DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the drawings, filed on 06/22/2026, have been considered, and hereby and entered in the instant application.
In light of the amendment to the drawings (filed on 06/22/2026),
Election/Restrictions
In view of the amended drawings (filed on 06/22/2026), Species A, exemplified by Figures 1-9, and Species B, exemplified by Figures 10-20, are not separated. As such, the species grouping is changed, as follows:
Species A, exemplified by Figures 1-20;
Species B, exemplified by Figures 21-29; and
Species C, exemplified by Figures 43A-43B.
Should Applicant elect on of Species A or Species B, further election of sub-species of a hand engagement member is required:
Sub-species 1, exemplified by Figures 1-9;
Sub-species 2, exemplified by Figures 21-29;
Sub-species 3, exemplified by Figure 30;
Sub-species 4, exemplified by Figures 31-32;
Sub-species 5, exemplified by Figure 33;
Sub-species 6, exemplified by Figure 34;
Sub-species 7, exemplified by Figures 35-36.
Should Applicant elect one of Species A or Species B, further election of sub-species of a force application system is required:
Sub-species 1, exemplified by Figures 1-9;
Sub-species 2, exemplified by Figures 21-29;
Sub-species 3, exemplified by Figure 37;
Sub-species 4, exemplified by Figure 38;
Sub-species 5, exemplified by Figure 39;
Sub-species 6, exemplified by Figure 41;
Sub-species 7, exemplified by Figure 42.
Should Applicant elect one of Species A or Species B, further election of sub-species of an elbow pad is required:
Sub-species 1, exemplified by Figures 1-9;
Sub-species 2, exemplified by Figures 21-29;
Sub-species 3, exemplified by Figures 44A-45.
Applicant's election with traverse of Species A, exemplified by Figures 1-9, and further election of Sub-species 1, exemplified by Figures 1-9, for each sub-species in the reply filed on 06/22/2026 is acknowledged. The traversal is on the ground(s) that in the primary species election, Species A, exemplified by Figures 1-9, and Species B, exemplified by Figures 10-20, should not be separate. In view of the amended drawings (filed on 06/22/2026), the grouping of species for the primary species election has been changed such that the primary species election includes Species A, exemplified by Figures 1-20, Species B, exemplified by Figures 21-29, and Species C, exemplified by Figures 43A-43B. As such, Applicant’s election (filed on 06/22/2026) is acknowledged as the election of Species A, exemplified by Figures 1-20, and Sub-species 1, exemplified by Figures 1-9, for each sub-species.
Claims 3, 5-6, and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/22/2026.
Status of Claims
Claims 1-27 are pending in the instant application. Claims 1-2, 4, 7-15, and 17-27 are as previously presented. Claims 3, 5-6, and 16 are withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “120a” has been used to designate both the proximal end of the first end 120 (see Fig. 2) and the distal end of the first end 120 (see Fig. 9). 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "120a" and "120b" have both been used to designate the proximal end of the first end 120; and reference characters “16a” and “160” have both been used to designate the hand engagement frame. 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.
The drawings are objected to because reference character “14” has been used to designate different parts (see Figs. 1-2, 4, 10-13, 16, 18, and 20); however, it is unclear what parts reference character “14” has been used to designate in Figures 13-15 and 17-18. 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The disclosure is objected to because of the following informalities:
[0089]: Reference character “14” is used to designate the power unit assembly; however, reference character “14” designates the force application system (see [0072])
[0091]: “lower actuator 22” should read “lower actuator 24”
[0083]: “hand support 160” should read “hand support 162”
Appropriate correction is required.
Claim Objections
Claims 1, 7-10, 13-15, 17, and 25 are objected to because of the following informalities:
Claim 1 (lines 1-2), and all further recitations: “a user's pronation, supination, flexion, extension, radial deviation, and ulnar deviation wrist movements” should read “pronation, supination, flexion, extension, radial deviation, and ulnar deviation movements of a wrist of a user” for clarity.
Claim 1 (line 17), and all further recitations: “a user’s wrist” should read “the wrist of the user” for consistency and clarity.
Claim 7 (line 6) and claim 10 (line 6): “a user’s hand” should read “a hand of the user” for clarity.
Claim 8 (line 2), claim 9 (line 2), claim 13 (line 2), claim 14 (line 2): “a user’s hand” should read “the hand of the user” for consistency and clarity.
Claim 15 (lines 6-7) and claim 17 (lines 6-7): “the user’s elbow” should read “an elbow of the user” for clarity.
Claim 25, line 2: “the arm of the user” should read “an arm of the user” for clarity and to establish antecedent basis.
Claim 25, line 7: “the distal arm member” should read “a distal arm member” to establish antecedent basis.
Claim 25, lines 8-9: “a forearm of the user” should read “the forearm of the user” for consistency and clarity.
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 4 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 4 recites the limitation "the arm support first end" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim, as an arm support and an arm support first end are not disclosed in claims 1 and 4. For the purpose of examination, “the arm support first end” will be interpreted as – the wrist portion – based on paragraph [0074] of Applicant’s specification.
Claim 4 recites the limitation "the arm support second end " in line 2. There is insufficient antecedent basis for this limitation in the claim, as an arm support and an arm support second end are not disclosed in claims 1 and 4. For the purpose of examination, “the arm support second end” will be interpreted as – the forearm portion – based on paragraph [0074] of Applicant’s specification.
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.
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.
Claims 1, 4, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Saringer & Culhane (US 5738636 A; hereinafter “Saringer”) in view of Bonutti et al. (US 20170100295 A1; hereinafter “Bonutti”).
Regarding claim 1, Saringer discloses a device (Figs. 1a, 2) for improving a user's pronation, supination, flexion, extension, radial deviation, and ulnar deviation wrist movements (see Fig. 2; col. 5, lines 31-36), the device comprising:
an arm engagement system (CPM wrist device 20, see Fig. 1a) comprising:
a wrist portion (50, 68, 72; Figs. 1a and 2) comprising a proximal end and a distal end (see Annotated Fig. 2 below), the distal end comprising a bracket (distal end of wrist portion has bracket 72, see Annotated Fig. 2 below), wherein a hand engagement member (70, 76, 78; Fig. 2) is pivotally coupled to the wrist portion by the bracket (see Fig. 2, where bracket 72 and rubber pad 68 pivotally connect the wrist portion to the hand engagement member; col. 4, lines 54-61);
a forearm portion (22, 26, 40, 44, 46; Fig. 1a) comprising a proximal end and a distal end (see Annotated Figs. 1a and 2 below), wherein the proximal end comprises a forearm pad (22, 26; see Annotated Fig. 1a below); and
a pivoting connection (52; Fig. 2) operatively coupled with the proximal end of the wrist portion and the distal end of the forearm portion (see Figs. 1a and 2), wherein the wrist portion is pivotally coupled to the forearm portion about the pivoting connection (see Figs. 1a and 2); and
a force application system (42; Fig. 1a) comprising:
a second actuator (42; Fig. 1a) operatively coupled at or near the pivoting connection (see Fig. 1a),
wherein the second actuator (42) is configured to apply a rotational force to the pivoting connection, thereby producing at least one of a flexion movement, extension movement, ulnar deviation, and radial deviation of a user's wrist (42 actuates the rotation of 52 to produce an ulnar deviation and radial deviation of a user’s wrist when the user’s wrist is positioned their palm-down, and a flexion and extension movement when the user’s wrist is positioned with their thumb up, as seen in Fig. 2; col. 4, lines 43-50; col. 5, lines 27-36).
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Saringer further discloses a locking screw (74; Fig. 1a) that is used to lock the bracket (72) at a desired location along the ring (70; see Figs. 1a and 2; col. 4, lines 57-61), such that when the locking screw (74) is loosened, the bracket (72) slides along the ring (70) to change the orientation of the user’s wrist (col. 5, line 66 to col. 6, line 10). But Saringer is silent to a first actuator operatively coupled to the hand engagement member, wherein the first actuator is configured to apply a rotational force to the hand engagement member, thereby producing at least one of a supination movement and a pronation movement to a user's wrist.
However, Bonutti teaches an analogous orthosis for the range of motion of a user’s wrist (Abstract; Fig. 1) with a cuff to engage a user’s hand (26; Figs. 1 and 3) mounted to a bracket (70; Fig. 3) that is connected to a ring (50, 52; Figs. 3 and 6). Bonutti further teaches an actuator mechanism (16; Fig. 2) including an outer surface of the ring with ring teeth (44; Fig. 2) that operatively mesh with a worm gear (40; Fig. 2), such that the rotation of an input shaft (34; Fig. 2), via the manual rotation of a knob (36; Fig. 2) or a motor ([0027]), causes the worm gear (40) to rotate along the ring teeth (44) and drives the rotation of the ring about a joint rotation axis (A2; Fig. 3; [0027]- [0028]) which produces a pronation or supination movement to the user’s wrist ([0038]; [0037]; [0030]).
Therefore, 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 an outer surface of Saringer’s ring (70) to have ring teeth, as taught by Bonutti above, and to modify Saringer’s locking screw (74) with the drive assembly (knob 26, input shaft 34, worm gear 40) taught by Bonutti above, such that the drive assembly (Bonutti 26, 34, and 40; Bonutti Fig. 2) is operatively coupled to the ring (70) via the connection between the worm gear (Bonutti 40) and the ring teeth (Bonutti 44 on outside surface of Saringer 70), such that the rotation of the input shaft (Bonutti 34, where Bonutti 34 is either manually driven to rotate via Bonutti 36 or via a motor, see Bonutti [0027]) drives the rotation of the worm gear (Bonutti 40) along the ring teeth (Bonutti 44) to produce a supination movement or pronation movement to the user’s wrist (Bonutti [0038]; [0037]; [0030]), thereby improving the range of motion of the user’s wrist (Bonutti [0024]; last sentence of Bonutti [0026]).
Regarding claim 4, Saringer as modified teaches the invention set forth in claim 1, wherein the first actuator (Bonutti 26, 34, and 40) is operatively coupled to the arm support first end (see Fig. 1a, where 74 is Bonutti 26, 34, and 40; see claim 1 above) and second actuator (42) is operatively coupled to the arm support second end (see Fig. 1a, where 42 is operatively coupled to at least 44 and 46; col. 4, lines 43-50), as best understood by the Examiner (see rejection of claim 4 under 35 U.S.C. 112(b) above for interpretation of “the arm support first end” and “the arm support second end”).
Regarding claim 25, Saringer discloses a method for manipulating body parts of a user, thereby providing pronation or supination assistance to the arm of the user about a wrist joint of the user (see Figs. 1a-4; col. 5, lines 31-36), the method comprising:
engaging a forearm of the user with a proximal arm member (22, 26, 40, 44, 46; see Fig. 1a, where forearm of user is engaged by 22 and 26) of an arm engagement system (CPM wrist device 20, see Fig. 1a);
engaging a hand of the user with a hand engagement member (70, 76, 78; see Fig. 1a), wherein the hand engagement member (70, 76, 78) is operatively coupled to the distal arm member at a pivoting connection (70 pivotally coupled to 50 via 72, see Fig. 1a) configured to allow the hand engagement member to pivot about an axis defined along a forearm of the user as the hand of the user pronates or supinates (see Annotated Fig. 2 below, where when 72 pivots along 70 a pronation movement or supination movement is applied to the user’s wrist).
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Saringer further discloses a locking screw (74; Fig. 1a) with an axis of rotation extending longitudinally through the center of the locking screw, where the locking screw is used to lock the bracket (72) at a desired location along the ring (70; see Figs. 1a and 2; col. 4, lines 57-61), such that when the locking screw (74) is loosened, the bracket (72) slides along the ring (70) to change the orientation of the user’s wrist (col. 5, line 66 to col. 6, line 10). But Saringer is silent to activating a force application mechanism to apply a force to the hand engagement member to manipulate the hand of the user to provide the pronation or supination assistance, wherein a force applicator of the force application mechanism is operatively connected between the distal arm frame and the hand engagement member.
However, Bonutti teaches an analogous orthosis for the range of motion of a user’s wrist (Abstract; Fig. 1) with a cuff to engage a user’s hand (26; Figs. 1 and 3) mounted to a bracket (70; Fig. 3) that is connected to a ring (50, 52; Figs. 3 and 6). Bonutti further teaches an actuator mechanism (16; Fig. 2) including an outer surface of the ring with ring teeth (44; Fig. 2) that operatively mesh with a worm gear (40; Fig. 2), such that the rotation of an input shaft (34; Fig. 2), via the manual rotation of a knob (36; Fig. 2) or a motor ([0027]), causes the worm gear (40) to rotate along the ring teeth (44) and drives the rotation of the ring about a joint rotation axis (A2; Fig. 3; [0027]- [0028]) which produces a pronation or supination movement to the user’s wrist ([0038]; [0037]; [0030]).
Therefore, 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 an outer surface of Saringer’s ring (70) to have ring teeth, as taught by Bonutti above, and to modify Saringer’s locking screw (74) with the drive assembly (knob 26, input shaft 34, worm gear 40) taught by Bonutti above, such that the drive assembly (Bonutti 26, 34, and 40; Bonutti Fig. 2) is operatively coupled to the ring (70) via the connection between the worm gear (Bonutti 40) and the ring teeth (Bonutti 44 on outside surface of Saringer 70), such that the rotation of the input shaft (Bonutti 34, where Bonutti 34 is either manually driven to rotate via Bonutti 36 or via a motor, see Bonutti [0027]) drives the rotation of the worm gear (Bonutti 40) along the ring teeth (Bonutti 44) to rotate the hand engagement member (70, 76, 78) between a first position (Fig. 3) and a second position (Fig. 4) to improve the range of motion of the user’s wrist by producing a supination movement or a pronation movement of the user’s wrist (Bonutti [0038], [0037], [0030], [0024], and last sentence of Bonutti [0026]).
Regarding claim 26, Saringer as modified teaches the invention set forth in claim 25, wherein the distal arm member (50) is operatively coupled to the proximal arm member (22, 26, 40, 44, 46) at a second pivoting connection (50 pivotally connected to 44 by 52, see Figs. 1a and 3-4) configured to allow the hand engagement member to pivot about an axis defined perpendicular to the forearm of the user as the hand of the user flexes or extends about the wrist (axis 98; Fig. 2; see Fig. 4, where pivoting of 50 driven by 52 provides a flexion movement or extension movement of the user’s wrist; col. 5, lines 27-36), the method further comprising:
activating the force application mechanism to apply a force to the hand engagement member to manipulate the hand of the user to provide flexion or extension assistance (activation of Bonutti 26, 34, and 40 drives 72 to pivot about 70 such that the user’s hand is oriented as depicted in Fig. 4, where this orientation of the user’s wrist allows for the pivoting of 52 and 52 to provide flexion or extension assistance to the user’s wrist; col. 6, lines 39-44), wherein a second force applicator (42; Fig. 1a) of the force application mechanism is operatively connected between the proximal arm frame and the distal arm frame (see Fig. 1a, where 42 is operatively connected between 50 and 44).
Regarding claim 27, Saringer as modified teaches the invention set forth in claim 25, wherein the distal arm member (50) is operatively coupled to the proximal arm member (22, 26, 40, 44, 46) at a second pivoting connection (50 pivotally connected to 44 by 52, see Figs. 1a and 3-4) configured to allow the hand engagement member to pivot about an axis defined perpendicular to the forearm of the user as the hand of the user radially deviates or ulnarly deviates (axis 98; Fig. 2; see Fig. 3, where pivoting of 50 driven by 52 provides an ulnar deviation or radial deviation movement of the user’s wrist; col. 5, lines 27-36), the method further comprising:
activating the force application mechanism to apply a force to the hand engagement member to manipulate the hand of the user to provide radial deviation or ulnar deviation assistance (activation of Bonutti 26, 34, and 40 drives 72 to pivot about 70 such that the user’s hand is oriented as depicted in Fig. 3, where this orientation of the user’s wrist allows for the pivoting of 52 and 52 to provide ulnar or radial deviation assistance to the user’s wrist; col. 6, lines 32-38), wherein a second force applicator (42; Fig. 1a) of the force application mechanism is operatively connected between the proximal arm frame and the distal arm frame (see Fig. 1a, where 42 is operatively connected between 50 and 44).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Saringer (US 5738636 A) in view of Bonutti (US 20170100295 A1) as applied to claim 1 above, and further in view of Bonutti et al. (US 8273043 B2; hereinafter “Bonutti ‘043”).
Regarding claim 2, Saringer as modified teaches the invention set forth in claim 1. Saringer as modified is silent to the device further comprising a seat.
However, Bonutti ’043 teaches an analogous orthosis device for use with a user’s wrist (Fig. 11) that is mounted to a fixed surface of a chair (col. 11, lines 25-26).
Therefore, 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 device of Saringer, as currently modified in claim 1 above, to be mounted to a fixed surface of a chair such that the device is stable and supported during use.
Claims 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Saringer (US 5738636 A) in view of Bonutti (US 20170100295 A1), and in further view of Kelly et al. (US 20200360169 A1; hereinafter “Kelly”).
Regarding claim 7, Saringer discloses a method of using a device (Figs. 1a and 2) for improving a user's pronation, supination, flexion, extension, radial deviation, and ulnar deviation wrist movements (see Fig. 2; col. 5, lines 31-36), the method comprising:
providing an arm engagement system (CPM wrist device 20, see Fig. 1a), the arm engagement system comprising a wrist portion (50, 68, 72; Figs. 1a and 2), a forearm portion (22, 26, 40, 44, 46; Fig. 1a), and a pivoting connection (52; Figs. 1a and 2) pivotally coupling the wrist portion and the forearm portion (see Figs. 1a and 2), wherein the wrist portion comprises a hand engagement member (70, 76, 78; Fig. 2) configured for receiving a user's hand (see Fig. 1a);
providing a force application system (42; Fig. 1a), the force application system comprising:
a second actuator (42; Fig. 1a) having a second axis of rotation (axis 96, see Fig. 2), wherein the second actuator is operatively coupled at the pivoting connection with the wrist portion and the forearm portion (see Fig. 1a); and
a controller and power supply unit (54; Fig. 1a) configured to actuate the second actuator (col. 4, lines 45-49),
wherein, when the wrist portion (50, 68, 72) and the forearm portion (22, 26, 40, 44, 46) are aligned in a straight line (see Fig. 1a), the hand engagement member is in the first position (see Fig. 3), and the controller and power supply unit (54) is in the second mode (second mode is when 54 actuates the 42; col. 4, lines 45-49), the second actuator (42) causes the arm engagement system to move a user's wrist between ulnar deviation and radial deviation (col. 6, lines 32-38; Figs. 1a and 3); and
wherein, when the wrist portion (50, 68, 72) and the forearm portion (22, 26, 40, 44, 46) are aligned in a straight line (see Fig. 1a), the hand engagement member is in the second position (see Fig. 4), and the controller and power supply unit (54) is in the second mode (second mode is when 54 actuates the 42; col. 4, lines 45-49), the second actuator (42) cause the arm engagement system to move a user's wrist between flexion and extension (col. 6, lines 39-44; Fig. 4).
Saringer further discloses a locking screw (74; Fig. 1a) with an axis of rotation extending longitudinally through the center of the locking screw, where the locking screw is used to lock the bracket (72) at a desired location along the ring (70; see Figs. 1a and 2; col. 4, lines 57-61), such that when the locking screw (74) is loosened, the bracket (72) slides along the ring (70) to change the orientation of the user’s wrist (col. 5, line 66 to col. 6, line 10). But Saringer is silent to a first actuator having a first axis of rotation, wherein the first actuator is operatively coupled to the wrist portion, and wherein the first actuator is configured to rotate the hand engagement member between a first position and a second position.
However, Bonutti teaches an analogous orthosis for the range of motion of a user’s wrist (Abstract; Fig. 1) with a cuff to engage a user’s hand (26; Figs. 1 and 3) mounted to a bracket (70; Fig. 3) that is connected to a ring (50, 52; Figs. 3 and 6). Bonutti further teaches an actuator mechanism (16; Fig. 2) including an outer surface of the ring with ring teeth (44; Fig. 2) that operatively mesh with a worm gear (40; Fig. 2), such that the rotation of an input shaft (34; Fig. 2), via the manual rotation of a knob (36; Fig. 2) or a motor ([0027]), causes the worm gear (40) to rotate along the ring teeth (44) and drives the rotation of the ring about a joint rotation axis (A2; Fig. 3; [0027]- [0028]) which produces a pronation or supination movement to the user’s wrist ([0038]; [0037]; [0030]).
Therefore, 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 an outer surface of Saringer’s ring (70) to have ring teeth, as taught by Bonutti above, and to modify Saringer’s locking screw (74) with the drive assembly (knob 26, input shaft 34, worm gear 40) taught by Bonutti above, such that the drive assembly (Bonutti 26, 34, and 40; Bonutti Fig. 2) is operatively coupled to the ring (70) via the connection between the worm gear (Bonutti 40) and the ring teeth (Bonutti 44 on outside surface of Saringer 70), such that the rotation of the input shaft (Bonutti 34, where Bonutti 34 is either manually driven to rotate via Bonutti 36 or via a motor, see Bonutti [0027]) drives the rotation of the worm gear (Bonutti 40) along the ring teeth (Bonutti 44) to rotate the hand engagement member (70, 76, 78) between a first position (Fig. 3) and a second position (Fig. 4) to improve the range of motion of the user’s wrist by producing a supination movement or a pronation movement of the user’s wrist (Bonutti [0038], [0037], [0030], [0024], and last sentence of Bonutti [0026]).
While Saringer does disclose a controller and power supply unit (54; Fig. 1a) configured to actuate the second actuator (col. 4, lines 45-49), Saringer alone or as modified by Bonutti above, is fails to teach a power unit assembly configured to actuate both the first actuator and the second actuator.
However, Kelly teaches an analogous orthotic device (see Fig. 1) with a first powered actuator assembly (165; Fig. 1; [0053]) and a second powered actuator assembly (130; Fig. 1; [0056]), where both the first powered actuator assembly and the second powered actuator assembly are electrically coupled to and powered by a battery (last sentence of [0011]; [0086]).
Therefore, 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 controller and power supply unit (54) taught by Saringer with a battery, as taught by Kelly above, such that both the first actuator (Bonutti 26, 34, and 40) and the second actuator (42) are powered and actuated by one power source (Kelly battery, see last sentence of Kelly [0011]; Kelly [0086]) to minimize the amount of hardware on or connected to the device, and thereby, improve patient comfort during use of the device.
As a result of the above modifications of Saringer, it immediately follows that when the wrist portion (50, 68, 72) and the forearm portion (22, 26, 40, 44, 46) are aligned in a straight line (see Fig. 1a), the hand engagement member is in the first position (see Figs. 1a and 3), and the power unit assembly (Kelly’s battery, see last sentence of Kelly [0011]; Kelly [0086]) is in the first mode (when Kelly’s battery is powering and actuating the first actuator; last sentence of Kelly [0011]), the first actuator (Bonutti 26, 34, and 40) causes the arm engagement system to move a user's wrist between supination and pronation (Bonutti [0038]; [0037]; [0030]).
Regarding claim 8, Saringer as modified teaches the invention set forth in claim 7, wherein when the hand engagement member is in the first position, a user's hand in the hand engagement member is positioned palm-side down (see Figs. 1a and 3).
Regarding claim 9, Saringer as modified teaches the invention set forth in claim 7, wherein when the hand engagement member is in the second position (see Fig. 4), a user's hand in the hand engagement member is in a thumb's up position (see Fig. 4, where when a bottom surface of 42 is parallel to the ground, the user’s hand is in a thumb’s up position).
Regarding claim 10, Saringer discloses a device (Figs. 1a and 2) for improving a user's pronation, supination, flexion, extension, radial deviation, and ulnar deviation wrist movements (see Fig. 2; col. 5, lines 31-36), the device comprising:
an arm engagement system (CPM wrist device 20, see Fig. 1a), the arm engagement system comprising a wrist portion (50, 68, 72; Figs. 1a and 2), a forearm portion (22, 26, 40, 44, 46; Fig. 1a), and a pivoting connection (52; Figs. 1a and 2) pivotally coupling the wrist portion and the forearm portion (see Figs. 1a and 2), wherein the wrist portion comprises a hand engagement member (70, 76, 78; Fig. 2) configured for receiving a user's hand (see Fig. 1a);
a force application system (42; Fig. 1a), the force application system comprising:
a second actuator (42; Fig. 1a) having a second axis of rotation (see Annotated Fig. 1a below), wherein the second actuator is operatively coupled at the pivoting connection with the wrist portion and the forearm portion (see Fig. 1a); and
a controller and power supply unit (54; Fig. 1a) configured to actuate the second actuator (col. 4, lines 45-49).
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Saringer further discloses a locking screw (74; Fig. 1a) with an axis of rotation extending longitudinally through the center of the locking screw, where the locking screw is used to lock the bracket (72) at a desired location along the ring (70; see Figs. 1a and 2; col. 4, lines 57-61), such that when the locking screw (74) is loosened, the bracket (72) slides along the ring (70) to change the orientation of the user’s wrist (col. 5, line 66 to col. 6, line 10). But Saringer is silent to a first actuator having a first axis of rotation, wherein the first actuator is operatively coupled to the wrist portion, and wherein the first actuator is configured to rotate the hand engagement member between a first position and a second position.
However, Bonutti teaches an analogous orthosis for the range of motion of a user’s wrist (Abstract; Fig. 1) with a cuff to engage a user’s hand (26; Figs. 1 and 3) mounted to a bracket (70; Fig. 3) that is connected to a ring (50, 52; Figs. 3 and 6). Bonutti further teaches an actuator mechanism (16; Fig. 2) including an outer surface of the ring with ring teeth (44; Fig. 2) that operatively mesh with a worm gear (40; Fig. 2), such that the rotation of an input shaft (34; Fig. 2), via the manual rotation of a knob (36; Fig. 2) or a motor ([0027]), causes the worm gear (40) to rotate along the ring teeth (44) and drives the rotation of the ring about a joint rotation axis (A2; Fig. 3; [0027]- [0028]) which produces a pronation or supination movement to the user’s wrist ([0038]; [0037]; [0030]).
Therefore, 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 an outer surface of Saringer’s ring (70) to have ring teeth, as taught by Bonutti above, and to modify Saringer’s locking screw (74) with the drive assembly (knob 26, input shaft 34, worm gear 40) taught by Bonutti above, such that the drive assembly (Bonutti 26, 34, and 40; Bonutti Fig. 2) is operatively coupled to the ring (70) via the connection between the worm gear (Bonutti 40) and the ring teeth (Bonutti 44 on outside surface of Saringer 70), such that the rotation of the input shaft (Bonutti 34, where Bonutti 34 is either manually driven to rotate via Bonutti 36 or via a motor, see Bonutti [0027]) drives the rotation of the worm gear (Bonutti 40) along the ring teeth (Bonutti 44) to rotate the hand engagement member (70, 76, 78) between a first position (Fig. 3) and a second position (Fig. 4) to improve the range of motion of the user’s wrist by producing a supination movement or a pronation movement of the user’s wrist (Bonutti [0038], [0037], [0030], [0024], and last sentence of Bonutti [0026]).
While Saringer does disclose a controller and power supply unit (54; Fig. 1a) configured to actuate the second actuator (col. 4, lines 45-49), Saringer alone or as modified by Bonutti above, is fails to teach a power unit assembly configured to actuate both the first actuator and the second actuator.
However, Kelly teaches an analogous orthotic device (see Fig. 1) with a first powered actuator assembly (165; Fig. 1; [0053]) and a second powered actuator assembly (130; Fig. 1; [0056]), where both the first powered actuator assembly and the second powered actuator assembly are electrically coupled to and powered by a battery (last sentence of [0011]; [0086]).
Therefore, 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 controller and power supply unit (54) taught by Saringer with a battery, as taught by Kelly above, such that both the first actuator (Bonutti 26, 34, and 40) and the second actuator (42) are powered and actuated by one power source (Kelly battery, see last sentence of Kelly [0011]; Kelly [0086]) to minimize the amount of hardware on or connected to the device, and thereby, improve patient comfort during use of the device.
As a result of the above modifications of Saringer, it immediately follows that when the wrist portion (50, 68, 72) and the forearm portion (22, 26, 40, 44, 46) are aligned in a straight line (see Fig. 1a), the hand engagement member is in the first position (see Figs. 1a and 3), and the power unit assembly (Kelly’s battery, see last sentence of Kelly [0011]; Kelly [0086]) is in the first mode (when Kelly’s battery is powering and actuating the first actuator; last sentence of Kelly [0011]), the first actuator (Bonutti 26, 34, and 40) causes the arm engagement system to move a user's wrist between supination and pronation (Bonutti [0038]; [0037]; [0030]).
Regarding claim 11, Saringer as modified teaches the invention set forth in claim 10, wherein, when the wrist portion (50, 68, 72) and the forearm portion (22, 26, 40, 44, 46) are aligned in a straight line (see Fig. 1a), the hand engagement member is in the first position (see Fig. 3), and the power unit assembly (Kelly’s battery, see last sentence of Kelly [0011]; Kelly [0086]) is in the second mode (when Kelly’s battery is powering and actuating the second actuator; last sentence of Kelly [0011]), the second actuator (42) causes the arm engagement system to move a user's wrist between ulnar deviation and radial deviation (col. 6, lines 32-38; Figs. 1a and 3).
Regarding claim 12, Saringer as modified teaches the invention set forth in claim 10, wherein, when the wrist portion (50, 68, 72) and the forearm portion (22, 26, 40, 44, 46) are aligned in a straight line (see Fig. 1a), the hand engagement member is in the second position (see Fig. 4), and power unit assembly (Kelly’s battery, see last sentence of Kelly [0011]; Kelly [0086]) is in the second mode (when Kelly’s battery is powering and actuating the second actuator; last sentence of Kelly [0011]), the second actuator (42) causes the arm engagement system to move a user's wrist between flexion and extension (col. 6, lines 39-44; Fig. 4).
Regarding claim 13, Saringer as modified teaches the invention set forth in claim 10, wherein when the hand engagement member is in the first position, a user's hand in the hand engagement member is positioned palm-side down (see Figs. 1a and 3).
Regarding claim 14, Saringer as modified teaches the invention set forth in claim 10, wherein when the hand engagement member is in the second position (see Fig. 4), a user's hand in the hand engagement member is in a thumb's up position (see Fig. 4, where when a bottom surface of 42 is parallel to the ground, the user’s hand is in a thumb’s up position).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Bonutti ‘043 (US 8273043 B2).
Regarding claim 15, Bonutti ‘043 discloses a device for manipulating a hand of a user (see Figs. 11-12) to provide pronation or supination assistance (see Figs. 14-15; col. 6, lines 5-7), the device comprising:
an arm engagement system (17, 25, 26, 27, 32, 41, 42; Fig. 11) including:
a proximal arm member (26, 27, 41, 42; Fig. 11) comprising a proximal arm frame (26, 41; Figs. 10-11) having a proximal end (end of 41 spaced furthest from 31, see Figs. 10-11), a distal pivot end (end of 26, 41 spaced nearest 31, see Figs. 10-11);
a distal arm member (17, 25; Fig. 11) comprising a distal arm frame (25; Fig. 11) having a proximal pivot end (end of 25 spaced nearest 31, see Fig. 9) and a distal end (end of 25 spaced furthest from 31, see Fig. 7);
a hand engagement member (32; Fig. 2) configured to receive and engage the hand of the user (see Fig. 12; col. 7, lines 34-35);
a first pivoting connection (connection between 49 and 56, see Fig. 2) operatively coupled between distal arm frame and the hand engagement member (49 and 56 couple between 32 and 17 and 25, see Fig. 2) such that the hand engagement member is configured to pivot about an axis defined along a forearm of the user as the hand of the user pronates or supinates (Figs. 1 and 14-15; col. 16, lines 15-19); and
a force application system (34; Fig. 2) comprising:
a force applicator (49, 56, 58, 60; Fig. 2) operatively connected between the distal arm frame and the hand engagement member (see Fig. 2), the force applicator (49, 56, 58, 60) configured to apply a force to the hand engagement member to manipulate the hand of the user to provide the pronation or supination assistance (col. 7, lines 56-59; col. 10, line 64 to col. 11, line 9).
While Bonutti ‘043 does disclose an elbow pad configured to engage with a bottom of the user’s elbow (44; Figs. 10-11; col. 13, lines 11-13), Bonutti ‘043 fails to disclose the elbow pad is arranged on the proximal arm frame (26, 41).
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to rearrange the elbow pad (44) to be positioned on a bottom portion of the upper arm cuff (26, 41) in the Bonutti‘043 device because Applicant has not disclosed that elbow pad being located on the proximal arm frame provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, Applicant’s disclosure states “In some embodiments, the posterior elbow pad may define an L-shape. Additionally or alternatively, the posterior elbow pad may be selectively coupled to the proximal arm frame. In some embodiments, the posterior elbow pad may include a posterior elbow pad assembly. Additionally or alternatively, the posterior elbow pad assembly may include an inner lateral support and an outer lateral support. In some embodiments, the posterior elbow pad assembly may be configured such that the inner lateral support and the outer lateral support may selectively translate in the lateral direction” (see [0013] of Applicant’s specification). One of ordinary skill in the art, furthermore, would have expected Bonutti ‘043’s elbow pad, and Applicant’s elbow pad, to perform equally well because both mechanisms perform the same function of providing support to the user’s elbow. Additionally, rearranging the elbow pad (44) to be coupled to the upper arm cuff (26, 41) in the Bonutti ‘043 device would not modify the operation of the Bonutti ‘043 device. Therefore, it would have been prima facie obvious to modify Bonutti ‘043 to obtain the invention as specified in claim 15 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired positioning and location of the elbow pad and thus fails to patentably distinguish over the prior art of Bonutti ‘043 (see MPEP 2144.04.VI.C).
Claims 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Saringer (US 5738636 A) in view of Bonutti ‘043 (US 8273043 B2).
Regarding claim 17, Saringer discloses a device (Figs. 1a and 2) for manipulating a hand of a user to provide pronation or supination assistance (see Figs. 2-4), the device comprising:
an arm engagement system (CPM wrist device 20, see Fig. 1a) including:
a proximal arm member (22, 26, 40, 44, 46; Fig. 1a) comprising a proximal arm frame (44; Fig. 1a) extending along a proximal frame longitudinal direction from proximal end to a distal pivot end (see Annotated Fig. 1a below);
a distal arm member (50, 68, 72; Figs. 1a and 2) comprising a distal arm frame (50; Fig. 1a) extending along a distal frame longitudinal direction from a proximal pivot end to a distal pivot end (see Annotated Fig. 1a below);
a hand engagement member (70, 76, 78; Fig. 2) configured to receive and engage the hand of the user (see Fig. 1a);
a first pivoting connection (52; Figs. 1a and 2) operatively coupled between the distal pivot end of the proximal arm frame and the proximal pivot end of the distal arm frame (see Fig. 1a) such that the hand engagement member is configured to pivot about an axis of rotation perpendicular to at least one of the proximal frame longitudinal direction or the distal frame longitudinal direction (axis 96, see Fig. 2); and
a force application system (42; Fig. 1a) comprising:
a force applicator (42) operatively connected between the proximal arm frame and the distal arm frame (see Fig. 1a), the force applicator configured to apply a force to the hand engagement member to manipulate the hand of the user to rotate about the axis of rotation (42 actuates the rotation of 52 such that ring 70 and the user’s hand rotate about axis 96, see Figs. 2 and 3; col. 4, lines 43-50; col. 5, lines 27-29).
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While Saringer does disclose a flexible sleeve (26; Fig. 1a) with a support (22; Fig. 1a) for the user’s forearm (col. 4, lines 22-23; Fig. 1a), Saringer fails to explicitly disclose the proximal arm member further includes a posterior elbow pad configured to engage a bottom of the user's elbow.
However, Bonutti ‘043 teaches an analogous orthosis device for use with a user’s wrist (Fig. 11) with an elbow pad configured to engage with a bottom of the user’s elbow (44; Figs. 10-11; col. 13, lines 11-13).
Therefore, 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 proximal arm member (22, 26, 40, 44, 46) to include an elbow pad configured to engage with a bottom of the user’s elbow, as taught by Bonutti ‘043 above, to improve the user’s comfort when using the device (Bonutti ‘043 col. 13, lines 29-30).
Regarding claim 18, Saringer as modified teaches the invention set forth in claim 17, wherein the hand engagement member (70, 76, 78) is configured such that applying the force to the hand engagement member manipulates the hand of the user to provide for flexion or extension assistance of the wrist (see Fig. 4, where when pivoting force from the pivoting of 52 drives the hand engagement member to pivot, flexion and extension of the user’s wrist is produced; see col. 5, line 66 to col. 6, line 3; see col. 6, lines 39-44).
Regarding claim 19, Saringer as modified teaches the invention set forth in claim 17, wherein the hand engagement member (70, 76, 78) is configured such that applying the force to the hand engagement member manipulates the hand of the user to provide for radial deviation or ulnar deviation assistance (see Fig. 3, where when pivoting force from the pivoting of 52 drives the hand engagement member to pivot, ulnar deviation or radial deviation of the user’s wrist is produced; see col. 6, lines 32-38).
Regarding claim 20, Saringer as modified teaches the invention set forth in claim 17, wherein the arm engagement system (CPM wrist device 20, see Fig. 1a) further includes a second pivoting connection (72; Fig. 1a) operatively coupled between distal arm frame and the hand engagement member (bracket 72 couples a distal end of 50 and ring 70, where 68 allows ring 70 to pivot with respect to 72, see col. 4, lines 54-57; and where bracket 72 pivots about ring 70, see Figs. 2-4, see col. 4, lines 57-61 and col. 5, line 66 to col. 6, line 10).
Regarding claim 21, Saringer as modified teaches the invention set forth in claim 20, wherein the hand engagement member (70, 76, 78) is configured to pivot about the second pivoting connection between a first position (see Fig. 4; col. 4, lines 57-61; col. 5, line 66 to col. 6, line 10) suitable for flexion or extension assistance of the wrist (see Fig. 4; col. 5, line 66 to col. 6, line 3; col. 6, lines 39-44) and a second position (see Fig. 3) suitable for radial deviation or ulnar deviation assistance (see Fig. 3; col. 6, lines 32-38).
Regarding claim 22, Saringer as modified teaches the invention set forth in claim 20, wherein the hand engagement member (70, 76, 78) is configured to pivot about the second pivoting connection (pivoting connection between 50 and 70 via 72, see claim 20 above) and about an axis defined along a forearm of the user as the hand of the user pronates or supinates (see Annotated Fig. 2 below, where when 72 pivots along 70 a pronation movement or supination movement is applied to the user’s wrist).
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Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Saringer (US 5738636 A) in view of Bonutti ‘043 (US 8273043 B2) as applied to claims 17 and 20 above, and further in view of Bonutti (US 20170100295 A1).
Regarding claim 23, Saringer as modified teaches the invention set forth in claim 20. While Saringer further teaches a locking screw (74; Fig. 1a) that is used to lock the bracket (72) at a desired location along the ring (70; see Figs. 1a and 2; col. 4, lines 57-61), such that when the locking screw (74) is loosened, the bracket (72) slides along the ring (70) to change the orientation of the user’s wrist (col. 5, line 66 to col. 6, line 10), Saringer, alone or as modified above, fails to teach the force application system further comprises: a second force applicator operatively connected between the distal arm frame and the hand engagement member.
However, Bonutti teaches an analogous orthosis for the range of motion of a user’s wrist (Abstract; Fig. 1) with a cuff to engage a user’s hand (26; Figs. 1 and 3) mounted to a bracket (70; Fig. 3) that is connected to a ring (50, 52; Figs. 3 and 6). Bonutti further teaches an actuator mechanism (16; Fig. 2) including an outer surface of the ring with ring teeth (44; Fig. 2) that operatively mesh with a worm gear (40; Fig. 2), such that the rotation of an input shaft (34; Fig. 2), via the manual rotation of a knob (36; Fig. 2) or a motor ([0027]), causes the worm gear (40) to rotate along the ring teeth (44) and drives the rotation of the ring about a joint rotation axis (A2; Fig. 3; [0027]- [0028]) which produces a pronation or supination movement to the user’s wrist ([0038]; [0037]; [0030]).
Therefore, 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 an outer surface of Saringer’s ring (70) to have ring teeth, as taught by Bonutti above, and to modify Saringer’s locking screw (74) with the drive assembly (knob 26, input shaft 34, worm gear 40) taught by Bonutti above, such that the drive assembly (Bonutti 26, 34, and 40; Bonutti Fig. 2) is operatively coupled to the ring (70) via the connection between the worm gear (Bonutti 40) and the ring teeth (Bonutti 44 on outside surface of Saringer 70) to improve the range of motion of the user’s wrist by producing a supination movement or a pronation movement of the user’s wrist (Bonutti [0038], [0037], [0030], [0024], and last sentence of Bonutti [0026]).
Regarding claim 24, Saringer as modified teaches the invention set forth in claim 23, wherein the second force applicator (Bonutti 26, 34, and 40) configured to apply a force to the hand engagement member to manipulate the hand of the user to provide pronation or supination assistance (Bonutti [0038]; [0037]; [0030]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Celik (US 20150359697 A1): Regarding a wrist and forearm rehabilitation device that can flex a user’s lower arm about a pronation/supination axis, a flexion/extension axis, and/or an abductor/adductor axis.
Hogan et al. (US 5466213 A): Regarding a therapeutic robotic arm and system to improve the full range of motion of a patient’s limb.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 9:00 AM to 6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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