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 .
Response to Amendment
Applicant’s amendments of claims 1-12 are acknowledged by the Examiner.
Applicant’s addition of new claim 19 is acknowledged by the Examiner.
Applicant’s amendments of claim 3 have overcome the previous specification and drawing objections. Therefore, the specification and drawing objections are withdrawn.
Applicant’s amendments of claims 1-12 have overcome the previous claim objections. Therefore, the claim objections are withdrawn.
Applicant’s amendments of claims 1-3 have overcome most of the claim rejections under 35 U.S.C. 112(b). The remaining claim rejections under 35 U.S.C. 112(b) are updated below.
Claims 1-19 are pending in the current Application with claims 13-18 being withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
In regards to Applicant’s arguments that the obviousness rejection is not sufficiently supported, Examiner respectfully disagrees.
In response to Applicant’s arguments that “it is clear that Song et al. is not an Ankle-Foot-Orthosis (AFO) and lacks any ability to provide ankle stabilizing support (i.e. no uprights or any other structure is provided to support, constrain or align the ankle joint)”, it is noted that the features upon which applicant relies (i.e., uprights or any other structure is provided to support, constrain or align the ankle joint) 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). Furthermore, to the extent that the foot orthosis of Song maintains a foot in a proper position, the orthosis also maintains a user’s ankle in a proper position and thus, can be considered an AFO as claimed.
In response to Applicant’s arguments that “Song et al. does not involve a measurement-driven clinical tuning methodology set forth in claim 1 which does not include SVA measurements, and instead contains only a general reference to "faulty biomechanics", "skeletal structures [which are] malaligned", "[f]aulty biomechanics of foot" and the ability to "manipulate the joint motion to desired biomechanical function". See, Song et al., [0002], [0004], [0011] and [0034]”. Examiner agrees that Song et al. does not explicitly disclose SVA measurements or the explicit analysis of the patient’s gait. However, as discussed in the previous rejection of claim 1 and will be further expanded upon in the rejection below: “if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986); MPEP 2112.02 (I). In the present case, the AFO of Song is substantially identical to the AFO as claimed, and functions s to correct a faulty biomechanic (i.e. a faulty biomechanic such as an SVA) of the user’s lower limb utilizing substantially identical tuning components required to allow a user to perform the method steps as claimed. Thus, with respect to the method steps claimed, to the extent that the AFO of Song meets the structural limitations of the AFO as claimed, it is obvious that during normal use, operation, and self-adjustment of the AFO of Song, a user will perform the claimed method steps to identify, measure, evaluate their faulty biomechanic, and selectively utilize the optional corrective wedge assembly (see [0024]) to properly assemble the AFO by themselves to fulfil their own specific needs to manipulate the joint motion to desired biomechanical function (see [0034]) as will be further discussed below.
Therefore, because the prior art device of Song et al., in its normal and usual operation of allowing a user to selectively utilize the optional corrective wedge assembly (see [0024]) to properly assemble the AFO by themselves to fulfil their own specific needs to manipulate the joint motion to desired biomechanical function (see [0034]), would necessarily perform the method claimed, the method claimed is considered to be inherent to the device of Song et al., and because Applicant has not presented persuasive arguments which evidence that the device of Song et al., in its normal and usual operation, is functionally incapable of allowing one of ordinary skill in the art from performing the method as claimed, the rejection under 35 U.S.C. 103 is maintained.
Claim Objections
Claims 1, 5-6, 8-9, and 11 are objected to because of the following informalities:
Claim 1 recites the limitation “a patient’s gait” in line 13. This limitation should be amended to recite “a gait of the patient”.
Claim 5 recites the limitation “the second selected one of the tuning components”. This limitation should be amended to recite “the second selected tuning component”.
Claim 6 recites the limitation “the second tuning component”. This limitation should be amended to recite “the second selected tuning component”.
Claim 8 recites the limitation “the second selected one of the tuning components”. This limitation should be amended to recite “the second selected tuning component”.
Claim 9 recites the limitation “the second tuning component”. This limitation should be amended to recite “the second selected tuning component”.
Claim 11 recites the limitation “the second tuning component”. This limitation should be amended to recite “the second selected tuning component”.
Appropriate correction is required.
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 2-12 and 19 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 2 recites the limitation “wherein the at least one tuning component”. This limitation renders the claim indefinite because it is unclear as to which of the “at least on first tuning component” and “the second tuning component” recited in claim 1 is being referred to in claim 2. For the purpose of examination, Examiner will interpret this limitation as “wherein the at least one first tuning component”.
Claim 3 recites the limitation “wherein selecting the at least one tuning component”. This limitation renders the claim indefinite because it is unclear as to which of the “at least on first tuning component” and “the second tuning component” recited in claim 1 is being referred to in claim 3. For the purpose of examination, Examiner will interpret this limitation as “wherein selecting the at least one first tuning component”.
Claim 19 recites the limitation “wherein the tuning component”. This limitation renders the claim indefinite because it is unclear as to which of the tuning components recited in claim 1 is being referred to in claim 19. For the purpose of examination, Examiner will interpret this limitation as “wherein the at least one first tuning component”.
Claims 4-12 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected 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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US 2006/0059726 A1) (hereinafter Song).
In regards to claim 1, Song discloses a method for tuning an AFO (foot orthosis; see [0021]; see figure 1; 21 supports a user’s foot and manipulates the joint, and is thus, considered an AFO) for a patient (see [0011]), comprising
evaluating a condition of the patient (the orthosis can be formed by the user to fulfill their own specific needs (i.e. their own faulty biomechanics; see [0034]); thus, for the user to determine their own specific needs, they would need to first evaluate their condition) and;
defining a target range for the SVA of the patient (manipulate the joint motion to desired biomechanical function (i.e. the correction of the malaligned skeletal structures; see [0034]); the desired biomechanical function (skeletal alignment) is the target range of the user’s malaligned skeletal structures to allow for the user to walk smoothly and comfortably);
selecting at least one first tuning component (a first tuning component of 20; see figure 1) from a group of tuning components (20; see [0021]; see figure 1) comprised of a heel lift (24 lifts a user’s heel and thus, is a heel lift), a medial forefoot post (22 is positioned and structured similarly to applicant’s own “forefoot post”, and thus is a medial forefoot post), and a lateral forefoot post (21 is positioned and structured similarly to applicant’s own “forefoot post”, and thus is a lateral forefoot post) and configuring the AFO (foot orthosis) with the at least one first tuning component (22) to achieve the target range for the patient’s SVA (users can assemble the shell with the corrective wedges to fulfill their own specific needs; see [0034]);
a second selected tuning component (a second tuning component of 20; see figure 1) from the group of tuning components.
Song does not explicitly disclose the steps of measuring a shank-to-vertical angle (SVA) of the patient while the patient is in a standing position;
placing the AFO on a patient’s foot and measuring the patient’s SVA while wearing the AFO;
comparing the patient’s SVA while wearing the AFO with the target SVA range and, based upon the comparison, selecting the at least one first tuning component;
analyzing a patient’s gait while using the AFO by the patient by observing at a front leg position of the patient, a front knee position of the patient, a front toe position of the patient, a front foot position of the patient, a back leg position of the patient, a back knee position of the patient, and a rear heel position of the patient, all when the patient is in a terminal stance position; and
based upon the analysis of the patient’s gait while using the AFO, further tuning the AFO by adding, removing or replacing the at least one first tuning component with a second selected tuning component from the group of tuning components.
However, it has been held that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986); MPEP 2112.02 (I). In the present case, the AFO of Song is substantially identical to the AFO as claimed, and corrects a faulty biomechanic of the user’s lower limb utilizing substantially identical tuning components required to allow a user to perform the method steps as claimed. Thus, a user when normally wearing and assembling (i.e. using and operating) the AFO of Song based on their own specific needs to allow themselves to manipulate their joint motion based on their own specific malalignment of skeletal structures to be able to walk smoothly and comfortably (see [0034]) will inherently perform the claimed steps of:
measuring a shank-to-vertical angle (SVA) of the patient while the patient is in a standing position (to determine the user’s own specific level of malalignment of their skeletal structures and what their own specific needs are);
place the AFO on a patient’s foot and measuring the patient’s SVA while wearing the AFO (to determine which corrective wedges need to be applied in order to properly use and assemble the AFO to fulfil their own specific needs);
comparing the patient’s SVA while wearing the AFO with the target SVA range and, based upon the comparison, selecting the at least one first tuning component (also to determine which corrective wedges need to be applied in order to properly use and assemble the AFO to fulfil their own specific needs);
analyzing a patient’s gait while using the AFO by the patient by observing at a front leg position of the patient, a front knee position of the patient, a front toe position of the patient, a front foot position of the patient, a back leg position of the patient, a back knee position of the patient, and a rear heel position of the patient, all when the patient is in a terminal stance position (a patient will look at, and analyze their own gait (including during a terminal stance), and all claimed positions of their leg to determine if their joint motion is performing the desired biomechanical function and allows the user to walk smoothly and comfortably); and
based upon the analysis of the patient’s gait while using the AFO, further tuning the AFO by adding, removing or replacing the at least one first tuning component with the second selected tuning component from the group of tuning components (if the patient’s gait is not performing the desired biomechanical function based on their analysis such that they are able to walk smoothly and comfortably, the user will inherently further tune the AFO by adding, removing, and replacing tuning components until their joint motion is performing the desired biomechanical function and allows the user to walk smoothly and comfortably).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date that although Song does not explicitly disclose the method steps as discussed above, because the AFO of Song is substantially identical to the AFO as claimed and corrects a faulty biomechanic of the user’s lower limb utilizing the same tuning components required to allow the user to perform the method steps as claimed, the method steps as claimed are considered to be obvious in view of Song' s AFO and corrective wedge assembly.
In regards to claim 2, Song discloses the invention as discussed above.
Song further discloses (see 112b interpretation above) wherein the at least one first tuning component (first tuning component of 20) further comprises further comprises a plurality of intrinsic heel lifts (30 of 24; see [0024]; see figure 3), a plurality of intrinsic forefoot posts (30 of 21 and 22; see [0024]; see figure 3).
In regards to claim 3, Song discloses the invention as discussed above.
Song further discloses (see 112b interpretation above) wherein selecting the at least one first tuning component (first tuning component of 20) further comprises selecting a tuning component having a predetermined thickness (see figure 1 that each tuning component of 20 has a predetermined thickness) and durometer (each tuning component of 20 is formed from a material and thus, has a predetermined durometer) to change the measured SVA (measured malalignment) by a predetermined angular amount (each tuning component is formed as a wedge and thus, changes the malalignment of the patient’s leg by an amount predetermined by the angle of the wedge).
In regards to claim 4, Song discloses the invention as discussed above.
Song further discloses wherein the at least one first tuning component (first tuning component of 20) is applied to an inner portion of the AFO (see figure 1 that 22 is applied to an inner (i.e. medial) portion of 10).
In regards to claim 5, Song discloses the invention as discussed above.
Song further discloses wherein second tuning component (second tuning component of 20) is applied to an outer portion of the AFO (see figure 1 that 21 is applied to an outer (i.e. lateral) portion of 10).
In regards to claim 6, Song discloses the invention as discussed above.
Song further discloses wherein the at least at least one first tuning component is removed prior to applying the second tuning component (as discussed above: if the patient’s gait is not performing the desired biomechanical function based on their analysis such that they are able to walk smoothly and comfortably, they will further tune the AFO by adding, removing, and replacing tuning components until their joint motion is performing the desired biomechanical function).
In regards to claim 7, Song discloses the invention as discussed above.
Song further discloses wherein the at least one first tuning component (first tuning component of 20) is applied to an outer portion of the AFO (see figure 1 that 21 is applied to an outer (i.e. lateral) portion of 10).
In regards to claim 8, Song discloses the invention as discussed above.
Song further discloses wherein second tuning component (second tuning component of 20) is applied to an inner portion of the AFO (see figure 1 that 22 is applied to an inner (i.e. medial) portion of 10).
In regards to claim 9, Song discloses the invention as discussed above.
Song further discloses wherein the at least at least one first tuning component is removed prior to applying the second tuning component (as discussed above: if the patient’s gait is not performing the desired biomechanical function based on their analysis such that they are able to walk smoothly and comfortably, they will further tune the AFO by adding, removing, and replacing tuning components until their joint motion is performing the desired biomechanical function).
In regards to claim 10, Song discloses the invention as discussed above.
Song further discloses wherein the at least one first tuning component (first tuning component of 20) is applied within a shoe of the patient (see [0036]; see figure 8).
In regards to claim 11, Song discloses the invention as discussed above.
Song further discloses wherein the second tuning component (second tuning component of 20) is applied to an inner portion of the AFO (see figure 1 that 22 is applied to an inner (i.e. medial) portion of 10).
In regards to claim 12, Song discloses the invention as discussed above.
Song further discloses wherein the at least one first tuning component (first tuning component of 20) is a heel lift (24 or 25) having a predetermined thickness (see figure 1 that 24 has a predetermined thickness) and predetermined durometer (24 is formed from a material and thus, has a predetermined durometer based on said material) to produce a targeted change in the measured SVA (measured malalignment; 24 is formed as a wedge and thus, produces a targeted change of the malalignment of the patient’s leg by an amount predetermined by the angle of the wedge).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song in view of Smirman (US 2014/0298600 A1).
In regards to claim 19, Song discloses the invention as discussed above.
Song further discloses (see 112b interpretation above) wherein the at least one first tuning component (first tuning component of 20) comprises a heel lift (24 is a heel lift; see [0024]; see figure 1).
Song does not disclose the heel lift is a ¼ inch high durometer heel lift.
However, Smirman teaches an analogous method for tuning an AFO for a patient (see [0002] boots and shoes with corrective wedges are considered equivalent to AFOs) using an analogous tuning component (30; see [0049]; see figure 9) which functions to correct a faulty biomechanic of the user’s foot and ankle (see [0002]; see figures 3a-4d, and 7a-b); the method comprising selecting the at least one tuning component (30) from a high durometer tuning component (see [0073] in reference hard or firm foams being preferable for forming 30, hard or firm foams are considered “high durometer”) for the purpose of providing a material of the tuning component which does not to deform in any appreciable manner to maintain the requisite corrective functionality of the tuning component (See [0073]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one first tuning component which is a heel lift as disclosed by Song and to have formed the at least one first tuning component which is a heel lift from the high durometer foam as taught by Smirman in order to have provided an improved at least one first tuning component that would add the benefit of providing a material of the tuning component which does not to deform in any appreciable manner to maintain the requisite corrective functionality of the tuning component (See [0073]).
Song further discloses the use of optional height adjusters (30) for adjusting a height of the at least one tuning component (see [0031]) which may form a ¼ inch heel lift as claimed, but Song as now modified by Smirman does not explicitly disclose the high-durometer heel lift is a ¼ inch heel lift.
However, Smirman further teaches the tuning component is formed with a height corresponding to the forefoot varus/valgus angle and the rearfoot varus/valgus angle to geometrically determine the overall wedge heigh or thickness (see [0050]) for the purpose of causing, when the tuning component is inserted under the user’s foot, the subtalar joint of the wearer to assume and/or maintain a neutral position (or as close to neutral as possible) (see [0049]). Thus, the height of the heel lift of Song as now modified by Smirman is considered to be a result effective variable in that changing a height or thickness of the heel lift affects the ability of the heel lift to place, and maintain the user’s foot and ankle in neutral position (or as close to neutral as possible) (see [0049]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the height or thickness of the heel lift of Song as now modified by Smirman as it involves only adjusting the dimension of a component disclosed to require adjustment (see Song [0031] and Smirman [0049-0050]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the height or thickness of the heel lift of Song as now modified by Smirman by forming the height or thickness of the heel lift as ¼ inch as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of causing, when the tuning component is inserted under the user’s foot, the subtalar joint of the wearer to assume and/or maintain a neutral position (or as close to neutral as possible) (see Smirman [0049]).
Conclusion
THIS ACTION IS MADE FINAL. 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 DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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