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 .
Response to Amendment
The rejection under 35 U.S.C. 112(b) of Claim 16 has been withdrawn in light of the amendment to the claims filed on 17 October 2025.
The objection to the Drawings & Title have been withdrawn in light of the amendment the claims filed on 17 October 2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27 October 2025 are assumed to be in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement are being considered by the examiner. It should be recognized that Applicant has submitted a number of lengthy IDS’s and, while they have fully reviewed, there may be some inaccuracies when evaluating such lengthy IDS’s.
Moreover, the Office has identified a number of references have zero bearing on the claims at hand, as listed below:
US 20200123703 A1: METHOD OF REDUCING FRETTING OF STEEL ROPES AND BELTS;
US 20140276234 A1: INTRAUTERINE MEASUREMENT DEVICE;
US 20130192611 A1: MEDICAL DEVICE FIXATION;
US 20130023981 A1: BARBED ANCHOR;
US 20030216803 A1: Textured And Drug Eluting Stent-grafts;
US 20030125797 A1: Advanced Endovascular Graft;
US 0952161: Non-rotating wire rope; etc
It should be appreciated that not all wholly unrelated references can be exampled above; however, but some of the most apparent candidates have been listed to ensure a complete record. For example, Applicant has submitted a non-rotating wire rope filed in 1906 or a method of reducing fretting of steel ropes and belts.
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, 3-4, 6-8, 10-15, 17-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 is directed to a process which falls into one of the statutory categories; however, the claims recites the following abstract ideas: performing image analysis on the 3D ultrasound image to identify the IVC relative to other anatomical structures, wherein the image analysis includes using edge detection to identify other anatomical structures and identifying the IVC relative to the other anatomical structures; selecting a single slice of the 3D image, the slice comprising a cross- sectional image of the IVC; and determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice.
With regards to Claim 1, 23, & 24, the cited limitations, under their broadest reasonable interpretation, cover performance in the mind. Nothing recited precludes the cited steps from being practically performed in the mind, or with the assistance of basic physical aids, see MPEP § 2106.04(a)(2)(III)( B). In particular, the act of “performing image analysis on the 3D ultrasound image to identify the IVC relative to other anatomical structures.” The act of “selecting a single slice of the three-dimensional image, the slice comprising a cross-sectional image of the IVC” can also be performed manually by visually inspecting an ultrasound image to select a slice depicting a cross-section of the IVC which is routinely performed in a clinical setting. Finally, the act of “determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice” can also be performed manually by splitting the IVC cross-section into regular shapes to calculate the cross-sectional area if the shape is irregular or, if regular, a simple area of a circle formula can be utilized.
The claim as a whole is not integrated into a practical application as established in MPEP § 2106.04(d). The claim recites the additional element of “performing image analysis” which is implied to be associated with a computer processor, it should be appreciated that generically recited computer elements do not add a meaningful limitation to the abstract idea because they merely generically link the use of the judicial exception to a particular technological environment and not more. Furthermore, neither the instant specification nor the claim provide an ordered combination of elements to improve the functioning of a computer or improves any other technology in the field because they amount using computers merely as a tool (see MPEP § 2106.05(a)(I)). Similarly, the acts of “selecting a single slice of the three-dimensional image, the slice comprising a cross-sectional image of the IVC” & “determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice” do not add a meaningful limitation to the abstract idea because they merely generically link the use of the judicial exception to a particular technological environment and not more and do not provide an ordered combination of elements to improve the functioning of a computer or improves any other technology in the field because they amount using computers merely as a tool. The use of an ultrasound transducer only generally links the ac the use of a judicial exception to a particular technological environment or field of use (see MPEP § 2106.04(d)(I)).
Moreover, the act of “wherein the image analysis includes using edge detection to identify other anatomical structures and identifying the IVC relative to the other anatomical structures” could be performed manually by visually inspecting an ultrasound image to identify edges of anatomical structures and the IVC which is routinely performed in a clinical setting” and is recited at such a high level of generality that it amounts to the computer being used to perform an abstract idea such that it amounts to no more than mere instructions to apply the exception using a generic computer (see MPEP 2106.05(f)). More specifically, the steps are presented at such a high level of generality that it amounts to a results-oriented solution that lacks detail as to how the computer performed the modifications in an attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result (see MPEP § 2106.05(f)(1)).
Furthermore, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract ideas recited as laid out in MPEP § 2106.05. In particular, the act of “obtaining a plurality of 2-dimensional (2D) images…“ and “providing a three-dimensional, 3D, ultrasound image of a portion of the body in which the IVC is located” amounts to mere data gathering, and thus is insignificant extra-solution activity (see MPEP § 2106.05(g)).
In consideration of each of the relevant factors and the claim elements both individually and in combination, Claim 1 directed to abstract ideas without sufficient integration into a practical application and without significantly more. The dependent claims do not sufficiently link the subject matter to a practical application or recite element(s) which constitute significantly more than the abstract ideas identified. More specifically, the depending claims are directed toward additional limitations which either:
encompass abstract ideas consistent with those identified above, for example:
Claim 6: “identifying at least one anatomical structure in the image selected from the group containing the aorta, the renal arteries, the hepatic vein, the right atrium or the diaphragm” could be performed manually by visually inspecting an ultrasound image to identify any one of the aorta, the renal arteries, the hepatic vein, the right atrium or the diaphragm which is routinely performed in a clinical setting;
Claim 6: “identifying the IVC in the image by its known position relative to the identified anatomical structure” could be performed manually by visually inspecting an ultrasound image to identify the IVC relative to any one of the aorta, the renal arteries, the hepatic vein, the right atrium or the diaphragm which is routinely performed in a clinical setting;
Claim 7: “wherein identifying at least one anatomical structure in the image comprises the use of Doppler data to identify the direction and velocity of blood flow” could be performed manually by visually inspecting a Doppler flow image to recognize the direction readily available flow vectors which is routinely performed in a clinical setting;
Claim 8: “wherein identifying at least one anatomical structure in the image comprises the use of known geometric properties of the at least one anatomic structure” could be performed manually by visually inspecting an ultrasound image to recognize the shape of the at least one anatomic structure which is routinely performed in a clinical setting;
With regards to Claim 10: “verifying the identification of the IVC in the 3D ultrasound image using an additional metric selected from a group comprising Doppler velocity, direction of blood flow, pulsitility, distances, pulmonary B-line measurements and audio respiratory data” could be performed manually by visually inspecting a Doppler ultrasound image to recognize the direction from readily available flow vectors which is routinely performed in a clinical setting;
With regards to Claim 11: “wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises using edge detection techniques to identify the wall of the IVC” could be performed manually by visually inspecting an ultrasound image to determine edges in ultrasound images which are regions abrupt color changes which indicate a boundary which is routinely performed in a clinical setting;
With regards to Claim 12: “wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises the fitting of an ellipse to the IVC in the cross-sectional image” could be performed manually by estimating/drawing an ellipse that resembles the shape of the IVC;
Claim 19: “determining at least one of minimum area, mean area, and maximum area of the IVC from the graph” could be performed manually by visually inspecting the corresponding graph and noting the max, min, mean, zero point {i.e. collapsibility};
Claim 20: “further comprising comparing at least one of the determined minimum area, mean area, and maximum area of the IVC to a threshold to record an event” comparing collected information to a predefined threshold is an act of evaluating information that can be practically performed in the human mind;
Claim 21: “whereby the series of measurements are analysed to identify trends or fluctuations against an allowable tolerance over a period of time” could be performed manually by visually inspecting the corresponding graph and recognizing simple trends and thresholds;
fail to integrate the abstract idea into a practical application, for example:
With regards to Claim 13: “wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises the use of thresholding techniques” is presented at such a high level of generality that it amounts to a results-oriented solution that lacks detail as to how the computer performed the modifications in an attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result (see MPEP § 2106.05(f)(1));
Claim 14: “further comprising the use of blob detection and analysis techniques to determine the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice” is presented at such a high level of generality that it amounts to a results-oriented solution that lacks detail as to how the computer performed the modifications in an attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result (see MPEP § 2106.05(f)(1));
Claim 22: “wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises the use of a neural network to mark the IVC in the ultrasound image” is presented at such a high level of generality that it amounts to a results-oriented solution that lacks detail as to how the computer performed the modifications in an attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result; or
fail to add significantly more than the abstract idea, for example:
Claim 3: “wherein the plurality of 2D ultrasound images are obtained by a body-worn ultrasound transducer array” merely specifies the nature of the data which is exploited when executing the abstract ideas (see MPEP § 2106.05(g)(3));
Claim 4: “wherein the plurality of 2D ultrasound images are obtained by the body-worn ultrasound transducer array from a plurality of directions or locations on the body” merely specifies the nature of the data which is exploited when executing the abstract ideas (see MPEP § 2106.05(g)(3));
Claim 15: “wherein the steps of providing, performing, selecting and determining are repeated over time to obtain a series of measurements” amounts to mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity (see MPEP § 2106.05(g));
Claim 17: “wherein the selected single slice differs between subsequent measurement time points in the series of measurements due to movement of the IVC during respiration” merely specifies the nature of the data which is exploited when executing the abstract ideas (see MPEP § 2106.05(g)(3)); and
Claim 18: “further comprising plotting the series of measurements against time in a graph” encompasses the presentation of printed materials to a user which amounts to an insignificant application (see MPEP § 2106.(g)(3)).
It follows that the cited claims are directed to abstract ideas without sufficient integration into a practical application and without significantly more, and thus fails to meet the requirements of 35 U.S.C. 101.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-4, 6-8, 10-15, 17-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may "express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted). This can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015), see MPEP § 2161(I).
With regards to Claim 1, the claim recites “performing image analysis on the 3D ultrasound image to identify the IVC relative to other anatomical structures, wherein the image analysis includes using edge detection to identify other anatomical structures and identifying the IVC relative to the other anatomical structures”; however, the instant specification fails to explain the steps/procedure for “identify[ing] the IVC relative to other anatomical structures,” “using edge detection to identify other anatomical structures,” and “identifying the IVC relative to the other anatomical structures, ” i.e. computer function, in sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. More specifically, ¶ [0108] discloses the step of identifying the IVC; however, the instant specification fails to provide any explicit steps as to how the function of identifying the IVC achieves this goal as intended by the inventor. In other words, the instant specification merely discloses what the corresponding algorithm does without providing explicit details how the algorithm achieves the goal. One of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended the function to be performed. Since the instant specification fails to provide a finite sequence of steps for performing the “performing image analysis on the 3D ultrasound image to identify the IVC relative to other anatomical structures,” the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
While ¶ [0108] discloses the identifying anatomical landmarks using edge detection, the instant specification fails to disclose how the edge detection results in an anatomical structure identification. More specifically, edge detection in image processing is well-known in the art; however, classification of an object, e.g. anatomical landmark, based on edge detection techniques is not a trivial matter. Since the instant specification is devoid of any explicit classification steps which classifies the detected edges as anatomical landmark, the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
Dependent claims are rejected by virtue of their dependency to abovementioned claims.
Similarly, Claim 6 recites “identifying at least one anatomical structure in the image selected from the group containing the aorta, the renal arteries, the hepatic vein, the right atrium or the diaphragm” & “identifying the IVC in the image by its known position relative to the identified anatomical structure”; however, the instant specification fails to explain the steps/procedure for identifying at least one anatomical structure in the image selected from the group containing the aorta, the renal arteries, the hepatic vein, the right atrium or the diaphragm” & “identifying the IVC in the image by its known position relative to the identified anatomical structure,” i.e. computer function, in sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. While ¶ [0108] discloses the step of identifying the aorta, the renal arteries, the hepatic vein, the right atrium or the diaphragm and the IVC relative thereto, the instant specification fails to provide and explicit steps as how the identifying function achieves this goal as intended by the inventor.
Since the instant specification fails to provide a finite sequence of steps for performing “identifying at least one anatomical structure in the image selected from the group containing the aorta, the renal arteries, the hepatic vein, the right atrium or the diaphragm” & “identifying the IVC in the image by its known position relative to the identified anatomical structure,” the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
Claim 8 recites similar limitations and are rejected under the same rationale as claim 6. Dependent claims are rejected by virtue of their dependency to abovementioned claims.
With regards to Claim 22, the claim recites “wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises the use of a neural network to mark the IVC in the ultrasound image” ; however, the instant specification fails to explain the steps/procedure for identifying anatomical structures based on edge detection techniques, i.e. computer function, in sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. While ¶ [0074, 0139, & 0181-0183] merely mention training machine learning algorithm such as a neural network {it should be appreciated that the mentioned U-net is used for binarization and not IVC marker}, the instant specification fails to provide any specific details regarding the neural network that would inform one of ordinary skill in the art of the functionality of the algorithm as intended by the inventor. For example, the instant specification is devoid any details regards type of neural network (e.g. convolution, recurrent, generative adversarial, transformer, etc.); Initial conditions (e.g. weights and biases), kernels; transfer/activation functions; types of layers (e.g. dense layers, pooling, fully connected, activation/ReLu, batch normalization layers, convolutional, dropout layers); architecture; and the like. Accordingly, the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 102
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 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 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, 3-4, 6-8, 10-11, 13, 15, & 17-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barnard et al. (US PGPUB 20130303915; hereinafter "Barnard").
With regards to Claim 1, Barnard discloses a method of determining measurements of the Inferior Vena Cava, IVC, using ultrasound imaging (automated 3D ultrasound abdominal vessel monitor capable of monitoring the IVC; see Barnard Abstract), comprising:
obtaining a plurality of 2-dimensional (2D) images of a portion of the body in which the IVC is located from an ultrasound device, wherein the ultrasound device includes an ultrasound transducer comprising a 2D array of independently controllable transducer elements for producing an ultrasonic pulse, a power source for providing an electrical signal to the ultrasound transducer, and a beam former (3D ultrasound abdominal vessel monitor can utilize one or more transducers {i.e. a 2D ultrasound array}, swept mechanically or electronically to create the desired scan planes; see Barnard ¶ [0070]; one of ordinary skill in the art would recognize that electronically sweeping an ultrasound beam inherently requires independently controlled transducer elements for beam forming1; The control and processing system 460 may further include transmit and timing control circuitry to control aperture and focusing of the ultrasound pressure waves {i.e. beamforming}; see Barnard ¶ [0077]));
providing a three-dimensional, 3D, ultrasound image of a portion of the body in which the IVC is located (automated 3D ultrasound abdominal vessel monitor capable of monitoring the IVC; see Barnard Abstract) by combining the plurality of 2D images into a three-dimensional, 3D, ultrasound stack (The 3D ultrasound abdominal vessel monitor may be positioned so the transducer(s) sweeps to create multiple simultaneous transverse or sagittal image planes, providing a 3D dataset from a point where the IVC meets the heart to approximately 2-8 cm inferior to that point; see Barnard ¶ [0007]; it should be appreciated that one of ordinary skill in the art would recognize that a 3D dataset is formed from 2D image planes via combining the images into a volume, i.e. a 3D ultrasound stack);
performing image analysis on the 3D ultrasound image to identify the IVC relative to other anatomical structures (performing image analysis on the 3D volumetric FoV; see Barnard ¶ [0084]), wherein the image analysis includes using edge detection to identify other anatomical structures (using Sobel filters for edge detection to identify vessel; see Barnard ¶ [0084]) and identifying the IVC relative to the other anatomical structures (identifying the IVC & aorta via heuristics according to their relative position {i.e. next to each other} and the direction of blood flow; see Barnard ¶ [0087]);
selecting a single slice of the three-dimensional image, the slice comprising a cross- sectional image of the IVC (measure a cross-sectional area of the inferior vena cava at different cross-sections {i.e. selecting a single slice}; see Barnard ¶ [0028]); and
determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice (measure a cross-sectional area of the inferior vena cava at different cross-sections {i.e. selecting a single slice}; see Barnard ¶ [0028]).
With regards to Claim 31, Barnard discloses wherein the plurality of 2D ultrasound images are obtained by a body-worn ultrasound transducer array (self-adhered ultrasound abdominal vessel monitoring device 100; see Barnard ¶ [0059]).
With regards to Claim 43, Barnard discloses wherein the plurality of 2D ultrasound images are obtained by the body-worn ultrasound transducer array from a plurality of directions or locations on the body (the ultrasound transducer 16 is configured to sweep {i.e. obtaining images from a plurality of directions}; see Barnard ¶ [0076]).
With regards to Claim 61, Barnard discloses wherein performing image analysis on the 3D ultrasound image to identify the IVC relative to other anatomical structure comprises:
identifying at least one anatomical structure in the image selected from the group containing the aorta, the renal arteries, the hepatic vein, the right atrium or the diaphragm (calculating a diameter of the aorta as well; see Barnard ¶ [0031]); and
identifying the IVC in the image by its known position relative to the identified anatomical structure (identifying the IVC & aorta via heuristics according to their relative position {i.e. next to each other} and the direction of blood flow; see Barnard ¶ [0087]).
With regards to Claim 76, Barnard discloses wherein identifying at least one anatomical structure in the image comprises the use of Doppler data to identify the direction and velocity of blood flow (identifying the IVC & aorta via heuristics according to their relative position {i.e. next to each other} and the direction of blood flow; see Barnard ¶ [0087]; wherein blood flow is identified via Doppler color flow; see Barnard ¶ [0083]).
With regards to Claim 87, Barnard discloses wherein identifying at least one anatomical structure in the image comprises the use of known geometric properties of the at least one anatomic structure (monitoring the shape {i.e. known geometric property} of the IVC over time; see Barnard ¶ [0010]).
With regards to Claim 101, Barnard discloses further comprising verifying the identification of the IVC in the 3D ultrasound image using an additional metric selected from a group comprising Doppler velocity, direction of blood flow, pulsitility, distances, pulmonary B-line measurements and audio respiratory data (identifying the IVC & aorta via heuristics according to their relative position {i.e. next to each other} and the direction of blood flow; see Barnard ¶ [0087]; wherein blood flow is identified via Doppler color flow; see Barnard ¶ [0083]).
With regards to Claim 111, Barnard discloses wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises using edge detection techniques to identify the wall of the IVC (scan planes are transmitted to form the 3D volume; see Barnard ¶ [0026]; the IVC diameter is determined from the 3D reconstruction; see ¶ [0036]; it should be appreciated that Barnard still determines the CSA based on the cross-sectional images indirectly via 3D volumes).
With regards to Claim 131, Barnard discloses wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises the use of thresholding techniques (The Sobel filter identifies “edges” or large first derivatives in the data; see Barnard ¶ [0084]; it should be appreciated that one of ordinary skill in the art would understand “large first derivatives” as a threshold to filter out the derivatives less than the “large” standard, i.e. a threshold).
With regards to Claim 151, Barnard discloses wherein the steps of providing, performing, selecting and determining are repeated over time to obtain a series of measurements (the display can further present a graphical representation of a relative change in diameter of the IVC over time; see Barnard ¶ [0032]).
With regards to Claim 1715, Barnard discloses wherein the selected single slice differs between subsequent measurement time points in the series of measurements due to movement of the IVC during respiration (measuring the diameter of the IVC across multiple respiratory cycles to determine max & min diameters; see Barnard ¶ [0026]).
With regards to Claim 1815, Barnard discloses further comprising plotting the series of measurements against time in a graph (the display can further present a graphical representation of a relative change in diameter of the IVC over time; see Barnard ¶ [0032]).
With regards to Claim 1918, Barnard discloses further comprising determining at least one of minimum area, mean area, and maximum area of the IVC from the graph (measuring the diameter of the IVC across multiple respiratory cycles to determine max & min diameters; see Barnard ¶ [0026]; measuring degree of collapse; see Barnard ¶ [0011-0020]).
With regards to Claim 2019, Barnard discloses further comprising comparing at least one of the determined minimum area, mean area, and maximum area of the IVC to a threshold to record an event (The processing subsystem can assess a roundness of the inferior vena cava by comparing multiple diameter measurements at different cross-sections in real time to differentiate collapse from simply reduced diameter; see Barnard ¶ [0028]; wherein the reduced diameter amounts to a threshold).
With regards to Claim 2115, Barnard discloses whereby the series of measurements are analysed to identify trends or fluctuations against an allowable tolerance over a period of time (monitoring IVC parameters {e.g. CI-IVC, CVP, heart rate, respiration} over time; see Barnard ¶ [0081]).
With regards to Claim 231, Barnard discloses a computer program product comprising instructions which, when the program is executed by a computer, cause the computer to carry out the method of Claim 1 (processing system 460 includes storage medium 466 with instructions; see ¶ [0078]).
With regards to Claim 241, Barnard discloses a computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to carry out the method of claim 1 (processing system 460 includes storage medium 466 with instructions; see ¶ [0078]).
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 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.
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Barnard in further view of Karami et al. (“Semi-Automatic Algorithms for Estimation and Tracking of AP-Diameter of the IVC in Ultrasound Images,” (9 January 2019), J. Imaging 2019, 5(1), 12; hereinafter "Karami").
With regards to Claim 121, while Barnard discloses determining roundness & shape of the IVC (see Barnard ¶ [0028 & 0079]), it appears that Barnard may be silent to wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises the fitting of an ellipse to the IVC. However, Karami teaches of tracking the AP-diameter of the IVC with an ellipse fitting algorithm (see Karami Abstract & § 3.1; it should be appreciated that calculating the CSA from the diameter is trivial as taught by Barnard, detailed above, and Karam see pg. 2, ¶ 2 & 4 along with pg. 13, ¶ 2).
Barnard and Karami are both considered to be analogous to the claimed invention because they are in the same field of quantifying the IVC via ultrasound imaging. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barnard to incorporate the above teachings of Karami to provide at least an ellipse fitting algorithm to determine the CSA of the IVC. Doing so would aid in accurately modelling the diameter of the IVC to guide fluid administration/removal (see Karami pg. 2, ¶ 5 & Abstract).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Barnard and Karami in further view of Udupa et al. (US PGPUB 20170091574; hereinafter "Udupa").
With regards to Claim 1412, while Barnard disclose determining the shape of the IVC (see Barnard ¶ [0079]), it appears that Barnard may be silent to further comprising the use of blob detection and analysis techniques to determine the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice. However, Udupa teaches of automatic anatomy recognition in medical imaging such as ultrasound image (see Udupa Abstract & ¶ [0202]). More specifically, Udupa teaches of further comprising the use of blob detection and analysis techniques to determine the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice (the AAR detects blob-like and tubular objects such as the inferior vena cava; see Udupa ¶ [0021, 0039, & 0079]).
Barnard and Udupa are both considered to be analogous to the claimed invention because they are in the same field of anatomical recognition in medical imaging. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barnard to incorporate the above teachings of Udupa to provide at least blob detection and analysis techniques. Doing so would aid in significantly improved consistency of anatomic localization (see Barnard ¶ [0022]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Barnard in further view of Garcia (US PGPUB 20230277157; having an effective filing date of 9 September 2020) .
With regards to Claim 221, while Barnard discloses all of the limitations of intervening claim 1 as shown above, it appears that Barnard may be silent to wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises the use of a neural network to mark the IVC in the ultrasound image. However, Garcia teaches of an ultrasound system and method for tracking a cross-section geometry, including tracking the cross-sectional area of the IVC (see Garcia Abstract & ¶ [0045]). More specifically, Garcia teaches of wherein determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises the use of a neural network to mark the IVC in the ultrasound image (an initialization algorithm may utilize a convolutional neuronal network {i.e. neural network} previously trained using a plurality of ultrasound images of vessel cross-sections labeled by trained subjects; see Barnard ¶ [0046]).
Barnard and Garcia are both considered to be analogous to the claimed invention because they are in the same field of IVC quantification in ultrasound imaging. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barnard to incorporate the above teachings of Garcia to provide at least determining the cross-sectional area of the IVC from the cross-sectional image of the IVC in the selected slice comprises the use of a neural network to mark the IVC in the ultrasound image. Doing so would aid in tracking small changes in cross-section geometry associated with hypertension, hemorrhage, etc. and can quantify stroke volume, stroke volume variation, cardiac output, etc. (see Garcia ¶ [0036]).
Response to Arguments
Applicant's arguments filed 17 October 2025 with regards to the rejection under 35 U.S.C. 101 have been fully considered but they are not persuasive.
In particular, Applicant contends that the claims are statutory under 35 U.S.C. 101. In support Applicant argues that the claimed steps “constitute a specific technique for accurately measuring IVC cross-sectional area using three-dimensional ultrasound imaging technology.” While the Office does not disagree with the Applicant’s position, such an argument does not counter the fact that said steps can be performed practically in the mind as laid out above.
Applicant also argues that “performing image analysis on the 3D ultrasound image to identify the IVC relative to other anatomical structures" limitation requires computational analysis of complex three-dimensional ultrasound data that cannot be practically performed manually.” The Office disagrees. The act of image analysis is presented at such a high level of generality that it amounts to a results-oriented solution that lacks detail as to how the computer performed the modifications in an attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result (see MPEP § 2106.05(f)(1)). For example, edge detection algorithms only find regions of different contrast and connected pixels to delineate edges of structures in images. One of ordinary skill in the art would recognize that edge detection algorithms identify edges and not anatomical structures. In order to classify the identified edges, the algorithm must employ a classification algorithm which the instant specification fails to disclose. Therefore, the image analysis steps amount to a mere instructions to apply an exception without claiming details how the results are accomplished. For at least this reason, Applicant’s arguments are not persuasive.
Applicant also argues that “the step of "selecting a single slice of the three-dimensional image" from a 3D ultrasound dataset requires computer processing to extract specific cross-sectional data from the volumetric image data. It is not possible to select a single slice of a 3D image in the mind.” The Office disagrees. 35 U.S.C. 101 does not preclude the use of computer to perform mental processes (see MPEP § 2106.04(a)(2)(III)(C). For example, selecting a cross-section in a 3D volume can be performed manually using and 3D view application to isolate a single image or a slice. For at least this reason, Applicant’s arguments are not persuasive.
Applicant also argues that “amended claim 1 requires acquiring 2D images with an ultrasound device, which plainly cannot be performed in the mind.” The Office disagrees. Acquiring 2D images was clearly identified as insignificant data gathering. For at least this reason, Applicant’s arguments are not persuasive. Applicant also argues that “Applicant has further amended claim 1 to indicate that the 3D image is obtained by combining the 2D ultrasound images into a 3D ultrasound stack, which is also not possible to perform as a mental process.” The Office disagrees. Concatenating 2D image sets manually with the use of a generic purpose computer is well known in the art and can be formed with most 3D visualization programs and mathematically with a matrix calculator.
Applicant also argues that “the claim as a whole is integrated into a practical application because it is specifically directed to improving ultrasound imaging technology for medical diagnosis. The method provides a technological solution for automated measurement of IVC cross-sectional area, which addresses the technical problem of providing such measurements for clinical assessment.” The Office disagrees. The instant specification fails to provide “provide details regarding the manner in which the invention accomplished the alleged improvement” (see MPEP § 2106.05(a). More specifically, the act of merely automating a manual activity is not sufficient detail such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. For example, is the claim method more accurate than a practitioner performing the same process?
For at least this reason, Applicant’s arguments are not persuasive and the rejection under 35 U.S.C. 101 is still maintained.
Applicant's arguments filed 17 October 2025 with regards to the rejection under 35 U.S.C. 112(a) have been fully considered but they are not persuasive.
In particular, Applicant contends that the claims conform to the written description requirement under 35 U.S.C. 112(a).
In support, Applicant argues that “the Specification provides specific guidance regarding the identification of the IVC from the acquired images, including the steps of identifying the IVC relative to other anatomical structures by identifying at least one anatomical structure in the image such as the aorta, the renal arteries, the hepatic vein, the right atrium or the diaphragm, and then identifying the IVC in the image by its known position relative to the identified anatomical structure. These anatomical landmarks in the image may be found by the use of Doppler data to identify the direction and velocity of blood flow and/or based on comparison to geometric properties of the anatomic structures and edge detection” (emphasis added). The Office disagrees. As noted above, edge detection algorithms find regions of different contrast and connected pixels to delineate edges of structures in images. One of ordinary skill in the art would understand that the detected edges must be classified in order to identify anatomical structures.
Applicant also argues that “The identification of the IVC in the image may also involve steps applying other information including Doppler velocity, direction of blood flow, pulsatility, distances, pulmonary B-line measurements and audio respiratory data.” The Office disagrees. According to MPEP § 2161.01(I), “The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” While these parameters may be related to the IVC, one of ordinary skill in the art would understand that there are complex relationships to be evaluated via trial an error to identify their relationships in order to be relied upon to algorithmically the IVC. However, the instant specification provides no details regarding their relationships beyond the mention of said parameters. For example, how is pulsitility algorithmically related to detected edges such that the algorithm can identify the IVC? Moreover, there is no obvious or well-known method in the art that relates some or all of said parameters to identify the IVC in a 3D US images. For at least this reason, Applicant’s arguments are not persuasive.
With regards to Claims 6 & 8, Applicant cites "[T]he patent specification is written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before. Placed in that context, it is unnecessary to spell out every detail of the invention in the specification; only enough must be included to convince a person of skill in the art that the inventor possessed the invention and to enable such a person to make and use the invention without undue experimentation." The Office disagrees. The same case, LizardTech, as establishes that “(“The purpose of [the written description requirement] is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification”); LizardTech Inc. v. Earth Resource Mapping Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005) (“Whether the flaw in the specification is regarded as a failure to demonstrate that the patentee [inventor] possessed the full scope of the invention recited in [the claim] or a failure to enable the full breadth of that claim, the specification provides inadequate support for the claim under [§ 112(a)]”).” Applicant has not established the scope of the algorithm and acts to exclude any and all permutations of IVC detection in 3D US volumes.
Moreover, “In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method.” Similarly, Applicant claims a generic method for IVC detection via edge detection according to some combination of various parameters and, similarly, is deemed invalid under 35 U.S.C. 112(a) because Applicant aims to “to claim any and all means for achieving that objective.” LizardTech, 424 F.3d at 1346, 76 USPQ2d at 1733.
With regards to Claims 3-4 & 22, Applicant’s arguments are persuasive.
Applicant's arguments filed 17 October 2025 with regards to the rejection under 35 U.S.C. 102(a)(1) have been fully considered but they are not persuasive.
In particular, Applicant contends that Barnard does not disclose “combining a plurality of 2D ultrasound images into a 3D ultrasound stack” The Office disagrees. In ¶ [0007], Barnard discloses “The 3D ultrasound abdominal vessel monitor may be positioned so the transducer(s) sweeps to create multiple simultaneous transverse or sagittal image planes, providing a 3D dataset from a point where the IVC meets the heart to approximately 2-8 cm inferior to that point.” In other words, Barnard acquires a plurality of 2D images which form a 3D dataset. One of ordinary skill in the art would recognize that it is notoriously well known in the art that a 3D dataset is formed from 2D image planes via combining the images into a volume, i.e. a 3D ultrasound stack.
Applicant also argues that Barnard does not disclose “selecting a single slice of a 3D image.” The Office disagrees. A diameter and cross-sectional area are 2D measurements. One of ordinary skill in the art would recognize that “measur[ing] a diameter of the inferior vena cava in multiple orientations around the inferior vena cava” requires isolating a 2D representation {at the various orientations} in order to calculate the diameter. Therefore, Barnard inherently discloses selecting a single slice otherwise Applicant’s interpretation would render Barnards disclosure as non-functional. There is no way for Barnard to measure a 2D cross-sectional area without selection a 2D image from which the diameter and cross-sectional area are derived from. For at least this reason, Applicant’s arguments are not persuasive.
With regards to dependent claims, Applicant relies on the virtue of their dependency upon abovementioned independent claim 1 to argue novelty. Accordingly, said argument is not persuasive for at least the same reasons as Claim 1 as detailed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798
1 https://en.wikipedia.org/w/index.php?title=Phased_array_ultrasonics&oldid=1025020939