DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 12/27/2023. Claims 1-17 are pending and examined below.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 4-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170027477 A1 (hereinafter referred to as “Charles”).
Regarding claim 1, Charles, a method/apparatus for generating a set of recommended orthotic product, teaches a method of providing a foot orthotic to a person in need thereof (abstract), the method including the steps of:
presenting a map of a foot and leg divided into predetermined regions to the person (“The data received by the imaging sensor may be used by a processor to generate a three-dimensional curvilinear map of the extremity of interest”; paragraph [0034]; “The processor may present a pre-written script to the user via the display to assist the consumer in orienting themselves to the capabilities of the system, and determining the realm of relevant orthotic products that the individual consumer may have a need for. For example, the consumer may be provided an interface by the processor that requests the consumer to select different areas of a skeletal mapping of a generic consumer or the individual consumer (as provided by one or more of the imaging sensors). The selected areas of the skeletal mapping may correlate to one or more extremity areas for which orthotic products are available. For example, the consumer may be prompted to select foot, knee or ankle as the extremity area of interest, and then answer certain relevant questions; such as, “How long have you had the injury?”, “Is it a recurring injury?”, “Do you have swelling?”, “What activities will you be doing while wearing a brace?”; paragraph [0040]);
receiving a selection from the person of one or more regions from the map corresponding to one or more locations where the person is experiencing pain or discomfort (paragraph [0040]);
defining a plurality of foot orthotic types, each foot orthotic type adapted to address pain or discomfort in the one or more regions where the person is experiencing pain or discomfort (paragraph [0041]; shown in Figure 1);
dispensing an orthotic from the plurality of orthotic types such that the defined orthotic is adapted to address pain or discomfort in the region where the person first experienced the pain or discomfort (paragraph [0041]; shown in Figure 1).
Regarding claim 4, Charles teaches wherein the predetermined regions of the map of the foot and leg comprise foot areas; ankle areas; and knee areas (paragraph [0040]).
Regarding claim 5, Charles teaches wherein the knee areas include lateral knee joint; patella; medial knee joint; pes anserine or intertendinous bursa; patella tendon; tibialis anterior tendon; anterior border of the tibia; and the tibia (as shown in Figure 13).
Regarding claim 6, Charles teaches wherein the ankle areas include Achilles tendon; Achilles insertion; retrocalcaneal bursa; peroneal tendon; anterior talofibula ligament; dorsal lateral midfoot; stylet process; tibialis posterior tendon; medial tubercle calcaneus; medial band plantar fascia; navicular; and first metatarsophalangeal joint (as shown in Figure 13).
Regarding claim 7, Charles teaches wherein the foot areas include first-fifth metatarsophalangeal joints; second-fifth metatarsals; navicular; mid tarsal joints; anterior ankle joint; second to fifth plantar plates; central band of the plantar fascia; central and lateral calcaneus; sesamoid; and plantar plate interdigital spaces (paragraph [0055]; as shown in Figures 11, 13).
Regarding claim 8, Charles teaches wherein a predetermined region on the map of the leg and foot includes a flat feet with no pain region (paragraph [0055]; as shown in Figures 11, 13).
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) 2-3, 9-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charles as applied to claim 1 above, and further in view of https://www.steepergroup.com/SteeperGroup/media/SteeperGroupMedia/Additional%20Downloads/Steeper-Orthotic-Solutions-Catalogue.pdf (hereinafter referred to as “Steeper Orthotic Solutions”).
Regarding claim 2, Charles does not explicitly teach wherein the defined plurality of foot orthotic types are formed from a ¾ length orthotic shell adapted to extend between the heel and to or adjacent to the metatarsophalangeal joints, the orthotic shell adapted to contour to the sole of a foot of the person.
However, Steeper Orthotic Solutions teaches an orthotic type formed from a ¾ length orthotic shell adapted to extend between the heel and to or adjacent to the metatarsophalangeal joints, the orthotic shell adapted to contour to the sole of a foot of the person (page 187). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Charles, to have a specific orthotic shell types, as taught by Steeper Orthotic Solutions, because doing so provides an effective orthotic device to account for feet discomfort.
Regarding claim 3, Charles, in view of Steeper Orthotic Solutions, teaches wherein the orthotic types comprise having one or more of the variations consisting of: 0° to 6° inversion or eversion; 3 mm to 7 mm lateral support; 2 mm to 6 mm heel raise; a plantar fascia groove having a depth from 0.25 mm to 5 mm; metatarsal dome having a height between 3 to 10 mm and a diameter of 10 to 50 mm; first ray accommodation cut-out between 30° to 90°; and styloid process accommodation of between 25 mm to 65 mm (pages 180-203).
Regarding claim 9, Charles, in view of Steeper Orthotic Solutions, teaches wherein the orthotic types include a shell in the form of:
a control being a mid-foot controlling device having a fulcrum focal about the navicular and adapted to control mid-tarsal joints (pages 180-203);
a rear control being a rear-foot controlling device having a fulcrum proximal to the talo navicular joint and adapted to control the sub-talar joint (pages 180-203);
an extended heel section adapted to reduce compression at the medial tubucle of the calcaneous and having a fulcrum at the first metatarsal cuneiform joint (pages 180-203);
a contour shell adapted to contour to the foot of a patient to maximise load distribution and being further adapted to be inverted or everted (pages 180-203).
Regarding claim 10, Charles, in view of Steeper Orthotic Solutions, teaches wherein the defined foot orthotics are selected from the group consisting of an orthotic shell having:
A. 0° contour shell, 4 mm lateral support, 3 mm Heel Raise, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
B. 6° inversion correction comfort shell, 3 mm Heel Raise, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
C. 6° inversion correction support shell, 3 mm Heel Raise, 3 mm Lateral Support, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
D. 6° inversion correction support shell, 5 mm heel Raise, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
E. 0° comfort shell, 4 mm Lateral Support, 3 mm Heel Raise, Styloid relief, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
F. 0° comfort shell, 5 mm heel Raise, 4 mm Lateral Support, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
G. 6° comfort shell, 5 mm Heel Raise, 4 mm Lateral Support, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
H. 6° support shell, 4 mm heel Raise, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
I. 5° comfort shell, 4 mm Lateral Support, 5 mm Heel Raise, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
J. 5° support shell, 3 mm Heel Raise, 4 mm Lateral Support, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
K. 4° inversion correction performance shell, 4 mm Heel Raise, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
L. 5° comfort shell, 4 mm Lateral Support, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
M. 5° comfort shell, metatarsal dome having a height between 3 to 10 mm and a diameter of 10 to 50 mm, 4 mm Lateral Support, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
N. 0° inversion or eversion contour shell, 6 mm Lateral Support, Styloid Accommodation, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
O. 6° comfort shell, 5 mm Heel Raise, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°,
P. 4° performance shell, Plantar Fascial Grove of depth between 0.75 mm to 1.5 mm, 1st Ray accommodation cutout at 45°, metatarsal dome having a height between 3 to 10 mm and a diameter of 10 to 50 mm (pages 180-203).
Regarding claim 11, Charles, in view of Steeper Orthotic Solutions, teaches wherein the defined foot orthotics are dispensed to the person dependent on the region where the person first experienced the pain or discomfort according to:
defined orthotic A in response to first pain at lateral knee joint, patella or medial knee joint, patella tendon, medial or lateral joint line/compartment genu varum;
defined orthotic B in response to first pain at the patellofemoral joint;
defined orthotic C in response to first pain at pes anserine or intertendinous bursa, patellofemoral joint valgum, patella tendon, iliotibial tract, medial or lateral joint line/compartment genu vaglum;
defined orthotic D in response to first pain at Achilles genu valgum, or anterior border of shin;
defined orthotic F in response to first pain at Achilles genu varum, Achilles tendon, Achilles insertion, or retrocalcaneal bursa;
defined orthotic G in response to a person having flat feet and no pain;
defined orthotic H in response to first pain at tibialis posterior tendon, tibialis anterior tendon, or navicular;
defined orthotic I in response to first pain at Achilles enthesopathy, or retrocalcaneal bursa;
defined orthotic K in response to first pain at first metatarsophalangeal joint, plantar plate, sesamoid, second plantar plate interdigital space, third and fourth plantar plates interdigital space, heel MTC <please note I am unsure if MTC is medial tubercle calcaneus as minimum toe clearance does not indicate the location of pain>, medial calcaneal nerve, Hallux abducto valgus, or first metatarsophalangeal joint;
defined orthotic L in response to first pain at plantar fascia length, midfoot lisfranc, second-fourth metatarsal, mid tarsal joints, medial tubercle calcaneus, or medial band plantar fascia.
defined orthotic M in response to first pain at second-fourth metatarsophalangeal joint midshaft or PL, or third or fourth toes.
defined orthotic N in response to first pain at styloid, fifth metatarsophalangeal joint, fifth plantar plate, peroneal tendon, anterior talofibula ligament, dorsal lateral midfoot, and styloid process.
defined orthotic O in response to first pain at the tibia/shin;
defined orthotic P in response to first pain at <1 cannot see a first area of pain corresponding to script 16> (page 180-203).
Regarding claim 12, Charles, in view of Steeper Orthotic Solutions, teaches further including the step of measuring or 3-D scanning the person's foot and 3-D printing a defined foot orthotic being dimensioned to correspond to the person's foot (paragraph [0034]).
Regarding claim 13, Charles, in view of Steeper Orthotic Solutions, teaches wherein the defined foot orthotic is 3D printed on a blank foot orthotic (paragraph [0034]).
Regarding claims 14 and 17, Charles, in view of Steeper Orthotic Solutions, teaches wherein the foot of the person is electronically scanned by the person or by a third party (paragraphs [0033]-[0034]).
Regarding claims 15 and 16, Charles, in view of Steeper Orthotic Solutions, teaches wherein the predetermined regions of the map of the foot and leg comprise foot areas; ankle areas; and knee areas (paragraphs [0040]-[0041]).
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791