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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 11, 2025 has been entered.
Response to Amendment
This non-FINAL office action is in response to the amended claims filed on July 11, 2025.
Claims 1-3, and 10-20 have been previously canceled in the Election dated 06 February 2024.
Claims 4-9 and 96-104 have been amended.
Claims 105-109 are newly added.
Claims 4-9 and 96-109 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 11, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Claims 4, 98 and 105 recite the following limitations:
“a communication module configured to wirelessly transmit an alert signal to a remote therapeutic monitoring system…”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner has reviewed the disclosure and determined that it fails to provide sufficient structure for the following elements:
The specification merely restates the claims language and defines the communication module by what it does, without properly reciting any structure (see [0294], [0667], [0690]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-9 and 96-109 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 4, 98 and 105 recite:
“a communication module configured to wirelessly transmit an alert signal to a remote therapeutic monitoring system…”
The noted above limitations have been interpreted to invoke 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for performing the claimed function evidencing that the Applicant was not in possession of the claimed invention at the time of filing. Claims 5-9, 96-97, 99-104, and 106-109 are rejected due to dependency.
Claims 4, 98, and 105 further recite “a remote therapeutic monitoring system” that receives an alert from the communication module and generates treatment modification/instruction signal. The Specification does not provide sufficient support for the remote therapeutic monitoring system. [0344] discloses that the alert is sent to the patient, caregiver, or provider. It is unclear if the Applicant intends to define the remote therapeutic monitoring system by the people whom the alert is being sent to. Claims 5-9, 96-97, 99-104, and 106-109 are rejected due to dependency.
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 4-9 and 96-109 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 4, 98 and 105 recite:
“a communication module configured to wirelessly transmit an alert signal to a remote therapeutic monitoring system …”
The above limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. [0294], [0667], [0690] of the Specification merely restates the claim language and defines the communication module by what it does, without properly reciting any structure or linking and associating the noted module to a specific structure or computer. Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 5-9, 96-97, 99-104, and 106-109 are rejected due to dependency.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 5 recites the limitation "wherein the at least one physiological change" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 105 recites the limitation "sweat chemistry sensor" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 102 recites the limitation "where the analysis" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 103 recites the limitation "wherein the analysis" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 105 is/are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Cooney et al. (US 20180365385 A1), hereinafter Cooney
Regarding claim 105, Cooney teaches a device for remotely monitoring a patient, comprising:
a wearable electronic device having one or more biometric sensors, wherein at least one of the one or more biometric sensors is a chemical sensor configured to detect a chemical physiological change in response to a therapeutic treatment ([0016] discloses collecting data from a medical monitoring device including wearable device (e.g., physiological data, biomarker data, neurofeedback, etc.) regarding a patient’s reaction to a medication) ([0048] discloses a change in measurement of patient’s glucose level indicates the patient’s glucose level has decreased as a direct effect of medication).;
a microprocessor operatively coupled to the sweat chemistry sensor to receive sensor data indicative of the chemical physiological change, and determine whether a concerning-condition threshold has been met indicating that the patient may have a concerning-condition related to the therapeutic treatment ([0017] discloses the feedback information is received by the system and regularly/automatically evaluated by the computing system using one or more algorithms and/or mathematical models to detect parameters and/or patterns indicative of a clinically significant reaction. ([0044] discloses the one or more medical monitoring devices can include a device configured to determine physiological information about the user based on detection of one or more biomarkers included in sweat generated by the patient.);
a communication module configured to wirelessly transmit an alert signal to a remote therapeutic monitoring system based on data from the one or more biometric sensors, the alert signal indicating that the concerning-condition threshold has been met, and further configured to receive, in response to the alert signal, ([0034] discloses communication hardware and software to facilitate wireless communication between client device and other devices such as medical management service provider, or monitoring device. [0017] discloses notifications can be automatically generated and sent to patients, the patient’s physicians, etc., identifying the clinical significant reaction, and further configured to receive, in response to the alert signal, a treatment instruction signal generated by the remote therapeutic monitoring system based on the alert signal ([0019] discloses notifications from the server instructing the patient regarding a change to the patient’s medication regimen determined based on the side effect)).
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 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 nonobviousness.
Claim(s) 4, 9, 96-97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (WO2020023954A1), hereinafter Heikenfeld, in view of Cooney et al. (US 20180365385 A1), hereinafter Cooney et al.
Regarding claim 4, Cooney teaches a device for indicating patient adherence to a prescribed drug-taking regimen ([0005] discloses determining patient compliance with a drug regimen), comprising
a wearable diagnostic device comprising one or more biometric sensors ([0044] discloses a wearable biofluid sensing device which may include a plurality of sensors to detect biofluid analytes), wherein at least one of the one or more biometric sensors is a sweat chemistry sensor ([0044] discloses the sensor may be a sweat sensor) configured as a patch adherable to the skin of the patient ([0047] discloses the sensing device may be in the form of a patch to reliably collect sweat) to automatically detect a chemical physiological indicator selected from the group consisting of the drug, a metabolite of the drug, or a chemical biometric indicator co-administered with the drug as part of a therapeutic treatment ([0002] discloses the analytes measured by the wearable device can include the drug itself, a tracer, a metabolite of the drug, a biomarker for a relevant physical condition, or other analyte.), where the chemical physiological indicator is water-soluble and detectable in the sweat of the patient ([0002] discloses the tracer or metabolite of the tracer emerges in sweat);
a microprocessor operatively coupled to the sweat chemistry sensor to receive sensor data indicative of the presence of the physiological indicator, and determine whether a compliance threshold has been met indicating that the patient ingested the drug within a prescribed dosing interval; and ([0045] discloses the biofluid sensing device includes computing and data storage capability to conduct communication, data aggregation, and execute algorithms, and generate notifications. [0041] discloses drug detection threshold that shows the primary drug is present in the blood or organ with reasonable certainty. [0067] discloses drug co-administered with tracer that has a longer half-life than the interval between doses will indicate patient compliance); and
a communication module configured to wirelessly transmit an alert signal to a remote therapeutic monitoring system based on data from the one or more biometric sensors, the alert signal indicating that the patient is in compliance with the prescribed-taking regimen ([0071] discloses the device issues an alert based on monitoring of a patient’s sweat. The device could transmit the signal to an ancillary device of a caregiver or provider or patient.) ([0080] discloses communication between a wearable sensing device worn by the patient and a provider base (interpreted as the therapeutic monitoring system since the Specification discloses alerts being sent to patients, caregivers, providers, etc.) and further configured to receive, in response to the alert signal, a treatment instruction signal generated by the remote therapeutic monitoring system based on the alert signal ([0071] discloses the device could be configured to monitor treatment efficacy, or the prevalence of side-effects, and alert the provider to switch medication or lower the dosage),
Heikenfeld may not explicitly teach the following limitations; however, Cooney teaches:
wherein the alert signal causes a display to indicate to the patient a modification to the drug taking regimen based on the data.
([0017] discloses using one or more algorithms to detect parameters/patterns in the feedback information to determine if an adjustment to the patient medication regimen is needed. Notifications can be automatically generated and sent to patients, patient’s physicians, etc., the notifications can also provide a recommended action to perform (e.g., stopping usage of the medication, changing the dosage of the medication, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the device of Heikenfeld to include an alert displaying to the patient to indication a modification to their drug taking regimen as taught by Cooney in order to reduce medication side effects and provide relevant information to the patient more efficiently.
Regarding claim 9, Heikenfeld/Cooney teach the device according to claim 4. Heikenfeld further teaches
an on-demand sweat stimulator for stimulating the production of sweat by the patient ([0047] discloses sweat can be stimulated in conjunction with use of a sensing device such as patches, bands, straps, wearables, etc. that brings sweat stimulation).
Regarding claim 96, Heikenfeld/Cooney teaches the device according to claim 4. Cooney further teaches wherein the at least one or more biometric sensors includes a chemical biosensor for detecting a target analyte from a fluid biosample (Cooney [0044] discloses the one or more medical monitoring devices can be an implantable cardioverter-defibrillator (ICD) that can sense biomarkers in bodily fluids), wherein the chemical biosensor detects a target analyte expressed by the patient's body in response to the therapeutic treatment ([0016] discloses detecting change in biomarker data in response to medication).
Regarding claim 97 Heikenfeld/Cooney teaches the device according to claim 96. Cooney further teaches where the target analyte is indicative of a concerning physiological change ([0048] discloses a change in measurement of patient’s glucose level indicates the patient’s glucose level has decreased as a direct effect of medication).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (WO2020023954A1), hereinafter Heikenfeld, in view of Cooney et al. (US 20180365385 A1), hereinafter Cooney et al., and further in view of Gura et al. (US 20100022936 A1), hereinafter Gura.
Regarding claim 5, Heikenfeld/Cooney teach the device according to claim 4 as shown above. Cooney further teaches wherein the at least one physiological change includes an indication of a change in the cardiovascular condition ([0044] discloses the one or more medical monitoring device can be an implantable cardioverter-defibrillator that is configured to perform functions of an ICD (monitoring change in heart rhythm) and additional sensing of biomarkers in bodily fluids).
Heikenfeld/Cooney may not explicitly teach the following limitations; however, Gura teaches:
wherein the therapeutic treatment includes an anticoagulant medicinal drug for treating a cardiovascular condition ([0010] discloses a wearable ultrafiltration device for treating CHF (congestive heart failure). [0013] discloses the ultrafiltration device includes an anticoagulant reservoir from which anticoagulants are infused into the blood).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the device of Heikenfeld/Cooney to include an anticoagulant treatment for treating a cardiovascular condition as taught by Gura in order to prevent blood coagulation while allowing for convenient, continuous, steady and smooth treatment of CHF (Gura, [0010], [0027]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (WO2020023954A1), hereinafter Heikenfeld, in view of Cooney et al. (US 20180365385 A1), hereinafter Cooney et al., and further in view of Potts et al. (WO2009025698A1), hereinafter Potts.
Regarding claim 6, Heikenfeld/Cooney teach the device according to claim 4 as shown above. Heikenfeld/Cooney do not teach the following limitation; however, Potts teaches wherein the sweat chemistry sensor includes a collection surface having a hydrophobic and hydrophilic channels for directing the sweat to a detection area of the sweat chemistry sensor ([0010] discloses the sweat collection device may comprise a gradient comprising at least one hydrophilic portion and at least one hydrophobic portion which assist in the collection of sweat, as sweat is typically more attracted to the hydrophilic portion than to the hydrophobic portions).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the sweat chemistry sensor of Heikenfeld/Cooney to include hydrophilic and hydrophobic channels to direct sweat collection as taught by Potts in order to maximize sweat collection for biomarker detection without requiring extra energy input (Potts, [0008])
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (WO2020023954A1), hereinafter Heikenfeld, in view of Cooney et al. (US 20180365385 A1), hereinafter Cooney et al., in view of Lee et al. (US 20100022902 A1), hereinafter Lee, and further in view of Kiefer (US 20080104006 A1).
Regarding claim 7, Heikenfeld/Cooney teaches the digital therapeutic device according to claim 4 as shown above. Heikenfeld/Cooney do not explicitly teach the following limitations; however, Lee teaches wherein the microprocessor applies probabilistic methods to determine if at least one physiological change threshold has been exceeded ([0005] discloses sensing at least one physiological signal in a patient’s body received in an implantable medical device and monitoring a corresponding physiological parameter to detect deviations from normal, desired or expected);
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the device of Cooney to include detecting deviations from the norm as taught by Lee in order to detect medical conditions accurately and rapidly and delivering appropriate therapy more efficiently (Lee, [0020]).
Heikenfeld/Cooney/Lee do not teach the following limitations; however, Kiefer teaches wherein the probabilistic analysis comprises determining from a data set of one or more biometric parameters whether the data set is acceptable for deciding that the at least one physiological change threshold has been exceeded ([0012] discloses a method of deciding whether a data set is acceptable for making a decision).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the statistical analysis of Lee to include determining if a dataset is acceptable as taught by Kiefer in order to improve accuracy in decision making.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (WO2020023954A1), hereinafter Heikenfeld, in view of Cooney et al. (US 20180365385 A1), hereinafter Cooney et al., in view of Lee et al. (US 20100022902 A1), hereinafter Lee, in view of Kiefer (US 20080104006 A1) as applied to claim 7 above, and further in view of Volosin et al. (US 20190358464 A1), hereinafter Volosin.
Regarding claim 8, Heikenfeld/Cooney/Lee/ Kiefer teach the device according to claim 7 as shown above. Heikenfeld/Cooney/Lee/Kiefer may not explicitly teach the following limitations; however, Volosin teaches: wherein the probabilistic analysis further comprises applying a statistical weighting to each of the one or more biometric parameters, where the statistical weighting is dependent on a predetermined value of a ranking of importance in detecting each of the at least one physiological change for said each of the one or more biometric parameters relative to others of the one or more biometric parameters ([0204]-[0205] discloses outputting a normalized score of the received parameters from the wearable device to evaluate a patient’s condition and adjust treatment accordingly. The parameters are weighted to determine which parameters most affects the score).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the statistical analysis of Lee/Kiefer to include applying weights to the biometric parameters as taught by Volosin in order to make accurate medical decisions in evaluating a patient’s condition and adjusting treatment according to the measured parameters (Volosin, [0204]).
Claim(s) 98-100 are rejected under 35 U.S.C. 103 as being unpatentable over Cooney et al. (US 20180365385 A1), hereinafter Cooney, in view of Dennis et al. (US 20070224128 A1), hereinafter Dennis.
Regarding claim 98, Cooney teaches a device for indicating a patient compliance with a prescribed drug taking regimen, comprising:
a wearable electronic device having one or more biometric detectors each for detecting one or more biometric parameters, wherein the biometric parameters are dependent on at least one physiological change in response to an administration of a medicinal drug to the patient in accordance with the prescribed taking regimen ([0016] discloses collecting data from a medical monitoring device including wearable device (e.g., physiological data, biomarker data, neurofeedback, etc.) regarding a patient’s reaction to a medication) and wherein the at least one physiological change includes the presence or concentration of a chemical analyte or metabolite resulting from the administered medicinal drug ([0016] discloses detecting change in biomarker data in response to medication) ([0048] discloses a change in measurement of patient’s glucose level indicates the patient’s glucose level has decreased as a direct effect of medication).;
a microprocessor for receiving the one or more biometric parameters and determining if at least one physiological change threshold has been exceeded dependent indicating that the medicinal drug has been administered to the patient ([0017] discloses the feedback information is received by the system and regularly/automatically evaluated by the computing system using one or more algorithms and/or mathematical models to detect parameters and/or patterns indicative of a clinically significant reaction);
a communication module configured to wirelessly transmit an alert signal to a remote therapeutic monitoring system ([0034] discloses communication hardware and software to facilitate wireless communication between client device and other devices such as medical management service provider, or monitoring device.)
Cooney may not explicitly teach the following limitations; however, Dennis teaches:
the alert signal indicating that the patient is in compliance with the prescribed drug-taking regimen ([0055] discloses providing results regarding subject compliance to the user which includes the physician or subject (interpreted to be the monitoring system as per the specification)), and further configured to receive, in response to the alert signal, a treatment instruction signal generated by the remote therapeutic monitoring system based on the alert signal ([0060] discloses providing an alert to the user/subject regarding prescribed time and dosage of the drug to be taken based on analysis of drug blood concentration. [0061] discloses recommending an intervention (such as canceling, altering, maintain, or adding to the prescription regimen) to ensure continued subject health).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the device of Cooney to include a communication module to send and receive alerts to ensure drug compliance and patient health and safety.
Regarding claim 99, Cooney/Dennis teach the device according to claim 98. Dennis further teaches wherein the microprocessor is further configured to: analyze the one or more biometric parameters using probabilistic methods to detect deviations from pre- determined physiological norms ([0059] discloses the processing unit is configured for conducting a comparison of data regarding recommended marker levels for a prescribed drug regimen against monitored drug marker data in subject breath samples to determine if there are any deviations from prescribed drug, dosage, or duration ranges for the drug).
Regarding claim 100, Cooney/Dennis teach the device according to claim 99. Cooney/Dennis further teach wherein the microprocessor is further configured to: adjust an applied therapy treatment based on the detected deviations in biometric parameters (Dennis [0022] discloses deviations outside of a given concentration (thus pharmacological efficacy of the drug) would be automatically flagged so that a user could appropriately adjust the drug dosage per suggestions provided by a computer processing unit connected to the sensor.); and generate predictive feedback by comparing both initial and subsequent biometric values to historical data, refining the indication of the concerning physiological change in response to detected trends over time (Cooney [0017] discloses using one or more algorithms to detect parameters/patterns in the feedback information to determine if an adjustment to the patient medication regimen is needed.).
Claim(s) 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooney et al. (US 20180365385 A1) in view of Dennis et al. (US 20070224128 A1), hereinafter Dennis, and further in view of Fuerst et al. (US 20060036619 A1), hereinafter Fuerst.
Regarding claim 101, Cooney/Dennis teach the device according to claim 98. Cooney further teaches wherein the action includes transmitting data dependent on at least one of the physiological change and the biometric parameters of an individual patient to at least one remote server for receiving patient identifying data by a trusted receiver ([0018] discloses providing information to a server device in response to receiving patient first information, the server device configured to store the information in a reaction log for the patient and provide access to authorized users) and for
Cooney/Dennis do not explicitly teach the following limitations; however, Fuerst teaches:
aggregating data received from multiple patients without patient identifying data ([0092] discloses combining data from specifically designed sensors for bio-agents, de-identified personal health records), and analyzing the biometric data using probabilistic methods to detect deviations from pre-determined physiological norms based on data received from the individual patient and from the multiple patients ([0082] discloses analyzing patient specific data and calculating a probability or indication representing a deviation from a normal situation based on larger populations).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the device as taught by Cooney/Dennis to include aggregating data from multiple patients and determining if the patient’s data deviates from the norm based on group data as taught by Fuerst in order to “enhance the accuracy, speed, and cost effectiveness of diagnosing diseases and detecting abnormalities” (Fuerst, [0008]).
Claim(s) 102 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooney et al. (US 20180365385 A1) in view of Dennis et al. (US 20070224128 A1), hereinafter Dennis, and further in view of Kiefer (US 20080104006 A1).
Regarding claim 102, Cooney/Dennis teach the device according to claim 98. Cooney does not explicitly teach the following limitation; however, Kiefer teaches: wherein the analysis comprises determining from a data set of the one or more biometric parameters whether the data set is acceptable for deciding that the at least one physiological change threshold has been exceeded ([0012] discloses a method of deciding whether a data set is acceptable for making a decision).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the statistical analysis of Dennis to include determining if a dataset is acceptable as taught by Kiefer in order to improve accuracy in decision making.
Claim(s) 103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooney et al. (US 20180365385 A1) in view of Dennis et al. (US 20070224128 A1), hereinafter Dennis, and further in view of Volosin et al. (US 20190358464 A1), hereinafter Volosin.
Regarding claim 103, Cooney/Dennis teach the device according to claim 98. Cooney/Dennis does not explicitly teach the following limitation; however Volosin teaches wherein the analysis further comprises applying a statistical weighting to each of the one or more biometric parameters, where the statistical weighting is dependent on a predetermined value of a ranking of importance in detecting each of the at least one physiological change for each biometric parameter relative to others ([0204]-[0205] discloses outputting a normalized score of the received parameters from the wearable device to evaluate a patient’s condition and adjust treatment accordingly. The parameters are weighted to determine which parameters most affects the score).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the statistical analysis of Dennis to include applying weights to the biometric parameters as taught by Volosin in order to make accurate medical decisions in evaluating a patient’s condition and adjusting treatment according to the measured parameters (Volosin, [0204]).
Claim(s) 104 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooney et al. (US 20180365385 A1), hereinafter Cooney, in view of Dennis et al. (US 20070224128 A1), hereinafter Dennis, and further in view of Emaminejad et al. (US 20180070870 A1), hereinafter Emaminejad.
Regarding claim 104, Cooney/Dennis teaches the device according to claim 98, wherein at least one of the biometric values is determined from one or more water-soluble molecules ([0044] discloses the medical monitoring device can include blood-sampling sensor such as glucose meters, an implantable cardioverter-defibrillator that can sense biomarkers in bodily fluids, a urinary catheter that is worn by the user to detect biomarkers in the urine, a blood testing device worn by the patient to detect glucose levels, electrolyte levels, etc.), and […] and wherein the chemical biosensor comprises a sweat chemistry sensor for sensing the one or more water soluble molecules ([0044] discloses the medical monitoring device can include a device to determine physiological information about the user based on detection of one or more biomarkers included in sweat generated by the patient).
Cooney does not explicitly teach the following limitations; however, Emaminejad teaches:
further comprising an on-demand sweat stimulator for stimulating the production of sweat by the patient ([0006] discloses an autonomous wearable sweat extraction and analysis platform that periodically induces sweat with the aid of the iontophoresis process and simultaneously and selectively measures a panel of target analytes in the extracted sweat).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the device of Cooney/Dennis to include an on-demand sweat stimulator as taught by Emaminejad in order to “enable sufficient sweat extraction to provide accurate results” (Emaminejad, [0004]) and “enable a broad range of non-invasive diagnostic and health monitoring applications” (Emaminejad, [0006]).
Claim(s) 106 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooney et al. (US 20180365385 A1), hereinafter Cooney, in view of Heikenfeld et al. (WO2020023954A1), hereinafter Heikenfeld.
Regarding claim 106, Cooney teaches the device according to claim 105, where at least one of the one or more biometric sensors is a sweat chemistry sensor ([0044] discloses the one or more medical monitoring devices can include a device configured to determine physiological information about the user based on detection of one or more biomarkers included in sweat generated by the patient). Cooney does not explicitly teach that the sweat sensor is configured as a patch adherable to the skin of the patient; however, Heikenfeld teaches ([0047] discloses the sensing device may be in the form of a patch to reliably collect sweat) to automatically detect a chemical physiological indicator selected from the group consisting of the drug, a metabolite of the drug, or a chemical biometric indicator co-administered with the drug as part of a therapeutic treatment ([0002] discloses the analytes measured by the wearable device can include the drug itself, a tracer, a metabolite of the drug, a biomarker for a relevant physical condition, or other analyte.), where the chemical physiological indicator is water-soluble and detectable in the sweat of the patient ([0002] discloses the tracer or metabolite of the tracer emerges in sweat).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the chemistry sweat sensor of Cooney to include a as a patch as taught by Heikenfeld in order to use a convenient and non-invasive diagnostic tool to measure biomarkers.
Claim(s) 107-109 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooney et al. (US 20180365385 A1), hereinafter Cooney, in view of Lee et al. (US 20100022902 A1), hereinafter Lee.
Regarding claim 107, Cooney teaches the device according to claim 105. where the wearable diagnostic device applies the therapeutic treatment ([0044] discloses the monitoring device may be an implantable cardioverter-defibrillator), Cooney does not teach the following limitations; however, Lee teaches and where the treatment modification signal causes an adjustment to the therapeutic treatment ([0022] discloses IMDs used as therapeutic and monitoring devices where the sensed information may be used directly by the IMD to adjust or control the therapy delivered to the patient).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to be motivated to modify the device of Cooney to include detecting deviations from the norm and adjusting the therapy in response as taught by Lee in order to detect medical conditions accurately and rapidly and delivering appropriate therapy more efficiently (Lee, [0020]).
Regarding claim 108, Cooney/Lee teaches the device according to claim 107. Lee further teaches where the therapeutic treatment comprises an electroceutical treatment ([0024] discloses delivering pacing pluses to a patient’s heart).
Regarding claim 109, Cooney/Lee teaches the device according to claim 108. Lee further teaches where the one or more biometric sensors comprises a wearable electronic having a skin contact electrode configured to apply the electroceutical treatment and to detect a non-chemical physiological change ([0024] discloses the IMD is coupled to electrical leads and physiological sensors. [0027] discloses leads can be above or below the skin for deriving one or more heart rate related parameters).
Response to Arguments
35 U.S.C. 101 REJECTION OF CLAIMS 4-9
Regarding the rejection of claims 4-9 and 96-104, Applicant has amended the independent claims such that they are now directed to a physical device and not an abstract idea. As such, the 101 rejection has been withdrawn.
35 U.S.C. 102 and 103 REJECTION OF CLAIMS 4-9 and 96-104
Regarding the prior art rejection, Applicant’s arguments with respect to claim(s) 4-9 and 96-104 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.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
Irazoqui et al. (US 20190247664 A1) teaches: System for Wireless Recording and Stimulating Bioelectric Events.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALAK M NASSER whose telephone number is (703)756-4610. The examiner can normally be reached M-F 8:00 AM-5:00 PM.
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/MALAK M NASSER/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687