DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, in line 15, --- the --- should be inserted before “at least”.
In claim 1, in line 17, --- the --- should be inserted before “at least proximal part…”.
In claim 1, in line 19, “a pressure related” should be replaced with --- the pressure-related ---.
Appropriate correction is required.
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 the 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 fraction) 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 value (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 of the first image or the segmenting of the second image 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 of the first image or the segmenting of the second image 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 of the mitral valve image 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 of the mitral valve image 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]).
Response to Arguments
With regards to the 35 USC 101 rejection, Applicant’s arguments, see pg. 9, 2nd paragraph-pg.10, filed July 2, 2026, with respect to the 35 USC 101 rejection have been fully considered and are persuasive. The 35 USC 101 rejection of claims 1-10 has been withdrawn.
With regards to the prior art rejections, Applicant's arguments filed July 2, 2026 have been fully considered but they are not persuasive.
With regards to Ha, Applicant argues that Ha is not using LAA geometry as a pressure surrogate for determining a mitral-valve pressure-related value nor does Ha provide a teaching of any method of diagnosis or analysis of LAA shape change to indicate a pressure-related value of the mitral valve. Ha therefore does not provide the LAA measurement relation as an indicator for pressure-related value of the mitral valve as required by claim 1.
Examiner respectfully disagrees and notes that the claim recites “provide the derived at least one relation as an indicator for a pressure-related value of the mitral valve”, which under broadest reasonable interpretation (BRI) has been interpreted to mean that the processor outputs/displays/”provides” the derived at least one relation, the derived at least relation serving “as an indicator” for a pressure-related value of the mitral valve. Examiner notes that claim 1 is directed to a device/apparatus, wherein the limitation “provide the derived at least one relation…” structurally requires that the processor outputs/displays the derived at least one relation, but the limitation clarifying that the at least one relation is provided “as an indicator for a pressure-related value of the mitral valve” appears to not be further structurally limiting the processor, but rather providing a description of what the outputted/displayed/provided “derived at least one relation” can provide an indication of. In other words, the limitation describing the claimed at least one relation “as an indicator for a pressure-related value of the mitral valve” is describing an intended use of the claimed apparatus as it appears to be describing what the derived at least one relation can indicate represent (i.e. to a user/operator) rather than describing a further structural limitation of 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 combination of Ha and Salgo does teach that the processor can provide/output/display the derived at least one relation, wherein the at least one relation (i.e. LAA ejection fraction) can or “is capable” of serving as an indicator for a pressure-related value (i.e. mitral stenosis or mitral regurgitation) (i.e. see Abstract; pg. 1102, right column “Results, Clinicial and Echocardiographic Characteristics” of Ha, wherein Ha recognizes that patients with mitral stenosis (MS) or mitral regurgitation (MR) have a reduced LAA ejection fraction, and thus it follows that the LAA ejection fraction has the inherent property of providing an indication of MS or MR (i.e. pressure-related value of the mitral valve)), the combination of Ha and Salgo meets the above limitation. Examiner emphasizes that the use of the derived at least one relation “as an indicator for a pressure-related value of the mitral valve” is interpreted as requiring that the processor outputs/displays/provides the derived at least one relation, wherein the derived at least one relation serves as “an indicator” as it can be information presented/provided/displayed to a user that the user can determine as providing an indication for the pressure-related value of the mitral valve.
With regards to Salgo, Applicant argues that Salgo does not teach the specific claim 1 sequence of obtaining “a first ultrasound image of a heart comprising at least a proximal part of a left atrial appendage” in a first pressure state, obtaining “a second ultrasound image” comprising that proximal LAA part in a different second pressure state, segmenting those images to generate first and second segmentations “of at least a part of the left atrial appendage, determining first and second “anatomical measurement[s] relating to the left atrial appendage, deriving a relation between those LAA measurements, and then providing the relation “as an indicator for a pressure related value of the mitral valve”.
However, Examiner notes that the above limitations are rejected under the combination of Ha and Salgo, wherein Ha is relied upon for teaching the obtaining of the first and second ultrasound images comprising of the proximal LAA part, determining the first and second anatomical measurements relating to the left atrial appendage and deriving a relation between those LAA measurements which correspond to an indicator for a pressure related value of the mitral valve, etc.. Ha does not specifically disclose that the determinations of the at least one first anatomical measurement is from the claimed first segmentation, that the at least one second anatomical measurements is from the claimed second segmentation and that the processor “provides” (i.e. displays/outputs) the indicator for the pressure related parameter of the mitral valve. Salgo teaches the segmentation and “provide” step (see above rejection), and is used to modify Ha to meet the above limitations. It is therefore the combination of Ha and Salgo that meets the above limitations.
The claims therefore remain rejected under the previously applied prior art.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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