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
Applicant claims the benefit of US Provisional Application No. 63/314,573, filed 02/28/2022. Claims 1-22 have been afforded the benefit of this filing date.
Information Disclosure Statement
The IDS dated 11/28/2023, 04/13/2023, 11/25/2025, and 02/27/2026 has been considered and placed in the application file.
Amendment
Applicant submitted amendments on 02/27/2026. The Examiner acknowledges the amendment and has reviewed the claims accordingly.
Overview
Claims 1-22 are pending in this application and have been considered below.
Claim 21 is cancelled.
Claims 12 and 13 are objected to.
Claims 1-11, 14-20 and 22 are rejected.
Applicant Arguments:
In regards to the argument on Argument 1, Applicant/s state/s “The Office Action fails to identify disclosure in Wang of a camera sightline being different from a direction of X-ray travel, Thus, the Office Action fails to identify disclosure of the camera 1220 having a sightline different from a direction of X-ray travel, as opposed to different from Wang's lasers.” therefore, the rejection of claim 1 should be removed (See remarks, Pg 9, A).
In regards to the argument on Argument 2, Applicant/s state/s “Navab teaches away from modifying Navab's fusion of an X-ray image with optical images such that Navab's camera (as incorporated into Mata) would have a sightline different from the direction of X-ray travel.” therefore, the rejection of claim 1 should be removed (See remarks, Pg 9, B).
In regards to the argument on Argument 3, Applicant/s state/s “Modifying Navab's camera (as the Office Action proposes incorporating into Mata) would either render Navab's fusion of optical images with an X-ray image inoperable or require substantial redesign.” therefore, the rejection of claim 1 should be removed (See remarks, Pg 10, C).
In regards to the argument on Argument 4, Applicant/s state/s “The Office Action does not provide a credible rationale linking the alleged motivation to the alleged modification proposed by the Office Action to have x-rays emitted in a direction different from the camera sightline.” therefore, the rejection of claim 1 should be removed (See remarks, Pg 10, D).
In regards to the argument on Argument 5, Applicant/s state/s “the Office Action does not identify generating fluoroscopic images and generating video images, but rather identifies generating fluoroscopic images ( or static x-ray images) with the C-arm.” therefore, the rejection of claim 9 should be removed (See remarks, Pg 11, ¶06).
In regards to the argument on Argument 6, Applicant/s state/s “the Office Action has not established a credible rationale or motivation for a person of ordinary skill in the art to modify Mata's device to utilize a fluoroscopic stream of images in combination with a video stream. Instead, the disclosure of Navab cited by the Office Action teaches away from using more than a single X-ray image to avoid radiation, and thus teaches away from using a fluoroscopic stream of images when co-registering with a video stream of images.” therefore, the rejection of claim 9 should be removed (See remarks, Pg 11, ¶07).
In regards to the argument on Argument 7, Applicant/s state/s “The Office Action does not identify disclosure of a processor being configured to plot a reference axis extending centrally through Mata's locking hole in the manner recited in claim 14.” therefore, the rejection of claim 14 should be removed (See remarks, Pg 12, A).
In regards to the argument on Argument 8, Applicant/s state/s “Paragraph 50 of Mata, cited by the Office Action as disclosing a second stream of images along a second beam axis, does not actually disclose such in the manner recited in claim 14.” therefore, the rejection of claim 14 should be removed (See remarks, Pg 13, B).
In regards to the argument on Argument 9, Applicant/s state/s “The Office Action fails to identify a rationale for modifying Mata's device in view of Navab to include a robotic arm in the manner recited in claim 14.” therefore, the rejection of claim 14 should be removed (See remarks, Pg 13, C).
In regards to the argument on Argument 10, Applicant/s state/s “The Office Action cites Wang as disclosing an "anchor hole" but does not identify disclosure of such in Wang or a credible rationale/motivation for such modifying Mata (as modified by Navab).” therefore, the rejection of claim 14 should be removed (See remarks, Pg 13, D).
In regards to the argument on Argument 11, Applicant/s state/s “The Office Action does not identify disclosure of reference axis extending centrally through Mata's locking hole in the manner recited in claim 19.” therefore, the rejection of claim 19 should be removed (See remarks, Pg 14, A).
In regards to the argument on Argument 12, Applicant/s state/s “The Office Action does not provide a credible rationale linking the alleged motivation to the alleged modification proposed by the Office Action to generate a second stream of fluoroscopic images in Mata in the manner recited in claim 19.” therefore, the rejection of claim 19 should be removed (See remarks, Pg 15, B).
In regards to the argument on Argument 13, Applicant/s state/s “the Office Action has not identified disclosure that would actually lead a person of ordinary skill to modify Mata in view of Cohen to generate a second stream of fluoroscopic images substantially perpendicular to the alleged first stream of fluoroscopic images in the manner recited in claim 22.” therefore, claim 22 is allowable (See remarks, Pg 16, ¶05).
Examiner’s Responses:
In response to Arguments 1-6, Applicant’s arguments, see Remarks, filed 02/27/2026, have been considered but is moot in view of new ground(s) of rejection. A new reference, Holthuizen, has been introduced which teaches the main concept of Claims 1 and 9 in which a medical imaging system and method combines a video and x ray image together through registering a marker to create an image that details the inside and outside of a patient in real time. The Examiner interprets Holthuizen to teach amended independent claims 1 and 9 based on the reasoning outlined in the rejection below. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for claims 1-6, and 9 under 35 U.S.C. 102(a)(2) in view of Holthuizen et al (US Patent Publication US 2021/0052329 A1, hereafter referred to as Holthuizen).
In response to Arguments 7-12, Applicant’s arguments, see Remarks, filed 02/27/2026, have been considered but is moot in view of new ground(s) of rejection. Two new references, Finley and Gorek, have been introduced which teach the main concept of Claim 14, 19, and 22 in which a surgical system and surgical method use two different views from x ray scans to determine the implant and its positioning within the patient. The Examiner interprets Finley and Gorek to teach amended claim 14 and 19 and new claim 22 based on the reasoning outlined in the rejection below. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for claims 14, 19-20, and 22 under 35 U.S.C. 103 in view of Finley et al (US Patent Publication US 2023/0036038 A1, hereafter referred to as Finley) in view of Gorek (WO Patent Publication WO 2007136784 A2, hereafter referred to as Gorek).
Claim Interpretation
Under MPEP 2143.03, "All words in a claim must be considered in judging the
patentability of that claim against the prior art." In re Wilson, 424 F.2d 1382, 1385, 165 USPQ494, 496 (CCPA 1970). As a general matter, the grammar and ordinary meaning of terms as understood by one having ordinary skill in the art used in a claim will dictate whether, and to
what extent, the language limits the claim scope. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives, the prior art teaches the element if one of the alternatives is taught by the prior art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288,1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009).
Claim 11 recite “at least one of” then listing “fluoroscopic and video stream of images”. Since “at least one of” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 16 recite “at least one of” then listing “first and second streams of fluoroscopic images data”. Since “at least one of” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 17 recite “at least one of” then listing “first and second streams of fluoroscopic images data”. Since “at least one of” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
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, 4, 6, 7, 14, and 22 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 pre-AIA the applicant regards as the invention. The Examiner strongly suggested that appropriate corrections be made to clarify the claim scope.
With respect to Claim 1, the claim recites the following, each of which renders the claim indefinite:
“ substantially” on line 24 (unclear how this affects the scope of the claim, as “substantially” is not defined as a concrete value or definite amount in the specification, the specification mentions “substantially” in ¶0038, ¶0039, ¶0060, however in these paragraphs there is not concrete or definite explanation on how this affects the display, the parallel nature of the beam or the perpendicular nature of the beam);
With respect to Claim 4, the claim recites the following, each of which renders the claim indefinite:
“ substantially” on line 3 (unclear how this affects the scope of the claim, as “substantially” is not defined as a concrete value or definite amount in the specification, the specification mentions “substantially” in ¶0038, ¶0039, ¶0060, however in these paragraphs there is not concrete or definite explanation on how this affects the display, the parallel nature of the beam or the perpendicular nature of the beam);
With respect to Claim 6, the claim recites the following, each of which renders the claim indefinite:
“ substantially” on line 3 (unclear how this affects the scope of the claim, as “substantially” is not defined as a concrete value or definite amount in the specification, the specification mentions “substantially” in ¶0038, ¶0039, ¶0060, however in these paragraphs there is not concrete or definite explanation on how this affects the display, the parallel nature of the beam or the perpendicular nature of the beam);
With respect to Claim 7, the claim recites the following, each of which renders the claim indefinite:
“ substantially” on line 4 (unclear how this affects the scope of the claim, as “substantially” is not defined as a concrete value or definite amount in the specification, the specification mentions “substantially” in ¶0038, ¶0039, ¶0060, however in these paragraphs there is not concrete or definite explanation on how this affects the display, the parallel nature of the beam or the perpendicular nature of the beam);
With respect to Claim 14, the claim recites the following, each of which renders the claim indefinite:
“ substantially” on line 7 (unclear how this affects the scope of the claim, as “substantially” is not defined as a concrete value or definite amount in the specification, the specification mentions “substantially” in ¶0038, ¶0039, ¶0060, however in these paragraphs there is not concrete or definite explanation on how this affects the display, the parallel nature of the beam or the perpendicular nature of the beam);
With respect to Claim 22, the claim recites the following, each of which renders the claim indefinite:
“ substantially” on line 1 (unclear how this affects the scope of the claim, as “substantially” is not defined as a concrete value or definite amount in the specification, the specification mentions “substantially” in ¶0038, ¶0039, ¶0060, however in these paragraphs there is not concrete or definite explanation on how this affects the display, the parallel nature of the beam or the perpendicular nature of the beam);
Claim Rejections - 35 USC § 102
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 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.
Claims 1-6 and 9 are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Holthuizen et al (US Patent Publication US 2021/0052329 A1, hereafter referred to as Holthuizen).
Regarding Claim 1, Holthuizen discloses a medical imaging system (Holthuizen ¶0010, Fig 1 30 and 38, disclose a system including one or more imaging devices), comprising:
a robotic arm carrying a fluoroscopic imaging device having an x-ray emitter (Holthuizen ¶0036, ¶0038, Fig 1, 30 discloses a mobile c arm with an Xray device), wherein the fluoroscopic imaging device is configured to generate fluoroscopic image data of an anatomical structure along a beam axis (Holthuizen ¶0038 discloses the adaptation of the c arm to a viewing angle of the visualizations of internal structures of the patient, Fig 1 34 discloses the beam direction of the x ray device), the robotic arm being manipulatable for adjusting a relative position between the fluoroscopic imaging device and the anatomical structure (Holthuizen ¶0038 discloses the adaptation of the c arm to a viewing angle of the visualizations of internal structures of the patient);
a video imaging device configured to generate video image data of the anatomical structure (Holthuizen ¶0009, ¶0011, Fig 1, 38, and ¶0034 discloses a video camera attached to the c-arm to observe the surface of the patient) and along a camera sightline axis (Holthuizen Fig 1 38 discloses the camera and the sightline axis), wherein the x-ray emitter is configured to direct x-rays to the anatomical structure in a first direction (Holthuizen Fig 1 34 discloses the beam direction of the x ray device) , and wherein the camera sightline axis extends from the video imaging device to the anatomical structure in a second direction that is different from the first direction of x-ray travel of the x-rays that are emitted by the x-ray emitter (Holthuizen Fig 1 discloses the Xray 34 and the sightline of the x ray pointing one direction, while the video camera 38 and the video camera sightline is pointed a different direction, both capturing images from different sightlines);
a marker positioned with respect to the anatomical structure (Holthuizen ¶0037, ¶0044, ¶0046 discloses an imaging marker that is used to track the position of the patient), the marker defining at least one reference feature configured to be captured in the fluoroscopic image data and the video image data (Holthuizen ¶0037 discloses that the marker is used to determine the spatial relationship to the photodetectors allowing for the processing unit to combine a surface image of the patient with x-ray information from within the patient and all this with a synchronized viewing angle and with the video image in the same scale as the x-ray image);
a processor in communication with the fluoroscopic imaging device and the video imaging device (Holthuizen ¶0058, S8, and abstract discloses processing images of each object from different viewing angles) the processor further in communication with a memory having instructions stored therein (Holthuizen ¶0019 discloses the processing unit being part of a computer program product that is equipped to carry out procedural steps), wherein the processor is configured to execute the instructions upon the fluoroscopic image data and the video image data (Holthuizen ¶0037 discloses the processing unit to combine a surface image of the patient with x-ray information from within the patient and all this with a synchronized viewing angle and with the video image in the same scale as the x-ray image) and responsively:
register a reference position of the at least one reference feature (Holthuizen ¶0037 discloses registration and combination of x-ray images with video images may be the light detector of the main tracking system which may be positioned on the patient) the relative to the anatomical structure in the fluoroscopic image data and the video image data (Holthuizen ¶0037 discloses that the marker is used to determine the spatial relationship to the photodetectors allowing for the processing unit to combine a surface image of the patient with x-ray information from within the patient and all this with a synchronized viewing angle and with the video image in the same scale as the x-ray image); and
generate an augmented image stream that shows one of the fluoroscopic image data and the video image data overlaid onto the other of the fluoroscopic image data and the video image data (Holthuizen ¶0037 discloses that the marker is used to determine the spatial relationship to the photodetectors allowing for the processing unit to combine a surface image of the patient with x-ray information from within the patient and all this with a synchronized viewing angle and with the video image in the same scale as the x-ray image) such that the reference positions are co-registered (Holthuizen ¶0037 discloses registration and combination of x-ray images with video images may be the light detector of the main tracking system which may be positioned on the patient); and
a display in communication with the processor (Holthuizen Fig 1 discloses the processing unit 20 connected to the display 40), wherein the display is configured to present the augmented image stream of the anatomical structure substantially in real time (Holthuizen ¶0037 discloses that the marker is used to determine the spatial relationship to the photodetectors allowing for the processing unit to combine a surface image of the patient with x-ray information from within the patient and all this with a synchronized viewing angle and with the video image in the same scale as the x-ray image in real time and showing the combined image on the display).
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Regarding Claim 2, Holthuizen discloses the medical imaging system of claim 1, wherein the marker is positioned adjacent the anatomical structure at an ex vivo location (Holthuizen ¶0037 and Fig 1, 12 disclose the light detector that is used for the phot marker being placed on the outside of the patient).
Regarding Claim 3, Holthuizen discloses the medical imaging system of claim 2, wherein:
the fluoroscopic image data comprises a fluoroscopy stream (Holthuizen ¶0009 discloses the imaging device generating real time images of the interior of the patient) showing the anatomical structure and the marker (Holthuizen ¶0044 discloses the marker being viable in the x ray images of the patient),
the video image data comprises a video stream (Holthuizen ¶0037 discloses the video camera providing live images) showing the anatomical structure and the marker (Holthuizen ¶0044 discloses the marker being viable in the images of the patient), and
the augmented image stream comprises an adjusted version of the video stream superimposed with an adjusted version of the fluoroscopy stream (Holthuizen ¶0037 discloses the images being scaled) such that the marker occupies the same area in the superimposed adjusted versions of the video and fluoroscopy stream (Holthuizen ¶0037 discloses that the marker is used to determine the spatial relationship to the photodetectors allowing for the processing unit to combine a surface image of the patient with x-ray information from within the patient and all this with a synchronized viewing angle and with the video image in the same scale as the x-ray image in real time and showing the combined image on the display).
Regarding Claim 4, Holthuizen discloses the medical imaging system of claim 3, wherein the video imaging device is attached adjacent the x-ray emitter (Holthuizen Fig 1 shows the camera attached the arm with the x ray emitters) and a camera of the video imaging device is configured such that the sightline axis is substantially parallel to the beam axis (Holthuizen Fig 1 discloses the sightline access and the beam access of the camera being parallel to the same location the patient).
Regarding Claim 5, Holthuizen discloses the medical imaging system of claim 1, wherein the first direction is angularly offset from the second direction (Holthuizen Fig 1 shows the camera angle and the x ray angle intersecting at an angle) such that the video imaging device is configured to generate the video image data that captures the at least one reference feature at a first perspective (Holthuizen ¶0058 discloses the combination image showing the same viewing direction but different perspectives, such as the video showing the outer surface of a patient) and the fluoroscopic imaging device is configured to generate the fluoroscopic image data that captures the at least one reference feature at a second perspective that is different from the first perspective (Holthuizen ¶0058 discloses the combination image showing the same viewing direction but different perspectives, such as a 2d x ray projection).
Regarding Claim 6, Holthuizen discloses the medical imaging system of claim 3, further comprising an instrument having a distal tip configured to operate upon the anatomical structure (Holthuizen ¶0034, Fig 1 , 60 discloses an interventional instrument with a distal tip) , wherein the augmented image shows a substantially live stream of the distal tip positioned with respect to the anatomical structure (Holthuizen ¶0037 discloses that the marker is used to determine the spatial relationship to the photodetectors allowing for the processing unit to combine a surface image of the patient with x-ray information from within the patient and all this with a synchronized viewing angle and with the video image in the same scale as the x-ray image in real time and showing the combined image on the display) when the distal tip is within a field of view of the video stream (Holthuizen ¶0034, Fig 1 , 60 discloses an interventional instrument with a distal tip and a marker so that the spatial relationship of the instrument can be tracked).
Regarding Claim 9, Holthuizen discloses a method (Holthuizen ¶0020 discloses a method), comprising:
generating a fluoroscopic stream of images of an anatomical structure (Holthuizen ¶0009 discloses the imaging device generating real time images of the interior of the patient);
generating a video stream of images, with an optical video imaging device (Holthuizen ¶0037 discloses the video camera providing live images), of an exterior of the anatomical structure (Holthuizen 0034 discloses the video camera observing the surface of the patient);
co-registering the fluoroscopic stream of images with the video stream of images (Holthuizen ¶0037 discloses registration and combination of x-ray images with video images may be the light detector of the main tracking system which may be positioned on the patient); and
depicting, on a display, an augmented image stream that includes the co-registered fluoroscopic stream of images overlaid over the co-registered video stream of images (Holthuizen ¶0037 discloses that the marker is used to determine the spatial relationship to the photodetectors allowing for the processing unit to combine a surface image of the patient with x-ray information from within the patient and all this with a synchronized viewing angle and with the video image in the same scale as the x-ray image in real time and showing the combined image on the display).
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.
Claims 7-8 and 10-11 are rejected under 35 U.S.C. 103 as unpatentable over Holthuizen et al (US Patent Publication US 2021/0052329 A1, hereafter referred to as Holthuizen) in view of Mata et al (US Patent Publication 20190083178 A1, hereafter referred to as Mata).
Regarding Claim 7, Holthuizen teaches the medical imaging system of claim 6, and the video imaging device is a camera attached to the instrument such that that the camera sightline axis is substantially parallel to the instrument axis (Holthuizen Fig 1 discloses the camera being attached to the instrument and the sightline access and the beam access of the camera being parallel to the same location the patient).
Holthuizen does not explicitly disclose wherein the instrument has a handle portion, the distal tip extends from the handle portion along an instrument axis.
Mata is in the same field image analysis assisted procedure. Further, Mata teaches wherein the instrument has a handle portion (¶0008, Mata, "FIGS. 2A and 2B are perspectives view of the example surgical instrument assembly depicted in FIG. 1, which includes a display attached to a surgical instrument.") , the distal tip extends from the handle portion along an instrument axis (¶0038, Mata "that includes a proximal end 226b adjacent to the body 205 of the surgical instrument 203, and a cutting tip 226a").
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 the invention of Holthuizen by incorporating the operating instrument and surgical application that is taught by Mata, to make an invention that can practically apply the method of the dual view guided surgery; thus, one of ordinary skill in the art would be motivated to combine the references since an object of the present invention is to address the difficulty of properly align a drill bit to the axis of the distal locking hole due to lack of visibility while using radiographic images as disclosed by Mata in ¶0023.
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 8, Holthuizen in view of Mata teaches the medical imaging system of claim 7, wherein the instrument is a drill (¶0035, Mata "Further, though the surgical instrument 203 is depicted as a surgical drill for purposes of example,"), the distal tip is defined by a drill bit coupled to the drill (¶0038, Mata "the cutting instrument 226 is a drill bit, and the cutting tip 226a is a tip of the drill bit,"), and the adjusted version of the fluoroscopy stream in the augmented image (Holthuizen ¶0037 discloses that the marker is used to determine the spatial relationship to the photodetectors allowing for the processing unit to combine a surface image of the patient with x-ray information from within the patient and all this with a synchronized viewing angle and with the video image in the same scale as the x-ray image in real time and showing the combined image on the display) shows an implant inserted within the anatomical structure (¶0040, Mata "the target locations 126 can be defined by an implant 125, for instance an IM nail or rod, in a bone."). See Claim 7 for rationale, its parent claim.
Regarding Claim 10, Holthuizen teaches the method of claim 9, wherein the fluoroscopic stream of images (Holthuizen ¶0009 discloses the imaging device generating real time images of the interior of the patient).
Holthuizen does not explicitly disclose depicts an implant residing in the anatomical structure.
Mata is in the same field image analysis assisted procedure. Further, Mata teaches depicts an implant residing in the anatomical structure (Mata ¶0041 discloses display the example fluoroscopic image, of the implant in the anatomical structure).
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 the invention of Holthuizen by incorporating the operating instrument and surgical application that is taught by Mata, to make an invention that can practically apply the method of the dual view guided surgery; thus, one of ordinary skill in the art would be motivated to combine the references since an object of the present invention is to address the difficulty of properly align a drill bit to the axis of the distal locking hole due to lack of visibility while using radiographic images as disclosed by Mata in ¶0023.
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 11, Holthuizen in view of Mata teaches the method of claim 10, further comprising manually manipulating a surgical instrument toward the anatomical structure (Mata ¶0020 discloses the medical professional using the method to guide the drill during the IM nailing procedure, therefore the medical professional is manually controlling the drill), such that at least a distal tip of the surgical instrument is depicted in at least one of the fluoroscopic and video stream of images (¶0042, Mata "The fluoroscopic image 400b can depict, for example, the position of the cutting tip"). See Claim 7 for rationale, its parent claim.
Claims 14, 19-20 and 22 are rejected under 35 U.S.C. 103 as unpatentable over Finley et al (US Patent Publication US 2023/0036038 A1, hereafter referred to as Finley) in view of Gorek et al (WO Patent Publication WO 2007136784 A2, hereafter referred to as Gorek).
Regarding Claim 14, Finley teaches a surgical system (Finley ¶0007 discloses a system for generating images during a surgical procedure), comprising:
a robotic arm carrying a fluoroscopic imaging device having an x-ray emitter (Finley Fig 1 ¶0023, discloses an mobile C arm with an x-ray device), wherein the fluoroscopic imaging device is configured to generate a first stream of fluoroscopic images of an anatomical structure along a first beam axis at a first orientation relative to the anatomical structure (Finley ¶0025 discloses an initial three-dimensional scan is used to provide a first three-dimensional image data set and second three dimensional scan is used to provide a second three-dimensional image data set), and the fluoroscopic imaging device is also configured to generate a second stream of fluoroscopic images of the anatomical structure along a second beam axis at a second orientation relative to the anatomical structure (Finley ¶0026 discloses the viewing angle of the scan may change due to the position of an implant, therefore making the viewing angle of the second scan different),
and the robotic arm is manipulatable for adjusting a relative position between the fluoroscopic imaging device and the anatomical structure (Finley ¶0026 discloses the C arm being movable so the view of the scan can be adjusted);
a processor in communication with the fluoroscopic imaging device and the robotic arm (Finley ¶0023 discloses the arm and the imaging device being in communication with the processor), the processor further in communication with a memory having instructions stored therein, wherein the processor is configured to execute the instructions (Finley ¶0027 discloses the processor including a memory and executing instructions) upon the first and second streams of fluoroscopic images (Finley ¶0025 discloses an initial three-dimensional scan is used to provide a first three-dimensional image data set and second three dimensional scan is used to provide a second three-dimensional image data set) and responsively:
plot, in the second stream of fluoroscopic images (Finley ¶0025 discloses an initial three-dimensional scan is used to provide a first three-dimensional image data set and second three dimensional scan is used to provide a second three-dimensional image data set),
a display in communication with the processor, wherein the display is configured to depict an augmented version of the second stream of fluoroscopic images (Finley ¶0022 discloses a processor configured to provide instructions to a display where the display shows the implant overlayed over the image data) overlaying the anatomical structure (Finley ¶0022 discloses a processor configured to provide instructions to a display where the display shows the implant overlayed over the image data).
Finley does not explicitly disclose wherein the second beam axis intersects the first beam axis and is substantially perpendicular to the first beam axis,
identify at least one anchor hole in an implant that resides within the anatomical structure,
reposition the fluoroscopic imaging device so that the first beam axis extends orthogonal to the at least one anchor hole); and
a reference axis that extends centrally through the at least one anchor hole,
that shows the reference axis.
Gorek is in the same field of image analysis assisted procedure. Further, Gorek teaches wherein the second beam axis intersects the first beam axis and is substantially perpendicular to the first beam axis (Gorek Pg 39 Lines 12-25 discloses moving the c arm so that the first and second directions of the imaging view being perpendicular to each other),
identify at least one anchor hole in an implant that resides within the anatomical structure (Gorek Pg 45 Lines 15-20 disclose finding the axis for the pilot hole for a pedicle screw implantation);
reposition the fluoroscopic imaging device so that the first beam axis extends orthogonal (Gorek Pg 23 Line 25-30 and Pg 24 Lines 11-16 disclose the instrument being rotated to be perpendicular with the spine where the pilot holes are located) to the at least one anchor hole (Gorek Pg 45 Lines 15-20 disclose finding the axis for the pilot hole for a pedicle screw implantation); and
a reference axis that extends centrally through the at least one anchor hole (Gorek Pg 35 Lines 6-22 disclose drawing a vertical reference line through the target of the pilot hole);
that shows the reference axis (Gorek Pg 35 Lines 6-22 disclose drawing a vertical reference line through the target of the pilot hole).
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 the invention of Finley by incorporating the axis geometry in relation to the placement and surgical plan concerning the implant that is taught by Gorek, to make an invention that can more accurately pinpoint the location of the implant thus, one of ordinary skill in the art would be motivated to combine the references since an object of the present invention is to address the need for reducing the challenge
associated with determining the optimal or desired trajectory for surgical instruments and/or
implants and monitoring the trajectory of surgical instruments and/or implants during surgery.as disclosed by Gorek in Pg 4 Lines 15-20.
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 19, Finley teaches a method (Finley ¶0005 discloses a method), comprising:
generating a first fluoroscopic stream of images along a first beam axis (Finley ¶0025 discloses an initial three-dimensional scan is used to provide a first three-dimensional image data set and second three dimensional scan is used to provide a second three-dimensional image data set), the first fluoroscopic stream of images showing an implant residing in an anatomical structure (Finley ¶0005 discloses determined position of the at least one surgical implant, overlaying a virtual representation of the at least one surgical implant on the registered and segmented at least one vertebral body from the at least one image of the first three-dimensional image data set);
generating a second fluoroscopic stream of images of the anatomical structure along a second beam axis (Finley ¶0025 discloses an initial three-dimensional scan is used to provide a first three-dimensional image data set and second three dimensional scan is used to provide a second three-dimensional image data set),
processing the first and second fluoroscopic streams of images with a processor (Finley ¶0023 discloses the image data being transmitted to a processing device) in communication with memory (Finley ¶0027 discloses a processor in conjunction with a memory), the processing step comprising:
calculating a pixel ratio of the reference feature in pixels per unit length (Finley ¶0094-¶0095 discloses comparing pixels to find the best size for the implant, which could include length);
depicting the second image stream on a display (Finley ¶0022 discloses a processor configured to provide instructions to a display where the display shows the implant overlayed over the image data),
is depicted in the second image stream overlaying the anatomical structure (Finley ¶0022 discloses a processor configured to provide instructions to a display where the display shows the implant overlayed over the image data).
Finley does not explicitly disclose that intersects the first beam axis at an angle,
identifying a reference feature of the implant;
adjusting an orientation of the first beam axis, thereby causing the first beam axis to extend orthogonal to the reference feature;
generating a reference axis extending centrally through the reference feature such that the reference axis is parallel with the first beam axis; and
wherein reference axis.
Gorek is in the same field of image analysis assisted procedure. Further, Gorek teaches that intersects the first beam axis at an angle (Gorek Pg 39 Lines 12-25 discloses moving the c arm so that the first and second directions of the imaging view being perpendicular to each other),
identifying a reference feature of the implant (Gorek Pg 45 Lines 15-20 disclose finding the axis for the pilot hole for a pedicle screw implantation which can be interpreted as a feature of the implant);
adjusting an orientation of the first beam axis (Gorek Pg 23 Line 25-30 and Pg 24 Lines 11-16 disclose the instrument being rotated to be perpendicular with the spine where the pilot holes are located) , thereby causing the first beam axis to extend orthogonal to the reference feature (Gorek Pg 45 Lines 15-20 disclose finding the axis for the pilot hole for a pedicle screw implantation);
generating a reference axis extending centrally through the reference feature (Gorek Pg 35 Lines 6-22 disclose drawing a vertical reference line through the target of the pilot hole) such that the reference axis is parallel with the first beam axis (Gorek Pg 35 Lines 1-5 disclose that the C-arm may then be oriented so that the fluoroscope's x-ray beam is parallel to the axis of the pedicle in one or both axes); and
wherein reference axis (Gorek Pg 35 Lines 6-22 disclose drawing a vertical reference line through the target of the pilot hole).
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 the invention of Finley by incorporating the axis geometry in relation to the placement and surgical plan concerning the implant that is taught by Gorek, to make an invention that can more accurately pinpoint the location of the implant thus, one of ordinary skill in the art would be motivated to combine the references since an object of the present invention is to address the need for reducing the challenge
associated with determining the optimal or desired trajectory for surgical instruments and/or
implants and monitoring the trajectory of surgical instruments and/or implants during surgery.as disclosed by Gorek in Pg 4 Lines 15-20.
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 20, Finley in view of Gorek teaches the method of claim 19, further comprising calculating a distance (Gorek Pg 46 Lines 15-25 disclose the space between the reference points) along the reference axis between two reference points of the anatomical structure (Gorek Pg 46 Lines 1-10 disclose the reference axis being drawn between two reference points). See Claim 19 for rationale, its parent claim.
Regarding Claim 22, Finley in view of Gorek teaches the method of claim 19, wherein the second beam axis is substantially perpendicular to the first beam axis (Gorek Pg 39 Lines 12-25 discloses moving the c arm so that the first and second directions of the imaging view being perpendicular to each other). See Claim 19 for rationale, its parent claim.
Claims 15-18 are rejected under 35 U.S.C. 103 as unpatentable over Finley et al in view of Gorek in further view of Navab et al (N. Navab, S. -M. Heining and J. Traub, "Camera Augmented Mobile C-Arm (CAMC): Calibration, Accuracy Study, and Clinical Applications," in IEEE Transactions on Medical Imaging, vol. 29, no. 7, pp. 1412-1423, July 2010, hereafter referred to as Navab).
Regarding Claim 15, Finley in view of Gorek teaches the surgical system of claim 14, further comprising a user interface having inputs in communication with the processor (Finley ¶0021 discloses user input via a touch screen display in conjunction with a processor).
Finley in view of Gorek does not explicitly disclose wherein the inputs are configured to allow a user to select locations along the reference axis and the processor is configured to responsively calculate a distance along the reference axis between the selected locations.
Navab is in the same field of image analysis assisted procedure. Further, Navab teaches wherein the inputs are configured to allow a user to select locations along the reference axis (Navab, Section II, B, "Within our application, we select four corresponding points in the video image and in the X-ray image"), and the processor is configured to responsively calculate a distance along the reference axis between the selected locations (Navab, Section IV, "The centroids of the markers are extracted in both images with subpixel accuracy and used to compute the distance between corresponding point pairs.").
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 the invention of Finley in view of Gorek by incorporating annotated images and distance calculation that is taught by Navab, to make an invention that can more accurately pinpoint the location of the implant and display it to the user; thus, one of ordinary skill in the art would be motivated to combine the references since an object of the present invention is to reduce the amount of x rays and therefore radiation the patient and clinician are exposed to during surgical procedures. (Section IV, Navab,)
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 16, Finley in view of Gorek in view of Navab teaches the surgical system of claim 15, wherein the processor is further configured to execute additional instructions upon at least one of the first and second streams of fluoroscopic images data (Finley ¶0023 discloses the image data being transmitted to a processing device and ¶0027 discloses the processor including a memory and executing instructions) and responsively display visual indicia within the augmented version of the second stream along an anatomical landmark of the anatomical structure (Figure 7, Navab, "Visualization of the image overlay system for dorsal spinal interventions. Four pedicle screws were placed with the system. The red crosshair defines one entry point for the awl or drill."). See Claim 15 for rationale, its parent claim.
Regarding Claim 17, Finley in view of Gorek in view of Navab teaches the surgical system of claim 16, wherein the processor is further configured to execute further additional instructions upon at least one of the first and second streams of fluoroscopic images data and (Finley ¶0023 discloses the image data being transmitted to a processing device and ¶0027 discloses the processor including a memory and executing instructions) responsively generate an augmented version of the first stream of fluoroscopic images that shows additional visual indicia along the anatomical landmark (Figure 7, Navab, "Visualization of the image overlay system for dorsal spinal interventions. Four pedicle screws were placed with the system. The red crosshair defines one entry point for the awl or drill.") See Claim 15 for rationale, its parent claim.
Regarding Claim 18, Finley in view of Gorek in view of Navab teaches the surgical system of claim 17, wherein the inputs are configured to allow a user to toggle (Finley ¶0027 discloses the user being able to select and manipulate the on screen images) between the augmented version of the first stream (Finley ¶0025 discloses an initial three-dimensional scan is used to provide a first three-dimensional image data set and second three dimensional scan is used to provide a second three-dimensional image data set) and the augmented version of the second stream (Figure 7, Navab, "Visualization of the image overlay system for dorsal spinal interventions. Four pedicle screws were placed with the system. The red crosshair defines one entry point for the awl or drill."). See Claim 15 for rationale, its parent claim.
Allowable Subject Matter
Claims 12 and 13 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 an examiner’s statement of reasons for allowance:
Although Holt and Mata disclose a distal tip being depicted in the fluoroscopic images and the combination of the fluoroscopic and video images to create an augmented image in real time, none of the prior art specifically teaches that the distal tip is depicted in both the fluoroscopic stream and the video stream. Claim 13 is dependent on Claim 12 which is why it is objected to, even though is it taught by Mata.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Reference Cited
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US Patent Publication 20200138518-A1 to Lang et al. discloses an optical guidance system for procedures.
US Patent Publication 20200188058-A1 to Mata et al. discloses a surgical instrument mounted display system.
US Patent Publication 20210169605-A1 to Calloway et al. discloses an augmented reality headset for navigated robotic surgery.
Conclusion
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/RACHEL L ROBERTS/Examiner, Art Unit 2674
/ONEAL R MISTRY/Supervisory Patent Examiner, Art Unit 2674
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