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 .
Allowable Subject Matter
Claims 2, 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 recites: “The additively manufactured customized orthodontic tube of claim 18,” Applicant is advised to change this to: “The additively manufactured customized orthodontic tube of claim 19[[18]],”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 7 – 9 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Gualano US 2018/0360564 (hereinafter Gualano).
Regarding claim 1, Gualano teaches: an additively manufactured orthodontic tube produced by an additive manufacturing device (Fig. 9 shows an orthodontic tube; [0183] - - manufacture using a laser sintering technique), the additively manufactured orthodontic tube comprising:
a pad for bonding the customized orthodontic tube to a tooth (Fig. 10a, [0197] - - base 224 is a pad);
a gingival surface at least partially orthogonal to the pad surface (Fig. 10a, [0197] - - sidewalls 227 is gingival surface); and
a ridge gingivally protruding from the gingival surface, wherein the ridge extends along a mesial-distal direction and is sloped in a facial direction (Fig. 10a, [0197], [0192] - - retaining ridge is a ridge; “The thickened portion gradually thins in the mesial-distal direction of the bracket” this means the ridge extends along a mesial-distal direction and is sloped in a facial direction).
Regarding claim 3, Gualano teaches all the limitations of the base claims as outlined above.
Gualano further teaches: the ridge has a maximum height of at least 0.3 mm measured from a base of the ridge (Fig. 9, Fig. 10a, [0110] - - “a housing has a rectangular cross section substantially, by way of higher value, measuring 0.46.times.0.64 mm or 0.56.times.0.71 mm”; based on this dimension of the housing and Fig. 9, Fig 10a, it shows the height of the ridge is in the same scale of the housing and smaller; it is a design choice to determine the exact height).
Regarding claim 7, Gualano teaches all the limitations of the base claims as outlined above.
Gualano further teaches: the additively manufactured orthodontic tube has a volume of at least 46 mm3 (Claim 19 - - “the CCAA is less than 3.00 mm thick from the nearest tooth bonding surface to its outer edges”. Fig. 9 shows the length and width of the tube are a little greater than the depth, here it is assumed to be 4mm. Thus the total volume of the tube may be 3*4*4=48 mm3 It is a design choice to design the volume to be greater than 46 mm3).
Regarding claim 8, Gualano teaches all the limitations of the base claims as outlined above.
Gualano further teaches: the additively manufactured orthodontic tube has a volume of at least 39 mm3 (Claim 19 - - “the CCAA is less than 3.00 mm thick from the nearest tooth bonding surface to its outer edges”. Fig. 9 shows the length and width of the tube are a little greater than the depth, here it is assumed to be 4mm. Thus the total volume of the tube may be 3*4*4=48 mm3 It is a design choice to design the volume to be greater than 39 mm3).
Regarding claim 9, Gualano teaches all the limitations of the base claims as outlined above.
Gualano further teaches: the additively manufactured orthodontic tube has a volume of at least 31.77 mm3 (Claim 19 - - “the CCAA is less than 3.00 mm thick from the nearest tooth bonding surface to its outer edges”. Fig. 9 shows the length and width of the tube are a little greater than the depth, here it is assumed to be 4mm. Thus the total volume of the tube may be 3*4*4=48 mm3 It is a design choice to design the volume to be greater than 31.77 mm3).
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.
Claims 4 – 6, 10, 12 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gualano US 2018/0360564 (hereinafter Gualano) in view of Griffin et al. US 2019/0377327 (hereinafter Griffin).
Regarding claim 4, Gualano teaches all the limitations of the base claims as outlined above.
But Gualano does not explicitly teach:
a fracture groove in a portion of the additively manufactured orthodontic tube that is bounded in part by the pad and the gingival surface, the fracture groove comprising a bottom
surface and two side surfaces adjacent to the bottom surface, wherein the bottom surface is flat.
However, Griffin teaches:
a fracture groove in a portion of the additively manufactured orthodontic tube that is bounded in part by the pad and the gingival surface, the fracture groove comprising a bottom surface and two side surfaces adjacent to the bottom surface, wherein the bottom surface is flat (Fig. 6a-6c, 7a,7b, [0050]-[0052] - - the auxiliary fracture groove is a fracture groove, Fig. 6a shows a flat bottom surface of the auxiliary fracture groove).
Gualano and Griffin are analogous art because they are from the same field of endeavor. They all relate to orthodontic bracket system.
Therefore before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Gualano, and incorporating a fracture, as taught by Griffin.
One of ordinary skill in the art would have been motivated to do this modification in order to improve techniques for creating custom CCAAs, as suggested by Griffin ([0029]).
Regarding claim 5, the combination of Gualano and Griffin teaches all the limitations of the base claims as outlined above.
Griffin further teaches:
a length of the bottom surface along the mesial-distal direction is approximately 0.15mm ([0053] - - “the groove depth may be in a range of 0.10 mm to 1.0 mm”, Fig. 6c shows the fracture length is in similar dimension as the depth, thus the length of the bottom surface along the mesial-distal direction is in a range of 0.10 mm to 1.0 mm).
Gualano and Griffin are combinable for the same rationale as set forth.
Regarding claim 6, the combination of Gualano and Griffin teaches all the limitations of the base claims as outlined above.
Griffin further teaches:
material between a base of the pad and the bottom surface, wherein the material is between 0.25 mm and 0.35 mm thick. ([0053] - - “the groove depth may be in a range of 0.10 mm to 1.0 mm”, Fig. 9b shows material between a base of the pad and the bottom surface of the auxiliary groove is in this range, it is a design choice to determine the 0.25mm-0.35mm thick).
Gualano and Griffin are combinable for the same rationale as set forth.
Regarding claim 10, Gualano teaches: a method for additively manufacturing an orthodontic tube using an additive manufacturing device ([0183] - - manufacture using a laser sintering technique), the method comprising:
obtaining a three-dimensional (3D) model of one or more teeth of a patient ([0130] - - take an impression of the patient’s dentition and produce a model);
a 3D model of the orthodontic tube comprising:
a pad for bonding the customized orthodontic tube to a tooth (Fig. 10a, [0197] - - base 224 is a pad);
a gingival surface at least partially orthogonal to the pad surface (Fig. 10a, [0197] - - sidewalls 227 is gingival surface); and
a ridge gingivally protruding from the gingival surface, wherein the ridge extends along a mesial-distal direction and is sloped in a facial direction (Fig. 10a, [0197], [0192] - - retaining ridge is a ridge; “The thickened portion gradually thins in the mesial-distal direction of the bracket” this means the ridge extends along a mesial-distal direction and is sloped in a facial direction); and
using an additive manufacturing device to produce the orthodontic tube using the 3D model of the orthodontic tube ([0183] - - manufacture using a laser sintering technique).
But Gualano does not explicitly teach:
generating a 3D model of the orthodontic tube using the 3D model of the one or more teeth of the patient,
However, Griffin teaches:
generating a 3D model of the orthodontic tube using the 3D model of the one or more teeth of the patient (Fig. 1, #108, [0033] - - generate 3D CAD model of CCAA; CCAA is an orthodontic tube structure),
Gualano and Griffin are analogous art because they are from the same field of endeavor. They all relate to orthodontic bracket system.
Therefore before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Gualano, and incorporating generating a 3D model of an orthodontic tube, as taught by Griffin.
One of ordinary skill in the art would have been motivated to do this modification in order to improve techniques for creating custom CCAAs, as suggested by Griffin ([0029]).
Regarding claim 12, the combination of Gualano and Griffin teaches all the limitations of the base claims as outlined above.
Gualano further teaches: the ridge has a maximum height of at least 0.3 mm measured from a base of the ridge (Fig. 9, Fig. 10a, [0110] - - “a housing has a rectangular cross section substantially, by way of higher value, measuring 0.46.times.0.64 mm or 0.56.times.0.71 mm”; based on this dimension of the housing and Fig. 9, Fig 10a, it shows the height of the ridge is in the same scale of the housing and smaller; it is a design choice to determine the exact height).
Regarding claim 13, the combination of Gualano and Griffin teaches all the limitations of the base claims as outlined above.
However, Griffin teaches:
a fracture groove in a portion of the additively manufactured orthodontic tube that is bounded in part by the pad and the gingival surface, the fracture groove comprising a bottom surface and two side surfaces adjacent to the bottom surface, wherein the bottom surface is flat (Fig. 6a-6c, 7a,7b, [0050]-[0052] - - the auxiliary fracture groove is a fracture groove, Fig. 6a shows a flat bottom surface of the auxiliary fracture groove).
Gualano and Griffin are combinable for the same rationale as set forth.
Regarding claim 14, the combination of Gualano and Griffin teaches all the limitations of the base claims as outlined above.
Griffin further teaches:
a length of the bottom surface along the mesial-distal direction is approximately 0.15mm ([0053] - - “the groove depth may be in a range of 0.10 mm to 1.0 mm”, Fig. 6c shows the fracture length is in similar dimension as the depth, thus the length of the bottom surface along the mesial-distal direction is in a range of 0.10 mm to 1.0 mm).
Gualano and Griffin are combinable for the same rationale as set forth.
Regarding claim 15, the combination of Gualano and Griffin teaches all the limitations of the base claims as outlined above.
Griffin further teaches:
material between a base of the pad and the bottom surface, wherein the material is between 0.25 mm and 0.35 mm thick. ([0053] - - “the groove depth may be in a range of 0.10 mm to 1.0 mm”, Fig. 9b shows material between a base of the pad and the bottom surface of the auxiliary groove is in this range, it is a design choice to determine the 0.25mm-0.35mm thick).
Gualano and Griffin are combinable for the same rationale as set forth.
Regarding claim 16, the combination of Gualano and Griffin teaches all the limitations of the base claims as outlined above.
Gualano further teaches: the additively manufactured orthodontic tube has a volume of at least 46 mm3 (Claim 19 - - “the CCAA is less than 3.00 mm thick from the nearest tooth bonding surface to its outer edges”. Fig. 9 shows the length and width of the tube are a little greater than the depth, here it is assumed to be 4mm. Thus the total volume of the tube may be 3*4*4=48 mm3 It is a design choice to design the volume to be greater than 46 mm3).
Regarding claim 17, the combination of Gualano and Griffin teaches all the limitations of the base claims as outlined above.
Gualano further teaches: the additively manufactured orthodontic tube has a volume of at least 39 mm3 (Claim 19 - - “the CCAA is less than 3.00 mm thick from the nearest tooth bonding surface to its outer edges”. Fig. 9 shows the length and width of the tube are a little greater than the depth, here it is assumed to be 4mm. Thus the total volume of the tube may be 3*4*4=48 mm3 It is a design choice to design the volume to be greater than 39 mm3).
Regarding claim 18, the combination of Gualano and Griffin teaches all the limitations of the base claims as outlined above.
Gualano further teaches: the additively manufactured orthodontic tube has a volume of at least 31.77 mm3 (Claim 19 - - “the CCAA is less than 3.00 mm thick from the nearest tooth bonding surface to its outer edges”. Fig. 9 shows the length and width of the tube are a little greater than the depth, here it is assumed to be 4mm. Thus the total volume of the tube may be 3*4*4=48 mm3 It is a design choice to design the volume to be greater than 31.77 mm3).
Claims 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin et al. US 2019/0377327 (hereinafter Griffin) in view of Wallshein US 4,086,702 (hereinafter Wallshein).
Regarding claim 19, Griffin teaches: an additively manufactured orthodontic tube produced by an additive manufacturing device (Fig. 1, #108, [0035] - - using AM equipment produce CCAA based on 3D CAD CCAA model), the additively manufactured customized orthodontic tube comprising:
a pad for bonding the additively manufactured orthodontic tube to a tooth (Fig.2, [0043] - - pad);
a face extending along a buccal-lingual direction, the face comprising a rectangular slot opening for receiving a wire (Fig. 12b, [0056] - - the channel 1212 is a rectangular slot),
But Griffin does not explicitly teach:
the rectangular slot opening has a depth of at least 0.030 inches.
However, Wallshein teaches:
the rectangular slot opening has a depth of at least 0.030 inches (C7, L32-35 - - “Begg-type brackets whose wire receiving channels may be as large as 0.022 inch by 0.040 inch” 0.040 inches is at least 0.030 inches).
Griffin and Wallshein are analogous art because they are from the same field of endeavor. They all relate to orthodontic bracket system.
Therefore before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the above method, as taught by Griffin, and incorporating a slot opening has a depth of at least 0.030 inches, as taught by Wallshein.
One of ordinary skill in the art would have been motivated to do this modification in order to fit wires in the channel, as suggested by Wallshein (C7, L22-35).
Regarding claim 20, the combination of Griffin and Wallshein teaches all the limitations of the base claims as outlined above.
Wallshein further teaches: the depth of the rectangular slot opening is approximately 0.032 inches (C7, L32-35 - - “Begg-type brackets whose wire receiving channels may be as large as 0.022 inch by 0.040 inch” 0.040 inches is approximately 0.032 inches; C7, L28-31 - - “It is anticipated that rectangular arch wires having common outer dimensions no greater than approximately 0.025 inch by 0.032 inch”. The channel is for receiving arch wires, the wire is 0.032inch, thus the channel is approximately 0.032 inches).
Conclusion
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/YUHUI R PAN/Primary Examiner, Art Unit 2116