DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of invention I and species 2 in the reply filed on 7/27/26 is acknowledged. Claims 5-6, 8, and 15-16 are directed to the non-elected invention and species, and thus withdrawn from examination. Accordingly, claims 1-4, 7, and 9-14, which encompasses the elected species, are under examination.
Claim Objections
Claim 10 is objected to because of the following informalities: In claim 10, the limitation "displaying a simulated image of an anatomical structure" should be modified to read "the displaying the simulated image of the anatomical structure". Appropriate correction is required.
Specification Objections
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Drawing Objections
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim 2-3 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 2 recites the limitation “the imaging instrument” which lacks sufficient antecedent basis in the claims. Furthermore, it is unclear whether this “imaging instrument” is referring to the “instrument” of claim 1 or another separate instrument not previously identified in the claims. Claim 3, which depends from claim 2, is rejected under the same grounds.
Claim Rejections – 35 USC 102 (AIA )
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2019/0380780 A1 to SELA.
Regarding claim 1, SELA teaches A system (Abstract: training system for training a trainee to perform a surgical procedure on an anatomical region) comprising: an anatomical model (Abstract: a physical model of the anatomical region; par. 0045: physical model or phantom of an anatomical region); a camera configured to image the anatomical model (par. 0032: optical tracking camera; par. 0061: video camera that provides a real-time stream of video showing the portion of the physical model 902 upon which the surgical procedure is being performed to the computer system 904); an instrument (Abstract: a physical training instrument); and a controller operably coupled to the camera and the instrument, the controller comprising a processor and a memory (Abstract: a computer system; par. 0032: Optical tracking systems; par. 0036: control and processing system 300 may include one or more processors 302, a memory 304; par. 0060: The tracking system 903 tracks the position and orientation of the physical training instrument 901 relative to the physical model 902 as the trainee manipulates the physical training instrument 901 to perform the surgical procedure), the memory having computer-executable instructions stored thereon (par. 0076: A programmable processor is adapted to execute software, which is typically stored in a computer-readable memory) that, when executed by the processor, cause the controller to: receive an image from the camera; determine, based on the image, a position of the instrument relative to the anatomic model (Abstract: computer system receives from the tracking system information indicating the location and orientation of the physical training instrument; par. 0034: These optical tracking systems also require a reference to the patient to know where the instrument is relative to the target … of the medical procedure; par. 0060: The tracking system 903 provides the position and orientation of the physical training instrument 901 to the computer system 904 in real-time as the (simulated) surgical procedure is performed; par. 0061: the tracking system 903 may provide images showing the physical model as the procedure progresses); and display a simulated image of an anatomical structure based on the position of the instrument relative to the anatomical model (Abstract: a display device… computer system receives from the tracking system information indicating the location and orientation of the physical training instrument and generates and displays an augmented physical model and the physical training instrument…display is updated based as the trainee manipulates the physical training instrument; par. 0062: computer system 904 receives the tracking system information and, based on that information, generates and displays on the display device 905 a display showing an augmented physical model and a depiction of the physical training instrument 901; par. 0063: augmented physical model 902 is generated by the computer system 905 based on images of the physical model 902 upon which the surgical procedure is being performed with virtual elements rendered by the computer system and superimposed on a digital rendering of the physical model 902 derived from the video images received from the tracking system 903).
Regarding claim 9, SELA further teaches wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the controller to: determine an orientation of the instrument relative to the anatomic model, and wherein the simulated image of the anatomical structure is based on the position and orientation of the instrument relative to the anatomical model (par. 0060: tracking system 903 tracks the position and orientation of the physical training instrument 901 relative to the physical model 902 as the trainee manipulates the physical training instrument 901 to perform the surgical procedure; par. 0062: computer system 904 receives the tracking system information and, based on that information, generates and displays on the display device 905 a display showing an augmented physical model and a depiction of the physical training instrument 901).
Claim Rejections - 35 USC § 103 (AIA )
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2, 4, and 7 is/are rejected under 35 U.S.C. 103 as being obvious over SELA, as applied to claim 1, in view of US 2021/0059755 A1 to VILLAIN and US 5,704,791 to GILLIO.
Regarding claim 2, SELA further teaches a marker, and wherein determining a position comprises determining a position relative to a marker (par. 0034: optical tracking system knows the position in space of a tip of a medical instrument relative to the tracking markers being tracked; par. 0044: active tracking markers)), but does not disclose wherein the anatomical model comprises a marker, and wherein determining the position of the imaging instrument comprises determining the position of the imaging instrument relative to the marker.
Regarding claim 4, SELA teaches the elements above, including that aspects of the present disclosure may be applied to any suitable medical procedure (par. 0043), but does not disclose wherein the anatomic model comprises a model of an esophagus.
Regarding claim 7, SELA teaches the elements, including that disclose “surgical tool” or “surgical instrument” refers to any item that may be directed to a site along a path in the patient's body (par. 0026), but does not disclose wherein the instrument comprises a model of an endoscope.
However, VILLAIN teaches a tracking device configured to track a position of a physical representation of an interventional tool with respect to the physical model of the anatomical structure (Abstract) wherein the anatomical model comprises a marker, and wherein determining the position of the … instrument comprises determining the position of the … instrument relative to the marker (par. 0035: Tracking a position of the physical representation of the interventional tool and the physical model of the anatomical structure…may refer to tracking a refer to a relative position, i.e. a position of the physical representation of the interventional tool with respect to the physical model of the anatomical structure; par. 0036: the physical model of the anatomical structure may comprise a marker). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the manner of tracking a physical model of an anatomical structure and medical instrument using markers, as taught by VILLAIN, into the invention of SELA, in order to apply a known technique for tracking physical models relative to each other to similar devices, thereby achieving a predictable result. Although SELA and VILLAIN do not expressly describe the instrument as an imaging instrument or wherein the instrument comprises a model of an endoscope or wherein the anatomic model comprises a model of an esophagus, GILLIO also teaches that it is well known to use a simulated endoscope that corresponds to an actual endoscope in a simulated system in order to simulate an endoscopic technique (col. 4, lines 18-20; col. 6, line 66-col. 7, line 2; col. 15, lines 23-34). GILLIO further teaches the simulated system includes a simulated anatomy including an esophagus (col. 7, lines 20-36). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a simulated endoscope and simulated esophagus, as taught by GILLIO, as the simulated instrument and simulated model in the modified invention of SELA, in order to better prepare physicians for specific medical procedures using specific simulated instruments and anatomical structures.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being obvious over SELA in view of VILLAIN and GILLIO, as applied to claim 2, in further view of US 2017/0200383 A1 to ROMERO.
Regarding claim 3, SELA teaches the elements above, including the use of markers (par. 0034; 0044), but does not disclose wherein the marker comprises a binary identifier. However, ROMERO teaches a system that uses markers to determine locations wherein the marker comprises a binary identifier (par. 0027-0028: binary markers, each marker is associated with a binary number). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the binary markers, each marker associated with a binary number, as taught by ROMERO, into the invention of SELA, in order to use a known type of marker for determining location of an object, thereby achieving a predictable result.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being obvious over SELA, as applied to claim 1, in view of WO 2006/023224 A2 to GRUENBAUM.
Regarding claim 10, SELA teaches the elements above, but does not disclose wherein displaying a simulated image of an anatomical structure comprises displaying a frame of a video of a non-simulated procedure.
Regarding claim 11, SELA teaches the elements above, but does not disclose wherein the video of the non-simulated procedure comprises a plurality of frames, and wherein each of the plurality of frames is annotated with a position of the frame in the non-simulated procedure.
However, GRUENBAUM teaches a system for simulating a medical procedure (Abstract) wherein displaying a simulated image of an anatomical structure comprises displaying a frame of a video of a non-simulated procedure (FIG. 5A, ref. 508; par. 0067: a window 502, of a graphical user interface, contains a digital image 508 of an open area of a living being's anatomy) and wherein the video of the non-simulated procedure comprises a plurality of frames, and wherein each of the plurality of frames is annotated with a position of the frame in the non-simulated procedure (FIG. 5A, ref. 510; par. 0067: As described above, a medical procedure can be divided into a series of steps and moves, where a medical procedure such as the "Modified Pelvic Lymph Node Dissection" is made up of a series of steps and each step has one or more moves associated therewith. Fields within the window 502 provide feedback to a user and indicate the particular place within the medical procedure that the digital image 508 represents, such as Step 1 at 504 and Move 1 at 506). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the actual images and step information displayed in a medical simulation system, as taught by GRUENBAUM, into the invention of SELA, in order to provide a more realistic training experience while informing the user of their current step in series of steps defining a medical procedure.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being obvious over SELA, as applied to claim 1, in view of WO 99/42978 to PLAYTER.
Regarding claim 12, SELA teaches the elements above, but does not disclose wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the controller to: display an instruction to position the instrument at a predetermined location relative to the anatomical model.
Regarding claim 13, SELA teaches the elements above, but does not disclose wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the controller to: detect that the instrument is positioned at the predetermined location of the anatomical model.
Regarding claim 14, SELA teaches the elements above, but does not disclose displaying an indication that the instrument is positioned at the predetermined location of the anatomical model.
However, PLAYTER teaches a related surgical simulation system (Abstract) configured to display an instruction to position the instrument at a predetermined location relative to the anatomical model, detect that the instrument is positioned at the predetermined location of the anatomical model, and displaying an indication that the instrument is positioned at the predetermined location of the anatomical model (pg. 14, lines 19-29: surgical skill evaluation module 64…that performs a surgical skill evaluation process 61 for measuring, recording, evaluating and reporting the surgical performance of the user of the simulated surgical procedure. In particular, the measured surgical tool positions…that occur during the simulated surgical procedure are monitored by this module and recorded (Step 63) in a programmable storage media associated with the system 10 of the invention. The stored information is used by the surgical skill evaluation module for determining and providing a raw score of the user's performance (Step 65) based on physical data such as, for example…position…information of the simulated surgical tools; pg. 17, line 31-pg. 18, line 14: user is asked to touch certain target objects in the knee with the surgical tool, the position and orientation of the tool is measured and compared to the preferred tool position to determine an overall target distance error). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the functionality of asking a user to touch certain target objects in the anatomical model, measure the position of the surgical instrument during the simulated procedure, and provide a raw score that indicates a distance error between the actual tool position and the preferred tool position, as taught by PLAYTER, into the invention of SELA, in order to provide a known manner of evaluating surgical instrument accuracy for requested target positions in a simulated anatomical environment, thereby teaching the user where improvement of their surgical instrument placement is needed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715
