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 .
Information Disclosure Statement
The information disclosure statement filed September 3, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the crossed-out reference seems to have an incorrect patent number. It has been placed in the application file, but the information referred to therein in the crossed-out reference has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings are objected to because figure 1D has two separate figures and they are not each individually labeled. 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.
Claim Objections
Claim 9 is objected to because of the following informalities: “wherein a distance between the occlusal portion and the gingival portion in the pre-mounting stat is smaller than after fitting around the orthodontic bracket” is believed to be in error for -wherein the ligature is configured such that a distance between the occlusal portion and the gingival portion in the pre-mounting stat is smaller than after fitting around the orthodontic bracket. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The limitation “wherein the superelastic metallic is nitinol” is believed to be in error for -wherein the superelastic material is nitinol-. Appropriate correction is required.
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.
Claim(s) 1-2, 4, 7-13, 15-16, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (4,725,229).
Miller discloses with respect to claim 1, a ligature 16 made of superelastic material (see abstract, fig. 12), and configured to be fitted around an orthodontic bracket (see figs. 10-11, col. 3, ll. 48-61), wherein the ligature forms a closed loop (see fig. 12, col. 3, ll. 63-64) configured to fit around the orthodontic bracket and be retained around the orthodontic bracket based on a superelastic effect of the material of the ligature (col. 3, ll. 58-61, col. 4, ll. 25-32, claim 1, such that the loop is stretched over the bracket and the superelastic properties of the material of the loop will attempt to return to its original shape once the force to stretch the loop is removed and exert a force on the bracket). With respect to all the claims, it is noted that all the limitations with respect to how the loop is retained on the bracket and how the shape/size of the ligature changes between a pre-mounted and a mounted configuration are functional. It is noted that if the structure of the prior art is capable of functioning as claimed, then the claimed limitations are met. It is noted that the orthodontic bracket is NOT being claimed, only that the loop that is capable of being retained around a bracket and configured to interact with the bracket as claimed. Therefore, the prior art only needs to teach the loop capable of functioning as claimed in order to meet the claimed limitations.
Miller further discloses with respect to claim 2, prior to fitting around the orthodontic bracket, a curvature along an occlusal-gingival direction (see annotated figure below). It is noted that fig. 12 shows the ligature before it is placed on the bracket and moving in/along an occlusal-gingival direction the ligature has a curve.
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Miller further discloses with respect to claim 4, the ligature comprising an occlusal portion configured to be arranged at an occlusal side of the bracket, a gingival portion configured to be arranged at a gingival side of the bracket, a mesial portion configured to be arranged at a mesial side of the bracket, and a distal position configured to be arranged as a distal side of the bracket (see annotated figure above, such that the ligature is capable of being placed and arranged in the mouth so that the sides are orientated in the desired directions).
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Miller further discloses with respect to claim 7, wherein the ligature is configured such that in a pre-mounting state, a perimeter of the loop is the same as the perimeter of the loop after fitting around the orthodontic bracket, and wherein in the pre-mounting state, a distance between the occlusal portion and the gingival portion and/or a distance between the mesial portion and the distal portion is different than after fitting around the orthodontic bracket. It is noted that the limitations of claim 7 are functional such that the structure of the prior art is configured to function as claimed. It is noted that apparatus disclosed by Miller is the same as what is claimed, such as a closed loop made out of a superelastic material. Therefore, since the loop is a closed loop the perimeter would be the same in both positions, as it is a continuous perimeter around the ligature. Further depending on the shape and/or size of the bracket that the ligature is mounted on and further the orientation of the ligature when placed on the bracket, the ligature would have a different distance between the occlusal portion and the gingival portion and/or a distance between the mesial portion and the distal portion then when in the pre-mounted state. Such that the ligature is configured to be stretched over a bracket to be retained thereon. Depending on the size of the bracket, the ligature may be stretched and not able to return to it memorized shape due to the bracket impeding the ligature, make the distance in either or both claimed directions to be different in that it would be greater than in the pre-mounted state. It is noted that the ligature is configured to function in a variety of ways as later claimed and discussed in detail. The above explanation is just one example of how it is configured to function as claimed.
Miller further discloses with respect to claim 8, wherein the ligature is configured such that in a pre-mounting state the mesial and distal portion have more curvature than after fitting around the orthodontic bracket. Such that the ligature disclosed by Miller is capable of functioning as claimed. As discussed above, depending on the size and/or shape of the bracket in relation to the ligature, when the ligature is fitted on the bracket is capable of having a shape with less curvature in the mesial and distal portions then when in the pre-mounted positions. Such that when the ligature is placed on the bracket, it may be stretched in the occlusal gingival direction, resulting in elongation of the mesial and distal portions, which would reduce the curvatures in the mesial and distal portions. Such that the bracket would prevent the ligature to returning to its pre-mounted shape.
Miller further discloses with respect to claim 9, wherein the ligature is configured such that a distance between the occlusal portion and the gingival portion in the pre-mounting state is smaller than after fitting around the orthodontic bracket. Such that when the ligature is placed on the bracket, depending on the size and/or shape of the bracket relative to the ligature, the distance would be as claimed. For example the distance of the bracket in the occlusal and gingival direction is greater than the distance between the occlusal and gingival portions of the ligature so that when the ligature is placed on the bracket and stretched, the ligature would not be able to fully return to its original shape, including the distance between the occlusal and gingival portions as the bracket would prevent it from doing so thereby increasing the distance between the occlusal and gingival portions of the ligature when mounted on the bracket.
Miller further discloses with respect to claim 10, wherein the ligature is configured such that a distance between the mesial and distal portions in the pre-mounting state is substantially the same as after fitting around the orthodontic bracket. Such that depending on the shape and/or size of the bracket in relation to the ligature, the distance between the mesial and distal portions would be substantially the same in the pre-mounted and mounted state. Such that the size of the bracket is of a size that when the ligature is placed on it, would be substantially the same or smaller as the distance between the mesial and distal portions of the ligature so that the mesial and distal portions can return to their stored memory shape when fixed on the bracket.
Miller further discloses with respect to claim 11, wherein the ligature is configured such that in the pre-mounting state, a distance between the mesial and distal portion is larger than after fitting around the orthodontic bracket. Such that depending on the size and/or shape of the bracket in relation to the ligature, the ligature is configured as claimed. Such that the ligature could be stretched in the occlusal and gingival direction a large amount reducing the distance between the mesial and distal portions and the shape of the bracket is such that it would allow for distance to be reduced between the mesial and distal portions in order to allow for greater stretching in the occlusal/gingival direction.
Miller further discloses with respect to claim 12, wherein the ligature is configured such that in the pre-mounting state, a distance between the mesial and distal portions is smaller than after fitting around the orthodontic bracket. Such that the ligature is configured to function as claimed such that depending on the size and/or shape of the bracket in relation to the ligature, the ligature can be stretched when fit around the bracket so that the distance between the mesial and distal portions is increased, such that the bracket prevents the mesial and distal portions from returning to their original distance.
Miller further discloses with respect to claim 13, wherein the loop in the pre-mounting state is substantially circular in a top view (see fig. 12).
Miller further discloses with respect to claim 15, wherein the superelastic material is nitinol (see abstract, col. 3, ll. 64-65).
Miller further discloses with respect to claim 16, wherein the ligature is made from a wire that is welded at its ends to from the closed loop (see fig. 12, col. 3, ll. 62-63).
Miller further discloses with respect to claim 20, the ligature comprising marking 24 indicating an orientation for mounting around an orthodontic bracket (see fig. 12, such that the weld is a mark that indicated orientation).
Miller further discloses with respect to claim 21, an orthodontic kit comprising the ligature according to claim 1 (see detailed rejection above) and an orthodontic bracket (see fig. 11 such that the two are provided together and are a kit), the orthodontic bracket comprising an arch wire slot 8 and one or more wings 10 on a gingival side of the arch wire slot, and one or more wings 10 at an occlusal side of the arch wire slot, and wherein the wings are configured to retain the ligature (col. 3, ll. 48-61, such that hook 22 is part of the wing).
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Claim(s) 1-13, 15-16, 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanson (5,885,074).
Hanson discloses with respect to claim 1, a ligature (see fig. 3) made of superelastic material (see abstract, col. 5, ll. 43-46), and configured to be fitted around an orthodontic bracket (col. 5, ll. 17-20), wherein the ligature forms a closed loop (see fig. 3, col. 5, ll. 32-36)) configured to fit around the orthodontic bracket and be retained around the orthodontic bracket based on a superelastic effect of the material of the ligature (col. 5, ll. 13-20, abstract, such that the loop is stretched over the bracket and the superelastic properties of the material of the loop will attempt to return to its original shape once the force to stretch the loop is removed and exert a force on the bracket). With respect to all the claims, it is noted that all the limitations with respect to how the loop is retained on the bracket and how the shape/size of the ligature changes between a pre-mounted and a mounted configuration are functional. It is noted that if the structure of the prior art is capable of functioning as claimed, then the claimed limitations are met. It is noted that the orthodontic bracket is NOT being claimed, only that the loop that is capable of being retained around a bracket and configured to interact with the bracket as claimed. Therefore, the prior art only needs to teach the loop capable of functioning as claimed in order to meet the claimed limitations.
Hanson further discloses with respect to claim 2, prior to fitting around the orthodontic bracket, a curvature along an occlusal-gingival direction (see annotated figure below). It is noted that fig. 12 shows the ligature before it is placed on the bracket and moving in/along an occlusal-gingival direction the ligature has a curve.
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Hanson further discloses with respect to claim 3, comprising, prior to fitting around the orthodontic bracket, one or more wave-shaped segments (see fig. 3, col. 5, ll. 14-35)
Hanson further discloses with respect to claim 4, the ligature comprising an occlusal portion configured to be arranged at an occlusal side of the bracket, a gingival portion configured to be arranged at a gingival side of the bracket, a mesial portion configured to be arranged at a mesial side of the bracket, and a distal position configured to be arranged as a distal side of the bracket (see annotated figure above, such that the ligature is capable of being placed and arranged in the mouth so that the sides are orientated in the desired directions).
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Hanson further discloses with respect to claim 5, wherein the occlusal and/or gingival portion comprise a wave shaped segment (see annotated figure above, such that each of the portions have a wave shape segment).
Hanson further discloses with respect to claim 6, wherein the mesial and/or distal portion comprise a wave-shaped segment (see annotated figure above, such that each of the portions have a wave shape segment).
Hanson further discloses with respect to claim 7, wherein the ligature is configured such that in a pre-mounting state, a perimeter of the loop is the same as the perimeter of the loop after fitting around the orthodontic bracket, and wherein in the pre-mounting state, a distance between the occlusal portion and the gingival portion and/or a distance between the mesial portion and the distal portion is different than after fitting around the orthodontic bracket. It is noted that the limitations of claim 7 are functional such that the structure of the prior art is configured to function as claimed. It is noted that apparatus disclosed by Hanson is the same as what is claimed, such as a closed loop made out of a superelastic material. Therefore, since the loop is a closed loop, the perimeter would be the same in both positions, as it is a continuous perimeter around the ligature. Further depending on the shape and/or size of the bracket that the ligature is mounted on and further the orientation of the ligature when placed on the bracket, the ligature would have a different distance between the occlusal portion and the gingival portion and/or a distance between the mesial portion and the distal portion then when in the pre-mounted state. Such that the ligature is configured to be stretched over a bracket to be retained thereon. Depending on the size of the bracket, the ligature may be stretched and not able to return to it memorized shape due to the bracket impeding the ligature, make the distance in either or both claimed directions to be different in that it would be greater than in the pre-mounted state. It is noted that the ligature is configured to function in a variety of ways as later claimed and discussed in detail. The above explanation is just one example of how it is configured to function as claimed.
Hanson further discloses with respect to claim 8, wherein the ligature is configured such that in a pre-mounting state the mesial and distal portion have more curvature than after fitting around the orthodontic bracket. Such that the ligature disclosed by Hanson is capable of functioning as claimed. As discussed above, depending on the size and/or shape of the bracket in relation to the ligature, when the ligature is fitted on the bracket is capable of having a shape with less curvature in the mesial and distal portions then when in the pre-mounted positions. Such that when the ligature is placed on the bracket, it may be stretched in the occlusal gingival direction, resulting in elongation of the mesial and distal portions, which would reduce the curvatures of the wave portions in the mesial and distal portions. Such that the bracket would prevent the ligature to returning to its pre-mounted shape.
Hanson further discloses with respect to claim 9, wherein the ligature is configured such that a distance between the occlusal portion and the gingival portion in the pre-mounting state is smaller than after fitting around the orthodontic bracket. Such that when the ligature is placed on the bracket, depending on the size and/or shape of the bracket relative to the ligature, the distance would be as claimed. For example the distance of the bracket in the occlusal and gingival direction is greater than the distance between the occlusal and gingival portions of the ligature so that when the ligature is placed on the bracket and stretched, the ligature would not be able to fully return to its original shape, including the distance between the occlusal and gingival portions as the bracket would prevent it from doing so thereby increasing the distance between the occlusal and gingival portions of the ligature when mounted on the bracket.
Hanson further discloses with respect to claim 10, wherein the ligature is configured such that a distance between the mesial and distal portions in the pre-mounting state is substantially the same as after fitting around the orthodontic bracket. Such that depending on the shape and/or size of the bracket in relation to the ligature, the distance between the mesial and distal portions would be substantially the same in the pre-mounted and mounted state. Such that the size of the bracket is of a size that when the ligature is placed on it, would be substantially the same or smaller as the distance between the mesial and distal portions of the ligature so that the mesial and distal portions can return to their stored memory shape when fixed on the bracket.
Hanson further discloses with respect to claim 11, wherein the ligature is configured such that in the pre-mounting state, a distance between the mesial and distal portion is larger than after fitting around the orthodontic bracket. Such that depending on the size and/or shape of the bracket in relation to the ligature, the ligature is configured as claimed. Such that the ligature could be stretched in the occlusal and gingival direction a large amount reducing the distance between the mesial and distal portions and the shape of the bracket is such that it would allow for distance to be reduced between the mesial and distal portions in order to allow for greater stretching in the occlusal/gingival direction.
Hanson further discloses with respect to claim 12, wherein the ligature is configured such that in the pre-mounting state, a distance between the mesial and distal portions is smaller than after fitting around the orthodontic bracket. Such that the ligature is configured to function as claimed such that depending on the size and/or shape of the bracket in relation to the ligature, the ligature can be stretched when fit around the bracket so that the distance between the mesial and distal portions is increased, such that the bracket prevents the mesial and distal portions from returning to their original distance.
Hanson further discloses with respect to claim 13, wherein the loop in the pre-mounting state is substantially circular in a top view (see fig. 3, such that it is a loop that is substantially circular in that it has an overall circular shape with some waves in it).
Hanson further discloses with respect to claim 15, wherein the superelastic material is nitinol (see abstract, col. 5, ll. 43-47).
Hanson further discloses with respect to claim 16, wherein the ligature is made from a wire that is welded at its ends to from the closed loop, col. 4, ll. 31-39, col. 5, ll. 33-35).
Hanson further discloses with respect to claim 20, the ligature comprising marking indicating an orientation for mounting around an orthodontic bracket (see fig. 3, col. 5, ll. 33-35, such that the joint of the ends is a marking as claimed).
Hanson further discloses with respect to claim 21, an orthodontic kit comprising the ligature according to claim 1 (see detailed rejection above) and an orthodontic bracket (col. 5, ll. 14-35, such as the two are disclosed together and therefore are a kit), the orthodontic bracket comprising an arch wire slot 42 and one or more wings 40 on a gingival side of the arch wire slot, and one or more wings 38 at an occlusal side of the arch wire slot, and wherein the wings are configured to retain the ligature (see fig. 8, which it is noted that the embodiment of the spiral ligature is shown with the bracket, Hanson discloses the wave ligature with the bracket in the same manner).
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) 19 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hanson (5,885,074).
Hanson teaches that the ligature wire is made of a flat strip of metal, but is silent as to how the strip is made. The claimed phrase “is made by blanking from a flat metallic sheet” is being treated as a product by process limitation; that is, that the ligature wire is blanked/cut from a flat sheet of metal. As set forth in MPEP 2113, product by process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Hanson is silent as to the process used from the ligature wire, it appears that the product in Hanson would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of flat metallic wire (col. 5, ll. 20-33).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (5,885,074) as applied to claim 1 above, and further in view of Gladstone (2,767,469).
Hanson discloses each and every structural element of the ligature in claim 1 (see claimed detailed rejection above)
Hanson teaches that the ligature is made from a flat metal wire, but is silent as to the method of making. The claimed phrase “is made by blanking from a flat metallic sheet” means that the ligature was made by blanking/cutting a flat metal sheet, as explained in the instant application.
Gladstone teaches that blanking is a known method for forming ligatures (col. 1, ll. 24-28, such as it is stamped/blanked from a sheet of metal).
Therefore, even if “blanking from a flat metallic sheet” results in different structural characteristics of the end product than other methods, it still would have been prima facie obvious at the time the invention was made to use a “blanking” material in Hanson as claimed since Gladstone teaches that blanking/stamping is recognized as a useful technique for forming ligatures.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller (4,725,229) as applied to claim 16 above, and further in view of Hanson (5,885,074).
Miller teaches the invention as substantially claimed and discussed above, however, does not specifically teach the ligature has a diameter of 0.008-0.012 inches.
Hanson teaches a ligature made of superelastic material and configured to be fitting around an orthodontic bracket, wherein the ligature forms a closed loop configured to fit around the orthodontic bracket and be retained around the orthodontic bracket based on a superelastic effect of the material of the ligature (see abstract). Hanson further teaches the wire for the ligature has a diameter of 0.008-0.012 inches (col. 4, ll. 48-51, such that a diameter of the ligature, in cross section of the wire, is within the claimed range). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the diameter of the wire used for the ligature taught by Miller with that taught by Hanson in order to provide the desired fitting and forces on the bracket.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller (4,725,229) as applied to claim 1 above, and further in view of Siegel (WO 2012/069774).
Miller teaches the invention as substantially claimed and discussed above, however, does not specifically teach wherein the ligature is made by woven or braided wires or wire bundles.
Siegel teaches an orthodontic device made of a wire of superelastic material and the wire is braided wire or wire bundles (see par. 13, 17, 20, 22, 24). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the ligature with the single wire of superelastic material taught by Miller to includes braided wires or wire bundles taught by Siegel in order to provide a ligature with superior strength against breaking (see par. 13 of Siegel).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 2/6/2026