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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06 October 2025 has been entered.
Status of Claims
Claims 1-8 are pending and currently under consideration for patentability; claim 1 has been amended; claims 9-42 previously were cancelled.
Response to Arguments
Applicant’s arguments dated 06 October 2025 have been fully considered, but they are not persuasive or 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.
Applicant has amended the independent claim to recite identifying frequencies that produce a statistically significant change in heart rate variability and wherein the library comprises associations between specific frequencies that affect heart rate variability and corresponding health conditions. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Applicant argues that “Keel’s system maps stimulation parameters to HRV responses for therapeutic control of spinal cord stimulation, not for diagnostic identification of health conditions base on frequency-specific HRV changes” (Arguments, p. 5). The Examiner respectfully disagrees and directs Applicant to Keel’s paragraphs [0046] - [0047], which describe the use of cardiac parameters and stimulation settings for diagnostic purposes ([0046]: “the device may also record diagnostics and generate warnings…if the device tracks and stores R-R intervals, the SCS device thereby serves as an implantable loop recorder to provide diagnostic information to the clinician”; [0047]: “a system and method is set forth that can sense R-waves independent of a cardiac pulse generator for providing closed-loop therapeutic procedures that sense cardiac electrical activity and use the detected R-waves as feedback diagnostics of arrhythmias and heart conditions…with the ability to sense R-waves, the SCS device can build a map/atlas/library of HRV parameters corresponding to different tested stimulation configurations”). Therefore, the Examiner respectfully maintains that Keel’s system may use heart rate variability and stimulation settings for diagnostic purposes.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hoium et al. (US 2003/0139678 A1) in view of Keel et al. (US 2014/0277278 A1), further in view of Pasche et al. (US 2010/0042168 A1).
Regarding claim 1, Hoium describes a system for diagnosing a health condition of a patient ([0010]) comprising
an electrocardiogram monitoring system ([0092]) configured to detect, measure and store a plurality of first values for heart rate variability values exhibited by the patient ([0094] - [0095]) during a basal or non-exposure period ([0103], [0134]) and a plurality of second values for heart rate variability values exhibited by the patient during or after an exposure period ([0103], [0134]) in which the patient is exposed to low-energy electromagnetic carrier output signals ([0092], low-level electromagnetic energy)
an electrically powered generator ([0092], electronics interface 18 coupled to computer 27, for example) adapted to be actuated to generate the low-energy electromagnetic carrier output signals ([0092]: “The electronics interface 18, by coupling with computer 27, allows for the injection of low-level electromagnetic energy into patient 35 to alter at least one cardiac signal. The energy is delivered at a subpacing threshold and is typically introduced externally, through patient 35's chest and into cardiac tissue.”) for exposing or applying the low-energy electromagnetic carrier output signals to the patient during the exposure period ([0092]: “The subpacing energy is delivered just before a QRS complex event…the energy delivery leads are typically leads 7 and 8…”)
a processing system configured to synchronize the electrocardiogram monitoring system and the electrically powered generator ([0137] describes the software and circuitry of electronic interface 18; [0180] - [0181] describe the synchronization means and delivering stimulation that is synchronous with the R-wave)
Regarding claim 1, Hoium does not explicitly disclose wherein the low-energy electromagnetic carrier output signals comprise a plurality of frequencies, wherein the low-energy electromagnetic carrier output signals are configured to influence microtubule conductivity at the plurality of frequencies, and wherein the plurality of second values for heart rate variability values exhibited by the patient in connection with the exposure period are associated with a corresponding frequency of the plurality of frequencies for the low-energy electromagnetic carrier output signals. Hoium also does not explicitly disclose wherein the processing system is configured to determine which of the plurality of frequencies affect the heart rate variability of the patient based on a comparison of the plurality of first values and the plurality of second values by identifying frequencies that produce a statistically significant change in heart rate variability, and retrieve, from a library comprising associations between specific frequencies that affect heart rate variability and corresponding health conditions, the health condition with which the identified frequencies that affect the heart rate variability of the patient are associated to provide a diagnosis of the health condition.
However, Keel also describes a system for diagnosing a health condition of a patient ([0047]), including delivering signals at a plurality of frequencies ([0029], [0046]) and wherein a plurality of heart rate variability values exhibited by the patient in connection with the delivered signals are associated with a corresponding frequency of the plurality of frequencies for the delivered signals ([0046], the device derives parameters representative of cardiac rhythm such as HRV parameters, the device correlates the parameters representative of cardiac rhythm with neurostimulation control parameters to map neurostimulation control settings to the cardiac rhythm parameters; [0048], generating correlation databases). Keel further describes wherein the processing system is configured to determine which of the plurality of frequencies affect the heart rate variability of the patient based on a comparison of the plurality of first values and the plurality of second values ([0029], the SCS device delivers neurostimulation during or after cardiac signals are sensed in order to map the effects of the stimulation on cardiac parameters; [0046], at step 102, the device derives parameters representative of cardiac rhythm such as heart rate variability, at step 104, the device correlates the parameters representative of cardiac rhythm with neurostimulation control parameters to map neurostimulation control settings to the cardiac rhythm parameters), and retrieve, from a library comprising associations between specific frequencies that affect the heart rate variability and corresponding health conditions ([0046] - [0047]), the health condition with which the identified frequencies that affect the heart rate variability of the patient are associated to provide a diagnosis of the health condition ([0046], “various tables may be generated that relate particular combinations of SCS control parameters to particular HRV parameters…to thereby provide an atlas or library of information for guiding or tuning further adjustments to the SCS control parameters”…“the SCS device controls the delivery of further neurostimulation based on the mapping of neurostimulation control settings to cardiac rhythm parameters to address arrhythmia, ischemia, heart failure or other disorders…may also record diagnostics and generate warnings…the SCS device thereby serves as an implantable loop recorder to provide diagnostic information to the clinician”; [0074], “determining a causal relationship within the patient between neural activity and arrhythmias or other cardiovascular disorders, which may be helpful for detecting or predicting disorders, controlling proactive neurostimulation or for diagnostic purposes”).
As Keel is also directed towards diagnosing a health condition of a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a plurality of signal frequencies and correlate the heart rate variability values with the frequencies, similar to what is described by Keel, when using the system described by Hoium, as doing so advantageously allows the resulting system to better monitor and warn a user or a healthcare provider of a potentially adverse event (Keel: [0046] - [0047]).
Specifically regarding the limitation of identifying frequencies that produce a statistically significant change in heart rate variability, Keel describes tracking the HRV values, including setting a target HRV value and adjusting stimulation parameters in order to achieve the target HRV value ([0059], [0062]). Based on this, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to identify those frequencies that produce a statistically significant change in heart rate variability, as recited, as doing so advantageously allows the resulting method to modify the stimulation parameters, if needed, in order to achieve a target HRV value.
Hoium in view of Keel suggests the system of claim 1 with the exception of not disclosing the limitation of “wherein the low-energy electromagnetic carrier output signals are configured to influence microtubule conductivity at the plurality of frequencies.” However, Pasche also describes a system configured to apply low-energy signals to a patient, including wherein the low-energy signals are amplitude modulated and comprise a plurality of frequencies ([0014]). Pasche further describes the use of frequencies in a range of 0.01 Hz to 150 kHz ([0014]), which fully encompass the range of frequencies described by Applicant as influencing microtubule conductivity (Applicant’s Specification at [0009] - [0010] describes frequencies in the range of 10 Hz to 1,000 Hz as influencing microtubule activity). As Pasche is also directed towards providing low-energy signals to a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a frequency range similar to that described by Pasche when using the system described by Hoium and Keel, as doing so allows the resulting signal to appropriately target the proper cell types and generate the corresponding responses from the patient. Although Applicant has not recited a range of frequencies that is capable of influencing microtubule activity, the range described in Applicant’s Specification as being capable of performing this function lies inside the range disclosed by the prior art. As a result, the Examiner respectfully submits that a prima facie case of obviousness exists (please see MPEP 2144.05).
Regarding claim 2, Hoium describes wherein the processing system is internal to the electrocardiogram monitoring system ([0179] - [0180]).
Regarding claim 3, Hoium describes wherein the processing system is external to the electrocardiogram monitoring system ([0179], [0181]).
Regarding claim 4, Hoium describes wherein the processing system is configured to sense and identify one or more of a specific electromagnetic field frequency (Hoium: [0145] and descriptions of wavelet decomposition analysis), and Pasche describes wherein the frequency is an amplitude modulated frequency ([0014]).
Regarding claim 5, Hoium describes an interface controller in operable communication with the electrocardiogram monitoring system and the electrically powered generator ([0091]).
Regarding claim 6, Hoium describes wherein the electrocardiogram monitoring system is configured to measure one or more R-R interval values ([0134]), calculate one or more heart rate variability values (0095]), or record one or more heart rate variability values ([0095]).
Regarding claim 8, Pasche describes wherein the low-energy electromagnetic carrier output signals comprise an amplitude modulation frequency in a range from about 0.01 Hz to about 150 kHz ([0014]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hoium in view of Keel and Pasche, further in view of Vezina (US 2014/0278478 A1).
Regarding claim 7, Hoium in view of Keel and Pasche suggests the system of claim 1, but Hoium, Keel, and Pasche do not explicitly disclose wherein the library comprises an intelligent learning library. However, Vezina also describes a system for managing health data, including diagnosis data, of a patient ([0059]), including the use of an intelligent learning library ([0094]). As Vezina is also directed towards managing patient data and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate an intelligent learning library similar to that described by Vezina when using the system described by Hoium, Keel, and Pasche, as doing so advantageously allows the resulting system to more accurately and autonomously correlate a patient’s measured heart rate variability values to known values indicative of healthy or non-healthy conditions.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796