DETAILED ACTION
This Office Action is in response to the communication dated 27 April 2026 concerning Application No. 16/754,718 filed on 08 April 2020.
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.
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.
Information Disclosure Statement
The Information Disclosure Statements submitted on 30 October 2025, 29 January 2026, and 06 March 2026 have been acknowledged and considered by the Examiner.
Response to Arguments
Applicant’s arguments dated 27 April 2026 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 independent claim 1 to more distinctly claim the library that is used for diagnostic purposes. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Regarding the Keel reference, Applicant argues that “Keel’s library does not store associations between specific frequencies of low-energy electromagnetic carrier output signals and health conditions as required by claim 1, as amended” (Arguments, p. 5). Applicant further argues that, in Keel, “the health condition is already known before consulting the library,” and therefore that “the library is used to determine how to treat the condition, not to diagnose it” (Arguments, p. 6). The Examiner respectfully disagrees. Examiner and Applicant seem to agree that “the library in Keel maps stimulation parameters to HRV responses” (Arguments, p. 5), and Keel describes wherein the stimulation parameters may include “specific frequencies of low-energy electromagnetic carrier output signals” as recited ([0007], [0029], [0046], for example). In this, Keel describes associations between the output signals and health conditions such as cardiovascular disorders.
Keel further describes “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” ([0074], emphasis added). The Examiner respectfully submits that this is similar to Applicant’s claim of using the library to diagnose a health condition of the patient. Regarding Applicant’s claim that “the health condition is already known before consulting the library,” the Examiner respectfully submits that this is only during the process of building the library, for which the health condition of the patient must be known in order to properly correlate stimulation parameters and HRV responses with medical conditions. However, as stated by Keel, once the “causal relationship” is determined, it can be used “for diagnostic purposes” (quoting from Keel’s [0074] referenced earlier).
Therefore, the Examiner respectfully submits that Keel obviates the use of a library comprising associations between specific frequencies of low-energy electromagnetic carrier output signals and corresponding health conditions in order to provide a diagnosis of a health condition.
Applicant argues that “Pasche does not disclose or suggest that its electromagnetic signals are configured to influence microtubule conductivity” (Arguments, p. 6), continuing that “the mere overlap of frequency ranges does not establish that Pasche’s signals are configured to influence microtubule conductivity” (Arguments, p. 7). In support of this, Applicant cites the Specification at [0307], specifically that “the alternating fields may interfere with polymerizing and depolymerizing electrostatics of microtubules due to the force of the alternating fields acting on the tubulin dimers that make up the microtubules,” and “the tubulin dimers’ dipole moment could be affected by these external fields, especially in mitosis due to decreased shielding.”
As a preliminary matter, the Examiner notes that the features upon which Applicant relies (i.e., interfering with polymerizing and depolymerizing electrostatics, acting on tubulin dimers, etc.) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant is encouraged to recite specifically how the low-energy electromagnetic carrier output signals are configured to influence microtubule conductivity at a plurality of frequencies, at which time the Examiner will address those potential limitations.
The Examiner also respectfully submits that, as Pasche describes amplitude modulated electromagnetic fields that operate within a frequency range that fully encompasses the frequency range described by Applicants in their Specification ([0009] - [0010]), Pasche’s signals would have the same functional properties as the signals described by Applicant. The Examiner respectfully directs Applicant to MPEP 2112.01, which describes, when discussing Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985), that “the court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.” In this case, Pasche describes a system for influencing cellular functions or malfunctions including directly or indirectly influencing cancerous cell growth or proliferation thereof ([0011]), including providing electromagnetic carrier output signals at a specified range of frequencies. The Examiner respectfully submits that providing the output signals at the frequencies described by Pasche in order to influence cell growth or proliferation would result in exposing the patient to a substantially identical output signal as that described by Applicant. Pasche’s signals and Applicant’s signals are directed towards similar functions and are applied to similar locations. Based at least on the Court’s decision noted above, Pasche’s signals must necessarily exhibit the property of influencing microtubule conductivity, in a similar manner to the signals described by Applicant. Therefore, the Examiner respectfully maintains that Pasche obviates the claimed limitation of electromagnetic carrier output signals configured to influence microtubule conductivity.
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 1-8 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), Soykan (US 2006/0013456 A1), and 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 of low-energy electromagnetic carrier output signals that affect heart rate variability in patients having known health conditions and corresponding health conditions, the health condition corresponding to 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 of low-energy electromagnetic carrier output signals that affect the heart rate variability and corresponding health conditions ([0046] - [0047]), the health condition corresponding to 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 limitations of the library storing associations “in patients having known health conditions” and “wherein the low-energy electromagnetic carrier output signals are configured to influence microtubule conductivity at the plurality of frequencies.” Regarding the library comprising associations between output signals and heart rate variabilities in patients having known health conditions, Soykan also describes a system for diagnosing a health condition of a patient, including generating a library based on a population of patients having known health conditions ([0030] - [0033], [0084]). As Soykan is also directed towards diagnosing health condition of the 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 population of patients to generate the library, similar to that described by Soykan, when generating the library described by Keel, as doing so advantageously allows the patient’s profile can be compared with similar profiles in order to derive a more accurate diagnosis.
Regarding the output signals being configured to influence microtubule conductivity, 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 7, Soykan describes wherein the library comprises an intelligent learning library ([0043]).
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]).
Statement on Communication via Internet
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Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to 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 3792
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