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 11-12, 14-20, 23 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 11 recites both “a tracker arm” and “a connecting arm”. These appear to be referencing the same structure (particularly reference number 24 in the present invention), and if this is the case they should be changed for clarity to have a single name. Additionally, the “tracker arm” is listed as another component than the “tracker arm mount”, however the “connecting arm” is defined as part of the “tracker arm mount”. Therefore it would be unclear how an arm could be both separate from and part of the mount.
Claim 20 recites “a tracker arm and a tracker arm mount” and that “the tracker arm mount comprising a threaded portion for receiving an optical tracking device”, however the drawings appear to show the threaded portion on the tracker arm away from the tracker arm mount. It is therefore unclear where the threaded portion is supposed to be located.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 11-12, 14-16, 20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Palmer (US20190223988) in view of Merritt (US20160074129).
Regarding claims 11 & 20, Palmer teaches a dynamic navigation system for oral and maxillofacial surgery, comprising: a tracker arm mount and a foundation guide (20, examiner has interpreted the “tracker arm mount and the foundation guide” to be a singular element with the foundation guide being a part of the tracker arm mount’s intended use as evidenced by paragraph [0054] & [0056] of the subjection specification); [a] body (20) comprising a top surface (22) and an inner surface (21) corresponding with an outer surface contour of a jaw bone (Palmer Figure 2; paragraph [0094]), a plurality of receiving slots (24), and a plurality of apertures (23) (Palmer Figure 2; paragraph [0094]); the apertures (23) adapted to receive a fastener for attachment of the tracker arm mount to the jawbone (Palmer Figure 2; paragraph [0094]); via these apertures, the tracker arm may be directly affixed to the jawbone via the tracker arm mount. With respect to claims 11, 20, and 23, the fastener is not positively recited as part of the invention and Palmer is capable of being used with a screw/fastener that could engage the full thickness of a jawbone.
Palmer remains silent on a tracker arm; the tracker arm mount comprising a threaded portion attached by a connecting arm to the body, and the threaded portion being configured to connect to an optical tracking device.
Merritt teaches an image guidance system for tracking surgical instruments during procedure, such as dental implant placements (Merritt paragraph [0042]). Merritt specifically discloses a tracker arm (104); the tracker arm mount comprising a threaded portion (118) attached by a connecting arm (104) to a body (102) that mounts the tracker arm for use in oral surgery (Merritt Figure 5; paragraph [0050] - [0052]). Merritt further discloses the threaded portion (118) being configured to connect to an optical tracking device (208) (Merritt Figure 4; paragraph [0053] [0054]). Merritt teaches that because the oral cavity is small, it is difficult to navigate and perform solely visual surgeries; however, optical tracking and image guided methods overcome many of the issues associated with visual dental surgery such as limited mouth opening space, prefabricated guides, and the inability to easily change plans (Merritt paragraph [0003], [0004], [0007], [0009]).
Palmer and Merritt are both considered analogous to the claimed invention because they are in the same field of dental implant guides. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Palmer to include a tracker arm with a threaded portion and optical tracking device coupled to the body as taught by Merritt, as the result of such modification would be an optical tracking device that can be used during image guided surgery for placement of implants and is attached to the tracker mount via a tracker arm ([0007] for instance).
With respect to the newly amended language of the tracker arm mount configured to face in a direction and be positioned on the body in a location optimized for a procedure based on a surgery treatment plan, see 112 rejection above, and additionally these seem to be product-by-process where only the resulting structure of a tracker arm mount facing a direction and having a position that allows the device to be used. The threaded portion being configured to connect to an optical tracking device is met by the threading in the prior art since it is capable of such use. The body configured in the same manner as the arm to optimize is rejected similarly. The fastener having a length and girth to engage the jaw adequately is the purpose of such fasteners in the prior art, and see 112 rejection above. The aperture and fastener configuration addressed similarly to the above.
Regarding claim 12, Palmer in view of Merritt teaches the dynamic navigation system of claim 11, and further discloses a dental device (10) comprising a plurality of tabs (11), the tabs corresponding to the receiving slots (24) in the body (20) for connecting the dental device to the body (Palmer Figures 1, 2, & 4; paragraph [0093][0094]).
Regarding claim 14, Palmer in view of Merritt teaches the dynamic navigation system of claim 12, and further discloses wherein the dental device comprises an occlusal positioning device (10) comprising a prosthesis having negative tooth impressions (17); the tabs (11) extending outward, for connection to the receiving slots; the occlusal positioning device having an undersurface (17); the undersurface comprising contours corresponding with a top surface of a patient's teeth (Palmer Figure 1; paragraph [0093]).
Regarding claim 15, Palmer in view of Merritt teaches the dynamic navigation system of claim 14 and further discloses wherein the occlusal positioning device (10) further comprises a plurality of verification window apertures (16); the verification window apertures disposed in the occlusal positioning device to ensure proper seating of the occlusal positioning device on the patient's teeth (Palmer Figure 1; paragraph [0093]).
Regarding claim 16, Palmer in view of Merritt teaches the dynamic navigation system of claim 15, and further discloses wherein the tabs (11,11A) are insertable into the corresponding receiving slots (24) via a pin (92) to join the body and the dental device and to seat the dental device onto the patient's teeth; the patient's teeth being partially viewable through the verification window apertures (16) to confirm a predetermined position (Palmer Figure 1, 2, 4, 4A; paragraph [0093], [0094], [0096]) .
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer in view of Merritt and further in view of Panchal et al (Dynamic Navigation for Dental Implant Surgery NPL).
Regarding claims 17 & 18, Palmer in view of Merritt teaches the dynamic navigation system of claim 16, and the combination further teaches a patient tracker (208) (Merritt Figure 4; paragraph [0053][0054]), an instrument tracker (306) (Merritt Figure 9; paragraph [0059]) , at least one camera (800), and a dynamic navigation unit (810) (Merritt Figure 14;paragraph [0084]);
wherein the tracker arm mount (20 of Palmer) is fixated to the jawbone and the tracker arm (104 of Merritt) is secured onto the tracker arm mount; the patient tracker and the instrument tracker in data communication with the at least one camera to generate camera data (Merritt paragraph [0084]); the camera data configured to transmit the camera data to a dynamic navigation unit (Merritt paragraph [0084]).
However, they remain silent on an ultraviolet light source, the ultraviolet light source is reflected off of the patient tracker and the instrument tracker, the camera being a stereotactic camera, and a monitor in data communication with a processor of the dynamic navigation system; the monitor configured to display the camera data.
Panchal teaches a dynamic navigation system for dental implant surgery. Panchal specifically discloses the system containing an ultraviolet light source (LED, all LEDS emit some form of UV light), a patient tracker (tracking array), instrument tracker (tracking array), and stereotactic camera (Panchal Figure 1; page 540-541, Dynamic Navigation Technology subheading). Panchal further discloses that the ultraviolet light source is the ultraviolet light source is reflected off of the patient tracker and the instrument tracker, and a monitor in data communication with a processor of the dynamic navigation system; the monitor configured to display the camera data (Panchal; page 540-541, Dynamic Navigation Technology).
Palmer, Merritt, and Panchal are both considered analogous to the claimed invention because they are in the same field of dental implant guides. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify Palmer and Merritt to include an ultraviolet light source, stereotactic camera, and monitor as taught by Panchal, as the result of such a modification would be the addition of known dynamic navigation features that aid in the calculation of positions of the patient and instruments.
Regarding claim 19, Palmer, Merritt, and Panchal teaches the dynamic navigation system of claim 17, and further discloses wherein the tracker arm mount is based on one of an intra oral scan or a digital tooth impression (Palmer paragraph [0094], [0104]); and having a guide tube (23) for accepting a fixation screw to provide anchorage into the underlying jawbone (Palmer Figure 2; paragraph [0094]).
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
The arguments appear to be repeated from the previous action without addressing the previous response, and will be addressed as best understood.
Applicant again appears to be arguing the references individually, such as Palmer not being dynamic which is taught by the inclusion of Merritt, and Merritt not having the custom fit to the jaw which is taught by the inclusion of Palmer. Both providing benefits to the combination as detailed in the rejection. It is unclear how many of the present arguments are related to the claimed structure and the prior art.
Applicant appears to be arguing “teaching away”, however this is when a reference specifically states something can or should not be done, which does not appear to be the case with the present rejection. Applicant also appears to be arguing “impermissible hindsight”, however motivation from the references have been provided to arrive at the combinations.
Applicant argues that Palmer does not provide space for the placement of a tracker arm of Merritt, however the ends of Palmer for instance are of a similar size to the device of Merritt and it is therefore unclear why this combination could not be made. Applicant also states that incorporating Merritt would require a redesign of the device and render many elements obsolete, but has not provided any examples of which elements would be obsolete and what would need to be redesigned other than simply the combination as addressed in the rejection above.
Applicant also argues that Merritt is specifically designed to attach to at least one tooth and therefore would not be combinable with Palmer. However, [0091] of Merritt for instance discusses direct attachment to the jawbone as an alternative to attachment to a tooth. Therefore this would not require a redesign and this would not have been outside the level of ordinary skill in the art at such time.
Applicant also appears to be arguing some of the intended use of the device, and even if the intended use of the device is different (such as regards to dynamic), only the resulting structure is at issue. Presently the claims are broader than what is argued in some of the response, particularly with respect to not positively recited fasteners in the claims. It is suggested to present amendments and arguments that address the structure of the device and how it structurally differentiates from the prior art in order to overcome the present rejection, such as inclusion of the fastener that attaches the tracker arm to the jawbone by engaging the full thickness of the jawbone when in use.
Response to Amendment
The affidavit under 37 CFR 1.132 filed is insufficient to overcome the rejection of the claims as set forth in the last Office action because: The arguments (11 and 12 for instance in the affidavit) therein rely upon the device of Merritt requiring mounting on a tooth, however this is not the case as discussed in [0091] for instance of Merritt that the device can be attached directly to the jaw bone.
With respect to sections 13-15, while these results are indicative of the invention and its possible novelty, the claims are presently quite broad compared to the invention of the specification. As previously suggested, further defining of the invention structurally would be beneficial in overcoming the prior art. An interview may be helpful in discussing possible changes.
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