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 .
Notice to Applicant
This communication is in response to the amendment filed 7/7/2026. Claims 1, 15, and 17 have been amended. Claims 1-20 remain pending and have been examined.
Response to Arguments
A. Applicant’s arguments with respect to the rejection of claims 1-20 under 35 USC 101 have been fully considered but are not persuasive.
Applicant argues starting on page 8 of the response that elements are directed to an improvement to medical device operation on the basis that the elements reciting “an assessment circuit configured to determine that a sensed physiologic feature becomes not valid after a previous period in which the feature was determined to be valid, to adjust the function used to determine the composite health index to improve sensitivity or specificity, and to control transition between lower-resource and higher-resource modes based on the determined composite health index to improve resource utilization of the medical device system,” as an ordered combination, are a “practical technological application.” Examiner respectfully disagrees.
As noted below, the determination that a sensed physiologic feature becomes not valid after a previous period in which the feature was determined to be valid, and adjusting the function used to determine the composite health index to improve sensitivity or specificity fall within the scope of the abstract idea. The further recitation of adjust the function used to determine the composite health index to improve sensitivity or specificity, and to control transition between lower-resource and higher-resource modes based on the determined composite health index only amounts to insignificant extra-solution activity and well-understood routine and conventional activity on the bases set out in Step 2A Prong 2 and Step 2B. While the specification discloses advantages of switching between higher-power modes and lower-power modes in the context of implantable medical devices, Examiner disagrees with Applicant’s assertion that the specification describes controlling these transitions using the calculated composite health index. Additionally, Examiner notes that the claims only recite the “medical device” being controlled is only recited at a high level of generality and encompasses any form of medical device the modes as a “lower-resource” mode and a “higher-resource” mode without further specification of what such resources encompass or what constitutes lower vs higher, and the actual basis on which this is performed is also recited broadly as “based on” the determined composite health index without further limitation on how the composite health index is actually used or involved in the control. Given this, Examiner maintains that these elements do not satisfy the requirements for application of the judicial exception with or by use of a particular machine. See MPEP 2106.05(b).
The rejection under 35 USC 101 is maintained.
B. Applicant’s arguments with respect to the rejection under 35 USC 102 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 as valid or not valid after a previous period in which the first feature was determined to be valid, and in response to a determination that the first feature of the at least two of the plurality of features is not valid, adjusting the function used to determine the composite health index to improve a sensitivity or specificity of 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) a medical device used to sense the physiologic information, c) 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.
Paragraph 42 states that “Ambulatory medical devices can include, or be configured to receive physiologic information from, one or more sensors located within, on, or proximate to a body of a patient.” Paragraph 52 states that “Implantable and ambulatory medical devices frequently contain one or more accelerometer sensors and corresponding processing circuits to determine and monitor patient acceleration information, such as, among other things, cardiac vibration information associated with blood flow or movement in the heart or patient vasculature (e.g., heart sounds, cardiac wall motion, etc.), patient physical activity or position information (e.g., patient posture, activity, etc.), respiration information (e.g., respiration rate, phase, breathing sounds, etc.).” Paragraph 56 further provides that the activity information can including activity measurements of the patient detected using elements such as an accelerometer or other activity sensors within an ambulatory medical device. The medical device is construed as encompassing generic forms of ambulatory medical devices.
The above elements 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. The medical device is similarly only recited at a high level of generality as used to sense the physiologic information of the patient. 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 additional elements of a) receiving the physiologic information, and b) controlling transition of the medical device or the medical device system between a lower-resource mode and a higher-resource mode based on the determined composite health index to improve resource utilization of the medical device system.
However, receiving the physiologic information only amounts to necessary data gathering for use as part of the abstract idea, and therefore constitutes insignificant extra-solution activity.
Controlling transition of the medical device or the medical device system between a lower-resource mode and a higher-resource mode based on the determined composite health index to improve resource utilization of the medical device system only amounts to insignificant extra-solution activity on the basis that it is only nominally or tangentially related to the invention, i.e. determining a composite health index for the patient as a function of at least two of a plurality of features from physiologic information of a patient, and adjusting the function used to determine the composite health index based on a determination that a first feature used to determine the index is not valid.
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, medical device, 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 the additional elements of a) receiving the physiologic information, and b) controlling transition of the medical device or the medical device system between a lower-resource mode and a higher-resource mode based on the determined composite health index to improve resource utilization of the medical device system. However, these elements only amount insignificant extra-solution activity as set out above.
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.
Likewise, controlling transition of a medical device between a lower-resource mode and a higher-resource mode based on a determined composite health index to improve resource utilization of the medical device system only amounts to well-understood routine and conventional activity. Initially, Examiner notes that the “medical device” being controlled is only recited at a high level of generality and encompasses any form of medical device. Similarly, the claim only recites the modes as a “lower-resource” mode and a “higher-resource” mode without further specification of what such resources encompass or what constitutes lower vs higher. The actual basis on which this is performed is also recited broadly as “based on” the determined composite health index without further limitation on how the composite health index is actually used or involved in the control. Examiner notes that one of the factors considered with respect to whether a judicial exception is applied with, or by use of, a particular machine is the particularity or generality of the elements of the machine or apparatus. See MPEP 2106.05(b).
In view of the above, Examiner further notes that controlling the transition of a medical device between high and low resource modes is extensively taught in the prior art of record. For example, this functionality is taught by Cho et al (2022/0369937)(see e.g. paragraphs 6, 31, 84, 85, 90, and 93) as cited below, as well as Huelskamp et al (2019/0099605)(see e.g. Abstract, Figure 11, and paragraphs 5, 58, and 60), Chung et al (2015/0106020)(see e.g. paragraphs 71, 78-80, and 96), and Husheer et al (2018/0049653)(see e.g. Abstract and paragraphs 7-9, 15, and 89).
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 1-20 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
With regard to claims 1 and 17, the newly added recitation of "control transition of the medical device or the medical device system between a lower-resource mode and a higher-resource mode based on the determined composite health index to improve resource utilization of the medical device system" appears to constitute new matter. Paragraphs 73 through 75 describe medical devices having higher-resource modes and lower-resource modes, and that physiologic information can be used to transition from a low-power mode to a high-power mode. However, while the specification provides this description of using physiological information to transition between modes, the disclosure does not appear to describe controlling transition of the medical device or the medical device system between a lower-resource mode and a higher-resource mode based on the determined composite health index. Examiner notes that claims 1 and 17 recite the composite health index as determined as a function of at least two of a plurality of features included in physiological information, i.e. the composite health index is not recited simply as the value of a physiological measurement.
Claims 2-16 and 18-20 inherit the deficiencies of claims 1 and 17 through dependency and are likewise rejected.
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, 16, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cho et al (US Patent Application Publication 2022/0369937).
With respect to claim 1, Cho discloses the claimed medical device system, comprising:
a signal receiver circuit configured to receive physiologic information of a patient sensed by a medical device, the physiologic information including a plurality of features (Figure 2, [20]-[23], [29], and [49] describe an IMD configured to measure a plurality of patient physiological parameters); 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 ([50], [82], [84], and [86] describe applying a first set of rules to the first set of physiological parameters to determine a risk score, i.e. a composite health index), including to:
determine validity of a first feature of the at least two of the plurality of features as valid or not valid after a previous period in which the first feature was determined to be valid ([85] and [87] describe determining that the noise level of at least one parameter affects the confidence in the risk determination, i.e. the parameter is invalid; [91] describes determining that a particular parameter contradicts a risk determination, i.e. the parameter is invalid. Examiner notes paragraph 103 of Applicant’s specification as originally filed which lists a contradictory parameter among reasons for invalidity); 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 to improve a sensitivity or specificity of the composite health index ([83]-[87] and [90]-[93] describe applying a second set of rules and/or parameters for determining the health status of the user if the change in rules or data is determined useful to clarify the first determination);
wherein the assessment circuit is configured to control transition of the medical device or the medical device system between a lower-resource mode and a higher-resource mode based on the determined composite health index to improve resource utilization of the medical device system ([6], [31], [84], [85], [90], and [93] describe transitioning the IMD to a more power-intensive set of second rules and/or sensors based on the physiological data and risk information).
With respect to claim 16, Cho discloses the claimed medical device system of claim 1. Cho further discloses:
wherein the composite health index includes a composite heart failure index ([29] and [84] describe the acute health event including sudden cardiac arrest and signs of cardiac failure, i.e. the composite risk of such events being a heart failure index).
With respect to claim 17, Cho discloses the claimed method, comprising:
receiving, using a signal receiver circuit, physiologic information of a patient sensed by a medical device, the physiologic information including a plurality of features (Figure 2, [20]-[23], [29], and [49] describe an IMD configured to measure a plurality of patient physiological parameters); 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 ([50], [82], [84], and [86] describe applying a first set of rules to the first set of physiological parameters to determine a risk score, i.e. a composite health index), including:
determining validity of a first feature of the at least two of the plurality of features as valid or not valid after a previous period in which the first feature was determined to be valid ([85] and [87] describe determining that the noise level of at least one parameter affects the confidence in the risk determination, i.e. the parameter is invalid; [91] describes determining that a particular parameter contradicts a risk determination, i.e. the parameter is invalid. Examiner notes paragraph 103 of Applicant’s specification as originally filed which lists a contradictory parameter among reasons for invalidity); and
adjusting the function used to determine the composite health index to improve a sensitivity or specificity of 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 ([83]-[87] and [90]-[93] describe applying a second set of rules and/or parameters for determining the health status of the user if the change in rules or data is determined useful to clarify the first determination);
controlling transition of the medical device or the medical device system between a lower-resource mode and a higher-resource mode based on the determined composite health index to improve resource utilization of the medical device system ([6], [31], [84], [85], [90], and [93] describe transitioning the IMD to a more power-intensive set of second rules and/or sensors based on the physiological data and risk information).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 5, 6, 13, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al (US Patent Application Publication 2022/0369937) as applied to claims 1 and 17 above, and further in view of Yamazaki et al (US Patent Application Publication 2022/0108801).
With respect to claim 2, Cho discloses the medical device system of claim 1. Cho further discloses:
wherein to adjust the function used to determine the composite health index comprises including a second feature of the plurality of features in response to the determination that the first feature is not valid ([88] and [90]-[92] describe the second set of parameters including a parameter not included in the first set), wherein the second feature is correlative to the first feature ([91] describes the second feature being parallel to the first rather than orthogonal);
but does not expressly disclose:
substituting the second feature of the plurality of features for the first feature in response to the determination that the first feature is not valid.
However, Yamazaki teaches that it was old and well known in the art of patient monitoring before the effective filing date of the claimed invention to substitute a second feature of a plurality of features for a first feature in response to a 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).
Therefore it would have been obvious to one of ordinary skill in the art of patient monitoring before the effective filing date of the claimed invention to modify the system of Cho 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 as taught by Yamazaki since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Cho already discloses adding a second feature, and substituting the second feature as taught by Yamazaki would serve that same function in Cho, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 5, Cho/Yamazaki teach the medical device system of claim 2. Cho 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 ([88] and [90]-[92] describe the second set of parameters including multiple parameters not included in the first set);
but does not expressly disclose:
determining 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 selecting the second feature based on the determined correlations.
However, Yamazaki teaches that it was old and well known in the art of patient monitoring before the effective filing date of the claimed invention to determine a correlation between a first feature and 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).
Therefore it would have been obvious to one of ordinary skill in the art of patient monitoring before the effective filing date of the claimed invention to modify the combination of Cho and Yamazaki to determine a correlation between a first feature and 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 as taught by Yamazaki since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Cho and Yamazaki already teach the two or more additional features as well as adding a second feature, and doing so based on a determination that the second feature is correlated with the two or more additional features as taught by Yamazaki would serve that same function in Cho and Yamazaki, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 6, Cho/Yamazaki teach the medical device system of claim 5. Cho 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 ([88] and [90]-[92] describe the second set of parameters including multiple parameters not included in the first set).
With respect to claim 13, Cho discloses the medical device system of claim 1. Cho does not expressly disclose 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.
However, Yamazaki teaches that it was old and well known in the art of patient monitoring before the effective filing date of the claimed invention to adjust the function used to determine the composite health index by using a representation of a 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).
Therefore it would have been obvious to one of ordinary skill in the art of patient monitoring before the effective filing date of the claimed invention to modify the combination of Cho and Yamazaki to adjust the function used to determine the composite health index by using a representation of a first feature based on a third time period in response to the determination that the first feature is not valid as taught by Yamazaki since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Cho and Yamazaki already teach the adjusting the function used to determine the composite health index, and doing so using a representation of a first feature based on a third time period in response to the determination that the first feature is not valid as taught by Yamazaki would serve that same function in Cho and Yamazaki, making the results predictable to one of ordinary skill in the art (MPEP 2143).
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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Gregory Lultschik/Examiner, Art Unit 3682
Prosecution Insights