DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/10/2026 has been entered.
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 Amendment
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
Notice to Applicant
In the amendment dated 03/10/2026, the following has occurred: claims 1 and 22-23 have been amended; claims 2-13, and 16-20 remain unchanged; claims 14-15 and 21 have been canceled; and no new claims have been added.
Claims 1-13, 16-20, and 22-23 are pending.
Effective Filing Date: 09/15/2021
Response to Arguments
35 U.S.C. 101 Rejections:
Step 2A, Prong One:
Applicant argues that the claims are not directed towards an abstract idea classified under Certain Methods of Organizing Human Activity or managing personal behavior. Examiner however respectfully disagrees as the claims do indeed recite an abstract idea categorized under that above-mentioned grouping. For example, a person can classify a patient based on their data. Applicant further states that this is not a sub-grouping. Examiner however respectfully disagrees as classifying a patient based on their data falls under the managing interactions between people subgrouping.
Step 2A, Prong, Two:
Applicant also argues that the claims as a whole integrate the abstract idea into a practical application. Examiner however respectfully disagrees as the claims include additional elements which do not integrate with the abstract idea to provide a practical application.
Applicant further states that the present claim 1 expressly recites specific details on how the system classifies the patient with suspected ACS, including selection of a classification algorithm to be applied based on a second time-point, which in turn is based on a defined interval from a first time-point at which a first sample was obtained. Applicant also states that the amended claim language place meaningful limitations on the claimed subject matter. Examiner however respectfully disagrees that the present claims provide a practical application as the claims still recite steps which humans could perform, using generic computing components. There are no additional elements other than those which are considered as generic computing components.
Step 2B:
With respect to Step 2B, Applicant argues that the ordered combination of the claim limitations amount to significantly more than the abstract idea. Examiner however respectfully disagrees. The additional elements appear to computerize an abstract concept. cites Berkheimer and states that Applicant does not set forth factual evidence to meet the criteria of this step.
Applicant further argues with respect to Berkheimer and states that the claim limitations are not well-understood, routine, or conventional activity. Examiner however respectfully disagrees as Examiner is not claiming that limitations other than the additional elements are well-known or well-understood. These limitations are merely considered to be part of the abstract idea.
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 1-13, 16-20, and 22-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-13 and 16-20 are drawn to a method, claim 22 is drawn to a device, and claim 23 is drawn to a media, each of which is within the four statutory categories. Claims 1-13, 16-20, and 22-23 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a computer-implemented method for classifying a patient with suspected acute coronary syndrome (ACS), comprising the steps of:
1) (a0) analyzing or having analyzed a first sample obtained from the patient to measure an amount of cardiac Troponin in the first sample, wherein the first sample is a human fluid sample,
2) (a) receiving, by a) a processing unit, information on a first time-point at which the first sample has been obtained from the patient at presentation;
3) (b) providing, by the processing unit, on b) a display (where the display may or may not be a computer display):
3a) b1) a proposal for a second time-point at which a second sample shall be obtained from the patient, wherein the second time-point is within an interval of about 1 hour after the first time-point or an interval of about 2 hours after the first time-point, wherein the interval of about 1 hour is between 30 and 90 minutes after the first time-point, and the interval of about 2 hours is between 91 and 150 minutes after the first time-point, and
3b) b2) a proposal for an ACS classification algorithm to be applied for the classification of the patient, wherein the ACS classification algorithm is based on the second time-point proposed in step b1);
4) (c0) analyzing or having analyzed the second sample to measure an amount of cardiac Troponin in the second sample, wherein the second sample is a human fluid sample,
5) (c) receiving, by the processing unit:
5a) c1) information on an actual time-point at which the second sample has been obtained,
5b) c2) a value for the amount of cardiac Troponin measured in the first sample, and
5c) c3) a value for the amount of the cardiac Troponin measured in the second sample;
6) (d) analyzing, by the processing unit, whether the second sample has been obtained within the interval under b1);
7) (e) classifying the patient, by the processing unit, wherein:
7a) e1) classifying the patient comprises classifying the patient based on the ACS classification algorithm proposed in step b2), if the second sample has been obtained within the interval proposed in step b1), or
7b) e2) classifying the patient comprises classifying the patient with an ACS classification algorithm which differs from the ACS classification algorithm proposed in step b2), if the sample has not been obtained within the interval proposed in step b1), and
8) (f) providing, by the processing unit, information on the classification of the patient on the display.
Claim 1 recites, in part, performing the steps of 1) (a0) analyzing or having analyzed a first sample obtained from the patient to measure an amount of cardiac Troponin in the first sample, wherein the first sample is a human fluid sample, 2) (a) receiving information on a first time-point at which a first sample has been obtained from the patient at presentation, 3) (b) providing on a display (where the display may be a piece of paper): 3a) b1) a proposal for a second time-point at which a second sample shall be obtained from the patient, wherein the second time-point is within an interval of about 1 hour after the first time-point or an interval of about 2 hours after the first time-point, wherein the interval of about 1 hour is between 30 and 90 minutes after the first time-point, and the interval of about 2 hours is between 91 and 150 minutes after the first time-point, and 3b) b2) a proposal for an ACS classification algorithm to be applied for the classification of the patient, wherein the ACS classification algorithm is based on the second time-point proposed in step b1), 4) (c0) analyzing or having analyzed the second sample to measure an amount of cardiac Troponin in the second sample, wherein the second sample is a human fluid sample, 5) (c) receiving: 5a) c1) information on an actual time-point at which the second sample has been obtained, 5b) c2) a value for the amount of cardiac Troponin measured in the first sample, and 5c) c3) a value for the amount of the cardiac Troponin measured in the second sample, 6) (d) analyzing whether the second sample has been obtained within the interval under b1), 7) (e) classifying the patient wherein: 7a) e1) classifying the patient comprises classifying the patient based on the ACS classification algorithm proposed in step b2), if the second sample has been obtained within the interval proposed in step b1), or 7b) e2) classifying the patient comprises classifying the patient with an ACS classification algorithm which differs from the ACS classification algorithm proposed in step b2), if the sample has not been obtained within the interval proposed in step b1), and 8) (f) providing information on the classification of the patient on the display. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes a method of classifying a patient based on their data. Independent claims 22 and 23 recite similar limitations and are also directed to an abstract idea under the same analysis.
Depending claims 2-13 and 16-20 include all of the limitations of claim 1, and therefore likewise incorporate the above described abstract idea. Depending claim 12 adds the additional steps of “(g) receiving, by the processing unit: g1) information on the actual time-point at which the third sample has been obtained”, and “g2) a value for an amount of the cardiac Troponin in the third sample”; claim 13 adds the additional step of “(h) classifying, by the processing unit, the patient as rule-out or rule- in based on a difference between the value of the amount of cardiac Troponin in the third sample and the value of the amount of cardiac Troponin in the first sample”; claim 19 adds the additional step of “selecting a diagnostic protocol for the classification of the patient prior to performance of step (a)”; and claim 20 adds the additional step of “providing, by the processing unit and in response to a violation of the diagnostic protocol, information corresponding to the violation on the display”. Additionally, the limitations of depending claims 2-11 and 16-18 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-13 and 16-20 are nonetheless directed towards fundamentally the same abstract idea as independent claim 1 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a processing unit, b) a display, and c) a computer-readable storage medium comprising instructions stored thereon to perform the claimed steps.
The a) processing unit, b) display, and c) computer-readable storage medium in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification for a lack of description of anything but what may be considered as generic computing components, see MPEP 2106.05(f)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
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 using a) a processing unit, b) a display, and c) a computer-readable storage medium to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(f) recites that the following limitations are not significantly more:
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention provides a classification utilizing a) a processing unit, b) a display, and c) a computer-readable storage medium, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Mere instructions to apply an exception using generic computer components in the form of WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-13, 16-20, and 22-23 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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