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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-12, drawn to a method of tuning an ankle foot orthosis (AFO) utilizing patient analysis, classified in A61B5/1114.
II. Claims 13-18, drawn to a kit comprising a plurality of adjustment components for tuning an ankle foot orthosis (AFO), classified in A61F5/0111.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the kit for tuning the operating characteristics of an AFO can be used in a materially different process of use such as adjusting operating characteristics of other materially different devices not limited to, but including shoes, foot prosthetics, walking boots, casts, and any other device to be worn on a user’s lower leg and foot.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Craig Lervick on 08/22/2025 a provisional election was made with traverse to prosecute the invention of group I, claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claim 13-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 plurality of heel locks as recited in claim 2 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The specification does not provide antecedent basis for the limitation of “a plurality of heel locks” found in claim 2.
Appropriate correction is required.
Claim Objections
Claims 1-12 are objected to because of the following informalities:
Claim 1 recites the limitation “Evaluating” in line 2. This limitation should be amended to be lowercase.
Claim 1 recites the limitation “a patient’s condition” in line 2. This limitation should be amended to recite “a condition of the patient” to avoid reciting “a patient” twice in the claim which may render claim 1 indefinite.
Claim 1 recites the limitation “a patient’s Shank-to-Vertical Angle (SVA)” in line 2. This limitation should be amended to recite “a shank-to-vertical angle (SVA) of the patient” to avoid reciting “a patient” twice in the claim which may render claim 1 indefinite.
Claim 1 recites the limitation “the group” in line 5. This limitation should be amended to recite “the group of tuning components comprised of” to properly present and define the Markush grouping. Examiner also recommends amending the limitation of “a second selected one of the tuning components” to also recite “a second selected tuning component from the group of tuning components” to be consistent with the first suggested amendment to avoid consistency or clarity issues.
Claim 1 recites the limitation “the selected tuning component” in line 7. This limitation, while not unclear, should be amended to recite “the at least one first tuning component” to maintain consistency in the claims.
Claim 1 recites the limitation “to achieve an SVA within the desired target range” in line 7. This limitation, while not unclear, should be amended to recite “to achieve the desired target range for the patient’s SVA” to maintain consistency in the claims.
Claims 2-12 each recite “the method of claim … wherein”. These claims should be amended to recite “The method of claim …, wherein” to include a comma to separate the preambles of the claim from the body of the claim.
Claim 5 recites the limitation “the second selected of the tuning components of the tuning components”. This limitation should be amended to remove the second recitation of “of the tuning components”.
Claim 8 recites the limitation “the second selected of the tuning components of the tuning components”. This limitation should be amended to remove the second recitation of “of the tuning components”.
Claim 11 recites the limitation “the second selected of the tuning components of the tuning components”. This limitation should be amended to remove the second recitation of “of the tuning components”.
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 1-11 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 1 recites the limitation "the desired AFO" in line 3. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the term “the desired” in claim 1 is a relative term which renders the claim indefinite. The term “desired” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The step of defining the AFO is rendered indefinite by the recitation of “desired” as to how the AFO is modified given that what may be desirable to one user, may not be desirable to another. For the purpose of examination, Examiner will interpret this limitation as “defining the AFO”.
Claim 1 recites the limitation "the group" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a group”.
Claim 1 recites the limitation "the use" in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a use”.
Claim 1 recites the limitation "the user" in line 12. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the patient”.
Claim 1 recites the limitation “using a second selected one of the tuning components”. This limitation is unclear given the earlier recitation of “at least one first tuning component” which may include a second first tuning component. Therefore it is unclear as to if Applicant is explicitly claiming an additional first tuning component, or the selection of a second different tuning component. For the purpose of examination, Examiner will interpret this limitation as “further tuning the AFO using a second tuning component selected from the group”. Examiner recommends amending claims 5, 6, 8, 9, and 11 to be consistent with the amendments made to claim 1.
Claim 2 recites the limitation “the kit further comprises” in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “wherein the group further comprises”.
Claim 3 recites the limitation “wherein selecting the at least one tuning component”. This limitation is indefinite in view of claim 1 which recites “selecting at least one first tuning component” and “using a second selected one of the tuning components” which renders claim 3 indefinite as to which selected tuning component Applicant is limiting in claim 3. For the purpose of examination, Examiner will interpret this limitation as “wherein selecting 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, 2, and 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; the foot orthosis is utilized to support a user’s foot and manipulate the joint (ankle) motion of the foot to desired biomechanical function; thus the foot orthosis provides a therapeutic effect to both the user’s foot and ankle, and is considered an ankle-foot orthosis or AFO) for a patient (see [0011] in reference to attaching wedges to the shell to correct faulty biomechanics, which is attaching wedges for tuning the AFO for a patient), comprising:
defining the desired AFO (selectively attaching the corrective wedges defines the desired AFO dependent on the biomechanical needs of the user; see [0024], [0031-0032], and [0034]; see figures 1, 7, and 8 in reference to multiple defined and desired AFO’s) and a desired target range for the patient's SVA (correction of Malaligned skeletal structures associated with faulty biomechanics includes defining a desired target range for the patient’s malaligned SVA (i.e. defining a desired alignment of the skeletal structures such that a user is able to walk smoothly and comfortably); see [0002], [0004], [0011], and [0034]);
selecting at least one first tuning component (21, 22, 24; see [0024]; see figure 1), selected from the group (20; see [0021]; see figure 1; 20 is a plurality or group of corrective tuning components) of a heel lift (24 is a heel lift; see [0024]), a medial forefoot post (22 is positioned and structured similarly to applicant’s own “forefoot post”, and thus is a medial forefoot post; see [0024]), and a lateral forefoot post (21; is positioned and structured similarly to applicant’s own “forefoot post”, and thus is a lateral forefoot post; see [0024]) setting up the AFO (foot orthosis) with the selected tuning component (21, 22, 24) to achieve an SVA within the desired target range (correcting faulty biomechanics as discussed in [0011]; see [0004] in reference to a faulty biomechanic being malaligned skeletal structures (i.e. a malaligned SVA); thus, correcting faulty biomechanics through selectively applying corrective wedges is considered to be achieving an SVA within the desired target range (i.e. a corrected alignment)); and
further tuning the AFO (foot orthosis) using a second selected one of the tuning components (25; see [0024]; see figure 1; 25 is a second heel lift).
Song does not explicitly disclose the steps of Evaluating a patient's condition and measuring a patient's Shank-to-Vertical Angle (SVA);
measuring the patient's SVA while wearing the AFO;
analyzing the use of the AFO by the patient by looking 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 user is in a terminal stance position.
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, 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 also perform the method steps as claimed to allow the 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]).
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 of evaluating a patient's condition and measuring a patient's Shank-to-Vertical Angle (SVA); measuring the patient's SVA while wearing the AFO; and analyzing the use of the AFO by looking at the multiple angles of the user’s leg when the user is in a terminal stance position, 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 as now modified discloses the invention as discussed above.
Song further discloses (see 112b interpretation above) wherein the group (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 12, Song as now modified discloses the invention as discussed above.
Song further discloses wherein the at least one first tuning component (21, 22, and 24) is a heel lift (24 is a heel lift) having a predetermined thickness and predetermined hardness (all 3-dimensional structures like 24, when formed, have a predetermined thickness and all materials have a predetermined hardness; thus 24 has a predetermined thickness and hardness) which is applied to an outer portion (15; see [0022]; see figure 1; 15 when the AFO is in use, faces away from the user and thus is an “outer portion”) of the AFO (foot orthosis; see figure 7).
Claim(s) 3-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US 2006/0059726 A1) (hereinafter Song) in view of Smirman (US 2014/0298600 A1).
In regards to claim 3, Song as now modified discloses the invention as discussed above.
Song further discloses wherein selecting the at least one tuning component (21, 22, 24) further comprises selecting from a heel lift (24 is a heel lift; see [0024]; see figure 1).
Song as now modified 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 tuning component as disclosed by Song and to have formed the tuning component from the high durometer foam as taught by Smirman in order to have provided an improved at least one 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]).
In regards to claim 4, Song as now modified by Smirman discloses the invention as discussed above.
Song further discloses wherein the at least one first tuning component (21, 22, 24) is applied to an inner portion (11; see [0022]; see figure 2; 11 when the AFO is in use, faces towards the user and thus is an “inner portion”) of the AFO (foot orthosis; see figure 2).
In regards to claim 5, Song as now modified by Smirman discloses the invention as discussed above.
Song further discloses wherein the second selected one of the tuning components (25) of the tuning components is applied to an outer portion (15; see [0022]; see figure 1; 15 when the AFO is in use, faces away from the user and thus is an “outer portion”) of the AFO (foot orthosis; see [0035] and figure 7 that 20 (and therefore 25) when desired, is selectively applied to 15).
In regards to claim 6, Song as now modified by Smirman discloses the invention as discussed above.
Song further discloses wherein the at least at least one first tuning component (21, 22, and 24) is removed before the second selected one of the tuning components (25) is utilized for tuning (see figure 7 that when 20 is applied on 15, 20 is not applied on 11; thus, the user, prior to selectively applying 20 (and therefore 25) to 15, removes 21, 22, and 24 from 11).
In regards to claim 7, Song as now modified by Smirman discloses the invention as discussed above.
Song further discloses wherein the at least one first tuning component (21, 22, 24) is applied to an outer portion (15; see [0022]; see figure 1; 15 when the AFO is in use, faces away from the user and thus is an “outer portion”) of the AFO (foot orthosis; see [0035] and figure 7 that 20 (and therefore 21, 22, and 24) when desired, is selectively applied to 15).
In regards to claim 8, Song as now modified by Smirman discloses the invention as discussed above.
Song further discloses wherein the second selected one of the tuning components (25) of the tuning components is applied to an inner portion (11; see [0022]; see figure 1; 11 when the AFO is in use, faces towards the user and thus is an “inner portion”) of the AFO (foot orthosis; see figure 2).
In regards to claim 9, Song as now modified by Smirman discloses the invention as discussed above.
Song further discloses wherein the at least at least one first tuning component (21, 22, 24) is removed before the second selected one of the tuning components (25) is utilized for tuning (see figure 7 that when 20 is applied on 15, 20 is not applied on 11; thus, the user, prior to selectively applying 20 (and therefore 25) to 11, removes 21, 22, and 24 from 15).
In regards to claim 10, Song as now modified by Smirman discloses the invention as discussed above.
Song further discloses wherein the at least one first tuning component (21, 22, and 24) is applied within a shoe of the patient (see [0036]; see figure 8).
In regards to claim 11, Song as now modified by Smirman discloses the invention as discussed above.
Song further discloses wherein the second selected one of the tuning components (25) of the tuning components is applied to an inner portion (11; see [0022]; see figure 1; 11 when the AFO is in use, faces towards the user and thus is an “inner portion”) of the AFO (foot orthosis; see figure 2 and 8).
Conclusion
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/Examiner, Art Unit 3786