placement within a hollow body organ, the implant includes a distension device having an undeployed shape for delivery within a hollow body and one or more deployed shapes for implantation therein. The device has sufficient rigidity in its deployed shape to exert an outward force against an interior of the hollow body so as to bring together two substantially opposing surfaces of the hollow body. The implant further includes an implantable pump in fluid communication with the distension device and having a plurality of actuators configured to change the shape of the distension device upon the application of energy thereto such that sequential activation of the plurality of actuators is effective to create pumping action to move fluid through the pump. [0029] In one embodiment, the implantable pump effects a pressure change within the distension device in accordance with a programmed schedule. [0030] Further disclosed herein are methods for adjusting pressure in an implantable distension device. In one embodiment, the method can include sensing a clinically relevant parameter, adjusting a pressure within the distension device in response to the sensed clinically relevant parameter by activating a pump in fluid communication with the distension device. In one embodiment, the pump can be formed of a plurality of actuators configured to change shape upon the application of energy thereto such that sequential activation of the plurality of actuators is effective to create pumping action to move fluid through the pump. The sensing of the clinically relevant parameter can be effected using an implantable sensor. The clinically relevant parameter can be a pressure, in which case, the implantable sensor is a pressure sensor. In such an embodiment, the sensed pressure is compared to a desired pressure range and the pressure within the distension device is adjusted to be approximately within the desired pressure range if the sensed pressure is not within a desired pressure range. In one embodiment, the pump can be automatically activated, although other activation techniques
Tal et al. (CN 108601657) teaches penile prosthesis which can be implanted in the penis, and it comprises an inflatable tubular member and the fluid reservoir. The penile prosthesis of the invention achieve penile erection when the fluid flow entering and inflating the inflatable tubular member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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