DETAILED ACTION
This action is responsive to the “AMENDMENT AND RESPONSE TO NON-FINAL OFFICE ACTION” filed 11 May 2026. The Examiner acknowledges the amendments to claims 1-4 and 6-17, as well as the cancelation of claim 5. Claims 1-4 and 6-17 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 should read “rotation about[[,]] a longitudinal axis of the femur” [lines 10-11].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-10, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stark (US-20050113652-A1).
Regarding claim 1, Stark teaches
A wearable range of motion detection system, comprising:
a wearable support comprising a waistband [Waist support includes straps 824 or the like to provide for easy fastening and unfastening of waist support 802 (Stark ¶0143, Fig. 20)] and at least one motion detector assembly, the at least one motion detector assembly comprising:
a femoral strut extending between a superior end and an inferior end [frame members 834, 836 (Stark ¶0145, Fig. 20)];
a polyaxial connection between the superior end and the waistband [Hip hinge 804 preferably is a hinge capable of motion in multiple planes. Suitable instrumented hinges with motion in multiple planes were described above. Preferred hip hinges 804 provide for motion of the leg forward-to-back as well as side-to-side, when the hinge is unlocked (Stark ¶0144, Fig. 20); Hinge link 830 provides rigid support between hip hinge 804 and support segment 832… Frame members 834, 836 provide rigid connection between support segment 832 and knee hinge 808 (Stark ¶0145, Fig. 20)];
hip sensors in motion sensing communication with the polyaxial connection, configured to capture data reflecting movement of the femur with respect to a hip in a medial-lateral direction, anterior-posterior direction and rotation about, longitudinal axis of the femur [Full leg brace 800 preferably includes a plurality of transducers. As depicted in FIG. 20, strain gauge 900 is associated with hinge link 822. Strain gauge 902 is associated with frame member 834. Strain gauge 904 is associated with frame segment 884. Strain gauges 900, 902 and 904 can supply measurements related to forces applied against a locked hinge or related to rotation of hip hinge 804, knee hinge 808, and/or ankle hinge 812. Hip hinge 804 preferably includes a multidimensional position sensor 906, as described above. Hinge element 840 of knee hinge 808 preferably includes a position sensor, 908, to measure the orientation of knee hinge 808. Similarly, hinge element 880 of ankle hinge 812 preferably includes a position sensor, 910 (Stark ¶0151, Fig. 20); The support structure includes one or more hinges that provide for motion of the joint in multiple planes of motion. Position sensors preferably provide for measurements of the position of the hinge in the multiple planes of motion. The hinge or hinges preferably provide for the measurement of the motion about two or more planes of motion (Stark ¶0059, emphasis applied), wherein measured motion about more than two planes (three planes) is considered to include movement of the femur in the medial-lateral (considered equivalent to measuring roll) and anterior-posterior (considered equivalent to measuring pitch) directions, as well as rotation about a longitudinal axis of the femur (considered equivalent to measuring yaw), based on the hip hinge 804 being described as allowing for motion in multiple planes, and further based on the plain definition of a “hinge” referring to “a jointed or flexible device on which a door, lid, or other swinging part turns” (https://www.merriam-webster.com/dictionary/hinge)].
Regarding claim 2, Stark teaches
The wearable range of motion detection system as in Claim 1, comprising a left leg motion detector assembly and a right leg motion detector assembly [The brace shown in FIG. 20 is intended to be worn on the patient's left leg. A corresponding brace can be constructed for the patient's right leg based on this design by connecting the leg portion of the brace to the other side of waste support section 820. The leg portion can be identical in construction to the left leg version shown in FIG. 20, or the leg portion can involve reversal of the left and right hand elements on the leg portion, such that the resulting right leg portion corresponds to the left leg portion reflected through a symmetry plane going through the center of the leg portion. Furthermore, a lower extremity brace that supports both of the patient's legs can be constructed with a single waste support section 820 connected through two hip hinges 804 to appropriate supports for both legs (Stark ¶0153)].
Regarding claim 6, Stark teaches
The wearable range of motion detection system as in Claim 1, further comprising a foot attachment, for securing a tibial strut with respect to a wearer’s foot [Foot rest 816 includes a heel support 890 and foot strap 892. Heel support 890 is contoured to the fit the rear portion of a patient's foot. Foot strap 892 wraps around the patient's foot to secure the patient's foot against heel support 890 (Stark ¶0150, Fig. 20)].
Regarding claim 7, Stark teaches
The wearable range of motion detection system as in Claim 6, further comprising at least one sensor for measuring pronation of the foot [ankle hinge 812 includes hinge elements 880, 882, connected respectively to frame elements 850, 852. Several suitable designs for instrumented hinge elements 880, 882 are described above (Stark ¶0148, Fig. 20); Stark ¶¶0059, 0151, see Examiner’s analysis of claim 1 regarding measurement of motion in multiple planes].
Regarding claim 8, Stark teaches
The wearable range of motion detection system as in Claim 6, further comprising at least one sensor for measuring flexion or extension of the foot [Stark ¶¶0059, 0148, 0151, see Examiner’s analysis of claim 1 regarding measurement of motion in multiple planes].
Regarding claim 9, Stark teaches
The wearable range of motion detection system as in Claim 6, further comprising at least one sensor for measuring rotation of the foot [Stark ¶¶0059, 0148, 0151, see Examiner’s analysis of claim 1 regarding measurement of motion in multiple planes].
Regarding claim 10, Stark teaches
The wearable range of motion detection system as in Claim 3, wherein a length of the femoral strut between the waistband and the knee attachment is adjustable [Frame members 834, 836 can be designed to have adjustable lengths to provide a proper fit (Stark ¶0145)].
Regarding claim 16, Stark teaches
The wearable range of motion detection system as in Claim 1, wherein the hip sensors are configured to collect angular position and time data [Stark ¶0151; The preliminary analysis, if any, performed by the controller can include grouping and/or averaging of groups of exercises over certain periods of time and/or performed at particular times of the day. Thus, raw or analyzed data can be transferred. This analysis can involve an evaluation of variation with the progress of time to assist the health care professional evaluate whether the patient is making sufficient improvement and to evaluate whether the exercise routine programmed into the controller is appropriate (Stark ¶0176)].
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(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stark, as applied to claim 1, in view of Shim (US-20150231018-A1, previously presented).
Regarding claim 3, Stark teaches
The wearable range of motion detection system as in Claim 1.
However, while Stark discloses and depicts a thigh attachment configured to secure the superior end of the femoral strut with respect to a thigh [Stark ¶0145, Fig. 20], Stark fails to explicitly disclose further comprising a knee attachment configured to secure the inferior end of the femoral strut with respect to a knee.
Shim discloses a wearable range of motion detection system comprising: a wearable support comprising a waistband [second waist fixing unit 12 (Shim ¶0089, Figs. 1-2)] and a femoral strut [first link 22 (Shim ¶0065, Figs. 1-2), wherein as depicted in Figs. 1-2, the first link 22 is considered to extend from a superior end (towards first joint 21) and an inferior end (towards second joint 31)] coupled via a polyaxial connection [first joint 21 (Shim ¶0065, Figs. 1-2); For example, as the first joint 21 is rotated in front and rear directions of the wearer, the first link 22 is rotated by drawing a circular arc on a plane (hereinafter referred to as an "x-y plane") formed by the x and y axes with respect to the first joint 21. In addition, the femoral region of the wearer may be rotated on the x-y plane with respect to the first joint 21 in the same direction as the rotation direction of the first link 22. As another example, as the first joint 21 is rotated in left and right directions of the wearer, the first link 22 is rotated by drawing a circular arc on a plane (hereinafter referred to as a "y-z plane") formed by the y and z axes with respect to the first joint 21. In addition, the femoral region of the wearer may be rotated on the y-z plane with respect to the first joint 21 in the same direction as the rotation direction of the first link 22 (Shim ¶0070), wherein rotation in each of the x-y and the y-z plane as defined in Fig. 2 is considered to read on the joint being a polyaxial connection]; wherein Shim further discloses a knee attachment configured to secure the inferior end of the femoral strut with respect to a knee [a first fixing unit 23 for fixing the first link 22 to the femoral region of the wearer may be provided in an inner side or an outer side of the first link 22 (Shim ¶0069); the first fixing unit 23 may be made of a metal material, an elastic material such as rubber and the like. The first fixing unit 23 may be implemented in the form of a chain as shown in FIG. 1, in the form of a band with elasticity, or in the form of a strap, however example embodiments are not limited thereto. For example, various fixing means which can be considered by those skilled in the art in order to fix the first link 22 to the femoral region or the like may be included in an example of the first fixing unit 23 (Shim ¶0072, Figs. 1-2); at least one second fixing unit 33 and 34 for fixing the second link 32 to the lower thigh region of the wearer may be provided in an inner side or an outer side of the second link 32 (Shim ¶0076), wherein the first fixing unit 23 and the second fixing unit 33 together are considered to form a knee attachment that is considered to secure the inferior end of the femoral strut (the end of the first link 22 towards the second joint 31) relative to a wearer’s knee].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Stark to employ further comprising a knee attachment configured to secure the inferior end of the femoral strut with respect to a knee, so as to allow for secured attachment of the femoral strut to the wearer, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [attachment of a wearable support to a wearer] [MPEP § 2143(I)(D)].
Regarding claim 4, Stark in view of Shim teaches
The wearable range of motion detection system as in Claim 3, wherein the knee attachment comprises a flexible cuff [Shim ¶¶0069, 0072, 0076, wherein disclosure of the first fixing unit 23 and the second fixing unit 33 each comprising a band with elasticity is considered to read on the broadest reasonable interpretation of a flexible cuff].
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stark, as applied to claim 10, in view of Wang (US-20200281745-A1).
Regarding claim 11, Stark teaches
The wearable range of motion detection system as in Claim 10.
However, Stark fails to explicitly disclose wherein the femoral strut comprises first and second telescopically extendable components.
Wang discloses an exoskeleton system comprising a wearable support comprising a femoral strut, wherein the femoral strut comprises first and second telescopically extendable components such that a length of the femoral strut is adjustable [Each of the telescopic thigh bars 7 consists of an upper thigh bar 12 and a lower thigh bar 13. The upper thigh bar 12 and the lower thigh bar 13 are both made of aluminum tubes, three rows of threaded through holes are formed on an upper end of the lower thigh bar 13 in one row, and the upper end of the lower thigh bar 13 is connected with a bottom end of the upper thigh bar 12 via the threaded through holes and bolts to realize the stepped length adjustment of the telescopic thigh bar 7 (Wang ¶0027, Fig. 1)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Stark to employ wherein the femoral strut comprises first and second telescopically extendable components, as this modification would amount to mere simple substitution of one known element [length adjustment mechanism of Stark] for another [telescopic elements of Wang for length adjustment] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 12, Stark in view of Wang teaches
The wearable range of motion detection system as in Claim 11, wherein the first and second components are tubular [Wang ¶0027, Fig. 1].
Regarding claim 13, Stark in view of Wang teaches
The wearable range of motion detection system as in Claim 12, further comprising a knee module carried by the knee attachment [Strain gauges 900, 902 and 904 can supply measurements related to forces applied against a locked hinge or related to rotation of hip hinge 804, knee hinge 808, and/or ankle hinge 812. Hip hinge 804 preferably includes a multidimensional position sensor 906, as described above. Hinge element 840 of knee hinge 808 preferably includes a position sensor, 908, to measure the orientation of knee hinge 808 (Stark ¶0151, Fig. 20)].
Regarding claim 14, Stark in view of Wang teaches
The wearable range of motion detection system as in Claim 13, comprising at least one sensor in the knee module, configured to measure flexion and extension at the knee [Stark ¶0151, Fig. 20].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stark in view of Wang, as applied to claim 14, in further view of Goldfarb (US-20140142475-A1, previously presented).
Regarding claim 15, Stark in view of Wang teaches
The wearable range of motion detection system as in Claim 14.
However, Stark in view of Wang fails to explicitly disclose further comprising electrical conductors extending through the femoral strut.
Stark does disclose wired communication between the sensor(s) of the system with a controller [The transducers are preferably connected to controller 818, generally by wires (Stark ¶0152, Fig. 20)].
Goldfarb discloses a wearable physical therapy system comprising an exoskeleton configured to be coupled to a wearer’s hips, thigh, and shank, wherein Goldfarb discloses extending electrical conductors within an interior of structural elements of the exoskeleton [As noted above, the connectors 112R, 112L, 114R, and 114L can be configured to provide mechanical and electrical connections. Referring back to FIG. 5B, in the event that an electrical connection is needed between the thigh segment 108R and shank segment 106R, wires can be routed through the interior of connector 112R to electrical contacts 530. A corresponding set of electrical contacts (not shown) would also be provided in the interior of receiving element 506 (Goldfarb ¶0052, Fig. 2, 5B)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Stark in view of Wang to employ further comprising electrical conductors extending through the femoral strut, as this modification would amount to mere simple substitution of one known element [wired/wireless connection of Shim] for another [wired connection through interior of structure] with similar expected results [wired connection] [MPEP § 2143(I)(B)].
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stark, as applied to claim 16, in view of Sankai (US-20100121232-A1).
Regarding claim 17, Stark teaches
The wearable range of motion detection system as in Claim 16.
However, Stark fails to explicitly disclose wherein the hip sensors comprise a rotary encoder.
Sankai discloses a wearable physical therapy system for measuring a joint angle between a hip and a femur, wherein Takahashi discloses the use of a rotary encoder for collecting angular position data [Furthermore, each of the driving motors 120, 122, 124, and 126 has the angle detecting unit 24-1 (24-2). For example, an angle sensor is used as the angle detecting unit 24-1 (24-2). The angle sensor is, for example, a rotary encoder for counting the number of pulses proportional to the joint angle of each of the first joint 164 and the second joint 166, and outputting, as the sensor output, electric signals in accordance with the number of pulses corresponding to the joint angles (Sankai ¶0144, Fig. 3)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Stark to employ wherein the hip sensors comprise a rotary encoder, as this modification would amount to mere simple substitution of one known element for another with similar expected results [MPEP § 2143(I)(B)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 6, filed 11 May 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6, with respect to the previously presented claim objections have been fully considered and are persuasive. The objections to claims 1-17 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejections of claims 5, 16-17, and those dependent therefrom under § 112(b) have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-8, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 102 and § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Stark (US-20050113652-A1).
The Applicant asserts that while the previously applied Shim reference discloses front, back, left and right movement of the lower extremity, Shim does not disclose or suggest the Applicant’s claimed diagnostic system, which does not provide any mechanical assistance and measures femoral rotation about the “longitudinal axis of the femur” as recited in amended claim 1. The Applicant further asserts that Shim does not disclose or suggest “rotation” of the femur about its own longitudinal axis and only refers to “rotation” of the femur about the medial-lateral axis of rotation at the hip during normal anterior-posterior movement and side stepping movement in which the lower extremity moves in a medial-lateral direction. The Applicant also asserts that in contrast to Shim’s objective of providing a walking assistance throughout the primarily anterior-posterior arc of the stride, the Applicant’s claimed diagnostic system pursues the completely different objective of collecting performance data [particularly femoral and/or tibial rotation about the longitudinal axis of the bone], which the Applicant notes can be important in evaluating physical therapy protocols and monitoring responsive progress of the patient to those protocols. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Stark discloses a wearable range of motion detection system comprising a polyaxial connection between a waistband and a motion detector assembly that allow for measurement of movement of the femur with respect to a hip in a medial-lateral direction, anterior-posterior direction and rotation about a longitudinal axis of the femur for the purposes of collecting performing data during physical therapy/rehabilitation [Stark ¶¶0059, 0143-0145, 0151, Fig. 20, wherein measured motion about more than two planes (three planes) is considered to include movement of the femur in the medial-lateral (considered equivalent to measuring roll) and anterior-posterior (considered equivalent to measuring pitch) directions, as well as rotation about a longitudinal axis of the femur (considered equivalent to measuring yaw), based on the hip hinge 804 being described as allowing for motion in multiple planes, and further based on the plain definition of a “hinge” referring to “a jointed or flexible device on which a door, lid, or other swinging part turns” (https://www.merriam-webster.com/dictionary/hinge)]. The Examiner further notes that in response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a diagnostic system that “does not provide any mechanical assistance”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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