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 9 and 18 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.
Regarding claims 9 and 18, the limitations “arterial pressure” and “measurements of the arterial pressure” render the claim indefinite because it is unclear whether this is the same or different from the blood pressure measurements recited in claims 1 and 11, respectively. For the present purposes of examination, they have been interpreted as being the same. Further clarification is required.
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Analysis step 1 of Subject Matter Eligibility Test
The claims are directed to a machine (i.e., an ultrasound system) of claims 1-10, a process (i.e., a method of operation for an ultrasound system) of claims 11-19, and a manufacture (i.e., a tangible, non-transitory computer-readable medium) of claim 20.
Analysis step 2A, Prong I
The claims recite abstract ideas, in particular mathematical concepts and mental processes- concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Claim 1 recites “determine changes in response of the vasculature wall tissue between the two-dimensional ultrasound image sequences at the different times as the pressure is variably applied to the subject; determine, based on the blood pressure measurements and the changes in response of the vasculature wall tissue between the two-dimensional ultrasound image sequences as the pressure is variably applied, a non-linear elastic relationship between strains in vasculature wall tissue captured in the two-dimensional ultrasound image sequences and varying stresses to which the vasculature wall tissue is subjected based on subject-specific blood pressure” which are mathematical concepts. Claim 1 also recites “detect an aneurysmal state of the vasculature wall tissue based on the non-linear elastic relationship and the changes in response of the vasculature wall tissue between the two-dimensional ultrasound image sequences as the pressure is variably applied” which is a mental process- a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Independent claim 11 and 20 recite analogous limitations.
Claim 2 further defines the limitations of claim 1. Claim 3 recites “determine within each acquired two-dimensional ultrasound image sequence, diastolic frames in which aortic diameter or circumference is minimum, and systolic frames in which aortic diameter is maximum” which is a mathematical concept. Claim 4 recites “determine a difference between the first aortic diameter or circumference and the second aortic diameter or circumference; and determine the changes in response of the vasculature wall tissue as the pressure is variably applied based on the difference between the first aortic diameter or circumference and the second aortic diameter or circumference” which are mathematical concepts. Claim 5 further defines the limitations of claim 1. Claim 6 recites “determine the non-linear elastic relationship between strains in vasculature wall tissue captured in the two-dimensional ultrasound image sequences and varying stresses to which the vasculature wall tissue is subjected based on a combination of externally applied probe pressure variably applied to the subject and the subject-specific blood pressure” which is a mathematical concept. Claim 6 also further defines the aneurysmal state. Claim 7 recites “obtain an index indicating the loss of elasticity based on measuring the cyclic variations in aortic diameter or circumference of the vasculature walls” which is a mathematical concept. Claim 8 further defines limitations. Claim 9 recites “determine the non-linear elastic relationship also based on measurements of the arterial pressure from the sensor” which is a mathematical concept. Claim 10 recites “determine a relationship between pressure and aortic diameter or circumference of the vasculature walls; extract constants of a non-linear hyperelastic material model based on the relationship to characterize the vasculature wall tissue” which is a mathematical concept. Claims 12- 19 recite analogous limitations.
Analysis step 2A, Prong II
The judicial exception is not integrated into a practical application because the additional elements of the claim are mere instructions to implement an abstract idea on a computer and the additional elements of the claims merely add insignificant extra-solution activity to the judicial exception. See MPEP 2106.05 (f) and (g).
Claims 1, 11, and 20 recite a memory and a processor. These additional elements result in mere instructions to implement an abstract idea on a computer. Claims 1, 11, and 20 also recite “receive time-resolved two-dimensional ultrasound image sequences of vasculature walls in vasculature wall tissue captured at different times as pressure is variably applied to a subject of the two-dimensional ultrasound image sequences; receive blood pressure measurements of the subject” which is insignificant extra-solution activity, in particular mere data gathering. Claim 4 recites “measure a first aortic diameter or circumference of the vasculature walls at a first time, corresponding to a diastolic frame; measure a second aortic diameter or circumference of the vasculature walls at a second time corresponding to a systolic frame subsequent to the first time” which is insignificant extra-solution activity, in particular mere data gathering. Claim 7 recites “measure cyclic variations in aortic diameter or circumference of the vasculature walls” which is insignificant extra-solution activity, in particular mere data gathering. Claim 9 recites “a sensor for measuring arterial pressure” which is insignificant extra-solution activity, in particular mere data gathering. The claims dependent on independent claim 11 recite analogous additional elements.
Analysis step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the memory and processor are additional elements that merely results in instructions to implement an abstract idea on a computer that is well-understood, routine, and conventional activity previously known to the industry. The remaining additional elements merely add insignificant extra-solution activity, in particular mere data gathering, to the judicial exception that are well-understood, routine, and conventional activities previously known to the industry and merely indicate a field of use or technological environment in which to apply the judicial exception.
Claims 1-20 are therefore directed to a judicial exception without significantly more. The claims are not patent eligible.
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.
Claims 1-4, 6-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bracco, M.I. et al., "Aortic Wall Stiffness Depends on Ultrasound Probe Pressure,"arXiv:2312.07980v1, 2023, retrieved from https://arxiv.org/abs/2312.07980, 20 pages (applicant submitted prior art via the IDS) in view of Rouet et al. (EP 3914161A1, December 12, 2021, applicant submitted prior art via the IDS, citations correspond to WO 2020/151965 A1 which is attached).
Regarding claims 1, 11, and 20, Bracco discloses an ultrasound system (and corresponding method and tangible, non-transitory computer-readable medium) for aneurysmal state detection (“Assessing the biomechanical behaviour of the aortic wall in vivo can potentially improve the diagnosis and prognosis of patients with abdominal aortic aneurysms (AAA). With ultrasound, AAA wall stiffness can be estimated as the diameter change in response to blood pressure.” Abstract, objective; also see “Philips EPIQ scanner” in section 2.1.1), comprising:
receive time-resolved two-dimensional ultrasound image sequences of vasculature walls in vasculature wall tissue captured at different times as pressure is variably applied to a subject of the two-dimensional ultrasound image sequences (“Two-dimensional ultrasound sequences were acquired from AAA patients, alternatively applying light and firm probe pressure.” Abstract, method; also see Figs. 1 and 5, reproduced below, and corresponding descriptions);
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receive blood pressure measurements of the subject (“Brachial pressure was recorded just before each US scanning procedure.” Section 2.1.1);
determine changes in response of the vasculature wall tissue between the two-dimensional ultrasound image sequences at the different times as the pressure is variably applied to the subject (“All the cine-loops from the 10 patients (9 males, 1 female), aged from 63 to 86, were successfully processed. The main results for all the patients are presented in Figure 4. The application of FPP resulted in a decrease of the systolic AP diameter between 1.02 mm and 6.84 mm, depending on the patient. Conversely, an increase of the relative diameter change was observed in all cases except one, where a small decrease of ΔD/DDIAS was detected.” Section 3.1; also see Fig. 4, reproduced below, and corresponding description);
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determine, based on the blood pressure measurements and the changes in response of the vasculature wall tissue between the two-dimensional ultrasound image sequences as the pressure is variably applied, a non-linear elastic relationship between strains in vasculature wall tissue captured in the two-dimensional ultrasound image sequences and varying stresses to which the vasculature wall tissue is subjected based on subject-specific blood pressure (“The aortic wall tissue was modelled as a nonlinear fiber-reinforced hyperelastic anisotropic material” section 2.2.4; also see “The arterial stiffness was defined as the dimensionless quantity β = ln(PSYS/PDIAS)/(∆D/DDIAS), where PSYS and PDIAS were obtained from the brachial pressure measurement. Such definition expresses the arterial strain as the fractional (or relative) diameter change (7).” Section 2.1.3; also see “A finite element model (FEM) was created to simulate aortic mechanics during an US scanning procedure. A commercial software (ABAQUS Inc.) was employed for modelling the geometry, meshing and simulating the loads and boundary conditions.” Section 2.2; also see Fig. 2, reproduced below, and corresponding description); and
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detect an aneurysmal state of the vasculature wall tissue based on the non-linear elastic relationship and the changes in response of the vasculature wall tissue between the two-dimensional ultrasound image sequences as the pressure is variably applied (“Assessing the biomechanical behaviour of the aortic wall in vivo can potentially improve the diagnosis and prognosis of patients with abdominal aortic aneurysms (AAA).” Abstract; also see Discussion section).
Although a memory and processor are implicitly part of the ultrasound scanner (Philips EPIQ scanner” in section 2.1.1), Bracco does not explicitly disclose a memory that stores instructions; and a processor that executes the instructions, wherein, when executed by the processor, the instructions cause the ultrasound system to.
However, Rouet teaches, in the same field of endeavor, a memory that stores instructions; and a processor that executes the instructions, wherein, when executed by the processor, the instructions cause the ultrasound system to (“there is provided a computer program comprising computer program code means which is adapted, when said computer program is run on a computer, to implement the method described above.” page 5, ll. 25-30; also see “If a computer program is discussed above, it may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware” page 21, ll. 14-17).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Bracco with a memory that stores instructions; and a processor that executes the instructions, wherein, when executed by the processor, the instructions cause the ultrasound system to as taught by Rouet in order to automate the procedure.
Regarding claims 2 and 12, Bracco further discloses wherein the vasculature walls comprise aortic walls (“Aortic Wall Stiffness” Title) of an abdominal aorta of the subject (“patients with abdominal aortic aneurysms” Abstract), and the changes in response of the vasculature walls as the pressure is variably applied comprise changes in aortic diameter or circumference variation in the aortic walls (“the presented study has elucidated that PP has a significant influence on both diameter variations and in vivo estimated stiffness of the aortic wall” Conclusions section).
Regarding claim 3, Bracco further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: determine within each acquired two-dimensional ultrasound image sequence, diastolic frames in which aortic diameter or circumference is minimum, and systolic frames in which aortic diameter is maximum (“Then, the AP diameter was automatically detected, and the evolution of the AP diameter throughout the sequence was used to detect the diastolic and systolic peaks in the cine-loops. This analysis allowed obtaining diastolic and systolic AP diameters and the relative diameter variation ΔD/DDIAS averaged over multiple cardiac cycles.” Section 2.1.2; also see Fig. 7, reproduced below, and corresponding description).
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Regarding claims 4 and 13, Bracco further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: measure a first aortic diameter or circumference of the vasculature walls at a first time, corresponding to a diastolic frame; measure a second aortic diameter or circumference of the vasculature walls at a second time corresponding to a systolic frame subsequent to the first time; determine a difference between the first aortic diameter or circumference and the second aortic diameter or circumference (“the AP diameter was automatically detected, and the evolution of the AP diameter throughout the sequence was used to detect the diastolic and systolic peaks in the cine-loops. This analysis allowed obtaining diastolic and systolic AP diameters and the relative diameter variation ΔD/DDIAS averaged over multiple cardiac cycles.” Section 2.1.2); and determine the changes in response of the vasculature wall tissue as the pressure is variably applied based on the difference between the first aortic diameter or circumference and the second aortic diameter or circumference (“This increased stress is a function of the material's elasticity and strain, which can be expressed through relative diameter variation ΔD/DDIAS. Therefore, ΔD/DDIAS is expected to increase as the radius of curvature increases, e.g. in the case of FPP.” Discussion section; also see e.g., Table 2, reproduced below, and corresponding description).
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Regarding claims 6 and 15, Bracco further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: determine the non-linear elastic relationship between strains in vasculature wall tissue captured in the two-dimensional ultrasound image sequences (“The aortic wall tissue was modelled as a nonlinear fiber-reinforced hyperelastic anisotropic material” section 2.2.4; also see “This increased stress is a function of the material's elasticity and strain, which can be expressed through relative diameter variation ΔD/DDIAS. Therefore, ΔD/DDIAS is expected to increase as the radius of curvature increases, e.g. in the case of FPP.” Discussion section) and varying stresses to which the vasculature wall tissue is subjected based on a combination of externally applied probe pressure variably applied to the subject and the subject-specific blood pressure (“The first acquisition was performed by applying minimal force, allowing an optimal visualisation of the AAA (light probe pressure, LPP). The second acquisition was conducted using the maximum transducer pressure that the patient could tolerate without major discomfort and that would still allow optimal AAA visualization (firm probe pressure, FPP). In both acquisitions, the PP and hand position were maintained throughout the scanning time. The patient was allowed to breathe between the two acquisitions. Brachial pressure was recorded just before each US scanning procedure.” Section 2.1.1); and detect as the aneurysmal state a loss of elasticity in the vasculature walls of the subject due to pathological state (“To augment the existing maximum diameter criterion, supplementary assessments of aortic elastic properties have been suggested, including the aortic stiffness, which is defined as the difference between systolic and diastolic blood pressures divided by the relative aortic diameter change ΔD/DDIAS , where ΔD is the diameter change between diastole and systole and DDIAS is the diastolic diameter (6–9). Given that aortic wall degeneration during AAA development alters the tissue’s mechanical properties, stiffness has been proposed as a measure of such degeneration, and may indicate the severity of the disease (10).” Introduction section).
Regarding claims 7 and 16, Bracco further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: measure cyclic variations in aortic diameter or circumference of the vasculature walls; and obtain an index indicating the loss of elasticity based on measuring the cyclic variations in aortic diameter or circumference of the vasculature walls (“It was found that half of the AAAs were particularly responsive to the probe pressure: in these patients, the cyclic diameter variation between diastole and systole changed from 1% at light probe pressure to 5% at firm probe pressure and the estimated stiffness decreases by a factor of 6.3.” Abstract, results section; “All the cine-loops from the 10 patients (9 males, 1 female), aged from 63 to 86, were successfully processed. The main results for all the patients are presented in Figure 4. The application of FPP resulted in a decrease of the systolic AP diameter between 1.02 mm and 6.84 mm, depending on the patient. Conversely, an increase of the relative diameter change was observed in all cases except one, where a small decrease of ΔD/DDIAS was detected. By looking at the graph, based on these results, the cases can be split in two classes: five patients showing a net increase in ΔD/DDIAS (from a mean of 1.1 % to 5 %), referred to as the 'responsive cohort' and the other five showing small increase or decrease (from a mean of 1.1 % to 1.4 %), referred to as the 'passive cohort'. The estimated stiffness β decreased on average by a factor of 6.3 in the responsive cohort, and by a factor of 1.5 in the passive cohort.” section 3.1; also see Table 2 and corresponding description).
Regarding claims 8 and 17, Bracco further discloses wherein the two-dimensional ultrasound image sequences are captured at different times in two separate cineloops (“two 10-second 2D US cine-loops were acquired” section 2.1.1), and the cyclic variations in aortic diameter or circumference of the vasculature walls are measured within each of the two separate cineloops (“the AP diameter was automatically detected, and the evolution of the AP diameter throughout the sequence was used to detect the diastolic and systolic peaks in the cine-loops.” Section 2.1.2).
Regarding claims 9 and 18, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Bracco further discloses further comprising: a sensor for measuring arterial pressure (“Brachial pressure was recorded just before each US scanning procedure” section 2.1.1), wherein, when executed by the processor, the instructions cause the ultrasound system further to: determine the non-linear elastic relationship also based on measurements of the arterial pressure from the sensor (“The arterial stiffness was defined as the dimensionless quantity β = ln(PSYS/PDIAS)/(∆D/DDIAS), where PSYS and PDIAS were obtained from the brachial pressure measurement. Such definition expresses the arterial strain as the fractional (or relative) diameter change (7).” Section 2.1.3; also see “A finite element model (FEM) was created to simulate aortic mechanics during an US scanning procedure. A commercial software (ABAQUS Inc.) was employed for modelling the geometry, meshing and simulating the loads and boundary conditions.” Section 2.2). Examiner notes that a sensor for measuring arterial pressure is also taught by secondary reference Rouet (“blood pressure cuff” page 15, ll. 25-30).
Regarding claims 10 and 19, Bracco further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: determine a relationship between pressure and aortic diameter or circumference of the vasculature walls; extract constants of a non-linear hyperelastic material model based on the relationship to characterize the vasculature wall tissue (“The aortic wall tissue was modelled as a nonlinear fiber-reinforced hyperelastic anisotropic material following the formulation by Holzapfel, Gasser and Ogden, also known as the HGO model (23,24). The values of the material constants, defining the AAA wall mechanical behavior, are summarised in Table 1.” Section 2.2.4; also see Table 1 and corresponding description; also see Introduction section).
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bracco in view of Rouet as applied to claims 1 and 11, respectively, above and further in view of Brandl et al. (US 2016/0100823, April 14, 2016).
Regarding claims 5 and 14, Bracco modified by Rouet discloses the limitations of claims 1 and 11, respectively, as stated above but fails to disclose wherein the two-dimensional ultrasound image sequences captured at different times are captured in a single cineloop. Instead Bracco discloses two cineloops (“two 10-second 2D US cine-loops were acquired” section 2.1.1).
However, Brandl teaches, in the same field of endeavor, adjusting a cineloop with varying amounts of data (“However, in some cases, it may be difficult to capture a single heartbeat without including too much data, wherein more than one heartbeat is captured in the cine-loop, or by including too little data, wherein less than one full heartbeat is captured in the cine-loop. Including too much data, or too little data, may result in a stitching artifact wherein images of the cine-loop will appear to jump as the cine-loop nears the end of the cine-loop and begins again at a selected start frame.” [0015]; also see [0027]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Bracco with wherein the two-dimensional ultrasound image sequences captured at different times are captured in a single cineloop as taught by Brandl in order to prevent a stitching artifact ([0015] of Brandl).
Claims 1-7, 9-16, and 18-20 are also alternatively rejected under 35 U.S.C. 103 as being unpatentable over Rouet et al. (EP 3914161A1, December 12, 2021, applicant submitted prior art via the IDS, citations correspond to WO 2020/151965 A1 which is attached) in view of D’Sa et al. (WO 2012/035472, March 22, 2012).
Regarding claims 1, 11, and 20, Rouet discloses an ultrasound system (and corresponding method and tangible, non-transitory computer-readable medium) for aneurysmal state detection (“an ultrasound system” page; also see “An estimation of the blood vessel wall stiffness is a natural biomarker since the rupture of the vessel wall will occur when the wall stress exceeds the wall strength. To estimate wall stress and to characterize the blood vessel wall, a constitutive law of the material needs to be provided. It has been shown that blood vessel walls harboring aneurysms are stiffer than normal aortas, with a lower yield stress (point of fiber rupture).” Page 1, ll. 14-18), comprising:
a memory that stores instructions; and a processor that executes the instructions, wherein, when executed by the processor (“there is provided a computer program comprising computer program code means which is adapted, when said computer program is run on a computer, to implement the method described above.” page 5, ll. 25-30; also see “If a computer program is discussed above, it may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware” page 21, ll. 14-17), the instructions cause the ultrasound system to:
receive time-resolved two-dimensional ultrasound image sequences of vasculature walls in vasculature wall tissue (“obtaining 2D ultrasound data of a blood vessel” page 2, l. 31) captured at different times (“The 2D ultrasound data may be acquired over a period of time, for example, over several cardiac cycles.” Page 13, ll. 31-33);
receive blood pressure measurements of the subject (“obtaining a non-invasive pressure measurement from the subject” page 3, l. 6);
determine changes in response of the vasculature wall tissue between the two-dimensional ultrasound image sequences at the different times (“The method begins in step 110 where 2D ultrasound data of a blood vessel is obtained from a measurement location. The 2D ultrasound data may be obtained using an ultrasound probe such as the one described above with reference to Figure 1. The 2D ultrasound data may be acquired over a period of time, for example, over several cardiac cycles. Due to the high temporal resolution of the 2D ultrasound data, the 2D ultrasound data conveys accurate information relating to the movement of the blood vessel over time. In other words, the change in shape of the blood vessel (i.e. the expansion and contraction over a cardiac cycle) may be extracted from the 2D ultrasound data.” Pages 13, l. 31 – page 14, l. 5).
determine, based on the blood pressure measurements and the changes in response of the vasculature wall tissue between the two-dimensional ultrasound image sequences, a non-linear elastic relationship between strains in vasculature wall tissue captured in the two-dimensional ultrasound image sequences and varying stresses to which the vasculature wall tissue is subjected based on subject-specific blood pressure (“Figure 4 shows a method 300 for generating a measure of rigidity based on the biomechanical model [...] The test blood vessel rigidity is generated based on the non-invasive pressure measurement, the 3D features of the blood vessel taken from the 3D ultrasound data and wall displacement taken from the 2D ultrasound data [...] The test motion is simulated by way of a 2D biophysics model with an embedded constitutive law, which may represent the relationship between the strain and stress of a material as described below with reference to Figure 5. A constitutive law, or equation, is a relation between physical quantities that is specific to a given material or substance. Such a relationship may be used to approximate the response of a given material, such as a blood vessel wall, to an external stimuli. In the case of the blood vessel, the relation between parameters is the stress-strain relationship of the blood vessel wall, and in particular, its behavior in response to the external stimulus of a heartbeat.” Page 18, l. 16 – page 19, l. 3); and
detect an aneurysmal state of the vasculature wall tissue based on the non-linear elastic relationship and the changes in response of the vasculature wall tissue between the two-dimensional ultrasound image sequences as the pressure is variably applied (“Further, an indicator of the vessel rigidity may then be provided to the physician who may then interpret the vessel rigidity and associated aneurism rupture risk.” Page. 19, ll. 9-10).
Although Rouet a variable pressure (In the case of the blood vessel, the relation between parameters is the stress-strain relationship of the blood vessel wall, and in particular, its behavior in response to the external stimulus of a heartbeat.” Page 18, l. 16 – page 19, l. 3), Rouet does not specifically teach pressure is variably applied to a subject of the two-dimensional ultrasound image sequences.
However, D’sa teaches, in the same field of endeavor, pressure is variably applied to a subject of the two-dimensional ultrasound image sequences (“An ultrasonic diagnostic imaging system acquires a sequence of elastography images (elastograms) with a probe as the probe is used to vary the pressure and compress a region of interest of an anatomic mass within the body. A region of interest is identified in one of the images of the acquired sequence of elastograms. The mean change in strain from one image frame to the next within the region of interest is computed over the interval that the region of interest is variably compressed, e.g., from a starting minimum level of pressure to a final maximum level.” Abstract).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rouet with pressure is variably applied to a subject of the two-dimensional ultrasound image sequences as taught by D’sa in order to determine a strain rate that can be used to determine tissue stiffness (Abstract of D’sa).
Regarding claim 2 and 12, Rouet further discloses wherein the vasculature walls comprise aortic walls of an abdominal aorta of the subject (“The graph includes a stress-strain curve for an abdominal aortic aneurism (AAA) and a stress-strain curve for a non- aneurysmal aorta (NAA).” Page 20, ll. 5-10), and the changes in response of the vasculature walls as the pressure is variably applied comprise changes in aortic diameter or circumference variation in the aortic walls (“Currently, the AAA rupture risk is based on aneurysm size (above 55mm in diameter)” page 1, ll. 5-10; also see vessel area in Fig. 6 and corresponding descriptions).
Regarding claim 3, Rouet further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: determine within each acquired two-dimensional ultrasound image sequence, diastolic frames in which aortic diameter or circumference is minimum, and systolic frames in which aortic diameter is maximum (“For example, using the results of the tracking algorithm, one cardiac cycle may be identified where the diastole and systole correspond to the maximum amplitude of vessel motion. Using the selected cardiac cycle, the vessel motion at the measurement location may be computed. The motion can be the motion between diastole and systole, or a model with multiple time samples during the cardiac cycle due to the high temporal resolution of the 2D ultrasound data.” Page 17, ll. 25-34; also see vessel area in Fig. 6 and corresponding descriptions).
Regarding claims 4 and 13, Rouet further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: measure a first aortic diameter or circumference of the vasculature walls at a first time, corresponding to a diastolic frame; measure a second aortic diameter or circumference of the vasculature walls at a second time corresponding to a systolic frame subsequent to the first time; determine a difference between the first aortic diameter or circumference and the second aortic diameter or circumference; and determine the changes in response of the vasculature wall tissue as the pressure is variably applied based on the difference between the first aortic diameter or circumference and the second aortic diameter or circumference (“For example, using the results of the tracking algorithm, one cardiac cycle may be identified where the diastole and systole correspond to the maximum amplitude of vessel motion. Using the selected cardiac cycle, the vessel motion at the measurement location may be computed. The motion can be the motion between diastole and systole, or a model with multiple time samples during the cardiac cycle due to the high temporal resolution of the 2D ultrasound data.” Page 17, ll. 25-34; also see vessel area in Fig. 6 and corresponding descriptions).
Regarding claims 5 and 14, Rouet further discloses wherein the two-dimensional ultrasound image sequences captured at different times are captured in a single cineloop (“the method further comprises generating a cineloop of the blood vessel based on the 2D ultrasound data, wherein the cineloop comprises a plurality of ultrasound image frames of the blood vessel, each acquired at a different moment during a cardiac cycle.” Page 4, ll. 15-18).
Regarding claims 6 and 15, Rouet further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: determine the non-linear elastic relationship between strains in vasculature wall tissue captured in the two-dimensional ultrasound image sequences and varying stresses to which the vasculature wall tissue is subjected based on a combination of externally applied probe pressure variably applied to the subject and the subject-specific blood pressure (“Figure 4 shows a method 300 for generating a measure of rigidity based on the biomechanical model [...] The test blood vessel rigidity is generated based on the non-invasive pressure measurement, the 3D features of the blood vessel taken from the 3D ultrasound data and wall displacement taken from the 2D ultrasound data [...] The test motion is simulated by way of a 2D biophysics model with an embedded constitutive law, which may represent the relationship between the strain and stress of a material as described below with reference to Figure 5. A constitutive law, or equation, is a relation between physical quantities that is specific to a given material or substance. Such a relationship may be used to approximate the response of a given material, such as a blood vessel wall, to an external stimuli. In the case of the blood vessel, the relation between parameters is the stress-strain relationship of the blood vessel wall, and in particular, its behavior in response to the external stimulus of a heartbeat.” Page 18, l. 16 – page 19, l. 3); and detect as the aneurysmal state a loss of elasticity in the vasculature walls of the subject due to pathological state (“An estimation of the blood vessel wall stiffness is a natural biomarker since the rupture of the vessel wall will occur when the wall stress exceeds the wall strength.” Page 1, ll. 14-16; also see page 16, ll. 25-33).
Regarding claims 7 and 16, Rouet further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: measure cyclic variations in aortic diameter or circumference of the vasculature walls (see vessel area over iterations in Fig. 6 and corresponding description; also see “the method further comprises generating a cineloop of the blood vessel based on the 2D ultrasound data, wherein the cineloop comprises a plurality of ultrasound image frames of the blood vessel, each acquired at a different moment during a cardiac cycle.” Page 4, ll. 15-19); and obtain an index indicating the loss of elasticity based on measuring the cyclic variations in aortic diameter or circumference of the vasculature walls (“generating (160) a measure of rigidity based on the biomechanical model” claim 1).
Regarding claims 9 and 18, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Rouet further discloses further comprising: a sensor for measuring arterial pressure (“blood pressure cuff” page 15, ll. 25-30), wherein, when executed by the processor, the instructions cause the ultrasound system further to: determine the non-linear elastic relationship also based on measurements of the arterial pressure from the sensor (“Figure 4 shows a method 300 for generating a measure of rigidity based on the biomechanical model [...] The test blood vessel rigidity is generated based on the non-invasive pressure measurement, the 3D features of the blood vessel taken from the 3D ultrasound data and wall displacement taken from the 2D ultrasound data” page 18, l. 16 – page 19, l. 3).
Regarding claims 10 and 19, Rouet further discloses wherein, when executed by the processor, the instructions cause the ultrasound system further to: determine a relationship between pressure and aortic diameter or circumference of the vasculature walls (“The test blood vessel rigidity is generated based on the non-invasive pressure measurement, the 3D features of the blood vessel taken from the 3D ultrasound data and wall displacement taken from the 2D ultrasound data. In step 320, a test motion of the blood vessel 325 is simulated based on the test blood vessel rigidity. The test motion is simulated by way of a 2D biophysics model with an embedded constitutive law, which may represent the relationship between the strain and stress of a material as described below with reference to Figure 5. A constitutive law, or equation, is a relation between physical quantities that is specific to a given material or substance. Such a relationship may be used to approximate the response of a given material, such as a blood vessel wall, to an external stimuli. In the case of the blood vessel, the relation between parameters is the stress-strain relationship of the blood vessel wall, and in particular, its behavior in response to the external stimulus of a heartbeat. In the present example, the constitutive law has a single parameter to estimate, which is the rigidity of the blood vessel; however, the biomechanical model may be employed to estimate a number of subject parameters of a different constitutive law.” Page 18, ll. 20-32; also see vessel area in Fig. 6 and corresponding descriptions); extract constants of a non-linear hyperelastic material model based on the relationship to characterize the vasculature wall tissue (“As described above, the constitutive law of the biomechanical model may be the relationship between the strain and stress of a material. For the example of the aorta, examples of constitutive laws that have been used include the Mooney-Rivlin law and Yeoh law.” Page 20, ll. 14-18).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rouet in view of D’sa as applied to claims 1, 6-7 and 11, 15-16, respectively, above and further in view of Brandl et al. (US 2016/0100823, April 14, 2016).
Regarding claims 8 and 17, Rouet modified by D’sa discloses the limitations of claims 7 and 16, respectively, as stated above but fails to disclose wherein the two-dimensional ultrasound image sequences are captured at different times in two separate cineloops, and the cyclic variations in aortic diameter or circumference of the vasculature walls are measured within each of the two separate cineloops.
However, Brandl teaches, in the same field of endeavor, adjusting a cineloop with varying amounts of data (“However, in some cases, it may be difficult to capture a single heartbeat without including too much data, wherein more than one heartbeat is captured in the cine-loop, or by including too little data, wherein less than one full heartbeat is captured in the cine-loop. Including too much data, or too little data, may result in a stitching artifact wherein images of the cine-loop will appear to jump as the cine-loop nears the end of the cine-loop and begins again at a selected start frame.” [0015]; also see [0027]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Rouet with wherein the two-dimensional ultrasound image sequences are captured at different times in two separate cineloops, and the cyclic variations in aortic diameter or circumference of the vasculature walls are measured within each of the two separate cineloops as taught by Brandl in order to prevent a stitching artifact ([0015] of Brandl).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 attached.
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/A.A./Examiner, Art Unit 3797
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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