DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 3/23/2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 13 is objected to because of the following informalities:
in claim 13, line 4: “a flexible PCB” should be “a flexible printed circuit board (PCB)”.
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 13-14 and 16-20 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 13 recites “step (b)” in line 17, but it is not clear which step (b) is being referred to in this recitation. Is it the initial step (b) in lines 7-10 or is it one of the one or more repeated steps (b) implicit in line 15? Clarification is required.
Claim 13 recites “step (c)” in line 18, but it is not clear which step (c) is being referred to in this recitation. Is it the initial step (c) in lines 11-14 or is it one of the one or more repeated steps (c) implicit in line 15? Clarification is required.
Claims 14 and 16-20 are rejected by virtue of their dependence from claim 13.
Claim 14 recites “steps (b) and (c) occur in real-time” in line 1, but it is not clear if this recitation is referring to:
(1) all the steps (b) and all the steps (c) OR
(2) one step (b) and one step (c).
The confusion stems from claim 13 referring to an initial step (b) in lines 7-10 and a repeat of step (b) in line 15 and refers to an initial step (c) in lines 11-14 and a repeat of step (c) in line 15. Clarification is required.
Claim 17 recites “wherein steps (b) and (c) are repeated five or six times daily and/or wherein steps (b) and (c) are performed every four to six weeks” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “(d) repeating steps (b) and (c) one or more times” of claim 13, line 15. Both recitations speak to repeating steps (b) and (c), but the recitations are not linked in any meaningful way. This ambiguity renders claim 17 indefinite.
Claim 19 recites “wherein the subject activates the first set of muscles to perform a Kegel maneuver and limits activation of the second set of muscles to refrain from performing a Valsalva maneuver” in lines 1-3, which is indefinite.
First, it is not clear if either “a Kegel maneuver” or “a Valsalva maneuver” is the same as, related to, or different from “a pelvic floor exercise” of claim 13, line 9. Both recitations are pelvic floor exercises, but the recitations are not linked in any meaningful way. This ambiguity renders claim 19 indefinite.
Second, it is not clear if the activation of the first set of muscles is the same as, related to, or different from the action “to activate a first set of pelvic floor muscles that treat the pelvic floor disorder” of claim 13, lines 19-20. Both recitations referring to the activation of the first set of muscles, but the recitations are not linked in any meaningful way. This ambiguity renders claim 19 indefinite.
Third, it is not clear if the limiting of the activation of the second set of muscles is the same as, related to, or different from the action “to limit activation of a second set of pelvic floor muscles that exacerbate the pelvic floor disorder” of claim 13, lines 20-21. Both recitations referring to the limiting of the activation of the second set of muscles, but the recitations are not linked in any meaningful way. This ambiguity renders claim 19 indefinite.
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 negatived by the manner in which the invention was made.
Claims 1-3, 5-7, 9 and 11-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2010/0174218 (Shim)(previously cited), in view of U.S. Patent Application Publication No. 2010/0298895 (Ghaffari)(previously cited).
Shim teaches a device (paragraphs 0003, 0024-0025, 0029, 0064-0065, 0111-0114, 0124-0127, 0137, 0160, and 0192 of Shim) comprising a plurality of microelectromechanical accelerometers positioned along a length of the device (paragraphs 0015, 0018, 0035-0040, 0099, 0187, 0227, 0235-0237, and 0241 of Shim), one or more additional sensors capable of providing real-time data selected from the group consisting of pressure, position, movement, pressure, and flow (0015, 0018, 0026, 0035-0041, 0053, 0086-0087, 0091, 0099, 0187, 0227, 0235-0237, and 0241 of Shim), and an inflatable component (paragraphs 0049-0051, 0061, 0112-0113, 0125-0126, 0171, 0183-0184, 0210, 0244, 0250-0252, and 0254 of Shim). Shim does not explicitly disclose how the accelerometers and additional sensors are physically interrelated to the inflatable component. Ghaffari teaches stretchable electronic circuits on inflatable surfaces made by printing (abstract and paragraphs 0010-0020, 0073-0084, 0090-0091, 0107, and 0111-0112 of Ghaffari). It would have been obvious to one of ordinary skill in the art at the time of invention to embody the accelerometers, additional sensors, and other components with its accompanying wiring as a flexible printable circuit on the inflatable component since a method of incorporating the accelerometers and additional sensors with the inflatable component is required and Ghaffari teaches one such method and/or it creates a more compact assembly.
Paragraphs 0015-0018, 0026, 0035-0040, 0053, 0084-0086, 0091, 0099-0101, 0104-0117, 0187-0188, 0192, 0227, 0235-0237, 0241, 0274 of Shim discloses that variables are measured during exercising which suggests real-time data. Shim also teaches that the system is capable of transmitting the signals wirelessly for display (paragraphs 0023, 0075-0078, 0081-0082, 0084, 0095, 0154, 0275, and 0277 of Shim). Ghaffari discloses that a graphical user interface of a computer is a suitable display (paragraph 0236-0237, 0243, 0257, and 0262 of Ghaffari). It would have been obvious to one of ordinary skill in the art at the time of invention to use a graphical user interface of a computer, as suggested by Ghaffari, to externally display the data from the sensors since a method of display is required and Ghaffari teaches one display and/or it is a simple substitution of one known element for another to obtain predictable results.
Paragraphs 0015-0018, 0026, 0035-0040, 0053, 0084-0086, 0091, 0099-0101, 0104-0117, 0187-0188, 0192, 0227, 0235-0237, 0241, 0274 of Shim discloses that variables are measured during exercising which suggests real-time data. Shim and/or Ghaffari also teaches that the system is capable of transmitting the signals wirelessly using a transmitter for transmission to the display (paragraphs 0023, 0075-0078, 0081-0082, 0084, 0095, 0154, 209, 0275, and 0277 of Shim; paragraphs 0037, 0117, 0123-0124, 0134, and 0149 of Ghaffari). It would have been obvious to one of ordinary skill in the art at the time of invention to use wireless transmission of the data via a transmitter for transmission to the display since it would make the device less cumbersome.
With respect to claim 1, the combination teaches or suggests an intravaginal device comprising
a plurality of position sensors mounted on a flexible printed circuit board (PCB) of the device (the accelerometers and additional sensors with its accompanying wiring mounted on a flexible printable circuit of the inflatable component) and
a transmitter (the transmitter suggested by Shim and/or Ghaffari),
wherein the device is configured to: (a) provide real-time position data from the position sensors in a vagina (paragraphs 0015, 0017-0018, 0026, 0035-0040, 0053, 0084-0086, 0091, 0099-0101, 0104-0117, 0187-0188, 0192, 0227, 0235-0237, 0241, 0274 of Shim discloses that the variables are measured during exercising which suggests real-time data); and (b) transmit the real-time position data wirelessly via the transmitter to a graphical user interface (the wireless transmission via the transmitter, as suggested by Shim and Ghaffari, to the graphical user interface suggested by Ghaffari) that is configured to display a position of the vagina based on the real-time position data (since the graphical user interface is not part of the claimed invention, the intended use of the graphical interface does not physically distinguish the combination from the claimed device);
wherein the real-time position data are configured to distinguish between activation of a first set of pelvic floor muscles that treat a pelvic floor disorder and activation of a second set of pelvic floor muscles that exacerbate the pelvic floor disorder when the device is used during performance of a pelvic floor exercise (the intended use of the data does not physically distinguish the combination from the claimed device).
With respect to claim 2, the combination teaches or suggests that the sensors are accelerometers (the accelerometers of Shims).
With respect to claim 3, the combination teaches or suggests that the sensors are positioned along a length of the device (paragraphs 0015, 0018, 0028, 0035-0040, 0099, 0170, 0187, 0214, 0227, 0233, 0235-0237, and 0241 of Shim).
With respect to claim 5, the combination teaches or suggests that the device further comprises a pressure sensor (paragraphs 0015, 0018, 0026, 0035-0040, 0053, 0091, 0099, 0187, 0227, 0235-0237, and 0241 of Shim).
With respect to claim 6, the combination teaches or suggests that the device is configured to provide real-time pressure data from the pressure sensor (paragraphs 0015, 0018, 0026, 0035-0040, 0053, 0091, 0099, 0187, 0227, 0235-0237, and 0241 of Shim; paragraphs 0015, 0017-0018, 0026, 0035-0040, 0053, 0084-0086, 0091, 0099-0101, 0104-0117, 0187-0188, 0192, 0227, 0235-0237, 0241, 0274 of Shim discloses that the variables are measured during exercising which suggests real-time data).
With respect to claim 7, the combination teaches or suggests that the device further comprises at least one of a gyroscope, an inductive noncontact position sensor, a string potentiometer, a linear variable differential transformer, a potentiometer, a capacitive transducer, an Eddy-current sensor, a Hall effect sensor, an optical proximity sensor (paragraphs 0041 and 0237 of Shim), a piezo-electric transducer (paragraph 0235 of Shim), and a photodiode array.
With respect to claim 9, the combination teaches or suggests that the device further comprises at least one of a force collector (paragraphs 0035-0037 of Shim), a piezo-resistive sensor, a capacitive sensor, an electromagnetic sensor, a piezo-electric sensor (paragraph 0235 of Shim), an optical sensor (paragraphs 0041 and 0237 of Shim), a potentiometric sensor, a resonant sensor, a thermal sensor, an ionization sensor, an ultrasonic sensor, a density sensor, a resistive sensor, a surface acoustic wave sensor, a capacitive sensor, an infrared sensor, an optical imaging sensor, a dispersive signal technology sensor, and an acoustic pulse recognition sensor.
With respect to claim 11, the combination teaches or suggests that the device further comprises a plurality of inflatable compartments (paragraphs 0171 and 0252-0255 of Shim).
With respect to claim 12, the combination teaches or suggests that at least one of the plurality of sensors has multiple measurement and reporting capabilities (paragraphs 0015, 0018, 0026, 0035-0040, 0053, 0091, 0099, 0187, 0227, 0235-0237, and 0241 of Shim).
Claims 13-14 and 16-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shim, in view of Ghaffari, and further in view of U.S. Patent Application Publication No. 2004/0260207 (Eini)(previously cited), and further in view of U.S. Patent No. 5,733,230 (Sawchuck), and further in view of U.S. Patent Application Publication No. 2011/0077500 (Shakiba)(previously cited).
Shim teaches a device (paragraphs 0003, 0024-0025, 0029, 0064-0065, 0111-0114, 0124-0127, 0137, 0160, and 0192 of Shim) comprising a plurality of microelectromechanical accelerometers positioned along a length of the device (paragraphs 0015, 0018, 0035-0040, 0099, 0187, 0227, 0235-0237, and 0241 of Shim), one or more additional sensors capable of providing real-time data selected from the group consisting of pressure, position, movement, pressure, and flow (0015, 0018, 0026, 0035-0041, 0053, 0086-0087, 0091, 0099, 0187, 0227, 0235-0237, and 0241 of Shim), and an inflatable component (paragraphs 0049-0051, 0061, 0112-0113, 0125-0126, 0171, 0183-0184, 0210, 0244, 0250-0252, and 0254 of Shim). Shim does not explicitly disclose how the accelerometers and additional sensors are physically interrelated to the inflatable component. Ghaffari teaches stretchable electronic circuits on inflatable surfaces made by printing (abstract and paragraphs 0010-0020, 0073-0084, 0090-0091, 0107, and 0111-0112 of Ghaffari). It would have been obvious to one of ordinary skill in the art at the time of invention to embody the accelerometers, additional sensors, and other components with its accompanying wiring as a flexible printable circuit on the inflatable component since a method of incorporating the accelerometers and additional sensors with the inflatable component is required and Ghaffari teaches one such method and/or it creates a more compact assembly.
Paragraphs 0015-0018, 0026, 0035-0040, 0053, 0084-0086, 0091, 0099-0101, 0104-0117, 0187-0188, 0192, 0227, 0235-0237, 0241, 0274 of Shim discloses that variables are measured during exercising which suggests real-time data. Shim also teaches that the system is capable of transmitting the signals wirelessly for display (paragraphs 0023, 0075-0078, 0081-0082, 0084, 0095, 0154, 0275, and 0277 of Shim). Ghaffari discloses that a graphical user interface of a computer is a suitable display (paragraph 0236-0237, 0243, 0257, and 0262 of Ghaffari). It would have been obvious to one of ordinary skill in the art at the time of invention to use a graphical user interface of a computer, as suggested by Ghaffari, to externally display the data from the sensors since a method of display is required and Ghaffari teaches one display and/or it is a simple substitution of one known element for another to obtain predictable results.
Paragraphs 0015-0018, 0026, 0035-0040, 0053, 0084-0086, 0091, 0099-0101, 0104-0117, 0187-0188, 0192, 0227, 0235-0237, 0241, 0274 of Shim discloses that variables are measured during exercising which suggests real-time data. Shim and/or Ghaffari also teaches that the system is capable of transmitting the signals wirelessly using a transmitter for transmission to the display (paragraphs 0023, 0075-0078, 0081-0082, 0084, 0095, 0154, 209, 0275, and 0277 of Shim; paragraphs 0037, 0117, 0123-0124, 0134, and 0149 of Ghaffari). It would have been obvious to one of ordinary skill in the art at the time of invention to use wireless transmission of the data via a transmitter for transmission to the display since it would make the device less cumbersome.
Shim teaches measuring acceleration and/or displacement of the patient’s vagina and pelvic floor during a Kegel movement. In particular, paragraphs 0015, 0018, 0035-0040, 0053, 0058, 0091, 0097, 0099, 0118, 0187, 0214, 0216, 0218-0219, 0223-0224, 0227, 0234-0237, and 0241 of Shim relate to measuring acceleration and/or displacement while paragraphs 0012-0013 and 0015-0034, 0043-0044, 0048, and 0066 of Shim relate to exercising which includes Kegel movement. Shim teaches the use of the data to lead or guide the user during the pelvic exercise, i.e., visual feedback to guide the user during exercises (abstract, paragraphs 0002, 0015-0016, 0075, 0077-0078, 0086, 0152, 0187-0188, 0274, 0280 of Shim). Eini discloses that the proper execution of Kegel exercises is important so as to reap the expected benefits and feedback from measuring devices to ensure the correctness of the exercise will assist in the proper execution of such exercises (paragraph 0165 of Eini). It would have been obvious to one of ordinary skill in the art at the time of invention to manipulate the patient’s anatomical state to a position to optimize Kegel efficiency using the feedback of the combination so as to assist in the proper execution of Kegel exercises so as to reap the expected benefits.
Sawchuck teaches that proper Kegel exercises involve avoidance of Valsalva-type efforts (col. 8, line 64 to col. 9, line 23 of Sawchuck). It would have been obvious to one of ordinary skill in the art at the time of invention to avoid Valsalva-type efforts during the Kegel exercises so as to optimize the benefits of the Kegel exercises.
The combination teaches or suggest the display of the acceleration and/or displacement of portions of the patient’s vagina during the Kegel exercises. Shakiba discloses that the display may include a relaxed state and the state during the performance of the exercise so as to see the full range of prolapse (abstract and paragraphs 0046, 0055-0056, 0061, 0067, and 0102 of Shakiba). It would have been obvious to one of ordinary skill in the art at the time of invention to display of the acceleration and/or displacement of portions of the patient’s vagina in a relaxed state and during the Kegel exercises so as to see the full range of prolapse.
Shim teaches that the pelvic exercise system may allow a user to strengthen and/or tone her pelvic muscles (paragraphs 0016-0017 and 0188 of Shim). It is also known that repeated use of an exercise system achieves such strengthening or toning (paragraph 0012 of Shim). The quantity of exercises, the time periods between the exercises, and time span to perform the exercises are all functions of the strengthening or toning that has occurred relative to what is desired. As such, the quantity of exercises, the time periods between the exercises, and time span to perform the exercises are results-effective variables that would have been optimized through routine experimentation based on the factors of the strengthening or toning that has occurred relative to what is desired. It would have been obvious to one of ordinary skill in the art at the time of invention to select the quantity of exercises, the time periods between the exercises, and time span to perform the exercises so as to obtain the desired strengthening or toning. In view of the above, the combination teaches or suggests that the method further comprises repeating steps (b) and (c) one or more times.
With respect to claim 13, the combination teaches or suggests a method for treating a female subject with a pelvic floor disorder comprising the steps of:
(a) inserting into the subject's vagina an intravaginal device comprising a plurality of position sensors mounted on a flexible PCB of the device (the accelerometers and additional sensors with its accompanying wiring mounted on a flexible printable circuit of the inflatable component) and a transmitter (the transmitter suggested by Shim and/or Ghaffari), wherein the device transmits real-time position data generated by the plurality of position sensors wirelessly via the transmitter to a graphical user interface (the wireless transmission via the transmitter, as suggested by Shim and Ghaffari, to the graphical user interface suggested by Ghaffari; paragraphs 0003, 0023-0025, 0029, 0064-0065, 0075, 0077-0078, 0082, 0084, 0095, 0111-0114, 0124-0127, 0137, 0154, 0160, 0165-0166, 0169, 0192, 0231, 0248, 0251, 0275, and 0277 of Shim; paragraphs 0015, 0017-0018, 0026, 0035-0040, 0053, 0084-0086, 0091, 0099-0101, 0104-0117, 0187-0188, 0192, 0227, 0235-0237, 0241, 0274 of Shim discloses the variable measured during exercising which suggests real-time data; abstract and paragraphs 0046, 0055-0056, 0061, 0067, and 0102 of Shakiba),
(b) displaying the real-time position data on the graphical user interface as a visual representation of a position of the subject's vagina prior to performance of a pelvic floor exercise by the subject, and recording the real-time position data that is generated prior to the performance of the pelvic floor exercise (the above 103 analysis regarding the displaying and recording of data during the relaxed state; paragraphs 0023, 0075, 0077-0078, 0082, 0084, 0095, 0154, 0165-0166, 0169, 0231, 0275, and 0277 of Shim; abstract and paragraphs 0046, 0055-0056, 0061, 0067, and 0102 of Shakiba; data being stored is taught in paragraph 0272 of Shim and paragraphs 0010 and 0242 of Ghaffari and it would have been obvious to store such data for later analysis and/or to review trends);
(c) displaying the real-time position data on the graphical user interface as a visual representation of a position of the subject's vagina corresponding to a position of the device that is generated by the plurality of position sensors during the performance of the pelvic floor exercise by the subject, and recording the real-time position data that is generated during the performance of the pelvic floor exercise (the above 103 analysis regarding the displaying and recording of data during the Kegel exercise; paragraphs 0023, 0075, 0077-0078, 0082, 0084, 0095, 0154, 0165-0166, 0169, 0231, 0275, and 0277 of Shim; abstract and paragraphs 0046, 0055-0056, 0061, 0067, and 0102 of Shakiba; data being stored is taught in paragraph 0272 of Shim and paragraphs 0010 and 0242 of Ghaffari and it would have been obvious to store such data for later analysis and/or to review trends);
(d) repeating steps (b) and (c) one or more times (the repetition suggested by the above repetition analysis); and
(e) generating pelvic floor position information based on the position of the subject's vagina that is recorded during step (b) and the position of the subject's vagina that is recorded during step (c) and using the pelvic floor position information to guide the subject via the visual representation during at least one step (c) to activate a first set of pelvic floor muscles that treat the pelvic floor disorder (the guidance during the Kegel exercise suggested by Shim) and to limit activation of a second set of pelvic floor muscles that exacerbate the pelvic floor disorder (the combination teaches the optimization of the Kegel exercise such that it necessarily includes limiting activation of those muscles that hinder benefits of the Kegel exercise and by extension that exacerbate the pelvic floor disorder; also, the avoidance of Valsalva-type efforts during the Kegel exercises suggested by Sawchuck).
With respect to claim 14, the combination teaches or suggests that steps (b) and (c) occur in real-time (paragraphs 0015, 0017-0018, 0026, 0035-0040, 0053, 0084-0086, 0091, 0099-0101, 0104-0117, 0187-0188, 0192, 0227, 0235-0237, 0241, 0274 of Shim discloses that the variables are measured during exercising which suggests real-time data).
With respect to claim 16, the combination teaches or suggests that the graphical user interface is a display screen of a computer or smart phone (the graphical user interface of Ghaffari on a computer; paragraphs 0237, 0243, 0257, and 0262 of Ghaffari).
With respect to claims 17-18, the combination teaches or suggests that steps (b) and (c) are repeated five or six times daily and/or wherein steps (b) and (c) are performed every four to six weeks and that the method strengthens the first set of pelvic floor muscles of the subject (Shim teaches that the pelvic exercise system may allow a user to strengthen and/or tone her pelvic muscles (paragraphs 0016-0017 and 0188 of Shim). It is also known that repeated use of an exercise system achieves such strengthening or toning (paragraph 0012 of Shim). The quantity of exercises, the time periods between the exercises, and time span to perform the exercises are all functions of the strengthening or toning that has occurred relative to what is desired. As such, the quantity of exercises, the time periods between the exercises, and time span to perform the exercises are results-effective variables that would have been optimized through routine experimentation based on the factors of the strengthening or toning that has occurred relative to what is desired. It would have been obvious to one of ordinary skill in the art at the time of invention to select the quantity of exercises, the time periods between the exercises, and time span to perform the exercises so as to obtain the desired strengthening or toning. In view of the above, the combination teaches or suggests (1) that steps (b) and (c) are repeated five or six times daily, (2) that steps (b) and (c) are performed every four to six weeks, and (3) that the method strengthens the first set of pelvic floor muscles of the subject).
Alternatively, with respect to claim 18, the combination teaches or suggests that the method strengthens the first set of pelvic floor muscles of the subject (paragraphs 0012-0013, 0015-0040, 0043-0044, 0048, 0053, 0058, 0066, 0091, 0097, 0099, 0118, 0187, 0214, 0216, 0218-0219, 0223-0224, 0227, 0234-0237, and 0241 of Shim; paragraph 0165 of Eini; alternatively, the combination performs the claimed steps, thus it is inherent that the combination’s steps result in the same benefits as the claimed steps).
With respect to claim 19, the combination teaches or suggests that the subject activates the first set of muscles to perform a Kegel maneuver (the Kegel exercise of Shim) and limits activation of the second set of muscles to refrain from performing a Valsalva maneuver (the combination teaches the optimization of the Kegel exercise such that it necessarily includes limiting activation of those muscles that hinder benefits of the Kegel exercise and by extension that limit activation of the second set of muscles to refrain from performing a Valsalva maneuver; also, the avoidance of Valsalva-type efforts during the Kegel exercises suggested by Sawchuck).
With respect to claim 20, the combination teaches or suggests that the pelvic floor disorder is pelvic floor weakness or pelvic organ prolapse (POP)(paragraphs 0012-0013, 0015-0040, 0043-0044, 0048, 0053, 0058, 0066, 0091, 0097, 0099, 0118, 0187, 0214, 0216, 0218-0219, 0223-0224, 0227, 0234-0237, and 0241 of Shim; paragraph 0165 of Eini).
Response to Arguments
The Applicant’s arguments filed on 3/23/2026 have been fully considered.
Drawing objections
In view of the amendments to the drawings filed on 3/23/2026, the drawing objection is withdrawn.
Claim objections
There are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 3/23/2026, the claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
In view of the claim amendments filed on 3/23/2026, the claim rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, are withdrawn.
Prior art rejection of claim 1
The Applicant asserts:
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These arguments are not persuasive for the same reasons provided by the Examiner in the Office Action mailed on 12/23/2025, which are herein incorporated by reference.
The Applicant asserts:
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These arguments are not persuasive since the feature of a “graphical user interface that is configured to display a position of the vagina based on the real-time position data” is merely intended use. The graphical interface is not part of the claimed intravaginal device, thus, its configuration does not physically distinguish the combination from the claimed device. Also, the feature of “wherein the real-time position data are configured to distinguish between activation of a first set of pelvic floor muscles that treat a pelvic floor disorder and activation of a second set of pelvic floor muscles that exacerbate the pelvic floor disorder when the device is used during performance of a pelvic floor exercise” is merely intended use of the data with respect to an action performed by the patient. The use of the data does not physically distinguish the combination from the claimed device.
The Applicant then refers to the Declaration of Dr. Samantha Pulliam (the Pulliam Declaration) to show surprising results obtained by the present Applicant with the claimed device. However, the declaration and the arguments are not commensurate with the rejection of claim 1. Claim 1 merely requires a device that is insertable into a vagina having a plurality of position sensors mounted on a flexible printed circuit board (PCB) of the device and a transmitter. That is all. All of the analysis/arguments and statements of the Pulliam Declaration are not directly tied to this simple structure, but to a more detailed process that is not part of the claimed device and is therefore not required by the prior art. Since the nexus between the claimed physical structure of claim 1 and the Applicant’s arguments/analysis and the Pulliam Declaration is lacking, such arguments and declaration are not persuasive.
In view of the above, the rejection of claim 1 based on Shim and Ghaffari is proper.
The rejection of dependent claims 2-3, 6-7, 9 and 11-12 are equally proper since the rejection of claim 1 is proper and Shim and Ghaffari teach or suggest all the features of these dependent claims.
Prior art rejection of claim 14
The Applicant asserts:
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These arguments are not persuasive for the same reasons provided by the Examiner in the Office Action mailed on 12/23/2025, which are herein incorporated by reference.
The Applicant then refers to the Declaration of Dr. Samantha Pulliam (the Pulliam Declaration) to show surprising results obtained by the present Applicant with the claimed method. In particular, it appears that the Pulliam Declaration states:
(1) Women activate the wrong muscles or perform a maneuver that can harm pelvic floor health;
(2) two publications support point (1);
(3) the claimed method solves the problem of point (1) by employing visual feedback during the performance of the Kegel maneuver to ensure the exercise is performed correctly;
(4) there was a 12-week clinical trial that shows all the female patients experienced improvement when the method was carried out with the feedback ensuring proper Kegel exercising; and
(5) three more publications describing more clinical trials showing that female patients experienced improvement when the method was carried out with the feedback ensuring proper Kegel exercising.
However, these points are not persuasive. The prior art already shows that the feedback during Kegel exercises are known and that feedback to ensure proper Kegel exercises improves the benefits of the exercise. For example, Shim teaches the use of the data to lead or guide the user during the pelvic exercise, i.e., visual feedback to guide the user during exercises (abstract, paragraphs 0002, 0015-0016, 0075, 0077-0078, 0086, 0152, 0187-0188, 0274, 0280 of Shim). Also, paragraph 0165 of Eini discloses:
…For one example, urinary incontinence is sometimes treatable by the use of Kegel exercises or other exercises. Yet it is widely known that Kegel exercises are difficult to learn to do properly, and that a large percentage of the patients attempting to treat urinary incontinence through the use of such exercises do not reap the expected benefit because they do not properly execute the exercise. In this context, use of device 502 can benefit such patients both by providing immediate feedback during execution of an exercise as to the correctness of the exercise, and by providing long-term feedback to a patient by measuring changes in muscle strength over the course of a treatment program.
Thus, the improvements in the treatment when provide feedback during Kegel exercises are not surprising or unexpected but widely known. As a result, the claimed method of providing feedback to the user during Kegel exercising which results in improved execution and benefits of such exercises is not unexpected, but known and desired. The Pulliam Declaration allegedly supporting unexpected results is not persuasive.
In view of the above, the rejection of claim 13 based on Shim, Ghaffari, Eini, and Shakiba is proper.
The rejection of dependent claims 14 and 16-20 are equally proper since the rejection of claim 13 is proper and Shim, Ghaffari, Eini, and Shakiba teach or suggest all the features of these dependent claims.
Double patenting rejection
In view of the filing of the terminal disclaimer filed on 3/25/2026, the double patenting rejections based on claims 1-5 and 7-10 of U.S. Patent No. 10,470,862 (previously cited) in view of Shim, and further in view of Ghaffari has been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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