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 Interpretation
Claim 1 recites “electronically automatically generating an alert if a potential adverse heart event is detected” which is a contingent limitation. Per MPEP 2111. 04 subsection II: “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B.”
Claim Objections
Claims 2-3, 5-6, and 8 are objected to because of the following informalities:
Claim 1 recites the limitation “a heart” in line 5 which should be changed to –the [[a]] heart—because the preamble previously recites a heart.
Claim 2 recites “the electronically monitoring the status” which should be changed to –the electronically automatically monitoring the status—in order to have proper antecedent basis.
Claim 3 recites “the electronically monitoring status” which should be changed to –the electronically automatically monitoring the status—in order to have proper antecedent basis and to avoid a potential indefiniteness issue.
Claim 5 recites “the electronically monitoring the status” which should be changed to –the electronically automatically monitoring the status—in order to have proper antecedent basis.
Claim 6 recites “hear beat” which appears to be a typographical error that should be corrected to –heartbeat--.
Claim 8 recites “the electronically monitoring the status” which should be changed to –the electronically automatically monitoring the status—in order to have proper antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a potential adverse heart event” in the last paragraph of the claim which renders the claim indefinite because it is unclear whether this is the same or different potential adverse heart event previously recited in the previous paragraph of the claim. For the present purposes of examination, the limitations have been interpreted as being the same. Further clarification is required.
Claims dependent upon a claim rejected under 35 U.S.C. 112(b) are also rejected under the same statute because they each inherit the indefiniteness of the claim(s) they respectively depend upon.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Analysis step 1 of Subject Matter Eligibility Test
The claims are directed to a process (i.e. a method of monitoring a heart of a patient during an MRI scan session) of claims 1-9.
Analysis step 2A, Prong I
The claims recite abstract ideas, in particular mathematical concepts.
Claim 1 recites “electronically automatically monitoring status of the heart of the patient during the MRI scan session to detect a potential adverse heart event during the MRI scan session based on the obtained SENC MRI images” which is disclosed as a calculation in at least paragraphs [0085], [0086], [0190], [0194] of the pre-grant publication (pgpub) of the instant application. Claim 8 recites “wherein the electronically monitoring the status of the heart of the patient comprises comparing strain measurements of different chambers of the heart or different regions of the heart using the obtained SENC MRI images to identify dyssynchrony based on a spatial non-uniformity of strain over a cardiac cycle” which is a calculation. Claim 9 recites “further comprising electronically determining diastolic strain measurements of the heart of the patient using the obtained series of SENC MRI images of a heart from long and short axis planes to evaluate at least one of cardiac function, impairment, disease or injury” which is disclosed as a calculation in at least paragraphs [0041], [0042], [0060], [0209], [0210] of the pgpub of the instant application.
Claim 2 merely further limits the abstract idea recited in claim 1. Claim 3 recites “wherein the electronically monitoring status of the heart is carried out periodically during the MRI scan session as an addition to or an alternative to EKG monitoring during the MRI scan session of the patient for non-cardiac MRI imaging” which merely further limits the abstract idea recited in claim 1. Claim 5 merely further limits the abstract idea recited in claim 1.
Analysis step 2A, Prong II
The judicial exception is not integrated into a practical application because the additional elements of the claim are mere instructions to implement the abstract idea on a computer and the additional elements of the claim merely add insignificant extra-solution activity to the judicial exception. See MPEP 2106.05 (f) and (g).
Claims 1 and 9 recite several instances of the limitation “electronically” which is, as disclosed in at least paragraph [0101] of the pgpub, mere instructions to implement the abstract idea on a computer.
Claim 1 recites “electronically obtaining a series of strain encoded (SENC) MRI images of a heart of the patient during the MRI scan session” which is insignificant extra-solution activity, in particular mere data gathering. Claims 4, 6, and 7 merely further limits this additional element.
Claim 1 also recites “electronically automatically generating an alert if a potential adverse heart event is detected” which is insignificant extra-solution activity, in particular post-solution activity or insignificant application.
Claim 3 recites “further comprising obtaining MRI images of non- cardiac target anatomy of the patient during the MRI scan session” which is insignificant extra-solution activity, in particular mere data gathering.
Analysis step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because performing the processes electronically is an additional element that merely results in instructions to implement an abstract idea on a computer that is well-understood, routine, and conventional activity previously known to the industry. The remaining additional elements, mentioned above, merely add insignificant extra solution activity, in particular mere data gathering and post-solution activity and insignificant application, to the judicial exception that are well-understood, routine, and conventional activities previously known to the industry.
Claims 1-9 are therefore directed to a judicial exception without significantly more. The claims are not patent eligible.
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 1-2 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Maier (US 2009/0093707, April 9, 2009) in view of Osman (US 2008/0315877, December 25, 2008).
Regarding claim 1, Maier discloses a method of monitoring a heart of a patient during an MRI scan session (“A method for monitoring cardiac function of a patient during a magnetic resonance imaging (MRI) procedure” Abstract), comprising:
electronically (see “processor” in [0016]) obtaining a series of MRI images of a heart of the patient during the MRI scan session (“acquiring an MR image sequence of the patient's heart during a cardiac phase” [0007]);
electronically automatically (see “program” and “processor” in [0016]; also see [0046]) monitoring status of the heart of the patient during the MRI scan session to detect a potential adverse heart event during the MRI scan session based on the obtained SENC MRI images (“segmenting a left ventricle of the patient's heart in the MR image sequence, wherein the segmentation produces endocardial and epicardial contours; representing at least one of the contours in polar or radial coordinates and computing its Fourier transform, wherein the Fourier transform produces Fourier descriptors for the contour; putting a vector of the Fourier descriptors into a classifier, wherein the classifier determines whether the contour reflects normal wall motion in the cardiac phase or whether the contour reflects abnormal wall motion in the phase” [0007]); and
electronically automatically (see “program” and “processor” in [0016]) generating an alert if a potential adverse heart event is detected (“alerting a medical practitioner when abnormal wall motion is detected” [0007]).
Maier fails to disclose that the series of MRI images is a series of strain encoded (SENC) MRI images.
However, Osman teaches, in the same field of endeavor, a series of strain encoded (SENC) MRI images (“Imaging Tissue Deformation Using Strain Encoded Mri” Title).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Maier with a series of strain encoded (SENC) MRI images as taught by Maier in order to image regional deformation of the heart and assess heart function (Abstract, [0008] of Osman).
Regarding claim 2, Maier further discloses wherein the electronically monitoring the status of the heart is carried out as an addition to or an alternative to EKG monitoring during a cardiac MRI of the patient during the MRI scan session (“The present invention relates to monitoring cardiac function of a patient during a magnetic resonance imaging (MRI) procedure, and more particularly, a method and system for monitoring cardiac function of a patient during an MRI procedure without an electrocardiogram (ECG).” [0003]).
Regarding claim 4, Maier modified by Osman discloses the limitations of claim 1 as stated above and Maier further discloses wherein the electronically obtained series of SENC MRI images is carried out periodically during the MRI scan session of the patient whereby impact of stressors on the patient is monitored throughout the MRI scan session (“When the classifier determines that the contour reflects normal wall motion the contour is classified as systole or diastole, the method further comprises: acquiring a next MR image sequence of the patient's heart during a next cardiac phase” [0015]; also see “MRI stress test” in [0014]).
Regarding claim 5, Maier further discloses wherein the electronically monitoring the status of the heart is automatically carried out periodically during the MRI scan session of the patient while the patient is in a bore of a magnet of an MRI system performing the MRI scan session (“When the classifier determines that the contour reflects normal wall motion the contour is classified as systole or diastole, the method further comprises: acquiring a next MR image sequence of the patient's heart during a next cardiac phase” [0015]; also see “During A Magnetic Resonance Imaging (MRI) Procedure” in Title).
Regarding claim 6, Maier modified by Osman discloses the limitations of claim 1 as stated above and Maier further discloses wherein the obtained series of SENC MRI images of the heart is repeated periodically during the MRI scan session, and wherein each obtained series is obtained over a respective single hear beat of the patient (“When the classifier determines that the contour reflects normal wall motion the contour is classified as systole or diastole, the method further comprises: acquiring a next MR image sequence of the patient's heart during a next cardiac phase” [0015]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Maier in view of Osman as applied to claim 1 above and further in view of Min et al. (US 8,200,334 B1, June 12, 2012).
Regarding claim 3, Maier modified by Osman discloses the limitations of claim 1 as stated above. Osman further discloses wherein the electronically monitoring status of the heart is carried out periodically during the MRI scan session as an addition to or an alternative to EKG monitoring during the MRI scan session of the patient (“The present invention relates to monitoring cardiac function of a patient during a magnetic resonance imaging (MRI) procedure, and more particularly, a method and system for monitoring cardiac function of a patient during an MRI procedure without an electrocardiogram (ECG).” [0003]; also see [0015]).
Maier is silent on further comprising obtaining MRI images of non-cardiac target anatomy of the patient during the MRI scan session.
However, Min teaches, in the same field of endeavor, obtaining MRI images of non-cardiac target anatomy of the patient during the MRI scan session (“MRI is an effective, non-invasive magnetic imaging technique for generating sharp images of the internal anatomy of the human body, which provides an efficient means for diagnosing disorders such as neurological and cardiac abnormalities and for spotting tumors and the like.” Col. 1, ll. 26-32; also see “These improvements provide the attending personnel with information needed to determine whether the MRI should be suspended in response to induced tachyarrhythmias or other adverse conditions within the patient.” Abstract).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Maier with further comprising obtaining MRI images of non- cardiac target anatomy of the patient during the MRI scan session as taught by Min in order to determine whether MRI should be suspended in response to adverse conditions in the patient (Abstract of Min).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Maier in view of Osman as applied to claims 1 and 6 above and further in view of Guo et al. (US 2016/0078604, March 17, 2016).
Regarding claim 7, Maier modified by Osman discloses the limitations of claim 6 as stated above. Maier is silent on wherein each obtained series of SENC MRI images of the heart is obtained before or after non-cardiac MRI images of the patient are obtained during the MRI scan session.
However, Guo teaches, in the same field of endeavor, wherein each obtained series of SENC MRI images of the heart is obtained before or after non-cardiac MRI images of the patient are obtained during the MRI scan session (“In accordance with an aspect of the present invention, the method further includes the motion tracking elements being interspersed between 2 consecutive RF pulses. The method can be used for any of the following: 1D projection of 2D and 3D volumes, tracking and correction of respiratory displacement, tracking the respiratory displacement of the heart, the movement of the heart itself caused by the cardiac cycle, and affine or non-rigid movement of the abdomen.” [0020]; also see “imaging organs in the abdominal cavity such as the liver, the kidneys, the pancreas, etc.” [0014]; also see [0013]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Maier with wherein each obtained series of SENC MRI images of the heart is obtained before or after non-cardiac MRI images of the patient are obtained during the MRI scan session as taught by Guo in order to provide more efficient motion compensation (Abstract of Guo).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Maier in view of Osman as applied to claim 1 above and further in view of Nabutovsky et al. (US 2015/0133802, May 14, 2015).
Regarding claim 8, Maier modified by Osman discloses the limitations of claim 1 as stated above but fails to disclose wherein the electronically monitoring the status of the heart of the patient comprises comparing strain measurements of different chambers of the heart or different regions of the heart using the obtained SENC MRI images to identify dyssynchrony based on a spatial non-uniformity of strain over a cardiac cycle.
However, Nabutovsky teaches, in the same field of endeavor, wherein the electronically monitoring the status of the heart of the patient comprises comparing strain measurements of different chambers of the heart or different regions of the heart using the obtained SENC MRI images to identify dyssynchrony based on a spatial non-uniformity of strain over a cardiac cycle (“A method and system are provided for analyzing motion data collected by a cardiovascular navigation system to determine a level of dyssynchrony exhibited by a heart. The method and system comprise obtaining a motion data (MD) set that includes a plurality of map point specific motion data (PSMD) collections of motion data. The motion data in each PSMD collection includes information indicating an amount and direction of motion that occurred at a corresponding map point on a wall of the heart during a select period of time, such as during at least one cardiac cycle. The method and system divide the PSMD collections of data into sectors which may be associated with corresponding phases of the cardiac cycle, and analyze the sectors of the PSMD collections to determine at least one of a slope, a magnitude and a direction of motion at the corresponding map point of the wall of the heart during the associated sector. The method and system assess at least one of the slope, magnitude and direction of motion occurring at the corresponding map points of the wall, and calculate a measure of dyssynchrony in the map points of the wall based on at least one of i) whether the map points move in a select direction during select sectors, ii) whether the map points move by a select amount during the select sectors, iii) a direction of strain waveform during select phases of the cardiac cycle and/or iv) an extent of strain during the select phases.” Abstract; also see Figs. 2A-B, 5A-B and corresponding descriptions).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Maier with wherein the electronically monitoring the status of the heart of the patient comprises comparing strain measurements of different chambers of the heart or different regions of the heart using the obtained SENC MRI images to identify dyssynchrony based on a spatial non-uniformity of strain over a cardiac cycle as taught by Nabutovsky in order to “predict response to CRT as well as optimize LV lead placement and CRT programming parameters” based on dissynchrony assessment ([0003] of Nabutovsky).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Maier in view of Osman as applied to claim 1 above and further in view of Hamilton et al. (US 2011/0009735, January 13, 2011).
Regarding claim 9, Maier modified by Osman discloses the limitations of claim 1 as stated above but fails to disclose further comprising electronically determining diastolic strain measurements of the heart of the patient using the obtained series of SENC MRI images of a heart from long and short axis planes to evaluate at least one of cardiac function, impairment, disease or injury.
However, Osman further teaches, in the same field of endeavor, further comprising electronically determining diastolic (“the software commands the gradient controller 125 to send the gradient pulse 310 at a reference time. An exemplary reference time may be immediately after the R-wave of an echocardiogram at end-diastole, which will enable subsequent tuned imaging to be done during the range of heart motion.” [0040]) strain measurements of the heart of the patient using the obtained series of SENC MRI images of a heart to evaluate at least one of cardiac function, impairment, disease or injury (“system and method for imaging strain of tissue, such as the heart, in a quantitative manner. The present invention provides images of strain, which corresponds to heart function” Abstract; also see [0006]).
Maier modified by Osman fails to disclose long and short axis planes.
However, Hamilton teaches, in the same field of endeavor, long and short axis planes (“The MRI images of wall motion and perfusion of the frames of the cine loops may include corresponding images of different locations of the heart and at different times during the cardiac cycle of the patient (i.e. cine loops may be registered to other cine loops). For example, the images may include slices such as the basal short axis, the long axis, the mid short axis, the apical short axis, four chamber and two chamber slices.” [0036]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Maier with long and short axis planes as taught by Hamilton in order to provide more robust views of the heart of the patient.
Conclusion
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/A.A./ Examiner, Art Unit 3797
/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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