CTNF 18/931,821 CTNF 95411 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-aia AIA 1. Claim(s) 1, 3-5, 7-12, and 14-20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Gliner (US 20040249422 A1) . In regards to claims 1 and 20 , Gliner discloses a method/system for operating an implantable stimulator device having a plurality of electrodes configured for implantation in a patient’s brain ( Abstract and Par. 0010 teach implantable electrodes as a part of a deep brain stimulation system ), comprising: providing stimulation to the patient as pulses in packets at at least one of the electrodes ( Par. 0050 teaches applying a pulse train, i.e. packet, by the electrodes ), wherein the pulses in each packet comprise a number of N pulses issued at a first frequency, wherein N equals two or greater, wherein the packets are issued at a second frequency ( Par. 0050 discloses that there are a number of pulses delivered in each train, i.e. there are two or more pulses. Par. 0066 and Fig 6 also teach that each pulse train can have different frequencies ); receiving a first measurement concerning a first symptom of the patient to assess the effect of the stimulation on the first symptom; receiving a second measurement concerning a second symptom of the patient to assess the effect of the stimulation on the second symptom ( Par. 0053-0058 and Fig 3 teaches taking in measurements from the patient during stimulation application and measuring if there is relief concerning a first and additional subset of symptoms ); in response to the first measurement, adjusting the stimulation by adjusting either or both of (i) the first frequency of the pulses in each packet, or (ii) the number N of pulses provided in each packet; and in response to the second measurement, adjusting the stimulation by adjusting the second frequency at which the packets are issued (Par. 0055-0058 and Fig 2 teach taking in these measurements and then adjusting the stimulation parameters based on this. Par. 0058 teaches that the pulse repetition frequency can be adjusted ). In regards to claim 3 , Gliner discloses the method of claim 1, wherein the first symptom comprises patient tremor ( Par. 0038 teaches the symptom can be a patent tremo r). In regards to claim 4 , Gliner discloses the method of claim 3, wherein the second symptom comprises freezing of gait ( Par. 0005 teaches that one of the symptoms could be gait or balance problems ). In regards to claim 5 , Gliner discloses the method of claim 1, wherein in response to the first measurement, the first frequency is increased ( Par. 0095 discloses that for adjustments the frequency can be increased ). In regards to claim 7 , Gliner discloses the method of claim 1, wherein in response to the second measurement, the second frequency is decreased (Par. 0058 teaches that the adjustment can be decreasing the frequency ) In regards to claim 8 , Gliner discloses the method of claim 1, wherein either or both of the first measurement or the second measurement is made using the implantable stimulator device ( Par. 0041 and Fig 1 discloses that the measurements can be taken by the electrodes [140] of the implantable device ) In regards to claim 9 , Gliner discloses the method of claim 1, wherein either or both of the first measurement or the second measurement is made using at least one sensor separate from the implantable stimulator device (Par. 0038 teaches that the measurements can be taken by EEGs, ECOGs, or MEGs external to the implanted stimulator ). In regards to claim 10 , Gliner discloses the method of claim 9, wherein the at least one sensor comprises a motion sensor, or wherein the at least one sensor is configured to be wearable by the patient ( Par. 0038 teaches using acetometers to measure the motion of a patient). In regards to claim 11 , Gliner discloses the method of claim 1, wherein the first measurement and the second measurement are received at an external system in communication with the implantable stimulator device ( Par. 0034 teaches receiving communications to an external device/user interface ) In regards to claim 12 , Gliner discloses the method of claim 11, wherein the stimulation is adjusted using telemetry from the external system ( Par. 0034 teaches this communication is done through telemetric signal transfer ). In regards to claim 14 , Gliner discloses the method of claim 1, wherein the stimulation is adjusted automatically ( Par. 0083 ). In regards to claim 15 , Gliner discloses the method of claim 1, wherein either or both of the first measurement and the second measurement comprise an objective measurement ( The Applicant’s specification indicates that objective measurements are made by sensors and Par. 0038 of Gliner teaches making measurements using sensors ) In regards to claim 16 , Gliner discloses the method of claim 1, wherein the pulses in each packet are actively-driven monophasic pulses and of a single polarity (Par. 0051 teaches the pulses can be monophasic and the polarity can be adjusted/correspond as needed ). In regards to claim 17 , Gliner discloses the method of claim 1, wherein the pulses in each packet are actively-driven biphasic pulses comprising first and second phases of opposite polarities ( Par. 0050 teaches applying biphasic pulses and Par. 0051 teaches having specific polarities as needed/corresponding to the pulses ). In regards to claim 18 , Gliner discloses the method of claim 1, wherein the pulses in each packet are actively-driven and charge balanced at the at least one of the electrode (Par. 0051 discloses that the trains are charge balanced. Par. 0036 teaches that the pulses are controlled, i.e, actively driven ). In regards to claim 19 , Gliner discloses the method of claim 1, wherein the implantable stimulator device comprises a case electrode, wherein the stimulation is monopolar using the case electrode as a current return (Par. 0035 teaches a case for the implantable device that has return electrodes on it) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA 2. Claim (s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gliner in view of Esteller (US 20190099602 A1) . In regards to claim 2 , Gliner discloses the method of claim 1, except for wherein in response to the first measurement, adjusting both (i) the first frequency of the pulses in each packet, and (ii) the number N of pulses provided in each packet. While Gliner discloses adjusting frequency, they do not disclose wherein the adjustment can be both frequency and number of pulses. However, in the same field of endeavor, Esteller discloses an implantable pulse generator for deep brain stimulation ( Abstract and Par. 0003 ) wherein during stimulation, parameters such as the number of pulses and the pulse frequency can be adjusted ( Par. 0082) in order to better alleviate the patient’s symptoms ( Par. 0079 ). Therefore, it may be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Gliner and modified them by adjusting both the pulse frequency and number of pulses, as taught and suggested by Esteller, in order to better alleviate the patient’s symptoms ( Par. 0079 of Esteller ) . 07-21-aia AIA 3. Claim (s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gliner in view of Rennaker II (US 20180085578 A1) . In regards to claim 6 , Gliner discloses the method of claim 1, except for wherein in response to the first measurement, the number N of pulses provided in each packet is increased. However, in the same field of endeavor, Rennaker II discloses a method for deep brain stimulation for tremor treatment ( Abstract and Par. 0004 ) wherein the number of pulses in a pulse train can be increased ( Par. 0099 ) in order to adjust the stimulation to correlate to the patient’s specific needs ( Par. 0102 ). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Gliner and modified them by increasing the number of pulses in the pulse train, as taught and suggested by Rennaker II, in order to adjust the stimulation to correlate to the patient’s specific needs ( Par. 0102 of Rennaker II) . 07-21-aia AIA 4. Claim (s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gliner in view of Giuffrida (US 20140005743 A1) . In regards to claim 13 , Gliner discloses the method of claim 11, wherein either or both of the first measurement and the second measurement are manually received at a user interface of the external device ( Par. 0034 teaches that these measurements are sent to a user interface), Gliner does not disclose wherein either or both of the first measurement and the second measurement comprise a subjective score indicative of the first symptom. However, in the same field of endeavor, Giuffrida discloses a method for deep brain stimulation ( Abstract ) wherein a practitioner measures and scores the patients symptoms during the stimulation ( Par. 0142 ) in order to determine if the stimulation is improving the patient’s symptoms ( Par. 0142 ). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Gliner and modified them by creating a symptom score during the stimulation, as taught and suggested by Giuffrida, in order to determine if the stimulation is improving the patient’s symptoms ( Par. 0142 ). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 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, Niketa Patel can be reached at (571) 272-4156. 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. /S.L.C./Examiner, Art Unit 3792 /LYNSEY C Eiseman/Primary Examiner, Art Unit 3796 Application/Control Number: 18/931,821 Page 2 Art Unit: 3792 Application/Control Number: 18/931,821 Page 3 Art Unit: 3792 Application/Control Number: 18/931,821 Page 4 Art Unit: 3792 Application/Control Number: 18/931,821 Page 5 Art Unit: 3792 Application/Control Number: 18/931,821 Page 6 Art Unit: 3792 Application/Control Number: 18/931,821 Page 7 Art Unit: 3792
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