DETAILED ACTION
This is a Non-Final Rejection for Application 18/783,408 filed July 24, 2024. This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Serial No. 63/529,070, filed on July 26, 2023. Claims 1-20 are currently pending.
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
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 28, 2026.
Claim Objections
Claim 4 is objected to because of the following informalities: “a distal end of the base layer” in lines 2-3 should be amended to refer to the same distal end of the base layer claimed in claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 4 and 16 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.
Claim 4 recites the limitation "the distal end of the mid layer" in line 2. There is insufficient antecedent basis for this limitation in the claim. This rejection may be overcome with language such as “a distal end of the mid layer".
Claim 16 recites the limitation " wherein the second end includes a fastener to attach to the lower leg of the patient, including at least one of an ankle, tibia, fibula, or calf of the patient". This claim is indefinite because it is unclear whether the second end is required to fasten to at least one of an ankle, tibia, fibula, or calf of the patient or if merely the lower leg is sufficient. See MPEP § 2173.05(d). The examiner will interpret the claim as only requiring the second end fastened to the lower leg of the patient and not specifically at least one of an ankle, tibia, fibula, or calf of the patient.
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.
Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0303652 (Butler).
Regarding claim 17, Butler discloses an orthotic system (Orthotics 6000, 6100, 7000, Figs. 60A-61D), comprising:
a tri-layer orthotic (Orthotic 6000 is a tri-layer orthotic, [0179].), comprising:
an upper layer having a heel portion and a front portion (Upper layer 6018 includes front upper layer portion 6020, arch upper layer portion 6022 and heel upper layer portion 6024, Fig. 60A.);
a base layer having a proximal end and a distal end (Base layer 6010 having a distal toe end 6011 and a proximal heel end 6013, Fig. 60A.); and
a mid layer configured to connect to the base layer and the upper layer and to suspend the upper layer over the base layer when connected to the base layer and the upper layer (Mid-layer portion 6014 coupled to the distal toe end 6011 of the base layer 6010 and heel upper layer portion 6024 of upper layer 6018, Fig. 60A.); and
a tuning element configured to couple to at least one of the upper layer, the base layer, or the mid layer of the tri-layer orthotic (Shim 5718, [0171], Fig. 60A.).
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(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0303652 (Butler) in view of US 8,056,262 (Lindqvist et al.).
Regarding claim 1, Butler discloses a tri-layer orthotic system (Orthotic 6000 is a tri-layer orthotic, [0179].), comprising:
an upper layer having a heel portion and a front portion (Upper layer 6018 includes front upper layer portion 6020, arch upper layer portion 6022 and heel upper layer portion 6024, Fig. 60A.);
a base layer having a proximal end and a distal end (Base layer 6010 having a distal toe end 6011 and a proximal heel end 6013, Fig. 60A.); and
a mid layer configured to connect to the base layer and the upper layer (Mid-layer portion 6014 coupled to the distal toe end 6011 of the base layer 6010 and heel upper layer portion 6024 of upper layer 6018, Fig. 60A.), and
wherein the mid layer is configured to suspend the upper layer over the base layer when the mid layer is connected to the base layer and the upper layer (Mid-layer portion 6014 is configured to suspend the upper layer 6018 over the base layer 6010, [0179].).
Butler does not disclose wherein at least one of the upper layer and the mid layer includes a first receptacle to receive and couple the upper layer to the mid layer, and wherein at least one of the base layer and the mid layer includes a second receptacle to receive and couple the base layer to the mid layer.
However, Lindqvist discloses an analogous orthotic system in the form of resilient shoe insert 11. The resilient shoe insert 11 discloses two layers, first member 12 and second member 36, wherein the first member 12 includes a receiving pocket 34; Fig. 1; Col. 3, Lns. 1-26. The receiving pocket 34 is interpreted as a receptacle and couples the two layers together.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the mid-layer portion 6014 to couple to receptacles disposed on the upper layer 6018 and the base layer 6010 of Butler as taught by Lindqvist. A skilled artisan would have been motivated to do so because Lindqvist teaches that a stiffer second member can be selected for heavier users (Col. 3, Lns. 27-49). This feature requires the second member to be replaceable which is a direct result of using the receiving pocket as a coupling mechanism. While Lindqvist does not disclose three layers, the same coupling mechanism can be used for both the upper and base layers of Butler since the receiving pocket 34 of Lindqvist is used to couple two layers together. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to foot orthotics.
Regarding claim 2, Butler in view of Lindqvist discloses the tri-layer orthotic system of claim 1, comprising: a forefoot portion opposite the heel portion, the forefoot portion comprising the front portion of the upper layer and at least a portion of one of the mid layer or the base layer, wherein the heel portion and the forefoot portion of the tri-layer orthotic system are configured to contact and support respective heel and forefoot portions of a foot of a patient through at least a portion of a gait cycle (The front portion of the upper layer 6018 and a portion of the mid-layer 6014 are interpreted as the forefront portion and is opposite the heel portion 6024, [0179], Fig. 60A. The heel portion and the forefoot portion of the tri-layer orthotic system are configured to contact and support respective heel and forefoot portions of a foot of a patient through at least a portion of a gait cycle, [0179]-[0180].).
Regarding claim 3, Butler in view of Lindqvist discloses the tri-layer orthotic system of claim 1, wherein the first receptacle includes a groove or pocket at a proximal end of the mid layer to receive the heel portion of the upper layer, and wherein the second receptacle includes a groove or pocket at or between one of a mid portion of the base layer or the distal end of the base layer to receive a distal end of the mid layer (As a result of the modification in response to claim 1, the pockets of Lindqvist are applied to modify the mid-layer portion 6014 to couple to receptacles disposed on the upper layer 6018 and the base layer 6010 of Butler which makes the first pocket at a proximal end of the mid layer to receive the heel portion of the upper layer and the second pocket at a mid-portion of the base layer to receive a distal end of the mid layer; Butler Fig. 60A.).
Regarding claim 4, Butler in view of Lindqvist discloses the tri-layer orthotic system of claim 1, wherein the second receptacle includes a groove or pocket at the distal end of the mid layer to receive a distal end of the base layer (The second receptacle is the receiving pocket of Lindqvist. The receptacle is at the distal end of the mid layer and receives the distal end of the base layer. See the modification in claim 1.).
Regarding claim 5, Butler in view of Lindqvist discloses the tri-layer orthotic system of claim 1, wherein a distal toe portion of the mid layer extends distally beyond the front portion of the upper layer (Mid-layer portion 6014 includes a distal toe portion 6015 that extends distally beyond the front portion of the upper layer, [0179], Fig. 60A.).
Regarding claim 6, Butler in view of Lindqvist discloses the tri-layer orthotic system of claim 1, wherein the distal end of the base layer extends distally beyond the front portion of the upper layer (Base layer 6010 includes a distal toe end 6011 that extends distally beyond the front portion of the upper layer, [0179], Fig. 60A.).
Regarding claim 7, Butler in view of Lindqvist discloses the tri-layer orthotic system of claim 1, wherein the tri-layer orthotic system is configured to control foot, ankle, and body biomechanics during a gait cycle (The tri-layer orthotic system is configured to control foot, ankle, and body biomechanics during a gait cycle, [0179]-[0180].).
Claim(s) 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0303652 (Butler) in view of US 2011/0009982 (King et al.).
Regarding claim 11, Butler discloses a hybrid orthotic system (Orthotics 6000, 6100, 7000, Figs. 60A-61D), comprising:
a tri-layer orthotic (Orthotic 6000 is a tri-layer orthotic, [0179].), comprising:
an upper layer having a heel portion and a front portion (Upper layer 6018 includes front upper layer portion 6020, arch upper layer portion 6022 and heel upper layer portion 6024, Fig. 60A.);
a base layer having a proximal end and a distal end (Base layer 6010 having a distal toe end 6011 and a proximal heel end 6013, Fig. 60A.); and
a mid layer configured to connect to the base layer and the upper layer and to suspend the upper layer over the base layer when connected to the base layer and the upper layer (Mid-layer portion 6014 coupled to the distal toe end 6011 of the base layer 6010 and heel upper layer portion 6024 of upper layer 6018, Fig. 60A.).
Butler does not disclose a support having a first end coupled to the upper layer of the tri-layer orthotic, a mid portion extending away from an upper surface of the upper layer, and a second end configured to couple to and secure a portion of a lower leg of a patient to the upper layer of the tri-layer orthotic.
However, King discloses an analogous orthotic system comprising a vertical support 320 and fastener 330. The vertical support 320 has a first end coupled to a cradle 310, a mid-portion extending away from the upper surface of the cradle 310, and a second end formed by the fastener 330 that is configured to couple a patient’s lower leg; Fig. 5A; [0141]-[0142].
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the upper layer 6018 of Butler to include a support having a first end coupled to the upper layer 6018, a mid-portion, and a second end configured to couple a patient’s lower leg as taught by King. A skilled artisan would have been motivated to do so because King teaches that the vertical support 320 assists in the securing of the brace portion of the orthosis above the ankle of a user which can assist in harnessing more torque from the distal portion of the spring plate 100 ([0141]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to foot orthotics.
Regarding claim 12, Butler in view of King discloses the hybrid orthotic system of claim 11, wherein one of a distal toe portion of the mid layer extends distally beyond the front portion of the upper layer or the distal end of the base layer extends distally beyond the front portion of the upper layer (Mid-layer portion 6014 includes a distal toe portion 6015 that extends distally beyond the front portion of the upper layer, [0179], Fig. 60A.).
Regarding claim 13, Butler in view of King discloses the hybrid orthotic system of claim 11, wherein the support comprises an upper portion of an ankle-foot orthosis (AFO) coupled to the upper layer of the tri-layer orthotic system (The vertical support 320 comprises an upper portion of an ankle-foot orthosis (AFO) and is coupled to the upper layer of the tri-layer orthotic system; King [0141].).
Regarding claim 14, Butler in view of King discloses the hybrid orthotic system of claim 11, wherein the first end of the support is configured to couple to the heel portion of the upper layer (The vertical support 320, as shown in FIG. 5A, extends vertically upward from the proximal end 312 of the cradle 310; King [0141].).
Regarding claim 15, Butler in view of King discloses the hybrid orthotic system of claim 11, wherein the first end of the support is configured to couple to a medial or lateral side of a mid portion of the upper layer (The vertical support 320, as shown in FIG. 5A, extends vertically upward from the proximal end 312 of the cradle 310, and is designed to be placed adjacent to the rearward side of a subject's leg when the ankle-foot orthosis is worn; King [0141].).
Regarding claim 16, Butler in view of King discloses the hybrid orthotic system of claim 11, wherein the second end includes a fastener to attach to the lower leg of the patient, including at least one of an ankle, tibia, fibula, or calf of the patient (Fastener 330; [0141]-[0142]; Fig. 5A.).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0303652 (Butler) in view of US 2021/0015209 (Buck).
Regarding claim 18, Butler discloses the orthotic system of claim 17.
Butler does not disclose wherein the tuning element comprises a groove configured to engage at least one of the upper layer, the base layer, or the mid layer of the tri-layer orthotic.
However, Buck discloses an analogous foot orthotic comprising a sole spring insert 90 with a key member 92. The sole spring insert 90 is a tuning element and the key member 92 forms a groove that is configured to engage the sole of the orthotic in keyway 134.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the shim of Butler to include a key member configured to engage a layer of Butler that is modified to comprise a corresponding keyway 134 taught by Buck. A skilled artisan would have been motivated to do so because Buck teaches that the key member 92 and keyway 134 prevent the spring insert 90 from moving in a lengthwise direction E5 out of the cavity 14A ([0053]) while allowing the insert 90 to be replaceable. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to foot orthotics with inserts.
Regarding claim 19, Butler discloses the orthotic system of claim 17.
Butler does not disclose wherein the tuning element comprises an insert configured to couple to a receptacle on at least one of the upper layer, the base layer, or the mid layer of the tri-layer orthotic.
However, Buck discloses an analogous foot orthotic comprising a sole spring insert 90 with a key member 92. The sole spring insert 90 is a tuning element and the key member 92 is an insert that is configured to engage the sole of the orthotic in keyway 134 which is a receptacle.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the shim of Butler to include a key member configured to engage a layer of Butler that is modified to comprise a corresponding keyway 134 taught by Buck. A skilled artisan would have been motivated to do so because Buck teaches that the key member 92 and keyway 134 prevent the spring insert 90 from moving in a lengthwise direction E5 out of the cavity 14A ([0053]) while allowing the insert 90 to be replaceable. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to foot orthotics with inserts.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0303652 (Butler) in view of US 2021/0015209 (Buck), and further in view of US 5,320,223 (Allen) and US 2022/0151812 (Gunnsteinsson et al.).
Regarding claim 20, Butler in view of Buck discloses the orthotic system of claim 19.
Butler in view of Buck does not disclose a tray for holding the tuning element prior to coupling the tuning element to at least one of the upper layer, the base layer, or the mid layer, wherein the tray includes a groove to hold a plurality of different configurable tuning elements, wherein an inner profile of the groove matches an inner profile of the receptacle on at least one of the upper layer, the base layer, or the mid layer of the tri-layer orthotic, wherein the tuning element is labeled with an identifier, and wherein the tri-layer orthotic comprises a corresponding label at the receptacle configured to receive the tuning element labeled with the identifier.
However, Allen discloses an insert 14 for a tool box comprising a lower layer 20, a film 26 and an upper layer 22, which is interpreted as a tray; Fig. 4. Allen is analogous art as it is reasonably pertinent to the problem faced by the inventor of storing and organizing items while the items are not in use. The insert 14 includes cut out portions 24 which are cut in the shape of the silhouette of the item to be retained therein; Col. 2, Lns. 33-46. The cut out portions 24 are interpreted as a groove that is capable of holding a plurality of different configurable tuning elements. Additionally, the film 26 includes a label provided at the bottom of each pocket, which is interpreted as an identifier.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to include an insert 14 for storing items as taught by Allen with the tri-layer orthotic of Butler. It would further be obvious for the insert 14 to be modified to store the tuning elements of Butler and Buck. As a result, the cut out portions match an inner profile of the receptacle since the cut out portions are a silhouette of the tuning elements. A skilled artisan would have been motivated to do so because Allen teaches that the insert allows for the storage and organization of a plurality of uniquely shaped items (Col. 2, Lns. 33-68). A skilled artisan would have a reasonable expectation of success given that Allen is pertinent to the problem faced by the inventor of storing and organizing items while the items are not in use.
Butler in view of Buck and Allen, as modified above, still does not disclose wherein the tuning element is labeled with an identifier.
However, Gunnsteinsson discloses an analogous orthotic comprising a heel wedge made up of a plurality of layers which are labelled by an indicia 326 to indicate the angle or relative height provided by the heel wedge 300; Fig. 10; [0125]. The layers of the heel wedge are interpreted as tuning elements and the indicia is interpreted as an identifier.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the shim of Butler to include an indicia as taught by Gunnsteinsson. A skilled artisan would have been motivated to do so because Gunnsteinsson teaches that the indicia indicates the angle or relative height provided by the heel wedge 300. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn foot orthotics and tuning elements. The identifier in the tray of Allen can then correspond to the indicia of the tuning element for storage and organization.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 9,943,133. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of U.S. Patent No. 9,943,133 claims all of the limitations claim 17 except for a tuning element, however claim 3 claims a shim which is interpreted as a tuning element.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 10,477,917. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of U.S. Patent No. 10,477,917 claims all of the limitations claim 17 except for a tuning element, however claim 3 claims a shim which is interpreted as a tuning element.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 11,528,957. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of U.S. Patent No. 11,528,957 claims all of the limitations claim 17 except for a tuning element, however claim 5 claims a shim which is interpreted as a tuning element.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 12,004,598. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of U.S. Patent No. 12,004,598 claims all of the limitations claim 17 except for a tuning element, however claim 5 claims a shim which is interpreted as a tuning element.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 11,528,956. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of U.S. Patent No. 11,528,956 claims all of the limitations claim 17 except for a tuning element, however claim 5 claims a shim which is interpreted as a tuning element.
Conclusion
The following prior art made of record and not relied upon are considered pertinent to
applicant's disclosure.
US 4,260,978 (Simpkins)
US 4,354,124 (Schnell)
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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