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 .
Response to Amendment
The amendments filed 18 August 2025 have been entered. Claims 1 - 20 are pending. Applicant’s amendments have overcome each and every objection to the abstract previously applied in the office action dated 28 April 2025. Applicant’s amendments have overcome each and every objection to the drawings previously applied in the office action dated 28 April 2025. Applicant’s amendments have overcome each and every rejection under 35 U.S.C 112 previously applied in the office action dated 28 April 2025.
Drawings
The drawings were received on 19 August 2025. These drawings are accepted.
Specification
The disclosure is objected to because of the following informalities: reference character “210a” and “210b” has been used to designate both insole (halves) and force sensors (Paragraphs [0046] – [0054], [0057], [0059], [0063] – [0066], [0069] – [0072], [0097], and [0104]), Looking to the submitted drawings, it appears that there is a typographical error such that the force sensors are intended to be “220a – 220e”, as also seen in Applicant’s specification [0046], and the insole pads as 210a and 210, as in Applicant’s Specification at [0050]. Appropriate correction is required.
Claim Objections
Claim 8 is objected because of the following informalities: “are locations on the top insole pad that align with are a first…” likely intended to delete the second “are” with the amendment. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is 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 6 (line 4) and Claim 17 (line 2) recite the limitation "the predetermined profile". There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited “predetermined profile”, as the formerly previously-recited “a predetermined profile” in Claims 1 and 11 for which these claims depend was deleted in the amendment. For the purposes of examination, the term “the predetermined profile” is deemed to claim “a predetermined profile”.
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 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 20, the claim recites an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Step 2A, Prong 1
Claim 20 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, Claim 20 recites an abstract idea.
Specifically, Claim 20 recites (underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 20
A non-transitory computer-readable storage medium including instructions thereon that, when executed by a computer, cause the computer to perform a gait analysis method for determining abnormality in a limb of a subject, the gait analysis method comprising:
detecting places where the limb presses substantially over a stain pad;
generating measurement data from a plurality of force sensors of an insole pad while the insole pad is worn by the limb; and
predicting a ground reaction force based on the generated measurement data.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Claim 20, these limitations include:
observation and judgment to perform a gait analysis method for determining abnormality in a limb of a subject
observation and judgment of places where the limb presses substantially over a stain pad
observation and judgment of measurement data from the plurality of force sensors while the insole pad is worn by the limb
observation and judgment to predict a ground reaction force based on observation and judgment of the generated measurement data
all of which are grouped as mental processes under the 2019 PEG.
As claimed, the aforementioned limitations are mental processes that would be performed by a biomedical, medical, or engineering professional using their education, background, and experience, and a pen and paper.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in Independent Claim 20 are not integrated into a practical application under 2019 PEG because the additional elements (identified above), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, within the Claim 20, the additional elements of:
a non-transitory computer medium
computer
Additional elements recited in Claim 20 include a “non-transitory computer medium” to include instructions and a “computer” to “execute” and “perform”.
These components are recited at a high level of generality. These generic hardware component limitations “non-transitory computer medium” and “computer” are no more than mere instructions to apply the exception using generic computer components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Claim 20 include pre-solution activity limitations, such as:
A non-transitory computer-readable storage medium including instructions thereon that, when executed by a computer
the gait analysis method comprising:
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “non-transitory computer medium” and “computer” as recited in Claim 20 are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in independent Claim 20 are not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed system and method merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract ideas identified above in in Claim 20 are not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claim 20 is directed to an abstract idea under 2019 PEG.
Step 2B –
Claims 20 does not include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
This claim requires the additional elements of: “non-transitory computer medium” and “computer”.
The additional elements of the “non-transitory computer medium” and “computer” in Claims 20, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, the “non-transitory computer medium” is described generically in [0111] as “any non-transitory computer- readable storage media for storing data and/or software” including “one or more solid-state storage devices such as flash memory chips”, “one or more mass storage devices”, or ” non-transitory, volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information”. It is shown as a generic box element “memory 920” in Fig 13.
Per applicant’s specification, the “computer” is described generically in [0111] as a sum of its generic computing parts with “ computing device 900 may include a processor 910, a memory 920, a display 930, a network interface 940, an input device 950, and/or an output module 960”. It is shown as a generic box element “computing device” 900 in Fig 13.
There is nothing particular to the structures of each “non-transitory computer medium” and “computer” that deems it more than well-understood, routine, or conventional.
Accordingly, in light of Applicant’s specification, the claimed terms “non-transitory computer medium” and “computer” are reasonably construed as a generic computing devices or hardware. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “non-transitory computer medium” and “computer”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claim 20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus of Claim 20 is directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. Claim 20 does not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that this claim amounts to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Claim 20 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claim 20 merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, Claim 20 does not amounts to significantly more than the abstract idea itself. Accordingly, Claim 20 is not patent eligible and is rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hsu, et. al., “The Design and Application of Simplified Insole-Based Prototypes with Plantar Pressure Measurement for Fast Screening of Flat-Foot”, hereinafter Hsu, in view of Merrell et. al., (United States Patent Application Publication US 2016/0192862 A1), hereinafter Merrell.
Regarding Claim 20, Hsu discloses A non-transitory computer-readable storage medium for determining abnormality in a limb of a subject ([Page 4, “2.2.2. Self-Made Simplified Instrument”, Paragraph 1] - [Page 4, “2.2.3. Hardware System Design”, Paragraph 1] including “…a PC with the Python environment via Bluetooth connection”; [Abstract]; Fig 2)(Examiner notes that the instructions and software necessary to perform the data analysis to complete a gait analysis method would be on the personal computer, “Python and Matlab environment” of Figure 2.),), the gait analysis method comprising:
detecting places when the limb presses substantially over a stain pad ([Page 3 - 4, All of “2.2.1. Ink-Type Footprint Printer” Section, Paragraphs 1 - 2] including “…the subjects’ footprints were obtained on the paper by the ink”, Figure 1 with footprint and stain pad”; Figure 6)(Examiner notes that all of the places that a subject’s foot pressed over the ink stain pad are shown in black in Figure 6 which shows where the ink was deposited on the paper place by the pressing foot anatomy.);
generating measurement data from a plurality of force sensors of an insole pad ([Page 7, “2.3 Data Analysis”, Paragraph 1] “force data” from the first to fifth sensors”; [Page 7, “2.2.7. “Dynamic Insole-Type Plantar Pressure Measurement”, Paragraph 1”] “…self-made insole-type planar pressure device”) while the insole pad is worn by the limb ([Page 7, “2.2.7. “Dynamic Insole-Type Plantar Pressure Measurement”, Paragraph 1”] “The subjects were asked to walk in a dynamic trial while wearing the self-made insole-type plantar pressure device.”; [Page 7, “2.3 Data Analysis”, Paragraphs 1 - 2”] including “…three successful gait trials were collected”); and
Hsu does not disclose predicting a ground reaction force based on the generated measurement data.
Specifically for Claim 20, Merrell teaches predicting a ground reaction force based on the generated measurement data ([0059] “predict a particular stance…convert the shoe sensor data to…GRF…Once the estimated parameter vector….is obtained for the particular stance, the associated predicted GRF (or acceleration or pressure) curve can be obtained…”; Fig 10A-C; [0058] “converting the voltage data to ground reaction force data…”; [0057]; Fig 7)
Hsu and Merrell both disclose and teach measurements of sections of the foot using multiple force sensors at positions underneath the foot in an insole: Hsu with force data from force sensitive resistance sensors at different positions in an insole pad underneath the foot, and Merrell with multiple sensors (Merrell: Figs 2A and 2B) sensing force underneath a foot in a shoe insole [Merrell [0024]) Merrell provides a motivation to combine at [0010] with “implementations can provide real-time feedback for correcting gait, weight transfer, etc., so that the person wearing the shoe is made aware of such errors.” and “shoe-based analysis system may include one or more profiles of ideal or desired activity patterns and the voltage data provided by the self-sensing composite polymeric foam can be compared against an activity profile.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using data from sensors underneath a foot to predict GRF would be useful for determining if a person’s gait is aligned with “ideal” patterns or a potentially injurious pattern. It would have been predictable to use the prediction model for ground reaction force with any similar gait analysis system with sensors located underneath a foot within a shoe, as it would continue to operate with the function of analyzing force-related gait data with a prediction model.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the insole sensors providing force data for analysis disclosed by Hsu with the prediction model to predict ground reaction force using force data input from insole sensors taught by Merrell, creating a single gait sensor insole system for predicting GRF from the sensor data.
Claims 1, 3 – 5, 7, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Malawey, et. al., (US Patent Application Publication US 2018/0333078 A1), hereinafter Malawey, in view of Elangovan, et. al., (WO 2016/092313 A1), hereinafter Elangovan, further in view of Merrell.
Regarding Claim 1, Malawey discloses A gait analysis apparatus ([0068] “real-time passive foot sensor insole feedback device 12”; [0067] “The feedback device of the present invention determines when a person has placed enough weight upon his/her foot in order to safely take the next step”) comprising:
a bottom insole pad (Fig 7, “lower layer” 204 of “insole” 206);
a top insole pad (Fig 7, “upper layer” 202 of “insole” 206) layered over the bottom insole pad (Fig 7, “upper layer” 202 shown layered over the “lower layer” 204) and configured to be worn by a limb of a subject ([0030] “an insole adjacent to the person's foot. The foot and the insole are in a shoe.”)(Examiner notes that the insole is worn by the person’s foot by being adjacent to the person’s foot while the shoe is worn.);
a plurality of force sensors (Fig 7, five of “sensor” 210 shown) configured to sense force exerted by the limb ([0032] “The sensors are piezoresistive variable resistors, which act as force sensors when the person applies force to the insole.”) and affixed between the top insole pad and the bottom insole pad (Fig 7, the line of “sensor” 210 and “wire” 216 associated with the sensors; [0137] – [0138] including “The sensor in the recess will be flush with the upper surface 212 of the lower layer and the lower surface 214 of the upper layer”)(Examiner notes that this securely placing (affixed) the sensors in pockets between the two insole pads.); and
a processor (Fig 2, “microprocessor” 34) configured to cause the gait analysis apparatus to: collect measurement data ([0037] “force data signal”) from the plurality of force sensors ([0037] “Each sensor of the multiple sensors sends a force data signal to the microprocessor.”; [0137]) and
Malawey does not disclose at least in two directions and predict a ground reaction force based on the collected measurement data.
Regarding Claim 1, Elangovan teaches a plurality of force sensors (Fig 14, [Page 30, Lines 33 – 34] “miniature force plate 402 (MFP) (fourteen n this implementation)” configured to sense force exerted by the limb at least in two directions ([Page 33, Lines 30 – 32] “ Figures 45 to 51 illustrate a smart insole (or in-shoe system) to perform as a multiple force plates system to measure the forces (and their directions) acting between the foot and the insole in the x, y and z axis directions (Fx, Fy, Fz).”) ([Page 33, Line 34] – [Page 34, Lines 1 – 2] “The MFPs are adapted to act autonomously, measuring and recording local Fx, Fy, and Fz, as well as parts of a "sensor network" with the other MFPs.”)
Elangovan teaches a prior art comparable device that is used to sense human gait forces using a layered, instrumented shoe insole device. It has a layer of “miniature force plate 402 (MFP)” force sensors placed between two layers of insole material “to measure the forces (and their directions) acting between the foot and the insole in the x, y and z-axis directions”. This is the same function as Malawey’s layered, instrumented shoe insole device that senses human gait forces. For sensing forces, Elangovan teaches motivation to substitute a set of force sensors for obtaining an accurate measurement of force at [Page 1, Lines 15 – 17] with “the accurate measurement of foot-ground pressure data gives important information about a person's foot condition and gait and can be used to improve recovery, performance or to design orthotics footwear.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that incorporating force sensors with tri-axis force sensing capability would yield more accurate measurements of foot-associated forces than a single-axis force sensor, with more accurate data enabling better gait models for more effective recovery, performance, or orthotics plans.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the with the uni-axial “sensors” 210 Malawey in the layered insole with the tri-axial “miniature force plates 402 (MFP)” of Elangovan. Structurally, the insole disclosed in Malawey is a layered pad structure with the “sensors” 210 nested between the layers, aligned with particular anatomic locations on the foot. The insole taught by Elangovan is also a layered pad structure with the “miniature force plates 402 (MFP)” nested between the layers, aligned with particular anatomic locations on the foot (Elangovan: Fig 47). Malawey discloses the “sensors” 210 to use for measuring gait-related foot force, which is the same function of the “miniature force plates 402 (MFP)” in Elangovan. Therefore it would yield a predictable result to substitute Elangovan’s set of “miniature force plates 402 (MFP)” for the force “sensors” 210 of Malawey. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Elangovan does not teach predict a ground reaction force based on the collected measurement data.
Merrell teaches predict a ground reaction force based on the collected measurement data ([0059] “predict a particular stance…convert the shoe sensor data to…GRF…Once the estimated parameter vector….is obtained for the particular stance, the associated predicted GRF (or acceleration or pressure) curve can be obtained…”; Fig 10A-C; [0058] “converting the voltage data to ground reaction force data…”; [0057]; Fig 7).
Malawey and Merrell both disclose and teach measurements of sections of the foot using multiple force sensors at positions underneath the foot in an insole: Malawey with force data from force sensors at different positions in a layers insole pad underneath the foot, and Merrell with multiple sensors (Merrell: Figs 2A and 2B) sensing force underneath a foot in a shoe insole [Merrell [0024]) Merrell provides a motivation to combine at [0010] with “implementations can provide real-time feedback for correcting gait, weight transfer, etc., so that the person wearing the shoe is made aware of such errors.” and “shoe-based analysis system may include one or more profiles of ideal or desired activity patterns and the voltage data provided by the self-sensing composite polymeric foam can be compared against an activity profile.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using data from sensors underneath a foot to predict GRF would be useful for determining if a person’s gait is aligned with “ideal” patterns or a potentially injurious pattern. It would have been predictable to use the prediction model for ground reaction force with any similar gait analysis system with sensors located underneath a foot within a shoe, as it would continue to operate with the function of analyzing force-related gait data with a prediction model.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the insole sensors providing force data for analysis disclosed by Malawey with the prediction model to predict ground reaction force using force data input from insole sensors taught by Merrell, creating a single gait sensor insole system for predicting GRF from the sensor data.
Regarding Claim 3, Malawey in view of Elangovan, further in view of Merrell discloses, as described above, The gait analysis apparatus according to claim 1. For the remainder of Claim 3, Malawey discloses wherein each force sensor (Fig 7, “sensor” 210) is a piezo-resistive force sensor ([0032] “The sensors are piezoresistive variable resistors, which act as force sensors when the person applies force to the insole.”).
Regarding Claim 4, Malawey in view of Elangovan, further in view of Merrell discloses, as described above, The gait analysis apparatus according to claim 1. For the remainder of Claim 4, Malawey does not disclose wherein the at least two directions include a first direction along a superior-inferior axis and a second direction along an anterior-posterior axis of the subject.
Elangovan teaches wherein the at least two directions ([Page 33, Line 34] – [Page 34, Lines 1 – 2] “The MFPs are adapted to act autonomously, measuring and recording local Fx, Fy, and Fz, as well as parts of a "sensor network" with the other MFPs.”)(Examiner notes that MFP stands for “miniature force plate” [Page 33, Line 33]) include a first direction along a superior-inferior axis ([Page 34, Line 1] “measuring and recording local…Fz”) and a second direction along an anterior-posterior axis ([Page 34, Line 1] “measuring and recording local…Fy”) of the subject.
As explained in greater detail in Claim 1, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the uni-axial “sensors” 210 Malawey in the layered insole with the tri-axial “miniature force plates 402 (MFP)” of Elangovan due to their compatible insole structures and matching functions. Therefore it would yield a predictable result to substitute Elangovan’s set of “miniature force plates 402 (MFP)” for the force “sensors” 210 of Malawey to create a gait sensing device with the capability to measure a more accurate force output, in a superior-inferior direction and anterior-posterior direction, as recited in Claim 4. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Regarding Claim 5, Malawey in view of Elangovan, further in view of Merrell, discloses as described above, The gait analysis apparatus according to claim 4. For the remainder of Claim 4, Malawey does not disclose wherein each force sensor is further configured to sense force in a direction along a medial-lateral axis, which is perpendicular to the superior-inferior axis
Elangovan teaches wherein each force sensor (Fig 1, “magnetic field generator 12 and magnetic field sensor 14”) is further configured to sense force in a direction along a medial-lateral axis, which is perpendicular ([Page 34, Line 1] “measuring and recording local…Fx”) to the superior-inferior axis ([Page 34, Line 1] “measuring and recording local…Fz”)
As explained in greater detail in Claim 1, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the uni-axial “sensors” 210 Malawey in the layered insole with the tri-axial “miniature force plates 402 (MFP)” of Elangovan due to their compatible insole structures and matching functions. Therefore it would yield a predictable result to substitute Elangovan’s set of “miniature force plates 402 (MFP)” for the force “sensors” 210 of Malawey to create a gait sensing device with the capability to measure a more accurate force output, in a direction perpendicular to the superior-inferior direction and to the anterior-posterior direction, as recited in Claim 5. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Regarding Claim 7, Malawey in view of Elangovan, further in view of Merrell discloses, as described above, The gait analysis apparatus according to claim 1. For the remainder of Claim 7, Malawey discloses wherein the plurality of force sensors (Fig 7, five of “sensor” 210 shown) are affixed at places where the limb presses over the top insole pad ([0088] “The five force sensors in the insole will be positioned under specified areas of the foot: the heel, the outside arch, the fifth metatarsal head, the first metatarsal head, and the hallux (big toe).”.
Regarding Claim 8, Malawey in view of Elangovan, further in view of Merrell discloses, as described above, The gait analysis apparatus according to claim 7. For the remainder of Claim 8, Malawey discloses wherein the places [0088] “The five force sensors in the insole will be positioned under specified areas of the foot:…”) are locations on the top insole pad that align with a first distal phalanx ([0088] “…and the hallux (big toe).”)(Examiner notes that the first distal phalanx is in the “big toe”), metatarsal joints ([0088] “the fifth metatarsal head, the first metatarsal head”), and calcaneus of the limb ([0088] “the heel…”)
Regarding Claim 10, Malawey in view of Elangovan, further in view of Merrell discloses, as described above, The gait analysis apparatus according to claim 1. For the remainder of Claim 10, Malawey discloses further comprising:
an amplifier ([0112] “Op-Amp”)(Examiner notes that “Op-Amp” stands for operational amplifier) configured to amplify analog signals from the plurality of force sensors ([0112] “One end of each force sensor will be connected to the common pin, which is connected to an Op-Amp internal to the microprocessor.”)(Examiner notes that when an op amp is used in a circuit, it is to amplify signals),
wherein the amplified analog signals are digitized to generate the measurement data ([0112] “The output terminal of the Op-Amp is connected to the input terminal of the ADC internal to the microprocessor.”)(Examiner notes that an “ADC” is an analog-to-digital converter that converts the analog measurement data signals to digital signals).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Malawey in view of Elangovan, further in view of Merrell, and in further in view of Cherneski, (US Patent Application 2018/0184759 A1), hereinafter Cherneski.
Regarding Claim 2, Malawey in view of Elangovan, further in view of Merrell discloses as described above, The gait analysis apparatus according to claim 1.
For the remainder of Claim 2, Malawey does not disclose and Elangovan does not teach wherein a top surface of the top insole pad is made of a non-slippery material. Malawey is open to having a top insole pad surface made of a non-slippery material when it broadly discloses [0085] “The upper layer and the lower layer will be a flexible insole-shaped plastic or a flexible insole-shaped polymer.” There are non-slippery materials within the scope of broadly-disclosed “polymers”. Additionally, Malawey discloses at [0096] that “The insole with the sensors can be removed and used for several patients by a therapist or be removed and used by a person for multiple shoes.” Therefore, there is motivation to combine with other removable, flexible polymer insoles.
Cherneski teaches a non-slip removable footwear insert. Regarding Claim 2, Cherneski teaches wherein a top surface (Fig 1a [0059] “upper surface 101a”) of the top insole pad ([0059] “…of the insert member 101”) is made of a non-slippery material (Fig 1a, “non-slip material 102” [0059]); .
Malawey teaches a prior art shoe insole device upon which the claimed invention (a top, non-slip surface of the insole pad) can be seen as an “improvement” (Malawey only discloses a flexible, shoe insole device without a specifically-described non-stick surface.)
Cherneski teaches a prior art comparable device (shoe insole) that has a layer of non-stick surface on it to provide gripping contact between the shoe wearer’s foot and the top surface of the insole. Malawey teaches motivation to combine with a non-slip surface on the insole at [0096] “The purpose of the insole is to safely house the multiple force sensors while maintaining the comfort and safety of the person.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that incorporating a non-slip surface on the top of the insole would reduce the wearer’s foot movement within the shoe that could cause skin irritation, thereby furthering the goal of “maintaining the comfort and safety of the person”. Cherneski also teaches motivation to combine with a non-slip surface with ([0003] “there is a need for a shoe insert that provides grip between the material of the shoe insert and the surface of the user's foot in contact with the shoe insert during use to prevent slippage between the shoe insert and the surface of the user's foot in contact with the shoe insert.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that incorporating a non-slip surface on the top side of the insole toward the wearer’s foot would reduce slippage between the foot and the insole for a more comfortable shoe.
Thus, the manner of enhancing a particular device (a shoe insole) was made part of the ordinary capabilities of one skilled in the art based upon the teaching improvement in Cherneski. Accordingly, one of ordinary skill in the art would have been capable of applying this known “improvement” technique in the same manner to the prior art gait sensing insole device of Malawey, and the results would have been predictable to one of ordinary skill in the art. As disclosed in Malawey, the upper layer is a “flexible insole-shaped plastic or a flexible insole-shaped polymer”. Cherneski teaches compatible material considerations as well, at [0060] “The non-slip material 102 can also be made, for example, from natural rubber, synthetic rubber, natural latex, thermoplastic rubber (TPR), thermoplastic elastomers (TPE), polyurethane, polyvinyl chloride, materials with synthetic suede-like non-slip finishes, materials with natural suede-like non-slip finishes, etc.) and [0058] “The insert member 101 is made of, for example, polyurethane, Nylon, neoprene, and other synthetic plastics or thermo plastic elastomers that provide comfort to a user.” One skilled in the art would have readily recognized that the flexible plastic or polymer insoles (Malawey’s “insole” 206 and Cherneski’s “insert member 101”) could be upgraded with a non-stick foot-facing surface like Cherneski’s “non-slip material 102” for reliable, comfortable placement on a user’s foot.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the shoe “insole” 206 disclosed in Malawey and the “insert member 101” with the “non-slip material 102” on its foot-facing top surface taught by Cherneski, creating a single apparatus wearable on a user’s foot with less slip and greater comfort. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Malawey in view Elangovan, further in view of Merrell, and further in view of Howell et. al., “Kinetic Gait Analysis Using a Low-Cost Insole”, hereinafter Howell.
Regarding Claim 6, Malawey in view of Elangovan, further in view of Merrell discloses, as described above, The gait analysis apparatus according to claim 1.
For the remainder of Claim 6, Malawey does not disclose and Elangovan does not teach wherein a deep learning algorithm compares previous measurement data, which has been collected synchronously by the plurality of force sensors and a force plate, and generates the predetermined profile.
Regarding Claim 6, Howell teaches wherein a deep learning algorithm ([Page 3286, “Section D. Analysis”, Paragraph 2] “A least-squares linear regression was used…”) compares previous measurement data ([Page 3286, “Section D. Analysis”, Paragraph 1] “Data from the MAL and the insole”)(Examiner notes that Howell teaches “MAL” as “Motion Analysis Lab” [Page 3285, “Section B. Study Procedure”, Paragraph 1]. The MAL data includes all of the data collected using the equipment in the procedure prior to the algorithm analysis.) , which has been collected synchronously by the plurality of force sensors (([Page 3286, “Section D. Analysis”, All of Paragraph 1] “insole” and “insole data”; [Page 3286, “Section A: Hardware”, Paragraph 1] “An insole with 12 sensors was designed to fit into the subject’s own shoes, as shown in Fig. 1. The sensors were FSRs, model 402 (Interlink Electronics, Camarillo, CA)”)(Examiner notes that FSR is “force sensitive resistor” [Page 3284, “Section I: Introduction”, Paragraph 3]), and a force plate ([Page 3286, “Section D. Analysis”, All of Paragraph 1] “…with simultaneous collection from the insole and the motion analysis equipment”, “The motion analysis equipment includes…two OR6 series multi-axis force plates (Advanced Mechanical Technology, Inc., Watertown, MA).”), and generates the predetermined profile ([Abstract] “Subject-specific linear regression models”; [Page 3286, “Section D. Analysis”, Paragraph 2] “A least-squares linear regression was used to weight the sensor forces to match the motion lab data for normalized GRF and moments”)(Examiner notes that “GRF” is ground reaction force.)
Howell teaches a data analysis method using machine learning that compares in-shoe force sensor data to a baseline “MAL (motion analysis lab)” data to determine foot loading, or “GRF (ground reaction force)”. This is the same function as Malawey’s “data analysis” and generally-described “baseline” data against which in-shoe force sensor measurement data is compared to determine foot loading. Both in-shoe sensor systems are used in the field of stroke patient rehabilitation through gait-related therapy. Additionally, Howell teaches motivation to combine to have a deep learning model for in-shoe measurements at [Page 3284, “I. Introduction Section”, Paragraph 4] “Realizing GRF and other kinetic measures outside of a motion analysis lab may require machine learning techniques to capitalize on the numerous small, local measurements inherent to in-shoe measurement.” Therefore, a person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that using machine learning algorithms would be useful for obtaining more accurate in-shoe data for comparison and analysis, leading to better information to guide therapy exercises for stroke patients.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the “data analysis” and generally-described “baseline” data of Malawey with the “Subject-specific linear regression models” of Howell. Malawey discloses data analysis of in-shoe force sensors relative to a “baseline” data profile to determine foot loading, which is the same function of Howell’s linear regression analysis relative to MAL data models to determine ground reaction forces (loading) with the foot. Therefore it would yield a predictable result to substitute Howell’s “Subject-specific linear regression models” with MAL data for ground reaction forces for the “data analysis” and generally-described “baseline” data of Malawey. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Malawey in view Elangovan, further in view of Merrell, and further in view of Hsu et. al., “The Design and Application of Simplified Insole-Based Prototypes with Plantar Pressure Measurement for Fast Screening of Flat-Foot”, hereinafter Hsu.
Regarding Claim 9, Malawey in view of Elangovan, further in view of Merrell discloses, The gait analysis apparatus according to claim 1. For the remainder of Claim 9, Malawey does not disclose and Elangovan does not teach wherein the measurement data is normalized based on a weight of the subject and a time span of a quiet standing phase with no or minimal movements. Malawey is open to combining with a method to normalize the sensors using quiet standing by broadly describing the process to obtain a “baseline” at [All of 0047] “To calibrate the feedback device, a physical therapist will position the person on the insole in a manner deemed to be the baseline…the force sensors will take readings from each individual sensor over a five second period. The data will be averaged for each sensor.” It is not specified that this “position” in Malawey is specifically quiet standing.
Hsu teaches wherein the measurement data is normalized ([Page 7, “2.3 Data Analysis” Section, Paragraph 1]”…average normalized force of each sensor”) based on a weight of the subject ([Page 7, “2.3 Data Analysis” Section, Paragraph 1] “In terms of static standing, the average of the force of static standing for five seconds was divided by