DETAILED ACTION
This office action is in response to the claims filed 5/17/2024. Claims 1-20 are presenting pending in this application.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1, lines 17-18 recite, “wherein the controller is configured to active (sic) the at least one electrode, compression pump, or both”, which is grammatically incorrect.
Claim 4, lines 1-2 recites, “wherein the resistance device is one of a pneumatic, hydraulic or spring piston”. Paragraph [0027] of the Specification recites, “A “resistance device” as used in this disclosure is any device that provides force in opposition to a subject’s movements. Resistance device 128 may include, but is not limited to, a foot pedal, cycling machine, and/or other device.” If it is intended that the resistance device is a device such as a foot pedal, cycling machine, and/or other device that incorporates a piston to provide the resistance, it is suggested to amend the claim to recite --wherein the resistance device comprises one of a pneumatic, hydraulic or spring piston-- so that it is clear that the resistance device is not solely a piston.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“A stimulation unit, wherein the stimulation unit is configured to stimulate and/or move at least a portion of the body part of the subject through activation of at least one of the at least one electrode” in claims 1, 15, and 16, with corresponding structure of a controller that can activate an electrode in a stimulator (120) or a compression pump (118) (para [0026]).
“A resistance device, wherein the resistance device is configured to apply a force to the portion of the body part of the subject” in claims 3 and 13, with corresponding structure of a device that provides force in opposition to a subject’s movements, including, but is not limited to, a foot pedal, cycling machine, and/or other device.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 7-8 and 15-16 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.
Claim 7 recites the limitation "the exercise unit" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 15-16 recite the limitation "the stimulation unit" in line 2 of claim 15 and line 4 of claim 16. There is insufficient antecedent basis for this limitation in the claims.
Claim(s) 8 is/are rejected for being either directly or indirectly depending from a rejected claim base.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 10-12, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feinstein (2013/0085420) in view of Avni (2012/0238924).
Regarding claim 1, Feinstein discloses a system for prevention or amelioration of deep-vein thrombosis (DVT) edema or muscle atrophy, or for stimulating a muscle or stimulating the movement of a body part of a subject (abstract), the system comprising: an attachable device (317) (sleeve), the attachable device (317) comprising: at least one electrode (303) configured to stimulate a portion of the body part of the subject (para [0061]); a compression unit (318) configured to apply pressure to the portion of the body part of a subject (para [0061]); and in fig 2a discloses a controller (14) (control unit) in electrical communication with the attachable device (317) (para [0040]), the controller (14) comprising: a stimulation unit (11, 16, 18) (control unit (14) is configured to control a plurality of modalities including continuous passive motion (CPM) (11), functional electric stimulation (FES), and DVT prophylactic stimulation (18)) (para [0040]), wherein the stimulation unit (11, 16, 18) is configured to stimulate and/or move at least a portion of the body part of the subject through activation of at least one of the at least one electrode (13) (electrode can perform functional electric stimulation (FES)) (para [0040]); wherein the controller (14) is configured to active the at least one electrode (13) (via FES (16)) (para [0044]) or compression unit (31) (via the DVT prophylactic stimulation (18)) (para [0044]).
Feinstein does not disclose the compression unit comprises an air bladder configured to apply pressure to the portion of the body part of a subject; and an air inlet port fluidically connected to the air bladder and an air inlet port fluidically connected to the air bladder; a controller including a compression pump; and at least one air tube connecting an outlet of the compression pump to the air inlet port of the attachable device wherein the controller is configured to activate the compression pump.
However, Avni in fig 5 teaches a device for applying compression to a user including a compression unit (leg sleeve) (para [0163]) including an air bladder configured to apply pressure to the portion of the body part of a subject (para [0161]); and an air inlet port (1211) (hose plug) fluidically connected to the air bladder (para [0165]); a controller (1215) (pump includes a controller with a pump control knob (1215) to control pump operation) including a compression pump (1204) (para [0165]); and at least one air tube (1203) (hose) connecting an outlet of the compression pump (1204) to the air inlet port (1211) of the attachable device wherein the controller (1215) is configured to active the compression pump (1204) (para [0165])
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 Feinstein by configuring the compression unit to include an air bladder configured to apply pressure to the portion of the body part of a subject and an air inlet port fluidically connected to the air bladder and an air inlet port fluidically connected to the air bladder, providing the controller with a compression pump; and providing at least one air tube connecting an outlet of the compression pump to the air inlet port of the attachable device wherein the controller is configured to activate the compression pump as taught by Avni, as the use of a compression unit including air bladder and an air inlet port and a controller configured to activate a compression pump to provide air to the compression unit using a hose is known in the art, and it appears that the device of modified Feinstein would perform equally well to allow the compression unit to provide compression it a user’s body part using an air bladder and a compression pump controlled by a controller. See MPEP 2143(I)(A).
Regarding claim 2, Feinstein discloses the stimulation (11, 16, 18) unit is further configured to activate the at least one electrode (13 (FES)) based on data generated from a sensor of the attachable device (as shown in f9gs 4a-b, attachable device may include a transmission layer (203) configured to measure a response or activity of a body part) (para [0054]), in a closed loop algorithm (information is communicated to the neuromuscular feedback component (106), neurofeedback mechanism (105), and biomechanical component (109) (para [0054]), which is used to adjust the FES modality (para [0044]).
Regarding claim 10, Feinstein discloses controller (14) is configured to operate the stimulation unit (11, 16, 18) in one of a plurality of operation modes (controller (14) can operate the device to perform CPM (11), FES (16), and/or DVT prophylactic stimulation (18)) (para [0040]).
Regarding claim 11, Feinstein discloses a device whose ordinary use discloses a method of preventing or ameliorating deep-vein thrombosis (DVT) edema or muscle atrophy of a subject or a method of stimulating a muscle or movement of a body part of the subject, the method comprising: placing an attachable (317) (sleeve) device on a body part (320) (leg) of the subject (para [0059]), the attachable device (317) comprising: at least one electrode (303) configured to stimulate a portion of the body part of the subject (para [0061]); a compression unit (318) configured to apply pressure to the portion of the body part of a subject (para [0061]); selecting an operation mode of a controller (14) in communication with the attachable device (317) (controller (14) includes an input unit (103) for manipulating and programming the coordinated sequence into the microcontroller (102), and controller (14) can provide different modalities including CPM (11), FES (16), and/or DVT prophylactic stimulation (18)) (para [0043]); and applying stimulation to the body part of the subject through the at least one electrode (13) (para [0054]), applying pressure to the body part through the compression unit (318) (para [0046]), or both, based on the operation mode (different modalities can be performed simultaneously) (para [0014]).
Feinstein does not disclose compression unit includes an air bladder configured to apply pressure to the portion of the body part of the user, and an air inlet port fluidly connected to the air bladder.
However, Avni in fig 5 teaches a device for applying compression to a user including a compression unit (leg sleeve) (para [0163]) including an air bladder configured to apply pressure to the portion of the body part of a subject (para [0161]); and an air inlet port (1211) (hose plug) fluidically connected to the air bladder (para [0165]); a controller (1215) (pump includes a controller with a pump control knob (1215) to control pump operation) including a compression pump (1204) (para [0165]); and at least one air tube (1203) (hose) connecting an outlet of the compression pump (1204) to the air inlet port (1211) of the attachable device wherein the controller (1215) is configured to active the compression pump (1204) (para [0165])
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 method the device of Feinstein by configuring the compression unit to include an air bladder configured to apply pressure to the portion of the body part of a subject and an air inlet port fluidically connected to the air bladder and an air inlet port fluidically connected to the air bladder, providing the controller with a compression pump; and providing at least one air tube connecting an outlet of the compression pump to the air inlet port of the attachable device wherein the controller is configured to activate the compression pump as taught by Avni, as the use of a compression unit including air bladder and an air inlet port and a controller configured to activate a compression pump to provide air to the compression unit using a hose is known in the art, and it appears that the device of modified Feinstein would perform equally well to allow the compression unit to provide compression it a user’s body part using an air bladder and a compression pump controlled by a controller. See MPEP 2143(I)(A).
Regarding claim 12, the modified Feinstein’s references discloses applying stimulation further comprises inflating or deflating the air bladder of the attachable device (Feinstein, para [0046]).
Regarding claim 20, Feinstein discloses the portion of the body part of the subject is a leg (para [0037]).
Claim(s) 3-4, 7, 13-14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feinstein and Avni as applied to claims 1 and 10 above, and further in view of Alvarez (2020/0376322).
Regarding claims 3 and 13, modified Feinstein discloses a CPM device (11) configured to apply a force to a body part of the subject (provide a range of motion to a leg (32)) (Feinstein, para [0037]).
Modified Feinstein does not disclose the CPM device is a resistance device, wherein the resistance device is configured to apply a force to the portion of the body part of the subject.
However, Alvarez teaches a rehabilitation device, wherein the device is configured as a resistance device configured to provide force in opposite to a subject’s movements (provides adjustable, constant resistance as extension and flexion exercises are done) (abstract).
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 Feinstein by substituting the CPM device of modified Feinstein with the resistance device of Alvarez, in order to provide a device which provides a resistance in a range of motion so that the knee and the muscles surrounding it are strengthened or exercised and prevent the muscles from atrophying (Alvarez, para [0007]).
Regarding claim 4, the modified Feinstein’s reference discloses the resistance device is a pneumatic piston (resistance may be provided by pneumatic actuators with corresponding piston/cylinder sets) (Alvarado, para [0032]).
Regarding claim 7, the modified Feinstein’s reference discloses the exercise unit (100 of Alvarez) includes a track (106 of Alvarez) (base rails) (Alvarez, para [0026]) with a footplate (130 of Alvarez), the footplate (130 of Alvarez) operable to slide along the track (106 of Alvarez) (Alvarez, para [0028]).
Regarding claim 14, the modified Feinstein’s reference discloses the resistance device (100 of Alvarez) includes one of an ankle flexion device or a heel slide device (130 of Alvarez) (heel of a user can slide along base rails (1406 of Alvarez) when a user’s foot is placed in footplate (130 of Alvarez) (Alvarez, para [0028]).
Regarding claim 17, the modified Feinstein’s reference discloses providing variable resistance to the body part of the subject through the resistance device (device can provide resistance that can be customized for each range of motion for the patient) (Alvarez, para [0046]).
Claim(s) 5-6, 8, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feinstein, Avni, and Alvarez as applied to claims 3, 7, and 13 above, and further in view of Akiba et al (2017/0100586).
Regarding claim 5, modified Feinstein discloses a resistance device.
Modified Feinstein does not disclose a sensor configured to determine a position of a foot of the subject.
However, Akiba teaches a resistance device (10) (exercise device (10) can include a load generation section (40) that can provide resistance to a pedal section (21)) (para [0044]), wherein the device includes a sensor (26) (encoder) to determine a position of a subject (para [0046]).
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 Feinstein by providing a sensor configured to determine a position of a foot of the subject as taught by Akiba in order to provide position information to determine when electrical stimulation of a leg should be performed for providing an exercise for performing a stepping motion (Akiba, fig 17, para [0074]).
Regarding claim 6, modified Feinstein discloses a resistance device.
Modified Feinstein does not disclose the resistance device is a heel or ankle flexion device.
However, Akiba teaches a resistance device (10) (exercise device (10) can include a load generation section (40) that can provide resistance to a pedal section (21)) (para [0044]), and in figs 3-4 discloses the resistance device configured to perform heel or ankle flexion (para [0047]).
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 Feinstein by configuring the resistance device to perform flexion and dorsiflexion of the ankle in conjunction with flexion of the knee to perform patterns based on bending and extension, stepping or walking to be accurately applied to the leg (Akiba, para [0072])
Regarding claim 8, modified Feinstein discloses a resistance device including a track.
Modified Feinstein does not disclose the track includes a linear sensor configured to determine a position of the footplate on the track.
However, Akiba teaches a resistance device (10) (exercise device (10) can include a load generation section (40) that can provide resistance to a pedal section (21)) (para [0044]), wherein the resistance device includes a track (23) (rail) and a linear sensor (26) (encoder) configured to determine a position of a footplate (21) (pedal section) on the track (para [0046]).
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 Feinstein by providing the track with a linear sensor configured to determine a position of the footplate on the track as taught by Akiba in order to provide position information to determine when electrical stimulation of a leg should be performed for providing an exercise for performing a stepping motion (Akiba, fig 17, para [0074]).
Regarding claim 15, modified Feinstein discloses selecting an operation mode.
Modified Feinstein does not disclose selecting the operation mode comprises selecting an exercise mode, wherein upon selection of the exercise mode the stimulation unit activates the at least one electrode and applies a force to the body part of the subject through the resistance device.
However, Akiba teaches a resistance device (10) (exercise device (10) can include a load generation section (40) that can provide resistance to a pedal section (21)) (para [0044]), wherein the device is configured to operate in an exercise mode (user performs a leg press) (para [0042]) wherein a stimulation unit (100) (electrical stimulation device) activates at least one electrode (110) (electrode pads) (para [0054]) and applies a force to the body part (performs electrical stimulation) of the subject through the resistance device (while performing a leg press, figs 9-12, para [0064]).
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 method of modified Feinstein by providing an exercise mode, wherein upon selection of the exercise mode the stimulation unit activates the at least one electrode and applies a force to the body part of the subject through the resistance device as taught by Akiba in order to provide electrical stimulation for muscle strength training for complex motions performed in everyday life such as walking (Akiba, paras [0005]-[0006]).
Regarding claim 16, modified Feinstein discloses a resistance device.
Modified Feinstein does not disclose detecting a movement of the body part of the subject through a sensor of the resistance device in communication with the controller; and activating, by the stimulation unit, the at least one electrode in a closed feedback loop based on the detected movement.
However, Akiba teaches a resistance device (10) (exercise device (10) can include a load generation section (40) that can provide resistance to a pedal section (21)) (para [0044]), wherein the resistance device is configured to detect a movement of the body part of the subject through a sensor (26) (encoder) of the resistance device (10) (para [0046]) in communication with a controller (28) (para [0053]); and activating, by a stimulation unit (100) (electrode pads) (para [0054]), at least one electrode (110) (electrode pads) in a closed feedback loop based on the detected movement (as shown in fig 17, different electrode pads Ch1-4 are activated based on the position of a user’s foot detected by the encoder (26) acquiring information on the pedal section (21)) (fig 17, para [0074]).
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 method of modified Feinstein by configuring the device to detect a movement of the body part of the subject through a sensor of the resistance device in communication with the controller; and activating, by the stimulation unit, the at least one electrode in a closed feedback loop based on the detected movement as taught by Akiba in order to determine when electrical stimulation should be performed for providing an exercise for performing a stepping motion (Akiba, fig 17, para [0074]).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feinstein, Avni, and Alvarez as applied to claim 13 above, and further in view of Mason (2022/0126169).
Regarding claim 18, modified Feinstein discloses a resistance device.
Modified Feinstein does not disclose calculating a force of a movement of the body part of the subject through a sensor of the resistance device in communication with the controller.
However, Mason teaches a resistance device (104) (electromechanical device (104) can be operated in a resistive mode) (para [0081]), and in fig 4 discloses the resistance device (104) configured to calculate a force of a movement of a body part of the subject through a sensor of the resistance device in communication with the controller (at block (406), a processing device may measure force applied to pedals of the electromechanical device as a user operates (e.g., pedals) the electromechanical device) (para [0124]).
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 method of modified Feinstein by configuring the device to calculate a force of a movement of the body part of the subject through a sensor of the resistance device in communication with the controller as taught by Mason in order to allow the device to adjust the resistance applied by the resistance to ensure that the patient is exercising the affected body part as rigorously as desired during the mode (Mason, para [0126]).
Regarding claim 19, the modified Feinstein’s reference discloses adjusting a resistance level of the resistance device based on the force (at block (406 of Mason), forced applied to the resistance device is measured (Mason, para [0124]), and at block (410 of Mason), if a measured force exceeds a maximum force parameter, the resistance parameter may be reduced (Mason, para [0126]).
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement for reasons for allowance: The closest prior art of the record, Feinstein, Avni, Alvarez, and Mason disclose the limitations of claim 8. However, neither Feinstein, Avni, Alvarez, Mason, nor the other prior art of record, disclose the stimulation unit is further configured to provide resistance through the resistance device based on data generated from the linear sensor in a closed feedback loop as recited in claim 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Welsh et al (2021/0069050), Hornbach et al (2013/0231596), Tumey (5,674,262), and Samec (2022/0346714) disclose devices configured to provide compression therapy, electrical muscle stimulation, and/or resistance or continuous passive motion therapy.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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