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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/28/2025, 05/23/2025, and 07/16/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claims recite “applying a correlation algorithm to determine a value of cardiac pressure.” In regards to Step 2B - Prong 1, the applicant has limited the claims such that a processor acquires ultrasound data and does some kind of analysis with a correlation algorithm that is not further defined. As this can be done in the mind of a human or using pen and paper. This judicial exception is not integrated into a practical application because instructions to perform this process on a processor does not add significantly more to claim itself to overcome this rejection. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the data gathering steps required to use the correlation algorithm do not add a meaningful limitation as they are insignificant extra-solution activity.
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 (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8-10, 13, 14 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salgo et al. (Pub. No. US 2018/0192987).
Consider claims 1, 10, Salgo discloses an ultrasound imaging system (paragraph [0012], Fig. 1, ultrasound imaging system 10) comprising:
a processor configured (paragraph [0014], Fig. 1, segmentation processor 42) to:
receive ultrasound data from a heart, wherein the ultrasound data was acquired across at least a portion of a cardiac cycle (paragraph [0021], Fig. 2, acquiring an ultrasound image including the heart chamber (Step 56)); and
analyze the ultrasound data by applying a correlation algorithm to determine a value of cardiac pressure (paragraph [0021], based on the image data and/or waveform generated by the ultrasound system, a static pressure (e.g., of the left ventricle) can be calculated using optimal pressure calculation algorithms, see paragraph [0025]).
Consider claims 8, 13, Salgo discloses a strain processor configured to generate strain measurements based, at least in part on ultrasound signals received from the heart, wherein the strain measurements are included in the ultrasound data (paragraph [0021], strain information of the heart tissue can also be acquired and tracked).
Consider claims 9, 14, Salgo discloses wherein the processor is further configured to generate a classifier associated with the value of the cardiac pressure (paragraph [0017], a value can compare to the statistical data to identify whether congestive heart failure is likely).
Consider claim 19, Salgo discloses where the ultrasound data is from at least one of a left atrium or a left ventricle of the heart (paragraph [0022], Fig. 3, left atrium).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Salgo in view of Hunziker et al. (Pub. No.: US 2014/0276071).
Consider claims 2, 16, Salgo does not specifically disclose wherein the correlation algorithm comprises at least one of a partial least squares model or a long short-term memory network.
Hunziker discloses wherein the correlation algorithm comprises at least one of a partial least squares model or a long short-term memory network (paragraph [0076], Fig. 2, step 210, a least-square optimal fashion).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace the optimal pressure calculation algorithms as disclosed by Salgo with the least-square optimal fashion as taught by Hunziker to determine a mathematical model that transforms the physiologic input data into the target cardiac output (Hunziker, paragraph [0076]).
Consider claim 18, Salgo does not specifically disclose wherein the analyzing comprises applying a transfer function including at least one regression coefficient to the ultrasound data.
Hunziker discloses wherein the analyzing comprises applying a transfer function including at least one regression coefficient to the ultrasound data (paragraph [0075], multitude of CO measurement samples taken for each subject is examined using e.g., regression to the mean).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace processor as disclosed by Salgo with the processor as taught by Hunziker to identify an average value (Hunziker, paragraph [0075]).
Claims 3, 4, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Salgo in view of Konofagou et al. (Pub. No.: US 2016/0249880).
Consider claims 3, 11, Salgo does not specifically disclose wherein the processor is further configured to interpolate the ultrasound data to a pre-set number of frames across the at least the portion of the cardiac cycle.
Konofagou discloses wherein the processor is further configured to interpolate the ultrasound data to a pre-set number of frames across the at least the portion of the cardiac cycle (paragraph [0061], a set of N frames of raw ultrasound data of the heart is acquired during a cardiac cycle).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace processor as disclosed by Salgo with the processor as taught by Konofagou to be useful for imaging the propagation of electromechanical waves in the heart (Konofagou, paragraph [0061]).
Consider claim 4, Salgo does not specifically disclose wherein the processor is further configured to filter the ultrasound data with a digital filter.
Konofagou discloses wherein the processor is further configured to filter the ultrasound data with a digital filter (paragraph [0086], slow motions of the tissues were separated using a digital filter).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace processor as disclosed by Salgo with the processor as taught by Konofagou in order to separate slow motions of the tissues (Konofagou, paragraph [0086]).
Consider claim 20. Salgo discloses a non-transitory computer-readable medium containing instructions (paragraph [0030], a tangible and non-transitory computer readable medium), that when executed, causes an imaging system to:
receive ultrasound data from a heart, wherein the ultrasound data was acquired across at least a portion of a cardiac cycle (paragraph [0021], Fig. 2, acquiring an ultrasound image including the heart chamber (Step 56)); and
analyze the ultrasound data by applying a correlation algorithm to determine a value of cardiac pressure (paragraph [0021], based on the image data and/or waveform generated by the ultrasound system, a static pressure (e.g., of the left ventricle) can be calculated using optimal pressure calculation algorithms, see paragraph [0025]).
Salgo does not specifically disclose interpolate the ultrasound data to a pre-set number of frames over the cardiac cycle (paragraph [0061], a set of N frames of raw ultrasound data of the heart is acquired during a cardiac cycle); and filter the ultrasound data with a digital filter after interpolating.
Konofagou discloses interpolate the ultrasound data to a pre-set number of frames over the cardiac cycle; and filter the ultrasound data with a digital filter after interpolating (paragraph [0086], slow motions of the tissues were separated using a digital filter).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace processor as disclosed by Salgo with the processor as taught by Konofagou in order to separate slow motions of the tissues (Konofagou, paragraph [0086]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Salgo and Konofagou in view of Olivier (Pub. No.: US 2014/0128691).
Consider claim 5, the combination of Salgo and Konofagou does not specifically disclose wherein the digital filter includes a Savitsky-Golay filter with a cubic polyfit.
Olivier discloses wherein the digital filter includes a Savitsky-Golay filter with a cubic polyfit (paragraph [0050], Savitsky-Golay filter).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace the digital filter as disclosed by the combination of Salgo and Konofagou with the Savitsky-Golay filter as taught by Olivier in order to increase the signal-to-noise (S/N) ratio (Olivier, paragraph [0050]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Salgo in view of Haslam et al. (Pub. No: US 2021/0335041).
Consider claims 6, 7, Salgo does not specifically disclose wherein the processor is further configured to: analyze a sequence of two-dimensional ultrasound images with a machine learning model to determine a border of a chamber of the heart in individual ones of the two-dimensional ultrasound images; and
calculate volumes of the chamber, based, at least in part, on the borders of the individual ones of the two-dimensional ultrasound images, wherein the volumes of the chamber are included in the ultrasound data.
Haslam discloses wherein the processor is further configured to: analyze a sequence of two-dimensional ultrasound images with a machine learning model to determine a border of a chamber of the heart in individual ones of the two-dimensional ultrasound images (paragraph [0193], predetermined orientation and spacing between each 2D medical image (associated with chamber of the heart, see paragraph [0212]) within the new set of 2D medical images are determined using machine learning wherein each channel represents a 2D image corresponding to a slice position within the 3D space of the 3D image, see paragraph [0202]); and
calculate volumes of the chamber, based, at least in part, on the borders of the individual ones of the two-dimensional ultrasound images, wherein the volumes of the chamber are included in the ultrasound data (paragraphs [0211] to [0212], determined from the generated 3D image are volume of the heart, volume of blood in each chamber of the heart, thickness of the different layers of the heart wall).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace the processor as disclosed by Salgo with the processor as disclosed by Haslam to determine from the generated 3D image, parameters of the patient anatomic feature (Haslam, paragraph [0211]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Salgo in view of Olivier (Pub. No.: US 2014/0128691).
Consider claim 12, Salgo discloses filtering the ultrasound data with a digital filter prior to the analyzing (paragraph [0013], signal processor 26 can process the received echo signals by bandpass filtering).
Salgo does not specifically disclose wherein the digital filter comprises a Savitsky-Golay filter with a cubic polyfit.
Olivier discloses wherein the digital filter comprises a Savitsky-Golay filter with a cubic polyfit (paragraph [0050], Savitsky-Golay filter).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace the digital filter as disclosed by Salgo and with the Savitsky-Golay filter as taught by Olivier in order to increase the signal-to-noise (S/N) ratio (Olivier, paragraph [0050]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Salgo in view of Shuros et al. (Pub. No.: US 2010/0100144).
Consider claim 15, Salgo does not specifically disclose wherein the classifier is a binary classifier and the binary classifier has a first level when the value of the pressure is below a threshold value and a second level when the value of the cardiac pressure is equal to or above the threshold value.
Shuros discloses wherein the classifier is a binary classifier and the binary classifier has a first level when the value of the pressure is below a threshold value and a second level when the value of the cardiac pressure is equal to or above the threshold value (paragraph [0068], claim 3, comparing the hemodynamic measurement with respective thresholds to determine if it exceeds or falls below the threshold).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace the processor as disclosed by Salgo with the processor as taught by Shuros to avoid inappropriate therapy, such as defibrillation shocking (Shuros, paragraph [0068]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Salgo and Hunziker in view of Hope et al. (Pub. No.: WO 2018/127497).
Consider claim 17, the combination of Salgo and Hunziker does not specifically disclose training the model with a training data set, wherein the training data set comprises an ultrasound dataset labeled with a value of the cardiac pressure acquired from a catheter.
Hope discloses training the model with a training data set, wherein the training data set comprises an ultrasound dataset labeled with a value of the cardiac pressure acquired from a catheter (paragraph [037], neural network may be trained to identify and localize flowing flood from the 2D echo image data when the neural network operates on echoes acquired from an array supported on an intravascular ultrasound (IVUS)imaging catheter associated with a cardiac chamber, see paragraph [050]).
Therefore, it would have been obvious one having ordinary skill in the art before the effective filing date of the claimed invention to replace model as disclosed by the combination of Salgo and Hunziker with the model as taught by Hope to distinguish different tissue types on the basis of the spatial and temporal characteristics of the echoes from multiple transmit events (Hope, paragraph [037]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 10, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 18 of U.S. Patent No. 12,239,479. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application contain each and every element of the patent.
Instant Application
U.S. Patent No. 12,239,479
1. An ultrasound imaging system comprising: a processor configured to: receive ultrasound data from a heart, wherein the ultrasound data was acquired across at least a portion of a cardiac cycle; and analyze the ultrasound data by applying a correlation algorithm to determine a value of cardiac pressure.
1. An ultrasound imaging system comprising: a processor configured to: receive ultrasound data from a heart, wherein the ultrasound data was acquired across at least a portion of a cardiac cycle; and analyze the ultrasound data by applying a correlation algorithm to determine a value of cardiac pressure, wherein the correlation algorithm comprises at least one of a partial least squares model or a long short-term memory network.
10. A method comprising: receiving ultrasound data from a heart, wherein the ultrasound data was acquired across a cardiac cycle; and analyzing the ultrasound data by applying a correlation algorithm to determine a value of cardiac pressure.
9. A method comprising: receiving ultrasound data from a heart, wherein the ultrasound data was acquired across a cardiac cycle; and analyzing the ultrasound data by applying a correlation algorithm to determine a value of cardiac pressure, wherein the correlation algorithm includes a model, wherein the model includes at least one of a partial least squares model or a long short-term memory network.
20. A non-transitory computer-readable medium containing instructions, that when executed, causes an imaging system to: receive ultrasound data from a heart, wherein the ultrasound data was acquired across at least a portion of a cardiac cycle; interpolate the ultrasound data to a pre-set number of frames over the cardiac cycle; filter the ultrasound data with a digital filter after interpolating; and analyze the ultrasound data by applying a correlation algorithm to determine a value of cardiac pressure after filtering.
18. A non-transitory computer-readable medium containing instructions, that when executed, causes an imaging system to: receive ultrasound data from a heart, wherein the ultrasound data was acquired across at least a portion of a cardiac cycle; interpolate the ultrasound data to a pre-set number of frames over the cardiac cycle; filter the ultrasound data with a digital filter after interpolating; and analyze the ultrasound data by applying a correlation algorithm to determine a value of cardiac pressure after filtering, wherein the correlation algorithm comprises at least one of a partial least squares model or a long short-term memory network.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 3-9, 11-15, and 17-19 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 2-8, 10-14, and 15-17 of prior U.S. Patent No. 12,239,479. This is a statutory double patenting rejection.
Conclusion
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/Gerald Johnson/
Primary Examiner, Art Unit 3797