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 .
Prosecution History Summary
Claims 1-20 are pending.
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 1-20 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.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process (claims 13-20), machine (claims 1-12). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A medical device system, comprising:
-a signal receiver circuit configured to receive:
-physiologic information of a patient; and
-chemical information of the patient; and
-an assessment circuit configured to:
-determine a composite health index for the patient as a weighted function of one or more physiologic features of the received physiologic information and one or more chemical features of the received chemical information; and
-generate a composite health index alert as a function of the determined composite health index and an alert threshold.
Examiner states submits that the foregoing underlined limitations constitute: a “mental process” because analyzing information about the patient to evaluate and determine health index and health index alert can all be performed in the human mind.
Furthermore, the foregoing underlined limitation constitute: a “mathematical concept” because using information to determine health index as a weighted function of that information and generating a composite health index alert as a function are mathematical calculations.
Accordingly, the claim recites at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether
the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP
§$2106.04(1D(A)(2), it must be determined whether any additional elements in the claim beyond
the abstract idea integrate the exception into a practical application in a manner that imposes a
meaningful limit on the judicial exception. The courts have indicated that additional elements
merely using a computer to implement an abstract idea, adding insignificant extra solution
activity, or generally linking use of a judicial exception to a particular technological environment
or field of use do not integrate a judicial exception into a “practical application.” MPEP
§2106.05(1(A).
In the present case, the additional limitations beyond the above-noted at least one abstract
idea recited in the claim are as follows (where the bolded portions are the “additional
limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A medical device system (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); figure 6, para. 155), comprising:
-a signal receiver circuit (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 119, general purpose circuit, microprocessor) configured to receive:
-physiologic information of a patient; and
-chemical information of the patient; and
-an assessment circuit (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 119, general purpose circuit, microprocessor) configured to:
-determine a composite health index for the patient as a weighted function of one or more physiologic features of the received physiologic information and one or more chemical features of the received chemical information; and
-generate a composite health index alert as a function of the determined composite health index and an alert threshold.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID(A)(2).
For these reasons, representative independent claim 13 and analogous independent claim
1 do not recite additional elements that integrate the judicial exception into a practical
application. Accordingly, representative independent claim 13 and analogous independent claim
1 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the
abstract idea into a practical application as set forth below:
Claim 2, 14: The claim specifies the assessment circuit to determine the composite health index, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 3: The claim specifies chemical features, which further narrows the abstract idea.
Claims 4-10, 16-20: The claim specifies the assessment circuit to determine, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 11: The claim specifies composite health index, which further narrows the abstract idea.
Claim 12: The claim specifies the assessment circuit to determine, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 15: The claim specifies chemical features and determining using assessment circuit, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims 1 and 13 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
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 discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as receive physiological and chemical information, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); determine composite health index and health index alert, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2, 4-10, and 12, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claim 12 (display), e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); claims 2 (composite health index as a function), 4 (determine threshold as a function, comparison), 5 (determine weight of features as a function), 6 (determine value of composite health index), 7 (determine alert threshold as a function), 8 (determine alert threshold for second range), 9 (determine features of the weighted function as a function), 10 (increase features for third range of values), e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)). 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.
Therefore, whether taken individually or as an ordered combination, claims 1-20
are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Averina et al. (U.S. Publication No. 2019/0008467).
As per claim 1, Averina teaches a medical device system, comprising:
-a signal receiver circuit configured to receive (Averina: para. 59; Data receiver circuit)
-physiologic information of a patient (Averina: para. 59; Receive physiological signals); and
-chemical information of the patient (Averina: para. 59; Receive signals including bio-chemical markers.); and
-an assessment circuit configured to (Averina: para. 68):
-determine a composite health index for the patient as a weighted function of one or more physiologic features of the received physiologic information and one or more chemical features of the received chemical information (Averina: para. 68; Generate a composite signal index using combination of signal metrics.); and
-generate a composite health index alert as a function of the determined composite health index and an alert threshold (Averina: para. 68; Generate composite signal index and select an alert threshold.).
As per claim 2, the system of claim 1 is as described. Averina teaches wherein the assessment circuit is configured to determine the composite health index for the patient as a function of at least two features of the received physiologic information and one or more features of the received chemical information (Averina: para. 68; Generate a composite signal index using combination of signal metrics.).
As per claim 3, the system of claim 1 is as described. Averina teaches wherein the one or more chemical features comprise one or more indications of relative high or low values of the received chemical information with respect to one or more chemical feature thresholds (Averina: para. 42; Thresholds for physiological signals, which also includes chemical signals.).
As per claim 4, the system of claim 3 is as described. Averina teaches wherein the assessment circuit is configured to:
-determine the one or more chemical feature thresholds as a function of the received chemical information over a first time period (Averina: para. 68-69; Trend of the signal is compared to the threshold.); and
-determine the indication of relative high or low values of the received chemical information using a comparison of a value of the received chemical information to the determined one or more chemical feature thresholds (Averina: para. 68-69; Indicate the predictor trend based on the temporal changes based on thresholds.).
As per claim 5, the system of claim 1 is as described. Averina teaches wherein the assessment circuit is configured to determine a weight of the one or more chemical features as a function of a value of the one or more chemical features (Averina: para. 69; Scaled by weight factors based on timing information.).
As per claim 6, the system of claim 5 is as described. Averina teaches wherein the assessment circuit is configured to determine a value of the composite health index that exceeds a value of the alert threshold for a first range of values of the one or more chemical features, independent of the one or more physiologic features (Averina: para. 11; para. 68).
As per claim 7, the system of claim 1 is as described. Averina teaches wherein the assessment circuit is configured to determine the alert threshold as a function of the received chemical information (Averina: para. 68).
As per claim 8, the system of claim 7 is as described. Averina teaches wherein the assessment circuit is configured to determine the alert threshold to increase a sensitivity of the composite health index alert for a second range of values of the one or more chemical features (Averina: para. 7; para. 77-78; Determine alert threshold based on higher sensitivity.).
As per claim 9, the system of claim 1 is as described. Averina teaches wherein the assessment circuit is configured to determine the one or more physiologic features or the one or more chemical features of the weighted function of the composite health index as a function of one or more values of the one or more chemical features (Averina: para. 65, 68).
As per claim 10, the system of claim 9 is as described. Averina teaches wherein the assessment circuit is configured to increase a number of features of the one or more physiologic features or the one or more chemical features of the weighted function for a third range of values of the one or more chemical features (Averina: para. 65; Physiological signals adjusted, specified, and selected by the user.).
As per claim 11, the system of claim 1 is as described. Averina teaches wherein the composite health index includes a composite heart failure index (Averina: para. 68; Composite health index for heart failure.) and the composite health index alert threshold includes a composite heart failure alert threshold (Averina: para. 68), wherein at least one of the one or more chemical features or the chemical information includes at least one of potassium information or creatinine information of the patient (Averina: para. 59).
As per claim 12, the system of claim 1 is as described. Averina teaches wherein the assessment circuit is configured to provide an output of the generated composite health index alert to a user interface for display to a user or to a control circuit to control or adjust a process or function of the medical device system (Averina: para. 75).
Claims 13-14 recite substantially similar limitations as those already addressed in claims 1-2, and, as such, are rejected for similar reasons as given above.
As per claim 13, the method of claim 13 is as described. Averina teaches wherein the one or more chemical features comprise one or more indications of relative high or low values of the received chemical information with respect to one or more chemical feature thresholds (Averina: para. 42; Thresholds for physiological signals, which also includes chemical signals.),
-wherein the method comprises determining, using the assessment circuit: the one or more chemical feature thresholds as a function of the received chemical information over a first time period (Averina: para. 68-69; Trend of the signal is compared to the threshold.); and
-the indication of relative high or low values of the received chemical information by comparing a value of the received chemical information to the determined one or more chemical feature thresholds (Averina: para. 68-69; Indicate the predictor trend based on the temporal changes based on thresholds.).
Claims 16-20 recite substantially similar limitations as those already addressed in claims 5-9, and, as such, are rejected for similar reasons as given above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
An et al. – U.S. Publication No. 2017/0281095 – Teaches a system and method for receiving diagnostic data and producing risk indication.
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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3681