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 1-20 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. Claims 1-16 are drawn to a system, and claims 17-20 are drawn to a method, each of which is within the four statutory categories.
Step 2A(1)
Claim 1 recites, in part, performing the steps of:
determining, using physiologic information of a patient including a plurality of features, a composite health index for the patient as a function of at least two of the plurality of features, including determining validity of a first feature of the at least two of the plurality of features and in response to a determination that the first feature of the at least two of the plurality of features is not valid, adjust the function used to determine the composite health index.
These elements amount to concepts performed in the human mind, and therefore fall within the scope of an abstract idea in the form of a mental process. Fundamentally the process is that of a) determining a composite health index for the patient as a function of at least two of a plurality of features included in a set of physiologic information of a patient, and b) adjusting the function used to determine the composite health index based on a determination that a first feature of the at least two of the plurality of features is not valid. These elements constitute a process of observing and evaluating patient physiologic information to determine a metric of the patient’s health, and reevaluating how the information should be used to determine the metric if part of the information being used is judged to be invalid. A clinician could perform each of these steps mentally as part of assessing a patient’s health based on the information available about the patient.
Independent claim 17 recites similar limitations and also recite an abstract idea under the same analysis.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claims 1 and 17 recite additional elements of a) a signal receiver circuit recited as configured to perform the function of receiving the physiologic information of the patient, and b) an assessment circuit recited as configured to perform the function of determining the composite health index.
Paragraph 127 of Applicant’s specification as filed states that “[c]ircuitry (e.g., processing circuitry, an assessment circuit, etc.) is a collection of circuits implemented in tangible entities of the machine 500 that include hardware (e.g., simple circuits, gates, logic, etc.), ” while paragraph 128 further provides that “machine 500 may operate in the capacity of a server machine, a client machine, or both in server-client network environments,” and “may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine.” Paragraph 129 additionally states that “machine 500 (e.g., computer system) may include a hardware processor 502 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof)…”. The signal receiver circuit and assessment circuit are construed accordingly as encompassing generic computing elements.
The recited signal receiver circuit and assessment circuit only amount to mere instructions to implement functions within the abstract idea using computing elements as tools. Each of the signal receiver circuit and assessment circuit are recited at a high level of generality as “configured to” perform their respective data processing functions, and are disclosed broadly as including generic forms of computer processing devices. These elements are therefore not sufficient to integrate the abstract idea into a practical application.
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Claims 1 and 17 further recite an additional element of receiving the physiologic information. However, this element only amounts to necessary data gathering for use as part of the abstract idea, and therefore constitutes insignificant extra-solution activity.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1 and 17 only recite the signal receiver circuit and assessment circuit as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f)
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
As addressed above, claims 1 and 17 further recite an additional element of receiving the physiologic information. However, this element only amounts to necessary data gathering for use as part of the abstract idea, and therefore constitutes insignificant extra-solution activity.
C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d)
In addition to constituting insignificant extra-solution activity, the element of receiving the physiologic information amounts to well-understood routine and conventional activity in the form of receiving or transmitting data and/or retrieving information from memory.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claims 2 and 18 recite wherein adjusting the function used to determine the composite health index comprises substituting a second feature of the plurality of features for the first feature in response to the determination that the first feature is not valid, wherein the second feature is correlative to the first feature. These limitations fall within the scope of the abstract idea as set out above.
Claim 3 recites determining a correlation between the first feature and the second feature, and to determine that the second feature is correlative to the first feature if a determined correlation between the first feature and the second feature over a first time period preceding the determination that the first feature is not valid exceeds a threshold correlation. These limitations fall within the scope of the abstract idea as set out above.
Claim 3 further recites the additional element of the assessment circuit as being configured to perform the subsequent correlating functions.
Paragraph 127 of Applicant’s specification as filed states that “[c]ircuitry (e.g., processing circuitry, an assessment circuit, etc.) is a collection of circuits implemented in tangible entities of the machine 500 that include hardware (e.g., simple circuits, gates, logic, etc.), ” while paragraph 128 further provides that “machine 500 may operate in the capacity of a server machine, a client machine, or both in server-client network environments,” and “may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine.” Paragraph 129 additionally states that “machine 500 (e.g., computer system) may include a hardware processor 502 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof)…”. The assessment circuit is construed accordingly as encompassing generic computing elements.
The recited assessment circuit only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. The assessment circuit is recited at a high level of generality as “configured to” perform its corresponding data processing functions, and is disclosed broadly as including generic forms of computer processing devices. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 4 recites wherein the first time period preceding the determination that the first feature is not valid is between 3 days and 31 days. These limitations fall within the scope of the abstract idea as set out above.
Claim 5 recites selecting the second feature from two or more additional features of the plurality of features separate from the first feature, including to: determine a correlation between the first feature and the two or more additional features over a first time period preceding the determination that the first feature is not valid; and select the second feature based on the determined correlations. These limitations fall within the scope of the abstract idea as set out above.
Claim 5 further recites the additional element of the assessment circuit as being configured to select the second feature and perform the subsequent correlating functions.
Paragraph 127 of Applicant’s specification as filed states that “[c]ircuitry (e.g., processing circuitry, an assessment circuit, etc.) is a collection of circuits implemented in tangible entities of the machine 500 that include hardware (e.g., simple circuits, gates, logic, etc.), ” while paragraph 128 further provides that “machine 500 may operate in the capacity of a server machine, a client machine, or both in server-client network environments,” and “may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine.” Paragraph 129 additionally states that “machine 500 (e.g., computer system) may include a hardware processor 502 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof)…”. The assessment circuit is construed accordingly as encompassing generic computing elements.
The recited assessment circuit only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. The assessment circuit is recited at a high level of generality as “configured to” perform its corresponding data processing functions, and is disclosed broadly as including generic forms of computer processing devices. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 6 recites wherein the function to determine the composite health index of the patient does not include the two or more additional features when the first feature is valid. These limitations fall within the scope of the abstract idea as set out above.
Claim 7 recites wherein to substitute the second feature of the plurality of features for the first feature in response to the determination that the first feature is not valid comprises to assign a weight for the second feature in the function corresponding to a weight of the first feature before the determination that the first feature is not valid. These limitations fall within the scope of the abstract idea as set out above.
Claim 8 recites wherein to adjust the function used to determine the composite health index comprises to use a last valid value of the first feature for a second time period including a first number of days after the determination that the first feature is not valid, and thereafter, to substitute the second feature for the first feature. These limitations fall within the scope of the abstract idea as set out above.
Claims 9 and 19 recite wherein to adjust the function used to determine the composite health index comprises to remove the first feature from the function and to adjust a weight of a valid one of the at least two of the plurality of features in the function in response to the determination that the first feature is not valid. These limitations fall within the scope of the abstract idea as set out above.
Claim 10 recites wherein to adjust the weight of the valid one of the at least two of the plurality of features comprises to maintain relative weight of remaining valid features of the at least two of the plurality of features in the function. These limitations fall within the scope of the abstract idea as set out above.
Claim 11 recites wherein to adjust the weight of the valid one of the at least two of the plurality of features comprises to increase the weight over a first specified number of days from a previous weight from before the determination that the first feature is not valid to a target weight higher than the previous weight. These limitations fall within the scope of the abstract idea as set out above.
Claim 12 recites wherein to adjust the weight of the valid one of the at least two of the plurality of features comprises to keep the weight constant for a second specified number of days after the determination that the first feature is not valid before increasing the weight. These limitations fall within the scope of the abstract idea as set out above.
Claims 13 and 20 recite wherein to adjust the function used to determine the composite health index comprises to use a representation of the first feature based on a third time period in response to the determination that the first feature is not valid. These limitations fall within the scope of the abstract idea as set out above.
Claim 14 recites wherein to adjust the function used to determine the composite health index comprises to decrease a weight of the representation of the first feature over time and to increase a weight of remaining valid features of the at least two of the plurality of features commensurate with the decreased weight of the representation of the first feature over time. These limitations fall within the scope of the abstract idea as set out above.
Claim 15 recites wherein, in response to the determination that the first feature is not valid, determining one of a physiologic or a non-physiologic reason for the determination, and wherein to adjust the function used to determine the composite health index includes using a first adjustment in response to a determined physiologic reason and using a second adjustment in response to a determined non-physiologic reason, wherein the first adjustment is different than the second adjustment. These limitations fall within the scope of the abstract idea as set out above.
Claim 15 further recites the additional element of the assessment circuit as being configured to determine one of a physiologic or a non-physiologic reason for the determination.
Paragraph 127 of Applicant’s specification as filed states that “[c]ircuitry (e.g., processing circuitry, an assessment circuit, etc.) is a collection of circuits implemented in tangible entities of the machine 500 that include hardware (e.g., simple circuits, gates, logic, etc.), ” while paragraph 128 further provides that “machine 500 may operate in the capacity of a server machine, a client machine, or both in server-client network environments,” and “may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine.” Paragraph 129 additionally states that “machine 500 (e.g., computer system) may include a hardware processor 502 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof)…”. The assessment circuit is construed accordingly as encompassing generic computing elements.
The recited assessment circuit only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. The assessment circuit is recited at a high level of generality as “configured to” perform its corresponding data processing functions, and is disclosed broadly as including generic forms of computer processing devices. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 16 recites wherein the composite health index includes a composite heart failure index. These limitations fall within the scope of the abstract idea as set out above.
Claims 1-18 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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)(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, 2, 5, 6, 13, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yamazaki et al (US Patent Application Publication 2022/0108801).
With respect to claim 1, Yamazaki discloses the claimed medical device system, comprising:
a signal receiver circuit configured to receive physiologic information of a patient, the physiologic information including a plurality of features (Figure 4, [28], [29], [34], [56], and [152] describe the computer system receiving a plurality of examination items comprising patient physiological data types); and
an assessment circuit configured to determine a composite health index for the patient as a function of at least two of the plurality of features (Figure 14, [33], [117], [121], and [137] describe determining a risk value for a disease based on a plurality of examination items), including to:
determine validity of a first feature of the at least two of the plurality of features ([93], [114], [117], and [154] describe determining whether any of the required examination items are missing); and
in response to a determination that the first feature of the at least two of the plurality of features is not valid, adjust the function used to determine the composite health index (Figure 7, [93], [99], [114], [115], [117], [130], and [154]-[156] describe, in a situation where a required examination item is missing, using different examination items to calculate a value which is then inputted into the model. Examiner notes that the broadest reasonable interpretation of the “function” in the context of the index being “a function of at least two of the plurality of features” encompasses all of the steps used to generate the index from the features. The addition of calculating a missing value using other factors is construed as adjusting the function by which the index is determined).
With respect to claim 2, Yamazaki discloses the medical device system of claim 1. Yamazaki further discloses:
wherein to adjust the function used to determine the composite health index comprises substituting a second feature of the plurality of features for the first feature in response to the determination that the first feature is not valid (Figure 7, [93], [99], [114], [115], [117], [130], and [154]-[156] describe, in a situation where a required examination item is missing, using different examination items to calculate a value which is then inputted into the model, i.e. the examination items used to calculate the value are substituted for the missing feature), wherein the second feature is correlative to the first feature (Figure 15, [55], [89], and [149] state that the conversion functions are based on correlations between the input and output examination items).
With respect to claim 5, Yamazaki discloses the medical device system of claim 2. Yamazaki further discloses:
wherein the assessment circuit is configured to select the second feature from two or more additional features of the plurality of features separate from the first feature (Figures 7-9, [93], [99], and [114] describe selecting a conversion function from a plurality of different conversion functions corresponding to two or more additional examination items), including to:
determine a correlation between the first feature and the two or more additional features over a first time period preceding the determination that the first feature is not valid; and select the second feature based on the determined correlations (Figures 7-9, [62], [63], [73], and [100] describe storing a precision value for each conversion function corresponding to a probable error between the actual examination value to be calculated and the value derived from the conversion function, and selecting the conversion function, i.e. selecting the corresponding feature, based on the precision).
With respect to claim 6, Yamazaki discloses the medical device system of claim 5. Yamazaki further discloses:
wherein the function to determine the composite health index of the patient does not include the two or more additional features when the first feature is valid (Figure 11 and [116]-[118] provide an example where the function normally uses blood pressure and CTR as input examination items, but will use the examination item of ‘image information’ in place of CTR if no CTR data is available).
With respect to claim 13, Yamazaki discloses the medical device system of claim 1. Yamazaki further discloses:
wherein to adjust the function used to determine the composite health index comprises to use a representation of the first feature based on a third time period in response to the determination that the first feature is not valid (Figure 7, [93], [99], [114], [115], [117], [130], and [154]-[156] describe, in a situation where a required examination item is missing, using different examination items to calculate a value representing the required examination item, which is then inputted into the model; [53]-[55] and [66]-[70] describe the conversion functions being calculated based on data over a range of previous dates, i.e. a third time period).
With respect to claim 16, Yamazaki discloses the claimed medical device system of claim 1. Yamazaki further discloses:
wherein the composite health index includes a composite heart failure index (Figures 12 and 14, [123]).
With respect to claim 17, Yamazaki discloses the claimed method, comprising:
receiving, using a signal receiver circuit, physiologic information of a patient, the physiologic information including a plurality of features (Figure 4, [28], [29], [34], [56], and [152] describe the computer system receiving a plurality of examination items comprising patient physiological data types); and
determining, using an assessment circuit, a composite health index for the patient as a function of at least two of the plurality of features (Figure 14, [33], [117], [121], and [137] describe determining a risk value for a disease based on a plurality of examination items), including:
determining validity of a first feature of the at least two of the plurality of features ([93], [114], [117], and [154] describe determining whether any of the required examination items are missing); and
adjusting the function used to determine the composite health index in response to determining that the first feature of the at least two of the plurality of features is not valid ([93], [99], [114], [115], [117], [130], and [154]-[156] describe, in a situation where a required examination item is missing, using different examination items to calculate a value which is then inputted into the model. Examiner notes that the broadest reasonable interpretation of the “function” in the context of the index being “a function of at least two of the plurality of features” encompasses all of the steps used to generate the index from the features. The addition of calculating a missing value using other factors is construed as adjusting the function by which the index is determined).
Claim 18 recites limitations similar to those recited in claim 2, and is rejected on the same grounds set out above with respect to claim 2.
Claim 20 recites limitations similar to those recited in claim 13, and is rejected on the same grounds set out above with respect to claim 13.
Claims Not Rejected under 35 USC 102/103
Claims 3, 4, 7-12, 14, 15, and 19 are not presently rejected under the closest prior art of record cited herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Morris et al (US Patent Application Publication 2011/0105852);
Aoyagi (US Patent Application Publication 2019/0214138);
Du et al (US Patent Application Publication 2017/0027524);
Meyer et al (US Patent Application Publication 2019/0378619);
Jiang et al, A Patient-Driven Adaptive Prediction Technique to Improve Personalized Risk Estimation for Clinical Decision Support.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM G LULTSCHIK whose telephone number is (571)272-3780. The examiner can normally be reached 9am - 5pm.
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, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Gregory Lultschik/Examiner, Art Unit 3682
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