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 .
Election/Restrictions
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/17/2026.
Drawings
The drawings are objected to because figure 3-8 are difficult to view in their current format. The figure numbers are nearly unreadable due to the small font used, further features cannot be determined. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the resistor or current transformer, amplifier, gain block, buffer, analog multiplexer, root mean square to DC converter, analog to digital converter and digital attenuator of claim 9 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: line 3 recites “each signal”, this language lacks proper antecedent basis an should read “each of the signals”. Claim 1 lines 25-26 recite “clinician application”, this language lacks proper antecedent basis and should read “the clinician application”. Claim 1 lines 26-27 recite “transmitted patient information”, this language lacks proper antecedent basis and should read “the transmitted patient information”
Appropriate correction is required.
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 6 and 9 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 6 and 9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 6 and 9 each recite “the body of the user”, this is a positive recitation of a human body. Further, as will be discussed in the 112 rejection it is unclear if the user is the same as the patient. Claim amendment suggestions are found in the 112 rejection section below.
Claim Rejections - 35 USC § 112
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 6 and 9 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 6 and 9 each recite “the body of the user”, claims 6 and 9 depends from claim 1 which recites “a body of a patient”. This language is indefinite in that it is unclear if “the user” is the same as “a patient”. For consistency it is suggested that claims 6 and 9 are amended to recite “the body of the patient”.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Siff et al. US 2020/0121925 in view of McDonald US 2020/0282218.i
Regarding claim 1: Siff discloses a pain management system (“electrotherapeutic device”, paragraph 0041 and “to treat pain”, paragraph 0039) comprising:
an electrotherapy device (“electrotherapeutic device”, paragraph 0041), wherein the electrotherapy device is configured to generate a first and second signal (“signal 1”, “signal 2”, figure 3) , wherein each of the signals has a base frequency between 100 Hz to 500KHz (paragraphs 0008, 0024 which are amplified by respective amplifiers; first and second balanced amplifiers, abstract and claim 1ii); the balanced amplifiers minimize the DC component of the first and second signals (paragraph 0007)
form a therapeutic signal configured to reduce pain at a treatment site by simultaneously sending the first signal from a first electrode to a second electrode and sending the second signal from the second electrode to the first electrode, and then simultaneously sending the first signal from the second electrode back to the first electrode and the second signal from the first electrode back to the second electrode, wherein the first signal and the second signal are linearly independent off phase alternating current signals (paragraph 0008 and claim 1);
adjust the therapeutic signal using a feedback system based on impedance changes within a body of a patient (“feedback network”, paragraph 0044, “based on impedance”, paragraph 0007), with the impedance measured across the first and second electrode (paragraph 0044).
Therefore Siff discloses the claimed invention, however Siff does not disclose:
a patient computing device communicatively coupled to the electrotherapy device through a patient facing application, wherein the patient facing application is configured to operate the electrotherapy device, display directions, collect patient information, and display therapy recommendations;
a clinician computing device communicatively coupled to the patient computing device comprising a clinician facing application configured to receive transmitted patient information; and
a patient information database communicatively coupled to the patient computing device and the clinician computing device through the patient facing application and clinician application, wherein the patient information database is configured to receive transmitted patient information, and wherein the patient information database is configured to store and analyze the transmitted patient information, and provides at least one therapy recommendation to a user of the patient computing device through the patient facing application based on the analysis of the transmitted patient information.
However McDonald teaches:
a patient computing device 740 (figure 7) communicatively coupled to the electrotherapy device 602 (figure 7) through a patient facing application (considered to be software, paragraphs 0067, 0073 and 0081) wherein the patient facing application is configured to operate the electrotherapy device 750 (IPG figure 7 and paragraphs 0067, 0073 and 0081), display directions (paragraph 0107), collect patient information (paragraphs 0071, 0105 “user input”, and display therapy recommendations (“therapy suggestions”, paragraph 0107);
a clinician computing device 732 (figure 7) communicatively coupled to the patient computing device (the devices are all coupled via wireless coupling, some are coupled through the closed-loop programming system) comprising a clinician facing application configured to receive transmitted patient information (paragraphs 0102, 0105 and 0106); and
a patient information database 710 (figure 7) communicatively coupled to the patient computing device 740 (figure 7) and the clinician computing device 732 (figure 7) through the patient facing application and clinician application, wherein the patient information database 710 (figure 7) is configured to receive transmitted patient information (received via network 720 from the closed loop programming device, which receives data from both the clinician and patient programmers 732/740), and wherein the patient information database is configured to store and analyze the transmitted patient information (paragraphs 0104 and 0110), and provides at least one therapy recommendation 790 (“therapy suggestions”, figure 7 also paragraph 0107) to a user of the patient computing device through the patient facing application based on the analysis of the transmitted patient information (paragraphs 0104-0107).
It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Siff to include a patient computing device, clinician computing device and patient information data base, as taught by McDonald, in order to utilize a closed-loop feedback system which uses input from a clinician and/or patient as well as a modeling system (McDonald, paragraph 0072).
Regarding claim 2: Siff discloses that the first and second signals can be summed prior to amplification (figure 3: elements 68 and 66 are switches; the signal can be routed to the summing network 64 prior to amplification at 67, figure 3).
Regarding claim 3: Siff discloses the use of Class D switching amplifiers (paragraph s0067-68).
Regarding claim 4: Siff discloses that the therapeutic signal is a linear combination of the first and second signals (claim 3).
Regarding claim 5: Siff discloses that the first and second signals have a frequency difference between 1-400 Hz (abstract “1 Hz and 300 Hz”). iii
Regarding claims 6-7: Siff disclose the feedback system is configured to monitor, across the first and second electrode, a voltage or current associated with body impedance and controls the therapeutic signal in response to impedance changes and utilizes software to determine if the therapeutic signal should be changed based on the current or voltage (paragraphs 0044-45 and 0047-48; software is disclosed in paragraphs 0044-45).
Regarding claim 8: Siff disclose the base frequency for the first and second signals is between 200 Hz-500 KHz (paragraph 0024 and claim 8), which encompasses the claimed range of 200 Hz – 1 KHz.
Regarding claim 9: Siff discloses a resistor or current transformer that monitors a current through the body of the user; an amplifier for differentially detecting a voltage developed by the current passing through the resistor; a gain block for further amplifying the detected voltage; a buffered attenuator for sampling the voltage across the first electrode and the second electrode and setting a value of the voltage to within a predetermined range; an analog multiplexer having as a first input thereto an output of the gain block and having as a second input thereto an output of the buffered attenuator, the analog multiplexer configured to selectively output either the first input or the second input, based on a signal from a CPU; a root mean square (RMS) to DC converter having input thereto for an output of the analog multiplexer, and being configured to output a DC level approximately equal to an RMS value of the therapeutic signal; an analog-to-digital converter (ADC) configured to convert an analog output of the RMS to DC converter into a digital signal for use by a digital attenuator; and the digital attenuator configured to change the DC level, as required by the feedback system (claim 9, while the language is not identical it contains the same components).
Regarding claim 10: Siff discloses a timer to monitor a treatment time set by the user (paragraphs 0063-64).
Regarding claim 11: Siff/McDonald discloses the claimed invention McDonald further teaches that the patient information comprises patient information collected by the electrotherapy device and the patient facing information, and user input patient information entered into the patient facing application (paragraphs 0102, 0108 and 0117). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Siff/McDonald of claim 1 to include patient information collected by the electrotherapy deice based on user input, as taught by McDonald, in order to allow the patient to input parameters important to alter stimulation.
Regarding claim 12: Siff/McDonald discloses the claimed invention McDonald further teaches that the patient information database 710 (figure 7) is configured to provide a therapy recommendation 790 (figure 7) based on an algorithm (paragraphs 0104 and 0110), machine learning model (paragraph s0060 and 0120) and artificial intelligence (paragraph 0104). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Siff/McDonald of claim 1 to include patient information collected by the electrotherapy deice based on user input, as taught by McDonald, in order to algorithms, machine learning and/or AI to assist in analyzing information.
Regarding claim 13: Siff/McDonald discloses the claimed invention McDonald further teaches that the patient facing application is configured to provide a previously stored treatment (paragraph s0096 and 0100, also 714 figure 7). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Siff/McDonald of claim 1 to include patient information collected by the electrotherapy deice based on user input, as taught by McDonald, in order to retain previous treatment programs.
Regarding claim 14: Siff/McDonald discloses the claimed invention McDonald further teaches that the clinician facing application is configured to allow the clinician to send a clinical therapy plan change to the user, through the patient facing application to provide a change in therapy (paragraphs 0067, 0102, 0105 and 0016). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Siff/McDonald of claim 1 to include a clinician updating therapy, as taught by McDonald, in order to provide pain management to the patient.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Siff et al. US 2020/0121925 in view of McDonald US 2020/0282218 and further in view of Srivastava et al. US 2022/0401739.
Regarding claim 15: Siff/McDonald discloses the claimed invention however Siff/McDonald does not disclose the use of patient compliancy information. Srivastava however teaches of a cloud-based system (title and abstract) which includes an external system communicating with an implant, as well as several other device which communicate with the implant either directly or indirectly (figure 1). Srivastava further teaches that the cloud-computing device can determine patient compliance based on received patient data (paragraph 0028), this can include a patient report on their compliance with a daily routine or clinical protocol (paragraph 0117). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Siff/McDonald to use patient compliance data, as taught by Srivastava in order to determine if the patient is folloing a clinical protocol.
Regarding claim 16: Siff/McDonald discloses the claimed invention however Siff/McDonald does not disclose that the patient receives a message based on patient compliance to a therapy plan. Srivastava however teaches that feedback recommendations may be provided to a patient or other authorized user based on patient performance including compliance (paragraph 0144). Srivastava further teaches that the patient can receive notification messages (paragraph 0111). These messages/alerts can include instructing the patient to refrain from engaging in pain causing activities (paragraph 0143). The patient can also be alerted based on compliance (paragraph 0149). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Siff/McDonald to include messages sent to a patient to increase compliance, as taught by Srivastava in order to aid the patent in treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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 H Layno can be reached 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 (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i Regarding the Siff et al. US 2020/0121925 reference: it is acknowledge that there is a common Assignee and common inventors between the pending application (18/422,869) and the prior art in this rejection. However, the US 2020/0121925 disclosure does qualify as prior art because it was published on 4/23/2020 which is more than a year after the priority date of 1/26/2023 for this application.
ii These are considered to be overlapping ranges, see MPEP 2144.05
iii These are considered to be overlapping ranges, see MPEP 2144.05
Prosecution Insights