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.
Claims 2, 18 and 20 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 a formula without defining all the variables of the formula.
Claims 18 and 20 are rejected for the same reasons as they also claim similar formula.
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.
Claims 1, 4, 5, 7-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lenehan et al (US Pub. 2016/0029972) in view of Naghavi et al (US Pub. 2010/0081941).
With respect to claim 1, Lenehan discloses A diagnostic apparatus comprising: a communications interface; a memory storing instructions; and at least one processor coupled to the communications interface and to the memory, the at least one processor being configured to execute the instructions to perform operations (see figure 15, numerical 104 and 1504 for communication interface) comprising:
receiving measurement data of a response to a flow-mediated dilation (FMD) test, (see paragraph 0032, wherein … receive information and detected data from the diagnostic device 102);
determining an FMD parameter value based on the received measurement data, wherein the FMD parameter value quantifies an arterial wall's ability to recover from the FDM test, (see paragraph 0040, wherein … FMD determination module 203 can be configured to determine a parameter indicative of a patient's FMD in a limb arterial blood vessel… Parameters indicative of a patient's FMD can include maximum percent arterial dilation post-occlusion compared with pre-occlusion (%FMDmax), time (e.g., from cuff release following occlusion) to %FMDmax, 60-second FMD, or 90-second FMD, for example. %FMDmax can be determined from the maximum percent change in blood volume post-occlusion vs. pre-occlusion…);
establishing a diagnostic threshold based on patient medical information, (see figures 6, 8, 10 and 12, and paragraph 0059, wherein …table in FIG. 6 can be used to provide CVD risk “diagnostic threshold” categories based on FMD-adjusted vascular age. For example, … labeled 602 can be identified as low CVD risk according to FMD-adjusted vascular age, the region labeled 604 can be identified as intermediate CVD risk according to FMD-adjusted vascular age, and the region labeled 606 can be identified as high CVD risk…);
determining a diagnostic result of the FMD test by comparing the FMD parameter value to the diagnostic threshold, (see figure 6 and paragraph 0059 wherein …For example, … labeled 602 can be identified as low CVD risk according to FMD-adjusted vascular age, the region labeled 604 can be identified as intermediate CVD risk according to FMD-adjusted vascular age, and the region labeled 606 can be identified as high CVD risk…);
providing the diagnostic result of the FMD test and
However, Lenehan fails to explicitly disclose determining a treatment based on the diagnostic result; and providing the diagnostic result of the FMD test and the recommended treatment through an output module of the diagnostic apparatus (emphasis added) ,as claimed.
Naghavi teaches determining a treatment based on the diagnostic result; and providing the diagnostic result of the FMD test and the recommended treatment through an output module of the diagnostic apparatus (emphasis added, see paragraph 0063, wherein … In an embodiment, the remote data management center can monitor and analyze the reported results and communicate back to the CPU to provide recommendations and/or alterations of medical treatment such as dispensing and/or alterations of drug prescriptions…; and also see figure 3B, Monitor/GUI for display), as claimed.
It would have been obvious to one ordinary skilled in the art at the effective date of invention to combine the two references as they are analogous because they are solving similar problem of cardiovascular health assessment using image analysis. Teachings of Naghavi to communicate back the recommendations of the medical treatment can be incorporated in to the Lenehan system (see figure 15 numerical; 1504 communication link) and modifying the system yields a more user friendly system that outputs not only the diagnostics but also the treatment (see Naghavi Abstract), for motivation.
With respect to claim 4, combination of Lenehan and Naghavi further discloses the FMD parameter value comprises a patient-specific measurement resulting from the FMD test, (see Lenehan paragraph 0040, wherein … The FMD determination module 203 can be configured to determine a parameter indicative of a patient's FMD in a limb arterial blood vessel, such as the brachial artery…), as claimed.
With respect to claim 5, combination of Lenehan and Naghavi further discloses receiving the measurement data comprises: receiving image data of a patient from a medical diagnostic tool; and deriving the measurement data from the received image data, (see Lenehan paragraph 0032, wherein … The diagnostic computer 104 can provide control signals to the diagnostic device 102 and receive information and detected data from the diagnostic device 102; and paragraph 0040, wherein ...For example, %FMDmax can be determined by using a pneumoplethysmograph without sensors or via vascular ultrasonography by using an ultrasound imager), as claimed.
With respect to claim 7, combination of Lenehan and Naghavi further discloses the diagnostic threshold comprises a static threshold or a dynamic threshold, (see Lenehan paragraph 0064, wherein …mobile device 1512 can be used to provide real-time updates of a person's vascular age based on regularly or continuously updated CVD risk data. In addition, the mobile app can allow a user to track his or her CVD risk data and vascular age over time…), as claimed.
With respect to claim 8, combination of Lenehan and Naghavi further discloses the patient information corresponds to at least one of age, family medical history, smoking history, and sex, (see Lenehan paragraph 0039, wherein … CVD risk data can include Framingham Heart Study (FHS) multi-year risk scores, European Systemic Coronary Risk Evaluation (SCORE) values, or other clinicopathologic input data, including chronological age, gender, body mass index, systolic blood pressure, resting heart rate, breath flow analysis, smoking status, presence or absence of diabetes, blood glucose level and/or hemoglobin Alc, HDL cholesterol, total cholesterol, other lipid measures, carotid artery intima--media wall thickness (CIMT) detected via ultrasound, pulse wave velocity/amplitude waveform analysis, brachial artery ultrasound imaging, fingertip temperature analysis, pedometer data, sleep patterns, stress levels, blood-based biomarkers, genomic data, and other metrics related to longevity…), as claimed.
With respect to claim 9, combination of Lenehan and Naghavi further discloses the at least one processor is further configured to execute the instructions to perform operations comprising: retrieving medical history of a patient of the FMD test; and determining the FMD parameter value based on the medical history and measurement data, (see Lenehan paragraph 0044, wherein …FMD can be measured at 1310 as the maximal FMD detected at any time interval after hyperemia induction, the percent dilation at any specified time interval after hyperemia induction (e.g., 60-second %FMD), or the time it takes to reach %FMDmax from the start of hyperemia. induction. At 1312, vascular age values obtained from pre-existing or newly created CVD scoring systems (e.g. Framingham Heart Study or European SCORE project) can be modified by the FMD data measured at step 1310 to produce FMD-modified vascular age values…), as claimed.
With respect to claim 10, combination of Lenehan and Naghavi further discloses the measurement data comprises a change in diameter of an artery subject to the FMD test, (see Lenehan claim 10), as claimed.
With respect to claim 11, combination of Lenehan and Naghavi further discloses the FMD test is a brachial artery flow-mediated dilation test, (see Lenehan paragraph 0031, wherein …the artery that is being evaluated is described as the brachial artery…), as claimed.
With respect to claim 12, combination of Lenehan and Naghavi further discloses the diagnostic threshold comprises a range of thresholds corresponding to the patient medical information (see Lenehan paragraph 0059, wherein …CVD risk categories [this is read as ranges of diagnostic thresholds] based on FMD-adjusted vascular age [is read as encompassing patient FMD results and cardiovascular risk]), and wherein providing the diagnostic result through the output module further comprises presenting a graphical representation of the range of thresholds and a marker denoting the diagnostic result, the marker being presented within the graphical representation in relation to the range of thresholds (see Naghavi figure 4, GUI “output module”, and paragraph 0062, wherein …graphs and data analysis results …are available on the GUI…), as claimed.
With respect to claim 13, combination of Lenehan and Naghavi further discloses the diagnostic result comprises a prediction in a physical status of a patient of the respective FMD test, (see Lenehan paragraph 0009, wherein …FMD-adjusted vascular age calculator can be used to diagnose a person's potential for developing cardiovascular disease), as claimed.
Claims 14-17 are rejected for the same reasons as set forth in the rejection of claims 1, 4, 7 and 9, because claims 14-17 are claiming subject matter of similar scope as claimed in claims 1, 4, 7 and 9 respectively. Furthermore, Lenehan discloses image data (see Lenehan paragraph 0039, wherein …brachial artery ultrasound imaging…; and claim 20 ultrasound imager), as claimed in claim 14.
Claim 19 is rejected for the same reasons as set forth in the rejection of claim 1, because claim 19 is claiming subject matter of similar scope as claimed in claim 1. Furthermore, Lenehan discloses image data (see Lenehan paragraph 0039, wherein …brachial artery ultrasound imaging…; and claim 20 ultrasound imager), as claimed in claim 19.
Claims 2, 18 and 20 as understood are rejected under 35 U.S.C. 103 as being unpatentable over Lenehan et al (US Pub. 2016/0029972) in view of Naghavi et al (US Pub. 2010/0081941) as applied to claim 1 above, and further in view of The Relationship Between Vascular Wall Shear Stress and Flow-Mediated Dilation: Endothelial Function Assessed by Phase-Contrast Magnetic Resonance Angiography, by Silber et al.
With respect to claim 2, combination of Lenehan and Naghavi discloses all the elements as claimed and as rejected in claim 1 above. However, they fail to explicitly disclose the FMD parameter value is
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where is a property indicative of the artery's responsiveness to a changing shear stress, as claimed.
Silber teaches the relationship between the FMD and shear stress of the artery, see title page section Background wherein … Furthermore, FMD is greater in small arteries, though the reasons for this phenomenon are unclear.., this is read as FMD is inversely proportional to the shear stress, as claimed.
Therefore, it would have been obvious to one ordinary skilled in the art at the effective date of invention to combine the two references as they are analogous because they are solving similar problem of cardiovascular health assessment using image analysis. Teachings of Silber, the relationship between FMD and shear stress can be incorporated in to Lenehan system as suggested (see Lenehan paragraph 0040), for suggestion, and modifying the system yields a more accurate output from the diagnostic system (see Silber Objectives), for motivation.
Claims 18 and 20 are rejected for the same reasons as set forth in the rejection of claim 2, because claims 18 and 20 are claiming subject matter of similar scope as claimed in claim 2.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lenehan et al (US Pub. 2016/0029972) in view of Naghavi et al (US Pub. 2010/0081941) as applied to claim 1 above, and further in view of Fully-Automatic Method for Assessment of Flow-Mediated Dilation, by Zielinski et al.
With respect to claim 3, combination of Lenehan and Naghavi discloses all the elements as claimed and as rejected in claim 1 above. However, they fail to explicitly disclose the at least one processor is further configured to execute the instructions to perform operations comprising: applying at least one of a machine learning processing or neural network processing to adjust one or more algorithms used to determine the FMD parameter value, as claimed.
Zielinski teaches applying at least one of a machine learning processing or neural network processing to adjust one or more algorithms used to determine the FMD parameter value, (see section 6 Discussion, wherein, we have presented a method which fully-automatically analyses the ultrasound video and returns the FMD value…), as claimed.
Therefore, it would have been obvious to one ordinary skilled in the art at the effective date of invention to combine the two references as they are analogous because they are solving similar problem of cardiovascular health assessment using image analysis. Teachings of Zielinski to use a fully automatic method can be incorporated in to Lenehan and Naghavi system as suggested (see Lenehan figure 2 processor), for suggestion, and modifying the system will yield a more reliable diagnostic process (see Zielinski Abstract), for motivation
With respect to claim 6, combination of Lenehan, Naghavi and Zielinski further discloses the received image data is ultrasound imagining data, (see Lenehan paragraph 0039, wherein …brachial artery ultrasound imaging…), as claimed.
Conclusion
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/VIKKRAM BALI/Primary Examiner, Art Unit 2663
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