DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Responsive to the communication dated 04/23/2026
Claims 1, 6-12, and 14-18 are presented for examination
Information Disclosure Statement
The IDS dated 04/23/2026 has been reviewed. See attached.
Finality
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 extension fee 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.
Response to Arguments- 35 USC § 101
Applicant's arguments filed 04/23/2026 have been fully considered but they are not persuasive.
Applicant argues that the claimed invention is an improvement to the field of manufacturing dental restorations because it “removes the subjective step of determining whether a material and a shade or color are similar to the existing teeth in a patient's oral cavity.”
Examiner responds by explaining that this alleged improvement is facilitated entirely by the judicial exception itself, i.e. the determination of a deviation between the target and actual data sets. As such, the use of this determination, whether it be a mental comparison or a mathematic calculation of numeric differences, cannot integrate the claim into a practical applicant nor provide significantly more. (MPEP 2106.05(a)(I): An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016))
Applicant argues that the newly amended limitation of producing the dental restoration (207) by a multi-material 3D printing device or a milling device wherein a limited range of materials is used and is sufficient to produce the dental restoration. integrates the claims into a practical application/ provides significantly more.
Examiner responds by explaining that specifying that a “a limited range of materials is used and is sufficient to produce the dental restoration” is not sufficient to integrate the claims into a practical application nor provide significantly more. While this kind of amendment, i.e. the specification of certain materials to be used in production could potentially integrate the claims into a practical application if the selection of such materials were a part of the main process, that is not the case in the present claims, with no other discussion of materials being present in the independent claims. Further, that the multi-material 3D printing device or milling device uses “a limited range of materials” that is “sufficient to produce the dental restoration.” does very little to change the interpretation of the production limitation; under broadest reasonable interpretation “producing the dental restoration (207) by a multi-material 3D printing device or a milling device” on its own is understood to be done using a non-infinite amount of materials that are capable of producing the designed device.
A strong way to potentially overcome this and integrate the claims into a practical application would be to further integrate the selection of this limited range of materials into the independent claims. For example, claim 10 recites that the alteration that happens in the main iteration loop is “changing a material assignment to a sub-volume.” If this were to be moved into the independent claims and this sub-volume material assignment was directly connected to the limited range of materials used by the production device, this would likely move the claims in a significant direction towards overcoming this rejection. It is important to note, however, that the present version of the claims does not make an explicit connection between the sub-volume materials assigned in claim 10 and the limited range of materials used in the independent claims.
Further, please note that claim 16 has unaddressed issues as being directed to software per se, which is outside of the accepted statutory categories (MPEP 2106.03).
Response to Arguments- 35 USC § 103
Applicant's arguments filed 04/23/2026 have been fully considered but they are not persuasive.
Applicant argues that no prior art teaches the target data set and actual data being based on separate and distinct subjects and that this is not taught by Alexander because Alexander allegedly only teaches the comparison of images of the same subject.
Examiner responds by explaining that the target and actual data sets being based on separate and distinct subjects is taught by the previously cited Korten reference. Specifically, Korten clearly teaches using a second, separate tooth as a reference tooth rather than take information from representations of the same tooth when describing the shade matching process ([Par 34] “Further the reference object may correspond to a model of another tooth of the patient's dentition which the dental restoration model is associated with.”)
While Alexander does teach the spectral distance comparison disclosed therein within the context of multiple depictions of the same subject, the technique disclosed is a generic technique for comparing color data and it would have been readily obvious to one of ordinary skill in the art that such a technique would work identically when applied to the two tooth data sets.
Further, as to the applicability of Alexander, firstly, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Secondly, the dental field and medical field are extremely intertwined, with dentistry merely being a medical care focused on a particular part of the body, i.e. the mouth. Further, there is extensive overlap between techniques between dentistry and general medicine, such as surgical techniques, imaging techniques and use of specialized equipment such as x-rays and MRIs, etc. The field of “medical procedures” is in no way non-analogous to that of dentistry.
Further, while Alexander does mention that the use of an overlay can help reduce glare, it clearly also describes overlaying different imagery to be able to judge differences between the imagery ([Page 64 line 6-9] “An adaptive response to the identification of blood occluding the view of the tissue of interest being operated on by the surgeon, would be the overlay of NIR imaging on the occluded areas of the visible imaging as depicted by FIG. 23 and described in detail below.” [Page 43 line 13-20] “. Examples of configuration parameters for configuring a user interface include, but not limited to, displayed windows, … selection of imaging modalities for overlay of images from two or more imaging modalities, and messages or warnings for the operator”) Especially, [Page 64 line 6-9] describes the use of the overlay as a way to get more detail on features occluded in one depiction but not the other, i.e. a way to do comparison between two sets of imagery.
It should be further noted that it is important for arguments about the content of cited references be directed to the cited reference itself and not a separate document that was not cited or referred to in the action. In arguments directed to the Alexander reference cited previously (CA 2902771 A1) the applicants repeatedly cite to another publication by the same inventors (US 9788906). While at first glance it appears that the two references are different versions of the same application submitted to different offices (CA 2902771 A1 being to the Canadian office and US 9788906 being to the US office), they use different formatting and line numberings (e.g. the col. 31 Lines 45-46 of US 9788906 argued in the remarks does not correspond to a col. 31 in CA 2902771 A1, which is not organized in columns in the first place.) Further, although at first glance the difference in formatting is the most apparent issue, these are different filings and it is automatically not guaranteed that the content of what they disclose is identical.
Applicant argues that no prior art teaches generating the digital tooth model as a three-dimensional tooth model with predefined internal architecture from a digital tooth library, which is then adapted to a given patient situation;
Examiner responds by explaining that this is taught by previously cited reference Esbech in combination with Elbaz
Particularly, Esbech teaches the use of a digital tooth library with predefined tooth architecture to generate tooth models and the subsequent modification of that library-derived tooth to patient specifications ([Par 152-153] “In step 531 a digital restoration design is created e.g. based on the shape data of a digital 3D representation of the patient's set of teeth and/or on template digital restoration design loaded from a library. Template digital restoration designs may e.g. be used when the tooth is broken. In step 532 the tooth shade values of different points or regions of the teeth are derived from the texture data of the digital 3D representation of the patient's set of teeth. From the derived tooth shade values or from tooth shade profiles created based on the derived tooth shade values a desired shade profile for the dental restoration can be determined.”)
Meanwhile, Elbaz teaches the inclusion of internal structure data in such a tooth database ([Col 28 line 23-27] “…any of the data captured by the intraoral scanner, i.e. a color 3D model combining the topography of the teeth lesions and internal teeth structure, may be maintained in a designated patient database for longitudinal monitoring and preservation of patient's oral health.”) While Elbaz’s database is not necessarily a ‘template’ database as disclosed in Esbech, it would have made the inclusion of internal tooth structure in such a tooth-structure database obvious to one of ordinary skill in the art.
Applicant argues that one of ordinary skill in the art would not have been motivated to combined Elbaz with the rest of the references.
Examiner responds by explaining that Elbaz is analogous art because it is within the field of dental modelling. It would have been obvious to one of ordinary skill in the art to combine it with Korten, Esbech, and Alexander before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to image the internal structure of the tooth more safely. As mentioned by Elbaz, being able to represent the internal structure teeth is extremely helpful to the preparation of dental procedures ([Col 1 line 47-60] “Many dental and orthodontic procedures can benefit from accurate three-dimensional (3D) descriptions of a patient's dentation and intraoral cavity. In particular, it would be helpful to provide a three-dimensional description of both the surface, and internal structures of the teeth, including the enamel and dentin, as well as caries and the general internal composition of the tooth volume. Although purely surface representations of the 3D surfaces of teeth have proven extremely useful in the design and fabrication of dental prostheses (e.g., crowns or bridges), and treatment plans, the ability to image internal structures including the development of caries and cracks in the enamel and underlying dentin, would be tremendously useful, particularly in conjunction with a surface topographical mapping.”) Elbaz notes, however, that typical methods of obtaining imagery of the internal structure of teeth involve the use of ionizing radiation, such as X-rays, which can have detrimental health effects and be costly to perform, highlight a need for a more cost-effective alternative not relying upon ionizing radiation ([Col 1 line 61- Col 2 line 15] “Historically, ionizing radiation (e.g., X-rays) have been used to image into the teeth. For example, X-Ray bitewing radiograms are often used to provide non-quantitative images into the teeth. However, in addition to the risk of ionizing radiation, such images are typically limited in their ability to show features and may involve a lengthy and expensive procedure to take. Other techniques, such as cone beam computed tomography (CBCT) may provide tomographic images, but still require ionizing radiation. Thus, it would be beneficial to provide methods and apparatuses, including devices and systems, such as intraoral scanning systems, that may be used to model a subject's tooth or teeth and include both external (surface) and internal (within the enamel and dentin) structures and composition using non-ionizing radiation. The model of the subject's teeth may be a 3D volumetric model or a panoramic image. In particular, it would be helpful to provide methods and apparatuses that may use a single apparatus to provide this capability. There is a need for improved methods and systems for scanning an intraoral cavity of a patient, and/or for automating the identification and analysis of dental caries.”) To this end, Elbaz presents a system for scanning teeth that captures both internal and external features of the teeth without the use of ionizing radiation ([Abstract] “Methods and apparatuses for generating a model of a subject's teeth. Described herein are intraoral scanning methods and apparatuses for generating a three-dimensional model of a subject's intraoral region (e.g., teeth) including both surface features and internal features. These methods and apparatuses may be used for identifying and evaluating lesions, caries and cracks in the teeth.” [Col 22 line 18-40] “For example, FIG. 1A illustrates one example of an intraoral scanner 101 that may be configured or adapted as described herein to generate 3D models having both surface and internal features. As shown schematically in FIG. 1B, an exemplary intraoral scanner may include a wand 103 that can be hand-held by an operator (e.g., dentist, dental hygienist, technician, etc.) and moved over a subject's tooth or teeth to scan both surface and internal structures. The wand may include one or more sensors 105 (e.g., cameras such as CMOS, CCDs, detectors, etc.) and one or more light sources 109, 110, 111. In FIG. 1B, three light sources are shown: a first light source 109 configured to emit light in a first spectral range for detection of surface features (e.g., visible light, monochromatic visible light, etc.; this light does not have to be visible light), a second color light source (e.g., white light between 400-700 nm, e.g., approximately 400-600 nm), and a third light source 111 configured to emit light in a second spectral range for detection of internal features within the tooth (e.g., by trans-illumination, small-angle penetration imaging, laser florescence, etc., which may generically be referred to as penetration imaging, e.g., in the near-IR “) Overall, one of ordinary skill in the art would have recognized that combining Korten, Esbech, and Alexander with Elbaz would result in a system that was capable of more safely capturing both the internal and external structures of teeth.
Further, that Elbaz is not exclusively directed specifically to a method that does dental shade matching in the exact same way as claimed for exactly the same purpose as the claimed invention does not mean that it is not usable as prior art; indeed, Elbaz teaches a dental scanning method that is significantly safer than other techniques and one of ordinary skill in the art would have been motivated to combine it with the previous references to enhance the tooth scanning system used to capture the target data set in the combination of Korten, Esbech, and Alexander. There is nothing in the disclosure of Korten, Esbech, and Alexander nor Elbaz that would suggest that the integration of the scanning features and additional digital tooth library features for which Elbaz is relied upon would require a fundamental change of principle of operation. Elbaz is not relied upon to teach defining a layered restoration architecture, appearance rendering, AE/spectral color deviation, nor iterative material architecture optimization and therefore arguments related to whether or not it sufficiently teaches these features are moot.
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 1, 6-12, and 14-18 are rejected under 35 U.S.C. 101 because they are directed to an abstract idea without significantly more.
Claim 1 (Statutory Category – Process)
Step 2A – Prong 1: Judicial Exception Recited?
Yes, the claim recites a mental process, specifically:
MPEP 2106.04(a)(2)(Ill): “Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, Judgments, and opinions.”
Further, the MPEP recites “The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation.”
A method for designing and producing a dental restoration (207), comprising the steps: … generating (S102) a digital tooth model (221) as a three-dimensional tooth model with predefined internal architecture from a digital tooth library, which is then adapted to a given patient situation; rendering (S103) the digital tooth model (221) based on the internal architecture to generate an actual data set (DS-I) that reflects the optical properties comprising the absorption coefficient, the scattering coefficient, the a refractive index and the geometry of the digital tooth model (221), wherein the target data set (DS-S) and the actual data set (DS-I) are based on separate and distinct subjects;
Generating, rendering, and creating a dataset from a model of a tooth is a mental process that is equivalent to imagining and then drawing a rendition of a tooth, as with a pencil and paper, and writing a representation of data that reflects the properties of the drawn tooth, such as a table of physical dimensions or a color value of the tooth in a particular region. This drawing could further be given 3D features such as drawing it in a perspective view or otherwise indicating the three-dimensional geometry of the model.
Specifying the use of particular optical properties merely clarifies what data is considered in the mental process of rendering the model. For example, materials with a high absorption coefficients may have a darker color than materials with lower absorption coefficients, materials with different scattering coefficients may have different reflective properties, etc. and could be drawn accordingly.
Obtaining the tooth data from the digital tooth library (i.e. a database) amounts to no more than mere data gathering, as analyzed below.
Doing this digitally in a true 3D rendering system merely amounts to mere instructions to apply this judicial exception on a generic computer.
calculating (S104) a deviation (AES,I) between the target data set (DS-S) and the actual data set (DS-I) by superimposing the target data set (DS-S) and the actual data set (DS-I);
“Calculating” a deviation by superimposing imagery and determining the difference between them is a mental process equivalent to observing the superimposed imagery and judging, based on the observation, an arbitrary deviation measure. For example, if a person observes the superimposed images and there does not seem to be any difference, they could decide that the deviation is “0.”
Should it be found that this is not a mental process, it is also an example of a mathematic process as analyzed below.
iteratively altering (S105),using a closed loop, the digital tooth model (221) to obtain a smaller deviation (AES,I) between the determined target data set (DS-S) and the actual data set (DS-I) of a re-rendered digital tooth model (221) until the deviation is at or below a specified threshold value;
Iteratively altering the model in such a manner is a mental process equivalent to repeatedly modifying and redrawing the tooth and its associated property representations until the properties of the drawn tooth more closely match the measured properties of a natural tooth, as obtained in the data gathering step explained below, by some arbitrarily chosen metric. For example, they could redraw the tooth until they both have the same scaled dimensions (i.e. the drawn tooth is exactly 10 times the height of the measured tooth.)
The claim also recites a mathematic process, specifically:
calculating (S104) a deviation (AES,I) between the target data set (DS-S) and the actual data set (DS-I) by superimposing the target data set (DS-S) and the actual data set (DS-I); wherein the deviation (AES,I) is calculated on the basis of a spectral distance between the target data set (DS-S) and the actual data set (DS-I), wherein the spectral distance is used to measure the difference in color information;
Calculating a deviation in such a manner by using a mathematic formula (i.e. calculating the numeric distance between the data sets) is a mathematic process, and therefore a mathematic concept.
Step 2A – Prong 2: Integrated into a Practical Solution?
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Mere Data Gathering:
determining (S101) a target data set (DS-S) based on a natural tooth (205), which reflects optical properties comprising an absorption coefficient, a scattering coefficient, and a refractive index and geometry of the natural tooth (205) with a digital camera, a 3D scanner, a 3D camera system, a spectrometer, or a digitized color key;
Determining this data by obtaining it in a generic manner from sensors such as digital cameras amounts to no more than mere data gathering.
generating (S102) a digital tooth model (221) as a three-dimensional tooth model with predefined internal architecture from a digital tooth library, which is then adapted to a given patient situation;
While the generation of model itself is a mental process as analyzed above, the obtaining of the data for generating it from a “digital tooth library” is equivalent to merely gathering that data in an unspecified manner; in other words, it amounts to no more than mere data gathering.
Post-solution activity:
producing the dental restoration (207) by a multi-material 3D printing device or a milling device wherein a limited range of materials is used and is sufficient to produce the dental restoration.
This element merely acts on and presents the results of the previous abstract steps, i.e. the generation of the model. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
That the system uses a limited range of materials that are sufficient to produce the dental restoration rather than an infinite number of materials that are incapable of forming the dental restoration, without the selection of such materials being a part of the process, is not sufficient to integrate the claims into a practical application.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A method for designing and producing a dental restoration (207), comprising the steps: … generating (S102) a digital tooth model (221) as a three-dimensional tooth model with predefined internal architecture from a digital tooth library, which is then adapted to a given patient situation; rendering (S103) the digital tooth model (221) based on the internal architecture to generate an actual data set (DS-I) that reflects the optical properties comprising the absorption coefficient, the scattering coefficient, the a refractive index and the geometry of the digital tooth model (221), wherein the target data set (DS-S) and the actual data set (DS-I) are based on separate and distinct subjects;
As explained above, creating this tooth model is a mental process. Specifying that it is a digital tooth model and performing this modeling in a true-3D renderer merely implements this mental process on a generic computer, and therefore amounts to no more than mere instructions to apply a judicial exception on a computer.
Step 2B: Claim provides an Inventive Concept?
No, as discussed with respect to Step 2A, the additional limitations are mere data gathering or post solution activity (Insignificant Extra-Solution Activity), or a general purpose computer and do not impose any meaningful limits on practicing the abstract idea and therefore the claim does not provide an inventive concept in Step 2B.
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Mere Data Gathering:
determining (S101) a target data set (DS-S) based on a natural tooth (205), which reflects optical properties comprising an absorption coefficient, a scattering coefficient, and a refractive index and geometry of the natural tooth (205) with a digital camera, a 3D scanner, a 3D camera system, a spectrometer, or a digitized color key;
Determining this data by obtaining it in a generic manner from sensors such as digital cameras amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
generating (S102) a digital tooth model (221) as a three-dimensional tooth model with predefined internal architecture from a digital tooth library, which is then adapted to a given patient situation;
While the generation of model itself is a mental process as analyzed above, the obtaining of the data for generating it from a “digital tooth library” is equivalent to merely gathering that data in an unspecified manner; in other words, it amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Post-solution activity:
producing the dental restoration (207) by a multi-material 3D printing device or a milling device wherein a limited range of materials is used and is sufficient to produce the dental restoration.
This element merely acts on and presents the results of the previous abstract steps, i.e. the generation of the model. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
That the system uses a limited range of materials that are sufficient to produce the dental restoration rather than an infinite number of materials that are incapable of forming the dental restoration, without the selection of such materials being a part of the process, is not sufficient to integrate the claims into a practical application.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A method for designing and producing a dental restoration (207), comprising the steps: … generating (S102) a digital tooth model (221) as a three-dimensional tooth model with predefined internal architecture from a digital tooth library, which is then adapted to a given patient situation; rendering (S103) the digital tooth model (221) based on the internal architecture to generate an actual data set (DS-I) that reflects the optical properties comprising the absorption coefficient, the scattering coefficient, the a refractive index and the geometry of the digital tooth model (221), wherein the target data set (DS-S) and the actual data set (DS-I) are based on separate and distinct subjects;
As explained above, creating this tooth model is a mental process. Specifying that it is a digital tooth model and performing this modeling in a true-3D renderer merely implements this mental process on a generic computer, and therefore amounts to no more than mere instructions to apply a judicial exception on a computer.
See (MPEP 2106.05(f)(2) “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit) … TLI Communications provides an example of a claim invoking computers and other machinery merely as a tool to perform an existing process. The court stated that the claims describe steps of recording, administration and archiving of digital images, and found them to be directed to the abstract idea of classifying and storing digital images in an organized manner. 823 F.3d at 612, 118 USPQ2d at 1747. The court then turned to the additional elements of performing these functions using a telephone unit and a server and noted that these elements were being used in their ordinary capacity (i.e., the telephone unit is used to make calls and operate as a digital camera including compressing images and transmitting those images, and the server simply receives data, extracts classification information from the received data, and stores the digital images based on the extracted information). 823 F.3d at 612-13, 118 USPQ2d at 1747-48. In other words, the claims invoked the telephone unit and server merely as tools to execute the abstract idea. Thus, the court found that the additional elements did not add significantly more to the abstract idea because they were simply applying the abstract idea on a telephone network without any recitation of details of how to carry out the abstract idea. i. A commonplace business method or mathematical algorithm being applied on a general purpose computer,” [Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S. 208, 223, 110 USPQ2d 1976, 1983 (2014); Gottschalk v. Benson, 409 U.S. 63, 64, 175 USPQ 673, 674 (1972); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); … v. Requiring the use of software to tailor information and provide it to the user on a generic computer, Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1370-71, 115 USPQ2d 1636, 1642 (Fed. Cir. 2015); )
In addition, the following are also considered as well-understood, routine, and conventional activities, as discussed in MPEP § 2106.05(d):
producing the dental restoration (207) by a multi-material 3D printing device or a milling device wherein a limited range of materials is used and is sufficient to produce the dental restoration.
is a well-understood, routine, and conventional activity, as evidenced by:
How Dental Dentures are Made ([Page 2 Par 5-6])
Current status and applications of additive manufacturing in dentistry: A literature-based review ([Abstract, Page 179 Col 1 Par 1 – Col 2 Par 2, Page 180 Col 1 Par 6-12, Page 180 Col 2 Par 5, Table 1])
Applications of 3D Printing in Dentistry – A Review ([Abstract, Page 1671 Col 1 Par 4, Page 1672 Col 2 Par 3-4])
3D Printing and Digital Processing Techniques in Dentistry: A Review of Literature ([Abstract, Page 1 Col 1 Par 1-2])
An update on applications of 3D printing technologies used for processing polymers used in implant dentistry ([Abstract, Page 336 Col 2 Par 2])
Moreover, Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “digital dental model; a digital camera, a 3D scanner, a 3D camera system, a spectrometer, or a digitized color key; a digital tooth library;” are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 14 The elements of claim 14 are substantially the same as those of claim 1. Therefore, the elements of claim 14 are rejected due to the same reasons as outlined above for claim 1.
Moreover, Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “A computer apparatus (200) for designing a dental restoration (207), comprising a sensor (203) for detecting a target data set based on a natural tooth; a generation unit; a generation unit for generating (S102) a digital tooth model (221) a digital tooth library; a rendering unit; a calculation unit; an altering unit;” are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 6 recites “The method according to claim 1, wherein the target data set (DS-S) comprises optical properties of a residual tooth (209).”
This merely clarifies what type of tooth the data for the target data set is gathered from, and is therefore merely an extension of the data gathering step.
Claim 7 recites “The method according to claim 6, wherein the digital tooth model (221) is rendered on the basis of the optical properties of the residual tooth (209), geometry of the residual tooth, one or more surrounding neighboring teeth, an oral situation, a consideration of the gingiva or gum color and/or an adhesive material used for fixing the dental restoration (207) on the residual tooth (209).”
This merely clarifies what data the rendered model is based on, and is therefore merely an extension of the mental process and mere instructions to apply the judicial exception of rendering it.
Claim 8 recites “The method according to claim 1, wherein the step of generating the digital tooth model (221) comprises the step of importing, calculating and/or specifying a tooth model having a predetermined internal architecture.”
Importing data, i.e. loading data from memory is explicitly recognized by the courts as well-understood, routine, conventional activity (MPEP 2106.05(d)(II)(iv) Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;)
Calculating is a mathematic process, and therefore calculating the form of the tooth model is mathematic concept.
Finally, “specifying” the tooth model is a mental process equivalent to drawing a model of a tooth with a pencil and paper. This drawing could further be given features to indicate the three-dimensional nature of the model. Further, implementing this digitally in a true 3D rendering capacity amounts to no more than mere instructions to apply this mental process using a general purpose computer.
Claim 9 recites “The method according to claim 1, wherein the digital tooth model (221) is rendered at an angle that corresponds to a shooting angle when capturing the natural tooth (205) and/or a predetermined light situation.”
This merely clarifies the perspective from which the tooth model should be drawn, and is therefore merely an extension of the mental process and mere instructions to apply the judicial exception of rendering it.
Claim 10 recites “The method according to claim 1, wherein the digital tooth model (221) is altered by changing a material assignment to a sub-volume.”
Changing the assigned material of a part of the tooth model is a mental process that is equivalent to noting the material of that region, such as by writing the name of the chosen material with an arrow pointing to the region on the drawing.
Claim 11 recites “The method according to claim 1, wherein the digital tooth model (221) is altered by changing a sub-volume while retaining an outer geometry.”
This merely amounts to a mental process equivalent to redrawing the inside of the tooth while keeping the original outline the same.
Claim 12 recites “The method according to claim 1, wherein the dental restoration (207) is fabricated based on the actual data set (DS-I).”
This merely clarifies what data set is used when fabrication the restoration, and is therefore merely an extension of the post-solution activity.
Claim 15 recites “A computer apparatus (200) for designing a dental restoration (207) comprising a sensor (203) for detecting a target data set based on a natural tooth and a computing device with at least one algorithm that is configured to perform the method of claim 1.”
This claim merely recites a generic computer on which to implement the judicial exception steps of claim 1, and therefore amounts to not more than mere instructions to apply the judicial exception on a computer.
Claim 16 recites “A computer program comprising instructions that cause a computer device comprising a sensor (203) for detecting a target data set based on a natural tooth, to perform the process steps according to claim 1.”
See rejection of claim 16 below regarding the claim being directed to non-statutory subject matter.
Claim 17 recites “A computer program product comprising program code which is stored on a non-transitory machine-readable medium, the machine-readable medium comprising computer instructions executable by a processor, which computer instructions cause the processor to perform the method according to claim 1.”
This claim merely recites generic computer components on which to implement the judicial exception steps of claim 1, and therefore amounts to not more than mere instructions to apply the judicial exception on a computer.
Claim 18 recites “wherein the sensor (203) comprises a digital camera, a 3D scanner, a 3D camera system, a spectrometer, or a digitized color key.”
This element merely specifies the form of the sensor used for obtaining the target data and is therefore merely an extension of the mental process and mere data gathering steps.
Further, regarding claim 16, the claim(s) are directed to a “computer program.” Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations are not directed to any of the statutory categories (MPEP 2106.03).
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.
(1) Claims 1, 6-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Korten (US 20140372085 A1) in view of Esbech (US 20180153664 A1) in further view of Alexander (CA 2902771 A1) as well as Elbaz (US 10606911 B2)
Claim 1. Korten makes obvious A method for designing and producing a dental restoration (207), comprising the steps: ([Par 12] “The invention in one aspect relates to a method of making a dental restoration”) determining (S101) a target data set (DS-S) based on a natural tooth (205), which reflects optical properties ([Par 59] “… may be scanned, for example using an optical digital scanner, for providing a computer model of the patient's dentition, and/or a computer model of a particular tooth structure, like the tooth stump of the tooth to be restored 11. Such a scanner is for example available under the designation Lava.TM. Scan ST or Lava.TM. C.O.S., from 3M ESPE AG, Germany. The skilled person will recognize several alternative ways for providing a computer model of a tooth structure. For example the tooth structure may be directly scanned in the patient's mouth for providing a tooth structure model, or the tooth structure may be scanned from the dental impression and inverted. Further the tooth structure may be designed using a dental CAD system.” [Par 48] “The system is adapted for visualizing a three-dimensional reference surface that is based on a shape of at least one of a tooth structure of a tooth to be restored in a patient's dentition, and a dental restoration for the tooth.”) with a digital camera, a 3D scanner, ([Par 5] “capturing the shape of a patient's teeth, for example by scanning a plaster model of the patient's teeth or alternatively by scanning the actual teeth in the patient's mouth;” [Par 59] “… may be scanned, for example using an optical digital scanner, for providing a computer model of the patient's dentition, and/or a computer model of a particular tooth structure, like the tooth stump of the tooth to be restored 11. Such a scanner is for example available under the designation Lava.TM. Scan ST or Lava.TM. C.O.S., from 3M ESPE AG, Germany.”) a 3D camera system, a spectrometer, or a digitized color key; generating (S 102) a digital tooth model (221) as a three-dimensional model with predefined internal architecture ([Fig. 5] Shows a CAD designed tooth restoration model including internal structures rendered in a software window [Fig. 3] Shows another designed digital restoration model [Par 63] “FIG. 3 shows a computer model 30 of the dental restoration. The dental restoration model 30 is defined between a computer simulated tooth-facing surface 31 and a computer simulated outer dental restoration surface 32. The tooth-facing surface 31 may at least partially correspond in shape to the tooth structure model obtained from the shape of the patient's dentition. Accordingly the tooth structure model may be used to generate the tooth-facing surface of the dental restoration” [Par 40] “In a further embodiment the method further comprises the step of providing a computer model of the dental restoration based on the tooth structure model. The dental restoration model may be provided in the form of data which are suitable to define the shape and the color of the dental restoration.” [Par 38] “ Further in one embodiment the method comprises the step of directly or indirectly assigning at least one of the plurality of layers with a translucency/opacity, fluorescence and/or with a refractive index. Thus the dental restoration may not only be provided with different desired colors but further with different desired translucencies/opacities, fluorescences and/or refractive indices.”)
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wherein the target data set (DS-S) and the actual data set (DS-I) are based on separate and distinct subjects; ([Par 34] “Further the reference object may correspond to a model of another tooth of the patient's dentition which the dental restoration model is associated with.”) calculating (S104) a deviation (AES,I) between the target data set (DS-S) and the actual data set (DS-I) ([Par 34] “For example based on the comparison the user may determine a difference of the color of the dental restoration model relative to the reference object”) ([Par 34] “In one embodiment the method further comprises the step of visualizing a reference object which exhibits a reference color.”) and the actual data set (DS-I); ([Par 33] “In one embodiment the method comprises the step of visualizing the dental restoration model”) wherein the deviation (AES,I) is calculated ([Par 34] “For example based on the comparison the user may determine a difference of the color of the dental restoration model relative to the reference object”) ([Par 34] “In one embodiment the method further comprises the step of visualizing a reference object which exhibits a reference color.”) and the actual data set (DS-I), ([Par 33] “In one embodiment the method comprises the step of visualizing the dental restoration model”) wherein the ([Par 34] “… A difference in colors between the dental restoration model and the reference object may further be visualized in the form of data, for example in the form the so-called "Delta E" value.”) iteratively altering (S105), using a closed loop, the digital tooth model (221) to obtain a smaller deviation (AES,I) between the determined target data set (DS-S) and the actual data set (DS-I) of a re-rendered digital tooth model (221) until the deviation is at or below a specified threshold value; ([Par 34] “For example based on the comparison the user may determine a difference of the color of the dental restoration model relative to the reference object, and change a color of a layer of the dental restoration model accordingly to generally compensate such a difference. Such comparison and change of color may be repeated until the desired color of a layer or the resulting tooth color is reached. A difference in colors between the dental restoration model and the reference object may further be visualized in the form of data, for example in the form the so-called "Delta E" value.”)
Korten does not explicitly teach obtaining optical properties comprising an absorption coefficient, a scattering coefficient, and a refractive index; obtaining tooth data with predefined internal architecture from a digital tooth library, which is then adapted to a given patient situation; a model with optical properties comprising the absorption coefficient, the scattering coefficient and the refractive index; obtaining information by superimposing data on other data; obtaining a difference between data on the basis of a spectral distance between first and second data elements wherein the spectral distance is used to measure difference in color information; producing the dental restoration (207) by a multi-material 3D printing device or a milling device wherein a limited range of materials is used and is sufficient to produce the dental restoration.
Esbech makes obvious obtaining tooth data with predefined ([Par 152-153] “In step 531 a digital restoration design is created e.g. based on the shape data of a digital 3D representation of the patient's set of teeth and/or on template digital restoration design loaded from a library. Template digital restoration designs may e.g. be used when the tooth is broken. In step 532 the tooth shade values of different points or regions of the teeth are derived from the texture data of the digital 3D representation of the patient's set of teeth. From the derived tooth shade values or from tooth shade profiles created based on the derived tooth shade values a desired shade profile for the dental restoration can be determined.”) ([Par 20] “In many cases, the dental restoration is manufactured with a shade profile … Multi-shaded milling blocks exits which mimics standard tooth shade profiles. Having the shape data and the tooth shade values linked via the digital 3D representation provides that the correct portion of the multi-shaded milling block can be milled out.”)
Esbech is analogous art because it is within the field of dental restoration planning. It would have been obvious to one of ordinary skill in the art to combine it with Korten before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to better color designed dental restorations to match the patient’s other teeth. As explained by Esbech ([Par 3] “When designing and manufacturing a dental restoration for a patient, such as a crown or a bridge restoration, it is advantageous that both the shape and shade of the manufactured restoration is adapted to the patient's natural teeth surrounding the restoration. If the shade of the restoration differs significantly from the surrounding natural teeth, e.g. is significantly darker or brighter than these, the restoration appear artificial and deteriorate the aesthetic impression of the patient's smile.”) To this end, Esbech presents a system that determines an accurate shade of a patient’s tooth so restorations can be made to more closely match the patient’s surrounding teeth ([Par 8-10] “Disclosed is a method for determining shade of a patient's tooth, wherein the method comprises: obtaining a digital 3D representation of the tooth, where the digital 3D representation comprises shape data and texture data for the tooth; and determining a tooth shade value for at least one point on the tooth based on the texture data of the corresponding point of the digital 3D representation and on known texture values of one or more reference tooth shade values.” [Par 20] “In many cases, the dental restoration is manufactured with a shade profile where the shade differs from the incisal edge towards cervical end of the restoration. The disclosed invention allows the operator to determine tooth shade values for several points on the tooth such that a shade profile can be determined for the dental restoration. Multi-shaded milling blocks exits which mimics standard tooth shade profiles. … The remaining portion of the multi-shaded milling block forming the dental restoration will then have a shape and shade profile which closely resembles that of a natural tooth.”) Overall, one of ordinary skill in the art would have recognized that combining Esbech with Korten would result in a system that allowed the design of more natural looking dental restorations that better matched the rest of the patient’s teeth.
The combination of Korten and Esbech does not explicitly teach obtaining optical properties comprising an absorption coefficient, a scattering coefficient, and a refractive index; tooth data with predefined internal architecture from a digital tooth library; a model with optical properties comprising the absorption coefficient, the scattering coefficient and the refractive index; obtaining information by superimposing data on other data; obtaining a difference between data on the basis of a spectral distance between first and second data elements wherein the spectral distance is used to measure difference in color information;
Alexander makes obvious ([Page 36 line 4-8] “In one mode, images can be acquired by sweeping through the different image acquisition modes to provide multiple serially obtained (e.g. almost simultaneously obtained) images of different types which can be combined into an overlaid representation and displayed to the operator.” [Page 73 line 18-23] “The additional images from the second imaging modality may be displayed according to a wide variety of different configurations, such as displaying the images from the first and second imaging modalities in a side-by-side configuration or in an overlaid configuration (optionally after having registered the images from the first imaging modality with those of the second imaging modality).” [Page 64 line 6-9] “An adaptive response to the identification of blood occluding the view of the tissue of interest being operated on by the surgeon, would be the overlay of NIR imaging on the occluded areas of the visible imaging as depicted by FIG. 23 and described in detail below.” [Page 43 line 13-20] “. Examples of configuration parameters for configuring a user interface include, but not limited to, displayed windows, … selection of imaging modalities for overlay of images from two or more imaging modalities, and messages or warnings for the operator) obtaining a difference between data on the basis of a spectral distance between first and second data elements wherein the spectral distance is used to measure difference in color information; ([Page 54 line 12 – Page 55 line 4] “It will be understood that the spectral data may be provided … as discrete values a small set of wavelengths or wavelength bands, such as red-green-blue intensity data. Pixels with similar spectral content may be identified based on the calculation of a spectral similarity measure between adjacent pixels. For example, a spectral similarity measure for two pixels may be calculated by summing, over all wavelengths, the square of the difference 25 between the values of the two intensity spectra (optionally after initially normalizing the two spectra), and dividing the result by the square of the average net intensity (summed over all wavelength values) of the two pixels. In such a case, two pixels may be deemed to have similar spectral responses if their spectral similarity measure is less than a pre-selected threshold value.” [Page 64 line 6-11] “An adaptive response to the identification of blood occluding the view of the tissue of interest being operated on by the surgeon, would be the overlay of NIR imaging on the occluded areas of the visible imaging as depicted by FIG. 23 and described in detail below. It should be noted that the context parameter used to identify the blood, would be its visible wavelength (color) spectrum.” [Examiner’s note: the “intensity spectra” disclosed describe color data. “Spectral similarity” is another term for spectral distance, and thus determining the spectral similarity between intensity spectra is equivalent to determining the spectral distance between color data])
Alexander is analogous art because it is within the field of medical data processing with a particular application in medical imagery processing. It would have been obvious to one of ordinary skill in the art to combine Alexander with Korten and Esbech before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to make the restoration procedure using the designed restoration more time efficient and easier for the dentist/surgeon to perform. As noted by Esbech, manual preparation of medical procedures can be slow and inaccurate ([Par 7] “When manually determining which reference tooth shade value best matches the color of a patient's tooth, the dentist holds different pre-manufactured teeth of the shade guide at the tooth for comparison. Often a picture is taken with the pre-manufactured structures arranged at the teeth. The technician who produces the prosthetic then uses the picture in evaluating which ceramic must be used for the different parts of the restoration based on the picture. This process is both time consuming and inaccurate.”) To this end, Alexander presents a method to streamline many aspects of such procedures, including the automation of imagery and color acquisition and processing as well as automated adaptation of the user-interface used by medical professionals for the task at hand ([Page 62 Par 1-5] “In each stage there are applicable adaptive processes that can run to streamline the procedure to provide more accurate and time efficient surgical procedures” [Page 68 Par 1] “analyzed to automatically obtain a measures associated with color balance, white balance, dynamic range and illumination uniformity (spatial uniformity)… Item (120) is a white balance feature in which the processing system analyzes the image and uses this feature as the "true" white color, it can then adjust its configuration parameters such as its color mapping to confirm that the white it depicts is the same white as the calibration feature. Item (122) is a grey scale balance calibration feature used in a similar manner to the one described above for adjusting the imaging device configuration to match this grey balance range. Item (134) is an RGB color balance calibration feature. The imaging device when oriented to view down the port to the distal end can use these calibration features in the imaging focus periphery to obtain the optimal image for the surgery.” [Page 36 line 4-8] “In one mode, images can be acquired by sweeping through the different image acquisition modes to provide multiple serially obtained (e.g. almost simultaneously obtained) images of different types which can be combined into an overlaid representation and displayed to the operator.” [Page 47 Par 2] “The configuration parameters that are associated with the one or more medical instruments may enable the automated re-configuration of the user interface based on the identification of one or more medical instruments. Examples of configuration parameters for configuring a user interface include, but not limited to, displayed windows, displayed icons, colors, one or more displayed or displayable menu items, intensity of one or more displayed items, relative size of displayed windows, relative positioning of one or more windows, display of images from one or more imaging modalities” [Page 22 line 1-5] “…may be employed for a wide range of medical procedures. Examples of other types of medical procedures including orthopedic, trauma, gastrological, … oral and maxillofacial, …, dental, and other surgical, diagnostic or therapeutic medical procedures.”) Overall, one of ordinary skill in the art would have recognized that combining Alexander with Korten and Esbech would result in a significantly more automated system that allows the restoration to be implemented faster and with more precision.
The combination of Korten, Esbech, and Alexander does not explicitly teach obtaining optical properties comprising an absorption coefficient, a scattering coefficient, and a refractive index; tooth data with predefined internal architecture from a digital tooth library; a model with optical properties comprising the absorption coefficient, the scattering coefficient and the refractive index;
Elbaz makes obvious obtaining optical properties comprising an absorption coefficient, a scattering coefficient, and a refractive index; ([Col 29 line 40-54] “In general, in any of the apparatuses and methods described herein, the internal feature data collected 605 may be used to reconstruct a volumetric model of the tooth or teeth including the internal features. In particular, tomographic reconstruction (e.g., optical tomography) may be used. A fully volumetric modeling may be used. Typically, every penetrating light ray can either be refracted, reflected, scattered and/or absorbed (including combinations of these), depending on the material properties and the light used. In some variation, the methods and/or apparatus may divide the volume of the tooth into small voxels and for each voxel, estimate these four parameters (refraction index, reflection, scattering, absorption) based on the imaging data collected, using the coordinate system corresponding to the coordinate system of the surface data.” [Col 39 line 26- 32] “For example, the methods described herein can further include receiving surface data representing an exterior surface of the object (e.g., scan data representing an exterior or enamel surface of a tooth). With the exterior surface data, only points within this exterior surface (e.g., internal points) can be used to generate scattering coefficients.” [Col 41 line 16-31] “Back propagation may include estimating (e.g., tracing) rays going through the tooth volume and entering the camera. The actual intensities reaching the sensor for each ray may be taken from the penetrative images and camera positions and orientations. For each ray the damping of the intensity due to scattering in the volume it passes may be estimated. For example, the transmission of light through a strongly scattering and weakly absorbing material may be modeled using a hybrid calculation scheme of scattering by the Monte Carlo method to obtain the temporal variation of transmittance of the light through the material. A set of projection data may be estimated by temporally extrapolating the difference in the optical density between the absorbing object and a non-absorbing reference to the shortest time of flight. This technique may therefore give a difference in absorption coefficients.” [Examiner’s note: these passages describe the generation of a model from scan data taking into account an absorption coefficient, scattering coefficient, and a refractive index. Col 39 line 26-32 and Col 41 line 16-31 further describe the determination of the scattering and absorption coefficients, respectively]) tooth data with predefined internal architecture from a digital tooth library; ([Col 28 line 23-27] “…any of the data captured by the intraoral scanner, i.e. a color 3D model combining the topography of the teeth lesions and internal teeth structure, may be maintained in a designated patient database for longitudinal monitoring and preservation of patient's oral health.”)a model with optical properties comprising the absorption coefficient, the scattering coefficient and the refractive index; ([Col 29 line 40-54] “In general, in any of the apparatuses and methods described herein, the internal feature data collected 605 may be used to reconstruct a volumetric model of the tooth or teeth including the internal features. In particular, tomographic reconstruction (e.g., optical tomography) may be used. A fully volumetric modeling may be used. Typically, every penetrating light ray can either be refracted, reflected, scattered and/or absorbed (including combinations of these), depending on the material properties and the light used. In some variation, the methods and/or apparatus may divide the volume of the tooth into small voxels and for each voxel, estimate these four parameters (refraction index, reflection, scattering, absorption) based on the imaging data collected, using the coordinate system corresponding to the coordinate system of the surface data.” [Col 39 line 26- 32] “For example, the methods described herein can further include receiving surface data representing an exterior surface of the object (e.g., scan data representing an exterior or enamel surface of a tooth). With the exterior surface data, only points within this exterior surface (e.g., internal points) can be used to generate scattering coefficients.” [Col 41 line 16-31] “Back propagation may include estimating (e.g., tracing) rays going through the tooth volume and entering the camera. The actual intensities reaching the sensor for each ray may be taken from the penetrative images and camera positions and orientations. For each ray the damping of the intensity due to scattering in the volume it passes may be estimated. For example, the transmission of light through a strongly scattering and weakly absorbing material may be modeled using a hybrid calculation scheme of scattering by the Monte Carlo method to obtain the temporal variation of transmittance of the light through the material. A set of projection data may be estimated by temporally extrapolating the difference in the optical density between the absorbing object and a non-absorbing reference to the shortest time of flight. This technique may therefore give a difference in absorption coefficients.” [Examiner’s note: these passages describe the generation of a model from scan data taking into account an absorption coefficient, scattering coefficient, and a refractive index. Col 39 line 26-32 and Col 41 line 16-31 further describe the determination of the scattering and absorption coefficients, respectively]))
Elbaz is analogous art because it is within the field of dental modelling. It would have been obvious to one of ordinary skill in the art to combine it with Korten, Esbech, and Alexander before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to image the internal structure of the tooth more safely. As mentioned by Elbaz, being able to represent the internal structure teeth is extremely helpful to the preparation of dental procedures ([Col 1 line 47-60] “Many dental and orthodontic procedures can benefit from accurate three-dimensional (3D) descriptions of a patient's dentation and intraoral cavity. In particular, it would be helpful to provide a three-dimensional description of both the surface, and internal structures of the teeth, including the enamel and dentin, as well as caries and the general internal composition of the tooth volume. Although purely surface representations of the 3D surfaces of teeth have proven extremely useful in the design and fabrication of dental prostheses (e.g., crowns or bridges), and treatment plans, the ability to image internal structures including the development of caries and cracks in the enamel and underlying dentin, would be tremendously useful, particularly in conjunction with a surface topographical mapping.”) Elbaz notes, however, that typical methods of obtaining imagery of the internal structure of teeth involve the use of ionizing radiation, such as X-rays, which can have detrimental health effects and be costly to perform, highlight a need for a more cost-effective alternative not relying upon ionizing radiation ([Col 1 line 61- Col 2 line 15] “Historically, ionizing radiation (e.g., X-rays) have been used to image into the teeth. For example, X-Ray bitewing radiograms are often used to provide non-quantitative images into the teeth. However, in addition to the risk of ionizing radiation, such images are typically limited in their ability to show features and may involve a lengthy and expensive procedure to take. Other techniques, such as cone beam computed tomography (CBCT) may provide tomographic images, but still require ionizing radiation. Thus, it would be beneficial to provide methods and apparatuses, including devices and systems, such as intraoral scanning systems, that may be used to model a subject's tooth or teeth and include both external (surface) and internal (within the enamel and dentin) structures and composition using non-ionizing radiation. The model of the subject's teeth may be a 3D volumetric model or a panoramic image. In particular, it would be helpful to provide methods and apparatuses that may use a single apparatus to provide this capability. There is a need for improved methods and systems for scanning an intraoral cavity of a patient, and/or for automating the identification and analysis of dental caries.”) To this end, Elbaz presents a system for scanning teeth that captures both internal and external features of the teeth without the use of ionizing radiation ([Abstract] “Methods and apparatuses for generating a model of a subject's teeth. Described herein are intraoral scanning methods and apparatuses for generating a three-dimensional model of a subject's intraoral region (e.g., teeth) including both surface features and internal features. These methods and apparatuses may be used for identifying and evaluating lesions, caries and cracks in the teeth.” [Col 22 line 18-40] “For example, FIG. 1A illustrates one example of an intraoral scanner 101 that may be configured or adapted as described herein to generate 3D models having both surface and internal features. As shown schematically in FIG. 1B, an exemplary intraoral scanner may include a wand 103 that can be hand-held by an operator (e.g., dentist, dental hygienist, technician, etc.) and moved over a subject's tooth or teeth to scan both surface and internal structures. The wand may include one or more sensors 105 (e.g., cameras such as CMOS, CCDs, detectors, etc.) and one or more light sources 109, 110, 111. In FIG. 1B, three light sources are shown: a first light source 109 configured to emit light in a first spectral range for detection of surface features (e.g., visible light, monochromatic visible light, etc.; this light does not have to be visible light), a second color light source (e.g., white light between 400-700 nm, e.g., approximately 400-600 nm), and a third light source 111 configured to emit light in a second spectral range for detection of internal features within the tooth (e.g., by trans-illumination, small-angle penetration imaging, laser florescence, etc., which may generically be referred to as penetration imaging, e.g., in the near-IR “) Overall, one of ordinary skill in the art would have recognized that combining Korten, Esbech, and Alexander with Elbaz would result in a system that was capable of more safely capturing both the internal and external structures of teeth.
Claim 6. Korten makes obvious The method according to claim 1, wherein the target data set (DS-S) comprises optical properties of a residual tooth (209). ([Par 39] “In one embodiment the method further comprises the step of providing a computer model of the tooth structure of the tooth or teeth to be restored. Such a tooth structure may relate to a tooth stump, a dental implant, or a dental abutment. The computer model of the tooth structure may accordingly comprise a representation of a three-dimensional outer surface of the tooth stump, the implant, or the abutment.”)
Claim 7. Korten makes obvious The method according to claim 6, wherein the digital tooth model (221) is rendered ([Fig. 5] Shows a digital tooth model rendered in a software window) on the basis of the optical properties of the residual tooth (209), geometry of the residual tooth, one or more surrounding neighboring teeth, ([Par 39] “In one embodiment the method further comprises the step of providing a computer model of the tooth structure of the tooth or teeth to be restored. Such a tooth structure may relate to a tooth stump, a dental implant, or a dental abutment. The computer model of the tooth structure may accordingly comprise a representation of a three-dimensional outer surface of the tooth stump, the implant, or the abutment. The tooth structure may be complemented by the dental restoration to a single restored tooth, for example may be complemented by a dental crown, or may be complemented by the dental restoration to two or more restored teeth, for example a dental bridge. Further the tooth structure may comprise at least two tooth stumps, implants, abutments or combinations thereof, for example for fixing a dental bridge thereon.”) an oral situation, ([Par 40] “The outer dental restoration surface may be provided by using a standard tooth model from a database holding a plurality of standard tooth shapes that may be modified to fit with the geometric constraints and requirements of a particular clinical situation in a patient's mouth.”) a consideration of the gingiva or gum color and/or an adhesive material used for fixing the dental restoration (207) on the residual tooth (209). ([Par 74] “The dental framework model 101 has a computer simulated tooth-facing surface 101a and a computer simulated veneer-facing surface 101b… The enlargement relative to the shape of the stump provides for a gap between the stump and the finished framework for accommodating a bonding material, for example a dental cement, for affixing the finished framework to the stump.”)
Claim 8. Korten makes obvious The method according to claim 1, wherein the step of generating the digital tooth model (221) comprises the step of importing, calculating and/or specifying a tooth model having a predetermined internal architecture. ([Par 8] “Then, a digital three-dimensional representation of the external surface of the cap is defined on the basis of the external and internal surfaces of the prosthesis.” [Par 64] “Such a standard tooth shape may for example be selected from a database storing a plurality of standard tooth shapes in the form of computer surface models.”)
Claim 9. Korten makes obvious The method according to claim 1, wherein the digital tooth model (221) is rendered at an angle that corresponds to a shooting angle when capturing the natural tooth (205) and/or a predetermined light situation. ([Par 32] “Further the dental restoration model and/or the model of one or more neighboring teeth may be visualized at different illuminations, for example illuminated from different perspectives and/or by use of different light sources (point or surface light).”)
Claim 10. Korten makes obvious The method according to claim 1, wherein the digital tooth model (221) is altered by changing a material assignment to a sub-volume. ([Par 42] “In a preferred embodiment the method further comprises the steps of providing the dental restoration model comprised of a plurality of layers of which at least two are assigned different colors, for example the dental restoration model may be entirely comprised of the plurality of layers. This preferably allows the making of the dental restoration monolithically out of generally the same type of material color shaded to resemble a natural tooth or teeth. For example the dental restoration may be made entirely of differently colored ceramic material or glass ceramic material.” [Par 69] “The CAD system may be adapted such that the cursor can be positioned within the dental veneer model 34 and used to deposit a virtual material layer of a defined color and size. Preferably each of the material color, thickness and size is user selectable, for example from a computer menu displaying discrete predefined tooth colors or from a discrete or continuous color palette.”)
Claim 11. Korten makes obvious The method according to claim 1, wherein the digital tooth model (221) is altered by changing a sub-volume while retaining an outer geometry. ([Par 26] “On the other hand the dental restoration may be colored without affecting the outer geometry of the dental restoration or the geometry of the dental framework, for example” [Par 42] “In a preferred embodiment the method further comprises the steps of providing the dental restoration model comprised of a plurality of layers of which at least two are assigned different colors, for example the dental restoration model may be entirely comprised of the plurality of layers. This preferably allows the making of the dental restoration monolithically out of generally the same type of material color shaded to resemble a natural tooth or teeth. For example the dental restoration may be made entirely of differently colored ceramic material or glass ceramic material.”)
Claim 12. Korten makes obvious The method according to claim 1, wherein the dental restoration (207) is fabricated based on the actual data set (DS-I). ([Par 47] “In a further embodiment the method comprises the step of manufacturing the dental restoration based on the dental restoration model and the layers the dental restoration model comprises. The method may further comprise the step of providing shape and color information of the dental restoration in the form of manufacturing data to a manufacturing machine. A suitable manufacturing machine may for example be a build-up or rapid prototyping machine which may allow for building up the dental restoration, or a precursor thereof, according to the shape and colors defined in the manufacturing data.”)
Claim 14. The elements of claim 14 are substantially the same as those of claim 1. Therefore, the elements of claim 14 are rejected due to the same reasons as outlined above for claim 1.
Further, Korten makes obvious the additional elements of “A computer apparatus (200) for designing a dental restoration (207), comprising a sensor (203) for detecting a target data set based on a natural tooth, ([Par 12] “The invention in one aspect relates to a method of making a dental restoration” [Par 5] “capturing the shape of a patient's teeth, for example by scanning a plaster model of the patient's teeth or alternatively by scanning the actual teeth in the patient's mouth;” [Par 59] “… may be scanned, for example using an optical digital scanner, for providing a computer model of the patient's dentition, and/or a computer model of a particular tooth structure, like the tooth stump of the tooth to be restored 11. … The skilled person will recognize several alternative ways for providing a computer model of a tooth structure. For example the tooth structure may be directly scanned in the patient's mouth for providing a tooth structure model, or the tooth structure may be scanned from the dental impression and inverted. Further the tooth structure may be designed using a dental CAD system.” [Par 48] “The system is adapted for visualizing a three-dimensional reference surface that is based on a shape of at least one of a tooth structure of a tooth to be restored in a patient's dentition, and a dental restoration for the tooth.”
Claim 15. Esbech makes obvious A computer apparatus (200) for designing a dental restoration (207) comprising a sensor (203) for detecting a target data set based on a natural tooth and a computing device ([Par 164] FIG. 6 shows a schematic of a system for determining tooth shade values. The system 640 comprises a computer device 642 comprising a computer readable medium 643 and a processor 644. The system further comprises a visual display unit 647, a computer keyboard 645 and a computer mouse 646 for entering data and activating virtual buttons in a user interface visualized on the visual display unit 647. The visual display unit can be a computer screen. The computer device 642 is capable of receiving a digital 3D representation of the patient's set of teeth from a scanning device 641, such as the TRIOS intra-oral color scanner manufactured by 3 shape A/S, or capable of receiving scan data from such a scanning device and forming a digital 3D representation of the patient's set of teeth based on such scan data.) with at least one algorithm that is configured to perform the method of claim 1. ([Par 31] “The tooth shade region can be defined by a structure encircling a portion of the tooth surface in the digital 3D representation, where either the operator or a computer implemented algorithm decides where each geometric structure is located on the digital 3D representation”)
Claim 16. Esbech makes obvious A computer program comprising instructions that cause a computer device comprising a sensor (203) for detecting a target data set based on a natural tooth, to perform the process steps according to claim 1. ([Par 198] “The features of the method described above and in the following may be implemented in software and carried out on a data processing system or other processing means caused by the execution of computer-executable instructions. The instructions may be program code means loaded in a memory, such as a RAM, from a storage medium or from another computer via a computer network.”)
Claim 17. Esbech makes obvious A computer program product comprising program code which is stored on a non-transitory machine-readable medium, the machine-readable medium comprising computer instructions executable by a processor, which computer instructions cause the processor to perform the method according to claim 1. ([Par 50] “In a further embodiment the system comprises a computer and software for performing the method steps of the invention.”)
Claim 18. Korten teaches wherein the sensor (203) comprises a digital camera, a 3D scanner, ([Par 5] “capturing the shape of a patient's teeth, for example by scanning a plaster model of the patient's teeth or alternatively by scanning the actual teeth in the patient's mouth;” [Par 59] “… may be scanned, for example using an optical digital scanner, for providing a computer model of the patient's dentition, and/or a computer model of a particular tooth structure, like the tooth stump of the tooth to be restored 11. Such a scanner is for example available under the designation Lava.TM. Scan ST or Lava.TM. C.O.S., from 3M ESPE AG, Germany. The skilled person will recognize several alternative ways for providing a computer model of a tooth structure. For example the tooth structure may be directly scanned in the patient's mouth for providing a tooth structure model, or the tooth structure may be scanned from the dental impression and inverted. Further the tooth structure may be designed using a dental CAD system.” [Par 48] “The system is adapted for visualizing a three-dimensional reference surface that is based on a shape of at least one of a tooth structure of a tooth to be restored in a patient's dentition, and a dental restoration for the tooth.”) a 3D camera system, a spectrometer, or a digitized color key.
Conclusion
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/M.P.M./Examiner, Art Unit 2187
/EMERSON C PUENTE/ Supervisory Patent Examiner, Art Unit 2187
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