DETAILED ACTION
This office action is in response to the amendment filed 2/11/2026. As directed by the amendment, claims 1-2, 4 8-9, 11-14, 16, 18-20, and 23-24 have been amended, no claims have been cancelled, and claims 25-30 have been newly added. Thus, claims 1-30 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/11/2026 has been entered.
Claim Objections
Claim 23 is objected to because of the following informalities: Claim 23, lines 4-5 recites, “wherein the inflatable bladder in inflated”; it is suggested to amend the claim to recite --is inflated-- to make the claim more grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 4 and 30 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 4, line 2 recites, “wherein the frequency is at least 5 cycles per minute per leg of the user”. The limitation “per leg of the user” is unclear because it is unclear whether, when the device is used with two legs, the frequency is required to be at least 5 cycles per minute or 10 cycles per minute (5 cycles multiplied by two legs).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 4 and 30 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claims 4 and 30, line 2 of claim 4 recites, “wherein the frequency is at least 5 cycles per minute per leg of the user” and lines 1-3 recites, “wherein a total area . . . is less than 60 sq in per leg of the user”, the limitation “per leg of the user” which appear to positively recite part of the human body in combination with the structure of the claimed invention. Applicant needs to clearly state using inferential language (e.g. configured to, adapted to, etc.) so that the human anatomy is not claimed.
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 of this title, 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.
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 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.
Claim(s) 1, 4-6, 9-12, 14-15, 23-26, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arkans et al (2016/0175184) in view of Souma (2014/0024986) and Rousso (2007/0173886).
Regarding claim 1, Arkans discloses a DVT prevention and/or mitigation device comprising: a wearable band (104) (inflatable cuff unit) for each leg of a user (can include a left and right cuff unit) (para [0049]), the wearable band (104) including a single inflatable bladder (108) (calf cuff portion) having an inflatable portion (inflatable cuff unit can include one of the calf cuff, and includes one bladder per cuff) (para [0038]), a majority of the inflatable portion of the inflatable bladder (108) being positionable between the user's knee and a midpoint of the user's gastrocnemius muscle when the wearable band is disposed about a leg of the user (calf cuff portion (108) is configured to be positioned on a user’s cuff, and therefore is considered to be positionable between the user's knee and a midpoint of the user's gastrocnemius muscle when the wearable band is disposed about a leg of the user), the inflatable bladder (108) being inflatable to apply pressure to a portion of the user's gastrocnemius muscle (para [0038]); a compressed air source (200) (pump) coupled to the wearable band (104) configured to deliver to the inflate the inflatable portion of the inflatable bladder (108) in successive compression cycles (pump (200) includes a pressurization pump (202) coupled to a pressure tank (204)) (para [0045]), and as shown in figs 3-5, each compression cycle having a compression period (t1-t3) and a peak inflation pressure (p3) (para [0066]), at a frequency of at least 3 compression cycles per minute per leg (cycle period of about 20 seconds) (para [0068); and an air control system configured to regulate the inflation and deflation of the inflatable portion of the inflatable bladder (104) by the compressed air source (200), the air control system including: a solenoid valve (238) (inflation valves can be solenoid valves) (para [0072]) positioned in an air pathway between the inflatable portion of the inflatable bladder (108) and the compressed air source for controlling the flow of air through the air pathway, wherein air is able to flow to the inflatable portion from the compressed air source (200) when the solenoid valve (238) is open and air is prevented from flowing to the inflatable portion (108) from the compressed air source (200) when the solenoid valve (238) is closed for each wearable band (104) (para [0053]), a pressure sensor (244) (pressure sensor) positioned to monitor a pressure of air released from the solenoid valve (238) to the inflatable portion of the inflatable bladder (108) (para [0057]) and a control board (210, 212) (control, monitoring circuits) coupled to the pressure sensor (238) (para [0046]) and configured to control the opening and closing of the solenoid valve (238) (para [0047]) to provide, for each compression cycle, a compression period (period between t3 and t4 shown in fig 4) and a peak inflation pressure (p3 shown in fig 4) (para [0066]).
Arkans does not disclose the solenoid valve and pressure sensor is provided for each wearable band.
However, Souma teaches a limb compression device including a first cuff unit (301) for a right lower limb and a second cuff unit (302) for a left lower limb (para [0040]), and as shown in fig 4, each cuff unit including a pressure control unit (400) (para [0043]) each including valves (405) and pump (406) to control the inflation and deflation of each cuff (para [0047]) and a pressure sensor (402) (para [0045]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Arkans by providing, for each wearable band, a solenoid valve positioned in an air pathway between the inflatable portion of the inflatable bladder and the compressed air source for controlling the flow of air through the air pathway, wherein air is able to flow to the inflatable portion from the compressed air source when the solenoid valve is open and air is prevented from flowing to the inflatable portion from the compressed air source when the solenoid valve is closed for each wearable band, a pressure sensor positioned to monitor a pressure of air released from the solenoid valve to the inflatable portion of the inflatable bladder and a control board coupled to the pressure sensor and configured to control the opening and closing of the solenoid valve as taught by Souma in order to allow each of the two wearable bands to be indendently controlled and operated (Souma, para [0030]).
The now-modified Arkans’s device does not disclose that the compression period is about 150 ms to 250 ms and a peak inflation pressure of about 35 mmHg to about 75 mmHg to induce periods of recirculatory flow comprising reverse venous flow in the venous valve sinuses of the user's veins proximal from the site of compression, from each successive inflation.
However, Rousso teaches a compression therapy wrap configured to provide compression to a user, wherein a duration of a compression period of about 150 ms to about 250 ms (pressure application range can be less than 300 ms or less than 100 ms) (para [0014], [0093]), and in providing a venous suction effect, a peak inflation of 60-100 mmHg (para [0093]), to induce periods of recirculatory flow comprising reverse venous flow in the venous valve sinuses of the user's veins proximal from the site of compression, from each successive inflation (system is configured to induce a venous suction effect by a rapid fall in pressure at the end of each pressure cycle) (para [0092]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that the compression period is about 150 to 250 ms and a peak inflation pressure is about 35 mmHg to about 75 mmHg to induce periods of recirculatory flow comprising reverse venous flow in the venous valve sinuses of the user's veins proximal from the site of compression, from each successive inflation as taught by Rousso in order to allow the device to provide a venous suction effect, and Rousso teaches that a compression period range of 300 ms or less than 100 ms and a peak inflation pressure of 60-100 mmHg is a known duration of time and pressure for compressive therapy to induce a venous suction, and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
The now-modified Arkans’s device is considered to induce periods of recirculatory flow comprising reverse venous flow in the venous valve sinuses of the user's veins proximal from the site of compression, from each successive inflation, as Rousso discloses the compression inducing a venous suction and therefore would be operable to induce a reverse venous flow caused by the venous suction. Furthermore, a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations (Ex parte Masham, 2 USPQ2d 1647 (1987)). The apparatus of modified Arkans has the same claimed structure and is configured to perform compressions with the same claimed frequency, peak inflation pressure, and duration of the compression period. Both apply IPC therapy to a user's leg and thus the apparatus taught by Arkans, and therefore, would perform the same function of inducing reverse venous flow in the venous valve sinuses of the user's veins proximal from the site of compression, from each successive inflation.
Regarding claim 4, modified Arkans discloses a compression cycle.
Modified Arkans does not disclose the frequency is at least 5 cycles per minute per leg of the user.
However, Rousso teaches a compression therapy wrap configured to provide compression to a leg of a user, wherein the device is can be configured to provide a venous suction effect (para [0092]), and the frequency of cycles can be between 5 and 75 seconds (0.8-12 cycles per minute).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that frequency is at least 5 cycles per minute per leg of the user as taught by Rousso in order provide suitable parameters for providing a venous suction effect (Rousso, para [0092]), and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 5, Arkans the successive compression cycles produce a substantially equivalent hemodynamic effect on each compression cycle (as shown in fig 5, each cycle is shown to be identical, and therefore would produce a substantially equivalent hemodynamic effect on each compression cycle).
Regarding claim 6, the modified Arkans’s reference discloses the successive compression cycles are configured to induce a pulse of forward flow in deep veins of the user that causes a period of reversing flow in the venous valve sinus (compression cycles are configured to produce a venous suction effect which causes the pressure in at the veins to drop below normal, which would facilitate a period of reversing flow in the venous valve sinus) (Rousso, para [0092]); and furthermore, a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations (Ex parte Masham, 2 USPQ2d 1647 (1987)). The apparatus of modified Arkans has the same claimed structure and is configured to perform compressions with the same claimed frequency, peak inflation pressure, and duration of the compression period. Both apply IPC therapy to a user's leg and thus the apparatus taught by Arkans, and therefore, would perform the same function of inducing a pulse of forward flow in deep veins of the user that causes a period of reversing flow in the venous valve sinus.
Regarding claim 9, Arkans discloses the air control system is further configured to control the opening and closing of the solenoid valve (238) to provide a time to peak inflation of the bladder that is 50 ms or less (a fast acting valve can be used to inflate a cuff bladder in tens of milliseconds) (para [0015]).
Regarding claim 10, the modified Arkans’s reference discloses a compression period of the bladder is 150 ms to 250 ms (Rousso, para [0014], [0093]).
Regarding claim 11, Arkans discloses the air control system is further configured to control the opening and closing of the solenoid valve (238) (para [0053]) to provide an inflation period of the inflatable bladder (108) from about 10 ms to about 150 ms (bladder can be inflated in less than 100 ms) (para [0019]).
Regarding claim 12, the modified Arkans’s reference discloses the peak inflation pressure is about 50 mmHg to about 65 mmHg (peak inflation of 60-100 mmHg (Rousso, para [0093]), and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05).
Regarding claim 14, Arkans discloses the inflation period comprises a peak inflation period defined by a duration to the sustained peak inflation pressure can be in the tens of milliseconds (para [0015]), and with a total inflation time of the sum of 2 30 ms pulses, and therefore the duration would be about 60 ms (para [0067]).
Regarding claim 15, the modified Arkans’s reference discloses the peak inflation pressure is about 45 mmHg to about 75 mmHg (peak inflation of 60-100 mmHg (Rousso, para [0093]), and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05)
Regarding claim 17, the modified Arkans’s device is configured to perform the compressions as claimed, and the modified Arkans’s reference discloses that the compressions are configured to induce a venous suction (Rousso, para [0092]), and therefore, because the modified Arkans’s device performs the same compressions as claimed, would also be configured to induce recirculatory flow in the venous valve sinus located in a deep vein proximate a groin of the user.
Regarding claim 18, the modified Arkans’s device is configured to perform the compressions as claimed, and the modified Arkans’s reference discloses that the compressions are configured to induce a venous suction (Rousso, para [0092]), and therefore, because the modified Arkans’s device performs the same compressions as claimed, would also be configured so that the successive compression cycles are configured to induce both peak simultaneous forward venous flow and reverse venous flow during a period in which the inflatable bladder is inflating.
Regarding claim 19, modified Arkans discloses the compressed air source is configured to deliver compressions to a user's leg.
Modified Arkans does not disclose the compressed air source is configured to deliver compressions to a user's leg at a frequency of about 6 compressions per minute per leg of the user.
However, Rousso teaches a compression therapy wrap configured to provide compression to a leg of a user, wherein the device is can be configured to provide a venous suction effect (para [0092]), and the frequency of cycles can be between 5 and 75 seconds (0.8-12 cycles per minute).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that the compressed air source is configured to deliver compressions to a user's leg at a frequency of about 6 compressions per minute per leg of the user as taught by Rousso in order provide suitable parameters for providing a venous suction effect (Rousso, para [0092]), and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 20, modified Arkans discloses the compressed air source is configured to deliver compressions to a user's leg.
Modified Arkans does not disclose the compressed air source is configured to deliver compressions to a user's leg at a frequency of about 12 compressions per minute per leg of the user.
However, Rousso teaches a compression therapy wrap configured to provide compression to a leg of a user, wherein the device is can be configured to provide a venous suction effect (para [0092]), and the frequency of cycles can be between 5 and 75 seconds (0.8-12 cycles per minute).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that the compressed air source is configured to deliver compressions to a user's leg at a frequency of about 12 compressions per minute per leg of the user as taught by Rousso in order provide suitable parameters for providing a venous suction effect (Rousso, para [0092]), and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 23, the modified Arkans’s references discloses the control board (200, 212 of Arkans) is configured to control the opening and closing of the solenoid valve (238 of Arkans) (para [0047]) to provide, for each compression cycle: an inflation period from about 10 ms to about 150 ms (bladder can be inflated in less than 100 ms) (para [0019]); wherein the inflatable bladder (108 of Arkans) is inflated to the peak pressure by the compressed air source (202, 204) (Arkans, para [0045]); a holding period from about 100 ms to about 350 ms (duration of a compressed phase is less than 300 ms) (Rousso, para [0093]), wherein a pressure in the bladder is maintained within a desired predetermined range of the peak pressure (Rousso, para [0093]); and a deflation period, wherein the inflatable bladder is deflated (transition from compressed to relaxed state) (Rousso, para [0093]).
Regarding claim 24, the modified Rousso’s references discloses the inflation period is 50 ms or less (inflation period can be in the tens of milliseconds (para [0015]), and with a total inflation time of the sum of 1 30 ms pulse, and therefore the duration would be about 30 ms (para [0067]), wherein the peak inflation pressure is 45 mm Hg to 75 mm Hg (Rousso, para [0093]).
Modified Arkans does not disclose the compressed air source is configured to deliver compressions to a user's leg at a frequency of about 12 compressions per minute per leg of the user.
However, Rousso teaches a compression therapy wrap configured to provide compression to a leg of a user, wherein the device is can be configured to provide a venous suction effect (para [0092]), and the frequency of cycles can be between 5 and 75 seconds (0.8-12 cycles per minute).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that the compressed air source is configured to deliver compressions to a user's leg at a frequency of about 12 compressions per minute per leg of the user as taught by Rousso in order provide suitable parameters for providing a venous suction effect (Rousso, para [0092]), and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 25, Arkans discloses the compressed air source comprises an air storage tank (204) (pressure tank) and an air compressor (202) (pressurization pump) configured to fill and pressurize the air storage tank (204) to a predetermined pressure between compression periods (para [0045]).
Regarding claim 26, Arkans discloses air storage tank (204) (pressure tank) configured to be pressurized to a predetermined pressure (20 PSI) (para [0048]), which is considered to be is selected based on a target pressure of the inflatable bladder, as the predetermined pressure is suitable for providing pulses of pressures (para [0067]).
Regarding claim 29, modified Arkans discloses an air storage tank.
Modified Arkans does not disclose a volume ratio of the air storage tank to the inflatable bladder is from 1:1 to 3:1.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that a volume ratio of the air storage tank to the inflatable bladder is from 1:1 to 3:1, as wherein the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arkans et al, Souma, and Rousso et al as applied to claim 1 above, and further in view of Nicholson (3,901,221).
Regarding claim 2, modified Arkans discloses a DVT prevention device.
Modified Arkans does not disclose each compression cycle is configured to allow venous flow rate recovery between successive compressions such that, in deep veins of the user, the venous flow rate reaches a level that is substantially equivalent to their baseline flow rate between the successive compressions.
However, Nicholson teaches a system for simulation of blood circulation in the limbs (abstract), wherein the compression cycle is configured to allow venous flow rate recovery between successive compressions such that, in deep veins of the user, the venous flow rate reaches a level that is substantially equivalent to their baseline flow rate between the successive compressions (as shown in figs 1-2, blood flow during a period of no compression returns to a baseline prior to the next compression and blood then returns to the normal flow characteristics prior to the next pressure pulse) (col 2, ln 40-47).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that each compression cycle is configured to allow a venous flow rate to return to a baseline flow rate before a next compression as taught by Nicholson in order to prevent blood statis in the cusps which form directional valves of the veins (Nicholson, col 2, ln 41-59).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arkans et al, Souma, and Rousso et al as applied to claim 1 above, and further in view of Lee (“Investigation of Blood Flow During Intermittent Pneumatic Compression and Proposal of a New Compression Protocol” to Lee, hereinafter “Lee”).
Regarding claim 3, modified Arkans discloses a DVT prevention device.
Modified Arkans does not disclose the compression cycle is configured to induce a venous flow rate in the deep veins of the user between the successive compression cycles that returns to a resting baseline venous flow rate within 1 to 10 seconds after each compression period.
However, Lee teaches a method for applying compression for blood flow improvement (introduction) wherein the compression cycle is configured to induce a venous flow rate in the deep veins of the user (see fig 1 and “Introduction”: IPC therapy is used to induce venous flow to prevent DVT) between the successive compression cycles that returns to a resting baseline venous flow rate within 1 to 10 seconds after each compression period (see fig 3 and “Compressive protocols”: The compressive cycles applied resulted in the venous flow rate returning to baseline within 1-10 seconds after the compression period).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that the compression cycle returns to the resting baseline venous flow rate within 1 to 10 seconds after each compression period because Lee teaches that this typical during IPC therapy and that the venous flow rate returns to baseline within that time when intermittent compression is applied.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arkans et al, Souma, and Rousso et al as applied to claim 1 above, and further in view of NPL “Shear stimulation of FOXC1 and FOXC2 differentially regulates cytoskeletal activity during lymphatic valve maturation” to Norden, hereinafter “Norden” and NPL “Intermittent pneumatic compression in fracture and soft-tissue injuries healing” to Khanna, hereinafter “Khanna”.
Regarding claim 7, modified Arkans disclose the device configured to provide compression cycles with a frequency, peak inflation pressure, and a duration of the compression period.
Modified Arkans does not disclose the frequency, the peak inflation pressure, and a duration of the compression period are selected to stimulate endothelial FOXC2 expression in an endothelium of the valve sinus.
However, Norden teaches a shear stress in a valve induces FOXC2 expression (page 21, “Discussion”, first paragraph) and Khanna teaches that IPC treatment increases shear stress in endothelial cells (Khanna, page 148, “Improvement in vascularity”, first paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that the frequency, the peak inflation pressure, and a duration of the compression period are selected to induce shear stress in an epithelial cell, which would stimulate endothelial FOXC2 expression in an endothelium of the valve sinus as taught by Norden and Khanna in order to stimulate endothelial FOXC2 expression in an endothelium of the valve sinus.
Furthermore, a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations (Ex parte Masham, 2 USPQ2d 1647 (1987)). The apparatus of modified Arkans has the same claimed structure and is configured to perform compressions with the same claimed frequency, peak inflation pressure, and duration of the compression period. Both apply IPC therapy to a user's leg and thus the apparatus taught by Arkans, and therefore, would be expected to perform the same function of stimulating endothelial FOXC2 expression in an endothelium of the valve sinus as claimed.
Claim(s) 8, 13, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arkans et al, Souma, and Rousso et al as applied to claims 1 and 12 above, and further in view of Lowe et al (2012/0172774).
Regarding claim 8, modified Arkans discloses a bladder sized and shaped to apply pressure to a user’s gastrocnemius (calf).
Modified Arkans does not disclose the inflatable bladder is sized and shaped to apply pressure to the user's gastrocnemius over an area of about 25 sq. in.
However, Lowe teaches a compression therapy wrap that can be applied to a leg of a user (para [0006]), and wherein the wrap is sized and shaped to apply pressure over an area of about 25 sq in (treatment area of the wrap will range from about 0.15 sq.-feet to about 6 sq.-feet, which equals 21.9 sq in to 864 sq in) (para [0164]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that inflatable bladder is sized and shaped to apply pressure to the user's gastrocnemius over an area of about 25 sq. in as taught by Lowe, as Lowe teaches that the claimed area is within a range of a known area to apply therapy to a user, Arkans teaches that the pressure is applied on a gastrocnemius (calf) of a user, and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 13, modified Arkans discloses an inflatable bladder sized to apply pressure to a user’s gastrocnemius (calf).
Modified Arkans does not disclose the inflatable bladder is sized to apply pressure to the user's gastrocnemius over an area of less than 30 sq in.
However, Lowe teaches a compression therapy wrap that can be applied to a leg of a user (para [0006]), and wherein the wrap is sized and shaped to apply pressure over an area of about 25 sq in (treatment area of the wrap will range from about 0.15 sq.-feet to about 6 sq.-feet, which equals 21.9 sq in to 864 sq in) (para [0164]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that inflatable bladder is sized and shaped to apply pressure to the user's gastrocnemius over an area of less than 30 sq in as taught by Lowe, as Lowe teaches that the claimed area is within a range of a known area to apply therapy to a user, Arkans teaches that the pressure is applied on a gastrocnemius (calf) of a user, and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 30, modified Arkans discloses an inflatable bladder sized to apply pressure to a user’s gastrocnemius (calf).
Modified Arkans does not disclose a total area of compression applied to the user by the DVT prevention and/or mitigation device is less than 60 sq. in. per leg of the user.
However, Lowe teaches a compression therapy wrap that can be applied to a leg of a user (para [0006]), and wherein the wrap is sized and shaped to apply pressure over an area less than 60 sq. in. (treatment area of the wrap will range from about 0.15 sq.-feet to about 6 sq.-feet, which equals 21.9 sq in to 864 sq in) (para [0164]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that inflatable bladder is configured pressure, wherein a total area of compression applied to the user by the DVT prevention and/or mitigation device is less than 60 sq. in. per leg of the user as taught by Lowe, as Lowe teaches that the claimed total area of compression is within a range of a known area to apply therapy to a user, and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arkans et al, Souma, and Rousso et al as applied to claim 1 above, and further in view of Cook (2011/00004132).
Regarding claim 16, modified Arkans discloses an inflatable bladder.
Modified Arkans does not disclose a flexible overwrap disposed over at least a portion of the inflatable bladder and secured to the wearable band, the flexible overwrap configured to cinch the wearable band during inflation of the inflatable bladder.
However, Cook teaches a calf wrap for compression therapy, including an inflatable bladder (4-6) and a flexible overwrap (1) (wrap) disposed over at least a portion of the inflatable bladder (4-6) and secured to the wearable band, the flexible overwrap configured to cinch the wearable band during inflation of the inflatable bladder (4-6) (para [0025]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans by providing a flexible overwrap disposed over at least a portion of the inflatable bladder and secured to the wearable band, the flexible overwrap configured to cinch the wearable band during inflation of the inflatable bladder as taught by Cook in order to provide a means to secure the inflatable bladder to users of different sizes (Cook, para [0028]).
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arkans et al, Souma, and Rousso et al as applied to claim 1 above, and further in view of Meredith (3,179,103).
Regarding claim 21, modified Arkans discloses the device configured to provide compression cycles
Modified Arkans does not disclose successive compression cycles average a single leg ratio of non-compression time to compression time of about 45 to about 75.
However, Meredith teaches a calf wrap for compression therapy, wherein successive compression cycles average a single leg ratio of non-compression time to compression time of about 45 to about 75 (pulse of pressure is applied over a period of time of 0.1 to 1 second, and idle period is typically from 10-300 times the duration of the pulse of pressure) (col 1, ln 62-72).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans by configuring the compression successive compression cycles average a single leg ratio of non-compression time to compression time of about 45 to about 75, as a ratio of non-compression time to compression time of about 10-300 is known in the art for elimination of venous stasis to treat thrombosis, and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 22, modified Arkans discloses the device configured to provide compression cycles
Modified Arkans does not disclose the device configured to produce a dwell time of 10 seconds or less.
However, Meredith teaches a calf wrap for compression therapy, wherein a dwell time is 10 seconds or less (device is configured to pulses of pressure with a dwell time (idle period) between pulses of 5 to 150 seconds) (col 1, ln 62-72).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans by configuring the device to produce a dwell time of 10 seconds or less, as a dwell time of 5 to 150 seconds is known in the art for elimination of venous stasis to treat thrombosis, and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arkans et al, Souma, and Rousso et al as applied to claims 25-26 above, and further in view of Pickett et al (2014/0276287).
Regarding claim 27, modified Arkans discloses an air storage tank (204 of Arkans), and a target pressure of the inflatable bladder is 35 mmHg to about 75 mmHg (0.68 to 1.45 PSI) (Rousso, para [0093])
Modified Arkans does not disclose the predetermined pressure of the air storage tank is set to be 1.5 to 3 times the target pressure of the inflatable bladder.
However, Pickett in fig 4 teaches an inflatable compression therapy device including a plurality of bladders (64) and an air control system including an air compressor (50), an air storage tank (52), and a pressure regulator (54), wherein a predetermined pressure of the air storage tank is set to be from about 1 PSI to about 5 PSI (pressure relief valve (56) may be set to any pressure from about one PSI to about five PSI (para [0049]), and therefore a predetermined pressure of the air storage tank would be about 1-5 PSI, as any pressure greater than the set pressure of the pressure relief valve (56) would actuate the valve (56)).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that the predetermined pressure of the air storage tank is set to be 1-5 PSI as taught by Pickett in order to provide a suitable pressure of an air storage tank to inflate inflatable bladders for a compression therapy device. The now-modified Arkans’s device is considered to have the predetermined pressure of the air storage tank set to be 1.5 to 3 times the target pressure of the inflatable bladder, as the predetermined pressure of the air storage tank is set to be 1-5 PSI (Pickett, para [0049]), a target pressure of the inflatable bladder is 35 mmHg to about 75 mmHg (0.68 to 1.45 PSI) (Rousso, para [0093]) and therefore, 1.5-3 times the target pressure would be 1.02-4.35 PSI, which overlaps the range of the storage tank taught by Pickett, and and in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 27, modified Arkans discloses an air storage tank (204 of Arkans) configured to have a predetermined pressure.
Modified Arkans does not disclose the predetermined pressure is from 1 psi to 5 psi.
However, Pickett in fig 4 teaches an inflatable compression therapy device including a plurality of bladders (64) and an air control system including an air compressor (50), an air storage tank (52), and a pressure regulator (54), wherein a predetermined pressure of the air storage tank is set to be from about 1 PSI to about 5 PSI (pressure relief valve (56) may be set to any pressure from about one PSI to about five PSI (para [0049]), and therefore a predetermined pressure of the air storage tank would be about 1-5 PSI, as any pressure greater than the set pressure of the pressure relief valve (56) would actuate the valve (56)).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Arkans so that the predetermined pressure of the air storage tank is set to be 1-5 PSI as taught by Pickett in order to provide a suitable pressure of an air storage tank to inflate inflatable bladders for a compression therapy device.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-24 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. Furthermore, modified Arkans is considered to induce periods of recirculatory flow comprising reverse venous flow in the venous valve sinuses of the user's veins proximal from the site of compression, from each successive inflation, as Rousso discloses the compression inducing a venous suction and therefore would be operable to induce a reverse venous flow caused by the venous suction. Furthermore, a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations (Ex parte Masham, 2 USPQ2d 1647 (1987)). The apparatus of modified Arkans has the same claimed structure and is configured to perform compressions with the same claimed frequency, peak inflation pressure, and duration of the compression period. Both apply IPC therapy to a user's leg and thus the apparatus taught by Arkans, and therefore, would perform the same function of inducing reverse venous flow in the venous valve sinuses of the user's veins proximal from the site of compression, from each successive inflation. Therefore, the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kamm et al (2003/0009119) discloses a compression device configured to provide compression to stimulate blood vessel wall shear stress to promote healing.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785