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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/02/2026 has been entered.
Response to Arguments
Priority
Applicant's arguments filed 1/2/2026 regarding the rejection of claim 11 under 35 U.S.C. 112(a) have been fully considered but they are not persuasive. Applicant argues that U.S. Application No. 12/536,247 (the ‘247 App) provides support for the limitation “[o]ne or more tangible non-transitory computer-readable storage media storing computer-executable instructions for performing a computer process on a computing system” as recited in amended claim 11, lines 1-3, filed 1/2/2026.
First, Applicant cites paragraph [0065] “[r]eferring still to FIG. 11, a controller 102 is shown. The controller can include a computer adapted to connect and control several interfaces.” This disclosure does not establish that the computer/controller comprises ““[o]ne or more tangible non-transitory computer-readable storage media storing computer-executable instructions for performing a computer process on a computing system” as recited in claim 11, lines 1-3. At most, paragraph [0065] discloses a computing system. No storage media or instructions are disclosed.
Second, Applicant cites paragraph [0072]. As stated in the Final Rejection mailed 07/01/2026 at 3:
Applicant further argues that App. No. 12/536,247’s (the ‘247 app) disclosure of “the memory of the controller 102 may be a digital memory of a hard drive where a computer system is provided as the controller 102. Other memory types can be used” discloses the alleged claim feature of “[o]ne or more tangible non-transitory computer-readable storage media storing computer-executable instructions for performing a computer process on a computing system” as recited in claim 11. Remarks, P.5-6.
The applicant does not provide evidence that the “digital memory of a hard drive” disclosed in the ‘247 app stores computer-executable instructions for performing a computer process on a computing system. Paragraph [0072] provides that “[a]fter imaging and acquisition, all ultrasound-generated data may be recorded and stored in a memory of the controller 102” and “where a computer system is provided as the controller 102.” There is no disclosure that the memory stores computer-executable instructions for performing a computer process.
Additionally, there is no disclosure that the memory contains instructions that perform the process of claim 11, lines 4-12.
Therefore, applicant’s argument is unpersuasive.
At most, paragraph [0072] provides that the controller comprises a non-transitory computer-readable storage media memory for storing ultrasound data. However, this does not disclose storing computer-executable instructions for performing a computer process on a computing system, particularly, the process recited in claim 11, lines 4-13.
As Applicant has not demonstrated that the ‘247 App discloses the subject matter of claim 11, lines 1-3, Applicant’s arguments are not persuasive.
Furthermore, Applicant does not provide arguments addressing the deficient claim for benefit with regard to the remaining applications for claim 11. Therefore, these findings are maintained.
Additionally, Applicant’s amendments to claims 6 and 16 as filed 1/2/2026 have obviated the rejections of claims 6 and 16 under 35 U.S.C. 112(a). The rejections of claims 6 and 16 are withdrawn.
102 and 103 Rejections
Applicant’s arguments with respect to claim(s) 1-7, 10-17, and 20-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. As detailed in infra rejections: Claims 1-4, 6-7, 10, and 22 are rejected over Yang in further view of Murphy; Claim 5 is rejected over Yang in further view of Murphy in further view of Specht; Claim 21 is rejected over Yang in further view of Murphy in further view of Baba; Claims 11-12, 14-17, 20, and 24 are rejected over Yang in further view of Murphy; Claim 13 is rejected over Yang in further view of Murphy in further view of Specht; and Claim 23 is rejected over Yang in further view of Murphy in further view of Baba.
Double Patenting
As detailed in infra rejections claims 1-7, 10-17, and 20-24 are rejected over claim 7 of U.S. Patent No. 8,348,847, or over claim 7 of U.S. Patent No. 8,348,847 in further view of Specht, Murphy, Yang, or Baba.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/086,254 and 61/224,621 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, these applications provide no disclosure as to “automatically controlling an adjustment of the probe” as recited in claims 1 and 11.
The disclosure of the prior-filed application, Application No. 61/086,254, 61/140,767, 61/224,621, and 12/536,247 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, these applications provide no disclosure as to “[o]ne or more tangible non-transitory computer-readable storage media storing computer-executable instructions for performing a computer process on a computing system” as recited in claim 11, lines 1-3.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5, line 2 recites “a transthoracic parasternal window, a transthoracic a sub-costal window, or a suprasternal notch window.” This should read “a transthoracic parasternal window, a transthoracic window, a sub-costal window, or a suprasternal notch window.”
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-7, 10, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (U.S. Pub. No. 2008/0249414), hereinafter “Yang,” in further view of Murphy et al. (U.S. Pub. No. 2003/0187362), hereinafter “Murphy.”
Regarding claim 1, Yang discloses a method for managing a patient (method of determining change in left ventricle volume of the heart of a patient, Abstract, [0093]) comprising:
obtaining first data corresponding to the patient (obtain one or more 2D scan planes, [0127]; six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351]), the first data captured at a window using a probe (place ultrasound transceiver to capture apical view, [0118], [0242], [0247]);
generating at least one image along an imaging cross-section of the window using the first data corresponding to the patient (generate an image of the one or more 2D scan planes, [0115], [0127]);
automatically controlling an adjustment of the probe (automatically rotate transducer angle using a motor to acquire one or more 2D scan planes, [0127]);
obtaining second data corresponding to the patient (obtain a plurality of 2D scan planes, [0127]; six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351]), the second data captured using the probe following the adjustment of the probe (one or more subsequent 2D scan planes are acquired following rotation of the transducer, [0127]);
determining a cardiovascular function status of the patient based on at least one of the first data or the second data (six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351], 3D transthoracic echocardiogram allows hemodynamic calculations by trained level-set algorithms, [0349], hemodynamic calculations by the trained level-set algorithms includes ejection fraction and cardiac output, [0356]-[0359]).
However, while Yang discloses that determining a cardiovascular function status of the patient such as measurements of contractility of cardiac muscle fibers via ejection fraction can be used to determine appropriate prescription of heart drugs such as ACE inhibitors or beta-blockers ([0004]) and that the ejection fraction is determined using one or more of the acquired 2D scan planes of the 3D US dataset ([0349], [0351], [0356]), Yang does not appear to explictly disclose generating an intervening measure based on the cardiovascular function status.
However, in the same field of endeavor of echocardiography, Murphy teaches generating an intervening measure based on the cardiovascular function status (images from echocardiography, [0099]; select intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the heart images to a database of images/models of healthy/normal hearts, [0014]-[0017]; [0034]-[0037], [0153], [0164], [0167], [0179]-[0184], [0193], [0201], [0206]-[0215]; see also various physiological and hemodynamic states, [0020]-[0032], [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Murphy’s known technique of selecting an intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the echocardiography images to a database of images of healthy/normal hearts to Yang’s known process of determining the physiological and hemodynamic state of a patient’s heart in echocardiography images to achieve the predictable result that using echocardiographic assessment of the heart and comparison to a database of healthy/normal heart images allows the selection of “an appropriate treatment to restore the cardiac system to its optimal or best acceptable condition” Murphy, [0089].
Regarding claim 2, Yang discloses at least one of the first data or the second data includes ultrasound-generated data points (transceiver acquires ultrasound signals, [0114]-[0115]).
Regarding claim 3, Yang discloses the cardiovascular function status of the patient is determined based on at least one of a cardiac output status, a filling pressure status, or a systolic blood pressure status (six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351], 3D transthoracic echocardiogram allows hemodynamic calculations by trained level-set algorithms, [0349], hemodynamic calculations by the trained level-set algorithms includes ejection fraction and cardiac output, [0356]-[0359]).
Regarding claim 4, Yang discloses the at least one image is a 2D image (generate an image of the one or more 2D scan planes, [0115], [0127]).
Regarding claim 6, Yang discloses determining the cardiovascular function status (six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351], 3D transthoracic echocardiogram allows hemodynamic calculations by trained level-set algorithms, [0349], hemodynamic calculations by the trained level-set algorithms includes ejection fraction and cardiac output, [0356]-[0359]).
However, Yang does not appear to disclose determining the cardiovascular function status based on a comparison of the at least one image to a set of one or more images having a categorization.
However, in the same field of endeavor of echocardiography, Murphy teaches determining the cardiovascular function status based on a comparison of the at least one image to a set of one or more images having a categorization (images from echocardiography, [0099]; select intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the heart images to a database of images/models of healthy/normal hearts, [0014]-[0017]; [0034]-[0037], [0153], [0164], [0167], [0179]-[0184], [0193], [0201], [0206]-[0215]; see also various physiological and hemodynamic states, [0020]-[0032], [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Murphy’s known technique of selecting an intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the echocardiography images to a database of images of healthy/normal hearts to Yang’s known process of determining the physiological and hemodynamic state of a patient’s heart in echocardiography images to achieve the predictable result that using echocardiographic assessment of the heart and comparison to a database of healthy/normal heart images allows the selection of “an appropriate treatment to restore the cardiac system to its optimal or best acceptable condition” Murphy, [0089].
Regarding claim 7, Yang discloses the adjustment of the probe includes adjusting a probe mode, wherein the probe mode includes at least one of a color Doppler image mode or a spectral Doppler image mode (ultrasound imaging and Doppler imaging modes, [0206], [0214], [0241]; continuous wave or pulse/parallel wave Doppler imaging, i.e., spectral Doppler imaging, [0231]-[0232]; see also US imaging mode in [0246] and Doppler imaging mode in [0231]-[0236]).
Regarding claim 10, Yang discloses the adjustment of the probe include adjusting at least one of a rotation angle or an elevation angle of the probe (one or more subsequent 2D scan planes are acquired following rotation of the transducer by a rotation angle, [0127]; one or more subsequent 2D scan planes are acquired following elevation tilt of the transducer by an elevation angle, [0224]).
Regarding claim 22, Yang does not appear to disclose the intervening measure includes an adjustment of a cardiovascular control determinant.
However, in the same field of endeavor of echocardiography, Murphy teaches the intervening measure includes an adjustment of a cardiovascular control determinant (selected intervention/treatment adjusts a cardiovascular control determinant, [0014]-[0017]; [0034]-[0037], [0153], [0164], [0167], [0179]-[0184], [0193], [0201], [0206]-[0215]; see also various physiological and hemodynamic states that may be adjusted, [0234]-[0269]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Murphy’s known technique of selecting an intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the echocardiography images to a database of images of healthy/normal hearts to Yang’s known process of determining the physiological and hemodynamic state of a patient’s heart in echocardiography images to achieve the predictable result that using echocardiographic assessment of the heart and comparison to a database of healthy/normal heart images allows the selection of “an appropriate treatment to restore the cardiac system to its optimal or best acceptable condition” Murphy, [0089].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in further view of Murphy as in claim 1 above, or, in the alternative, Yang in further view of Murphy in further view of Specht et al. (U.S. Pub. No. 2008/0103393), hereinafter “Specht.”
Regarding claim 5, Yang discloses the window includes at least one of: a transthoracic parasternal window, a transthoracic a sub-costal window, or a suprasternal notch window (place ultrasound transceiver to capture a transthoracic view, [0068], [0069], [0118], [0204], [0242], [0247], [0256], [0333], [0334], [0349], [0375]).
Additionally, or, in the alternative, Yang in further view of Murphy does not appear to disclose the window includes at least one of: a transthoracic parasternal window, a sub-costal window, or a suprasternal notch window.
However, in the same field of endeavor of echocardiography, Specht teaches the window includes at least one of: a transthoracic parasternal window, a sub-costal window, or a suprasternal notch window (ultrasound probe for echocardiography is placed at the transthoracic parasternal window or sub-costal window, [0069]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Specht’s known technique of placing an ultrasound probe at either the parasternal or subcostal window for transthoracic echocardiography to Yang in further view of Murphy’s known process employing an ultrasound echocardiography probe positioned at a transthoracic window to achieve the predictable result that for echocardiography the ultrasound probe may be positioned at the transthoracic parasternal window or the sub-costal window as available to achieve a clear view of the heart. See, e.g., Specht, [0069].
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in further view of Murphy as in claim 6 above, or, in the alternative, Yang in further view of Murphy in further view of Baba et al. (U.S. Patent No. 8,721,548).
Regarding claim 21, Yang does not appear to disclose the comparison is performed by a correlation algorithm based on one or more defined pattern correlations.
However, in the same field of endeavor of echocardiography, Murphy teaches the comparison is performed by a correlation algorithm based on one or more defined pattern correlations (images from echocardiography, [0099]; select intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the heart images to a database of images/models of healthy/normal hearts, [0014]-[0017]; [0034]-[0037], [0153], [0164], [0167], [0179]-[0184], [0193], [0201], [0206]-[0215]; see also various physiological and hemodynamic states, [0020]-[0032], [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Murphy’s known technique of selecting an intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the echocardiography images to a database of images of healthy/normal hearts to Yang’s known process of determining the physiological and hemodynamic state of a patient’s heart in echocardiography images to achieve the predictable result that using echocardiographic assessment of the heart and comparison to a database of healthy/normal heart images allows the selection of “an appropriate treatment to restore the cardiac system to its optimal or best acceptable condition” Murphy, [0089].
Additionally, or, in the alternative, Yang in further view of Murphy may not explictly disclose that the comparison is performed by a correlation algorithm based on one or more defined pattern correlations.
However, in the same field of endeavor of echocardiography, Baba teaches the comparison is performed by a correlation algorithm based on one or more defined pattern correlations (measurement items for various cardiac diseases are determined for the patient echocardiography image by comparison between a database of echocardiography images of able-bodied and disable-bodied persons categorized by each of the measurement items for the various cardiac diseases and the patient echocardiography image using a correlation algorithm, Col. 2, line 42 – Col. 6, line 43; see also Col.6, line 44 - Col. 10, line 48).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Baba’s known technique of applying a correlation analysis of similarity between the patient echocardiography images and a categorized database of able- and disable-bodied echocardiography images to determine a measurement item for various cardiac diseases for the patient to Yang in further view of Murphy’s known process of determining the physiological and hemodynamic state of the patient’s heart using a comparison to a database of healthy/normal heart images to achieve the predictable result that correlation/similarity analysis improves diagnosis efficiency by allowing for easy, quick, and accurate determination of whether a patient has a cardiac disease. See, e.g., Baba, Col. 9, line 56 – Col. 10, line 14.
Claims 11-12, 14-17, 20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in further view of Murphy.
Regarding claim 11, Yang discloses one or more tangible non-transitory computer-readable storage media storing computer-executable instructions for performing a computer process on a computing system (computer/microprocessor and memory for executing operating instructions, [0115], [0120], [0122]-[0124], [0128], Claims 4 and 7-9), the computer process comprising:
obtaining first data corresponding to a patient (obtain one or more 2D scan planes, [0127]; six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351]), the first data captured at a window using a probe (place ultrasound transceiver to capture apical view, [0118], [0242], [0247]);
generating at least one image along an imaging cross-section of the window using the first data corresponding to the patient (generate an image of the one or more 2D scan planes, [0115], [0127]);
automatically controlling an adjustment of the probe (automatically rotate transducer angle using a motor to acquire one or more 2D scan planes, [0127]);
obtaining second data corresponding to the patient (obtain a plurality of 2D scan planes, [0127]; six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351]), the second data captured using the probe following the adjustment of the probe (one or more subsequent 2D scan planes are acquired following rotation of the transducer, [0127]);
determining a cardiovascular function status of the patient based on at least one of the first data or the second data (six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351], 3D transthoracic echocardiogram allows hemodynamic calculations by trained level-set algorithms, [0349], hemodynamic calculations by the trained level-set algorithms includes ejection fraction and cardiac output, [0356]-[0359]).
However, while Yang discloses that determining a cardiovascular function status of the patient such as measurements of contractility of cardiac muscle fibers via ejection fraction can be used to determine appropriate prescription of heart drugs such as ACE inhibitors or beta-blockers ([0004]) and that the ejection fraction is determined using one or more of the acquired 2D scan planes of the 3D US dataset ([0349], [0351], [0356]), Yang does not appear to explictly disclose generating an intervening measure based on the cardiovascular function status.
However, in the same field of endeavor of echocardiography, Murphy teaches generating an intervening measure based on the cardiovascular function status (images from echocardiography, [0099]; automatically select intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the heart images to a database of images/models of healthy/normal hearts, [0014]-[0017]; [0034]-[0037], [0153], [0164], [0167], [0179]-[0184], [0193], [0201], [0206]-[0215]; see also various physiological and hemodynamic states, [0020]-[0032], [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Murphy’s known technique of selecting an intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the echocardiography images to a database of images of healthy/normal hearts to Yang’s known apparatus that determines the physiological and hemodynamic state of a patient’s heart in echocardiography images to achieve the predictable result that using echocardiographic assessment of the heart and comparison to a database of healthy/normal heart images allows the selection of “an appropriate treatment to restore the cardiac system to its optimal or best acceptable condition” Murphy, [0089].
Regarding claim 12, Yang discloses at least one of the first data or the second data includes ultrasound-generated data points (transceiver acquires ultrasound signals, [0114]-[0115]).
Regarding claim 14, Yang discloses the cardiovascular function status of the patient is determined based on at least one of a cardiac output status, a filling pressure status, or a systolic blood pressure status (six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351], 3D transthoracic echocardiogram allows hemodynamic calculations by trained level-set algorithms, [0349], hemodynamic calculations by the trained level-set algorithms includes cardiac output, [0357]-[0359]).
Regarding claim 15, Yang discloses the at least one image is a 2D image (generate an image of the one or more 2D scan planes, [0115], [0127]).
Regarding claim 16, Yang discloses determining the cardiovascular function status (six 2D scan planes at systole and diastole of the left ventricle used to automatically provide a 3D rendering of systole and/or diastole measurements, [0351], 3D transthoracic echocardiogram allows hemodynamic calculations by trained level-set algorithms, [0349], hemodynamic calculations by the trained level-set algorithms includes ejection fraction and cardiac output, [0356]-[0359]).
However, Yang does not appear to disclose determining the cardiovascular function status based on a comparison of the at least one image to a set of one or more images having a categorization.
However, in the same field of endeavor of echocardiography, Murphy teaches determining the cardiovascular function status based on a comparison of the at least one image to a set of one or more images having a categorization (images from echocardiography, [0099]; automatically select intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the heart images to a database of images/models of healthy/normal hearts, [0014]-[0017]; [0034]-[0037], [0153], [0164], [0167], [0179]-[0184], [0193], [0201], [0206]-[0215]; see also various physiological and hemodynamic states, [0020]-[0032], [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Murphy’s known technique of selecting an intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the echocardiography images to a database of images of healthy/normal hearts to Yang’s known apparatus that determines the physiological and hemodynamic state of a patient’s heart in echocardiography images to achieve the predictable result that using echocardiographic assessment of the heart and comparison to a database of healthy/normal heart images allows the selection of “an appropriate treatment to restore the cardiac system to its optimal or best acceptable condition” Murphy, [0089].
Regarding claim 17, Yang discloses the adjustment of the probe includes adjusting a probe mode, wherein the probe mode includes at least one of a color Doppler image mode or a spectral Doppler image mode (ultrasound imaging and Doppler imaging modes, [0206], [0214], [0241]; continuous wave or pulse/parallel wave Doppler imaging, i.e., spectral Doppler imaging, [0231]-[0232]; see also US imaging mode in [0246] and Doppler imaging mode in [0231]-[0236]).
Regarding claim 20, Yang discloses the adjustment of the probe include adjusting at least one of a rotation angle or an elevation angle of the probe (one or more subsequent 2D scan planes are acquired following rotation of the transducer by a rotation angle, [0127] ]; one or more subsequent 2D scan planes are acquired following elevation tilt of the transducer by an elevation angle, [0224]).
Regarding claim 24, Yang does not appear to disclose the intervening measure includes an adjustment of a cardiovascular control determinant.
However, in the same field of endeavor of echocardiography, Murphy teaches the intervening measure includes an adjustment of a cardiovascular control determinant (automatically selected intervention/treatment adjusts a cardiovascular control determinant, [0014]-[0017]; [0034]-[0037], [0153], [0164], [0167], [0179]-[0184], [0193], [0201], [0206]-[0215]; see also various physiological and hemodynamic states that may be adjusted, [0234]-[0269]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Murphy’s known technique of selecting an intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the echocardiography images to a database of images of healthy/normal hearts to Yang’s known apparatus that determines the physiological and hemodynamic state of a patient’s heart in echocardiography images to achieve the predictable result that using echocardiographic assessment of the heart and comparison to a database of healthy/normal heart images allows the selection of “an appropriate treatment to restore the cardiac system to its optimal or best acceptable condition” Murphy, [0089].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in further view of Murphy as in claim 11 above, and further in view of Specht.
Regarding claim 13, Yang discloses the window includes a transthoracic window (place ultrasound transceiver to capture a transthoracic view, [0068], [0069], [0118], [0204], [0242], [0247], [0256], [0333], [0334], [0349], [0375]).
However, Yang in further view of Murphy does not appear to disclose the window includes at least one of: a transthoracic parasternal window, a sub-costal window, or a suprasternal notch window.
However, in the same field of endeavor of echocardiography, Specht teaches the window includes at least one of: a transthoracic parasternal window, a sub-costal window, or a suprasternal notch window (ultrasound probe for echocardiography is placed at the transthoracic parasternal window or sub-costal window, [0069]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Specht’s known technique of placing an ultrasound probe at either the parasternal or subcostal window for transthoracic echocardiography to Yang in further view of Murphy’s known process employing an ultrasound echocardiography probe positioned at a transthoracic window to achieve the predictable result that for echocardiography the ultrasound probe may be positioned at the transthoracic parasternal window or the sub-costal window as available to achieve a clear view of the heart. See, e.g., Specht, [0069].
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in further view of Murphy as in claim 16 above, or, in the alternative, Yang in further view of Murphy in further view of Baba.
Regarding claim 23, Yang does not appear to disclose the comparison is performed by a correlation algorithm based on one or more defined pattern correlations.
However, in the same field of endeavor of echocardiography, Murphy teaches the comparison is performed by a correlation algorithm based on one or more defined pattern correlations (images from echocardiography, [0099]; automatically select intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the heart images to a database of images/models of healthy/normal hearts, [0014]-[0017]; [0034]-[0037], [0153], [0164], [0167], [0179]-[0184], [0193], [0201], [0206]-[0215]; see also various physiological and hemodynamic states, [0020]-[0032], [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Murphy’s known technique of selecting an intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the echocardiography images to a database of images of healthy/normal hearts to Yang’s known apparatus that determines the physiological and hemodynamic state of a patient’s heart in echocardiography images to achieve the predictable result that using echocardiographic assessment of the heart and comparison to a database of healthy/normal heart images allows the selection of “an appropriate treatment to restore the cardiac system to its optimal or best acceptable condition” Murphy, [0089].
Additionally, or, in the alternative, Yang in further view of Murphy may not explictly disclose that the comparison is performed by a correlation algorithm based on one or more defined pattern correlations.
However, in the same field of endeavor of echocardiography, Baba teaches the comparison is performed by a correlation algorithm based on one or more defined pattern correlations (measurement items for various cardiac diseases are automatically determined for the patient echocardiography image by comparison between a database of echocardiography images of able-bodied and disable-bodied persons categorized by each of the measurement items for the various cardiac diseases and the patient echocardiography image using a correlation algorithm, Col. 2, line 42 – Col. 6, line 43; see also Col.6, line 44 - Col. 10, line 48).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Baba’s known technique of applying a correlation analysis of similarity between the patient echocardiography images and a categorized database of able- and disable-bodied echocardiography images to determine a measurement item for various cardiac diseases for the patient to Yang in further view of Murphy’s known apparatus that determines the physiological and hemodynamic state of the patient’s heart using a comparison to a database of healthy/normal heart images to achieve the predictable result that correlation/similarity analysis improves diagnosis efficiency by allowing for easy, quick, and accurate determination of whether a patient has a cardiac disease. See, e.g., Baba, Col. 9, line 56 – Col. 10, line 14.
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.
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Claims 1 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847 (the ‘847 Patent). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 discloses a method for managing a patient (col. 27, lines 57-58) comprising:
obtaining first data corresponding to the patient, the first data captured at a window using a probe (col. 27, lines 59-62; col. 28, lines 22-26, 31-35);
generating at least one image along an imaging cross-section of the window using the first data corresponding to the patient (col. 27, lines 59-62; col. 28, lines 22-26, 31-35);
automatically controlling an adjustment of the probe (col. 28, lines 22-26, 31-35);
obtaining second data corresponding to the patient, the second data captured using the probe following the adjustment of the probe (col. 28, lines 22-26, 31-35);
determining a cardiovascular function status of the patient based on at least one of the first data or the second data (col. 27, line 65 – col.28, line 7); and
generating an intervening measure based on the cardiovascular function status (col. 28, lines 8-10).
Further, claim 7 discloses one or more tangible non-transitory computer-readable storage media storing computer-executable instructions for performing a computer process on a computing system (col. 27, line 63 0 col. 28, line 10).
Claims 2 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 discloses at least one of the first data or the second data includes ultrasound-generated data points (col. 27, line 59 – col.28, line 7).
Claims 3 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 discloses the cardiovascular function status of the patient is determined based on at least one of a cardiac output status, a filling pressure status, or a systolic blood pressure status (col. 27, line 65 – col.28, line 7).
Claims 4 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 discloses the at least one image is a 2D image (col. 28, lines 22-26, 31-35).
Claims 5 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847 in view of Specht.
Claim 7 of the ‘847 Patent discloses the features of claims 1 and 11 as above.
Claim 7 of the ‘847 Patent does not appear to disclose the window includes at least one of: a transthoracic parasternal window, a sub-costal window, or a suprasternal notch window.
However, in the same field of endeavor of echocardiography, Specht teaches the window includes at least one of: a transthoracic parasternal window, a sub-costal window, or a suprasternal notch window (ultrasound probe for echocardiography is placed at the transthoracic parasternal window or sub-costal window, [0069]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Specht’s known technique of placing an ultrasound probe at either the parasternal or subcostal window for transthoracic echocardiography claim 7 of the ‘847 Patent’s known process employing an ultrasound probe at an ultrasound view to achieve the predictable result that for echocardiography the ultrasound probe may be positioned at the transthoracic parasternal window or the sub-costal window as available to achieve a clear view of the heart. See, e.g., Specht, [0069].
Claims 6 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847 in view of Murphy.
Claim 7 of the ‘847 Patent discloses the features of claims 1 and 11 as above.
Claim 7 of the ‘847 Patent does not appear to disclose determining the cardiovascular function status based on a comparison of the at least one image to a set of one or more images having a categorization.
However, in the same field of endeavor of echocardiography, Murphy teaches determining the cardiovascular function status based on a comparison of the at least one image to a set of one or more images having a categorization (images from echocardiography, [0099]; select intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the heart images to a database of images/models of healthy/normal hearts, [0014]-[0017]; [0034]-[0037], [0153], [0164], [0167], [0179]-[0184], [0193], [0201], [0206]-[0215]; see also various physiological and hemodynamic states, [0020]-[0032], [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Murphy’s known technique of selecting an intervention/treatment based on the physiological and hemodynamic state of the patient’s heart from a comparison of the echocardiography images to a database of images of healthy/normal hearts to claim 7 of the ‘847 Patent’s known process of determining a determinant reflecting the condition of the patient from the ultrasound information to achieve the predictable result that using echocardiographic assessment of the heart and comparison to a database of healthy/normal heart images allows the selection of “an appropriate treatment to restore the cardiac system to its optimal or best acceptable condition” Murphy, [0089].
Claims 7 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847 in view of Yang.
Claim 7 of the ‘847 Patent discloses the features of claims 1 and 11 as above.
Claim 7 of the ‘847 Patent does not appear to disclose the adjustment of the probe includes adjusting a probe mode, wherein the probe mode includes at least one of a color Doppler image mode or a spectral Doppler image mode.
However, in the same field of endeavor of echocardiography, Yang teaches the adjustment of the probe includes adjusting a probe mode, wherein the probe mode includes at least one of a color Doppler image mode or a spectral Doppler image mode (ultrasound imaging and Doppler imaging modes, [0206], [0214], [0241]; continuous wave or pulse/parallel wave Doppler imaging, i.e., spectral Doppler imaging, [0231]-[0232]; see also US imaging mode in [0246] and Doppler imaging mode in [0231]-[0236]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Yang’s known technique of switching between US and spectral Doppler imaging modes to claim 7 of the ‘847 Patent’s known process of ultrasound imaging to achieve the predictable result that Doppler imaging provides increases the amount of information available to assess the patient’s heart by providing the ability to independently obtain velocity information. See, e.g., Yang, [0231]-[0233].
Claims 10 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847 in view of Yang.
Claim 7 of the ‘847 Patent discloses the features of claims 1 and 11 as above.
Claim 7 of the ‘847 Patent does not appear to disclose the adjustment of the probe include adjusting at least one of a rotation angle or an elevation angle of the probe.
However, in the same field of endeavor of echocardiography, Yang teaches the adjustment of the probe include adjusting at least one of a rotation angle or an elevation angle of the probe (one or more subsequent 2D scan planes are acquired following rotation of the transducer by a rotation angle, [0127]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Yang’s known technique of acquiring ultrasound views at different rotation angles to claim 7 of the ‘847 Patent’s known process of ultrasound imaging to achieve the predictable result that automated acquisition of a 3D ultrasound dataset allows for non-invasive and accurate heart information. See, e.g., Yang, [0006]-[0008].
Claims 21 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847 in view of Baba.
Claim 7 of the ‘847 Patent discloses the features of claims 6 and 16 as above.
Claim 7 of the ‘847 Patent does not appear to disclose the comparison is performed by a correlation algorithm based on one or more defined pattern correlations.
However, in the same field of endeavor of echocardiography, Baba teaches the comparison is performed by a correlation algorithm based on one or more defined pattern correlations (measurement items for various cardiac diseases are determined for the patient echocardiography image by comparison between a database of echocardiography images of able-bodied and disable-bodied persons categorized by each of the measurement items for the various cardiac diseases and the patient echocardiography image using a correlation algorithm, Col. 2, line 42 – Col. 6, line 43; see also Col.6, line 44 - Col. 10, line 48).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Baba’s known technique of applying a correlation analysis of similarity between the patient echocardiography images and a categorized database of able- and disable-bodied echocardiography images to determine a measurement item for various cardiac diseases for the patient to Claim 7 of the ‘847 Patent’s known process of developing a determinant reflecting a condition of the patient to achieve the predictable result that correlation/similarity analysis improves diagnosis efficiency by allowing for easy, quick, and accurate determination of whether a patient has a cardiac disease. See, e.g., Baba, Col. 9, line 56 – Col. 10, line 14.
Claims 22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,348,847. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 discloses the intervening measure includes an adjustment of a cardiovascular control determinant (col. 27, line 65 – col. 28, line 10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ishikawa et al. (U.S. Pub. No. 2011/0246129) discloses the adjustment of the probe is based on a comparison of the at least one image to a set of one or more images (automatic repositioning and/or rotation of the ultrasonic probe based on relationship between acquired images and template images, [0060]-[0066]; see also [0068]-[0114] describing a detailed embodiment of comparing the contour of the acquired image to the contour of the template image to determine the repositioning and/or rotation of the US probe).
Chandratatna et al. (WO 01/12068 A1), discloses a method for managing a patient (performing ultrasound examination for monitoring applications, P.10, ¶2) comprising:
obtaining first data corresponding to the patient, the first data captured at a window using a probe (obtaining apical four chamber view, P.3, ¶3);
generating at least one image along an imaging cross-section of the window using the first data corresponding to the patient (apical four chamber view is a 2D ultrasound image plane, P.3, ¶3, P.,6, ¶3, Figs. 6A and 6B, P.6, ¶5 – P.7, ¶1, Fig. 8, P.7, ¶2, Fig. 9, P.8, ¶2, Fig. 11B);
automatically controlling an adjustment of the probe (automatic switching between apical four chamber view and two chamber view, P.3, ¶3);
obtaining second data corresponding to the patient, the second data captured using the probe following the adjustment of the probe (obtaining apical two chamber view, P.3, ¶3); and
determining a cardiovascular function status of the patient based on at least one of the first data or the second data (calculate cardiac output from short axis view, P.12, ¶3).
Skidmore (U.S. Patent No. 5,575,289) discloses a method for managing a patient comprising: obtaining first data corresponding to the patient, the first data captured at a window using a probe; generating at least one image along an imaging cross-section of the window using the first data corresponding to the patient; automatically controlling an adjustment of the probe; obtaining second data corresponding to the patient, the second data captured using the probe following the adjustment of the probe; and determining a cardiovascular function status of the patient based on at least one of the first data or the second data.
Chouno (U.S. Pub. No. 2010/0074475) discloses a system and method for ultrasound imaging of specific imaging windows to automatically determine reorientation parameters for a probe based on a contour and a real-time image and superimposing the contour and the real-time image for display.
Takeuchi (U.S. Pub. No. 2004/0019270) discloses a system and method for echocardiography of specific image windows and simultaneously displaying a template contour and a real-time image and providing instructions to align the contour and image by matching the displayed contour and image.
Urbano et al. (U.S. Patent No. 6,004,270) discloses a system and method for ultrasound imaging of anatomical objects in a region of interest and superimposing a template contour and a real-time image and providing instructions to align the contour and image by matching the displayed contour and image.
Toma et al. (U.S. Pub. No. 2014/0081142) discloses a system, method, and CRM for ultrasound imaging of specific imaging windows to automatically determine reorientation parameters for a probe based on a contour and a real-time image and superimposing the contour and the real-time image for display.
Francis et al. (U.S. Pub. No. 2015/0327838) discloses a system and method for echocardiography of specific image windows using landmarking of the image heart windows to automatically determine reorientation parameters for a probe.
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/J.M./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798