CTNF 18/915,076 CTNF 85932 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. Double Patenting 08-30 AIA A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. 08-32 Claim s 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim s 1-8 and 11-18 of copending Application No. 18/915,053 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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. 07-15-aia AIA Claim(s) 1-3, 9, 11-13 and 19 are is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Goetz (2011/0270348) . Regarding claim 1, Goetz discloses a method for programming electrical stimulation parameters for providing deep brain stimulation (DBS) to a subject patient, wherein the subject patient is implanted with an implantable medical device comprising an implantable pulse generator (IPG) connected to one or more electrode leads implanted in the subject patient’s brain, wherein each electrode lead comprises a plurality of electrodes, the method comprising: receiving imaging data for the subject patient (receive image-driven information entry – [0080]), using the imaging data to determine a position of at least one of the electrode leads with respect to at least one anatomical feature of a brain structure of the subject patient’s brain (may specify lead implant location by placing lead graphics on an image of the brain – [0080]), receiving accumulated data from a database, wherein the accumulated data comprises data from previous patients relating electrode lead position with respect to at least one anatomical feature of a brain structure of the previous patients’ brains to stimulation parameters providing therapeutic benefits in the previous patients (the lead implant location information may be stored in IMD 4 or may be available from a previous programming session and stored in memory – [0077]; the default settings may be the stimulation parameter values from the most recent programming session or the default settings may be the stimulation parameter values believed to be effective for some patients with the same condition as the patient – [0101]), and using the accumulated data and the imaging data to determine stimulation parameters for the subject patient (the default settings may be the stimulation parameter values believed to be effective for some patients with the same condition as the patient – [0101]; display model of brain functions 204 includes images of brain structures – [0083]; and adjust stimulation parameters 210 – fig.6). Regarding claim 2, Goetz discloses wherein the imaging data for the subject patient comprises preoperative magnetic resonance imaging (MRI) data and postoperative MRI data (a clinician may determine the structures of brain 16 that define a brain network by, for example, utilizing a functional magnetic resonance image (fMRI) that indicates neural activity in the brain 16 for a particular patient condition. The clinician may deliver stimulation to one structure of brain 16 and determine, based on the fMRI, what other structures of brain 16 are affected by the stimulation – [0071]). Regarding claim 3, Goetz discloses wherein the at least one anatomical feature of the subject patient’s brain structure comprises one or more of a medial border and a lateral border of the brain structure (lateral thalamus 502, medial thalamus 504 – [0102]). Regarding claim 9, Goetz disclose wherein using the accumulated data and the imaging data to determine stimulation parameters for the subject patient comprises: displaying on a graphical user interface (GUI) (102 – [0070];[0094]): a representation of a search space indicative of potential trial stimulation parameter sets (fig.4A), and one or more likelihood maps derived from the accumulated data, wherein the one or more likelihood maps indicate trial stimulation parameter sets within the search space that are likely to evoke side effects in the subject patient (processor may use a mapping algorithm to determine the stimulation parameter values that will yield the outcome or effect specified by the suer – [0095]; the processor may obtain object measures of outcomes, e.g., beneficial therapeutic effects or stimulation-induced side effects at various stimulation amplitudes – [0095]). Regarding claim 11, Goetz discloses a system for programming electrical stimulation parameters for providing deep brain stimulation (DBS) to a subject patient, wherein the subject patient is implanted with an implantable medical device comprising an implantable pulse generator (IPG) connected to one or more electrode leads implanted in the subject patient’s brain, wherein each electrode lead comprises a plurality of electrodes, the system comprising: an external computing device comprising control circuitry configured to perform a method (processor 50 may include one or more microprocessors – [0049]), the method comprising: receiving imaging data for the subject patient (receive image-driven information entry – [0080]), using the imaging data to determine a position of at least one of the electrode leads with respect to at least one anatomical feature of a brain structure of the subject patient’s brain (may specify lead implant location by placing lead graphics on an image of the brain – [0080]), receiving accumulated data from a database, wherein the accumulated data comprises data from previous patients relating electrode lead position with respect to at least one anatomical feature of a brain structure of the previous patients’ brains to stimulation parameters providing therapeutic benefits in the previous patients (the lead implant location information may be stored in IMD 4 or may be available from a previous programming session and stored in memory – [0077]; the default settings may be the stimulation parameter values from the most recent programming session or the default settings may be the stimulation parameter values believed to be effective for some patients with the same condition as the patient – [0101]), and using the accumulated data and the imaging data to determine stimulation parameters for the subject patient (the default settings may be the stimulation parameter values believed to be effective for some patients with the same condition as the patient – [0101]; display model of brain functions 204 includes images of brain structures – [0083]; and adjust stimulation parameters 210 – fig.6). Regarding claim 12, Goetz discloses wherein the imaging data for the subject patient comprises preoperative magnetic resonance imaging (MRI) data and postoperative MRI data (a clinician may determine the structures of brain 16 that define a brain network by, for example, utilizing a functional magnetic resonance image (fMRI) that indicates neural activity in the brain 16 for a particular patient condition. The clinician may deliver stimulation to one structure of brain 16 and determine, based on the fMRI, what other structures of brain 16 are affected by the stimulation – [0071]). Regarding claim 13, Goetz discloses wherein the at least one anatomical feature of the subject patient’s brain structure comprises one or more of a medial border and a lateral border of the brain structure (lateral thalamus 502, medial thalamus 504 – [0102]). Regarding claim 19, Goetz disclose wherein using the accumulated data and the imaging data to determine stimulation parameters for the subject patient comprises: displaying on a graphical user interface (GUI) (102 – [0070];[0094]): a representation of a search space indicative of potential trial stimulation parameter sets (fig.4A), and one or more likelihood maps derived from the accumulated data, wherein the one or more likelihood maps indicate trial stimulation parameter sets within the search space that are likely to evoke side effects in the subject patient (processor may use a mapping algorithm to determine the stimulation parameter values that will yield the outcome or effect specified by the suer – [0095]; the processor may obtain object measures of outcomes, e.g., beneficial therapeutic effects or stimulation-induced side effects at various stimulation amplitudes – [0095]) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 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 Claim (s) 4, 5, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goetz (2011/0270348) in view of Chiang et al (2009/0063119) . Regarding claims 4, 5, 14 and 15, Goetz discloses wherein using the imaging data to determine a position of at least one of the electrode leads with respect to at least one anatomical feature of the subject patient’s brain structure comprises using the imaging data to determine a 3-D model of the patient’s brain structure (the brain network model may include graphical representations of brain structures which may be images of the brain structure – [0083]), but fail to explicitly disclose voxelizing the 3-D model and using principal component analysis to determine one or more axes of the subject’s brain structure using the 3-D model. However, Chiang et al teach in the same medical field of endeavor, voxelizing a 3-D model (for a wireframe model, the triangle patches are converted into volumetric voxels by sampling – [0056]) and using principal component analysis to determine one or more axes of a subject patient’s brain structure using the 3-D model (each individual wireframe model is partition into several significant parts manually, and then the corresponding principal axis for each submodel is found using PCA – [0043]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the 3-D model of Goetz with voxelizing a 3-D model and using principal component analysis to determine one or more axes of a subject patient’s brain as it would provide processing the 3-D model to particularly focus on features of interest within the brain . 07-21-aia AIA Claim (s) 6-8, 10, 16-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goetz (2011/0270348) in view of Mustakos et al (2019/0329040) . Regarding claims 6 and 16, Goetz discloses the invention substantially as claimed, but fail to explicitly disclose wherein the accumulated data comprises indications of stimulation field model (SFM) radii corresponding to stimulation parameters providing therapeutic benefits in at least some previous patients. However, Mustakos et al teach in the same medical field of endeavor, wherein accumulated data comprises indications of stimulation field model (SFM) radii corresponding to stimulation parameters providing therapeutic benefits in at least some previous patients (regions determined analytically based on side effects or benefits observed in one or more patients, as well as regions specified by the user – [0077]; the parameter settings provide a stimulation field model and determining a maximum radius of the SFM for the first parameter settings, a minimum value that provides the stimulation field model that equals or approximately equals the maximum radius – claim 7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the accumulated data and SFM of Goetz with SFM radii corresponding to stimulation parameters as it would provide setting stimulation parameters based on the radii of the patient with a side effect and benefit threshold observed in one or more patients. Regarding claims 7 and 17, Goetz discloses wherein determining stimulation parameters for the subject patient comprises: receiving information indicative of a trial stimulation parameter set for the subject patient (the processor may propose settings that achieve a given desired outcome in a specific order for trial with patient – [0097]); determining an SFM for the trial stimulation parameter set (the mapping algorithm may adjust the model and parameter value predictions utilizing trial and error – [0112]), and comparing the SFM for the trial stimulation parameter set to SFM from the accumulated data (the user can adjust values for one or more stimulation values at a time in a trial and error manner until a desired therapeutic outcome is achieved – [0019]; mapping algorithm may adjust the model utilizing trial and error – [0112]), but fail to explicitly disclose determining a SFM radius for the trial stimulation parameter set. However, Mustakos et al teach in the same medical field of endeavor, determining a SFM radius for a trial stimulation parameter set (the parameter settings provide a stimulation field model and determining a maximum radius of the SFM for the first parameter settings, a minimum value that provides the stimulation field model that equals or approximately equals the maximum radius – claim 7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the trial stimulation parameter set and comparing the SFM for the trial stimulation parameter set to SFM from the accumulated data of Goetz with determining a SFM radius for the trial stimulation parameter set as it would provide optimization of stimulation based on the specific patient parameters and SFM radii. Regarding claims 8 and 18, Goetz discloses wherein the trial stimulation parameter set is automatically suggested using a stimulation optimization algorithm (the processor may propose settings that achieve a given desired outcome in a specific order for trial with patient – [0097]). Regarding claims 10 and 20, Goetz discloses wherein the one or more likelihood maps correspond to trial stimulation parameter sets that are likely to evoke side effects for the subject patient (the processor may obtain object measures of outcomes, e.g., beneficial therapeutic effects or stimulation-induced side effects at various stimulation amplitudes – [0095]), but fail to explicitly disclose SFM radii corresponding to trial stimulation parameters. However, Mustakos et al teach in the same medical field of endeavor, SFM radii corresponding to trial stimulation parameters (the parameter settings provide a stimulation field model and determining a maximum radius of the SFM for the first parameter settings, a minimum value that provides the stimulation field model that equals or approximately equals the maximum radius – claim 7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the one or more likelihood maps corresponding to trial stimulation parameter sets that are likely to evoke side effects for the subject of Goetz with SFM radii corresponding to trial stimulation parameter sets of Mustakos et al as it would provide an indication of a therapeutic threshold for a target of interest. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30. 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, Christopher Koharski can be reached at (571)272-7230. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ROCHELLE D TURCHEN/ Primary Examiner, Art Unit 3797 Application/Control Number: 18/915,076 Page 2 Art Unit: 3797 Application/Control Number: 18/915,076 Page 3 Art Unit: 3797 Application/Control Number: 18/915,076 Page 4 Art Unit: 3797 Application/Control Number: 18/915,076 Page 5 Art Unit: 3797 Application/Control Number: 18/915,076 Page 6 Art Unit: 3797 Application/Control Number: 18/915,076 Page 7 Art Unit: 3797 Application/Control Number: 18/915,076 Page 8 Art Unit: 3797 Application/Control Number: 18/915,076 Page 9 Art Unit: 3797 Application/Control Number: 18/915,076 Page 10 Art Unit: 3797 Application/Control Number: 18/915,076 Page 11 Art Unit: 3797 Application/Control Number: 18/915,076 Page 12 Art Unit: 3797
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