DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement filed 4/5/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The references that have been struck-through on this IDS are references in which a copy has not been supplied in this application or any of the parent application to which this application claims priority. These references that have been struck-through have not been considered.
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
Claims 1, 9 and 13 are objected to because of the following informalities:
in claim 1, line 6: “the position” before “of the vagina” should be “a position”;
in claim 9, line 4: the semicolon should be a comma;
in claim 13, line 5: “generated” should be inserted before “prior to”;
in claim 13, line 8: “generated” should be inserted before “during”; and
in claim 13, line 11: “generated” should be inserted before “during”.
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 1-20 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 1 recites “An intravaginal device comprising a plurality of sensors mounted on a flexible printed circuit board (PCB) attached to or incorporated within the device” in lines 1-2, but it is not clear if the PCB is part of the claimed device. The expression “a plurality of sensors mounted on a flexible printed circuit board (PCB)” suggests that the PCB is part of the device, but the expression “a flexible printed circuit board (PCB) attached to or incorporated within the device” suggests that the PCB is separate and distinct from the device. This confusion renders claim 1 indefinite.
Claim 1 recites “wherein the device is configured to…transmit the real-time data wirelessly to a graphical user interface” in lines 2-5, but it is not clear where this functionality is coming from since the claimed device only has a plurality of sensors and possibly the PCB. Neither of these elements is recited as being capable of transmitting data wirelessly.
Claim 1 recites “the position data” in line 6, but it is not clear if this recitation is the same as, related to, or different from “real-time data selected from position… of the vagina and/or urethra” of claim 1, lines 3-4. If they are the same, consistent terminology should be used. Also, if they are the same, it is not clear if the recitation “provide real-time data selected from position, movement, pressure, and flow of the vagina and/or urethra” is required to mean “provide real-time position data of the vagina”. Further, if they are the same, is “an anatomical organ of interest” in line 7 supposed to be referring to the “urethra” of claim 1, line 4? If they are different, there is insufficient antecedent basis for “the position data” of line 6 in this claim. Also, if they are different, it is not clear what meaning “wherein the position data relates to at least one of the position of the vagina and the position of an anatomical organ of interest relative to an anatomical or external reference point” is supposed to be. Where did the position data come from? What is the relation of the position data to the claimed device? The issues render claim 1 indefinite.
Claim 1 recites “the vagina” in line 3 and “the position of an anatomical organ of interest” in lines 6-7 in which there are insufficient antecedent bases for these recitations in the claim.
Claims 2-20 are rejected by virtue of their dependence from claim 1.
Claim 4 recites “wherein the real-time data is position or movement data” in line 1, but it is not clear if this recitation is the same as, related to, or different from “real-time data selected from position, movement…of the vagina and/or urethra” of claim 1, lines 3-4. The relationship between these two recitations should be made clear and consistent terminology should be used.
Claim 5 recites “wherein the device comprises a pressure sensor” in line 1, but it is not clear if this recitation is a subset of “a plurality of sensors” of claim 1, line 1. The relationship between these two recitations should be made clear.
Claim 6 is rejected by virtue of its dependence from claim 5.
Claim 6 recites “wherein the data is pressure data” in line 1, but it is not clear if this recitation is the same as, related to, or different from “real-time data selected from position, movement, pressure, and flow of the vagina and/or urethra” of claim 1, lines 3-4. The relationship between these two recitations should be made clear and consistent terminology should be used.
Claim 8 recites “the position and movement data” in line 1, but it is not clear if this recitation is the same as, related to, or different from “real-time data selected from position, movement, pressure, and flow of the vagina and/or urethra” of claim 1, lines 3-4. The relationship between these two recitations should be made clear and consistent terminology should be used.
Claim 10 recites “wherein the device is inflatable” in line 1, but it is not clear where this functionality is coming from since the claimed device only has a plurality of sensors and possibly the PCB. Neither of these elements is recited as being inflatable.
Claim 13 recites “a graphical user interface” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a graphical user interface” of claim 1, line 5. If they are the same, “a graphical user interface” of claim 13, line 3 should be “the graphical user interface”. If they are different or related, their relationship should be made clear, they should be clearly distinguished from each other, and any subsequent mention of the graphical user interface (claim 13, line 6; claim 15, line 2; and claim 16, line 1) should make clear which recitation is being referred to.
Claim 13 recites “the position” in line 5, but it is not clear if this recitation is referring to the position in claim 1, line 3, the position of the vagina in claim 1, line 6, the position of the anatomical organ of interest in claim 1, lines 6-7, or the position of the device in claim 13, line 4. Clarification is required.
Claim 13 recites “the position” in line 8, but it is not clear if this recitation is referring to the position in claim 1, line 3, the position of the vagina in claim 1, line 6, the position of the anatomical organ of interest in claim 1, lines 6-7, the position of the device in claim 13, line 4, or the position in claim 13, line 5. Clarification is required.
Claim 13 recites “the pelvic floor” in lines 12-13 in which there is insufficient antecedent basis for this limitation in the claim.
Claims 14-20 are rejected by virtue of their dependence from claim 13.
Claim 18 recites “pelvic floor muscles” in line 1, but it is not clear if this recitation is the same as, related to, or different from the pelvic floor muscles of claim 13, line 12 or the pelvic floor muscles of claim 13, line 13. Clarification is required.
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 1-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2010/0174218 (Shim), in view of U.S. Patent Application Publication No. 2010/0298895 (Ghaffari).
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), 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, 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 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.
With respect to claim 1, the combination teaches or suggests an intravaginal device comprising
a plurality of sensors mounted on a flexible printed circuit board (PCB) attached to or incorporated within the device (the accelerometers and additional sensors with its accompanying wiring mounted on a flexible printable circuit of the inflatable component),
wherein the device is configured to: a) provide real-time data selected from position, movement, pressure, and flow of the vagina and/or urethra (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 data wirelessly to a graphical user interface (the wireless transmission of Shim to the graphical user interface suggested by Ghaffari);
wherein the position data relates to at least one of the position of the vagina and the position of an anatomical organ of interest relative to an anatomical or external reference point (paragraphs 0023, 0075, 0077-0078, 0082, 0084, 0095, 0154, 0165-0166, 0169, 0231, 0275, and 0277 of Shim).
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 4, the combination teaches or suggests that the real-time data is position or movement data (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 5, the combination teaches or suggests that the device 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 data is pressure data (paragraphs 0015, 0018, 0026, 0035-0040, 0053, 0091, 0099, 0187, 0227, 0235-0237, and 0241 of Shim).
With respect to claim 7, the combination teaches or suggests that at least one of the plurality of the sensors 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 8, the combination teaches or suggests that the position and movement data comprises at least one of: magnetic, electromagnetic, microelectromechanical, radio frequency, ultrasound, and video data (paragraphs 0086-0087, 0227, and 0237 of Shim).
With respect to claim 9, the combination teaches or suggests that at least one of the plurality of sensors 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 10, the combination teaches or suggests that the device is inflatable (the inflatable component of Shim).
With respect to claim 11, the combination teaches or suggests that the device 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 13-20 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), and further in view of U.S. Patent Application Publication No. 2011/0077500 (Shakiba).
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 (paragraph 0274 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 device of Shim so as to assist in the proper execution of Kegel exercises so as to reap the expected benefits.
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 (1) that the method further comprises repeating steps (b) and (c) one or more times (the above 103 analysis)
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 the device of claim 1 (the above 103 analysis and rejection of claim 3; paragraphs 0003, 0024-0025, 0029, 0064-0065, 0111-0114, 0124-0127, 0137, 0160, and 0192 of Shim),
(b) displaying on a graphical user interface a visual representation of the subject’s vagina corresponding to a position of the device that is generated by the sensors prior to performance of a pelvic floor exercise, and recording the position that is prior to the performance (the above 103 analysis; 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);
(c) displaying on the graphical user interface a visual representation of the subject’s vagina corresponding to a position of the device that is generated by the sensors during the performance of the pelvic floor exercise by the subject, and recording the position that is during the performance (the above 103 analysis; 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);
(d) repeating steps (b) and (c) one or more times (the repetition analysis provided above); and
(e) generating pelvic floor position information based on the recorded positions of the subject’s vagina during steps (b) and (c) and using the pelvic floor position information to guide the subject via the visual representation during at least one step (c) so as to activate pelvic floor muscles that strengthen the pelvic floor or to limit activation of pelvic floor muscles that harm the pelvic floor, thereby treating the pelvic floor disorder (the guidance during the pelvic exercise suggested by Shim).
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 15, the combination teaches or suggests that the device transmits the positions of the subject’s vagina during steps (b) and (c) wirelessly to the graphical user interface (the wireless transmission of Shim to the graphical user interface suggested by Ghaffari; 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; the above 103 analysis; paragraphs 0023, 0075, 0077-0078, 0082, 0084, 0095, 0154, 0165-0166, 0169, 0231, 0248, 0251, 0275, and 0277 of Shim; abstract and paragraphs 0046, 0055-0056, 0061, 0067, and 0102 of Shakiba).
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 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/or (3) the method strengthens the pelvic floor muscles of the subject).
Alternatively, with respect to claim 18, the combination teaches or suggests that the method strengthens the 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 pelvic floor exercise comprises a Kegel maneuver or a Valsalva maneuver (the Kegel exercise of Shim).
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).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-10 of U.S. Patent No. 10,470,862 (the reference patent) in view of U.S. Patent Application Publication No. 2010/0174218 (Shim), in view of U.S. Patent Application Publication No. 2010/0298895 (Ghaffari).
Claim 1 of the reference patent includes a device comprising microelectromechanical accelerometers positioned along a length of the device. 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 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 (paragraphs 0015, 0018, 0026, 0035-0040, 0053, 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). It would have been obvious to one of ordinary skill in the art at the time of invention to use the microelectromechanical accelerometers with an inflatable component, as suggested by Shim, since a suitable mounting for the microelectromechanical accelerometers for a vaginal device is required and Shim teaches one such suitable mounting and/or it ensures contact with the vaginal wall.
The combination Shim does not explicitly disclose how the microelectromechanical accelerometers are physically interrelated to the inflatable component. Ghaffari teaches stretchable electronic circuits on inflatable surfaces made by printed (abstract and paragraphs 0010-0020, 0073-0084, 0090-0091, 0107, 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 microelectromechanical accelerometers with its accompanying wiring as a flexible printable circuit on the inflatable component since a method of incorporating the microelectromechanical accelerometers with the inflatable component is required and Ghaffari teaches one such method and/or it creates a more compact assembly.
Further, claim 1 of the reference patent includes generating pelvic floor position information based on the recorded positions of the patient’s vagina during steps (b) and (c) and using the pelvic floor position information to guide the patient via the visual representation during at least one step (c) which suggest real-time data monitoring and transmission.
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). 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 for display since it would make the device less cumbersome.
Claim 1 of the reference patent as modified includes all the features of claims 1-4, 10, and 12-13 of the present application.
Claim 5 of the reference patent as modified includes all the features of claims 5-6 of the present application.
Claim 2 of the reference patent as modified includes all the features of claims 14-15 of the present application.
Claim 3 of the reference patent as modified includes all the features of claim 16 of the present application.
Claim 4 of the reference patent as modified includes all the features of claim 17 of the present application.
Claim 7 of the reference patent as modified includes all the features of claim 18 of the present application.
Claim 8 or 9 of the reference patent as modified includes all the features of claim 19 of the present application.
Claim 10 of the reference patent as modified includes all the features of claim 20 of the present application.
With respect to claims 7-9 of the present application, 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, 0035-0041, 0086-0087, 0099, 0187, 0227, 0235-0237, and 0241 of Shim) and one or more additional sensors capable of providing real-time data selected from the group consisting of pressure, position, movement, pressure, and flow (paragraphs 0015, 0018, 0026, 0035-0041, 0053, 0086-0087, 0091, 0099, 0187, 0227, 0235-0237, and 0241 of Shim). It would have been obvious to add the additional sensors of Shim since it provides a fuller picture of the characteristics of the vagina.
With respect to claim 7 of the present application, claim 1 of the reference patent as modified includes that at least one of the plurality of the sensors 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 8 of the present application, claim 1 of the reference patent as modified includes that the position and movement data comprises at least one of: magnetic, electromagnetic, microelectromechanical, radio frequency, ultrasound, and video data (paragraphs 0086-0087, 0227, and 0237 of Shim).
With respect to claim 9 of the present application, claim 1 of the reference patent as modified includes that at least one of the plurality of sensors 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 of the present application, Shim teaches a plurality of inflatable compartments (paragraphs 0171 and 0252-0255 of Shim). It would have been obvious to include a plurality of inflatable compartments since it would provide a better fit for the vagina. Thus, claim 1 of the reference patent as modified includes all the features of claim 11.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791