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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 1/5/26 is acknowledged. The traversal is on the ground(s) that the non-elected invention requires all the particulars of the elected invention. This is not found persuasive because non-elected claim 9 is directed to a device formed by the method of elected claim 1. Specifically, claim 9 is a product by process claim and is not limited by the particular steps of the process, only by the structure imparted thereon. Accordingly claim 9 is significantly broader and can be formed by numerous other methods of forming and still result in the same customized device.
The requirement is still deemed proper and is therefore made FINAL.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/5/26.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
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 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “computing unit” in claim 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
However, the term “computing unit” is unclear and is not described in the specification and the corresponding structure is not defined (see below).
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 1-8 and 10-12 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 claim 1, the claim is indefinite for multiple reasons. First, the term “oral system” is indefinite as it is unclear what would or would not specifically be considered as part of the “oral system”; e.g. it is unclear what the term encompasses. Second, the terms “functional, orthopedic and orthodontic diagnostic factors” is indefinite as it is unclear what specifically said “diagnostic factors” actually comprise, how they are evaluated or measured, and how they are determined to be in need of correction. The “factors” appear to be based solely on the discretion of the user and as such are entirely subjective. Still further, it is unclear what the difference is between “functional” and “orthopedic” diagnostic factors, as several conditions which Applicant uses to describe the factors in the disclosure, overlap significantly with each other (for example, ventilation, mastication, swallowing, etc. are tied to the relationship of the upper and lower jaws). Third, the step of “determining a set of corrective parameters” is indefinite as it depends on the determined parameters, and like above it is unclear how said parameters are measured or determined; like above the corrective parameters appear to be entirely subjective. Correction is required.
Regarding claim 2, the step of “determining” the functional, orthopedic and orthodontic diagnostic factors are indefinite for the reasons as explained above. Further, the use of the term “relating to” and listing several conditions which can be evaluated, renders the limitations indefinite as it is unclear whether or not the specific listed conditions are evaluated, whether or not all or some are evaluated, or whether an evaluated condition merely has to be related to one or more of the listed conditions. In other words it is unclear what specific conditions must be evaluated by the claim. As best understood by the Examiner, so long as one or more conditions, or conditions related thereto, are evaluated, such an evaluation would read on the “determining” “factors relating to” such conditions. Further, it is unclear how such conditions are specifically being evaluated, and the evaluation itself is indefinite as no numerical valuation, measure or metric of said factors is recited, instead being entirely subjective. Regarding the factors themselves, the terms “ventilation”, “orofacial muscle tone”, “labial competence”, “coordination of tongue movements”, and “presence of labiolingual malpositions” are themselves indefinite as it is unclear what specifically said factors comprise and how they are determined to be compliant or not. Still further, as explained above, there is significant overlaps in the factors listed in steps a-c, and it is unclear how they can all be independently assed. Correction is required.
Regarding claim 3, the term “generating a 3D model of the patient’s oral system” is indefinite as it is unclear how this 3D model is different from the “initial model” of claim 1. As best understood by the Examiner, they appear to be directed to the same model and will be interpreted as such. Clarification is required.
Regarding claim 10, the term “computing unit” is indefinite as it is unclear what specifically the term refers to. The specification does not clarify the issue. As best understood by the Examiner the “computing unit” refers to a processor and will be interpreted as such. Further, the claim is directed to a “computer system” for manufacturing an aligner. However, the claim only recites the computing unit, and does not recite the system for manufacturing. It is unclear how the system can manufacture the aligner without the system for manufacturing (system for manufacturing should be claimed). Clarification is required.
Regarding claims 11-12, the terms are indefinite as it is unclear what specifically the claims correspond to. As noted below, the claims can read on a signal per se, however it is unclear whether or not Applicant intends to claim the signal, or if they claims should be directed to non-transitory computer readable medium. Clarification is required.
All other claims not specifically addressed above are rejected based on their dependency on a previously rejected claim.
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.
Claims 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims encompass a signal per se, which does not fall within one of the four statutory categories. Applicant should amend the claim to recite a non-transitory computer readable medium, or the like (see MPEP 2106303(II); In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007)). 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) 1-8 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falkel (US 11364098 B2), as evidenced by Wen (US 2017/0100214 A1, incorporated therein by reference), as best understood by the Examiner.
Regarding claim 1, as best understood by the Examiner, Falkel discloses a method for manufacturing a personalized corrective dental aligner for correcting a patient's oral system, the method being implemented by a computer system (see abstract; col 2, line 29-48; col 3, lines 5-10; col 4, lines 15-60; col 5, lines 1-3, 41-45, 61-65 (incorporating Wen), col 11, lines 48-58; col 14, lines 63-67; col 15, lines 1-18, 64-67; col 16, lines 1-3, 32-33; col 17, lines 45-65; col 18, lines 36-45; col 19, line 58-col col 20, line 65; col 21, lines 5-10; col 23, lines 20-26; col 24, lines 12-16; col 25, lines 22-26; col 26, lines 8-23; col 28, line 62 through col 30, line 26; and Wen, Figs. 1a-3a), characterized in that it comprises the following steps: a. a step wherein the computer system receives at least one 3D model, known as the initial model, of the patient's oral system (e.g. loaded model, see col 29, lines 1-3) b. a step for determining functional, orthopedic and orthodontic diagnostic factors of the patient's oral system (see diagnostic factors determined/considered for treatment, col 2, lines 29-49; col 4, lines 15-60); c. a step of determining a set of corrective parameters of the patient's oral system from said diagnostic factors (e.g. simulation and design of corrective geometry and components, see col 29, lines 3-30; 35-41 and citations above); d. a step of generating a 3D model, known as a corrective model, from the initial model, said corrective parameters and said diagnostic factors (e.g. completed/final model prior to forming, after simulation; see col 29, lines 1-67); e. a step of generating at least one 3D model of a customized corrective aligner, enabling the initial model to be transformed into the corrective model (e.g. final appliance model prior to direct fabrication thereof; see col 29, lines 1-65); f. a step of manufacturing a corrective aligner from said 3D model of a customized dental aligner (see col 29, lines 31-33 and lines 60-67). See also Wen, Figs. 1-3a and associated sections thereof describing the specific computer implemented planning steps of 3D digital modeling and treatment planning for orthodontic devices, incorporated into Falkel for such purpose. The Examiner notes that forming a 3D physical device or 3D physical model for vacuum forming a device thereover requires the use of 3D data or digital models in order to provide the required data.
Regarding claim 2, Falkel discloses the method according to claim 1, characterized in that said step for determining functional, orthopedic and orthodontic diagnostic factors of the patient's oral system comprises: a. determining functional diagnostic factors (see functional diagnostic factors listed at col 2, lines 29-48 and col 4, lines 14-60) relating to the patient's lingual postures, ventilation, mastication, swallowing, speech and salivation, orofacial muscle tone, labial competence, coordination of tongue movements, presence of labiolingual malpositions, presence of joint and/or muscle pain, and presence of tissue and musculoskeletal malformations (as best understood by the Examiner, the functional diagnostic factors listed in the citations above are at least related to and/or encompass the above parameters, at least to some degree); b. determining orthopedic diagnostic factors (see orthopedic diagnostic factors listed at col 2, lines 29-48 and col 4, lines 14-60) relative to the geometric and structural relationships between the upper and lower dental arches, the coordination of jaw movements, the resting position of the mandible and the presence of skeletal imbalances (as best understood by the Examiner, the orthopedic diagnostic factors listed in the citations above are at least related to and/or encompass the above parameters, at least to some degree); c. determining orthodontic diagnostic factors (see orthodontic diagnostic factors listed at col 2, lines 29-48 and col 4, lines 14-60; e.g. alignment of the teeth, see also col 15, line 60 through col 16, line 35, also incorporating and encompassing Wen’s orthodontic tooth modeling steps, see above) relative to tooth location and alignment, tooth inclination and rotation, interdental space size, the presence of crowding or overlapping teeth, the presence of dental arch contractions or dental arch expansions, missing teeth, occlusal balance and the presence of anomalies in tooth shape and size (as best understood by the Examiner, the orthodontic diagnostic factors listed in the citations above are at least related to and/or encompass the above parameters, at least to some degree).
Regarding claim 3, Falkel discloses the method according to claim 1 characterized in that the step of receiving a 3D model of the patient's oral system is preceded by a step of providing at least one dentofacial image of the patient (see col 28, lines 63-67 and col 29, lines 29-32, 38-50) and a step of generating a 3D model of the patient's oral system from said dentofacial image (e.g. initial model, as best understood by the Examiner, see col 29, lines 1-3).
Regarding claim 4, Falkel discloses at least one dentofacial image is obtained from dental impressions or three-dimensional images of the patient's oral system (e.g. scans and/or cameras, see Falkel and Wen citations above).
Regarding claim 5, Falkel discloses that the step of generating at least one 3D model of a customized corrective aligner comprises generating a sequence of 3D models enabling the initial model to be progressively transformed into the corrective model; and in that it comprises a sequence of steps for manufacturing a corrective aligner from each of the 3D models of said sequence of 3D models (e.g. series of steps and corresponding appliances, see citations above).
Regarding claim 6, Falkel discloses that step of manufacturing the corrective dental aligner is implemented by an aligner additive manufacturing method from the 3D model of the customized corrective aligner (e.g. 3D printing, see col 29, line 66-67).
Regarding claim 7, Falkel discloses that step of manufacturing the aligner is implemented by a method for resin and/or silicone molding of the aligner from the 3D model of the customized corrective dental aligner (e.g. vacuum forming, see col 29, lines 32-33 and 63).
Regarding claim 8, Falkel discloses that the step of generating at least one 3D model of a customized corrective aligner involves adding elements designed to correct dental and/or bone malpositions to the 3D model (see col 29, lines 15-24, col 21, lines 5-10 and citations above).
Regarding claim 10, Falkel discloses a computer system for manufacturing a customized corrective dental aligner, comprising a computing unit (e.g. processor of computer) arranged to implement the method according to claim 1 (see citations above; computer system described in col 29 to perform said method).
Regarding claim 11, Falkel discloses a computer program product, recorded on a data carrier, and comprising program code which is adapted, when executed by a computer, to implement the method of claim 1 (e.g. programming on computer to perform said method as described in col 29).
Regarding claim 12, Falkel discloses a data carrier whereupon the computer program according to claim 11 is recorded (e.g. memory, drive or signal of said computer described in col 29, which stores said programming).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see attached PTO892 form.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at 571-270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDWARD MORAN/Primary Examiner, Art Unit 3772