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 May 11th, 2026, amended claims 1-4, 6, 8-12, 15-16, are 18-20 are entered. Claims 1-20 are currently pending and under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's arguments, filed on May 11th, 2026, with respect to the rejection under 35 U.S.C. 101 have been fully considered but they are not persuasive. The rejections are maintained, and further clarified, in view of the amendment.
At Pgs. 9-10 of the Reply, Applicant argues that “the present claims do not recite mental processes, which expressly exclude that which cannot practically be performed in the human mind”. Examiner respectfully disagrees.
The applicant has amended Claim 1 to include a limitations regarding measuring an orientation of the pressure sensor relative to a gravity vector and the orientation of the pressure sensor based on an angle formed between the gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the pressure sensor as newly recited steps that cannot practically be performed in the mind. Examiner would like to clarify that these steps are categorized as data-gathering, which is considered insignificant extra-solution activity.
The claims recite mental processes performed on a computer control system. The “Federal Circuit has explained, ‘[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.’ Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015).” MPEP 2106.04(a)(2) III. Thus, the use of the computing device does not prevent identification of the abstract idea as a mental process. There is no time limit recited for performing the steps. The claimed steps can be performed via pen and paper or in a person’s mind with no time limit. The computer is merely utilized as a tool to perform the mental steps.
The steps of processing, providing, and calibrating set forth a judicial exception. These steps describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea. The current claims do not have any limitations drawn to performing any decisions, procedures, or steps in response to the calibration. Therefore, there is nothing outside of the abstract idea that shows integration into practical application or significantly more.
At Pgs. 10-11 of the Reply, Applicant argues that “the present claims are nevertheless directed to patent eligible subject matter because the present claims integrate a practical application and amount to significantly more”. Examiner respectfully disagrees.
The claims are not integrated into a practical application because the abstract idea amounts to simply implementing the abstract idea on a computer. The claims do not apply the calibration to a particular machine and do not have any limitations drawn to performing any decisions, procedures, or steps in response to the calibrations. When considered in combination, the additional elements (i.e. the generic computing elements and sensors) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Thus, the claimed steps do not improve the functioning of the data acquisition or the signal exchange. “It is important to note, the judicial exception alone cannot provide the improvement.” MPEP 2106.05(a). The data acquisition and signal exchange appear to perform the same with or without the abstract idea. Therefore, any improvement resides solely within the abstract idea.
“The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification).” MPEP 2106.05(a). “That is, the claim must include the components or steps of the invention that provide the improvement described in the specification.” Id.
“[I]n McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea.” MPEP 2106.05 (a). There is no improvement to a computer or other technology. Unlike McRO, the claimed system invokes a computer as a tool to perform a mathematical concept and/or mental process.
The processor and units perform the same with or without the claimed abstract idea. Therefore, it is unclear how the abstract idea can improve the standard functions of the additional elements.
Furthermore, the Examiner is not asserting that the whole claim is an abstract idea. Rather, the Examiner is arguing that the abstract idea is only coupled with limitations that are insufficient in showing integration into practical application or amounting to significantly more than the abstract idea itself.
At Pgs. 11-12 of the Reply, Applicant argues that “the present claims are directed to patent eligible subject matter because the present claims are directed to a particular configuration of sensors and a particular method of using the raw data from the sensors”. Examiner respectfully disagrees.
The current application has no limitations regarding any “particular configuration of one or more sensors”. Rather, the claims merely recite a pressure sensor at least comprising an accelerometer, without any language regarding their placement or configuration. Thus, the claimed steps lack the specificity of those in Thales Visionx, Inc. v. United States (Fed. Cir. 2017). In this case, the computer is simply used as a tool; thus, the claims still recite mental processes performed on a computer control system. Therefore, the claims fail to be patent eligible for the same reasons the Court found the claims eligible in Thales Visionx, Inc. v. United States (Fed. Cir. 2017).
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objection
Claim 18 is objected to because of the following informality:
Claim 18 recites “muscles of the person” in line 7, but should read “muscles comprising the PFM of the person”
Appropriate correction is required.
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 computer-implemented method. 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. Claims 1-20 recite abstract ideas in the form of mental processes. 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 the abstract idea of: “processing by at least one computing device, first calibration measurements…processing, by the at least one computing device, second calibration measurements…providing, by the at least one computing device, at least one calibration model”.
Specifically, Claim 2 recites the abstract idea of: “processing, by at least one computing device, exercise measurements…calibrating, by the at least one computing device, the one or more pressure values of the processed exercise measurements at least based on the one or more orientation values of the processed exercise measurements”.
Specifically, Claim 20 recites the abstract idea of: “process exercise measurements taken by a pressure sensor positioned adjacent to a pelvic floor muscle (PFM) of a person…calibrate the pressure of the processed exercise measurements at least based on the orientation of the processed exercise measurements”.
The Examiner notes that the steps of measuring are considered data-gathering steps, which are considered insignificant extra-solution activity. 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, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “computing device”, “pressure sensor”, and “accelerometer” in independent Claim 1; “computing device”, “pressure sensor”, and “accelerometer” in independent Claim 2; “optical sensor” and “motion tracking device” in dependent Claim 17; “intra-body pressure sensor”, “accelerometer”, “computing device”, and “processor” in independent Claim 20 are generically recited elements in the claims which do not improve the functioning of a computer, or any other technology or technical field and/or serve as data-gathering elements. 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 implement the above-identified abstract idea (e.g., mental process) 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”, and “accelerometer” in independent Claim 1; “computing device”, “pressure sensor”, and “accelerometer” in independent Claim 2; “optical sensor” and “motion tracking device” in dependent Claim 17; “intra-body pressure sensor”, “accelerometer”, “computing device”, and “processor” 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 cited prior art and 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 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 § 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 1-3, 8-9, and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Xiamen Kosi Technology Co Ltd (CN110538432; cited by Applicant; machine translation (Google Patents), provided herewith, is referred to below) in view of Uehara (U.S. Patent No. 9,706,962).
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), the pressure sensor at least comprising a sensor to measure an orientation of the pressure sensor relative to a gravity vector (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22), and the first calibration measurements being representative of both: pressure exerted on the pressure sensor by muscles comprising the PFM 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 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 discloses a gravity sensor, Xiamen Kosi Technology Co Ltd fails to specifically teach an accelerometer; and wherein the orientation of the pressure sensor is based on an angle formed between the gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the pressure sensor.
In a similar technical field, Uehara teaches an apparatus and method for teaching and algorithms for identifying qualifying movements (Abstract), comprising an accelerometer (accelerometer 103), and wherein the orientation of the pressure sensor is based on an angle formed between the gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the pressure sensor (Gravity results in a constant acceleration vector toward the earth, creating a bias gravity component 133 in the accelerometer 103 output. The orientation calculation result may be utilized to identify the acceleration component in the direction of gravity. This component 103 in the direction of gravity may be subtracted from the accelerometer 103 output in order to remove the bias component due to gravity. This is shown in FIG. 2 as the subtraction 130 of the spatial orientation 131 output from the accelerometer 103 output. The result is spatial acceleration 135 or acceleration in three dimensions without the gravity component 133 of acceleration due to gravity. The spatial acceleration 135 result may be integrated 121 to calculate spatial velocity 137 or velocity in three dimensions. And finally, the spatial velocity 137 may be integrated 121 to determine the spatial position 139; Column 11 Line 61 – Column 12 Line 8).
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 accelerometer teachings of Uehara into the invention of Xiamen Kosi Technology Co Ltd in order to calculate spatial orientation and track movement while the user transitions between different movements (Uehara Column 13 Lines 46-67).
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 comprise one or more pressure values 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 one or more orientation values indicative of an orientation of the pressure sensor, the orientation of the pressure sensor measured by a sensor comprised in the pressure 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 one or more pressure values of the processed exercise measurements at least based on the one or more orientation values 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).
Although Xiamen Kosi Technology Co Ltd discloses a gravity sensor, Xiamen Kosi Technology Co Ltd fails to specifically teach an accelerometer, and wherein the orientation of the pressure sensor is based on an angle formed between a gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the pressure sensor.
In a similar technical field, Uehara teaches an apparatus and method for teaching and algorithms for identifying qualifying movements (Abstract), comprising an accelerometer (accelerometer 103), and wherein the orientation of the pressure sensor is based on an angle formed between a gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the pressure sensor (Gravity results in a constant acceleration vector toward the earth, creating a bias gravity component 133 in the accelerometer 103 output. The orientation calculation result may be utilized to identify the acceleration component in the direction of gravity. This component 103 in the direction of gravity may be subtracted from the accelerometer 103 output in order to remove the bias component due to gravity. This is shown in FIG. 2 as the subtraction 130 of the spatial orientation 131 output from the accelerometer 103 output. The result is spatial acceleration 135 or acceleration in three dimensions without the gravity component 133 of acceleration due to gravity. The spatial acceleration 135 result may be integrated 121 to calculate spatial velocity 137 or velocity in three dimensions. And finally, the spatial velocity 137 may be integrated 121 to determine the spatial position 139; Column 11 Line 61 – Column 12 Line 8).
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 accelerometer teachings of Uehara into the invention of Xiamen Kosi Technology Co Ltd in order to calculate spatial orientation and track movement while the user transitions between different movements (Uehara Column 13 Lines 46-67).
Regarding Claim 3, Xiamen Kosi Technology Co Ltd discloses wherein the one or more pressure values 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 of the PFM or 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, whether to repeat the physical exercise, or whether to 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 of lengthening, contracting, or relaxing of the PFM achieved by the person (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 the 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 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 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 a second PFM state based on the 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 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), the pressure sensor at least comprising a sensor (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22), 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) in 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 an accelerometer.
In a similar technical field, Uehara teaches an apparatus and method for teaching and algorithms for identifying qualifying movements (Abstract), comprising an accelerometer (accelerometer 103; Gravity results in a constant acceleration vector toward the earth, creating a bias gravity component 133 in the accelerometer 103 output. The orientation calculation result may be utilized to identify the acceleration component in the direction of gravity. This component 103 in the direction of gravity may be subtracted from the accelerometer 103 output in order to remove the bias component due to gravity. This is shown in FIG. 2 as the subtraction 130 of the spatial orientation 131 output from the accelerometer 103 output. The result is spatial acceleration 135 or acceleration in three dimensions without the gravity component 133 of acceleration due to gravity. The spatial acceleration 135 result may be integrated 121 to calculate spatial velocity 137 or velocity in three dimensions. And finally, the spatial velocity 137 may be integrated 121 to determine the spatial position 139; Column 11 Line 61 – Column 12 Line 8).
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 accelerometer teachings of Uehara into the invention of Xiamen Kosi Technology Co Ltd in order to calculate spatial orientation and track movement while the user transitions between different movements (Uehara Column 13 Lines 46-67).
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 first calibration measurements and the 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), the intra-body sensor comprising a sensor to measure an orientation of the intra-body pressure sensor relative to a gravity vector (gravity sensor 16); and
a computing device comprising a processor (main control unit 1232) operative to:
process exercise measurements taken by the intra-body 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 the 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 comprise one or more pressure values indicative of a pressure exerted on the intra-body pressure sensor (pressure measurement portion 12 is used for detecting the pressure of pelvic floor muscle; Page 8 Paragraph 22) and one or more orientation values indicative of the orientation of the intra-body pressure sensor (the gravity sensor 16 can detect the position change of the pressure measuring part 12; Page 8 Paragraph 22); and
calibrate the one or more pressure values of the processed exercise measurements at least based on the one or more orientation values 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).
Although Xiamen Kosi Technology Co Ltd discloses a gravity sensor, Xiamen Kosi Technology Co Ltd fails to specifically teach an accelerometer; and wherein the orientation of the intra-body pressure sensor based on an angle formed between the gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the intra-body pressure sensor.
In a similar technical field, Uehara teaches an apparatus and method for teaching and algorithms for identifying qualifying movements (Abstract), comprising an accelerometer (accelerometer 103); and wherein the orientation of the intra-body pressure sensor is based on an angle formed between the gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the intra-body pressure sensor (Gravity results in a constant acceleration vector toward the earth, creating a bias gravity component 133 in the accelerometer 103 output. The orientation calculation result may be utilized to identify the acceleration component in the direction of gravity. This component 103 in the direction of gravity may be subtracted from the accelerometer 103 output in order to remove the bias component due to gravity. This is shown in FIG. 2 as the subtraction 130 of the spatial orientation 131 output from the accelerometer 103 output. The result is spatial acceleration 135 or acceleration in three dimensions without the gravity component 133 of acceleration due to gravity. The spatial acceleration 135 result may be integrated 121 to calculate spatial velocity 137 or velocity in three dimensions. And finally, the spatial velocity 137 may be integrated 121 to determine the spatial position 139; Column 11 Line 61 – Column 12 Line 8).
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 accelerometer teachings of Uehara into the invention of Xiamen Kosi Technology Co Ltd in order to calculate spatial orientation and track movement while the user transitions between different movements (Uehara Column 13 Lines 46-67).
Claims 2-3, 5-8, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Egorov et al (U.S. Publication No. 2012/259247; cited by Applicant) in view of Uehara (U.S. Patent No. 9,706,962).
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 comprise one or more pressure values indicative of a pressure exerted on the pressure sensor and one or more orientation values indicative of an orientation of the pressure 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]), the orientation of the pressure sensor measured by an accelerometer comprised in 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; [0031-0037]); and
calibrating, by the at least one computing device, the one or more pressure values of the processed exercise measurements at least based on the one or more orientation values 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]).
Although Egorov discloses a pressure sensor array and a motion tracking sensor, Egorov fails to specifically teach wherein the orientation of the pressure sensor is based on an angle formed between a gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the pressure sensor.
In a similar technical field, Uehara teaches an apparatus and method for teaching and algorithms for identifying qualifying movements (Abstract), wherein the orientation of the pressure sensor is based on an angle formed between a gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the pressure sensor (Gravity results in a constant acceleration vector toward the earth, creating a bias gravity component 133 in the accelerometer 103 output. The orientation calculation result may be utilized to identify the acceleration component in the direction of gravity. This component 103 in the direction of gravity may be subtracted from the accelerometer 103 output in order to remove the bias component due to gravity. This is shown in FIG. 2 as the subtraction 130 of the spatial orientation 131 output from the accelerometer 103 output. The result is spatial acceleration 135 or acceleration in three dimensions without the gravity component 133 of acceleration due to gravity. The spatial acceleration 135 result may be integrated 121 to calculate spatial velocity 137 or velocity in three dimensions. And finally, the spatial velocity 137 may be integrated 121 to determine the spatial position 139; Column 11 Line 61 – Column 12 Line 8).
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 accelerometer teachings of Uehara into the invention of Egorov in order to calculate spatial orientation and track movement while the user transitions between different movements (Uehara Column 13 Lines 46-67).
Regarding Claim 3, Egorov discloses wherein the one or more pressure values 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 multi-personal 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 of the PFM or 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 one or more pressure values of the processed exercise measurements are calibrated when the one or more orientation values of the processed exercise measurements are 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]), the intra-body pressure sensor comprising an accelerometer to measure an orientation of the intra-body 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; [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 the intra-body pressure sensor positioned adjacent to a pelvic floor muscle (PFM) of the 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 comprise one or more pressure values indicative of a pressure exerted on the intra-body pressure sensor and one or more orientation values indicative of the orientation of the intra-body 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 one or more pressure values of the processed exercise measurements at least based on the one or more orientation values 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]).
Although Egorov discloses a motion tracking sensor, Egorov fails to specifically teach wherein the orientation is measured relative to a gravity vector; and wherein the orientation of the intra-body pressure sensor based on an angle formed between the gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the intra-body pressure sensor.
In a similar technical field, Uehara teaches an apparatus and method for teaching and algorithms for identifying qualifying movements (Abstract), wherein the orientation is measured relative to a gravity vector; and wherein the orientation of the intra-body pressure sensor based on an angle formed between the gravity vector and a lengthwise axis, a widthwise axis, or a vertical axis of the intra-body pressure sensor (Gravity results in a constant acceleration vector toward the earth, creating a bias gravity component 133 in the accelerometer 103 output. The orientation calculation result may be utilized to identify the acceleration component in the direction of gravity. This component 103 in the direction of gravity may be subtracted from the accelerometer 103 output in order to remove the bias component due to gravity. This is shown in FIG. 2 as the subtraction 130 of the spatial orientation 131 output from the accelerometer 103 output. The result is spatial acceleration 135 or acceleration in three dimensions without the gravity component 133 of acceleration due to gravity. The spatial acceleration 135 result may be integrated 121 to calculate spatial velocity 137 or velocity in three dimensions. And finally, the spatial velocity 137 may be integrated 121 to determine the spatial position 139; Column 11 Line 61 – Column 12 Line 8).
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 accelerometer teachings of Uehara into the invention of Egorov in order to calculate spatial orientation and track movement while the user transitions between different movements (Uehara Column 13 Lines 46-67).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Xiamen Kosi Technology Co Ltd and Uehara as applied to claim 3 above, and further in view of Beer et al (U.S. Publication No. 2021/069513; cited by Applicant).
Regarding Claim 4, Xiamen Kosi Technology Co Ltd and Uehara fail 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 those of Xiamen Kosi Technology Co Ltd and Uehara 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 and Uehara as applied to claim 3 above, and further in view of Beer et al.
Regarding Claim 4, Egorov and Uehara fail 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 those of Egorov and Uehara 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHANEL J YOON/Examiner, Art Unit 3791
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