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 .
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 line 2 – 3, limitation "to extract a first section intersecting the reference line" should read "to extract the first section intersecting the reference line"
Claim 2 line 5 – 6, "the second section extraction unit extracts the second section based on" should read "extract the second section based on"
Appropriate correction is required.
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 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites limitation “information” in line 5, it is unclear the above information is a newly introduced different information, or the same information as recited in claim 1 line 9.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable information.
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.
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 1 – 6, 8, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ciofolo-Veit et al. (US 2020/0015777 A1; published on 01/16/2020) (hereinafter "Ciofolo-Veit") in view of Welp et al. (Applicability of a semiautomated volumetric approach (5D CNS+™) for detailed antenatal reconstruction of abnormal fetal CNS anatomy; published on 09/02/2022) (hereinafter "Welp").
Regarding claim 1, Ciofolo-Veit teaches a medical processing apparatus ("The ultrasound imaging system 100 further comprises … a processor arrangement 210 including one or more processing elements, and controls the provision of an ultrasound image via the ultrasound system 100." [0036]) comprising:
a processing circuitry ("… a processor arrangement 210 including one or more processing elements …" [0036]) configured to:
acquire three-dimensional volume data of a subject ("… may receive ultrasound image data from the transducer array of the ultrasound probe 10 and provides a compounded three-dimensional (3D) ultrasound image derived from the different ultrasound data sets of the fetus 8." [0036]);
extract a first section intersecting a reference line of the subject included in the three-dimensional volume data ("In other words, any suitable starting point for the visualization of volume slices 51, 51′ along the fetal reference structure 80 may be chosen by the processor arrangement 210 from which a translation instruction as received from the user interface 120 along the fetal reference structure 80 may be initiated, e.g. to arrive at a further reference point 81′." [0045]; here the reference structure 81 is the reference line as shown in Fig.4, and the volume slice 51 is the first section).
Ciofolo-Veit fails to explicitly teach the processing circuitry is configured to: extract a second section intersecting the first section from the three-dimensional volume data based on a posture of the subject included in the first section; and output information based on the second section.
However, in the same field of endeavor, Welp teaches wherein the processing circuitry (“… to run the 5D CNS+™ tool …” Page 2, a computer is a must-have to run the commercially available software tool 5D CNS+) is configured to:
extract a first section intersecting a reference line of the subject included in the three-dimensional volume data ("Originating from an axial view of the fetal skull, which corresponds to the transventricular plane, all 3D volumes were acquired …" Page 2, see Fig.1; the axis of skull is the reference line for axial view);
extract a second section intersecting the first section from the three-dimensional volume data based on a posture of the subject included in the first section ("In the resulting triplanar view, the orthogonal planes were reoriented to align the falx cerebri horizontally (A and B plane). Then, to run the 5D CNS+™ tool, two reference points were placed manually (the 1st seed placed in the middle of the thalami and the 2nd seed placed in the cavum septi pellucidi) followed by the automatic reconstruction of the nine diagnostic planes of the CNS as described previously." Page 2; here the alignment of falx cerebri is the posture of the subject; see Fig.1, the MSP (midsagittal plane) is interpreted as the second section); and
output information based on the second section ("Evaluation of all planes in a single template or grouped for axial, coronal, and sagittal planes separately" Page 3 Table 1; "Panel e illustrates abnormal intracerebral findings attributed to a Chiari II malformation as a sequela from spina bifida aperta (descent of the tonsils and abnormal bowing of cerebellum in midsagittal and transcerebellar planes). There was also a marked dilatation of the lateral ventricles seen in all planes ..." Page 5, Fig.2).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the processing of axial view as taught by Ciofolo-Veit with the additional planes slicing as taught by Welp. Doing so would make it possible to provide "a standardized semiautomated approach of anatomic reconstruction of diagnostic CNS planes in the presence of congenital brain anomalies" (see Welp; Page 4 - 5).
Regarding claim 2, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 1, and Ciofolo-Veit further teaches wherein the processing circuitry is further configured to extract a first section intersecting the reference line and including a predetermined site of the subject ("In other words, any suitable starting point for the visualization of volume slices 51, 51′ along the fetal reference structure 80 may be chosen by the processor arrangement 210 from which a translation instruction as received from the user interface 120 along the fetal reference structure 80 may be initiated, e.g. to arrive at a further reference point 81′." [0045]; here the reference structure 81 is the reference line as shown in Fig.4, and the volume slice 51 is the first section).
In addition, Welp further teaches wherein the processing circuitry is further configured to extract a first section intersecting the reference line and including a predetermined site of the subject (see Fig.1a, the CSP is the predetermined site), and
the second section extraction unit extracts the second section based on the posture of the subject identified from the predetermined site ("In the resulting triplanar view, the orthogonal planes were reoriented to align the falx cerebri horizontally (A and B plane). Then, to run the 5D CNS+™ tool, two reference points were placed manually (the 1st seed placed in the middle of the thalami and the 2nd seed placed in the cavum septi pellucidi) followed by the automatic reconstruction of the nine diagnostic planes of the CNS as described previously." Page 2; here the alignment of falx cerebri is the posture of the subject; see Fig.1, the MSP (midsagittal plane) is interpreted as the second section).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the processing of axial view as taught by Ciofolo-Veit with the additional planes slicing as taught by Welp. Doing so would make it possible to provide "a standardized semiautomated approach of anatomic reconstruction of diagnostic CNS planes in the presence of congenital brain anomalies" (see Welp; Page 4 - 5).
Regarding claim 3, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 2, and Ciofolo-Veit further teaches wherein the processing circuitry is further configured to extract, as the first section, a section including the predetermined site of the subject among a plurality of sections intersecting a plurality of different positions of the reference line ("In other words, any suitable starting point for the visualization of volume slices 51, 51′ along the fetal reference structure 80 may be chosen by the processor arrangement 210 from which a translation instruction as received from the user interface 120 along the fetal reference structure 80 may be initiated, e.g. to arrive at a further reference point 81′." [0045]; here the reference structure 81 is the reference line as shown in Fig.4, and the volume slice 51 is the first section).
Regarding claim 4, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 1, and Ciofolo-Veit further teaches wherein:
the subject is a fetus ("… wherein an anatomical entity to be inspected is a fetus 8 …" [0035]), and
the processing circuitry is further configured to acquire the reference line based on a measurement target of the fetus included in the three-dimensional volume data ("… the processor arrangement 210 is adapted to identify a fetal reference structure 80 having an elongated shape in the imaging volume captured with the ultrasound probe 10." [0044]), and
extract the first section intersecting the reference line ("In other words, any suitable starting point for the visualization of volume slices 51, 51′ along the fetal reference structure 80 may be chosen by the processor arrangement 210 from which a translation instruction as received from the user interface 120 along the fetal reference structure 80 may be initiated, e.g. to arrive at a further reference point 81′." [0045]).
Regarding claim 5, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 4, and Ciofolo-Veit further teaches wherein:
the measurement target is a crown-rump length (CRL), and the processing circuitry is further configured to acquire the reference line based on the crown-rump length detected from the three-dimensional volume data ("In an embodiment, the fetal reference structure 80 is the spine of the fetus. Such a reference structure may be detected using any suitable detection algorithm, e.g. a segmentation algorithm as is well-known per se to the skilled person." [0044]).
Regarding claim 6, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 5, and Welp further teaches wherein the processing circuitry (“… to run the 5D CNS+™ tool …” Page 2, a computer is a must-have to run the commercially available software tool 5D CNS+) is further configured to:
extract, as the first section, a section intersecting the reference line and including a head of the fetus ("Originating from an axial view of the fetal skull, which corresponds to the transventricular plane …" Page 2, see Fig.1; "ROI should capture the entire contour of the fetal head (the box boundaries should be placed outside the skull)" Page 3 Table 1); and
extract the second section based on a posture of the fetus identified from the head of the fetus ("In the resulting triplanar view, the orthogonal planes were reoriented to align the falx cerebri horizontally (A and B plane). Then, to run the 5D CNS+™ tool, two reference points were placed manually (the 1st seed placed in the middle of the thalami and the 2nd seed placed in the cavum septi pellucidi) followed by the automatic reconstruction of the nine diagnostic planes of the CNS as described previously." Page 2; here the alignment of falx cerebri is the posture of the head; see Fig.1, the MSP (midsagittal plane) is interpreted as the second section).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the processing of axial view as taught by Ciofolo-Veit with the additional planes slicing as taught by Welp. Doing so would make it possible to provide "a standardized semiautomated approach of anatomic reconstruction of diagnostic CNS planes in the presence of congenital brain anomalies" (see Welp; Page 4 - 5).
Regarding claim 8, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 6, and Welp further teaches wherein the processing circuitry (“… to run the 5D CNS+™ tool …” Page 2, a computer is a must-have to run the commercially available software tool 5D CNS+) is further configured to detect an orientation of the head of the fetus as the posture of the fetus, and extract, as the second section, a median sagittal section of the fetus intersecting the first section and including the reference line based on the orientation of the head of the fetus ("In the resulting triplanar view, the orthogonal planes were reoriented to align the falx cerebri horizontally (A and B plane). Then, to run the 5D CNS+™ tool, two reference points were placed manually (the 1st seed placed in the middle of the thalami and the 2nd seed placed in the cavum septi pellucidi) followed by the automatic reconstruction of the nine diagnostic planes of the CNS as described previously." Page 2; here the alignment of falx cerebri is the posture of the head; see Fig.1, the MSP (midsagittal plane) is interpreted as the second section which include the axis of head).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the processing of axial view as taught by Ciofolo-Veit with the additional planes slicing as taught by Welp. Doing so would make it possible to provide "a standardized semiautomated approach of anatomic reconstruction of diagnostic CNS planes in the presence of congenital brain anomalies" (see Welp; Page 4 - 5).
Regarding claim 13, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 1, and Ciofolo-Veit further teaches wherein the processing circuitry is further configured to detect a plurality of anatomical structures of the subject and acquire, as the reference line, a line connecting feature points of the plurality of anatomical structures ("In an embodiment, the fetal reference structure 80 is the spine of the fetus. Such a reference structure may be detected using any suitable detection algorithm, e.g. a segmentation algorithm as is well-known per se to the skilled person." [0044]).
Regarding claim 16, Ciofolo-Veit teaches a medical processing method ("… there is provided a method of visualizing a volume slice of an imaging volume of a fetus with an ultrasound imaging system …" [0019]) comprising:
acquiring three-dimensional volume data of a subject ("… may receive ultrasound image data from the transducer array of the ultrasound probe 10 and provides a compounded three-dimensional (3D) ultrasound image derived from the different ultrasound data sets of the fetus 8." [0036]);
extracting a first section intersecting a reference line of a subject included in the three-dimensional volume data ("In other words, any suitable starting point for the visualization of volume slices 51, 51′ along the fetal reference structure 80 may be chosen by the processor arrangement 210 from which a translation instruction as received from the user interface 120 along the fetal reference structure 80 may be initiated, e.g. to arrive at a further reference point 81′." [0045]; here the reference structure 81 is the reference line as shown in Fig.4, and the volume slice 51 is the first section).
Ciofolo-Veit fails to explicitly teach extracting a second section intersecting the first section from the three-dimensional volume data based on a posture of the subject included in the first section; and outputting information based on the second section.
However, in the same field of endeavor, Welp teaches extracting a first section intersecting a reference line of a subject included in the three-dimensional volume data ("Originating from an axial view of the fetal skull, which corresponds to the transventricular plane, all 3D volumes were acquired …" Page 2, see Fig.1; the axis of skull is the reference line for axial view);
extracting a second section intersecting the first section from the three-dimensional volume data based on a posture of the subject included in the first section ("In the resulting triplanar view, the orthogonal planes were reoriented to align the falx cerebri horizontally (A and B plane). Then, to run the 5D CNS+™ tool, two reference points were placed manually (the 1st seed placed in the middle of the thalami and the 2nd seed placed in the cavum septi pellucidi) followed by the automatic reconstruction of the nine diagnostic planes of the CNS as described previously." Page 2; here the alignment of falx cerebri is the posture of the subject; see Fig.1, the MSP (midsagittal plane) is interpreted as the second section); and
outputting information based on the second section ("Evaluation of all planes in a single template or grouped for axial, coronal, and sagittal planes separately" Page 3 Table 1; "Panel e illustrates abnormal intracerebral findings attributed to a Chiari II malformation as a sequela from spina bifida aperta (descent of the tonsils and abnormal bowing of cerebellum in midsagittal and transcerebellar planes). There was also a marked dilatation of the lateral ventricles seen in all planes ..." Page 5, Fig.2).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the processing of axial view as taught by Ciofolo-Veit with the additional planes slicing as taught by Welp. Doing so would make it possible to provide "a standardized semiautomated approach of anatomic reconstruction of diagnostic CNS planes in the presence of congenital brain anomalies" (see Welp; Page 4 - 5).
Claim 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ciofolo-Veit in view of Welp, as applied in claim 6 and claim 1 respectively, and further in view of Lee et al. (US 2015/0250455 A1; published on 09/10/2015) (hereinafter "Lee").
Regarding claim 7, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 6, except wherein the processing circuitry is further configured to extract, as the first section including the head of the fetus, a section having a largest region representing the fetus, among a plurality of sections intersecting a plurality of different positions of the reference line.
However, in the same field of endeavor, Lee teaches wherein the processing circuitry is further configured to extract, as the first section including the head of the fetus, a section having a largest region representing the fetus, among a plurality of sections intersecting a plurality of different positions of the reference line ("… detecting a skull and a trident shape from the at least one candidate plane of the transthalamic plane, and the determining of the POI may include determining a candidate plane of the transthalamic plane, in which a size of the skull has a maximum value and the trident shape is detected, as the transthalamic plane." [0028]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the processing of axial view as taught by Ciofolo-Veit with the plane of interest determination as taught by Lee. Doing so would make it possible to provide a processing apparatus "that may automatically determine a plane-of-interest (POI), as desired by a user, in a three-dimensional (3D) brain image" (see Lee; [0007]).
Regarding claim 9, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 1, except wherein: the subject is a head, and the processing circuitry is further configured to acquire the reference line based on a measurement target of the head included in the three-dimensional volume data.
However, in the same field of endeavor, Lee teaches wherein: the subject is a head, and the processing circuitry is further configured to acquire the reference line based on a measurement target of the head included in the three-dimensional volume data ("… the POI may be at least one of a transthalamic plane which cuts the brain along a line b, a transventricular plane which cuts the brain along a line a, and a transcerebellar plane which cuts the brain alone a line c." [0104]; see Fig.8).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the processing of axial view as taught by Ciofolo-Veit with the plane of interest determination as taught by Lee. Doing so would make it possible to provide a processing apparatus "that may automatically determine a plane-of-interest (POI), as desired by a user, in a three-dimensional (3D) brain image" (see Lee; [0007]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ciofolo-Veit in view of Welp, as applied in claim 1, and further in view of Carneiro et al. (US 2009/0093717 A1; published on 04/09/2009) (hereinafter "Carneiro").
Regarding claim 15, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 1, except wherein the processing circuitry is further configured to detect a measurement target of the subject by inputting the three-dimensional volume data to a trained model, detecting a predetermined region of the subject by the trained model, and obtaining information regarding the measurement target of the subject from the predetermined region by a logic.
However, in the same field of endeavor, Carneiro teaches wherein the processing circuitry is further configured to detect a measurement target of the subject by inputting the three-dimensional volume data to a trained model, detecting a predetermined region of the subject by the trained model ("In act 22, a machine-trained classifier is applied to the three-dimensional ultrasound data." [0054]; "For example, a machine-trained head detector detects the location of a center of a fetal skull in a desired plane. Another machine-trained detector detects the location of the cerebellum, cisterna magna, lateral ventricles, combinations thereof, or other anatomy from the ultrasound data and as a function of the location of the center of the fetal skull." [0062]), and obtaining information regarding the measurement target of the subject from the predetermined region by a logic ("In act 34, a value of the fetal parameter associated with the fetal anatomy is measured." [0102]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the processing of axial view as taught by Ciofolo-Veit with the machine-learning classifier as taught by Carneiro. Doing so would make it possible to provide a system that "automatically indexes fetus structures despite the limitations of ultrasound imaging of the fetus for biometric measurements" (see Carneiro; [0017]).
Allowable Subject Matter
Claim 10 – 12 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 10, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 9, except wherein: the measurement target is a corpus callosum, and the processing circuitry is further configured to acquire the reference line based on the corpus callosum detected from the three-dimensional volume data.
Neither cited prior arts nor other search results collectively teach or suggest the feature of using the detected corpus callosum to acquire the reference line.
Claim 11 and 12 are dependent on claim 10, which inherently include the allowable features as discussed above.
Regarding claim 14, Ciofolo-Veit in view of Welp teaches all claim limitations, as applied in claim 1, except wherein the processing circuitry is further configured to change a position of the reference line based on a bilaterally symmetric anatomical structure included in the first section and extract the first section intersecting the changed reference line.
Neither cited prior arts nor other search results collectively teach or suggest the adjustment of reference line according to the detected anatomical asymmetry.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zou et al. (US 2017/0367685 A1; published on 12/28/2017) teach a method for processing 3D ultrasound data. Although callosum is one of the regions under study, Zou does not teach the determination of reference line for setting planes based on the detected callosum.
Lu et al. (US 2009/0074280 A1; published on 03/19/2009) teach automated detection of planes for 3D echocardiographic data. Machine trained classifiers are used to set planes intersecting the 3D volume.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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