DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The claim objections have been withdrawn in light of the amended claims. However, in light of the amended claims a new rejection under 35 U.S.C. 112(b) has been introduced.
Applicant's arguments filed 5/18/2026 with respect to the rejections under 35 USC 103 have been fully considered but they are not persuasive. On pages 8-9 of Remarks, the Applicant states “First, the Action asserts that image acquisition unit 7 corresponds to the claimed the live imaging device. Janssen teaches that the image acquisition unit 7 comprises a plurality of cameras connected to the CT unit 4, including several cameras 18, 19, 20 positioned for acquiring images of the region outside of the CT scanner 8, and cameras 17, 21 positioned for acquiring images of the patient inside of the CT scanner 4. (See para. 52 and FIGS. 2 and 3.) Accordingly, Janssen fails to disclose or suggest a live imaging device comprising a camera sized and configured for insertion into the patient's body for acquiring live images of an operation site inside the patient's body. It follows that Janssen also fails to disclose a processing unit adapted to register and blend the at least one at least 2-dimensional scan image and the live images of the operation site inside the patient's body according to the data captured during the medical imaging and live imaging. Instead, Janssen uses the externally positioned cameras 17-21 to detect positions of the optical markers 60 attached to the patient to detect movement of the patient. (See para. 56.)”.
The Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Applicant also states “In addition, the Action fails to establish that one of ordinary skill would have been motivated to modify Janssen to incorporate a patient support device comprising at least one deformable element of a malleable material, wherein the malleable material is a curable material, and wherein at least one tracker element is directly connected to the at least one deformable element. The Action argues that Lavallee discloses a patient support device of a malleable curable material in the form of a calibration phantom 48 having a support structure 78 shaped like a frame that is bent such that its curvature substantially matches that of the back of the patient. (Lavallee, Col. 11, line 38 to 41, FIG. 5.) The calibration phantom 48 comprises radiopaque markers 80 attached to the support structure 78 such that they outline the region of interest where X-ray images are to be acquired. The markers 80 of the calibration phantom are used to determine the spatial relation between the acquired X-ray images for producing the three- dimensional image. The Action argues that it would have been obvious to a person of ordinary skill to implement a bent support structure with Janssen's markers attached to it to "distinctly outline a region of interest and prevent residue from contamination other parts of the body." (Action at 9.) However, Janssen already teaches use of a calibration element in the form of a calibration plate 22, which includes a combination of optical markers 23 and CT markers 24 to determine a spatial relation between the field of view of the optical image acquisition unit 7 and the CT unit 4. (See para. 54-55, FIG. 6.) The Action fails to explain why one of ordinary skill would introduce a calibration phantom disclosed in Lavallee when Janssen already discloses use of a specialized calibration plate 22 having both optical markers 23 and CT markers 24 for calibration of its CT unit and optical image acquisition unit 7. Further, since Janssen teaches use of optical markers 60 attached to the skin of the patient in order to detect movement, position and orientation of the patient (para. 68.), it is unclear how the calibration phantom of Lavallee, which appears to rest on a patient's back, would improve the functionality of the optical image acquisition unit 7 to track movement of the patient.”
The examiner would like to note that the modification is taking place in the region of interest and is not exclusively placed in the patient’s back, as shown in the figure. Janssen states in paragraph [0054] “the upper part of the calibration plate 22 should be arranged in the CT imaging region and the lower part of the calibration plate 22 should be arranged in the outside region 8”. Thus, there leaves an opening in the outside region: on top of the patient. The calibration plate comprises of markers that determine a spatial relation between the field of view and the CT image, but they do not extend to the markers 60 that are placed on the patient’s body. Introducing Lavallee is to firmly establish the location of such markers, and it’s use cases lies in situations where doctors want to look inside the patient’s body. As a result, this support structure clearly outlines the part of the patient’s body that needs probing, and prevent contamination by walling the region off from the other parts of the body.
Claim Interpretation
Claims 16 recite wherein the curable material of the at least one deformable element (15) comprises one of a plaster casting material, fiberglass, and a resin- based casting material”. Specification paragraph [0035] states “The deformable elements 15 to 17 may be cushions filled with malleable durable material as there is plaster cast, fiber glass, reinforced plaster cast, resin-based casts or the like”. Since “or” 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. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
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 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), 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f), is rebutted when the claim limitation recites 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), except as otherwise indicated. 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), except as otherwise indicated in this Office action.
Such claim limitation(s) is/are:
“a patient support device (11) adaptive to a shape of the patient's body” in claim 1,
“at least one tracker element (21) connected to the support device (11) and adapted to indicate a position and orientation of the patient support device” in claim 1,
“Means for capturing data (33) indicating a position and/or orientation of the at least one tracker element (21)” in claim 1,
“a medical imaging system (13) adapted to acquire at least one at least 2- dimensional scan image (29) of a patient's region of interest in relation to the position of the at least one tracker element (21)” in claim 1,
“a detection system (35) for capturing data (36) indicating the at least one tracker element's position during surgery” in claim 1,
“and a processing unit (28, 28a) adapted to register and blend the at least one at least 2-dimensional scan image and the live images (29, 42, 52) of the operation site inside the patient’s body according to the data captured during the medical imaging and live imaging” in claim 1;
“wherein the at least one deformable element (15) is open at one side, so that the patient can be removed from and reinserted into the at least one deformable element (15)” in claim 1;
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), they 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), applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
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.
Claims 15 is/are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 15 recites “and registering and blending the at least one at least 2-dimensional scan image and the live images according to the data (36) captured during the medical imaging and live imaging”. It is unclear if the “live images” are the images that correspond to the images “of an operation site inside the patient's body by a live imaging device (39) comprising a camera inserted into the patient's body” as cited in the previous limitation, or another set of images entirely. For examination purposes, the examiner will treat this limitation (similar to claim 1) as “and registering and blending the at least one at least 2-dimensional scan image and the live images of the operation site inside the patient's body according to the data (36) captured during the medical imaging and live imaging”.
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.
Claim(s) 1-2, 8-9, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen (US 20160249984 A1) in view of Suppa (US 20230116388 A1) and Lavallee (US 9610056 B2).
Regarding claim 1, Janssen discloses an arrangement for imaging (10) and surgery (34) on a patient's body (18) (Janssen, paragraph [0037], "FIG. 1 shows schematically and exemplarily a side view of an embodiment of an interventional system comprising a CT system and an interventional instrument in a first situation, in which an object is arranged within a CT imaging region,") comprising:
a patient support device (11) adaptive to a shape of the patient's body (Janssen, paragraph [0044], "In this embodiment the object 5 is a thorax of a patient 31 and the movable support element 9 is a patient table being movable in the longitudinal direction indicated by the double arrow 32", a patient table is adapted to fit the patient),
at least one tracker element (21) connected to the patient support device (11) and adapted to indicate a position and orientation of the patient support device (11) (Janssen, paragraph [0056], "Optical markers 60 are attached to the object 5, wherein the optical image acquisition unit 7 is adapted to acquire motion measurement optical images showing the optical markers 60 at different times, wherein the processing unit 2 further comprises an object motion determination unit 25 for determining object motion relative to the movable support element 9 based on the acquired motion measurement optical images", there is a connection between the markers at different times and the support element in the optical images and they are used to determine a position of the support element),
means for capturing data (33) indicating a position and/or orientation of the at least one tracker element (21) (Janssen, paragraph [0053], "The moving distance determination unit 15 is adapted to detect the positions of the optical markers 14 in the first and second distance measurement optical images and to determine the moving distance based on the detected position"),
a medical imaging system (13) adapted to acquire at least one at least 2- dimensional scan image (29) of a patient's region of interest in relation to the position of the at least one tracker element (21) (Janssen, paragraph [0055], "In the calibration step the calibration plate 22 is arranged in the CT imaging region 6 and in the outside region 8 and the computed tomography image generating unit 4 generates a calibration CT image of the calibration plate 22 in the CT imaging region 6. Moreover, the optical image acquisition unit 7 acquires calibration optical images of the calibration plate 22 within the CT imaging region 6 and within the outside region 8. The spatial relation providing unit 11 then detects the positions of the optical markers 23 in the calibration optical images and the positions of the CT markers 24 in the calibration CT image and determines a spatial relation between the field of view of the computed tomography image generating unit 4 and the field of view of the optical image acquisition unit 7 based on the determined positions.", when taking a CT image, there will be trackers in the image),
a detection system (35) for capturing data (36) indicating the at least one tracker element's position during surgery (Janssen, paragraph [0056], "Optical markers 60 are attached to the object 5, wherein the optical image acquisition unit 7 is adapted to acquire motion measurement optical images showing the optical markers 60 at different times, wherein the processing unit 2 further comprises an object motion determination unit 25 for determining object motion relative to the movable support element 9 based on the acquired motion measurement optical images"),
a live imaging device (39) comprising a camera sized and configured for insertion into the patient's body for acquiring live images (42) of an operation site inside the patient's body (Janssen, paragraph [0046], "FIGS. 1 and 3 further show an interventional instrument 26 like a catheter or a needle connected to an interventional instrument control unit 33. The interventional control unit 33 can be adapted, for instance, to provide energy to be applied inside the object 5, to receive sensing signals from the interventional instrument 26 like temperature signals, imaging signals, et cetera and to process these signals for determining a property of the inside of the object, et cetera.").
While Janssen teaches and a processing unit (28, 28a) adapted to register and blend the at least one at least 2- dimensional scan image and the live images (29, 42, 52) according to the data captured during the medical imaging and live imaging (Janssen, paragraph [0047], "The processing unit 2 further comprises a spatial relation providing unit 11 for providing a spatial relation between a field of view of the computed tomography image generating unit 4 and a field of view of the optical image acquisition unit 7 and an image fusion unit 12 for generating a fusion image, in which the CT image and the optical image are fused and which also shows the provided path, based on the CT image, the optical image, the provided path, the provided spatial relation and the moving distance."), they do not teach the blending the 2-dimensional scan image and the live images (42) of the operation site inside the patient’s body.
However, Suppa teaches a processing unit (28, 28a) adapted to register and blend the at least one at least 2- dimensional scan image and the live images (29, 42, 52) of the operation site inside the patient's body according to the data captured during the medical imaging and live imaging (Suppa, paragraph [0003], “ Image registration is used for example in medical imaging to align and overlay a preoperative image, for example a computer tomography (CT) image or a magnetic resonance (MR) image, onto an intraoperative image, for example an intraoperative laparoscopic video image.”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to image register Janssen’s catheter images with their 2-D scan image, as taught by Suppa.
The suggestion/motivation for doing so would have been to generate more angles and images of the patient’s insides for a thoroughly complete scan.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Janssen in view of Suppa does not teach “wherein the patient support device (11) comprises at least one deformable element (15) of a malleable material (15a), and wherein the malleable material is a curable material (15a)”.
However, Lavallee teaches wherein the patient support device (11) comprises at least one deformable element (15) of a malleable material (15a), and wherein the malleable material is a curable material (15a) (Lavallee, Col. 11, Lines 38-45, Fig. 5 below, " FIG. 5 schematically illustrates a preferred embodiment of calibration phantom 48 with a support structure 78 shaped like a frame being bended such that its curvature substantially matches that of the back of a patient 50. The principle can be extended to any anatomical part of a body in order to fit its external shape. In this case, the abovementioned attachment fixture may be omitted. Radiopaque markers 80 are attached to support structure 78").
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It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to implement a bended support structure with Janssen’s (in view of Suppa) markers attached to it, as taught by Lavallee.
The suggestion/motivation for doing so would have been to distinctly outline a region of interest and prevent residue from contaminating other parts of the body.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Janssen in view of Suppa and Lavallee discloses wherein the at least one deformable element (15) is open at one side, so that the patient can be removed from and reinserted into the at least one deformable element (15) (Lavallee, Col. 11, Lines 45-50, "The advantage of this phantom design is the fact that the Region Of Interest (ROI) is surrounded by radiopaque markers while keeping the ROI itself free, thus allowing unobstructed surgical access to the ROI by the surgeon while maximizing the number of markers being close to the ROI and imaged during the scan.", the bendable material is open on one side),
and wherein at least one tracker element (21) is directly connected to the at least one deformable element (15) (Lavallee, Col. 11, Lines 44-45, "Radiopaque markers 80 are attached to support structure 78").
Therefore, it would have been obvious to combine Janssen in view of Suppa and Lavallee to obtain the invention as specified in claim 1.
Regarding claim 2, Janssen in view of Suppa and Lavallee discloses the arrangement of claim 1, wherein the patient support device (11) includes a movable table (14, 14a) (Janssen, paragraph [0044], "In this embodiment the object 5 is a thorax of a patient 31 and the movable support element 9 is a patient table being movable in the longitudinal direction indicated by the double arrow 32.").
Regarding claim 8, Janssen in view of Suppa and Lavallee discloses the arrangement according to claim 1, wherein the at least one deformable element (15, 16, 17) comprises a window (49) for giving access to the patient (Lavalle, Col. 11, Line 38-41, Fig. 5 below, "FIG. 5 schematically illustrates a preferred embodiment of calibration phantom 48 with a support structure 78 shaped like a frame being bended such that its curvature substantially matches that of the back of a patient 50", there is an opening in the middle).
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Regarding claim 9, Janssen in view of Suppa and Lavallee discloses the arrangement of claim 1, comprising an instrument (44) for treating the patient's body (18) in the region of interest (41) (Janssen, paragraph [0048], "The optical image acquisition unit 7 is preferentially adapted to acquire an actual time-pendent live optical image of the object 5 within the outside region 8 in the situation illustrated in FIG. 3, when the interventional instrument 26 is placed on and optionally already inserted into the object 5").
Regarding claim 12, Janssen in view of Suppa and Lavallee discloses the arrangement of claim 1, wherein the detection system comprises at least two cameras (37, 38) for trigonometrically determining the position and the orientation of the at least one tracker element (21) in space (Janssen, paragraph [0052], Fig. 1 below, "In addition, the optical image acquisition unit 7 comprises cameras for acquiring optical images of the object 5 within the CT imaging region 6").
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Regarding claim 17, Janssen in view of Suppa and Lavallee discloses the arrangement of claim 1, further comprising a tracker element connected to the live imaging device to allow the detection system (35) to detect a location and orientation of the camera of the live imaging device (39) (Janssen, paragraph [0051], "The fusion image 40 further shows the provided path 43, i.e. a corresponding graphical representation 43, and the actual position and orientation of the interventional instrument 26 held by a hand 44 of a physician").
Claim(s) 3 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen (US 20160249984 A1) in view of Suppa (US 20230116388 A1), Lavallee (US 9610056 B2) and in further view of Beyers (EP 3278759 A1).
Regarding claim 3, Janssen in view of Suppa and Lavallee discloses the arrangement of claim 1.
Janssen in view of Suppa and Lavallee does not teach “wherein the patient support device (11) is adaptive to the shape of the patient's body by 3D-printing at least one element (15) according to a scan of at least a part of an outer shape of the patient's body”.
However, Beyers teaches wherein the patient support device (11) is adaptive to the shape of the patient's body by 3D-printing at least one element (15) according to a scan of at least a part of an outer shape of the patient's body (Beyers, paragraph [0024], Line 14-24, “In some embodiments, custom molded or 3-D printed devices 250 can be created for each patient to be worn during a procedure. To create such devices 250, preoperative scans are taken of a surgical site and custom fit devices 250 would be manufactured to be placed on the patient. In one such non-limiting example, as is shown in FIG. 3, for a brain surgery, a helmet 250 is custom manufactured for patient 200 and includes attachment portions 252 that provide a coupling point for components 112 as well as apertures 254 for performing the procedure,”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to scan Janssen’s (in view of Suppa and Lavallee) body and create a 3d mold, as taught by Beyers.
The suggestion/motivation for doing so would have been to provide more secure and extra immobilization.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Janssen in view of Suppa, Lavallee and in further view of Beyers to obtain the invention as specified in claim 3.
Claim(s) 7 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen (US 20160249984 A1) in view of Suppa (US 20230116388 A1), Lavallee (US 9610056 B2), and in further view of Ahn (US 9433387 B2).
Regarding claim 7, Janssen in view of Suppa and Lavallee discloses the arrangement of claim 1.
While Janssen in view of Suppa and Lavallee discloses a deformable element as described in claim 1, they do not teach “wherein the support device comprises at least two deformable elements (15, 16, 17) embracing at least a portion of the patient”.
However, Ahn teaches wherein the support device comprises at least two deformable elements (15, 16, 17) embracing at least a portion of the patient (Ahn, Col. 21-22, Line 64-67, 1-9, “A Vac-Lok, alpha-cradle or other mold 25 may be conformed to the posterior contours of the body. A set of sensor grid(s) 16/18/22 or sensor strips(s) is incorporated into the flexible shell of the mold at time of manufacture or added on by the user prior to use by the patient. Alternatively, a flat sensor grid 16/18 may be placed directly on the table behind the patient without the use of a mold. For additional immobilization, there is the option of wrapping a commercially available, plastic or other flexible material 36 around the patient, with a vacuum seal created that encompasses the anterior part of the body and immobilizes it via compression such as with the BodyFix system,”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to implement a mold that fits Janssen’s (in view of Suppa and Lavallee) patient’s body, as taught by Ahn.
The suggestion/motivation for doing so would have been to provide more secure and extra immobilization.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Janssen in view of Suppa, Lavallee, and in further view of Ahn to obtain the invention as specified in claim 7.
Claim(s) 11 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen (US 20160249984 A1) in view of Suppa (US 20230116388 A1), Lavallee (US 9610056 B2), and in further view of Weinstein (US 11707330 B2).
Regarding claim 11, Janssen in view of Suppa and Lavallee discloses the arrangement of claim 1.
Janssen in view of Suppa and Lavallee does not teach “wherein the at least one tracker element (21) comprises spaced apart reflector elements detectable by the detection system”.
However, Weinstein teaches at least one tracker element comprises spaced apart reflector elements detectable by the detection system (Weinstein, Col. 5, Line 57-61, “In this embodiment, each tracker 44, 46, 48 has at least three passive tracking elements or markers (e.g., reflectors) for transmitting light signals (e.g., reflecting light emitted from the camera unit 36) to the optical sensors 40,”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to add reflective trackers on Janssen’s (in view of Suppa and Lavallee) patient’s body, as taught by Weinstein.
The suggestion/motivation for doing so would have been to allow surgeons to visualize and navigate the position of their instruments, thus providing them more information and improving their surgical accuracy.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Janssen in view of Suppa, Lavallee, and in further view of Weinstein to obtain the invention as specified in claim 11.
Claim(s) 14 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen (US 20160249984 A1) in view of Suppa (US 20230116388 A1), Lavallee (US 9610056 B2), and in further view of Ryu (US 20120099012 A1).
Regarding claim 14, Janssen in view of Suppa and Lavallee discloses the arrangement of claim 1.
Janssen in view of Suppa and Lavallee does not teach “wherein the detection system (35) is configured for detecting a location and orientation of the camera (39) of the live imaging device”.
However, Ryu teaches wherein the detection system (35) is configured for detecting a location and orientation of the at least one camera (39) of the live imaging device (Ryu, paragraph [0125], “The controller 401 acquires (receives) an image (e.g., reference image) corresponding to the detected current location (location information) and the capturing direction (S34). For instance, the controller 401 detects current location information through the location detection unit 404 and a capturing direction of the camera 405 when a capturing mode of the camera 405 is selected by a user,”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to detect Janssen (in view of Suppa and Lavallee) camera’s location and orientation using Ryu’s controller.
The suggestion/motivation for doing so would have been make sure all cameras are properly set so that the surgeon can have a consistent view of the patient.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to Janssen in view of Suppa and Lavallee and in further view of Ryu to obtain the invention as specified in claim 14.
Claim(s) 15 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen (US 20160249984 A1) in view of Lavallee (US 9610056 B2), Cohen (US 10966799 B1), and Suppa (US 20230116388 A1).
Regarding claim 15, Janssen discloses a method of image registering (Janssen, paragraph [0005], “It is a further object of the present invention to provide an interventional system comprising the CT system and to provide a fusion image generation method and computer program for generating a fusion image, which allow for a reduction of the number of object movements and of the applied radiation dose during an interventional procedure guided by the CT system”),
adapting a patient support device (11) to a shape of a patient's body (18) (Janssen, paragraph [0044], "In this embodiment the object 5 is a thorax of a patient 31 and the movable support element 9 is a patient table being movable in the longitudinal direction indicated by the double arrow 32", a patient table is adapted to fit the patient).
Janssen does not teach “wherein the patient support device (11) comprises at least one deformable element (15) of a malleable material (15a), and wherein the malleable material is a curable material (15a) and wherein the malleable material is a curable material (15a), wherein the at least one deformable element (15) is open at one side, so that the patient can be removed from and reinserted into the at least one deformable element (15);”.
However, Lavallee teaches wherein the patient support device (11) comprises at least one deformable element (15) of a malleable material (15a), and wherein the malleable material is a curable material (15a) and wherein the malleable material is a curable material (15a), wherein the at least one deformable element (15) is open at one side, so that the patient can be removed from and reinserted into the at least one deformable element (15) (Lavallee, Col. 11, Lines 38-45, Fig. 5 below, " FIG. 5 schematically illustrates a preferred embodiment of calibration phantom 48 with a support structure 78 shaped like a frame being bended such that its curvature substantially matches that of the back of a patient 50. The principle can be extended to any anatomical part of a body in order to fit its external shape. In this case, the abovementioned attachment fixture may be omitted. Radiopaque markers 80 are attached to support structure 78").
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It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to implement a bended support structure with Janssen’s markers attached to it, as taught by Lavallee.
The suggestion/motivation for doing so would have been to distinctly outline a region of interest and prevent residue from contaminating other parts of the body.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Janssen in view of Lavallee does not teach “curing the at least one deformable element (15) of the patient support device (11)”.
However, Cohen teaches curing the at least one deformable element (15) of the patient support device (11) (Cohen, Col. 2, Line 50-53, “In certain embodiments, the housing includes arm extensions that are each configured to urge the flowable or malleable material to harden in an undercut of the one or the plurality of teeth to stabilize the system.”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to cure the deformable element of Janssen (in view of Lavallee), as taught by Cohen.
The suggestion/motivation for doing so would have been to ensure the material is hardened, resulting in secure mobilization of the patient.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Janssen in view of Lavallee and Cohen discloses connecting at least one tracker element (21) to the patient support device (11) and capturing data indicating a position and/or orientation of the at least one tracker element (21) (Janssen, paragraph [0056], "Optical markers 60 are attached to the object 5, wherein the optical image acquisition unit 7 is adapted to acquire motion measurement optical images showing the optical markers 60 at different times, wherein the processing unit 2 further comprises an object motion determination unit 25 for determining object motion relative to the movable support element 9 based on the acquired motion measurement optical images", there is a connection between the markers at different times and the support element in the optical images and they are used to determine a position of the support element),
acquiring at least one at least 2-dimensional scan image (29) of a patient's region of interest (41) in relation to the position of the at least one tracker element (21) with a medical imaging system (13) (Janssen, paragraph [0055], "In the calibration step the calibration plate 22 is arranged in the CT imaging region 6 and in the outside region 8 and the computed tomography image generating unit 4 generates a calibration CT image of the calibration plate 22 in the CT imaging region 6. Moreover, the optical image acquisition unit 7 acquires calibration optical images of the calibration plate 22 within the CT imaging region 6 and within the outside region 8. The spatial relation providing unit 11 then detects the positions of the optical markers 23 in the calibration optical images and the positions of the CT markers 24 in the calibration CT image and determines a spatial relation between the field of view of the computed tomography image generating unit 4 and the field of view of the optical image acquisition unit 7 based on the determined positions.", when taking a CT image, there will be trackers in the image),
capturing data (36) indicating the at least one tracker element's position during surgery by means of a detection system (35) (Janssen, paragraph [0056], "Optical markers 60 are attached to the object 5, wherein the optical image acquisition unit 7 is adapted to acquire motion measurement optical images showing the optical markers 60 at different times, wherein the processing unit 2 further comprises an object motion determination unit 25 for determining object motion relative to the movable support element 9 based on the acquired motion measurement optical images"),
acquiring live images (42) of an operation site inside the patient's body by a live imaging device (39) comprising a camera inserted into the patient's body (Janssen, paragraph [0046], "FIGS. 1 and 3 further show an interventional instrument 26 like a catheter or a needle connected to an interventional instrument control unit 33. The interventional control unit 33 can be adapted, for instance, to provide energy to be applied inside the object 5, to receive sensing signals from the interventional instrument 26 like temperature signals, imaging signals, et cetera and to process these signals for determining a property of the inside of the object, et cetera.").
While Janssen in view of Lavallee and Cohen teaches and registering and blending the at least one at least 2-dimensional scan image and images according to the data (36) (Janssen, paragraph [0047], "The processing unit 2 further comprises a spatial relation providing unit 11 for providing a spatial relation between a field of view of the computed tomography image generating unit 4 and a field of view of the optical image acquisition unit 7 and an image fusion unit 12 for generating a fusion image, in which the CT image and the optical image are fused and which also shows the provided path, based on the CT image, the optical image, the provided path, the provided spatial relation and the moving distance."), they do not teach “registering and blending the at least one at least 2-dimensional scan image and the live images according to the data (36) captured during the medical imaging and live imaging”*.
*as stated in the rejection under 35 U.S.C. 112(b), the limitation is being treated as blending the 2-D scan image along with the live images of the operation site inside the patient's body (similar to claim 1). If the Applicant intended for a different meaning, they are invited to clarify or amend such limitation.
However, Suppa teaches and registering and blending the at least one at least 2-dimensional scan image and the live images according to the data (36) captured during the medical imaging and live imaging. (Suppa, paragraph [0003], “Image registration is used for example in medical imaging to align and overlay a preoperative image, for example a computer tomography (CT) image or a magnetic resonance (MR) image, onto an intraoperative image, for example an intraoperative laparoscopic video image.”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to image register Janssen’s (in view of Lavallee and Cohen) catheter images with their 2-D scan image, as taught by Suppa.
The suggestion/motivation for doing so would have been to gain angles and images of the patient’s insides for a thoroughly complete scan.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Janssen in view of Lavallee, Cohen, and Suppa to obtain the invention as specified in claim 15.
Claim(s) 16 are rejected under 35 U.S.C. 103 as being unpatentable over Janssen (US 20160249984 A1) in view of Suppa (US 20230116388 A1), Lavallee (US 9610056 B2), and in further view of Sayler (US 20150230871 A1).
Regarding claim 16, Janssen in view of Suppa and Lavallee discloses the arrangement of claim 1.
Janssen in view of Suppa and Lavallee does not explicitly teach “wherein the curable material of the at least one deformable element (15) comprises one of a plaster casting material, fiberglass, and a resin- based casting material”.
However, Sayler teaches wherein the curable material of the at least one deformable element (15) comprises one of a plaster casting material, fiberglass, and a resin- based casting material (Sayler, paragraph [0104], “Components of the frame assembly 10 and/or positioning device 200 can be formed from any suitable material, typically a light-weight relatively rigid polymeric material, such as, for example, fiberglass, ceramics, fiber reinforced resins, PEEK, ABS, polycarbonate, KEVLAR, and/or Garolite”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to have Janssen’s (in view of Suppa and Lavallee) deformable element made from fiberglass, as taught by Sayler.
The suggestion/motivation for doing so would have been because fiberglass is lightweight and durable, allowing for secure mobilization without weighing down the patient.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Janssen in view of Suppa, Lavallee, and in further view of Sayler to obtain the invention as specified in claim 16.
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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/WAYNE ZHANG/Examiner, Art Unit 2672
/SUMATI LEFKOWITZ/Supervisory Patent Examiner, Art Unit 2672
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