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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 The previous rejections of claims 30-31 and 34 under 112 has been withdrawn.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 b