Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see Remarks, filed 8/20/2026, with respect to the rejection(s) of claim(s) 1,14-16 under 35 USC 102(a)(1) in view of Smith et al. have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of WEBER et al. (WO 2019222091) and Newman et al.( US 20170079760).
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, 14 - 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14 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 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 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WEBER et al. (WO 2019222091) hereinafter WEBER et al.
WEBER et al. teaches an inflatable penile prosthesis (100) includes a fluid reservoir (102) configured to hold fluid, an inflatable member (104), and a pump assembly (106) configured to transfer the fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes a first pump (108) configured to inject the fluid into the inflatable member according to a first flow rate, and a second pump (110) configured to inject fluid into the inflatable member according to a second flow rate, where the second flow rate is less than the first flow rate.
PNG
media_image1.png
646
446
media_image1.png
Greyscale
Regarding claims 1, 15-16, WEBER et al. teaches a fluid reservoir;
an inflatable member(s); Note above annotated Fig. 4A - 404
a pump assembly configured to transfer fluid between the fluid reservoir and the inflatable member, including: Note above annotated Fig. 4A - 406
a manifold, including: Here a “manifold” is a housing holding multiple valves: Note annotated figure 4A above and paragraph [0055] The pump assembly 406 includes a plurality of valves such as a valve 430, a valve 432, and a valve 434, which are disposed within fluid passageways of the valve block or body of the pump assembly 406.
a housing; Note paragraph [0055] teaches the body of the pump assembly which is interpreted as a housing for the pump/pump assembly.
at least one valve and at least one pump positioned in a fluid passageway formed in the housing;
Note [0045] In some examples, the controller 112 is configured to control one or more valves to transition the first pump 108 and the second pump 110 between a parallel configuration and a serial configuration during different phases of the inflation cycle. The valves may be disposed in fluid passageways within a valve body or block of the pump assembly 106 and note paragraph [0055].
a first fluid port in fluidic communication with the fluid reservoir; and a second fluid port in fluidic communication with the inflatable member; Note paragraph [0055] Each of the valve 430, the valve 432, and the valve 434 includes a first port and a second port. In the closed position, fluid does not transfer between the first port and the second port. In the open position, fluid is permitted to transfer between the first port and the second.
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 paragraphs [0029] the multiple pumps are not individually controlled by the user, but are mechanically and/or programmatically controlled by a controller 112 , [0040]- [0049] , [0042] the sensor 115 is configured to sense the pressure level in the inflatable member 104 and send one or more signals to the controller 112 that indicate the pressure level in the inflatable member 104. In some examples, the sensor 115 is configured to monitor the flowrate (e.g., the flowrate in both directions). The controller 112 may control the activation (and deactivation) of the first pump 108 and the second pump 110 based on the signals received from the sensor 115.
Claim Rejections - 35 USC § 103
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 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(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WEBER et al. (WO 2019222091) hereinafter WEBER et al. in view of Newman et al.( US 20170079760) hereinafter Newman et al.
WEBER et al. teaches the claimed invention as set forth above including receiving 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 paragraph [0028] the multiple pumps are not individually controlled by the user, but are mechanically and/or programmatically controlled by a controller 112, which from the point of view of the user, the multiple pumps of the pump assembly 106 may appear as a single pump. In some examples, the user is able to program the maximum output pressure and/or the pressure profile. [0039] The sensor 115 is configured to monitor the pressure level in the inflatable member 104. In some examples, the sensor 115 is calibrated before the inflation and deflation cycle is commenced. The sensor 115 is communicatively coupled to the controller 112 such that the controller 112 can receive signals from the sensor 115. In some examples, the sensor 115 is included within the pump assembly 106. In some examples, the sensor 115 is configured to sense the amount of fluid transferred to the inflatable member 104, and send one or more signals to the controller 112 that indicate the amount of fluid that has been transferred. [0041] In some examples, the sensor 115 is configured to sense the pressure level in the inflatable member 104 and send one or more signals to the controller 112 that indicate the pressure level in the inflatable member 104. In some examples, the sensor 115 is configured to monitor the flowrate (e.g., the flowrate in both directions). The controller 112 may control the activation (and deactivation) of the first pump 108 and the second pump 110 based on the signals received from the sensor 115 such that the operator is unaware of that the pump assembly 106 includes multiple pumps operating at different times.
Weber et al. does not specifically teach the electronic control system includes a printed circuit board including a processor. However, it is noted that a programmable controller implies processing utilizing a processor that would be implemented via a hardware circuit board.
Newman et al. teaches in the same field of endeavor an apparatus and method for treating erectile dysfunction, urinary and fecal incontinence, and other medical problems treated with inflatable medical implants. Including a wirelessly controlled inflatable medical implant system which includes an external control module and an implantable module. The external control module may transmit wireless power and control signals, which are received by circuitry on a flexible printed circuit board in the implantable module. In response to the received signals, circuitry in the flexible printed circuit board may cause a motor and pump combination to transfer fluid from a reservoir in the implantable device, through tubing, and into inflatable medical implant located in the penis. The flexible printed circuit board, motor, and pump may be placed within the fluid reservoir, which provides a heat sink that prevents overheating of the implant.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Weber et al. where the electronic control system includes a printed circuit board including a processor as taught by Newman et al to enable a compact, easy to operate implant apparatus that is programmable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
HASSLER et al.( CA 2507155) teaches A remotely controlled gastric band system that is practically immune to external magnetic fields, such as from a Magnetic Resonance Imaging (MRI) machine, incorporates a bi-directional pump and fluid reservoir to adjust fluid volume for hydraulic
control of a gastric band. A piezoelectric driver (e.g., rotary actuator, linear actuator) selectively compresses and expands a metal bellows hermetically sealed within a biocompatible and nonferromagnetic enclosure or case such as titanium.
LEVIUS(WO 9204879) teaches a two-component fluid pump for inflating an inflatable penile prosthesis. The pump comprises a high-volume, low-pressure first pump component and at least one low-volume, high-pressure second pump component. Fluid to be pumped to the prosthesis is housed within the first component, and each of the first and second components is in valved communication with the prosthesis and in valved communication with each other. In a preferred embodiment the second pump component is disposed within the first pump component. The pump preferably can be implanted within the user, with the most preferable implantation site being within the scrotal sack.
Miller(US 5509888) teaches a device and method for regulating fluid flow within the human body includes small electromagnetic devices embedded in an inner housing of the present device that function under the control of a programmable control unit to create small magnetic fields which cause an artificial increase in the viscosity and apparent density of a magnetorheological fluid located in a compartment surrounding the structure through which fluid flow is to be controlled.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN L CASLER/Primary Examiner, Art Unit 3791
Prosecution Insights