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 amendment filed October 1, 2025 has been entered. Claims 1-4, 6-11, and 13-14 remain pending in the application, and claims 5 and 12 were previously cancelled. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 102 and 103 Rejections below.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7-11, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120179020 A1 (Wekell, William Oren).
Regarding claim 1, Wekell teaches a measurement apparatus capable of measuring an amount of edema of a limb (Abstract: “sensor assembly configured to detect a measurement indicating a distance around the patient's limb and at least one processor configured to detect whether the distance around the patient's limb has increased indicating edema”), the measurement apparatus comprising:
a sensor that has a sheet shape ([0111] “the sensor portion 1515 extends under the first end portion 1312 of the strap 1310”), is configured to freely expand and contract in one direction that intersects a thickness direction of the sensor ([0114] “the calculated values for the sensors 450 and 460 will vary based on the positioning of the sensors 450 and 460 relative to the first and second gradient portions "G1" and "G2," respectively, along the gradient direction (indicated by the arrow "GD").”; Fig. 10B), and is capable of detecting change in an electrical characteristic in association with expansion or contraction ([0201] “While the sensors 450, 455, and 460 have been described as being light sensors, those of ordinary skill in the art appreciate that embodiments may be constructed using other types of sensors, such as linear variable resistors, rotary variable resistors, pressure sensors, strain sensors, magnetoresistive circuits, conductive fabric, conductive elastomers, and the like”);
a support member ([0185] “strap 1310”) having a first connection portion that is attached to a first end portion of the sensor ([0185] “the first end portion 1312 of the strap 1310 is connected to the frame member 1337”) and a second connection portion that is attached to a second end portion of the sensor ([0185] “the second end portion 1314 of the strap 1310 is connected to the guide portion 1315 of the frame member 1337.”), and that is configured to surround the limb together with the sensor in a mounted state in which the measurement apparatus is configured to be mounted on the limb ([0112] “the strap 1310 is wrapped snuggly about a tapered object (e.g., a wrist, an ankle, and the like), the strap 1310 will follow the tapered surface of the object”; [0196] “The width of the strap 1310 may be selected such that the strap intimately and contiguously follows the surface of the limb 11 and at the same time properly places the sensors 450, 455, and 460 relative to the optical gradient 1545.”);
an adjusting member that is disposed on the support member and is configured to adjust a length of a part of the support member ([0111] “The first end portion 1312 is coupled to the electronics enclosure 1335 by a tensioning member 1320”; [0190] “The tensioning member 1320 may be coupled to the hook 1330 of the frame member 1337. Tension in the tensioning member 1320 pulls the first end portion 1312 toward the electronics enclosure 1335 to thereby impart tension in the strap 1310, which may hold the strap 1310 snuggly against the limb 11.”); and
a restricting member (Fig. 17; [0187] “guide portion 1315”) that is attachable to the support member and is detachable from the support member and is configured to, in a state of being attached to the support member, prevent the first connection portion and the second connection portion from moving relative to one another in a longitudinal direction to thereby keep the sensor at a reference length in an expansion-contraction direction of the sensor while the length of the part of the support member is adjusted by the adjusting member ([0186] “A guide 1340 spaced apart from the tensioning member 1320 may also be adhered to the first end portion 1312 of the strap 1310 by the adhesive material 1345. The guide 1340 may be configured to limit lateral movement of the first end portion 1312 of the strap 1310 to help maintain the optical gradient 1545 adjacent the sensors 450, 455, and 460, even when the device 10 is positioned on a portion of the patient's limb 11 (see FIG. 1) at a location of extreme taper”).
Regarding claim 2, Wekell teaches the measurement apparatus according to claim 1, wherein the sensor includes
a base containing an elastomer material ([0201] “the sensors 450, 455, and 460 have been described as being light sensors, those of ordinary skill in the art appreciate that embodiments may be constructed using other types of sensors… conductive elastomers”), and
an electrically-conductive layer that is stacked in the thickness direction of the base and freely expands and contracts integrally with the base ([0110] “The electronics enclosure 1335 includes a sensor portion 1515”; [0184] ‘The electronics enclosure 1335 includes a body portion 1540 and a transparent cover 1810. The body portion 1540 may include a compliant, elastomeric portion 1535 that is positioned against the patient's limb 11 when the device 10 is worn”; Fig. 17).
Regarding claim 3, Wekell teaches the measurement apparatus according to claim 1, wherein the support member and the sensor are configured to be annularly disposed around the limb in the mounted state ([0112] “when the strap 1310 is wrapped snuggly around a cylinder”)
Regarding claim 4, Wekell teaches the measurement apparatus according to claim 1, wherein the support member is configured to be disposed in a spiral manner around the limb in the mounted state ([0186] “when the device 10 is positioned on a portion of the patient's limb 11 (see FIG. 1) at a location of extreme taper.”).
Regarding claim 7, Wekell teaches the measurement apparatus according to claim 1, wherein a plurality of protrusions that are configured to protrude toward the limb are disposed, so as to be spaced apart from each other and aligned in the longitudinal direction of the support member, on a surface that is configured to face the limb in the support member in the mounted state (Fig. 15 depicts the optical gradient 1545 and the body portion 1540 of the electronics enclosure protruding toward the limb and being spaced apart from one another and aligned in a longitudinal direction when the strap is mounted on the limb).
Regarding claim 8, Wekell teaches the measurement apparatus according to claim 1, wherein the support member is composed of a material with a higher modulus of elasticity than the sensor ([0109] “the device 10 includes a flexible but inelastic strap 1310”; [0184] “The electronics enclosure 1335 includes a body portion 1540 and a transparent cover 1810. The body portion 1540 may include a compliant, elastomeric portion 1535 that is positioned against the patient's limb 11 when the device 10 is worn.”; [0201] “While the sensors 450, 455, and 460 have been described as being light sensors, those of ordinary skill in the art appreciate that embodiments may be constructed using other types of sensors, such as … conductive elastomers”; The sensor comprises an elastomer, which has a very low modulus of elasticity compared to the inelastic strap (support member)).
Regarding claim 9, Wekell teaches the measurement apparatus according to claim 1, wherein
a pair of recess parts are positioned in the support member to face each other, each recess part defining a recess in a long axis direction of the limb in the mounted state and being configured to abut against a projecting part of the limb ([0112] “when the strap 1310 is wrapped snuggly about a tapered object (e.g., a wrist, an ankle, and the like), the strap 1310 will follow the tapered surface of the object and the edges 1316 and 1318 the first and second end portions 1312 and 1314, respectively, will not be substantially parallel with one another. In other words, an angle ".theta." is defined between the edges 1316 and 1318 when the strap 1310 is wrapped snuggly about a tapered object (e.g., a wrist, an ankle, and the like).”; Figs. 15-16 depict the optical gradient 1545 and the body portion 1540 of the electronics enclosure protruding toward the limb and creating a pair of recess parts or gaps/openings abutting the limb in the mounted state).
Regarding claim 10, Wekell teaches a method of measuring an amount of edema of a limb (Abstract: “sensor assembly configured to detect a measurement indicating a distance around the patient's limb and at least one processor configured to detect whether the distance around the patient's limb has increased indicating edema”), comprising:
winding a sensor and a support member around a limb of a patient ([0111] “the sensor portion 1515 extends under the first end portion 1312 of the strap 1310”), said sensor having a sheet shape and being configured to freely expand and contract in one direction that intersects a thickness direction of the sensor ([0114] “the calculated values for the sensors 450 and 460 will vary based on the positioning of the sensors 450 and 460 relative to the first and second gradient portions "G1" and "G2," respectively, along the gradient direction (indicated by the arrow "GD").”; Fig. 10B), said support member having a first connection portion that is attached to a first end portion of the sensor in an expansion contraction direction ([0185] “the first end portion 1312 of the strap 1310 is connected to the frame member 1337”) and a second connection portion that is attached to a second end portion of the sensor ([0185] “the second end portion 1314 of the strap 1310 is connected to the guide portion 1315 of the frame member 1337.”),, so that the support member and the sensor together surround the limb ([0112] “the strap 1310 is wrapped snuggly about a tapered object (e.g., a wrist, an ankle, and the like), the strap 1310 will follow the tapered surface of the object”; [0196] “The width of the strap 1310 may be selected such that the strap intimately and contiguously follows the surface of the limb 11 and at the same time properly places the sensors 450, 455, and 460 relative to the optical gradient 1545.”),
detecting a change in an electrical characteristic of the sensor in association with expansion or contraction or the sensor to thereby detect a change in circumferential length of the limb ([0201] “While the sensors 450, 455, and 460 have been described as being light sensors, those of ordinary skill in the art appreciate that embodiments may be constructed using other types of sensors, such as linear variable resistors, rotary variable resistors, pressure sensors, strain sensors, magnetoresistive circuits, conductive fabric, conductive elastomers, and the like”; [0069] “The method collects data using the sensor 450, 455, and 460 that is subsequently used by the control system 220 to obtain a circumference measurement.”; [0115]);
adjusting a length of a part of the support member by an adjusting member that is disposed on the support member ([0111] “The first end portion 1312 is coupled to the electronics enclosure 1335 by a tensioning member 1320”; [0190] “The tensioning member 1320 may be coupled to the hook 1330 of the frame member 1337. Tension in the tensioning member 1320 pulls the first end portion 1312 toward the electronics enclosure 1335 to thereby impart tension in the strap 1310, which may hold the strap 1310 snuggly against the limb 11.”); and
preventing the first connection portion and the second connection portion from moving relative to one another in a longitudinal direction to thereby keep the sensor at a reference length in an expansion-contraction direction of the sensor while the length of the part of the support member is adjusted by the adjusting member by a restricting member that is attachable to the support member and is detachable from the support member and is in a state of being attached to the support member (Fig. 17; [0187] “guide portion 1315”; 0186] “A guide 1340 spaced apart from the tensioning member 1320 may also be adhered to the first end portion 1312 of the strap 1310 by the adhesive material 1345. The guide 1340 may be configured to limit lateral movement of the first end portion 1312 of the strap 1310 to help maintain the optical gradient 1545 adjacent the sensors 450, 455, and 460, even when the device 10 is positioned on a portion of the patient's limb 11 (see FIG. 1) at a location of extreme taper”).
Regarding claim 11, Wekell teaches the method according to claim 10, wherein the sensor includes an electrically-conductive layer, and the detecting comprises detecting a change in capacitance of the electrically-conductive layer ([0057] “the circuit 400 may include a capacitive sensor 1530 (see FIG. 15) configured to detect the presence of the limb 11”; [0061] “The processor 435 analyzes the digital signal and determines whether the capacitive sensor 1530 detected the presence of the limb 11.”).
Regarding claim 13, Wekell teaches the method according to claim 10, further comprising electrically detecting the length of the part of the support member ([0115] “Where the detectors "D1," "D2," and "D3" are positioned relative to the optical gradient 1545 varies with the distance around the patient's limb 11 (or the limb's circumference) in the location on the limb whereat the device 10 is positioned. Therefore, the calculated values may be used as the measure the distance around the patient's limb 11 in the model”).
Regarding claim 14, Wekell teaches the method according to claim 10, further comprising abutting a recess part formed in the support member against a projecting part of the limb ([0112] “when the strap 1310 is wrapped snuggly about a tapered object (e.g., a wrist, an ankle, and the like), the strap 1310 will follow the tapered surface of the object and the edges 1316 and 1318 the first and second end portions 1312 and 1314, respectively, will not be substantially parallel with one another. In other words, an angle ".theta." is defined between the edges 1316 and 1318 when the strap 1310 is wrapped snuggly about a tapered object (e.g., a wrist, an ankle, and the like).”; The space (recess) created by strap wrapped around the limb is modified to accommodate the shape of the limb in a snug manner).
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 20120179020 A1 (Wekell, William Oren) in view of US 20200093378 A1 (Lange et al.)
Regarding claim 6, Wekell teaches the measurement apparatus according to claim 1.
Wekell does not explicitly teach wherein the adjusting member includes a length detecting part capable of electrically detecting the length of the part that is configured to surround the limb in the support member.
However,
Lange teaches wherein the adjusting member includes a length detecting part capable of electrically detecting the length of the part that is configured to surround the limb in the support member ([0064] “With reference to FIGS. 9a and 9b, the skin 311 of the wrist 310 is surrounded by the segment of conductive elastomer 313 and a box 312 containing the electronic elements of the equipment as well as a clamping member 316. The clamping member 316 comprises a motor 315 which, by means of a clamping ring 314, allows a movement of the segment of conductive elastomer at its end 313B, thus adjusting its length, the other end 313B being fixed to the box 312. The motor 315 may be controlled by the data processing system 4, and will cause the tightening or slackening of the elastomer segment 313 to its optimum tension”)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the adjustment member to include a length detecting part. One would have been motivated to make this modification because the clamping member is capable of measuring and adjusting the length of the bracelet to measure the circumference of the body member, as suggested by Lange [0031].
Response to Arguments
Applicant's arguments filed October 1, 2025 have been fully considered but they are not persuasive. With respect to the 102 Rejections in the Non-Final Office Action (See Pages 6-7 of Applicant’s Response), Applicant argues that the guide taught by Wekell is not described as keeping a sensor at a reference length in an expansion-contraction direction of the sensor, and therefore does not correspond to a restricting member as recited. The amended limitation recites preventing the first connection portion and the second connection portion from moving relative to one another in a longitudinal direction to thereby keep the sensor at a reference length in an expansion-contraction direction of the sensor. Applicant argues that Wekell’s guide only limits lateral movement.
MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation (BRI), the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim.
Under BRI, a “longitudinal direction” is a relative term, as the longitudinal direction could be a length in any direction with respect to any axis. Since there is no defined axis to specify which direction is the longitudinal direction, the prevention of lateral movement taught by Wekell reads on the claim language of claims 1 and 10 under BRI.
Claims 4-3, 6-9, 11, and 13-14 are rejected because the rejections of claims 1 and 10 are proper and the prior art teaches or suggests all the features of these amended claims for the reasons described in the 102 and 103 Rejections.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791