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 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, 3, 8-12, 20, 23-24, 26-27, 32-36, 44, 48, 53-55 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Following is the analysis under 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) published on January 7
Step 1: Claims 1, 3, 8, 9-12, 20, 23-24, 26-27, 32-36, 44, 48, 53-55 are directed to a “method” (process), or system (apparatus ) and thus meets the requirements for step 1 since the claims are directed toward one of the four statutory categories of invention.
Step 2A, prong one: Independent claim 1 recites the following limitations that when given their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas for the reasons set forth below:
“identifying a diastolic phase of the heart from the cardiac data; identifying in the diastolic phase an early filling phase, an intermediate filling phase, and an atrial contraction phase from the cardiac data (a human can practically perform identification of phases in the mind or with the aid of pen and paper by comparing a graph of cardiac data, like a cardia volume, ECG, PPG, etc.);
determining a left ventricular filling rate (R1) during the early filling phase from the cardiac data; determining a left ventricular filling rate (R2) during the intermediate filling phase from the cardiac data; determining a first left ventricular filling volume (E) during the early filling phase from the cardiac data; determining a second left ventricular filling volume (A) during the atrial contraction phase from the cardiac data (a human can practically perform identification of phases in the mind or with the aid of pen and paper by comparing a graph of cardiac data, like a cardia volume graph vs time, i.e. y axis would be the volume amounts for different phases);
and generating a diastolic function classification based on at least R1, R2, E, and A.” (a human can practically perform classification of data in the mind or with the aid of pen and paper, by having a set of rules regarding the data sets memorized or written on paper and though selection and arrangement).
Step 2A, prong two: Claim 1 recites the following additional elements that when considered individually and as a whole do not integrate the judicial exception into a practical application for the reasons set forth below:
“system or device including at least one processor,” (the system is recited at a high level of generality and is only involved in the insignificant extra-solution activity).
Step 2B: Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and as a whole, they do not add an inventive concept for the same reasons set forth above in step 2A, prong two. Additionally, when reconsidering the limitations that were considered insignificant extra-solution activity, the following evidence shows the limitations are well-understood, routine and conventional functions:
“system or device including at least one processor” (MPEP 2106.05(d) - Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
Claims 3, 8, 11-12, also been rejected because they recite additional limitations that when given their broadest reasonable interpretation fall within the mental processes grouping of abstract ideas. These limitations are merely directed to classifying data which can be performed in the mind or with a piece of paper, by utilizing a given set of rules.
Claims 9, 20, 23-24, does not recite any limitations that add significantly more. All limitations are directed to data gathering which only limits the extra solution activity.
Claims 26-27, 32-36, 44, 48, recite similar limitations and are rejected for same reasons as above. The diastolic function classification module pf claim 26, is also recited at a high level of generality and is only involved in the insignificant extra-solution activity.
Claims 53-55, further recites “determining whether the patient falls in a normal group having a first likelihood of hospital readmission or in an abnormal group having a second likelihood of hospital readmission higher than the first likelihood based on the diastolic function classification; and where the patient falls in the abnormal group, identifying the patient as having an increased likelihood of hospital readmission within a time period.” This is an abstract idea since an experienced human (clinician) can practically perform identifications and predictions in the mind or with the aid of pen and paper by comparing datasets and historical data. The further limitations does not recite any limitations that add significantly more. All limitations are directed to data gathering which only limits the extra solution activity.
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 9, 33 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.
Claims 9, 33 recites “calculating determining a left ventricular filling rate (R3) during the atrial contraction phase, wherein A is determined based on R3.” Firstly it is not clear if there is calculation determination or both, and if they are different from each other. Secondly, spec. ¶0103, R2, R3 and P are measured from volume enhancement, i.e. volume measurement. Claims suggest volume computation form R3. This is confusing. Examiner interprets that volume and rates can be computed from graph.
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, 3, 9-12, 20, 24, 26-27, 34-36, 44, 48, 53-55 rejected under 35 U.S.C. 103 as being unpatentable over Moro [US 20140275976 A1] in view of Schweitzer [Assessment of left sided filling dynamics in diastolic dysfunction using cardiac computed tomography, European Journal of Radiology 84 (2015) 1930–1937].
As per claim 1, Moro teaches a method for assessing cardiac function of a heart of a subject performed by a system or device including at least one processor (Moro Fig 27),
the method comprising: receiving or accessing cardiac data obtained from imaging one or more complete cardiac cycles of the heart (Moro Fig 1, Fig 27, ¶0116, cardiac volume data from imaging of subject);
identifying a diastolic phase of the heart from the cardiac data; identifying in the diastolic phase an early filling phase, an intermediate filling phase, and an atrial contraction phase from the cardiac data (Moro Fig 1, ¶0052 phases A, B, P corresponding to phases E, M, A as in applicant spec. ¶0086);
determining a left ventricular filling rate (R1) during the early filling phase from the cardiac data; determining a left ventricular filling rate (R2) during the intermediate filling phase from the cardiac data (Moro Fig 1, R1 and R2, ¶0017);
generating a diastolic function classification based on at least R1, R2, (Moro ¶0054 “A first diastolic index (MI) is formed 106 from a combination of the initial and intermediate volume change rates of the first volumetric flow (R1/R2, R2/R1, or R1.times.R2 by way of example)….” ¶0057 “diagnostic indices determined, such as illustrated with reference to the Table of FIG. 7 for normal, mild, moderate and severe conditions during … illustrated in FIG. 7, the diastolic index selected for comparison is R1/R2, by way of example…”)
Moro does not expressly teach determining a first left ventricular filling volume (E) during the early filling phase from the cardiac data; determining a second left ventricular filling volume (A) during the atrial contraction phase from the cardiac data, and generating a diastolic function classification based on E and A.
Schweitzer, in a related field of Left ventricular diastolic dysfunction analysis, teaches determining a first left ventricular filling volume during the early filling phase from the cardiac data; determining a second left ventricular filling volume during the atrial contraction phase from the cardiac data (Schweitzer Fig 2, page 1932 “LV early filling volume (LV-E) and LV late filling volume (LV-A) as well as their ratio (LV-E/A) were calculated”), and generating a diastolic function classification based on E and A (Schweitzer page 1934 “LV-E/A increased gradually with increasing grades of DD.”).
Schweitzer thus provides further sets of volumetric/ echo cardiac and CT parameters for analyzing diastolic function, so that presence and severity of DD and classify as normal or those between grades 1-3 DD according to ASE (Schweitzer page 1931 RHS). Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the method in Moro by integrating different parameters for analysis and diastolic function, (including those noted by Schweitzer like LV-E, LV-A, CV, etc.) for at least the following two reasons. Firstly, analysis using different /additional parameters and functions for identifying the presence and severity of DD, would serve as a secondary method of identifying, characterizing, grading and confirming DC. Secondly, as noted in Schweitzer (conclusion), simultaneous LV and LA volume curves provide new insights into the pathophysiology of diastolic function.
As per claim 3, Moro in view of Schweitzer further teaches wherein the diastolic function classification is based, at least in part, on at least a ratio of R1:R2 (Examiner chooses this. Moro ¶0054),or
(ii) wherein the classification based on E is based on E as a percentage of the ventricular total filling volume (E%), as a percentage of a body surface area (Ei), or a combination of the two (Ei%); or (iii) wherein the classification based on at least R1, R2, E, and A is based on A as a percentage of the ventricular total filling volume (A%), as a percentage of a body surface area (AD, or a combination of the two (Ai%); or(iv) one or more of (i), (ii), and (iii).
As per claim 9, in view of 112 rejection above, Moro in view of Schweitzer further teaches further comprising calculating determining a left ventricular filling rate (R3) during the atrial contraction phase, wherein A is determined based on R3 (Schweitzer Fig 2 slope of curve at LV-A, LV-A is the volume).
As per claims 10, Moro in view of Schweitzer further teaches wherein the diastolic function classification includes one of normal, an early enhanced, a mid- enhanced, an atrial enhanced, an aerobic enhanced, a delayed filling, a restrictive/constrictive or a hypovolemic classification (Moro Fig 7 shows normal classification based on R1/R2).
As per claim 11, Moro in view of Schweitzer does not expressly teach or wherein the diastolic function classification includes four classifications selected from the group consisting of: normal, an early enhanced, a mid-enhanced, an atrial enhanced, an aerobic enhanced, a delayed filling, a restrictive/constrictive, and a hypovolemic classification. However, this is only directed to creating and arranging (assigning), different classifications or names to different data sets. As noted by applicant, The American Society of Echocardiography (ASE) 2016 Guidelines have significantly simplified diastolic performance grading into Normal, Grades 1, 2, 3, and Indeterminate. This invention is only directed to reclassifying and renaming datasets for ease of use. This is not industry standard. The measurements and graphs for cardiac output as in Moro in view of Schweitzer are available and a person of ordinary skill can analyze understand and classify data, however they desire, different from standards used by others (In this case ASE). Examiner finds, the creation and use of a data set, with multiple parameters, would have been an obvious modification, since it would have help user understand readings from different perspectives. However, the accepted classification for industry would still be based on ASE (Since these classifications as recited by applicant is not a standard at the time of filing of invention).
As per claim 12, Moro in view of Schweitzer does not expressly teach classification based on the R1:R2 ratio, E% and A%. However, this is only directed to classifying data sets according to a new basis, different from ASE standard and is rejected for same reason as applied to claim 11 above.
As per claim 20, Moro in view of Schweitzer further teaches the system or device displaying information regarding the generated diastolic function classification or a representation of the generated diastolic function classification on a display (Examiner chooses this. Moro Fig 27, ¶0116): or further comprising transmitting information regarding the generated diastolic function classification to a health care provider or health care system of the subject.
As per claim 24, Moro in view of Schweitzer further teaches imaging the heart during one or more complete cardiac cycles to generate the cardiac data, wherein imaging the heart includes imaging using at least one of echocardiography, computed tomography (CT), and magnetic resonance imaging (Moro ¶0116).
As per claims 26-27, 33-36, 44, 48 have limitations similar to claims 1, 3, 9-12, 20, 24 and are rejected for same reasons as above. A diastolic function classification module, is inherently required.
As per claim 53, Moro in view of Schweitzer further teaches to obtain a diastolic function classification of the patient's heart; determining whether the patient falls in a normal group having a first likelihood of hospital readmission or in an abnormal group having a second likelihood of hospital readmission higher than the first likelihood based on the diastolic function classification (Moro Fig 7, normal vs abnormal groups); and where the patient falls in the abnormal group, identifying the patient as having an increased likelihood of hospital readmission within a time period (this is claimed as a result of falling in an abnormal group).
As per claims 54-55, Moro in view of Schweitzer wherein the diastolic function classifications include normal, atrial enhanced, early enhanced, mid enhanced, delayed filling, restrictive/constrictive, and hypovolemic; wherein the normal group includes the diastolic function classifications normal, atrial enhanced, and early enhanced; and wherein the abnormal group includes the diastolic function classifications mid enhanced, delayed filling, restrictive/constrictive, and hypovolemic, determining a Volume Curve Moro Index (VCM1) from the cardiac data, the VCM corresponding to a likelihood of hospital readmission within the diastolic function classification, with a lower VCMI value corresponding to a higher likelihood of hospital readmission within the specified time period and a higher lower VCMI value corresponding to a lower likelihood of hospital readmission within the specified time period. However these are directed to looking at and analyzing data sets and determining if there is a likelihood of readmissions. An experienced physician could identify form data sets that individual in abnormal group has an increased likelihood of hospital readmission.
Claims 8, 32 rejected under 35 U.S.C. 103 as being unpatentable over Moro in view of Schweitzer as applied to claims 1, 26 above, and further in view of Carlsson [Cardiac output and cardiac index measured with cardiovascular magnetic resonance in healthy subjects, elite athletes and patients with congestive heart failure, Journal of Cardiovascular Magnetic Resonance 2012, 14:51].
As per claims 8, 26, Moro in view of Schweitzer does not expressly teach wherein the classification is further based on a minute ventricular output (MVO) that is body surface area (BSA) indexed (MVOi).
Carlsson, in a related field of quantification of cardiac output teaches wherein the classification is further based on a minute ventricular output (MVO) that is body surface area (BSA) indexed (MVOi) (Carlsson page 2 LHS “CO is the sum of the systemic flow per minute and calculated by the product of stroke volume and heart rate. The ability of the body to adapt to increased workload and hence metabolism is the result of the ability of the heart to increase heart rate and stroke volume [1]. CO indexed to body surface area (BSA) or cardiac index (CI)”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the method to utilize CI as in Carlsson so as to make assessments of heart conditions and critically ill patients (Carlsson page 2 LHS).
Claim 23 rejected under 35 U.S.C. 103 as being unpatentable over Moro in view of Schweitzer as applied to claim 1 above, and further in view of Keel [US 20100228136 A1].
As per claim 23, Moro in view of Schweitzer further teaches where the generated diastolic function classification is hypovolemic classification (Moro Figs 6-7). Moro in view of Schweitzer does not expressly teach transmitting an alert to a health care provider or a health care system of the subject.
Keel, in a related field of monitoring a patient's diastolic function teaches, transmitting an alert to a health care provider or a health care system of the subject (Keel ¶0034 “a patient's diastolic function and/or heart failure (HF) condition can be monitored … tracked to monitor a patient's worsening (or improving) diastolic function, and to trigger alerts and/or therapy (e.g., titration of medications)”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the method in Moro in view of Schweitzer by transmitting alert or notifying alerts so as to inform personnel to take decisions and provide care and treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/Primary Examiner, Art Unit 3797