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 .
Priority
This application is a national stage entry under 35 USC 371 OF PCT/US2022/022960 filed 31 March 2022 which claims the benefit of domestic priority from US Provisional Application no. 63/168,911 filed 31 March 2021.
Election/Restrictions
Applicant’s election without traverse of Invention I pertaining to claims 1-12 in the reply filed on 2 December 2025 is acknowledged.
Claims 13-18 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply.
Claim Objections
Claim1 line 12 is objected to because of the following informalities: item (iii) is considered to be (iv). Appropriate correction is required.
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.
Claim 1 recites the limitation "optical head" in line 4. There is insufficient antecedent basis for this limitation in the claim. The recitation of “optical head” is inconsistent with the “optical unit” recited in line 3.
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.
Claim(s) 1-3 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leung et al. (WO 2011/134083) in view of Hummelink (NL 2012416), further in view of Sohlden et al. (US Publication no. 2013/0318009).
In regard to claim 1, Leung et al. disclose a guidance system 100 for targeted interventions using medical instruments (page 13, under system overview with respect to figure 1a) comprising:
an optical unit 20 having first and second cameras 12 and a projector 15 disposed between the first and second cameras (see figures 1B, page 18 referring to figure 18), said optical head 20 being positioned such that a desired area of intervention defined by plurality of multi modal markers is within a field of view (page 18-19, can use fiducial markers);
a control unit 3 having a screen display 4, said control unit 3 communicatively coupled with said optical unit 20 and configured to receive a real time image of the area of intervention (page 51, under continuous system operation, system 100 provides continuously updated surgical guidance feedback in real time, also see page 27 system 100 provides a dynamically updated surgical plan that is registered to the patient anatomy in real-time),
Leung et al. does not teach that control unit 3 being configured to:
(i) receive MRI volume representations of the desired area of intervention,
(ii) register multi modal markers that appear in the field of view, (iii) generate guidance feedback images comprising a plurality of image elements based on the MRI volume representations and the real time image responsive to multi modal marker registration and
(iii) to transmit the guidance feedback images to the projector; the projector directing at least one of the guidance feedback image elements onto the area of intervention responsive to receipt of the guidance feedback images from said control unit.
Hummelink describes an anatomical projection system for providing surgical guidance feedback comprising a camera and projector is a projection system 1, the system 1 with a control unit 14 configured to:
(i) receive MRI volume representations of the desired area of intervention (preoperative images from MRI of an anatomical field of interest), page 7 lines 3-23), (ii) register multi modal markers (intraoperative position markers 10 registered with pre-operative markers 4) that appear in the field of view, (iii) generate guidance feedback images comprising a plurality of image elements based on the MRI volume representations and the real time image responsive to multi modal marker registration (reliable feedback is provided to the surgeon, the intraoperative markers 10 serving as real time image) and (iii) to transmit the guidance feedback images to the projector (page 8 lines 30-34, the projection system 1 of the invention is therefore capable of providing an accurate projected image appearing without visible visual delay between detection and projection; this is “real-time image projection”);
the projector directing at least one of the guidance feedback image elements onto the area of intervention responsive to receipt of the guidance feedback images from said control unit (page 8 lines 20-25 and page 8 line 30 – page 9 line 2, reliable feedback is provided to the surgeon, the intraoperative markers 10 serving as real time image, and the projection system 1 of the invention is therefore capable of providing an accurate projected image appearing without visible visual delay between detection and projection).
Modification of Leung et al. to implement a technique on its control unit 3 using it optical unit 20 is considered to have been obvious to one of ordinary skill in the art as the application of a known technique (that of Hummelink) to a known device (Leung et al.) to yield an improvement (e.g., improved image capturing from combined two cameras and projector, as well as providing for real time display of registered images). Neither Leung et al. nor Hummelink provide a touch screen display with the control unit. Sohlden et al. describes a system for surgical guidance feedback for planning a surgical path. Sohlden et al. teach that such a system can includes an input device such as touch screen display as part of workstation 40. Workstation 40 is considered similar to workstation 7 comprising control unit 3 of Leung et al. and modification of the screen display 4 to be a touch screen is considered to have been obvious to one of ordinary skill in the art in view of Sohlden et al. to allow a user to provide input or revision to operations of the control unit. In regard to claim 2, Leung et al. teach that control unit 3 displays a desired instrument entry point and a target on the MRI volume representation of the intervention area responsive to user selection (page 27, the surgical plan may include surgical criteria that can be displayed on the co-registered image. Examples of criteria that the surgeon may input into system 100, as part of a surgical plan, include, but are not limited to: the accepted accuracy of screw placement; the coordinates of the point of entry into the vertebrae 23 that define the principal axis 26; the accepted angle of screw placement; and the depth of screw placement).
In regard to claim 3, Leung et al. teach that the guidance feedback image includes a first image element representing a point of entry for the medical instrument, a second image element representing an orientation of the medical instrument and a third image element representing a distance to the target (page 27, features of feedback displayed include the accepted accuracy of screw placement; the coordinates of the point of entry into the vertebrae 23 that define the principle axis 26; the accepted angle of screw placement; and the depth of screw placement which are considered the same as claimed). In regard to claim 9, in Leung et al. the one or more of the guidance feedback image elements are displayed on the touch screen (page 36, the preoperative plan and surface topology image dataset for the vertebrae along with the planned pedicle screw orientation are then displayed on display 4, as shown in Figure 6(a). The surgeon can then proceed to begin the surgical procedure based on the information displayed). The screen 4 of Leung et al. considered modifiable into a touch screen based on Sohlden et al. In regard to claim 10, Leung et al. teach that the real time image of the area of intervention is displayed on the touch screen (page 27, Intraoperative image updates of the vertebrae 23 can be provided continuously or discretely according to input into the system 100 by, for example, a surgeon… the updated plan is provided on the display). In regard to claim 11, Leung et al. teach that the optical head 20 includes a mounting arm 375 (figure 25).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leung et al. (WO 2011/134083) in view of Hummelink (NL 2012416), and Sohlden et al. (US Publication no. 2013/0318009), further in view of Dempsey (US Publication no. 2012/0165652).
In regard to claim 12, Neither Leung et al. nor Hummelink nor Sohlden et al. discuss compatibility with MRI systems. Dempsey depicts in figure 15 a robotic surgical device situated between MRI components 280a and 280b. Dempsey teaches that the device located therein should preferably be capable of operating within a magnetic resonance imaging (MRI) scanner for the purpose of performing or assisting in image-guided interventions (para 133). As devices described in Leung et al., Hummelink or Sohlden et al. may be employed intraoperatively within MRI field locations, it is considered that the modification of the construction of the optical unit in Leung et al. to be compatible within MRI systems is considered obvious to one of ordinary skill in the art since Dempsey explicitly teach that equipment located near MRI must be suitable for operating in such environments to promote safety among professional staff and the patient.
Allowable Subject Matter
Claims 4-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach the images projected onto the intervention site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 3 March 2026