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
Per the amendments to the drawings, the drawing objections have been withdrawn.
Per the amendments to the claims, the claim objections, the 35 U.S.C. 112(b) rejections, and the 35 U.S.C 101 rejection have been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11 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.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1: the recitation “based on the gait cycle of a hemiplegic patient”, should read ---based on the gait cycle of the hemiplegic patient”, to provide proper antecedent basis.
Claim 6: the recitation “a sole being in contact with the ground” and the recitation “a sole being separated from the ground”, should read ---the sole being in contact with the ground--- and ---the sole being separated from the ground---, to provide proper antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 and 10 are rejected under 35 U.S.C. 103 as being obvious over Polygerinos (US 20190336315 A1) in view of Herr (US 20100113980 A1), and further in view of Digital Resource Foundation (https://web.archive.org/web/20200220022944/https://www.oandplibrary.org/alp/chap13-01.asp)[2], hereinafter DRF.
Regarding claim 1, Polygerinos discloses a robotic leg orthosis for gait rehabilitation training (Polygerinos [0008]; a soft robotic orthosis for gait restoration (gait rehabilitation training) for an ankle – which is part of the leg), comprising:
an orthosis that is installed on at least one of a knee, an ankle joint, a shin, and a calf of an affected leg which is a rehabilitation target (Polygerinos [0008]; where the orthosis is for rehabilitation of an ankle and [0049] where the ankle joint is encompassed by the device);
wherein the orthosis comprises: an air chamber which is mounted so as to be connected to a sleeve (Figure 1 below; where one of the (air chambers) ‘18’ are side actuators that inflate to provide support and stability to the patient (air chamber) that are mounted so as to be connected to the sleeve ‘14’, the other air chambers including ‘22’, and ‘70’, ‘74’ of Polygerinos Figure 4c that are connected to the sleeve ‘14’);
and provides assisting strength to at least one of the knee, the ankle joint, the shin, and the calf (Polygerinos [0007]; soft robotics can be used to strengthen the user and [0047]; device is for rehabilitation to an ankle);
and start supporting an ankle so as to inhibit inversion or eversion bending of an ankle joint in the terminal swing phase and maintain ankle support so as to inhibit the inversion or eversion bending of the ankle joint for the loading response phase to the terminal stance phase (Polygerinos [0050]; where the actuator inflates or deflates the bladders to provide dorsiflexion during the swing phase of the gait cycle, [0011]; the actuator supports the angle and limits inversion and eversion of the user’s foot).
Polygerinos is silent to the robotic orthosis being for a hemiplegic patient-gait rehabilitation training and a 7 phase gait cycle.
Herr discloses a lower extremity system comprising:
a robotic leg orthosis for hemiplegic patient-gait rehabilitation training (Herr [0003-0004]; where the device is to help a patient’s gait cycle through a lower extremity prosthetic, orthotic and exoskeleton apparatus where the device intended to give more power to an individual that survives a stroke, helping a person with leg weakness walk again) comprising:
gait phases, assisting dorsiflexion and assisting plantarflexion (Herr Figure 1a; gait phases, [0006]; assisting and controlling plantarflexion and dorsiflexion).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the robotic leg orthosis of modified Polygerinos to include rehabilitating a hemiplegic patient through gait training with assisting dorsiflexion and assisting plantarflexion as taught by Herr, since, it allows for the user to have more power when walking, with leg weakness, with additional help for stroke survivors with such problems (Herr [003-004]).
Modified Polygerinos is silent to all of the phases of the gait cycle and stretching the knee joint during a specific phase of the cycle.
DRF discloses a gait analysis wherein:
wherein a gait phase of the patient includes a loading response phase, a mid stance phase, a terminal stance phase, a pre-swing phase, an initial swing phase, a mid swing phase, and a terminal swing phase (DRF Phases of Gait: Initial Contact, Loading Response, Midstance, Terminal Stance, Preswing, Initial Swing, Mid Swing, Terminal Swing);
and wherein, based on the gait cycle of a patient, enable a knee joint to be stretched in the terminal swing phase and enable a state in which the knee is stretched to be maintained for the loading response phase to the terminal stance phase (DRF Joint Motion [03]; where the knee experiences different levels and phases of flexion and extension in each gait cycle – stretching, Terminal Swing [01]; complete knee extension, Loading Response [05]; knee is flexed, Midstance [07[; knee is flexed, Terminal Stance [08]; knee is extending);
and assist dorsiflexion for the initial swing phase to the terminal swing phase, assist dorsiflexion in the loading response phase, and assist plantarflexion for the mid stance phase to the pre-swing phase (DRF Phases of Gait: Midstance [03]; the ankle is plantarflexed at the beginning of this phase, Terminal stance [02]; ankle is plantarflexed, Preswing [05]; ankle is plantarflexed, Initial Swing [04]; ankle is dorsiflexed, Midswing [04]; ankle is dorsiflexed, Terminal Swing [04]; ankle is dorsiflexed, Loading Response [03]; ankle is plantarflexed - but in order for the next phase to happen, the ankle gets dorsiflexed to the mid stance phase).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the of robotic leg orthosis by including the natural 7 gait phases, with plantarflexion and dorsiflexion as needed as taught by DRF, since, these phases are the natural phases of limb action – gait cycle – (DRF Gait Cycle [01]) and because this would allow for less fatigue, better balance, and for energy saving of the individual with use in walking, since natural movement through the gait cycle would be being restored.
Although DRF does not explicitly state that the knee joint stretches, it would have been readily understood by a person of ordinary skill in the art that the natural gait cycle extends and flexes the knee. This movement stretches the joint during the gait cycle.
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Figure 1: Annotated Figure 2 of Polygerinos.
Regarding claim 2, modified Polygerinos in view of DRF further discloses the robotic leg orthosis for gait rehabilitation training according to claim 1, wherein the orthosis comprises a first ankle supporting member that is installed at an ankle so as to inhibit inversion or eversion bending of the ankle and wherein the first ankle supporting member comprises: an ankle sleeve surrounding an ankle joint (Figure 1 above; where there is a first ankle supporting member that is installed at the ankle and that comprises an ankle sleeve ‘14’ and would help to inhibit inversion or eversion of the ankle and Polygerinos [0049]; specifically where the (side actuators) air chambers ‘18’ help to prevent inversion or eversion of the ankle);
and ankle supporting chambers which are one of the air chambers mounted to be connected to the ankle sleeve and which, when air is introduced therein to inflate the ankle supporting chambers, support the ankle joint so as to inhibit inversion or eversion bending of the ankle (Figure 1 above; where ‘18’ are side actuators (air chambers) that are mounted/connected to the ankle sleeve ‘14’ and inhibit inversion or eversion to the ankle by inflating and are placed across the ankle joint for support and can be on either side of the ankle: Polygerinos [0049]).
Regarding claim 3, modified Polygerinos in view of DRF further discloses the robotic leg orthosis for gait rehabilitation training according to claim 2, wherein the ankle supporting chambers surround both inversion and eversion sides of an ankle, respectively (Figure 1 above; where the side actuators ‘18’ (air chambers) can be on either sides of the ankle and act as an ankle wrap brace (air chamber surrounds), and inhibit inversion and eversion of the ankle Polygerinos [0049] – thereby surrounding inversion and eversion sides of the ankle by being on the inner or outer side, additionally the other side actuators ‘70’ (air chambers) of Polygerinos Figure 4c, are provided on both inversion and eversion sides (left/right) of an ankle);
wherein air is injected into the ankle supporting chambers before the affected leg reaches ground (Polygerinos [0055]; the front actuator array ‘22’ (air chamber as previously described) is inflated at push off of a gait cycle and maintains its inflated state while in a swing state (inflation before the affected reaches the ground);
and the ankle supporting chambers are inflated to provide assisting strength so as to inhibit inversion or eversion bending of the ankle (Figure 1 above; where ‘18’ are side actuators (air chambers) that are mounted/connected to the ankle sleeve ‘14’ and inhibit inversion or eversion to the ankle by inflating and are placed across the ankle joint for support and can be on either side of the ankle: Polygerinos [0049]);
and wherein the ankle supporting chambers maintain pressure therein in a stance phase to provide assisting strength so as to inhibit inversion or eversion bending of the ankle and maintain a stretched state (Polygerinos [0055]; where during the stance phase, the side actuators ‘18’ (air chambers) maintain their inflated state (maintain pressure) and [0049] where the side actuators ‘18’ (air chambers) inhibit either inversion or eversion of the ankle – the side actuators ‘18’ (air chambers) would allow the ankle to maintain a stretched state as will because they maintain pressure).
Regarding claim 10, modified Polygerinos in view of DRF further discloses the robotic leg orthosis for gait rehabilitation training according to claim 1, wherein the sleeve is made of an elastic material, and wherein the air chambers are made of a soft material (Polygerinos [0048]; where the sleeve is made of an elastic material and [0008]; where the actuators may be made from a soft material, where actuators are the air chambers (‘18’,’22’,70’,’74’)).
Claim 4 is rejected under 35 U.S.C. 103 as being obvious over Polygerinos (US 20190336315 A1) in view of Herr (US 20100113980 A1), and further in view of Digital Resource Foundation (https://web.archive.org/web/20200220022944/https://www.oandplibrary.org/alp/chap13-01.asp)[2], hereinafter DRF, and even further in view of Shorter et al. (https://ieeexplore.ieee.org/document/6104405)[1], hereinafter, Shorter.
Regarding claim 4, modified Polygerinos in view of DRF further discloses the robotic leg orthosis for gait rehabilitation training according to claim 1.
Modified Polygerinos in view of DRF fails to disclose a second ankle supporting member, a shin sleeve, guards, and artificial muscle packs connected to the guards.
Shorter discloses a leg orthosis,
wherein the orthosis comprises a second ankle supporting member that is configured to be installed on at least one of a shin and a calf such that an ankle is flexed toward a dorsum or a sole of a foot (Figure 2 below; where there is a second ankle supporting member that is installed on a shin and the ankle is flexed toward the dorsum/ sole of a foot with the device on);
and wherein the second ankle supporting member is configured to comprise: a shin sleeve surrounding the shin (Figure 2 below; shin sleeve surrounding the shin);
guards that are installed at both the shin and the calf, respectively (Figure 2 below; where there is guard on the shin (shin guard) side and a guard on the calf (calf guard) side);
and artificial muscle packs that are connected to the respective guards and have one of the air chambers inside (Figure 3 below; where there are artificial muscle packs (artificial dorsiflexor and artificial plantar flexor) that are connected to the guards (Figure 2 below; guards) and the artificial muscles are powered by pneumatics (air) – (Figure 6 Description), making the artificial muscles air chambers with air inside).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the robotic leg orthosis of modified Polygerinos in view of DRF to include a second ankle supporting member with guards and artificial muscles as taught by Shorter, since, this configuration further allows for net power to be provided to the ankle to help restore normal walking function (Shorter 2. Active AFOs for Patient Diagnosis and Rehabilitation [01]).
Claim 6 is rejected under 35 U.S.C. 103 as being obvious over Polygerinos (US 20190336315 A1), in view of Herr (US 20100113980 A1), and further in view of Digital Resource Foundation (https://web.archive.org/web/20200220022944/https://www.oandplibrary.org/alp/chap13-01.asp)[2], hereinafter DRF, further in view of Shorter (https://ieeexplore.ieee.org/document/6104405)[1], and even further in view of Blumensohn (WO 2010146593 A1).
Regarding claim 6, modified Polygerinos in view of DRF, further in view of Shorter further discloses the robotic leg orthosis for gait rehabilitation training according to claim 4.
Shorter discloses the leg orthosis wherein,
wherein the artificial muscle packs are installed at both sides of the shin and the calf, respectively (Figure 3 below; where the artificial muscles are air chambers and they are installed at both sides of the shin and the calf, respectively).
Polygerinos in view of Shorter is silent to the state in which a sole is on the ground or separated from the ground, where air is either injected into the calf or the shin’s air chamber.
Blumensohn discloses a control unit for generating time dependent pressure of a shin region based on a calf region wherein,
wherein the orthosis is configured to discharge air from the artificial muscle pack positioned at the side of the shin and inject air into the artificial muscle pack positioned at the side of the calf in response to a sole being in contact with the ground (Blumensohn Detailed description of embodiments [06]; where during walking the device allows for a periodically fluctuating pressure to the limb that is synchronized with the pump and Figure 3; where ‘30’ describes the sole touching the ground, and the processor activated the actuating unit to relax the shin region – air injected towards shin is deflated, a band ‘15’ of Blumensohn Figure 1 is configured around the calf and can inflate/deflate based on the timing of the state of the limb Detailed description of embodiments [01], Summary of invention [02]);
and wherein the orthosis is further configured to inject air into the artificial muscle pack positioned at the side of the shin and discharge air from the artificial muscle pack positioned at the side of the calf in response to a sole being separated from the ground (Blumensohn Detailed description of embodiments [06]; where during walking the device allows for a periodically fluctuating pressure to the limb that is synchronized with the pump and Figure 3; where ‘40’ describes the sole not touching the ground, and the processor activated the actuating unit to increase pressure to the shin region – air injected towards shin inflates, a band ‘15’ of Blumensohn Figure 1 is configured around the calf and can inflate/deflate based on the timing of the state of the limb - Detailed description of embodiments [01], Summary of invention [02]).
Although Blumensohn does not explicitly disclose where when the shin region deflates, that the calf region inflates or vice versa, Blumensohn does disclose the shin deflating/inflating based on the gait cycle as respectively described before and time dependency of the actuating unit to deliver a pressure in the band of air to a respected region of the lower leg (calf/shin). It would have been readily understood by one of ordinary skill in the art that, using the actuation unit with the processor could also be configured to deflate the shin region while the calf region is inflated or vice versa based on the gait cycle positions as seen in Blumensohn Figure 3, because it is understood that the calf region can inflate and/or deflate based on the timing of the state of the limb in Detailed description of embodiments [01] and Summary of invention [02].
Furthermore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the air chambers of modified Polygerinos in view of DRF, further in view of Shorter to include a control unit that activates an actuating unit to generate time dependent pressure of a shin region based on a calf region as taught by Blumensohn, since, such units help with monitoring the state of the limb continuously and varying the amount of pressure applied to the limb based on the current state of the limb muscles (Blumensohn Summary of the invention [01]).
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Figure 2: Annotated Figure D of Shorter.
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Figure 3: Annotated Figures A/B of Shorter.
Claims 7-9 are rejected under 35 U.S.C. 103 as being obvious over Polygerinos (US 20190336315 A1) in view of Herr (US 20100113980 A1), further in view of Digital Resource Foundation (https://web.archive.org/web/20200220022944/https://www.oandplibrary.org/alp/chap13-01.asp)[2], hereinafter DRF and even further in view of Mann (US 5462517 A).
Regarding claim 7, modified Polygerinos in view of DRF discloses the robotic leg orthosis for gait rehabilitation training according to claim 1.
Modified Polygerinos in view of DRF is silent to a knee stretching member.
Mann discloses a functional knee brace wherein,
a knee stretching member which is provided to be installable on a knee so as to provide assisting strength for enabling a knee to be stretched (Figure 4 below; where there is a knee stretching member that is installable on the knee for assisting in providing strength, Mann [09]; where the support elements are flexible to provide a means to set the knee in fixed positions – enables the knee to be stretched);
and wherein the knee stretching member is configured to comprise: a knee sleeve surrounding a knee joint (Figure 4 below; where there is a knee sleeve);
and knee supporting chambers which are one of the air chambers mounted to be connected to the knee sleeve (Figure 4 below; where ‘30’ and ‘32’ are pockets for the air chambers ‘34’ that are mounted to be connected to the knee sleeve);
and which, when air is introduced therein to inflate the knee supporting chambers, are also configured to enable the knee to be stretched by supporting the knee joint (Figure 4 below; where air is introduced into the air chambers by ‘58’ and this to support the patient’s knee in a designated position – Mann [05]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the robotic leg orthosis of modified Polygerinos in view of DRF to include a knee stretching member with a knee sleeve and knee supporting chambers as taught by Mann, since the knee stretching member allows the knee to be supported in multiple positions and still be flexible, thereby helping with the stretching of a leg (Mann [06],[08],[09]).
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Figure 4: Annotated Figures 10-13 of Mann.
Regarding claim 8, Modified Polygerinos in view of DRF, further in view of Mann further discloses the robotic leg orthosis for gait rehabilitation training according to claim 7, wherein the knee supporting chambers are located at both sides of a rear surface portion of the knee joint, respectively (Figure 4 above; where the air chambers ‘34’ inside of pockets ‘30’ and ‘32’ are on a rear surface (as indicated by the arrows) of both sides of the knee joint).
Regarding claim 9, Modified Polygerinos in view of DRF, further in view of Mann further discloses the robotic leg orthosis for gait rehabilitation training according to claim 7, wherein the knee stretching member enables the knee joint to be stretched in a swing phase and enables a state in which the knee is stretched to be maintained in a stance phase (Figure 4 above; where the knee stretching member enables the knee joint to be stretched and support while walking through the knee supporting chambers (‘34’ inside of ‘30’ and ‘32’) on the back of the knee, during walking there would be a swing phase and a stance phase – so by wearing the knee stretching member, it is enabling the knee to stretched in both the stance and the swing phase).
Claim 11 is rejected under 35 U.S.C. 103 as being obvious over Polygerinos (US 20190336315 A1), in view of Herr (US 20100113980 A1), further in view of Digital Resource Foundation (https://web.archive.org/web/20200220022944/https://www.oandplibrary.org/alp/chap13-01.asp)[2], hereinafter DRF, further in view of Clark (WO 2012167205 A1) and even further in view of Chen (CN 113301828 A).
Regarding claim 11, modified Polygerinos in view of DRF further discloses the robotic leg orthosis for gait rehabilitation training according to claim 1.
Modified Polygerinos in view of DRF fails to disclose a luggage carrier comprising an air tank, air compressor, pressure regulator, camera, and a laser distance sensor.
Clark discloses a portable ventilator with an oxygen generator, further comprising:
a luggage carrier that generates compressed air and is capable of supplying the generated compressed air to the air chambers (Clark [0061]; where the portable ventilation system is capable of being in a rolling suitcase (luggage carrier), [0065]; where the air compressor pump ‘204’ that is within the portable ventilation system generates the compressed air and is capable of supplying air to the patient [0005], which would have the air chambers on them);
wherein the luggage carrier comprises: an air compressor which generates compressed air (Clark [0065]; where the air compressor pump ‘204’ compresses air and Figure 7A; portable ventilation system capable of being in a rolling suitcase (luggage carrier) – [0061]);
an air tank which stores the generated compressed air (Clark [0036]; where the pressure accumulator ‘214’ accumulates compressed air, and the pressure accumulator ‘214’ may comprise a tank);
and a pressure regulator which regulates pressure of the compressed air (Clark [0036]; where the air pressure regulator ‘208’ regulates air pressure and [0047]; where the ventilator receives an oxygen supply of compressed air and the air pressure regulator regulates the air pressure of the air).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the robotic leg orthosis of modified Polygerinos in view of DRF to include a luggage carrier with an air tank, pressure regulator and an air compressor as taught by Clark, since this would house the source of air to a patient and because a luggage carrier provides a more portable and cost-effective system for the patient to gain access to the compressed air (Clark [0005], [0024]).
Modified Polygerinos in view of DRF, further in view of Clark fails to disclose wherein the luggage carrier comprises a camera and a laser distance sensor.
Chen discloses an intelligent luggage system wherein,
the luggage carrier comprises a laser distance sensor which is capable of sensing a distance between a patient (Chen Contents of the invention [02]; a laser emitter and proximity sensor ‘45’, ‘50’ (laser distance sensor) helps move the luggage in a given direction to ovoid the obstacle (sensing a distance), Specific implementation examples [04]; the sensor can detect targets such as the user);
and a camera that is capable of imaging a location of the patient such that the luggage carrier is capable of performing autonomous driving so as to follow the patient by recognizing the location of the patient (Chen Specific implementation examples [06]; the camera ‘40’ is coupled to the top part of the pull rod ‘31’ and [02]; the smart luggage system ‘100’ can perform autonomous driving and follow a user).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the robotic leg orthosis of modified Polygerinos in view of DRF, further in view of Clark to include a camera and a laser distance sensor within the luggage carrier, since this system allows for target (user) tracking to maintain the movement of the luggage with respect to a user when they are moving (Chen Target tracking system based on ultra-wideband [04]).
References Cited
[1] K. A. Shorter, J. Xia, E. T. Hsiao-Wecksler, W. K. Durfee and G. F. Kogler, "Technologies for Powered Ankle-Foot Orthotic Systems: Possibilities and Challenges," in IEEE/ASME Transactions on Mechatronics, vol. 18, no. 1, pp. 337-347, Feb. 2013, doi: 10.1109/TMECH.2011.2174799.
[2] 13: Normal gait: O&P virtual library. 13: Normal Gait | O&P Virtual Library. (2020, February 20). https://web.archive.org/web/20200220022944/https://www.oandplibrary.org/alp/chap13-01.asp
Conclusion
The following prior art were considered but not used on a 35 U.S.C. § 102 or 103 rejection:
Luis (WO 2019132677 A2): device for aiding plantar flexor muscles.
Sutti (US 20190192327 A1): stretch cord assembly.
Wang (CN 107042504 A) Jump assisting mechanical exoskeleton system.
McBride (GB 2514314 A): air bladders in an array to be used with knees, shins etc.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is 571-272-3835. The examiner can normally be reached Monday-Friday 8am-5pm, EO Friday 8am-4pm EST.
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/AISLINN M JONES/
Examiner, Art Unit 3785
/VALERIE L WOODWARD/
Primary Examiner, Art Unit 3785
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