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 .
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
This action is a final rejection
Claims 1, 3-8, 10, 12-18 are pending
Claims 2, 9, 11 were cancelled
Claims 17, 18 were added
Claims 1, 14, 15 were amended
Claims 1, 3-8, 10, 12-18 are rejected under 35 USC § 101
Claims 1, 3-8, 10, 12-18 are rejected under 35 USC § 103
Priority
Acknowledgement is made of Applicant’s claim for a foreign priority date of 11-15-2019
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4-26-2022, 12-6-2022, 5-9, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1, limitation 4 is objected to because of the following informalities: The claim recites: “outputting, to an information terminal via the communication controller, information indicating that the dosage can be increased on the condition that the determining determines that there is not the possibility”. At the end of the claim after the word “possibility” the following missing words similar to those recited in claims 14 and 15 should be added: “of occurrence of the waveform abnormality in the patient“. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 14, 15, 16 meet the three-prong test and therefore invokes § 112(f). The words of the claim do not rebut the presumption that the claim limitation is to be interpreted under § 112(f).
Regarding claim 14
The Examiner interprets “an acquisition part that acquires electrocardiogram data indicating an electrocardiogram of a patient who is given the drug with the administration method and the dosage” as invoking 35 U.S.C. §112(f). Consistent with “The control part 11 is a processor such as a central processing unit (CPU), and functions as the acquisition part 111 “of Applicant’s specification [0016], the Examiner is interpreting “an acquisition part” as a processor that functions as an acquisition part.
The Examiner interprets “an output part that outputs information about advisability of modifying at least one of the administration method or the dosage on the basis of a result of determining, on the basis of the electrocardiogram data, whether a waveform abnormality that can be evaluated with an electrocardiogram may have occurred in the patient” as invoking 35 U.S.C. §112(f). Consistent with “The control part 11 is a processor such as a central processing unit (CPU), and functions as … the output part 113 “ of Applicant’s specification [0016], the Examiner is interpreting “an output part” as a processor that functions as an output part.
Regarding claim 15
The Examiner interprets “Measurement part” as invoking 35 U.S.C. §112(f). Consistent with “the electrocardiograph includes: a measurement part that measures an electrocardiogram “ of Applicant’s specification [0006], the Examiner is interpreting “Measurement part” as one that is part of an electrocardiograph used to measure an electrocardiogram.
The Examiner interprets “Transmitting part” as invoking 35 U.S.C. §112(f). Consistent with “the electrocardiograph includes: a transmitting part that transmits electrocardiogram data indicating the electrocardiogram“ of Applicant’s specification [0006], the Examiner is interpreting “Transmitting part” as one that is part of an electrocardiograph used to transmit an electrocardiogram
The Examiner interprets “an acquisition part that acquires the electrocardiogram data transmitted by the electrocardiograph” as invoking 35 U.S.C. §112(f). Consistent with “The control part 11 is a processor such as a central processing unit (CPU), and functions as the acquisition part 111 “of Applicant’s specification [0016], the Examiner is interpreting “an acquisition part” as a processor that functions as an acquisition part.
The Examiner interprets “an output part that outputs information about advisability of modifying at least one of the administration method or the dosage on the basis of a result of determining, on the basis of the electrocardiogram data, whether a waveform abnormality that can be evaluated with the electrocardiogram may have occurred in the patient” as invoking 35 U.S.C. §112(f). Consistent with “The control part 11 is a processor such as a central processing unit (CPU), and functions as … the output part 113 “ of Applicant’s specification [0016], the Examiner is interpreting “an output part” as a processor that functions as an output part.
Regarding claim 16
The Examiner interprets “table indicating increase candidate values stored in advance in a storage part” as invoking 35 U.S.C. §112(f). Consistent with “The information output apparatus 1 includes …. a storage part 13. The storage part 13 is a storage medium including a read only memory (ROM), a random access memory (RAM), a hard disk, and the like. The storage part 13 stores in advance a program executed by the control part 11“ of Applicant’s specification [0014, 0015], the Examiner interprets “ storage part” as part of the information output apparatus that stores a program executed by the control part 11.
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, 3-8, 10, 12-18 are not patent eligible because the claimed invention is directed to an abstract idea without significantly more.
Analysis
First, claims are directed to one or more of the following statutory categories: a process, a machine, a manufacture, and a composition of matter. Regarding claims 1, 3-8, 10, 12-18 the claims recite an abstract idea of determining a dosage of a drug administrable to a patient.
Independent Claims 1, 14 and 15 are rejected under 35 U.S.C 101 based on the following analysis.
-Step 1 (Does the claim fall within a statutory category? YES): claim 1 recites a method used for determining a dosage of a drug administrable to a patient.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
acquiring, normal electrocardiogram data indicating an electrocardiogram of a patient who is not given the drug where there is no possibility of occurrence of a waveform abnormality able to be evaluated with an electrocardiogram in the patient
acquiring, electrocardiogram data indicating an electrocardiogram of the patient who is given the drug with the dosage;
determining, by comparing the normal electrocardiogram data and the electrocardiogram data, which are acquired, whether there is a possibility of occurrence of the waveform abnormality in the patient; and
outputting, , information indicating that the dosage can be increased on the condition that the determining determines that there is not the possibility.
re-acquiring, after the dosage has been increased, electrocardiogram data of the patient who is given the drug with the modified dosage;
re-determining whether there is the possibility on the basis of the re-acquired electrocardiogram data which is acquired; and
re-outputting, information indicating that the dosage can be increased on the condition that the re-determining determines that there is not the possibility;
specifying a degree of risk of increasing the dosage corresponding to a difference between (i) the electrocardiogram data of the patient who is given the drug at the dosage and (ii) the electrocardiogram data of the patient who is given the drug at the modified dosage, wherein the greater the difference, the greater the degree of risk, and the smaller the difference, the smaller the degree of risk; and
outputting, information indicating the degree of risk, wherein the determining and re-determining steps include ... determine the possibility of waveform abnormality.
belong to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “determining a dosage of a drug administrable to a patient”. Alternatively, it belongs to certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “determining a dosage of a drug administrable to a patient”. (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). Claim 1 recites:
executed by a processor;
wearable electrocardiograph via a communication controller;
an information terminal via the communication controller;
inputting the electrocardiogram data into a machine learning model trained on electrocardiograms of normal and abnormal states.
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs (0010-0017). (refer to MPEP 2106.05(f)). Accordingly, these additional elements, when considered separately and as an ordered combination do not integrate the judicial exception/abstract idea into a “practical application” of the judicial exception because they do not impose any meaningful limit on practicing the judicial exception.
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two, claim 1 recites:
executed by a processor;
wearable electrocardiograph via a communication controller;
an information terminal via the communication controller
inputting the electrocardiogram data into a machine learning model trained on electrocardiograms of normal and abnormal states;
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)) Accordingly, even when viewed as a whole the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
-Step 1 (Does the claim fall within a statutory category? YES): claim 14 recites an apparatus used for determining a dosage of a drug that can be administered to a patient.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
Acquires normal electrocardiogram data indicating an electrocardiogram of the patient who is not given the drug where there is no possibility of occurrence of a waveform abnormality able to be evaluated with an electrocardiogram in the patient, and
acquires electrocardiogram data indicating an electrocardiogram of the patient who is given the drug with the dosage; and
an output part that outputs information indicating that the dosage is able to be increased on the condition of determining, by comparing the normal electrocardiogram data and the electrocardiogram data which are acquired, that there is not a possibility of occurrence of the waveform abnormality in the patient.
wherein re-acquires, after the dosage has been increased, electrocardiogram data of the patient who is given the drug with the modified dosage;
the output part re-determines whether there is the possibility on the basis of the re-acquired electrocardiogram data which is acquired; and
re-outputs, information indicating that the dosage can be increased on the condition that the output part re- determines that there is not the possibility;
specifies a degree of risk of increasing the dosage corresponding to a difference between (i) the electrocardiogram data of the patient who is given the drug at the dosage and (ii) the electrocardiogram data of the patient who is given the drug at the modified dosage, wherein the greater the difference, the greater the degree of risk, and the smaller the difference, the smaller the degree of risk; and
outputs, information indicating the degree of risk wherein the determining and re-determining steps include .. determine the possibility of waveform abnormality.
belong to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “determining a dosage of a drug administrable to a patient”. Alternatively, it belongs to certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “determining a dosage of a drug administrable to a patient”. (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). Claim 14 recites:
a communication controller
an acquisition part;
a wearable electrocardiograph via the communication controller;
an information terminal via the communication controller,
the output part;
inputting the electrocardiogram data into a machine learning model trained on electrocardiograms of normal and abnormal states.
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs (0010-0017). (refer to MPEP 2106.05(f)). Accordingly, these additional elements, when considered separately and as an ordered combination do not integrate the judicial exception/abstract idea into a “practical application” of the judicial exception because they do not impose any meaningful limit on practicing the judicial exception.
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two, claim 14 recites:
a communication controller
an acquisition part;
a wearable electrocardiograph via the communication controller;
an information terminal via the communication controller,
the output part;
inputting the electrocardiogram data into a machine learning model trained on electrocardiograms of normal and abnormal states.
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)) Accordingly, even when viewed as a whole the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
-Step 1 (Does the claim fall within a statutory category? YES): claim 15 recites a system used for determining a dosage of a drug that can be administered to a patient.
-Step 2A Prong One (Does the claim fall within at least one of the groupings of abstract ideas?: YES): The claimed invention:
measures a normal electrocardiogram of the patient who is not given the drug where there is no possibility of occurrence of a waveform abnormality able to be evaluated with an electrocardiogram in the patient, and measures an electrocardiogram of the patient who is given the drug with the dosage;
transmits normal electrocardiogram data indicating the normal electrocardiogram, and transmits electrocardiogram data indicating the electrocardiogram; and
acquires, the normal electrocardiogram data and the electrocardiogram data; and
outputs information indicating that the dosage is able to be increased on the condition of determining, by comparing the normal electrocardiogram data and the electrocardiogram data which are acquired, that there is not a possibility of occurrence of the waveform abnormality in the patient,
wherein re-acquires, after the dosage has been increased, electrocardiogram data of the patient who is given the drug with the modified dosage;
the output part re-determines whether there is the possibility on the basis of the re-acquired electrocardiogram data which is acquired from the wearable electrocardiograph via the communication controller; and
re-outputs, information indicating that the dosage can be increased on the condition that re- determines that there is not the possibility;
specifies a degree of risk of increasing the dosage corresponding to a difference between (i) the electrocardiogram data of the patient who is given the drug at the dosage and (ii) the electrocardiogram data of the patient who is given the drug at the modified dosage wherein the greater the difference, the greater the degree of risk, and the smaller the difference, the smaller the degree of risk; and
outputs, information indicating the degree of risk, wherein the determining and re-determining steps include determine the possibility of waveform abnormality.
belong to the grouping of mental processes under concepts performed in the human mind (including an observation, evaluation, judgement, opinion) as it recites “determining a dosage of a drug administrable to a patient”. Alternatively, it belongs to certain methods of organizing human activity under managing personal behavior or relationships or interactions between people as it recites “determining a dosage of a drug administrable to a patient”. (refer to MPP 2106.04(a)(2)). Accordingly this claim recites an abstract idea.
-Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). Claim 15 recites:
an information output apparatus;
a wearable electrocardiograph;
a measurement part;
a transmitting part;
a communication controller
an acquisition part;
wearable electrocardiograph via the communication controller;
an output part;
an information terminal via the communication controller;
inputting the electrocardiogram data into a machine learning model trained on electrocardiograms of normal and abnormal states .
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. Support for this can be found in the specification, paragraphs (0010-0017). (refer to MPEP 2106.05(f)). Accordingly, these additional elements, when considered separately and as an ordered combination do not integrate the judicial exception/abstract idea into a “practical application” of the judicial exception because they do not impose any meaningful limit on practicing the judicial exception.
-Step 2B (Does the additional elements of the claim provide an inventive concept?: NO. As discussed previously with respect to Step 2A Prong Two, claim 15 recites:
an information output apparatus;
a wearable electrocardiograph;
a measurement part;
a transmitting part;
a communication controller
an acquisition part;
wearable electrocardiograph via the communication controller;
an output part;
an information terminal via the communication controller;
inputting the electrocardiogram data into a machine learning model trained on electrocardiograms of normal and abnormal states.
Amounting to mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)) Accordingly, even when viewed as a whole the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible.
Dependent Claims:
Step 2A Prong One: The following dependent claims recites additional limitations that further define the abstract idea of determining a dosage of a drug administrable to a patient. The claim limitations include:
Claim 3: wherein, for every modification of the dosage, the re-acquiring includes repeating re-acquiring of the electrocardiogram data of the patient who is given the drug at the modified dosage, and ending the re-acquiring of the electrocardiogram data when the modified dosage reaches a predetermined upper limit value or when the modification of the dosage reaches a predetermined number of times.
Claim 4: wherein the acquiring includes acquiring the electrocardiogram data indicating an electrocardiogram occurring in everyday life of the patient.
Claim 5: wherein the acquiring includes sequentially acquiring the electrocardiogram data from an electrocardiograph worn by the patient in his/her daily life.
Claim 6: wherein the determining includes determining, as the waveform abnormality, whether there is a possibility of occurrence of a waveform indicating that arrhythmia is present or may occur.
Claim 7: wherein the determining includes determining, as the waveform abnormality, whether there is a possibility of occurrence of a waveform indicating that an adverse event that can be evaluated with an electrocardiogram is present.
Claim 8: wherein the determining includes determining whether there is a possibility of occurrence of the waveform abnormality by detecting at least one of QT prolongation, atrial fibrillation, ventricular tachycardia, supraventricular extrasystole, premature ventricular contraction, atrial flutter, or atrial tachycardia in the electrocardiogram data.
Claim 10: wherein the outputting indicating that the dosage is able to be increased includes transmitting information indicating that the dosage is able to be increased
Claim 12: wherein the obtaining includes obtaining the electrocardiogram data of the patient who is given the drug for therapeutic purposes or for purposes of clinical trials.
Claim 13: wherein the outputting includes outputting a value to be added to or multiplied by the initial dosage in order to increase the initial dosage when it is determined that there is no possibility of occurrence of the waveform abnormality.
Claim 16: specifying the value to be added to or multiplied by the initial dosage in accordance with an increase table indicating increase candidate values stored in advance
Claim 17: wherein the determining the possibility of occurrence of the waveform abnormality by detecting the QT prolongation in the electrocardiogram data comprises analyzing a change in the QT interval relative to a predetermined threshold derived from the normal electrocardiogram data;
Claim 18: wherein the increase candidate value is added to or multiplied by the current dosage when no waveform abnormality is detected.
Step 2A Prong Two (Are there additional elements in the claim that imposes a meaningful limit on the abstract idea? NO). The following dependent claims recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claims as a whole do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims include:
Claim 5: an electrocardiograph;
Claim 10: information terminal;
Claim 16: storage part.
Step 2B (Does the additional elements of the claim provide an inventive concept?: NO). As discussed previously with respect to Step 2A Prong Two, the following dependent claims recite mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to implement the abstract idea. (refer to MPEP 2106.05(f)). Accordingly, the claim does not provide an inventive concept (significantly more than the abstract idea) and hence the claim is ineligible. The claims include:
Claim 5: an electrocardiograph;
Claim 10: information terminal;
Claim 16: storage part.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or
non-obviousness.
Claims 1, 3-8, 10, 12-15 are rejected under 35 U.S.C. 103 as being un-patentable by Hunt et.al (WO 2008149159 A2) hereinafter “Hunt”, in view of Park et.al. (WO 2016070128 A1) hereinafter “Park”, in view of Srinivasan et.al. (US 20180333411 A1) hereinafter “Srinivasan”, in further view of Charles et.al. (US 20190374166 A1) hereinafter “Charles”
Regarding claims 1, 14 and 15 Hunt teaches:
acquiring [from a wearable electrocardiograph via a communication controller] normal electrocardiogram (baseline electrocardiogram) data indicating an electrocardiogram of a patient who is not given the drug (drug .. has not been administered) where there is no possibility of occurrence of a waveform abnormality able to be evaluated with an electrocardiogram (a typical epicardial electrocardiogram) in the patient (See at least [page 4, lines 9-10] via: “…obtaining a baseline electrocardiogram recorded on the body surface of a person to whom the drug under test has not been administered…”; in addition see at least [page 9, lines 28-30] via: “… Input means for the input of a baseline electrocardiogram recorded on the body surface of a person to whom the drug under test has not been administered, a typical epicardial electrocardiogram..”) The Examiner interprets typical epicardial electrocardiogram as recited by Hunt equivalent to the normal electrocardiogram of the claim that has no waveform abnormalities.
acquiring [from the wearable electrocardiograph via the communication controller], electrocardiogram data indicating an electrocardiogram of the patient (second electrocardiogram ) who is given the drug (to whom the drug .. has been administered) with the dosage; (See at least [page 9, lines 30-32] via: “… a typical epicardial electrocardiogram and a second electrocardiogram recorded on the body surface of an individual to whom the drug under test has been administered..)
determining, by comparing the normal electrocardiogram (baseline electrocardiogram) data andthe electrocardiogram data (second electrocardiogram), [which are acquired from the wearable electrocardiograph via the communication controller], whether there is a possibility of occurrence of the waveform abnormality in the patient (The greater magnitude of effect in the T-T interval variability may make this a potent clinical biomarker of drug induced arrhythmia); (See at least [page 4, lines 5-30] via: “…In a first aspect of the invention there is provided a non-invasive method of measurement of drug induced changes in cardiac ion channel and electrical function said method comprising: Obtaining a baseline electrocardiogram recorded on the body surface of a person to whom the drug under test has not been administered. Obtaining a second electrocardiogram recorded on the body surface of an individual to whom the drug under test has been administered. Using said representative epicardial electrocardiogram to measure any drug induced changes in cardiac ionic channel and electrical function as a result of said drug under test. ..”; in addition see at least [page 9, lines 24-32 and page 10, lines 1-15] via: “…there is provided apparatus for the non-invasive measurement of drug induced changes in cardiac function, said apparatus comprising: Input means for the input of a baseline electrocardiogram recorded on the body surface of a person to whom the drug under test has not been administered, a typical epicardial electrocardiogram and a second electrocardiogram recorded on the body surface of an individual to whom the drug under test has been administered; Means for comparing said surface baseline electrocardiogram to a typical epicardial electrocardiogram. Means for using said representative epicardial electrocardiogram to measure any drug induced changes in cardiac ionic and electrical function as a result of said drug under test…”; in addition see at least [page 10, lines 1-2] via: “… comparing said surface baseline electrocardiogram to a typical epicardial electrocardiogram…”; in addition see at least [Page 19, lines 27-33 and Page 20, lines 1-5] via: “… instability of the AP duration, which is the beat to beat variation in AP duration, is a potent predictor of drug induced proarrhythmia. At any given cycle length a long AP duration manifesting on ECG as a long QT interval is followed is followed by a shorter time interval between the preceding peak T wave and the following Q wave (the T-Q) interval. This then results in a subsequent shorter AP duration ie a shorter ECG Q-T interval that is followed by a longer T-Q interval which is followed by a longer QT etc. The result of this is a beat to beat variation in the QT interval and also possibly more variation in the beat to beat T-T interval. The greater magnitude of effect in the T-T interval variability may make this a potent clinical biomarker of drug induced arrhythmia…”)
However Hunt is silent the following limitations that are taught by Park
from a wearable (may be worn .. by a human) electrocardiograph (physiological monitoring device) via a communication controller (transmitting devices 2004) includes a measurement part and a transmitting part (See at least [0005] via: “…a physiological monitoring device that may be worn continuously and comfortably by a human or animal subject for at least one week or more and more typically two to three weeks or more. In one embodiment, the device is specifically designed to sense and record cardiac rhythm (for example, electrocardiogram, ECG) data..”; in addition see at least [0151] via: “… Figure 11 is a schematic illustration of an embodiment of a system and method 1000 for a wearable medical sensor 1002 with transmission capabilities, similar to the system and/or method described above in relation to Figure 10…”; in addition see at least [0160] via: “… Figure 12 is a schematic illustration of an embodiment of a system and method 2000 for a wearable ECG and/or medical sensor 2002 with transmission capabilities very similar to the system and/or method 1000 described above in relation to Figure 11. The system of Figure 12 differs from the system of Figure 11 in that it includes secondary transmitting devices 2004. For example, possible secondary transmitting devices include: smartphones, tablets, personal computers, dedicated custom gateways, audio devices, wearable activity monitors, automobile consoles, other devices…”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Hunt to incorporate the teachings of Park. Those in the art would have recognized that Hunt’s teaching regarding comparing an electrocardiogram before a drug is applied to a patient to one taken after applying the drug and detecting any changes in the QT interval, commonly computed to determine if there is abnormal QT interval prolongation for a patient could be modified by Park’s teaching reciting a cardiac monitoring system, whereby the cardiac information is detected, recorded and transmitted continuously via a wearable device, and whereby the extracted data features may then be analyzed and used in clinical diagnosis related to the titrated dosage of therapeutic drugs administered to patients. This combination would be very beneficial in obtaining data related to the patient’s heart on a continuous basis in order to monitor any adverse changes related to varying amount of drug dosages applied to a patient.
Outputting to an information terminal (transmitted 1010 to a processing device/server 1012) via the communication controller (transmitting devices 2004), information indicating that the dosage can be increased (adjusting the dosage) on the condition that the determining determines that there is not the possibility (adjusting the dosage or frequency as a means to eliminate observed prolongation). (See at least [0050] via: “…receiving, by a server computer through a communication link, physiological sensor data generated by a patient monitoring device, the physiological sensor data associated with a first patient..”; in addition see at least [0141] via: “…a system for selective transmission of electrocardiographic signal data from a wearable medical sensor. … In many situations however, it is desirable for the sensor to be able to transmit, in real-time or near real-time, specific sections of the recorded ECG signal with clinical relevance to a computer device, such as either a smartphone 912 or an internet-connected gateway device 914 for subsequent processing and analysis. In this way, the patient or their physician can be provided with potentially valuable diagnostic ECG information during the period that the patient wears the sensor. ..”; in addition see at least [0151] via: “… Figure 11 is a schematic illustration of an embodiment of a system and method 1000 for a wearable medical sensor 1002 with transmission capabilities, similar to the system and/or method described above in relation to Figure 10…”; in addition see at least [0156] via: “…Once the feature extraction as described above is completed, various features 1008 may then be transmitted 1010 to a processing device/server 1012…”; in addition see at least [0160] via: “… Figure 12 is a schematic illustration of … a wearable ECG and/or medical sensor 2002 with transmission capabilities .. in that it includes secondary transmitting devices 2004…”; in addition see at least [0084] via: “…The theme can also extend to more subtle changes in morphology, for example, QT prolongation in response to medications, which has been shown to have significant cardiac safety implications. Timely awareness of such prolongation could lead, for example, to early termination of clinical studies evaluating drug safety and effectiveness or, alternatively, to adjusting the dosage or frequency as a means to eliminate observed prolongation..”; in addition see at least [0083] via: “…Making this information available in a timely manner during the monitoring period could allow the managing physician to iteratively titrate treatment, for example, by adjusting the dosage and frequency of a novel oral anticoagulant drug (NOAC) until management was optimized.…”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Hunt to incorporate the teachings of Park. Those in the art would have recognized that Hunt’s teaching regarding comparing an electrocardiogram before a drug is applied to a patient to one taken after applying the drug and detecting any changes in the QT interval, commonly computed to determine if there is abnormal QT interval prolongation for a patient could be modified by Park’s teaching reciting a cardiac monitoring system, whereby the cardiac information is detected, recorded and transmitted continuously via a wearable device, and whereby the extracted data features may then be analyzed and used in clinical diagnosis related to the titrated dosage of therapeutic drugs administered to patients. This combination would be very beneficial in obtaining data related to the patient’s heart on a continuous basis in order to monitor any adverse changes related to varying amount of drug dosages applied to a patient.
re-acquiring, from the wearable electrocardiograph via the communication controller, after the dosage has been increased, electrocardiogram data of the patient who is given the drug with the modified dosage; (See at least [0141] via: “…a system for selective transmission of electrocardiographic signal data from a wearable medical sensor…”; in addition see at least [0160] via: “… Figure 12 is a schematic illustration of … a wearable ECG and/or medical sensor 2002 with transmission capabilities .. in that it includes secondary transmitting devices 2004…”; in addition see at least [0083] via: “…during the monitoring period could allow the managing physician to iteratively titrate treatment, for example, by adjusting the dosage and frequency of a novel oral anticoagulant drug (NOAC) until management was optimized...”) The Examiner’s BRI interprets “re-acquiring.. after the dosage has been increased, electrocardiogram data of the patient who is given the drug with the modified dosage” as recited by the claim to be equivalent to Park’s teaching of iterative titration treatment by adjusting the dosage and frequency of a drug. In medicine the meaning of titrate is to continuously measure and adjust the balance of a physiological function or drug dosage and in this case re-acquiring at an increased dose is part of the action of titrating a dose.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Hunt to incorporate the teachings of Park. Those in the art would have recognized that Hunt’s teaching regarding comparing an electrocardiogram before a drug is applied to a patient to one taken after applying the drug and detecting any changes in the QT interval, commonly computed to determine if there is abnormal QT interval prolongation for a patient could be modified by Park’s teaching reciting a cardiac monitoring system, whereby the cardiac information is detected, recorded and transmitted continuously via a wearable device, and whereby the extracted data features may then be analyzed and used in clinical diagnosis related to the titrated dosage of therapeutic drugs administered to patients. This combination would be very beneficial in obtaining data related to the patient’s heart on a continuous basis in order to monitor any adverse changes related to varying amount of drug dosages applied to a patient.
re-determining whether there is the possibility on the basis of the re-acquired electrocardiogram data which is acquired from the wearable electrocardiograph via the communication controller; (See at least [0141] via: “…a system for selective transmission of electrocardiographic signal data from a wearable medical sensor…”; in addition see at least [0160] via: “… Figure 12 is a schematic illustration of … a wearable ECG and/or medical sensor 2002 with transmission capabilities .. in that it includes secondary transmitting devices 2004…”; in addition see at least [0083] via: “…during the monitoring period could allow the managing physician to iteratively titrate treatment, for example, by adjusting the dosage and frequency of …drug until management was optimized...”) in addition see at least [0084] via: “…subtle changes in morphology, for example, QT prolongation in response to medications, .. has been shown to have significant cardiac safety implications”) The Examiner’s BRI interprets “re-determining whether there is the possibility on the basis of the re-acquired electrocardiogram data which is acquired” as recited by the claim to be equivalent to Park’s teaching of iterative titration treatment by adjusting the dosage and frequency of a drug until management was optimized. In medicine the meaning of titrate is to continuously measure and adjust the balance of a physiological function or drug dosage and in this case re-acquiring at an increased or changed dose is part of the action of titrating a dose.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Hunt to incorporate the teachings of Park. Those in the art would have recognized that Hunt’s teaching regarding comparing an electrocardiogram before a drug is applied to a patient to one taken after applying the drug and detecting any changes in the QT interval, commonly computed to determine if there is abnormal QT interval prolongation for a patient could be modified by Park’s teaching reciting a cardiac monitoring system, whereby the cardiac information is detected, recorded and transmitted continuously via a wearable device, and whereby the extracted data features may then be analyzed and used in clinical diagnosis related to the titrated dosage of therapeutic drugs administered to patients. This combination would be very beneficial in obtaining data related to the patient’s heart on a continuous basis in order to monitor any adverse changes related to varying amount of drug dosages applied to a patient.
re-outputting, to the information terminal via the communication controller, information indicating that the dosage can be increased on the condition that the re-determining determines that there is not the possibility. (See at least [0083] via: “… Making this information available in a timely manner during the monitoring period could allow the managing physician to iteratively titrate treatment, for example, by adjusting the dosage and frequency of a novel oral anticoagulant drug (NOAC) until management was optimized...”; in addition see at least [0141] via: “…a system for selective transmission of electrocardiographic signal data from a wearable medical sensor…”; in addition see at least [0160] via: “… Figure 12 is a schematic illustration of … a wearable ECG and/or medical sensor 2002 with transmission capabilities .. in that it includes secondary transmitting devices 2004...”) The Examiner’s BRI interprets “re-outputting, to the information terminal via the communication controller, information indicating that the dosage can be increased on the condition that the re-determining determines that there is not the possibility” as recited by the claim to be equivalent to Park’s teaching of Making information available in a timely manner during the monitoring period based in iterative titration treatment by adjusting the dosage and frequency of a drug until management was optimized. In medicine the meaning of titrate is to continuously measure and adjust the balance of a physiological function or drug dosage and in this case re-outputting at an increased or changed dose is part of the action of titrating a dose.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Hunt to incorporate the teachings of Park. Those in the art would have recognized that Hunt’s teaching regarding comparing an electrocardiogram before a drug is applied to a patient to one taken after applying the drug and detecting any changes in the QT interval, commonly computed to determine if there is abnormal QT interval prolongation for a patient could be modified by Park’s teaching reciting a cardiac monitoring system, whereby the cardiac information is detected, recorded and transmitted continuously via a wearable device, and whereby the extracted data features may then be analyzed and used in clinical diagnosis related to the titrated dosage of therapeutic drugs administered to patients. This combination would be very beneficial in obtaining data related to the patient’s heart on a continuous basis in order to monitor any adverse changes related to varying amount of drug dosages applied to a patient.
specifying a degree of risk of increasing the dosage corresponding to a difference between (i) the electrocardiogram data of the patient who is given the drug at the dosage and (ii) the electrocardiogram data of the patient who is given the drug at the modified dosage. (See at least [0084] via: “…The theme of timely management and/or intervention is certainly evident in situations where clinically significant arrhythmias are observed, for example, asymptomatic second-degree and complete Heart Block, extended pauses, high-rate supraventricular tachycardias, prolonged ventricular tachycaridas, and ventricular fibrillation. For example, the clinical scenario where an extended pause or complete heart block causes Syncope is a particularly significant case where the availability of a timely and dependable monitoring method could reduce or even eliminate the need for in- hospital monitoring of at-risk patients. The theme can also extend to more subtle changes in morphology, for example, QT prolongation in response to medications, which has been shown to have significant cardiac safety implications. Timely awareness of such prolongation could lead, for example, to early termination of clinical studies evaluating drug safety and effectiveness or, alternatively, to adjusting the dosage or frequency as a means to eliminate observed prolongation..”; in addition see at least [0083] via: “…Making this information available in a timely manner during the monitoring period could allow the managing physician to iteratively titrate treatment, for example, by adjusting the dosage and frequency of a novel oral anticoagulant drug (NOAC) until management was optimized. A further example of this management paradigm is for the patient to be notified of asymptomatic AF—either directly by the device through audible or vibration-based alert, through notification from an application connected to the device, or via phone, email or text-message communication from the managing clinician—for the timely application of a “pill in the pocket” for AF management…”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Hunt to incorporate the teachings of Park. Those in the art would have recognized that Hunt’s teaching regarding comparing an electrocardiogram before a drug is applied to a patient to one taken after applying th