Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The preliminary amendments filed 08 November 2024 have been entered.
Specification
The disclosure is objected to because of the following informalities: in paragraph 0035, “preasure” should be “pressure”.
Appropriate correction is required.
Claim Objections
Claims 13, 15, 24, and 26 objected to because of the following informalities:
Claim 13, “pressures sensor” should be “pressure sensor”.
Claim 15 is currently recited as depending from claim 13; however, the claim recites “the MEM sensor” in an apparent reference to the microelectromechanical sensor introduced in claim 14. It is suggested that the claim be amended to depend from claim 14. It is additionally suggested that claim 14 be amended to recite “microelectromechanical (MEM) sensor” for clarity prior to the use of “MEM sensor” in claim 15.
Claim 24, “one more position sensors” should be “one or more position sensors”.
Claim 26, “the position sensors” should be “the one or more position sensors”.
Appropriate correction is required.
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 7-22 are 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.
Claim 7 recites the limitation “at least one sensor configured to provide real-time data corresponding to an anatomical state of a subject selected from the group consisting of position, movement, pressure, and flow, for determining a position of the subject's bladder and urethra relative to the subject's pubic bone, coccyx or vagina”. The specification appears to only disclose determining position via a position sensor, such that the claim is inconsistent with the specification (see paragraph 0023-0027 of the instant specification which appear to disclose the combination of position sensors with other sensor types for this purpose but do not disclose the use of only pressure or flow sensors for determining a position). Per MPEP 2173.03: A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970).
Claim 9 recites “at least one sensor configured to provide real-time data of sphincter pressure”. It is not clear if “at least one sensor” is intended to further clarify the at least one sensor of claim 7 or if it is intended to recite an additional sensor which is provided in the device. The limitation is currently interpreted as referring to the at least one sensor as introduced in claim 7.
Claim 16 recites “wherein the device comprises a plurality of position sensors”. It is not clear if the limitation is intended to refer to the at least one sensor of the device comprising a plurality of position sensors or if it refers to the device including an additional plurality of position sensors separate from the at least one sensor. The limitation is currently interpreted as referring to the at least one sensor of the device comprising a plurality of position sensors.
Claim 17 recites “wherein the device comprises a plurality of pressure sensors”. It is not clear if the limitation is intended to refer to the at least one sensor of the device comprising a plurality of pressure sensors or if it refers to the device including an additional plurality of pressure sensors separate from the at least one sensor. The limitation is currently interpreted as referring to the at least one sensor of the device comprising a plurality of pressure sensors.
Claim 19 recite the limitation “the bladder sphincter” in line 1-2 of the claim. There is insufficient antecedent basis for this limitation of the claim.
Claims 8-22 are additionally rejected under 35 U.S.C. 112 as indefinite due to their dependence on claim 7, which has been rejected as indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 7-10, 13, and 17-21 is/are rejected under pre-AIA 35 U.S.C. 102(a) and (b) as being anticipated by Mosel (US 20020111586).
Regarding claim 7, Mosel teaches a multiple sensor-enabled device (Paragraph 0016---0017--pressure-sensing catheter…plurality of urethral pressure sensors may be distributed axially…; paragraph 0101-0104—axial position sensors…; pressure measurement system 12 including pressure measurement catheter 18) comprising at least one sensor configured to provide real-time data (Paragraph 0012, 0014, 0022, 0059, 0065, 0072-0074, 0077, 0089-0091, 0098—pressure sensors…a pressuregram which is shown on a display in real time…; paragraph 0101-0104-- axial position sensors…) corresponding to an anatomical state (paragraph 0007-0014, 0067-0070-- diagnosing and/or treating urinary incontinence. The invention provides pressure-sensing catheter systems which can accurately and reliably monitor both a vesicle pressure and a maximum urethral pressure of a patient during an abdominal pressure pulse so as to determine relationships between these pressures…) of a patient selected from the group consisting of position, movement, pressure, and flow (paragraph 0077-- the pressure sensor can be accurately positioned at target location 30 by moving the catheter axially while viewing a display indicating the pressure at the urethral sensor in real time; paragraph 0101-0104-- pressure profile systems 250 provide axial pressure sensor position measurements in correlation with pressure measurements from the urethral pressure sensor. These associated position and pressure measurements allow an accurate pressure plot of pressures along the length of the urethra to be generated…), for determining a position of the patient's bladder and urethra relative to the patient's pubic bone, coccyx or vagina (Paragraph 0067-0070, 0108-0119-- In women with urinary stress incontinence due to bladder neck hypermobility, the bladder has typically dropped between about 1.0 cm and 1.5 cm (or more) below its nominal position…the treatment of the present invention may be directed at a variety of tissue structures defining the pelvic floor and/or diaphragm…Leakage may result in part because the endopelvic fascia allows the bladder to drop below its initial position…; Figs. 2 and 24A-C showing position of the bladder and urethra relative to the rest of the anatomy).
It is noted that as Mosel discloses pressure sensors for measuring pressure and position sensors for determining the position of each pressure measurement and that the pressure measurements at each position relate to the positioning of the patient’s bladder and urethra relative to the patient's pubic bone, coccyx or vagina, Mosel may be seen to disclose determining a position of the subject's bladder and urethra relative to the subject's pubic bone, coccyx or vagina.
Regarding claim 8, Mosel teaches the device of claim 7. Mosel additionally teaches wherein the device comprises a transmitter for transmitting the real-time data to a graphical user interface (Paragraph 0012, 0014, 0022, 0059, 0072, 0077— A urethral sensor coupler 38 and a vesicular sensor coupler 40 detachably couple the pressure sensors to processor 14, using fluid, optical, or electrical signals to transmits pressure information to the processor as appropriate for the sensor structures…a pressuregram which is shown on a display in real time…).
Regarding claim 9, Mosel teaches the device of claim 7. Mosel additionally teaches wherein the device comprises at least one sensor configured to provide real-time data of sphincter pressure exerted by the patient's bladder (Paragraph 0067-0070, 0077-0078, 0089-0092, 0108-0116, 0119--Measuring the patient's vesicle and urethral pressures with a pressure sensing catheter…).
Regarding claim 10, Mosel teaches the device of claim 7. Mosel additionally teaches wherein said device is a catheter (catheter 18).
Regarding claim 13, Mosel teaches the device of claim 7. Mosel additionally teaches wherein the at least one sensor is a position or pressures sensor (Paragraph 0012, 0014, 0022, 0059, 0065, 0072-0074, 0077, 0089-0091, 0098—pressure sensors…a pressuregram which is shown on a display in real time…; paragraph 0101-0104-- axial position sensors…).
Regarding claim 17, Mosel teaches the device of claim 13. Mosel additionally teaches wherein the device comprises a plurality of pressure sensors positioned along a wall of the device (Pressure sensors 20 and 22, Fig. 4; alternatively, sensors 20, 22a, 22b in Fig. 5; alternatively, pressure sensors 132, 134, in Fig. 10; Paragraph 0072).
Regarding claim 18, Mosel teaches the device of claim 7. Mosel additionally teaches a method for diagnosing or treating urinary incontinence in a patient in need thereof (paragraph 0106-0116--a method 230 for diagnosing and treating a patient using the diagnostic systems described above…) comprising providing the device of claim 7 to the patient and determining an anatomical state of the patient capable of relieving the incontinence (Paragraph 0067-0070, 0106-0116, 0119-0120-- the treatment of the present invention may be directed at a variety of tissue structures defining the pelvic floor and/or diaphragm…By treating the endopelvic fascia to increase its stiffness, the decent time of the pelvic viscera during a cough will be much shorter than an untreated, highly elastic tissue…processor 320 can tailor the treatment for a specific patient's diagnosis, for example, by varying the area of and energy delivered to target region 332 so as to selectively shrink and/or stiffen the endopelvic fascia layer sufficiently to maintain the urethral pressure above the vesicular pressure throughout a pressure pulse; Figs. 2 and 24A-C showing position of the bladder and urethra relative to the rest of the anatomy…).
Regarding claim 19, Mosel teaches the method of claim 18. Mosel additionally teaches wherein the anatomical state is a muscular function of the bladder sphincter (Paragraph 0067-0070, 0106-0120-- urethrovaginal sphincter…When pressure pulse P first begins to act on urethra U, the bladder, bladder neck, and urethra are disposed at initial position 330. As endopelvic fascia stretches significantly under the effects of pressure pulse P, there is a significant time delay between initiation of the pressure pulse and transmission of a closing force against urethra U. For example, urethra U may be closed by transmission of pressure pulse P between one-tenth and one-half second after pulse is imposed on the bladder. Hence, leakage would occur during this time delay…). As Mosel discloses determining an anatomical state of a pressure of a bladder being greater than a pressure of a urethra causing leakage through a urethrovaginal sphincter, it may be seen to disclose wherein the anatomical state is a muscular function of the bladder sphincter.
Regarding claim 20, Mosel teaches the method of claim 18. Mosel additionally teaches wherein the anatomical state is a relative position of a bladder neck and urethra (Paragraph 0067-0070, 0108-0119-- In women with urinary stress incontinence due to bladder neck hypermobility, the bladder has typically dropped between about 1.0 cm and 1.5 cm (or more) below its nominal position…the treatment of the present invention may be directed at a variety of tissue structures defining the pelvic floor and/or diaphragm…Leakage may result in part because the endopelvic fascia allows the bladder to drop below its initial position…; Figs. 2 and 24A-C showing position of the bladder and urethra relative to the rest of the anatomy).
Regarding claim 21, Mosel teaches the method of claim 18. Mosel additionally teaches further comprising manipulating the subject by repositioning the subject's bladder neck and urethra relative to the subject's pubic bone, coccyx or vagina to an optimal anatomical position and sphincter pressure to relieve the incontinence (Paragraph 0067-0070, 0106-0116, 0119-0120-- the treatment of the present invention may be directed at a variety of tissue structures defining the pelvic floor and/or diaphragm…By treating the endopelvic fascia to increase its stiffness, the decent time of the pelvic viscera during a cough will be much shorter than an untreated, highly elastic tissue…processor 320 can tailor the treatment for a specific patient's diagnosis, for example, by varying the area of and energy delivered to target region 332 so as to selectively shrink and/or stiffen the endopelvic fascia layer sufficiently to maintain the urethral pressure above the vesicular pressure throughout a pressure pulse; Figs. 2 and 24A-C showing position of the bladder and urethra relative to the rest of the anatomy).
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.
Claim 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mosel in view of Addington (US 20070255090).
Regarding claim 11, Mosel teaches the device of claim 10. However, Mosel does not teach wherein said catheter is a Foley catheter.
Addington, in the same field of endeavor of a pressure sensing catheter for detecting urinary incontinence, teaches wherein said catheter is a Foley catheter (paragraph 0027). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the catheter of Mosel as a Foley catheter, as taught by Addington, to provide continuous drainage of the bladder during incontinence testing which would improve the device by allowing for easier observation of urinary leakage.
Claim 12 and 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mosel in view of Churchill (US 6001060 A).
Regarding claim 12, Mosel teaches the device of claim 7. However, Mosel does not teach a video capture and/or an illumination source.
Churchill, in the same field of endeavor of a system for monitoring the bladder function of a patient using a pressure-sensing catheter, teaches a video capture and/or an illumination source (col 2, In 4-9, col 3 ln 65-67—video urodynamics diagnostic testing). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the catheter of Mosel with video imaging, as taught by Churchill, to provide video urodynamics data in order to predictably improve the device by allowing for visualization of user anatomy in combination with measured parameters for more robust understanding.
Regarding claim 22, Mosel teaches the method of claim 18. However, Mosel does not teach a video capture and/or an illumination source.
Churchill, in the same field of endeavor of a system for monitoring the bladder function of a patient using a pressure-sensing catheter, teaches a video capture and/or an illumination source (col 2, In 4-9, col 3 ln 65-67—video urodynamics diagnostic testing). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the catheter of Mosel with video imaging, as taught by Churchill, to provide video urodynamics data in order to predictably improve the device by allowing for visualization of user anatomy in combination with measured parameters for more robust understanding.
Claim 14-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mosel in view of Dala-Krishna (US 20080146941 A1).
Regarding claim 14, Mosel teaches the device of claim 13. However, Mosel does not explicitly disclose wherein the position sensor is a microelectromechanical sensor.
Dala-Krishna, in analogous art of a multi-sensor enabled catheter device having one or more sensors for tracking position (Abstract, paragraph 0010-0011, 0028, 0034, 0043-0049-- an apparatus and methods for tracking movement of one or more points of a catheter by using accelerometers deployed at one or more points within the body of the catheter, including parts of the catheter deployed within the body as well as parts of the catheter deployed outside the body. The relative position of the imaging probe is then tracked by constantly monitoring the acceleration of these sensors as a function of time and using this data to calculate displacement from a baseline position), discloses the position sensor is a microelectromechanical sensor (Paragraph 0050-- Examples of suitable accelerometer for use in one or more of the positions on the catheter include micro-electromechanical sensor (MEMS) accelerometers).
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the catheter of Mosel with the microelectromechanical sensors for sensing position of Dala-Krishna as Dala-Krishna discloses that such sensors are known in the art and the incorporation of such sensors would predictably improve the device by allowing for the determination of both linear and rotational position of the device for determining more accurate anatomical positions.
Regarding claim 15, Mosel teaches the device of claim 13. However, Mosel does not explicitly disclose wherein the MEM sensor is an accelerometer.
Dala-Krishna, in analogous art of a multi-sensor enabled catheter device having one or more sensors for tracking position (Abstract, paragraph 0010-0011, 0028, 0034, 0043-0049-- an apparatus and methods for tracking movement of one or more points of a catheter by using accelerometers deployed at one or more points within the body of the catheter, including parts of the catheter deployed within the body as well as parts of the catheter deployed outside the body. The relative position of the imaging probe is then tracked by constantly monitoring the acceleration of these sensors as a function of time and using this data to calculate displacement from a baseline position), discloses wherein the MEM sensor is an accelerometer (Paragraph 0050-- Examples of suitable accelerometer for use in one or more of the positions on the catheter include micro-electromechanical sensor (MEMS) accelerometers).
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the catheter of Mosel with the MEM accelerometers for sensing position of Dala-Krishna as Dala-Krishna discloses that such sensors are known in the art and the incorporation of such sensors would predictably improve the device by allowing for the determination of both linear and rotational position of the device for determining more accurate anatomical positions.
Regarding claim 16, Mosel teaches the device of claim 13. However, Mosel does not explicitly disclose wherein the device comprises a plurality of position sensors positioned along a length of the device.
Dala-Krishna, in analogous art of a multi-sensor enabled catheter device having one or more sensors for tracking position (Abstract, paragraph 0010-0011, 0028, 0034, 0043-0049-- an apparatus and methods for tracking movement of one or more points of a catheter by using accelerometers deployed at one or more points within the body of the catheter, including parts of the catheter deployed within the body as well as parts of the catheter deployed outside the body. The relative position of the imaging probe is then tracked by constantly monitoring the acceleration of these sensors as a function of time and using this data to calculate displacement from a baseline position), discloses wherein the device comprises a plurality of position sensors positioned along a length of the device (paragraph 0028, 0034, 0043-0049, 0071-0073-- the sensors may comprise one or more accelerometers… By including three or more accelerometers positioned about the catheter so they sense accelerations along three different axes… a number of accelerometers may need to be included and data from each integrated with others to accurately track the position and orientation of the array).
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the catheter of Mosel with the plurality of accelerometers for sensing position of Dala-Krishna as Dala-Krishna discloses that such sensors are known in the art and the incorporation of such sensors would predictably improve the device by allowing for the determination of both linear and rotational position of the device for determining more accurate anatomical positions.
Claim 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tippey (US 5562717 A) in view of Damaser (WO 2005115245 A1).
Regarding claim 23, Tippey teaches a method for diagnosing or treating fecal incontinence in a subject in need thereof (col 1, In 7-10—treatment for urinary and faecal incontinence) comprising:
inserting an elongated device comprising one or more pressure sensors into the rectum of a subject (col 4, In 30-32 and 62-65-col 5 ln 2— comprising inserting an elongated device comprising one or more pressure sensors into the rectum of a subject..),
and determining an anatomical state of the subject capable of relieving the incontinence (Col 5, ln 24-Col 6 ln 8-- Treatment parameters may be down loaded from a PC into an integral memory using specially prepared software which initiates the specific parameters according to a patient's case history and symptoms… Pulsed currents may also be applied via a combination of the tampon and the surface electrodes to direct the current to specific muscles/nerve groups). As Tippey discloses the determining of which muscle/nerve groups should be provided with pulsed currents for strengthening to relieve incontinence, it may be seen to disclose determining an anatomical state of the subject capable of relieving the incontinence.
However, Tippey does not disclose inserting an apparatus comprising one more position sensors into the vagina of the subject.
Damaser, in the same field of endeavor of a system and method for monitoring incontinence, discloses a system including an intravaginal or intrarectal probe comprising one or more position sensors and one or more pressure sensors (Col 5, ln 7-9--The system of the invention may further comprise an intravaginal or intrarectal probe that measures abdominal pressure and temperature as well as patient position and acceleration.).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the system of Tippey, including an elongated device including pressure sensors configured to be inserted into the rectum of a subject, to additionally include an intravaginal probe equipped with sensors as disclosed by Damaser in order to predictably improve the method by providing additional data relating to the anatomical positions and pressures of the patient which would provide a more full picture of the patient’s possible dysfunction for diagnosis or treatment purposes.
Claim 24 and 27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tippey in view of Damaser, further in view of Mosel.
Regarding claim 24, Tippey teaches a system for treating urinary and faecal incontinence (col 1, In 7-10—treatment for urinary and faecal incontinence) comprising an elongated intrarectal device comprising one or more pressure sensors comprising inserting an elongated device comprising one or more pressure sensors into the rectum of a subject (col 4, In 30-32 and 62-65-col 5 ln 2— comprising inserting an elongated device comprising one or more pressure sensors into the rectum of a subject..),
and determining an anatomical state of the subject capable of relieving the incontinence (Col 5, ln 24-Col 6 ln 8-- Treatment parameters may be down loaded from a PC into an integral memory using specially prepared software which initiates the specific parameters according to a patient's case history and symptoms… Pulsed currents may also be applied via a combination of the tampon and the surface electrodes to direct the current to specific muscles/nerve groups).
However, Tippey does not disclose an intravaginal device comprising one more position sensors.
Damaser, in the same field of endeavor of a system and method for monitoring incontinence, discloses a system including an intravaginal device comprising one more position sensors (Col 5, ln 7-9--The system of the invention may further comprise an intravaginal or intrarectal probe that measures abdominal pressure and temperature as well as patient position and acceleration.) in conjunction with a sensor enabled intravesicular device (a conductance probe is mounted on an intravesicular device that is delivered deployed in the bladder)..
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the system of Tippey, including an elongated device including pressure sensors configured to be inserted into the rectum of a subject, to additionally include an intravaginal probe and intravesicular device equipped with sensors as disclosed by Damaser in order to predictably improve the system by providing additional data relating to the anatomical positions and pressures of the patient which would provide a more full picture of the patient’s possible dysfunction for diagnosis or treatment purposes.
However, the combination of Tippey and Damaser does not disclose a multi-sensor enabled catheter.
Mosel, in the same field of endeavor of a system for monitoring and treating incontinence, teaches a multiple sensor-enabled device (Paragraph 0016---0017--pressure-sensing catheter…plurality of urethral pressure sensors may be distributed axially…; paragraph 0101-0104—axial position sensors…; pressure measurement system 12 including pressure measurement catheter 18) comprising at least one sensor configured to provide real-time data (Paragraph 0012, 0014, 0022, 0059, 0065, 0072-0074, 0077, 0089-0091, 0098—pressure sensors…a pressuregram which is shown on a display in real time…; paragraph 0101-0104-- axial position sensors…).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the system of Tippey and Damaser, including an elongated device including pressure sensors configured to be inserted into the rectum of a subject and an intravaginal device comprising one or more position sensors, to additionally include a multi-sensor enabled catheter as disclosed by Mosel in order to predictably improve the system by providing additional data relating to the anatomical positions and pressures of the patient which would provide a more full picture of the patient’s possible dysfunction for diagnosis or treatment purposes.
Regarding claim 27, the combination of Tippey, Damaser, and Mosel teaches the system of claim 24. Tippey additionally teaches a method treating fecal incontinence (col 1, In 7-10—treatment for urinary and faecal incontinence) comprising: providing a system (see above) to a subject and determining an anatomical state of the subject capable of relieving the incontinence (Col 5, ln 24-Col 6 ln 8-- Treatment parameters may be down loaded from a PC into an integral memory using specially prepared software which initiates the specific parameters according to a patient's case history and symptoms… Pulsed currents may also be applied via a combination of the tampon and the surface electrodes to direct the current to specific muscles/nerve groups).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify a method of Tippey to utilize a device including the additional sensing elements of Damaser and Mosel as described above in this action, in order to predictably improve the method by providing additional data relating to the anatomical positions and pressures of the patient which would provide a more full picture of the patient’s possible dysfunction for diagnosis or treatment purposes.
Claim 25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tippey in view of Damaser, further in view of Mosel, further in view of Addington.
Regarding claim 25, the combination of Tippey, Damaser, and Mosel teaches the system of claim 24. However, Mosel does not teach wherein said catheter is a Foley catheter. Addington, in the same field of endeavor of a pressure sensing catheter for detecting urinary incontinence, teaches wherein said catheter is a Foley catheter (paragraph 0027). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the catheter of Mosel within the combined system as a Foley catheter, as taught by Addington, to provide continuous drainage of the bladder during incontinence testing which would improve the device by allowing for easier observation of urinary leakage.
Claim 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tippey in view of Damaser, further in view of Mosel, further in view of Dala-Krishna.
Regarding claim 26, the combination of Tippey, Damaser, and Mosel teaches the system of claim 24. However, Damaser does not disclose wherein the position sensors are MEM sensors.
Dala-Krishna, in analogous art of a multi-sensor enabled catheter device having one or more sensors for tracking position (Abstract, paragraph 0010-0011, 0028, 0034, 0043-0049-- an apparatus and methods for tracking movement of one or more points of a catheter by using accelerometers deployed at one or more points within the body of the catheter, including parts of the catheter deployed within the body as well as parts of the catheter deployed outside the body. The relative position of the imaging probe is then tracked by constantly monitoring the acceleration of these sensors as a function of time and using this data to calculate displacement from a baseline position), discloses the position sensor is a microelectromechanical sensor (Paragraph 0050-- Examples of suitable accelerometer for use in one or more of the positions on the catheter include micro-electromechanical sensor (MEMS) accelerometers).
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the intravaginal device of Damaser with the microelectromechanical sensors for sensing position of Dala-Krishna as Dala-Krishna discloses that such sensors are known in the art and the incorporation of such sensors would predictably improve the device by allowing for the determination of both linear and rotational position of the device for determining more accurate anatomical positions.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791
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