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 .
Priority
Acknowledgement is made to the instant applications status as a 371 of PCT/US22/81818 filed 12/16/2022, and which claims priority to provisional application 63/290,435 filed 12/16/2021. Therefore the earliest date of priority of 12/16/2021 is granted to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/17/2024, and 09/27/2024 have been considered by the examiner.
Claim Objections
Claim 3 is objected to because of the following informalities:
On line 14 “at least part” should be –at least in part--.
Claim 53 is objected to because of the following informalities:
On line 13 “at least part” should be –at least in part--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “one or more input devices configured to enable the subject to provide responses to the motions executed by the motion platform”, and “one or more feedback devices configured to provide the subject with feedback indicative of whether the responses are correct or incorrect” in independent claims 1 and 51.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
In regards to the one or more input devices, paragraph [0041] the instant application states “In some embodiments, the one or more input devices 120 may include one or more handheld devices configured to enable the subject to provide the responses to the motions executed by the motion platform 110. In some embodiments, the one or more handheld devices may include a plurality of buttons 150 configured to enable the subject to provide different types of the responses to the motions executed by the motion platform 110.”
In regards to the one or more feedback devices, paragraph [0041] states “In some embodiments, the one or more feedback devices 130 may be configured to provide the subject with auditory feedback indicative of whether the responses are correct or incorrect. In some embodiments, the one or more feedback devices 130 may be configured to provide the subject with visual feedback indicative of whether the responses are correct or incorrect.”
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4,9-10,14-15,18,32-33,38,42,45,48-49, and 51-54 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation ““one or more feedback devices configured to provide the subject with feedback indicative of whether the responses are correct or incorrect” in independent claims 1 and 51 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no definition in the specification detailing what the applicant is considering a feedback device, and the drawings only show a basic block diagram with reference numeral 130 to denote that they are the feedback devices in figure 7. Any structure capable of providing any form of feedback could be considered the feedback device of the invention based on the sections of the specification which discuss the claimed limitations, as noted above in the claim interpretation. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 4 recites the limitation “wherein the controller is further configured to: determine that one of the additional responses is indicative of a lapse by the subject” on lines 1-3. There is no definition provided in the specification as to what “a lapse” by the subject is meant to be. The examiner notes that throughout the specification an exemplary algorithm to determine which response can be considered a lapse is discussed, but not what a lapse indicative response is, or what the applicant is considering a lapse.
In addition on lines 5-6, claim 4 recites the limitation “while excluding the one of the additional responses indicative of a lapse by the subject.” As stated above there is no definition provided in the specification as to what “a lapse” by the subject is meant to be. The examiner notes that throughout the specification an exemplary algorithm to determine which response can be considered a lapse is discussed, but not what a lapse indicative response is, or what the applicant is considering a lapse.
Claim 33 recites the limitation “ at or near the previously determined threshold” on line 2. There is no definition for what the applicant is considering near a threshold, and therefore it is unclear what the metes and bounds of the claimed limitation are.
Claim 54 recites the limitation “determining that one of the additional responses is indicative of a lapse by the subject” on line 2. There is no definition provided in the specification as to what “a lapse” by the subject is meant to be. The examiner notes that throughout the specification an exemplary algorithm to determine which response can be considered a lapse is discussed, but not what a lapse indicative response is, or what the applicant is considering a lapse.
Furthermore, on lines 5-6 claim 54 recites “while excluding the one of the additional responses indicative of a lapse by the subject.” As stated above there is no definition provided in the specification as to what “a lapse” by the subject is meant to be. The examiner notes that throughout the specification an exemplary algorithm to determine which response can be considered a lapse is discussed, but not what a lapse indicative response is, or what the applicant is considering a lapse.
Dependent claims 2-3, 9-10,14-15,18,32-33,38,42,45,48-49, and 52-53 are rejected due to their dependency on a rejected base claim.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2,38,42,45,48-49, and 51-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merfeld et al. US 20190015035 A1 in view of Briel US 20210236903 A1.
Regarding claim 1:
Merfeld teaches a vestibular training device for improving vestibular function and balance and reducing fall risk of a subject (“This disclosure relates to vestibular testing systems and methods.” See paragraph [0003]), the vestibular training device comprising: a motion platform (motion platform 110) configured to support the subject thereon and to execute a set of discrete motions (“During operation, the motion platform 110 supports the subject 150 and the controller 120 can provide a stimulus signal to the motion platform 110 for movement.” See paragraph [0006]); one or more input devices (input device 130) configured to enable the subject to provide responses to the motions executed by the motion platform (“During operation, the subject 150 provides an input to the input device 130 to communicate his or her perception of motion to the processor 140.” See paragraph [0076]); and a controller (The examiner notes that the system of Merfeld includes both a controller 120 and a processor 140 which together control the system overall) in communication with the motion platform (“The controller 120 can instruct (e.g., by providing stimuli signals) a predefined set of motions to the motion platform.” See paragraph [0081]), the one or more input devices, and the one or more feedback devices (“Alternatively, the controller 120 can instruct the motion platform based on the input received by the input device 130. For example, the processor 140 is configured to instruct the controller 120 to cause execution of those motions for which expected information about a subject's perception of those motions would most contribute to improving an estimate of a subject's vestibular threshold.” See paragraph [0081] and figure 14), wherein the controller is configured to: cause the motion platform to execute a first motion (See above citation of paragraph [0081]); receive, via the one or more input devices, a first response indicative of the subject's perception of the first motion (“During operation, the subject 150 provides an input to the input device 130 to communicate his or her perception of motion to the processor 140.” See paragraph [0076]); and determine a second motion based at least in part on the first response (See above citation of paragraph [0081] where the user’s response to the motion cause the processor to instruct the controller what the next motion needs to be for the training session); and cause the motion platform to execute the second motion (See above citation of paragraph [0081]).
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Merfeld fails to teach one or more feedback devices configured to provide the subject with feedback indicative of whether the responses are correct or incorrect; and that the controller causes the one or more feedback devices to provide first feedback indicative of whether the first response is correct or incorrect.
The examiner notes that due to the indefinite nature of the claim language, see 35 USC 112(b) rejections above, it must be mentioned that during trail phases of the training in Merfeld, as stated in paragraph [0100] that users were informed whether their responses to the perception of motion were correct or incorrect, implying that there was some feedback device capable of notifying the user, however it is not stated what structure or form this feedback device is in, or if it is connected to the controller of the system in any way.
Briel, however, teaches machines, systems, and methods for coordinated total body and brain exercise, specifically a stationary device adapted for cycling that is also equipped with a punch receiving surface with indicators for sequencing and coordinating punch repetition(s) (See abstract) and further teaches one or more feedback devices configured to provide the subject with feedback indicative of whether the responses are correct or incorrect (The examiner notes that due to the unclear nature of the claim language, see 35 USC 112(b) rejection above, the claimed limitation is being interpreted under the broadest reasonable interpretation with no further structural or functional limitations as anything capable of providing feedback to the user, and therefore the visual display 32 is a feedback device); cause the one or more feedback devices to provide first feedback indicative of whether the first response is correct or incorrect (“At a high level, the punch-and-cycle device is directed to detecting a punch to a target zone by a sensor unit, signaling a controller by the sensor unit in response to the step of detecting, and controlling the result (e.g. correct or incorrect) displayed by the target zone with regards to the accuracy and/or reaction time of the punch so delivered. For example, the target zone may illuminate in a different color or shape to indicate either a correct or incorrect punch.” See paragraph [0078]).
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It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Merfeld to include a feedback device which indicates correct or incorrect responses as taught by Briel, as this allows the user to be corrected as they perform training with the system allowing them to progress faster by being able to receive an indication of whether their choices were correct or incorrect without needing a coach or trainer, and without needing to stop exercise to receive a report of the training.
Regarding claim 2:
Merfeld as modified by Briel teaches the vestibular training device of claim 1, wherein the controller is further configured to: receive, via the one or more input devices, a second response indicative of the subject's perception of the second motion (“As described above, the input device 130 can receive both the binary response and the confidence rating for a given motion, in other words, for each trial.” See paragraph [0080] of Merfeld. The examiner notes that the system is capable of a plurality of motions as noted in the rejection above for claim 1, and it can receive inputs for the binary response for each motion also noted above in the rejection of claim 1, and therefore simply adding motions and input requests is the same steps and structures merely repeated for each trial.); cause the one or more feedback devices to provide second feedback indicative of whether the second response is correct or incorrect (As noted above in the rejection of claim 1, the display will provide a response indicating a correct or incorrect input for each attempt at answering) ; determine a third motion based at least in part on the second response (as noted above in the rejection of claim 1, specifically paragraph [0081] of Merfeld the controller can use the inputs to determine what the motion should be for each trial); and cause the motion platform to execute the third motion (See above citation of paragraph [0081] of Merfeld which is repeated for each trial).
Regarding claim 32:
Merfeld as modified discloses the vestibular training device of claim 1, wherein the discrete motions are individually tailored for the subject based at least in part on a previously determined threshold for the subject (“For example, the motions can be selected for those motions for which expected information about the subject's perception of those motions would most contribute to improving an estimate of a subject's vestibular threshold.” See paragraph [0082]. The examiner notes that paragraph [0081] does discuss the creation of vestibulograms for each subject which show the vestibular threshold for each subject at different frequencies of motion, creating a previously determined threshold).
Regarding claim 33:
Merfeld as modified discloses the vestibular training device of claim 32, wherein the discrete motions are individually tailored for the subject to be at or near the previously determined threshold for the subject (Due to the unclear nature of the claim language, see 35 USC 112(b) rejection above, the system tailoring the motions based on the previously determined thresholds with the aim of improving/testing vestibular function without the express aim to cause the user to fail, implies that the motions are tailored at least at or near the threshold data in order for the user to perform training sessions).
Regarding claim 38:
Merfeld as modified discloses the vestibular training device of claim 1, wherein the discrete motions are incrementally changed over the course of a training session (“Specifically, we used a 3-Down/1-Up (3D/1U) staircase having a hundred trials. The simulated 3D/1U staircases began at a stimulus level of four. The size of the change in stimulus magnitude was determined using PEST (parameter estimation by sequential testing) rules.” See paragraph [0103]. The examiner notes that the sequential staircase stimulus requires incremental changes over the course of the training session to function).
Regarding claim 42:
Merfeld as modified discloses the vestibular training device of claim 1, wherein the one or more input devices comprise one or more handheld devices configured to enable the subject to provide the responses to the motions executed by the motion platform (“FIG. 16A shows an example of an input device 130, which includes a pair of buttons 132 and 134. Other examples of input device 130 include a joystick, pair of joysticks, a keyboard, a pair of switches, or foot pedals. After a motion of the motion platform 110, the subject 150 can press one of the buttons 132 and 134 to indicate his or her perception.” See paragraph [0076], with paragraph [0077] further stating “FIG. 16B shows another example of an input device 130, which can be a touch screen such as a tablet device or a keyboard, e.g., a numeric keypad.”, which the examiner notes tablets, handheld buttons, joysticks, and switches can all be handheld, even a keyboard if a user decides to hold it while training)).
Regarding claim 45:
Merfeld as modified by Briel teaches the vestibular training device of claim 1, wherein the one or more feedback devices are configured to provide the subject with auditory and/or visual feedback indicative of whether the responses are correct or incorrect (See rejection of claim 1).
Regarding claim 48:
Merfeld as modified by Briel teaches the vestibular training device of claim 1, further comprising noise- cancelling headphones (“Each subject wore a pair of noise cancelling earpieces that also provided the ability to communicate with the experimenter.” See paragraph [0097]) configured to emit white noise while the motion platform executes each of the discrete motions (“Aural white noise began playing in the subject's earpiece 300 ms before motion commenced and ended when the motion ended.” See paragraph [0097]), and a visual display configured to present visual information during testing or training (See rejection of claim 1).
Regarding claim 49:
Merfeld as modified by Briel teaches the vestibular training device of claim 1, further comprising a visual display configured to present visual information during testing or training (See rejection of claim 1).
Regarding claim 51:
Merfeld teaches a method for improving vestibular function and balance and reducing fall risk of a subject using a vestibular training device (“This disclosure relates to vestibular testing systems and methods.” See paragraph [0003]) comprising a motion platform (motion platform 110) configured to support the subject thereon and to execute a set of discrete motions (“During operation, the motion platform 110 supports the subject 150 and the controller 120 can provide a stimulus signal to the motion platform 110 for movement.” See paragraph [0006]); one or more input devices (input device 130) configured to enable the subject to provide responses to the motions executed by the motion platform (“During operation, the subject 150 provides an input to the input device 130 to communicate his or her perception of motion to the processor 140.” See paragraph [0076]), and a controller (The examiner notes that the system of Merfeld includes both a controller 120 and a processor 140 which together control the system overall) in communication with the motion platform (“The controller 120 can instruct (e.g., by providing stimuli signals) a predefined set of motions to the motion platform.” See paragraph [0081]), the one or more input devices, and the one or more feedback devices (“Alternatively, the controller 120 can instruct the motion platform based on the input received by the input device 130. For example, the processor 140 is configured to instruct the controller 120 to cause execution of those motions for which expected information about a subject's perception of those motions would most contribute to improving an estimate of a subject's vestibular threshold.” See paragraph [0081 and figure 14), the method comprising: causing the motion platform to execute a first motion (See above citation of paragraph [0081]); receiving, via the one or more input devices, a first response indicative of the subject's perception of the first motion (“During operation, the subject 150 provides an input to the input device 130 to communicate his or her perception of motion to the processor 140.” See paragraph [0076]); determining a second motion based at least in part on the first response(See above citation of paragraph [0081] where the users response to the motion cause the processor to instruct the controller what the next motion needs to be for the training session); and cause the motion platform to execute the second motion (See above citation of paragraph [0081]).
Merfeld fails to teach one or more feedback devices configured to provide the subject with feedback indicative of whether the responses are correct or incorrect; and that the controller causes the one or more feedback devices to provide first feedback indicative of whether the first response is correct or incorrect.
The examiner notes that due to the indefinite nature of the claim language, see 35 USC 112(b) rejection above, it must be mentioned that during trail phases of the training in Merfeld, as stated in paragraph [0100] that users were informed whether their responses to the perception of motion were correct or incorrect, implying that there was some feedback device capable of notifying the user, however it is not stated what structure or form this feedback device is in, or if it is connected to the controller of the system in any way.
Briel, however, teaches machines, systems, and methods for coordinated total body and brain exercise. Specifically, the invention relates to a stationary device adapted for cycling that is also equipped with a punch receiving surface with indicators for sequencing and coordinating punch repetition(s) (See abstract) and further teaches one or more feedback devices configured to provide the subject with feedback indicative of whether the responses are correct or incorrect (The examiner notes that due to the unclear nature of the claim language, see 35 USC 112(b) rejection above, the claimed limitation is being interpreted under the broadest reasonable interpretation with no further structural or functional limitations as anything capable of providing feedback to the user, and therefore the display 32 is a feedback device); cause the one or more feedback devices to provide first feedback indicative of whether the first response is correct or incorrect (“At a high level, the punch-and-cycle device is directed to detecting a punch to a target zone by a sensor unit, signaling a controller by the sensor unit in response to the step of detecting, and controlling the result (e.g. correct or incorrect) displayed by the target zone with regards to the accuracy and/or reaction time of the punch so delivered. For example, the target zone may illuminate in a different color or shape to indicate either a correct or incorrect punch.” See paragraph [0078]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Merfeld to include a feedback device which indicates correct or incorrect responses as taught by Briel, as this allows the user to be corrected as they perform training with the system allowing them to progress faster by being able to receive an indication of whether their choices were correct or incorrect without needing a coach or trainer, and without needing to stop exercise to receive a report of the training.
Regarding claim 52:
Merfeld as modified by Briel teaches the method of claim 51, further comprising: receiving, via the one or more input devices, a second response indicative of the subject's perception of the second motion(“As described above, the input device 130 can receive both the binary response and the confidence rating for a given motion, in other words, for each trial.” See paragraph [0080] of Merfeld. The examiner notes that the system is capable of a plurality of motions as noted in the rejection above for claim 51, and it can receive inputs for the binary response for each motion also noted above in the rejection of claim 51, and therefore simply adding motions and input requests is the same steps and structures merely repeated for each trial.); causing the one or more feedback devices to provide second feedback indicative of whether the second response is correct or incorrect (As noted above in the rejection of claim 51, the display will provide a response indicating a correct or incorrect input for each attempt at answering); determining a third motion based at least in part on the second response (As noted above in the rejection of claim 51, specifically paragraph [0081] of Merfeld the controller can use the inputs to determine what the next motion should be for each trial); and causing the motion platform to execute the third motion (See above citation of paragraph [0081] of Merfeld which is repeated for each trial).
Claim(s) 3-4,9 and 53-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merfeld et al. US 20190015035 A1 in view of Briel US 20210236903 A1, and further in view of Mobbs AU 2021106605 A4.
Merfeld as modified by Briel teaches the invention as substantially claimed above.
Regarding claim 3:
Merfeld as modified teaches the vestibular training device of claim 1, wherein the controller is further configured to: receive, via the one or more input devices, a second response indicative of the subject's perception of the second motion(“As described above, the input device 130 can receive both the binary response and the confidence rating for a given motion, in other words, for each trial.” See paragraph [0080] of Merfeld. The examiner notes that the system is capable of a plurality of motions as noted in the rejection above for claim 1, and it can receive inputs for the binary response for each motion also noted above in the rejection of claim 1, and therefore simply adding motions and input requests is the same steps and structures merely repeated for each trial.); causing the one or more feedback devices to provide second feedback indicative of whether the second response is correct or incorrect (As noted above in the rejection of claim 1, the display will provide a response indicating a correct or incorrect input for each attempt at answering); determine a plurality of additional motions based at least in part on the second response (As noted above in the rejection of claim 1, specifically paragraph [0081] of Merfeld the controller can use the inputs to determine what the next motion should be for each trial, which is repeated after each motion-answer step); cause the motion platform to execute the additional motions (The examiner notes that as stated above in the rejection of claim 1, specifically paragraph [0081] of Merfeld, that the motion platform performs a plurality of motions, each of which is determined by the previous response); receive, via the one or more input devices, a plurality of additional responses indicative of the subject's perception of the additional motions (The examiner notes again that Merfeld states, “As described above, the input device 130 can receive both the binary response and the confidence rating for a given motion, in other words, for each trial.” See paragraph [0080] of Merfeld. Therefore, the system is capable of a plurality of motions as noted in the rejection above for claim 1, and it can receive inputs for the binary response for each motion also noted above in the rejection of claim 1, and therefore simply adding motions and input requests is the same steps and structures merely repeated for each trial.); cause the one or more feedback devices to provide a plurality of additional feedback indicative of whether the additional responses are correct or incorrect (As noted above in the rejection of claim 1, the display will provide a response indicating a correct or incorrect input for each attempt at answering).
Merfeld fails to teach and determine a threshold of the subject based at least in part on the first response, the second response, and at least part of the additional responses, wherein the threshold is a biomarker for a fall risk of the subject.
Mobbs, however, teaches system and method for determining a fall risk of a subject a gait stability score for the subject from at least two gait metrics or a walking orientation randomness metric (WORM) score (See abstract) and further teaches determining a threshold of the subject based at least in part on the first response, the second response, and at least part of the additional responses (The examiner notes that paragraphs [096]-[101] discuss how the calculated WORM scores directly relate to thresholds regarding the fall risk of the users, which the system and methods of Mobbs determine the users WORM score through gait assessments and testing.), wherein the threshold is a biomarker for a fall risk of the subject (“The ‘WORM Score’ provides clinicians, patients, and carers with a quantification of walking instability serving as an accurate, and sensitive biomarker for monitoring functional balance and falls-risk.” See paragraph [091]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Merfeld to determine a fall risk from the user’s responses as taught by Mobbs, as this would allow the system to provide more detailed feedback regarding the user’s current vestibular function status and see how their fall risk lowers/improves during training.
Regarding claim 4:
Merfeld as modified teaches the vestibular training device of claim 3, but fails to teach wherein the controller is further configured to: determine that one of the additional responses is indicative of a lapse by the subject; and determine the threshold of the subject based at least in part on the first response, the second response, and at least part of the additional responses, while excluding the one of the additional responses indicative of a lapse by the subject.
Briel, however, teaches machines, systems, and methods for coordinated total body and brain exercise, specifically a stationary device adapted for cycling that is also equipped with a punch receiving surface with indicators for sequencing and coordinating punch repetition(s) (See abstract) and further teaches wherein the controller is further configured to: determine that one of the additional responses is indicative of a lapse by the subject (The examiner notes that due to the unclear nature of the claim language, see 35 USC 112(b) rejection above, since there is no definition as to what the applicant is considering a lapse by the subject, Briel discusses in paragraph [0086], “The computing unit (i.e. the processor in the punch pad, sensors, software and user interface), detects punches delivered to the individual target zones and also detects missed punches, i.e. where a target zone was illuminated but where the user failed to deliver a punch at all. Since the computing unit can detect missed punches, i.e. where the user was instructed to press the button, or punch the target in the case of Briel, and failed to do so these misses/failures are different from an incorrect response and are therefore under the broadest reasonable interpretation with no further structural or functional limitations are being considered as a lapse by the subject.) ; and determine the threshold of the subject based at least in part on the first response, the second response, and at least part of the additional responses, while excluding the one of the additional responses indicative of a lapse by the subject (“If no punch was detected, processor interprets a missed punch; If the punch was delivered to the incorrect target zone, the punch is scored as “incorrect”; In the case of a missed punch or incorrect punch, the target zone then illuminates in a different color e.g. red to give negative user feedback; The main processor receives the data from the processor in the punch pad regarding the accuracy, force, hit percentage.” See paragraph [0092]. The examiner notes that since correct punches are scored, incorrect punches are negatively scored, and missed punches are their own category which don’t go to the score, the misses are excluded from the overall score as lapses by the subject, where the overall score would be the threshold for the instant training session).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Merfeld to include the ability to determine a lapse in user response as taught by Briel, as this allows the system to filter out responses that might skew the results of the training sessions by causing an overabundance of negative scores to user responses where no incorrect response was present.
Regarding claim 9:
Merfeld as modified teaches the vestibular training device of claim 3, but fails to teach wherein the controller is further configured to compare the fall risk of the subject to values from a previously quantified population.
Mobbs, however, teaches system and method for determining a fall risk of a subject a gait stability score for the subject from at least two gait metrics or a walking orientation randomness metric (WORM) score (See abstract) and further teaches wherein the controller is further configured to compare the fall risk of the subject to values from a previously quantified population (“As described an exemplary embodiment has validated its utility to distinguish fallers from non-fallers within a sample population of 32 participants and demonstrates that the WORM Score identifies an 8-fold increase in fallers compared to non fallers.” See paragraph [085]. The examiner notes that Mobbs further specifies in paragraph [117] that non-fallers were found to have no previous history of falls, and therefore the non-faller group are a previously quantified population acting as a control or compare point to those being tested).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Merfeld to compare the fall risk of a subject to a previously quantified population as taught by Mobbs, as this allows the system to place each subject in a category based on their responses and tailor the motions, and testing sessions, to the type that would create the most beneficial outcome of training for each users specific needs.
Regarding claim 53:
Merfeld as modified teaches the method of claim 51, further comprising: receiving, via the one or more input devices, a second response indicative of the subject's perception of the second motion(“As described above, the input device 130 can receive both the binary response and the confidence rating for a given motion, in other words, for each trial.” See paragraph [0080] of Merfeld. The examiner notes that the system is capable of a plurality of motions as noted in the rejection above for claim 51, and it can receive inputs for the binary response for each motion also noted above in the rejection of claim 51, and therefore simply adding motions and input requests is the same steps and structures merely repeated for each trial.); causing the one or more feedback devices to provide second feedback indicative of whether the second response is correct or incorrect (As noted above in the rejection of claim 51, the display will provide a response indicating a correct or incorrect input for each attempt at answering); determining a plurality of additional motions based at least in part on the second response (As noted above in the rejection of claim 51, specifically paragraph [0081] of Merfeld the controller can use the inputs to determine what the next motion should be for each trial, which is repeated after each motion-answer step); causing the motion platform to execute the additional motions (The examiner notes that as stated above in the rejection of claim 51, specifically paragraph [0081] of Merfeld, that the motion platform performs a plurality of motions, each of which is determined by the previous response); receiving, via the one or more input devices, a plurality of additional responses indicative of the subject's perception of the additional motions (The examiner notes again that Merfeld states, “As described above, the input device 130 can receive both the binary response and the confidence rating for a given motion, in other words, for each trial.” See paragraph [0080] of Merfeld. Therefore, the system is capable of a plurality of motions as noted in the rejection above for claim 51, and it can receive inputs for the binary response for each motion also noted above in the rejection of claim 51, and therefore simply adding motions and input requests is the same steps and structures merely repeated for each trial.); causing the one or more feedback devices to provide a plurality of additional feedback indicative of whether the additional responses are correct or incorrect (As noted above in the rejection of claim 51, the display will provide a response indicating a correct or incorrect input for each attempt at answering).
Merfeld fails to teach determining a threshold of the subject based at least in part on the first response, the second response, and at least part of the additional responses, wherein the threshold is a biomarker for a fall risk of the subject.
Mobbs, however, teaches system and method for determining a fall risk of a subject a gait stability score for the subject from at least two gait metrics or a walking orientation randomness metric (WORM) score (See abstract) and further teaches determining a threshold of the subject based at least in part on the first response, the second response, and at least part of the additional responses (The examiner notes that paragraphs [096]-[101] discuss how the calculated WORM scores directly relate to thresholds regarding the fall risk of the users, which the system and methods of Mobbs determine the users WORM score through gait assessments and testing.), wherein the threshold is a biomarker for a fall risk of the subject (“The ‘WORM Score’ provides clinicians, patients, and carers with a quantification of walking instability serving as an accurate, and sensitive biomarker for monitoring functional balance and falls-risk.” See paragraph [091]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Merfeld to determine a fall risk from the user’s responses as taught by Mobbs, as this would allow the system to provide more detailed feedback regarding the user’s current vestibular function status and see how their fall risk lowers/improves during training.
Regarding claim 54:
Merfeld as modified teaches the method of claim 53, but fails to teach further comprising: determining that one of the additional responses is indicative of a lapse by the subject; and determining the threshold of the subject based at least in part on the first response, the second response, and at least part of the additional responses, while excluding the one of the additional responses indicative of a lapse by the subject.
Briel, however, teaches machines, systems, and methods for coordinated total body and brain exercise, specifically a stationary device adapted for cycling that is also equipped with a punch receiving surface with indicators for sequencing and coordinating punch repetition(s) (See abstract) and further teaches wherein the controller is further configured to: determine that one of the additional responses is indicative of a lapse by the subject (The examiner notes that due to the unclear nature of the claim language, see 35 USC 112(b) rejection above, since there is no definition as to what the applicant is considering a lapse by the subject, Briel discusses in paragraph [0086], “The computing unit (i.e. the processor in the punch pad, sensors, software and user interface), detects punches delivered to the individual target zones and also detects missed punches, i.e. where a target zone was illuminated but where the user failed to deliver a punch at all. Since the computing unit can detect missed punches, i.e. where the user was instructed to press the button, or punch the target in the case of Briel, and failed to do so these misses/failures are different from an incorrect response and are therefore under the broadest reasonable interpretation with no further structural or functional limitations are being considered as a lapse by the subject.) ; and determine the threshold of the subject based at least in part on the first response, the second response, and at least part of the additional responses, while excluding the one of the additional responses indicative of a lapse by the subject (“If no punch was detected, processor interprets a missed punch; If the punch was delivered to the incorrect target zone, the punch is scored as “incorrect”; In the case of a missed punch or incorrect punch, the target zone then illuminates in a different color e.g. red to give negative user feedback; The main processor receives the data from the processor in the punch pad regarding the accuracy, force, hit percentage.” See paragraph [0092]. The examiner notes that since correct punches are scored, incorrect punches are negatively scored, and missed punches are their own category which don’t go to the score, the misses are excluded from the overall score as lapses by the subject, where the overall score would be the threshold for the instant training session).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Merfeld to include the ability to determine a lapse in user response as taught by Briel, as this allows the system to filter out responses that might skew the results of the training sessions by causing an overabundance of negative scores to user responses where no incorrect response was present.
Allowable Subject Matter
Claims 10, 14-15, and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, either alone or in combination, fails to teach or disclose the vestibular training device of dependent claim 10, including specifically wherein the controller is further configured to: determine that the fall risk of the subject is acceptable when the threshold is below a predetermined percentile for young healthy adults; and determine that training of the subject is recommended when the threshold is above the predetermined percentile.
The closest prior art of record includes Reed et al. US 20220125336 A1, Mobbs AU 2021106605 A4, Waddington et al. US 20220386936 A1, and Chu US 20110312473 A1.
Reed et al. US 20220125336 A1: Asymmetrical Rhythmic Auditory Cueing Based Gait Modification, which teaches a method, apparatus, or system for modifying and assessing gait asymmetry, including measuring a first baseline step time for a first leg of an individual and a second baseline step time for a second leg of the individual and determining a first target step time for the first leg and a second target step time for the second leg. The first baseline step time can be shorter than the second baseline step time. The first target step time can be different from the second target step time. The method may further include generating a series of auditory cues comprising a first cue duration corresponding to the first target step time and a second cue duration corresponding to the second target step time for synchronizing the first baseline step time and the second baseline step time with the first target step time and the second target step time, respectively. In addition, Reed discusses that compared to the groups of healthy young adults tested, subjects not in the healthy young adult groups such as stroke victims and amputees, are at more of a fall-risk due to greater gait asymmetry can lessen their fall risk when training with the system.
Reed, however, fails to teach that the method, apparatus, or system can determine that the fall risk of the subject is acceptable when the threshold is below a predetermined percentile for young healthy adults; and determine that training of the subject is recommended when the threshold is above the predetermined percentile.
Mobbs AU 2021106605 A4: System and Method for Determining Fall Risk, which teaches a system and method for determining a fall risk of a subject a gait stability score for the subject from at least two gait metrics or a walking orientation randomness metric (WORM) score, where if one or more of the scores falls outside a predetermined range the subject is at risk of falling. Furthermore, as discussed in the rejections above Mobbs creates biomarkers which indicate the fall risk of a subject as a result of their responses during testing which correlates to the WORM score of that subject.
However, Mobbs fails to teach a comparison to young healthy adults as paragraph [117] discusses the criteria of the faller and non-faller control groups where it states, “16 participants recruited as 'fallers' had a range of comorbidities including delirium, osteoarthritis, lumbar radiculopathy, scoliosis, vestibular imbalance, cervical myelopathy, foot drop and stroke-related hemi-paresis. The 16 control participants recruited as 'non-fallers' had various comorbidities consistent with their age such as osteoarthritis of the spine and lower extremities, however had no history of falls”. Therefore, Mobbs fails to teach that the system can determine that the fall risk of the subject is acceptable when the threshold is below a predetermined percentile for young healthy adults; and determine that training of the subject is recommended when the threshold is above the predetermined percentile.
Waddington et al. US 20220386936 A1: A System, Apparatus and Method for Measuring Dynamic Visual, Vestibular and Somatosensory ability which teaches an apparatus for making combined vestibular and somatosensory function assessments, comprising: a portable base unit comprising: a movable platform being at least partially rotatable about an axis of rotation; in use, a user stands with both feet on the movable platform; an adjustable stopping mechanism for adjusting an extent to which the movable platform can rotate in at least one direction with respect to a horizontal plane; and a controller for controlling the adjustable stopping mechanism to selectively adjust the extent to which the movable platform is rotated by one of a plurality of discrete measurable amounts based on a control signal; a visual occlusion headset worn by the user, the headset comprising a device for recording a vestibular function response in response to a vestibular function test.
Waddington fails to teach however, that the apparatus can determine that the fall risk of the subject is acceptable when the threshold is below a predetermined percentile for young healthy adults; and determine that training of the subject is recommended when the threshold is above the predetermined percentile.
Chu US 20110312473 A1: Training System and Method Using a Dynamic Perturbation Platform which teaches an apparatus, system and method for fall prevention training is provided that delivers, studies and analyzes the biomechanics of a disturbance event, such as a slip or trip incident, so that an appropriate response can be executed by the person to reduce or eliminate the number of falls experienced, including testing various stages of gait while perturbation occurs and creating thresholds for each stage.
Chu fails to teach however, that the system/methods can determine that the fall risk of the subject is acceptable when the threshold is below a predetermined percentile for young healthy adults; and determine that training of the subject is recommended when the threshold is above the predetermined percentile.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN ANGELO DICUIA whose telephone number is (703)756-4713. The examiner can normally be reached M-F 7:30-4:30.
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/J.A.D./Examiner, Art Unit 3784
/Megan Anderson/Primary Examiner, Art Unit 3784