Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
For the purpose of examination, the priority date for claims 1-20 is 05/09/2022.
Claim Objections
Claims 1, 9, 15 and 18 are objected to because of the following informalities:
Claim 1, lines 8 and 11, claim 9, lines 6 and 10, and claim 15, line 4, “the scanning area and apart from the patient” should be corrected to “the scanning area apart from the patient” for consistency with the previous limitation which states, “wherein the upper and lower denture in the patient bite orientation are positioned in the scanning area apart from the patient”.
Claim 18, line 5, “(i) in the scanning field” should be “(ii) in the scanning field” as this is the second alternative option in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is 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 20, lines 2-3 state, “…receiving a color image representing one or more of the upper denture and the lower denture…”. The scope of the claim is unclear as to whether one or both limitations are required due to the use of “and” between the alternative options. For the purpose of examination, the claim is interpreted as, “…receiving a color image representing one or more of the upper denture or the lower denture…”.
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 9-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 – Determination as to whether the claims are directed to a statutory category as specified in 35 U.S.C. 101 (MPEP 2106.03)
Claims 9-14 recite a method of generating a digital denture model comprising the steps of positioning the upper and lower denture together, performing a CT scan, automatically converting the CT scan into digital data models, automatically positioning the digital data models and returning the digital data models.
Claims 15-20 recite a method of preparing a digital denture model comprising the steps of receiving scan data, automatically generating a bite model, determining a position of the upper and lower denture models, and generating a digital denture model.
These methods fall into the category of a "process" (MPEP 2106.03).
Step 2A Prong 1 – Determination as to whether the claims recite a Judicial Exception including an abstract idea, law of nature, or natural phenomenon (MPEP 2106.04)
Regarding claim 9, the step of performing an automated quality analysis is directed to an abstract idea, a mental process capable of being performed in the human mind, including observations, evaluations and judgements. The previous steps of positioning and receiving the denture scans are considered data collection steps. Quality analysis is a process capable of being performed by simply observing the image and noting areas of poor image quality, such as low resolution.
Regarding claim 10, the step of generating a model by orientating the lower and upper denture scans according to a bite scan is another mental process capable of being performed in the human mind by mentally aligning the denture models, with the previous positioning steps acting as data collection steps for generating the model.
Regarding claims 11-12, detecting and removing the bite registration material from a digital model is a visual observation performed by mentally evaluating the image for darker or lighter regions.
Regarding claim 13, adjusting the field of view based on the quality analysis is another mental process, capable of being performed by visually evaluating the image quality and adjusting the scan based on this assessment.
Regarding claim 14, categorizing the scan image and being prompted to place a positioning sticker is a mental process performed by visually observing the denture and making a judgement on where to place the sticker.
Regarding claim 15, the steps of automatically generating a bite model, upper denture model and lower denture model, determining a position of the denture models and subsequently generating a denture model based on the relative position are all mental processes capable of being performed in the human mind. The previous steps of receiving scan data are considered data preparation steps for generating the model. In analyzing and forming a model, the dentures are capable of being mentally evaluated to determine how to fit the upper and lower components in a proper occlusal position.
Regarding claim 16, the step of converting the digital files is considered an abstract idea as there are not specific details in the claim suggesting a practical application of the file conversion.
Regarding claim 17, the step of selecting a surface of the bite model, upper or lower denture model is another mental process capable of being performed in the human mind in choosing an appropriate denture model for further analysis.
Regarding claim 18, detecting a position of a radio-opaque sticker is another mental process performed by visually observing the scan of the patient data, with the step of orientating the bite scan per the stickers also being a judgement that is made by observing the positioning of the stickers.
Regarding claim 19, removing irregularities within the denture model is another mental process performed by observing areas of poor image quality and removing these areas.
Regarding claim 20, correlating the extracted color and pattern information from the color images to the scanned images is another form of evaluating the data from the denture scans.
Using a computer as a tool to perform these listed concepts is still a recitation of a mental process (MPEP 2106.04(C)). Amounting to more than an abstract idea requires more than a mere tie to a technological or scanning environment, the abstract idea must be rooted in computer technology and solving a problem arising from computer technology. In this instance, the method steps are a series of abstract ideas linked to a CT scanner and subsequent automation of the method, which does not amount to more than the abstract idea.
Step 2A, Prong Two – Determination as to whether the claims as a whole integrate the judicial exception into a practical application
This judicial exception is not integrated into a practical application because:
Regarding claims 9-20, the claimed invention does not recite additional elements that integrate the judicial exception into practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use (MPEP 2106.04(d)). The additional step of using prompts from a user interface to tell a user how to prepare the scan are mere instruction to apply the judicial exceptions of these claims to a computer. The computer implementation of this method is insignificant extra solution activity and does not amount to an inventive concept, particularly when the activity is well-understood and conventional. For at least these reasons and as claims 9-20 do not recite additional elements which integrate the judicial exception into a practical application, the abstract mental processes identified for claims 9-15, and 17-20 are not integrated into a practical application.
Step 2B – Determination as to whether the claims amount to significantly more than the judicial exception (MPEP 2106.05)
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
Regarding claims 9-20, as set forth above with respect to Step 2A Prong One, the claimed method steps are all capable of being performed mentally and represent nothing more than concepts related to performing observations, evaluations, and judgements, which fall within the judicial exception. The claimed steps of positioning the upper and lower denture together, performing a CT scan, receiving the scan, performing an automated quality analysis and generating a denture model require nothing more than a generic computer processor, display and CT machine. The disclosure does not describe additional features to suggest these devices are beyond a generic component for the apparatus. Additionally, the design method is not disclosed as improving the manner in which the CT machine operates. Mere recitation of generic conventional processing used in a conventional manner to perform conventional computer functions that are well understood and routine does not amount to “significantly more” than the judicial exception. The claims do not go beyond inputting data (“receiving”) and processing data ( “generating” and "analyzing") with a standard computer.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Additional elements of claims 10-14 and 16-20 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. The claims set forth do not require that the method be implemented by a particular machine and they do not require that the method particularly transforms a particular article. When viewed as a combination, the identified additional elements set forth a process of analyzing information of specific content and are not directed to any particularly asserted inventive technology for performing these functions. The disclosure and claims do not require anything beyond a generic computer to obtain and analyze the data according to mathematical algorithms. Therefore, the claimed method and apparatus fall within the judicial exception to patent eligible subject matter of an abstract idea without significantly more.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4, 5, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherer (US 20150064644 A1) in view of Llop et al (US 20150327958 A1), herein referred to as Llop.
Regarding claim 1, Scherer discloses a method (Fig. 9) of using a CT scanning device to obtain scanned denture data (refer to Paragraphs [0036], [0046]; the invention is drawn to scanning a dental prosthesis with CBCT), the method comprising:
positioning an upper denture and lower denture together in a of a patient (refer to Paragraph [0044], Figs. 11-12; the upper and lower denture (22) are arranged in occlusion);
positioning the upper and lower denture in the patient bite orientation in a scanning area of the CT scanning device (refer to Paragraph [0046], Figs. 11-12; the denture (22) is placed in the patient’s mouth in occlusion, and the patient is shown positioned in the CBCT scanning area);
performing, with the CT scanning device, a single CT scan of the upper and lower denture in the patient bite orientation in the scanning area
automatically converting the single CT scan of the upper and lower denture in the patient bite orientation in the scanning area into digital data models representing a patient bite scan, an upper denture surface, and a lower denture surface (refer to Paragraph [0046], Fig. 11; the scanning device creates digital data files of the bite scan, where the bite scan includes the upper denture and lower denture); and
Scherer does not disclose wherein the upper and lower denture in the patient bite orientation are positioned in the scanning area apart from the patient, automatically positioning the digital data models representing the upper denture surface and the lower denture surface relative to each other based on the digital data model representing the patient bite scan and returning the positioned digital data models.
Llop discloses a method for extraoral bite scans of castings of the patient’s teeth in the same field of endeavor (refer to Paragraphs [0049], [0050]), further disclosing the method as applicable to fully edentulous patients (refer to Paragraph [0043]). The method further comprises positioning the upper and lower dental castings (analogous to an upper and lower dentures) in the scanning area apart from the patient (refer to Paragraph [0051]; a scanned data set of the two castings orientated in full occlusion are scanned to form a data set), automatically positioning the digital data models representing the upper surface and the lower surface relative to each other based on the digital data model representing the patient bite scan (refer to Paragraph [0056]; the maxillary and mandibular arch teeth anatomies of the extraoral scan are aligned in step 108 by imaging software to form the inter-arch relationship modeled by the bite registration) and returning the positioned digital data models(refer to Paragraph [0056], Fig. 2; the aligned data from step 108 is output or returned to the next process step (110)). Scanning the bite model separate from the patient allows the system to create a complete anatomical representation along with intraoral scans, as the extraoral scans include clearly defined teeth and tissue contours (refer to Paragraph [0058]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of denture scanning as taught by Scherer (refer to Fig. 9), with the method of extraoral scanning and alignment as taught by Llop (refer to Paragraphs [0051], [0056], Fig. 2) in order to create a clear, complete anatomical representation (refer to Paragraph [0058]).
Regarding claim 2, Scherer and Llop disclose the method of claim 1; Scherer further discloses the method comprising:
positioning the upper denture in the scanning area of the CT scanning device (refer to Paragraph [0048], Fig. 13; the dental prothesis device (22) is positioned on non-radiopaque material (12) in the scanning area of the CBCT scanner (16));
obtaining, using the CT scanning device, an upper denture scan (refer to Paragraph [0048], Fig. 13; the dental prosthesis is scanned (22))
positioning the lower denture in the scanning area of the CT scanning device (refer to Paragraphs [0048], [0051], Fig. 13; the process disclosed for the first prosthesis is repeated for the other dental prosthesis, which in the case of a dual denture would be the lower component; the dental prothesis device (22) is positioned on non-radiopaque material (12) in the scanning area of the CBCT scanner (16)); and
obtaining, using the CT scanning device, a lower denture model scan (refer to Paragraph [0048] and Fig. 13; the dental prosthesis is scanned (22)).
Regarding claim 4, Scherer and Llop disclose the method of claim 1; Scherer further discloses
the process of removing the upper denture, lower denture and bite spacing material from the patient’s mouth (refer to Paragraph [0048]; the dental prosthesis, impression material and spacing material are removed from the patient’s mouth).
Scherer is silent to preparing bite registration material, positioning the bite registration material, instead opting for the use of cotton to capture the dentures in occlusion (refer to Paragraph [0044], Fig. 12).
Llop further discloses:
positioning a bite registration material between the upper denture and the lower denture prior to positioning the upper denture and the lower denture together in the patient bite orientation (refer to Paragraph [0059], Fig. 4B; the patient (38) bites down on an elastomer material (22) to make an impression of the upper and lower jaws in occlusion); and
preparing the bite registration material (22) by:
positioning a bite registration material between the upper denture and the lower denture while the upper denture and the lower denture are in the [[a]] patient’s mouth (refer to Paragraph [0059], Fig. 4B; the elastomer material (22) is placed in the patient’s mouth (14));
preparing a bite impression in the bite registration material while the upper denture and the lower denture are in the [[a]] patient’s mouth (refer to Paragraph [0059]; the elastomer material (12) captures the jaws in occlusion); and
after preparing the bite impression, removing the bite registration material from the patient’s mouth (refer to Paragraph [0047], Fig. 4B; the elastomer material (22) is set and removed from the patient’s mouth),
wherein positioning the upper dental cast (26) and the lower dental cast (26) together in the patient bite orientation further comprises using the bite impression to align the upper dental cast (26) and the lower cast (26) in the patient bite orientation (refer to Paragraphs [0051], [0060], Fig. 4B; the dental castings have the elastomer material (22) placed between the upper and lower castings (26) to hold them in a full occlusion position; the dental castings (26) are analogous to the upper and lower dentures).
The method of using bite registration material is advantageous for providing a means of constantly and accurately capturing the relationship between the maxillary and mandibular occlusion (refer to Paragraph [0018]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of positioning the occlusal denture orientation with spacing material as taught by Scherer (refer to Paragraph [0044], Fig. 12) with the method of using bite registration material as taught by Llop (refer to Paragraphs [0051], [0059]-[0060]) in order to constantly and accurately capture the relationship between the maxillary and mandibular occlusion (refer to Paragraph [0018]).
Regarding claim 5, Scherer and Llop disclose the method of claim 4; Scherer is silent to wherein the bite registration material is at least one of (i) a radio-opaque material or [[and]] (ii) a radio-translucent material.
Llop further discloses wherein the bite registration material is a radio-opaque material (refer to Paragraph [0056]; the silicone elastomer material is radio-opaque). Radio-opaque materials allow for scan visibility (refer to Paragraph [0044]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of positioning the occlusal denture orientation with spacing material as taught by Scherer (refer to Paragraph [0044], Fig. 12) with the method of using radio-opaque bite registration material as taught by Llop (refer to Paragraphs [0051], [0056] [0059]-[0060]) in order to capture the relationship between the maxillary and mandibular occlusion with the radio-opaque material (refer to Paragraphs [0018], [0044]).
Regarding claim 6, Scherer and Llop disclose the method of claim 4; Scherer is silent to wherein the bite registration material has a known density different than a density of a material forming the upper denture and the lower denture.
Llop discloses wherein the bite registration material has a known density different than a density of a material forming the upper denture and the lower denture, allowing the bite registration to be isolated from the scanned dental structures for modeling inter-arch relationships (refer to Paragraph [0056]; the bite registration material has a different scanned density from scanned teeth and gums)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of positioning the occlusal denture orientation with spacing material as taught by Scherer (refer to Paragraph [0044], Fig. 12) with the method of using radio-opaque bite registration material of a different density as taught by Llop (refer to Paragraphs [0051], [0056] [0059]-[0060]) in order to isolate the bite registration material for modeling inter-arch relationships (refer to Paragraph [0056]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherer (US 20150064644 A1) and Llop et al (US 20150327958 A1), herein referred to as Llop as applied to claim 1 above, and further in view of Bell et al. (US 20210244515 A1), herein referred to as Bell.
Regarding claim 3, Scherer and Llop disclose the method of claim 1; Scherer discloses positioning the upper denture and the lower denture together in the [[a]] patient bite orientation in the scanning area of the CT scanning device (refer to Paragraph [0046], Fig. 11); both Scherer and Llop are silent to the method comprising aligning a midline of the upper denture and the lower denture with a fiducial in the scanning area.
Bell discloses a method of using a CT scanning device to obtain scanned denture data (refer to Paragraphs [0059]-[0061]; CBCT or CT scanning is performed on dental appliances, which includes full dentures), with the method including positioning the upper denture and the lower denture together in a patient bite orientation in the scanning area of the CT scanning device by aligning a midline of the upper denture and the lower denture with a fiducial in the scanning area (refer to Paragraphs [0037], [0045]- [0046], [0058], Fig. 6; a fiducial marker (28c) is installed below the midline of the anterior nasal spine, with another fiducial marker (28f) installed on the medial border of mandible prior to scanning (100) the occluded jaw).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherer (US 20150064644 A1) and Llop et al (US 20150327958 A1), herein referred to as Llop, as applied to claim 1 above, and further in view of Lu et al. (US 20160256123 A1), herein referred to as Lu.
Regarding claim 7, Scherer and Llop disclose the method of claim 1, but do not disclose a color camera being coupled to the CT scanning device such that, a color image can be simultaneously obtained with performing the single CT scan of the upper and lower denture in the patient bite orientation.
Lu discloses an imaging apparatus (10) in the same field of endeavor (refer to Paragraph [0016], Fig. 1). The imaging apparatus a color camera that is coupled to the CT scanning device (refer to Paragraphs [0052], [0060], Figs. 1, 4C; the generator apparatus (24) of the imaging apparatus (10) contains a color camera (36)), wherein obtaining the color image is performed simultaneously with performing the CT scan of the dentition (refer to Paragraph [0067], Fig. 7; in Step S120, CBCT scan data and color image data is acquired). The use of both 3D radiographic imaging and color imaging provides an accurate rendering of the dentition for the practitioner (refer to Paragraphs [0004]-[0005]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of using a CT scanning device as taught by Scherer and Llop (refer to Paragraph [0046] of Scherer) with using a color camera simultaneously as taught by Lu (refer to Paragraph [0067], Fig. 7)in order to provide an accurate rending of the dentition (refer to Paragraphs [0004]-[0005]).
Claim(s) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherer (US 20150064644 A1) in view of Llop et al (US 20150327958 A1), herein referred to as Llop as applied to claim 1 above, and further in view of Carrier et al. (US 20180125610 A1), herein referred to as Carrier.
Regarding claim 8, Scherer and Llop disclose the method of claim 1; neither disclose adjusting a field of view of the CT scanning device to include all features of the upper denture and the lower denture together in the patient bite orientation prior to obtaining the bite scan; and
re-adjusting the field of view of the CT scanning device after performing the bite scan in response to a notification that the field of view of the first scan does not include all features of the upper denture and the lower denture together in the patient bite orientation.
Carrier discloses a method of guiding a user through acquiring images in the same field of endeavor (refer to Paragraph [0095]). The method requires the user to manually adjust the camera view to capture the required view of the patient’s teeth, and further, requires the user to re-adjust, taking an alternative image when all features of the dentition are not included in response to a warning message (refer to Paragraphs [0126], [0128]). This is the same method of re-adjustment as disclosed by Applicant (see Paragraph [0066] of specification).
As Carrier teaches adjusting and re-adjusting a field of view to capture the required dentition (refer to Paragraphs [0126], [0128]), and Scherer (refer to Paragraph [0050]) and Llop (refer to Fig. 4B) teach CT scanning of the upper and lower dentures together in a patient bite orientation, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the steps of adjusting and re-adjusting the field of view to include all features of interest as taught by Carrier in the combined method as taught by Scherer and Llop in order to obtain an accurate virtual representation of all features.
Regarding claim 9, Scherer discloses a method (Fig. 9) of generating a digital denture model (refer to Paragraphs [0003], [0050]; the invention is drawn to scanning a dental prosthesis with CBCT to create a virtual model), the method comprising:
positioning an upper denture and a lower denture together in a of a patient in a scanning area of the CT scanning device orientation (refer to Paragraphs [0044]-[0046], Figs. 11-12; the upper and lower denture are arranged in occlusion in view of the CBCT scanner);
performing, using the CT scanning device, a single CT scan of the upper denture and the lower denture together in the patient bite orientation in the scanning area
receiving [[a]] digital bite scan data based on the single CT scan of the upper denture and the lower denture together in the patient bite orientation in the scanning area (refer to Paragraph [0046], Fig. 11; the scanning device creates digital data files of the bite scan, where the bite scan includes the upper denture and lower denture).
Scherer does not disclose wherein the upper and lower denture in the patient bite orientation are positioned in the scanning area apart from the patient.
Llop discloses a method for extraoral bite scans of castings of the patient’s teeth in the same field of endeavor (refer to Paragraphs [0049], [0050]), further disclosing the method as applicable to fully edentulous patients (refer to Paragraph [0043]). The method further comprises positioning the upper and lower dental castings (analogous to an upper and lower dentures) in the scanning area apart from the patient (refer to Paragraph [0051]; a scanned data set of the two castings orientated in full occlusion are scanned to form a data set). Scanning the bite model separate from the patient allows the system to create a complete anatomical representation along with intraoral scans, as the extraoral scans include clearly defined teeth and tissue contours (refer to Paragraph [0058]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of denture scanning as taught by Scherer (refer to Fig. 9), with the method of extraoral scanning as taught by Llop (refer to Paragraphs [0051], [0056], Fig. 2) in order to create a clear, complete anatomical representation (refer to Paragraph [0058]).
Scherer also does not disclose this method including providing prompts on a user interface, performing [[a]] an automated quality analysis of the digital bite scan data , and returning results automated quality analysis on a graphical user interface (GUI) display.
Carrier discloses a method of guiding a user in taking a predetermined set of images in the same field of endeavor (refer to Paragraph [0007]). The method incorporates the use of a processor to execute instructions for checking the image quality of a captured image and displaying on the screen or GUI if the image quality is below a threshold (refer to Paragraph [0024], [0126], Fig. 6A). This process is analogous to the process of Applicant’s device (see Paragraph [0032] of specification), in which the quality analysis is provided by a computer, as all computers by definition include a central processing unit for executing instructions and performing functions. This quality image check is beneficial to ensure the captured image is of high quality (refer to Paragraph [0095]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of using a CT scanning device as taught by Scherer and Llop with the use of image quality analysis as taught by Carrier, in order to ensure the high quality of the captured images (refer to Paragraph [0095]).
Carrier further discloses the use of a processor to display instructions or prompts on positioning the patient’s teeth in a series of predetermined views or positions (refer to Paragraphs [0028]-[0029]), wherein the eight predetermined views include views of the upper and lower arch with the jaw closed (refer to Paragraph [0122] and Fig. 5A). This process is analogous to the process of Applicant’s device (see Paragraph [0032] of specification), in which the prompts are provided by a computer, as all computers by definition include a central processing unit for executing instructions and performing functions. This method is beneficial as the automated guidance ensures high quality images are captured (refer to Paragraph [0095]).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of using a CT scanning device as taught by Scherer and Llop with the use of visually guided prompts as taught by Carrier in order to automate the process of capturing the denture scans, thereby reducing error between operators ensuring high quality images are captured (refer to Paragraph [0095]).
Regarding claim 10, Scherer, Llop and Carrier disclose the method of claim 9; Scherer discloses:
positioning an upper denture alone in the scanning area of the CT scanning device (refer to Paragraph [0048], Fig. 13; the dental prothesis device (22) is positioned on non-radiopaque material (12) in the scanning area of the CBCT scanner (16))
performing a CT scan of the upper denture (refer to Paragraph [0048], Fig. 13; the dental prosthesis is scanned (22));
positioning a lower denture alone in the scanning area of the CT scanning device (refer to Paragraph [0048], [0051], Fig. 13; the process disclosed for the first prosthesis scanned alone as shown in Fig. 13 is repeated for the other dental prosthesis, which in the case of a dual denture would be the lower component; the dental prothesis device (22) is positioned on non-radiopaque material (12) in the scanning area of the CBCT scanner (16))
generating a model of a denture surface based on the bite scan, the upper denture scan, and the lower denture scan, wherein generating the model comprises (refer to Paragraph [0050]; a virtual model (15) is created using the direct and indirect scans of the mouth portion, which equate to the scan of the dentures in occlusion and the separate scans of the upper and lower denture):
orienting the upper jaw model scan relative to the lower jaw model scan based on the bite scan (refer to Paragraph [0048], [0050]; the first scan of the dental prosthesis (22) in occlusion in the patient’s mouth is aligned with the images of the second scans of the dental prosthesis (22) after removing the prosthesis (22) from the patient’s mouth); and
preparing the model of the dental surface based on the oriented upper jaw model and lower jaw model, where the upper jaw model and the lower jaw model are oriented according to an orientation in the bite scan (refer to Paragraphs [0048], [0050]; the virtual model (15) is prepared by digital alignment of the combination of the individual second denture scans with the first occlusal scan).
Scherer also does not disclose this method including providing prompts on a user interface.
As stated in the rejection for claim 9 above, Carrier further discloses the use of a processor to display instructions or prompts on positioning the patient’s teeth in a series of predetermined views or positions (refer to Paragraphs [0028]-[0029]), wherein the eight predetermined views include views of the upper and lower arch with the jaw closed (refer to Paragraph [0122] and Fig. 5A), which is beneficial as the automated guidance ensures high quality images are captured (refer to Paragraph [0095]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of using a CT scanning device as taught by Scherer and Llop with the use of visually guided prompts as taught by Carrier in order to automate the process of capturing the denture scans, thereby reducing error between operators ensuring high quality images are captured (refer to Paragraph [0095]).
Regarding claim 11, Scherer, Llop and Carrier disclose the method of claim 9; Scherer and Carrier are silent to detecting, in the bite scan, a presence of a bite registration material positioned between the upper denture and the lower denture based on detecting a material having a different density than a density of one or more materials of the upper denture and the lower denture, instead opting for the use of cotton to capture the dentures in occlusion (refer to Paragraph [0044] and Fig. 12).
Llop further discloses detecting, in the bite scan, a presence of a bite registration material positioned between the upper denture and the lower denture based on detecting a material having a different density than a density of one or more materials of the upper denture and the lower denture (refer to Paragraph [0056]; the bite registration material has a different scanned density than the scanned teeth, gums and hard tissue allowing the material to be differentiated by image segmentation). The method of using bite registration material allows the scanning modality to “see” and record the formed bite registration to form a patient specific model (refer to Paragraph [0017]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of generating a denture as taught by Scherer and Carrier with the method of detecting bite registration material as taught by Llop in order to form a patient specific model (refer to Paragraph [0017]).
Regarding claim 12, Scherer, Llop and Carrier disclose the method of claim 11; Scherer and Carrier are silent to adjusting a threshold of the model of the denture surface to remove the bite registration material.
Llop further discloses adjusting a threshold of the model of the denture surface to remove the bite registration material (refer to Paragraph [0056]; in the context of CT scans, threshold refers to differentiating between different structures based on a defined density; the bite registration material is isolated from the combined upper and lower dentition bite structure for further manipulation by image segmentation via density differentiation). This method step allows the imaging software to individually coordinate the scanned teeth (refer to Paragraph [0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of generating a denture as taught by Scherer and Carrier with the method of adjusting the threshold to remove the bite registration material as taught by Llop in order to allow the imaging software to individually coordinate the scanned teeth (refer to Paragraph [0056]).
Regarding claim 13, Scherer, Llop and Carrier disclose the method
presenting, on the user interface, at least one of (i) an image of the bite scan (refer to Paragraph [0050], Fig. 14; data files from the direct scan are viewable in the computer system (18)); Scherer is silent to an indication of scan quality with the image of the bite scan, and generating a prompt to adjust a field of view of the CT scanning device based on a quality analysis of the bite scan, where a result of the quality analysis indicates that not all features of the bite scan are included in a current field of view, wherein the result comprises the indication of scan quality.
Carrier further discloses presenting, on the user interface an indication of scan quality with the image of the bite scan (refer to Paragraphs [0024], [0126], Fig. 6A; a processor executes instructions for checking the image quality of a captured image and displaying a message on the screen if the image quality is below a threshold), generating a prompt to adjust a field of view based on a quality analysis of a bite image where a result of the quality analysis indicates that not all features of the bite image are included in a current field of view, wherein the result comprises the indication of the scan quality (refer to Paragraphs [0126], [0128]; image analysis via image recognition algorithms requires the user to take an alternative image when all features of the dentition are not included, in response to a warning message). This quality image check is beneficial to ensure the captured image is of high quality (refer to Paragraph [0095]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of generating a denture model via CT scanning as taught by Scherer and Llop with the method of adjusting a field of view in response to quality image analysis as taught by Carrier in order to ensure to ensure the captured image is of high quality (refer to Paragraph [0095]).
Regarding claim 14, Scherer, Llop and Carrier disclose the method of claim 9; Scherer further discloses:
positioning the upper or [[and]] the lower denture in the scanning area of the CT scanning device (refer to Paragraph [0048], Fig. 13; the second scan process includes positioning the dental prothesis (22) after removing the device from the patient’s mouth, where the dental prosthesis can be an upper or lower denture device);
placing a positioning sticker on one or more of the upper denture or the lower denture prior to scanning (refer to Paragraph [0006]; a current known method of imputing dental prothesis devices into a scanned data file includes attaching radiographic markers to the dental prosthesis (22) before subsequently scanning);
Neither Scherer or Llop disclose presenting, on the user interface, a suggested identification of a scan as one of the bite scan, the upper denture scan, or [[and]] the lower denture scan, wherein the suggested identification is based on an analysis of the scan resulting in a categorization of the scan and prompting a user, on the user interface, to position one or more of the upper denture or [[and]] the lower denture relative to an indicator in the scanning area of the CT scanning device.
Carrier further discloses presenting, on the user interface, a suggested identification of a scan as one of the bite scan, the upper denture scan, or [[and]] the lower denture scan, wherein the suggested identification is based on an analysis of the scan resulting in a categorization of the scan (refer to Paragraph [0132]; the overlay method of the image quality analysis includes automatic identification of teeth to determine which predetermined view to use, wherein the predetermined views include closed anterior, closed buccal, and occlusal maxillary and mandibular jaw views);
prompting a user, on the user interface, to position one or more of the upper jaw or [[and]] the lower jaw relative to an indicator in the image scanning area of (refer to Paragraphs [0132] – [0133], Figs. 2A-2C ; the overlay method of the image quality analysis includes a color indicator which prompts the user via green and red colors to position the teeth according to the overlay capturing both upper and lower jaw images; the upper and lower jaws are analogous to the upper and lower dental structures). The overlays guide the user for ease of capturing the desired image (refer to Paragraph [0007]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of generating a digital dental model as taught by Scherer and Llop with suggested identification prompts and positioning prompts on the user interface as taught by Carrier in order to guide the user for ease of capturing the desired image (refer to Paragraph [0007]).
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherer (US 20150327958 A1) in view Llop et al (US 20150327958 A1), herein referred to as Llop, and further in view of Bell et al. (US 20210244515 A1), herein referred to as Bell.
Regarding claim 15, Scherer discloses a method (Fig. 9) of preparing a digital denture model (refer to Paragraphs [0003], [0050]; the invention is drawn to scanning a dental prosthesis with CBCT to create a virtual model), the method comprising:
receiving digital CT scan data from a single scan of an upper and lower denture in a bite orientation of a patient in a scanning area (refer to Paragraph [0046], Figs. 11-12; the scanning device creates data files from the scan of the denture (22) in the patient’s mouth in occlusion ), wherein the digital CT scan data comprises
[[a]] digital bite scan data corresponding to the upper denture positioned with the [[a]] lower denture in the [[a]] patient bite orientation (refer to Paragraph [0046], Figs. 11-12; the scanning device creates data files from the scan of the denture (22) in the patient’s mouth in occlusion),
[[an]] digital upper denture scan data (refer to Paragraph [0048], Figs. 13-14; the scanning device creates data files from the scan of the dental prothesis device (22) positioned on non-radiopaque material (12) in the scanning area of the CBCT scanner (16)), and
[[a]] digital lower denture scan data (refer to Paragraphs [0048], [0051], Figs. 13-14; the process disclosed for the first prosthesis (creating data files from the scan of the dental prothesis device (22) positioned on non-radiopaque material (12)) is repeated for the other dental prosthesis, which in the case of a dual denture would be the lower component);
automatically generating digital bite model, [[an]] a digital upper denture model, and a digital lower denture model from the received digital bite scan data, digital upper scan data, and digital lower scan data (refer to Paragraph [0050], Fig. 14; the imaging software processes the data files from the CT scanning device (16) to create 3D models (15) of the individual and combined bite scan),
determining a relative position of the digital upper denture model and the digital lower denture model based on processing the digital bite scan data (refer to Paragraph [0048], [0050]; the first scan of the dental prosthesis (22) in occlusion in the patient’s mouth is aligned with the images of the second scans of the upper and lower dental prostheses after removing the prostheses from the patient’s mouth);
generating a digital denture model based on the digital upper denture model, digital lower denture model, and determined relative positioning (refer to Paragraphs [0048], [0050], Figs. 13-14; the final virtual model (15) is prepared by digital alignment of the combination of the individual second denture scans with the first occlusal scan); and
returning the digital denture model (refer to Paragraph [0050], Fig. 14; the final virtual model (15) is output or returned).
Scherer is silent to wherein the upper and lower denture in the patient bite orientation are positioned in the scanning area apart from the patient.
Llop discloses a method for extraoral bite scans of castings of the patient’s teeth in the same field of endeavor (refer to Paragraphs [0049], [0050]), further disclosing the method as applicable to fully edentulous patients (refer to Paragraph [0043]). The method further comprises positioning the upper and lower dental castings (analogous to an upper and lower dentures) in the scanning area apart from the patient (refer to Paragraph [0051]; a scanned data set of the two castings orientated in full occlusion are scanned to form a data set). Scanning the bite model separate from the patient allows the system to create a complete anatomical representation along with intraoral scans, as the extraoral scans include clearly defined teeth and tissue contours (refer to Paragraph [0058]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of denture scanning as taught by Scherer (refer to Fig. 9), with the method of extraoral scanning as taught by Llop (refer to Paragraphs [0051], [0056], Fig. 2) in order to create a clear, complete anatomical representation (refer to Paragraph [0058]).
Scherer is also silent to automatically generating digital bite model, the digital upper denture model, and the digital lower denture model comprises converting the digital bite scan data, the digital upper denture scan data, and the digital lower denture scan data to digital mesh representations of denture surfaces.
Bell discloses a method for scanning and analyzing jaws in the same field of endeavor (refer to Abstract and Paragraphs [0059]-[0060]; the scanning of dental appliances includes full dentures). The method as disclosed by Bell comprises scanning the jaw model in occlusion with a CBCT scanner (refer to Paragraph [0059]), before converting the file format from DICOM to STL (refer to Paragraph [0062]; first scan result (98), is converted to STL from DICOM). The file conversion is performed, as this file format is more manageable for further virtual modeling (refer to Paragraph [0062]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of preparing a dental model as taught by Scherer and Llop with file conversion as taught by Bell in order to generate a more manageable file format.
Regarding claim 16, Scherer, Llop and Bell disclose the method of claim 15; Scherer further discloses wherein the bite scan, the upper denture scan, and the lower denture scan are received as DICOM files (refer to Paragraph [0050]; the virtual modeling of the first scans and seconds scans of the dentures, which includes the occlusion model and individual upper and lower denture scans is in DICOM), but is silent to the method further comprising converting the DICOM files to one of an STL file, PLY file, OBJ file, AMF file, and 3MF file prior to determining the relative position of the upper denture scan and lower denture scan based on the bite scan.
Bell further discloses converting the DICOM files to one of an STL file, PLY file, OBJ file, AMF file, and 3MF file prior to determining the relative position of the upper denture scan and lower denture scan based on the bite scan (refer to Paragraphs [0062], [0074]; prior to aligning the digital jaw models (112, 119, 158, 160), the first scan result (98) is converted to a more manageable file format (STL) from DICOM). The file conversion is performed, as STL file format is more manageable for further virtual modeling (refer to Paragraph [0062]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of preparing a dental model as taught by Scherer and Llop with file conversion as taught by Bell in order to generate a more manageable file format.
Regarding claim 17, Scherer, Llop and Bell disclose the method of claim 15, Scherer and Bell are silent to adjusting a threshold to select a surface of the bite model, the upper denture model, and the lower denture model.
Llop further discloses adjusting a threshold of the model of the denture surface to select a surface of the dental model (refer to Paragraph [0056]; in the context of CT scans, threshold refers to differentiating between different structures based on a defined density; the bite registration material is isolated from the combined upper and lower dentition bite structure, analogous to the denture models). This method step allows the imaging software to individually coordinate the scanned teeth (refer to Paragraph [0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of preparing a denture model as taught by Scherer and Bell with the method of adjusting the threshold to select a surface of the dental model as taught by Llop (refer to Paragraph [0056]), in order to allow the imaging software to individually coordinate the scanned teeth (refer to Paragraph [0056]).
Regarding claim 18, Scherer, Llop and Bell disclose the method of claim 15;
Scherer further discloses placing a positioning sticker on one or more of the upper denture or the lower denture prior to scanning (refer to Paragraph [0006] of Scherer; a current known method of imputing dental prosthesis devices into a scanned data file includes attaching radiographic markers before subsequently scanning); however, Scherer and Llop do not further disclose detecting a position of the bite scan, the upper denture scan, and the lower denture scan within a scanning field based on detecting a presence and position of an indicator in scan data, wherein the indicator is a radio-opaque marker (i) positioned on one or more of the upper denture or [[and]] the lower denture and orienting the bite scan, the upper denture scan, and the lower denture scan based on the detected position.
Bell further discloses detecting a position of the bite scan, the upper denture scan, and the lower denture scan within a scanning field based on detecting a presence and position of an indicator in scan data, wherein the indicator is a radio-opaque marker (i) positioned on one or more of the upper denture or [[and]] the lower denture (refer to Paragraphs [0037], [0039]; radiopaque fiducial markers (28) are installed on one or more of the jaw members (12)) or (i) in the scanning field (refer to Paragraphs [0037], [0058]; the fiducial markers (28) are scanned, thereby being placed in the scanning field); and
orienting the bite scan, the upper denture scan, and the lower denture scan based on the detected position (refer to Paragraphs [0063], [0073]; constellation points are represented by the scanned fiducial markers (28), with these constellation of points being used as reference points to shift the individual jaw images in matching the first scan constellation points of the jaws in occlusion). Bell’s method generates a precise digital jaw model (116) that can be manipulated and analyzed to aid in therapeutic treatments (refer to Paragraph [0073]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of preparing the denture model as taught by Scherer and Llop with the method of detection alignment as taught by Bell in order to generate a precise digital jaw model for further analysis.
Regarding claim 19, Scherer, Llop and Bell disclose the method of claim 15; Scherer and Bell are silent to removing irregularities from one or more of the bite model, the upper denture model, and the lower denture model, wherein the irregularities are at least one of (i) voids within the bite model, the upper denture model, or [[and]] the lower denture model, (ii) voids on a surface of the bite model, the upper denture model, and the lower denture model, and (iii) metallic deposits in the bite model, the upper denture model, and the lower denture model, wherein the metallic deposits are indicated by a different density material.
Llop further discloses removing irregularities from one or more of the bite model, the upper denture model, and the lower denture model, wherein the irregularities are metallic deposits in the bite model, the upper denture model, and the lower denture model, wherein the metallic deposits are indicated by a different density material (refer to Paragraphs [0007], [0013], [0058]; scan distortions and scattered data can be discounted or eliminated from the digital representation; the distortions are due to metal in the patient’s mouth; by definition metal is a different density than the surrounding teeth and its material properties lead to the ricochet or scatter (indication) shown in the scanned image).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherer (US 20150327958 A1), Llop et al (US 20150327958 A1), herein referred to as Llop, and Bell et al. (US 20210244515 A1), herein referred to as Bell, as applied to claim 1 above, and further in view of Lu et al. (US 20160256123 A1), herein referred to as Lu.
Regarding claim 20, Scherer, Llop and Bell disclose the method of claim 15, but do not disclose receiving a color image representing one or more of the upper denture and the lower denture; extracting color and pattern information from the color image; and correlating the extracted color and pattern information on the upper denture model and the lower denture model.
Lu discloses a method of combining volume images with contour images in the same field of endeavor (refer to Paragraph [0016]). The method of using the system (10) includes receiving a color image representing the dentition (refer to Paragraph [0067]; Step S120 captures color images), extracting color and pattern information from the color image (refer o Paragraph [0056]; the reflectance images provide texture and color content for mapping), and correlating the extracted color and pattern information to the dentition (refer to Paragraph [0068]; reflectance image content from color imaging step S120 is mapped to the volume image content from Step S140, where the volume content is obtained from CBCT acquisition step S108). Combining the CBCT volume image data with color images aids in visualization of the patient’s appearance (refer to Paragraph [0016]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of preparing a digital denture model as taught by Scherer, Llop and Bell with the color image processing method as taught by Lu in order to easily visualize the patient’s appearance (refer to Paragraph [0016]).
Response to Arguments
The outstanding specification objection of Paragraph [0066] is withdrawn in view of the newly submitted specification amendment.
The outstanding claim 13 objection is withdrawn in view of the newly submitted claim amendments.
The outstanding 35 USC 112(b) rejections of claims 5, 13, 14, 16, 18-19 are withdrawn in view of the newly submitted claim amendments.
Examiner notes the outstanding 35 USC 112(b) rejection of claim 20 remains, as Applicant has not provided an argument or correction to remedy the indefiniteness.
Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the claims amount to more than the abstract idea, as stated in the above 35 USC 101 rejection, overcoming the rejection requires more than a mere tie to an environment. The claims tie abstract ideas to a CT machine and associated display. This tie-in is conventional, as it is well known in the art to create a digital model with a scanning machine and display. This is in line with recent USPTO guidance. Generating a digital denture model and preparing a digital denture model merely ties a denture model to the computing environment. To overcome this rejection, it is not the “technological context” (stating that models are digital or a graphical user interface is used) that needs to be emphasized, it is the rooting of the claims in the computer technology and solving a specific problem arising from the computer technology.
Applicant’s arguments with respect to independent claim(s) 1, 9, and 15 have been considered but are moot because the new ground of rejection relies on the combination of Scherer, Llop (claim 1), Scherer, Llop and Carrier (claim 9) and Scherer, Llop, and Bell (claim 15) that was not relied on in the prior rejection for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adriena J Webb Lyttle whose telephone number is (571)270-7639. The examiner can normally be reached Mon - Fri 10:00-7:00 EST.
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/ADRIENA J WEBB LYTTLE/Examiner, Art Unit 3772
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772