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 .
Response to Amendment
This action is in response to Applicant’s amendment filed 4/22/26.
The amendments to the abstract filed 4/22/26 have been entered.
Response to Arguments
Applicant's arguments filed 4/22/26 have been fully considered but they are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments.
Briefly, regarding the remaining rejections under 35 USC 112, B, Applicant traverses the rejections by pointing to [0029]-[0072] of the instant disclosure. The Examiner has reviewed the citations, however the citations do not clarify the issues (as recited and detailed below). Accordingly, Applicant’s arguments have been fully considered but are not persuasive.
Specification
The amendment filed 8/13/24 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “The entire disclosure of which is herein incorporated by reference”. The Examiner notes that incorporation by reference after the filing date of the application amounts to inclusion of new matter into the specification. The incorporation by reference must be removed.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 1, 3-8 and 11 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.
Regarding claims 1 and 11, the term “measuring functional, orthopedic and orthodontic diagnostic factors” is indefinite, as it is generally unclear how the listed factors are measured (see below). Additionally, it is unclear how said measurements of the diagnostic factors are factored in the computer implemented method to determine the set of corrective parameters. While the instant disclosure broadly describes “an algorithm” to allow the computer to determine the corrective parameters from the diagnostic factors, no details, steps, values, equations, etc. of such algorithms are provided (see [0035]). Accordingly, since the instant method is a computer implemented method and recites measurement of the factors, the disclosure must provide guidance as to how said quantitative values of said factors are considered, weighted, and/or otherwise used by the algorithm to determine the corrective parameters. As stated above, the disclosure provides no such guidance. Additionally, the Examiner refers to the specific deficiency of specific measurements of specific diagnostic factors below.
Regarding the term “lingual posture” it is unclear how the factor is measured and/or quantified. The original disclosure merely states that a lingual posture may be determined, however it is unclear how it is measured (e.g. assigned a quantitative value) and implemented by an algorithm to determine a corrective parameter.
Regarding the term “nasal breathing”, the original disclosure merely states that the computer may detect the presence of a deviated nasal septum, and as such it is unclear specifically how “nasal breathing” is measured and how a measured value of “nasal breathing” is implemented into the specific algorithm to determine corrective parameters.
Regarding the term “mastication” the original disclosure states that a user can chew different textures and consistencies. Alternatively the disclosure states that an EMG device can be used to obtain signals reflecting mastication disorders, however, while a disorder can be identified, it is unclear how “mastication” is specifically measured, and implemented into an algorithm to determine corrective parameters.
Regarding the term “swallowing”, the original disclosure states that a user can drink or swallow different quantities of water or food. Alternatively, the disclosure states than an EMG device can be used to obtain signals reflecting swallowing disorders, however, while a disorder can be identified, it is unclear how “swallowing” is specifically measured, and implemented into an algorithm to determine corrective parameters.
Regarding the term “speech and salivation”, no specific examples of how “speech” is measured or quantified are listed in the original disclosure; only that electronic equipment using unspecified “algorithms” can be used to “estimate” problems in speech and salivation [0035]. Alternatively, the disclosure states that an EMG device can be used to obtain signal reflecting speech or salivation disorders. Accordingly, it is unclear how speech and salivation are quantitatively measured and how such measurements are implemented into an algorithm to determine the corrective parameters. The disclosure provides no guidance of how such factors are measured.
Regarding the term “orofacial muscle tone”, the original disclosure provides no guidance as to how muscle tone is measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters.
Regarding the term “labial competence”, the original disclosure provides no guidance as to how labial competence is measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters. Further it is unclear how the measurement of “labial postures” is distinct from the measure of “labial competence”; e.g. it is unclear what one factor measures vs the other.
Regarding the term “coordination of tongue movements”, the original disclosure provides no guidance as to how coordination of tongue movement is measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters.
Regarding the term “labial postures”, the original disclosure provides no guidance as to how labial postures are measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters. Further it is unclear how the measurement of “labial postures” is distinct from the measure of “labial competence”; e.g. it is unclear what one factor measures vs the other.
Regarding the term “joint and/or muscle pain”, although the original disclosure states that the presence of joint and/or muscle pain may be considered, the original disclosure provides no guidance as to how joint and/or muscle pain are measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters.
Regarding the term “tissue and musculoskeletal malformations”, although the original disclosure states that the presence of tissue and musculoskeletal malformations may be considered, the original disclosure provides no guidance as to how tissue and musculoskeletal malformations are measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters.
Regarding the term “geometric and structural relationships between the upper and lower dental arches”, although the original disclosure states that the presence of geometric and structural relationships between the arches may be considered, the original disclosure provides no guidance as to how the relationships are measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters. Further it is unclear how the measurement of “geometric and structural relationships between the upper and lower dental arches” is distinct from the measure of “coordination of jaw movements”, “resting position of the mandible”, “skeletal imbalances”, “occlusal balance”; e.g. it is unclear what one factor measures vs the other.
Regarding the term “coordination of jaw movements”, although the original disclosure states that the coordination of jaw movements may be considered, the original disclosure provides no guidance as to how the movements are measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters. Further it is unclear how the measurement of “coordination of jaw movements” is distinct from the measure of “geometric and structural relationships between the upper and lower dental arches”, “resting position of the mandible”, “skeletal imbalances”, “occlusal balance”; e.g. it is unclear what one factor measures vs the other.
Regarding the term “a resting position of the mandible”, although the original disclosure states that the resting position of the mandible may be considered, the original disclosure provides no guidance as to how the resting position is measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters. Further it is unclear how the measurement of “resting position of the mandible” is distinct from the measure of “geometric and structural relationships between the upper and lower dental arches”, “coordination of jaw movements”, “skeletal imbalances”, “occlusal balance”; e.g. it is unclear what one factor measures vs the other.
Regarding the term “skeletal imbalances”, although the original disclosure states that skeletal imbalances may be considered, the original disclosure provides no guidance as to how the imbalances are measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters. Further it is unclear how the measurement of “skeletal imbalances” is distinct from the measure of “geometric and structural relationships between the upper and lower dental arches”, “coordination of jaw movements”, “resting position of the mandible”, “occlusal balance”; e.g. it is unclear what one factor measures vs the other.
Regarding the term “occlusal balance”, although the original disclosure states that occlusal balance may be considered, the original disclosure provides no guidance as to how the balance is measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters. Further it is unclear how the measurement of “occlusal balance” is distinct from the measure of “geometric and structural relationships between the upper and lower dental arches”, “coordination of jaw movements”, “resting position of the mandible”, “skeletal imbalances”; e.g. it is unclear what one factor measures vs the other.
Regarding the term “tooth location and alignment”, although the disclosure states that tooth location and alignment are measured, it is unclear what the alignment and location measured are compared to. For example, a tooth location or alignment must be measured in reference to either another tooth, a desired position, an ideal position, etc. The specification provides no detail as how alignment and location are measured. Additionally, it is unclear how said measurement is incorporated into an algorithm to generate the corrective parameters. Further, it is unclear how the measurement of “tooth location and alignment” is distinct from “tooth inclination and rotation”, “crowding or overlapping teeth”, and “missing teeth”; as best understood, consideration of location and alignment corresponds to considering inclination, rotation, and crowding or overlapping teeth.
Regarding the term “interdental space size”, although the disclosure states that interdental spaces can be measured, it is unclear how said measurement is incorporated into an algorithm to generate the corrective parameters.
Regarding the term “crowding or overlapping teeth”, although the original disclosure states that tooth crowding/overlap may be considered, the original disclosure provides no guidance as to how it is measured or quantified and otherwise how such data would be incorporated into an algorithm to generate the corrective parameters. Further, it is unclear how the measurement of “crowing or overlapping teeth” is distinct from “tooth inclination and rotation”, “tooth location and alignment”, and “missing teeth”; as best understood, consideration of location and alignment corresponds to considering inclination, rotation, and crowding or overlapping teeth.
Regarding the term “dental arch contractions…or expansions”, although the disclosure states that arch expansions and contractions are measured, it is unclear what the contraction or expansions measured are compared to. For example, an arch contraction or expansion must be measured in reference to a desired arch, average arch, etc. The specification provides no detail as how contractions or expansions are measured. Additionally, it is unclear how said measurement is incorporated into an algorithm to generate the corrective parameters.
Regarding the term “missing teeth”, although the disclosure states that missing teeth can be measured, it is unclear what said measurement is (e.g. size of gap, tooth number that is missing, etc.), and how said measurement is incorporated into an algorithm to generate the corrective parameters.
Regarding the term “abnormalities in tooth shape and size”, although the disclosure states that tooth shape and size can be measured, it is unclear what said measurement is (e.g. size of tooth, percentage of size compared to normal, etc), and how said measurement is incorporated into an algorithm to generate the corrective parameters.
Regarding the term “measuring” the diagnostic factors, the Examiner notes that it is unclear if several of said factors are actually measured (see above) or if they are merely estimated as disclosed in the original disclosure (see [0029], [0030] and [0035]).
Finally, the term “said diagnostic factors” in steps c and d are indefinite as it is unclear what diagnostic factors (e.g. functional, orthodontic or orthopedic” the term refers too.
All other claims not specifically addressed above are rejected based on their dependency and/or incorporation of claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see attached PTO892 form.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD MORAN whose telephone number is (571)270-5349. The examiner can normally be reached Monday-Friday 7 AM-4 PM EST.
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/EDWARD MORAN/Primary Examiner, Art Unit 3772
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