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 .
Priority
Applicant’s claim for the benefit of a prior-filed application 63/624,343 under 35 U.S.C. 119(e), 120, 121, 365(c) or 386(c), is acknowledged.
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 2-8 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.
Claims 2-8 each recite an action directed to the insert (“is placed”, “is positioned”, “is embedded”) rendering the claim indefinite. Is it unclear if the Applicant wishes to expand the claimed invention (claim 1 and its dependents are directed to “an insert”) to include further elements, wishes to claim methods of use of the insert, or intends to claim capable uses of the insert. As it is unclear, the claims are indefinite. For the sake of compact prosecution, Examiner will interpret the locations and uses of the insert as capabilities of placement of the insert- for example in claim 2 the claim will be interpreted: wherein the insert is placeable in a stabilization boot.
Claim 4 recites the limitation "the foam insert" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the foam insert" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the foam insert" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 1-4, 7-9, 12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0221190 (“Kaiser et al”) in view of US 3,511,233 (“Holy JR”).
With respect to claim 1, Kaiser et al discloses An insert for use during orthopedic knee surgery (Fig 25, [0007], insert 290 shown at the sole, device for surgery so it can be used in knee surgery), the insert configured for positioning in or on a boot configured to stabilize a foot of the patient during orthopedic knee surgery (Fig 25, insert 290 shown at the sole can be used to stabilize a foot), the insert … including a heel region, a toe region and an arch support positioned between the toe and heel region ([0157], plantar insert 290 shown extending across the sole and can be adapted to the user so it has a heel region, toe region, and arch support), the arch support configured to support an arch of the foot of the patient during stabilization of the foot during orthopedic knee surgery thereby preventing collapse of the arch during securement of the foot in the boot ([0157], insert custom formed to the user would match the user’s foot and thus prevent collapse of the arch).
Kaiser et al is silent on the insert being sterile.
Holy JR teaches an analogous foot support and insert (Fig 1, support 14 and insert 32) further teaching the insert is sterile (col 2 ll 00-05).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kaiser et al to be sterile and sterilizable as taught by Holy in order to allow for use with multiple patients (Holy JR col 5 ll 65-70).
With respect to claim 2, Kaiser et al/Holy JR discloses The insert of claim 1 wherein the insert is placed in a stabilization boot stabilizing the foot of the patient during orthopedic knee surgery (Kaiser et al Fig 25, insert 290 shown at the sole in a boot and can be used to stabilize a foot).
With respect to claim 3, Kaiser et al/Holy JR discloses The insert of claim 1, wherein the insert is positioned on top of a foam insert positioned on the stabilization boot (Kaiser et al [0090], [0156], Fig 27, insert is outside of, and therefore on top of, the wrap 25 which is foam).
With respect to claim 4, Kaiser et al/Holy JR discloses The insert of claim 1, wherein the insert is positioned underneath the foam insert positioned on the stabilization boot (Kaiser et al [0090], [0156], Fig 27, insert is inferior to, and therefore on underneath, the wrap 25 which is foam).
With respect to claim 7, Kaiser et al/Holy JR discloses The insert of claim 1, wherein the insert is customized to accommodate the foot of the patient (Kaiser et al [0157], insert is custom formed).
With respect to claim 8, Kaiser et al/Holy JR discloses The insert of claim 1, wherein the insert is positioned in one of a left or right boot to accommodate a left or right foot of the patient accordingly (Kaiser et al Fig 27, insert shown in a boot applied to the left foot).
With respect to claim 9, Kaiser et al discloses A system for supporting a foot of the patient during surgery ([0007], used in surgery), the system comprising
a) a stabilization boot for supporting the foot of a patient (Fig 26, boot 35), the stabilization boot including a lower region to accommodate a foot of the patient and an upper region to accommodate a portion of a leg of the patient (Fig 26, upper region 125, lower region 115), the stabilization boot including a tightening mechanism to secure the leg of the patient (Fig 26, tightening system 275A);
b) a pad positioned on the boot to cushion one or both of the foot and leg of the patient (Fig 27, pad 30/25); and
c) … the arch supporting insert including an arch support region thereby preventing collapse of the arch of the patient during securement of the foot in the stabilization boot during orthopedic surgery ([0157], insert 290 custom formed to the user would match the user’s foot and thus prevent collapse of the arch).
Kaiser et al is silent on the insert being a sterile arch support insert.
Holy JR teaches an analogous foot support and insert (Fig 1, support 14 and insert 32) further teaching the insert is sterile (col 2 ll 00-05).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kaiser et al to be sterile and sterilizable as taught by Holy in order to allow for use with multiple patients (Holy JR col 5 ll 65-70).
With respect to claim 12, Kaiser et al/Holy JR discloses The system of claim 9, wherein the arch supporting insert is independent of the pad and positionable either on top of or under the pad for the orthopedic surgery (Kaiser Fig 27, insert 290 outside of and inferior to the pad 30/25 so is both on top of and under).
With respect to claim 14, Kaiser et al/Holy JR discloses The system of claim 9, wherein the orthotic is removably attached to the pad (Kaiser et al Fig 25, pad 30/25 and insert 290 are separate elements).
With respect to claim 15, Kaiser et al/Holy JR discloses The system of claim 9, wherein the pad is composed of a foam material (Kaiser et al [0090], [0101], part wrap 25 of the pad 25/30 is foam).
With respect to claim 16, Kaiser et al/Holy JR discloses A device for supporting a foot of a patient during orthopedic knee surgery ([0007], capable of use in knee surgery as it is used in other surgeries), the device … comprising a foam pad configured for placement on a foot positioning boot which stabilizes the patient's foot during orthopedic knee surgery ([0157], Fig 25, foam pad 290 of boot 35), the foam pad including a foot region, a leg region and an arch supporting region ([0157], plantar insert 290 shown extending across the sole and can be adapted to the user so it has a heel region, toe region, and arch support) to support an arch of the patient and prevent collapse of the arch during stabilization of the patient's foot during orthopedic knee surgery ([0157], insert 290 custom formed to the user would match the user’s foot and thus prevent collapse of the arch).
Kaiser et al is silent on the device being sterile
Holy JR teaches an analogous foot support and insert (Fig 1, support 14 and insert 32) further teaching the device is sterile (col 2 ll 00-05).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kaiser et al to be sterile and sterilizable as taught by Holy in order to allow for use with multiple patients (Holy JR col 5 ll 65-70).
Claims 5, 6, 10, 11, 13, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al/Holy JR as applied to claims 1, 9, and 16 above, and further in view of US 2009/0192428 (“Drennan”).
With respect to claim 5, Kaiser et al/Holy JR discloses The insert of claim 1.
Kaiser et al/Holy JR is silent on wherein the insert is embedded in the foam insert positioned on the stabilization boot.
Drennan teaches an analogous insert and foam wrap ([0025], Fig 1) wherein the insert is embedded in the foam insert positioned on the stabilization boot ([0029], embedded foot plate 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embed the insert of Kaiser et al as taught by Drennan in order to improve effectiveness and reduce costs (Drennan [0018], [0031]).
With respect to claim 6, Kaiser et al/Holy JR discloses The insert of claim 1.
Kaiser et al/Holy JR is silent on wherein the insert is integral with the foam insert positioned on the stabilization boot.
Drennan teaches an analogous insert and foam wrap ([0025], Fig 1) wherein the insert is integral with the foam insert positioned on the stabilization boot ([0029], embedded foot plate 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embed the insert of Kaiser et al as taught by Drennan in order to improve effectiveness and reduce costs (Drennan [0018], [0031]).
With respect to claim 10, Kaiser et al/Holy JR discloses The system of claim 9.
Kaiser et al/Holy JR is silent on wherein the arch supporting insert is embedded in the pad.
Drennan teaches an analogous insert and foam wrap ([0025], Fig 1) wherein the arch supporting insert is embedded in the pad ([0029], embedded foot plate 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embed the insert of Kaiser et al as taught by Drennan in order to improve effectiveness and reduce costs (Drennan [0018], [0031]).
With respect to claim 11, Kaiser et al/Holy JR discloses The system of claim 9.
Kaiser et al/Holy JR is silent on wherein the arch supporting insert is integral with the pad.
Drennan teaches an analogous insert and foam wrap ([0025], Fig 1) wherein the arch supporting insert is integral with the pad ([0029], embedded foot plate 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embed the insert of Kaiser et al as taught by Drennan in order to improve effectiveness and reduce costs (Drennan [0018], [0031]).
With respect to claim 13, Kaiser et al/Holy JR discloses The system of claim 9.
Kaiser et al/Holy JR is silent on wherein the orthotic is non-removably attached to the pad. Drennan teaches an analogous insert and foam wrap ([0025], Fig 1) on wherein the orthotic is non-removably attached to the pad ([0029], embedded foot plate 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embed the insert of Kaiser et al as taught by Drennan in order to improve effectiveness and reduce costs (Drennan [0018], [0031]).
With respect to claim 17, Kaiser et al/Holy JR discloses The device of claim 16.
Kaiser et al/Holy JR is silent on wherein the insert is embedded in the foam pad.
Drennan teaches an analogous insert and foam wrap ([0025], Fig 1) wherein the insert is embedded in the foam pad ([0029], embedded foot plate 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embed the insert of Kaiser et al as taught by Drennan in order to improve effectiveness and reduce costs (Drennan [0018], [0031]).
With respect to claim 18, Kaiser et al/Holy JR discloses The device of claim 16.
Kaiser et al/Holy JR is silent on wherein the insert is integral with the foam pad.
Drennan teaches an analogous insert and foam wrap ([0025], Fig 1) wherein the insert is integral with the foam pad ([0029], embedded foot plate 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embed the insert of Kaiser et al as taught by Drennan in order to improve effectiveness and reduce costs (Drennan [0018], [0031]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Delia US 2878493- foot support with internal padding
Cotton US 2007/0021702- leg support with foot member (Fig 8)
Gauta US 2013/0318721- foot support with padding
Grim et al US 5,329,705- insert for ankle orthosis
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM D BAKER whose telephone number is (571)270-3333. The examiner can normally be reached Monday-Friday 9:30-5:30.
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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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/ADAM BAKER/Primary Examiner, Art Unit 3786