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 Amendment
This action is in response to Applicant’s remarks, filed on 1/30/2026. The amendments to claim(s) 1, 5, 8 and 10-11 have been entered. Claim(s) 2 is/are cancelled by Applicant and therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b). Corresponding rejections of claim(s) 2 from the prior office action are withdrawn as moot in light of the Applicant’s cancellation. Accordingly, claim(s) 1 and 3-11 remain pending for examination.
Response to Arguments
Applicant’s arguments, see p. 8-14, with respect to the rejection of claim(s) 1 and 3-11 have been fully considered.
After review of the Applicant’s remarks regarding the interpretations under 35 U.S.C. § 112(f) of claim(s) 1 and 10, Examiner respectfully agrees with Applicant. The prior interpretation of claim 1 under 35 U.S.C. §112(f) is withdrawn, and the interpretation of claim 10 maintained. After review of the amendment to the claim(s), Examiner respectfully disagrees with the Applicant’s remarks and the 35 USC § 112(b) rejections are revised and ultimately maintained.
New grounds of rejection are made in view of the following: new amendments provided by Applicant and attached remarks; updated search and review of pertinent, eligible prior art; and/or different interpretation of the previously applied references.
Applicant’s arguments with respect to claim(s) 1 and 3-11 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.
Examiner respectfully notes that Applicant’s arguments only address independent claim(s) 1 and 10-11, and no remarks regarding the subject matter of the dependent claim(s) have been presented. Accordingly, the rejections to dependent claims 3-9 are modified to address Applicant’s amendments and the new rejection to independent claim(s) 1 and 10-11 and are sustained. The rejections of claim(s) 1 and 3-11 under 35 U.S.C. §102 and 35 U.S.C. §103 are maintained.
Claim Interpretation
35 U.S.C. 112(f)
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.
Such claim limitation(s) reciting the word “means” is/are:
Claim 10: “means for receiving reference frame data sent from an ultrasound diagnostic apparatus;
means for obtaining past volume data from the subject, […];
means for extracting the fitting frame data that fits the reference frame data from the past volume data by pattern matching, […]; and
means for transmitting the fitting frame data to the ultrasound diagnostic apparatus,”. The ‘means for receiving’, ‘means for obtaining’, ‘means for extracting’, and ‘means for transmitting’ are accordingly interpreted under 35 U.S.C. § 112(f).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1 and 3-11 is/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. Dependent claim(s) 3-9 are rejected at least by virtue of dependency upon a rejected claim.
Claims 1, 10 and 11 are indefinite. Claim 1 recites the limitation “an ultrasound diagnostic apparatus configured to form an ultrasound image based on reception data obtained from a subject and to obtain past volume data from the subject, wherein the past volume data is specified from a data group stored in a server and composed of a plurality of frame data which includes fitting frame data and comprises […], wherein the data group includes a plurality of volume data which includes the past volume data; an extraction apparatus comprising a processor configured to extract the fitting frame data that fits reference frame data sent from the ultrasound diagnostic apparatus from the past volume data by pattern matching wherein the processor is further configured to compare the reference frame data with a plurality of candidate frame data included in the plurality of frame data in the past volume data to extract specific candidate frame data with a best pattern matching as the fitting frame data” which renders the claim indefinite. The analogous language in independent claim 10 (i.e., “means for obtaining past volume data from the subject, […] to extract specific candidate frame data with a best pattern matching as the fitting frame data”) and independent claim 11 (i.e., “a function of obtaining past volume data from the subject, […] to extract specific candidate frame data with a best pattern matching as the fitting frame data”) is similarly indefinite.
These limitations are unclear. The language fails to define the relationship and organization of the various data elements (e.g., “past volume data”, “plurality of volume data”, “data group”, “fitting frame data”, “reference frame data”, “candidate frame data”, “frame data”, and so on). It is not clear if the ‘frame data’ and ‘fitting frame data’ are part of the ‘past volume data’, the ‘volume data’ or the ‘data group’. The claim also compares ‘reference frame data’ and ‘fitting frame data’ with ‘candidate frame data’; however this relationship is also unclear because the language does not clearly define what these data are. In particular, it is not clearly indicated what data is generated by the ultrasound diagnostic apparatus (e.g., data obtained during the procedure) vs. data stored in the server (e.g., preoperative data obtained prior to the procedure). It is suggested to amend the claim to clearly define the structural elements and the data that is acquired – or stored within – these structural elements, and to further define the contents and the type of data in a clear hierarchical structure (e.g., the server stores a ‘data group’, wherein the ‘data group’ is comprised of ‘volume data’, wherein the ‘volume data’ is comprised of ‘frame data’, etc.). Each hierarchical tier should define the type of data (e.g., the distinction between ‘reference frame data’, ‘candidate frame data’, ‘fitting frame data’) with respect to the relationship with ultrasound image acquisition or stored ultrasound images. For the purposes of examination, the broadest reasonable interpretation(s) of the claim language, including those discussed above, is applied to the limitations.
Claim 5 recites the limitations “comprising another processor configured to extract designated frame data from the past volume data based on designated frame identification information sent from the ultrasound diagnostic apparatus is provided, wherein the designated frame identification information specifies a frame number of a frame to be extracted from the volume data,” which renders the claim indefinite. The ‘designated frame data’ is not defined, and ‘designated frame identification information’ is unclear. In view of the ‘data’ discussion in the §112 rejections above, there is no clear definition of ‘designated frame data’, nor is there an adequate description of ‘designated frame identification information’ which would allow one of ordinary skill in the art what exactly is being claimed. It is unclear if the ‘frame to be extracted’ from the ‘volume data’ corresponds with the ‘designated frame data’ from the ‘past volume data’, since the ‘past volume data’ and ‘volume data’ are not necessarily the same element. It is suggested to amend the claim to particularly point out and distinctly claim the subject matter. For the purposes of examination, the broadest reasonable interpretation of the ‘designated frame data’ and ‘designated frame identification information’ are any information specifying ultrasound frame data.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 8-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Piron et al. (US20160067007A1, 2016-03-10; hereinafter “Piron”),
Regarding claim 1, Piron teaches an ultrasound diagnostic system (“A system for correlating a preoperative surgical plan with archival surgical plan data from one or more prior medical procedures” [clm 13]; “The system includes one or more imaging devices (for example, volumetric, whole organ, regional, point, or tool based), surgical guidance devices, software systems, databases, tissue specimen handling devices, and tracked medical instruments (e.g. surgical tools) as an integrated system.” [0151]; “a hand-held ultrasound probe may be used shortly after craniotomy during brain tumor resection to identify presence of vasculature immediately below the dura. The position relative to the brain where the ultrasound image (typically, a B-mode scan) is obtained and time instance when the image is recorded may be captured.” [0219]; [fig. 1-2, 5, 9]) comprising:
an ultrasound diagnostic apparatus configured to form an ultrasound image based on reception data obtained from a subject and to obtain past volume data from the subject (“obtaining preoperative surgical plan data associated with a medical procedure to be performed on a subject; […] accessing archival surgical plan data employed during the one or more prior medical procedures;” [clm 13]; “In the case in which a local tissue analysis is performed to obtain a local diagnostic image, the tissue analysis data may include the local image data. Non-limiting examples of local diagnostic images include, […] an ultrasound image” [0142]; “the system may be configured to correlate three-dimensional positions on or within subjects with pathology samples, preoperative or intraoperative images (volumetric, regional, point or tool based), and patient and economic outcomes, and an electronic data base of patient information.” [0151]; “For example a hand-held ultrasound probe may be used shortly after craniotomy during brain tumor resection to identify presence of vasculature immediately below the dura. The position relative to the brain where the ultrasound image (typically, a B-mode scan) is obtained and time instance when the image is recorded may be captured.” [0219]; “The system may comprise i) a navigation system that registers a set of volumetric imaging scans, to a patient frame of reference, ii) intraoperative imaging in a targeted region of interest, iii) software system to register preoperative imaging, intraoperative imaging,” [0239]; [0150-0164, 0186-0228], [fig. 1-2, 5, 9]),
wherein the past volume data is specified from a data group stored in a server and composed of a plurality of frame data which includes fitting frame data and comprises at least one of magnetic resonance imaging (MRI) volume data, computed tomography (CT) volume data, or ultrasound volume data, wherein the data group includes a plurality of volume data which includes the past volume data (“an example surgical plan may include preoperative 3D imaging data (e.g., MRI, ultrasound, etc.)” [0166]; “Registered data may be provided in the form of multiple images, data from different sensors, times, depths, or viewpoints. The process of registration is employed in the present application for medical imaging in which images from different imaging modalities are co-registered.” [0168]; “Control and processing unit 400 is interfaced with other external devices, such as tracking system 120, data storage 442, […] Data storage 442 may be any suitable data storage device, such as a local or remote computing device (e.g. a computer, hard drive, digital media device, or server) having a database stored thereon.” [0188]; “if the recording devices are not recording standard time, they may be synchronized using a common server that provides time information to multiple clients, […] and another client may be a computer-based image acquisition system used to acquire ultrasonic images.” [0220]; Preoperative 3D imaging data (i.e., past volume data) may be retrieved from a server and registered with intraoperative ultrasound imaging [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17]); and
an extraction apparatus comprising a processor configured to extract the fitting frame data that fits reference frame data sent from the ultrasound diagnostic apparatus from the past volume data by pattern matching (“a control and processing system comprising one or more processors and memory coupled to said one or more processors, […] comparing, according to pre-selected similarity criteria, the preoperative surgical plan data and the archival surgical plan data associated with the one or more prior medical procedures;” [clm 13]; “A set of preoperative images associated with the anatomy of interest of the subject may be obtained prior to surgery. These images may be intraoperatively registered to the subject, for example, by way of surface matching, […] These points or surfaces are registered to the tracking coordinate frame through a defined registration process. Once registered, medical instruments, and the associated subject images can be tracked in real-time,” [0158]; “Non-limiting examples of registration methods include intensity-based methods which compare intensity patterns in images via correlation metrics, while feature-based methods find correspondence between image features such as points, lines, and contours.” [0169]; “during a medical procedure, a handheld medical instrument may be tracked using a tracking system, and a representation of the instrument's position and orientation may be provided and displayed as an overlay on a previously acquired or current image (such as a three-dimensional scan) of a subject's anatomy obtained with an imaging device or system (such as ultrasound, CT or MRI).” [0172]; “The system may comprise i) a navigation system that registers a set of volumetric imaging scans, to a patient frame of reference, ii) intraoperative imaging in a targeted region of interest, iii) software system to register preoperative imaging, intraoperative imaging, and imaging of pathology samples,” [0239]; Registration between the coordinate frame of the tracking system and archival preoperative imaging with the coordinate frame of the corresponding intraoperative image is performed by matching image features and/or intensity patterns between the preop and intraop imaging [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17]),
wherein the processor is further configured to compare the reference frame data with a plurality of candidate frame data included in the plurality of frame data in the past volume data to extract specific candidate frame data with a best pattern matching as the fitting frame data (“identifying one or more similar prior medical procedures having archival surgical plan data satisfying the pre-selected similarity criteria; and” [clm 13]; “A set of preoperative images associated with the anatomy of interest of the subject may be obtained prior to surgery. These images may be intraoperatively registered to the subject, for example, by way of surface matching, […] These points or surfaces are registered to the tracking coordinate frame through a defined registration process. Once registered, medical instruments, and the associated subject images can be tracked in real-time,” [0158]; “Non-limiting examples of registration methods include intensity-based methods which compare intensity patterns in images via correlation metrics, while feature-based methods find correspondence between image features such as points, lines, and contours. Image registration algorithms may also be classified according to the transformation models they use to relate the target image space to the reference image space.” [0169]; “The system may comprise i) a navigation system that registers a set of volumetric imaging scans, to a patient frame of reference, ii) intraoperative imaging in a targeted region of interest, iii) software system to register preoperative imaging, intraoperative imaging, and imaging of pathology samples,” [0239]; “archived local tissue diagnostic data that is deemed to satisfy similarity criteria may be presented to an operator using a graphical user interface. In one example implementation, in which the similar archived local tissue diagnostic data is imaging data, the region in the imaging set with the confirmed pathology may be scaled and presented in a similar size, orientation, and/or configuration as the active case (the case which the physician is comparing against), in a compare mode.” [0286]; The archived diagnostic data (e.g., preoperative imaging) which satisfies similarity criteria and may be registered is compared with the local intraoperative imaging [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17]),
wherein the ultrasound diagnostic apparatus displays an image representing the fitting frame data together with the ultrasound image during an ultrasound examination of the subject (“a system that processes and spatially registers preoperative image data to an intraoperative reference frame, and displays the position and orientation of one or more tracked items relative to the preoperative image data. […] hardware associated with the navigation system may include a computer system, a display,” [0137]; “an example surgical plan may include preoperative 3D imaging data (e.g., MRI, ultrasound, etc.) overlaid with inputs (e.g., sulcal entry points, target locations, surgical outcome criteria, and additional 3D image data information) and displaying one or more trajectory paths based on the calculated score for a projected surgical path.” [0166]; “Each timestamp may be matched to a global timestamp associated with other events recorded during the medical procedure, such as a global timestamp associated with video captures (such as during a surgery, […] Further data can be integrated from any source from which a timestamp can be matched, including audio streams, video streams, state information of any imaging displays (e.g. data set, hanging protocol, window level, position, orientation, etc.)” [0205]; Registered intraoperative ultrasound images may be displayed along with other information relevant to the image and procedure [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17]).
Regarding claim 8, Piron teaches the ultrasound diagnostic system according to claim 1,
Piron further teaching wherein the processor is further configured to calculate a fitting score in response to performing comparing the reference frame data and the candidate frame data (“comparing, according to pre-selected similarity criteria, the preoperative surgical plan data and the archival surgical plan data associated with the one or more prior medical procedures;” [clm 13]; “Non-limiting examples of registration methods include intensity-based methods which compare intensity patterns in images via correlation metrics, while feature-based methods find correspondence between image features such as points, lines, and contours.” [0169]; “The system may comprise i) a navigation system that registers a set of volumetric imaging scans, to a patient frame of reference, ii) intraoperative imaging in a targeted region of interest, iii) software system to register preoperative imaging, intraoperative imaging, and imaging of pathology samples,” [0239]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]), and
the ultrasound diagnostic apparatus displays information indicating a fitting score corresponding to the fitting frame data together with the image representing the fitting frame data (“an example surgical plan may include preoperative 3D imaging data (e.g., MRI, ultrasound, etc.) overlaid with inputs (e.g., sulcal entry points, target locations, surgical outcome criteria, and additional 3D image data information) and displaying one or more trajectory paths based on the calculated score for a projected surgical path.” [0166]; “archived local tissue diagnostic data that is deemed to satisfy similarity criteria may be presented to an operator using a graphical user interface. In one example implementation, in which the similar archived local tissue diagnostic data is imaging data, the region in the imaging set with the confirmed pathology may be scaled and presented in a similar size, orientation, and/or configuration as the active case (the case which the physician is comparing against), in a compare mode.” [0286]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]).
Regarding claim 9, Piron teaches the ultrasound diagnostic system according to claim 1,
Piron further teaching wherein the reference frame data is one of past tomographic image data registered in the ultrasound diagnostic apparatus, current tomographic image data acquired in a current ultrasound examination on the subject, or pseudo tomographic image data cut out from a three-dimensional tissue model (“obtaining preoperative surgical plan data associated with a medical procedure to be performed on a subject;” [clm 13]; “Non-limiting examples of local diagnostic images include, for example, a white light image, a hyperspectral image, a polarization-sensitive image, an optical coherence tomography image, an ultrasound image, and a magnetic resonance imaging image.” [0142]; “an example surgical plan may include preoperative 3D imaging data (e.g., MRI, ultrasound, etc.) overlaid with inputs (e.g., sulcal entry points, target locations, surgical outcome criteria, and additional 3D image data information) and displaying one or more trajectory paths based on the calculated score for a projected surgical path.” [0166]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]).
Regarding claim 10, Piron teaches an extraction apparatus (“A system for correlating a preoperative surgical plan with archival surgical plan data from one or more prior medical procedures” [clm 13]; “The system includes one or more imaging devices (for example, volumetric, whole organ, regional, point, or tool based), surgical guidance devices, software systems, databases, tissue specimen handling devices, and tracked medical instruments (e.g. surgical tools) as an integrated system.” [0151]; “a hand-held ultrasound probe may be used shortly after craniotomy during brain tumor resection to identify presence of vasculature immediately below the dura. The position relative to the brain where the ultrasound image (typically, a B-mode scan) is obtained and time instance when the image is recorded may be captured.” [0219]; [fig. 1-2, 5, 9]) comprising:
means for receiving reference frame data sent from an ultrasound diagnostic apparatus (“obtaining preoperative surgical plan data associated with a medical procedure to be performed on a subject; […] accessing archival surgical plan data employed during the one or more prior medical procedures;” [clm 13]; “In the case in which a local tissue analysis is performed to obtain a local diagnostic image, the tissue analysis data may include the local image data. Non-limiting examples of local diagnostic images include, […] an ultrasound image” [0142]; “the system may be configured to correlate three-dimensional positions on or within subjects with pathology samples, preoperative or intraoperative images (volumetric, regional, point or tool based), and patient and economic outcomes, and an electronic data base of patient information.” [0151]; “For example a hand-held ultrasound probe may be used shortly after craniotomy during brain tumor resection to identify presence of vasculature immediately below the dura. The position relative to the brain where the ultrasound image (typically, a B-mode scan) is obtained and time instance when the image is recorded may be captured.” [0219]; “The system may comprise i) a navigation system that registers a set of volumetric imaging scans, to a patient frame of reference, ii) intraoperative imaging in a targeted region of interest, iii) software system to register preoperative imaging, intraoperative imaging,” [0239]; [0150-0164, 0186-0228], [fig. 1-2, 5, 9], [see claim 1 rejection]);
means for obtaining past volume data from the subject, wherein the past volume data is specified from a data group stored in a server and composed of a plurality of frame data which includes fitting frame data and comprises at least one of magnetic resonance imaging (MRI) volume data, computed tomography (CT) volume data, or ultrasound volume data, wherein the data group includes a plurality of volume data which includes the past volume data (“an example surgical plan may include preoperative 3D imaging data (e.g., MRI, ultrasound, etc.)” [0166]; “Registered data may be provided in the form of multiple images, data from different sensors, times, depths, or viewpoints. The process of registration is employed in the present application for medical imaging in which images from different imaging modalities are co-registered.” [0168]; “Control and processing unit 400 is interfaced with other external devices, such as tracking system 120, data storage 442, […] Data storage 442 may be any suitable data storage device, such as a local or remote computing device (e.g. a computer, hard drive, digital media device, or server) having a database stored thereon.” [0188]; “if the recording devices are not recording standard time, they may be synchronized using a common server that provides time information to multiple clients, […] and another client may be a computer-based image acquisition system used to acquire ultrasonic images.” [0220]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]);
means for extracting the fitting frame data that fits the reference frame data from the past volume data by pattern matching, wherein the reference frame data is compared with a plurality of candidate frame data included in the plurality of frame data in the past volume data to extract specific candidate frame data with a best pattern matching as the fitting frame data (“a control and processing system comprising one or more processors and memory coupled to said one or more processors, […] comparing, according to pre-selected similarity criteria, the preoperative surgical plan data and the archival surgical plan data associated with the one or more prior medical procedures;” [clm 13]; “A set of preoperative images associated with the anatomy of interest of the subject may be obtained prior to surgery. These images may be intraoperatively registered to the subject, for example, by way of surface matching, […] These points or surfaces are registered to the tracking coordinate frame through a defined registration process. Once registered, medical instruments, and the associated subject images can be tracked in real-time,” [0158]; “Non-limiting examples of registration methods include intensity-based methods which compare intensity patterns in images via correlation metrics, while feature-based methods find correspondence between image features such as points, lines, and contours.” [0169]; “during a medical procedure, a handheld medical instrument may be tracked using a tracking system, and a representation of the instrument's position and orientation may be provided and displayed as an overlay on a previously acquired or current image (such as a three-dimensional scan) of a subject's anatomy obtained with an imaging device or system (such as ultrasound, CT or MRI).” [0172]; “The system may comprise i) a navigation system that registers a set of volumetric imaging scans, to a patient frame of reference, ii) intraoperative imaging in a targeted region of interest, iii) software system to register preoperative imaging, intraoperative imaging, and imaging of pathology samples,” [0239]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]); and
means for transmitting the fitting frame data to the ultrasound diagnostic apparatus (“Control and processing unit 400 is interfaced with other external devices, such as tracking system 120, data storage 442, and external user input and output devices 444, […] Data storage 442 may be any suitable data storage device, such as a local or remote computing device (e.g. a computer, hard drive, digital media device, or server) having a database stored thereon.” [0188]; “an analysis engine is provided to evaluate similarity criteria between of one or more local tissue analyses performed on a subject, and prior local tissue analyses stored in data storage device 442, or otherwise accessible, such as through an external network.” [0193]; “The representation, transmission, receiving, recording, storing, and processing of information pertaining to a medical procedure as described herein may allow for efficient storage, communication, and processing of the state of tools and instruments involved in a procedure.” [0209]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]),
wherein an image representing the fitting frame data is displayed together with an ultrasound image during an ultrasound examination of the subject, in the ultrasound diagnostic apparatus (“a system that processes and spatially registers preoperative image data to an intraoperative reference frame, and displays the position and orientation of one or more tracked items relative to the preoperative image data. […] hardware associated with the navigation system may include a computer system, a display,” [0137]; “an example surgical plan may include preoperative 3D imaging data (e.g., MRI, ultrasound, etc.) overlaid with inputs (e.g., sulcal entry points, target locations, surgical outcome criteria, and additional 3D image data information) and displaying one or more trajectory paths based on the calculated score for a projected surgical path.” [0166]; “Each timestamp may be matched to a global timestamp associated with other events recorded during the medical procedure, such as a global timestamp associated with video captures (such as during a surgery, […] Further data can be integrated from any source from which a timestamp can be matched, including audio streams, video streams, state information of any imaging displays (e.g. data set, hanging protocol, window level, position, orientation, etc.)” [0205]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]).
Regarding claim 11, Piron teaches a non-transitory storage medium storing a program executed in an information processing apparatus (“A computer implemented method of correlating a preoperative surgical plan with archival surgical plan data from one or more prior medical procedures,” [clm 12]; “The system includes one or more imaging devices (for example, volumetric, whole organ, regional, point, or tool based), surgical guidance devices, software systems, databases, tissue specimen handling devices, and tracked medical instruments (e.g. surgical tools) as an integrated system.” [0151]; “a hand-held ultrasound probe may be used shortly after craniotomy during brain tumor resection to identify presence of vasculature immediately below the dura. The position relative to the brain where the ultrasound image (typically, a B-mode scan) is obtained and time instance when the image is recorded may be captured.” [0219]; [fig. 1-2, 5, 9]), the program including:
a function of receiving reference frame data sent from an ultrasound diagnostic apparatus (“obtaining preoperative surgical plan data associated with a medical procedure to be performed on a subject; […] accessing archival surgical plan data employed during the one or more prior medical procedures;” [clm 12]; “In the case in which a local tissue analysis is performed to obtain a local diagnostic image, the tissue analysis data may include the local image data. Non-limiting examples of local diagnostic images include, […] an ultrasound image” [0142]; “the system may be configured to correlate three-dimensional positions on or within subjects with pathology samples, preoperative or intraoperative images (volumetric, regional, point or tool based), and patient and economic outcomes, and an electronic data base of patient information.” [0151]; “For example a hand-held ultrasound probe may be used shortly after craniotomy during brain tumor resection to identify presence of vasculature immediately below the dura. The position relative to the brain where the ultrasound image (typically, a B-mode scan) is obtained and time instance when the image is recorded may be captured.” [0219]; “The system may comprise i) a navigation system that registers a set of volumetric imaging scans, to a patient frame of reference, ii) intraoperative imaging in a targeted region of interest, iii) software system to register preoperative imaging, intraoperative imaging,” [0239]; [0150-0164, 0186-0228], [fig. 1-2, 5, 9], [see claim 1 rejection]);
a function of obtaining past volume data from the subject, wherein the past volume data is specified from a data group stored in a server and composed of a plurality of frame data which includes fitting frame data and comprises at least one of magnetic resonance imaging (MRI) volume data, computed tomography (CT) volume data, or ultrasound volume data, wherein the data group includes a plurality of volume data which includes the past volume data (“an example surgical plan may include preoperative 3D imaging data (e.g., MRI, ultrasound, etc.)” [0166]; “Registered data may be provided in the form of multiple images, data from different sensors, times, depths, or viewpoints. The process of registration is employed in the present application for medical imaging in which images from different imaging modalities are co-registered.” [0168]; “Control and processing unit 400 is interfaced with other external devices, such as tracking system 120, data storage 442, […] Data storage 442 may be any suitable data storage device, such as a local or remote computing device (e.g. a computer, hard drive, digital media device, or server) having a database stored thereon.” [0188]; “if the recording devices are not recording standard time, they may be synchronized using a common server that provides time information to multiple clients, […] and another client may be a computer-based image acquisition system used to acquire ultrasonic images.” [0220]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]);
a function of extracting, the fitting frame data that fits the reference frame data from the past volume data by pattern matching, wherein the reference frame data is compared with a plurality of candidate frame data included in the plurality of frame data in the past volume data to extract specific candidate frame data with a best pattern matching as the fitting frame data (“comparing, according to pre-selected similarity criteria, the preoperative surgical plan data and the archival surgical plan data associated with the one or more prior medical procedures;” [clm 12]; “A set of preoperative images associated with the anatomy of interest of the subject may be obtained prior to surgery. These images may be intraoperatively registered to the subject, for example, by way of surface matching, […] These points or surfaces are registered to the tracking coordinate frame through a defined registration process. Once registered, medical instruments, and the associated subject images can be tracked in real-time,” [0158]; “Non-limiting examples of registration methods include intensity-based methods which compare intensity patterns in images via correlation metrics, while feature-based methods find correspondence between image features such as points, lines, and contours.” [0169]; “during a medical procedure, a handheld medical instrument may be tracked using a tracking system, and a representation of the instrument's position and orientation may be provided and displayed as an overlay on a previously acquired or current image (such as a three-dimensional scan) of a subject's anatomy obtained with an imaging device or system (such as ultrasound, CT or MRI).” [0172]; “The system may comprise i) a navigation system that registers a set of volumetric imaging scans, to a patient frame of reference, ii) intraoperative imaging in a targeted region of interest, iii) software system to register preoperative imaging, intraoperative imaging, and imaging of pathology samples,” [0239]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]); and
a function of transmitting the fitting frame data to the ultrasound diagnostic apparatus (“Control and processing unit 400 is interfaced with other external devices, such as tracking system 120, data storage 442, and external user input and output devices 444, […] Data storage 442 may be any suitable data storage device, such as a local or remote computing device (e.g. a computer, hard drive, digital media device, or server) having a database stored thereon.” [0188]; “an analysis engine is provided to evaluate similarity criteria between of one or more local tissue analyses performed on a subject, and prior local tissue analyses stored in data storage device 442, or otherwise accessible, such as through an external network.” [0193]; “The representation, transmission, receiving, recording, storing, and processing of information pertaining to a medical procedure as described herein may allow for efficient storage, communication, and processing of the state of tools and instruments involved in a procedure.” [0209]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]),
wherein an image representing the fitting frame data is displayed together with an ultrasound image during an ultrasound examination of the subject, in the ultrasound diagnostic apparatus (“a system that processes and spatially registers preoperative image data to an intraoperative reference frame, and displays the position and orientation of one or more tracked items relative to the preoperative image data. […] hardware associated with the navigation system may include a computer system, a display,” [0137]; “an example surgical plan may include preoperative 3D imaging data (e.g., MRI, ultrasound, etc.) overlaid with inputs (e.g., sulcal entry points, target locations, surgical outcome criteria, and additional 3D image data information) and displaying one or more trajectory paths based on the calculated score for a projected surgical path.” [0166]; “Each timestamp may be matched to a global timestamp associated with other events recorded during the medical procedure, such as a global timestamp associated with video captures (such as during a surgery, […] Further data can be integrated from any source from which a timestamp can be matched, including audio streams, video streams, state information of any imaging displays (e.g. data set, hanging protocol, window level, position, orientation, etc.)” [0205]; [0150-0228, 0291-0305], [fig. 1-2, 4A-5, 9, 14A, 17], [see claim 1 rejection]).
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.
Claim(s) 3-7 is/are rejected under pre-AIA 35 U.S.C. 103 as being obvious over Piron as applied to claim 1 above, in view of Martin et al. (US20120116218A1, 2012-05-10; hereinafter “Martin”).
Regarding claim 3, Piron teaches the ultrasound diagnostic system according to claim 1,
but Piron may fail to explicitly teach the thumbnail image.
However, in the same field of endeavor, Martin teaches an ultrasound diagnostic system (“An ultrasound system” [clm 18]; “The display 218 includes one or more monitors that present patient information, including diagnostic ultrasound images to the user for diagnosis and analysis.” [0047]; [fig. 4-9]);
Martin further teaching wherein the ultrasound diagnostic apparatus includes a thumbnail image generation unit that generates a thumbnail image as the image representing the fitting frame data, based on the fitting frame data (“Further, other information may be displayed, such as thumbnail images 110, which may correspond to individually acquired frames or cine loops that are saved in the ultrasound system.” [0039]; Thumbnail images are generated for display [0042-0066], [fig. 3-9]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound diagnostic system as taught by Piron with the thumbnail image taught by Martin. Imaging and imaging guidance is becoming a more significant component of surgical care, from diagnosis of disease, monitoring of the disease, planning of the surgical approach, guidance during the procedure and follow-up after the procedure is complete, or as part of a multi-faceted treatment approach (Piron [0010]). The combined system may provide different display and operation options for a user. Accordingly, a user may be able to assess a physical or physiological state of the patient using external inputs, such that the only difference in the acquired data, for example, between different exams, is based on a course of treatment (Martin [0040]).
Regarding claim 4, Piron and Martin teach the ultrasound diagnostic system according to claim 3,
Martin further teaching wherein the ultrasound diagnostic apparatus displays a screen image including the ultrasound image (“illustrating an exemplary display 80 (e.g., a user interface) a color flow ultrasound image 82 may be displayed having a color-coded map of Doppler shifts (illustrated by colored regions 84, such as different shades of red, blue, etc.) superimposed onto a B-mode ultrasound image.” [0028]; [fig. 3-9], [see claim 1 rejection]),
the thumbnail image is a first thumbnail image, the thumbnail image generation unit further generates a second thumbnail image representing the reception data obtained by the ultrasound diagnostic apparatus, and the screen image includes an external data display area in which the first thumbnail image is displayed, and an internal data display area in which the second thumbnail image is displayed (“The display 80 as shown in FIG. 3 may also include additional user selectable members (e.g., icons) allowing a user to initiate or perform additional or alternative operations. […] Additionally, different display formats, such as a short or long display form of data may be selected using the data form selection members 106.” [0038]; “Further, other information may be displayed, such as thumbnail images 110, which may correspond to individually acquired frames or cine loops that are saved in the ultrasound system.” [0039]; Multiple thumbnail images are presented to the user for display, wherein the ultrasound image, thumbnail images, quantitative data, etc. may be presented in subdivided portions of the display [0042-0066], [fig. 4-9; see fig. 3 reproduced below]).
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First and second thumbnail images are presented among a plurality of thumbnail images in a portion of the display as an array with interior and exterior thumbnail(s) (Martin [fig. 3])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound diagnostic system as taught by Piron with the thumbnail image taught by Martin. Imaging and imaging guidance is becoming a more significant component of surgical care, from diagnosis of disease, monitoring of the disease, planning of the surgical approach, guidance during the procedure and follow-up after the procedure is complete, or as part of a multi-faceted treatment approach (Piron [0010]). The combined system may provide different display and operation options for a user. Accordingly, a user may be able to assess a physical or physiological state of the patient using external inputs, such that the only difference in the acquired data, for example, between different exams, is based on a course of treatment (Martin [0040]).
Regarding claim 5, Piron and Martin teach the ultrasound diagnostic system according to claim 3,
Martin further teaching wherein the extraction apparatus is a secondary extraction apparatus (“The ultrasound processor module 236 is illustrated conceptually as a collection of sub-modules, but may be implemented utilizing any combination of dedicated hardware boards, DSPs, processors, etc.” [0049]; [fig. 4-6]),
the thumbnail image is a secondary thumbnail image (“Further, other information may be displayed, such as thumbnail images 110, which may correspond to individually acquired frames or cine loops that are saved in the ultrasound system.” [0039]; [fig. 3], [see claim 4 rejection]),
a primary extraction apparatus, comprising another processor configured to extract designated frame data from the past volume data based on designated frame identification information sent from the ultrasound diagnostic apparatus is provided, wherein the designated frame identification information specifies a frame number of a frame to be extracted from the volume data (“The line 94 may automatically move during display of the cine loop over time or may be manually moved and stopped by a user at a particular frame. It should be noted that frame data 98 may be displayed indicating the total number of acquired frames of data. For example, in the illustrated embodiment, 24:56 means that the current displayed image is from frame 24 of a total of 56 frames.” [0032]; “The ultrasound system 200 also includes a processor 216 to process the acquired ultrasound information (e.g., RF signal data or IQ data pairs) and prepare frames of ultrasound information for display on the display 218.” [0046]; “the sub-modules of FIG. 10 may be implemented utilizing an off-the-shelf PC with a single processor or multiple processors, with the functional operations distributed between the processors.” [0049]; The ultrasound system may comprise multiple processors for processing data for display [0042-0066], [fig. 4-6]),
the thumbnail image generation unit further generates a primary thumbnail image as an image representing the designated frame data, and the ultrasound diagnostic apparatus displays the primary thumbnail image and the secondary thumbnail image (“Further, other information may be displayed, such as thumbnail images 110, which may correspond to individually acquired frames or cine loops that are saved in the ultrasound system.” [0039]; Multiple thumbnail images may be presented in the display [0042-0066], [fig. 3-8], [see claim 4 rejection]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound diagnostic system as taught by Piron with the thumbnail image taught by Martin. Imaging and imaging guidance is becoming a more significant component of surgical care, from diagnosis of disease, monitoring of the disease, planning of the surgical approach, guidance during the procedure and follow-up after the procedure is complete, or as part of a multi-faceted treatment approach (Piron [0010]). The combined system may provide different display and operation options for a user. Accordingly, a user may be able to assess a physical or physiological state of the patient using external inputs, such that the only difference in the acquired data, for example, between different exams, is based on a course of treatment (Martin [0040]).
Regarding claim 6, Piron and Martin teach the ultrasound diagnostic system according to claim 5,
Martin further teaching wherein the ultrasound diagnostic apparatus displays the primary thumbnail image first, and then displays the secondary thumbnail image instead of the primary thumbnail image (“Thus, acquired data including correlated quantitative data and physiological data from an ultrasound loop, for example, a plurality of heartbeats of a patient, may be displayed in time aligned manner, such as on a single graph 96.” [0035]; “Further, other information may be displayed, such as thumbnail images 110, which may correspond to individually acquired frames or cine loops that are saved in the ultrasound system.” [0039]; “including the display of information, may be provided after acquisition based on data stored in memory or while image acquisition is occurring, […] Accordingly, the cine loop may be displayed based on different phases of the physiological data or the ROI, color scale, grayscale levels or other variables or parameters that may be changed after acquisition of the ultrasound data.” [0041]; A cine loop of multiple ultrasound images and corresponding thumbnail images may be sequentially presented for display [0042-0066], [fig. 3-8]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound diagnostic system as taught by Piron with the thumbnail image taught by Martin. Imaging and imaging guidance is becoming a more significant component of surgical care, from diagnosis of disease, monitoring of the disease, planning of the surgical approach, guidance during the procedure and follow-up after the procedure is complete, or as part of a multi-faceted treatment approach (Piron [0010]). The combined system may provide different display and operation options for a user. Accordingly, a user may be able to assess a physical or physiological state of the patient using external inputs, such that the only difference in the acquired data, for example, between different exams, is based on a course of treatment (Martin [0040]).
Regarding claim 7, Piron and Martin teach the ultrasound diagnostic system according to claim 5,
Martin further teaching wherein the ultrasound diagnostic apparatus displays identification information for identifying the primary thumbnail image and the secondary thumbnail image (“the correlation of the monitoring data and quantification data includes, for example, time associating the data such that the physiological value (e.g., at 1.2 seconds after acquisition start) is associated with the quantitative ultrasound value at the frame acquired at that time.” [0023]; “the frame of ultrasound data corresponding to the displayed ultrasound image 82 and the numerical quantitative data 92 is identified by a line 94 on the graph 96 in the quantitative display portion 90. The line 94 may automatically move during display of the cine loop over time or may be manually moved and stopped by a user at a particular frame. It should be noted that frame data 98 may be displayed indicating the total number of acquired frames of data” [0032]; “other information may be displayed, such as thumbnail images 110, which may correspond to individually acquired frames or cine loops that are saved in the ultrasound system.” [0039]; Image frame information is presented to the user on the display [0042-0066], [fig. 3, 6], [see claim 5 rejection]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound diagnostic system as taught by Piron with the thumbnail image taught by Martin. Imaging and imaging guidance is becoming a more significant component of surgical care, from diagnosis of disease, monitoring of the disease, planning of the surgical approach, guidance during the procedure and follow-up after the procedure is complete, or as part of a multi-faceted treatment approach (Piron [0010]). The combined system may provide different display and operation options for a user. Accordingly, a user may be able to assess a physical or physiological state of the patient using external inputs, such that the only difference in the acquired data, for example, between different exams, is based on a course of treatment (Martin [0040]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at 5712727230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
Prosecution Insights