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
Examiner acknowledges the reply filed on 11/10/2025 in which claims 10-11 have been amended. Claims 25 have been added. Currently claims 1-16, 18, 19, 25 are pending for examination in this application.
Claim Rejections - 35 USC § 103
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 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) 1-6, 8, is/are rejected under 35 U.S.C. 103 as being unpatentable over Bushara (US20150209216), in view of Malhi et al. (US20140094726), hereafter Malhi.
Regarding Claim 1, Bushara discloses a device (Fig. 2, a device 20B), comprising: an insole assembly (See Fig. A) comprising a first bladder (Fig. 2, trigger chamber 26D; See Fig. A); and a force actuation system (See Fig. A) comprising the first bladder and a second bladder (Fig. 2, stimulation chamber 30D; See Fig. A)
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Fig. A, Adapted from Bushara Fig. 2
Bushara is silent on a tube assembly with a three-way junction connector defining an inlet
However, Malhi teaches a compression device (Fig. 13, compression system 310), comprising of a first bladder (Fig. 13, inflatable chamber 326), and a second chamber (Fig. 13, inflatable chamber 326’), and a tube assembly connected to the chambers (Fig. 13, par. 0112, “The conduits 332, 332', 332'' are connected in fluid communication with the inflatable chambers”). Malhi then teaches a tube assembly (Fig. 13, tube assembly comprises of conduit 332, 332’, connector 334, controller 312) with a three-way junction connector defining an inlet (connector 334, an inlet is defined coupled to controller 312). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known device of Bushara, with the tube assembly of Malhi, to have the bladders in fluid communication with a controller to inflate the chambers independently to provide therapy as taught by Malhi (Malhi, par. 0119).
The modified Bushara further discloses wherein the first bladder is in fluid communication with the second bladder via the tube assembly (See Fig. A; Bushara, par. 0051, “The trigger chamber 26D can be fluidly coupled to a connecting line 28D that is fluidly coupled to a stimulation chamber 30D”), the force actuation system configured to displace a fluid (Bushara, par. 0003, “The closed fluid system can be filled with air, a gas…”) from the first bladder to the second bladder in response to displacement of the first bladder (Bushara, par. 0051, “When pressure from the foot 70 is applied to trigger chamber 26D, portions of the stimulation chamber 30D will expand and contact the leg 70”).
Regarding Claim 2, the modified Bushara discloses the device of claim 1, wherein the second bladder is configured to contact a person during use of the device (Bushara Fig. 2, par. 0051, “The stimulation chamber 30D can be located on a portion of the leg 60”).
Regarding Claim 3, the modified Bushara discloses the device of claim 2, wherein the tube assembly comprises a first tube (Malhi, Fig. 13, conduit 332), a connector (Malhi, Fig. 13, common connector 334), and a second tube (Malhi, Fig. 13, conduit 332’), the first tube and the second tube being fluidly coupled via the connector (Malhi, par. 0112- 0114, the first and second tube are fluidly coupled to the connector, and the connector comprises a source of fluid, therefore the first and second tube are fluidly coupled via the connector) such that wherein the first tube is disposed between a first port of the connector (Malhi, Fig. 13, where element 332 connects to 334) and the first bladder (Malhi, Fig 13, par. 0112), and wherein the second tube is disposed between the second bladder and a second port of the connector (Malhi, Fig. 13, where element 332’ connects to 334; par. 0112).
Regarding Claim 4, the modified Bushara discloses the device of claim 3, wherein the inlet is a third port of the connector (Malhi, Fig. 13, where element 334 connects to 312), wherein the third port configured to adjust a bias pressure (Malhi, par. 0119, “The controller 312 may inflate the chambers 326, 326', 326'' to different pressures…”), and is configured to selectively receive a third tube (Malhi, Fig. 18, par. 0114, ports 350, 350’, 350’’; the controller 312 selectively deliver fluid through one of the ports to each inflatable bladder, which is then received by the connector), the third tube having a one way valve for loading the fluid into the device (Malhi, Fig. 18, valves 346A and 346B) (Examiner Notes: See Malhi par. 0114-0115; each tube 350 has valves 346 as an inflation valve to load fluid from the pressurizer to each bladder, see Fig. 18. An inflation valve under common definition is an one way valve as it only permits for inflation. Malhi further discloses an exhaust valve 348 for venting gas, further proving that the inflation valves are one way valves).
Regarding Claim 5, the modified Bushara discloses the device of claim 2, wherein the second bladder is configured to create a pressure on a nerve of a leg (Bushara, par. 0051, “portions of the stimulation chamber 30D will expand and contact the leg 70”; The prior art has the claimed structure; therefore, it is capable of create a pressure on a nerve of a leg).
Regarding Claim 6, the modified Bushara discloses the device of claim 1, wherein the first bladder is configured for passive actuation during use of the device (Examiner Notes: See Bushara, par. 0051, the device of prior art passively redistribute a force in response to a foot creating pressure on the device, this is the same actuation mechanism of the claimed invention).
Regarding Claim 8, the modified Bushara discloses the device of claim 1, further comprising an attachment mechanism (Bushara, Fig. 2, strap 40), wherein the attachment mechanism comprises the second bladder (Bushara, par. 0051, “stimulation chamber 30D can be coupled to the leg 60 by a strap 40”).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bushara in view of Malhi, further in view of Steinlauf et al. (US20160206500), hereafter Steinlauf.
Regarding Claim 7, Bushara discloses the device of claim 1, but is silent on further comprising a force indication system comprising a plurality of force sensors, each force sensor disposed in the insole assembly.
However, Steinlauf teaches a compression system (Fig. 6, compression system 100), comprising a plurality of inflatable bladders (Fig. 6, flexible bladders 310, 312), and a force indication system (par. 0063, “a processor 602 communicatively coupled (wired or wirelessly) to the pressure sensors 600a-n”) comprising a plurality of force sensors (Fig. 6, pressure sensors 600 a-n) (Examiner Notes: in the case of a compression device, the pressure and the force values are directly related and serves the same function), each force sensor is coupled to the corresponding bladder (par. 0061). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Bushara, with the force indication system of Steinlauf, and have force sensors coupled to the bladders wherein each force sensor disposed in the insole assembly, to increase user’s comfort and safety of the system as taught by Steinlauf (Steinlauf, par. 0065).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bushara in view of Malhi, further in view of Parish et al. (US10507131), hereafter Parish.
Regarding Claim 9, the modified Bushara discloses the device of claim 8, wherein the force actuation system further comprises a third bladder (Bushara, Fig. 2, trigger chamber 26E) and a fourth bladder (Fig. 2, stimulation chamber 30E), the third bladder in fluid communication with the fourth bladder (par. 0051, “The trigger chamber 26E can be fluidly coupled to a connecting line 28E that is fluidly coupled to a stimulation chamber 30E”), the insole assembly comprising the third bladder (See Fig. 2, chamber 26E is at the insole assembly)
The modified Bushara is silent on the attachment mechanism comprising the fourth bladder,
However, Parish teaches a compression device (Fig. 8), comprising of an attachment mechanism mounted on a user’s leg (Fig. 18A, calf wrap 1802), wherein the attachment mechanism comprising a first and second inflatable bladder (Fig. 18A, chambers 1804, 1808). Furthermore, Bushara further discloses the chambers can be located at anywhere as needed, including a leg area (Bushara, par. 0021, 0040). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Bushara, with the attachment mechanism of Parish, and have the attachment mechanism comprising the fourth bladder, in addition to the second bladder of Bushara, to facilitate and provide compression therapy to the user’s calf as taught by Parish (Parish, col. 9, line 16-38).
The modified Bushara further discloses the third bladder disposed proximate a toe of the user when in use (Bushara, Fig. 2, third chamber 26E is proximate to a toe)
The modified Bushara does not specifically disclose the first bladder disposed proximate a heel of a user when in use.
However, Bushara further discloses the trigger chamber can be located in one of a heel area, a toe area, and a side area (Bushara, par. 0021). Therefore, it would have been obvious to try, by one of ordinary skilled in the art, to place the first bladder proximate to a heel of a user when in use, since Bushara discloses a finite number of identified, predictable potential solutions to the placement of the first bladder, and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success.
Claim(s) 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bushara in view of Parish.
Regarding Claim 10, Bushara discloses a force actuation system (See Fig. A) for a device (Fig. 2, a device 20B), comprising: a first bladder (Fig. 2, trigger chamber 26D; See Fig. A) configured to be disposed proximate a foot of a user when in use (See Fig. 2, element 26D is contacting the foot); and an attachment mechanism (Fig. 2, strap 40) comprising a second bladder (Fig. 2, stimulation chamber 30D; See Fig. A) in fluid communication with the first bladder (par. 0051, “The trigger chamber 26D can be fluidly coupled to a connecting line 28D that is fluidly coupled to a stimulation chamber 30D”), the force actuation system configured to displace a first fluid (par. 0003, “The closed fluid system can be filled with air, a gas…”) from the first bladder to the second bladder in response to pressure being applied of the first bladder, and configured to receive the first fluid from the second bladder to the first bladder in response to pressure being released from the first bladder (par. 0051, “When pressure from the foot 70 is applied to trigger chamber 26D, portions of the stimulation chamber 30D will expand and contact the leg 70”).
Bushara is silent on the attachment mechanism defining a cuff, the cuff comprising a second bladder in fluid communication with the first bladder.
However, Parish teaches a compression device (Fig. 8), comprising of an attachment mechanism defining a cuff (Fig. 18A, calf wrap 1802), wherein the cuff comprising a first and second inflatable bladder (Fig. 18A, chambers 1804, 1808). Furthermore, Bushara further discloses the chambers can be located at anywhere as needed, including a leg area (Bushara, par. 0021, 0040). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Bushara, with the attachment mechanism of Parish, and have the cuff comprising a second bladder, to facilitate and provide compression therapy to the user’s calf as taught by Parish (Parish, col. 9, line 16-38).
The modified Bushara is still silent on the second bladder is in fluid communication with the first bladder via a three-way junction connector defining an inlet
However, Malhi teaches a compression device (Fig. 13, compression system 310), comprising of a first bladder (Fig. 13, inflatable chamber 326), and a second chamber (Fig. 13, inflatable chamber 326’), and a tube assembly connected to the chambers (Fig. 13, par. 0112, “The conduits 332, 332', 332'' are connected in fluid communication with the inflatable chambers”). Malhi then teaches a tube assembly (Fig. 13, tube assembly comprises of conduit 332, 332’, connector 334, controller 312) with a three-way junction connector defining an inlet (connector 334, an inlet is defined coupled to controller 312). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known device of Bushara, with the connecter of Malhi, to have the bladders in fluid communication with a controller to inflate the chambers independently to provide therapy as taught by Malhi (Malhi, par. 0119).
Regarding Claim 11, the modified Bushara discloses the force actuation system of claim 10, further comprising: a third bladder (Bushara, Fig. 2, trigger chamber 26E) configured to be disposed proximate a toe of the user when in use (Bushara, par. 0051, “Trigger chamber 26E can be located near the toe area ”)
The modified Bushara does not specifically disclose the first bladder is configured to be disposed proximate a heel of the user when in use.
However, Bushara further discloses the trigger chamber can be located in one of a heel area, a toe area, and a side area (Bushara, par. 0021). Therefore, it would have been obvious to try, by one of ordinary skilled in the art, to place the first bladder proximate to a heel of a user when in use, since Bushara discloses a finite number of identified, predictable potential solutions to the placement of the first bladder, and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success.
The modified Bushara further discloses a fourth bladder (Bushara, Fig. 2, stimulation chamber 30E) in fluid communication with the third bladder (Bushara, par. 0051, “The trigger chamber 26E can be fluidly coupled to a connecting line 28E that is fluidly coupled to a stimulation chamber 30E”).
The modified Bushara is silent on the cuff comprising the fourth bladder such that the third bladder and the fourth bladder is disposed on an opposite side of the cuff with respect to eh third bladder.
However, Parish further teaches the cuff (Fig. 18A, calf wrap 1802) a first and second inflatable bladder (Fig. 18A, chambers 1804, 1808), disposed on an opposite side of the cuff. Furthermore, Bushara further discloses the chambers can be located at anywhere as needed, including a leg area (Bushara, par. 0021, 0040). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Bushara, with the attachment mechanism of Parish, and have the cuff comprising the fourth bladder such that the third bladder and the fourth bladder is disposed on an opposite side of the cuff with respect to the third bladder, to facilitate and provide compression therapy to the user’s calf as taught by Parish (Parish, col. 9, line 16-38).
The modified Bushara further discloses the force actuation system configured to displace a second fluid (par. 0003, “The closed fluid system can be filled with air, a gas…”) (Examiner Notes: The third and fourth bladders are fluidly independent from the first and second bladders, therefore they are each filled with individual fluids) from the third bladder to the fourth bladder in response to displacement of the third bladder (par. 0051, “When pressure from the foot 70 is applied to trigger chamber 26E, portions of the stimulation chamber 30E will expand”).
Regarding Claim 12, the modified Bushara discloses the force actuation system of claim 10, wherein the attachment mechanism is configured to couple to a leg of the user (Bushara, Fig. 2, par. 0051, “…be coupled to the leg 60 by a strap 40”).
Regarding Claim 13, the modified Bushara discloses the force actuation system of claim 10, further comprising an insole assembly comprising the first bladder (See Fig. A).
Regarding Claim 14, the modified Bushara discloses the force actuation system of claim 10, further comprising a piece of footwear (Bushara, Fig. 2, footwear 62A), wherein the first bladder is disposed in the piece of footwear (See Bushara, Fig. 2, par.0051, “A trigger chamber 26D can be located near a side of the footwear 62A”).
Regarding Claim 15, the modified Bushara discloses the force actuation system of claim 10, wherein the force actuation system is a passive force actuation system (Examiner Notes: See Bushara, par. 0051, the device of prior art passively redistribute a force in response to a foot creating pressure on the device, this is the same actuation mechanism of the claimed invention).
Regarding Claim 16, the modified Bushara discloses the force actuation system of claim 10, wherein the second bladder is configured to be disposed proximate a nerve of the user when in use (Examiner Notes: See Bushara, par. 0051, the second bladder of the prior art has the claimed structure and is in contact with the leg, sensory nerves are inherently distributed throughout the leg).
Claim(s) 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bushara in view of Malhi, in view of Steinlauf, further in view of Brosnan (US20170172838).
Regarding Claim 18, the modified Bushara discloses The device of claim 1, but is silent on further comprising a force indication control system having a first force sensor disposed in an insole; a second force sensor disposed in the insole; a transmitter in electrical communication with the first force sensor and the second force sensor; a receiver; a controller in electrical communication with the receiver; and a tangible, non-transitory memory configured to communicate with the controller, the tangible, non-transitory memory having instructions stored thereon that, in response to execution by the controller, cause the controller to perform operations comprising: receiving, by the controller and through the receiver, a first force measurement from the first force sensor, and commanding, by the controller, illumination of a light based on the first force measurement from the first force sensor.
However, Steinlauf teaches a compression system (Fig. 6, compression system 100), comprising a plurality of inflatable bladders (Fig. 6, flexible bladders 310, 312), and a force indication system (par. 0063, “a processor 602 communicatively coupled (wired or wirelessly) to the pressure sensors 600a-n”) having a first force sensor; a second force sensor (Fig. 6, pressure sensors 600a and 600b) (Examiner Notes: in the case of a compression device, the pressure and the force values are directly related and serves the same function), each force sensor is coupled to the corresponding bladder (par. 0061). A transmitter in electrical communication with the first force sensor and the second force sensor (par. 0022, “a transmitter coupled to the at least one pressure sensor”); a receiver (par. 0063, “The processor 602 may be operably configured to receive data produced by the pressure sensors 600a-n through a transmitter 604. The transmitter 604 may be a wireless transmitter/receiver”) a controller in electrical communication with the receiver (par. 0063, processor 602, Fig. 6); and a tangible, non-transitory memory configured to communicate with the controller (par. 0064, “a memory having a database coupled to the processor 602). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Bushara, with the force indication system of Steinlauf, and have force sensors coupled to the bladders wherein the first and second force sensor are coupled to each bladder disposed in the insole assembly, to use the data measured by the sensor to assist healthcare providers as taught by Steinlauf (Steinlauf, par. 0065).
The modified Bushara is still silent on the tangible, non-transitory memory having instructions stored thereon that, in response to execution by the controller, cause the controller to perform operations comprising: receiving, by the controller and through the receiver, a first force measurement from the first force sensor, and commanding, by the controller, illumination of a light based on the first force measurement from the first force sensor.
However, Brosnan teaches a compression device (Fig. 3, patient therapy device 100), comprising of a force sensor (par.0065, pressure sensor 222), a controller (Fig. 3, controller 102), a memory (par. 0036), where the memory having instructions stored thereon that, in response to execution by the controller, cause the controller to perform operations (par. 0036, “an algorithm stored in memory to control operation of the patient therapy device 100”) comprising: receiving, by the controller and through the receiver, a first force measurement from the first force sensor (par. 0065, “The pressure sensor 222 is configured to provide a pressure input signal to the controller 102”), and commanding, by the controller, illumination of a light based on the first force measurement from the first force sensor (par. 0109, “the controller 102 may send an output signal to the alarm system 114 that triggers an illumination of one or more LED lights”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Bushara, with the memory and the light of Brosnan, to provide alarm for the user and caregiver as taught by Brosnan (Brosnan, par. 0109).
Regarding Clam 19, the modified Bushara discloses the device of claim 18, further comprising: wherein the insole assembly comprises the first force sensor, the second force sensor, and the transmitter (Examiner Notes: Steinlauf teaches each sensor is coupled to corresponding bladder, and the transmitter is coupled to the pressure sensor, see par. 0022, 0061; therefore, after the modification, the sensor and transmitter would in the insole assembly); and further comprising a wearable device comprising the receiver and the controller (Fig. 5, device storage unit 504; par. 0058, “the device storage unit 504 is disposed on an anterior portion of the outer shell 104 proximal to the location of the user's shin”; par. 0063, “the processor 602 is coupled to the device storage unit 504… The processor 602 may be operably configured to receive data produced by the pressure sensors”).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bushara in view of Malhi, further in view of Edelman et al. (US9114055), hereafter Edelman.
Regarding Claim 25, the modified Bushara discloses the device of claim 3, but is silent on wherein the third port is configured to be selectively sealed in response to removal of the third tube.
However, Edelman teaches a pressure therapy device (Fig. 7B), comprising of a first and second bladder (Fig. 7A, 7B, chambers 110 and 120), and a connector (Fig. 7A, 130). Edelman then teaches that the connector comprises of a first tube disposed between a first port and the first bladder (Fig. 7A, branch 122, a tube extended to bladder 110), a second tube disposed between a second port and the second bladder (Fig. 7A, branch 124, a tube extended to bladder 120), and a third port connected to a third tube (Fig. 7A, port connected to tube 22). Edelman further teaches a seal (Fig. 7A, seal 114) around the connector, allowing the third port is configured to be selectively sealed in response to removal of the third tube (col. 12, line 1-18). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Bushara, with the sealing structure of Edelman, for sealing the bladders after filling the fluid as taught by Edelman (Edelman, col. 12, line 1-18).
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive. Specifically, regarding Claim 1 and 10, the applicant argues the proposed modification changes the principle of operation of a reference. However, the office action does not rely on Malhi to replace Bushara’s gait-synchronized actuation. Rather, Malhi is relied upon solely for teaching a tube assembly including a three-way junction defining an inlet. Incorporating this known fluid routing structure into Bushara would not eliminate Bushara’s pressure-based actuation, but would merely provide a structural arrangement for filling each chamber with fluids since the bladders in Bushara is already in fluid communication via element 28, see Fig. 1, 2.
Applicant then argues that Malhi does not disclose fluid communication between the chambers. However, the claim broadly recite fluid communication between the bladders via a tube assembly, the claim does not require any bidirectional valve or specific valve structure permitting simultaneous two-way flow. Malhi discloses conduits, connector, and valves for fluid control. The presence of inflation and exhaust valves does not negate fluid communication, even in systems using check valves, fluid may be displaced from one chamber to another through controlled paths. For example, the system of Bushara could still operate as intended with, with the valves of Malhi closed and fluid source shut off, thereby preserving Bushara’s closed, pressure-responsive operation through the existed connecting lines of 28. Such modification merely provides an alternative structural arrangement for fluid control and is within the skill of an ordinary person in the art. The proposed combination employs a known connector assembly to inflatable chambers that are in fluid communication, and does not render Bushara inoperable.
Regarding Claim 4, the claim recites “selectively receive a third tube”. The claim is broad and does not require a detachable coupling. A port that is structured to receive a tube for selected fluid delivery is inherently capable of selectively being received by a port. Furthermore, making a component removable is an obvious matter of design choice, see In re Larson, unless there are unexpected results.
Regarding Claim 15, the applicant argues that the proposed modification would change the principle of operation of the prior art. However, the modification purely relies on Malhi for the tube assembly and fluid filling purposes. Incorporating Malhi does not require converting Bushara’s system into an active system. Bushara’s device can continue operate passively, for example through the preexisted connecting lines 28 when the fluid source is off. Therefore, the arguments are not persuasive.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785