DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Responsive to the communication dated 10/09/2025
Claims 21-22, 25, 29-31, 34, 38-53 are presented for examination
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/09/2025 has been entered.
Response to Arguments – 112
Applicant’s arguments, see page 13, filed 10/09/2025, with respect to the previous rejections of claims 30-31 and 34 under 112 have been fully considered and are persuasive. The previous rejections of claims 30-31 and 34 under 112 has been withdrawn.
It should be noted, however, that the substantial new amendments have introduced several new issues under 112 leading to new rejections of these claims.
Response to Arguments – 101
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
Applicant argues that the amended claims integrate the abstract idea into a practical application, specifically by allowing surgical instrumentation to fit into a patient’s mouth
Examiner responds by explaining that the determination of whether the surgical instrumentation fits in the patient’s mouth, i.e. the inventive thrust of the claims is a mental process. Determining whether an object will fit in a particular space is a mental process equivalent to observing both the object and space and judging if the object will fit within the space. This can be done by pre-verbal toddlers, as by determining if a square peg will fit in a round or square hole.
The use of processors and specifying that several elements are “virtual” or “digital” amounts to no more than mere instructions to apply this judicial exception. Very little structure is recited when describing the additional elements, particularly the computer elements, that would suggest they were anything more than generic. For example, there is not enough particularity in the claims to conclude that the virtual model of the patient’s mouth is something other than an ordinary model.
Additionally:
Generating a 3D model from a CT or CB scan amounts to no more than mere data gathering. Further, generating a 3D model from a CT or CB scan is also an example of a well-understood, routine, conventional activity.
Quantitative Evaluation of the Accuracy of Micro-Computed Tomography in Tooth Measurement ([Page 2 Col 1 Par 2- Col 2 Par 1])
Three-dimensional analysis of mandibular growth and tooth eruption ([Page 671 Col 1 Par 1])
Dental CT Imaging as a Screening Tool for Dental Profiling: Advantages and Limitations ([Page 115 Col 1 Par 1])
Personal Computer-Based Three-Dimensional Computed Tomographic Images of the Teeth for Evaluating Supernumerary or Ectopically Impacted Teeth ([Figure 2, Figure 8])
Computing the dimensions of the model and comparing those dimensions to that of the tool are merely mental processes, but carried out using a general-purpose computer. For example, a person could mentally observe the tool, make judgments about its size either visually or using a ruler, observe the patient’s mouth and make judgments about its size, again either visually or using a ruler, and mentally compare the sizes to judge whether the tool is too big to fit in the mouth. This kind of basic size and shape comparison is a process human minds are particularly equipped to perform even at an early age, e.g. toys for infants and toddlers that involve multiple holes and pegs of different sizes and shapes and determining which fits where.
The alleged additional details given to this process are either part of the abstract idea itself and therefore incapable of integrating it into a practical solution/providing an inventive concept/significantly more or are insignificant additional elements recited with very little particularity. See further details on the rejections of the newly amended additional elements below:
developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity using axial CT or CB scan data including scan data of a surgical region of the patient's upper or lower jaw to an opposing anatomical region of the patient's other jaw;
Obtaining a 3D model from a 3D scanning technique such as CT or CB scanning amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Should it be found that this is not a mental process, it is also an example of a well-understood, routine, conventional activity (WURC). See below:
Quantitative Evaluation of the Accuracy of Micro-Computed Tomography in Tooth Measurement ([Page 2 Col 1 Par 2- Col 2 Par 1])
Three-dimensional analysis of mandibular growth and tooth eruption ([Page 671 Col 1 Par 1])
Dental CT Imaging as a Screening Tool for Dental Profiling: Advantages and Limitations ([Page 115 Col 1 Par 1])
Personal Computer-Based Three-Dimensional Computed Tomographic Images of the Teeth for Evaluating Supernumerary or Ectopically Impacted Teeth ([Figure 2, Figure 8])
receiving, by a processor operably coupled to a memory device, and from the 3D virtual model, spatial constraint data of the patient's oral cavity, wherein the spatial constraint data represents spatial constraints imposed by anatomical structures of the patient's oral cavity and includes at least one anatomical dimension measured from the surgical region to the opposing anatomical region; … determining, by the processor, a height dimension in the 3D virtual model between a top of the virtual surgical guide and the opposing anatomical region; and
Receiving and determining this data is equivalent to gathering generic measurement data in a generic manner, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
causing, by the processor, the 3D virtual model to be displayed on an electronic display device and in a human-readable format to one or more parties responsible for placement of the at least one candidate dental implant in the patient's open mouth;
This step merely presents the results of the mental process of generating the model, and therefore amounts to no more than insignificant post-solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
providing, by the processor and based on the prediction, human-readable information to one or more parties responsible for placement of the at least one candidate dental implant in the patient's open mouth, the human-readable information including: guidance about whether the digital surgical plan should be altered with a variation to one or more of the at least one candidate dental implant, the virtual surgical guide, and at least one surgical instrument selected for use from the one or more candidate surgical instruments prior to manufacture of the actual surgical guide and performance of the actual surgical plan for the patient.
This step merely presents the results of the mental process of determining whether or not the tool fits, and therefore amounts to no more than insignificant post-solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity
Applying a computer to create a generic 3D model at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that model creation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the model is “developed” without reciting how this development is actually accomplished.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
positioning, by the processor and in the 3D virtual model, the virtual surgical guide in the opposing anatomical region of the 3D virtual model and aligned with a planned implant location for the at least one candidate dental implant;
Applying a computer to position a virtual object at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that positioning, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the guide is placed opposing and aligned with the planned implant location without reciting how this virtual positioning is actually accomplished.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
Moreover, Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “A computer-implemented method, comprising: … a digital surgical plan including a virtual surgical guide; a three-dimensional (3D) virtual model of the patient's oral cavity; a processor operably coupled to a memory device; a digital representation of surgical instrumentation data stored in memory;” are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
Applicant argues that supplying the human readable output integrates the claims into a practical solution/providing an inventive concept/significantly more.
Examiner responds by explaining that providing such output, particularly when recited with such little particularity, is equivalent to merely presenting the results of the abstract idea (i.e. whether or not the tool fits and if not deciding if the plan should be changed) and therefore amounts to no more than insignificant extra-solution activity.
Response to Arguments – 103
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
Applicant argues that no prior art teaches “generating a digital surgical plan including a virtual surgical guide for guiding placement of at least one candidate dental implant in a patient's open mouth ...,
wherein determining whether the surgical instrumentation fits within the spatial constraints comprises computing and
providing ...
a prediction of whether the one or more candidate surgical instruments will fit in the patient's oral cavity during execution of the digital surgical plan in a clinical setting with the patient's mouth open and including an actual surgical guide based on the virtual surgical guide”
Examiner responds by explaining that these limitations are taught by the combination of Schmitt (US 20080085489 A1) in view of Fenick (US 5015183 A) in further view of Boerjes (WO 2007084727 A1)
In particular:
Schmitt teaches generating a digital surgical plan ([Par 5] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) including a virtual surgical guide for guiding placement of at least one candidate dental implant in a patient's ([Par 6] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” [Par 59] “FIG. 8C shows the virtual upper cast 45 virtual lower cast 44 and occlusal index 56 with the jaw opened the same amount as in FIG. 8B” [Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants, and manufacturing an actual drill guide based on data of the virtual drill guide.”)
([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) in a clinical setting with the patient's mouth ([Par 67] “Once the virtual drill guide's form and shape are determined, an actual drill guide may be manufactured by, for example, rapid prototyping or cutting with a five axis mill.” [Par 70] “FIG. 11 illustrates the first drill guide 51 in use within the patient's mouth. The first drill guide 51 may be used to place two or more implants 42 and a central guide pin 54. First, the surgeon places the first drill guide 51 in the patient's mouth on the patient's posterior teeth and shapes the jaw bone until the guide 51 seats on the cusps of the posterior teeth. Next the metal tubes 52 in the guide 51 are used to drill holes in the jaw bone at the proper angulation and depth. Actual dental implants 42 may be placed in two or more of the drill sites.”)
Fenick makes obvious ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: determining if a patient’s mouth is too small for a tool to fit involves comparing the dimensions of the patient’s mouth to the dimensions of the tool. Note that determining if there is enough headroom to position the drill to align with the guide sleeve involves measuring the distance between the top of the guide sleeve (an example of a surgical guide) and the dental structures on the opposing jaw])
Boerjes makes obvious dental operations on an open mouth; performing dental operations with the patient's mouth open ([Fig. 1] Shows a dental operation being performed on a patient’s open mouth.)
Applicant argues that the use of Fenick is improper because it merely discloses a real-life scenario that the present claims seek to prevent in the first place, i.e. that a tool is too big to fit in a patient’s mouth.
Examiner responds by explaining that the process described for determining if the tool is too big to fit in the mouth described in Fenick is virtually identical to that disclosed in the claims, the only difference being that in the present claims this process is performed in the context of a model of a mouth rather than an actual patient’s mouth. Regardless, the process itself is the same, i.e. comparing the size of a tool to the size of the patient’s mouth and determining if there is enough room. With the simulation and measurement of a patient’s mouth being taught by Schmitt, the process combination of Schmitt and Fenick brings this simple determination into the context of a virtual model, which teaches the process described by the claims.
Further, it should be noted that in a rejection under 103 using a combination of references, an individual reference need not be directed to the same exact invention as claimed for the same exact purpose as envisioned by the applicant, merely that each reference is analogous art, that there would have been a motivation to combine the references, and that in combination the references teach the features of the claims.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
For completeness, the combination rationale for combining Fenick with Schmitt is provided below:
Fenick is analogous art because it is within the field of dentistry, it would have been obvious to one of ordinary skill in the art to combine Schmitt with Fenick before the time of invention. One of ordinary skill in the art would have been motivated to make this combination in order to better plan dental procedures, particularly in relation to bone structure, and therefore extend implant life and durability. As stated by Fenick, locating sufficient bone structure to anchor an implant to can be an incredibly difficult and fallible process. ([Col 1 line 19-29] “However, a problem in the art and science of placing tooth implants into a patient's mouth was finding or locating sufficient bone structure in which to fix the implant so as to obtain the most optimum results. As the bone structure and/or the density or mass thereof is not readily apparent, implants have frequently been placed into a location where there is insufficient bone structure to form a suitable anchoring position for the implant. The ultimate consequence thereof was a failure of the implant in a relatively brief period of time.”) Fenick points out the need for a system capable of determining an optimal implantation plan to extend implant life. To this end, Fenick presents a comprehensive implantation planning suite capable of determining the optimal location and path of both an implant and the requisite instrumentation for installing said implant. ([Col 1 line 50-66] “Another object is to provide a method for facilitating the drilling of a bore into the most optimal bone structure of a patient's jaw to define the most desirable seat for an implant fixture… Another object is to provide a casting of a patient's teeth formed with a guide for directing a drill along a predetermined trajectory into the most optimal bone structure of a patient's jaw to define the seat for a tooth implant fixture…. Another object is to provide a method and device for accurately transferring the most optimal implant trajectory as determined by an actual oblique X-ray of a patient's jaw to a model of the patient's teeth. [Col 2 line 7- 61] “The foregoing objects and other features and advantages are attained by a method of imbedding a tooth implant into the most optimal bone structure of a patient's tooth by first making a model of a patient's teeth in the vicinity of the implant void. Upon completion of the model, one or more artificial teeth are positioned on the model in the implant void thereon to determine the occlusal and aesthetic positions of the contemplated implant. Upon the determination of the optimum arrangement of the contemplated implants, a casting or stent is made of the model with the artificial teeth in place…. The casting or stent so formed is then placed onto the teeth in the mouth of the patient an a diagnostic evaluation is made of a patient's mouth by taking a series of oblique X-ray views in the vicinity of the implant area to establish a trajectory into the most optimal bone structure for drilling the seat or bore into which the implant fixture is to be anchored… A second casting is made to the patient's model so as to fix the position of the guide sleeve relative to the patient's teeth. With the second casting in place onto one's teeth, the seat for the implant can be precisely drilled into the optimal bone structure as the guide sleeve functions to guide the drill bit along the predetermined trajectory to form the implant seat in the most optimal bone structure.”) Overall, one of ordinary skill in the art would recognize that combining Schmitt with Fenick would result in a system capable of generating better dental procedures in which implants are significantly more durable and last much longer.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Response to Arguments – Double Patenting
Applicant’s arguments, see page 17, filed 10/09/2025, with respect to the rejection of claims 21-40 for Double Patenting have been fully considered and are persuasive. The rejection of claims 21-40 for Double Patenting has been withdrawn.
It should be noted, however, that several of the newly amended limitations that now define the current claims over the other patents (CT or CB scans that are specifically axial, placing the guide on the opposite side of the mouth from the side that is actually receiving surgery, specific use of a 512x512 matrix when scanning, etc.) do not appear to have support in the disclosure. See the rejections under 112 below.
Claim Objections
Claims 21-22, 25, 29-31, 34, and 38-53, objected to because of the following informalities:
The claims have numerous issues with antecedent basis. The Examiner suggests amending the claims such that the first recitation of each distinct element uses articles such as “a”/”an”, later recitations referring back to the same distinct element uses articles such as “the”/”said”, to use disambiguating modifiers (e.g., first, second, etc.) when there are multiple distinct elements with the same base term, and that the use of modifiers for each distinct element is kept consistent. Below is a non-exhaustive list of examples of these issues:
Claim 21 recites the limitation "the spatial data.” This is clearly meant to read “the spatial constraint data” and is interpreted as such for the purposes of this examination.
Claim 21 recites the limitation "virtual surgery guide.” This is clearly meant to read “the virtual surgical guide” and is interpreted as such for the purposes of this examination
Claim 21 recites the limitation " the processor” before later reciting “a processor operably coupled to a memory device” The first recitation of a processor should be introduced as “a processor” with subsequent recitations using the wording “the processor”
Claim 21 recites “the patient’s oral cavity;” as no oral cavity had been previously introduced, this should instead read “an oral cavity of the patient”
Claim 21 recites “the patient’s upper or lower jaw” as no upper or lower jaw had been previously introduced, this should instead read “an upper or lower jaw of the patient”
Claim 21 recites “performance of the actual surgical plan” as no actual surgical plan was previously introduced, this should read “performance of an actual surgical plan”
Claim 30 recites “the patient’s oral cavity;” as no oral cavity had been previously introduced, this should instead read “an oral cavity of the patient”
Claim 30 recites “the patient’s upper or lower jaw” as no upper or lower jaw had been previously introduced, this should instead read “an upper or lower jaw of the patient”
Claim 30 recites “performance of the actual surgical plan” as no actual surgical plan was previously introduced, this should read “performance of an actual surgical plan”
Claim 38 recites “the patient’s oral cavity;” as no oral cavity had been previously introduced, this should instead read “an oral cavity of the patient”
Claim 38 recites “the patient’s upper or lower jaw” as no upper or lower jaw had been previously introduced, this should instead read “an upper or lower jaw of the patient”
Claim 38 recites “performance of the actual surgical plan” as no actual surgical plan was previously introduced, this should read “performance of an actual surgical plan”
Claim 38 recites “the digital model of the surgical instruments.” As no “surgical instruments were previously introduced, this should read “candidate surgical instruments”
Claim 38 recites the limitation “the digital model of the digital model of.” It is clear that this language was not meant to be repeated and should simply read “the digital model of”
Claim 47 recites the limitation " the digital surgical” This is clearly meant to read “the digital surgical plan” and is interpreted as such for the purposes of this examination.
Please note again that this not an exhaustive list.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-22, 25, 29-31, 34, and 38-53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21, 25, 30, 34, 38 and 40-41 recite the use of specifically “axial” CT or CB scan data. There does not appear to be support for a CT or CB scan that specifically capture axial data in the disclosure. Specific axes captured by the CT scan are never specified, with the CT scan being recited in a very generic manner ([Par 7] “Surgical guides can be created by the use of a CT-scan of the patient's mouth. The CT-scan provides enough detail to develop the surgical guide by use of various methods.” [Par 25] “The scanning of the patient's mouth may be achieved by a CT scanner (or other scanning technologies or devices) to obtain scan data regarding the details of the bone structure, teeth and overlying gingival tissue. The first scan 10 usually involves a scanning appliance that is placed in a patient's mouth. As is known in the art, a scanning appliance is used for a partial or fully edentulous patient and includes physical shape information representing the desired prosthetic teeth in the region, usually with added material (e.g., barium sulfate) that can be picked-up by a typical CT scan.” [Par 49] “At step 304, a CT scan is taken of the patient's mouth in the opened position.”)
Further the specific use of a CB or cone-beam scan also appears to lack support, with the closest recitation in the specification merely describing that “other scanning technologies or devices” can be used ([Par 25] “The scanning of the patient's mouth may be achieved by a CT scanner (or other scanning technologies or devices) to obtain scan data regarding the details of the bone structure, teeth and overlying gingival tissue.”)
Claims 25, 34, and 40 recite the use of an axial CT or CB scan specifically with a matrix of 512x512. The use of such a specific matrix size does not appear to be disclosed in the specification, with the CT scan being recited in a very generic manner. ([Par 7] “Surgical guides can be created by the use of a CT-scan of the patient's mouth. The CT-scan provides enough detail to develop the surgical guide by use of various methods.” [Par 25] “The scanning of the patient's mouth may be achieved by a CT scanner (or other scanning technologies or devices) to obtain scan data regarding the details of the bone structure, teeth and overlying gingival tissue. The first scan 10 usually involves a scanning appliance that is placed in a patient's mouth. As is known in the art, a scanning appliance is used for a partial or fully edentulous patient and includes physical shape information representing the desired prosthetic teeth in the region, usually with added material (e.g., barium sulfate) that can be picked-up by a typical CT scan.” [Par 49] “At step 304, a CT scan is taken of the patient's mouth in the opened position.”)
Claims 21, 30, and 38 describe placing/positioning the virtual surgical guide in the opposing anatomical region. There does not appear to be support for the guide being placed anywhere other than the surgical area. Further, it does not make sense for the guide to placed anywhere other than the surgical area, as it is meant to guide the surgery; if the guide is elsewhere, how is it being used to guide the surgery?
See ([Par 45-46] “The surgical kit 150 further includes tissue punches 202 for removal of a known size of gingival tissue from beneath the openings in the surgical guide 110. The surgical kit 150 also includes starter drills 204, such as drill bits for creating a pilot hole and, possibly, countersinks for creating a certain shape to the opening of the osteotomy…. As mentioned previously, a surgical guide 110 was created through a technique that allows it to have a negative impression of the tissue surface within the patient's lower jaw bone. Accordingly, after it has been developed, the surgical guide 110 can be installed into the patient's mouth such that it fits snugly over the gingival tissue or teeth or bone. The surgical guide 110 is held in place in the patient's mouth by use of small, temporary fixations screws or pins 225 that fit through the openings 128 in the surgical guide 110. Once it is fixed in place, the surgical guide 110 is used to conduct surgery in accordance to the dental plan discussed above.”)
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The surgical guide is used to physically direct tools and therefore must be placed where the tools will actually be used, i.e. in the surgical region and not across from it.
Claim 52 recites “wherein determining that the surgical instrumentation data does not fit within the spatial constraints comprises determining, by the processor, that the at least one anatomical dimension exceeds a size threshold corresponding to the at least one corresponding dimension of the digital representation of the surgical instrumentation data”
There does not seem to be support for determining that the instrumentation does not fit in the mouth when the mouth is larger than the instrumentation. Further, it does not make logical sense for the condition for the instrumentation not fitting being that the dimensions of the mouth exceed the dimensions of the instrumentation. If the dimensions of the mouth are larger than the dimensions of the instrumentation, the instrumentation does fit, not the other way around. There is only support in the disclosure for the determination that the instrumentation does not fit being when the available anatomical dimensions are less than the dimensions of the instrumentation. (i.e. that the mouth dimensions must be larger than the tool for the tool to fit inside the mouth ([Par 11] “In response to the available dimensions being less than a dimension for the instrumentation to be used with each of the multiple dental implants, the method includes altering the surgical plan …” [Par 12 “Further, the method includes comparing the available dimensions to dimensions for the instrumentation, and altering at least one of (i) the instrumentation, (ii) the virtual surgical guide, (iii) the implant size, and/or (iv) the implant location in response to the dimensions for the instrumentation being greater than the available dimensions.”)
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25, 34, 40, and 52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 25, 34, and 40 recite the limitation “the entire arch” There is insufficient antecedent basis for this limitation in the claim. No arch was previously introduced.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “exceeds” in claim 52 is used by the claim to mean “is less than” while the accepted meaning is “is greater than.” The term is indefinite because the specification does not clearly redefine the term.
As mentioned in the relevant rejection of claim 52 under 112(a), claim 52 recites “wherein determining that the surgical instrumentation data does not fit within the spatial constraints comprises determining, by the processor, that the at least one anatomical dimension exceeds a size threshold corresponding to the at least one corresponding dimension of the digital representation of the surgical instrumentation data” i.e. that the instrumentation does not fit within the spatial constraints of the mouth if the dimensions of the mouth are sufficiently large to contain the instrumentation; it does not make logical sense for the condition for the instrumentation not fitting being that the dimensions of the mouth exceed the dimensions of the instrumentation. If the dimensions of the mouth are larger than the dimensions of the instrumentation, the instrumentation does fit, not the other way around. The use of the word “exceeds” therefore contradicts its plain meaning without an explanation of redefinition, as in with the accepted meaning of the term, if the size of the mouth exceeds the size of the instrumentation, the instrumentation will fit.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 34 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 34 depends on claim 33, which has been cancelled. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 40 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim recites “The non-transitory computer readable medium of claim 38 39.” This is improper dependent form. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 21-22, 25, 29-31, 34, and 38-53 are rejected under 35 U.S.C. 101 because they are directed to an abstract idea without significantly more.
Claim 21 (Statutory Category – Process)
Step 2A – Prong 1: Judicial Exception Recited?
Yes, the claim recites a mental process, specifically:
MPEP 2106.04(a)(2)(Ill): “Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, Judgments, and opinions.”
Further, the MPEP recites “The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation.”
generating a digital surgical plan including a virtual surgical guide for guiding placement of at least one candidate dental implant in a patient's open mouth, wherein generating the digital surgical plan comprises: …
Generating a surgical plan is a mental process equivalent to coming up with a plan for how a surgery should be performed, i.e. what steps, tools, techniques, etc. should be used. Such planning is commonly performed by doctors and surgeons. Further, coming up with a guide or template for use in the surgery is a mental process equivalent to observing the area in which surgery is to be performed, and creating such a template, for example by drawing it with a pencil and paper. For example, if a particular part of the roof of the mouth needs surgery, a surgeon might draw a diagram of the roof of the mouth to scale, and indicate on the diagram where incisions should be made. This kind of guide could later be used by physically overlaying it over the surgical area, allowing the surgeon to visually see where certain techniques should be used.
Doing this on a computer, i.e. using a “digital” surgical plan and a “virtual” surgical guide amounts to no more than mere instructions to apply the exception.
developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity using axial CT or CB scan data including scan data of a surgical region of the patient's upper or lower jaw to an opposing anatomical region of the patient's other jaw;
Developing such a model is a mental process equivalent to observing the scan data and using it to draw a representation of the patient’s mouth. For example, a person might draw a series of slices representing each scanned slice of the mouth.
The generation of a 3D virtual model amounts to no more than mere instructions to apply, as analyzed below.
Obtaining axial CT or CB scan data amounts to no more than mere data gathering, as analyzed below.
Should it be found that this is not a mental process, it is also an example of a well-understood, routine, conventional activity (WURC)
receiving, by a processor operably coupled to a memory device, and from the 3D virtual model, spatial constraint data of the patient's oral cavity, wherein the spatial constraint data represents spatial constraints imposed by anatomical structures of the patient's oral cavity and includes at least one anatomical dimension measured from the surgical region to the opposing anatomical region;
Determining the dimensions of the patient’s oral cavity is a mental process equivalent to observing the patient’s oral cavity and making judgments about its measurements, either visually or using a simple physical aide such as a ruler.
Doing this “by a processor operably coupled to a memory device” and using data from a “3D virtual model” of the patient’s mouth amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
positioning, by the processor and in the 3D virtual model, the virtual surgical guide in the opposing anatomical region of the 3D virtual model and aligned with a planned implant location for the at least one candidate dental implant;
Positioning the representation of the guide in a particular location of the model is a mental process equivalent to drawing the representation of the guide in that location on the drawn model, for example using a pencil and paper.
Doing this by a processor and using a “3D virtual model” of the patient’s mouth and a “virtual” guide amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, it is also an example of mere instructions to apply.
analyzing, by the processor, wherein analyzing the spatial data comprises: determining, by the processor, a height dimension in the 3D virtual model between a top of the virtual surgical guide and the opposing anatomical region; and comparing, by the processor, the height dimension to a corresponding dimension of a digital representation of surgical instrumentation data stored in the memory device, wherein the surgical instrumentation data represents at least one dimension of one or more candidate surgical instruments to be used in placing the at least one candidate dental implant in the patient's oral cavity; and determining by the processor and based on the analyzing, whether the surgical instrumentation data fits within the spatial constraints imposed by the anatomical structures or the virtual surgery guide, wherein determining whether the surgical instrumentation data fits within the spatial constraints comprises: computing, by the processor, a prediction of whether the one or more candidate surgical instruments will fit in the patient's oral cavity during execution of the digital surgical plan in a clinical setting with the patient's mouth open and including an actual surgical guide manufactured based on the virtual surgical guide;
Determining the dimensions of the model of the mouth and comparing those dimensions to that of the tool to determine if the tool fits is merely a mental process, but carried out using a general-purpose computer. For example, a person could mentally observe the tool, make judgments about its size either visually or using a ruler, observe the patient’s mouth and make judgments about its size, again either visually or using a ruler, and mentally compare the sizes to judge whether the tool is too big to fit in the mouth. This kind of basic size and shape comparison is a process human minds are particularly equipped to perform even at an early age, e.g. toys for infants and toddlers that involve multiple holes and pegs of different sizes and shapes and determining which fits where.
Doing this by a processor with data stored in memory and using a “3D virtual model” of the patient’s mouth, a “virtual” guide, and a digital representation of surgical instrumentation data amounts to no more than mere instructions to apply.
providing, by the processor and based on the prediction, human-readable information to one or more parties responsible for placement of the at least one candidate dental implant in the patient's open mouth, the human-readable information including: guidance about whether the digital surgical plan should be altered with a variation to one or more of the at least one candidate dental implant, the virtual surgical guide, and at least one surgical instrument selected for use from the one or more candidate surgical instruments prior to manufacture of the actual surgical guide and performance of the actual surgical plan for the patient.
Creating this guidance based on determining whether or not the tool fits is a mental process equivalent to judging if the surgical plan needs to be changed based on whether or not the tool fits, and if not, making alterations to the plan, for example by deciding that a different tool should be used. The guidance itself could be written down based on these decisions, as with a pencil and paper.
Doing this by a processor and using a “virtual” guide amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, this is also an example of insignificant post-solution activity.
Step 2A – Prong 2: Integrated into a Practical Solution?
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity using axial CT or CB scan data including scan data of a surgical region of the patient's upper or lower jaw to an opposing anatomical region of the patient's other jaw;
Obtaining a 3D model from a 3D scanning technique such as CT or CB scanning amounts to no more than mere data gathering.
Should it be found that this is not a mental process, it is also an example of a well-understood, routine, conventional activity (WURC)
receiving, by a processor operably coupled to a memory device, and from the 3D virtual model, spatial constraint data of the patient's oral cavity, wherein the spatial constraint data represents spatial constraints imposed by anatomical structures of the patient's oral cavity and includes at least one anatomical dimension measured from the surgical region to the opposing anatomical region; … determining, by the processor, a height dimension in the 3D virtual model between a top of the virtual surgical guide and the opposing anatomical region; and
Receiving and determining this data is equivalent to gathering generic measurement data in a generic manner, and therefore amounts to no more than mere data gathering.
Post-Solution Activity:
causing, by the processor, the 3D virtual model to be displayed on an electronic display device and in a human-readable format to one or more parties responsible for placement of the at least one candidate dental implant in the patient's open mouth;
This step merely presents the results of the mental process of generating the model, and therefore amounts to no more than insignificant post-solution activity.
providing, by the processor and based on the prediction, human-readable information to one or more parties responsible for placement of the at least one candidate dental implant in the patient's open mouth, the human-readable information including: guidance about whether the digital surgical plan should be altered with a variation to one or more of the at least one candidate dental implant, the virtual surgical guide, and at least one surgical instrument selected for use from the one or more candidate surgical instruments prior to manufacture of the actual surgical guide and performance of the actual surgical plan for the patient.
This step merely presents the results of the mental process of determining whether or not the tool fits, and therefore amounts to no more than insignificant post-solution activity.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity
Applying a computer to create a generic 3D model at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that model creation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the model is “developed” without reciting how this development is actually accomplished.
positioning, by the processor and in the 3D virtual model, the virtual surgical guide in the opposing anatomical region of the 3D virtual model and aligned with a planned implant location for the at least one candidate dental implant;
Applying a computer to position a virtual object at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that positioning, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the guide is placed opposing and aligned with the planned implant location without reciting how this virtual positioning is actually accomplished.
Moreover, Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “A computer-implemented method, comprising: … a digital surgical plan including a virtual surgical guide; the processor; a three-dimensional (3D) virtual model of the patient's oral cavity; an electronic display device, a processor operably coupled to a memory device; a digital representation of surgical instrumentation data stored in memory;” are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
Step 2B: Claim provides an Inventive Concept?
No, as discussed with respect to Step 2A, the additional limitations are insignificant extra solution activity, mere instructions to apply, and WURC and do not impose any meaningful limits on practicing the abstract idea and therefore the claim does not provide an inventive concept in Step 2B.
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity using axial CT or CB scan data including scan data of a surgical region of the patient's upper or lower jaw to an opposing anatomical region of the patient's other jaw;
Obtaining a 3D model from a 3D scanning technique such as CT or CB scanning amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Should it be found that this is not a mental process, it is also an example of a well-understood, routine, conventional activity (WURC)
receiving, by a processor operably coupled to a memory device, and from the 3D virtual model, spatial constraint data of the patient's oral cavity, wherein the spatial constraint data represents spatial constraints imposed by anatomical structures of the patient's oral cavity and includes at least one anatomical dimension measured from the surgical region to the opposing anatomical region; … determining, by the processor, a height dimension in the 3D virtual model between a top of the virtual surgical guide and the opposing anatomical region; and
Receiving and determining this data is equivalent to gathering generic measurement data in a generic manner, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Post-Solution Activity:
causing, by the processor, the 3D virtual model to be displayed on an electronic display device and in a human-readable format to one or more parties responsible for placement of the at least one candidate dental implant in the patient's open mouth;
This step merely presents the results of the mental process of generating the model, and therefore amounts to no more than insignificant post-solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
providing, by the processor and based on the prediction, human-readable information to one or more parties responsible for placement of the at least one candidate dental implant in the patient's open mouth, the human-readable information including: guidance about whether the digital surgical plan should be altered with a variation to one or more of the at least one candidate dental implant, the virtual surgical guide, and at least one surgical instrument selected for use from the one or more candidate surgical instruments prior to manufacture of the actual surgical guide and performance of the actual surgical plan for the patient.
This step merely presents the results of the mental process of determining whether or not the tool fits, and therefore amounts to no more than insignificant post-solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity
Applying a computer to create a generic 3D model at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that model creation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the model is “developed” without reciting how this development is actually accomplished.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
positioning, by the processor and in the 3D virtual model, the virtual surgical guide in the opposing anatomical region of the 3D virtual model and aligned with a planned implant location for the at least one candidate dental implant;
Applying a computer to position a virtual object at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that positioning, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the guide is placed opposing and aligned with the planned implant location without reciting how this virtual positioning is actually accomplished.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
Moreover, Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “A computer-implemented method, comprising: … a digital surgical plan including a virtual surgical guide; the processor; a three-dimensional (3D) virtual model of the patient's oral cavity; an electronic display device, a processor operably coupled to a memory device; a digital representation of surgical instrumentation data stored in memory;” are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
Well-Understood, Routine, Conventional Activity (WURC) has found that claim elements that are understood to be Well-Understood, Routine, Conventional Activity are not indicative of Integration into a Practical Solution nor evidence of an Inventive Concept (MPEP 2106.05(d))
WURC:
developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity using axial CT or CB scan data
Quantitative Evaluation of the Accuracy of Micro-Computed Tomography in Tooth Measurement ([Page 2 Col 1 Par 2- Col 2 Par 1])
Three-dimensional analysis of mandibular growth and tooth eruption ([Page 671 Col 1 Par 1])
Dental CT Imaging as a Screening Tool for Dental Profiling: Advantages and Limitations ([Page 115 Col 1 Par 1])
Personal Computer-Based Three-Dimensional Computed Tomographic Images of the Teeth for Evaluating Supernumerary or Ectopically Impacted Teeth ([Figure 2, Figure 8])
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 22 recites “further comprising calculating, by the processor, the spatial constraint data using the 3D virtual model.”
Determining this spatial constraint data is a mental process equivalent to observing the patient’s mouth and judging the dimensions of it, either purely visually or by using a simple physical aide such as a ruler.
The use of a processor and using data from a “3D virtual model” of the patient’s mouth amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
Determining this data is equivalent to gathering generic measurement data in a generic manner, and therefore amounts to no more than mere data gathering.
Claim 25 recites “further comprising reconstructing, by the processor, the axial CT or CB scan data with a 512x512 matrix and a field of view that includes the entire arch of the patient's oral cavity”
This merely clarifies how the scan data is acquired, and is therefore merely an extension of the mental process and mere data gathering steps.
Further note that performing axial CT or CB scans of a patient’s teeth/skull is an example of Well-Understood, Routine, Conventional Activity. See below:
Quantitative Evaluation of the Accuracy of Micro-Computed Tomography in Tooth Measurement ([Page 2 Col 1 Par 2- Col 2 Par 1])
Three-dimensional analysis of mandibular growth and tooth eruption ([Page 671 Col 1 Par 1])
Dental CT Imaging as a Screening Tool for Dental Profiling: Advantages and Limitations ([Page 115 Col 1 Par 1])
Personal Computer-Based Three-Dimensional Computed Tomographic Images of the Teeth for Evaluating Supernumerary or Ectopically Impacted Teeth ([Figure 2, Figure 8])
Claim 29 recites “further comprising positioning, by the processor and in the 3D virtual model, a virtual representation of the at least one candidate dental implant in the 3D virtual model.”
Positioning the representation of the implant in a particular location of the model is a mental process equivalent to drawing the representation of the implant in that location on the drawn model, for example using a pencil and paper.
Doing this by a processor and using a “3D virtual model” of the patient’s mouth and a “virtual” representation of the implant amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, it is also an example of mere instructions to apply.
Applying a computer to position a virtual object at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that positioning, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the representation of the implant is placed in the model without reciting how this virtual positioning is actually accomplished.
Claim 30 The elements of claim 30 are substantially the same as those of claim 21. Therefore, the elements of claim 30 are rejected due to the same reasons as outlined above for claim 21.
Moreover, Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “A system, comprising: at least one processor and a non-transitory computer-readable storage device operably coupled to the at least one processor and comprising instructions that, when executed by the at least one processor, configure the at least one processor to perform operations to generate a digital surgical plan including a virtual surgical guide; a three-dimensional (3D) virtual mode; an electronic display device; a surgical instrumentation model stored in the storage device” are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 31 recites “wherein when executed by the at least one processor, the instructions configure the at least one processor to perform operations to calculate the spatial constraint data using the 3D virtual model.”
Determining this spatial constraint data is a mental process equivalent to observing the patient’s mouth and judging the dimensions of it, either purely visually or by using a simple physical aide such as a ruler.
The use of a processor and using data from a “3D virtual model” of the patient’s mouth amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
Determining this data is equivalent to gathering generic measurement data in a generic manner, and therefore amounts to no more than mere data gathering.
Claim 34 recites “wherein the surgical region from which the at least one anatomical dimension is measured corresponds to a top surface of the virtual surgical guide aligned with the planned implant location for the at least one candidate dental implant wherein when executed by the at least one processor, the instructions configure the at least one processor to reconstruct the axial CT or CB scan
data with a 512x512 matrix and a field of view that includes the entire arch of the patient's oral cavity.
This merely clarifies how the measurements are made and is therefore merely an extension of the mental process and data gathering steps.
Further, reconstructing a 3D model from an axial CT or CB scan is an example of a well-understood, routine, conventional activity. See below:
Quantitative Evaluation of the Accuracy of Micro-Computed Tomography in Tooth Measurement ([Page 2 Col 1 Par 2- Col 2 Par 1])
Three-dimensional analysis of mandibular growth and tooth eruption ([Page 671 Col 1 Par 1])
Dental CT Imaging as a Screening Tool for Dental Profiling: Advantages and Limitations ([Page 115 Col 1 Par 1])
Personal Computer-Based Three-Dimensional Computed Tomographic Images of the Teeth for Evaluating Supernumerary or Ectopically Impacted Teeth ([Figure 2, Figure 8])
Claim 38 (Statutory Category – Machine)
Step 2A – Prong 1: Judicial Exception Recited?
Yes, the claim recites a mental process, specifically:
MPEP 2106.04(a)(2)(Ill): “Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, Judgments, and opinions.”
Further, the MPEP recites “The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation.”
generating a digital surgical plan including a virtual surgical guide for guiding placement of at least one candidate dental implant in a patient's open mouth, wherein for generating the digital surgical plan, the instructions further cause the at least one processor to perform operations comprising:
Generating a surgical plan is a mental process equivalent to coming up with a plan for how a surgery should be performed, i.e. what steps, tools, techniques, etc. should be used. Such planning is commonly performed by doctors and surgeons since the invention of surgical practices. Further, coming up with a guide or template for use in the surgery is a mental process equivalent to observing the area in which surgery is to be performed, and creating such a template, for example by drawing it with a pencil and paper. For example, if a particular part of the roof of the mouth needs surgery, a surgeon might draw a diagram of the roof of the mouth to scale, and indicate on the diagram where incisions should be made. This kind of guide could later be used by physically overlaying it over the surgical area, allowing the surgeon to visually see where certain techniques should be used.
Doing this on a computer, i.e. using a “digital” surgical plan and a “virtual” surgical guide amounts to no more than mere instructions to apply the exception.
developing a three-dimensional (3D) virtual model of the patient's oral cavity using axial CT or CB scan data including scan data of a surgical region of the patient's upper or lower jaw to a region of the patient's opposing jaw;
Developing such a model is a mental process equivalent to observing the scan data and using it to draw a representation of the patient’s mouth. For example, a person might draw a series of slices representing each scanned slice of the mouth.
The generation of a 3D virtual model amounts to no more than mere instructions to apply, as analyzed below.
Obtaining axial CT or CB scan data amounts to no more than mere data gathering, as analyzed below.
Should it be found that this is not a mental process, it is also an example of a well-understood, routine, conventional activity (WURC)
receiving, from the 3D virtual model, spatial constraint data of the patient's oral cavity wherein the spatial constraint data represents spatial constraints imposed by anatomical structures of the patient's oral cavity and includes at least one dimension measured from the surgical region to the region of the patient's opposing jaw;
Determining the dimensions of the patient’s oral cavity is a mental process equivalent to observing the patient’s oral cavity and making judgments about its measurements, either visually or using a simple physical aide such as a ruler.
Doing this “by a processor operably coupled to a memory device” and using data from a “3D virtual model” of the patient’s mouth amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
causing the virtual surgical guide to be positioned in the opposing anatomical region of the 3D virtual model and aligned with a planned implant location for the at least one candidate dental implant;
Positioning the representation of the guide in a particular location of the model is a mental process equivalent to drawing the representation of the guide in that location on the drawn model, for example using a pencil and paper.
Doing this by a processor and using a “3D virtual model” of the patient’s mouth and a “virtual” guide amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, it is also an example of mere instructions to apply.
analyzing the spatial constraint data, when executed by at least one processor, the instructions cause the at least one processor to perform operations further comprising: determining a height dimension in the 3D virtual model between a top of the virtual surgical guide and the region of the patient's opposing jaw; and comparing the height dimension to a corresponding dimension of a digital model of surgical instrumentation data accessible to the at least one processor, wherein the surgical instrumentation data represents at least one dimension of one or more candidate surgical instruments to be used in placing the at least one candidate dental implant in the patient's oral cavity; determining, based on the comparing, whether the digital model of the one or more surgical instruments fits within the spatial constraints imposed by the anatomical structures of the patient's oral cavity, wherein for determining whether the digital model of the one or more surgical instruments fits within the spatial constraints, the instructions further cause the at least one processor to perform operations comprising: computing a prediction of whether the one or more candidate surgical instruments will fit in the patient's oral cavity during execution of the digital surgical plan in a clinical setting with the patient's mouth open and including an actual surgical guide manufactured based on the virtual surgical guide;
Determining the dimensions of the model of the mouth and comparing those dimensions to that of the tool to determine if the tool fits is merely a mental process, but carried out using a general-purpose computer. For example, a person could mentally observe the tool, make judgments about its size either visually or using a ruler, observe the patient’s mouth and make judgments about its size, again either visually or using a ruler, and mentally compare the sizes to judge whether the tool is too big to fit in the mouth. This kind of basic size and shape comparison is a process human minds are particularly equipped to perform even at an early age, e.g. toys for infants and toddlers that involve multiple holes and pegs of different sizes and shapes and determining which fits where.
Doing this by a processor with data stored in memory and using a “3D virtual model” of the patient’s mouth, a “virtual” guide, and a digital representation of surgical instrumentation data amounts to no more than mere instructions to apply.
providing, based on the prediction, human-readable information to one or more parties responsible for placement of at least one candidate dental implant in the patient's open mouth, the human-readable information including: guidance about whether the digital surgical plan should be altered with a variation to one or more of the at least one candidate dental implant, the virtual surgical guide, and at least one surgical instrument selected for use from the one or more candidate surgical instruments prior to manufacture of the actual surgical guide and performance of the actual surgical plan for the patient;
Creating this guidance based on determining whether or not the tool fits is a mental process equivalent to judging if the surgical plan needs to be changed based on whether or not the tool fits, and if not, making alterations to the plan, for example by deciding that a different tool should be used. The guidance itself could be written down based on these decisions, as with a pencil and paper.
Doing this by a processor and using a “virtual” guide amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, this is also an example of insignificant post-solution activity.
performing one of the following operations: (i) in response to it being determined that the digital model of the digital model of the one or more surgical instruments fits within the spatial constraints, causing the digital surgical plan to be finalized into an as-finalized form that includes at least the one or more candidate surgical instruments;
Finalizing the plan after determining that the tool fits is a mental process equivalent to judging that the current version of the surgical plan is the plan that will be used and that no further modifications should be made. Details of the plan can then be recorded, for example by writing them down with a pencil and paper.
Doing this by a processor and using a “digital” model and surgical plan amounts to no more than mere instructions to apply.
(ii) in response to it being determined that the digital model of the digital model of the one or more surgical instruments does not fit within the spatial constraints,(a) modifying the digital surgical plan, wherein for modifying the digital surgical plan, the instructions cause the at least one processor to perform operations further comprising: implementing a change to at least one of: the one or more candidate surgical instruments, the at least one candidate dental implant, the virtual surgical guide, and at least one parameter for placement of the at least one candidate dental implant; and iterating through at least: the comparing and the computing operations until it is predicted that the one or more candidate surgical instruments will fit in the patient's oral cavity during the execution of the digital surgical plan in the clinical setting; and(b) causing an as-modified digital surgical plan to be finalized into an as- finalized form when it is determined that the digital model of the one or more surgical instruments will fit within the spatial constraints.
Performing this iterative modification is a mental process equivalent to modifying parts of the plan until it is determined that the physical components used in the surgery fit. For example, after determining that the currently chosen tool does not fit in the patient’s mouth, a surgeon my keep selecting new tools, measuring them, and determining if they will fit in the patient’s mouth until one that does fit is found. Once this is found, “finalizing” the plan is equivalent to merely to judging that the current version of the surgical plan is the plan that will be used and that no further modifications should be made. Details of the plan can then be recorded, for example by writing them down with a pencil and paper.
Doing this by a processor and using a “digital” model and surgical plan amounts to no more than mere instructions to apply.
Step 2A – Prong 2: Integrated into a Practical Solution?
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
developing a three-dimensional (3D) virtual model of the patient's oral cavity using axial CT or CB scan data including scan data of a surgical region of the patient's upper or lower jaw to a region of the patient's opposing jaw;
Obtaining a 3D model from a 3D scanning technique such as CT or CB scanning amounts to no more than mere data gathering.
Should it be found that this is not a mental process, it is also an example of a well-understood, routine, conventional activity (WURC)
receiving, from the 3D virtual model, spatial constraint data of the patient's oral cavity wherein the spatial constraint data represents spatial constraints imposed by anatomical structures of the patient's oral cavity and includes at least one dimension measured from the surgical region to the region of the patient's opposing jaw; … determining a height dimension in the 3D virtual model between a top of the virtual surgical guide and the region of the patient's opposing jaw;
Receiving and determining this data is equivalent to gathering generic measurement data in a generic manner, and therefore amounts to no more than mere data gathering.
Post-solution activity:
causing, by the processor, the 3D virtual model to be displayed on an electronic display device and in a human-readable format to one or more parties responsible for placement of the at least one candidate dental implant in the patient's open mouth;
This step merely presents the results of the mental process of generating the model, and therefore amounts to no more than insignificant post-solution activity.
providing, based on the prediction, human-readable information to one or more parties responsible for placement of at least one candidate dental implant in the patient's open mouth, the human-readable information including: guidance about whether the digital surgical plan should be altered with a variation to one or more of the at least one candidate dental implant, the virtual surgical guide, and at least one surgical instrument selected for use from the one or more candidate surgical instruments prior to manufacture of the actual surgical guide and performance of the actual surgical plan for the patient;
This step merely presents the results of the mental process of determining whether or not the tool fits, and therefore amounts to no more than insignificant post-solution activity.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
developing a three-dimensional (3D) virtual model of the patient's oral cavity
Applying a computer to create a generic 3D model at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that model creation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the model is “developed” without reciting how this development is actually accomplished.
causing the virtual surgical guide to be positioned in the opposing anatomical region of the 3D virtual model and aligned with a planned implant location for the at least one candidate dental implant;
Applying a computer to position a virtual object at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that positioning, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the guide is placed opposing and aligned with the planned implant location without reciting how this virtual positioning is actually accomplished.
Moreover, Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “A non-transitory computer readable medium comprising instructions that, when executed by at least one processor, cause the at least one processor to perform operations comprising … a digital surgical plan including a virtual surgical guide; a 3D virtual model; an electronic display device; a digital model of surgical instrumentation “ are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
Step 2B: Claim provides an Inventive Concept?
No, as discussed with respect to Step 2A, the additional limitations are insignificant extra solution activity, mere instructions to apply, and WURC and do not impose any meaningful limits on practicing the abstract idea and therefore the claim does not provide an inventive concept in Step 2B.
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
developing a three-dimensional (3D) virtual model of the patient's oral cavity using axial CT or CB scan data including scan data of a surgical region of the patient's upper or lower jaw to a region of the patient's opposing jaw;
Obtaining a 3D model from a 3D scanning technique such as CT or CB scanning amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Should it be found that this is not a mental process, it is also an example of a well-understood, routine, conventional activity (WURC)
receiving, from the 3D virtual model, spatial constraint data of the patient's oral cavity wherein the spatial constraint data represents spatial constraints imposed by anatomical structures of the patient's oral cavity and includes at least one dimension measured from the surgical region to the region of the patient's opposing jaw; … determining a height dimension in the 3D virtual model between a top of the virtual surgical guide and the region of the patient's opposing jaw;
Receiving and determining this data is equivalent to gathering generic measurement data in a generic manner, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Post-solution activity:
causing, by the processor, the 3D virtual model to be displayed on an electronic display device and in a human-readable format to one or more parties responsible for placement of the at least one candidate dental implant in the patient's open mouth;
This step merely presents the results of the mental process of generating the model, and therefore amounts to no more than insignificant post-solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
providing, based on the prediction, human-readable information to one or more parties responsible for placement of at least one candidate dental implant in the patient's open mouth, the human-readable information including: guidance about whether the digital surgical plan should be altered with a variation to one or more of the at least one candidate dental implant, the virtual surgical guide, and at least one surgical instrument selected for use from the one or more candidate surgical instruments prior to manufacture of the actual surgical guide and performance of the actual surgical plan for the patient;
This step merely presents the results of the mental process of determining whether or not the tool fits, and therefore amounts to no more than insignificant post-solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
developing a three-dimensional (3D) virtual model of the patient's oral cavity
Applying a computer to create a generic 3D model at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that model creation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the model is “developed” without reciting how this development is actually accomplished.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
causing the virtual surgical guide to be positioned in the opposing anatomical region of the 3D virtual model and aligned with a planned implant location for the at least one candidate dental implant;
Applying a computer to position a virtual object at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that positioning, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the guide is placed opposing and aligned with the planned implant location without reciting how this virtual positioning is actually accomplished.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
Moreover, Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. In light of this, the additional generic computer component elements of “A non-transitory computer readable medium comprising instructions that, when executed by at least one processor, cause the at least one processor to perform operations comprising … a digital surgical plan including a virtual surgical guide; a 3D virtual model; an electronic display device; a digital model of surgical instrumentation “ are not sufficient to integrate a judicial exception into a practical application nor provide evidence of an inventive concept.
Well-Understood, Routine, Conventional Activity (WURC) has found that claim elements that are understood to be Well-Understood, Routine, Conventional Activity are not indicative of Integration into a Practical Solution nor evidence of an Inventive Concept (MPEP 2106.05(d))
WURC:
developing a three-dimensional (3D) virtual model of the patient's oral cavity using axial CT or CB scan data including scan data of a surgical region of the patient's upper or lower jaw to a region of the patient's opposing jaw;
Quantitative Evaluation of the Accuracy of Micro-Computed Tomography in Tooth Measurement ([Page 2 Col 1 Par 2- Col 2 Par 1])
Three-dimensional analysis of mandibular growth and tooth eruption ([Page 671 Col 1 Par 1])
Dental CT Imaging as a Screening Tool for Dental Profiling: Advantages and Limitations ([Page 115 Col 1 Par 1])
Personal Computer-Based Three-Dimensional Computed Tomographic Images of the Teeth for Evaluating Supernumerary or Ectopically Impacted Teeth ([Figure 2, Figure 8])
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 39 recites “wherein, when executed by the at least one processor, the instructions cause the at least one processor to calculate the spatial constraint data using the 3D virtual model.”
Determining this spatial constraint data is a mental process equivalent to observing the patient’s mouth and judging the dimensions of it, either purely visually or by using a simple physical aide such as a ruler.
The use of a processor and using data from a “3D virtual model” of the patient’s mouth amounts to no more than mere instructions to apply.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
Determining this data is equivalent to gathering generic measurement data in a generic manner, and therefore amounts to no more than mere data gathering.
Claim 40 recites “wherein, when executed by the at least one processor, the instructions cause the at least one processor to reconstruct the axial CT or CB scan data with a 512x512 matrix and a field of view that includes the entire arch of the patient's oral cavity”
This merely clarifies how the scan data is acquired, and is therefore merely an extension of the mental process and mere data gathering steps.
Further note that performing an axial CT or CB scan of a patient’s teeth/skull is an example of a well-understood, routine, conventional activity (WURC). See below:
Quantitative Evaluation of the Accuracy of Micro-Computed Tomography in Tooth Measurement ([Page 2 Col 1 Par 2- Col 2 Par 1])
Three-dimensional analysis of mandibular growth and tooth eruption ([Page 671 Col 1 Par 1])
Dental CT Imaging as a Screening Tool for Dental Profiling: Advantages and Limitations ([Page 115 Col 1 Par 1])
Personal Computer-Based Three-Dimensional Computed Tomographic Images of the Teeth for Evaluating Supernumerary or Ectopically Impacted Teeth ([Figure 2, Figure 8])
Claim 41 recites “further comprising performing an axial CT or CB scan of the patient's oral cavity to obtain the axial CT or CB scan data for use in developing the 3D virtual model.”
This merely clarifies how the scan data is acquired, and is therefore merely an extension of the mental process and mere data gathering steps.
Claim 42 recites “wherein the one or more candidate surgical instruments comprises one or more of tissue punches, drill bits, counter sinks, dental implants, implant mounts, or any combination thereof.”
This merely clarifies the form of the surgical instruments, and therefore is merely an extension of the mental process and mere instructions to apply.
Claim 43 recites “wherein generating a digital surgical plan comprises specifying a location, orientation, and depth for placing the at least one candidate dental implant in the patient's oral cavity.”
As stated earlier, developing a surgical plan is a mental process that is equivalent to writing out a details on how to carry out a particular surgery, as with pencil and paper. Specifying a location, orientation, and depth for the implant is merely the act of adding such information to the written plan.
Doing this by a processor and using a “digital” surgical plan amounts to no more than mere instructions to apply.
Claim 44 recites “further comprising generating, by the processor, the virtual surgical guide using the digital surgical plan and the 3D virtual model.”
Coming up with a guide or template for use in the surgery using the model and current plan is a mental process equivalent to observing the model of the area in which surgery is to be performed, and creating such a template, for example by drawing it with a pencil and paper. For example, if a particular part of the roof of the mouth needs surgery, a surgeon might draw a diagram of the roof of the mouth to scale, and indicate on the diagram where incisions should be made, and with which tools from the current plan. This kind of guide could later be used by physically overlaying it over the surgical area, allowing the surgeon to visually see where certain techniques should be used.
Doing this on a computer, i.e. using a “digital” surgical plan, a “virtual” surgical guide, and a 3D virtual model amounts to no more than mere instructions to apply the exception.
Claim 45 recites “further comprising causing, by the processor, data representative of the virtual model to be transmitted to a manufacturer for manufacturing the actual surgical guide according to the data representative of the virtual model.”
Giving the model data to the manufacturer after the mental process of creating the model is equivalent to merely presenting the results of the mental process, and therefore amounts to no more than insignificant post-solution activity.
It should be further noted that transmitting data in such a manner is also explicitly recognized by the courts as an example of WURC (MPEP 2106.05(d)(II)(i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));)
Claim 46 recites “further comprising manufacturing the actual surgical guide based on the virtual surgical guide.”
Manufacturing the guide after the mental steps of designing it amounts to no more than acting on the results of the abstract idea, and therefore is an example of insignificant post solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Claim 47 recites “further comprising causing, by the processor, the digital surgical to be output in a human-readable format.”
This element merely consists of presenting the results of the mental process, and therefore amounts to no more than insignificant post-solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Claim 48 recites “further comprising: in response to determining that the surgical instrumentation data fits within the spatial constraints, causing, by the processor, the digital surgical plan to be finalized into an as-finalized form that includes at least the one or more candidate surgical instruments.”
Finalizing the plan after determining that the tool fits is a mental process equivalent to judging that the current version of the surgical plan is the plan that will be used and that no further modifications should be made. Details of the plan can then be recorded, for example by writing them down with a pencil and paper.
Doing this by a processor and using a “digital” model and surgical plan amounts to no more than mere instructions to apply.
Claim 49 recites “wherein the digital surgical plan in the as- finalized form further includes the one or more candidate dental implants. “
This merely clarifies what information is included in the finalized plan and is therefore merely an extension of the mental process and mere instructions to apply.
Claim 50 recites “further in response to determining that the surgical instrumentation data fits within the spatial constraints, causing, by the processor, the digital surgical plan in the as-finalized form to be output in a human-readable format.”
Outputting this information is merely the act of presenting the results of the mental process, and therefore amounts to no more than insignificant post-solution activity.
This element merely acts on the results of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Claim 51 recites “in response to determining that the surgical instrumentation data does not fit within the spatial constraints,(i) modifying, by the processor, the digital surgical plan, wherein modifying the digital surgical plan comprises:(a) implementing, by the processor, a change to at least one of: the one or more candidate surgical instruments, the at least one candidate dental implant, the virtual surgical guide, and at least one parameter for placement of the at least one candidate dental implant; and(b) iterating, by the processor, through at least the comparing and the determining steps of the method until it is predicted that the one or more candidate surgical instruments will fit in the patient's oral cavity during the execution of the digital surgical plan in the clinical setting and with the actual surgical guide; and(ii) finalizing, by the processor, an as-modified digital surgical plan when it is determined that the surgical instrumentation data will fit within the spatial constraints.”
Performing this iterative modification is a mental process equivalent to modifying parts of the plan until it is determined that the physical components used in the surgery fit. For example, after determining that the currently chosen tool does not fit in the patient’s mouth, a surgeon my keep selecting new tools, measuring them, and determining if they will fit in the patient’s mouth until one that does fit is found. Once this is found, “finalizing” the plan is equivalent to merely to judging that the current version of the surgical plan is the plan that will be used and that no further modifications should be made. Details of the plan can then be recorded, for example by writing them down with a pencil and paper.
Doing this by a processor and using a “digital” model and surgical plan amounts to no more than mere instructions to apply.
Claim 52 recites “wherein determining that the surgical instrumentation data does not fit within the spatial constraints comprises determining, by the processor, that the at least one anatomical dimension exceeds a size threshold corresponding to the at least one corresponding dimension of the digital representation of the surgical instrumentation data.”
Determining if the dimensions of one thing are bigger than the dimensions of another thing is a mental process equivalent to observing both things, judging their size either purely visually or using a simple aide such as a ruler, and based on these measurements determining which is larger.
Claim 53 recites “wherein modifying the digital surgical plan includes one or more of. selecting at least one alternative dental implant to replace the at least one candidate dental implant for use in the digital surgical plan;
Selecting an alternative implant is a mental process equivalent to judging that another implant should be used. This change can then be reflected on a written plan by adding the new information and removing the old, as with a pencil and paper.
Doing this by a processor and using a “digital” surgical plan amounts to no more than mere instructions to apply.
adjusting placement coordinates of the at least one candidate dental implant in the digital surgical plan;
Adjusting the placement coordinates is a mental process equivalent to judging that the placement coordinates should be different from originally written. This change can then be reflected on a written plan by adding the new information and removing the old, as with a pencil and paper.
Doing this by a processor and using a “digital” surgical plan amounts to no more than mere instructions to apply.
adjusting placement angles of the at least one candidate dental implant in the digital surgical plan;
Adjusting the placement angles is a mental process equivalent to judging that the placement angles should be different from originally written. This change can then be reflected on a written plan by adding the new information and removing the old, as with a pencil and paper.
Doing this by a processor and using a “digital” surgical plan amounts to no more than mere instructions to apply.
selecting at least one alternative surgical instrument to replace at least one of the one or more candidate surgical instruments for use in the digital surgical plan; and
Selecting an alternative instrument is a mental process equivalent to judging that another instrument should be used. This change can then be reflected on a written plan by adding the new information and removing the old, as with a pencil and paper.
Doing this by a processor and using a “digital” surgical plan amounts to no more than mere instructions to apply.
altering one or more dimensions of the virtual surgical guide for use in the digital surgical plan.
Altering the design of the guide is a mental process equivalent to drawing a new representation of the guide with different dimensions, for example by drawing with a pencil and paper.
Doing this by a processor and using a “digital” surgical plan and “virtual” guide amounts to no more than mere instructions to apply.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-22, 25, 29-31, 34, and 41-47 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schmitt (US 20080085489 A1) in view of Fenick (US 5015183 A) in further view of Boerjes (WO 2007084727 A1) as well as Suryanarayanan (JP 2005199041 A)
Claim 21. Schmitt teaches A computer-implemented method comprising: ([Abstract] “A method is set forth for making a computer model of patient's jaws on the basis of digital information.”) generating a digital surgical plan ([Par 5] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) including a virtual surgical guide for guiding placement of at least one candidate dental implant in a patient's ([Par 6] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” [Par 59] “FIG. 8C shows the virtual upper cast 45 virtual lower cast 44 and occlusal index 56 with the jaw opened the same amount as in FIG. 8B” [Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants, and manufacturing an actual drill guide based on data of the virtual drill guide.”) developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity ([Par 11] “In some embodiments, the exemplary methods and systems disclosed herein create a virtual computer model of a patient's mouth and to ideally position virtual artificial teeth in proper spatial orientation to the supporting tissues, teeth and the opposing arch.” [Par 85] “In some aspects, generating a virtual model includes scanning a portion of a patient's jaw to obtain scan data; and generating a 3-D image of the portion of the patient's jaw”) using ([Par 44] “FIG. 4 illustrates the CT bite plate assembly 10 placed in a patient's mouth and the patient positioned in a CT machine 46. An x-ray source 48 projects radiation across the patient's head and is detected on a sensor 50. As disclosed further below, using the data obtained from this CT scan, an image of the patient's jaws and teeth may be generated.”) causing, by the processor, the 3D virtual model to be displayed on an electronic display device and in a human-readable format to one or more parties responsible for placement of the at least one candidate dental implant in the patient's ([Par 55] “FIG. 7A illustrates one example of a virtual model of a virtual lower jaw 35 and virtual teeth 36 from CT data as it may appear on a computer display. The teeth 36 and roots may have a different radiographic density than the bone of the lower jaw 35, allowing a user operator to identify them by their gray-scale value relative to the gray-scale value of the lower jaw.” [Par 83] “Using the Internet, data may be sent from the processing unit 502 to the remote computer 520 or the manufacturing site 522. In one example, the remote computer may be a dentist's or other provider's computer”) receiving, by a processor operably coupled to a memory device, ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) and from the 3D virtual model, spatial constraint data of the patient's oral cavity, wherein the spatial constraint data represents spatial constraints imposed by anatomical structures of the patient's oral cavity and includes at least one anatomical dimension measured from the surgical region to the opposing anatomical region; ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…” [Par 44] “An x-ray source 48 projects radiation across the patient's head and is detected on a sensor 50. As disclosed further below, using the data obtained from this CT scan, an image of the patient's jaws and teeth may be generated.” [Par 51] “At step 618, the 3D file of the lower dental cast is joined to the 3D file of the mandible of the patient for unified movement in computer space. At step 620, virtual movement of the lower jaw relative to the upper jaw may be created using data from a digital recorder, static records, or average measurement. This data may have been obtained, such as when using the digital recorder, by scanning the patient's jaws while he or she moves the upper and lower jaws relative to each other, thereby tracking the pathway of relative movement. These recorders may include ultrasound, infrared, light and other methods of recording the positional relationships.”) positioning, by the processor and in the 3D virtual model, the virtual surgical guide in ([Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants…” [Par 65-66] “FIG. 9 illustrates the virtual model of the lower cast 44 with the cast reshaped (as indicated by the reference numeral 47) to provide space for the restoration and to have the proper contour for the dental implants 42. Areas of contact for the occlusal index 56 are indicated by the stars identified by the reference numeral 43. In addition, FIG. 9 shows that some of the images of the original patient's teeth have been re-added or have not been virtually removed. These virtual teeth may be used as reference points for creating the first virtual drill guide and may provide a stable base for the actual first drill guide after it is formed. FIG. 9 also shows virtual dental implants 42 placed in the lower jaw in areas that have adequate volume of bone after the teeth are extracted. … The lower cast is positioned in the same computer space as the virtual model of the lower jaw 35 with dental implants 42. …. In the example of FIG. 9 contact areas 43 on the surface of three teeth have been retained to allow for proper indexing of the drill guide. Since the lower cast and the CT data about the lower jaw are oriented in computer space using the CT bite plate of FIG. 3, it is possible to create a drill guide that has contact on the teeth for proper orientation, a shape that determines the correct form of the bone 47, and that also has cylinders in it to determine the correct angulation and vertical position of the dental implants 42. One exemplary method for creating the virtual guide includes using an extrusion operation to create a mass formed to precisely interface with the virtual jaw and with the remaining virtual teeth of the virtual model.”) analyzing, by the processor, wherein analyzing the spatial data comprises: determining, by the processor, a height dimension in the 3D virtual model ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…” [Par 51] “At step 618, the 3D file of the lower dental cast is joined to the 3D file of the mandible of the patient for unified movement in computer space. At step 620, virtual movement of the lower jaw relative to the upper jaw may be created using data from a digital recorder, static records, or average measurement. This data may have been obtained, such as when using the digital recorder, by scanning the patient's jaws while he or she moves the upper and lower jaws relative to each other, thereby tracking the pathway of relative movement. These recorders may include ultrasound, infrared, light and other methods of recording the positional relationships.” [Examiner’s note: the “positional relationship of the dental implants in relation to the opposing arch” would include the height measurement]) ([Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants…”) and the opposing anatomical region; ([Par 16] “…to record the positional relationship of the dental implants in relation to the opposing arch…”)and ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) the height dimension ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…”) ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) ([Par 5] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” [Par 21] “The method may include inserting at least one first dental implant in a patient's mouth;” ) and determining, by the processor ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”)and based on the analyzing, ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…”) ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…” or the virtual surgery guide, ([Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants…”) ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) in a clinical setting with the patient's mouth ([Par 67] “Once the virtual drill guide's form and shape are determined, an actual drill guide may be manufactured by, for example, rapid prototyping or cutting with a five axis mill.” [Par 70] “FIG. 11 illustrates the first drill guide 51 in use within the patient's mouth. The first drill guide 51 may be used to place two or more implants 42 and a central guide pin 54. First, the surgeon places the first drill guide 51 in the patient's mouth on the patient's posterior teeth and shapes the jaw bone until the guide 51 seats on the cusps of the posterior teeth. Next the metal tubes 52 in the guide 51 are used to drill holes in the jaw bone at the proper angulation and depth. Actual dental implants 42 may be placed in two or more of the drill sites.”) and providing, by the processor, and ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) ([Par 50] “At a step 614, CT data is rendered as .stl files for specific anatomic structures and for casts and the radiographic markers are located in the CT scan. At step 616, the provider manipulates the 3D files of the upper and lower casts so that they have the same orientation in computer space as the CT data of the patient's anatomical structure.” [Par 83] “In one example, the remote computer may be a dentist's or other provider's computer. Using the remote computer, the provider may access the images on the processing unit 502 (or alternatively receive and store a local copy) and may modify or edit the images as desired.”) ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) ([Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants…” [Par 83] “As shown, the processing unit 502 is connected to a WAN, disclosed herein as the Internet. Using the Internet, the processing unit 502 can communicate data, including .stl files showing modeled data for manufacture … Using the Internet, data may be sent from the processing unit 502 to the remote computer 520 or the manufacturing site 522. In one example, the remote computer may be a dentist's or other provider's computer. Using the remote computer, the provider may access the images on the processing unit 502 (or alternatively receive and store a local copy) and may modify or edit the images as desired. Once edits or modifications are made the revised data may be sent back to the processing unit 502, or alternatively, may be sent directly to the manufacturing site. Once the manufacturing site 522 receives the data, it may be used to program the computer controller manufacturing machine 524 to create the intra oral devices.” [Examiner’s note: par 83 describes the provider/dentist altering the virtual surgical guide before manufacturing it for use in a procedure]) and performance of the actual surgical plan for the patient. ([Par 89] “In one aspect, manufacturing the first drill guide includes: transferring code based on the first virtual drill guide to a CNC mill; and milling the drill guide on a CNC mill. In one aspect, the method comprises inserting metal tubes into holes in the milled guide. In one aspect, the method comprises: removing bone tissue from the jaw to provide space for restorative materials; and using the first surgical drill guide as a reference to determine whether the bone tissue removed is a sufficient amount. In one aspect, using the first surgical drill guide as a reference includes removing jaw bone tissue until the first surgical guide rests on three cusp tips of teeth.”)
Schmitt does not explicitly teach generating data including a virtual surgical guide for guiding dental operations on an open mouth; using axial CT or CB scan data; performing dental operations on the patient’s open mouth; positioning an element in the opposing anatomical region; determining a measurement between a top of an element and another element; comparing the measurement to a corresponding dimension of a digital representation of surgical instrumentation data, wherein the surgical instrumentation data represents at least one dimension of one or more candidate surgical instruments to be used; and determining whether the surgical instrumentation data fits within the spatial constraints imposed by the anatomical structures or the virtual surgery guide, wherein determining whether the surgical instrumentation data fits within the spatial constraints comprises: a prediction of whether the one or more candidate surgical instruments will fit in the patient's oral cavity with the patient’s mouth open; providing, based on the prediction with the patient’s mouth open, guidance about whether the surgical plan should be altered
Fenick makes obvious ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: determining if a patient’s mouth is too small for a tool to fit involves comparing the dimensions of the patient’s mouth to the dimensions of the tool. Note that determining if there is enough headroom to position the drill to align with the guide sleeve involves measuring the distance between the top of the guide sleeve (an example of a surgical guide) and the dental structures on the opposing jaw]) ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: determining if a patient’s mouth is too small for a tool to fit involves comparing the dimensions of the patient’s mouth to the dimensions of the tool. Note that determining if there is enough headroom to position the drill to align with the guide sleeve involves measuring the distance between the top of the guide sleeve (an example of a surgical guide) and the dental structures on the opposing jaw])
Fenick is analogous art because it is within the field of dentistry, it would have been obvious to one of ordinary skill in the art to combine Schmitt with Fenick before the time of invention. One of ordinary skill in the art would have been motivated to make this combination in order to better plan dental procedures, particularly in relation to bone structure, and therefore extend implant life and durability. As stated by Fenick, locating sufficient bone structure to anchor an implant to can be an incredibly difficult and fallible process. ([Col 1 line 19-29] “However, a problem in the art and science of placing tooth implants into a patient's mouth was finding or locating sufficient bone structure in which to fix the implant so as to obtain the most optimum results. As the bone structure and/or the density or mass thereof is not readily apparent, implants have frequently been placed into a location where there is insufficient bone structure to form a suitable anchoring position for the implant. The ultimate consequence thereof was a failure of the implant in a relatively brief period of time.”) Fenick points out the need for a system capable of determining an optimal implantation plan to extend implant life. To this end, Fenick presents a comprehensive implantation planning suite capable of determining the optimal location and path of both an implant and the requisite instrumentation for installing said implant. ([Col 1 line 50-66] “Another object is to provide a method for facilitating the drilling of a bore into the most optimal bone structure of a patient's jaw to define the most desirable seat for an implant fixture… Another object is to provide a casting of a patient's teeth formed with a guide for directing a drill along a predetermined trajectory into the most optimal bone structure of a patient's jaw to define the seat for a tooth implant fixture…. Another object is to provide a method and device for accurately transferring the most optimal implant trajectory as determined by an actual oblique X-ray of a patient's jaw to a model of the patient's teeth. [Col 2 line 7- 61] “The foregoing objects and other features and advantages are attained by a method of imbedding a tooth implant into the most optimal bone structure of a patient's tooth by first making a model of a patient's teeth in the vicinity of the implant void. Upon completion of the model, one or more artificial teeth are positioned on the model in the implant void thereon to determine the occlusal and aesthetic positions of the contemplated implant. Upon the determination of the optimum arrangement of the contemplated implants, a casting or stent is made of the model with the artificial teeth in place…. The casting or stent so formed is then placed onto the teeth in the mouth of the patient an a diagnostic evaluation is made of a patient's mouth by taking a series of oblique X-ray views in the vicinity of the implant area to establish a trajectory into the most optimal bone structure for drilling the seat or bore into which the implant fixture is to be anchored… A second casting is made to the patient's model so as to fix the position of the guide sleeve relative to the patient's teeth. With the second casting in place onto one's teeth, the seat for the implant can be precisely drilled into the optimal bone structure as the guide sleeve functions to guide the drill bit along the predetermined trajectory to form the implant seat in the most optimal bone structure.”) Overall, one of ordinary skill in the art would recognize that combining Schmitt with Fenick would result in a system capable of generating better dental procedures in which implants are significantly more durable and last much longer.
The combination of Schmitt and Fenick does not explicitly teach generating data including a virtual surgical guide for guiding dental operations on an open mouth; using axial CT or CB scan data; performing dental operations on the patient’s open mouth; positioning an element in the opposing anatomical region; a digital representation of surgical instrumentation data; the patient’s oral cavity with the patient’s mouth open; providing, with the patient’s mouth open, guidance about whether the surgical plan should be altered
Boerjes makes obvious generating data including a virtual surgical guide for guiding dental operations ([Par 221] “ Figs. 7A and 7B show a modeling environment for creating alignment guides for orthodontic hardware. A three-dimensional representation 702 of dentition and surrounding soft tissue may be acquired from a dental patient as described generally above, and rendered within a user interface 704 on a computer such as the image” [Par 70] “transforming the three-dimensional representation into a digital dental model, the digital dental model including one or more orthodontic fixture alignment guides; and generating a virtual orthodontic fixture using the alignment guides.”) on an open mouth; ([Fig. 1] Shows a dental operation being performed on a patient’s open mouth.) ([Fig. 1] Shows a dental operation being performed on a patient’s open mouth.) positioning an element in the opposing anatomical region; ([Par 148] “The touch screen may provide one or more tools for virtually designing a dental restoration fitted to a dental model, including fitting to a prepared surface, adjacent teeth, and/or teeth of an opposing arch.” a digital representation of surgical instrumentation data; ([Par 22] “ The dental object may include a dental prosthesis, a dental implant, a dental appliance, a dental restoration, a restorative component, or an abutment.” [Par 31] “ A computer program product may include computer executable code embodied in a computer readable medium that, when executed on one or more computer devices, performs the steps of: acquiring one or more images of a dental object; converting the one or more images of the dental object into a first three- dimensional representation of the item;”) the patient’s oral cavity with the patient’s mouth open; ([Fig. 1] Shows a dental operation being performed on a patient’s open mouth.) providing, with the patient’s mouth open, ([Fig. 1] Shows a dental operation being performed on a patient’s open mouth.) guidance about whether the surgical plan should be altered ([Par 36-37 “In another aspect, a method disclosed herein includes a single dental visit, the steps of: acquiring a three-dimensional representation of one or more intraoral structures from a dental patient, the intraoral structures may include at least one tooth surface prepared for an artificial dental object; and processing the three- dimensional representation to provide feedback to a dentist concerning the at least one tooth surface … The feedback may identify corrective action… The feedback may include a visual display recommending additional preparatory work required for the at least one tooth surface. The feedback may include a visual display recommending acquiring additional three-dimensional representations of one or more regions of the one or more intraoral structures.”)
Boerjes is analogous art because it is within the field of dental operation planning. It would have been obvious to one of ordinary skill in the art to combine it with Schmitt and Fenick before the time of invention. One of ordinary skill in the art would have been motivated to make this combination in order to further integrate digital technologies into the dental planning process, enabling higher-quality procedures. As noted by Boerjes, there was a distinct lack of high quality digital dental design tools around the time of invention, particularly of tools capable of high quality 3D scanning ([Par 4-5] “However, advances in dentistry have been muted, at least in part due to the inability to easily capture adequate three-dimensional data for teeth and surrounding soft tissue. In addition, dentistry has achieved only limited gains from general improvements in manufacturing technologies because each dental patient and restoration presents a unique, one-off product. There remains a need for dentistry tools that capture high-quality digital dental models, as well as tools that permit the design and manufacture of dental hardware from such models.”) One of ordinary skill in the art would have recognized that the ability to capture high quality 3D scans of a patient’s mouth would in turn enable the development of much higher quality, better fitted implants and dental devices. To this end, Boerjes introduces a comprehensive, high-detail dental scanning system capable of creating more accurate models of teeth and surrounding tissues. ([Par 6-7] “The systems and methods disclosed herein employ a scanning system for capturing highly detailed digital dental models. These models may be used within a dentist's office for a wide array of dental functions including quality control, restoration design, and fitting. These models may also, or instead, be transmitted to dental laboratories that may, alone or in collaboration with the originating dentist or other dental professionals, transform the digital model into a physical realization of a dental hardware item. A method disclosed herein includes acquiring a three-dimensional representation of one or more intraoral structures of a dental patient using an intraoral scanner; and providing the three-dimensional representation to a dental fabrication facility.”) Overall, one of ordinary skill in the art would have recognized that combining the high-resolution oral scanning system of Boerjes with the dental procedure planning systems of Schmitt and Fenick would result in a significantly more robust dental operations suite, enabling the creation of more accurate, better fitting implants and restorations.
The combination of Schmitt, Fenick, and Boerjes does not explicitly teach using axial CT or CB scan data;
Suryanarayanan makes obvious using axial CT or CB scan data; ([Page 3 Par 12] “Referring generally to FIG. 2, the exemplary imaging system used in this embodiment may be CT scanning system 50.” [Page 4 Par 4] “Although FIG. 2 depicts a two-dimensional axial slice as the image 64, in practice, the image 64 can also be a volume rendering such as volume rendering and / or surface rendering. These volume rendering techniques allow 3D visualization by the operator and can provide more information than simply scanning a 2D axial slice” [Page 4 Par 5] “Techniques that facilitate the automation of volume image processing are shown and discussed with respect to FIG. 3 and subsequent figures. As shown in FIG. 3, image data set 70, typically a stack of 512 × 512 axial slices stored as a DICOM series, is preprocessed at step 72 prior to structural region segmentation at step 74.”)
Suryanarayanan is analogous art because it is within the field of medical CT scanning. It would have been obvious to one of ordinary skill in the art to combine it with Schmitt, Fenick, and Boerjes before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to better identify anatomical structures from each other, making the design of new guides and implants simpler as the imagery is easier to understand. Suryanarayanan points out the importance of segmentation for medical imagery interpretation and points out some serious issues caused by previous methods, particularly when dealing with imagery of the head ([Page 2 Par 5-8] “The CTA process can include a process of segmenting structures in image data such as vasculature and / or bone structure. Such region segmentation generally involves identifying which voxels of the image data are associated with a particular structure or structure of interest. Next, the segmented structure can be observed excluding the remainder of the image data, or masked from the remainder of the image data so that the structure that should have been blocked can be observed. it can. For example, in CTA, region division can be performed to identify all voxels related to the vasculature, which makes it possible to extract and observe the entire circulatory system in the imaged region. Similarly, all voxels of the bone structure can be identified and masked or subtracted from the image data, which can otherwise be obscured by a relatively impermeable bone structure. … However, segmentation of vasculature and bone structure can be complicated by various factors. For example, in CTA, it is difficult to identify and segment bone and vascular structures due to overlapping image intensity, proximity of imaged structures, limited detector resolution, calcification, and interventional devices There is. Furthermore, complex anatomical sites and subregions within the imaging volume can benefit from differential processing techniques. In particular, the complex landscape of bone and vasculature in the head and neck region can benefit from differential processing based on distinct regions of the entire region. … As a result, proper region segmentation of complex or continuous three-dimensional structures, such as the vasculature around the head and neck region, may require operator intervention or input … This process can be particularly difficult in the head and neck region due to insufficient bone boundaries observed through CT and other imaging diagnostic devices. Furthermore, the shape of the bone can change rapidly in the space of several slices, preventing the operator from using the same contour as the initial reference in more than a few slices. As a result, the operator may need to redraw or reset the contours repeatedly throughout the process, and in some cases, it takes more than an hour to process a single imaged head and neck volume. There is also. Furthermore, operator intervention can result in variations between and within users in the segmentation of structures.”) To this end, Suryanarayanan presents an improved, automated method of segmentation that overcomes the issues of previous methods ([Page 2 Par 10 – Page 3 Par 1] “ The technique provides a novel method for automatically generating a bone mask from CTA data. In particular, the technique can be useful for automatic generation of bone masks in the head and neck region. According to the present technique, the image data set can be preprocessed to facilitate region segmentation of the structure of interest, typically bone and vasculature. Data pre-processing includes removing image data associated with the table or support, dividing volume data into sub-volumes reflecting local tissue structure, and calculating gradients indicating structure edges. And / or calculating seed points that can be used during region segmentation. During the segmentation process, the bone can be actively segmented based on, for example, strength. The vasculature can be automatically segmented based on a variety of techniques including dynamic limited region growth, bubble wave connection, and / or radiation and contour propagation. If necessary, the vasculature can be smoothed after region segmentation. The vasculature can be subtracted from the segmented bone to generate a bone mask, and then the bone mask can be subtracted from the image data to generate a boneless data set. The boneless data set can be reconstructed or rendered to generate a boneless volume for viewing.”) Overall, one of ordinary skill in the art would have recognized that combining Suryanarayanan with Schmitt, Fenick, and Boerjes would result in a system that that presented dental scans in a much more user-friendly way that very clearly distinguishes structures like teeth, gums, etc. from each other, making designing guides and implants as well as procedure planning easier for the surgeon or dentist.
Claim 22. Schmitt teaches further comprising calculating, by the processor, the spatial constraint data using the 3D virtual model. ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…” [Par 51] “At step 618, the 3D file of the lower dental cast is joined to the 3D file of the mandible of the patient for unified movement in computer space. At step 620, virtual movement of the lower jaw relative to the upper jaw may be created using data from a digital recorder, static records, or average measurement. This data may have been obtained, such as when using the digital recorder, by scanning the patient's jaws while he or she moves the upper and lower jaws relative to each other, thereby tracking the pathway of relative movement. These recorders may include ultrasound, infrared, light and other methods of recording the positional relationships.”)
Claim 25. Schmitt teaches further comprising reconstructing, by the processor, the ([Par 49] “At step 612, a CT scan of the patient is taken, as shown in and discussed relative to FIG. 4. The CT scan records data of the patient's actual anatomical structure in order to render a 3D image.” [Fig. 4] Shows the CT scanning apparatus. Note that rotating the scanner around the head as depicted would capture data of both dental arches)
Suryanarayanan makes obvious axial CT or CB scan data with a 512x512 matrix ([Page 3 Par 12] “Referring generally to FIG. 2, the exemplary imaging system used in this embodiment may be CT scanning system 50.” [Page 4 Par 4] “Although FIG. 2 depicts a two-dimensional axial slice as the image 64, in practice, the image 64 can also be a volume rendering such as volume rendering and / or surface rendering. These volume rendering techniques allow 3D visualization by the operator and can provide more information than simply scanning a 2D axial slice” [Page 4 Par 5] “Techniques that facilitate the automation of volume image processing are shown and discussed with respect to FIG. 3 and subsequent figures. As shown in FIG. 3, image data set 70, typically a stack of 512 × 512 axial slices stored as a DICOM series, is preprocessed at step 72 prior to structural region segmentation at step 74.”)
Claim 29. Schmitt teaches further comprising positioning, by the processor and in the 3D virtual model, a virtual representation of the at least one candidate dental implant in the 3D virtual model. ([Par 66] “FIG. 9 also shows virtual dental implants 42 placed in the lower jaw in areas that have adequate volume of bone after the teeth are extracted.”)
Claim 30. The elements of claim 30 are substantially the same as those of claim 21. Therefore, the elements of claim 30 are rejected due to the same reasons as outlined above for claim 21. Further, Schmitt makes obvious the additional elements of “at least one processor and a non-transitory computer-readable storage device operably coupled to the at least one processor and comprising instructions that, when executed by the at least one processor, configure the at least one processor to perform operations to…” ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”).
Claim 31. The elements of claims 31 are substantially the same as those of claim 22. Therefore, the elements of claim 31 are rejected due to the same reasons as outlined above for claim 22. Further, Schmitt makes obvious the additional elements of claim 30 as inherited by claim 31, particularly “at least one processor and a non-transitory computer-readable storage device operably coupled to the at least one processor and comprising instructions that, when executed by the at least one processor, configure the at least one processor to perform operations to…” ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”).
Claim 34. Schmitt teaches wherein the surgical region from which the at least one anatomical dimension is measured ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…” [Par 44] “An x-ray source 48 projects radiation across the patient's head and is detected on a sensor 50. As disclosed further below, using the data obtained from this CT scan, an image of the patient's jaws and teeth may be generated.” [Par 51] “At step 618, the 3D file of the lower dental cast is joined to the 3D file of the mandible of the patient for unified movement in computer space. At step 620, virtual movement of the lower jaw relative to the upper jaw may be created using data from a digital recorder, static records, or average measurement. This data may have been obtained, such as when using the digital recorder, by scanning the patient's jaws while he or she moves the upper and lower jaws relative to each other, thereby tracking the pathway of relative movement. These recorders may include ultrasound, infrared, light and other methods of recording the positional relationships.”) ([Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants…”) wherein when executed by the at least one processor, the instructions configure the at least one processor to ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.” [Par 81] “The processor 504 may for example be a microprocessor of a known type. The memory 506 may, in some embodiments, collectively represents two or more different types of memory. For example, the memory 506 may include a read only memory (ROM) that stores a program executed by the processor 504, as well as static data for the processor 504.”) reconstruct the ([Par 49] “At step 612, a CT scan of the patient is taken, as shown in and discussed relative to FIG. 4. The CT scan records data of the patient's actual anatomical structure in order to render a 3D image.” [Fig. 4] Shows the CT scanning apparatus. Note that rotating the scanner around the head as depicted would capture data of both arches)
Fenick makes obvious wherein a measurement corresponds to a measurement from the top surface of an element; ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: determining if a patient’s mouth is too small for a tool to fit involves comparing the dimensions of the patient’s mouth to the dimensions of the tool. Note that determining if there is enough headroom to position the drill to align with the guide sleeve involves measuring the distance between the top of the guide sleeve (an example of a surgical guide) and the dental structures on the opposing jaw])
Suryanarayanan makes obvious an axial CT or CB scan with a 512x512 matrix. ([Page 3 Par 12] “Referring generally to FIG. 2, the exemplary imaging system used in this embodiment may be CT scanning system 50.” [Page 4 Par 4] “Although FIG. 2 depicts a two-dimensional axial slice as the image 64, in practice, the image 64 can also be a volume rendering such as volume rendering and / or surface rendering. These volume rendering techniques allow 3D visualization by the operator and can provide more information than simply scanning a 2D axial slice” [Page 4 Par 5] “Techniques that facilitate the automation of volume image processing are shown and discussed with respect to FIG. 3 and subsequent figures. As shown in FIG. 3, image data set 70, typically a stack of 512 × 512 axial slices stored as a DICOM series, is preprocessed at step 72 prior to structural region segmentation at step 74.”)
Claim 41. Schmitt teaches further comprising performing an ([Par 49] “At step 612, a CT scan of the patient is taken, as shown in and discussed relative to FIG. 4. The CT scan records data of the patient's actual anatomical structure in order to render a 3D image.” [Fig. 4] Shows the CT scanning apparatus. Note that rotating the scanner around the head as depicted would capture data of both arches)
Suryanarayanan makes obvious performing an axial CT or CB scan to obtain axial CT or CB scan data ([Page 3 Par 12] “Referring generally to FIG. 2, the exemplary imaging system used in this embodiment may be CT scanning system 50.” [Page 4 Par 4] “Although FIG. 2 depicts a two-dimensional axial slice as the image 64, in practice, the image 64 can also be a volume rendering such as volume rendering and / or surface rendering. These volume rendering techniques allow 3D visualization by the operator and can provide more information than simply scanning a 2D axial slice” [Page 4 Par 5] “Techniques that facilitate the automation of volume image processing are shown and discussed with respect to FIG. 3 and subsequent figures. As shown in FIG. 3, image data set 70, typically a stack of 512 × 512 axial slices stored as a DICOM series, is preprocessed at step 72 prior to structural region segmentation at step 74.”)
Claim 42. Schmitt teaches wherein the one or more candidate surgical instruments comprises one or more of tissue punches, drill bits, counter sinks, dental implants, implant mounts, or any combination thereof. ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants” [Par 6] “The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.”)
Claim 43. Schmitt teaches wherein generating a digital surgical plan ([Par 5] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”)
Boerjes makes obvious wherein the process comprises specifying a location, orientation, and depth for placing the at least one candidate dental implant in the patient's oral cavity. ([Par 139] “ A scan may capture a three- dimensional representation of some or all of the dentition according to particular purpose of the scan. Thus the scan may capture a digital model of a tooth, a quadrant of teeth, or a full collection of teeth including two opposing arches, as well as soft tissue or any other relevant intraoral and/or extraoral structures. In other embodiments where, for example, a completed fabrication is being virtually test fit to a surface preparation, the scan may include a dental restoration such as an inlay or a crown, or any other artificial dental object.” [Examiner’s note: virtually fitting an implant in a three-dimensional environment involves specifying the position, orientation, and depth of the implant] [Par 83] “ The digital dental impression may include a case plan for the restoration. The case plan may include a type of restoration, a design of restoration, or a list of restoration components. The list of restoration components may include a full ceramic component. The list of restoration components may include a PFM component. The case plan may include a specification of one or more restoration materials.”)
Claim 44. Schmitt teaches further comprising generating, by the processor, the virtual surgical guide using the digital surgical plan and the 3D virtual model. ([Par 6] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” [Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants, and manufacturing an actual drill guide based on data of the virtual drill guide.”)
Claim 45. Schmitt teaches further comprising causing, by the processor, data representative of the virtual model to be transmitted to a manufacturer for manufacturing the actual surgical guide according to the data representative of the virtual model. ([Par 83] “As shown, the processing unit 502 is connected to a WAN, disclosed herein as the Internet. Using the Internet, the processing unit 502 can communicate data, including .stl files showing modeled data for manufacture to either a remote computer 520 or a manufacturing site 522, which in this embodiment includes a computer controlled manufacturing machine 524, which may be, for example, an NC mill or layered manufacturing machine. Other machines also are contemplated. Using the Internet, data may be sent from the processing unit 502 to the remote computer 520 or the manufacturing site 522. In one example, the remote computer may be a dentist's or other provider's computer. Using the remote computer, the provider may access the images on the processing unit 502 (or alternatively receive and store a local copy) and may modify or edit the images as desired. Once edits or modifications are made the revised data may be sent back to the processing unit 502, or alternatively, may be sent directly to the manufacturing site. Once the manufacturing site 522 receives the data, it may be used to program the computer controller manufacturing machine 524 to create the intra oral devices.” [Par 67] “Once the virtual drill guide's form and shape are determined, an actual drill guide may be manufactured by, for example, rapid prototyping or cutting with a five axis mill.”)
Claim 46. Schmitt teaches further comprising manufacturing the actual surgical guide based on the virtual surgical guide. ([Par 67] “Once the virtual drill guide's form and shape are determined, an actual drill guide may be manufactured by, for example, rapid prototyping or cutting with a five axis mill.”)
Claim 47. Schmitt teaches further comprising causing, by the processor, the digital surgical to be output ([Par 14] “In some embodiments, the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” )
Boerjes makes obvious data output in a human-readable format. ([Par 192] “Thus, for example, a user interface may provide a number interactive, three-dimensional tools such as markup tools that a dentist or other dental professional may use to measure, mark, annotate, or otherwise manipulate a digital model to evaluate suitability for subsequent processing and the creation of a physical dental object such as a restoration.” [Par 221] “The user interface may include interactive tools for virtually positioning orthodontic hardware and/or brackets for orthodontic hardware and/or alignment guides onto the three-dimensional representation 702 within the user interface 704”)
Claims 38- 40, 48-51 and 53 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schmitt (US 20080085489 A1) in view of Fenick (US 5015183 A) in further view of Boerjes (WO 2007084727 A1) as well as Suryanarayanan (JP 2005199041 A)in addition to Lovald (US 20070238069 A1)
Claim 38. Schmitt teaches A non-transitory computer readable medium comprising instructions that, when executed by at least one processor, cause the at least one processor to perform operations comprising ([Abstract] “A method is set forth for making a computer model of patient's jaws on the basis of digital information.” [Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) generating a digital surgical plan ([Par 5] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) including a virtual surgical guide for guiding placement of at least one candidate dental implant in a patient's ([Par 6] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” [Par 59] “FIG. 8C shows the virtual upper cast 45 virtual lower cast 44 and occlusal index 56 with the jaw opened the same amount as in FIG. 8B” [Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants, and manufacturing an actual drill guide based on data of the virtual drill guide.”) developing a three-dimensional (3D) virtual model of the patient's oral cavity ([Par 11] “In some embodiments, the exemplary methods and systems disclosed herein create a virtual computer model of a patient's mouth and to ideally position virtual artificial teeth in proper spatial orientation to the supporting tissues, teeth and the opposing arch.” [Par 85] “In some aspects, generating a virtual model includes scanning a portion of a patient's jaw to obtain scan data; and generating a 3-D image of the portion of the patient's jaw”) using ([Par 44] “FIG. 4 illustrates the CT bite plate assembly 10 placed in a patient's mouth and the patient positioned in a CT machine 46. An x-ray source 48 projects radiation across the patient's head and is detected on a sensor 50. As disclosed further below, using the data obtained from this CT scan, an image of the patient's jaws and teeth may be generated.”) causing, by the processor, the 3D virtual model to be displayed on an electronic display device and in a human-readable format to one or more parties responsible for placement of the at least one candidate dental implant in the patient's ([Par 55] “FIG. 7A illustrates one example of a virtual model of a virtual lower jaw 35 and virtual teeth 36 from CT data as it may appear on a computer display. The teeth 36 and roots may have a different radiographic density than the bone of the lower jaw 35, allowing a user operator to identify them by their gray-scale value relative to the gray-scale value of the lower jaw.” [Par 83] “Using the Internet, data may be sent from the processing unit 502 to the remote computer 520 or the manufacturing site 522. In one example, the remote computer may be a dentist's or other provider's computer”)receiving, from the 3D virtual model, spatial constraint data of the patient's oral cavity, wherein the spatial constraint data represents spatial constraints imposed by anatomical structures of the patient's oral cavity and includes at least one dimension measured from the surgical region to the region of the patient's opposing jaw; ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…” [Par 44] “An x-ray source 48 projects radiation across the patient's head and is detected on a sensor 50. As disclosed further below, using the data obtained from this CT scan, an image of the patient's jaws and teeth may be generated.” [Par 51] “At step 618, the 3D file of the lower dental cast is joined to the 3D file of the mandible of the patient for unified movement in computer space. At step 620, virtual movement of the lower jaw relative to the upper jaw may be created using data from a digital recorder, static records, or average measurement. This data may have been obtained, such as when using the digital recorder, by scanning the patient's jaws while he or she moves the upper and lower jaws relative to each other, thereby tracking the pathway of relative movement. These recorders may include ultrasound, infrared, light and other methods of recording the positional relationships.”) causing the virtual surgical guide to be positioned ([Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants…” [Par 65-66] “FIG. 9 illustrates the virtual model of the lower cast 44 with the cast reshaped (as indicated by the reference numeral 47) to provide space for the restoration and to have the proper contour for the dental implants 42. Areas of contact for the occlusal index 56 are indicated by the stars identified by the reference numeral 43. In addition, FIG. 9 shows that some of the images of the original patient's teeth have been re-added or have not been virtually removed. These virtual teeth may be used as reference points for creating the first virtual drill guide and may provide a stable base for the actual first drill guide after it is formed. FIG. 9 also shows virtual dental implants 42 placed in the lower jaw in areas that have adequate volume of bone after the teeth are extracted. … The lower cast is positioned in the same computer space as the virtual model of the lower jaw 35 with dental implants 42. …. In the example of FIG. 9 contact areas 43 on the surface of three teeth have been retained to allow for proper indexing of the drill guide. Since the lower cast and the CT data about the lower jaw are oriented in computer space using the CT bite plate of FIG. 3, it is possible to create a drill guide that has contact on the teeth for proper orientation, a shape that determines the correct form of the bone 47, and that also has cylinders in it to determine the correct angulation and vertical position of the dental implants 42. One exemplary method for creating the virtual guide includes using an extrusion operation to create a mass formed to precisely interface with the virtual jaw and with the remaining virtual teeth of the virtual model.”)analyzing the spatial constraint data, when executed by at least one processor, the instructions cause the at least one processor to perform operations further comprising: determining a height dimension in the 3D virtual model ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…” [Par 51] “At step 618, the 3D file of the lower dental cast is joined to the 3D file of the mandible of the patient for unified movement in computer space. At step 620, virtual movement of the lower jaw relative to the upper jaw may be created using data from a digital recorder, static records, or average measurement. This data may have been obtained, such as when using the digital recorder, by scanning the patient's jaws while he or she moves the upper and lower jaws relative to each other, thereby tracking the pathway of relative movement. These recorders may include ultrasound, infrared, light and other methods of recording the positional relationships.” [Examiner’s note: the “positional relationship of the dental implants in relation to the opposing arch” would include the height measurement]) ([Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants…”) and the region of the patient's opposing jaw; ([Par 16] “…to record the positional relationship of the dental implants in relation to the opposing arch…”) and ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…”) ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) ([Par 5] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” [Par 21] “The method may include inserting at least one first dental implant in a patient's mouth;” ) the patient's oral cavity, ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…”) ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) computing ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) plan ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) in a clinical setting with the patient's mouth ([Par 67] “Once the virtual drill guide's form and shape are determined, an actual drill guide may be manufactured by, for example, rapid prototyping or cutting with a five axis mill.” [Par 70] “FIG. 11 illustrates the first drill guide 51 in use within the patient's mouth. The first drill guide 51 may be used to place two or more implants 42 and a central guide pin 54. First, the surgeon places the first drill guide 51 in the patient's mouth on the patient's posterior teeth and shapes the jaw bone until the guide 51 seats on the cusps of the posterior teeth. Next the metal tubes 52 in the guide 51 are used to drill holes in the jaw bone at the proper angulation and depth. Actual dental implants 42 may be placed in two or more of the drill sites.”) providing, ([Par 50] “At a step 614, CT data is rendered as .stl files for specific anatomic structures and for casts and the radiographic markers are located in the CT scan. At step 616, the provider manipulates the 3D files of the upper and lower casts so that they have the same orientation in computer space as the CT data of the patient's anatomical structure.” [Par 83] “In one example, the remote computer may be a dentist's or other provider's computer. Using the remote computer, the provider may access the images on the processing unit 502 (or alternatively receive and store a local copy) and may modify or edit the images as desired.”) ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) ([Par 84] “In one exemplary aspect, the present disclosure is directed to a method of creating a surgical drill guide. The method includes the steps of generating a virtual model of a portion of a patient's jaw and introducing virtual dental implants to the virtual model. It also includes generating a virtual drill guide shaped to fit on the virtual jaw, the virtual drill guide indicating the position of the virtual dental implants…” [Par 83] “As shown, the processing unit 502 is connected to a WAN, disclosed herein as the Internet. Using the Internet, the processing unit 502 can communicate data, including .stl files showing modeled data for manufacture … Using the Internet, data may be sent from the processing unit 502 to the remote computer 520 or the manufacturing site 522. In one example, the remote computer may be a dentist's or other provider's computer. Using the remote computer, the provider may access the images on the processing unit 502 (or alternatively receive and store a local copy) and may modify or edit the images as desired. Once edits or modifications are made the revised data may be sent back to the processing unit 502, or alternatively, may be sent directly to the manufacturing site. Once the manufacturing site 522 receives the data, it may be used to program the computer controller manufacturing machine 524 to create the intra oral devices.” [Examiner’s note: par 83 describes the provider/dentist altering the virtual surgical guide before manufacturing it for use in a procedure]) and performance of the actual surgical plan for the patient; and ([Par 89] “In one aspect, manufacturing the first drill guide includes: transferring code based on the first virtual drill guide to a CNC mill; and milling the drill guide on a CNC mill. In one aspect, the method comprises inserting metal tubes into holes in the milled guide. In one aspect, the method comprises: removing bone tissue from the jaw to provide space for restorative materials; and using the first surgical drill guide as a reference to determine whether the bone tissue removed is a sufficient amount. In one aspect, using the first surgical drill guide as a reference includes removing jaw bone tissue until the first surgical guide rests on three cusp tips of teeth.”)performing one of the following operations: ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) the instructions cause the at least one processor to perform operations further comprising: ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”) implementing a change to at least one of: the one or more candidate surgical instruments, the at least one candidate dental implant, the virtual surgical guide, ([Par 83] “As shown, the processing unit 502 is connected to a WAN, disclosed herein as the Internet. Using the Internet, the processing unit 502 can communicate data, including .stl files showing modeled data for manufacture … Using the Internet, data may be sent from the processing unit 502 to the remote computer 520 or the manufacturing site 522. In one example, the remote computer may be a dentist's or other provider's computer. Using the remote computer, the provider may access the images on the processing unit 502 (or alternatively receive and store a local copy) and may modify or edit the images as desired. Once edits or modifications are made the revised data may be sent back to the processing unit 502, or alternatively, may be sent directly to the manufacturing site. Once the manufacturing site 522 receives the data, it may be used to program the computer controller manufacturing machine 524 to create the intra oral devices.”)and at least one parameter for placement of the at least one candidate dental implant; and
([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” [Par 70] “FIG. 11 illustrates the first drill guide 51 in use within the patient's mouth. The first drill guide 51 may be used to place two or more implants 42 and a central guide pin 54. First, the surgeon places the first drill guide 51 in the patient's mouth on the patient's posterior teeth and shapes the jaw bone until the guide 51 seats on the cusps of the posterior teeth. Next the metal tubes 52 in the guide 51 are used to drill holes in the jaw bone at the proper angulation and depth. Actual dental implants 42 may be placed in two or more of the drill sites.”) (b) causing an as-modified digital surgical plan ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”
Schmitt does not explicitly teach generating data including a virtual surgical guide for guiding dental operations on an open mouth; using axial CT or CB scan data; performing dental operations on the patient’s open mouth; positioning an element in the opposing anatomical region; determining a measurement between a top of an element and another element; comparing the measurement to a corresponding dimension of a digital representation of surgical instrumentation data, wherein the surgical instrumentation data represents at least one dimension of one or more candidate surgical instruments to be used; determining, based on the comparing, whether the digital model of the one or more surgical instruments fits within determining, based on the comparing, whether the digital model of the one or more surgical instruments fits within the spatial constraints imposed by the anatomical structures of the patient's oral cavity; wherein for determining whether the digital model of the one or more surgical instruments fits within the spatial constraints, operations are performed comprising: determining a prediction of whether the one or more candidate surgical instruments will fit in the patient's oral cavity with the patient’s mouth open; providing, based on the prediction with the patient’s mouth open, guidance about whether the surgical plan should be altered and (i) in response to it being determined that the digital model of the digital model of the one or more surgical instruments fits within the spatial constraints, causing data to be finalized into an as-finalized form that includes at least the one or more candidate surgical instruments; or (ii) in response to it being determined that the digital model of the digital model of the one or more surgical instruments does not fit within the spatial constraints, iterating through at least: the comparing and the computing operations until it is predicted that the one or more candidate surgical instruments will fit in the patient’s mouth; and causing a plan to be finalized into an as- finalized form when it is determined that the digital model of the one or more surgical instruments will fit within the spatial constraints.
Fenick makes obvious ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: determining if a patient’s mouth is too small for a tool to fit involves comparing the dimensions of the patient’s mouth to the dimensions of the tool. Note that determining if there is enough headroom to position the drill to align with the guide sleeve involves measuring the distance between the top of the guide sleeve (an example of a surgical guide) and the dental structures on the opposing jaw]) ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: determining if a patient’s mouth is too small for a tool to fit involves comparing the dimensions of the patient’s mouth to the dimensions of the tool. Note that determining if there is enough headroom to position the drill to align with the guide sleeve involves measuring the distance between the top of the guide sleeve (an example of a surgical guide) and the dental structures on the opposing jaw]) (i) in response to it being determined that ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: this method determines whether or not the instrument will fit, i.e. it determines if the instruments fit and if the instruments do not fit]) ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: this method determines whether or not the instrument will fit, i.e. it determines if the instruments fit and if the instruments do not fit]) ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.”) ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.”)
Fenick is analogous art because it is within the field of dentistry, it would have been obvious to one of ordinary skill in the art to combine Schmitt with Fenick before the time of invention. One of ordinary skill in the art would have been motivated to make this combination in order to better plan dental procedures, particularly in relation to bone structure, and therefore extend implant life and durability. As stated by Fenick, locating sufficient bone structure to anchor an implant to can be an incredibly difficult and fallible process. ([Col 1 line 19-29] “However, a problem in the art and science of placing tooth implants into a patient's mouth was finding or locating sufficient bone structure in which to fix the implant so as to obtain the most optimum results. As the bone structure and/or the density or mass thereof is not readily apparent, implants have frequently been placed into a location where there is insufficient bone structure to form a suitable anchoring position for the implant. The ultimate consequence thereof was a failure of the implant in a relatively brief period of time.”) Fenick points out the need for a system capable of determining an optimal implantation plan to extend implant life. To this end, Fenick presents a comprehensive implantation planning suite capable of determining the optimal location and path of both an implant and the requisite instrumentation for installing said implant. ([Col 1 line 50-66] “Another object is to provide a method for facilitating the drilling of a bore into the most optimal bone structure of a patient's jaw to define the most desirable seat for an implant fixture… Another object is to provide a casting of a patient's teeth formed with a guide for directing a drill along a predetermined trajectory into the most optimal bone structure of a patient's jaw to define the seat for a tooth implant fixture…. Another object is to provide a method and device for accurately transferring the most optimal implant trajectory as determined by an actual oblique X-ray of a patient's jaw to a model of the patient's teeth. [Col 2 line 7- 61] “The foregoing objects and other features and advantages are attained by a method of imbedding a tooth implant into the most optimal bone structure of a patient's tooth by first making a model of a patient's teeth in the vicinity of the implant void. Upon completion of the model, one or more artificial teeth are positioned on the model in the implant void thereon to determine the occlusal and aesthetic positions of the contemplated implant. Upon the determination of the optimum arrangement of the contemplated implants, a casting or stent is made of the model with the artificial teeth in place…. The casting or stent so formed is then placed onto the teeth in the mouth of the patient an a diagnostic evaluation is made of a patient's mouth by taking a series of oblique X-ray views in the vicinity of the implant area to establish a trajectory into the most optimal bone structure for drilling the seat or bore into which the implant fixture is to be anchored… A second casting is made to the patient's model so as to fix the position of the guide sleeve relative to the patient's teeth. With the second casting in place onto one's teeth, the seat for the implant can be precisely drilled into the optimal bone structure as the guide sleeve functions to guide the drill bit along the predetermined trajectory to form the implant seat in the most optimal bone structure.”) Overall, one of ordinary skill in the art would recognize that combining Schmitt with Fenick would result in a system capable of generating better dental procedures in which implants are significantly more durable and last much longer.
The combination of Schmitt and Fenick does not explicitly teach generating data including a virtual surgical guide for guiding dental operations on an open mouth; using axial CT or CB scan data; performing dental operations on the patient’s open mouth; positioning an element in the opposing anatomical region; a digital model of surgical instrumentation data; the digital model of the one or more surgical instruments; the patient’s oral cavity with the patient’s mouth open; providing, with the patient’s mouth open, guidance about whether the surgical plan should be altered and the digital model of the digital model of the surgical instruments; causing data to be finalized into an as-finalized form that includes at least the one or more candidate surgical instruments; the digital model of the digital model of the one or more surgical instruments; iterating through at least: processing steps until an end state is reached and causing data to be finalized into an as- finalized form; the digital model of the one or more surgical instruments;
Boerjes makes obvious generating data including a virtual surgical guide for guiding dental operations ([Par 221] “ Figs. 7A and 7B show a modeling environment for creating alignment guides for orthodontic hardware. A three-dimensional representation 702 of dentition and surrounding soft tissue may be acquired from a dental patient as described generally above, and rendered within a user interface 704 on a computer such as the image” [Par 70] “transforming the three-dimensional representation into a digital dental model, the digital dental model including one or more orthodontic fixture alignment guides; and generating a virtual orthodontic fixture using the alignment guides.”) on an open mouth; ([Fig. 1] Shows a dental operation being performed on a patient’s open mouth.) ([Fig. 1] Shows a dental operation being performed on a patient’s open mouth.) positioning an element in the opposing anatomical region; ([Par 148] “The touch screen may provide one or more tools for virtually designing a dental restoration fitted to a dental model, including fitting to a prepared surface, adjacent teeth, and/or teeth of an opposing arch.”) a digital model of surgical instrumentation data; the digital model of the one or more surgical instruments([Par 22] “ The dental object may include a dental prosthesis, a dental implant, a dental appliance, a dental restoration, a restorative component, or an abutment.” [Par 31] “ A computer program product may include computer executable code embodied in a computer readable medium that, when executed on one or more computer devices, performs the steps of: acquiring one or more images of a dental object; converting the one or more images of the dental object into a first three- dimensional representation of the item;”) the patient’s oral cavity with the patient’s mouth open; ([Fig. 1] Shows a dental operation being performed on a patient’s open mouth.) providing, with the patient’s mouth open, ([Fig. 1] Shows a dental operation being performed on a patient’s open mouth.) guidance about whether the surgical plan should be altered and([Par 36-37 “In another aspect, a method disclosed herein includes a single dental visit, the steps of: acquiring a three-dimensional representation of one or more intraoral structures from a dental patient, the intraoral structures may include at least one tooth surface prepared for an artificial dental object; and processing the three- dimensional representation to provide feedback to a dentist concerning the at least one tooth surface … The feedback may identify corrective action… The feedback may include a visual display recommending additional preparatory work required for the at least one tooth surface. The feedback may include a visual display recommending acquiring additional three-dimensional representations of one or more regions of the one or more intraoral structures.”) the digital model of the digital model of the one or more surgical instruments; ([Par 22] “ The dental object may include a dental prosthesis, a dental implant, a dental appliance, a dental restoration, a restorative component, or an abutment.” [Par 31] “ A computer program product may include computer executable code embodied in a computer readable medium that, when executed on one or more computer devices, performs the steps of: acquiring one or more images of a dental object; converting the one or more images of the dental object into a first three- dimensional representation of the item;”) ([Par 22] “ The dental object may include a dental prosthesis, a dental implant, a dental appliance, a dental restoration, a restorative component, or an abutment.” [Par 31] “ A computer program product may include computer executable code embodied in a computer readable medium that, when executed on one or more computer devices, performs the steps of: acquiring one or more images of a dental object; converting the one or more images of the dental object into a first three- dimensional representation of the item;”) ([Par 22] “ The dental object may include a dental prosthesis, a dental implant, a dental appliance, a dental restoration, a restorative component, or an abutment.” [Par 31] “ A computer program product may include computer executable code embodied in a computer readable medium that, when executed on one or more computer devices, performs the steps of: acquiring one or more images of a dental object; converting the one or more images of the dental object into a first three- dimensional representation of the item;”)
Boerjes is analogous art because it is within the field of dental operation planning. It would have been obvious to one of ordinary skill in the art to combine it with Schmitt and Fenick before the time of invention. One of ordinary skill in the art would have been motivated to make this combination in order to further integrate digital technologies into the dental planning process, enabling higher-quality procedures. As noted by Boerjes, there was a distinct lack of high quality digital dental design tools around the time of invention, particularly of tools capable of high quality 3D scanning ([Par 4-5] “However, advances in dentistry have been muted, at least in part due to the inability to easily capture adequate three-dimensional data for teeth and surrounding soft tissue. In addition, dentistry has achieved only limited gains from general improvements in manufacturing technologies because each dental patient and restoration presents a unique, one-off product. There remains a need for dentistry tools that capture high-quality digital dental models, as well as tools that permit the design and manufacture of dental hardware from such models.”) One of ordinary skill in the art would have recognized that the ability to capture high quality 3D scans of a patient’s mouth would in turn enable the development of much higher quality, better fitted implants and dental devices. To this end, Boerjes introduces a comprehensive, high-detail dental scanning system capable of creating more accurate models of teeth and surrounding tissues. ([Par 6-7] “The systems and methods disclosed herein employ a scanning system for capturing highly detailed digital dental models. These models may be used within a dentist's office for a wide array of dental functions including quality control, restoration design, and fitting. These models may also, or instead, be transmitted to dental laboratories that may, alone or in collaboration with the originating dentist or other dental professionals, transform the digital model into a physical realization of a dental hardware item. A method disclosed herein includes acquiring a three-dimensional representation of one or more intraoral structures of a dental patient using an intraoral scanner; and providing the three-dimensional representation to a dental fabrication facility.”) Overall, one of ordinary skill in the art would have recognized that combining the high-resolution oral scanning system of Boerjes with the dental procedure planning systems of Schmitt and Fenick would result in a significantly more robust dental operations suite, enabling the creation of more accurate, better fitting implants and restorations.
The combination of Schmitt, Fenick, and Boerjes does not explicitly teach using axial CT or CB scan data; causing data to be finalized into an as-finalized form that includes at least the one or more surgical elements; iterating through at least: processing steps until an end state is reached and causing data to be finalized into an as- finalized form
Suryanarayanan makes obvious using axial CT or CB scan data; ([Page 3 Par 12] “Referring generally to FIG. 2, the exemplary imaging system used in this embodiment may be CT scanning system 50.” [Page 4 Par 4] “Although FIG. 2 depicts a two-dimensional axial slice as the image 64, in practice, the image 64 can also be a volume rendering such as volume rendering and / or surface rendering. These volume rendering techniques allow 3D visualization by the operator and can provide more information than simply scanning a 2D axial slice” [Page 4 Par 5] “Techniques that facilitate the automation of volume image processing are shown and discussed with respect to FIG. 3 and subsequent figures. As shown in FIG. 3, image data set 70, typically a stack of 512 × 512 axial slices stored as a DICOM series, is preprocessed at step 72 prior to structural region segmentation at step 74.”)
Suryanarayanan is analogous art because it is within the field of medical CT scanning. It would have been obvious to one of ordinary skill in the art to combine it with Schmitt, Fenick, and Boerjes before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to better identify anatomical structures from each other, making the design of new guides and implants simpler as the imagery is easier to understand. Suryanarayanan points out the importance of segmentation for medical imagery interpretation and points out some serious issues caused by previous methods, particularly when dealing with imagery of the head ([Page 2 Par 5-8] “The CTA process can include a process of segmenting structures in image data such as vasculature and / or bone structure. Such region segmentation generally involves identifying which voxels of the image data are associated with a particular structure or structure of interest. Next, the segmented structure can be observed excluding the remainder of the image data, or masked from the remainder of the image data so that the structure that should have been blocked can be observed. it can. For example, in CTA, region division can be performed to identify all voxels related to the vasculature, which makes it possible to extract and observe the entire circulatory system in the imaged region. Similarly, all voxels of the bone structure can be identified and masked or subtracted from the image data, which can otherwise be obscured by a relatively impermeable bone structure. … However, segmentation of vasculature and bone structure can be complicated by various factors. For example, in CTA, it is difficult to identify and segment bone and vascular structures due to overlapping image intensity, proximity of imaged structures, limited detector resolution, calcification, and interventional devices There is. Furthermore, complex anatomical sites and subregions within the imaging volume can benefit from differential processing techniques. In particular, the complex landscape of bone and vasculature in the head and neck region can benefit from differential processing based on distinct regions of the entire region. … As a result, proper region segmentation of complex or continuous three-dimensional structures, such as the vasculature around the head and neck region, may require operator intervention or input … This process can be particularly difficult in the head and neck region due to insufficient bone boundaries observed through CT and other imaging diagnostic devices. Furthermore, the shape of the bone can change rapidly in the space of several slices, preventing the operator from using the same contour as the initial reference in more than a few slices. As a result, the operator may need to redraw or reset the contours repeatedly throughout the process, and in some cases, it takes more than an hour to process a single imaged head and neck volume. There is also. Furthermore, operator intervention can result in variations between and within users in the segmentation of structures.”) To this end, Suryanarayanan presents an improved, automated method of segmentation that overcomes the issues of previous methods ([Page 2 Par 10 – Page 3 Par 1] “ The technique provides a novel method for automatically generating a bone mask from CTA data. In particular, the technique can be useful for automatic generation of bone masks in the head and neck region. According to the present technique, the image data set can be preprocessed to facilitate region segmentation of the structure of interest, typically bone and vasculature. Data pre-processing includes removing image data associated with the table or support, dividing volume data into sub-volumes reflecting local tissue structure, and calculating gradients indicating structure edges. And / or calculating seed points that can be used during region segmentation. During the segmentation process, the bone can be actively segmented based on, for example, strength. The vasculature can be automatically segmented based on a variety of techniques including dynamic limited region growth, bubble wave connection, and / or radiation and contour propagation. If necessary, the vasculature can be smoothed after region segmentation. The vasculature can be subtracted from the segmented bone to generate a bone mask, and then the bone mask can be subtracted from the image data to generate a boneless data set. The boneless data set can be reconstructed or rendered to generate a boneless volume for viewing.”) Overall, one of ordinary skill in the art would have recognized that combining Suryanarayanan with Schmitt, Fenick, and Boerjes would result in a system that that presented dental scans in a much more user-friendly way that very clearly distinguishes structures like teeth, gums, etc. from each other, making designs for guides and implants and procedure planning easier for the surgeon or dentist.
The combination of Schmitt, Fenick, Boerjes, and Suryanarayanan does not explicitly teach causing data to be finalized into an as-finalized form that includes at least the one or more surgical elements; iterating through at least: processing steps until an end state is reached and causing data to be finalized into an as- finalized form
Lovald makes obvious causing data to be finalized into an as-finalized form that includes at least the one or more surgical elements; iterating through at least: processing steps until an end state is reached and causing data to be finalized into an as- finalized form ([Abstract] “An implant for osteosynthesis used in the stabilization of fractured bone of the mandible. … The plate design can be modified to accommodate patient anatomy depending on the type of bone it is designed to stabilize. Design and size parameters of the fixation plate can be customized to each individual patient using a customization software application to determine the least invasive fixation plate that will provide adequate functioning in stabilizing the bone fracture to a degree that will allow safe bone healing. The invention includes a method of design of osteosynthesis plates using shape optimization for different types and locations of fractures.” [Par 45] “The application performs a multiple of analyses varying design and size parameters of the osteosynthesis plate. The software application will determine a set of design and size parameters of all possible fixation plate configurations that record output measures of any of stress, strain, and displacement that are within a threshold set in accordance with safe implant functioning and adequate fracture healing. This iterative process is indicated in Boxes 37 to 42. The software designates the best choice of osteosynthesis plate from the set of possible plates determined to be within these safety guidelines as indicated in Box 43. For example, the best choice could be the least intrusive osteosynthesis plate configuration that will perform adequately according to the output measures. The intrusion of the fixation plate could, for example, be based on the volume of the fixation plate.”)
Lovald is analogous art because it is within the field of dental surgery. It would have been obvious to one of ordinary skill in the art to combine it with Schmitt, Fenick, Boerjes, and Suryanarayanan before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to optimize implantation. As noted by Lovald, while using software to plan dental surgery was known to the art, previous attempts did not effectively handle selection and optimization of the implants themselves ([Par 9] “U.S. Pat. No. 6,711,432 to Krause, et al, issued Mar. 23, 2004 describes the devices and methods for implementing computer aided surgical procedures and more specifically devices and methods for implementing a computer-aided orthopedic surgery utilizing intra-operative feedback. A three-dimensional model of an area of a patient upon which a surgical procedure is to be performed is modeled using software techniques. The software model is used to generate a surgical plan, including placement of multifunctional markers, for performing the surgical procedure. After the markers are placed on the patient, an updated image of the patient is taken and used to calculate a final surgical plan for performing the remainder of the surgical procedure. The three-dimensional modeling, surgical planning, and surgery may all take place remote from each other. … The problem with this method is that the software does not output any information as to the appropriate implant to use for the surgery nor does it output any information pertaining to the design parameters of an implant that would provide the best functioning for each patient. In the case of osteosynthesis, software of this nature should provide information describing design characteristics for an implant that will provide an environment for adequate fracture healing in each patient.”) To this end, Lovald presents a method for geometric optimization of the implants themselves to best suit a patient’s needs ([Abstract] “The plate design can be modified to accommodate patient anatomy depending on the type of bone it is designed to stabilize. Design and size parameters of the fixation plate can be customized to each individual patient using a customization software application to determine the least invasive fixation plate that will provide adequate functioning in stabilizing the bone fracture to a degree that will allow safe bone healing. The invention includes a method of design of osteosynthesis plates using shape optimization for different types and locations of fractures.” [Par 11] “The object of this invention is to create a plate of an optimal structure for osteosynthesis in that the implant provides maximal stability across the bone fracture while remaining minimally intrusive upon the patient. The design of the implant is done through shape optimization using a finite element or other mathematical solver. Size and shape parameters of each osteosynthesis plate can be customized to ensure adequate functionality and minimal invasiveness to each patient.”) Overall, one of ordinary skill in the art would have recognized that combining Lovald with Schmitt, Fenick, Boerjes, and Suryanarayanan would result in a system that allowed dynamic selection and generation of dental implants that were better suited to each patient.
Claim 39. Schmitt teaches wherein, when executed by the at least one processor, the instructions cause the at least one processor to calculate the spatial constraint data using the 3D virtual model. ([Par 16] “ In some embodiments, the exemplary methods and systems disclosed herein provide a novel dental implant placement method to ideally position dental implants in supporting bone and to record the positional relationship of the dental implants in relation to the opposing arch for the connection of the immediate load prosthesis to dental implants.” [Par 9] “…reveals a method of tracking the positional relationship of the upper and lower jaw with static records (wax bites) average measurements and a digital recording device…” [Par 51] “At step 618, the 3D file of the lower dental cast is joined to the 3D file of the mandible of the patient for unified movement in computer space. At step 620, virtual movement of the lower jaw relative to the upper jaw may be created using data from a digital recorder, static records, or average measurement. This data may have been obtained, such as when using the digital recorder, by scanning the patient's jaws while he or she moves the upper and lower jaws relative to each other, thereby tracking the pathway of relative movement. These recorders may include ultrasound, infrared, light and other methods of recording the positional relationships.”)
Claim 40. Schmitt makes obvious wherein when executed by the at least one processor, the instructions cause the at least one processor ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.” [Par 81] “The processor 504 may for example be a microprocessor of a known type. The memory 506 may, in some embodiments, collectively represents two or more different types of memory. For example, the memory 506 may include a read only memory (ROM) that stores a program executed by the processor 504, as well as static data for the processor 504.”) to reconstruct the ([Par 49] “At step 612, a CT scan of the patient is taken, as shown in and discussed relative to FIG. 4. The CT scan records data of the patient's actual anatomical structure in order to render a 3D image.” [Fig. 4] Shows the CT scanning apparatus. Note that rotating the scanner around the head as depicted would capture data of both arches)
Suryanarayanan makes obvious axial CT or CB scan data with a 512x512 matrix ([Page 3 Par 12] “Referring generally to FIG. 2, the exemplary imaging system used in this embodiment may be CT scanning system 50.” [Page 4 Par 4] “Although FIG. 2 depicts a two-dimensional axial slice as the image 64, in practice, the image 64 can also be a volume rendering such as volume rendering and / or surface rendering. These volume rendering techniques allow 3D visualization by the operator and can provide more information than simply scanning a 2D axial slice” [Page 4 Par 5] “Techniques that facilitate the automation of volume image processing are shown and discussed with respect to FIG. 3 and subsequent figures. As shown in FIG. 3, image data set 70, typically a stack of 512 × 512 axial slices stored as a DICOM series, is preprocessed at step 72 prior to structural region segmentation at step 74.”)
Claim 48. Schmitt teaches ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”)
Fenick makes obvious in response to determining that the surgical instrumentation data fits within the spatial constraints, ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: this method determines whether or not the instrument will fit, i.e. it determines if the instruments fit and if the instruments do not fit])
Boerjes makes obvious ([Par 22] “ The dental object may include a dental prosthesis, a dental implant, a dental appliance, a dental restoration, a restorative component, or an abutment.” [Par 31] “ A computer program product may include computer executable code embodied in a computer readable medium that, when executed on one or more computer devices, performs the steps of: acquiring one or more images of a dental object; converting the one or more images of the dental object into a first three- dimensional representation of the item;”)
The combination of Schmitt, Fenick, Boerjes, and Suryanarayanan does not explicitly teach causing data to be finalized into an as-finalized form that includes at least the one or more surgical elements;
Lovald makes obvious causing data to be finalized into an as-finalized form that includes at least the one or more surgical elements; ([Abstract] “An implant for osteosynthesis used in the stabilization of fractured bone of the mandible. … The plate design can be modified to accommodate patient anatomy depending on the type of bone it is designed to stabilize. Design and size parameters of the fixation plate can be customized to each individual patient using a customization software application to determine the least invasive fixation plate that will provide adequate functioning in stabilizing the bone fracture to a degree that will allow safe bone healing. The invention includes a method of design of osteosynthesis plates using shape optimization for different types and locations of fractures.” [Par 45] “The application performs a multiple of analyses varying design and size parameters of the osteosynthesis plate. The software application will determine a set of design and size parameters of all possible fixation plate configurations that record output measures of any of stress, strain, and displacement that are within a threshold set in accordance with safe implant functioning and adequate fracture healing. This iterative process is indicated in Boxes 37 to 42. The software designates the best choice of osteosynthesis plate from the set of possible plates determined to be within these safety guidelines as indicated in Box 43. For example, the best choice could be the least intrusive osteosynthesis plate configuration that will perform adequately according to the output measures. The intrusion of the fixation plate could, for example, be based on the volume of the fixation plate.”)
Lovald is analogous art because it is within the field of dental surgery. It would have been obvious to one of ordinary skill in the art to combine it with Schmitt, Fenick, Boerjes, and Suryanarayanan before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to optimize implantation. As noted by Lovald, while using software to plan dental surgery was known to the art, previous attempts did not effectively handle selection and optimization of the implants themselves ([Par 9] “U.S. Pat. No. 6,711,432 to Krause, et al, issued Mar. 23, 2004 describes the devices and methods for implementing computer aided surgical procedures and more specifically devices and methods for implementing a computer-aided orthopedic surgery utilizing intra-operative feedback. A three-dimensional model of an area of a patient upon which a surgical procedure is to be performed is modeled using software techniques. The software model is used to generate a surgical plan, including placement of multifunctional markers, for performing the surgical procedure. After the markers are placed on the patient, an updated image of the patient is taken and used to calculate a final surgical plan for performing the remainder of the surgical procedure. The three-dimensional modeling, surgical planning, and surgery may all take place remote from each other. … The problem with this method is that the software does not output any information as to the appropriate implant to use for the surgery nor does it output any information pertaining to the design parameters of an implant that would provide the best functioning for each patient. In the case of osteosynthesis, software of this nature should provide information describing design characteristics for an implant that will provide an environment for adequate fracture healing in each patient.”) To this end, Lovald presents a method for geometric optimization of the implants themselves to best suit a patient’s needs ([Abstract] “The plate design can be modified to accommodate patient anatomy depending on the type of bone it is designed to stabilize. Design and size parameters of the fixation plate can be customized to each individual patient using a customization software application to determine the least invasive fixation plate that will provide adequate functioning in stabilizing the bone fracture to a degree that will allow safe bone healing. The invention includes a method of design of osteosynthesis plates using shape optimization for different types and locations of fractures.” [Par 11] “The object of this invention is to create a plate of an optimal structure for osteosynthesis in that the implant provides maximal stability across the bone fracture while remaining minimally intrusive upon the patient. The design of the implant is done through shape optimization using a finite element or other mathematical solver. Size and shape parameters of each osteosynthesis plate can be customized to ensure adequate functionality and minimal invasiveness to each patient.”) Overall, one of ordinary skill in the art would have recognized that combining Lovald with Schmitt, Fenick, Boerjes, and Suryanarayanan would result in a system that allowed dynamic selection and generation of dental implants that were better suited to each patient.
Claim 49. Schmitt teaches wherein the digital surgical plan([Par 5] “ The present invention relates to a method of evaluating a patient's anatomy prior to tooth removal and planning the ideal position of artificial teeth, creating surgical templates to shape bone and a method of drilling and installing dental implants.” [Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”)
Lovald makes obvious wherein the data in the as- finalized form further includes the one or more candidate dental implants. ([Abstract] “An implant for osteosynthesis used in the stabilization of fractured bone of the mandible. … The plate design can be modified to accommodate patient anatomy depending on the type of bone it is designed to stabilize. Design and size parameters of the fixation plate can be customized to each individual patient using a customization software application to determine the least invasive fixation plate that will provide adequate functioning in stabilizing the bone fracture to a degree that will allow safe bone healing. The invention includes a method of design of osteosynthesis plates using shape optimization for different types and locations of fractures.” [Par 45] “The application performs a multiple of analyses varying design and size parameters of the osteosynthesis plate. The software application will determine a set of design and size parameters of all possible fixation plate configurations that record output measures of any of stress, strain, and displacement that are within a threshold set in accordance with safe implant functioning and adequate fracture healing. This iterative process is indicated in Boxes 37 to 42. The software designates the best choice of osteosynthesis plate from the set of possible plates determined to be within these safety guidelines as indicated in Box 43. For example, the best choice could be the least intrusive osteosynthesis plate configuration that will perform adequately according to the output measures. The intrusion of the fixation plate could, for example, be based on the volume of the fixation plate.”)
Claim 50. Schmitt teaches ([Par 14] “In some embodiments, the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” )
Fenick makes obvious further in response to determining that the surgical instrumentation data fits within the spatial constraints, ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: this method determines whether or not the instrument will fit, i.e. it determines if the instruments fit and if the instruments do not fit])
Boerjes makes obvious causing data ([Par 192] “Thus, for example, a user interface may provide a number interactive, three-dimensional tools such as markup tools that a dentist or other dental professional may use to measure, mark, annotate, or otherwise manipulate a digital model to evaluate suitability for subsequent processing and the creation of a physical dental object such as a restoration.” [Par 221] “The user interface may include interactive tools for virtually positioning orthodontic hardware and/or brackets for orthodontic hardware and/or alignment guides onto the three-dimensional representation 702 within the user interface 704”)
Lovald makes obvious data in the as-finalized form . ([Abstract] “An implant for osteosynthesis used in the stabilization of fractured bone of the mandible. … The plate design can be modified to accommodate patient anatomy depending on the type of bone it is designed to stabilize. Design and size parameters of the fixation plate can be customized to each individual patient using a customization software application to determine the least invasive fixation plate that will provide adequate functioning in stabilizing the bone fracture to a degree that will allow safe bone healing. The invention includes a method of design of osteosynthesis plates using shape optimization for different types and locations of fractures.” [Par 45] “The application performs a multiple of analyses varying design and size parameters of the osteosynthesis plate. The software application will determine a set of design and size parameters of all possible fixation plate configurations that record output measures of any of stress, strain, and displacement that are within a threshold set in accordance with safe implant functioning and adequate fracture healing. This iterative process is indicated in Boxes 37 to 42. The software designates the best choice of osteosynthesis plate from the set of possible plates determined to be within these safety guidelines as indicated in Box 43. For example, the best choice could be the least intrusive osteosynthesis plate configuration that will perform adequately according to the output measures. The intrusion of the fixation plate could, for example, be based on the volume of the fixation plate.”)
Claim 51. Schmitt teaches ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”) (a) implementing, by the processor, a change to at least one of: the one or more candidate surgical instruments, the at least one candidate dental implant, the virtual surgical guide, ([Par 83] “As shown, the processing unit 502 is connected to a WAN, disclosed herein as the Internet. Using the Internet, the processing unit 502 can communicate data, including .stl files showing modeled data for manufacture … Using the Internet, data may be sent from the processing unit 502 to the remote computer 520 or the manufacturing site 522. In one example, the remote computer may be a dentist's or other provider's computer. Using the remote computer, the provider may access the images on the processing unit 502 (or alternatively receive and store a local copy) and may modify or edit the images as desired. Once edits or modifications are made the revised data may be sent back to the processing unit 502, or alternatively, may be sent directly to the manufacturing site. Once the manufacturing site 522 receives the data, it may be used to program the computer controller manufacturing machine 524 to create the intra oral devices.”)and at least one parameter for placement of the at least one candidate dental implant; and
(b) ([Par 80] “An exemplary system for performing the processes and methods described herein is shown in FIG. 18. FIG. 18 includes a computer system 500 including a processing unit 502 containing a processor 504 and a memory 506.”)([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.” [Par 70] “FIG. 11 illustrates the first drill guide 51 in use within the patient's mouth. The first drill guide 51 may be used to place two or more implants 42 and a central guide pin 54. First, the surgeon places the first drill guide 51 in the patient's mouth on the patient's posterior teeth and shapes the jaw bone until the guide 51 seats on the cusps of the posterior teeth. Next the metal tubes 52 in the guide 51 are used to drill holes in the jaw bone at the proper angulation and depth. Actual dental implants 42 may be placed in two or more of the drill sites.”) (ii)([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”)
Fenick makes obvious in response to determining that the surgical instrumentation data does not fit within the spatial constraints, ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: this method determines whether or not the instrument will fit, i.e. it determines if the instruments fit and if the instruments do not fit]) ([Col 7 line 26-32] “ In the event a patient's mouth is small and/or if there is insufficient head room for the surgeon to position the drill in the patient's mouth to align with the guide sleeve 28 in preparation for boring the fixture implant seat in the patient's jaw structure, the stent or casting 29 can be formed so as to permit the drill to be introduced sideways into the guide sleeve 28.” [Examiner’s note: this method determines whether or not the instrument will fit, i.e. it determines if the instruments fit and if the instruments do not fit])
The combination of Schmitt, Fenick, Boerjes, and Suryanarayanan does not explicitly teach iterating through processing steps until an end state is reached and finalizing data when that end state is reached
Lovald makes obvious iterating through processing steps until an end state is reached and finalizing data when that end state is reached ([Abstract] “An implant for osteosynthesis used in the stabilization of fractured bone of the mandible. … The plate design can be modified to accommodate patient anatomy depending on the type of bone it is designed to stabilize. Design and size parameters of the fixation plate can be customized to each individual patient using a customization software application to determine the least invasive fixation plate that will provide adequate functioning in stabilizing the bone fracture to a degree that will allow safe bone healing. The invention includes a method of design of osteosynthesis plates using shape optimization for different types and locations of fractures.” [Par 45] “The application performs a multiple of analyses varying design and size parameters of the osteosynthesis plate. The software application will determine a set of design and size parameters of all possible fixation plate configurations that record output measures of any of stress, strain, and displacement that are within a threshold set in accordance with safe implant functioning and adequate fracture healing. This iterative process is indicated in Boxes 37 to 42. The software designates the best choice of osteosynthesis plate from the set of possible plates determined to be within these safety guidelines as indicated in Box 43. For example, the best choice could be the least intrusive osteosynthesis plate configuration that will perform adequately according to the output measures. The intrusion of the fixation plate could, for example, be based on the volume of the fixation plate.”)
Lovald is analogous art because it is within the field of dental surgery. It would have been obvious to one of ordinary skill in the art to combine it with Schmitt, Fenick, Boerjes, and Suryanarayanan before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to optimize implantation. As noted by Lovald, while using software to plan dental surgery was known to the art, previous attempts did not effectively handle selection and optimization of the implants themselves ([Par 9] “U.S. Pat. No. 6,711,432 to Krause, et al, issued Mar. 23, 2004 describes the devices and methods for implementing computer aided surgical procedures and more specifically devices and methods for implementing a computer-aided orthopedic surgery utilizing intra-operative feedback. A three-dimensional model of an area of a patient upon which a surgical procedure is to be performed is modeled using software techniques. The software model is used to generate a surgical plan, including placement of multifunctional markers, for performing the surgical procedure. After the markers are placed on the patient, an updated image of the patient is taken and used to calculate a final surgical plan for performing the remainder of the surgical procedure. The three-dimensional modeling, surgical planning, and surgery may all take place remote from each other. … The problem with this method is that the software does not output any information as to the appropriate implant to use for the surgery nor does it output any information pertaining to the design parameters of an implant that would provide the best functioning for each patient. In the case of osteosynthesis, software of this nature should provide information describing design characteristics for an implant that will provide an environment for adequate fracture healing in each patient.”) To this end, Lovald presents a method for geometric optimization of the implants themselves to best suit a patient’s needs ([Abstract] “The plate design can be modified to accommodate patient anatomy depending on the type of bone it is designed to stabilize. Design and size parameters of the fixation plate can be customized to each individual patient using a customization software application to determine the least invasive fixation plate that will provide adequate functioning in stabilizing the bone fracture to a degree that will allow safe bone healing. The invention includes a method of design of osteosynthesis plates using shape optimization for different types and locations of fractures.” [Par 11] “The object of this invention is to create a plate of an optimal structure for osteosynthesis in that the implant provides maximal stability across the bone fracture while remaining minimally intrusive upon the patient. The design of the implant is done through shape optimization using a finite element or other mathematical solver. Size and shape parameters of each osteosynthesis plate can be customized to ensure adequate functionality and minimal invasiveness to each patient.”) Overall, one of ordinary skill in the art would have recognized that combining Lovald with Schmitt, Fenick, Boerjes, and Suryanarayanan would result in a system that allowed dynamic selection and generation of dental implants that were better suited to each patient.
Claim 53. Schmitt teaches wherein modifying the digital surgical plan includes one or more of: ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”)
selecting at least one alternative dental implant to replace the at least one candidate dental implant for use in the digital surgical plan;
adjusting placement coordinates of the at least one candidate dental implant in the digital surgical plan;
adjusting placement angles of the at least one candidate dental implant in the digital surgical plan;
selecting at least one alternative surgical instrument to replace at least one of the one or more candidate surgical instruments for use in the digital surgical plan; and
altering ([Par 83] “As shown, the processing unit 502 is connected to a WAN, disclosed herein as the Internet. Using the Internet, the processing unit 502 can communicate data, including .stl files showing modeled data for manufacture … Using the Internet, data may be sent from the processing unit 502 to the remote computer 520 or the manufacturing site 522. In one example, the remote computer may be a dentist's or other provider's computer. Using the remote computer, the provider may access the images on the processing unit 502 (or alternatively receive and store a local copy) and may modify or edit the images as desired. Once edits or modifications are made the revised data may be sent back to the processing unit 502, or alternatively, may be sent directly to the manufacturing site. Once the manufacturing site 522 receives the data, it may be used to program the computer controller manufacturing machine 524 to create the intra oral devices.”)for use in the digital surgical plan. ([Par 14] “the exemplary methods and systems disclosed herein provide a method for the restorative dentist, surgeon and laboratory to communicate and change if needed, the actual 3D virtual plan for any given patient via the Internet.”)
Lovald makes obvious altering one or more dimensions of a dental apparatus ([Par 4] “The osteosynthesis plate was designed to provide maximal stability over a bone fracture with a minimum of material and intrusion to the patient. The size of the shape of the fixation plate can be customized for each patient using a software application.” [Par 11] “The object of this invention is to create a plate of an optimal structure for osteosynthesis in that the implant provides maximal stability across the bone fracture while remaining minimally intrusive upon the patient. The design of the implant is done through shape optimization using a finite element or other mathematical solver. Size and shape parameters of each osteosynthesis plate can be customized to ensure adequate functionality and minimal invasiveness to each patient.”)
Allowable Subject Matter
Additionally, Claim 52 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in a way that overcomes the previously outlined rejections under 35 U.S.C. 101 and 112
Claim 52 would be allowed under 35 U.S.C. 103 over prior art. The following is a statement of reasons for the indication of allowable subject matter: prior art representative of the claim, in particular determining that a tool does not fit in a mouth when the mouth is large enough to accommodate the tool.
It should be noted again, however, that there are significant issues with this claim stemming from it a) seeming lacking support and b) seeming to contradict the accepted meaning of the term “exceeds.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael P Mirabito whose telephone number is (703)756-1494. The examiner can normally be reached M-F 10:30 am - 6:30 pm.
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/M.P.M./ Examiner, Art Unit 2187
/EMERSON C PUENTE/ Supervisory Patent Examiner, Art Unit 2187
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