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 amendments filed 11/6/2025 have been entered. Accordingly, claims 1, 14, 17-18, 25, 29, 42-45, 49-50, and 52-57 remain pending in the current application.
Response to Arguments
Regarding independent claims 1 and 14, applicant argues on pages 7-8 of the remarks filed 11/6/2025 that there is no evidence in Grove that suggests Grove’s device as being capable of inflating the bellows within 0.25 to about 0.5 seconds to achieve 20-45 degrees of dorsiflexion, as required by the claim, stating that Grove’s inflation period is regulated by a valve controller and thus is limited by the capacity of the air pump. The Examiner respectfully disagrees, with Col. 6 line 27 of Grove clearly stating the inflatable periods being in time intervals of less than 1 second, therefore within the claimed time range, and Col. 11 lines 30-39 clearly stating the footplate is displaced between 1 and 30 degrees dorsiflexion, therefore fully capable of achieving an angle of dorsiflexion in the claimed range. Furthermore, the Examiner notes that page 6 of the office action dated 8/6/2025 states that should there be any doubt that Grove explicitly teaches inflation time intervals ranging from 0.25 to 0.5 seconds, Fox teaches a method of treating DVT wherein the inflation occurs in time intervals in the range of 0.5 seconds or less.
Applicant’s arguments with respect to claims 1 and 14 regarding the compressed air tank limitation(s) 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. The Examiner notes the new prior art reference(s) now relied upon in the current office action.
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.
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.
Claim(s) 14, 17-18, 25, 29, 42-45, and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Grove et al. (6,010,468) in view of Lamont (5,453,082) and in further view of Arkans et al. (US 2016/0175184 A1), and alternatively further in view of Fox (US 5,669,872 A).
Regarding claim 14, Grove discloses a device configured to active calf muscle contractions and configured to induce calf muscular activity in a patient (foot flexion device, Figure 1; the device dorsiflexes the patient’s foot such that the calf muscle is exercised, Col. 1 lines 14-20; the Examiner notes that as Grove’s device flexes the user’s foot, the device is fully capable of activating calf muscle contractions and inducing calf muscular activity to some degree), the device comprising: i) a substantially rigid frame (boot 20 made of a moldable plastic which is rigid in its final shape, Figure 1 and Col. 10 lines 15-17), ii) a foot support assembly (foot support assembly comprising rigid base plate 22 and footplate 61, Figure 1) comprising a dorsiflexion inducing member comprising an inflatable bladder configured and dimensioned to move the foot away from the frame when the foot support assembly is worn by the patient and the bladder is inflated (foot support assembly comprising footplate 61 that is raised by an inflatable bellows 133, to therefore impart flexion of the foot, when bellows 133 is inflated the foot is thereby moved away from the bottom base plate 22 of the frame 20, Figure 1 and Col. 11 lines 41-45), iii) an ankle support component (strap 19 securing ankle to boot 20, Figure 1), and wherein periodic bursts inflate the bladder and urges the patient’s foot into 20-45 degrees of dorsiflexion (inflatable bellows 133 is coupled to a controller 1 comprising a pump 161 to thereby inflate the bellows 133, Figure 1 and Col. 12 lines 46-55; when inflated, bellows 133 pivotally displaces footplate 61 preferable between 1 and 30 degrees dorsiflexion, therefore within the claimed range, Figure 3 and Col. 11 lines 30-39) with time intervals ranging from about 0.25 seconds to about 0.5 seconds, thereby activating calf muscle contraction and inducing the calf muscular activity (pulse frequency of the inflatable bellows is adjustable, and may be pre-selected time intervals in the range of 1-20 cycles/minute resulting in rapid inflation and deflation in less than 1 second, Col. 6 lines 25-27; inflation period is typically 0.5 to 5 seconds, although a faster or slower rate may be achieved by adjustment of the controls, Col. 8 lines 40-41; the Examiner notes that as Grove’s device flexes the user’s foot, the device is fully capable of activating calf muscle contractions and inducing calf muscular activity).
However, Grove is silent on the rigid frame being substantially covered in fabric and/or padding, and although Grove teaches a main control sub-system comprising an air pump, a 3-way valve, a valve controller, a fluid bellows for air or liquids, and a pulse generator (Col. 7 lines 36-38), Grove doesn’t explicitly state a head unit comprising an air compressor adapted to fill a compressed air tank to a tank pressure of about 20 psi to about 25 psi, and coupled to the inflatable bladder and configured to release compressed air to the inflatable bladder upon the opening of a solenoid valve, wherein the opening and closing of the solenoid valve releases bursts of air having a duration of 200 milliseconds to about milliseconds.
Regarding the frame being covered in fabric or padding, Lamont teaches a medical boot comprising a pneumatically operated bladder disposed between the foot portion and the patient’s foot to impart various degrees of flexion (Abstract and medical boot 10 comprising inflatable bladder 86, Figure 1), wherein the boot comprising a rigid frame (splint comprises a rigid sole 37 and rigid leg splint 48, Claim 1 and Figures 5-6) wherein the rigid frame is substantially covered in fabric and/or padding (both the upper portion of the boot and the sole are covered with a soft, flexible cloth material, Col. 2 lines 40-45).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Grove’s device by including fabric and/or padding to cover the rigid frame, as taught by Lamont, as providing such a fabric or padded material may provide enhanced comfort to the user by providing a barrier between the rigid frame and the patient’s leg and/or foot.
Regarding a head unit comprising an air compressor adapted to fill a compressed air tank to a tank pressure of about 20 psi to about 25 psi, and coupled to the inflatable bladder and configured to release compressed air to the inflatable bladder upon the opening of a solenoid valve, wherein the opening and closing of the solenoid valve releases bursts of air having a duration of 200 milliseconds to about 300 milliseconds, Arkans teaches a system configured to impart high-frequency pulse waveforms to one or more inflatable cuffs on a lower limb of a user (Abstract and Figure 1) wherein the system further teaches a head unit comprising an air compressor adapted to fill a compressed air tank to a tank pressure of about 20 psi to 25 psi (pump 102 can include a pressure tank and compressor for pressurizing a pressure tank, with the tank being pressurized to 20 psi under normal operating conditions, Paragraph 0016 and Figure 1) such that the pressurized tank is coupled to the inflatable bladders and configured to release the compressed air to the inflatable bladders upon opening of a solenoid valve (an inflation valve is configured to apply pressurized air to the cuff bladder upon opening of the inflation valve, inflation valve is connected to the pressurized tank, Paragraph 0016; a 2-way fast acting solenoid valve may be used as the inflation valve, Paragraph 0015), wherein the opening and closing of the solenoid valve releases bursts of air having a duration of 200 milliseconds to about milliseconds (the opening/closing of the solenoid inflation valve allows for pulsed inflation under 400 ms, and even under 250 ms, therefore within the claimed range, Paragraph 0015).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Grove’s device by replacing the air pump with a compressed air tank coupled to the inflatable bladder, wherein the release of the compressed air into the bladders is controlled by a solenoid valve, as taught by Arkans, as providing a compressed air tank provides a more automated control system, allows for storage of compressed air, and provides a means of precisely controlling the pulsed to the inflatable bladder.
Additionally, should there be any doubt Grove explicitly teaches time intervals ranging from about 0.25 to 0.5 seconds, Fox teaches a method of treating a diagnosed or potential deep-vein thrombosis of a user’s leg (Abstract) in which the user’s foot is placed inside a foot holster (padded wrap 16, Figure 1) comprising an actuator configured to rapidly flex the foot dorsally into a compression holder (inflatable foot bag 14 applies upward force to the user’s ball of the foot while also reacting against the circumferentially tied wrap 16, Col. 3 lines 48-56) wherein the flexion occurs in time intervals ranging from about 0.25 second to 0.5 seconds (inflation of foot bag 14 is desirably rapid and preferably in the range of 0.5 seconds or less, therefore within the claimed time interval range, Col. 4 lines 60-63).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to further modify Grove’s foot flexion device by having the dorsiflexion of the foot occur in rapid time intervals ranging from about 0.25 seconds to 0.5 seconds, as taught by Fox, as such rapid motion applied to the sole of the foot aids in the stimulation of venous blood flow and simulates a walking rate of a user (Col. 3 lines 48-56 of Fox) which increases the rate of therapeutic effect on the thrombosis, which is desired by the device of Grove (Col. 1 lines 5-8 of Grove).
Regarding claim 17, Grove in view of Lamont, Arkans and Fox teach the device of claim 14, with Grove further disclosing wherein the foot support assembly is configured to place the foot in a rest position (when input of fluid to the inflatable bellows is stopped and footplate is not in motion, the bellows are deflated and foot plate returns to a neutral position, Col. 7 lines 21-27 and Figure 4), wherein the dorsiflexion inducing member (inflatable bellows 133, Figure 1) is engaged with a ball of the foot while the foot is in plantarflexion (the user’s foot is secured to the footplate 61 and padded surface 23 by a strap 16 and over the ball of the user’s foot, therefore positioning the inflatable bellows 133 aligned with the ball of the user’s foot during both dorsiflexion and plantarflexion, Figure 3 and Col. 11 lines 16-21), and a dorsiflexed position wherein the dorsiflexion inducing member applies pressure to the ball of the foot in a dorsiflexed position (the user’s foot is secured to the footplate 61 and padded surface 23 by a strap 16 and over the ball of the user’s foot, therefore positioning the inflatable bellows 133 aligned with the ball of the user’s foot during both dorsiflexion and plantarflexion, Figure 3 and Col. 11 lines 16-21).
Regarding claim 18, Grove in view of Lamont, Arkans and Fox teach the device of claim 14, with Grove further disclosing a controller coupled to the foot support assembly, (controller 1 connected to boot 20 via tubing 13 suitable for rapidly transmitting air or other fluids at pressures at least up to 20 psi, Figure 1 and Col. 9 lines 53-55), configured to induce the periodic dorsiflexion in a predetermined time cycle (the controller is adjustable to inflate and deflate the bellows 133 at a predetermined frequency such as 0.1-20.0 cycles/min, Col. 4 lines 43-45), wherein the predetermined time cycle includes a plurality of dorsiflexion time periods (the intermittent pumping of fluid at pre-selected intervals results in the rapid inflation and deflation of the bellows resulting in dorsiflexion and relaxation of the foot, Col. 6 lines 25-30), wherein each dorsiflexion time period is followed by a rest time period (the intermittent pumping of fluid at pre-selected intervals results in the rapid inflation and deflation of the bellows resulting in dorsiflexion and relaxation of the foot, Col. 6 lines 25-30, deflation periods being the rest periods), wherein each of the dorsiflexion time periods being of substantially uniform duration (each inflation/dorsiflexion period is less than 1 second in duration, Col. 6 lines 25-30).
Regarding claim 25, Grove in view of Lamont, Arkans and Fox teach the device of claim 14, with Grove further disclosing wherein the foot support assembly is configured to position the patient's foot at about 5 degrees to about 10 degrees of plantar flexion in an at-rest position (in the neutral position, the base plate 22 and the calf member plate 51 meet at an angle of approximately 110 degrees, therefore resulting in an angle of about 5 to 10 degrees of plantarflexion, Figure 3 and Col. 6 lines 17-22), and induce periodic dorsiflexion in a fully flexed position of about 35 degrees to about 55 degrees relative to the at-rest position (when inflated, bellows 130 pivotably displaces footplate 61 30 degrees upward relative to baseplate 22, Col. 11 lines 30-32; the Examiner notes that 30 degrees of flexion would fall within the acceptable error range described in applicant’s specification on Page 44, which states the term “about” means within an acceptable error range such as within 3 standard deviations of a given range, or up to 15%, 10%, 5%, or 1% of a given value).
Regarding claim 29, Grove in view of Lamont, Arkans and Fox teach the device of claim 14, with Grove further disclosing wherein the foot support assembly is configured to produce a reverse flow velocity index in a venous valve sinus of the patient during the periodic dorsiflexion (foot flexion device capable of enhancing blood and lymph flow in the lower extremities, therefore the device is fully capable of producing reverse flow velocity index in a venous valve of the patient during dorsiflexion, Col. 3 lines 29-33).
Regarding claim 42, Grove in view of Lamont, Arkans and Fox teach the device of claim 14, with Grove further disclosing wherein the inflatable bladder comprises a foot engaging surface (inflatable bellows 133 coupled to the footplate 61 comprising a padded surface 23 to engage the user’s foot, Figure 3) that is configured and dimensioned to engage a ball of the patient's foot when the foot support assembly is worn by the patient (the user’s foot is secured to the footplate 61 and padded surface 23 by a strap 16 and over the ball of the user’s foot, Figure 3 and Col. 11 lines 16-21), wherein at a peak inflation point the bladder terminates at a position that is distal of a heel pad of the foot (when inflatable bellows 133 is fully inflated, the bellows 133 terminates at a position that is distal a heel pad of the user’s foot, as best shown in Figure 1).
Regarding claim 43, Grove further discloses wherein the inflatable bladder is further configured to induce a bottom of the patient's foot to form a maximum angle with respect to the frame of about 30 degrees to about 45 degrees when the inflatable bladder is fully inflated (when inflated, bellows 130 pivotably displaces footplate 61 30 degrees upward relative to baseplate 22, Col. 11 lines 30-32; the Examiner notes that 30 degrees of flexion would fall within the acceptable error range described in applicant’s specification on Page 44, which states the term “about” means within an acceptable error range such as within 3 standard deviations of a given range, or up to 15%, 10%, 5%, or 1% of a given value).
Regarding claim 44, Grove further teaches wherein the inflatable bladder is further configured to induce dorsiflexion of the patient's foot of about 30 degrees to about 45 degrees relative to a neutral position of the foot (when inflated, bellows 130 pivotably displaces footplate 61 30 degrees upward relative to baseplate 22, Col. 11 lines 30-32; the Examiner notes that 30 degrees of flexion would fall within the acceptable error range described in applicant’s specification on Page 44, which states the term “about” means within an acceptable error range such as within 3 standard deviations of a given range, or up to 15%, 10%, 5%, or 1% of a given value) where the foot is at an angle of approximately 90 degrees relative to the patient's tibia (calf member plate 51 joins base plate 22 at an angle between 90 and 125 degrees, therefore the user’s foot is at an angle of approximately 90 degrees relative to the patient’s tibia, Col. 11 lines 1-4; the Examiner notes that an angle of 90 degrees would fall within the acceptable error range described in applicant’s specification on Page 44, in which states the term “about” means within an acceptable error range such as within 3 standard deviations of a given range, or up to 15%, 10%, 5%, or 1% of a given value).
Regarding claim 45, Grove further discloses wherein the inflatable bladder (inflatable bellows 133, Figure 1) is further configured to retain a minimum positive pressure throughout the predetermined time cycle (when device is actuated, air is delivered to the inflatable bellows 133 for a sufficient amount of time, at a sufficient pressure, to thereby inflate and maintain the bellows to the extent desired, Col. 8 lines 35-40).
Regarding claim 49, Grove in view of Lamont, Arkans and Fox teach the device of claim 14, with Grove further disclosing high ankle securement configured to secure the frame to the patient's leg at a high ankle of the patient at between about 3 inches and about 7 inches above a bottom of the patient's foot (calf member 51, to which high ankle strap 18 is secured to, extends approximately 5-6 inches above the ankle to approximately 12 inches above the ankle, depending on the size and needs of the user, Col. 11 lines 5-6 and Figure 1).
Regarding claim 50, Grove in view of Lamont, Arkans and Fox teach the device of claim 14, with Grove further disclosing wherein the inflation bladder is positioned to make contact with the ball of the subject's foot to drive dorsiflexion (the user’s foot is secured to the footplate 61 and padded surface 23 by a strap 16 and over the ball of the user’s foot, therefore positioning the inflatable bellows 133 aligned with the ball of the user’s foot, Figure 3 and Col. 11 lines 16-21), which creates tightening of the calf muscle (the dorsiflexion imparted by the inflatable bellows 133 fully capable of tightening the calf muscle of the user, Figure 1).
Claim(s) 1, 52-54, and 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Grove et al. (6,010,468) in view of Arkans et al. (US 2016/0175184 A1), and alternatively further in view of Fox (US 5,669,872 A).
Regarding claim 1, Grove discloses a medical device configured to activate calf muscle contractions and configured to induce calf muscular activity in an immobile person (foot flexion device, Figure 1; the device dorsiflexes the patient’s foot such that the calf muscle is exercised, Col. 1 lines 14-20; the Examiner notes that as Grove’s device flexes the user’s foot, the device is fully capable of activating calf muscle contractions and inducing calf muscular activity to some degree), comprising: an inflatable bladder (inflatable bellows 133; foot support assembly comprising footplate 61 that is raised by an inflatable bellows 133, to therefore impart flexion of the foot, Figure 1 and Col. 11 lines 41-45), disposed within a wearable boot (see inflatable bellows 133 disposed within a wearable boot 20, Figure 1), wherein an actuator causes the opening of the solenoid valve causes the bladder to be inflated and to cause 20-45 degrees of dorsal flexion of the foot (inflatable bellows 133 is coupled to a controller 1 comprising a pump 161 to thereby inflate the bellows 133, Figure 1 and Col. 12 lines 46-55; when inflated, bellows 133 pivotally displaces footplate 61 preferable between 1 and 30 degrees dorsiflexion, therefore within the claimed range, Figure 3 and Col. 11 lines 30-39) in time intervals ranging from about 0.25 seconds to 0.5 seconds (pulse frequency of the inflatable bellows is adjustable, and may be pre-selected time intervals in the range of 1-20 cycles/minute resulting in rapid inflation and deflation in less than 1 second, Col. 6 lines 25-27; inflation period is typically 0.5 to 5 seconds, although a faster or slower rate may be achieved by adjustment of the controls, Col. 8 lines 40-41), and wherein the rapid flexion induced by the device generates calf muscle contractions reflex thereby inducing calf muscular activity in the immobile person (the rapid flexion induced by the inflatable bellows 133 fully capable of generating calf muscle contraction reflex in an immobile person, as the bellows 133 urges the user’s foot into dorsiflexion repetitively, Figures 1-3; the Examiner notes that as Grove’s device flexes the user’s foot, the device is fully capable of activating calf muscle contractions and inducing calf muscular activity to some degree).
However, although Grove teaches a main control sub-system comprising an air pump, a 3-way valve, a valve controller, a fluid bellows for air or liquids, and a pulse generator (Col. 7 lines 36-38), Grove doesn’t explicitly state the inflatable bladder being pneumatically coupled to a head unit that is adapted to drive inflation and deflation of the inflation bladder, the head unit comprises: i) an air compressor, coupled to a compressed air tank and adapted to fill the compressed air tank with compressed air to a predetermined pressure ii) a solenoid valve having a controllable opening, and iii) wherein the compressed air tank is further coupled to the solenoid valve to controllably release the compressed air to the inflatable bladder upon opening of the valve.
However, Arkans teaches a system configured to impart high-frequency pulse waveforms to one or more inflatable cuffs on a lower limb of a user (Abstract and Figure 1) wherein the system further teaches a head unit comprising an air compressor adapted to fill a compressed air tank to a tank pressure of about 20 psi to 25 psi (pump 102 can include a pressure tank and compressor for pressurizing a pressure tank, with the tank being pressurized to 20 psi under normal operating conditions, Paragraph 0016 and Figure 1) such that the pressurized tank is coupled to the inflatable bladders and configured to release the compressed air to the inflatable bladders upon opening of a solenoid valve (an inflation valve is configured to apply pressurized air to the cuff bladder upon opening of the inflation valve, inflation valve is connected to the pressurized tank, Paragraph 0016; a 2-way fast acting solenoid valve may be used as the inflation valve, Paragraph 0015), wherein the opening and closing of the solenoid valve releases bursts of air having a duration of 200 milliseconds to about milliseconds (the opening/closing of the solenoid inflation valve allows for pulsed inflation under 400 ms, and even under 250 ms, therefore within the claimed range, Paragraph 0015).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Grove’s device by replacing the air pump with a compressed air tank coupled to the inflatable bladder, wherein the release of the compressed air into the bladders is controlled by a solenoid valve, as taught by Arkans, as providing a compressed air tank provides a more automated control system, allows for storage of compressed air, and provides a means of precisely controlling the pulsed to the inflatable bladder.
Should there be any doubt Grove explicitly teaches time intervals ranging from about 0.25 to 0.5 seconds, Fox teaches a method of treating a diagnosed or potential deep-vein thrombosis of a user’s leg (Abstract) in which the user’s foot is placed inside a foot holster (padded wrap 16, Figure 1) comprising an actuator configured to rapidly flex the foot dorsally into a compression holder (inflatable foot bag 14 applies upward force to the user’s ball of the foot while also reacting against the circumferentially tied wrap 16, Col. 3 lines 48-56) wherein the flexion occurs in time intervals ranging from about 0.25 second to 0.5 seconds (inflation of foot bag 14 is desirably rapid and preferably in the range of 0.5 seconds or less, therefore within the claimed time interval range, Col. 4 lines 60-63).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to further modify Grove’s foot flexion device by having the dorsiflexion of the foot occur in rapid time intervals ranging from about 0.25 seconds to 0.5 seconds, as taught by Fox, as such rapid motion applied to the sole of the foot aids in the stimulation of venous blood flow and simulates a walking rate of a user (Col. 3 lines 48-56 of Fox) which increases the rate of therapeutic effect on the thrombosis, which is desired by the device of Grove (Col. 1 lines 5-8 of Grove).
Regarding claim 52, Grove in view of Arkans teach the device of claim 1, with Arkans further teaching wherein the head unit further comprises at least one pressure sensor, adapted to monitor air pressure of the compressed air tank and restore the air pressure to about 20 to about 25 psi (a pressure sensor may be used for determining cuff bladder and tank pressure, making adjustments as needed, such that the pressurized tank is maintained at 20 psi, Paragraphs 0014-0015).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to further modify Grove’s foot flexion device by including a pressure sensor to monitor the pressure of the tank, as taught further taught by Arkans, as providing a pressure sensor provides a means of monitoring the pressure throughout the system, and thus providing a more robust and automated means of controlling the output air towards the inflatable chamber.
Regarding claim 53, Grove in view of Arkans and Fox teach the device of claim 1, with Grove further teaching at least one pressure relief valve, adapted to monitor air pressure of the inflation bladder and prevent over- inflation thereof (inflatable bellows 133 may comprise a pressure release valve to prevent over-inflation, Col. 4 lines 56-59).
Regarding claim 54, Grove in view of Arkans and Fox teach the device of claim 1, with Arkans further teaching wherein the head unit further comprises a control board adapted to initiate inflation of the inflation bladder and to control parameters of inflation (the cuff bladders are inflated and deflated through the actuation of the solenoid valves according to desired sequences and pressured, determined by an electronic controller, Paragraph 0005).
Regarding claim 56, Grove in view of Arkans and Fox teach the device of claim 1, with Grove further teaching wherein the wearable boot comprises a rigid plastic frame (boot 20 made of a moldable plastic which is rigid in its final shape, Figure 1 and Col. 10 lines 15-17), configured to attach to a foot of the wearer and to extend to an ankle of the wearer (see boot 20 attached to foot of user and extending to an ankle of the wearer, Figure 1).
Regarding claim 57, Grove in view of Arkans and Fox teach the device of claim 1, with Grove further teaching wherein the inflation bladder is adapted to be deflated to 10 mmHg such that the inflation bladder can be re-inflated (the inflatable bellows 133 may be controlled such that it inflates and deflates at a frequency of 0.1-20cycles/minute, therefore fully capable of deflating to 10 mmHg such that the bladder may be re-inflated, Figure 1 and Col. 4 lines 43-45).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Grove et al. (6,010,468) in view of Arkans et al. (US 2016/0175184 A1), and in further view of Bock et al. (US 5,876,359).
Regarding claim 55, Grove in view of Arkans teach the device of claim 1, however are silent wherein the head unit further comprises an alarm system, adapted to detect a mechanical malfunction and to provide an audible alert in response to the mechanical malfunction.
However, Bock teaches a device configured to apply sequential compressive forces to a limb of a user (Abstract and Figure 1) comprising a head unit (housing 10 comprising control or front panel 12, Figure 1) wherein the head unit further comprises an alarm system adapted to detect a mechanical malfunction and to provide an audible alert in response to a mechanical malfunction (if detection that the system is experiencing an interruption in normal operation, an appropriate fault code will be displayed on front panel 12 with an audible alarm indicator 15, Col. 6 lines 25-30).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to further modify Grove’s device by including an alarm system adapted to detect mechanical malfunction of the system to produce an audible alarm in response to the detection, as taught by Bock, as providing such an alarm system would provide the user with a means of audibly indicating something is wrong with the system, improving the overall safety of the device.
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.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785