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 flexible or semi-flexible hinge describe in claims 1 and 7 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.
Claim Objections
Claim 1 is objected to because of the following informalities: the status identifier for claim 2 has been changed to (withdrawn) however, in the election filed on 08/05/2025 claim 2 was included in the election. For the purpose of examination, the Office will consider claim 2 on the merits. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 4-5 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
As to claim 4, the limitation, “wherein the one or more tensioning element connects the proximal portion to the distal portion medially, laterally, or medially and laterally, relative the ankle of the wearer” and “wherein the one or more tensioning element is located anterior to the ankle of the wearer” positively recites part of the human body.
As to claim 5, the limitation, “wherein one or more energy storage element connects the proximal portion to the distal portion medially, laterally, or medially and laterally, relative the ankle of the wearer” and “wherein the one or more energy storage element is located posterior to the ankle of the wearer” positively recites part of the human body.
To obviate a rejection under 35 USC 101, the Office suggests that any claim that would include a human being, or part thereof, within its scope should use “configured to” or configured for” to define the metes and bounds of the claimed subject matter which is a permissible form of expression.
Allowable Subject Matter
Claims 1-3 and 6-10 are allowed.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The prior art of record fail to show or make obvious the claimed combinations of elements particularly the limitations as set forth in independent claims 1 and 7 and dependent claims 2-3, 6 and 8-10 which recite features not taught or suggested by the prior art of record which fails to disclose or fairly suggest one or more flexible or semi-flexible hinge rotatably connecting the proximal portion and the distal portion, and configured to be medially, laterally, or medially and laterally, adjacent to the ankle of the wearer, wherein the one or more tensioning element traverses from the distal portion to the proximal portion across the one or more flexible or semi-flexible hinge; and wherein the one or more tensioning element generates a rotational force between the proximal portion and around two or more axes of rotation of the flexible or semi-flexible hinge to adjust tension across multiple axes of the ankle of the wearer while the orthotic device is being worn, 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 1 and 7.
Claims 2-3, 6 and 8-10 are allowed insofar as they depend from the allowed base claims 1 and 7.
Response to Arguments
Applicant’s arguments, see pages 1-4, filed 03/10/2026, with respect to claims 1-2 and 6 rejected under 35 U.S.C. 102(a)(1) and 3-5 and 7-10 rejected under 35 U.S.C. 103 have been fully considered and are persuasive. The rejections of claims of 1, 3-10 has been withdrawn.
Claims 1-6 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph have been withdrawn in view of amendments to aforementioned claims.
The objection to claim 1 have been withdrawn in view of the amendment to claim 1.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 5712703076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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