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 .
Amendment Entered
In response to the amendment filed on November 17th, 2025, amended claim 18 is entered. Claims 1-20 are currently pending and under examination.
Election/Restrictions
Applicant's arguments, with respect to the restriction, filed on November 17th, 2025, have been fully considered and are persuasive. The Restriction Requirement, filed on September 19th, 2025, has been withdrawn. Group I (Claim 1) and Group III (Claim 20) have been re-instated and will be considered under examination, in addition to elected Group II (Claims 2-19).
Claim Objections
Claims 1, 4, 6, 12, 16, and 18 are objected to because of the following informalities:
Claim 1 recites “muscle, PFM, of” in line 4, but should read “muscle (PFM) of”
Claim 1 recites “sensor each” in line 8, but should read “sensor in each”
Claim 4 recites “regression or” in line 3, but should read “regression, or”
Claim 6 recites “multipersonal” in line 3, but should read “multi-personal”
Claim 12 recites “by at least” in line 2, but should read “by the at least”
Claim 16 recites “comprising” in line 1, but should read “comprising:”
Claim 18 recites “sensor each” in line 8, but should read “sensor in each”
Claim 18 recites “measurements” in line 19, but should read “measurements.”
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 “muscles of the person” in line 7. It is unclear as to whether these “muscles” are meant to include the previously introduced “pelvic floor muscle”, or if these “muscles” are referring to a separate element.
Claim 2 recites “the sensor” in line 5. It is unclear as to whether this limitation is supposed to be referring to the previously introduced “pressure sensor” from lines 2-3 of Claim 2, or a separate element.
Claim 2 recites the limitation "the pressure of the processed exercise measurements" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear as to whether this limitation is referring to the “pressure exerted on the pressure sensor” previously introduced in lines 4-5 of Claim 2, or a separate element.
Claim 2 recites the limitation "the orientation of the processed exercise measurements" in line 7. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear as to whether this limitation is referring to the “orientation of the sensor” previously introduced in line 5 of Claim 2, or a separate element.
Claim 8 recites “at least one of” in line 2. Further in line 2, Claim 8 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if both limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 9 recites “whether the physical exercise has been executed or to repeat or continue the physical exercise” in lines 6-7. It is unclear as to exactly what this limitation entails, as it could be interpreted in multiple ways. The limitation could be interpreted as offering three different options: #1) physical exercise has been executed, #2) repeat the physical exercise, or #3) continue the physical exercise. The limitation could also be interpreted as offering two different options: #1) physical exercise has been executed, or #2) repeat or continue the physical exercise. It is unclear as to which interpretation the Applicant intended. Further, it is unclear as to whether there is a difference between “repeating” the physical exercise and “continuing” the physical exercise. Clarification is requested.
Claim 10 recites “an orientation of the processed exercise measurements” in line 2. It is unclear as to whether this limitation is referring to the “orientation of the sensor” previously introduced in line 5 of Claim 2, "the orientation of the processed exercise measurements" in line 7 of Claim 2, or a separate element.
Claim 11 recites “a level with which the PFM has been in one or more of a plurality of different PFM states” in lines 6-7. It is unclear as to what exactly this limitation entails, as it is unclear what “level” means in this case. Clarification is requested.
Claim 12 recites the limitation "the processed first and second calibration measurements" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites “first and second calibration measurements” in line 2. It is unclear as to whether this limitation is referring to “the processed first and second calibration measurements” previously introduced in Claim 12, or a separate element.
Claim 15 recites the limitation "the second PFM state" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites “muscles of the person” in line 8. It is unclear as to whether these “muscles” are meant to include the previously introduced “pelvic floor muscle” of Claim 2 and “PFM” recited earlier in Claim 18, or if these “muscles” are referring to a separate element.
Claim 18 recites the limitation "the relationship" in line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites “a person” in line 6. It is unclear as to whether this limitation is supposed to be referring to the previously introduced “person” from line 2 of Claim 20, or a separate element.
Claim 20 recites “a pressure sensor” in line 5. It is unclear as to whether this limitation is supposed to be referring to the previously introduced “intra-body pressure sensor” from line 2 of Claim 20, or a separate element. Similarly, Claim 20 later recites “the pressure sensor” in lines 7-8. It is further unclear as to whether this limitation is supposed to be referring to the “intra-body pressure sensor” from line 2 of Claim 20, “pressure sensor” from line 5 of Claim 20, or a separate element.
Claim 20 recites “the sensor” in line 8. It is unclear as to whether this limitation is supposed to be referring to the previously introduced “intra-body pressure sensor” from line 2 of Claim 20, “pressure sensor” from line 5 of Claim 20, “pressure sensor” from lines 7-8 of Claim 20, or a separate element.
Claim 20 recites the limitation "the pressure of the processed exercise measurements" in line 9. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear as to whether this limitation is referring to the “pressure exerted on the pressure sensor” previously introduced in lines 7-8 of Claim 20, or a separate element.
Claim 20 recites the limitation "the orientation of the processed exercise measurements" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear as to whether this limitation is referring to the “orientation of the sensor” previously introduced in line 8 of Claim 20, or a separate element.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1-19 recite a series of steps or acts for calibration of pelvic floor muscle measurements. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
Claim 20 recites a system for tracking pelvic floor muscle exercises. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1-20 recites at least one step or instruction for calibration of pelvic floor muscle measurements which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Claims 1-20 recite abstract ideas in the form of mental processes, as consistent with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Processing and calibrating exercise measurements may be performed by a human. Accordingly, each of Claims 1-20 recites an abstract idea.
Specifically, Claim 1 recites:
processing, by at least one computing device, first calibration measurements taken while a person has a first set of predetermined calibration positions such that, in each position of the first set, a pelvic floor muscle, PFM, of the person is in a first PFM state, the first calibration measurements being taken by a pressure sensor arranged inside the person adjacent to the PFM, the pressure sensor at least comprising an accelerometer, and the first calibration measurements being representative of both: pressure exerted on the pressure sensor by muscles of the person and an orientation of the pressure sensor each position of the first set;
processing, by the at least one computing device, second calibration measurements taken while the person has a second set of predetermined calibration positions such that, in each position of the second set, the PFM is in a second PFM state, the second calibration measurements being taken by the pressure sensor arranged inside the person adjacent to the PFM, and the second calibration measurements being representative of both: the pressure exerted on the pressure sensor by the muscles of the person and the orientation of the pressure sensor in each position of the second set; and
providing, by the at least one computing device, at least one calibration model that relates the pressure exerted on the pressure sensor by the muscles of the person to the orientations of the pressure sensor based on the processed first and second calibration measurements.
Specifically, Claim 2 recites:
processing, by at least one computing device, exercise measurements taken by a pressure sensor positioned adjacent to a pelvic floor muscle (PFM) of a person at least during performance of a physical exercise, wherein the exercise measurements are indicative of a pressure exerted on the pressure sensor and an orientation of the sensor; and
calibrating, by the at least one computing device, the pressure of the processed exercise measurements at least based on the orientation of the processed exercise measurements.
Specifically, Claim 20 recites:
an intra-body pressure sensor adapted for introduction into a vagina or an anus of a person; and
a computing device comprising a processor operative to:
process exercise measurements taken by a pressure sensor positioned adjacent to a pelvic floor muscle (PFM) of a person at least during performance of a physical exercise, wherein the exercise measurements are indicative of a pressure exerted on the pressure sensor and an orientation of the sensor; and
calibrate the pressure of the processed exercise measurements at least based on the orientation of the processed exercise measurements.
Further, dependent Claims 3-19 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1, 2, and 20 (and dependent Claims 3-19) is not integrated into a practical application under 2019 PEG because the additional elements (identified in bold above in independent Claims 1, 2, and 20), either alone or in combination, generally link the use of the above-identified abstract idea (underlined above in independent Claims 1, 2, and 20) to a particular technological environment or field of use. More specifically, the additional elements of: “computing device”, “pressure sensor”, “accelerometer” in independent Claim 1; “computing device”, “pressure sensor” in independent Claim 2; “optical sensor”, “motion tracking device” in dependent Claim 17; “accelerometer” in dependent Claim 18; “intra-body pressure sensor”, “computing device”, “processor”, “pressure sensor” in independent Claim 20 are generically recited elements in independent Claims 1, 2, and 20 (and dependent Claims 3-19) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1, 2, and 20 (and dependent Claims 3-19) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., “computing device” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 2, and 20 (and dependent Claims 3-19) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 2, and 20 (and dependent Claims 3-19) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-20 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “computing device”, “pressure sensor”, “accelerometer” in independent Claim 1; “computing device”, “pressure sensor” in independent Claim 2; “optical sensor”, “motion tracking device” in dependent Claim 17; “accelerometer” in dependent Claim 18; “intra-body pressure sensor”, “computing device”, “processor”, “pressure sensor” in independent Claim 20.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks and/or used for data-gathering (insignificant extra-solution activity). The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g. paragraphs [0112-0121]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. processing and calibrating) and the additional elements perform generic data-gathering steps that are well-understood, routine, and conventional activities previously known to the pertinent industry;
Applicant’s Background in the specification; and
The non-patent literature of record in the application.
Accordingly, in light of Applicant’s specification, the claimed term “computing device” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “computing device”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the methods and system of Claims 1-20 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-20 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 2, and 20 (and dependent Claims 3-19) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2-3, 8-9, 11-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiamen Kosi Technology Co Ltd (CN110538432; cited by Applicant; machine translation (Google Patents), provided herewith, is referred to below).
Regarding Claim 2, Xiamen Kosi Technology Co Ltd discloses a computer-implemented method (Training method and system of portable pelvic floor muscle training device; Abstract) comprising:
processing, by at least one computing device (main control unit 1232), exercise measurements taken by a pressure sensor (pressure measuring portion 12 includes…pressure sensing module 123; Page 8 Paragraphs 22-24) positioned adjacent to a pelvic floor muscle (PFM) of a person at least during performance of a physical exercise (pressure measurement portion 12 is used for detecting the pressure of pelvic floor muscle on same position…the portable pelvic floor muscle training device 1 is particularly suitable for home users, can enable the users to use and train the pelvic floor muscles independently, is convenient for the users to use and carry, and improves the convenience of products; Page 8 Paragraphs 22-23; Figures 12-13), wherein the exercise measurements are indicative of a pressure exerted on the pressure sensor (pressure measurement portion 12 is used for detecting the pressure of pelvic floor muscle; Page 8 Paragraph 22) and an orientation of the sensor (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22); and
calibrating, by the at least one computing device, the pressure of the processed exercise measurements at least based on the orientation of the processed exercise measurements (It can be understood that, in step S112a and step S122a, pressure detection is performed on the pelvic floor muscle based on the obtained portable pelvic floor muscle training device, and when an initial pressure value is obtained, an error caused by self pressure due to self gravity of the portable pelvic floor muscle training device is deducted through calculation, so that accuracy of the pressure detection is further improved, evaluation level of the pelvic floor muscle of the user is more accurate, and efficiency of pelvic floor muscle training is further improved; Page 5 Paragraph 28; the gravity sensor 16 can detect the position change of the pressure measuring part 12, and the pressure detected by the pressure measuring part 12 can be corrected based on the position change; Page 8 Paragraph 22; the gravity sensor 16 sends position information corresponding to each value sensed by the pressure sensor 1231 to the main control unit 1232, and the main control unit 1232 converts the value and the position information into pressure and transmits the pressure to an external device. It can be understood that the top rod 121 can rotate relative to the fixing portion 122, so that when the top rod 121 is at a standstill, the top rod 121 can have a pressure effect on the pressure sensor 1231 due to the gravity of the top rod 121, so that a value of the pressure when the pressure sensor detects the pressure is larger, and since the top rod 121 has different pressures on the pressure sensor 1231 at different positions, the pressure value of the pressure sensor 1231 needs to be corrected for the top rod 121 at different positions, so as to improve the accuracy of the pelvic floor muscle pressure detection; Page 9 Paragraphs 6-7).
Regarding Claim 3, Xiamen Kosi Technology Co Ltd discloses wherein the pressure of the processed exercise measurements are calibrated using at least one calibration model that comprises a relationship between the pressure and the orientation of the pressure sensor (the gravity sensor 16 can detect the position change of the pressure measuring part 12, and the pressure detected by the pressure measuring part 12 can be corrected based on the position change; Page 8 Paragraph 22; the gravity sensor 16 sends position information corresponding to each value sensed by the pressure sensor 1231 to the main control unit 1232, and the main control unit 1232 converts the value and the position information into pressure and transmits the pressure to an external device. It can be understood that the top rod 121 can rotate relative to the fixing portion 122, so that when the top rod 121 is at a standstill, the top rod 121 can have a pressure effect on the pressure sensor 1231 due to the gravity of the top rod 121, so that a value of the pressure when the pressure sensor detects the pressure is larger, and since the top rod 121 has different pressures on the pressure sensor 1231 at different positions, the pressure value of the pressure sensor 1231 needs to be corrected for the top rod 121 at different positions, so as to improve the accuracy of the pelvic floor muscle pressure detection; Page 9 Paragraphs 6-7).
Regarding Claim 8, Xiamen Kosi Technology Co Ltd discloses wherein the physical exercise comprises at least one of lengthening and contracting of the PFM (a training method of a portable pelvic floor muscle training device comprises the following steps: step S1: acquiring at least one systolic pressure of the pelvic floor muscles, and acquiring at least one evaluation grade of the pelvic floor muscles based on the systolic pressure and a plurality of preset thresholds; step S2: transmitting the contraction pressure…step S12 a: acquiring a second pressure of the pelvic floor muscle in a contraction state; Page 3 Paragraphs 1-2).
Regarding Claim 9, Xiamen Kosi Technology Co Ltd discloses determining, by the at least one computing device, whether the physical exercise has been executed based on whether the calibrated pressure of the processed exercise measurements fulfill at least one exercise requirement (step S1: acquiring at least one systolic pressure of the pelvic floor muscles, and acquiring at least one evaluation grade of the pelvic floor muscles based on the systolic pressure and a plurality of preset thresholds; Page 3 Paragraph 1); and
providing, by the at least one computing device, one or more instructions or signals indicative of whether the physical exercise has been executed or to repeat or continue the physical exercise (step S2: transmitting the contraction pressure and the evaluation grade to at least one display device, and displaying the contraction pressure and the evaluation grade by the display device in real time; and step S3: and acquiring a training method matched with the evaluation grade based on the at least one evaluation grade; Page 3 Paragraph 1).
Regarding Claim 11, Xiamen Kosi Technology Co Ltd discloses wherein calibrating the pressure of the processed exercise measurements comprises: providing one or more calibration values associated with the at least one calibration model (Step S13 a: and calculating a difference value between the second pressure and the first pressure, and matching the difference value with a first preset threshold value in the plurality of preset threshold values to obtain a first evaluation grade of the pelvic floor muscle; Page 5 Paragraph 8); and
comparing the pressure of the processed exercise measurements with the one or more calibration values to determine a level with which the PFM has been in one or more of a plurality of different PFM states (It can be understood that, in step S13a, by calculating the difference between the second pressure and the first pressure to obtain the systolic pressure of the pelvic floor muscle, the error of the calculation of the systolic pressure by the pressure of the pelvic floor muscle in the relaxed state is reduced, and the accuracy of the pressure detection is improved. It is to be understood that, in step S13a, if the difference is set to be P, the first preset threshold includes: 1) Excellent (grade 5): p > 70g/cm2 2) Good (grade 4): 70g/cm2> P > -50 g/cm2 3) medium (grade 3): 50g/cm2> P > -40 g/cm2 4) poor (grade 2): 40g/cm2> P > -30 g/cm2 5) Poor (grade 1): 30g/cm2> P > -10 g/cm2 6) Range (grade 0): 10g/cm2> P By matching the difference between the second pressure and the first pressure with the first preset threshold value to grade the systolic pressure of the pelvic floor muscles, so that the user can view a more intuitive muscle strength evaluation, the first evaluation level may correspond to one of the preset threshold values (e.g., excellent, good, or moderate); Page 5 Paragraphs 12-20).
Regarding Claim 12, Xiamen Kosi Technology Co Ltd discloses processing, by at least one computing device, calibration measurements taken during one or more calibration positions corresponding to one or more different PFM states (a training method of a portable pelvic floor muscle training device comprises the following steps: step S1: acquiring at least one systolic pressure of the pelvic floor muscles, and acquiring at least one evaluation grade of the pelvic floor muscles based on the systolic pressure and a plurality of preset thresholds; step S2: transmitting the contraction pressure…the step S1 specifically includes the following steps: step S11 a: acquiring a first pressure of pelvic floor muscles in a relaxed state; step S12 a: acquiring a second pressure of the pelvic floor muscle in a contraction state; Page 3 Paragraphs 1-2); and
providing, by the at least one computing device, the at least one calibration model based at least on the processed first and second calibration measurements (the gravity sensor 16 can detect the position change of the pressure measuring part 12, and the pressure detected by the pressure measuring part 12 can be corrected based on the position change; Page 8 Paragraph 22; the gravity sensor 16 sends position information corresponding to each value sensed by the pressure sensor 1231 to the main control unit 1232, and the main control unit 1232 converts the value and the position information into pressure and transmits the pressure to an external device. It can be understood that the top rod 121 can rotate relative to the fixing portion 122, so that when the top rod 121 is at a standstill, the top rod 121 can have a pressure effect on the pressure sensor 1231 due to the gravity of the top rod 121, so that a value of the pressure when the pressure sensor detects the pressure is larger, and since the top rod 121 has different pressures on the pressure sensor 1231 at different positions, the pressure value of the pressure sensor 1231 needs to be corrected for the top rod 121 at different positions, so as to improve the accuracy of the pelvic floor muscle pressure detection; Page 9 Paragraphs 6-7).
Regarding Claim 13, Xiamen Kosi Technology Co Ltd discloses wherein the calibration measurements comprise first and second calibration measurements comprising pressure and orientation measurements taken by the pressure sensor arranged adjacent to the PFM of the person during first and second calibration positions, respectively (the step S1 specifically includes the following steps: step S11 a: acquiring a first pressure of pelvic floor muscles in a relaxed state; step S12 a: acquiring a second pressure of the pelvic floor muscle in a contraction state; and step S13 a: and calculating a difference value between the second pressure and the first pressure, and matching the difference value with a first preset threshold value in the plurality of preset threshold values to obtain a first evaluation grade of the pelvic floor muscle. Preferably, the step S11a specifically includes the following steps: step S111 a: acquiring a portable pelvic floor muscle training device, wherein the portable pelvic floor muscle training device is used for being placed in a female vagina to detect the contraction pressure of pelvic floor muscles; step S112 a: acquiring initial relaxing pressure of pelvic floor muscles in a relaxing state based on the portable pelvic floor muscle training device, acquiring first self pressure corresponding to the portable pelvic floor muscle training device under the initial relaxing pressure, and acquiring the first pressure; and the step S12a specifically includes the following steps: step S121 a: acquiring initial contraction pressure of pelvic floor muscles in a contraction state based on the portable pelvic floor muscle training device; step S122 a: and acquiring a second pressure based on the initial contraction pressure and a second self pressure corresponding to the portable pelvic floor muscle training device under the initial contraction pressure. Preferably, the first pressure and the second pressure are obtained based on the same position detection in the pelvic floor muscle; Page 3 Paragraphs 2-4).
Regarding Claim 14, Xiamen Kosi Technology Co Ltd discloses processing, by the at least one computing device, third calibration measurements taken during at least one first calibration position corresponding to a first PFM state, wherein the at least one calibration model is further based at least on the processed third calibration measurements (the step S1 specifically includes the following steps: step S11 b: acquiring third pressure of pelvic floor muscles in a contraction state, and acquiring duration time corresponding to the third pressure; and step S12 b: determining a second evaluation level of the pelvic floor muscle based on the duration matching the difference with a second preset threshold of the plurality of preset thresholds. Preferably, the step S1 specifically includes the following steps: step S11 c: acquiring the contraction times of the pelvic floor muscle in the preset time; and step S12 c: determining a third evaluation level of the pelvic floor muscle based on the number of contractions matching a third preset threshold of the plurality of preset thresholds; Page 3 Paragraphs 5-6).
Regarding Claim 15, Xiamen Kosi Technology Co Ltd discloses wherein the at least one calibration model comprises: a first calibration model for a first PFM state based on the processed first calibration measurements (step S112 a: acquiring initial relaxing pressure of pelvic floor muscles in a relaxing state based on the portable pelvic floor muscle training device, acquiring first self pressure corresponding to the portable pelvic floor muscle training device under the initial relaxing pressure, and acquiring the first pressure; Page 3 Paragraph 3); and
a second calibration model for the second PFM state based on the processed second calibration measurements (step S12a specifically includes the following steps: step S121 a: acquiring initial contraction pressure of pelvic floor muscles in a contraction state based on the portable pelvic floor muscle training device; step S122 a: and acquiring a second pressure based on the initial contraction pressure and a second self pressure corresponding to the portable pelvic floor muscle training device under the initial contraction pressure; Page 3 Paragraph 3).
Regarding Claim 16, Xiamen Kosi Technology Co Ltd discloses providing, by the at least one computing device, one or more instructions or signals indicative of each position of the one or more calibration positions (With continued reference to fig. 7, the training method in step S3 may further perform visual training in conjunction with the display device. For example, in this embodiment, by displaying a game screen on a display device, the game content is designed to perform a breakthrough based on the pelvic muscle pressure to control the action (e.g., walking or jumping) of the character, and the game content can control the vagina to adapt to a certain dynamics curve track to perform contraction and relaxation according to the fourth training method; Page 8 Paragraph 4).
Regarding Claim 17, Xiamen Kosi Technology Co Ltd discloses processing, by the at least one computing device, verification measurements taken during the one or more calibration positions by at least one optical sensor positioned to capture an image or video of at least a portion of the person or at least one motion tracking device arranged on the person (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22); and wherein the at least one calibration model is provided when the processed verification measurements are indicative of the person having been in each position of the one or more calibration positions (the gravity sensor 16 can detect the position change of the pressure measuring part 12, and the pressure detected by the pressure measuring part 12 can be corrected based on the position change; Page 8 Paragraph 22; after the pelvic floor muscle contracts, the vaginal wall surface is urged to compress the push rod 121, the push rod 121 rotates, so that one end of the push rod 121 approaches the fixing part 122 to press the pressure sensing module 123, and the contraction pressure of the pelvic floor muscle at this time can be detected based on the pressure sensing module 123; Page 9 Paragraph 4; the gravity sensor 16 sends position information corresponding to each value sensed by the pressure sensor 1231 to the main control unit 1232, and the main control unit 1232 converts the value and the position information into pressure and transmits the pressure to an external device. It can be understood that the top rod 121 can rotate relative to the fixing portion 122, so that when the top rod 121 is at a standstill, the top rod 121 can have a pressure effect on the pressure sensor 1231 due to the gravity of the top rod 121, so that a value of the pressure when the pressure sensor detects the pressure is larger, and since the top rod 121 has different pressures on the pressure sensor 1231 at different positions, the pressure value of the pressure sensor 1231 needs to be corrected for the top rod 121 at different positions, so as to improve the accuracy of the pelvic floor muscle pressure detection; Page 9 Paragraphs 6-7).
Regarding Claim 19, Xiamen Kosi Technology Co Ltd discloses wherein the at least one calibration model consists of a single calibration model when the at least one computing device determines a correlation between the processed first calibration measurements and the processed second calibration measurements that exceeds a predetermined correlation threshold (It can be understood that, in step S13a, by calculating the difference between the second pressure and the first pressure to obtain the systolic pressure of the pelvic floor muscle, the error of the calculation of the systolic pressure by the pressure of the pelvic floor muscle in the relaxed state is reduced, and the accuracy of the pressure detection is improved. It is to be understood that, in step S13a, if the difference is set to be P, the first preset threshold includes: 1) Excellent (grade 5): p > 70g/cm2 2) Good (grade 4): 70g/cm2> P > -50 g/cm2 3) medium (grade 3): 50g/cm2> P > -40 g/cm2 4) poor (grade 2): 40g/cm2> P > -30 g/cm2 5) Poor (grade 1): 30g/cm2> P > -10 g/cm2 6) Range (grade 0): 10g/cm2> P By matching the difference between the second pressure and the first pressure with the first preset threshold value to grade the systolic pressure of the pelvic floor muscles, so that the user can view a more intuitive muscle strength evaluation, the first evaluation level may correspond to one of the preset threshold values (e.g., excellent, good, or moderate); Page 5 Paragraphs 12-20).
Regarding Claim 20, Xiamen Kosi Technology Co Ltd discloses a system for tracking pelvic floor muscle (PFM) exercises (Training method and system of portable pelvic floor muscle training device; Abstract), comprising:
an intra-body pressure sensor adapted for introduction into a vagina or an anus of a person (a portable pelvic floor muscle training device 1 for placement in a woman's vagina to detect the systolic pressure of the pelvic floor muscles…pressure measuring portion 12 includes…pressure sensing module 123; Page 8 Paragraphs 22-24); and
a computing device comprising a processor (main control unit 1232) operative to:
process exercise measurements taken by a pressure sensor (pressure measuring portion 12 includes…pressure sensing module 123; Page 8 Paragraphs 22-24) positioned adjacent to a pelvic floor muscle (PFM) of a person at least during performance of a physical exercise (pressure measurement portion 12 is used for detecting the pressure of pelvic floor muscle on same position…the portable pelvic floor muscle training device 1 is particularly suitable for home users, can enable the users to use and train the pelvic floor muscles independently, is convenient for the users to use and carry, and improves the convenience of products; Page 8 Paragraphs 22-23; Figures 12-13), wherein the exercise measurements are indicative of a pressure exerted on the pressure sensor (pressure measurement portion 12 is used for detecting the pressure of pelvic floor muscle; Page 8 Paragraph 22) and an orientation of the sensor (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22); and
calibrate the pressure of the processed exercise measurements at least based on the orientation of the processed exercise measurements (It can be understood that, in step S112a and step S122a, pressure detection is performed on the pelvic floor muscle based on the obtained portable pelvic floor muscle training device, and when an initial pressure value is obtained, an error caused by self pressure due to self gravity of the portable pelvic floor muscle training device is deducted through calculation, so that accuracy of the pressure detection is further improved, evaluation level of the pelvic floor muscle of the user is more accurate, and efficiency of pelvic floor muscle training is further improved; Page 5 Paragraph 28; the gravity sensor 16 can detect the position change of the pressure measuring part 12, and the pressure detected by the pressure measuring part 12 can be corrected based on the position change; Page 8 Paragraph 22; the gravity sensor 16 sends position information corresponding to each value sensed by the pressure sensor 1231 to the main control unit 1232, and the main control unit 1232 converts the value and the position information into pressure and transmits the pressure to an external device. It can be understood that the top rod 121 can rotate relative to the fixing portion 122, so that when the top rod 121 is at a standstill, the top rod 121 can have a pressure effect on the pressure sensor 1231 due to the gravity of the top rod 121, so that a value of the pressure when the pressure sensor detects the pressure is larger, and since the top rod 121 has different pressures on the pressure sensor 1231 at different positions, the pressure value of the pressure sensor 1231 needs to be corrected for the top rod 121 at different positions, so as to improve the accuracy of the pelvic floor muscle pressure detection; Page 9 Paragraphs 6-7).
Claims 2-3, 5-8, 10, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Egorov et al (U.S. Publication No. 2012/259247; cited by Applicant).
Regarding Claim 2, Egorov discloses a computer-implemented method (Methods for assessment of improvements in pelvic organ conditions after an interventional procedure; Abstract) comprising:
processing, by at least one computing device (an electronic unit for data acquisition may be configured to record the pressure array readings and the motion sensor readings, so that in combination, the sensor coordinates and sensor pressure data are recorded at the same time and paired together for placing into 3-D tactile image; [0031]), exercise measurements taken by a pressure sensor positioned adjacent to a pelvic floor muscle (PFM) of a person (The transvaginal probe 10 includes one or multiple pressure sensors forming one or multiple pressure sensor arrays configured for contacting vaginal walls and cervix; [0031]) at least during performance of a physical exercise (the transvaginal probe 10 may be used for detecting muscle strength under a vaginal muscular contraction when a patient is instructed to contract appropriate vaginal muscles; [0030]), wherein the exercise measurements are indicative of a pressure exerted on the pressure sensor and an orientation of the sensor (Pressure sensor array 14 may be configured for a contact with cervix 18. The pressure sensor arrays may be assembled as two-dimensional sensor arrays on the part of the surface of the probe 10 adapted for contacting the vaginal tissue. The pressure-sensitive surface of the probe 10 configured for contacting the vaginal wall may have a rounded shape with a radius of curvature of about 15 mm. The pressure-sensitive surface of the pressure sensor array 14 may be flat. The motion tracking sensor 15 may be configured to record at least one or more of the three coordinates (X, Y, Z) and/or three angles (Elevation, Rotation, Azimuth) of the transvaginal probe 10; [0031]); and
calibrating, by the at least one computing device, the pressure of the processed exercise measurements at least based on the orientation of the processed exercise measurements (Recording coordinates and angles allows calculating coordinates of all pressure sensors of the probe 10 in a coordinate system tied to pelvic floor bony framework. An electronic unit for data acquisition may be configured to record the pressure array readings and the motion sensor readings, so that in combination, the sensor coordinates and sensor pressure data are recorded at the same time and paired together for placing into 3-D tactile image…the spatial mapping technique involves acquisition of probe motion tracking data, which may be transformed into spatial coordinates of each pressure sensor at the contact surface of the vaginal wall where the pressure signals were acquired during in the course of vaginal wall deformation…calculated tissue elasticity and geometrical measures may be projected on the respective cross-section of the 3-D tactile image to assist in visual interpretation of the examination results and comparison with reference data. Reference data may include prior measurements for the same patient or normal elasticity distributions and normal anatomical sizes obtained for a plurality of patients with known clinical status. Clinical examples of vaginal tactile images are presented in FIG. 2 and FIG. 3; [0031-0032]).
Regarding Claim 3, Egorov discloses wherein the pressure of the processed exercise measurements are calibrated using at least one calibration model that comprises a relationship between the pressure and the orientation of the pressure sensor (The motion tracking sensor 15 may be configured to record at least one or more of the three coordinates (X, Y, Z) and/or three angles (Elevation, Rotation, Azimuth) of the transvaginal probe 10. Recording coordinates and angles allows calculating coordinates of all pressure sensors of the probe 10 in a coordinate system tied to pelvic floor bony framework. An electronic unit for data acquisition may be configured to record the pressure array readings and the motion sensor readings, so that in combination, the sensor coordinates and sensor pressure data are recorded at the same time and paired together for placing into 3-D tactile image…the spatial mapping technique involves acquisition of probe motion tracking data, which may be transformed into spatial coordinates of each pressure sensor at the contact surface of the vaginal wall where the pressure signals were acquired during in the course of vaginal wall deformation…calculated tissue elasticity and geometrical measures may be projected on the respective cross-section of the 3-D tactile image to assist in visual interpretation of the examination results and comparison with reference data. Reference data may include prior measurements for the same patient or normal elasticity distributions and normal anatomical sizes obtained for a plurality of patients with known clinical status. Clinical examples of vaginal tactile images are presented in FIG. 2 and FIG. 3; [0031-0037]).
Regarding Claim 5, Egorov discloses wherein the at least one calibration model comprises at least one multi-personal calibration model that relates pressure measurements to orientations of the pressure sensor based on calibration measurements collected for predetermined calibration positions for a plurality of calibration subjects (Calculated tissue elasticity and geometrical measures may be projected on the respective cross-section of the 3-D tactile image to assist in visual interpretation of the examination results and comparison with reference data. Reference data may include prior measurements for the same patient or normal elasticity distributions and normal anatomical sizes obtained for a plurality of patients with known clinical status. Clinical examples of vaginal tactile images are presented in FIG. 2 and FIG. 3; [0032]; The values of thresholds may be defined from clinical data for a plurality of patients, in particular, for patients with known clinical diagnosis established by different modalities…elevated risk of POP development is detected if the spacing profile exceeds these thresholds; [0044]).
Regarding Claim 6, Egorov discloses receiving or providing the at least one multi-personal calibration model; and modifying the at least one multipersonal calibration model based on one or more factors indicative of a maximum pressure of the PFM in different states (The spatial mapping technique involves acquisition of probe motion tracking data, which may be transformed into spatial coordinates of each pressure sensor at the contact surface of the vaginal wall where the pressure signals were acquired during in the course of vaginal wall deformation…Calculated tissue elasticity and geometrical measures may be projected on the respective cross-section of the 3-D tactile image to assist in visual interpretation of the examination results and comparison with reference data. Reference data may include prior measurements for the same patient or normal elasticity distributions and normal anatomical sizes obtained for a plurality of patients with known clinical status. Clinical examples of vaginal tactile images are presented in FIG. 2 and FIG. 3; [0032]; Early warning of the impending prolapse can therefore be obtained by recording the tactile image of the vaginal tissues and detecting the change in elasticity as compared to a predefined normal threshold…(e) estimating a risk of POP development by comparing at least one elasticity modulus profile at the two or more locations against respective predetermined elasticity modulus thresholds for the same locations as well as by comparing the spacing profile against respective predetermined distance thresholds; [0042-0043]; The values of thresholds may be defined from clinical data for a plurality of patients, in particular, for patients with known clinical diagnosis established by different modalities. The locations for comparing elasticity modulus may be selected to include distal anterior, distal posterior, middle anterior and middle posterior sections of vagina. These locations are known to closely correspond with the pelvic floor support structure. The locations for comparing distances between the anterior and posterior vaginal walls may be selected to include proximal, middle and distal sections of vagina…comparison of spacing profile may be done against the distance thresholds of about 15 mm for middle section and about 25 mm for distal section of the vagina respectively. Elevated risk of POP development is detected if the spacing profile exceeds these thresholds. [0045] In embodiments, the step of estimating the risk of POP development may also include an adjustment based on at least one or more patient-specific factors. Such patient-specific factors may include patient's age, history of childbirth, history of chronic straining to empty bowel or bladder, status of menopause, obesity, history of prior hysterectomy, history of prior pelvic surgery, history of strenuous activity, smoking status, and alcohol use status; [0044-0046]; (e) estimating extent of pelvic support tissue impairment or damage after childbirth by comparing at least one or more elasticity modulus profiles against normal values such as for example corresponding elasticity modulus profile or profiles obtained for patients known to have no pelvic support tissue impairment or damage. The extent of tissue impairment or damage may be further estimated by comparing at least one or more of the calculated spacing profiles against normal values, for example against a corresponding spacing profile obtained for patients known to have no pelvic support tissue impairment or damage; [0048]).
Regarding Claim 7, Egorov discloses wherein the at least one multi- personal calibration model is further calibrated based on additional sensor measurements collected from the person (sensor arrays 12 and 13 may be configured for a contact with opposing vaginal walls, e.g. anterior wall 16 and posterior wall 17, as well as a left side and a right side of vagina 11. Pressure sensor array 14 may be configured for a contact with cervix 18. The pressure sensor arrays may be assembled as two-dimensional sensor arrays on the part of the surface of the probe 10 adapted for contacting the vaginal tissue. The pressure-sensitive surface of the probe 10 configured for contacting the vaginal wall may have a rounded shape with a radius of curvature of about 15 mm. The pressure-sensitive surface of the pressure sensor array 14 may be flat. The motion tracking sensor 15 may be configured to record at least one or more of the three coordinates (X, Y, Z) and/or three angles (Elevation, Rotation, Azimuth) of the transvaginal probe 10. Recording coordinates and angles allows calculating coordinates of all pressure sensors of the probe 10 in a coordinate system tied to pelvic floor bony framework. An electronic unit for data acquisition may be configured to record the pressure array readings and the motion sensor readings, so that in combination, the sensor coordinates and sensor pressure data are recorded at the same time and paired together for placing into 3-D tactile image; [0031]; the step of estimating the risk of POP development may also include an adjustment based on at least one or more patient-specific factors. Such patient-specific factors may include patient's age, history of childbirth, history of chronic straining to empty bowel or bladder, status of menopause, obesity, history of prior hysterectomy, history of prior pelvic surgery, history of strenuous activity, smoking status, and alcohol use status; [0045]).
Regarding Claim 8, Egorov discloses wherein the physical exercise comprises at least one of lengthening and contracting of the PFM (the transvaginal probe 10 may be used for detecting muscle strength under a vaginal muscular contraction when a patient is instructed to contract appropriate vaginal muscles; [0030]).
Regarding Claim 10, Egorov discloses wherein the pressure of the processed exercise measurements is calibrated when an orientation of the processed exercise measurements is within a predetermined orientation range (FIG. 5 is an exemplary illustration of calculating spacing profile for the anterior-posterior vaginal walls…For characterization of anatomical conditions of the vagina and its support structures, a set of locations and spacing threshold values for these locations may be introduced, e.g. for proximal, middle and distal sections of vagina; [0041]; The step of calculating a spacing profile may further include calculating vaginal wall coordinates along the vagina at the constant pressure level of about 1 kPa so as to establish physical locations (boundaries) of the vaginal walls at rest; [0044]).
Regarding Claim 20, Egorov discloses a system for tracking pelvic floor muscle (PFM) exercises (Methods for assessment of improvements in pelvic organ conditions after an interventional procedure; Abstract), comprising:
an intra-body pressure sensor adapted for introduction into a vagina or an anus of a person (The transvaginal probe 10 includes one or multiple pressure sensors forming one or multiple pressure sensor arrays configured for contacting vaginal walls and cervix; [0031]); and
a computing device comprising a processor (an electronic unit for data acquisition may be configured to record the pressure array readings and the motion sensor readings, so that in combination, the sensor coordinates and sensor pressure data are recorded at the same time and paired together for placing into 3-D tactile image; [0031]) operative to:
process exercise measurements taken by a pressure sensor positioned adjacent to a pelvic floor muscle (PFM) of a person at least during performance of a physical exercise (the transvaginal probe 10 may be used for detecting muscle strength under a vaginal muscular contraction when a patient is instructed to contract appropriate vaginal muscles; [0030]), wherein the exercise measurements are indicative of a pressure exerted on the pressure sensor and an orientation of the sensor (Pressure sensor array 14 may be configured for a contact with cervix 18. The pressure sensor arrays may be assembled as two-dimensional sensor arrays on the part of the surface of the probe 10 adapted for contacting the vaginal tissue. The pressure-sensitive surface of the probe 10 configured for contacting the vaginal wall may have a rounded shape with a radius of curvature of about 15 mm. The pressure-sensitive surface of the pressure sensor array 14 may be flat. The motion tracking sensor 15 may be configured to record at least one or more of the three coordinates (X, Y, Z) and/or three angles (Elevation, Rotation, Azimuth) of the transvaginal probe 10; [0031]); and
calibrate the pressure of the processed exercise measurements at least based on the orientation of the processed exercise measurements (Recording coordinates and angles allows calculating coordinates of all pressure sensors of the probe 10 in a coordinate system tied to pelvic floor bony framework. An electronic unit for data acquisition may be configured to record the pressure array readings and the motion sensor readings, so that in combination, the sensor coordinates and sensor pressure data are recorded at the same time and paired together for placing into 3-D tactile image…the spatial mapping technique involves acquisition of probe motion tracking data, which may be transformed into spatial coordinates of each pressure sensor at the contact surface of the vaginal wall where the pressure signals were acquired during in the course of vaginal wall deformation…calculated tissue elasticity and geometrical measures may be projected on the respective cross-section of the 3-D tactile image to assist in visual interpretation of the examination results and comparison with reference data. Reference data may include prior measurements for the same patient or normal elasticity distributions and normal anatomical sizes obtained for a plurality of patients with known clinical status. Clinical examples of vaginal tactile images are presented in FIG. 2 and FIG. 3; [0031-0032]).
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.
Claims 1 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Xiamen Kosi Technology Co Ltd in view of Egorov.
Regarding Claim 1, Xiamen Kosi Technology Co Ltd discloses a computer-implemented method (Training method and system of portable pelvic floor muscle training device; Abstract), comprising:
processing, by at least one computing device (main control unit 1232), first calibration measurements taken while a person has a first set of predetermined calibration positions such that, in each position of the first set, a pelvic floor muscle, PFM, of the person is in a first PFM state (step S112 a: acquiring initial relaxing pressure of pelvic floor muscles in a relaxing state; Page 3 Paragraph 3), the first calibration measurements being taken by a pressure sensor arranged inside the person adjacent to the PFM (a portable pelvic floor muscle training device 1 for placement in a woman's vagina to detect the systolic pressure of the pelvic floor muscles…pressure measuring portion 12 includes…pressure sensing module 123; Page 8 Paragraphs 22-24), and the first calibration measurements being representative of both: pressure exerted on the pressure sensor by muscles of the person (pressure measurement portion 12 is used for detecting the pressure of pelvic floor muscle; Page 8 Paragraph 22) and an orientation of the pressure sensor (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22) each position of the first set (step S112 a: acquiring initial relaxing pressure of pelvic floor muscles in a relaxing state based on the portable pelvic floor muscle training device, acquiring first self pressure corresponding to the portable pelvic floor muscle training device under the initial relaxing pressure, and acquiring the first pressure; Page 3 Paragraphs 2-4);
processing, by the at least one computing device (main control unit 1232), second calibration measurements taken while the person has a second set of predetermined calibration positions such that, in each position of the second set, the PFM is in a second PFM state (step S121 a: acquiring initial contraction pressure of pelvic floor muscles in a contraction state; Page 3 Paragraph 3), the second calibration measurements being taken by the pressure sensor arranged inside the person adjacent to the PFM (a portable pelvic floor muscle training device 1 for placement in a woman's vagina to detect the systolic pressure of the pelvic floor muscles…pressure measuring portion 12 includes…pressure sensing module 123; Page 8 Paragraphs 22-24), and the second calibration measurements being representative of both: the pressure exerted on the pressure sensor by the muscles of the person (pressure measurement portion 12 is used for detecting the pressure of pelvic floor muscle; Page 8 Paragraph 22) and the orientation of the pressure sensor (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22) in each position of the second set (step S12a specifically includes the following steps: step S121 a: acquiring initial contraction pressure of pelvic floor muscles in a contraction state based on the portable pelvic floor muscle training device; step S122 a: and acquiring a second pressure based on the initial contraction pressure and a second self pressure corresponding to the portable pelvic floor muscle training device under the initial contraction pressure; Page 3 Paragraphs 2-4); and
providing, by the at least one computing device (main control unit 1232), at least one calibration model that relates the pressure exerted on the pressure sensor by the muscles of the person to the orientations of the pressure sensor based on the processed first and second calibration measurements (It can be understood that, in step S112a and step S122a, pressure detection is performed on the pelvic floor muscle based on the obtained portable pelvic floor muscle training device, and when an initial pressure value is obtained, an error caused by self pressure due to self gravity of the portable pelvic floor muscle training device is deducted through calculation, so that accuracy of the pressure detection is further improved, evaluation level of the pelvic floor muscle of the user is more accurate, and efficiency of pelvic floor muscle training is further improved; Page 5 Paragraph 28; the gravity sensor 16 can detect the position change of the pressure measuring part 12, and the pressure detected by the pressure measuring part 12 can be corrected based on the position change; Page 8 Paragraph 22; the gravity sensor 16 sends position information corresponding to each value sensed by the pressure sensor 1231 to the main control unit 1232, and the main control unit 1232 converts the value and the position information into pressure and transmits the pressure to an external device. It can be understood that the top rod 121 can rotate relative to the fixing portion 122, so that when the top rod 121 is at a standstill, the top rod 121 can have a pressure effect on the pressure sensor 1231 due to the gravity of the top rod 121, so that a value of the pressure when the pressure sensor detects the pressure is larger, and since the top rod 121 has different pressures on the pressure sensor 1231 at different positions, the pressure value of the pressure sensor 1231 needs to be corrected for the top rod 121 at different positions, so as to improve the accuracy of the pelvic floor muscle pressure detection; Page 9 Paragraphs 6-7).
Although Xiamen Kosi Technology Co Ltd teaches a gravity sensor, Xiamen Kosi Technology Co Ltd fails to specifically teach wherein the pressure sensor at least comprises an accelerometer.
In a similar technical field, Egorov teaches methods for assessment of improvements in pelvic organ conditions after an interventional procedure (Abstract) wherein the pressure sensor (the transvaginal probe 10 may be used for detecting muscle strength under a vaginal muscular contraction when a patient is instructed to contract appropriate vaginal muscles…the transvaginal probe 10 includes one or multiple pressure sensors forming one or multiple pressure sensor arrays configured for contacting vaginal walls and cervix; [0030-0031]) at least comprises an accelerometer (The motion tracking sensor 15 may be configured to record at least one or more of the three coordinates (X, Y, Z) and/or three angles (Elevation, Rotation, Azimuth) of the transvaginal probe 10; [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the motion tracking sensor teachings of Egorov into the invention of Xiamen Kosi Technology Co Ltd in order to calculate three-dimensional coordinates of all pressure sensors of the probe in a coordinate system tied to pelvic floor bony framework (Egorov [0031]).
Regarding Claim 18, Xiamen Kosi Technology Co Ltd discloses processing, by the at least one computing device (main control unit 1232), first calibration measurements taken while the person has a first set of predetermined calibration positions such that, in each position of the first set, the PFM of the person is in a first PFM state (step S112 a: acquiring initial relaxing pressure of pelvic floor muscles in a relaxing state; Page 3 Paragraph 3), the first calibration measurements being taken by the pressure sensor positioned adjacent to the PFM (a portable pelvic floor muscle training device 1 for placement in a woman's vagina to detect the systolic pressure of the pelvic floor muscles…pressure measuring portion 12 includes…pressure sensing module 123; Page 8 Paragraphs 22-24), and the first calibration measurements being representative of both: pressure exerted on the pressure sensor by muscles of the person (pressure measurement portion 12 is used for detecting the pressure of pelvic floor muscle; Page 8 Paragraph 22) and the orientation of the pressure sensor (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22) each position of the first set of predetermined calibration positions (step S112 a: acquiring initial relaxing pressure of pelvic floor muscles in a relaxing state based on the portable pelvic floor muscle training device, acquiring first self pressure corresponding to the portable pelvic floor muscle training device under the initial relaxing pressure, and acquiring the first pressure; Page 3 Paragraphs 2-4);
processing, by the at least one computing device (main control unit 1232), second calibration measurements taken while the person has a second set of predetermined calibration positions such that, in each position of the second set of predetermined calibration positions, the PFM is in a second PFM state (step S121 a: acquiring initial contraction pressure of pelvic floor muscles in a contraction state; Page 3 Paragraph 3), the second calibration measurements being taken by the pressure sensor positioned adjacent to the PFM (a portable pelvic floor muscle training device 1 for placement in a woman's vagina to detect the systolic pressure of the pelvic floor muscles…pressure measuring portion 12 includes…pressure sensing module 123; Page 8 Paragraphs 22-24), and the second calibration measurements being representative of both: the pressure exerted on the pressure sensor by the muscles of the person (pressure measurement portion 12 is used for detecting the pressure of pelvic floor muscle; Page 8 Paragraph 22) and the orientation of the pressure sensor (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22) in each position of the second set of predetermined calibration positions (step S12a specifically includes the following steps: step S121 a: acquiring initial contraction pressure of pelvic floor muscles in a contraction state based on the portable pelvic floor muscle training device; step S122 a: and acquiring a second pressure based on the initial contraction pressure and a second self pressure corresponding to the portable pelvic floor muscle training device under the initial contraction pressure; Page 3 Paragraphs 2-4); and
providing, by the at least one computing device (main control unit 1232), at least one calibration model that comprises the relationship between the pressure and the orientation of the pressure sensor based on the first calibration measurements and the second calibration measurements (It can be understood that, in step S112a and step S122a, pressure detection is performed on the pelvic floor muscle based on the obtained portable pelvic floor muscle training device, and when an initial pressure value is obtained, an error caused by self pressure due to self gravity of the portable pelvic floor muscle training device is deducted through calculation, so that accuracy of the pressure detection is further improved, evaluation level of the pelvic floor muscle of the user is more accurate, and efficiency of pelvic floor muscle training is further improved; Page 5 Paragraph 28; the gravity sensor 16 can detect the position change of the pressure measuring part 12, and the pressure detected by the pressure measuring part 12 can be corrected based on the position change; Page 8 Paragraph 22; the gravity sensor 16 sends position information corresponding to each value sensed by the pressure sensor 1231 to the main control unit 1232, and the main control unit 1232 converts the value and the position information into pressure and transmits the pressure to an external device. It can be understood that the top rod 121 can rotate relative to the fixing portion 122, so that when the top rod 121 is at a standstill, the top rod 121 can have a pressure effect on the pressure sensor 1231 due to the gravity of the top rod 121, so that a value of the pressure when the pressure sensor detects the pressure is larger, and since the top rod 121 has different pressures on the pressure sensor 1231 at different positions, the pressure value of the pressure sensor 1231 needs to be corrected for the top rod 121 at different positions, so as to improve the accuracy of the pelvic floor muscle pressure detection; Page 9 Paragraphs 6-7).
Although Xiamen Kosi Technology Co Ltd teaches a gravity sensor, Xiamen Kosi Technology Co Ltd fails to specifically teach wherein the pressure sensor at least comprises an accelerometer.
In a similar technical field, Egorov teaches methods for assessment of improvements in pelvic organ conditions after an interventional procedure (Abstract) wherein the pressure sensor (the transvaginal probe 10 may be used for detecting muscle strength under a vaginal muscular contraction when a patient is instructed to contract appropriate vaginal muscles…the transvaginal probe 10 includes one or multiple pressure sensors forming one or multiple pressure sensor arrays configured for contacting vaginal walls and cervix; [0030-0031]) at least comprises an accelerometer (The motion tracking sensor 15 may be configured to record at least one or more of the three coordinates (X, Y, Z) and/or three angles (Elevation, Rotation, Azimuth) of the transvaginal probe 10; [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the motion tracking sensor teachings of Egorov into the invention of Xiamen Kosi Technology Co Ltd in order to calculate three-dimensional coordinates of all pressure sensors of the probe in a coordinate system tied to pelvic floor bony framework (Egorov [0031]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Xiamen Kosi Technology Co Ltd in view of Beer et al (U.S. Publication No. 2021/069513; cited by Applicant).
Regarding Claim 4, Xiamen Kosi Technology Co Ltd fails to teach wherein the at least one calibration model is based on one or more of a linear regression, quadratic regression, logistic regression or machine learning-based algorithm.
In a similar technical field, Beer teaches intravaginal devices and electrical stimulation devices, systems, thereof, and methods of using the devices and systems thereof to observe pelvic floor movements (Abstract), wherein the at least one calibration model (the term “calibration period” refers to the process of determining a baseline set of measurements from the sensors positioned within the intravaginal device during a period of use of the intravaginal device by an individual, such that the baseline set of measurements characterize the health (e.g., strength, muscle quality, condition) of the individual's pelvic floor muscles prior to or at the start of a treatment program. The baseline set of measurements collected during the calibration period can be used to calculate and/or determine the progress of an individual through a treatment program; [0020]; The user may also be prompted to insert and calibrate her intravaginal device using the Calibration and Orientation screen. The Calibration and Orientation screen will coach the user through inserting and orienting the intravaginal device; [0136-0138]; [0159]) is based on one or more of a linear regression, quadratic regression, logistic regression or machine learning-based algorithm (As certain sensors yield differential signal to noise ratios for different subjects due to different internal anatomies and vaginal lengths, the algorithm and composite scores can be optimized for each subject…the peripheral device or microcontroller may use artificial intelligence and machine learning to optimize its algorithms for optimal detection of an occurrence of an event (e.g., pelvic floor movement); [0186]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the machine learning-based algorithm teachings of Beer into the invention of Xiamen Kosi Technology Co Ltd in order to optimize the algorithm and composite scores for each subject, as certain sensors yield differential signal to noise ratios for different subjects due to different internal anatomies and vaginal lengths (Beer [0186]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Egorov in view of Beer et al.
Regarding Claim 4, Egorov fails to teach wherein the at least one calibration model is based on one or more of a linear regression, quadratic regression, logistic regression or machine learning-based algorithm.
In a similar technical field, Beer teaches intravaginal devices and electrical stimulation devices, systems, thereof, and methods of using the devices and systems thereof to observe pelvic floor movements (Abstract), wherein the at least one calibration model (the term “calibration period” refers to the process of determining a baseline set of measurements from the sensors positioned within the intravaginal device during a period of use of the intravaginal device by an individual, such that the baseline set of measurements characterize the health (e.g., strength, muscle quality, condition) of the individual's pelvic floor muscles prior to or at the start of a treatment program. The baseline set of measurements collected during the calibration period can be used to calculate and/or determine the progress of an individual through a treatment program; [0020]; The user may also be prompted to insert and calibrate her intravaginal device using the Calibration and Orientation screen. The Calibration and Orientation screen will coach the user through inserting and orienting the intravaginal device; [0136-0138]; [0159]) is based on one or more of a linear regression, quadratic regression, logistic regression or machine learning-based algorithm (As certain sensors yield differential signal to noise ratios for different subjects due to different internal anatomies and vaginal lengths, the algorithm and composite scores can be optimized for each subject…the peripheral device or microcontroller may use artificial intelligence and machine learning to optimize its algorithms for optimal detection of an occurrence of an event (e.g., pelvic floor movement); [0186]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the machine learning-based algorithm teachings of Beer into the invention of Egorov in order to optimize the algorithm and composite scores for each subject, as certain sensors yield differential signal to noise ratios for different subjects due to different internal anatomies and vaginal lengths (Beer [0186]).
Conclusion
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/CHANEL J JHIN/Examiner, Art Unit 3791