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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/01/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 04/01/2026.
Status of the claims:
Claims 1 – 14 and 21 – 28 are pending in the application.
Claim 1 is amended.
Claims 27 and 28 are new.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “a baby” (second instance) in line 12-13, although the line is understood by the Examiner to mean “the baby” as the “baby” was previously defined, the Examiner suggests the line be amended to read “the baby” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3 – 6, 9, 12, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kring et al (US 2003/0087734 A1) (previously cited) and in view of Mashimo et al (US 2010/0113939 A1) (previously cited).
Regarding claims 1, 3 – 6, and 12, Kring discloses a system (vaginal-pelvic muscle exerciser and birthing trainer) for preparing the a genital tract of a woman before a childbirth (abstract, paragraphs [0006], [0024 – 0026], [0029], [0060], and Figs. 1 – 7), the system comprising:
an inflatable body (bulb 20) intended to be placed in the genital tract of the woman (paragraphs [0031], [0033 – 0042], and [0070]), the inflatable body comprising a wall (wall of bulb 20) including a first open end (proximal end – end closest to handle 53 – shown in Fig. 1B) intended to allow air to enter the inflatable body or an air to leave the inflatable body and a second closed end (distal end 24) opposite the first end (Figs. 1A/1B) [claim 12] the second closed end comprising a bulge (rounded distal end of the bulb 20) (Figs. 1A/1B) (Examiner’s note: the term “bulge” is defined as a rounded swelling that distorts a flat surface; with that said, the distal end is a rounded swelling that distorts the flat surface of the balloon. It is also noted that Applicant’s bulge in the inflated state is the same as the “bulge” of Kring in the inflated state),
wherein the inflatable body (bulb 20) in an inflated state is configured to simulate the head of a baby and allows for simulation of the passage of the head of a baby along the genital tract (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning as claimed. With that said, because the bulb 20 (i.e., the inflatable body) is inserted into the vaginal canal and is expandable to an inflated state to stretch the muscles and the canal, as taught in the abstract and paragraph [0024], it can be said that the bulb 20 (i.e., the inflatable body) is capable of simulating a head of a baby and allow for simulation of the passage of the head of the baby along the genital tract);
[claim 4] the inflatable body having a substantially circular cross-section (Fig. 2) (Examiner’s note: the term “substantially” is a broad term, and does not require the cross-section to be fully circular, with that said the cross-section as shown in Fig. 2 completes a circle and is curved in a circular-ish shape; therefore, the cross-section shown in Figs. 2 and 3 is said to be “substantially” circular as claimed);
[claims 5 and 6] the inflatable body comprising a central support (inserter 100) that is a semi-rigid rod extending into the inflatable body (paragraph [0066] and Figs. 1A/1B);
an inflation device (inflation component 120) of the inflatable body (bulb 20) fluidly connected to the first open end of the inflatable body (bulb 20) by a conduit (tubing 80) (paragraphs [0060], [0066], [0069], and Figs. 1A/1B, 9, 10, and 11).
However, Kring is silent regarding (i) [claims 1, 3, 4, 5, and 6] a measuring device, integrated into the inflatable body on the free end of the central support, comprising at least one distance sensor configured to measure a dimension, corresponding to / measuring a diameter of a cross-section, of the inflatable body and measure a distance between the central support and a point located on an inner face of the wall of the inflatable body and (ii) [claim 1] a control device configured to collect measurement data of the dimension measured by the measuring device.
As to the above, Mashimo, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely a means for sensing the dimensions of an inflated balloon, teaches a smart balloon comprising an inflatable body (inflatable membrane 32) with a support rod (catheter 30) extending there through with a measuring device (impedance planimeters 38A) disposed thereon, wherein the measuring device (impedance planimeters 38A) comprises at least one distance sensor (impedance planimeters 38A) configured to measure a distance between the central support (catheter 30) to an inner face of the wall of the inflatable body (inflatable member 32) (abstract, paragraphs [0023], [0026], and [0042]) (Examiner’s note: the impedance planimeters measure the radial distance from the catheter to the wall of the balloon – paragraph [0026]; the measured distance corresponds to the diameter (i.e., a dimension) and cross-section of the inflatable member), and a control device (computer 14) configured to collect measurement data of the dimension (diameter / cross-section) measured by the measuring device (impedance planimeters 38A) (paragraphs [0024] and [0026]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Kring to incorporate a distance measuring sensor on the central support, based on the teachings of Mashimo, for the purpose of providing in-real time data feedback to the user of the balloon, thereby helping to guide the user in the appropriate management of the constricted area via the balloons dilation, rate of expansion, and effectiveness of dilation (paragraph [0031] – Mashimo).
Additionally, it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of positions for the distance measuring sensor to be placed on the central support (i.e., inserter 100) of Kring, the distance measuring sensor can be placed: at the distal end (as claimed), at the proximal end, or some location in between the distal and proximal ends; and the Examiner contends it would have been obvious to one of ordinary skill in the art to have the distance measuring sensor to be placed at the distal end (i.e., the free end) of the central support (i.e., the inserter 100) of Kring, as there are a limited number of possible locations for the sensor, and having the sensor positioned at the distal end (i.e., the free end) would have yielded, with a reasonable expectation of success, a means to calculate the diameter of the inflatable body (i.e., bulb 20) of Kring; additionally, one of ordinary skill in the art would have a reasonable expectation of success in modify the system to have the sensor be placed at the distal end.
Regarding claim 9, as discussed above, it would have been obvious to modify the system of Kring to include a measuring device on the central support and a computer to display the data received from the measuring device based on the teachings of Mashimo. Additionally, Kring further discloses a first part (bulb 20 and inserter 100 of Kring) comprising the inflatable body (bulb 20 of Kring) intended to be placed in the genital tract (paragraph [0070] of Kring) and a second part (inflation device 120 of Kring and computer 14 of Mashimo) intended to remain outside the genital tract, the second part comprising the inflation device (inflation device 120 of Kring), the control device (computer 14 of Mashimo) and at least one computer (computer 14 of Mashimo) configured to calculate a quantity of air entering the inflatable body and/or a quantity of air leaving the inflatable body (paragraph [0024]) (Examiner’s note: Applicant’s disclosure Fig. 5 shows the computer is a part of the controller connected to the pressure sensor; therefore, the Examiner is also interpreting the claim to mean that the computer is a part of the controller that is connected to a pressure sensor).
However, the current combination is silent regarding a measuring device that remains outside of the genital track, wherein the measuring device comprising at least one pressure sensor.
As to the above, Mashimo further teaches a pumping system 22 comprising pressure and flow sensors (paragraph [0024]) for the purpose of providing feedback used in determining the rate of inflation / deflation of the balloon membrane and allowing the user to implement a step-wise / gradual dilation of the balloon (paragraphs [0009 – 0010], [0024], and [0031]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Kring in view of Mashimo to further include the pumping system with the pressure and flow sensors of Mashimo, for the purpose of providing feedback used in determining the rate of inflation / deflation of the balloon membrane and allowing the user to implement a step-wise / gradual dilation of the balloon (paragraphs [0009 – 0010], [0024], and [0031] – Mashimo). It should be understood that the combination above is such that the measuring device comprises the pressure and flow sensors, which are located outside of the body and transmit data to the computer.
Regarding claim 23, as discussed above, it would have been obvious to modify the system of Kring to include a measuring device on the central support and a computer to display the data received from the measuring device based on the teachings of Mashimo. Additionally, Kring discloses wherein the bulge allows a lubricated element to be attached to the inflatable body to allow facilitating an insertion of the inflatable body into the genital tract of the woman (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation and requires only that the structure of the prior art be capable of functioning as claimed. With that said there is nothing that would prohibit the “bulge” of the of Kring from allowing a lubricated element to be attached thereto; therefore, the system of Kring is configured as claimed).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kring et al (US 2003/0087734 A1) (previously cited) in view of Mashimo et al (US 2010/0113939 A1) (previously cited), as applied to claim 1, and further in view of Gilbert (US 2017/0119950 A1) (previously cited).
Regarding claim 2, as discussed above, it would have been obvious to modify the system of Kring to include a measuring device on the central support and a computer to display the data received from the measuring device based on the teachings of Mashimo.
However, the combination of Kring and Mashimo is silent regarding (i) wherein the control device is arranged to transmit the measurement data from the measuring device to an interface device configured to receive and display the measurement data by a wireless communication link.
As to the above, Gilbert teaches a medical device (catheter system 100) comprising a balloon (occlusion component 103) (paragraph [0062]) and a measuring device (pressure sensor) for measuring the pressure of the vasculature, and computer for transmitting / interfacing via a wireless connection with any type of network capable of communication and performing the operations (i.e., an interface device) (paragraph [0130]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the controller / computer of Kring in view of Mashimo to be arranged to transmit the measurement data from the measuring device to an interface via a wireless communication link for the purpose of being able to use a mobile device for analyzing the data instead of having to be in a fixed location.
Claims 7 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kring et al (US 2003/0087734 A1) (previously cited) in view of Mashimo et al (US 2010/0113939 A1) (previously cited), as applied to claim 1, and further in view of Dupont et al (US 2021/0236773 A1).
Regarding claims 7 and 26, as discussed above, it would have been obvious to modify the system of Kring to include a measuring device on the central support and a computer to display the data received from the measuring device based on the teachings of Mashimo.
However, the combination of Kring and Mashimo is silent regarding (i) wherein the at least one distance sensor is an infrared sensor.
As to the above, Dupont teaches a robotic system comprising a distance sensor 420 to constantly measure the distance between the sensor and nearby medical instruments (which equates to the inner diameter of the bulb of Kring) via an infrared sensor (which equates to the impedance planimeters 38A of Mashimo in the bulb of Kring) (abstract, paragraphs [0130], [0132], and [0133]).
It should be understood that Kring in view of Mashimo and Dupont are known references in the art that teach a means of determining a distance between two objects within a medical system (abstract, paragraphs [0023], [0026], and [0042] – Mashimo ; abstract, paragraphs [0130], [0132], and [0133] – Dupont); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one distance sensor for another (i.e., the impedance planimeters for the ultrasonic transducer sensor), and the results of the substitution would have been predictable and resulted in the modified combination of Kring and Mashimo being able to function as intended to properly measure the inner diameter of the bulb (balloon) of Kring. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Claims 8 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Kring et al (US 2003/0087734 A1) (previously cited) in view of Mashimo et al (US 2010/0113939 A1) (previously cited), as applied to claims 1 and 6, respectively, and further in view of Atad et al (US 2020/0383703 A1) (previously cited) and Kinoshita et al (US 2012/0253114 A1) (previously cited).
Regarding claim 8, as discussed above, it would have been obvious to modify the system of Kring to include a measuring device on the central support and a computer to display the data received from the measuring device based on the teachings of Mashimo.
However, the combination of Kring and Mashimo is silent regarding (i) the at least one distance sensor is a shooting device and (ii) in that the inflatable body comprises at least one pattern or a rib arranged on an inner face of the wall of the inflatable body.
As to (i), Atad teaches, in the same field of endeavor, a system (inflatable system 50) comprising an inflatable body (a vaginal balloon; which equates to the bulb 20 of Kring) for cervical dilation with a distance senser / shooting device (imaging sensor 101; which equates to the impedance planimeters 38A of Mashimo) (Examiner’s note: Applicant’s disclosure defines a “shooting device” as a camera; therefore the Examiner is examining the term “shooting device” to mean a camera) placed therein for measuring the cervical neck opening (i.e., the diameter / distance of the opening; which equates to measuring the diameter of the bulb 20 of Kring via the impedance planimeters 38A of Mashimo) (abstract and paragraphs [0014] and [0051]).
It should be understood that Kring in view of Mashimo and Atad are known references in the art that teach a means of determining an inner diameter of structure that is a part of a medical system (abstract, paragraphs [0023], [0026], and [0042] – Mashimo ; abstract and paragraphs [0014] and [0051] – Atad); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one distance sensor for another (i.e., the impedance planimeters for the camera), and the results of the substitution would have been predictable and resulted in the modified combination of Kring and Mashimo being able to function as intended to properly measure the inner diameter of the bulb (balloon) of Kring. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
As to (ii), Kinoshita teaches a medical system (sinusitis treatment system) comprising an image sensor (camera 15) and at least one pattern (marker “M” which forms a color / pattern on the elongated body 12), wherein the at least one pattern (marker “M”) is used to indicate the location of a particular section of the inflatable body (the expansion section 13a), and can be used to determine the relative location between the image sensor (camera 15) and the particular section of the inflatable body (the expansion section 13a). Furthermore, Kinoshita teaches that the high brightness of the color of the at least one pattern (marker “M”) gives the user a better means to visual / confirm the image taken by the camera in order to determine the relative distances between the inflatable body (expansion section 13a) and the image sensor (camera 15).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the inner wall of the inflatable body (bulb 20) of Kring in view of Mashimo and Atad with a pattern / color marker, based on the teachings of Kinoshita, for the purpose of enhancing the images taken by the camera sensor so that the change in relative positions between the inner wall of the inflatable body (bulb 20) of Kring can be more easily confirmed by more easily seeing the inner wall of the inflatable body (bulb 20) of Kring via the high brightness of the marker.
Regarding claim 25, as discussed above, it would have been obvious to modify the device of Kring in view of Mashimo with a camera. Additionally, the combination teaches wherein the shooting device makes it possible to know, in real time, a state of the inner face of the wall of the inflatable body, by comparing an image taken at time T 1 with an initial image taken at time TO, it is possible to deduce using an image analysis, an increase in the dimension of the inflatable body (Examiner’s note: it should be understood that the preceding limitation is intended use, which requires only that the structure of the prior art be capable of performing as claimed. With that said, because the camera takes pictures in real time, the camera allows the system to operate as claimed. Therefore, the combination encompasses the claim).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kring et al (US 2003/0087734 A1) (previously cited) in view of Mashimo et al (US 2010/0113939 A1) (previously cited), as applied to claim 9, and further in view of Lin (US 2021/0001022 A1) (previously cited).
Regarding claims 10 and 11, as discussed above, it would have been obvious to modify the system of Kring to include a measuring device on the central support and a computer to display the data received from the measuring device based on the teachings of Mashimo.
However, the combination of Kring and Mashimo is silent regarding (i) wherein the at least one computer is configured to calculate the quantity of air entering the inflatable body using information communicated by [claim 10] a motor and/or [claim 11] a solenoid valve.
As to the above, Lin teaches a medical fluid delivery system with a pump system 89 (which equates to the pumping system 22 of Mashimo) with measuring device (inflow / outflow pressure sensors 91 / 93) comprising a pressure sensor (pressure sensors 91 / 93) and at least one computer (microprocessors) configured to calculate a quantity of air entering or leaving an inflatable body (inflatable chamber 130; which equates to the bulb 20 of Kring) via information communicated by a motor (stepper motor) and/or a solenoid valve (solenoids) (paragraphs [0042 – 0051] and [0055]), wherein the at least one computer (controller 87) is configured to calculate the quantity of air entering the inflatable body using information (data 71,72,73,75) (paragraphs [0042 – 0051]) communicated by the stepper motor and/or solenoid valve (Examiner’s note: the pressure sensors 91 and 93 coupled with the motors and solenoids communicate the data to the controller).
It should be understood that Kring in view of Mashimo and Lin are known references in the art that teach a means of controlling the flow rate and pressure of a system based on information received from a pumping system (abstract, paragraphs [0023], [0026], and [0042] – Mashimo ; abstract and paragraphs [0042 – 0051] – Lin); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted means for controlling the pressure of a system for another, and the results of the substitution would have been predictable and resulted in the modified combination of Kring and Mashimo being able to function as intended to properly control the pressure of the bulb (balloon) of Kring. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kring et al (US 2003/0087734 A1) (previously cited) in view of Mashimo et al (US 2010/0113939 A1) (previously cited), as applied to claim 1, and further in view of Binder, Jr et al (US 2006/0004398 A1) (previously cited).
Regarding claim 13, as discussed above, the combination of Kring and Mashimo teaches the device of claim 1 above. Additionally, Kring discloses a portion of [claim 13] wherein the system further comprises a gripping means (handle 50 / graspable part of the inserter 53) intended for positioning the inflatable body (bulb 20) in the genital track of the women (paragraphs [0036] and [0064]).
However, the combination of Kring and Mashimo is silent regarding (i) wherein the gripping means is semi-rigid.
As to the above, Binder Jr teaches surgical a dilator (which equates to the surgical bulb 20 of Kring, as the bulb 20 dilates the cervical canal) with a gripping means (handle; which equates to the gripping means of Kring) made up of ultra-high molecular weight polyethylene (paragraph [0040]) which is a semi-rigid material.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the gripping means of Kring in view of Mashimo to be made out of ultra-high molecular weight polyethylene (UHMWPE) (i.e., a semi-rigid material) as UHMWPE is a known material known to be used to make up handles of similar medical devices (i.e., dilators), and one of ordinary skill in the art would have a reasonable expectation of success in forming the gripping means of Kring out of UHMWPE without effecting the intended use, thus the modification would result in the gripping means of Kring still being operable for its intended purpose.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kring et al (US 2003/0087734 A1) (previously cited) in view of Mashimo et al (US 2010/0113939 A1) (previously cited) and Binder, Jr et al (US 2006/0004398 A1) (previously cited), as applied to claim 13, and further in view of Lastimado et al (US 11,141,119 B1) (filed on 06/26/2017) (previously cited).
Regarding claim 14, as discussed above, the combination of Kring, Mashimo, and Binder Jr teaches the device of claim 13 above.
However, the combination of Kring, Mashimo, and Binder Jr is silent regarding (i) wherein the handle is a telescopic handle.
As to the above, Lastimado teaches a medical system with an inserter-able distal end (x-ray sensor 100; which is equated to the bulb 20 of Kring which is inserted into the cervical canal) with a telescopic handle (handle assembly 50) wherein the telescoping feature provides the user to select a desired length of the handle (col. 4 lines 6 – 33).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the handle of Kring in view of Mashimo and Binder Jr to be a telescopic handle, based on the teachings of Lastimado, for purpose of accommodating differing needs of multiple users by allowing the user to select the desired length.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kring et al (US 2003/0087734 A1) (previously cited) in view of Mashimo et al (US 2010/0113939 A1) (previously cited), as applied to claim 1, and further in view of Kadamus et al (US 2020/0305972 A1).
Regarding claims 21 and 22, as discussed above, it would have been obvious to modify the system of Kring to include a measuring device on the central support and a computer to display the data received from the measuring device based on the teachings of Mashimo.
However, the combination of Kring and Mashimo is silent regarding (i) [claim 21] wherein the measuring device further comprises a temperature sensor, connected to the conduit of the system and (ii) [claim 22] the measuring device is arranged to determine the dimension of the inflatable body according to a pressure value, a temperature value and a quantity of air in the inflatable body.
As to the above, Kadamus teaches a catheter system (system 100) comprising an inflatable body (expandable assembly 130; which equates to the bulb 20 of Kring) with a measuring device (functional element 109d; which equates to the impedance planimeters 38A of Mashimo) configured to measure the a dimension (inflation diameter) of the inflatable body (expandable assembly 130) wherein the measuring device further comprises a temperature sensor (functional element 109d) wherein the measuring device is arranged to determine the dimension of the inflatable body according to a pressure value, a temperature value and a quantity of air in the inflatable body (paragraphs [0114] and [0202]) (Examiner’s note: as stated in paragraph [0114] the functional element comprises a sensor that produces a signal the correlates to the temperature, pressure, and volume. Therefore, the sensor is a temperature sensor as it signals the temperature of the balloon, and is arranged to determine the expansion (i.e., diameter of the balloon) via the pressure, volume, and temperature. Additionally, it should be understood that because the functional element 109d (i.e., the measuring device) produces a signal that relates to the temperature of the inflation fluid, the volume, and the pressure, the device is arranged such that the dimension (i.e., the diameter) can be determined).
It should be understood that Kring in view of Mashimo and Kadamus are known references in the art that teach a means of determining an expansion diameter of structure that is a part of a medical system (abstract, paragraphs [0023], [0026], and [0042] – Mashimo ; abstract and paragraphs [0114] and [0202] – Kadasmus); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one distance sensor for another (i.e., the impedance planimeters for the functional element of Kadasmus), and the results of the substitution would have been predictable and resulted in the modified combination of Kring and Mashimo being able to function as intended to properly measure the inner diameter of the bulb (balloon) of Kring. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that because the modified device of Kring and Mashimo teaches the measuring device is located on the conduit of the system, the device of Kring in view of Mashimo and Kadamus would also comprise wherein the measuring device is connected to the conduit of the system.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Kring et al (US 2003/0087734 A1) (previously cited) in view of Mashimo et al (US 2010/0113939 A1) (previously cited), Atad et al (US 2020/0383703 A1) (previously cited) and Kinoshita et al (US 2012/0253114 A1) (previously cited), as applied to claim 8, and further in view of Moreschi (US 2008/0004485 A1).
Regarding claim 24, as discussed above, the combination of Kring, Mashimo, Gilbert, Atad, and Kinoshita teaches the device of claim 8.
However, the combination above is silent regarding (i) a plurality of ribs arranged on the inner face of the wall of the inflatable body.
As to the above, Moreschi teaches a catheter system comprising an inflatable body (balloon 119; which equates to the bulb 20 of Kring) comprising a plurality of laterally extending ribs for the purpose of reinforcing the balloon (paragraph [0050] and Fig. 14).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the inflatable body of Kring in view of Mashimo, Gilbert, Atad, and Kinoshita to incorporate a plurality of ribs, based on the teachings of Moreschi, for the purpose of reinforcing the balloon (paragraph [0050] – Moreschi).
Claims 1, 3 – 6, 9, 12, 23, and 27 – 28 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al (US 2009/0111671 A1) and in view of Mashimo et al (US 2010/0113939 A1) (previously cited).
Regarding claims 1, 3 – 6, and 12, Campbell discloses a system (vaginal-pelvic muscle exerciser) for preparing the a genital tract of a woman before a childbirth (abstract, paragraphs [0005], [0026 – 0028], Figs. 1 – 7) (Examiner’s note: strengthening of the muscles of the pelvic diaphragm helps prepare the vaginal canal for childbirth), the system comprising:
an inflatable body (balloon member 116) intended to be placed in the genital tract of the woman (paragraph [0136] and Fig. 8B), the inflatable body comprising a wall (wall of balloon member 116) including a first open end (sealed end 117 – opened such that it allows the passage of tube 111) intended to allow air to enter the inflatable body or an air to leave the inflatable body and a second closed end (tip end 121) opposite the first end (Figs. 7) [claim 12] the second closed end comprising a bulge (tapered tip 122) (paragraph [0135] and Fig. 5),
wherein the inflatable body (balloon member 116) in an inflated state is configured to simulate the head of a baby and allows for simulation of the passage of the head of a baby along the genital tract (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning as claimed. With that said, because the balloon member 116 (i.e., the inflatable body) is inserted into the vaginal canal and is expandable to an inflated state to stretch and strengthen the pelvic diaphragm muscles, as taught in the abstract and paragraph [0028], it can be said that the balloon member 116 (i.e., the inflatable body) is capable of simulating a head of a baby and allow for simulation of the passage of the head of the baby along the genital tract);
an inflation device (syringe 135) of the inflatable body (balloon member 116) fluidly connected to the first open end of the inflatable body (balloon member 116) by a conduit (hose barb 136) (paragraph [0136] and Fig. 8C);
[claim 4] the inflatable body having a substantially circular cross-section (Fig. 6);
[claims 5 and 6] the inflatable body comprising a central support (tube 111) that is a semi-rigid rod extending into the inflatable body (balloon member 116) (paragraph [0134] and Figs. 1-7);
[claim 27] wherein the inflatable body (inflatable balloon 116) is substantially cylindrical between the open first end and the closed second end (paragraph [0159] and Fig. 5);
[claim 28] wherein the inflatable body (inflatable balloon 116) is substantially spherical between the open first end and the closed second end (paragraph [0159]; the device maybe be circular (i.e., spherical)).
However, Campbell is silent regarding (i) [claims 1, 3, 4, 5, and 6] a measuring device, integrated into the inflatable body on the free end of the central support, comprising at least one distance sensor configured to measure a dimension, corresponding to / measuring a diameter of a cross-section, of the inflatable body and measure a distance between the central support and a point located on an inner face of the wall of the inflatable body and (ii) [claim 1] a control device configured to collect measurement data of the dimension measured by the measuring device.
As to the above, Mashimo, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely a means for sensing the dimensions of an inflated balloon, teaches a smart balloon comprising an inflatable body (inflatable membrane 32) with a support rod (catheter 30) extending there through with a measuring device (impedance planimeters 38A) disposed thereon, wherein the measuring device (impedance planimeters 38A) comprises at least one distance sensor (impedance planimeters 38A) configured to measure a distance between the central support (catheter 30) to an inner face of the wall of the inflatable body (inflatable member 32) (abstract, paragraphs [0023], [0026], and [0042]) (Examiner’s note: the impedance planimeters measure the radial distance from the catheter to the wall of the balloon – paragraph [0026]; the measured distance corresponds to the diameter (i.e., a dimension) and cross-section of the inflatable member), and a control device (computer 14) configured to collect measurement data of the dimension (diameter / cross-section) measured by the measuring device (impedance planimeters 38A) (paragraphs [0024] and [0026]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Campbell to incorporate a distance measuring sensor on the central support, based on the teachings of Mashimo, for the purpose of providing in-real time data feedback to the user of the balloon, thereby helping to guide the user in the appropriate management of the constricted area via the balloons dilation, rate of expansion, and effectiveness of dilation (paragraph [0031] – Mashimo).
Additionally, it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of positions for the distance measuring sensor to be placed on the central support (i.e., tubing 111) of Campbell, the distance measuring sensor can be placed: at the distal end (as claimed), at the proximal end, or some location in between the distal and proximal ends; and the Examiner contends it would have been obvious to one of ordinary skill in the art to have the distance measuring sensor to be placed at the distal end (i.e., the free end) of the central support (i.e., the tubing 111) of Campbell, as there are a limited number of possible locations for the sensor, and having the sensor positioned at the distal end (i.e., the free end) would have yielded, with a reasonable expectation of success, a means to calculate the diameter of the inflatable body (i.e., inflatable balloon 116) of Campbell; additionally, one of ordinary skill in the art would have a reasonable expectation of success in modify the system to have the sensor be placed at the distal end and the results would have been predictable.
Regarding claim 9, as discussed above, it would have been obvious to modify the system of Campbell to include a measuring device on the central support and a computer to display the data received from the measuring device based on the teachings of Mashimo. Additionally, Campbell further discloses a first part (inflatable balloon 116 and some of tubing 111 of Campbell) comprising the inflatable body (inflatable balloon 116 of Campbell) intended to be placed in the genital tract (paragraph [0145] of Campbell) and a second part (syringe 135 of Campbell and computer 14 of Mashimo) intended to remain outside the genital tract, the second part comprising the inflation device (syringe 135 of Campbell), the control device (computer 14 of Mashimo) and at least one computer (computer 14 of Mashimo) configured to calculate a quantity of air entering the inflatable body and/or a quantity of air leaving the inflatable body (paragraph [0024]) (Examiner’s note: Applicant’s disclosure Fig. 5 shows the computer is a part of the controller connected to the pressure sensor; therefore, the Examiner is also interpreting the claim to mean that the computer is a part of the controller that is connected to a pressure sensor).
However, the current combination is silent regarding (i) a measuring device that remains outside of the genital track, wherein the measuring device comprising at least one pressure sensor.
As to the above, Mashimo further teaches a pumping system 22 comprising pressure and flow sensors (paragraph [0024]) for the purpose of providing feedback used in determining the rate of inflation / deflation of the balloon membrane and allowing the user to implement a step-wise / gradual dilation of the balloon (paragraphs [0009 – 0010], [0024], and [0031]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Campbell in view of Mashimo to further include the pumping system with the pressure and flow sensors of Mashimo, for the purpose of providing feedback used in determining the rate of inflation / deflation of the balloon membrane and allowing the user to implement a step-wise / gradual dilation of the balloon (paragraphs [0009 – 0010], [0024], and [0031] – Mashimo). It should be understood that the combination above is such that the measuring device comprises the pressure and flow sensors, which are located outside of the body and transmit data to the computer.
Regarding claim 23, as discussed above, it would have been obvious to modify the system of Campbell to include a measuring device on the central support and a computer to display the data received from the measuring device based on the teachings of Mashimo. Additionally, Campbell discloses wherein the bulge allows a lubricated element to be attached to the inflatable body to allow facilitating an insertion of the inflatable body into the genital tract of the woman (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation and requires only that the structure of the prior art be capable of functioning as claimed. With that said there is nothing that would prohibit the “bulge” (i.e., the tip 121) of Campbell from allowing a lubricated element to be attached thereto; therefore, the system of Campbell is configured as claimed).
Response to Arguments
Applicant's arguments filed 03/11/2026 have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s arguments directed to the newly added limitations to claim 1. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. With that said, the inflatable devices of both Kring and Campbell are capable of simulating the head of a baby and allow for the simulation of the passage of the head of a baby along the genital track. Therefore, Applicant’s arguments are not persuasive.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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