DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Responsive to the communication dated 05/18/2026
Claims 21-22, 29-31, 38-39, 41-47, 49, and 52-62 are presented for examination
Finality
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Response to Arguments – Claim Objections
Applicant’s arguments, see page 17, filed 05/18/2026, with respect to the previous objections to claims 21-22, 29-31, 38-39, 41-47, 49, and 52-53 have been fully considered and are persuasive. The previous objections to claims 21-22, 29-31, 38-39, 41-47, 49, and 52-53 have been withdrawn.
However, it should be noted that the substantial new amendments have introduced several new issues; see the Claim Objection section below.
Response to Arguments - 35 USC § 112
Applicant’s arguments, see page 17-18, filed 05/18/2026, with respect to the previous rejection of claims 21-22, 29-31, 38-39, 41-47, 49, and 52-53 under 35 USC § 112 have been fully considered and are persuasive. The previous rejection of claims 21-22, 29-31, 38-39, 41-47, 49, and 52-53 under 35 USC § 112 has been withdrawn.
However, it should be noted that the substantial new amendments have introduced several new issues under 112; see the 112 rejection section below.
Response to Arguments - 35 USC § 101
Applicant’s arguments, see pages 18-22, filed 05/18/2026, with respect to the rejection of claims 21-22, 29-31, 38-39, 41-47, 49, and 52-53 under 35 USC § 101 have been fully considered and are persuasive. The rejection of claims 21-22, 29-31, 38-39, 41-47, 49, and 52-53 under 35 USC § 101 has been withdrawn.
Particularly, the specific series of 3D scanning, scan merging, and iterative surgical plan development and refinement to design and fabricate a physical surgical guide uniquely generated for a specific procedure, alongside corresponding tool and implant geometry optimization, successfully integrates the claims into a practical application.
Response to Arguments- 35 USC § 103
Applicant’s arguments, see pages 23-28, filed 05/18/2026, with respect to the rejection of claims 21-22, 29-31, 38-39, 41-47, 49, and 52-53 under 35 USC § 103 have been fully considered and are persuasive. The rejection of claims 21-22, 29-31, 38-39, 41-47, 49, and 52-53 under 35 USC § 103 has been withdrawn.
Particularly, no prior art nor combination of references that would have been reasonable for one of ordinary skill in the art to combine was found that teaches: “obtaining, by a processor and from a memory device accessible by a dental virtual modeling application and operably coupled to the processor, scan data including: first scan data of a surgical region of the patient's upper or lower jaw, and second scan data of an opposing jaw region obtained while the patient's mouth is in a selected open position; importing, by the processor, the scan data from the memory device into the dental virtual modeling application running on a workstation computer; developing, by the processor, a three-dimensional (3D) virtual model of the patient's oral cavity within the dental virtual modeling application, wherein developing the virtual model comprises merging the first scan data and the second scan data to generate a unitary virtual model that represents the surgical region and the opposing jaw region for the patient's mouth in the selected open position; computing, by the processor, spatial constraint data relating to spatial constraints of the patient's open mouth based on the first scan data and the second scan data; determining, by the processor and based on the first scan data and the second scan data, a height dimension in the virtual model between a top surface of a virtual surgical guide placed in the surgical region and the opposing jaw region wherein the height dimension corresponds to a candidate implant axis for placement of at least one candidate dental implant;… generating, by the processor, a virtual representation of the candidate instrumentation aligned with the candidate implant axis in the virtual model for display on an electronic display device operably coupled to the processor in a human-readable format to one or more users responsible for placement of at least one dental implant in the patient's open mouth; performing, by the processor, a collision check between the virtual representation of the candidate instrumentation and the opposing jaw region in the unitary virtual model to determine whether the candidate instrumentation is predicted to encounter a spatial limitation during placement of the at least one dental implant, wherein performing the collision check comprises generating a prediction of whether the candidate instrumentation will fit in the patient's open mouth based on a comparison of the height dimension and the dimensional data for the candidate instrumentation;”
Examiner’s Note
The following sections include several suggested amendments. As the content of the claims between the claim 21, 30, and 38 claim branches are substantially similar, recommended language is given in reference to the claim 21 branch version, or the claim 30 branch version if it differs significantly from the corresponding claim 21 branch language, unless otherwise noted. Please ensure that the language differences between the claims are preserved when making amendments (e.g. if the amendment example given is to change “obtaining” to “getting” in claim 21, in claim 30 “obtain” should be changed to “get” and similarly for claim 38.
Claim Objections
Claims 21-22, 29-31, 38-39, 41-47, 49, and 52-62 are objected to because of the following informalities:
Claims 21 and 30 recite “at least one alternation to the digital surgical plan… based on the at least one alternative…” The use of “alternation” and “alternative” are interpreted as being typographical errors and are both meant to read “alteration.” While amending these to read “alteration” would overcome this objection, it should be noted that significant issues with support exist for these limitations; see the 112 rejection section below.
Claim 38 recites “at least one alternation to the digital surgical plan… based on the at least one alteration…” The use of “alternation” is interpreted as being a typographical error and are meant to read “alteration.” While amending this to read “alteration” would overcome this objection, it should be noted that significant issues with support exist for these limitations; see the 112 rejection section below.
Claim 44 recites “… further comprising generating, by the processor using the digital surgical plan and the 3D virtual model the virtual surgical guide…” It is recommended to add a comma between “model” and “the” i.e. “… further comprising generating, by the processor using the digital surgical plan and the 3D virtual model, the virtual surgical guide…” It should be noted that other issues are present with this claim that require correction; see the 112 rejection section below.
Claim 45 recites “the manufacturer…” As no manufacturer was previously introduced, it is recommended to replace “the manufacturer…” with “a manufacturer…” to avoid potential issues with antecedent basis.
Claim 53 recites “… candidate instrumentation…” As the candidate instrumentation was previously introduced, it is recommended to amend the claim to instead read “… the candidate instrumentation…” to avoid potential issues with antecedent basis. It should be noted that other issues are present with this claim that require correction; see the 112 rejection section below.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 29-31, 38-39, 41-47, 49, and 52-62 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.
In particular, Claims 21, 30, and 38 recite “first scan data of a surgical region of the patient's upper or lower jaw, and second scan data of an opposing jaw region…” While support does appear to exist for a first scan of just the surgical region followed by a second scan, then merging the two scans, there does not appear to be support for the second scan to only contain the opposing jaw region; what appears in the specification seems to only give support for the second scan being a scan of the entire mouth, i.e. both jaw regions ([Par 27] “FIG. 2 illustrates a second scan 20 of the patient's mouth with the mouth in the opened position. Bite blocks may be used to assist the patient in holding his or her mouth in the opened position. If the patient is wearing a removable denture in the jaw opposing the implant-receiving region, then they would remove it during the second scan 20.” [Par 49] “At step 302, a CT scan is taken of the region in the patient's mouth that will receive the dental implants. At step 304, a CT scan is taken of the patient's mouth in the opened position. Next, at step 306, the data from the CT scans at step 302 and 304 is then imported into computer modeling software and used to develop a 3-D virtual model of the patient's mouth. The data from the CT scans at step 302 and 304 is then merged, via a shape- matching algorithm to develop a unitary virtual model. The shape-matching algorithm, as is commonly known in CAD/CAM and scanning systems, utilizes common features (e.g., bone, markers, teeth, scanning appliances, etc.) in the two scans to locate the relative position of one set of data to the other set of data.”)
As the second scan does include the opposing jaw region but is not exclusively limited to it, it is therefore suggested to amend the claims to instead read “first scan data of a surgical region of the patient's upper or lower jaw, and second scan data that includes an opposing jaw region…”
Claims 21, 30, and 38 recite “…the dental virtual modeling application running on a workstation computer” There does not appear to be any disclosure of the use of a “workstation” computer specifically. See the specification at ([Par 49] “Next, at step 306, the data from the CT scans at step 302 and 304 is then imported into computer modeling software and used to develop a 3-D virtual model of the patient's mouth.”)
As such, it is recommended to remove the word “workstation” and amend the claims to instead read “…the dental virtual modeling application running on a
Claims 21, 30, and 38 recite “… providing, by the processor and based on the prediction of whether the candidate instrumentation will fit in the patient's open mouth, human- readable guidance information for display on the electronic display device to the one or more users, wherein the guidance information includes at least one recommended alteration of a digital surgical plan including altering a selection of at least one of: the at least one candidate dental implant, a planned implant location, a design or dimensions of the virtual surgical guide, a design or dimensions of the candidate instrumentation; implementing, by the processor, at least one alternation to the digital surgical plan in accordance with a selection by the one or more users in accordance with the guidance information;” Based on a review of the disclosure, providing this information as guidance information does not seem to have support, with the disclosure merely describing implementing one of these changes, not providing them visually first; see ([Par 30] “If the height dimension H3 is less than the length of the instrumentation necessary to complete the implant installation on the virtual model, then alterations must be made to be surgical plan so that the instrumentation will fit within the patient's mouth at each surgical location. Examples of such alterations may include (i) changes to the size of the implant or the implant mount, (ii) changes to the location (e.g., angular orientation and/or position) of the implant in the bone, (iii) changes to the surgical guide, and/or (iv) changes to the instrumentation that is to be used for a certain implant.”)
Further, support for modifying “a design or dimensions” of the candidate instrumentation does not appear in the disclosure, with the most specific example of alterations to the instrumentation disclosed merely being “changes” to said instrumentation ([Par 50] “Based on the data from the second CT scan of step 304, the instrumentation suggested for use in accordance with the surgical plan can be compared against the available dimensions within the patient's mouth. Thus, at step 308, the dimensions of the instrumentation suggested for use with each implant in the surgical plan (according to system parameters) are compared against the available dimensions to ensure that there will be no spatial problems encountered in the patient's mouth. Accordingly, at step 310, if spatial problems are encountered, the surgical plan must be altered to ensure that no spatial problems will be encountered during the actual surgery in the patient's mouth. As such, at step 312, for any implant that has encountered a problem, the alterations related to the implant or the suggested instrumentation can occur. Examples of such alterations may include (i) changes to the size of the implant or the implant mount, (ii) changes to the location (e.g., angular orientation and/or position) of the implant in the bone, (iii) changes to the surgical guide, and/or (iv) changes to the instrumentation that is to be used for a certain implant.”)
Additionally, it is recommended to amend “at least one alternation” to instead read “at least one alteration” as “alternation” is believed to be a typographic error.
As such, it is recommended to amend the claims to remove this guidance step and instead just implement the change, such as in the following: “… comprising: altering at least one candidate dental implant, a planned implant location, , a design or dimensions of the virtual surgical guide, and altering the candidate instrumentation;
In accordance with this change, “the at least one alternative” referred to in the following limitation in claims 21 and 30 should be amended to instead read “the at least one alteration”
Due to these changes it is also recommended to amend dependent claims to remove references to this guidance information (e.g. for claim 53, change “…further comprising modifying the digital surgical plan in accordance with the guidance information by…” to “change “…further comprising modifying the digital surgical plan
Claims 21 recites “…an as-altered digital surgical plan having the at least one alteration for provision as human- readable information to the one or more users as a finalized digital surgical plan…” while claims 30 and 38 recite “… finalizing an as-altered digital surgical plan having the at least one alteration for display on the electronic display device to the one or more users in the human-readable format; providing, based on the prediction, a finalized digital surgical plan as human-readable information for display on the electronic display device to the one or more users;” There does not seem to be any support for displaying or otherwise providing “as human-readable information” the finalized plan to a user, with the disclosure only describing sending the finalized plan for manufacturing after generating it ([Par 10-11] “After the checking step, the method includes obtaining final surgical-guide manufacturing information based on the virtual model, and manufacturing the surgical guide based on the final surgical-model manufacturing information. … 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, obtaining final surgical-guide manufacturing information based on the virtual model after the altering, and manufacturing the surgical guide based on the final surgical-model manufacturing information.” [Fig. 11])
As such it is recommended to amend claim 21 to read “thereafter, finalizing, by the processor, an as-altered digital surgical plan having the at least one alteration
Similarly, it is recommended to amend claims 30 and 30 to read “provide, based on the prediction, a finalized digital surgical plan
fabricate, based on data representative of at least a portion of the finalized digital surgical plan, the virtual surgical guide as an actual surgical guide for use in an actual clinical setting by the one or more users for placing the at least one dental implant in the surgical region using the actual surgical guide and actual instrumentation.”
Claim 44 recites “generating, by the processor, using the digital surgical plan and the 3D virtual model the virtual surgical guide on the electronic display device to the one or more users.” As mentioned above, while use of the surgical plan is described, any display or presentation of the plan appears to lack support. See the specification at ([Par 10-11] “After the checking step, the method includes obtaining final surgical-guide manufacturing information based on the virtual model, and manufacturing the surgical guide based on the final surgical-model manufacturing information. … 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, obtaining final surgical-guide manufacturing information based on the virtual model after the altering, and manufacturing the surgical guide based on the final surgical-model manufacturing information.” [Fig. 11])
It is recommended to amend claim 44 to read “…generating, by the processor, using the digital surgical plan and the 3D virtual model, the virtual surgical guide.
Claim 47 recites “…further comprising causing, by the processor, the digital surgical plan to be output in a human-readable format.” As mentioned above, while use of the surgical plan is described, any display or presentation of the plan appears to lack support. See the specification at ([Par 10-11] “After the checking step, the method includes obtaining final surgical-guide manufacturing information based on the virtual model, and manufacturing the surgical guide based on the final surgical-model manufacturing information. … 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, obtaining final surgical-guide manufacturing information based on the virtual model after the altering, and manufacturing the surgical guide based on the final surgical-model manufacturing information.” [Fig. 11])
It is recommended to cancel claim 47, as once the unsupported content is removed, the remaining claim scope is already captured in claim 21 (i.e. “outputting” the plan without necessarily displaying it)
Claim 53 recites “selecting at least one alternative dental implant to replace the at least one candidate dental implant for use in the digital surgical plan; … selecting at least one alternative instrument to replace candidate instrumentation for use in the digital surgical plan; …” There appears to be a lack of support for changes to the dental implant and instrumentation specifically involving selection of alternatives; the specification only describes changes of size for the implant and generic “changes” for the instrumentation. ([Par 50] “Examples of such alterations may include (i) changes to the size of the implant or the implant mount, (ii) changes to the location (e.g., angular orientation and/or position) of the implant in the bone, (iii) changes to the surgical guide, and/or (iv) changes to the instrumentation that is to be used for a certain implant”)
To remove the unsupported limitations, it is recommended to amend the claim to instead read "changing the at least one candidate dental implant for use in the digital surgical plan; … changing the candidate instrumentation for use in the digital surgical plan; …”
Claim 55 recites “causing, by the processor, the electronic display device to display the guidance information in the human-readable format to the one or more users.” As mentioned above, displaying such displaying of any kind of “guidance information” beyond the virtual surgical guide itself does not appear to be supported by the disclosure. ([Par 10-11] “After the checking step, the method includes obtaining final surgical-guide manufacturing information based on the virtual model, and manufacturing the surgical guide based on the final surgical-model manufacturing information. … 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, obtaining final surgical-guide manufacturing information based on the virtual model after the altering, and manufacturing the surgical guide based on the final surgical-model manufacturing information.” [Fig. 11])
As such, it is recommended to amend claim 55 to instead read “causing, by the processor, the electronic display device to display the virtual surgical guide in the human-readable format to the one or more users.”
Claim 56 recites “… comprising causing, by the processor, the electronic display device to display the as-altered digital surgical plan in the human- readable format to the one or more users.” As mentioned above, displaying the surgical plan does not appear to be supported by the disclosure. ([Par 10-11] “After the checking step, the method includes obtaining final surgical-guide manufacturing information based on the virtual model, and manufacturing the surgical guide based on the final surgical-model manufacturing information. … 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, obtaining final surgical-guide manufacturing information based on the virtual model after the altering, and manufacturing the surgical guide based on the final surgical-model manufacturing information.” [Fig. 11])
Claim 57 recites “… further comprising causing, by the processor, the electronic display device to display the finalized digital surgical plan in the human- readable format to the one or more users.” As mentioned above, displaying the surgical plan does not appear to be supported by the disclosure. ([Par 10-11] “After the checking step, the method includes obtaining final surgical-guide manufacturing information based on the virtual model, and manufacturing the surgical guide based on the final surgical-model manufacturing information. … 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, obtaining final surgical-guide manufacturing information based on the virtual model after the altering, and manufacturing the surgical guide based on the final surgical-model manufacturing information.” [Fig. 11])
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emerson Puente can be reached at (571) 272-3652. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.P.M./Examiner, Art Unit 2187
/EMERSON C PUENTE/Supervisory Patent Examiner, Art Unit 2187
Prosecution Insights