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 .
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 limitation(s) is/are: “a tool operable to stimulate…” in claim 1; “a nerve monitoring control system for receiving signals…” in claim 1; “image processing system is operable to generate fluoroscopic images…” in claim 1; “image processing system…to correlate the fluoroscopic image…” in claim 1; and “the image processing system is operable to identify…” in claim 2. Par. [0013] discusses software (computer).
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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 102161701 B1 to Hoon in view of US 2008/028377 A1 to Li.
Claim 1. Hoon teaches A system for visualizing a surgical site within the brain of a patient, [page 1] MRI the actual visible location corresponds to, while performing surgery
[page 1] displays a three-dimensional nerve image by mapping a functional cerebral nerve image by reconstructing the position in a three-dimensional space through a nerve navigation device.
including identifying and keeping track of nerves within the brain, said system comprising: [page 1] neuronavigation is used to accurately identify the location of structures during brain surgery
[page 9] the neural monitoring unit 200 includes a signal detection unit 220, the signal detection unit 220 receives the electrical response signal received from the detector 210
a nerve monitoring system comprising a tool operable to stimulate a nerve within the brain, [page 1] when the probe 110 of the nerve stimulation unit 100 is brought into contact with the corresponding head, when the stimulation emitted from the probe 110 is applied, the region to which the stimulation is applied is displayed as a three-dimensional brain nerve image on the display unit.
[page 1] At this time, if the response to the stimulus is positive (+) in the 3D cranial nerve image, the cranial nerve is displayed in red, if it is negative (-), the cranial nerve is displayed in blue, and the cranial nerve displayed in red depends on the intensity of the response to the stimulus.
a response sensor operable to detect stimulation of the nerve, [page 1] At this time, if the response to the stimulus is positive (+) in the 3D cranial nerve image, the cranial nerve is displayed in red, if it is negative (-), the cranial nerve is displayed in blue, and the cranial nerve displayed in red depends on the intensity of the response to the stimulus.
[page 1]…detects the reactive and non-reactive cranial nerves
and a nerve monitoring control system for receiving signals from the response sensor indicative of stimulation of the nerve by the tool and providing a signal to an operator or to the fluoroscopic image processing system; [page 1] At this time, if the response to the stimulus is positive (+) in the 3D cranial nerve image, the cranial nerve is displayed in red, if it is negative (-), the cranial nerve is displayed in blue, and the cranial nerve displayed in red depends on the intensity of the response to the stimulus.
an image processing system [page 1] image-based neuronavigation uses devices and display screen, [page 1] an electrophysiological stimulation device that displays a three-dimensional nerve image
including a fluoroscopic image of the tool within the brain; [page 4] the probe position detection unit 600 uses a camera as a means for detecting the position of the probe 110,
[page 3] To detect the position of the probe 110, various methods may be applied. The position of the probe 110 may be detected by RGB processing of an image captured by photographing a head.
[page 5] a plurality of cameras of the probe position detecting unit 600 may be provided, and the position of the probe 110 may be detected using images captured by a plurality of cameras
the image processing system being interoperable with the nerve monitoring system to correlate the fluoroscopic image of the tool with a signal from the response sensor indicative of stimulation of the nerve by the tool; [page 6] when the probe 110 of the nerve stimulation unit 100 is brought into contact with the corresponding head, when the stimulation emitted from the probe 110 is applied, the region to which the stimulation is applied is displayed as a three-dimensional brain nerve image on the display unit. Examiner interprets the region is displayed (image) as a result of when the probe is inserted and stimulation is emitted to be the correlation.
[page 4] the detection signal for the position of the probe 110 detected by the probe position detection unit 600 is transmitted to the microcomputer 300, and the three-dimensional coordinate system of the reactive and non-reactive cranial nerves is substituted by the microcomputer 300 When mapping to a dimensional cranial nerve image, a three-dimensional coordinate system for the position of the probe 110 detected in the head and brain shape images is applied and expressed on the mapped image.
[page 4] the neural monitoring unit 200 is electrically connected to a detector 210 coupled to one side of the probe 110, and receives and detects an electrical response signal corresponding to an electrical signal by the detector 210
wherein the image processing system is configured to generate a screen element corresponding to the location of the image of the tool on the display screen when input from the nerve monitoring system or input from an operator indicates that the tool has stimulated the nerve [page 3] the probe 110 further includes a marking means 113 for artificially displaying a line or point on a three-dimensional coordinate. Examiner interprets line or point to be a screen element.
[page 4] the probe position detection unit 600 uses a camera as a means for detecting the position of the probe 110, and the camera continuously and repeatedly photographs the measurement area (head), and the background (measurement area) among the captured images After analyzing the image in which the brightness, saturation, and color are contrasting, it is checked whether the analyzed image corresponds to the mark value of the probe 110, and if it is matched, a 3D coordinate system for the mark image contrasting with the background is calculated.
and display said screen element on the display screen at a location on the display screen corresponding to the location of the image of the tool. [page 3] the probe 110 further includes a marking means 113 for artificially displaying a line or point on a three-dimensional coordinate.
[page 6] when the probe 110 of the nerve stimulation unit 100 is brought into contact with the corresponding head, when the stimulation emitted from the probe 110 is applied, the region to which the stimulation is applied is displayed as a three-dimensional brain nerve image on the display unit.
[page 6] stores the cranial nerve image of the stimulus on the display unit 400 at the same time as it is displayed. Examiner understands stimulus to be a tool.
Hoon fails to explicitly teach generate fluoroscopic images and display fluoroscopic images on said display screen. Li, in the same field of analyzing anatomy in medical images during surgery (image-guided surgery) teaches wherein said image processing system is operable to generate fluoroscopic images and display fluoroscopic images on said display screen, Li [0007] the system comprises an ultrasound imaging system including an imaging probe operable to move internally and acquire ultrasound image data of the imaged subject, a fluoroscopic imaging system operable to acquire fluoroscopic image data of the imaged subject during image acquisition by the ultrasound imaging system. A display can be illustrative of the ultrasound image data acquired with the imaging probe in combination with a fluoroscopic imaging data acquired by the fluoroscopic imaging system.
Hoon is in the field of analyzing the brain in medical images acquired during surgery. Thus, before the effective filing date of the present application, it would have been obvious to one of ordinary skill in the art to combine the teachings of Hoon with the teachings of Li [0005] for precise guidance of the imaging catheter from the point of entry and through the vascular structure of the patient to a desired anatomical location is progressively becoming more important.
Claim 2. Hoon teaches wherein the image processing system is operable to identify the fluoroscopic image of the tool and generate and display the screen element at a position on the fluoroscopic image of the brain, [page 3] the probe 110 further includes a marking means 113 for artificially displaying a line or point on a three-dimensional coordinate. Examiner interprets line or point to be a screen element.
[page 4] the probe position detection unit 600 uses a camera as a means for detecting the position of the probe 110, and the camera continuously and repeatedly photographs the measurement area (head), and the background (measurement area) among the captured images After analyzing the image in which the brightness, saturation, and color are contrasting, it is checked whether the analyzed image corresponds to the mark value of the probe 110, and if it is matched, a 3D coordinate system for the mark image contrasting with the background is calculated.
said position corresponding to the position of the tool within the image of the brain upon receiving input that the nerve monitoring system, or an operator, provides input indicating the tool has stimulated the nerve. [page 4] the probe position detection unit 600 uses a camera as a means for detecting the position of the probe 110, and the camera continuously and repeatedly photographs the measurement area (head), and the background (measurement area) among the captured images After analyzing the image in which the brightness, saturation, and color are contrasting, it is checked whether the analyzed image corresponds to the mark value of the probe 110, and if it is matched, a 3D coordinate system for the mark image contrasting with the background is calculated.
[page 6] when the probe 110 of the nerve stimulation unit 100 is brought into contact with the corresponding head, when the stimulation emitted from the probe 110 is applied, the region to which the stimulation is applied is displayed as a three-dimensional brain nerve image on the display unit.
[page 6] stores the cranial nerve image of the stimulus on the display unit 400 at the same time as it is displayed. Examiner understands stimulus to be a tool.
Claim 3. Hoon teaches A method of visualizing a surgical site within the brain of a patient, [page 1] MRI the actual visible location corresponds to, while performing surgery
[page 1] displays a three-dimensional nerve image by mapping a functional cerebral nerve image by reconstructing the position in a three-dimensional space through a nerve navigation device.
including identifying and keeping track of nerves within the brain, said method comprising the steps of: [page 1] neuronavigation is used to accurately identify the location of structures during brain surgery
[page 9] the neural monitoring unit 200 includes a signal detection unit 220, the signal detection unit 220 receives the electrical response signal received from the detector 210
and operating an image processing system to display a fluoroscopic image of the brain while manipulating the tool; [page 1] At this time, if the response to the stimulus is positive (+) in the 3D cranial nerve image, the cranial nerve is displayed in red, if it is negative (-), the cranial nerve is displayed in blue, and the cranial nerve displayed in red depends on the intensity of the response to the stimulus.
[page 6] when the probe 110 of the nerve stimulation unit 100 is brought into contact with the corresponding head, when the stimulation emitted from the probe 110 is applied, the region to which the stimulation is applied is displayed as a three-dimensional brain nerve image on the display unit.
operating a nerve monitoring system to detect stimulation of a nerve caused by the tool; [page 1] when the probe 110 of the nerve stimulation unit 100 is brought into contact with the corresponding head, when the stimulation emitted from the probe 110 is applied, the region to which the stimulation is applied is displayed as a three-dimensional brain nerve image on the display unit.
[page 1] At this time, if the response to the stimulus is positive (+) in the 3D cranial nerve image, the cranial nerve is displayed in red, if it is negative (-), the cranial nerve is displayed in blue, and the cranial nerve displayed in red depends on the intensity of the response to the stimulus.
causing an image processing system to display a screen element in a position of the displayed fluoroscopic image corresponding to the position of the tool upon detecting stimulation of the nerve caused by the tool. [page 1] mapping to a dimensional cranial nerve image, a three-dimensional coordinate system for the position of the probe 110 detected in the head and brain shape images is applied and expressed on the mapped image.
[page 3] the probe 110 further includes a marking means 113 for artificially displaying a line or point on a three-dimensional coordinate.
[page 6] when the probe 110 of the nerve stimulation unit 100 is brought into contact with the corresponding head, when the stimulation emitted from the probe 110 is applied, the region to which the stimulation is applied is displayed as a three-dimensional brain nerve image on the display unit.
[page 6] stores the cranial nerve image of the stimulus on the display unit 400 at the same time as it is displayed. Examiner understands stimulus to be a tool.
Hoon fails to explicitly teach obtaining a fluoroscopic image of the brain while manipulating a tool within the brain. Li, in the same field of analyzing anatomy in medical images during surgery (image-guided surgery) teaches obtaining a fluoroscopic image of the brain while manipulating a tool within the brain Li [0007] the system comprises an ultrasound imaging system including an imaging probe operable to move internally and acquire ultrasound image data of the imaged subject, a fluoroscopic imaging system operable to acquire fluoroscopic image data of the imaged subject during image acquisition by the ultrasound imaging system
Hoon is in the field of analyzing the brain in medical images acquired during surgery. Thus, before the effective filing date of the present application, it would have been obvious to one of ordinary skill in the art to combine the teachings of Hoon with the teachings of Li [0005] for precise guidance of the imaging catheter from the point of entry and through the vascular structure of the patient to a desired anatomical location is progressively becoming more important.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0256051 A1 to Stone et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELOMIA L GILLIARD whose telephone number is (571)272-1681. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John Villecco can be reached at (571) 272-7319. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DELOMIA L GILLIARD/Primary Examiner, Art Unit 2661
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