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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Specifically, in claim 2, line 5, “dental adhesion means” is being interpreted under 35 U.S.C. 112(f), sixth paragraph.
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 14 and 20 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.
In claim 14, lines 1 and 2, “is of a color of the dentition of the patient” is indefinite. This limitation relies on a relationship with teeth of a patient, and since teeth vary in color from patient to patient, there is no way to determine the metes and bounds of this claim.
In claim 20, lines 2-3, “preferably” and “more preferably” render the claim indefinite, as the metes and bounds of the claim cannot be determined. For purposes of this action, this claim will be interpreted as “…wherein the material comprises filler materials.”
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 1-4,8,9,10,12,13,15,16,17,19,20 are rejected under 35 U.S.C. 103 as being unpatentable over Barth 20180304541 in view of Hung 20180303582.
With regard to claim 1, Barth discloses a dental aligner (fig. 1) comprising means for applying a displacement force, identical or different, on each tooth of the dentition of a patient, wherein said means comprising at least one active portion on the aligner (the aligner applies a force), and wherein said dental aligner is made using a material comprising a photoinitiator and/or a thermoinitiator. See paragraphs 29 (which discloses photoinitiators) and 46 (which discloses thermoinitiators). It is noted that the recitation in line 6 “by directly 3D printing” is considered to be a product by process limitation which does not carry structural weight in an apparatus claim. Since the final product required by claim 1 only requires a material having either a photoinitator or a thermoinitiator, Barth is considered to meet this limitation.
Barth does not disclose a thickness ranging from 0.3 mm to 6 mm.
Hung discloses a dental aligner which may have a thickness between 0.5 – 1.5mm. See paragraph 31.
It would have been obvious to one skilled in the art to provide the aligner of Barth with a thickness 0.5 to 1.5mm, which includes values that fall within applicant’s claimed range, in view of the teaching of Hung that such values are appropriate for the thickness of a dental aligner.
With regard to claim 2, note that Barth discloses a surface condition selected from smooth surface, rough surface, and surface comprising dental adhesion means. Specifically, Barth discloses a “smooth” surface. See surface 12 in figure 1, for example.
With regard to claims 3 and 8, note that Barth discloses that the material may comprise a photoinitiator, which may be benzophenone. See paragraph 59.
With regard to claim 4, note that Barth discloses that the material may comprise a thermoinitiator, which may be a peroxide. See paragraph 46.
With regard to claim 9, note that Barth/Hung discloses a range of 0.5 to 1.5mm for the thickness (paragraph 31 of Hung) which includes values recited in this claim.
With regard to claim 10, note that Barth/Hung discloses a range of 0.5 to 1.5mm for the thickness (paragraph 31 of Hung) which includes values recited in this claim.
With regard to claim 12, note that dental aligner of Barth/Hung is made of a biocompatible matter (the aligner is worn in the mouth, therefore is made of biocompatible matter).
With regard to claim 13, note that the dental aligner of Barth/Hung is configured to reconstruct a shape of a tooth or teeth. This occurs when the aligner is worn in the mouth and moves the teeth in the mouth, thus reconstructing the shape of the teeth as a set.
With regard to claim 15, note that the aligner of Barth/Hung comprises at least at least two different materials. See paragraph 83 of Barth.
With regard to claim 16, note that Barth discloses that the dental aligner may be colored. See paragraph 53 of Barth which discloses that a pigment may be included.
With regard to paragraph 17, note that the dental aligner of Barth/Hung is transparent. See paragraph 83 of Barth.
With regard to claim 19, note that Barth discloses that the material may comprise a polymer such as polyurethane. See paragraph 63.
With regard to claim 20, note that Barth discloses that the material of the aligner may comprise a filler, such as a pigment. See paragraph 53.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Barth 20180304541 in view of Hung 20180303582 and further in view of Mizuguchi et al 4140664.
With regard to claim 5, Barth/Hung does not disclose the thermoinitiator to be an azoic such as 4,4'-azobis(4-cyanovaleric) acid, nor a peroxide such as benzoyl peroxide.
Mizuguchi et al discloses a thermosetting resin which may include 4,4'-azobis(4-cyanovaleric) acid, or benzoyl peroxide as a thermoinitiator. See col. 5, lines 60-63.
It would have been obvious to one skilled in the art to use 4,4'-azobis(4-cyanovaleric) acid as a thermoinitiator in the material used to form the aligner of Barth/Hung, in view of the teaching of Mizuguchi et al that 4,4'-azobis(4-cyanovaleric) acid or benzoyl peroxide may be used as a thermoinitator in a thermosetting resin.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Barth 20180304541 in view of Hung 20180303582 and further in view of Shiobara et al 5340851.
With regard to claim 7, Barth/Hung do not disclose that the thermoinitiator is a tert-butyl peracetate.
Shiobara et al discloses a thermosetting resin that may include tert-butyl peracetate as a thermoinitiator. See col. 14, line 16.
It would have been obvious to one skilled in the art to utilize tert-butyl peracetate as a thermoinitiator in the material used to form the aligner of Barth/Hung, in view of the teaching of Shiobara et al that tert-butyl peracetate is suitable for use as a thermoinitator in a thermosetting resin.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Barth 20180304541 in view of Hung 20180303582 and Boronkay 20160199157.
With regard to claim 18, Barth/Hung do not disclose that the applied displacement force ranges from 0.0098 N.mm to 8 N.mm.
Boronkay discloses a dental positioning system in which an applied force (rotational moment) may be 5 N.mm (see paragraph 72), which falls within applicant’s claimed range.
It would have been obvious to one skilled in the art to form the aligner of Barth/Hung to be capable of applying a displacement force of between 0.0098 to 8 N.mm, in view of the teaching of Boronkay that a force of 5 N.mm is suitable for a corrective force within the oral cavity. One skilled in the art would recognize that applying forces within this claimed range would be obvious as a matter of routine optimization.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Barth 20180304541 in view of Hung 20180303582 and Kuo et al 20080138767.
With regard to claim 14, Barth/Hung do not disclose the aligner to be a color of the dentition of the patient.
Kuo et al disclose a dental aligner (see fig. 4) which may be a color of the dentition of a patient. See paragraphs 55 and 56.
It would have been obvious to one skilled in the art to form the aligner of Barth/Hung with a color of the dentition of a patient, as taught by Kuo et al, if one wished to give portions of the aligner the appearance of natural teeth of the patient.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Barth 20180304541 in view of Hung 20180303582 and Andreiko et al 20130095446.
With regard to claim 11, Barth/Hung do not disclose the parameters recited in this claim. It is noted that the claim only requires any (1) of the recited parameters.
Andreiko et al discloses a dental aligner which may have a tensile strength of 58-68 MPa, which falls within applicant’s claimed range. See paragraph 88.
It would have been obvious to one skilled in the art to form the aligner of Barth/Hung out of a material having a tensile strength of 58-68 MPa, in view of the teaching of Andreiko et al that a material with a tensile strength in this range is suitable for a dental aligner.
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
