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 .
Claim Objections
Claims 23,28,29 are objected to because of the following informalities:
In claim 23, line 2, “the teeth” has no prior antecedent basis. It appears that –of a user—or similar should be inserted after “teeth”.
In claim 28, line 4, “of the both the” appears to include an extraneous “the”.
In claim 29, line 3, “the performance of the distalization” has no prior antecedent basis, and it appears that this claim should depend from claim 26. For purposes of this action, claim 29 will be assumed to depend from claim 26.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 8 and 17 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In claim 8, line 2, “surrounding at least one tooth” appears to encompass a human organism. It is suggested that “surrounding” be amended to read –adapted to surround—to overcome this rejection.
In claim 17, line 2, “additional thickness at the tip of a tooth” appears to encompass a human organism. It is suggested that –adapted to be—be inserted after “thickness”.
In claim 17, line 3, “in an interproximal space between two teeth” appears to encompass a human organism. It is suggested that –adapted to be—be inserted before “in”.
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.
Claims 1-7,12,14,15,16,17,18,23,24,26,27,28,31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kopelman et al 20170007360.
With regard to claim 1, Kopelman et al discloses an orthodontic aligner (see for example, fig. 12A and 12B), comprising: an inner functional layer comprised of an elastomer; and a non-elastomeric outer functional layer. This embodiment is described in paragraphs 156 and 158 where Kopelman et al discloses that the inner portion (layer) may be formed of an elastic material and the outer portion (layer) may be non-elastomeric/rigid.
With regard to claim 2, note that the outer layer may be comprised of a biocompatible rigid or semi-rigid polymer. See paragraph 83 which describes how the aligner may be formed of polymer. See paragraphs 158, 263 and 324, which discloses where portions (layers) of the aligner may be “rigid”.
With regard to claims 3 and 4, note that the inner functional layer and outer functional layer may be made of a functionally graded material, which may be a functionally graded polymer having greater elasticity at the inner functional layer and greater rigidity at the outer functional layer. See paragraph 156 which discloses how stiff or rigid material can be deposited at locations where increased stiffness is desired. This is considered to be a “functionally graded polymer”, since Kopelman et al contemplates a polymeric aligner that may be more rigid at an outer layer (see above).
With regard to claim 5, note that the aligner may comprise a plurality of inner cavities within the inner layer, each inner cavity shaped to receive therein a tooth attachment. See paragraph 84.
With regard to claim 6, note that the inner cavities are configured to receive (capable of receiving) therein lingual tooth attachments. See paragraph 121.
With regard to claim 7, note that elastomeric inner functional layer is molded to fit a tooth with sufficient tightness to function as a gasket preventing entry of food particles between the tooth and the orthodontic aligner. See paragraph 130 which describes how the inner layer may engage undercuts of the teeth. This constitutes being “molded” to fit a tooth with sufficient tightness.
With regard to claim 12, note that Kopelman et al discloses at least one region of increased thickness on an external face of the outer functional layer. See paragraph 155 which discloses that an additional material may be deposited at a located where increased stiffness is desired, and Kopelman et al already discloses that the outer layer of material may be rigid (paragraph 158). The limitation of “said region of increased thickness corresponding to a region of decreased thickness of a corresponding tooth or arch point” is considered to be functional in nature because it refers to the teeth, which are not being positively claimed, therefore the increased thickness of the aligner of Kopelman et al is considered to be capable of “corresponding to a region of decreased thickness of a corresponding tooth” when worn in the mouth.
With regard to claim 14, note that Kopelman et al discloses at least one pontic 2102 (fig. 21) wherein the pontic 2102 is comprised of a material of the outer functional layer over an entire dimension of the pontic and includes the material of the inner functional layer at a gingival margin. See paragraph 232 which discloses how the pontic can be integrally formed as a single piece with the shell. Therefore, since the pontic is integrally formed with the shell, it necessarily is comprised of a material of the outer functional layer 1202 (see fig. 12A) over the entire dimension of the pontic (see fig. 21 how the pontic occupies the entire portion of the tooth shaped outline of the shell), and it necessarily also includes the material of the inner functional layer (1204, fig. 12A) at a gingival margin.
With regard to claim 15, note that Kopelman et al discloses that the aligner may further comprise an extended portion 1902 (see fig. 19) configured to extend over a hard palate of a patient, said extended portion comprised of the material of the outer functional layer, the material of the inner functional layer, a semi-flexible acrylic, or a hard acrylic. See paragraph 229. Note that Kopelman et al discloses that the extended portion is “integrally formed” with the aligner, and thus necessarily is formed of the material of either the outer for inner functional layers.
With regard to claim 16, note that Kopelman et al discloses that the outer layer is comprised of regions having various thicknesses so as to form a veneer 2102 and thereby smooth out an appearance of adjacent teeth. See paragraph 231 which discloses how an additional material can be applied to the surface of the shell (thus the outer layer) which inherently forms regions of varying thicknesses.
With regard to claim 17, note that Kopelman et al discloses how the regions of various thicknesses include at least one of additional thickness at the tip of a tooth and additional thickness in an interproximal space between two teeth. See figure 21 which shows how the pontic/veneer 2102 is formed on the outer layer, and occupies the entire tooth area of the aligner, including the tip and interproximal areas. Since Kopelman et al discloses that the pontic/veneer may be formed by applying an additional material (paragraph 231), this results in an additional thickness at the tip and interproximal space.
With regard to claim 18, note that Kopelman et al discloses a system for orthodontic treatment, comprising: the orthodontic aligner of claim 1 (see above regarding claim 1); and one or more aligner attachments configured for attachment onto a patient's teeth. See paragraphs 120 and 159.
With regard to claim 23, Kopelman et al 20170007360 discloses a method of orthodontic treatment comprising an orthodontic aligner (see figs. 12A,12B) and affixing such to the teeth, the orthodontic aligner comprising an inner functional layer comprised of an elastomer; and a non-elastomeric outer functional layer. This embodiment is described in paragraphs 156 and 158 where Kopelman et al discloses that the inner portion (layer) may be formed of an elastic material and the outer portion (layer) may be non-elastomeric/rigid.
With regard to claim 24, note that Kopelman et al includes a plurality of inner cavities within the inner layer, each inner cavity shaped to receive therein an aligner attachment (see paragraphs 84 and 121, and the method further comprises applying aligner attachments to a plurality of teeth; and wherein the affixing step comprises overlaying the inner cavities over the aligner attachments.
With regard to claim 26, note that the aligner of Kopelman et al comprises at least one interproximal section, said interproximal section being configured to apply an interproximal force, and the method further comprises performing distalization with the at least one interproximal section. See paragraph 224.
With regard to claim 27, note that Kopelman et al discloses performing sequential molar distalization with a series of orthodontic aligners (see paragraph 86) each having different sections of increased thickness (paragraph 155 discloses adding additional thickness to selected portions of the aligner).
With regard to claim 28, note that Kopelman et al contemplates wherein the at least one interproximal section of a first aligner of the series is comprised of the elastomeric functional layer functioning as a spacer (see paragraphs 156 and 158 which discloses how the inner layer (which is located at an interproximal location, see fig. 12A/12B) being elastomeric and thus inherently functions as a spacer), and the at least one interproximal section of a subsequent aligner of the series is comprised of material of the both the elastomeric functional layer and the outer functional layer. This is also contemplated by Kopelman et al, as Kopelman et al disclose that the aligner may be provided as a series of aligners. Thus, any subsequent aligner inherently has both the elastomeric inner layer and outer functional layer located interproximally. See figure 12A.
With regard to claim 31, note that Kopelman et al discloses wherein the step of affixing the orthodontic aligner to the teeth comprises affixing the aligner to the teeth when the outer functional layer is already adhered to the inner functional layer. See figs. 12A and 12B which show the inner and outer functional layers adhered together.
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.
Claims 8-11,13 are rejected under 35 U.S.C. 103 as being unpatentable over Kopelman et al 20170007360.
With regard to claims 8-11,13, Kopelman et al does not explicitly disclose a combined thickness of the outer and inner functional layers is up to 800 µm in a region surrounding at least one tooth, nor that a thickness of the outer functional layer in said region is up to approximately 100 microns at a region corresponding to a root of a tooth, and up to approximately 500 microns at a region corresponding to a tip of the tooth, and a thickness of the inner functional layer is between approximately 300 to 400 microns at the root, and between approximately 50 to 100 microns at the tip. Kopelman et al also does not disclose wherein the aligner maintains structural integrity at temperatures of between approximately -3°C to 105 °C. Kopelman et al also does not disclose wherein the aligner maintains structural integrity at pressures of up to approximately 800 psi. Kopelman et al also does not disclose wherein the region of increased thickness has a thickness of up to approximately 8,000 µm.
However, it appears that one skilled in the art would have had a reasonable expectation of success in selecting the thicknesses recited to fall within the claimed ranges, as such only involves adjusting the recited thicknesses to provide the stated desired property of increased thickness at certain areas of the aligner. Therefore, it would have been obvious to one skilled in the art to provide the aligner of Kopelman et al to have thicknesses in the ranges recited in claims 8,9 and 13, as a matter of routine optimization, since it has been held that "[W]here 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 233, 235 (CCPA1955).
Furthermore, it also appears that one skilled in the art would have had a reasonable expectation of success in selecting the temperature range and pressures at which the aligner maintains structural integrity to be in the ranges recited in claims 10 and 11, as such only involves adjusting these parameters to achieve a desired stability of the aligner in certain atmospheric conditions. Therefore, it would have been obvious to one skilled in the art to provide the aligner of Kopelman et al to have stability with the temperature range and pressures as recited in claims 10 and 11, as a matter of routine optimization, since it has been held that "[W]here 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 233, 235 (CCPA1955).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman et al 20170007360 in view of Wen et al 20060234179.
With regard to claim 19, Kopelman et al does not disclose metal rings or snap buttons for affixation onto molars.
Wen et al disclose an aligner that includes snap buttons 930/940 (see fig. 9 and paragraph 56 which discloses that the attachments may be in the form of buttons).
It would have been obvious to one skilled in the art to include snap buttons for affixation onto molars, with the aligner of Kopelman et al, in view of the teaching of Wen et al that snap buttons may be used to connect an aligner to molar teeth.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman et al 20170007360 in view of Jensen et al 20230293266.
With regard to claim 20, Kopelman et al does not disclose a plurality of magnets, including a first set of magnets for affixation onto teeth and a second set of magnets for affixation onto the aligner.
Jensen et al discloses an orthodontic aligner which utilizes magnets. A first set of magnets is attached to the aligner, and a second set of magnets is attached to the teeth. See paragraphs 17, 25 and 26 which disclose how a set of magnets may be used on the front teeth, and a set on the rear teeth.
It would have been obvious to one skilled in the art to include first and second sets of magnets with the aligner of Kopelman et al, in view of the teaching of Jensen et al that first and second sets of magnets may be used with an aligner to assist in repositioning teeth.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman et al 20170007360 in view of Leslie-Martin 20080003541.
With regard to claim 21, Kopelman et al does not disclose a temporary grill applied over the outer functional layer.
Leslie-Martin discloses an applique/decal (which is temporary) applied over the outer functional layer of an aligner type device, and may occupy several teeth locations. See fig. 5 and paragraphs 30,37,43 and 51 which disclose that the decal/applique may comprise any desired design.
It would have been obvious to one skilled in the art to include a temporary grill over the outer functional layer of the Kopelman et al aligner, in view of the teaching of Leslie-Martin that a temporary design may be applied to the outer functional layer of a mouthpiece-type device.
Claims 22 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Kopelman et al 20170007360 in view of Kopelman et al 20140363779.
With regard to claims 22 and 29, Kopelman et al does not disclose at least one chain for raising and exposing an impacted tooth.
Kopelman et al 20140363779 discloses an aligner that may be used with a chain for raising an impacted tooth. See paragraphs 41 and 46.
It would have been obvious to one skilled in the art to include a chain with the aligner of Kopelman et al 20170007360, as taught by Kopelman et al 20140363779, if one wished to be able to raise an impacted tooth with the aligner of Kopelman et al 20170007360.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman et al 20170007360 in view of Phan et al 6309215.
With regard to claim 25, Kopelman et al does not disclose wherein the step of applying aligner attachments comprises applying the attachments to a lingual side of the teeth.
Phan et al discloses an aligner that is attached to teeth via attachments. Phan et al also discloses that attachments may be attached to a lingual side of the teeth. See figure 7.
It would have been obvious to one skilled in the art to apply the attachments disclosed in the method of Kopelman et al to the lingual side of the teeth, in view of the teaching of Phan et al that an aligner may be attached to the teeth via attachments secured to the lingual side of the teeth.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman et al 20170007360 in view of Wu et al 20170007364.
Kopelman et al does not explicitly disclose wherein the step of affixing the orthodontic aligner to the teeth comprises first affixing the inner functional layer and subsequently overlaying the outer functional layer onto the inner functional layer.
Wu et al discloses a dual layer aligner in which an inner functional layer 610 is affixed to the teeth, and then an outer functional layer 620 is overlaid on the inner functional layer. See fig. 6 which shows how inner layer 610 is installed first. See also paragraph 122.
It would have been obvious to one skilled in the art to include the step of first affixing the inner functional layer, followed by the outer functional layer, in the method of orthodontic treatment of Kopelman et al, in view of the teaching of Wu et al that a dual layer aligner can be affixed to teeth layer by layer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS D LUCCHESI whose telephone number is (571)272-4977. The examiner can normally be reached M-F 800-430.
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/NICHOLAS D LUCCHESI/Primary Examiner, Art Unit 3772