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 .
Claim Rejections - 35 USC § 101
Claims 1, 3, 8-14, 16-21, 23, and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an Abstract Idea, a Mental Process, without significantly more.
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 therefore, subject to the conditions and requirements of this title.
Regarding Claim 1, the claim recites “An apparatus for providing an assessment related to an aspect of periodontal health of an individual.” It appears the claim is directed to an Abstract Idea, a Mental Process, as assessments of periodontal health appear to typically be performed by a dentist in the mind using pocket/probing depths or imaging methods as later discussed in the prior art rejections. Therefore, the claim as an apparatus passes Step One in determining eligibility, but the claim may be directed to a Judicial Exception, a Mental Process, per Prong One of Step 2A in MPEP 2106.04. Further, it appears the claim limitations do not integrate the Judicial Exception of a Mental Process into a practical application per Prong Two of Step 2A. An analysis of Prong Two for each limitation is found below,
“the apparatus comprising: at least one processor configured to read out and execute instructions stored in at least one memory to thereby cause the apparatus to function”, does not integrate into a practical application, as per MPEP 2106.04 III, paragraph 4: “Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind."
“as an MRI data receiving unit for receiving MRI data that was generated using an MRI scanning machine, the MRI data having been generated from a scan of an oral area of the individual, and the oral area including at least part of teeth, gum tissue, and a bone of the individual;” does not integrate into a practical application, as an MRI machine is typically capable of scanning the human body (particularly without any further claim limitations as to how this scan or any particular resolution is performed) and the human body includes an oral area. Therefore, there does not appear to be any improvement to the technology of MRI scanning recited.
“an MRI analysis unit for generating analyzed MRI data in which at least one of hard tissue, soft tissue, an anatomical abnormality, a transition area between two tissues, and a transition area between tissue and an anatomical abnormality is identified;” does not integrate into a practical application, as an MRI machine is typically capable of scanning the human body and its strength is specifically suited to soft tissue imaging compared to other dentistry imaging techniques such as an X-ray. Therefore, there does not appear to be any improvement to the technology of MRI scanning recited.
“and at least one assessment unit for generating an assessment relating to an aspect of periodontal health of the individual based on the analyzed MRI data;” does not integrate into a practical application, while apparently being performed on a computer as noted above, describes the mental process performed in the preamble of the claims and is the material which directs us toward the claim potentially being a Mental Process. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited.
“and an output unit for outputting the assessment generated by the at least one assessment unit” does not integrate into a practical application, as it is assumed a generic computer or processor would contain an output unit such as a console or screen to create the MR images scanned in. Therefore, there does not appear to be any improvement to the technology of MRI scanning recited.
With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C. 101.
Regarding Claim 3, the claim recites: “An apparatus according to claim 1,”, see rejection of Claim 1 stepping through Steps 2A and 2B, and therefore to start with Claim 3 we see Prong One is met of Step 2A. In Prong Two, “wherein the at least one assessment unit includes an inflammation assessment unit that determines, from the analyzed MRI data, inflammation of the gum tissue” does not integrate into a practical application, while apparently being performed on a computer as noted above, describes the mental assessment being performed by the dentist. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C. 101.
Regarding Claim 8, the claim recites: “An apparatus according to claim 1,”, see rejection of Claim 1 stepping through Steps 2A and 2B, and therefore to start with Claim 8 we see Prong One is met of Step 2A. In Prong Two, “further comprising a user interface including a display device configured to display the assessment output by the output unit” does not integrate into a practical application, while apparently being performed on a computer as noted above, it describes the mental assessment being performed by the dentist simply being output by a computer. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore, after Step 2B, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C. 101.
Regarding Claim 9, the claim recites: “An apparatus according to claim 8,” see rejection of Claim 8 stepping through Steps 2A and 2B, and therefore to start with Claim 9 we see Prong One is met of Step 2A. In Prong Two, “wherein the display device is configured to render an image generated from the MRI data” does not integrate into a practical application. It describes the Magnetic Resonance Image data simply being output by a computer. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore after Step 2B, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C. 101.
Regarding Claim 10, the claim recites: “An apparatus according to claim 1,” see rejection of Claim 1 stepping through Steps 2A and 2B, and therefore to start with Claim 10 we see Prong One is met of Step 2A. In Prong Two, “further comprising an assessment scoring unit that determines a score indicative of the aspect of periodontal health of the individual based on the assessment of the analyzed MRI data by the at least one assessment unit” does not integrate into a practical application, while apparently being performed on a computer as noted above, it describes the mental assessment being performed by the dentist simply being output by a computer with a score. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore after Step 2B, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C. 101.
Regarding Claim 11, the claim recites: “An apparatus according to claim 10,” see rejection of Claim 10 stepping through Steps 2A and 2B, and therefore to start with Claim 11 we see Prong One is met of Step 2A. In Prong Two, “wherein the score is determined based on a comparison of the assessment by the at least one assessment unit and a previous assessment of the individual” does not integrate into a practical application, while apparently being performed on a computer as noted above, it describes the mental assessment being performed by the dentist simply being output by a computer with a score and further qualifies the typical mental process performed by the dentist. It is assumed a dentist is capable of recalling a previous appointment in providing diagnosis either through notes or in the mind alone. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore after Step 2B, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C. 101.
Regarding Claim 12, the claim recites: “An apparatus according to claim 10,” see rejection of Claim 10 stepping through Steps 2A and 2B, and therefore to start with Claim 12 we see Prong One is met of Step 2A. In Prong Two, “wherein the score is in the form of at least one of a number that is relative to a given number scale and a color that is relative to a given color scale” does not integrate into a practical application, while apparently being performed on a computer as noted above, it describes the mental assessment being performed by the dentist simply being output by a computer with a score and color. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore after Step 2B, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C 101.
Regarding Claim 13, the claim recites: “A system comprising: the apparatus according to claim 1”, see rejection of Claim 10 stepping through Steps 2A and 2B, and therefore to start with Claim 13 we see Prong One is met of Step 2A. In Prong Two, “and an MRI scanning machine operatively linked to the apparatus such that MRI data from the MRI scanning machine is transmitted to the apparatus” does not integrate into a practical application, while apparently being performed on a computer as noted above, it is the conventional deployment of a typical MRI scanner. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore after Step 2B, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C 101.
Regarding Claim 14, it is rejected for containing similar limitations to Claim 1 above.
Regarding Claim 16, it is rejected for containing similar limitations to Claim 10 above.
Regarding Claim 17, it is rejected for containing similar limitations to Claim 11 above.
Regarding Claim 18, it is rejected for containing similar limitations to Claim 12 above.
Regarding Claim 19, the claim recites: “A method according to claim 14,” see rejection of Claim 14 stepping through Steps 2A and 2B, and therefore to start with Claim 19 we see Prong One is met of Step 2A. In Prong Two, “wherein the MRI data is analyzed using quantitative mapping to thereby provide the assessment as inflammation of gum tissue” does not integrate into a practical application, while apparently being performed on a computer as noted above, it describes the mental assessment being performed by the dentist simply being output by a computer with a score and further qualifies the typical mental process performed by the dentist. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore after Step 2B, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C. 101.
Regarding Claim 20, it is rejected for containing similar limitations to Claim 9 above.
Regarding Claim 21, the claim recites: “A method according to claim 14,” see rejection of Claim 14 stepping through Steps 2A and 2B, and therefore to start with Claim 19 we see Prong One is met of Step 2A. In Prong Two, “wherein an MRI contrast agent is used in conjunction with the scan” does not integrate into a practical application, while apparently being performed on a computer as noted above, it is the conventional deployment of a typical MRI scanner. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore after Step 2B, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C 101.
Regarding Claim 23, the claim recites: “A method according to claim 14, see rejection of Claim 14 stepping through Steps 2A and 2B, and therefore to start with Claim 19 we see Prong One is met of Step 2A. In Prong Two, “wherein a longitudinal assessment of inflammation scores or pocket depth determinations are provided” does not integrate into a practical application, while apparently being performed on a computer as noted above, it describes the mental assessment being performed by the dentist simply being output by a computer with a score and further qualifies the typical mental process performed by the dentist. Further, no specific limitations which show technological improvements to MRI scanning or the analysis of such data appear to be recited. With all limitations considered for Step 2A Prong Two, it appears the Abstract Idea of a Mental Process is not incorporated into a practical application and should continue to Step 2B. In Step 2B, the material as discussed above in Prong Two of Step 2A is re-evaluated, it appears the claim as a whole is directed toward one of “Examples that the courts have indicated may not be sufficient to show an improvement… iii) Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” See MPEP 2106.05(a) II: Improvements to Any Other Technology or Technical Field. Therefore after Step 2B, it appears the claim as a whole does not recite additional elements that amount to significantly more than the judicial exception. The claim does not contain eligible subject matter under 35 U.S.C. 101.
Regarding Claim 25, it is rejected for containing similar limitations to Claim 1 above.
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.
Claims 1-20 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Probst et al (“Magnetic resonance imaging as a diagnostic tool for periodontal disease: A prospective study with correlation to standard clinical findings—Is there added value?”) in view of Raslambekov et al. (US Patent No. 10856954 B1)
Regarding Claim 1, Probst discloses An apparatus (Examiner’s Note, referring to the Summary for a disclosure of this specific apparatus, which is a computer. “When the programs are executed by a computer, the computer functions as an MRI data receiving unit for receiving MRI data that was generated using an MRI scanning machine, the MRI data having been generated from a scan of an oral area of the individual, and the oral area including at least part of teeth, gum tissue, and a bone of the individual; an MRI analysis unit for generating analyzed MRI data in which at least one of hard tissue, soft tissue, a transition area between two tissues, and a transition area between tissue and an anatomical abnormality is identified; at least one assessment unit for generating an assessment relating to an aspect of periodontal health based on the analyzed MRI data; and an output unit for outputting the assessment generated by the at least one assessment unit.”. Therefore, it appears the apparatus and respective units within the application are simply software or programs running on a computer which receives data from an MRI scanner. Note “3 T MRI Scanner”, see Section 2.2 MRI Imaging) for providing an assessment related to an aspect of periodontal health of an individual (See Figure 1, showing MRI sequences from the scanner and color-coded arrows pointing to respective aspects of periodontal health of individuals shown. Specifically, a control healthy patient in figure 1A, and a patient suffering from periodontitis in Figure 1B shown by red arrows where the presence of periodontitis is an aspect of periodontal health), the apparatus comprising: an MRI data receiving unit for receiving MRI data that was generated using an MRI scanning machine (Also note paragraph 0016: “The computer 102 that receives the MRI data from the MRI machine 104 may be a general or special purpose computer.” Note 3 T MRI Scanner, see Section 2.2 MRI Imaging where the 3T scanner is described as being coupled to a 16 channel neck or cervical spine array. Also note software used “Medical Imaging Software Kit” used to draw Figures such as Figure 2 from such MRI scans), the MRI data having been generated from a scan of an oral area of the individual (Referring to Figure 1, we can see the MRI scans of oral areas of individuals including the previously described control or healthy individual in Figure 1A and the patient suffering periodontitis in Figure 1B describing bone loss to the molar teeth, an oral area of the individual), and the oral area including at least part of teeth, gum tissue, and a bone of the individual (Referring to Figure 1, we see “healthy trabecular bone” with dark signal values and the middle dental pulp of the teeth showing high intensity as well as the surrounding gum tissues shown in lighter colors); an MRI analysis unit (Note “Statistical Analysis”, see Section 2.4 Statistical Analysis where a separate software is described, The G-Power Calculator Version 3.1, to perform the tooth and site level statistical analysis. In paragraph 3 of this section, it is described this analysis is used to determine the impact of pocket depth measurements and the presence of oedema) for generating analyzed MRI data in which at least one of hard tissue, soft tissue, an anatomical abnormality, a transition area between two tissues, and a transition area between tissue and an anatomical abnormality is identified (Referring to Figure 1, as noted above hard tissues such as bone or teeth are described, transition between two tissues such as dental pulp or surrounding gum tissues are also shown. However, we also see in Figure 2 anatomical abnormalities and transitions between tissues such as bone and anatomical abnormalities are described by the bone loss areas and the oedema colored in yellow and red respectively in Figures 2A-2C); and at least one assessment unit for generating an assessment relating to an aspect of periodontal health of the individual based on the analyzed MRI data (Note “periodontitis”, see Section 2.4 Statistical Analysis paragraphs 1-2 describing the periodontitis diagnosis or assessment of periodontitis affected teeth using bone loss or probing depths gathered from MRI) ; and an output unit for outputting the assessment generated by the at least one assessment unit (Also note software used “the open-source Software, Medical Imaging Interaction Toolkit MITK, v2018.04.2” used to create figures such as Figure 2. Recalling the specification describes these units specifically as being software programs run on a computer and the software was used to draw the respective bone loss and oedema areas). However, Probst fails to disclose at least one processor configured to read out and execute instructions stored in at least one memory to thereby cause the apparatus to function.
Instead, Raslambekov discloses at least one processor configured to read out and execute instructions (Reference “processor 850” and “memory 870”, see Column 15 Rows 45-50, describing a processor executing instructions which were loaded onto a RAM) stored in at least one memory (Reference “solid state drive 860” and “memory 870”, see Column 15 Rows 45-50, describing a solid state drive storing instructions which are then loaded onto a RAM) to thereby cause the apparatus to function (Reference “computer system” 710”, see Column 13 Rows 50-55 where a computing system can receive image data and see Column 14 Rows 10-20 where the image data may be MR images). The implementation of an MRI scanning machine onto a computer with a processor executing instructions stored in a memory which cause an MRI apparatus to function is the typical use case of an MRI scanning machine. Therefore, KSR Rationale A would provide motivation to these claim limitations as “a combination of prior art elements according to known methods to yield predictable results” would describe the known combination of MRI machines and computers seen in the medical field to allow conversion, display, and analysis of MRI images on a computer screen. Therefore, it would have been obvious before the effective filing date to modify Probst in view of Raslambekov with a generic computer to run the software kits used by Probst.
Regarding Claim 2, Probst discloses An apparatus according to claim 1, wherein the at least one assessment unit includes a pocket depth assessment unit that determines, from the analyzed MRI data, depths of dental pockets (See Figure 3 where the oedema associated with dental pockets are shown. The Volume specifically is extracted, and the measurements in relation to the tooth and gum tissue are shown in Figure 3D) that extend from areas at a top of the gum tissue to areas where the teeth enter the bone (Returning to Figure 3D, Specifically noting the oedema shown as well as the red area as well as the arrow lengths showing total tooth length to the bottom of the root as well as length from crown to the base of the oedema).
Regarding Claim 3, Probst discloses An apparatus according to claim 1, wherein the at least one assessment unit includes an inflammation assessment unit that determines, from the analyzed MRI data, inflammation of the gum tissue (See Section 4 Discussion paragraph 2 where the T2 STIR MRI sequence detects inflammatory lesions and see Figure 4 showing such lesions in the T2 STIR image).
Regarding Claim 4, Probst discloses An apparatus according to claim 1, wherein the at least one assessment unit includes (i) pocket depth assessment unit that determines, from the analyzed MRI data, depths of dental pockets (See Figure 3 where the oedema associated with dental pockets are shown. The Volume specifically is extracted, and the measurements in relation to the tooth and gum tissue are shown in Figure 3D) that extend from areas at a top of the gum tissue to areas where the teeth enter the bone (Returning to Figure 3D, Specifically noting the oedema shown as well as the red area as well as the arrow lengths showing total tooth length to the bottom of the root as well as length from crown to the base of the oedema), and (ii) an inflammation assessment unit that determines, from the analyzed MRI data, inflammation of the gum tissue (See Section 4 Discussion paragraph 2 where the T2 STIR MRI sequence detects inflammatory lesions and see Figure 4 showing such lesions in the T2 STIR image).
Regarding Claim 5, Probst discloses An apparatus according to claim 4, wherein the at least one assessment unit includes an inflammation assessment unit that determines, from the analyzed MRI data, inflammation of the gum tissue (See Section 4 Discussion paragraph 2 where the T2 STIR MRI sequence detects inflammatory lesions and see Figure 4 showing such lesions in the T2 STIR image) and whether the inflammation is acute or chronic (Examiner’s Note: While the Specification shows quite clear details of how a determination of whether inflammation is acute or chronic by specific signal changes in MRI Sequences, there is not a specific definition of acute or chronic inflammations. An assumption has been taken by the examiner this would describe short-term vs long-term inflammation. Returning to Probst, they describe extensive side effects of the periodontitis described, specifically bone or tooth loss induced by periodontitis appeared to be chronic periodontitis inflammation effects or symptoms. Probst shows these in the T1 MRI Sequence in Figure 1C. Also see Table 5 describing the varieties of periodontitis detected, specifically noting the 9th column describing tooth loss due to periodontitis)
Regarding Claim 6, Probst discloses An apparatus according to claim 5, wherein the MRI data includes data from T1- weighted and T2-weighted scans (Reference “T2 STIR Sequence” and “3D T1 Black Bone Sequence”, see Figure 1A showing healthy tissues of control patient in T2 STIR Sequence. See Figure 1B showing another T2 STIR Sequence this time of a patient with periodontitis. Finally note the 3D T1 Black Bone Sequence of a patient with periodontitis in Figure 1C), and the MRI analyzed data includes T1-weighted and T2- weighted analyzed data derived from the MRI data from the T1-weighted and T2-weighted scans (Reference “T2 STIR Sequence” and “3D T1 Black Bone Sequence”, see Figure 1A showing healthy tissues of control patient in T2 STIR Sequence. See Figure 1B showing another T2 STIR Sequence this time of a patient with periodontitis noting the arrows placed in analysis. Finally note the 3D T1 Black Bone Sequence of a patient with periodontitis in Figure 1C noting the arrows placed in analysis), and wherein the inflammation assessment unit determines whether the inflammation of the gum tissue is acute or chronic from the T1-weighted and T2-weighted analyzed data (Returning to Figures 1B and 1C showing the T2 and T1 sequences respectively, the T2 sequence plainly denotes areas with increased signal near the molar teeth in the patient suffering periodontitis. Absent strict definitions of acute versus chronic inflammations, it appears tooth or bone loss due to periodontitis would describe a chronic inflammation and therefore the T1 sequence is also necessary in making this determination of which T2-positive areas might have bone loss. This area specifically is converted into a more familiar display for clinicians.).
Regarding Claim 7, Probst discloses An apparatus according to claim 4, but fails to disclose wherein the at least one assessment unit further comprises a teeth embedded assessment unit that determines, from the analyzed MRI data, distances from areas where the teeth enter the bone to bottoms of roots of the teeth in the bone. Instead, Raslambekov discloses wherein the at least one assessment unit further comprises a teeth embedded assessment unit that determines, from the analyzed MRI data, distances from areas where the teeth enter the bone to bottoms of roots of the teeth in the bone (Reference “root portion 28”, see Column 10 Rows 45-55 for a definition of the root portion which is measured where the root portion extends to the alveolar bone and is also surrounded by the periodontal ligament which is also shown by Figure 3. Also see Column 23 Rows 15-25 where the root portion height is determined. See Table 1 which shows the total tooth height and the root portion height of the tooth. In relation to the aspects of bone loss and oedemas, Raslambekov provides motivation in the form of additional functionality for these assessments of periodontal health providing more specific measurements to the teeth and periodontal structures supporting it (see Column 10 Rows 45-55 describing these periodontal ligaments supporting and surrounding the teeth along with the alveolar bone) these considerations of the structure are important when brackets and wires are installed for orthodontic treatments, there is a deforming force placed on the periodontal ligament (see Column 10 Rows 60-67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Probst in view of Raslambekov to be able to help plan such treatments.
Regarding Claim 8, Probst discloses An apparatus according to claim 1, but fails to disclose further comprising a user interface including a display device configured to display the assessment output by the output unit. Instead, Raslambekov discloses further comprising a user interface including a display device configured to display the assessment output by the output unit (Reference “computing system 710” and “interface device 720”, see Column 15 Row 65 to Column 16 Row 5 where the interface device may be a monitor which is a display for displaying the outputs in any form such as images or 3D models for example). The implementation of an MRI scanning machine onto a computer with a display which causes an MRI apparatus to function is the typical use case of an MRI scanning machine. KSR Rationale A would apply to these claim limitations as “a combination of prior art elements according to known methods to yield predictable results” would describe the known combination of MRI machines and computers seen in the medical field to allow conversion, display, and analysis of MRI images on a computer screen. Therefore, it would have been obvious before the effective filing date to modify Probst in view of Raslambekov with a generic computer with a display to run and show the software kit results used by Probst.
Regarding Claim 9, Probst discloses An apparatus according to claim 8, but fails to disclose wherein the display device is configured to render an image generated from the MRI data. Instead, Raslambekov discloses wherein the display device is configured to render an image generated from the MRI data (Reference “computing system 710” and “interface device 720”, see Column 15 Row 65 to Column 16 Row 5 where the interface device may be a monitor which is a display for providing outputs and may provide an output of any form such as image or 3D models for example. Also recall the use of magnetic resonance images by the computing system as described in rejection of Claim 1). The implementation of an MRI scanning machine onto a computer with a display which causes an MRI apparatus to function is the typical use case of an MRI scanning machine. KSR Rationale A would apply to these claim limitations as “a combination of prior art elements according to known methods to yield predictable results” would describe the known combination of MRI machines and computers seen in the medical field to allow conversion, display, and analysis of MRI images on a computer screen. Therefore, it would have been obvious before the effective filing date to modify Probst in view of Raslambekov with a generic computer with a display to run and show the software kit results used by Probst.
Regarding Claim 10, Probst discloses An apparatus according to claim 1, further comprising an assessment scoring unit that determines a score indicative of the aspect of periodontal health of the individual based on the assessment of the analyzed MRI data by the at least one assessment unit (Note “oedema”, and “probing depth”, see Table 1 where size of oedema mean is provided as a score of various respective patients’ health and the coincidence of the oedema found in MRI is shown vs the clinical probing depth)
Regarding Claim 11, Probst discloses An apparatus according to claim 10, wherein the score is determined based on a comparison of the assessment by the at least one assessment unit and a previous assessment of the individual(Note “oedema”, and “probing depth”, see Table 1 where size of oedema mean is provided as a score of various patient health and the coincidence of the oedema found in MRI is shown vs the clinical probing depth. Specifically this clinical probing depth is gathered before the MRI scan, as noted in Section 2.1 Study design paragraph 1 where a standard clinical periodontal exam is performed to gather these clinical probing depths.).
Regarding Claim 12, Probst discloses An apparatus according to claim 10, wherein the score is in the form of at least one of a number that is relative to a given number scale and a color that is relative to a given color scale (Note “oedema”, and “probing depth”, see Table 1 where size of oedema mean is provided as a score of various patient healths and the coincidence of the oedema found in MRI is shown vs the clinical probing depth. Also note the MRI scans where the oedemas and bone losses due to the periodontal health of the individual is shown in Figures 2A-C where these color coding for oedema presence are shown individually and also overlaid on the same image).
Regarding Claim 13, Probst discloses A system comprising: the apparatus according to claim 1; and an MRI scanning machine operatively linked to the apparatus such that MRI data from the MRI scanning machine is transmitted to the apparatus (Note 3 T MRI Scanner, see Section 2.2 MRI Imaging where the 3T scanner is described as being coupled to a 16 channel neck or cervical spine array. The scan itself is more completely described with the specific T1 and T2 sequences issued by the apparatus with the scanning machine as well as how the sequences Also note software used “Medical Imaging Software Kit” used to draw Figures such as Figure 2 from such MRI scans showing the software is configured in a way such that MRI data from the MRI scanning machine has been transmitted to it).
Regarding Claim 14, Probst discloses A method (Note “Methods”, See Section 2 Methods describing the methods of patient examination in clinical examination in Section 2.1 and the method of MRI imaging in Section 2.2 describing use of the MRI scanner for examining all of the patients specifically the sequence protocols used) of assessing an aspect of the periodontal health of an individual (See Figure 1, showing MRI sequences from the scanner and color-coded arrows pointing to respective aspects of periodontal health of individuals shown. Specifically, a control healthy patient in figure 1A, and a patient suffering from periodontitis in Figure 1B shown by red arrows where the presence of periodontitis is an aspect of periodontal health), the method comprising: using an MRI scanning machine (Note 3 T MRI Scanner, see Section 2.2 MRI Imaging where the 3T scanner is described as being coupled to a 16 channel neck or cervical spine array) to scan an oral area of an individual to thereby generate MRI data (Referring to Figure 1, we can see the MRI scans of oral areas of individuals including the previously described control or healthy individual in Figure 1A and the patient suffering periodontitis in Figure 1B describing bone loss to the molar teeth, an oral area of the individual), the oral area including at least part of teeth, gum tissue, and a bone of the individual (Referring to Figure 1, we see “healthy trabecular bone” with dark signal values and the middle dental pulp of the teeth showing high intensity as well as the surrounding gum tissues shown in lighter colors); analyzing the MRI data to thereby generate analyzed MRI data (Note “Statistical Analysis”, see Section 2.4 Statistical Analysis where a separate software is described, The G-Power Calculator Version 3.1, to perform the tooth and site level statistical analysis. In paragraph 3 of this section, it is described this analysis is used to determine the impact of pocket depth measurements and the presence of oedema) in which at least one of hard tissue, soft tissue, an anatomical abnormality, a transition area between two tissues, or a transition area between tissue and an anatomical abnormality is identified, the analysis being performed by a computer (Note “Medical Imaging Software Kit”, see Section 2.2 MRI Imaging used to draw Figures such as Figure 2 from such MRI scans); and providing an assessment of periodontal heath of the individual based on the analyzed MRI data (Referring to Figure 1, as noted above hard tissues such as bone or teeth are described, transition between two tissues such as dental pulp or surrounding gum tissues are also shown. However, we also see in Figure 2 anatomical abnormalities and transitions between tissues such as bone and anatomical abnormalities are described by the bone loss areas and the oedema colored in yellow and red respectively in Figures 2A-2C. Finally also noting the Figure in Figure 2 is generated using the “Medical Imaging Software Kit” as well as the G-Power Calculator software previously described shows the analysis and assessments are performed on or by a computer with such software). However, Probst fails to disclose the analysis being performed by a computer and the assessment being provided by the computer.
Instead, Raslambekov discloses the analysis being performed by a computer (Reference “computing system 710” see Column 13 Rows 25-35 where analysis such as the tooth axis used for determining tooth length and other measurements is performed by the computing system 710) the assessment being provided by the computer (Reference “periodontal anomalies”, see Column 14 Rows 1-10 where the measurements in turn may indicate periodontal anomalies to factor into the treatment plan). The implementation of an MRI scanning machine onto a generic computer for displaying MRI images and performing analysis or assessment of MRI scans on or by said generic computer. Therefore, KSR Rationale A would provide motivation to these claim limitations as “a combination of prior art elements according to known methods to yield predictable results” would describe the known combination of MRI machines and computers seen in the medical field to allow conversion, display, and analysis of MRI images on a computer screen. Therefore, it would have been obvious before the effective filing date to modify Probst in view of Raslambekov with a generic computer to run the software kits used by Probst.
Regarding Claim 15, Probst discloses A method according to claim 14, wherein the assessment is at least one of (i) depths of dental pockets that extend from areas at a top of the gum tissue to areas where the teeth enter the bone (See Figure 3 where the oedema associated with dental pockets are shown. The Volume specifically is extracted, and the measurements in relation to the tooth and gum tissue are shown in Figure 3D) that extend from areas at a top of the gum tissue to areas where the teeth enter the bone (Returning to Figure 3D, Specifically noting the oedema shown as well as the red area as well as the arrow lengths showing total tooth length to the bottom of the root as well as length from crown to the base of the oedema), and (ii) inflammation of the gum tissue, (See Section 4 Discussion paragraph 2 where the T2 STIR MRI sequence detects inflammatory lesions and see Figure 4 showing such lesions in the T2 STIR image), but fails to disclose and (iii) distances from areas where the teeth enter the bone to bottoms of roots of the teeth in the bone.
Instead, Raslambekov discloses (iii) distances from areas where the teeth enter the bone to bottoms of roots of the teeth in the bone (Reference “root portion 28”, see Column 10 Rows 45-55 for a definition of the root portion which is measured where the root portion extends to the alveolar bone and is also surrounded by the periodontal ligament which is also shown by Figure 3. Also see Column 23 Rows 15-25 where the root portion height is determined. See Table 1 which shows the total tooth height and the root portion height of the tooth.) In relation to the aspects of bone loss and oedemas, Raslambekov provides motivation in the form of additional functionality for these assessments of periodontal health providing more specific measurements to the teeth and periodontal structures supporting it (see Column 10 Rows 45-55 describing these periodontal ligaments supporting and surrounding the teeth along with the alveolar bone) these considerations of the structure are important when brackets and wires are installed for orthodontic treatments, there is a deforming force placed on the periodontal ligament (see Column 10 Rows 60-67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Probst in view of Raslambekov to be able to help plan such treatments.
Claim 16 is rejected for containing similar limitations to those described under the rejection of Claim 10 described above.
Claim 17 is rejected for containing similar limitations to those described under the rejection of Claim 11 described above.
Claim 18 is rejected for containing similar limitations to those described under the rejection of Claim 12 described above.
Regarding Claim 19, Probst discloses A method according to claim 14, wherein the MRI data is analyzed using quantitative mapping to thereby provide the assessment as inflammation of gum tissue (See Table 1 showing the correlations between the pocket depths normally used to describe inflammation of the gum tissue and the presence of the oedema where any inflammation greater than 1mm coincides with oedema presence and greater oedema size also mapped to a greater pocket depth which describes a quantitative mapping in the data).
Claim 20 is rejected for containing similar limitations to those described under the rejection of Claim 8 described above.
Regarding Claim 24, Probst discloses A method according to claim 14, where anatomical information is derived from the analyzed MRI data (See Figures 2A-2C where presence of bone loss and oedema are derived from the MRI data), but fails to disclose with the anatomical information identifying a long axis of a distinct tooth, and wherein a distance from an area where the distinct tooth enters the bone to a bottom of a root of the distinct tooth is assessed by evaluating signal variations around the distinct tooth as a function of position along the long axis of the distinct tooth.
Instead, Raslambekov discloses with the anatomical information identifying a long axis of a distinct tooth (See Figure 3 showing the axis of the tooth being taken. Specifically described in Column 18 Rows 25-35 as the Z-axis which would point up if taken from the lower teeth which would be the long axis of the tooth ), and wherein a distance from an area where the distinct tooth enters the bone to a bottom of a root of the distinct tooth is assessed by evaluating (Reference “root portion 28”, see Column 10 Rows 45-55 for a definition of the root portion which is measured where the root portion extends to the alveolar bone and is also surrounded by the periodontal ligament which is also shown by Figure 3. Also see Column 23 Rows 15-25 where the root portion height is determined. See Table 1 which shows the total tooth height and the root portion height of the tooth) signal variations around the distinct tooth as a function of position along the long axis of the distinct tooth (See Figure 10 showing the 3D Crown model is dissected by the mesiodistal plane used to determine the intersection curve in determining the tooth axis of the tooth). In relation to the aspects of bone loss and oedemas, Raslambekov provides motivation in the form of additional functionality for these assessments of periodontal health providing more specific measurements to the teeth and periodontal structures supporting it (see Column 10 Rows 45-55 describing these periodontal ligaments supporting and surrounding the teeth along with the alveolar bone) these considerations of the structure are important when brackets and wires are installed for orthodontic treatments, there is a deforming force placed on the periodontal ligament (see Column 10 Rows 60-67). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Probst in view of Raslambekov to be able to help plan such treatments.
Regarding Claim 25, Probst discloses An MRI data receiving unit for receiving MRI data that was generated using an MRI scanning machine (Also note paragraph 0016: “The computer 102 that receives the MRI data from the MRI machine 104 may be a general or special purpose computer.” Note 3 “T MRI Scanner”, see Section 2.2 MRI Imaging where the 3T scanner is described as being coupled to a 16 channel neck or cervical spine array. Also note software used “Medical Imaging Software Kit” used to draw Figures such as Figure 2 from such MRI scans), the MRI data having been generated from a scan of an oral area of the individual (Referring to Figure 1, we can see the MRI scans of oral areas of individuals including the previously described control or healthy individual in Figure 1A and the patient suffering periodontitis in Figure 1B describing bone loss to the molar teeth, an oral area of the individual), and the oral area including at least part of teeth, gum tissue, and a bone of the individual (Note “healthy trabecular bone”, see Figure 1, where there are dark signal values showing the trabecular bone and the middle dental pulp of the teeth showing high intensity as well as the surrounding gum tissues shown in lighter colors); an MRI analysis unit (Note “Statistical Analysis”, see Section 2.4 Statistical Analysis where a separate software is described, The G-Power Calculator Version 3.1, to perform the tooth and site level statistical analysis. In paragraph 3 of this section, it is described this analysis is used to determine the impact of pocket depth measurements and the presence of oedema) for generating analyzed MRI data in which the at least one of hard tissue, soft tissue, an anatomical abnormality, a transition between two tissues, and a transition area between tissue and an anatomical abnormality is identified (Referring to Figure 1, as noted above hard tissues such as bone or teeth are described, transition between two tissues such as dental pulp or surrounding gum tissues are also shown. However, we also see in Figure 2 anatomical abnormalities and transitions between tissues such as bone and anatomical abnormalities are described by the bone loss areas and the oedema colored in yellow and red respectively in Figures 2A-2C); and at least one assessment unit for generating an assessment relating to an aspect of periodontal health of the individual based on the analyzed MRI data (Note “periodontitis”, see Section 2.4 Statistical Analysis paragraphs 1-2 describing the periodontitis diagnosis or assessment of periodontitis affected teeth using bone loss or probing depths gathered from MRI); and an output unit for outputting the assessment generated by the at least one assessment unit (Also note software used “the open-source Software, Medical Imaging Interaction Toolkit MITK, v2018.04.2” used to create figures such as Figure 2. Recalling the specification describes these units specifically as being software programs run on a computer and the software was used to draw the respective bone loss and oedema areas). However, Probst fails to disclose A non-transitory computer readable storage medium storing one or more programs that when executed by a computer cause the computer to function.
Instead, Raslambekov discloses A non-transitory computer readable storage medium storing one or more programs that when executed by a computer cause the computer to function (see Column 15 Rows 45-50, describing a solid state drive storing instructions which are then loaded onto a RAM and a processor executing those instructions which were loaded onto the RAM) to thereby cause the apparatus to function (Reference “computer system” 710”, see Column 13 Rows 50-55 where a computing system can receive image data and see Column 14 Rows 10-20 where the image data may be MR images). The implementation of an MRI scanning machine onto a computer with a processor executing instructions stored in a memory which cause an MRI apparatus to function is the typical use case of an MRI scanning machine. Therefore, KSR Rationale A would provide motivation to these claim limitations as “a combination of prior art elements according to known methods to yield predictable results” would describe the known combination of MRI machines and computers seen in the medical field to allow conversion, display, and analysis of MRI images on a computer screen. Therefore, it would have been obvious before the effective filing date to modify Probst in view of Raslambekov with a generic computer to run the software kits used by Probst.
Claim 26 is rejected for containing similar limitations to those described under the rejection of Claim 4 described above.
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Probst et al (“Magnetic resonance imaging as a diagnostic tool for periodontal disease: A prospective study with correlation to standard clinical findings—Is there added value?”) in view of Raslambekov et al. (US Patent No. 10856954 B1) further in view of Schara et al (“T 1 relaxation time and magnetic resonance imaging of inflamed gingival tissue”)
Regarding Claim 21, Probst discloses A method according to claim 14, but fails to disclose wherein an MRI contrast agent is used in conjunction with the scan. Instead, Schara discloses wherein an MRI contrast agent is used in conjunction with the scan (Note “contrast agent”, see Section “Materials and Methods” paragraph 2 where the contrast agent was injected before the post-contrast T1 weighted scan). A motivation is provided by Schara as well where “the contrast agent accumulates in inflamed tissues and enhances mainly the signal intensity of those tissue” (See Section “Introduction paragraph 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Probst in view of Schara so that the T1 scan would enhance these inflamed tissues attempting to be diagnosed.
Regarding Claim 23, Probst discloses A method according to claim 14, but fails to disclose wherein a longitudinal assessment of inflammation scores or pocket depth determinations are provided. Instead, Schara discloses wherein a longitudinal assessment of inflammation scores or pocket depth determinations are provided (Examiner’s Note: No strict definition of longitudinal assessment was provided, but this was assumed in the medical field to mean a set of historical scores. Returning to Schara, see Figure 2 where images are acquired before a treatment and 3 months after a treatment are shown top vs bottom. The far right picture shows only the signal of the contrast agent which as previously noted would highlight the inflamed tissues. Further, noting Figure 3 we see how the RSI signal intensity is implemented as a longitudinal assessment of inflammation scores. We also see a set of pocket depth determinations in before and after format which would also constitute a longitudinal assessment of pocket depth determinations). A motivation is provided by Schara as well where “after the therapy there will be a reduction in inflammation that can be confirmed by a reduction of the ratio of signal intensities (RSI) values in those tissues” (See Introduction paragraph 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Probst in view of Schara so that the reduction in inflammation can be confirmed in the treatment plan.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Probst et al (“Magnetic resonance imaging as a diagnostic tool for periodontal disease: A prospective study with correlation to standard clinical findings—Is there added value?”) in view of Raslambekov et al. (US Patent No. 10856954 B1) further in view of Ludwig et al (“Dental MRI using wireless intraoral coils”)
Regarding Claim 22, Probst discloses A method according to claim 14, but fails to disclose wherein an intra-oral radiofrequency coil is used in conjunction with the scan. Instead, wherein an intra-oral radiofrequency coil is used in conjunction with the scan. Instead, Ludwig discloses wherein an intra-oral radiofrequency coil is used in conjunction with the scan (See Figure 8 showing MRI results and comparison of using an intra-oral coil and not where the Figures A-C show with a coil and D-F show without the coil). Instead, wherein an intra-oral radiofrequency coil is used in conjunction with the scan. Ludwig also discloses the motivation for such modifications (See Figure 8 as noted above where the signal is enhanced in the comparison between with and without the coils. Also See Section “Comparison to other MRI coils”, which describes an improved resolution using the coil) where the local sensitivity of the intraoral coils gave stronger resolution. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Probst in view of Ludwig to improve the resolution of the MRI scan with intraoral coils.
Conclusion
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/ALEXANDER JOHN RODGERS/Examiner, Art Unit 2661
/JOHN VILLECCO/Supervisory Patent Examiner, Art Unit 2661
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