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 1-20 and 21 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 07/28/2026. 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 12-13 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 objects to claims 1, 4, 6-7, 14, and 22 under 35 U.S.C. § 112 in view of the recitation of "substantially." The term "substantially" is no longer recited in the claims, and thus the objections should be withdrawn.” therefore, the 35 U.S.C. § 112 rejection should be removed (See remarks, Pg 8, Paragraph 2).
In regards to the argument on Argument 2, Applicant/s state/s “Holthuizen expressly discloses that the alleged at least one reference feature does not need to be represented in the fluoroscopic image data and the video image data-let alone reference positions of such alleged at least one reference feature being co-registered in the manner recited in independent claim 1.” therefore, the rejection of claim 1 should be removed (See remarks, Pg 9-10, Paragraph 3 and Paragraph 1).
In regards to the argument on Argument 3, Applicant/s state/s “Holthuizen does not disclose 1) the alleged marker necessarily being shown in the alleged fluoroscopic image data, 2) the alleged marker being shown in the alleged video image data, and 3) the alleged marker occupying the same area in in alleged superimposed adjusted versions of the alleged video and fluoroscopy streams. Rather, as discussed above, even if Holthuizen’ s system would include the alleged marker in both alleged video and fluoroscopy stream, such would be the result of happenstance. This is because Holthuizen' s system relies upon the light detectors 12 detecting light from light sources 10 to determine relative 3D positions-not coregistering based on detection of the light detectors 12 in both alleged video and fluoroscopy streams.” therefore, the rejection of claim 3 should be removed (See remarks, Pg 10, Paragraph 4).
In regards to the argument on Argument 4, Applicant/s state/s “Claim 9 as amended recites that "generating a fluoroscopic stream of images of an anatomical structure and at least one reference feature; generating a video stream of images, with an optical video imaging device, of an exterior of the anatomical structure and the at least one reference feature; co-registering the fluoroscopic stream of images with the video stream of images based on a reference position, of the at least one reference feature relative to the anatomical structure, in the fluoroscopic stream of images and the video stream of images.".” therefore, the rejection of claim 9 should be removed (See remarks, Pg 10, Paragraph 7).
In regards to the argument on Argument 5, Applicant/s state/s “Gorek does not cure the deficiencies of Finley in a manner that would lead a person of ordinary skill in the art to actually modify Finley's device to plot, in the alleged second stream of fluoroscopic images, a reference axis that extends centrally through the at least one anchor hole of the alleged implant, in the manner recited in independent claim 14-let alone to arrive at each and every feature of independent claim 14 as amended.” therefore, the rejection of claim 14 should be removed (See remarks, Pg 12, paragraph 3).
In regards to the argument on Argument 6, Applicant/s state/s “Independent claim 19 as amended recites "generating a first fluoroscopic stream of images along a first beam axis, the first fluoroscopic stream of images showing an implant residing in an anatomical structure; generating a second fluoroscopic stream of images of the anatomical structure, and the implant residing in the anatomical structure, along a second beam axis that intersects the first beam axis at an angle;" and "generating a reference axis extending centrally through the reference feature such that the reference axis is parallel with the first beam axis; and depicting the second image stream on a display, wherein reference axis is depicted in the second image stream overlaying the anatomical structure.".” therefore, the rejection of claim 19 should be removed (See remarks, Pg 13, paragraph 04).
In regards to the argument on Argument 7, Applicant/s state/s “Claim 20 recites "calculating a distance along the reference axis between two reference points of the anatomical structure." The Office action cites Gorek as allegedly disclosing calculating a distance. However, the Office Action identifies disclosure of a disc space, without identifying any disclosure of calculating a distance of the space, let alone calculating a distance along a reference axis in the manner recited in claim 20.” therefore, the rejection of claim 20 should be removed (See remarks, Pg 13, Paragraph 6).
Examiner’s Responses:
In response to Argument 1, Applicant’s arguments, see Remarks, filed 07/28/2026, have been considered and are persuasive, therefore the 35 U.S.C. § 112 rejections have been withdrawn.
In response to Argument 2, Applicant’s arguments, see Remarks, filed 07/28/2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 102 have been fully considered but are not persuasive. Therefore the rejection of Claim 1 is maintained 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).
The Examiner finds that Holthuizen teaches on the claim language. Holthuizen teaches in ¶0037 that the images of the x ray and the video camera are combined due to the spatial relationship based on the marker, which is used in conjunction with the light tracking system. Applicant argues “Holthuizen expressly discloses that the alleged at least one reference feature does not need to be represented in the fluoroscopic image data and the video image data-let alone reference positions of such alleged at least one reference feature being co-registered in the manner recited in independent claim 1”; The Examiner finds that in ¶0037 and Fig 3 Holt discloses that the detector that is used to track the patients position is a detector that is made of radiopaque material and is visible in the x ray image and may also be identified in the video camera image. The detector being the reference with which the position is calculated that is used to align the two images, therefore resulting in a synchronized view of the Xray and the video as detailed in ¶0037. The Examiner finds that during prosecution, claims must be given their broadest reasonable interpretation while reading claim language in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In construing the meaning of claims terms, caution must be taken not to import limitations from the specification as “[i]t is the claims that measure the invention.” See SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (en banc) The Examiner interprets that under broadest reasonable interpretation “reference feature” have no special definition in the claims, and therefore “reference feature” can be interpreted as the area of the body that the detector in Fig 3, 12 is placed on, as the detector is what is used to align the Xray and video images to produce the synchronized images as taught by Holthuizen on Fig 3 and ¶0037. Therefore, the Examiner interprets that Holthuizen teaches the main concept of aligning and overlaying two different image sources to create a single combined image. The Examiner will maintain prior art Holthuizen and details of the rejection are below.
In response to Argument 3, Applicant’s arguments, see Remarks, filed 07/28/2026, with respect to the rejection(s) of claim 3 under 35 U.S.C. 102 have been fully considered but are not persuasive. Therefore the rejection of Claim 3 is maintained 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).
The Examiner finds that Holthuizen teaches on the claim language. Holthuizen teaches in ¶0037 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. Applicant argues “Holthuizen does not disclose 1) the alleged marker necessarily being shown in the alleged fluoroscopic image data, 2) the alleged marker being shown in the alleged video image data, and 3) the alleged marker occupying the same area in in alleged superimposed adjusted versions of the alleged video and fluoroscopy streams. Rather, as discussed above, even if Holthuizen’ s system would include the alleged marker in both alleged video and fluoroscopy stream, such would be the result of happenstance. This is because Holthuizen' s system relies upon the light detectors 12 detecting light from light sources 10 to determine relative 3D positions-not coregistering based on detection of the light detectors 12 in both alleged video and fluoroscopy streams.” The Examiner finds that in ¶0037 and Fig 3 Holt discloses that the detector that is used to track the patients position is a detector that is made of radiopaque material and is visible in the x ray image and may also be identified in the video camera image in ¶0037, which directly negates the first point and second point made by the applicant as the detector is being shown in the x ray data specifically shown in Fig 3, 12 Holthuizen. The detector being the reference with which the position is calculated that is used to align the two images, therefore resulting in a synchronized view of the Xray and the video as detailed in ¶0037. The Examiner finds that during prosecution, claims must be given their broadest reasonable interpretation while reading claim language in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In construing the meaning of claims terms, caution must be taken not to import limitations from the specification as “[i]t is the claims that measure the invention.” See SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (en banc) The Examiner interprets that under broadest reasonable interpretation “marker” have no special definition in the claims, and therefore “detector” can be interpreted as the detector is what is used to align the Xray and video images to produce the synchronized images as taught by Holthuizen on Fig 3 and ¶0037, since the detector is used as a way to determine the aligned position and is made of radiopaque material as detailed in ¶0037 is effectively functions as a marker for position of synchronization. In addition one of ordinary skill in the art would find that the “synchronized viewing angle and with the video image in the same scale as the x-ray image” as taught by Holthuizen in ¶0037 would mean that the same area defined by the marker and spatial relationship would be presented to the user as shown in Fig 1, rendering the applicants argument moot. Therefore, the Examiner interprets that Holthuizen teaches the concept of aligning and overlaying two different image sources to create a single combined image. The Examiner will maintain prior art Holthuizen and details of the rejection are below.
In response to Argument 4, Applicant’s arguments, see Remarks, filed 07/28/2026, with respect to the rejection(s) of claim 9 under 35 U.S.C. 102 have been fully considered but are not persuasive. Therefore the rejection of Claim 9 is maintained 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).
The Examiner finds that Holthuizen teaches on the claim language. Holthuizen teaches in ¶0037 that the images of the x ray and the video camera are combined due to the spatial relationship based on the marker, which is used in conjunction with the light tracking system. Applicant argues “Holthuizen expressly discloses that the alleged at least one reference feature does not need to be represented in the fluoroscopic image data and the video image data-let alone reference positions of such alleged at least one reference feature being co-registered in the manner recited in independent claim 1”; The Examiner finds that in ¶0037 and Fig 3 Holt discloses that the detector that is used to track the patients position is a detector that is made of radiopaque material and is visible in the x ray image and may also be identified in the video camera image. The detector being the reference with which the position is calculated that is used to align the two images, therefore resulting in a synchronized view of the Xray and the video as detailed in ¶0037. The Examiner finds that during prosecution, claims must be given their broadest reasonable interpretation while reading claim language in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In construing the meaning of claims terms, caution must be taken not to import limitations from the specification as “[i]t is the claims that measure the invention.” See SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (en banc) The Examiner interprets that under broadest reasonable interpretation “reference feature” have no special definition in the claims, and therefore “reference feature” can be interpreted as the area of the body that the detector in Fig 3, 12 is placed on, as the detector is what is used to align the Xray and video images to produce the synchronized images as taught by Holthuizen on Fig 3 and ¶0037. Therefore, the Examiner interprets that Holthuizen teaches the main concept of aligning and overlaying two different image sources to create a single combined image. The Examiner will maintain prior art Holthuizen and details of the rejection are below.
In response to Arguments 5 and 6, Applicant’s arguments, see Remarks, filed 07/28/2026, with respect to the rejection(s) of claims 14 and 19 under 35 U.S.C. 103 have been fully considered but are not persuasive. Therefore the rejection of Claim 14 and 19 is maintained 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).
The Examiner finds that Finley teaches on the claim language. Finley teaches that the scan images include the anatomy and at least one surgical implant in ¶0005-¶0006, ¶0022, ¶0083, ¶0096, and Fig 8, 804 as presented in the amended claim language. Applicant argues “Gorek does not cure the deficiencies of Finley in a manner that would lead a person of ordinary skill in the art to actually modify Finley's device to plot, in the alleged second stream of fluoroscopic images, a reference axis that extends centrally through the at least one anchor hole of the alleged implant, in the manner recited in independent claim 14-let alone to arrive at each and every feature of independent claim 14 as amended.” The Examiner respectfully disagrees. The Examiner finds that Gorek discloses the use of plotting the axis for screw implantation on Pg 45 Lines 15-20 by using a vertical reference line drawn through the target of the piolet hole as disclosed on Pg 45 Lines 15-20, Gorek also discloses adjusting the instruments to align specifically with the axis of the reference feature in Pg 23 Line 25-30 and Pg 24 Lines 11-16. Additionally the Examiner provided appropriate rationale and reasoning in the office action as a person with ordinary skill in the art would be motivated 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 in Pg 45 Lines 15-20, to make an invention that can more accurately pinpoint the location determination 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. Therefore, the Examiner made a proper determination of obviousness under 35 U.S.C. §103, and also provided an appropriate supporting rationale in view of the decision by the Supreme Court in KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007). The Examiner’s rational are based on the Office’s current understanding of the law, and are believed to be fully consistent with the binding precedent of the Supreme Court. Furthermore, the Examiner supported the rejection under 35 U.S.C. §103 via making the clear articulation of the reason(s) why the claimed invention would have been obvious by citing the specific areas in the prior art references. Further the Examiner, clearly stating the modification of the inventions, supported the rejection under 35 U.S.C. §103 by making the analysis explicit. Last, the Examiner did not make conclusory statements. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that “‘[R]ejections on obviousness cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’” KSR, 550 U.S. at 82 USPQ2d at 1396. Therefore, the Examiner has established a proper 35 U.S.C. §103 rejection with Finley in view of Gorek, which is disclosed in detail below.
In response to Arguments 7, Applicant’s arguments, see Remarks, filed 07/28/2026, with respect to the rejection(s) of claim 20 under 35 U.S.C. 103 have been fully considered but are not persuasive. Therefore the rejection of Claim 20 is maintained 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).
The Examiner finds that Gorek teaches on the claim language. Gorek teaches the determination of the space between two reference points in Fig 51 and Pg 46 46 Lines 1-25. Applicant argues “Claim 20 recites "calculating a distance along the reference axis between two reference points of the anatomical structure." The Office action cites Gorek as allegedly disclosing calculating a distance. However, the Office Action identifies disclosure of a disc space, without identifying any disclosure of calculating a distance of the space, let alone calculating a distance along a reference axis in the manner recited in claim 20.” The Examiner respectfully disagrees, Gorek discloses on Pg 46 Lines 1-10 and with looking at Fig 49 and 50 it can clearly be seen that the distance between the points is represented by the line and a person of ordinary skill in the art would understand that in determining the angles of the lines drawn would be part of the process for calculating the space shown in Fig 19 and Fig 20. The Examiner finds that during prosecution, claims must be given their broadest reasonable interpretation while reading claim language in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In construing the meaning of claims terms, caution must be taken not to import limitations from the specification as “[i]t is the claims that measure the invention.” See SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (en banc) The Examiner interprets that under broadest reasonable interpretation “distance” and “calculate” have no special definition in the claims, and therefore “space between two points” can be interpreted as a distance as taught by Gorek on Pg 46 Lines 15-25 and “calculate” can be defined as determine as disclosed by the process for determining the space as taught by Gorek on Pg 46 Lines 1-10 and with looking at Fig 49 and 50 it can clearly been see that the distance between the points is represented by the line and a person of ordinary skill in the art would understand that in determining the angles of the lines drawn would be part of the process for calculating the distance a shown in Fig 19 and 20. Therefore, the Examiner will maintain prior art Gorek, and details of the rejection are below.
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 § 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 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 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 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) and at least one reference feature (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) ;
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) based on a reference position, of the at least one reference feature relative 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 the fluoroscopic stream of images and the video stream of images (Holstien ¶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 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 co-registering the fluoroscopic stream of images with the video stream of images includes registering the reference positions of that at least one reference feature in the fluoroscopic stream of images and the 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), wherein the augmented image stream is depicted such that the reference positions are coregistered (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 the augmented image stream includes a representation 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), and 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 and an implant that resides within the anatomical structure (Finley ¶0005-¶0006, ¶0022, ¶0083, ¶0096, and Fig 8, 804 discloses the scan including the anatomy and at least one surgical implant), 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, and the implant (Finley ¶0005-¶0006, ¶0022, ¶0083, ¶0096, and Fig 8, 804 discloses the scan including the anatomy and at least one surgical implant), 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:
of the implant in the first stream of fluoroscopic images(Finley ¶0005-¶0006, ¶0022, ¶0083, ¶0096, and Fig 8, 804 discloses the scan including the anatomy and at least one surgical implant);
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 perpendicular to the first beam axis,
identify at least one anchor hole in the 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 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 the 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 and the implant residing in the anatomical structure (Finley ¶0005-¶0006, ¶0022, ¶0083, ¶0096, and Fig 8, 804 discloses the scan including the anatomy and at least one surgical implant), 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 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
55. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
56. 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.
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/RACHEL L ROBERTS/Examiner, Art Unit 2674 /ONEAL R MISTRY/Supervisory Patent Examiner, Art Unit 2674
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