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
Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2024 has been considered by the examiner.
Claim Objections
Claims 16-18 are objected to because of the following informalities:
In claim 16, lines 11-17 should be corrected as follows:
“determining an imaging direction onto the region of interest based on the X-ray image[[,]] ;
determining a 3D position of the anchor point in the 3D coordinate system at the first point in time based on: the 2D position of the anchor point in the X-ray image, and
the imaging direction onto the region of interest for determining a 3D position
and 3D orientation of the surgical object relative to the region of interest at the first point in time based on:
the 3D model of the surgical object, and
the 3D position of the anchor point in the 3D coordinate system at the first point in time.”
In claim 17, lines 11-17 should be corrected as follows:
“determine an imaging direction onto the region of interest based on the X-ray image[[,]] ;
determine a 3D position of the anchor point in the 3D coordinate system at the first point in time based on: the 2D position of the anchor point in the X-ray image, and
the imaging direction onto the region of interest for determining a 3D position
and 3D orientation of the surgical object relative to the region of interest at the first point in time based on:
the 3D model of the surgical object, and
the 3D position of the anchor point in the 3D coordinate system at the first point in time.”
In claim 18, lines 13-19 should be corrected as follows:
“determine an imaging direction onto the region of interest based on the X-ray image[[,]] ;
determine a 3D position of the anchor point in the 3D coordinate system at the first point in time based on: the 2D position of the anchor point in the X-ray image, and
the imaging direction onto the region of interest for determining a 3D position
and 3D orientation of the surgical object relative to the region of interest at the first point in time based on:
the 3D model of the surgical object, and
the 3D position of the anchor point in the 3D coordinate system at the first point in time.”
The office respectfully requests that the Applicant rewrite the claims as suggested above so that the metes and bounds of the claims can be better understood in order to avoid a 112(b)-indefiniteness rejection.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 17 recites limitations that use words like “means” (or “step”) or similar terms with functional language and does invoke 35 U.S.C. 112(f):
Claim 17; recites the limitation, “a processing unit configured to…,” [Line 2].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
After a careful analysis, as disclosed above, and a careful review of the specification the following limitations in claim 9:
“processing unit” (Page 10, Paragraph [0003] – “It is noted that a processing unit may be realized by only one processor performing all the steps of the process, or by a group or a plurality of processors, which need not be located at the same place.” Thus, a processing unit does have sufficient structure associated with it wherein it is a processor.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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 of this title, if the
differences between the claimed invention and the prior art are such that the claimed
invention as a whole would have been obvious before the effective filing date of the
claimed invention to a person having ordinary skill in the art to which the claimed
invention pertains. Patentability shall not be negated by the manner in which the
invention was made.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over HOLTHUIZEN (US 20240065773 A1), hereinafter referenced as HOLTHUIZEN in view of KAY (US 20240366238 A1), hereinafter referenced as KAY.
Regarding claim 16, HOLTHUIZEN teaches a method of 3D navigation for musculoskeletal surgery (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses FIG. 3 shows steps of an example of a method 200 for navigation support. Fig. 2, Paragraph [0071] – HOLTHUIZEN discloses the system 10 for navigation support is provided as a navigation-imaging system (or imaging-navigation system), or as a part of such system, configured for providing navigation and imaging during medical interventions or medical examinations.)
based on a single 2D X-ray image (Fig. 3, Paragraph [0084] – HOLTHUIZEN discloses detection of 3D objects is provided by performing a reconstruction with a limited set of 2D X-ray images. For specific marker arrangements, the 3D positions can be calculated using a single 2D X-ray image, although the usage of multiple images is preferred to minimize the depth error of said calculation. See also Paragraph [0064].)) comprising:
receiving an X-ray image generated at a first point in time (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses a plurality of 2D X-ray images of a subject's body are acquired from different angles. See also Paragraph [0084].),
wherein the X-ray image is a 2D projection image depicting at least part of a surgical object including an anchor point (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses a plurality of 2D X-ray images of a subject's body are acquired from different angles. A set of markers [wherein marker is an anchor point], which are visible in X-ray images and which are detectable by a navigation system, is assigned to the subject. Paragraph [0046-48] – HOLTHUIZEN discloses in a first option, the markers are provided as separate markers that are attached to the subjects, e.g. on the skin of a subject. In a second option, the markers are provided as anatomical markers, i.e. physical properties of a subject that are visible in both X-ray and optical tracking. In a further option, the markers are provided as implants of a subject that are visible in both X-ray and electromagnetic tracking.)
and a region of interest within a patient's anatomy (Fig. 5, Paragraph [0125] – HOLTHUIZEN discloses in FIG. 5, an example is shown, according to which a set of markers 136 is provided, which markers 136 are configured for temporal assignment to the subject 128. As indicated, the set of markers is temporarily assigned to a subject, for example prepared around or outside an area of a planned intervention.);
receiving a 3D model of the surgical object (Fig. 3, Paragraph [0153] – HOLTHUIZEN discloses when geometric information is used, such as known size and shape of the markers, the image data can be adapted, i.e. corrected accordingly. As an example, in 2D images, the center point is detected in 3D and models of the markers are used for more detailed location detection. Paragraph [0046-48] – HOLTHUIZEN discloses in a first option, the markers are provided as separate markers that are attached to the subjects, e.g. on the skin of a subject. In a second option, the markers are provided as anatomical markers, i.e. physical properties of a subject that are visible in both X-ray and optical tracking. In a further option, the markers are provided as implants of a subject that are visible in both X-ray and electromagnetic tracking.),
wherein the position of the anchor point is known in the 3D model (Fig. 8, Paragraph [0139] – HOLTHUIZEN discloses FIG. 8 shows an illustration 148 of an example of a registered reconstructed 3D volume for navigation. FIG. 8 shows a side view of the spine structure 144. The spine structure 144 is visible and the markers 136 are also depicted.);
determining a 2D position of the anchor point in the X-ray image (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses in an identification step 206, the markers in the 2D X-ray images are identified based on image data of the plurality of 2D X-ray images. Paragraph [0130] – HOLTHUIZEN further discloses markers 136 are provided to be detectable in a 2D X-ray image with their respective six degrees of freedom of movement, i.e. their possible location and orientation in space. See also Fig. 3a, Paragraph [0119].);
determining a 3D position of the anchor point in the 3D coordinate system at the first point in time based on (i) the 2D position of the anchor point in the X-ray image (Fig. 1, Paragraph [0045] – HOLTHUIZEN discloses data processor 14 is further configured to register the reconstructed 3D volume of the subject to a current spatial position of the subject based on the detected current spatial location of the markers and the determined spatial location of the markers in relation to the 3D volume of the subject.),
Although HOLTHUIZEN further teaches and (iv) the 3D position of the anchor point in the 3D coordinate system at the first point in time (Fig. 8, Paragraph [0136] – HOLTHUIZEN discloses X-ray visible markers 136 are detected, e.g. automatically, in a subset of the 2D X-ray images, e.g. the first position and the second position) and the detected markers 136 are used to calculate the 3D position of the markers within the extended 3D cone beam CT volume.).
HOLTHUIZEN fails to explicitly teach receiving a 3D data set describing the region of interest and defining a 3D coordinate system; and determining an imaging direction onto the region of interest based on the X-ray image, and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time based on (iii) the 3D model of the surgical object,
However, KAY explicitly teaches receiving a 3D data set describing the region of interest and defining a 3D coordinate system (Fig. 18-20, Paragraph [0077] – KAY discloses FIGS. 18-20 illustrate how the spiral arrangement of the fiducials in the phantom show up in 2 differing 2D fluoroscopic images, and how these are marked to create the 3D coordinate reference frame that forms part of the 3D coordinate system through which the instrument travels and in which the tracking component of the present system tracks the movement of the instrument along a work-path from one point of interest to a second point of interest. See also Paragraphs [0102-0103].);
and determining an imaging direction onto the region of interest based on the X-ray image (Fig. 9, Paragraph [0073] – KAY discloses the fiducial base 400 is mounted on a pair of guide wires which are implanted into the patient anatomy. And completely within the field of view of the X-ray cone 505 produced by the C-arm X-ray source 501. By using the draw-wire 53 and gimbal base 41 to touch various points 502, 503, and 504, the relative positions and orientation [wherein orientation is direction] of the C-arm, the reference frame mechanical ground 1, global reference frame ground 500, and the patient 4, can all be registered and linked together in a single solid body coordinate system.),
and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time (Fig. 9, Paragraph [0073] – KAY discloses the fiducial base 400 is mounted on a pair of guide wires which are implanted into the patient anatomy. And completely within the field of view of the X-ray cone 505 produced by the C-arm X-ray source 501. By using the draw-wire 53 and gimbal base 41 to touch various points 502, 503, and 504, the relative positions and orientation of the C-arm, the reference frame mechanical ground 1, global reference frame ground 500, and the patient 4, can all be registered and linked together in a single solid body coordinate system.)
based on (iii) the 3D model of the surgical object (Fig. 14, Paragraph [0076] – KAY discloses FIGS. 14-20 illustrate an additional embodiment of the fiducial base or phantom 1399 in which the block 1400 is cylinder with holes 1405 that are arranged in a known geometric array, in this case, a spiral which makes a full rotation about the length of the cylindrical block 1400. KAY further discloses the spiral shape of the fiducials allows the system to create a coordinate reference system in 3D from 2D x-rays. See also Paragraph [0077].),
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of HOLTHUIZEN of having a method of 3D navigation for musculoskeletal surgery based on single 2D X- ray image comprising: receiving an X-ray image generated at a first point in time, wherein the X-ray image is a 2D projection image depicting at least part of a surgical object including an anchor point and a region of interest within a patient's anatomy; receiving a 3D model of the surgical object, wherein the position of the anchor point is known in the 3D model; determining a 2D position of the anchor point in the X-ray image; determining a 3D position of the anchor point in the 3D coordinate system at the first point in time based on: (i) the 2D position of the anchor point in the X-ray image, and (iv) the 3D position of the anchor point in the 3D coordinate system at the first point in time, with the teachings of KAY of having receiving a 3D data set describing the region of interest and defining a 3D coordinate system; and determining an imaging direction onto the region of interest based on the X-ray image, and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time based on (iii) the 3D model of the surgical object.
Wherein HOLTHUIZEN’s method wherein having receiving a 3D data set describing the region of interest and defining a 3D coordinate system; and determining an imaging direction onto the region of interest based on the X-ray image, and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time based on (iii) the 3D model of the surgical object.
The motivation behind this modification would have been to provide an enhanced method of 3D medical navigation based on 2D imaging that provides improved accuracy and real time positional information, since both HOLTHUIZEN and KAY relate to methods and systems for medical positional determination, wherein HOLTHUIZEN relates to guidance during a medical intervention, and relates in particular to a system for navigation support, to a navigated X-ray imaging arrangement for medical interventions of a subject; manually performing a registration is avoided, e.g. by using an optically tracked pointer and indicating several points on the patient, which manual registration can be prone to error and is time consuming, and KAY relates to fine precision control of an instrument so as to enable the user to manipulate the instrument in a reference system in 3D space aided by coordinated 2D images taken in differing planes; it can provide both position and angular information simultaneously, and advantageously, sufficiently in ‘real-time” to enable the use during surgery. Please see HOLTHUIZEN (US 20240065773 A1), Paragraph [0057-0059], and KAY (US 20240366238 A1), Paragraph [0002, 0029].
Regarding claim 17, HOLTHUIZEN teaches a device for 3D navigation during musculoskeletal surgery (Fig. 1, Paragraph [0045] - HOLTHUIZEN discloses FIG. 1 schematically shows an example of a system 10 for navigation support. Fig. 2, Paragraph [0071] – HOLTHUIZEN discloses the system 10 for navigation support is provided as a navigation-imaging system (or imaging-navigation system), or as a part of such system, configured for providing navigation and imaging during medical interventions or medical examinations.)
based on a single 2D X-ray image (Fig. 3, Paragraph [0084] – HOLTHUIZEN discloses detection of 3D objects is provided by performing a reconstruction with a limited set of 2D X-ray images. For specific marker arrangements, the 3D positions can be calculated using a single 2D X-ray image, although the usage of multiple images is preferred to minimize the depth error of said calculation. See also Paragraph [0064].)),
the device (Fig. 1, #10 called system, Paragraph [0045]) comprising a processing unit (Fig. 1, #14 called data processor, Paragraph [0045] – HOLTHUIZEN discloses system 10 comprises an image data input 12, a data processor 14, a marker detecting arrangement 16 and an output interface 18.) configured to:
receive an X-ray image generated at a first point in time (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses a plurality of 2D X-ray images of a subject's body are acquired from different angles. See also Paragraph [0084].),
wherein the X-ray image is a 2D projection image depicting at least part of a surgical object including an anchor point (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses a plurality of 2D X-ray images of a subject's body are acquired from different angles. A set of markers [wherein marker is an anchor point], which are visible in X-ray images and which are detectable by a navigation system, is assigned to the subject. Paragraph [0046-48] – HOLTHUIZEN discloses in a first option, the markers are provided as separate markers that are attached to the subjects, e.g. on the skin of a subject. In a second option, the markers are provided as anatomical markers, i.e. physical properties of a subject that are visible in both X-ray and optical tracking. In a further option, the markers are provided as implants of a subject that are visible in both X-ray and electromagnetic tracking.)
and a region of interest within a patient's anatomy (Fig. 5, Paragraph [0125] – HOLTHUIZEN discloses in FIG. 5, an example is shown, according to which a set of markers 136 is provided, which markers 136 are configured for temporal assignment to the subject 128. As indicated, the set of markers is temporarily assigned to a subject, for example prepared around or outside an area of a planned intervention.);
receive a 3D model of the surgical object (Fig. 3, Paragraph [0153] – HOLTHUIZEN discloses when geometric information is used, such as known size and shape of the markers, the image data can be adapted, i.e. corrected accordingly. As an example, in 2D images, the center point is detected in 3D and models of the markers are used for more detailed location detection. Paragraph [0046-48] – HOLTHUIZEN discloses in a first option, the markers are provided as separate markers that are attached to the subjects, e.g. on the skin of a subject. In a second option, the markers are provided as anatomical markers, i.e. physical properties of a subject that are visible in both X-ray and optical tracking. In a further option, the markers are provided as implants of a subject that are visible in both X-ray and electromagnetic tracking.),
wherein the position of the anchor point is known in the 3D model (Fig. 8, Paragraph [0139] – HOLTHUIZEN discloses FIG. 8 shows an illustration 148 of an example of a registered reconstructed 3D volume for navigation. FIG. 8 shows a side view of the spine structure 144. The spine structure 144 is visible and the markers 136 are also depicted.);
determine a 2D position of the anchor point in the X-ray image (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses in an identification step 206, the markers in the 2D X-ray images are identified based on image data of the plurality of 2D X-ray images. Paragraph [0130] – HOLTHUIZEN further discloses markers 136 are provided to be detectable in a 2D X-ray image with their respective six degrees of freedom of movement, i.e. their possible location and orientation in space. See also Fig. 3a, Paragraph [0119].);
determine a 3D position of the anchor point in the 3D coordinate system at the first point in time based on (i) the 2D position of the anchor point in the X-ray image (Fig. 1, Paragraph [0045] – HOLTHUIZEN discloses data processor 14 is further configured to register the reconstructed 3D volume of the subject to a current spatial position of the subject based on the detected current spatial location of the markers and the determined spatial location of the markers in relation to the 3D volume of the subject.),
Although HOLTHUIZEN further teaches and (iv) the 3D position of the anchor point in the 3D coordinate system at the first point in time (Fig. 8, Paragraph [0136] – HOLTHUIZEN discloses X-ray visible markers 136 are detected, e.g. automatically, in a subset of the 2D X-ray images, e.g. the first position and the second position) and the detected markers 136 are used to calculate the 3D position of the markers within the extended 3D cone beam CT volume.).
HOLTHUIZEN fails to explicitly teach receive a 3D data set describing the region of interest and defining a 3D coordinate system; and determine an imaging direction onto the region of interest based on the X-ray image, and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time based on (iii) the 3D model of the surgical object,
However, KAY explicitly teaches receive a 3D data set describing the region of interest and defining a 3D coordinate system (Fig. 18-20, Paragraph [0077] – KAY discloses FIGS. 18-20 illustrate how the spiral arrangement of the fiducials in the phantom show up in 2 differing 2D fluoroscopic images, and how these are marked to create the 3D coordinate reference frame that forms part of the 3D coordinate system through which the instrument travels and in which the tracking component of the present system tracks the movement of the instrument along a work-path from one point of interest to a second point of interest. See also Paragraphs [0102-0103].);
and determine an imaging direction onto the region of interest based on the X-ray image (Fig. 9, Paragraph [0073] – KAY discloses the fiducial base 400 is mounted on a pair of guide wires which are implanted into the patient anatomy. And completely within the field of view of the X-ray cone 505 produced by the C-arm X-ray source 501. By using the draw-wire 53 and gimbal base 41 to touch various points 502, 503, and 504, the relative positions and orientation [wherein orientation is direction] of the C-arm, the reference frame mechanical ground 1, global reference frame ground 500, and the patient 4, can all be registered and linked together in a single solid body coordinate system.),
and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time (Fig. 9, Paragraph [0073] – KAY discloses the fiducial base 400 is mounted on a pair of guide wires which are implanted into the patient anatomy. And completely within the field of view of the X-ray cone 505 produced by the C-arm X-ray source 501. By using the draw-wire 53 and gimbal base 41 to touch various points 502, 503, and 504, the relative positions and orientation of the C-arm, the reference frame mechanical ground 1, global reference frame ground 500, and the patient 4, can all be registered and linked together in a single solid body coordinate system.)
based on (iii) the 3D model of the surgical object (Fig. 14, Paragraph [0076] – KAY discloses FIGS. 14-20 illustrate an additional embodiment of the fiducial base or phantom 1399 in which the block 1400 is cylinder with holes 1405 that are arranged in a known geometric array, in this case, a spiral which makes a full rotation about the length of the cylindrical block 1400. KAY further discloses the spiral shape of the fiducials allows the system to create a coordinate reference system in 3D from 2D x-rays. See also Paragraph [0077].),
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of HOLTHUIZEN of having a device for 3D navigation during musculoskeletal surgery based on single 2D X-ray image, the device comprising a processing unit configured to: receive an X-ray image generated at a first point in time, wherein the X-ray image is a 2D projection image depicting at least part of a surgical object including an anchor point and a region of interest within a patient's anatomy; receive a 3D model of the surgical object, wherein the position of the anchor point is known in the 3D model; determine a 2D position of the anchor point in the X-ray image; determine a 3D position of the anchor point in the 3D coordinate system at the first point in time based on (i) the 2D position of the anchor point in the X-ray image, and (iv) the 3D position of the anchor point in the 3D coordinate system at the first point in time, with the teachings of KAY of having receive a 3D data set describing the region of interest and defining a 3D coordinate system; and determine an imaging direction onto the region of interest based on the X-ray image, and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time based on (iii) the 3D model of the surgical object.
Wherein HOLTHUIZEN’s device wherein having receive a 3D data set describing the region of interest and defining a 3D coordinate system; and determine an imaging direction onto the region of interest based on the X-ray image, and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time based on (iii) the 3D model of the surgical object.
The motivation behind this modification would have been to provide an enhanced method of 3D medical navigation based on 2D imaging that provides improved accuracy and real time positional information, since both HOLTHUIZEN and KAY relate to methods and systems for medical positional determination, wherein HOLTHUIZEN relates to guidance during a medical intervention, and relates in particular to a system for navigation support, to a navigated X-ray imaging arrangement for medical interventions of a subject; manually performing a registration is avoided, e.g. by using an optically tracked pointer and indicating several points on the patient, which manual registration can be prone to error and is time consuming, and KAY relates to fine precision control of an instrument so as to enable the user to manipulate the instrument in a reference system in 3D space aided by coordinated 2D images taken in differing planes; it can provide both position and angular information simultaneously, and advantageously, sufficiently in ‘real-time” to enable the use during surgery. Please see HOLTHUIZEN (US 20240065773 A1), Paragraph [0057-0059], and KAY (US 20240366238 A1), Paragraph [0002, 0029].
Regarding claim 18, HOLTHUIZEN teaches a non-transitory computer readable medium comprising processor-executable instructions (Fig. 1, Paragraph [0168] – HOLTHUIZEN discloses according to a further exemplary embodiment of the present invention, a computer readable medium, such as a CD-ROM, is presented wherein the computer readable medium has a computer program element stored on it which computer program element is described by the preceding section.)
for 3D navigation during musculoskeletal surgery (Fig. 2, Paragraph [0071] – HOLTHUIZEN discloses the system 10 for navigation support is provided as a navigation-imaging system (or imaging-navigation system), or as a part of such system, configured for providing navigation and imaging during medical interventions or medical examinations.)
based on single 2D X-ray image (Fig. 3, Paragraph [0084] – HOLTHUIZEN discloses detection of 3D objects is provided by performing a reconstruction with a limited set of 2D X-ray images. For specific marker arrangements, the 3D positions can be calculated using a single 2D X-ray image, although the usage of multiple images is preferred to minimize the depth error of said calculation. See also Paragraph [0064].),
the processor-executable instructions (Fig. 1, Paragraph [0158] – HOLTHUIZEN discloses a computer program is provided comprising computer readable code or instructions which when executed by a processor enable the processor to carry out the method of one of the examples above.)
when executed on the processor (Fig. 1, #14 called data processor, Paragraph [0045]) in a device (Fig. 1, #10 called system, Paragraph [0045]) configure the device to:
receive an X-ray image generated at a first point in time (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses a plurality of 2D X-ray images of a subject's body are acquired from different angles. See also Paragraph [0084].),
wherein the X-ray image is a 2D projection image depicting at least part of a surgical object including an anchor point (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses a plurality of 2D X-ray images of a subject's body are acquired from different angles. A set of markers [wherein marker is an anchor point], which are visible in X-ray images and which are detectable by a navigation system, is assigned to the subject. Paragraph [0046-48] – HOLTHUIZEN discloses in a first option, the markers are provided as separate markers that are attached to the subjects, e.g. on the skin of a subject. In a second option, the markers are provided as anatomical markers, i.e. physical properties of a subject that are visible in both X-ray and optical tracking. In a further option, the markers are provided as implants of a subject that are visible in both X-ray and electromagnetic tracking.)
and a region of interest within a patient's anatomy (Fig. 5, Paragraph [0125] – HOLTHUIZEN discloses in FIG. 5, an example is shown, according to which a set of markers 136 is provided, which markers 136 are configured for temporal assignment to the subject 128. As indicated, the set of markers is temporarily assigned to a subject, for example prepared around or outside an area of a planned intervention.);
receive a 3D model of the surgical object (Fig. 3, Paragraph [0153] – HOLTHUIZEN discloses when geometric information is used, such as known size and shape of the markers, the image data can be adapted, i.e. corrected accordingly. As an example, in 2D images, the center point is detected in 3D and models of the markers are used for more detailed location detection. Paragraph [0046-48] – HOLTHUIZEN discloses in a first option, the markers are provided as separate markers that are attached to the subjects, e.g. on the skin of a subject. In a second option, the markers are provided as anatomical markers, i.e. physical properties of a subject that are visible in both X-ray and optical tracking. In a further option, the markers are provided as implants of a subject that are visible in both X-ray and electromagnetic tracking.),
wherein the position of the anchor point is known in the 3D model (Fig. 8, Paragraph [0139] – HOLTHUIZEN discloses FIG. 8 shows an illustration 148 of an example of a registered reconstructed 3D volume for navigation. FIG. 8 shows a side view of the spine structure 144. The spine structure 144 is visible and the markers 136 are also depicted.);
determine a 2D position of the anchor point in the X-ray image (Fig. 3, Paragraph [0099] – HOLTHUIZEN discloses in an identification step 206, the markers in the 2D X-ray images are identified based on image data of the plurality of 2D X-ray images. Paragraph [0130] – HOLTHUIZEN further discloses markers 136 are provided to be detectable in a 2D X-ray image with their respective six degrees of freedom of movement, i.e. their possible location and orientation in space. See also Fig. 3a, Paragraph [0119].);
determine a 3D position of the anchor point in the 3D coordinate system at the first point in time based on (i) the 2D position of the anchor point in the X-ray image (Fig. 1, Paragraph [0045] – HOLTHUIZEN discloses data processor 14 is further configured to register the reconstructed 3D volume of the subject to a current spatial position of the subject based on the detected current spatial location of the markers and the determined spatial location of the markers in relation to the 3D volume of the subject.),
Although HOLTHUIZEN further teaches and (iv) the 3D position of the anchor point in the 3D coordinate system at the first point in time (Fig. 8, Paragraph [0136] – HOLTHUIZEN discloses X-ray visible markers 136 are detected, e.g. automatically, in a subset of the 2D X-ray images, e.g. the first position and the second position) and the detected markers 136 are used to calculate the 3D position of the markers within the extended 3D cone beam CT volume.).
HOLTHUIZEN fails to explicitly teach receive a 3D data set describing the region of interest and defining a 3D coordinate system; and determine an imaging direction onto the region of interest based on the X-ray image, and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time based on (iii) the 3D model of the surgical object,
However, KAY explicitly teaches receive a 3D data set describing the region of interest and defining a 3D coordinate system (Fig. 18-20, Paragraph [0077] – KAY discloses FIGS. 18-20 illustrate how the spiral arrangement of the fiducials in the phantom show up in 2 differing 2D fluoroscopic images, and how these are marked to create the 3D coordinate reference frame that forms part of the 3D coordinate system through which the instrument travels and in which the tracking component of the present system tracks the movement of the instrument along a work-path from one point of interest to a second point of interest. See also Paragraphs [0102-0103].);
and determine an imaging direction onto the region of interest based on the X-ray image (Fig. 9, Paragraph [0073] – KAY discloses the fiducial base 400 is mounted on a pair of guide wires which are implanted into the patient anatomy. And completely within the field of view of the X-ray cone 505 produced by the C-arm X-ray source 501. By using the draw-wire 53 and gimbal base 41 to touch various points 502, 503, and 504, the relative positions and orientation [wherein orientation is direction] of the C-arm, the reference frame mechanical ground 1, global reference frame ground 500, and the patient 4, can all be registered and linked together in a single solid body coordinate system.),
and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time (Fig. 9, Paragraph [0073] – KAY discloses the fiducial base 400 is mounted on a pair of guide wires which are implanted into the patient anatomy. And completely within the field of view of the X-ray cone 505 produced by the C-arm X-ray source 501. By using the draw-wire 53 and gimbal base 41 to touch various points 502, 503, and 504, the relative positions and orientation of the C-arm, the reference frame mechanical ground 1, global reference frame ground 500, and the patient 4, can all be registered and linked together in a single solid body coordinate system.)
based on (iii) the 3D model of the surgical object (Fig. 14, Paragraph [0076] – KAY discloses FIGS. 14-20 illustrate an additional embodiment of the fiducial base or phantom 1399 in which the block 1400 is cylinder with holes 1405 that are arranged in a known geometric array, in this case, a spiral which makes a full rotation about the length of the cylindrical block 1400. KAY further discloses the spiral shape of the fiducials allows the system to create a coordinate reference system in 3D from 2D x-rays. See also Paragraph [0077].),
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date the claimed invention was made to combine the teachings of HOLTHUIZEN of having a non-transitory computer readable medium comprising processor-executable instructions for 3D navigation during musculoskeletal surgery based on single 2D X-ray image, the processor-executable instructions when executed on the processor in a device configure the device to: receive an X-ray image generated at a first point in time, wherein the X-ray image is a 2D projection image depicting at least part of a surgical object including an anchor point and a region of interest within a patient's anatomy; receive a 3D model of the surgical object, wherein the position of the anchor point is known in the 3D model; determine a 2D position of the anchor point in the X-ray image; determine a 3D position of the anchor point in the 3D coordinate system at the first point in time based on (i) the 2D position of the anchor point in the X-ray image, and (iv) the 3D position of the anchor point in the 3D coordinate system at the first point in time, with the teachings of KAY of having receive a 3D data set describing the region of interest and defining a 3D coordinate system; and determine an imaging direction onto the region of interest based on the X-ray image, and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time based on (iii) the 3D model of the surgical object.
Wherein HOLTHUIZEN’s non-transitory computer readable medium wherein having receive a 3D data set describing the region of interest and defining a 3D coordinate system; and determine an imaging direction onto the region of interest based on the X-ray image, and (ii) the imaging direction onto the region of interest for determining a 3D position and 3D orientation of the surgical object relative to the region of interest at the first point in time based on (iii) the 3D model of the surgical object.
The motivation behind this modification would have been to provide an enhanced method of 3D medical navigation based on 2D imaging that provides improved accuracy and real time positional information, since both HOLTHUIZEN and KAY relate to methods and systems for medical positional determination, wherein HOLTHUIZEN relates to guidance during a medical intervention, and relates in particular to a system for navigation support, to a navigated X-ray imaging arrangement for medical interventions of a subject; manually performing a registration is avoided, e.g. by using an optically tracked pointer and indicating several points on the patient, which manual registration can be prone to error and is time consuming, and KAY relates to fine precision control of an instrument so as to enable the user to manipulate the instrument in a reference system in 3D space aided by coordinated 2D images taken in differing planes; it can provide both position and angular information simultaneously, and advantageously, sufficiently in ‘real-time” to enable the use during surgery. Please see HOLTHUIZEN (US 20240065773 A1), Paragraph [0057-0059], and KAY (US 20240366238 A1), Paragraph [0002, 0029].
Conclusion
Listed below are the prior arts made of record and not relied upon but are considered pertinent to applicant’s disclosure.
TOLKOWSKY et al. (US 20240298980 A1) - Multiple x-ray images of a skeletal portion are acquired, from which 3D image data of the skeletal portion is generated. First and second x-ray images of a tool and the skeletal portion are acquired from respective first and second views, the first and second views each being similar to a view of one of the multiple x-ray images. During the acquisition of the multiple images the tool was (i) not visible in the multiple images, or (ii) disposed at a different location than the location in which the tool is disposed during the acquisition of the first and second images. A computer processor registers the first and second images to the 3D image data, identifies a location of the tool within the first and second images, and determines the location of the tool with respect to the 3D image data. Other applications are also described....… Fig. 1, Abstract.
JANNA et al. (US 11931107 B1) - Methods, non-transitory computer readable media, and surgical computing devices are disclosed herein for creating a three-dimensional (3D) model based on a plurality of received two-dimensional (2D) medical images containing patient anatomy and a tracking fiducial. Once the 2D images are received, a determination is made regarding any potential processing steps required to put the images into a standard view. Once the images are processed, a user may modify or adjust various factors. Using the size and orientation of the tracking fiducial a 3D virtual model is created based on a repository of known patient data, such as a bone atlas. The 3D virtual model can then be output to a display device and optionally used to facilitate a surgical procedure. The 3D virtual model of patient anatomy can advantageously be generated more quickly and using fewer resources with this technology....… Fig. 1, Abstract.
JOHNSON et al. (US 20240016549 A1) - System and method of registering a medical image of a patient in an imaging space to the patient in a physical space preferably without the use of any embedded radiopaque fiducials in medical images is provided. In one way, intra-op 2D medical images are used to register a pre-op unregistered 3D medical image. The 2D medical images are registered based on simultaneous tracking of the tracking markers on the imaging device and on the patient by a tracking device at the time of image capture. The 2D images are matched to corresponding simulated 2D images generated from the pre-op 3D image volume. Thus, registration of a pre-op 3D image to the patient is accomplished without performing another 3D scan of the patient.....… Fig. 1, Abstract.
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/BEZAWIT NOLAWI SHIMELES/Examiner, Art Unit 2673
/CHINEYERE WILLS-BURNS/Supervisory Patent Examiner, Art Unit 2673
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