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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/7/2025 has been entered.
Status of claims
Claims 1, 14, 30, and 43 are amended.
Claims 2-13, 15-29 and 41-42 are cancelled.
Response to Arguments
Applicant's arguments filed, see pages 6-8, filed 10/7/2025, have been fully considered but
they are not persuasive.
35 U.S.C. 101: Step 2A Prong One
Regarding claim 1, applicant argues that the claim does not recite a mental process because the
claim recites additional elements to perform the operation in real-time. The examiner respectfully disagrees and argues that the step, “determine that the wearer is walking, comprising detecting a first event, detecting a second event and detecting a repeat of the first event, wherein the first event is a heel strike event,” is a diagnosis step that a physician may determine through observation of heel and knee movements of the patient. Detecting a heel strike for a patient may be observed during real-time. The processor is recited generically and is interpreted as computer implementation to perform the abstract idea. The two portion knee brace, “wherein at least one sensor mounted to the first brace portion and/or the second brace portion, wherein the at least one sensor comprises an inertial measurement unit (IMU),” are additional elements. However, these additional elements are recited as pre-solution activity to the step of data gathering.
35 U.S.C. 101: Step 2A Prong Two
The applicant argues that the step, “process of determining walking activity via a processor,” is
concrete application in the biomechanical field of health monitoring. Therefore, the applicant argues that the claim integrates the abstract idea into a practical application. The examiner respectfully disagrees and argues that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the additional elements of claims 1 and 14 are merely generically recited computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity.
35 U.S.C. 101: Step 2B
The applicant argues that the additional elements are not well-understood and conventional in
the art. The examiner respectfully disagrees and argues that the knee brace portions and IMUs are well-known as disclosed in US 20190038225 A1 (fig. 9A; paragraph 25). A first inertial sensor and a second inertial sensor of wearable harness for use as a wearable joint rehabilitation device positioned at respective first and second body portions relative to a patient's body joint. The examiner additionally argues that the processor is recited generically and amount to no more than mere computer implementation to perform the abstract idea of detecting heel strikes and walking patterns.
Applicant’s arguments, see pages 9-10, filed 10/7/2025, with respect to the rejection(s) of
claim(s) 1-7, 9, 12, 14-18, 20-22, and 25-27 under 35 U.S.C. 103 rejection have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
35 U.S.C. 103:
Regarding claim 1, applicant has amended the claim to incorporate limitations from claim 29
that had no prior art rejection from the previous office action. Specifically, “determine that the wearer is walking, comprising detecting a first event, detecting a second event and detecting a repeat of the first event, and wherein the first event is a heel strike event detected by the processor based on the accelerometer data.” Therefore, the 35 U.S.C. 103 rejection has been withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 14, 30-40, and 43-45 are rejected under 35 U.S.C. 101 because the claimed
invention is directed to an abstract idea without significantly more. Claims 1 and 14 recite a brace and system with instructions for performing operations of the device comprising:
detect a motion parameter of the wearer;
generate input data indicative of the motion parameter;
and process the input data to determine the wearer is walking comprising detecting a first event, detecting a second event and detecting a repeat of the first event, and wherein the first event is a heel strike event;
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is
evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to a device and claim 14 is directed towards a system and thus meet the
requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Claims 1 and 14 recite a brace and system with instructions for performing operations of the
device comprising:
detect a motion parameter of the wearer;
generate input data indicative of the motion parameter;
and process the input data to determine the wearer is walking comprising detecting a first event, detecting a second event and detecting a repeat of the first event, and wherein the first event is a heel strike event;
If a claim limitation, under its broadest reasonable interpretation, covers performance of the
limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1 and 14 recite an abstract idea of a mental process.
Claims 1 and 14 recite the abstract idea of a mental process. The limitations as drafted in the
claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic processing system and memory, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example:
“Detect a motion parameter of the wearer.” A physician may observe and indicate a motion parameter of the user or patient.
“Generate input data indicative of the motion parameter.” Based on the motion parameter, the physician may write down data on a piece of paper.
“Process the input data to determine the wearer is walking comprising detecting a first event, detecting a second event and detecting a repeat of the first event, and wherein the first event is a heel strike event.” A physician may make a diagnosis based on the received data. This diagnosis may be an observation of heel strikes or walking patterns.
Furthermore claims 27, 32, and 38 recite additional steps that can be manually performed by
the clinician.
“determine that the wearer is walking by detecting a first event, detecting a second event and detecting a repeat of the first event.” A physician can simply observe different motion events of a patient.
“measure a maximum knee angle and a minimum knee angle.” A maximum and minimum angle is a simple calculation to be performed in the human mind.
“detect a first event; detect a second event; detect a repeat of the first event; distance travelled; calculate walking velocity; determine functional range-of-motion; and collect and/or aggregate data over multiple cycles.” A physician may determine multiple events of the patient to give a diagnosis on the patients range of motion and what activity the patient is doing.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial
exception into a practical application?
Claims 1 and 14 recite the additional elements of a “superior and inferior knee brace portions”,
“IMU and accelerometer sensors”, and “a processor” which are being interpreted as a processor of a wearable data gathering device. However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical
application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the
judicial exception?
The additional elements when considered individually and in combination are not enough to
qualify as significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, “superior and inferior knee brace portions”, “IMU and accelerometer sensors”, and “a processor” which are being interpreted as a processor of a wearable data gathering device as recited to perform the steps of:
detect a motion parameter of the wearer;
generate input data indicative of the motion parameter;
and process the input data to determine the wearer is walking comprising detecting a first event, detecting a second event and detecting a repeat of the first event, and wherein the first event is a heel strike event;
amount to no more than mere instructions to apply the exception using generic computer
components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Leavitt et al (U.S. Patent Application Publication Number: US 2019/0038225 A1, hereinafter “Leavitt”) and Davidson et al. US Pub.: US 2017/0000389, hereinafter “Davidson” teaches a wearable device that comprises sensors and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
Although there is no prior art rejection for claims, the claims cannot be considered allowable subject matter due to the 35 U.S.C. 101 rejection disclosed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN (email: Thien.Tran1@uspto.gov) whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792