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 .
Status of Claims
Claims 1-20 has been considered and are addressed below.
Response to Arguments/Amendments
Applicant’s amendments filed on 2-12-26 has been entered and are addressed below.
Applicant argues that the claims as a whole are directed to technological solutions. Examiner respectfully disagrees. Examiner respectfully disagrees. The claim as a whole does not improve computer technology, rather it performs an analysis based on data received on trials, which falls under certain methods of organizing human activity (the patient and the system interacting) and mental process (gathering, analyzing and presenting analyzed data).
Applicant argues that the prior art does not teach reprogramming an implantable device that is operating over a predetermined time period comprising a plurality of consecutive days for each trial program of the one or more trial programs, wherein the application automatically progresses from a first trail program to a second trail program after completion of the predetermined time period for the first trail program without patient input. The argument is moot in view of applicant’s amendments to the claims and are addressed below.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-20 are drawn to a computer implemented method which is/are statutory categories of invention (Step 1: YES).
Independent claim 1, 13, 16, recite “entering a reprograming mode”, “displaying one or more programs in response to receiving an initial patient efficacy rating of a current program below a threshold”, “calibrating the one or more trial programs”, “receiving a patient efficacy rating for each trial program of the one or more trail programs”, “determining if at least one trial program of the one or more trial programs meet the predetermined pain management standard”.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover mental process. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including a “entering a reprograming mode via an assistant in an application running on a patient remote control wherein the patient remote control includes a user interface”, “successively operating an implantable medical device in accordance with a set of parameters of each trail program of the one or more trial programs over a predetermined time period” which are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed (e.g., the “processor” language is incidental to what it is “configured” to perform). Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The claims recite the additional element of “displaying on a user interface of the patient remote control one or more trial programs wherein the trails programs are displayed in response to receiving an initial patient efficacy rating of a current program below a predetermined threshold”, which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
Paragraph 12 recite “an implantable medical device, remote control comprising a memory, a user interface for receiving inputs from and providing instructions or information to a patient, and a processor including a communication circuit for communicating with the implantable medical device, the memory storing in non-transitory manner instructions for performing the preceding methods to reprogram an implantable medical device”.
Paragraph 29 recites “The RC 16 may be used by a patient to enable or disable therapy programs, to select between available programs, and/or to modify the programs that are available for use. For example, in some embodiments a patient may use the RC 16 to activate a stored program and then manipulate therapy by increasing or decreasing therapy strength and/or changing therapy location, within limits set by the physician. The RC 16 may be a custom device, or may be, for example, a smartphone or tablet having an application thereon for use with the medical device system 10”.
The claims recite the additional element of “displaying on a user interface of the patient remote control one or more trial programs wherein the trails programs are displayed in response to receiving an initial patient efficacy rating of a current program below a predetermined threshold”, which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-12, 14-15, 17-20 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein. Additionally, the devices mentioned in dependents claim are used as input devices.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kraiter (US 2021/0077017) in view of Nabutovsky (2015/0273215) and Rauch (US 11576966).
With respect to claim 1 Kraiter teaches a method for reprogramming an implantable medical device, the method comprising entering a reprogramming mode via an assistant in an application running on a patient remote control, wherein the patient remote control includes a user interface, and, while in said reprogramming mode (Kraiter paragraph 60 “of a software interface (e.g. implemented on the first device 2 and displayed on display 20) for the technical user (e.g. physician/clinician) P2 who is performing the assessment and potential re-programming. As shown, the technical user P2 is able to view details about the presently delivered stimulation parameter set. The technical user P2 can see in real time the present composite pain score PS and a history of average composite pain scores obtained during previous stimulation set tests” reads on the limitation additionally paragraph 46 recites a patient remote control):
displaying on the user interface of the patient remote control one or more trial programs, wherein the one or more trial programs are displayed in response to receiving an initial patient efficacy rating (Kraiter paragraph 45 “the system 1 comprises a first device 2 associated to a technical user such as a physician P2 or a clinician, a second device 3 associated to a patient P1, a medical device 4 associated to the patient P1, which medical device 4 is particularly implanted into the patient P1, wherein the second device 3 is configured to communicate with the medical device 4, and wherein the medical device 4 is configured to be programmed via the second device 3, wherein the first device 2 is further configured to communicate with the second device 3, and wherein the second device 3 is configured to be controlled via the first device 2, and wherein the second device 3 is configured to acquire data S1, S2 indicative of at least one physiological parameter HR, F, P or of several physiological parameters of the patient P1, and wherein the first device 2 is configured to display (e.g. via a display 20 of the first device 2) at least one of said data S1, S2, said at least one physiological parameter HR, F, P, said several physiological parameters, or a quantity derived from said data S1, S2.” And paragraph 46 “Whether through direct control or through instruction to the patient P1, the stimulation parameters for the medical device 4 are adjusted”, which reads on the receiving an efficacy rating);
calibrating the one or more trial programs (Kraiter paragraph 26 “wherein particularly the first device is configured to determine said posture by analyzing changes in a sitting position of the patient relative to a reference body outline that can be calibrated with respect to the patient” which reads on the recited limitation);
successively operating an implantable medical device in accordance with a set of parameters of each trial program of the one or more trial programs over a predetermined time period (Kraiter paragraph 60 “the technical user P2 is able to view details about the presently delivered stimulation parameter set. The technical user P2 can see in real time the present composite pain score PS and a history of average composite pain scores obtained during previous stimulation set tests”);
receiving a patient efficacy rating for each trial program of the one or more trial programs (Kraiter paragraph 60 “”he technical user P2 can see the individual physiologic parameters that are used in calculating the pain score; in this case, the parameters are heart rate HR, facial expression F (e.g. derived from length and/or number of wrinkles of the facial skin of the patient P1), and posture P. The technical user P2 is able to view a historical trend of these variables HR, F, P that gets updated in real time. This allows the technical user P2 to incorporate his own judgement into interpretation of the data in addition to looking at the composite pain score PS outputs); and
determining if at least one trial program of the one or more trial programs meets a predetermined acceptable pain management standard (Kraiter paragraph 62 “This reference can be used as a basis for comparison of the physiological parameters when each stimulation is delivered. In one embodiment, an absolute pain score can be entered according to patient feedback for this baseline period. This absolute value of manually-entered pain score can be used as a calibration for reporting all assessed pain levels relative to the starting pain score. Calibration setup also includes the ability to identify reference markings on the face or body of the patient to optionally aid with facial or posture analysis processing”).
Kraiter does not teach a current program below a predetermined threshold.
Nabutovsky teaches if patient activity remains below a threshold indicative of “activity,” HR, GSR and BP are then assessed at steps 412, 414 and 416, respectively, for comparison against corresponding pre-determined inactivity baseline values, i.e. baseline values for HR, GSR and BP obtained during periods of patient inactivity (Nabutovsky paragraph 38).
One of ordinary skill at the time of filing would have found it obvious the teachings of Kraiter with Nabutovsky with a motivation of providing improved trial neurostimulation devices (Nabutovsky paragraph 4).
Kraiter in view of Nabutovsky does not explicitly teach comprising a plurality of consecutive days for each trial program of the one or more trial programs, wherein the application automatically progresses from a first trial program to a second trial program after completion of the predetermined time period for the first trial program without patient input.
Rauch teaches inquire about the subject's general well-being and to assess safety 1 day after the first trial vaccination …. Clinic Visit 2: Day 29—Second Trial Vaccination (˜3/+7 days) Pre-vaccination Procedures Review and record any newly reported safety data including solicited and unsolicited AEs, or other AEs (medically-attended AEs, SAEs). Record concomitant medications and vaccinations, including recurring medications for intermittent conditions. Perform a symptom-directed physical examination (see Section 9.3.7). Measure vital signs (body temperature, pulse, blood pressure, see Section 9.3.7). (Rauch column 241 lines 33-34 and column 242 lines 32-40.
One of ordinary skill in the art would have found it obvious to combine the teachings of Kraiter in view of Nabutovsky with Rauch at the time of filing with the motivation of a safe and effective treatment (Raunch column 2 lines 8-10).
Claim 13 is rejected as above.
Claim 16 is rejected as above.
With respect to claim 2 Kraiter in view of Nabutovsky teaches the method of claim 1, wherein the initial patient efficacy rating is received in response to entering the reprogramming mode (Kraiter paragraph 19 “instructing the (e.g. implantable) medical device can comprise sending data to the medical device, sending current therapy settings to the medical device, send physiological parameters (stored or real-time) to the medical device, changing therapy settings, starting therapy delivery by the medical device”).
Claim 17 is rejected as above.
With respect to claim 3 Kraiter in view of Nabutovsky teaches the method of claim 1, wherein the reprogramming mode is entered in response to receiving a patient input at the user interface of the patient remote control (Kraiter paragraph 46 “The physician/clinician P2 or a designated representative providing follow-up care of the patient's medical device 4 (here e.g. an implantable medical device 4 configured for neurostimulation, particularly spinal cord stimulation) is able to connect to the second device 3 e.g. via a web portal accessed via the first device 2. Optionally, the physician P2 may also be able to initiate direct control of the active stimulation. Whether through direct control or through instruction to the patient P1, the stimulation parameters for the medical device 4 are adjusted; and the video stream S1, i.e. a sequence of optical images S1 generated by the second device 3, is used, particularly supplemented by verbal communication, to assess the present pain level of the patient P1 with each stimulation parameter iteration. Exemplary stimulation parameters are: Choice of electrodes of a multiple electrode lead, stimulation frequency, stimulation pulse width, stimulation amplitude, patterns of stimulation cycling or combinations of stimulation electrodes.”).
With respect to claim 4 Kraiter in view of Nabutovsky teaches the method of claim 1, wherein the initial patient efficacy rating is received during routine monitoring of the implantable medical device (Kraiter paragraph 26 “the first device is configured to analyze said optical image or sequence of optical images to determine at least one or several of the following physiological parameters mentioned above: a heart rate of the patient, wherein particularly the first device is configured to determine the heart rate from cyclical fluctuations in the light reflection of the facial skin of the patient”).
Claim 18 is rejected as above.
With respect to claim 5 Kraiter in view of Nabutovsky teaches the method of claim 1, wherein the application is configured to enter the reprogramming mode in response to the initial patient efficacy rating (Kraiter paragraph 62 “the technical user P2 may have functions available that can be used for calibrating the setup prior to evaluating stimulation parameter sets. Prior to running a stimulation test, a baseline assessment period can be used to collect reference data for the individual patient. This reference can be used as a basis for comparison of the physiological parameters when each stimulation is delivered. In one embodiment, an absolute pain score can be entered according to patient feedback for this baseline period. This absolute value of manually-entered pain score can be used as a calibration for reporting all assessed pain levels relative to the starting pain score. Calibration setup also includes the ability to identify reference markings on the face or body of the patient to optionally aid with facial or posture analysis processing”).
With respect to claim 6 Kraiter in view of Nabutovsky teaches the method of claim 1, further comprising selecting a trial program that meets the predetermined pain management standard (Kraiter paragraph 62 “Prior to running a stimulation test, a baseline assessment period can be used to collect reference data for the individual patient. This reference can be used as a basis for comparison of the physiological parameters when each stimulation is delivered. In one embodiment, an absolute pain score can be entered according to patient feedback for this baseline period. This absolute value of manually-entered pain score can be used as a calibration for reporting all assessed pain levels relative to the starting pain score. Calibration setup also includes the ability to identify reference markings on the face or body of the patient to optionally aid with facial or posture analysis processing”).
With respect to claim 7 Kraiter in view of Nabutovsky teaches the method of claim 6, further comprising transmitting the selected trial program to the implantable medical device (Kraiter paragraph 16 “particularly, the first device associated to the physician is configured to instruct the second device to transmit the (e.g. pre-processed) data to the first device associated to the physician.”).
Claim 15 is rejected as above.
With respect to claim 8 Kraiter in view of Nabutovsky teaches the method of claim 1, wherein the one or more trial programs are selected from a plurality of anatomical based programs or paresthesia-based programs based off of a reference program (Kraiter paragraph 47 “Posture P, which is extracted by analyzing changes in sitting position relative to a reference body outline that can be calibrated for the patient”).
Claim 19 is rejected as above.
With respect to claim 9 Kraiter in view of Nabutovsky teaches the method of claim 1, wherein calibrating the one or more trial programs comprises increasing a stimulus until a paresthesia response is felt for each trial program of the one or more trial programs (Kraiter paragraph 59 “first device 2 may also send program information down to the second device 3, which then sends the programming to the medical device (here IPG) 4, e.g. for changing stimulation parameters of the neurostimulation of the patient (e.g. spinal cord stimulation). The first device 2 can perform a video analysis and can display information for the medical personal P2 (e.g. physician/clinician etc.), which is detailed further below.”).
Claim 20 is rejected as above.
With respect to claim 10 Kraiter in view of Nabutovsky teaches the method of claim 9, wherein calibrating the one or more trial programs is performed in one or more postures (Kraiter paragraph 33 “wherein particularly the first device determines said state using a pupil tracking algorithm carried out by the first device; a posture of the patient,”).
With respect to claim 11 Kraiter in view of Nabutovsky teaches the method of claim 9, wherein calibrating the one or more trial programs determines a therapeutic amplitude for each trial program of the one or more trial programs (Kraiter paragraph 46 “Exemplary stimulation parameters are: Choice of electrodes of a multiple electrode lead, stimulation frequency, stimulation pulse width, stimulation amplitude, patterns of stimulation cycling or combinations of stimulation electrodes”).
With respect to claim 12 Kraiter in view of Nabutovsky teaches the method of claim 1, wherein if at least one trial program of the one or more trial programs fails to meet a predetermined acceptable pain management standard, one or more additional trial programs are presented (Kraiter paragraph 46 “Whether through direct control or through instruction to the patient P1, the stimulation parameters for the medical device 4 are adjusted; and the video stream S1, i.e. a sequence of optical images S1 generated by the second device 3, is used, particularly supplemented by verbal communication, to assess the present pain level of the patient P1 with each stimulation parameter iteration”).
Claim 14 is rejected as above.
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 REGINALD R REYES whose telephone number is (571)270-5212. The examiner can normally be reached 8:00-4:30 M-F.
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, Shahid R. Merchant can be reached at (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REGINALD R. REYES
Primary Examiner
Art Unit 3684
/REGINALD R REYES/Primary Examiner, Art Unit 3684
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