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 .
Claim Rejections - 35 USC § 101
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-9 are for a method, and claim 10-20 are for an apparatus. Thus, the claims are for statutory subject matter.
Step 2A, prong 1
Claims 1,10,19 include the step of determining a regression model. As stated in applicant’s specification at ¶77, such model can be an equation. The regression model is considered to be an abstract idea in the form of mathematical concepts, such as relationships, formulas, equations, etc. Additionally, the steps of identifying a volume of tissue activated and determining stimulation amplitude settings, in claims 1,10,19, can be considered to be the abstract idea of a mental process, since it can be fairly performed in the mind of the user. Further, the courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). See MPEP 2106.04(a).
Step 2A, prong 2
Claim 1 includes, other than the abstract idea, the steps of receiving anatomical information and stimulation settings. These steps are merely data gathering steps to gather data for use in the abstract idea. These additional steps fail to integrate the abstract idea into a practical application. Use of 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 integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). See MPEP 2106.05(f).
Re claim 2, the steps of determining principal axes and a distance of the VTA radius are further steps included in the abstract idea of identifying a volume of tissue, and thus do not serve to integrate the abstract idea into a practical application. Claims 3,4, also only include further steps of the abstract idea of claim 1. Claim 5 does not include any other steps than the mental step of determining stimulation amplitude, and thus does not integrate the abstract idea into a practical application. Claims 6,7 include the steps of presenting data using a user interface. Such steps are extra solution activity that do not serve to integrate the abstract idea into a practical application. Re clam 8, the step of determining a VTA radius is considered to be a further step in the above mental process, and thus does not serve to integrate the claim into a practical application. Similarly, the step of presenting is merely extra solution activity. Claim 9 only includes the step of data gathering, and thus does not further integrate the abstract idea into a practical application. Claim 10 includes, other than the abstract idea, a port, and retrieving stimulation settings. Such are used to gather data for the abstract idea, and thus do not serve to integrate the abstract idea into a practical application. Re claim 11, as mentioned, a port is used to help gather data, and thus does not integrate the abstract idea into a practical application. Re claim 12, the steps of determining a shape and a distance are both considered to be further steps in the mental step/mathematical concept set forth in claim 10. Re claims 13-18, the programming control circuit is used to further perform the mental step/mathematical process set forth in claim 10. However, as mentioned supra, using a computer to perform the mental step/mathematical process does not transform the abstract idea into patent eligible subject matter. Also, the user interface set forth in claims 16-18 is considered to be extra solution activity that does not transform the abstract idea into a practical application. Re claim 19, the steps of receiving are considered to be merely data gathering for use in the abstract idea. Thus, they do not integrate the abstract idea into a practical application. Re claim 20, the step of presenting data on a user interface is considered to be extra solution activity and thus does not serve to integrate the abstract idea into a practical application.
Step 2B
As mentioned above, the step or elements of the claims, other than the abstract idea, include receiving anatomical information, receiving stimulation settings, displaying on a user interface. Such steps and apparatus are all considered to be well understood, routine and conventional in the art, when considered by themselves or as a whole with the abstract idea. Receiving information is considered, as mentioned above, to be data gathering for use in the abstract idea, and a well-known step in order for the method/apparatus to function as intended. As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). In Flook, the Court reasoned that "[t]he notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula". 437 U.S. at 590; 198 USPQ at 197; Id. (holding that step of adjusting an alarm limit variable to a figure computed according to a mathematical formula was "post-solution activity"). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S.
The prior art does not fairly teach a method and apparatus for controlling neurostimulation including determining a regression model relating VTA to an anatomical structure, and determining stimulation amplitude settings according to the regression model.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Scott M. Getzow whose telephone number is (571)272-4946. The examiner can normally be reached M-F 9-5.
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/Scott M. Getzow/Primary Examiner, Art Unit 3792