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
Claim 12 is objected to because of the following informalities: in line 2 of the claim “the detected activity state” lacks sufficient antecedent basis as the claim is dependent from claim 1. The claim will be interpreted as dependent from claim 11 for the purpose of examination.
Claim 75 is objected to because of the following informalities: in line 2 of the claim “the walking assistance device” lacks sufficient antecedent basis as the claim is dependent from claim 69. The claim will be interpreted as dependent from claim 74 for the purpose of examination.
Claims 100-101 is objected to because of the following informalities: in line 2 of the claim “gait cues” lacks sufficient antecedent basis because claim 1 uses the term “audio cues” rather than “gait cues”. For the purpose of examination, the “gait cues” will be interpreted as “audio cues”.
Claim 101 is objected to because of the following informalities: in line 1 of the claim “the sit-to-stand transition” lacks sufficient antecedent basis as the claim is dependent from claim 1. The claim will be interpreted as dependent from claim 100
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 69, 71, 74-75, 78, and 90 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claims 69 and 78 claim an ear-wearable device with a control circuit, motion sensor, microphone, electroacoustic transducer, for monitoring a user’s gait and comparing or matching the current gait to a stored gait pattern, and characterizing the user’s gait or health based on the comparison.
Claims 71, 74-75, and 90 include additional determinations from the measured data.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 69 recites the following limitations:
match the set of data against a plurality of predetermined patterns to characterize the current gait
Claim 78 recites the following limitations:
compare the set of data against stored data reflecting a previous gait of the device wearer
characterize a health status of the device wearer based on a change from the previous gait to the current gait of the device wearer.
The above identified claim limitations comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual performing the claimed evaluation of gait or health mentally or with the aid of a pencil and paper. They do not require any specific computer implementation or details of computer technology and therefore are directed to a mental process of evaluating a subject’s gait using human equivalent decision-making or judgment.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claim 69, 78: ear-wearable device, control circuit, motion sensor, microphone, electroacoustic transducer, generating a set of data
The sensors (motion sensor, microphone) are recited without reference to a sensor structure or particular data acquired. The list of data does not confer any particular structure or even active sensor sampling of the subject. Even in considering the ear-wearable device, the sensors are merely gathering data prior to performance of the identified abstract idea. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The control circuit and electroacoustic transducer (a speaker, e.g.) appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The additional elements were identified in the analysis under Step 2A Prong Two, above.
The sensors (motion sensor, microphone) are recited without reference to a sensor structure or particular data acquired. The list of data does not confer any particular structure or even active sensor sampling of the subject. Even in considering the ear-wearable device, the sensors are merely gathering data prior to performance of the identified abstract idea. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The control circuit and electroacoustic transducer (a speaker, e.g.) appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 11, 14-18, 69, 71, 78, and 96-98 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fancourt et al. (U.S. Patent Application Publication No. 2007/0112287) hereinafter referred to as Fancourt; in view of Brokaw (U.S. Patent No. 9,974,478) hereinafter referred to as Brokaw.
Regarding claim 1, Fancourt teaches an ear-wearable device (Fig. 2A-B) comprising:
a control circuit (¶[0023] processor);
a motion sensor, wherein the motion sensor is in electrical communication with the control circuit (Fig. 1, ¶[0023] accelerometer, gyroscope, level meter, ¶[0026]);
an electroacoustic transducer, wherein the electroacoustic transducer is in electrical communication with the control circuit (Fig. 1, ¶[0023] speaker);
wherein the ear-wearable device is configured to calculate one or more gait parameters (¶[0027] relevant gait features); and
Fancourt does not teach a microphone or providing a series of audio cues to a device wearer consistent with the one or more desired gait parameters.
Attention is brought to the Brokaw reference, which teaches a microphone (col. 21, lines 51-57), wherein the microphone is in electrical communication with a control circuit (col. 22, lines 53-57); and providing a series of audio cues to a device wearer (col. 43, lines 8-20) consistent with one or more desired gait parameters (col. 43, lines 20-23; col. 61, lines 36-48).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the ear-wearable device of Fancourt to include a microphone and audio cues, as taught by Fancourt, because Brokaw teaches additional kinematic features provide a more detailed picture of the motions of a body (col. 35, lines 38-42) and that audio cues can be delivered discreetly and avoid embarrassing reactions and social stigma (Brokaw, col. 44, lines 54-60).
Regarding claim 11, Fancourt as modified teaches the ear-wearable device of claim 1.
Brokaw further teaches wherein the ear-wearable device is configured to initiate or discontinue the series of audio cues based on a detected activity state as reflected in data from the motion sensor and/or the microphone (col. 43, lines 46-57).
Regarding claim 14, Fancourt as modified teaches the ear-wearable device of claim 1.
Brokaw further teaches wherein the ear-wearable device is configured to initiate the series of audio cues based on detection of an abnormal or atypical gait (col. 43, lines 46-57).
Regarding claim 15, Fancourt as modified teaches the ear-wearable device of claim 1.
Brokaw further teaches wherein the ear-wearable device is configured to initiate the series of audio cues based on detection of a gait with a step timing variability or statistics crossing a threshold value (Fig. 20, col. 34, lines 51-63, col. 57, lines 1-29, col. 60, lines 1-20 in the algorithms, statistical analysis includes machine learning models, and threshold changes or symptomatic gait initiates the cueing).
Regarding claim 16, Fancourt as modified teaches the ear-wearable device of claim 15.
Fancourt further teaches wherein the threshold value is set through evaluation of previous events related to the gait of the device wearer (¶[0012] each individual’s unique nominal gait patterns are considered the “normal” and deviations are detected, ¶¶[0030-0031]).
Regarding claim 17, Fancourt as modified teaches the ear-wearable device of claim 15.
Fancourt further teaches wherein the threshold value is set through evaluation of previous events including continued walking with appreciably the same gait metrics (¶[0012] each individual’s unique nominal gait patterns are considered the “normal” and deviations are detected, ¶¶[0030-0031]).
Regarding claim 18, Fancourt as modified teaches the ear-wearable device of claim 1.
Brokaw further teaches wherein the ear-wearable device is configured to initiate the series of audio cues based on detection of a gait with a left-right symmetry variability or statistics crossing a threshold value (Fig. 20, col. 34, lines 51-63, col. 57, lines 1-29, col. 60, lines 1-20 in the algorithms, statistical analysis includes machine learning models, and threshold changes or symptomatic gait initiates the cueing).
Regarding claim 69, Fancourt teaches an ear-wearable device (Fig. 2A-B) comprising:
a control circuit (¶[0023] processor);
a motion sensor, wherein the motion sensor is in electrical communication with the control circuit (Fig. 1, ¶[0023] accelerometer, gyroscope, level meter, ¶[0026]);
an electroacoustic transducer, wherein the electroacoustic transducer is in electrical communication with the control circuit (Fig. 1, ¶[0023] speaker);
wherein the ear-wearable device is configured to generate a set of data reflecting a current gait of a device wearer based on signals from at least the motion sensor (¶[0030] relevant gait features extracted from current state estimations); and
match the set of data against a predetermined pattern to characterize the current gait (¶[0030] matched to normal gait pattern, looking for deviation).
Fancourt does not teach a microphone or matching the set of data against a plurality of predetermined patterns to characterize the current gait.
Attention is drawn to the Brokaw reference, which teaches a microphone (col. 21, lines 51-57), wherein the microphone is in electrical communication with a control circuit (col. 22, lines 53-57); and matching a set of data against a plurality of predetermined patterns to characterize a current gait (col. 5, lines 40-49, col. 34, lines 51-63).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the ear-wearable device of Fancourt to include a microphone and matching predetermined patterns, as taught by Fancourt, because Brokaw teaches additional kinematic features provide a more detailed picture of the motions of a body (col. 35, lines 38-42) and improving the functional motor recovery and safety and stability of movement of a subject suffering from an injury or from a movement disorder (Brokaw, col. 4, lines 57-63).
Regarding claim 71, Fancourt as modified teaches the ear-wearable device of claim 69.
Brokaw further teaches wherein the ear-wearable device is configured to determine whether the characterized current gait reflects a musculoskeletal injury or imbalance (col. 35, lines 1-24).
Regarding claim 78, Fancourt teaches an ear-wearable device (Fig. 2A-B) comprising:
a control circuit (¶[0023] processor);
a motion sensor, wherein the motion sensor is in electrical communication with the control circuit (Fig. 1, ¶[0023] accelerometer, gyroscope, level meter, ¶[0026]);
an electroacoustic transducer, wherein the electroacoustic transducer is in electrical communication with the control circuit (Fig. 1, ¶[0023] speaker);
wherein the ear-wearable device is configured to generate a set of data reflecting a current gait of a device wearer based on signals from at least the motion sensor (¶[0030] relevant gait features extracted from current state estimations); and
compare the set of data against stored data reflecting a previous gait of the device wearer (¶¶[0030-0031] determine deviation by comparison to unique nominal gait of the user).
Fancourt does not teach a microphone or characterizing a health status of the device wearer based on a change from the previous gait to the current gait of the device wearer.
Attention is drawn to the Brokaw reference, which teaches a microphone (col. 21, lines 51-57), wherein the microphone is in electrical communication with a control circuit (col. 22, lines 53-57); and characterizing a health status of the device wearer based on a change from the previous gait to the current gait of the device wearer (col. 60, lines 50-end).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the ear-wearable device of Fancourt to include a microphone and characterizing the health status of a user, as taught by Fancourt, because Brokaw teaches additional kinematic features provide a more detailed picture of the motions of a body (col. 35, lines 38-42) and improving the functional motor recovery and safety and stability of movement of a subject suffering from an injury or from a movement disorder (Brokaw, col. 4, lines 57-63).
Regarding claim 96, Fancourt as modified teaches the ear-wearable device of claim 1.
Brokaw further teaches wherein the ear-wearable device is configured to change the audio cues over a period of time to transition from an existing gait to a preferred gait (col. 46, lines 23-32, col. 47, lines 2-6, col. 54, lines 1-17 and col. 61, lines 1-19; the change in audio cues can be to increase the intensity or urgency, clinician modified, and/or to increase or reduce cueing based on symptom severity of the user).
Regarding claim 97, Fancourt as modified teaches the ear-wearable device of claim 96.
Brokaw further teaches wherein the period of time to transition is hours, days, or weeks (col. 61, lines 28-48, the device is used over multiple days to improve the user’s symptoms, col. 24 lines 33-35).
Regarding claim 98, Fancourt as modified teaches the ear-wearable device of claim 1.
Brokaw further teaches wherein the ear-wearable device is configured to change the audio cues over a period of time to transition from an existing gait to a more symmetrical gait (col. 60, lines 1-20, and col. 46, lines 23-32, col. 47, lines 2-6, col. 54, lines 1-17 and col. 61, lines 1-19; the change in audio cues can be to increase the intensity or urgency, clinician modified, and/or to increase or reduce cueing based on symptom severity of the user).
Claim(s) 74-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fancourt and Brokaw as applied to claim 69 above, and further in view of McCarthy et al. (U.S. Patent Application Publication No. 2017/0296116) hereinafter referred to as McCarthy.
Regarding claims 74-75, Fancourt as modified teaches the ear-wearable device of claim 69.
Fancourt as modified teaches the ear-wearable device performing sensing, as in the rejection of claim 69, above.
Fancourt as modified does not teach identifying whether the device wearer is using a walking assistance device, wherein the walking assistance device comprising a cane, a walker, a knee walker, or crutches.
Attention is drawn to the McCarthy reference, which teaches identifying whether the device wearer is using a walking assistance device, wherein the walking assistance device comprising a cane, a walker, a knee walker, or crutches (¶[0144], ¶[0135]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Fancourt as modified to include identifying assistive device use, as taught by McCarthy, to improve gait cueing, accommodating the assistive device (McCarthy ¶[0144]).
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fancourt and Brokaw as applied to claim 78 above, and further in view of Rohr et al. (U.S. Patent Application Publication No. 2016/0210679) hereinafter referred to as Rohr.
Regarding claim 90, Fancourt as modified teaches the ear-wearable device of claim 78.
Fancourt as modified does not teach cross-referencing changes in gait with changes in footwear of the device wearer as identified by at least one of signals from the microphone and input from the device wearer.
Attention is drawn to the Rohr reference, which teaches cross-referencing changes in gait with changes in footwear of a device wearer as identified by at least one of signals from a microphone and input from the device wearer (¶¶[0041-0042]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the gait monitoring device of Fancourt as modified to include cross-referencing changes in footwear, as taught by Rohr because it can improve the shoe choice for an individual to avoid injury (Rohr ¶[0050]).
Claim(s) 99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fancourt and Brokaw as applied to claim 1 above, and further in view of Plotnik-Peleg et al. Patent Application Publication No. 2014/0303508) hereinafter referred to as Plotnik.
Regarding claim 99, Fancourt as modified teaches the ear-wearable device of claim 1.
Fancourt as modified does not teach wherein the ear-wearable device is configured to change the audio cues over a period of time to transition from an existing gait to a faster gait.
Attention is drawn to the Plotnik reference, which teaches changing the audio cues over a period of time to transition from an existing gait to a faster gait (¶[0227]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the gait monitoring device of Fancourt as modified to include cues to speed up walking of the user, as taught by Plotnik, because it can overcome, prevent or otherwise ameliorate freezing (Plotnik ¶[0227]).
Claim(s) 12 and 100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fancourt and Brokaw as applied to claims 1 and 11 above, and further in view of Ò Laighin et al. (U.S. Patent Application Publication No. 2018/0140842) hereinafter referred to as Laighin.
Regarding claim 12, Fancourt as modified teaches the ear-wearable device of claim 1.
Fancourt as modified does not teach the detected activity state comprising the device wearer assuming a standing or upright posture.
Attention is brought to the Laighin reference, which teaches detecting a device wearer assuming a standing or upright posture (Fig. 8 and 11-12, state diagrams detecting sit-to-stand transition).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the gait monitoring device of Fancourt as modified to include detecting standing or intent to walk, as taught by Laighin, because it avoids cueing when not desired.
Regarding claim 100, Fancourt as modified teaches the ear-wearable device of claim 1.
Fancourt does not teach wherein the ear-wearable device is configured to detect a sit-to-stand transition of the device wearer and start to deliver audio cues after a standing or upright posture has been reached.
Attention is brought to the Laighin reference, which teaches detecting a sit-to-stand transition of a device wearer and start to deliver audio cues after a standing or upright posture has been reached (Fig. 8 and 11-12, state diagrams detecting sit-to-stand transition).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the gait monitoring device of Fancourt as modified to include detecting standing or intent to walk, as taught by Laighin, because it avoids cueing when not desired.
Claim(s) 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fancourt, Brokaw and Ò Laighin as applied to claim 100 above, and further in view of Stone et al. (U.S. Patent Application Publication No. 2017/0055917) hereinafter referred to as Stone.
Regarding claim 101, Fancourt as modified teaches the ear-wearable device of claim 1.
Fancourt as modified by teaches only providing gait cues when actual intent to walk to beginning walking is detected as in the rejection above. Laighin further teaches at least one sit-to-stand to walking transition where walking cueing is delayed by a person continuing to stand still (Figs. 10-11).
Fancourt as modified does not teach wherein a speed of the sit-to-stand transition crosses a threshold value to trigger the wait time.
Attention is brought to the Stone reference, which teaches wherein a speed of a sit-to-stand transition crosses a threshold value (¶[0065], ¶[0092-0093], and ¶[0085] incorporates additional details of methodology by reference).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the gait monitoring system of Fancourt as modified to include delaying gait cues based on a speed of sit-to-stand, because Stone teaches that delaying walking after an abnormal sit-to-stand can reduce fall risk (Stone ¶[0084]).
Conclusion
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792