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 .
Claim Objections
Claims 1-3, 10, 14, and 24 are objected to because of the following informalities:
Claims 1 and 2: “said remote computing system configured to communicate” should be replaced with “said remote computing system is configured to communicate”
Claims 1, 2, and 24: “…in the event that the further sensor data from the one or more sensor data falls within…” should be replaced with “…in the event that the further sensor data from the one or more sensors falls within…”
Claim 2: “…configured to receive, via the data communication means, the further calibration sensor data, process…” should be replaced with “…configured to receive, via the data communication means, the further calibration sensor data, and process…”
Claim 3 should end with a period.
Claim 10: “whereby” should be replaced with “wherein”
Claim 14: “senor” should be replaced with “sensor”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10, 13-19, 24, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 refers to “the remote computing system” then later refers to “said remote computing system,” which has insufficient antecedent basis. Both wordings are used in other claims. For examination purposes, it will be assumed that both refer to the same remote computing system. To correct this, use either “the” or “said” throughout the claims.
Additionally, claim 1 refers to “said data transceiver” then later refers to “the data transceiver,” which has insufficient antecedent basis. Both wordings are used in other claims. For examination purposes, it will be assumed that both refer to the same data transceiver. To correct this, use either “the” or “said” throughout the claims.
Claim 2 recites “a program of therapy, training, or movement assistance,” and it is unclear whether this refers to the same program as recited in claim 1 or to another program. For examination purposes, it will be assumed that “a” should be replaced with “the” in the above quote.
Claim 7 refers to “the data processor.” This has insufficient antecedent basis, as claim 1 referred to “said data processor.” Both wordings are used in other claims. For examination purposes, it will be assumed that both refer to the same thing. To correct this, use either “the” or “said” throughout the claims.
Claim 16 refers to “said predicted distribution of sensor data values.” This has insufficient antecedent basis, as claim 1 referred to “the predicted distribution of sensor data values.” Both wordings are used in other claims. For examination purposes, it will be assumed that both refer to the same thing. To correct this, use either “the” or “said” throughout the claims.
Claim 19 refers to “said one or more vibration actuators.” This has insufficient antecedent basis, as claim 1 referred to “the one or more vibration actuators.” For examination purposes, it will be assumed that both refer to the same thing. To correct this, replace “said” with “the”.
Claims 24 and 27 are written as dependent on claim 1, but recite a number of elements such as “a data processor” without referring to those elements already recited in claim 1. This causes confusion as to whether claims 24 and 27 intend to refer to the same elements recited in claim 1, or to different elements. See also the rejection of claims 24 and 27 under 35 USC 112(d). For examination purposes, it will be assumed that claims 24 and 27 are independent claims, where “a system according to claim 1” is replaced with the text of claim 1.
Claims 3-6, 8-10, 13-15, and 17-18 depend from claim 1, therefore they inherit the issues of claim 1 and are rejected for the same reasons.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24 and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 24 recites “an arrangement for fitting to an item of footwear for use in a system according to claim 1.” The language “for use in” represents a statement of intended use (MPEP 2111.02(II)). Therefore, it is possible for prior art to disclose an arrangement for fitting to an item of footwear according to claim 24 and which is usable in the system according to claim 1, but which does not actually disclose all of the elements of claim 1. In such a scenario, the limitations of claim 24 would be infringed, but claim 1 itself would not be. Therefore, claim 24 is not construed to “incorporate by reference all the limitations of the claim to which it refers.”
Claim 27 recites “a computer program for running on a data processor incorporated in an item of footwear and for use in a system according to claim 1.” As in claim 24, the phrase “for use in” represents a statement of intended use, and it is possible for prior art to disclose software which implements the method outlined in claim 27 and which is usable in the system according to claim 1, but which does not actually disclose all of the elements of claim 1. For the reasons given in the rejection of claim 24, claim 27 is not construed to “incorporate by reference all the limitations of the claim to which it refers.”
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 27 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because it is directed to software per se (see MPEP 2106.03). The examiner suggests reciting a “non-transitory computer-readable medium having thereon a computer program comprising” which would fall within either the apparatus or article of manufacture category of patent subject matter.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6, 9, 16-19, 23-24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1).
Regarding claim 1, Pretzer-Aboff discloses a system for applying sensory stimulation to a subject's foot or ankle based on detected gait kinematics for therapy, training, or movement assistance (Abstract: “A device adapted to be secured to the foot of a user includes one or more vibration actuators configured to provide vibrations to the user's foot”; ¶6: “The controller may…operate in a feedback mode in which the plurality of vibration actuators are activated to provide vibration to the foot of the user based directly upon information sensed by the one or more force or acceleration sensors.” ¶18: “The systems and methods disclosed herein are usable to improve a user's gait, e.g., by developing or maintaining the user's natural walking ability. Generally, these systems and related methods for generating vibration that assists a user walking under the user's own power to avoid Freezing of Gait”), said system comprising:
at least one item of footwear (Fig. 1A, shoe 110) incorporating one or more sensors (Fig. 1A, force or acceleration sensors 130-130c), one or more vibration actuators (Fig. 1A, vibration actuators 150a and 150b), a data processor (Fig. 1A, microprocessor 170), memory (¶25: “Vibratory system 100 may include a data storage component), and a data transceiver (¶27: “The communications modules 180, 181, 183 are preferably transceivers”; see Fig. 1A, wireless communication module 180), and
a remote computing system comprising data communication means and data processing means (¶26: “A centralized monitoring center may remotely monitor user data from multiple systems at the same time. Sensor data may be further processed and analyzed to identify characteristics of the user's gait”; Fig. 1A, remote monitoring unit 182 and cloud 184).
Pretzer-Aboff does not explicitly disclose all of the remaining limitations of claim 1.
Plotnik-Peleg teaches a method and system for detecting, predicting, and treating freezing of gait (FOG) (Abstract). As part of the invention, Plotnik-Peleg teaches generating sensor data associated with movement of a subject, and communicating the sensor data to a computing system, which is then configured to process the sensor data to generate one or more parameters associated with a subject’s gait kinematics (¶318: “a short monitoring period may be carried out during which [an] algorithm learns [a] patient's normal (e.g., variable or not) gait as well as freezing episodes”) and generate, using the parameters and one or more program parameters associated with a program of therapy, training, or movement assistance (¶318: the monitoring may include input from “a user [to] tag suspected FOG events and these can be used to subsequently teach the algorithm”), predictions about the kind of movement which indicates a risk for FOG (¶48: “measurements of gait are used to identify an increased risk for imminent FOG and preventive action is optionally taken”). If further measured data satisfies the predictions, sensory stimulation may be applied (¶169: “such a system, in addition to or alternatively to providing warnings, provides signals or cues to help prevent and/or break out of a FOG situation. This could be in the form of vibratory or auditory cues or electrical stimulation to a limb or other part of the body.”).
While Plotnik-Peleg does not explicitly teach that the predictions involve generating predicted distributions of sensor data values, however it would have been obvious to do so in order to provide some quantitative method for concluding whether a set of sensor measurements satisfy or do not satisfy the predictions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Plotnik-Peleg with the invention of Pretzer-Aboff by:
configuring said sensors to, during a calibration phase, generate calibration sensor data associated with movement of a subject wearing the item of footwear and said data transceiver is configured to communicate the calibration sensor data to the remote computing system, and
configuring the remote computing system to
receive, via the data communication means, the calibration sensor data from the item of footwear, and process, using the data processing means, the calibration sensor data to:
generate one or more gait parameters associated with the subject's gait kinematics;
generate, using the gait parameters and one or more program parameters associated with a program of therapy, training, or movement assistance, a predicted distribution of sensor data values within which further sensor data generated by the one or more sensors is predicted to fall in the event of movement of the subject requiring sensory stimulation to be applied in accordance with the program of therapy, training or movement assistance,
communicate, via the data communication means, the predicted distribution of sensor data values to said data transceiver, and
configuring said data transceiver to receive the predicted distribution of sensor data values and said memory to store the predicted distribution of sensor data values,
whereupon, during an operational phase said data processor is configured to monitor further sensor data from the one or more sensors, and, in the event that the further sensor data from the one or more sensors falls within the predicted distribution of sensor data values, said data processor is configured to control the one or more vibration actuators to provide sensory stimulation in accordance with the program of therapy, training or movement assistance.
Doing so would enable one to use past data to make predictions about future risk events, then monitor for risk factors and provide physical stimuli to prevent or mitigate FOG. Furthermore, by sending the predictions directly to the shoe, risk factors can be monitored and addressed even in the event that communications with a remote computing module fails.
Regarding claim 23, claim 23 recites the method applied by the system of claim 1 and is therefore rejected for the same reasons.
Regarding claim 24, claim 24 recites an arrangement for fitting to an item to be sued in a system according to claim 1, but does not recite any further limitations not found within claim 1. Claim 24 is therefore rejected for the same reasons as claim 1.
Regarding claim 27, claim 27 recites a computer program, implemented in a processor in an item of footwear, which is capable of performing the method performed by the data processor of claim 1. Pretzer-Aboff discloses that the controller 17 is programmed (¶24). The other limitations of claims 27 are found in claim 1. It would have been obvious to one of ordinary skill in the art to provide software to enable the item of footwear to perform its functions autonomously. Other arguments for the rejection of claim 27 are found in the rejection of claim 1.
Regarding claim 2, claim 2 merely recites collecting more sensor data, using the extra data to update the predictive distribution, and sending the updated distribution to the item of footwear so it may compare values to the updated predictive distribution. It would have been obvious to one of ordinary skill in the art practicing the invention of Pretzer-Aboff in view of Plotnik-Peleg to do this in order to make more accurate FOG predictions. Plotnik-Peleg also implies a similar process of collecting more data to refine predictions (¶318: “a short monitoring period may be carried out during which [an] algorithm learns [a] patient's normal (e.g., variable or not) gait as well as freezing episodes” and “a user [may] tag suspected FOG events and these can be used to subsequently teach the algorithm”; it is common in teaching to progress iteratively from worse to better predictions as more data is gathered). The rest of the limitations are found in the language of claim 1.
Regarding claim 3, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 2. Furthermore, it would have been obvious to one of ordinary skill in the art practicing the invention of Pretzer-Aboff in view of Plotnik-Peleg to configure the data processing means to periodically generate the updated predicted distribution of sensor data values at a predetermined interval and/or responsive to an update signal from the remote computing system. Doing so would enable the remote computing system to make more accurate FOG predictions over time (see rejection of claim 2; note that the limitations of claim 2 imply the limitations of claim 3, since the remote computing system would surely generate a command signal to perform an update to the predicted distribution prior to carrying out the command).
Regarding claim 4, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1. Plotnik-Peleg further teaches that the gait parameters include one or more of step length, rhythm, asymmetry, and step characteristics (¶188: “one or more of the following features which may be found in FOG patients (especially secondary to PD) are measured and/or monitored, especially in response to various provocations: Impairments in step length scaling, reduced dynamic control of postural stability, increased gait asymmetry, poor bilateral coordination of gait and rhythmicity”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Plotnik-Peleg with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the gait parameters to include one or more of step length, rhythm, asymmetry, and step characteristics. Doing so would enable one to consider how those factors may individually or in combination affect FOG.
Regarding claim 6, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, and Pretzer-Aboff further discloses that the item of footwear incorporates a plurality of vibration actuators (Abstract: “A device adapted to be secured to the foot of a user includes one or more vibration actuators”).
Regarding claim 9, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, and Pretzer-Aboff further discloses that the sensory stimulation is tactile cueing (¶18: “these systems and related methods [are] for generating vibration that assists a user walking under the user's own power to avoid Freezing of Gait (FoG).” Tactile cueing describes physical sensations to describe actions, convey information, or help someone develop a skill, such as avoiding FOG.).
Regarding claim 16, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1. Furthermore, Plotnik-Peleg teaches that FOG is related to falling risk (¶5: “FOG has a grave impact on quality of life as it is largely associated with falls”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Plotnik-Peleg with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the program of therapy, training or movement assistance to be a program of movement assistance for alerting a subject to a potential fall, the predicted distribution of sensor data values corresponding to a range of sensor values predicted to arise in the event the subject's gait kinematics change in such a way indicating an imminent fall, said data processor thereby operable to control the one or more vibration actuators to generate sensory stimulation in the event of an imminent fall being detected. Doing so would enable one to attempt to mitigate fall risks, which are a serious health hazard and are associated with FOG.
Regarding claim 17, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1 and further teaches the limitations of claim 17 (the “program of therapy, training or movement assistance” for both Pretzer-Aboff and Plotnik-Peleg is a program of training patients to avoid or mitigate the effects of FOG; see rejection of claim 1).
Regarding claim 18, inasmuch as movement indicating an imminent FOG episode can be described as undesirable movement, the arguments for rejecting claim 17 may be used to reject claim 18.
Regarding claim 19, inasmuch as movement indicating an imminent FOG episode can be described as desirable movement, the arguments for rejecting claim 17 may be used to reject claim 18 (one could argue that the movement is desirable in the sense that it presages FOG without actually signaling an episode of FOG, thus it grants the technology an opportunity to prevent FOG. In any case, whether the movement is considered “desirable” or “undesirable” is a matter of perspective.).
Claims 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1), and further in view of Galica (“Subsensory Vibrations to the Feet Reduce Gait Variability in Elderly Fallers”).
Regarding claim 5, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1 but does not teach the limitations of claim 5.
Galica teaches that subsensory vibrations can reduce gait variability, which may reduce fall risk (Abstract).
Plotnik-Peleg also teaches that high gait variability may account for higher FOG risk (¶304: “high variability of gait…could account [for] a higher risk for FOG’s”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Galica and Plotnik-Peleg with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the one or more vibration actuators to be configured to generate sub-sensory vibration. Doing so could reduce gait variability, thereby reducing probable risk factors for FOG.
Regarding claim 7, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1 but does not teach the limitations of claim 7.
Following the reasoning in the rejection of claim 5, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Galica and Plotnik-Peleg with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the one or more vibration actuators to be configured to generate sub-sensory vibration (see rejection of claim 5).
Noting the above, it also would have been obvious to configure the data processor to actuate each vibration actuator to generate foot stimulating vibration at a vibration level determined during a calibration process in which a subject's sensory perception is assessed at each foot position corresponding to a position of each vibration actuator thereby accommodating differences in sensory perception across the subject's foot. Doing so would enable one to assess the sensory threshold at each actuator location, thereby enabling one to provide sub-sensory vibration from any of the actuators.
Regarding claim 8, Pretzer-Aboff in view of Plotnik-Peleg and Galica teaches the limitations of claim 7. Noting that vibrations are typically associated with a frequency and amplitude, it would have been obvious to cause the vibration level to comprise a predetermined vibration frequency and/or predetermined vibration amplitude in order to provide a predetermined sub-sensory vibration.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1), and further in view of Sperling (GB 2538445 A).
Regarding claim 10, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, but does not explicitly teach the limitations of claim 10.
Sperling teaches including a vibration motor in the insole of an item of footwear (Pg. 8, ¶1: “the insole comprises a pressure sensor 120 and a vibration motor 130”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Sperling with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the one or more vibration actuators to be embedded insole of the at least one item of footwear in order to provide vibration to the person’s foot.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1), and further in view of Cha (US 10132646 B1).
Regarding claim 13, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, and Pretzer-Aboff further discloses that the sensors comprise one or more of an accelerometer (Abstract). Pretzer-Aboff in view of Plotnik-Peleg does not explicitly teach that the one or more sensors comprise one or more inertial measurement units (IMUs) comprising one or more of an accelerometer, gyroscope, and magnetometer.
Cha discloses a shoe with an IMU to gather ambulation data (Fig. 1, shoe 5 with IMU 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Cha with the invention of Pretzer-Aboff in view of Plotnik-Peleg to cause the one or more sensors to comprise one or more inertial measurement units (IMUs) comprising one or more of an accelerometer, gyroscope, and magnetometer. IMUs are useful for tracking an object’s motion, including a person’s.
Regarding claim 14, Pretzer-Aboff in view of Plotnik-Peleg and Cha teaches the limitations of claim 13. Pretzer-Aboff further discloses that the one or more sensors comprise a foot-pressure sensor (¶21: “In the exemplary embodiment shown in FIG. 1A, force (e.g. pressure) sensors 130a-130c include a heel sensor 130a configured to sense a force exerted by the user's heel, a ball sensor 130b configured to sense a force exerted by the ball of the user's foot, and a toe sensor 130c configured to sense a force exerted by one or more of the user's toes.”).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pretzer-Aboff (US 20220015500 A1) in view of Plotnik-Peleg (US 20140303508 A1), and further in view of Ashby (US 20190151712 A1).
Regarding claim 15, Pretzer-Aboff in view of Plotnik-Peleg teaches the limitations of claim 1, but does not explicitly teach the limitations of claim 15.
Ashby teaches a shoe which includes sensors enabling one to track distance traveled (¶5: “a shoe includes…a sensor coupled to and surrounded by the [shoe’s] sole.” ¶11: “The sensor can include an accelerometer and a gyroscope, wherein the accelerometer and gyroscope can be configured to detect one of a stride length, distance traveled, or gait cadence.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Ashby with the invention of Pretzer-Aboff in view of Plotnik-Peleg by causing the at least one item of footwear to further incorporate movement distance tracking means configured to generate movement distance data associated with a distance moved by the item of footwear, and by causing the remote computing system to run thereon a movement distance analysis function, wherein said data transceiver is configured to communicate the movement distance data to the remote computing system for analysis by the movement distance analysis function to generate movement distance analysis data. Doing so would enable one to incorporate distance data among the number of factors which may individually or in combination provide a prediction regarding FOG risk.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ETHAN WESLEY EDWARDS whose telephone number is (571)272-0266. The examiner can normally be reached Monday - Friday, 7:30am-5pm.
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ETHAN WESLEY EDWARDS
Examiner
Art Unit 2857
/E.W.E./ Examiner, Art Unit 2857
/ANDREW SCHECHTER/ Supervisory Patent Examiner, Art Unit 2857