DETAILED ACTION
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 .
Status of Claims
In the response filed August 29, 2025, Applicant amended claims 10 and 12. Claims 1-20 are pending in the current application.
Response to Arguments
Applicant's arguments with respect to the rejection under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant asserts that claim 1 amounts to significantly more under step 2B because the claims is an unconventional combination of disparate data inputs, which is a technical solution to a technical problem that improves the functioning of patient monitoring technology. For an example, Applicant asserts that the prior art reference Soykan does not teach the combination of data, which underscores the unconventional nature of the claims. Examiner respectfully disagrees. As a whole, the devices and computer program (interpreted as computer environment) in the steps are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, the claims do not exhibit an improvement over conventional patient monitoring technology. The question of whether a particular claimed invention is novel or obvious is "fully apart" from the question of whether it is eligible. Diamond v. Diehr, 450 U.S. 175, 190, 209 USPQ 1, 9 (1981). For example, claims may exhibit an improvement over conventional computer functionality even if the improvement lacks novelty over the prior art (see MPEP 2106.05(d)). In this case, whether Soykan teaches the combination of data is separate from the analysis of whether the claims are directed to a technological improvement. This argument applies to dependent claims 8-12 and 16. The rejection is maintained.
Applicant's arguments with respect to the rejection under 35 U.S.C. 102 have been fully considered but they are not persuasive. Applicant asserts that Soykan does not teach or suggest “determining at least one quantifiable score based on the therapy data and at least one of sound, image, and video data of the patient or his environment.” Examiner respectfully disagrees. Paragraph [0144] of Soykan is being cited to show that the physiological data (therapy/treatment and sound data) is converted into disease scores (quantifiable score). The rejection is maintained.
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 claims are not directed to patent eligible subject matter.
Claims 1-20 do fall within at least one of the four categories of patent eligible subject matter because the claims recite a machine (i.e., system) and process (i.e., a method).
Although claims 1-20 fall under at least one of the four statutory categories, it should be determined whether the claim wholly embraces a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception (See MPEP 2106 I and II).
Claims 1-20 are directed to a judicial exception (i.e., a law of nature, natural phenomenon, or abstract idea) without significantly more.
Part I: Step 2A, Prong One: Identify the Abstract Idea
Under step 2A, Prong One of the Alice framework, the claims are analyzed to determine if the claims are directed to a judicial exception. MPEP §2106.04(a). The determination consists of a) identifying the specific limitations in the claim that recite an abstract idea; and b) determining whether the identified limitations fall within at least one of the three subject matter groupings of abstract ideas (i.e., mathematical concepts, mental processes, and certain methods of organizing human activity).
The identified limitations of independent claim 1 recite:
a) acquiring therapy data concerning a medical therapy, namely a dialysis treatment or a kidney replacement therapy, that is performed by a medical device on a patient,
b) acquiring sound, image and/or video data of the patient or his environment, and
c) determining at least one quantifiable score based on the therapy data and at least one of the sound, image and video data of the patient or his environment
The identified limitations of independent claim 16 recite:
at least one medical device having at least one data communication unit and configured to perform a medical therapy, namely a dialysis treatment or a kidney replacement therapy, on a patient,
at least one further device having at least one data communication unit, and
at least one computer program, wherein
the at least one medical device and the at least one further device are configured to exchange data directly or indirectly with each other by means of the respective data communication unit,
the at least one medical device and/or the at least one further device are configured to acquire therapy data concerning the medical therapy that is performed by the at least one medical device on the patient, and to acquire sound, image and/or video data of the patient or his environment, and
the at least one computer program comprises instructions which, when the program is executed by a computer, causes the computer to determine at least one quantifiable score based on the therapy data and at least one of the sound, image and video data of the patient or his environment.
The identified limitations, under their broadest reasonable interpretation, cover performance of the limitations in the mind (including observation, evaluation, judgment or opinion) but for the recitation of generic computer components. That is, other than reciting devices and computer program (interpreted as computer environment), nothing in the claim elements precludes the steps form practically being performed in the mind. For example, the identified limitations encompass a medical professional performing therapy and obtaining sound, image or video data of patient in therapeutic environment. The claim limitations fall within the Mental Processes groupings of abstract ideas. Thus, the claimed invention recites a judicial exception.
Part I: Step 2A, prong two: additional elements that integrate the judicial exception into a practical application
Under step 2A, Prong Two of the Alice framework, the claims are analyzed to determine whether the claims recite additional elements that integrate the judicial exception into a practical application. In particular, the claims are evaluated to determine if there are additional elements or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claims are more than a drafting effort designed to monopolize the judicial exception.
This judicial exception is not integrated into a practical application. As a whole, the devices and computer program (interpreted as computer environment) in the steps are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Dependent claims 2-15 and 17-20, when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed to an abstract idea.
Since these claims are directed to an abstract idea, the Office must determine whether the remaining limitations “do significantly more” than describe the abstract idea.
Part II. Determine whether any Element, or Combination, Amounts to“Significantly More” than the Abstract Idea itself
Under Part II, the steps of claims, when considered individually and as an ordered combination, do not improve another technology or technical field, do not improve the functioning of the computer itself, and are not enough to qualify as "significantly more". For example, the steps require no more than a conventional computer to perform generic computer functions. As stated above in Prong Two, the devices and computer program (interpreted as computer environment) in the steps are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Therefore, based on the two-part Mayo analysis, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself. Claims 1-20, when considered individually and as an ordered combination, are rejected as ineligible subject matter under 35 U.S.C. 101.
Dependent claims 2-15 and 17-20 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional claims do no recite significantly more than an abstract idea.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soykan et al. (US 2012/0277546 A1).
Regarding claim 1, Soykan discloses a computer-implemented method for automatically determining at least one quantifiable score, comprising the steps of:
a) acquiring therapy data concerning a medical therapy, namely a dialysis treatment or a kidney replacement therapy, that is performed by a medical device on a patient (Paragraph [0186]: many other patient parameters can be observed with sensors or inputted to evaluate the dialytic status of the patient, which can include both the effectiveness of dialysis treatment in replacing natural kidney function or complications due to dialysis treatment ),
b) acquiring sound, image and/or video data of the patient or his environment (Paragraphs [0140]: the accelerometer can have a 3-axis accelerometer capable of separately detecting heart and lung sounds or movement and respiration rate), and
c) determining at least one quantifiable score based on the therapy data and at least one of the sound, image and video data of the patient or his environment (Paragraph [0144]: A computational procedure, which can be referred to as the forward computational procedure, is used to convert the physiological signals into disease scores).
Regarding claim 2, Soykan discloses the method according to claim 1, wherein step a) comprises acquiring therapy data concerning the dialysis treatment, and the dialysis treatment comprises a peritoneal dialysis, a hemofiltration, a hemodialysis, a hemodiafiltration, and/or an apheresis (Paragraph [0129]).
Regarding claim 3, Soykan discloses the method according to claim 1,wherein step a) comprises acquiring data concerning a duration and a kind of the medical therapy, a number and a kind of occurred alarms during the medical therapy, indications due to technical malfunctions and/or medical complications output by the medical device, and/or therapy-specific indices (Paragraph [0182]).
Regarding claim 4, Soykan discloses the method according to claim 3, wherein step a) comprises acquiring therapy data concerning the kidney replacement therapy that is performed by the medical device on the patient, and the therapy-specific indices include a clearance, a Kt/V, an ultrafiltration volume, and/or a proportion of the urea level before, during and/or after the medical therapy (Paragraph [0186]).
Regarding claim 5, Soykan discloses the method according to claim 1, further comprising acquiring physiological data of the patient, and/or of other people and/or of other species in the environment of the patient, wherein step c) comprises determining the at least one quantifiable score based on the therapy data and the physiological data and at least one of the sound, image and video data of the patient or his environment (Paragraph [0140]).
Regarding claim 6, Soykan discloses the method according to claim 5, wherein acquiring physiological data of the patient comprises acquiring a weight, an oxygen saturation, a heart rate, a blood pressure, a body temperature, a breathing rate, an eye or eyelid movements, a conductivity of the skin and/or a liquid state of the patient, and acquiring physiological data of the patient and/or of other people and/or of other species in the environment of the patient comprises acquiring a size, shape and/or movement of the pupils, blinking, fixations and/or saccades, facial expression, skin pallor, speech, speech volume, speech speed, prosody, tones and/or sounds of the patient and/or of other people and/or of other species in the environment of the patient (Paragraph [0051]).
Regarding claim 7, Soykan discloses the method according to claim 1,wherein determining the at least one quantifiable score comprises processing the sound and/or image data and/or video data of the patient or his environment using Natural Language Processing, Sound Processing, Eye Tracking and Processing, Sentiment Analysis using any combination of Convolutional Neural Networks, Transfer Learning, Recurrent Neural Networks, Long-Short-Term Memory Networks, Reinforcement Learning, Auto Encoder and/or Generative Adversarial Networks (Paragraph [0184]).
Regarding claim 8, Soykan discloses the method according to claim 1, further comprising transmitting the determined at least one quantifiable score to a device accessible by an authorized person and outputting a notification about the determined at least one quantifiable score using the device and/or processing the determined at least one quantifiable score by a computer program (Paragraph [0184]).
Regarding claim 9, Soykan discloses the method according to claim 8, further comprising determining whether one or more of the determined at least one quantifiable score exceeds an upper threshold value and/or is lower than a lower threshold value, and transmitting the one or more of the determined at least one quantifiable score to the device accessible by the authorized person and outputting the notification about the one or more of the determined at least one quantifiable score using the device, and/or processing the one or more of the determined at least one quantifiable score by the computer program, if it is determined that the one or more of the determined at least one quantifiable score exceeds the upper threshold value and/or is lower than the lower threshold value (Paragraph [0200]).
Regarding claim 10, Soykan discloses the method according to claim 9, further comprising outputting, using the device, a recommendation of subjecting the patient to at least one medical intervention including a medical treatment, a medication administration or a surgical intervention including a transplantation and a vascular surgery, and/or outputting, using the device, a recommendation of subjecting the patient to at least one medical examination, if it is determined that the one or more of the determined at least one quantifiable score exceeds the upper threshold value and/or is lower than the lower threshold value (Paragraph [0133]).
Regarding claim 11, Soykan discloses the method according to claim 9, further comprising determining, based on the acquired physiological data and/or the determination whether one or more of the determined at least one quantifiable score exceeds the upper threshold value and/or is lower than the lower threshold value, whether the patient is in a critical condition, wherein the determined at least one quantifiable score and the one or more of the determined at least one quantifiable score which exceeds the upper threshold value and/or is lower than the lower threshold value, respectively, is transmitted to the device accessible by the authorized person and the notification about the determined at least one quantifiable score and the one or more of the determined at least one quantifiable score which exceeds the upper threshold value and/or is lower than the lower threshold value, respectively, is output using the device and/or the determined at least one quantifiable score and the one or more of the determined at least one quantifiable score which exceeds the upper threshold value and/or is lower than the lower threshold value, respectively, is processed by the computer program, if it is determined that the patient is in the critical condition (Paragraph [0184]).
Regarding claim 12, Soykan discloses the method according to claim 8, wherein the determined at least one quantifiable score and the one or more of the determined at least one quantifiable score which exceeds the upper threshold value and/or is lower than the lower threshold value, respectively, is transmitted to the device accessible by the authorized person and the notification about the determined at least one quantifiable score and the determined one or more of the determined at least one quantifiable score, respectively, is output using the device and/or the determined at least one quantifiable score and the one or more of the determined at least one quantifiable score which exceeds the upper threshold value and/or is lower than the lower threshold value, respectively, is processed by the computer program only if a corresponding consent given by the patient is received (Paragraph [0184]).
Regarding claim 13, Soykan discloses the method according to claim 1,wherein determining the at least one quantifiable score is performed using mathematical rules and/or mathematical functions (Paragraph [0148]).
Regarding claim 14, Soykan discloses the method according to claim 1,wherein determining the at least one quantifiable score is performed using machine learning and/or deep learning and/or classical data processing algorithms of statistics (Paragraph [0207]).
Regarding claim 15, Soykan discloses the method according to claim 1,wherein determining the at least one quantifiable score comprises determining at least one probability value for at least one patient event, wherein the at least one patient event includes a hospitalization of the patient, a development of a mental illness of the patient, a deterioration of at least one health value of the patient, or a death of the patient (Paragraph [0181]).
Regarding claim 16, Soykan discloses a medical system for automatically determining a quantifiable score, the medical system comprising:
at least one medical device having at least one data communication unit and configured to perform a medical therapy, namely a dialysis treatment or a kidney replacement therapy, on a patient (Paragraph [0186]: many other patient parameters can be observed with sensors or inputted to evaluate the dialytic status of the patient, which can include both the effectiveness of dialysis treatment in replacing natural kidney function or complications due to dialysis treatment ),
at least one further device having at least one data communication unit (Paragraph [0234]), and
at least one computer program (Paragraph [0030]), wherein
the at least one medical device and the at least one further device are configured to exchange data directly or indirectly with each other by means of the respective data communication unit (Paragraph [0008]),
the at least one medical device and/or the at least one further device are configured to acquire therapy data concerning the medical therapy that is performed by the at least one medical device on the patient, and to acquire sound, image and/or video data of the patient or his environment(Paragraphs [0140] and [0186]: the accelerometer can have a 3-axis accelerometer capable of separately detecting heart and lung sounds or movement and respiration rate), and
the at least one computer program comprises instructions which, when the program is executed by a computer, causes the computer to determine at least one quantifiable score based on the therapy data and at least one of the sound, image and video data of the patient or his environment (Paragraph [0186]: kidney disease score).
Regarding claim 17, Soykan discloses a system for adapting a therapy plan for a patient, comprising the medical system according to claim 16, wherein the at least one computer program comprises instructions which, when the program is executed by the computer, causes the computer to change or optimize a therapy plan of the medical therapy including shortening therapy sessions of the medical therapy and/or changing a kind of the medical therapy depending on the determined at least one quantifiable score and optionally depending on other patient-related data (Paragraph [0226]).
Regarding claim 18, Soykan discloses a system for automatically determining at least one quantifiable score, the system comprising: the medical system according to claim 16,
at least one computer accessible by authorized personal of a clinic and having a data processing unit and a communication unit (Paragraph [0190]),
at least one computer accessible by an established physician and having a data processing unit and a communication unit (Paragraph [0190]),
at least one computer accessible by a medical device manufacturer and having a data processing unit and a communication unit (Paragraph [0190]), and
a central data processing unit having a data processing unit and a communication unit (Paragraph [0190]), wherein
the at least one medical device and/or the at least one further device are configured to transmit the acquired therapy data, acquired psychological data, and the acquired sound, image and/or video data of the patient or his environment to the central data processing unit(Paragraph [0190]),
the at least one computer accessible by an established physician is configured to transmit anamnesis data, current test data and/or patient history data of the patient to the central data processing, (Paragraph [0190])
the at least one computer accessible by authorized personal of a clinic is configured to transmit clinic data regarding the patient to the central processing unit (Paragraph [0190]),
the at least one computer accessible by a medical device manufacturer is configured to transmit data concerning the at least one medical device to the central data processing unit (Paragraph [0190]),
the central data processing unit is configured to determine the at least one quantifiable score based on the therapy data and at least one of the sound, image and/or video data of the patient or his environment, and optionally based on the acquired psychological data transmitted from the at least one medical device and/or the at least one further device and optionally based on the clinic data regarding the patient transmitted from the at least one computer accessible by authorized personal of a clinic and/or the anamnesis data, current test data and/or patient history of the patient transmitted from the at least one computer accessible by an established physician and/or the data concerning the at least one medical device transmitted from the at least one computer accessible by a medical device manufacturer (Paragraph [0186]).
Regarding claim 19, Soykan discloses the a system for automatically determining at least one quantifiable score, the system comprising: the system according to claim 17,
at least one computer accessible by authorized personal of a clinic and having a data processing unit and a communication unit (Paragraph [0190]),
at least one computer accessible by an established physician and having a data processing unit and a communication unit (Paragraph [0190]),
at least one computer accessible by a medical device manufacturer and having a data processing unit and a communication unit (Paragraph [0190]), and
a central data processing unit having a data processing unit and a communication unit (Paragraph [0190]),
wherein the at least one medical device and/or the at least one further device are configured to transmit the acquired therapy data, acquired psychological data, and the acquired sound, image and/or video data of the patient or his environment to the central data processing unit (Paragraph [0190]),
the at least one computer accessible by an established physician is configured to transmit anamnesis data, current test data and/or patient history data of the patient to the central data processing(Paragraph [0190]),
the at least one computer accessible by authorized personal of a clinic is configured to transmit clinic data regarding the patient to the central processing unit (Paragraph [0190]),
the at least one computer accessible by a medical device manufacturer is configured to transmit data concerning the at least one medical device to the central data processing unit, the central data processing unit is configured to determine the at least one quantifiable score based on the therapy data and at least one of the sound, image and/or video data of the patient or his environment, and optionally based on the acquired psychological data transmitted from the at least one medical device and/or the at least one further device and optionally based on the clinic data regarding the patient transmitted from the at least one computer accessible by authorized personal of a clinic and/or the anamnesis data, current test data and/or patient history of the patient transmitted from the at least one computer accessible by an established physician and/or the data concerning the at least one medical device transmitted from the at least one computer accessible by a medical device manufacturer (Paragraph [0186]).
Regarding claim 20, Soykan discloses the method according to claim 9, further comprising outputting, using the device, a recommendation of subjecting the patient to at least one medical intervention including a medical treatment that is a dialysis treatment, and/or outputting, using the device, a recommendation of subjecting the patient to at least one medical examination that is a sonography, a magnetic resonance tomography or a computed tomography, if it is determined that the one or more of the determined at least one quantifiable score exceeds the upper threshold value and/or is lower than the lower threshold value (Paragraph [0133]).
Conclusion
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.
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/CHINYERE MPAMUGO/Primary Examiner, Art Unit 3685