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 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 2, 3 and 5 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.
Claim 2 recites limitation “based on a change in a shape of the contour over a plurality of heartbeats”, and claim 3 recites limitation “an amount of change in the shape of the contour over the plurality of heartbeats”. It appears there should be multiple contours from multiple images to result in a change of shape. However, claim 1 recites “an ultrasound image” and “a contour of the intracardiac cavity”, there is no multiple images for the change. It is unclear how a change of shape can be determined from one image.
Thus, the above limitations render claims indefinite. For the purpose of examination, the above limitations are interpreted as any reasonable contour shape change.
Claim 5 recites limitation “an amount of change in the confidence level in the region of the intracardiac cavity”. It appears there should be multiple regions of multiple confident levels to result in a change. However, claim 4 recites “a confidence level of a region of the extracted intracardiac cavity”, there is no multiple regions to calculate multiple different confident levels. It is unclear how a change of confident level can be determined if there is only one region considered.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable confident level.
Therefore, claim 2, 3 and 5 are ejected under 35 U.S.C. 112(b) as being indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 – 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to mental processes without significantly more.
The claims recite limitations which are mental process as following:
Claim 1 recites “extract an intracardiac cavity from an ultrasound image in which a heart of a subject is imaged; analyze a contour of the intracardiac cavity and estimate a possibility of correction in each portion of the contour for evaluating functionality of the heart; specify a control point on the contour based on the possibility of correction; receive a correction operation performed by a user on the control point; and correct the contour based on the correction operation.”
Claim 2 recites “estimate the possibility of correction in each portion of the contour based on a change in a shape of the contour over a plurality of heartbeats.”
Claim 3 recites “specify the control point in a portion in which an amount of change in the shape of the contour over the plurality of heartbeats is equal to or greater than a first threshold value.”
Claim 4 recites “calculate a confidence level of a region of the extracted intracardiac cavity; and estimate the possibility of correction in each portion of the contour based on the confidence level.”
Claim 5 recites “specify the control point in a portion in which an amount of change in the confidence level in the region of the intracardiac cavity is equal to or less than a second threshold value.”
Claim 6 recites “estimate the possibility of correction in each portion of the contour based on a change in a brightness value on the contour.”
Claim 7 recites “specify the control point in a portion in which an amount of change in the brightness value on the contour is equal to or greater than a third threshold value.”
Claim 8 recites “extracting an intracardiac cavity from an ultrasound image in which a heart of a subject is imaged; analyzing a contour of the extracted intracardiac cavity and estimating a possibility of correction in each portion of the contour for evaluating functionality of the heart; specifying a control point on the contour based on the estimated possibility of correction; receiving a correction operation performed by a user on the control point; and correcting the contour based on the correction operation.
All above limitations can be performed in the human mind, or by a human using a pen and paper. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011).
This judicial exception is not integrated into a practical application because all claims merely recite the process of generate a contour but fails to positively recite the actual usage of the contour. Although claim 1 and 8 recite “the contour for evaluating functionality of the heart”, there is no specific limitation to describe how the contour is used for evaluating.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
Although claim 1 – 7 recites a processor, the above identified mental process could be performed by humans without a computer. As the Federal Circuit has explained, “[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016). There is no other additional limitation recited in claim 1 – 7.
Claim 8 is directed to a control method without reciting any additional limitations.
Therefore, claim 1 – 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to mental processes without significantly more.
Claim Rejections - 35 USC § 102
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 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.
Claim 1 – 5 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chenal et al. (US 2002/0072671 A1; published on 06/13/2002) (hereinafter "Chenal").
Regarding claim 1, Chenal discloses an ultrasound diagnostic apparatus ("Referring first to FIG. 1, an ultrasound system …" [0023]) comprising:
a processor configured to ("... the ABD processor is actuated to …" [0026]):
extract an intracardiac cavity ("... to automatically delineate the LV borders on the two displayed images as well as the intervening undisplayed images between end diastole and end systole." [0026]) from an ultrasound image in which a heart of a subject is imaged ("The ultrasound image 10 is a four-chamber view of the heart which is acquired by a phased array transducer probe to produce the illustrated sector-shaped image." [0023]; "Thus, the clinician can select an earlier or later end diastole or end systole image from those selected by the ultrasound system." [0026]);
analyze a contour of the intracardiac cavity and estimate a possibility of correction in each portion of the contour ("The clinician can review the end diastole and systole images, as well as all of the intervening images of the loop if desired, and ... if it is seen that the automated process placed a border in an incorrect position." [0035]) for evaluating functionality of the heart ("With the ability to automatically draw borders of structures of the heart such as the endocardium on a complete loop of images, a number of diagnostic techniques become practical. For instance, FIG. 11 illustrates a technique for assessing regional wall motion using automated border detection." [0045]);
specify a control point on the contour based on the possibility of correction ("… and manually adjust the positions of the landmark boxes and control point X's if it is seen that the automated process placed a border in an incorrect position … Suppose that the ABD processor had initially located the control point and border at the position shown by circle 82 and dashed line 84, which the clinician observes is incorrect." [0035]);
receive a correction operation performed by a user on the control point ("The clinician can relocate the control point laterally by dragging the X with a screen pointing device to the new location as shown by 86." [0035]); and
correct the contour based on the correction operation ("As the X is dragged, the border moves or stretches along with the X, thereby defining a new border as shown by the solid line border 88. In this manner the clinician can manually correct and adjust the borders drawn by the ABD processor." [0035]).
Regarding claim 2, Chenal discloses all claim limitations, as applied in claim 1, and further discloses wherein the processor is configured to estimate the possibility of correction in each portion of the contour based on a change in a shape of the contour over a plurality of heartbeats ("… to assemble only the border tracings in a “stack” in time sequence from ED to ES … If the clinician sees a point on the surface formed by the borders which is out of alignment with temporally adjacent tracings or the desired border, the clinician can pull or push on the surface with a pointing device." [0036]).
Regarding claim 3, Chenal discloses all claim limitations, as applied in claim 2, and further discloses wherein the processor is configured to specify the control point in a portion in which an amount of change in the shape of the contour over the plurality of heartbeats is equal to or greater than a first threshold value ("If the clinician sees a point on the surface formed by the borders which is out of alignment with temporally adjacent tracings or the desired border, the clinician can pull or push on the surface with a pointing device." [0036]; here "out of alignment" is equivalent to the displacement being equal to or greater than a threshold).
Regarding claim 4, Chenal discloses all claim limitations, as applied in claim 1, and further discloses wherein the processor is configured to:
calculate a confidence level of a region of the extracted intracardiac cavity ("Since the LV is expanding when proceeding from systole to diastole, confidence measures include the displacement of the landmark points in an outward direction from frame to frame. When the three landmark points are found in a frame, the appropriately scaled standard shape is fit to the three points. Another confidence measure is distention of the standard shapes ..." [0033]); and
estimate the possibility of correction in each portion of the contour based on the confidence level ("As the ABD processor is identifying the key landmarks and fitting borders to the sequence of images, it is periodically making confidence measurements to gauge the likelihood that the image borders are being accurately located and traced." [0039]).
Regarding claim 5, Chenal discloses all claim limitations, as applied in claim 4, and further discloses wherein the processor is configured to specify the control point in a portion in which an amount of change in the confidence level in the region of the intracardiac cavity is equal to or less than a second threshold value ("Both spatial and temporal confidence measurements are employed. For instance, if the computed border of an image varies too much from a standard shape in either size or shape, the process will abort. This can arise if the landmarks are located in unusual positions in relation to each other, for example. If the change in the computed border from one image in the sequence to another is too great, the process will likewise abort. When the process stops, a message is displayed notifying the clinician of the reason for stopping the process, and gives the clinician the option ... to continue the automated process with or after clinician input ..." [0039]; here the great change means low confidence under threshold; "The clinician can relocate the control point laterally by dragging the X with a screen pointing device to the new location as shown by 86." [0035]; and the dragging of control point is the clinician input).
Regarding claim 8, Chenal discloses a method of controlling an ultrasound diagnostic apparatus ("… the clinician observes the beating heart in real time while manipulating the transducer probe so that the LV is being viewed distinctly in maximal cross-section ... the “ABD” protocol is actuated to start the border drawing process." [0024]), the control method comprising:
extracting an intracardiac cavity ("... to automatically delineate the LV borders on the two displayed images as well as the intervening undisplayed images between end diastole and end systole." [0026]) from an ultrasound image in which a heart of a subject is imaged ("The ultrasound image 10 is a four-chamber view of the heart which is acquired by a phased array transducer probe to produce the illustrated sector-shaped image." [0023]; "Thus, the clinician can select an earlier or later end diastole or end systole image from those selected by the ultrasound system." [0026]);
analyzing a contour of the extracted intracardiac cavity and estimating a possibility of correction in each portion of the contour ("The clinician can review the end diastole and systole images, as well as all of the intervening images of the loop if desired, and ... if it is seen that the automated process placed a border in an incorrect position." [0035]) for evaluating functionality of the heart ("With the ability to automatically draw borders of structures of the heart such as the endocardium on a complete loop of images, a number of diagnostic techniques become practical. For instance, FIG. 11 illustrates a technique for assessing regional wall motion using automated border detection." [0045]);
specifying a control point on the contour based on the estimated possibility of correction ("… and manually adjust the positions of the landmark boxes and control point X's if it is seen that the automated process placed a border in an incorrect position … Suppose that the ABD processor had initially located the control point and border at the position shown by circle 82 and dashed line 84, which the clinician observes is incorrect." [0035]);
receiving a correction operation performed by a user on the control point ("The clinician can relocate the control point laterally by dragging the X with a screen pointing device to the new location as shown by 86." [0035]); and
correcting the contour based on the correction operation ("As the X is dragged, the border moves or stretches along with the X, thereby defining a new border as shown by the solid line border 88. In this manner the clinician can manually correct and adjust the borders drawn by the ABD processor." [0035]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Chenal, as applied in claim 1, and further in view of Cheline et al. (US 2014/0100440 A1; published on 04/10/2014) (hereinafter "Cheline").
Regarding claim 6, Chenal teaches all claim limitations, as applied in claim 1, except wherein the processor is configured to estimate the possibility of correction in each portion of the contour based on a change in a brightness value on the contour.
However, in the same field of endeavor, Cheline teaches wherein the processor is configured to estimate the possibility of correction in each portion of the contour based on a change in a brightness value on the contour ("In doing so, the active-contour application may consider or take into account at least (i) image gradients (i.e., gradient data) ... Specifically, by considering gradient data (or a gradient factor), the border can be adjusted if the neighboring pixels (as opposed to the pixels of the border) include border characteristics (e.g., a dark-to-light transition, etc.)." [0100]).
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 border detection process as taught by Chenal with the border detection process as taught by Cheline. By using image gradient data, it is possible to "adjust the border to more closely match the actual border" (see Cheline; [0100]).
Regarding claim 7, Chenal in view of Cheline teaches all claim limitations, as applied in claim 6, and Cheline further teaches wherein the processor is configured to specify the control point in a portion in which an amount of change in the brightness value on the contour ("These additional control points are then used to approximate at least one other border at step 818, which is then adjusted at step 820. In one embodiment, the border is adjusted in accordance with at least gradient data." [0103]) is equal to or greater than a third threshold value ("… it may be necessary to utilize an algorithm and/or at least one threshold value to identify precisely where the image changes from light to dark (or vice versa)." [0095]; in image processing, large gradient means sharp dark-to-light transition).
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 border detection process as taught by Chenal with the border detection process as taught by Cheline. By using image gradient data, it is possible to "adjust the border to more closely match the actual border" (see Cheline; [0100]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Salgo et al. (US 2011/0098562 A1; published on 04/28/2011) teach a cardiac chamber segmentation based on control points.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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