DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 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.
Claim 1 recites the limitation "the teeth" in line 13. Claim 6 recites “the tops” in line 1. Claim 7 recites “the attachments” in line 4. Claim 11 recites “the teeth” in line 13. Claim 13 recites “the tops” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “performing a reflection of a gum tissue of the patient”. It is unclear what “performing a reflection” would entail and additionally it is unclear how this is related to the remainder of the method. Claim 1 also recites “attaching the tracker arm mount”, however no tracker arm mount has been fabricated, nor is it clear what this is being attached to. Claim 1 further recites “accurately repositioning the tracker arm mount”, however, as stated above, this has not been fabricated and is only virtually designed. Claim 1 also recites designing of a “foundation guide”, however it is unclear how this would be different from “a tracker arm mount” and how the “foundation guide” is related to the rest of the structure since there are no further references to this structure. Claim 1 additionally recites “a tracker arm” in both line 1 and line 6, making it unclear if these are the same or different tracker arms.
Claim 2 recites “attaching the prosthesis to the tracker arm mount”, and again the tracker arm mount has not been fabricated and is only virtual.
Claim 4 recites “designing a prosthesis”, which is unclear as to whether this is the same or a different prosthesis as that already recited.
Claim 6 is unclear if the structure is virtual or physical since the dental implants have only been established as virtual, but seem to be being used with physical structure.
Claim 8 recites “reinserting the prosthesis”, which is unclear since there does not appear to be a removal from insertion step of the prothesis itself or clarity on where it would be reinserted. Claim 8 also recites “attaching the prosthesis into the dental implants”. It is again unclear what is physical and what is virtual and how they can be interfaced with one another, in addition to how the prosthesis could be attached “into” dental implants.
Claim 9 recites “optical tracking device”, which is unclear if this is the same or a different tracking device from that of claim 1.
Claim 10 recites “a patient surface generation”, however it is unclear what this would be referring to in the method and does not appear to be mentioned in the specification.
Method claims 11-15 are rejected for the same reasons where they overlap.
Claim 17 recites “the fabrication”, however there appears to be two recitations of fabrication in claim 11 and it is unclear which this limitation is referring to, or possibly both.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-17 are rejected as best understood under 35 U.S.C. 103 as being unpatentable over Palmer (US 2019/0223988) in view of Merritt (US 2016/0074129).
Palmer shows a dynamic navigation method for oral and maxillofacial surgery using a tracker arm comprising: acquiring digital data associated with a patient ([0095] 3D image, scanned teeth model); generating a dental surgery treatment plan ([0002] placement of dental implants); placing a plurality of virtual dental implants ([0092],[0098] discusses placement of implants in regards to the computer software/”implant sites”); designing a tracker arm mount and a foundation guide based on the surgery treatment plan (see 112 above, tracker arm mount 20 with foundation guide which may refer to the portion of 20 engaging bone); designing a prosthesis (2’ for instance corresponds to such) and a positioning device for attaching the tracker arm mount to a jawbone of the patient (10 and 2’ function as such); fabricating the prosthesis and the tracker arm mount positioning device (fabricated by 3D printing for instance for carrying out the method of Palmer); performing a reflection of a gum tissue of the patient (see 112 above; this may refer to the scanning of the gum tissue which could be considered a reflection): attaching the tracker arm mount (such as shown in attached state of Fig. 4); attaching the tracker arm mount positioning device onto the teeth accurately repositioning the tracker arm mount with the positioning device (such as shown in Fig. 4). With respect to claim 2, further comprising removing the teeth; planing the jawbone (Fig. 11 shows the removal of teeth and planing); placing the dental implants using a dynamic navigation system in communication with the tracker arm (see below); and attaching the prosthesis to the tracker arm mount (see above). With respect to claim 3, wherein the step of data acquisition comprises acquiring photographic images, measurements, digital impressions, and 3D x-rays (CBCT) taken of the patient ([0012] discusses the combination of digital/laser scanning and CT imaging which would incorporate the above). With respect to claim, further comprising uploading the patient data acquired into CAD/CAM software (in order to 3D print); and designing a prosthesis (prosthesis 60). With respect to claim 5, wherein in response to designing the prosthesis: ensuring a position associated with the positioning device using dental implant treatment planning software provides an adequate amount of jawbone to support the prosthesis ([0042] discusses checking for adequacy of bone and [0092] is mindful of bone degradation). With respect to claim 6, further comprising attaching temporary cylinders into the tops of the dental implants ([0012] and [0101] for instance discusses cylinder placement). With respect to claim 7, further comprising luting the dental implants to the temporary cylinders with dental light cure composite material ([0012] discusses use of light or self-curing material with the cylinders); detaching the temporary cylinders and the prosthesis; removing the attachments and smoothing and polishing the prosthesis ([0012] discusses removal and polish/preparation of the prosthesis). With respect to claim 8, further comprising: removing the tracker arm mount; and reinserting the prosthesis; and attaching the prosthesis into the dental implants ([0089]/Fig. 3 shows the removed mount and attachment). With respect to claim 16, wherein the fabrication occurs through additive or subtractive manufacturing (3D printing).
However, Palmer fails to show a tracker arm and attaching an optical tracking device/bulb to the tracker arm mount and ensuring a clear field of view.
Merritt similarly teaches a dental implant placement method wherein a tracker arm (104) has a threaded portion (118) configured to connect to an optical tracking device (208) (Fig. 4; [0053],[0054]). With respect to claim 9, wherein optical tracking device is an optical tracking bulb ([0012] discusses optical transmitters that emit signals which is considered equivalent to an optical tracking bulb due to the emission of light/signals). With respect to claim 10, wherein the dental surgery treatment plan is based on a patient surface generation and an anticipated clear field of view of at least one stereotactic detection camera (see 112 above; [0084] discusses the placement of cameras for viewing and surface generation may be considered scan data). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Palmer’s method by including the arm, tracking device/bulb, and camera placement as taught by Merritt in order to allow for tracking during image guided surgery for further ensuring correct placement of implants (see also [0003]-[0004], [0007] and [0009]).
Method claims 11-15, 17 are rejected similarly to the above as they have the same limitations and also fabrication of the tracker arm, tracker arm mount, and foundation guide (shown by Palmer as detailed above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW NELSON whose telephone number is (571)270-5898. The examiner can normally be reached on Monday-Friday 7:30am-5:00pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eric Rosen, at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW M NELSON/Primary Examiner, Art Unit 3772
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