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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the wherein one end of the orthosis attachment system attaches to the load distribution device at a first location that is at least one of horizontally and vertically offset from a second location that attaches to a second end of the orthosis attachment system described in claim 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: as to claim 6, the limitations, “wherein the load distribution device is fabricated from at least one of: a substantially rigid thermoplastic, nylon, polypropylene, polyethylene, acrylonitrile butadiene styrene, polylactic acid, polyethylene terephthalate, polyethylene terephthalate glycol, and polyurethane” lacks antecedent basis for the claimed subject matter in the original filed specification.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: as to claim 9, the limitations, “wherein a surface area of the load distribution device contacting the mating body part is one of: greater than 20 cm2, greater than 50 cm2 greater than 90 cm2, greater than 100 mm2, and greater than 120 cm2” lacks antecedent basis for the claimed subject matter in the original filed specification.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: as to claim 16, the limitations, “wherein the offset attachment locations on the load distribution device impart one or more moments of rotation to the load distribution device” lacks antecedent basis for the claimed subject matter in the original filed specification.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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(s) 1-3 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. U.S. Publication No. (2012/0046585 A1) in view of Yabe et al. U.S. Publication No. (2016/0037878 A1).
With respect to claim 1), Lee et al. discloses a load distribution device or compliant anti-migration strap wrap (157, figs.11-12) for use with an orthosis (as shown in figs.1 and 9-10) and [0047] and an orthosis attachment system via straps [0051] and [0054]-[0055], wherein the orthosis attachment system via straps [0088]-[0089] is configured to attach the orthosis (as shown in figs.1 and 9-10) to a wearer of the orthosis [0009]:
wherein the load distribution device or wrap (157, figs.11-12) prevents at least one of migration of the orthosis [0091] and detrimental localized load force concentrations of the orthosis attachment system [0092; this is particularly advantageous in that the bony portions, such as the shin on the anterior side of the lower leg, have corresponding rigid or semi-rigid structure associated therewith, whereas the fleshy portion of the lower leg, such as the calf portion on the posterior side of the leg, has a substantially flexible material associated therewith allowing for muscles movement, flexibility and comfort].
wherein the load distribution device or wrap (157) comprises a degree of rigidity within the structural support body [note: since the wrap or load distribution device is being used on the anatomy of the user, inherently it imparts some degree of rigidity when placed in contact with any suitable natural or applied forces] having a curvilinear surface that is configured to approximate or match a surface of a mating body part in a first direction (as shown in fig.1 and in the reproduced image of fig.12 below, showing the first direction on the horizontal axis) and [0091, the wrap 157 defines a general shape of the lower frame element 149] and [0092, the second side 161 wraps over an exterior surface of the first side so that the wrap 157 circumferentially extends around the entirety of the lower leg of the wearer], wherein the curvilinear surface is also configured to approximate or match the surface of the mating body part in a second direction that is orthogonal to the first direction (as shown in the reproduced image of fig.12 below showing two direction one on the vertical axis); and
wherein the load distribution device or wrap (157) is connected to the orthosis attachment system or is shaped to attach to the orthosis attachment system (141 and 145, figs.9-10) and [0088]-[0089].
Lee et al. substantially discloses the invention as claimed but did not explicitly disclose the load distribution device or wrap comprises a substantially rigid structural support body.
Yabe et al. however, teaches attachment systems for attaching a wearable electronic device to a user including a sizing band and a retaining band are disclosed (abstract); wherein the bands of the attachment system can be formed from a compliant material that is configured to easily contour to a user's wrist, while retaining stiffness sufficient to maintain the position and orientation of the wearable device on the user's wrist. Suitable compliant materials may include plastic, rubber, leather, nylon, canvas or other fibrous, organic, polymeric, or synthetic materials [0054]. Note: nylon from the listing as set forth in the prior art drawn to Yabe et al. is one of the materials from which applicant’s load distribution device is made from (see claim 6), hence, would render the material substantially rigid.
In view of the teachings of Yabe et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the load distribution device of Lee et al. by incorporating a material that would render the load distribution device substantially rigid in order to maintain the position and orientation of the load distribution device on the anatomy of the user.
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With respect to claim 2), the combination of Lee et al./Yabe et al. substantially discloses the invention as claimed. Lee et al. further discloses the load distribution device or wrap (157) further applies a force in a direction to improve biomechanics of a joint of the wearer of the orthosis [0092, this is particularly advantageous in that the bony portions, such as the shin on the anterior side of the lower leg, have corresponding rigid or semi-rigid structure associated therewith, whereas the fleshy portion of the lower leg, such as the calf portion on the posterior side of the leg, has a substantially flexible material associated therewith allowing for muscles movement, flexibility and comfort].
With respect to claim 3), the combination of Lee et al./Yabe et al. substantially discloses the invention as claimed. Lee et al. further discloses the orthosis is a dynamic orthosis [0009, orthopedic braces and components for use therewith that are adjustable in both custom-fit and off-the-shelf braces so as to achieve superior functional performance characteristics while being comfortable to the wearer when worn].
With respect to claim 17), the combination of Lee et al./Yabe et al. substantially discloses the invention as claimed. Lee et al further discloses the wearer is a human [0007] and [0009].
With respect to claim 18), the combination of Lee et al/Yabe et al. inherently by virtue of the characteristic of the material property of the load distribution device or wrap, discloses the rigidity of the load distribution device is operative to transmit a tensile force of the orthosis attachment system without creating a detrimental pressure point at or near a top of the orthosis attachment system.
Claim(s) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al./Yabe et al. as applied to claim 1 above, and further in view of Zingel et al. (DE102017001596A1).
With respect to claim 4), the combination of Lee et al./Yabe et al. substantially discloses the invention as claimed except the curvilinear surface is determined based on a three-dimensional scan of the mating body part.
Zingel et al., however, teaches a support cuff as a means of treating bone and joint fractures in veterinary medicine and method of manufacture (abstract); to customize the support cuff, the following procedure is used: First, the body part data is determined by 3D scanning the negative impression with adaptive material or a nail board or a 360 degrees 3D scan. Then these data will be used to digitally adapt the support cuff. Thus, the sizes, the bends and the deformations of the support cuff are digitally determined ([Page 2], 3rd paragraph].
In view of the teachings of Zingel et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the curvilinear surface of the load distribution device of Lee et al./Yabe et al. by determining the curvilinear surface based on a three-dimensional scan of the mating body part in order to customized the curvilinear surface in order to digitally determine the sizes, the bends and the deformations of the curvilinear surface.
With respect to claim 5), the combination of Lee et al./Yabe et al./Zinger et al. substantially discloses the invention as claimed. Zinger et al. further teaches the load distribution device is made using three-dimensional ("3D") printing or additive manufacturing ([Page 2], 3rd paragraph].
With respect to claim 6), the combination of Lee et al./Yabe et al./Zinger et al. substantially discloses the invention as claimed. Zinger et al. further teaches the load distribution device is fabricated from at least one of: a rigid or semi-rigid thermoplastic (abstract).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al./Yabe et al. as applied to claim 1 above, and further in view of Cardinali U.S. Publication No. (2014/0005583 A1).
With respect to claim 7), the combination of Lee et al./Yabe et al. substantially discloses the invention as claimed except the load distribution device is fabricated using a mold of the load distribution device in order to create a cast of the load distribution device made of at least one of carbon fiber, a composite material, and fiberglass material.
Cardinali however, teaches an anti-migration pad associated with an orthopedic brace [0005] formed from a pliant material which is inherently moldable (abstract) and is fabricated from such substantially hard rigid materials as metals, plastics, fiberglass, composites or the like [0015].
In view of the teachings of Cardinali, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the load distribution device of Lee et al./Yabe et al. by fabricating the load distribution device using a mold made of fiberglass or composite materials that would render the load distribution device rigid.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Lee et al./Yabe et al.
With respect to claim 9), the combination of Lee et al./Yabe et al. substantially discloses the invention as claimed except a surface area of the load distribution device contacting the mating body part is one of: greater than 20 cm2, greater than 50 cm2 greater than 90 cm2, greater than 100 mm2, and greater than 120 cm2. However, Applicant’s invention and the prior art of record are in the same field of endeavor [the load distribution device provides anti-migration function by resisting the migration of the orthosis from the desired mounting position during use] and take into account knowledge which was within the level of ordinary skill at the time the claimed invention was made, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to optimize a surface area of the load distribution device of Lee et al./Yabe et al. having a greater than 20 cm2, greater than 50 cm2 greater than 90 cm2, greater than 100 mm2, and greater than 120 cm2 in order to accommodate different sized individuals as applicant appears to have placed no criticality on the claimed range [Note: Applicant did not provide such evidence in the original filed specification, as the claim limitations lacks antecedent basis for the claimed subject matter, see above to objection to the specification], since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al./Yabe et al. as applied to claim 1 above, and further in view of Kaphingst U.S. Publication No. (2012/0065562 A1).
With respect to claim 10), the combination of Lee et al./Yabe et al. substantially discloses the invention as claimed except a surface of the load distribution device contacting the mating body part comprises a high-friction material to minimize migration or translation between the mating body part and the load distribution device.
Kaphingst however, teaches an orthosis with limited migration (abstract) comprising a material for constructing a coupling element preferably has two properties: (1) it is elastic to enable form-fitting coupling with the protrusion on the body but at the same time to avoid pressure spots on the body; (2) it develops a high coefficient of static friction in combination with the body surface, in particular skin or skin covered with hair or fur, so that high transverse forces on the protrusion on the body can be absorbed even when the contact pressure is low to prevent migration of the orthotic. The coupling element preferably consists essentially, preferably exclusively, of an elastomer material or a composite material, in which case the material or materials are preferably selected from the group consisting of silicone elastomers [0024].
In view of the teachings of Kaphingst, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify a surface of the load distribution device of Lee et al./Yabe et al. by forming the surface having a high-friction material to minimize migration or translation between the mating body part and the load distribution device [0001] and [0014] of Kaphingst.
With respect to claim 11), the combination of Lee et al./Yabe et al./Kaphingst substantially discloses the invention as claimed. Kaphingst further teaches the high-friction material is silicone [0024, the coupling element preferably consists essentially, preferably exclusively, of an elastomer material or a composite material, in which case the material or materials are preferably selected from the group consisting of silicone elastomers].
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 15 are allowed.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The prior arts of record fail to show or make obvious the claimed combinations of elements particularly the limitations as set forth in independent claims 15 as well as dependent claim 8, in combination with the other elements (or steps) of the apparatus and method recited in the claims.
Accordingly, a prima facie case of obviousness or an anticipation rejection cannot be established with respect to the claimed subject matter as set forth in claims 8 and 15.
Response to Arguments
Applicant's arguments filed 09/29/2025 have been fully considered but they are not persuasive. Applicant argues as regard to claim 9, to expedite and streamline prosecution, Applicant has cancelled claim 9 without prejudice, however, the claims submitted on 09/29/2025, claim 9 was amended and included in the amendment to the claims and in addition, the status identifier was (Currently Amended); therefore, the objection to the specification and claim 9 has been maintained by the Office.
Applicant’s arguments, see pages 3-4, filed 09/29/2025, with respect to the rejection(s) of claim(s) 1-3 and 17 rejected under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lee et al. in view of Yabe et al. The Office maintains the teaching references to cure the deficiencies of Lee et al. in view of Yabe et al.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786