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 § 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 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuitjen, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter).
A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C.§101 by adding the limitation “non-transitory” to the claim.
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 10 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.
In claim 10, the limitation “checking if the output B-mode gain value the global image entropy of the B-mode ultrasound image resulting from the output B-mode gain value is within the target entropy range” renders the claim indefinite. The language “output B-mode gain value the global image entropy” appears to be grammatically incorrect. Also, it is unclear what is meant by the language “resulting from” in this context.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6-8, and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freiburger et al. (US 2019/0261952; hereinafter Freiburger) in view of Kim et al. (US 2012/0123265; hereinafter Kim).
Freiburger shows a system and computer implemented method for identifying a gain parameter value for ultrasound hemodynamic analysis, comprising: obtaining a B-mode ultrasound image of a blood vessel ([0022]-[0025]); determining a global B-mode gain value ([0043], [0056]); identifying a region of interest of the B-mode ultrasound image resulting from the global B-mode gain value (location in field of view; [0044], [0057]-[0058]); and determining an output B-mode gain value based on a contrast-to-noise ratio of the region of interest (signal to noise ratio used to optimize gain; [0043], [0055]). Freiburger also shows wherein adjusting the initial B-mode gain value to determine the global B-mode gain value comprises one of: increasing the global B-mode gain value from the initial B-mode gain value; or decreasing the global B-mode gain value from the initial B-mode gain value (gain increased or decreased for optimization; [0055]-[0056]); wherein identifying the region of interest comprises: obtaining color/power Doppler data corresponding to the B-mode ultrasound image resulting from the global B-mode gain value ([0029]); identifying the blood vessel in the B-mode ultrasound image resulting from the global B-mode gain value based on the obtained color/power Doppler data ([0030]); and determining the region of interest based on a diameter of the blood vessel and a direction of the blood vessel ([0035]); wherein determining the output B-mode gain value comprises: calculating the contrast-to-noise ratio of the region of interest of the B-mode ultrasound image resulting from the global B-mode gain value ([0057]); and determining the output B-mode gain value by adjusting the global B-mode gain value to result in an increase in the contrast to noise ratio of the region of interest ([0057]); wherein determining the output B- mode gain value comprises: identifying a value of the output B-mode gain value which results in a maximized contrast to noise ratio in the region of interest ([0057]); wherein the ultrasound monitor comprises a wearable ultrasound sensor or an ultrasound patch (as the transducer is configured to be in contact with the patient’s tissue, it may be considered wearable or a patch; [0075]); wherein the ultrasound monitor comprises a one dimensional ultrasonic array ([0075]).
Freiburger fails to show a global image entropy of the B-mode ultrasound image being within a target entropy range. Freiburger also fails to show: calculating the global image entropy of the B-mode ultrasound image; checking if the output B-mode gain value the global image entropy of the B-mode ultrasound image resulting from the output B-mode gain value is within the target entropy range.
Kim discloses techniques for ultrasound image enhancement based on entropy information. Kim teaches a global image entropy of the B-mode ultrasound image being within a target entropy range (compare entropy information with threshold, [0034]). Kim also teaches calculating the global image entropy of the B-mode ultrasound image (calculate entropy information corresponding with the ultrasound data; [0027]-[0033]); checking if the output B-mode gain value the global image entropy of the B-mode ultrasound image resulting from the output B-mode gain value is within the target entropy range (compare entropy information with threshold, [0034])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the gain optimization techniques of Freiburger to utilize entropy information as taught Kim, as entropy information is a known ultrasound diagnostic parameter which correlates with sudden changes which may occur during the imaging procedure as described by Kim ([0005]) and as utilizing entropy information will improve the overall quality of the image by reducing noise as described by Kim ([0039]). It would be an obvious modification of the gain optimization techniques for Freiburger to utilize other known ultrasound imaging parameters such as entropy as taught by Kim, in order to provide a more accurate enhanced image of patient’s tissue.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freiburger et al. (US 2019/0261952; hereinafter Freiburger) in view of Kim et al. (US 2012/0123265; hereinafter Kim) as applied to claim 1 above, and further in view of Tretter (US 6463173).
Freiburger fails to show wherein the obtained B-mode ultrasound image results from an initial B-mode gain value, and wherein determining the global B-mode gain value comprises: plotting a cumulative histogram of image entropy of the B-mode ultrasound image resulting from the initial B-mode gain value; determining the global B-mode gain value by adjusting the initial B-mode gain value, such that a log-average of the image entropy of the B-mode ultrasound image resulting from the global B- mode gain is within the target entropy range; wherein the target entropy range is a range of log-averages of the cumulative histogram, the range of log-averages selected such that a common carotid artery, CCA, of corresponding B-mode ultrasound images may be detected.
Tretter discloses systems and methods for histogram-based image contrast enhancement. Tretter teaches plotting a cumulative histogram of image entropy of the B-mode ultrasound image resulting from the initial B-mode gain value; determining the global B-mode gain value by adjusting the initial B-mode gain value, such that a log-average of the image entropy of the B-mode ultrasound image resulting from the global B- mode gain is within the target entropy range (average log likelihood stored; column 9, lines 30-40); wherein the target entropy range is a range of log-averages of the cumulative histogram, the range of log-averages selected such that a common carotid artery, CCA, of corresponding B-mode ultrasound images may be detected (average log likelihood stored; column 9, lines 30-40).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Freiburger and Kim to utilize mathematical algorithms including histograms and log averages as taught by Tretter, as such mathematical algorithms are known within the art of imaging and provide for improved image contrast enhancement as described by Tretter (abstract). Furthermore, in regards to specific anatomy such as the common carotid artery, it is noted that Freiburger additionally teaches imaging of the carotid artery ([0040]), and it would be within the level of one of ordinary skill in the art to adapt the imaging technique for any particular part of the patient’s anatomy as desired by the operator and depending on the patient’s disease state.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freiburger et al. (US 2019/0261952; hereinafter Freiburger) in view of Kim et al. (US 2012/0123265; hereinafter Kim) as applied to claim 8 above, and further in view of Hasegawa (US 2022/0125403).
Freiburger fails to show wherein calculating the contrast- to-noise ratio is based on a difference between an average intensity of pixels in the region of interest corresponding to a tissue wall of the blood vessel and an average intensity of pixels in the region of interest corresponding to a background region, and wherein calculating the contrast-to-noise ratio is further based on a variance of intensity of pixels in the background region of the region of interest.
Hasegawa discloses ultrasound imaging systems and methods. Hasegawa teaches calculating the contrast- to-noise ratio is based on a difference between an average intensity of pixels in the region of interest corresponding to a tissue wall of the blood vessel and an average intensity of pixels in the region of interest corresponding to a background region, and wherein calculating the contrast-to-noise ratio is further based on a variance of intensity of pixels in the background region of the region of interest (estimate signal to noise based on average value and variance, [0027]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Freiburger and Kim to calculate contrast/signal to noise ratio using known statistical measurements such as average and variance as taught by Hasegawa, as a variety of known techniques for calculating a signal to noise ratio are known in the art, and it would be an obvious design choice to one of ordinary skill in the art, without undue experimentation, to select an appropriate manner of calculation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797