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 .
Response to Election/Restrictions
Applicant’s Election without traverse of Group II (Claims 1, 14-20 and 72-81) in the reply filed on 06/26/2026 is acknowledged.
Applicant’s Election of species 1C (surgical procedure comprises stent placement) and 2B (sensor apparatus is a hand hold stand-alone device; FIG. 7) without traverse in the reply filed on 06/26/2026 is acknowledged. Claims 14, 15, and 17 are being withdrawn as directed to a non-elected invention.
Claim Objections
Claim 80 objected to because of the following informalities. Appropriate correction is required.
In re claim 80, the limitation “At least one computer-readable medium comprising codes stored thereon that, when executed by at least one processor, cause the at least one processor to implement the method of claim 1.” should read “At least one computer-readable medium comprising code stored thereon that, when executed by at least one processor, cause the at least one processor to implement the method of claim 1.”
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 72-74 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.
In re claim 72, the limitation “the second time series of the measurements of the heart in, at least, at least one model associated with at least one respective type of inference.”, raises a clarity concern. Specifically, it is unclear what the limitation “,at least,” adds to the claim that is not already required by “at least one model”. For examination purposes, the limitation will be interpreted as requiring the second time series of the measurements of the heart to be analyzed in at least one model associated with at least one respective type of inference. Examiner notes that claims 73 and 74 inherit the same deficiencies.
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, 16, 18-20 and 72-81 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Independent claims 1, 80 and 81 are directed to a method of analyzing characteristics of a heart of a subject, a computer readable medium and at least one computing device. Thus, the claims are directed to statutory categories of invention.
Step 2A, Prong 1:
Claims 1, 80 and 81 recite the following limitations:
“analyzing at least: a first time series of measurements of the heart and measured during at least a first period of time before at least one surgical procedure on the heart; and a second time series of measurements of the heart measured during at least a second period of time after the at least one surgical procedure on the heart” (mental process)
The dependent claims recite the following limitations
“wherein analyzing the first and second time series of the measurements of the heart comprises comparing, at least, the first and second time series of the measurements of the heart.” (mental process) (claim 18)
“wherein comparing the first and second time series of the measurements of the heart comprises identifying a degree of similarity of the first and second time series of the measurements of the heart.” (mental process) (claim 19)
“wherein identifying the degree of similarity of the first and second time series of the measurements of the heart comprises applying at least one statistical-equivalence test to the first and second time series of the measurements of the heart.” (mental process and/or mathematical calculation) (claim 20)
“analyzing, at least, the second time series of the measurements of the heart in, at least, at least one model associated with at least one respective type of inference.” (mental process and/or mathematical calculation) (claim 72)
The above limitations are examples of mental processes and/or mathematical calculations.
Regarding the limitations directed to a mental process, the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper to be an abstract idea. Examples of mental processes include observation, judgement, evaluation and opinion. The limitations listed above nothing more than a medical professional analyzing a patient’s ECG recording. For example, the medical professional can compare a patient’s ECG recording before surgery to the patients ECG recording after surgery and draw conclusions.
Examiner notes that the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III).
Regarding the limitations directed to a mathematical calculation, under the broadest reasonable interpretation a mathematical calculation is a mathematical operation or an act of calculating using mathematical methods to determine a number of variable. See MPEP 2106.04(a)(2)(I). Examiner notes, as discussed in MPEP 2106.04(a)(2)(I), the claim does not need to recite the word “calculating” in order to be considered a mathematical calculation. It is clear that the limitation “applying at least one statistical-equivalence test to the first and second time series of the measurements of the heart”, is an example of a mathematical calculation.
Examiner notes that claims 16, 73 and 74 include limitations that further limit the abstract idea of analyzing time series data.
For the reasons above, Examiner asserts that the claims recite a judicial exception, specifically an abstract idea (Step 2A, Prong 1: Yes)
Step 2A, Prong 2:
Claims 80 and 81 recite the following additional elements:
“at least one computer readable medium comprising codes stored thereon” (generic computer component)
“at least one processor” (generic computer component)
“at least one computing device” (generic computer component)
The above additional elements are examples of generic computer components. These additional elements fail to provide significantly more because they amount to merely applying the abstract idea using generic computer components.
Dependent claims recite the following additional elements:
“wherein at least the first time series of the measurements of the heart is measured by at least one sensor” (claim 75) (insignificant extra solution activity)
“wherein at least the second time series of the measurements of the heart is measured by at least one sensor.” (claim 76) (insignificant extra solution activity)
“further comprising causing at least one sensor to measure at least the first time series of the measurements of the heart” (claim 77) (insignificant extra solution activity)
“further comprising causing at least one sensor to measure at least the second time series of the measurements of the heart” (claim 78) (insignificant extra solution activity)
“causing at least one signal interface to produce at least one output signal responsive to at least analyzing the first and second time series of the measurements of the heart.” (insignificant extra solution activity) (claim 79)
The additional elements listed above fail to provide significantly more because they amount to insignificant extra solution activity.
Step 2B
The claims do not include any additional elements that amount to significantly more than the judicial exception.
As discussed above, in Step 2A, Prong 2 the remaining additional elements amount to no more than applying the abstract idea using generic computer components and insignificant extra solution activity.
Moreover, reconsidering the claim limitations individually and as an ordered combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101. (Step 2B: NO)
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 16, 18-20 and 72-81 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by John et al. (US 2008/0188763).
In re claim 1, John discloses, a method of analyzing characteristics of a heart of a subject [0009], the method comprising analyzing at least:
a first time series of measurements of the heart and measured during at least a first period of time before at least one surgical procedure on the heart (FIG. 11; [0151]: upper graph of FIG. 11 shows “ST deviation, as a function of heart rate” calculated “from electrogram data computed from a patient before” a “therapeutic stent procedure”) and
a second time series of measurements of the heart and measured during at least a second period of time after the at least one surgical procedure on the heart (FIG. 11; [0151]: lower graph of FIG. 11 shows “ST deviation, as a function of heart rate” calculated “from electrogram data from a patient after” a “therapeutic stent procedure”).
In re claim 16, John discloses, wherein the at least one surgical procedure comprises stent placement (FIG. 11; [0151]: “therapeutic stent procedure”).
In re claim 18, John discloses, wherein analyzing the first and second time series of the measurements of the heart comprises comparing, at least, the first and second time series of the measurements of the heart ([0151, 0152]; additionally see caption on right of bottom graph of FIG. 11).
In re claim 19, John discloses, wherein comparing the first and second time series of the measurements of the heart comprises identifying a degree of similarity of the first and second time series of the measurements of the heart ([0151, 0152]; additionally see caption on right of bottom graph of FIG. 11).
In re claim 20, John discloses, wherein identifying the degree of similarity of the first and second time series of the measurements of the heart comprises applying at least one statistical-equivalence test to the first and second time series of the measurements of the heart ([0059]: “two histograms can be statistically compared”, Examiner notes statistical “comparison” described involves using a “confidence interval” approach which, as known by one of ordinary skill in the art is a statistical-equivalence test)
In re claim 72, John discloses, further comprising analyzing, at least, the second time series of the measurements of the heart in, at least, at least one model (Fig. 3: 566, “conditional module”) associated with at least one respective type of inference ([0121]: FIG. 8 illustrates process performed by “conditional module 556” which is responsible for computing an [0123]: “ischemia score”) .
In re claim 73, John discloses, wherein the at least one model comprises at least one model associated with at least one cardiac disease (FIG. 8; [0123]: “determine whether a patient has ischemia”).
In re claim 74, John discloses, wherein the at least one cardiac disease comprises coronary artery disease (FIG. 8; [0123]: “determine whether a patient has ischemia”; Examiner notes that ischemic heart disease is also called coronary artery disease, as known by those in the art).
In re claim 75, John discloses, wherein at least the first time series of the measurements of the heart is measured by at least one sensor ([0151]: “FIG. 11…calculated from electrogram data”; [0046]).
In re claim 76, John discloses, wherein at least the second time series of the measurements of the heart is measured by at least one sensor ([0151]: “FIG. 11…calculated from electrogram data”; [0046]).
In re claim 77, John discloses, wherein at least further comprising causing at least one sensor to measure at least the first time series of the measurements of the heart ([0151]: “FIG. 11…calculated from electrogram data”; [0046]).
In re claim 78, John discloses, further comprising causing at least one sensor to measure at least the second time series of the measurements of the heart ([0151]: “FIG. 11…calculated from electrogram data”; [0046]).
In re claim 79, John discloses, causing at least one signal interface (Fig. 1B: 522) to produce at least one output signal ([0079]: “an alarm”) responsive to at least analyzing the first and second time series of the measurements of the heart ([0079]: “histogram data” can cause “the monitoring result to trigger an alarm”; [0079]: “algorithms can jointly evaluate past values, current and predicted future values in order to determine if an alarm should be triggered”).
In re claim 80, John discloses, at least one computer readable medium (FIG. 1B: 518) comprising computer codes (519) stored thereon that, when, executed by at least one processor ([0039]: “control module 518, diagnostic module 516, storage module 526 will typically be implemented by a digital processor”), cause the at least one processor to implement the method of claim 1 ([0042]; see above (In re claim 1)).
In re claim 81, John discloses, at least one computing device (FIG. 1B: 500) programmed to implement the method of claim 1 ([0007]; [0008]; [0009]; see above (In claim 1)).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rolland et al. (US 2025/0213128) discloses a method (FIG. 11D, FIG. 11E) for displaying a patient’s pre-procedure and post-procedure electrocardiogram [0173]. As disclosed by Rolland, such a display is advantageous as it allows a clinician to quickly compare hemodynamic information from two different recordings [0173].
Pressler et al. (US 2005/0191278) discloses a method for treating coronary artery disease (abstract). Pressler discloses evaluating a therapeutic effect resulting from the method by measuring/recording parameters of a patient both before and after treatment [0041].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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