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 .
Information Disclosure Statement
1. The information disclosure statements (IDS) submitted on 01/19/2024 and 08/26/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, this submission of the information disclosure statements is being considered by the examiner.
Response to Amendment
2. The amendment filed 08/26/2025 has been entered. Currently, claims 1,3,7-9 and 11-21 remain pending in the application. Independent claims 1, was amended by the Applicant without the addition of new matter, to include further narrowing limitations changing the scope of the claims. Additionally, claims 1, 7, 13-14 and the specification were amended to correct previous claim objections, 112(A) and 112(B) claim rejections, and specification objections previously set forth in the Non-Final Office Action mailed 06/02/2025. Also, claims 2, 4-6, and 10 were canceled and new claims 18-21 were added.
Response to Arguments
3. Applicant’s amendment to independent claim 1 is sufficient to overcome the previous 35 USC § 102 and 103 rejections recited in the Non-Final Office Action mailed 06/02/2025.
Applicant’s arguments, see Remarks on Page 9 to Page 15, filed 08/26/2025, with respect to the rejection under 35 USC § 102 and 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, the amended claims have changed the scope of the claims and upon further consideration, a new grounds of rejection is made in view of new and current prior art of the record: Bhugra et al. (U.S. Patent Pub. No. 20210106489), Yeow et al. (U.S. Patent Pub. No. 20170119614), Vogel (DE 202018106495 U1), Guo et al. (U.S. Patent Pub. No. US 20150298319).
4. Applicant makes the argument with regards to claim 9 that “Yeow specifically teaches away from cable-drive/linkage actuation in favor for pneumatic actuation, making the proposed combination contrary to the teachings of the prior art” (Remarks, Page 15, Paragraph 3).
In response to Applicant’s argument a primary reference, such as now applied Bhugra et al. (U.S. Patent Pub. No. 20210106489), that has cable-linkage actuation is still capable of being modified by Yeow to teach a concept of actuation at all five fingers. The pneumatic actuator of Yeow wouldn’t be applied to the primary reference, Bhugra, rather in combination of Bhugra in view of Yeow the cable-linkage actuator of Bhugra is at each of the fingers as taught by the five pnueamtic actuators at each of the fingers of Yeow. Therefore, Yeow is analogous secondary reference for teaching a problem of actuation at each of the five fingers, even though the actuator system is different than the claimed invention, see MPEP 2141.01(a)(i).
Claim Objections
Claim 20 is objected to because of the following informalities:
In claim 20, rephrase “a plurality of the interconnected units” to read --the plurality of interconnected units--.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7-8, and 11-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhugra et al. (U.S. Patent Pub. No. 20210106489).
Regarding claim 1, Bhugra discloses a dynamic orthosis 206 (Paragraphs 20, 134-135, 140-141, 148, 170, and Figures 2A-2B, 4A-4B, and 5E, finger orthosis 206 with intermediate flexible structure 128 attachable to at least one finger and at least one joint of that finger. The flexible structure 128 comprising a push-pull wire 126, base plate 132, and interconnected varying height baffle units 456. The wire 126 is pushed by a linear actuator 476 to flex the joint and pulled to extend the joint) attachable to a body part of a subject, the dynamic orthosis 206 including at least one flexible element 128 attachable to digital bones spanning at least one bone joint of a respective digit of the body part, the flexible element128 comprising: a base plate 132, extending between a proximal end and a distal end of the flexible element 128; a plurality of interconnected units 456 coupled to the base plate 132 and extending along a length of the flexible element 128, each interconnected unit 456 defining a height between an external side (Figure 4B and 5E, top superior side of baffle units 456) and an internal side (Figure 4B, bottom inferior side of baffle units 456 at base 132) of the flexible element 128, wherein the interconnected units 456 vary in height along at least a portion of the length of the flexible element 128; and a displaceable rod or wire 126, extending through a longitudinal opening 511 (Paragraph 148 and Figure 5E) of the interconnected units 456 along the length of the flexible element 128, such that adjacent interconnected units 128 are detached (Figures 4B and 5E, interconnected baffles 456 attached at bottom inferior base plate 132 and are free to flex at top superior side) at the external side; wherein the flexible element is configured to elastically bend between an arced configuration (Figure 2B) and a linear configuration (Figure 2A), in alignment with the joint of the digital bone; wherein a flexion or an extension of the flexible element 128 is induced by a change in length of the rod or wire 126 at the flexible element 128, and wherein when the flexible element is flexed, a distance between adjacent interconnected units 456 at the external side of the flexible element 128 increases, while remaining unchanged (Figures 4B and 5E, interconnected baffles 456 attached at bottom inferior base plate 132 doesn’t change length while baffles 456 are free to flex at top superior side to increase in length) at the internal side of the flexible element 128.
Regarding claim 7, Bhugra discloses the invention as described above and further discloses wherein the interconnected units 456 (Paragraphs 134-135, 148, and Figures 4B and 5E, baffles 456 are proximally to distally decreasing in height) decrease in height between the proximal end to the distal end of the flexible element 128.
Regarding claim 8, Bhugra discloses the invention as described above and further discloses wherein the at least one flexible element 128 (Paragraphs 20, 134-135, 148, and Figures 2A-2B, 4A-4B, and 5E) bends with the joint during bending of the digital bones.
Regarding claim 11, Bhugra discloses the invention as described above and further discloses wherein a distal end of the rod or wire 128 is attached (Paragraphs 20, 134-135, 148, and Figures 2A-2B, 4A-4B, and 5E) to the distal end of the flexible element 128.
Regarding claim 12, Bhugra discloses the invention as described above and further discloses a drive unit 124 (Paragraphs 20, 28, 134-135, 148, and Figures 2A-2B, 4A-4B, and 5Edrive unit housing 124 at proximal end to receive wire 126) attached to a proximal end of the rod or wire 126.
Regarding claim 13, Bhugra discloses the invention as described above and further discloses wherein the drive unit 124 (Paragraphs 140-141, 170 and Figures 4E, 4G and 9, housing 124 comprising load cell conductor 950 for sensing tension/compression in push-pull wire 126 and parallelogram shaped linear actuator 474 that receives wire 126 for push-pull actuation. The wire 126 is pushed by a linear actuator 476 to flex the joint and pulled to extend the joint) is configured for pushing the rod or wire to flex the flexible element.
Regarding claim 14, Bhugra discloses the invention as described above and further discloses wherein an arc length (Figures 4B and 5E, baffles 456 are free to flex at top superior side to increase in length) of the external side of the flexible element increased when the rod or wire 126 is pushed while an arc length (Figures 4B and 5E, interconnected baffles 456 attached at bottom inferior base plate 132 doesn’t change length) of the internal side of the flexible element remains unchanged.
Regarding claim 15, Bhugra discloses the invention as described above and further discloses wherein said digital bones (Paragraph 20, finger orthosis 206 with intermediate flexible structure 128 attachable to at least one finger and at least one joint of that finger which includes metacarpal and/or proximal/middle/distal phalangeal joints) include metacarpals and/or phalanges.
Regarding claim 16, Bhugra discloses the invention as described above and further discloses wherein said at least one joint (Paragraph 20, finger orthosis 206 with intermediate flexible structure 128 attachable to at least one finger and at least one joint of that finger which includes metacarpal and/or proximal/middle/distal phalangeal joints) is a metacarpophalangeal and/or proximal or distal interphalangeal joint.
Regarding claim 17, Bhugra discloses the invention as described above and further discloses a force sensor 474,950 (Paragraphs 140-141, 170 and Figures 4E, 4G and 9, housing 124 comprising load cell conductor 950 for sensing tension/compression in push-pull wire 126 and parallelogram shaped linear actuator 474 that receives wire 126 for push-pull actuation. The wire 126 is pushed by a linear actuator 476 to flex the joint and pulled to extend the joint), configured for measuring a compression or tension of of the rod or wire 126.
Regarding claim 18, Bhugra discloses the invention as described above and further discloses wherein the force sensor 474,950 (Paragraphs 140-141, 170 and Figures 4E, 4G and 9, housing 124 comprising load cell conductor 950 for sensing tension/compression in push-pull wire 126 and parallelogram shaped linear actuator 474 that receives wire 126 for push-pull actuation. The wire 126 is pushed by a linear actuator 476 to flex the joint and pulled to extend the joint)comprises: a Bowden conductor 950 , configured for measuring compression and tension forces applied to the rod or wire 126 with respect to the flexible element 128; and a parallelogram structure 474, configured to apply resistance to bending movements (Paragraph 170, Bowden conductor load cell 950 is mounted with the linear actuator 476 in the main assembly 124. Thereby, mounting at the linear actuator 476 inherently provides better resistance against off-axis forces at the load cell 950 to improve tension/compression detection accuracy than if the load cell 950 were not mounted with the linear actuator 476) in the Bowden conductor 950.4
Regarding claim 19, Bhugra discloses the invention as described above and further discloses wherein the flexible element 128 is attachable to the digital bone using at least one structure selected as a fastener132a, 132b (Paragraph 78 and Figure 1D, strap fasteners 132a,132a to attach to finger).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bhugra et al. (U.S. Patent Pub. No. 20210106489), as applied to claim 1, in view of Vogel (DE 202018106495 U1).
Regarding claim 3, Bhugra discloses the invention as described above but fails to explicitly disclose wherein each of said interconnected units is a V or U-shaped vertical column.
Vogel teaches an analogous dynamic orthosis 11 (Page 7/26, Paragraphs 2 and 7-9, and Figures 1 and 2, orthosis 11 with accordion flexing-extension 18 of MCP joints formed by U-shaped vertical column bridges 31 also having wire 37 for controlling flexion/extension in a channel of columns 31) wherein each of said analogous interconnected units 31 (Page 7/26, Paragraphs 2 and 7-9, interconnected unit 31 forms U-shaped column vertical columns extending from user’s MCP joint) is a U-shaped vertical column.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify an orientation and shape of the interconnected units of Bhugra, so that each of said interconnected units is a U-shaped vertical column, as taught by Vogel, in order to provide an improved dynamic orthosis with enhanced interconnected units forming a compressible U-shape column vertically extending from the user’s metacarpal joint for desirable flexion and extension via a spacing formed between legs of the U-shape columns (Vogel, Page 7/26, Paragraphs 2 and 7-9).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bhugra et al. (U.S. Patent Pub. No. 20210106489), as applied to claim 1, in view of Yeow et al. (U.S. Patent Pub. No. 20170119614).
Regarding claim 9, Bhugra discloses the invention as described above and further discloses “at least one flexible element 128 attachable to at least one finger” (Paragraph 20) but fails to explicitly disclose exactly five flexible elements, each attachable to digital bones spanning a different bone joint.
Yeow teaches an analogous dynamic orthosis 504 (Paragraph 47, and Figures 2 and 5, glove orthosis 504 worn on index, middle, ring little finger, and thumb having interconnected flexing elements 500 thereon that provide a compressible and expandable pleated accordion shape that spans the MCP, PIP, and DIP joints of each finger for flexion and extension) comprising five analogous flexible elements 500 (Paragraph 47, and Figures 2 and 5, flexible actuation element 500 for each of the five fingers spanning MCP, PIP, and DIP of each finger), each attachable to digital bones spanning a different bone joint.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the number of at least one flexible elements in the dynamic orthosis of Bhugra, so that there are exactly five flexible elements attachable to digital bones spanning a different bone joint, as taught by Yeow, in order to provide an improved dynamic orthosis with an enhanced number of flexible elements having a flexible element on each finger for desirable flexion and extension control facilitating movement and rehabilitee in various hand posture motions of all fingers synchronously and simultaneously (Yeow, Paragraph 47).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Bhugra et al. (U.S. Patent Pub. No. 20210106489), as applied to claim 1, in view of Guo et al. (U.S. Patent Pub. No. US 20150298319).
Regarding claim 20, Bhugra discloses the invention as described above but fails to explicitly disclose wherein the flexible element comprises a locking plate, configured to interconnect the plurality of interconnected units for limiting or reducing a bending of a portion of the flexible element.
Guo teaches an similar dynamic finger device 22 (Paragraphs 36, 49 and Figure 2D, finger device 22 with phalange linkages 36A-D forming interconnected flexible elements with elastic locking plate 69 positioned on dorsal top surface of flexible linkages 36A-D for limiting finger flexion towards palm) wherein the analogous flexible element 36A-D comprises a locking plate 69, configured to interconnect the analogous plurality the interconnected units 36A-D for limiting or reducing a bending of a portion of the analogous flexible element 36A-D.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the flexible element of Bhugra, so that the flexible element comprises a locking plate, configured to interconnect the plurality of interconnected units for limiting or reducing a bending of a portion of the flexible element, as taught by Guo, in order to provide an improved dynamic orthosis with an enhanced flexible element having interconnected units with a top plate that limits bending of the fingers towards of the palm over a certain finger joint for desirable control and actuation (Guo, Paragraph 49).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Bhugra et al. (U.S. Patent Pub. No. 20210106489).
Regarding claim 21, Bhugra discloses the invention as described above and further discloses varying height interconnected units (Paragraphs 20, 134-135, 140-141, 148, 170, and Figures 2A-2B, 4A-4B, and 5E, interconnected varying height baffle units 456).
However, Bhugra fails to explicitly disclose wherein the interconnected units comprise a height of 3-30 mm at the proximal end and a height of 3-15 mm at the distal end.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the interconnected units of Bhugra to have a height of 3-30 mm at the proximal end and a height of 3-15 mm at the distal end, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984); see MPEP 2144.04(iv)(a). In the instant case, the interconnected units of Bhugra would not operate differently with the claimed height and since the interconnected units of Bhugra are intended to have a decreasing height from a proximal to distal end the dynamic orthosis of Bhugra would function appropriately having the claimed height. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter “can” be within the claimed ranges (specification Page 6, lines 30-31).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Milo whose telephone number is (571)272-6476. The examiner can normally be reached on Mon-Fri 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached on +1(571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael Milo/
Art Unit 3786
/ALIREZA NIA/ Supervisory Patent Examiner, Art Unit 3786