CTNF 18/915,065 CTNF 87965 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. Specification 07-29-04 The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See Paragraph [0052]. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 an abstract idea using a mental process without significantly more. The claim(s) recite(s) a mental process of receiving data from a database including previous trial parameter sets, SFMs (models) and score of therapeutic effectiveness, and aggregating the SFMs of each stored trial stimulation parameters having a score exceeding a threshold or within a defined threshold range, determining an overlap of the aggregated SFMs and use the overlap to determine electrical stimulation parameters. This judicial exception is not integrated into a practical application because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., external computing device comprising control circuitry as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 11 (and their respective dependent claims) is not integrated into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these claims require the additional elements of: an external computing device comprising control circuitry are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am. , Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs. , 788 F.3d at 1363, 115 USPQ2d at 1092-93. Per Applicant’s specification, the clinician programmer software 84 in the computing device 72 can be facilitated by control circuitry 88 such as one or more microprocessors, microcomputers, FPGAs, DSPs, other digital logic structures, etc., which are capable of executing programs in a computing device, and which may comprise their own memories. For example, control circuitry 88 can comprise an i5 processor manufactured by Intel Corp, as described at https://www.intel.com/content/www/us/en/products/processors/core/i5-processors.html. Such control circuitry 88, in addition to executing the clinician programmer software 84 and rendering the GUI 100, can also enable communications via antennas 80a or 80b to communicate stimulation parameters chosen through the GUI 100 to the patient's IPG 10. Accordingly, in light of Applicant’s specification, the claimed term an external computing device comprising control circuitry is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the external computing device comprising control circuitry. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “ ‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible ( TLI Communications ). The recitation of the above-identified additional limitations in Claims 1-20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV , 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto , LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc. , 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp. , 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016) , the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Allowable Subject Matter Claims 1-20 are rejected under 35 U.S.C. 101 as identified above. Regarding the closest prior art. Kemmerer et al (US Publication 2016/0250476) discloses a receiving therapy data (94) from a database, along with SFMs (stored VTA) and scores (148) for each therapy program and using the scores to determine at least one therapy program (150). However, the cited reference fail to individually disclose, or suggest when combined, an aggregating the SFMs of each of the trial stimulation parameter sets having a score exceeding a threshold score or within a defined threshold range, determining an overlap of the aggregated SFMs, and using the overlap to determine electrical stimulation parameters for the subject patient Mustakos et al (US Publication 2017/0372039) discloses a system for visualizing clinical effects by obtaining stimulation instances and effect/side effect (score) and estimating the effective region SFM given the position of the lead and its electrodes used to generate the stimulation. Paragraph [0039] discloses sets of stimulation parameters, used in the stimulation of one or more patients, and the therapeutic effects or side-effects resulting for the respective set of stimulation parameters can be recorded and associated with the corresponding SFM for that set of stimulation parameters. Paragraph [0040] discloses the clinical effects data (therapeutic effects and optionally side-effects) from multiple patients, multiple SFMs, or any combination thereof can be aggregated to provide information about anatomical regions and the likelihood that stimulation of the region will produce a therapeutic effect or side effect. These likelihoods can be visualized, for example, on an anatomical display or in an anatomical atlas to provide guidance to a clinician for selection of anatomical regions to stimulate. However, the cited reference fail to individually disclose, or suggest when combined, an aggregating the SFMs of each of the trial stimulation parameter sets having a score exceeding a threshold score or within a defined threshold range, determining an overlap of the aggregated SFMs, and using the overlap to determine electrical stimulation parameters for the subject patient. Moffitt (US Publication 2012/0165898) discloses scoring a simulated volume of tissue (e.g. Paragraph [0019]) and selecting stimulation parameters based on the automatic scoring (e.g. Paragraph [0054]). However, the cited reference fail to individually disclose, or suggest when combined, an aggregating the SFMs of each of the trial stimulation parameter sets having a score exceeding a threshold score or within a defined threshold range, determining an overlap of the aggregated SFMs, and using the overlap to determine electrical stimulation parameters for the subject patient However, no prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically aggregating the SFMs of each of the trial stimulation parameter sets having a score exceeding a threshold score or within a defined threshold range, determining an overlap of the aggregated SFMs, and using the overlap to determine electrical stimulation parameters for the subject patient in combination with the recited structural limitations of the claimed invention. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM 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, David Hamaoui can be reached at (571)270-5625. 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. /William J Levicky/Primary Examiner, Art Unit 3796 Application/Control Number: 18/915,065 Page 2 Art Unit: 3796 Application/Control Number: 18/915,065 Page 3 Art Unit: 3796 Application/Control Number: 18/915,065 Page 4 Art Unit: 3796 Application/Control Number: 18/915,065 Page 5 Art Unit: 3796 Application/Control Number: 18/915,065 Page 6 Art Unit: 3796 Application/Control Number: 18/915,065 Page 7 Art Unit: 3796 Application/Control Number: 18/915,065 Page 8 Art Unit: 3796
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