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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: ‘110a’ of the distal portion. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-2 and 12-13 are objected to because of the following informalities:
Claim 1 recites: “An apparatus to treat tremor in an outer extremity of a subject” but should read ---An apparatus configured to treat tremors in an outer extremity of a subject---, and “the wearable base having a proximal fixed region and a distal moving region”, should read ---the wearable base configured to have a proximal fixed region and a distal moving region--- to avoid positively citing an outer extremity of a subject and similarly claim 12 should be amended as such.
Claim 2 recites: “the patient” but should read ---the subject---, to avoid any antecedent basis issues and stay consistent with previous recitations.
Claims 12-13: claim 12 recites “wearable base worn over at least a joint”, “wearable base worn on the outer extremity” and claim 13 recites “wearable base is worn over a wrist” but should read ---wearable base (is) configured to be….--- to avoid positively reciting human body parts.
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 8 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the at least capstan or fastener" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-2, 4-8, 10, 12-13, and 15-28 are rejected under 35 U.S.C. 103 as being obvious over Shamroukh et al. (https://ieeexplore.ieee.org/document/8116809/authors#authors[1]), hereinafter Shamroukhu in view of Maxwell (US 5201772 A).
Regarding claim 1, Shamroukh discloses an apparatus to treat tremor in an outer extremity of a subject (Section I. Introduction [01]), the apparatus comprising: a wearable base (Fig. 1; spooling motor band + gyroscope band + compression sleeve) configured to be worn over at least a joint of the outer extremity (Fig. 1; worn over the patient’s arm to hand), the wearable base having a proximal fixed region (Fig. 1; spooling motor band that is stationary on the arm) and a distal moving region (Fig. 1; gyroscope band that moves with wrist movement and tensioning of the bands); and a damping mechanism (Fig.1; viscoelastic bands, Section II. Mechanical Design [01], A. Orthotic Design [01]; where the bands slide against the arm in response to the tensioning of the viscoelastic bands) coupled to the wearable base and configured to damp movement of the distal moving region relative to the proximal fixed region in response to tremor movement in the outer extremity (Fig. 1; Section II. Mechanical Design [01]; where the use of viscous dampening is to suppress tremors, A. Orthosis Design [01]; where the viscoelastic bands (connected to the distal and proximal region of the wearable base) are coiled for tension and help to suppress tremors – Section I. Introduction [05]) wherein the damping mechanism comprises at least one tension element held in tension within a body of the wearable base (Fig. 1; viscoelastic bands (2 of them) are the tension elements held within tension of the body of the wearable base (spooling motor band + gyroscope band + compression sleeve), A. Orthosis Design [01], where the tension elements act as a wire compressing and decompressing the limb to assist in damping movement), and wherein, in response to the tremor movement, the at least one tension element applies a force opposite in direction to the tremor movement to damp the movement of the distal moving region relative to the proximal fixed region (A. Orthosis Design [01]; where the viscoelastic bands connected to each region (as seen in Fig. 1), apply a force in opposite directions to dampen the movement of the regions relative to each other, Section I. Introduction [05]; for dampening of tremor movements, Section II. Mechanical design [01]; suppress tremorous pronation-supination movements).
However, Shamroukh fails to disclose that the damping mechanism is based on friction, and/or that there is a frictional damping mechanism.
Maxwell discloses in a similar field of endeavor of resistance-based tension mechanisms, a limb movement resistance device comprising:
a frictional damping mechanism and a tensioning element (Maxwell col. 6; use of a cable ‘602’ acts as a tensioning member with a capstan ‘600,604’ that creates a resistive torque to dampen limb movement - where the capstan ‘600,604’ uses friction between the cable ‘602’ and the capstan, because without friction, the cable does not tension-ably move within the capstan ‘600,604’, and the dampening force does not exist on the limb - Abstract; a resistive force is generated when a limb moves, the force acts opposite to the limb movement, and the limb movement is resisted/ dampened).
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 apparatus of Shamroukhu with the tensioning elements (viscoelastic bands) by including a frictional damping mechanism with a tensioning element as taught by Maxwell and having the tension elements be all connected together, since, the combination would prove further advantageous by further controlling unwanted or excessive movement of a person’s limb, whilst still allowing their limb’s to move (Maxwell col. 6 and Abstract) and the frictional damping acts as an added resistance to the force of the user’s movement.
Regarding claim 2, modified Shamroukhu further discloses the apparatus of claim 1, wherein the outer extremity is a hand of the subject, and wherein the wearable base is configured to be worn over a wrist and the hand of the patient (Shamroukhu Fig. 1; where the wearable base (spooling motor band + viscoelastic band + compression sleeve) is worn over the wrist of the patient and the hand of the patient).
Regarding claim 4, modified Shamroukhu further discloses the apparatus of claim 1, wherein the at least one tension element comprises at least one belt, wire, or rope (Maxwell col. 6; tensioning element ‘602’ is an aircraft cable which is a wire connected to the capstan ‘600,604’).
Regarding claim 5, modified Shamroukhu further discloses the apparatus of claim 1, wherein the at least one tension element comprises a plurality of tension elements (as modified Shamroukhu Fig. 1 discloses the tensioning elements (viscoelastic bands) and Maxwell col. 6; discloses the tensioning elements of the capstan ‘602,604’ + the cable ‘600’ of the system -thereby the modified system comprises a plurality of tension elements).
Regarding claim 6, modified Shamroukhu further discloses the apparatus of claim 1, wherein ends of the at least one tension element are fixedly attached to the distal moving region of the wearable base (Shamroukhu Fig. 1; where the at least one tension element (viscoelastic bands) are fixedly attached to the distal moving region of the wearable base (gyroscope band));
and wherein the frictional damping mechanism further comprises at least one capstan at the proximal fixed region coupled to the at least one tension element (as modified Maxwell col. 6 provides the frictional damping mechanism, with the at least one capstan ‘602,604’ that is at a proximal fixed region coupled to the at least one tension element ‘600’ cable and the viscoelastic bands of Shamrouku).
Regarding claim 7, modified Shamroukhu further discloses the apparatus of claim 6, wherein the at least one tension element is wrapped around the at least one capstan (Maxwell col. 6; where the tension element cable ‘600’ is wrapped around the at least one capstan ‘602,604’, and as modified Shamroukhu’s tensioning element bands connect to the tensioning system of Maxwell).
Regarding claim 8, modified Shamroukhu further discloses the apparatus of claim 6, wherein the frictional damping mechanism further comprises at least one adjustment element coupled to the at least one capstan or fastener to increase or decrease an amount of tension the at least one tension element is held in within the wearable base (Shamroukh A. Orthosis Design [05]; where the motor with the microcontroller acts as an adjustment element to increase or decrease the amount of tension in the system, where the tension element (viscoelastic bands) are held within the wearable base (spooling motor band + gyroscope band + compression sleeve) as modified Maxwell col. 6; frictional damping mechanism with the tension element ‘600’ of the cable with the capstan ‘602,604’ is connected to the tensioning element of the viscoelastic bands that connect to the wrist to compress/ decompress the arm to dampen limb movement).
Regarding claim 10, modified Shamroukh further discloses the apparatus of claim 1, wherein the frictional damping mechanism further comprises at least one adjustment element coupled to the wearable base to increase or decrease the pressure the wearable base exerts on the at least one tension element (Shamroukh Fig. 1 and Maxwell col. 6 as modified; when there is more tension on the material of the wearable base with the tension element of the viscoelastic bands, there would be more pressure exerted due to the force on the capstans with wires, and vice versa).
Regarding claim 12, Shamroukh discloses a method of treating tremor in an outer extremity of a subject (Section I. Introduction [01]), the method comprising:
providing a wearable base to be worn over at least a joint of the outer extremity (Fig. 1; spooling motor band + gyroscope band + compression sleeve);
and damping movement of a distal moving region of the wearable base worn on the outer extremity relative to a proximal fixed region of the wearable base in response to tremor movement in the outer extremity (Fig. 1; gyroscope band at distal part that moves with wrist movement and tensioning of the bands, proximal region: spooling motor band that is stationary on the arm, - damping movement - Section II. Mechanical Design [01]; where the use of viscous dampening is to suppress tremors, A. Orthosis Design [01]; where the viscoelastic bands (connected to the distal and proximal region of the wearable base) are coiled for tension and help to suppress tremors – Section I. Introduction [05]);
wherein damping movement comprises applying a force opposite in direction to the tremor movement in response to the tremor movement (A. Orthosis Design [01]; where the viscoelastic bands connected to each region (as seen in Fig. 1), apply a force in opposite directions to dampen the movement of the regions relative to each other, Section I. Introduction [05]; for dampening of tremor movements, Section II. Mechanical design [01]; suppress tremorous pronation-supination movements).
However, Shamroukh fails to disclose that the damping mechanism is based on friction, and/or that there is a frictional damping mechanism.
Maxwell discloses in a similar field of endeavor of resistance-based tension mechanisms, a limb movement resistance device comprising:
using a frictional damping mechanism and a tensioning element (Maxwell col. 6; use of a cable ‘602’ acts as a tensioning member with a capstan ‘600,604’ that creates a resistive torque to dampen limb movement - where the capstan ‘600,604’ uses friction between the cable ‘602’ and the capstan, because without friction, the cable does not tension-ably move within the capstan ‘600,604’, and the dampening force does not exist on the limb - Abstract; a resistive force is generated when a limb moves, the force acts opposite to the limb movement, and the limb movement is resisted/ dampened).
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 apparatus of Shamroukhu with the tensioning elements (viscoelastic bands) by including a frictional damping mechanism with a tensioning element as taught by Maxwell and having the tension elements be all connected together, since, the combination would prove further advantageous by further controlling unwanted or excessive movement of a person’s limb, whilst still allowing their limb’s to move (Maxwell col. 6 and Abstract) and the frictional damping acts as an added resistance to the force of the user’s movement.
Regarding claim 13, modified Shamroukhu further discloses the method of claim 12, wherein the wearable base is worn over a wrist and at least a portion of a hand of the subject (Shamroukhu Fig. 1; where the wearable base (spooling motor band + viscoelastic band + compression sleeve) is worn over the wrist of the patient and the hand of the patient).
Regarding claim 15, modified Shamroukh further discloses the method of claim 12, wherein the force opposite in direction to the tremor movement is applied by at least one tension element held in tension within a body of the wearable base (A. Orthosis Design [01]; where the viscoelastic bands (within the wearable base) connected to each region (as seen in Fig. 1), apply a force in opposite directions to dampen the movement of the regions relative to each other, Section I. Introduction [05]; for dampening of tremor movements, Section II. Mechanical design [01]; suppress tremorous pronation-supination movements).
Regarding claim 16, modified Shamroukh further discloses the method of claim 15, further comprising adjusting an amount of tension of the at least one tension element (Shamroukh A. Orthosis Design [05]; where the motor with the microcontroller acts as an adjustment element to increase or decrease the amount of tension in the system, where the tension element (viscoelastic bands) are held within the wearable base (spooling motor band + gyroscope band + compression sleeve) as modified Maxwell col. 6; frictional damping mechanism with the tension element ‘600’ of the cable with the capstan ‘602,604’ is connected to the tensioning element of the viscoelastic bands that connect to the wrist to compress/ decompress the arm to dampen limb movement).
Regarding claim 17, modified Shamroukhu further discloses the method of claim 16, further comprising at least one capstan at the proximal fixed region of the wearable base coupled to the at least one tension element (as modified Maxwell col. 6 provides the frictional damping mechanism, with the at least one capstan ‘602,604’ that is at a proximal fixed region of Shamroukhu coupled to the at least one tension element ‘600’ cable and the viscoelastic bands with the wearable base connect to the tensioning system of Maxwell);
wherein adjusting an amount of tension of the at least one tension element comprises adjusting a number of times the tension element is wrapped around the at least one capstan (as modified Maxwell col. 6; provides the tension element cable ‘600’ is wrapped around the at least one capstan ‘602,604’, and as modified Shamroukhu’s tensioning element bands connect to the tensioning system of Maxwell, where the capstan and the cable work together to rotate producing torque and Shamroukh A. Orthosis Design [05]; where the motor with the microcontroller acts as an adjustment element to increase or decrease the amount of tension in the system, where the tension element (viscoelastic bands) are held within the wearable base (spooling motor band + gyroscope band + compression sleeve)).
Regarding claim 18, modified Shamroukh further discloses the method of claim 12, further comprising measuring one or more characteristics of the tremor in the outer extremity of the subject (Shamroukh Figs 3-4; where the tremor characteristics of the outer extremity of the subject are measured by the gyroscope and the IMU sensors with the wearable base).
Claims 3 and 14 are rejected under 35 U.S.C. 103 as being obvious over Shamroukh (https://ieeexplore.ieee.org/document/8116809/authors#authors[1]) in view of Maxwell (US 5201772 A) and further in view of Elias (CA 2961070 A1).
Regarding claim 3, modified Shamroukhu further discloses the apparatus of claim 1, comprising the frictional damping mechanism and the wearable base (as modified Maxwell col. 6, Abstract; frictional damping mechanism, Shamroukhu Fig. 1; wearable base as previously described).
Modified Shamroukhu is silent to the wearable base having a viscoelastic material.
Elias discloses a tremor movement suppression device comprising:
a viscoelastic material of the wearable base, the viscoelastic material being configured to deform and interfere with the tremor movement in response to the tremor movement (Elias [091],[092]; where the glove (wearable base) is made of an elastomer (viscoelastic material) and is configured to compress the hand and get rid of involuntary movements but still allow for movement).
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 apparatus of modified Shamroukhu to include the wearable base being made of a viscoelastic material as taught by Elias, since, a viscoelastic material would allow the wearable base to be deformable and interfere with tremor movements, but also to still allow the user to move, just without any involuntary movements (Elias [091],[092]).
Regarding claim 14, modified Shamroukhu further discloses the method of claim 12, comprising the frictional damping mechanism and the wearable base (as modified Maxwell col. 6, Abstract; frictional damping mechanism, Shamroukhu Fig. 1; wearable base as previously described);
wherein the force opposite in direction to the tremor movement is applied by the wearable base (A. Orthosis Design [01]; where the viscoelastic bands connected to each region (as seen in Fig. 1), apply a force in opposite directions to dampen the movement of the regions relative to each other, Section I. Introduction [05]; for dampening of tremor movements, Section II. Mechanical design [01]; suppress tremorous pronation-supination movements).
Modified Shamroukhu is silent to the wearable base having a viscoelastic material.
a viscoelastic material of the wearable base, the viscoelastic material being configured to deform and interfere with the tremor movement in response to the tremor movement (Elias [091],[092]; where the glove (wearable base) is made of an elastomer (viscoelastic material) and is configured to compress the hand and get rid of involuntary movements but still allow for movement).
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 apparatus of modified Shamroukhu to include the wearable base being made of a viscoelastic material as taught by Elias, since, a viscoelastic material would allow the wearable base to be deformable and interfere with tremor movements, but also to still allow the user to move, just without any involuntary movements (Elias [091],[092]).
Claim 9 is rejected under 35 U.S.C. 103 as being obvious over Shamroukh (https://ieeexplore.ieee.org/document/8116809/authors#authors[1]) in view of Maxwell (US 5201772 A) and further in view of Danek (US 20180140452 A1).
Regarding claim 9, modified Shamroukh further discloses the apparatus of claim 1.
Modified Shamroukh is silent to the material of the wearable base.
Danek discloses an orthosis wherein:
the wearable base comprises a flexoelectric material (Danek [0037]; where the wearable base (sleeve) is made from a material such as a polyamide and spandex blend).
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 [method / device] of x to ### as taught by y, since, a polyamide material would allow for the wearable base to comfortable stretch, compress and decompress (Danek [0037]). Further a polyamide material is beneficial because it is a flexoelectric material that acts as a strong electrical insulator, where the material can hold an electric polarization, but also insulate current.
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being obvious over Shamroukh (https://ieeexplore.ieee.org/document/8116809/authors#authors[1]) in view of Maxwell (US 5201772 A) and further in view of Suarez (EP 13164478 A).
Regarding claim 11, modified Shamroukh further discloses the apparatus of claim 10.
Modified Shamroukh fails to disclose the adjustment element being controlled by a knob proximate at least one capstan.
Suarez discloses a cable adjusted orthosis assembly wherein:
at least one adjustment element is controlled by one or more knobs proximate at least one capstan (Suarez Fig. 11; ‘670’ is the adjustment element that is a knob controlling the tension in the system proximate to at least one capstan ‘720’).
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 apparatus of modified Suarez to include a physical knob that is controlling the tension in the capstan based wire system as taught by Suarez, since, it would allow for the tension in the system to be automatically and manually adjusted by the user, even whilst wearing (Suarez [0047,0048]).
Regarding claim 20, modified Shamroukh further discloses the method of claim 12, comprising a capstan at the proximal fixed region of the wearable base (as modified Maxwell col. 6 provides the frictional damping mechanism, with the at least one capstan ‘602,604’ that is at a proximal fixed region coupled to the at least one tension element ‘600’ cable and the viscoelastic bands of Shamroukhu).
Modified Shamroukh fails to disclose the adjustment element being controlled by a knob proximate at least one capstan.
Suarez discloses a cable adjusted orthosis assembly wherein:
adjusting a strength of frictional damping by rotating a knob connected to adjustment mechanisms disposed around at least one capstan at the proximal fixed region of the wearable base (Suarez Fig. 11; ‘670’ is the adjustment element that is a knob controlling the tension (strength of friction damping) in the system proximate to at least one capstan ‘720’ (frictional damping member)).
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 apparatus of modified Suarez to include a physical knob that is controlling the tension in the capstan based wire system as taught by Suarez, since, it would allow for the tension in the system to be automatically and manually adjusted by the user, even whilst wearing (Suarez [0047,0048]).
Claim 19 is rejected under 35 U.S.C. 103 as being obvious over Shamroukh (https://ieeexplore.ieee.org/document/8116809/authors#authors[1]) in view of Maxwell (US 5201772 A) and further in view of Siores (GB 2444393 A).
Regarding claim 19, modified Shamroukh further discloses the method of claim 12.
Modified Shamroukh fails to disclose a flexoelectric material of the wearable base.
Siores discloses an apparatus for tremor suppression comprising:
applying voltage to induce mechanical stress in a flexoelectric material of the wearable base, wherein the mechanical stress is opposite in direction to the tremor movement (Siores [0013]; where the piezoelectric material with an applied voltage will induce mechanical stress, [0018]; piezoelectric use for phase cancelling, [0006]; counteracting tremor force, [0016-0017]; piezoelectric incorporated into glove (wearable base), glove is made of flexible polymer [0024] – making a flexoelectric material).
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 apparatus of modified Shamroukh by including a flexoelectric material in the wearable base as taught by Siores, since, a flexoelectric material will deform in response to applied voltage, and help to further counteract tremor forces by the user (Siores [0006]).
References Cited
[1] M. Shamroukh, I. Q. Kalimullah, A. Chacko, S. S. Barlingay, V. Kalaichelvi and A. B. Chattopadhyay, "Evaluation of control strategies in semi-active orthosis for suppression of upper limb pathological tremors," 2017 International Conference on Innovations in Electrical, Electronics, Instrumentation and Media Technology (ICEEIMT), Coimbatore, India, 2017, pp. 75-80, doi: 10.1109/ICIEEIMT.2017.8116809.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Farkash (US 20190084813 A1): alternate capstan wiring assembly.
Li (CN 108478384 A): wearable hand rehabilitation device with a wiring assembly.
Lu (CN 109199661 A): alternate wearable base.
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 7:30-5, EO Friday 7:30-4.
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/AISLINN M JONES/Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
