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, 8-9, 18, and 20-21 are objected to because of the following informalities:
Claim 1 line 1 should begin as “A cueing device…”;
Claim 1 line 15 should recite “a routine and a non-routine motion” for proper grammar;
Claim 8 line 3 should recite “the user dependent parameter”;
Claim 9 line 3 should include a space between “floor” and “surface”;
Claim 18 line 5 should end in a semicolon “;”;
Claim 20 lines 6-7 should recite ““a routine and non-routine motion” for proper grammar;
Claim 20 line 7 should end in a semicolon “;”;
Claim 21 line 1 should begin as “The method of claim 20…”;
Claim 21 line 1 should include a comma “,” after “20” and a colon “:” after “comprising”.
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.
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: cueing unit in claims 1, 13, 20, and 21.
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.
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, 8, 11-14, 18, and 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "a gait irregularity" in lines 3 and 10 (two instances). This creates confusion as to whether these are the same “gait irregularity” disclosed in line 2 or if they are different gait irregularities. If they are the same, the examiner recommends amending to recite “the gait irregularity”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance. The following claims have similar issue regarding a/the “gait irregularity”:
Claim 2 line 3;
Claim 3 line 2;
Claim 4 line 2;
Claim 11 line 2;
Claim 13 lines 4-5.
Claim 1 recites the limitation "a cue" in line 8. This creates confusion as to whether this is the same “cue” disclosed in line 1 or if it is a different cue. If they are the same, the examiner recommends amending to recite “the cue”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance. The following claims have similar issue regarding a/the “cue”:
Claim 3 line 1;
Claim 4 line 3;
Claim 13 lines 4-5.
Claim 8 recites the limitation "a user dependent parameter" in lines 2 and 3 (two instances). This creates confusion as to whether this is the same “user dependent parameter” disclosed in claim 7 lines 2-3 or if it is a different user dependent parameter. If they are the same, the examiner recommends amending to recite “the user dependent parameter”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 12 recites the limitation "a non-routine motion" in line 2. This creates confusion as to whether this is the same “non-routine motion” disclosed in claim 1 line 15 or if it is a different. If they are the same, the examiner recommends amending to recite “the non-routine motion”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 13 recites the limitation "a cueing unit" in lines 4-5. This creates confusion as to whether this is the same “cueing unit” disclosed in claim 1 line 8 or if it is different. If they are the same, the examiner recommends amending to recite “the cueing unit”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 14 recites the limitation "the cue device" in line 2. There is insufficient antecedent basis for this limitation in the claim. The examiner notes that there are two potential methods to resolve this issue. The first is if a “cue device” is different from the “cueing device”, in which case the examiner recommends changing line 2 to recite “a cue device”. If they are the same, the examiner recommends amending the claim language to “thecueing device”. For purposes of compact prosecution, the examiner is interpreting “the cue device” as the same as previously recited “cueing device”.
Claim 14 recites the limitations "a strap" and “a housing”in lines 2-3. This creates confusion as to whether they are the same “strap” and “housing” disclosed in claim 1 line 3 or if they are different. If they are the same, the examiner recommends amending to recite “the strap” and “the housing”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 18 recites the limitation "a gait irregularity" in lines 9 and 11 (two instances). This creates confusion as to whether these are the same “gait irregularity” disclosed in line 2 or if they are different gait irregularities. If they are the same, the examiner recommends amending to recite “the gait irregularity”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 18 recites the limitation "a cue" in line 10. This creates confusion as to whether this is the same “cue” disclosed in line 2 or if it is different. If they are the same, the examiner recommends amending to recite “the cue”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 20 recites the limitation "the cueing device” in lines 4, 6, 8, 10-11, and 12 (five instances). This creates confusion as to whether these are the same as the aforementioned “wearable cueing device” disclosed in line 3 or if they are different. If they are the same, the examiner recommends amending to recite “the wearable cueing device”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance. Claim 21 lines 2-3 and 4 have the same antecedent basis issue as mentioned above regarding “the cueing device”.
Claim 20 recites the limitation "a gait irregularity" in lines 11 and 13 (two instances). This creates confusion as to whether these are the same “gait irregularity” disclosed in line 9 or if they are different gait irregularities. If they are the same, the examiner recommends amending to recite “the gait irregularity”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 21 the limitations "a first algorithm" and “a first outcome” in line 5-6. This creates confusion as to whether they are the same “first algorithm” and “first outcome” disclosed in claim 20 lines 8-9 or if they are different. If they are the same, the examiner recommends amending to recite “the first algorithm” and “the first outcome”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 21 recites the limitation "a gait irregularity" in lines 6, 11, and 14 (three instances). This creates confusion as to whether these are the same “gait irregularity” disclosed in claim 20 line 9 or if they are different gait irregularities. If they are the same, the examiner recommends amending to recite “the gait irregularity”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 21 recites the limitation "a motion sensor" in line 7. This creates confusion as to whether this is the same “motion sensor” disclosed in claim 20 line 4 or if it is different. If they are the same, the examiner recommends amending to recite “the motion sensor”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 21 recites the limitation "a received sensor signal" in line 8. This creates confusion as to whether this is the same “sensor signal” disclosed in claim 20 line 4 or if it is different. If they are the same, the examiner recommends amending to recite “the received sensor signal”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 21 recites the limitation "a cue" in lines 9 and 13 (two instances). This creates confusion as to whether these are the same “cue” disclosed in claim 20 line 12 or if they are different. If they are the same, the examiner recommends amending to recite “the cue”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 21 recites the limitations "a second algorithm" and “a second outcome” in line 10. This creates confusion as to whether these are the same “second algorithm” and “second outcome” disclosed in claim 20 lines 10-11 or if they are different. If they are the same, the examiner recommends amending to recite “the second algorithm” and “the second outcome”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 21 recites the limitation "a routine algorithm" in line 15. This creates confusion as to whether this is the same “routine algorithm” disclosed in claim 20 line 6 or if it is different. If they are the same, the examiner recommends amending to recite “the routine algorithm”. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim 21 recites the limitations "a routine or non-routine motion" in lines 15-16. This creates confusion as to whether this is the same “routine or non-routine motion” disclosed in claim 20 line 6-7 or if it is different. If they are the same, the examiner recommends amending to recite “the routine and the non-routine motion”, which also provides correct grammar. If they are different, there is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, they are being interpreted as the same as the preceding instance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-2, 14, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Marsh (US 10251611 B2) in view of Sio (US 20180289287 A1) and Yu (US 10242590 B2).
Regarding claim 1, Marsh teaches a Cueing device for producing a cue for assisting a user during a motion when a gait irregularity is determined, wherein the cueing device comprises:
a housing [Fig 1 Item 11] and a strap [Fig. 4 Item 21] to wear the cueing device [Fig. 4 Item 10];
a control unit [Fig. 3 Item 100] situated in the housing [col. 5 lns. 11-14 “The apparatus 10 has a housing 11 that contains electronics (shown in FIG. 3) including at least a processor 100, a motion sensor 110…”], which is programmed by a first algorithm providing a first outcome to determine a gait irregularity, in particular a freeze of gait (FoG), during the motion [col. 5 lns. 56-58 “The processor 100 then uses a gait analysis algorithm to differentiate between normal walking and a gait irregularity such as a freeze of gait (FOG)”];
a motion sensor [Fig. 3 Item 110] situated in the housing operatively connected to the control unit [col. 5 lns. 11-14 “The apparatus 10 has a housing 11 that contains electronics (shown in FIG. 3) including at least a processor 100, a motion sensor 110…”], to obtain motion data based on a received sensor signal [col. 2 lns. 66-67—col. 3 lns. 1-2 “The microcontroller is preferably programmed to analyse at least one signal from the at least one motion sensor connected to an input of the microcontroller”]; and
a cueing unit [Fig. 3 Item 120] operatively connected to the control unit [see Fig. 3] to provide a cue to the user [col. 5 lns. 63-65 “If a gait irregularity is determined (at 220) then the light source, laser 120, is activated (step 230)”], wherein the control unit is further programmed by a routine algorithm which is configured to distinguish between a routine or a non-routine motion of the user [col. 5 lns. 56-58 “The processor 100 then uses a gait analysis algorithm to differentiate between normal walking and a gait irregularity such as a freeze of gait (FOG)”].
Marsh teaches an algorithm that determines gait irregularity and distinguishing between routine and a non-routine motion of the user and using a motion sensor with motion data to aid in the determination and produce a cue when the algorithm indicates gait irregularity, but fails to teach the use of multiple algorithms.
Sio teaches the use of multiple algorithms to determine gait irregularity [0025 “This can be realized, for instance, by means of (an) algorithm(s) that is/are able to analyze, e.g., by means of statistical methods, the available information and that construct(s) the cue set sequence based on the outcome of the analysis”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Marsh and incorporate the teachings of Sio to include the use of multiple algorithms to determine gait irregularity. Doing so configures the system to “…upgrade and improve the treatment apparatus, for instance, when more (a) efficient and reliable algorithm(s) for detecting and/or monitoring the gait irregularity become available or when new knowledge about the suitability of certain cues becomes available”, as recognized by Sio par. 0034.
Marsh teaches a housing and a strap to wear the cueing device, but fails to explicitly teach the cueing device is worn at a user’s lower extremity.
Yu teaches the device [Fig. 2 Item 1] is worn at a user’s lower extremity [see Fig. 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Yu to include the cueing device is worn at a user’s lower extremity. Doing so configures the system to ensure “…the stepping prompt point can be effectively formed on the ground where the front stepping point of the opposite side leg according to the user's gait cycle and gait tread”, as recognized by Yu col. 7 lns. 41-44.
Regarding claim 2, Marsh, Sio, and Yu teach the cueing device according to claim 1, wherein the control unit [Marsh Fig. 3 Item 100] is programmed with at least three different algorithms to provide at least three outcomes to determine a gait irregularity [Sio 0025 “This can be realized, for instance, by means of (an) algorithm(s) that is/are able to analyze, e.g., by means of statistical methods, the available information and that construct(s) the cue set sequence based on the outcome of the analysis”, the examiner notes it is obvious the multiple algorithms of Sio would obviously come to outcomes, see Sio par. 0037 “…upgrade and improve the treatment apparatus, for instance, when more (a) efficient and reliable algorithm(s) for detecting and/or monitoring the gait irregularity become available or when new knowledge about the suitability of certain cues becomes available”].
Regarding claim 3, Marsh, Sio, and Yu teach the cueing device according to claim 1, wherein a cue is only provided if all outcomes of the algorithms positively indicate for a gait irregularity [this is obvious over the combination of Marsh and Sio, wherein the multiple algorithms provide outcomes/conclusions that indicate gait irregularity, see Marsh col. 5 lns. 56-58 “The processor 100 then uses a gait analysis algorithm to differentiate between normal walking and a gait irregularity such as a freeze of gait (FOG)”, Sio par. 0037 “…upgrade and improve the treatment apparatus, for instance, when more (a) efficient and reliable algorithm(s) for detecting and/or monitoring the gait irregularity become available or when new knowledge about the suitability of certain cues becomes available”].
Regarding claim 11, Marsh, Sio, and Yu teach the cueing device according to claim 1, wherein the routine algorithm is carried out before running any of the algorithms to determine a gait irregularity [This is intended use of the claimed invention. The “routine algorithm”, as taught by Marsh in col. 5 lns. 56-58, would be capable of executing its function prior to executing additional algorithms.]
Regarding claim 14, Marsh, Sio, and Yu teach the cueing device according to claim 1, wherein the cue device is a wearable cueing device [see Marsh Fig. 4], wherein the cueing device comprises a strap [Marsh Fig. 4 Item 21] and a housing [Marsh Fig. 1 Item 11] for housing the motion sensor [Marsh col. 5 lns. 11-14 “The apparatus 10 has a housing 11 that contains electronics (shown in FIG. 3) including at least a processor 100, a motion sensor 110…”] which housing is connected to the strap [see Marsh Fig. 5].
Regarding claim 20, Marsh, Sio, and Yu teach a method for treating a person suffering from a motor disorder of neurological origin by preventing freezing of gait comprising the steps of:
attaching a wearable cueing device [Fig. 4 Item 10] onto a person [see Fig. 4];
receiving a sensor signal from a motion sensor [Fig. 3 Item 110, see also col. 2 lns. 66-67—col. 3 lns. 1-2 “The microcontroller is preferably programmed to analyse at least one signal from the at least one motion sensor connected to an input of the microcontroller”] of the cueing device [Fig. 4 Item 10];
acquiring motion data based on the received sensor signal [col. 2 lns. 66-67—col. 3 lns. 1-2];
running a routine algorithm to distinguish between a routine or non-routine motion of the user [col. 5 lns. 56-58 “The processor 100 then uses a gait analysis algorithm to differentiate between normal walking and a gait irregularity such as a freeze of gait (FOG)”];
running an algorithm on the motion data providing a first outcome to determine a gait irregularity [col. 5 lns. 56-58];
providing a cue if the algorithm indicates a determination of a gait irregularity [col. 5 lns. 63-65 “If a gait irregularity is determined (at 220) then the light source, laser 120, is activated (step 230)”].
Marsh teaches an algorithm that determines gait irregularity and distinguishing between routine and a non-routine motion of the user and using a motion sensor with motion data to aid in the determination and produce a cue when the algorithm indicates gait irregularity, but fails to teach the use of multiple algorithms.
Sio teaches the use of multiple algorithms to determine gait irregularity [0025 “This can be realized, for instance, by means of (an) algorithm(s) that is/are able to analyze, e.g., by means of statistical methods, the available information and that construct(s) the cue set sequence based on the outcome of the analysis”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Marsh and incorporate the teachings of Sio to include the use of multiple algorithms to determine gait irregularity. Doing so configures the system to “…upgrade and improve the treatment apparatus, for instance, when more (a) efficient and reliable algorithm(s) for detecting and/or monitoring the gait irregularity become available or when new knowledge about the suitability of certain cues becomes available”, as recognized by Sio par. 0034.
Marsh teaches a housing and a strap to wear the cueing device, but fails to explicitly teach the cueing device is worn at a user’s lower extremity.
Yu teaches the device [Fig. 2 Item 1] is worn at a user’s lower extremity [see Fig. 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Yu to include the cueing device is worn at a user’s lower extremity. Doing so configures the system to ensure “…the stepping prompt point can be effectively formed on the ground where the front stepping point of the opposite side leg according to the user's gait cycle and gait tread”, as recognized by Yu col. 7 lns. 41-44.
Regarding claim 21, Marsh, Sio, and Yu teach the method according to claim 20 comprising a step of attaching the cueing device on a predetermined location at a user's leg, optionally at a peroneus compartment [see Yu Fig. 2], wherein the cueing device comprises:
a housing [Marsh Fig. 4 Item 10] and a strap [Marsh Fig. 4 Item 21] to wear the cueing device at a user's lower extremity [Yu Fig. 2];
a control unit [Marsh Fig. 3 Item 100] situated in the housing [Marsh col. 5 lns. 11-14 “The apparatus 10 has a housing 11 that contains electronics (shown in FIG. 3) including at least a processor 100, a motion sensor 110…”] which is programmed by a first algorithm providing a first outcome to determine a gait irregularity, in particular a freeze of gait (FoG), during the motion [Marsh col. 5 lns. 56-58 “The processor 100 then uses a gait analysis algorithm to differentiate between normal walking and a gait irregularity such as a freeze of gait (FOG)”];
a motion sensor [Marsh Fig. 3 Item 110] situated in the housing operatively connected to the control unit [Marsh col. 5 lns. 11-14 “The apparatus 10 has a housing 11 that contains electronics (shown in FIG. 3) including at least a processor 100, a motion sensor 110…”], to obtain motion data based on a received sensor signal [Marsh col. 2 lns. 66-67—col. 3 lns. 1-2 “The microcontroller is preferably programmed to analyse at least one signal from the at least one motion sensor connected to an input of the microcontroller”]; and
a cueing unit [Fig. 3 Item 120] operatively connected to the control unit [see Marsh Fig. 3] to provide a cue to the user [Marsh col. 5 lns. 63-65 “If a gait irregularity is determined (at 220) then the light source, laser 120, is activated (step 230)”], wherein the control unit is further programmed by a routine algorithm which is configured to distinguish between a routine or a non- routine motion of the user [Marsh col. 5 lns. 56-58 “The processor 100 then uses a gait analysis algorithm to differentiate between normal walking and a gait irregularity such as a freeze of gait (FOG)”].
Machanian teaches an algorithm based on a user profile including at least one user dependent parameter [0233 “The database will also store clinical data regarding pathological patterns and potential risks which will be provided to the AI algorithm to search for according to patient's demographic and/or clinical data such as BMI and/or DFU history and/or foot conditions (e.g. flat foot or pronation) and/or lower limb conditions”].
Yu teaches the device [Fig. 2 Item 1] is worn at a user’s lower extremity [see Fig. 2].
Regarding claim 22, Marsh, Sio, and Yu teach a computer program product comprising a computer readable medium [Marsh col. 3 lns. 32-33], the computer readable medium having computer readable code embodied therein [Sio 0056 “…a computer program for controlling a treatment apparatus for treating a gait irregularity of a person is presented…”], the computer readable code being configured such that, on execution by a suitable computer or processor, the computer or processor is caused to perform the method according to claim 21 [see claim 21 rejection above].
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Marsh, Sio, and Yu as applied to claim 1 above, and further in view of Machanian (US 20230354952 A1).
Regarding claim 7, Marsh, Sio, and Yu teach the cueing device according to claim 7, wherein the combination of Marsh and Sio teach the use of multiple algorithms to determine gait irregularity, but fail to explicitly teach at least one algorithm is based on a user profile including at least one user dependent parameter.
Machanian teaches an algorithm based on a user profile including at least one user dependent parameter [0233 “The database will also store clinical data regarding pathological patterns and potential risks which will be provided to the AI algorithm to search for according to patient's demographic and/or clinical data such as BMI and/or DFU history and/or foot conditions (e.g. flat foot or pronation) and/or lower limb conditions”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Marsh, Sio, and Yu and incorporate the teachings of Machanian to include an algorithm based on a user profile including at least one user dependent parameter. Doing so configures the system to “…quickly recommend a treatment plan with a high success probability”, as recognized by Machanian par. 0233.
Regarding claim 8, Marsh, Sio, Yu, and Machanian teach the cueing device according to claim 7, wherein at least one of the algorithms is distinguished from another algorithm by including a user dependent parameter, for example a BMI or body length [Machanian 0233 “The database will also store clinical data regarding pathological patterns and potential risks which will be provided to the AI algorithm to search for according to patient's demographic and/or clinical data such as BMI and/or DFU history and/or foot conditions (e.g. flat foot or pronation) and/or lower limb conditions”], while the other algorithm lacks a user dependent parameter [The teachings of Sio disclose using multiple algorithms, and the algorithms as taught by the combination of Marsh and Sio appear to lack user dependent parameters. Thus, the algorithm taught in Marsh and the algorithm taught by Machanian would be distinguishable from one another by a user dependent parameter].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Marsh, Sio, and Yu as applied to claim 1 above, and further in view of Embrechts (US 20220179933 A1).
Regarding claim 9, Marsh, Sio, and Yu teach the cueing device according to claim 1, wherein the combination of Marsh and Sio teach the use of multiple algorithms to determine gait irregularity, but fail to explicitly teach at least one algorithm includes an environmental parameter, for example a hard or soft floorsurface or a shoe type.
Embrechts teaches the algorithm includes an environmental parameter, for example a hard or soft floorsurface or a shoe type [0063 “…an algorithm may automatically detect a type of shoes worn by user”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachigns of Marsh, Sio, and Yu and incorporate the teachings of Embrechts to include the algorithm includes an environmental parameter, for example a hard or soft floorsurface or a shoe type. Doing so configures the system to “load a specific model” tailored to a specific type of environmental factor that aid in more accurate predictions based on the adjusted model, as recognized by Embrechts par. 0063.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Marsh, Sio, and Yu as applied to claim 1 above, and further in view of Naveh (US 20200289027 A1) and Elyada (WO 2019086997 A2).
Regarding claim 13, Marsh, Sio, and Yu teach the cueing device according to claim 1, wherein Marsh teaches a cueing device, producing a cue indicating gait irregularity, a motion sensor, and peripheral devices [Marsh Fig. 3 Item 140], but fails to explicitly teach the cueing device is formed by a system including a smart phone and a smart watch which are provided with cooperating apps and in which the smartphone houses the at least one motion sensor to obtain motion data of the user, and in which the smartwatch serves as a cueing unit to produce a cue to the user in case of a gait irregularity.
Naveh teaches the smartphone houses the at least one motion sensor to obtain motion data of the user [0113 “Modem smart devices, e.g. smartphones, boast a winning combination of motion sensors based on magneto-inertial technology and computation power, and are ubiquitous. Given the fact that end-users have their phones with them almost every day, almost all day long, this combination may be harnessed to provide a continuous gait monitoring system, including analysis”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Marsh, Sio, and Yu and incorporate the teachings of Naveh to include the smartphone houses the at least one motion sensor to obtain motion data of the user. Doing so configures the system to use a commonly used device that can provide “continuous gait monitoring” for “tracking gait trends”, as recognized by Naveh par. 0113.
Elyada teaches the smartwatch serves as a cueing unit to produce a cue to the user [00185 “Whenever gait is determined by a SENSOR UNIT to require a con-ective action, an audiovisual sensory cue is provided to the subject via said OUTPUT UNIT. [00186] Additionally, this embodiment includes a smartwatch 22 OUTPUT UNIT…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Marsh, Sio, and Yu and incorporate the teachings of Elyada to include the smartwatch serves as a cueing unit to produce a cue to the user. Doing so configures the system to provide the cue to an accessible device that can provide real-time, multimodal cue delivery that can be integrated into daily life with little to no intrusiveness to the user.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Marsh in view of Sio.
Regarding claim 18, Marsh teaches a computer-implemented control method for controlling a cueing device configured to provide a cue during a motion of a user, the control method comprising:
receiving a sensor signal from a motion sensor [Fig. 3 Item 110, see also col. 2 lns. 66-67—col. 3 lns. 1-2 “The microcontroller is preferably programmed to analyse at least one signal from the at least one motion sensor connected to an input of the microcontroller”];
acquiring motion data based on the received sensor signal [col. 2 lns. 66-67—col. 3 lns. 1-2];
running a routine algorithm to distinguish between a routine or non-routine motion of the user [col. 5 lns. 56-58 “The processor 100 then uses a gait analysis algorithm to differentiate between normal walking and a gait irregularity such as a freeze of gait (FOG)”];
running an algorithm on the motion data providing a first outcome to determine a gait irregularity [col. 5 lns. 56-58];
providing a cue if the algorithm indicates a determination of a gait irregularity [col. 5 lns. 63-65 “If a gait irregularity is determined (at 220) then the light source, laser 120, is activated (step 230)”].
Marsh teaches an algorithm that determines gait irregularity and distinguishing between routine and a non-routine motion of the user and using a motion sensor with motion data to aid in the determination and produce a cue when the algorithm indicates gait irregularity, but fails to teach the use of multiple algorithms.
Sio teaches the use of multiple algorithms to determine gait irregularity [0025 “This can be realized, for instance, by means of (an) algorithm(s) that is/are able to analyze, e.g., by means of statistical methods, the available information and that construct(s) the cue set sequence based on the outcome of the analysis”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Marsh and incorporate the teachings of Sio to include the use of multiple algorithms to determine gait irregularity. Doing so configures the system to “…upgrade and improve the treatment apparatus, for instance, when more (a) efficient and reliable algorithm(s) for detecting and/or monitoring the gait irregularity become available or when new knowledge about the suitability of certain cues becomes available”, as recognized by Sio par. 0034.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN M HANEY/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791