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
Applicant's arguments below filed 3/3/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
The Applicant asserts on page 9 of the Remarks:
“None of Ben-Haim, Song, Oxley, or Ghosh teach or suggest the method steps of obtaining a structural image of the region of the patient's body via CT and/or MRI techniques, where the structural image comprises three-dimensional image with angiographic contrast enhancement displays an anatomic structure of a vascular network in the region”
In response the examiner respectfully asserts that a cited below Oxley teaches obtaining a structural image of the region of the patient's body via CT and/or MRI techniques, where the structural image comprises […an] image with angiographic contrast enhancement displays an anatomic structure of a vascular network in the region. This can be found in paragraphs [0098] and [0167]. Therefore a new grounds of rejection was made with Oxley teaching this limitation.
Applicants arguments regarding claim 9 are moot in light of the new grounds of rejection
Claim Objections
Claim 1 is objected to because of the following informalities: the third paragraph of claim 1 recites “obtaining a structural image of the region of the patient's body via CT and/or MRI techniques, where the structural image comprises three-dimensional image with angiographic contrast enhancement displays an anatomic structure of a vascular network in the region”. However this should be read as “obtaining a structural image of the region of the patient's body via CT and/or MRI techniques, where the structural image comprises three-dimensional image with angiographic contrast enhancement and displays an anatomic structure of a vascular network in the region”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: claim 1 recites “using the operative map to enable the medical practitioner to identify an implant location for implantation of the electrode array through the vessel in the region of the patient's body; and delivering the electrode array through the vessel; and implanting the electrode array in the region of the patient's body.” However this should be read as “using the operative map to enable the medical practitioner to identify an implant location for implantation of the electrode array through the vessel in the region of the patient's body; delivering the electrode array through the vessel; and implanting the electrode array in the region of the patient's body.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 36 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 36, claim 36 recites “wherein acquiring the real-time three-dimensional image further comprises MRI techniques”. However this limitation is not disclosed in the specification. Paragraphs [0053], [0055], [0057], and [0058] of the current application disclose that the real-time image is a CT image. Therefore the limitation is considered to be new matter.
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 14 and 33 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.
Regarding claim 14, claim 14 recites “wherein implanting the implantable device within the target cortical location comprises advancing the implantable device”. However the implantable device has not been previously defined therefore it is unclear what the implantable device is referring to. Additionally the target cortical location has not been previously defined therefore it is unclear what the target cortical location is referring to. Claim 1 recites “implanting an electrode array” and “identifying a landmark based target” therefore for examination purposes the claim will be interpreted as “wherein implanting the electrode array within the landmark based target comprises advancing the electrode array”.
Claim 33 recites the limitation “the region of neural activity”. There is insufficient antecedent basis for this limitation in the claim. The region of neural activity has not been previously defined therefore for examination purposes the limitation will be interpreted as “a region of neural activity”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-8, 14, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Oxley (US 20140288667) and further in view of Forzoni (US 20160078623), and Hartlep (US 20040138550).
Regarding claim 1, Oxley discloses a method for providing guidance for implanting an electrode array via a vessel in a region of a patient's body ([0097] – “The method may comprise guiding the intravascular device to a region within the vessel proximate the neural tissue to be sensed or stimulated”, [0098] – “The method may comprise visualizing the vessel by a medical imaging technique in order to facilitate guidance”, [0160] – “the electrodes 14 of the intravascular device 4”), the method comprising:
obtaining a structural image of the region of the patient's body via CT and/or MRI techniques, where the structural image comprises […an] image with angiographic contrast enhancement displays an anatomic structure of a vascular network in the region ([0167] – “A radio opaque contrast agent is injected into the blood vessel 6…in order to visualize blood vessels and organs of the body using an imaging technique such as radiography, CT and MR angiography”, MRI would create three-dimensional images);
using the […image] to enable the medical practitioner to identify an implant location for implantation of the electrode array through the vessel in the region of the patient's body ([0098] – “visualizing the vessel by a medical imaging technique in order to facilitate guidance of the intravascular device to the region of the vessel”, [0169] – “stent 20 is threaded up through the catheter 10 to proximate the region where the intravascular device is to be retained”); and
delivering the electrode array through the vessel ([0168] – “The catheter 10 is then threaded into and through the femoral artery, and further up through continuing branches of the femoral artery until it reaches the desired position”, [0169] – “the micro-tube 22 with intravascular device 4 and stent 20 is threaded up through the catheter 10”, [0160] – “the electrodes 14 of the intravascular device 4”); and
implanting the electrode array in the region of the patient's body ([0170] – “The stent 20 is then protruded beyond the proximal end of the micro-tube 22 which has housed it to this point. As the stent 20 is protruded beyond the end of the micro-tube 22 it expands to take on the shape of the blood vessel wall 6, thereby retaining the intravascular device 4 against the inner wall of the vessel 6”, [0160] – “the electrodes 14 of the intravascular device 4”).
Conversely Oxley does not teach where the structural image comprises three-dimensional image
obtaining an activity image of the region of the patient's body, where the activity image displays neural activity of brain tissue in the region via hemodynamic or electrophysiological methods;
co-registering the activity image with the structural image to produce a composite image of the region showing the neural activity displayed in the activity image relative to the anatomic structure of the vascular network of the structural image, thereby identifying a landmark based target;
acquiring a real-time three-dimensional image of the region of the patient's body;
co-registering the composite image with the real-time three-dimensional image such that the landmark based target can be identified using the real-time three-dimensional image to provide an operative map to a medical practitioner;
using the operative map to enable the medical practitioner to identify a […target] location.
However Forzoni discloses where the structural image comprises three-dimensional image (Abstract – “a pre-acquired 3D image”, [0032] – “Pre-acquired images preferably are MRI images. As an alternative or in combination to MRI however it is possible to use also other acquisition modalities such as…CT”)
acquiring a real-time three-dimensional image of the region of the patient's body ([0002] – “acquisition of a first 3D ultrasound image in real-time”, [0040] – “perform a fusion on the basis of the blood vessels of the brain”);
co-registering the […] image with the real-time three-dimensional image such that the landmark based target can be identified using the real-time three-dimensional image to provide an operative map to a medical practitioner (Abstract – “registering the real-time 3D ultrasound image with the pre-acquired 3D image by using the reference pattern or object; fusing the 3D ultrasound images of a sequence of real-time 3D ultrasound images; with the pre-acquired 3D image using data of the co-registration”, [0040] – “perform a fusion on the basis of the blood vessels of the brain”, one with ordinary skill in the art would find it obvious that the real-time registration based on the blood vessels would provide an operative map of the blood vessels, additionally one would find it obvious that the registered functional and structural images of Hartlep could be registered to the real-time ultrasound image to provide real time location of the functional areas of the brain relative to the blood vessels);
using the operative map to enable the medical practitioner to identify a […target] location ([0050] – “the method provides an automatic selection of the Circle of Willis in the 3D ultrasound real-time image, by using the Color Doppler signal, and on the MRI volume”).
Forzoni is an analogous art considering it is in the field imaging blood vessels of the brain.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include the real-time three dimensional image to be registered to the pre-acquired images of Forzoni to achieve the same results. One would have motivation to combine because “The fusion of US with MRI allows the operator to have all the advantages of the two modalities in real time” (Forzoni – [0018]).
Conversely Oxley and Forzoni do not teach obtaining an activity image of the region of the patient's body, where the activity image displays neural activity of brain tissue in the region via hemodynamic or electrophysiological methods;
co-registering the activity image with the structural image to produce a composite image of the region showing the neural activity displayed in the activity image relative to the anatomic structure of the vascular network of the structural image, thereby identifying a landmark based target;
using the […registered image] to enable the medical practitioner to identify a […target] location,
However Hartlep discloses obtaining an activity image of the region of the patient's body, where the activity image displays neural activity of brain tissue in the region via hemodynamic or electrophysiological methods ([0010] – “determining functional anatomical data using functional image detection methods, such as functional magnetic resonance detection and/or positron emission tomography (PET)”, fMRI measures hemodynamic responses, [0019] – “These functional images can be used to determine the area of hypermetabolic activities in the brain”);
co-registering the activity image with the structural image to produce a composite image of the region showing the neural activity displayed in the activity image relative to the anatomic structure of the vascular network of the structural image, thereby identifying a landmark based target ([0020] – “In the next step, namely that of matching 150s, the structural images 140 generated are registered with respect to the functional images 130 in order to provide the spatial position of particular functional cortical areas”, [0021] – “enabling the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown”, one with ordinary skill in the art would find it obvious that when registering with the structural image of Oxley the registration would show the neural activity displayed in the activity image relative to the anatomic structure of the vascular network);
using the […registered image] to enable the medical practitioner to identify a […target] location ([0021] – “enabling the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown on the anatomical images”).
Hartlep is an analogous art considering it is in the field of providing image guidance to navigate a device through the brain.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include obtaining an activity image and co-registering the activity image with the structural image of Hartlep to achieve the same results. One would have motivation to combine because it enables “the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown” (Hartlep – [0021]).
Regarding claim 2, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach where obtaining the activity image comprises performing at least a first non-invasive imaging of the region.
However Hartlep discloses where obtaining the activity image comprises performing at least a first non-invasive imaging of the region (Para [0019] – “image detection includes functional image detection 130, in which functional magnetic resonance detection or positron emission tomography and/or other suitable methods can be used”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include obtaining an activity image of Hartlep to achieve the same results. One would have motivation to combine because it enables “the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown” (Hartlep – [0021]).
Regarding claim 3, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claims 1 and 2.
Conversely Oxley does not teach wherein the first non-invasive imaging of the region comprises an imaging modality selected from the group consisting of functional magnetic resonance imaging (fMRI), MRV, electroencephalogram (EEG), magnetoencephalography (MEG), functional near-infrared spectroscopy (fNIRS), functional positron emission tomography (PET), and any combination thereof.
However Hartlep discloses wherein the first non-invasive imaging of the region comprises an imaging modality selected from the group consisting of functional magnetic resonance imaging (fMRI), MRV, electroencephalogram (EEG), magnetoencephalography (MEG), functional near-infrared spectroscopy (fNIRS), functional positron emission tomography (PET), and any combination thereof (Para [0019] – “image detection includes functional image detection 130, in which functional magnetic resonance detection or positron emission tomography and/or other suitable methods can be used”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include obtaining an activity image of Hartlep to achieve the same results. One would have motivation to combine because it enables “the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown” (Hartlep – [0021]).
Regarding claim 4, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Oxley further discloses where obtaining the structural image comprises performing at least a second non-invasive imaging of the region (Para [0167] – “contrast agent is injected into the femoral artery or internal jugular vein in order to visualize blood vessels and organs of the body using an imaging technique such as radiography, CT and MR angiography”).
Regarding claim 5, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claims 1 and 4.
Oxley further discloses wherein the second non-invasive imaging comprises an imaging modality selected from the group consisting of: structural magnetic resonance imaging (sMRI), magnetic resonance venography (MRV), computed tomography (CT), and any combination thereof (Para [0167] – “contrast agent is injected into the femoral artery or internal jugular vein in order to visualize blood vessels and organs of the body using an imaging technique such as radiography, CT and MR angiography”).
Regarding claim 7, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach where identifying the landmark based target corresponds to the neural activity.
However Hartlep discloses where identifying the landmark based target corresponds to the neural activity (Para [0019] – “functional image detection 130, in which functional magnetic resonance detection or positron emission tomography and/or other suitable methods can be used to establish where the functional cortical areas, to be stimulated, are situated in the patient”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include obtaining an activity image to determine the target location of Hartlep to achieve the same results. One would have motivation to combine because it enables “the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown” (Hartlep – [0021]).
Regarding claim 8, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claims 1 and 5.
Conversely Oxley does not teach wherein the landmark based target comprises a target selected from the group consisting of a target location, a deployment location, a structural landmark, a functional landmark, a structural and functional landmark, a problem area, and any combination thereof.
However Hartlep discloses wherein the landmark based target comprises a target selected from the group consisting of a target location, a deployment location, a structural landmark, a functional landmark, a structural and functional landmark, a problem area, and any combination thereof (Para [0019] – “functional image detection 130, in which functional magnetic resonance detection or positron emission tomography and/or other suitable methods can be used to establish where the functional cortical areas, to be stimulated, are situated in the patient”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include obtaining an activity image to determine the functional landmark target location of Hartlep to achieve the same results. One would have motivation to combine because it enables “the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown” (Hartlep – [0021]).
Regarding claim 14, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Oxley further discloses wherein implanting the implantable device within the target cortical location comprises advancing the implantable device through the vascular network of the patient ([0166] — “The intravascular device 4 may be inserted and retained in the desired region of a vein or artery 6 by performing the following steps:”, [0168] – “the catheter is threaded into branches of the venous system, initially entering the internal jugular vein up through the branches until entering the Superior Sagittal sinus and desired position within the cortical veins”).
Regarding claim 34, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach wherein the hemodynamic or electrophysiological methods are selected from the group of: functional magnetic resonance imaging (fMRI), MRV, electroencephalogram (EEG), magnetoencephalography (MEG), functional near- infrared spectroscopy (fNIRS), functional positron emission tomography (PET), and any combination thereof.
However Hartlep discloses wherein the hemodynamic or electrophysiological methods are selected from the group of: functional magnetic resonance imaging (fMRI), MRV, electroencephalogram (EEG), magnetoencephalography (MEG), functional near- infrared spectroscopy (fNIRS), functional positron emission tomography (PET), and any combination thereof ([0010] – “determining functional anatomical data using functional image detection methods, such as functional magnetic resonance detection and/or positron emission tomography (PET)”, fMRI measures hemodynamic responses, [0019] – “These functional images can be used to determine the area of hypermetabolic activities in the brain”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include obtaining a hemodynamic activity image of Hartlep to achieve the same results. One would have motivation to combine because “using functional image detection, it can be determined which area of the cortex responds” to stimulation (Hartlep – [0019]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley (US 20140288667), Forzoni (US 20160078623), and Hartlep (US 20040138550) as applied to claim 1 above, and further in view of Hladio (US 20190183590).
Regarding claim 9, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach further comprising immobilizing the region of the patient's body prior to acquiring the real-time image.
However, Hladio discloses further comprising immobilizing the region of the patient's body prior to acquiring the real-time image (Para [0070] – “The patient and intra-operative localization system 100 are brought into the operating room; (b) the patient's anatomy 112 (i.e. head) is immobilized via a head-clamp 108”, Para [0108]).
Hladio is an analogous art considering it is in the field of surgical navigation.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include the immobilization of Hladio to achieve the same results. One would have motivation to combine because it would restrict movement of the body and therefore prevent unwanted movements during guidance in the brain that could cause tissue damage.
Claims 15 and 16 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley (US 20140288667), Forzoni (US 20160078623), and Hartlep (US 20040138550) as applied to claim 1 above, and further in view of Ben-Haim (US 20150327805).
Regarding claim 15, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach wherein co-registering the activity image with the structural image further comprises overlaying the activity image with the structural image.
However Ben-Haim discloses wherein co-registering the activity image with the structural image further comprises overlaying the activity image with the structural image (Para [0413] – “The combination may be performed by presenting the functional data side-by-side with, registered with and/or overlaid on the anatomical data”, therefore it is interpreted the images can be registered and presented overlaid).
Ben-Haim is an analogous art considering it is in the field of guiding a catheter using image data.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include overlaying the activity image with the structural image of Ben-Haim to achieve the same results. One would have motivation to combine because it enables one to visualize the structure of the vascular network in relation to the functional areas near each vessel.
Regarding claim 16, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach wherein co-registering the activity image with the structural image further comprises displaying the activity image and the structural image separately side-by-side.
However Ben-Haim discloses wherein co-registering the activity image with the structural image further comprises displaying the activity image and the structural image separately side-by-side (Para [0413] – “The combination may be performed by presenting the functional data side-by-side with, registered with and/or overlaid on the anatomical data”, therefore it is interpreted the images can be registered and presented side-by-side).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include the activity image and the structural image displayed side-by-side of Ben-Haim to achieve the same results. One would have motivation to combine because it enables one to visualize the details structure of the vascular network and functional areas clearly while also seeing positional their relation to one another.
Claims 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Oxley (US 20140288667), Forzoni (US 20160078623), and Hartlep (US 20040138550) as applied to claim 1 above, and further in view of He (CN 101496723B).
Regarding claim 32, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach wherein the activity image is obtained via fMRI techniques, wherein the fMRI technique is configured to acquire one or multiple blood- oxygenation-level-dependent (BOLD) activation locations.
However He discloses wherein the activity image is obtained via fMRI techniques, wherein the fMRI technique is configured to acquire one or multiple blood- oxygenation-level-dependent (BOLD) activation locations (Abstract – “imaging data of a neuro navigation system, which comprises the following steps of: acquiring scanned images in a functional magnetic resonance imaging mode, wherein the functional magnetic resonance imaging mode comprises BOLD scan cortex functional imaging…the registration and fusion comprises the registration mapping of BOLD activation maps”).
He is an analogous art considering it is in the field of imaging for navigation through the brain.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include the BOLD fMRI technique of He to achieve the same results. One would have motivation to combine because “provides a powerful tool for preoperative surgical planning and intraoperative protection of normal brain function, and also provides a platform for brain function research” (He – [0021]).
Regarding claim 33, Oxley, Forzoni, Hartlep and He disclose all the elements of the claimed invention as cited in claims 1 and 32.
Conversely Oxley does not teach wherein the operative map is calculated from the activity image to show the region of neural activity.
However Hartlep discloses wherein the operative map is calculated from the activity image to show the region of neural activity ([0019] – “functional image detection 130…to establish where the functional cortical areas, to be stimulated, are situated in the patient”, [0021] – “enabling the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown on the anatomical images 160…the navigation system is capable of detecting the spatial position of the coil and the head 170 and detecting and displaying the actual and planned position of maximum stimulation, in order to guide a physician carrying out the treatment to the correct stimulation area (the target area)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include obtaining an activity image and co-registering the activity image with the structural image for navigation of Hartlep to achieve the same results. One would have motivation to combine because it enables “the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown” (Hartlep – [0021]).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley (US 20140288667), Forzoni (US 20160078623), and Hartlep (US 20040138550) as applied to claim 1 above, and further in view of Pescatore (US 20080247616).
Regarding claim 35, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach further comprising identifying a functional target overlaid or underlaid onto the activity image and/or the three-dimensional image.
However Hartlep discloses further comprising identifying a functional target […in] the activity image and/or the three-dimensional image ([0019] – “functional image detection 130, in which functional magnetic resonance detection or positron emission tomography and/or other suitable methods can be used to establish where the functional cortical areas, to be stimulated, are situated in the patient”).
Conversely Oxley and Hartlep do not teach a […] target overlaid or underlaid onto the […] image.
However Pescatore discloses a […] target overlaid or underlaid onto the […] image ([0030] – “The act 440 can include superimposing a graphical representation (e.g., a circle, a square, a triangle, or other geometric form) of the ROI 445”).
Pescatore is an analogous art considering it is in the field of image-guided procedures.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include the target overlaid onto the image of Pescatore to achieve the same results. One would have motivation to combine because “The system 100 may also be employed by neurosurgeons in performing cranial surgeries so as to reduce risk to motor, speech, and somato-sensory areas” (Pescatore – [0029]).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley (US 20140288667), Forzoni (US 20160078623), and Hartlep (US 20040138550) as applied to claim 1 above, and further in view of Maraghoosh (US 20160217560).
Regarding claim 36, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach wherein acquiring the real-time three-dimensional image further comprises MRI techniques.
However Maraghoosh discloses wherein acquiring the real-time three-dimensional image further comprises MRI techniques ([0026] – “the preoperative anatomical image and the intraoperative anatomical image may be…preoperative MRI-intraoperative MRI”, [0009] – “live registration of the preoperative-to-intraoperative anatomical images”, it is well known to one with ordinary skill in the art that an MRI scanner can produce three dimensional images, additionally paragraph [0004] discloses the reconstruction of 2D ultrasounds into a 3D volume to be registered with CT or MR therefore it would be obvious to one with ordinary skill in the art to acquire MRI images in 3D).
Maraghoosh is an analogous art considering it is in the field of images that can be used for image-guided procedures.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include the real-time MRI of Maraghoosh to achieve the same results. One would have motivation to combine because it would provide high definition imaging for real-time registration.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley (US 20140288667), Forzoni (US 20160078623), and Hartlep (US 20040138550) as applied to claim 1 above, and further in view of Song et al. NPL 2015 "Basic Three-Dimensional Postprocessing in Computed Tomographic and Magnetic Resonance Angiography".
Regarding claim 37, Oxley, Forzoni, and Hartlep disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oxley does not teach wherein co-registering the activity image with the structural image further comprises creating a target MRI image that can be sliced in any direction according to an acquisition direction of the CT imaging.
However Hartlep discloses wherein co-registering the activity image with the structural image further comprises […] MRI image […and] CT imaging ([0019] – “functional image detection 130, in which functional magnetic resonance detection or positron emission tomography and/or other suitable methods can be used”, [0020] – “structural images of the patient are produced 140, for example, using…CT…the structural images 140 generated are registered with respect to the functional images 130”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include co-registering the activity image with the structural image of Hartlep to achieve the same results. One would have motivation to combine because it enables “the optimal stimulation point to be planned and an image of the functional areas and the stimulation area to be shown” (Hartlep – [0021]).
Conversely Oxley and Hartlep do not teach creating a target MRI image that can be sliced in any direction according to an acquisition direction of the CT imaging.
However Song discloses creating a target MRI image that can be sliced in any direction according to an acquisition direction of the CT imaging (Song teaches multiplanar reformation in FIGURE 83-1 where a three dimensional image such as MRI can be sliced in any direction including an oblique direction. Therefore one with ordinary skill in the art would find it obvious to slice an MRI in a direction for it to correlate with the structural CT image of Hartlep),
Song is an analogous art considering it is in the field of providing MRI images to view vessels.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Oxley to include the slicing of images of Song to achieve the same results. One would have motivation to combine because "it is particularly useful for showing vascular detail in cross-sectional profile along the vessel length" (Song - Multiplanar Reformation).
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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/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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