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 . 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 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.
Response to Amendment
This Office Action is responsive to the amendment filed 11/11/2025 (“Amendment”). Claims 17, 18, 21, 27, 28, and 33-35 are currently under consideration. The Office acknowledges the amendments to claims 17, 18, 21, 27, and 28, as well as the cancellation of claims 19, 20, 22-26, and 29 and the addition of new claims 33-37. Claims 1, 8-10, and 30-32 remain withdrawn. New claims 36 and 37 are additionally withdrawn as explained below.
Claims 36 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/11/2025. However, because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Newly submitted claims 36 and 37 are directed to an invention that is independent or distinct from the invention originally claimed (and elected) for the following reasons: they correspond to a method of providing real-time joint range of motion data, which is like the withdrawn claim 30, and they lack unity of invention with the other groups because even though the inventions require certain technical features, these features are not special technical features as they do not make a contribution over the prior art in view of Inan and Slycke as already outlined in the Non-Final Rejection of 08/11/2025 and as shown with respect to claim 17 below.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Claim Objections
Claim 17 is objected to because of the following informalities: the recitation of “characterised in that” should be removed/replaced since it is consistent with European patent practice, not US patent practice.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claims 17, 18, 21, 27, 28, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2018/0289313 (“Inan”) in view of US Patent Application Publication 2009/0278791 (“Slycke”).
Regarding claim 17, Inan teaches [a] patient rehabilitation system (¶ 0101) to provide real-time joint motion data (Fig. 5, joint angle) to assess the capability of a joint, the system comprises a wearable sensor (Figs. 2A, 2B) for providing real-time joint range of motion data (¶ 0157), …, the sensor continuously reports its orientation about its own internal tri-axial frame, and the sensor comprises firmware to interpret raw signals from these constituent components in order to derive angular orientation data for the sensor about each of three mutually orthogonal axes (¶ 0156, sensor placement and orientation are arbitrary, but can still be used to report on joint angle), … .
Inan does not appear to explicitly teach the sensor being stand-alone whereby only one sensor is needed to measure multiplanar movement at a single joint. Inan does not appear to explicitly teach that orientation data is determined relative to an arbitrary cartesian coordinate frame of reference so that at any time the orientation of the sensor may be defined as lying parallel to any particular axis of the frame of reference, and thereby having an angular offset of zero, such that all subsequent measurements of orientation are defined relative to that reference orientation, whereby the sensor can be fitted to a limb in any orientation and the wearer can be instructed to adopt any reference posture for that limb, and the sensor may then be zeroed to that postural position, such that all subsequent measurements are defined relative to that reference postural position for the limb (although ¶ 0156 does describe the configuration working despite arbitrary sensor placement and orientation).
Slycke teaches a similar sensor system that uses only one sensor (Fig. 1C, sensor cluster 9, comprising an inertial module 3 and a magnetic module 2) to determine orientation in space using e.g. the earth’s magnetic field (¶ 0026). A magnetic transmitter 7 (Fig. 1C, ¶ 0022 – also see Fig. 2 and related description) can also be used to enable ambulatory measurement with respect to any coordinate system (Slycke: ¶¶s 0005, 0006) by calibrating and recalibrating measured values every time magnetic field transmitters 7 are activated (¶ 0039).It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the single sensor and the magnetic module of Slycke in Inan instead of e.g. two IMUs, as the simple substitution of one sensor arrangement for another with predictable results (still being able to obtain the joint angle data desired in Inan), and for the purpose of ambulatory measurement with respect to any coordinate system (Slycke: ¶¶s 0005, 0006). Thus, orientation data is determined relative to an arbitrary coordinate frame with an offset of zero based on a change in reference frame (Slycke: ¶ 0039, recalibrating).
Regarding claim 18, Inan-Slycke teaches all the features with respect to claim 17, as outlined above. Inan-Slycke further teaches in which the sensor is provided in a removable strap or brace (Slycke: ¶ 0025, a strap, as the simple substitution of one attachment arrangement for another, with predictable results (securing the sensor with respect to a joint)).
Regarding claim 21, Inan-Slycke teaches all the features with respect to claim 17, as outlined above. Inan-Slycke further teaches configured for measurement of single plane motion including flexion and extension, and abduction/adduction movements and rotation movements (Inan: ¶ 0337, flexion, extension, rotation, abduction, and indeed any 3D movement since the sensor comprises 3D accelerometers, gyroscopes, and magnetometers (Inan: ¶ 0150; Slycke: ¶ 0005)).
Regarding claim 27, Inan-Slycke teaches all the features with respect to claim 17, as outlined above. Inan-Slycke further teaches being remotely monitorable by a clinician (Inan: ¶ 0297).
Regarding claim 28, Inan-Slycke teaches all the features with respect to claim 27, as outlined above. Inan-Slycke further teaches comprising an alarm process if there are any qualitative or qualitative deviations in terms of patient compliance and progress (Inan: ¶¶s 0033, 0034).
Regarding claim 33, Inan-Slycke teaches all the features with respect to claim 17, as outlined above. Inan-Slycke further teaches the system comprises associated software, in which data is collected and transmitted from the sensor in real time and a visual demonstration of range of movement achieved is provided, and in which precise locational data provided by the sensor together with the associated software allows for an exact replication of joint movement to be shown to the patient to ensure compliance with a rehabilitation schedule (Inan: Fig. 4A)
Regarding claim 35, Inan-Slycke teaches all the features with respect to claim 33, as outlined above. Inan-Slycke further teaches in which the sensor is connectable to an application on a mobile phone or tablet (Inan: ¶ 0297, for remote processing and providing an indication) to provide the visual demonstration of range of movement achieved (Inan: Fig. 4A, etc.).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Inan-Slycke in view of US Patent 11,684,260 (“Wiedenhoefer”).
Regarding claim 34, Inan-Slycke teaches all the features with respect to claim 33, as outlined above. Inan-Slycke does not appear to explicitly teach in which instructions can be sent and/or updated in real time by a physician or healthcare professional.
Wiedenhoefer teaches a clinician being able to change settings for a patient, the settings including e.g. which exercise to perform (Fig. 15 and related description).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enable a clinician to send patient exercise instructions in the combination as in Wiedenhoefer, for the purpose of being able to guide a user and respond to their changing physical condition (Wiedenhoefer: Fig. 15 and related description).
Response to Arguments
Applicant’s arguments filed 11/11/2025 have been fully considered.
In response to the arguments regarding the rejections under 35 USC 103, they are not persuasive. Slycke uses only one sensor at a single joint (Fig. 1, sensor cluster 9), and also describes calibrating/recalibrating to perform the zeroing (¶ 0039). Fig. 3 shows multiple sensor clusters 9, but these are not required to be used, as evidenced by Fig. 1C. ¶ 0031 explains that the sensor cluster 9 is located on at least one body part, which suggests that more than one sensor is not necessary. Thus, all claims remain rejected in light of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791