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
In response to amendments, filed November 5, 2025, claims 1, 3, 12, and 18-20 have been amended. No additional claims have been cancelled or added. Claims 1-3 and 12-20 are pending.
Response to Arguments
Applicant's arguments, see Remarks, filed November 5, 2025, with respect to the objection to the specification have been fully considered and are persuasive in view of the amendments. The objection to the specification has been withdrawn.
Applicant's arguments with respect to the claim objections have been fully considered but they are not persuasive. The objection to claim 3 has been resolved, but the objection to claim 12 has not been addressed.
Applicant’s arguments with respect to the prior art rejections have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Stein (US 20140288464 A1)/Krippner (US 8726741 B2)/Kim (US 20180160940 A1).
Claim Objections
Claim 12 is objected to because of the following informalities: for clarity, “each of the first plurality of strain gauge sensors and the second plurality of strain gauge sensors comprising” should be “each of the first plurality of strain gauge sensors and each of the second plurality of strain gauge sensors comprising.” Appropriate correction is required.
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.
Claim(s) 1-3 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20140288464 A1) in view of Kim (US 20180160940 A1).
Regarding claim 1, Stein teaches a medical device (prosthetic insert 2700; [0194] “Prosthetic insert 2700 is a component of a joint replacement system that allows articulation of the muscular-skeletal system”; Fig. 27), comprising:
a substrate (interconnect 2718, Fig. 27);
a first plurality of strain sensors mounted along a first longitudinal central axis of the substrate; a second plurality of strain sensors mounted along a second longitudinal central axis of the substrate perpendicular to the first longitudinal central axis; wherein the first plurality of strain sensors are aligned to measure deformation when a load is applied along the second longitudinal central axis ([0199] “Capacitor sensors underlie load pads 2722… The measurements from the three sensors underlying articular surface 2712 can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710”; Fig. 27, see annotated figure below identifying the first and second pluralities of strain sensors and axes).
However, Stein fails to disclose strain sensors in a non-active condition configured to normalize measurements. Kim teaches a method and a system for monitoring a movement of a user, including at least one wearable flexible tactile sensor configured to sense movement of a muscle or bending of a joint at a corresponding location and transmitting a sensed value.
Kim discloses and wherein the second plurality of strain sensors include a non-active condition and are configured to normalize measurements from the first plurality of strain sensors (Fig. 8; [0100] “In an embodiment, the first strain gauge 632a and the first metal wire 632b may correspond to driving sensor modules and the second strain gauge 634a and the second metal wire 634b may correspond to correction sensor modules. For example, the first strain gauge 632a may output a first sensing value via the first metal wire 632b and output a second sensing value for correcting the first sensing value through the second metal wire 634b.” [0103] “In an embodiment, the third strain gauge 636a and the third metal wire 636b may correspond to the driving sensor modules and the fourth strain gauge 638a and the fourth metal wire 638b may correspond to the correction sensor modules. For example, the third strain gauge 636a may output a third sensing value through the first metal wire 636b and the fourth strain gauge 638a may output a fourth sensing value for correcting the third sensing value through the fourth metal wire 638b.” [0110] “In an embodiment, the strain gauges 632a, 634a, 636a, and 638a may be formed in a direction to easily measure the bending force or the normal force… in FIG. 8, the first strain gauge 632a of the driving sensor module and the second strain gauge 634a of the correction sensor module may be formed such that each of the longitudinal axes 810 and 812 has a predetermined angle with a vertical axis of a plane (the axes 810 and 812 have different orientations when viewed over the top, in a direction perpendicular to a major surface of the polymer layer).” [0112] “The third strain gauge 636a of the driving sensor module and the fourth strain gauge 638a of the correction sensor module may be formed such that each of the longitudinal axes 820 and 822 has a predetermined angle with the vertical axis of the plane.”).
Therefore, 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 prosthetic insert of Stein to include a second plurality of strain sensors in a non-active condition and configured to normalize measurements from a first plurality of strain sensors as disclosed in Kim to correct the sensing value output from each driving sensor module for more accurate analysis of a user’s movement (Kim [0110, 0143]).
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Fig. 27 from Stein. Blue highlights a first plurality of strain sensors (blue circles) mounted along a first longitudinal central axis (blue dashed line) of the substrate and green highlights a second plurality of strain sensors (green circles) mounted along a second longitudinal central axis (green dashed line) of the substrate perpendicular to the first longitudinal central axis
Regarding claim 2, the combination of Stein/Kim discloses the medical device of claim 1, further comprising: a plunger (Stein: articular surfaces 2710 and 2712 with respective load plates 2716 and 2718) in contact with each of the first plurality of strain gauge sensors; wherein the plunger comprises a bridge portion in contact with the second plurality of strain sensors along the second longitudinal central axis (Stein: [0199] “Load plate 2720 couples to the capacitor sensors through load pads 2722. Load plate 2720 distributes the load applied to articular surface 2712 to the capacitor sensors at predetermined locations within insert 2700. The measurements from the three sensors underlying articular surface 2712 can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710.” Fig. 27).
Regarding claim 3, the combination of Stein/Kim discloses the medical device of claim 2, wherein the plunger is configured such that when a first force applied to a top side of the plunger, the first force is applied across the second plurality of strain sensors (Stein: [0199] “Load plate 2720 couples to the capacitor sensors through load pads 2722. Load plate 2720 distributes the load applied to articular surface 2712 to the capacitor sensors at predetermined locations within insert 2700. The measurements from the three sensors underlying articular surface 2712 can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710.” Fig. 27).
Regarding claim 18, Stein teaches a medical device (prosthetic insert 2700; [0194] “Prosthetic insert 2700 is a component of a joint replacement system that allows articulation of the muscular-skeletal system”; Fig. 27), comprising:
a lower housing (support structure 2708; Fig. 27);
a circuit board within the lower housing comprising a medial portion and a lateral portion (electronic circuitry 2704, support structure 2708; Fig. 27);
a plurality of strain sensors (capacitor sensors 2100 under load pads 2722) mounted to a substrate, the substrate comprising a central axis (interconnect 2718, Fig. 27).
However, Stein fails to disclose strain sensors in a non-active condition configured to normalize measurements.
Kim discloses wherein the plurality of strain sensors includes first sensors that include an active condition and second sensors that include a non-active condition, wherein the second sensors are configured to normalize measurements from the first sensors (Fig. 8; [0100] “In an embodiment, the first strain gauge 632a and the first metal wire 632b may correspond to driving sensor modules and the second strain gauge 634a and the second metal wire 634b may correspond to correction sensor modules. For example, the first strain gauge 632a may output a first sensing value via the first metal wire 632b and output a second sensing value for correcting the first sensing value through the second metal wire 634b.” [0103] “In an embodiment, the third strain gauge 636a and the third metal wire 636b may correspond to the driving sensor modules and the fourth strain gauge 638a and the fourth metal wire 638b may correspond to the correction sensor modules. For example, the third strain gauge 636a may output a third sensing value through the first metal wire 636b and the fourth strain gauge 638a may output a fourth sensing value for correcting the third sensing value through the fourth metal wire 638b.” [0110] “In an embodiment, the strain gauges 632a, 634a, 636a, and 638a may be formed in a direction to easily measure the bending force or the normal force… in FIG. 8, the first strain gauge 632a of the driving sensor module and the second strain gauge 634a of the correction sensor module may be formed such that each of the longitudinal axes 810 and 812 has a predetermined angle with a vertical axis of a plane (the axes 810 and 812 have different orientations when viewed over the top, in a direction perpendicular to a major surface of the polymer layer).” [0112] “The third strain gauge 636a of the driving sensor module and the fourth strain gauge 638a of the correction sensor module may be formed such that each of the longitudinal axes 820 and 822 has a predetermined angle with the vertical axis of the plane.”).
Therefore, 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 prosthetic insert of Stein to include a second plurality of strain sensors in a non-active condition and configured to normalize measurements from a first plurality of strain sensors as disclosed in Kim to correct the sensing value output from each driving sensor module for more accurate analysis of a user’s movement (Kim [0110, 0143]).
The combination of Stein/Kim discloses and wherein the plurality of strain sensors are in contact with a first surface of a plunger (Stein: articular surfaces 2710 and 2712 with respective load plates 2716 and 2718) and are configured to measure deformation when a load is applied in a direction of the central axis (Stein: [0199] “Load plate 2720 couples to the capacitor sensors through load pads 2722. Load plate 2720 distributes the load applied to articular surface 2712 to the capacitor sensors at predetermined locations within insert 2700. The measurements from the three sensors underlying articular surface 2712 can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710.”).
Regarding claim 19, the combination of Stein/Kim discloses the medical device of claim 18, wherein the plunger further comprises a plurality of bridge portions (Stein: load plates 2716 and 2720 make contact with load pads 2722); wherein each bridge portion of the plurality of bridge portions is in contact with a strain sensor of the plurality of strain sensors (Stein: [0199] “Load plate 2720 couples to the capacitor sensors through load pads 2722. Load plate 2720 distributes the load applied to articular surface 2712 to the capacitor sensors at predetermined locations within insert 2700. The measurements from the three sensors underlying articular surface 2712 can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710.” Fig. 27).
Regarding claim 20, the combination of Stein/Kim discloses the medical device of claim 19, wherein the plunger is configured to distribute force applied to a top side of the plunger across the plurality of strain sensors (Stein: [0199] “Load plate 2720 couples to the capacitor sensors through load pads 2722. Load plate 2720 distributes the load applied to articular surface 2712 to the capacitor sensors at predetermined locations within insert 2700. The measurements from the three sensors underlying articular surface 2712 can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710.” Fig. 27).
Claim(s) 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20140288464 A1) in view of Krippner (US 8726741 B2) and Kim (US 20180160940 A1).
Regarding claim 12, Stein teaches a method of determining a load magnitude and load location at a joint using a medical device (prosthetic insert 2700, [0194] “insert 2700 illustrates a device having a medical sensor for measuring a parameter of the muscular-skeletal system”), the method comprising:
measuring strain at a first plurality of strain gauge sensors and a second plurality of strain gauge sensors; and determining at least one load magnitude and at least one load location based on the measured strain ([0199] “The measurements from the three sensors underlying articular surface 2712 can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710”; [0200] “The relationship between capacitance and force, pressure, or load is known and used to determine the measurement value”; Fig. 27 [first plurality: sensors under load pads 2722 under load plate 2716; second plurality: sensors under load pads 2722 under load plate 2720);
wherein the medical device (prosthetic insert 2700; Fig. 27) comprises:
a lower housing (support structure 2708; Fig. 27);
a circuit board within the lower housing (electronic circuitry 2704; Fig. 27);
the first plurality of strain gauge sensors mounted to a medial portion of the circuit board; the second plurality of strain gauge sensors mounted to a lateral portion of the circuit board; each of the first plurality of strain gauge sensors and the second plurality of strain gauge sensors ([0199] “Capacitor sensors underlie load pads 2722;” Fig. 27; first plurality: sensors beneath load pads 2722 under load plate 2716, the medial portion; second plurality: sensors beneath load pads 2722 under load plate 2720, the lateral portion)
However, Stein fails to disclose each strain gauge sensor having a plurality of strain sensors. Krippner teaches a multiaxial force/torque sensor assembly in mechanical contact with a printed circuit board.
Krippner discloses comprising:
a first plurality of strain sensors mounted along a first longitudinal central axis of a substrate; a second plurality of strain sensors mounted along a second longitudinal central axis of the substrate perpendicular to the first longitudinal central axis (Fig. 7, see annotated figure below. Col 7, lines 40-42 “of the transducer body 31, while with the other set of transducer modules 34, the strain gauges 16 are fixed on the top surface”).
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Fig. 7 from Krippner. Blue highlights a first plurality of strain sensors (blue rounded rectangles) mounted along a first longitudinal central axis (blue dashed line) of the substrate and green highlights a second plurality of strain sensors (green circles) mounted along a second longitudinal central axis (green dashed line) of the substrate perpendicular to the first longitudinal central axis
Therefore, 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 prosthetic insert of Stein to include each strain gauge sensor having a plurality of strain sensors as disclosed in Krippner to allow for measurement of forces and torques in all axis directions (Krippner Col 7, lines 39-43).
However, the combination of Stein/Krippner fails to disclose strain sensors in a non-active condition configured to normalize measurements.
Kim discloses wherein the second plurality of strain sensors include a non-active condition and are configured to normalize measurements from the first plurality of strain sensors (Fig. 8; [0100] “In an embodiment, the first strain gauge 632a and the first metal wire 632b may correspond to driving sensor modules and the second strain gauge 634a and the second metal wire 634b may correspond to correction sensor modules. For example, the first strain gauge 632a may output a first sensing value via the first metal wire 632b and output a second sensing value for correcting the first sensing value through the second metal wire 634b.” [0103] “In an embodiment, the third strain gauge 636a and the third metal wire 636b may correspond to the driving sensor modules and the fourth strain gauge 638a and the fourth metal wire 638b may correspond to the correction sensor modules. For example, the third strain gauge 636a may output a third sensing value through the first metal wire 636b and the fourth strain gauge 638a may output a fourth sensing value for correcting the third sensing value through the fourth metal wire 638b.” [0110] “In an embodiment, the strain gauges 632a, 634a, 636a, and 638a may be formed in a direction to easily measure the bending force or the normal force… in FIG. 8, the first strain gauge 632a of the driving sensor module and the second strain gauge 634a of the correction sensor module may be formed such that each of the longitudinal axes 810 and 812 has a predetermined angle with a vertical axis of a plane (the axes 810 and 812 have different orientations when viewed over the top, in a direction perpendicular to a major surface of the polymer layer).” [0112] “The third strain gauge 636a of the driving sensor module and the fourth strain gauge 638a of the correction sensor module may be formed such that each of the longitudinal axes 820 and 822 has a predetermined angle with the vertical axis of the plane.”).
Therefore, 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 combination of Stein/Krippner to include a second plurality of strain sensors in a non-active condition and configured to normalize measurements from a first plurality of strain sensors as disclosed in Kim to correct the sensing value output from each driving sensor module for more accurate analysis of a user’s movement (Kim [0110, 0143]).
The combination of Stein/Krippner/Kim further discloses:
an upper housing coupled to the lower housing (Stein: [0203] “The support structures 2706 and 2708 can be temporarily or permanently coupled;” Fig. 27); and
a first plunger (Stein: articular surface 2710 and load plate 2716) received by the upper housing and adjacent to the first plurality of strain gauge sensors (Stein: [0199] “sensors underlie load pads 2722;” Fig. 27); and a second plunger (Stein: articular surface 2712 and load plate 2720) received by the upper housing and adjacent to the second plurality of strain gauge sensors (Stein: [0200] A force, pressure, or load applied by the muscular-skeletal system is coupled to the articular surfaces 2710 and 2712 of prosthetic component insert 2700, which respectively couples to plates 2716 and 2720… each capacitor elastically compresses due to the force, pressure, or load; [0178] capacitor 2100 can be used as a force, pressure, or load sensor for the muscular-skeletal system).
Regarding claim 13, the combination of Stein/Krippner/Kim discloses the method of claim 12, wherein the first plunger further comprises a first plurality of bridge portions; wherein the second plunger further comprises a second plurality of bridge portions (Stein: load plates 2716 and 2720 make contact with 2722; Fig. 27); wherein each bridge portion of the first plurality of bridge portions is in contact with a strain gauge sensor of the first plurality of strain gauge sensors; and wherein each bridge portion of the second plurality of bridge portions is in contact with a strain gauge sensor of the second plurality of strain gauge sensors (Stein: [0199] “A load plate 2716 underlies articular surface 2710. Similarly, a load plate 2720 underlies articular surface 2712… Load plate 2720 distributes the load applied to articular surface 2712 to the capacitor sensors at predetermined locations within insert 2700”; Fig. 27).
Regarding claim 14, the combination of Stein/Krippner/Kim discloses the method of claim 13, wherein the first plurality of strain gauge sensors are positioned to define a medial polygon; wherein vertices of the medial polygon are at center points of each of the first plurality of strain gauge sensors; wherein the second plurality of strain gauge sensors are positioned to define a lateral polygon between them; and wherein vertices of the lateral polygon are at center points of each of the second plurality of strain gauge sensors (Stein: [0199] “Capacitor sensors underlie load pads 2722 in the vertices of the triangular shaped interconnect 2718 in support structure 2708;” under load plate 2716 is medial and under load plate 2720 is lateral; Fig. 27).
Regarding claim 15, the combination of Stein/Krippner/Kim discloses the method claim 14, further comprising: measuring a first load applied to the first plunger by measuring a first strain on each of the strain gauge sensors that define the medial polygon; and measuring a second load applied to the second plunger by measuring a second strain on each of the strain gauge sensors that define the lateral polygon (Stein: [0199] “The measurements from the three sensors underlying articular surface 2712 can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710”; Fig. 27; first plurality: sensors under load pads 2722 under load plate 2716 define the medial polygon; second plurality: sensors under load pads 2722 under load plate 2720 define the lateral polygon).
Regarding claim 16, the combination of Stein/Krippner/Kim discloses the method of claim 15, further comprising: determining a medial load magnitude and a medial load location on the first plunger from the first strain; and determining a lateral load magnitude and lateral load location on the second plunger from the second strain (Stein: [0199] “The measurements from the three sensors underlying articular surface 2712 [lateral] can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710 [medial]; [0200] The relationship between capacitance and force, pressure, or load is known and used to determine the measurement value”; Fig. 27).
Regarding claim 17, the combination of Stein/Krippner/Kim discloses the method of claim 16, further comprising: displaying the medial load magnitude, medial load location, lateral load magnitude, and lateral load location on a graphical user interface (GUI) (Stein: [0199] “The measurements from the three sensors underlying articular surface 2712 [lateral] can be used to determine the location of the applied load to insert 2700. Load plate 2716 operates similarly underlying articular surface 2710 [medial]”; [200] “the measurement data can be processed and transmitted to a receiver external to insert 2700 for display and analysis”).
Conclusion
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791