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 .
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 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. A computer program is not a statutory category of invention. Furthermore, 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 § 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.
Claim(s) 1-3, 5, 8-9, 11, and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Errico et al. US 2021/0113190; hereinafter Errico).
Errico shows a computer implemented method and system of processing a contrast-enhanced ultrasound image of a lesion (abstract), the method comprising: comparing properties of the lesion as described in a contrast-enhanced ultrasound report of the contrast-enhanced ultrasound image to a reference in order to determine an inconsistency in the contrast-enhanced ultrasound report ([0043]-[0045], [0056]-[0059]); and sending a message to a user device to cause the user device to provide an alert relating to the inconsistency, to provide feedback ([0062]); wherein the determined inconsistency comprises one of the following: an inconsistency determined between at least two different properties of the lesion with a predefined relationship, the properties of the lesion comprising the at least two different properties of the lesion, the reference comprising the predefined relationship between the at least two different properties ([0043]-[0045]); and an inconsistency determined between the properties of the lesion and the reference, the reference comprising properties of the lesion as measured in a second ultrasound image obtained with a different modality to the contrast enhanced ultrasound image ([0045], [0083]).
Errico also shows wherein the properties of the lesion comprise contrast phase information from the contrast- enhanced ultrasound report ([0043]-[0045]); the reference comprises predefined relationships between different contrast phases according to contrast phase perfusion physiology ([0043]-[0045], [0060]-[0062]); and an inconsistency is determined if the contrast phase information from the contrast- enhanced ultrasound report is inconsistent with the predefined relationships ([0043]-[0045], [0056]-[0059], [0062]); wherein an inconsistency is determined if contrast phases are recorded out of chronological sequence in the contrast- enhanced ultrasound report, or in a physiologically implausible combination (analyzing spatio-temporal variations; [0046]); wherein the second ultrasound image comprises a B-mode image ([0045]); wherein the reference comprises a medical guideline and the method further comprises: obtaining reference properties from the medical guideline wherein the reference properties are associated with a diagnosis in the contrast-enhanced ultrasound report ([0055], [0060], [0082]); and wherein the inconsistency is determined if the properties in the contrast-enhanced ultrasound report are incompatible with the reference properties in the medical guideline, for the diagnosis in the contrast-enhanced ultrasound report ([0055], [0060]); wherein the alert indicates that the properties in the contrast-enhanced ultrasound report are inconsistent with the diagnosis in the contrast-enhanced ultrasound report ([0062]); wherein the method is performed during a contrast-enhanced ultrasound examination, to provide real-time feedback ([0049]).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al. US 2021/0113190; hereinafter Errico).
Errico shows the invention substantially as described in the 102 rejection above.
Errico fails to show wherein the predefined relationships between different contrast phases indicate that: arterial phase onset should be before the peak contrast; if the degree of enhancement of the lesion during the arterial phase is iso-enhancing, then the lesion should present as iso-enhanced or hypo-enhanced during the portal venous phase and/or late phase; if the portal venous phase degree of enhancement of a lesion is iso- enhanced, then the late phase degree of enhancement should be iso-enhancement or hypo-enhancement; if portal venous phase degree of enhancement is iso-enhanced, the degree of washout should be none; and/or if the lesion presents early washout then the portal venous phase degree of enhancement and late phase should only be hypo-enhancement, and degree of washout should be greater than none.
However, Errico describes utilizing contrast enhanced ultrasound to obtain images at various phases including an arterial phase AP, a portal venous phase PVP, and a late phase ([0040]). Errico further describes predefined relationships regarding how each phase provides unique diagnostic information to aid in classifying the lesion, including that the AP may include information regarding the degree of vascularization within a lesion, while the PVP and the late phase may provide information for defining the dynamic washout within the lesion with respect to surrounding tissue, where washout is defined as the transition of hyperenhancement or isoenhancement to hypoenhancement as compared to the adjacent liver parenchyma, and where the enhancement in the late phase may further assist in classifying malignant versus benign masses ([0043]-[0045], [0060]).
It would have been an obvious design choice to one of ordinary skill in the art, to have modified the predefined relationships between phases of Errico to utilize other known or suitably equivalent relationships such as wherein the predefined relationships between different contrast phases indicate that: arterial phase onset should be before the peak contrast; if the degree of enhancement of the lesion during the arterial phase is iso-enhancing, then the lesion should present as iso-enhanced or hypo-enhanced during the portal venous phase and/or late phase; if the portal venous phase degree of enhancement of a lesion is iso- enhanced, then the late phase degree of enhancement should be iso-enhancement or hypo-enhancement; if portal venous phase degree of enhancement is iso-enhanced, the degree of washout should be none; and/or if the lesion presents early washout then the portal venous phase degree of enhancement and late phase should only be hypo-enhancement, and degree of washout should be greater than none; in order to accurately classify the lesion and provide a suitable report regarding the classification of the lesion while accounting for the various properties related to the different phases.
Claim(s) 6-7, 10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al. (US 2021/0113190; hereinafter Errico) in view of Yao et al. (US 2021/0366106; hereinafter Yao).
Errico shows the invention substantially as described in the 102 rejection above.
Errico fails to show wherein the properties of the lesion as described in the contrast-enhanced ultrasound report are geometric properties of the lesion as measured in the contrast-enhanced ultrasound image and the references are values of the same geometric properties as measured in the second ultrasound image; and wherein the inconsistency is determined if the values of the geometric properties of the lesion as measured in the contrast-enhanced ultrasound image are different to the geometric properties of the lesion as measured in the second ultrasound image by more than a threshold difference; wherein the geometric properties comprise a size, radius, diameter, area or circumference of the lesion; receiving user input indicating a particular medical guideline that is to be used; and wherein the reference properties are obtained from the indicated medical guideline; alert suggests in real time that a new contrast-enhanced ultrasound scan is performed due to the inconsistency.
Yao discloses a system and method for confidence-based retroactive discrepancy flagging in medical images. Yao teaches show wherein the properties of the lesion as described in the contrast-enhanced ultrasound report are geometric properties of the lesion as measured in the contrast-enhanced ultrasound image and the references are values of the same geometric properties as measured in the second ultrasound image ([0248], [0253]); and wherein the inconsistency is determined if the values of the geometric properties of the lesion as measured in the contrast-enhanced ultrasound image are different to the geometric properties of the lesion as measured in the second ultrasound image by more than a threshold difference ([0253]-[0258], [0263]); wherein the geometric properties comprise a size, radius, diameter, area or circumference of the lesion ([0248], [0255]-[0258], [0263]); receiving user input indicating a particular medical guideline that is to be used([0097], [0118], [0128], [0286]); and wherein the reference properties are obtained from the indicated medical guideline ([0097], [0118], [0128], [0286]); alert suggests in real time that a new contrast-enhanced ultrasound scan is performed due to the inconsistency ([0117], [0135]).
It would have been an obvious design choice to one of ordinary skill in the art, to have modified the invention of Errico to utilize geometric properties having a threshold difference to aid in determining an inconsistency as taught by Yao, as Yao teaches that comparing the geometric properties of the lesion may provide more precise measurements than those generated by a radiologist’s visual inspection, and may be used to more accurately determine or predict if a patient’s condition is bettering or worsening, to more accurately determine or predict if a patient is responding well or poorly to treatment, and/or to otherwise aid in diagnosing a patient’s condition (Yao [0248]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Choi (US 2013/0169782) describes analyzing ultrasound images to determine the presence of cancer based upon changes in intensity;
Dmitrieva (US 2011/0254842) describes analyzing ultrasound images to determine changes in tumors in 3D;
Igarashi (US 2020/0334818) describes analyzing ultrasound images to determine changes in lesions between phases;
Lin (US 2018/0276821) describes in the background section known relationships between the different phases and the changing stages of a lesion;
Ogasawara (US 2010/0312113) describes generating an animated image to represent blood-vessel dynamics regarding the changing phases and to analyze the shape of the tumor.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797
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