DETAILED ACTION
This Office action is based on the amendments and arguments filed June 4, 2026 for non-provisional application 18/178,387. Claims 1 and 10 have been amended; claims 1-21 are currently pending, wherein claims 10-20 are withdrawn from consideration.
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 . 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.
Response to Arguments
Applicant’s arguments filed June 4, 2026 have been fully considered but they are not persuasive.
Applicant’s remarks regarding the claim interpretation of the limitations “calf tightening means” and “foot tightening means” recited in claim 1 under 35 U.S.C. 112(f) are noted. However, the interpretation is maintained for the same reasons set forth in the previous Office action mailed March 5, 2026.
In response to Applicant’s argument that DiAngelo fails to teach a “distraction assembly to distract the user’s ankle joint to create spacing in the user’s ankle joint” and the distractive force assembly taught by DiAngelo is distinct from the “distraction assembly” recited in claim 1, the examiner disagrees. DiAngelo discloses “the distractive force mechanism is configured to generate a force between the foot plate and the calf sleeve acting bidirectionally across the ankle to substantially offload bodyweight of the user passing through the ankle and lower limb” [0009] and “offloading is provided by a distractive force (i.e., a force acting in the opposite direction of the body’s weight) applied between the foot and the lower leg” [0029]. In other words, while the force of the user’s body weight is directed downwardly due to gravity, the distractive force acting in the opposite direction will be directed upwardly to generate opposing forces between the foot plate (159) and the calf sleeve (110) acting bidirectionally across the user’s ankle which will offload the user’s bodyweight from the ankle. As such, the user’s body weight will be directed through the distractive force mechanism (130) rather than being applied onto the ankle joint. When the user is wearing a shoe (159), the user’s foot will be held downwardly within the shoe preventing the upward distractive force from lifting the user’s foot from the foot plate thereby pulling the user’s foot away from the user’s lower leg creating joint spacing in the user’s ankle joint. DiAngelo further teaches that the distraction assembly (130) is configured to introduce a distractive force to the dynamic ankle orthosis system (100) and multiple different configurations and combinations of elements for distractive force mechanism (130) can be used to provide this force (¶ 0041) including a ratcheting device, wherein two rods that overlap can be ratcheted to increase rod length and provide a distractive force (¶ 0052). The increase in length of the distraction assembly (130) will pull the user’s foot (secured within the shoe 159) away from the user’s lower leg (secured within the calf sleeve 110) thereby creating joint spacing in the user’s ankle joint.
In response to Applicant’s argument that DiAngelo fails to teach “a distraction force applied by the distraction assembly to vary based on the user’s state of activity but maintain the user’s foot in contact with the footplate”, the examiner disagrees. It is noted that this limitation is directed to the intended function of the device when in use, wherein a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, DiAngelo repletely describes the ankle orthosis (100) as “dynamic”, wherein the term “dynamic” is interpreted as relating to movement or change. DiAngelo further discloses that the distractive force mechanism (130) can be configured to achieve any of a variety of different load responses and to allow different ankle mobility conditions during these active loading states (¶ 0046) as well as be adjusted in length (¶ 0052) which would thereby vary the distraction force applied by the distraction assembly. Therefore, the distraction force applied by the distraction assembly is capable of being adjusted or varied to accommodate the user’s state of activity. It appears that Applicant’s argument are relying on the distraction assembly being configured to automatically vary the applied distraction force in response to the user’s state of activity; however, it is noted that these are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “calf tightening means” and “foot tightening means” in claim 1.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. In this case, the specification describes the “calf tightening mechanism” as including a continuous loop of cable that wraps around the calf cuff and terminates at a ratcheting adjuster that allows the user to selectively tighten or loosen the calf cuff (¶ 0020). The tightening mechanism may also include laces, ratcheting belts, clamps, pneumatic tubes, etc. (¶ 0021). The “foot tightening mechanism” may be similar to that described with reference to the calf tightening mechanism (¶ 0025).
If Applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, Applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over DiAngelo et al. (US 2021/0259871) in view of Grenzke et al. (US 2010/0319216).
Regarding claims 1, 4, and 5, DiAngelo discloses an ankle joint distraction device (dynamic ankle orthosis system 100) comprising:
a calf cuff (calf sleeve 110) including a calf tightening mechanism (cables 124 + tension control unit 125) to selectively secure the calf cuff (110) to a user’s calf (Figs. 1-2B; ¶ 0030 & 0039);
a foot cuff (shoe 159) capable of pulling the user’s foot away from the user’s lower leg, the foot cuff adapted to be selectively secured to the user’s foot, the foot cuff (159) including a footplate (foot plate 150/158) adapted to underlie the user’s foot, wherein the foot cuff (159) includes one or more rigid cuff sections, and wherein the foot cuff (159) is adapted to secure the user’s foot within the foot cuff (159) in all directions (Figs. 1 & 9A-10B; ¶ 0009, 0029-0030 & 0053); and
a distraction assembly (distractive force mechanism 130) having a first distal end (lower connector 133) pivotally connected to the foot cuff (159) (via a ball joint) and a second distal end (upper connector 132) fixedly connected to the calf cuff (110) (via calf ring 123), the distraction assembly (130) positioned between the foot cuff (159) and the calf cuff (110), the distraction assembly (130) to distract the user’s ankle joint thereby creating joint spacing in the user’s ankle joint, a distraction force applied by the distraction assembly (130) to vary based on the user’s state of activity but maintain the user’s foot in contact with the foot cuff (159) (Figs. 1 & 6A-6B; ¶ 0009, 00029-0030, 0040-0042, 0046, & 0052).
However, DiAngelo fails to teach that the foot cuff includes a foot tightening mechanism, a heel strap, and a bridge strap.
Grenzke discloses an analogous foot cuff (shoe 10) including a foot tightening mechanism (securing mechanism 22 including a continuous loop of cable, lace 114, that wraps around the foot cuff, shoe 10, and terminates at a ratcheting adjuster, rotary dial 110) to selectively secure the foot cuff (10) to a user’s foot, a heel strap (wide portion 86 of heel portion 38), and a bridge strap (tongue 78), wherein the foot cuff (10) is adapted to secure the user’s foot within the foot cuff (10) in all directions (Figs. 1-6; ¶ 0017, 0020, 0022, 0024, & 0026-0029).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the foot cuff of the ankle joint distraction device taught by DiAngelo to include a foot tightening mechanism, a heel strap, and a bridge strap as taught by Grenzke for the purpose of easily loosening the foot cuff for insertion of the user’s foot and tightening the foot cuff to hold the user’s foot securely in plane within the foot cuff.
Regarding claim 2, the combination of DiAngelo and Grenzke discloses the invention substantially as claimed, as described above, and DiAngelo further discloses that the calf cuff (110) includes one or more rigid cuff sections to be form-fitted to the user’s calf (Figs. 2A-4; ¶ 0031, 0033, & 0036-0038).
Regarding claims 3 and 6, the combination of DiAngelo and Grenzke discloses the invention substantially as claimed, as described above, and Grenzke further discloses that the foot tightening mechanism (22) includes a ratcheting dial (rotary dial 110) such one assigned to BOA Technology, Inc. (¶ 0027), which has been disclosed by Applicant as a suitable tensioning mechanism for ratcheting with force multiplication (specification ¶ 0034).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the calf and foot tightening mechanisms of the ankle joint distraction device taught by the combination of DiAngelo and Grenzke to each include the ratcheting dial by BOA Technology, Inc. as further taught by Grenzke which would provide for ratcheting with force multiplication for the purpose of utilizing a known commercially available tensioning mechanism for effectively tensioning the cable of the tensioning mechanism.
Regarding claim 7, the combination of DiAngelo and Grenzke discloses the invention substantially as claimed, as described above, and DiAngelo further discloses that distraction assembly (130) includes a pair of mechanisms (on either side), each with a first distal end (lower connector 133) pivotally connected to the foot cuff (159) (via a ball joint) and a second distal end (upper connector 132) fixedly connected to the calf cuff (110) (via calf ring 123), wherein the mechanisms can be linear ratchet mechanisms (¶ 0052).
Regarding claim 21, the combination of DiAngelo and Grenzke discloses the invention substantially as claimed, as described above, and DiAngelo further discloses that the distraction force applied by the distraction assembly (130) is configured to generate a force between the foot cuff (159) and the calf cuff (110) acting bidirectionally across the ankle, wherein the distraction force is a force acting in the opposite direction of the body’s weight applied between the foot and the lower leg (¶ 0009 & 0029). Since a force acting in the direction of a user’s body weight would be in a downward direction due to gravity and a force acting in the opposite direction would be in an upward direction, the distraction force provided by the distraction assembly (130) taught by DiAngelo would provide an upward force on the user’s calf via the calf cuff (110) while the user’s foot is held downward within a foot cuff (159) that would pull the user’s foot and the user’s calf away from each other.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over DiAngelo in view of Grenzke as applied to claims 1 and 7 above, and in further view of Janowski et al. (US 2003/0153910).
The combination of DiAngelo and Grenzke discloses the invention substantially as claimed, as described above, but fails to teach that each pair of linear ratchet mechanisms include a ratcheting macro-adjuster to drive movement of a movable linear rack with teeth in a singular linear direction and lock the movable linear rack in position at tooth boundaries, and a ratcheting micro-adjuster to drive movement of the moveable linear rack in the singular linear direction and lock the movable linear rack in position with a backlash between tooth boundaries.
Janowski discloses linear ratchet mechanism (pin advance assembly 32) comprising a ratcheting macro-adjuster (ratchet mechanism 34) to drive movement of a movable linear rack (shaft 46) with teeth (surfaces 44 / teeth 78) in a singular linear direction and lock the movable linear rack (46) in position at tooth boundaries (Fig. 10C; ¶ 0069), and a ratcheting micro-adjuster (fine adjust device 90) to drive movement of the moveable linear rack (46) in the singular linear direction and lock the movable linear rack (46) in position with a backlash (lever tooth 76) between tooth boundaries (Figs. 8C, 9C, & 17A; ¶ 0083-0085).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the each of the linear ratcheting mechanisms of the ankle joint distraction device taught by the combination of DiAngelo and Grenzke to include a ratcheting macro-adjuster and a ratcheting micro-adjuster as taught by Janowski for the purpose of providing a two-stage application procedure for adjusting the position of the linear ratcheting mechanisms by first providing a quick initial position using a courser movement followed by a finer adjustment to a final position.
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 Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 9/3/2026
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