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 .
Terminal Disclaimer
The terminal disclaimer filed on March 10, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 12,226,635 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 7-9, 11, 13, 16-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goetz et al. (US Patent Publication 20060235472 A1).
As to claims 1, 9 and 17, Goetz et al. discloses an automated neuromodulation system, comprising: a lead (Figures 1-2; [0044]), wherein the lead is implanted within a patient (Figures 1-2; [0016, 0044]), wherein the lead is connected to or near an afflicted area of the patient ([0044]); a pulse generator (depicted as 42 in Figure 2; [0059-0060]), wherein the pulse generator is implanted within a patient and is in communication with the lead (Figures 1-2; [0016]), wherein the lead applies an electrical stimulation to the afflicted area of the patient ([0044]); a processor (depicted as 44 in Figure 2; [0060-0063]) in communication with the pulse generator (Figure 2; [0060]); a sensor (depicted as 53 in Figure 2; [0065-0068]), wherein the sensor is included in one or both of the pulse generator and the lead that is implanted within the patient ([0016]), and wherein the sensor is in communication with the processor, wherein the sensor senses one or more of a position, an orientation, a movement, and a speed to produce sensor data representative of an activity of the patient ([0065-0067]); a remote control (patient programmer, depicted as 26 in Figure 1 and 3; [0049-0056], wherein the remote control is in communication with processor and with the pulse generators (Figure 1; [0049-0056]), wherein the remote control comprises at least one input (Figure 1 and 3; [0049-0056]) for providing a patient feedback to the electrical stimulation ([0048-0056]); wherein the processor processes historical patient feedback (Figures 1-2; [0048, 0052-0053, 0056, 0084]) and sensor data of the patient that occurs during execution of a training phase stimulation protocol with the pulse generator (Figure 1-3; [0048, 0052-0053, 0056, 0066, 0084]) and the lead to formulate, in accordance with a machine learning algorithm, an optimal baseline electrical stimulation protocol that is applied to the patient subsequent the training phase stimulation protocol based on current sensor data ([0016, 0046-0048, 0053-0057, 0119]; an initial, or baseline, electrical stimulation protocol is selected to be applied to the patient; “the clinician may select existing programs or specify programs by selecting program parameter values, and test the selected or specified programs on patient” [0048]), without further patient feedback ([0016-0020, 0046-0048, 0053, 0065-0068, 0119]; “In some embodiments, processor 44 may associate sensor information 54 with the one or more of programs 48 presently used by therapy delivery circuitry 42 for delivery of therapy, e.g., neurostimulation patient 12. In this manner, sensor information 54 may advantageously provide objective information regarding the efficacy or side-effects associated with delivery of therapy according to the programs. In some embodiments, processor 44 may store sensor information 54 in association with the programs within the programming history 90, or may provide the sensor information to clinician programmer 20 for inclusion in a programming history and use in providing programming guidance” [0066]).
As to claims 3, 11 and 19, Goetz et al. discloses the sensor transmits continuous sensor data to the processor during execution of a training phase protocol ([0082-0083]).
As to claim 7 and 15, Goetz et al. discloses the processor directs the pulse generator to cause the lead to deliver stimuli to the afflicted area during a portion of the execution of the training phase stimulation protocol based solely on the continuous sensor data ([0066-0067, 0104]).
As to claim 8 and 16, Goetz et al. discloses the training phase stimulation protocol is initially selected based on a known physical activity background of the patient (i.e. stored activity data or history; [0066, 0083, 0104, 0108]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 4-6, 10, 12-14, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Goetz et al. (US Patent Publication 20060235472 A1).
As to claims 2, 10 and 18, Goetz et al. discloses the invention substantially as claimed with the remote control providing “at least one input to provide a patient feedback to the electrical stimulation” but does not explicitly disclose that the at least one input of the remote control consists solely of a binary input. Binary data inputs are extremely well known in electronics and the medical device art. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the input received to consist solely of a binary input in order to provide the predictable results of optimizing the device performance and function.
As to claims 4, 12 and 20, Goetz et al. discloses “the programs selected during an initial programming session may ultimately prove to be inadequate. The eventual inadequacy of the initial programming may be due to a variety of problems, including progression of symptoms and/or an underlying ailment, increased or changed symptoms or side effects during activities and/or postures that were not replicated in the clinic during the initial programming session, slow onset of side effects and, in the case of delivery of stimulation via electrodes located on implantable leads, lead migration”([0006]). Goetz et al. discloses the importance of performing a specific activity during initial programming sessions or the training phase stimulation protocol, however Goetz et al. does not explicitly disclose the processor prompts the patient, via the remote control, to perform a specific activity during the training phase stimulation protocol. It would have been obvious to one having ordinary skill in the art at the time the invention was made to include processor that prompts the patient, via the remote control, to perform a specific activity during the training phase stimulation protocol in order to provide the predictable results of providing appropriate stimulation by replicating activities or postures that would affect the initial programming or training phase stimulation to meet specific patient therapeutic needs and requirements.
As to claim 5 and 13, the modified Goetz et al., as applied to claims 4, 12 and 20 above, discloses the invention substantially as claimed but does not explicitly disclose the type of prompt. However, in order to communicate to the patient, the prompt would necessarily have to engage with at least one of the patient’s senses (via audio, visual or tactile). Therefore, since the modified Goetz et al. is considered to prompt the patient, in order to be effective, the prompt would necessarily be “a visible light prompt, a vibration prompt, or an audible prompt”.
As to claims 6 and 14, the modified Goetz et al., as applied to claims 4, 12 and 20 above, discloses the invention substantially as claimed with a prompt to the patient, but does not explicitly discloses the prompt of the patient occurs after a predetermined amount of time has passed without the patient feedback. Time windows or limits for receiving inputs is extremely well known in electronics (ex. sleep mode in electronics after inactivity for a certain duration). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a timed window for receiving patient feedback and in the event that no feedback is submitted, prompt the patient in order to provide the predictable results of ensuring sufficient operation and optimization of the treatment to meet specific patient therapeutic needs and requirements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached on (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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