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 .
Priority
Acknowledgement is made of Applicant’s claim of priority from Foreign Application No. KR10-2023-0049665, filed April 14, 2023.
Information Disclosure Statement
The information disclosure statement (“IDS”) filed on May 1, 2025 was reviewed and the listed references were noted.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a system, method, and non-transitory computer-readable medium for correcting a blood flow velocity calculation. Consider method claim 1:
Step 1:
With regard to Step 1, the instant claim is directed to a method or a process; and therefore, the claim is directed to one of the statutory categories of invention.
Step 2A, Prong One:
With regard to 2A, Prong One, the limitations “determining, using the plurality of medical images, a blood flow velocity of the target blood vessel” and “correcting, based on the electrocardiogram data and standard blood flow velocity data of the target blood vessel, the blood flow velocity” as drafted, recite an abstract idea, such as a process that, under its broadest reasonable interpretation, covers performance of the limitations manually and in the mind of a person. That is, a user or person skilled in the art may use a formula to determine a blood flow velocity from images and determine a correction factor to apply to the calculated blood flow velocity based on electrocardiogram data and standard blood flow velocity data using mathematical calculations. This is the concept that falls under the grouping of abstract ideas mathematical concepts, i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations.
Step 2A, Prong Two:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional step or a combination of additional steps in the claim to apply, rely on, or use the judicial exception. In the instant case, the additional steps of “receiving a plurality of medical images depicting a target blood vessel”, “receiving electrocardiogram data of an object of measurement” and “displaying an indication of the corrected blood flow velocity” is considered to be extra-solution activity of gathering and outputting information. In addition, with respect to the system and computer-readable medium claims of claims 9 and 10, the mere recitation of a generic processor, memory, or storage medium to perform/store programming instructions of the recited/identified abstract idea does not integrate the identified abstract idea into a practical application. Accordingly, the above-mentioned additional elements/limitations do not integrate the abstract idea into a practical application; and therefore, the independent claims recite an abstract idea.
Step 2B:
Because the claims fail under Step 2A, the claims are further evaluated under Step 2B. The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because as discussed above with respect to integration of the abstract idea into practical application, the additional elements/limitations to perform the recited steps, amount to no more than insignificant extra-solution activity. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. Therefore, independent claims 1 and 10 are not patent eligible. In addition, claims 2-9 and 11-17 of the instant application provide limitations that both individually or in combination do not integrate the identified abstract idea into a practical application or provide significantly more than the identified abstract idea.
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.
Claims 1-5, 8-14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schormans et al. (US 11,694,339 B2).
Regarding claim 1, Schormans teaches a method for correcting blood flow velocity, the method being performed by one or more processors and comprising:
receiving a plurality of medical images depicting a target blood vessel (Col. 9, lines 8-18, the embodiment uses X-ray angiographic image analysis to determine average blood velocity in a targeted blood vessel or vessel of interest. Therefore, subtraction angiographic frames (i.e., medical images depicting a target blood vessel) and ECG signal corresponding with the X-ray angiographic image run are preferred for the optimal performance of the blood velocity determination method);
receiving electrocardiogram data of an object of measurement (Col. 9, lines 8-18, the embodiment uses X-ray angiographic image analysis to determine average blood velocity in a targeted blood vessel or vessel of interest. Therefore, subtraction angiographic frames and ECG signal corresponding with the X-ray angiographic image run (i.e., electrocardiogram data of an object of measurement) are preferred for the optimal performance of the blood velocity determination method);
determining, using the plurality of medical images, a blood flow velocity of the target blood vessel (Col. 12, lines 36-60, given the contrast agent presence in both frames, this is combined with the time interval between the frames to generate a velocity in the blood vessel between the two marked endpoints:
v
l
o
c
a
l
=
s
2
-
s
1
t
2
-
t
1
where
v
l
o
c
a
l
is the velocity measured over the vessel segment between the contrast fronts in the given input frames);
correcting, based on the electrocardiogram data and standard blood flow velocity data of the target blood vessel, the blood flow velocity (Col. 13 line 50 – Col. 14 line 43, in different sections of the heart phase the
v
l
o
c
a
l
value can therefore be an over- or under estimation as related to the average blood velocity of the patient. Therefore, the
v
l
o
c
a
l
needs to be corrected to an average velocity value
v
m
e
a
n
over an entire heart cycle (22 within FIG. 9). For this translation method (FIG. 1, S5), the generic full velocity profile is used. The full velocity profiles can be obtained from different patients for instance through a database and have corresponding ECG signals (i.e., standard blood flow velocity data of the target blood vessel). The correlation factor is based on a normalized integral over the part of the heart cycle covered:
c
f
=
∫
0
1
f
(
x
)
/
∫
s
t
a
r
t
e
n
d
f
(
x
)
e
n
d
-
s
t
a
r
t
where f(x) represents the generic full velocity profile and start and end are the start and end frame times within the normalized heart cycle [0,1]. The interval spanned between the start and end frame can be linked to an interval relative to the detected R peaks (i.e., based on electrocardiogram data). The average velocity can then be calculated as:
v
m
e
a
n
=
v
l
o
c
a
l
c
f
(i.e., correcting the blood flow velocity)); and
displaying an indication of the corrected blood flow velocity (Col. 8, line 26-28, the user interface module can include different kinds of input and output devices, such as a display screen for visual output. Claim 1, displaying information to a user, wherein the information characterized blood flow in the blood vessel, and wherein the information is based on at least one of the local flow velocity and the average flow velocity (i.e., corrected blood flow velocity)).
Regarding claim 2, Schormans teaches the method according to claim 1, and further teaches wherein the correcting the blood flow velocity comprises:
determining a correction factor for correcting the blood flow velocity of the target blood vessel (Col. 13 line 50 – Col. 14 line 43, the correlation factor (i.e., correction factor) is based on a normalized integral over the part of the heart cycle covered:
c
f
=
∫
0
1
f
(
x
)
/
∫
s
t
a
r
t
e
n
d
f
(
x
)
e
n
d
-
s
t
a
r
t
where f(x) represents the generic full velocity profile and start and end are the start and end frame times within the normalized heart cycle [0,1]. The interval spanned between the start and end frame can be linked to an interval relative to the detected R peaks); and
applying the correction factor to the blood flow velocity of the target blood vessel so as to correct the blood flow velocity (Col. 13 line 50 – Col. 14 line 43, the average velocity can then be calculated as:
v
m
e
a
n
=
v
l
o
c
a
l
c
f
(i.e., applying the correction factor to the blood flow velocity)).
Regarding claim 3, Schormans teaches the method according to claim 2, wherein the plurality of medical images comprise a first medical image and a second medical image, and
the determining the correction factor comprises:
determining, from the standard blood flow velocity data, a first average velocity of a standard blood flow velocity of the target blood vessel, wherein the first average velocity is based on an average value per heart rate cycle of the object of measurement (Col. 13 line 50 – Col. 14 line 43, a generic full profile f(x) for one heart cycle matched to the generic ECG signal (i.e., f(x) is the first average velocity));
determining a second average velocity that is based on an average value of a standard blood flow velocity of the target blood vessel between a time associated with the first medical image and a time associated with the second medical image (Col. 13 line 50 – Col. 14 line 43, the correlation factor (i.e., correction factor) is based on a normalized integral over the part of the heart cycle covered:
c
f
=
∫
0
1
f
(
x
)
/
∫
s
t
a
r
t
e
n
d
f
(
x
)
e
n
d
-
s
t
a
r
t
(i.e.,
∫
s
t
a
r
t
e
n
d
f
(
x
)
is the second average velocity between a time associated with the first medical image and a time associated with the second medical image)); and
determining, using the first average velocity and the second average velocity, the correction factor (Col. 13 line 50 – Col. 14 line 43, the correlation factor (i.e., correction factor) is based on a normalized integral over the part of the heart cycle covered:
c
f
=
∫
0
1
f
(
x
)
/
∫
s
t
a
r
t
e
n
d
f
(
x
)
e
n
d
-
s
t
a
r
t
).
Regarding claim 4, Schormans teaches the method according to claim 1, further comprising mapping the standard blood flow velocity data to the electrocardiogram data such that a cycle of the standard blood flow velocity data matches a heart rate cycle of the electrocardiogram data (Col. 13, lines 30-39, plotting in a graph for example all
v
l
o
c
a
l
values calculated using for instance a single frame difference between frame A and frame B subsequent for all the frames within a full cardiac cycle, represents the velocity change during the cardiac cycle as contrast agent propagates through the target vessel, further known as ‘full velocity profile’. This results in a generic full profile f(x) for one heart cycle matched to the generic ECG signal (i.e., electrocardiogram data)).
Regarding claim 5, Schormans teaches the method according to claim 1, and further teaches wherein the plurality of medical images comprise a first medical image and a second medical image, and
the determining the blood flow velocity of the target blood vessel comprises:
determining a distance between a first point in the target blood vessel where a contrast agent reaches in the first medical image and a second point in the target blood vessel where the contrast agent reaches in the second medical image (Col. 12, lines 34-53,
v
l
o
c
a
l
=
s
2
-
s
1
t
2
-
t
1
, where
s
1
is the distance measured in the first frame (frame A),
s
2
is the distance measured in the second frame (frame B) (i.e.,
s
2
-
s
1
is the distance the contrast travelled between the first point and second point);
determining a time interval between a time associated with the first medical image being captured and a time associated with the second medical image being captured (Col. 12, lines 34-53,
v
l
o
c
a
l
=
s
2
-
s
1
t
2
-
t
1
,
t
1
is the timestamp of the start of acquisition of the first frame, and
t
2
is the timestamp of the start of acquisition of the second frame (i.e.,
t
2
-
t
1
is the time interval between first medical image being captured and second medical image being captured)); and
determining, using the determined distance and the determined time interval, the blood flow velocity of the target blood vessel (Col. 12, lines 34-53,
v
l
o
c
a
l
=
s
2
-
s
1
t
2
-
t
1
, where
v
l
o
c
a
l
is the velocity measured over the vessel segment between the contrast fronts in the given input frames).
Regarding claim 8, Schormans teaches the method according to claim 1, wherein the target blood vessel is one of right coronary artery (RCA), left anterior descending artery (LAD), or left circumflex artery (LCX) (Col. 10, lines 23-57, for the different coronary arteries (e.g., left coronary artery, right coronary artery, coronary circumflex, etc.) the moment of minimal coronary velocity can occur at a different moment within the cardiac cycle. By using specific delays, it is possible to enable optimal contrast injection specific for the coronary artery of interest (i.e., coronary artery of interest is left coronary artery, right coronary artery, or coronary circumflex)).
Claim 9 recites a computer-readable storage medium storing a program with instructions corresponding to the steps recited in Claim 1. Therefore, the recited programming instructions of this claim are mapped to the proposed reference in the same manner as the corresponding steps in its corresponding method claim. Additionally, the Schormans reference discloses a computer readable storage medium (Col. 23, lines 48-56, code embodied on a non-transitory machine-readable medium).
Claims 10-14 and 17 recite systems with elements corresponding to the steps recited in Claims 1-5 and 8, respectively. Therefore, the recited elements of these claims are mapped to the proposed reference in the same manner as the corresponding steps in their corresponding method claims. Additionally, the Schormans reference discloses a communication interface, a memory, and a processor (Col. 24, lines 52-the example computer system includes a processor, a main memory and a network interface device).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable Schormans et al. (US 11,694,339 B2) in view of Liu et al. (US 2022/0151579 A1).
Regarding claim 6, Schormans teaches the method according to claim 5, as described above.
Although Schormans teaches determining a time interval between the first medical image and second medical image (Schormans, Col. 12, lines 34-53), Schormans does not explicitly teach “wherein the time interval is determined based on, within the plurality of medical images, a number of frames between the first medical image and the second medical image, and a number of frames per second”. However, in an analogous field of endeavor, Liu teaches determining an average blood flow velocity using
V
h
=
L
N
/
f
p
s
, where L represents a length of the blood vessel through which a contrast agent flows in the heartbeat cycle region; N represents the number of frames of the coronary angiogram images contained in the heartbeat cycle region; and fps represents the number of frames transmitted per second (i.e., time interval is determined based on number of frames in the cycle and a number of frames per second) (Liu, Equation [00001] and Paras. [0023]-[0025]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Schormans with the teachings of Liu by including determining the time interval based on the number of frames in the cycle and the number of frames transmitted per second. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for evaluating a function state of artery circulation, as recognized by Liu. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Claim 15 recites a system with elements corresponding to the steps recited in Claim 6. Therefore, the recited elements of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Schormans and Liu references, presented in rejection of Claim 6, apply to this claim. Finally, the combination of the Schormans and Liu references discloses a communication interface, a memory, and a processor (Schormans, Col. 24, lines 52-the example computer system includes a processor, a main memory and a network interface device).
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable Schormans et al. (US 11,694,339 B2) in view of Schmidt et al. (US 2023/04104123 A1).
Regarding claim 7, Schormans teaches the method according to claim 1, as described above.
Although Schormans teaches a generic full velocity profile (i.e., standard blood flow velocity data). (Schormans, Col. 13 line 50 – Col. 14 line 43), Schormans does not explicitly teach “wherein the standard blood flow velocity data is data that is standardized based on at least one of age, gender, race, height, weight, presence or absence of cardiovascular disease, obesity (BMI), blood pressure, or smoking status of the object of measurement”. However, in an analogous field of endeavor, Schmidt teaches an appropriate standard or control can be the blood flow velocity and/or coagulation of blood obtained from a subject who is identified as not having the condition or disease. An “appropriate standard” is a parameter, value or level indicative of a known outcome, status or result (e.g., a known disease or condition status). For example, an appropriate standard may be the flow or adherence characteristic of a blood cell obtained from a subject known to have a disease, or a subject identified as being disease-free (Schmidt, Paras. [0125]-[0126]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the method of Schormans with the teachings of Schmidt by including the standard blood flow velocity is data that is standardized based on presence or absence of cardiovascular disease. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for measuring blood flow velocity for disease detection, as recognized by Schmidt. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Claim 16 recites a system with elements corresponding to the steps recited in Claim 7. Therefore, the recited elements of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Schormans and Schmidt references, presented in rejection of Claim 7, apply to this claim. Finally, the combination of the Schormans and Schmidt references discloses a communication interface, a memory, and a processor (Schormans, Col. 24, lines 52-the example computer system includes a processor, a main memory and a network interface device).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emma Rose Goebel whose telephone number is (703)756-5582. The examiner can normally be reached Monday - Friday 7:30-5.
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/Emma Rose Goebel/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
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