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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-4 are directed to a method (process) and claims 5-8 are directed to a system (machine).
Step 2A, Prong One
Regarding claims 1 and 5, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitation(s) of “receiving a set of electrocardiograms (ECG) determined to belong to a given morphologic template indicative of a given type of arrhythmia; using a location algorithm, calculating a percentage of the ECGs in the set that point to a same source location of the given type of arrhythmia; comparing the calculated percentage to a predefined threshold percentage; and if the percentage of ECGs is found to exceed the threshold percentage, reporting the source location to a user” (claim 1) and “receive a set of electrocardiograms (ECG) determined to belong to a given morphologic template indicative of a given type of arrhythmia” and “using a location algorithm, calculate a percentage of the ECGs in the set that point to a same source location of the given type of arrhythmia; compare the calculated percentage to a predefined threshold percentage; and if the percentage of ECGs is found to exceed the threshold percentage, report the source location to a user” is/are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, these limitations are nothing more than reading previously gathered data from a chart or screen, and making a mental calculation comparing these numbers to a predetermined threshold in order to make a diagnosis to report to a patient.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, claim 5 also recites “an interface” and “a processor”. Claim 1 has no structure associated with the claimed functions. The interface and processor are recited at a high-level of generality and amount to nothing more than parts of a generic computer.. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of processor, location algorithm, and interface pertain to generic computer components. Moreover, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, is discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984. See MPEP § 2106.05(d).
Regarding dependent claims 2-3 and 6-7, the limitations of claims 1 and 5 further defines the limitations already indicated as being directed to the abstract idea.
Regarding claims 4 and 8, in the Background of the Applicant’s own application (e.g., par. 0002-0005 of the Published Application), it is shown the 12-lead ECG recorders (e.g., Holter) are well known and routine in the art.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “interface” and “processor” in claim 5.
“interface” corresponds to “a processing interface unit (PIU) 24, e.g., such as that used by a CARTO™ system, produced by Biosense-Webster.” as in par. 0018 of the Published Application
“processor” corresponds to “a general-purpose computer with a suitable front end and interface circuits 38” or “an algorithm” as in par. 0022 of the Published Application
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Min et al (U.S. 7,912,544). Min discloses (col. 8, lines 1-22) receiving a set of electrocardiograms (ECG) determined to belong to a given morphologic template indicative of a given type of arrhythmia (“The timing intervals between sensed events (e.g., P-waves, R-waves, and depolarization signals associated with fibrillation) are then classified by the arrhythmia detector 234 of the microcontroller 220 by comparing them to a predefined rate zone limit (i.e., bradycardia, normal, low rate VT, high rate VT, and fibrillation rate zones) and various other characteristics (e.g., sudden onset, stability, physiologic sensors, and morphology, etc.)”); using a location algorithm, calculating a percentage of the ECGs in the set that point to a same source location of the given type of arrhythmia (col. 26, line 64-col. 27, line 67, especially “A decision block 1816 follows that decides whether the % REGM/QRSECG measure (e.g., X %) is less than a threshold (e.g., % Th). The threshold may be a first, predetermined percentage or fraction of the QRS complex width. For example, if a parameter % Th is set to 50%, then the decision block 1816 decides if X % is less than 50%. If the decision block 1816 decides that the measure (e.g. X %) is less than the threshold (e.g., % th) then synchrony exists per declaration block 1820, otherwise dyssynchrony exists per declaration block 1824. In either instance, the measure may be plotted over time as indicated by plots 1830 and 1834. Such an analysis may indicate whether a patient's ventricular contractions are becoming more or less synchronous.)”; comparing the calculated percentage to a predefined threshold percentage (see previous citation); and if the percentage of ECGs is found to exceed the threshold percentage, reporting the source location to a user (col. 31, lines 25-31, “Relevant test measurements, along with customizable implant data, can be displayed, stored, and/or printed in a comprehensive summary report for the patient's medical records and physician review and/or for other purposes.”).
Regarding claim 2, Min discloses (Table 1) the morphologic template is indicative of a Premature Ventricular Contraction (PVC) type of arrhythmia.
Regarding claim 3, Min discloses (Table 1) reporting the source location comprises reporting an anatomical region within a heart.
Regarding claim 4, Min discloses (col. 26, lines 20-33) the set of ECGs was acquired using a 12-lead ECG recorder.
Regarding claim 5, Min discloses (Figure 24) an interface (col. 30, line 61-col. 31, line 4) configured to receive a set of electrocardiograms (ECG) determined to belong to a given morphologic template indicative of a given type of arrhythmia (“programmer includes…interfaces to ECG”); and a processor (same citation, “programmer includes a processor”), which is configured to: using a location algorithm, calculate a percentage of the ECGs in the set that point to a same source location of the given type of arrhythmia; compare the calculated percentage to a predefined threshold percentage; and if the percentage of ECGs is found to exceed the threshold percentage, report the source location to a user (see above citations for the steps in claim 1, which are relevant here).
Regarding claim 6, Min discloses (Table 1) the morphologic template is indicative of a Premature Ventricular Contraction (PVC) type of arrhythmia.
Regarding claim 7, Min discloses (Table 1) the processor is configured to report the source location by reporting an anatomical region within a heart.
Regarding claim 8, Min discloses (col. 26, lines 20-33) the set of ECGs was acquired using a 12-lead ECG recorder.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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