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 .
Response to Amendment
The amendment filed August 6, 2025 has been entered. Claims 1-7, 9-17, and 19-21 remain pending in the application. Claims 1 11, and 21 are noted as amended.
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.
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.
Claims 1-4, 6-7, 9, 11-14, 16-17, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque (US PGPub 20180286287) in view of Tepper et al. (US PGPub 20140011173), hereinafter referred to as Tepper, and Patil et al. (US PGPub 20220087644), hereinafter referred to as Patil.
In regards to claims 1, 11, and 21, Razzaque teaches a computer-implemented method [claim 1], a system [claim 11], and a computer program product [claim 21] for generating a simulated medical image (Abstract; Paragraphs 0045, 0054 teaches the system generates simulated images on the display for a surgical procedure) of a manikin part for a user performing a simulated surgical procedure (Abstract; Paragraphs 0050, 0054 teach the system includes a phantom (manikin) which can be shaped to simulate anatomical features/organs), comprising:
a processor; and a non-transitory computer readable storage medium comprising instructions stored thereon; the processor, upon execution of the instructions (Paragraphs 0018, 0042-0043; processor and storage media), being configured to perform the method comprising:
receiving a tip position of a tip of a medical tool in a reference coordinate system, the tip of the medical tool being inserted into the manikin part (Paragraphs 0037-0038, 0051, 0055, 0063, 0069 teach the system detects the position and orientation of the probe and ultrasound wand including the tip of the probe/tool based on the EM sensors and other tracking sensors within a coordinate frame of reference);
receiving an actual position of a virtual medical probe in the reference coordinate system (Paragraphs 0037, 0051, 0062 teach the system detects the position and orientation of the probe and ultrasound wand including the position of the wand within a coordinate frame of reference), the virtual medical probe having a predefined virtual field of view associated thereto (Paragraphs 0046, 0059, 0062 teach the system generates the image (view) based on the position and pose of the wand);
generating a simulated medical image of the manikin part based on the position of the virtual medical probe (Fig. 4; Paragraphs 0054, 0063), the simulated medical image comprising a representation of the tip of the medical tool and a representation of a region of the manikin part surrounding the tip of the medical tool (Fig. 4, Paragraphs 0054); and
providing the simulated medical image for display (Paragraphs 0045, 0054 teach the system can display the simulated images/video).
Razzaque may not explicitly teach based on the tip position and the actual position of the virtual medical probe, determining that the predefined virtual field of view does not intersect the tip position of the tip of the medical tool; determining a further position for the virtual medical probe in the reference coordinate system until the predefined virtual field of view intersects the tip position of the tip of the medical tool when the virtual medical probe is positioned at the further position; and generating the image based on the further position of the virtual medical probe. However, Tepper teaches a system and method for training in ultrasound guided procedures including evaluating a user’s performance based on the captured ultrasound images including determining if a needle tip is not visible and adjusting the image by repositioning the wand/transducer brings the tip into view wherein the system can provide feedback including guidance on position and orientation of the wand (Tepper Paragraphs 0091, 0097, 0146, 0203, 0236, 0349). Tepper may not explicitly teach the guidance being to adjust the wand to a position to intersect the view with the needle tip. However, Patil similarly teaches methods and systems for user guidance in an ultrasound imaging system including providing guidance to adjust a position of an ultrasound probe to achieve a target scan plane or bring a target feature into view (Paragraphs 0019, 0126).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Razzaque to incorporate the teachings of Tepper and Patil by incorporating the steps of determining a needle/tip of an instrument is not visible/in view of the image and determining a target view/image from the wand including intersecting a needle tip of Tepper and providing guidance to the user to position and angle the wand to achieve the image including the tip of the needle/instrument of Tepper and Patil for the training and procedures of Razzaque, as the references and the claimed invention are directed to ultrasound procedure training/evaluation systems including detecting the relative positions of tools and anatomical structures and providing feedback/guidance to the user. One of ordinary skill in the art would modify Razzaque by coding the system to include determining if the tip of the tool/needle/probe is not in view of the ultrasound wand based on the position of the tip of the tool/probe, determining a position and angle to adjust the ultrasound wand to view the needle tip thereby intersecting the field of view of the probe with the needle tip, and guiding the user to reposition the wand to the new position to achieve the desired view thereby generating the corresponding view in the “further position”. Upon such modification, the method and system of Razzaque would include based on the tip position and the actual position of the virtual medical probe, determining that the predefined virtual field of view does not intersect the tip position of the tip of the medical tool; determining a further position for the virtual medical probe in the reference coordinate system until the predefined virtual field of view intersects the tip position of the tip of the medical tool when the virtual medical probe is positioned at the further position; and generating the image based on the further position of the virtual medical probe. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Tepper and Patil with Razzaque’s system and method in order to evaluate user ultrasound positioning and provide guidance to improve user performance.
In regards to claims 2 and 12, Razzaque further teaches wherein said determining the desirable position comprises:
determining whether the virtual field of view intersects the tip of the tool when the virtual medical probe is in the standard position (Paragraphs 0054-0055 teaches the images are generated based on the pose and position of the probe, wand, and phantom and the system can determine if the tip of the probe is in position relative to a target location within the surgical view); and
when the virtual field of view does not intersect the tip of the tool, performing one of: determining an acceptable deviation from the standard position so that the virtual field of view intersects the tip of the tool (Paragraph 0055 teaches the system determines if the probe is in the correct position and can superimpose the position onto the 3D model if the gap is small (acceptable deviation) or provide an error if the gap is too large), wherein the acceptable deviation from the standard position defines the desirable position (Paragraph 0055; superimposing the position onto the model); and
determining a further standard position for the virtual medical probe corresponding to the procedural step (Paragraphs 0063, 0069 teaches the system continuously updates the display including navigational aids as the procedure progresses (further standard/target positions)), wherein said determining the desirable position is performed using the further standard position as the starting position (Paragraphs 0055, 0069).
In regards to claims 3 and 13, Razzaque further teaches wherein said initiation of the procedural step comprises detecting one of a user indication (Paragraph 0063; “input by the clinician to initiate the beginning of, or end, the delivery of ablative energy”), a procedural action (Paragraphs 0063, 0068; “the clinician begins the simulated surgical procedure by advancing the simulated ablation probe”) and a change of position of the medical tool (Paragraph 0068; “the clinician begins the simulated surgical procedure by advancing the simulated ablation probe”).
In regards to claims 4 and 14, Razzaque further teaches wherein the procedural action comprises one of an activation of a built-in function on the medical tool (Paragraph 0063; “input by the clinician to initiate the beginning of, or end, the delivery of ablative energy” and “turning on and off the simulated ablation probe”).
In regards to claims 6 and 16, Razzaque further teaches wherein said detecting the initiation of the procedural step comprises receiving a user input identifying the procedural step (Paragraph 0063 teaches the clinician may input information received from the probe at the target location (completion of step/identifying the step) and/or select a power setting or other ablation setting to begin or end delivery of the ablative energy).
In regards to claims 7 and 17, Razzaque further teaches wherein the virtual medical probe comprises a virtual ultrasound probe (Paragraphs 0040, 0054; “ultrasound wand”), the virtual field of view of the virtual medical probe comprises a virtual ultrasound beam emitted by the virtual ultrasound probe (Paragraphs 0040, 0054 teaches the images are generated based in part on the pose and position of the ultrasound wand), and the simulated medical image comprises a simulated ultrasound image (Paragraph 0054; simulates ultrasound images).
In regards to claims 9 and 19, Razzaque further teaches wherein said determining the desirable position for the virtual ultrasound probe comprises at least one of determining desirable position coordinates for a reference point located on the virtual ultrasound probe (Paragraphs 0055, 0063; target location/region) and determining a desirable orientation of the virtual ultrasound probe (Paragraphs 0037, 0054, 0062 teach the system determines/detects the position and orientation (pose) of the ultrasound probe).
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque in view of Tepper and Patil, as applied to claims 1 and 11 above, and further in view of Cinquin et al. (US PGPub 20110046476), hereinafter referred to as Cinquin.
In regards to claims 5 and 15, Razzaque in view of Tepper and Patil may not explicitly teach wherein said determining the standard position comprises: accessing a database containing a list of predefined procedural steps each being associated with at least one respective standard position for the virtual medical probe; and retrieving from the database the standard position corresponding to the current procedural step. However, Cinquin teaches a system and method for analyzing a surgical operation for training purposes by detecting a position of a tool and organ and determining the position of the tool relative to the organ wherein the system includes a database of conceptual surgery protocols and steps including the defined (standard) position of the tools in order to determine a deviation between the conceptual operation and the user’s actual operation/actions (Abstract; Paragraphs 0065-0066, 0070, 0118).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Razzaque in view of Tepper and Patil to incorporate the teachings of Cinquin by incorporating the procedure/conceptual database of Cinquin for the training and procedures of Razzaque, as both references and the claimed invention are directed to surgical training/evaluation systems including detecting the relative positions of tools and anatomical structures. One of ordinary skill in the art would modify Razzaque in view of Tepper and Patil by coding the system to include a database of relevant surgical procedures including the related surgical steps and associating the target positions of Razzaque with the stored procedures and steps. Thereby, the continuous monitoring and guidance of Razzaque would be based on the retrieved procedure/conceptual steps including standard positions for the tools and probes. Upon such modification, the method and system of Razzaque in view of Tepper and Patil would include wherein said determining the standard position comprises: accessing a database containing a list of predefined procedural steps each being associated with at least one respective standard position for the virtual medical probe; and retrieving from the database the standard position corresponding to the current procedural step. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Cinquin with Razzaque in view of Tepper and Patil’s system and method in order to improve surgeon training by providing comprehensive guidance and evaluation for each step of surgical procedures and for a variety of surgical operations (Cinquin Paragraphs 0063, 0065).
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque in view of Tepper and Patil, as applied to claims 1 and 11 above, and further in view of Henschel et al. (US PGPub 20110046476), hereinafter referred to as Henschel.
In regards to claims 10 and 20, Razzaque in view of Tepper and Patil may not explicitly teach wherein the virtual medical probe comprises one of a virtual arthroscope and a virtual laparoscope. However, Henschel teaches a system and method for mixed reality simulation of laparoscopic surgical procedures including using an anatomical model and laparoscope (Abstract; Paragraphs 0050, 0052).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Razzaque in view of Tepper and Patil to incorporate the teachings of Henschel by substituting the laparoscope and corresponding procedures of Henschel for the ablation probe and ultrasound wound of Razzaque, as both references and the claimed invention are directed to surgical training/evaluation systems for minimally invasive surgeries using simulated images/video and an anatomical model/mannequin. One of ordinary skill in the art would modify Razzaque in view of Tepper and Patil by coding the system to include laparoscopic imaging and procedures and substituting the laparoscope and corresponding model of Henschel for the phantom and tools of Razzaque. Further, Razzaque does teach the images of the system can be generated to emulate laparoscopic imaging (Razzaque paragraph 0035). Upon such modification, the method and system of Razzaque in view of Tepper and Patil would include wherein the virtual medical probe comprises one of a virtual laparoscope. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Henschel with Razzaque in view of Tepper and Patil’s system and method in order to provide comprehensive surgical training and improve the learning experience by increasing realism (Henschel paragraph 0007).
Response to Arguments
Applicant’s arguments, see Remarks, filed August 6, 2025, with respect to the 35 U.S.C. rejection(s) of claims 1-7, 9-17, and 19-21 have been fully considered and are persuasive. The rejection(s) of claims 1-7, 9-17, and 19-21 under 35 U.S.C. 101 has been withdrawn.
Applicant’s arguments, see Remarks, filed August 6, 2025, with respect to the rejection(s) of claim(s) 1-7, 9-17, and 19-21 under 35 U.S.C. 102 and 103 have been fully considered and are persuasive by virtue of Applicant’s amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 in view of the newly cited combination of prior art discussed above.
Conclusion
Accordingly, claims 1-7, 9-17, and 19-21 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached on (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CORRELL T FRENCH/Examiner, Art Unit 3715
/KANG HU/Supervisory Patent Examiner, Art Unit 3715