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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on March 2, 2026 is acknowledged.
Claims 11-13 and 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 28, 2026.
Claim Objections
Claims 1, 4 and 7 are objected to because of the following informalities:
In claim 1, in line 8, “a heart” should be changed to – the heart ---.
In claim 1, in line 16, ---at least proximal part of the --- should be inserted before “left atrial appendage”.
In claim 1, in line 18 --- at least proximal part of the --- should be inserted before “left atrial appendage”.
In claim 4, in the second to last line, --peak – should be inserted after “first”.
In claim 7, in the last line “a mitral valve” should be replaced with --- the mitral valve---.
Appropriate correction is required.
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 1-10 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.
With regards to claim 1, in the last line, “a pressure related parameter of the mitral valve” is recited. However, line 1 of the claim refers to determining “a pressure-related value of a mitral valve”, and thus it is unclear as to whether the “pressure related parameter” as set forth in the last line is referring to the same “pressure-related value” as set forth in line 1, or if the above two “pressure related” terms are referring to different elements, thereby rendering the scope of the claim indefinite. For examination purposes, Examiner assumes the former and suggests Applicant use consistent terminology.
Claim 5 recites the limitation "the atrial pressure curve" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the atrial pressure curve" in line 3. There is insufficient antecedent basis for this limitation in the claim.
With regards to claim 8, in line 2, it is unclear as to whether “the segmenting” is referring to the segmenting of the first ultrasound image, the segmenting of the second ultrasound image, as set forth in claim 1, or segmenting of both the first and second ultrasound images. For examination purposes, Examiner assumes that the segmenting can referring to either the segmenting of the first image or of the second image.
With regards to claim 9, in line 3, it is unclear as to whether “the segmentation” is referring to the segmentation of the mitral valve image as set forth in line 3 of claim 9, is referring to the “first segmentation” as set forth in line 16 of claim 1, or is referring to the “second segmentation” as set forth in line 17 of claim 1. For examination purposes, Examiner assumes “the segmentation” is referring to the segmentation of the mitral valve image.
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 1-10 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 device.
The claim(s) recite(s) determine, from the first segmentation, at least one first anatomical measurement relating to the left atrial appendage, determine, from the second segmentation, at least one second anatomical measurement relating to the left atrial appendage, and to derive at least one relation of the at least one first anatomical measurement and the at least one second anatomical measurement. The limitations, as drafted, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor in communication with memory” configured to perform the above steps, nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “the processor” language, “determine, from the first segmentation, at least one first anatomical measurement…”, “determine, from the second segmentation, at least one second anatomical measurement…” and “derive at least one relation..” in the context of this claim encompasses, by viewing on a screen the first/second segmentation, a user mentally measuring a size/length of the left atrial appendage and mentally comparing the first and second anatomical measurements to mentally determine a relation between the at least one first and second anatomical measurements. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites additional elements: 1) a processor in communication with memory, the processor configured to determine the first and second anatomical measurements, etc., 2) obtaining first and second ultrasound images of the heart comprising at least a proximal part of a left atrial appendage at different pressure states and segmenting the first and second ultrasound images to respectively obtain first and second segmentations of at least a part of the left atrial appendage and 3) providing the derived at lest one relation as an indicator for a pressure related parameter of the mitral valve. The processor is recited at a high-level of generality (i.e. a generic processor performing a generic computer function of generating) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Further, the steps of obtaining the first and second ultrasound images and segmenting the first and second images are recited at a high level of generality (i.e. as a means for gathering data for the other steps) and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The step of providing the derived at least one relation is directed to extra solution activity because it is a mere nominal or tangential addition to the claim. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional element of using a processor to perform the functions amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Further, the additional elements of obtaining and segmenting the first and second ultrasound images and providing the derived at least one relation amounts to no more than insignificant extra-solution activity. Mere insignificant extra-solution activity cannot provide an inventive concept. The claims are not patent eligible.
The dependent claims do not appear to patent eligible as the dependent claims appear to be directed to insignificant extra-solution activity as they appear to be further limiting the steps of obtaining and segmenting the first and second ultrasound images (i.e. data-gathering means) [see claims 3-9] or are further limiting what is being provided/outputted [see claims 2 and 10] and thus directed to extrasolution activity because it is a mere nominal or tangential addition to the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ha et al. (“Assessment of Left Atrial Appendage Filling Pattern by Using Intravenous Administration of Microbubbles: Comparison Between Mitral Stenosis and Mitral Regurgitation”, 2001) in view of Salgo et al. (US Pub No. 2018/0192987), as evidenced by Mejia (US Pub No. 2002/0016549) [claim 4].
With regards to claim 1, Ha et al. disclose a device for determining a pressure-related value of a mitral valve of a heart, the device comprising:
a processor in communication with memory (pg. 1101, Section “Echocardiography”, referring to use of the “Hewlett-Packard SONOS 5500” system which is a known ultrasound machine that includes a processor/memory to perform diagnostics; further referring to the calculations/determinations performed (i.e. such as ejection fraction determination) which inherently require a processor/computer), the processor configured to:
obtain a first ultrasound image of a heart comprising at least a proximal part of a left atrial appendage of the heart in a first state, wherein the proximal part of a left atrial appendage refers to the part close to the left atrium (pg. 1100, right column, “Introduction”, referring to the left atrial appendage (LAA) being a small, muscular extension of the left atrium arising near the left pulmonary veins; Abstract; pgs. 1101-1102, Section “Echocardiography”, referring to transthoracic echocardiography and TEE being performed, wherein multiplane TEE was performed with a 5-MHz, phased array transducer and further referring to LAA area being measured from the TEE examination, wherein LAA maximal area was measured and determined by the appearance of the p wave on the electrocardiogram, wherein the image associated with the measurement at the p wave point corresponds to the “first ultrasound image”; Figures 1-2, which depict echocardiographic/US images which include the left atrial appendage cavity);
obtain a second ultrasound image of a heart comprising at least the proximal part of the left atrial appendage of the heart in a second state (Abstract; pgs. 1101-1102, Section “Echocardiography”, referring to transthoracic echocardiography and TEE being performed, wherein multiplane TEE was performed with a 5-MHz, phased array transducer and further referring to LAA area being measured from the TEE examination, wherein LAA minimal area was measured around the appearance of the QRS complex, wherein the image associated with the measurement around the QRS complex corresponds to the “second ultrasound image”; Figures 1-2);
wherein the first state relates to a first pressure state of the left atrium of the heart (pg. 1101, right column, referring to the LAA maximal area being determined by the appearance of the p wave on the electrocardiogram, wherein, as is known in the art, the “p wave” represents atrial depolarization which initiates atrial contraction and is associated with a pressure state during a cardiac cycle, and thus the first state relates to a first pressure state of the left atrium of the heart during a cardiac cycle) and the second state relates to a second pressure state of the left atrium of the heart which second pressure state is different than the first pressure state (pg. 1101, right column, referring to the LAA minimal area being determined around the appearance of the QRS-complex, wherein, as is known in the art, the QRS complex represents the rapid depolarization of the right and left ventricles, corresponding to ventricular contraction (systole) and is associated with a pressure state during a cardiac cycle, and thus the second state relates to a second pressure state of the left atrium of the heart during a cardiac cycle, which is different from a pressure state (i.e. “first state”) of the P-wave);
to determine at least one first anatomical measurement (i.e. LAA maximal area) relating to the left atrial appendage (pg. 1101, right column, referring to determining the LAA maximal area);
determine at least one second anatomical measurement (i.e. LAA minimal area) relating to the left atrial appendage (pg. 1101, right column, referring to determining the LAA minimal area); and
to derive at least one relation (i.e. LAA ejection fra of the at least one first anatomical measurement and the at least one second anatomical measurement (pg. 1101, right column, referring to calculating the LAA ejection fraction, which is calculated as (LAA maximal area minus LAA minimal area) divided by LAA maximal area); and
wherein the derived at least one relation corresponds to an indicator for a pressure related parameter (i.e. mitral stenosis or mitral regurgitation) of the mitral valve (Abstract, pg. 1102, right column, “Results: Clinical and Echocardiographic Characteristics”, referring to patients with mitral stenosis (MS) or MR (mitral regurgitation) having reduced LAA ejection fraction, and thus LAA ejection fraction corresponds to an indicator for mitral stenosis or mitral regurgitation, which are associated with changes in pressure [as is known in the art; further see paragraphs [0002], [0011] of Applicant’s PG-Pub 2025/0017558 which notes that mitral regurgitation leads to a pressure increase/change and is further recognized as a “pressure related parameter” of the mitral valve] and thus corresponds to a “pressure related” parameter of the mitral valve; Table 2).
However, Ha et al. do not specifically disclose that the determination of the at least one first anatomical measurement is from a first segmentation of at least a part of the left atrial appendage generated by segmenting the first ultrasound image and the determination of the at least one second anatomical measurement is from a second segmentation of at least part of the left atrial appendage generated by segmenting the second ultrasound image.
Ha et al. further do not specifically disclose that the processor is further configured to “provide”/output the indicator for the pressure related parameter of the mitral valve.
Salgo et al. disclose ultrasound systems and methods for automatically determining heart chamber characteristics, wherein ultrasound images including at least one chamber of the heart are acquired and wherein the acquired images are used to segment the heart chamber (Abstract; paragraph [0021]; Figure 2). With the segmentation data, a boundary around the heart chamber can be determined and used to calculate dimensions in 2D or 3D depending on the image data being segmented (paragraph [0021]; Figure 2). Spatial characteristics, including area, can be determined based on the segmentation (paragraph [0021]). The spatial characteristic can be tracked over time and plotted as a waveform, wherein a static pressure can then be calculated based on the image data and/or the waveform (paragraph [0021]). The calculated static pressure in the heart chamber can then be displayed for consideration in order to be used for diagnosis (paragraphs [0021]-[0024], note that a result (i.e. static pressure) determined from the anatomical measurements is displayed/provided).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the determination of the at least one first anatomical measurement of Ha et al. be from a first segmentation of at least a part of the left atrial appendage generated by segmenting the first ultrasound image and the determination of the at least one second anatomical measurement of Ha et al. be from a second segmentation of at least part of the left atrial appendage generated by segmenting the second ultrasound image, as taught by Salgo et al., as Ha et al. requires obtaining an area measurement of the left atrial appendage and Salgo et al. teaches a known technique for obtaining an area measurement of a region of the heart. That is, using the known technique for obtaining an area measurement of a desired region of the heart, as desired by Ha et al., by segmenting the desired region of the heart in the ultrasound image, as taught by Salgo et al., would have been obvious to one of ordinary skill in the art.
Further, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the processor of Ha et al. “provide” the indicator for the pressure related parameter of the mitral valve, as taught by Salgo et al., in order to allow evaluation of the indicator for diagnostic purposes (paragraphs [0021]-[0024]).
With regards to claim 2, Ha et al. disclose that the at least one relation comprises a relative difference between the at least one first anatomical measurement and the at least one second anatomical measurement; and wherein the derived at least one relation is provided as an indicator for mitral regurgitation (pg. 1101, right column, referring to the LAA ejection fraction calculated by using a relative difference (i.e. LAA maximal area minus LAA minimal area) divided by LAA maximal area; Abstract, pg. 1102, right column, “Clinical and Echocardiographic Characteristics”, referring to patients with MS or MR (i.e. mitral regurgitation) having a reduced LAA ejection fraction compared with those of control patients, and therefore the ejection fraction serves as an indicator for mitral regurgitation).
With regards to claims 3-5, the limitations of claim 3 directed to “wherein the first pressure state and the second pressure state related to at lest one of: ii) a first point and a second point on one pressure curve of a cardiac cycle, wherein the second point is different from the first point; and ii) a pressure state at a first state of a cardiac treatment and a pressure state at a second stage of the cardiac treatment, the second stage being different in relation to the proceeding of the cardiac treatment than the first stage; wherein the first pressure state and the second pressure state relate to the same part of a respective cardiac cycle” and the limitations of claims 4 and 5 which further define the first/second points and the first/second stages as set forth in claim 3 are directed to an intended use and/or manner of operating the claimed device which, as set forth in claim 1, solely structurally comprises of a processor, wherein the processor obtains/receives a first ultrasound image and a second ultrasound image with the left atrial appendage of the heart in the respective images being in different pressure states. An imaging system for actually acquiring the images and controlled to acquire the images at the specific pressure states/points/stages is not positively recited as part of the claimed apparatus and therefore the limitations further defining the pressure states is directed to an intended use and/or manner of operating the claimed apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the processor of the above combined references is capable of obtaining/receiving images in first and second pressure states related to any different points over time (see pg. 1101, right column, referring to values being obtained over “5 consecutive cardiac cycles”, and thus the processor of Ha et al. is capable of obtaining/receiving images from any time point over 5 cardiac cycles, which would encompass the above claimed points/stages over time), including a first and second point and a first and second stage as set forth in claims 3-5, the above combined references meet the limitations. However, it is noted that Ha does disclose the limitations of claims 3 and 4. Specifically, with regards to claim 3, Ha et al. disclose that the first pressure state and the second pressure state relate to at least one of: i) a first point and a second point on one pressure curve of a cardiac cycle, wherein the second point is different from the first point; and ii) a pressure state at a first stage of a cardiac treatment and a pressure state at a second stage of the cardiac treatment, the second stage being different in relation to the proceeding of the cardiac treatment than the first stage; wherein the first pressure state and the second pressure state relate to the same part of a respective cardiac cycle (pg. 1101, right column, referring to the LAA maximal area being determined by the appearance of the p wave (i.e. first point on a pressure curve (i.e. ECG waveform, which is known to be representative of atrial pressure states during a cardiac cycle and thus corresponds to a “pressure curve”) and referring to the LAA minimal area being determined around the appearance of the QRS complex (i.e. second point different from the first point)). Further, with regards to claim 4, Ha et al. disclose that wherein, for i), the first pressure state relates to a first point on an atrial pressure curve and the second pressure state relates to a second point on the atrial pressure curve; wherein the first point is a first peak of an a-wave part of the atrial pressure curve and the second point is a second peak of a v-wave part of the atrial pressure curve (pg. 1101, right column, referring to the LAA maximal area being determined by the appearance of the p wave and the LAA minimal area being measured around the appearance of the QRS complex, wherein, as evidenced by Majia, p-wave of an ECG corresponds to the A wave of an atrial pressure waveform and “around” the QRS complex of an ECG corresponds to a V wave (see paragraphs [0005], [0021] of Majia) and wherein the at least one relation of the at least one first anatomical measurement and the at least one second anatomical measurement comprises a determination of a relative difference between the first and the second peak in relation to an amplitude of the atrial pressure curve (pg. 1101, right column, referring to the LAA ejection fraction calculated by using a relative difference (i.e. LAA maximal area minus LAA minimal area) divided by LAA maximal area; Abstract, pg. 1102, right column, “Clinical and Echocardiographic Characteristics”, referring to patients with MS or MR (i.e. mitral regurgitation) having a reduced LAA ejection fraction compared with those of control patients, and therefore the ejection fraction serves as an indicator for mitral regurgitation, wherein, as evidenced by Majia, the LAA maximal area and LAA minimal area respectively correspond to first and second peaks of an amplitude of the atrial pressure curve (see paragraphs [0005] and [0021] of Mejia et al. and Figures 2-3 of Mejia et al.).
With regards to claim 6, Ha et al. disclose that the processor is configured to obtain an electrocardiogram in order to determine the first point and the second point on the atrial pressure curve (pg. 1101, right column, referring to the LAA maximal area and LAA minimal area being determined by the appearance of specific points (i.e. P-wave, QRS complex) of an electrocardiogram).
With regards to claim 7, Ha et al. disclose that the first ultrasound image and the second ultrasound image further comprise a mitral valve area of the heart (see Figure 2, wherein mitral regurgitation and mitral stenosis are depicted, which would require that the mitral valve area be imaged). With regards to the limitation directed to the first and second ultrasound images being “i) provided by a mitral valve procedure and are used for the determining of the pressure-related value of a mitral valve of a heart and/or ii) provided for a mitral valve procedure”, the limitations are directed to an intended use and/or manner of operating the claimed device/apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the processor of the claimed device is capable of obtaining the ultrasound images provided by/for any cardiac procedure, including a mitral valve procedure, Ha et al. meets the limitations.
With regards to claim 10, Salgo et al. disclose that the device further comprises a display (38) configured to display the derived at least one relation (paragraphs [0021]-[0024], referring to the calculated static pressure in the heart chamber can then be displayed on a display for consideration in order to be used for diagnosis; Figure 1).
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ha et al. in view of Salgo et al. as applied to claim 1 above, and further in view of Camus et al. (US Pub No. 2019/0090951).
With regards to claim 8, as discussed above, the above combined references meet the limitations claim 1. However, they do not specifically disclose that the processor is configured to provide the segmenting as at least one of model-based segmentation, deep-learning segmentation and manual segmentation based on user input via a user interface.
Camus et al. disclose acquiring 3D datasets of the left atrial appendage (LAA) with 3D TEE or volume ICE, wherein the LAA is detected and segmented from the 3D datasets (Abstract; paragraph [0018]). Boundary detection for the segmentation can be accomplished using an anatomical model (e.g. template) fit to the ultrasound dataset or a machine-learnt classifier detects the LAA (paragraph [0030]). A user may further refine the segmentation result in order to avoid potential segmentation errors (paragraph [0042]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the processor of the above combined references be further configured to provide the segmenting as at least one of model-based segmentation, deep-learning segmentation and manual segmentation based on user input via a user interface, as taught by Camus et al., in order to avoid potential segmentation errors, thereby providing a more accurate segmentation of the left atrial appendage (paragraph [0042]).
With regards to claim 9, as discussed above, the above combined references meet the limitations of claim 1. Further, Ha et al. disclose that a mitral valve image is obtained (see Figure 2, wherein mitral regurgitation and mitral stenosis are depicted, which would require that the mitral valve area be imaged) and Salgo et al. disclose that the image (i.e. mitral valve image in the above combined references) is segmented (paragraph [0021]; note that the above combined references thus discloses that the processor is configured to segment a mitral valve image).
However, the above combined references do not specifically disclose that the processor is further configured to register the segmentation with a model and estimate a location of the left atrial appendage in the mitral valve image based on a left atrial appendage location indication of the model.
Camus et al. disclose acquiring 3D datasets of the left atrial appendage (LAA) with 3D TEE or volume ICE, wherein the LAA is detected and segmented from the 3D datasets (Abstract; paragraph [0018]). Boundary detection for the segmentation can be accomplished using an anatomical model (e.g. template) fit/registered to the ultrasound dataset or a machine-learnt classifier detects the LAA (paragraph [0030]). A user may further refine the segmentation result in order to avoid potential segmentation errors (paragraph [0042], note that the user thus performs a segmentation in the image via the refinement of the segmentation result, wherein the result of the refinement (i.e. segmentation) is registered/correlated/fit with the anatomical model). To avoid tracing an image for each phase of the heart cycle, the outline of the LAA is found in an image for one phase and then tracked through the datasets for the other phases (paragraph [0042], note that this can also be viewed as estimating a location of the LAA in the image (i.e. at a later phase) based on a LAA location indication (i.e. outline) of the LAA model).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the processor of the above combined references be further configured to register the segmentation with a model and estimate a location of the left atrial appendage in the mitral valve image based on a left atrial appendage location indication of the model, as taught by Camus et al., in order to avoid the tracing/segmentation of an image for each phase of the heart cycle (paragraph [0042]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang et al. (US Patent No. 10,881,461) discloses a method for analyzing hollow anatomical structures of interest for percutaneous implantation, wherein left atrial appendage measurements may include one or more of maximal and minimal diameter of the left atrium, the measurements of the ostium of the left atrial appendage (e.g., at least one of a maximal diameter, a minimal diameter, an area, or a circumference, etc.) (Abstract; column 7, lines 14-26).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798