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 .
Priority
Acknowledgment is made of applicant’s claim for domestic priority under 35 U.S.C. 119 (e)). Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119 (e) as follows:
Claim 5: The specification does not disclose the radius values of claim 5 (1mm-2mm).
Claims 6, 7, 9: The specification discloses a lower buccal extension (25) in Paragraph [0027], but there is no mention of an upper buccal extension.
For the purpose of examination, the priority date for claims 1-4 is 06/09/2023. The priority date for claims 5-7, and 11-16 is 02/09/2024.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the upper and lower spacers of claims 2, 7, and 10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Fig. 1, 12A, 12B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 14A, 14B. 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. 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:
Missing space between "12" and "are", page 10, line 10
Missing space between "25" and "as", page 11, line 12
Spacer , spacers and ridge, are all used to describe "22"; for consistency, Examiner recommends using one term (page 11, lines 6, 9, 17).
Appropriate correction is required.
Claim Objections
Claims 1, 2 and 8 objected to because of the following informalities:
Claim 1, line 6, “providing” should be changed to “provides”.
Claim 2, line 3 is missing "to" between "relative" and "said".
Claim 8, line 3 should be amended to add “configured to” after “a unitary construction”.
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, 6 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waterman et al. (US 20210330488 A1).
Regarding claim 1, Waterman et al. discloses an oral appliance (302) for promoting nasal breathing and for suppressing oral breathing of a wearer (refer to Paragraph [0001]), the oral appliance (302) comprising:
an upper flange (306) providing a plurality of upper teeth impressions dimensioned and shaped to snugly receive the upper teeth of the wearer (refer to Paragraph [0061]; the upper region (306) is configured to fit the upper dental arch (438));
a lower flange (304) unitary with the upper flange (refer to Paragraph [0061]; the appliance (302) is one piece), wherein the lower flange (304) providing a plurality of lower teeth impressions dimensioned and shaped to snugly receive the lower teeth of the wearer with their lower jaw in a retruded position (refer to Paragraph [0061], [0117]; the lower region (304) fits the lower dental arch (440); the one piece appliance (302) is configured to fit the lower jaw (412) of the user (410) in a natural position; in light of the specification, Examiner understands a retruded position of the lower jaw as the relaxed or “natural” position of the jaw (refer to page 6, line 23)); and
a closed wall (refer to annotated Fig. 3 below) extending between said flanges (304, 306) so that the closed wall prevents passage of an airflow between said flanges (refer to Paragraph [0062]; the one-piece appliance (302) prevents air from exiting the mouth region (434) by providing a physical barrier).
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Regarding claim 6, Waterman et al. discloses the oral appliance of claim 1, further comprising an upper buccal vestibule barrier (refer to annotated Fig. 2 below) extending superiorly from the upper flange (306); and
a lower buccal vestibule barrier (refer to annotated Fig. 1 below) extending inferiorly from the lower flange (304), wherein each buccal vestibule barrier is configured to occupy a buccal vestibule adjacent thereto so as to prevent passage of the airflow through the respective buccal vestibule (refer to Paragraph [0067], annotated Figs. 1, 2 below; a third and fourth seal is formed along the upper jaw (418) and lower jaw (412) by covering the upper and lower gumlines to thereby prevent air from escaping through the mouth).
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Regarding claim 8, Waterman et al. discloses an oral appliance (302) for promoting nasal breathing and for suppressing oral breathing of a wearer (refer to Paragraph [0001]), the oral appliance (302) comprising:
a unitary construction that occupies the oral cavity to prevent passage of an airflow from an external environment to the pharyngeal passageway of the wearer by way of the mouth of the wearer when the mandible is in a retruded position (refer to Paragraphs [0061], [0062], [0117]; the one-piece appliance (302) prevents air from entering or exiting the mouth region (434) by providing a physical barrier; the one piece appliance (302) is configured to fit the lower jaw (412) of the user (410) in a natural position; in light of the specification, Examiner understands a retruded position of the lower jaw as the relaxed or “natural” position of the jaw (refer to page 6, line 23).
Regarding claim 9, Waterman et al. discloses the oral appliance of claim 8, further comprising:
a plurality of impressions within the oral appliance for receiving upper and lower teeth of the wearer (refer to Paragraphs [0066], [0141], annotated Fig. 2 below; the one-piece appliance (302) can also be constructed to the upper dental arch (438) and the lower dental arch (440) based on molding to a dental impression); and
upper (refer to annotated Fig. 2 below) and lower barriers (refer to annotated Fig. 1 below) that occupy the superior and inferior buccal vestibules, respectively, of the wearer (refer to Paragraph [0067], annotated Figs. 1, 2 below; a third and fourth seal is formed along the upper jaw (418) and lower jaw (412) by covering the upper and lower gumlines).
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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) 2-5, 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waterman et al. (US 20210330488 A1) in view of Laich (EP 2742920 A1); refer to the provided translation for Laich.
Regarding claim 2, Waterman et al. discloses the oral appliance of claim 1, but is silent to an upper or lower spacer.
Laich discloses a mouth insert (16) in the analogous art of mouthguards (refer to Paragraph [0001]), wherein the mouth insert (16) comprises an upper flange (upper portion of 17), lower flange (lower portion of 17), further comprising an upper spacer (6) and a lower spacer (7), each spacer unitary with each upper flange (upper portion of 17) and the lower flange (lower portion of 17), respectively (refer to Paragraph [0033]; the protective elements (17) are form on the upper (6) and lower (7) connecting tubes), wherein each spacer (6, 7) anteriorly protrudes relative said flanges (refer to annotated Fig. 2 below). The spacers (6, 7) form a holding structure in such a way that a secure hold of the mouth insert (16) in the mouth is ensured (refer to Paragraph [0009]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the oral appliance (302) of Waterman et al. with the spacers (6, 7) as taught by Laich in order to provide a holding structure to retain the orthodontic appliance (16) in the mouth (refer to Paragraph [0009]).
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Regarding claim 3, the combination of Waterman et al. and Laich discloses the oral appliance of claim 2, with Waterman et al. disclosing wherein the closed wall (refer to annotated Fig. 3 of Waterman above) is posteriorly recessed relative to the upper (306) and lower flanges (304). Waterman et al. is silent to the spacers.
Laich further discloses wherein the upper and lower flanges (17) are posteriorly recessed relative to the spacers (6, 7) (refer to annotated Fig. 2 of Laich above; the spacers (6,7) are shown protruding from the upper and lower flanges (17)).
In the combined invention, the spacers (6,7) would therefore also protrude from the portion of the closed wall as disclosed by Waterman, which is shown as being recessed from the upper (306) and lower flanges (304).
Regarding claim 4, the combination of Waterman et al. and Laich discloses the oral appliance of claim 3; however, Waterman et al. is silent to lateral spacer portions.
Laich further discloses lateral spacer portions (lateral portions of 6, 7) that interconnect the upper (6) and lower spacers (7) so as to define a closed loop (refer to annotated Fig. 2 below). The lateral spacer portions also form the holding structure, which secures the mouth insert (16) in the mouth (refer to Paragraph [0009]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the oral appliance (302) od Waterman et al. with lateral spacer portions as taught by Laich in order to form the holding structure for securing the appliance (16) in the mouth (refer to Paragraph [0009]).
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Regarding claim 5, the combination of Waterman et al. and Laich discloses the oral appliance of claim 4, Waterman et al. does not disclose dimensions of the spacers or lateral spacer portions.
Laich discloses wherein the spacers (6, 7) and lateral spacer portions (lateral portions of 6, 7) are semicircular (refer to annotated Fig. 2 below; based on Applicant’s disclosure, Examiner understands the semicircular portion of the spacers (22) as the anteriorly protruding “semi-circle” projection shown in Fig. 5 (refer to page 11, lines 8-15), which is the same shape of the semi-circular protruding portion of the spacers (6, 7) shown in annotated Fig. 2 of Laich), having a radius of between one and two millimeters (refer to Paragraph [0019]; the wall thickness of the connecting tubes (6, 7) is 15-25% of the outer diameter of the tubes (6, 7), where this thickness ranges from 0.5mm-1.0mm; this means the diameter of the tubes (6, 7) is between 2 mm - 6.66 mm (25% of 2 mm is 0.5 mm, and 15% of 1 mm is 6.67 mm), meaning the radius of the semi-circular portion is in the range of 1 mm- 3.33 mm). Laich discloses that the spacers (6, 7) are designed to not impede with the wearers ability to close their lips, only abutting against the inner surface of the wearer’s lips (refer to Paragraph [0028]; the holding structure is disposed in the non-visible section of the mouth to not impair the lower lip band (11) or upper lip band (10)), which is the same purpose of the radius of the spacer ridges (22) of Applicant’s device (refer to page 11, lines 11-12).
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Further, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the oral appliance (302) of Waterman et al. with dimensioned spacers of 1 mm-2 mm in radius as taught by Laich in order to not impede with the wearers ability to close their lips (refer to Paragraph [0028]).
Regarding claim 7, Waterman et al. discloses the oral appliance of claim 1, further comprising:
an upper buccal vestibule barrier (refer to annotated Fig. 2 below) extending posteriorly from the upper flange (306); and
a lower buccal vestibule barrier (refer to annotated Fig. 1 below) extending inferiorly from the lower flange (304), wherein each buccal vestibule barrier is configured to occupy a buccal vestibule adjacent thereto so as to prevent passage of the airflow through the respective buccal vestibule (refer to Paragraph [0067], annotated Figs. 1, 2 below; a third and fourth seals are formed along the upper jaw (418) and lower jaw (412) by covering the upper and lower gumlines to thereby prevent air from escaping through the mouth).
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Waterman et al. is silent to an upper spacer, lower spacer, or lateral spacer portions.
Laich discloses a mouth insert (16) in the analogous art of mouthguards (refer to Paragraph [0001]), wherein the mouth insert (16) comprises an upper flange (upper portion of 17), lower flange (lower portion of 17), further comprising an upper spacer (6) and a lower spacer (7), each spacer unitary with each upper flange (upper portion of 17) and the lower flange (lower portion of 17), respectively (refer to Paragraph [0033]; the protective elements (17) are form on the upper (6) and lower (7) connecting tubes), wherein each spacer (6, 7) anteriorly protrudes relative said flanges (refer to annotated Fig. 2 below). Laich further discloses lateral spacer portions (lateral portions of 6, 7) that interconnect the upper (6) and lower spacers (7) so as to define a closed loop (refer to annotated Fig. 2 below). The spacers (6, 7) form a holding structure in such a way that a secure hold of the mouth insert (16) in the mouth is ensured (refer to Paragraph [0009]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the oral appliance (302) of Waterman et al. with the spacers (6, 7) as taught by Laich in order to provide a holding structure to retain the orthodontic appliance (16) in the mouth (refer to Paragraph [0009]).
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Waterman et al. discloses wherein the closed wall (refer to annotated Fig. 3 of Waterman above) is posteriorly recessed relative to the upper (306) and lower flanges (304). Waterman et al. is silent to the spacers.
Laich further discloses wherein the upper and lower flanges (17) are posteriorly recessed relative to the spacers (6, 7) (refer to annotated Fig. 2 of Laich above; the spacers (6,7) are shown protruding from the upper and lower flanges (17)).
In the combined invention, the spacers (6,7) would therefore also protrude from the portion of the closed wall as disclosed by Waterman, which is shown as being recessed from the upper (306) and lower flanges (304).
Waterman et al. does not disclose dimensions of the spacers or lateral spacer portions.
Laich discloses wherein the spacers (6, 7) and lateral spacer portions (lateral portions of 6, 7) are semicircular (refer to annotated Fig. 2 below; based on Applicant’s disclosure, Examiner understands the semicircular portion of the spacers (22) as the anteriorly protruding “semi-circle” projection shown in Fig. 5 (refer to page 11, lines 8-15), which is the same shape of the semi-circular protruding portion of the spacers (6, 7) shown in annotated Fig. 2 of Laich), having a radius of between one and two millimeters (refer to Paragraph [0019]; the wall thickness of the connecting tubes (6, 7) is 15-25% of the outer diameter of the tubes (6, 7), where this thickness ranges from 0.5mm-1.0mm; this means the diameter of the tubes (6, 7) is between 2 mm - 6.66 mm (25% of 2 mm is 0.5 mm, and 15% of 1 mm is 6.67 mm), meaning the radius of the semi-circular portion is in the range of 1 mm- 3.33 mm). Laich discloses that the spacers (6, 7) are designed to not impede with the wearers ability to close their lips, only abutting against the inner surface of the wearer’s lips (refer to Paragraph [0028]; the holding structure is disposed in the non-visible section of the mouth to not impair the lower lip band (11) or upper lip band (10)), which is the same purpose of the radius of the spacer ridges (22) of Applicant’s device (refer to page 11, lines 11-12).
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Further, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the oral appliance (302) of Waterman et al. with dimensioned spacers of 1 mm-2 mm in radius as taught by Laich in order to not impede with the wearers ability to close their lips (refer to Paragraph [0028]).
Regarding claim 10, Waterman et al. discloses the oral appliance of claim 9, wherein the oral appliance (302) is configured to receive the lower teeth of the wearer with their lower jaw in a retruded position, such that a distal edge of the lips sealably contact when the mandible is in the retruded position (refer to Paragraph [0061], [0087], [0117]; the lower region (304) fits the lower dental arch (440); the one piece appliance (302) is configured to fit the lower jaw (412) of the user (410) in a natural position whether the mouth (434) is open or closed; in light of the specification, Examiner understands a retruded position of the lower jaw as the relaxed or “natural” position of the jaw (refer to page 6, line 23)); however, Waterman et al. is silent to an upper or lower spacer.
Laich discloses a mouth insert (16) in the analogous art of mouthguards (refer to Paragraph [0001]), wherein the mouth insert (16) comprises an upper flange (upper portion of 17), lower flange (lower portion of 17), further comprising anteriorly protruding upper (6) and lower (7) spacers (refer to Paragraph [0033], annotated Fig. 2; below the protective elements (17) are form on the upper (6) and lower (7) connecting tubes), for abutting an inner surface of the upper and lower lips of the wearer so that a distal edge of said lips sealably contact (refer to Paragraphs [0006], [0028]; the holding structure is disposed in the non-visible section of the mouth to not impair the lower lip band (11) or upper lip band (10)). The spacers (6, 7) form a holding structure in such a way that a secure hold of the mouth insert (16) in the mouth is ensured, without impeding the function of the lips closing (refer to Paragraphs [0009], [0028]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the oral appliance (302) of Waterman et al. with the spacers (6, 7) as taught by Laich in order to provide a holding structure to retain the orthodontic appliance (16) in the mouth without impeding the function of the lips closing (refer to Paragraphs [0009], [0028]).
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Claim(s) 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waterman et al. (US 20210330488 A1) in view of Laich (EP 2742920 A1) as applied to claim 7 above, and further in view of Carlson et al. (US 20180147039 A1); refer to the provided translation for Laich.
Regarding claim 11, Waterman discloses a method (Fig. 12) of making a unitary oral appliance (302) of claim 7, the method comprising:
using an impression material configured to capture a size, a shape, and a position of each tooth in the lower and upper jaws of the wearer (refer to Paragraphs [0136], [0140]; an upper and lower form are obtained from a soft material); and
fabricating the unitary oral appliance (302) having extensions into the buccal vestibules of the wearer to restrict oral air exchange when breathing orally (refer to Paragraphs [0067], [0141]; a forming machine can be used to vacuum form a thermoplastic to the dental impressions, where the third and fourth seals are formed along the upper jaw (418) and lower jaw (412) by covering the upper and lower gumlines to thereby prevent air from escaping through the mouth).
Neither Waterman et al. or Laich disclose using a bite registration material to determine a separation value or placing a model of the teeth of the wearer on a dental articulator.
Carlson et al. discloses a method of collecting bite information in the analogous art of dentistry (refer to Paragraph [0006]). The method comprises the steps of:
using a bite registration material configured for determining a separation value between a lower jaw and an upper jaw of the wearer (refer to Paragraphs [0132], [0133], [0135]; wax is used to capture the position of the patient’s mandible 1½-2 mm from contacting the maxillary teeth), wherein the separation value is determined when the lower jaw and the upper jaw are in a relaxed position relative to each other (refer to Paragraphs [0138], [0139]; Examiner understands the relaxed or “natural” position of the jaw as a retruded position of the lower jaw as (refer to page 6, line 23); the anterior and posterior bite registration pieces represent the centric relation, which is equivalent to a retruded position of the lower jaw); and
placing a model of the teeth of the wearer on a dental articulator (100) adapted and configured to account for the separation value (refer to Paragraphs [0138], [0140]; the models are mounted on the articulator (100) in centric relation).
This method is desirable for linking the model to the mechanics of the patient’s bite (refer to Paragraph [0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of making a unitary oral appliance (302) as taught by Waterman et al. and Laich with the method of using bite registration material and a dental articulator (100) as taught by Carlson et al. in order to link the model to the mechanics of the patient’s bite (refer to Paragraph [0054]).
Regarding claim 12, the combination of Waterman et al., Laich and Carlson et al. discloses the method of claim 11. Waterman et al. and Laich do not disclose the model being stone.
Carlson et al. further discloses wherein the model is a stone model (refer to Paragraph [0158], Fig. 1A; upper and lower stone casts are mounted to the mounting jig (100)).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of making a unitary oral appliance (302) as taught by Waterman et al. and Laich with stone models as taught by Carlson et al. in order to link the model to the mechanics of the patient’s bite (refer to Paragraph [0054]).
Regarding claim 13, the combination of Waterman et al., Laich and Carlson et al. discloses the method of claim 12. Waterman et al. and Laich do not the fabricating step occurring in a dental lab.
Carlson et al. further discloses wherein the fabricating step occurs in a dental lab (refer to Paragraph [0053]; the devices made as a result of the physical cast are made in the lab using the model as a guide) for quickly interacting with the model to produce the oral devices (refer to Paragraph [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of making a unitary oral appliance (302) as taught by Waterman et al. and Laich with in lab fabrication as taught by Carlson et al. for quickly interacting with the model to produce the oral devices (refer to Paragraph [0053]).
Regarding claim 14, Waterman discloses a method (Fig. 13) of making a unitary oral appliance (302) of claim 7, the method comprising:
using an oral scanning device configured to capture a size, a shape, and a position of each tooth in the lower and upper jaws of the wearer (refer to Paragraph [0145]; a digital image of the person’s mouth (434) is created); and
fabricating the unitary oral appliance (302) having extensions into the buccal vestibules of the wearer to restrict oral air exchange when breathing orally (refer to Paragraphs [0067], [0147]; additive manufacturing can be used to form the one-piece appliance (302), where the third and fourth seals are formed along the upper jaw (418) and lower jaw (412) by covering the upper and lower gumlines to thereby prevent air from escaping through the mouth).
Neither Waterman et al. or Laich disclose using a bite registration material to determine a separation value or placing a model of the teeth of the wearer on a dental articulator.
Carlson et al. discloses a method of collecting bite information in the analogous art of dentistry (refer to Paragraph [0006]). The method comprises the steps of:
using a bite registration material configured for determining a separation value between a lower jaw and an upper jaw of the wearer (refer to Paragraphs [0132], [0133], [0135]; wax is used to capture the position of the patient’s mandible 1½-2 mm from contacting the maxillary teeth), wherein the separation value is determined when the lower jaw and the upper jaw are in a relaxed position relative to each other (refer to Paragraphs [0138], [0139]; Examiner understands the relaxed or “natural” position of the jaw as a retruded position of the lower jaw as (refer to page 6, line 23); the anterior and posterior bite registration pieces represent the centric relation, which is equivalent to a retruded position of the lower jaw); and
placing a model of the teeth of the wearer on a dental articulator (100) adapted and configured to account for the separation value (refer to Paragraphs [0057], [0112]; in light of Applicant’s specification, Examiner understands placing a virtual model on a dental articulator as equivalent to virtually modeling the patient’s bite for replication on the physical dental articulator; the patient’s bite is simulated digitally using the modeled bite model and CBCT data to then model the same positioning on the dental articulator).
This method is desirable for simulating motion using digital data (refer to Paragraph [0057]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of making a unitary oral appliance (302) as taught by Waterman et al. and Laich with the method of using bite registration material and a dental articulator (100) as taught by Carlson et al. in order to simulate motion using digital data (refer to Paragraph [0057])
Regarding claim 15, the combination of Waterman et al., Laich and Carlson et al. discloses the method of claim 14, with Waterman et al. disclosing wherein the model is a virtual model (refer to Paragraph [0146]; the digital image can be converted into a CAD file).
Regarding claim 16, the combination of Waterman et al., Laich and Carlson et al. discloses the method of claim 15, Waterman et al. and Laich do not the fabricating step occurring in a dental lab.
Carlson et al. further discloses wherein the fabricating step occurs in a dental lab (refer to Paragraph [0053]; the devices made as a result of the physical cast are made in the lab using the model as a guide) for quickly interacting with the model to produce the oral devices (refer to Paragraph [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of making a unitary oral appliance (302) as taught by Waterman et al. and Laich with in lab fabrication as taught by Carlson et al. for quickly interacting with the model to produce the oral devices (refer to Paragraph [0053])
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adriena J Webb Lyttle whose telephone number is (571)270-7639. The examiner can normally be reached Mon - Fri 8:00-5:00 EST.
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/ADRIENA J WEBB LYTTLE/Examiner, Art Unit 3772
/THOMAS C BARRETT/SPE, Art Unit 3799