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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Examiner’s Note Regarding Machine Learning: the claimed predictive model (i.e., machine learning) of claims 3, 10, and 17 was considered under § 112(a), wherein the Examiner notes that the disclosure of the trained predictive model (see specification ¶[0046]) of the Applicant’s Specification is considered to provide sufficient written description support for the predictive model as presently claimed for one of ordinary skill in the art to understand that the Applicant possessed the instant invention at the time of filing.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “analyzing the linear portion data and the turn portion data to calculate one or more gait parameters for the user” in lines 7-8. This is clearly computer-implemented recitation. See claim 1, line 1, and the specification ¶[0021]-[0036]; Figs. 1-2.
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 1, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the analysis process (i.e., the determining of the parameters from the linear portion data and the turn portion data). The specification merely details that the parameters may include stride speed, stride length, turn speed, and steps per turn (see specification ¶[0046] and ¶[0059]). The disclosure provides no algorithm, flow chart, or other detailed description of the analysis process itself, but only refers to the analysis process in a “black box” description, meaning that analysis process is referred to in a general sense but the specifics of the analysis process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention, especially since it appears that the analysis process is one of central features of the claimed invention.
Claims 2-7 are rejected by virtue of their dependence from claim 1.
Claim 8 recites “analyze the linear portion data and the turn portion data to calculate one or more gait parameters for the user” in lines 10-11. This is clearly computer-implemented recitation. See claim 8, lines 1-4, and the specification ¶[0021]-[0036]; Figs. 1-2.
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 8, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the analysis process (i.e., the determining of the parameters from the linear portion data and the turn portion data). The specification merely details that the parameters may include stride speed, stride length, turn speed, and steps per turn (see specification ¶[0046] and ¶[0059]). The disclosure provides no algorithm, flow chart, or other detailed description of the analysis process itself, but only refers to the analysis process in a “black box” description, meaning that analysis process is referred to in a general sense but the specifics of the analysis process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention, especially since it appears that the analysis process is one of central features of the claimed invention.
Claims 9-14 are rejected by virtue of their dependence from claim 8.
Claim 15 recites “analyze the linear portion data and the turn portion data to calculate one or more gait parameters for the user” in lines 10-11. This is clearly computer-implemented recitation. See claim 15, lines 1-4, and the specification ¶[0021]-[0036]; Figs. 1-2.
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 15, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the analysis process (i.e., the determining of the parameters from the linear portion data and the turn portion data). The specification merely details that the parameters may include stride speed, stride length, turn speed, and steps per turn (see specification ¶[0046] and ¶[0059]). The disclosure provides no algorithm, flow chart, or other detailed description of the analysis process itself, but only refers to the analysis process in a “black box” description, meaning that analysis process is referred to in a general sense but the specifics of the analysis process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention, especially since it appears that the analysis process is one of central features of the claimed invention.
Claims 16-20 are rejected by virtue of their dependence from claim 8.
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 5, 12, and 19 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 5 recites “a turn start time” in line 7, but it is not clear if this recitation is the same as, related to, or different from the recitation “a turn start time” in line 6. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the turn start time”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 5 recites “a turn stop time” in line 7, but it is not clear if this recitation is the same as, related to, or different from the recitation “a turn stop time” in line 6. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the turn stop time”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 12 recites “a turn start time” in line 7, but it is not clear if this recitation is the same as, related to, or different from the recitation “a turn start time” in line 6. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the turn start time”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 12 recites “a turn stop time” in line 7, but it is not clear if this recitation is the same as, related to, or different from the recitation “a turn stop time” in line 6. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the turn stop time”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 19 recites “a turn start time” in line 8, but it is not clear if this recitation is the same as, related to, or different from the recitation “a turn start time” in line 7. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the turn start time”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 19 recites “a turn stop time” in line 8, but it is not clear if this recitation is the same as, related to, or different from the recitation “a turn stop time” in line 7. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the turn stop time”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
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 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. The recitation "one or more computer readable storage media" in line 2 can encompass non-statutory forms of signal transmission, such as, a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the broadest reasonable interpretation of machine readable media encompasses transitory forms of signal transmission, the claim is directed to non-statutory subject matter. It is suggested that Applicant amend the claim to recite "one or more non-transitory computer readable storage media” in order to recite statutory subject matter.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards abstract ideas without significantly more.
Claim 1 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “analyzing the gyroscope data to identify one or more turns in the ambulation test” (see specification ¶[0040]-[0043]) is being interpreted as mathematical calculations/evaluations and/or judgements/observations (i.e., a human making judgements/observations from the data). The recitation “segmenting the gyroscope data, based on the identified one or more turns, into linear portion data and turn portion data” (see specification ¶[0044]-[0045]) is being interpreted as mathematical calculations/evaluations and/or judgements/observations (i.e., a human making judgements/observations from the data). The recitation “analyzing the linear portion data and the turn portion data to calculate one or more gait parameters for the user” (see specification ¶[0046] and ¶[0059], as best understood in view of the 35 U.S.C. § 112 rejection above) is being interpreted as mathematical calculations/evaluations (i.e., a human making judgements/observations from the data). The recitations are computer-implemented, as indicated in claim 1, line 1; and as indicated in the specification (see specification ¶[0021]-[0036]; Figs. 1-2).
Claim 8 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “analyze the gyroscope data to identify one or more turns in the ambulation test” (see specification ¶[0040]-[0043]) is being interpreted as mathematical calculations/evaluations and/or judgements/observations (i.e., a human making judgements/observations from the data). The recitation “segment the gyroscope data, based on the identified one or more turns, into linear portion data and turn portion data” (see specification ¶[0044]-[0045]) is being interpreted as mathematical calculations/evaluations and/or judgements/observations (i.e., a human making judgements/observations from the data). The recitation “analyze the linear portion data and the turn portion data to calculate one or more gait parameters for the user” (see specification ¶[0046] and ¶[0059], as best understood in view of the 35 U.S.C. § 112 rejection above) is being interpreted as mathematical calculations/evaluations (i.e., a human making judgements/observations from the data). The recitations are computer-implemented, as indicated in claim 8, lines 1-4; and as indicated in the specification (see specification ¶[0021]-[0036]; Figs. 1-2).
Claim 15 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “analyze the gyroscope data to identify one or more turns in the ambulation test” (see specification ¶[0040]-[0043]) is being interpreted as mathematical calculations/evaluations and/or judgements/observations (i.e., a human making judgements/observations from the data). The recitation “segment the gyroscope data, based on the identified one or more turns, into linear portion data and turn portion data” (see specification ¶[0044]-[0045]) is being interpreted as mathematical calculations/evaluations and/or judgements/observations (i.e., a human making judgements/observations from the data). The recitation “analyze the linear portion data and the turn portion data to calculate one or more gait parameters for the user” (see specification ¶[0046] and ¶[0059], as best understood in view of the 35 U.S.C. § 112 rejection above) is being interpreted as mathematical calculations/evaluations (i.e., a human making judgements/observations from the data). The recitations are computer-implemented, as indicated in claim 15, lines 1-4; and as indicated in the specification (see specification ¶[0021]-[0036]; Figs. 1-2).
Step 1: This part of eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claim 1 recites a method, which is directed towards a process (a statutory category of invention). Claims 8 and 15 recite a system and program product, respectively, which are directed towards a machine/manufacture (a statutory category of invention). Step 1: YES.
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(a)(2)(III). The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgements, and opinions. As discussed in the claim interpretation section, the limitations include, under the BRI, multiple mathematical calculations/evaluations and judgements/observations of the data. Accordingly, the limitations as seen in claims 1, 8, and 15 recite judicial exceptions (abstract ideas that fall within the mental process grouping). No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Furthermore, as explained in MPEP 2106.04(a)(2)(I). The courts consider mathematical calculations, when the claim is given its BRI in light of the specification, as falling within the “mathematical concept” grouping of abstract ideas. A claim does not have to recite “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using a mathematical method, or “performing” a mathematical operation, may also be considered a mathematical calculation when the BRI of the claim in light of the specification encompasses a mathematical calculation. As discussed in the claim interpretation section, the limitations include, under the BRI, multiple mathematical calculations/evaluations. Accordingly, the limitations as seen in claims 1, 8, and 15 recite judicial exceptions (abstract ideas that fall within the mathematical calculations grouping of mathematical concepts).
Alternatively or additionally, these steps describe the concept of using implicit mathematical formulas (i.e., calculations to determine a likelihood score) to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts (Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
In particular, claim 1 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
a method of analyzing gait of patients comprising:
obtaining gyroscope data from a mobile device associated with a body of a user while the user performs an ambulation test;
analyzing the gyroscope data to identify one or more turns in the ambulation test;
segmenting the gyroscope data, based on the identified one or more turns, into linear portion data and turn portion data; and
analyzing the linear portion data and the turn portion data to calculate one or more gait parameters for the user.
Furthermore, claim 8 recites the elements, which are part of the abstract idea (i.e., the algorithm):
analyzing gait of patients, comprising:
obtain gyroscope data from a mobile device associated with a body of a user while the user performs an ambulation test;
analyze the gyroscope data to identify one or more turns in the ambulation test;
segment the gyroscope data, based on the identified one or more turns, into linear portion data and turn portion data; and
analyze the linear portion data and the turn portion data to calculate one or more gait parameters for the user.
In addition, claim 15 recites the elements, which are part of the abstract idea (i.e., the algorithm):
analyzing gait of patients, to:
obtain gyroscope data from a mobile device associated with a body of a user while the user performs an ambulation test;
analyze the gyroscope data to identify one or more turns in the ambulation test;
segment the gyroscope data, based on the identified one or more turns, into linear portion data and turn portion data; and
analyze the linear portion data and the turn portion data to calculate one or more gait parameters for the user.
Step 2A Prong One: YES.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the judicial exceptions into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exceptions, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exceptions into a practical application. Claims 1, 8, and 15 recite elements directed towards a generic computer (i.e., the computer, processor, memory, storage media, computer program product, etc.). Note that claims 1, 8, and 15 do not positively recite the mobile device; rather, the generic computer merely obtains/receives the data. This is insignificant extra-solution activity (i.e., pre-solution activity) well known in the art, and recited at a high level of generality, see MPEP 2106.05(g). Therefore, the method/devices are merely instructions to implement an abstract idea on a generic computer or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2A Prong Two: NO.
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with Step 2A Prong Two, claims 1, 8, and 15 recite elements directed towards a generic computer (i.e., the computer, processor, memory, storage media, computer program product, etc.). The method/devices utilizing a generic computer do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no
indication that the combination of elements improves the functioning of a computer, for
example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is
no indication that the combination of elements includes a particular solution to a computer-based
problem or a particular way to achieve a desired computer-based outcome. Rather, the collective
functions of the claimed invention merely provide conventional computer implementation, i.e.,
the computer is simply a tool to perform the process. Step 2B: NO.
Claims 1, 8, and 15 are not eligible.
Claims 2-7, 9-14, and 16-20 depend from claims 1, 8, and 15, respectively, and merely further define the abstract ideas of claims 1, 8, and 15. The claims recite no additional element that integrates the judicial exceptions into a practical application. The claims recite no additional element that adds an inventive concept to the claim and/or amounts to significantly more than the recited exception. The method/devices utilizing a generic computer do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Furthermore, claims 2, 9, and 16 recite the additional element of indicating a treatment. A claim that recites a particular treatment or prophylaxis “meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. See MPEP § 2106.04(d)(2). In order to qualify as a “treatment” or “prophylaxis", the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used. Furthermore, the treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). In this case, a treatment is merely indicating, but there is no application. Therefore, this claimed element cannot be seen as integration into a practical application.
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.
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.
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, 8-9, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over DeMers et al. (US Patent Application Publication 2021/0393166 – cited by Applicant), hereinafter DeMers, and in view of Armitage et al. (US Patent Application Publication 2022/0254492), hereinafter Armitage.
Regarding Claims 1, 8, and 15, DeMers teaches a method in which a computing device obtains sensor data from one or more accelerometers and one or more gyroscopes over a time period, and based on portions of the data identified, determines gait parameters (see abstract and Figs. 1-3). DeMers teaches a computer-implemented method of analyzing gait of patients (see abstract and Figs. 1-3; see also ¶[0004] and ¶[0040]-[0042], the mobile device 100 may be a mobile phone),
a computer system for analyzing gait of patients (see abstract and Figs. 1-3; see also ¶[0004] and ¶[0040]-[0042], the mobile device 100 may be a mobile phone),
a computer program product for analyzing gait of patients, the computer program product comprising one or more computer readable storage media having program instructions collectively stored on the one or more computer readable storage media, the program instructions executable by at least one processor (¶[0004] and ¶[0040]-[0042], the mobile device 100 including memory 150 and one or more processors 104/152, ¶[0055] the instructions/applications may be implemented as software programs stored on the memory 150 for execution by the one or more processors 104/152; Fig. 1),
comprising:
one or more memories (¶[0004] and ¶[0040]-[0042], the mobile device 100 including the memory 150; Fig. 1); and at least one processor coupled to the one or more memories (¶[0004] and ¶[0040]-[0042], the mobile device 100 including the one or more processors 104/152; Fig. 1), wherein the at least one processor is configured to:
obtain gyroscope data (¶[0042]-[0043] the motion sensors 110 of the mobile device 100, including an accelerometer for acceleration data and a gyroscope for orientation data; note, the specification of the present application ¶[0068] details that the gyroscope data may include angular velocities, accelerations, orientations, changes in orientations, etc.) from a mobile device associated with a body of a user (¶[0042]-[0043] the one or more processors 104/152 obtain the sensor data for further analysis; Fig. 1) while the user’s health is monitored (¶[0057]-[0058], ¶[0085]-[0087], and ¶[0095] the mobile device may monitor and identify a health condition based off of the gait factors/values, such as the onset/lack of Parkinson’s disease);
analyze the gyroscope data to identify one or more turns (¶[0056], ¶[0085]-[0086], and ¶[0130] multiple characteristics of the user’s gait may be determined, including a turning rate/speed, indicating that turns are identified/evaluated);
segment the gyroscope data (¶[0098] and ¶[0138] the mobile device 100 may segment the sensor data into different positions, such as by gait phase; Fig. 7A); and
analyze the linear portion data and the turn portion data to calculate one or more gait parameters for the user (¶[0056], ¶[0085]-[0086], and ¶[0130] multiple characteristics of the user’s gait may be determined, including a turning rate/speed, indicating that turns are identified/evaluated, ¶[0118]-[0121] the characteristics may also include average step speed, and ¶[0130] step length, which may also be determined for a stride).
DeMers teaches that a turning rate/speed characteristic and average step speed and length are determined from the senor data (see ¶[0056], ¶[0085]-[0086], ¶[0118]-[0121], and ¶[0130]), indicating that the sensor data is segmented, at least based on turn portions and walking portions.
DeMers does not specifically teach that the user performs an ambulation test, and subsequent data identified from such a test.
Armitage teaches systems, apparatus, and methods for automatically detecting and/or estimating one or more clinical biomarkers of a subject (see abstract and Fig. 1A), in which the biomarkers include the subject turning and the subject walking (see ¶[0053] and ¶[0159]-[0160]), in which the biomarkers, including the walk segment 306c and the turn segment 306d, may be extracted/segmented from the sensor data, in which the segments are identified/extracted from when the subject is performing motions associated with a timed up and go (TUG) test (see ¶[0161]-[0165]; Fig. 3A), in which the sensor data may be collected when the subject performs specialist tests (i.e., a TUG tests) under direction of a clinician or during everyday activities (see ¶[0123]). Note that the walking in Armitage is linear, as indicated by TUG test, which involves standing from a chair, walking linearly and turning 180 degrees, then walking back to the chair before sitting down again (see for example “Timed Up and Go Test (TUG)”, Physiopedia, accessed on February 19, 2026, accessed at https://www.physio-pedia.com/Timed_Up_and_Go_Test_(TUG), pg. 2, § Method). Furthermore, the ambulation test (genus) of the present claim is read upon by the TUG test (species) of Armitage, as the ambulation test of the present application merely requires linear portions and turns (see specification ¶[0011]). Also note that such limitations are not presently recited in the independent claims.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the extraction/segmentation of the data during TUG test motions, including the linear walking and turning segments, of the subject as taught in Armitage for the segmentation for gait characteristics in the gait monitoring of the user in DeMers because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; and/or (2) DeMers requires segmentation of the data into portions for determination of the gait characteristics and Armitage teaches one such segmentation; and/or (3) DeMers contemplates monitoring subjects for onset/lack of diseases, such as Parkinson’s disease (see DeMers ¶[0057]-[0058], ¶[0085]-[0087], and ¶[0095]), and Armitage teaches one such test (i.e., TUG test) and extraction/segmentation known to be highly reliable in patients with Parkinson’s disease (see for example “Timed Up and Go Test (TUG)”, Physiopedia, accessed on February 19, 2026, accessed at https://www.physio-pedia.com/Timed_Up_and_Go_Test_(TUG), pg. 3-4, § Parkinson’s Disease); and/or (4) the user performing the TUG test would help a medical professional provide appropriate care to the user.
Regarding Claims 2, 9, and 16, DeMers in view of Armitage teaches the method/devices of claims 1, 8, and 15, respectively, as stated above. The modified DeMers further teaches determining that the user has a medical condition based on the one or more gait parameters (see DeMers ¶[0057]-[0058], ¶[0085]-[0087], and ¶[0095], the mobile device may monitor and identify a health condition based off of the gait factors/values, such as the onset/lack of Parkinson’s disease; see Armitage ¶[0161]-[0165], the biomarkers, including the walk segment 306c and the turn segment 306d, may be extracted/segmented from the sensor data, in which the segments are identified/extracted from when the subject is performing motions associated with the TUG test, ¶[0123] the sensor data may be collected when the subject performs specialist tests (i.e., a TUG tests) under direction of a clinician or during everyday activities, Fig. 3A); and
indicating a treatment for the medical condition (see DeMers ¶[0057]-[0058] the information may be presented to the user and/or others to assist in caring for the user, such as for administering medical treatment, ¶[0090]-[0092] the characteristics may be utilized to determine if hospitalization is necessary and/or a discharge location after a hospital stay). Here, the present claim does not provide any elements to bound/narrow “treatments”, so the information that assists in the care, notification to medical professionals, and the indications of hospital stay/discharge location are being interpreted to fall under the broadest reasonable interpretation (BRI) of treatment.
Regarding Claims 6, 13, and 20, DeMers in view of Armitage teaches the method/devices of claims 1, 8, and 15, respectively, as stated above. DeMers further teaches the mobile device is positioned in a back pocket of apparel worn by the user (¶[0059]-[0060] the mobile device may be positioned in a pocket in a pair of pants, and may be positioned asymmetrically, which would include front/back pant pockets commonly found on pants; Fig. 2).
Claims 3, 10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over DeMers in view of Armitage as applied to claims 1, 8, and 15 above, respectively, and in view of Bilal (US Patent Application Publication 2022/0028546), hereinafter Bilal.
Regarding Claims 3, 10, and 17, DeMers in view of Armitage teaches the method/devices of claims 1, 8, and 15, respectively, as stated above. The modified DeMers does not specifically teach analyzing the one or more gait parameters using a predictive model to provide a Posture Instability and Gait Disorder score for the user.
Bilal teaches a system, a method, a computer program product, and a computer system for assessing a user’s gait by collecting data while a user walks and applying one or more models to the data (see abstract and Figs. 4-6), in which a gait assessor 134 may be trained on PIGD scores given by a medical professional, as well as gait characteristics, such as gait speed and stride length (see ¶[0032] and ¶[0041]-[0042]; Figs. 4-5), in which the PIGD score may be predicted via the models (i.e., neural network and/or CNN) (see ¶[0041]-[0043]; Figs. 4-6).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the PIGD predictive score generated from a predictive model of Bilal with the gait parameters from the segmented linear portion data of the modified DeMers because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; and/or (2) predictive models (i.e., neural network and/or CNN) are well-known in the art to determine/classify characteristics, such as classifying the gait parameters from the segmented linear portion data of the modified DeMers; and/or (3) the PIGD score would further help a medical professional to provide care for the user; and/or (4) the standard PIGD score is highly subjective and has poor correlation and consistency between different medical professionals (see Bilal ¶[0017]), which would be eliminated by the predictive model approach. It is noted that the present claims do not require any specific metrics to be utilized as inputs into the predictive model for the PIGD score determination; therefore, the PIGD score determined from the gait parameters from the segmented linear portion data of the modified DeMers reads upon the recitation of the present claims.
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over DeMers in view of Armitage as applied to claims 1 and 8 above, respectively, and in view of Bloch et al. (“Introducing a Third Timed Up & Go Test Trial Improves Performances of Hospitalized and Community-Dwelling Older Individuals”, Journal of Geriatric Physical Therapy, Volume 40, Number 3, February 12, 2016), hereinafter Bloch.
Regarding Claims 7 and 14, DeMers in view of Armitage teaches the method/devices of claims 1 and 8, respectively, as stated above. The modified DeMers further teaches the ambulation test comprises a pattern of the user repeatedly walking in a substantially linear path for a distance and then performing a substantially 180º turn (see Armitage ¶[0161]-[0165], the biomarkers, including the walk segment 306c and the turn segment 306d, may be extracted/segmented from the sensor data, in which the segments are identified/extracted from when the subject is performing motions associated with the TUG test, ¶[0123] the sensor data may be collected when the subject performs specialist tests (i.e., a TUG tests) under direction of a clinician or during everyday activities, Fig. 3A). Note that the TUG test involves standing from a chair, walking linearly and turning 180 degrees, then walking back to the chair before sitting down again (see for example “Timed Up and Go Test (TUG)”, Physiopedia, accessed on February 19, 2026, accessed at https://www.physio-pedia.com/Timed_Up_and_Go_Test_(TUG), pg. 2, § Method, the test is performed twice, including the practice trial). Here, the linear walking is repeated, and Armitage indicates that tests (multiple) are performed (see ¶[0123]).
Alternatively and/or additionally, Bloch teaches that a third TUG test is needed to ensure performance stability in certain individuals, with significantly faster times recorded in the third trial (see abstract and § Discussion, ¶1-2).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the user repeat the TUG test as taught in Bloch because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; and/or (2) three or more trials would improve the TUG test results (see Bloch abstract and § Discussion, ¶1-2).
Claims 4, 11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over DeMers in view of Armitage as applied to claims 1, 8, and 15 above, respectively, and in view of Buck et al. (US Patent Application Publication 2017/0147767), hereinafter Buck, and in view of Lee et al. (US Patent Application Publication 2024/0221428), hereinafter Lee.
Regarding Claims 4, 11, and 18, DeMers in view of Armitage teaches the method/devices of claims 1, 8, and 15, respectively, as stated above. DeMers further teaches the one or more gait parameters a turn speed parameter (¶[0056], ¶[0085]-[0086], and ¶[0130] multiple characteristics of the user’s gait may be determined, including a turning rate/speed).
DeMers further teaches the one or more gait parameters include a stride speed parameter and a stride length parameter (¶[0118]-[0121] the characteristics may also include average step speed, and ¶[0130] step length, which may also be determined for a stride).
Alternatively and/or additionally, Buck teaches approaches for monitoring data as a user walking across a smart floor map, involving the comparison of current data to historical data, so as to generate a healthcare insight such as a trend, pattern, or deviation, so a health issue may be predicted or indicated (see abstract and ¶[0042]-[0046]; Fig. 4), in which analysis of the user’s gait (i.e., walking) involves various parameters such as stride length, stride speed, and balance (see ¶[0043]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the gait parameters, including the stride length and stride speed, of Buck with the gait monitoring of the modified DeMers because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; and/or (2) the additional parameters would further help the system and/or a medical professional assess the health of the user (see also Buck ¶[0021]); and/or (3) the modified DeMers requires gait parameters and Buck teaches additional such parameters.
The modified DeMers does not specifically teach that the one or more gait parameters include a steps per turn parameter.
Lee teaches a gait analysis method for calculating gait metrics during a user walking for a preset time (see abstract and Figs. 3-6), in which the subject walks in a straight line, turns, then walks back to the starting position (see ¶[0032]), and the metrics include the direction turning time and the number of strides at the direction turning time (see ¶[0039], ¶[0071], and ¶[0082]). Here, the number of strides at the direction turning time would indicate and necessarily include the turning steps, as a stride is a pair of steps (see for example DeMers ¶[0018]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the gait parameter, including the strides at the direction turning time, of Lee with the gait monitoring of the modified DeMers because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; and/or (2) the additional parameters would further help the system and/or a medical professional assess the health of the user (see Lee ¶[0082]); and/or (3) the modified DeMers requires gait parameters and Lee teaches an additional such parameter.
Claims 5, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over DeMers in view of Armitage as applied to claims 1, 8, and 15 above, respectively, and in view of Barrois et al. (“Observational Study of 180° Turning Strategies Using Inertial Measurement Units and Fall Risk in Poststroke Hemiparetic Patients”, Front, Neurol, 8:194, 15 May 2017), hereinafter Barrois, and in view of Kapur et al. (US Patent Application Publication 2024/0285239), hereinafter Kapur.
Regarding Claims 5, 12, and 19, DeMers in view of Armitage teaches the method/devices of claims 1, 8, and 15, respectively, as stated above. The modified DeMers teaches dividing the gyroscope data into a plurality of subsets of time-series data (see DeMers ¶[0098] and ¶[0138] the mobile device 100 may segment the sensor data into different positions, such as by gait phase; Fig. 7A, such segmentation occurs in the time domain, see for example Fig. 6); and
identifying gait phases, such as the stance and/or impulse phase (see DeMers ¶[0062]-[0079]; Figs. 3 and 5);
wherein each subset of time-series data corresponding to a turn is assigned to the turn portion data, and wherein each remaining subset of time-series data is assigned to the linear portion data (see Armitage ¶[0161]-[0165], the biomarkers, including the walk segment 306c and the turn segment 306d, may be extracted/segmented from the sensor data, in which the segments are identified/extracted from when the subject is performing motions associated with the TUG test, ¶[0123] the sensor data may be collected when the subject performs specialist tests (i.e., a TUG tests) under direction of a clinician or during everyday activities, Fig. 3A).
The modified DeMers teaches to identify and segment the linear portion data and the turn portion data, but not specifically that to identify each turn by comparing a turn angle to a threshold value.
Barrois teaches about analyzing 180° turning strategies using inertial measurement units (IMUs) in poststroke hemiparetic patients (see abstract), in which the IMUs were attached and monitored as the patient walked to a point 10 m away before turning 180° and walking back (see pg. 2-3, § Instrumentation and Data Acquisition), in which the axial rotation of the IMU positioned on the user’s trunk during foot flat phase (i.e., stance/impulse phase) was determined by comparing the integration of the angular velocity of the trunk in the axial plane during each FF phase to an empirical threshold (i.e., 10°), and if it was larger than 10°, it was determined to be during a turn (see pg. 3-4, § 180° Turning Representation).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the trunk angular velocity angle threshold to determine turn of Barrois with the stance/impulse phase and wearable inertial data (i.e., gyro data) of the modified DeMers because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results; and/or (2) the modified Barrois requires a determination of turning and Barrois teaches one such determination; and/or (3) thresholds have a low computation requirement and are easy to implement modality of determining metrics/comparisons.
The modified DeMers does not specifically teach that the subsets/segments are identified by start/stop times.
Kapur teaches segmenting sensor measurements by determining a context window with a beginning and an end (see abstract and Fig. 2), in which the beginning and end of the context window may be identified as time stamps, which can then be used to segment out portions of the sensor data (see ¶[0021], ¶[0045], and ¶[0054]; Fig. 2).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the time stamps to identify the beginning and end modality of Kapur to segment out portions (i.e., turn portions, identified via the threshold angles) of the sensor data of the modified DeMers because (1) it is the application of a known technique to a known method/device ready for improvement to yield predictable results and/or (2) the modified DeMers requires identifying the turn portions and the linear portions of the data and Kapur teaches one such modality of identifying the beginnings and the ends.
Conclusion
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791