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 .
Status of Claims
This Office Action is responsive to the claims filed on 06/10/2025. Claims 4, 6, 13, and 14 have been amended. Claim 21 is newly presented. Claims 1-3 and 15-16 were previously canceled. Claims 4-14 and 17-21 are presently pending in this application.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6, line 1-2: “the step of presenting at least two indicators” should be amended to read “the step of presenting the indicator” to be consistent with the wording in claim 4.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are: image processing system (Claim 4, Line 6) and processing unit (Claim 4, Line 8 and Claim 13, Line 6). The corresponding structure for the image processing system defined within the specification is the combination of an image reconstructor and a computer (Paragraph [0035], Lines 4-6; Fig. 1 #34 and 36) and any functional equivalents. The corresponding structure for the processing unit defined within the specification is a computer (Paragraph [0035], Line 5; Fig. 1 #36) and any functional equivalents.
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.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13, 14, and 17-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13, line 25; and claim 21, line 1 recite the claim limitation “a volume of the 2D image” which is indefinite because it is unclear what the metes and bounds of a volume of a 2D image would be. It is unclear if this volume a volume of the image data used to form the 2D image; OR if this volume is the area of the field of view of 2D image; OR if this volume is a volume of the anatomy depicted in the 2D image. Furthermore, it is unclear how one would compare a 2D volume with a 3D volume. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)); see also Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. Cir. 2014) (holding the claim phrase “unobtrusive manner’ indefinite because the specification did not “provide a reasonably clear and exclusive definition, leaving the facially subjective claim language without an objective boundary’). See MPEP 2173.05 (b) IV. For the purpose of examination, this is understood to mean a volume of the image data used to form the 2D image; OR if this volume is the area of the field of view of 2D image; OR if this volume is a volume of the anatomy depicted in the 2D image. Furthermore, the 2D image volume being larger than the 3D image volume is considered to mean the image data used to form the 2D image is larger than the image data used to form the 3D image; OR the field of view of the 2D image is larger than the 3D image; OR the volume of the anatomy depicted in the 2D image is larger than the 3D image volume.
Claim Rejections - 35 USC § 103
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.
Claims 4, 6, 8, 13, 17, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Achatz (US 20200237326 A1) in view of Hall (US 20150250434 A1).
Regarding claim 4, Achatz teaches a method for providing anatomical orientation information (Paragraph [0009]; a computer-implemented medical method for determining an orientation of an electrode) in conjunction with images provided by an x-ray imaging system (Paragraph [0007]; The disclosed method uses rotational x-rays (e.g. from rotational angiography, cone beam CT, C-arm x-ray)), the method comprising the steps of:
a. providing an x-ray imaging system (Paragraph [0075]; by using a C-arm x-ray apparatus, Fig. 3) comprising:
i. an x-ray source (Paragraph [0007]; rotational x-rays (e.g. from rotational angiography, cone beam CT, C-arm x-ray)), and an x-ray detector alignable with the x-ray source (Paragraph [0007]; rotational x-rays (e.g. from rotational angiography, cone beam CT, C-arm x-ray). On the series of x-ray shots taken while the detector rotates around the head,);
ii. an image processing system (Paragraph [0054]; An embodiment of the computer implemented method is a use of the computer for performing a data processing method. An embodiment of the computer implemented method is a method concerning the operation of the computer such that the computer is operated to perform one, more or all steps of the method) operably connected to the x-ray source and x-ray detector to generate x-ray image data (Paragraph [0050]; wherein the two-dimensional medical imaging apparatus is operably coupled to the at least one computer for allowing the at least one computer to receive, from the two-dimensional medical imaging apparatus, at least one electronic signal corresponding to the rotational image data), the image processing system including a processing unit for processing the x-ray image data from the x-ray detector to form x-ray images, a database operably connected to the processing unit and storing instructions for operation of the processing unit (Paragraph [0055]; The computer for example comprises at least one processor and for example at least one memory in order to (technically) process the data; Paragraph [0054]; An embodiment of the computer implemented method is a method concerning the operation of the computer such that the computer is operated to perform one, more or all steps of the method), and a display operably connected to the image processing system for presenting information to a user (Paragraph [0056]; The computer is preferably operatively coupled to a display device which allows information outputted by the computer to be displayed, for example to a user.); and
an object (Paragraph [0074]; FIG. 2 shows a directional DBS electrode 1 (also called lead)) including at least two radiopaque markers (Paragraph [0074]; The marker band is made of platinum (Pt) or at least of a material (such as an alloy) comprising platinum (Pt), and is more radiopaque than the marker window 5, Fig. 2) within an anatomy of a patient (Paragraph [0080]; such as the patient's head), the object including a proximal end and a distal end (Paragraph [0074]; Paragraph [0010]; basically cylindrical and in one example rigid shape having a distal end pointing towards the interior of a patient's body and a proximal end pointing towards an exterior of a patient's body), and the at least two radiopaque markers identifying and positioned adjacent the proximal end of the object and the distal end of the object (Paragraph [0074]; cylindrical and elongate body on which contacts 2 are disposed; The electrode 1 also comprises an orientation marker 3 comprising a marker band… and is more radiopaque than the marker window; Paragraph [0078]; the material of which the directional contacts 8 are made is differs in radio-opacity from the material of which the slits 7 are made or with which they may be filled; Fig. 2 shows the marker band 3 which is positioned adjacent to the proximal end of the object and the contacts 2 which is positioned adjacent to the distal end of the object);
c. operating the x-ray source to obtain x-ray image data of the object and the anatomy (Paragraph [0014]; rotational image data is acquired which describes (for example, at least one of defines or represents) two-dimensional medical images);
d. determining a position of the at least two radiopaque markers within the anatomy from the x-ray image data (Paragraph [0016]; comparing the image appearance of the electrode in the at least one or each of the two-dimensional medical images to previously acquired and predetermined electrode template data describing constructional data of the electrode (such as at least one of its geometry and the spatial relationship—at least one of position and orientation—between at least one directional contact and the orientation marker));
e. forming one or more x-ray images of the object, the at least two radiopaque markers and the anatomy from the x-ray image data (Paragraph [0075]; the rotational image data may be acquired by imaging the anatomical structure in the patient's body by using a C-arm x-ray apparatus. Then, the image depiction of the electrode 1 (lead) is extracted from the two-dimensional medical images… contains the thinnest depiction of the first part 5 of the marker band; Fig. 3); and
f. presenting an indicator in association with each of the at least two radiopaque markers illustrated within the one or more x-ray images, each of the indicators having differentiable attributes to illustrate the orientation of the object from the proximal end to the distal end within the one or more x-ray images (Paragraph [0078]; The right part of FIG. 4 illustrates that if an x-ray used for generating the two-dimensional medical image may with a finite probability pass through two slits 7 and thus generate a corresponding mark in the two-dimensional image because the material of which the directional contacts 8 are made is differs in radio-opacity from the material of which the slits 7 are made or with which they may be filled. For example, an x-ray passing through two slits 7 may produce a mark indicating translucence compared to the image appearance of the directional contacts 8. Thereby, an additional indication may be received with an accuracy of about 60° in the example of FIGS. 1 and 4 whether the rotational orientation determined from the image appearance of the orientation maker is valid or not.),
wherein the step of forming one or more x-ray images consists of:
i. forming at least one 3D image of the object, the at least two radiopaque markers and the anatomy by reconstructing the at least one 3D image from the x-ray image data (Paragraph [0076]; As also shown in FIG. 3, a 3D (three-dimensional) image corresponding to the tomographic image data or the transformed appearance data is acquired; Paragraph [0080]; The method uses images taken by an x-ray system while rotating around an anatomical structure such as the patient's head. A 3D (volumetric) image of the head from any tomographic scanner may be used. Further, an algorithm is used for registering the 2D x-ray images to the 3D image… defines the angle of the lead's orientation marker with respect to the image plane); and
forming a 2D image of the object, the at least two radiopaque markers and the anatomy from the x-ray image data (Paragraph [0075]; the rotational image data may be acquired by imaging the anatomical structure in the patient's body by using a C-arm x-ray apparatus. Then, the image depiction of the electrode 1 (lead) is extracted from the two-dimensional medical images (2D x-ray images/radiographies), for example by applying a segmentation algorithm to the two-dimensional medical images),
wherein the step of presenting the indicator comprises:
a. presenting the indicator on the at least one 3D image in association with each of the at least two radiopaque markers (Paragraph [0087]; The directional lead has slits between the segmented contacts which are visible in x-rays at certain angles. These can be used additionally in order to improve angle precision; Paragraph [0088]; Leads can be either segmented by an algorithm in the x-rays or in the 3D image); and
b. presenting the indicator on the 2D image in association with each of the at least two radiopaque markers (Paragraph [0078]; The right part of FIG. 4 illustrates that if an x-ray used for generating the two-dimensional medical image may with a finite probability pass through two slits 7 and thus generate a corresponding mark in the two-dimensional image because the material of which the directional contacts 8 are made is differs in radio-opacity from the material of which the slits 7 are made or with which they may be filled. For example, an x-ray passing through two slits 7 may produce a mark indicating translucence compared to the image appearance of the directional contacts 8).
Achatz does not explicitly teach the method comprises positioning the object within the anatomy of the patient.
Hall, however, teaches a method (Paragraph [0006]; a method for positioning a guide wire within a subject comprises displaying a static X-ray image comprising at least a tip of a guide wire and vessels indicated by contrast.) comprises positioning the object within the anatomy of the patient (Paragraph [0024]; The foreign object may be any object inserted into the body such as a guide wire, a tip of the guide wire, or a catheter.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Achatz to have included the step of positioning the object within the anatomy of the patient because it would have been a well known and understood method would inserting the object into the patient and thereby allow tracking of the object within the patient and further perform an interventional procedure at the target location (Hall, Paragraph [0036]).
Regarding claim 6, together Achatz and Hall teach all of the limitations of claim 4 as noted above.
Achatz further teaches step of presenting at least two indicators representing the radiopaque markers on the one or more x-ray images comprises:
a. presenting the at least one 3D image with the indicator on the display (Paragraph [0087]; The directional lead has slits between the segmented contacts which are visible in x-rays at certain angles. These can be used additionally in order to improve angle precision; Paragraph [0088]; Leads can be either segmented by an algorithm in the x-rays or in the 3D image); and
b. presenting the 2D image with the indicator on the display (Paragraph [0078]; the directional contacts 8 are made is differs in radio-opacity from the material of which the slits 7 are made or with which they may be filled. For example, an x-ray passing through two slits 7 may produce a mark indicating translucence compared to the image appearance of the directional contacts 8)
Achatz does not explicitly teach presenting the 2D image adjacent the at least one 3D image.
Hall, however, further teaches presenting the 2D image adjacent the at least one 3D image (Paragraph [0018]; By way of example, images acquired using the X-ray fluoroscopic system 106 may be displayed as a first image 118 and images acquired using the ultrasound system 122 may be displayed as a second image 120 on the display 116, forming a dual display configuration. In another embodiment, two side-by-side monitors (not shown) may be used.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Achatz in view of Hall to include presenting the 2D image adjacent to the at least one 3D image because it would have allowed a user to more easily recognize and track the position of the object and further allow more easily registering objects between the 3D and 2D images to thereby improve tracking of the object (Paragraph [0031]).
Regarding claim 8, together Achatz and Hall teach all of the limitations of claim 4 as noted above.
Achatz further teaches the x-ray imaging system is a C-arm system (Paragraph [0007]; rotational x-rays (e.g. from rotational angiography, cone beam CT, C-arm x-ray; Fig. 3).
Regarding claim 13, Achatz teaches an x-ray imaging system (Paragraph [0075]; by using a C-arm x-ray apparatus, Fig. 3) comprising:
i. a gantry including an x-ray source (Paragraph [0007]; rotational x-rays (e.g. from rotational angiography, cone beam CT, C-arm x-ray); Fig. 3 shows a gantry with an x-ray source), and an x-ray detector alignable with the x-ray source (Paragraph [0007]; rotational x-rays (e.g. from rotational angiography, cone beam CT, C-arm x-ray). On the series of x-ray shots taken while the detector rotates around the head);
ii. an image processing system operably (Paragraph [0054]; An embodiment of the computer implemented method is a use of the computer for performing a data processing method. An embodiment of the computer implemented method is a method concerning the operation of the computer such that the computer is operated to perform one, more or all steps of the method) connected to the gantry to control operation of the x-ray source and x-ray detector to generate x-ray image data (Paragraph [0050]; wherein the two-dimensional medical imaging apparatus is operably coupled to the at least one computer for allowing the at least one computer to receive, from the two-dimensional medical imaging apparatus, at least one electronic signal corresponding to the rotational image data), the image processing system including a processing unit for processing the x-ray image data from the x-ray detector to form x-ray images, a database operably connected to the processing unit and storing instructions for operation of the processing unit (Paragraph [0055]; The computer for example comprises at least one processor and for example at least one memory in order to (technically) process the data; Paragraph [0054]; An embodiment of the computer implemented method is a method concerning the operation of the computer such that the computer is operated to perform one, more or all steps of the method), a display operably connected to the image processing system for presenting the x- ray images to a user (Paragraph [0056]; The computer is preferably operatively coupled to a display device which allows information outputted by the computer to be displayed, for example to a user.), and a user interface operably connected to the image processing system to enable user input to the processing system (Paragraph [0056]; An augmented reality device can be used both to input information into the computer by user interaction and to display information outputted by the computer.); and
wherein the processing unit is configured to determine a position of at least two radiopaque markers (Paragraph [0016]; comparing the image appearance of the electrode in the at least one or each of the two-dimensional medical images to previously acquired and predetermined electrode template data describing constructional data of the electrode (such as at least one of its geometry and the spatial relationship—at least one of position and orientation—between at least one directional contact and the orientation marker)) located on an object within an anatomy of a patient (Paragraph [0074]; FIG. 2 shows a directional DBS electrode 1 (also called lead); Paragraph [0080]; such as the patient's head), the object including a proximal end and a distal end (Paragraph [0074]; Paragraph [0010]; basically cylindrical and in one example rigid shape having a distal end pointing towards the interior of a patient's body and a proximal end pointing towards an exterior of a patient's body), and the at least two radiopaque markers (Paragraph [0074]; The marker band is made of platinum (Pt) or at least of a material (such as an alloy) comprising platinum (Pt), and is more radiopaque than the marker window 5, Fig. 2) identifying and positioned adjacent the proximal end of the object and the distal end of the object (Paragraph [0074]; cylindrical and elongate body on which contacts 2 are disposed; The electrode 1 also comprises an orientation marker 3 comprising a marker band… and is more radiopaque than the marker window; Paragraph [0078]; the material of which the directional contacts 8 are made is differs in radio-opacity from the material of which the slits 7 are made or with which they may be filled; Fig. 2 shows the marker band 3 which is positioned adjacent to the proximal end of the object and the contacts 2 which is positioned adjacent to the distal end of the object),
to form at least one 3D x-ray image by reconstructing the at least one 3D image of the object, the at least two radiopaque markers and the anatomy from the x-ray image data (Paragraph [0075]; the rotational image data may be acquired by imaging the anatomical structure in the patient's body by using a C-arm x-ray apparatus. Then, the image depiction of the electrode 1 (lead) is extracted from the two-dimensional medical images… contains the thinnest depiction of the first part 5 of the marker band; Fig. 3; Paragraph [0076]; As also shown in FIG. 3, a 3D (three-dimensional) image corresponding to the tomographic image data or the transformed appearance data is acquired; Paragraph [0080]; The method uses images taken by an x-ray system while rotating around an anatomical structure such as the patient's head. A 3D (volumetric) image of the head from any tomographic scanner may be used. Further, an algorithm is used for registering the 2D x-ray images to the 3D image… defines the angle of the lead's orientation marker with respect to the image plane),
to form a 2D x-ray image of the object, the at least two radiopaque markers and the anatomy from the x-ray data (Paragraph [0075]; the rotational image data may be acquired by imaging the anatomical structure in the patient's body by using a C-arm x-ray apparatus. Then, the image depiction of the electrode 1 (lead) is extracted from the two-dimensional medical images (2D x-ray images/radiographies), for example by applying a segmentation algorithm to the two-dimensional medical images), and
to present at least two indicators representing the radiopaque markers at least two different indicators representing in association with the at least two radiopaque markers within each of the at least one 3D x-ray image (Paragraph [0087]; The directional lead has slits between the segmented contacts which are visible in x-rays at certain angles. These can be used additionally in order to improve angle precision; Paragraph [0088]; Leads can be either segmented by an algorithm in the x-rays or in the 3D image) and the 2D x-ray image on the display (Paragraph [0078]; The right part of FIG. 4 illustrates that if an x-ray used for generating the two-dimensional medical image may with a finite probability pass through two slits 7 and thus generate a corresponding mark in the two-dimensional image because the material of which the directional contacts 8 are made is differs in radio-opacity from the material of which the slits 7 are made or with which they may be filled. For example, an x-ray passing through two slits 7 may produce a mark indicating translucence compared to the image appearance of the directional contacts 8), each of the at least two indicators having differentiable attributes to illustrate the orientation of the object from the proximal end to the distal end within the at least one 3D x-ray image and the 2D x-ray image on the display (Figs. 2, 3, and 4 show the electrode on the distal end and the proximal marker have different depictions).
Achatz does not explicitly teach a volume of the 2D image is different than a volume of the 3D image.
Hall, however, teaches a volume of the 2D image (Paragraph [0026]; The fluoroscopic or X-ray images may be displayed as the first image 118 on the display 116; Fig. 4) is different than a volume of the 3D image (Paragraph [0018]; images acquired using the ultrasound system 122 may be displayed as a second image 120 on the display 116; Paragraph [0040]; the ultrasound system 122 and probe 126 may be capable of real-time 3D imaging, also known as 4D imaging. The real-time 3D image data may be displayed on the display 116, such as in a volume, to allow real-time 3D tracking of the guide wire; Paragraph [0037]; a projection 168 (shown on FIG. 4) of the face of the probe 126 may be displayed on the X-ray image 150. The projection 168 is based on the particular probe 126 being used and thus may be a rectangle, as shown, a square or other shape; Fig. 4 shows the volume of the 3D image 120 is different from the volume of the 2D image 118 as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Achatz such that a volume of the 2D image is different than a volume of the 3D image as taught by Hall because it would have allowed getting an enhanced view of the region of interest and more clearly see the region around the tracked portion of the instrument (Paragraph [0042]-[0045]).
Regarding claim 17, together Achatz and Hall teach all of the limitations of claim 13 as noted above.
Achatz further teaches the x-ray imaging system is a C-arm system (Paragraph [0007]; rotational x-rays (e.g. from rotational angiography, cone beam CT, C-arm x-ray; Fig. 3).
Regarding claim 18, together Achatz and Hall teach all of the limitations of claim 17 as noted above.
Achatz further teaches the x-ray imaging system is a CBCT system (Paragraph [0007]; rotational x-rays (e.g. from rotational angiography, cone beam CT, C-arm x-ray; Fig. 3).
Regarding claim 21, together Achatz and Hall teach all of the limitations of claim 13 as noted above.
Achatz does not explicitly teach the 2D image volume is larger than the 3D image volume.
Hall, however, further teaches the 2D image volume is larger than the 3D image volume (Fig. 4 shows that the field of view of the 2D image 118 is larger than the field of view of the 3D image 120 which is considered to read on the claimed limitation as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Achatz in view of Hall such that the 2D image volume is larger than the 3D image volume because it would have allowed getting an enhanced view of the region of interest and more clearly see the region around the tracked portion of the instrument (Paragraph [0042]-[0045]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Achatz in view of Hall as applied to claim 4 above, and further in view of Birenbaum (US 20220022840).
Regarding claim 5, together Achatz and Hall teach all of the limitations of claim 4 as noted above.
The method of Achatz in view of Hall does not teach that the step of forming the 2D image comprises forming a 2D frontal view of the object and the anatomy.
Birenbaum, however, teaches in a similar field of endeavor that the step of forming the 2D image comprises forming a 2D frontal view (Paragraph [0016]; anteroposterior position is a frontal view) of the object and the anatomy (Paragraphs [0013], [0014], [0016], and [0022]; Examiner notes that the live fluoroscopic images are taken from an anteroposterior reference frame).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Achatz in view of Hall such that the step of forming the 2D image comprises forming a 2D frontal view of the object and the anatomy as a location of a target could then be accurately overlaid on a live fluoroscopic image (Birenbaum, Paragraph [0013]).
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Achatz in view of Hall as applied to claims 4 above, and further in view of Warner (US 20170119329).
Regarding claim 7, together Achatz and Hall teach all of the limitations of claim 4 as noted above.
Together Achatz and Hall do not teach that the step of forming the at least one 3D image comprises forming at least one motion-corrected 3D image of the object and the anatomy.
Warner, however, teaches a method for providing anatomical orientation information (Abstract; Paragraph [0018]; an interventional radiology method includes generating an image of anatomy of a patient and a catheter within the anatomy using an imaging system) in conjunction with images provided by an x-ray imaging system (Paragraph [0044]; interventional radiology system, Fig. 1 #100), the method comprising the steps of:
forming one or more x-ray images (Paragraphs [0018]-[0023], [0025], [0044], [0048], and [0050]-[0052]; processing the signals to produce an output #250 of real time 2D or 3D images of the scanned area of the patient #140; The image #165 may provide a 2D or 3D view of a catheter and the patient anatomy through which the catheter is being manipulated) of the object and the anatomy from the x-ray image data (Paragraph [0052]; image, Fig. 5 #165),
wherein the step of forming the at least one 3D image comprises forming at least one motion-corrected 3D image of the object and the anatomy (Paragraph [0054]; image #165 may be processed using one or more of the respiration signals #270 and electrocardiograph signals #275 to provide a stable image unaffected by movement of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Achatz in view of Hall such that forming the at least one 3D image comprises forming at least one motion-corrected 3D image of the object and the anatomy as it would provide a stable image unaffected by movement of the patient or movement associated with the patient's respiration or cardiac activity (Warner, Paragraph [0054]), thus improving the quality of 3D images formed.
Regarding claim 9, together Achatz, Hall, and Warner teach all of the limitations of claim 7 as noted above.
Achatz further teaches the x-ray imaging system is a cone beam computed tomography (CBCT) system (Paragraph [0007]; rotational x-rays (e.g. from rotational angiography, cone beam CT, C-arm x-ray)).
Claims 10, 12, 14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Achatz in view of Hall as applied to claim 4 and 13 above, respectively, and further in view of Erhard (US 20230263487).
Regarding claim 10, together Achatz and Hall teaches all of the limitations of claim 4 as noted above.
Achatz does not explicitly teach the object is a catheter.
Erhard, however, teaches the object is a catheter (Paragraphs [0089]-[0093]; The fiducial marker(s) may be attached to… for example, a catheter in general).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the object of Achatz in view of Hall to have been a catheter as taught by Erhard because it would have allowed tracking the movement of a catheter during an interventional procedure (Erhard, Paragraph [0092]).
Regarding claim 12, together Achatz and Hall teach all of the limitations of claim 4 as noted above.
Achatz does not explicitly teach the object is a stent.
Erhard, however, teaches the object is a stent (Paragraph [0067]; In one example implementation the position of a platinum-coated stent is identified; Paragraph [0094]; an implantable device 220 in the form of a stent that includes a first fiducial marker 1801 and a second fiducial marker 1802).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Achatz in view of Hall such that the object is a stent because it would allow tracking and orienting a stent during a medical operation (Paragraph [0094]-[0095]).
Regarding claim 14, together Achatz and Hall teach all of the limitations of claim 13 as noted above.
Achatz does not explicitly teach the indicators comprise a first indicator having a first color and a second indicator having a second color.
Erhard, however, teaches the at least two indicators comprise a first indicator having a first color and a second indicator having a second color (Paragraphs [0040]-[0042]; For example, the spectral image may discriminate between the first and second materials of the first and second fiducial markers; In general, generating the spectral image may include… color-coding… portions of the spectral image according to the material represented).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the indicators of Achatz in view of Hall to comprise a first indicator having a first color and a second indicator having a second color as further taught by Erhard because it would have allowed discriminating between each of the markers and thereby more accurately determine the position and orientation of the stent (Erhard, Paragraphs [0042] and [0095]).
Regarding claim 19, together Achatz and Hall teach all of the limitations of claim 13 as noted above.
Achatz does not explicitly teach the object is a catheter.
Erhard, however, teaches the object is a catheter (Paragraphs [0089]-[0093]; The fiducial marker(s) may be attached to… for example, a catheter in general).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the object of Achatz in view of Hall to have been a catheter as taught by Erhard because it would have allowed tracking the movement of a catheter during an interventional procedure (Erhard, Paragraph [0092]).
Regarding claim 20, together Achatz and Hall teach all of the limitations of claim 13 as noted above.
Achatz does not explicitly teach the object is a stent.
Erhard, however, teaches the object is a stent (Paragraph [0067]; In one example implementation the position of a platinum-coated stent is identified; Paragraph [0094]; an implantable device 220 in the form of a stent that includes a first fiducial marker 1801 and a second fiducial marker 1802).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Achatz in view of Hall such that the object is a stent because it would allow tracking and orienting a stent during a medical operation (Paragraph [0094]-[0095]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Achatz in view of Hall and Warner as applied to claim 9 above, and further in view of Tolkowsky (US 20120004529 A1).
Regarding claim 11, together Achatz, Hall, and Warner teach all of the limitations of claim 9 as noted above.
Achatz does not explicitly teach the object is a balloon catheter.
Tolkowsky, however, teaches the object is a balloon catheter (Paragraph [0332]; The balloon carrying the stent comprises radio-opaque markers at its proximal and distal ends, the markers being visible under fluoroscopic imaging; Paragraph [0338]-[0339]; A catheter with a balloon and/or stent is inserted to the site of the occlusion, under fluoroscopic imaging. The location of the distal tip of the catheter carrying the balloon and/or stent is visually recognized (such as via display coordinates).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Achatz in view of Hall and Warner such that the object is a balloon catheter as taught by Tolkowsky because it would have allowed positioning a balloon and/or stent is to a site of an occlusion (Paragraph [0338]-[0341] and [0377]).
Response to Arguments
Claim Interpretation under – 35 U.S.C. § 112(f)
Examiner maintains all claim interpretations under 35 U.S.C. § 112(f).
Claim Rejections under – 35 U.S.C. § 112(b)
The amendments to the claims raises new rejections under 35 USC 112(b) which are now presented.
Claim Rejections – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
10/05/25