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 .
Election/Restrictions
Applicant's election with traverse of Species B (Fig. 4A-4C) and claims 1-20 in the reply filed on 12/22/2025 is acknowledged. The traversal is on the ground(s) that proper serious burden was not provided and that because none of the pending claims is withdrawn then serious burden is not present. This is not found persuasive because these arguments appear to be procedural without actually presenting substantive arguments to the restriction itself.
Firstly, Examiner’s recitation of serious burden in the previous action “these three species provide distinct mutually exclusive embodiments thus providing a search and examination burden” implicitly provides further that different fields of search would be required according to MPEP 808.02, wherein mutually exclusive features would require different text search queries when searching the application as each of the features would be found within different prior art considering they have been deemed to be exclusive alternates. However, for completeness of record, Examiner provides that there is serious search burden as -- the inventions of Species A, B, and C require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries) -- being employing varying search strategies in order to find mutually exclusive features.
Secondly, in regards to the lack of claims being withdrawn being evidence of lack of serious burden, Examiner reminds Applicant that restriction practice is on the disclosure as a whole and not just the claims. The withdrawal or not of currently presented claims is not indicative of proper or improper restriction requirement, nor indicative of a lack of serious burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-9 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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 12/22/2025. Fig. 4A-4C fails to show how the free ends of the calf strap are attaching to the sock according to claim 8, and further fails to show the free ends of the calf strap attaching to itself according to claim 9. Instant specification [0066] which discusses the free ends of Fig. 4A-4C in the slots of the tensioning structure does not provide disclosure to how the free ends attach to the sock or itself. Instant paragraphs [0015-0016] provide basis for the claim language but only recite being in “yet another embodiment” wherein it is unclear if this is discussing the calf straps 102 in Fig. 1A-1C or the calf strap 142 of Fig. 4A-4C. As such, claims 8-9 are withdrawn.
Claim 12 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, with claims 13-18 being withdrawn as dependent claims, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/22/2025. Claim 12 recites “wherein each of the pair of calf anchors comprises a width and the cable is routed through the width of each of the pair of calf anchors before being secured to itself”, wherein the only recitation of the cable securing to itself is in instant paragraph [0019] within the Summary of the disclosure. Paragraph [0019] recites “In yet another variant, each of the pair of calf anchors comprises a width and the cable is routed through the width of each of the pair of calf anchors before being secured to itself”, wherein the “in yet another embodiment” makes it unclear to which embodiment it pertains. Furthermore, the actual disclosure of elected Fig. 4A-4C recites in paragraph [0077] “the cable (or strap) 114 can be routed and secured to a larger piece of fabric (e.g., calf anchor 124)” wherein it appears in the elected species the cable secures to the calf anchor and not the cable “itself”. Furthermore, the actual Figures 4A-4C does not appear to show the cable securing to itself. As such, claim 12 is found to be drawn to an unelected species and claim 12 is withdrawn. Claims 13-18 withdrawn as being dependent on a withdrawn claim.
Status of Claims
Claim(s) 1-20 is/are pending of which Claim(s) 1 is/are presented in independent form.
Claims 8-9, 12-18 withdrawn. Claims 1-7, 10-11, 19-20 examined.
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 “pull tabs that are positioned posterior from the pair of foot anchors, the pull tabs being configured to assist with donning and/or doffing of the AFO” (claim 19, pull tabs 172 not shown), “a portion of the tensioning structure is disposed between the first outer layer of sock and the second inner layer of sock and another portion of the tensioning structure is not covered by the first outer layer of sock” (claim 20, figures do not show what portions would be disposed between the layers and what portions would not be), “wherein each of the pair of calf anchors comprises a width and the cable is routed through the width of each of the pair of calf anchors before being secured to itself” (claim 12, Fig. 4C fails to show if the cable is securing to itself) 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 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 limitation(s) uses 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 limitation(s) is/are: “tensioning structure” (based on Fig. 4A-4C, the tensioning structure 122 is an area of material with the rotary knob 106 disposed thereon with a cable attached therein, Fig. 4A appears to be showing the tensioning structure 122 able to be a portion of the sock itself) and “rotary tensioning mechanism” (based on Fig. 4A-4C, may be the rotary knob 106, or according further to [0049] may be any structure that enables a cable to be routed therethrough) in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/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 limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-7, 10-11, and 19-20 are 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.
Regarding claim 1, claim 1 recites “the cable being routed through the achilles anchor, the dorsal anchor, the pair of calf anchors and secured to the pair of calf anchors”, wherein the pair of calf anchors is repeated twice wherein it is unclear if the cable is both routed through the calf anchors and then secured, or if this is actually a typo as the cable being routed through the “foot anchors” and then secured to the calf anchors. Based on further dependent claims also routing the cable through the foot anchors the Examiner will interpret this as “the cable being routed through the achilles anchor, the dorsal anchor, the pair of foot anchors and secured to the pair of calf anchors”.
Regarding claim 10, claim 10 recites “a lower portion of the tensioning structure is not secured to the sock”; however, based on Fig. 4A-4C as the upper portion of the tensioning structure is secured then the lower portion is secured to the sock via its other integral half being secured. The scope of claim 10 is unclear on how the lower portion of the tensioning structure is not secured.
Claims 2-7, 11, and 19-20 are rejected as being dependent on a reject claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 10-11, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 20240000596 A1) in view of McDonnell (US 20170172782 A1).
Regarding claim 1, Johnson discloses an ankle foot orthosis (AFO) 21 (Fig. 5A), comprising:
a sock 6 that is configured to fit over a calf muscle on a leg of a user (Fig. 5A and [0088] sock 6 wherein sock 6 is capable of fitting a lower portion of calf muscle of a user); and
a lifting cable system 12 that is at least partially integrated within the sock 6 (Fig. 5A, [0095] lifting cable system 12 is incorporated into the sock 6) comprising:
a tensioning structure 7 (Fig. 5A, cuff 7 [0088]) disposed on an upper region of the sock 6 (Fig. 5A, disposed at a top end of the sock 6),
the tensioning structure 7 comprising a rotary tensioning mechanism 1 ([0095] rotary dial) disposed thereon (Fig. 5A);
an achilles anchor that is configured to be positioned below the tensioning structure 7 on posterior portion of the sock 6 (See Annotated Fig. 5A for indicated achilles anchor on a posterior half of the sock);
a dorsal anchor that is configured to be positioned anterior to the achilles anchor (See Annotated Fig. 5A, wherein the dorsal anchor is indicated and positioned anterior to the achilles anchor);
a pair of foot anchors being positioned anterior to the dorsal anchor (See Annotated Fig. 5A, wherein a foot anchor is indicated, and see [0095] wherein the shown web 12 of Fig. 5A is on both lateral and medial sides thus there being at least two foot anchors being a pair therein);
a cable 3 that is attached with the rotary tensioning mechanism 1 (see Fig. 5A, [0094] wherein the cable can be seen going from the dial 1 into the web 12),
the cable 3 being routed through the achilles anchor, the dorsal anchor, the pair of foot anchors (See Annotated Fig. 5A and [0094-0095]).
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Johnson does not disclose a calf strap that is configured to be positioned above the calf muscle of the user when disposed on the leg of the user; a pair of calf anchors that are positioned on an upper posterior portion of the sock; the cable being secured to the pair of calf anchors.
However, McDonnell teaches an analogous ankle orthosis device 10 (Fig. 1), for analogously helping a user with drop foot (see [0003]) wherein Johnson further provides an analogous cable 54 (Fig. 1) that connects at an analogous pair of foot anchors 40 (Fig. 1) that routes to an analogous achilles anchor 56 and then connects to analogous pairs of calf anchors 16 (Fig. 1 plural anchor points built into the calf piece 16 for receiving the cable) that are positioned on an upper posterior portion of the analogous sock 20 (Fig. 1, see [0028], being a “leg holder 20” which is of similar function to a sock, see Fig. 1, being at the upper posterior portion of 20), further providing a calf strap 29 that is configured to be positioned above the calf muscle of the user when disposed on the leg of the user (Fig. 5) for securing the calf anchors to the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the calf strap 29 that is configured to be positioned above the calf muscle of the user when disposed on the leg of the user; a pair of calf anchors 16 that are positioned on an upper posterior portion of the sock; the cable 54 being secured to the pair of calf anchors as taught by McDonnell above to the invention of Johnson in order to enable more support assistance along the calf muscle of the user (Fig. 5 of McDonnell).
Regarding claim 2, Johnson in view of McDonnell teaches the invention of claim 1 above.
Johnson further discloses wherein the sock 6 comprises a first outer layer of sock 6 (Fig. 5A, the first outer layer being the outer surface of the sock 6 therein) and a second inner layer of sock 6 (Fig. 5A, the second inner layer being the inner surface of the sock 6 therein),
wherein the achilles anchor, the dorsal anchor, and the pair of foot anchors (Annotated Fig. 5A) are positioned between the first outer layer of sock and the second inner layer of sock (see [0095] wherein the web 12 being the various anchors runs through channels within the sock 6, thus being between the outer and inner surfaces and thus layers of the sock).
Regarding claim 3, Johnson in view of McDonnell teaches the invention of claim 2 above.
Johnson further discloses a toe box (Annotated Fig. 5A) positioned anterior to the dorsal anchor on the sock 6 (Fig. 5A), the toe box being configured to receive toes of the user while wearing the AFO (Fig. 5A, the toe box receives the toes of the user when wearing the sock 6, the toe box may be called the area of the inner surface of the sock 6).
Regarding claim 10, Johnson in view of McDonnell teaches the invention of claim 2 above.
Johnson further discloses wherein an upper portion of the tensioning structure 7 is attached to the upper region of the sock 6 and a lower portion of the tensioning structure is not secured to the sock (See Fig 8 and [0121] wherein the cuff 7 may be opened/unwrapped according to have hook and loop attachments for wrapping around the foot a user such that the inner portion of cuff 7 may be termed an “upper portion”, and the outer portion of the cuff 7 being a lower portion, such that as seen only the inner/upper portion is attached to the sock 6 with the outer/lower portion not being directly secured to the sock 6).
Regarding claim 11, Johnson in view of McDonnell teaches the invention of claim 2 above.
Johnson further discloses wherein the rotary tensioning mechanism 1 is secured to the lower portion (outer portion) of the tensioning structure 7 (Fig. 5A, dial 1 secured to the outer portion being a lower portion).
Regarding claim 19, Johnson in view of McDonnell teaches the invention of claim 2 above.
Johnson further discloses pull tabs 8 that are positioned posterior from the pair of foot anchors (Fig. 8 and Annotated Fig. 5A), the pull tabs 8 being configured to assist with donning and/or doffing of the AFO (see [0121] and Fig. 8 wherein each of the sock 6 and cuff 7 may contain an opening 8 forming of hook and loop for aiding in taking on and off the sock and cuff, wherein as seen in Fig. 8 the opening will form tab like structure, and based on Fig. 5A and Fig. 8 together the tabs formed in both extend posteriorly such that the sock tab 8 may have a portion posterior the foot anchor, and the cuff tab 8 is fully posterior where the foot anchor is).
Regarding claim 20, Johnson in view of McDonnell teaches the invention of claim 2 above.
Johnson further discloses wherein a portion of the tensioning structure 7 is disposed between the first outer layer of sock and the second inner layer of sock and another portion of the tensioning structure 7 is not covered by the first outer layer of sock (See Fig. 5A, wherein for claim interpretation purposes as the tensioning structure 7 comprises the rotary tensioning mechanism which is attached to the cable, the cable based on the language herein is a “portion” of the tensioning structure 7, thus as seen in Fig. 5A the cable has a portion not covered by the outer layer of sock, and the cable is also disposed between the inner and outer layers when in the web 12).
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 20240000596 A1) in view of McDonnell (US 20170172782 A1), in further view of Applegate (US 4166460 A).
Regarding claim 4, Johnson in view of McDonnell teaches the invention of claim 3 above.
Johnson in view of McDonnell does not disclose wherein the toe box possesses more elasticity in a circumferential direction around the sock as compared with elasticity in a longitudinal direction, the longitudinal direction generally running from a toe region of the sock toward the dorsal anchor, the circumferential direction being orthogonal with the longitudinal direction.
However, Applegate teaches an analogous foot sock 12 (Fig. 2) having an analogous toe box (Fig. 2, sock front opening able to receive toes of the user), wherein the toe box possesses more elasticity in a circumferential direction around the sock 12 as compared with elasticity in a longitudinal direction, the longitudinal direction generally running from a toe region of the sock toward the dorsal area, the circumferential direction being orthogonal with the longitudinal direction (Col. 2 lines 36-51 and Fig. 2, the sock is elastic and has stretchability only in the circumferential direction 18 as seen in Fig. 2, thus having more elasticity is a circumferential direction compared to a longitudinal direction being the direction from the toe to the back of the foot).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the sock/toe box elasticity of Applegate to the sock 6 of Johnson as combined in order to provide more lateral support and comfort to the wearer (Applegate Col. 2 lines 36-51).
Regarding claim 5, Johnson in view of McDonnell and Applegate teaches the invention of claim 4 above.
Johnson further discloses wherein the pair of foot anchors (Annotated Fig. 5A of Johnson) wrap around a foot region of the sock such that portions of the pair of foot anchors reside on both a top region of the sock and a bottom region of the sock (Annotated Fig. 5A, the indicated foot anchors extend from a top region of the sock to a bottom region while wrapping around a foot of the user).
Regarding claim 6, Johnson in view of McDonnell and Applegate teaches the invention of claim 4 above.
Johnson further discloses wherein the pair of foot anchors are disposed between the first outer layer of sock and the toe box (Annotated Fig. 5A and [0095] wherein the web 12 being the various anchors including the foot anchors runs through channels within the sock 6, thus being between the outer and inner surfaces and thus layers of the sock, wherein Examiner has interpreted the toe box to be the region of inner surface at the anterior half of the sock 6 past the indicated dorsal anchor, thus the foot anchors being disposed between the first outer layer of sock and the toe box).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 20240000596 A1) in view of McDonnell (US 20170172782 A1), in further view of Siller (DE 102013002466 B3) (see attached translation).
Regarding claim 7, Johnson in view of McDonnell teaches the invention of claim 2 above.
Johnson in view of McDonnell does not disclose wherein the calf strap comprises a first end and a second end, wherein the first end and the second end of the calf strap are each configured to be received within respective slots located on the tensioning structure.
Johnson does disclose the tensioning structure 7 (cuff 7) may be connected at the calf (see [0084]), thus capable of being connected with the calf strap of McDonnell.
However, Siller teaches an analogous ankle orthotic (Fig. 1-4), having an analogous tensioning structure 6 (plastic shell 6, [0045], having analogous tensioning elements 10, spring wires 10, [0045, 0035]), wherein there is an analogous calf strap 14 having first and second ends (Fig. 1-2), wherein there are slots 13 in the tensioning structure 6, wherein the first end and the second end of the calf strap 14 are each configured to be received within respective slots 13 located on the tensioning structure 6 (Fig. 1-4, [0028, 0045]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the tensioning structure 7 of Johnson with slots 13 as taught by Siller to receive first and second ends of a calf strap in order to provide an alternate known construction of securing the tensioning structure to a human body (Siller [0028, 0046], Fig. 1-4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wacker (DE 102018006519 A1) has a cable route between various anchors
Moon (WO 2019160314 A1) sock AFO with cable and rotary tensioning mechanism
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael 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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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786