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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 08/05/2026.
Status of the claims:
Claims 1 – 8, 10 – 14, and 21 – 28 are pending in the application.
Claims 1 and 8 are amended.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5 – 8 and 24 – 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 5, claim 1, from which claim 5 depends, recites “the system comprising a first part intended to be placed in the genital track, the first part comprising the inflatable body and a second part intended to remain outside of the genital track, the second part comprising…the measuring device”, additionally, claim 5 recites “wherein the measuring device is integrated into the inflatable body”. Although, Applicant’s disclosure has support for the system comprising a first part comprising the inflatable body intended to be placed in the genital track and a second part intended to remain outside of the genital track, wherein the second part comprises the measuring device (see Specification paragraphs [0032] and [0106], and Fig. 5), and, separately, has support for measuring device being integrated into the inflatable body (see Specification paragraphs [0027] and [0083], and Figs. 3 – 4), Applicant’s disclosure does not provide support for a measuring device that is integrated in the balloon and comprised within the second part of the system that is intended to remain outside the genital track. Additionally, the Examiner notes that Applicant’s disclosure does not provide support or recitation for combining of the embodiments above. Therefore, claim 5 fails to comply with the written description requirement.
Claims 6 – 8 and 24 – 26 are rejected under 112(a) for being dependent on a claim rejected under 112(a).
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 5 – 8, 10, 11, and 24 – 26 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.
Regarding claim 5, the phrase “wherein the measuring device is integrated into the inflatable body” coupled with the phrase “the system comprising a first part intended to be placed in the genital track, the first part comprising the inflatable body and a second part intended to remain outside of the genital track, the second part comprising…the measuring device” of claim 1, from which claim 5 depends, renders the claim indefinite because it is unclear how the measuring device can be both intended to be placed in the genital track (i.e., integrated with the inflatable body which is a part of the first part of the system) while also being intended to remain outside the genital track (i.e., as a part of the second part of the system).
Regarding claims 10 and 11, the phrase "according to claim 9" renders the claim indefinite because claim 9 has been cancelled and it is unclear which claims Applicant is intending for claims 10 and 11 to be dependent from. For the purpose of examination the claims will be read to be dependent off of claim 1.
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 – 4, 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) and Heitzmann et al (US 5,171,299).
Regarding claim 1, Kring discloses a system (vaginal-pelvic muscle exerciser and birthing trainer) for preparing 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),
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);
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);
the system further comprising a first part (bulb 20), comprising the inflatable body (bulb 20), intended to be placed in the genital tract (paragraph [0062]) and a second part (inflation component 120) intended to remain outside the genital tract (paragraphs [0065 – 0066]) comprising the inflation device (inflation component 120).
However, Kring is silent regarding (i) a measuring device configured to remain outside the genital track and comprising at least one pressure sensor, and at least one computer configured to calculate a quantity of air entering the inflatable body and/or a quantity of air leaving the inflatable body, and (ii) a control device configured to remain outside of the genital track and to collect measurement data of the dimension measured by the measuring device and at least one computer configured to calculate a quantity of air entering the inflatable body and/or a quantity of air leaving the inflatable body. (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).
As to (i) and (ii), 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 (pressure and flow sensors) configured to remain outside the genital track (pressure and flow sensors are integrated in the flow pump 22 which remains outside the genital track), the measuring device comprising at least one pressure sensor (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]), and a control device (computer 14) configured to collect measurement data of the dimension (diameter / cross-section) (paragraph [0024]) the control device (computer 14 of Mashimo) comprising 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 (Examiner’s note: as stated in paragraph [0038] the computer calculates the stepwise / controlled dilation rate which is equal to the amount of air entering the balloon over time).
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 the pressure sensor and flow sensors, 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) and 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] – Mashimo).
However, the Kring in view of Mashimo is silent regarding (iii) wherein the measuring device is configured to measure a dimension of inflatable balloon.
As to (iii), Heitzmann teaches, in the same field of endeavor, a dilation catheter with an inflatable body (balloon 24; which equates bulb 20 of Kring) and a measuring device (microcomputer; which equates to the pressure sensor in combination with the control device and the at least one computer of Mashimo) configured to remain outside of the body (Figs. 2 and 3) and measure the diameter of the inflatable body (balloon 24) for the purpose of providing an added degree of safety and control to a vascular physician conducting balloon angioplasty or similar procedures (abstract, col. 3 lines 5 – 21, col. 4 lines 6 – 36, and Figs. 1 – 3).
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 measuring device of Kring in view of Mashimo to incorporate the microcomputer configured to measure the diameter of the inflatable body via the pressure sensor, based on the teachings of Heitzmann, for the purpose of providing an added degree of safety and control to a vascular physician conducting balloon angioplasty or similar procedures (abstract – Heitzmann).
Regarding claim 3, as discussed above, it would have been obvious to modify the system of Kring to incorporate the measuring device and controller with at least one computer based on the teachings of Mashimo and Heitzmann. Additionally, the combination encompasses wherein the dimension (diameter via pressure sensor as taught by Mashimo and Heitzmann) of the inflatable body (bulb 20 of Kring) corresponds to a cross-section of the inflatable body (bulb 20 of Kring) (Examiner’s note: the pressure of the balloon corresponds to the diameter of the balloon and the diameter of the balloon corresponds to the cross-section of the bulb). Therefore, the combination of the art above encompasses the device as claimed.
Regarding claim 4, as discussed above, it would have been obvious to modify the system of Kring to incorporate the measuring device and controller with at least one computer based on the teachings of Mashimo and Heitzmann. Additionally, Kring discloses wherein 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); and the combination further teaches wherein the system is arranged to determine a diameter (measured by the pressure sensor / microcontroller as taught by Mashimo and Heitzmann) of the inflatable body (bulb 20 of Kring) (paragraph [0024] of Mashimo and col. 4 lines 6 – 36 of Heitzmann). Therefore, the combination of the art above encompasses the device as claimed.
Regarding claim 12, as discussed above, it would have been obvious to modify the system of Kring to incorporate the measuring device and controller with at least one computer based on the teachings of Mashimo and Heitzmann. Additionally, Kring discloses 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).
Regarding claim 23, as discussed above, it would have been obvious to modify the system of Kring to incorporate the measuring device and controller with at least one computer based on the teachings of Mashimo and Heitzmann. Additionally, Kring discloses wherein the bulge (bulge on bulb 20) 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) and Heitzmann et al (US 5,171,299), 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 and a computer to display the data received from the measuring device based on the teachings of Mashimo and Heitzmann.
However, the combination of Kring, Mashimo, and Heitzmann 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 and Heitzmann 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 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) and Heitzmann et al (US 5,171,299), as applied to claim 1, 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 and a computer to display the data received from the measuring device based on the teachings of Mashimo and Heitzmann.
However, the combination of Kring, Mashimo, and Heitzmann 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) and Heitzmann et al (US 5,171,299), 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 in view of Mashimo and Heitzmann 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, Mashimo, and Heitzmann 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 and Heitzmann 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), Heitzmann et al (US 5,171,299), 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, Heitzmann, and Binder Jr teaches the device of claim 13 above.
However, the combination of Kring, Mashimo, Heitzmann, 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, Heitzmann, 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 O’Connor et al (US 2018/0140227 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 configured to measure the inner diameter of the balloon based on the teachings of Mashimo and Heitzmann.
However, the combination of Kring, Mashimo, and Heitzmann 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, O’Connor teaches a method of determining a diameter of a lumen via a pressure, flow rate, and temperature of the inflation fluid (paragraph [0035]).
It should be understood that Kring in view of Mashimo and Heitzmann and O’Connor are known references in the art that teach a means of determining an expansion diameter of structure based on at least in part a pressure sensor (abstract, paragraphs [0023], [0026], and [0042] – Mashimo with col. 3 lines 5 – 21 of Heitzmann ; abstract and paragraph [0035] – O’Connor); 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 method of determining an internal diameter of an object for another, and the results of the substitution would have been predictable and resulted in the modified device of Kring in view of Mashimo and Heitzmann 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 method of determining the inner diameter, as taught by O’Connor, comprises measuring the flow rate and temperature of the inflation lumen, the prior art makes obvious wherein the measuring device of Kring in view of Mashimo, Heitzmann, and, now, O’Connor would additionally comprise a temperature sensor and a flow rate sensor in order to obtain temperature and flow rate which are used to determine said inner diameter.
Claims 1, 3 – 4, 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) and Heitzmann et al (US 5,171,299).
Regarding claim 1, Campbell discloses a system (vaginal-pelvic muscle exerciser) for preparing 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),
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);
the system further comprising a first part (balloon member 116), comprising the inflatable body (balloon member 116), intended to be placed in the genital tract (paragraphs [0005], [0026 – 0028]) and a second part (syringe 135) intended to remain outside the genital tract (Fig. 8C) comprising the inflation device (syringe 135).
However, Campbell is silent regarding (i) a measuring device configured to remain outside the genital track and comprising at least one pressure sensor, and at least one computer configured to calculate a quantity of air entering the inflatable body and/or a quantity of air leaving the inflatable body, and (ii) a control device configured to remain outside of the genital track and to collect measurement data of the dimension measured by the measuring device and at least one computer configured to calculate a quantity of air entering the inflatable body and/or a quantity of air leaving the inflatable body. (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).
As to (i) and (ii), 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 (pressure and flow sensors) configured to remain outside the genital track (pressure and flow sensors are integrated in the flow pump 22 which remains outside the genital track), the measuring device comprising at least one pressure sensor (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]), and a control device (computer 14) configured to collect measurement data of the dimension (diameter / cross-section) (paragraph [0024]) the control device (computer 14 of Mashimo) comprising 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 (Examiner’s note: as stated in paragraph [0038] the computer calculates the stepwise / controlled dilation rate which is equal to the amount of air entering the balloon over timed).
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 pressure and flow rate sensor(s), 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) and 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] – Mashimo).
However, the combination of Campbell in view of Mashimo is silent regarding (iii) wherein the measuring device is configured to measure a dimension of inflatable balloon.
As to (iii), Heitzmann teaches, in the same field of endeavor, a dilation catheter with an inflatable body (balloon 24; which equates balloon member 116 of Campbell) and a measuring device (microcomputer; which equates to the pressure sensor in combination with the control device and the at least one computer of Mashimo) configured to remain outside of the body (Figs. 2 and 3) and measure the diameter of the inflatable body (balloon 24) for the purpose of providing an added degree of safety and control to a vascular physician conducting balloon angioplasty or similar procedures (abstract, col. 3 lines 5 – 21, col. 4 lines 6 – 36, and Figs. 1 – 3).
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 measuring device of Campbell in view of Mashimo to incorporate the microcomputer configured to measure the diameter of the inflatable body via the pressure sensor, based on the teachings of Heitzmann, for the purpose of providing an added degree of safety and control to a vascular physician conducting balloon angioplasty or similar procedures (abstract – Heitzmann).
Regarding claim 4, as discussed above, it would have been obvious to modify the device of Campbell to incorporate the measuring device and control device with the at least one computer in view of Mashimo and Heitzmann. Additionally, Campbell discloses the inflatable body having a substantially circular cross-section (Fig. 6).
Regarding claim 12, as discussed above, it would have been obvious to modify the device of Campbell to incorporate the measuring device and control device with the at least one computer in view of Mashimo and Heitzmann. Additionally, Campbell discloses the second closed end comprising a bulge (tapered tip 122) (paragraph [0135] and Fig. 5).
Regarding claim 23, as discussed above, it would have been obvious to modify the device of Campbell to incorporate the measuring device and control device with the at least one computer in view of Mashimo and Heitzmann. 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).
Regarding claim 27, as discussed above, it would have been obvious to modify the device of Campbell to incorporate the measuring device and control device with the at least one computer in view of Mashimo and Heitzmann. Additionally, Campbell discloses 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).
Regarding claim 28, as discussed above, it would have been obvious to modify the device of Campbell to incorporate the measuring device and control device with the at least one computer in view of Mashimo and Heitzmann. Additionally, Campbell discloses 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)).
Examiner’s Note
Claims 5 – 8 and 24 – 26, as interpreted by the Examiner in the 112(b) rejection, are free from prior art, as the prior art does not disclose or make obvious a measuring device that is both intended to be placed within a body cavity and intended to remain outside of the body cavity.
Response to Arguments
Applicant's arguments filed 08/05/2026 have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s arguments “However, a flow sensor, even when combined with pressure sensors, is not sufficient to calculate an amount of air as claimed. As stated at least in paragraph 111 of the present application, other values are necessary to calculate the "quantity of air entering or leaving the inflatable body," which is calculated by the computer and determined via information communicated by the motor”, it should be understood that the neither claim 1 or claims 10 and 11 as currently written require the measured air to be determined by the air blown by the motor nor by the opening time of a solenoid only that the amount of air (fluid) flowing into the balloon is calculated by the computer and based on information from a motor and/or a solenoid. The claims do not require specific information to be shared between the motor/solenoid and the computer / controller. Additionally, paragraph [0038] of Mashimo states the computer calculates the stepwise / controlled dilation rate which is equal to the amount of air entering the balloon over time. Therefore, the computer is configured (i.e., capable) of calculating the amount of air (fluid) entering the inflatable body as required by the claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
