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 .
Claim Rejections - 35 USC § 112
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 13 - 15 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.
In Regards to Claim 13: The phrase “pressure currently prevailing” stated to be different from the stored pressure, due to the method step of comparing the stored pressure to the pressure currently prevailing. Examiner interprets stored pressure to be a pressure taken from a previous point in time when the actuating process has been completed and the pressure currently prevailing to be the pressure currently existing in the system.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 - 6, 12, & 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/205,883 hereinafter Hohlrieder.
In regards to Claim 1: A device comprising:
a liquid balloon (Hohlrieder, Figure 6 Item 3);
a pump unit connected to the liquid balloon via a first connecting line for pumping liquid into the liquid balloon and for pumping liquid out of the liquid balloon (Hohlrieder, Figure 1 Item 9 &10);
an electric motor for driving the pump unit (Hohlrieder, 1 Item 15);
a battery for supplying power to the electric motor (Hohlrieder, 1 Item 18);
an electronic control unit configured to control the electric motor (Hohlrieder, Figure 1 Item 20); and
a manual operating unit for removing liquid from the liquid balloon and for pumping liquid back into the liquid balloon, the manual operating unit including a flexible pump body which is connected to the liquid balloon via a second connecting line (Hohlrieder, Figure 1 Item 25).
In regards to Claim 2: The device as claimed in claim 1, wherein the motor-operated pump unit has a receiving space that is fillable with liquid and a volume of which is changeable by moving an actuating part of the pump unit using the electric motor (Hohlrieder, Figure 1 & 2 Items 12 & 14)
In regards to Claim 3: The device as claimed in claim 2, wherein the pump unit has a bellows within which the receiving space for the liquid is situated, and an end piece of the bellows is rigidly connected to the actuating part (Hohlrieder, Figure 1 item 11 & 14).
In regards to Claim 4: The device as claimed in claim 2, further comprising at least one pressure sensor for detecting a pressure of the liquid in the receiving space (Hohlrieder, Figure 1 Item 22).
In regards to Claim 5: The device as claimed in claim 4, wherein the pressure sensor has at least one strain gauge attached to an end membrane which delimits an interior of the bellows in an axial direction of the bellows (Hohlrieder, Figure 1 Item 22) (Hohlrieder, Page 3 Paragraph 9, 13, &14, The strain gauge attached to a membrane can become a pressure sensor adjacent to a fluid.).
In regards to Claim 6: The device as claimed in claim 5, further comprising an air pressure sensor configured to detect atmospheric pressure (Hohlrieder, figure 1 Item 23) and a housing air pressure sensor configured to detect an air pressure in a gas-tight-insulated interior of a housing in which the pump unit is arranged, and the electronic control unit (Hohlrieder, Figure 1 Item 20) is configured for determining a pressure of the liquid in the receiving space (Hohlrieder, Figure 1 Item 12) of the pump unit by subtracting the atmospheric pressure which is detected by the air pressure sensor from a measured value which is output by the pressure sensor and adding the air pressure in the housing which is detected by the housing air pressure sensor (Hohlrieder, Page 3 paragraph 9).
In regards to Claim 12: The device as claimed in claim 1, wherein the device forms an artificial sphincter, the liquid balloon comprises a flexible band which is closable to form a ring (Hohlrieder, Figure 1 Item 1; Figure 5 & 6) and has a longitudinally running inner chamber which is fillable with the liquid (Hohlrieder, Figure 5 & 6 Item 3 &1a), and a passage opening of the liquid balloon which is closed to form a ring is reducible in size by reducing a volume of the pump body (Hohlrieder, figures 1 Vs. 2 Items 1 &11).
In regards to Claim 13: A method for operating a device as claimed in claim 2, the method comprising storing a pressure of the liquid in the receiving space (Hohlrieder, Figure 1 Item 12) of the motorized pump unit (Hohlrieder, Figure 1 Item 10) in the control unit after completion of a respective actuating process of the actuating part (Hohlrieder, Figure 1 Item 14) that was executed by the electronic control unit (Hohlrieder, Figure 1 Item 20)and comparing the stored pressure with a pressure currently prevailing in the receiving space before carrying out a further actuating process (Hohlrieder, Page 7 Paragraph 9).
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder in view of US 2010/0094469 hereinafter Gunnarsson.
In regards to Claim 15: Hohlrieder teaches all of claim 1, 2 & 13 and the control unit (Hohlrieder, Figure 1 Item 19) that shows a relationship between a position of the actuating part (Hohlrieder, Figure 1 Item 14) and the pressure of the liquid in the receiving space (Hohlrieder, Figure 1 Item 12). However, Hohlrieder does not teach storing a characteristic curve in the control unit that shows a relationship between a position of the actuating part and the pressure of the liquid in the receiving space, and using the characteristic curve for determining a target position of the actuating part, and the characteristic curve is a straight line with a gradient stored by the control unit.
Gunnarsson teaches storing a characteristic curve in the control unit that shows a relationship between a position of the actuating part and the pressure of the liquid in the receiving space and using the characteristic curve for determining a target position of the actuating part, and the characteristic curve is a straight line with a gradient stored by the control unit. (Gunnarsson, Paragraph 0014) (Gunnarsson, Figure 1 Items 14 & 18)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the method of storing the actuating characteristic curve as taught by Gunnarsson to the medical device taught by Hohlrieder, the motivation being to provide a way to ensure that the device maintains consistency with each actuation to prevent any bodily harm.
Claim(s) 7 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder in view of US 2005/0277974 hereinafter Hassler.
In regards to Claim 7: Hohlrieder teaches all of Claim 1, But does not teach a travel sensor for detecting the position of the actuating part.
Hassler teaches a travel sensor for detecting the position of the actuating part (Hassler, Claim 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the position sensor taught by Hassler to the medical device taught in Hohlrieder, the motivation being to provide data concerning how much distance the actuator has travel for use in comparison with the system’s pressure sensors.
In regards to Claim 14: Hohlrieder teaches all of claims 1 and 13, and where the actuating process comprises travel control of the actuating part for approaching a target position of the actuating part (Hohlrieder, Figure 1 Item 14). Hohlrieder does not teach detecting a respective position of the actuating part using a travel sensor, and, after the travel control, checking whether the pressure of the liquid in the receiving space of the motor-operated pump unit lies within a permissible filling pressure range around the second filling pressure, and if the pressure of the liquid in the receiving space lies outside the permissible filling pressure range around the second filling pressure, adjusting the position of the actuating part.
Hassler teaches detecting a respective position of the actuating part using a travel sensor (Hassler, Claim 13),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the position sensor taught in Hassler to the system of Hohlrieder to perform the method of the application, the motivation being to provide a system to measure the travel of the actuating part to gain a better understanding of the pressure in the system.
A modified Hohlrieder teaches after the travel control, checking whether the pressure of the liquid in the receiving space (Hohlrieder, Figure 1 Item 12) of the motor-operated pump unit (Hohlrieder, Figure 1 Item 10) lies within a permissible filling pressure range around the second filling pressure, and if the pressure of the liquid in the receiving space lies outside the permissible filling pressure range around the second filling pressure, adjusting the position of the actuating part (Hohlrieder, Figure 1 Item 14).
Claim(s) 8 - 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohlrieder in view of RE 31,121 hereinafter Reinicke.
In regards to Claim 8: Hohlrieder teaches all of Claim , a manual valve to regulate the flow of the pressurized fluid (Hohlrieder, Figure 1 Item 25), but does not teach where the manual operating unit further comprises a manually openable shut-off valve which is arranged between two sections of the second connecting line, wherein the two sections of the second connecting line are connected to one another in a liquid-conducting manner in an open position of the shut-off valve and the liquid-conducting connection between the two sections of the second connecting line is interrupted in a closed position of the shut-off valve.
Reinicke teaches where the manual operating unit further comprises a manually openable shut-off valve which is arranged between two sections of the second connecting line, wherein the two sections of the second connecting line are connected to one another in a liquid-conducting manner in an open position of the shut-off valve and the liquid-conducting connection between the two sections of the second connecting line is interrupted in a closed position of the shut-off valve (Reinicke, Column 3 Lines 24 -34) (Reinicke, Figure 3 Item 70).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the valve element as taught in Reinicke with the medical device of Hohlrieder, the motivation being to provide allow more or less fluid to be added to the device to adjust the pressure easily without allowing fluid to leak.
In regards to Claim 9: A modified Hohlrieder teaches all of Claim 1, and where the shut-off valve has a return spring which acts on a closure member of the shut off valve and presses the closure member against a sealing seat of the shut-off valve in the closed position. (Reinicke, Column 1 Line 50 – Column 2 Line 2) (Reinicke, Figure 3 Item 71).
In regards to Claim 10: Hohlrieder teaches the device as claimed in claim 8, wherein the flexible pump body has a pump chamber for receiving liquid (Hohlrieder, Figure 1 Item 25) which is supplied to the pump body via the second connecting line, the pump chamber is delimited by two mutually opposite side walls of the pump body, and the side walls are movable into contact so as to reduce a volume of the pump chamber (Hohlrieder, Figure 1 Item 11 & 14).
In regards to Claim 11: Hohlrieder teaches the device as claimed in claim 10, wherein at least one of the opposite side walls has a plurality of raised portions on a side situated in an interior of the pump chamber (Hohlrieder, figure 1 Item 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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/N.R.D./Patent Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791