DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/20/2026 has been entered.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive. Applicant argues that the amendments have overcome the prior art rejections. Examiner disagrees. As currently written Wassermann still shows a configuration where a valve is disposed between the implant/cuff and the fluid reservoir (one of the valves in figure 11 and valve 2 in figure 13), which would still meet the limitations of the claims. Amending the claim in a manner that better reflects the clear separation and exclusivity of the fluid paths such as the one shown in figure 2 where the paths do not actually connect outside of their respective endpoints would overcome the currently applied art.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2005/0240144 (Wassermann et al., hereinafter Wassermann) in view of US 2007/0265645 (Birk et al., hereinafter Birk) and US 2006/0211913 (Dlugos et al., hereinafter Dlugos).
In regards to claims 1, 2, 3, 4, 7, 8, 9, and 10, Wassermann discloses in figures 11 and 13 and describes in paragraphs 118-122 and 175-180 an apparatus with a pump, fluid reservoir, inflatable implant, a valve, implantable power supply, controller, and sensor (English version of figures is in US 7,217,237, the granted patent of the above publication).
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Both figures 11 and 13 show the presence of an inflatable cuff/implant (25), a fluid reservoir (28) coupled to the inflatable implant/cuff, a pump (27) fluidically coupled to the fluid reservoir, the pump being fluidically coupled to the inflatable cuff. A valve (26) is disposed on each fluid path and depending on the whether the valves are open or closed allows for fluid flow from the fluid reservoir (28) to the cuff (25) (the filling state) or from the cuff to the pump back to the fluid reservoir (28) (the emptying state), thus meeting the limitations of claims 3, 4, 9, and 10. Note that the claim only states the flow through the claimed paths and does not exclude flow through other paths during the filling and emptying states, which allows Wassermann to meet the limitations of the claim. The embodiments of figures 11 and 13 show that a valve (the valve on the right side fluid path in figure 11 and valve 2 in figure 13) is disposed fluidically between the implant and the fluid reservoir. It can be seen in the figures that the valve has only two fluidic connections where the first fluidic connection connects to the implant/cuff and the second fluidic connection is connected to the fluid reservoir. Wassermann discloses the presence of an implanted battery that operates the device (figure 13 of patent; paragraph 182-185), a pressure sensor that measures pressure in cuff (paragraphs 121, 162-164) and a controller (11; paragraphs 17; microprocessor in figure 13; paragraph 155, 167-172) that controls valves. However, Wassermann does not state that the pressure sensor is a voltage or current sensor and outputs a pressure feedback signal indicative of pressure of the inflatable implant/cuff and that a controller is electrically coupled to the pump and is configured to deactivate the pump based on the pressure feedback signal.
In a related area, Birk discloses the regulation of a self-adjusting gastric band, a type of implanted inflatable cuff (see title and abstract). Of note is paragraphs 61-86 which discloses the monitoring of pressure using a sensor (522) in the expandable ring, sending feedback control signals to a controller (526) and have the controller activate or deactivate of the pump when the pressure is in the desired operating range. Thus, it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device of Wassermann to include the controller and pressure sensors of Birk in order to control pressure within a cuff within a desired operating range. Wassermann and Birk do not state that the pressure sensor is a voltage or current sensor and outputs a pressure feedback signal indicative of pressure of the inflatable implant/cuff.
In a related area, Dlugos discloses a restriction device (title and abstract). Of particular note are figures 9-10 and paragraphs 60-62 which disclose the structure of a pressure sensor that detects changes in voltage, thus a voltage sensor, as one of the ways to measure fluid pressure in a restriction device and could be designed to increase sensitivity and accuracy of the pressure sensing system. Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention to use a voltage sensor as the pressure sensor as taught by Dlugos in the device of Wassermann and Birk in order to have increased sensitivity and accuracy.
In regards to claims 5, 6, and 11-12, Wassermann, Birk, and Dlugos disclose the limitations of claims 1 and 7. Birk also discloses the presence of an external controller that wirelessly transmits commands responsive to user input to the implanted controller system (paragraphs 8, 47, 53, 80, 94, 97-101) to allow for external input and provide physician feedback during device adjustment. Note that the adjustments set the pressure conditions and that the internal controller performs the procedures to maintain the desired pressure by activating or deactivating the pump as noted in paragraphs 61-86 of Birk. Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device of Wassermann, Birk, and Dlugos to include the wireless controller of Birk in order to allow for external input and provide physician feedback during device adjustment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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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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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791