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
Newly submitted claim 21 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 21 is a stand alone patient and clinician device which are components of the already claimed invention. However, they do not require all of the limitations of the previously examined invention and are considered to be separate and distinct. The device in claim 21 could be for electrotherapy or it could be for some other type of therapy and belongs in a separate class/subclass.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 21 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
The drawing objections, claim objections, 35 USC 101 rejections and the 35 USC 112 rejections are withdrawn in light of the claim amendments received.
Applicant's arguments filed 7/29/20226 have been fully considered but they are not persuasive.
On pages 10-12, regarding item 1, applicant argues that the McDonald’s disclosure does not teach that the Clinician Interaction Computing Device 730 (figure 7) does not receive transmitted patient information. The specific claim language reads:
“a clinician computing device communicatively coupled to the patient computing device comprising a clinician facing application configured to receive transmitted patient information”.
This claim language specifically requires that the clinician computing device is configured to receive transmitted patient data. What needs to be shown in the reference is that the clinician computing device is capable of receiving transmitted data, the configuration would be a telemetry circuit. What data is received or transmitted is considered to be functional language and does not add any additional structure. Any telemetry circuit which can receive data is capable of receiving transmitted patient information. It is noted that the clinician interaction computing device is figure number 730 in figure 7 with a user interface as 742. As is shown in figure 7 the clinician interaction computing device 730 has wireless communication to the closed loop programming system 602, this is a strong indication that telemetry is bi-directional thus the clinician interaction computing device is configured to send and receive data. Further paragraph 0085 of McDonald demonstrates that the external, non-implantable devices allow for the user to communicate with the implantable system, supporting bi-directional telemetry. Further specified in paragraph 0085 is that the remote-control devices, which are considered to be the clinician interaction computing device 730 and patient interaction computing device 740, provide a mechanism to receive and process feedback on the operation of the implant. This is demonstrating that the two external controllers 730/740 send and receive data which includes sensor data (paragraph 0085). This is further discussed in paragraph 0089 which states that the implant telemetry circuit 534 (figure 4) communicates wirelessly with external system 402 (figure 4). The external system is considered to be 730/740 in figure 7.
On pages 12-13, within item 2, applicant argues that the programming modeling system 710 is directed towards neurostimulation programming models and parameters, and not patient information. The claim language reads:
“a patient information database communicatively coupled to the patient computing device and the clinician computing device through the patient facing application and the clinician facing application, wherein the patient information database is configured to receive the transmitted patient information”.
This language requires that the patient information database is configured to receive the transmitted patient information. As is known, databases are structured to facilitate storage, retrieval, modification and deletion of data in conjunction with data-processing operations. i Therefore, any database is capable of receiving transmitted patient information and the database of McDonald is clearly configured in a standard manner. Furthermore, McDonald’s database is considered to be 710 in figure 7 which includes model store 716, trained models 712, selection logic 718 and programs and parameters 714. In order to train models, patient data would be required. Further, at the very least, the programs and parameters are specific to the patient and can be considered to be patient information, this information is transmitted via network 720. Paragraph 0108 of McDonald further specifies that patients sensors 770 (figure 7) create sensor data 760 (figure 7) which is used by programming system 602 as inputs into executed models (which are stored in 716) to determine customized patient centric data.
Applicant argues on page 13, with respect to claim 11, that Siff/McDonald dos does not disclose claim 11. Claim 11 recites:
“wherein the patient information comprises patient information collected by the electrotherapy device and the patient facing application, and user input patient information entered into the patient facing application”
In response to this argument, patient sensors 770 (figure 7) collect data and can be included on the implanted device or external devices (paragraph 0108), this provides an example of information collected by the electrotherapy device which is sent to the patient facing application. User input is provided by 740. All of the input is used to train the models found in 710. Note that each external device is connected to 602 in figure 7 in telemetry communication.
Applicant argues on page 14 that McDonald does not teach the claim 13 language “the patient facing application is configured to provide a previously stored treatment for use by the user”. The patient facing application is a portion of the patient computing device 740. Further in paragraph 0085 the external devices, which would be 730/740 (figure 7) allow for the patient to adjust parameters for stimulation, this demonstrates that the parameters are stored, these are previously used parameters.
Applicant argues on page 16 that McDonald does not teach the claim 14 language “the clinician facing application is configured to allow the clinician to send a clinician therapy plan change to the user, through the patient facing application” and that changes include “at least one change to a therapy session parameter”. As is shown in figure 7, the clinician facing application found in element 730 communicates with the closed loop system 602 which then communicates with the patient programmer 720, therapy suggestions 790, program parameters 780 and sensor data 760 (figure 7). This demonstrates that the elements are in communication. Therapy suggestions 790 are communicated to the patient device 740 based on recommendations of indicated therapy suggestions, these include clinician recommendations (paragraph 0107). Clearly the clinician facing application is configured to send changes. Further programming device 302 in figure 3, which can include 730/740, includes a telemetry circuit 640 (paragraph 0092). Further 302 is described as a programming device, which would be configured to send changes via the programming system 602, via therapy suggestions 790 to patient device 740 (figure 7).
It is noted that the language “configured to” which is generally discussed above is considered in a broad light, it relies on the function it is performing and not the structure of the device itself. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use.
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 1-8 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Siff et al. US 2020/0121925 previously cited in view of McDonald US 2020/0282218 previously cited.ii
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 1iii); 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 732/730 (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”). iv
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 discloses 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 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 device 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 device 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 device 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 following 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
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 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, Benjamin Klein can be reached at 571-272-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i Britannica https://www.britannica.com/technology/database
ii 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.
iii These are considered to be overlapping ranges, see MPEP 2144.05
iv These are considered to be overlapping ranges, see MPEP 2144.05
Prosecution Insights