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
Claim 18 is cancelled.
Claims 1 and 19 are amended.
Claims 1-19 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 1-17 and 19 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 machine (claims 1-17) and article of manufacture (claim 19). Accordingly, claims 1-17 and 19 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 risk calculation apparatus configured to calculate a risk related to a health status of a patient, the risk calculation apparatus comprising:
-thermometer configured to continuously obtain a body temperature and patient condition information of the patient; and
-at least one processor and memory collectively configured to:
-compare the obtained body temperature with a reference temperature;
-correct the body temperature based on the patient condition information when comparing the body temperature with the reference temperature, set the reference temperature based on the patient condition information when comparing the body temperature with the reference temperature, or increase or decrease the comparison result based on the patient condition information; and
-continuously output the risk related to the health status of the patient based on the corrected body temperature,
-wherein the risk is a prediction that the patient will become ill after a predetermined period of time.
Examiner states submits that the foregoing underlined limitations constitute: a “mental process” because gathering body temperature and condition information to compare it to reference values and determining risk can all be performed in the human mind.
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 risk calculation apparatus (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 56-57) configured to calculate a risk related to a health status of a patient, the risk calculation apparatus comprising:
-thermometer configured to continuously obtain a body temperature and patient condition information of the patient (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 58); and
-at least one processor and memory (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 56) collectively configured to:
-obtain a body temperature and patient condition information of the patient; and
-compare the obtained body temperature with a reference temperature;
-correct the body temperature based on the patient condition information when comparing the body temperature with the reference temperature, set the reference temperature based on the patient condition information when comparing the body temperature with the reference temperature, or increase or decrease the comparison result based on the patient condition information; and
-continuously output the risk related to the health status of the patient based on the corrected body temperature,
-wherein the risk is a prediction that the patient will become ill after a predetermined period of time.
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 19 and analogous independent claim
1 do not recite additional elements that integrate the judicial exception into a practical
application. Accordingly, representative independent claim 19 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 2-4, 8-9, 11-12, 16-17: The claim specifies patient condition and processor configured to correct body temperature, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 5: The claim specifies the processor continuously obtaining patient condition and correcting body temperature, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 6-7, 10, 14-15: The claim specifies patient condition and the processor correcting body temperature, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 13: The claim specifies medication information, which further narrows the abstract idea.
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 19 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 obtain body temperature and patient condition, output risk, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)).
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 2-12 and 14-17, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 2-12 and 14-17 (correct body temperature, set reference temperature), e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv)). 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 1-17 and 19
are nonetheless 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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 19 recite the limitation “continuously output the risk related to the health status,” and “continuously determining the risk related to the health status.” Examiner states that continuously outputting the risk is what? How can risk be continuously outputted or is it whenever the temperature changes, the risk is also updated. What are the metes and bounds of continuously outputting risk? For examination purposes, Examiner interprets the limitation to mean that the risk is outputted when the temperatures are analyzed. Examiner asks the Applicant to clarify.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ellis et al. (WO 2018/033799) in view of Gannon et al. (U.S. Publication No. 2021/0100454).
As per claim 1, Ellis teaches a risk calculation apparatus configured to calculate a risk related to a health status of a patient, the risk calculation apparatus comprising:
-a thermometer configured to continuously obtain a body temperature and patient condition information of the patient (Ellis: para. 17; para. 19; temperature sensors continuously taking measurements.);
-at least one processor and memory collectively configured to (Ellis: para. 18; para. 95):
-obtain a body temperature and patient condition information of the patient (Ellis: para. 14; para. 25; para. 65; para. 86; Collect temperature data from a set of temperature sensors and other physiological metrics.); and
-compare the obtained body temperature with a reference temperature (Ellis: para. 92);
-correct the body temperature based on the patient condition information when comparing the body temperature with the reference temperature, set the reference temperature based on the patient condition information when comparing the body temperature with the reference temperature, or increase or decrease the comparison result based on the patient condition information (Ellis: para. 88; para. 92; Modify core body temperature depending on other metrics. Performing temperature correction based on reference profiles, which are generated on individual basis. Characterize user condition based on core body temperature measurements and the user condition model.); and
-continuously output the risk related to the health status of the patient based on the corrected body temperature (Ellis: para. 86; Characterize the user’s risk of condition.).
Ellis does not explicitly teach the following, however, Gannon teaches: wherein the risk is a prediction that the patient will become ill after a predetermined period of time (Gannon: para. 41; Fever prediction based on continuous temperature input and determining prediction of a fever.).
One of ordinary skill in the art would have recognized that applying the known technique of Gannon would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Gannon to the teachings of Ellis would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such features into similar systems. Further, applying prediction of risk to Ellis teaching characterization of user’s physiological measurements would have been recognized by those of ordinary skill in the art as resulting in an improved system that would provide a system that can efficiently manage user’s conditions and provide faster treatments (Gannon: para. 3-4).
As per claim 2, the apparatus of claim 1 is as described. Ellis further teaches:
-wherein the patient condition information varies according to a circadian rhythm in the body temperature the patient (Ellis: para. 29-30; para. 88; Filter temperature data based on contextual data. Temperature data stored in association with circadian rhythm.), and
-wherein the processor is configured to, based on the variation according to the circadian rhythm, correct the body temperature, sets the reference temperature, or increases or decreases the comparison result (Ellis: para. 88; Modify core temperature based on parameters, including medication.).
As per claim 3, the apparatus of claim 2 is as described. Ellis further teaches wherein the processor is configured to correct the body temperature, set the reference temperature, or increase or decrease the comparison result in a manner that offsets the variation according to the circadian rhythm (Ellis: para. 88; Modify core body temperature depending on other metrics. Performing temperature correction based on reference profiles, which are generated on individual basis.).
As per claim 4, the apparatus of claim 2 is as described. Ellis further teaches wherein the processor is configured to correct the body temperature, set the reference temperature, or increase or decrease the comparison result such that the body temperature, the reference temperature, or the comparison result follows the variation due to the circadian rhythm (Ellis: para. 88; Modify core body temperature depending on other metrics. Performing temperature correction based on reference profiles, which are generated on individual basis.).
As per claim 5, the apparatus of claim 2 is as described. Ellis further teaches:
-wherein the processor is configured to continuously obtain the patient condition information (Ellis: para. 29; para. 88; Sample temperature data continuously.), and
-wherein the processor is configured to, based on a time when the body temperature of the patient is obtained, correct the body temperature, set the reference temperature, or increase or decrease the comparison result (Ellis: para. 88; Modify core body temperature depending on other metrics, including time of day. Performing temperature correction based on reference profiles, which are generated on individual basis.).
As per claim 6, the apparatus of claim 2 is as described. Ellis further teaches:
-wherein the patient condition information includes activity information indicating whether the patient is currently asleep or awake (Ellis: para. 29; para. 88; Filter temperature data based on contextual data.), and
-wherein the processor is configured to, based on the activity information, correct the body temperature, set the reference temperature, or increase or decrease the comparison result (Ellis: para. 88; Modify core temperature based on parameters, including fitness.).
As per claim 7, the apparatus of claim 1 is as described. Ellis further teaches
-wherein the patient condition information includes a basal metabolic rate of the patient or information for calculating the basal metabolic rate of the patient (Ellis: para. 29; Filter temperature data based on contextual data.), and
-wherein the processor is configured to, based on the basal metabolic rate of the patient and a standard basal metabolism, correct the body temperature, set the reference temperature, or increase or decrease the comparison result (Ellis: para. 88; Modify core body temperature depending on other metrics, including dietary behavior. Performing temperature correction based on reference profiles, which are generated on individual basis.).
As per claim 8, the apparatus of claim 7 is as described. Ellis further teaches wherein the processor is configured to correct the body temperature, set the reference temperature, or increase or decrease the comparison result in a manner that offsets an increase or decrease in the basal metabolic rate of the patient from the standard basal metabolism (Ellis: para. 88; Modify core body temperature depending on other metrics. Performing temperature correction based on reference profiles, which are generated on individual basis.).
As per claim 9, the apparatus of claim 7 is as described. Ellis further teaches wherein the processor is configured to correct the body temperature, set the reference temperature, or increase or decrease the comparison result such that the body temperature, the reference temperature, or the comparison result follows an increase or decrease in the basal metabolic rate of the patient from the standard basal metabolism (Ellis: para. 88; Modify core body temperature depending on other metrics. Performing temperature correction based on reference profiles, which are generated on individual basis.).
As per claim 10, the apparatus of claim 1 is as described. Ellis further teaches:
-wherein the patient condition information includes medication information indicating a drug administered to the patient (Ellis: para. 88), and
-wherein the processor is configured to, based on the medication information, correct the body temperature, set the reference temperature, or increase or decrease the comparison result (Ellis: para. 88; Modify core temperature based on parameters, including medication.).
As per claim 11, the apparatus of claim 10 is as described. Ellis further teaches wherein the processor is configured to correct the body temperature, set the reference temperature, or increase or decrease the comparison result in a manner that offsets an increase or decrease in the body temperature of the patient caused by the drug (Ellis: para. 88; Modify core body temperature depending on other metrics. Performing temperature correction based on reference profiles, which are generated on individual basis.).
As per claim 12, the apparatus of claim 10 is as described. Ellis further teaches wherein the processor is configured to correct the body temperature, set the reference temperature, or increase or decrease the comparison result such that the body temperature, the reference temperature, or the comparison result follows an increase or decrease in the body temperature of the patient caused by the drug (Ellis: para. 88; Modify core body temperature depending on other metrics. Performing temperature correction based on reference profiles, which are generated on individual basis.).
As per claim 13, the apparatus of claim 10 is as described. Ellis further teaches wherein the medication information includes a type of the drug, elapsed time after the drug is administered, or an administration method of the drug (Ellis: para. 88; Accounting for type of drug consumed.).
As per claim 14, the apparatus of claim 1 is as described. Ellis further teaches:
-wherein the patient condition information includes a result of a diagnosis of a disease of the patient (Ellis: para. 16), and
-wherein the processor is configured to, based on the result of diagnosis, correct the body temperature, set the reference temperature, or increase or decrease the comparison result (Ellis: para. 88).
As per claim 15, the apparatus of claim 1 is as described. Ellis further teaches:
-wherein the patient condition information includes a pulse of the patient (Ellis: para. 69; Physiological metrics including pulse metrics.), and
-wherein the processor is configured to:
-determine relative bradycardia based on the pulse (Ellis: para. 69; cardiovascular parameters.), and
-based on the relative bradycardia, correct the body temperature, set the reference temperature, or increase or decrease the comparison result (Ellis: para. 88; physiological metrics used to modify core body temperature.).
As per claim 16, the apparatus of claim 15 is as described. Ellis further teaches wherein processor is configured to correct the body temperature, set the reference temperature, or increase or decrease the comparison result such that the body temperature, the reference temperature, or the comparison result follows a difference between a first body temperature increase actually measured and a second body temperature increase estimated based on the pulse (Ellis: para. 88; Modify core body temperature depending on other metrics. Performing temperature correction based on reference profiles, which are generated on individual basis.).
As per claim 17, the apparatus of claim 15 is as described. Ellis further teaches wherein the processor is configured to correct the body temperature, set the reference temperature, or increase or decrease the comparison result in a manner that offsets a difference between a first body temperature increase actually measured and a second body temperature increase estimated based on the pulse (Ellis: para. 88; Modify core body temperature depending on other metrics. Performing temperature correction based on reference profiles, which are generated on individual basis.).
Claim 19 recite substantially similar limitations as those already addressed in claim 1, and, as such, are rejected for similar reasons as given above.
Response to Arguments
Applicant's arguments filed for claims 1-17 and 19 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant argues that a thermometer has been recited to obtain temperature continuously, which is not a mental process. Examiner states that the thermometer has been analyzed as an additional element but operates in a generic manner and does not place the claim into a practical application.
The use of the term “continuously” does not disqualify the limitation from being categorized as an abstract idea. Language such as continuously, concurrently, automatically, instantly, or simultaneously to describe the automation of a manual process is not enough to overcome a subject matter eligibility rejection (MPEP § 2106.05(a)(I) Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality no. (iii) mere automation of manual processes. Examiner also notes that language such as this is not restricted to computer processes, humans can automatically/instantly/simultaneously complete different tasks (see MPEP § 2106.04(a)(2)(III) stating that the mental processes may be completely by humans plural – not just a singular human mind).
Applicant argues that the claim provides a technical improvement in the functioning of patient monitoring an diagnosis. Examiner disagrees. Applicant provides subjective opinion regarding the accuracy of the system and not objective evidence. The alleged improvement that the Applicant touts does not concern an improvement to computer capabilities but instead relates to an alleged improvement in receiving and processing information for which a computer is used as a tool in its ordinary capacity. Here, the Applicant is not trying to cure a shortcoming in existing computer technology. The Applicant does not contend that it was necessary to develop innovative computer hardware/software in order to perform the steps recited in independent claims.
Applicant’s arguments with respect to claims 1-17 and 19 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
De Pelsemaeker – WO 2022/096309 – Teaches a system for acquiring physiological measurements and generating a corrected value.
THIS ACTION IS MADE FINAL. 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 SHEETAL R. PAULSON whose telephone number is (571)270-1368. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marc Jimenez can be reached at (571) 272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3681