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 .
Drawings
The drawings are objected to under 37 CFR 1.84(h)(5) because Figures 2-8 show(s) modified forms of construction in the same view.
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 disclosure is objected to because of the following informalities:
Page 5, line 20 change “Primery” to “Primary”.
Appropriate correction is required.
Claim Objections
The claims are objected to because they include reference characters which are not enclosed within parentheses. For example, in claim 1 the references “upper 2 and lower 3 grooves” and “appliance for synchronization 1” and in claim 3 “synchronization is used /1/”.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Claim Objections
Claims 1-2, 4 objected to because of the following informalities:
Claim 1, line 4 change “the appliance for synchronization” to “the appliance for acceleration and synchronization”.
Claim 2, line 1 change “acceleration appliance” to “acceleration and synchronization appliance”.
Claim 4, line 4 “the walls of the acceleration” to “the walls of the acceleration and synchronization appliance”.
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.
Claim 1-3, 5 and 8-9 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 a “method for accelerating and synchronizing orthodontic treatment with dental aligners with the following characteristics the dental aligners are used together and simultaneously with an acceleration and synchronization appliance, in which the dental aligners are placed in the upper and lower grooves, and thus the appliance for synchronization is used together with the dental aligners for at least 60 minutes a day”, but fails to positively recite any steps to achieve the claimed method. As such, it is unclear what steps are needed to perform the treatment. For the purpose of examination, the claim is interpreted as placing the dental aligner together and simultaneously with an acceleration and synchronization appliance on the teeth of a patient, in which the dental aligners are placed in the upper and lower grooves of the appliance and operating the appliance and the dental aligner together for at least 60 minutes a day.
Claim 1 recites “the upper 2 and lower 3 grooves”, there is insufficient antecedent bases for this limitation in the claims. For the purpose of examination, the limitation is interpreted as the upper and lower grooves of the acceleration and synchronization appliance.
Claims 2-3 are rejected based on claim dependency on claim 1.
Claim 2 recites “the arranged orthodontic setup”, however it is unclear what is included in the determination of the arranged orthodontic setup, and if the limitation is obtained by additional steps or is a design constraints that results in a difference in the characterization of the acceleration appliance. For the purpose of examination, the limitation is interpreted as being specific to the patient or custom and the arranged orthodontic setup is the correction to a desired specific oral condition.
Claim 3 recites the limitation "the treatment plan of the patient". There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites “the type and characteristics of the orthodontic malocclusion”, the claim fails to disclose what specific type and characteristics are associated with the orthodontic malocclusion and as such it is unclear how the treatment plan takes this into consideration. For the purpose of examination, the limitation is interpreted as the one or more appliances are designed to treat the specific type of orthodontic malocclusions of the patient.
Claim 5 recites “made of ethylene vinyl acetate or a material with similar characteristics”, there is no definition or standard for a material with “similar characteristics” of ethylene vinyl acetate and therefore the claim is indefinite. Claims 8 and 9 are rejected based on claim dependency on claim 5.
Claim 8 recites “the entire length of the arc”, it is unclear if the arc is referencing the upper or lower jaw arc or the body of the appliance includes an arc shape, which has not been previously stated. For the purpose of examination, the examiner is interpreting the limitation as the body of the appliance is shaped as an arc, and that the holes are formed in body along the entire length of the arc.
Claim 9 recites “a two-component material”, it is unclear if this is in addition to the material disclosed in claim 5 or an additional two-part material. For the purpose of examination, the examiner is interpreting this limitation as two material components, so two different materials.
Claim 9 recites “the front (central part) of the arc” and “the peripheral segments of the arc”, it is unclear what arc is being referenced, if the arc is a part of the body of the appliance or the arc of the upper and lower jaw. For the purpose of examination, the limitation is interpreted as the body of the appliance is shaped as an arc so the front part of the arc of the appliance and peripheral segments of the arc of the appliance.
Claim 9 recites “the front (central) part of the arc being made of a material”, it is unclear if the central which is placed in parathesis is made of the same material as the front part of the arc, since the parenthesis make it unclear is central is a part of the claim. For the purpose of examination, the limitation is interpreted as the front part which is in a central area of the arc of the appliance is made of a material.
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.
(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 4 and 6-7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farrell (US 2007/0254256).
Regarding claim 4, Farrell discloses orthodontic appliance for acceleration and synchronization (orthodontic trainer 1), consisting of a double splint (see figures 1-7) with grooves for the upper and lower jaw (upper and lower channels 46 and 47, see par 132), characterized in that the groove for the upper jaw (46) and for the lower jaw (47) are U-shaped (see figure 4), as the minimum depth of the grooves is 4 mm (the central front region of the outer flange extending upward about 6 mm from the transverse frame member upper surface, par 43) , providing full coverage of the dental crowns and gingiva (par 61 discloses the trainer coming in contact with the teeth and gums), and the thickness T of the walls of the acceleration is at least 0.1 - 0.35 mm (par 117 discloses the transverse frame member having a width of about 2 mm) and is determined according to the individual characteristics of the patient (par 5 discloses the appliance is specifically dimensioned and configured to suit that patient’s mouth).
Regarding claim 6, applicant is advised that statement “characterized in that it is made by thermos-forming technology” is considered a product by process claim and reminded that product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP 2113. In the instant case, the prior art Farrell discloses the resulting structure and therefore is determined to anticipate the claim.
Regarding claim 7, applicant is advised that statement “is made by digitized construction” is considered a product by process claim and reminded that product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP 2113.
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.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 2022/0000656) in view of Farrell (US 2007/0254256).
Regarding claim 1, Huang discloses a method for accelerating and synchronizing orthodontic treatment with dental aligners (par 10-12 discloses the treatment of malalignment or malocclusion using a hard mandibular retainer, hard maxillary retainer and a soft retainer) with the following characteristics:
the dental aligners (hard mandibular and maxillary retainers 17 and 18) are used together and simultaneously with an acceleration and synchronization appliance (soft retainer 15), in which the dental aligners (17/18) are placed in the upper 2 and lower 3 grooves (first part 151 and second part 152).
Huang discloses the use of the appliance for synchronization (15) together with the dental aligners (17/18), but fails to disclose any usage time, specifically being used for at least 60 minutes a day.
However, Farrell discloses an oral appliance that assist in the correction of misalignment of teeth by applying a correcting force (par 2) that teaches the use of the appliance for a few hours a day (par 91) for the purpose of applying force towards the teeth towards a desired position gradually and over time (par 156).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Huang to wear the appliance of synchronization and dental aligner for a couple hours a day as taught by Farrell for the purpose of gradually moving the teeth in the desired position gradually and over time.
Regarding claim 2, Huang discloses that the acceleration appliance (15) is individual and is made in accordance with the arranged orthodontic setup and the motivational models of the patient (par 46 discloses the manufacturing of the orthodontic appliance is based on upper and lower jaw cast 51/52 to correct, reshape teeth or malocclusions).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Farrell as applied to claim 1 above, and further in view of Bergersen (US 2003/0224312).
Huang discloses a treatment plan of the patient during the orthodontic treatment with dental aligners and one appliance for acceleration according to the type and characteristics of the orthodontic malocclusion (par 10-12). Huang/Farrell fail to disclose the use of more than one appliance for acceleration and synchronization during treatment.
However, Bergersen disclosure of an orthodontic appliance for treatment of malocclusion (abstract) teaches the use of more than one appliance during the treatment (par 63).
Therefore, it would be obvious to one of ordinary skill in the art, at the time of applicant’s filing to modify Huang/Farrell to incorporate the use of more than one appliance for acceleration and synchronization during treatment as taught by Bergersen for the purpose of imparting gradual changes in teeth displacement that take into consideration changes in anatomy or dentition.
Claims 5 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Farrell as applied to claim 4 above, and further in view of Alvarez et al (US 2021/0015657).
Regarding claim 5, Farrell fails to disclose the orthodontic appliance is made of ethylene vinyl acetate.
However, Alvarez teaches an orthodontic appliance (single arch dental deice) made of ethylene vinyl acetate (par 21) for the purpose of providing flexibility to withstand trauma associated with bruxism (par 21).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Farrell to have the orthodontic appliance be made of ethylene vinyl acetate as taught by Alverez for the purpose of providing flexibility to withstand trauma.
Regarding claim 8, Farrell further discloses that holes (teeth positioning formations 50) are formed in the body of the appliance located along the entire length of the arc (see figures 5 and 6).
Regarding claim 9, Farrell further discloses the appliance (1) is made of a two- component material (the rigid underlying base member material and the encasing teeth engaging member, see par 34) , the front (central) part of the arc being made of a material with a higher stiffness than the material with which the peripheral segments of the arc are made (the central front part of the appliance arc including the more rigid base member and therefore has a higher stiffness than the peripheral segments of the appliance arch which do not have the rigid base member, see par 32-34).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached references cited.
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/S.N.B./Examiner, Art Unit 3772 /EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772